Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements

 
CONTENT
Federal Register, Volume 84 Issue 138 (Thursday, July 18, 2019)
[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Proposed Rules]
[Pages 34598-34715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14913]
[[Page 34597]]
Vol. 84
Thursday,
No. 138
July 18, 2019
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 409, 414, and 484
Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment
System Rate Update; Home Health Value-Based Purchasing Model; Home
Health Quality Reporting Requirements; and Home Infusion Therapy
Requirements; Proposed Rule
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 /
Proposed Rules
[[Page 34598]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 414, and 484
[CMS-1711-P]
RIN 0938-AT68
Medicare and Medicaid Programs; CY 2020 Home Health Prospective
Payment System Rate Update; Home Health Value-Based Purchasing Model;
Home Health Quality Reporting Requirements; and Home Infusion Therapy
Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would update the home health prospective
payment system (HH PPS) payment rates and wage index for CY 2020;
implement the Patient-Driven Groupings Model (PDGM), a revised case-mix
adjustment methodology, for home health services beginning on or after
January 1, 2020. This proposed rule also implements a change in the
unit of payment from 60-day episodes of care to 30-day periods of care,
as required by section 51001 of the Bipartisan Budget Act of 2018,
hereinafter referred to the ``BBA of 2018'', and proposes a 30-day
payment amount for CY 2020. Additionally, this proposed rule proposes
to: Modify the payment regulations pertaining to the content of the
home health plan of care; allow physical therapy assistants to furnish
maintenance therapy; and change the split percentage payment approach
under the HH PPS. This proposed rule would also solicit comments on the
wage index used to adjust home health payments and suggestions for
possible updates and improvements to the geographic adjustment of home
health payments. In addition, it proposes public reporting of certain
performance data under the Home Health Value-Based Purchasing (HHVBP)
Model. We are proposing to publicly report the Total Performance Score
(TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY
2020) Annual TPS and Payment Adjustment Report for each home health
agency in the nine Model states that qualified for a payment adjustment
for CY 2020. It also proposes changes with respect to the Home Health
Quality Reporting Program to remove one measure, to adopt two new
measures, modify an existing measure, adopt new standardized patient
assessment data beginning with the CY 2022 HH QRP, codify the HH QRP
policies in a new section, and to remove question 10 from all the HH
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
surveys. Lastly, it would set forth routine updates to the home
infusion therapy payment rates for CY 2020 and propose payment
provisions for home infusion therapy services for CY 2021 and
subsequent years.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 9,
2019.
ADDRESSES: In commenting, please refer to file code CMS-1711-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
    1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
    2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1711-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1711-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Kelly Vontran, (410) 786-0332, for
Home Health Prospective Payment System (HH PPS) or home infusion
payment.
    For general information about the Home Health Prospective Payment
System (HH PPS), send your inquiry via email to:
[email protected].
    For general information about home infusion payment, send your
inquiry via email to: [email protected].
    For information about the Home Health Value-Based Purchasing
(HHVBP) Model, send your inquiry via email to:
[email protected].
    For information about the Home Health Quality Reporting Program (HH
QRP), send your inquiry via email to [email protected].
SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Table of Contents
I. Executive Summary
    A. Purpose
    B. Summary of the Major Provisions
    C. Summary of Costs and Benefits
II. Overview of the Home Health Prospective Payment System (HH PPS)
    A. Statutory Background
    B. Current System for Payment of Home Health Services
    C. New Home Health Prospective Payment System for CY 2020 and
Subsequent Years
    D. Analysis of CY 2017 HHA Cost Report Data
III. Proposed Provisions for Payment Under the Home Health
Prospective Payment System (HH PPS)
    A. Implementation of the Patient-Driven Groupings Model (PDGM)
for CY 2020
    B. Implementation of a 30-Day Unit of Payment for CY 2020
    C. Proposed CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes
of Care Spanning Implementation of the PDGM
    D. Proposed CY 2020 PDGM Case-Mix Weights and Low-Utilization
Payment Adjustment (LUPA) Thresholds
    E. Proposed CY 2020 Home Health Payment Rate Updates
    F. Proposed Payments for High-Cost Outliers Under the HH PPS
    G. Proposed Changes to the Split-Percentage Payment Approach for
HHAs in CY 2020 and Subsequent Years
    H. Proposed Change To Allow Therapist Assistants To Perform
Maintenance Therapy
    I. Proposed Changes to the Home Health Plan of Care Regulations
at Sec.  409.43
IV. Proposed Provisions of the Home Health Value-Based Purchasing
(HHVBP) Model
    A. Background
    B. Public Reporting of Total Performance Scores and Percentile
Rankings Under the HHVBP Model
    C. CMS Proposal To Remove Improvement in Pain Interfering With
Activity Measure (NQF #0177)
V. Proposed Updates to the Home Health Quality Reporting Program (HH
QRP)
    A. Background and Statutory Authority
[[Page 34599]]
    B. General Considerations Used for the Selection of Quality
Measures for the HH QRP
    C. Quality Measures Currently Adopted for the CY 2021 HH QRP
    D. Proposed Removal of HH QRP Measures Beginning With the CY
2022 HH QRP
    E. Proposed New and Modified HH QRP Quality Measures Beginning
With the CY 2022 HH QRP
    F. HH QRP Quality Measures, Measure Concepts, and Standardized
Patient Assessment Data Elements Under Consideration for Future
Years: Request for Information
    G. Proposed Standardized Patient Assessment Data Reporting
Beginning with the CY 2022 HH QRP
    H. Proposed Standardized Patient Assessment Data by Category
    I. Form, Manner, and Timing of Data Submission Under the HH QRP
    J. Proposed Codification of the Home Health Quality Reporting
Program Requirements
    K. Home Health Care Consumer Assessment of Healthcare Providers
and Systems (CAHPS[supreg]) Survey (HHCAHPS)
VI. Medicare Coverage of Home Infusion Therapy Services
    A. Background and Overview
    B. CY 2020 Temporary Transitional Payment Rates for Home
Infusion Therapy Services
    C. Proposed Home Infusion Therapy Services for CY 2021 and
Subsequent Years
    D. Proposed Payment Categories and Amounts for Home Infusion
Therapy Services for CY 2021
    E. Required Payment Adjustments for CY 2021 Home Infusion
Therapy Services
    F. Other Optional Payment Adjustments/Prior Authorization for CY
2021 Home Infusion Therapy Services
    G. Billing Procedures for CY 2021 Home Infusion Therapy Services
VII. Collection of Information Requirements
VIII. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    D. Detailed Economic Analysis
    E. Alternatives Considered
    F. Accounting Statement and Tables
    G. Regulatory Reform Analysis Under E.O. 13771
    H. Conclusion
    Regulation Text
I. Executive Summary
A. Purpose
1. Home Health Prospective Payment System (HH PPS)
    This proposed rule would update the payment rates for home health
agencies (HHAs) for calendar year (CY) 2020, as required under section
1895(b) of the Social Security Act (the Act). This proposed rule would
also update the case-mix weights under section 1895(b)(4)(A)(i) and
(b)(4)(B) of the Act for 30-day periods of care beginning on or after
January 1, 2020. This rule would also implement the PDGM, a revised
case-mix adjustment methodology that was finalized in the CY 2019 HH
PPS final rule (83 FR 56406), which would also implement the removal of
therapy thresholds for payment as required by section 1895(b)(4)(B)(ii)
of the Act, as amended by section 51001(a)(3) of the BBA of 2018, and
changes the unit of home health payment from 60-day episodes of care to
30-day periods of care, as required by section 1895(b)(2)(B) of the
Act, as amended by 51001(a)(1) of the BBA of 2018. This proposed rule
also proposes to allow therapist assistants to furnish maintenance
therapy; proposes changes to the payment regulations pertaining to the
content of the home health plan of care; proposes technical regulations
text changes clarifying the split-percentage payment approach for
newly-enrolled HHAs in CY 2020 and proposes a change in the split
percentage payment approach for existing HHAs in CY 2020 and subsequent
years.
2. HHVBP
    This rule proposes public reporting of the TPS and the TPS
Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and
Payment Adjustment Report for each HHA that qualifies for a payment
adjustment under the HHVBP Model for CY 2020.
3. HH QRP
    This rule purposes changes to the Home Health Quality Reporting
Program (HH QRP) requirements under the authority of section
1895(b)(3)(B)(v) of the Act.
4. Home Infusion Therapy
    This proposed rule would update the CY 2020 payment rates for the
temporary transitional payment for home infusion therapy services as
required by section 1834(u)(7) of the Act, as added by section 50401 of
the BBA of 2018. This rule also proposes payment provisions for home
infusion therapy services for CY 2021 and subsequent years in
accordance with section 1834(u)(1) of the Act, as added by section 5012
of the 21st Century Cures Act (Pub. L. 114-255).
B. Summary of the Major Provisions
1. Home Health Prospective Payment System (HH PPS)
    Section III.A. of this rule, sets forth planned implementation of
the Patient-Driven Groupings Model (PDGM) as required by section 51001
of the BBA of 2018 (Pub. L. 115-123). The PDGM is an alternate case-mix
adjustment methodology to adjust payments for home health periods of
care beginning on and after January 1, 2020. The PDGM relies more
heavily on clinical characteristics and other patient information to
place patients into meaningful payment categories and eliminates the
use of therapy service thresholds, as required by section 1895(b)(4)(B)
of the Act, as amended by section 51001(a)(3) of the BBA of 2018.
Section III.B. of this rule also implements a change in the unit of
payment from a 60-day episode of care to a 30-day period of care as
required by section 1895(b)(2) of the Act, as amended by section
51001(a)(1) of the BBA of 2018.
    Section III.C. of this proposed rule describes the CY 2020 case-mix
weights for those 60-day episodes that span the implementation date of
the PDGM and section III.D. of this proposed rule proposes the CY 2020
PDGM case-mix weights and LUPA thresholds for 30-day periods of care.
In section III.E. of this proposed rule, we propose to update the home
health wage index and to update the national, standardized 60-day
episode of care and 30-day period of care payment amounts, the national
per-visit payment amounts as well and the non-routine supplies (NRS)
conversion factor for 60-day episodes of care that begin in 2019 and
span the 2020 implementation date of the PDGM. The home health payment
update percentage for CY 2020 will be 1.5 percent, as required by
section 53110 of the BBA of 2018. We also solicit comments on concerns
stakeholders may have regarding the wage index used to adjust home
health payments and suggestions for possible updates and improvements
to the geographic adjustment of home health payments. Section III.F. of
this proposed rule proposes a change to the fixed-dollar loss ratio to
0.63 for CY 2020 under the PDGM in order to ensure that outlier
payments as a percentage of total payments is closer to, but no more
than, 2.5 percent, as required by section 1895(b)(5)(A) of the Act.
Section III.G. of this proposed rule, proposes a technical regulations
text correction at Sec.  484.205 regarding split-percentage payments
for newly-enrolled HHAs in CY 2020; proposes changes to reduce the
split-percentage payment amounts for existing HHAs in CY 2020; and
proposes to eliminate split-percentage payments entirely beginning in
CY 2021. In section III.H. of this proposed rule, we propose to allow
physical therapist assistants to furnish maintenance therapy under the
Medicare home health benefit, and section III.I. of this proposed
proposes a change in the payment regulations at
[[Page 34600]]
Sec.  409.43 related to home health plan of care requirements for
payment.
2. HHVBP
    In section IV. of this proposed rule, we are proposing to publicly
report performance data for Performance Year (PY) 5 of the HHVBP Model.
Specifically, we are proposing to publicly report the TPS and the TPS
Percentile Ranking from the PY 5 (CY 2020) Annual TPS and Payment
Adjustment Report for each HHA in the nine Model states that qualified
for a payment adjustment for CY 2020.
3. HH QRP
    In section V. of this rule, we propose updates to the Home Health
Quality Reporting Program (HH QRP) including: The removal of one
quality measure, the adoption of two new quality measures, the
modification of an existing measure, and the reporting of standardized
patient assessment data described under section 1899B(b)(1)(B) of the
Act. In section V.J. of this rule, we are proposing to codify HH QRP
policies in a newly created section of the regulations. Finally, in
section V.K. of the rule we propose removing question 10 from all
HHCAHPS Surveys (both mail surveys and telephone surveys).
4. Home Infusion Therapy
    In section VI.A. of this proposed rule, we discuss general
background of home infusion therapy services and how that will relate
to the implementation of the new home infusion benefit in CY 2021.
Section VI.B. of this proposed rule updates the CY 2020 home infusion
therapy services temporary transitional payment rates, in accordance
with section 1834(u)(7) of the Act. In section VI.C. of this proposed
rule, we are proposing to add a new subpart P under the regulations at
42 CFR part 414 to incorporate conforming regulations text regarding
conditions for payment for home infusion therapy services for CY 2021
and subsequent years. Proposed subpart P would include beneficiary
qualifications and plan of care requirements in accordance with section
1861(iii) of the Act. In section VI.D. of this proposed rule, we
propose payment provisions for the full implementation of the home
infusion therapy benefit in CY 2021 upon expiration of the home
infusion therapy services temporary transitional payments in CY 2020.
The home infusion therapy services payment system is to be implemented
starting in CY 2021, as mandated by section 5012 of the 21st Century
Cures Act. The provisions in this section include proposed payment
categories, amounts, and required and optional payment adjustments. In
section VI.E. of this proposed rule, we propose to use the Geographic
Adjustment Factor (GAF) to wage adjust the home infusion therapy
payment as required by section 1834(u)(1)(B)(i) of the Act. In this
section VI.F. of this proposed rule, we offer a discussion on several
topics for home infusion therapy services for CY 2021 such as: Optional
payment adjustments, prior authorization, and high-cost outliers.
Lastly, in section VI.H. of this proposed rule, we discuss billing
procedures for CY 2021 home infusion therapy services.
C. Summary of Costs, Transfers, and Benefits
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[[Page 34601]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.034
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II. Overview of the Home Health Prospective Payment System
A. Statutory Background
    The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted
August 5, 1997), significantly changed the way Medicare pays for
Medicare home health services. Section 4603 of the BBA mandated the
development of the HH PPS. Until the implementation of the HH PPS on
October 1, 2000, HHAs received payment under a retrospective
reimbursement system. Section 4603(a) of the BBA mandated the
development of a HH PPS for all Medicare-covered home health services
provided under a plan of care (POC) that were paid on a reasonable cost
basis by adding section 1895 of the Social Security Act (the Act),
entitled ``Prospective Payment For Home Health Services.'' Section
1895(b)(1) of the Act requires the Secretary to establish a HH PPS for
all costs of home health services paid under Medicare. Section
1895(b)(2) of the Act required that, in defining a prospective payment
amount, the Secretary will consider an appropriate unit of service and
the number, type, and duration of visits provided within that unit,
potential changes in the mix of services provided within that unit and
their cost, and a general system design that provides for continued
access to quality services.
    Section 1895(b)(3)(A) of the Act required the following: (1) The
computation of a standard prospective payment amount that includes all
costs for HH services covered and paid for on a reasonable cost basis,
and that such amounts be initially based on the most recent audited
cost report data available to the Secretary (as of the effective date
of the 2000 final rule), and (2) the standardized prospective payment
amount be adjusted to account for the effects of case-mix and wage
levels among HHAs.
    Section 1895(b)(3)(B) of the Act requires the standard prospective
payment amounts be annually updated by the home health applicable
percentage increase. Section 1895(b)(4) of the Act governs the payment
computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act
require the standard prospective payment amount to be adjusted for
case-mix and geographic differences in wage levels. Section
1895(b)(4)(B) of the Act requires
[[Page 34602]]
the establishment of an appropriate case-mix change adjustment factor
for significant variation in costs among different units of services.
    Similarly, section 1895(b)(4)(C) of the Act requires the
establishment of area wage adjustment factors that reflect the relative
level of wages, and wage-related costs applicable to home health
services furnished in a geographic area compared to the applicable
national average level. Under section 1895(b)(4)(C) of the Act, the
wage-adjustment factors used by the Secretary may be the factors used
under section 1886(d)(3)(E) of the Act. Section 1895(b)(5) of the Act
gives the Secretary the option to make additions or adjustments to the
payment amount otherwise paid in the case of outliers due to unusual
variations in the type or amount of medically necessary care. Section
3131(b)(2) of the Affordable Care Act revised section 1895(b)(5) of the
Act so that total outlier payments in a given year would not exceed 2.5
percent of total payments projected or estimated. The provision also
made permanent a 10 percent agency-level outlier payment cap.
    In accordance with the statute, as amended by the BBA, we published
a final rule in the July 3, 2000 Federal Register (65 FR 41128) to
implement the HH PPS legislation. The July 2000 final rule established
requirements for the new HH PPS for home health services as required by
section 4603 of the BBA, as subsequently amended by section 5101 of the
Omnibus Consolidated and Emergency Supplemental Appropriations Act for
Fiscal Year 1999 (OCESAA), (Pub. L. 105-277, enacted October 21, 1998);
and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP
Balanced Budget Refinement Act of 1999, (BBRA) (Pub. L. 106-113,
enacted November 29, 1999). The requirements include the implementation
of a HH PPS for home health services, consolidated billing
requirements, and a number of other related changes. The HH PPS
described in that rule replaced the retrospective reasonable cost-based
system that was used by Medicare for the payment of home health
services under Part A and Part B. For a complete and full description
of the HH PPS as required by the BBA, see the July 2000 HH PPS final
rule (65 FR 41128 through 41214).
    Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v)
to the Act, requiring HHAs to submit data for purposes of measuring
health care quality, and linking the quality data submission to the
annual applicable payment percentage increase. This data submission
requirement is applicable for CY 2007 and each subsequent year. If an
HHA does not submit quality data, the home health market basket
percentage increase is reduced by 2 percentage points. In the November
9, 2006 Federal Register (71 FR 65935), we published a final rule to
implement the pay-for-reporting requirement of the DRA, which was
codified at Sec.  484.225(h) and (i) in accordance with the statute.
The pay-for-reporting requirement was implemented on January 1, 2007.
    The Affordable Care Act made additional changes to the HH PPS. One
of the changes in section 3131 of the Affordable Care Act is the
amendment to section 421(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173,
enacted on December 8, 2003) as amended by section 5201(b) of the DRA.
Section 421(a) of the MMA, as amended by section 3131 of the Affordable
Care Act, requires that the Secretary increase, by 3 percent, the
payment amount otherwise made under section 1895 of the Act, for HH
services furnished in a rural area (as defined in section 1886(d)(2)(D)
of the Act) with respect to episodes and visits ending on or after
April 1, 2010, and before January 1, 2016.
    Section 210 of the Medicare Access and CHIP Reauthorization Act of
2015 (Pub. L. 114-10) (MACRA) amended section 421(a) of the MMA to
extend the 3 percent rural add-on payment for home health services
provided in a rural area (as defined in section 1886(d)(2)(D) of the
Act) through January 1, 2018. In addition, section 411(d) of MACRA
amended section 1895(b)(3)(B) of the Act such that CY 2018 home health
payments be updated by a 1 percent market basket increase. Section
50208(a)(1) of the BBA of 2018 again extended the 3 percent rural add-
on through the end of 2018. In addition, this section of the BBA of
2018 made some important changes to the rural add-on for CYs 2019
through 2022, to be discussed later in this proposed rule.
B. Current System for Payment of Home Health Services
    Generally, Medicare currently makes payment under the HH PPS on the
basis of a national, standardized 60-day episode payment rate that is
adjusted for the applicable case-mix and wage index. The national,
standardized 60-day episode rate includes the six home health
disciplines (skilled nursing, home health aide, physical therapy,
speech-language pathology, occupational therapy, and medical social
services). Payment for non-routine supplies (NRS) is not part of the
national, standardized 60-day episode rate, but is computed by
multiplying the relative weight for a particular NRS severity level by
the NRS conversion factor. Payment for durable medical equipment
covered under the HH benefit is made outside the HH PPS payment system.
To adjust for case-mix, the HH PPS uses a 153-category case-mix
classification system to assign patients to a home health resource
group (HHRG). The clinical severity level, functional severity level,
and service utilization are computed from responses to selected data
elements in the Outcome and Assessment Information Set (OASIS)
assessment instrument and are used to place the patient in a particular
HHRG. Each HHRG has an associated case-mix weight which is used in
calculating the payment for an episode. Therapy service use is measured
by the number of therapy visits provided during the episode and can be
categorized into nine visit level categories (or thresholds): 0 to 5;
6; 7 to 9; 10; 11 to 13; 14 to 15; 16 to 17; 18 to 19; and 20 or more
visits.
    For episodes with four or fewer visits, Medicare pays national per-
visit rates based on the discipline(s) providing the services. An
episode consisting of four or fewer visits within a 60-day period
receives what is referred to as a low-utilization payment adjustment
(LUPA). Medicare also adjusts the national standardized 60-day episode
payment rate for certain intervening events that are subject to a
partial episode payment adjustment (PEP adjustment). For certain cases
that exceed a specific cost threshold, an outlier adjustment may also
be available.
C. New Home Health Prospective Payment System for CY 2020 and
Subsequent Years
    In the CY 2019 HH PPS final rule (83 FR 56446), we finalized a new
patient case-mix adjustment methodology, the Patient-Driven Groupings
Model (PDGM), to shift the focus from volume of services to a more
patient-driven model that relies on patient characteristics. For home
health periods of care beginning on or after January 1, 2020, the PDGM
uses timing, admission source, principal and other diagnoses, and
functional impairment to case-mix adjust payments. The PDGM results in
432 unique case-mix groups. Low-utilization payment adjustments (LUPAs)
will vary; instead of the current four visit threshold, each of the 432
case-mix groups has its own threshold to determine if a 30-day period
of care
[[Page 34603]]
would receive a LUPA. Additionally, non-routine supplies (NRS) are
included in the base payment rate for the PDGM instead of being
separately adjusted as in the current HH PPS. Also in the CY 2019 HH
PPS final rule, we finalized a change in the unit of home health
payment from 60-day episodes of care to 30-day periods of care, and
eliminated the use of therapy thresholds used to adjust payments in
accordance with section 51001 of the BBA of 2018. Thirty-day periods of
care will be adjusted for outliers and partial episodes as applicable.
For LUPAs under the PDGM, we finalized that the LUPA threshold would
vary for a 30-day period under the PDGM using 10th percentile value of
visits to create a payment group specific LUPA threshold with a minimum
threshold of at least 2 visits for each payment group. Finally, for CYs
2020 through 2022, home health services provided to beneficiaries
residing in rural counties will be increased based on rural county
classification (high utilization; low population density; or all
others) in accordance with section 50208 of the BBA of 2018.
D. Analysis of FY 2017 HHA Cost Report Data for 60-Day Episodes and 30-
Day Periods
    In the CY 2019 HH PPS proposed rule (83 FR 32348), we provided a
summary of analysis on fiscal year (FY) 2016 HHA cost report data and
how such data, if used, would impact our estimate of the percentage
difference between Medicare payments and HHA costs. We stated in the CY
2019 HH PPS final rule (83 FR 56414) that we will continue to monitor
the impacts due to policy changes and will provide the industry with
periodic updates on our analysis in rulemaking and/or announcements on
the HHA Center web page.
    In this year's proposed rule, we examined FY 2017 HHA cost reports
as this is the most recent and complete cost report data at the time of
rulemaking. We examined the estimated 60-day episode costs using FY
2017 cost reports and CY 2017 home health claims and the estimated
costs for 60-day episodes by discipline and the total estimated cost
for a 60-day episode for 2017 is shown in Table 2.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP18JY19.035
    To estimate the costs for CY 2020, we updated the estimated 60-day
episode costs with NRS by the home health market basket update, minus
the multifactor productivity adjustment for CYs 2018 and 2019. For CY
2020, the BBA of 2018 requires a market basket update of 1.5 percent.
The estimated costs for 60-day episodes by discipline and the total
estimated cost for a 60-day episode for CY 2020 is shown in Table 3.
[GRAPHIC] [TIFF OMITTED] TP18JY19.036
    The CY 2019 60-day episode payment is $3,154.27. Updating this
payment amount by the CY 2020 home health market basket of 1.5 percent
results in an estimated CY 2020 60-day episode payment of $3,201.58,
approximately 18
[[Page 34604]]
percent more than the estimated CY 2020 60-day episode cost of
$2,713.30. Next, we also looked at the estimated costs for 30-day
periods of care in 2017 using FY 2017 cost reports and CY 2017 claims.
Thirty-day periods were simulated from 60-day episodes and we excluded
low-utilization payment adjusted episodes and partial-episode-payment
adjusted episodes. The 30-day periods were linked to OASIS assessments
and covered the 60-day episodes ending in CY 2017. The estimated costs
for 30-day periods by discipline and the total estimated cost for a 30-
day period for 2017 is shown in Table 4.
[GRAPHIC] [TIFF OMITTED] TP18JY19.037
    To estimate the costs for CY 2020, we updated the estimated 30-day
period costs with NRS by the home health market basket update, minus
the multifactor productivity adjustment for CYs 2018 and 2019. For CY
2020, the BBA of 2018 requires a market basket update of 1.5 percent.
The estimated costs for 30-day periods by discipline and the total
estimated cost for a 30-day period for CY 2020 is shown in Table 5.
[GRAPHIC] [TIFF OMITTED] TP18JY19.038
BILLING CODE 4120-01-C
    The estimated, budget-neutral 30-day payment for CY 2020 is
$1,754.37 as described in section III.E. of this proposed rule.
Updating this amount by the CY 2020 home health market basket of 1.5
percent and the wage index budget neutrality factor results in an
estimated CY 2020 30-day payment amount of $ $1,791.73, approximately
14 percent more than the estimated CY 2020 30-day period cost of
$1,577.52. After implementation of the 30-day unit of payment and the
PDGM in CY 2020, we will continue to analyze the costs by discipline as
well as the overall cost for a 30-day period of care to determine the
effects, if any, of these changes.
III. Proposed Provisions for Payment Under the Home Health Prospective
Payment System (HH PPS)
A. Implementation of the Patient-Driven Groupings Model (PDGM) for CY
2020
1. Background and Legislative History
    In the CY 2019 HH PPS final rule (83 FR 56406), we finalized
provisions to implement changes mandated by the BBA of 2018 for CY
2020, which included a change in the unit of payment from a 60-day
episode of care to a 30-day period of care, as required by section
51001(a)(1)(B), and the elimination of therapy thresholds used for
adjusting home health payment, as required by section 51001(a)(3)(B).
In order to eliminate the use of therapy thresholds in adjusting
payment under the HH PPS, we finalized an alternative case mix-
adjustment methodology, known as the Patient-Driven Groupings Model
(PDGM), to be implemented for home health periods of care beginning on
or after January 1, 2020.
[[Page 34605]]
    In regard to the 30-day unit of payment, section 51001(a)(1) of the
BBA of 2018 amended section 1895(b)(2) of the Act by adding a new
subparagraph (B) to require the Secretary to apply a 30-day unit of
service, effective January 1, 2020. Section 51001(a)(2)(A) of the BBA
of 2018 added a new subclause (iv) under section 1895(b)(3)(A) of the
Act, requiring the Secretary to calculate a standard prospective
payment amount (or amounts) for 30-day units of service furnished that
start and end during the 12-month period beginning January 1, 2020 in a
budget neutral manner such that estimated aggregate expenditures under
the HH PPS during CY 2020 are equal to the estimated aggregate
expenditures that otherwise would have been made under the HH PPS
during CY 2020 in the absence of the change to a 30-day unit of
service. Section 1895(b)(3)(A)(iv) of the Act requires that the
calculation of the standard prospective payment amount (or amounts) for
CY 2020 be made before the application of the annual update to the
standard prospective payment amount as required by section
1895(b)(3)(B) of the Act.
    Section 1895(b)(3)(A)(iv) of the Act additionally requires that in
calculating the standard prospective payment amount (or amounts), the
Secretary must make assumptions about behavior changes that could occur
as a result of the implementation of the 30-day unit of service under
section 1895(b)(2)(B) of the Act and case-mix adjustment factors
established under section 1895(b)(4)(B) of the Act. Section
1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide
a description of the behavior assumptions made in notice and comment
rulemaking. CMS described these behavior assumptions in the CY 2019 HH
PPS proposed rule (83 FR 32389) and these assumptions are further
described in section III.F. of this proposed rule.
    Section 51001(a)(2)(B) of the BBA of 2018 also added a new
subparagraph (D) to section 1895(b)(3) of the Act. Section
1895(b)(3)(D)(i) of the Act requires the Secretary to annually
determine the impact of differences between assumed behavior changes as
described in section 1895(b)(3)(A)(iv) of the Act, and actual behavior
changes on estimated aggregate expenditures under the HH PPS with
respect to years beginning with 2020 and ending with 2026. Section
1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a
manner determined appropriate, through notice and comment rulemaking,
to provide for one or more permanent increases or decreases to the
standard prospective payment amount (or amounts) for applicable years,
on a prospective basis, to offset for such increases or decreases in
estimated aggregate expenditures, as determined under section
1895(b)(3)(D)(i) of the Act. Additionally, 1895(b)(3)(D)(iii) of the
Act requires the Secretary, at a time and in a manner determined
appropriate, through notice and comment rulemaking, to provide for one
or more temporary increases or decreases, based on retrospective
behavior, to the payment amount for a unit of home health services for
applicable years, on a prospective basis, to offset for such increases
or decreases in estimated aggregate expenditures, as determined under
section 1895(b)(3)(D)(i) of the Act. Such a temporary increase or
decrease shall apply only with respect to the year for which such
temporary increase or decrease is made, and the Secretary shall not
take into account such a temporary increase or decrease in computing
the payment amount for a unit of home health services for a subsequent
year. And finally, section 51001(a)(3) of the BBA of 2018 amends
section 1895(b)(4)(B) of the Act by adding a new clause (ii) to require
the Secretary to eliminate the use of therapy thresholds in the case-
mix system for CY 2020 and subsequent years.
2. Overview and CY 2020 Implementation of the PDGM
    To better align payment with patient care needs and better ensure
that clinically complex and ill beneficiaries have adequate access to
home health care, in the CY 2019 HH PPS final rule (83 FR 56406), we
finalized case-mix methodology refinements through the PDGM for home
health periods of care beginning on or after January 1, 2020. We
believe that the PDGM case-mix methodology better aligns payment with
patient care needs and is a patient-centered model that groups periods
of care in a manner consistent with how clinicians differentiate
between patients and the primary reason for needing home health care.
This proposed rule would set forth the requirements for the
implementation of the PDGM, as well as updates to the PDGM case-mix
weights and payment rates, which would be effective on January 1, 2020.
The PDGM and a change to a 30-day unit of payment were finalized in the
CY 2019 HH PPS final rule (83 FR 56406) and, as such, there are no new
policy proposals in this proposed rule on the structure of the PDGM or
the change to a 30-day unit of payment. However, there are proposals
related to the split-percentage payments upon implementation of the
PDGM and the 30-day unit of payment in section III.G. of this proposed
rule.
    The PDGM uses 30-day periods of care rather than 60-day episodes of
care as the unit of payment, as required by section 51001(a)(1)(B) of
the BBA of 2018; eliminates the use of the number of therapy visits
provided to determine payment, as required by section 51001(a)(3)(B) of
the BBA of 2018; and relies more heavily on clinical characteristics
and other patient information (for example, diagnosis, functional
level, comorbid conditions, admission source) to place patients into
clinically meaningful payment categories. A national, standardized 30-
day period payment amount, as described in section III.F. of this
proposed rule, would be adjusted by the case-mix weights as determined
by the variables in the PDGM. Payment for non-routine supplies (NRS) is
now included in the national, standardized 30-day payment amount. In
total, there are 432 different payment groups in the PDGM. These 432
Home Health Resource Groups (HHRGs) represent the different payment
groups based on five main case-mix variables under the PDGM, as shown
in Diagram B1, and subsequently described in more detail throughout
this section.
    Under this new case-mix methodology, case-mix weights are generated
for each of the different PDGM payment groups by regressing resource
use for each of the five categories listed in this section of this
proposed rule (timing, admission source, clinical grouping, functional
impairment level, and comorbidity adjustment) using a fixed effects
model. Annually recalibrating the PDGM case-mix weights ensures that
the case-mix weights reflect the most recent utilization data at the
time of annual rulemaking. The proposed CY 2020 PDGM case-mix weights
are listed in section III.D. of this proposed rule.
BILLING CODE 4120-01-P
[[Page 34606]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.039
BILLING CODE 4120-01-C
a. Timing
    Under the PDGM, 30-day periods of care will be classified as
``early'' or ``late'' depending on when they occur within a sequence of
30-day periods. Under the PDGM, the first 30-day period of care will be
classified as early and all subsequent 30-day periods of care in the
sequence (second or later) will be classified as late. A 30-day period
will not be considered early unless there is a gap of more than 60 days
between the end of one period of care and the start of another.
Information regarding the timing of a 30-day period of care will come
from Medicare home health claims data and not the OASIS assessment to
determine if a 30-day period of care is ``early'' or ``late''. While
the PDGM case-mix adjustment is applied to each 30-day period of care,
other home health requirements will continue on a 60-day basis.
Specifically, certifications and recertifications continue on a 60-day
basis and the comprehensive assessment will still be completed within 5
days of the start of care date and completed no less frequently than
during the last 5 days of every 60 days beginning with the start of
care date, as currently required by Sec.  484.55, ``Condition of
participation: Comprehensive assessment of patients.''
b. Admission Source
    Each 30-day period of care will also be classified into one of two
admission source categories--community or institutional--depending on
what healthcare setting was utilized in the 14 days prior to home
health. Thirty-day periods of care for beneficiaries with any inpatient
acute care hospitalizations, inpatient psychiatric facility (IPF)
stays, skilled nursing facility (SNF) stays, inpatient rehabilitation
facility (IRF) stays, or long-term care hospital (LTCH) stays within
14-days prior to a home health admission will be designated as
institutional admissions.
[[Page 34607]]
    The institutional admission source category will also include
patients that had an acute care hospital stay during a previous 30-day
period of care and within 14 days prior to the subsequent, contiguous
30-day period of care and for which the patient was not discharged from
home health and readmitted (that is, the ``admission date'' and ``from
date'' for the subsequent 30-day period of care do not match), as we
acknowledge that HHAs have discretion as to whether they discharge the
patient due to a hospitalization and then readmit the patient after
hospital discharge. However, we will not categorize post-acute care
stays, meaning SNF, IRF, LTCH, or IPF stays, that occur during a
previous 30-day period of care and within 14 days of a subsequent,
contiguous 30-day period of care as institutional (that is, the
``admission date'' and ``from date'' for the subsequent 30-day period
of care do not match), as we would expect the HHA to discharge the
patient if the patient required post-acute care in a different setting,
or inpatient psychiatric care, and then readmit the patient, if
necessary, after discharge from such setting. All other 30-day periods
of care would be designated as community admissions.
    Information from the Medicare claims processing system will
determine the appropriate admission source for final claim payment. The
OASIS assessment will not be utilized in evaluating for admission
source information. We believe that obtaining this information from the
Medicare claims processing system, rather than as reported on the
OASIS, is a more accurate way to determine admission source information
as HHAs may be unaware of an acute or post-acute care stay prior to
home health admission. While HHAs can report an occurrence code on
submitted claims to indicate the admission source, obtaining this
information from the Medicare claims processing system allows CMS the
opportunity and flexibility to verify the source of the admission and
correct any improper payments as deemed appropriate. When the Medicare
claims processing system receives a Medicare home health claim, the
systems will check for the presence of a Medicare acute or post-acute
care claim for an institutional stay. If such an institutional claim is
found, and the institutional claim occurred within 14 days of the home
health admission, our systems will trigger an automatic adjustment to
the corresponding HH claim to the appropriate institutional category.
Similarly, when the Medicare claims processing system receives a
Medicare acute or post-acute care claim for an institutional stay, the
systems will check for the presence of a HH claim with a community
admission source payment group. If such HH claim is found, and the
institutional stay occurred within 14 days prior to the home health
admission, our systems will trigger an automatic adjustment of the HH
claim to the appropriate institutional category. This process may occur
any time within the 12-month timely filing period for the acute or
post-acute claim.
    However, situations in which the HHA has information about the
acute or post-acute care stay, HHAs will be allowed to manually
indicate on Medicare home health claims that an institutional admission
source had occurred prior to the processing of an acute/post-acute
Medicare claim, in order to receive higher payment associated with the
institutional admission source. This will be done through the reporting
of one of two admission source occurrence codes on home health claims--
     Occurrence Code 61: To indicate an acute care hospital
discharge within 14 days prior to the ``From Date'' of any home health
claim; or
     Occurrence Code 62: To indicate a SNF, IRF, LTCH, or IPF
discharge with 14 days prior to the ``Admission Date'' of the first
home health claim.
    If the HHA does not include an occurrence code on the HH claim to
indicate that that the home health patient had a previous acute or
post-acute care stay, the period of care will be categorized as a
community admission source. However, if later a Medicare acute or post-
acute care claim for an institutional stay occurring within 14 days of
the home health admission is submitted within the timely filing
deadline and processed by the Medicare systems, the HH claim will be
automatically adjusted as an institutional admission and the
appropriate payment modifications will be made. For purposes of a
Request for Anticipated Payment (RAP), only the final claim will be
adjusted to reflect the admission source. More information regarding
the admission source reporting requirements for RAP and claims
submission can be found in Change Request 11081, ``Home Health (HH)
Patient-Drive Groupings Model (PDGM)-Split Implementation''.\1\
Accordingly, the Medicare Claims Processing Manual, chapter 10,\2\ will
be updated to reflect all of the claims processing changes associated
with implementation of the PDGM.
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    \1\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4244CP.pdf.
    \2\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c10.pdf.
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c. Clinical Groupings
    Each 30-day period of care will be grouped into one of 12 clinical
groups which describe the primary reason for which patients are
receiving home health services under the Medicare home health benefit.
The clinical grouping is based on the principal diagnosis reported on
home health claims. The 12 clinical groups are listed and described in
Table 6.
[[Page 34608]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.040
    It is possible for the principal diagnosis to change between the
first and second 30-day period of care and the claim for the second 30-
day period of care would reflect the new principal diagnosis. HHAs
would not change the claim for the first 30-day period. However, a
change in the principal diagnosis does not necessarily mean that an
``other follow-up'' OASIS assessment (RFA 05) would need to be
completed just to make the diagnoses match. However, if a patient
experienced a significant change in condition before the start of a
subsequent, contiguous 30-day period of care, for example due to a
fall, in accordance with Sec.  484.55(d)(1)(ii) the HHA is required to
update the comprehensive assessment. The Home Health Agency
Interpretive Guidelines for Sec.  484.55(d), state that a marked
improvement or worsening of a patient's condition, which changes, and
was not anticipated in, the patient's plan of care would be considered
a ``major decline or improvement in the patient's health status'' that
would warrant update and revision of the comprehensive assessment.\3\
Additionally, in accordance with Sec.  484.60, the total plan of care
must be reviewed and revised by the physician who is responsible for
the home health plan of care and the HHA as frequently as the patient's
condition or needs require, but no less frequently than once every 60
days, beginning with the start of care date.
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    \3\ State Operations Manual (SOM), Appendix B. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-25-HHA.pdf.
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    In the event of a significant change of condition warranting an
updated comprehensive assessment, an ``other follow-up assessment''
(RFA 05) would be submitted before the start of a subsequent,
contiguous 30-day period, which may reflect a change in the functional
impairment level and the second 30-day claim would be grouped into its
appropriate case-mix group accordingly. An ``other follow-up
assessment'' is a comprehensive assessment conducted due to a major
decline or improvement in patient's health status occurring at a time
other than during the last 5 days of the episode. This assessment is
done to re-evaluate the patient's condition, allowing revision to the
patient's care plan as appropriate. The ``Outcome and Assessment
Information Set OASIS-D Guidance Manual,'' effective January 1, 2019,
provides more detailed guidance for the completion of an ``other
follow-up'' assessment.\4\ In this respect, two 30-day periods can have
two different case-mix groups to reflect any changes in patient
condition. HHAs must be sure to update the assessment completion date
on the second 30-day claim if a follow-up assessment changes the case-
mix group to ensure the claim can be matched to the follow-up
assessment. HHAs can submit an adjustment to the original claim
submitted if an assessment was completed before the start of the second
30-day period, but was received after the claim was submitted and if
the assessment items would change the payment grouping.
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    \4\ Outcome and Assessment Information Set OASIS-D Guidance
Manual Effective January 1, 2019 available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-D-Guidance-Manual-final.pdf.
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    HHAs would determine whether or not to complete a follow-up OASIS
assessment for a second 30-day period of care depending on the
individual's clinical circumstances. For example, if the only change
from the first 30-day period and the second 30-day period is a change
to the principal diagnosis and there is no change in the patient's
function, the HHA may determine it is not necessary to complete a
follow-up assessment. Therefore, the expectation is that HHAs would
determine whether an ``other follow-up'' assessment is required based
on the individual's overall condition, the effects of the change on the
overall home health plan of care, and in accordance with the home
health CoPs, interpretive guidelines, and the OASIS D Guidance Manual
instructions, as previously noted.
    For case-mix adjustment purposes, the principal diagnosis reported
on the home health claim will determine the clinical group for each 30-
day period of care. Currently, billing instructions state that the
principal diagnosis on the OASIS must also be the principal diagnosis
on the final claim; however, we will update our billing instructions to
clarify that there will be no need for the HHA to complete an ``other
follow-up'' assessment (an RFA 05) just to make the diagnoses match.
Therefore, for claim ``From'' dates on or after January 1, 2020, the
ICD-10-CM code and principal diagnosis used for payment grouping will
be from the claim rather than the OASIS. As a result, the claim and
OASIS diagnosis codes will no longer be expected to match in all cases.
Additional claims processing guidance, including the role of the OASIS
item set will be included
[[Page 34609]]
in the Medicare Claims Processing Manual, chapter 10.\5\
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    \5\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c10.pdf.
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    While these clinical groups represent the primary reason for home
health services during a 30-day period of care, this does not mean that
they represent the only reason for home health services. While there
are clinical groups where the primary reason for home health services
is for therapy (for example, Musculoskeletal Rehabilitation) and other
clinical groups where the primary reason for home health services is
for nursing (for example, Complex Nursing Interventions), home health
remains a multidisciplinary benefit and payment is bundled to cover all
necessary home health services identified on the individualized home
health plan of care. Therefore, regardless of the clinical group
assignment, HHAs are required, in accordance with the home health CoPs
at Sec.  484.60(a)(2), to ensure that the individualized home health
plan of care addresses all care needs, including the disciplines to
provide such care. Under the PDGM, the clinical group is just one
variable in the overall case-mix adjustment for a home health period of
care.
    Finally, we note that we will update the Interactive Grouper Tool
posted on both the HHA Center web page (https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html) and the dedicated
PDGM web page (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html). This Interactive Grouper Tool will
include all of the ICD-10 diagnosis codes used in the PDGM and may be
used by HHAs to generate PDGM case-mix weights for their patient
census. This tool is for informational and illustrative purposes only.
HHAs can also request a Home Health Claims-OASIS Limited Data Set (LDS)
to accompany the CY 2020 HH PPS proposed and final rules to support
HHAs in evaluating the effects of the PDGM. The Home Health Claims-
OASIS LDS file can be requested by following the instructions on the
following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html.
d. Functional Impairment Level
    Under the PDGM, each 30-day period of care will be placed into one
of three functional impairment levels, low, medium, or high, based on
responses to certain OASIS functional items as listed in Table 7.
[GRAPHIC] [TIFF OMITTED] TP18JY19.041
    Responses to these OASIS items are grouped together into response
categories with similar resource use and each response category has
associated points. A more detailed description as to how these response
categories were established can be found in the technical report,
``Overview of the Home Health Groupings Model'' posted on the Home
Health Center web page.\6\ The sum of these points' results in a
functional impairment level score used to group 30-day periods of care
into a functional impairment level with similar resource use. The
scores associated with the functional impairment levels vary by
clinical group to account for differences in resource utilization. For
CY 2020, we used CY 2018 claims data to update the functional points
and functional impairment levels by clinical group. The updated OASIS
functional points table and the table of functional impairment levels
by clinical group for CY 2020 are listed in Tables 4 and 5,
respectively. For ease of use, instead of listing the response
categories and the associated points (as shown in Table 28 in the CY
2019 HH PPS final rule, 83 FR 56478), we have reformatted the OASIS
Functional Item Response Points (Table 8) to identify how the OASIS
functional items used for the functional impairment level are assigned
points under the PDGM. In the CY 2020 HH PPS final rule, we will update
the points for the OASIS functional item response categories and the
functional impairment levels by clinical group using the most recent,
available claims data.
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    \6\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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BILLING CODE 4120-01-C
[[Page 34610]]
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[GRAPHIC] [TIFF OMITTED] TP18JY19.043
[[Page 34611]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.044
BILLING CODE 4120-01-P
    The functional impairment level will remain the same for the first
and second 30-day periods of care unless there has been a significant
change in condition which warranted an ``other follow-up'' assessment
prior to the second 30-day period of care. For each 30-day period of
care, the Medicare claims processing system will look for the most
recent OASIS assessment based on the claims ``from date.'' The proposed
CY 2020 functional points table and the functional impairment level
thresholds table will be posted on the HHA Center web page at https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html as
well as on the dedicated PDGM web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html.
e. Comorbidity Adjustment
    Thirty-day periods will receive a comorbidity adjustment category
based on the presence of certain secondary diagnoses reported on home
health claims. These diagnoses are based on a home-health specific list
of clinically and statistically significant secondary diagnosis
subgroups with similar resource use, meaning the diagnoses have at
least as high as the median resource use and represent more that 0.1
percent of 30-day periods of care. Home health 30-day periods of care
can receive a comorbidity adjustment under the following circumstances:
     Low comorbidity adjustment: There is a reported
secondary diagnosis on the home health-specific comorbidity subgroup
list that is associated with higher resource use.
     High comorbidity adjustment: There are two or
more secondary diagnoses on the home health-specific comorbidity
subgroup interaction list that are associated with higher resource use
when both are reported together compared to if they were reported
separately. That is, the two diagnoses may interact with one another,
resulting in higher resource use.
     No comorbidity adjustment: A 30-day period of
care will receive no comorbidity adjustment if no secondary diagnoses
exist or none meet the criteria for a low or high comorbidity
adjustment.
    In CY 2020, there are 12 low comorbidity adjustment subgroups as
identified in Table 10 and 34 high comorbidity adjustment interaction
subgroups as identified in Table 11. In the CY 2020 HH PPS final rule,
we will update the comorbidity subgroups and interaction subgroups
using the most recent, available claims data.
BILLING CODE 4120-01-C
[[Page 34612]]
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[[Page 34613]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.046
BILLING CODE 4120-01-C
    A 30-day period of care can have a low comorbidity adjustment or a
high comorbidity adjustment, but not both. A 30-day period of care can
receive only
[[Page 34614]]
one low comorbidity adjustment regardless of the number of secondary
diagnoses reported on the home health claim that fell into one of the
individual comorbidity subgroups or one high comorbidity adjustment
regardless of the number of comorbidity group interactions, as
applicable. The low comorbidity adjustment amount will be the same
across the subgroups and the high comorbidity adjustment will be the
same across the subgroup interactions. The proposed CY 2020 low
comorbidity adjustment subgroups and the high comorbidity adjustment
interaction subgroups including those diagnoses within each of these
comorbidity adjustments will be posted on the HHA Center webpage at
https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html as well as on the dedicated PDGM web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html.
B. Implementation of a 30-Day Unit of Payment for CY 2020
    Under section 1895(b)(3)(A)(iv) of the Act, we are required to
calculate a 30-day payment amount for CY 2020 in a budget-neutral
manner such that estimated aggregate expenditures under the HH PPS
during CY 2020 are equal to the estimated aggregate expenditures that
otherwise would have been made under the HH PPS during CY 2020 in the
absence of the change to a 30-day unit of payment. Section
1895(b)(3)(A)(iv) of the Act also requires that in calculating a 30-day
payment amount in a budget-neutral manner to the Secretary must make
assumptions about behavior changes that could occur as a result of the
implementation of the 30-day unit of payment. In addition, in
calculating a 30-day payment amount in a budget-neutral manner, we must
take into account behavior changes that could occur as a result of the
case-mix adjustment factors that are implemented in CY 2020. We are
also required to calculate a budget-neutral 30-day payment amount
before the provisions of section 1895(b)(3)(B) of the Act are applied;
that is, before the home health applicable percentage increase, the
adjustment if quality data are not reported, and the productivity
adjustment.
    In the CY 2019 HH PPS proposed rule (83 FR 32389), we proposed
three assumptions about behavior change that could occur in CY 2020 as
a result of the implementation of the 30-day unit of payment and the
implementation of the PDGM case-mix adjustment methodology:
     Clinical Group Coding: A key component of determining
payment under the PDGM is the 30-day period of care's clinical group
assignment, which is based on the principal diagnosis code for the
patient as reported by the HHA on the home health claim. Therefore, we
proposed to assume that HHAs will change their documentation and coding
practices and would put the highest paying diagnosis code as the
principal diagnosis code in order to have a 30-day period of care be
placed into a higher-paying clinical group. While we do not support or
condone coding practices or the provision of services solely to
maximize payment, we often take into account in proposed rules the
potential behavior effects of policy changes should they be finalized
and implemented.
     Comorbidity Coding: The PDGM further adjusts payments
based on patients' secondary diagnoses as reported by the HHA on the
home health claim. While the OASIS only allows HHAs to designate 1
primary diagnosis and 5 secondary diagnoses, the home health claim
allows HHAs to designate 1 principal diagnosis and 24 secondary
diagnoses. Therefore, we proposed to assume that by taking into account
additional ICD-10-CM diagnosis codes listed on the home health claim
(that exceed the 6 allowed on the OASIS), more 30-day periods of care
will receive a comorbidity adjustment than periods otherwise would have
received if we only used the OASIS diagnosis codes for payment. The
comorbidity adjustment in the PDGM can increase payment by up to 20
percent.
     LUPA Threshold: Rather than being paid the per-visit
amounts for a 30-day period of care subject to the low-utilization
payment adjustment (LUPA) under the proposed PDGM, we proposed to
assume that for one-third of LUPAs that are 1 to 2 visits away from the
LUPA threshold, HHAs will provide 1 to 2 extra visits to receive a full
30-day payment.\7\ LUPAs are paid when there are a low number of visits
furnished in a 30-day period of care. Under the PDGM, the LUPA
threshold ranges from 2-6 visits depending on the case-mix group
assignment for a particular period of care (see section III.D. of this
proposed rule for the LUPA thresholds that correspond to the 432 case-
mix groups under the PDGM).
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    \7\ Current data suggest that what would be about \1/3\ of the
LUPA episodes with visits near the LUPA threshold move up to become
non-LUPA episodes. We assume this experience will continue under the
PDGM, with about \1/3\ of those episodes 1 or 2 visits below the
thresholds moving up to become non-LUPA episodes.
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    While some commenters supported these three behavior assumptions in
calculating the budget-neutral 30-day payment amount, many commenters
disagreed with these assumptions stating that they seem arbitrary,
overly complex, and that they lack any foundation in evidence-based
data. Other commenters expressed concern that the behavior assumptions
would result in too high of a payment reduction and that this could
create potential access issues. However, in the CY 2019 HH PPS final
rule, we explained why we believe the three behavior assumptions are
appropriate based on previously obtained data and precedent for
adjusting home health prospective payments based on assumed behavior
changes. We believe that our examples and past experiences described in
more detail in the CY 2019 HH PPS final rule (83 FR 56456) demonstrate
that there is a substantive connection between the data and the
behavior assumptions made. Furthermore, the Medicare Payment Advisory
Commission (MedPAC) provided comments on the CY 2019 HH PPS proposed
rule and expressed their support for the behavior assumptions, stating
that past experience with the home health PPS demonstrates that HHAs
have changed coding, utilization, and the mix of services provided in
reaction to new payment incentives. Similarly, in its March, 2019
Report to Congress, MedPAC stated that behavior assumptions are
necessary to offset the spending increase expected in 2020 resulting
from the behavior changes.\8\
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    \8\ MedPAC Report to Congress, Home Care Services, chapter 9,
March, 2019. http://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch9_sec.pdf?sfvrsn=0.
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    With regards to our assumption that HHAs would code the highest-
paying diagnosis code as primary for the clinical grouping assignment,
this assumption is based on decades of past experience under the case-
mix system for the HH PPS and other case-mix systems. For example, we
summarized previous data regarding the substantial increase in payments
when transitioning from the diagnosis-related groups (DRGs) to the
Medicare Severity (MS)-DRGs that were not related to actual changes in
patient severity. Subsequent analysis of inpatient hospital claims data
supported prospective payment adjustments to account for documentation
and coding effects was detailed in both the FY 2010 and FY 2011 IPPS
final rules (74 FR 43770 and 75 FR 50356). We also noted
[[Page 34615]]
that in the first year of the Inpatient Rehabilitation Facility (IRF)
PPS, there were instances where case-mix increases resulted from
documentation and coding-induced changes (72 FR 47181). Similarly, we
cited multiple instances where CMS analyzed the 2008 case-mix
methodology refinements that resulted in the 153-group HH PPS case-mix
model to measure change in case-mix, both real and nominal (74 FR 40958
and 75 FR 43238). We stated that our analysis subsequent to these
refinements to the current case-mix methodology show an average of
approximately 2 percent nominal case-mix growth per year (82 FR 35274).
    For the comorbidity coding assumption, we stated that using the
home health claim for the comorbidity adjustment as opposed to the
OASIS provides more opportunity to report all comorbid conditions that
may affect the plan of care. The OASIS item set only allows HHAs to
report up to five secondary diagnoses, while the home health claim
(837I institutional claim format-electronic version of the UB-04)
allows HHAs to report up to 24 secondary diagnoses. Furthermore, ICD-10
coding guidelines require reporting of all secondary (additional)
diagnoses that affect the plan of care. Because the comorbidity
adjustment can increase payment by up to 20 percent, it is a reasonable
assumption that HHAs would encourage the accurate reporting of
secondary diagnoses affecting the home health plan of care to more
accurately identify the conditions affecting resource use.
    Finally, regarding the LUPA threshold assumption, in the CY 2019 HH
PPS final rule, we referenced data from the FY 2001 HH PPS final rule
where the episode file showed that approximately 16 percent of episodes
would have received a LUPA (meaning the 60-day episode had 4 or fewer
visits). We also stated that currently only about 7 percent of all 60-
day episodes receive a LUPA, meaning that it appears that HHAs changed
their practice patterns such that, upon implementation of the HH PPS,
more than half of 60-day episodes that would have been LUPAs received
the full 60-day episode payment amount. Additionally, while the LUPA
thresholds vary for each of the 432 case-mix groups, many of these
groups have a LUPA threshold of two, meaning if the HHA provides more
than one visit in a 30-day period, it will receive the full 30-day
payment amount. Given that many groups have only a two-visit threshold,
we believe it to be a reasonable assumption that some HHAs would
provide a second visit to receive the full 30-day payment amount. In
the CY 2019 HH PPS final rule, we finalized the three behavior
assumptions in calculating a 30-day budget-neutral payment amount given
the ample evidence-based data supporting such assumptions (83 FR
56461). In response to comments regarding the impact of the behavior
assumptions on payments and any potential access issues, in the CY 2019
HH PPS final rule (83 FR 56461), we stated that we expect that HHAs
would continue to provide home health services in accordance with the
home health Conditions of Participation regarding the provision of
services as established on the individualized home health plan of care.
We stated that we expect the provision of services to be made to best
meet the patient's care needs. We also noted that we would monitor any
changes in utilization patterns, beneficiary impact, and provider
behavior to see if any refinements to the PDGM would be warranted, or
if any concerns are identified that may signal the need for appropriate
program integrity measures.
    In order to calculate the CY 2020 proposed budget neutral 30-day
payment amounts in this proposed rule, both with and without behavior
assumptions, we first calculated the total, aggregate amount of
expenditures that would occur under the current case-mix adjustment
methodology (as described in section III.D. of this rule) and the 60-
day episode unit of payment using the CY 2019 payment parameters (for
example, CY 2019 payment rates, case-mix weights, and outlier fixed-
dollar loss ratio). That resulted in a total aggregate expenditures
target amount of $16.2 billion.\9\ We then calculated what the 30-day
payment amount would need to be set at in CY 2020, with and without
behavior assumptions, while taking into account needed changes to the
outlier fixed-dollar loss ratio under the PDGM in order to pay out no
more than 2.5 percent of total HH PPS payments as outlier payments
(refer to section III.F. of this proposed rule) and in order for
Medicare to pay out $16.2 billion in total expenditures in CY 2020 with
the application of a 30-day unit of payment under the PDGM. Table 12
includes the proposed, estimated 30-day budget-neutral payment amount
for CY 2020 both with and without the behavior assumptions. These
payment amounts do not include the CY 2020 home health payment update
of 1.5 percent.
---------------------------------------------------------------------------
    \9\ The initial 2018 analytic file included 6,606,602 60-day
episodes ($18.3 billion in total expenditures). Of these, 962,949
(14.6 percent) were excluded because they could not be linked to
OASIS assessments or because of the claims data cleaning process
reasons listed in section III.F.1 of this proposed rule. We note
that of the 962,949 claims excluded, 513,998 were excluded because
they were RAPs without a final claim or they were claims with zero
payment amounts, resulting in $17.4 billion in total expenditures.
After removing all 962,949 excluded claims, the 2018 analytic file
consisted of 5,643,653 60-day episodes ($16.3 billion in total
expenditures). 60-day episodes of duration longer than 30 days were
divided into two 30-day periods in order to calculate the 30-day
payment amounts. As noted in section III.F.1. of this proposed rule,
there were instances where 30-day periods were excluded from the
2018 analytic file (for example, we could not match the period to a
start of care or resumption of care OASIS to determine the
functional level under the PDGM, the 30-day period did not have any
skilled visits, or because information necessary to calculate
payment was missing from claim record). The final 2018 analytic file
used to calculate budget neutrality consisted of 9,127,459 30-day
periods ($16.2 billion in total expenditures) drawn from 5,338,939
60-day episodes.
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[[Page 34616]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.047
    If no behavior assumptions were made, we estimate that the CY 2020
30-day payment amount needed to achieve budget neutrality would be
$1,907.11. Applying the clinical group and comorbidity coding
assumptions, and the LUPA threshold assumption, as required by section
1895(b)(3)(A)(iv) of the Act, will result in the need to decrease the
CY 2020 estimated budget-neutral 30-day payment amount to $1,754.37 (a
8.01 percent decrease from $1,907.11). The CY 2020 estimated 30-day
budget-neutral payment amount would be slightly more than the CY 2019
estimated 30-day budget-neutral payment amount calculated in last
year's rule (that is, if the PDGM was implemented in CY 2019), which we
estimated to be $1,753.68. However, the CY 2019 estimated 30-day
payment amount of $1,753.68 included the CY 2019 market basket update
of 2.1 percent whereas the CY 2020 estimated 30-day budget neutral
payment amount of $1,754.37 does not include the 1.5 percent home
health legislated payment update for CY 2020. Applying the proposed CY
2020 Wage Index Budget Neutrality Factor and the 1.5 percent home
health update would increase the CY 2020 national, standardized 30-day
payment amount to $1,791.73 and is further described in section III.E.
of this proposed rule. The CY 2020 proposed estimated payment rate of
$1,791.73 is approximately 14 percent more than the estimated CY 2020
30-day period cost of $1,577.52, as shown in Table 5 of this proposed
rule. We invite comments on the CY 2020 proposed, estimated 30-day
budget-neutral payment amount with the behavior assumptions as
described previously in this proposed rule and in Table 12.
    The 30-day payment amount will be for 30-day periods of care
beginning on and after January 1, 2020. Because CY 2020 is the first
year of the PDGM and the change to a 30-day unit of payment, there will
be a transition period to account for those home health episodes of
care that span the implementation date. Therefore, for 60-day episodes
(that is, not LUPA episodes) that begin on or before December 31, 2019
and end on or after January 1, 2020 (episodes that would span the
January 1, 2020 implementation date), payment made under the Medicare
HH PPS will be the CY 2020 national, standardized 60-day episode
payment amount as described in section III.X. of this proposed rule.
For home health periods of care that begin on or after January 1, 2020,
the unit of service will be a 30-day period and payment made under the
Medicare HH PPS will be the CY 2020 national, standardized prospective
30-day payment amount as described in section III.X. of this proposed
rule. For home health units of service that begin on or after December
3, 2020 through December 31, 2020 and end on or after January 1, 2021,
the HHA will be paid the CY 2021 national, standardized prospective 30-
day payment amount.
    We note that we are also required under section 1895(b)(3)(D)(i) of
the Act, as added by section 51001(a)(2)(B) of the BBA of 2018, to
analyze data for CYs 2020 through 2026, after implementation of the 30-
day unit of payment and new case-mix adjustment methodology, to
annually determine the impact of differences between assumed behavior
changes and actual behavior changes on estimated aggregate
expenditures. We interpret actual behavior change to encompass both
behavior changes that were previously outlined, as assumed by CMS when
determining the budget-neutral 30-day payment amount for CY 2020, and
other behavior changes not identified at the time the 30-day payment
amount for CY 2020 is determined. The data from CYs 2020 through 2026
will be available to determine whether a prospective adjustment
(increase or decrease) is needed no earlier than in years 2022 through
2028 rulemaking. However, we will analyze data after implementation of
the PDGM to determine if there are any notable and consistent trends to
warrant whether any changes to the national, standardized 30-day
payment rate should be done earlier than CY 2022.
    As noted previously, under section 1895(b)(3)(D)(ii) of the Act, we
are required to provide one or more permanent adjustments to the 30-day
payment amount on a prospective basis, if needed, to offset increases
or decreases in estimated aggregate expenditures as calculated under
section 1895(b)(3)(D)(i) of the Act. Clause (iii) of section
1895(b)(3)(D) of the Act requires the Secretary to make temporary
adjustments to the 30-day payment amount, on a prospective basis, in
order to offset increases or decreases in estimated aggregate
expenditures, as determined under clause (i) of such section. The
temporary adjustments allow us to recover excess spending or give back
the difference between actual and estimated spending (if actual is less
than estimated) not addressed by permanent adjustments.
[[Page 34617]]
However, any permanent or temporary adjustments to the 30-day payment
amount to offset increases or decreases in estimated aggregate
expenditures as calculated under section 1895(b)(3)(D)(i) and (iii) of
the Act would be subject to proposed notice and comment rulemaking.
    We are soliciting comments on the behavior assumptions finalized in
the CY 2019 HH PPS final rule regarding any potential issues that may
result from taking these assumptions into account when establishing the
initial 30-day payment amount for CY 2020. We reiterate that if CMS
underestimates the reductions to the 30-day payment amount necessary to
offset behavior changes and maintain budget neutrality, larger
adjustments to the 30-day payment amount would be required in the
future, by law, to ensure budget neutrality. Likewise, if CMS
overestimates the reductions, we are required to make the appropriate
payment adjustments accordingly as described previously.
    We wish to remind stakeholders again that CMS will provide, upon
request, a Home Health Claims-OASIS LDS file to accompany the CY 2020
proposed and final rules to support HHAs in evaluating the effects of
the PDGM. The Home Health Claims-OASIS LDS file can be requested by
following the instructions on the following CMS website https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html. Additionally, we will
post CY 2020 provider-level impacts and an updated Interactive Grouper
Tool on the HHA Center web page \10\ and the PDGM dedicated web page
\11\ to provide HHAs with ample tools to help them understand the
impact of the PDGM and the change to a 30-day unit of payment.
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    \10\ https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html.
    \11\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html.
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C. Proposed CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes of Care
That Span the Implementation Date of the PDGM
    In the CY 2015 HH PPS final rule (79 FR 66072), we finalized a
policy to annually recalibrate the HH PPS case-mix weights--adjusting
the weights relative to one another--using the most current, complete
data available. Annual recalibration of the HH PPS case-mix weights
ensures that the case-mix weights reflect, as accurately as possible,
current home health resource use and changes in utilization patterns.
In this proposed rule, we are detailing implementation of the PDGM and
a change in the unit of home health payment to 30-day periods of care
as described in section III.A and III.B. of this proposed rule. As
such, we are recalibrating the CY 2020 case-mix weights for 30-day
periods of care using the PDGM methodology as described in section
III.D. of the proposed rule. However, these recalibrated case-mix
weights are not applicable for those 60-day episodes of care that begin
on or before December 31, 2019 and end on or after January 1, 2020.
Therefore, we are not proposing to separately recalibrate the case-mix
weights for those 60-day episodes that span the January 1, 2020
implementation date.
    Instead, we are proposing that these 60-day episodes would be paid
the national, standardized 60-day episode payment amount as described
in section III.E. of this rule and will be case-mix adjusted using the
CY 2019 case-mix weights as listed in Table 6 in the CY 2019 HH PPS
final rule (83 FR 56422) and posted on the HHA Center web page.\12\ We
believe that this is a reasonable approach for case-mix adjusting these
60-day episodes of care that span the January 1, 2020 implementation
date. With the implementation of a new case-mix adjustment methodology
and a move to a 30-day unit of payment, we believe this approach would
be less burdensome for HHAs as they will not have to download a new,
separate 153-group case-mix weight data file, in addition to the 432
case-mix weight data file for CY 2020. For those 60-day episodes that
end after January 1, 2020, but where there is a continued need for home
health services, we are proposing that any subsequent periods of care
would be paid the 30-day national, standardized payment amount with the
appropriate CY 2020 PDGM case-mix weight applied. We are soliciting
comments on this proposal regarding payment for those 60-day episodes
of care that span the implementation date of the PDGM and the change to
a 30-day unit of payment.
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    \12\ https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html.
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D. Proposed CY 2020 PDGM Low-Utilization Payment Adjustment (LUPA)
Thresholds and PDGM Case-Mix Weights
1. Proposed CY 2020 PDGM LUPA Thresholds
    Under the current 153-group payment system, a 60-day episode with
four or fewer visits is paid the national per-visit amount by
discipline, adjusted by the appropriate wage index based on the site of
service of the beneficiary, instead of the full 60-day episode payment
amount. Such payment adjustments are called Low Utilization Payment
Adjustments (LUPAs). In the current payment system, approximately 7 to
8 percent of episodes are LUPAs.
    LUPAs will still be paid upon implementation of the PDGM. However,
the approach to calculating the LUPA thresholds has changed due to the
change in the unit of payment to 30-day periods of care from 60-day
episodes. As detailed in the CY 2019 HH PPS proposed rule (83 FR
32411), there are substantially more home health periods of care with
four or fewer visits in a 30-day period than in 60-day episodes;
therefore, we believe that the LUPA thresholds for 30-day periods of
care should be correspondingly adjusted to target approximately the
same percentage of LUPA episodes as under the current HH PPS case-mix
system, which is approximately 7 to 8 percent of all episodes. To
target approximately the same percentage of LUPAs under the PDGM, LUPA
thresholds are set at the 10th percentile value of visits or 2 visits,
whichever is higher, for each payment group. This means that the LUPA
threshold for each 30-day period of care varies depending on the PDGM
payment group to which it is assigned. In the CY 2019 HH PPS final rule
(83 FR 56492), we finalized that the LUPA thresholds for each PDGM
payment group will be reevaluated every year based on the most current
utilization data available at the time of rulemaking. Therefore, we
used CY 2018 Medicare home health claims (as of March 27, 2019) linked
to OASIS assessment data for this proposed rule. The proposed LUPA
thresholds for the CY 2020 PDGM payment groups with the corresponding
Health Insurance Prospective Payment System (HIPPS) codes and the case-
mix weights are listed in Table 8. Under the PDGM, if the LUPA
threshold is met, the 30-day period of care will be paid the full 30-
day period payment. If a 30-day period of care does not meet the PDGM
LUPA visit threshold, as detailed previously, then payment will be made
using the CY 2020 per-visit payment amounts. For example, if the LUPA
visit threshold is four, and a 30-day period of care has four or more
visits, it is paid the full 30-day period payment amount; if the period
of care has three or less visits, payment is made using the per-visit
payment amounts.
[[Page 34618]]
2. Proposed CY 2020 PDGM Case-Mix Weights
    Section 1895(b)(4)(B) of the Act requires the Secretary to
establish appropriate case mix adjustment factors for home health
services in a manner that explains a significant amount of the
variation in cost among different units of services. As finalized in
the CY 2019 HH PPS final rule (83 FR 56502), the PDGM places patients
into meaningful payment categories based on patient characteristics
(principal diagnosis, functional level, comorbid conditions, referral
source and timing). The PDGM case-mix methodology results in 432 unique
case-mix groups called HHRGs.
    To generate the CY 2020 PDGM case-mix weights, we utilized a data
file based on home health 30-day periods of care, as reported in CY
2018 Medicare home health claims (as of March 2019) linked to OASIS
assessment data to obtain patient characteristics. These data are the
most current and complete data available at this time. The claims data
provides visit-level data and data on whether NRS was provided during
the period and the total charges of NRS. We determine the case-mix
weight for each of the 432 different PDGM payment groups by regressing
resource use on a series of indicator variables for each of the
categories using a fixed effects model as described in the steps
detailed in this section of this proposed rule.
    Step 1: Estimate a regression model to assign a functional
impairment level to each 30-day period. The regression model estimates
the relationship between a 30-day period's resource use and the
functional status and risk of hospitalization items included in the
PDGM which are obtained from certain OASIS items. We measure resource
use with the cost-per-minute + NRS approach that uses information from
home health cost reports. Other variables in the regression model
include the 30-day period's admission source; clinical group; and 30-
day period timing. We also include home health agency level fixed
effects in the regression model. After estimating the regression model
using 30-day periods, we divide the coefficients that correspond to the
functional status and risk of hospitalization items by 10 and round to
the nearest whole number. Those rounded numbers are used to compute a
functional score for each 30-day period by summing together the rounded
numbers for the functional status and risk of hospitalization items
that are applicable to each 30-day period. Next, each 30-day period is
assigned to a functional impairment level (low, medium, or high)
depending on the 30-day period's total functional score. Each clinical
group has a separate set of functional thresholds used to assign 30-day
periods into a low, medium or high functional impairment level. We set
those thresholds so that we assign roughly a third of 30-day periods
within each clinical group to each functional impairment level (low,
medium, or high).
    Step 2: Next, a second regression model estimates the relationship
between a 30-day period's resource use and indicator variables for the
presence of any of the comorbidities and comorbidity interactions that
were originally examined for inclusion in the PDGM. Like the first
regression model, this model also includes home health agency level
fixed effects and includes control variables for each 30-day period's
admission source, clinical group, timing, and functional impairment
level. After we estimate the model, we assign comorbidities to the low
comorbidity adjustment if any comorbidities have a coefficient that is
statistically significant (p-value of .05 or less) and which have a
coefficient that is larger than the 50th percentile of positive and
statistically significant comorbidity coefficients. If two
comorbidities in the model and their interaction term have coefficients
that sum together to exceed $150 and the interaction term is
statistically significant (p-value of .05 or less), we assign the two
comorbidities together to the high comorbidity adjustment.
    Step 3: After Step 2, each 30-day period is assigned to a clinical
group, admission source category, episode timing category, functional
impairment level, and comorbidity adjustment category. For each
combination of those variables (which represent the 432 different
payment groups that comprise the PDGM), we then calculate the 10th
percentile of visits across all 30-day periods within a particular
payment group. If a 30-day period's number of visits is less than the
10th percentile for their payment group, the 30-day period is
classified as a Low Utilization Payment Adjustment (LUPA). If a payment
group has a 10th percentile of visits that is less than two, we set the
LUPA threshold for that payment group to be equal to two. That means if
a 30-day period has one visit, it is classified as a LUPA and if it has
two or more visits, it is not classified as a LUPA.
    Step 4: Finally, we take all non-LUPA 30-day periods and regress
resource use on the 30-day period's clinical group, admission source
category, episode timing category, functional impairment level, and
comorbidity adjustment category. The regression includes fixed effects
at the level of the home health agency. After we estimate the model,
the model coefficients are used to predict each 30-day period's
resource use. To create the case-mix weight for each 30-day period, the
predicted resource use is divided by the overall resource use of the
30-day periods used to estimate the regression.
    The case-mix weight is then used to adjust the base payment rate to
determine each 30-day period's payment. Table 13 shows the coefficients
of the payment regression used to generate the weights, and the
coefficients divided by average resource use.
[[Page 34619]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.048
    Table 14 presents the HIPPS code, the LUPA threshold, and the case-
mix weight for each Home Health Resource Group (HHRG) in the regression
model.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
E. Proposed CY 2020 Home Health Payment Rate Updates
1. Proposed CY 2020 Home Health Market Basket Update for HHAs
    Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2020 be increased by a factor equal
to the applicable home health market basket update for those HHAs that
submit quality data as required by the Secretary. In the CY 2019 HH PPS
final rule (83 FR 56425), we finalized a rebasing of the home health
market basket to reflect 2016 Medicare cost report (MCR) data, the
latest available and complete data on the actual structure of HHA
costs. As such, based on the rebased 2016-based home health market
basket, we finalized that the labor-related share is 76.1 percent and
the non-labor-related share is 23.9 percent. A detailed description of
how we rebased the HHA market basket is available in the CY 2019 HH PPS
final rule (83 FR 56425 through 56436).
    Section 1895(b)(3)(B) of the Act, requires that, in CY 2015 and in
subsequent calendar years, except CY 2018 (under section 411(c) of the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
114-10, enacted April 16, 2015)), and except in CY 2020 (under section
53110 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123,
enacted February 9, 2018)), the market basket percentage under the HHA
prospective payment system, as described in section 1895(b)(3)(B) of
the Act, be annually adjusted by changes in economy-wide productivity.
Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity
adjustment to be equal to the 10-year moving average of change in
annual economy-wide private nonfarm business multifactor productivity
(MFP) (as projected by the Secretary for the 10-year period ending with
the applicable fiscal year, calendar year, cost reporting period, or
other annual period) (the ``MFP adjustment''). The Bureau of Labor
Statistics (BLS) is the agency that publishes the official measure of
private nonfarm business MFP. Please see http://www.bls.gov/mfp, to
obtain the BLS historical published MFP data.
    The proposed home health update percentage for CY 2020 would have
been based on the estimated home health market basket update, specified
at section 1895(b)(3)(B)(iii) of the Act, of 3.0 percent (based on IHS
Global Insight Inc.'s first-quarter 2019 forecast with historical data
through fourth-quarter 2018). Due to the requirements specified at
section 1895(b)(3)(B)(vi) of the Act prior to the enactment of the BBA
of 2018, the estimated CY 2020 home health market basket update of 3.0
percent would have been reduced by a MFP adjustment, as mandated by the
section 3401 of the Patient Protection and Affordable Care Act (the
Affordable Care Act) (Pub. L. 111-148) and currently estimated to be
0.4 percentage point for CY 2020. In effect, the proposed home health
payment update percentage for CY 2020 would have been a 2.6 percent
increase. However, section 53110 of the BBA of 2018 amended section
1895(b)(3)(B) of the Act, such that for home health payments for CY
2020, the home health payment update is required to be 1.5 percent. The
MFP adjustment is not applied to the BBA of 2018 mandated 1.5 percent
payment update. Section 1895(b)(3)(B)(v) of the Act requires that the
home health update be decreased by 2 percentage points for those HHAs
that do not submit quality data as required by the Secretary. For HHAs
that do not submit the required quality data for CY 2020, the home
health payment update would be -0.5 percent (1.5 percent minus 2
percentage points).
2. CY 2020 Home Health Wage Index
    Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the
Secretary to provide appropriate adjustments to the proportion of the
payment amount under the HH PPS that account for area wage differences,
using adjustment factors that reflect the relative level of wages and
wage-related costs applicable to the furnishing of HH services. Since
the inception of the HH PPS, we have used inpatient hospital wage data
in developing a wage index to be applied to HH payments. We propose to
continue this practice for CY 2020, as we continue to believe that, in
the absence of HH-specific wage data that accounts for area
differences, using inpatient hospital wage data is appropriate and
reasonable for the HH PPS. Specifically, we propose to use the FY 2020
pre-floor, pre-reclassified hospital wage index as the CY 2020 wage
adjustment to the labor portion of the HH PPS rates. For CY 2020, the
updated wage data are for hospital cost reporting periods beginning on
or after October 1, 2015, and before October 1, 2016 (FY 2016 cost
report data). We apply the appropriate wage index value to the labor
portion of the HH PPS rates based on the site of service for the
beneficiary (defined by section 1861(m) of the Act as the beneficiary's
place of residence).
    To address those geographic areas in which there are no inpatient
hospitals, and thus, no hospital wage data on which to base the
calculation of the CY 2020 HH PPS wage index, we propose to continue to
use the same methodology discussed in the CY 2007 HH PPS final rule (71
FR 65884) to address those geographic areas in which there are no
inpatient hospitals. For rural areas that do not have inpatient
hospitals, we propose to use the average wage index from all contiguous
Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently,
the only
[[Page 34629]]
rural area without a hospital from which hospital wage data could be
derived is Puerto Rico. However, for rural Puerto Rico, we do not apply
this methodology due to the distinct economic circumstances that exist
there (for example, due to the close proximity to one another of almost
all of Puerto Rico's various urban and non-urban areas, this
methodology would produce a wage index for rural Puerto Rico that is
higher than that in half of its urban areas). Instead, we propose to
continue to use the most recent wage index previously available for
that area. For urban areas without inpatient hospitals, we use the
average wage index of all urban areas within the state as a reasonable
proxy for the wage index for that CBSA. For CY 2020, the urban areas
without inpatient hospital wage data are Hinesville, GA (CBSA 25980)
and Carson City, NV (CBSA 16180). The CY 2020 wage index value for
Hinesville, GA is 0.8237 and the wage index value for Carson City, NV
is 1.0518.
    On February 28, 2013, OMB issued Bulletin No. 13-01, announcing
revisions to the delineations of MSAs, Micropolitan Statistical Areas,
and CBSAs, and guidance on uses of the delineation of these areas. In
the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted
the OMB's new area delineations using a 1-year transition.
    On August 15, 2017, OMB issued Bulletin No. 17-01 in which it
announced that one Micropolitan Statistical Area, Twin Falls, Idaho,
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300)
comprises the principal city of Twin Falls, Idaho in Jerome County,
Idaho and Twin Falls County, Idaho. The CY 2020 HH PPS wage index value
for CBSA 46300, Twin Falls, Idaho, will be 0.8252. Bulletin No. 17-01
is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.\13\
---------------------------------------------------------------------------
    \13\ ``Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN
NO. 17-01. August 15, 2017. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
---------------------------------------------------------------------------
    The most recent OMB Bulletin (No. 18-04) was published on September
14, 2018 and is available at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.\14\
---------------------------------------------------------------------------
    \14\ Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN
NO. 18-04. September 14, 2018. https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
---------------------------------------------------------------------------
    The revisions contained in OMB Bulletin No. 18-04 have no impact on
the geographic area delineations that are used to wage adjust HH PPS
payments.
    The CY 2020 wage index is available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. We
were recently made aware of a minor calculation error in the file used
to compute the home health wage index values. We are also posting the
corrected wage index values in the same file, on the same website and
we will correct this error when computing the home health wage index
values and payment rates for the final rule.
3. Comment Solicitation
    Historically, we have calculated the home health wage index values
using unadjusted wage index values from another provider setting.
Stakeholders have frequently commented on certain aspects of the home
health wage index values and their impact on payments. We are
soliciting comments on concerns stakeholders may have regarding the
wage index used to adjust home health payments and suggestions for
possible updates and improvements to the geographic adjustment of home
health payments.
4. CY 2020 Annual Payment Update
a. Background
    The Medicare HH PPS has been in effect since October 1, 2000. As
set forth in the July 3, 2000 final rule (65 FR 41128), the base unit
of payment under the Medicare HH PPS was a national, standardized 60-
day episode payment rate. As finalized in the CY 2019 HH PPS final rule
(83 FR 56406) and as described in section III.B of this proposed rule,
the unit of home health payment will change from a 60-day episode to a
30-day period effective for those 30-day periods beginning on or after
January 1, 2020. However, the standardized 60-day payment rate will
apply to case-mix adjusted episodes (that is, not LUPAs) beginning on
or before December 31, 2019 and ending on or before February 28, 2020.
As such, the latest date such a 60-day crossover episode could end on
is February 28, 2020. Those 60-day episodes that begin on or before
December 31, 2019, but are LUPA episodes, will be paid the national,
per-visit payment rates as shown in Table 23.
    As set forth in Sec.  484.220, we adjust the national, standardized
prospective payment rates by a case-mix relative weight and a wage
index value based on the site of service for the beneficiary. To
provide appropriate adjustments to the proportion of the payment amount
under the HH PPS to account for area wage differences, we apply the
appropriate wage index value to the labor portion of the HH PPS rates.
In the CY 2019 HH PPS final rule (83 FR 56435), we finalized to rebase
and revise the home health market basket to reflect 2016 Medicare cost
report (MCR) data, the latest available and most complete data on the
actual structure of HHA costs. We also finalized a revision to the
labor-related share to reflect the 2016-based home health market basket
Compensation (Wages and Salaries plus Benefits) cost weight. We
finalized that for CY 2019 and subsequent years, the labor-related
share would be 76.1 percent and the non-labor-related share would be
23.9 percent. The following are the steps we take to compute the case-
mix and wage-adjusted 60-day episode (for those episodes that span the
implementation date of January 1, 2020) and 30-day period rates for CY
2020:
     Multiply the national, standardized 60-day episode rate or
30-day period rate by the patient's applicable case-mix weight.
     Divide the case-mix adjusted amount into a labor (76.1
percent) and a non-labor portion (23.9 percent).
     Multiply the labor portion by the applicable wage index
based on the site of service of the beneficiary.
     Add the wage-adjusted portion to the non-labor portion,
yielding the case-mix and wage adjusted 60-day episode rate or 30-day
period rate, subject to any additional applicable adjustments.
    We provide annual updates of the HH PPS rate in accordance with
section 1895(b)(3)(B) of the Act. Section 484.225 sets forth the
specific annual percentage update methodology. In accordance with
section 1895(b)(3)(B)(v) of the Act and Sec.  484.225(i), for an HHA
that does not submit HH quality data, as specified by the Secretary,
the unadjusted national prospective 60-day episode rate or 30-day
period rate is equal to the rate for the previous calendar year
increased by the applicable HH payment update, minus 2 percentage
points. Any reduction of the percentage change would apply only to the
calendar year involved and would not be considered in computing the
prospective payment amount for a subsequent calendar year.
    Medicare pays both the national, standardized 60-day and 30-day
case-mix and wage-adjusted payment amounts on a split percentage
payment approach for those HHAs eligible for such payments. The split
percentage payment approach includes an initial percentage payment and
a final
[[Page 34630]]
percentage payment as set forth in Sec.  484.205(b)(1) and (2). The
claim that the HHA submits for the final percentage payment determines
the total payment amount for the episode or period and whether we make
an applicable adjustment to the 60-day or 30-day case-mix and wage-
adjusted payment amount. We refer stakeholders to section III.H. of
this proposed rule regarding proposals on changes to the current split
percentage policy in CY 2020 and subsequent years. The end date of the
60-day episode or 30-day period, as reported on the claim, determines
which calendar year rates Medicare will use to pay the claim.
    We may also adjust the 60-day or 30-day case-mix and wage-adjusted
payment based on the information submitted on the claim to reflect the
following:
     A low-utilization payment adjustment (LUPA) is provided on
a per-visit basis as set forth in Sec. Sec.  484.205(d)(1) and 484.230.
     A partial episode payment (PEP) adjustment as set forth in
Sec. Sec.  484.205(d)(2) and 484.235.
     An outlier payment as set forth in Sec. Sec.
484.205(d)(3) and 484.240.
b. CY 2020 National, Standardized 60-Day Episode Payment Rate
    Section 1895(b)(3)(A)(i) of the Act requires that the standard,
prospective payment rate and other applicable amounts be standardized
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a
budget neutral manner. To determine the CY 2020 national, standardized
60-day episode payment rate for those 60-day episodes that span the
implementation date of the PDGM and the change to a 30-day unit of
payment, we apply a wage index budget neutrality factor and the home
health payment update percentage discussed in section III.F.1. of this
proposed rule. We are not proposing to update the case-mix weights for
the 153-group case-mix methodology in CY 2020 as outlined in section
III.D. of this proposed rule. Because we would continue to use the CY
2019 case-mix weights, we do not have to apply a case-mix weight budget
neutrality factor to the CY 2020 60-day episode payment rate.
    To calculate the wage index budget neutrality factor, we simulated
total payments for non-LUPA episodes using the proposed CY 2020 wage
index and compared it to our simulation of total payments for non-LUPA
episodes using the CY 2019 wage index. By dividing the total payments
for non-LUPA episodes using the CY 2020 wage index by the total
payments for non-LUPA episodes using the CY 2019 wage index, we obtain
a wage index budget neutrality factor of 1.0062. We would apply the
wage index budget neutrality factor of 1.0062 to the calculation of the
CY 2019 national, standardized 60-day episode payment rate.
    Next, we would update the 60-day payment rate by the CY 2020 home
health payment update percentage of 1.5 percent as required by section
53110 of the BBA of 2018 and as described in section III.E.1. of this
proposed rule. The CY 2020 national, standardized 60-day episode
payment rate is calculated in Table 15.
[GRAPHIC] [TIFF OMITTED] TP18JY19.058
    The CY 2020 national, standardized 60-day episode payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2020 home health payment update of 1.5 percent minus 2 percentage
points and is shown in Table 16.
[GRAPHIC] [TIFF OMITTED] TP18JY19.059
 c. CY 2020 Non-Routine Medical Supply (NRS) Payment Rates for CY 2020
60-Day Episodes of Care
    All medical supplies (routine and non-routine) must be provided by
the HHA while the patient is under a home health plan of care. Examples
of supplies that can be considered non-routine include dressings for
wound care, IV supplies, ostomy supplies, catheters, and catheter
supplies. Payments for NRS are computed by multiplying the relative
weight for a particular severity level by the NRS conversion factor. To
determine the CY
[[Page 34631]]
2020 NRS conversion factor, we updated the CY 2019 NRS conversion
factor ($54.20) by the CY 2020 home health payment update percentage of
1.5 percent. We did not apply a standardization factor as the NRS
payment amount calculated from the conversion factor is not wage or
case-mix adjusted when the final claim payment amount is computed. The
proposed NRS conversion factor for CY 2020 is shown in Table 17.
[GRAPHIC] [TIFF OMITTED] TP18JY19.060
    Using the CY 2020 NRS conversion factor, the payment amounts for
the six severity levels are shown in Table 18.
[GRAPHIC] [TIFF OMITTED] TP18JY19.061
    For HHAs that do not submit the required quality data, we updated
the CY 2019 NRS conversion factor ($54.20) by the CY 2019 home health
payment update percentage of 1.5 percent minus 2 percentage points. To
determine the CY 2020 NRS conversion factor for HHAs that do not submit
the required quality data we multiplied the CY 2019 NRS conversion
factor ($54.20) by the CY 2020 HH Payment Update (0.995) to determine
the CY 2020 NRS conversion factor ($53.93). The proposed CY 2020 NRS
conversion factor for HHAs that do not submit quality data is shown in
Table 19.
[GRAPHIC] [TIFF OMITTED] TP18JY19.062
    The payment amounts for the various severity levels based on the
updated conversion factor for HHAs that do not submit quality data are
calculated in Table 20.
[[Page 34632]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.063
    In CY 2020, the NRS payment amounts apply to only those 60-day
episodes that begin on or before December 31, 2019 but span the
implementation of the PDGM and the 30-day unit of payment on January 1,
2020 (ending on February 28, 2020). Under the PDGM, NRS payments are
included in the 30-day base payment rate.
d. CY 2020 National, Standardized 30-Day Period Payment Amount
    Section 1895(b)(3)(A)(i) of the Act requires that the standard
prospective payment rate and other applicable amounts be standardized
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a
budget-neutral manner. To determine the CY 2020 national, standardized
30-day period payment rate, we apply a wage index budget neutrality
factor; and the home health payment update percentage discussed in
section III.E.1. of this proposed rule.
    To calculate the wage index budget neutrality factor, we simulated
total payments for non-LUPA episodes using the proposed CY 2020 wage
index and compared it to our simulation of total payments for non-LUPA
episodes using the CY 2019 wage index. By dividing the total payments
for non-LUPA episodes using the CY 2020 wage index by the total
payments for non-LUPA episodes using the CY 2019 wage index, we obtain
a wage index budget neutrality factor of 1.0062. We would apply the
wage index budget neutrality factor of 1.0062 to the calculation of the
CY 2019 national, standardized 30-day period payment rate as described
in section III.B. of this proposed rule.
    We note that in past years, a case-mix budget neutrality factor was
annually applied to the HH PPS base rates to account for the change
between the previous year's case-mix weights and the newly recalibrated
case-mix weights. Since CY 2020 is the first year of PDGM, there is no
way to do a case-mix budget neutrality factor in this manner. However,
in future years under the PDGM, we would apply a case-mix budget
neutrality factor with the annual payment update in order to account
for the change between the previous year's PDGM case-mix weights.
    Next, we would update the 30-day payment rate by the CY 2020 home
health payment update percentage of 1.5 percent as required by section
53110 of the BBA of 2018 and as described in section III.F.1. of this
proposed rule. The CY 2020 national, standardized 30-day period payment
rate is calculated in Table 21.
[GRAPHIC] [TIFF OMITTED] TP18JY19.064
    The CY 2020 national, standardized 30-day episode payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2020 home health payment update of 1.5 percent minus 2 percentage
points and is shown in Table 22.
[[Page 34633]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.065
e. CY 2020 National Per-Visit Rates for Both 60-Day Episodes of Care
and 30-Day Periods of Care
    The national per-visit rates are used to pay LUPAs and are also
used to compute imputed costs in outlier calculations. The per-visit
rates are paid by type of visit or HH discipline. The six HH
disciplines are as follows:
     Home health aide (HH aide).
     Medical Social Services (MSS).
     Occupational therapy (OT).
     Physical therapy (PT).
     Skilled nursing (SN).
     Speech-language pathology (SLP).
    To calculate the CY 2020 national per-visit rates, we started with
the CY 2019 national per-visit rates. Then we applied a wage index
budget neutrality factor to ensure budget neutrality for LUPA per-visit
payments. We calculated the wage index budget neutrality factor by
simulating total payments for LUPA episodes using the CY 2020 wage
index and comparing it to simulated total payments for LUPA episodes
using the CY 2019 wage index. By dividing the total payments for LUPA
episodes using the CY 2020 wage index by the total payments for LUPA
episodes using the CY 2019 wage index, we obtained a wage index budget
neutrality factor of 1.0066. We apply the wage index budget neutrality
factor of 1.0066 in order to calculate the CY 2020 national per-visit
rates.
    The LUPA per-visit rates are not calculated using case-mix weights.
Therefore, no case-mix weights budget neutrality factor is needed to
ensure budget neutrality for LUPA payments. Lastly, the per-visit rates
for each discipline are updated by the CY 2020 home health payment
update percentage of 1.5 percent. The national per-visit rates are
adjusted by the wage index based on the site of service of the
beneficiary. The per-visit payments for LUPAs are separate from the
LUPA add-on payment amount, which is paid for episodes that occur as
the only episode or initial episode in a sequence of adjacent episodes.
The CY 2020 national per-visit rates for HHAs that submit the required
quality data are updated by the CY 2020 HH payment update percentage of
1.5 percent and are shown in Table 23.
[GRAPHIC] [TIFF OMITTED] TP18JY19.066
    The CY 2020 per-visit payment rates for HHAs that do not submit the
required quality data are updated by the CY 2020 HH payment update
percentage of 1.5 percent minus 2 percentage points and are shown in
Table 24.
[[Page 34634]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.067
f. Rural Add-On Payments for CYs 2020 Through 2022
1. Background
    Section 421(a) of the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA) (Pub. L. 108-173) required, for HH
services furnished in a rural area (as defined in section 1886(d)(2)(D)
of the Act), for episodes or visits ending on or after April 1, 2004,
and before April 1, 2005, that the Secretary increase the payment
amount that otherwise would have been made under section 1895 of the
Act for the services by 5 percent. Section 5201 of the Deficit
Reduction Act of 2003 (DRA) (Pub. L. 108-171) amended section 421(a) of
the MMA. The amended section 421(a) of the MMA required, for HH
services furnished in a rural area (as defined in section 1886(d)(2)(D)
of the Act), on or after January 1, 2006, and before January 1, 2007,
that the Secretary increase the payment amount otherwise made under
section 1895 of the Act for those services by 5 percent.
    Section 3131(c) of the Affordable Care Act amended section 421(a)
of the MMA to provide an increase of 3 percent of the payment amount
otherwise made under section 1895 of the Act for HH services furnished
in a rural area (as defined in section 1886(d)(2)(D) of the Act), for
episodes and visits ending on or after April 1, 2010, and before
January 1, 2016. Section 210 of the MACRA amended section 421(a) of the
MMA to extend the rural add-on by providing an increase of 3 percent of
the payment amount otherwise made under section 1895 of the Act for HH
services provided in a rural area (as defined in section 1886(d)(2)(D)
of the Act), for episodes and visits ending before January 1, 2018.
    Section 50208(a) of the BBA of 2018 amended section 421(a) of the
MMA to extend the rural add-on by providing an increase of 3 percent of
the payment amount otherwise made under section 1895 of the Act for HH
services provided in a rural area (as defined in section 1886(d)(2)(D)
of the Act), for episodes and visits ending before January 1, 2019.
2. Rural Add-On Payments for CYs 2020 Through 2022
    Section 50208(a)(1)(D) of the BBA of 2018 added a new subsection
(b) to section 421 of the MMA to provide rural add-on payments for
episodes or visits ending during CYs 2019 through 2022. It also
mandated implementation of a new methodology for applying those
payments. Unlike previous rural add-ons, which were applied to all
rural areas uniformly, the extension provided varying add-on amounts
depending on the rural county (or equivalent area) classification by
classifying each rural county (or equivalent area) into one of three
distinct categories: (1) Rural counties and equivalent areas in the
highest quartile of all counties and equivalent areas based on the
number of Medicare home health episodes furnished per 100 individuals
who are entitled to, or enrolled for, benefits under Part A of Medicare
or enrolled for benefits under part B of Medicare only, but not
enrolled in a Medicare Advantage plan under part C of Medicare (the
``High utilization'' category); (2) rural counties and equivalent areas
with a population density of 6 individuals or fewer per square mile of
land area and are not included in the ``High utilization'' category
(the ``Low population density'' category); and (3) rural counties and
equivalent areas not in either the ``High utilization'' or ``Low
population density'' categories (the ``All other'' category).
    In the CY 2019 HH PPS final rule (83 FR 56443), CMS finalized
policies for the rural add-on payments for CY 2019 through CY 2022, in
accordance with section 50208 of the BBA of 2018. The CY 2019 HH PPS
proposed rule (83 FR 32373) described the provisions of the rural add-
on payments, the methodology for applying the new payments, and
outlined how we categorized rural counties (or equivalent areas) based
on claims data, the Medicare Beneficiary Summary File and Census data.
The data used to categorize each county or equivalent area is available
in the Downloads section associated with the publication of this rule
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file containing the rural county or
equivalent area name, their Federal Information Processing Standards
(FIPS) state and county codes, and their designation into one of the
three rural add-on categories is available for download.
    The HH PRICER module, located within CMS' claims processing system,
will increase the proposed CY 2020 60-day and 30-day base payment rates
described in section III.E. of this proposed rule by the appropriate
rural add-on percentage prior to applying any case-mix and wage index
adjustments. The CY 2020 through 2022 rural add-on percentages outlined
in law are shown in Table 25.
[[Page 34635]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.068
g. Low-Utilization Payment Adjustment (LUPA) Add-On Factors and Partial
Payment Adjustments
    Currently, LUPA episodes qualify for an add-on payment when the
episode is the first or only episode in a sequence of adjacent
episodes. As stated in the CY 2008 HH PPS final rule, LUPA add-on
payments are made because the national per-visit payment rates do not
adequately account for the front-loading of costs for the first LUPA
episode of care as the average visit lengths in these initial LUPAs are
16 to 18 percent higher than the average visit lengths in initial non-
LUPA episodes (72 FR 49848). LUPA episodes that occur as the only
episode or as an initial episode in a sequence of adjacent episodes are
adjusted by applying an additional amount to the LUPA payment before
adjusting for area wage differences. In the CY 2014 HH PPS final rule
(78 FR 72305), we changed the methodology for calculating the LUPA add-
on amount by finalizing the use of three LUPA add-on factors: 1.8451
for SN; 1.6700 for PT; and 1.6266 for SLP. We multiply the per-visit
payment amount for the first SN, PT, or SLP visit in LUPA episodes that
occur as the only episode or an initial episode in a sequence of
adjacent episodes by the appropriate factor to determine the LUPA add-
on payment amount.
    In the CY 2019 HH PPS final rule (83 FR 56440), we finalized our
policy of continuing to multiply the per-visit payment amount for the
first skilled nursing, physical therapy, or speech-language pathology
visit in LUPA periods that occur as the only period of care or the
initial 30-day period of care in a sequence of adjacent 30-day periods
of care by the appropriate add-on factor (1.8451 for SN, 1.6700 for PT,
and 1.6266 for SLP) to determine the LUPA add-on payment amount for 30-
day periods of care under the PDGM. For example, using the proposed CY
2020 per-visit payment rates for those HHAs that submit the required
quality data, for LUPA periods that occur as the only period or an
initial period in a sequence of adjacent periods, if the first skilled
visit is SN, the payment for that visit will be $276.14 (1.8451
multiplied by $149.66), subject to area wage adjustment.
    Also in the CY 2019 HH PPS final rule (83 FR 56516), we finalized
our policy that the process for partial payment adjustments for 30-day
periods of care will remain the same as the process for 60-day
episodes. The partial episode payment (PEP) adjustment is a proportion
of the period payment and is based on the span of days including the
start-of-care date (for example, the date of the first billable
service) through and including the last billable service date under the
original plan of care before the intervening event in a home health
beneficiary's care defined as a--
     Beneficiary elected transfer, or
     Discharge and return to home health that would warrant,
for purposes of payment, a new OASIS assessment, physician
certification of eligibility, and a new plan of care.
    When a new 30-day period begins due to an intervening event, the
original 30-day period will be proportionally adjusted to reflect the
length of time the beneficiary remained under the agency's care prior
to the intervening event. The proportional payment is the partial
payment adjustment. The partial payment adjustment will be calculated
by using the span of days (first billable service date through and
including the last billable service date) under the original plan of
care as a proportion of the 30-day period. The proportion will then be
multiplied by the original case-mix and wage index to produce the 30-
day payment.
F. Proposed Payments for High-Cost Outliers Under the H PPS
1. Background
    Section 1895(b)(5) of the Act allows for the provision of an
addition or adjustment to the home health payment amount otherwise made
in the case of outliers because of unusual variations in the type or
amount of medically necessary care. Under the HH PPS, outlier payments
are made for episodes whose estimated costs exceed a threshold amount
for each Home Health Resource Group (HHRG). The episode's estimated
cost was established as the sum of the national wage-adjusted per-visit
payment amounts delivered during the episode. The outlier threshold for
each case-mix group or partial episode payment (PEP) adjustment is
defined as the 60-day episode payment or PEP adjustment for that group
plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS,
the FDL amount is calculated by multiplying the HH FDL ratio by a
case's wage-adjusted national, standardized 60-day episode payment
rate, which yields an FDL dollar amount for the case. The outlier
threshold amount is the sum of the wage and case-mix adjusted PPS
episode amount and wage-adjusted FDL amount. The outlier payment is
defined to be a proportion of the wage-adjusted estimated cost that
surpasses the wage-adjusted threshold. The proportion of additional
costs over the outlier threshold amount paid as outlier payments is
referred to as the loss-sharing ratio.
    As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through
70399), section 3131(b)(1) of the Affordable Care Act amended section
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH
PPS payment rates such that aggregate HH PPS payments were reduced by 5
percent. In addition, section 3131(b)(2) of the Affordable Care Act
amended section 1895(b)(5) of the Act by re-designating the existing
language as section 1895(b)(5)(A) of the Act and revising the language
to state that the total amount of the additional payments or payment
adjustments for outlier episodes could not exceed 2.5 percent of the
estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of
the Affordable Care Act also added section 1895(b)(5)(B) of the Act,
which capped outlier payments as a percent of total payments for each
HHA for each year at 10 percent.
    As such, beginning in CY 2011, we reduced payment rates by 5
percent and targeted up to 2.5 percent of total estimated HH PPS
payments to be paid as outliers. To do so, we first returned the 2.5
percent held for the target CY 2010 outlier pool to the national,
standardized 60-day episode rates, the national per visit rates, the
LUPA add-on payment amount, and the NRS conversion factor for CY 2010.
We then reduced the rates by 5 percent as
[[Page 34636]]
required by section 1895(b)(3)(C) of the Act, as amended by section
3131(b)(1) of the Affordable Care Act. For CY 2011 and subsequent
calendar years we targeted up to 2.5 percent of estimated total
payments to be paid as outlier payments, and apply a 10 percent agency-
level outlier cap.
    In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through
43742 and 81 FR 76702), we described our concerns regarding patterns
observed in home health outlier episodes. Specifically, we noted that
the methodology for calculating home health outlier payments may have
created a financial incentive for providers to increase the number of
visits during an episode of care in order to surpass the outlier
threshold; and simultaneously created a disincentive for providers to
treat medically complex beneficiaries who require fewer but longer
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR
76702), we finalized changes to the methodology used to calculate
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate
payment for outlier episodes, accounting for both the number of visits
during an episode of care and also the length of the visits provided.
Using this approach, we now convert the national per-visit rates into
per 15-minute unit rates. These per 15-minute unit rates are used to
calculate the estimated cost of an episode to determine whether the
claim will receive an outlier payment and the amount of payment for an
episode of care. In conjunction with our finalized policy to change to
a cost-per-unit approach to estimate episode costs and determine
whether an outlier episode should receive outlier payments, in the CY
2017 HH PPS final rule we also finalized the implementation of a cap on
the amount of time per day that would be counted toward the estimation
of an episode's costs for outlier calculation purposes (81 FR 76725).
Specifically, we limit the amount of time per day (summed across the
six disciplines of care) to 8 hours (32 units) per day when estimating
the cost of an episode for outlier calculation purposes.
    We plan to publish the cost-per-unit amounts for CY 2020 in the
rate update change request, which is issued after the publication of
the CY 2020 HH PPS final rule. We note that in the CY 2017 HH PPS final
rule (81 FR 76724), we stated that we did not plan to re-estimate the
average minutes per visit by discipline every year. Additionally, we
noted that the per-unit rates used to estimate an episode's cost will
be updated by the home health update percentage each year, meaning we
would start with the national per-visit amounts for the same calendar
year when calculating the cost-per-unit used to determine the cost of
an episode of care (81 FR 76727). We note that we will continue to
monitor the visit length by discipline as more recent data become
available, and we may propose to update the rates as needed in the
future.
    In the CY 2019 HH PPS final rule (83 FR 56521), we finalized a
policy to maintain the current methodology for payment of high-cost
outliers upon implementation of the PDGM beginning in CY 2020 and that
we will calculate payment for high-cost outliers based upon 30-day
periods of care. The calculation of the proposed fixed-dollar loss
ratio for CY 2020 for both the 60-day episodes that span the
implementation date, and for 30-day periods of care beginning on and
after January 1, 2020 is detailed in this section.
2. Proposed Fixed Dollar Loss (FDL) Ratio for CY 2020
    For a given level of outlier payments, there is a trade-off between
the values selected for the FDL ratio and the loss-sharing ratio. A
high FDL ratio reduces the number of episodes or periods that can
receive outlier payments, but makes it possible to select a higher
loss-sharing ratio, and therefore, increase outlier payments for
qualifying outlier episodes or periods. Alternatively, a lower FDL
ratio means that more episodes or periods can qualify for outlier
payments, but outlier payments per episode or per period must then be
lower.
    The FDL ratio and the loss-sharing ratio must be selected so that
the estimated total outlier payments do not exceed the 2.5 percent
aggregate level (as required by section 1895(b)(5)(A) of the Act).
Historically, we have used a value of 0.80 for the loss-sharing ratio
which, we believe, preserves incentives for agencies to attempt to
provide care efficiently for outlier cases. With a loss-sharing ratio
of 0.80, Medicare pays 80 percent of the additional estimated costs
that exceed the outlier threshold amount.
    In the CY 2019 HH PPS final rule (83 FR 56439), we finalized a FDL
ratio of 0.51 to pay up to, but no more than, 2.5 percent of total
payments as outlier payments. For CY 2020, we are not proposing to
update the FDL ratio for those 60-day episodes that span the
implementation date of the PDGM; we would keep the FDL ratio for 60-day
episodes in CY 2020 at 0.51. For this CY 2020 proposed rule, simulating
payments using preliminary CY 2018 claims data (as of January 2019) and
the CY 2019 HH PPS payment rates, we estimate that outlier payments in
CY 2019 would comprise 2.42 percent of total payments for those 60-day
episodes that span into 2020 and are paid under the national,
standardized 60-day payment rate (with an FDL of 0.51) and 2.5 percent
of total payments for PDGM 30-day periods using the 30-day budget-
neutral payment amount as detailed in section III.B. of this proposed
rule (with an FDL of 0.63). Given the statutory requirement that total
outlier payments not exceed 2.5 percent of the total payments estimated
to be made under the HH PPS, we are proposing that the FDL ratio for
30-day periods of care in CY 2020 would need to be set at 0.63 for 30-
day periods of care based on our simulations looking at both 60-day
episodes that would span into CY 2020 and 30-day periods. We note that
in the final rule, we will update our estimate of outlier payments as a
percent of total HH PPS payments using the most current and complete
year of HH PPS data (CY 2018 claims data as of June 30, 2019 or later)
and therefore, we may adjust the final FDL ratio accordingly. We invite
public comments on the proposed change to the FDL ratio for CY 2020.
G. Proposed Changes to the Split-Percentage Payment Approach for HHAs
in CY 2020 and Subsequent Years
1. Background
    In the current HH PPS, there is a split-percentage payment approach
to the 60-day episode of care. The first bill, a Request for
Anticipated Payment (RAP), is submitted at the beginning of the initial
episode for 60 percent of the anticipated final claim payment amount.
The second, final bill is submitted at the end of the 60-day episode
for the remaining 40 percent. For all subsequent episodes for
beneficiaries who receive continuous home health care, the episodes are
paid at a 50/50 percentage payment split. RAP submissions are
operationally significant, as the RAP establishes the beneficiary's
primary HHA by alerting the claims processing system consolidating
billing edits.
    In the CY 2018 HH PPS proposed rule (82 FR 35270), we solicited
comments as to whether the split-percentage payment approach would
still be needed for HHAs to maintain adequate cash flow if the unit of
payment changes from a 60-day episode to a 30-day period; ways to
phase-out the split-percentage payment approach, including reducing the
percentage of
[[Page 34637]]
upfront payment incrementally over a period of time; and if the split-
percentage payment approach was ultimately eliminated, whether
submission of a Notice of Admission (NOA) within 5 days of the start of
care would be needed to establish the primary HHA so the claims
processing system would be alerted to a home health period of care.
Commenters generally expressed support for continuing the split-
percentage payment approach in the future under the proposed
alternative case-mix model. While we solicited comments on the
possibility of phasing-out the split-percentage payment approach in the
future and the need for a NOA, commenters did not provide suggestions
for a phase-out approach, but stated that they did not agree with
requiring a NOA, given their experience with a similar process under
the Medicare hospice benefit. We did not finalize the change to a 30-
day unit of payment in the CY 2018 HH PPS final rule to allow CMS more
time to examine the effects of such change to a 30-day unit of payment
and to an alternate case-mix methodology.
    Section 1895(b)(2)(B) of the Act, as added by section 51001(a) of
the BBA of 2018, requires that CMS move to a 30-day payment period from
a 60-day payment period, effective January 1, 2020. As such, in the CY
2019 HH PPS proposed rule (83 FR 32391), we proposed a change to the
split-percentage payment approach where newly-enrolled HHAs, meaning
HHAs that were certified for participation in Medicare on or after
January 1, 2019, would not receive split-percentage payments beginning
in CY 2020. We also proposed that HHAs that are certified for
participation in Medicare effective on or after January 1, 2019, would
still be required to submit a ``no pay'' RAP at the beginning of care
in order to establish the home health period of care, as well as every
30 days thereafter. Additionally, we proposed that existing HHAs, that
is, HHAs certified for participation in Medicare effective prior to
January 1, 2019, would continue to receive split-percentage payments
upon implementation of the PDGM and the 30-day unit of payment in CY
2020. For split-percentage payments to be made, we proposed that
existing HHAs would have to submit a RAP at the beginning of each 30-
day period of care and a final claim would be submitted at the end of
each 30-day period of care. For the first 30-day period of care, we
proposed that the split-percentage payment would be 60/40 and all
subsequent 30-day periods of care would be a split-percentage payment
of 50/50.
    Many commenters supported all or parts of the split-percentage
payment proposals. Some commenters stated that elimination of the
split-percentage payments would align better with a 30-day payment and
would simplify home health claims submissions. Other commenters
generally expressed support for continuing the split-percentage payment
approach under the PDGM and disagreed with any future phase-out because
of a potential impact on cash flow. Others supported eventual
elimination of split-percentage payments but wanted ample time to adapt
to the PDGM and suggested a multi-year phase-out approach. Some
commenters supported elimination of split-percentage payments for late
periods of care but suggested that the split-percentage payments should
continue for early periods to ensure an upfront payment for newly
admitted home health patients. Ultimately, we finalized all of the
split-percentage payments proposals in the CY 2019 HH PPS final rule
(83 FR 56463), discussed previously.
2. CY 2019 HH PPS Final Rule Title Error Correction
    In the CY 2019 HH PPS final rule with comment (83 FR 56628), we
finalized that newly-enrolled HHAs, that is HHAs certified for
participation in Medicare effective on or after January 1, 2019, will
not receive split-percentage payments beginning in CY 2020. HHAs that
are certified for participation in Medicare effective on or after
January 1, 2019, will still be required to submit a ``no pay'' Request
for Anticipated Payment (RAP) at the beginning of a period of care in
order to establish the home health period of care, as well as every 30
days thereafter. Existing HHAs, meaning those HHAs that are certified
for participation in Medicare with effective dates prior to January 1,
2019, would continue to receive split-percentage payments upon
implementation of the PDGM and the change to a 30-day unit of payment
in CY 2020. We finalized the corresponding regulations text changes at
Sec.  484.205(g)(2), which sets forth the policy for split-percentage
payments for periods of care on or after January 1, 2020.
    However, after the final rule was published, we note that there was
an error in titling when the CY 2019 HH PPS final rule went to the
Federal Register. Specifically, paragraph (g)(2)(ii) is incorrectly
titled ``Split percentage payments on or after January 1, 2019''. The
title of this paragraph implies that split percentage payments are made
to newly-enrolled HHAs on or after January 1, 2019, which is
contradictory to the finalized policy on split percentage-payments for
newly enrolled HHAs beginning in CY 2020. As such, we are proposing to
make a correction to the regulations text at Sec.  484.205(g)(2)(iii)
to accurately reflect the finalized policy that newly-enrolled HHAs
will not receive split-percentage payments beginning in CY 2020. The
regulation at Sec.  484.205(g)(2)(iii), as it relates to split
percentage payments for newly-enrolled HHAs under the HH PPS beginning
in CY 2020, is separate from the placement of new HHAs into a
provisional period of enhanced oversight under the authority of section
6401(a)(3) of the Affordable Care Act, which amended section 1866(j)(3)
of the Act. The provisional period of enhanced oversight became
effective in February 2019. More information regarding the provisional
period of enhanced oversight can be found at the following link:
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19005.pdf
3. CY 2020 and Subsequent Years
    CMS continues to believe that, as a result of a reduced timeframe
for the unit of payment from a 60-day episode of care to a 30-day
period of care, a split-percentage payment approach may not be needed
for HHAs to maintain an adequate cash flow. We also believe that a one-
time submission of a NOA followed by home health claims submission on a
30-day basis may streamline claims processing for HHAs. Additionally,
our analysis has shown that approximately 5 percent of RAPs are not
submitted until the end of a 60-day episode of care, 10 percent of RAPs
are not submitted until 36 days after the start of the 60-day episode
of care, and the median length of days for RAP submission is 12 days
from the start of the 60-day episode of care (82 FR 35307). We believe
that these data are inconsistent with the stated justification for RAPs
maintaining adequate cash flow, especially given the change from a 60-
to 30-day unit of payment, and increases complexity for HHAs in their
claim submission processing. With the change to monthly billing in CY
2020, HHAs should have the ability to maintain an ongoing cash flow,
which we believe mitigates concerns for the continued need of a split-
percentage payment.
    We did not finalize any changes to RAP payments for existing HHAs
in the CY 2019 HH PPS final rule (83 FR 56462), we stated that we would
monitor RAP submissions, service
[[Page 34638]]
utilization, payment and quality trends which may change as a result of
implementing the PDGM and a 30-day unit of payment. We also stated if
changes in practice and/or coding patterns or RAPs submissions arise,
we may propose additional changes in policy.
    We have observed that RAP payments pose a significant program
integrity risk to the Medicare program, as the current RAP structure
pays HHAs 50 to 60 percent of the total episode payment upfront.
Currently, RAP payments are automatically recouped against other
payments if the claim for a given episode does not follow the RAP
submission in the later of: (1) 120 days from the start of the episode;
or (2) 60 days from the payment date of the RAP. As stated in the CY
2019 HH PPS proposed rule (83 FR 32391), some fraud schemes have
involved HHAs collecting RAP payments, never submitting final claims,
and ceasing business before CMS is aware of the need to take action.
    Under a typical RAP fraud scenario, a large amount of RAPs are
submitted in a short period of time, which could potentially result in
payments of millions of dollars within days of the submissions. The 60-
day or 120-day time period before a RAP cancellation is triggered in
the Fiscal Intermediary Standard System (FISS) is long enough to allow
a provider to continue to submit RAPs before we can identify that the
final claims are not being submitted and services are not being
rendered, and yet is too short for us to perform the necessary
investigative steps, such as medical reviews, site verifications, and
beneficiary interviews, to determine if fraudulent actions have been
conducted. The current payment regulations also allow discharges and
readmissions during a home health payment episode, which means that
some HHAs can submit multiple RAPs for the same provider/patient
combination during the same episode of care.
    This type of fraud scheme has been most prevalent among existing
providers. As a variation on this scheme, individuals with the intent
of perpetuating this fraud enter the Medicare program by acquiring
existing HHAs, allowing them to circumvent Medicare's screening and
enrollment process. For example, during the screening process, we deny
enrollment if owners listed on the enrollment form have certain
criminal backgrounds. However, some providers who acquire HHAs fail to
disclose ownership changes and as a result, the newly purchased HHA is
not subject to the normal enrollment screening process leaving us blind
to potentially problematic criminal histories. There are cases where we
would have denied enrollment based on a new owner's prior criminal
background, but we approve the enrollment of the purchasing entity due
to the intentional omission of the new owner and his criminal history.
More specifically, individuals intent on perpetrating the HH RAP fraud
have taken advantage of the acquisition of existing agencies through
Changes of Ownership (CHOWs) and Changes of Information, failing to
disclose ownership changes for those HH entities to CMS. A CHOW results
in the transfer of a previous owner's Medicare Identification Number
and provider agreement (including the previous owner's outstanding
Medicare debts) to a new owner and must be reported within 30 days. A
Change of Information must be submitted for various types of changes of
information on an enrollment. For instance, a change in ownership other
than a CHOW--such as the sale of stock from one of several 5 percent or
more owners, who is no longer an owner, to a new individual who has
become a 5 percent or more owner--also must be reported within 30 days
of the change (see Sec.  424.516(e)). Based on our investigations,
individuals perpetrating the RAP fraud fail to disclose ownership or
informational changes, which results in the changes not being reflected
in the Provider Enrollment, Chain, and Ownership System (PECOS), the
online Medicare provider and suppler enrollment system that allows
registered users to securely and electronically submit and manage
Medicare enrollment information. The lack of information concerning
changes in ownership contributes to the perpetuation of HH RAP fraud.
    CMS has monitored numerous schemes like this where an existing HHA
undergoes an unreported ownership change and CMS identifies a massive
spike in RAP submissions with no final claims ever being submitted.
These types of RAP fraud cases are difficult to investigate because the
actual owners perpetrating the fraud are often not the owners
identified in PECOS due to a failure to disclose ownership changes.
This complicates investigations and results in the need for additional
resources to perform extensive manual research of Secretary of States'
(SOS) and licensing agencies' websites. In several cases, the
individuals perpetrating the fraud have been found to be located
outside the country.
    The following are examples of HHAs that were identified for billing
large amounts of RAPs after a CHOW, or the acquisition of an existing
agency, from 2014 to the present.
     Example 1: One prior investigation illustrates an
individual intent on perpetrating the HH RAP fraud who took advantage
of the acquisition of an existing agency. The investigation was
initiated based on a lead generated by the Fraud Prevention System
(FPS). Per PECOS, the provider had an effective date that was followed
by a CHOW. The investigation was aided by a whistleblower coming
forward who stated that the new owners of the agency completed the
transaction with the intent to submit large quantities of fraudulent
claims with the expressed purpose of receiving inappropriate payment
from Medicare. Notwithstanding the quick actions taken to prevent
further inappropriate payments, the fraud scheme resulted in improper
payments of RAPs and final claims in the amount of $1.3 million.
     Example 2: One investigation, CY 2019 HH PPS proposed rule
(83 FR 32391), involved a HHA located in Michigan that submitted home
health claims for beneficiaries located in California and Florida.
Further analysis found that after a CHOW the HHA submitted RAPs with no
final claims. CMS discovered that the address of record for the HHA was
vacant for an extended period of time. In addition, we determined that
although the HHA had continued billing and receiving payments for RAP
claims, it had not submitted a final claim in 10 months. Ultimately,
the HHA submitted a total of $50,234,430 in RAP claims and received
$37,204,558 in RAP payments.
     Example 3: A HHA submitted a significant spike in the
number of RAPs following an ownership change. The investigation
identified that in the period following the CHOW there were RAP
payments totaling $12 million and thousands of RAPs that were submitted
for which apparently no services were rendered.
     Example 4: An Illinois HHA was identified through analysis
of CHOW information. Three months after, the HHA had a CHOW, the
provider submitted a spike in RAP suppressions. All payments to the
provider were suspended. Notwithstanding, the provider was paid $3.6
million in RAPs.
    We have attempted to address these types of vulnerabilities through
extensive monitoring and investigations. However, there continues to be
cases of individual HHAs causing large RAP fraud losses.
    In the CY 2019 HH PPS final rule (83 FR 56462), we stated our plan
to continue to closely monitor RAP submissions, service utilization,
[[Page 34639]]
payment, and quality trends which may change as a result of
implementing of the PDGM and a 30-day unit of payment in order to
address unusual billing patterns and potential fraud related to RAP
payments to existing providers. In light of the issues outlined in this
section, we have determined that the program integrity concerns based
upon the current RAP structure are significant enough to revisit the
continued need for RAP payments for existing HHAs and propose a phase-
out approach to RAP payments.
    Therefore, we are proposing a reduction of the split-percentage
payment in CY 2020 for existing HHAs and elimination of split-
percentage payments for all providers in CY 2021, along with
corresponding regulations text changes at Sec.  484.205. Specifically,
we are proposing, for existing HHAs (that is, HHAs certified for
participation in Medicare with effective dates prior to January 1,
2019): (1) To reduce the split-percentage payment from the current 60/
50 percent (dependent on whether the RAP is for a new or subsequent
period of care) to 20 percent in CY 2020 for all 30-day HH periods of
care (both initial and subsequent periods of care); and (2) full
elimination of the split-percentage payments for all providers in CY
2021. We believe that the proposed phase-out approach of split-
percentage payments with a reduction to a 20 percent split-percentage
payment in CY 2020 allows HHAs time to adjust to a no-RAP environment
and provides sufficient time for software and business process changes
for a CY 2021 implementation. The current split-percentage payments are
60/40 (for initial episodes of care) and 50/50 (for subsequent episodes
of care); therefore, we believe that the reduction in the split-
percentage payment must be sufficient enough in order to mitigate the
perpetuation of fraud schemes. As such, we believe a reduction to the
split percentage payment to 20 percent would achieve this purpose.
However, the 20 percent split percentage payment would still provide
some upfront payment as HHAs transition from receiving split-percentage
payments to receiving full payments on a 30-day basis.
    Additionally, we are proposing that newly enrolled HHAs, that is,
HHAs enrolled in Medicare on or after January 1, 2019 (and would not
receive split-percentage payments beginning in CY 2020), would continue
to submit ``no-pay'' RAPs at the beginning of every 30-day period in CY
2020. Beginning in CY 2021, we are proposing that all HHAs would
receive the full 30-day period of care payment once the final claim is
submitted to CMS.
    Beginning in CY 2021, we are also proposing that all HHAs submit a
one-time submission of a NOA within 5 calendar days of the start of
care to establish that the beneficiary is under a Medicare home health
period of care. The NOA would be used to trigger HH consolidated
billing edits, required by law under section 1842(b)(6)(F) of the Act,
and would allow for other providers and the CMS claims processing
systems to know that the beneficiary is in a HH period of care. We are
proposing that the NOA be submitted only at the beginning of the first
30-day period of care (that is, the NOA would not have to be submitted
for each subsequent 30-day period of care) to establish that the
beneficiary is under a home health period of care. However, if there is
any beneficiary discharge from home health services and subsequent
readmission, a new NOA would need to be submitted within 5 calendar
days of an initial 30-day period of care.
    When we solicited comments in the CY 2019 HH PPS proposed rule (83
FR 32390) on requiring HHAs to submit a NOA within 5 days of the start
of care if the split-percentage payment approach was eliminated,
commenters stated that they did not agree with requiring a NOA given
the experience with a similar Notice of Election (NOE) process under
the Medicare hospice benefit where there were submission issues causing
untimely filed NOEs. However, implementation of the Electronic Data
Interchange (EDI) submission of hospice Notices of Election (NOE) in
January 2018 has alleviated the issues related to the submission of the
hospice NOE by increasing efficiency and information exchange
coordination. As such, we are proposing that the home health NOA
process would be through an EDI submission, similar to that used for
submission of the hospice NOE. An EDI submission occurs when NOEs or
NOAs are submitted through an electronic data interchange for the
purpose of minimizing data entry errors. Because there is already a
Medicare claims processing notification of a benefit admission process
in place, we believe that this should make the home health NOA process
more consistent and timely for HHAs.
    Furthermore, because of the reduced timeframe for the unit of
payment from a 60-day episode of care to a 30-day period of care and
the proposed elimination of RAPs, NOAs would be needed for home health
period of care identification (83 FR 32390). Without such notification
triggering the home health consolidated billing edits establishing the
home health period of care in the common working file (CWF), there
could be an increase in claims denials. Subsequently, this potentially
could result in an increase in appeals and an increase in situations
where other providers, including other HHAs, would not have easily
accessible information on whether a patient was already being treated
by another HHA. In the CY 2019 HH PPS final rule, while some commenters
expressed their concern about potential submission issues and claims
delays which could result from the potential use of a NOA, one national
association was in support of such proposal. The association strongly
recommended CMS require HHAs to submit a NOA within 5 calendar days
from the start of care to ensure that the proper agency is established
as the primary HHA for the beneficiary and so that the claims
processing system is alerted that a beneficiary is under an HHA period
of care to enforce the consolidated billing edits required by law.
    We are proposing that failure to submit a timely NOA would result
in a reduction to the 30-day Medicare payment amount, from the start of
care date to the NOA filing date, as is done similarly in hospice. As
hospice is paid a bundled per diem payment amount for each day a
beneficiary is under a hospice election, Medicare will not cover and
pay for the days of hospice care from the hospice admission date to the
date the NOE is submitted to the Medicare contractor. Therefore, we are
proposing that the penalty for not submitting a timely home health NOA
would result in Medicare not paying for those days of home health
services from the start of care date to the NOA filing date.
    Since payment under home health is a bundled payment, which
includes a national, standardized 30-day period payment rate adjusted
for case-mix and geographic wage differences, we are proposing that the
payment reduction would be applied to the case-mix and wage-adjusted
30-day period payment amount, including NRS. As such, we are proposing
that the penalty for not submitting a timely NOA would be a 1/30
reduction off of the full 30-day period payment amount for each day
until the date the NOA is submitted (that is, from the start of care
date through the day before the NOA is submitted, as the day of
submission would be a covered day). The reduction (R) to the full 30-
day period payment amount would be calculated as follows:
[[Page 34640]]
     The number of days (d) from the start of care until the
NOA is submitted divided by 30 days;
     The fraction from step 1 is multiplied by the case-mix and
wage adjusted 30-day period payment amount (P).
    The formula for the reduction would be R = (d/30) x P.
There would be no NOA penalty if the NOA is submitted timely (that is,
within the first 5 calendar days starting with the start of care date).
Likewise, we propose that for periods of care in which an HHA fails to
submit a timely NOA, no LUPA payments would be made for days that fall
within the period of care prior to the submission of the NOA. We are
proposing that these days would be a provider liability, the payment
reduction could not exceed the total payment of the claim, and that the
provider may not bill the beneficiary for these days. Once the NOA is
received, all claims for both initial and subsequent episodes of care
would compare the receipt date of the NOA to the HH period of care
start date to determine whether a late NOA reduction applies.
    However, we are also proposing that if an exceptional circumstance
is experienced by the HHA, CMS may waive the consequences of failure to
submit a timely-filed NOA. For instance, if a HHA requests a waiver of
the payment consequences due to an exceptional circumstance, the home
health agency would fully document and furnish any requested
documentation to CMS, through their corresponding MAC, for a
determination of exception. We are proposing that these exceptional
circumstances would be the same as those in place for the hospice NOE.
That is, we are proposing that an exceptional circumstance for such
waiver would be, but is not limited to the following:
     Fires, floods, earthquakes, or similar unusual events that
inflict extensive damage to the home health agency's ability to
operate.
     A CMS or Medicare contractor systems issue that is beyond
the control of the home health agency.
     A newly Medicare-certified home health agency that is
notified of that certification after the Medicare certification date,
or which is awaiting its user ID from its Medicare contractor.
     Other situations determined by CMS to not be under the
control of the home health agency.
    We are soliciting comments on our proposals to phase-out the split
percentage payments beginning in CY 2020 with the elimination of split-
percentage payments in CY 2021 for existing HHAs (that is, those HHAs
certified to participate in Medicare prior to January 1, 2019). We note
that in the CY 2019 HH PPS final rule (83 FR 56463), we finalized that
HHAs certified for participation in Medicare on and after January 1,
2019, would not receive split percentage payments beginning in CY 2020.
We are also soliciting comments on the implementation of a NOA process,
including the NOA timely-filing requirement, for all HHAs, in CY 2021
and subsequent years; and the corresponding regulation text changes at
Sec.  484.205.
H. Proposed Regulatory Change To Allow Therapist Assistants To Perform
Maintenance Therapy
    As referenced in our regulations at Sec.  409.44(c)(2)(iii), in
order for therapy visits to be covered in the home health setting one
of three criteria must be met: There must be an expectation that the
beneficiary's condition will improve materially in a reasonable (and
generally predictable) period of time based on the physician's
assessment of the beneficiary's restoration potential and unique
medical condition; the unique clinical condition of a patient requires
the specialized skills, knowledge, and judgment of a qualified
therapist to design or establish a safe and effective maintenance
program required in connection with the patient's specific illness or
injury; or the unique clinical condition of a patient requires the
specialized skills of a qualified therapist to perform a safe and
effective maintenance program required in connection with the patient's
specific illness or injury. The regulations at Sec.
409.44(c)(2)(iii)(C) state that where the clinical condition of the
patient is such that the complexity of the therapy services required to
maintain function involves the use of complex and sophisticated therapy
procedures to be delivered by the therapist himself/herself (and not an
assistant) or the clinical condition of the patient is such that the
complexity of the therapy services required to maintain function must
be delivered by the therapist himself/herself (and not an assistant) in
order to ensure the patient's safety and to provide an effective
maintenance program, then those reasonable and necessary services shall
be covered.
    In contrast to restorative therapy, provided when the goals of care
are geared towards patient improvement, maintenance therapy is provided
when improvement is not feasible in order to prevent or slow further
decline/deterioration of the patient's condition. While a therapist
assistant is able to perform restorative therapy under the Medicare
home health benefit, the regulations at Sec.  409.44(c)(2)(iii)(C)
state that only a qualified therapist, and not an assistant, can
perform maintenance therapy. Of note, the CY 2011 HH PPS final rule (75
FR 70372) reorganized the text regarding this regulation, but did not
re-evaluate the policy.
    The regulations at Sec.  484.115(g) and (i) state that qualified
occupational and physical therapist assistants are licensed as
assistants unless licensure does not apply, are registered or
certified, if applicable, as assistants by the state in which
practicing, and have graduated from an approved curriculum for
therapist assistants, and passed a national examination for therapist
assistants. In states where licensure does not apply, therapist
assistants must meet certain education and/or proficiency examination
requirements. For example, physical therapist assistants (PTAs) in
general, practice in accordance with physical therapy state practice
acts, providing many of the services that a physical therapist (PT)
provides, such as therapeutic exercise, mobilization, and passive
manipulation.\15\ Services must be commensurate with the PTA's
education, training, and experience, and must be under the direction of
a supervising PT. Additionally, Medicare allows services furnished by
therapist assistants to be included as part of the covered services
under a benefit when provided under the direction and supervision of a
qualified therapist.\16\ The regulations at Sec.  409.44(c) set out the
skilled service requirements for physical therapy, speech-language
pathology services, and occupational therapy under the home health
benefit. In accordance with Sec.  409.44(c)(1)(i), a patient must be
under a physician plan of care with documented therapy goals
established by a qualified therapist in conjunction with the physician.
Additionally, in accordance with Sec.  409.44(c)(2)(i)(A) and (B), the
patient's function must be initially assessed and reassessed at least
every 30 calendar days by a qualified therapist. As such, under the
Medicare home health benefit, a therapist assistant can furnish
services covered under a home health plan of care, when provided under
the direction and supervision of a qualified therapist, responsible for
establishing the plan of care and assessing and reassessing the
patient.
---------------------------------------------------------------------------
    \15\ https://www.laptboard.org/index.cfm/rules/practiceact.
    \16\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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[[Page 34641]]
    While Medicare allows for skilled maintenance therapy in a SNF, HH,
and other outpatient settings, the type of clinician that can provide
the therapy services vary by setting. In some settings both the
therapist and the therapist assistant can deliver the skilled
maintenance therapy services, and in other settings, only the therapist
can deliver the skilled maintenance therapy services. For example,
Medicare regulations allow therapist assistants to provide maintenance
therapy in a SNF, but not in the home health setting. Furthermore,
commenters on the CY 2019 Physician Fee Schedule final rule (83 FR
59654) noted concerns about shortages of therapists and finalized
payment for outpatient therapy services for which payment is made for
services that are furnished by a therapist assistant. As such, this
rule recognizes that therapist assistants play a valuable role in the
provision of needed therapy services.
    We believe it would be appropriate to allow therapist assistants to
perform maintenance therapy services under a maintenance program
established by a qualified therapist under the home health benefit, if
acting within the therapy scope of practice defined by state licensure
laws. The qualified therapist would still be responsible for the
initial assessment; plan of care; maintenance program development and
modifications; and reassessment every 30 days, in addition to
supervising the services provided by the therapist assistant. We
believe this would allow home health agencies more latitude in resource
utilization. Furthermore, allowing assistants to perform maintenance
therapy would be consistent with other post-acute care settings,
including SNFs. Thus, we are proposing to modify the regulations at
Sec.  409.44(c)(2)(iii)(C) to allow therapist assistants (rather than
only therapists) to perform maintenance therapy under the Medicare home
health benefit. We are soliciting comments regarding this proposal and
we also welcome feedback on whether this proposal would require
therapists to provide more frequent patient reassessment or maintenance
program review when the services are being performed by a therapist
assistant. We are also soliciting comments on whether we should revise
the description of the therapy codes to indicate maintenance services
performed by a physical or occupational therapist assistant (G0151 and
G0157) versus a qualified therapist, or simply remove the therapy code
indicating the establishment or delivery of a safe and effective
physical therapy maintenance program, by a physical therapist (G0159).
We welcome comments on the importance of tracking whether a visit is
for maintenance or restorative therapy or whether it would be
appropriate to only identify whether the service is furnished by a
qualified therapist or an assistant. Finally, we seek comments on any
possible effects on the quality of care that could result by allowing
therapist assistants to perform maintenance therapy.
I. Proposed Changes to the Home Health Plan of Care Regulations at
Sec.  409.43
    As a condition for payment of Medicare home health services, the
regulations at Sec.  409.43(a), home health plan of care content
requirements, state that the plan of care must contain those items
listed in Sec.  484.60(a) that specify the standards relating to a plan
of care that an HHA must meet in order to participate in the Medicare
program. The home health conditions of participation (CoPs) at Sec.
484.60(a) set forth the content requirements of the individualized home
health plan of care. In the January 13, 2017 final rule, ``Medicare and
Medicaid Program: Conditions of Participation for Home Health
Agencies'' (82 FR 4504), we finalized changes to the plan of care
requirements under the home health CoPs by reorganizing the existing
plan of care content requirements at Sec.  484.18(a), adding two
additional plan of care content requirements, and moving the plan of
care content requirements to Sec.  484.60(a). Specifically, in addition
to the longstanding plan of care content requirements previously listed
at Sec.  484.18(a), a home health plan of care must also include the
following:
     A description of the patient's risk for emergency
department visits and hospital readmission, and all necessary
interventions to address the underlying risk factors; and
     Information related to any advanced directives.
    The new content requirements for the plan of care at Sec.
484.60(a) became effective January 13, 2018 (82 FR 31729) and the
Interpretive Guidelines to accompany the new CoPs were released on
August 31, 2018. Since implementation of the new home health CoP plan
of care requirements, we clarified in subregulatory guidance in the
Medicare Benefit Policy Manual, chapter 7,\17\ that the plan of care
must include the identification of the responsible discipline(s)
providing home health services, and the frequency and duration of all
visits, as well as those items required by the CoPs that establish the
need for such services (Sec.  484.60(a)(2)(iii) and (iv)).
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    \17\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
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    However, the current requirements at Sec.  409.43(a) may be overly
prescriptive and may interfere with timely payment for otherwise
eligible episodes of care. To mitigate these potential issues, we are
proposing to change the regulations text at Sec.  409.43(a).
Specifically, we are proposing to change the regulations text to state
that for HHA services to be covered, the individualized plan of care
must specify the services necessary to meet the patient-specific needs
identified in the comprehensive assessment. In addition, the plan of
care must include the identification of the responsible discipline(s)
and the frequency and duration of all visits as well as those items
listed in 42 CFR 484.60(a) that establish the need for such services.
All care provided must be in accordance with the plan of care. While
these newly-added plan of care items at Sec.  484.60(a) remain CoP, we
believe that violations for missing required items are best addressed
through the survey process, rather than through claims denials for
otherwise eligible periods of care. We are soliciting comments on this
proposal to change to the regulations text at Sec.  409.43 to state
that the home health plan of care must include those items listed in 42
CFR 484.60(a) that establish the need for such services.
IV. Proposed Provisions of the Home Health Value-Based Purchasing
(HHVBP) Model
A. Background
    As authorized by section 1115A of the Act and finalized in the CY
2016 HH PPS final rule (80 FR 68624) and in the regulations at 42 CFR
part 484, subpart F, we began testing the HHVBP Model on January 1,
2016. The HHVBP Model has an overall purpose of improving the quality
and delivery of home health care services to Medicare beneficiaries.
The specific goals of the Model are to: (1) Provide incentives for
better quality care with greater efficiency; (2) study new potential
quality and efficiency measures for appropriateness in the home health
setting; and (3) enhance the current public reporting process.
    Using the randomized selection methodology finalized in the CY 2016
HH PPS final rule, we selected nine states for inclusion in the HHVBP
Model, representing each geographic area across the nation. All
Medicare-certified Home Health Agencies (HHAs) providing services in
Arizona, Florida,
[[Page 34642]]
Iowa, Maryland, Massachusetts, Nebraska, North Carolina, Tennessee, and
Washington are required to compete in the Model. The HHVBP Model uses
the waiver authority under section 1115A(d)(1) of the Act to adjust
Medicare payment rates under section 1895(b) of the Act based on the
competing HHAs' performance on applicable measures. The maximum payment
adjustment percentage increases incrementally, upward or downward, over
the course of the HHVBP Model in the following manner: (1) 3 percent in
CY 2018; (2) 5 percent in CY 2019; (3) 6 percent in CY 2020; (4) 7
percent in CY 2021; and (5) 8 percent in CY 2022. Payment adjustments
are based on each HHA's Total Performance Score (TPS) in a given
performance year (PY), which is comprised of performance on: (1) A set
of measures already reported via the Outcome and Assessment Information
Set (OASIS), completed Home Health Consumer Assessment of Healthcare
Providers and Systems (HHCAHPS) surveys, and select claims data
elements; and (2) three New Measures for which points are achieved for
reporting data.
    In the CY 2017 HH PPS final rule (81 FR 76741 through 76752), CY
2018 HH PPS final rule (83 FR 51701 through 51706), and CY 2019 HH PPS
final rule (83 FR 56527 through 56547), we finalized changes to the
HHVBP Model. Some of those changes included adding and removing
measures from the applicable measure set, revising our methodology for
calculating benchmarks and achievement thresholds at the state level,
creating an appeals process for recalculation requests, and revising
our methodologies for weighting measures and assigning improvement
points.
B. Public Reporting of Total Performance Scores and Percentile Rankings
Under the HHVBP Model
    As stated previously and discussed in prior rulemaking, one of the
goals of the HHVBP Model is to enhance the current public reporting
processes for home health. In the CY 2016 HH PPS final rule, we
finalized our proposed reporting framework for the HHVBP Model,
including both the annual and quarterly reports that are made available
to competing HHAs and a separate, publicly available quality report (80
FR 68663 through 68665). We stated that such publicly available
performance reports would inform home health industry stakeholders
(consumers, physicians, hospitals) as well as all competing HHAs
delivering care to Medicare beneficiaries within selected state
boundaries on their level of quality relative to both their peers and
their own past performance, and would also provide an opportunity to
confirm that the beneficiaries referred for home health services are
being provided the best quality of care available. We further stated
that we intended to make public competing HHAs' TPSs with the intention
of encouraging providers and other stakeholders to utilize quality
ranking when selecting an HHA. As summarized in the CY 2016 final rule
(80 FR 68665), overall, commenters generally encouraged the
transparency of data pertaining to the HHVBP Model. Commenters offered
that to the extent possible, accurate comparable data would provide
HHAs the ability to improve care delivery and patient outcomes, while
better predicting and managing quality performance and payment updates.
    We have continued to discuss and solicit comments on the scope of
public reporting under the HHVBP Model in subsequent rulemaking. In the
CY 2017 final rule (81 FR 76751 through 76752), we discussed the public
display of total performance scores, stating that annual publicly
available performance reports would be a means of developing greater
transparency of Medicare data on quality and aligning the competitive
forces within the market to deliver care based on value over volume. We
stated our belief that the public reporting of competing HHAs'
performance scores under the HHVBP Model would support our continued
efforts to empower consumers by providing more information to help them
make health care decisions, while also encouraging providers to strive
for higher levels of quality. We explained that we have employed a
variety of means (CMS Open Door Forums, webinars, a dedicated help
desk, and a web-based forum where training and learning resources are
regularly posted) to facilitate direct communication, sharing of
information and collaboration to ensure that we maintain transparency
while developing and implementing the HHVBP Model. This same care was
taken with our plans to publicly report performance data, through
collaboration with other CMS components that use many of the same
quality measures. We also noted that section 1895(b)(3)(B)(v) of the
Act requires HHAs to submit patient-level quality of care data using
the OASIS and the HHCAHPS, and that section 1895(b)(3)(B)(v)(III) of
the Act states that this quality data is to be made available to the
public. Thus, HHAs have been required to collect OASIS data since 1999
and report HHCAHPS data since 2012.
    We solicited further public comment in the CY 2019 HH PPS proposed
rule (83 FR 32438) on which information from the Annual Total
Performance Score and Payment Adjustment Report (Annual Report) should
be made publicly available. We noted that HHAs have the opportunity to
review and appeal their Annual Report as outlined in the appeals
process finalized in the CY 2017 HH PPS final rule (81 FR 76747 through
76750). Examples of the information included in the Annual Report are
the agency name, address, TPS, payment adjustment percentage,
performance information for each measure used in the Model (for
example, quality measure scores, achievement, and improvement points),
state and cohort information, and percentile ranking. We stated that
based on the public comments received, we would consider what
information, specifically from the Annual Report, we may consider
proposing for public reporting in future rulemaking.
    As we summarized in the CY 2019 HH PPS final rule (83 FR 56546
through 56547), several commenters expressed support for publicly
reporting information from the Annual Total Performance Score and
Payment Adjustment Report, as they believed it would better inform
consumers and allow for more meaningful and objective comparisons among
HHAs. Other commenters suggested that CMS consider providing the
percentile ranking for HHAs along with their TPS and expressed interest
in publicly reporting all information relevant to the HHVBP Model.
Several commenters expressed concern with publicly displaying HHAs'
TPSs, citing that the methodology is still evolving and pointing out
that consumers already have access to data on the quality measures in
the Model on Home Health Compare. Another commenter believed that
publicly reporting data just for states included in the HHVBP Model
could be confusing for consumers.
    Our belief remains that publicly reporting HHVBP data would enhance
the current home health public reporting processes as it would better
inform beneficiaries when choosing an HHA, while incentivizing HHAs to
improve quality. Although the data made public would only pertain to
the final performance year of the Model, we believe that publicly
reporting HHVBP data for Performance Year 5 would nonetheless
incentivize HHAs to improve performance. Consistent with our discussion
in prior rulemaking of the information that we are considering
[[Page 34643]]
for public reporting under the HHVBP Model, we propose to publicly
report, on the CMS website the following two points of data from the
final CY 2020 (PY) 5 Annual Report for each participating HHA in the
Model that qualified for a payment adjustment for CY 2020: (1) The
HHA's TPS from PY 5, and (2) the HHA's corresponding PY 5 TPS
Percentile Ranking. We are considering making these data available on
the HHVBP Model page of the CMS Innovation website (https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model). These data would be reported for each such competing HHA by
agency name, city, state, and by the agency's CMS Certification Number
(CCN). We expect that these data would be made public after December 1,
2021, the date by which we intend to complete the CY 2020 Annual Report
appeals process and issuance of the final Annual Report to each HHA.
    As discussed in prior rulemaking, we believe the public reporting
of such data would further enhance quality reporting under the Model by
encouraging participating HHAs to provide better quality of care
through focusing on quality improvement efforts that could potentially
improve their TPS. In addition, we believe that publicly reporting
performance data that indicates overall performance may assist
beneficiaries, physicians, discharge planners, and other referral
sources in choosing higher-performing HHAs within the nine Model states
and allow for more meaningful and objective comparisons among HHAs on
their level of quality relative to their peers.
    We believe that the TPS would be more meaningful if the
corresponding TPS Percentile Ranking were provided so consumers can
more easily assess an HHA's relative performance. We would also provide
definitions for the HHVBP TPS and the TPS Percentile Ranking
methodology to ensure the public understands the relevance of these
data points and how they were calculated.
    Under our proposal, the data reported would be limited to one year
of the Model. We believe this proposal strikes a balance between
allowing for public reporting under the Model for the reasons discussed
while heeding commenters' concerns about reporting performance data for
earlier performance years of the HHVBP Model. We believe publicly
reporting the TPS and TPS Percentile Ranking for CY 2020 would enhance
quality reporting under the Model by encouraging participating HHAs to
provide better quality of care and would promote transparency, and
could enable beneficiaries to make better informed decisions about
where to receive care.
    We are soliciting comment on our proposal to publicly report the
Total Performance Score and Total Performance Score Percentile Ranking
from the final CY 2020 PY 5 Annual Report for each HHA in the nine
Model states that qualified for a payment adjustment for CY 2020. We
are also soliciting comment on our proposed amendment to Sec.  484.315
to reflect this policy. Specifically, we are proposing to add new
paragraph (d) to specify that CMS will report, for performance year 5,
the TPS and the percentile ranking of the TPS for each competing HHA on
the CMS website.
C. CMS Proposal To Remove Improvement in Pain Interfering With Activity
Measure (NQF #0177)
    As discussed in section V.C. of this proposed rule, CMS is
proposing to remove the Improvement in Pain Interfering with Activity
Measure (NQF #0177) from the Home Health Quality Reporting Program (HH
QRP) beginning with CY 2022. Under this proposal, HHAs would no longer
be required to submit OASIS Item M1242, Frequency of Pain Interfering
with Patient's Activity or Movement, for the purposes of the HH QRP
beginning January 1, 2021. As HHAs would continue to be required to
submit their data for this measure through CY 2020, we do not
anticipate any impact on the collection of this data and the inclusion
of the measure in the HHVBP Model's applicable measure set for the
final performance year (CY 2020) of the Model.
V. Proposed Updates to the Home Health Care Quality Reporting Program
(HH QRP)
A. Background and Statutory Authority
    The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act.
Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and
subsequent years, each HHA submit to the Secretary in a form and
manner, and at a time, specified by the Secretary, such data that the
Secretary determines are appropriate for the measurement of health care
quality. To the extent that an HHA does not submit data in accordance
with this clause, the Secretary shall reduce the home health market
basket percentage increase applicable to the HHA for such year by 2
percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act,
depending on the market basket percentage increase applicable for a
particular year, the reduction of that increase by 2 percentage points
for failure to comply with the requirements of the HH QRP and further
reduction of the increase by the productivity adjustment (except in
2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act
may result in the home health market basket percentage increase being
less than 0.0 percent for a year, and may result in payment rates under
the Home Health PPS for a year being less than payment rates for the
preceding year.
    For more information on the policies we have adopted for the HH
QRP, we refer readers to the CY 2007 HH PPS final rule (71 FR 65888
through 65891), the CY 2008 HH PPS final rule (72 FR 49861 through
49864), the CY 2009 HH PPS update notice (73 FR 65356), the CY 2010 HH
PPS final rule (74 FR 58096 through 58098), the CY 2011 HH PPS final
rule (75 FR 70400 through 70407), the CY 2012 HH PPS final rule (76 FR
68574), the CY 2013 HH PPS final rule (77 FR 67092), the CY 2014 HH PPS
final rule (78 FR 72297), the CY 2015 HH PPS final rule (79 FR 66073
through 66074), the CY 2016 HH PPS final rule (80 FR 68690 through
68695), the CY 2017 HH PPS final rule (81 FR 76752), the CY 2018 HH PPS
final rule (82 FR 51711 through 51712), and the CY 2019 HH PPS final
rule (83 FR 56547).
B. General Considerations Used for the Selection of Quality Measures
for the HH QRP
    For a detailed discussion of the considerations we historically use
for measure selection for the HH QRP quality, resource use, and others
measures, we refer readers to the CY 2016 HH PPS final rule (80 FR
68695 through 68696). In the CY 2019 HH PPS final rule (83 FR 56548
through 56550) we also finalized the factors we consider for removing
previously adopted HH QRP measures.
C. Quality Measures Currently Adopted for the CY 2021 HH QRP
    The HH QRP currently includes 19 \18\ measures for the CY 2021
program year, as outlined in Table 26.
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    \18\ The HHCAHPS has five component questions that together are
used to represent one NQF-endorsed measure.
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[[Page 34644]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.069
D. Proposed Removal of HH QRP Measures Beginning With the CY 2022 HH
QRP
    In line with our Meaningful Measures Initiative, we are proposing
to remove one measure from the HH QRP beginning with the CY 2022 HH
QRP.
1. Proposed Removal of the Improvement in Pain Activity Measure (NQF
#0177)
    We are removing pain-associated quality measures from its quality
reporting programs in an effort to mitigate any potential unintended,
over-prescription of opioid medications inadvertently driven by these
measures. We are proposing to remove the Improvement in Pain
Interfering with Activity Measure (NQF #0177) from the HH QRP beginning
with the CY 2022 HH QRP under our measure removal Factor 7: Collection
or public reporting of a measure leads to negative unintended
consequences other than patient harm.
    In the CY 2007 HH PPS final rule (71 FR 65888 through 65891), we
adopted the Improvement in Pain Interfering with Activity Measure
beginning with the CY 2007 HH QRP. The measure was NQF-endorsed (NQF
#0177) in March 2009. This risk-adjusted outcome measure reports the
percentage of HH episodes during which the patient's frequency of pain
with activity or movement improved. The measure is calculated using
OASIS Item M1242, Frequency of Pain Interfering with Patient's Activity
or Movement.\19\
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    \19\ Measure specifications can be found in the Home Health
Process Measures Table on the Home Health Quality Measures website
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Outcome-Measures-Table-OASIS-D-11-2018c.pdf.
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    We evaluated the Improvement in Pain Interfering with Activity
Measure (NQF #0177) and determined that the measure could have
unintended consequences with respect to responsible use of opioids for
the management of pain. In 2018, CMS published a comprehensive roadmap,
available at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Opioid-epidemic-roadmap.pdf, which outlined the
agency's efforts to address national issues around prescription opioid
misuse and overuse. Because the Medicare program pays for a significant
amount of prescription opioids, the roadmap was designed to promote
appropriate stewardship of these medications that can provide a medical
benefit but also carry a risk for patients, including those receiving
home health. One key component of this strategy is to prevent new cases
of opioid use disorder, through education, guidance and monitoring of
opioid prescriptions. When used correctly, prescription opioids are
helpful for treating pain. However, effective non-opioid pain
treatments are available to providers and CMS is working to promote
their use.
    Although we are not aware of any scientific studies that support an
association between the prior or current iterations of the Improvement
in Pain Interfering with Activity Measure (NQF #0177) and opioid
prescribing practices, out of an abundance of caution and to avoid any
potential unintended consequences, we are proposing to remove the
Improvement in Pain Interfering with Activity Measure (NQF #0177) from
the HH QRP beginning with the CY 2022 HH QRP under measure removal
Factor 7: Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm.
    If finalized as proposed, HHAs would no longer be required to
submit OASIS Item M1242, Frequency of Pain Interfering with Patient's
Activity or Movement for the purposes of this measure beginning January
1, 2021. We are unable to remove M1242 earlier due to the timelines
associated with implementing changes to OASIS. If finalized as
proposed, data for this
[[Page 34645]]
measure would be publicly reported on HH Compare until April 2020.
    We are inviting public comment on this proposal.
E. Proposed New and Modified HH QRP Quality Measures Beginning With the
CY 2022 HH QRP
    In this proposed rule, we are proposing to adopt two process
measures for the HH QRP under section 1895(b)(3)(B)(v)(IV)(aa) of the
Act, both of which would satisfy section 1899B(c)(1)(E)(ii) of the Act,
which requires that the quality measures specified by the Secretary
include measures with respect to the quality measure domain titled
``Accurately communicating the existence of and providing for the
transfer of health information and care preferences of an individual to
the individual, family caregiver of the individual, and providers of
services furnishing items and services to the individual, when the
individual transitions from a [post-acute care] PAC provider to another
applicable setting, including a different PAC provider, a hospital, a
critical access hospital, or the home of the individual.'' Given the
length of this domain title, hereafter, we will refer to this quality
measure domain as ``Transfer of Health Information.'' The two measures
we are proposing to adopt are: (1) Transfer of Health Information to
Provider-Post-Acute Care; and (2) Transfer of Health Information to
Patient-Post-Acute Care. Both of these proposed measures support our
Meaningful Measures priority of promoting effective communication and
coordination of care, specifically the Meaningful Measure area of the
transfer of health information and interoperability. One data element
in the Transfer of Health Information to Patient-Post-Acute Care
measure evaluates whether information was sent to the patient, family,
and caregiver at discharge.
    In addition to the two measure proposals, we are proposing to
update the specifications for the Discharge to Community-Post Acute
Care (PAC) HH QRP measure to exclude baseline nursing facility (NF)
residents from the measure.
1. Proposed Transfer of Health Information to the Provider-Post-Acute
Care (PAC) Measure
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) Measure is a process-based measure that assesses
whether or not a current reconciled medication list is given to the
admitting provider when a patient is discharged/transferred from his or
her current PAC setting.
(a) Background
    In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency, and 9 percent who were
discharged to SNFs.\20\ The proportion of patients being discharged
from an acute care hospital to a PAC setting was greater among
beneficiaries enrolled in Medicare fee-for-service (FFS), underscoring
the importance of the measure. Among Medicare FFS patients discharged
from an acute hospital, 42 percent went directly to PAC settings. Of
that 42 percent, 20 percent were discharged to a SNF, 18 percent were
discharged to an HHA, three percent were discharged to an IRF, and one
percent were discharged to an LTCH.\21\
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    \20\ Tian, W. ``An all-payer view of hospital discharge to post-
acute care,'' May 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \21\ Ibid.
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    The transfer and/or exchange of health information from one
provider to another can be done verbally (for example, clinician-to-
clinician communication in-person or by telephone), paper-based (for
example, faxed or printed copies of records), and via electronic
communication (for example, through a health information exchange
network using an electronic health/medical record, and/or secure
messaging). Health information, such as medication information, that is
incomplete or missing increases the likelihood of a patient or resident
safety risk, and is often life-threatening.22 23 24 25 26 27
Poor communication and coordination across health care settings
contributes to patient complications, hospital readmissions, emergency
department visits, and medication
errors.28 29 30 31 32 33 34 35 36 37 38 39 Communication has
been cited as the third most frequent root cause in sentinel events,
which The Joint Commission defines \40\ as a patient safety event that
results in death, permanent harm, or severe temporary harm. Failed or
ineffective patient handoffs are estimated to play a role in 20 percent
of serious preventable adverse events.\41\ When care transitions
[[Page 34646]]
are enhanced through care coordination activities, such as expedited
patient information flow, these activities can reduce duplication of
care services and costs of care, resolve conflicting care plans, and
prevent medical errors.42 43 44 45 46 47
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    \22\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
    \23\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
    \24\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \25\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
    \26\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
    \27\ Boling, P.A., ``Care transitions and home health care,''
Clinical Geriatric Medicine, 2009, Vol. 25(1), pp. 135-48.
    \28\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \29\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
    \30\ Jencks, S.F., Williams, M.V., & Coleman, E.A.,
``Rehospitalizations among patients in the Medicare fee-for-service
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp.
1418-1428.
    \31\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at: https://www.nap.edu/read/11623/chapter/1.
    \32\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \33\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \34\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at: https://www.nap.edu/read/11623/chapter/1.
    \35\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling approach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \36\ Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi, T.K., &
Bates, D.W., ``The incidence and severity of adverse events
affecting patients after discharge from the hospital.'' Annals of
Internal Medicine, 2003, 138(3), pp. 161-167.
    \37\ King, B.J., Gilmore[hyphen]Bykovskyi, A.L., Roiland, R.A.,
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of
poor communication during transitions from hospital to skilled
nursing facility: a qualitative study,'' Journal of the American
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
    \38\ Lattimer, C. (2011). When it comes to transitions in
patient care, effective communication can make all the difference.
Generations, 35(1), 69-72.
    \39\ Vognar, L., & Mujahid, N. (2015). Healthcare transitions of
older adults: an overview for the general practitioner. Rhode Island
Medical Journal (2013), 98(4), 15-18.
    \40\ The Joint Commission, ``Sentinel Event Policy'' available
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/.
    \41\ The Joint Commission. ``Sentinel Event Data Root Causes by
Event Type 2004-2015.'' 2016. Available at: https://www.jointcommission.org/assets/1/23/jconline_Mar_2_2016.pdf.
    \42\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \43\ Institute of Medicine, ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies
Press, 2007. Available at: https://www.nap.edu/read/11623/chapter/1.
    \44\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
    \45\ Pronovost, P., M.M.E. Johns, S. Palmer, R.C. Bono, D.B.
Fridsma, A. Gettinger, J. Goldman, W. Johnson, M. Karney, C. Samitt,
R.D. Sriram, A. Zenooz, and Y.C. Wang, Editors. Procuring
Interoperability: Achieving High-Quality, Connected, and Person-
Centered Care. Washington, DC, 2018 National Academy of Medicine.
Available at: https://nam.edu/wp-content/uploads/2018/10/Procuring-Interoperability_web.pdf.
    \46\ Balaban RB, Weissman JS, Samuel PA, & Woolhandler, S.,
``Redefining and redesigning hospital discharge to enhance patient
care: a randomized controlled study,'' J Gen Intern Med, 2008, Vol.
23(8), pp. 1228-33.
    \47\ Siefferman, J.W., Lin, E., & Fine, J.S. (2012). Patient
safety at handoff in rehabilitation medicine. Physical Medicine and
Rehabilitation Clinics of North America, 23(2), 241-257.
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    Care transitions across health care settings have been
characterized as complex, costly, and potentially hazardous, and may
increase the risk for multiple adverse outcomes.48 49 The
rising incidence of preventable adverse events, complications, and
hospital readmissions have drawn attention to the importance of the
timely transfer of health information and care preferences at the time
of transition. Failures of care coordination, including poor
communication of information, were estimated to cost the U.S. health
care system between $25 billion and $45 billion in wasteful spending in
2011.\50\ The communication of health information and patient care
preferences is critical to ensuring safe and effective transitions from
one health care setting to another.51 52
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    \48\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
    \49\ Simmons, S., Schnelle, J., Slagle, J., Sathe, N.A.,
Stevenson, D., Carlo, M., & McPheeters, M.L., ``Resident safety
practices in nursing home settings.'' Technical Brief No. 24
(Prepared by the Vanderbilt Evidence-based Practice Center under
Contract No. 290-2015-00003-I.) AHRQ Publication No. 16-EHC022-EF.
Rockville, MD: Agency for Healthcare Research and Quality. May 2016.
Available at: https://www.ncbi.nlm.nih.gov/books/NBK384624/.
    \50\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
    \51\ McDonald, K.M., Sundaram, V., Bravata, D.M., Lewis, R.,
Lin, N., Kraft, S.A. & Owens, D.K. Care Coordination. Vol. 7 of:
Shojania K.G., McDonald K.M., Wachter R.M., Owens D.K., editors.
``Closing the quality gap: A critical analysis of quality
improvement strategies.'' Technical Review 9 (Prepared by the
Stanford University-UCSF Evidence-based Practice Center under
contract 290-02-0017). AHRQ Publication No. 04(07)-0051-7.
Rockville, MD: Agency for Healthcare Research and Quality. June
2006. Available at: https://www.ncbi.nlm.nih.gov/books/NBK44015/.
    \52\ Lattimer, C., ``When it comes to transitions in patient
care, effective communication can make all the difference,''
Generations, 2011, Vol. 35(1), pp. 69-72.
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    Patients in PAC settings often have complicated medication regimens
and require efficient and effective communication and coordination of
care between settings, including detailed transfer of medication
information.53 54 55 Patients in PAC settings may be
vulnerable to adverse health outcomes due to insufficient medication
information on the part of their health care providers, and the higher
likelihood for multiple comorbid chronic conditions, polypharmacy, and
complicated transitions between care settings.56 57
Preventable adverse drug events (ADEs) may occur after hospital
discharge in a variety of settings including PAC.\58\ For older
patients discharged from the hospital, 80 percent of the medication
errors occurring during patient handoffs relate to miscommunication
between providers \59\ and for those transferring to an HHA, medication
errors typically relate to transmission of inaccurate discharge
medication lists.\60\ Medication errors and one-fifth of ADEs occur
during transitions between settings, including admission to or
discharge from a hospital to home or a PAC setting, or transfer between
hospitals.61 62
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    \53\ Starmer A.J, Spector N.D., Srivastava R., West, D.C.,
Rosenbluth, G., Allen, A.D., Noble, E.L., & Landrigen, C.P.,
``Changes in medical errors after implementation of a handoff
program,'' N Engl J Med, 2014, Vol. 37(1), pp. 1803-1812.
    \54\ Kruse, C.S. Marquez, G., Nelson, D., & Polomares, O., ``The
use of health information exchange to augment patient handoff in
long-term care: a systematic review,'' Applied Clinical Informatics,
2018, Vol. 9(4), pp. 752-771.
    \55\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R., ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
    \56\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation
during the transition to and from long-term care settings: a
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \57\ Levinson, D.R., & General, I., ``Adverse events in skilled
nursing facilities: national incidence among Medicare
beneficiaries.'' Washington, DC: U.S. Department of Health and Human
Services, Office of the Inspector General, February 2014. Available
at: https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
    \58\ Battles J., Azam I., Grady M., & Reback K., ``Advances in
patient safety and medical liability,'' AHRQ Publication No. 17-
0017-EF. Rockville, MD: Agency for Healthcare Research and Quality,
August 2017. Available at: https://www.ahrq.gov/sites/default/files/publications/files/advances-complete_3.pdf.
    \59\ Siefferman, J.W., Lin, E., & Fine, J.S. (2012). Patient
safety at handoff in rehabilitation medicine. Physical Medicine and
Rehabilitation Clinics of North America, 23(2), 241-257.
    \60\ Hale, J., Neal, E.B., Myers, A., Wright, K.H.S., Triplett,
J., Brown, L.B., & Mixon, A.S. (2015). Medication Discrepancies and
Associated Risk Factors Identified in Home Health patients. Home
Healthcare Now, 33(9), 493-499. https://doi.org/10.1097/NHH.0000000000000290.
    \61\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of
medication information across settings--keeping it free from
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \62\ Gleason, K.M., Groszek, J.M., Sullivan, C., Rooney, D.,
Barnard, C., Noskin, G.A., ``Reconciliation of discrepancies in
medication histories and admission orders of newly hospitalized
patients,'' American Journal of Health System Pharmacy, 2004, Vol.
61(16), pp. 1689-1694.
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    Patients in PAC settings often take multiple medications.
Consequently, PAC providers regularly are in the position of starting
complex new medication regimens with little knowledge of the patients
or their medication history upon admission. Medication discrepancies in
PAC are common, such as those identified in transition from hospital to
SNF \63\ and hospital to home.\64\ In one small intervention study,
approximately 90 percent of the sample of 101 patients experienced at
least one medication discrepancy in the transition from hospital to
home care.\65\
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    \63\ Tjia, J., Bonner, A., Briesacher, B.A., McGee, S., Terrill,
E., Miller, K., ``Medication discrepancies upon hospital to skilled
nursing facility transitions,'' J Gen Intern Med, 2009, Vol. 24(5),
pp. 630-635.
    \64\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, I.D.,
``Nurse identified hospital to home medication discrepancies:
implications for improving transitional care'', Geriatr Nurs, 2011
Vol. 31(3), pp.188-96.
    \65\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, I.D.,
``Nurse identified hospital to home medication discrepancies:
implications for improving transitional care'', Geriatr Nurs, 2011
Vol. 31(3), pp.188-96.
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    We would define a reconciled medication list as a list of the
current prescribed and over the counter (OTC) medications, nutritional
supplements,
[[Page 34647]]
vitamins, and homeopathic and herbal products administered by any route
to the patient/resident at the time of discharge or transfer.
Medications may also include but are not limited to total parenteral
nutrition (TPN) and oxygen. The current medications should include
those that are: (1) Active, including those that will be discontinued
after discharge; and (2) those held during the stay and planned to be
continued/resumed after discharge. If deemed relevant to the patient's/
resident's care by the subsequent provider, medications discontinued
during the stay may be included.
    A reconciled medication list often includes important information
about: (1) The patient/resident--including their name, date of birth,
information, active diagnoses, known medication and other allergies,
and known drug sensitivities and reactions; and (2) each medication,
including the name, strength, dose, route of medication administration,
frequency or timing, purpose/indication, any special instructions (for
example, crush medications), and, for any held medications, the reason
for holding the medication and when medication should resume. This
information can improve medication safety. Additional information may
be applicable and important to include in the medication list such as
the patient's/resident's weight and date taken, height and date taken,
patient's preferred language, patient's ability to self-administer
medication, when the last dose of the medication was administered by
the discharging provider, and when the final dose should be
administered (for example, end of treatment). This is not an exhaustive
list of the information that could be included in the medication list.
The suggested elements detailed in the definition above are for
guidance purposes only and are not a requirement for the types of
information to be included in a reconciled medication list in order to
meet the measure criteria.
(b) Stakeholder and TEP Input
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) measure was developed after consideration of feedback
we received from stakeholders and four TEPs convened by our
contractors. Further, the proposed measure was developed after
evaluation of data collected during two pilot tests we conducted in
accordance with the CMS Measures Management System Blueprint.
    Our measure development contractors convened a TEP, which met on
September 27, 2016,\66\ January 27, 2017, and August 3, 2017 \67\ to
provide input on a prior version of this measure. Based on this input,
we updated the measure concept in late 2017 to include the transfer of
a specific component of health information--medication information. Our
measure development contractors reconvened a TEP on April 20, 2018 for
the purpose of obtaining expert input on the proposed measure,
including the measure's reliability, components of face validity, and
the feasibility of implementing the measure across PAC settings.
Overall, the TEP was supportive of the measure, affirming that the
measure provides an opportunity to improve the transfer of medication
information. A summary of the April 20, 2018 TEP proceedings titled
``Transfer of Health Information TEP Meeting 4-June 2018'' 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.
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    \66\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \67\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
---------------------------------------------------------------------------
    Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS Measures
Management System Blueprint website, and accepted comments that were
submitted from March 19, 2018 to May 3, 2018. The comments received
expressed overall support for the measure. Several commenters suggested
ways to improve the measure, primarily related to what types of
information should be included at transfer. We incorporated this input
into development of the proposed measure. The summary report for the
March 19 to May 3, 2018 public comment period titled ``IMPACT--
Medication--Profile-- Transferred--Public--Comment--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.
(c) Pilot Testing
    The proposed measure was tested between June and August 2018 in a
pilot test that involved 24 PAC facilities/agencies, including five
IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted
a total of 801 records. Analysis of agreement between coders within
each participating facility (266 qualifying pairs) indicated a 93-
percent agreement for this measure. Overall, pilot testing enabled us
to verify its reliability, components of face validity, and feasibility
of being implemented across PAC settings. Further, more than half of
the sites that participated in the pilot test stated during the
debriefing interviews that the measure could distinguish facilities or
agencies with higher quality medication information transfer from those
with lower quality medication information transfer at discharge. The
pilot test 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.
(d) Measure Applications Partnership (MAP) Review and Related Measures
    We included the proposed measure on the 2018 Measures Under
Consideration (MUC) list for HH QRP. The NQF-convened MAP Post-Acute
Care- Long Term Care (PAC LTC) Workgroup met on December 10, 2018 and
provided input on this proposed Transfer of Health Information to the
Provider-Post-Acute Care measure. The MAP conditionally supported this
measure pending NQF endorsement, noting that the measure can promote
the transfer of important medication information. The MAP also
suggested that CMS consider a measure that can be adapted to capture
bi-directional information exchange and recommended that the medication
information transferred include important information about supplements
and opioids. More information about the MAP's recommendations for this
measure is available at: http://www.qualityforum.org/Projects/i-m/MAP/
PAC-LTC_Workgroup/
[[Page 34648]]
2019_Considerations_for_Implementing_Measures_Draft_Report.aspx.
    As part of the measure development and selection process, we
identified one NQF-endorsed quality measure related to the proposed
measure, titled Documentation of Current Medications in the Medical
Record (NQF #0419e, CMS eCQM ID: CMS68v8). This measure was adopted as
one of the recommended adult core clinical quality measures for
eligible professionals for the EHR Incentive Program beginning in 2014,
and was adopted under the Merit-based Incentive Payment System (MIPS)
quality performance category beginning in 2017. The measure is
calculated based on the percentage of visits for patients aged 18 years
and older for which the eligible professional or eligible clinician
attests to documenting a list of current medications using all
resources immediately available on the date of the encounter. The
proposed Transfer of Health Information to the Provider-Post-Acute Care
measure addresses the transfer of medication information whereas the
NQF-endorsed measure #0419e assesses the documentation of medications,
but not the transfer of such information. Further, the proposed measure
utilizes standardized patient assessment data elements (SPADEs), which
is a requirement for measures specified under the Transfer of Health
Information measure domain under section 1899B(c)(1)(E) of the Act,
whereas NQF #0419e does not. After review of the NQF-endorsed measure,
we determined that the proposed Transfer of Health Information to
Provider-Post-Acute Care measure better addresses the Transfer of
Health Information measure domain, which requires that at least some of
the data used to calculate the measure be collected as standardized
patient assessment data through post-acute care assessment instruments.
    Section 1899B(e)(2)(A) of the Act requires that measures specified
by the Secretary under section 1899B of the Act be endorsed by the
consensus-based entity with a contract under section 1890(a) of the
Act, which is currently the NQF. However, when a feasible and practical
measure has not been NQF endorsed for a specified area or medical topic
determined appropriate by the Secretary, section 1899B(e)(2)(B) of the
Act allows the Secretary to specify a measure that is not NQF endorsed
as long as due consideration is given to the measures that have been
endorsed or adopted by the consensus-based entity under a contract with
the Secretary. For these reasons, we believe that there is currently no
feasible NQF-endorsed measure that we could adopt under section
1899B(c)(1)(E) of the Act. However, we note that we intend to submit
the proposed measure to the NQF for consideration of endorsement when
feasible.
(e) Quality Measure Calculation
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) quality measure is calculated as the proportion of
quality episodes with a discharge/transfer assessment indicating that a
current reconciled medication list was provided to the admitting
provider at the time of discharge/transfer.
    The proposed measure denominator is the total number of quality
episodes ending in discharge/transfer to an ``admitting provider,''
which is defined as: A short-term general hospital, intermediate care,
home under care of another organized home health service organization
or a hospice, a hospice in an institutional facility, a SNF, an LTCH,
an IRF, an inpatient psychiatric facility, or a critical access
hospital (CAH). These providers were selected for inclusion in the
denominator because they represent admitting providers captured by the
current discharge location items on the OASIS. The proposed measure
numerator is the number of HH quality episodes (Start of Care or
Resumption of Care OASIS assessment and a Transfer or Discharge OASIS
Assessment) indicating a current reconciled medication list was
provided to the admitting provider at the time of discharge/transfer.
The proposed measure also collects data on how information is exchanged
in PAC facilities, informing consumers and providers on how information
was transferred at discharge/transfer. Data pertaining to how
information is transferred by PAC providers to other providers and/or
to patients/family/caregivers will provide important information to
consumers, improving shared-decision making while selecting PAC
providers. For additional technical information about this proposed
measure, including information about the measure calculation and the
standardized items used to calculate this measure, we refer readers to
the document titled, ``Proposed Specifications for HH QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' available
on the website 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 data
source for the proposed quality measure is the OASIS assessment
instrument for HH patients.
    For more information about the data submission requirements we are
proposing for this measure, we refer readers to section V.I.2. of this
proposed rule.
2. Proposed Transfer of Health Information to the Patient-Post-Acute
Care (PAC) Measure
    The proposed Transfer of Health Information to the Patient-Post-
Acute Care (PAC) measure is a process-based measure that assesses
whether or not a current reconciled medication list was provided to the
patient, family, and/or caregiver when the patient was discharged from
a PAC setting to a private home/apartment, a board and care home,
assisted living, a group home or transitional living.
(a) Background
    In 2013, 22.3 percent of all acute hospital discharges were
discharged to PAC settings, including 11 percent who were discharged to
home under the care of a home health agency.\68\ The communication of
health information, such as a reconciled medication list, is critical
to ensuring safe and effective patient transitions from health care
settings to home and/or other community settings. Incomplete or missing
health information, such as medication information, increases the
likelihood of a risk to patient safety, often life-
threatening.69 70 71 72 73 Individuals who use PAC care
services are particularly vulnerable to adverse health outcomes due to
their higher
[[Page 34649]]
likelihood of having multiple comorbid chronic conditions,
polypharmacy, and complicated transitions between care
settings.74 75 Upon discharge to home, individuals in PAC
settings may be faced with numerous medication changes, new medication
regimes, and follow-up details.76 77 78 The efficient and
effective communication and coordination of medication information may
be critical to prevent potentially deadly adverse events. When care
coordination activities enhance care transitions, these activities can
reduce duplication of care services and costs of care, resolve
conflicting care plans, and prevent medical errors.79 80
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    \68\ Tian, W. ``An all-payer view of hospital discharge to
postacute care,'' May 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \69\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
    \70\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
    \71\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \72\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
    \73\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
    \74\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
    \75\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E.,
Parsons, K.L., & Zuckerman, I.H., ``Medication reconciliation during
the transition to and from long-term care settings: a systematic
review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-75.
    \76\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H.,
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of
medication discrepancies between home health referrals and Centers
for Medicare and Medicaid Services home health certification and
plan of care and their potential to affect safety of vulnerable
elderly adults,'' Journal of the American Geriatrics Society, 2016,
Vol. 64(11), pp. e166-e170.
    \77\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \78\ Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B., Wolff,
J.L., Roth, D.L., Gabbard, J., & Boyd, C.M., ``Helping older adults
improve their medication experience (HOME) by addressing medication
regimen complexity in home healthcare,'' Home Healthcare Now. 2018,
Vol. 36(1) pp. 10-19.
    \79\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \80\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C.,
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner,
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and
preventable adverse events among hospitalized children following
implementation of a resident handoff bundle,'' JAMA, 2013, Vol.
310(21), pp. 2262-2270.
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    Finally, the transfer of a patient's discharge medication
information to the patient, family, and/or caregiver is a common
practice and supported by discharge planning requirements for
participation in Medicare and Medicaid programs.81 82 Most
PAC EHR systems generate a discharge medication list to promote patient
participation in medication management, which has been shown to be
potentially useful for improving patient outcomes and transitional
care.\83\
---------------------------------------------------------------------------
    \81\ CMS, ``Revision to state operations manual (SOM), Hospital
Appendix A--Interpretive Guidelines for 42 CFR 482.43, Discharge
Planning'' May 17, 2013. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-32.pdf.
    \82\ The State Operations Manual Guidance to Surveyors for Long
Term Care Facilities (Guidance Sec.  483.21(c)(1) Rev. 11-22-17) for
discharge planning process. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
    \83\ Toles, M., Colon-Emeric, C., Naylor, M.D., Asafu-Adjei, J.,
Hanson, L.C., ``Connect-home: transitional care of skilled nursing
facility patients and their caregivers,'' Am Geriatr Soc., 2017,
Vol. 65(10), pp. 2322-2328.
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(b) Stakeholder and TEP Input
    The proposed measure was developed after consideration of feedback
we received from stakeholders, and four TEPs convened by our
contractors. Further, the proposed measure was developed after
evaluation of data collected during two pilot tests, we conducted in
accordance with the CMS MMS Blueprint.
    Our measure development contractors convened a TEP which met on
September 27, 2016,\84\ January 27, 2017, and August 3, 2017 \85\ to
provide input on a prior version of this measure. Based on this input,
we updated the measure concept in late 2017 to include the transfer of
a specific component of health information--medication information. Our
measure development contractors reconvened this TEP on April 20, 2018
to seek expert input on the measure. Overall, the TEP members supported
the proposed measure, affirming that the measure provides an
opportunity to improve the transfer of medication information. Most of
the TEP members believed that the measure could improve the transfer of
medication information to patients, families, and caregivers. Several
TEP members emphasized the importance of transferring information to
patients and their caregivers in a clear manner using plain language. A
summary of the April 20, 2018 TEP proceedings titled ``Transfer of
Health Information TEP Meeting 4--June 2018'' 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.
---------------------------------------------------------------------------
    \84\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \85\ Technical Expert Panel Summary Report: Development of two
quality measures to satisfy the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health
Information and Care Preferences When an Individual Transitions to
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
---------------------------------------------------------------------------
    Our measure development contractors solicited stakeholder feedback
on the proposed measure by requesting comment on the CMS MMS Blueprint
website, and accepted comments that were submitted from March 19, 2018
to May 3, 2018. Several commenters noted the importance of ensuring
that the instruction provided to patients and caregivers is clear and
understandable to promote transparent access to medical record
information and meet the goals of the IMPACT Act. The summary report
for the March 19 to May 3, 2018 public comment period titled ``IMPACT--
Medication Profile Transferred Public Comment 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.
(c) Pilot Testing
    Between June and August 2018, we held a pilot test involving 24 PAC
facilities/agencies, including five IRFs, six SNFs, six LTCHs, and
seven HHAs. The 24 pilot sites submitted a total of 801 assessments.
Analysis of agreement between coders within each participating facility
(241 qualifying pairs) indicated 87 percent agreement for this measure.
Overall, pilot testing enabled us to verify its reliability, components
of face validity, and feasibility of being implemented the proposed
measure across PAC settings. Further, more than half of the sites that
participated in the pilot test stated, during debriefing interviews,
that the measure could distinguish facilities or agencies with higher
quality medication information transfer from those with lower quality
medication information transfer at discharge. The pilot test summary
report is available at: https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-
[[Page 34650]]
Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
The summary report for pilot testing conducted in 2017 of a previous
version of the data element, at that time intended for benchmarking
purposes only, 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.
(d) Measure Applications Partnership (MAP) Review and Related Measures
    This measure was submitted to the 2018 MUC list for HH QRP. The
NQF-convened MAP PAC-LTC Workgroup met on December 10, 2018 and
provided input on the use of the proposed Transfer of Health
Information to the Patient-Post Acute-Care measure. The MAP
conditionally supported this measure pending NQF endorsement, noting
that the measure can promote the transfer of important medication
information to the patient. The MAP recommended that providers transmit
medication information to patients that is easy to understand because
health literacy can impact a person's ability to take medication as
directed. More information about the MAP's recommendations for this
measure is available at: http://www.qualityforum.org/Projects/i-m/MAP/PAC-LTC_Workgroup/2019_Considerations_for_Implementing_Measures_Draft_Report.aspx.
    Section 1899B(e)(2)(A) of the Act requires that measures specified
by the Secretary under section 1899B of the Act be endorsed by the
entity with a contract under section 1890(a) of the Act, which is
currently the NQF. However, when a feasible and practical measure has
not been NQF-endorsed for a specified area or medical topic determined
appropriate by the Secretary, section 1899B(e)(2)(B) of the Act allows
the Secretary to specify a measure that is not NQF-endorsed as long as
due consideration is given to the measures that have been endorsed or
adopted by the consensus organization identified by the Secretary.
Therefore, in the absence of any NQF-endorsed measures that address the
proposed Transfer of Health Information to the Patient-Post-Acute Care
(PAC), which requires that at least some of the data used to calculate
the measure be collected as standardized patient assessment data
through the post-acute care assessment instruments, we believe that
there is currently no feasible NQF-endorsed measure that we could adopt
under section 1899B(c)(1)(E) of the Act. However, we note that we
intend to submit the proposed measure to the NQF for consideration of
endorsement when feasible.
(e) Quality Measure Calculation
    The calculation of the proposed Transfer of Health Information to
Patient-Post-Acute Care measure would be based on the proportion of
quality episodes with a discharge assessment indicating that a current
reconciled medication list was provided to the patient, family, and/or
caregiver at the time of discharge.
    The proposed measure denominator is the total number of HH quality
episodes ending in discharge to a private home/apartment without any
further services, a board and care home, assisted living, a group home
or transitional living. These health care providers and settings were
selected for inclusion in the denominator because they represent
discharge locations captured by items on the OASIS. The proposed
measure numerator is the number of HH quality episodes with an OASIS
discharge assessment indicating a current reconciled medication list
was provided to the patient, family, and/or caregiver at the time of
discharge. We believe that data pertaining to how information is
transferred by PAC providers to other providers and/or to patients/
family/caregivers will provide important information to consumers,
improving shared-decision making while selecting PAC providers. For
technical information about this proposed measure including information
about the measure calculation, we refer readers to the document titled
``Proposed Specifications for HH QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' 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
    For more information about the data submission requirements we are
proposing for this measure, we refer readers to section V.I.2. of this
proposed rule.
3. Proposed Update to the Discharge to Community (DTC)--Post Acute Care
(PAC) Home Health (HH) Quality Reporting Program (QRP) Measure
    We are proposing to update the specifications for the DTC--PAC HH
QRP measure to exclude baseline nursing facility (NF) residents from
the measure. This proposed measure exclusion aligns with the proposed
updates to measure exclusions for the DTC-PAC measures utilized in
quality reporting programs for other PAC providers, as outlined in the
FY2020 PPS proposed rules for IRFs and SNFs as well as for LTCHs in the
FY2020 IPPS/LTCH PPS proposed rule. This measure assesses successful
discharge to the community from an HHA, with successful discharge to
the community including no unplanned re-hospitalizations and no death
in the 31 days following discharge. We adopted this measure in the CY
2017 HH PPS final rule (81 FR 76765 through 76770).
    The DTC-PAC HH QRP measure does not currently exclude baseline NF
residents. We have now developed a methodology to identify and exclude
baseline NF residents using the Minimum Data Set (MDS) and have
conducted additional measure testing work. To identify baseline NF
residents, we examine any historical MDS data in the 180 days preceding
the qualifying prior acute care admission and index HH episode of care
start date. Presence of an OBRA (Omnibus Budget Reconciliation Act)-
only assessment (not a SNF PPS assessment) with no intervening
community discharge between the OBRA assessment and acute care
admission date flags the index HH episode of care as baseline NF
resident. We assessed the impact of the baseline NF resident exclusion
on HH patient- and agency-level discharge to community rates using CY
2016 and CY 2017 Medicare FFS claims data. Baseline NF residents
represented 0.13 percent of the measure population after all measure
exclusions were applied. The national observed patient-level discharge
to community rate was 78.05 percent when baseline NF residents were
included in the measure, increasing to 78.08 percent when they were
excluded from the measure. After excluding baseline NF residents to
align with current or proposed exclusions in other PAC settings, the
agency-level risk-standardized discharge to community rate ranged from
3.21 percent to 100 percent, with a mean of 77.39 percent and standard
deviation of 17.27 percentage points, demonstrating a performance gap
in this domain. That is, the results show that there is a wide range in
measure results, emphasizing the opportunity for providers to improve
their measure performance.
    Accordingly, we are proposing to exclude baseline NF residents from
the DTC-PAC HH QRP measure beginning with the CY 2021 HH QRP. We are
proposing to define ``baseline NF residents'' for purposes of this
measure as HH patients who had a long-term NF stay in the 180 days
preceding their hospitalization and HH episode, with no
[[Page 34651]]
intervening community discharge between the NF stay and qualifying
hospitalization. We are currently using MDS assessments, which are
required quarterly for NF residents, to identify baseline NF residents.
A 180-day lookback period ensures that we will capture both quarterly
OBRA assessments identifying NF residency and any discharge assessments
to determine if there was a discharge to community from NF.
    For additional technical information regarding the DTC-PAC HH QRP
measure, including technical information about the proposed exclusion,
we refer readers to the document titled ``Proposed Specifications for
HH QRP Quality Measures and Standardized Patient Assessment Data
Elements,'' 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.
F. HH QRP Quality Measures, Measure Concepts, and Standardized Patient
Assessment Data Elements Under Consideration for Future Years: Request
for Information
    We are seeking input on the importance, relevance, appropriateness,
and applicability of each of the measures, standardized patient
assessment data elements (SPADEs), and measure concepts under
consideration listed in the Table 27 for future years in the HH QRP.
[GRAPHIC] [TIFF OMITTED] TP18JY19.070
    While we will not be responding to comment submissions in response
to this Request for Information in the CY 2020 HH PPS final rule, nor
will we be finalizing any of these measures, measure concepts, and
SPADEs under consideration for the HH QRP in this CY 2020 HH PPS final
rule, we intend to use this input to inform our future measure and
SPADE development efforts.
G. Proposed Standardized Patient Assessment Data Reporting Beginning
With the CY 2022 HH QRP
    Section 1895(b)(3)(B)(v)(IV)(bb) of the Act requires that, for CY
2019 (beginning January 1, 2019) and each subsequent year, HHAs report
standardized patient assessment data required under section 1899B(b)(1)
of the Act. Section 1899B(a)(1)(C) of the Act requires, in part, the
Secretary to modify the PAC assessment instruments in order for PAC
providers, including HHAs, to submit SPADEs under the Medicare program.
Section 1899B(b)(1)(A) of the Act requires that PAC providers must
submit SPADEs under applicable reporting provisions, (which for HHAs is
the HH QRP) with respect to the admissions and discharges of an
individual (and more frequently as the Secretary deems appropriate),
and section 1899B(b)(1)(B) defines standardized patient assessment data
as data required for at least the quality measures described in section
1899B(c)(1) of the Act and that is with respect to the following
categories: (1) Functional status, such as mobility and self-care at
admission to a PAC provider and before discharge from a PAC provider;
(2) cognitive function, such as ability to express ideas and to
understand, and mental status, such as depression and dementia; (3)
special services, treatments, and interventions, such as need for
ventilator use, dialysis, chemotherapy, central line placement, and
total parenteral nutrition; (4) medical conditions and comorbidities,
such as diabetes, congestive heart failure, and pressure ulcers; (5)
impairments, such as incontinence and an impaired ability to hear, see,
or swallow; and (6) other categories deemed necessary and appropriate
by the Secretary.
    In the CY 2018 HH PPS proposed rule (82 FR 35355 through 35371), we
proposed to adopt SPADEs that would satisfy the first five categories.
While many commenters expressed support for our adoption of SPADEs,
including support for our broader standardization goal and support for
the clinical usefulness of specific proposed SPADEs in general, we did
not finalize the majority of our SPADE proposals in recognition of the
concern raised by many commenters that we were moving too fast to adopt
the SPADEs and modify our assessment instruments in light of all of the
other requirements we were also adopting under the IMPACT Act at that
time (82 FR 51737 through 51740). In addition, we noted our intention
to conduct extensive testing to ensure that the standardized patient
assessment data elements we select are reliable, valid, and appropriate
for their intended use (82 FR 51732 through 51733).
    However, we did, finalize the adoption of SPADEs for two of the
categories described in section 1899B(b)(1)(B) of the Act: (1)
Functional status: Data elements currently reported
[[Page 34652]]
by HHAs to calculate the 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) along
with the additional data elements in Section GG: Functional Abilities
and Goals; and (2) Medical conditions and comorbidities: The data
elements used to calculate the pressure ulcer measures, Percent of
Residents or Patients with Pressure Ulcers That Are New or Worsened
(Short Stay) (NQF #0678) and the replacement measure, Changes in Skin
Integrity Post-Acute Care: Pressure Ulcer/Injury. We stated that these
data elements were important for care planning, known to be valid and
reliable, and already being reported by HHAs for the calculation of
quality measures (82 FR 51733 through 51735).
    Since we issued the CY 2018 HH PPS final rule, HHAs have had an
opportunity to familiarize themselves with other new reporting
requirements that we have adopted under the IMPACT Act. We have also
conducted further testing of the proposed SPADEs, as described more
fully elsewhere in this proposed rule, and believe that this testing
supports their use in our PAC assessment instruments. Therefore, we are
now proposing to adopt many of the same SPADEs that we previously
proposed to adopt, along with other SPADEs.
    We are proposing that HHAs would be required to report these SPADEs
beginning with the CY 2022 HH QRP. If finalized as proposed, HHAs would
be required to report this data with respect to admissions and
discharges that occur between January 1, 2021 and June 30, 2021 for the
CY 2022 HH QRP. Beginning with the CY 2023 HH QRP, we propose that HHAs
must report data with respect to admissions and discharges that occur
the successive calendar year (for example, data from FY 2021 for the CY
2023 HH QRP and data from FY 2022 for the CY 2024 HH QRP). For the
purposes of the HH QRP, we are proposing that HHAs must submit SPADEs
with respect to start of care (SOC), resumption of care (ROC), and
discharge with the exception of Hearing, Vision, Race, and Ethnicity
SPADEs, which will only be collected with respect to SOC. We are
proposing to use SOC for purposes of admissions because, in the HH
setting, the start of care is functionally the same as an admission.
    We are proposing that HHAs that submit the Hearing, Vision, Race,
and Ethnicity SPADEs with respect to SOC only will be deemed to have
submitted those SPADEs with respect to both admission and discharge,
because it is unlikely that the assessment of those SPADEs at admission
will differ from the assessment of the same SPADEs at discharge.
    We considered the burden of assessment-based data collection and
aimed to minimize additional burden by evaluating whether any data that
is currently collected through one or more PAC assessment instruments
could be collected as SPADE. In selecting the proposed SPADEs in this
proposed rule, we also took into consideration the following factors
with respect to each data element:
     Overall clinical relevance;
     Interoperable exchange to facilitate care coordination
during transitions in care;
     Ability to capture medical complexity and risk factors
that can inform both payment and quality;
     Scientific reliability and validity, general consensus
agreement for its usability.
    In identifying the SPADEs proposed, we additionally drew on input
from several sources, including TEPs, public input, and the results of
a recent National Beta Test of candidate data elements conducted by our
data element (hereafter ``National Beta Test''), contractor.
    The National Beta Test collected data from 3,121 patients and
residents across 143 LTCHs, SNFs, IRFs, and HHAs from November 2017 to
August 2018 to evaluate the feasibility, reliability, and validity of
candidate data elements across PAC settings. The National Beta Test
also gathered feedback on the candidate data elements from staff who
administered the test protocol in order to understand usability and
workflow of the candidate data elements. More information on the
methods, analysis plan, and results for the National Beta Test can be
found in the document titled, ``Development and Evaluation of Candidate
Standardized Patient Assessment Data Elements: Findings from the
National Beta Test (Volume 2),'' 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.
    Further, to inform the proposed SPADEs, we took into account
feedback from stakeholders, as well as from technical and clinical
experts, including feedback on whether the candidate data elements
would support the factors described previously. Where relevant, we also
took into account the results of the Post-Acute Care Payment Reform
Demonstration (PAC PRD) that took place from 2006 to 2012.
H. Proposed Standardized Patient Assessment Data by Category
1. Cognitive Function and Mental Status Data
    A number of underlying conditions, including dementia, stroke,
traumatic brain injury, side effects of medication, metabolic and/or
endocrine imbalances, delirium, and depression, can affect cognitive
function and mental status in PAC patient and resident populations.\86\
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,\87\ and because these assessments provide
opportunity for improving quality of care.
---------------------------------------------------------------------------
    \86\ 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.
    \87\ 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.
---------------------------------------------------------------------------
    Symptoms of dementia may improve with pharmacotherapy, occupational
therapy, or physical activity,88 89 90 and promising
treatments for severe traumatic brain injury are currently being
tested.\91\ For older patients and residents diagnosed with depression,
treatment options to reduce symptoms and improve quality of life
include antidepressant medication and
psychotherapy,92 93 94 95 and targeted
[[Page 34653]]
services, such as therapeutic recreation, exercise, and restorative
nursing, to increase opportunities for psychosocial interaction.\96\
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    \88\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for
Alzheimer's Disease: Are They Effective? Pharmacology &
Therapeutics, 35, 208-11.
    \89\ 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.
    \90\ 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.
    \91\ 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.
    \92\ 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.
    \93\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined
psychotherapy/pharmacotherapy for late life depression. Biological
Psychiatry, 52(3), 293-303.
    \94\ 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.
    \95\ 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.
    \96\ 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.
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    In alignment with our Meaningful Measures Initiative, accurate
assessment of cognitive function and mental status of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promoting effective prevention and treatment
of chronic disease; strengthening person and family engagement as
partners in their care; and promoting effective communication and
coordination of care. 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's 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. SPADEs 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. Therefore, reliable SPADEs
assessing cognitive function and mental status are needed in order to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events. We
describe each of the proposed cognitive function and mental status data
SPADEs elsewhere in the proposed rule.
    We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to cognitive
function and mental status.
a. Brief Interview for Mental Status (BIMS)
    We are proposing that the data elements that comprise the BIMS meet
the definition of standardized patient assessment data with respect to
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35356
through 35357), dementia and cognitive impairment are associated with
long-term functional dependence and, consequently, poor quality of life
and increased health care costs and mortality.\97\ This makes
assessment of mental status and early detection of cognitive decline or
impairment critical in the PAC setting. 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
providers.\98\
---------------------------------------------------------------------------
    \97\ 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.
    \98\ RTI International. Proposed Measure Specifications for
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle
Park, NC. 2016.
---------------------------------------------------------------------------
    The BIMS is a performance-based cognitive assessment screening tool
that assesses repetition, recall with and without prompting, and
temporal orientation. The data elements that make up the BIMS are seven
questions on the repetition of three words, temporal orientation, and
recall that result in a cognitive function score. The BIMS was
developed to be a brief objective screening tool with a focus on
learning and memory. As a brief screener, the BIMS was not designed to
diagnose dementia or cognitive impairment, but rather to be a
relatively quick and easy to score assessment that could identify
cognitively impaired patients as well as those who may be at risk for
cognitive decline and require further assessment. It is currently in
use in two of the PAC assessments: The MDS in SNFs and the IRF-PAI used
by IRFs. For more information on the BIMS, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' 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 data elements that comprise the BIMS were first proposed as
SPADEs in the CY 2018 HH PPS proposed rule (82 FR 35356 through 35357).
In that proposed rule, we stated that the proposal was informed by
input we received through a call for input published on the CMS
Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 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. We also stated
that those commenters had 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 summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the use of the BIMS in the HH
setting. However, a commenter suggested the BIMS should be administered
with respect to both admission and discharge, and another commenter
encouraged its use at follow-up assessments. Another commenter
expressed support for the BIMS to assess significant cognitive
impairment, but a few commenters suggested alternative cognitive
assessments as more appropriate for the HH settings, such as
assessments that would capture mild cognitive impairment and
``functional cognition.''
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the BIMS was included in the National Beta Test of candidate data
elements conducted by our data element contractor from November 2017 to
August 2018. Results of this test found the BIMS to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the BIMS in the National Beta Test can be
found in the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the BIMS, and
the TEP supported the assessment of patient or resident cognitive
status with respect to both admission and discharge. A summary of the
September 17, 2018 TEP
[[Page 34654]]
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Some commenters expressed concern that the BIMS, if used alone,
may not be sensitive enough to capture the range of cognitive
impairments, including mild cognitive impairment (MCI). A summary of
the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on SPADEs Received After November 27, 2018
Stakeholder Meeting'' 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 understand the concerns raised by stakeholders that BIMS, if
used alone, may not be sensitive enough to capture the range of
cognitive impairments, including functional cognition and MCI, but note
that the purpose of the BIMS data elements as SPADEs is to screen for
cognitive impairment in a broad population. We also acknowledge that
further cognitive tests may be required based on a patient's condition
and will take this feedback into consideration in the development of
future standardized assessment data elements. However, taking together
the importance of assessing cognitive status, stakeholder input, and
strong test results, we are proposing that the BIMS data elements meet
the definition of standardized patient assessment data with respect to
cognitive function and mental status under section 1899B(b)(1)(B)(ii)
of the Act and to adopt the BIMS as standardized patient assessment
data for use in the HH QRP.
b. Confusion Assessment Method (CAM)
    In this proposed rule, we are proposing that the data elements that
comprise the Confusion Assessment Method (CAM) meet the definition of
standardized patient assessment data with respect to cognitive function
and mental status under section 1899B(b)(1)(B)(ii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35357), the
CAM was developed to identify the signs and symptoms of delirium. It
results in a score that suggests whether a 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.\99\
Assessing these signs and symptoms of delirium is clinically relevant
for care planning by PAC providers.
---------------------------------------------------------------------------
    \99\ 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 a patient assessment instrument that screens for overall
cognitive impairment, as well as distinguishes delirium or reversible
confusion from other types of cognitive impairment. The CAM is
currently in use in two of the PAC assessments: A four-item version of
the CAM is used in the MDS in SNFs, and a six-item version of the CAM
is used in the LTCH CARE Data Set (LCDS) in LTCHs. We are proposing the
four-item version of the CAM that assesses acute change in mental
status, inattention, disorganized thinking, and altered level of
consciousness. For more information on the CAM, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' 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 data elements that comprise the CAM were first proposed as
SPADEs in the CY 2018 HH PPS proposed rule (82 FR 35357). In that
proposed rule, we stated that the proposal was informed by input we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted on the CAM from
August 12 to September 12, 2016 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. We also stated that those commenters had noted the CAM is
particularly helpful in distinguishing delirium and reversible
confusion from other types of cognitive impairment. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the CAM to assess significant
cognitive impairment but noted that functional cognition should also be
assessed. Another commenter suggested the CAM was not suitable for the
HH setting and noted that the additional cognition items would be
redundant with existing assessment items in the OASIS data set.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the CAM was included in the National Beta Test of candidate data
elements conducted by our data element contractor from November 2017 to
August 2018. Results of this test found the CAM to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the CAM in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018, although they did not specifically discuss the CAM
data elements, the TEP supported the assessment of patient or resident
cognitive status with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of
[[Page 34655]]
stakeholders to present the results of the National Beta Test and
solicit additional comments. General input on the testing and item
development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing delirium, stakeholder
input, and strong test results, we are proposing that the CAM data
elements meet the definition of standardized patient assessment data
with respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act and to adopt CAM as standardized patient
assessment data for use in the HH QRP.
c. Patient Health Questionnaire-2 to 9 (PHQ-2 to 9)
    We are proposing that the Patient Health Questionnaire-2 to 9 (PHQ-
2 to 9) data elements meet the definition of standardized patient
assessment data with respect to cognitive function and mental status
under section 1899B(b)(1)(B)(ii) of the Act. The proposed data elements
are based on the PHQ-2 mood interview, which focuses on only the two
cardinal symptoms of depression, and the longer PHQ-9 mood interview,
which assesses presence and frequency of nine signs and symptoms of
depression. The name of the data element, the PHQ-2 to 9, refers to an
embedded skip pattern that transitions patients with a threshold level
of symptoms in the PHQ-2 to the longer assessment of the PHQ-9. The
skip pattern is described elsewhere in this proposed rule.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35358
through 35359), depression is a common and under-recognized mental
health condition. Assessments of depression help PAC providers better
understand the needs of their patients and residents by: Prompting
further evaluation after establishing 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.
    The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The
PHQ-2 consists of questions about only the first two symptoms addressed
in the PHQ-9: Depressed mood and anhedonia (inability to feel
pleasure), which are the cardinal symptoms of depression. The PHQ-2 has
performed well as both a screening tool for identifying depression, to
assess depression severity, and to monitor patient mood over
time.100 101 If a patient demonstrates signs of depressed
mood and anhedonia under the PHQ-2, then the patient is administered
the lengthier PHQ-9. This skip pattern (also referred to as a gateway)
is designed to reduce the length of the interview assessment for
patients who fail to report the cardinal symptoms of depression. The
design of the PHQ-2 to 9 reduces the burden that would be associated
with the full PHQ-9, while ensuring that patients with indications of
depressive symptoms based on the PHQ-2 receive the longer assessment.
---------------------------------------------------------------------------
    \100\ Li, C., Friedman, B., Conwell, Y., & Fiscella, K. (2007).
``Validity of the Patient Health Questionnaire 2 (PHQ-2) in
identifying major depression in older people.'' J of the A
Geriatrics Society, 55(4): 596-602.
    \101\ L[ouml]we, B., Kroenke, K., & Gr[auml]fe, K. (2005).
``Detecting and monitoring depression with a two-item questionnaire
(PHQ-2).'' J of Psychosomatic Research, 58(2): 163-171.
---------------------------------------------------------------------------
    Components of the proposed data elements are currently used in the
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We are proposing
to add the additional data elements of the PHQ-9 to the OASIS to
replace M1730, Depression Screening. We are proposing to alter the
administration instructions for the existing and new data elements to
adopt the PHQ-2 to 9 gateway logic, meaning that administration of the
full PHQ-9 is contingent on patient responses to questions about the
cardinal symptoms of depression. For more information on the PHQ-2 to
9, we refer readers to the document titled, ``Proposed Specifications
for HH QRP Quality Measures and SPADEs,'' 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 PHQ-2 data elements were first proposed as SPADEs in the CY
2018 HH proposed rule (82 FR 35358 through 35359). In that proposed
rule, we stated that the proposal was informed by input we received
from the TEP convened by our data element contractor on April 6 and 7,
2016. The TEP members particularly noted that the brevity of the PHQ-2
made it feasible to administer with low burden for both assessors and
PAC patients or residents. A summary of the April 6 and 7, 2016 TEP
meeting titled ``SPADE Technical Expert Panel Summary (First
Convening)'' 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.
    That rule proposal was also informed by public input that we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input was submitted from August 12
to September 12, 2016 on three versions of the PHQ depression screener:
The PHQ-2; the PHQ-9; and the PHQ-2 to 9 with the skip pattern design.
Many commenters were supportive of the standardized assessment of mood
in PAC settings, 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 while still potentially reducing
burden on most patients and residents, as well as test administrators,
and ensuring the administration of the PHQ-9, which exhibits higher
specificity,\102\ for patients and residents who showed signs and
symptoms of depression on the PHQ-2. A summary report for to the
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment 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.
---------------------------------------------------------------------------
    \102\ 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.
---------------------------------------------------------------------------
    In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the PHQ-2, with a few commenters
noting the limitation that the PHQ-2 is not appropriate for patients
who are physically or cognitively impaired.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the PHQ-2 to 9 data elements were included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the PHQ-2 to 9 to be feasible and reliable for use with PAC
patients and residents. More
[[Page 34656]]
information about the performance of the PHQ-2 to 9 in the National
Beta Test can be found in the document titled, ``Proposed
Specifications for CY 2020 HH QRP Quality Measures and Standardized
Patient Assessment Data Elements,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018, for the purpose of soliciting input on the PHQ-2 to
9. The TEP was supportive of the PHQ-2 to 9 data element set as a
screener for signs and symptoms of depression. The TEP's discussion
noted that symptoms evaluated by the full PHQ-9 (for example,
concentration, sleep, appetite) had relevance to care planning and the
overall well-being of the patient or resident, but that the gateway
approach of the PHQ-2 to 9 would be appropriate as a depression
screening assessment, as it depends on the well-validated PHQ-2 and
focuses on the cardinal symptoms of depression. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing depression, stakeholder
input, and strong test results, we are proposing that the PHQ-2 to 9
data elements meet the definition of standardized patient assessment
data with respect to cognitive function and mental status under section
1899B(b)(1)(B)(ii) of the Act and to adopt the PHQ-2 to 9 data elements
as standardized patient assessment data for use in the HH QRP.
2. 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. In alignment with our
Meaningful Measures Initiative, accurate assessment of special
services, treatments, and interventions of patients and residents
served by PAC providers is expected to make care safer by reducing harm
caused in the delivery of care; promoting effective prevention and
treatment of chronic disease; strengthening person and family
engagement as partners in their care; and promoting effective
communication and coordination of care.
    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.
Therefore, reliable data elements assessing special services,
treatments, and interventions are needed to initiate a management
program that can optimize a patient's or resident's prognosis and
reduce the possibility of adverse events. We provide rationale and
further support for each of the proposed data elements and in the
document titled, ``Proposed Specifications for CY 2020 HH QRP Quality
Measures and Standardized Patient Assessment Data Elements,'' 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 our data element contractor provided input on the
data elements for special services, treatments, and interventions. In a
meeting held on January 5 and 6, 2017, the TEP found 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 summary of the January 5 and 6,
2017 TEP meeting titled ``SPADE Technical Expert Panel Summary (Second
Convening)'' 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.
    Comments on the category of special services, treatments, and
interventions were also submitted by stakeholders during the CY 2018 HH
PPS proposed rule (82 FR 35359 through 35369) public comment period. A
few commenters expressed support for the special services, treatments,
and interventions data elements but requested that a vendor be
contracted to support OASIS questions and answers. A commenter noted
that many of these data elements were redundant with current assessment
items and encouraged CMS to eliminate the redundancy by removing items
similar to the proposed data elements. Another commenter noted that
collecting these data elements on patients that come to the HH setting
from non-affiliated entities can be challenging. The Medicare Payment
Advisory Commission supported the addition of data elements related to
specific services, treatments, and interventions, but cautioned that
such data elements, when used for risk adjustment, may be susceptible
to inappropriate manipulation by providers and expressed that CMS may
want to consider requiring a physician signature to attest that the
reported service was reasonable and necessary. CMS is not proposing to
require a physician signature because the existing Conditions of
Participation for HHAs
[[Page 34657]]
already require accurate reporting of patient assessment data, and a
physician signature would be redundant. We reported this comment in
order to accurately represent the public comments received on these
proposals in the CY 2017 HH PPS proposed rule.
    We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to special
services, treatments, and interventions.
a. Cancer Treatment: Chemotherapy (IV, Oral, Other)
    We are proposing that the Chemotherapy (IV, Oral, Other) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35359
through 35360), 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 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 is administered either peripherally or 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) for IV chemotherapy require significant resources.
    The Chemotherapy (IV, Oral, Other) data element consists of a
principal data element (Chemotherapy) and three response option sub-
elements: IV chemotherapy, which is generally resource-intensive; Oral
chemotherapy, which is less invasive and generally requires less
intensive administration protocols; and a third category, Other,
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 chemotherapy delivery by
other routes (for example, intraventricular or intrathecal). If the
assessor indicates that the patient is receiving chemotherapy on the
principal Chemotherapy data element, the assessor would then indicate
by which route or routes (IV, Oral, Other) the chemotherapy is
administered.
    A single Chemotherapy data element that does not include the
proposed three sub-elements is currently in use in the MDS in SNFs. For
more information on the Chemotherapy (IV, Oral, Other) data element, we
refer readers to the document titled ``Proposed Specifications for HH
QRP Quality Measures and SPADEs,'' 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 Chemotherapy data element was first proposed as a SPADE in the
CY 2018 HH PPS proposed rule (82 FR 35359 through 35360). In that
proposed rule, we stated that the proposal was informed by input we
received through a call for input published on the CMS Measures
Management System Blueprint website. Input submitted from August 12 to
September 12, 2016 expressed support for the IV Chemotherapy data
element and suggested it be included as standardized patient assessment
data. We also stated that those commenters had noted 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 summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Chemotherapy data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Chemotherapy data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Chemotherapy data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Chemotherapy data element in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the special
services, treatments, and interventions. Although the TEP members did
not specifically discuss the Chemotherapy data element, the TEP members
supported the assessment of the special services, treatments, and
interventions included in the National Beta Test with respect to both
admission and discharge. A summary of the September 17, 2018 TEP
meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting
[[Page 34658]]
and via email through February 1, 2019. A summary of the public input
received from the November 27, 2018 stakeholder meeting titled ``Input
on SPADEs Received After November 27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing chemotherapy,
stakeholder input, and strong test results, we are proposing that the
Chemotherapy (IV, Oral, Other) data element with a principal data
element and three sub-elements meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Chemotherapy (IV, Oral, Other) data element as standardized
patient assessment data for use in the HH QRP.
b. Cancer Treatment: Radiation
    We are proposing that the Radiation data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35360),
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 proposed data element consists of the single Radiation data
element. The Radiation data element is currently in use in the MDS for
SNFs. For more information on the Radiation data element, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs,'' 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 Radiation data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35360). In that proposed rule, we stated that the proposal was
informed by input we received through a call for input published on the
CMS Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 expressed support for the Radiation
data element, noting its importance and clinical usefulness for
patients and residents in PAC settings, due to the side effects and
consequences of radiation treatment on patients and residents that need
to be considered in care planning and care transitions, the feasibility
of the item, and the potential for it to improve quality. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the special services,
treatments, and interventions data elements in general; no additional
comments were received that were specific to the Radiation data
element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Radiation data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Radiation data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Radiation data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP members did not specifically
discuss the Radiation data element, the TEP members supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing radiation, stakeholder
input, and strong test results, we are proposing that the Radiation
data element meets the definition of standardized patient assessment
data with respect to special services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Radiation
data element as standardized patient assessment data for use in the HH
QRP.
c. Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery System)
    We are proposing that the Oxygen Therapy (Intermittent, Continuous,
High-Concentration Oxygen Delivery System) data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35360
through 35361), we proposed a data element
[[Page 34659]]
related to oxygen therapy. 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). The data element proposed here capture patient or resident use
of three types of oxygen therapy (intermittent, continuous, and high-
concentration oxygen delivery system), which reflects the intensity of
care needed, 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 element, Oxygen Therapy, consists of the
principal Oxygen Therapy data element and three sub-elements:
Continuous (whether the oxygen was delivered continuously, typically
defined as > =14 hours per day); Intermittent; or High-concentration
oxygen delivery system. Based on public comments and input from expert
advisors about the importance and clinical usefulness of documenting
the extent of oxygen use, we added a third sub-element, high-
concentration oxygen delivery system, to the sub-elements, which
previously included only intermittent and continuous. If the assessor
indicates that the patient is receiving oxygen therapy on the principal
oxygen therapy data element, the assessor would then indicate the type
of oxygen the patient receives (for example, Continuous, Intermittent,
High-concentration oxygen delivery system).
    These three proposed sub-elements were developed based on similar
data elements that assess oxygen therapy, currently in use in the MDS
for SNFs (``Oxygen Therapy''), previously used in the OASIS-C2 for HHAs
(``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 percent''). For more
information on the proposed Oxygen Therapy (Continuous, Intermittent,
High-concentration oxygen delivery system) data element, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs'', 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 Oxygen Therapy (Continuous, Intermittent) data element was
first proposed as a standardized patient assessment data element in the
CY 2018 HH PPS proposed rule (82 FR 35360 through 35361). In that
proposed rule, we stated that the proposal was informed by input we
received on the single data element, Oxygen (inclusive of intermittent
and continuous oxygen use), through a call for input published on the
CMS Measures Management System Blueprint website. Input submitted from
August 12 to September 12, 2016 expressed 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 summary report for the August 12 to September 12, 2016
public comment period titled ``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Oxygen Therapy (Continuous,
Intermittent) data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Oxygen Therapy data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Oxygen Therapy data element to be feasible and reliable for
use with PAC patients and residents. More information about the
performance of the Oxygen Therapy data element in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs'', 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018, although the TEP did not specifically discuss the
Oxygen Therapy data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing oxygen therapy,
stakeholder input, and strong test results, we are proposing that the
Oxygen Therapy (Continuous, Intermittent, High-Concentration Oxygen
Delivery System) data element with a principal data element and three
sub-elements meets the definition of standardized patient assessment
data with respect to special services, treatments, and interventions
under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen
(Continuous, Intermittent, High-Concentration Oxygen Delivery System)
data element as standardized patient assessment data for use in the HH
QRP.
d. Respiratory Treatment: Suctioning (Scheduled, As Needed)
    We are proposing that the Suctioning (Scheduled, As needed) data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35361
through
[[Page 34660]]
35362), 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' or
residents' care plans, both to prevent the accumulation of secretions
than can lead to aspiration pneumonias (a common condition in patients
and residents 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 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. 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.
    The Suctioning (Scheduled, As needed) data element consists of the
principal 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. If the assessor indicates that
the patient is receiving suctioning on the principal Suctioning data
element, the assessor would then indicate the frequency (Scheduled, As
needed). The proposed data element is based on an item currently in use
in the MDS in SNFs which does not include our proposed two sub-
elements, as well as data elements tested in the PAC PRD that focused
on the frequency of suctioning required for patients and residents with
tracheostomies (``Trach Tube with Suctioning: Specify most intensive
frequency of suctioning during stay [Every _ hours]''). For more
information on the Suctioning data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs'', 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 Suctioning data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35361 through 35362). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted from August 12 to September 12, 2016 expressed support
for the Suctioning data element currently used in the MDS in SNFs. The
input noted the feasibility of this item in PAC, and the relevance of
this data element to facilitating care coordination and supporting care
transitions. We also stated that those commenters had suggested that we
examine the frequency of suctioning 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 Suctioning data element includes both
the principal Suctioning data element that is included on the MDS in
SNFs and two sub-elements, Scheduled and As needed. A summary report
for the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Suctioning data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Suctioning data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Suctioning data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Suctioning data element in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs'', 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Suctioning data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicited additional comments. General input on the
testing and item development process and concerns about burden were
received from stakeholders during this meeting and via email through
February 1, 2019. A summary of the public input received from the
November 27, 2018 stakeholder meeting titled ``Input on SPADEs Received
After November 27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing suctioning, stakeholder
input, and strong test results, we are proposing that the Suctioning
(Scheduled, As needed) data element with a principal data element and
two sub-elements meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to
[[Page 34661]]
adopt the Suctioning (Scheduled, As needed) data element as
standardized patient assessment data for use in the HH QRP.
e. Respiratory Treatment: Tracheostomy Care
    We are proposing that the Tracheostomy Care data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35362), 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 if 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. In addition, tracheostomy
care, which primarily consists of cleansing, dressing changes, and
replacement of the tracheostomy cannula 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 consists of the single Tracheostomy Care
data element. The proposed data element is currently in use in the MDS
for SNFs (``Tracheostomy care''). For more information on the
Tracheostomy Care data element, we refer readers to the document titled
``Proposed Specifications for HH QRP Quality Measures and SPADEs'',
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 Tracheostomy Care data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35362). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on the Tracheostomy Care data element from August 12 to
September 12, 2016 supported 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
summary report for the August 12 to September 12, 2016 public comment
period titled ``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Tracheostomy Care data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Tracheostomy Care data element was included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Tracheostomy Care data element to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Tracheostomy Care data element in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs'', 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Tracheostomy Care data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing tracheostomy care,
stakeholder input, and strong test results, we are proposing that the
Tracheostomy Care data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Tracheostomy Care data element as standardized patient
assessment data for use in the HH QRP.
f. 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 element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35362
through 35363), 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 (BiPAP) or
through a mask continuously (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
[[Page 34662]]
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.
    The proposed data element, Non-invasive Mechanical Ventilator
(BIPAP, CPAP), consists of the principal Non-invasive Mechanical
Ventilator data element and two response option sub-elements: BiPAP and
CPAP. If the assessor indicates that the patient is receiving non-
invasive mechanical ventilation on the principal Non-invasive
Mechanical Ventilator data element, the assessor would then indicate
which type (BIPAP, CPAP). Data elements that assess non-invasive
mechanical ventilation are currently included on LCDS for the LTCH
setting (``Non-invasive Ventilator (BIPAP, CPAP)''), and the MDS for
the SNF setting (``Non-invasive Mechanical Ventilator (BiPAP/CPAP)'').
For more information on the Non-invasive Mechanical Ventilator data
element, we refer readers to the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs'', 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 Non-invasive Mechanical Ventilator data element was first
proposed as a standardized patient assessment data element in the CY
2018 HH PPS proposed rule (82 FR 35362 through 35363). In that proposed
rule, we stated that the proposal was informed by input we received
from August 12 to September 12, 2016 on a single data element, BiPAP/
CPAP, that captures equivalent clinical information but uses a
different label than the data element currently used in the MDS in SNFs
and LCDS in LTCHs, expressing support for this data element, noting the
feasibility of these items in PAC, and the relevance of this data
element for facilitating care coordination and supporting care
transitions. In addition, we also stated that some commenters supported
separating out BiPAP and CPAP as distinct sub-elements, as they are
therapies used for different types of patients and residents. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Non-invasive Mechanical
Ventilator data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Non-invasive Mechanical Ventilator data element was included
in the National Beta Test of candidate data elements conducted by our
data element contractor from November 2017 to August 2018. Results of
this test found the Non-invasive Mechanical Ventilator data element to
be feasible and reliable for use with PAC patients and residents. More
information about the performance of the Non-invasive Mechanical
Ventilator data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs, 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Non-invasive Mechanical Ventilator data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing non-invasive mechanical
ventilation, stakeholder input, and strong test results, we are
proposing that the Non-invasive Mechanical Ventilator (BiPAP, CPAP)
data element with a principal data element and two sub-elements meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical
Ventilator (BiPAP, CPAP) data element as standardized patient
assessment data for use in the HH QRP.
g. Respiratory Treatment: Invasive Mechanical Ventilator
    We are proposing that the Invasive Mechanical Ventilator data
element meets the definition of standardized patient assessment data
with respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35363
through 35364), 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 the complexity of the patient's underlying medical or
surgical condition. Of note, invasive mechanical ventilation is
associated with high daily and aggregate costs.\103\
---------------------------------------------------------------------------
    \103\ 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.
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    The proposed data element, Invasive Mechanical Ventilator, consists
of a
[[Page 34663]]
single data element. Data elements that capture invasive mechanical
ventilation are currently in use in the MDS in SNFs and LCDS in LTCHs.
For more information on the Invasive Mechanical Ventilator data
element, we refer readers to the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs, 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 Invasive Mechanical Ventilator data element was first proposed
as a SPADE in the CY 2018 HH PPS proposed rule (82 FR 35363 through
35364). In that proposed rule, we stated that the proposal was informed
by input we received through a call for input published on the CMS
Measures Management System Blueprint website. Input submitted on data
elements that assess invasive ventilator use and weaning status that
were tested in the PAC PRD (``Ventilator--Weaning'' and ``Ventilator--
Non-Weaning'') from August 12 to September 12, 2016 expressed support
for this data element, highlighting the importance of this information
in supporting care coordination and care transitions. We also stated
that some commenters had 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
public comments guided our decision to propose a single data element
focused on current use of invasive mechanical ventilation only, which
does not attempt to capture weaning status. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Invasive Mechanical Ventilator
data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Invasive Mechanical Ventilator data element was included in
the National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Invasive Mechanical Ventilator data element to be
feasible and reliable for use with PAC patients and residents. More
information about the performance of the Invasive Mechanical Ventilator
data element in the National Beta Test can be found in the document
titled, ``Proposed Specifications for HH QRP Quality Measures and
SPADEs, 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Invasive Mechanical Ventilator data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing invasive mechanical
ventilation, stakeholder input, and strong test results, we are
proposing that the Invasive Mechanical Ventilator data element meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Invasive Mechanical
Ventilator data element as standardized patient assessment data for use
in the HH QRP.
h. Intravenous (IV) Medications (Antibiotics, Anticoagulants,
Vasoactive Medications, Other)
    We are proposing that the IV Medications (Antibiotics,
Anticoagulants, Vasoactive Medications, Other) data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35364
through 35365), when we proposed a similar set of data elements related
to IV medications, IV medications are solutions of a specific
medication (for example, antibiotics, anticoagulants) administered
directly into the venous circulation via a syringe or intravenous
catheter. IV medications are administered via intravenous push, single,
intermittent, or continuous infusion through a tube placed into the
vein. 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 Medications data elements (Antibiotics,
Anticoagulants, Vasoactive Medications, and Other) are very different.
IV antibiotics are used for severe infections when: The bioavailability
of the oral form of the medication would be inadequate to kill the
pathogen; an oral form of the medication does not exist; or the patient
is unable to take the medication by mouth. IV anticoagulants refer to
anti-clotting medications (that is, ``blood thinners''). IV
anticoagulants are commonly used for hospitalized patients who have
deep venous thrombosis, pulmonary embolism, or myocardial infarction,
as well as those undergoing interventional cardiac procedures.
Vasoactive medications refer to the IV administration of vasoactive
drugs, including vasopressors, vasodilators, and continuous medication
for pulmonary edema, which increase or decrease blood pressure or heart
rate. 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 and residents are
receiving IV medication and the type
[[Page 34664]]
of medication provided by each PAC provider will improve quality of
care.
    The IV Medications (Antibiotics, Anticoagulants, Vasoactive
Medications, and Other) data element we are proposing consists of a
principal data element (IV Medications) and four response option sub-
elements: Antibiotics, Anticoagulants, Vasoactive Medications, and
Other. The Vasoactive Medications sub-element was not proposed in the
CY 2018 HH PPS proposed rule (82 FR 35364 through 35365). We added the
Vasoactive Medications sub-element to our proposal in order to
harmonize the proposed IV Mediciations element with the data currently
collected in the LCDS.
    If the assessor indicates that the patient is receiving IV
medications on the principal IV Medications data element, the assessor
would then indicate which types of medications (Antibiotics,
Anticoagulants, Vasoactive Medications, Other). An IV Medications data
element is currently in use on the MDS in SNFs and there is a related
data element in OASIS that collects information on Intravenous and
Infusion Therapies. For more information on the IV Medications data
element, we refer readers to the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs, 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.
    An IV Medications data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35364 through 35365). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on Vasoactive Medications from August 12 to September
12, 2016 supported this data element with one commenter noting the
importance of this data element in supporting care transitions. We also
stated that those commenters had criticized the need for collecting
specifically Vasoactive Medications, giving feedback that the data
element was too narrowly focused. In addition, public 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. A summary
report for the August 12 to September 12, 2016 public comment period
titled ``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for IV Medications data elements.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the IV Medications data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the IV Medications data element to be feasible and reliable for
use with PAC patients and residents. More information about the
performance of the IV Medications data element in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs'', 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
IV Medications data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing IV medications,
stakeholder input, and strong test results, we are proposing that the
IV Medications (Antibiotics, Anticoagulation, Vasoactive Medications,
Other) data element with a principal data element and four sub-elements
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications
(Antibiotics, Anticoagulants, Vasoactive Medications, Other) data
element as standardized patient assessment data for use in the HH QRP.
i. Transfusions
    We are proposing that the Transfusions data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35365),
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 consists of a single Transfusions data
element. A data element on transfusion is currently in use in the MDS
in SNFs (``Transfusions'') and a data element tested in the PAC PRD
(``Blood Transfusions'') was found feasible for use in each of the four
PAC settings. For more information on the Transfusions data element, we
refer readers to the
[[Page 34665]]
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs, 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 Transfusions data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35365).
    In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the special services,
treatments, and interventions data elements in general; no additional
comments were received that were specific to the Transfusions data
element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Transfusions data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Transfusions data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Transfusions data element in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs, 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Transfusions data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing transfusions,
stakeholder input, and strong test results, we are proposing that the
Transfusions data element that is currently in use in the MDS meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act and to adopt the Transfusions data
element as standardized patient assessment data for use in the HH QRP.
j. Dialysis (Hemodialysis, Peritoneal Dialysis)
    We are proposing that the Dialysis (Hemodialysis, Peritoneal
Dialysis) data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35365
through 35366), 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,
during and following each dialysis session. Nursing staff typically
perform peritoneal dialysis at the bedside, and as with hemodialysis,
close monitoring is required.
    The proposed data element, Dialysis (Hemodialysis, Peritoneal
Dialysis) consists of the principal Dialysis data element and two
response option sub-elements: Hemodialysis and Peritoneal Dialysis. If
the assessor indicates that the patient is receiving dialysis on the
principal Dialysis data element, the assessor would then indicate which
type (Hemodialysis, Peritoneal Dialysis). The principal Dialysis data
element is currently included on the MDS in SNFs and the LCDS for LTCHs
and assesses the overall use of dialysis. As the result of public
feedback described, in this proposed rule, we are proposing data
elements that include the principal Dialysis data element and two sub-
elements (Hemodialysis and Peritoneal Dialysis). For more information
on the Dialysis data element, we refer readers to the document titled,
``Proposed Specifications for HH QRP Quality Measures and SPADEs'',
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 Dialysis data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35365 through 35366). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on a singular Hemodialysis data element from August 12
to September 12, 2016 supported the assessment of hemodialysis and
recommended that the data element be expanded to include peritoneal
dialysis. We also stated that those commenters had supported the
singular 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. We also noted that
several commenters had 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
[[Page 34666]]
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. We are
proposing the expanded version of the Dialysis data element that
includes two types of dialysis. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule, we
received public comments in support of the special services,
treatments, and interventions data elements in general; no additional
comments were received that were specific to the Dialysis data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Dialysis data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Dialysis data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Dialysis data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs'', 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although they did not specifically discuss the
Dialysis data element, the TEP supported the assessment of the special
services, treatments, and interventions included in the National Beta
Test with respect to both admission and discharge. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing dialysis, stakeholder
input, and strong test results, we are proposing that the Dialysis
(Hemodialysis, Peritoneal Dialysis) data element with a principal data
element and two sub-elements meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Dialysis (Hemodialysis, Peritoneal Dialysis) data element as
standardized patient assessment data for use in the HH QRP.
k. Intravenous (IV) Access (Peripheral IV, Midline, Central Line)
    We are proposing that the IV Access (Peripheral IV, Midline,
Central Line) data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35366),
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 element 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 data element, IV Access (Peripheral IV, Midline,
Central Line), consists of the principal IV Access data element and
three response option sub-elements: Peripheral IV, Midline, and Central
Line. The proposed IV Access data element is not currently included on
any of the PAC assessment instruments, although there is a related
response option in the M1030 data element in the OASIS. We are
proposing to replace the existing ``Intravenous or Infusion Therapy''
response option of the M1030 data element in the OASIS with the IV
Access (Peripheral IV, Midline, Central Line) data element. For more
information on the IV Access data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs, 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 IV Access data element was first proposed as standardized
patient assessment data elements in the CY 2018 HH PPS proposed rule
(82 FR 35366). In that proposed rule, we stated that the proposal was
informed by input we received through a call for input published on the
CMS Measures Management System Blueprint website. Input was submitted
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. We stated that those commenters had 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
noted feasibility and importance of 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 expert input,
described elsewhere in this proposed rule, we created an overarching IV
Access data element with sub-elements for other types of IV access in
addition to central lines (that is, peripheral IV and midline). This
expanded version of IV Access is the data element being proposed. A
summary report for the
[[Page 34667]]
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the IV Access data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the IV Access data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the IV
Access data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
IV Access data element in the National Beta Test can be found in the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs, 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
IV Access data element, the TEP supported the assessment of the special
services, treatments, and interventions included in the National Beta
Test with respect to both admission and discharge. A summary of the
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel
Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present results of the National Beta
Test and solicit additional comments. General input on the testing and
item development process and concerns about burden were received from
stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing IV access, stakeholder
input, and strong test results, we are proposing that the IV access
(Peripheral IV, Midline, Central Line) data element with a principal
data element and three sub-elements meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the IV Access (Peripheral IV, Midline, Central Line)
data element as standardized patient assessment data for use in the HH
QRP.
l. Nutritional Approach: Parenteral/IV Feeding
    We are proposing that the Parenteral/IV Feeding data element meets
the definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35366
through 35367), parenteral nutrition/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 parenteral
nutrition/IV feeding indicates a clinical complexity that prevents the
patient or resident from meeting his or her nutritional needs
internally, 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's 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 proposed data element consists of the single Parenteral/IV
Feeding data element. The proposed Parenteral/IV Feeding data element
is currently in use in the MDS for SNFs, and equivalent or related data
elements are in use in the LCDS, IRF-PAI, and OASIS. We are proposing
to replace the existing ``Parenteral nutrition (TPN or lipids)''
response option of the M1030 data element in the OASIS with the
proposed 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 HH QRP Quality Measures
and SPADEs,'' 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 Parenteral/IV Feeding data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35366 through 35367). In that proposed rule, we
stated that the proposal was informed by input we received through a
call for input published on the CMS Measures Management System
Blueprint website. Input submitted on Total Parenteral Nutrition (an
item with nearly the same meaning as the proposed data element, but
with the label used in the PAC PRD), which was included in a call for
public input from August 12 to September 12, 2016. We stated that
commenters had 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 renamed Parenteral/IV Feeding, to be consistent with how this data
element is referred to in the MDS in SNFs. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment 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. In response to our proposal in
the CY 2018 HH PPS proposed rule, two commenters expressed support for
the Parenteral/IV Feeding data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Parenteral/IV Feeding data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Parenteral/IV Feeding data element to be feasible and
reliable for use with PAC patients and residents. More information
about the performance of the Parenteral/IV Feeding data element in the
National Beta Test can be found in the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs, available at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
[[Page 34668]]
Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-
of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Parenteral/IV Feeding data element, the TEP supported the assessment of
the special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing parenteral/IV feeding,
stakeholder input, and strong test results, we are proposing that the
Parenteral/IV Feeding data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Parenteral/IV Feeding data element as standardized patient
assessment data for use in the HH QRP.
m. Nutritional Approach: Feeding Tube
    We are proposing that the Feeding Tube data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35367
through 35368), 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, therefore, are important to assess
for care planning and resource use. Patients with severe malnutrition
are at higher risk for a variety of complications.\104\ In PAC
settings, there are a variety of reasons that patients and residents
may not be able to eat orally (including clinical or cognitive status).
---------------------------------------------------------------------------
    \104\ 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 consists of the single Feeding Tube data
element. The Feeding Tube data element is currently included in the MDS
for SNFs, and in the OASIS for HHAs, where it is labeled ``Enteral
Nutrition (nasogastric, gastrostomy, jejunostomy, or any other
artificial entry into the alimentary canal)''. A related data element,
collected in the IRF-PAI for IRFs (Tube/Parenteral Feeding), assesses
use of both feeding tubes and parenteral nutrition. We are proposing to
rename ``Enteral nutrition (nasogastric, gastrostomy, jejunostomy, or
any other artificial entry into the alimentary canal)'' data element to
``Feeding Tube,'' and adopt it as a SPADE for the HH QRP. For more
information on the Feeding Tube data element, we refer readers to the
document titled, ``Proposed Specifications for HH QRP Quality Measures
and SPADEs,'' 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 Feeding Tube data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35367 through 35368). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on an Enteral Nutrition data element (which is the same
as the data element we are proposing in this proposed rule, but is used
in the OASIS under a different name) from August 12 to September 12,
2016 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 summary report for
the August 12 to September 12, 2016 public comment period titled
``SPADE August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule, a
few commenters expressed support for the Feeding Tube data element. A
commenter also recommended that the term ``enteral feeding'' be used
instead of ``feeding tube.''
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Feeding Tube data element was included in the National Beta
Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Feeding Tube data element to be feasible and reliable for use
with PAC patients and residents. More information about the performance
of the Feeding Tube data element in the National Beta Test can be found
in the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Feeding Tube data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' is available at: https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-
[[Page 34669]]
2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing feeding tubes,
stakeholder input, and strong test results, we are proposing that the
Feeding Tube data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt
the Feeding Tube data element as standardized patient assessment data
for use in the HH QRP.
n. Nutritional Approach: Mechanically Altered Diet
    We are proposing that the Mechanically Altered Diet data element
meets the definition of standardized patient assessment data with
respect to special services, treatments, and interventions under
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35368), 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.\105\
---------------------------------------------------------------------------
    \105\ 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.
---------------------------------------------------------------------------
    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 and residents 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 consists of the single Mechanically
Altered Diet data element. The proposed data element for a mechanically
altered diet is currently included on the MDS for SNFs. A related data
element for modified food consistency/supervision is currently included
on the IRF-PAI for IRFs. Another related data element is included in
the OASIS for HHAs that collects information about independent eating
that requires ``a liquid, pureed or ground meat diet.'' For more
information on the Mechanically Altered Diet data element, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
Quality Measures and SPADEs, 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 Mechanically Altered Diet data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35368).
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Mechanically Altered Diet data
element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Mechanically Altered Diet data element was included in the
National Beta Test of candidate data elements conducted by our data
element contractor from November 2017 to August 2018. Results of this
test found the Mechanically Altered Diet data element to be feasible
and reliable for use with PAC patients and residents. More information
about the performance of the Mechanically Altered Diet data element in
the National Beta Test can be found in the document titled, ''Proposed
Specifications for HH QRP Quality Measures and SPADEs, 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Mechanically Altered Diet data element, the TEP supported the
assessment of the special services, treatments, and interventions
included in the National Beta Test with respect to both admission and
discharge. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing mechanically altered
diet, stakeholder input, and strong test results, we are proposing that
the Mechanically Altered Diet data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the Mechanically Altered Diet data element as
standardized patient assessment data for use in the HH QRP.
[[Page 34670]]
o. Nutritional Approach: Therapeutic Diet
    We are proposing that the Therapeutic Diet data element meets the
definition of standardized patient assessment data with respect to
special services, treatments, and interventions under section
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35368
through 35369), a therapeutic diet refers to meals planned to increase,
decrease, or eliminate specific foods or nutrients in a patient's 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 and
residents in PAC provides insight on the clinical complexity of these
patients and residents 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 proposed data element consists of the single Therapeutic Diet
data element. The Therapeutic Diet data element is currently in use in
the MDS for SNFs. For more information on the Therapeutic Diet data
element, we refer readers to the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs,'' 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 Therapeutic Diet data element was first proposed as a
standardized patient assessment data element in the CY 2018 HH PPS
proposed rule (82 FR 35368 through 35369).
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter expressed support for the Therapeutic Diet data element
and encouraged CMS to align with the Academy of Nutrition and Dietetics
definition of ``therapeutic diet.''
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Therapeutic Diet data element was included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Therapeutic Diet data element to be feasible and reliable for
use with PAC patients and residents. More information about the
performance of the Therapeutic Diet data element in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. Although the TEP did not specifically discuss the
Therapeutic Diet data element, the TEP supported the assessment of the
special services, treatments, and interventions included in the
National Beta Test with respect to both admission and discharge. A
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical
Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. A summary of the public input received from the November 27, 2018
stakeholder meeting titled ``Input on SPADEs Received After November
27, 2018 Stakeholder Meeting'' 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.
    Taking together the importance of assessing therapeutic diet,
stakeholder input, and strong test results, we are proposing that the
Therapeutic Diet data element meets the definition of standardized
patient assessment data with respect to special services, treatments,
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to
adopt the Therapeutic data element as standardized patient assessment
data for use in the HH QRP.
p. High-Risk Drug Classes: Use and Indication
    We are proposing that the High-Risk Drug Classes: Use and
Indication data element meets the definition of standardized patient
assessment data with respect to special services, treatments, and
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    Most patients and residents receiving PAC services depend on short-
and long-term medications to manage their medical conditions. However,
as a treatment, medications are not without risk; medications are in
fact a leading cause of adverse events. A study by the U.S. Department
of Health and Human Services found that 31 percent of adverse events
that occurred in 2008 among hospitalized Medicare beneficiaries were
related to medication.\106\ Moreover, changes in a patient's condition,
medications, and transitions between care settings put patients and
residents at risk of medication errors and adverse drug events (ADEs).
ADEs may be caused by medication errors such as drug omissions, errors
in dosage, and errors in dosing frequency.\107\
---------------------------------------------------------------------------
    \106\ U.S. Department of Health and Human Services. Office of
Inspector General. Daniel R. Levinson. Adverse Events in Hospitals:
National Incidence Among Medicare Beneficiaries. OEI-06-09-00090.
November 2010.
    \107\ Boockvar KS, Liu S, Goldstein N, Nebeker J, Siu A, Fried
T. Prescribing discrepancies likely to cause adverse drug events
after patient transfer. Qual Saf Health Care. 2009;18(1):32-6.
---------------------------------------------------------------------------
    ADEs are known to occur across different types of healthcare. For
example, the incidence of ADEs in the outpatient setting has been
estimated at 1.15 ADEs per 100 person-months,\108\ while the rate of
ADEs in the long-term care setting is approximately 9.80 ADEs per 100
resident-months.\109\ In the hospital setting, the incidence has been
estimated at 15 ADEs per 100 admissions.\110\ In addition,
approximately half of all hospital-related medication errors and 20
percent of ADEs occur during transitions within, admission to, transfer
to, or discharge
[[Page 34671]]
from a hospital.\111,112,113\ ADEs are more common among older adults,
who make up most patients and residents receiving PAC services. The
rate of emergency department visits for ADEs is three times higher
among adults 65 years of age and older compared to that among those
younger than age 65.\114\
---------------------------------------------------------------------------
    \108\ Gandhi TK, Seger AC, Overhage JM, et al. Outpatient
adverse drug events identified by screening electronic health
records. J Patient Saf 2010;6:91-6. doi:10.1097/
PTS.0b013e3181dcae06.
    \109\ Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR,
Cadoret C, et al. The incidence of adverse drug events in two large
academic long-term care facilities. Am J Med. 2005; 118(3):2518. Epub 2005/03/05. https://doi.org/10.1016/j.amjmed.2004.09.018. PMID: 15745723.
    \110\ Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon
C, Matheny ME, Bates DW. Occurrence of adverse, often preventable,
events in community hospitals involving nephrotoxic drugs or those
excreted by the kidney. Kidney Int. 2009; 76:1192-1198. [PubMed:
19759525]
    \111\ Barnsteiner JH. Medication reconciliation: transfer of
medication information across settings-keeping it free from error. J
Infus Nurs. 2005;28(2 Suppl):31-36.
    \112\ Rozich J, Roger, R. Medication safety: one organization's
approach to the challenge. Journal of Clinical Outcomes Management.
2001(8):27-34.
    \113\ Gleason KM, Groszek JM, Sullivan C, Rooney D, Barnard C,
Noskin GA. Reconciliation of discrepancies in medication histories
and admission orders of newly hospitalized patients. Am J Health
Syst Pharm. 2004;61(16):1689-1695.
    \114\ Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ,
Budnitz DS. US emergency department visits for outpatient adverse
drug events, 2013-2014. JAMA. doi: 10.1001/jama.2016.16201.
---------------------------------------------------------------------------
    Understanding the types of medication a patient is taking and the
reason for its use are key facets of a patient's treatment with respect
to medication. Some classes of drugs are associated with more risk than
others.\115\ We are proposing one High-Risk Drug Class data element
with six sub-elements. The six medication classes response options are:
Anticoagulants; antiplatelets; hypoglycemics (including insulin);
opioids; antipsychotics; and antibiotics. These drug classes are high-
risk due to the adverse effects that may result from use. In
particular, bleeding risk is associated with anticoagulants and
antiplatelets;116 117 fluid retention, heart failure, and
lactic acidosis are associated with hypoglycemics;\118\ misuse is
associated with opioids; \119\ fractures and strokes are associated
with antipsychotics;120 121 and various adverse events such
as central nervous systems effects and gastrointestinal intolerance are
associated with antimicrobials,\122\ the larger category of medications
that include antibiotics. Moreover, some medications in five of the six
drug classes included as response options in this data element are
included in the 2019 Updated Beers Criteria[supreg] list as potentially
inappropriate medications for use in older adults.\123\ Finally,
although a complete medication list should record several important
attributes of each medication (for example, dosage, route, stop date),
recording an indication for the drug is of crucial importance.\124\
---------------------------------------------------------------------------
    \115\ Ibid.
    \116\ Shoeb M, Fang MC. Assessing bleeding risk in patients
taking anticoagulants. J Thromb Thrombolysis. 2013;35(3):312-319.
doi: 10.1007/s11239-013-0899-7.
    \117\ Melkonian M, Jarzebowski W, Pautas E. Bleeding risk of
antiplatelet drugs compared with oral anticoagulants in older
patients with atrial fibrillation: a systematic review and
meta[hyphen]analysis. J Thromb Haemost. 2017;15:1500-1510. DOI:
10.1111/jth.13697.
    \118\ Hamnvik OP, McMahon GT. Balancing Risk and Benefit with
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New
York. 2009; 76:234-243.
    \119\ Naples JG, Gellad WF, Hanlon JT. The Role of Opioid
Analgesics in Geriatric Pain Management. Clin Geriatr Med.
2016;32(4):725-735.
    \120\ Rigler SK, Shireman TI, Cook-Wiens GJ, Ellerbeck EF,
Whittle JC, Mehr DR, Mahnken JD. Fracture risk in nursing home
residents initiating antipsychotic medications. J Am Geriatr Soc.
2013; 61(5):715-722. [PubMed: 23590366]
    \121\ Wang S, Linkletter C, Dore D et al. Age, antipsychotics,
and the risk of ischemic stroke in the Veterans Health
Administration. Stroke 2012;43:28-31. doi:10.1161/
STROKEAHA.111.617191.
    \122\ Faulkner CM, Cox HL, Williamson JC. Unique aspects of
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
    \123\ American Geriatrics Society 2019 Beers Criteria Update
Expert Panel. American Geriatrics Society 2019 Updated Beers
Criteria for Potentially Inappropriate Medication Use in Older
Adults. J Am Geriatr Soc 2019; 00:1-21. DOI: 10.1111/jgs.15767.
    \124\ Li Y, Salmasian H, Harpaz R, Chase H, Friedman C.
Determining the reasons for medication prescriptions in the EHR
using knowledge and natural language processing. AMIA Annu Symp
Proc. 2011;2011:768-76.
---------------------------------------------------------------------------
    The High-Risk Drug Classes: Use and Indication data element
requires an assessor to record whether or not a patient is taking any
medications within six drug classes. The six response options for this
data element are high-risk drug classes with particular relevance to
PAC patients and residents, as identified by our data element
contractor. The six data response options are Anticoagulants,
Antiplatelets, Hypoglycemics, Opioids, Antipsychotics, and Antibiotics.
For each drug class, the assessor is asked to indicate if the patient
is taking any medications within the class, and, for drug classes in
which medications were being taken, whether indications for all drugs
in the class are noted in the medical record. For example, for the
response option Anticoagulants, if the assessor indicates that the
patient is taking anticoagulant medication, the assessor would then
indicate if an indication is recorded in the medication record for the
anticoagulant(s).
    The High-Risk Drug Classes: Use and Indication data element that is
being proposed as a SPADE was developed as part of a larger set of data
elements to assess medication reconciliation, the process of obtaining
a patient's multiple medication lists and reconciling any
discrepancies. For more information on the High-Risk Drug Classes: Use
and Indication data element, we refer readers to the document titled,
``Proposed Specifications for HH QRP Quality Measures and SPADEs,''
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 sought public input on the relevance of conducting assessments
on medication reconciliation and specifically on the proposed High-Risk
Drug Classes: Use and Indication data element. Our data element
contractor presented data elements related to medication reconciliation
to the TEP convened on April 6 and 7, 2016. The TEP supported a focus
on high-risk drugs, because of higher potential for harm to patients
and residents, and were in favor of a data element to capture whether
or not indications for medications were recorded in the medical record.
A summary of the April 6 and 7, 2016 TEP meeting titled ``SPADE
Technical Expert Panel Summary (First Convening)'' 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. Medication reconciliation data
elements were also discussed at a second TEP meeting on January 5 and
6, 2017, convened by our data element contractor.
    At this meeting, the TEP agreed about the importance of evaluating
the medication reconciliation process, but disagreed about how this
could be accomplished through standardized assessment. The TEP also
disagreed about the usability and appropriateness of using the Beers
Criteria to identify high-risk medications,\125\ although they were
supportive of the other six drug classes named in the draft version of
the data element, which are the six drug classes being proposed as
response options in the proposed High-Risk Drug Classes: Use and
Indications SPADE. A summary of the January 5 and 6, 2017 TEP meeting
titled ``SPADE Technical Expert Panel Summary (Second Convening)'' 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.
---------------------------------------------------------------------------
    \125\ American Geriatrics Society 2015 Beers Criteria Update
Expert Panel. American Geriatrics Society. Updated Beers Criteria
for Potentially Inappropriate Medication Use in Older Adults. J Am
Geriatr Soc 2015; 63:2227-2246.
---------------------------------------------------------------------------
    We received public input on data elements related to medication
reconciliation through a call for input published on the CMS Measures
[[Page 34672]]
Management System Blueprint website. In input received from April 26 to
June 26, 2017, several commenters expressed support for the medication
reconciliation data elements that were put on display, noting the
importance of medication reconciliation in preventing medication errors
and stating that the items seemed feasible and clinically useful. A few
commenters were critical of the choice of ten drug classes posted
during that comment period--the six drug classes in the proposed SPADE,
along with antidepressants, diuretics, antianxiety, and hypnotics--
arguing that ADEs are not limited to high-risk drugs, and raised issues
related to training assessors to correctly complete a valid assessment
of medication reconciliation. A summary report for the April 26 to June
26, 2017 public comment period titled ``SPADE May-June 2017 Public
Comment 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 High-Risk Drug Classes: Use and Indication data element was
included in the National Beta Test of candidate data elements conducted
by our data element contractor from November 2017 to August 2018.
Results of this test found the High-Risk Drug Classes: Use and
Indication data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
High-Risk Drug Classes: Use and Indication data element in the National
Beta Test can be found in the document titled, ``Proposed
Specifications for HH QRP Quality Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018. The TEP acknowledged the challenges of assessing
medication safety, and were supportive of some of the data elements
focused on medication reconciliation that were tested in the National
Beta Test. The TEP was especially supportive of the focus on the six
high-risk drug classes--which they identified from among other options
during the second convening of the TEP, described previously--and of
using these classes to assess whether the indication for a drug is
recorded. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts. These
activities provided updates on the field-testing work and solicited
feedback on data elements considered for standardization, including the
High-Risk Drug Classes: Use and Indication data element. One
stakeholder group was critical of the six drug classes included as
response options in the High-Risk Drug Classes: Use and Indication data
element, noting that potentially risky medications (for example, muscle
relaxants) are not included in this list; that there may be important
differences between drugs within classes (for example, more recent
versus older style antidepressants); and that drug allergy information
is not captured. Finally, on November 27, 2018, our data element
contractor hosted a public meeting of stakeholders to present the
results of the National Beta Test and solicit additional comments.
General input on the testing and item development process and concerns
about burden were received from stakeholders during this meeting and
via email through February 1, 2019. Additionally, one commenter
questioned whether the time to complete the High-Risk Drug Classes: Use
and Indication data element would differ across settings. A summary of
the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on SPADEs Received After November 27, 2018
Stakeholder Meeting'' 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.
    Taking together the importance of assessing high-risk drugs and for
whether or not indications are noted for high-risk drugs, stakeholder
input, and strong test results, we are proposing that the High-Risk
Drug Classes: Use and Indication data element meets the definition of
standardized patient assessment data with respect to special services,
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the
Act and to adopt the High-Risk Drug Classes: Use and Indication data
element as standardized patient assessment data for use in the HH QRP.
3. Medical Condition and Comorbidity Data
    Assessing medical conditions and comorbidities is critically
important for care planning and safety for patients and residents
receiving PAC services, and the standardized assessment of selected
medical conditions and comorbidities across PAC providers is important
for managing care transitions and understanding medical complexity.
    We discuss our proposals for data elements related to the medical
condition of pain as standardized patient assessment data. Appropriate
pain management begins with a standardized assessment, and thereafter
establishing and implementing an overall plan of care that is person-
centered, multi-modal, and includes the treatment team and the patient.
Assessing and documenting the effect of pain on sleep, participation in
therapy, and other activities may provide information on undiagnosed
conditions and comorbidities and the level of care required, and do so
more objectively than subjective numerical scores. With that, we assess
that taken separately and together, these proposed data elements are
essential for care planning, consistency across transitions of care,
and identifying medical complexities, including undiagnosed conditions.
We also conclude that it is the standard of care to always consider the
risks and benefits associated with a personalized care plan, including
the risks of any pharmacological therapy, especially opioids.\126\ We
also conclude that in addition to assessing and appropriately treating
pain through the optimum mix of pharmacologic, non-pharmacologic, and
alternative therapies, while being cognizant of current prescribing
guidelines, clinicians in partnership with patients are best able to
mitigate factors that contribute to the current opioid
crisis.127 128 129
---------------------------------------------------------------------------
    \126\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \127\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \128\ Fishman SM, Carr DB, Hogans B, et al. Scope and Nature of
Pain- and Analgesia-Related Content of the United States Medical
Licensing Examination (USMLE). Pain Med Malden Mass. 2018;19(3):449-
459. doi:10.1093/pm/pnx336.
    \129\ Fishman SM, Young HM, Lucas Arwood E, et al. Core
competencies for pain management: results of an interprofessional
consensus summit. Pain Med Malden Mass. 2013;14(7):971-981.
doi:10.1111/pme.12107.
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[[Page 34673]]
    In alignment with our Meaningful Measures Initiative, accurate
assessment of medical conditions and comorbidities of patients and
residents in PAC is expected to make care safer by reducing harm caused
in the delivery of care; promoting effective prevention and treatment
of chronic disease; strengthening person and family engagement as
partners in their care; and promoting effective communication and
coordination of care. The proposed SPADEs 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. Therefore,
reliable data elements assessing medical conditions and comorbidities
are needed in order to initiate a management program that can optimize
a patient's or resident's prognosis and reduce the possibility of
adverse events.
    We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to medical
conditions and comorbidities.
a. Pain Interference (Pain Effect on Sleep, Pain Interference With
Therapy Activities, and Pain Interference With Day-to-Day Activities)
    In acknowledgement of the opioid crisis, we specifically are
seeking comment on whether or not we should add these pain items in
light of those concerns. Commenters should address to what extent
collection of the data through patient queries might encourage
providers to prescribe opioids.
    We are proposing that a set of three data elements on the topic of
Pain Interference (Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities) meet the
definition of standardized patient assessment data with respect to
medical conditions and comorbidities under section 1899B(b)(1)(B)(iv)
of the Act.
    The practice of pain management began to undergo significant
changes in the 1990s because the inadequate, non-standardized, non-
evidence-based assessment and treatment of pain became a public health
issue.\130\ In pain management, a critical part of providing
comprehensive care is performance of a thorough initial evaluation,
including assessment of both the medical and any biopsychosocial
factors causing or contributing to the pain, with a treatment plan to
address the causes of pain and to manage pain that persists over
time.\131\ Quality pain management, based on current guidelines and
evidence-based practices, can minimize unnecessary opioid prescribing
both by offering alternatives or supplemental treatment to opioids and
by clearly stating when they may be appropriate, and how to utilize
risk-benefit analysis for opioid and non-opioid treatment
modalities.\132\
---------------------------------------------------------------------------
    \130\ Institute of Medicine. Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education, and
Research. Washington (DC): National Academies Press (US); 2011.
http://www.ncbi.nlm.nih.gov/books/NBK91497/.
    \131\ Department of Health and Human Services: Pain Management
Best Practices Inter-Agency Task Force. Draft Report on Pain
Management Best Practices: Updates, Gaps, Inconsistencies, and
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \132\ National Academies. Pain Management and the Opioid
Epidemic: Balancing Societal and Individual Benefits and Risks of
Prescription Opioid Use. Washington DC: National Academies of
Sciences, Engineering, and Medicine; 2017.
---------------------------------------------------------------------------
    Pain is not a surprising symptom in PAC patients and residents,
where healing, recovery, and rehabilitation often require regaining
mobility and other functions after an acute event. Standardized
assessment of pain that interferes with function is an important first
step toward appropriate pain management in PAC settings. The National
Pain Strategy called for refined assessment items on the topic of pain,
and describes the need for these improved measures to be implemented in
PAC assessments.\133\ Further, the focus on pain interference, as
opposed to pain intensity or pain frequency, was supported by the TEP
convened by our data element contractor as an appropriate and
actionable metric for assessing pain. A summary of the September 17,
2018 TEP meeting titled ``SPADE Technical Expert Panel Summary (Third
Convening)'' 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.
---------------------------------------------------------------------------
    \133\ National Pain Strategy: A Comprehensive Population-Health
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
---------------------------------------------------------------------------
    We appreciate the important concerns related to the misuse and
overuse of opioids in the treatment of pain and to that end we note
that in this proposed rule we have also proposed a SPADE that assess
for the use of, as well as importantly the indication for that use of,
high risk drugs, including opioids. Further, in the CY 2017 HH PPS
final rule (81 FR 76780) we adopted the Drug Regimen Review Conducted
With Follow-Up for Identified Issues--Post Acute Care (PAC) HH QRP
measure, which assesses whether PAC providers were responsive to
potential or actual clinically significant medication issue(s)
including issues associated with use and misuse of opioids for pain
management, when such issues were identified.
    We also note that the proposed SPADEs related to pain assessment
are not associated with any particular approach to management. Since
the use of opioids is associated with serious complications,
particularly in the elderly, an array of successful non-pharmacologic
and non-opioid approaches to pain management may be considered.\134\
\135\ \136\ PAC providers have historically used a range of pain
management strategies, including non-steroidal anti-inflammatory drugs,
ice, transcutaneous electrical nerve stimulation (TENS) therapy,
supportive devices, acupuncture, and the like. In addition, non-
pharmacological interventions implemented for pain management include,
but are not limited to, biofeedback, application of heat/cold, massage,
physical therapy, nerve block, stretching and strengthening exercises,
chiropractic, electrical stimulation, radiotherapy, and
ultrasound.\137\ \138\ \139\
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    \134\ Chau, D.L., Walker, V., Pai, L., & Cho, L.M. (2008).
Opiates and elderly: use and side effects. Clinical interventions in
aging, 3(2), 273-8.
    \135\ Fine, P.G. (2009). Chronic Pain Management in Older
Adults: Special Considerations. Journal of Pain and Symptom
Management, 38(2): S4-S14.
    \136\ Solomon, D.H., Rassen, J.A., Glynn, R.J., Garneau, K.,
Levin, R., Lee, J., & Schneeweiss, S. (2010). Archives Internal
Medicine, 170(22):1979-1986.
    \137\ Byrd L. Managing chronic pain in older adults: a long-term
care perspective. Annals of Long-Term Care: Clinical Care and Aging.
2013;21(12):34-40.
    \138\ Kligler, B., Bair, M.J., Banerjea, R. et al. (2018).
Clinical Policy Recommendations from the VHA State-of-the-Art
Conference on Non-Pharmacological Approaches to Chronic
Musculoskeletal Pain. Journal of General Internal Medicine, 33(Suppl
1): 16. https://doi.org/10.1007/s11606-018-4323-z.
    \139\ Chou, R., Deyo, R., Friedly, J., et al. (2017).
Nonpharmacologic Therapies for Low Back Pain: A Systematic Review
for an American College of Physicians Clinical Practice Guideline.
Annals of Internal Medicine, 166(7):493-505.
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    We believe that standardized assessment of pain interference will
support PAC clinicians in applying best-practices in pain management
for chronic and acute pain, consistent with current clinical
guidelines. For example,
[[Page 34674]]
the standardized assessment of both opioids and pain interference would
support providers in successfully tapering patients/residents who
arrive in the PAC setting with long-term use of opioids onto non-
pharmacologic treatments and non-opioid medications, as recommended by
the Society for Post-Acute and Long-Term Care Medicine,\140\ and
consistent with HHS's 5-Point Strategy To Combat the Opioid Crisis
\141\ which includes ``Better Pain Management.''
---------------------------------------------------------------------------
    \140\ Society for Post-Acute and Long-Term Care Medicine (AMDA).
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
    \141\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html.
---------------------------------------------------------------------------
    The Pain Interference data element set consists of three data
elements: Pain Effect on Sleep, Pain Interference with Therapy
Activities, and Pain Interference with Day-to-Day Activities. Pain
Effect on Sleep assesses the frequency with which pain affects a
patient's sleep. Pain Interference with Therapy Activities assesses the
frequency with which pain interferes with a patient's ability to
participate in therapies. The Pain Interference with Day-to-Day
Activities assesses the extent to which pain interferes with a
patient's ability to participate in day-to-day activities excluding
therapy.
    A similar data element on the effect of pain on activities is
currently included in the OASIS. A similar data element on the effect
on sleep is currently included in the MDS instrument in SNFs. We are
proposing to add the Pain Interference data element set (Pain Effect on
Sleep, Pain Interference with Therapy Activities, and Pain Interference
with Day-to-Day Activities) to the OASIS and to remove M1242, Frequency
of Pain Interfering with Patient's Activity or Movement. For more
information on the Pain Interference data elements, we refer readers to
the document titled, ``Proposed Specifications for HH QRP Quality
Measures and SPADEs,'' 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 sought public input on the relevance of conducting assessments
on pain and specifically on the larger set of Pain Interview data
elements included in the National Beta Test. The proposed data elements
were supported by comments from the TEP meeting held by our data
element contractor on April 7 to 8, 2016. The TEP affirmed the
feasibility and clinical utility of pain as a concept in a standardized
assessment. The TEP agreed that data elements on pain interference with
ability to participate in therapies versus other activities should be
addressed. Further, during a more recent convening of the same TEP on
September 17, 2018, the TEP supported the interview-based pain data
elements included in the National Beta Test. The TEP members were
particularly supportive of the items that focused on how pain
interferes with activities (that is, Pain Interference data elements)
because understanding the extent to which pain interferes with function
would enable clinicians to determine the need for appropriate pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 held a public comment period in 2016 to solicit feedback on the
standardization of pain and several other items that were under
development in prior efforts, through a call for input published on the
CMS Measures Management System Blueprint website. From the prior public
comment period, we included several pain data elements (Pain Effect on
Sleep; Pain Interference--Therapy Activities; Pain Interference--Other
Activities) in a second call for public comment, also published on the
CMS Measures Management System Blueprint website, open from April 26 to
June 26, 2017. The items we sought comment on were modified from all
stakeholder and test efforts. Commenters provided general comments
about pain assessment in general in addition to feedback on the
specific pain items. A few commenters shared their support for
assessing pain, the potential for pain assessment to improve the
quality of care, and for the validity and reliability of the data
elements. Commenters affirmed that the item of pain and the effect on
sleep would be suitable for PAC settings. Commenters' main concerns
included redundancy with existing data elements, feasibility and
utility for cross-setting use, and the applicability of interview-based
items to patients and residents with cognitive or communication
impairments, and deficits. A summary report for the April 26 to June
26, 2017 public comment period titled ``SPADE May-June 2017 Public
Comment 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 Pain Interference data elements were included in the National
Beta Test of candidate data elements conducted by our data element
contractor from November 2017 to August 2018. Results of this test
found the Pain Interference data elements to be feasible and reliable
for use with PAC patients and residents. More information about the
performance of the Pain Interference data elements in the National Beta
Test can be found in the document titled, ``Proposed Specifications for
HH QRP Quality Measures and SPADEs,'' 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.
    In addition, our data element contractor convened a TEP on
September 17, 2018 for the purpose of soliciting input on the proposed
standardized patient assessment data elements. The TEP supported the
interview-based pain data elements included in the National Beta Test.
The TEP members were particularly supportive of the items that focused
on how pain interferes with activities (that is, Pain Interference data
elements), because understanding the extent to which pain interferes
with function would enable clinicians to determine the need for pain
treatment. A summary of the September 17, 2018 TEP meeting titled
``SPADE Technical Expert Panel Summary (Third Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, one commenter expressed strong support for the
proposed pain SPADEs and was encouraged by the fact
[[Page 34675]]
that this portion of the assessment surpasses pain presence. A summary
of the public input received from the November 27, 2018 stakeholder
meeting titled ``Input on SPADEs Received After November 27, 2018
Stakeholder Meeting'' 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.
    Taking together the importance of assessing the effect of pain on
function, stakeholder input, and strong test results, we are proposing
that the set of Pain Interference data elements (Pain Effect on Sleep,
Pain Interference with Therapy Activities, and Pain Interference with
Day-to-Day Activities) meet the definition of standardized patient
assessment data with respect to medical conditions and comorbidities
under section 1899B(b)(1)(B)(iv) of the Act and to adopt the Pain
Interference data elements (Pain Effect on Sleep, Pain Interference
with Therapy Activities, and Pain Interference with Day-to-Day
Activities) as standardized patient assessment data for use in the HH
QRP.
4. 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 and
residents will require more intensive and prolonged treatment. Onset of
these conditions can be gradual, so individualized assessment with
accurate screening tools and follow-up evaluations are essential to
determining which patients and residents 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 or
resident'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 and residents continue to have their vision and
hearing needs met when they leave the facility. In addition, entities
that receive Federal financial assistance, such as through Medicare
Parts A, C, and D, must take appropriate steps to ensure effective
communication for individuals with disabilities, including provision of
appropriate auxiliary aids and services.\142\
---------------------------------------------------------------------------
    \142\ Section 504 of the Rehabilitation Act of 1973, section1557
of the Affordable Care Act, and their respective implementing
regulations. More information is available at: https://www.hhs.gov/civil-rights/for-individuals/disability/index.html, and https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html.
---------------------------------------------------------------------------
    In alignment with our Meaningful Measures Initiative, we expect
accurate individualized assessment, treatment, and accommodation of
hearing and vision impairments of patients and residents in PAC to make
care safer by reducing harm caused in the delivery of care; promoting
effective prevention and treatment of chronic disease; strengthening
person and family engagement as partners in their care; and promoting
effective communication and coordination of care. 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. Therefore, reliable data
elements assessing hearing and vision impairments are needed to
initiate a management program that can optimize a patient's or
resident's prognosis and reduce the possibility of adverse events.
    Comments on the category of impairments were also submitted by
stakeholders during the CY 2018 HH PPS proposed rule (82 FR 35369
through 35371) public comment period. We received public comments
regarding the Hearing and Vision data elements; no additional comments
were received about impairments in general.
    We are inviting comment on our proposals to collect as standardized
patient assessment data the following data with respect to impairments.
a. Hearing
    We are proposing that the Hearing data element meets the definition
of standardized patient assessment data with respect to impairments
under section 1899B(b)(1)(B)(v) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35369
through 35370), 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.143 144 Treatment and accommodation of hearing
impairment led to improved health outcomes, including but not limited
to quality of life.\145\ For example, hearing loss in elderly
individuals has been associated with depression and cognitive
impairment,146 147 148 higher rates of incident cognitive
impairment and cognitive decline,\149\ and less time in occupational
therapy.\150\ Accurate assessment of hearing impairment is important in
the PAC setting for care planning and defining resource use.
---------------------------------------------------------------------------
    \143\ 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.
    \144\ 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.
    \145\ 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.
    \146\ 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.
    \147\ 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.
    \148\ 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.
    \149\ 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.
    \150\ 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 consists of the single Hearing data
element. This data consists of one question that assesses level of
hearing impairment. This data element is currently in use in the MDS in
SNFs. For more information on the Hearing data element, we refer
readers to the document titled, ``Proposed Specifications for HH QRP
[[Page 34676]]
Quality Measures and SPADEs'', 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 Hearing data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35369 through 35370). In that proposed rule, we stated that the
proposal was informed by input we received through a call for input
published on the CMS Measures Management System Blueprint website.
Input submitted on the PAC PRD form of the data element (``Ability to
Hear'') from August 12 to September 12, 2016, recommended that hearing,
vision, and communication assessments be administered at the beginning
of patient assessment process. A summary report for the August 12 to
September 12, 2016 public comment period titled ``SPADE August 2016
Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter noted that resources would be needed for a change in the
OASIS to account for the Hearing data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Hearing data element was included in the National Beta Test
of candidate data elements conducted by our data element contractor
from November 2017 to August 2018. Results of this test found the
Hearing data element to be feasible and reliable for use with PAC
patients and residents. More information about the performance of the
Hearing data element in the National Beta Test can be found in the
document titled, ''Proposed Specifications for HH QRP Quality Measures
and SPADEs, 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.
    In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs,
including the Hearing data element. The TEP affirmed the importance of
standardized assessment of hearing impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Hearing data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on SPADEs
Received After November 27, 2018 Stakeholder Meeting'' 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.
    Due to the relatively stable nature of hearing impairment, we are
proposing that HHAs that submit the Hearing data element with respect
to SOC will be deemed to have submitted with respect to discharge.
Taking together the importance of assessing hearing, stakeholder input,
and strong test results, we are proposing that the Hearing data element
meets the definition of standardized patient assessment data with
respect to impairments under section 1899B(b)(1)(B)(v) of the Act and
to adopt the Hearing data element as standardized patient assessment
data for use in the HH QRP.
b. Vision
    We are proposing that the Vision data element meets the definition
of standardized patient assessment data with respect to impairments
under section 1899B(b)(1)(B)(v) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35370
through 35371), evaluation of an individual's ability to see is
important for assessing 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
residents 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.151 152 153 154 155 156 157 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. 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 HH setting for care planning and
defining resource use.
---------------------------------------------------------------------------
    \151\ 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.
    \152\ 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.
    \153\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh.
2004;36(1):79-85.
    \154\ 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.
    \155\ 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.
    \156\ Rovner BW, Ganguli M. Depression and disability associated
with impaired vision: the MoVies Project. J Am Geriatr Soc.
1998;46(5):617-619.
    \157\ 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.
---------------------------------------------------------------------------
    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. The Vision data element that we are proposing
for standardization was tested as part of the development of the MDS
for SNFs and is currently in use in that assessment. A similar data
element, but with different wording and fewer response option
categories, is in use in the OASIS. We are proposing to add the Vision
(Ability to See in Adequate Light) data element to the OASIS to replace
M1200, Vision. For more information on the Vision data element, we
refer readers to the document titled, ``Proposed
[[Page 34677]]
Specifications for HH QRP Quality Measures and SPADEs,'' 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 Vision data element was first proposed as a standardized
patient assessment data element in the CY 2018 HH PPS proposed rule (82
FR 35370 through 35371). In that proposed rule, we stated that the
proposal was informed by input we received 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) through a call
for input published on the CMS Measures Management System Blueprint
website. The data element on which we solicited input differed from the
proposed data element, but input submitted from August 12 to September
12, 2016 supported the assessment of vision in PAC settings and the
useful information a vision data element would provide. We also stated
that commenters had noted 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. A summary report for the
August 12 to September 12, 2016 public comment period titled ``SPADE
August 2016 Public Comment 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.
    In response to our proposal in the CY 2018 HH PPS proposed rule,
one commenter noted that resources would be needed for a change in the
OASIS to account for the Vision data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed
rule, the Vision data element was included in the National Beta Test of
candidate data elements conducted by our data element contractor from
November 2017 to August 2018. Results of this test found the Vision
data element to be feasible and reliable for use with PAC patients and
residents. More information about the performance of the Vision data
element in the National Beta Test can be found in the document titled,
``Proposed Specifications for HH QRP Quality Measures and SPADEs,''
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.
    In addition, our data element contractor convened a TEP on January
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs
including the Vision data element. The TEP affirmed the importance of
standardized assessment of vision impairment in PAC patients and
residents. A summary of the January 5 and 6, 2017 TEP meeting titled
``SPADE Technical Expert Panel Summary (Second Convening)'' 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 also held Special Open Door Forums and small-group discussions
with PAC providers and other stakeholders in 2018 for the purpose of
updating the public about our ongoing SPADE development efforts.
Finally, on November 27, 2018, our data element contractor hosted a
public meeting of stakeholders to present the results of the National
Beta Test and solicit additional comments. General input on the testing
and item development process and concerns about burden were received
from stakeholders during this meeting and via email through February 1,
2019. Additionally, a commenter expressed support for the Vision data
element and suggested administration at the beginning of the patient
assessment to maximize utility. A summary of the public input received
from the November 27, 2018 stakeholder meeting titled ``Input on SPADEs
Received After November 27, 2018 Stakeholder Meeting'' 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.
    Due to the relatively stable nature of vision impairment, we are
proposing that HHAs that submit the Vision data element with respect to
SOC will be deemed to have submitted with respect to discharge. Taking
together the importance of assessing vision, stakeholder input, and
strong test results, we are proposing that the Vision data element
meets the definition of standardized patient assessment data with
respect to impairments under section 1899B(b)(1)(B)(v) of the Act and
to adopt the Vision data element as standardized patient assessment
data for use in the HH QRP.
5. Proposed New Category: Social Determinants of Health
a. Proposed Social Determinants of Health Data Collection To Inform
Measures and Other Purposes
    Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS
to assess appropriate adjustments to quality measures, resource
measures, and other measures, and to assess and implement appropriate
adjustments to payment under Medicare based on those measures, after
taking into account studies conducted by ASPE on social risk factors
(described elsewhere in this proposed rule) and other information, and
based on an individual's health status and other factors. Subparagraph
(C) of section 2(d)(2) of the IMPACT Act further requires the Secretary
to carry out periodic analyses, at least every three years, based on
the factors referred to subparagraph (A) so as to monitor changes in
possible relationships. Subparagraph (B) of section 2(d)(2) of the
IMPACT Act requires CMS to collect or otherwise obtain access to data
necessary to carry out the requirement of the paragraph (both assessing
adjustments described previously in such subparagraph (A) and for
periodic analyses in such subparagraph (C)). Accordingly we are
proposing to use our authority under subparagraph (B) of section
2(d)(2) of the IMPACT Act to establish a new data source for
information to meet the requirements of subparagraphs (A) and (C) of
section 2(d)(2). In this rule, we are proposing to collect and access
data about social determinants of health (SDOH) in order to perform
CMS' responsibilities under subparagraphs (A) and (C) of section
2(d)(2) of the IMPACT Act, as explained in more detail elsewhere in
this proposed rule. Social determinants of health, also known as social
risk factors, or health-related social needs, are the socioeconomic,
cultural and environmental circumstances in which individuals live that
impact their health. We are proposing to collect information on seven
proposed SDOH SPADE data elements relating to race, ethnicity,
preferred language, interpreter services, health literacy,
transportation, and
[[Page 34678]]
social isolation; a detailed discussion of each of the proposed SDOH
data elements is found in section IV.A.7.f.(ii). of this proposed rule.
    We are also proposing to use the OASIS, the current version being
OASIS-D, described as the PAC assessment instrument for home health
agencies under section 1899B(a)(2)(B)(i) of the Act, to collect these
data via an existing data collection mechanism. We believe this
approach will provide CMS with access to data with respect to the
requirements of section 2(d)(2) of the IMPACT Act, while minimizing the
reporting burden on PAC health care providers by relying on a data
reporting mechanism already used and an existing system to which PAC
providers are already accustomed.
    The IMPACT Act includes several requirements applicable to the
Secretary, in addition to those imposing new data reporting obligations
on certain PAC providers as discussed in section IV.A.7.f.(2). of this
proposed rule. Subparagraphs (A) and (B) of section 2(d)(1) of the
IMPACT Act require the Secretary, acting through the Office of the
Assistant Secretary for Planning and Evaluation (ASPE), to conduct two
studies that examine the effect of risk factors, including individuals'
socioeconomic status, on quality, resource use and other measures under
the Medicare program. The first ASPE study was completed in December
2016 and is discussed in this proposed rule, and the second study is to
be completed in the fall of 2019. We recognize that ASPE, in its
studies, is considering a broader range of social risk factors than the
SDOH data elements in this proposal, and address both PAC and non-PAC
settings. We acknowledge that other data elements may be useful to
understand, and that some of those elements may be of particular
interest in non-PAC settings. For example, for beneficiaries receiving
care in the community, as opposed to an in-patient facility, housing
stability and food insecurity may be more relevant. We will continue to
take into account the findings from both of ASPE's reports in future
policy making.
    One of the ASPE's first actions under the IMPACT Act was to
commission the National Academies of Sciences, Engineering and Medicine
(NASEM) to define and conceptualize socioeconomic status for the
purposes of ASPE's two studies under section 2(d)(1) of the IMPACT Act.
The NASEM convened a panel of experts in the field and conducted an
extensive literature review. Based on the information collected, the
2016 NASEM panel report titled, ``Accounting for Social Risk Factors in
Medicare Payment: Identifying Social Risk Factors,'' concluded that the
best way to assess how social processes and social relationships
influence key health-related outcomes in Medicare beneficiaries is
through a framework of social risk factors instead of socioeconomic
status. Social risk factors discussed in the NASEM report include
socioeconomic position, race, ethnicity, gender, social context, and
community context. These factors are discussed at length in chapter 2
of the NASEM report, entitled ``Social Risk Factors.'' \158\
Consequently NASEM framed the results of its report in terms of
``social risk factors'' rather than ``socioeconomic status'' or
``sociodemographic status.'' The full text of the ``Social Risk
Factors'' NASEM report is available for reading on the website at
https://www.nap.edu/read/21858/chapter/1.
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    \158\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Chapter 2. Washington, DC: The
National Academies Press.
---------------------------------------------------------------------------
    Each of the data elements we are proposing to collect and access
pursuant to our authority under section 2(d)(2)(B) of the IMPACT Act is
identified in the 2016 NASEM report as a social risk factor that has
been shown to impact care use, cost and outcomes for Medicare
beneficiaries. CMS uses the term social determinants of health (SDOH)
to denote social risk factors, which is consistent with the objectives
of Healthy People 2020.\159\
---------------------------------------------------------------------------
    \159\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
---------------------------------------------------------------------------
    ASPE issued its first Report to Congress, entitled ``Social Risk
Factors and Performance Under Medicare's Value-Based Purchasing
Programs,'' under section 2(d)(1)(A) of the IMPACT Act on December 21,
2016.\160\ Using NASEM's social risk factors framework, ASPE focused on
the following social risk factors, in addition to disability: (1) Dual
enrollment in Medicare and Medicaid as a marker for low income; (2)
residence in a low-income area; (3) Black race; (4) Hispanic ethnicity;
and (5) residence in a rural area. ASPE acknowledged that the social
risk factors examined in its report were limited due to data
availability. The report also noted that the data necessary to
meaningfully attempt to reduce disparities and identify and reward
improved outcomes for beneficiaries with social risk factors have not
been collected consistently on a national level in post-acute care
settings. Where these data have been collected, the collection
frequently involves lengthy questionnaires. More information on the
Report to Congress on Social Risk Factors and Performance under
Medicare's Value-Based Purchasing Programs, including the full report,
is available on the website at https://aspe.hhs.gov/social-risk-factors-and-medicares-value-based-purchasing-programs-reports.
---------------------------------------------------------------------------
    \160\ U.S. Department of Health and Human Services, Office of
the Assistant Secretary for Planning and Evaluation. 2016. Report to
Congress: Social Risk Factors and Performance Under Medicare's
Value-Based Payment Programs. Washington, DC.
---------------------------------------------------------------------------
    Section 2(d)(2) of the IMPACT Act relates to CMS activities and
imposes several responsibilities on the Secretary relating to quality,
resource use, and other measures under Medicare. As mentioned
previously, under of subparagraph (A) of section 2(d)(2) of the IMPACT
Act, the Secretary is required, on an ongoing basis, taking into
account the ASPE studies and other information, and based on an
individual's health status and other factors, to assess appropriate
adjustments to quality, resource use, and other measures, and to assess
and implement appropriate adjustments to Medicare payments based on
those measures. Section 2(d)(2)(A)(i) of the IMPACT Act applies to
measures adopted under subsections (c) and (d) of section 1899B of the
Act and to other measures under Medicare. However, our ability to
perform these analyses, and assess and make appropriate adjustments is
hindered by limits of existing data collections on SDOH data elements
for Medicare beneficiaries. In its first study in 2016, in discussing
the second study, ASPE noted that information related to many of the
specific factors listed in the IMPACT Act, such as health literacy,
limited English proficiency, and Medicare beneficiary activation, are
not available in Medicare data.
    Subparagraph 2(d)(2)(A) of the IMPACT Act specifically requires the
Secretary to take the studies and considerations from ASPE's reports to
Congress, as well as other information as appropriate, into account in
assessing and implementing adjustments to measures and related payments
based on measures in Medicare. The results of the ASPE's first study
demonstrated that Medicare beneficiaries with social risk factors
tended to have worse outcomes on many quality measures, and providers
who treated a disproportionate share of beneficiaries with social risk
factors tended to have worse performance on quality measures. As a
result of these findings, ASPE
[[Page 34679]]
suggested a three-pronged strategy to guide the development of value-
based payment programs under which all Medicare beneficiaries receive
the highest quality healthcare services possible. The three components
of this strategy are to: (1) Measure and report quality of care for
beneficiaries with social risk factors; (2) set high, fair quality
standards for care provided to all beneficiaries; and (3) reward and
support better outcomes for beneficiaries with social risk factors. In
discussing how measuring and reporting quality for beneficiaries with
social risk factors can be applied to Medicare quality payment
programs, the report offered nine considerations across the three-
pronged strategy, including enhancing data collection and developing
statistical techniques to allow measurement and reporting of
performance for beneficiaries with social risk factors on key quality
and resource use measures.
    Congress, in section 2(d)(2)(B) of the IMPACT Act, required the
Secretary to collect or otherwise obtain access to the data necessary
to carry out the provisions of paragraph (2) of section 2(d)(2) of the
IMPACT Act through both new and existing data sources. Taking into
consideration NASEM's conceptual framework for social risk factors
discussed previously, ASPE's study, and considerations under section
2(d)(1)(A) of the IMPACT Act, as well as the current data constraints
of ASPE's first study and its suggested considerations, we are
proposing to collect and access data about SDOH under section 2(d)(2)
of the IMPACT Act. Our collection and use of the SDOH data described in
section IV.A.7.f.(i). of this proposed rule, under section 2(d)(2) of
the IMPACT Act, would be independent of our proposal (in section
IV.A.7.f.(2). of this proposed rule) and our authority to require
submission of that data for use as SPADE under section 1899B(a)(1)(B)
of the Act.
    Accessing standardized data relating to the SDOH data elements on a
national level is necessary to permit CMS to conduct periodic analyses,
to assess appropriate adjustments to quality measures, resource use
measures, and other measures, and to assess and implement appropriate
adjustments to Medicare payments based on those measures. We agree with
ASPE's observations, in the value-based purchasing context, that the
ability to measure and track quality, outcomes, and costs for
beneficiaries with social risk factors over time is critical as
policymakers and providers seek to reduce disparities and improve care
for these groups. Collecting the data as proposed will provide the
basis for our periodic analyses of the relationship between an
individual's health status and other factors and quality, resource, and
other measures, as required by section 2(d)(2) of the IMPACT Act, and
to assess appropriate adjustments. These data would also permit us to
develop the statistical tools necessary to maximize the value of
Medicare data, reduce costs and improve the quality of care for all
beneficiaries. Collecting and accessing SDOH data in this way also
supports the three-part strategy put forth in the first ASPE report,
specifically ASPE's consideration to enhance data collection and
develop statistical techniques to allow measurement and reporting of
performance for beneficiaries with social risk factors on key quality
and resource use measures.
    For the reasons discussed previously, we are proposing under
section 2(d)(2) of the IMPACT Act, to collect the data on the following
SDOH: (1) Race, as described in section V.G.5.b.(1). of this proposed
rule; (2) Ethnicity, described in section V.G.5.b.(1). of this proposed
rule; (3) Preferred Language, as described in section V.G.5.(ii).(2).
of this proposed rule; (4) Interpreter Services, as described in
section V.G.5.b.(2). of this proposed rule; (5) Health Literacy, as
described in section V.G.5.b.(3). of this proposed rule; (6)
Transportation, as described in section V.G.5.(ii).(4). of this
proposed rule; and (7) Social Isolation, as described in section
V.G.5.b.(5). of this proposed rule. These data elements are discussed
in more detail in section V.G.5. of this proposed rule.
b. Standardized Patient Assessment Data
    Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to
collect SPADEs with respect to other categories deemed necessary and
appropriate. We are proposing to create a Social Determinants of Health
SPADE category under section 1899B(b)(1)(B)(vi) of the Act. In addition
to collecting SDOH data for the purposes outlined previously, under
section 2(d)(2)(B), we are also proposing to collect as SPADE these
same data elements (race, ethnicity, preferred language, interpreter
services, health literacy, transportation, and social isolation) under
section 1899B(b)(1)(B)(vi) of the Act. We believe that this proposed
new category of Social Determinants of Health will inform provider
understanding of individual patient risk factors and treatment
preferences, facilitate coordinated care and care planning, and improve
patient outcomes. We are proposing to deem this category necessary and
appropriate, for the purposes of SPADE, because using common standards
and definitions for PAC data elements is important in ensuring
interoperable exchange of longitudinal information between PAC
providers and other providers to facilitate coordinated care,
continuity in care planning, and the discharge planning process from
post-acute care settings.
    All of the Social Determinants of Health data elements we are
proposing under section 1899B(b)(1)(B)(vi) of the Act have the capacity
to take into account treatment preferences and care goals of patients
and to inform our understanding of patient complexity and risk factors
that may affect care outcomes. While acknowledging the existence and
importance of additional SDOH, we are proposing to assess some of the
factors relevant for patients receiving post-acute care that PAC
settings are in a position to impact through the provision of services
and supports, such as connecting patients with identified needs with
transportation programs, certified interpreters, or social support
programs.
    As previously mentioned, and described in more detail elsewhere in
this proposed rule, we are proposing to adopt the following seven data
elements as SPADE under the proposed Social Determinants of Health
category: Race, ethnicity, preferred language, interpreter services,
health literacy, transportation, and social isolation. To select these
data elements, we reviewed the research literature, a number of
validated assessment tools and frameworks for addressing SDOH currently
in use (for example, Health Leads, NASEM, Protocol for Responding to
and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), and
ICD-10), and we engaged in discussions with stakeholders. We also
prioritized balancing the reporting burden for PAC providers with our
policy objective to collect SPADEs that will inform care planning and
coordination and quality improvement across care settings. Furthermore,
incorporating SDOH data elements into care planning has the potential
to reduce readmissions and help beneficiaries achieve and maintain
their health goals.
    We also considered feedback received during a listening session
that we held on December 13, 2018. The purpose of the listening session
was to solicit feedback from health systems, research organizations,
advocacy organizations, state agencies, and other members of the public
on collecting patient-level data on SDOH across care settings,
including consideration of race, ethnicity, spoken
[[Page 34680]]
language, health literacy, social isolation, transportation, sex,
gender identity, and sexual orientation. We also gave participants an
option to submit written comments. A full summary of the listening
session, titled ``Listening Session on Social Determinants of Health
Data Elements: Summary of Findings,'' includes a list of participating
stakeholders and their affiliations, and 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.
(1) Race and Ethnicity
    The persistence of racial and ethnic disparities in health and
health care is widely documented, including in PAC
settings.161 162 163 164 165 Despite the trend toward
overall improvements in quality of care and health outcomes, the Agency
for Healthcare Research and Quality, in its National Healthcare Quality
and Disparities Reports, consistently indicates that racial and ethnic
disparities persist, even after controlling for factors such as income,
geography, and insurance.\166\ For example, racial and ethnic
minorities tend to have higher rates of infant mortality, diabetes and
other chronic conditions, and visits to the emergency department, and
lower rates of having a usual source of care and receiving
immunizations such as the flu vaccine.\167\ Studies have also shown
that African Americans are significantly more likely than white
Americans to die prematurely from heart disease and stroke.\168\
However, our ability to identify and address racial and ethnic health
disparities has historically been constrained by data limitations,
particularly for smaller populations groups such as Asians, American
Indians and Alaska Natives, and Native Hawaiians and other Pacific
Islanders.\169\
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    \161\ 2017 National Healthcare Quality and Disparities Report.
Rockville, MD: Agency for Healthcare Research and Quality; September
2018. AHRQ Pub. No. 18-0033-EF.
    \162\ Fiscella, K. and Sanders, M.R. Racial and Ethnic
Disparities in the Quality of Health Care. (2016). Annual Review of
Public Health. 37:375-394.
    \163\ 2018 National Impact Assessment of the Centers for
Medicare & Medicaid Services (CMS) Quality Measures Reports.
Baltimore, MD: U.S. Department of Health and Human Services, Centers
for Medicare and Medicaid Services; February 28, 2018.
    \164\ Smedley, B.D., Stith, A.Y., & Nelson, A.R. (2003). Unequal
treatment: confronting racial and ethnic disparities in health care.
Washington, DC, National Academy Press.
    \165\ Chase, J., Huang, L. and Russell, D. (2017). Racial/ethnic
disparities in disability outcomes among post-acute home care
patients. J of Aging and Health. 30(9):1406-1426.
    \166\ National Healthcare Quality and Disparities Reports.
(December 2018). Agency for Healthcare Research and Quality,
Rockville, MD. http://www.ahrq.gov/research/findings/nhqrdr/index.html.
    \167\ National Center for Health Statistics. Health, United
States, 2017: With special feature on mortality. Hyattsville,
Maryland. 2018.
    \168\ HHS. Heart disease and African Americans. 2016b. (October
24, 2016). http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
    \169\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A, Negussie Y, Geller A,
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
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    The ability to improve understanding of and address racial and
ethnic disparities in PAC outcomes requires the availability of better
data. There is currently a Race and Ethnicity data element, collected
in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single
question, which aligns with the 1997 Office of Management and Budget
(OMB) minimum data standards for federal data collection efforts.\170\
The 1997 OMB Standard lists five minimum categories of race: (1)
American Indian or Alaska Native; (2) Asian; (3) Black or African
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White.
The 1997 OMB Standard also lists two minimum categories of ethnicity:
(1) Hispanic or Latino; and (2) Not Hispanic or Latino. The 2011 HHS
Data Standards requires a two-question format when self-identification
is used to collect data on race and ethnicity. Large federal surveys
such as the National Health Interview Survey, Behavioral Risk Factor
Surveillance System, and the National Survey on Drug Use and Health,
have implemented the 2011 HHS race and ethnicity data standards. CMS
has similarly updated the Medicare Current Beneficiary Survey, Medicare
Health Outcomes Survey, and the Health Insurance Marketplace
Application for Health Coverage with the 2011 HHS data standards. More
information about the HHS Race and Ethnicity Data Standards are
available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
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    \170\ ``Revisions to the Standards for the Classification of
Federal Data on Race and Ethnicity (Notice of Decision)''. Federal
Register 62:210 (October 30, 1997) pp. 58782-58790. Available from:
https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf.
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    We are proposing to revise the current Race and Ethnicity data
element for purposes of this proposal to conform to the 2011 HHS Data
Standards for person-level data collection, while also meeting the 1997
OMB minimum data standards for race and ethnicity. Rather than one data
element that assesses both race and ethnicity, we are proposing two
separate data elements: One for Race and one for Ethnicity, that would
conform with the 2011 HHS Data Standards and the 1997 OMB Standard. In
accordance with the 2011 HHS Data Standards, a two-question format
would be used for the proposed race and ethnicity data elements.
    The proposed Race data element asks, ``What is your race?'' We are
proposing to include 14 response options under the race data element:
(1) White; (2) Black or African American; (3) American Indian or Alaska
Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7) Japanese; (8)
Korean; (9) Vietnamese; (10) Other Asian; (11) Native Hawaiian; (12)
Guamanian or Chamorro; (13) Samoan; and, (14) Other Pacific Islander.
    The proposed Ethnicity data element asks, ``Are you Hispanic,
Latino/a, or Spanish origin?'' We are proposing to include five
response options under the ethnicity data element: (1) Not of Hispanic,
Latino/a, or Spanish origin; (2) Mexican, Mexican American, Chicano;
(3) Puerto Rican; (4) Cuban; and (5) Another Hispanic, Latino, or
Spanish Origin.
    We believe that the two proposed data elements for race and
ethnicity conform to the 2011 HHS Data Standards for person-level data
collection, while also meeting the 1997 OMB minimum data standards for
race and ethnicity, because under those standards, more detailed
information on population groups can be collected if those additional
categories can be aggregated into the OMB minimum standard set of
categories.
    In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the importance of improving response
options for race and ethnicity as a component of health care
assessments and for monitoring disparities. Some stakeholders
emphasized the importance of allowing for self-identification of race
and ethnicity for more categories than are included in the 2011 HHS
Standard to better reflect state and local diversity, while
acknowledging the burden of coding an open-ended health care assessment
question across different settings.
    We believe that the proposed modified race and ethnicity data
elements more accurately reflect the diversity of the U.S. population
than the
[[Page 34681]]
current race/ethnicity data element included in MDS, LCDS, IRF-PAI, and
OASIS.171 172 173 174 We believe, and research consistently
shows, that improving how race and ethnicity data are collected is an
important first step in improving quality of care and health outcomes.
Addressing disparities in access to care, quality of care, and health
outcomes for Medicare beneficiaries begins with identifying and
analyzing how SDOH, such as race and ethnicity, align with disparities
in these areas.\175\ Standardizing self-reported data collection for
race and ethnicity allows for the equal comparison of data across
multiple healthcare entities.\176\ By collecting and analyzing these
data, CMS and other healthcare entities will be able to identify
challenges and monitor progress. The growing diversity of the U.S.
population and knowledge of racial and ethnic disparities within and
across population groups supports the collection of more granular data
beyond the 1997 OMB minimum standard for reporting categories. The 2011
HHS race and ethnicity data standard includes additional detail that
may be used by PAC providers to target quality improvement efforts for
racial and ethnic groups experiencing disparate outcomes. For more
information on the Race and Ethnicity data elements, we refer readers
to the document titled ``Proposed Specifications for HH QRP Measures
and Standardized Patient Assessment Data Elements,'' 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.
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    \171\ Penman-Aguilar, A., Talih, M., Huang, D., Moonesinghe, R.,
Bouye, K., Beckles, G. (2016). Measurement of Health Disparities,
Health Inequities, and Social Determinants of Health to Support the
Advancement of Health Equity. J Public Health Manag Pract. 22 Suppl
1: S33-42.
    \172\ Ramos, R., Davis, J.L., Ross, T., Grant, C.G., Green, B.L.
(2012). Measuring health disparities and health inequities: Do you
have REGAL data? Qual Manag Health Care. 21(3):176-87.
    \173\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
    \174\ ``Revision of Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity: Proposals From
Federal Interagency Working Group (Notice and Request for
Comments).'' Federal Register 82: 39 (March 1, 2017) p. 12242.
    \175\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Population Health and Public
Health Practice; Committee on Community-Based Solutions to Promote
Health Equity in the United States; Baciu A. Negussie Y. Geller A.
et al., editors. Communities in Action: Pathways to Health Equity.
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The
State of Health Disparities in the United States. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
    \176\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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    In an effort to standardize the submission of race and ethnicity
data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in
section 1899B(a)(1)(B) of the Act, while minimizing the reporting
burden, we are proposing to adopt the Race and Ethnicity data elements
described previously as SPADEs with respect to the proposed Social
Determinants of Health category.
    Specifically, we are proposing to replace the current Race/
Ethnicity data element, M0140, with the proposed Race and Ethnicity
data elements. Due to the stable nature of Race/Ethnicity, we are
proposing that HHAs that submit the Race and Ethnicity SPADEs with
respect to SOC only will be deemed to have submitted those SPADEs with
respect to SOC, ROC, and discharge, because it is unlikely that the
assessment of those SPADEs with respect to SOC will differ from the
assessment of the same SPADES with respect to ROC and discharge.
(2) Preferred Language and Interpreter Services
    More than 64 million Americans speak a language other than English
at home, and nearly 40 million of those individuals have limited
English proficiency (LEP).\177\ Individuals with LEP have been shown to
receive worse care and have poorer health outcomes, including higher
readmission rates.178 179 180 Communication with individuals
with LEP is an important component of high quality health care, which
starts by understanding the population in need of language services.
Unaddressed language barriers between a patient and provider care team
negatively affects the ability to identify and address individual
medical and non-medical care needs, to convey and understand clinical
information, as well as discharge and follow up instructions, all of
which are necessary for providing high quality care. Understanding the
communication assistance needs of patients with LEP, including
individuals who are Deaf or hard of hearing, is critical for ensuring
good outcomes.
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    \177\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
    \178\ Karliner LS, Kim SE, Meltzer DO, Auerbach AD. Influence of
language barriers on outcomes of hospital care for general medicine
inpatients. J Hosp Med. 2010 May-Jun;5(5):276-82. doi: 10.1002/
jhm.658.
    \179\ Kim EJ, Kim T, Paasche-Orlow MK, et al. Disparities in
Hypertension Associated with Limited English Proficiency. J Gen
Intern Med. 2017 Jun;32(6):632-639. doi: 10.1007/s11606-017-3999-9.
    \180\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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    Presently, the preferred language of patients and need for
interpreter services are assessed in two PAC assessment tools. The LCDS
and the MDS use the same two data elements to assess preferred language
and whether a patient or resident needs or wants an interpreter to
communicate with health care staff. The MDS initially implemented
preferred language and interpreter services data elements to assess the
needs of SNF residents and patients and inform care planning. For
alignment purposes, the LCDS later adopted the same data elements for
LTCHs. The 2009 NASEM (formerly Institute of Medicine) report on
standardizing data for health care quality improvement emphasizes that
language and communication needs should be assessed as a standard part
of health care delivery and quality improvement strategies.\181\
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    \181\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press.
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    In developing our proposal for a standardized language data element
across PAC settings, we considered the current preferred language and
interpreter services data elements that are in LCDS and MDS. We also
considered the 2011 HHS Primary Language Data Standard and peer-
reviewed research. The current preferred language data element in LCDS
and MDS asks, ``What is your preferred language?'' Because the
preferred language data element is open-ended, the patient is able to
identify their preferred language, including American Sign Language
(ASL). Finally, we considered the recommendations from the 2009 NASEM
(formerly Institute of Medicine) report, ``Race, Ethnicity, and
Language Data: Standardization for Health Care Quality Improvement.''
In it, the committee recommended that organizations evaluating a
patient's language and communication needs for health care purposes,
should collect data on the preferred spoken language and on an
individual's assessment of his/her level of English proficiency.
    A second language data element in LCDS and MDS asks, ``Do you want
or need an interpreter to communicate with a doctor or health care
staff?'' and
[[Page 34682]]
includes yes or no response options. In contrast, the 2011 HHS Primary
Language Data Standard recommends either a single question to assess
how well someone speaks English or, if more granular information is
needed, a two-part question to assess whether a language other than
English is spoken at home and if so, identify that language. However,
neither option allows for a direct assessment of a patient's preferred
spoken or written language nor whether they want or need interpreter
services for communication with a doctor or care team, both of which
are an important part of assessing patient needs and the care planning
process. More information about the HHS Data Standard for Primary
Language is available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
    Research consistently recommends collecting information about an
individual's preferred spoken language and evaluating those responses
for purposes of determining language access needs in health care.\182\
However, using ``preferred spoken language'' as the metric does not
adequately account for people whose preferred language is ASL, which
would necessitate adopting an additional data element to identify
visual language. The need to improve the assessment of language
preferences and communication needs across PAC settings should be
balanced with the burden associated with data collection on the
provider and patient. Therefore we are proposing to use the Preferred
Language and Interpreter Services data elements currently in use on the
MDS and LCDS, on the OASIS.
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    \182\ Guerino, P. and James, C. Race, Ethnicity, and Language
Preference in the Health Insurance Marketplaces 2017 Open Enrollment
Period. Centers for Medicare & Medicaid Services, Office of Minority
Health. Data Highlight: Volume 7--April 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
---------------------------------------------------------------------------
    In addition, we received feedback during the December 13, 2018
listening session on the importance of evaluating and acting on
language preferences early to facilitate communication and allowing for
patient self-identification of preferred language. Although the
discussion about language was focused on preferred spoken language,
there was general consensus among participants that stated language
preferences may or may not accurately indicate the need for interpreter
services, which supports collecting and evaluating data to determine
language preference, as well as the need for interpreter services. An
alternate suggestion was made to inquire about preferred language
specifically for discussing health or health care needs. While this
suggestion does allow for ASL as a response option, we do not have data
indicating how useful this question might be for assessing the desired
information and thus we are not including this question in our
proposal.
    Improving how preferred language and need for interpreter services
data are collected is an important component of improving quality by
helping PAC providers and other providers understand patient needs and
develop plans to address them. For more information on the Preferred
Language and Interpreter Services data elements, we refer readers to
the document titled ``Proposed Specifications for HH QRP Measures and
Standardized Patient Assessment Data Elements,'' available on the
website 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.
    In an effort to standardize the submission of language data among
IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the Preferred Language and Interpreter Services
data elements currently used on the LCDS and MDS, and described
previously, as SPADES with respect to the Social Determinants of Health
category.
(3) Health Literacy
    The Department of Health and Human Services defines health literacy
as ``the degree to which individuals have the capacity to obtain,
process, and understand basic health information and services needed to
make appropriate health decisions.'' \183\ Similar to language
barriers, low health literacy can interfere with communication between
the provider and patient and the ability for patients or their
caregivers to understand and follow treatment plans, including
medication management. Poor health literacy is linked to lower levels
of knowledge about health, worse health outcomes, and the receipt of
fewer preventive services, but higher medical costs and rates of
emergency department use.\184\
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    \183\ U.S. Department of Health and Human Services, Office of
Disease Prevention and Health Promotion. National action plan to
improve health literacy. Washington (DC): Author; 2010.
    \184\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for social risk factors in Medicare payment:
Identifying social risk factors. Washington, DC: The National
Academies Press.
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    Health literacy is prioritized by Healthy People 2020 as an
SDOH.\185\ Healthy People 2020 is a long-term, evidence-based effort
led by the Department of Health and Human Services that aims to
identify nationwide health improvement priorities and improve the
health of all Americans. Although not designated as a social risk
factor in NASEM's 2016 report on accounting for social risk factors in
Medicare payment, the NASEM report noted that Health literacy is
impacted by other social risk factors and can affect access to care as
well as quality of care and health outcomes.\186\ Assessing for health
literacy across PAC settings would facilitate better care coordination
and discharge planning. A significant challenge in assessing the health
literacy of individuals is avoiding excessive burden on patients and
health care providers. The majority of existing, validated health
literacy assessment tools use multiple screening items, generally with
no fewer than four, which would make them burdensome if adopted in MDS,
LCDS, IRF-PAI, and OASIS.
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    \185\ Social Determinants of Health. Healthy People 2020.
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
    \186\ U.S. Department of Health & Human Services, Office of the
Assistant Secretary for Planning and Evaluation. Report to Congress:
Social Risk Factors and Performance Under Medicare's Value-Based
Purchasing Programs. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs. Washington, DC: 2016.
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    The Single Item Literacy Screener (SILS) question asks, ``How often
do you need to have someone help you when you read instructions,
pamphlets, or other written material from your doctor or pharmacy?''
Possible response options are: (1) Never; (2) Rarely; (3) Sometimes;
(4) Often; and (5) Always. The SILS question, which assesses reading
ability (a primary component of health literacy), tested reasonably
well against the 36 item Short Test of Functional Health Literacy in
Adults (S-TOFHLA), a thoroughly vetted and widely adopted health
literacy test, in assessing the likelihood of low health literacy in an
adult sample from primary care practices participating in the Vermont
Diabetes Information System.187 188 The S-TOFHLA is a more
[[Page 34683]]
complex assessment instrument developed using actual hospital related
materials such as prescription bottle labels and appointment slips, and
often considered the instrument of choice for a detailed evaluation of
health literacy.\189\ Furthermore, the S-TOFHLA instrument is
proprietary and subject to purchase for individual entities or
users.\190\ Given that SILS is publicly available, shorter and easier
to administer than the full health literacy screen, and research found
that a positive result on the SILS demonstrates an increased likelihood
that an individual has low health literacy, we are proposing to use the
single-item reading question for health literacy in the standardized
data collection across PAC settings. We believe that use of this data
element will provide sufficient information about the health literacy
of HH patients to facilitate appropriate care planning, care
coordination, and interoperable data exchange across PAC settings.
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    \187\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B.
(2006). The Single Item Literacy Screener: evaluation of a brief
instrument to identify limited reading ability. BMC family practice,
7, 21. doi:10.1186/1471-2296-7-21.
    \188\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer,
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or
two-item literacy screener to predict the S-TOFHLA among adult
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
    \189\ University of Miami, School of Nursing & Health Studies,
Center of Excellence for Health Disparities Research. Test of
Functional Health Literacy in Adults (TOFHLA). (March 2019).
Available from: https://elcentro.sonhs.miami.edu/research/measures-library/tofhla/index.html.
    \190\ Nurss, J.R., Parker, R.M., Williams, M.V., &Baker, D.W.
David W. (2001). TOFHLA. Peppercorn Books & Press. Available from:
http://www.peppercornbooks.com/catalog/information.php?info_id=5.
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    In addition, we received feedback during the December 13, 2018 SDOH
listening session on the importance of recognizing health literacy as
more than understanding written materials and filling out forms, as it
is also important to evaluate whether patients understand their
conditions. However, the NASEM recently recommended that health care
providers implement health literacy universal precautions instead of
taking steps to ensure care is provided at an appropriate literacy
level based on individualized assessment of health literacy.\191\ Given
the dearth of Medicare data on health literacy and gaps in addressing
health literacy in practice, we recommend the addition of a health
literacy data element.
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    \191\ Hudson, S., Rikard, R.V., Staiculescu, I. & Edison, K.
(2017). Improving health and the bottom line: The case for health
literacy. In Building the case for health literacy: Proceedings of a
workshop. Washington, DC: The National Academies Press.
---------------------------------------------------------------------------
    The proposed Health Literacy data element is consistent with
considerations raised by NASEM and other stakeholders and research on
health literacy, which demonstrates an impact on health care use, cost,
and outcomes.\192\ For more information on the proposed Health Literacy
data element, we refer readers to the document titled ``Proposed
Specifications for HH QRP Measures and Standardized Patient Assessment
Data Elements,'' available on the website 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.
---------------------------------------------------------------------------
    \192\ National Academies of Sciences, Engineering, and Medicine.
2016. Accounting for Social Risk Factors in Medicare Payment:
Identifying Social Risk Factors. Washington, DC: The National
Academies Press.
---------------------------------------------------------------------------
    In an effort to standardize the submission of health literacy data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the SILS question, described previously for the
Health Literacy data element, as SPADE under the Social Determinants of
Health category. We are proposing to add the Health Literacy data
element to the OASIS.
(4) Transportation
    Transportation barriers commonly affect access to necessary health
care, causing missed appointments, delayed care, and unfilled
prescriptions, all of which can have a negative impact on health
outcomes.\193\ Access to transportation for ongoing health care and
medication access needs, particularly for those with chronic diseases,
is essential to successful chronic disease management. Adopting a data
element to collect and analyze information regarding transportation
needs across PAC settings would facilitate the connection to programs
that can address identified needs. We are therefore proposing to adopt
as SPADE a single transportation data element that is from the Protocol
for Responding to and Assessing Patients' Assets, Risks, and
Experiences (PRAPARE) assessment tool and currently part of the
Accountable Health Communities (AHC) Screening Tool.
---------------------------------------------------------------------------
    \193\ Syed, S.T., Gerber, B.S., and Sharp, L.K. (2013).
Traveling Towards Disease: Transportation Barriers to Health Care
Access. J Community Health. 38(5): 976-993.
---------------------------------------------------------------------------
    The proposed Transportation data element from the PRAPARE tool
asks, ``Has a lack of transportation kept you from medical
appointments, meetings, work, or from getting things needed for daily
living?'' The three response options are: (1) Yes, it has kept me from
medical appointments or from getting my medications; (2) Yes, it has
kept me from non-medical meetings, appointments, work, or from getting
things that I need; and (3) No. The patient would be given the option
to select all responses that apply. We are proposing to use the
transportation data element from the PRAPARE Tool, with permission from
National Association of Community Health Centers (NACHC), after
considering research on the importance of addressing transportation
needs as a critical SDOH.\194\
---------------------------------------------------------------------------
    \194\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.www.aha.org/transportation.
---------------------------------------------------------------------------
    The proposed data element is responsive to research on the
importance of addressing transportation needs as a critical SDOH and
would adopt the Transportation item from the PRAPARE tool.\195\ This
data element comes from the national PRAPARE social determinants of
health assessment protocol, developed and owned by NACHC, in
partnership with the Association of Asian Pacific Community Health
Organization, the Oregon Primary Care Association, and the Institute
for Alternative Futures. Similarly the Transportation data element used
in the AHC Screening Tool was adapted from the PRAPARE tool. The AHC
screening tool was implemented by the Center for Medicare and Medicaid
Innovation's AHC Model and developed by a panel of interdisciplinary
experts that looked at evidence-based ways to measure SDOH, including
transportation. While the transportation access data element in the AHC
screening tool serves the same purposes as our proposed SPADE
collection about transportation barriers, the AHC tool has binary yes
or no response options that do not differentiate between challenges for
medical versus non-medical appointments and activities. We believe that
this is an important nuance for informing PAC discharge planning to a
community setting, as transportation needs for non-medical activities
may differ than for medical activities and should be taken into
account.\196\ We believe that use of this data element will provide
sufficient information about transportation barriers to medical and
non-medical care for HH patients to facilitate appropriate discharge
planning and care coordination across PAC
[[Page 34684]]
settings. As such, we are proposing to adopt the Transportation data
element from PRAPARE. More information about development of the PRAPARE
tool is available on the website at https://protect2.fireeye.com/url?k=7cb6eb44-20e2f238-7cb6da7b-0cc47adc5fa2-1751cb986c8c2f8c&u=http://www.nachc.org/prapare.
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    \195\ Health Research & Educational Trust. (2017, November).
Social determinants of health series: Transportation and the role of
hospitals. Chicago, IL. Available at www.aha.org/transportation.
    \196\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------
    In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the impact of transportation
barriers on unmet care needs. While recognizing that there is no
consensus in the field about whether providers should have
responsibility for resolving patient transportation needs, discussion
focused on the importance of assessing transportation barriers to
facilitate connections with available community resources.
    Adding a Transportation data element to the collection of SPADE
would be an important step to identifying and addressing SDOH that
impact health outcomes and patient experience for Medicare
beneficiaries. For more information on the Transportation data element,
we refer readers to the document titled ``Proposed Specifications for
HH QRP Measures and Standardized Patient Assessment Data Elements,''
available on the website 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.
    In an effort to standardize the submission of transportation data
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we
are proposing to adopt the Transportation data element described
previously as SPADE with respect to the proposed Social Determinants of
Health category. If finalized as proposed, we would add the
Transportation data element to the OASIS.
(5) Social Isolation
    Distinct from loneliness, social isolation refers to an actual or
perceived lack of contact with other people, such as living alone or
residing in a remote area.197 198 Social isolation tends to
increase with age, is a risk factor for physical and mental illness,
and a predictor of mortality.199 200 201 Post-acute care
providers are well-suited to design and implement programs to increase
social engagement of patients, while also taking into account
individual needs and preferences. Adopting a data element to collect
and analyze information about social isolation for patients receiving
HH services and across PAC settings would facilitate the identification
of patients who are socially isolated and who may benefit from
engagement efforts.
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    \197\ Tomaka, J., Thompson, S., and Palacios, R. (2006). The
Relation of Social Isolation, Loneliness, and Social Support to
Disease Outcomes Among the Elderly. J of Aging and Health. 18(3):
359-384.
    \198\ Social Connectedness and Engagement Technology for Long-
Term and Post-Acute Care: A Primer and Provider Selection Guide.
(2019). Leading Age. Available at https://www.leadingage.org/white-papers/social-connectedness-and-engagement-technology-long-term-and-post-acute-care-primer-and#1.1.
    \199\ Landeiro, F., Barrows, P., Nuttall Musson, E., Gray, A.M.,
and Leal, J. (2017). Reducing Social Loneliness in Older People: A
Systematic Review Protocol. BMJ Open. 7(5): e013778.
    \200\ Ong, A.D., Uchino, B.N., and Wethington, E. (2016).
Loneliness and Health in Older Adults: A Mini-Review and Synthesis.
Gerontology. 62:443-449.
    \201\ Leigh-Hunt, N., Bagguley, D., Bash, K., Turner, V.,
Turnbull, S., Valtorta, N., and Caan, W. (2017). An overview of
systematic reviews on the public health consequences of social
isolation and loneliness. Public Health. 152:157-171.
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    We are proposing to adopt as SPADE a single social isolation data
element that is currently part of the AHC Screening Tool. The AHC item
was selected from the Patient-Reported Outcomes Measurement Information
System (PROMIS[supreg]) Item Bank on Emotional Distress, and asks,
``How often do you feel lonely or isolated from those around you?'' The
five response options are: (1) Never; (2) Rarely; (3) Sometimes; (4)
Often; and (5) Always.\202\ The AHC Screening Tool was developed by a
panel of interdisciplinary experts that looked at evidence-based ways
to measure SDOH, including social isolation. More information about the
AHC Screening Tool is available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
---------------------------------------------------------------------------
    \202\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------
    In addition, we received stakeholder feedback during the December
13, 2018 SDOH listening session on the value of receiving information
on social isolation for purposes of care planning. Some stakeholders
also recommended assessing social isolation as an SDOH as opposed to
social support.
    The proposed Social Isolation data element is consistent with NASEM
considerations about social isolation as a function of social
relationships that impacts health outcomes and increases mortality
risk, as well as the current work of a NASEM committee examining how
social isolation and loneliness impact health outcomes in adults 50
years and older. We believe that adding a Social Isolation data element
would be an important component of better understanding patient
complexity and the care goals of patients, thereby facilitating care
coordination and continuity in care planning across PAC settings. For
more information on the Social Isolation data element, we refer readers
to the document titled ``Proposed Specifications for HH QRP Measures
and Standardized Patient Assessment Data Elements,'' available on the
website 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.
    In an effort to standardize the submission of data about social
isolation among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined
in section 1899B(a)(1)(B) of the Act, while minimizing the reporting
burden, we are proposing to adopt the Social Isolation data element
described previously as SPADE with respect to the proposed Social
Determinants of Health category. We are proposing to add the Social
Isolation data element to the OASIS.
J. Proposed Codification of the Home Health Quality Reporting Program
Requirements
    To promote alignment of the HH QRP and the SNF QRP, IRF QRP, and
LTCH QRP regulatory text, we believe that with the exception of the
provision governing the 2 percentage point reduction to the update of
the unadjusted national standardized prospective payment rate, it is
appropriate to codify the requirements that apply to the HH QRP in a
single section of our regulations. Accordingly, we are proposing to
amend 42 CFR chapter IV, subchapter G by creating a new Sec.  484.245,
titled ``Home Health Quality Reporting Program''.
    The provisions we are proposing to codify are as follows:
     The HH QRP participation requirements at Sec.  484.245(a)
(72 FR 49863).
     The HH QRP data submission requirements at Sec.
484.245(b)(1), including--
    ++ Data on measures specified under section 1899B(c)(1) and
1899B(d)(1) of the Act;
    ++ Standardized patient assessment data required under section
1899B(b)(1) of the Act (82 FR 51735 through 51736); and
    ++ Quality data specified under section 1895(b)(3)(B)(v)(II) of the
Act including the HHCAHPS survey data submission requirements at Sec.
484.245(b)(1)(iii)(A) through (E)
[[Page 34685]]
(redesignated from Sec.  484.250(b) through (c)(3) and striking Sec.
484.250(a)(2)).
     The HH QRP data submission form, manner, and timing
requirements at Sec.  484.245(b)(2).
     The HH QRP exceptions and extension requirements at Sec.
484.245(c) (redesignated from Sec.  484.250(d)(1) through (d)(4)(ii)).
     The HH QRP's reconsideration policy at Sec.  484.245(d)
(redesignated from Sec.  484.250(e)(1) through (4)).
     The HH QRP appeals policy at Sec.  484.245(e)
(redesignated from Sec.  484.250(f)).
    We also note the following codification proposals:
     The addition of the HHCAHPS and HH QRP acronyms to the
definitions at Sec.  484.205.
     The removal of the regulatory provision in Sec.
484.225(b) regarding the unadjusted national prospective 60-day episode
rate for HHAs that submit their quality data as specified by the
Secretary.
     The redesignation of the regulatory provision in Sec.
484.225(c) to Sec.  484.225(b) regarding the unadjusted national
prospective 60-day episode rate for HHAs that do not submit their
quality data as specified by the Secretary.
     The redesignation of the regulatory provision in Sec.
484.225(d) to Sec.  484.225(c) regarding the national, standardized
prospective 30-day payment amount. The cross-reference in newly
redesignated paragraph (c) would also be revised.
K. Home Health Care Consumer Assessment of Healthcare Providers and
Systems (CAHPS[supreg]) Survey (HHCAHPS)
    We are proposing to remove Question 10 from all HHCAHPS Surveys
(both mail surveys and telephone surveys) which says, ``In the last 2
months of care, did you and a home health provider from this agency
talk about pain?'' which is one of seven questions (they are questions
3, 4, 5, 10, 12, 13 and 14) in the ``Special Care Issues'' composite
measure, beginning July 1, 2020. The ``Special Care Issues'' composite
measure also focuses on home health agency staff discussing home
safety, the purpose of the medications that are being taken, side
effects of medications, and when to take medications. In the initial
development of the HHCAHPS Survey, this question was included in the
survey since home health agency staff talk about pain to identify any
emerging issues (for example, wounds that are getting worse) every time
they see their home health patients.
    We are proposing to remove pain questions from the HHCAHPS Survey
and pain items from the OASIS data sets to avoid potential unintended
consequences that may arise from their inclusion in CMS surveys and
datasets. The reason that CMS is proposing removing this particular
pain question is consistent with the proposed removal of pain items
from OASIS in section IV.D.1. of this proposed rule and also consistent
with the removal of pain items from the Hospital CAHPS Survey. The
removal of pain questions from CMS surveys and removal of pain items
from CMS data sets is to avoid potential unintended consequences that
arise from their inclusion in CMS surveys and datasets. We welcome
comments about the proposed removal of Q10 from the HHCAHPS Survey. In
the initial development of the HHCAHPS Survey, this question was
included in the survey, and, consequently, from the ``Special Care
Issues'' measure. The HHCAHPS Survey is available on the official
website for HHCAHPS, at https://homehealthcahps.org.
I. Form, Manner, and Timing of Data Submission Under the HH QRP
1. Background
    Section 484.250(a), requires HHAs to submit OASIS data and Home
Health Care Consumer Assessment of Healthcare Providers and Systems
Survey (HHCAHPS) data to meet the quality reporting requirements of
section 1895(b)(3)(B)(v) of the Act. Not all OASIS data described in
Sec.  484.55(b) and (d) are necessary for purposes of complying with
the quality reporting requirements of section 1895(b)(3)(B)(v) of the
Act. OASIS data items may be used for other purposes unrelated to the
HH QRP, including payment, survey and certification, the HH VBP Model,
or care planning. Any OASIS data that are not submitted for the
purposes of the HH QRP are not used for purposes of determining HH QRP
compliance.
2. Proposed Schedule for Reporting the Transfer of Health Information
Quality Measures Beginning With the CY 2022 HH QRP
    As discussed in section V.E. of this proposed rule, we are
proposing to adopt the Transfer of Health Information to Provider-Post-
Acute Care (PAC) and Transfer of Health Information to Patient-Post-
Acute Care (PAC) quality measures beginning with the CY 2022 HH QRP. We
are also proposing that HHAs would report the data on those measures
using the OASIS. We are proposing that HHAs would be required to
collect data on both measures for patients beginning with patients
discharged or transferred on or after January 1, 2021. HHAs would be
required to report these data for the CY 2022 HH QRP at discharge and
transfer between January 1, 2021 and June 30, 2021. Following the
initial reporting period for the CY 2022 HH QRP, subsequent years for
the HH QRP would be based on 12 months of such data reporting beginning
with July 1, 2021 through June 30, 2022 for the CY 2023 HH QRP.
3. Proposed Schedule for Reporting Standardized Patient Assessment Data
Elements Beginning With the CY 2022 HH QRP
    As discussed in section V.G. of this proposed rule, we are
proposing to adopt additional SPADEs beginning with the CY 2022 HH QRP.
We are proposing that HHAs would report the data using the OASIS. HHAs
would be required to collect the SPADEs for episodes beginning or
ending on or after January 1, 2021. We are also proposing that HHAs
that submit the Hearing, Vision, Race, and Ethnicity SPADEs with
respect to SOC will be deemed to have submitted those SPADEs with
respect to SOC, ROC, and discharge, because it is unlikely that the
assessment of those SPADEs with respect to SOC will differ from the
assessment of the same SPADES with respect to ROC or discharge. HHAs
would be required to report the remaining SPADES for the CY 2022 HH QRP
at SOC, ROC, and discharge time points between January 1, 2021 and June
30, 2021. Following the initial reporting period for the CY 2022 HH
QRP, subsequent years for the HH QRP would be based on 12 months of
such data reporting beginning with July 1, 2021 through June 30, 2022
for the CY 2023 HH QRP.
4. Input Sought To Expand the Reporting of OASIS Data Used for the HH
QRP To Include Data on All Patients Regardless of Their Payer
    We continue to believe that the reporting of all-payer data under
the HH QRP would add value to the program and provide a more accurate
representation of the quality provided by HHA's. In the CY 2018 HH PPS
final rule (82 FR 51736 through 51737), we received and responded to
comments sought for data reporting related to assessment based
measures, specifically on whether we should require quality data
reporting on all HH patients, regardless of payer, where feasible.
Several commenters supported data collection of all patients regardless
of payer but other commenters did express concerns about the burden
imposed on the HHAs as a result of OASIS reporting
[[Page 34686]]
for all patients, including healthcare professionals spending more time
with documentation and less time providing patient care, and the need
to increase staff hours or hire additional staff. A commenter requested
CMS provide additional explanation of what the benefit would be to
collecting OASIS data on all patients regardless of payer.
    We are sensitive to the issue of burden associated with data
collection and acknowledge concerns about the additional burden
required to collect quality data on all patients. We are aware that
while some providers use a separate assessment for private payers, many
HHA's currently collect OASIS data on all patients regardless of payer
to assist with clinical and work flow implications associated with
maintaining two distinct assessments. We believe collecting OASIS data
on all patients regardless of payer will allow us to ensure data that
is representative of quality provided to all patients in the HHA
setting and therefore, allow us to better determine whether HH Medicare
beneficiaries receive the same quality of care that other patients
receive. We also believe it is the overall goal of the IMPACT Act to
standardize data and measures in the four PAC programs to permit
longitudinal analysis of the data. The absence of all payer data limits
CMS's ability to compare all patients receiving services in each PAC
setting, as was intended by the Act.
    We plan to propose to expand the reporting of OASIS data used for
the HH QRP to include data on all patients, regardless of their payer,
in future rulemaking. Collecting data on all HHA patients, regardless
of their payer would align our data collection requirements under the
HH QRP with the data collection requirements currently adopted for the
Long-Term Care Hospital (LTCH) QRP and the Hospice QRP. Additionally,
collection of data on all patients, regardless of their payer is
currently being proposed in the FY 2020 rules for the Skilled Nursing
Facility (SNF) QRP (84 FR 17678 through 17679) and the Inpatient
Rehabilitation Facilities (IRF) QRP (84 FR 17326 through 17327). To
assist us regarding a future proposal, we are seeking input on the
following questions related to requiring quality data reporting on all
HH patients, regardless of payer:
     Do you agree there is a need to collect OASIS data for the
HH QRP on all patients regardless of payer?
     What percentage of your HHA's patients are you not
currently reporting OASIS data for the HH QRP?
     Are there burden issues that need to be considered
specific to the reporting of OASIS data on all HH patients, regardless
of their payer?
     What differences, if any, do you notice in patient mix or
in outcomes between those patients that you currently report OASIS
data, and those patients that you do not report data for the HH QRP?
     Are there other factors that should be considered prior to
proposing to expand the reporting of OASIS data used for the HH QRP to
include data on all patients, regardless of their payer?
    As stated previously, there is no proposal in this rule to expand
the reporting of OASIS data used for the HH QRP to include data on all
HHA patients regardless of payer. However we look forward to receiving
comments on this topic, including the questions noted previously, and
will take all recommendations received into consideration.
VI. Medicare Coverage of Home Infusion Therapy Services
A. Background and Overview
1. Background
    Section 5012 of the 21st Century Cures Act (``the Cures Act'')
(Pub. L. 114-255), which amended sections 1861(s)(2) and 1861(iii) of
the Act, established a new Medicare home infusion therapy benefit. The
Medicare home infusion therapy benefit covers the professional
services, including nursing services, furnished in accordance with the
plan of care, patient training and education (not otherwise covered
under the durable medical equipment benefit), remote monitoring, and
monitoring services for the provision of home infusion therapy and home
infusion drugs furnished by a qualified home infusion therapy supplier.
This benefit will ensure consistency in coverage for home infusion
benefits for all Medicare beneficiaries.
    Section 50401 of the BBA of 2018 amended section 1834(u) of the Act
by adding a new paragraph (7) that establishes a home infusion therapy
services temporary transitional payment for eligible home infusion
suppliers for certain items and services furnished in coordination with
the furnishing of transitional home infusion drugs beginning January 1,
2019. This temporary payment covers the cost of the same items and
services, as defined in section 1861(iii)(2)(A) and (B) of the Act,
related to the administration of home infusion drugs. The temporary
transitional payment began on January 1, 2019 and will end the day
before the full implementation of the home infusion therapy benefit on
January 1, 2021, as required by section 5012 of the 21st Century Cures
Act.
    In the CY 2019 HH PPS final rule (83 FR 32340), we finalized the
implementation of temporary transitional payments for home infusion
therapy services to begin on January 1, 2019. In addition, we
implemented the establishment of regulatory authority for the oversight
of national accrediting organizations (AOs) that accredit home infusion
therapy suppliers, and their CMS-approved home infusion therapy
accreditation programs.
2. Overview of Infusion Therapy
    Infusion drugs can be administered in multiple health care
settings, including inpatient hospitals, skilled nursing facilities
(SNFs), hospital outpatient departments (HOPDs), physicians' offices,
and in the home. Traditional fee-for-service (FFS) Medicare provides
coverage for infusion drugs, equipment, supplies, and administration
services. However, Medicare coverage requirements and payment vary for
each of these settings. Infusion drugs, equipment, supplies, and
administration are all covered by Medicare in the inpatient hospital,
SNFs, HOPDs, and physicians' offices.
    Generally, Medicare payment under Part A for the drugs, equipment,
supplies, and services are bundled, meaning a single payment is made on
the basis of expected costs for clinically-defined episodes of care.
For example, if a beneficiary is receiving an infusion drug during an
inpatient hospital stay, the Part A payment for the drug, supplies,
equipment, and drug administration is included in the diagnosis-related
group (DRG) payment to the hospital under the Medicare inpatient
prospective payment system. Beneficiaries are liable for the Medicare
inpatient hospital deductible and no coinsurance for the first 60 days.
Similarly, if a beneficiary is receiving an infusion drug while in a
SNF under a Part A stay, the payment for the drug, supplies, equipment,
and drug administration are included in the SNF prospective payment
system payment. After 20 days of SNF care, there is a daily beneficiary
cost-sharing amount through day 100 when the beneficiary becomes
responsible for all costs for each day after day 100 of the benefit
period.
    Under Medicare Part B, certain items and services are paid
separately while other items and services may be packaged into a single
payment together. For example, in an HOPD and in a physician's office,
the drug is paid separately, generally at the average sales price (ASP)
plus 6 percent (77 FR
[[Page 34687]]
68210).\203\ Medicare also makes a separate payment to the physician or
hospital outpatient departments (HOPD) for administering the drug. The
separate payment for infusion drug administration in an HOPD and in a
physician's office generally includes a base payment amount for the
first hour and a payment add-on that is a different amount for each
additional hour of administration. The beneficiary is responsible for
the 20 percent coinsurance under Medicare Part B.
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    \203\ https://www.govinfo.gov/content/pkg/FR-2012-11-15/pdf/2012-26902.pdf.
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    Medicare FFS covers outpatient infusion drugs under Part B,
``incident to'' a physician's service, provided the drugs are not
usually self-administered by the patient. Drugs that are ``not usually
self-administered,'' are defined in our manual according to how the
Medicare population as a whole uses the drug, not how an individual
patient or physician may choose to use a particular drug. For the
purpose of this exclusion, the term ``usually'' means more than 50
percent of the time for all Medicare beneficiaries who use the drug.
The term ``by the patient'' means Medicare beneficiaries as a
collective whole. Therefore, if a drug is self-administered by more
than 50 percent of Medicare beneficiaries, the drug is generally
excluded from Part B coverage. This determination is made on a drug-by-
drug basis, not on a beneficiary-by-beneficiary basis.\204\ The MACs
update Self-Administered Drug (SAD) exclusion lists on a quarterly
basis.\205\
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    \204\ Medicare Benefit Policy Manual, chapter 15, ``Covered
Medical and Other Health Services'', section 50.2--Determining Self-
Administration of Drug or Biological found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
    \205\ www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?bc=AQAAAAAAAAAAAA%3D%3D.
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    Home infusion therapy involves the intravenous or subcutaneous
administration of drugs or biologicals to an individual at home.
Certain drugs can be infused in the home, but the nature of the home
setting presents different challenges than the settings previously
described. Generally, the components needed to perform home infusion
include the drug (for example, antivirals, immune globulin), equipment
(for example, a pump), and supplies (for example, tubing and
catheters). Likewise, nursing services are usually necessary to train
and educate the patient and caregivers on the safe administration of
infusion drugs in the home. Visiting nurses often play a large role in
home infusion. These nurses typically train the patient or caregiver to
self-administer the drug, educate on side effects and goals of therapy,
and visit periodically to assess the infusion site and provide dressing
changes. Depending on patient acuity or the complexity of the drug
administration, certain infusions may require more training and
education, especially those that require special handling or pre-or
post-infusion protocols. The home infusion process typically requires
coordination among multiple entities, including patients, physicians,
hospital discharge planners, health plans, home infusion pharmacies,
and, if applicable, home health agencies.
    With regard to payment for home infusion therapy under traditional
Medicare, drugs are generally covered under Part B or Part D. Certain
infusion pumps, supplies (including home infusion drugs and the
services required to furnish the drug, (that is, preparation and
dispensing), and nursing are covered in some circumstances through the
Part B durable medical equipment (DME) benefit, the Medicare home
health benefit, or some combination of these benefits. In accordance
with section 50401 of the Bipartisan Budget Act (BBA) of 2018,
beginning on January 1, 2019, for CYs 2019 and 2020, Medicare
implemented temporary transitional payments for home infusion therapy
services furnished in coordination with the furnishing of transitional
home infusion drugs. This payment, for home infusion therapy services,
is only made if a beneficiary is furnished certain drugs and
biologicals administered through an item of covered DME, and payable
only to suppliers enrolled in Medicare as pharmacies that provide
external infusion pumps and external infusion pump supplies (including
the drug). With regard to the coverage of the home infusion drugs,
Medicare Part B covers a limited number of home infusion drugs through
the DME benefit if: (1) The drug is necessary for the effective use of
an external infusion pump classified as DME and determined to be
reasonable and necessary for administration of the drug; and (2) the
drug being used with the pump is itself reasonable and necessary for
the treatment of an illness or injury. Additionally, in order for the
infusion pump to be covered under the DME benefit, it must be
appropriate for use in the home (Sec.  414.202).
    Only certain types of infusion pumps are covered under the DME
benefit. The Medicare National Coverage Determinations Manual, chapter
1, part 4, section 280.14 describes the types of infusion pumps that
are covered under the DME benefit.\206\ For DME external infusion
pumps, Medicare Part B covers the infusion drugs and other supplies and
services necessary for the effective use of the pump. Through the Local
Coverage Determination (LCD) for External Infusion Pumps (L33794), the
DME Medicare administrative contractors (MACs) specify the details of
which infusion drugs are covered with these pumps. Examples of covered
Part B DME infusion drugs include, among others, certain IV drugs for
heart failure and pulmonary arterial hypertension, immune globulin for
primary immune deficiency (PID), insulin, antifungals, antivirals, and
chemotherapy, in limited circumstances.
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    \206\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
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3. Home Infusion Therapy Legislation
a. 21st Century Cures Act
    Effective January 1, 2021, section 5012 of the 21st Century Cures
Act (Pub. L. 114-255) (Cures Act) created a separate Medicare Part B
benefit category under section 1861(s)(2)(GG) of the Act for coverage
of home infusion therapy services needed for the safe and effective
administration of certain drugs and biologicals administered
intravenously, or subcutaneously for an administration period of 15
minutes or more, in the home of an individual, through a pump that is
an item of DME. The infusion pump and supplies (including home infusion
drugs) will continue to be covered under the Part B DME benefit.
Section 1861(iii)(2) of the Act defines home infusion therapy to
include the following items and services: The professional services,
including nursing services, furnished in accordance with the plan,
training and education (not otherwise paid for as DME), remote
monitoring, and other monitoring services for the provision of home
infusion therapy and home infusion drugs furnished by a qualified home
infusion therapy supplier, which are furnished in the individual's
home. Section 1861(iii)(3)(B) of the Act defines the patient's home to
mean a place of residence used as the home of an individual as defined
for purposes of section 1861(n) of the Act. As outlined in section
1861(iii)(1) of the Act, to be eligible to receive home infusion
therapy services under the home infusion therapy benefit, the patient
must be under the care of an applicable provider (defined in section
1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or
physician's assistant), and the patient must be under a physician-
established plan of care that
[[Page 34688]]
prescribes the type, amount, and duration of infusion therapy services
that are to be furnished. The plan of care must be periodically
reviewed by the physician in coordination with the furnishing of home
infusion drugs (as defined in section 1861(iii)(3)(C) of the Act).
Section 1861(iii)(3)(C) of the Act defines a ``home infusion drug''
under the home infusion therapy benefit as a drug or biological
administered intravenously, or subcutaneously for an administration
period of 15 minutes or more, in the patient's home, through a pump
that is an item of DME as defined under section 1861(n) of the Act.
This definition does not include insulin pump systems or any self-
administered drug or biological on a self-administered drug exclusion
list.
    Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home
infusion therapy supplier'' as a pharmacy, physician, or other provider
of services or supplier licensed by the state in which supplies or
services are furnished. The provision specifies qualified home infusion
therapy suppliers must furnish infusion therapy to individuals with
acute or chronic conditions requiring administration of home infusion
drugs; ensure the safe and effective provision and administration of
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; be
accredited by an organization designated by the Secretary; and meet
other such requirements as the Secretary deems appropriate, taking into
account the standards of care for home infusion therapy established by
Medicare Advantage (MA) plans under Part C and in the private sector.
The supplier may subcontract with a pharmacy, physician, other
qualified supplier or provider of medical services, in order to meet
these requirements.
    Section 1834(u)(1) of the Act requires the Secretary to implement a
payment system under which, beginning January 1, 2021, a single payment
is made to a qualified home infusion therapy supplier for the items and
services (professional services, including nursing services; training
and education; remote monitoring, and other monitoring services). The
single payment must take into account, as appropriate, types of
infusion therapy, including variations in utilization of services by
therapy type. In addition, the single payment amount is required to be
adjusted to reflect geographic wage index and other costs that may vary
by region, patient acuity, and complexity of drug administration. The
single payment may be adjusted to reflect outlier situations, and other
factors as deemed appropriate by the Secretary, which are required to
be done in a budget-neutral manner. Section 1834(u)(2) of the Act
specifies certain items that ``the Secretary may consider'' in
developing the HIT payment system: ``the costs of furnishing infusion
therapy in the home, consult[ation] with home infusion therapy
suppliers, . . . payment amounts for similar items and services under
this part and part A, and . . . payment amounts established by Medicare
Advantage plans under part C and in the private insurance market for
home infusion therapy (including average per treatment day payment
amounts by type of home infusion therapy)''. Section 1834(u)(3) of the
Act specifies that annual updates to the single payment are required to
be made, beginning January 1, 2022, by increasing the single payment
amount by the percent increase in the Consumer Price Index for all
urban consumers (CPI-U) for the 12-month period ending with June of the
preceding year, reduced by the 10-year moving average of changes in
annual economy-wide private nonfarm business multifactor productivity
(MFP). Under section 1834(u)(1)(A)(iii), the single payment amount for
each infusion drug administration calendar day, including the required
adjustments and the annual update, cannot exceed the amount determined
under the fee schedule under section 1848 of the Act for infusion
therapy services if furnished in a physician's office. This statutory
provision limits the single payment amount so that it cannot reflect
more than 5 hours of infusion for a particular therapy per calendar
day. Section 1834(u)(4) of the Act also allows the Secretary
discretion, as appropriate, to consider prior authorization
requirements for home infusion therapy services. Finally, section
5012(c)(3) of the 21st Century Cures Act amended section 1861(m) of the
Act to exclude home infusion therapy from the HH PPS beginning on
January 1, 2021.
b. Bipartisan Budget Act of 2018
    Section 50401 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123) amended section 1834(u) of the Act by adding a new paragraph (7)
that established a home infusion therapy services temporary
transitional payment for eligible home infusion suppliers for certain
items and services furnished in coordination with the furnishing of
transitional home infusion drugs, beginning January 1, 2019. This
payment covers the same items and services as defined in section
1861(iii)(2)(A) and (B) of the Act, furnished in coordination with the
furnishing of transitional home infusion drugs. Section
1834(u)(7)(A)(iii) of the Act defines the term ``transitional home
infusion drug'' using the same definition as ``home infusion drug''
under section 1861(iii)(3)(C) of the Act, which is a parenteral drug or
biological administered intravenously, or subcutaneously for an
administration period of 15 minutes or more, in the home of an
individual through a pump that is an item of DME as defined under
section 1861(n) of the Act. The definition of ``home infusion drug''
excludes ``a self-administered drug or biological on a self-
administered drug exclusion list'' but the definition of ``transitional
home infusion drug'' notes that this exclusion shall not apply if a
drug described in such clause is identified in clauses (i), (ii), (iii)
or (iv) of 1834(u)(7)(C) of the Act. Section 1834(u)(7)(C) of the Act
sets out the Healthcare Common Procedure Coding System (HCPCS) codes
for the drugs and biologicals covered under the DME LCD for External
Infusion Pumps (L33794), as the drugs covered during the temporary
transitional period. In addition, section 1834(u)(7)(C) of the Act
states that the Secretary shall assign to an appropriate payment
category drugs which are covered under the DME LCD for External
Infusion Pumps and billed under HCPCS codes J7799 (Not otherwise
classified drugs, other than inhalation drugs, administered through
DME) and J7999 (Compounded drug, not otherwise classified), or billed
under any code that is implemented after the date of the enactment of
this paragraph and included in such local coverage determination or
included in sub-regulatory guidance as a home infusion drug.
    Section 1834(u)(7)(E)(i) of the Act states that payment to an
eligible home infusion supplier or qualified home infusion therapy
supplier for an infusion drug administration calendar day in the
individual's home refers to payment only for the date on which
professional services, as described in section 1861(iii)(2)(A) of the
Act, were furnished to administer such drugs to such individual. This
includes all such drugs administered to such individual on such day.
Section 1842(u)(7)(F) of the Act defines ``eligible home infusion
supplier'' as a supplier who is enrolled in Medicare as a pharmacy that
provides external infusion pumps and external infusion pump supplies,
and that maintains all pharmacy licensure requirements in the State in
which the applicable infusion drugs are administered.
    As set out at section 1834(u)(7)(C) of the Act, identified HCPCS
codes for transitional home infusion drugs are assigned to three
payment categories, as
[[Page 34689]]
identified by their corresponding HCPCS codes, for which a single
amount will be paid for home infusion therapy services furnished on
each infusion drug administration calendar day. Payment category 1
includes certain intravenous infusion drugs for therapy, prophylaxis,
or diagnosis, including antifungals and antivirals; inotropic and
pulmonary hypertension drugs; pain management drugs; and chelation
drugs. Payment category 2 includes subcutaneous infusions for therapy
or prophylaxis, including certain subcutaneous immunotherapy infusions.
Payment category 3 includes intravenous chemotherapy infusions,
including certain chemotherapy drugs and biologicals. The payment
category for subsequent transitional home infusion drug additions to
the LCD and compounded infusion drugs not otherwise classified, as
identified by HCPCS codes J7799 and J7999, will be determined by the
DME MACs.
    In accordance with section 1834(u)(7)(D) of the Act, each payment
category is paid at amounts in accordance with the Physician Fee
Schedule (PFS) for each infusion drug administration calendar day in
the individual's home for drugs assigned to such category, without
geographic adjustment. Section 1834(u)(7)(E)(ii) of the Act requires
that in the case that two (or more) home infusion drugs or biologicals
from two different payment categories are administered to an individual
concurrently on a single infusion drug administration calendar day, one
payment for the highest payment category will be made.
4. Summary of CY 2019 Home Infusion Therapy Provisions
    In the CY 2019 Home Health Prospective Payment System (HH PPS)
final rule (83 FR 56579) we finalized the implementation of the home
infusion therapy services temporary transitional payments under
paragraph (7) of section 1834(u) of the Act. These services are
furnished in the individual's home to an individual who is under the
care of an applicable provider (defined in section 1861(iii)(3)(A) of
the Act as a physician, nurse practitioner, or physician's assistant)
and where there is a plan of care established and periodically reviewed
by a physician prescribing the type, amount, and duration of infusion
therapy services. Only eligible home infusion suppliers can bill for
the temporary transitional payments. Therefore, in accordance with
section 1834(u)(7)(F) of the Act, we clarified that this means that
existing DME suppliers that are enrolled in Medicare as pharmacies that
provide external infusion pumps and external infusion pump supplies,
who comply with Medicare's DME Supplier and Quality Standards, and
maintain all pharmacy licensure requirements in the State in which the
applicable infusion drugs are administered, are considered eligible
home infusion suppliers.
    Section 1834(u)(7)(C) of the Act assigns transitional home infusion
drugs, identified by the HCPCS codes for the drugs and biologicals
covered under the DME LCD for External Infusion Pumps (L33794),\207\
into three payment categories, for which we established a single
payment amount in accordance with section 1834(u)(7)(D) of the Act.
This section states that each single payment amount per category will
be paid at amounts equal to the amounts determined under the PFS
established under section 1848 of the Act for services furnished during
the year for codes and units of such codes, without geographic
adjustment. Therefore, we created a new HCPCS G-code for each of the
three payment categories and finalized the billing procedure for the
temporary transitional payment for eligible home infusion suppliers. We
stated that the eligible home infusion supplier would submit, in line-
item detail on the claim, a G-code for each infusion drug
administration calendar day. The claim should include the length of
time, in 15-minute increments, for which professional services were
furnished. The G-codes can be billed separately from, or on the same
claim as, the DME, supplies, or infusion drug, and are processed
through the DME MACs. On August 10, 2018, we issued Change Request:
R4112CP: Temporary Transitional Payment for Home Infusion Therapy
Services for CYs 2019 and 2020 \208\ outlining the requirements for the
claims processing changes needed to implement this payment.
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    \207\ https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794&ver=83&Date=05%2f15%2f2019&DocID=L33794&bc=iAAAABAAAAAA&.
    \208\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
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    And finally, we finalized the definition of ``infusion drug
administration calendar day'' in regulation as the day on which home
infusion therapy services are furnished by skilled professional(s) in
the individual's home on the day of infusion drug administration. The
skilled services provided on such day must be so inherently complex
that they can only be safely and effectively performed by, or under the
supervision of, professional or technical personnel (42 CFR 486.505).
Section 1834(u)(7)(E)(i) of the Act clarifies that this definition is
with respect to the furnishing of ``transitional home infusion drugs''
and ``home infusion drugs'' to an individual by an ``eligible home
infusion supplier'' and a ``qualified home infusion therapy supplier.''
The definition of ``infusion drug administration calendar day'' applies
to both the temporary transitional payment in CYs 2019 and 2020 and the
permanent home infusion therapy benefit to be implemented beginning in
CY 2021. Although we finalized this definition in regulation in the CY
2019 HH PPS final rule with comment (83 FR 56583), we stated that we
would carefully monitor the effects of this definition on access to
care and we stated that, if warranted and if within the limits of our
statutory authority, we would engage in additional rulemaking our
guidance regarding this definition. In that same rule, we also
solicited additional comments on this interpretation and on its effects
on access to care. We have been monitoring utilization of home infusion
therapy services beginning on January 1, 2019; however, we do not have
sufficient data on utilization yet to determine the effects on access
to care. We will be addressing those comments received in response to
the CY 2019 HH PPS final rule with comment as well as those received
for this proposed rule in the CY 2020 HH PPS final rule.
B. CY 2020 Temporary Transitional Payment Rates for Home Infusion
Therapy Services
    As previously noted, section 50401 of the BBA of 2018 amended
section 1834(u) of the Act by adding a new paragraph (7) that
established a home infusion therapy services temporary transitional
payment for eligible home infusion suppliers for certain items and
services furnished to administer home infusion drugs beginning January
1, 2019. This temporary payment covers the cost of the same items and
services including professional services, training and education,
monitoring, and remote monitoring services, as defined in section
1861(iii)(2)(A) and (B) of the Act, related to the administration of
home infusion drugs. The temporary transitional payment began on
January 1, 2019 and will end the day before the full implementation of
the home infusion therapy benefit on January 1, 2021, as required by
section 5012 of the 21st Century Cures Act. The list of transitional
home infusion drugs and the payment categories for the temporary
transitional payment for home infusion therapy services can be
[[Page 34690]]
found in Tables 55 and 56 in the CY 2019 HH PPS proposed rule (83 FR
32465 and 32466).\209\
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    \209\ https://www.govinfo.gov/content/pkg/FR-2018-07-12/pdf/2018-14443.pdf
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    Section 1834(u)(7)(D)(i) of the Act sets the payment amounts for
each category equal to the amounts determined under the PFS established
under section 1848 of the Act for services furnished during the year
for codes and units for such codes specified without application of
geographic wage adjustment under section 1848(e) of the Act. That is,
the payment amounts are based on the PFS rates for the Current
Procedural Terminology (CPT) codes corresponding to each payment
category. For eligible home infusion suppliers to bill the temporary
transitional payments for home infusion therapy services for an
infusion drug administration calendar day, we created a G-code
associated with each of the three payment categories. The J-codes for
eligible home infusion drugs, the G-codes associated with each of the
three payment categories, and instructions for billing for the
temporary transitional home infusion therapy payment are found in
Change Request 10836, ``Temporary Transitional Payment for Home
Infusion Therapy Services for CYs 2019 and 2020.'' \210\
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    \210\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
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    Therefore, in this proposed rule, we are updating the temporary
transitional payments based on the CPT code payment amounts in the CY
2020 PFS. At the time of publication of this proposed rule, we do not
yet have the CY 2020 PFS rates. However, actual payments starting on
January 1, 2020 will be based on the PFS amounts as specified in
section 1834(u)(7)(D) of the Act as discussed earlier. We will publish
these updated rates in the CY 2020 physician fee schedule final
rule.\211\
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    \211\ https://www.cms.gov/apps/physician-fee-schedule/.
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C. Proposed Home Infusion Therapy Services for CY 2021 and Subsequent
Years
    As previously described in this proposed rule, upon completion of
the temporary transitional payments for home infusion therapy services
at the end of CY 2020, payment for home infusion therapy services under
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255) would be
implemented beginning January 1, 2021. However, we are making proposals
regarding home infusion therapy services for CY 2021 and beyond in the
CY 2020 HH PPS proposed rule to allow adequate time for eligible home
infusion therapy suppliers to make any necessary software and business
process changes for implementation on January 1, 2021.
1. Scope of Benefit and Conditions for Payment
    Section 1861(iii) of the Act establishes certain provisions related
to home infusion therapy with respect to the requirements that must be
met for Medicare payment to be made to qualified home infusion therapy
suppliers. These provisions serve as the basis for determining the
scope of the home infusion drugs eligible for coverage of home infusion
therapy services, outlining beneficiary qualifications and plan of care
requirements, and establishing who can bill for payment under the
benefit.
a. Home Infusion Drugs
    In the 2019 Home Health Prospective Payment System (HH PPS)
proposed rule (83 FR 32466) we discussed the relationship between the
home infusion therapy benefit and the DME benefit. We stated that, as
there is no separate Medicare Part B DME payment for the professional
services associated with the administration of certain home infusion
drugs covered as supplies necessary for the effective use of external
infusion pumps, we consider the home infusion therapy benefit to be a
separate payment in addition to the existing payment for the DME
equipment, accessories, and supplies (including the home infusion drug)
made under the DME benefit. Consistent with the definition of ``home
infusion therapy,'' the home infusion therapy payment explicitly and
separately pays for the professional services related to the
administration of the drugs identified on the DME LCD for external
infusion pumps, which are furnished in the individual's home. For
purposes of the temporary transitional payments for home infusion
therapy services in CYs 2019 and 2020, the term ``transitional home
infusion drug'' includes the HCPCS codes for the drugs and biologicals
covered under the DME LCD for External Infusion Pumps (L33794).
However, while section 1834(u)(7)(A)(iii) of the Act defines the term
``transitional home infusion drug,'' section 1834(u)(7)(A)(iii) of the
Act does not specify the HCPCS codes for home infusion drugs for which
home infusion therapy services would be covered beginning in CY 2021.
We received comments on the CY 2019 HH PPS proposed rule requesting
clarification of the drugs and biologicals identified as ``home
infusion drugs'' and whether, under the permanent benefit to be
implemented in 2021, the scope of drugs would expand beyond the drugs
identified for coverage under the temporary transitional payment.
Consequently, we stated in the CY 2019 HH PPS final rule (83 FR 56584)
that we would continue to examine the criteria for ``home infusion
drugs'' for coverage of home infusion therapy services beginning in
2021.
    Section 1861(iii)(3)(C) of the Act defines ``home infusion drug''
as a parenteral drug or biological administered intravenously, or
subcutaneously for an administration period of 15 minutes or more, in
the home of an individual through a pump that is an item of durable
medical equipment (as defined in section 1861(n) of the Act). Such term
does not include insulin pump systems or self-administered drugs or
biologicals on a self-administered drug exclusion list. This definition
not only specifies that the drug or biological must be administered
through a pump that is an item of DME, but references the statutory
definition of DME at 1861(n) of the Act. This means that ``home
infusion drugs'' are drugs and biologicals administered through a pump
that is covered under the Medicare Part B DME benefit. Therefore, we
interpret this statutory reference in section 1861(iii)(3)(C) of the
Act to mean that Medicare payment for home infusion therapy is for
services furnished in coordination with the furnishing of the infusion
drugs and biologicals specified on the DME LCD for External Infusion
Pumps.\212\
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    \212\ https://med.noridianmedicare.com/ documents/2230703/
7218263/External+Infusion+Pumps+LCD.
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    In order to be covered under the Part B DME benefit, the external
infusion pump must be classified as an item of DME, the related drug
must be reasonable and necessary for the treatment of illness or injury
or to improve the functioning of a malformed body member, an infusion
pump is necessary to safely administer the drug, and it has to meet all
other applicable Medicare statutory and regulatory requirements.\213\
The DME LCD for External Infusion Pumps (L33794) specifies the
``reasonable and necessary'' coverage criteria in order to support
coverage of external infusion pumps for the indications identified on
the National Coverage Determination (NCD) for Infusion Pumps.\214\ The
DME
[[Page 34691]]
Medicare Administrative Contractors (MACs) make the determinations for
which drugs meet this coverage criteria, and in general, update the
LCDs quarterly or as needed. There are four MACs, covering various
jurisdictions, that work together to issue the same LCD under their
contracts. Therefore, we believe that the term ``home infusion drugs''
for coverage of home infusion therapy services, refers to the drugs and
biologicals identified on the DME LCD for External Infusion Pumps
(L33794). Therefore, we are proposing to carry forward the definition
of ``home infusion drugs'' as defined for the temporary, transitional
payment for home infusion therapy services (83 FR 56579). That is, for
home infusion therapy services furnished on and after January 1, 2021,
we are proposing that ``home infusion drugs'' are parenteral drugs and
biologicals administered intravenously, or subcutaneously for an
administration period of 15 minutes or more, in the home of an
individual through a pump that is an item of DME covered under the
Medicare Part B DME benefit.
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    \213\ Local Coverage Determination (LCD): External Infusion
Pumps (L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD.
    \214\ https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId= 223&ncdver=
2&DocID=280.14&SearchType=Advanced&bc= IAAAABAAAAAA&.
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    For external infusion pumps, the supplier must instruct
beneficiaries on the use of Medicare covered items, and maintain proof
of delivery and beneficiary instruction in accordance with 42 CFR
424.57(c)(12). The teaching and training for the safe and effective use
of the external infusion pump is covered and paid for under the DME
benefit. By contrast, the services covered under the home infusion
therapy benefit are intended to provide teaching and training on the
provision of home infusion drugs besides the teaching and training
covered under the DME benefit, as we described in the CY2019 HH PPS
proposed rule (83 FR 32467). The teaching and training provided under
the home infusion therapy benefit is not intended to duplicate teaching
and training that is already covered under the DME benefit. We are
soliciting comments on carrying forward the definition of ``home
infusion drugs'' as described previously to the permanent home infusion
therapy services benefit beginning on January 1, 2021.
b. Patient Eligibility and Plan of Care Requirements
    Subparagraphs (A) and (B) of section 1861(iii)(1) of the Act set
forth beneficiary eligibility and plan of care requirements for ``home
infusion therapy.'' In accordance with section 1861(iii)(1)(A) of the
Act, the beneficiary must be under the care of an applicable provider,
defined in section 1861(iii)(3)(A) of the Act as a physician, nurse
practitioner, or physician assistant. In accordance with section
1861(iii)(1)(B) of the Act, the beneficiary must also be under a plan
of care, established by a physician (defined at section 1861(r)(1) of
the Act), prescribing the type, amount, and duration of infusion
therapy services that are to be furnished, and periodically reviewed,
in coordination with the furnishing of home infusion drugs under Part B
based on these statutory requirements. Section 486.520 sets out the
standards of care that qualified home infusion therapy suppliers must
meet in order to participate in Medicare. Section 486.520(a) requires
that all patients be under the care of an applicable provider, as
defined at Sec.  486.505. Section 486.520(b) requires that the
qualified home infusion therapy supplier must ensure that all patients
have a plan of care established by a physician that prescribes the
type, amount, and duration of home infusion therapy services that are
to be furnished. The plan of care must include the specific medication,
the prescribed dosage and frequency, as well as the professional
services to be utilized for treatment. In addition, the plan of care
would specify the individualized care and services necessary to meet
the patient-specific needs. Section 486.520(c) requires that the
qualified home infusion therapy supplier must ensure that the patient
plan of care is periodically reviewed by a physician.
    We are proposing to make a number of revisions to the regulations
to implement the home infusion therapy services payment system
beginning with January 1, 2021, as outlined in section VI.D of this
proposed rule. We propose to add a new 42 CFR part 414, subpart P, to
implement the home infusion therapy services conditions for payment. In
accordance with the standards at Sec.  486.520, we are proposing
conforming regulations text, at Sec.  414.1505, requiring that home
infusion therapy services be furnished to an eligible beneficiary by,
or under arrangement with, a qualified home infusion therapy supplier
that meets the health and safety standards for qualified home infusion
therapy suppliers at Sec.  486.520(a) through (c). We also propose at
Sec.  414.1510 that, as a condition for payment, qualified home
infusion therapy suppliers ensure that a beneficiary meets certain
eligibility criteria for coverage of services, as well as ensure that
certain plan of care requirements are met. We propose at Sec.  414.1510
to require that a beneficiary must be under the care of an applicable
provider, defined in section 1861(iii)(3)(A) of the Act as a physician,
nurse practitioner, or physician assistant. Additionally, we propose at
Sec.  414.1510, to require that a beneficiary must be under a plan of
care, established by a physician. In accordance with section
1861(iii)(1)(B) of the Act, a physician is defined at section
1861(r)(1) of the Act, as a doctor of medicine or osteopathy legally
authorized to practice medicine and surgery by the State in which he
performs such function or action. We propose to require at Sec.
414.1515, that the plan of care must contain those items listed in
Sec.  486.520(b). In addition to the type of home infusion therapy
services to be furnished, the physician's orders for services in the
plan of care must also specify at what frequency the services will be
furnished, as well as the healthcare professional that will furnish
each of the ordered services. We are soliciting comments on the
proposed conditions for payment, which include patient eligibility and
plan of care requirements.
c. Qualified Home Infusion Therapy Suppliers and Professional Services
    Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home
infusion therapy supplier'' as a pharmacy, physician, or other provider
of services or supplier licensed by the State in which the pharmacy,
physician, or provider of services or supplier furnishes items or
services. The qualified home infusion therapy supplier must: Furnish
infusion therapy to individuals with acute or chronic conditions
requiring administration of home infusion drugs; ensure the safe and
effective provision and administration of home infusion therapy on a 7-
day-a-week, 24-hour a-day basis; be accredited by an organization
designated by the Secretary; and meet such other requirements as the
Secretary determines appropriate. In accordance with this section of
the Act, 42 CFR part 486, subpart I, establishes the requirements that
a qualified home infusion therapy supplier must meet in order to
participate in the Medicare program. These requirements provide a
framework for CMS to approve home infusion therapy accreditation
organizations in order for them to approve Medicare certification of
qualified home infusion therapy suppliers. Section 488.1010 sets forth
the requirements that accrediting organizations must meet in order to
[[Page 34692]]
demonstrate that their substantive accreditation requirements are
sufficient for certification of a Medicare qualified home infusion
therapy supplier. And finally, Sec.  486.525 sets out the services
furnished by a qualified home infusion therapy supplier which are:
Professional services, including nursing services; training and
education; and remote monitoring and monitoring services. Importantly,
neither the statute, nor the health and safety standards and
accreditation requirements require the qualified home infusion therapy
supplier to furnish the pump, home infusion drug, or related pharmacy
services. The infusion pump, drug, and other supplies, including the
services required to furnish these items (that is, the compounding and
dispensing of the drug) remain covered under the DME benefit.
    In accordance with section 1861(iii)(1) of the Act, the CY 2019 HH
PPS proposed rule described the professional and nursing services, as
well as the training, education, and monitoring services included in
the payment to a qualified home infusion therapy supplier for the
provision of home infusion drugs (83 FR 32467). We did not specifically
enumerate a list of ``professional services'' in order to avoid
limiting services or the involvement of providers of services or
suppliers that may be necessary in the care of an individual patient.
However, it is important to note that, under section 1862(a)(1)(A) of
the Act, no payment can be made for Medicare services under Part B that
are not reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body
member, unless explicitly authorized by statutes (such as vaccines).
    Payment to a qualified home infusion therapy supplier is for an
infusion drug administration calendar day in the individual's home,
which, in accordance with section 1834(u)(7)(E) of the Act, refers to
payment only for the date on which professional services were furnished
to administer such drugs to such individual. Ultimately, the qualified
home infusion therapy supplier is the entity responsible for furnishing
the necessary services to administer the drug in the home and, as we
noted in the CY 2019 HH PPS final rule (83 FR 56581),
``administration'' refers to the process by which the drug is entering
the patient's body. Therefore, it is necessary for the qualified home
infusion therapy supplier to be in the patient's home, on occasions
when the drug is being administered in order to provide an accurate
assessment to the physician responsible for ordering the home infusion
drug and services. The services provided would include patient
evaluation and assessment; training and education of patients and their
caretakers, assessment of vascular access sites and obtaining any
necessary bloodwork; and evaluation of medication administration.
However, visits made solely for the purposes of venipuncture on days
where there is no administration of the infusion drug would not be
separately paid because the single payment includes all services for
administration of the drug. Payment for an infusion drug administration
calendar day is a bundled payment, which reflects not only the visit
itself, but any necessary follow-up work (which could include visits
for venipuncture), or care coordination provided by the qualified home
infusion therapy supplier. Any care coordination, or visits made for
venipuncture, provided by the qualified home infusion therapy supplier
that occurs outside of an infusion drug administration calendar day
would be included in the payment for the visit (83 FR 56581).
    Additionally, section 1861(iii)(1)(B) of the Act requires that the
patient be under a plan of care established and periodically reviewed
by a physician, in coordination with the furnishing of home infusion
drugs. The physician is responsible for ordering the reasonable and
necessary services for the safe and effective administration of the
home infusion drug, as indicated in the patient plan of care. In
accordance with this section, the physician is responsible for
coordinating the patient's care in consultation with the DME supplier
furnishing the home infusion drug. We recognize that collaboration
between the ordering physician and the DME supplier furnishing the home
infusion drug is imperative in providing safe and effective home
infusion. Payment for physician services, including any home infusion
care coordination services, are separately paid to the physician under
the PFS and are not covered under the home infusion therapy benefit.
However, payment under the home infusion therapy benefit to eligible
home infusion therapy suppliers is for the professional services that
inform collaboration between physicians and home infusion therapy
suppliers. Care coordination between the physician and DME supplier,
although likely to include review of the services indicated in the home
infusion therapy supplier plan of care, is paid separately from the
payment under the home infusion therapy benefit.
    The DME Quality Standards require the supplier to review the
patient's record and consult with the prescribing physician as needed
to confirm the order and to recommend any necessary changes,
refinements, or additional evaluations to the prescribed equipment,
item(s), and/or service(s). Follow-up services to the beneficiary and/
or caregiver(s), must be consistent with the type(s) of equipment,
item(s) and service(s) provided, and include recommendations from the
prescribing physician or healthcare team member(s).\215\ Additionally,
DME suppliers are required to communicate directly with patients
regarding their medications. As described in Chapter 5 of the Medicare
Program Integrity Manual: Items and Services Having Special DME Review
Considerations, section 5.2.8, DME suppliers are required to contact
the beneficiary prior to dispensing a refill to the original order.
This is done to ensure that the refilled item remains reasonable and
necessary, existing supplies are approaching exhaustion, and to confirm
any changes/modifications to the order.\216\
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    \215\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Downloads/Final-DMEPOS-Quality-Standards-Eff-01-09-2018.pdf.
    \216\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c05.pdf.
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    Additionally, the ordering physician can bill separately for
physicians' services such as Chronic Care Management (CCM) and Remote
Patient Monitoring codes under the PFS for care planning and
coordination of home infusion therapy services. CCM services are
typically provided outside of face-to-face patient visits, and focus on
characteristics of advanced primary care such as a continuous
relationship with a designated member of the care team; patient support
for chronic diseases to achieve health goals; 24/7 patient access to
care and health information; receipt of preventive care; patient and
caregiver engagement; and timely sharing and use of health
information.\217\ Remote patient monitoring services, including
telephone evaluation and management services by a physician, or brief
virtual check-ins, can also be billed under the PFS. In general, when
communication technology-based services originate from a related
evaluation and management (E/M) visit provided within the previous 7
days by the same physician or other qualified health care professional,
this service is considered bundled into that previous E/M visit and
would not be separately billable.
[[Page 34693]]
However, physicians can bill separately for remote monitoring services
after an initial face-to-face visit. Billing for this service requires
at least 30 minutes of physician time and includes the collection and
interpretation of data. Beginning January 1, 2019, Medicare now also
pays separately for set-up, interpretation, and transmission of data
collected remotely. Additionally, virtual check-in services are
billable when a physician or other qualified health care professional
has a brief non-face-to-face check-in with a patient via communication
technology to assess whether the patient's condition necessitates an
office visit, and can be billed in cases where the check-in service
does not lead to an office visit, as there is no office visit with
which the check-in service can be bundled.\218\
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    \217\ https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/chroniccaremanagement.pdf.
    \218\ https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    In summary, the qualified home infusion therapy supplier is
responsible for the reasonable and necessary services related to the
administration of the home infusion drug in the individual's home.
These services may require some degree of care coordination or
monitoring outside of an infusion drug administration calendar day;
however, these services are built into the bundled payment. Care
coordination furnished by the DME supplier, who is responsible for
furnishing the equipment and supplies, including the home infusion
drug, is required and paid for under the DME benefit. Care coordination
furnished by the physician who establishes the plan of care is
separately billable under the PFS.
d. Home Infusion Therapy and the Interaction With Home Health
    Because a qualified home infusion therapy supplier is not required
to become accredited as a Part B DME supplier or to furnish the home
infusion drug, and because payment is determined by the provision of
services furnished in the patient's home, we acknowledged in the CY
2019 HH PPS proposed rule the potential for overlap between the new
home infusion therapy benefit and the home health benefit (83 FR
32469). We stated that a beneficiary is not required to be considered
homebound in order to be eligible for the home infusion therapy
benefit; however, there may be instances where a beneficiary under a
home health plan of care also requires home infusion therapy services.
Additionally, because section 5012 of the 21st Century Cures Act amends
section 1861(m) of the Act to exclude home infusion therapy from home
health services effective on January 1, 2021, we stated that a
beneficiary may utilize both benefits concurrently. We solicited
feedback on the relationship between the Medicare home health benefit
and the home infusion therapy benefit, particularly in instances when a
beneficiary meets eligibility requirements for both.
    In general, commenters stated concern with the ability of qualified
home infusion therapy suppliers to furnish the professional services
required under both benefits when care needs overlap. One commenter
stated that the benefits effectively do not overlap, as ``each benefit
stands independent from the other and covers different treatment and
different care.'' Specifically, this commenter stated that home health
agencies do not own or operate pharmacies, prepare home infusion drugs,
or provide the care coordination necessary to manage drug infusion.
Similarly, the commenter stated that home infusion providers are
neither certified nor authorized to offer the full array of care
services required of a home health agency.
    We agree that there are unique services and providers involved in
the delivery of care under both the home health benefit and the home
infusion therapy benefit. We also recognize that home health agencies
and DME suppliers have separate requirements for accreditation and
conditions for payment. Likewise, the requirements for home infusion
therapy accreditation, set out at 42 CFR part 486, subpart I, are
unique to qualified home infusion therapy suppliers. For instance, in
order to furnish the services related to the administration of home
infusion drugs, a qualified home infusion therapy supplier is not
required to meet the Medicare Home Health Conditions of Participation
(CoPs) at 42 CFR part 484, unless such supplier is also a Medicare-
certified home health agency. Additionally, a qualified home infusion
therapy supplier is not required to meet the requirements under the DME
Quality and Supplier Standards, unless such supplier is also a
Medicare-enrolled DME supplier. Therefore, we would not expect a home
health agency that becomes accredited as a qualified home infusion
therapy supplier to furnish (or arrange for the furnishing of) the DME,
supplies (including the home infusion drug), and related services when
a patient is not under a home health plan of care, nor would it be
permissible for a DME supplier that becomes accredited as a qualified
home infusion therapy supplier to furnish home health services under
the Medicare home health benefit. The home health benefit requires that
home health agencies arrange for the necessary DME and coordinate home
infusion services when a patient is under a home health plan of care.
In accordance with the Home Health CoPs at 42 CFR 484.60, the home
health agency must assure communication with all physicians involved in
the plan of care, as well as integrate all orders and services provided
by all physicians and other healthcare disciplines, such as nursing,
rehabilitative, and social services.
    Furthermore, because both the home health agency and the qualified
home infusion therapy supplier furnish services in the individual's
home, and may potentially be the same entity, it is necessary to
outline the payment process in instances when a beneficiary is
utilizing both benefits. We continue to believe that the best process
for payment for furnishing home infusion therapy services to
beneficiaries who qualify for both benefits is as outlined in the CY
2019 HH PPS proposed rule (83 FR 32469). If a patient receiving home
infusion therapy is also under a home health plan of care, and receives
a visit that is unrelated to home infusion therapy, then payment for
the home health visit would be covered by the HH PPS and billed on the
home health claim. When the home health agency furnishing home health
services is also the qualified home infusion therapy supplier
furnishing home infusion services, and a home visit is exclusively for
the purpose of furnishing items and services related to the
administration of the home infusion drug, the home health agency would
submit a home infusion therapy services claim under the home infusion
therapy benefit. If the home visit includes the provision of other home
health services in addition to, and separate from, home infusion
therapy services, the home health agency would submit both a home
health claim under the HH PPS and a home infusion therapy claim under
the home infusion therapy benefit. However, the agency must separate
the time spent furnishing services covered under the HH PPS from the
time spent furnishing services covered under the home infusion therapy
benefit. DME continues to be excluded from the consolidated billing
requirements governing the HH PPS and therefore, the DME services,
equipment, and supplies (including the drug and related services) will
continue to be paid for outside of the HH PPS. If the qualified home
infusion therapy supplier is not the same entity as the home health
agency furnishing the home health services, the
[[Page 34694]]
home health agency would continue to bill under the HH PPS on the home
health claim, and the qualified home infusion therapy supplier would
bill for the services related to the administration of the home
infusion drugs on the home infusion therapy services claim.
    After publishing the CY 2019 HH PPS final rule with comment period,
we received correspondence requesting clarification of the relationship
between the home health benefit and the furnishing of home infusion
therapy services in CYs 2019 and 2020. Specifically, we received
questions as to whether an eligible home infusion supplier can furnish
home infusion therapy services, and bill for the temporary transitional
payment, to the same patient that is under a home health plan of care,
where the home health agency is furnishing care unrelated to the home
infusion therapy, such as wound care and physical therapy. In response,
we posted a ``Frequently Asked Questions'' (FAQs) document to our home
infusion therapy web page,\219\ relying on the authority of section
1834(u)(7)(G) of the Act (as added by section 50401 of the BBA of
2018), which allows the Secretary to implement the transitional home
infusion therapy benefit by program instruction or otherwise,
notwithstanding any other provision of law. In this FAQ, we clarified
that during the 2-year temporary transitional payment period (CYs 2019
and 2020), home health services covered under the Medicare home health
benefit continue to include the in-home services covered under the new
home infusion therapy benefit. Therefore, if a patient's home health
plan of care includes home infusion therapy services, the costs of such
services would be recognized as part of the payment made for the
patient's specific Home Health Resource Group (HHRG). The clarification
in the FAQs was not intended to, and does not, make any changes to our
general policy that, as with any other plan of care service that the
HHA cannot provide, if a patient under a home health plan of care
requires in-home skilled services needed for the safe and effective
administration of a transitional home infusion drug and the home health
agency determines it does not have the staff available to furnish those
services as home health services under the home health benefit (and
cannot provide such services under arrangement), the home health agency
should not accept the patient on service or continue to provide other
home health services under an existing plan of care. In accordance with
the Home Health CoPs at Sec.  484.60 home health agencies can only
accept patients for treatment on the reasonable expectation that the
home health agency can meet the patient's medical, nursing,
rehabilitative, and social needs in his or her place of residence.
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    \219\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
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    We believe the statutory provisions at section 1861(m) of the Act
do not allow both home health providers and eligible home infusion
suppliers to furnish and bill for home infusion therapy services to
beneficiaries under a home health plan of care. Therefore we stated in
the CY 2019 HH PPS final rule that home infusion therapy was excluded
from home health services beginning in CY 2019. This was intended to
convey that payment for the separate, transitional home infusion
therapy services benefit under section 1834(u)(7) of the Act is
excluded from home health services. Sections 5012(c)(3) and (d) of the
Cures Act, read together, clearly indicate that home infusion therapy
is not excluded from home health services until January 1, 2021. A home
health agency may subcontract with an eligible home infusion supplier
in CYs 2019 and 2020 to furnish home infusion therapy services to a
beneficiary under a home health plan of care; however, such services
would be considered home health services and should be billed by the
home health agency under the Medicare home health benefit and not the
home infusion therapy benefit. In addition, the eligible home infusion
supplier cannot bill for such services under the home infusion therapy
benefit as such services are covered as home health services under the
Medicare home health benefit.
    Therefore, for home infusion therapy services furnished in CYs 2019
and 2020, if a patient who is considered homebound and is under a
Medicare home health plan of care, the home health agency should
continue to furnish the professional services related to the
administration of transitional home infusion drugs, in accordance with
the Home Health CoPs and other regulations, as home health services.
Additionally, the home health agency shall bill for such services as
home health services under the Medicare home health benefit. Further,
if an eligible home infusion supplier is under contract with a home
health agency to provide the necessary home infusion therapy services
to a patient under a home health plan of care, such services would be
considered home health services and billed by the home health agency
under the Medicare home health benefit and not the home infusion
therapy benefit. Additionally, the eligible home infusion supplier
under contract with the home health agency cannot bill Medicare for the
temporary transitional payment but would seek payment from the home
health agency. This clarification regarding the relationship between
the home health benefit and the home infusion benefit in CYs 2019 and
2020 is not intended to limit access to home infusion therapy services
to those beneficiaries receiving home health services under the
Medicare home health benefit. Neither the transitional nor the
permanent home infusion therapy services benefit require that the
beneficiary be under a home health plan of care. Rather, because
transitional home infusion therapy services are separately payable
beginning January 1, 2019, the receipt of home health services is not
necessary in order for a beneficiary to be eligible to receive home
infusion therapy services.
2. Solicitation of Public Comments Regarding Notification of Infusion
Therapy Options Available Prior To Furnishing Home Infusion Therapy
Services
    Section 1834(u)(6) of the Act requires that prior to the furnishing
of home infusion therapy to an individual, the physician who
establishes the plan described in section 1861(iii)(1) of the Act for
the individual shall provide notification (in a form, manner, and
frequency determined appropriate by the Secretary) of the options
available (such as home, physician's office, hospital outpatient
department) for the furnishing of infusion therapy under this part. We
recognize there are several possible forms, manners, and frequencies
that physicians may use to notify patients of their infusion therapy
options. For example, a physician may verbally discuss the treatment
options with the patient during the visit and annotate the treatment
decision in the medical records before establishing the infusion
therapy plan. Some physicians may also provide options in writing to
the patient in the hospital discharge papers or office visit summaries,
as well as retain a written patient attestation that all options were
provided and considered. Additionally, the frequency of discussing
these options could vary based on a routine scheduled visit or
according the individual's clinical needs.
    We are soliciting comments in the CY 2020 PFS proposed rule
regarding the appropriate form, manner, and frequency that any
physician must use to provide notification of the treatment
[[Page 34695]]
options available to his/her patient for the furnishing of infusion
therapy (home or otherwise) under Medicare Part B. We also invite
comments in this rule on any additional interpretations of this
notification requirement and whether this requirement is already being
met under the temporary transitional payment.
D. Proposed Payment Categories and Amounts for Home Infusion Therapy
Services for CY 2021
    Section 1834(u)(1) of the Act provides the authority for the
development of a payment system for Medicare-covered home infusion
therapy services. In accordance with section 1834(u)(1)(A)(i) of the
Act, the Secretary is required to implement a payment system under
which a single payment is made to a qualified home infusion therapy
supplier for items and services furnished by a qualified home infusion
therapy supplier in coordination with the furnishing of home infusion
drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit of
single payment under this payment system is for each infusion drug
administration calendar day in the individual's home, and requires the
Secretary, as appropriate, to establish single payment amounts for
different types of infusion therapy, taking into account variation in
utilization of nursing services by therapy type. Section
1834(u)(1)(A)(iii) of the Act provides a limitation to the single
payment amount, requiring that it shall not exceed the amount
determined under the PFS (under section 1848 of the Act) for infusion
therapy services furnished in a calendar day if furnished in a
physician office setting. Furthermore, such single payment shall not
reflect more than 5 hours of infusion for a particular therapy in a
calendar day. This permanent payment system would become effective for
home infusion therapy items and services furnished on or after January
1, 2021.
    In accordance with section 1834(u)(1)(A)(ii) of the Act, a unit of
single payment for each infusion drug administration calendar day in
the individual's home must be established for types of infusion
therapy, taking into account variation in utilization of nursing
services by therapy type. Furthermore, section 1834(u)(1)(B)(ii) of the
Act requires that the payment amount reflect factors such as patient
acuity and complexity of drug administration. We believe that the best
way to establish a single payment amount that varies by utilization of
nursing services and reflects patient acuity and complexity of drug
administration, is to group home infusion drugs by J-code into payment
categories reflecting similar therapy types. Therefore, each payment
category would reflect variations in infusion drug administration
services.
    Section 1834(u)(7)(C) of the Act established three payment
categories, with the associated J-code for each transitional home
infusion drug (see Table 28), for the home infusion therapy services
temporary transitional payment. Payment category 1 comprises certain
intravenous infusion drugs for therapy, prophylaxis, or diagnosis,
including, but not limited to, antifungals and antivirals; inotropic
and pulmonary hypertension drugs; pain management drugs; and chelation
drugs. Payment category 2 comprises subcutaneous infusions for therapy
or prophylaxis, including, but not limited to, certain subcutaneous
immunotherapy infusions. Payment category 3 comprises intravenous
chemotherapy infusions, including certain chemotherapy drugs and
biologicals.
    Maintaining the three current payment categories, with the
associated J-codes as outlined in section 1834(u)(7)(C) of the Act,
utilizes an already established framework for assigning a unit of
single payment (per category), accounting for different therapy types,
as required by section 1834(u)(1)(A)(ii) of the Act. The payment amount
for each of these three categories is different, though each category
has its associated single payment amount. The single payment amount
(per category) would thereby reflect variations in nursing utilization,
complexity of drug administration, and patient acuity, as determined by
the different categories based on therapy type. Retaining the three
current payment categories would maintain consistency with the already
established payment methodology and ensure a smooth transition between
the temporary transitional payments and the permanent payment system to
be implemented beginning with 2021. Therefore, we propose to carry
forward the three temporary transitional payment categories for the
home infusion therapy services payment in CY 2021. Table 28 provides
the list of J-codes associated with the infusion drugs that fall within
each of the payment categories. There are several drugs that are paid
for under the transitional benefit but would not be defined as a home
infusion drug under the permanent benefit beginning with 2021. As noted
previously in this proposed rule, section 1861(iii)(3)(C) of the Act
defines a home infusion drug as a parenteral drug or biological
administered intravenously or subcutaneously for an administration
period of 15 minutes or more, in the home of an individual through a
pump that is an item of DME. Such term does not include the following:
(1) Insulin pump systems; and (2) a self-administered drug or
biological on a self-administered drug exclusion list. Hizentra, a
subcutaneous immunoglobulin, is not included in this definition of home
infusion drugs because it is listed on a self-administered drug (SAD)
exclusion list by the MACs. This drug was included as a transitional
home infusion drug since the definition of such drug in section
1834(u)(7)(A)(iii) of the Act does not exclude self-administered drugs
or biologicals on a SAD exclusion list under the temporary transitional
payment. Therefore, although home infusion therapy services related to
the administration of Hizentra are covered under the temporary
transitional payment, because it is on a SAD exclusion list, services
related to the administration of this biological are not covered under
the benefit in 2021. Similarly, in accordance with the definition of
``home infusion drug'' as a parenteral drug or biological administered
intravenously or subcutaneously, home infusion therapy services related
to the administration of Ziconotide and Floxuridine are also excluded,
as these drugs are given via intrathecal and intra-arterial routes
respectively and therefore do not meet the definition of home infusion
drug. Subsequent drugs added to the DME LCD for external infusion
pumps, and compounded infusion drugs not otherwise classified, as
identified by HCPCS codes J7799 and J7999, will be grouped into the
appropriate payment category by the DME MACs. Payment category 1 would
include any subsequent intravenous infusion drug additions, payment
category 2 would include any subsequent subcutaneous infusion drug
additions, and payment category 3 would include any subsequent
intravenous chemotherapy infusion drug additions.
[[Page 34696]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.071
    We are soliciting comments on retaining the three payment
categories, as identified in Table 28, in CY 2021.
1. Proposed Payment Amounts
    As described previously, section 1834(u)(1)(A)(ii) of the Act
requires that the payment amount take into account variation in
utilization of nursing services by therapy type. Additionally, section
1834(u)(1)(A)(iii) of the Act provides a limitation that the single
payment shall not exceed the amount determined under the fee schedule
under section 1848 of the Act for infusion therapy services furnished
in a calendar day if furnished in a physician office setting, except
such single payment shall not reflect more than 5 hours of infusion for
a particular therapy in a calendar day. Finally, section
1834(u)(1)(B)(ii) of the Act requires the payment amount to reflect
patient acuity and complexity of drug administration.
    The language at section 1834(u)(1)(A)(ii) of the Act is consistent
with section 1834(u)(7)(B)(iv) of the Act, which establishes a ``single
payment amount'' for the temporary transitional payment for an infusion
drug administration calendar day. Currently, as set out at section
1834(u)(7)(D) of the Act, each temporary transitional payment category
is paid at amounts in accordance with six infusion CPT codes and units
of such codes under the PFS. These payment category amounts are set
equal to 4 hours of infusion therapy administration services in a
physician's office for each infusion drug administration calendar day,
regardless of the length of the visit. We stated in the CY 2019 final
rule (83 FR 56581) that a ``single payment amount'' means that all home
infusion therapy services, which include professional services,
including nursing; training and education; remote monitoring; and
monitoring, are built into the day on which the services are furnished
in the home and the drug is being administered. In other words, payment
for an infusion drug administration
[[Page 34697]]
calendar day is a bundled payment amount per visit. As such, because
payment for an infusion drug administration calendar day under the
permanent benefit is also a ``unit of single payment,'' we propose to
carry forward the payment methodology as outlined in section
1834(u)(7)(A) of the Act for the temporary transitional payments. We
propose to pay a single payment amount for each infusion drug
administration calendar day in the individual's home for drugs assigned
under each proposed payment category. Each proposed payment category
amount would be in accordance with the six infusion CPT codes
identified in section 1834(u)(7)(D) of the Act and as shown in Table
29. However, because section 1834(u)(1)(A)(iii) of the Act states that
the single payment shall not exceed more than 5 hours of infusion for a
particular therapy in a calendar day, we propose that the single
payment amount be set at an amount equal to 5 hours of infusion therapy
administration services in a physician's office for each infusion drug
administration calendar day.
    We believe that proposing a single unit of payment equal to 5 hours
of infusion therapy services in a physician's office is a reasonable
approach to account for the bundled services included under the home
infusion therapy benefit, as described previously. We also understand
that some patients may require more care coordination or longer visits
than other patients, and while the physician payments would account for
varying time spent furnishing care for individual patients (both during
a visit and outside of a visit) in accordance with the specific PFS
codes they bill, payment for an infusion drug administration calendar
day is a unit of single payment and would not vary within each
category. While the payment amounts do vary between categories to
account for differences in therapy type, paying the maximum amount
allowed by statute acknowledges the varying care needs of each
individual patient within each category. For example, a qualified home
infusion therapy supplier furnishing care for a patient receiving a
category 2 infusion drug would receive a single payment amount for each
infusion drug administration calendar day in the patient's home.
However, this payment amount would not reflect the varying degrees of
care among individual patients within each category, or from visit to
visit for the same patient. And while the payment rates for each of the
three payment categories is higher than the home health per-visit
nursing rate, the home infusion therapy rates reflect the increased
complexity of the professional services provided per category, and as
required by law.
    Furthermore, furnishing care in the patient's home is fundamentally
different from furnishing care in the physician's office. Healthcare
professionals cannot achieve the economies of scale in the home that
can be achieved in an office setting. As noted previously, the single
unit of payment for each of the three categories is a bundled payment,
meaning payment is made on the basis of expected costs for clinically-
defined episodes of care, where some episodes of care for similar
patients with similar care needs cost more than others. While the
single unit of payment for the temporary transitional payments was set
at 4 hours by law, the payment amount for home infusion therapy
services beginning in CY 2021 cannot exceed 5 hours of infusion for a
particular therapy. As such, the law provides more latitude for the
payment of home infusion therapy services beginning in CY 2021. To
ensure that payment for home infusion therapy adequately covers the
different patient care needs and level of complexity of services
provided, we are proposing that the bundled payment amount for home
infusion therapy services furnished on and after January 1, 2021 should
be set at the maximum allowed by statute, 5 hours, in order to account
for these differences and still remain a unit of single payment.
    Setting the payment amounts for each proposed payment category in
accordance with the CPT infusion code amounts under the PFS accounts
for variation in utilization of nursing services, patient acuity, and
complexity of drug administration. CPT codes establish uniformity of
the services that fall under each code in order to determine the amount
of payment that a practitioner will receive for such services. Medicare
PFS valuation of CPT codes uses a combination of the time and
complexity used to furnish the service, as well as the amount and value
of resources used. Relative value units (RVUs) are calculated for three
components used to determine the value of a CPT code. One component,
the non-facility practice expense RVU, is based, in part, on the amount
and complexity of services furnished by nursing and ancillary clinical
staff involved in the procedure or service.\220\ The CPT infusion codes
under the PFS weight the non-facility practice expense RVUs more
heavily than the other two components, which include physician work and
malpractice expense.\221\ Therefore, the values of the CPT infusion
code amounts, in accordance with the different payment categories,
reflect variations in nursing utilization, patient acuity, and
complexity of drug administration, as they are directly proportionate
to the clinical labor involved in furnishing the infusion services in
the patient's home.
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    \220\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3096340/.
    \221\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files-Items/RVU19A.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending.
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[[Page 34698]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.072
    The payment methodology outlined previously meets the required
payment adjustments, while remaining a single unit of payment. However,
we recognize that often the first visit furnished by a home infusion
therapy supplier to furnish services in the patient's home may be
longer or more resource intensive than subsequent visits. In
particular, patients with new diagnoses may require more disease
education, instruction on self-monitoring, and support from healthcare
professionals. Patients who have not been hospitalized may be starting
home infusion therapy without the benefit of having received any
training or education prior to discharge. Additionally, considering
that hospitals often discharge quickly once outside services are in
place, patients who have started infusion therapy in the hospital, may
arrive home with central vascular access devices and ambulatory pumps
without sufficient education or instruction regarding maintenance or
lifestyle changes. This could potentially lead to safety issues or an
increase in doctor's office or emergency department visits. Therefore,
the single payment amount discussed previously may not adequately
compensate for the first patient visit furnished by the qualified home
infusion therapy supplier in the patient's home. Section 1834(u)(1)(C)
of the Act allows the Secretary discretion to adjust the single payment
amount to reflect outlier situations and other factors as the Secretary
determines appropriate, in a budget neutral manner. Payment for
infusion therapy in the physician's office reflects whether a patient
is new or existing, acknowledging that new patients may initially
require more time and education. Therefore, we propose increasing the
payment amounts for each of the three payment categories for the first
visit by the relative payment for a new patient rate over an existing
patient rate using the physician evaluation and management (E/M)
payment amounts for a given year. Overall this adjustment would be
budget-neutral, in accordance with the requirement at section
1834(u)(1)(C)(ii) of the Act, resulting in a small decrease to the
payment amounts for any subsequent visits. This would be similar to the
LUPA add-on payment under the home health benefit, which is paid for
the first LUPA episode in a sequence of adjacent episodes or episodes
that occur as the only episode. It is important to note that the first
visit payment amount is only issued on the first home visit to initiate
home infusion therapy services furnished by the qualified home infusion
therapy supplier. Any changes in the plan of care or drug regimen,
including the addition of drugs or biologicals that may change the
payment category, would not trigger a first visit payment amount. If a
patient receiving home infusion therapy services is discharged, the
home infusion therapy services claim must show a patient status code to
indicate a discharge with a gap of more than 60 days in order to bill a
first visit again if the patient is readmitted. This means that upon
re-admission, there cannot be a G-code billed for this patient in the
past 60 days, and the last G-code billed for this patient must show
that the patient had been discharged. A qualified home infusion therapy
supplier could bill the first visit payment amount on day 61 for a
patient who had previously been discharged from service. We also
recognize that many beneficiaries have been receiving services during
the temporary transitional payment period, and as a result, many of
these patients already have a working knowledge of their pump and may
need less start-up time with the nurse during their initial week of
visits during the permanent benefit. Therefore, suppliers would not be
able to bill for the initial visit amount for those patients who have
been receiving services under the temporary transitional payment, and
have billed a G-code within the past 60 days. Table 30 shows the E/M
visit codes and PFS payment amounts for CY 2019, for both new and
existing patients, used to determine the increased payment amount for
the first visit. Using the CY 2019 PFS rates, this results in a 60
percent increase in the first visit payment amount and a 3.76 percent
decrease in subsequent visit amounts.
[[Page 34699]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.073
    In summary, we propose that the payment amounts per category, for
an infusion drug administration calendar day under the permanent
benefit, be in accordance with the six PFS infusion CPT codes and units
for such codes, as described in section 1834(u)(7)(D) of the Act;
however, we propose to set the amount equivalent to 5 hours of infusion
in a physician's office, rather than 4 hours. We also propose
increasing the payment amounts for each of the three payment categories
for the first home infusion therapy visit by the qualified home
infusion therapy supplier in the patient's home by the average
difference between the PFS amounts for E/M existing patient visits and
new patient visits for a given year, resulting in a small decrease to
the payment amounts for the second and subsequent visits, using a
budget neutrality factor. Table 31 shows the 5 hour payment amounts
(using CY 2019 rates) reflecting the increased payment for the first
visit and the decreased payment for all subsequent visits. We plan on
monitoring home infusion therapy service lengths of visits, both
initial and subsequent, in order to evaluate whether the data
substantiates this increase or whether we should re-evaluate whether,
or how much, to increase the initial visit payment amount. We are
soliciting comments on the proposed CY 2021 payment amounts per
category, including the proposed payment equivalent to 5 hours of
infusion in a physician's office and increasing the payment amounts for
each of the three categories for the first home infusion therapy visit
by the average difference between the PFS amounts for E/M existing
patient visits and new patient visits for a given year.
---------------------------------------------------------------------------
    \222\ This represents the average difference between the
physician E/M payment amounts for new versus established patients:
(the sum of the initial rates - the sum of the existing rates)/(the
sum of the existing rates) = 60%.
[GRAPHIC] [TIFF OMITTED] TP18JY19.074
[[Page 34700]]
E. Required Payment Adjustments for CY 2021 Home Infusion Therapy
Services
1. Proposed Home Infusion Therapy Geographic Wage Index Adjustment
    Section 1834(u)(1)(B)(i) of the Act requires that the single
payment amount be adjusted to reflect a geographic wage index and other
costs that may vary by region. In the 2019 HH PPS proposed rule (83 FR
32467) we stated that we were considering using the Geographic Practice
Cost Indices (GPCIs) to account for regional variations in wages and
adjust the payment for home infusion therapy professional services;
however, after further analysis and consideration we believe the
geographic adjustment factor (GAF) may be a more appropriate option to
adjust home infusion therapy payments based on differences in
geographic wages.
    The GAF is a weighted composite of each PFS locality's work,
practice expense (PE), and malpractice (MP) GPCIs and represents the
combined impact of the three GPCI components. The GAF is calculated by
multiplying the work, PE and MP GPCIs by the corresponding national
cost share weight: Work (50.886 percent), PE (44.839 percent), and MP
(4.295 percent).\223\ The work GPCI reflects the relative costs of
physician labor by region. The PE GPCI measures the relative cost
difference in the mix of goods and services comprising practice
expenses among the PFS localities as compared to the national average
of these costs. The MP GPCI measures the relative regional cost
differences in the purchase of professional liability insurance (PLI).
The GAF is updated at least every 3 years per statute and reflects a
1.5 work GPCI floor for services furnished in Alaska as well as a 1.0
PE GPCI floor for services furnished in frontier states (Montana,
Nevada, North Dakota, South Dakota and Wyoming). The GAF is not
specific to any of the home infusion drug categories, so the GAF
payment rate would equal the unadjusted rate multiplied by the GAF for
each locality level, without a labor share adjustment. As such, based
on locality, the GAF adjusted payment rate would be calculated using
the following formula:
---------------------------------------------------------------------------
    \223\ GAF = (.50886 x Work GPCI) + (.44839 x PE GPCI) + (.04295
x MP GPCI)
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RateiGAF = GAF * UnadjRatei
    We would apply the appropriate GAF value to the home infusion
therapy single payment amount based on the site of service of the
beneficiary. There are currently 112 total PFS localities, 34 of which
are statewide areas (that is, only one locality for the entire state).
There are 10 states with 2 localities, 2 states having 3 localities, 1
state having 4 localities, and 3 states having 5 or more localities.
The combined District of Columbia, Maryland, and Virginia suburbs;
Puerto Rico; and the Virgin Islands are the remaining three localities.
Beginning in 2017, California's locality structure was modified to
increase its number of localities from 9, under the previous locality
structure, to 27 under the new Metropolitan Statistical Area based
locality structure defined by the Office of Management and Budget
(OMB).
    The list of GAFs by locality for this proposed rule is available as
a downloadable file at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
    We considered other alternatives to using the GAF (as discussed in
section VIII.E) such as the hospital wage index (HWI), the GPCI, and
using just the practice expense component of the GPCI; however, we are
proposing to use the GAF to geographically wage adjust home infusion
therapy for CY 2021 and subsequent years. We believe the GAF is the
best option for geographic wage adjustment because it is the most
operationally feasible. Utilizing the GAF would allow adjustments to be
made while leveraging systems that are already in place. There are
already mechanisms in place to geographically adjust using the GAF and
applying this option would require less system changes. The adjustment
would happen on the PFS and be based on the beneficiary zip code
submitted on the 837P/CMS-1500 professional and supplier claims form.
    Table 32 shows the 2019 rates for the temporary, transitional
payment by drug category. Using the 2019 rates for the temporary,
transitional payments, we estimate what the adjusted payments rates
would be using the GAF. Table 33 shows the distribution of standardized
adjusted payment rates for the GAF (sorted by standard deviation). The
results indicate the distribution of payment rates center around the
unadjusted payment rates when adjusting using the GAF.
[GRAPHIC] [TIFF OMITTED] TP18JY19.075
[[Page 34701]]
[GRAPHIC] [TIFF OMITTED] TP18JY19.076
    The GAF is further discussed in the CY 2017 PFS final rule (81 FR
80170). Specific GAF values for each payment locality in past years are
posted in Addendum D to this proposed rule and can be found at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
The final CY 2020 GAF rates will be posted when they become available.
    We are proposing that the application of the geographic wage
adjustment be budget neutral so there would be no overall cost impact.
However, this will result in some adjusted payments being higher than
the average and others being lower. In order to make the application of
the GAF budget neutral we are going to apply a budget-neutrality
factor. If the rates were set for 2020 the budget neutrality factor
would be 0.9985. The budget neutrality factor will be recalculated for
2021 in next year's rule using 2019 utilization data from the first
year of the temporary transitional payment period. We welcome comments
on our proposal to use the GAF to wage adjust the home infusion therapy
services payment, and commenter's suggestions on whether a factor other
than the GAF should be used.
2. Consumer Price Index
    Subparagraphs (A) and (B) of section 1834(u)(3) of the Act specify
annual adjustments to the single payment amount that are required to be
made beginning January 1, 2022. In accordance with these sections we
would increase the single payment amount by the percent increase in the
Consumer Price Index for all urban consumers (CPI-U) for the 12-month
period ending with June of the preceding year, reduced by the 10-year
moving average of changes in annual economy-wide private nonfarm
business multifactor productivity (MFP). Accordingly, this may result
in a percentage being less than 0.0 for a year, and may result in
payment being less than such payment rates for the preceding year.
F. Other Optional Payment Adjustments/Prior Authorization for CY 2021
Home Infusion Therapy Services
1. Prior Authorization
    Section 1834(u)(4) of the Act allows the Secretary discretion, as
appropriate, to apply prior authorization for home infusion therapy
services. Generally, prior authorization requires that a decision by a
health insurer or plan be rendered to confirm health care service,
treatment plan, prescription drug, or durable medical equipment is
medically necessary.\224\ Prior authorization helps to ensure that a
service, such as home infusion therapy, is being provided
appropriately.
---------------------------------------------------------------------------
    \224\ https://www.healthcare.gov/glossary/preauthorization/.
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    In the 2019 HH PPS proposed rule (83 FR 32469), we solicited
comments as to whether and how prior authorization could potentially be
used in home infusion. The majority of commenters were concerned that
applying prior authorization would risk denying or delaying timely
access to needed services, as an expeditious transition of care is
clinically and economically important in home infusion. Another
commenter stated that a CMS process would be welcome assuming the
clinical information required is clearly defined, there is a defined
CMS response time that does not prevent timely clinical care, that the
process is appropriately limited to higher cost drugs, and once prior
authorization has been made, retroactive denial for medical necessity
would not be allowed.
    Ultimately, we do not consider prior authorization to be
appropriate for the home infusion therapy benefit, at this time, as the
benefit is contingent on the requirement that a home infusion drug or
biological be administered through a Medicare Part B covered pump that
is an item of DME. As discussed in section VI.E. of this proposed rule,
payment for Medicare home infusion therapy is for services furnished in
coordination with the furnishing of the infusion drugs and biologicals
specified on the DME LCD for External Infusion Pumps (L33794), with the
exception of insulin pump systems or any drugs or biologicals on a
self-administered drug exclusion list. Therefore, we believe that prior
authorization for home infusion therapy services is not necessary at
this time, as services are contingent on the requirements under the DME
benefit. We will monitor the provision of home infusion therapy
services and revisit the need for prior authorization if issues arise.
2. Payments for High-Cost Outliers for Home Infusion Therapy Services
    Section 1834(u)(1)(C) of the Act allows for discretionary
adjustments which may include outlier situations and other factors as
the Secretary determines appropriate. In the 2019 HH PPS proposed rule
(83 FR 32467) we requested feedback on situations that may incur an
outlier payment and potential designs for an outlier payment
calculation. We received a comment stating that ``it would be premature
to consider outlier payments for home infusion therapy at the outset of
the payment system. Given that the scope of covered home infusion
therapy services is limited, and CMS is required to adjust the payment
amount for patient acuity and complexity of drug administration, there
may not be a need for outlier payments.'' We agree with this commenter
that high cost outlier payments are not necessary at this time. We plan
to monitor the need for such payments and if necessary address outlier
situations in future rule making.
G. Billing Procedures for CY 2021 Home Infusion Therapy Services
    In the CY 2019 HH PPS proposed rule we discussed billing procedures
for home infusion therapy services for CY 2021 and subsequent years (83
FR 32467). We stated that we were considering processing claims for
home
[[Page 34702]]
infusion therapy services submitted on a Part B practitioner claim
through the A/B MACs, rather than the DME MACs, given that ``qualified
home infusion therapy suppliers'' are not limited to DME suppliers. We
recognized that, although a qualified home infusion therapy supplier is
not required to furnish DME equipment and supplies, in order for the
same supplier to bill for both the home infusion therapy services and
the DME equipment and supplies (including the drug), the provider or
supplier would need to be enrolled as both a Part B qualified home
infusion therapy supplier and as a DME supplier. In these instances,
the same supplier would need to submit separate claims to both the A/B
MACs and the DME MACs. We solicited comments on whether it is
reasonable to require separate claims submissions to both the DME MACs
and the A/B MACs for processing.
    We received a few comments regarding this billing process, both in
support of requiring separate claims submissions through the DME MACs
and the A/B MACs. We continue to believe that, as a qualified home
infusion therapy supplier is only required to enroll in Medicare as a
Part B supplier, and is not required to enroll as a DME supplier, it is
more practicable to process home infusion therapy service claims
through the A/B MACs and the Multi-Carrier System (MCS) for Medicare
Part B claims. DME suppliers, also enrolled as qualified home infusion
therapy suppliers, would continue to submit DME claims through the DME
MACs; however, they would also be required to submit home infusion
therapy service claims to the A/B MACs for processing. Therefore, we
plan to require that the qualified home infusion therapy supplier would
submit all home infusion therapy service claims on the 837P/CMS-1500
professional and supplier claims form to the A/B MACs. DME suppliers,
concurrently enrolled as qualified home infusion therapy suppliers,
would need to submit one claim for the DME, supplies, and drug on the
837P/CMS-1500 professional and supplier claims form to the DME MAC and
a separate 837P/CMS-1500 professional and supplier claims form for the
professional services to the A/B MAC. Because the home infusion therapy
services are contingent upon a home infusion drug J-code being billed,
home infusion therapy suppliers must ensure that the appropriate drug
associated with the visit is billed with the visit or no more than 30
days prior to the visit. Additionally, we plan to add the home infusion
G-codes to the PFS, incorporating the required annual and geographic
wage adjustments. Home infusion therapy suppliers would include a
modifier on the appropriate G-code to differentiate the first visit
from all subsequent visits, as well as a modifier to indicate when a
patient has been discharged from service. This would be necessary in
order for the qualified home infusion therapy supplier to bill for the
first visit payment amount for a patient who had previously received
home infusion therapy services in order to demonstrate a gap of more
than 60 days between a discharge and the start of subsequent home
infusion therapy services. We will issue a Change Request (CR)
providing more detailed instruction regarding billing and policy
information for home infusion therapy services, which is expected upon
release of the CY 2020 final rule.
VII. Collection of Information Requirements
    Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 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.
    In section V. of this proposed rule, we propose changes and updates
to the HH QRP. We believe that the burden associated with the HH QRP
proposals is the time and effort associated with data collection and
reporting. As of February 1, 2019, there are approximately 11,385 HHAs
reporting quality data to CMS under the HH QRP. 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 2017 National Occupational
Employment and Wage Estimates (https://www.bls.gov/oes/2017/may/oes_nat.htm). To account for overhead and fringe benefits (100
percent), we have doubled the hourly wage. These amounts are detailed
in Table 34.
[GRAPHIC] [TIFF OMITTED] TP18JY19.077
    As discussed in section V.D. of this proposed rule, we are
proposing to remove the Improvement in Pain Interfering with Activity
Measure (NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP
under our measure removal Factor 7: Collection or public reporting of a
measure leads to negative unintended consequences other than patient
harm. Additionally, we are proposing to remove OASIS item M1242.
Removing M1242 will result in a decrease in burden of 0.3 minutes of
clinical staff time to report data at start of care (SOC), 0.3 minutes
of clinical staff time to report data at resumption of care (ROC) and
0.3 minutes of clinical staff time to report data at Discharge.
[[Page 34703]]
    As discussed in section V.E. of this proposed rule, we are
proposing to adopt two new measures: (1) Transfer of Health Information
to Provider--Post-Acute Care (PAC); and (2) Transfer of Health
Information to Patient--Post-Acute Care (PAC), beginning with the CY
2022 HH QRP. We estimate the data elements for the proposed Transfer of
Health Information quality measures will take 0.6 minutes of clinical
staff time to report data at Discharge and 0.3 minutes of clinical
staff time to report data at Transfer of Care (TOC).
    In section V.G. of this proposed rule, we are proposing to collect
standardized patient assessment data beginning with the CY 2022 HH QRP.
We estimate the proposed SPADEs will take 10.05 minutes of clinical
staff time to report data at SOC, 9.15 minutes of clinical staff time
to report at ROC, and 11.25 minutes of clinical staff time to report
data at Discharge.
    We estimate that there would be a net increase in clinician burden
per OASIS assessment of 9.75 minutes at SOC, 8.85 minutes at ROC, 0.3
minutes at TOC, and 11.55 minutes at Discharge as a result of all of
the HH QRP proposals in this proposed rule.
    The OASIS is completed by RNs or PTs, or very occasionally by
occupational therapists (OT) or speech language pathologists (SLP/ST).
Data from 2018 show that the SOC/ROC OASIS is completed by RNs
(approximately 84.5 percent of the time), PTs (approximately 15.2
percent of the time), and other therapists, including OTs and SLP/STs
(approximately 0.3 percent of the time). Based on this analysis, we
estimated a weighted clinician average hourly wage of $72.90, inclusive
of fringe benefits, using the hourly wage data in Table 34. Individual
providers determine the staffing resources necessary.
    Table 35 shows the total number of OASIS assessments submitted by
HHAs in CY 2018 and estimated burden at each time point.
[GRAPHIC] [TIFF OMITTED] TP18JY19.078
    Based on the data in Table 35, for the 11,385 active Medicare-
certified HHAs in February 2019, we estimate the total average increase
in cost associated with changes to the HH QRP at approximately
$14,923.00 per HHA annually, or $169,898,354.17 for all HHAs annually.
This corresponds to an estimated increase in clinician burden
associated with proposed changes to the HH QRP of approximately 204.7
hours per HHA annually, or 2,330,567.3 hours for all HHAs annually.
This estimated increase in burden will be accounted for in the
information collection under OMB control number 0938-1279.
VIII. Regulatory Impact Analysis
A. Statement of Need
1. Home Health Prospective Payment System (HH PPS)
    Section 1895(b)(1) of the Act requires the Secretary to establish a
HH PPS for all costs of home health services paid under Medicare. In
addition, section 1895(b) of the Act requires: (1) The computation of a
standard prospective payment amount include all costs for home health
services covered and paid for on a reasonable cost basis and that such
amounts be initially based on the most recent audited cost report data
available to the Secretary; (2) the prospective payment amount under
the HH PPS to be an appropriate unit of service based on the number,
type, and duration of visits provided within that unit; and (3) the
standardized prospective payment amount be adjusted to account for the
effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B)
of the Act addresses the annual update to the standard prospective
payment amounts by the HH applicable percentage increase. Section
1895(b)(4) of the Act governs the payment computation. Sections
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard
prospective payment amount to be adjusted for case-mix and geographic
differences in wage levels. Section 1895(b)(4)(B) of the Act requires
the establishment of appropriate case-mix adjustment factors for
significant variation in costs among different units of services.
Lastly, section 1895(b)(4)(C) of the Act requires the establishment of
wage adjustment factors that reflect the relative level of wages, and
wage-related costs applicable to home health services furnished in a
geographic area compared to the applicable national average level.
    Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with
the authority to implement adjustments to the standard prospective
payment amount (or amounts) for subsequent years to eliminate the
effect of changes in aggregate payments during a previous year or years
that were the result of changes in the coding or classification of
different units of services that do not reflect real changes in case-
mix. Section 1895(b)(5) of the Act provides the Secretary with the
option to make changes to the payment amount otherwise paid in the case
of outliers because of unusual variations in the type or amount of
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires
HHAs to submit data for purposes of measuring health care quality, and
links the quality data submission to the annual applicable percentage
increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires
the Secretary to implement a new methodology used to determine rural
add-on payments for CYs 2019 through 2022.
    Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by
section
[[Page 34704]]
51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, require
the Secretary to implement a 30-day unit of service, effective for CY
2020, and calculate a 30-day payment amount for CY 2020 in a budget
neutral manner, respectively. In addition, section 1895(b)(4)(B) of the
Act, as amended by section 51001(a)(3) of the BBA of 2018 requires the
Secretary to eliminate the use of the number of therapy visits provided
to determine payment, also effective for CY 2020.
2. HHVBP
    The HHVBP Model applies a payment adjustment based on an HHA's
performance on quality measures to test the effects on quality and
expenditures.
3. HH QRP
    Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data
for purposes of measuring health care quality, and links the quality
data submission to the annual applicable percentage increase.
4. Home Infusion Therapy
    Section 1834(u)(1) of the Act, as added by section 5012 of the 21st
Century Cures Act, requires the Secretary to establish a home infusion
therapy services payment system under Medicare. Under this payment
system a single payment would be made to a qualified home infusion
therapy supplier for items and services furnished by a qualified home
infusion therapy supplier in coordination with the furnishing of home
infusion drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit
of single payment is for each infusion drug administration calendar day
in the individual's home. The Secretary shall, as appropriate,
establish single payment amounts for types of infusion therapy,
including to take into account variation in utilization of nursing
services by therapy type. Section 1834(u)(1)(A)(iii) of the Act
provides a limitation to the single payment amount, requiring that it
shall not exceed the amount determined under the Physician Fee Schedule
(under section 1848 of the Act) for infusion therapy services furnished
in a calendar day if furnished in a physician office setting, except
such single payment shall not reflect more than 5 hours of infusion for
a particular therapy in a calendar day. Section 1834(u)(1)(B)(i) of the
Act requires that the single payment amount be adjusted by a geographic
wage index. Finally, section 1834(u)(1)(C) of the Act allows for
discretionary adjustments which may include outlier payments and other
factors as deemed appropriate by the Secretary, and are required to be
made in a budget neutral manner. This payment system would become
effective for home infusion therapy items and services furnished on or
after January 1, 2021.
    Section 50401 of the BBA of 2018 amended section 1834(u) of the
Act, by adding a new paragraph (7) that establishes a home infusion
therapy temporary transitional payment for eligible home infusion
therapy suppliers for items and services associated with the furnishing
of transitional home infusion drugs for CYs 2019 and 2020. Under this
payment methodology (as described in section VI.B. of this proposed
rule), the Secretary established three payment categories at amounts
equal to the amounts determined under the Physician Fee Schedule
established under section 1848 of the Act. This rule would continue
this categorization for services furnished during CY 2020 for codes and
units of such codes, determined without application of the geographic
adjustment.
B. Overall Impact
    We have examined the impacts 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). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. Given that we note the
follow costs associated with the provisions of this proposed rule:
     A regulatory impact analysis (RIA) must be prepared for
major rules with economically significant effects ($100 million or more
in any 1 year). We estimate that this rulemaking is ``economically
significant'' as measured by the $100 million threshold, and hence also
a major rule under the Congressional Review Act. Accordingly, we have
prepared a Regulatory Impact Analysis that to the best of our ability
presents the costs and benefits of the rulemaking.
    The net transfer impact related to the changes in payments under
the HH PPS for CY 2020 is estimated to be $250 million (1.3 percent).
The net transfer impact in CY 2020 related to the change in the unit of
payment under the proposed PDGM is estimated to be $0 million as
section 51001(a) of the BBA of 2018 requires such change to be
implemented in a budget-neutral manner.
     HHVBP--The savings impacts related to the HHVBP Model as a
whole are estimated at $378 million for CYs 2018 through 2022. We do
not believe the proposal in this proposed rule would affect the prior
estimate.
     HH QRP--The cost impact for HHA's related to proposed
changes to the HH QRP are estimated at $169.9 million.
     Home Infusion Therapy--The CY 2020 cost impact related to
the routine updates to the temporary transitional payments for home
infusion therapy in CY 2020 is estimated to be less than $1 million in
either an increase or a decrease in payments to home infusion therapy
suppliers, depending on the final payment rates under the physician fee
schedule for CY 2020. The cost impact in CY 2021 related to the
implementation of the permanent home infusion therapy benefit is
estimated to be a $3 million reduction in payments to home infusion
therapy suppliers (using the CY 2019 physician fee schedule payment
amounts as the 2020 physician fee schedule amounts were not available
at the time of rulemaking).
[[Page 34705]]
C. Anticipated Effects
1. HH PPS
    The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number 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 one year.
For the purposes of the RFA, we estimate that almost all HHAs and home
infusion therapy suppliers are small entities as that term is used in
the RFA. Individuals and states are not included in the definition of a
small entity. The economic impact assessment is based on estimated
Medicare payments (revenues) and HHS's practice in interpreting the RFA
is to consider effects economically ``significant'' only if greater
than 5 percent of providers reach a threshold of 3 to 5 percent or more
of total revenue or total costs. The majority of HHAs' visits are
Medicare paid visits and therefore the majority of HHAs' revenue
consists of Medicare payments. Based on our analysis, we conclude that
the policies proposed in this rule would result in an estimated total
impact of 3 to 5 percent or more on Medicare revenue for greater than 5
percent of HHAs and home infusions therapy suppliers. Therefore, the
Secretary has determined that this HH PPS proposed rule would 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 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 and has fewer
than 100 beds. This rule is not applicable to hospitals. Therefore, the
Secretary has determined this final rule will not have a significant
economic impact on the operations of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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 2019, that
threshold is approximately $150 million. This rule is not anticipated
to have an effect on State, local, or tribal governments, in the
aggregate, or on the private sector of $150 million or more.
    Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates 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. We have reviewed this proposed rule under these criteria
of Executive Order 13132, and have determined that it will not impose
substantial direct costs on state or local governments.
2. HHVBP
    Under the HHVBP Model, the first payment adjustment was applied in
CY 2018 based on PY 1 (2016) data and the final payment adjustment will
apply in CY 2022 based on PY 5 (2020) data. In the CY 2016 HH PPS final
rule, we estimated that the overall impact of the HHVBP Model from CY
2018 through CY 2022 was a reduction of approximately $380 million (80
FR 68716). In the CYs 2017, 2018, and 2019 HH PPS final rules, we
estimated that the overall impact of the HHVBP Model from CY 2018
through CY 2022 was a reduction of approximately $378 million (81 FR
76795, 82 FR 51751, and 83 FR 56593, respectively). We do not believe
the proposal in this proposed rule would affect the prior estimate.
3. Regulatory Review Cost Estimation
    If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this final rule, we must
estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that would review the rule, we assume that the total number of unique
reviewers of this year's proposed rule would be the similar to the
number of commenters on last year's 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 this 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 believe 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 would 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 $109.36 per hour, including overhead and
fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). Assuming
an average reading speed of 250 words per minute, we estimate that it
would take approximately 3.53 hours for the staff to review half of
this proposed rule, which consists of approximately 105,837 words. For
each HHA that reviews the rule, the estimated cost is $386.04 (3.53
hours x $109.36). Therefore, we estimate that the total cost of
reviewing this proposed rule is $442,015.80 ($386.04 x 1,145
reviewers). For purposes of this estimate, the number of anticipated
reviewers in this year's rule is equivalent to the number of commenters
on the CY 2019 HH PPS proposed rule.
D. Detailed Economic Analysis
1. HH PPS
    This rule proposes updates to Medicare payments under the HH PPS
for the CY 2020. This rule also implements a change in the case-mix
adjustment methodology for home health periods of care beginning on and
after January 1, 2020 and implements the change in the unit of payment
from 60-day episodes to 30-day periods. These changes are made in a
budget-neutral manner. The impact analysis of this proposed rule
presents the estimated expenditure effects of policy changes proposed
in this rule. We use the latest data and best analysis available, but
we do not make adjustments for future changes in such variables as
number of visits or case-mix.
    This analysis incorporates the latest estimates of growth in
service use and payments under the Medicare HH benefit, based primarily
on Medicare claims data from 2018. We note that certain events may
combine to limit the scope or accuracy of our impact analysis, because
such an analysis is future-oriented and, thus, susceptible to errors
resulting from other changes in the impact time period assessed. Some
examples of such possible events are newly-legislated general Medicare
program funding changes made by the Congress, or changes specifically
related to HHAs. In addition, changes to the Medicare program may
continue to be made as a result of the Affordable Care Act, or new
statutory provisions.
[[Page 34706]]
Although these changes may not be specific to the HH PPS, the nature of
the Medicare program is such that the changes may interact, and the
complexity of the interaction of these changes could make it difficult
to predict accurately the full scope of the impact upon HHAs.
    Table 36 represents how HHA revenues are likely to be affected by
the policy changes proposed in this rule for CY 2020. For this
analysis, we used an analytic file with linked CY 2018 OASIS
assessments and HH claims data for dates of service that ended on or
before December 31, 2018. The first column of Table 36 classifies HHAs
according to a number of characteristics including provider type,
geographic region, and urban and rural locations. The second column
shows the number of facilities in the impact analysis. The third column
shows the payment effects of the CY 2020 wage index. The fourth column
shows the payment effects of the CY 2020 rural add-on payment provision
in statute. The fifth column shows the effects of the implementation of
the PDGM case-mix methodology for CY 2020. The sixth column shows the
payment effects of the CY 2020 home health payment update percentage as
required by section 53110 of the BBA of 2018. And the last column shows
the combined effects of all the policies proposed in this rule.
    Overall, it is projected that aggregate payments in CY 2020 would
increase by 1.3 percent. As illustrated in Table 36, the combined
effects of all of the changes vary by specific types of providers and
by location. We note that some individual HHAs within the same group
may experience different impacts on payments than others due to the
distributional impact of the CY 2020 wage index, the extent to which
HHAs are affected by changes in case-mix weights between the current
153-group case-mix model and the case-mix weights under the 432-group
PDGM, the percentage of total HH PPS payments that were subject to the
low-utilization payment adjustment (LUPA) or paid as outlier payments,
and the degree of Medicare utilization.
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2. HHVBP
    As discussed in section IV. of this proposed rule, for the HHVBP
Model, we are proposing to publicly report performance data for PY 5
(CY 2020) of the Model. This proposal would not affect our analysis of
the distribution of payment adjustments for PY 5 as presented in the CY
2019 HH PPS final rule. Therefore, we are not providing a detailed
analysis.
3. HH QRP
    Failure to submit data required under section 1895(b)(3)(B)(v) of
the Act with respect to a calendar year will result in the reduction of
the annual home health
[[Page 34708]]
market basket percentage increase otherwise applicable to a HHA for
that calendar year by 2 percentage points. For the CY 2019 payment
determination, 1,286 of the 11,444 active Medicare-certified HHAs, or
approximately 11.2 percent, did not receive the full annual percentage
increase. Information is not available to determine the precise number
of HHAs that would not meet the requirements to receive the full annual
percentage increase for the CY 2020 payment determination.
    As discussed in section V.D. of this proposed rule, we are
proposing to remove one measure beginning with the CY 2022 HH QRP. The
measure we are proposing to remove is Improvement in Pain Interfering
with Activity Measure (NQF #0177). As discussed in section V.E. of this
proposed rule, we are proposing to add two measures beginning with the
CY 2022 HH QRP. The two measures we are proposing to adopt are: (1)
Transfer of Health Information to Provider-Post-Acute Care; and (2)
Transfer of Health Information to Patient-Post-Acute Care. As discussed
in section V.G. of this proposed rule, we are also proposing to collect
standardized patient assessment data beginning with the CY 2022 HH QRP.
Section VII. of this proposed rule provides a detailed description of
the net increase in burden associated with these proposed changes. We
have estimated this associated burden beginning with CY 2021 because
HHAs will be required to submit data beginning with that calendar year.
The cost impact related to OASIS item collection as a result of the
changes to the HH QRP is estimated to be a net increase of
approximately $169.9 million in annualized cost to HHAs, discounted at
7 percent relative to year 2016, over a perpetual time horizon
beginning in CY 2021.
4. Home Infusion Therapy Services Payment
a. Home Infusion Therapy Services Temporary Transitional Payment
    At the time of publication of this proposed rule, the CY 2020 PFS
payment rates were not available, therefore we are unable to estimate
whether the impact in CY 2020 would result in an increase or decrease
in overall payments for home infusion therapy services receiving
temporary transitional payments. However, we estimate the impact due to
the updated payment amounts for furnishing home infusion therapy
services, as determined under the physician fee schedule established
under section 1848 of the Act, may result in up to a $1 million
increase/decrease in payments for CY 2020.
b. Home Infusion Therapy Services Payment for CY 2021 and Subsequent
Years
    The following analysis applies to payment for home infusion therapy
as set forth in section 1834(u)(1) of the Act, as added by section 5012
of the 21st Century Cures Act (Pub. L. 114-255), and accordingly,
describes the preliminary impact for CY 2021 only. We should also note
that as payment amounts are contingent on the Physician Fee Schedule
(PFS) rates, this impact analysis will be affected by whether rates
increase or decrease in CY 2020. At the time of publication these rates
were not available, therefore we used the CY 2019 PFS payment rates for
the purpose of this analysis. We used CY 2018 claims data to identify
beneficiaries with DME claims containing 1 of the 37 HCPCS codes
identified on the DME LCD for External Infusion Pumps (L33794),
excluding drugs that are statutorily excluded from coverage under the
permanent home infusion therapy benefit. These include drugs and
biologicals listed on self-administered drug exclusion lists and drugs
administered by routes other than intravenous or subcutaneous infusion.
Because we do not have complete data for CY 2019 (the first year of the
temporary transitional payments), we used the visit assumptions
identified in the CY 2019 HH PPS final rule. We calculated the total
weeks of care, which is the sum of weeks of care across all
beneficiaries found in each category (as determined from the 2018
claims). Weeks of care for categories 1 and 3 are defined as the week
of the last infusion drug or pump claim minus the week of the first
infusion drug or pump claim plus one. For category 2, we used the
median number of weeks of care and assumed 1 visit per month, or 12
visits per year. And finally, we assumed 2 visits for the initial week
of care, with 1 visit per week for all subsequent weeks in order to
estimate the total visits of care per category. For this analysis, we
did not factor in an increase in beneficiaries receiving home infusion
therapy services due to switching from physician's offices or
outpatient centers. Because home infusion therapy services under
Medicare are contingent on utilization of the DME benefit, we
anticipate utilization will remain fairly stable and that there would
be no significant changes in the settings of care where current
infusion therapy is provided. We will continue to monitor utilization
to determine if referral patterns change significantly once the
permanent benefit is implemented in CY 2021. Table 37 reflects the
estimated wage-adjusted beneficiary impact, representative of a 4-hour
payment rate, compared to a 5-hour payment rate, excluding statutorily
excluded drugs and biologicals. Column 3 represents the percent change
from the estimated CY 2019 payment under the temporary transitional
payment to the estimated CY 2021 payment after applying the GAF wage
adjustment. Column 4 represents the percent change from the estimated
CY 2021 payment after applying the GAF wage adjustment index and the 5
hour payment rate to the estimated payment after removing the
statutorily excluded drugs. Column 5 represents the percent change from
the estimated CY 2021 payment after applying the GAF wage adjustment to
the estimated CY 2021 payment after applying the 5-hour payment rate
(prior to removing statutorily excluded drugs and biologicals).
Overall, we estimate a 4.3 percent decrease ($3 million) in payments to
home infusion therapy suppliers in CY 2021.
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E. Alternatives Considered
1. HH PPS
    For CY 2020, we did not consider alternatives to changing the unit
of payment from 60 days to 30 days, eliminating the use of therapy
thresholds for the case-mix adjustment, and requiring the revised
payments to be budget neutral as the BBA of 2018 requires these changes
to be implemented on January 1, 2020. Section 51001 of the BBA of 2018
requires the change in the unit of payment from 60 days to 30 days to
be made in a budget neutral manner and mandates the elimination of the
use of therapy thresholds for case-mix adjustment purposes. The BBA of
2018 also requires that we make assumptions about behavior changes that
could occur as a result of the implementation of the 30-day unit of
payment and as a result of the case-mix adjustment factors that are
implemented in CY 2020 in calculating a 30-day payment amount for CY
2020 in a budget neutral manner.
    We did consider alternatives to complete RAP elimination by CY
2021. Specifically, considered a RAP phase-out over 2 years instead of
the proposed 1 year (that is, complete elimination of RAPs by CY 2022)
because we believed that additional time would be needed for HHAs to
appropriately align their systems with the new policy. However, we
chose to propose this change in CY 2020 due to imminent program
integrity concerns that have shown increasing amounts of fraudulent
activity due to the current RAP policy. We also considered different
time frames for the submission of the NOA, including a 7 day timeframe
in which to submit a timely-filed NOA. However, to be consistent with
similar requirements in other settings (for example, hospice where the
NOE must be submitted within 5 calendar days), we believe the 5 day
timely-filing requirement would
[[Page 34710]]
ensure that the Medicare claims processing system is alerted to
mitigate any overpayments for services that should be covered under the
home health benefit.
2. HHVBP
    With regard to our proposal to publicly report on the CMS website
the CY 2020 (PY 5) Total Performance Score (TPS) and the percentile
ranking of the TPS for each competing HHA that qualifies for a payment
adjustment in CY 2020, we also considered not making this Model
performance data public, and whether there was any potential cost to
stakeholders and beneficiaries if the data were to be misinterpreted.
However, we believe that providing definitions for the HHVBP TPS and
the TPS Percentile Ranking methodology would address any such concerns
by ensuring the public understands the relevance of these data points
and how they were calculated. We also considered the financial costs
associated with our proposal to publicly report HHVBP data, but do not
anticipate such costs to CMS, stakeholders or beneficiaries, as CMS
already calculates and reports the TPS and TPS Percentile Ranking in
the Annual Reports to HHAs. As discussed in section IV. of this
proposed rule, we believe the public reporting of such data would
further enhance quality reporting under the Model by encouraging
participating HHAs to provide better quality of care through focusing
on quality improvement efforts that could potentially improve their
TPS. In addition, we believe that publicly reporting performance data
that indicates overall performance may assist beneficiaries,
physicians, discharge planners, and other referral sources in choosing
higher-performing HHAs within the nine Model states and allow for more
meaningful and objective comparisons among HHAs on their level of
quality relative to their peers.
3. HH QRP
    We believe that removing the Pain Interfering with Activity Measure
(NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP would
reduce negative unintended consequences. We are proposing the removal
of the measure under Meaningful Measures Initiative measure removal
Factor 7: Collection or public reporting of a measure leads to negative
unintended consequences other than patient harm. We considered
alternatives to this measure and no appropriate alternative measure is
ready at this time. Out of an abundance of caution to potential harm
from over-prescription of opioid medications inadvertently driven by
this measure, we have determined that removing the current pain measure
is the most appropriate proposal.
    The proposed adoption of two transfer of health information process
measures is vital to satisfying section 1899B(c)(1)(E)(ii) of the Act,
which requires that the quality measures specified by the Secretary
include measures with respect to the quality measure domain of
accurately communicating the existence of and providing for the
transfer of health information and care preferences of an individual
when the individual transitions from a PAC provider to another
applicable setting. We believe adopting these measures best addresses
the requirements of the IMPACT Act for this domain. We considered not
adopting these proposals and doing additional analyses for a future
implementation. This approach was not viewed as a viable alternative
because of the extensive effort invested in creating the best measures
possible and failure to adopt measures in the domain of transfer of
health information puts CMS at risk of not meeting the legislative
mandate of the IMPACT Act.
    Collecting and reporting standardized patient assessment data under
the HH QRP is required under section 1899B(b)(1) of the Act. We have
carefully considered assessment items for each of the categories of
assessment data and believe these proposals best address the
requirements of the Act for the HH QRP. The proposed SPADEs are items
that received additional national testing after they were proposed in
the CY 2018 HH PPS proposed rule (82 FR 35354 through 35371) and more
extensively vetted. These items have been carefully considered and the
alternative of not proposing to adopt standardized patient assessment
data will result in CMS not meeting our legislative mandate under the
IMPACT Act.
4. Home Infusion Therapy
a. Home Infusion Therapy Services Temporary Transitional Payment
    We did not consider alternatives to updating the home infusion
therapy services temporary transitional payment rates for CY 2020
because section 1834(u)(7)(D) of the Act requires the Secretary to pay
eligible home infusion suppliers for home infusion therapy services at
amounts equal to the amounts determined under the physician fee
schedule for services furnished during the year for codes and units of
such codes with respect to drugs included in payment categories as
outlined in section 1834(u)(7)(C) of the Act, determined without
application of the geographic wage adjustment.
b. Home Infusion Therapy Services Payment for CY 2021 and Subsequent
Years
    We did not consider alternatives to proposing the home infusion
therapy services payment system for CY 2021 in the CY 2020 HH PPS
proposed rule, given that qualified home infusion therapy suppliers
would need ample time to understand and implement the payment policies
and billing procedures related to the new payment system.
    For the CY 2020 HH PPS proposed rule, we did consider three
alternatives to the payment proposals articulated in section VI.D. of
this proposed rule. We considered proposing a payment methodology that
maintains the three payment categories and PFS codes; but that pays per
amount and per unit for the current PFS infusion codes, up to 5 hours,
meaning we would not set the payment amount to a base amount of 5 hours
of infusion. We would utilize two existing home infusion codes for
billing, which would then correspond with the PFS code amounts per
hour. Suppliers would bill code 99601 (Home infusion/specialty drug
administration, per visit (up to 2 hours)), which would correspond to
the first 2 hours of the visit, after which suppliers would bill code
99602 (Home infusion/specialty drug administration, per visit (up to 2
hours); each additional hour), up to 3 hours. We would set the minimum
payment amount equal to 2 hours of infusion in a physician's office;
however, in analyzing CY 2018 physician office (carrier) claims we
found that the time required for most infusion services is about an
hour. Only 25 to 30 percent of the time, physicians billed for 2 hours
of care and the service almost never extended to exceed 2 hours.
Nonetheless, we did not propose this option in order to ensure that
suppliers are paid appropriately for services provided outside of an
infusion drug administration calendar day, and that patients are
assured the full scope of services under the home infusion therapy
services benefit, which includes remote monitoring.
    We also considered proposing to carry forward the payment
methodology as outlined in section 50401 of the BBA of 2018, using the
current payment categories and PFS infusion code amounts and units for
such codes, and setting payment equal to 4 hours of infusion in the
physician's office. This methodology would be consistent with the
current payment methodology for the temporary transitional payment, and
[[Page 34711]]
would not require significant changes in billing procedures.
Additionally, the three payment categories would reflect therapy type
and complexity of drug administration, as required under section
1834(u)(1)(B) of the Act. This payment methodology is similar to the
proposed payment rates; however, setting payment equal to 5 hours of
infusion in the physician's office is more in alignment with the
language at section 1834(u)(1)(A)(iii) of the Act, which sets the
maximum payment amount at 5 hours of infusion for a particular therapy
in a calendar day for CY 2021, rather than 4 hours.
    And finally, we considered a third alternative which utilizes the
5-hour payment amount, but without the increased payment for the first
visit. This option does not recognize the additional time and resources
spent during the very first home infusion therapy visit. Increasing the
payment rate for the first visit more adequately compensates for the
potential increase in visit length as compared to subsequent visits.
    Additionally, we considered an alternative to the proposed required
geographic wage adjustment articulated in section V1.E. of this
proposed rule. Specifically, we considered proposing the pre-floor,
pre-reclassified hospital wage index (HWI) that we currently use to
wage-adjust payments for both home health and hospice. With the HWI
geographic areas are defined using the Core Based Statistical Areas
(CBSA) established by the Office of Management and Budget (OMB). The
wage index value that is given to a CBSA is the ratio of the area's
average hourly wage to the national average hourly wage. The payment
for a given region would be determined by applying the wage index value
to the labor portion of the single payment amount. Although the HWI is
used for other home based services, it presents operational challenges
that would make it difficult to use for geographic wage adjustment for
home infusion therapy services. These challenges include mapping zip
codes to the correct CBSA. In order to utilizing the HWI there would
need to be significant system changes to accommodate this option. We do
not believe that the benefits of using the HWI outweigh the operational
complexity of implementing this option. Also, data analysis showed that
payment rates fluctuate more and payments tend to be lower in rural
areas when using the HWI. The most negatively affected states using HWI
are North Dakota, West Virginia, Alabama, Arkansas, and Louisiana.
    In the 2019 proposed home health rule we considered using the
Geographic Price Cost Index (GPCI) as the method of wage adjustment (83
FR 32467). The GPCI measures the relative differences in costs of work,
practice expense and malpractice in 112 localities compared to the
national average. After further analysis we determined the GPCI was not
a viable option. GPCI payments are calculated by adjusting the work,
practice expense and malpractice relative value units included in the
PFS by the corresponding GPCI. The relative value units are then
converted into a dollar amount using a conversion factor. The payment
for home infusion therapy will be a single payment amount, therefore, a
single index is needed to geographically adjust the payment.
    Finally, we considered using only the practice expense (PE) GPCI to
geographically adjust the home infusion single payment amount. The PE
GPCI is designed to measure the relative cost difference in the mix of
goods and services comprising practice expenses (not including
malpractice expenses) among the PFS localities compared to the national
average of these costs. The PE GPCI comprises four component indices
(employee wages; purchased services; office rent; and equipment,
supplies, and other miscellaneous expenses). The PE GPCI comprises
costs that are similar to home infusion costs. However, we believe that
this is not the best method for geographical wage adjustment for
several reasons. First, data analysis showed that the PE GPCI is more
variable than the GAF. Also, using only the PE GPCI excludes services
furnished in Alaska from the 1.0 PE floor and they would also not
benefit from the 1.5 work GPCI floor. Finally, the PE GPCI has not been
used on its own previously for geographic wage adjustment.
    We solicit comments on the alternatives considered for this
proposed rule.
F. Accounting Statement and Tables
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 38, we have prepared an accounting statement showing
the classification of the transfers and costs associated with the CY
2020 HH PPS provisions of this rule. Table 39 shows the burden to HHA's
for submission of OASIS. Table 40 provides our best estimate of the
increase in Medicare payments to home infusion therapy suppliers for
home infusion therapy beginning in CY 2021.
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G. Regulatory Reform Analysis Under E.O. 13771
    Executive Order 13771, entitled ``Reducing Regulation and
Controlling Regulatory Costs,'' was issued on January 30, 2017 and
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.''
This proposed rule, if finalized, is considered an E.O. 13771
regulatory action. We estimate the rule generates $169.9 million in
annualized costs in 2016 dollars, discounted at 7 percent relative to
year 2016 over a perpetual time horizon. Details on the estimated costs
of this rule can be found in the preceding and subsequent analyses.
H. Conclusion
1. HH PPS for CY 2020
    In conclusion, we estimate that the net impact of the HH PPS
policies in this rule is an increase of 1.3 percent, or $250 million,
in Medicare payments to HHAs for CY 2020. The $250 million increase
reflects the effects of the CY 2020 home health payment update
percentage of 1.5 percent as required by section 53110 of the BBA of
2018 ($290 million increase), and a 0.2 percent decrease in CY 2020
payments due to the rural add-on percentages mandated by the BBA of
2018 ($40 million decrease).
2. HHVBP
    In conclusion, as noted previously for the HHVBP Model, we are
proposing to publicly report performance data for PY 5 (CY 2020) of the
Model. This proposal would not affect our analysis of the distribution
of payment adjustments for PY 5 as presented in the CY 2019 HH PPS
final rule.
    We estimate there would be no net impact (to include either a net
increase or reduction in payments) for this proposed rule in Medicare
payments to HHAs competing in the HHVBP Model. However, the overall
economic impact of the HHVBP Model is an estimated $378 million in
total savings from a reduction in unnecessary hospitalizations and SNF
usage as a result of greater quality improvements in the home health
industry over the life of the HHVBP Model.
3. HH QRP
    In conclusion, we estimate that the changes to OASIS item
collection as a result of the proposed changes to the HH QRP effective
on January 1, 2021 would result in a net additional annualized cost of
$169.9 million, discounted at 7 percent relative to year 2016, over a
perpetual time horizon beginning in CY 2021.
4. Home Infusion Therapy
a. Home Infusion Therapy Services Temporary Transitional Payment for CY
2020
    In conclusion, we estimate that the net impact of the temporary
transitional payment to eligible home infusion suppliers for items and
services associated with the furnishing of transitional home infusion
drugs may result in up to a $1 million dollar increase/decrease in
payments for CY 2020 as determined under the physician fee schedule
established under section 1848 of the Act.
b. Home Infusion Therapy Services Payment for CY 2021
    In conclusion, we estimate that the net impact of the payment for
home infusion therapy services for CY 2021 is approximately $3 million
in reduced payments to home infusion therapy suppliers.
    This analysis, together with the remainder of this preamble,
provides an initial Regulatory Flexibility Analysis.
    In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the OMB.
List of Subjects
42 CFR Part 409
    Health facilities, Medicare.
42 CFR Part 414
    Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 484
    Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
    For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as follows:
PART 409--HOSPITAL INSURANCE BENEFITS
0
1. The authority citation for part 409 continues to read as follows:
    Authority:  42 U.S.C. 1302 and 1395hh.
0
2. Section 409.43 is amended by revising paragraph (a) to read as
follows:
Sec.  409.43  Plan of care requirements.
    (a) Contents. An individualized plan of care must be established
and periodically reviewed by the certifying physician.
    (1) The HHA must be acting upon a physician plan of care that meets
the requirements of this section for HHA services to be covered.
    (2) For HHA services to be covered, the individualized plan of care
must specify the services necessary to meet the patient-specific needs
identified in the comprehensive assessment.
    (3) The plan of care must include the identification of the
responsible discipline(s) and the frequency and duration of all visits
as well as those items listed in Sec.  484.60(a) of this chapter that
establish the need for such services. All care provided must be in
accordance with the plan of care.
* * * * *
0
3. Section 409.44 is amended by revising paragraph (c)(2)(iii)(C) to
read as follows:
Sec.  409.44  Skilled services requirements.
* * * * *
    (c) * * *
    (2) * * *
    (iii) * * *
    (C) The unique clinical condition of a patient may require the
specialized skills of a qualified therapist or therapist assistant to
perform a safe and effective maintenance program required in connection
with the patient's specific illness or injury. Where the clinical
condition of the patient is such that the
[[Page 34713]]
complexity of the therapy services required--
    (1) Involve the use of complex and sophisticated therapy procedures
to be delivered by the therapist or the physical therapist assistant in
order to maintain function or to prevent or slow further deterioration
of function; or
    (2) To maintain function or to prevent or slow further
deterioration of function must be delivered by the therapist or the
physical therapist assistant in order to ensure the patient's safety
and to provide an effective maintenance program, then those reasonable
and necessary services must be covered.
* * * * *
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
4. The authority citation for part 414 continues to read as follows:
    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
0
 5. Add subpart P to read as follows:
Subpart P--Home Infusion Therapy Services Payment
Conditions for Payment
Sec.
414.1500 Basis, purpose, and scope.
414.1505 Requirement for payment.
414.1510 Beneficiary qualifications for coverage of services.
414.1515 Plan of care requirements.
Payment System
414.1550 Basis of payment.
Subpart P--Home Infusion Therapy Services Payment
Conditions for Payment
Sec.  414.1500  Basis, purpose, and scope.
    This subpart implements section 1861(iii) of the Act with respect
to the requirements that must be met for Medicare payment to be made
for home infusion services furnished to eligible beneficiaries.
Sec.  414.1505  Requirement for payment.
    In order for home infusion therapy services to qualify for payment
under the Medicare program the services must be furnished to an
eligible beneficiary by, or under arrangements with, a qualified home
infusion therapy supplier that meets following:
    (a) The health and safety standards for qualified home infusion
therapy suppliers at Sec.  486.520(a) through (c) of this chapter.
    (b) All requirements set forth in Sec. Sec.  414.1510 through
414.1550.
Sec.  414.1510  Beneficiary qualifications for coverage of services.
    To qualify for Medicare coverage of home infusion therapy services,
a beneficiary must meet each of the following requirements:
    (a) Under the care of an applicable provider. The beneficiary must
be under the care of an applicable provider, as defined in section
1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or
physician assistant.
    (b) Under a physician plan of care. The beneficiary must be under a
plan of care that meets the requirements for plans of care specified in
Sec.  414.1515.
Sec.  414.1515  Plan of care requirements.
    (a) Contents. The plan of care must contain those items listed in
Sec.  486.520(b) of this chapter that specify the standards relating to
a plan of care that a qualified home infusion therapy supplier must
meet in order to participate in the Medicare program.
    (b) Physician's orders. The physician's orders for services in the
plan of care must specify at what frequency the services will be
furnished, as well as the discipline that will furnish the ordered
professional services. Orders for care may indicate a specific range in
frequency of visits to ensure that the most appropriate level of
services is furnished.
    (c) Plan of care signature requirements. The plan of care must be
signed and dated by the ordering physician prior to submitting a claim
for payment. The ordering physician must sign and date the plan of care
upon any changes to the plan of care.
Payment System
Sec.  414.1550  Basis of payment.
    (a) General rule. For home infusion therapy services furnished on
or after January 1, 2021, Medicare payment is made on the basis of 80
percent of the lesser of the following:
    (1) The actual charge for the item.
    (2) The fee schedule amount for the item, as determined in
accordance with the provisions of this section.
    (b) Unit of single payment. A unit of single payment is made for
items and services furnished by a qualified home infusion therapy
supplier per payment category for each infusion drug administration
calendar day, as defined at Sec.  486.505 of this chapter.
    (c) Initial establishment of the payment amounts. In calculating
the initial single payment amounts for CY 2021, CMS determined such
amounts using the equivalent to 5 hours of infusion services in a
physician's office as determined by codes and units of such codes under
the annual fee schedule issued under section 1848 of the Act as
follows:
    (1) Category 1. Includes certain intravenous infusion drugs for
therapy, prophylaxis, or diagnosis, including antifungals and
antivirals; inotropic and pulmonary hypertension drugs; pain management
drugs; chelation drugs; and other intravenous drugs as added to the
durable medical equipment local coverage determination (DME LCD) for
external infusion pumps. Payment equals 1 unit of 96365 plus 4 units of
96366.
    (2) Category 2. Includes certain subcutaneous infusion drugs for
therapy or prophylaxis, including certain subcutaneous immunotherapy
infusions. Payment equals 1 unit of 96369 plus 4 units of 96370.
    (3) Category 3. (i) Includes intravenous chemotherapy infusions,
including certain chemotherapy drugs and biologicals.
    (ii) Payment equals 1 unit of 96413 plus 4 units of 96415.
    (4) Initial visit. (i) For each of the three categories listed in
paragraphs (c)(1) through (3) of this section, the payment amounts are
set higher for the first visit by the qualified home infusion therapy
supplier to initiate the furnishing of home infusion therapy services
in the patient's home and lower for subsequent visits in the patient's
home. The difference in payment amounts is a percentage based on the
relative payment for a new patient rate over an existing patient rate
using the annual physician fee schedule evaluation and management
payment amounts for a given year and calculated in a budget neutral
manner.
    (ii) The first visit payment amount is subject to the following
requirements if a patient has previously received home infusion therapy
services:
    (A) The previous home infusion therapy services claim must include
a patient status code to indicate a discharge.
    (B) If a patient has a previous claim for HIT services, the first
visit home infusion therapy services claim subsequent to the previous
claim must show a gap of more than 60 days between the last home
infusion therapy services claim and must indicate a discharge in the
previous period before a HIT supplier may submit a home infusion
therapy services claim for the first visit payment amount.
    (d) Required payment adjustments. The single payment amount
represents payment in full for all costs associated with the furnishing
of home infusion therapy services and is subject to the following
adjustments:
[[Page 34714]]
    (1) An adjustment for a geographic wage index and other costs that
may vary by region, using an appropriate wage index based on the site
of service of the beneficiary.
    (2) Beginning in 2022, an annual increase in the single payment
amounts from the prior year by the percentage increase in the Consumer
Price Index (CPI) for all urban consumers (United States city average)
for the 12-month period ending with June of the preceding year.
    (3)(i) An annual reduction in the percentage increase described in
paragraph (c)(2) of this section by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act.
    (ii) The application of the paragraph (c)(3)(i) of this section may
result in both of the following:
    (A) A percentage being less than zero for a year.
    (B) Payment being less than the payment rates for the preceding
year.
    (e) Medical review. All payments under this system may be subject
to a medical review adjustment reflecting the following:
    (1) Beneficiary eligibility.
    (2) Plan of care requirements.
    (3) Medical necessity determinations.
PART 484--HOME HEALTH SERVICES
0
6. The authority citation for part 484 continues to read as follows:
    Authority: 42 U.S.C. 1302 and 1395hh unless otherwise indicated.
0
7. Section 484.202 is amended by adding the definitions of ``HHCAHPS''
and ``HH QRP'' in alphabetical order to read as follows:
Sec.  484.202  Definitions.
* * * * *
    HHCAHPS stands for Home Health Care Consumer Assessment of
Healthcare Providers and Systems.
    HH QRP stands for Home Health Quality Reporting Program.
* * * * *
0
8. Section 484.205 is amended by--
0
a. Revising paragraph (g)(2)(i);
0
b. Removing paragraph (g)(2)(ii);
0
c. Redesignating paragraph (g)(2)(iii) as paragraph (g)(2)(ii);
0
d. Revising newly resdesignated paragraph (g)(2)(ii);
0
e. Adding paragraph (g)(3);
0
f. Revising the heading for paragraph (h); and
0
g. Adding paragraph (i).
    The revisions and additions read as follows:
Sec.  484.205  Basis of payment.
* * * * *
    (g) * * *
    (2) * * *
    (i) HHAs certified for participation in Medicare on or before
December 31, 2018. (A) The initial payment for all 30-day periods is
paid to an HHA at 20 percent of the case-mix and wage-adjusted 30-day
payment rate.
    (B) The residual final payment for all 30-day periods is paid at 80
percent of the case-mix and wage-adjusted 30-day payment rate.
    (ii) HHAs certified for participation in Medicare on or after
January 1, 2019. An HHA that is certified for participation in Medicare
effective on or after January 1, 2019 receives a single payment for a
30-day period of care after the final claim is submitted.
    (3) Payments for periods beginning on or after January 1, 2021.
HHAs receive a single payment for a 30-day period of care after the
final claim is submitted.
    (h) Requests for anticipated payment (RAP) prior to January 1,
2021. * * *
    (i) Submission of Notice of Admission (NOA)--(1) For periods of
care on and after January 1, 2021. For periods of care beginning on and
after January 1, 2021, all HHAs must submit a Notice of Admission (NOA)
when either of the following conditions are met:
    (i)(A) The plan of care has been signed by the certifying
physician.
    (B) If the physician-signed plan of care is not available at the
time of submission of the NOA, then the submission must be based on
either of the following:
    (1) A physician's verbal order that--
    (i) Is recorded in the plan of care;
    (ii) Includes a description of the patient's condition and the
services to be provided by the home health agency;
    (iii) Includes an attestation (relating to the physician's orders
and the date received) signed and dated by the registered nurse or
qualified therapist (as defined in Sec.  484.115) responsible for
furnishing or supervising the ordered service in the plan of care; and
    (iv) Is copied into the plan of care and the plan of care is
immediately submitted to the physician.
    (2) A referral prescribing detailed orders for the services to be
rendered that is signed and dated by a physician.
    (ii) [Reserved]
    (2) Consequences of failure to submit a timely Notice of Admission.
When a home health agency does not file the required NOA for its
Medicare patients within 5 calendar days after the start of care--
    (i) Medicare does not pay for those days of home health services
from the start date to the date of filing of the notice of admission;
    (ii) The wage-adjusted 30-day period payment amount is reduced by
1/30th for each day from the home health start of care date until the
date the HHA submits the NOA;
    (iii) No LUPA payments are made that fall within the late NOA
period;
    (iv) The payment reduction cannot exceed the total payment of the
claim.
    (v)(A) The non-covered days are a provider liability; and
    (B) The provider must not bill the beneficiary for the noncovered
days.
    (3) Exception to the consequences for filing the NOA late. (i) CMS
may waive the consequences of failure to submit a timely-filed NOA
specified in paragraph (i)(2) of this section.
    (ii) CMS determines if a circumstance encountered by a home health
agency is exceptional and qualifies for waiver of the consequence
specified in paragraph (i)(2) of this section.
    (iii) A home health agency must fully document and furnish any
requested documentation to CMS for a determination of exception. An
exceptional circumstance may be due to, but is not limited to the
following:
    (A) Fires, floods, earthquakes, or similar unusual events that
inflict extensive damage to the home health agency's ability to
operate.
    (B) A CMS or Medicare contractor systems issue that is beyond the
control of the home health agency.
    (C) A newly Medicare-certified home health agency that is notified
of that certification after the Medicare certification date, or which
is awaiting its user ID from its Medicare contractor.
    (D) Other situations determined by CMS to be beyond the control of
the home health agency.
Sec.  484.225  [Amended]
0
9. Section 484.225 is amended by--
0
a. Removing paragraph (b).
0
b. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
0
c. In newly redesignated paragraph (c), removing the phrase
``paragraphs (a) through (c) of this section'' and adding in its place
the phrase ``paragraphs (a) and (b) of this section''.
0
10. Add Sec.  484.245 to read as follows:
Sec.  484.245  Requirements under the Home Health Quality Reporting
Program (HH QRP).
    (a) Participation. Beginning January 1, 2007, an HHA must report
Home Health Quality Reporting Program (HH QRP) data in accordance with
the requirements of this section.
    (b) Data submission. (1) Except as provided in paragraph (d) of
this section, and for a program year, a HHA must submit all of the
following to CMS:
    (i) Data on measures specified under sections 1899B(c)(1) and
1899B(d)(1) of the Act.
[[Page 34715]]
    (ii) Standardized patient assessment data required under section
1899B(b)(1) of the Act.
    (iii) Quality data required under section 1895(b)(3)(B)(v)(II) of
the Act, including HHCAHPS survey data. For purposes of HHCAHPS survey
data submission, the following additional requirements apply:
    (A) Patient count. An HHA that has less than 60 eligible unique
HHCAHPS patients must annually submit their total HHCAHPS patient count
to CMS to be exempt from the HHCAHPS reporting requirements for a
calendar year.
    (B) Survey requirements. An HHA must contract with an approved,
independent HHCAHPS survey vendor to administer the HHCAHPS on its
behalf.
    (C) CMS approval. CMS approves an HHCAHPS survey vendor if the
applicant has been in business for a minimum of 3 years and has
conducted surveys of individuals and samples for at least 2 years.
    (1) For HHCAHPS, a ``survey of individuals'' is defined as the
collection of data from at least 600 individuals selected by
statistical sampling methods and the data collected are used for
statistical purposes.
    (2) All applicants that meet these requirements will be approved by
CMS.
    (D) Disapproval by CMS. No organization, firm, or business that
owns, operates, or provides staffing for a HHA is permitted to
administer its own HHCAHPS survey or administer the survey on behalf of
any other HHA in the capacity as an HHCAHPS survey vendor. Such
organizations will not be approved by CMS as HHCAHPS survey vendors.
    (E) Compliance with oversight activities. Approved HHCAHPS survey
vendors must fully comply with all HHCAHPS oversight activities,
including allowing CMS and its HHCAHPS program team to perform site
visits at the vendors' company locations.
    (2) The data submitted under paragraphs (b)(1)(i) through (iii) of
this section must be submitted in the form and manner, and at a time,
specified by CMS.
    (c) Exceptions and extension requirements. (1) A HHA may request
and CMS may grant exceptions or extensions to the reporting
requirements under paragraph (b) of this section for one or more
quarters, when there are certain extraordinary circumstances beyond the
control of the HHA.
    (2) A HHA may request an exception or extension within 90 days of
the date that the extraordinary circumstances occurred by sending an
email to CMS Home Health Annual Payment Update (HHAPU) reconsiderations
at [email protected] that contains all of the following
information:
    (i) HHA CMS Certification Number (CCN).
    (ii) HHAs Business Name.
    (iii) HHA Business Address.
    (iv) CEO or CEO-designated personnel contact information including
name, title, telephone number, email address, and mailing address (the
address must be a physical address, not a post office box).
    (v) HHA's reason for requesting the exception or extension.
    (vi) Evidence of the impact of extraordinary circumstances,
including, but not limited to, photographs, newspaper, and other media
articles.
    (vii) Date when the HHA believes it will be able to again submit
data under paragraph (b) of this section and a justification for the
proposed date.
    (3) Except as provided in paragraph (c)(4) of this section, CMS
does not consider an exception or extension request unless the HHA
requesting such exception or extension has complied fully with the
requirements in this paragraph (c).
    (4) CMS may grant exceptions or extensions to HHAs without a
request if it determines that one or more of the following has
occurred:
    (i) An extraordinary circumstance, such as an act of nature,
affects an entire region or locale.
    (ii) A systemic problem with one of CMS's data collection systems
directly affects the ability of a HHA to submit data under paragraph
(b) of this section.
    (d) Reconsiderations. (1)(i) HHAs that do not meet the quality
reporting requirements under this section for a program year will
receive a letter of noncompliance via the United States Postal Service
and notification in the Certification and Survey Provider Enhanced
Report (CASPER) system.
    (ii) An HHA may request reconsideration no later than 30 calendar
days after the date identified on the letter of non-compliance.
    (2) Reconsideration requests may be submitted to CMS by sending an
email to CMS HHAPU reconsiderations at
[email protected] containing all of the following
information:
    (i) HHA CCN.
    (ii) HHA Business Name.
    (iii) HHA Business Address.
    (iv) CEO or CEO-designated personnel contact information including
name, title, telephone number, email address, and mailing address (the
address must be a physical address, not a post office box).
    (v) CMS identified reason(s) for non-compliance from the non-
compliance letter.
    (vi) Reason(s) for requesting reconsideration, including all
supporting documentation.
    (3) CMS will not consider a reconsideration request unless the HHA
has complied fully with the submission requirements in paragraph (d)(2)
of this section.
    (4) CMS will make a decision on the request for reconsideration and
provide notice of the decision to the HHA through CASPER and via letter
sent via the United States Postal Service.
    (e) Appeals. An HHA that is dissatisfied with CMS' decision on a
request for reconsideration submitted under paragraph (d) of this
section may file an appeal with the Provider Reimbursement Review Board
(PRRB) under 42 CFR part 405, subpart R.
0
11. Section 484.250 is revised to read as follows:
Sec.  484.250  OASIS data.
    An HHA must submit to CMS the OASIS data described at Sec.
484.55(b) and (d) as is necessary for CMS to administer the payment
rate methodologies described in Sec. Sec.  484.215, 484.220, 484.230,
484.235, and 484.240.
0
12. Section 484.315 is amended by revising the section heading and
adding paragraph (d) to read as follows:
Sec.  484.315  Data reporting for measures and evaluation and the
public reporting of model data under the Home Health Value-Based
Purchasing (HHVBP) Model.
* * * * *
    (d) For performance year 5, CMS publicly reports the following for
each competing home health agency on the CMS website:
    (1) The Total Performance Score.
    (2) The percentile ranking of the Total Performance Score.
    Dated: June 14, 2019.
Seema Verma,
 Administrator, Centers for Medicare and Medicaid Services.
    Dated: June 20, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-14913 Filed 7-11-19; 4:15 pm]
BILLING CODE 4120-01-P