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, 60478-60646 [2019-24026]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 84, Number 217 (Friday, November 8, 2019)]
[Rules and Regulations]
[Pages 60478-60646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24026]



[[Page 60477]]

Vol. 84

Friday,

No. 217

November 8, 2019

Part II





 Department of Health and Human Services





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 Centers for Medicare & Medicaid Services





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42 CFR Parts 409, 414, 484, et al.





 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; Final Rule

Federal Register / Vol. 84 , No. 217 / Friday, November 8, 2019 / 
Rules and Regulations

[[Page 60478]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 414, 484, and 486

[CMS-1711-FC]
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: Final rule with comment period.

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SUMMARY: This final rule with comment period updates the home health 
prospective payment system (HH PPS) payment rates and wage index for CY 
2020; implements the Patient-Driven Groupings Model (PDGM), a revised 
case-mix adjustment methodology, for home health services beginning on 
or after January 1, 2020. This final rule with comment period 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 finalizes a 30-day payment amount for CY 2020. 
Additionally, this final rule with comment period: Modifies the payment 
regulations pertaining to the content of the home health plan of care; 
allows therapist assistants to furnish maintenance therapy; and changes 
the split percentage payment approach under the HH PPS. For the Home 
Health Value-Based Purchasing (HHVBP) model, we are finalizing 
provisions requiring the public reporting of 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. This final rule with comment period also finalizes the 
following updates to the Home Health Quality Reporting Program (HH 
QRP): Removal of a measure; adoption of two new measures; modification 
of an existing measure; and a requirement for HHA's to report 
standardized patient assessment data beginning with the CY 2022 HH QRP. 
Additionally, we are finalizing our proposal to re-designate our 
current HH QRP regulations in a different section of our regulations 
and to codify other current policies in that new regulatory section 
with one substantive change as well as a few technical edits. We are 
not finalizing our proposal to remove question 10 from all of the HH 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
surveys. Lastly, it sets forth routine updates to the home infusion 
therapy payment rates for CY 2020, payment provisions for home infusion 
therapy services for CY 2021 and subsequent years, and solicits 
comments on options to enhance future efforts to improve policies 
related to coverage of eligible drugs for home infusion therapy.

DATES: Effective Date: This final rule with comment period is effective 
January 1, 2020.
    Comment Date: To be assured consideration, comments on the criteria 
that can be considered to allow coverage of additional drugs under the 
DME benefit discussed in section VI.D. of this final rule with comment 
period must be received at one of the addresses provided below, no 
later than 5 p.m. on December 30, 2019.

ADDRESSES: In commenting, please refer to file code CMS-1711-FC. 
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 https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1711-FC, 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-FC, 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: Hillary Loeffler, (410) 786-0456, 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: https://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. 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. CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes of Care 
Spanning Implementation of the PDGM
    D. CY 2020 PDGM Case-Mix Weights and Low-Utilization Payment 
Adjustment (LUPA) Thresholds
    E. CY 2020 Home Health Payment Rate Updates
    F. Payments for High-Cost Outliers under the HH PPS
    G. Changes to the Split-Percentage Payment Approach for HHAs in 
CY 2020 and Subsequent Years
    H. Change To Allow Therapist Assistants To Perform Maintenance 
Therapy

[[Page 60479]]

    I. Changes to the Home Health Plan of Care Regulations at Sec.  
409.43
IV. Home Health Value-Based Purchasing (HHVBP) Model
    A. Background
    B. Public Reporting of Total Performance Scores and Percentile 
Rankings Under the HHVBP Model
    C. Removal of Improvement in Pain Interfering With Activity 
Measure (NQF #0177)
V. Home Health Quality Reporting Program (HH QRP)
    A. Background and Statutory Authority
    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 Removal of HH QRP Measures Beginning With the CY 2022 HH QRP
    E. 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. Standardized Patient Assessment Data Reporting Beginning With 
the CY 2022 HH QRP
    H. Standardized Patient Assessment Data by Category
    I. Form, Manner, and Timing of Data Submission Under the HH QRP
    J. 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. Home Infusion Therapy Services for CY 2021 and Subsequent 
Years
    D. 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. Waiver of Proposed Rule
VIII. Collection of Information Requirements
IX. 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 final rule with comment period updates 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 rule 
also updates 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 final rule with comment period implements the 
PDGM, a revised case-mix adjustment methodology that was finalized in 
the CY 2019 HH PPS final rule with comment period (83 FR 56406), which 
also implements 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 final rule with comment period allows 
therapist assistants to furnish maintenance therapy; finalizes changes 
to the payment regulations pertaining to the content of the home health 
plan of care; updates technical regulations text changes which 
clarifies the split-percentage payment approach for newly-enrolled HHAs 
in CY 2020 and changes the split percentage payment approach for 
existing HHAs in CY 2020 and subsequent years.
2. HHVBP
    This final rule with comment period finalizes public reporting of 
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 HHA that qualifies for a payment adjustment under the 
HHVBP Model for CY 2020.
3. HH QRP
    This final rule with comment period finalizes 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 final rule with comment period finalizes payment provisions 
for home infusion therapy services for CY 2021 and subsequent years in 
accordance with section 1834(u) 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 final rule with comment period sets forth 
the 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 final rule with 
comment period 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 1895(b)(3) of the Act requires that we calculate this 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. The CY 2020 30-day payment amount (for 
those HHAs that report the required quality data) will be $1,864.03, 
which reflects an adjustment of -4.36 percent to maintain overall 
budget neutrality under the PDGM.
    Section III.C. of this final rule with comment period 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 rule 
finalizes the CY 2020 PDGM case-mix weights and LUPA thresholds for 30-
day periods of care. In section III.E. of this final rule, we finalize 
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, 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 is 1.5 percent, as 
required by section 53110 of the BBA of 2018. Section III.F. of this 
final rule with comment period, finalizes changes change to the fixed-
dollar loss ratio to

[[Page 60480]]

0.56 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 final rule with comment period, finalized 
technical regulations correction at Sec.  484.205 regarding split-
percentage payments for newly-enrolled HHAs in CY 2020; and finalizes 
the following additional changes to the split-percentage payment 
approach: (1) A reduction in the up-front amount paid in response to a 
Request for Anticipated Payment (RAP) to 20 percent of the estimated 
final payment amount for both initial and subsequent 30-day periods of 
care for CY 2020; (2) a reduction to the up-front amount paid in 
response to a RAP to zero percent of the estimated final payment amount 
for both initial and subsequent 30-day periods of care with a late 
submission penalty for failure to submit the RAP within 5 calendar days 
of the start of care for the first 30-day period within a 60-day 
certification period and within 5 calendar days of day 31 for the 
second, subsequent 30-day period in a 60-day certification period for 
CY 2021; (3) the elimination of the split-percentage payment approach 
entirely in CY 2022, replacing the RAP with a one-time submission of a 
Notice of Admission (NOA) with a late submission penalty for failure to 
submit the NOA within 5 calendar days of the start of care. In section 
III.H. of this final rule with comment period, we are finalizing our 
proposal to allow therapist assistants to furnish maintenance therapy 
under the Medicare home health benefit, and section III.I. of this 
final rule with comment period, we finalize a change in the payment 
regulation text at Sec.  409.43 related to home health plan of care 
requirements for payment.
2. HHVBP
    In section IV. of this final rule with comment period, we are 
finalizing provisions requiring public reporting performance data for 
Performance Year (PY) 5 of the HHVBP Model. Specifically, we are 
finalizing the public reporting of 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 final rule with comment period, we are 
finalizing 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 a 
requirement for HHAs to report standardized patient assessment data. In 
section V.J. of this final rule, we are finalizing our proposal to re-
designate our current HH QRP regulations in a different section of our 
regulations and to codify other current policies in that new regulatory 
section with one substantive change as well as a few technical edits. 
Finally, in section V.K. of the rule, we are not finalizing the removal 
of question 10 from all HHCAHPS Surveys (both mail surveys and 
telephone surveys).
4. Home Infusion Therapy
    In section VI.A. of this final rule with comment period, we discuss 
the general background of home infusion therapy services and how that 
relates to the implementation of the new home infusion benefit in CY 
2021. Section VI.B. of this final rule with comment period discusses 
the updates to 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 final rule with comment period, we 
are finalizing our proposal 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. Subpart P includes 
beneficiary qualifications and plan of care requirements in accordance 
with section 1861(iii) of the Act. In section VI.D. of this final rule 
with comment period, we finalize 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 
payment categories, amounts, and required and optional payment 
adjustments. In section VI.E. of this final rule with comment period, 
we finalize the use of 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 section VI.F. of this final rule with 
comment period, we summarize comments received on the proposed rule 
regarding several topics for home infusion therapy services for CY 2021 
such as: Optional payment adjustments, prior authorization, and high-
cost outliers. In section VI.G. of this final rule with comment period, 
we discuss billing procedures for CY 2021 home infusion therapy 
services. Lastly, given the new permanent home infusion therapy benefit 
to be implemented beginning January 1, 2021, which includes payment for 
professional services, including nursing, for parenteral drugs 
administered intravenously or subcutaneously for a period of 15 minutes 
or more through a pump that is a covered item of DME; we are soliciting 
comments on options to enhance future efforts to improve policies 
related to coverage of eligible drugs for home infusion therapy. In 
response to stakeholder concerns regarding the limitations of the DME 
LCDs for External Infusion Pumps that preclude coverage to certain 
infused drugs, we seek comments on the criteria CMS could consider, 
within the scope of the DME benefit, to allow coverage of additional 
home infusion drugs.

C. Summary of Costs, Transfers, and Benefits

BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR08NO19.000

BILLING CODE 4120-01-C

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 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

[[Page 60482]]

to be adjusted for case-mix and geographic differences in wage levels. 
Section 1895(b)(4)(B) of the Act requires 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 and these changes are discussed later in this final rule 
with comment period.

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 with comment period (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

[[Page 60483]]

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 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 with comment 
period, 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. 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 with comment period (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 (84 FR 34602), we examined FY 2017 HHA 
cost reports as this is the most recent and complete cost report data 
at the time of rulemaking. We include this analysis again in this final 
rule with comment period. 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.
[GRAPHIC] [TIFF OMITTED] TR08NO19.001

    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. In the 
proposed rule, we estimated the CY 2020 costs by using the home health 
market basket update of 1.5 percent as required by the BBA of 2018. 
However, for this final rule with comment period, we believe that we 
should be consistent with the estimation of cost calculations for 
purposes of analyzing the payment adequacy. This would warrant the same 
approach for estimating CY 2020 costs as was used for CYs 2018 and 
2019. Therefore, for this final rule with comment period, we calculated 
the estimated CY 2020 60-day episode costs and 30-day period costs by 
applying each year's market basket update minus the multifactor 
productivity factor for that year. For CY 2020, based on IHS Global 
Inc. 2019 q3 forecast, the home health market basket update is 
forecasted to be 2.9 percent; the MFP adjustment is forecasted to be 
0.3 percent resulting in a forecasted MFP-adjusted home health market 
basket update of 2.6 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.

[[Page 60484]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.002

    The CY 2020 60-day episode payment will be $3,220.79, approximately 
16 percent more than the estimated CY 2020 60-day episode cost of 
$2,767.15.
    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] TR08NO19.003

    Using the same approach as calculating the estimated CY 2020 60-day 
episode costs, 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 2019, and 2020. 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.

[[Page 60485]]

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    The estimated, budget-neutral 30-day payment for CY 2020 is, 
$1,824.99 as described in section III.E. of this final rule with 
comment period. Updating this amount by the CY 2020 home health market 
basket update of 1.5 percent and the wage index budget neutrality 
factor results in an estimated CY 2020 30-day payment amount of 
$1,864.03 (as described in section III.B. of this final rule with 
comment period) approximately 16 percent more than the estimated CY 
2020 30-day period cost of $1,608.82. 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. 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 with comment period (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.
    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 
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 finalized these behavior assumptions in the CY 2019 HH 
PPS final rule with comment period (83 FR 56461) and these assumptions 
are further described in section III.B. of this final rule with comment 
period.
    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.

[[Page 60486]]

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 with comment period 
(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 final rule with comment period effectuates the 
requirements for the implementation of the PDGM, as well as finalizes 
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 with comment 
period (83 FR 56406) and, as such, there were no new policy proposals 
in the CY 2020 home health proposed rule on the structure of the PDGM 
or the change to a 30-day unit of payment. However, there were 
proposals related to the split-percentage payments upon implementation 
of the PDGM and the 30-day unit of payment as described in section 
III.G. of this final rule with comment period.
    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.E. of this final 
rule with comment period, will 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 Figure 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 
final rule with comment period (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 final CY 2020 
PDGM case-mix weights are listed in section III.D. of this final rule 
with comment period.
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[[Page 60487]]

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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 re-certifications 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.
    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

[[Page 60488]]

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\ has 
been updated to reflect all of the claims processing changes associated 
with implementation of the PDGM.
---------------------------------------------------------------------------

    \1\ Home Health (HH) Patient-Driven Groupings Model (PDGM)--
Split Implementation Change Request. February 15, 2019. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4244CP.pdf.
    \2\ Medicare Claims Processing Manual Chapter 10--Home Health 
Agency Billing. 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 60489]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.006

    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 \3\ 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.\4\ 
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.
---------------------------------------------------------------------------

    \3\ Home Health Agency (HHA) Interpretive Guidelines. August 31, 
2018. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-25-HHA.pdf.
    \4\ 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.\5\ 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.
---------------------------------------------------------------------------

    \5\ Outcome and Assessment Information Set OASIS-D Guidance 
Manual. January 1, 2019. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-D-Guidance-Manual-final.pdf.
---------------------------------------------------------------------------

    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,\6\ interpretive guidelines, and the OASIS D Guidance 
Manual instructions, as previously noted.
---------------------------------------------------------------------------

    \6\ Home Health Conditions of Participation. https://www.ecfr.gov/cgi-bin/text-idx?SID=fb4353988ab209999ca866efc142a601&mc=true&node=pt42.5.484&rgn=div5.
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    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

[[Page 60490]]

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 is included in the Medicare Claims 
Processing Manual, chapter 10.
    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, to accompany this final rule with comment period, we 
updated 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 PDGM web page (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html). This 
Interactive Grouper Tool includes all of the ICD-10-CM 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. This Interactive Grouper Tool has been 
provided to assist HHAs in understanding the effects of the transition 
to the PDGM and will not be updated on an annual basis after CY 2020 as 
HHAs will have the opportunity download the HH PPS Grouper annually. 
The final grouper for CY 2020 will be posted with this final rule with 
comment period and can be found on the following website: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware.html. Additionally, HHAs can also request a Home 
Health Claims-OASIS Limited Data Set (LDS) to accompany the CY 2020 HH 
PPS final rule with comment period 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 CMS Limited Data Set 
(LDS) Files 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] TR08NO19.007

    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.\7\ 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 8 and 9 
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 with comment period (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 this CY 2020 HH 
PPS final rule with comment period, we updated 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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    \7\ Overview of the Home Health Groupings Model. November 18, 
2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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[[Page 60493]]

    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 
finalized CY 2020 functional points table and the functional impairment 
level thresholds table are posted on the HHA Center web page as well as 
on the PDGM web page.
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 are reported in more than 
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.
    For CY 2020, there are 13 low comorbidity adjustment subgroups as 
identified in Table 10 and 31 high comorbidity adjustment interaction 
subgroups as identified in Table 11.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C

[[Page 60495]]

    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 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 finalized CY 2020 low 
comorbidity adjustment subgroups and the high comorbidity adjustment 
interaction subgroups including those diagnoses within each of these 
comorbidity adjustments are posted on the HHA Center web page as well 
as on the PDGM web page.
    While we did not solicit comments on the PDGM as it was finalized 
in the CY 2019 HH PPS final rule with comment period (83 FR 56406), we 
did receive 179 comments on various components of the finalized PDGM 
from home health agencies, industry associations, as well as 
individuals. We received a few general comments on the PDGM as a whole. 
A few comments were received on the admission source case-mix variable, 
elimination of therapy thresholds, and the comorbidity adjustment; 
however, the majority of these comments were specific ICD 10-CM code 
requests to include certain previously excluded diagnosis codes as part 
of the clinical grouping variable or to move specific diagnosis codes 
from one clinical group to another. These comments and our responses 
are summarized in this section of this final rule with comment period.
1. General PDGM Comments
    Comment: Several commenters stated they are very encouraged by 
CMS's efforts to develop a valid and reliable case mix adjustment model 
that relies on patient characteristics rather than resource use to 
determine the amount of payment in individual service claims. However, 
these commenters expressed concern that the PDGM could create financial 
incentives for home health agencies to under-supply needed care through 
inappropriate early discharge, improperly limiting the number of visits 
or types of services provided, or discouraging serving individuals with 
longer-term needs and people without a prior institutional stay. A 
commenter recommended that CMS monitor these issues and quality of care 
during initial implementation of the PDGM in ways that will allow CMS 
to quickly understand and address emerging problems affecting the 
provision of home health services. This commenter also suggested that 
CMS educate home health agencies as well as beneficiaries and their 
family caregivers about the need for beneficiaries to receive high-
quality home health care that meets each Medicare beneficiary's unique 
needs. Other suggestions included requiring agencies to provide clear, 
accurate information about what Medicare covers and beneficiary appeal 
rights and updating CMS educational materials for beneficiaries to 
assist in this effort. Another commenter urged CMS to be transparent 
about its education budget and include information about the different 
mechanisms it will use for the education of providers, beneficiaries, 
and their family caregivers (as appropriate).
    Response: We appreciate commenter support of a case-mix system 
based on patient-characteristics and other clinical information, rather 
than one based on the volume of services provided. We agree that this 
is a more accurate way to align payment with the cost of providing 
care. However, we recognize stakeholder concerns about possible 
perverse financial incentives that could arise as a result of 
transitioning to a new case-mix adjustment methodology and a change in 
the unit of payment. We reiterate that we expect the provision of 
services to be made to best meet the patient's care needs and in 
accordance with the home health CoPs at Sec.  484.60 which sets forth 
the requirements for the content of the individualized home health plan 
of care which includes the types of services, supplies, and equipment 
required; the frequency and duration of visits to be made; as well as 
patient and caregiver education and training to facilitate timely 
discharge. Therefore, we do not expect HHAs to under-supply care or 
services; reduce the number of visits in response to payment; or 
inappropriately discharge a patient receiving Medicare home health 
services as these would be violations of the CoPs and could also 
subject HHAs to program integrity measures.
    We also note that the home health CoPs at Sec.  484.50(c) set forth 
patient rights, which include the patient's right to be involved in the 
plan of care, the right to be informed of any changes to the plan of 
care, as well as expected coverage, and possible beneficiary financial 
liability. Therefore, HHAs are already tasked with informing 
beneficiaries as to their rights and coverage under the Medicare home 
health benefit. Moreover, CMS does routinely update its public 
materials to ensure relevant stakeholders are informed of any policy, 
coverage, or payment changes. This includes updates to the Medicare 
Benefit Policy Manual, the ``Medicare and You'' Handbook, ``Medicare's 
Home Health Benefit'' booklet, and MLN Matters[supreg] articles on 
various aspects of the home health benefit. As with any policy, 
coverage, or payment change, we will update the necessary public 
information to ensure full transparency and to provide ample resources 
for beneficiaries and their families, as well as for home health 
agencies. The goal of the PDGM is to more accurately align home health 
payment with patient needs. We note that each individual policy change 
does not have a corresponding individual educational budget connected 
with its implementation; therefore this is not information we can 
provide. We acknowledge that the change to a new case-mix system may 
have unintended consequences through shifts in home health practices. 
However, in the CY 2020 HH PPS proposed rule, we stated that we expect 
the provision of services to be made to best meet the patient's care 
needs and in accordance with existing regulations. 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.
    Comment: A commenter stated that under the current HH PPS, HHAs' 
costs are ``frontloaded'' and incurred regardless of whether a second 
30-day period occurs within a 60-day episode. This commenter stated 
that CMS should account for these costs and allocate payment weights 
more toward the first 30-day period in each 60-day episode to ensure 
that payments are accurately aligned with resource use. Commenters 
express several concerns with the use of cost report data rather than 
Bureau of Labor Statistics (BLS) wage data to account for the cost of 
therapy services; thus, commenters recommend CMS use BLS wage-weighted 
minutes instead of the approach finalized in the CY 2019 final rule 
with comment period.
    Response: We note that we provided detailed analysis on the 
estimated costs of 30-day periods of care using a cost-per-minute plus 
non-routine supply (CPM + NRS) approach in the CY 2019 HH PPS proposed 
rule (83 FR 32387). We also provided analysis on the average resource 
use by timing where early 30-day periods have higher resource use that 
later 30-day periods (83 FR 32392). Likewise, in the CY 2019

[[Page 60496]]

HH PPS final rule with comment period (83 FR 56471), we finalized the 
admission source case-mix variable under the PDGM where ``early'' 30-
day periods of care receive a higher payment than ``late'' 30-day 
periods of care. Commenters supported this payment differential as it 
more accurately reflects HHA costs that are typically higher during the 
first 30-day period of care, compared to later 30-day periods of care.
    When we finalized the CPM+NRS approach to calculating the costs of 
care in the CY 2019 HH PPS final rule with comment period, we stated 
that we believe that the use of HHA Medicare cost reports better 
reflects changes in utilization, provider payments, and supply amongst 
Medicare-certified HHAs that occur over time. Under the Wage-Weighted 
Minutes of Care (WWMC) approach, using the BLS average hourly wage 
rates for the entire home health care service industry does not reflect 
changes in Medicare home health utilization that impact costs, such as 
the allocation of overhead costs when Medicare home health visit 
patterns change. Using data from HHA Medicare cost reports better 
represents the total costs incurred during a 30-day period (including, 
but not limited to, direct patient care contract labor, overhead, and 
transportation costs), while the WWMC method provides an estimate of 
only the labor costs (wage and fringe benefit costs) related to direct 
patient care from patient visits that are incurred during a 30-day 
period.
    Comment: A commenter suggested an additional alternative to 
consider regarding the implementation of the PDGM. Specifically, this 
commenter suggested a potential pilot program to test not only the PDGM 
but possibly the PDPM payment system for skilled nursing facilities to 
consider some form of a post-acute bundle with shared savings.
    Response: We appreciate the commenter's suggestions for innovative 
ways to improve the health care system and payment models. However, we 
note that the change in the unit of payment and the case-mix 
methodology is mandated by the BBA of 2018, as such we are required to 
implement such changes beginning on January 1, 2020.
2. Admission Source
    Comment: A commenter stated that it appears counterintuitive to 
have a different reimbursement for community versus institutional 
admission source stating that the goal of home health care is to keep 
the patients out of the hospital. A commenter expressed concern that 
even though the application of an admission source measure may seem 
warranted given data demonstrating different resource use, doing so may 
incentivize agencies to give priority to post-acute patients over those 
who are admitted from the community. This commenter stated that the 
financial impact of the PDGM admission source measure also highlights 
the inherent weakness of all the other PDGM measures. A few commenters 
supported the admission source as an indicator of predicted home health 
resource use.
    Response: We agree that the provision of home health services may 
play an important role in keeping patient's out of the hospital, 
whether the patient is admitted to home health from an institutional 
source or from the community. However, the payment adjustments 
associated with the PDGM case-mix variables are based on the cost of 
providing care. As described in the CY 2018 HH PPS proposed rule (82 FR 
35311), our analytic findings demonstrate that institutional admissions 
have significantly higher average resource use when compared with 
community admissions, which ultimately led to the inclusion of the 
admission source category within the framework of the alternative case-
mix adjustment methodology refinements. Additionally, in the CY 2018 HH 
PPS proposed rule (82 FR 35309), we stated that in our review of 
related scholarly research, we found that beneficiaries admitted 
directly or recently from an institutional setting (acute or post-acute 
care (PAC)) tend to have different care needs and higher resource use 
than those admitted from the community, thus indicating the need for 
differentiated payment amounts. Furthermore, in the CY 2018 proposed 
rule, we provided detailed analysis and research to support the 
inclusion of an admission source category for case-mix adjustment. We 
continue to believe that having a case-mix variable accounting for 
admission source is clinically appropriate, will address the more 
intensive care needs of those admitted to home health from an 
institutional setting, and will more accurately align payment with the 
cost of providing home health care.
    To address concerns that the admission source variable may create 
the incentive to favor institutional admission sources, we fully intend 
to monitor provider behavior in response to the new PDGM. As we receive 
and evaluate new data related to the provision of Medicare home health 
care under the PDGM, we will reassess the appropriateness of the 
payment levels for all of the case-mix variables, including admission 
source, to determine if HHAs are inappropriately changing their 
behavior to favor institutional admission sources over community. 
Additionally, we will share any concerning behavior or patterns with 
the Medicare Administrative Contractors (MACs) and other program 
integrity contractors, if warranted. We plan to monitor and identify 
any variations in the patterns of care provided to home health 
patients, including both increased and decreased provision of care to 
Medicare beneficiaries. We remind stakeholders that the purpose of 
case-mix adjustment is to align payment with the costs of providing 
care. As such, certain case-mix variables may have a more significant 
impact on the payment adjustment than others. However, the case-mix 
variables in the PDGM work in tandem to fully capture patient 
characteristics that translate to higher resource needs. The overall 
payment for a home health period of care under the PDGM is determined 
by the cumulative effect of all of the variables used in the case-mix 
adjustments. Ultimately, the goal of the PDGM is to provide more 
accurate payment based on the identified resource use of different 
patient groups.
3. Therapy Thresholds
    Comment: A few commenters disagreed with the elimination of the 
therapy thresholds and expressed concern that the PDGM design will have 
a negative impact on patients who need therapy services and the HHAs 
that provide it. A commenter stated that therapy services are 
extraordinarily valuable in the care of Medicare home health 
beneficiaries and should be supported to the greatest degree possible. 
Another commenter suggested elimination of the 30-day therapy 
reassessment requirement stating this would duplicative and unnecessary 
under PDGM, given that therapy visits are no longer a payment driver, 
and that all visits must continue to demonstrate a skilled need, 
independent of a formal reassessment. Many commenters urge CMS to 
monitor the effects of PDGM and the implications on therapy utilization 
due to concerns therapy would be underutilized, which could result in 
beneficiaries going to inpatient settings rather than receiving care at 
home. Some commenters recommend further analysis to compare utilization 
of therapy revenue codes under the PPS and PDGM. In addition, 
commenters encourage CMS to use the survey process to ensure that 
beneficiaries continue to receive the appropriate level of therapy that 
were medically

[[Page 60497]]

necessary in order to treat or manage the condition.
    Response: We agree that therapy remains a valuable service for 
Medicare home health beneficiaries. In response to the CY 2018 and 2019 
HH PPS proposed rules, the majority of commenters agreed that the 
elimination of therapy thresholds was appropriate because of the 
financial incentive to overprovide therapy services. While the 
functional impairment level adjustment in the PDGM is not meant to be a 
direct proxy for the therapy thresholds, the PDGM has other case-mix 
variables to adjust payment for those patients requiring multiple 
therapy disciplines or those chronically ill patients with significant 
functional impairment. We believe that also accounting for timing, 
source of admission, clinical group (meaning the primary reason the 
patient requires home health services), and the presence of 
comorbidities will provide the necessary adjustments to payment to 
ensure that care needs are met based on actual patient characteristics. 
Furthermore, services are to be provided in accordance with the home 
health plan of care established and periodically reviewed by the 
certifying physician. Therefore, we expect that home health agencies 
will continue to provide needed therapy services in accordance with the 
CoPs at Sec.  484.60, which state that the individualized plan of care 
must specify the care and services necessary to meet the patient-
specific needs as identified in the comprehensive assessment, including 
identification of the responsible discipline(s), and the measurable 
outcomes that the HHA anticipates will occur as a result of 
implementing and coordinating the plan of care. Upon implementation of 
the PDGM, we will monitor home health utilization, including the 
provision of therapy services. Finally, we remind commenters that 
section 51001(a)(3)(B) of the BBA of 2018 prohibits the use of therapy 
thresholds as part of the overall case-mix adjustment for CY 2020 and 
subsequent years. Consequently, we have no regulatory discretion in 
this matter.
    While we appreciate commenter suggestions to further reduce burden 
by eliminating therapy reassessments, we did not propose to eliminate 
the current 30-day therapy reassessment requirement at Sec.  
409.44(c)(2)(i)(B) in the CY 2020 HH PPS proposed rule. When we 
finalized the 30-day therapy reassessment requirement in the CY 2015 HH 
PPS final rule (79 FR 66103), we stated that the qualified therapist 
assists the physician in evaluating level of function, helps develop 
the plan of care (revising it as necessary), prepares clinical and 
progress notes, advises and consults with the family and other agency 
personnel, and participates in in-service programs. Furthermore, in the 
CY 2015 final rule, the overwhelming majority of commenters recommended 
reassessing the patient at least once every 30 days as the most 
appropriate time frame. Commenters stated that a 30 day reassessment 
timeframe aligns with many state practice acts, which require that a 
therapist reassess the patient at least once every 30 days. As part of 
our response, we also referenced the American Physical Therapy 
Association (APTA) guidelines which state that at least once a month, 
the qualified therapist should conduct a supervisory visit with the 
therapist assistant which should include: An on-site reexamination of 
the patient/client; on-site review of the plan of care with appropriate 
revision or termination; and evaluation of need and recommendation for 
utilization of outside resources.\8\ We also stated that we believe 
that requiring therapy reassessments at least once every 30 days, the 
CoP requirements regarding the plan of care, and the APTA guidelines 
together promote regular interaction between the therapist and the 
patient. However, we recognize the importance of decreasing unnecessary 
burden and we will continue to monitor home health utilization, 
including the provision of therapy visits, to re-evaluate any existing 
policies to determine if any additional changes should be proposed in 
future rulemaking. Likewise, we understand commenter concerns about 
potential underutilization of certain disciplines, especially therapy, 
with the elimination of therapy thresholds. The home health CoPs have 
requirements as to the content of the home health plan of care, as well 
as providing services that are ordered by the physician as indicated in 
the plan of care. Therefore, existing survey mechanisms are in place to 
help ensure patient safety and quality standards. However, as we noted 
in the CY 2019 HH PPS final rule with comment period, upon 
implementation of the PDGM, we will continue to monitor the payment 
system as we have done since the inception of the benefit. We will 
closely monitor patterns related to utilization, including changes in 
the composition of patients receiving the home health benefit and the 
types and amounts of services they are receiving, as well as any 
changes in the settings of care.
---------------------------------------------------------------------------

    \8\ Direction and Supervision of the Physical Therapist 
Assistant. August 30, 2018. https://www.apta.org/uploadedFiles/APTAorg/About_Us/Policies/Practice/DirectionSupervisionPTA.pdf.
---------------------------------------------------------------------------

    Comment: A few commenters support the elimination of therapy as the 
driver of payment and offered historical context to the potential 
increase in therapy utilization as it relates to the Home Health 
Quality Reporting Program. A commenter also identified potential 
opportunity for oversight and monitoring to address ``problematic 
HHAs'' that the commenter identifies as driving the therapy utilization 
data since the inception of the HH PPS. Another commenter stated that 
the elimination of therapy volumes as a determinant of reimbursement is 
appropriate and that they anticipate the clinical groupings based on 
diagnosis, along with the comorbidity adjustments will prove to be 
acceptable elements of payment.
    MedPAC also supports the elimination of therapy as a payment factor 
because their March 2018 Report to Congress \9\ stated concerns about 
the financial incentive to providing more therapy that is not 
necessarily tied to patient characteristics, which is a recognized 
vulnerability in the HH PPS. However, MedPAC believes additional 
monitoring is necessary regarding the 30 day payment to understand 
whether there is a new incentive for HHAs to provide just enough 
services/visits to surpass the threshold for a second 30 day payment.
---------------------------------------------------------------------------

    \9\ MedPAC Report to Congress, Home health care services, March 
2018. https://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch9_sec.pdf?sfvrsn=0.
---------------------------------------------------------------------------

    Response: We appreciate commenter support regarding the elimination 
of the therapy thresholds for use in adjusting home health payment. We 
believe that elimination of the therapy thresholds is more in alignment 
with the intent of the home health benefit to be patient-centered and 
based on patient characteristics, such as functional status, and actual 
patient needs. Likewise, we expect that any services provided would be 
in accordance with all Federal and State laws, including all licensure 
requirements. The provision of skilled therapy services as part of a 
home health plan of care must also adhere to the home health CoPs, (42 
CFR 484.60). We believe that the elimination of the therapy thresholds 
will remove the financial incentive to provide therapy solely for 
increased payment. Upon implementation of the PDGM and the 30-day unit 
of payment, we will continue to monitor home health utilization, 
including the provision of therapy services, as well as any shifts in 
disciplines to determine if

[[Page 60498]]

any program integrity or survey efforts may be warranted.
4. Non-Routine Supplies (NRS)
    Comment: A couple of commenters suggested that CMS should consider 
the higher costs of wound care supplies and should pay more for such 
supplies as part of the PDGM. Another commenter recommended that the 
cost of non-routine supplies (NRS) should be included in outlier 
payments.
    Response: As finalized in the CY 2019 HH PPS final rule with 
comment period (83 FR 56406), similar to the current system, NRS still 
would be paid prospectively under the PDGM, but the PDGM eliminates the 
separate case-mix adjustment model for NRS. We believe that the PDGM 
offers an alternative method for accounting for NRS costs and payments 
by grouping patients more likely to require high NRS utilization. Under 
the PDGM, NRS costs are reflected in the average resource use that 
drives the case-mix weights. If there is a high amount of NRS cost for 
all periods in a particular group (holding all else equal), the 
resource use for those periods will be higher relative to the overall 
average and the case-mix weight will correspondingly be higher. We 
appreciate the commenters' suggestion regarding the inclusion of 
supplies in the outlier calculation under the PDGM. In order to 
incorporate supply costs into the outlier calculation, significant 
claims payment systems modifications would be required. However, after 
implementation of the PDGM, we will continue to monitor the provision 
of NRS and we will consider whether to add supply costs to the outlier 
calculations and evaluate whether such a policy change is appropriate 
for future rulemaking.
5. Clinical Groups
    Comment: Some commenters made general remarks regarding the 
diagnosis codes included in the clinical grouping case-mix variable. A 
few commenters state that elimination of certain diagnosis codes would 
narrow the home health benefit and may prevent access to care to which 
Medicare beneficiaries are legally entitled. Another commenter stated 
that the coding-related proposals could limit the home health benefit 
for eligible beneficiaries in need of skilled maintenance therapy. A 
commenter stated that the removal of certain diagnosis codes from the 
clinical grouping would essentially eliminate coverage for skilled 
services under the home health benefit and said that CMS should not 
finalize elimination of these codes and should recalculate rates with 
all existing codes included.
    Response: The elimination of certain diagnosis codes from the HH 
PPS Grouper is not unique to the PDGM as we have previously removed 
codes from the 153-group HH PPS case-mix system that no longer have a 
significant impact on resource use. As stated previously, the clinical 
grouping is only one case-mix variable in the PDGM. These clinical 
groups are designed to capture the most common types of care that HHAs 
provide. Although the principal diagnosis code is the basis for the 
clinical grouping, secondary diagnosis codes and patient 
characteristics will be used to case-mix adjust the period further 
through the comorbidity adjustment and functional level. We believe 
that the PDGM has a robust set of clinical characteristics to ensure 
that payment accurately aligns with patient needs and therefore, we do 
not expect there to be any issues with patient access to home health 
services. Furthermore, eligibility for home health services remains the 
same as under the 153-group system. That is, individuals are eligible 
for home health services if the following criteria are met: The 
individual is confined to the home; is under the care of a physician; 
is receiving services under a plan of care established and periodically 
reviewed by a physician is in need of skilled nursing care on an 
intermittent basis or physical therapy or speech-language pathology 
therapy; has a continuing need for occupational therapy. Therefore, a 
patient's principal or secondary diagnoses are not sole factors in 
whether a patient is eligible for Medicare home health services. As 
such, eligible beneficiaries are entitled to their Medicare home health 
benefits and we do not expect there to be an access to care issue. With 
respect to the provision of therapy services as they relate to the home 
health period's clinical group, we should emphasize that although the 
principal diagnosis is a contributing factor in the PDGM and determines 
the clinical group, it is not the only consideration in determining 
what home health services are needed in a patient's care plan. We 
stated in the CY 2019 HH PPS proposed rule (83 FR 32401), that it is 
the responsibility of the patient's treating physician to determine if 
and what type of therapy (that is, maintenance or otherwise) the 
patient needs regardless of clinical grouping. As such, we continue to 
expect the ordering physician, in conjunction with the therapist, to 
develop and follow a plan of care for any home health patient, 
regardless of clinical group, as outlined in the skilled service 
requirements when therapy is deemed reasonable and necessary. 
Therefore, a home health period's clinical group should not solely 
determine the type and extent of therapy needed for a particular 
patient.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35313), to 
inform the development of the clinical groups, our home health 
contractor, Abt Associates and CMS conducted an extensive review of 
diagnosis codes to identify the primary reasons for home health 
services under the Medicare home health benefit. The published HHGM 
(predecessor to the PDGM), technical report from December 2016 \10\ and 
the CY 2018 HH PPS proposed rule (82 FR 35314), detail several reasons 
why a diagnosis code was not assigned to one of the clinical groups. 
These included if the diagnosis code was too vague, meaning the code 
does not provide adequate information to support the need for skilled 
home health services (for example H57.9, Unspecified disorder of eye 
and adnexa); the code is subject to laterality for which the home 
health clinician could assess the appropriate side (for example, some 
diagnosis codes indicate laterality, specifying whether the condition 
occurs on the left or right, or is bilateral); the code, based on ICD 
10-CM, American Hospital Association (AHA) Coding Clinic, or Medicare 
Code Edits (MCE) would indicate a non-home health service (for example, 
dental codes); the code is a manifestation code subject to a 
manifestation/etiology convention, meaning that the etiology code must 
be reported as the principal diagnosis, or the code is subject to a 
code first sequencing convention (for example, G99.2 myelopathy in 
diseases classified elsewhere); the code identifies a condition which 
would be unlikely to require home health services (for example, L81.2, 
Freckles); the code is restricted to the acute care setting per ICD 10-
CM/AHA Coding Clinic, or the diagnosis indicates death as the outcome 
(for example S06.1X7A, Traumatic cerebral edema with loss of 
consciousness of any duration with death due to brain injury prior to 
regaining consciousness). Overall, we continue to believe that the PDGM 
clinical grouping includes a robust set of diagnosis codes and includes 
more codes than under clinical dimension of the 153-group case-mix 
system. Therefore, this should afford HHAs greater opportunity to more 
fully describe patient characteristics through

[[Page 60499]]

principal and secondary diagnosis reporting on home health claims.
---------------------------------------------------------------------------

    \10\ ``Overview of the Home Health Groupings Model'' Technical 
Report. November 18, 2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------

    While there are certain diagnosis codes that are not assigned to a 
clinical group under the PDGM for the reasons described, we remind 
commenters that claims submitted with such codes are not denied; rather 
they are returned to the provider for more definitive coding. The 
importance of consistent, complete medical documentation cannot be 
overemphasized. Without such documentation, accurate diagnosis coding 
cannot be achieved; therefore, ICD-10-CM coding guidelines \11\ state 
that the entire record should be reviewed to determine the specific 
reason for the encounter and the conditions treated. We remind 
stakeholders that if there is a question as to what the appropriate 
principal (or secondary) diagnosis should be, the HHA should query the 
certifying physician who is responsible for establishing the home 
health plan of care.
---------------------------------------------------------------------------

    \11\ ``ICD-10-CM Official Guidelines for Coding and Reporting FY 
2020 (October 1, 2019-September 30, 2020). https://www.cms.gov/Medicare/Coding/0ICD10/Downloads/2020-Coding-Guidelines.pdf.
---------------------------------------------------------------------------

    Comment: One industry association stated it had a workgroup conduct 
some analysis on the diagnosis codes and their assigned clinical groups 
and they state that it was discovered that in a significant number of 
instances a code assigned to one clinical grouping was also placed in a 
different clinical grouping. They noted that in every case they 
analyzed where a code was assigned to a different clinical grouping, it 
was assigned to the Complex Nursing group. The commenter requested 
clarification and CMS' rationale so they could share with other 
industry stakeholders.
    Response: We remind commenters that in developing the case-mix 
weights for the PDGM, we examined the principal diagnosis codes 
reported by HHAs and, in order to assign periods of care into the 
appropriate clinical group representing the primary reason for home 
health services, we also looked at OASIS item, M1030, ``Therapies'' 
(identifies whether the patient is receiving intravenous, parenteral 
nutrition or enteral nutrition therapy at home) to see if home health 
patients were receiving complex therapies for which the appropriate 
case-mix adjustment should be made. Therefore, for those circumstances 
in which the workgroup's analysis of the principal diagnosis would have 
grouped the period of care into one of the MMTA subgroups, but the 
actual period was grouped into Complex Nursing Interventions, this is 
likely due to that period of care being assigned based on the response 
to OASIS item M1030, reflecting complex nursing interventions provided 
during the course of home health care. However, we note that for 
implementation of the PDGM in CY 2020 and subsequent years, we have 
assigned ICD-10-CM diagnosis codes to the Complex Nursing Interventions 
group that reflect these more complex therapies previously identified 
from the OASIS item M1030 (for example, Z45.2, Encounter for adjustment 
and management of venous access device) and we will be using the 
diagnosis codes reported on the home health claim and not OASIS items 
to assign a period of care to a clinical group for case-mix adjustment 
purposes.
    Comment: Several commenters stated that symptom codes should be 
allowed to be reported as the principal diagnosis and assigned to a 
clinical group. A few commenters stated that disallowing symptom codes 
for principal diagnosis consideration will cause HHAs to report a 
principal diagnosis that would not truly represent the reason for the 
home health encounter and would force HHAs to ``upcode''. A commenter 
remarked that there is a significant portion of the elderly population 
who exhibit symptomology but have declined further testing or the 
medical community has decided not to order expensive tests since many 
times the treatment remains the same. Several symptom codes were 
specifically mentioned for inclusion in the clinical group variable by 
a national industry association, as well as HHAs. Commenters suggested 
that the following symptom codes should be in the MS Rehab clinical 
group:

 R26.89, Other abnormalities of gait and mobility
 R29.6, Repeated falls

    The following symptom codes were suggested to be included in the 
clinical group variable, but without a recommendation for a specific 
PDGM clinical group:

 R00.1, Bradycardia
 R41.82, Altered Mental Status
 R42, Dizziness and giddiness.

    And, several commenters suggested the following symptom codes 
should be in the Neuro Rehab clinical group:

 R27.0, Ataxia, unspecified
 R13.10, Dysphagia

    Response: As we have stated in the CY 2020 proposed rule and this 
final rule with comment period, we do not support or condone coding 
solely for purposes of higher payment (what commenters refer to as 
``upcoding''). In accordance with ICD-10-CM coding guidelines, the 
principal diagnosis reported is that ``condition established after 
study to be chiefly responsible for occasioning the admission of the 
patient to the hospital for care.'' For purposes of home health care 
admission, this would be the diagnosis chiefly responsible for home 
health services. Because of the home health requirements that the 
individual receiving home health services must be certified for such 
services and must have had a face-to-face encounter related to the 
primary reason for home health care, we believe that by the time an 
individual is admitted to home health, the patient has been seen by 
other health care providers and a diagnosis has been established. We 
note that we adopted a similar position as it relates hospice diagnosis 
reporting. In the FY 2014 hospice proposed rule (78 FR 27831), we 
stated that if a nonspecific, ill-defined symptom diagnosis is reported 
as the principal hospice diagnosis, a comprehensive, individualized 
patient-centered plan of care, as required, may be difficult to 
accurately develop and implement, and, as a result, the hospice 
beneficiary may not receive the full benefit of hospice services. We 
believe that the same principle applies to home health beneficiaries 
and that accurate documentation and diagnosis reporting is essential to 
ensure that an individualized plan of care is established to meet the 
patient's home health needs. Furthermore, the ICD-10-CM coding 
guidelines state that codes for symptoms, signs, and ill-defined 
conditions are not to be used as the principal diagnosis when a related 
definitive diagnosis has been established. Therefore, because of the 
inclusion of a clinical group for case-mix adjustment purposes 
predicated on diagnosis reporting, we believe that HHAs would improve 
their overall documentation and accuracy of their diagnosis code 
reporting to reflect patient characteristics defined by diagnosis 
codes, as well as other important patient information that reflects 
resource utilization (for example functional impairment). As such, we 
believe that the reporting of ill-defined symptom codes as the 
principal diagnosis would be less frequent.
    As we stated in the CY 2019 HH PPS final rule with comment period 
(83 FR 56473), we believe that the majority of the R-codes (codes that 
describe signs and symptoms, as opposed to diagnoses) are not 
appropriate as principal diagnosis codes for grouping home health 
periods into clinical groups. We

[[Page 60500]]

believe that the use of symptoms, signs, and abnormal clinical and 
laboratory findings would make it difficult to meet the requirements of 
an individualized plan of care as required at Sec.  484.60. Likewise, 
we believe that clinically it is important for home health providers to 
have a clear understanding of the patients' diagnoses in order to 
safely and effectively furnish home health services. Interventions and 
treatment aimed at mitigating signs and symptoms of a condition may 
vary depending on the cause. For example, if a patient has been 
referred to home health with a diagnosis of ``other abnormalities of 
gait and mobility'' (R26.89), we believe it is important for the home 
health clinician to know what is precipitating the abnormality. For 
instance, a plan of care for a gait abnormality related to a 
neurological diagnosis is likely to be different from a plan of care 
for a gait abnormality due to a fracture or injury. Anecdotally, we 
have heard that the home health referral may be non-specific or that 
the physician may be in the process of determining a more definitive 
diagnosis. However, with respect to patient safety and quality of care, 
we believe it is important for a clinician to investigate the cause of 
the signs and/or symptoms for which the referral was made. This may 
involve calling the referring physician to gather more information 
regarding the gait abnormality. We note that HHAs are required under 
the home health CoPs at Sec.  484.60 to participate in care 
coordination to assure the identification of patient needs and factors 
that could affect patient safety and treatment efficacy. ICD-10-CM 
coding guidelines are clear that R-codes are to be used when no more 
specific diagnosis can be made even after all the facts bearing on the 
case have been investigated. Therefore, these codes should not be used 
as a principal diagnosis for the provision of home health services 
while a physician may still be in the diagnostic process. By the time 
the patient is referred to home health and meets the qualifications of 
eligibility, we would expect that a more definitive code would 
substantiate the need for services. Furthermore, commenters have 
indicated a preference for greater specificity in the clinical groups, 
therefore, we believe this should extend to the codes within the 
clinical groups as well.
    Regarding commenters suggesting that R29.6, Repeated falls, be 
included in the MS Rehab group, we note that ICD-10-CM coding 
guidelines state to only use R29.6 for use for encounters when a 
patient has recently fallen and the reason for the fall is being 
investigated. Given that the patient must be certified for home health 
services and must have had a face-to-face encounter related to the 
primary reason for home health services, we do not believe that this 
particular symptom code would be appropriate for the principal 
diagnosis to substantiate home health services. We believe that by the 
time a home health referral is made, a more clearly defined diagnosis 
would have been established to more accurately describe the patient's 
condition. However, if the patient's condition has resulted in repeated 
falls, the HHA would report Z91.81, History of falling, as a secondary 
diagnosis to describe that the patient has fallen in the past and is at 
future risk for falls to more accurately describe the patient's need 
for home health services. For the same reasons as stated throughout 
this response, we do not believe it appropriate to include R00.1 
Bradycardia, R41.82, Altered Mental Status, or R42, Dizziness and 
giddiness as part of the clinical group case-mix variable because of 
the vague nature of symptom codes where there could be multiple reasons 
for such symptoms. In order to develop an appropriate, individualized 
home health plan of care, we believe it is clinically essential to 
understand the causes of such symptoms to safely and effectively 
provide home health services. Furthermore, it has been our longstanding 
policy to avoid vague diagnoses for reporting and payment purposes. 
Specifically, we stipulated in the 2008 HH PPS final rule (72 FR 49774) 
that the case-mix system avoid, to the fullest extent possible, non-
specific or ambiguous ICD-9-CM codes, codes that represent general 
symptomatic complaints in the elderly population, and codes that lack 
consensus for clear diagnostic criteria within the medical community. 
We note that diagnosis codes R00-R99 include symptoms, signs, abnormal 
results of clinical or other investigative procedures, and ill-defined 
conditions are limited for those circumstances where there is no 
recorded diagnosis that is classifiable elsewhere. However, patients 
are referred to home health from other clinical settings (either from a 
facility or a community-based provider) and therefore, we believe that 
the medical records from such referral source should provide 
information as to the need for home health services, including the 
diagnoses established by such providers. Clinically, this information 
is needed to develop the individualized plan of care with patient-
specific goals. In the circumstance where such information is missing 
or insufficient, we believe that HHAs should query these referring 
providers to ensure they have a clear understanding of the conditions 
affecting patients in need of home health services.
    Regarding suggestions to include the symptom codes R27.0, Ataxia, 
unspecified, and R13.10, Dysphagia, in the Neuro Rehab clinical group, 
we reiterate our position as noted previously--that by the time a 
patient is admitted for home health services, there should be 
sufficient documentation in the patient's medical record to have an 
established diagnosis, and that a symptom diagnosis should not be 
reported as the principal diagnosis as this could be the result of 
other conditions besides a neurological condition and therefore, 
grouping the period of care into Neuro Rehab may not be appropriate. We 
continue to believe that the home health clinician needs appropriate, 
accurate clinical information, including the cause of such symptoms, in 
order to develop an individualized plan of care to specify the services 
necessary to meet the patient-specific needs.
    However, we analyzed the frequency of the reporting of each of 
these diagnoses and we note that in 2018, there were only 3,461 30-day 
periods in which R27.0, Ataxia, unspecified, was reported as the 
principal diagnosis. However, in looking at the reported secondary 
diagnoses accompanying this principal diagnosis, HHAs reported 
established diagnoses that could explain the reason for the unspecified 
ataxia and would group the 30-day period of care into the Neuro Rehab 
group. For example, we found reported secondary diagnoses of 
Alzheimer's disease, Parkinson's disease, and polyneuropathy. Given 
that symptom diagnoses should not be reported as the principal 
diagnosis if there is an established diagnosis, we believe that the 
established diagnosis would be reported first, and the symptom code, 
unspecified ataxia, would be reported as a secondary diagnosis to fully 
reflect patient characteristics. Furthermore, in reviewing the tabular 
index in the CY 2020 ICD-10-CM official code set \12\ for ``ataxia'', 
there are multiple diagnosis codes available to more accurately 
describe the underlying condition causing the ataxia. We also note that 
``unspecified'' codes should only be reported when the medical record 
is

[[Page 60501]]

insufficient to assign a more specific code.
---------------------------------------------------------------------------

    \12\ 2020 ICD-10-CM web page. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM.html.
---------------------------------------------------------------------------

    We also analyzed the frequency of reporting of R13.10, dysphagia, 
unspecified and we note that in 2018, there were approximately 28,000 
30-day periods in which this particular code was reported as the 
principal diagnosis. In looking at the reported secondary diagnoses 
accompanying this principal diagnosis, we found that while there were 
incidences where there were other reported diagnoses which could 
explain the reason for the dysphagia, more often than not, there was no 
clear clinical picture of the possible etiology where a different 
reported principal diagnosis would signal the need for therapy. 
Furthermore, we received comments on this particular diagnosis stating 
that while there are diagnosis codes for dysphagia resulting from a 
cerebrovascular event (for example, stroke) and others resulting from 
somatoform disorders (for example, psychogenic dysphagia), there are 
very few disease-specific diagnosis codes to identify associated 
dysphagia (for example, dysphagia resulting from throat cancer 
treatment). A review of the CY 2020 ICD-10-CM official code set tabular 
index, showed that the majority of codes to describe dysphagia are the 
R13 codes. We recognize that dysphagia codes associated with a 
cerebrovascular event would be assigned to the Neuro Rehab clinical 
group and commenters stated that those patients with dysphagia due to 
etiologies not associated with cerebrovascular events would most often 
require speech-language pathology therapy if the primary reason for 
home health services is for the dysphagia. Given the current lack of 
other definitive diagnoses to describe certain forms of dysphagia, we 
agree that the R-codes to describe dysphagia would be acceptable for 
reporting the primary reason for home health services. Therefore, we 
will assign the following R-codes to the Neuro Rehab clinical group:

 R13.10, Dysphagia, unspecified
 R13.11, Dysphagia, oral phase
 R13.12, Dysphagia, oropharyngeal phase
 R13.13 Dysphagia, pharyngeal phase
 R13.14, Dysphagia, pharyngoesophageal phase
 R13.19, Other dysphagia

    While we understand that dysphagia could be the result of non-
neurological conditions, we are assigning these dysphagia groups to the 
Neuro Rehab group as we believe the intensity of speech-language 
pathology therapy would be similar to those suffering from dysphagia 
resulting from a neurological condition. However, we will monitor the 
use of these dysphagia R-codes to determine their impact on resources 
utilization and whether any future changes would be warranted.
    Finally, we remind commenters that ICD-10-CM coding guidelines 
state that codes for signs and symptoms may be reported in addition to 
a related definitive diagnosis when the sign or symptom is not 
routinely associated with that diagnosis, such as signs and symptoms 
associated with complex syndromes. The definitive diagnosis should be 
sequenced before the symptom code. Signs or symptoms that are 
associated routinely with a disease process should not be assigned as 
secondary codes, unless otherwise instructed by the classification. 
Therefore, we expect that HHAs would report the principal and secondary 
diagnoses that affect the home health plan of care and justify the need 
for home health services.
    Comment: We received specific coding comments from national 
industry associations as well as well as from other HHAs, with 
recommendations to change or add the following codes to the clinical 
group variable.
    Response: Table 12 lists these codes and the commenters recommended 
clinical group, as well as our response to these recommendations:
BILLING CODE 4120-01-P

[[Page 60502]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.012


[[Page 60503]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.013


[[Page 60504]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.014


[[Page 60505]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.015


[[Page 60506]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.016


[[Page 60507]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.017


[[Page 60508]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.018

BILLING CODE 4120-01-C

[[Page 60509]]

    We note that as we were examining the clinical group changes 
suggested by commenters, we took the opportunity to ensure consistency 
in the clinical group assignments and have reassigned certain diagnosis 
codes accordingly. Specifically, we are reassigning the following 
codes:
[GRAPHIC] [TIFF OMITTED] TR08NO19.019


[[Page 60510]]


    Comment: Several commenters stated that code M62.81 Muscle Weakness 
(generalized) should be allowed to be reported as the principal 
diagnosis used to assign a clinical group. Commenters stated that it is 
problematic to exclude this code, as there are scenarios in which 
patients are seen in the home for muscle weakness when the underlying 
etiology is unknown, or when the original condition, causing the 
weakness is resolved. Additionally, commenters noted that M62.81 is 
identified as a diagnostic code to support medical necessity for home 
health therapy services by the MACs within their local coverage 
determinations. While commenters agreed that this diagnosis lacks 
specificity, they stated that they disagree that this diagnosis would 
not be deemed medically necessary. And finally, commenters stated that 
when evaluating the assignation of a diagnosis code at the point of 
care in home health, the coding specialist must consider the available 
documentation.
    Response: As we stated in the CY 2019 HH PPS final rule with 
comment period (83 FR 56474), M62.81, ``Muscle weakness, generalized'' 
is a vague code that does not clearly support a rationale for skilled 
services. Further, the lack of specificity for this code does not 
support a comprehensive plan of care. We noted that Sec.  
409.44(c)(1)(ii) states that ``the patient's clinical record must 
include documentation describing how the course of therapy treatment 
for the patient's illness or injury is in accordance with accepted 
professional standards of clinical practice.'' If there is not an 
identified cause of muscle weakness, then it would be questionable as 
to whether the course of therapy treatment would be in accordance with 
accepted professional standards of clinical practice.
    Additionally, it is not without precedent that CMS has been 
disinclined to include generalized muscle weakness in the home health 
case-mix. In the 2008 HH PPS final rule, we identified generalized 
muscle weakness as a nonspecific condition that represents general 
symptomatic complaints in the elderly population. We stated that 
inclusion of this code ``would threaten to move the case-mix model away 
from a foundation of reliable and meaningful diagnosis codes that are 
appropriate for home care'' (72 FR 49774). The 2008 HH PPS final rule 
stated that the case-mix system avoid, to the fullest extent possible, 
non-specific or ambiguous ICD-9-CM codes, codes that represent general 
symptomatic complaints in the elderly population, and codes that lack 
consensus for clear diagnostic criteria within the medical community. 
Expanding upon that assertion, we stated in the CY 2019 final rule with 
comment period that diagnostic approaches to determining the cause of 
muscle weakness, polyneuropathy, and other vague conditions, combined 
with the expanded ICD-10 list, ensure that codes exist which more 
clearly describe a patient's need for home health (83 FR 56474). With 
respect to commenter rationale for coding generalized muscle weakness 
when the underlying etiology is unknown, we believe that by the time a 
home health referral is made, a more definitive principal diagnosis is 
warranted in order to justify the need for skilled services and 
appropriate treatment. Further, if the original condition is resolved, 
but the resulting muscle weakness persists as a result of the known 
original diagnosis, we anticipate that a more specific code exists that 
accounts for why the muscle weakness is on-going, such as muscle 
wasting or atrophy. As the commenter pointed out, the coding specialist 
must consider available documentation; however, as we state in the 
previous discussion regarding symptom codes, we believe it is important 
for a clinician to investigate the reason for which the referral was 
made. This may involve calling the referring physician if the original 
condition is resolved and is not included in the referral 
documentation.
    With respect to commenter reference to the LCD for Physical Therapy 
in Home Health (L33942), we recognize that M62.81 is identified as a 
code to support medical necessity. While we are not disputing that 
services for this diagnosis are considered reasonable and medically 
necessary, we do not believe it is appropriate to list Muscle weakness, 
generalized as a principal diagnosis in order to group the home health 
period. We developed the clinical groupings in large part to clearly 
identify the need for the home health episode, including the skilled 
services involved. Allowing use of a vague code that does not clearly 
denote a treatment plan, would invalidate the transparency we hope to 
achieve in the home health payment system.
6. Comorbidities
    Comment: A commenter questioned why the list of comorbidity codes 
stopped at the R codes and indicated there should be codes for 
``traumas, postoperative complications and the Z codes''. The same 
commenter questioned why some codes were included in the overall 
comorbidity list but not all were eligible for a comorbidity 
adjustment. A commenter requested an explanation the rationale for not 
including any conditions from the ICD-10-CM chapters with O, P, Q, R, 
S, T, or Z codes as comorbidity diagnoses as many of these seem 
appropriate given the significant impact these conditions have on the 
patient's recovery.
    Another commenter questioned why blindness and other low vision 
codes (Neuro 11) were removed from the comorbidity grouping given their 
significance in patient treatment and recovery.
    Response: As we described in the CY 2018 HH PPS proposed rule (82 
FR 35322), we examined multiple approaches for a comorbidity adjustment 
in the alternate case-mix adjustment methodology and the analyses on 
these approaches are found in the ``Overview of the Home Health 
Groupings Model'' technical report found on the HHA Center web page. As 
we noted in the technical report, secondary diagnosis reporting on the 
OASIS and home health claims was not as robust as would be expected. As 
part of that analysis, we also examined claims from prior settings 90 
days before the home health start of each home health episode. Again, 
our analysis showed that diagnosis reporting was not as robust as 
hypothesized, especially in Part B physician claims where diagnoses 
reported appeared to be specific to only the condition for which the 
patient sought care. Furthermore, many secondary diagnosis codes, 
including those associated with signs, symptoms, and other ill-defined 
conditions (that is, R-codes) often had an inverse relationship with 
resource use, meaning the presence of these symptom codes showed less 
resource use for home health periods of care. Based on the results of 
these analyses, we proposed and finalized a home health specific 
comorbidity list for the PDGM comorbidity adjustment, as described in 
the technical report and in the CY 2018 and CY 2019 HH PPS proposed and 
final rules. The home health-specific comorbidity list is based on the 
principles of patient assessment by body systems and their associated 
diseases, conditions, and injuries to develop larger categories of 
conditions that identified clinically relevant relationships associated 
with increased resource use. While we are aware of the prevalence of 
comorbidities, including those associated with symptoms, in the 
Medicare home health population, we note that the average number of 
comorbidities in the aggregate becomes the standard within that 
population for the purpose of payment. As such, the PDGM comorbidity 
adjustment includes

[[Page 60511]]

those comorbid conditions and interaction subgroups that represent more 
than 0.1 percent of periods and that have at least as high as the 
median resource use. While there are additional comorbid diagnoses 
included in the home health-specific list, we note that not all 
diagnoses are included in a comorbidity subgroup that meets the 
criteria to receive an adjustment. However, it is expected that HHAs 
will report those secondary diagnoses that affect care planning and we 
will continue to evaluate reported secondary diagnoses and interactions 
between comorbidities to identify their impact on resource costs to 
determine if any future refinements to this case-mix adjustment 
variable are warranted.
    Regarding the exclusion of diagnosis codes from the ICD-10-CM 
chapters starting with ``O'', ``P'', or ``Q'', we note that these are 
diagnosis codes that reflect conditions of pregnancy, childbirth and 
the puerperium (O00-O9A),certain conditions originating in the 
perinatal period (P00-P96), and congenital malformations, deformations, 
and chromosomal abnormalities (Q00-Q99). As such, because we were 
examining reported diagnoses on Medicare home health claims, these were 
diagnoses that were not generally reported given the nature of the 
Medicare patient population. Secondary diagnosis codes identifying 
signs, symptoms and other ill-defined conditions (R-codes, R00-R99) 
were examined as part of our analysis for possible inclusion on the 
comorbidity list, however, these generally did not show any significant 
correlation on resource use and therefore were not included in the home 
health specific comorbidity diagnosis list. We note, however, that 
R00.1, bradycardia, unspecified, is on the comorbidity diagnosis list 
and is included under the comorbidity subgroup, Heart 10, which does 
meet the comorbidity adjustment criteria and receives additional 
payment. The same holds true with the codes that begin with ``S'' or 
``T'', representing injury, poisoning, and certain other consequences 
of external causes (S00-T88) where these codes were not frequently 
reported as secondary diagnoses on home health claims. Furthermore, we 
described in detail, in the CY 2018 proposed rule (82 FR 35322), how we 
developed the home health specific comorbidity diagnosis list, focusing 
on those chronic conditions that our literature review, and our data 
analysis, showed to be clinically and statistically significant on 
their overall impact on home health resource use. Finally, we note that 
there are diagnosis codes representing blindness and other low-vision 
conditions on the home health specific comorbidity list (the Neuro 11 
subgroup). However, when analyzing CY 2018 home health claims for the 
CY 2020 comorbidity adjustment, these particular diagnosis codes did 
not represent more than 0.1 percent of periods or have at least as high 
as the median resource use and therefore, will not receive a 
comorbidity adjustment in CY 2020. We take this opportunity to remind 
commenters that there are diagnosis codes on the home health specific 
list that will not receive the adjustment in CY 2020, but that does not 
mean that these would never receive an adjustment. Based on our 
extensive literature review and previous comments received on what 
clinically significant secondary diagnoses to include as part of this 
home health specific list, we believe that if HHAs are reporting these 
as secondary diagnoses and they have an impact on home health resource 
use (that is, represent more than 0.1 percent of home health periods of 
care and have at least as high as the medial resource use), these 
diagnoses could receive a comorbidity payment adjustment in future 
years. As such, the comorbidity subgroups that could receive an 
adjustment in any given year is fluid, depending on the frequency of 
the reported codes and their impact on resource use. Therefore, we 
remind commenters of the importance of reporting secondary diagnoses on 
the home health claim, regardless of whether there is a comorbidity 
payment adjustment associated with such diagnosis. Likewise, we will 
continue to examine reported secondary diagnoses on home health claims 
and their relationship with resource use to determine whether such 
diagnoses should be included on the home health specific comorbidity 
list in future years.
    Comment: A few commenters noted that there are separate 
instructions for reporting other/secondary diagnoses on the claim, the 
OASIS instructions, the CoPs and the interpretive guidelines. These 
commenters recommended that CMS modify all of these instructions with 
ICD-10-CM coding guidelines to be consistent with the expectations for 
reporting of diagnoses.
    Response: The ICD-10-CM coding guidelines \13\ define ``other'' 
(additional) diagnoses as ``all conditions that coexist at the time of 
admission, that develop subsequently, or that affect the treatment 
received and/or the length of stay.'' The OASIS manual instructions 
\14\ state that ``secondary diagnoses are comorbid conditions that 
exist at the time of the assessment, that are actively addressed in the 
patient's plan of care, or that have the potential to affect the 
patient's responsiveness to treatment and rehabilitative prognosis''. 
The CoPs at Sec.  484.60 state that the home health plan of care must 
include all ``pertinent diagnoses'' and the accompanying interpretive 
guidelines state that this means that all ``known diagnoses''. While we 
recognize that there could be a perceived difference between the 
various descriptions, we believe that these instructions essentially 
describe the same thing. Specifically, all of these coding instructions 
state to include any conditions that exist at the time of home health 
admission, or that develop during the course of a home health period of 
care, and that affect patient care planning. That is, diagnoses should 
be reported that affect or potentially affect patient care (and 
therefore would be addressed in the home health plan of care), even if 
such care includes observation and assessment (for actual or potential 
effects), teaching and training, or direct patient care interventions.
---------------------------------------------------------------------------

    \13\ ICD-10-CM Official Guidelines for Coding and Reporting FY 
2020. https://www.cdc.gov/nchs/data/icd/10cmguidelines-FY2020_final.pdf.
    \14\ ``Outcome and Assessment Information Set OASIS-D Guidance 
Manual'', Effective January 1, 2019 https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/draft-OASIS-D-Guidance-Manual-7-2-2018.pdf.
---------------------------------------------------------------------------

    Final Decision: We note that the PDGM was finalized in the CY 2019 
HH PPS final rule with comment period (83 FR 56406), and therefore, no 
structural changes to this case-mix adjustment methodology have been 
made in this CY 2020 final rule with comment period. Therefore, we are 
finalizing the implementation of the PDGM for 30-day periods of care 
beginning on and after January 1, 2020. We are finalizing the coding 
changes for the clinical group as described in responses to the various 
diagnosis/clinical group comments. These coding changes will be 
reflected in the Interactive Grouper Tool posted on the HHA Center web 
page and also in the downloadable HH PPS grouper \15\ that accompanies 
the publication of this final rule with comment period.
---------------------------------------------------------------------------

    \15\ Home Health PPS Software web page. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware.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

[[Page 60512]]

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 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 final rule with comment period (83 FR 56461), 
we finalized three assumptions about behavior changes 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 
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 based on past evidence and as detailed in the CY 2020 
proposed and this final rule with comment period.
     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 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 PDGM, we 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.\16\ 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 final rule with comment 
period for the LUPA thresholds that correspond to the 432 case-mix 
groups under the PDGM).
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    \16\ 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.
---------------------------------------------------------------------------

    For this final rule with comment period, in order to calculate the 
CY 2020 budget neutral 30-day payment amounts 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.C. 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 $16.6 billion.\17\ 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 rule) and in order for Medicare to pay 
out $16.6 billion in total expenditures in CY 2020 with the application 
of a 30-day unit of payment under the PDGM. Table 14 includes the 30-
day budget-neutral payment amount for CY 2020 both with and without the 
behavior assumptions based on the most current data available at the 
time of this final rule with comment period. These amounts vary 
slightly from those in Table 12 of the proposed rule (84 FR 34616) due 
to using more up-to-date data. These payment amounts do not include the 
CY 2020 home health payment update of 1.5 percent.
---------------------------------------------------------------------------

    \17\ The final 2018 analytic file included 6,3388,974 60-day 
episodes ($18.0 billion in total expenditures as shown on the 
claim). Of these, 609,947 (9.5 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 
rule. We note that of the 609,947 excluded claims, 142,206 were 
excluded because they were RAPs without a final claim or they were 
claims with zero payment amounts, resulting in $17.9 billion in 
total expenditures (as shown on the claim). After removing all 
609,947 excluded claims, the 2018 analytic file consisted of 
5,779,027 60-day episodes ($16.6 billion in total expenditures ass 
shown on the claim). 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 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 9,336,898 30-day periods 
($16.6 billion in total expenditures that are simulated under the 
PDGM) drawn from 5,471,454 60-day episodes.

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[[Page 60513]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.020

    If no behavior assumptions were made, we estimate that the CY 2020 
30-day payment amount needed to achieve budget neutrality would be 
$1,908.18. 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, would result in the need to decrease the 
CY 2020 budget-neutral 30-day payment amount to $1,748.11 (an 8.389 
percent decrease from $1,908.18). The CY 2020 estimated 30-day budget-
neutral payment amount would be slightly less 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 $1,748.11 does not include the 1.5 percent home 
health legislated payment update for CY 2020. Applying the CY 2020 Wage 
Index Budget Neutrality Factor and the 1.5 percent home health update 
as described in section III.E. of this final rule with comment period) 
would increase the CY 2020 national, standardized 30-day payment amount 
to $1,785.51. The CY 2020 estimated payment rate of $1,785.51 is 
approximately 11 percent more than the estimated CY 2020 30-day period 
cost of $1,608.82, as shown in Table 5 of this final rule with comment 
period.
    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.E.4.b of this final rule 
with comment period. 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.E.4.d. of this final rule with comment period. 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. We noted in the proposed rule that 
complete 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 noted 
that we would analyze preliminary 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. 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 notice and comment rulemaking.
    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

[[Page 60514]]

overestimates the reductions, we are required to make the appropriate 
payment adjustments accordingly as described previously.
    We solicited comments on the proposed, estimated CY 2020 30-day 
budget neutral payment amount, as well as any potential issues that may 
result from taking these behavior assumptions into account when 
establishing the initial 30-day payment amounts for CY 2020. We did not 
propose any changes to the behavior assumptions finalized in the CY 
2019 HH PPS final rule with comment period (83 FR 56461). We received 
186 comments on the behavior assumptions finalized in the CY 2019 HH 
PPS final rule with comment period and the proposed 30-day payment 
amount for CY 2020 from various stakeholders including home health 
agencies, industry associations, individual clinicians, and MedPAC. 
These comments and our responses are summarized in this section of this 
final rule with comment period.
    Comment: Several commenters disagreed with the behavior assumptions 
finalized in the CY 2019 HH PPS final rule with comment period. 
Commenters added that given the current regulatory and audit 
environment, agencies who are coding diagnoses strictly for payment 
maximization must still keep their focus of care as the primary 
consideration in coding or their payments will be denied. Commenters 
went on to state that the home health agency can only code what is 
already in the medical record and that has been diagnosed by a 
physician, so there is a limit to which diagnoses may be selected. A 
commenter stated that CMS is creating an environment wherein agencies 
will have to modify their coding practices in order to survive. This 
commenter stated HHAs that would not normally alter their behavior 
without the reduction will now be forced to.
    Response: We continue to believe that the behavior assumptions are 
reasonable given past experience with changes in provider behavior in 
response to payment system modifications. We refer readers to the CY 
2019 HH PPS final rule with comment period (83 FR 56456), in which we 
provided examples of observed behavior changes resulting from payment 
system changes. These examples included the behavior changes resulting 
from the transition from diagnosis-related groups (DRGs) and the 
Medicare Severity (MS)-DRGs under the inpatient prospective payment 
system, and nominal case-mix growth observed from the 2008 changes to 
the HH PPS case-mix model that resulted in the current 153 home health 
resource groups. We also believe that there may be additional behavior 
changes that may result from the change to a new case-mix adjustment 
methodology that relies more heavily on patient characteristics. For 
example, given the significant number of ICD-10-CM diagnosis codes that 
are assigned to a clinical group, HHAs may start reporting diagnoses 
that were not typically reported on home health claims under the 
current 153-group model. As we stated in the CY 2020 HH PPS proposed 
rule (84 FR 34614), we do not support or condone coding practices or 
the provision of services solely to maximize payment. We fully expect 
that HHAs would report those diagnoses (both the principal diagnosis 
and secondary diagnoses) that reflect the primary reason for home 
health services and those that affect the home health plan of care. 
This is in accordance with ICD-10-CM coding guidelines, which state to 
select the principal diagnosis code that reflects the reason for the 
health care encounter, and to report the additional diagnoses that 
affect patient care in terms of clinical evaluation, therapeutic 
treatment, and increased nursing care or monitoring. Furthermore, the 
specificity and granularity of ICD-10-CM diagnosis codes provide the 
opportunity for HHAs to improve their diagnosis code reporting to more 
accurately reflect the reason for home health services and other 
conditions that affect the home health plan of care. If the supporting 
documentation from the certifying physician or the acute/post-acute 
care facility is lacking specificity regarding the patient's diagnoses, 
the HHA would be expected to query such providers in order to 
adequately address the patient's home health care needs.
    Because one of the variables in the PDGM case-mix adjustment is the 
clinical grouping, we believe that HHAs would be more comprehensive in 
their assessment of the patient to identify all diagnoses to determine 
the individualized patient care needs to be addressed through the home 
health plan of care. More specific and accurate diagnosis reporting to 
identify those conditions affecting the home health plan of care and to 
support the need for services is appropriate. Likewise, the home health 
Conditions of Participation (CoPs) at Sec.  484.60(a), require that the 
home health plan of care includes all pertinent diagnoses. HHAs are 
required to consult the physician if there are any additions or 
modifications to the plan of care. Therefore, any diagnoses included on 
the home health plan of care would have to be agreed upon by the 
physician responsible for the home health plan of care. More accurate 
and complete reporting of diagnoses is not inappropriate if in 
accordance with existing regulations and standards of practice. 
Modification of current coding practices does not mean that HHAs are 
engaging in inappropriate behavior nor are the coding assumptions meant 
to encourage any type of negative behavior change. As noted previously, 
ICD-10-CM diagnosis codes are granular and specific, and provide HHAs a 
better opportunity to report those codes that reflect the patient's 
conditions and support the need for home health services. We view 
improved diagnosis reporting as a positive change that affords HHAs the 
latitude to fully ``paint the picture'' of their patients receiving 
home health services.
    Comment: Many commenters stated that the behavior assumptions 
finalized are ``faulty'' with no empirical evidence to support such 
assumptions or that the behaviors would actually occur. Most often, 
commenters stated that while changes in coding behavior may occur, the 
degree to which this may occur and the impact of the occurrence, 
especially in the first year of the new payment system seems to be 
exaggerated by CMS. Several commenters stated that their home health 
agencies do not ``game the system'' and base patients' care plans on 
what patients need. These commenters believe that they should not be 
subjected to payment cuts based on Medicare's assumptions, which they 
believe to be flawed. A few commenters stated that the behavior 
assumptions penalize those agencies who have been providing care based 
on patient need and not driven by therapy utilization or other 
behaviors solely to maximize payment. These commenters indicated that 
they would not change their current care practices because of this 
regulation and that they were essentially being punished for doing the 
right thing all along. They expressed concern over how they would 
adjust to compensate for an 8 percent reduction in the 30-day payment 
rate. Other commenters recommended that CMS establish monitoring 
programs to target providers engaging in in specific behaviors solely 
for payment purposes rather than ``penalize all providers.'' Several 
comments indicated that the behavioral assumptions are a punitive 
action against all home health agencies based on behaviors that have 
not happened yet and may never happen.
    Response: We disagree that the finalized behavior assumptions are 
without empirical evidence as we have provided multiple examples of 
previous changes in behavior in response to payment changes, especially 
as they

[[Page 60515]]

relate to coding behavior. In the CY 2020 HH PPS proposed rule (83 FR 
56456), we provided examples of such evidence. For the clinical group 
and comorbidity assumptions when CMS implemented revisions to the home 
health case-mix system in 2008, subsequent analysis found that 
behavioral responses unrelated to patient severity caused payments to 
increase by 4 percent in that year--despite having increased only 1 
percent per year, on average, between 2001 and 2007. CMS continued to 
find nominal increases in case mix unrelated to patient severity in 
later years and reduced payments by an average of 1.8 percent a year 
from 2008 through 2017 to account for this trend. We refer commenters 
to the impact of the coding and comorbidity assumptions in Table 14 of 
this rule, which is estimated to be 6.4 percent and 0.25 percent 
respectively, which is similar to other past coding behavior responses 
described previously and which were associated with the implementation 
of a new home health payment system.
    We also provided additional examples from other Medicare payment 
systems where coding behaviors led to increases in payment not 
necessarily related to increases in patient acuity. These include the 
transition from DRGs to (MS) DRGs; the first year of the IRF PPS; and 
Maryland's transition to APR DRGs. For the LUPA assumptions, we 
provided the analysis of the implementation of the HH PPS where the 
expected rate of LUPAs (16 percent) was much higher than the actual 
rate of LUPAs (7 percent), indicating that HHAs were providing extra 
visits to receive a full 60-day episode case-mix adjusted payment 
amount.
    Additionally, section 1895(b)(3)(A)(iv) of the Act requires us to 
make assumptions about behavior changes that could occur as a result of 
the change to a 30-day unit of payment and implementation of the PDGM 
when calculating a 30-day payment amount in a budget-neutral manner. 
These assumptions are not to account for ``gaming'' of the system as 
commenters suggest, and we stated as such in the CY 2019 HH PPS 
proposed rule (83 FR 56455). We clarified that CMS often takes into 
account anticipated behaviors when making a payment system change. By 
including behavior change assumptions in the proposed calculation of 
the 30-day payment amount, as required by statute, we did not intend to 
imply that HHAs would engage in unethical behavior. Furthermore in the 
CY 2019 HH PPS final rule with comment period (83 FR 56455), we 
provided detailed explanation as to why we believe that targeted 
actions against specific providers who may or may not be engaging in 
abusive coding patterns would not be effective. Explicitly, we stated 
that system-wide case-mix levels have risen over time throughout the 
country, while patient characteristics data indicate little real change 
in patient severity over that same time. These widespread changes make 
it challenging to clearly separate agencies into high and low coding 
change groups. While we do not believe that our overall assumptions are 
exaggerated, we also recognize commenter concern over the frequency of 
these behaviors during the first year of the payment changes.
    Finally, in the CY 2019 HH PPS final rule with comment period (83 
FR 56455), we stated that the behavior assumption adjustment is not 
meant to be punitive, rather we are required by law to make such 
assumptions when calculating the 30-day budget-neutral payment amount. 
MedPAC comments on the CY 2020 HH PPS proposed rule support the 
finalized behavior assumptions and it states that even with the 
behavior assumption adjustment, payment would still exceed estimated 
costs. MedPAC went on to state that most HHAs will be able to absorb 
the 8.01 percent adjustment.
    Comment: A few commenters asserted that such behavior assumptions 
are not applied to other settings, should not be applied to home care, 
and applying behavior assumptions absent supporting data is not sound 
payment policy. Specifically, these commenters mention that CMS, in 
issuing the Skilled Nursing Facility (SNF) model, refused to make 
assumptions about provider behavior, stating that it would ``not make 
any attempt to anticipate or predict provider reactions to the 
implementation of the proposed [payment model].''
    Response: We remind commenters that CMS is required, by statute, to 
make assumptions about behavior changes that could occur as a result of 
the implementation of the 30-day unit of payment and the PDGM when 
calculating the 30-day payment amount in a budget neutral manner for CY 
2020. Other new payment models, such as the Patient-Driven Payment 
Model for skilled nursing facilities did not have such a statutory 
requirement. In compliance with section 1895(b)(3)(A)(iv) of the Act, 
we believe that we have made reasonable assumptions about what behavior 
changes to expect with the implementation of the new home health PPS 
payment structure which are based on previous experience with the HH 
PPS, as well as other payment systems.
    Comment: A commenter stated that there is no evidence to support 
the clinical group coding assumption. This commenter referenced the 
analysis of home health improper payments in the CMS 2017 Fee-for-
Service Supplemental Improper Payment Data Report \18\ stating improper 
payments due to incorrect coding was zero dollars.
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    \18\ 2017 Medicare Fee-for-Service Supplemental Improper Payment 
Data. https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/Downloads/2017-Medicare-FFS-Improper-Payment.pdf.
---------------------------------------------------------------------------

    Response: We note that CMS uses the Comprehensive Error Rate 
Testing (CERT) Program to estimate the Medicare Fee-For-Service (FFS) 
improper payment rate. The purpose of the CERT Program is to identify 
payments that should not have been made or payments made in an 
incorrect amount. Under the CERT Program, the definition of ``incorrect 
coding'' in the context of the home health improper payments, relates 
to incorrect HIPPS codes on HH claims, meaning that medical 
documentation supports different coding than what was billed; that the 
service was performed by someone other than the billing provider; that 
the billed service was unbundled; and that a beneficiary was discharged 
to a site other than the one coded on a claim.\19\ For example, an 
improper payment is made as a result of the HIPPS code reflecting a 
therapy threshold not supported by entries in the medical record. 
Therefore, contrary to the commenter's remark, improper home health 
payments resulting from incorrect coding does not relate to diagnosis 
codes reported, rather it relates to the reported HIPPS code on home 
health claims. We note that the most common type of improper payment 
error in home health is ``insufficient documentation''. This occurs 
when: There is missing or inadequate medical records; there is a 
missing certification or recertification or some element of the 
certification or recertification is missing; there are missing or 
inadequate orders; there are inconsistent records; there is a missing 
or inadequate plan of care; or there are multiple universal errors. For 
home health, ``insufficient documentation'' often means that the home 
health certification requirements, in entirety or an element, have not 
been submitted. Therefore, the analysis regarding the home health 
improper payments is not evidence to negate the clinical coding

[[Page 60516]]

assumption. We remind commenters that our position on the coding 
behavior assumption is that we assume that HHAs will improve their 
documentation and coding behaviors to more fully account for patient 
characteristics that impact resource use.
---------------------------------------------------------------------------

    \19\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/Downloads/IntroductiontoComprehensiveErrorRateTesting.pdf.
---------------------------------------------------------------------------

    Comment: A commenter supported the comorbidity assumption and 
stated that prior to this proposal, there was no motivation to code all 
of the patient's comorbidities and that under the PDGM, HHAs will have 
the motivation to document all conditions that affect patient care. 
This commenter stated that this would be a positive change in that it 
gives a more complete picture of acuity for the patients being cared 
for by the HHA and would demonstrate that HHAs are caring for very 
complex, chronically ill patients and perhaps keeping these patients 
out of more costly care settings.
    Response: We agree with this commenter that the availability to 
report more secondary diagnoses on the home health claim would provide 
home health agencies with the opportunity to more comprehensively 
portray all of the comorbidities affecting the home health plan of 
care. We believe this will benefit HHAs in terms of receiving a payment 
adjustment to account for the services being provided to address such 
comorbidities.
    Comment: MedPAC noted that the proposed payment reduction of 8.01 
percent appears to be consistent with past trends in coding that CMS 
has reported and supported the behavioral assumptions. MedPAC also 
commented that the proposed behavior adjustment may not represent all 
of the behavioral changes that could occur. Specifically, MedPAC 
suggested that agencies could respond to the new 30-day unit of payment 
by providing additional visits after an initial 30-day period to 
trigger an additional 30-day payment, which could result in higher 
aggregate payments and that CMS should reduce payments to reflect this 
excess.
    Response: We thank MedPAC for their comments. We agree that there 
may be other behavior changes that could result from a new case-mix 
system and a change in the unit of payment, including the behavior 
MedPAC describes. However, we are not adding a prospective adjustment 
to account for this additional potential behavior change for CY 2020 as 
we believe that the behavior changes finalized in the CY 2019 final 
rule with comment period are the ones best supported based on our 
experience with changes to payment systems for home health and other 
provider types. As required by the statute, we will analyze data for 
CYs 2020 through 2026 to annually determine the impact of differences 
between assumed behavior changes and actual behavior changes on 
estimated aggregate expenditures. This means, we would examine all 
behavior changes and not just those assumed to determine their impact 
on overall expenditures. CMS, at a time and in a manner appropriate, is 
required to determine whether the 30-day payment amounts needs to be 
increased or decreased in response to actual observed behavior change. 
We interpret actual observed behavior change to encompass both behavior 
changes that were previously outlined, as assumed by CMS when 
calculating 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.
    Comment: Several commenters requested CMS provide expected total 
aggregated budget neutral HH PPS expenditures for future years and 
requested to further understand how the cases dropped from PDGM would 
be accounted for in the budget neutrality calculations. Another 
commenter stated that all existing work papers on the PDGM behavior 
adjustment by any party within CMS, including the Office of the 
Actuary, should be made readily available to the public through the CMS 
website. These comments express significant concerns that the dropped 
claims violate the Jimmo vs. Sebelius settlement agreement by excluding 
them from the analysis and not recognizing the patient needs in PDGM. 
Another commenter recommends that CMS should publish for public notice 
and comment a full description of its behavior adjustment calculation, 
including all the specific data used in the assessment along with the 
complete calculation methodology. A commenter expressed concerns that 
CMS is not considering the requirements of the Regulatory Flexibility 
Act or the Small Business Regulatory Enforcement Fairness Act, which 
limits the impact on small businesses. This commenter stated that many 
home health agencies are considered ``small business'' and should be 
afforded targeted oversight efforts rather than apply all claims to the 
behavioral assumption analysis. The commenter recommended that CMS 
consider alternatives to the behavioral adjustment that would take into 
account any oversight to prevent up coding or unnecessary utilization 
increased to offset the behavioral adjustment.
    Response: We believe that it would be difficult to accurately 
predict total aggregate budget neutral HH PPS expenditures for future 
years because we cannot anticipate future year home health rate 
updates, which vary from year to year. Furthermore, we cannot 
anticipate any future legislative action that would require a set home 
health rate update for any given year. As such, we do not believe that 
providing this type of data would produce meaningful results for 
providers' analytic purposes. However, with the proposed and this final 
rule with comment period, we released the ``Home Health Claims--OASIS'' 
Limited Data Set (LDS) file, which contains information on the 
utilization of the Medicare Home Health benefit on the CMS website.\20\ 
This LDS file is meant to support HHAs in evaluating the effects of the 
PDGM and provides detailed information for HHAs. Therefore, we believe 
that we have provided sufficient publically available information for 
HHAs to utilize so they can fully understand the effects of the PDGM.
---------------------------------------------------------------------------

    \20\ Home Health Prospective Payment System (HH PPS) Limited 
Data Set (LDS) web page. https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/Home_Health_PPS_LDS.html.
---------------------------------------------------------------------------

    We remind commenters that we did provide a detailed explanation as 
to how we calculated the behavior adjustment in the CY 2020 proposed 
rule (84 FR 34615). For this final rule with comment period, we used a 
2018 analytic file that included 6,388,974 60-day episodes ($18 billion 
in total expenditures); however 9.5 percent of claims were excluded 
because they could not be linked to an OASIS assessment, or were RAPs 
without a final claim, or they were claims with zero payment amounts. 
After these and other exclusions, the resulting 2018 analytic file 
represented 5,471,454 60-day episodes and $16.6 billion in total 
expenditures. We do not agree that these excluded claims would be 
useful for inclusion of the behavior assumption adjustment, nor do we 
see any relationship between standard data cleaning procedures and the 
Jimmo v. Sebelius settlement, which addresses Medicare coverage of 
certain types of maintenance therapy for certain Medicare providers, 
and does not reflect any behavioral analyses. Furthermore, we believe 
the PDGM captures patient characteristics more closely associated with 
complex care needs of the chronically ill as we have demonstrated in 
our analysis of the PDGM (and previously, the HHGM). We also disagree 
that this rule does not consider the requirements of the Regulatory 
Flexibility Act or the Small Business Regulatory Enforcement Fairness 
Act, which limits the impact on small

[[Page 60517]]

businesses. In fact, we are required to consider the impact of these 
policies as we do in the Regulatory Impact Analysis section of the 
proposed and final rules. Additionally, we refer commenters to Table 36 
in the CY 2020 proposed rule that shows the CY 2020 estimated HHA 
impacts by facility type and area of the country. Even with the 8.01 
percent adjustment based on assumed behavior changes, we note that 
smaller providers would have an estimated impact of a +2.1 percent 
increase in payments as a result of the PDGM and an estimated overall 
impact of +3.6 percent as a result of the proposed payment policies in 
CY 2020. Finally, as noted throughout this rule, CMS is required to 
reconcile the difference between assumed and observed behavior changes; 
that is, we are required to examine the data beginning in CY 2020 
through CY 2026 to determine the impact of the differences between 
assumed behavior changes and actual behavior changes on estimated 
aggregate expenditures to determine whether any temporary adjustments 
for retrospective behavior or any permanent adjustments on a 
prospective basis are warranted to offset such increases or decreases.
    Comment: A commenter recommended that CMS should factor the impact 
of decreased Medicare payments due to home health agency closures as 
part of the budget neutrality analysis. This commenter stated that 
evidence exists to support that a change to a new payment system will 
lead to agency closures and provided the example of the change from 
cost reimbursement payment system to the Interim Payment System and 
then to the Home Health Prospective Payment System, which resulted in a 
30 percent reduction in the number of home health agencies. The 
commenter stated that the CY 2020 PDGM Agency Level Impacts file posted 
with the CY 2020 proposed rule is misleading because it gives an 
estimated PDGM revenue that does not include the adjustment due to the 
behavioral assumptions.
    Response: We agree with commenters that there have been notable 
changes in the provision of home health services since the 1980s. 
MedPAC has provided a detailed description of the use and growth of the 
home health benefit and has shown how the benefit has varied 
substantially because of changes in coverage and payment policy in its 
reports.\21\ We remind commenters that implementation of the inpatient 
hospital PPS in 1983 led to increased use of home health services as 
hospital lengths of stay decreased. As a result, the number of home 
health agencies (HHAs), users, and services expanded rapidly in the 
early 1990s. As the rates of use and the duration of home health 
episodes increased, there was concern that the benefit was serving more 
as a long-term care benefit.\22\ The trends of the early 1990s prompted 
increased program integrity actions, refinements of coverage standards, 
temporary spending caps through an interim payment system (IPS), and 
the eventual replacement of the cost-based payment system with a 
prospective payment system in 2000. We agree that the implementation of 
the IPS resulted in a decrease in the number of HHAs. However, after 
the HH PPS was implemented, home health service use and agency supply 
rebounded at a rapid pace. Between 2001 and 2017, the number of home 
health episodes rose from 3.9 million to 6.3 million.\23\ In 2017, the 
number of HHAs was 11,844--higher than the level of supply during the 
1990s. Almost all the new agencies since implementation of the PPS have 
been for-profit providers. We also note that in the CY 2014 HH PPS 
final rule (78 FR 72282), commenters expressed similar concerns that 
HHAs would be forced to close in response to the rebasing adjustment to 
the 60-day national, standardized episode payment amount, required by 
section 3131(a) of the Patient Protection and Affordable Care Act 
(PPACA). In the CY 2014 HH PPS final rule, we finalized a 2.8 percent 
reduction to the national, standardized 60-day episode payment rate in 
each year beginning in CY 2014 through CY 2017. However, MedPAC has 
reported that even with these rebasing reductions, HHAs were able to 
adapt and there was no evidence of large-scale HHA closures or issues 
with access to care. In fact, MedPAC reported that changes in average 
payment per full episode (defined as episodes of more than four visits) 
underscored the limited impact of the PPACA rebasing policy that was 
implemented in 2014. Average payment per episode increased in the first 
three years of rebasing and the average payment per episode in 2016, 
the third year of rebasing, was 3.1 percent higher than the average 
payment per episode in 2013, before rebasing was implemented.\24\ 
Therefore, we do not believe there will be large-scale HHA closures or 
issues with access to care as a result of the implementation of the 
PDGM, given past experience of HHAs adapting to payment system changes.
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    \21\ MedPAC report, ``Home Care Services'', March 2019. https://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch9_sec.pdf?sfvrsn=0.
    \22\ Government Accountability Office. 1996. Medicare: Home 
health utilization expands while program controls deteriorate. GAO/
HEHS-96-16. Washington, DC: GAO.
    \23\ MedPAC report, ``Home Care Services'', March 2019. https://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch9_sec.pdf?sfvrsn=0.
    \24\ MedPAC Report, Home Care Services'', chapter 9, March 2018. 
https://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch9_sec.pdf?sfvrsn=0.
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    While we recognize that there can be a shift in provider practice 
patterns in response to payment changes, we believe that the PDGM puts 
patient characteristics and other pertinent clinical information at the 
forefront in adjusting home health payments to account for increases in 
resource use. We believe this is an improvement over other significant, 
past case-mix adjustment and payment changes because of the primary 
focus on patient characteristics that affect resource utilization. 
However, we are also aware that the transition to a 30-day unit of 
payment and implementation of a new case-mix system, the first 
significant payment changes to the HH PPS in almost 20 years, warrants 
modifications to HHA billing practices, software systems, and staff 
education. As we have stated since we finalized the PDGM in the CY 2019 
final rule with comment period, we will continue to monitor the 
provision of home health services, including any changes in the 
composition of the disciplines providing such services, overall home 
health payments, and any effects on HHAs to determine if any unintended 
consequences result from the change in the case-mix adjustment 
methodology and the 30-day unit of payment that may warrant refinements 
in future rulemaking.
    Comment: Most commenters expressed concern about the impact of the 
proposed 8.01 percent reduction in payment based on assumed behavior 
changes that HHAs may make in response to the change in the case-mix 
adjustment methodology and the change to a 30-day unit of payment. 
Commenters stated that this reduction would be one of the most 
significant reductions taken in any new or existing Medicare payment 
systems to date and would result in negative financial consequences, 
especially for smaller, rural HHAs that may not be able to make the 
changes necessary to adapt to the PDGM immediately upon implementation.
    Response: We note that the overall impact on the estimated 
aggregate expenditures resulting from the PDGM and the 30-day unit of 
payment is zero

[[Page 60518]]

given the statutory requirement that these changes are implemented in a 
budget-neutral manner. We appreciate commenter concerns regarding the 
impact of these assumptions on smaller and rural HHAs. We refer to 
Table 36 in the CY 2020 HH PPS proposed rule (84 FR 34706), which shows 
that the impact of the PDGM and the 30-day unit of payment (with 
behavior assumptions) on rural providers would be 3.7 percent and the 
impact on smaller providers (less than 100 episodes) would be 2.1 
percent. Therefore, we believe that rural and smaller HHAs would 
recognize an increase in overall payments under the PDGM and the 30-day 
unit of payment.
    We also remind commenters that even with the behavior assumption 
adjustment of 8.389 percent, the CY 2020 30-day payment rate of 
$1,785.51 (including the wage index standardization factor and the CY 
2020 rate update) would be approximately 11 percent higher than the 
estimated, CY 2020 30-day period cost of $1,608.82. Additionally, in 
its comments on the proposed rule, MedPAC states that the analysis of 
payments and costs in the proposed rule suggests that payments will be 
more than adequate in 2020. However, we will continue to monitor the 
effect of the payment changes, including the impacts on smaller and 
rural providers to mitigate any potential unintended consequences. 
Moreover, we are required to examine the data beginning in CY 2020 
through CY 2026 to determine the impact of the differences between 
assumed behavior changes and actual behavior changes on estimated 
aggregate expenditures to determine whether any temporary adjustments 
for retrospective behavior or any permanent adjustments on a 
prospective basis are warranted to offset such increases or decreases.
    Comment: Many commenters stated that the magnitude of the 8.01 
percent reduction to the home health 30-day payment rate has the 
potential to create negative consequences for providers transitioning 
to a new case-mix adjustment methodology and a change in the unit of 
payment. Several commenters mentioned the provider burden associated 
with other existing and new requirements, including HHVBP and the 
resumption of the Review Choice Demonstration and stated that there are 
too many changes occurring simultaneously and that many HHAs, 
especially smaller and rural providers, could not incur the costs of 
all of these changes all at once. Several commenters stated they 
recognize the statutory requirement to make such behavior assumptions 
when calculating the budget-neutral 30-day payment rate, but requested 
that CMS phase-in the behavior assumption reduction over a period of 
three years, rather than all at one time. Several commenters recognize 
the phase-out of the rural add-on is based on the Bipartisan Budget Act 
of 2018 with no latitude to revise the proposal, however, they suggest 
CMS takes this into consideration in relation to the 8.01 behavioral 
adjustment. Some commenters indicate the phase-out of the rural add-on 
payment, coupled with other payment system changes, would be difficult 
for rural HHAs to fiscally manage. Other commenters stated the 
assumption that 100 percent of providers will change coding practices 
and make such changes 100 percent of the time, without sufficient data, 
is an overestimation and suggested that reduction percentage be halved, 
as this is a more realistic assumption about the frequency of such 
behavior changes.
    Response: We appreciate commenter concerns about the potential 
impact of the behavior assumption adjustment. We recognize that 
transitioning to the first significant HH PPS payment system change in 
almost 20 years requires a considerable amount of system changes, staff 
education, and modification of current billing processes. We are also 
cognizant that there have been recent changes to the home health CoPs, 
as well as a resumption of the Review Choice Demonstration, and 
continuation of the HHVBP for some select states. We also understand 
concerns by rural HHAs as to the impact of the phase-out of the rural 
add-on payment coupled with other changes that may challenge their 
fiscal management.
    We continue to believe that the behavior assumptions are valid ones 
and supported by evidence as described in the CY 2019 final rule with 
comment period and the CY 2020 proposed rule. However, given the scale 
of the payment system changes, we agree that it might take HHAs more 
time before they fully implement the behavior assumed by CMS. As we 
noted in response to comments in the CY 2019 HH PPS final rule with 
comment (83 FR 56456), in the FY 2008 IPPS final rule, CMS estimated 
that a total adjustment of 4.8 percent would be necessary to maintain 
budget neutrality for the transition to the MS-DRGs (72 FR 47178). 
However, examining subsequent analysis of claims data for FYs 2008 and 
2009, our actuaries determined that the implementation of the MS-DRG 
system resulted in a 2.5 percent change in documentation and coding 
(about half of the estimated 4.8 percent change expected) in the first 
year of the MS-DRGs and a 5.4 percent change in documentation and 
coding in the second year of the MS-DRGs. Taking into consideration the 
example above and the transition to the new PDGM payment system in 
combination with other ongoing or new home health requirements, we 
believe it is reasonable to apply the three previously outlined 
behavior change assumptions to only half of the 30-day periods in our 
analytic file (randomly selected). Note that since payment is made for 
30-day periods, it is more accurate to apply the behavior assumptions 
to half the 30-day periods than to assume the magnitude of the 
behaviors would be halved. Therefore, taking this approach means that 
the resulting adjustment to the 30-day payment amount needed to 
maintain budget neutrality, as required by law, is an adjustment of -
4.36 percent. This means that the CY 2020 30-day budget-neutral payment 
amount will be $1,824.99 (not including the wage index standardization 
factor and the 1.5 percent home health rate update for CY 2020).
    We remind commenters that after implementation of the 30-day unit 
of payment and the PDGM, CMS is required by law to annually analyze 
data from CYs 2020-2026 to determine the impact of the difference 
between assumed behavior changes and actual behavior changes to 
determine if any temporary or permanent payment adjustments to the 30-
day payment amount are needed to offset for such increases or decreases 
in estimated aggregate expenditures. Therefore, if CMS underestimates 
the amount of the reductions to the 30-day payment rate necessary to 
offset behavior changes and maintain budget neutrality for CY 2020, 
larger adjustments to the 30-day payment amount would be required in 
the future, pursuant to section 1895(b)(3)(D) of the Act, to ensure 
budget neutrality with respect to estimated expenditures for CY 2020. 
Likewise, if CMS overestimates the reductions, we are required to make 
the appropriate payment adjustments accordingly, as described 
previously. The law also requires that any permanent or temporary 
payment adjustment would be proposed through rulemaking. We will review 
data from CY 2020 to inform next year's rulemaking to determine if any 
change to the behavior assumption adjustment percentage should be 
proposed in CY 2021 (for example, if the full 8.389 percent reduction 
should be proposed in CY 2021 based on actual, observed data from CY 
2020). While we are applying all three assumptions for establishing a 
30-day payment rate, we are changing our assumption regarding

[[Page 60519]]

the frequency with which those behaviors would occur in the first year 
of implementation.
    Final Decision: Based on the comments received and reconsideration 
as to frequency of the assumed behaviors during the first year of the 
transition to a new unit of payment and case-mix adjustment 
methodology, we are finalizing a -4.36 percent behavior change 
assumptions adjustment in order to calculate the 30-day payment rate in 
a budget-neutral manner for CY 2020. This adjustment will be made using 
the three behavior assumptions finalized in the CY 2019 HH PPS final 
rule with comment period (83 FR 56461).
    The finalized 30-day budget-neutral payment amount with the -4.36 
percent behavioral assumption adjustment will be $1,824.99 and the CY 
2020 30-day payment rate, with the wage-index budget neutrality factor 
and the home health payment update of 1.5 percent, will be $1,864.03 
with a fixed-dollar loss ratio of 0.56. Section III.E. of this final 
rule with comment period describes the CY 2020 home health payment rate 
update and section III.F. describes the payments for high-cost outliers 
and the fixed-dollar loss ratio for the CY 2020 HH PPS.
    Finally, we also wish to remind stakeholders again that CMS will 
provide, upon request, a Home Health Claims-OASIS LDS file to accompany 
the CY 2020 final rule with comment period 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 CMS Limited 
Data Set (LDS) Files website. Additionally, we have posted the CY 2020 
provider-level impacts and an updated Interactive Grouper Tool on the 
HHA Center web page and the PDGM web page 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.\25\
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    \25\ Home Health Agency (HHA) Center web page. https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html.
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C. 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. 
The CY 2020 HH PPS proposed rule (84 FR 34617), outlined the 
implementation of the PDGM and a change in the unit of home health 
payment to 30-day periods of care. As such, we are recalibrating the CY 
2020 case-mix weights for 30-day periods of care using the PDGM 
methodology. 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. We did not 
propose to separately recalibrate the case-mix weights for those 60-day 
episodes that span the January 1, 2020 implementation date, rather we 
proposed, that these 60-day episodes would be paid the national, 
standardized 60-day episode payment amount and would be case-mix 
adjusted using the CY 2019 case-mix weights as listed in Table 6 in the 
CY 2019 HH PPS final rule with comment period (83 FR 56422) and posted 
on the HHA Center web page. With the implementation of a new case-mix 
adjustment methodology and a move to a 30-day unit of payment, we 
believe this approach will 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 proposed 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 solicited comments on the proposed payment for 60-day episodes 
of care that span the January 1, 2020 implementation date of the PDGM 
and the change to a 30-day unit of payment. We received a comment from 
an industry association and this comment and our response is summarized 
in this section of this final rule with comment period.
    Comment: A commenter did not agree with our proposal to not 
recalculate the of case-mix weights for 60-day episodes that span 
implementation of the PDGM and the change to a 30-day unit of payment 
given that the national, standardized 60-day episode payment rate is 
being updated for CY 2020. This commenter stated that all variables 
that affect payment in CY 2020 should be updated for 2020.
    Response: We note that we are recalibrating the case-mix weights 
for 30-day periods of care beginning in CY 2020 in accordance with our 
policy to annually recalibrate the HH PPS case-mix weights. We note 
that any recalibration to the case-mix weights for those 60-day 
episodes that span the January 1, 2020 implementation date of the new 
case-mix system and the change to a 30-day unit of payment would be 
very similar to the CY 2019 case-mix weights. We remind commenters that 
we did propose to update the national, standardized 60-day episode 
payment amount for CY 2020, which does result in an increased base rate 
for these episodes of care. We continue to believe that this approach 
to the case-mix weights for those 60-day episodes that span into CY 
2020 is less burdensome for HHAs who are transitioning to a new case-
mix methodology and a 30-day unit of payment.
    Final Decision: We are finalizing as proposed that 60-day episodes 
spanning the January 1, 2020 implementation date of the PDGM and the 
change to a 30-day unit of payment will be paid the CY 2020 national, 
standardized 60-day episode payment amount of $3,220.79 (see Table 17), 
and will be case-mix adjusted using the CY 2019 case-mix weights as 
listed in the CY 2019 HH PPS final rule with comment period (83 FR 
56422) and posted on the HHA Center web page.\26\ Additionally, for 
those 60-day episodes that end after January 1, 2020, but where there 
is a continued need for home health services, any subsequent periods of 
care will be paid the CY 2020 national, standardized 30-day period 
payment amount (as shown in section III.E of this final rule with 
comment period) with the appropriate CY 2020 PDGM case-mix weight 
applied.
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    \26\ Home Health Agency web page. https://www.cms.gov/center/
provider-Type/home-Health-Agency-HHA-Center.html.
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D. CY 2020 PDGM Low-Utilization Payment Adjustment (LUPA) Thresholds 
and PDGM Case-Mix Weights

1. 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

[[Page 60520]]

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 with comment period (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 July 31, 2019) linked to OASIS 
assessment data for this rule. The 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 16. 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.
2. 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 with comment period (83 FR 56502), the 
PDGM places patients into meaningful payment categories based on 
patient characteristics (principal diagnosis, functional level, 
comorbid conditions, admission source and timing). The PDGM case-mix 
methodology results in 432 unique case-mix groups called Home Health 
Resource Groups (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 July 31, 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 final rule with comment period:
    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 15 shows the coefficients 
of the payment regression used to generate the weights, and the

[[Page 60521]]

coefficients divided by average resource use.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR08NO19.021

BILLING CODE 4120-01-C

[[Page 60522]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.022

    Table 16 presents the HIPPS code, the LUPA threshold, and the case-
mix weight for each Home Health Resource Group (HHRG) in the regression 
model for CY 2020.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR08NO19.023


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[GRAPHIC] [TIFF OMITTED] TR08NO19.034

BILLING CODE 4120-01-C
    The following is a summary of the comments received and our 
responses to comments on the CY 2020 PDGM LUPA Thresholds and PDGM 
Case-Mix Weights.
    Comment: A few commenters stated that the case mix weights for 
clinical groups that include therapy services are significantly 
depressed from the weights that would be assigned if CMS continued to 
use BLS data. These commenters expressed concern that there is a 
reduction in payment rates for therapy clinical groups and this would 
create barriers to care for patients needing therapy. These commenters 
urged CMS to continue to use BLS data for determining the PDGM case-mix 
weights.
    Response: We finalized the CPM+NRS approach to calculating the 
costs of care in the CY 2019 HH PPS final rule with comment period and 
in that rule we stated that we believe that the use of HHA Medicare 
cost reports better reflects changes in utilization, provider payments, 
and supply amongst Medicare-certified HHAs that occur over time. Under 
a Wage-Weighted Minutes of Care (WWMC) approach, using the BLS average 
hourly wage rates for the entire home health care service industry does 
not reflect changes in Medicare home health utilization that impact 
costs, such as the allocation of overhead costs when Medicare home 
health visit patterns change. Using data from HHA Medicare cost reports 
better represents the total costs incurred during a 30-day period 
(including, but not limited to, direct patient care contract labor, 
overhead, and transportation costs), while the WWMC method provides an 
estimate of only the labor costs (wage and fringe benefit costs) 
related to direct patient care from patient visits that are incurred 
during a 30-day period. We will recalibrate the case-mix weights 
annually, as is currently done, to ensure that the case-mix weights 
accurately align with the cost of providing care.
    Comment: A commenter recognized the long-term improvement of the 
LUPA proposal to align low acuity episodes with a lower LUPA threshold 
while high-acuity episodes would have higher LUPA threshold. A few 
commenters stated that the LUPA thresholds are confusing and 
recommended a more straightforward approach to pay for LUPAs. Another 
commenter remarked that there were some institutional admission source 
LUPA thresholds that had less number of visits to meet the threshold 
than their community admission source counterparts and questioned if 
this was accurate. This commenter also stated that other institutional 
admission source thresholds were only one visit more than their 
community admission source counterpart and that this seems incorrect if 
institutional admission sources have higher resource costs than 
community admission sources.
    Response: Because of the change in the unit of payment from a 60-
day episode to a 30-day period, the approach to calculating the LUPA 
thresholds needed to change in order to target approximately the same 
percentage of LUPAs. As we discussed in both the CYs 2018 and 2019 HH 
PPS proposed rules, 30-day periods of care have substantially more 
episodes with four or fewer visits than 60-day episodes. To create LUPA 
thresholds for 30-day periods of care, we finalized in the CY 2019 
final rule with comment period to set the LUPA threshold at the 10th 
percentile value of visits or 2, whichever is higher, for each payment 
group, in order to target approximately the same percentage of LUPAs 
(approximately 7.1 percent of 30-day periods would be LUPAs (assuming 
no behavior change)) (83 FR 56492). We note that under the current HH 
PPS, LUPA episodes are billed the same as a non-LUPA episodes and this 
will not change under the PDGM where LUPA periods of care will be 
billed the same way as non-LUPA 30-day periods of care; therefore, we 
do not believe that this would cause any confusion related to billing.
    The commenter is correct that there are some institutional 
admission source LUPA thresholds that are less than their community 
counterparts. The LUPA threshold does not necessarily relate to the 
case-mix weight of the 30-day period. For example, looking at the case-
mix group, Behavioral Health--Low Functional Impairment, Early Timing, 
Low Comorbidity Adjustment:
     Community 30-day periods have an average resource use of 
$1,655.70 and a LUPA threshold of 4 visits.
     Institutional 30-day periods have average resource use of 
$1,804.17 and a LUPA threshold of 3 visits.
    We remind commenters that we finalized the policy for the PDGM LUPA 
thresholds to target approximately the same percentage of LUPAs as 
under the 153 case-mix weight system using the criteria noted 
previously. We continue to believe that the LUPA thresholds that vary 
based on the case-mix assignment for the 30-day period of care in the 
proposed PDGM is an improvement over the current 5 visit threshold that 
does not vary by case-mix assignment. Likewise, in the CY 2019 HH PPS 
final rule with comment period (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.

[[Page 60534]]

    Final Decision: We are maintaining our finalized policy in the CY 
2019 HH PPS final rule with comment period (83 FR 56492) to vary the 
LUPA thresholds for each 30-day period of care depending on the PDGM 
payment group to which it is assigned. Additionally, we are finalizing 
the CY 2020 LUPA thresholds and case-mix weights as shown in Table 16 
in this final rule with comment period. We will continue to update the 
LUPA thresholds by payment group and will annually recalibrate the 
case-mix weights using the most current data available at the time of 
rulemaking.

E. CY 2020 Home Health Payment Rate Updates

1. 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 with comment period (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 with comment period (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 https://www.bls.gov/mfp, to 
obtain the BLS historical published MFP data.
    The 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 2.9 percent (based on IHS Global 
Insight Inc.'s third-quarter 2019 forecast). However, 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 2.9 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 0.3 percentage point for CY 2020. In effect, 
the 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 will 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 proposed 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 proposed 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 proposed 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 proposed to use the average wage index from all 
contiguous Core Based Statistical Areas (CBSAs) as a reasonable proxy. 
Currently, the only 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 proposed 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 only urban area without inpatient hospital wage data is 
Hinesville, GA (CBSA 25980). The CY 2020 wage index value for 
Hinesville, GA is 0.8322.
    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

[[Page 60535]]

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 0.8291. The August 15, 2017 Bulletin 
No. 17-01, Revised Delineations of Metropolitan Statistical Areas, 
Micropolitan Statistical Areas, and Combined Statistical Areas, and 
Guidance on Uses of the Delineations of These Areas, is available at 
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.
    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 Home Health 
Prospective Payment System Regulations and Notices web page: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
    We received 1 comment regarding the CY 2020 Home Health wage index. 
The comment and our response appear in this section of this final rule 
with comment period:
    Comment: A commenter questioned the validity of the CY 2020 wage 
index data in the case of the CBSA for Albany-Schenectady-Troy, noting 
that in the past 6 years, this CBSA has seen its wage index reduced 
5.17 percent, going from 0.8647 in 2013 to a proposed CY 2020 wage 
index of 0.820. This commenter also suggests that the Albany-
Schenectady-Troy CBSA should not be lower than any of the following 
other upstate New York CBSAs: Binghamton, Elmira, Glen Falls, 
Rochester, Syracuse, Watertown-Fort Drum and, most significantly, the 
``New York Rural Areas CBSA,'' which is proposed to be 0.8431.
    Response: As discussed in the CY 2017 HH PPS final rule (81 FR 
76721), we believe that the wage index values are reflective of the 
labor costs in each geographic area as they reflect the costs included 
on the cost reports of hospitals in those specific labor market areas. 
The area wage index measures differences in hospital wage rates among 
labor market areas and compares the area wage index of the labor market 
area to the national average hourly wage. If a hospital or labor market 
area does not keep pace with the national average hourly wage in a 
given year, then the labor market area will see a decrease in the area 
wage index during that year.
    We utilize efficient means to ensure and review the accuracy of the 
hospital cost report data and resulting wage index. Hospitals must 
complete the wage index survey (Worksheet S-3, Parts II and III) as 
part of their Medicare cost reports. Cost reports will be rejected if 
Worksheet S-3 is not completed. Medicare contractors perform desk 
reviews on all hospitals' Worksheet S- 3 wage data, and we run edits on 
the wage data to further ensure the accuracy and validity of the wage 
data. If any provider believes the underlying hospital wage data is 
inaccurate, the data would have to be corrected by the Medicare 
Administrative Contractor (MAC) within the necessary timeframe in order 
for the error to be corrected; otherwise the data would be deemed final 
for that upcoming year's wage index. The time table used for the 
development of the FY 2020 hospital wage index can be found at the 
following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Downloads/FY2020-Hospital-Wage-Index-Development-Time-Table.pdf. We believe that our review processes result 
in an accurate reflection of the applicable wages for the areas given.
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 solicited 
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.
    The following is a summary of the comments received on the proposed 
CY 2020 home health wage index comment solicitation, and our responses:
    Comment: A few commenters recommended that the wage index account 
for areas with higher minimum wage standards. A commenter stated that 
the pre-floor, pre-reclassified hospital wage index is ``wholly 
inadequate for adjusting home health costs, particularly in states like 
New York which has among the nation's highest labor costs now greatly 
exacerbated by the states implementation of a phased in $15 per hour 
minimum wage hike, the balance of which is unfunded by Medicare.'' 
Another commenter suggested that CMS develop a reimbursement system 
adjustment providing supplemental funding to providers, such as HHAs, 
required to meet higher minimum wage standards, better to align 
reimbursement rates with cost trends impacting these providers.
    Response: Regarding minimum wage standards, we note that such 
increases would be reflected in future data used to create the hospital 
wage index to the extent that these changes to state minimum wage 
standards are reflected in increased wages to hospital staff.
    Comment: Several commenters recommended that CMS consider 
consulting with home health agencies to develop a home health specific 
wage index or explore opportunities to improve the wage index applied 
to home health. A commenter urges CMS to consider a home health 
specific wage index to support staff retention due to increased demands 
on meeting paperwork and regulatory requirements. The commenter notes 
that the current home health wage index is tied to hospital wage data, 
which does not reflect the true cost of hiring and retaining high 
quality home health staff. Another commenter suggested that CMS use 
home health specific data contained in home health cost reports, which 
contain average cost per visit. A commenter recommended that CMS use 
the post-reclassified wage index values for each CBSA. Another 
commenter indicated that ``CMS should include wage data from 
reclassified hospitals in calculating the rural wage index for home 
health agencies.'' The same commenter indicated that CMS should examine 
how population density impacts home health agency costs and then adjust 
the wage index by multiplying by a population density factor so that 
areas with a lower population density have a higher adjusted wage 
index. A few commenters indicated that an approach similar to that used 
in the FY 2020 Inpatient Hospital PPS final rule should be used, where 
hospitals with a wage index value that was less than the 25th 
percentile had their wage index increased. A commenter also suggested 
that a wage index floor should be established similar to the 0.8 
hospice wage index floor.
    Response: We thank the commenters for their comments. We will 
consider these recommendations for future rulemaking.
    Final Decision: After considering the comments received in response 
to the CY 2020 HH PPS proposed rule, we are finalizing our proposal to 
continue to use the pre-floor, pre-reclassified

[[Page 60536]]

hospital inpatient wage index as the wage adjustment to the labor 
portion of the HH PPS rates. For CY 2020, the updated wage data are for 
the hospital cost reporting periods beginning on or after October 1, 
2015 and before October 1, 2016 (FY 2016 cost report data). The final 
CY 2020 wage index is available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
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 
with comment period (83 FR 56406) and as described in section III.B of 
this 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 after January 
1, 2020. As such, the latest date such a 60-day crossover episode could 
end on is February 28, 2020. Those 60-day crossover 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 17.
    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 with comment period (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 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 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.G. of this 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) 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.E. of this 
rule. We did not propose to update the case-mix weights for the 153-
group case-mix methodology in CY 2020 as outlined in section III.D. of 
this rule. Because we will use the CY 2019 case-mix weights, we do not 
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 final 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 1.0060. We apply the wage 
index budget neutrality factor of 1.0060 to the calculation of the CY 
2020 national, standardized 60-day episode payment rate.
    Next, we 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 rule. 
The CY 2020 national, standardized 60-day episode payment rate is 
calculated in Table 17.

[[Page 60537]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.035

    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 18.
[GRAPHIC] [TIFF OMITTED] TR08NO19.036

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 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 NRS conversion factor for CY 2020 is shown in Table 19.
[GRAPHIC] [TIFF OMITTED] TR08NO19.037

    Using the CY 2020 NRS conversion factor, the payment amounts for 
the six severity levels are shown in Table 20.

[[Page 60538]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.038

    For HHAs that do not submit the required quality data, we updated 
the CY 2019 NRS conversion factor ($54.20) by the CY 2020 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 CY 2020 NRS conversion 
factor for HHAs that do not submit quality data is shown in Table 21.
[GRAPHIC] [TIFF OMITTED] TR08NO19.039

    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 22.
[GRAPHIC] [TIFF OMITTED] TR08NO19.040

    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 in CY 2020, on or before 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. of this final rule with comment period.
    To calculate the wage index budget neutrality factor, we simulated 
total payments for non-LUPA 30-day periods

[[Page 60539]]

using the final CY 2020 wage index and compared it to our simulation of 
total payments for non-LUPA 30-day periods using the CY 2019 wage 
index. By dividing the total payments for non-LUPA 30-day periods using 
the CY 2020 wage index by the total payments for non-LUPA 30-day 
periods using the CY 2019 wage index, we obtain a wage index budget 
neutrality factor of 1.0063. We would apply the wage index budget 
neutrality factor of 1.0063 to the calculation of the CY 2020 national, 
standardized 30-day period payment rate as described in section III.B. 
of this 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, a case-mix 
budget neutrality factor is not applicable. 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 estimated change 
in aggregate payments between the previous year's PDGM case-mix weights 
and the recalibrated PDGM case-mix weights.
    Next, we 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.E. of this final 
rule with comment period. The CY 2020 national, standardized 30-day 
period payment rate is calculated in Table 23.
[GRAPHIC] [TIFF OMITTED] TR08NO19.041

    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 24.
[GRAPHIC] [TIFF OMITTED] TR08NO19.042

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 weight 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 25.

[[Page 60540]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.043

    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 26.
[GRAPHIC] [TIFF OMITTED] TR08NO19.044

    Final Decision: We did not receive any comments on the CY 2020 home 
health payment rate update for CY 2020. Therefore, we are finalizing 
the 60-day episode payment rates for those episodes of care that span 
the January 1, 2020 implementation date of the change to a 30-day unit 
of payment; the 30-day period payment rates for periods of care 
beginning on and after January 1, 2020; the CY 2020 per-visit payment 
rates; and the home health update percentage to update the home health 
payment rates for CY 2020 as proposed.
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

[[Page 60541]]

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 with comment period (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 
associated with the publication of this rule is available in the 
``Downloads'' section of the Home Health Prospective Payment System 
Regulations and Notices web page. 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 on the same web page.
    The HH PRICER module, located within CMS' claims processing system, 
will increase the final CY 2020 60-day and 30-day base payment rates 
described in section III.E. of this 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 27.
[GRAPHIC] [TIFF OMITTED] TR08NO19.103

    While we did not solicit comments on the rural add-on percentages 
as these are mandated by the BBA of 2018, we did receive a few 
comments, mainly from rural HHAs. These are summarized in this section 
of this final rule with comment period.
    Comment: MedPAC supports CMS's proposal that recognizes high-
utilization counties, low-population counties, and all other counties 
to apply to rural add-on to remain in effect until CY 2022. MedPAC has 
not found systematic issues with access to home health care in rural 
areas nor concerns regarding rural home health margins. Furthermore, 
CMS's rural add-on policy supports MedPAC's recommendation to target 
rural payment adjustments to areas that have access challenges.
    Response: We thank MedPAC for their support.
    Comment: Several commenters recognized that the phase-out of the 
rural add-on is based on the Bipartisan Budget Act of 2018 with no 
latitude to revise the proposal. However, they suggested CMS take this 
into consideration in relation to the 8.01 percent reduction in the 
standardized 30-day rate to account for behavioral adjustments. Some 
commenters indicate the phase-out of the rural add-on payment, coupled 
with other payment system changes, would be difficult for rural HHAs to 
fiscally manage. Commenters indicated that CMS should monitor the 
impact of the phase-out (and determine if counties experience 
demographic changes year to year) and publicly report findings. A 
commenter recommended continued monitoring during the PDGM post-
implementation period in order to determine the impact on accessibility 
to care and the ability of providers to fill open staffing positions.
    Response: We understand commenter concerns about a phase-out of 
rural add-on payments and potential effects on rural HHAs. However, 
because the current rural add-on policy is statutory, we have no 
regulatory discretion to extend it. Congress would need to change the 
law. Additionally, section 1895(b)(3)(A)(iv) of the Act requires that 
in calculating a 30-day payment amount in a budget-neutral manner, the 
Secretary must make assumptions about behavior changes that could occur 
as a result of the implementation of the 30-day unit of payment and the 
new case-mix adjustment methodology. We remind commenters that the 
overall impact of the PDGM, the 30-day unit of payment, and behavioral 
assumptions is zero given the statutory requirement that these changes 
are implemented in a budget-neutral manner. CMS will continue to 
monitor patient access to home health services, as well as the costs 
associated with providing home health care in rural versus urban areas, 
and the impacts due to policy changes, including the changes in rural 
add-on payments for CYs 2019 through 2022. We will provide the industry 
with periodic updates on our analysis in rulemaking and/or 
announcements on the HHA Center web page at: https://www.cms.gov/
Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
    Comment: Several commenters indicated that CMS should continue to 
ensure beneficiaries living in rural areas have adequate access to the 
home health benefit. Some commenters indicated

[[Page 60542]]

that CMS should consider providing coverage for telehealth services 
related to therapy.
    Response: We thank commenters for their suggestions as it relates 
to telehealth services. Section 1895(e)(1)(A) of the Act prohibits 
payment for services furnished via a telecommunications system if such 
services substitute for in person home health services ordered as part 
of a plan of care certified by a physician. Thus, virtual home health 
visits would not qualify for payment under the home health benefit. We 
will continue to examine the role of telehealth under the home health 
benefit and will consider ways to more broadly support such technology 
as a part of the home health benefit when used to augment the plan of 
care, but not replace in-person visits.
    Final Decision: Policies for the provision of rural add-on payments 
for CY 2019 through CY 2022 were finalized in the CY 2019 HH PPS final 
rule with comment period (83 FR 56443), in accordance with section 
50208 of the BBA of 2018. The data used to categorize each county or 
equivalent area are 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 CY 2020 through 2022 rural add-on 
percentages outlined in law are shown in Table 27.
    We are not making any changes to the policies previously finalized 
in last year's rulemaking in this final rule with comment period.
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 with comment (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 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 $276.17 (1.8451 
multiplied by $149.68), subject to area wage adjustment.
    Also in the CY 2019 HH PPS final rule with comment period (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.
    Final Decision: We did not receive any comments on the LUPA add-on 
factors or partial payment adjustments. Therefore, as finalized in the 
CY 2019 final rule with comment period, we will continue 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. We will also retain the current PEP policy and apply such policy 
to 30-day periods of care under the PDGM.

F. Payments for High-Cost Outliers Under the HH 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

[[Page 60543]]

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 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.
    Tables 25 and 26 show the CY 2020 per-visit payment rates and we 
will 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 with comment period. 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 with comment period (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. 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 with comment period (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 did not 
propose to update the FDL ratio for those 60-day episodes that span the 
implementation date of the PDGM and the change to a 30-day unit of 
payment. For those 30-day periods of care in CY 2020, we proposed that 
the FDL ratio would need to be set at 0.63 in order for outlier 
payments not to exceed 2.5 percent of the total payments estimated to 
be made under the HH PPS. In this final rule with comment period, we 
updated the outlier estimates for 30-day periods of care beginning on 
and after January 1, 2020 using updated claims data and the final CY 
2020 payment rates outlined in section III.E.4 of this final rule with 
comment period. 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, the FDL ratio for 30-day periods of care in CY 
2020 would need to be set at 0.56 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 we updated 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 
July 31, 2019) and

[[Page 60544]]

therefore, the final FDL ratio has been updated accordingly.
    Final Decision: We did not receive any comments on the proposed FDL 
ratios for 60-day episodes of care that span the January 1, 2020 
implementation date of the PDGM and the change to a 30-day unit of 
payment or for 30-day periods of care. Therefore, we are finalizing the 
FDL ratio of 0.51 for 60-day episodes and 0.56 for 30-day periods of 
care for CY 2020.

G. Changes to the Split-Percentage Payment Approach for HHAs in CY 2020 
and Subsequent Years

    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 of 
care 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 in the common working file (CWF) so that the claims 
processing system can reject claims from providers or suppliers other 
than the primary HHA for the services and items subject to consolidated 
billing. As noted previously, section 1895(b)(2)(B) of the Act, as 
added by section 51001(a) of the BBA of 2018, requires a change in the 
unit of payment from a 60 days to 30 days, effective January 1, 2020. 
As such, in the CY 2019 HH PPS proposed rule (83 FR 32391) and in this 
year's CY 2020 HH PPS proposed rule (84 FR 34598), we discussed our 
belief that the split percentage approach to payment may no longer be 
needed for HHAs to maintain adequate cash flow.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56628), 
we discussed the typical RAP fraud scenario where an HHA enrolls in 
Medicare and proceeds to submit a large amount of RAPs in a short 
timeframe, the provider never submits a final claim and then shuts down 
the business before CMS is able to take action. In light of the 
potential for this type of fraud scenario, and the move to a 30-day 
unit of payment where HHAs can submit the final claim after 30 days, 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.
    In the CY 2020 HH PPS proposed rule (84 FR 34598), we described 
more recent fraud schemes with existing providers where individuals or 
groups with the intent of perpetuating fraud enter the program by 
acquiring existing HHAs which allows them to circumvent Medicare's 
screening and enrollment process. These individuals and groups purchase 
existing agencies through Changes of Ownerships (CHOWs) and Changes of 
Information, but fail to disclose ownership changes to CMS as required 
by 42 CFR 424.516(e) and 489.18 (as applicable). If CMS identifies the 
failure to report, it can revoke the enrollment of the HHA in the 
Medicare program under 42 CFR 424.535(a)(1) (or under 42 CFR 
424.535(a)(9) after the FY 2020 Program Integrity Enhancements to the 
Provider Enrollment Process final rule with comment period (84 FR 
47794) is effective on November 4, 2019). However, problematic 
individuals or groups that engage in the above intentional reporting 
failures may not always be identified and, thus, CMS may not be able to 
remove the bad actors from the program in all relevant cases.
    A situation like this, where an individual or group acquires 
existing HHAs and does not appropriately disclose ownership 
relationships to CMS, allows the individual or groups who have acquired 
the HHA to evade the normal enrollment screening processes enabling 
them to operate as if they are an existing provider. Situations like 
this leave CMS blind to the potentially problematic criminal history of 
the acquiring individual.
    In order to address program integrity vulnerabilities for 
situations like this, as well as those where providers enroll and flood 
the system with RAPs solely to collect the upfront payment and never 
submit a final claim, we proposed in the CY 2020 HH PPS proposed rule 
(84 FR 34598) to lower the upfront split percentage payment from the 
current 60/50 percent (depending on whether period of care is the 
initial or subsequent period) to 20 percent in CY 2020 for both initial 
and subsequent 30-day periods of care and proposed to eliminate RAPs 
for all providers starting in CY 2021. Also, after the sunset of the 
RAP policy in CY 2021, we proposed to require all HHAs to submit a one-
time NOA, within 5 calendar days from the start of care date, to 
establish that the beneficiary is under a Medicare home health period 
of care and also to trigger home health consolidated billing edits 
required under section 1842(b)(6)(F) of the Act. Moreover, we proposed 
that failure to submit a timely NOA, that is not submitting the NOA 
within 5 calendar days from the start of care date, would result in a 
reduction to the 30-day Medicare payment amount. We proposed that 
Medicare would not pay for days of home health services from the start 
of care date to the NOA filing date if the NOA was submitted after the 
5 calendar day deadline. Likewise, we proposed 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 also proposed that if an exceptional 
circumstance is experienced by the HHA, CMS may waive the consequences 
of failure to submit a timely-filed NOA. Lastly, we proposed 
corresponding regulation text changes at Sec.  484.205.
    The following is a summary of the public comments received on the 
``Split Percentage Payment Approach for a 30-day Unit of Payment'' and 
the ``Notice of Admission'' proposals and our responses:
    Comment: Most commenters did not support the phase-out of the split 
percentage payment and suggested that CMS not change its current 
policy. Other commenters stated that CMS was implementing too many 
policy changes at once and requested additional time for 
implementation. Some commenters remarked that RAPs should continue 
under the PDGM to ensure there is no disruption in cash flow for 
providers as that would be harmful to their business. Other commenters 
stated that a split percentage payment phase-out should be postponed 
for HHAs in states that require Review Choice Demonstration (RCD) 
participation. There was also some commenter support to phase-out the 
split percentage payment over a multi-year period, starting at least 
one year after the implementation of the PDGM, in order to allow 
agencies of

[[Page 60545]]

various sizes and geographical designations to appropriately adapt to 
PDGM.
    Response: We continue to believe that as a result of the change in 
the unit of payment from a 60-day episode of care to a 30-day period of 
care, that a split percentage approach to payment may not be needed for 
HHAs to maintain an adequate cash flow. With monthly billing, HHAs have 
the ability to receive ongoing cash flow which we believe would 
mitigate concerns over having adequate funds for the provision of care, 
no matter the size or geographical designation of the HHA. We note that 
for the first year of the PDGM in CY 2020, providers will still receive 
a RAP payment of 20 percent which should help transition existing 
providers to the new payment system. We also believe that the eventual 
phase-out of RAPs will significantly streamline claims processing for 
HHAs as they would not be submitting a RAP for each 30-day period of 
care and instead would submit a one-time NOA. Also, HHAs have 
capitalization requirements which requires the agency to have available 
sufficient funds at the time of applying for enrollment in Medicare, at 
all times during the enrollment process, and during the 3-month period 
following the conveyance of Medicare billing privileges to the HHA. A 
multi-year phase-out approach, which some commenters suggest, would not 
help streamline claims processing for providers nor would it address 
the ongoing program integrity issues that we have discussed in the CY 
2019 HH PPS proposed and final rules (83 FR 32391 and 83 FR 56462, 
respectively) and in this year's CY 2020 HH PPS proposed rule (84 FR 
34638). A multi-year approach would just continue to subject the 
Medicare Trust Fund to additional fraud schemes in relation to the 
submission of RAPs. However, we will continue to monitor HHA adaptation 
for the split percentage phase-out with the implementation of the PDGM, 
and may decide whether additional adjustments are necessary in future 
rulemaking if an access to care issue arises.
    Comment: Many commenters had concerns that CMS was modifying its 
RAP policy due to abuse by certain agencies. Commenters suggested that 
CMS should utilize their ability to restrict RAPs for agencies that 
abuse it instead of modifying the current RAP policy. Other commenters 
stated that because CMS recoups the majority of RAP overpayments, RAP 
policy changes were unneeded. Some commenters indicated that not all 
cases where a final claim is not submitted after a RAP are abusive and 
that CMS should address actual abuse using tools such as post payment 
review and audits. Commenters encouraged CMS to identify the agencies 
that are abusing the system and to impose more oversight through 
accrediting organizations and the MACs. A commenter raised their 
concern that removal of RAPs would increase incidents of ``cherry 
picking.''
    Response: While one of the reasons for the elimination of RAPs is 
to potentially stem program integrity vulnerabilities, it is not the 
sole reason. We remind commenters that the current median length of 
days for RAP submission is 12 days from the start of the 60-day episode 
of care. With a change in the unit of payment to a 30-day period of 
care, if this median length of days for RAP submissions remains 
constant, there is the possibility that HHAs could be simultaneously 
submitting a RAP and a final claim for each 30-day period of care. We 
believe that this defeats the purpose of the RAP to maintain adequate 
cash flow and only increases complexity for HHAs in their claims 
processing. With monthly billing, HHAs have the ability to receive an 
ongoing cash flow which we believe would mitigate concerns over having 
adequate funds for the provision of care.
    CMS's use of post payment audit and review as a means to address 
abuse is not an appropriate intervention to prevent fraudulent or 
improper behavior because these are ``pay and chase'' solutions to a 
problem that demands preventive action. Post payment review and other 
auditing approaches are not always cost effective and as described in 
the proposed rule, they, by definition, are susceptible to significant 
program integrity abuses. We are moving beyond the pay and chase 
approach to program integrity structural changes wherever possible for 
all provider settings. To base our approach to home health program 
integrity on a pay and chase framework simply does not achieve the 
protections we need to have in place. Post payment audits and other 
post payment recoupment processes are not an acceptable modern 
technological solution for ensuring proper payment in the home health 
environment.
    We acknowledge and appreciate the concerns commenters have raised 
with regards to abuse of the RAP policy by certain HHAs. We plan to 
continue to closely monitor RAP submissions, service utilization, 
payment, and quality trends which may change as a result of 
implementing of the PDGM and a 30-day unit of payment. If changes in 
practice and/or coding patterns or RAPs submissions arise, we may take 
further action, which may include administrative action against 
providers as appropriate and/or proposing changes in policy. We will 
also continue to work with the HHS Office of Inspector General as cases 
of potential provider fraud and abuse are identified.
    Comment: A commenter requests CMS to clarify or identify the 
responsible party in a change of ownership (CHOW) when the RAP is 
eliminated. Another commenter stated their belief that agencies 
submitting RAPs would not have a limitless supply of cash and provided 
questions that, when answered, would pierce corporate protections and 
allow for civil prosecution.
    Response: A change in ownership of a HHA does not change the RAP 
requirements. All home health agencies, including those that have 
undergone a change in ownership, will be subject to the elimination of 
RAPs when it occurs in CY 2022. Also, we believe that the new RAP 
policy does nothing to change any corporate protections or the rules 
regarding civil prosecution that exist currently.
    The need for regulatory change to phase-out RAPs for existing 
providers is well supported by the spike in RAP fraud schemes 
perpetrated by existing providers. As discussed in the CY 2020 HH PPS 
proposed rule (84 FR 34598), 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 the Provider 
Enrollment, Chain and Ownership System (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 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

[[Page 60546]]

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, and the provider 
subsequently submitted a spike in RAP suppressions. All payments to the 
provider were suspended. Notwithstanding, the provider was paid $3.6 
million in RAPs.
    Although CMS has attempted to address these vulnerabilities through 
extensive monitoring, audits and investigations, there continue to be 
cases of individual HHAs causing large RAP fraud losses. Recently, a 
September 27, 2019 DOJ press release highlighted a number of charges 
brought against individuals involved in certain health care fraud 
schemes: https://www.justice.gov/opa/pr/midwest-health-care-fraud-law-enforcement-action-results-charges-against-53-individuals. We consider 
these fraudulent improper payments a significant vulnerability to the 
Medicare Trust Funds. We continue to believe that we need proactive 
interventions and approaches to prevent these kinds of events from 
happening, and that the financial impact to HHAs will be minimal under 
the change from a 60-day to 30-day episode of care. Likewise, we 
believe that the RAP phase-out and eventual elimination of split-
percentage payments would serve to mitigate potential fraud schemes 
while minimally impacting HHAs due to the switch to a 30-day unit of 
payment.
    Comment: A few commenters expressed support for the NOA and 
recognized that the NOA would be necessary to alert the claims 
processing system of a home health period of care due to the required 
consolidated billing requirements. Other commenters stated that the use 
of a NOA would place burden on HHAs in the form of additional 
paperwork/coordination, and that the NOA requirements were excessive 
and CMS should consider not requiring HHAs to complete the OASIS or 
acquiring a signed plan of care before accepting the NOA. Some 
commenters indicated that the only information that should be required 
to submit the NOA are items like the ``beneficiary's name and a start 
of care date'' and/or a verbal order to begin care. A commenter 
suggested that the NOA be optional in CY 2021 and mandatory in CY 2022.
    Response: We thank those commenters for their support and 
recognition of the need for a NOA. Specifically, we agree that having a 
one-time submission of a NOA within 5 calendar days of the start of 
care, establishing that the beneficiary is under a Medicare home health 
period of care, will cut down on claims denials, help trigger 
consolidated billing edits sooner and may streamline claims processing 
for HHAs. The NOA also provides other HHAs the capability to determine 
if a beneficiary is already under a Medicare home health period of 
care; thereby, reduces the administrative burden associated with 
determining a beneficiary's period of care, reimbursement cancelations, 
and general beneficiary coordination issues. After reviewing all of the 
comments received regarding the information needed to submit the NOA, 
we agree with commenters that since the NOA does not have a payment 
tied to its submission, the requirements to fulfill the NOA should not 
mirror the requirements associated with the submission of a RAP. As 
such, we agree with commenters that the NOA submission criteria should 
require only the necessary information needed to begin Medicare home 
health services for the beneficiary. Therefore, the only information we 
will require for the NOA, starting in CY 2022, will be: (1) A written 
or verbal order from the physician (containing the services required 
for the initial visit) signed and dated by the physician, and if 
verbal, 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 signed by the physician; and 
(2) for the HHA to conduct the initial start of care visit. We believe 
these requirements represent the minimum amount of information that is 
sufficient for establishing a home health period of care and is 
information that the home health agency would already have as part of 
the medical record for beneficiaries admitted to home health.
    Comment: Some commenters requested that CMS consider adopting a 
simple mechanism for timely notification, such as requiring HHAs to 
make notations in the CWF or through the EDI. Other commenters stated 
that submitting a NOA within 5 calendar days from the start of care is 
problematic and that many HHAs would be unable to meet that short 
timeframe. Instead of the 5 calendar day timely filing requirement, 
some commenters suggested lengthening the timeframe to 10-14 calendar 
days to submit a NOA. Other commenters recommended that CMS postpone 
the NOA requirements until CY 2022 or later, to allow HHAs time to 
adjust to the new PDGM 30-day unit of payment.
    Response: There is currently no mechanism that would allow 
providers the ability to make any kind of notation in the CWF. Even if 
the creation of such a mechanism was feasible, the program integrity 
concerns of allowing providers to make their own notations in CWF would 
be exchanging one program integrity vulnerability (the upfront RAP 
payments) for another (allowing providers to make their own notations 
in the CWF). A NOA is needed to identify the initial home health period 
of care for each beneficiary after the elimination of RAPs. Failure to 
provide such notification, (which triggers the home health consolidated 
billing edits and establishes the home health period of care in the 
CWF), could lead to an increase in claims denials. Moreover, not having 
an NOA 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 provider. As we envision it, the home 
health NOA process would be operationalized through an EDI submission, 
similar to that used for submission of the hospice Notice of Election 
(NOE). The purpose of an EDI submission, for NOEs for hospice or NOAs 
for home health, is to minimize data entry errors. Because there is 
already a Medicare claims processing notification, for benefit 
admission, in place, we believe that this should make the home health 
NOA process more consistent and timely for HHAs. Additionally, the use 
of a one-time NOA would streamline HHAs claims processing as the need 
for submitting a RAP for every period of care would be eliminated. The 
HHA would only be submitting the NOA once at the start of care which 
would minimize provider administrative burden for each beneficiary whom 
the HHA provides home health services.
    Concerning the 5 calendar day timely-filing requirement, CMS 
considered different time frames for the submission of the one-time 
NOA, including a 7 calendar day timeframe in which to submit a timely-
filed NOA. However, to

[[Page 60547]]

be consistent with similar requirements in other settings (for example, 
in hospice where the NOE must be submitted within 5 calendar days), we 
believe the 5 calendar day timely-filing requirement would ensure that 
the Medicare claims processing system is alerted as soon as possible to 
mitigate any potential claims denials of other providers for services 
that should be covered under the home health benefit. Furthermore, the 
longer the NOA submission timeframe, the higher the uncertainty for 
providers to determine home health periods of care for a beneficiary. 
Having a policy for submitting a NOA within 5 calendar days, when 
compared to the commenter suggested 10-14 calendar days, will create an 
environment where there is less confusion and administrative burden for 
HHAs, when determining home health periods of care. After reviewing 
comments, we have decided to limit the requirements to submit the NOA 
to only require a verbal order from the physician (containing the 
services required for the initial visit) 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 signed by the physician, and that the HHA conduct the 
start of care visit. Also, in response to comments received, as well as 
CMS operational issues, we will delay the implementation of the NOA 
requirement until CY 2022, and instead will require that HHAs submit a 
``no-pay'' RAP for CY 2021. However, for CY 2021, HHAs would be 
required to submit the ``no-pay'' RAP within five calendar days after 
the start of each 30-day period of care as this would have been the 
requirement for the NOA, if the NOA requirement would have been 
finalized for 2021. Furthermore, in alignment with the proposed NOA 
process, we will also apply a reduction to home health payment if the 
``no-pay'' RAP is not submitted timely. That is, there will be a non-
timely submission reduction in payment amount tied to late submission 
of any ``no-pay'' RAPs when the HHA does not submit the RAP within 5 
calendar days from the start of care date for the first 30-day period 
of care in a 60-day certification period and within 5 calendar days of 
day 31 for the second 30-day period of care in the 60-day certification 
period. This reduction in payment amount would be calculated the same 
way as the NOA non-timely filing policy where the reduction in payment 
amount would be equal to a \1/30\th reduction to the wage-adjusted 30-
day period payment amount for each day from the home health start of 
care date until the date the HHA submits the ``no-pay'' RAP. We are 
adopting such changes under a ``good cause'' waiver of proposed 
rulemaking (see section VII. of this final rule with comment period).
    Comment: A number of commenters opposed CMS' proposal to impose a 
financial penalty on HHAs for failing to submit a timely NOA and 
instead recommended that CMS consider making the notice of admission a 
survey requirement in the future. A commenter strongly urged that the 
NOA submission component be thoroughly vetted with input from 
providers, EHR vendors, MACs; and another recommended that CMS provide 
education to assist home health providers with appropriately adapting 
to all changes.
    Response: Currently the RAP establishes an HHA as the primary HHA 
for the beneficiary during that timeframe and also alerts the claims 
processing system that a beneficiary is under a home health episode and 
triggers the consolidated billing edits required by law under section 
1842(b)(6)(F) of the Act. Also, under the current structure of the RAP, 
providers receive an upfront split-percentage payment upon submission 
of the RAP, providing an incentive for submitting the RAP as early as 
possible, which also ensures the triggering of the consolidated billing 
edits. Without a potential payment impact associated with the 
submission of a NOA, the HHA could submit the NOA when they submit 
their final claim, which would delay turning on the consolidated 
billing edits, thus having an adverse effect on other providers 
providing services to a beneficiary that were likely unaware that the 
beneficiary was already under a home health episode of care. Therefore, 
we believe that having a penalty or a reduction in the payment amount 
for NOAs submitted after the 5 calendar day timely filing requirement 
is appropriate to aid in expediting the submission of the NOA, 
triggering consolidated billing edits as soon as possible and reducing 
claim rejections for other providers who are providing care for a 
beneficiary who is already under a home health episode. Additionally, 
our proposal to assess a financial reduction in payment amount for late 
NOA submission is in alignment with current hospice policy for timely 
submission of the hospice Notice of Election (NOE). Hospices are paid a 
bundled per diem payment amount for each day a beneficiary is under a 
hospice election. If the hospice NOE is not submitted timely (that is, 
within five calendar dates of the date of 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. We 
have found the reduction in payment amount for failure to submit an NOE 
to be an effective tool in ensuring timely NOE submission and believe 
it would be appropriate to apply a similar policy to home health. As 
proposed in the CY 2020 HH PPS proposed rule (84 FR 34640), if an HHA 
failed to submit a timely NOA, the reduction in payment amount would be 
equal to a \1/30\th reduction to the wage-adjusted 30-day period 
payment amount for each day from the home health start of care date 
until the date the HHA submitted the NOA. For example, if an HHA 
submits their NOA one day late (with an NOA submission 6 days after the 
start of care), the result would be a 20 percent reduction to the 30-
day payment amount. Also, if an HHA submits their NOA 25 days late 
(with an NOA submission 30 days after the start of care), there would 
be a 100 percent reduction to the payment The reduction in payment 
amount (R) to the full 30-day period payment amount would be calculated 
as follows:
     Step 1: The number of calendar days (d) from the start of 
care until the NOA is submitted divided by 30 days;
     Step 2: 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 in payment amount would be R = (d/30) 
x P.
    We proposed that there would be no NOA reduction in payment amount 
if the NOA is submitted timely (that is, within the first 5 calendar 
days starting with the start of care date). Likewise, 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 stated 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. This will be an automated process performed by the 
claims processing system.
    We disagree with the commenters' suggestion to make the NOA a 
survey requirement as the NOA, like the current RAP, serves to identify 
that the beneficiary is under a home health period of care and trigger 
consolidated

[[Page 60548]]

billing edits and to establish the home health period of care in the 
Medicare claims processing system. Survey requirements are to ensure 
health and safety standards in accordance with the home health CoPs; 
whereas, the NOA serves a claims processing function for payment. 
Therefore, we believe tying the NOA timely submission requirement to 
payment is appropriate to mitigate any potential denial/recoupment 
issues that might occur if other providers file claims for providing 
services to a beneficiary under a home health period of care before a 
NOA is submitted.
    In the CY 2019 HH PPS proposed rule (83 FR 32390), as well as in 
this year's CY 2020 HH PPS proposed rule (84 FR 34639), we solicited 
for comments on the need for HHAs to submit an NOA within 5 calendar 
days from the start of care to capture that HHA as the primary agency 
for the beneficiary during their home health episode of care. The 
comments we received from both the CY 2019 and 2020 HH PPS proposed 
rules aided in the development of our final NOA policy. We appreciate 
the careful review of the NOA policy and the feedback we received. 
Given that the NOA process will be new for HHAs, we will provide 
education and develop materials for guidance on the NOA policy, 
including MLN Matters[supreg] articles and manual guidance.
    Comment: A commenter stated their concerns regarding the how the 
NOA policy would apply in situations where beneficiaries have a 
Medicare Advantage Plan but changes coverage to traditional Medicare 
during open enrollment or when the patient qualifies for a special 
enrollment while receiving home health services under an existing plan 
of care.
    Response: In this scenario, the HHA would likely fall into one of 
the established timely filing exceptions for NOAs. To pursue this 
potential exception, the HHA would file for an exception with their MAC 
to request a waiver of the timely filing requirement associated with 
submitting the NOA. If the MAC determines that the circumstance meets 
the criteria for an exception, the HHA would receive the full 30-day 
payment amount despite filing the NOA more than 5 calendar days after 
the start of care.
    Comment: Commenters expressed concern regarding all of the changes 
occurring in CY 2020 with implementation of the PDGM and transitioning 
to a 30-day unit of payment and these commenters stated HHAs will not 
have sufficient time to make additional changes to their software 
systems and business processes to accommodate a NOA process in CY 2021. 
Commenters questioned whether the Medicare claims processing system 
would be ready for a NOA process in CY 2021 and cited past issues with 
the hospice NOE process.
    Response: We appreciate commenter concerns about instituting a NOA 
process in CY 2021 after having to make other system changes to 
accommodate the PDGM and a 30-day unit of payment in CY 2020. Likewise, 
we recognize operational issues with the Medicare claims processing 
system that may make a CY 2021 implementation date overly ambitious. 
Specifically, because of the way the current claims processing system 
is developed, any final claim submitted for payment must reconcile to a 
RAP or the claim will be denied. Because of the changes that would be 
required to perform this function, we are not able to do a redesign of 
the claims processing system so that a final claim is processed without 
matching it to a RAP in time for CY 2021 implementation. Therefore, we 
will delay implementation of a NOA process until CY 2022 in order to 
redesign the claims processing system to ensure accurate final claim/
RAP matching.
    We also agree that we want the home health NOA process to implement 
in a way where submission errors are minimized. The intent of a NOA 
process is not to be punitive to providers and we believe that delaying 
implementation of a NOA process until CY 2022 will allow sufficient 
time for both HHA and Medicare systems to be modified to accommodate 
submission of the NOA while mitigating any unintended consequences.
    Final Decision: We are finalizing the following policies as they 
relate to split-percentage payments, Requests for Anticipated Payment 
(RAPs), and submission of a Notice of Admission (NOA):
    For CY 2020:
    We are finalizing the proposal to decrease the upfront split-
percentage payment for 30-day periods of care beginning on and after 
January 1, 2020 from 60/50 percent (depending on whether the period of 
care is the initial or subsequent period) to 20 percent for each 30-day 
period, for existing HHAs, meaning HHAs certified for participation in 
Medicare effective on or before December 31, 2018. We remind commenters 
that in the CY 2019 HH PPS final rule with comment period (83 FR 
56463), we finalized a policy that newly-enrolled HHAs (that is, those 
HHAs certified for participation in Medicare on or after January 1, 
2019) will not receive split-percentage payments for periods of care 
beginning on or after January 1, 2020 and are required to submit a 
``no-pay'' RAP for each 30-day period of care.
    For CY 2021:
    We are finalizing to lower the split-percentage payment to zero for 
all HHAs (that is, existing HHAs as well as newly-enrolled HHAs who 
receive no split-percentage payments in CY 2020) and for all 30-day 
periods of care beginning on or after January 1, 2021. For CY 2021, all 
HHAs will submit a ``no-pay'' RAP at the beginning of each 30-day 
period to allow the beneficiary to be claimed in the CWF and also to 
trigger the consolidated billing edits. This means that existing HHAs 
(those certified for participation in Medicare on or before December 
31, 2018) will have their initial split-percentage payment reduced from 
20 percent in CY 2020 to zero percent in CY 2021 for all 30-day periods 
of care and will submit a ``no-pay'' RAP for all 30-day periods of care 
in CY 2021. Newly enrolled HHAs (those certified for participation in 
Medicare on or after January 1, 2019) will continue to submit ``no-
pay'' RAPs at the beginning of a 30-day period of care in order to 
establish the home health period of care, as well as every 30 days 
thereafter in CY 2021. Therefore, in CY 2021 all HHAs (both existing 
and newly-enrolled HHAs) will submit a ``no pay'' RAP until RAP 
elimination and the implementation of the one-time NOA policy in CY 
2022.
    However, the ``no-pay'' RAP for all HHAs in CY 2021 will require 
less information before the RAP can be submitted. Since we are removing 
the upfront payment associated with the RAP, we are relaxing the 
required information needed to submit the ``no-pay'' RAP. Starting in 
CY 2021, we are finalizing a policy that the information needed to 
submit a ``no-pay'' RAP will mirror the NOA policy we are finalizing in 
this rule. Specifically, we are finalizing a policy that submission of 
``no-pay'' RAPs can be made when the following criteria have been met:
    (1) The appropriate physician's written or verbal order that sets 
out the services required for the initial visit has been received and 
documented as required at Sec. Sec.  484.60(b) and 409.43(d);
    (2) The initial visit within the 60-day certification period must 
have been made and the individual admitted to home health care.
    We are also finalizing a provision which will allow the advance 
submission of certain RAPs in CY 2021 such that in instances where the 
plan of care dictates that multiple 30-day periods of care will be 
required to effectively treat the beneficiary, we will allow the HHA to 
submit both the RAP for the first 30-day period of care and

[[Page 60549]]

the RAP for the second 30-day period of care (for a 60-day 
certification) at the same time to help further reduce provider 
administrative burden. Additionally, for CY 2021, we are finalizing a 
policy where there will be a non-timely submission reduction in payment 
amount tied to late submission of any ``no-pay'' RAPs when the HHA does 
not submit the RAP within 5 calendar days from the start of care date 
for the first 30-day period of care in a 60-day certification period 
and within 5 calendar days of day 31 for the second 30-day period of 
care in the 60-day certification period. This reduction in payment 
amount would be calculated the same way as the NOA non-timely filing 
policy where the reduction in payment amount would be equal to a \1/
30\th reduction to the wage-adjusted 30-day period payment amount for 
each day from the home health start of care date until the date the HHA 
submits the ``no-pay'' RAP. We are also finalizing exceptions to the 
timely filing consequences of the RAP requirements. The RAP timely-
filing policies are in alignment with the substance of the timely-
filing NOA provisions proposed in the CY 2020 proposed rule (84 FR 
34639).
    For CY 2022:
    Starting in CY 2022, we are finalizing that submission of RAPs will 
be eliminated and instead we are finalizing the implementation of a 
one-time NOA submission policy for all HHAs. We are finalizing a policy 
that all HHAs must submit a NOA to their Medicare contractor within 5 
calendar days from the start of care date. The NOA is a one-time 
submission to establish the home health period of care and covers 
contiguous 30-day periods of care until the individual is discharged 
from Medicare home health services. We are also finalizing that NOA 
submission criteria will require HHAs having a verbal or written order 
from the physician that contains the services required for the initial 
visit, and that the HHA has conducted an initial visit at the start of 
care. We are finalizing that there will be a non-timely submission 
reduction in payment amount tied to any late submission of NOAs when 
the HHA does not submit the NOA within 5 calendar days from the start 
of care. That is, if an HHA failed to submit a timely NOA, the 
reduction in payment amount would be equal to a \1/30\th reduction to 
the wage-adjusted 30-day period payment amount for each day from the 
home health start of care date until the date the HHA submitted the 
NOA. We are also finalizing exceptions to the timely filing 
consequences of the NOA requirements. Moreover, we are finalizing the 
corresponding regulation text changes at Sec.  484.205 to effectuate 
these split-percentage payment, RAP and NOA policies.
    Finally, as we noted in the CY 2020 HH PPS proposed rule, after 
publication of the CY 2019 HH PPS final rule with comment period, we 
note that there was an error in titling of the regulations text changes 
associated with Sec.  484.205(g)(2) when the CY 2019 HH PPS final rule 
with comment period went to the Federal Register. Specifically, 
paragraph (g)(2)(iii) was incorrectly titled ``Split percentage 
payments on or after January 1, 2019''. The title of this paragraph 
implies that split percentage payments are not made to newly-enrolled 
HHAs beginning on or after January 1, 2019, which is contradictory to 
the finalized policy on split percentage-payments for newly enrolled 
HHAs. We finalized a policy in the CY 2019 final rule with comment 
period that newly-enrolled HHAs will not receive split-percentage 
payments beginning in CY 2020. As such, in the CY 2020 proposed rule, 
we proposed to make a correction to the regulations text title to 
accurately reflect the finalized policy that newly-enrolled HHAs will 
not receive split-percentage payments beginning in CY 2020. We did not 
receive any comments on this proposed change. However, because of 
proposed revisions to split-percentage payments in the CY 2020 proposed 
rule, the finalized revised title correction, previously at paragraph 
(g)(2)(iii), has been redesignated to Sec.  484.205(g)(2)(ii). The full 
revisions to the text at Sec.  484.205 are found in the regulations 
text section of this final rule with comment period. We are adopting 
both the revised title change from the CY 2019 HH PPS final rule with 
comment period and the finalized changes in this final rule with 
comment period under a ``good cause'' waiver of proposed rulemaking as 
the final policy mirrors that of the proposed NOA policy.
    We note that the regulation at Sec.  484.205(g)(2)(ii), 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 in the February 
15, 2019 MLN Matters article: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19005.pdf.

H. Regulatory Change To Allow Therapist Assistants To Perform 
Maintenance Therapy

    In the CY 2020 HH PPS proposed rule (84 FR 34640) we recognized 
that, 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. We explained that 
although Medicare allows for skilled maintenance therapy in a SNF and 
other outpatient settings, the type of clinician that can provide the 
therapy services varies 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. We noted that commenters on the CY 2019 
Physician Fee Schedule final rule (83 FR 59654) expressed concerns 
about shortages of therapists. That rule also finalized payment for 
outpatient therapy services for which payment is made for services that 
are furnished by a therapist assistant.
    Therefore, we stated that 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. We clarified that 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 stated that this would allow 
home health agencies more latitude in resource utilization, and 
potentially address the concern regarding therapist shortages in home 
health. We also noted that allowing assistants to perform maintenance 
therapy would be consistent with other post-acute care settings, 
including SNFs. As such, we proposed 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 solicited comments regarding this proposal and welcomed feedback 
on whether this proposal would require

[[Page 60550]]

therapists to provide more frequent patient reassessment or maintenance 
program review when the services are being performed by a therapist 
assistant. We also solicited 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). 
And finally, we welcomed 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 in addition to any possible effects 
on the quality of care that could result by allowing therapist 
assistants to perform maintenance therapy.
    The following is a summary of the comments received and our 
responses to comments on the proposed regulatory change to allow 
therapist assistants to perform maintenance therapy:
    Comment: All commenters were supportive of the proposal to change 
the regulations at Sec.  409.44(c)(2)(iii)(C) to allow therapist 
assistants to perform maintenance therapy under the home health 
benefit. Commenters stated that, as therapist assistants provide 
skilled professional services in the home, are licensed in practice, 
and are bound by the same ethical standards as therapists, assistants 
are qualified to provide maintenance therapy. Additionally, commenters 
stated that allowing HHAs to utilize therapist assistants within their 
scope of practice to provide maintenance therapy as well as restorative 
therapy, will support continued access to therapy services and improve 
overall quality of care.
    Response: We thank commenters for their support of this proposal to 
allow therapist assistants to practice at the top of their licensure as 
well as allowing HHAs the flexibility to ensure beneficiary access to 
all available levels of therapy and resources.
    Comment: Several commenters noted that the proposed rule and 
regulations text referenced ``physical therapist assistants'' and 
requested clarification regarding whether proposed Sec.  
409.44(c)(2)(iii)(C) allows all therapist assistants (physical, 
occupational, and speech-language pathology) to perform maintenance 
therapy.
    Response: The proposed changes at Sec.  409.44(c)(2)(iii)(C) would 
allow therapist assistants from all therapy disciplines to perform 
maintenance therapy within their scope of practice. The reference to 
physical therapist assistants in the preamble language was an example 
used to highlight, in general, licensure requirements for therapist 
assistants. However, the example was in regard to the regulations at 
Sec.  484.115(g) and (i), which is in reference to the personnel 
qualifications of both occupational and physical therapist assistants. 
We thank the commenters for pointing out that the regulations text 
however, only referenced physical therapist assistants, and note that 
Sec.  409.44(c)(2)(iii)(C)(1) and (2) has been changed to ``therapist 
assistants,'' and not ``physical therapist assistants.'' We thank 
commenters for their careful review of this proposal and for pointing 
out this important clarification.
    Comment: Commenters provided mixed recommendations regarding the 
importance of tracking whether a visit is for maintenance or 
restorative therapy and whether the service is furnished by a qualified 
therapist or a therapist assistant. A few commenters stated that this 
data would be relevant to future discussions on changes in intensity/
duration of therapy services delivered under the Patient-Driven 
Groupings Model. Other commenters noted that, as both therapists and 
therapist assistants are considered ``qualified'' and provide skilled 
care, it would not be necessary to collect this information. And 
finally we received a few comments stating that allowing therapist 
assistants to perform maintenance therapy would not require the 
supervising therapist to provide more frequent assessments, as this 
provision would align the requirement with the existing standard in 
other settings and for restorative therapy under home health.
    Response: We thank all commenters for their recommendations and 
will take all comments under consideration for future rule-making and 
analysis.
    Final Decision: We are finalizing our proposal to allow therapist 
assistants to perform maintenance therapy under the home health 
benefit. We are finalizing the proposed regulations text at Sec.  
409.44(c)(2)(iii)(C)(1) and (2) with a modification to reflect that all 
therapist assistants, rather than only physical therapist assistants, 
can perform maintenance therapy.

I. 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 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 advance 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 stated in subregulatory guidance in the 
Medicare Benefit Policy Manual, chapter 7,\27\ 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)). Although not 
legally binding, the revised guidance in the Medicare Benefit Policy 
Manual is our preferred policy; therefore, in the CY 2020 HH PPS 
proposed rule, we stated that 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 proposed to change the regulations text at Sec.  
409.43(a). Specifically, we proposed 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

[[Page 60551]]

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 Sec.  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 a CoP requirement, we believe that violations for an 
HHA inadvertently omitting required items are best addressed through 
the survey process, rather than through claims denials for otherwise 
eligible periods of care.
---------------------------------------------------------------------------

    \27\ Medicare Benefit Policy Manual, Chapter 7--Home Health 
Services https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
---------------------------------------------------------------------------

    We solicited comments on the 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 Sec.  484.60(a) that establish the need 
for such services.
    The following is a summary of the comments received, primarily from 
HHAs, on the proposed changes to the home health plan of care 
regulations.
    Comment: Commenters overwhelmingly supported the proposal without 
modifications. In addition, commenters agreed that the individualized 
plan of care must specify services necessary to meet patient-specific 
needs, which would be documented in the comprehensive assessment. 
Commenters also agreed and supported CMS using the survey process to 
address violations of required missing information or items.
    Response: We thank commenters for their support of this proposal. 
We agree that this may help mitigate any claims denials resulting from 
these two items missing from the plan of care and 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.
    Final Decision: We are finalizing to change the regulations text at 
Sec.  409.43(a) 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 Sec.  484.60(a) that establish the 
need for such services. All care provided must be in accordance with 
the plan of care.

IV. 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, 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 with comment (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

[[Page 60552]]

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 with comment (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.
    As we stated in the CY 2020 HH PPS proposed rule, 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 for public reporting under 
the HHVBP Model, we proposed 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 stated that we 
were 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). We further stated that 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.
    As discussed in the proposed rule, 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 stated that 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.
    We further stated that under our proposal, the data reported would 
be limited to one year of the Model. We believe this 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 solicited comment on our proposal to publicly report the TPS and 
TPS 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 also solicited comment on our proposed 
amendment to Sec.  484.315 to reflect this policy. Specifically, we 
proposed 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.
    The following is a summary of public comments received and our 
responses:
    Comment: The majority of commenters supported our proposal to 
publicly report these performance data under the HHVBP Model, citing 
that the data are appropriate for public reporting and, although 
limited to performance during the final year of the Model, such 
information would be beneficial for members of the public in the nine 
states and potentially be valuable to beneficiaries. A commenter 
encouraged CMS to make additional performance data available beyond our 
proposal and to provide a link on the Home Health Compare (HHC) website 
alerting consumers that this supplemental information is available. One 
commenter advised CMS to provide greater clarity on the TPS and TPS 
Percentile Ranking, regarding how the data is measured and how it 
compares

[[Page 60553]]

to the star rating data on HHC, by providing guidance to the general 
public that there will likely be instances where an HHA is a 4 or 5 
star agency but not as high of a performer under the HHVBP Model. The 
commenter expressed concern that the different information available 
through HHC and the HHVBP Model publicly reported information may 
confuse the public.
    Response: As discussed in the proposed rule, we anticipate making 
the HHVBP Model performance data available on the HHVBP Model page 
website at https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model. We will take under consideration the 
commenter's suggestion for also alerting the public of the availability 
of the Model performance data on the HHC website. In addition, as 
discussed in the proposed rule, to accompany the data, we will also 
provide definitions for the HHVBP TPS and the TPS Percentile Ranking 
methodology, as well as descriptions of the scoring methodology, on the 
CMS website to ensure the public understands the relevance of these 
data points and how they were calculated. We will report data by state, 
CCN, and agency name. As the HHVBP Model performance data is 
supplemental to the star ratings, we intend to also include a reference 
to the star ratings available on the CMS website.
    Comment: One commenter stated that this information is already 
available on the HHC website and questioned the utility of reporting 
this information for only the fifth and final year of the model. 
Another commenter stated that the information is not easily understood 
by Medicare beneficiaries or caregivers and is not sufficiently 
impactful. Furthermore, the commenter stated that the impact of HHVBP, 
from a fiscal and quality perspective, is not yet fully understood, 
recent changes in quality metrics for the Model are not yet fully 
integrated, and more changes are likely needed before HHA-specific 
results should be publicly displayed.
    Response: We continue to believe that publicly reporting HHVBP 
performance data would incentivize HHAs to improve quality performance 
under the Model and enhance the current home health public reporting 
processes to assist consumers, patients, providers, stakeholders and 
referral sources in making informed choices on their home health care 
services. We note that the specific information we proposed to publicly 
report is not currently provided on HHC, and that the HHVBP performance 
data would supplement the information provided on HHC by together 
providing a more comprehensive assessment of an HHA's performance 
across a range of quality measures, including the two new composite 
measures included in the HHVBP Model's measure set effective 
performance year 4 (CY 2019). While the publicly reported data would be 
limited to the final performance year of the model, we believe 
providing this data would benefit beneficiaries by encouraging 
participating HHAs to further improve the quality of care they provide.
    We agree that it is important to ensure the public can understand 
the data we publicly report on the HHVBP Model, and as previously 
discussed, will provide accompanying information with the publicly 
reported data to promote public understanding. With regard to the 
recent changes to the Model, in the CY 2019 HH PPS Final Rule, we 
finalized changes to the quality measures and scoring methodology for 
the HHVBP Model. We would only be publicly reporting data from the CY 
2020 performance year, which will be the second performance year to 
which these changes in the quality measures and scoring methodology 
have applied. Prior to publicly reporting the CY 2020 performance data, 
we will have provided participating HHAs with multiple reports on their 
performance under the modified methodology. Moreover, as discussed in 
the proposed rule, 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. Finally, we currently have a publicly available report for 
PY1 on the evaluation of the HHVBP Model on the CMS Innovation Center 
website and will have more information forthcoming about the impact of 
the Model.
    Comment: One commenter encouraged CMS to continue to develop and 
share quality data. However, they also expressed concerns with public 
reporting, particularly for providers who are not participating in the 
HHVBP Model, but are located in markets that overlap with HHVBP states. 
The commenter requested that CMS ensure that the variation of 
participation by geography does not give advantages or disadvantages to 
providers based purely on state line because HHAs located in a HHVBP 
Model state may have more publicly available quality information than 
HHAs outside of those Model states. The commenter expressed concern 
that HHAs in non-participating states would not have the same quality 
information publicly available as the participating HHAs, which could 
be confusing to consumers and referral sources when selecting an 
agency.
    Response: As stated in our response to the previous commenter's 
concern, the TPS and TPS Percentile Ranking would supplement the 
information publicly reported through the HHC star ratings and other 
public resources, which include information about both HHVBP Model 
participating and non-participating HHAs and therefore can be used by 
patients or providers to review quality information on HHAs in non-
HHVBP Model states. The HHVBP Model performance data would be publicly 
reported only for participating HHAs in the nine states that qualified 
for a payment adjustment percentage based on their Total Performance 
Score in the fifth and final performance year (CY 2020) of the Model. 
We believe that making these HHVBP Model performance data available on 
the CMS Innovation Center's HHVBP Model web page, along with 
information about what this data represents and how it was calculated, 
will minimize any potential confusion.
    Final Decision: For the reasons stated and after consideration of 
the comments received, we are finalizing the public reporting of 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 
HHVBP Model states that qualified for a payment adjustment for CY 2020. 
We are also finalizing our proposed amendment to Sec.  484.315 to 
reflect this policy. As discussed in the proposed rule and in this 
final rule with comment period, we expect that these data will be made 
available on the HHVBP Model page of the CMS Innovation Center website 
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.
    We received several out-of-scope comments, including requests to 
expand the HHVBP Model and for more information about when we may 
consider expansion. We thank the commenters for their interest and will 
address any future changes through rulemaking. We also note that HHVBP 
Model evaluation reports are currently publicly available on the CMS 
website (https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model), which will be updated with forthcoming 
reports.

[[Page 60554]]

C. Removal of Improvement in Pain Interfering With Activity Measure 
(NQF #0177)

    As discussed in section V.C of this final rule with comment period, 
after careful consideration of the concerns raised by commenters, the 
responses provided to those concerns and the discussion of alignment 
across the QRPs, CMS is finalizing the removal of 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. HHAs will 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. Data for this measure will be publicly 
reported on HH Compare until April 2020. As we discussed in the CY 2020 
HH PPS proposed rule (84 FR 34643), 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. 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 following rules:
     CY 2007 HH PPS final rule (71 FR 65888 through 65891).
     CY 2008 HH PPS final rule (72 FR 49861 through 49864).
     CY 2009 HH PPS update notice (73 FR 65356).
     CY 2010 HH PPS final rule (74 FR 58096 through 58098).
     CY 2011 HH PPS final rule (75 FR 70400 through 70407).
     CY 2012 HH PPS final rule (76 FR 68574).
     CY 2013 HH PPS final rule (77 FR 67092).
     CY 2014 HH PPS final rule (78 FR 72297).
     CY 2015 HH PPS final rule (79 FR 66073 through 66074).
     CY 2016 HH PPS final rule (80 FR 68690 through 68695).
     CY 2017 HH PPS final rule (81 FR 76752).
     CY 2018 HH PPS final rule (82 FR 51711 through 51712).
     CY 2019 HH PPS final rule with comment period (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 with comment (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 \28\ measures for the CY 2021 
program year, as outlined in Table 28.
---------------------------------------------------------------------------

    \28\ The HHCAHPS has five component questions that together are 
used to represent one NQF-endorsed measure.

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[[Page 60555]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.045

D. Removal of HH QRP Measures Beginning With the CY 2022 HH QRP

    In line with our Meaningful Measures Initiative, in the CY 2020 HH 
PPS proposed rule (84 FR 34644 through 34645), we proposed to remove 
one measure from the HH QRP beginning with the CY 2022 HH QRP.
1. Removal of the Improvement in Pain Interfering With Activity Measure 
(NQF #0177)
    We are removing pain-associated quality measures from our quality 
reporting programs in an effort to mitigate any potential unintended, 
over-prescription of opioid medications inadvertently driven by these 
measures. In the CY 2020 HH PPS proposed rule (84 FR 34644 and 34645), 
we proposed 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.\29\
---------------------------------------------------------------------------

    \29\ 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.
---------------------------------------------------------------------------

    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,

[[Page 60556]]

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 proposed 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.
    We stated in the proposed rule that if we finalized 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 this measure beginning January 1, 2021. We stated we are 
unable to remove M1242 earlier due to the timelines associated with 
implementing changes to OASIS. We also stated that if we finalized this 
proposal, data for this measure would be publicly reported on HH 
Compare until April 2020.
    We invited public comment on this proposal and received several 
comments. A discussion of these comments, along with our responses 
follows.
    Comment: Several commenters supported our proposal to remove the 
Improvement in Pain Interfering with Activity Measure (NQF #0177) from 
the HH QRP as well as the associated OASIS item M1242 used to calculate 
the measure. One commenter supported removing the measure but 
recommended that CMS retain M1242 for purposes of risk-adjustment. A 
few commenters expressed support for CMS' proposal to add new, 
standardized pain assessment items to the OASIS that would enable the 
agency to continue collecting data on pain.
    Response: We appreciate commenters' support for our proposal to 
remove the Improvement in Pain Interfering with Activity Measure (NQF 
#0177) as part of the overall HHS strategy to address opioid misuse. We 
note that we do not have the authority under the HH QRP to retain the 
OASIS item M1242 for risk-adjustment purposes once removed from the HH 
QRP. We will evaluate the SPADE Items in section V.H.3. of this final 
rule with comment period for risk adjustment use in the future.
    Comment: Several commenters requested that CMS develop or share its 
plans to address pain management in its quality reporting programs 
(QRPs) in the future after the related measures and data elements are 
removed, noting that the agency should be consistent in its approach to 
addressing patient pain. One commenter recommended that CMS track the 
HHA's approach to appropriate teaching of non-pharmacological pain 
management options as a part of the individualized care plan.
    Response: In the CY 2020 HH PPS proposed rule (84 FR 34672 through 
34675) we proposed to add new, standardized patient assessment data 
elements on pain to the OASIS such that agencies would continue to 
collect information on patient pain that could support care planning, 
quality improvement, and potential quality measurement, including risk 
adjustment. In section V.H.3. of this rule, we have finalized the 
adoption of the three new pain data elements. We believe their 
inclusion on the next version of the OASIS will underscore the priority 
of managing pain. In addition, the CMS Roadmap to Address the Opioid 
Epidemic includes emphasis on non-pharmacological options for managing 
pain as critical in the efforts to reduce over-reliance on and misuse 
of opioids. We are committed to continuing to communicate our strategy 
for both promoting pain management and appropriate use of opioids.
    Comment: The majority of commenters did not support the proposal to 
remove the Improvement in Pain Interfering with Activity Measure (NQF 
#0177). Several commenters stated that pain is an important concern for 
home health patients and that information on pain was valuable to the 
care team and for quality improvement. These commenters noted that pain 
can be a root cause of declining health and well-being and is linked to 
patient quality of life. Some commenters said that measuring pain 
improvement helps assess treatment efficacy.
    Other commenters noted the lack of evidence that measuring pain 
level in home health is linked to increased opioid use. One commenter 
additionally noted that generally home health agencies do not prescribe 
opioids.
    While some commenters appreciated CMS' efforts to address the 
opioid epidemic, they opposed removal of this measure, expressing 
concern that this removal could decrease the priority of efforts to 
manage pain, including chronic pain. A few commenters noted that 
greater emphasis on pain management and impact, as well as promoting 
and educating providers on non-pharmacological pain management 
strategies and care plans, were important to addressing opioid misuse.
    Response: We appreciate the feedback given by the commenters and 
acknowledge the concerns raised. We agree that pain is an important 
concern for home health patients. In response to recommendations from 
the President's Commission on Combatting Drug Addiction and the Opioid 
Crisis, to comply with the requirements of the Substance Use-Disorder 
Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for 
Patients and Communities Act (Pub. L. 115-271), and to avoid any 
potential unintended consequences, in the CY 2019 OPPS/ASC final rule 
(83 FR 59149) we finalized to update the Hospital Consumer Assessment 
of Healthcare Providers and Systems (HCAHPS) patient experience of care 
survey measure by removing three recently revised pain communication 
questions. We proposed the removal of the Improvement in Pain 
Interfering with Activity Measure (NQF #0177) measure in the spirit of 
alignment with these efforts.
    Additionally, we proposed the removal of this measure to minimize 
any potential overprescribing of opioids associated with incentives to 
improve scoring on the measure. We have particular concern with quality 
measures that assess directly or indirectly whether or not a patient's 
pain has improved, as we believe such measures may more directly 
incentivize over-prescribing of opioids. We have addressed this 
specific issue in previous rule-making. In the FY 2017 IPPS/LTCH PPS 
final rule (82 FR 38342), we similarly finalized refinements to the 
HCAHPS Survey measure pain management questions, removing questions 
such as ``During this hospital stay, how often was your pain well 
controlled?'' and ``During this hospital stay, how often did the 
hospital staff do everything they could to help you with your pain?'', 
to minimize such incentives. We plan to further evaluate this issue 
across all programs.
    Comment: Several commenters expressed concern that removal of M1242 
would leave the OASIS without any items to assess pain, noting that 
pain interference not only captures pain intensity, but also the impact 
of pain on function.

[[Page 60557]]

    Response: Given the adoption of the new pain items, in section 
V.H.3. of this rule the OASIS would continue to contain items that 
assess pain and the impact on function. CMS will require HHAs to report 
OASIS M1242 through December 31, 2020. CMS will begin requiring 
reporting of the new pain items finalized in section V.H.3. of this 
rule January 1, 2021. This timeline will ensure that there is no gap in 
the assessment and reporting of pain for this population.
    Final Decision: After careful consideration of the concerns raised 
by commenters, the responses provided to those concerns and the 
discussion of alignment across the QRPs, we are finalizing our proposal 
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. HHAs 
will 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. Data for this measure will 
be publicly reported on HH Compare until April 2020.

E. New and Modified HH QRP Quality Measures Beginning With the CY 2022 
HH QRP

    In the CY 2020 HH PPS proposed rule (84 FR 34645 through 34650), we 
proposed 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 proposed 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.
    In addition to the two measure proposals, we proposed 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. Transfer of Health Information to the Provider-Post-Acute Care (PAC) 
Measure
    The 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.\30\ 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.\31\
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    \30\ 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.
    \31\ 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

[[Page 60558]]

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.32 33 34 35 36 37 
Poor communication and coordination across health care settings 
contributes to patient complications, hospital readmissions, emergency 
department visits, and medication errors. 
38 39 40 41 42 43 44 45 46 47 48 49 Communication has been 
cited as the third most frequent root cause in sentinel events, which 
The Joint Commission defines \50\ 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.\51\ When care transitions 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.52 53 54 55 56 57
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    \32\ 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.
    \33\ 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.
    \34\ 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.
    \35\ 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.
    \36\ 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.
    \37\ Boling, P.A., ``Care transitions and home health care,'' 
Clinical Geriatric Medicine, 2009, Vol.25(1), pp. 135-48.
    \38\ 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.
    \39\ 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.
    \40\ 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.
    \41\ 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
    \42\ 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.
    \43\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., `` The 
revolving door of rehospitalization from skilled nusing facilities'' 
Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \44\ 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.
    \45\ 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.
    \46\ 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.
    \47\ 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.
    \48\ Lattimer, C. (2011). When it comes to transitions in 
patient care, effective communication can make all the difference. 
Generations, 35(1), 69-72.
    \49\ 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.
    \50\ The Joint Commission, ``Sentinel Event Policy'' available 
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/
    \51\ 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.
    \52\ 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.
    \53\ 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.
    \54\ 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.
    \55\ 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.
    \56\ 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.
    \57\ 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.58 59 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.\60\ The communication of health information and patient care 
preferences is critical to ensuring safe and effective transitions from 
one health care setting to another.61 62
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    \58\ 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.
    \59\ 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/.
    \60\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US 
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
    \61\ 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/.
    \62\ 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.63 64 65 Patients in PAC

[[Page 60559]]

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.66 67 Preventable adverse drug events (ADEs) may 
occur after hospital discharge in a variety of settings including 
PAC.\68\ For older patients discharged from the hospital, 80 percent of 
the medication errors occurring during patient handoffs relate to 
miscommunication between providers \69\ and for those transferring to 
an HHA, medication errors typically relate to transmission of 
inaccurate discharge medication lists.\70\ 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.71 72
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    \63\ 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.
    \64\ 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
    \65\ 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.
    \66\ 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.
    \67\ 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.
    \68\ 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.
    \69\ 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.
    \70\ 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.
    \71\ 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.
    \72\ 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 \73\ and hospital to home.\74\ 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.\75\
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    \73\ 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.
    \74\ 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.
    \75\ 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, 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 previous definition 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 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 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,\76\ January 27, 2017, and August 3, 2017 \77\ 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

[[Page 60560]]

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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    \76\ 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.
    \77\ 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.
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    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 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 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: https://www.qualityforum.org/Projects/i-m/MAP/PAC-LTC_Workgroup/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 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 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 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 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 measure to the NQF for consideration of endorsement when feasible.
(e) Quality Measure Calculation
    The 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 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 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 measure also 
collects data on how information is exchanged in PAC facilities, 
informing consumers and providers on how

[[Page 60561]]

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 measure, 
including information about the measure calculation and the 
standardized items used to calculate this measure, we referred 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 quality measure is the OASIS assessment instrument for 
HH patients.
    For more information about the data submission requirements we 
proposed for this measure, we refer readers to section V.L.2. of this 
final rule with comment period.
    We invited public comment on this proposal and received one comment 
specific to this measure. A discussion of this comment, along with our 
responses, appears below. The remaining comments we received on this 
measure also addressed the second transfer of health information that 
we proposed to adopt. Those comments, along with our responses and our 
final decision concerning both measures, can be found in section V.E.2 
of this final rule with comment period.
    Comment: One commenter expressed concerns that the proposed 
Transfer of Health Information to the Provider-Post-Acute Care quality 
measure denominator does not recognize the importance of transmitting 
the medication list to providers, such as therapists, that are not 
included in the proposed definition of ``admitting provider.
    Response: We appreciate the suggestion to expand the Transfer of 
Health Information to The Provider-Post-Acute Care measure to assess 
the transfer of health information to include other providers such as 
physical therapists. We recognize the importance of all provider 
disciplines. Our proposed definition of ``admitting provider'' for 
purposes of the proposed measure was informed through our measure 
development and pilot testing process, and it focuses upon providers 
that can be readily identified through the discharge location item on 
the OASIS. This would not preclude the sharing of information that will 
help inform providers such as therapist who may be involved in the 
patients care once transferred or discharged. At this time, we believe 
that the current means of provider identification will improve the 
reliability and validity of the measure.
2. Transfer of Health Information to the Patient-Post-Acute Care (PAC) 
Measure
    The 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.\78\ 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.79 80 81 82 
83 Individuals who use PAC care services are particularly 
vulnerable to adverse health outcomes due to their higher likelihood of 
having multiple comorbid chronic conditions, polypharmacy, and 
complicated transitions between care settings.84 
85 Upon discharge to home, individuals in PAC settings may 
be faced with numerous medication changes, new medication regimes, and 
follow-up details.86 87 88 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.89 90
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    \78\ 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.
    \79\ 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.
    \80\ 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.
    \81\ 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.
    \82\ 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.
    \83\ 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.
    \84\ 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.
    \85\ 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.
    \86\ 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.
    \87\ 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.
    \88\ 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.
    \89\ 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.
    \90\ 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.91 92 Most 
PAC EHR systems

[[Page 60562]]

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.\93\
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    \91\ 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.
    \92\ 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.
    \93\ 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 measure was developed after consideration of feedback we 
received from stakeholders, and four TEPs convened by our contractors. 
Further, the 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,\94\ January 27, 2017, and August 3, 2017 \95\ 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 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.
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    \94\ 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-ssessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-nformation-TEP_Summary_Report_Final-June-2017.pdf.
    \95\ 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.
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    Our measure development contractors solicited stakeholder feedback 
on the 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-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: https://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 
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.

[[Page 60563]]

However, we note that we intend to submit the measure to the NQF for 
consideration of endorsement when feasible.
(e) Quality Measure Calculation
    The calculation of the 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 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 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 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 
proposed for this measure, we refer readers to section V.L.2. of this 
final rule with comment period.
    Commenters submitted the following comments on the two proposed 
transfer of health information measures that we proposed to adopt, 
beginning with the CY 2022 HH QRP. A discussion of these comments, 
along with our responses, appears in this section of this final rule 
with comment period.
    Comment: The majority of commenters supported CMS's proposal to 
adopt the Transfer of Health Information to the Provider-Post-Acute 
Care quality measure and Transfer of Health to the Patient-Post-Acute 
Care quality measure beginning with the CY 2022 HH QRP. Many cited the 
importance of timely and accurate discharge documentation to ensure 
patient safety.
    Response: We appreciate commenters' support for adoption of the 
Transfer of Health Information quality measures beginning with the CY 
2022 QRP. We concur that timely information sharing during the care 
transfer process is critical to a safe patient transfer.
    Comment: Multiple commenters stated that all measures used in the 
HH QRP should be endorsed by the National Quality Forum.
    Response: While section 1899B(e)(2)(A) of the Act requires that any 
measure specified by the Secretary be endorsed by the entity with a 
contract under section 1890(a) of the Act, which is currently the 
National Quality Form (NQF), 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 a consensus organization identified by the Secretary. While 
these two measures are not currently NQF-endorsed, we recognize that 
the NQF endorsement process is an important part of measure 
development. As discussed in the CY 2020 HH PPS proposed rule (84 FR 
34647 through 34648), there is currently no feasible NQF-endorsed 
measure that we could adopt under section 1899B(c)(1)(E) of the Act 
that better addresses the Transfer of Health Information measure 
domain. We plan to submit the measures for NQF endorsement 
consideration as soon as feasible.
    Comment: A few commenters recommended that we expedite the timeline 
for beginning the collection of data on these measures. These 
commenters also recommended that we refrain from making any new 
revisions to the OASIS, such as adding new items for at least five 
years if we finalize the proposed changes.
    Response:
    In the case of the Transfer of Health Information-Provider and 
Transfer of Health-Patient Post-Acute Care quality measures, the 
timeline outlined is intended to give providers sufficient time to 
become familiar with the new measures and participate in trainings and 
other stakeholder engagement initiatives prior to submitting data on 
the measures. In response to the request for not making any new 
revisions, we will take this recommendation under consideration.
    Comment: Several commenters expressed concern about anticipated 
additional burden of collecting the additional assessment data needed 
to calculate these measures.
    Response: We are mindful of burden that may occur from the 
collection and reporting of data and measures we adopt for our quality 
reporting programs. The timely and complete transfer of information 
focuses on the medication list, as recommended by our TEP and through 
public comment. The transfer of health information measures are each 
calculated using a single OASIS item and based upon the TEP feedback 
and pilot test findings, we do not believe that it will be overly 
burdensome for HHAs to report these items. We also believe that these 
measures will likely drive improvements in the transfer of medication 
information between providers and with patients, families, and 
caregivers and thus justify the additional burden being imposed.
    Comment: A few commenters recommended CMS adopt fewer process 
measures and more outcome measures for the HH QRP.
    Response: While we agree that outcome measures are important, and 
have worked to consistently adopt outcome and claims-based measures, we 
also believe that process measures, are important and necessary to 
promote the quality of care furnished by HHAs. The proposed transfer of 
health measures in particular will ensure care is coordinated at the 
time of discharge.
    Comment: One commenter recommended that the data element for the 
Transfer of Health Information to the Patient-Post-Acute-Care should be 
clear that if a Medicare beneficiary has a family caregiver, then that 
caregiver should receive the list if the beneficiary and family 
caregiver consent, even if it is also provided to the patient and that 
the patient, family, or caregiver should be given a chance to ask 
questions about the medication list to ensure they understand it.
    Response: The Transfer of Health Information to the Patient-Post-
Acute Care data element asks about the transfer of a reconciled 
medication list to the patient, family and/or caregiver. We acknowledge 
the importance of family and/or caregivers and encourage collaboration 
between the HHA and the family or caregiver when authorized by the 
patient. HHA staff routinely provide opportunities for family and/or 
caregivers to identify questions.
    Comment: A few commenters requested CMS to clarify what is meant by 
``reconciled [medication] list'' and

[[Page 60564]]

that the contents of a reconciled medication list are left up to the 
discretion of the provider.
    Response: Suggested elements detailed in the definition are for 
guidance purposes only and are not a requirement in order to meet the 
measure criteria. Defining the completeness of the medication list is 
left to the discretion of the providers and patients who are 
coordinating this care.
    Comment: One commenter questioned the alignment of these proposed 
measures with the rule ``Revisions to Requirements for Discharge 
Planning for Hospitals, Critical Access Hospitals, and Home Health 
Agencies'' (CMS-3317-F) and requested CMS ensure alignment of an 
electronic option to transmit this information that aligns with the 
requirements in the Discharge Planning final rule.
    Response: The final rule, ``Revisions to Requirements for Discharge 
Planning for Hospitals, Critical Access Hospitals, and Home Health 
Agencies'' (CMS-3317-F) was finalized on September 30, 2019 (84 FR 
51836). In the Discharge Planning final rule, we established that 
effective November 29, 2019 an HHA must establish an effective 
discharge planning process for each patient when discharged to another 
PAC setting and establish a standard for the contents of the discharge 
summary. In addition, we established that an HHA must comply with 
additional requests from the receiving facility or agency when 
necessary for the treatment of the patient. We have worked closely with 
our counterparts in the agency to ensure proper alignment of this 
policy proposal and the requirements in our Discharge Planning final 
rule. We would like to note that neither policy contains a requirement 
for electronic options to transmit the medication list or Discharge 
planning information electronically. CMS is committed to furthering 
interoperability in post-acute care and we encourage HHAs that are 
electronically capturing discharge information to exchange that 
information electronically with providers who have the capacity to 
accept it.
    Comment: A commenter noted that an HHA may not find out information 
about a transfer to an inpatient facility until after the fact and may 
not know to which facility the patient has been transferred.
    Response: We acknowledge that there are times when a home health 
agency may not be notified timely about a transfer to an inpatient 
facility. This situation would prevent the HHA from being able to 
transfer the medication information to the new facility. To address 
this particular concern we have approved a Not Applicable (NA) response 
at the Transfer to Inpatient Facility time point.
    Final Decision: After careful consideration of the public comments 
we received, we are finalizing our proposal to adopt the Transfer of 
Health Information to the Provider-Post-Acute Care (PAC) and Transfer 
of Health Information to the Patient-Post-Acute Care (PAC) Measures 
under section 1899B(c)(1)(E) of the Act beginning with the CY 2022 HH 
QRP as proposed.
3. Update to the Discharge to Community (DTC)-Post Acute Care (PAC) 
Home Health (HH) Quality Reporting Program (QRP) Measure
    In the CY 2020 HH PPS proposed rule (84 FR 34650 through 34651), we 
proposed to update the specifications for the DTC--PAC HH QRP measure 
(NQF #3477) to exclude baseline nursing facility (NF) residents from 
the measure. This measure exclusion aligns with the updates to measure 
exclusions for the DTC-PAC measures that we finalized in the FY 2020 
SNF QRP, IRF QRP, and LTHC QRP final rules. The DTC--PAC HH QRP measure 
(NQF #3477) 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 (NQF #3477) 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 only an Omnibus Budget Reconciliation Act 
(OBRA) 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, in the CY 2020 HH PPS proposed rule (84 FR 34650 
through 34651), we proposed to exclude baseline NF residents from the 
DTC-PAC HH QRP measure beginning with the CY 2021 HH QRP. We proposed 
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 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 (NQF #3477), including technical information about the proposed 
exclusion, we referred 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.
    We invited public comment on this proposal and received several 
comments. A discussion of these comments, along with our responses, 
appears in this section of this final rule with comment period.
    Comment: The majority of commenters supported CMS' proposal to 
exclude baseline nursing home residents from the DTC-PAC HH QRP measure 
(NQF #3477), and expressed appreciation for CMS' responsiveness to 
stakeholder feedback.
    Response: CMS appreciates commenters' support for excluding NF

[[Page 60565]]

residents from the DTC-PAC HH QRP measure (NQF #3477).
    Comment: MedPAC did not support the proposed exclusion of baseline 
nursing facility residents from the DTC--PAC HH QRP measure (NQF 
#3477). They suggested that CMS instead expand their definition of 
``return to the community'' to include baseline nursing home residents 
returning to the nursing home where they live, as this represents their 
home or community. MedPAC also stated that providers should be held 
accountable for the quality of care they provide for as much of their 
Medicare patient population as feasible.
    Response: We agree with MedPAC that providers should be held 
accountable for the quality of care for as much of their Medicare 
population as feasible. However, we believe this exclusion is necessary 
to enhance the validity of this measure. For baseline nursing facility 
residents, the goal of care is successful discharge back to their 
residence at the nursing facility, which is considered an unsuccessful 
outcome in this measure, rather than a discharge to the community 
(defined as home/self-care without HH services). The use of risk 
adjustment is inappropriate when the measurable outcome of success is 
not the goal of care for this population.
    Community is traditionally understood as representing non-
institutional settings by policy makers, providers, and other 
stakeholders. Including long-term care NF in the definition of 
community would confuse this long-standing concept of community and 
would misalign with CMS' definition of community in patient assessment 
instruments. We conceptualized this measure using the traditional 
definition of ``community'' and specified the measure as a discharge to 
community measure, rather than a discharge to baseline residence 
measure.
    Baseline NF residents represent an inherently different patient 
population with not only a significantly lower likelihood of discharge 
to community settings, but also a higher likelihood of post-discharge 
readmissions and death compared with PAC patients who did not live in a 
NF at baseline. The inherent differences in patient characteristics and 
PAC processes and goals of care for baseline NF residents and non-NF 
residents are significant enough that we do not believe risk adjustment 
using a NF flag would provide adequate control. While we acknowledge 
that a return to nursing home for baseline NF residents represents a 
return to their home, this outcome does not align with our measure 
concept. Thus, we have chosen to exclude baseline NF residents from the 
measure.
    Comment: One commenter noted that the Discharge to Community 
measure may incentivize inappropriate discharges, adding that the 
community is not always the best option for some patients. This 
commenter further noted that this measure could result in agencies not 
accepting certain types of patients.
    Response: We appreciate the importance of incentivizing holistic, 
patient-specific health decisions and to that end The Discharge to 
Community measure is risk adjusted based on multiple initial patient 
characteristics, including diagnoses and previous hospitalizations. 
This risk adjustment accounts for potentially higher risk of 
readmission or death and addresses any incentives to not admit or 
inappropriately discharge high-risk patients.
    Final Decision: After consideration of the public comments, we are 
finalizing our proposal to exclude baseline NF residents from the DTC-
PAC HH QRP measure (NQF #3477) beginning with the CY 2021 HH QRP. We 
are also finalizing our proposal 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 
intervening community discharge between the NF stay and qualifying 
hospitalization.
F. HH QRP Quality Measures, Measure Concepts, and Standardized Patient 
Assessment Data Elements Under Consideration for Future Years: Request 
for Information
    In the CY 2020 HH PPS proposed rule (84 FR 34651), we sought 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 
29 for future years in the HH QRP.
[GRAPHIC] [TIFF OMITTED] TR08NO19.046


[[Page 60566]]


    While we are not responding to comment submissions in response to 
this Request for Information in the CY 2020 HH PPS final rule with 
comment period, nor are we finalizing any of these measures, measure 
concepts, and SPADEs under consideration for the HH QRP in this CY 2020 
HH PPS final rule with comment period, we appreciate all commenter 
suggestions and intend to use this input to inform our future measure 
and SPADE development efforts.
    Comment: A number of commenters supported the broad range of 
measures and data elements suggested as future additions to the OASIS 
and the HH QRP. One provider stated strong support for CMS's plans to 
adopt an exchange of health information measure, stressing the need for 
adoption of interoperable health information technology in PAC settings 
and in this case in home health. A number of providers supported future 
adoption of functional improvement outcome measures while a few 
commenters stressed the value of having maintenance measures focused on 
patients who are not likely to improve. Another commenter stressed the 
need for avoiding unintended consequences in punishing HHAs with 
patients who are expected to decline. A commenter supported the opioid 
use and frequency quality measure, but stressed the need to ensure that 
providers aren't penalized for appropriately prescribing medications. 
Another commenter expressed concern that the adoption of an opioid use 
and frequency measure may adversely affect the appropriate use of 
opioids. A few providers suggested a criterion of CMS only including 
measures in the HH QRP program that have already received NQF 
endorsement. A few others suggested that CMS strongly pursue removing 
less useful measures and data elements from the HH QRP at the time in 
which new measures or data elements are considered for supplementing 
the HH QRP.
    With respect to future SPADE proposals, one commenter strongly 
supported introduction of a caregiver status data element. A few other 
commenters suggested the need to add data elements that address housing 
and food security to any social determinants of health SPADEs under 
consideration. One commenter stressed the need for current and future 
SPADEs to more adequately account for patients with a broader range of 
speech, hearing, and swallowing abilities. Finally, one commenter 
suggested that CMS should not consider introducing any data element 
that has not already undergone data testing since this limits the 
ability of providers and the general public to provide input into 
potential implementation implications of the data elements.
    We appreciate the feedback submitted on these issues.

G. 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 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 final rule with comment period, and believe 
that this testing supports their use in our PAC assessment instruments. 
Therefore, we proposed to adopt many of the same SPADEs that we 
previously proposed to adopt, along with other SPADEs.
    In the CY 2020 HH PPS proposed rule (84 FR 34652), we proposed 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 proposed 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

[[Page 60567]]

purposes of the HH QRP, we proposed 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 proposed to use 
SOC for purposes of admissions because, in the HH setting, the start of 
care is functionally the same as an admission.
    We proposed 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, 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.
    We invited public comment on these proposals and received several 
comments. A discussion of these comments, along with our responses, 
appears in this section of this final rule with comment period.
    Comment: A majority of commenters expressed support for the 
adoption of the SPADEs within the categories of: Cognitive function and 
mental status; special services, treatments, and interventions; medical 
condition and comorbidity data; and impairments. Supporters of the 
SPADE proposals highlighted the benefit of assessing the areas of 
SPADEs across post-acute care settings.
    Response: CMS thanks the commenters for their support of the goals 
of standardization and of the proposed SPADEs. We selected the proposed 
SPADEs in part because of the attributes that the commenters noted.
    Comment: Some commenters suggested the need to remove duplicative 
items in the OASIS and to continually assess the value of the proposed 
data elements. A number of commenters expressed overall concern with 
the adoption of the SPADEs due to an anticipated increase in 
administrative burden for providers. Commenters recommended mitigating 
this burden through introducing SPADEs over a number of years instead 
of all at one time. Numerous commenters supported the following 
recommendations:
    1. CMS should issue a draft of the assessment tool no later than 6 
months prior to the implementation date, to allow for staff training 
and other necessary preparations required for agency implementation;
    2. CMS should use the authority permitted by the IMPACT Act to 
waive the Paperwork Reduction Act (PRA) requirements related to 
modification of the assessment tools for providers subject to the 
IMPACT Act and expedite CMS's ability to issue a final version of the 
revised OASIS instrument in a timely manner;
    3. CMS should refrain from issuing any revisions to the OASIS 
instrument for at least 5 years after the 2021 implementation of the 
proposed changes.
    Response: Our development and selection process for the SPADEs 
prioritized data elements essential to comprehensive patient care. 
While the introduction of SPADEs will require some additional burden, 
we maintain that there will be significant benefit associated with each 
of the SPADEs to providers and patients, in that they are clinically 
useful (for example, for care planning), they support patient-centered 
care, and they will promote interoperability and data exchange between 
providers.
    We appreciate the importance of avoiding undue burden and will 
continue to evaluate and consider any burden the IMPACT Act and the HH 
QRP places on home health providers. In implementing the IMPACT Act 
thus far, we have taken into consideration any new burden that our 
requirements might place on PAC providers. We were also cognizant of 
the changes that providers will need to make to implement these 
additions to the OASIS. In CY 2018 HH PPS final rule (82 FR 51732), we 
provided information about goals, scope, and timeline for implementing 
SPADEs, as well as updated HHAs about ongoing development and testing 
of data elements through other public forums. In terms of the timing of 
the release of the OASIS, we plan to publish a draft of the revised 
OASIS instrument in early 2020.
    Comment: Some commenters suggested that CMS implement the SPADES 
more slowly than proposed.
    Response: We believe the current schedule is appropriate because it 
aligns with the requirements of the IMPACT Act and because of our 
efforts to date to prepare for the implementation of new cross-setting 
SPADES. Our development and selection process for the SPADEs we are 
adopting in this final rule with comment period reflect prioritized 
data elements that are essential to comprehensive patient care. We 
maintain that there will be significant benefit associated with each of 
the SPADEs to providers and patients, in that they are clinically 
useful (for example, for care planning), they support patient-centered 
care, and they will promote interoperability and data exchange between 
providers. We therefore believe that the proposed implementation 
timeline for the SPADEs is appropriate.

[[Page 60568]]

    Comment: One commenter expressed concerns about the methodology of 
the National Beta Test, noting their belief that the sample was not 
nationally representative.
    Response: The National Beta Test was designed to generate valid and 
robust national SPADE performance estimates for each of the four PAC 
provider types. This required acceptable geographic diversity, 
sufficient sample size, and reasonable coverage of the range of 
clinical characteristics. To meet these requirements, the National Beta 
Test was carefully designed so that data could be collected from a wide 
range of environments (such as geographic regions, and PAC providers of 
different types, sizes, and ownership), allowing for thorough 
evaluation of candidate SPADE performance in all PAC settings. The 
approach included a stratified random sample, to maximize 
generalizability, and subsequent analyses included extensive checks on 
the sampling design.
    In a document that we issued in conjunction with the proposed rule 
(entitled ``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), we described key findings from 
the National Beta Test related to the proposed SPADEs. We refer readers 
to an initial volume of the National Beta Test report that details the 
methodology of the field test (``Development and Evaluation 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).
    Comment: Some commenters recommended that CMS leverage electronic 
health record initiatives to better utilize SPADEs in home health 
agencies.
    Response: It is our intention to use the SPADE data to inform the 
common standards and definitions to facilitate interoperable exchange 
of data. We believe that a core, standardized set of data elements that 
could be shared across PAC and other provider types is an important 
first step to foster this interoperability between providers. We are 
hopeful that by requiring the collection of standardized data, the 
SPADEs may spur providers, such as home health agencies, to adopt 
health information technology that eases the burden associated with 
data collection and data exchange. Further, we believe that the 
collection of these SPADEs reflect common clinical practice and will 
improve discharge planning, as well as address errors that can occur 
during transition from one setting to the next. We note the collection 
of the SPADEs is one of many tasks to supporting interoperability. We 
will take into consideration how best to decrease burden from data 
collection including our manual processes. Additionally, we will take 
into consideration ways to help incentivize providers to adopt health 
information technology.
    Comment: Some commenters stated support for the proposed SPADEs, 
but noted reservations that the SPADEs aren't sufficient to address all 
areas of assessment. One commenter described the SPADEs as an 
appropriate start, but noted that the SPADEs cannot stand alone, and 
must be built upon in order to be useful for risk adjustment and 
quality measurement.
    Response: We believe that the SPADEs as proposed represent an 
important core set of information about clinical status and patient 
characteristics that may be used for risk adjustment. Additionally, we 
will continue to assess the use of the SPADES across our PAC settings, 
including the feasibility, reliability, validity and usability of the 
data elements in future risk adjustment models and quality measures. We 
also welcome continued input, recommendations, and feedback from 
stakeholders about ways to improve assessment and quality measurement 
for PAC providers, including ways that the SPADEs could be used in the 
HH QRP. Input can be shared with CMS through our PAC Quality 
Initiatives email address [email protected].

H. 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.\96\ 
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,\97\ and because these assessments provide 
opportunity for improving quality of care.
---------------------------------------------------------------------------

    \96\ 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.
    \97\ 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,98 99 
100 and promising treatments for severe traumatic brain 
injury are currently being tested.\101\ For older patients and 
residents diagnosed with depression, treatment options to reduce 
symptoms and improve quality of life include antidepressant medication 
and psychotherapy,102 103 104 
105 and targeted services, such as therapeutic recreation, 
exercise, and restorative nursing, to increase opportunities for 
psychosocial interaction.\106\
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    \98\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for 
Alzheimer's Disease: Are They Effective? Pharmacology & 
Therapeutics, 35, 208-11.
    \99\ 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.
    \100\ 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.
    \101\ 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.
    \102\ 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.
    \103\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined 
psychotherapy/pharmacotherapy for late life depression. Biological 
Psychiatry, 52(3), 293-303.
    \104\ 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.
    \105\ 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.
    \106\ 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;

[[Page 60569]]

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 final rule.
    We invited comment on our proposals to collect as standardized 
patient assessment data the following data with respect to cognitive 
function and mental status. Commenters submitted the following comments 
related to the proposed rule's discussion of the cognitive function and 
mental status data elements.
    Comment: A number of commenters supported the proposed use of the 
BIMS and CAM, but also raised concerns with the lack of sensitivity of 
these assessments for identifying mild to moderate cognitive impairment 
that can impact performance of activities of daily living (ADLs).
    Response: We acknowledge the limitations of the proposed SPADEs to 
fully assess all areas of cognition and mental status. We strived to 
balance the scope and level of detail of the data elements against the 
potential burden placed on patients and providers. In our past work, we 
evaluated the potential of several different cognition assessments for 
use as standardized data elements in PAC settings. We ultimately 
decided on the data elements in our proposal as a starting point, and 
we welcome continued input, recommendations, and feedback from 
stakeholders about additional data elements for standardization, which 
can be shared with CMS through our PAC Quality Initiatives email 
address: [email protected].
    Comment: Another provider recommended supplementing the BIMS and 
CAM specifically with the Development of Outpatient Therapy Payment 
Alternatives (DOTPA) items for post-acute assessments. They suggest 
that DOTPA items, coupled with a functional screen to detect practical 
problems, need to be administered during PAC assessments.
    Response: We evaluated the suitability of the DOTPA, as well as 
other screening tools that targeted functional cognition, by engaging 
our TEP, through ``alpha'' feasibility testing, and through soliciting 
input from stakeholders. At the second TEP meeting in March 2017, 
members questioned the use of data elements that rely on assessor 
observation and judgment, such as DOTPA CARE tool items, and favored 
other assessments of cognition that required patient interview or 
patient actions. The TEP also discussed performance-based assessment of 
functional cognition. These are assessments that require patients to 
respond by completing a simulated task, such as ordering from a menu, 
or reading medication instructions and simulating the taking of 
medications, as required by the Performance Assessment of Self-Care 
Skills (PASS) items. In Alpha 2 feasibility testing, which was 
conducted between April and July 2017, we included a subset of items 
from the DOTPA as well as the PASS. Findings of that test identified 
several limitations of the DOTPA items for use as SPADEs, such as the 
length of time to administer (5 to 7 minutes). In addition, interrater 
reliability was highly variable among the DOTPA items, both overall and 
across settings, with some items showing very low agreement (as low as 
0.34) and others showing excellent agreement (as high as 0.81). 
Similarly, findings of the Alpha 2 feasibility test identified several 
limitations of the PASS for use as SPADEs. The PASS was relatively 
time-intensive to administer (also 5 to 7 minutes), many patients in 
HHAs needed assistance completing the PASS tasks, and missing data were 
prevalent. Unlike the DOTPA items, interrater reliability was 
consistently high overall for PASS (ranging from 0.78 to 0.92), but the 
high reliability was not deemed to outweigh fundamental feasibility 
concerns related to administration challenges. A summary report for the 
Alpha 2 feasibility testing titled ``Development and Maintenance of 
Standardized Cross Setting Patient Assessment Data for Post-Acute Care: 
Summary Report of Findings from Alpha 2 Pilot Testing'' is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Alpha-2-SPADE-Pilot-Summary-Document.pdf. While we received support for the 
DOTPA, PASS, and other assessments of functional cognition, commenters 
also raised concerns about the reliability of the DOTPA, given that it 
is based on staff evaluation, and the feasibility of the PASS, given 
that the simulated medication task requires props, such as a medication 
bottle with printed label and pill box, which may not be accessible in 
all settings.
    Based on the input from our TEP, results of alpha feasibility 
testing, and input from stakeholders, we decided to propose the BIMS 
for standardization at this time due to the body of research literature 
supporting its feasibility and validity, its relative brevity, and its 
existing use in the MDS and IRF-PAI.
a. Brief Interview for Mental Status (BIMS)
    In the CY 2020 HH PPS proposed rule (84 FR 34653 through 34654), we 
proposed 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.\107\ 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.\108\
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    \107\ 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.
    \108\ RTI International. Proposed Measure Specifications for 
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle 
Park, NC. 2016.
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    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

[[Page 60570]]

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. We stated in the 
proposed rule that more information about the performance of the BIMS 
in the National Beta Test could 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 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 proposed 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.
    We invited comment on our proposal to collect the BIMS as 
standardized patient assessment data. We did not receive additional 
comments specific to the BIMS. General comments on the category of 
Cognitive Function and Mental Status are discussed in section V.H.1 of 
this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the BIMS as 
standardized patient assessment data beginning with the CY 2022 HH QRP 
as proposed.
b. Confusion Assessment Method (CAM)
    In the CY 2020 HH PPS proposed rule (84 FR 34654 through 34655), we 
proposed 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

[[Page 60571]]

hospitalized older adults.\109\ Assessing these signs and symptoms of 
delirium is clinically relevant for care planning by PAC providers.
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    \109\ 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.
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    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 proposed 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, a 
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 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 proposed 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.
    We invited comment on our proposals to collect as standardized 
patient assessment data the following data with respect to the CAM. We 
did not receive any comments specific to the CAM. General comments on 
the category of Cognitive Function and Mental Status are discussed in 
section V.H.1 of this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the CAM data 
elements as standardized patient assessment data beginning with the CY 
2022 HH QRP as proposed.
c. Patient Health Questionnaire--2 to 9 (PHQ-2 to 9)
    In CY 2020 HH PPS proposed rule (84 FR 34655 through 34656), we 
proposed 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 in detail in this section of this final rule 
with comment period.
    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

[[Page 60572]]

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.110 111 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.
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    \110\ 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.
    \111\ 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.
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    Components of the proposed data elements are currently used in the 
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We proposed to add 
the additional data elements of the PHQ-9 to the OASIS to replace 
M1730, Depression Screening. We are proposed 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,\112\ 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.
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    \112\ 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.
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    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 information about the performance of the 
PHQ-2 to 9 in the National Beta Test can be found in the document 
titled, ``Final 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 proposed that the PHQ-2 to 9 data 
elements meet the definition of standardized patient assessment data 
with respect to

[[Page 60573]]

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.
    We invited comment on our proposals to collect as standardized 
patient assessment data the PHQ-2 to 9 data elements. We did not 
receive comments specific to the PHQ-2 to 9 data elements. General 
comments on this category of Cognitive Function and Mental Status are 
discussed in section V.H.1 of this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the PHQ-2 to 9 
data elements as standardized patient assessment data beginning with 
the CY 2022 HH QRP as proposed.
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. We did not propose to 
require a physician signature because the existing Conditions of 
Participation for HHAs 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 invited comment on our proposals to collect as standardized 
patient assessment data the following data with respect to special 
services, treatments, and interventions.
    Comment: A number of commenters questioned whether data elements in 
the SPADE category of Special Services, Treatments, and Interventions 
were applicable to home health, due to their low prevalence and that 
these data elements would place an undue burden on providers.
    Response: We appreciate the commenters' concern that clinical 
treatments or response categories documented by some SPADEs are 
uncommon overall and/or unlikely in the HH setting. We understand that 
not all SPADEs will be equally relevant to all patients and/or PAC 
providers. However, we assert that even relatively rare treatments or 
clinical situations, such as a patient undergoing chemotherapy while 
receiving PAC services, or having a feeding tube, are important to 
document, both for care planning within the setting and for transfer of 
information to the next setting of care. We note that the assessment of 
many of the less frequently occurring treatments and conditions is 
formatted as a ``check all that apply'' list, which minimizes burden. 
When treatments do not apply the assessor need only check one row for 
``None of the Above.''
a. Cancer Treatment: Chemotherapy (IV, Oral, Other)
    In CY 2020 HH PPS proposed rule (84 FR 34657 through 34658), we 
proposed 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

[[Page 60574]]

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, ``Final 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 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 proposed 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

[[Page 60575]]

to adopt the Chemotherapy (IV, Oral, Other) data element as 
standardized patient assessment data for use in the HH QRP.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Chemotherapy (IV, Oral, Other) data 
element.
    Comment: One commenter agreed that it is important to know if a 
patient is receiving chemotherapy for cancer and the method of 
administration, but also expressed concern about the lack of an 
association with a patient outcome. This commenter noted that 
implications of chemotherapy for patients needing speech-language 
pathology services include chemotherapy-related cognitive impairment, 
dysphagia, and speech- and voice-related deficits.
    Response: We appreciate the commenter's concern. We agree with the 
commenter that chemotherapy can create related treatment needs for 
patients, such as the examples noted by the commenter. However, we 
believe that it is not feasible for SPADEs to capture all of a 
patient's needs related to any given treatment, and we maintain that 
the Special Services, Treatments, and Interventions SPADEs provide a 
common foundation of clinical assessment, which can be built on by the 
individual provider or a patient's care team.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Chemotherapy (IV, Oral, Other) 
data element as standardized patient assessment data beginning with the 
CY 2022 HH QRP as proposed.
b. Cancer Treatment: Radiation
    In CY 2020 HH PPS proposed rule (84 FR 34658), we proposed 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, ``Final 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 proposed 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.

[[Page 60576]]

    We invited comment on our proposal to collect as standardized 
patient assessment data the Radiation data element.
    Comment: One commenter expressed concern that the radiation data 
element assesses whether a patient is receiving radiation for cancer 
treatment, but does not identify the rationale for and outcomes 
associated with radiation. The commenter noted that implications of 
radiation for patients needing speech-language pathology services 
include reduced head and neck range of motion due to radiation or 
severe fibrosis, scar bands, and reconstructive surgery complications 
and that these can impact both communication and swallowing abilities.
    Response: We appreciate the commenter's concern. We agree with the 
commenter that radiation can create related treatment needs for 
patients, such as the examples noted by the commenter. However, we 
believe that it is not feasible for SPADEs to capture all of a 
patient's needs related to any given treatment, and we maintain that 
the Special Services, Treatments, and Interventions SPADEs provide a 
common foundation of clinical assessment, which can be built on by the 
individual provider or a patient's care team.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Radiation data element as 
standardized patient assessment data beginning with the CY 2022 HH QRP 
as proposed.
c. Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous, 
High-Concentration Oxygen Delivery System)
    In CY 2020 HH PPS proposed rule (84 FR 34658 through 34659), we 
proposed 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 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 captures 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, ``Final 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, ``Final 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-

[[Page 60577]]

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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Oxygen Therapy data element. We did not 
receive any comments specific to the Oxygen Therapy data element. 
General comments on the category of Special Services, Treatments, and 
Interventions Data are discussed in section V.H.2 of this final rule 
with comment period.
    Accordingly, we are finalizing our proposal to adopt the Oxygen 
Therapy (Intermittent, Continuous, High-Concentration Oxygen Delivery 
System) data element as standardized patient assessment data beginning 
with the CY 2022 HH QRP as proposed.
d. Respiratory Treatment: Suctioning (Scheduled, As Needed)
    In CY 2020 HH PPS proposed rule (84 FR 34659 through 34661), we 
proposed 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 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

[[Page 60578]]

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, ``Final 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 proposed 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 adopt 
the Suctioning (Scheduled, As Needed) data element as standardized 
patient assessment data for use in the HH QRP.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Suctioning data element.
    Comment: One commenter requested that respiratory treatment--
suctioning data element also assess the frequency of suctioning, as it 
can impact resource utilization and potential medication changes in the 
plan of care.
    Response: We appreciate the commenter's feedback that the response 
options for this data element may not fully capture impacts to resource 
utilization and care plans. The Suctioning data element includes sub-
elements to identify if suctioning is performed on a ``Scheduled'' or 
``As Needed'' basis, but it does not directly assess the frequency of 
suctioning by, for example, asking an assessor to specify how often 
suctioning is scheduled. This data element differentiates between 
patients who only occasionally need suctioning and patients for whom 
assessment of suctioning needs is a frequent and routine part of the 
care (that is, where suctioning is performed on a schedule according to 
physician instructions). In our work to identify standardized patient 
assessment data elements, we have strived to balance the scope and 
level of detail of the data elements against the potential burden 
placed on patients and providers. We further clarify that any SPADE is 
intended as a minimum assessment and does not limit the ability of 
providers to conduct a more comprehensive evaluation of a patient's 
situation to identify the potential impacts on outcomes that the 
commenter describes.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Suctioning (Scheduled, As 
Needed) data element as standardized patient assessment data beginning 
with the CY 2022 HH QRP as proposed.
e. Respiratory Treatment: Tracheostomy Care
    In CY 2020 HH PPS proposed rule (84 FR 34661), we proposed 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

[[Page 60579]]

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, ``Final 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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Tracheostomy Care data element.
    Comment: A commenter, noted the importance of tracheostomy care and 
determining whether a patient is receiving tracheostomy care, as it 
helps with risk adjustment and identifying increased resource 
utilization. The commenter recommended that the SPADE be expanded to 
ask about the size of the tracheostomy and whether the tracheostomy has 
a cuff or is fenestrated.
    Response: Risk adjustment determinations is an issue that we 
continue to evaluate in all of our QRPs, including the HH QRP. We will 
note this issue for further analysis in our future work to determine 
how the SPADEs will be used. With regard to the commenter's request to 
expand the Tracheostomy Care SPADE to include more detail about the 
type of tracheostomy, we do not believe that this level of clinical 
detail is necessary to fulfill the purposes of the SPADEs, which are to 
support care coordination, care planning, and future quality measures. 
We believe the broad indication that a patient is receiving 
Tracheostomy Care will be sufficient for the purposes of 
standardization and quality measurement.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Tracheostomy Care data element 
as standardized patient assessment data beginning with the CY 2022 HH 
QRP as proposed.
f. Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP, 
CPAP)
    In CY 2020 HH PPS proposed rule (84 FR 34661 through 34662), we 
proposed 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 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, ``Final 
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-

[[Page 60580]]

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, ``Final 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 proposed 
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.
    We sought comment on our proposal to collect as standardized 
patient assessment data the Non-Invasive Mechanical Ventilator data 
element. We did not receive any comments specific to the Non-Invasive 
Mechanical Ventilator data element. General comments on the category of 
Special Services, Treatments, and Interventions Data are discussed in 
section V.H.2 of this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the Non-
invasive Mechanical Ventilator (BiPAP, CPAP) data element as 
standardized patient assessment data beginning with the CY 2022 HH QRP 
as proposed.
g. Respiratory Treatment: Invasive Mechanical Ventilator
    In CY 2020 HH PPS proposed rule (84 FR 34662 through 34663),we 
proposed 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.\113\
---------------------------------------------------------------------------

    \113\ 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.
---------------------------------------------------------------------------

    The proposed data element, Invasive Mechanical Ventilator, consists 
of a 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, ``Final 
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

[[Page 60581]]

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 proposed 
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.
    We invited comment on our proposals to collect as standardized 
patient assessment data the Invasive Mechanical Ventilator data 
element.
    Comment: One commenter expressed concern that the invasive 
mechanical ventilator element only assesses whether or not a patient is 
on a mechanicalventilator. The commenter suggested CMS consider 
collecting data to track functional outcomes related to progress 
towards independence in communication and swallowing.
    Response: In our evaluation of the suitability of data elements for 
SPADEs, we examined the clinical usefulness of candidate SPADEs across 
the full range of PAC providers, including HHAs. We intend to use the 
SPADEs to inform care planning and comparing of assessment data for 
standardized measures. We believe that assessing the use of an invasive 
mechanical ventilator is a useful point of information to inform care 
planning and further assessment, such as related to functional 
outcomes. We wish to clarify that the proposed SPADEs are not intended 
to replace comprehensive clinical evaluation and in no way preclude 
providers from conducting further patient evaluation or assessments in 
their settings as they believe are necessary and useful. However, we 
will take into consideration functional outcomes, overall, that are 
related to progress towards independence in communication and 
swallowing in future modifications.
    After careful consideration of the public comments we received, we 
are finalizing our proposal to adopt the Invasive Mechanical Ventilator 
data element as standardized patient assessment data beginning with the 
CY 2022 HH QRP as proposed.
h. Intravenous (IV) Medications (Antibiotics, Anticoagulants, 
Vasoactive Medications, Other)
    In CY 2020 HH PPS proposed rule (84 FR 34663 through 34664), we 
proposed 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

[[Page 60582]]

(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 of medication provided by each PAC provider will improve 
quality of care.
    The IV Medications (Antibiotics, Anticoagulants, Vasoactive 
Medications, and Other) data element we proposed 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 proposed 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.
    We sought public comment on our proposal to collect as standardized 
patient assessment data the IV Medications data element. We did not 
receive any comments specific to the IV Medications (Antibiotics, 
Anticoagulants, Vasoactive Medications, Other) data element. General 
comments on the category of Special Services, Treatments, and 
Interventions Data are

[[Page 60583]]

discussed in section V.H.2 of this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the IV 
Medications (Antibiotics, Anticoagulants, Vasoactive Medications, 
Other) data element as standardized patient assessment data beginning 
with the CY 2022 HH QRP as proposed.
i. Transfusions
    In CY 2020 HH PPS proposed rule (84 FR 34664 through 34665), we 
proposed 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 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 proposed 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.
    We invited public comment on our proposal to collect as 
standardized patient assessment data the Transfusions data element. We 
did not receive any comments specific to the Transfusions data element. 
General comments on the category of Special Services, Treatments, and 
Interventions Data are discussed in section V.H.2 of this final rule 
with comment period.
    Accordingly, we are finalizing our proposal to adopt the 
Transfusions data element as standardized patient assessment data 
beginning with the CY 2022 HH QRP as proposed.
j. Dialysis (Hemodialysis, Peritoneal Dialysis)
    In CY 2020 HH PPS proposed rule (84 FR 34655 through 34656), we 
proposed 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)

[[Page 60584]]

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 final rule with comment period, we proposed 
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 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 proposed 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 proposed 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.
    We invited public comment on our proposal to collect as 
standardized patient assessment data the Dialysis data element. We did 
not receive any comments specific to the Dialysis (Hemodialysis, 
Peritoneal Dialysis) data element. General comments on the category of 
Special Services, Treatments, and Interventions Data are discussed in 
section V.H.2 of this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the Dialysis 
(Hemodialysis, Peritoneal dialysis) data element as standardized 
patient assessment data beginning with the CY 2022 HH QRP as proposed.
k. Intravenous (IV) Access (Peripheral IV, Midline, Central Line)
    In CY 2020 HH PPS proposed rule (84 FR 34666 through 34667), we 
proposed 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.

[[Page 60585]]

    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 proposed 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 final rule with comment period, 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 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 proposed 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.
    We invited public comment on our proposal to collect as 
standardized patient assessment data the IV Access data element. We did 
not receive any comments specific to the IV Access (Peripheral IV, 
Midline, Central Line) data element. General comments on the category 
of Special Services, Treatments, and Interventions Data are discussed 
in section V.H.2 of this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the 
Intravenous (IV) Access (Peripheral IV, Midline, Central line) data 
element as standardized patient assessment data beginning with the CY 
2022 HH QRP as proposed.
l. Nutritional Approach: Parenteral/IV Feeding
    In CY 2020 HH PPS proposed rule (84 FR 345667 through 34668), we 
proposed that the Parenteral/IV Feeding data element meets the 
definition of standardized patient assessment data with respect to 
special services,

[[Page 60586]]

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 proposed 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-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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Parenteral/IV Feeding data element.
    Comment: One commenter was supportive of collecting the Parenteral/
IV Feeding data element, but noted that it should not be a substitute 
for capturing information related to swallowing which reflects 
additional patient complexity and resource use.
    Response: We agree that the Parenteral/IV Feeding SPADE should not 
be used as a substitute for an assessment of a patient's swallowing 
function. The proposed SPADEs are not intended to replace comprehensive 
clinical evaluation and in no way preclude providers from conducting 
further patient evaluation or assessments in their settings as they 
believe are necessary and useful. We agree that information related to 
swallowing can capture patient complexity. However, we also note that 
Parenteral/IV Feeding data element captures a different construct than 
an evaluation of swallowing. That is, the Parenteral/IV Feeding data 
element captures a patient's need to receive calories and nutrients 
intravenously, while an assessment of swallowing would capture a 
patient's functional ability to safely consume food/liquids orally for 
digestion in their gastrointestinal tract.
    After careful consideration of the public comment we received on 
the Parenteral/IV Feeding data element, we are finalizing our proposal 
to adopt the

[[Page 60587]]

Parenteral/IV Feeding data element as standardized patient assessment 
data beginning with the CY 2022 HH QRP as proposed.
m. Nutritional Approach: Feeding Tube
    In CY 2020 HH PPS proposed rule (84 FR 34668 through 34669), we 
proposed 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.\114\ 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).
---------------------------------------------------------------------------

    \114\ 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 proposed 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 proposed in the CY 2020 HH PPS proposed rule (84 
FR 34668), 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, ``Final 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-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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Feeding Tube data element.
    Comment: In regard to the nutritional approach--feeding tube data 
element, one commenter noted that in addition to identifying if the 
patient is on a feeding tube or not, it would be important to assess 
the patient's progression towards oral feeding within this data 
element, as this impacts the tube feeding regimen.
    Response: We agree that progression to oral feeding is important 
for care planning and transfer. We wish to clarify that the proposed 
SPADEs are

[[Page 60588]]

not intended to replace comprehensive clinical evaluation and in no way 
preclude providers from conducting further patient evaluation or 
assessments in their settings as they believe are necessary and useful. 
However, we will take this recommendation into consideration in future 
work on standardized data elements.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Feeding Tube data element as 
standardized patient assessment data beginning with the CY 2022 HH QRP 
as proposed.
n. Nutritional Approach: Mechanically Altered Diet
    In CY 2020 HH PPS proposed rule (84 FR 34669), we proposed 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.\115\
---------------------------------------------------------------------------

    \115\ 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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Mechanically Altered Diet data element.
    Comment: One commenter was concerned that the Mechanically Altered 
Diet data element does not capture clinical complexity and does not 
provide any insight into resource allocation because it only measures 
whether the patient needs a mechanically altered diet and not, for 
example, the extent of help a patient needs in consuming his or her 
meal.
    Response: We believe that assessing patients' needs for 
mechanically altered diets captures one piece of information about 
resource intensity. That is, patients with this special nutritional 
requirement may require additional nutritional planning services, 
special meals, and staff to ensure that meals are prepared and served 
in the way the patient needs. Additional factors that

[[Page 60589]]

would affect resource allocation, such as those noted by the commenter, 
are not captured by this data element. We have attempted to balance the 
scope and level of detail of the data elements against the potential 
burden placed on providers who must complete the assessment. We will 
take this suggestion into consideration in future refinement of the 
clinical SPADEs.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Mechanically Altered Diet data 
element as standardized patient assessment data beginning with the CY 
2022 HH QRP as proposed.
o. Nutritional Approach: Therapeutic Diet
    In CY 2020 HH PPS proposed rule (84 FR 34670), we proposed 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, ``Final 
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 proposed 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.
    We invited comment on our proposal to collect as standardize 
patient assessment data the Therapeutic Diet data element. We did not 
receive any additional comments specific to the Therapeutic Diet data 
element. General comments on the category of Special Services, 
Treatments, and Interventions Data are discussed in section V.H.2 of 
this final rule with comment period.
    Accordingly, we are finalizing our proposal to adopt the 
Therapeutic Diet data element as standardized patient assessment data 
beginning with the CY 2022 HH QRP as proposed.
p. High-Risk Drug Classes: Use and Indication
    In CY 2020 HH PPS proposed rule (84 FR 34670 through 34672), we 
proposed 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.\116\ 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

[[Page 60590]]

medication errors such as drug omissions, errors in dosage, and errors 
in dosing frequency.\117\
---------------------------------------------------------------------------

    \116\ 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.
    \117\ 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,\118\ while the rate of 
ADEs in the long-term care setting is approximately 9.80 ADEs per 100 
resident-months.\119\ In the hospital setting, the incidence has been 
estimated at 15 ADEs per 100 admissions.\120\ 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 from a hospital.121 122 123 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.\124\
---------------------------------------------------------------------------

    \118\ 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.
    \119\ 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.
    \120\ 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]
    \121\ Barnsteiner JH. Medication reconciliation: transfer of 
medication information across settings-keeping it free from error. J 
Infus Nurs. 2005;28(2 Suppl):31-36.
    \122\ Rozich J, Roger, R. Medication safety: one organization's 
approach to the challenge. Journal of Clinical Outcomes Management. 
2001(8):27-34.
    \123\ 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.
    \124\ 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.\125\ We proposed 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; 126 127 fluid retention, heart failure, and 
lactic acidosis are associated with hypoglycemics; \128\ misuse is 
associated with opioids;\129\ fractures and strokes are associated with 
antipsychotics; 130 131 and various adverse events such as 
central nervous systems effects and gastrointestinal intolerance are 
associated with antimicrobials,\132\ 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.\133\ 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.\134\
---------------------------------------------------------------------------

    \125\ Ibid.
    \126\ 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.
    \127\ 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.
    \128\ Hamnvik OP, McMahon GT. Balancing Risk and Benefit with 
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New 
York. 2009; 76:234-243.
    \129\ Naples JG, Gellad WF, Hanlon JT. The Role of Opioid 
Analgesics in Geriatric Pain Management. Clin Geriatr Med. 
2016;32(4):725-735.
    \130\ 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].
    \131\ 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.
    \132\ Faulkner CM, Cox HL, Williamson JC. Unique aspects of 
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
    \133\ 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.
    \134\ 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.

[[Page 60591]]

    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,\135\ 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.
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    \135\ 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.
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    We received public input on data elements related to medication 
reconciliation through a call for input published on the CMS Measures 
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, ''Final 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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the High-Risk Drug Classes: Use and Indication 
data element.
    Comment: One commenter raised the concern of assessing some high 
risk drug classes, noting that assessing each patient for use of 
opioids and antipsychotics could discourage appropriate use of these 
medications in those with advanced illness or receiving palliative 
care.
    Response: We acknowledge commenters' concerns about potential 
unintended consequences of limiting use of medications for patients 
with a clinical need. We remain confident that HHAs will continue to 
focus on appropriate management of pain and mental health issues for 
all patients as part of their commitment to quality of care and ongoing 
quality improvement efforts. CMS is also committed to monitor incoming 
assessment data related to pain for unintended consequences and will be 
prepared to take necessary steps based on monitoring findings.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the

[[Page 60592]]

High-Risk Drug Classes: Use and Indication data element as standardized 
patient assessment data beginning with the CY 2022 HH QRP as proposed.
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.\136\ 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.\137\ 
\138\ \139\
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    \136\ 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
    \137\ 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
    \138\ 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.
    \139\ 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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    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 invited 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 sought 
comment on whether or not we should add these pain items in light of 
those concerns. Commenters were asked to address to what extent 
collection of the data through patient queries might encourage 
providers to prescribe opioids.
    In CY 2020 HH PPS proposed rule (84 FR 34673 through 34675), we 
proposed 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.\140\ 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.\141\ 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.\142\
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    \140\ Institute of Medicine. Relieving Pain in America: A 
Blueprint for Transforming Prevention, Care, Education, and 
Research. Washington (DC): National Academies Press (US); 2011. 
https://www.ncbi.nlm.nih.gov/books/NBK91497/.
    \141\ 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.
    \142\ 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.
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    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.\143\ 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

[[Page 60593]]

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.
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    \143\ National Pain Strategy: A Comprehensive Population-Health 
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
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    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 final rule with comment period we have also proposed a 
SPADE in section V.H.2.p. of this rule that assess for the use of, as 
well as importantly the indication for the 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.\144\ 
\145\ \146\ 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.\147\ \148\ \149\
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    \144\ 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.
    \145\ Fine, P.G. (2009). Chronic Pain Management in Older 
Adults: Special Considerations. Journal of Pain and Symptom 
Management, 38(2): S4-S14.
    \146\ 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.
    \147\ 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.
    \148\ 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.
    \149\ 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, 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,\150\ and consistent with HHS's 5-Point Strategy To Combat the 
Opioid Crisis \151\ which includes ``Better Pain Management.''
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    \150\ Society for Post-Acute and Long-Term Care Medicine (AMDA). 
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
    \151\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/.
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    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 
proposed 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

[[Page 60594]]

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 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 proposed 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.
    We invited comment on our proposal and received the following 
comments related to our proposal to adopt the Pain Interference (Pain 
Effect on Sleep, Pain Interference with Therapy Activities, and Pain 
Interference with Day-to-Day Activities) data elements.
    Comment: Some commenters noted specific support for the 
introduction of the new pain data elements that can assist providers in 
care planning.
    Response: CMS thanks commenters for their support of the pain 
interference data elements. 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.
    Comment: A commenter expressed concerns about the suitability of 
the Pain Interference data elements for use in patients with cognitive 
and communication deficits and recommended CMS consider the use of non-
verbal means to allow patients to respond to SPADEs related to pain.
    Response: We appreciate the commenter's concern surrounding pain 
assessment with patients with cognitive and communication deficits. The 
Pain Interference interview SPADEs require that a patient be able to 
communicate, whether verbally, in writing, or using another method. 
Assessors may use non-verbal means to administer the questions (for 
example, providing the questions and response in writing for a patient 
with severe hearing impairment). Patients who are unable to communicate 
by any means would not be required to complete the Pain Interference 
interview SPADEs. In addition, we note that evidence suggests that pain 
presence can be reliably assessed in non-communicative patients through 
structural observational protocols. To that end, we tested 
observational pain presence elements in the National Beta Test, but 
chose not to propose those data elements as SPADEs at this time. We 
will take the commenter's concern into consideration as the SPADEs are 
monitored and refined in the future.
    After careful consideration of the public comments we received, we 
are finalizing our proposal to adopt the Pain Interference (Pain Effect 
on Sleep, Pain Interference with Therapy Activities, and Pain 
Interference with Day-to-Day Activities) data elements as standardized 
patient assessment data beginning with the CY 2022 HH QRP as proposed.
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

[[Page 60595]]

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.\152\
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    \152\ 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/, and https://www.hhs.gov/civil-rights/for-individuals/section-1557/.
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    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 invited comment on our proposals to collect as standardized 
patient assessment data the Hearing and Vision data elements with 
respect to impairments.
a. Hearing
    In CY 2020 HH PPS proposed rule (84 FR 34675 through 34676), we 
proposed 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.153 154 Treatment and accommodation of hearing 
impairment led to improved health outcomes, including but not limited 
to quality of life. \155\ For example, hearing loss in elderly 
individuals has been associated with depression and cognitive 
impairment,156 157 158 higher rates of incident cognitive 
impairment and cognitive decline,\159\ and less time in occupational 
therapy.\160\ Accurate assessment of hearing impairment is important in 
the PAC setting for care planning and defining resource use.
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    \153\ 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.
    \154\ 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.
    \155\ 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.
    \156\ 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.
    \157\ 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.
    \158\ 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.
    \159\ 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.
    \160\ 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.
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    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 
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

[[Page 60596]]

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 
proposed 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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Hearing data element.
    Comment: With regard to the hearing data element, one commenter 
suggested that CMS consider how hearing impairment impacts a patient's 
ability to respond to the assessment tool in general.
    Response: We intend to reinforce assessment tips and item rationale 
through training, open door forums, and future rulemaking efforts. In 
the existing guidance manual for the OASIS, we offer tips for 
administration that direct assessors to take appropriate steps to 
accommodate sensory and communication impairments when conducting the 
assessment.
    After careful consideration of the public comment we received, we 
are finalizing our proposal to adopt the Hearing data element as 
standardized patient assessment data beginning with the CY 2022 HH QRP 
as proposed.
b. Vision
    In CY 2020 HH PPS proposed rule (84 FR 34676 through 35677), we 
proposed 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.161 
162 163 164 165 
166 167 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.
---------------------------------------------------------------------------

    \161\ 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.
    \162\ 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.
    \163\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh. 
2004;36(1):79-85.
    \164\ 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.
    \165\ 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.
    \166\ Rovner BW, Ganguli M. Depression and disability associated 
with impaired vision: The MoVies Project. J Am Geriatr Soc. 
1998;46(5):617-619.
    \167\ 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.
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    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 proposed 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 proposed 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 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

[[Page 60597]]

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-ownloads-and-Videos.html.
    Due to the relatively stable nature of vision impairment, we 
proposed 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 proposed 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.
    We invited comment on our proposal to collect as standardized 
patient assessment data the Vision data element. We did not receive any 
comments on this category of impairment data or on the Vision data 
element.
    Accordingly, we are finalizing our proposal to adopt the Vision 
data element as standardized patient assessment data beginning with the 
CY 2022 HH QRP as proposed.
5. New Category: Social Determinants of Health
a. 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 final rule with comment period) 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 
proposed 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 the CY 2020 HH PPS proposed rule (84 FR 34677 through 34684), we 
proposed 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 final rule with comment period. 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 
proposed to collect information on seven proposed SDOH SPADE data 
elements relating to race, ethnicity, preferred language, interpreter 
services, health literacy, transportation, and social isolation; a 
detailed discussion of each of the proposed SDOH data

[[Page 60598]]

elements is found in section IV.A.7.f.(ii). of this final rule with 
comment period.
    We also proposed 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 
final rule with comment period. 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 final rule with 
comment period, 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 final, 
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.'' \168\ 
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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    \168\ 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.
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    Each of the data elements we proposed 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.\169\
---------------------------------------------------------------------------

    \169\ 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.\170\ 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.
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    \170\ 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.
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    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 suggested a three-pronged strategy to

[[Page 60599]]

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 proposed 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 final rule with comment period, under section 
2(d)(2) of the IMPACT Act, would be independent of our proposal 
discussed in this final rule with comment period in section 
IV.A.7.f.(2). of the preamble of this final rule with comment period 
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 proposed 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 final rule with 
comment period; (2) Ethnicity, described in section V.G.5.b.(1). of 
this final rule with comment period; (3) Preferred Language, as 
described in section V.G.5.(ii).(2). of this final rule with comment 
period; (4) Interpreter Services, as described in section V.G.5.b.(2). 
of this final rule with comment period; (5) Health Literacy, as 
described in section V.G.5.b.(3). of this final rule with comment 
period; (6) Transportation, as described in section V.G.5.(ii).(4). of 
this final rule with comment period; and (7) Social Isolation, as 
described in section V.G.5.b.(5). of this final rule with comment 
period. 84 FR 34677 through 34684. These data elements are discussed in 
more detail in section V.G.5. of this final rule with comment period.
    Comment: One commenter noted that CMS did not state explicitly in 
the rule whether it anticipates the SDOH SPADEs will be used in 
adjusting measures and whether it believes that the IMPACT Act's 
requirements make it likely the SPADEs will be considered for use in 
future adjustments. The commenters recommended that CMS be circumspect 
and transparent in its approaches to incorporating the data elements 
proposed in payment and quality adjustments, such as by collecting 
stakeholder feedback before implementing any adjustments.
    Response: We thank the commenter for their comment. We intend to 
use this data to assess the impact that the social determinants of 
health have on health outcomes. We will continue to work with 
stakeholders to promote transparency and support providers who serve 
vulnerable populations, promote high quality care, and refine and 
further implement SDOH SPADEs. We appreciate the comment on collecting 
stakeholder feedback before implementing any adjustments to measures 
based on the SDOH SPADEs. Collection of this data will help us identify 
potential disparities, conduct analyses, and assess whether any risk 
adjustments or other type of adjustments are needed. Any future policy 
development based on this data would be done transparently, and involve 
solicitation of stakeholder feedback through the notice and comment 
rulemaking process as appropriate.
    Comment: Some commenters stated that the inclusion of the new 
proposed SPADEs, including SDOH data elements, will be burdensome for 
providers and agencies to implement. Commenters stated that CMS should 
explore obtaining this data through Medicare claims. They suggested 
that the agency should explain why certain data elements can only be 
obtained through OASIS and other patient assessment tools, rather than 
through other means, and asked that CMS lay out a multi-year plan for 
implementation because the current proposal for implementation is not 
feasible. The commenters suggested that CMS consider reducing the 
number of SDOH SPADE metrics to ensure questions and overall categories 
do not create an undue burden and that the new SPADE measures be 
transitioned by category in a stepwise fashion, allowing achievement of 
the IMPACT Act requirements while interoperability continues to be 
strengthened. They also urged CMS to consider a two-year voluntary 
submission period when additional SPADEs are adopted into the HH QRP to 
allow for vendor development, facility integration, and staff training, 
and recommended that CMS provides funding and administrative support 
for standardizing electronic medical records to ensure effective 
operability across all post-acute sites.
    Response: We thank the commenters for their comments, and we agree 
that it is important to to minimize burden on providers. Under 
subsections (A) and (C) of section 2(d)(2, the IMPACT Act requires that 
CMS periodically 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

[[Page 60600]]

(c) and (d) of section 1899B of the Act and to other measures under 
Medicare. However, as stated above in this section, 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, 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. We 
will collect this SDOH data under the authority of subsection (B) of 
section 2(d)(2) to obtain this level of detail. We will provide 
technical assistance to organizations as they implement these 
requirements and believe that the implementation timeline we proposed 
and are finalizing in this rule is sufficient because some of the data 
elements required may have already been collected by HHAs.
    Comment: A few commenters noted concerns that the expanded 
comprehensive assessment added documentation and that the length of 
time it will take their clinicians to collect this data would be 
burdensome. The commenters stated that CMS should not add additional 
documentation burden to clinicians that add little value to patients or 
agencies who provide skilled home health services. They stated that CMS 
should not require agencies to collect SDOH data, which agencies have 
no ability to address or impact because it only increases time, cost, 
and frustration for patients and clinicians during the start of care 
while CMS intends to decrease cash flow during the same period.
    Response: We thank the commenters for their comments. We are 
mindful of the increased obligation that is required though this 
additional data collection. However, this data collection is highly 
valuable. 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. 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 use, and other 
measures, as required by section 2(d)(2) of the IMPACT Act, and to 
assess appropriate adjustments.
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. In the CY 2020 HH PPS proposed rule (84 FR 34679) we 
proposed 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 
also proposed 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 proposed 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 proposed 
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 proposed 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 final rule with comment period, we proposed 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 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.
    We solicited comment on these proposals and received the following 
comments. A discussion of these comments, along with our responses, 
appears in this section of this final rule with comment period.
    Comment: Several commenters supported the inclusion of the seven 
proposed SDOH data elements, ``race, ethnicity, preferred language, 
interpreter services, health literacy, transportation, and social 
isolation'' as data elements collected by HHAs. A commenter noted that 
this supports the increasing attention on the critical role that social 
factors place in individual and population health and the growing body 
of evidence that shows addressing health-related social needs through 
enhanced clinical-community linkages can improve health outcomes and 
reduce costs. Another commenter stated that there are gaps in assessing 
SDOH and they appreciate the considerable

[[Page 60601]]

time and energy that CMS has invested to develop these SPADEs.
    Response: We thank the commenters for their support, and we agree 
that collecting SDOH data elements can be useful in identifying and 
addressing health disparities.
    Comment: A few commenters expressed support for moving toward 
population health and outcomes through the SDOH SPADEs, requested 
clarification as to what the data will be used for, and inquired 
whether the data is already collected in other manners.
    Response: We thank the commenters for the feedback. We proposed the 
collection of SDOH SPADEs as part of the requirements outlined in 
section 1899B(b)(1) of the Act, and more specifically under the 
category of standardized patient assessment data that we specified 
under section 1899B(b)(1)(B)(vi) of the Act. SDOH data for home health 
beneficiaries is not systematically available for home health providers 
at this time. Collection of this data will enhance patient care, 
interoperability, and coordinated care. The availability of 
standardized data through this collection allows for common standards 
and definitions to be used among the providers, thus ensuring 
interoperable exchange in longitudinal information between post-acute 
care providers and other providers. Additionally, standardizing the 
collection of SDOH SPADES will allow providers to have a better 
understanding of individual patient's risk factors and treatment 
preferences, to facilitate better coordinated care and care planning 
for their patients, and to monitor for improvements in patient 
outcomes. Further, we are collecting these new SDOH SPADE data elements 
under the authority of section 2(d)(2) of the IMPACT ACT in order 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.
    Comment: Several commenters supported the inclusion of the seven 
proposed SDOH data elements in the OASIS assessment instrument, as HHAs 
serve populations affected by social determinants, but recommend 
including additional factors within the SDOH SPADE category to ensure 
that the full spectrum of social needs is examined. One commenter 
suggested evaluating the abilities of the caregiver to support the 
patient's care needs since any deficit could pose a risk to the health 
and safety of the patient with advanced illness. A few other commenters 
suggested that CMS consider adding level of education, food insecurity, 
and the ability to secure medications to the SDOH assessment. Several 
commenters stated that collecting sexual orientation and gender 
identity data alongside the SDOH data elements is important in post-
acute care because sexual and gender minorities experience unique 
cultural and environmental factors, including discrimination and 
stigma, which can negatively affect access to elder services, health 
services and health outcomes, and these identities also intersect with 
the proposed SDOH data elements in unique ways that can create 
additional barriers to care.
    Response: We thank the commenters for the comments and agree that 
SDOH should include a wide and ever-changing array of elements. In 
considering which SDOH we proposed to collect, we balanced our policy 
objective to collect SPADES that will inform care planning and 
coordination and quality improvement across care settings with the 
reporting burden for PAC providers. 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, National Academics of Sciences, Engineering, and Medicine 
(NASEM), Protocol for Responding to and Assessing Patients' Assets, 
Risks, and Experiences (PRAPARE), and ICD-10). We also engaged in 
discussions with stakeholders. Ultimately, we decided to propose SDOH 
SPADE data elements, some of which were identified in the 2016 NASEM 
report, which was commissioned by Office of the Assistant Secretary for 
Planning and Evaluation (ASPE). We will take the commenters' suggestion 
to include additional or different SDOH under advisement as we continue 
to improve and refine the SPADEs.
    Comment: One commenter noted that it is unknown what the most 
useful social risk data to collect is, and that collecting a 
comprehensive record comes with significant administrative burden. They 
support transforming general data collection categories into more 
discrete data points that can be analyzed and aggregated for 
programmatic strategies. They encouraged CMS to be mindful of 
meaningful collection and the potential for data overload as well as 
the ability to leverage existing data sources from across care 
settings. Since SDOH have impacts far beyond the post-acute care (PAC) 
setting, they cautioned CMS not to require data collection that cannot 
be readily gathered, shared or replicated beyond the PAC setting. For 
healthcare settings that have more established EHRs, the collection of 
SDOH should be aligned and associated costs for gathering, sharing or 
replicating considered. They also encouraged CMS to consider leveraging 
data points from primary care visits and urged CMS to take a holistic 
view of SDOH across the care continuum so that all care settings may 
gather, collect or leverage this data efficiently and so that the 
collection will yield the utmost impact.
    Response: We thank the commenter for the comment, and we agree that 
collecting SDOH data elements can be useful in identifying and 
addressing health disparities. We also agree with the feedback that we 
should be mindful of meaningful collection of SDOH data collection 
efforts so that data elements that are selected are useful. This is one 
of the reasons why we proposed SDOH SPADE data elements that were 
identified in the 2016 National Academies of Sciences, Engineering, and 
Medicine (NASEM) report, which was commissioned by the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE). Regarding the 
commenter's suggestion that we consider how it can align existing and 
future SDOH data elements to minimize burden on providers, we agree 
that it is important to minimize duplication efforts and align data 
collection as appropriate and to the extent possible, and will take 
this under advisement for future consideration. We also intend to 
solicit on the issue of whether we should collect SDOH data in other 
health care settings.
(1) Race and Ethnicity
    The persistence of racial and ethnic disparities in health and 
health care is widely documented, including in PAC 
settings.171 172 173 174 
175 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

[[Page 60602]]

Disparities Reports, consistently indicates that racial and ethnic 
disparities persist, even after controlling for factors such as income, 
geography, and insurance.\176\ 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.\177\ Studies have also shown 
that African Americans are significantly more likely than white 
Americans to die prematurely from heart disease and stroke.\178\ 
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.\179\
---------------------------------------------------------------------------

    \171\ 2017 National Healthcare Quality and Disparities Report. 
Rockville, MD: Agency for Healthcare Research and Quality; September 
2018. AHRQ Pub. No. 18-0033-EF.
    \172\ 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.
    \173\ 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.
    \174\ 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.
    \175\ 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.
    \176\ National Healthcare Quality and Disparities Reports. 
(December 2018). Agency for Healthcare Research and Quality, 
Rockville, MD. https://www.ahrq.gov/research/findings/nhqrdr/.
    \177\ National Center for Health Statistics. Health, United 
States, 2017: With special feature on mortality. Hyattsville, 
Maryland. 2018.
    \178\ HHS. Heart disease and African Americans. 2016b. (October 
24, 2016). https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
    \179\ 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/.
---------------------------------------------------------------------------

    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.\180\ 
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.
---------------------------------------------------------------------------

    \180\ ``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.
---------------------------------------------------------------------------

    In the CY 2020 HH PPS proposed rule (84 FR 34680 through 34681), we 
proposed 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 proposed 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 
proposed 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 proposed 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 current race/ethnicity data element included in MDS, LCDS, 
IRF-PAI, and OASIS.181 182 183 184 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.\185\ Standardizing self-reported data 
collection for race and ethnicity allows for the equal comparison of 
data across multiple healthcare entities.\186\ By collecting and

[[Page 60603]]

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

    \181\ 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.
    \182\ 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.
    \183\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
    \184\ ``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.
    \185\ 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/.
    \186\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    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 proposed to adopt the Race and Ethnicity data elements 
described previously as SPADEs with respect to the proposed Social 
Determinants of Health category.
    Specifically, we proposed 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 proposed 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.
    We solicited comment on these proposals.
    Commenters submitted the following comments related to the proposed 
rule's discussion of the Race and Ethnicity SPADEs. A discussion of 
these comments, along with our responses, appears in this section of 
this final rule with comment period.
    Comment: A few commenters questioned the response options for race. 
One commenter noted that the response options for race do not align 
with those used in other government data, such as the U.S. Census or 
the Office of Management and Budget (OMB). Some of the commenters also 
stated these responses are not consistent with the recommendations made 
in the 2009 NAESM (formerly Institute of Medicine) report. One 
commenter pointed out that the report recommended using broader OMB 
race categories and granular ethnicities chosen from a national 
standard set that can be ``rolled up'' into the broader categories. The 
commenters stated that it is unclear how CMS chose the 14 response 
options under the race data element and the five options under the 
ethnicity element and worried that these response options would add to 
the confusion that already may exist for patients about what terms like 
``race'' and ``ethnicity'' mean for the purposes of health care data 
collection. The commenter also noted that CMS should confer directly 
with experts in the issue to ensure patient assessments are collecting 
the right data in the right way before these SDOH SPADEs are finalized. 
Another commenter noted that the response options for race may not 
include all races that should be reflected, such as Native African and 
Middle Eastern. The commenter stated that the item should include 
``check all that apply.'' They encouraged CMS to provide rationale for 
the finalized list of response options. A commenter also urged CMS to 
review the Race/Ethnicity options to ensure they align with the 
www.wh.gov definitions as they are requirements for the Consolidated-
Clinical Document Architecture (C-CDA) and referenced in the US Core 
Data for Interoperability (USCDI). They pointed out that the SDOH 
elements will need to align options with the current Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) requirements and 
other data reporting requirements, reducing burden for providers to 
gather this information in multiple locations. The commenter stated 
that this alignment is imperative to ensure data elements are 
referenced from a single source of data entry for use across multiple 
data reporting requirements and that this careful review will help 
avoid administrative burdens.
    Response: We agree that data elements used by CMS should, to the 
extent possible, cross-reference with those used by other agencies. The 
proposed race and ethnicity categories align with and are rolled up 
into the 1997 OMB minimum data standards and conforming with the 2011 
HHS Data Standards at https://aspe.hhs.gov/basic-report/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-and-disability-status. The race and ethnicity data 
element that we proposed also includes ``Check all that apply'' 
language. As provided in the rationale of the proposed rule (84 FR 
34680 through 34681), the 14 race categories and the 5 ethnicity 
categories conform with the 2011 HHS Data Standards for person-level 
data collection, which were developed in fulfillment of section 4302 of 
the Affordable Care Act that required the Secretary of HHS to establish 
data collection standards for race, ethnicity, sex, primary language, 
and disability status.
    The Section 4302 Standards Workgroup was formed through the HHS 
Data Council, which is the principal, senior internal Departmental 
forum and advisory body to the Secretary on health and human services 
data policy and which coordinates HHS data collection and analysis 
activities. The Workgroup included representatives from HHS, the OMB, 
and the Census Bureau. The Workgroup examined current federal data 
collection standards, adequacy of prior testing, and quality of the 
data produced in prior surveys; consulted with statistical agencies and 
programs; reviewed OMB data collection standards and the 2009 Institute 
of Medicine report Race, Ethnicity, and Language Data: Standardization 
for Health Care Quality Improvement; sought input from national 
experts; and built on its members' experience with collecting and 
analyzing demographic data. As a result of this Workgroup, a set of 
data collection standards were developed, and then published for public 
comment. This set of data collection standards is referred to as the 
2011 HHS Data Standards (https://aspe.hhs.gov/basic-report/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-and-disability-status). The categories of race and 
ethnicity under the 2011 HHS Data Standards allow for more detailed 
information to be collected and the additional categories under the 
2011 HHS Data Standards can be aggregated into the OMB minimum 
standards set of categories. As noted in the proposed rule, we 
conducted a listening session regarding the proposed SDOH data elements 
regarding 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

[[Page 60604]]

included in the 2011 HHS Data Standards to better reflect state and 
local diversity.
    Regarding the commenter who urged CMS to review the proposed race 
and ethnicity elements to ensure they align with the www.wh.gov 
definitions, we believe the commenter may be referring to the 1997 OMB 
minimum data standards as the White House's definitions. If so, then as 
provided earlier in this response, the race and ethnicity categories 
that were proposed do align with and are rolled up into the 1997 OMB 
minimum data standards, which also align with CAHPS reporting 
requirements.
    Comment: One commenter stated that the degree of detail required 
for the social determinants of health sections A1005 ethnicity (focus 
on Hispanic, Latino/and Spanish origin) and A1010 race may be regarded 
as intrusive and offensive to patients. This could potentially cause 
refusal of home care or affect the provider-patient relationship and 
patient satisfaction.
    Response: We thank the commenter for their comment. 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. 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 use, and other measures, as required by 
section 2(d)(2) of the IMPACT Act, and to assess appropriate 
adjustments. Moreover, collection of race and ethnicity data, along 
with the other SDOH data elements, contributes to higher quality 
patient outcomes due to the ability to use the standardized, 
interoperable data to facilitate coordinated care and improved patient 
outcomes. Collection of data for these purposes is authorized under 
1899B(a)(1)(B). With the high value of collecting this data in mind, we 
do acknowledge the commenter's concerns about the potential for 
patients to view the collection of this data as intrusive and 
offensive, leading to service refusal or damaging the provide-patient 
relationship and patient satisfaction. We will monitor the 
implementation of these new data elements and modify the rule as 
appropriate.
    Providers are required to ask patients for responses to every SPADE 
data element question required in this rule for the HH QRP, including 
every SDOH SPADE question. However, patients are not required to 
respond to any of the SDOH SPADE questions. If the patient declines to 
or is unable to answer an SDOH SPADE question, the provider must 
indicate this non-response in the documentation. Therefore, we believe 
that the patient's wishes and concerns about privacy and whether the 
question is intrusive are respected and adequately protected under this 
policy.
(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).\187\ Individuals with LEP have been shown to 
receive worse care and have poorer health outcomes, including higher 
readmission rates.188 189 190 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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    \187\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
    \188\ 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.
    \189\ 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.
    \190\ 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.\191\
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    \191\ 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 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

[[Page 60605]]

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.\192\ 
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 proposed 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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    \192\ 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.
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    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 ``Final Specifications for HH QRP Measures and 
SPADEs,'' 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 
proposed 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.
    Comment: Some commenters noted that preferred language, need for an 
interpreter, access to transportation, and social isolation are 
unlikely to change between admission and discharge. One commenter 
disagrees with CMS's statement in the SNF, IRF and LTCH PPS FY 2020 
final rules that ``[patient] circumstances may have changed over the 
duration of their admission,'' and might change the answers to the 
health literacy, access to transportation and social isolation items. 
They acknowledge that for the SNF, IRF, and LTCH QRPs, CMS will allow 
providers to collect the Language Preference and Interpreter Services 
at just admission and they felt that CMS should do the same for other 
SDOH SPADES and just require that they be collected at admission. For 
example, they noted that Health Literacy is the degree to which 
individuals have the capacity to obtain, process, and understand basic 
health information and services needed to make appropriate health 
decisions, and it is difficult to see how these elemental skills would 
change over the course of a month-long HH episode. Thus, they 
encouraged CMS to only require collection of all SDOH SPADEs with 
respect to admission only.
    Response: We thank the commenters for their comments. We agree that 
Preferred Language and Interpreter Services should just be collected at 
admission given that a patient's response is unlikely to change. We 
disagree with the commenters that Health Literacy, Transportation and 
Social Isolation are unlikely to change from admission to discharge. 
Unlike the Vision, Hearing, Race, Ethnicity, Preferred Language, and 
Interpreter Services SPADEs, we believe that the response to this data 
element is likely to change from admission to discharge for some 
patients. For example, some patients may develop health issues, such as 
cognitive decline, during their stay that could impact their response 
to health literacy thus changing their status at discharge. Cognitive 
decline can impact a patient's ability to process and understand health 
information. Similarly, losing a loved one or caregiver, which can 
happen at any time, could impact someone's response on social isolation 
and access to transportation. It is common for caregivers to provide 
emotional support and access to transportation for those for those that 
they provide caregiving. Therefore, we are finalizing that the 
Preferred Language and Interpreter Services data elements would just be 
collected at admission, which will align with the collection of those 
elements in the IRF, SNF, and LTCH QRPs. We refer the reader to section 
V.L of this final rule with comment period, where we discuss the 
collection points for other SDOH SPADEs. For Health Literacy, 
Transportation, and Social Isolation, we are finalizing that these 
elements be collected upon admission and discharge, as described in 
these sections of this final rule with comment period.
(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.'' \193\ 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.\194\
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    \193\ 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.
    \194\ 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.\195\ 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

[[Page 60606]]

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.\196\ 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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    \195\ Social Determinants of Health. Healthy People 2020. 
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
    \196\ 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.197 198 The S-TOFHLA is a more 
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.\199\ Furthermore, the S-TOFHLA instrument is 
proprietary and subject to purchase for individual entities or 
users.\200\ 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 proposed 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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    \197\ 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.
    \198\ 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.
    \199\ 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/.
    \200\ Nurss, J.R., Parker, R.M., Williams, M.V., &Baker, D.W. 
David W. (2001). TOFHLA. Peppercorn Books & Press. Available from: 
https://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.\201\ 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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    \201\ 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.
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    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.\202\ For more information on the proposed Health Literacy 
data element, we refer readers to the document titled ``Proposed 
Specifications for HH QRP Measures and SPADEs,'' 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.
---------------------------------------------------------------------------

    \202\ 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 
proposed to adopt the SILS question, described previously for the 
Health Literacy data element, as SPADE under the Social Determinants of 
Health category. We proposed to add the Health Literacy data element to 
the OASIS. We solicited comment on this proposal. A discussion of the 
comment, along with our response, appears in this of this final rule 
with comment period.
    Comment: One commenter stated that the health literacy question 
could be improved to capture whether the patient can read, understand, 
and implement/respond to the information. In addition, the commenter 
stated that the question does not take into account whether a patient's 
need for help is due to limited vision, which is different from the 
purpose of the separate Vision Impairment data element. Another 
possible question the commenter suggested was ``How often do you have 
difficulty?'' The commenter suggested that a single construct may not 
be sufficient for this area, depending on the aspect of health literacy 
that CMS intends to identify.
    Response: We appreciate this commenter's suggestions. We proposed 
the Single Item Literacy Screener (SILS) to minimize burden and based 
on stakeholder feedback. We also conducted a listening session 
regarding the proposed SDOH data elements regarding the importance of 
collecting health literacy as a component of health care assessments 
and the listening session stakeholders generally supported the SILS 
option. Regarding the potential impacts of impaired vision, we do want 
to note that this rule adopts a vision data element that will be 
included on the OASIS instrument. The data on a patient's vision will 
be helpful with the health literacy question to gain a comprehensive 
picture of the patient's functioning.
(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.\203\ Access to

[[Page 60607]]

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 therefore proposed 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.
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    \203\ 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.
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    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 proposed 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.\204\
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    \204\ 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.
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    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.\205\ 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.\206\ 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 settings. As such, we 
proposed 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=https://www.nachc.org/prapare.
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    \205\ 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.
    \206\ 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 ``Final Specifications for HH 
QRP Measures and SPADEs,'' 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 
proposed 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.
    We solicited comment on this proposal. A discussion of the comment 
received, along with our responses appears in this section of this 
final rule with comment period.
    Comment: One commenter supported the collection of data to capture 
the reason(s) transportation affects a patient's access to health care. 
The commenter appreciated the inclusion of these items on the HHA and 
encouraged exploration of quality measures in this area as 
transportation is an extremely important instrumental activity of daily 
living to effectively transition to the community.
    Response: We thank the commenter for the comment and we will 
consider this feedback as we continue to improve and refine our quality 
measures.
(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.207 208 Social isolation tends to 
increase with age, is a risk factor for physical and mental illness, 
and a predictor of mortality.209 210 211 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

[[Page 60608]]

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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    \207\ 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.
    \208\ 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.
    \209\ 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.
    \210\ 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.
    \211\ 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 proposed 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.\212\ 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.
---------------------------------------------------------------------------

    \212\ 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 SPADEs,'' 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 proposed to adopt the Social Isolation data element 
described previously as SPADE with respect to the proposed Social 
Determinants of Health category. We proposed to add the Social 
Isolation data element to the OASIS.
    We solicited comment on this proposal. A discussion of the comment, 
along with our response, appears in this section of this final rule 
with comment period.
    Comment: One commenter stated that the proposed question on social 
isolation may solicit different answers based on the time horizon 
considered by the beneficiary as beneficiaries who are newly admitted 
to an HHA may have experienced differing levels of social isolation 
throughout their time in acute and post-acute care due to interactions 
with health care providers, emergency providers, and friends or family 
visiting due to hospitalization. The commenter believes this question 
could be improved by adding timeframe to the question. For example, 
``How often have you felt lonely or isolated from those around you in 
the past six months?''.
    Response: We thank the commenter for this comment and we will take 
it under advisement for future consideration. The social isolation 
question proposed is currently part of the Accountable Health 
Communities (AHC) Screening Tool. The AHC item was selected from the 
Patient-Reported Outcomes Measurement Information System 
(PROMIS[supreg]) Item Bank on Emotional Distress. At this time, we do 
not believe that we should add a time horizon to the social isolation 
question. During cognitive testing of the proposed social isolation 
question, there was no evidence of confusion related to the time 
covered.\213\ We will continue to monitor if this is an area that needs 
further clarification to satisfy the social isolation data element.
---------------------------------------------------------------------------

    \213\ National Association of Community Health Centers, 
``PRAPARE'' available at https://www.nachc.org/research-and-data/prapare/.
---------------------------------------------------------------------------

    After consideration of the public comments, we are finalizing our 
proposals to collect SDOH data for the purposes of section 2(d)(2) of 
the IMPACT Act and section 1899B(b)(1)(B)(vi) of the Act as follows. 
With regard to Race, Ethnicity, Health Literacy, Transportation, and 
Social Isolation, we are finalizing our proposals as proposed. In 
response to stakeholder comments, we are finalizing that HHAs that 
submit the Preferred Language and Interpreter Services SPADEs with 
respect to admission will be deemed to have submitted with respect to 
both admission and discharge.

J. 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, in the CY 2020 HH PPS 
proposed rule (84 FR 34684 through 34685), we proposed to amend 42 CFR 
chapter IV, subchapter G, by creating a new Sec.  484.245, titled 
``Home Health Quality Reporting Program''.
    The provisions we proposed to codify were 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) (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.

[[Page 60609]]

     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.
    Comment: One commenter supported the proposed codification of the 
HH QRP requirements.
    Response: CMS appreciates the support from the commenter for the 
codification of the HH QRP requirements.
    Comment: One commenter did not support the codification of the HH 
QRP requirements because of a concern that the current program favors 
patients whose health status will improve, and does not adequately 
consider patients whose status will just be maintained by home health 
services. The commenter believes that codification of the current 
requirements will reinforce the lack of attention given to appropriate 
delivery of maintenance nursing and therapy services.
    Response: We believe it is important to codify policies that apply 
to the HHAs as it reflects the policies that apply to HHA's relative to 
the HH QRP. We do not agree with the recommendation to not codify our 
policies.
    Final Decision: After careful consideration of the public comments 
received, we are finalizing our proposal to codify requirements for the 
HH QRP and note that we have made both a substantive change and 
technical edits.

K. Home Health Care Consumer Assessment of Healthcare Providers and 
Systems (CAHPS[supreg]) Survey (HHCAHPS)

    In the CY 2020 HH PPS proposed rule (84 FR 34685), we proposed 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 proposed to remove the pain question 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 proposed removing this particular pain 
question is consistent with the proposed removal of pain items from 
OASIS in section IV.D.1. of this final rule with comment period and is 
also consistent with the removal of pain items from the Hospital CAHPS 
Survey. The removal of the pain question 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 welcomed 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.
    We solicited comment on this proposal. A discussion of the 
comments, along with our responses, appears in this section of this 
final rule with comment period.
    Comment: We received a few comments supporting the removal of 
Question 10. Commenters supporting the proposal to remove the pain 
question either did not give a reason, or stated it would reduce 
burden. Two commenters supported the question's removal due to the 
unintended consequences of using pain killers.
    Response: We thank the commenters for their support.
    Comment: The majority of commenters opposed the removal of Question 
10. There were a number of reasons that commenters opposed the proposal 
to remove Q10 from the HHCAHPS survey and, consequently, from the 
HHCAHPS Specific Care Issues measure. Some commenters stated that pain 
assessment is a critical component of the home health care patient 
assessment protocol and should be measured as part of a patient 
experience of care survey. Several commenters contended that there is 
no evidence that the discussion of pain is linked to opioid misuse. 
Commenters wrote that home health providers are unable to prescribe 
opioids and other medications so there would be no direct impact on 
opioid prescribing. Some commenters said that because the presence of 
pain is related to the ability to function, it is important to 
determine if pain is causing a patient to have limited activity. Other 
commenters noted that talking about pain is part of the physical 
therapist's assessment of patients in home health care.
    Some commenters thought that Question 10 provides an opportunity to 
assess if home health agency staff are asking their patients about pain 
to presumably follow-up with steps to address the patients' pain and 
discomfort. An example is that a patient with diabetic complications 
may not feel pain in their feet and by the time they feel pain in a 
wound in their foot, it is likely that the wound's infection will be in 
a critical state causing significant discomfort.
    Response: We appreciate these comments and agree that monitoring 
pain is critical in the home health setting to monitor how patients are 
recovering and to identify emergent issues. Whether the question is on 
the survey or not, we expect home health agencies to continue to 
monitor pain in the home health setting.
    Final Decision: Based upon the comments received, we have evaluated 
our proposal to take into consideration points raised by commenters and 
also concerns raised within HHS. Commenters noted that monitoring of 
pain is critical and we agree that it is imperative to continue to 
monitor the management of pain. HHS reviewers also noted that removal 
of this question would potentially affect the validity of the survey 
and we also agree with their concern. Therefore, we are not finalizing 
our proposal to remove Question 10 from all HHCAHPS Surveys.

L. Form, Manner, and Timing of Data Submission Under the HH QRP

1. Background
    Section 484.250 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

[[Page 60610]]

HH QRP are not used for purposes of determining HH QRP compliance.
2. 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 final rule with comment 
period, we are finalizing our proposal 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 finalizing our proposal that HHAs 
would report the data on those measures using the OASIS. In addition, 
we are also finalizing 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. Schedule for Reporting Standardized Patient Assessment Data Elements 
Beginning With the CY 2022 HH QRP
    As discussed in section V.G. of this final rule with comment 
period, we finalized to adopt additional SPADEs beginning with the CY 
2022 HH QRP. We finalized 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 also finalized that 
HHAs that submit the Hearing, Vision, Race, Ethnicity, Preferred 
Language and Interpreter Services 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 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 consider expanding 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 was 
proposed but not finalized 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, in the CY 2020 HH PPS proposed 
rule (84 FR 34598), we sought 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?
    We did not propose to expand the reporting of OASIS data used for 
the HH QRP to include data on all HHA patients regardless of payer. We 
stated, however, that we welcomed comments on this topic, including 
comments related to the questions noted previously, and that we would 
take all recommendations received into consideration.
    Comment: Several commenters supported expanding the reporting of 
OASIS data used for the HH QRP to include data on all patients 
regardless of their payer in the future. Commenters supporting all-
payer collection cited alignment with data collection requirements for 
other PAC providers, as well as other quality programs, such as the 
Merit-based Incentive Payment System. Other reasons cited by commenters 
included more accurate representation of the quality of care furnished 
by HHAs to the entire HH population, the ability of such data to better 
guide quality improvement activities, and the reduction of current 
administrative efforts made by HHAs to ensure that only OASIS data for 
Medicare and Medicaid patients are reported to CMS. For example, one 
large HHA noted that OASIS data are already completed for approximately 
80 percent

[[Page 60611]]

of their patients. A state association commented that a survey of its 
members found that 52 percent of respondents currently use the OASIS 
assessment tool for all of their patients, regardless of payer, while 
48 percent indicated that they do not.
    Several commenters raised the need for explicit authorization to 
submit data for other payers, and noted this could create additional 
administrative burden if patient-level affirmation was required. 
Commenters asked if agencies would need to develop a waiver or consent 
for information release to be signed by patients covered by payers 
other than Medicare in order to report their OASIS data to CMS. One 
commenter recommended that CMS conduct a nationally-representative 
survey to inform this decision.
    The majority of commenters opposed expanding OASIS data reporting 
to all-payers, most frequently noting the additional administrative 
burden this would entail. A few commenters noted that the additional 
data collection was not aligned with the Patients over Paperwork 
initiative. One commenter specifically raised as an issue the burden of 
training private-duty nurses on completing the OASIS. Even when data 
are collected for all patients, some commenters noted that there would 
be additional costs of submitting those data to CMS.
    Several commenters also had concerns that the data collection could 
implicate HIPAA and questioned how CMS would plan to use these data, 
which is protected personal health information requested by a 
government entity that is not the patient's payer. One commenter 
requested that CMS provide the evidence-basis for expanding OASIS data 
collection to all payers.
    Several commenters noted there was no difference in care provided 
to patients by payer type. Commenters stated that payer mix varies 
considerably between agencies, with anywhere from 10 to 50 percent 
patients being commercially-insured. One commenter noted over fifty 
percent of their patients are Medicare patients, which they believed is 
a sufficiently representative sample for quality reporting programs.
    Several commenters described differences between commercially-
insured patients and Medicare patients, with commenters reporting that 
commercially-insured patients are usually younger and healthier, and 
recover more quickly. In addition to the differences in patient 
demographics, commenters noted that coverage of services tends to 
differ between Medicare and commercial insurance, and that some 
commercial insurance providers restrict the number of home health 
visits in ways that might alter the effectiveness of services for 
patient outcomes. They also noted that commercial insurers do not have 
a ``homebound'' requirement for patients and would not likely reimburse 
the cost of OASIS data collection. Some commenters had concerns on how 
these differences might adversely affect the quality results and 
administrative burden.
    Response: We appreciate all of the feedback that we received on 
this issue and we will take it into consideration in our future policy 
and propose it in future rulemaking whereby HHAs would be required to 
collect and submit data on HH patients regardless of their payer.

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 drugs, furnished 
by a qualified home infusion therapy supplier.
    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 same items and previously 
listed 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 with comment period (83 FR 56046), 
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 60612]]

68210).\214\ Medicare also makes a separate payment to the physician or 
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.
---------------------------------------------------------------------------

    \214\ https://www.govinfo.gov/content/pkg/FR-2012-11-15/pdf/2012-26902.pdf.
---------------------------------------------------------------------------

    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.\215\ The MACs 
review the Self-Administered Drug (SAD) exclusion lists on a regular 
basis.\216\
---------------------------------------------------------------------------

    \215\ Medicare Benefit Policy Manual, Chapter 15, ``Covered 
Medical and Other Health Services'', section 50.2--Determining Self-
Administration of Drug or Biological. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
    \216\ Self-Administered Drug (SAD) Exclusion List Report. 
www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx.
---------------------------------------------------------------------------

    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 home infusion 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.\217\ 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.
---------------------------------------------------------------------------

    \217\ Medicare National Coverage Determinations (NCD) Manual. 
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
---------------------------------------------------------------------------

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

[[Page 60613]]

a physician-established plan of care that 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 other factors such as 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) of the Act, 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 (L33794) 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.

[[Page 60614]]

    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 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 with comment period, (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),\218\ 
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 \219\ outlining the requirements for the 
claims processing changes needed to implement this payment.
---------------------------------------------------------------------------

    \218\ Local Coverage Determination (LCD): External Infusion 
Pumps (L33794). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794&ver=83&Date=05%2f15%2f2019&DocID=L33794&bc=iAAAABAAAAAA&.
    \219\ Temporary Transitional Payment for Home Infusion Therapy 
Services for CYs 2019 and 2020. August 10, 2018. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
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    And last, 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 period (83 FR 56583), we stated 
that we would carefully monitor the effects of this definition on 
access to care and that, if warranted and if within the limits of our 
statutory authority, we would engage in additional rulemaking or 
guidance regarding this definition. In that same rule, we solicited 
additional comments on this interpretation and on its effects on access 
to care.

B. CY 2020 Temporary Transitional Payment Rates for Home Infusion 
Therapy Services

    In the CY 2020 HH PPS proposed rule (84 FR 34689) we discussed 
section 1834(u)(7) of the Act 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. This temporary payment covers the cost of the 
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 found in Tables 55 and 56 in the CY

[[Page 60615]]

2019 HH PPS proposed rule (83 FR 32465 and 32466).\220\
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    \220\ CY 2019 HH PPS proposed rule (83 FR 32465 and 32466). 
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 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 for 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 payments are found in the August 10, 2018 Change 
Request 10836, ``Temporary Transitional Payment for Home Infusion 
Therapy Services for CYs 2019 and 2020.'' \221\ Therefore, as proposed, 
CMS will update the temporary transitional payment amounts based on the 
CPT code payment amounts in the CY 2020 PFS final rule. At the time of 
publication of this final rule with comment period, we do not yet have 
the CY 2020 PFS final rates; however, in accordance with the CY 2020 HH 
PPS proposed rule, the temporary transitional payments starting on 
January 1, 2020 will be based on the PFS amounts as specified in 
section 1834(u)(7)(D) of the Act. We will publish these updated rates 
in the CY 2020 PFS final rule,\222\ and will publish the updated CY 
2020 temporary transitional payment rates in the January 2020 DMEPOS 
fee schedule file.\223\ We received a few comments on the proposed rule 
regarding the CY 2020 temporary transitional payment rates for home 
infusion therapy. The following are our responses:
---------------------------------------------------------------------------

    \221\ CR 10836. Temporary Transitional Payment for Home Infusion 
Therapy Services for CYs 2019 and 2020. August 10, 2018. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
    \222\ Medicare Physician Fee Schedule. https://www.cms.gov/apps/physician-fee-schedule/.
    \223\ January 2019 DMEPOS Fee Schedules. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule-Items/DME19-A.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending.
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    Comment: A commenter stated that the lack of defined PFS rates 
presents a hardship to suppliers when creating budgets for CY 2020. 
This commenter also suggested that CMS include provisions for 
geographic adjustments to the temporary transitional payment. The 
commenter stated that geographic adjustment is necessary in light of 
nursing shortages noted in several areas of our country, and stated 
that the shortage of qualified professionals results in costs in 
recruitment, retention, and wages, and requested that CMS consider 
these challenges when reviewing the lack of geographic adjustment for 
the temporary transitional payments.
    Response: The proposed CY 2020 PFS rates for the infusion CPT codes 
can be found at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-P.html. The final rates will be 
posted in the CY 2020 PFS final rule, which we expect will be on 
display by November 1, 2019. The temporary transitional rates for home 
infusion therapy services will continue to be posted on the DMEPOS fee 
schedule file, which can be found at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule.html. The CY 2020 rates as previously discussed, 
will be posted by January 1, 2020.
    Regarding geographic adjustment, the temporary transitional payment 
is statutorily limited to the payment methodology as set forth in 
section 1834(u)(7)(D) of the Act, which states that each payment 
category is paid at amounts in accordance with the PFS for drugs 
assigned to such category without geographic adjustment.
    Comment: A commenter requested that CMS clarify that nurse 
practitioners are authorized to establish the home infusion plan of 
care during the temporary transitional period. The commenter expressed 
understanding that, as the full payment provisions for the home 
infusion benefit proposed in this year's rule do not go into effect 
until CY 2021, there is no statutory requirement that only a physician 
can establish the plan of care during the transitional payment period.
    Response: In the Home Infusion Therapy Services Temporary 
Transitional Payment Frequently Asked Questions (FAQs), we stated that 
the eligibility criteria for home infusion therapy services includes 
the patient being under a plan of care established and periodically 
reviewed by a physician prescribing the type, amount, and duration of 
infusion therapy services. The FAQs can be found at the following link: 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Downloads/Home-Infusion-Therapy-Services-Temp-Transitional-Payment-FAQs.pdf. The BBA of 2018 gives CMS the authority 
to implement requirements during the transitional payment period 
outside of rulemaking. Therefore, we are maintaining our previously-
stated requirement that only the physician can establish and review the 
plan during the transitional payment period.

C. Home Infusion Therapy Services for CY 2021 and Subsequent Years

    Upon completion of the temporary transitional payments for home 
infusion therapy services at the end of CY 2020, we will be 
implementing the permanent payment system for home infusion therapy 
services under Section 5012 of the 21st Century Cures Act (Pub. L. 114-
255) beginning January 1, 2021. In the CY 2020 HH PPS proposed rule (84 
FR 34690), we proposed provisions regarding payment for home infusion 
therapy services for CY 2021 and beyond in order 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.
    We explained that 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, and that these provisions 
serve as the basis for determining the scope of the home infusion drugs 
eligible for coverage of home infusion therapy services; outline 
beneficiary qualifications and plan of care requirements; and establish 
who can bill for payment under the benefit.
    Additionally, as previously discussed, in the CY 2019 HH PPS final 
rule with comment period (83 FR 56583), we solicited additional 
comments on our interpretation of the definition of ``infusion drug 
administration calendar day'' and on its potential effects on access to 
care. Although we did not propose a change to the definition, we 
received comments on both the CY 2019 HH PPS final rule with comment 
period and the CY 2020 HH PPS proposed rule with respect to our 
interpretation.
    Of the timely correspondence received in response to the CY 2020 HH 
PPS proposed rule, approximately 52

[[Page 60616]]

comments pertained to the home infusion therapy benefit. The following 
is a summary of the proposed rule provisions, comments received, and 
our responses.
1. Infusion Drug Administration Calendar Day
    In general, the comments received on the CY 2019 HH PPS final rule 
with comment period and the CY 2020 HH PPS proposed rule regarding 
``infusion drug administration calendar day'' were similar to those 
received on the CY 2019 HH PPS proposed rule, and focused primarily on 
the proposed definition as it pertains to the ``professional services'' 
covered under the benefit.
    Comment: Commenters continued to disagree with the final definition 
of ``infusion drug administration calendar day,'' and stated that 
payment for home infusion therapy services should include any day that 
a home infusion drug is infused, and not just a day on which a 
professional is in the home furnishing services. Specifically, 
commenters on the CY 2019 HH PPS final rule with comment period 
recommended that CMS immediately amend the definition at 42 CFR 486.505 
to eliminate the requirement that a skilled professional be in the home 
in order for reimbursement to occur. The majority of the comments 
pertaining to the home infusion benefit on the CY 2020 HH PPS proposed 
rule reiterated this recommendation and called on CMS to revise the 
existing definition of infusion drug administration calendar day to 
allow for reimbursement of home infusion services ``each day that an 
infusion drug physically enters the patient's body, irrespective of 
whether a skilled professional is in the individual's home.'' 
Conversely, MedPAC continued to support CMS' definition of infusion 
drug administration calendar day.
    Response: As we stated in the CY 2019 HH PPS final rule with 
comment period, the definition at 42 CFR 486.505 is consistent with 
section 1861(iii)(1) of the Act, which defines the term ``home infusion 
therapy'' as the items and services furnished by a qualified home 
infusion supplier, which are furnished in the individual's home. 
Additionally, 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. In 
other words, section 1834(u)(7) makes clear that while the single 
payment covers both professional services under section 1861(iii)(2)(A) 
and training and education, remote monitoring, and other monitoring 
services under section 1861(iii)(2)(B), payment is only issued on 
certain days--days on which professional services are provided in the 
patient's home.
    Comment: Commenters stated that by not defining ``professional 
services'' and limiting payment to a day on which a skilled 
professional is in the home, CMS fails to capture a broader cross-
section of professional services that do not occur in the patient's 
home, but that are critical to ensure the safe and effective provision 
of home infusion therapy services. Several commenters specified that 
these services include compounding and dispensing of the drug; however, 
some commenters also identified ``remote pharmacy services'' that they 
believe should be included in the payment. Commenters on the CY 2020 HH 
PPS proposed rule elaborated on the notion of ``remote pharmacy 
services,'' stating that these services include initial and ongoing 
pharmacist assessments; clinical care planning; drug preparation and 
compounding; care coordination; medication reconciliation; monitoring, 
(including remote monitoring) for adverse events and response to 
therapy; drug therapy evaluation and design; pharmacist interventions 
and subsequent therapeutic recommendations to prescribers; patient 
education; and all other associated professional work.
    Response: The drugs identified for coverage of home infusion 
therapy services are paid under the Part B DME benefit. Therefore, the 
services related to the furnishing of the drug, remote or otherwise, 
are paid under the DME benefit. Furthermore, a ``qualified home 
infusion therapy supplier'' as defined in section 1861(iii)(3)(D)(i) of 
the Act, is not required to furnish services related to the furnishing 
of the drug. In the CY 2019 HH PPS final rule with comment period CMS 
stated that we acknowledge that pharmacy services are closely related 
to the home infusion therapy benefit; however, at this time pharmacy 
services, furnished by a Medicare-enrolled DMEPOS supplier, associated 
with the preparation and dispensing of home infusion drugs are covered 
under the Part B DME benefit and are not part of the specific home 
infusion therapy benefit (83 FR 56563).
    In the CY 2019 HH PPS proposed rule (83 FR 32467) we stated that 
the DME supplier standards require the DME supplier to document that it 
or another qualified party has at an appropriate time provided 
beneficiaries with the necessary information and instructions on how to 
use Medicare-covered items safely and effectively.\224\ Therefore, the 
professional services covered under the home infusion benefit would 
include a limited amount of training and education on the provision of 
home infusion drugs that is not already covered under the DME benefit 
regarding the appropriate and safe use of the equipment.
---------------------------------------------------------------------------

    \224\ https://www.cms.gov/Medicare/wwwProvider-Enrollment-and-Certification/MedicareProviderSupEnroll/wwwdownloads/DMEPOSSupplierStandards.pdf.
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    In accordance with section 1861(iii)(1)(B), an individual must be 
under a plan of care established by a physician, prescribing the type, 
amount, and duration of infusion therapy services, in coordination with 
the furnishing of home infusion drugs. In order to avoid being overly 
prescriptive, we did not define ``professional services'' or enumerate 
a list of services that are covered under the benefit. We did not want 
to inadvertently omit services which may be necessary for an individual 
patient or particular therapy or course of treatment, as determined by 
the physician responsible for the plan of care. As previously discussed 
and in the CY 2019 proposed rule, the services provided under the home 
infusion therapy benefit are distinct from those required and paid 
under the DME benefit (that is, instruction on how to safely and 
effectively use the DME equipment) and :

 Training and education on care and maintenance of vascular 
access devices:
++ Hygiene education
++ Instruction on what to do in the event of a dislodgement or 
occlusion
++ Education on signs and symptoms of infection
++ Teaching and training on flushing and locking the catheter
++ Dressing changes and site care
 Patient assessment and evaluation:
++ Review of patient's history and assessment of current physical and 
mental status, including obtaining vital signs
++ Assessment of any adverse effects or infusion complications
++ Evaluation of family and caregiver support
++ Review of prescribed treatment and any concurrent oral and/or over-
the-counter Treatments
++ Obtaining blood for lab-work
 Medication and disease management education:
++ Instruction on self-monitoring
++ Education on lifestyle and nutritional modifications

[[Page 60617]]

++ Education regarding drug mechanism of action, side effects, 
interactions with other medications, adverse and infusion-related 
reactions
++ Education regarding therapy goals and progress
++ Instruction on administering pre-medications and inspection of 
medication prior to use
++ Education regarding household and contact precautions and/or spills
 Remote monitoring services
 Monitoring services:
++ Communicating with patient regarding changes in condition and 
treatment plan
++ Monitoring patient response to therapy
++ Assessing compliance

    Comment: A few commenters stated that Medicare's interpretation of 
``infusion drug administration calendar day'' under the home infusion 
therapy benefit is inadequate to cover the cost of care, and that 
consequently, home infusion suppliers would be forced to discontinue 
home infusion therapy services to Medicare beneficiaries. Some 
commenters specifically identified subcutaneous immunoglobulin, stating 
that administration of this biological requires virtually no 
professional services in the home, and therefore the home infusion 
supplier would never be reimbursed for the ``pharmacy-based'' services 
furnished outside of the home. Commenters stated that this would impede 
access to these services and force patients to receive their infusions 
in the physician's office, outpatient department, hospital, or nursing 
home, which are more costly and clinically less appropriate.
    Response: The single payment for the home infusion therapy services 
is only made when a skilled professional is in the patient's home on a 
day of drug administration. This single payment does not include the 
DME external infusion pump, supplies (including the home infusion 
drug), and related services paid under the DME benefit. Medicare 
payment for an infusion drug administration calendar day is separate 
from the payment for DME items and services, therefore, a supplier 
could still be paid for DME items and services under the DME benefit, 
even if it does not receive payment for home infusion therapy services. 
Additionally, the home infusion therapy services payment is a single 
bundled payment amount, set equal to the administration services 
furnished in a physician's office for each infusion drug administration 
calendar day, regardless of the actual length of the visit. Therefore, 
it is unclear why suppliers would limit access to patients requiring 
``virtually no services in the home,'' when suppliers are still being 
paid for the DME, supplies (including the home infusion drug), and 
services covered under the DME benefit, as well as an additional 
payment for professional services equal to a set amount of hours, 
regardless of the actual visit length, when a home visit is furnished.
    Comment: A commenter noted anecdotally that since the 
implementation of the transitional benefit DME suppliers have begun to 
consolidate or no longer accept new patients under the Part B benefit, 
and anticipate that more beneficiaries will face access barriers. 
Commenters requested that CMS make utilization data from 2019 available 
for public review to allow for a full assessment of how the current 
policy has impacted access and/or contributed to provider 
consolidation.
    Response: As we stated in the CY 2019 HH PPS final rule with 
comment period, CMS will monitor home infusion therapy utilization to 
determine what, if any, effects on access to care occur after 
implementation of the temporary transitional payments for home infusion 
therapy. Since the implementation of these payments on January 1, 2019 
we have been collecting quarterly data on the number of home infusion 
therapy users; volume of infusion therapy prescription fills, including 
by category and individual drugs; and number of DME suppliers 
furnishing home infusion therapy. We have been monitoring changes in 
trends between quarters, nationwide trends, and trends across the 
payment categories and among individual drugs, beneficiary 
characteristics, and by geographic variation. We have also been 
monitoring trend data from the past before the implementation of the 
temporary transitional home infusion therapy payments. Based on the 
claims data from Q1 2016 to Q4 2018, we found that overall, the 
utilization of infusion services in Q4 2018 shows a steadily increasing 
trend across all three care settings (home, outpatient, and physician's 
office). Specifically, both the numbers of prescription fills and 
claims for the transitional infusion drugs in the home setting 
increased steadily in Q4 2018, compared to the previous quarter. 
Additionally, although there has been fluctuation in the number of DME 
suppliers supplying transitional home infusion drugs, from Q1 2016 
through Q3 2018, the number has increased between Q3 and Q4, indicating 
that access to services has not been negatively impacted since the drug 
pricing change from average wholesale price (AWP) to average sales 
price (ASP) plus 6 percent took effect on January 1, 2017. We will 
continue to monitor and analyze claims data in order to determine 
whether, and how access to home infusion therapy services has been 
impacted since the implementation of the home infusion benefit in CY 
2019. We are currently still receiving and analyzing claims data during 
this time period; however, we note that home infusion utilization for 
Q1 2019 has been stable and shown slight increases since Q1 2017. We 
also note that this monitoring and analysis is unrelated to CMS's legal 
interpretation of the term ``infusion drug administration calendar 
day.'' We anticipate releasing our analysis of claims data from Q1 2016 
through CY 2019 once we have more complete data for CY 2019.
2. Home Infusion Drugs
    In the CYs 2019 and 2020 Home Health Prospective Payment System (HH 
PPS) proposed rules (83 FR 32466 and 84 FR 34690) 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 external infusion pump, supplies 
(including the home infusion drug), and services covered under the DME 
benefit. We stated that, 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 (L33794),\225\ when such services 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 this LCD for External Infusion 
Pumps. We also noted that although 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

[[Page 60618]]

therapy services will be covered beginning in CY 2021.
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    \225\ Local Coverage Determination (LCD): External Infusion 
Pumps (L33794). https://med.noridianmedicare.com/wwwdocuments/2230703/7218263/External+wwwInfusion+Pumps+LCD+and+PA.
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    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. As noted in the 
proposed rule, 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. 
Therefore, we stated that this means that ``home infusion drugs'' are 
defined as 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, pursuant to the 
statutory definition set out at section 1861(iii)(3)(C) of the Act, and 
incorporated by cross reference at section 1834(u)(7)(A)(iii) of the 
Act.
    Comment: A commenter requested clarification regarding the 
applicability of payment for services under the home infusion benefit 
specifically with regard to the administration of intravenous 
immunoglobulin (IVIG). The commenter noted that we stated in the 
proposed rule that payment category 1 would include any subsequent 
intravenous infusion drug additions, and stated that a plain reading of 
the statutory language indicates that IVIG products would meet the 
definition of a home infusion drug administered intravenously and thus, 
would be covered under the home infusion therapy payment beginning in 
CY 2021. This commenter stated that the proposed codes for home 
infusion therapy services payment categories, however, do not reflect 
how IVIG services will be addressed. Similarly, another commenter 
recommended including IV antibacterial drugs to the list of home 
infusion drugs eligible for services beginning in CY 2021.
    Response: As discussed in the CY 2020 HH PPS proposed rule (84 FR 
34690), we stated that Medicare payment for home infusion therapy 
services is for services furnished in coordination with the furnishing 
of the intravenous and subcutaneous infusion drugs and biologicals 
specified on the DME LCD for External Infusion Pumps (L33794), with the 
exception of insulin pump systems and drugs and biologicals on a self-
administered drug exclusion list. In order for the drugs and 
biologicals to be covered under the Part B DME benefit they must 
require infusion through an external infusion pump. If the drug or 
biological can be infused through a disposable pump or by a gravity 
drip, it does not meet this criterion. IVIG does not require an 
external infusion pump for administration purposes and therefore, would 
not be covered under the DME LCD for External Infusion Pumps. We note 
that a DME external infusion pump is also not covered under the 
Medicare Intravenous Immune Globulin Demonstration. The Frequently 
Asked Questions (FAQs) regarding this demonstration state that it is up 
the supplier to determine the services and supplies appropriate and 
necessary to administer the IVIG in any given situation, and that this 
may or may not include the use of a pump.\226\ Furthermore, the LCD 
specifically states that intravenous immune globulin products are not 
covered under this LCD and specifies that DME coverage of subcutaneous 
immune globulin (SCIG) applies only to those products that are 
specifically labeled as subcutaneous administration products. This 
means that immune globulin labeled for both intravenous and 
subcutaneous use would not be covered under the LCD.
---------------------------------------------------------------------------

    \226\ https://innovation.cms.gov/wwwinitiatives/IVIG/supplierfaq.html.
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    The reference to payment category 1 including any subsequent 
intravenous drug or biological additions is in reference to the DME LCD 
for External Infusion Pumps (L33794). In the CY 2020 HH PPS proposed 
rule (84 FR 34687) we stated that the DME Medicare Administrative 
Contractors (MACs) specify the details of which infusion drugs are 
covered with these pumps through local coverage policies. We also gave 
examples of covered Part B DME infusion drugs, which we stated 
currently include, among others, certain IV drugs for heart failure and 
pulmonary arterial hypertension; immune globulin for primary immune 
deficiency (PID); insulin; antifungals and antivirals; and 
chemotherapy, in limited circumstances. As previously discussed, the 
immune globulin for PID currently covered under the DME LCD for 
External Infusion Pumps (L33794) is only immune globulin which is 
administered subcutaneously, not intravenously, and is paid under 
payment category 2 of the temporary transitional home infusion therapy 
services payment. If the MACs determine that additional intravenous 
infusion drugs or biologicals (excluding chemotherapy drugs or other 
highly complex drugs and biologicals, as those would be paid under 
payment category 3) meet the criteria to be added to the DME LCD for 
External Infusion Pumps (L33794), then home infusion therapy services 
for these newly added intravenous drugs would be covered under payment 
category 1. Likewise, although there are a few antifungal and antiviral 
drugs covered under the DME LCD for External Infusion Pumps (L33794), 
there are currently no antibacterial drugs included and therefore, 
services for these drugs would not be covered under the home infusion 
therapy benefit at this time. In general, antibiotics do not require 
the use of a DME external infusion pump and can be given through an 
elastomeric pump or by gravity infusion.
    Comment: Commenters requested coverage of home infusion therapy 
services for other drugs and biologicals currently covered under the 
DME LCD for External Infusion Pumps (L33794). A commenter recommended 
we cover services for Carbidopa 5 Mg/Levodopa 20 Mg enteral suspension 
and Hizentra, a subcutaneous immunoglobulin. The commenter noted that 
the pump and supplies for Carbidopa/Levodopa are billed to DME, similar 
to immune globulin, and recommended services be covered under payment 
category 2. Regarding Hizentra, the commenter urged CMS to either 
extend coverage for services under the home infusion benefit in CY 2021 
or remove Hizentra from the self-administered drug exclusion list. Also 
with regard to the self-administered drug exclusion lists, another 
commenter encouraged CMS to consider giving additional guidance to the 
MACs regarding the process and time involved in administering SCIG 
therapies. Lastly, a commenter recommended identifying all such drugs 
administered via external infusion pumps covered under the DME benefit 
as ``home infusion drugs.''
    Response: As noted previously, section 1861(iii)(3)(C) of the Act 
defines a ``home infusion drug'' as a parenteral drug or biological 
administered intravenously or subcutaneously. Although we clarified 
that a ``home infusion drug'' is a drug or biological included on the 
DME LCD for External Infusion Pumps (L33794), there are drugs and 
biologicals on this LCD that do not meet the definition of ``home 
infusion drug'' required by statute. While Carbidopa/Levodopa is on the 
DME LCD, because it is an enteral infusion and not administered 
intravenously or subcutaneously, it does not meet the statutory 
definition of

[[Page 60619]]

home infusion drug. Additionally, in the CY 2020 HH PPS proposed rule, 
we identified additional drugs covered under the temporary transitional 
payment that would be excluded from the permanent benefit because they, 
similarly, do not meet the statutory definition of home infusion drug. 
We stated that Ziconotide and Floxuridine are not considered ``home 
infusion drugs'' because they are not administered either 
subcutaneously or intravenously (84 FR 34695). Section 1861(iii)(3)(C) 
of the Act also excludes insulin pump systems and any drugs or 
biologicals on self-administered drug exclusion lists from the 
definition of home infusion drug. Therefore, this provision excludes 
Hizentra, which is on a self-administered drug exclusion list, from the 
benefit beginning in CY 2021. Because this is a statutory exclusion, 
CMS does not have the authority to extend coverage under the home 
infusion benefit for services related to drugs and biologicals on these 
lists. In the CY 2020 HH PPS proposed rule we discuss that the 
determination for which drugs and biologicals belong on a self-
administered drug exclusion list is made on a drug by drug basis, 
taking into account whether a drug is self-administered by more than 50 
percent of Medicare beneficiaries (84 FR 34687). Chapter 15, section 
50.2 of the Medicare Benefit Policy Manual \227\ addresses the specific 
policy for making this determination in general, therefore, further 
guidance to the MACs regarding specific therapies is unnecessary.
---------------------------------------------------------------------------

    \227\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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    Comment: Many commenters expressed concern that relying on the DME 
LCD for External Infusion Pumps limits the ability for new and/or 
innovative drugs to be added under the home infusion therapy benefit. 
Commenters indicated that the LCD process and the DME criteria is such 
that the DME MACs continue to evaluate drugs based on the notion that 
only drugs that patients can self-administer, or that a caregiver can 
administer for the patient, can be added. Commenters recommended that 
CMS require the DME MACs to increase transparency of their coverage 
policy by further detailing the criteria used to make coverage 
determinations and ensuring that coverage determinations follow current 
clinical practice guidelines and patient need. Another commenter urged 
CMS to clarify that Medicare covers the cost of pump maintenance for 
the duration of the drug's use in treating the beneficiary and further 
clarify that pumps supplied per the benefit remain the property of the 
pharmacy and are returnable when the beneficiary ceases service.
    Response: As detailed in section VI.C.1.a. of the CY 2020 HH PPS 
proposed rule, home infusion drugs are those drugs and biologicals 
identified on the DME LCD for External Infusion Pumps (L33794). This 
does not however, limit the scope of drugs to only those drugs and 
biologicals which are currently on this LCD at this time. Table 30 
lists the drugs and biologicals which are currently on the DME LCD for 
External Infusion Pumps (L33794), and which also meet the definition of 
a home infusion drug; however, it is important to note that this list 
is not static. The DME criteria used to determine which items are 
included on the LCD for External Infusion Pumps, as well as the cost of 
pump maintenance, is out of the scope of this final rule with comment 
period, which focuses on the home infusion therapy benefit. However, in 
response to stakeholder concerns regarding the limitations of the DME 
LCDs for External Infusion Pumps that preclude coverage to certain 
infused drugs, we are soliciting comments on the criteria CMS could 
consider to allow coverage of additional drugs under the DME benefit.
    With regard to transparency in the LCD Development Process, the 
21st Century Cures Act required a summary of the evidence and a 
publication of a written explanation of the rationale to be included in 
the LCD. The new LCD development process that includes these procedures 
is outlined in Chapter 13 of the Medicare Program Integrity Manual 
(PIM); pub. 100-08 (found at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html) and went 
into effect on January 1, 2019. Therefore, the new LCD development 
requirements do not apply to local coverage policies prior to the 
effective date of January 1, 2019.
    In addition, the mechanism that allows the Medicare Administrative 
Contractors (MACs) to change coverage continues to be the LCD 
reconsideration process. The LCD reconsideration process allows any 
stakeholder to submit new evidence to ask for a reconsideration of the 
policy. The full LCD reconsideration process and requirements are also 
located at Chapter 13 of the PIM. We encourage stakeholders with 
additional evidence to engage their MAC in consultation regarding the 
available evidence that was not considered in the initial review, or to 
sensitize the MAC of emerging evidence that could be useful in an 
upcoming reconsideration once published.
3. 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, we proposed to make a number 
of revisions to the regulations to implement the home infusion therapy 
services payment system beginning on January 1, 2021. We proposed 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 proposed 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 proposed at Sec.  414.1510 that, as a 
condition for payment, qualified home infusion therapy suppliers must 
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 proposed 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 proposed 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 proposed to require at Sec.  
414.1515, that

[[Page 60620]]

the plan of care must contain those items listed in Sec.  486.520(b). 
We also stated that 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. The following is a summary of the 
comments received on the proposed conditions for payment, which include 
patient eligibility and plan of care requirements, and our responses.
    Comment: A commenter stated that proposed Sec.  414.1515(c) does 
not provide applicable providers the authority to properly manage home 
infusion patients under their care. The commenter noted that while the 
statute says that a physician is required to establish and periodically 
review the plan of care, the patient can be under the care of an 
applicable provider, which does not have to be a physician. Commenters 
disagreed with the portion of proposed Sec.  414.1515(c) which states 
that a physician must sign and date the plan of care upon any changes 
to the plan of care, and stated that this is not required by statute 
and prevents an applicable provider from managing a patient under his/
her care when the applicable provider is not the ordering physician. 
This commenter requested that CMS remove this language from proposed 
Sec.  414.1515 or amend the language to state that the ``ordering 
physician or applicable provider must sign and date the plan of care 
upon any changes to the plan of care.''
    Response: We appreciate the commenter's review of the regulatory 
language and recognition that in accordance with section 
1861(iii)(1)(A) of the Act, the patient must be under the care of an 
applicable provider, which as defined in 1861(iii)(3)(A) of the Act, is 
a physician, nurse practitioner, or physician assistant. Additionally, 
section 1861(iii)(1)(B) of the Act, states that the beneficiary must be 
under a plan of care, established by a physician (defined at section 
1861(r)(1) of the Act). Therefore, for payment purposes, the plan of 
care must be established and reviewed by a physician. This means that 
all services billed to Medicare have to be reflected in the plan of 
care, which is required to be established and reviewed by the 
physician, which includes any changes or updates to the plan, as stated 
in the regulatory language. We will consider whether an applicable 
provider can update the plan of care for future rulemaking.
    Comment: Several commenters recommended that CMS adopt a timeframe 
for the physician review of the plan of care. Some commenters 
specifically recommended that CMS require the physician to review the 
plan of care at least every 90 days.
    Response: As section 1861(iii)(1)(B) of the Act states that the 
plan of care must be periodically reviewed by a physician in 
coordination with the furnishing of home infusion drugs, we believe 
this to mean that the home infusion plan of care must be established 
and reviewed by the physician, in consultation with the DME supplier 
responsible for furnishing the home infusion drugs. Additionally, the 
DME Quality Standards require suppliers to work collaboratively with 
the physician prescribing the drug, who is ultimately responsible for 
any changes in type, dosage, and frequency of medication. Therefore, as 
coordination is required between the entity responsible for furnishing 
the drug, and both the entities (if they are not the same entity) 
responsible for ordering the home infusion therapy services and the 
home infusion drug, we would expect all entities to be involved in the 
care coordination process.
    However, we do recognize the integral part the plan of care plays 
in care coordination between providers, particularly when the physician 
ordering the home infusion drug is not the same physician establishing 
the home infusion therapy plan of care. Coordination between the 
physician ordering the home infusion drug, the physician ordering the 
home infusion services, and the DME supplier furnishing the home 
infusion drug is imperative in providing safe and effective home 
infusion therapy. Coordination would likely include review of the 
patient assessment and evaluation, including interpretation of lab 
results as they pertain to changes in medication type, dose, or 
frequency. And, as many of the home infusion drugs and biologicals 
likely require weekly bloodwork and close monitoring, a current home 
infusion therapy plan of care is essential in order to ensure that the 
qualified home infusion therapy supplier is providing the appropriate 
professional services, including patient monitoring, to ensure that 
administration is safe and effective. Additionally, these drugs and 
biologicals treat a variety of both acute and chronic conditions. 
Treatment regimens and schedules will likely vary in length and 
intensity depending on the drug, individual response to therapy, and 
disease progression. As such, patient needs, including interventions 
and monitoring, will likely fluctuate based on short-term and long-term 
goals of the varying treatment regimens. For this reason, in order to 
ensure that therapy is safe and effective throughout the course of 
treatment, the physician responsible for the home infusion therapy plan 
of care should review the plan on a regular basis, in coordination with 
the DME supplier.
    We received comments on the proposed health and safety standards in 
the CY 2019 HH PPS proposed rule stating that establishing timeframe 
requirements could conflict with State laws, creating duplicative 
requirements, which may add burden to home infusion therapy suppliers. 
Therefore, we stated in the CY 2019 HH PPS final rule with comment 
period that we would not include specific timeframes for the review of 
the plan of care, and will defer to existing State laws and regulations 
(83 FR 56563). However, we will take the recommendations received on 
the CY 2020 HH PPS proposed rule regarding establishing a timeframe for 
physician review under consideration for future rulemaking.
    Comment: Several commenters recommended that CMS require that home 
infusion suppliers document the following in the plan of care: Drug 
name, strength, and dosage; frequency of administration; route of 
administration; method of administration; and a care plan for the 
following professional services: Patient assessments; drug therapy 
evaluation and design; drug preparation and compounding; care 
coordination; monitoring and remote monitoring; and nursing services.
    Response: The CY 2019 HH PPS final rule with comment period 
finalized the plan of care requirements for home infusion therapy 
suppliers. Section 486.520(b) requires that the home infusion therapy 
supplier 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 
would also include the specific medication, including 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 
care and services necessary to meet the patient-specific needs (83 FR 
56562). Additionally, proposed Sec.  414.1515 requires, as a condition 
for payment, that in addition to the elements indicated in Sec.  
486.520(b), 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. These required elements

[[Page 60621]]

capture the majority of the commenters' recommendations; however, any 
additional regulatory plan of care elements would be required to go 
through notice and comment rulemaking.
    Comment: Several commenters recommended that CMS add a requirement 
that the same physician be responsible for signing the DME detailed 
written order (DWO) and the home infusion therapy plan of care. 
Commenters stated that because CMS is proposing to allow the DME 
supplier and the home infusion therapy supplier to be different 
entities, there is a risk for medication errors resulting from 
conflicting orders being obtained by the individual providers involved 
in the patient's care.
    Response: We recognize the commenter's concern; however, the 
statute does not specify that the home infusion plan of care must be 
established by the same physician who orders the DME and signs the DWO. 
While we would expect that in most cases the physician ordering the 
home infusion therapy services is the same physician ordering the DME 
and the infusion drug, we recognize that this may not always be the 
case. However, Sec.  486.520(a) requires that in addition to the 
professional services utilized for treatment, the home infusion plan of 
care must include the specific home infusion drug or biological, along 
with the prescribed dosage and frequency of the medication. Therefore, 
regardless of whether the physician ordering the home infusion drug is 
the same physician ordering the home infusion therapy services, there 
must be care coordination between both entities in order to meet the 
plan of care requirements under Sec.  486.520(a).
    Comment: A commenter noted that in the CY 2019 HH PPS final rule 
with comment period, CMS finalized the definition of ``applicable 
provider'' at Sec.  486.505 as ``a physician, a nurse practitioner, and 
a physician assistant;'' however, the regulatory language under 42 CFR 
486.505 uses the term ``nurse provider'' rather than ``nurse 
practitioner.'' The commenter therefore, requested a technical edit of 
42 CFR 486.505 to change the language to read ``nurse practitioner'' in 
accordance with the statutory definition at 1861(iii)(3)(A) of the Act.
    Response: We thank the commenter for his/her review of the 
regulatory language and agree that the language at Sec.  486.505 should 
be changed from ``nurse provider'' to ``nurse practitioner'' and will 
be modified accordingly.
    Final Decision: We are finalizing, as proposed, the home infusion 
therapy services conditions for payment at 42 CFR part 414, subpart P.
    In addition, in response to the comment made regarding terminology, 
we will amend the regulations at Sec.  486.505 to change the term 
``nurse provider'' to ``nurse practitioner.'' We are also amending 
Sec.  414.1550(a)(1) and (2) to include ``or service.'' Although these 
changes were not proposed in the proposed rule, we are adopting the 
changes here under a ``good cause'' waiver of proposed rulemaking. The 
specific changes we are making in the regulations are simply technical 
corrections in the language and do not reflect any additional 
substantive changes. Therefore, we find that undertaking further notice 
and comment procedures to incorporate these corrections into this final 
rule with comment period is unnecessary and contrary to the public 
interest.
4. 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. Importantly, neither the statute, nor 
the health and safety standards and accreditation requirements, 
outlined in 42 CFR part 486, require the qualified home infusion 
therapy supplier to furnish the pump, home infusion drug, or related 
pharmacy services. Therefore, in the CY 2020 HH PPS proposed rule, we 
noted that the infusion pump, drug, and other supplies, and the 
services required to furnish these items (that is, the compounding and 
dispensing of the drug) remain covered under the DME benefit.
    We stated in the CY 2020 HH PPS proposed rule that we did not 
specifically enumerate a list of ``professional services'' for which 
the qualified home infusion therapy supplier is responsible 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 
(84 FR 34692). However, we noted 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 statute. We stated that this 
means that 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, payment for these 
services is built into the bundled payment for an infusion drug 
administration calendar day.
    Comment: A commenter supported CMS' efforts to promote supplier 
participation in Medicare home infusion therapy services and improve 
access for beneficiaries by giving them more choices of providers under 
the benefit.
    Response: We thank the commenter for this recognition and also 
anticipate that the breadth of providers able to become accredited as 
qualified home infusion therapy suppliers will help ensure continued 
access to home infusion services.
    Comment: A commenter referenced the discussion of billing for 
chronic care management and remote patient monitoring codes associated 
with the home infusion benefit. The commenter indicated that CMS only 
references ordering physicians and does not mention applicable 
providers, and stated that CMS should clarify that these codes, and 
other care coordination services, are billable by the applicable 
provider managing the patient's care. Another commenter suggested 
adding teaching and training users to self-administer using a pump, 
troubleshooting pump issues (for example, telephonically or via video 
monitoring); and providing clinical/quality assessments such as 
monitoring the efficacy of drugs (for example, number of infections for 
a user of immune globulin diagnosed with primary immunodeficiency 
(PID)) to the proposed list of remote monitoring services.
    Response: The discussion referencing the PFS chronic care 
management and remote monitoring codes was regarding the services for 
which a provider can bill separately under the PFS and was referenced 
in order to separate these services from the care coordination included 
in the bundled services under the single unit of payment for home

[[Page 60622]]

infusion therapy suppliers. These are not codes for which home infusion 
therapy suppliers can bill separately under the home infusion therapy 
benefit, therefore, which providers can bill for these codes is out of 
the scope of the CY 2020 HH PPS final rule with comment period.
    Additionally, as we did not propose a list of remote monitoring 
services considered professional services under the home infusion 
therapy benefit, it is unclear if the comment regarding teaching and 
training on the pump pertains specifically to the CY 2020 HH PPS 
proposed rule. However, we will note that the commenter's suggestion 
that the infusion therapy supplier engage in training and education on 
the item of DME, address services already covered under the DME 
benefit, and would not be covered under the home infusion therapy 
benefit. Additionally, in the CY 2019 HH PPS proposed rule, although we 
did not define home infusion therapy professional services, we did give 
examples of services we believe fall under the home infusion therapy 
benefit. Clinical assessments, including monitoring efficacy of drug 
therapy, was included in these examples (83 FR 32468).
    Comment: Several commenters expressed concern about care 
coordination between different entities providing services under 
various benefits. These commenters stated that the proposed rule tasked 
the home infusion therapy supplier with furnishing the necessary 
services to administer the drug in the home, but does not require the 
qualified home infusion therapy supplier to furnish the pump, home 
infusion drug, or related pharmacy services. Commenters stated that 
because ``CMS' interpretation'' allows the DME supplier and the home 
infusion therapy supplier to be separate entities, this could 
potentially create confusion about roles and responsibilities. Further, 
commenters indicated that CMS makes no requirement for the provider of 
HIT services to coordinate directly with the DME supplier. A commenter 
stated that typically, commercial payers structure the home infusion 
benefit as a pharmacy-coordinated service, where the pharmacy assumes 
responsibility for case managing the therapy and provides oversight of 
all the professional services. The commenter noted that under the 
commercial payer structure, the pharmacy is the entity contracted to 
supply the drugs, equipment, and supplies, and because of the 
dependency between these two components of care, commercial payers and 
accreditation organizations never separate the case management from the 
supplier of the drug, equipment, and supplies. Commenters recommended 
that the Secretary add a new requirement that the home infusion therapy 
supplier be enrolled in the DME program as a pharmacy that provides 
external infusion pumps and supplies, and that maintains all pharmacy 
licensure and accreditation requirements, and that all components of 
the home infusion benefit should be billed by the same provider, 
including professional services, drugs, pumps, and supplies.
    Response: We recognize that there may be various providers and 
suppliers involved in a patient's care in the provision of home 
infusion therapy and the importance of care coordination. While the 
supplier furnishing the DME, home infusion drug, and related services 
may be the supplier furnishing the home infusion services, the statute 
does not require that the DME supplier also furnish home infusion 
therapy 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. There is no provision requiring the home 
infusion therapy supplier to furnish the infusion pump, drug, or other 
supplies. Further, section 1861(iii)(3)(D)(ii) of the Act allows a 
qualified home infusion therapy supplier to sub-contract with a 
pharmacy, physician, provider of services, or supplier to provide these 
services. Additionally, section 1861(u) of the Act defines ``provider 
of services'' to mean a hospital, critical access hospital, skilled 
nursing facility, comprehensive outpatient rehabilitation facility, 
home health agency, hospice program, or, for purposes of sections 
1814(g) and 1835(e) of the Act, a fund. Therefore, any of the 
previously noted entities who meet the Medicare accreditation 
requirements for home infusion therapy suppliers is eligible to enroll 
as a qualified home infusion therapy supplier.
    We also do not anticipate a lapse in care coordination in the case 
that the home infusion therapy supplier is not the same entity 
furnishing the DME, drug, and related services. Section 1861(iii)(1)(B) 
of the Act states that the home infusion therapy plan of care must be 
established and periodically reviewed by a physician in coordination 
with the furnishing of home infusion drugs. As previously stated, this 
means that the home infusion plan of care must be established and 
reviewed by a physician in consultation with the DME supplier 
responsible for furnishing the home infusion drug and related services. 
Likewise, as discussed in the CY 2020 HH PPS proposed rule, the DME 
Quality Standards require the supplier (furnishing the infusion drug) 
to consult with the physician prescribing the infusion drug as needed 
to confirm the order and to recommend any necessary changes, 
refinements, or additional evaluation to the prescribed equipment 
item(s), and/or service(s) (84 FR 34692). Therefore, as the DME 
supplier is required to consult with the physician prescribing the 
infusion drug, initially and upon any changes in medication or orders, 
and the physician responsible for drafting the home infusion plan of 
care is required to consult with the DME supplier and the home infusion 
therapy supplier, we would expect the home infusion therapy plan of 
care to be current. Furthermore, proposed Sec.  414.1515 requires that 
the home infusion plan of care contain the items indicated in Sec.  
486.520(b), which includes the specific medication, the prescribed 
dosage and frequency, as well as the professional services to be 
utilized for treatment, including the care and services necessary to 
meet patient-specific needs. Additionally, proposed Sec.  414.1515 
requires the plan of care to include the healthcare professional that 
will furnish each of the ordered services. Therefore, while the home 
infusion therapy supplier may not be the DME supplier, the home 
infusion plan of care must contain the required contents, as previously 
discussed, and established in coordination with the furnishing of the 
infusion drug. For this reason, in order to ensure that therapy is safe 
and effective throughout the course of treatment, as required by 
section 1861(iii)(1)(B) of the Act, the physician who orders the home 
infusion therapy services must review the plan of care on a regular 
basis, in coordination with the DME supplier, who is also required to 
consult with the physician prescribing the infusion drug.
    Comment: A commenter requested that CMS clarify whether there will 
be a grace period for accreditation, and whether or not more 
accrediting bodies be added.
    Response: Home Infusion Therapy (HIT) Accreditation Organizations 
will be held to the same expectations as our remaining accreditation 
organizations. The home infusion therapy application procedures and 
ongoing responsibilities are provided at 42 CFR part 488, subpart L. 
Any accreditation organization will be allowed to apply to be a CMS 
Approved Deeming Accreditation Organization for Home Infusion

[[Page 60623]]

Therapy, if the organization meets all of the requirements provided at 
42 CFR 488.1010. Applications will be considered for the January 1, 
2021 designation deadline, if the application is received by April 1, 
2020.
    Comment: Several commenters indicated that reimbursement under the 
DME benefit is inadequate to cover the home infusion therapy 
professional services and stated that Congress understood that the 
breadth and frequency of these services exceeds the scope of the DME 
benefit. Other commenters stated that the home infusion therapy payment 
was intended to make up for the drug pricing change from AWP to ASP 
plus 6 percent. Commenters stated that it is for these reasons that 
Congress created the home infusion therapy benefit and intended for 
these services, most notably those provided remotely by a pharmacist, 
to be reimbursed without regard to overlap with the DME benefit or 
contingent on the patient's nursing needs. Additionally, commenters 
stated that it is notable that Congress exempted training and education 
that is not otherwise paid for as DME from the professional services 
reimbursement, but made no such exemption for professional services, 
remote monitoring and monitoring services, or the other professional 
services referenced in the proposed rule.
    Response: We are unsure of whether Congressional intent for the 
home infusion benefit was to reimburse providers for the change in drug 
pricing. However, in general, Medicare does not implement new benefits 
in order to subsidize other existing benefits. Additionally, because 
the home infusion therapy services payment does not include payment for 
the DME or the home infusion drug, the adequacy of the drug pricing is 
out of the scope for this final rule with comment period. Although the 
commenter stated that the home infusion therapy payment is for services 
``without regard to overlap with DME,'' it is important to note that 
Medicare does not make duplicative payment for services, therefore we 
would not require two benefits to furnish the same services.
    Additionally, CMS did not define or enumerate the professional 
services under the home infusion therapy benefit in order to avoid 
inadvertently excluding certain services. However, we agree that it is 
notable that training and education not otherwise paid for as DME is 
exempted from the professional services covered under the home infusion 
therapy benefit. The training and education provided under the DME 
benefit are services that would likely be furnished in the patient's 
home. Therefore, in order to avoid making duplicative payment, the 
training and education furnished under the DME benefit is explicitly 
excluded from the home infusion therapy services payment. Furthermore, 
as we noted in the CY 2019 HH PPS proposed rule, we consider the home 
infusion benefit principally to be a separate payment in addition to 
the existing payment made under the DME benefit, thus explicitly and 
separately paying for the home infusion therapy services (83 FR 32466). 
Therefore, the professional services covered under the DME benefit are 
not covered under the home infusion benefit. While the two benefits 
exist in tandem, the services are unique to each benefit and billed and 
paid for under separate payment systems.
5. Home Infusion Therapy and the Interaction With Home Health
    In the proposed rule, we discussed the potential for overlap 
between the new home infusion therapy benefit and the home health 
benefit. 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.
    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, we stated 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 is excluded from the consolidated billing requirements 
governing the HH PPS (42 CFR 484.205) and therefore, the DME items and 
services (including the home infusion 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 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.
    Comment: Several commenters expressed concern that home health 
agencies will not be able to bill for the home infusion therapy 
services for beneficiaries under a home health plan of care, unless 
they are also accredited as a home infusion therapy supplier. 
Commenters expressed concern that this is in contrast to the full 
coverage currently available for beneficiaries under the home health 
benefit, and that beneficiaries will now be responsible for a 20 
percent coinsurance. Additionally, commenters stated that the home 
health agency would be responsible for providing the pump, medication, 
and infusion supplies if they did obtain the designation, and expressed 
concern that many HHAs believe that this is outside of their scope of 
practice. Commenters stated that HHAs will restrict the availability of 
infusion services and limit those patients needing infusion services, 
forcing many of these patients to receive their infusions at another 
setting rather than receiving them at home. A commenter recommended 
that the home infusion benefit should only be available for 
beneficiaries who are not homebound, and infusion services for 
otherwise eligible home health beneficiaries should remain under the 
home health benefit.
    Response: We understand commenter concern regarding home infusion 
therapy services under the home health benefit; however, section 5012 
of the 21st Century Cures Act amends section

[[Page 60624]]

1861(m) of the Act to exclude home infusion therapy from home health 
services effective January 1, 2021. Therefore, home infusion therapy 
will no longer be provided to homebound patients under the home health 
benefit. Home infusion therapy services will now be provided under the 
home infusion benefit for both homebound and non-homebound 
beneficiaries. It is also important to note, that the HHA is not 
responsible for furnishing the pump, related supplies, or the infusion 
medication. Further, the HHA is already required to arrange for the DME 
and related infusion services for patients under a home health plan of 
care. In the case that an HHA also becomes accredited as a home 
infusion therapy supplier, the HHA would continue to meet the 
requirements under the Home Health Conditions of Participation (CoPs) 
as well as the home infusion therapy supplier requirements as set out 
in Part 486, Subpart I, of which DME services, including pharmacy 
services associated with the preparation and dispensing of home 
infusion drugs are not included. We acknowledged in the CY 2019 HH PPS 
final rule with comment period that while these services are closely 
related to the home infusion therapy benefit, they remain covered under 
the Part B DME benefit and are not part of the Medicare home infusion 
therapy benefit (83 FR 56563).
6. 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 treatment 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 record before 
establishing the infusion 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. The frequency of 
discussing these options could vary based on a routine scheduled visit 
or according to the individual's clinical needs.
    We solicited comments in the CY 2020 PFS proposed rule (84 FR 
40716), as well as the CY 2020 HH PPS proposed rule (84 FR 34694), 
regarding the appropriate form, manner, and frequency that any 
physician must use to provide notification of the treatment options 
available to his/her patient for the furnishing of infusion therapy 
(home or otherwise) under Medicare Part B. We also solicited comments 
on any additional interpretations of this notification requirement and 
whether this requirement is already being met under the temporary 
transitional payment for home infusion therapy services.
    The following is a summary of the related comments received on both 
solicitations.
    Comment: Several commenters supported the proposed examples of the 
physician verbally discussing the infusion therapy options and 
annotating the resulting decision in the medical record and initial 
plan of care. Many commenters stated that written materials may be a 
helpful supplement to a verbal conversation, but written materials 
should not be the sole means of beneficiary notification. They 
emphasized that infusion therapy options should be verbally discussed 
so the patient, and any family caregiver, may have an opportunity to 
get immediate answers to questions that may not be addressed in written 
materials. Many commenters encouraged CMS to consider minimizing the 
paperwork burden and confusion that written documents or patient 
attestations could impose on physicians and patients.
    Commenters recommended that the conversation should include how the 
infusion therapy options differ in terms of effectiveness, safety, 
time, comfort, convenience, location, frequency, and out-of-pocket 
costs. Some commenters specifically noted that beneficiaries are 
subject to the standard 20 percent coinsurance with this new Part B 
benefit; and the ordering physician should be aware of the patient's 
insurance status and therefore assist them in making informed decisions 
about their care.
    Some commenters recommended the policy should allow for other 
professionals, such as social workers, home health nurses, and other 
staff to assist the treating physician with this notification in order 
to remove unnecessary administrative burden for clinicians. Commenters 
also requested that the notification policy include requirements would 
be simple and easy for physicians to implement, and that would retain 
the current flexibility for physicians to use multiple notification 
mechanisms as directly suggested by beneficiaries, advocates and 
stakeholders.
    One commenter requested that CMS follow similar procedures for 
other electronically prompted beneficiary notifications. Another 
commenter recommended that CMS develop a single standardized format for 
this notice to avoid benefit denials and delays in therapy. Another 
commenter suggested that CMS establish a training program for 
physicians, hospitals and contractors prior to implementation.
    A commenter requested that CMS permit sufficient time for 
physicians to research the available home infusion therapy options. 
Another commenter requested that CMS create a web page where a 
beneficiary or referring clinician can research if there is a home 
infusion therapy supplier in the beneficiary's geographic location that 
is capable of delivering these services, and that the supplier is 
enrolled and approved by Medicare.
    A few commenters asked that this notification be required only when 
the drug regimen is available and appropriate for home infusion 
therapy. They suggested that notification should not be required if 
there are certain safety risks associated with infusion therapy in that 
patient's home or if the home infusion therapy option is not available 
in the patient's geographic area.
    Regarding the frequency of notification, one commenter suggested 
that only one streamlined notice be required at the start of therapy 
because many therapies have a duration for the life of the beneficiary. 
Two commenters specified that notification of options should be 
discussed and documented in the patient record whenever a new infusion 
therapy treatment is deemed necessary by the physician and anytime 
thereafter if there are changes in patient condition or circumstances 
that would affect the patient's choices.
    Response: We appreciate the commenters' support and recommendations 
and will take the comments into consideration as we continue developing 
future policy through notice-and-comment rulemaking effective for home 
infusion therapy services beginning CY 2021 and for subsequent years.

[[Page 60625]]

D. Payment Categories and Amounts for Home Infusion Therapy Services 
for CY 2021

    In the CY 2020 HH PPS proposed rule we discussed section 
1834(u)(1)(A)(i) of the Act, which requires the Secretary 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. Section 1834(u)(1)(B)(ii) of the Act requires the payment 
amount to reflect patient acuity and complexity of drug administration.
    We stated 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. We proposed to maintain the 
three payment categories, with the associated J-codes, utilized 
currently under the temporary transitional payment. We stated that this 
utilizes an already established framework for assigning a unit of 
single payment (per category), accounting for different therapy types, 
which in turn, reflects variations in nursing utilization, complexity 
of drug administration, and patient acuity. We stated that 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 CY 2021. 
Table 30 provides the list of J-codes associated with the infusion 
drugs that fall within each of the payment categories. We also noted 
that there are a few drugs for which services are included under the 
transitional benefit that would not be defined as home infusion drugs 
under the permanent benefit beginning with CY 2021.
BILLING CODE 4120-01-P

[[Page 60626]]

[GRAPHIC] [TIFF OMITTED] TR08NO19.047

BILLING CODE 4120-01-C
    We stated in the proposed rule that 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 ``single payment 
amounts'' for the temporary transitional payments for home infusion 
therapy services. We also reiterated that a ``single payment amount'' 
for an infusion drug administration calendar day 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 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 proposed to carry forward the payment 
methodology as outlined in section 1834(u)(7)(A) of the Act for the 
temporary transitional payments. We proposed 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. 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 proposed 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, rather than retaining the current rate 
under the temporary transitional payment, equal to 4 hours. We stated 
that 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. We

[[Page 60627]]

stated that setting the payment amount at the maximum amount allowed by 
statute would reflect the varying degrees of care among individual 
patients within each category and from visit to visit for the same 
patient. It would also ensure that payment for home infusion therapy 
services adequately covers the different patient care needs and level 
of complexity of services provided, while remaining a unit of single 
payment. While the single unit of payment for the temporary 
transitional payments was set at 4 hours by law, the law for the 
permanent benefit provides more latitude for home infusion therapy 
services payments beginning in CY 2021. We stated that furnishing care 
in the patient's home is fundamentally different from furnishing care 
in the physician's office due to healthcare professionals being unable 
to achieve the economies of scale in the home that can be achieved in 
an office setting. Therefore, the single unit of payment is a bundle 
that 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 payment rates for 
each of the three payment categories are higher than the home health 
per-visit nursing rate of $149.68, the rate for medical social services 
is $239.92. As we did not limit this benefit to only nursing visits, 
the home infusion therapy rates for subsequent visits are comparable to 
the home health per visit amounts. The home infusion therapy rates 
reflect the increased complexity of the professional services provided 
per category, and as required by law. We continue to believe that 
increasing the payment amount to 5 hours will better account for all of 
the home infusion therapy services covered under the benefit, including 
nursing; training and education; remote monitoring; and monitoring 
provided on an infusion drug administration calendar day.
    We also stated that 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. 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. We explained that one component used to value the CPT 
code, the non-facility practice expense relative value unit (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, and that 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.
    We also recognized 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 
accordance with section 1834(u)(1)(C) of the Act, which 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, we proposed 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. We stated 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, and that 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. 
We stated that 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 recognized 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, we 
stated that 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.
    And finally, we stated that 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.
    The following is a summary of the comments received on the proposed 
CY 2021 home infusion therapy categories and payment amounts, and our 
responses:
    Comment: A few commenters' stated that the proposed categories do 
not necessarily reflect the acuity or complexity of drug 
administration. These commenters did not suggest other methods for 
grouping drugs but recommended that CMS reimburse all home infusion 
professional services at the proposed rate for payment category 3 (1 
hour at CPT 96413 and 4 hours at CPT 96415). MedPAC recommended that 
CMS use 2019 home infusion therapy claims data to evaluate the three 
categories and consider whether modifications to the three categories 
are appropriate in next year's proposed rule.
    Response: While commenters' did not provide a rationale as to why 
they believe all infusion drug administration calendar days should be 
paid at the payment category 3 rate, it is important to reiterate that 
CMS is required to account for varying therapy types under the payment 
system. Section 1834(u) of the Act requires the Secretary to implement 
a payment system under which a single payment is made to a home 
infusion therapy supplier for the items and services (professional 
services, including nursing services; training and education; remote 
monitoring, and other monitoring services), beginning January 1, 2021. 
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. 
Paying a single payment amount at the category 3 rate for the 
professional services for all home infusion drugs

[[Page 60628]]

would not take into account types of infusion therapy, including the 
variation in utilization of nursing services, patient acuity, and 
complexity of drug administration.
    We appreciate MedPAC's suggestion to evaluate the three categories 
and consider whether modifications are appropriate for next year's 
rule. We will continue to monitor home infusion utilization using the 
temporary transitional payment claims data, including visit length. If 
adjustments to any of the home infusion therapy provisions are 
warranted based on this data analysis, we will address such changes in 
future rulemaking.
    Comment: A commenter stated that the CPT description for the 
category three CPT codes are more expansive than only chemotherapy 
drugs, and noted that it can be used for ``injection and intravenous 
infusion chemotherapy and other highly complex drug or highly complex 
biologic agent administration.''
    Response: We recognize that the CPT code associated with payment 
category 3 home infusion drugs also includes other highly complex drugs 
and biologicals; however, currently the only drugs on the LCD for 
External Infusion Pumps (L33794) that are appropriate for this category 
are the cancer chemotherapy drugs. In the event that additional drugs 
or biologicals are added to the DME LCD, then potentially more drugs 
and biologicals (other than cancer chemotherapy drugs) would be 
included in payment category 3.
    Comment: The majority of commenters supported the 5 hour payment 
rate; however, these commenters continued to disagree with the 
definition of ``infusion drug administration calendar day.'' Several 
commenters also stated they would support retaining the three payment 
categories and the rates that were established in the Bipartisan Budget 
Act of 2018 if CMS were to pay on each day the patient receives an 
infusion drug, regardless of whether a professional is in the home. 
MedPAC disagreed with the increase from a 4 hour payment rate to a 5 
hour payment rate without sufficient evidence that this increase is 
warranted, or that increasing the aggregate level of payment to the 
maximum level permitted by statute is an appropriate approach for 
addressing variation in costs across patients. MedPAC also suggested 
considering other approaches to address variation in costs such as 
developing a payment adjuster for patient acuity or complexity of drug 
administration.
    Response: We thank the commenters for their support for setting the 
payment rate to 5 hours of infusion in a physician's office. We believe 
that 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. We understand MedPAC's concern regarding the lack of evidence 
that such an increase in the number of hours is warranted. However, 
because the home infusion therapy payment must take into account, as 
appropriate, types of infusion therapy, including variations in 
utilization of services by therapy type, yet remain a single payment 
amount, we do believe that setting the payment rate to the maximum 
amount set in statute recognizes the variety and amount of services 
included in the payment. Also, because we are implementing a payment 
system for a new Medicare benefit, we do not have sufficient data in 
order to examine situations for which payment adjustment (for example, 
a case-mix adjustment system) may be appropriate. As previously 
discussed, we plan to continue to monitor visit length in order to 
determine if adjustments in the payment methodology are needed. 
However, as we do not collect cost report data for suppliers, it is 
unclear how we would be able to evaluate data regarding variations in 
cost across patients.
    We remind commenters that we finalized the definition of ``infusion 
drug administration calendar day'' in the CY 2019 HH PPS final rule 
with comment period (83 FR 56583) and we did not propose changes to 
this definition in the CY 2020 HH PPS proposed rule. Our responses to 
additional comments received on the CY 2019 HH PPS final rule with 
comment period with regard to this definition are addressed in section 
VI.C.1. of this final rule with comment period. Therefore, payment for 
home infusion therapy services beginning in CY 2021 will be for those 
days on which a skilled professional is in the patient's home 
furnishing home infusion therapy services during a day of drug 
administration.
    Comment: Commenters were overwhelmingly in support of the proposed 
payment adjustment for the first visit. Commenters appreciated the 
recognition that new patients require more time and education. A 
commenter agreed that it is reasonable to expect that the first home 
infusion therapy visit will have higher associated costs, but 
encouraged CMS to examine claims data as it becomes available in order 
to determine an appropriate payment rate for the first versus 
subsequent visits.
    Response: We thank commenters for their support of this proposal, 
and as previously stated, do plan on monitoring visit lengths in order 
to determine if the data substantiates this adjustment.
    Comment: A few commenters recommended collecting the data necessary 
to construct a permanent rate that reflects the complexity and duration 
of services necessary to deliver home infusion therapy, will 
incentivize the delivery of safe, effective, high-quality care, and 
will inform future policy discussions as new and emerging medications 
become available.
    Response: We appreciate commenters' recommendations and will 
consider them for the future as well as continue to monitor home 
infusion therapy utilization through the collection and analysis of 
claims data as previously discussed.
    Final Decision: We are finalizing our proposal to maintain the 
three payment categories currently being utilized under the temporary 
transitional payments for home infusion therapy services. We are 
finalizing that each category payment amount will be in accordance with 
the six CPT infusion codes under the PFS and equal to 5 hours of 
infusion services in a physician's office. And finally, we are 
finalizing our proposal to increase 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, in a budget neutral manner, resulting in a small decrease to the 
payment amounts for any subsequent visits. Payment will be made for 
each infusion drug administration calendar day in accordance with the 
definition finalized in the CY 2019 final rule with comment period (83 
FR 56583). We will continue to evaluate the home infusion therapy 
benefit and if appropriate and within the scope of our statutory 
authority, make adjustments to the payment methodology to maximize 
utilization of the home infusion therapy benefit, while protecting the 
integrity of the Medicare program.
    In response to stakeholder concerns regarding the limitations of 
the DME LCDs for external infusion pumps that preclude coverage to 
certain infused drugs, we seek comments on the criteria CMS could 
consider to allow coverage of additional drugs under the DME benefit. 
In order for a drug to be covered as a supply under the Medicare DME 
benefit, the drug itself must require administration through an 
external infusion pump. Under this benefit, the DME Supplier Standards 
require that

[[Page 60629]]

the supplier train the patient and/or caregiver to operate the 
equipment safely and effectively in the home. As such, the patient and/
or caregiver must be able to use the equipment on his/her own. For this 
reason, the DME LCDs for External Infusion Pumps do not currently 
include drugs that the patient and/or caregiver would not be able to 
infuse in the home without a healthcare professional present. However, 
given the new permanent home infusion therapy benefit to be implemented 
beginning January 1, 2021, which includes payment for professional 
services, including nursing; we are soliciting comments on options to 
enhance future efforts to improve policies related to coverage of 
eligible drugs for home infusion therapy (for example, whether coverage 
could include instances where diseases or conditions prevent a patient 
from being able to self-infuse, such as due to a neurodegenerative 
disease). We believe that any changes to the DME and home infusion 
therapy benefits must first ensure that the DME and supplies covered 
fall within the scope of the DME benefit, and also balance concerns of 
promoting access to innovative treatments with patient safety and cost-
efficient delivery and monitoring of drug infusions relative to the 
facility setting (for example, physician office or hospital outpatient 
department).
    Table 31 shows the payment categories with the CPT codes and units 
for such codes for home infusion therapy services in CY 2021 and 
subsequent calendar years. Table 32 illustrates the 5-hour payment 
rates (using the proposed CY 2020 PFS amounts) reflecting the increased 
payment for the first visit and the decreased payment for all 
subsequent visits. The actual home infusion payment rates will be 
updated in next year's rule using the CY 2021 PFS amounts.
[GRAPHIC] [TIFF OMITTED] TR08NO19.048

[GRAPHIC] [TIFF OMITTED] TR08NO19.049

E. Required Payment Adjustments for CY 2021 Home Infusion Therapy 
Services

1. 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 stated that we 
determined that the geographic adjustment factor (GAF) is a more 
appropriate option to adjust home infusion therapy payments based on 
differences in geographic area 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).\228\ The work GPCI reflects the relative costs of 
physician labor by region. The PE GPCI measures the

[[Page 60630]]

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:
---------------------------------------------------------------------------

    \228\ GAF = (.50886 x Work GPCI) + (.44839 x PE GPCI) + (.04295 
x MP GPCI).
[GRAPHIC] [TIFF OMITTED] TR08NO19.050

    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 final rule with comment 
period 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 such as the 
hospital wage index (HWI), the GPCI, and using just the practice 
expense component of the GPCI. However, we proposed use of the GAF to 
geographically wage adjust home infusion therapy for CY 2021 and 
subsequent years. We stated that the GAF is the best option for 
geographic wage adjustment, as 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. The GAF is further 
discussed in the CY 2017 PFS final rule (81 FR 80170). The final CY 
2020 and CY 2021 GAF values for each payment locality, when available, 
will be posted along with the final rule with comment period at: 
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-
Center.html.
    We proposed that the application of the geographic wage adjustment 
be budget neutral so there is no overall cost impact. However, this 
results 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 will 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 received a comment that supported the use of geographic 
adjustment for the home infusion therapy benefit in CY 2021; however, 
we did not receive any comments specifically regarding the use of the 
GAF, or any other wage adjustment, to geographically adjust the home 
infusion therapy payment amounts.
    Comment: A commenter stated support for the use of geographic 
payment indexing to ensure that in higher cost markets, reimbursement 
is in line with expenses.
    Response: We appreciate the commenter's support, and will note that 
geographic adjustment is a statutory requirement for the home infusion 
therapy benefit beginning in CY 2021.
    Final Decision: We are finalizing our proposal to use the GAF to 
geographically adjust the home infusion therapy payment amounts in CY 
2021 and subsequent calendar years.
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 
stated that 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.\229\ Prior authorization helps to ensure that a 
service, such as home infusion therapy, is being provided 
appropriately.
---------------------------------------------------------------------------

    \229\ Preauthorization. https://www.healthcare.gov/glossary/preauthorization/.
---------------------------------------------------------------------------

    In the CY 2020 HH PPS proposed rule (84 FR 34701), we discussed 
comments received on the CY 2019 HH PPS proposed rule solicitation of 
comments regarding whether and how prior authorization could 
potentially be applied under the home infusion benefit. We noted that 
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 therapy.
    Ultimately, we agreed with commenters and stated that 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. We 
stated that we will monitor

[[Page 60631]]

the provision of home infusion therapy services and revisit the need 
for prior authorization if issues arise.
    We received a few comments on the CY 2020 HH PPS proposed rule 
regarding the use of prior authorization for the home infusion therapy 
benefit in CY 2021:
    Comment: A commenter stated that requiring prior authorization from 
the prescriber for home infusion therapy services will not improve the 
safety or efficacy of care, as site of care choices in this context are 
only initiated by the prescribing physician. The commenter stated that 
the home infusion therapy supplier cannot unilaterally switch the care 
setting, and stated that further mandating prior authorization only 
delays initiation of home infusion therapy for the patient and adds 
administrative burden and costs to the process. Another commenter 
stated that implementing prior authorization for home infusion therapy, 
or any other home health service would be a duplication of physician 
effort (who have already determined reasonable and necessary), may 
result in delay of care, and potentially lead to a prior denial for 
legitimate care.
    Response: We thank the commenters for their comments. As stated 
previously, we agree that prior authorization is not necessary for home 
infusion therapy at this time, but will continue to 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 2020 HH PPS proposed rule 
(84 FR 34701) we discussed comments received on the CY 2019 HH PPS 
proposed rule, regarding situations that may incur an outlier payment 
and potential designs for an outlier payment calculation. We stated 
that we planned to monitor the need for such payment and if necessary 
address outlier situations in future rule making. We received a comment 
regarding outliers for home infusion therapy services.
    Comment: MedPAC suggested that although it may be premature to 
develop a system of outliers, developing such a system would be 
preferable to increasing aggregate payments for the purpose of 
addressing cost variation.
    Response: We thank MedPAC for this recommendation and will pay 
close attention to any situations that would potentially be appropriate 
for an outlier payment, and if necessary address these situations in 
future rulemaking.

G. Billing Procedures for CY 2021 Home Infusion Therapy Services

    Finally, in the CY 2020 HH PPS proposed rule we discussed billing 
procedures for home infusion therapy services for CY 2021 and 
subsequent years. We stated that because 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, the qualified 
home infusion therapy supplier will 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 home infusion therapy professional 
services to the A/B MAC. We stated that 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. We also plan to add the home 
infusion G-codes to the PFS, incorporating the required annual and 
geographic wage adjustments. Home infusion therapy suppliers will 
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. We will issue a Change 
Request (CR) providing more detailed instruction regarding billing and 
policy information for home infusion therapy services, prior to 
implementation of the CY 2021 home infusion benefit.
    Comment: Several commenters had concerns about the home infusion 
therapy supplier enrollment process with the A/B MACs, as the majority 
of suppliers are only enrolled as DME suppliers and only bill the DME 
MACs. They stated that the 855B A/B enrollment form does not include a 
category for ``home infusion therapy supplier'' and urged CMS to offer 
enrollment guidance. Commenters also pointed out that the DME supplier 
is not required to be in the same state as the patient, which allows 
the supplier to distribute drugs and supplies across a broad 
geographical region, thereby allowing continued service for Medicare 
beneficiaries who spend parts of the year in different states. They 
encouraged CMS to ensure that home infusion therapy suppliers are able 
to enroll in such a way that they can identify their pharmacy as a 
practice location and base-operation from which they schedule and 
dispatch nursing related home infusion services; allow for 
jurisdictional enrollment and billing of HIT services without the 
requirement to have a physical location within the jurisdiction; and 
allow for DME suppliers, also accredited as qualified home infusion 
therapy suppliers, to complete a single A/B MAC application identifying 
all areas that they schedule and dispatch the nursing component of home 
infusion therapy.
    Response: We thank commenters for their review of the billing 
procedures outlined in the proposed rule. We recognize that the 
enrollment process will be new for the DME suppliers enrolling 
concurrently as home infusion therapy suppliers; however, we encourage 
commenters not to conflate DME suppliers with home infusion therapy 
suppliers. The DME taxonomy code, which, as the commenter pointed out, 
allows for pharmacy-based, decentralized patient care that does not 
require a physical brick-and mortar location, will not be affected by 
the requirement for home infusion therapy suppliers enrollment through 
the A/B MACs. DME suppliers are not required to enroll with the A/B 
MACs but instead they will continue to enroll with the National 
Supplier Clearinghouse, and their billing processes for equipment and 
supplies, including infusion drugs, will not change. Only if they 
become accredited as a home infusion therapy supplier, would they 
complete an additional enrollment with the A/B MACs in order to submit 
home infusion therapy service claims. We do understand that some 
current DME suppliers enrolling as home infusion therapy suppliers may 
not have brick-and-mortar locations per the A/B MAC requirements; 
however, and plan to issue more complete guidance for these providers.
    We also recognize there is currently not a ``home infusion therapy 
supplier'' type on the 855B enrollment form, and

[[Page 60632]]

are considering creating one for home infusion supplier enrollment. In 
the meantime, providers can enroll using the ``other'' option. We are 
currently examining and working on all other aspects of the enrollment 
process and appreciate and will take all commenter suggestions under 
consideration as we continue developing guidance for suppliers.

VII. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment before the provisions of a 
rule take effect in accordance with section 553(b) of the 
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can 
waive this notice and comment procedure if the Secretary finds, for 
good cause, that the notice and comment process is impracticable, 
unnecessary, or contrary to the public interest, and incorporates a 
statement of the finding and the reasons therefore in the rule. This 
home health proposed rule has previously been subjected to notice and 
comment procedures. These corrections do not make substantive changes 
to this policy. Specifically, we amended the definition of ``applicable 
provider'' at Sec.  486.505 to read ``nurse practitioner'' rather than 
``nurse provider.'' Additionally, we amended Sec.  414.1550(a)(1) and 
(2) to include ``or service''. The specific changes we are making in 
the regulations are simply technical corrections in the language and do 
not reflect any additional substantive changes. Therefore, we find that 
undertaking further notice and comment procedures to incorporate these 
corrections into the CY 2020 final rule with comment period is 
unnecessary and contrary to the public interest.
    Additionally, we are finalizing the submission of a ``no-pay'' RAP 
within five calendar days after the start of each 30-day period of care 
for CY 2021. We are also finalizing to apply a payment reduction if the 
``no-pay'' RAP is not submitted timely. These changes were not proposed 
in the proposed rule, however, we are adopting the change here under a 
``good cause'' waiver of proposed rulemaking. The specific changes we 
are making are in accordance with the proposed NOA policy for CY 2021. 
However, we are delaying the submission of a NOA until CY 2022 to allow 
sufficient time to make system changes to accommodate the NOA process. 
We note that if the NOA policy would have been finalized for CY 2021, 
the payment reduction for an untimely filed NOA would also be applied. 
Therefore, finalizing a ``no-pay'' RAP policy, as opposed to a NOA 
policy, with an untimely submission payment reduction in CY 2021 does 
not reflect any additional substantive changes to what was proposed. 
Therefore, we find that undertaking further notice and comment 
procedures to incorporate this correction into the final rule with 
comment period is unnecessary and contrary to the public interest.

VIII. 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 final rule with comment period, we are 
finalizing our proposed updates to the HH QRP with the exception of the 
removal of Question 10 from all HHCAHPS survey as discussed in Section 
V.K. We believe that the burden associated with the HH QRP provisions 
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 2018 National Occupational Employment and Wage 
Estimates (https://www.bls.gov/oes/current/oes_nat.htm). To account for 
overhead and fringe benefits (100 percent), we have doubled the hourly 
wage. These amounts are detailed in Table 33.
[GRAPHIC] [TIFF OMITTED] TR08NO19.051

    As discussed in section V.D. of this final rule with comment 
period, we are finalizing the removal of 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 finalized the 
removal of 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.
    As discussed in section V.E. of this final rule with comment 
period, we are finalizing the adoption of 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 Transfer of Health Information

[[Page 60633]]

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 final rule with comment period, we are 
finalizing the collection of standardized patient assessment data 
beginning with the CY 2022 HH QRP. We estimate the 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 10.95 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 11.25 minutes at Discharge as a result of the HH 
QRP proposals finalized in this 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 $74.58, inclusive 
of fringe benefits, using the hourly wage data in Table 33. Individual 
providers determine the staffing resources necessary.
    Table 34 shows the total number of OASIS assessments submitted by 
HHAs in CY 2018 and estimated burden at each time point.
[GRAPHIC] [TIFF OMITTED] TR08NO19.052

    Based on the data in Table 34, 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 
$15,081.76 per HHA annually, or $171,705,794.10 for all HHAs annually. 
This corresponds to an estimated increase in clinician burden 
associated with changes to the HH QRP of approximately 202.2 hours per 
HHA annually, or 2,302,303.5 hours for all HHAs annually. This 
estimated increase in burden will be accounted for in the information 
collection under OMB control number 0938-1279.

IX. 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 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

[[Page 60634]]

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 heath 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, and is not reflective of cost estimates for CY 
2020.
    Section 50401 of the BBA of 2018 amended section 1834(u) of the 
Act, by adding a new paragraph (7). The paragraph 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 
final rule with comment period), 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 continues 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).
    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.
    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 final rule with 
comment period:
     HH PPS--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). This reflects the effects of the CY 2020 home health 
payment update percentage of 1.5 percent ($290 million increase), and a 
0.2 percent decrease in payments due to the rural add-on percentages 
mandated by the Bipartisan Budget Act of 2018 for CY 2020 ($40 million 
decrease). The home health wage index update for CY 2020 and the 
updated FDL ratio that will be used for outlier payments in CY 2020 are 
both budget-neutral.
     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 policy finalized in this final rule with comment period 
would affect the prior estimate.
     HH QRP--The cost impact for HHA's related to proposed 
changes to the HH QRP are estimated at $167.8 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 an estimated 1.9 percent, or $1.2 
million, decrease in payments to home infusion therapy suppliers in CY 
2020 based on the proposed CY 2020 Physician Fee Schedule (PFS) payment 
amounts for such services (the final CY 2020 PFS payment amounts were 
not available in time for this final rule with comment period). The 
cost impact in CY 2021 related to the implementation of the permanent 
home infusion therapy benefit is estimated to be a $2 million reduction 
in payments to home infusion therapy suppliers.

[[Page 60635]]

C. Anticipated Effects

1. HH PPS and Home Infusion Therapy
    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 in this final rule with comment period will 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 
final rule with comment period will have a significant economic impact 
on a substantial number of small entities. We refer stakeholders to 
Tables 35 and 36 which contain some information on the numbers of small 
entities impacted by the rule.
    In addition, section 1102(b) of the Act requires us to prepare a 
final RIA if a rule has a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 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 with comment period 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 final rule with comment period 
under these criteria of Executive Order 13132, and have determined that 
it will not impose substantial direct costs on state or local 
governments.
    One commenter expressed concerns that CMS is not considering the 
requirements of the Regulatory Flexibility Act or the Small Business 
Regulatory Enforcement Fairness Act, which limits the impact on small 
businesses. We refer commenters to section III.B. of this final rule 
with comment period for our response to this comment.
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 policy that we are finalizing will affect the prior estimate.
3. HH QRP
    Section VIII. of this final rule with comment period provides a 
detailed description of the net increase in burden associated with 
changes to the HH QRP. 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 $171.7 million in annualized cost 
to HHAs, discounted at 7 percent relative to year 2016, over a 
perpetual time horizon beginning in CY 2021.
4. Regulatory Review Cost Estimation
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule with 
comment period, 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 final rule with comment 
period would be the similar to the number of reviewers on last year's 
final rule with comment period. 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 with comment 
period 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 also recognize that different types of 
entities are in many cases affected by mutually exclusive sections of 
this final rule with comment period, and therefore for the purposes of 
our estimate we assume that each reviewer reads approximately 50 
percent of the rule. While we solicited comments on the approach in 
estimating the number of entities which would review the proposed rule 
and the assumption of how much of the rule reviewers would read, we did 
not receive any comments. Therefore, 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 with comment period 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 5 
hours for the staff to review half of this final rule with comment 
period, which consists of approximately 152,000 words. For each HHA 
that reviews the final rule with comment period, the estimated cost is 
$546.80 (5 hours x $109.36). Therefore, we estimate that the total cost 
of reviewing this final rule with comment period is $292,632 ($546.80 x 
537 reviewers).

[[Page 60636]]

D. Detailed Economic Analysis

1. HH PPS
    This final rule with comment period finalizes updates to Medicare 
payments under the HH PPS for the CY 2020. This rule with comment 
period also implements changes 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. The impact analysis of this final rule with comment 
period presents the estimated expenditure effects of policy changes 
finalized 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. 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 35 represents how HHA revenues are likely to be affected by 
the policy changes 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 (as 
of July 31, 2019). The first column of Table 35 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 finalized in this rule with 
comment period.
    Overall, it is projected that aggregate payments in CY 2020 would 
increase by 1.3 percent. As illustrated in Table 35, 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.

[[Page 60637]]

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[[Page 60638]]


[GRAPHIC] [TIFF OMITTED] TR08NO19.054

2. HHVBP
    As discussed in section IV. of this final rule with comment period, 
for the HHVBP Model, we proposed and are finalizing the public 
reporting of certain performance data for PY 5 (CY 2020) of the Model. 
This finalized policy does not affect our analysis of the distribution 
of payment adjustments for PY 5 as presented in the CY 2019 HH PPS 
final rule with comment period. 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 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 final rule with comment 
period, we proposed to remove one measure beginning with the CY 2022 HH 
QRP. The measure we proposed to remove is Improvement in Pain 
Interfering with Activity Measure (NQF #0177). As discussed in section 
V.E. of this final rule with comment period, we proposed to add two 
measures beginning with the CY 2022 HH QRP. The two measures we 
proposed 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 final rule with 
comment period, we are also proposed to collect standardized patient 
assessment data beginning with the CY 2022 HH QRP. Section VII. of this 
final rule with comment period 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

[[Page 60639]]

be a net increase of approximately $167.8 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
    The impact due to the updated payment amounts for furnishing home 
infusion therapy services is determined based on the rates published in 
the physician fee schedule established under section 1848 of the Act. 
At the time of publication of this final rule with comment period, the 
CY 2020 PFS final payment rates were not available. However, we 
estimate the impact in CY 2020, based on the CY 2020 PFS proposed 
rates, would result in a 1.9 percent decrease in overall payments for 
home infusion therapy suppliers receiving temporary transitional 
payments.
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 2021. We used CY 2018 claims data to 
identify beneficiaries with DME claims containing 1 of the 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 insulin, 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 with comment 
period. 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 CY 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. 
Additionally for these categories, 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 category 2, we 
assumed 1 visit per month, or 12 visits per year. 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 will 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 during the 
temporary transitional payment period, and once the permanent benefit 
is implemented in CY 2021.
    Table 36 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 2020 transitional 
payment to the estimated CY 2021 payment after applying the geographic 
adjustment factor (GAF). Column 4 represents the percent change from 
the estimated CY 2021 payment after applying the GAF to the estimated 
CY 2021 payment after removing the statutorily excluded drugs and 
biologicals. Column 5 represents the percent change from the estimated 
CY 2021 payment after applying the GAF and removing the statutorily 
excluded drugs and biologicals to the estimated CY 2021 payment, and 
after applying the higher reimbursement rate. Overall, we estimate a 
3.6 percent decrease ($2 million) in payments to home infusion therapy 
suppliers in CY 2021.
BILLING CODE 4120-01-P

[[Page 60640]]

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BILLING CODE 4120-01-C

E. Alternatives Considered

1. HH PPS
    This final rule with comment period contains a range of policies, 
including some provisions related to specific statutory provisions. The 
preceding preamble provides descriptions of the statutory provisions 
that are addressed, identifies those policies when discretion has been 
exercised, presents rationale for our final policies and, where 
relevant, alternatives that were considered.
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, for the reasons discussed in section IV. of this final rule 
with comment period, we are finalizing the public reporting of the 
HHVBP Model performance data for PY 5 as proposed. 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

[[Page 60641]]

Annual Reports to HHAs. As discussed in section IV of this final rule 
with comment period, 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 proposed 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 provision.
    The finalization of 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 addressed 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
    This final rule with comment period contains a range of policies, 
including some provisions related to specific statutory provisions. The 
preceding preamble provides descriptions of the statutory provisions 
that are addressed, identifies those policies when discretion has been 
exercised, presents rationale for our final policies and, where 
relevant, alternatives that were considered.

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 37, 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 38 shows the burden to HHA's 
for submission of OASIS. Table 39 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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[[Page 60642]]


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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 final rule with comment period 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. This reflects the effects of 
the CY 2020 home health payment update percentage of 1.5 percent ($290 
million increase), and a 0.2 percent decrease in payments due to the 
declining rural add-on percentages mandated by the Bipartisan Budget 
Act of 2018 for CY 2020 ($40 million decrease). The home health wage 
index update for CY 2020 and the updated FDL ratio that will be used 
for outlier payments in CY 2020 are both budget-neutral. Effects of the 
implementation of the PDGM and the change to a 30-day unit of payment 
are also budget-neutral.
2. HHVBP
    In conclusion, as noted previously for the HHVBP Model, we are 
finalizing our proposal to publicly report performance data for PY 5 
(CY 2020) of the Model. This finalized policy does not affect our 
analysis of the distribution of payment adjustments for PY 5 as 
presented in the CY 2019 HH PPS final rule with comment period.
    We estimate there would be no net impact (to include either a net 
increase or reduction in payments) for this final rule with comment 
period 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 changes to the HH QRP effective on 
January 1, 2021 result in a net additional annualized cost of $167.8 
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 a 1.9 percent, or $1.2 million, decrease 
in payments to home infusion therapy suppliers in CY 2020 based on the 
proposed CY 2020 Physician Fee Schedule (PFS) payment amounts for such 
services established under section 1848 of the Act (the final CY 2020 
PFS payment amounts were not available in time for this final rule with 
comment period).
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 $2 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 
final rule with comment period 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.

42 CFR Part 486

    Grant programs--health, Health facilities, Medicare, Reporting and 
recordkeeping requirements, X-rays.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 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:

[[Page 60643]]

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 complexity of the therapy 
services required--
    (1) Involve the use of complex and sophisticated therapy procedures 
to be delivered by the therapist or the 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 
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)(1).


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 the following requirements:
    (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 or service.
    (2) The fee schedule amount for the item or service, 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. (i) 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 medicare equipment local coverage determination (DME LCD) for 
external infusion pumps.
    (ii) Payment equals 1 unit of 96365 plus 4 units of 96366.
    (2) Category 2. (i) Includes certain subcutaneous infusion drugs 
for therapy or prophylaxis, including certain subcutaneous 
immunotherapy infusions.
    (ii) 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

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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:
    (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 (d)(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 the 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 1395(hh) 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.
* * * * *

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8. Section 484.205 is amended by--
0
a. Revising paragraph (g)(2);
0
b. Adding paragraphs (g)(3) and (4);
0
c. Revising the heading for paragraph (h); and
0
d. Adding paragraphs (i) and (j).
    The revisions and additions read as follows:


Sec.  484.205  Basis of payment.

* * * * *
    (g) * * *
    (2) Split percentage payments for periods beginning on or after 
January 1, 2020 through December 31, 2020--(i) HHAs certified for 
participation 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. Split percentage payments are not made to HHAs that 
are certified for participation in Medicare effective on or after 
January 1, 2019. Newly enrolled HHAs must submit a request for 
anticipated payment, which is set at 0 percent, at the beginning of 
every 30-day period. 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) Split percentage payments for periods beginning on or after 
January 1, 2021 through December 31, 2021. All HHAs must submit a 
request for anticipated payment within 5 calendar days after the start 
of care date for initial 30-day periods and within 5 calendar days 
after the ``from date'' for each subsequent 30-day period of care, 
which is set at 0 percent at the beginning of every 30-day period. HHAs 
receive a single payment for a 30-day period of care after the final 
claim is submitted.
    (4) Payments for periods beginning on or after January 1, 2022. All 
HHAs must submit a Notice of Admission (NOA) at the beginning of the 
initial 30-day period of care as described in paragraph (j) of this 
section. HHAs receive a single payment for a 30-day period of care 
after the final claim is submitted.
    (h) Requests for anticipated payment (RAP) for 30-day periods of 
care starting on January 1, 2020 through December 31, 2020. * * *
    (i) Submission of RAPs for CY 2021--(1) General. All HHAs must 
submit a RAP, which is to be paid at 0 percent, within 5 calendar days 
after the start of care and within 5 calendar days after the ``from 
date'' for each subsequent 30-day period of care.
    (2) Criteria for RAP submission for CY 2021. The HHA shall submit 
RAPs only when all of the following conditions are met:
    (i) Once physician's written or verbal orders that contain the 
services required for the initial visit have been received and 
documented as required at Sec. Sec.  484.60(b) and 409.43(d) of this 
chapter.
    (ii) The initial visit within the 60-day certification period must 
have been made and the individual admitted to home health care.
    (3) Consequences of failure to submit a timely RAP. When a home 
health agency does not file the required RAP for its Medicare patients 
within 5 calendar days after the start of each 30-day period of care--
    (i) Medicare does not pay for those days of home health services 
based on the ``from date'' on the claim to the date of filing of the 
RAP;
    (ii) The wage and case-mix adjusted 30-day period payment amount is 
reduced by 1/30th for each day from the home health based on the ``from 
date'' on the claim until the date of filing of the RAP;
    (iii) No LUPA payments are made that fall within the late period;
    (iv) The payment reduction cannot exceed the total payment of the 
claim; and
    (v)(A) The non-covered days are a provider liability; and
    (B) The provider must not bill the beneficiary for the non-covered 
days.
    (4) Exception to the consequences for filing the RAP late. (i) CMS 
may waive the consequences of failure to submit a timely-filed RAP 
specified in paragraph (i)(3) 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)(3) 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.

[[Page 60645]]

    (D) Other situations determined by CMS to be beyond the control of 
the home health agency.
    (j) Submission of Notice of Admission (NOA)--(1) For periods of 
care that begin on and after January 1, 2022. For all 30-day periods of 
care after January 1, 2022, all HHAs must submit a Notice of Admission 
(NOA) to their Medicare contractor within 5 calendar days after the 
start of care date. The NOA is a one-time submission to establish the 
home health period of care and covers contiguous 30-day periods of care 
until the individual is discharged from Medicare home health services.
    (2) Criteria for NOA submission. In order to submit the NOA, the 
following criteria must be met:
    (i) Once a physician's written or verbal orders that contains the 
services required for the initial visit have been received and 
documented as required at Sec. Sec.  484.60(b) and 409.43(d) of this 
chapter.
    (ii) The initial visit must have been made and the individual 
admitted to home health care.
    (3) 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 and case-mix 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 of filing of 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; and
    (v)(A) The non-covered days are a provider liability; and
    (B) The provider must not bill the beneficiary for the non-covered 
days.
    (4) 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 (j)(3) 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 (j)(3) 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); and
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, an 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.
    (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 to CMS 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 the requirements in this paragraph 
(b)(1)(iii)(C) are approved by CMS.
    (D) Disapproval by CMS. No organization, firm, or business that 
owns, operates, or provides staffing for an 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 are 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 paragraph (b) of this section must be 
submitted in the form and manner, and at a time, specified by CMS.
    (c) Exceptions and extension requirements. (1) An 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) An HHA may request an exception or extension within 90 days of 
the date that the extraordinary circumstances occurred by sending an 
email to CMS HHAPU reconsiderations at 
[email protected] that contains all of the following 
information:
    (i) HHA CMS Certification Number (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) 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

[[Page 60646]]

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 an 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 the CMS-designated data submission 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 as stated in the 
non-compliance letter.
    (vi) Reason(s) for requesting reconsideration, including all 
supporting documentation.
    (3) CMS does not consider a reconsideration request unless the HHA 
has complied fully with the submission requirements in paragraphs 
(d)(1) and (2) of this section.
    (4) CMS makes a decision on the request for reconsideration and 
provide notice of the decision to the HHA 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.

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS

0
 13. The authority citation for part 486 continues to read as follows:

     Authority: 42 U.S.C. 1302 and 1395hh.


0
 14. Section 486.505 is amended by revising the definition of 
``Applicable provider'' to read as follows:


Sec.  486.505  Definitions.

* * * * *
    Applicable provider means a physician, a nurse practitioner, and a 
physician assistant.
* * * * *

    Dated: October 24, 2019.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.
    Dated: October 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-24026 Filed 10-31-19; 4:15 pm]
BILLING CODE 4120-01-P