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, 34598-34715 [2019-14913]

Agencies

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

[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Proposed Rules]
[Pages 34598-34715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14913]



[[Page 34597]]

Vol. 84

Thursday,

No. 138

July 18, 2019

Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 409, 414, and 484





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

Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / 
Proposed Rules

[[Page 34598]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 414, and 484

[CMS-1711-P]
RIN 0938-AT68


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

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would update the home health prospective 
payment system (HH PPS) payment rates and wage index for CY 2020; 
implement the Patient-Driven Groupings Model (PDGM), a revised case-mix 
adjustment methodology, for home health services beginning on or after 
January 1, 2020. This proposed rule also implements a change in the 
unit of payment from 60-day episodes of care to 30-day periods of care, 
as required by section 51001 of the Bipartisan Budget Act of 2018, 
hereinafter referred to the ``BBA of 2018'', and proposes a 30-day 
payment amount for CY 2020. Additionally, this proposed rule proposes 
to: Modify the payment regulations pertaining to the content of the 
home health plan of care; allow physical therapy assistants to furnish 
maintenance therapy; and change the split percentage payment approach 
under the HH PPS. This proposed rule would also solicit comments on the 
wage index used to adjust home health payments and suggestions for 
possible updates and improvements to the geographic adjustment of home 
health payments. In addition, it proposes public reporting of certain 
performance data under the Home Health Value-Based Purchasing (HHVBP) 
Model. We are proposing to publicly report the Total Performance Score 
(TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 
2020) Annual TPS and Payment Adjustment Report for each home health 
agency in the nine Model states that qualified for a payment adjustment 
for CY 2020. It also proposes changes with respect to the Home Health 
Quality Reporting Program to remove one measure, to adopt two new 
measures, modify an existing measure, adopt new standardized patient 
assessment data beginning with the CY 2022 HH QRP, codify the HH QRP 
policies in a new section, and to remove question 10 from all the HH 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
surveys. Lastly, it would set forth routine updates to the home 
infusion therapy payment rates for CY 2020 and propose payment 
provisions for home infusion therapy services for CY 2021 and 
subsequent years.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on September 9, 
2019.

ADDRESSES: In commenting, please refer to file code CMS-1711-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to 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-P, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1711-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Kelly Vontran, (410) 786-0332, for 
Home Health Prospective Payment System (HH PPS) or home infusion 
payment.
    For general information about the Home Health Prospective Payment 
System (HH PPS), send your inquiry via email to: 
[email protected].
    For general information about home infusion payment, send your 
inquiry via email to: [email protected].
    For information about the Home Health Value-Based Purchasing 
(HHVBP) Model, send your inquiry via email to: 
[email protected].
    For information about the Home Health Quality Reporting Program (HH 
QRP), send your inquiry via email to [email protected].

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: 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. Proposed Provisions for Payment Under the Home Health 
Prospective Payment System (HH PPS)
    A. Implementation of the Patient-Driven Groupings Model (PDGM) 
for CY 2020
    B. Implementation of a 30-Day Unit of Payment for CY 2020
    C. Proposed CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes 
of Care Spanning Implementation of the PDGM
    D. Proposed CY 2020 PDGM Case-Mix Weights and Low-Utilization 
Payment Adjustment (LUPA) Thresholds
    E. Proposed CY 2020 Home Health Payment Rate Updates
    F. Proposed Payments for High-Cost Outliers Under the HH PPS
    G. Proposed Changes to the Split-Percentage Payment Approach for 
HHAs in CY 2020 and Subsequent Years
    H. Proposed Change To Allow Therapist Assistants To Perform 
Maintenance Therapy
    I. Proposed Changes to the Home Health Plan of Care Regulations 
at Sec.  409.43
IV. Proposed Provisions of the Home Health Value-Based Purchasing 
(HHVBP) Model
    A. Background
    B. Public Reporting of Total Performance Scores and Percentile 
Rankings Under the HHVBP Model
    C. CMS Proposal To Remove Improvement in Pain Interfering With 
Activity Measure (NQF #0177)
V. Proposed Updates to the Home Health Quality Reporting Program (HH 
QRP)
    A. Background and Statutory Authority

[[Page 34599]]

    B. General Considerations Used for the Selection of Quality 
Measures for the HH QRP
    C. Quality Measures Currently Adopted for the CY 2021 HH QRP
    D. Proposed Removal of HH QRP Measures Beginning With the CY 
2022 HH QRP
    E. Proposed New and Modified HH QRP Quality Measures Beginning 
With the CY 2022 HH QRP
    F. HH QRP Quality Measures, Measure Concepts, and Standardized 
Patient Assessment Data Elements Under Consideration for Future 
Years: Request for Information
    G. Proposed Standardized Patient Assessment Data Reporting 
Beginning with the CY 2022 HH QRP
    H. Proposed Standardized Patient Assessment Data by Category
    I. Form, Manner, and Timing of Data Submission Under the HH QRP
    J. Proposed Codification of the Home Health Quality Reporting 
Program Requirements
    K. Home Health Care Consumer Assessment of Healthcare Providers 
and Systems (CAHPS[supreg]) Survey (HHCAHPS)
VI. Medicare Coverage of Home Infusion Therapy Services
    A. Background and Overview
    B. CY 2020 Temporary Transitional Payment Rates for Home 
Infusion Therapy Services
    C. Proposed Home Infusion Therapy Services for CY 2021 and 
Subsequent Years
    D. Proposed Payment Categories and Amounts for Home Infusion 
Therapy Services for CY 2021
    E. Required Payment Adjustments for CY 2021 Home Infusion 
Therapy Services
    F. Other Optional Payment Adjustments/Prior Authorization for CY 
2021 Home Infusion Therapy Services
    G. Billing Procedures for CY 2021 Home Infusion Therapy Services
VII. Collection of Information Requirements
VIII. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    D. Detailed Economic Analysis
    E. Alternatives Considered
    F. Accounting Statement and Tables
    G. Regulatory Reform Analysis Under E.O. 13771
    H. Conclusion
    Regulation Text

I. Executive Summary

A. Purpose

1. Home Health Prospective Payment System (HH PPS)
    This proposed rule would update the payment rates for home health 
agencies (HHAs) for calendar year (CY) 2020, as required under section 
1895(b) of the Social Security Act (the Act). This proposed rule would 
also update the case-mix weights under section 1895(b)(4)(A)(i) and 
(b)(4)(B) of the Act for 30-day periods of care beginning on or after 
January 1, 2020. This rule would also implement the PDGM, a revised 
case-mix adjustment methodology that was finalized in the CY 2019 HH 
PPS final rule (83 FR 56406), which would also implement the removal of 
therapy thresholds for payment as required by section 1895(b)(4)(B)(ii) 
of the Act, as amended by section 51001(a)(3) of the BBA of 2018, and 
changes the unit of home health payment from 60-day episodes of care to 
30-day periods of care, as required by section 1895(b)(2)(B) of the 
Act, as amended by 51001(a)(1) of the BBA of 2018. This proposed rule 
also proposes to allow therapist assistants to furnish maintenance 
therapy; proposes changes to the payment regulations pertaining to the 
content of the home health plan of care; proposes technical regulations 
text changes clarifying the split-percentage payment approach for 
newly-enrolled HHAs in CY 2020 and proposes a change in the split 
percentage payment approach for existing HHAs in CY 2020 and subsequent 
years.
2. HHVBP
    This rule proposes public reporting of the TPS and the TPS 
Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and 
Payment Adjustment Report for each HHA that qualifies for a payment 
adjustment under the HHVBP Model for CY 2020.
3. HH QRP
    This rule purposes changes to the Home Health Quality Reporting 
Program (HH QRP) requirements under the authority of section 
1895(b)(3)(B)(v) of the Act.
4. Home Infusion Therapy
    This proposed rule would update the CY 2020 payment rates for the 
temporary transitional payment for home infusion therapy services as 
required by section 1834(u)(7) of the Act, as added by section 50401 of 
the BBA of 2018. This rule also proposes payment provisions for home 
infusion therapy services for CY 2021 and subsequent years in 
accordance with section 1834(u)(1) of the Act, as added by section 5012 
of the 21st Century Cures Act (Pub. L. 114-255).

B. Summary of the Major Provisions

1. Home Health Prospective Payment System (HH PPS)
    Section III.A. of this rule, sets forth planned implementation of 
the Patient-Driven Groupings Model (PDGM) as required by section 51001 
of the BBA of 2018 (Pub. L. 115-123). The PDGM is an alternate case-mix 
adjustment methodology to adjust payments for home health periods of 
care beginning on and after January 1, 2020. The PDGM relies more 
heavily on clinical characteristics and other patient information to 
place patients into meaningful payment categories and eliminates the 
use of therapy service thresholds, as required by section 1895(b)(4)(B) 
of the Act, as amended by section 51001(a)(3) of the BBA of 2018. 
Section III.B. of this rule also implements a change in the unit of 
payment from a 60-day episode of care to a 30-day period of care as 
required by section 1895(b)(2) of the Act, as amended by section 
51001(a)(1) of the BBA of 2018.
    Section III.C. of this proposed rule describes the CY 2020 case-mix 
weights for those 60-day episodes that span the implementation date of 
the PDGM and section III.D. of this proposed rule proposes the CY 2020 
PDGM case-mix weights and LUPA thresholds for 30-day periods of care. 
In section III.E. of this proposed rule, we propose to update the home 
health wage index and to update the national, standardized 60-day 
episode of care and 30-day period of care payment amounts, the national 
per-visit payment amounts as well and the non-routine supplies (NRS) 
conversion factor for 60-day episodes of care that begin in 2019 and 
span the 2020 implementation date of the PDGM. The home health payment 
update percentage for CY 2020 will be 1.5 percent, as required by 
section 53110 of the BBA of 2018. We also solicit comments on concerns 
stakeholders may have regarding the wage index used to adjust home 
health payments and suggestions for possible updates and improvements 
to the geographic adjustment of home health payments. Section III.F. of 
this proposed rule proposes a change to the fixed-dollar loss ratio to 
0.63 for CY 2020 under the PDGM in order to ensure that outlier 
payments as a percentage of total payments is closer to, but no more 
than, 2.5 percent, as required by section 1895(b)(5)(A) of the Act. 
Section III.G. of this proposed rule, proposes a technical regulations 
text correction at Sec.  484.205 regarding split-percentage payments 
for newly-enrolled HHAs in CY 2020; proposes changes to reduce the 
split-percentage payment amounts for existing HHAs in CY 2020; and 
proposes to eliminate split-percentage payments entirely beginning in 
CY 2021. In section III.H. of this proposed rule, we propose to allow 
physical therapist assistants to furnish maintenance therapy under the 
Medicare home health benefit, and section III.I. of this proposed 
proposes a change in the payment regulations at

[[Page 34600]]

Sec.  409.43 related to home health plan of care requirements for 
payment.
2. HHVBP
    In section IV. of this proposed rule, we are proposing to publicly 
report performance data for Performance Year (PY) 5 of the HHVBP Model. 
Specifically, we are proposing to publicly report the TPS and the TPS 
Percentile Ranking from the PY 5 (CY 2020) Annual TPS and Payment 
Adjustment Report for each HHA in the nine Model states that qualified 
for a payment adjustment for CY 2020.
3. HH QRP
    In section V. of this rule, we propose updates to the Home Health 
Quality Reporting Program (HH QRP) including: The removal of one 
quality measure, the adoption of two new quality measures, the 
modification of an existing measure, and the reporting of standardized 
patient assessment data described under section 1899B(b)(1)(B) of the 
Act. In section V.J. of this rule, we are proposing to codify HH QRP 
policies in a newly created section of the regulations. Finally, in 
section V.K. of the rule we propose removing question 10 from all 
HHCAHPS Surveys (both mail surveys and telephone surveys).
4. Home Infusion Therapy
    In section VI.A. of this proposed rule, we discuss general 
background of home infusion therapy services and how that will relate 
to the implementation of the new home infusion benefit in CY 2021. 
Section VI.B. of this proposed rule updates the CY 2020 home infusion 
therapy services temporary transitional payment rates, in accordance 
with section 1834(u)(7) of the Act. In section VI.C. of this proposed 
rule, we are proposing to add a new subpart P under the regulations at 
42 CFR part 414 to incorporate conforming regulations text regarding 
conditions for payment for home infusion therapy services for CY 2021 
and subsequent years. Proposed subpart P would include beneficiary 
qualifications and plan of care requirements in accordance with section 
1861(iii) of the Act. In section VI.D. of this proposed rule, we 
propose payment provisions for the full implementation of the home 
infusion therapy benefit in CY 2021 upon expiration of the home 
infusion therapy services temporary transitional payments in CY 2020. 
The home infusion therapy services payment system is to be implemented 
starting in CY 2021, as mandated by section 5012 of the 21st Century 
Cures Act. The provisions in this section include proposed payment 
categories, amounts, and required and optional payment adjustments. In 
section VI.E. of this proposed rule, we propose to use the Geographic 
Adjustment Factor (GAF) to wage adjust the home infusion therapy 
payment as required by section 1834(u)(1)(B)(i) of the Act. In this 
section VI.F. of this proposed rule, we offer a discussion on several 
topics for home infusion therapy services for CY 2021 such as: Optional 
payment adjustments, prior authorization, and high-cost outliers. 
Lastly, in section VI.H. of this proposed rule, we discuss billing 
procedures for CY 2021 home infusion therapy services.

C. Summary of Costs, Transfers, and Benefits

BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP18JY19.034

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 Social Security Act (the Act), 
entitled ``Prospective Payment For Home Health Services.'' Section 
1895(b)(1) of the Act requires the Secretary to establish a HH PPS for 
all costs of home health services paid under Medicare. Section 
1895(b)(2) of the Act required that, in defining a prospective payment 
amount, the Secretary will consider an appropriate unit of service and 
the number, type, and duration of visits provided within that unit, 
potential changes in the mix of services provided within that unit and 
their cost, and a general system design that provides for continued 
access to quality services.
    Section 1895(b)(3)(A) of the Act required the following: (1) The 
computation of a standard prospective payment amount that includes all 
costs for HH services covered and paid for on a reasonable cost basis, 
and that such amounts be initially based on the most recent audited 
cost report data available to the Secretary (as of the effective date 
of the 2000 final rule), and (2) the standardized prospective payment 
amount be adjusted to account for the effects of case-mix and wage 
levels among HHAs.
    Section 1895(b)(3)(B) of the Act requires the standard prospective 
payment amounts be annually updated by the home health applicable 
percentage increase. Section 1895(b)(4) of the Act governs the payment 
computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act 
require the standard prospective payment amount to be adjusted for 
case-mix and geographic differences in wage levels. Section 
1895(b)(4)(B) of the Act requires

[[Page 34602]]

the establishment of an appropriate case-mix change adjustment factor 
for significant variation in costs among different units of services.
    Similarly, section 1895(b)(4)(C) of the Act requires the 
establishment of area wage adjustment factors that reflect the relative 
level of wages, and wage-related costs applicable to home health 
services furnished in a geographic area compared to the applicable 
national average level. Under section 1895(b)(4)(C) of the Act, the 
wage-adjustment factors used by the Secretary may be the factors used 
under section 1886(d)(3)(E) of the Act. Section 1895(b)(5) of the Act 
gives the Secretary the option to make additions or adjustments to the 
payment amount otherwise paid in the case of outliers due to unusual 
variations in the type or amount of medically necessary care. Section 
3131(b)(2) of the Affordable Care Act revised section 1895(b)(5) of the 
Act so that total outlier payments in a given year would not exceed 2.5 
percent of total payments projected or estimated. The provision also 
made permanent a 10 percent agency-level outlier payment cap.
    In accordance with the statute, as amended by the BBA, we published 
a final rule in the July 3, 2000 Federal Register (65 FR 41128) to 
implement the HH PPS legislation. The July 2000 final rule established 
requirements for the new HH PPS for home health services as required by 
section 4603 of the BBA, as subsequently amended by section 5101 of the 
Omnibus Consolidated and Emergency Supplemental Appropriations Act for 
Fiscal Year 1999 (OCESAA), (Pub. L. 105-277, enacted October 21, 1998); 
and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP 
Balanced Budget Refinement Act of 1999, (BBRA) (Pub. L. 106-113, 
enacted November 29, 1999). The requirements include the implementation 
of a HH PPS for home health services, consolidated billing 
requirements, and a number of other related changes. The HH PPS 
described in that rule replaced the retrospective reasonable cost-based 
system that was used by Medicare for the payment of home health 
services under Part A and Part B. For a complete and full description 
of the HH PPS as required by the BBA, see the July 2000 HH PPS final 
rule (65 FR 41128 through 41214).
    Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) 
to the Act, requiring HHAs to submit data for purposes of measuring 
health care quality, and linking the quality data submission to the 
annual applicable payment percentage increase. This data submission 
requirement is applicable for CY 2007 and each subsequent year. If an 
HHA does not submit quality data, the home health market basket 
percentage increase is reduced by 2 percentage points. In the November 
9, 2006 Federal Register (71 FR 65935), we published a final rule to 
implement the pay-for-reporting requirement of the DRA, which was 
codified at Sec.  484.225(h) and (i) in accordance with the statute. 
The pay-for-reporting requirement was implemented on January 1, 2007.
    The Affordable Care Act made additional changes to the HH PPS. One 
of the changes in section 3131 of the Affordable Care Act is the 
amendment to section 421(a) of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, 
enacted on December 8, 2003) as amended by section 5201(b) of the DRA. 
Section 421(a) of the MMA, as amended by section 3131 of the Affordable 
Care Act, requires that the Secretary increase, by 3 percent, the 
payment amount otherwise made under section 1895 of the Act, for HH 
services furnished in a rural area (as defined in section 1886(d)(2)(D) 
of the Act) with respect to episodes and visits ending on or after 
April 1, 2010, and before January 1, 2016.
    Section 210 of the Medicare Access and CHIP Reauthorization Act of 
2015 (Pub. L. 114-10) (MACRA) amended section 421(a) of the MMA to 
extend the 3 percent rural add-on payment for home health services 
provided in a rural area (as defined in section 1886(d)(2)(D) of the 
Act) through January 1, 2018. In addition, section 411(d) of MACRA 
amended section 1895(b)(3)(B) of the Act such that CY 2018 home health 
payments be updated by a 1 percent market basket increase. Section 
50208(a)(1) of the BBA of 2018 again extended the 3 percent rural add-
on through the end of 2018. In addition, this section of the BBA of 
2018 made some important changes to the rural add-on for CYs 2019 
through 2022, to be discussed later in this proposed rule.

B. Current System for Payment of Home Health Services

    Generally, Medicare currently makes payment under the HH PPS on the 
basis of a national, standardized 60-day episode payment rate that is 
adjusted for the applicable case-mix and wage index. The national, 
standardized 60-day episode rate includes the six home health 
disciplines (skilled nursing, home health aide, physical therapy, 
speech-language pathology, occupational therapy, and medical social 
services). Payment for non-routine supplies (NRS) is not part of the 
national, standardized 60-day episode rate, but is computed by 
multiplying the relative weight for a particular NRS severity level by 
the NRS conversion factor. Payment for durable medical equipment 
covered under the HH benefit is made outside the HH PPS payment system. 
To adjust for case-mix, the HH PPS uses a 153-category case-mix 
classification system to assign patients to a home health resource 
group (HHRG). The clinical severity level, functional severity level, 
and service utilization are computed from responses to selected data 
elements in the Outcome and Assessment Information Set (OASIS) 
assessment instrument and are used to place the patient in a particular 
HHRG. Each HHRG has an associated case-mix weight which is used in 
calculating the payment for an episode. Therapy service use is measured 
by the number of therapy visits provided during the episode and can be 
categorized into nine visit level categories (or thresholds): 0 to 5; 
6; 7 to 9; 10; 11 to 13; 14 to 15; 16 to 17; 18 to 19; and 20 or more 
visits.
    For episodes with four or fewer visits, Medicare pays national per-
visit rates based on the discipline(s) providing the services. An 
episode consisting of four or fewer visits within a 60-day period 
receives what is referred to as a low-utilization payment adjustment 
(LUPA). Medicare also adjusts the national standardized 60-day episode 
payment rate for certain intervening events that are subject to a 
partial episode payment adjustment (PEP adjustment). For certain cases 
that exceed a specific cost threshold, an outlier adjustment may also 
be available.

C. New Home Health Prospective Payment System for CY 2020 and 
Subsequent Years

    In the CY 2019 HH PPS final rule (83 FR 56446), we finalized a new 
patient case-mix adjustment methodology, the Patient-Driven Groupings 
Model (PDGM), to shift the focus from volume of services to a more 
patient-driven model that relies on patient characteristics. For home 
health periods of care beginning on or after January 1, 2020, the PDGM 
uses timing, admission source, principal and other diagnoses, and 
functional impairment to case-mix adjust payments. The PDGM results in 
432 unique case-mix groups. Low-utilization payment adjustments (LUPAs) 
will vary; instead of the current four visit threshold, each of the 432 
case-mix groups has its own threshold to determine if a 30-day period 
of care

[[Page 34603]]

would receive a LUPA. Additionally, non-routine supplies (NRS) are 
included in the base payment rate for the PDGM instead of being 
separately adjusted as in the current HH PPS. Also in the CY 2019 HH 
PPS final rule, we finalized a change in the unit of home health 
payment from 60-day episodes of care to 30-day periods of care, and 
eliminated the use of therapy thresholds used to adjust payments in 
accordance with section 51001 of the BBA of 2018. Thirty-day periods of 
care will be adjusted for outliers and partial episodes as applicable. 
For LUPAs under the PDGM, we finalized that the LUPA threshold would 
vary for a 30-day period under the PDGM using 10th percentile value of 
visits to create a payment group specific LUPA threshold with a minimum 
threshold of at least 2 visits for each payment group. Finally, for CYs 
2020 through 2022, home health services provided to beneficiaries 
residing in rural counties will be increased based on rural county 
classification (high utilization; low population density; or all 
others) in accordance with section 50208 of the BBA of 2018.

D. Analysis of FY 2017 HHA Cost Report Data for 60-Day Episodes and 30-
Day Periods

    In the CY 2019 HH PPS proposed rule (83 FR 32348), we provided a 
summary of analysis on fiscal year (FY) 2016 HHA cost report data and 
how such data, if used, would impact our estimate of the percentage 
difference between Medicare payments and HHA costs. We stated in the CY 
2019 HH PPS final rule (83 FR 56414) that we will continue to monitor 
the impacts due to policy changes and will provide the industry with 
periodic updates on our analysis in rulemaking and/or announcements on 
the HHA Center web page.
    In this year's proposed rule, we examined FY 2017 HHA cost reports 
as this is the most recent and complete cost report data at the time of 
rulemaking. We examined the estimated 60-day episode costs using FY 
2017 cost reports and CY 2017 home health claims and the estimated 
costs for 60-day episodes by discipline and the total estimated cost 
for a 60-day episode for 2017 is shown in Table 2.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP18JY19.035

    To estimate the costs for CY 2020, we updated the estimated 60-day 
episode costs with NRS by the home health market basket update, minus 
the multifactor productivity adjustment for CYs 2018 and 2019. For CY 
2020, the BBA of 2018 requires a market basket update of 1.5 percent. 
The estimated costs for 60-day episodes by discipline and the total 
estimated cost for a 60-day episode for CY 2020 is shown in Table 3.
[GRAPHIC] [TIFF OMITTED] TP18JY19.036

    The CY 2019 60-day episode payment is $3,154.27. Updating this 
payment amount by the CY 2020 home health market basket of 1.5 percent 
results in an estimated CY 2020 60-day episode payment of $3,201.58, 
approximately 18

[[Page 34604]]

percent more than the estimated CY 2020 60-day episode cost of 
$2,713.30. Next, we also looked at the estimated costs for 30-day 
periods of care in 2017 using FY 2017 cost reports and CY 2017 claims. 
Thirty-day periods were simulated from 60-day episodes and we excluded 
low-utilization payment adjusted episodes and partial-episode-payment 
adjusted episodes. The 30-day periods were linked to OASIS assessments 
and covered the 60-day episodes ending in CY 2017. The estimated costs 
for 30-day periods by discipline and the total estimated cost for a 30-
day period for 2017 is shown in Table 4.
[GRAPHIC] [TIFF OMITTED] TP18JY19.037

    To estimate the costs for CY 2020, we updated the estimated 30-day 
period costs with NRS by the home health market basket update, minus 
the multifactor productivity adjustment for CYs 2018 and 2019. For CY 
2020, the BBA of 2018 requires a market basket update of 1.5 percent. 
The estimated costs for 30-day periods by discipline and the total 
estimated cost for a 30-day period for CY 2020 is shown in Table 5.
[GRAPHIC] [TIFF OMITTED] TP18JY19.038

BILLING CODE 4120-01-C
    The estimated, budget-neutral 30-day payment for CY 2020 is 
$1,754.37 as described in section III.E. of this proposed rule. 
Updating this amount by the CY 2020 home health market basket of 1.5 
percent and the wage index budget neutrality factor results in an 
estimated CY 2020 30-day payment amount of $ $1,791.73, approximately 
14 percent more than the estimated CY 2020 30-day period cost of 
$1,577.52. After implementation of the 30-day unit of payment and the 
PDGM in CY 2020, we will continue to analyze the costs by discipline as 
well as the overall cost for a 30-day period of care to determine the 
effects, if any, of these changes.

III. Proposed Provisions for Payment Under the Home Health Prospective 
Payment System (HH PPS)

A. Implementation of the Patient-Driven Groupings Model (PDGM) for CY 
2020

1. Background and Legislative History
    In the CY 2019 HH PPS final rule (83 FR 56406), we finalized 
provisions to implement changes mandated by the BBA of 2018 for CY 
2020, which included a change in the unit of payment from a 60-day 
episode of care to a 30-day period of care, as required by section 
51001(a)(1)(B), and the elimination of therapy thresholds used for 
adjusting home health payment, as required by section 51001(a)(3)(B). 
In order to eliminate the use of therapy thresholds in adjusting 
payment under the HH PPS, we finalized an alternative case mix-
adjustment methodology, known as the Patient-Driven Groupings Model 
(PDGM), to be implemented for home health periods of care beginning on 
or after January 1, 2020.

[[Page 34605]]

    In regard to the 30-day unit of payment, section 51001(a)(1) of the 
BBA of 2018 amended section 1895(b)(2) of the Act by adding a new 
subparagraph (B) to require the Secretary to apply a 30-day unit of 
service, effective January 1, 2020. Section 51001(a)(2)(A) of the BBA 
of 2018 added a new subclause (iv) under section 1895(b)(3)(A) of the 
Act, requiring the Secretary to calculate a standard prospective 
payment amount (or amounts) for 30-day units of service furnished that 
start and end during the 12-month period beginning January 1, 2020 in a 
budget neutral manner such that estimated aggregate expenditures under 
the HH PPS during CY 2020 are equal to the estimated aggregate 
expenditures that otherwise would have been made under the HH PPS 
during CY 2020 in the absence of the change to a 30-day unit of 
service. Section 1895(b)(3)(A)(iv) of the Act requires that the 
calculation of the standard prospective payment amount (or amounts) for 
CY 2020 be made before the application of the annual update to the 
standard prospective payment amount as required by section 
1895(b)(3)(B) of the Act.
    Section 1895(b)(3)(A)(iv) of the Act additionally requires that in 
calculating the standard prospective payment amount (or amounts), the 
Secretary must make assumptions about behavior changes that could occur 
as a result of the implementation of the 30-day unit of service under 
section 1895(b)(2)(B) of the Act and case-mix adjustment factors 
established under section 1895(b)(4)(B) of the Act. Section 
1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide 
a description of the behavior assumptions made in notice and comment 
rulemaking. CMS described these behavior assumptions in the CY 2019 HH 
PPS proposed rule (83 FR 32389) and these assumptions are further 
described in section III.F. of this proposed rule.
    Section 51001(a)(2)(B) of the BBA of 2018 also added a new 
subparagraph (D) to section 1895(b)(3) of the Act. Section 
1895(b)(3)(D)(i) of the Act requires the Secretary to annually 
determine the impact of differences between assumed behavior changes as 
described in section 1895(b)(3)(A)(iv) of the Act, and actual behavior 
changes on estimated aggregate expenditures under the HH PPS with 
respect to years beginning with 2020 and ending with 2026. Section 
1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a 
manner determined appropriate, through notice and comment rulemaking, 
to provide for one or more permanent increases or decreases to the 
standard prospective payment amount (or amounts) for applicable years, 
on a prospective basis, to offset for such increases or decreases in 
estimated aggregate expenditures, as determined under section 
1895(b)(3)(D)(i) of the Act. Additionally, 1895(b)(3)(D)(iii) of the 
Act requires the Secretary, at a time and in a manner determined 
appropriate, through notice and comment rulemaking, to provide for one 
or more temporary increases or decreases, based on retrospective 
behavior, to the payment amount for a unit of home health services for 
applicable years, on a prospective basis, to offset for such increases 
or decreases in estimated aggregate expenditures, as determined under 
section 1895(b)(3)(D)(i) of the Act. Such a temporary increase or 
decrease shall apply only with respect to the year for which such 
temporary increase or decrease is made, and the Secretary shall not 
take into account such a temporary increase or decrease in computing 
the payment amount for a unit of home health services for a subsequent 
year. And finally, section 51001(a)(3) of the BBA of 2018 amends 
section 1895(b)(4)(B) of the Act by adding a new clause (ii) to require 
the Secretary to eliminate the use of therapy thresholds in the case-
mix system for CY 2020 and subsequent years.
2. Overview and CY 2020 Implementation of the PDGM
    To better align payment with patient care needs and better ensure 
that clinically complex and ill beneficiaries have adequate access to 
home health care, in the CY 2019 HH PPS final rule (83 FR 56406), we 
finalized case-mix methodology refinements through the PDGM for home 
health periods of care beginning on or after January 1, 2020. We 
believe that the PDGM case-mix methodology better aligns payment with 
patient care needs and is a patient-centered model that groups periods 
of care in a manner consistent with how clinicians differentiate 
between patients and the primary reason for needing home health care. 
This proposed rule would set forth the requirements for the 
implementation of the PDGM, as well as updates to the PDGM case-mix 
weights and payment rates, which would be effective on January 1, 2020. 
The PDGM and a change to a 30-day unit of payment were finalized in the 
CY 2019 HH PPS final rule (83 FR 56406) and, as such, there are no new 
policy proposals in this proposed rule on the structure of the PDGM or 
the change to a 30-day unit of payment. However, there are proposals 
related to the split-percentage payments upon implementation of the 
PDGM and the 30-day unit of payment in section III.G. of this proposed 
rule.
    The PDGM uses 30-day periods of care rather than 60-day episodes of 
care as the unit of payment, as required by section 51001(a)(1)(B) of 
the BBA of 2018; eliminates the use of the number of therapy visits 
provided to determine payment, as required by section 51001(a)(3)(B) of 
the BBA of 2018; and relies more heavily on clinical characteristics 
and other patient information (for example, diagnosis, functional 
level, comorbid conditions, admission source) to place patients into 
clinically meaningful payment categories. A national, standardized 30-
day period payment amount, as described in section III.F. of this 
proposed rule, would be adjusted by the case-mix weights as determined 
by the variables in the PDGM. Payment for non-routine supplies (NRS) is 
now included in the national, standardized 30-day payment amount. In 
total, there are 432 different payment groups in the PDGM. These 432 
Home Health Resource Groups (HHRGs) represent the different payment 
groups based on five main case-mix variables under the PDGM, as shown 
in Diagram B1, and subsequently described in more detail throughout 
this section.
    Under this new case-mix methodology, case-mix weights are generated 
for each of the different PDGM payment groups by regressing resource 
use for each of the five categories listed in this section of this 
proposed rule (timing, admission source, clinical grouping, functional 
impairment level, and comorbidity adjustment) using a fixed effects 
model. Annually recalibrating the PDGM case-mix weights ensures that 
the case-mix weights reflect the most recent utilization data at the 
time of annual rulemaking. The proposed CY 2020 PDGM case-mix weights 
are listed in section III.D. of this proposed rule.
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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 recertifications continue on a 60-day 
basis and the comprehensive assessment will still be completed within 5 
days of the start of care date and completed no less frequently than 
during the last 5 days of every 60 days beginning with the start of 
care date, as currently required by Sec.  484.55, ``Condition of 
participation: Comprehensive assessment of patients.''
b. Admission Source
    Each 30-day period of care will also be classified into one of two 
admission source categories--community or institutional--depending on 
what healthcare setting was utilized in the 14 days prior to home 
health. Thirty-day periods of care for beneficiaries with any inpatient 
acute care hospitalizations, inpatient psychiatric facility (IPF) 
stays, skilled nursing facility (SNF) stays, inpatient rehabilitation 
facility (IRF) stays, or long-term care hospital (LTCH) stays within 
14-days prior to a home health admission will be designated as 
institutional admissions.

[[Page 34607]]

    The institutional admission source category will also include 
patients that had an acute care hospital stay during a previous 30-day 
period of care and within 14 days prior to the subsequent, contiguous 
30-day period of care and for which the patient was not discharged from 
home health and readmitted (that is, the ``admission date'' and ``from 
date'' for the subsequent 30-day period of care do not match), as we 
acknowledge that HHAs have discretion as to whether they discharge the 
patient due to a hospitalization and then readmit the patient after 
hospital discharge. However, we will not categorize post-acute care 
stays, meaning SNF, IRF, LTCH, or IPF stays, that occur during a 
previous 30-day period of care and within 14 days of a subsequent, 
contiguous 30-day period of care as institutional (that is, the 
``admission date'' and ``from date'' for the subsequent 30-day period 
of care do not match), as we would expect the HHA to discharge the 
patient if the patient required post-acute care in a different setting, 
or inpatient psychiatric care, and then readmit the patient, if 
necessary, after discharge from such setting. All other 30-day periods 
of care would be designated as community admissions.
    Information from the Medicare claims processing system will 
determine the appropriate admission source for final claim payment. The 
OASIS assessment will not be utilized in evaluating for admission 
source information. We believe that obtaining this information from the 
Medicare claims processing system, rather than as reported on the 
OASIS, is a more accurate way to determine admission source information 
as HHAs may be unaware of an acute or post-acute care stay prior to 
home health admission. While HHAs can report an occurrence code on 
submitted claims to indicate the admission source, obtaining this 
information from the Medicare claims processing system allows CMS the 
opportunity and flexibility to verify the source of the admission and 
correct any improper payments as deemed appropriate. When the Medicare 
claims processing system receives a Medicare home health claim, the 
systems will check for the presence of a Medicare acute or post-acute 
care claim for an institutional stay. If such an institutional claim is 
found, and the institutional claim occurred within 14 days of the home 
health admission, our systems will trigger an automatic adjustment to 
the corresponding HH claim to the appropriate institutional category. 
Similarly, when the Medicare claims processing system receives a 
Medicare acute or post-acute care claim for an institutional stay, the 
systems will check for the presence of a HH claim with a community 
admission source payment group. If such HH claim is found, and the 
institutional stay occurred within 14 days prior to the home health 
admission, our systems will trigger an automatic adjustment of the HH 
claim to the appropriate institutional category. This process may occur 
any time within the 12-month timely filing period for the acute or 
post-acute claim.
    However, situations in which the HHA has information about the 
acute or post-acute care stay, HHAs will be allowed to manually 
indicate on Medicare home health claims that an institutional admission 
source had occurred prior to the processing of an acute/post-acute 
Medicare claim, in order to receive higher payment associated with the 
institutional admission source. This will be done through the reporting 
of one of two admission source occurrence codes on home health claims--
     Occurrence Code 61: To indicate an acute care hospital 
discharge within 14 days prior to the ``From Date'' of any home health 
claim; or
     Occurrence Code 62: To indicate a SNF, IRF, LTCH, or IPF 
discharge with 14 days prior to the ``Admission Date'' of the first 
home health claim.
    If the HHA does not include an occurrence code on the HH claim to 
indicate that that the home health patient had a previous acute or 
post-acute care stay, the period of care will be categorized as a 
community admission source. However, if later a Medicare acute or post-
acute care claim for an institutional stay occurring within 14 days of 
the home health admission is submitted within the timely filing 
deadline and processed by the Medicare systems, the HH claim will be 
automatically adjusted as an institutional admission and the 
appropriate payment modifications will be made. For purposes of a 
Request for Anticipated Payment (RAP), only the final claim will be 
adjusted to reflect the admission source. More information regarding 
the admission source reporting requirements for RAP and claims 
submission can be found in Change Request 11081, ``Home Health (HH) 
Patient-Drive Groupings Model (PDGM)-Split Implementation''.\1\ 
Accordingly, the Medicare Claims Processing Manual, chapter 10,\2\ will 
be updated to reflect all of the claims processing changes associated 
with implementation of the PDGM.
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    \1\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4244CP.pdf.
    \2\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c10.pdf.
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c. Clinical Groupings
    Each 30-day period of care will be grouped into one of 12 clinical 
groups which describe the primary reason for which patients are 
receiving home health services under the Medicare home health benefit. 
The clinical grouping is based on the principal diagnosis reported on 
home health claims. The 12 clinical groups are listed and described in 
Table 6.

[[Page 34608]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.040

    It is possible for the principal diagnosis to change between the 
first and second 30-day period of care and the claim for the second 30-
day period of care would reflect the new principal diagnosis. HHAs 
would not change the claim for the first 30-day period. However, a 
change in the principal diagnosis does not necessarily mean that an 
``other follow-up'' OASIS assessment (RFA 05) would need to be 
completed just to make the diagnoses match. However, if a patient 
experienced a significant change in condition before the start of a 
subsequent, contiguous 30-day period of care, for example due to a 
fall, in accordance with Sec.  484.55(d)(1)(ii) the HHA is required to 
update the comprehensive assessment. The Home Health Agency 
Interpretive Guidelines for Sec.  484.55(d), state that a marked 
improvement or worsening of a patient's condition, which changes, and 
was not anticipated in, the patient's plan of care would be considered 
a ``major decline or improvement in the patient's health status'' that 
would warrant update and revision of the comprehensive assessment.\3\ 
Additionally, in accordance with Sec.  484.60, the total plan of care 
must be reviewed and revised by the physician who is responsible for 
the home health plan of care and the HHA as frequently as the patient's 
condition or needs require, but no less frequently than once every 60 
days, beginning with the start of care date.
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    \3\ State Operations Manual (SOM), Appendix B. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-25-HHA.pdf.
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    In the event of a significant change of condition warranting an 
updated comprehensive assessment, an ``other follow-up assessment'' 
(RFA 05) would be submitted before the start of a subsequent, 
contiguous 30-day period, which may reflect a change in the functional 
impairment level and the second 30-day claim would be grouped into its 
appropriate case-mix group accordingly. An ``other follow-up 
assessment'' is a comprehensive assessment conducted due to a major 
decline or improvement in patient's health status occurring at a time 
other than during the last 5 days of the episode. This assessment is 
done to re-evaluate the patient's condition, allowing revision to the 
patient's care plan as appropriate. The ``Outcome and Assessment 
Information Set OASIS-D Guidance Manual,'' effective January 1, 2019, 
provides more detailed guidance for the completion of an ``other 
follow-up'' assessment.\4\ In this respect, two 30-day periods can have 
two different case-mix groups to reflect any changes in patient 
condition. HHAs must be sure to update the assessment completion date 
on the second 30-day claim if a follow-up assessment changes the case-
mix group to ensure the claim can be matched to the follow-up 
assessment. HHAs can submit an adjustment to the original claim 
submitted if an assessment was completed before the start of the second 
30-day period, but was received after the claim was submitted and if 
the assessment items would change the payment grouping.
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    \4\ Outcome and Assessment Information Set OASIS-D Guidance 
Manual Effective January 1, 2019 available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-D-Guidance-Manual-final.pdf.
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    HHAs would determine whether or not to complete a follow-up OASIS 
assessment for a second 30-day period of care depending on the 
individual's clinical circumstances. For example, if the only change 
from the first 30-day period and the second 30-day period is a change 
to the principal diagnosis and there is no change in the patient's 
function, the HHA may determine it is not necessary to complete a 
follow-up assessment. Therefore, the expectation is that HHAs would 
determine whether an ``other follow-up'' assessment is required based 
on the individual's overall condition, the effects of the change on the 
overall home health plan of care, and in accordance with the home 
health CoPs, interpretive guidelines, and the OASIS D Guidance Manual 
instructions, as previously noted.
    For case-mix adjustment purposes, the principal diagnosis reported 
on the home health claim will determine the clinical group for each 30-
day period of care. Currently, billing instructions state that the 
principal diagnosis on the OASIS must also be the principal diagnosis 
on the final claim; however, we will update our billing instructions to 
clarify that there will be no need for the HHA to complete an ``other 
follow-up'' assessment (an RFA 05) just to make the diagnoses match. 
Therefore, for claim ``From'' dates on or after January 1, 2020, the 
ICD-10-CM code and principal diagnosis used for payment grouping will 
be from the claim rather than the OASIS. As a result, the claim and 
OASIS diagnosis codes will no longer be expected to match in all cases. 
Additional claims processing guidance, including the role of the OASIS 
item set will be included

[[Page 34609]]

in the Medicare Claims Processing Manual, chapter 10.\5\
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    \5\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c10.pdf.
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    While these clinical groups represent the primary reason for home 
health services during a 30-day period of care, this does not mean that 
they represent the only reason for home health services. While there 
are clinical groups where the primary reason for home health services 
is for therapy (for example, Musculoskeletal Rehabilitation) and other 
clinical groups where the primary reason for home health services is 
for nursing (for example, Complex Nursing Interventions), home health 
remains a multidisciplinary benefit and payment is bundled to cover all 
necessary home health services identified on the individualized home 
health plan of care. Therefore, regardless of the clinical group 
assignment, HHAs are required, in accordance with the home health CoPs 
at Sec.  484.60(a)(2), to ensure that the individualized home health 
plan of care addresses all care needs, including the disciplines to 
provide such care. Under the PDGM, the clinical group is just one 
variable in the overall case-mix adjustment for a home health period of 
care.
    Finally, we note that we will update the Interactive Grouper Tool 
posted on both the HHA Center web page (https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html) and the dedicated 
PDGM web page (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html). This Interactive Grouper Tool will 
include all of the ICD-10 diagnosis codes used in the PDGM and may be 
used by HHAs to generate PDGM case-mix weights for their patient 
census. This tool is for informational and illustrative purposes only. 
HHAs can also request a Home Health Claims-OASIS Limited Data Set (LDS) 
to accompany the CY 2020 HH PPS proposed and final rules to support 
HHAs in evaluating the effects of the PDGM. The Home Health Claims-
OASIS LDS file can be requested by following the instructions on the 
following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html.
d. Functional Impairment Level
    Under the PDGM, each 30-day period of care will be placed into one 
of three functional impairment levels, low, medium, or high, based on 
responses to certain OASIS functional items as listed in Table 7.
[GRAPHIC] [TIFF OMITTED] TP18JY19.041

    Responses to these OASIS items are grouped together into response 
categories with similar resource use and each response category has 
associated points. A more detailed description as to how these response 
categories were established can be found in the technical report, 
``Overview of the Home Health Groupings Model'' posted on the Home 
Health Center web page.\6\ The sum of these points' results in a 
functional impairment level score used to group 30-day periods of care 
into a functional impairment level with similar resource use. The 
scores associated with the functional impairment levels vary by 
clinical group to account for differences in resource utilization. For 
CY 2020, we used CY 2018 claims data to update the functional points 
and functional impairment levels by clinical group. The updated OASIS 
functional points table and the table of functional impairment levels 
by clinical group for CY 2020 are listed in Tables 4 and 5, 
respectively. For ease of use, instead of listing the response 
categories and the associated points (as shown in Table 28 in the CY 
2019 HH PPS final rule, 83 FR 56478), we have reformatted the OASIS 
Functional Item Response Points (Table 8) to identify how the OASIS 
functional items used for the functional impairment level are assigned 
points under the PDGM. In the CY 2020 HH PPS final rule, we will update 
the points for the OASIS functional item response categories and the 
functional impairment levels by clinical group using the most recent, 
available claims data.
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    \6\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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[GRAPHIC] [TIFF OMITTED] TP18JY19.043


[[Page 34611]]


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BILLING CODE 4120-01-P
    The functional impairment level will remain the same for the first 
and second 30-day periods of care unless there has been a significant 
change in condition which warranted an ``other follow-up'' assessment 
prior to the second 30-day period of care. For each 30-day period of 
care, the Medicare claims processing system will look for the most 
recent OASIS assessment based on the claims ``from date.'' The proposed 
CY 2020 functional points table and the functional impairment level 
thresholds table will be posted on the HHA Center web page at https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html as 
well as on the dedicated PDGM web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html.
e. Comorbidity Adjustment
    Thirty-day periods will receive a comorbidity adjustment category 
based on the presence of certain secondary diagnoses reported on home 
health claims. These diagnoses are based on a home-health specific list 
of clinically and statistically significant secondary diagnosis 
subgroups with similar resource use, meaning the diagnoses have at 
least as high as the median resource use and represent more that 0.1 
percent of 30-day periods of care. Home health 30-day periods of care 
can receive a comorbidity adjustment under the following circumstances:
     Low comorbidity adjustment: There is a reported 
secondary diagnosis on the home health-specific comorbidity subgroup 
list that is associated with higher resource use.
     High comorbidity adjustment: There are two or 
more secondary diagnoses on the home health-specific comorbidity 
subgroup interaction list that are associated with higher resource use 
when both are reported together compared to if they were reported 
separately. That is, the two diagnoses may interact with one another, 
resulting in higher resource use.
     No comorbidity adjustment: A 30-day period of 
care will receive no comorbidity adjustment if no secondary diagnoses 
exist or none meet the criteria for a low or high comorbidity 
adjustment.
    In CY 2020, there are 12 low comorbidity adjustment subgroups as 
identified in Table 10 and 34 high comorbidity adjustment interaction 
subgroups as identified in Table 11. In the CY 2020 HH PPS final rule, 
we will update the comorbidity subgroups and interaction subgroups 
using the most recent, available claims data.
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[[Page 34613]]


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BILLING CODE 4120-01-C
    A 30-day period of care can have a low comorbidity adjustment or a 
high comorbidity adjustment, but not both. A 30-day period of care can 
receive only

[[Page 34614]]

one low comorbidity adjustment regardless of the number of secondary 
diagnoses reported on the home health claim that fell into one of the 
individual comorbidity subgroups or one high comorbidity adjustment 
regardless of the number of comorbidity group interactions, as 
applicable. The low comorbidity adjustment amount will be the same 
across the subgroups and the high comorbidity adjustment will be the 
same across the subgroup interactions. The proposed CY 2020 low 
comorbidity adjustment subgroups and the high comorbidity adjustment 
interaction subgroups including those diagnoses within each of these 
comorbidity adjustments will be posted on the HHA Center webpage at 
https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html as well as on the dedicated PDGM web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html.

B. Implementation of a 30-Day Unit of Payment for CY 2020

    Under section 1895(b)(3)(A)(iv) of the Act, we are required to 
calculate a 30-day payment amount for CY 2020 in a budget-neutral 
manner such that estimated aggregate expenditures under the HH PPS 
during CY 2020 are equal to the estimated aggregate expenditures that 
otherwise would have been made under the HH PPS during CY 2020 in the 
absence of the change to a 30-day unit of payment. Section 
1895(b)(3)(A)(iv) of the Act also requires that in calculating a 30-day 
payment amount in a budget-neutral manner to the Secretary must make 
assumptions about behavior changes that could occur as a result of the 
implementation of the 30-day unit of payment. In addition, in 
calculating a 30-day payment amount in a budget-neutral manner, we must 
take into account behavior changes that could occur as a result of the 
case-mix adjustment factors that are implemented in CY 2020. We are 
also required to calculate a budget-neutral 30-day payment amount 
before the provisions of section 1895(b)(3)(B) of the Act are applied; 
that is, before the home health applicable percentage increase, the 
adjustment if quality data are not reported, and the productivity 
adjustment.
    In the CY 2019 HH PPS proposed rule (83 FR 32389), we proposed 
three assumptions about behavior change that could occur in CY 2020 as 
a result of the implementation of the 30-day unit of payment and the 
implementation of the PDGM case-mix adjustment methodology:
     Clinical Group Coding: A key component of determining 
payment under the PDGM is the 30-day period of care's clinical group 
assignment, which is based on the principal diagnosis code for the 
patient as reported by the HHA on the home health claim. Therefore, we 
proposed to assume that HHAs will change their documentation and coding 
practices and would put the highest paying diagnosis code as the 
principal diagnosis code in order to have a 30-day period of care be 
placed into a higher-paying clinical group. While we do not support or 
condone coding practices or the provision of services solely to 
maximize payment, we often take into account in proposed rules the 
potential behavior effects of policy changes should they be finalized 
and implemented.
     Comorbidity Coding: The PDGM further adjusts payments 
based on patients' secondary diagnoses as reported by the HHA on the 
home health claim. While the OASIS only allows HHAs to designate 1 
primary diagnosis and 5 secondary diagnoses, the home health claim 
allows HHAs to designate 1 principal diagnosis and 24 secondary 
diagnoses. Therefore, we proposed to assume that by taking into account 
additional ICD-10-CM diagnosis codes listed on the home health claim 
(that exceed the 6 allowed on the OASIS), more 30-day periods of care 
will receive a comorbidity adjustment than periods otherwise would have 
received if we only used the OASIS diagnosis codes for payment. The 
comorbidity adjustment in the PDGM can increase payment by up to 20 
percent.
     LUPA Threshold: Rather than being paid the per-visit 
amounts for a 30-day period of care subject to the low-utilization 
payment adjustment (LUPA) under the proposed PDGM, we proposed to 
assume that for one-third of LUPAs that are 1 to 2 visits away from the 
LUPA threshold, HHAs will provide 1 to 2 extra visits to receive a full 
30-day payment.\7\ LUPAs are paid when there are a low number of visits 
furnished in a 30-day period of care. Under the PDGM, the LUPA 
threshold ranges from 2-6 visits depending on the case-mix group 
assignment for a particular period of care (see section III.D. of this 
proposed rule for the LUPA thresholds that correspond to the 432 case-
mix groups under the PDGM).
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    \7\ Current data suggest that what would be about \1/3\ of the 
LUPA episodes with visits near the LUPA threshold move up to become 
non-LUPA episodes. We assume this experience will continue under the 
PDGM, with about \1/3\ of those episodes 1 or 2 visits below the 
thresholds moving up to become non-LUPA episodes.
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    While some commenters supported these three behavior assumptions in 
calculating the budget-neutral 30-day payment amount, many commenters 
disagreed with these assumptions stating that they seem arbitrary, 
overly complex, and that they lack any foundation in evidence-based 
data. Other commenters expressed concern that the behavior assumptions 
would result in too high of a payment reduction and that this could 
create potential access issues. However, in the CY 2019 HH PPS final 
rule, we explained why we believe the three behavior assumptions are 
appropriate based on previously obtained data and precedent for 
adjusting home health prospective payments based on assumed behavior 
changes. We believe that our examples and past experiences described in 
more detail in the CY 2019 HH PPS final rule (83 FR 56456) demonstrate 
that there is a substantive connection between the data and the 
behavior assumptions made. Furthermore, the Medicare Payment Advisory 
Commission (MedPAC) provided comments on the CY 2019 HH PPS proposed 
rule and expressed their support for the behavior assumptions, stating 
that past experience with the home health PPS demonstrates that HHAs 
have changed coding, utilization, and the mix of services provided in 
reaction to new payment incentives. Similarly, in its March, 2019 
Report to Congress, MedPAC stated that behavior assumptions are 
necessary to offset the spending increase expected in 2020 resulting 
from the behavior changes.\8\
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    \8\ MedPAC Report to Congress, Home Care Services, chapter 9, 
March, 2019. https://www.medpac.gov/docs/default-source/reports/mar19_medpac_ch9_sec.pdf?sfvrsn=0.
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    With regards to our assumption that HHAs would code the highest-
paying diagnosis code as primary for the clinical grouping assignment, 
this assumption is based on decades of past experience under the case-
mix system for the HH PPS and other case-mix systems. For example, we 
summarized previous data regarding the substantial increase in payments 
when transitioning from the diagnosis-related groups (DRGs) to the 
Medicare Severity (MS)-DRGs that were not related to actual changes in 
patient severity. Subsequent analysis of inpatient hospital claims data 
supported prospective payment adjustments to account for documentation 
and coding effects was detailed in both the FY 2010 and FY 2011 IPPS 
final rules (74 FR 43770 and 75 FR 50356). We also noted

[[Page 34615]]

that in the first year of the Inpatient Rehabilitation Facility (IRF) 
PPS, there were instances where case-mix increases resulted from 
documentation and coding-induced changes (72 FR 47181). Similarly, we 
cited multiple instances where CMS analyzed the 2008 case-mix 
methodology refinements that resulted in the 153-group HH PPS case-mix 
model to measure change in case-mix, both real and nominal (74 FR 40958 
and 75 FR 43238). We stated that our analysis subsequent to these 
refinements to the current case-mix methodology show an average of 
approximately 2 percent nominal case-mix growth per year (82 FR 35274).
    For the comorbidity coding assumption, we stated that using the 
home health claim for the comorbidity adjustment as opposed to the 
OASIS provides more opportunity to report all comorbid conditions that 
may affect the plan of care. The OASIS item set only allows HHAs to 
report up to five secondary diagnoses, while the home health claim 
(837I institutional claim format-electronic version of the UB-04) 
allows HHAs to report up to 24 secondary diagnoses. Furthermore, ICD-10 
coding guidelines require reporting of all secondary (additional) 
diagnoses that affect the plan of care. Because the comorbidity 
adjustment can increase payment by up to 20 percent, it is a reasonable 
assumption that HHAs would encourage the accurate reporting of 
secondary diagnoses affecting the home health plan of care to more 
accurately identify the conditions affecting resource use.
    Finally, regarding the LUPA threshold assumption, in the CY 2019 HH 
PPS final rule, we referenced data from the FY 2001 HH PPS final rule 
where the episode file showed that approximately 16 percent of episodes 
would have received a LUPA (meaning the 60-day episode had 4 or fewer 
visits). We also stated that currently only about 7 percent of all 60-
day episodes receive a LUPA, meaning that it appears that HHAs changed 
their practice patterns such that, upon implementation of the HH PPS, 
more than half of 60-day episodes that would have been LUPAs received 
the full 60-day episode payment amount. Additionally, while the LUPA 
thresholds vary for each of the 432 case-mix groups, many of these 
groups have a LUPA threshold of two, meaning if the HHA provides more 
than one visit in a 30-day period, it will receive the full 30-day 
payment amount. Given that many groups have only a two-visit threshold, 
we believe it to be a reasonable assumption that some HHAs would 
provide a second visit to receive the full 30-day payment amount. In 
the CY 2019 HH PPS final rule, we finalized the three behavior 
assumptions in calculating a 30-day budget-neutral payment amount given 
the ample evidence-based data supporting such assumptions (83 FR 
56461). In response to comments regarding the impact of the behavior 
assumptions on payments and any potential access issues, in the CY 2019 
HH PPS final rule (83 FR 56461), we stated that we expect that HHAs 
would continue to provide home health services in accordance with the 
home health Conditions of Participation regarding the provision of 
services as established on the individualized home health plan of care. 
We stated that we expect the provision of services to be made to best 
meet the patient's care needs. We also noted that we would monitor any 
changes in utilization patterns, beneficiary impact, and provider 
behavior to see if any refinements to the PDGM would be warranted, or 
if any concerns are identified that may signal the need for appropriate 
program integrity measures.
    In order to calculate the CY 2020 proposed budget neutral 30-day 
payment amounts in this proposed rule, both with and without behavior 
assumptions, we first calculated the total, aggregate amount of 
expenditures that would occur under the current case-mix adjustment 
methodology (as described in section III.D. of this rule) and the 60-
day episode unit of payment using the CY 2019 payment parameters (for 
example, CY 2019 payment rates, case-mix weights, and outlier fixed-
dollar loss ratio). That resulted in a total aggregate expenditures 
target amount of $16.2 billion.\9\ We then calculated what the 30-day 
payment amount would need to be set at in CY 2020, with and without 
behavior assumptions, while taking into account needed changes to the 
outlier fixed-dollar loss ratio under the PDGM in order to pay out no 
more than 2.5 percent of total HH PPS payments as outlier payments 
(refer to section III.F. of this proposed rule) and in order for 
Medicare to pay out $16.2 billion in total expenditures in CY 2020 with 
the application of a 30-day unit of payment under the PDGM. Table 12 
includes the proposed, estimated 30-day budget-neutral payment amount 
for CY 2020 both with and without the behavior assumptions. These 
payment amounts do not include the CY 2020 home health payment update 
of 1.5 percent.
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    \9\ The initial 2018 analytic file included 6,606,602 60-day 
episodes ($18.3 billion in total expenditures). Of these, 962,949 
(14.6 percent) were excluded because they could not be linked to 
OASIS assessments or because of the claims data cleaning process 
reasons listed in section III.F.1 of this proposed rule. We note 
that of the 962,949 claims excluded, 513,998 were excluded because 
they were RAPs without a final claim or they were claims with zero 
payment amounts, resulting in $17.4 billion in total expenditures. 
After removing all 962,949 excluded claims, the 2018 analytic file 
consisted of 5,643,653 60-day episodes ($16.3 billion in total 
expenditures). 60-day episodes of duration longer than 30 days were 
divided into two 30-day periods in order to calculate the 30-day 
payment amounts. As noted in section III.F.1. of this proposed rule, 
there were instances where 30-day periods were excluded from the 
2018 analytic file (for example, we could not match the period to a 
start of care or resumption of care OASIS to determine the 
functional level under the PDGM, the 30-day period did not have any 
skilled visits, or because information necessary to calculate 
payment was missing from claim record). The final 2018 analytic file 
used to calculate budget neutrality consisted of 9,127,459 30-day 
periods ($16.2 billion in total expenditures) drawn from 5,338,939 
60-day episodes.

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[[Page 34616]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.047

    If no behavior assumptions were made, we estimate that the CY 2020 
30-day payment amount needed to achieve budget neutrality would be 
$1,907.11. Applying the clinical group and comorbidity coding 
assumptions, and the LUPA threshold assumption, as required by section 
1895(b)(3)(A)(iv) of the Act, will result in the need to decrease the 
CY 2020 estimated budget-neutral 30-day payment amount to $1,754.37 (a 
8.01 percent decrease from $1,907.11). The CY 2020 estimated 30-day 
budget-neutral payment amount would be slightly more than the CY 2019 
estimated 30-day budget-neutral payment amount calculated in last 
year's rule (that is, if the PDGM was implemented in CY 2019), which we 
estimated to be $1,753.68. However, the CY 2019 estimated 30-day 
payment amount of $1,753.68 included the CY 2019 market basket update 
of 2.1 percent whereas the CY 2020 estimated 30-day budget neutral 
payment amount of $1,754.37 does not include the 1.5 percent home 
health legislated payment update for CY 2020. Applying the proposed CY 
2020 Wage Index Budget Neutrality Factor and the 1.5 percent home 
health update would increase the CY 2020 national, standardized 30-day 
payment amount to $1,791.73 and is further described in section III.E. 
of this proposed rule. The CY 2020 proposed estimated payment rate of 
$1,791.73 is approximately 14 percent more than the estimated CY 2020 
30-day period cost of $1,577.52, as shown in Table 5 of this proposed 
rule. We invite comments on the CY 2020 proposed, estimated 30-day 
budget-neutral payment amount with the behavior assumptions as 
described previously in this proposed rule and in Table 12.
    The 30-day payment amount will be for 30-day periods of care 
beginning on and after January 1, 2020. Because CY 2020 is the first 
year of the PDGM and the change to a 30-day unit of payment, there will 
be a transition period to account for those home health episodes of 
care that span the implementation date. Therefore, for 60-day episodes 
(that is, not LUPA episodes) that begin on or before December 31, 2019 
and end on or after January 1, 2020 (episodes that would span the 
January 1, 2020 implementation date), payment made under the Medicare 
HH PPS will be the CY 2020 national, standardized 60-day episode 
payment amount as described in section III.X. of this proposed rule. 
For home health periods of care that begin on or after January 1, 2020, 
the unit of service will be a 30-day period and payment made under the 
Medicare HH PPS will be the CY 2020 national, standardized prospective 
30-day payment amount as described in section III.X. of this proposed 
rule. For home health units of service that begin on or after December 
3, 2020 through December 31, 2020 and end on or after January 1, 2021, 
the HHA will be paid the CY 2021 national, standardized prospective 30-
day payment amount.
    We note that we are also required under section 1895(b)(3)(D)(i) of 
the Act, as added by section 51001(a)(2)(B) of the BBA of 2018, to 
analyze data for CYs 2020 through 2026, after implementation of the 30-
day unit of payment and new case-mix adjustment methodology, to 
annually determine the impact of differences between assumed behavior 
changes and actual behavior changes on estimated aggregate 
expenditures. We interpret actual behavior change to encompass both 
behavior changes that were previously outlined, as assumed by CMS when 
determining the budget-neutral 30-day payment amount for CY 2020, and 
other behavior changes not identified at the time the 30-day payment 
amount for CY 2020 is determined. The data from CYs 2020 through 2026 
will be available to determine whether a prospective adjustment 
(increase or decrease) is needed no earlier than in years 2022 through 
2028 rulemaking. However, we will analyze data after implementation of 
the PDGM to determine if there are any notable and consistent trends to 
warrant whether any changes to the national, standardized 30-day 
payment rate should be done earlier than CY 2022.
    As noted previously, under section 1895(b)(3)(D)(ii) of the Act, we 
are required to provide one or more permanent adjustments to the 30-day 
payment amount on a prospective basis, if needed, to offset increases 
or decreases in estimated aggregate expenditures as calculated under 
section 1895(b)(3)(D)(i) of the Act. Clause (iii) of section 
1895(b)(3)(D) of the Act requires the Secretary to make temporary 
adjustments to the 30-day payment amount, on a prospective basis, in 
order to offset increases or decreases in estimated aggregate 
expenditures, as determined under clause (i) of such section. The 
temporary adjustments allow us to recover excess spending or give back 
the difference between actual and estimated spending (if actual is less 
than estimated) not addressed by permanent adjustments.

[[Page 34617]]

However, any permanent or temporary adjustments to the 30-day payment 
amount to offset increases or decreases in estimated aggregate 
expenditures as calculated under section 1895(b)(3)(D)(i) and (iii) of 
the Act would be subject to proposed notice and comment rulemaking.
    We are soliciting comments on the behavior assumptions finalized in 
the CY 2019 HH PPS final rule regarding any potential issues that may 
result from taking these assumptions into account when establishing the 
initial 30-day payment amount for CY 2020. We reiterate that if CMS 
underestimates the reductions to the 30-day payment amount necessary to 
offset behavior changes and maintain budget neutrality, larger 
adjustments to the 30-day payment amount would be required in the 
future, by law, to ensure budget neutrality. Likewise, if CMS 
overestimates the reductions, we are required to make the appropriate 
payment adjustments accordingly as described previously.
    We wish to remind stakeholders again that CMS will provide, upon 
request, a Home Health Claims-OASIS LDS file to accompany the CY 2020 
proposed and final rules to support HHAs in evaluating the effects of 
the PDGM. The Home Health Claims-OASIS LDS file can be requested by 
following the instructions on the following CMS website https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html. Additionally, we will 
post CY 2020 provider-level impacts and an updated Interactive Grouper 
Tool on the HHA Center web page \10\ and the PDGM dedicated web page 
\11\ to provide HHAs with ample tools to help them understand the 
impact of the PDGM and the change to a 30-day unit of payment.
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    \10\ https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html.
    \11\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.html.
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C. Proposed CY 2020 HH PPS Case-Mix Weights for 60-Day Episodes of Care 
That Span the Implementation Date of the PDGM

    In the CY 2015 HH PPS final rule (79 FR 66072), we finalized a 
policy to annually recalibrate the HH PPS case-mix weights--adjusting 
the weights relative to one another--using the most current, complete 
data available. Annual recalibration of the HH PPS case-mix weights 
ensures that the case-mix weights reflect, as accurately as possible, 
current home health resource use and changes in utilization patterns. 
In this proposed rule, we are detailing implementation of the PDGM and 
a change in the unit of home health payment to 30-day periods of care 
as described in section III.A and III.B. of this proposed rule. As 
such, we are recalibrating the CY 2020 case-mix weights for 30-day 
periods of care using the PDGM methodology as described in section 
III.D. of the proposed rule. However, these recalibrated case-mix 
weights are not applicable for those 60-day episodes of care that begin 
on or before December 31, 2019 and end on or after January 1, 2020. 
Therefore, we are not proposing to separately recalibrate the case-mix 
weights for those 60-day episodes that span the January 1, 2020 
implementation date.
    Instead, we are proposing that these 60-day episodes would be paid 
the national, standardized 60-day episode payment amount as described 
in section III.E. of this rule and will be case-mix adjusted using the 
CY 2019 case-mix weights as listed in Table 6 in the CY 2019 HH PPS 
final rule (83 FR 56422) and posted on the HHA Center web page.\12\ We 
believe that this is a reasonable approach for case-mix adjusting these 
60-day episodes of care that span the January 1, 2020 implementation 
date. With the implementation of a new case-mix adjustment methodology 
and a move to a 30-day unit of payment, we believe this approach would 
be less burdensome for HHAs as they will not have to download a new, 
separate 153-group case-mix weight data file, in addition to the 432 
case-mix weight data file for CY 2020. For those 60-day episodes that 
end after January 1, 2020, but where there is a continued need for home 
health services, we are proposing that any subsequent periods of care 
would be paid the 30-day national, standardized payment amount with the 
appropriate CY 2020 PDGM case-mix weight applied. We are soliciting 
comments on this proposal regarding payment for those 60-day episodes 
of care that span the implementation date of the PDGM and the change to 
a 30-day unit of payment.
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    \12\ https://www.cms.gov/center/provider-type/home-health-agency-hha-center.html.
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D. Proposed CY 2020 PDGM Low-Utilization Payment Adjustment (LUPA) 
Thresholds and PDGM Case-Mix Weights

1. Proposed CY 2020 PDGM LUPA Thresholds
    Under the current 153-group payment system, a 60-day episode with 
four or fewer visits is paid the national per-visit amount by 
discipline, adjusted by the appropriate wage index based on the site of 
service of the beneficiary, instead of the full 60-day episode payment 
amount. Such payment adjustments are called Low Utilization Payment 
Adjustments (LUPAs). In the current payment system, approximately 7 to 
8 percent of episodes are LUPAs.
    LUPAs will still be paid upon implementation of the PDGM. However, 
the approach to calculating the LUPA thresholds has changed due to the 
change in the unit of payment to 30-day periods of care from 60-day 
episodes. As detailed in the CY 2019 HH PPS proposed rule (83 FR 
32411), there are substantially more home health periods of care with 
four or fewer visits in a 30-day period than in 60-day episodes; 
therefore, we believe that the LUPA thresholds for 30-day periods of 
care should be correspondingly adjusted to target approximately the 
same percentage of LUPA episodes as under the current HH PPS case-mix 
system, which is approximately 7 to 8 percent of all episodes. To 
target approximately the same percentage of LUPAs under the PDGM, LUPA 
thresholds are set at the 10th percentile value of visits or 2 visits, 
whichever is higher, for each payment group. This means that the LUPA 
threshold for each 30-day period of care varies depending on the PDGM 
payment group to which it is assigned. In the CY 2019 HH PPS final rule 
(83 FR 56492), we finalized that the LUPA thresholds for each PDGM 
payment group will be reevaluated every year based on the most current 
utilization data available at the time of rulemaking. Therefore, we 
used CY 2018 Medicare home health claims (as of March 27, 2019) linked 
to OASIS assessment data for this proposed rule. The proposed LUPA 
thresholds for the CY 2020 PDGM payment groups with the corresponding 
Health Insurance Prospective Payment System (HIPPS) codes and the case-
mix weights are listed in Table 8. Under the PDGM, if the LUPA 
threshold is met, the 30-day period of care will be paid the full 30-
day period payment. If a 30-day period of care does not meet the PDGM 
LUPA visit threshold, as detailed previously, then payment will be made 
using the CY 2020 per-visit payment amounts. For example, if the LUPA 
visit threshold is four, and a 30-day period of care has four or more 
visits, it is paid the full 30-day period payment amount; if the period 
of care has three or less visits, payment is made using the per-visit 
payment amounts.

[[Page 34618]]

2. Proposed CY 2020 PDGM Case-Mix Weights
    Section 1895(b)(4)(B) of the Act requires the Secretary to 
establish appropriate case mix adjustment factors for home health 
services in a manner that explains a significant amount of the 
variation in cost among different units of services. As finalized in 
the CY 2019 HH PPS final rule (83 FR 56502), the PDGM places patients 
into meaningful payment categories based on patient characteristics 
(principal diagnosis, functional level, comorbid conditions, referral 
source and timing). The PDGM case-mix methodology results in 432 unique 
case-mix groups called HHRGs.
    To generate the CY 2020 PDGM case-mix weights, we utilized a data 
file based on home health 30-day periods of care, as reported in CY 
2018 Medicare home health claims (as of March 2019) linked to OASIS 
assessment data to obtain patient characteristics. These data are the 
most current and complete data available at this time. The claims data 
provides visit-level data and data on whether NRS was provided during 
the period and the total charges of NRS. We determine the case-mix 
weight for each of the 432 different PDGM payment groups by regressing 
resource use on a series of indicator variables for each of the 
categories using a fixed effects model as described in the steps 
detailed in this section of this proposed rule.
    Step 1: Estimate a regression model to assign a functional 
impairment level to each 30-day period. The regression model estimates 
the relationship between a 30-day period's resource use and the 
functional status and risk of hospitalization items included in the 
PDGM which are obtained from certain OASIS items. We measure resource 
use with the cost-per-minute + NRS approach that uses information from 
home health cost reports. Other variables in the regression model 
include the 30-day period's admission source; clinical group; and 30-
day period timing. We also include home health agency level fixed 
effects in the regression model. After estimating the regression model 
using 30-day periods, we divide the coefficients that correspond to the 
functional status and risk of hospitalization items by 10 and round to 
the nearest whole number. Those rounded numbers are used to compute a 
functional score for each 30-day period by summing together the rounded 
numbers for the functional status and risk of hospitalization items 
that are applicable to each 30-day period. Next, each 30-day period is 
assigned to a functional impairment level (low, medium, or high) 
depending on the 30-day period's total functional score. Each clinical 
group has a separate set of functional thresholds used to assign 30-day 
periods into a low, medium or high functional impairment level. We set 
those thresholds so that we assign roughly a third of 30-day periods 
within each clinical group to each functional impairment level (low, 
medium, or high).
    Step 2: Next, a second regression model estimates the relationship 
between a 30-day period's resource use and indicator variables for the 
presence of any of the comorbidities and comorbidity interactions that 
were originally examined for inclusion in the PDGM. Like the first 
regression model, this model also includes home health agency level 
fixed effects and includes control variables for each 30-day period's 
admission source, clinical group, timing, and functional impairment 
level. After we estimate the model, we assign comorbidities to the low 
comorbidity adjustment if any comorbidities have a coefficient that is 
statistically significant (p-value of .05 or less) and which have a 
coefficient that is larger than the 50th percentile of positive and 
statistically significant comorbidity coefficients. If two 
comorbidities in the model and their interaction term have coefficients 
that sum together to exceed $150 and the interaction term is 
statistically significant (p-value of .05 or less), we assign the two 
comorbidities together to the high comorbidity adjustment.
    Step 3: After Step 2, each 30-day period is assigned to a clinical 
group, admission source category, episode timing category, functional 
impairment level, and comorbidity adjustment category. For each 
combination of those variables (which represent the 432 different 
payment groups that comprise the PDGM), we then calculate the 10th 
percentile of visits across all 30-day periods within a particular 
payment group. If a 30-day period's number of visits is less than the 
10th percentile for their payment group, the 30-day period is 
classified as a Low Utilization Payment Adjustment (LUPA). If a payment 
group has a 10th percentile of visits that is less than two, we set the 
LUPA threshold for that payment group to be equal to two. That means if 
a 30-day period has one visit, it is classified as a LUPA and if it has 
two or more visits, it is not classified as a LUPA.
    Step 4: Finally, we take all non-LUPA 30-day periods and regress 
resource use on the 30-day period's clinical group, admission source 
category, episode timing category, functional impairment level, and 
comorbidity adjustment category. The regression includes fixed effects 
at the level of the home health agency. After we estimate the model, 
the model coefficients are used to predict each 30-day period's 
resource use. To create the case-mix weight for each 30-day period, the 
predicted resource use is divided by the overall resource use of the 
30-day periods used to estimate the regression.
    The case-mix weight is then used to adjust the base payment rate to 
determine each 30-day period's payment. Table 13 shows the coefficients 
of the payment regression used to generate the weights, and the 
coefficients divided by average resource use.

[[Page 34619]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.048

    Table 14 presents the HIPPS code, the LUPA threshold, and the case-
mix weight for each Home Health Resource Group (HHRG) in the regression 
model.
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BILLING CODE 4120-01-C

E. Proposed CY 2020 Home Health Payment Rate Updates

1. Proposed CY 2020 Home Health Market Basket Update for HHAs
    Section 1895(b)(3)(B) of the Act requires that the standard 
prospective payment amounts for CY 2020 be increased by a factor equal 
to the applicable home health market basket update for those HHAs that 
submit quality data as required by the Secretary. In the CY 2019 HH PPS 
final rule (83 FR 56425), we finalized a rebasing of the home health 
market basket to reflect 2016 Medicare cost report (MCR) data, the 
latest available and complete data on the actual structure of HHA 
costs. As such, based on the rebased 2016-based home health market 
basket, we finalized that the labor-related share is 76.1 percent and 
the non-labor-related share is 23.9 percent. A detailed description of 
how we rebased the HHA market basket is available in the CY 2019 HH PPS 
final rule (83 FR 56425 through 56436).
    Section 1895(b)(3)(B) of the Act, requires that, in CY 2015 and in 
subsequent calendar years, except CY 2018 (under section 411(c) of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 
114-10, enacted April 16, 2015)), and except in CY 2020 (under section 
53110 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, 
enacted February 9, 2018)), the market basket percentage under the HHA 
prospective payment system, as described in section 1895(b)(3)(B) of 
the Act, be annually adjusted by changes in economy-wide productivity. 
Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity 
adjustment to be equal to the 10-year moving average of change in 
annual economy-wide private nonfarm business multifactor productivity 
(MFP) (as projected by the Secretary for the 10-year period ending with 
the applicable fiscal year, calendar year, cost reporting period, or 
other annual period) (the ``MFP adjustment''). The Bureau of Labor 
Statistics (BLS) is the agency that publishes the official measure of 
private nonfarm business MFP. Please see https://www.bls.gov/mfp, to 
obtain the BLS historical published MFP data.
    The proposed home health update percentage for CY 2020 would have 
been based on the estimated home health market basket update, specified 
at section 1895(b)(3)(B)(iii) of the Act, of 3.0 percent (based on IHS 
Global Insight Inc.'s first-quarter 2019 forecast with historical data 
through fourth-quarter 2018). Due to the requirements specified at 
section 1895(b)(3)(B)(vi) of the Act prior to the enactment of the BBA 
of 2018, the estimated CY 2020 home health market basket update of 3.0 
percent would have been reduced by a MFP adjustment, as mandated by the 
section 3401 of the Patient Protection and Affordable Care Act (the 
Affordable Care Act) (Pub. L. 111-148) and currently estimated to be 
0.4 percentage point for CY 2020. In effect, the proposed home health 
payment update percentage for CY 2020 would have been a 2.6 percent 
increase. However, section 53110 of the BBA of 2018 amended section 
1895(b)(3)(B) of the Act, such that for home health payments for CY 
2020, the home health payment update is required to be 1.5 percent. The 
MFP adjustment is not applied to the BBA of 2018 mandated 1.5 percent 
payment update. Section 1895(b)(3)(B)(v) of the Act requires that the 
home health update be decreased by 2 percentage points for those HHAs 
that do not submit quality data as required by the Secretary. For HHAs 
that do not submit the required quality data for CY 2020, the home 
health payment update would be -0.5 percent (1.5 percent minus 2 
percentage points).
2. CY 2020 Home Health Wage Index
    Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the 
Secretary to provide appropriate adjustments to the proportion of the 
payment amount under the HH PPS that account for area wage differences, 
using adjustment factors that reflect the relative level of wages and 
wage-related costs applicable to the furnishing of HH services. Since 
the inception of the HH PPS, we have used inpatient hospital wage data 
in developing a wage index to be applied to HH payments. We propose to 
continue this practice for CY 2020, as we continue to believe that, in 
the absence of HH-specific wage data that accounts for area 
differences, using inpatient hospital wage data is appropriate and 
reasonable for the HH PPS. Specifically, we propose to use the FY 2020 
pre-floor, pre-reclassified hospital wage index as the CY 2020 wage 
adjustment to the labor portion of the HH PPS rates. For CY 2020, the 
updated wage data are for hospital cost reporting periods beginning on 
or after October 1, 2015, and before October 1, 2016 (FY 2016 cost 
report data). We apply the appropriate wage index value to the labor 
portion of the HH PPS rates based on the site of service for the 
beneficiary (defined by section 1861(m) of the Act as the beneficiary's 
place of residence).
    To address those geographic areas in which there are no inpatient 
hospitals, and thus, no hospital wage data on which to base the 
calculation of the CY 2020 HH PPS wage index, we propose to continue to 
use the same methodology discussed in the CY 2007 HH PPS final rule (71 
FR 65884) to address those geographic areas in which there are no 
inpatient hospitals. For rural areas that do not have inpatient 
hospitals, we propose to use the average wage index from all contiguous 
Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently, 
the only

[[Page 34629]]

rural area without a hospital from which hospital wage data could be 
derived is Puerto Rico. However, for rural Puerto Rico, we do not apply 
this methodology due to the distinct economic circumstances that exist 
there (for example, due to the close proximity to one another of almost 
all of Puerto Rico's various urban and non-urban areas, this 
methodology would produce a wage index for rural Puerto Rico that is 
higher than that in half of its urban areas). Instead, we propose to 
continue to use the most recent wage index previously available for 
that area. For urban areas without inpatient hospitals, we use the 
average wage index of all urban areas within the state as a reasonable 
proxy for the wage index for that CBSA. For CY 2020, the urban areas 
without inpatient hospital wage data are Hinesville, GA (CBSA 25980) 
and Carson City, NV (CBSA 16180). The CY 2020 wage index value for 
Hinesville, GA is 0.8237 and the wage index value for Carson City, NV 
is 1.0518.
    On February 28, 2013, OMB issued Bulletin No. 13-01, announcing 
revisions to the delineations of MSAs, Micropolitan Statistical Areas, 
and CBSAs, and guidance on uses of the delineation of these areas. In 
the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted 
the OMB's new area delineations using a 1-year transition.
    On August 15, 2017, OMB issued Bulletin No. 17-01 in which it 
announced that one Micropolitan Statistical Area, Twin Falls, Idaho, 
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300) 
comprises the principal city of Twin Falls, Idaho in Jerome County, 
Idaho and Twin Falls County, Idaho. The CY 2020 HH PPS wage index value 
for CBSA 46300, Twin Falls, Idaho, will be 0.8252. Bulletin No. 17-01 
is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.\13\
---------------------------------------------------------------------------

    \13\ ``Revised Delineations of Metropolitan Statistical Areas, 
Micropolitan Statistical Areas, and Combined Statistical Areas, and 
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN 
NO. 17-01. August 15, 2017. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
---------------------------------------------------------------------------

    The most recent OMB Bulletin (No. 18-04) was published on September 
14, 2018 and is available at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.\14\
---------------------------------------------------------------------------

    \14\ Revised Delineations of Metropolitan Statistical Areas, 
Micropolitan Statistical Areas, and Combined Statistical Areas, and 
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN 
NO. 18-04. September 14, 2018. https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
---------------------------------------------------------------------------

    The revisions contained in OMB Bulletin No. 18-04 have no impact on 
the geographic area delineations that are used to wage adjust HH PPS 
payments.
    The CY 2020 wage index is available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. We 
were recently made aware of a minor calculation error in the file used 
to compute the home health wage index values. We are also posting the 
corrected wage index values in the same file, on the same website and 
we will correct this error when computing the home health wage index 
values and payment rates for the final rule.
3. Comment Solicitation
    Historically, we have calculated the home health wage index values 
using unadjusted wage index values from another provider setting. 
Stakeholders have frequently commented on certain aspects of the home 
health wage index values and their impact on payments. We are 
soliciting comments on concerns stakeholders may have regarding the 
wage index used to adjust home health payments and suggestions for 
possible updates and improvements to the geographic adjustment of home 
health payments.
4. CY 2020 Annual Payment Update
a. Background
    The Medicare HH PPS has been in effect since October 1, 2000. As 
set forth in the July 3, 2000 final rule (65 FR 41128), the base unit 
of payment under the Medicare HH PPS was a national, standardized 60-
day episode payment rate. As finalized in the CY 2019 HH PPS final rule 
(83 FR 56406) and as described in section III.B of this proposed rule, 
the unit of home health payment will change from a 60-day episode to a 
30-day period effective for those 30-day periods beginning on or after 
January 1, 2020. However, the standardized 60-day payment rate will 
apply to case-mix adjusted episodes (that is, not LUPAs) beginning on 
or before December 31, 2019 and ending on or before February 28, 2020. 
As such, the latest date such a 60-day crossover episode could end on 
is February 28, 2020. Those 60-day episodes that begin on or before 
December 31, 2019, but are LUPA episodes, will be paid the national, 
per-visit payment rates as shown in Table 23.
    As set forth in Sec.  484.220, we adjust the national, standardized 
prospective payment rates by a case-mix relative weight and a wage 
index value based on the site of service for the beneficiary. To 
provide appropriate adjustments to the proportion of the payment amount 
under the HH PPS to account for area wage differences, we apply the 
appropriate wage index value to the labor portion of the HH PPS rates. 
In the CY 2019 HH PPS final rule (83 FR 56435), we finalized to rebase 
and revise the home health market basket to reflect 2016 Medicare cost 
report (MCR) data, the latest available and most complete data on the 
actual structure of HHA costs. We also finalized a revision to the 
labor-related share to reflect the 2016-based home health market basket 
Compensation (Wages and Salaries plus Benefits) cost weight. We 
finalized that for CY 2019 and subsequent years, the labor-related 
share would be 76.1 percent and the non-labor-related share would be 
23.9 percent. The following are the steps we take to compute the case-
mix and wage-adjusted 60-day episode (for those episodes that span the 
implementation date of January 1, 2020) and 30-day period rates for CY 
2020:
     Multiply the national, standardized 60-day episode rate or 
30-day period rate by the patient's applicable case-mix weight.
     Divide the case-mix adjusted amount into a labor (76.1 
percent) and a non-labor portion (23.9 percent).
     Multiply the labor portion by the applicable wage index 
based on the site of service of the beneficiary.
     Add the wage-adjusted portion to the non-labor portion, 
yielding the case-mix and wage adjusted 60-day episode rate or 30-day 
period rate, subject to any additional applicable adjustments.
    We provide annual updates of the HH PPS rate in accordance with 
section 1895(b)(3)(B) of the Act. Section 484.225 sets forth the 
specific annual percentage update methodology. In accordance with 
section 1895(b)(3)(B)(v) of the Act and Sec.  484.225(i), for an HHA 
that does not submit HH quality data, as specified by the Secretary, 
the unadjusted national prospective 60-day episode rate or 30-day 
period rate is equal to the rate for the previous calendar year 
increased by the applicable HH payment update, minus 2 percentage 
points. Any reduction of the percentage change would apply only to the 
calendar year involved and would not be considered in computing the 
prospective payment amount for a subsequent calendar year.
    Medicare pays both the national, standardized 60-day and 30-day 
case-mix and wage-adjusted payment amounts on a split percentage 
payment approach for those HHAs eligible for such payments. The split 
percentage payment approach includes an initial percentage payment and 
a final

[[Page 34630]]

percentage payment as set forth in Sec.  484.205(b)(1) and (2). The 
claim that the HHA submits for the final percentage payment determines 
the total payment amount for the episode or period and whether we make 
an applicable adjustment to the 60-day or 30-day case-mix and wage-
adjusted payment amount. We refer stakeholders to section III.H. of 
this proposed rule regarding proposals on changes to the current split 
percentage policy in CY 2020 and subsequent years. The end date of the 
60-day episode or 30-day period, as reported on the claim, determines 
which calendar year rates Medicare will use to pay the claim.
    We may also adjust the 60-day or 30-day case-mix and wage-adjusted 
payment based on the information submitted on the claim to reflect the 
following:
     A low-utilization payment adjustment (LUPA) is provided on 
a per-visit basis as set forth in Sec. Sec.  484.205(d)(1) and 484.230.
     A partial episode payment (PEP) adjustment as set forth in 
Sec. Sec.  484.205(d)(2) and 484.235.
     An outlier payment as set forth in Sec. Sec.  
484.205(d)(3) and 484.240.
b. CY 2020 National, Standardized 60-Day Episode Payment Rate
    Section 1895(b)(3)(A)(i) of the Act requires that the standard, 
prospective payment rate and other applicable amounts be standardized 
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a 
budget neutral manner. To determine the CY 2020 national, standardized 
60-day episode payment rate for those 60-day episodes that span the 
implementation date of the PDGM and the change to a 30-day unit of 
payment, we apply a wage index budget neutrality factor and the home 
health payment update percentage discussed in section III.F.1. of this 
proposed rule. We are not proposing to update the case-mix weights for 
the 153-group case-mix methodology in CY 2020 as outlined in section 
III.D. of this proposed rule. Because we would continue to use the CY 
2019 case-mix weights, we do not have to apply a case-mix weight budget 
neutrality factor to the CY 2020 60-day episode payment rate.
    To calculate the wage index budget neutrality factor, we simulated 
total payments for non-LUPA episodes using the proposed CY 2020 wage 
index and compared it to our simulation of total payments for non-LUPA 
episodes using the CY 2019 wage index. By dividing the total payments 
for non-LUPA episodes using the CY 2020 wage index by the total 
payments for non-LUPA episodes using the CY 2019 wage index, we obtain 
a wage index budget neutrality factor of 1.0062. We would apply the 
wage index budget neutrality factor of 1.0062 to the calculation of the 
CY 2019 national, standardized 60-day episode payment rate.
    Next, we would update the 60-day payment rate by the CY 2020 home 
health payment update percentage of 1.5 percent as required by section 
53110 of the BBA of 2018 and as described in section III.E.1. of this 
proposed rule. The CY 2020 national, standardized 60-day episode 
payment rate is calculated in Table 15.
[GRAPHIC] [TIFF OMITTED] TP18JY19.058

    The CY 2020 national, standardized 60-day episode payment rate for 
an HHA that does not submit the required quality data is updated by the 
CY 2020 home health payment update of 1.5 percent minus 2 percentage 
points and is shown in Table 16.
[GRAPHIC] [TIFF OMITTED] TP18JY19.059

 c. CY 2020 Non-Routine Medical Supply (NRS) Payment Rates for CY 2020 
60-Day Episodes of Care
    All medical supplies (routine and non-routine) must be provided by 
the HHA while the patient is under a home health plan of care. Examples 
of supplies that can be considered non-routine include dressings for 
wound care, IV supplies, ostomy supplies, catheters, and catheter 
supplies. Payments for NRS are computed by multiplying the relative 
weight for a particular severity level by the NRS conversion factor. To 
determine the CY

[[Page 34631]]

2020 NRS conversion factor, we updated the CY 2019 NRS conversion 
factor ($54.20) by the CY 2020 home health payment update percentage of 
1.5 percent. We did not apply a standardization factor as the NRS 
payment amount calculated from the conversion factor is not wage or 
case-mix adjusted when the final claim payment amount is computed. The 
proposed NRS conversion factor for CY 2020 is shown in Table 17.
[GRAPHIC] [TIFF OMITTED] TP18JY19.060

    Using the CY 2020 NRS conversion factor, the payment amounts for 
the six severity levels are shown in Table 18.
[GRAPHIC] [TIFF OMITTED] TP18JY19.061

    For HHAs that do not submit the required quality data, we updated 
the CY 2019 NRS conversion factor ($54.20) by the CY 2019 home health 
payment update percentage of 1.5 percent minus 2 percentage points. To 
determine the CY 2020 NRS conversion factor for HHAs that do not submit 
the required quality data we multiplied the CY 2019 NRS conversion 
factor ($54.20) by the CY 2020 HH Payment Update (0.995) to determine 
the CY 2020 NRS conversion factor ($53.93). The proposed CY 2020 NRS 
conversion factor for HHAs that do not submit quality data is shown in 
Table 19.
[GRAPHIC] [TIFF OMITTED] TP18JY19.062

    The payment amounts for the various severity levels based on the 
updated conversion factor for HHAs that do not submit quality data are 
calculated in Table 20.

[[Page 34632]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.063

    In CY 2020, the NRS payment amounts apply to only those 60-day 
episodes that begin on or before December 31, 2019 but span the 
implementation of the PDGM and the 30-day unit of payment on January 1, 
2020 (ending on February 28, 2020). Under the PDGM, NRS payments are 
included in the 30-day base payment rate.
d. CY 2020 National, Standardized 30-Day Period Payment Amount
    Section 1895(b)(3)(A)(i) of the Act requires that the standard 
prospective payment rate and other applicable amounts be standardized 
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a 
budget-neutral manner. To determine the CY 2020 national, standardized 
30-day period payment rate, we apply a wage index budget neutrality 
factor; and the home health payment update percentage discussed in 
section III.E.1. of this proposed rule.
    To calculate the wage index budget neutrality factor, we simulated 
total payments for non-LUPA episodes using the proposed CY 2020 wage 
index and compared it to our simulation of total payments for non-LUPA 
episodes using the CY 2019 wage index. By dividing the total payments 
for non-LUPA episodes using the CY 2020 wage index by the total 
payments for non-LUPA episodes using the CY 2019 wage index, we obtain 
a wage index budget neutrality factor of 1.0062. We would apply the 
wage index budget neutrality factor of 1.0062 to the calculation of the 
CY 2019 national, standardized 30-day period payment rate as described 
in section III.B. of this proposed rule.
    We note that in past years, a case-mix budget neutrality factor was 
annually applied to the HH PPS base rates to account for the change 
between the previous year's case-mix weights and the newly recalibrated 
case-mix weights. Since CY 2020 is the first year of PDGM, there is no 
way to do a case-mix budget neutrality factor in this manner. However, 
in future years under the PDGM, we would apply a case-mix budget 
neutrality factor with the annual payment update in order to account 
for the change between the previous year's PDGM case-mix weights.
    Next, we would update the 30-day payment rate by the CY 2020 home 
health payment update percentage of 1.5 percent as required by section 
53110 of the BBA of 2018 and as described in section III.F.1. of this 
proposed rule. The CY 2020 national, standardized 30-day period payment 
rate is calculated in Table 21.
[GRAPHIC] [TIFF OMITTED] TP18JY19.064

    The CY 2020 national, standardized 30-day episode payment rate for 
an HHA that does not submit the required quality data is updated by the 
CY 2020 home health payment update of 1.5 percent minus 2 percentage 
points and is shown in Table 22.

[[Page 34633]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.065

e. CY 2020 National Per-Visit Rates for Both 60-Day Episodes of Care 
and 30-Day Periods of Care
    The national per-visit rates are used to pay LUPAs and are also 
used to compute imputed costs in outlier calculations. The per-visit 
rates are paid by type of visit or HH discipline. The six HH 
disciplines are as follows:
     Home health aide (HH aide).
     Medical Social Services (MSS).
     Occupational therapy (OT).
     Physical therapy (PT).
     Skilled nursing (SN).
     Speech-language pathology (SLP).
    To calculate the CY 2020 national per-visit rates, we started with 
the CY 2019 national per-visit rates. Then we applied a wage index 
budget neutrality factor to ensure budget neutrality for LUPA per-visit 
payments. We calculated the wage index budget neutrality factor by 
simulating total payments for LUPA episodes using the CY 2020 wage 
index and comparing it to simulated total payments for LUPA episodes 
using the CY 2019 wage index. By dividing the total payments for LUPA 
episodes using the CY 2020 wage index by the total payments for LUPA 
episodes using the CY 2019 wage index, we obtained a wage index budget 
neutrality factor of 1.0066. We apply the wage index budget neutrality 
factor of 1.0066 in order to calculate the CY 2020 national per-visit 
rates.
    The LUPA per-visit rates are not calculated using case-mix weights. 
Therefore, no case-mix weights budget neutrality factor is needed to 
ensure budget neutrality for LUPA payments. Lastly, the per-visit rates 
for each discipline are updated by the CY 2020 home health payment 
update percentage of 1.5 percent. The national per-visit rates are 
adjusted by the wage index based on the site of service of the 
beneficiary. The per-visit payments for LUPAs are separate from the 
LUPA add-on payment amount, which is paid for episodes that occur as 
the only episode or initial episode in a sequence of adjacent episodes. 
The CY 2020 national per-visit rates for HHAs that submit the required 
quality data are updated by the CY 2020 HH payment update percentage of 
1.5 percent and are shown in Table 23.
[GRAPHIC] [TIFF OMITTED] TP18JY19.066

    The CY 2020 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the CY 2020 HH payment update 
percentage of 1.5 percent minus 2 percentage points and are shown in 
Table 24.

[[Page 34634]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.067

f. Rural Add-On Payments for CYs 2020 Through 2022
1. Background
    Section 421(a) of the Medicare Prescription Drug Improvement and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) required, for HH 
services furnished in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), for episodes or visits ending on or after April 1, 2004, 
and before April 1, 2005, that the Secretary increase the payment 
amount that otherwise would have been made under section 1895 of the 
Act for the services by 5 percent. Section 5201 of the Deficit 
Reduction Act of 2003 (DRA) (Pub. L. 108-171) amended section 421(a) of 
the MMA. The amended section 421(a) of the MMA required, for HH 
services furnished in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), on or after January 1, 2006, and before January 1, 2007, 
that the Secretary increase the payment amount otherwise made under 
section 1895 of the Act for those services by 5 percent.
    Section 3131(c) of the Affordable Care Act amended section 421(a) 
of the MMA to provide an increase of 3 percent of the payment amount 
otherwise made under section 1895 of the Act for HH services furnished 
in a rural area (as defined in section 1886(d)(2)(D) of the Act), for 
episodes and visits ending on or after April 1, 2010, and before 
January 1, 2016. Section 210 of the MACRA amended section 421(a) of the 
MMA to extend the rural add-on by providing an increase of 3 percent of 
the payment amount otherwise made under section 1895 of the Act for HH 
services provided in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), for episodes and visits ending before January 1, 2018.
    Section 50208(a) of the BBA of 2018 amended section 421(a) of the 
MMA to extend the rural add-on by providing an increase of 3 percent of 
the payment amount otherwise made under section 1895 of the Act for HH 
services provided in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), for episodes and visits ending before January 1, 2019.
2. Rural Add-On Payments for CYs 2020 Through 2022
    Section 50208(a)(1)(D) of the BBA of 2018 added a new subsection 
(b) to section 421 of the MMA to provide rural add-on payments for 
episodes or visits ending during CYs 2019 through 2022. It also 
mandated implementation of a new methodology for applying those 
payments. Unlike previous rural add-ons, which were applied to all 
rural areas uniformly, the extension provided varying add-on amounts 
depending on the rural county (or equivalent area) classification by 
classifying each rural county (or equivalent area) into one of three 
distinct categories: (1) Rural counties and equivalent areas in the 
highest quartile of all counties and equivalent areas based on the 
number of Medicare home health episodes furnished per 100 individuals 
who are entitled to, or enrolled for, benefits under Part A of Medicare 
or enrolled for benefits under part B of Medicare only, but not 
enrolled in a Medicare Advantage plan under part C of Medicare (the 
``High utilization'' category); (2) rural counties and equivalent areas 
with a population density of 6 individuals or fewer per square mile of 
land area and are not included in the ``High utilization'' category 
(the ``Low population density'' category); and (3) rural counties and 
equivalent areas not in either the ``High utilization'' or ``Low 
population density'' categories (the ``All other'' category).
    In the CY 2019 HH PPS final rule (83 FR 56443), CMS finalized 
policies for the rural add-on payments for CY 2019 through CY 2022, in 
accordance with section 50208 of the BBA of 2018. The CY 2019 HH PPS 
proposed rule (83 FR 32373) described the provisions of the rural add-
on payments, the methodology for applying the new payments, and 
outlined how we categorized rural counties (or equivalent areas) based 
on claims data, the Medicare Beneficiary Summary File and Census data. 
The data used to categorize each county or equivalent area is available 
in the Downloads section associated with the publication of this rule 
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file containing the rural county or 
equivalent area name, their Federal Information Processing Standards 
(FIPS) state and county codes, and their designation into one of the 
three rural add-on categories is available for download.
    The HH PRICER module, located within CMS' claims processing system, 
will increase the proposed CY 2020 60-day and 30-day base payment rates 
described in section III.E. of this proposed rule by the appropriate 
rural add-on percentage prior to applying any case-mix and wage index 
adjustments. The CY 2020 through 2022 rural add-on percentages outlined 
in law are shown in Table 25.

[[Page 34635]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.068

g. Low-Utilization Payment Adjustment (LUPA) Add-On Factors and Partial 
Payment Adjustments
    Currently, LUPA episodes qualify for an add-on payment when the 
episode is the first or only episode in a sequence of adjacent 
episodes. As stated in the CY 2008 HH PPS final rule, LUPA add-on 
payments are made because the national per-visit payment rates do not 
adequately account for the front-loading of costs for the first LUPA 
episode of care as the average visit lengths in these initial LUPAs are 
16 to 18 percent higher than the average visit lengths in initial non-
LUPA episodes (72 FR 49848). LUPA episodes that occur as the only 
episode or as an initial episode in a sequence of adjacent episodes are 
adjusted by applying an additional amount to the LUPA payment before 
adjusting for area wage differences. In the CY 2014 HH PPS final rule 
(78 FR 72305), we changed the methodology for calculating the LUPA add-
on amount by finalizing the use of three LUPA add-on factors: 1.8451 
for SN; 1.6700 for PT; and 1.6266 for SLP. We multiply the per-visit 
payment amount for the first SN, PT, or SLP visit in LUPA episodes that 
occur as the only episode or an initial episode in a sequence of 
adjacent episodes by the appropriate factor to determine the LUPA add-
on payment amount.
    In the CY 2019 HH PPS final rule (83 FR 56440), we finalized our 
policy of continuing to multiply the per-visit payment amount for the 
first skilled nursing, physical therapy, or speech-language pathology 
visit in LUPA periods that occur as the only period of care or the 
initial 30-day period of care in a sequence of adjacent 30-day periods 
of care by the appropriate add-on factor (1.8451 for SN, 1.6700 for PT, 
and 1.6266 for SLP) to determine the LUPA add-on payment amount for 30-
day periods of care under the PDGM. For example, using the proposed CY 
2020 per-visit payment rates for those HHAs that submit the required 
quality data, for LUPA periods that occur as the only period or an 
initial period in a sequence of adjacent periods, if the first skilled 
visit is SN, the payment for that visit will be $276.14 (1.8451 
multiplied by $149.66), subject to area wage adjustment.
    Also in the CY 2019 HH PPS final rule (83 FR 56516), we finalized 
our policy that the process for partial payment adjustments for 30-day 
periods of care will remain the same as the process for 60-day 
episodes. The partial episode payment (PEP) adjustment is a proportion 
of the period payment and is based on the span of days including the 
start-of-care date (for example, the date of the first billable 
service) through and including the last billable service date under the 
original plan of care before the intervening event in a home health 
beneficiary's care defined as a--
     Beneficiary elected transfer, or
     Discharge and return to home health that would warrant, 
for purposes of payment, a new OASIS assessment, physician 
certification of eligibility, and a new plan of care.
    When a new 30-day period begins due to an intervening event, the 
original 30-day period will be proportionally adjusted to reflect the 
length of time the beneficiary remained under the agency's care prior 
to the intervening event. The proportional payment is the partial 
payment adjustment. The partial payment adjustment will be calculated 
by using the span of days (first billable service date through and 
including the last billable service date) under the original plan of 
care as a proportion of the 30-day period. The proportion will then be 
multiplied by the original case-mix and wage index to produce the 30-
day payment.

F. Proposed Payments for High-Cost Outliers Under the H PPS

1. Background
    Section 1895(b)(5) of the Act allows for the provision of an 
addition or adjustment to the home health payment amount otherwise made 
in the case of outliers because of unusual variations in the type or 
amount of medically necessary care. Under the HH PPS, outlier payments 
are made for episodes whose estimated costs exceed a threshold amount 
for each Home Health Resource Group (HHRG). The episode's estimated 
cost was established as the sum of the national wage-adjusted per-visit 
payment amounts delivered during the episode. The outlier threshold for 
each case-mix group or partial episode payment (PEP) adjustment is 
defined as the 60-day episode payment or PEP adjustment for that group 
plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS, 
the FDL amount is calculated by multiplying the HH FDL ratio by a 
case's wage-adjusted national, standardized 60-day episode payment 
rate, which yields an FDL dollar amount for the case. The outlier 
threshold amount is the sum of the wage and case-mix adjusted PPS 
episode amount and wage-adjusted FDL amount. The outlier payment is 
defined to be a proportion of the wage-adjusted estimated cost that 
surpasses the wage-adjusted threshold. The proportion of additional 
costs over the outlier threshold amount paid as outlier payments is 
referred to as the loss-sharing ratio.
    As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 
70399), section 3131(b)(1) of the Affordable Care Act amended section 
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH 
PPS payment rates such that aggregate HH PPS payments were reduced by 5 
percent. In addition, section 3131(b)(2) of the Affordable Care Act 
amended section 1895(b)(5) of the Act by re-designating the existing 
language as section 1895(b)(5)(A) of the Act and revising the language 
to state that the total amount of the additional payments or payment 
adjustments for outlier episodes could not exceed 2.5 percent of the 
estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of 
the Affordable Care Act also added section 1895(b)(5)(B) of the Act, 
which capped outlier payments as a percent of total payments for each 
HHA for each year at 10 percent.
    As such, beginning in CY 2011, we reduced payment rates by 5 
percent and targeted up to 2.5 percent of total estimated HH PPS 
payments to be paid as outliers. To do so, we first returned the 2.5 
percent held for the target CY 2010 outlier pool to the national, 
standardized 60-day episode rates, the national per visit rates, the 
LUPA add-on payment amount, and the NRS conversion factor for CY 2010. 
We then reduced the rates by 5 percent as

[[Page 34636]]

required by section 1895(b)(3)(C) of the Act, as amended by section 
3131(b)(1) of the Affordable Care Act. For CY 2011 and subsequent 
calendar years we targeted up to 2.5 percent of estimated total 
payments to be paid as outlier payments, and apply a 10 percent agency-
level outlier cap.
    In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 
43742 and 81 FR 76702), we described our concerns regarding patterns 
observed in home health outlier episodes. Specifically, we noted that 
the methodology for calculating home health outlier payments may have 
created a financial incentive for providers to increase the number of 
visits during an episode of care in order to surpass the outlier 
threshold; and simultaneously created a disincentive for providers to 
treat medically complex beneficiaries who require fewer but longer 
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 
76702), we finalized changes to the methodology used to calculate 
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate 
payment for outlier episodes, accounting for both the number of visits 
during an episode of care and also the length of the visits provided. 
Using this approach, we now convert the national per-visit rates into 
per 15-minute unit rates. These per 15-minute unit rates are used to 
calculate the estimated cost of an episode to determine whether the 
claim will receive an outlier payment and the amount of payment for an 
episode of care. In conjunction with our finalized policy to change to 
a cost-per-unit approach to estimate episode costs and determine 
whether an outlier episode should receive outlier payments, in the CY 
2017 HH PPS final rule we also finalized the implementation of a cap on 
the amount of time per day that would be counted toward the estimation 
of an episode's costs for outlier calculation purposes (81 FR 76725). 
Specifically, we limit the amount of time per day (summed across the 
six disciplines of care) to 8 hours (32 units) per day when estimating 
the cost of an episode for outlier calculation purposes.
    We plan to publish the cost-per-unit amounts for CY 2020 in the 
rate update change request, which is issued after the publication of 
the CY 2020 HH PPS final rule. We note that in the CY 2017 HH PPS final 
rule (81 FR 76724), we stated that we did not plan to re-estimate the 
average minutes per visit by discipline every year. Additionally, we 
noted that the per-unit rates used to estimate an episode's cost will 
be updated by the home health update percentage each year, meaning we 
would start with the national per-visit amounts for the same calendar 
year when calculating the cost-per-unit used to determine the cost of 
an episode of care (81 FR 76727). We note that we will continue to 
monitor the visit length by discipline as more recent data become 
available, and we may propose to update the rates as needed in the 
future.
    In the CY 2019 HH PPS final rule (83 FR 56521), we finalized a 
policy to maintain the current methodology for payment of high-cost 
outliers upon implementation of the PDGM beginning in CY 2020 and that 
we will calculate payment for high-cost outliers based upon 30-day 
periods of care. The calculation of the proposed fixed-dollar loss 
ratio for CY 2020 for both the 60-day episodes that span the 
implementation date, and for 30-day periods of care beginning on and 
after January 1, 2020 is detailed in this section.
2. Proposed Fixed Dollar Loss (FDL) Ratio for CY 2020
    For a given level of outlier payments, there is a trade-off between 
the values selected for the FDL ratio and the loss-sharing ratio. A 
high FDL ratio reduces the number of episodes or periods that can 
receive outlier payments, but makes it possible to select a higher 
loss-sharing ratio, and therefore, increase outlier payments for 
qualifying outlier episodes or periods. Alternatively, a lower FDL 
ratio means that more episodes or periods can qualify for outlier 
payments, but outlier payments per episode or per period must then be 
lower.
    The FDL ratio and the loss-sharing ratio must be selected so that 
the estimated total outlier payments do not exceed the 2.5 percent 
aggregate level (as required by section 1895(b)(5)(A) of the Act). 
Historically, we have used a value of 0.80 for the loss-sharing ratio 
which, we believe, preserves incentives for agencies to attempt to 
provide care efficiently for outlier cases. With a loss-sharing ratio 
of 0.80, Medicare pays 80 percent of the additional estimated costs 
that exceed the outlier threshold amount.
    In the CY 2019 HH PPS final rule (83 FR 56439), we finalized a FDL 
ratio of 0.51 to pay up to, but no more than, 2.5 percent of total 
payments as outlier payments. For CY 2020, we are not proposing to 
update the FDL ratio for those 60-day episodes that span the 
implementation date of the PDGM; we would keep the FDL ratio for 60-day 
episodes in CY 2020 at 0.51. For this CY 2020 proposed rule, simulating 
payments using preliminary CY 2018 claims data (as of January 2019) and 
the CY 2019 HH PPS payment rates, we estimate that outlier payments in 
CY 2019 would comprise 2.42 percent of total payments for those 60-day 
episodes that span into 2020 and are paid under the national, 
standardized 60-day payment rate (with an FDL of 0.51) and 2.5 percent 
of total payments for PDGM 30-day periods using the 30-day budget-
neutral payment amount as detailed in section III.B. of this proposed 
rule (with an FDL of 0.63). Given the statutory requirement that total 
outlier payments not exceed 2.5 percent of the total payments estimated 
to be made under the HH PPS, we are proposing that the FDL ratio for 
30-day periods of care in CY 2020 would need to be set at 0.63 for 30-
day periods of care based on our simulations looking at both 60-day 
episodes that would span into CY 2020 and 30-day periods. We note that 
in the final rule, we will update our estimate of outlier payments as a 
percent of total HH PPS payments using the most current and complete 
year of HH PPS data (CY 2018 claims data as of June 30, 2019 or later) 
and therefore, we may adjust the final FDL ratio accordingly. We invite 
public comments on the proposed change to the FDL ratio for CY 2020.

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

1. Background
    In the current HH PPS, there is a split-percentage payment approach 
to the 60-day episode of care. The first bill, a Request for 
Anticipated Payment (RAP), is submitted at the beginning of the initial 
episode for 60 percent of the anticipated final claim payment amount. 
The second, final bill is submitted at the end of the 60-day episode 
for the remaining 40 percent. For all subsequent episodes for 
beneficiaries who receive continuous home health care, the episodes are 
paid at a 50/50 percentage payment split. RAP submissions are 
operationally significant, as the RAP establishes the beneficiary's 
primary HHA by alerting the claims processing system consolidating 
billing edits.
    In the CY 2018 HH PPS proposed rule (82 FR 35270), we solicited 
comments as to whether the split-percentage payment approach would 
still be needed for HHAs to maintain adequate cash flow if the unit of 
payment changes from a 60-day episode to a 30-day period; ways to 
phase-out the split-percentage payment approach, including reducing the 
percentage of

[[Page 34637]]

upfront payment incrementally over a period of time; and if the split-
percentage payment approach was ultimately eliminated, whether 
submission of a Notice of Admission (NOA) within 5 days of the start of 
care would be needed to establish the primary HHA so the claims 
processing system would be alerted to a home health period of care. 
Commenters generally expressed support for continuing the split-
percentage payment approach in the future under the proposed 
alternative case-mix model. While we solicited comments on the 
possibility of phasing-out the split-percentage payment approach in the 
future and the need for a NOA, commenters did not provide suggestions 
for a phase-out approach, but stated that they did not agree with 
requiring a NOA, given their experience with a similar process under 
the Medicare hospice benefit. We did not finalize the change to a 30-
day unit of payment in the CY 2018 HH PPS final rule to allow CMS more 
time to examine the effects of such change to a 30-day unit of payment 
and to an alternate case-mix methodology.
    Section 1895(b)(2)(B) of the Act, as added by section 51001(a) of 
the BBA of 2018, requires that CMS move to a 30-day payment period from 
a 60-day payment period, effective January 1, 2020. As such, in the CY 
2019 HH PPS proposed rule (83 FR 32391), we proposed a change to the 
split-percentage payment approach where newly-enrolled HHAs, meaning 
HHAs that were certified for participation in Medicare on or after 
January 1, 2019, would not receive split-percentage payments beginning 
in CY 2020. We also proposed that HHAs that are certified for 
participation in Medicare effective on or after January 1, 2019, would 
still be required to submit a ``no pay'' RAP at the beginning of care 
in order to establish the home health period of care, as well as every 
30 days thereafter. Additionally, we proposed that existing HHAs, that 
is, HHAs certified for participation in Medicare effective prior to 
January 1, 2019, would continue to receive split-percentage payments 
upon implementation of the PDGM and the 30-day unit of payment in CY 
2020. For split-percentage payments to be made, we proposed that 
existing HHAs would have to submit a RAP at the beginning of each 30-
day period of care and a final claim would be submitted at the end of 
each 30-day period of care. For the first 30-day period of care, we 
proposed that the split-percentage payment would be 60/40 and all 
subsequent 30-day periods of care would be a split-percentage payment 
of 50/50.
    Many commenters supported all or parts of the split-percentage 
payment proposals. Some commenters stated that elimination of the 
split-percentage payments would align better with a 30-day payment and 
would simplify home health claims submissions. Other commenters 
generally expressed support for continuing the split-percentage payment 
approach under the PDGM and disagreed with any future phase-out because 
of a potential impact on cash flow. Others supported eventual 
elimination of split-percentage payments but wanted ample time to adapt 
to the PDGM and suggested a multi-year phase-out approach. Some 
commenters supported elimination of split-percentage payments for late 
periods of care but suggested that the split-percentage payments should 
continue for early periods to ensure an upfront payment for newly 
admitted home health patients. Ultimately, we finalized all of the 
split-percentage payments proposals in the CY 2019 HH PPS final rule 
(83 FR 56463), discussed previously.
2. CY 2019 HH PPS Final Rule Title Error Correction
    In the CY 2019 HH PPS final rule with comment (83 FR 56628), we 
finalized that newly-enrolled HHAs, that is HHAs certified for 
participation in Medicare effective on or after January 1, 2019, will 
not receive split-percentage payments beginning in CY 2020. HHAs that 
are certified for participation in Medicare effective on or after 
January 1, 2019, will still be required to submit a ``no pay'' Request 
for Anticipated Payment (RAP) at the beginning of a period of care in 
order to establish the home health period of care, as well as every 30 
days thereafter. Existing HHAs, meaning those HHAs that are certified 
for participation in Medicare with effective dates prior to January 1, 
2019, would continue to receive split-percentage payments upon 
implementation of the PDGM and the change to a 30-day unit of payment 
in CY 2020. We finalized the corresponding regulations text changes at 
Sec.  484.205(g)(2), which sets forth the policy for split-percentage 
payments for periods of care on or after January 1, 2020.
    However, after the final rule was published, we note that there was 
an error in titling when the CY 2019 HH PPS final rule went to the 
Federal Register. Specifically, paragraph (g)(2)(ii) is incorrectly 
titled ``Split percentage payments on or after January 1, 2019''. The 
title of this paragraph implies that split percentage payments are made 
to newly-enrolled HHAs on or after January 1, 2019, which is 
contradictory to the finalized policy on split percentage-payments for 
newly enrolled HHAs beginning in CY 2020. As such, we are proposing to 
make a correction to the regulations text at Sec.  484.205(g)(2)(iii) 
to accurately reflect the finalized policy that newly-enrolled HHAs 
will not receive split-percentage payments beginning in CY 2020. The 
regulation at Sec.  484.205(g)(2)(iii), as it relates to split 
percentage payments for newly-enrolled HHAs under the HH PPS beginning 
in CY 2020, is separate from the placement of new HHAs into a 
provisional period of enhanced oversight under the authority of section 
6401(a)(3) of the Affordable Care Act, which amended section 1866(j)(3) 
of the Act. The provisional period of enhanced oversight became 
effective in February 2019. More information regarding the provisional 
period of enhanced oversight can be found at the following link: 
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19005.pdf
3. CY 2020 and Subsequent Years
    CMS continues to believe that, as a result of a reduced timeframe 
for the unit of payment from a 60-day episode of care to a 30-day 
period of care, a split-percentage payment approach may not be needed 
for HHAs to maintain an adequate cash flow. We also believe that a one-
time submission of a NOA followed by home health claims submission on a 
30-day basis may streamline claims processing for HHAs. Additionally, 
our analysis has shown that approximately 5 percent of RAPs are not 
submitted until the end of a 60-day episode of care, 10 percent of RAPs 
are not submitted until 36 days after the start of the 60-day episode 
of care, and the median length of days for RAP submission is 12 days 
from the start of the 60-day episode of care (82 FR 35307). We believe 
that these data are inconsistent with the stated justification for RAPs 
maintaining adequate cash flow, especially given the change from a 60- 
to 30-day unit of payment, and increases complexity for HHAs in their 
claim submission processing. With the change to monthly billing in CY 
2020, HHAs should have the ability to maintain an ongoing cash flow, 
which we believe mitigates concerns for the continued need of a split-
percentage payment.
    We did not finalize any changes to RAP payments for existing HHAs 
in the CY 2019 HH PPS final rule (83 FR 56462), we stated that we would 
monitor RAP submissions, service

[[Page 34638]]

utilization, payment and quality trends which may change as a result of 
implementing the PDGM and a 30-day unit of payment. We also stated if 
changes in practice and/or coding patterns or RAPs submissions arise, 
we may propose additional changes in policy.
    We have observed that RAP payments pose a significant program 
integrity risk to the Medicare program, as the current RAP structure 
pays HHAs 50 to 60 percent of the total episode payment upfront. 
Currently, RAP payments are automatically recouped against other 
payments if the claim for a given episode does not follow the RAP 
submission in the later of: (1) 120 days from the start of the episode; 
or (2) 60 days from the payment date of the RAP. As stated in the CY 
2019 HH PPS proposed rule (83 FR 32391), some fraud schemes have 
involved HHAs collecting RAP payments, never submitting final claims, 
and ceasing business before CMS is aware of the need to take action.
    Under a typical RAP fraud scenario, a large amount of RAPs are 
submitted in a short period of time, which could potentially result in 
payments of millions of dollars within days of the submissions. The 60-
day or 120-day time period before a RAP cancellation is triggered in 
the Fiscal Intermediary Standard System (FISS) is long enough to allow 
a provider to continue to submit RAPs before we can identify that the 
final claims are not being submitted and services are not being 
rendered, and yet is too short for us to perform the necessary 
investigative steps, such as medical reviews, site verifications, and 
beneficiary interviews, to determine if fraudulent actions have been 
conducted. The current payment regulations also allow discharges and 
readmissions during a home health payment episode, which means that 
some HHAs can submit multiple RAPs for the same provider/patient 
combination during the same episode of care.
    This type of fraud scheme has been most prevalent among existing 
providers. As a variation on this scheme, individuals with the intent 
of perpetuating this fraud enter the Medicare program by acquiring 
existing HHAs, allowing them to circumvent Medicare's screening and 
enrollment process. For example, during the screening process, we deny 
enrollment if owners listed on the enrollment form have certain 
criminal backgrounds. However, some providers who acquire HHAs fail to 
disclose ownership changes and as a result, the newly purchased HHA is 
not subject to the normal enrollment screening process leaving us blind 
to potentially problematic criminal histories. There are cases where we 
would have denied enrollment based on a new owner's prior criminal 
background, but we approve the enrollment of the purchasing entity due 
to the intentional omission of the new owner and his criminal history. 
More specifically, individuals intent on perpetrating the HH RAP fraud 
have taken advantage of the acquisition of existing agencies through 
Changes of Ownership (CHOWs) and Changes of Information, failing to 
disclose ownership changes for those HH entities to CMS. A CHOW results 
in the transfer of a previous owner's Medicare Identification Number 
and provider agreement (including the previous owner's outstanding 
Medicare debts) to a new owner and must be reported within 30 days. A 
Change of Information must be submitted for various types of changes of 
information on an enrollment. For instance, a change in ownership other 
than a CHOW--such as the sale of stock from one of several 5 percent or 
more owners, who is no longer an owner, to a new individual who has 
become a 5 percent or more owner--also must be reported within 30 days 
of the change (see Sec.  424.516(e)). Based on our investigations, 
individuals perpetrating the RAP fraud fail to disclose ownership or 
informational changes, which results in the changes not being reflected 
in the Provider Enrollment, Chain, and Ownership System (PECOS), the 
online Medicare provider and suppler enrollment system that allows 
registered users to securely and electronically submit and manage 
Medicare enrollment information. The lack of information concerning 
changes in ownership contributes to the perpetuation of HH RAP fraud.
    CMS has monitored numerous schemes like this where an existing HHA 
undergoes an unreported ownership change and CMS identifies a massive 
spike in RAP submissions with no final claims ever being submitted. 
These types of RAP fraud cases are difficult to investigate because the 
actual owners perpetrating the fraud are often not the owners 
identified in PECOS due to a failure to disclose ownership changes. 
This complicates investigations and results in the need for additional 
resources to perform extensive manual research of Secretary of States' 
(SOS) and licensing agencies' websites. In several cases, the 
individuals perpetrating the fraud have been found to be located 
outside the country.
    The following are examples of HHAs that were identified for billing 
large amounts of RAPs after a CHOW, or the acquisition of an existing 
agency, from 2014 to the present.
     Example 1: One prior investigation illustrates an 
individual intent on perpetrating the HH RAP fraud who took advantage 
of the acquisition of an existing agency. The investigation was 
initiated based on a lead generated by the Fraud Prevention System 
(FPS). Per PECOS, the provider had an effective date that was followed 
by a CHOW. The investigation was aided by a whistleblower coming 
forward who stated that the new owners of the agency completed the 
transaction with the intent to submit large quantities of fraudulent 
claims with the expressed purpose of receiving inappropriate payment 
from Medicare. Notwithstanding the quick actions taken to prevent 
further inappropriate payments, the fraud scheme resulted in improper 
payments of RAPs and final claims in the amount of $1.3 million.
     Example 2: One investigation, CY 2019 HH PPS proposed rule 
(83 FR 32391), involved a HHA located in Michigan that submitted home 
health claims for beneficiaries located in California and Florida. 
Further analysis found that after a CHOW the HHA submitted RAPs with no 
final claims. CMS discovered that the address of record for the HHA was 
vacant for an extended period of time. In addition, we determined that 
although the HHA had continued billing and receiving payments for RAP 
claims, it had not submitted a final claim in 10 months. Ultimately, 
the HHA submitted a total of $50,234,430 in RAP claims and received 
$37,204,558 in RAP payments.
     Example 3: A HHA submitted a significant spike in the 
number of RAPs following an ownership change. The investigation 
identified that in the period following the CHOW there were RAP 
payments totaling $12 million and thousands of RAPs that were submitted 
for which apparently no services were rendered.
     Example 4: An Illinois HHA was identified through analysis 
of CHOW information. Three months after, the HHA had a CHOW, the 
provider submitted a spike in RAP suppressions. All payments to the 
provider were suspended. Notwithstanding, the provider was paid $3.6 
million in RAPs.
    We have attempted to address these types of vulnerabilities through 
extensive monitoring and investigations. However, there continues to be 
cases of individual HHAs causing large RAP fraud losses.
    In the CY 2019 HH PPS final rule (83 FR 56462), we stated our plan 
to continue to closely monitor RAP submissions, service utilization,

[[Page 34639]]

payment, and quality trends which may change as a result of 
implementing of the PDGM and a 30-day unit of payment in order to 
address unusual billing patterns and potential fraud related to RAP 
payments to existing providers. In light of the issues outlined in this 
section, we have determined that the program integrity concerns based 
upon the current RAP structure are significant enough to revisit the 
continued need for RAP payments for existing HHAs and propose a phase-
out approach to RAP payments.
    Therefore, we are proposing a reduction of the split-percentage 
payment in CY 2020 for existing HHAs and elimination of split-
percentage payments for all providers in CY 2021, along with 
corresponding regulations text changes at Sec.  484.205. Specifically, 
we are proposing, for existing HHAs (that is, HHAs certified for 
participation in Medicare with effective dates prior to January 1, 
2019): (1) To reduce the split-percentage payment from the current 60/
50 percent (dependent on whether the RAP is for a new or subsequent 
period of care) to 20 percent in CY 2020 for all 30-day HH periods of 
care (both initial and subsequent periods of care); and (2) full 
elimination of the split-percentage payments for all providers in CY 
2021. We believe that the proposed phase-out approach of split-
percentage payments with a reduction to a 20 percent split-percentage 
payment in CY 2020 allows HHAs time to adjust to a no-RAP environment 
and provides sufficient time for software and business process changes 
for a CY 2021 implementation. The current split-percentage payments are 
60/40 (for initial episodes of care) and 50/50 (for subsequent episodes 
of care); therefore, we believe that the reduction in the split-
percentage payment must be sufficient enough in order to mitigate the 
perpetuation of fraud schemes. As such, we believe a reduction to the 
split percentage payment to 20 percent would achieve this purpose. 
However, the 20 percent split percentage payment would still provide 
some upfront payment as HHAs transition from receiving split-percentage 
payments to receiving full payments on a 30-day basis.
    Additionally, we are proposing that newly enrolled HHAs, that is, 
HHAs enrolled in Medicare on or after January 1, 2019 (and would not 
receive split-percentage payments beginning in CY 2020), would continue 
to submit ``no-pay'' RAPs at the beginning of every 30-day period in CY 
2020. Beginning in CY 2021, we are proposing that all HHAs would 
receive the full 30-day period of care payment once the final claim is 
submitted to CMS.
    Beginning in CY 2021, we are also proposing that all HHAs submit a 
one-time submission of a NOA within 5 calendar days of the start of 
care to establish that the beneficiary is under a Medicare home health 
period of care. The NOA would be used to trigger HH consolidated 
billing edits, required by law under section 1842(b)(6)(F) of the Act, 
and would allow for other providers and the CMS claims processing 
systems to know that the beneficiary is in a HH period of care. We are 
proposing that the NOA be submitted only at the beginning of the first 
30-day period of care (that is, the NOA would not have to be submitted 
for each subsequent 30-day period of care) to establish that the 
beneficiary is under a home health period of care. However, if there is 
any beneficiary discharge from home health services and subsequent 
readmission, a new NOA would need to be submitted within 5 calendar 
days of an initial 30-day period of care.
    When we solicited comments in the CY 2019 HH PPS proposed rule (83 
FR 32390) on requiring HHAs to submit a NOA within 5 days of the start 
of care if the split-percentage payment approach was eliminated, 
commenters stated that they did not agree with requiring a NOA given 
the experience with a similar Notice of Election (NOE) process under 
the Medicare hospice benefit where there were submission issues causing 
untimely filed NOEs. However, implementation of the Electronic Data 
Interchange (EDI) submission of hospice Notices of Election (NOE) in 
January 2018 has alleviated the issues related to the submission of the 
hospice NOE by increasing efficiency and information exchange 
coordination. As such, we are proposing that the home health NOA 
process would be through an EDI submission, similar to that used for 
submission of the hospice NOE. An EDI submission occurs when NOEs or 
NOAs are submitted through an electronic data interchange for the 
purpose of minimizing data entry errors. Because there is already a 
Medicare claims processing notification of a benefit admission process 
in place, we believe that this should make the home health NOA process 
more consistent and timely for HHAs.
    Furthermore, because of the reduced timeframe for the unit of 
payment from a 60-day episode of care to a 30-day period of care and 
the proposed elimination of RAPs, NOAs would be needed for home health 
period of care identification (83 FR 32390). Without such notification 
triggering the home health consolidated billing edits establishing the 
home health period of care in the common working file (CWF), there 
could be an increase in claims denials. Subsequently, this potentially 
could result in an increase in appeals and an increase in situations 
where other providers, including other HHAs, would not have easily 
accessible information on whether a patient was already being treated 
by another HHA. In the CY 2019 HH PPS final rule, while some commenters 
expressed their concern about potential submission issues and claims 
delays which could result from the potential use of a NOA, one national 
association was in support of such proposal. The association strongly 
recommended CMS require HHAs to submit a NOA within 5 calendar days 
from the start of care to ensure that the proper agency is established 
as the primary HHA for the beneficiary and so that the claims 
processing system is alerted that a beneficiary is under an HHA period 
of care to enforce the consolidated billing edits required by law.
    We are proposing that failure to submit a timely NOA would result 
in a reduction to the 30-day Medicare payment amount, from the start of 
care date to the NOA filing date, as is done similarly in hospice. As 
hospice is paid a bundled per diem payment amount for each day a 
beneficiary is under a hospice election, Medicare will not cover and 
pay for the days of hospice care from the hospice admission date to the 
date the NOE is submitted to the Medicare contractor. Therefore, we are 
proposing that the penalty for not submitting a timely home health NOA 
would result in Medicare not paying for those days of home health 
services from the start of care date to the NOA filing date.
    Since payment under home health is a bundled payment, which 
includes a national, standardized 30-day period payment rate adjusted 
for case-mix and geographic wage differences, we are proposing that the 
payment reduction would be applied to the case-mix and wage-adjusted 
30-day period payment amount, including NRS. As such, we are proposing 
that the penalty for not submitting a timely NOA would be a 1/30 
reduction off of the full 30-day period payment amount for each day 
until the date the NOA is submitted (that is, from the start of care 
date through the day before the NOA is submitted, as the day of 
submission would be a covered day). The reduction (R) to the full 30-
day period payment amount would be calculated as follows:

[[Page 34640]]

     The number of days (d) from the start of care until the 
NOA is submitted divided by 30 days;
     The fraction from step 1 is multiplied by the case-mix and 
wage adjusted 30-day period payment amount (P).
    The formula for the reduction would be R = (d/30) x P.

There would be no NOA penalty if the NOA is submitted timely (that is, 
within the first 5 calendar days starting with the start of care date). 
Likewise, we propose that for periods of care in which an HHA fails to 
submit a timely NOA, no LUPA payments would be made for days that fall 
within the period of care prior to the submission of the NOA. We are 
proposing that these days would be a provider liability, the payment 
reduction could not exceed the total payment of the claim, and that the 
provider may not bill the beneficiary for these days. Once the NOA is 
received, all claims for both initial and subsequent episodes of care 
would compare the receipt date of the NOA to the HH period of care 
start date to determine whether a late NOA reduction applies.
    However, we are also proposing that if an exceptional circumstance 
is experienced by the HHA, CMS may waive the consequences of failure to 
submit a timely-filed NOA. For instance, if a HHA requests a waiver of 
the payment consequences due to an exceptional circumstance, the home 
health agency would fully document and furnish any requested 
documentation to CMS, through their corresponding MAC, for a 
determination of exception. We are proposing that these exceptional 
circumstances would be the same as those in place for the hospice NOE. 
That is, we are proposing that an exceptional circumstance for such 
waiver would be, but is not limited to the following:
     Fires, floods, earthquakes, or similar unusual events that 
inflict extensive damage to the home health agency's ability to 
operate.
     A CMS or Medicare contractor systems issue that is beyond 
the control of the home health agency.
     A newly Medicare-certified home health agency that is 
notified of that certification after the Medicare certification date, 
or which is awaiting its user ID from its Medicare contractor.
     Other situations determined by CMS to not be under the 
control of the home health agency.
    We are soliciting comments on our proposals to phase-out the split 
percentage payments beginning in CY 2020 with the elimination of split-
percentage payments in CY 2021 for existing HHAs (that is, those HHAs 
certified to participate in Medicare prior to January 1, 2019). We note 
that in the CY 2019 HH PPS final rule (83 FR 56463), we finalized that 
HHAs certified for participation in Medicare on and after January 1, 
2019, would not receive split percentage payments beginning in CY 2020. 
We are also soliciting comments on the implementation of a NOA process, 
including the NOA timely-filing requirement, for all HHAs, in CY 2021 
and subsequent years; and the corresponding regulation text changes at 
Sec.  484.205.

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

    As referenced in our regulations at Sec.  409.44(c)(2)(iii), in 
order for therapy visits to be covered in the home health setting one 
of three criteria must be met: There must be an expectation that the 
beneficiary's condition will improve materially in a reasonable (and 
generally predictable) period of time based on the physician's 
assessment of the beneficiary's restoration potential and unique 
medical condition; the unique clinical condition of a patient requires 
the specialized skills, knowledge, and judgment of a qualified 
therapist to design or establish a safe and effective maintenance 
program required in connection with the patient's specific illness or 
injury; or the unique clinical condition of a patient requires the 
specialized skills of a qualified therapist to perform a safe and 
effective maintenance program required in connection with the patient's 
specific illness or injury. The regulations at Sec.  
409.44(c)(2)(iii)(C) state that where the clinical condition of the 
patient is such that the complexity of the therapy services required to 
maintain function involves the use of complex and sophisticated therapy 
procedures to be delivered by the therapist himself/herself (and not an 
assistant) or the clinical condition of the patient is such that the 
complexity of the therapy services required to maintain function must 
be delivered by the therapist himself/herself (and not an assistant) in 
order to ensure the patient's safety and to provide an effective 
maintenance program, then those reasonable and necessary services shall 
be covered.
    In contrast to restorative therapy, provided when the goals of care 
are geared towards patient improvement, maintenance therapy is provided 
when improvement is not feasible in order to prevent or slow further 
decline/deterioration of the patient's condition. While a therapist 
assistant is able to perform restorative therapy under the Medicare 
home health benefit, the regulations at Sec.  409.44(c)(2)(iii)(C) 
state that only a qualified therapist, and not an assistant, can 
perform maintenance therapy. Of note, the CY 2011 HH PPS final rule (75 
FR 70372) reorganized the text regarding this regulation, but did not 
re-evaluate the policy.
    The regulations at Sec.  484.115(g) and (i) state that qualified 
occupational and physical therapist assistants are licensed as 
assistants unless licensure does not apply, are registered or 
certified, if applicable, as assistants by the state in which 
practicing, and have graduated from an approved curriculum for 
therapist assistants, and passed a national examination for therapist 
assistants. In states where licensure does not apply, therapist 
assistants must meet certain education and/or proficiency examination 
requirements. For example, physical therapist assistants (PTAs) in 
general, practice in accordance with physical therapy state practice 
acts, providing many of the services that a physical therapist (PT) 
provides, such as therapeutic exercise, mobilization, and passive 
manipulation.\15\ Services must be commensurate with the PTA's 
education, training, and experience, and must be under the direction of 
a supervising PT. Additionally, Medicare allows services furnished by 
therapist assistants to be included as part of the covered services 
under a benefit when provided under the direction and supervision of a 
qualified therapist.\16\ The regulations at Sec.  409.44(c) set out the 
skilled service requirements for physical therapy, speech-language 
pathology services, and occupational therapy under the home health 
benefit. In accordance with Sec.  409.44(c)(1)(i), a patient must be 
under a physician plan of care with documented therapy goals 
established by a qualified therapist in conjunction with the physician. 
Additionally, in accordance with Sec.  409.44(c)(2)(i)(A) and (B), the 
patient's function must be initially assessed and reassessed at least 
every 30 calendar days by a qualified therapist. As such, under the 
Medicare home health benefit, a therapist assistant can furnish 
services covered under a home health plan of care, when provided under 
the direction and supervision of a qualified therapist, responsible for 
establishing the plan of care and assessing and reassessing the 
patient.
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    \15\ https://www.laptboard.org/index.cfm/rules/practiceact.
    \16\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.

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[[Page 34641]]

    While Medicare allows for skilled maintenance therapy in a SNF, HH, 
and other outpatient settings, the type of clinician that can provide 
the therapy services vary by setting. In some settings both the 
therapist and the therapist assistant can deliver the skilled 
maintenance therapy services, and in other settings, only the therapist 
can deliver the skilled maintenance therapy services. For example, 
Medicare regulations allow therapist assistants to provide maintenance 
therapy in a SNF, but not in the home health setting. Furthermore, 
commenters on the CY 2019 Physician Fee Schedule final rule (83 FR 
59654) noted concerns about shortages of therapists and finalized 
payment for outpatient therapy services for which payment is made for 
services that are furnished by a therapist assistant. As such, this 
rule recognizes that therapist assistants play a valuable role in the 
provision of needed therapy services.
    We believe it would be appropriate to allow therapist assistants to 
perform maintenance therapy services under a maintenance program 
established by a qualified therapist under the home health benefit, if 
acting within the therapy scope of practice defined by state licensure 
laws. The qualified therapist would still be responsible for the 
initial assessment; plan of care; maintenance program development and 
modifications; and reassessment every 30 days, in addition to 
supervising the services provided by the therapist assistant. We 
believe this would allow home health agencies more latitude in resource 
utilization. Furthermore, allowing assistants to perform maintenance 
therapy would be consistent with other post-acute care settings, 
including SNFs. Thus, we are proposing to modify the regulations at 
Sec.  409.44(c)(2)(iii)(C) to allow therapist assistants (rather than 
only therapists) to perform maintenance therapy under the Medicare home 
health benefit. We are soliciting comments regarding this proposal and 
we also welcome feedback on whether this proposal would require 
therapists to provide more frequent patient reassessment or maintenance 
program review when the services are being performed by a therapist 
assistant. We are also soliciting comments on whether we should revise 
the description of the therapy codes to indicate maintenance services 
performed by a physical or occupational therapist assistant (G0151 and 
G0157) versus a qualified therapist, or simply remove the therapy code 
indicating the establishment or delivery of a safe and effective 
physical therapy maintenance program, by a physical therapist (G0159). 
We welcome comments on the importance of tracking whether a visit is 
for maintenance or restorative therapy or whether it would be 
appropriate to only identify whether the service is furnished by a 
qualified therapist or an assistant. Finally, we seek comments on any 
possible effects on the quality of care that could result by allowing 
therapist assistants to perform maintenance therapy.

I. Proposed Changes to the Home Health Plan of Care Regulations at 
Sec.  409.43

    As a condition for payment of Medicare home health services, the 
regulations at Sec.  409.43(a), home health plan of care content 
requirements, state that the plan of care must contain those items 
listed in Sec.  484.60(a) that specify the standards relating to a plan 
of care that an HHA must meet in order to participate in the Medicare 
program. The home health conditions of participation (CoPs) at Sec.  
484.60(a) set forth the content requirements of the individualized home 
health plan of care. In the January 13, 2017 final rule, ``Medicare and 
Medicaid Program: Conditions of Participation for Home Health 
Agencies'' (82 FR 4504), we finalized changes to the plan of care 
requirements under the home health CoPs by reorganizing the existing 
plan of care content requirements at Sec.  484.18(a), adding two 
additional plan of care content requirements, and moving the plan of 
care content requirements to Sec.  484.60(a). Specifically, in addition 
to the longstanding plan of care content requirements previously listed 
at Sec.  484.18(a), a home health plan of care must also include the 
following:
     A description of the patient's risk for emergency 
department visits and hospital readmission, and all necessary 
interventions to address the underlying risk factors; and
     Information related to any advanced directives.
    The new content requirements for the plan of care at Sec.  
484.60(a) became effective January 13, 2018 (82 FR 31729) and the 
Interpretive Guidelines to accompany the new CoPs were released on 
August 31, 2018. Since implementation of the new home health CoP plan 
of care requirements, we clarified in subregulatory guidance in the 
Medicare Benefit Policy Manual, chapter 7,\17\ that the plan of care 
must include the identification of the responsible discipline(s) 
providing home health services, and the frequency and duration of all 
visits, as well as those items required by the CoPs that establish the 
need for such services (Sec.  484.60(a)(2)(iii) and (iv)).
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    \17\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
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    However, the current requirements at Sec.  409.43(a) may be overly 
prescriptive and may interfere with timely payment for otherwise 
eligible episodes of care. To mitigate these potential issues, we are 
proposing to change the regulations text at Sec.  409.43(a). 
Specifically, we are proposing to change the regulations text to state 
that for HHA services to be covered, the individualized plan of care 
must specify the services necessary to meet the patient-specific needs 
identified in the comprehensive assessment. In addition, the plan of 
care must include the identification of the responsible discipline(s) 
and the frequency and duration of all visits as well as those items 
listed in 42 CFR 484.60(a) that establish the need for such services. 
All care provided must be in accordance with the plan of care. While 
these newly-added plan of care items at Sec.  484.60(a) remain CoP, we 
believe that violations for missing required items are best addressed 
through the survey process, rather than through claims denials for 
otherwise eligible periods of care. We are soliciting comments on this 
proposal to change to the regulations text at Sec.  409.43 to state 
that the home health plan of care must include those items listed in 42 
CFR 484.60(a) that establish the need for such services.

IV. Proposed Provisions of the Home Health Value-Based Purchasing 
(HHVBP) Model

A. Background

    As authorized by section 1115A of the Act and finalized in the CY 
2016 HH PPS final rule (80 FR 68624) and in the regulations at 42 CFR 
part 484, subpart F, we began testing the HHVBP Model on January 1, 
2016. The HHVBP Model has an overall purpose of improving the quality 
and delivery of home health care services to Medicare beneficiaries. 
The specific goals of the Model are to: (1) Provide incentives for 
better quality care with greater efficiency; (2) study new potential 
quality and efficiency measures for appropriateness in the home health 
setting; and (3) enhance the current public reporting process.
    Using the randomized selection methodology finalized in the CY 2016 
HH PPS final rule, we selected nine states for inclusion in the HHVBP 
Model, representing each geographic area across the nation. All 
Medicare-certified Home Health Agencies (HHAs) providing services in 
Arizona, Florida,

[[Page 34642]]

Iowa, Maryland, Massachusetts, Nebraska, North Carolina, Tennessee, and 
Washington are required to compete in the Model. The HHVBP Model uses 
the waiver authority under section 1115A(d)(1) of the Act to adjust 
Medicare payment rates under section 1895(b) of the Act based on the 
competing HHAs' performance on applicable measures. The maximum payment 
adjustment percentage increases incrementally, upward or downward, over 
the course of the HHVBP Model in the following manner: (1) 3 percent in 
CY 2018; (2) 5 percent in CY 2019; (3) 6 percent in CY 2020; (4) 7 
percent in CY 2021; and (5) 8 percent in CY 2022. Payment adjustments 
are based on each HHA's Total Performance Score (TPS) in a given 
performance year (PY), which is comprised of performance on: (1) A set 
of measures already reported via the Outcome and Assessment Information 
Set (OASIS), completed Home Health Consumer Assessment of Healthcare 
Providers and Systems (HHCAHPS) surveys, and select claims data 
elements; and (2) three New Measures for which points are achieved for 
reporting data.
    In the CY 2017 HH PPS final rule (81 FR 76741 through 76752), CY 
2018 HH PPS final rule (83 FR 51701 through 51706), and CY 2019 HH PPS 
final rule (83 FR 56527 through 56547), we finalized changes to the 
HHVBP Model. Some of those changes included adding and removing 
measures from the applicable measure set, revising our methodology for 
calculating benchmarks and achievement thresholds at the state level, 
creating an appeals process for recalculation requests, and revising 
our methodologies for weighting measures and assigning improvement 
points.

B. Public Reporting of Total Performance Scores and Percentile Rankings 
Under the HHVBP Model

    As stated previously and discussed in prior rulemaking, one of the 
goals of the HHVBP Model is to enhance the current public reporting 
processes for home health. In the CY 2016 HH PPS final rule, we 
finalized our proposed reporting framework for the HHVBP Model, 
including both the annual and quarterly reports that are made available 
to competing HHAs and a separate, publicly available quality report (80 
FR 68663 through 68665). We stated that such publicly available 
performance reports would inform home health industry stakeholders 
(consumers, physicians, hospitals) as well as all competing HHAs 
delivering care to Medicare beneficiaries within selected state 
boundaries on their level of quality relative to both their peers and 
their own past performance, and would also provide an opportunity to 
confirm that the beneficiaries referred for home health services are 
being provided the best quality of care available. We further stated 
that we intended to make public competing HHAs' TPSs with the intention 
of encouraging providers and other stakeholders to utilize quality 
ranking when selecting an HHA. As summarized in the CY 2016 final rule 
(80 FR 68665), overall, commenters generally encouraged the 
transparency of data pertaining to the HHVBP Model. Commenters offered 
that to the extent possible, accurate comparable data would provide 
HHAs the ability to improve care delivery and patient outcomes, while 
better predicting and managing quality performance and payment updates.
    We have continued to discuss and solicit comments on the scope of 
public reporting under the HHVBP Model in subsequent rulemaking. In the 
CY 2017 final rule (81 FR 76751 through 76752), we discussed the public 
display of total performance scores, stating that annual publicly 
available performance reports would be a means of developing greater 
transparency of Medicare data on quality and aligning the competitive 
forces within the market to deliver care based on value over volume. We 
stated our belief that the public reporting of competing HHAs' 
performance scores under the HHVBP Model would support our continued 
efforts to empower consumers by providing more information to help them 
make health care decisions, while also encouraging providers to strive 
for higher levels of quality. We explained that we have employed a 
variety of means (CMS Open Door Forums, webinars, a dedicated help 
desk, and a web-based forum where training and learning resources are 
regularly posted) to facilitate direct communication, sharing of 
information and collaboration to ensure that we maintain transparency 
while developing and implementing the HHVBP Model. This same care was 
taken with our plans to publicly report performance data, through 
collaboration with other CMS components that use many of the same 
quality measures. We also noted that section 1895(b)(3)(B)(v) of the 
Act requires HHAs to submit patient-level quality of care data using 
the OASIS and the HHCAHPS, and that section 1895(b)(3)(B)(v)(III) of 
the Act states that this quality data is to be made available to the 
public. Thus, HHAs have been required to collect OASIS data since 1999 
and report HHCAHPS data since 2012.
    We solicited further public comment in the CY 2019 HH PPS proposed 
rule (83 FR 32438) on which information from the Annual Total 
Performance Score and Payment Adjustment Report (Annual Report) should 
be made publicly available. We noted that HHAs have the opportunity to 
review and appeal their Annual Report as outlined in the appeals 
process finalized in the CY 2017 HH PPS final rule (81 FR 76747 through 
76750). Examples of the information included in the Annual Report are 
the agency name, address, TPS, payment adjustment percentage, 
performance information for each measure used in the Model (for 
example, quality measure scores, achievement, and improvement points), 
state and cohort information, and percentile ranking. We stated that 
based on the public comments received, we would consider what 
information, specifically from the Annual Report, we may consider 
proposing for public reporting in future rulemaking.
    As we summarized in the CY 2019 HH PPS final rule (83 FR 56546 
through 56547), several commenters expressed support for publicly 
reporting information from the Annual Total Performance Score and 
Payment Adjustment Report, as they believed it would better inform 
consumers and allow for more meaningful and objective comparisons among 
HHAs. Other commenters suggested that CMS consider providing the 
percentile ranking for HHAs along with their TPS and expressed interest 
in publicly reporting all information relevant to the HHVBP Model. 
Several commenters expressed concern with publicly displaying HHAs' 
TPSs, citing that the methodology is still evolving and pointing out 
that consumers already have access to data on the quality measures in 
the Model on Home Health Compare. Another commenter believed that 
publicly reporting data just for states included in the HHVBP Model 
could be confusing for consumers.
    Our belief remains that publicly reporting HHVBP data would enhance 
the current home health public reporting processes as it would better 
inform beneficiaries when choosing an HHA, while incentivizing HHAs to 
improve quality. Although the data made public would only pertain to 
the final performance year of the Model, we believe that publicly 
reporting HHVBP data for Performance Year 5 would nonetheless 
incentivize HHAs to improve performance. Consistent with our discussion 
in prior rulemaking of the information that we are considering

[[Page 34643]]

for public reporting under the HHVBP Model, we propose to publicly 
report, on the CMS website the following two points of data from the 
final CY 2020 (PY) 5 Annual Report for each participating HHA in the 
Model that qualified for a payment adjustment for CY 2020: (1) The 
HHA's TPS from PY 5, and (2) the HHA's corresponding PY 5 TPS 
Percentile Ranking. We are considering making these data available on 
the HHVBP Model page of the CMS Innovation website (https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model). These data would be reported for each such competing HHA by 
agency name, city, state, and by the agency's CMS Certification Number 
(CCN). We expect that these data would be made public after December 1, 
2021, the date by which we intend to complete the CY 2020 Annual Report 
appeals process and issuance of the final Annual Report to each HHA.
    As discussed in prior rulemaking, we believe the public reporting 
of such data would further enhance quality reporting under the Model by 
encouraging participating HHAs to provide better quality of care 
through focusing on quality improvement efforts that could potentially 
improve their TPS. In addition, we believe that publicly reporting 
performance data that indicates overall performance may assist 
beneficiaries, physicians, discharge planners, and other referral 
sources in choosing higher-performing HHAs within the nine Model states 
and allow for more meaningful and objective comparisons among HHAs on 
their level of quality relative to their peers.
    We believe that the TPS would be more meaningful if the 
corresponding TPS Percentile Ranking were provided so consumers can 
more easily assess an HHA's relative performance. We would also provide 
definitions for the HHVBP TPS and the TPS Percentile Ranking 
methodology to ensure the public understands the relevance of these 
data points and how they were calculated.
    Under our proposal, the data reported would be limited to one year 
of the Model. We believe this proposal strikes a balance between 
allowing for public reporting under the Model for the reasons discussed 
while heeding commenters' concerns about reporting performance data for 
earlier performance years of the HHVBP Model. We believe publicly 
reporting the TPS and TPS Percentile Ranking for CY 2020 would enhance 
quality reporting under the Model by encouraging participating HHAs to 
provide better quality of care and would promote transparency, and 
could enable beneficiaries to make better informed decisions about 
where to receive care.
    We are soliciting comment on our proposal to publicly report the 
Total Performance Score and Total Performance Score Percentile Ranking 
from the final CY 2020 PY 5 Annual Report for each HHA in the nine 
Model states that qualified for a payment adjustment for CY 2020. We 
are also soliciting comment on our proposed amendment to Sec.  484.315 
to reflect this policy. Specifically, we are proposing to add new 
paragraph (d) to specify that CMS will report, for performance year 5, 
the TPS and the percentile ranking of the TPS for each competing HHA on 
the CMS website.

C. CMS Proposal To Remove Improvement in Pain Interfering With Activity 
Measure (NQF #0177)

    As discussed in section V.C. of this proposed rule, CMS is 
proposing to remove the Improvement in Pain Interfering with Activity 
Measure (NQF #0177) from the Home Health Quality Reporting Program (HH 
QRP) beginning with CY 2022. Under this proposal, HHAs would no longer 
be required to submit OASIS Item M1242, Frequency of Pain Interfering 
with Patient's Activity or Movement, for the purposes of the HH QRP 
beginning January 1, 2021. As HHAs would continue to be required to 
submit their data for this measure through CY 2020, we do not 
anticipate any impact on the collection of this data and the inclusion 
of the measure in the HHVBP Model's applicable measure set for the 
final performance year (CY 2020) of the Model.

V. Proposed Updates to the Home Health Care Quality Reporting Program 
(HH QRP)

A. Background and Statutory Authority

    The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. 
Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and 
subsequent years, each HHA submit to the Secretary in a form and 
manner, and at a time, specified by the Secretary, such data that the 
Secretary determines are appropriate for the measurement of health care 
quality. To the extent that an HHA does not submit data in accordance 
with this clause, the Secretary shall reduce the home health market 
basket percentage increase applicable to the HHA for such year by 2 
percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, 
depending on the market basket percentage increase applicable for a 
particular year, the reduction of that increase by 2 percentage points 
for failure to comply with the requirements of the HH QRP and further 
reduction of the increase by the productivity adjustment (except in 
2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act 
may result in the home health market basket percentage increase being 
less than 0.0 percent for a year, and may result in payment rates under 
the Home Health PPS for a year being less than payment rates for the 
preceding year.
    For more information on the policies we have adopted for the HH 
QRP, we refer readers to the CY 2007 HH PPS final rule (71 FR 65888 
through 65891), the CY 2008 HH PPS final rule (72 FR 49861 through 
49864), the CY 2009 HH PPS update notice (73 FR 65356), the CY 2010 HH 
PPS final rule (74 FR 58096 through 58098), the CY 2011 HH PPS final 
rule (75 FR 70400 through 70407), the CY 2012 HH PPS final rule (76 FR 
68574), the CY 2013 HH PPS final rule (77 FR 67092), the CY 2014 HH PPS 
final rule (78 FR 72297), the CY 2015 HH PPS final rule (79 FR 66073 
through 66074), the CY 2016 HH PPS final rule (80 FR 68690 through 
68695), the CY 2017 HH PPS final rule (81 FR 76752), the CY 2018 HH PPS 
final rule (82 FR 51711 through 51712), and the CY 2019 HH PPS final 
rule (83 FR 56547).

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

    For a detailed discussion of the considerations we historically use 
for measure selection for the HH QRP quality, resource use, and others 
measures, we refer readers to the CY 2016 HH PPS final rule (80 FR 
68695 through 68696). In the CY 2019 HH PPS final rule (83 FR 56548 
through 56550) we also finalized the factors we consider for removing 
previously adopted HH QRP measures.

C. Quality Measures Currently Adopted for the CY 2021 HH QRP

    The HH QRP currently includes 19 \18\ measures for the CY 2021 
program year, as outlined in Table 26.
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    \18\ The HHCAHPS has five component questions that together are 
used to represent one NQF-endorsed measure.

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[[Page 34644]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.069

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

    In line with our Meaningful Measures Initiative, we are proposing 
to remove one measure from the HH QRP beginning with the CY 2022 HH 
QRP.
1. Proposed Removal of the Improvement in Pain Activity Measure (NQF 
#0177)

    We are removing pain-associated quality measures from its quality 
reporting programs in an effort to mitigate any potential unintended, 
over-prescription of opioid medications inadvertently driven by these 
measures. We are proposing to remove the Improvement in Pain 
Interfering with Activity Measure (NQF #0177) from the HH QRP beginning 
with the CY 2022 HH QRP under our measure removal Factor 7: Collection 
or public reporting of a measure leads to negative unintended 
consequences other than patient harm.
    In the CY 2007 HH PPS final rule (71 FR 65888 through 65891), we 
adopted the Improvement in Pain Interfering with Activity Measure 
beginning with the CY 2007 HH QRP. The measure was NQF-endorsed (NQF 
#0177) in March 2009. This risk-adjusted outcome measure reports the 
percentage of HH episodes during which the patient's frequency of pain 
with activity or movement improved. The measure is calculated using 
OASIS Item M1242, Frequency of Pain Interfering with Patient's Activity 
or Movement.\19\
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    \19\ Measure specifications can be found in the Home Health 
Process Measures Table on the Home Health Quality Measures website 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Outcome-Measures-Table-OASIS-D-11-2018c.pdf.
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    We evaluated the Improvement in Pain Interfering with Activity 
Measure (NQF #0177) and determined that the measure could have 
unintended consequences with respect to responsible use of opioids for 
the management of pain. In 2018, CMS published a comprehensive roadmap, 
available at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Opioid-epidemic-roadmap.pdf, which outlined the 
agency's efforts to address national issues around prescription opioid 
misuse and overuse. Because the Medicare program pays for a significant 
amount of prescription opioids, the roadmap was designed to promote 
appropriate stewardship of these medications that can provide a medical 
benefit but also carry a risk for patients, including those receiving 
home health. One key component of this strategy is to prevent new cases 
of opioid use disorder, through education, guidance and monitoring of 
opioid prescriptions. When used correctly, prescription opioids are 
helpful for treating pain. However, effective non-opioid pain 
treatments are available to providers and CMS is working to promote 
their use.
    Although we are not aware of any scientific studies that support an 
association between the prior or current iterations of the Improvement 
in Pain Interfering with Activity Measure (NQF #0177) and opioid 
prescribing practices, out of an abundance of caution and to avoid any 
potential unintended consequences, we are proposing to remove the 
Improvement in Pain Interfering with Activity Measure (NQF #0177) from 
the HH QRP beginning with the CY 2022 HH QRP under measure removal 
Factor 7: Collection or public reporting of a measure leads to negative 
unintended consequences other than patient harm.
    If finalized as proposed, HHAs would no longer be required to 
submit OASIS Item M1242, Frequency of Pain Interfering with Patient's 
Activity or Movement for the purposes of this measure beginning January 
1, 2021. We are unable to remove M1242 earlier due to the timelines 
associated with implementing changes to OASIS. If finalized as 
proposed, data for this

[[Page 34645]]

measure would be publicly reported on HH Compare until April 2020.
    We are inviting public comment on this proposal.

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

    In this proposed rule, we are proposing to adopt two process 
measures for the HH QRP under section 1895(b)(3)(B)(v)(IV)(aa) of the 
Act, both of which would satisfy section 1899B(c)(1)(E)(ii) of the Act, 
which requires that the quality measures specified by the Secretary 
include measures with respect to the quality measure domain titled 
``Accurately communicating the existence of and providing for the 
transfer of health information and care preferences of an individual to 
the individual, family caregiver of the individual, and providers of 
services furnishing items and services to the individual, when the 
individual transitions from a [post-acute care] PAC provider to another 
applicable setting, including a different PAC provider, a hospital, a 
critical access hospital, or the home of the individual.'' Given the 
length of this domain title, hereafter, we will refer to this quality 
measure domain as ``Transfer of Health Information.'' The two measures 
we are proposing to adopt are: (1) Transfer of Health Information to 
Provider-Post-Acute Care; and (2) Transfer of Health Information to 
Patient-Post-Acute Care. Both of these proposed measures support our 
Meaningful Measures priority of promoting effective communication and 
coordination of care, specifically the Meaningful Measure area of the 
transfer of health information and interoperability. One data element 
in the Transfer of Health Information to Patient-Post-Acute Care 
measure evaluates whether information was sent to the patient, family, 
and caregiver at discharge.
    In addition to the two measure proposals, we are proposing to 
update the specifications for the Discharge to Community-Post Acute 
Care (PAC) HH QRP measure to exclude baseline nursing facility (NF) 
residents from the measure.
1. Proposed Transfer of Health Information to the Provider-Post-Acute 
Care (PAC) Measure
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) Measure is a process-based measure that assesses 
whether or not a current reconciled medication list is given to the 
admitting provider when a patient is discharged/transferred from his or 
her current PAC setting.
(a) Background
    In 2013, 22.3 percent of all acute hospital discharges were 
discharged to PAC settings, including 11 percent who were discharged to 
home under the care of a home health agency, and 9 percent who were 
discharged to SNFs.\20\ The proportion of patients being discharged 
from an acute care hospital to a PAC setting was greater among 
beneficiaries enrolled in Medicare fee-for-service (FFS), underscoring 
the importance of the measure. Among Medicare FFS patients discharged 
from an acute hospital, 42 percent went directly to PAC settings. Of 
that 42 percent, 20 percent were discharged to a SNF, 18 percent were 
discharged to an HHA, three percent were discharged to an IRF, and one 
percent were discharged to an LTCH.\21\
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    \20\ Tian, W. ``An all-payer view of hospital discharge to post-
acute care,'' May 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \21\ Ibid.
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    The transfer and/or exchange of health information from one 
provider to another can be done verbally (for example, clinician-to-
clinician communication in-person or by telephone), paper-based (for 
example, faxed or printed copies of records), and via electronic 
communication (for example, through a health information exchange 
network using an electronic health/medical record, and/or secure 
messaging). Health information, such as medication information, that is 
incomplete or missing increases the likelihood of a patient or resident 
safety risk, and is often life-threatening.22 23 24 25 26 27 
Poor communication and coordination across health care settings 
contributes to patient complications, hospital readmissions, emergency 
department visits, and medication 
errors.28 29 30 31 32 33 34 35 36 37 38 39 Communication has 
been cited as the third most frequent root cause in sentinel events, 
which The Joint Commission defines \40\ as a patient safety event that 
results in death, permanent harm, or severe temporary harm. Failed or 
ineffective patient handoffs are estimated to play a role in 20 percent 
of serious preventable adverse events.\41\ When care transitions

[[Page 34646]]

are enhanced through care coordination activities, such as expedited 
patient information flow, these activities can reduce duplication of 
care services and costs of care, resolve conflicting care plans, and 
prevent medical errors.42 43 44 45 46 47
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    \22\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G., 
``Medication reconciliation during transitions of care as a patient 
safety strategy: a systematic review,'' Annals of Internal Medicine, 
2013, Vol. 158(5), pp. 397-403.
    \23\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E., 
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission 
medication reconciliation on adverse drug events from admission 
medication changes,'' Archives of Internal Medicine, 2011, Vol. 
171(9), pp. 860-861.
    \24\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman, 
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital 
admission with unintentional discontinuation of medications for 
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \25\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J., 
``Prescribing errors on admission to hospital and their potential 
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol. 
23(1), pp. 17-25.
    \26\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., & 
Hansen, R.A., ``Medication errors during patient transitions into 
nursing homes: characteristics and association with patient harm,'' 
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6), 
pp. 413-422.
    \27\ Boling, P.A., ``Care transitions and home health care,'' 
Clinical Geriatric Medicine, 2009, Vol. 25(1), pp. 135-48.
    \28\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of 
medication information across settings--keeping it free from 
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \29\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander, 
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless 
of age: incorporating principles from geriatric medicine to improve 
care transitions for patients with complex needs,'' Journal of 
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
    \30\ Jencks, S.F., Williams, M.V., & Coleman, E.A., 
``Rehospitalizations among patients in the Medicare fee-for-service 
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp. 
1418-1428.
    \31\ Institute of Medicine. ``Preventing medication errors: 
quality chasm series,'' Washington, DC: The National Academies Press 
2007. Available at: https://www.nap.edu/read/11623/chapter/1.
    \32\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G., 
``Developing a medication communication framework across continuums 
of care using the Circle of Care Modeling approach,'' BMC Health 
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \33\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The 
revolving door of rehospitalization from skilled nursing 
facilities'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \34\ Institute of Medicine. ``Preventing medication errors: 
quality chasm series,'' Washington, DC: The National Academies Press 
2007. Available at: https://www.nap.edu/read/11623/chapter/1.
    \35\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G., 
``Developing a medication communication framework across continuums 
of care using the Circle of Care Modeling approach,'' BMC Health 
Services Research, 2013, Vol. 13(1), pp. 1-10.
    \36\ Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi, T.K., & 
Bates, D.W., ``The incidence and severity of adverse events 
affecting patients after discharge from the hospital.'' Annals of 
Internal Medicine, 2003, 138(3), pp. 161-167.
    \37\ King, B.J., Gilmore[hyphen]Bykovskyi, A.L., Roiland, R.A., 
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of 
poor communication during transitions from hospital to skilled 
nursing facility: a qualitative study,'' Journal of the American 
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
    \38\ Lattimer, C. (2011). When it comes to transitions in 
patient care, effective communication can make all the difference. 
Generations, 35(1), 69-72.
    \39\ Vognar, L., & Mujahid, N. (2015). Healthcare transitions of 
older adults: an overview for the general practitioner. Rhode Island 
Medical Journal (2013), 98(4), 15-18.
    \40\ The Joint Commission, ``Sentinel Event Policy'' available 
at https://www.jointcommission.org/sentinel_event_policy_and_procedures/.
    \41\ The Joint Commission. ``Sentinel Event Data Root Causes by 
Event Type 2004-2015.'' 2016. Available at: https://www.jointcommission.org/assets/1/23/jconline_Mar_2_2016.pdf.
    \42\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The 
revolving door of rehospitalization from skilled nursing 
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \43\ Institute of Medicine, ``Preventing medication errors: 
quality chasm series,'' Washington, DC: The National Academies 
Press, 2007. Available at: https://www.nap.edu/read/11623/chapter/1.
    \44\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C., 
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner, 
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and 
preventable adverse events among hospitalized children following 
implementation of a resident handoff bundle,'' JAMA, 2013, Vol. 
310(21), pp. 2262-2270.
    \45\ Pronovost, P., M.M.E. Johns, S. Palmer, R.C. Bono, D.B. 
Fridsma, A. Gettinger, J. Goldman, W. Johnson, M. Karney, C. Samitt, 
R.D. Sriram, A. Zenooz, and Y.C. Wang, Editors. Procuring 
Interoperability: Achieving High-Quality, Connected, and Person-
Centered Care. Washington, DC, 2018 National Academy of Medicine. 
Available at: https://nam.edu/wp-content/uploads/2018/10/Procuring-Interoperability_web.pdf.
    \46\ Balaban RB, Weissman JS, Samuel PA, & Woolhandler, S., 
``Redefining and redesigning hospital discharge to enhance patient 
care: a randomized controlled study,'' J Gen Intern Med, 2008, Vol. 
23(8), pp. 1228-33.
    \47\ Siefferman, J.W., Lin, E., & Fine, J.S. (2012). Patient 
safety at handoff in rehabilitation medicine. Physical Medicine and 
Rehabilitation Clinics of North America, 23(2), 241-257.
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    Care transitions across health care settings have been 
characterized as complex, costly, and potentially hazardous, and may 
increase the risk for multiple adverse outcomes.48 49 The 
rising incidence of preventable adverse events, complications, and 
hospital readmissions have drawn attention to the importance of the 
timely transfer of health information and care preferences at the time 
of transition. Failures of care coordination, including poor 
communication of information, were estimated to cost the U.S. health 
care system between $25 billion and $45 billion in wasteful spending in 
2011.\50\ The communication of health information and patient care 
preferences is critical to ensuring safe and effective transitions from 
one health care setting to another.51 52
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    \48\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander, 
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless 
of age: incorporating principles from geriatric medicine to improve 
care transitions for patients with complex needs,'' Journal of 
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
    \49\ Simmons, S., Schnelle, J., Slagle, J., Sathe, N.A., 
Stevenson, D., Carlo, M., & McPheeters, M.L., ``Resident safety 
practices in nursing home settings.'' Technical Brief No. 24 
(Prepared by the Vanderbilt Evidence-based Practice Center under 
Contract No. 290-2015-00003-I.) AHRQ Publication No. 16-EHC022-EF. 
Rockville, MD: Agency for Healthcare Research and Quality. May 2016. 
Available at: https://www.ncbi.nlm.nih.gov/books/NBK384624/.
    \50\ Berwick, D.M. & Hackbarth, A.D. ``Eliminating Waste in US 
Health Care,'' JAMA, 2012, Vol. 307(14), pp.1513-1516.
    \51\ McDonald, K.M., Sundaram, V., Bravata, D.M., Lewis, R., 
Lin, N., Kraft, S.A. & Owens, D.K. Care Coordination. Vol. 7 of: 
Shojania K.G., McDonald K.M., Wachter R.M., Owens D.K., editors. 
``Closing the quality gap: A critical analysis of quality 
improvement strategies.'' Technical Review 9 (Prepared by the 
Stanford University-UCSF Evidence-based Practice Center under 
contract 290-02-0017). AHRQ Publication No. 04(07)-0051-7. 
Rockville, MD: Agency for Healthcare Research and Quality. June 
2006. Available at: https://www.ncbi.nlm.nih.gov/books/NBK44015/.
    \52\ Lattimer, C., ``When it comes to transitions in patient 
care, effective communication can make all the difference,'' 
Generations, 2011, Vol. 35(1), pp. 69-72.
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    Patients in PAC settings often have complicated medication regimens 
and require efficient and effective communication and coordination of 
care between settings, including detailed transfer of medication 
information.53 54 55 Patients in PAC settings may be 
vulnerable to adverse health outcomes due to insufficient medication 
information on the part of their health care providers, and the higher 
likelihood for multiple comorbid chronic conditions, polypharmacy, and 
complicated transitions between care settings.56 57 
Preventable adverse drug events (ADEs) may occur after hospital 
discharge in a variety of settings including PAC.\58\ For older 
patients discharged from the hospital, 80 percent of the medication 
errors occurring during patient handoffs relate to miscommunication 
between providers \59\ and for those transferring to an HHA, medication 
errors typically relate to transmission of inaccurate discharge 
medication lists.\60\ Medication errors and one-fifth of ADEs occur 
during transitions between settings, including admission to or 
discharge from a hospital to home or a PAC setting, or transfer between 
hospitals.61 62
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    \53\ Starmer A.J, Spector N.D., Srivastava R., West, D.C., 
Rosenbluth, G., Allen, A.D., Noble, E.L., & Landrigen, C.P., 
``Changes in medical errors after implementation of a handoff 
program,'' N Engl J Med, 2014, Vol. 37(1), pp. 1803-1812.
    \54\ Kruse, C.S. Marquez, G., Nelson, D., & Polomares, O., ``The 
use of health information exchange to augment patient handoff in 
long-term care: a systematic review,'' Applied Clinical Informatics, 
2018, Vol. 9(4), pp. 752-771.
    \55\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H., 
Thraen, I., Coarr, M.E., & Rupper, R., ``High prevalence of 
medication discrepancies between home health referrals and Centers 
for Medicare and Medicaid Services home health certification and 
plan of care and their potential to affect safety of vulnerable 
elderly adults,'' Journal of the American Geriatrics Society, 2016, 
Vol. 64(11), pp. e166-e170.
    \56\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E., 
Parsons, K., L., & Zuckerman, I.H., ``Medication reconciliation 
during the transition to and from long-term care settings: a 
systematic review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-
75.
    \57\ Levinson, D.R., & General, I., ``Adverse events in skilled 
nursing facilities: national incidence among Medicare 
beneficiaries.'' Washington, DC: U.S. Department of Health and Human 
Services, Office of the Inspector General, February 2014. Available 
at: https://oig.hhs.gov/oei/reports/oei-06-11-00370.pdf.
    \58\ Battles J., Azam I., Grady M., & Reback K., ``Advances in 
patient safety and medical liability,'' AHRQ Publication No. 17-
0017-EF. Rockville, MD: Agency for Healthcare Research and Quality, 
August 2017. Available at: https://www.ahrq.gov/sites/default/files/publications/files/advances-complete_3.pdf.
    \59\ Siefferman, J.W., Lin, E., & Fine, J.S. (2012). Patient 
safety at handoff in rehabilitation medicine. Physical Medicine and 
Rehabilitation Clinics of North America, 23(2), 241-257.
    \60\ Hale, J., Neal, E.B., Myers, A., Wright, K.H.S., Triplett, 
J., Brown, L.B., & Mixon, A.S. (2015). Medication Discrepancies and 
Associated Risk Factors Identified in Home Health patients. Home 
Healthcare Now, 33(9), 493-499. https://doi.org/10.1097/NHH.0000000000000290.
    \61\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer of 
medication information across settings--keeping it free from 
error,'' The American Journal of Nursing, 2005, Vol. 105(3), pp. 31-
36.
    \62\ Gleason, K.M., Groszek, J.M., Sullivan, C., Rooney, D., 
Barnard, C., Noskin, G.A., ``Reconciliation of discrepancies in 
medication histories and admission orders of newly hospitalized 
patients,'' American Journal of Health System Pharmacy, 2004, Vol. 
61(16), pp. 1689-1694.
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    Patients in PAC settings often take multiple medications. 
Consequently, PAC providers regularly are in the position of starting 
complex new medication regimens with little knowledge of the patients 
or their medication history upon admission. Medication discrepancies in 
PAC are common, such as those identified in transition from hospital to 
SNF \63\ and hospital to home.\64\ In one small intervention study, 
approximately 90 percent of the sample of 101 patients experienced at 
least one medication discrepancy in the transition from hospital to 
home care.\65\
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    \63\ Tjia, J., Bonner, A., Briesacher, B.A., McGee, S., Terrill, 
E., Miller, K., ``Medication discrepancies upon hospital to skilled 
nursing facility transitions,'' J Gen Intern Med, 2009, Vol. 24(5), 
pp. 630-635.
    \64\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, I.D., 
``Nurse identified hospital to home medication discrepancies: 
implications for improving transitional care'', Geriatr Nurs, 2011 
Vol. 31(3), pp.188-96.
    \65\ Corbett C.L., Setter S.M., Neumiller J.J., & Wood, I.D., 
``Nurse identified hospital to home medication discrepancies: 
implications for improving transitional care'', Geriatr Nurs, 2011 
Vol. 31(3), pp.188-96.
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    We would define a reconciled medication list as a list of the 
current prescribed and over the counter (OTC) medications, nutritional 
supplements,

[[Page 34647]]

vitamins, and homeopathic and herbal products administered by any route 
to the patient/resident at the time of discharge or transfer. 
Medications may also include but are not limited to total parenteral 
nutrition (TPN) and oxygen. The current medications should include 
those that are: (1) Active, including those that will be discontinued 
after discharge; and (2) those held during the stay and planned to be 
continued/resumed after discharge. If deemed relevant to the patient's/
resident's care by the subsequent provider, medications discontinued 
during the stay may be included.
    A reconciled medication list often includes important information 
about: (1) The patient/resident--including their name, date of birth, 
information, active diagnoses, known medication and other allergies, 
and known drug sensitivities and reactions; and (2) each medication, 
including the name, strength, dose, route of medication administration, 
frequency or timing, purpose/indication, any special instructions (for 
example, crush medications), and, for any held medications, the reason 
for holding the medication and when medication should resume. This 
information can improve medication safety. Additional information may 
be applicable and important to include in the medication list such as 
the patient's/resident's weight and date taken, height and date taken, 
patient's preferred language, patient's ability to self-administer 
medication, when the last dose of the medication was administered by 
the discharging provider, and when the final dose should be 
administered (for example, end of treatment). This is not an exhaustive 
list of the information that could be included in the medication list. 
The suggested elements detailed in the definition above are for 
guidance purposes only and are not a requirement for the types of 
information to be included in a reconciled medication list in order to 
meet the measure criteria.
(b) Stakeholder and TEP Input
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) measure was developed after consideration of feedback 
we received from stakeholders and four TEPs convened by our 
contractors. Further, the proposed measure was developed after 
evaluation of data collected during two pilot tests we conducted in 
accordance with the CMS Measures Management System Blueprint.
    Our measure development contractors convened a TEP, which met on 
September 27, 2016,\66\ January 27, 2017, and August 3, 2017 \67\ to 
provide input on a prior version of this measure. Based on this input, 
we updated the measure concept in late 2017 to include the transfer of 
a specific component of health information--medication information. Our 
measure development contractors reconvened a TEP on April 20, 2018 for 
the purpose of obtaining expert input on the proposed measure, 
including the measure's reliability, components of face validity, and 
the feasibility of implementing the measure across PAC settings. 
Overall, the TEP was supportive of the measure, affirming that the 
measure provides an opportunity to improve the transfer of medication 
information. A summary of the April 20, 2018 TEP proceedings titled 
``Transfer of Health Information TEP Meeting 4-June 2018'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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    \66\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \67\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
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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 proposed measure was tested between June and August 2018 in a 
pilot test that involved 24 PAC facilities/agencies, including five 
IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted 
a total of 801 records. Analysis of agreement between coders within 
each participating facility (266 qualifying pairs) indicated a 93-
percent agreement for this measure. Overall, pilot testing enabled us 
to verify its reliability, components of face validity, and feasibility 
of being implemented across PAC settings. Further, more than half of 
the sites that participated in the pilot test stated during the 
debriefing interviews that the measure could distinguish facilities or 
agencies with higher quality medication information transfer from those 
with lower quality medication information transfer at discharge. The 
pilot test summary report is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(d) Measure Applications Partnership (MAP) Review and Related Measures
    We included the proposed measure on the 2018 Measures Under 
Consideration (MUC) list for HH QRP. The NQF-convened MAP Post-Acute 
Care- Long Term Care (PAC LTC) Workgroup met on December 10, 2018 and 
provided input on this proposed Transfer of Health Information to the 
Provider-Post-Acute Care measure. The MAP conditionally supported this 
measure pending NQF endorsement, noting that the measure can promote 
the transfer of important medication information. The MAP also 
suggested that CMS consider a measure that can be adapted to capture 
bi-directional information exchange and recommended that the medication 
information transferred include important information about supplements 
and opioids. More information about the MAP's recommendations for this 
measure is available at: https://www.qualityforum.org/Projects/i-m/MAP/
PAC-LTC_Workgroup/

[[Page 34648]]

2019_Considerations_for_Implementing_Measures_Draft_Report.aspx.
    As part of the measure development and selection process, we 
identified one NQF-endorsed quality measure related to the proposed 
measure, titled Documentation of Current Medications in the Medical 
Record (NQF #0419e, CMS eCQM ID: CMS68v8). This measure was adopted as 
one of the recommended adult core clinical quality measures for 
eligible professionals for the EHR Incentive Program beginning in 2014, 
and was adopted under the Merit-based Incentive Payment System (MIPS) 
quality performance category beginning in 2017. The measure is 
calculated based on the percentage of visits for patients aged 18 years 
and older for which the eligible professional or eligible clinician 
attests to documenting a list of current medications using all 
resources immediately available on the date of the encounter. The 
proposed Transfer of Health Information to the Provider-Post-Acute Care 
measure addresses the transfer of medication information whereas the 
NQF-endorsed measure #0419e assesses the documentation of medications, 
but not the transfer of such information. Further, the proposed measure 
utilizes standardized patient assessment data elements (SPADEs), which 
is a requirement for measures specified under the Transfer of Health 
Information measure domain under section 1899B(c)(1)(E) of the Act, 
whereas NQF #0419e does not. After review of the NQF-endorsed measure, 
we determined that the proposed Transfer of Health Information to 
Provider-Post-Acute Care measure better addresses the Transfer of 
Health Information measure domain, which requires that at least some of 
the data used to calculate the measure be collected as standardized 
patient assessment data through post-acute care assessment instruments.
    Section 1899B(e)(2)(A) of the Act requires that measures specified 
by the Secretary under section 1899B of the Act be endorsed by the 
consensus-based entity with a contract under section 1890(a) of the 
Act, which is currently the NQF. However, when a feasible and practical 
measure has not been NQF endorsed for a specified area or medical topic 
determined appropriate by the Secretary, section 1899B(e)(2)(B) of the 
Act allows the Secretary to specify a measure that is not NQF endorsed 
as long as due consideration is given to the measures that have been 
endorsed or adopted by the consensus-based entity under a contract with 
the Secretary. For these reasons, we believe that there is currently no 
feasible NQF-endorsed measure that we could adopt under section 
1899B(c)(1)(E) of the Act. However, we note that we intend to submit 
the proposed measure to the NQF for consideration of endorsement when 
feasible.
(e) Quality Measure Calculation
    The proposed Transfer of Health Information to the Provider-Post-
Acute Care (PAC) quality measure is calculated as the proportion of 
quality episodes with a discharge/transfer assessment indicating that a 
current reconciled medication list was provided to the admitting 
provider at the time of discharge/transfer.
    The proposed measure denominator is the total number of quality 
episodes ending in discharge/transfer to an ``admitting provider,'' 
which is defined as: A short-term general hospital, intermediate care, 
home under care of another organized home health service organization 
or a hospice, a hospice in an institutional facility, a SNF, an LTCH, 
an IRF, an inpatient psychiatric facility, or a critical access 
hospital (CAH). These providers were selected for inclusion in the 
denominator because they represent admitting providers captured by the 
current discharge location items on the OASIS. The proposed measure 
numerator is the number of HH quality episodes (Start of Care or 
Resumption of Care OASIS assessment and a Transfer or Discharge OASIS 
Assessment) indicating a current reconciled medication list was 
provided to the admitting provider at the time of discharge/transfer. 
The proposed measure also collects data on how information is exchanged 
in PAC facilities, informing consumers and providers on how information 
was transferred at discharge/transfer. Data pertaining to how 
information is transferred by PAC providers to other providers and/or 
to patients/family/caregivers will provide important information to 
consumers, improving shared-decision making while selecting PAC 
providers. For additional technical information about this proposed 
measure, including information about the measure calculation and the 
standardized items used to calculate this measure, we refer readers to 
the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and Standardized Patient Assessment Data Elements,'' available 
on the website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. The data 
source for the proposed quality measure is the OASIS assessment 
instrument for HH patients.
    For more information about the data submission requirements we are 
proposing for this measure, we refer readers to section V.I.2. of this 
proposed rule.
2. Proposed Transfer of Health Information to the Patient-Post-Acute 
Care (PAC) Measure
    The proposed Transfer of Health Information to the Patient-Post-
Acute Care (PAC) measure is a process-based measure that assesses 
whether or not a current reconciled medication list was provided to the 
patient, family, and/or caregiver when the patient was discharged from 
a PAC setting to a private home/apartment, a board and care home, 
assisted living, a group home or transitional living.
(a) Background
    In 2013, 22.3 percent of all acute hospital discharges were 
discharged to PAC settings, including 11 percent who were discharged to 
home under the care of a home health agency.\68\ The communication of 
health information, such as a reconciled medication list, is critical 
to ensuring safe and effective patient transitions from health care 
settings to home and/or other community settings. Incomplete or missing 
health information, such as medication information, increases the 
likelihood of a risk to patient safety, often life-
threatening.69 70 71 72 73 Individuals who use PAC care 
services are particularly vulnerable to adverse health outcomes due to 
their higher

[[Page 34649]]

likelihood of having multiple comorbid chronic conditions, 
polypharmacy, and complicated transitions between care 
settings.74 75 Upon discharge to home, individuals in PAC 
settings may be faced with numerous medication changes, new medication 
regimes, and follow-up details.76 77 78 The efficient and 
effective communication and coordination of medication information may 
be critical to prevent potentially deadly adverse events. When care 
coordination activities enhance care transitions, these activities can 
reduce duplication of care services and costs of care, resolve 
conflicting care plans, and prevent medical errors.79 80
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    \68\ Tian, W. ``An all-payer view of hospital discharge to 
postacute care,'' May 2016. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb205-Hospital-Discharge-Postacute-Care.jsp.
    \69\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G., 
``Medication reconciliation during transitions of care as a patient 
safety strategy: a systematic review,'' Annals of Internal Medicine, 
2013, Vol. 158(5), pp. 397-403.
    \70\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E., 
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission 
medication reconciliation on adverse drug events from admission 
medication changes,'' Archives of Internal Medicine, 2011, Vol. 
171(9), pp. 860-861.
    \71\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman, 
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital 
admission with unintentional discontinuation of medications for 
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \72\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J., 
``Prescribing errors on admission to hospital and their potential 
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol. 
23(1), pp. 17-25.
    \73\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., & 
Hansen, R.A., ``Medication errors during patient transitions into 
nursing homes: characteristics and association with patient harm,'' 
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6), 
pp. 413-422.
    \74\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H., 
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of 
medication discrepancies between home health referrals and Centers 
for Medicare and Medicaid Services home health certification and 
plan of care and their potential to affect safety of vulnerable 
elderly adults,'' Journal of the American Geriatrics Society, 2016, 
Vol. 64(11), pp. e166-e170.
    \75\ Chhabra, P.T., Rattinger, G.B., Dutcher, S.K., Hare, M.E., 
Parsons, K.L., & Zuckerman, I.H., ``Medication reconciliation during 
the transition to and from long-term care settings: a systematic 
review,'' Res Social Adm Pharm, 2012, Vol. 8(1), pp. 60-75.
    \76\ Brody, A.A., Gibson, B., Tresner-Kirsch, D., Kramer, H., 
Thraen, I., Coarr, M.E., & Rupper, R. ``High prevalence of 
medication discrepancies between home health referrals and Centers 
for Medicare and Medicaid Services home health certification and 
plan of care and their potential to affect safety of vulnerable 
elderly adults,'' Journal of the American Geriatrics Society, 2016, 
Vol. 64(11), pp. e166-e170.
    \77\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman, 
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital 
admission with unintentional discontinuation of medications for 
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
    \78\ Sheehan, O.C., Kharrazi, H., Carl, K.J., Leff, B., Wolff, 
J.L., Roth, D.L., Gabbard, J., & Boyd, C.M., ``Helping older adults 
improve their medication experience (HOME) by addressing medication 
regimen complexity in home healthcare,'' Home Healthcare Now. 2018, 
Vol. 36(1) pp. 10-19.
    \79\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The 
revolving door of rehospitalization from skilled nursing 
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
    \80\ Starmer, A.J., Sectish, T.C., Simon, D.W., Keohane, C., 
McSweeney, M.E., Chung, E.Y., Yoon, C.S., Lipsitz, S.R., Wassner, 
A.J., Harper, M.B., & Landrigan, C.P., ``Rates of medical errors and 
preventable adverse events among hospitalized children following 
implementation of a resident handoff bundle,'' JAMA, 2013, Vol. 
310(21), pp. 2262-2270.
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    Finally, the transfer of a patient's discharge medication 
information to the patient, family, and/or caregiver is a common 
practice and supported by discharge planning requirements for 
participation in Medicare and Medicaid programs.81 82 Most 
PAC EHR systems generate a discharge medication list to promote patient 
participation in medication management, which has been shown to be 
potentially useful for improving patient outcomes and transitional 
care.\83\
---------------------------------------------------------------------------

    \81\ CMS, ``Revision to state operations manual (SOM), Hospital 
Appendix A--Interpretive Guidelines for 42 CFR 482.43, Discharge 
Planning'' May 17, 2013. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-32.pdf.
    \82\ The State Operations Manual Guidance to Surveyors for Long 
Term Care Facilities (Guidance Sec.  483.21(c)(1) Rev. 11-22-17) for 
discharge planning process. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
    \83\ Toles, M., Colon-Emeric, C., Naylor, M.D., Asafu-Adjei, J., 
Hanson, L.C., ``Connect-home: transitional care of skilled nursing 
facility patients and their caregivers,'' Am Geriatr Soc., 2017, 
Vol. 65(10), pp. 2322-2328.
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(b) Stakeholder and TEP Input
    The proposed measure was developed after consideration of feedback 
we received from stakeholders, and four TEPs convened by our 
contractors. Further, the proposed measure was developed after 
evaluation of data collected during two pilot tests, we conducted in 
accordance with the CMS MMS Blueprint.
    Our measure development contractors convened a TEP which met on 
September 27, 2016,\84\ January 27, 2017, and August 3, 2017 \85\ to 
provide input on a prior version of this measure. Based on this input, 
we updated the measure concept in late 2017 to include the transfer of 
a specific component of health information--medication information. Our 
measure development contractors reconvened this TEP on April 20, 2018 
to seek expert input on the measure. Overall, the TEP members supported 
the proposed measure, affirming that the measure provides an 
opportunity to improve the transfer of medication information. Most of 
the TEP members believed that the measure could improve the transfer of 
medication information to patients, families, and caregivers. Several 
TEP members emphasized the importance of transferring information to 
patients and their caregivers in a clear manner using plain language. A 
summary of the April 20, 2018 TEP proceedings titled ``Transfer of 
Health Information TEP Meeting 4--June 2018'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \84\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP_Summary_Report_Final-June-2017.pdf.
    \85\ Technical Expert Panel Summary Report: Development of two 
quality measures to satisfy the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT Act) Domain of Transfer of health 
Information and Care Preferences When an Individual Transitions to 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation 
Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Home Health 
Agencies (HHAs). Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meetings-2-3-Summary-Report_Final_Feb2018.pdf.
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    Our measure development contractors solicited stakeholder feedback 
on the proposed measure by requesting comment on the CMS MMS Blueprint 
website, and accepted comments that were submitted from March 19, 2018 
to May 3, 2018. Several commenters noted the importance of ensuring 
that the instruction provided to patients and caregivers is clear and 
understandable to promote transparent access to medical record 
information and meet the goals of the IMPACT Act. The summary report 
for the March 19 to May 3, 2018 public comment period titled ``IMPACT-- 
Medication Profile Transferred Public Comment Summary Report'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(c) Pilot Testing
    Between June and August 2018, we held a pilot test involving 24 PAC 
facilities/agencies, including five IRFs, six SNFs, six LTCHs, and 
seven HHAs. The 24 pilot sites submitted a total of 801 assessments. 
Analysis of agreement between coders within each participating facility 
(241 qualifying pairs) indicated 87 percent agreement for this measure. 
Overall, pilot testing enabled us to verify its reliability, components 
of face validity, and feasibility of being implemented the proposed 
measure across PAC settings. Further, more than half of the sites that 
participated in the pilot test stated, during debriefing interviews, 
that the measure could distinguish facilities or agencies with higher 
quality medication information transfer from those with lower quality 
medication information transfer at discharge. The pilot test summary 
report is available at: https://www.cms.gov/Medicare/Quality-
Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-

[[Page 34650]]

Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. 
The summary report for pilot testing conducted in 2017 of a previous 
version of the data element, at that time intended for benchmarking 
purposes only, is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(d) Measure Applications Partnership (MAP) Review and Related Measures
    This measure was submitted to the 2018 MUC list for HH QRP. The 
NQF-convened MAP PAC-LTC Workgroup met on December 10, 2018 and 
provided input on the use of the proposed Transfer of Health 
Information to the Patient-Post Acute-Care measure. The MAP 
conditionally supported this measure pending NQF endorsement, noting 
that the measure can promote the transfer of important medication 
information to the patient. The MAP recommended that providers transmit 
medication information to patients that is easy to understand because 
health literacy can impact a person's ability to take medication as 
directed. More information about the MAP's recommendations for this 
measure is available at: 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 
proposed Transfer of Health Information to the Patient-Post-Acute Care 
(PAC), which requires that at least some of the data used to calculate 
the measure be collected as standardized patient assessment data 
through the post-acute care assessment instruments, we believe that 
there is currently no feasible NQF-endorsed measure that we could adopt 
under section 1899B(c)(1)(E) of the Act. However, we note that we 
intend to submit the proposed measure to the NQF for consideration of 
endorsement when feasible.
(e) Quality Measure Calculation
    The calculation of the proposed Transfer of Health Information to 
Patient-Post-Acute Care measure would be based on the proportion of 
quality episodes with a discharge assessment indicating that a current 
reconciled medication list was provided to the patient, family, and/or 
caregiver at the time of discharge.
    The proposed measure denominator is the total number of HH quality 
episodes ending in discharge to a private home/apartment without any 
further services, a board and care home, assisted living, a group home 
or transitional living. These health care providers and settings were 
selected for inclusion in the denominator because they represent 
discharge locations captured by items on the OASIS. The proposed 
measure numerator is the number of HH quality episodes with an OASIS 
discharge assessment indicating a current reconciled medication list 
was provided to the patient, family, and/or caregiver at the time of 
discharge. We believe that data pertaining to how information is 
transferred by PAC providers to other providers and/or to patients/
family/caregivers will provide important information to consumers, 
improving shared-decision making while selecting PAC providers. For 
technical information about this proposed measure including information 
about the measure calculation, we refer readers to the document titled 
``Proposed Specifications for HH QRP Quality Measures and Standardized 
Patient Assessment Data Elements,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html
    For more information about the data submission requirements we are 
proposing for this measure, we refer readers to section V.I.2. of this 
proposed rule.
3. Proposed Update to the Discharge to Community (DTC)--Post Acute Care 
(PAC) Home Health (HH) Quality Reporting Program (QRP) Measure
    We are proposing to update the specifications for the DTC--PAC HH 
QRP measure to exclude baseline nursing facility (NF) residents from 
the measure. This proposed measure exclusion aligns with the proposed 
updates to measure exclusions for the DTC-PAC measures utilized in 
quality reporting programs for other PAC providers, as outlined in the 
FY2020 PPS proposed rules for IRFs and SNFs as well as for LTCHs in the 
FY2020 IPPS/LTCH PPS proposed rule. This measure assesses successful 
discharge to the community from an HHA, with successful discharge to 
the community including no unplanned re-hospitalizations and no death 
in the 31 days following discharge. We adopted this measure in the CY 
2017 HH PPS final rule (81 FR 76765 through 76770).
    The DTC-PAC HH QRP measure does not currently exclude baseline NF 
residents. We have now developed a methodology to identify and exclude 
baseline NF residents using the Minimum Data Set (MDS) and have 
conducted additional measure testing work. To identify baseline NF 
residents, we examine any historical MDS data in the 180 days preceding 
the qualifying prior acute care admission and index HH episode of care 
start date. Presence of an OBRA (Omnibus Budget Reconciliation Act)-
only assessment (not a SNF PPS assessment) with no intervening 
community discharge between the OBRA assessment and acute care 
admission date flags the index HH episode of care as baseline NF 
resident. We assessed the impact of the baseline NF resident exclusion 
on HH patient- and agency-level discharge to community rates using CY 
2016 and CY 2017 Medicare FFS claims data. Baseline NF residents 
represented 0.13 percent of the measure population after all measure 
exclusions were applied. The national observed patient-level discharge 
to community rate was 78.05 percent when baseline NF residents were 
included in the measure, increasing to 78.08 percent when they were 
excluded from the measure. After excluding baseline NF residents to 
align with current or proposed exclusions in other PAC settings, the 
agency-level risk-standardized discharge to community rate ranged from 
3.21 percent to 100 percent, with a mean of 77.39 percent and standard 
deviation of 17.27 percentage points, demonstrating a performance gap 
in this domain. That is, the results show that there is a wide range in 
measure results, emphasizing the opportunity for providers to improve 
their measure performance.
    Accordingly, we are proposing to exclude baseline NF residents from 
the DTC-PAC HH QRP measure beginning with the CY 2021 HH QRP. We are 
proposing to define ``baseline NF residents'' for purposes of this 
measure as HH patients who had a long-term NF stay in the 180 days 
preceding their hospitalization and HH episode, with no

[[Page 34651]]

intervening community discharge between the NF stay and qualifying 
hospitalization. We are currently using MDS assessments, which are 
required quarterly for NF residents, to identify baseline NF residents. 
A 180-day lookback period ensures that we will capture both quarterly 
OBRA assessments identifying NF residency and any discharge assessments 
to determine if there was a discharge to community from NF.
    For additional technical information regarding the DTC-PAC HH QRP 
measure, including technical information about the proposed exclusion, 
we refer readers to the document titled ``Proposed Specifications for 
HH QRP Quality Measures and Standardized Patient Assessment Data 
Elements,'' available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.

F. HH QRP Quality Measures, Measure Concepts, and Standardized Patient 
Assessment Data Elements Under Consideration for Future Years: Request 
for Information

    We are seeking input on the importance, relevance, appropriateness, 
and applicability of each of the measures, standardized patient 
assessment data elements (SPADEs), and measure concepts under 
consideration listed in the Table 27 for future years in the HH QRP.
[GRAPHIC] [TIFF OMITTED] TP18JY19.070

    While we will not be responding to comment submissions in response 
to this Request for Information in the CY 2020 HH PPS final rule, nor 
will we be finalizing any of these measures, measure concepts, and 
SPADEs under consideration for the HH QRP in this CY 2020 HH PPS final 
rule, we intend to use this input to inform our future measure and 
SPADE development efforts.

G. Proposed Standardized Patient Assessment Data Reporting Beginning 
With the CY 2022 HH QRP

    Section 1895(b)(3)(B)(v)(IV)(bb) of the Act requires that, for CY 
2019 (beginning January 1, 2019) and each subsequent year, HHAs report 
standardized patient assessment data required under section 1899B(b)(1) 
of the Act. Section 1899B(a)(1)(C) of the Act requires, in part, the 
Secretary to modify the PAC assessment instruments in order for PAC 
providers, including HHAs, to submit SPADEs under the Medicare program. 
Section 1899B(b)(1)(A) of the Act requires that PAC providers must 
submit SPADEs under applicable reporting provisions, (which for HHAs is 
the HH QRP) with respect to the admissions and discharges of an 
individual (and more frequently as the Secretary deems appropriate), 
and section 1899B(b)(1)(B) defines standardized patient assessment data 
as data required for at least the quality measures described in section 
1899B(c)(1) of the Act and that is with respect to the following 
categories: (1) Functional status, such as mobility and self-care at 
admission to a PAC provider and before discharge from a PAC provider; 
(2) cognitive function, such as ability to express ideas and to 
understand, and mental status, such as depression and dementia; (3) 
special services, treatments, and interventions, such as need for 
ventilator use, dialysis, chemotherapy, central line placement, and 
total parenteral nutrition; (4) medical conditions and comorbidities, 
such as diabetes, congestive heart failure, and pressure ulcers; (5) 
impairments, such as incontinence and an impaired ability to hear, see, 
or swallow; and (6) other categories deemed necessary and appropriate 
by the Secretary.
    In the CY 2018 HH PPS proposed rule (82 FR 35355 through 35371), we 
proposed to adopt SPADEs that would satisfy the first five categories. 
While many commenters expressed support for our adoption of SPADEs, 
including support for our broader standardization goal and support for 
the clinical usefulness of specific proposed SPADEs in general, we did 
not finalize the majority of our SPADE proposals in recognition of the 
concern raised by many commenters that we were moving too fast to adopt 
the SPADEs and modify our assessment instruments in light of all of the 
other requirements we were also adopting under the IMPACT Act at that 
time (82 FR 51737 through 51740). In addition, we noted our intention 
to conduct extensive testing to ensure that the standardized patient 
assessment data elements we select are reliable, valid, and appropriate 
for their intended use (82 FR 51732 through 51733).
    However, we did, finalize the adoption of SPADEs for two of the 
categories described in section 1899B(b)(1)(B) of the Act: (1) 
Functional status: Data elements currently reported

[[Page 34652]]

by HHAs to calculate the measure Application of Percent of Long-Term 
Care Hospital Patients with an Admission and Discharge Functional 
Assessment and a Care Plan That Addresses Function (NQF #2631) along 
with the additional data elements in Section GG: Functional Abilities 
and Goals; and (2) Medical conditions and comorbidities: The data 
elements used to calculate the pressure ulcer measures, Percent of 
Residents or Patients with Pressure Ulcers That Are New or Worsened 
(Short Stay) (NQF #0678) and the replacement measure, Changes in Skin 
Integrity Post-Acute Care: Pressure Ulcer/Injury. We stated that these 
data elements were important for care planning, known to be valid and 
reliable, and already being reported by HHAs for the calculation of 
quality measures (82 FR 51733 through 51735).
    Since we issued the CY 2018 HH PPS final rule, HHAs have had an 
opportunity to familiarize themselves with other new reporting 
requirements that we have adopted under the IMPACT Act. We have also 
conducted further testing of the proposed SPADEs, as described more 
fully elsewhere in this proposed rule, and believe that this testing 
supports their use in our PAC assessment instruments. Therefore, we are 
now proposing to adopt many of the same SPADEs that we previously 
proposed to adopt, along with other SPADEs.
    We are proposing that HHAs would be required to report these SPADEs 
beginning with the CY 2022 HH QRP. If finalized as proposed, HHAs would 
be required to report this data with respect to admissions and 
discharges that occur between January 1, 2021 and June 30, 2021 for the 
CY 2022 HH QRP. Beginning with the CY 2023 HH QRP, we propose that HHAs 
must report data with respect to admissions and discharges that occur 
the successive calendar year (for example, data from FY 2021 for the CY 
2023 HH QRP and data from FY 2022 for the CY 2024 HH QRP). For the 
purposes of the HH QRP, we are proposing that HHAs must submit SPADEs 
with respect to start of care (SOC), resumption of care (ROC), and 
discharge with the exception of Hearing, Vision, Race, and Ethnicity 
SPADEs, which will only be collected with respect to SOC. We are 
proposing to use SOC for purposes of admissions because, in the HH 
setting, the start of care is functionally the same as an admission.
    We are proposing that HHAs that submit the Hearing, Vision, Race, 
and Ethnicity SPADEs with respect to SOC only will be deemed to have 
submitted those SPADEs with respect to both admission and discharge, 
because it is unlikely that the assessment of those SPADEs at admission 
will differ from the assessment of the same SPADEs at discharge.
    We considered the burden of assessment-based data collection and 
aimed to minimize additional burden by evaluating whether any data that 
is currently collected through one or more PAC assessment instruments 
could be collected as SPADE. In selecting the proposed SPADEs in this 
proposed rule, we also took into consideration the following factors 
with respect to each data element:
     Overall clinical relevance;
     Interoperable exchange to facilitate care coordination 
during transitions in care;
     Ability to capture medical complexity and risk factors 
that can inform both payment and quality;
     Scientific reliability and validity, general consensus 
agreement for its usability.
    In identifying the SPADEs proposed, we additionally drew on input 
from several sources, including TEPs, public input, and the results of 
a recent National Beta Test of candidate data elements conducted by our 
data element (hereafter ``National Beta Test''), contractor.
    The National Beta Test collected data from 3,121 patients and 
residents across 143 LTCHs, SNFs, IRFs, and HHAs from November 2017 to 
August 2018 to evaluate the feasibility, reliability, and validity of 
candidate data elements across PAC settings. The National Beta Test 
also gathered feedback on the candidate data elements from staff who 
administered the test protocol in order to understand usability and 
workflow of the candidate data elements. More information on the 
methods, analysis plan, and results for the National Beta Test can be 
found in the document titled, ``Development and Evaluation of Candidate 
Standardized Patient Assessment Data Elements: Findings from the 
National Beta Test (Volume 2),'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Further, to inform the proposed SPADEs, we took into account 
feedback from stakeholders, as well as from technical and clinical 
experts, including feedback on whether the candidate data elements 
would support the factors described previously. Where relevant, we also 
took into account the results of the Post-Acute Care Payment Reform 
Demonstration (PAC PRD) that took place from 2006 to 2012.

H. Proposed Standardized Patient Assessment Data by Category

1. Cognitive Function and Mental Status Data
    A number of underlying conditions, including dementia, stroke, 
traumatic brain injury, side effects of medication, metabolic and/or 
endocrine imbalances, delirium, and depression, can affect cognitive 
function and mental status in PAC patient and resident populations.\86\ 
The assessment of cognitive function and mental status by PAC providers 
is important because of the high percentage of patients and residents 
with these conditions,\87\ and because these assessments provide 
opportunity for improving quality of care.
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    \86\ National Institute on Aging. (2014). Assessing Cognitive 
Impairment in Older Patients. A Quick Guide for Primary Care 
Physicians. Retrieved from: https://www.nia.nih.gov/alzheimers/publication/assessing-cognitive-impairment-older-patients.
    \87\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute 
Care Payment Reform Demonstration (Final report, Volume 4 of 4). 
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    Symptoms of dementia may improve with pharmacotherapy, occupational 
therapy, or physical activity,88 89 90 and promising 
treatments for severe traumatic brain injury are currently being 
tested.\91\ For older patients and residents diagnosed with depression, 
treatment options to reduce symptoms and improve quality of life 
include antidepressant medication and 
psychotherapy,92 93 94 95 and targeted

[[Page 34653]]

services, such as therapeutic recreation, exercise, and restorative 
nursing, to increase opportunities for psychosocial interaction.\96\
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    \88\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for 
Alzheimer's Disease: Are They Effective? Pharmacology & 
Therapeutics, 35, 208-11.
    \89\ Graff M.J., Vernooij-Dassen M.J., Thijssen M., Dekker J., 
Hoefnagels W.H., Rikkert M.G.O. (2006). Community Based Occupational 
Therapy for Patients with Dementia and their Care Givers: Randomised 
Controlled Trial. BMJ, 333(7580): 1196.
    \90\ Bherer L., Erickson K.I., Liu-Ambrose T. (2013). A Review 
of the Effects of Physical Activity and Exercise on Cognitive and 
Brain Functions in Older Adults. Journal of Aging Research, 657508.
    \91\ Giacino J.T., Whyte J., Bagiella E., et al. (2012). 
Placebo-controlled trial of amantadine for severe traumatic brain 
injury. New England Journal of Medicine, 366(9), 819-826.
    \92\ Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd, Carpenter 
D., Docherty J.P., Ross R.W. (2001). Pharmacotherapy of depression 
in older patients: A summary of the expert consensus guidelines. 
Journal of Psychiatric Practice, 7(6), 361-376.
    \93\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined 
psychotherapy/pharmacotherapy for late life depression. Biological 
Psychiatry, 52(3), 293-303.
    \94\ Hollon S.D., Jarrett R.B., Nierenberg A.A., Thase M.E., 
Trivedi M., Rush A.J. (2005). Psychotherapy and medication in the 
treatment of adult and geriatric depression: Which monotherapy or 
combined treatment? Journal of Clinical Psychiatry, 66(4), 455-468.
    \95\ Wagenaar D, Colenda CC, Kreft M, Sawade J, Gardiner J, 
Poverejan E. (2003). Treating depression in nursing homes: Practice 
guidelines in the real world. J Am Osteopath Assoc. 103(10), 465-
469.
    \96\ Crespy SD, Van Haitsma K, Kleban M, Hann CJ. Reducing 
Depressive Symptoms in Nursing Home Residents: Evaluation of the 
Pennsylvania Depression Collaborative Quality Improvement Program. J 
Healthc Qual. 2016. Vol. 38, No. 6, pp. e76-e88.
---------------------------------------------------------------------------

    In alignment with our Meaningful Measures Initiative, accurate 
assessment of cognitive function and mental status of patients and 
residents in PAC is expected to make care safer by reducing harm caused 
in the delivery of care; promoting effective prevention and treatment 
of chronic disease; strengthening person and family engagement as 
partners in their care; and promoting effective communication and 
coordination of care. For example, standardized assessment of cognitive 
function and mental status of patients and residents in PAC will 
support establishing a baseline for identifying changes in cognitive 
function and mental status (for example, delirium), anticipating the 
patient's or resident's ability to understand and participate in 
treatments during a PAC stay, ensuring patient and resident safety (for 
example, risk of falls), and identifying appropriate support needs at 
the time of discharge or transfer. SPADEs will enable or support 
clinical decision-making and early clinical intervention; person-
centered, high quality care through facilitating better care continuity 
and coordination; better data exchange and interoperability between 
settings; and longitudinal outcome analysis. Therefore, reliable SPADEs 
assessing cognitive function and mental status are needed in order to 
initiate a management program that can optimize a patient's or 
resident's prognosis and reduce the possibility of adverse events. We 
describe each of the proposed cognitive function and mental status data 
SPADEs elsewhere in the proposed rule.
    We are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to cognitive 
function and mental status.
a. Brief Interview for Mental Status (BIMS)
    We are proposing that the data elements that comprise the BIMS meet 
the definition of standardized patient assessment data with respect to 
cognitive function and mental status under section 1899B(b)(1)(B)(ii) 
of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35356 
through 35357), dementia and cognitive impairment are associated with 
long-term functional dependence and, consequently, poor quality of life 
and increased health care costs and mortality.\97\ This makes 
assessment of mental status and early detection of cognitive decline or 
impairment critical in the PAC setting. The intensity of routine 
nursing care is higher for patients and residents with cognitive 
impairment than those without, and dementia is a significant variable 
in predicting readmission after discharge to the community from PAC 
providers.\98\
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    \97\ Ag[uuml]ero-Torres, H., Fratiglioni, L., Guo, Z., Viitanen, 
M., von Strauss, E., & Winblad, B. (1998). ``Dementia is the major 
cause of functional dependence in the elderly: 3-year follow-up data 
from a population-based study.'' Am J of Public Health 88(10): 1452-
1456.
    \98\ RTI International. Proposed Measure Specifications for 
Measures Proposed in the FY 2017 IRF QRP NPRM. Research Triangle 
Park, NC. 2016.
---------------------------------------------------------------------------

    The BIMS is a performance-based cognitive assessment screening tool 
that assesses repetition, recall with and without prompting, and 
temporal orientation. The data elements that make up the BIMS are seven 
questions on the repetition of three words, temporal orientation, and 
recall that result in a cognitive function score. The BIMS was 
developed to be a brief objective screening tool with a focus on 
learning and memory. As a brief screener, the BIMS was not designed to 
diagnose dementia or cognitive impairment, but rather to be a 
relatively quick and easy to score assessment that could identify 
cognitively impaired patients as well as those who may be at risk for 
cognitive decline and require further assessment. It is currently in 
use in two of the PAC assessments: The MDS in SNFs and the IRF-PAI used 
by IRFs. For more information on the BIMS, we refer readers to the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The data elements that comprise the BIMS were first proposed as 
SPADEs in the CY 2018 HH PPS proposed rule (82 FR 35356 through 35357). 
In that proposed rule, we stated that the proposal was informed by 
input we received through a call for input published on the CMS 
Measures Management System Blueprint website. Input submitted from 
August 12 to September 12, 2016 expressed support for use of the BIMS, 
noting that it is reliable, feasible to use across settings, and will 
provide useful information about patients and residents. We also stated 
that those commenters had noted that the data collected through the 
BIMS will provide a clearer picture of patient or resident complexity, 
help with the care planning process, and be useful during care 
transitions and when coordinating across providers. A summary report 
for the August 12 to September 12, 2016 public comment period titled 
``SPADE August 2016 Public Comment Summary Report'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, we 
received public comments in support of the use of the BIMS in the HH 
setting. However, a commenter suggested the BIMS should be administered 
with respect to both admission and discharge, and another commenter 
encouraged its use at follow-up assessments. Another commenter 
expressed support for the BIMS to assess significant cognitive 
impairment, but a few commenters suggested alternative cognitive 
assessments as more appropriate for the HH settings, such as 
assessments that would capture mild cognitive impairment and 
``functional cognition.''
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the BIMS was included in the National Beta Test of candidate data 
elements conducted by our data element contractor from November 2017 to 
August 2018. Results of this test found the BIMS to be feasible and 
reliable for use with PAC patients and residents. More information 
about the performance of the BIMS in the National Beta Test can be 
found in the document titled, ``Proposed Specifications for HH QRP 
Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the BIMS, and 
the TEP supported the assessment of patient or resident cognitive 
status with respect to both admission and discharge. A summary of the 
September 17, 2018 TEP

[[Page 34654]]

meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Some commenters expressed concern that the BIMS, if used alone, 
may not be sensitive enough to capture the range of cognitive 
impairments, including mild cognitive impairment (MCI). A summary of 
the public input received from the November 27, 2018 stakeholder 
meeting titled ``Input on SPADEs Received After November 27, 2018 
Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We understand the concerns raised by stakeholders that BIMS, if 
used alone, may not be sensitive enough to capture the range of 
cognitive impairments, including functional cognition and MCI, but note 
that the purpose of the BIMS data elements as SPADEs is to screen for 
cognitive impairment in a broad population. We also acknowledge that 
further cognitive tests may be required based on a patient's condition 
and will take this feedback into consideration in the development of 
future standardized assessment data elements. However, taking together 
the importance of assessing cognitive status, stakeholder input, and 
strong test results, we are proposing that the BIMS data elements meet 
the definition of standardized patient assessment data with respect to 
cognitive function and mental status under section 1899B(b)(1)(B)(ii) 
of the Act and to adopt the BIMS as standardized patient assessment 
data for use in the HH QRP.
b. Confusion Assessment Method (CAM)
    In this proposed rule, we are proposing that the data elements that 
comprise the Confusion Assessment Method (CAM) meet the definition of 
standardized patient assessment data with respect to cognitive function 
and mental status under section 1899B(b)(1)(B)(ii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35357), the 
CAM was developed to identify the signs and symptoms of delirium. It 
results in a score that suggests whether a patient or resident should 
be assigned a diagnosis of delirium. Because patients and residents 
with multiple comorbidities receive services from PAC providers, it is 
important to assess delirium, which is associated with a high mortality 
rate and prolonged duration of stay in hospitalized older adults.\99\ 
Assessing these signs and symptoms of delirium is clinically relevant 
for care planning by PAC providers.
---------------------------------------------------------------------------

    \99\ Fick, D.M., Steis, M.R., Waller, J.L., & Inouye, S.K. 
(2013). ``Delirium superimposed on dementia is associated with 
prolonged length of stay and poor outcomes in hospitalized older 
adults.'' J of Hospital Med 8(9): 500-505.
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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 are proposing the 
four-item version of the CAM that assesses acute change in mental 
status, inattention, disorganized thinking, and altered level of 
consciousness. For more information on the CAM, we refer readers to the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The data elements that comprise the CAM were first proposed as 
SPADEs in the CY 2018 HH PPS proposed rule (82 FR 35357). In that 
proposed rule, we stated that the proposal was informed by input we 
received through a call for input published on the CMS Measures 
Management System Blueprint website. Input submitted on the CAM from 
August 12 to September 12, 2016 expressed support for use of the CAM, 
noting that it would provide important information for care planning 
and care coordination and, therefore, contribute to quality 
improvement. We also stated that those commenters had noted the CAM is 
particularly helpful in distinguishing delirium and reversible 
confusion from other types of cognitive impairment. A summary report 
for the August 12 to September 12, 2016 public comment period titled 
``SPADE August 2016 Public Comment Summary Report'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the CAM to assess significant 
cognitive impairment but noted that functional cognition should also be 
assessed. Another commenter suggested the CAM was not suitable for the 
HH setting and noted that the additional cognition items would be 
redundant with existing assessment items in the OASIS data set.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the CAM was included in the National Beta Test of candidate data 
elements conducted by our data element contractor from November 2017 to 
August 2018. Results of this test found the CAM to be feasible and 
reliable for use with PAC patients and residents. More information 
about the performance of the CAM in the National Beta Test can be found 
in the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, although they did not specifically discuss the CAM 
data elements, the TEP supported the assessment of patient or resident 
cognitive status with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of

[[Page 34655]]

stakeholders to present the results of the National Beta Test and 
solicit additional comments. General input on the testing and item 
development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing delirium, stakeholder 
input, and strong test results, we are proposing that the CAM data 
elements meet the definition of standardized patient assessment data 
with respect to cognitive function and mental status under section 
1899B(b)(1)(B)(ii) of the Act and to adopt CAM as standardized patient 
assessment data for use in the HH QRP.
c. Patient Health Questionnaire-2 to 9 (PHQ-2 to 9)
    We are proposing that the Patient Health Questionnaire-2 to 9 (PHQ-
2 to 9) data elements meet the definition of standardized patient 
assessment data with respect to cognitive function and mental status 
under section 1899B(b)(1)(B)(ii) of the Act. The proposed data elements 
are based on the PHQ-2 mood interview, which focuses on only the two 
cardinal symptoms of depression, and the longer PHQ-9 mood interview, 
which assesses presence and frequency of nine signs and symptoms of 
depression. The name of the data element, the PHQ-2 to 9, refers to an 
embedded skip pattern that transitions patients with a threshold level 
of symptoms in the PHQ-2 to the longer assessment of the PHQ-9. The 
skip pattern is described elsewhere in this proposed rule.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35358 
through 35359), depression is a common and under-recognized mental 
health condition. Assessments of depression help PAC providers better 
understand the needs of their patients and residents by: Prompting 
further evaluation after establishing a diagnosis of depression; 
elucidating the patient's or resident's ability to participate in 
therapies for conditions other than depression during their stay; and 
identifying appropriate ongoing treatment and support needs at the time 
of discharge.
    The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The 
PHQ-2 consists of questions about only the first two symptoms addressed 
in the PHQ-9: Depressed mood and anhedonia (inability to feel 
pleasure), which are the cardinal symptoms of depression. The PHQ-2 has 
performed well as both a screening tool for identifying depression, to 
assess depression severity, and to monitor patient mood over 
time.100 101 If a patient demonstrates signs of depressed 
mood and anhedonia under the PHQ-2, then the patient is administered 
the lengthier PHQ-9. This skip pattern (also referred to as a gateway) 
is designed to reduce the length of the interview assessment for 
patients who fail to report the cardinal symptoms of depression. The 
design of the PHQ-2 to 9 reduces the burden that would be associated 
with the full PHQ-9, while ensuring that patients with indications of 
depressive symptoms based on the PHQ-2 receive the longer assessment.
---------------------------------------------------------------------------

    \100\ Li, C., Friedman, B., Conwell, Y., & Fiscella, K. (2007). 
``Validity of the Patient Health Questionnaire 2 (PHQ-2) in 
identifying major depression in older people.'' J of the A 
Geriatrics Society, 55(4): 596-602.
    \101\ L[ouml]we, B., Kroenke, K., & Gr[auml]fe, K. (2005). 
``Detecting and monitoring depression with a two-item questionnaire 
(PHQ-2).'' J of Psychosomatic Research, 58(2): 163-171.
---------------------------------------------------------------------------

    Components of the proposed data elements are currently used in the 
OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We are proposing 
to add the additional data elements of the PHQ-9 to the OASIS to 
replace M1730, Depression Screening. We are proposing to alter the 
administration instructions for the existing and new data elements to 
adopt the PHQ-2 to 9 gateway logic, meaning that administration of the 
full PHQ-9 is contingent on patient responses to questions about the 
cardinal symptoms of depression. For more information on the PHQ-2 to 
9, we refer readers to the document titled, ``Proposed Specifications 
for HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The PHQ-2 data elements were first proposed as SPADEs in the CY 
2018 HH proposed rule (82 FR 35358 through 35359). In that proposed 
rule, we stated that the proposal was informed by input we received 
from the TEP convened by our data element contractor on April 6 and 7, 
2016. The TEP members particularly noted that the brevity of the PHQ-2 
made it feasible to administer with low burden for both assessors and 
PAC patients or residents. A summary of the April 6 and 7, 2016 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (First 
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    That rule proposal was also informed by public input that we 
received through a call for input published on the CMS Measures 
Management System Blueprint website. Input was submitted from August 12 
to September 12, 2016 on three versions of the PHQ depression screener: 
The PHQ-2; the PHQ-9; and the PHQ-2 to 9 with the skip pattern design. 
Many commenters were supportive of the standardized assessment of mood 
in PAC settings, given the role that depression plays in well-being. 
Several commenters expressed support for an approach that would use 
PHQ-2 as a gateway to the longer PHQ-9 while still potentially reducing 
burden on most patients and residents, as well as test administrators, 
and ensuring the administration of the PHQ-9, which exhibits higher 
specificity,\102\ for patients and residents who showed signs and 
symptoms of depression on the PHQ-2. A summary report for to the 
September 12, 2016 public comment period titled ``SPADE August 2016 
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \102\ Arroll B, Goodyear-Smith F, Crengle S. Gunn J. Kerse N. 
Fishman T. et al. Validation of PHQ-2 and PHQ-9 to screen for major 
depression in the primary care population. Annals of family 
medicine. 2010; 8(4):348-53. doi: 10.1370/afm.1139 pmid:20644190; 
PubMed Central PMCID: PMC2906530.
---------------------------------------------------------------------------

    In response to our proposal in the CY 2018 HH PPS proposed rule, we 
received public comments in support of the PHQ-2, with a few commenters 
noting the limitation that the PHQ-2 is not appropriate for patients 
who are physically or cognitively impaired.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the PHQ-2 to 9 data elements were included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the PHQ-2 to 9 to be feasible and reliable for use with PAC 
patients and residents. More

[[Page 34656]]

information about the performance of the PHQ-2 to 9 in the National 
Beta Test can be found in the document titled, ``Proposed 
Specifications for CY 2020 HH QRP Quality Measures and Standardized 
Patient Assessment Data Elements,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, for the purpose of soliciting input on the PHQ-2 to 
9. The TEP was supportive of the PHQ-2 to 9 data element set as a 
screener for signs and symptoms of depression. The TEP's discussion 
noted that symptoms evaluated by the full PHQ-9 (for example, 
concentration, sleep, appetite) had relevance to care planning and the 
overall well-being of the patient or resident, but that the gateway 
approach of the PHQ-2 to 9 would be appropriate as a depression 
screening assessment, as it depends on the well-validated PHQ-2 and 
focuses on the cardinal symptoms of depression. A summary of the 
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel 
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing depression, stakeholder 
input, and strong test results, we are proposing that the PHQ-2 to 9 
data elements meet the definition of standardized patient assessment 
data with respect to cognitive function and mental status under section 
1899B(b)(1)(B)(ii) of the Act and to adopt the PHQ-2 to 9 data elements 
as standardized patient assessment data for use in the HH QRP.
2. Special Services, Treatments, and Interventions Data
    Special services, treatments, and interventions performed in PAC 
can have a major effect on an individual's health status, self-image, 
and quality of life. The assessment of these special services, 
treatments, and interventions in PAC is important to ensure the 
continuing appropriateness of care for the patients and residents 
receiving them, and to support care transitions from one PAC provider 
to another, an acute care hospital, or discharge. In alignment with our 
Meaningful Measures Initiative, accurate assessment of special 
services, treatments, and interventions of patients and residents 
served by PAC providers is expected to make care safer by reducing harm 
caused in the delivery of care; promoting effective prevention and 
treatment of chronic disease; strengthening person and family 
engagement as partners in their care; and promoting effective 
communication and coordination of care.
    For example, standardized assessment of special services, 
treatments, and interventions used in PAC can promote patient and 
resident safety through appropriate care planning (for example, 
mitigating risks such as infection or pulmonary embolism associated 
with central intravenous access), and identifying life-sustaining 
treatments that must be continued, such as mechanical ventilation, 
dialysis, suctioning, and chemotherapy, at the time of discharge or 
transfer. Standardized assessment of these data elements will enable or 
support: Clinical decision-making and early clinical intervention; 
person-centered, high quality care through, for example, facilitating 
better care continuity and coordination; better data exchange and 
interoperability between settings; and longitudinal outcome analysis. 
Therefore, reliable data elements assessing special services, 
treatments, and interventions are needed to initiate a management 
program that can optimize a patient's or resident's prognosis and 
reduce the possibility of adverse events. We provide rationale and 
further support for each of the proposed data elements and in the 
document titled, ``Proposed Specifications for CY 2020 HH QRP Quality 
Measures and Standardized Patient Assessment Data Elements,'' available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by our data element contractor provided input on the 
data elements for special services, treatments, and interventions. In a 
meeting held on January 5 and 6, 2017, the TEP found that these data 
elements are appropriate for standardization because they would provide 
useful clinical information to inform care planning and care 
coordination. The TEP affirmed that assessment of these services and 
interventions is standard clinical practice, and that the collection of 
these data by means of a list and checkbox format would conform to 
common workflow for PAC providers. A summary of the January 5 and 6, 
2017 TEP meeting titled ``SPADE Technical Expert Panel Summary (Second 
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Comments on the category of special services, treatments, and 
interventions were also submitted by stakeholders during the CY 2018 HH 
PPS proposed rule (82 FR 35359 through 35369) public comment period. A 
few commenters expressed support for the special services, treatments, 
and interventions data elements but requested that a vendor be 
contracted to support OASIS questions and answers. A commenter noted 
that many of these data elements were redundant with current assessment 
items and encouraged CMS to eliminate the redundancy by removing items 
similar to the proposed data elements. Another commenter noted that 
collecting these data elements on patients that come to the HH setting 
from non-affiliated entities can be challenging. The Medicare Payment 
Advisory Commission supported the addition of data elements related to 
specific services, treatments, and interventions, but cautioned that 
such data elements, when used for risk adjustment, may be susceptible 
to inappropriate manipulation by providers and expressed that CMS may 
want to consider requiring a physician signature to attest that the 
reported service was reasonable and necessary. CMS is not proposing to 
require a physician signature because the existing Conditions of 
Participation for HHAs

[[Page 34657]]

already require accurate reporting of patient assessment data, and a 
physician signature would be redundant. We reported this comment in 
order to accurately represent the public comments received on these 
proposals in the CY 2017 HH PPS proposed rule.
    We are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to special 
services, treatments, and interventions.
a. Cancer Treatment: Chemotherapy (IV, Oral, Other)
    We are proposing that the Chemotherapy (IV, Oral, Other) data 
element meets the definition of standardized patient assessment data 
with respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35359 
through 35360), chemotherapy is a type of cancer treatment that uses 
drugs to destroy cancer cells. It is sometimes used when a patient has 
a malignancy (cancer), which is a serious, often life-threatening or 
life-limiting condition. Both intravenous (IV) and oral chemotherapy 
have serious side effects, including nausea/vomiting, extreme fatigue, 
risk of infection due to a suppressed immune system, anemia, and an 
increased risk of bleeding due to low platelet counts. Oral 
chemotherapy can be as potent as chemotherapy given by IV but can be 
significantly more convenient and less resource-intensive to 
administer. Because of the toxicity of these agents, special care must 
be exercised in handling and transporting chemotherapy drugs. IV 
chemotherapy is administered either peripherally or more commonly given 
via an indwelling central line, which raises the risk of bloodstream 
infections. Given the significant burden of malignancy, the resource 
intensity of administering chemotherapy, and the side effects and 
potential complications of these highly-toxic medications, assessing 
the receipt of chemotherapy is important in the PAC setting for care 
planning and determining resource use. The need for chemotherapy 
predicts resource intensity, both because of the complexity of 
administering these potent, toxic drug combinations under specific 
protocols, and because of what the need for chemotherapy signals about 
the patient's underlying medical condition. Furthermore, the resource 
intensity of IV chemotherapy is higher than for oral chemotherapy, as 
the protocols for administration and the care of the central line (if 
present) for IV chemotherapy require significant resources.
    The Chemotherapy (IV, Oral, Other) data element consists of a 
principal data element (Chemotherapy) and three response option sub-
elements: IV chemotherapy, which is generally resource-intensive; Oral 
chemotherapy, which is less invasive and generally requires less 
intensive administration protocols; and a third category, Other, 
provided to enable the capture of other less common chemotherapeutic 
approaches. This third category is potentially associated with higher 
risks and is more resource intensive due to chemotherapy delivery by 
other routes (for example, intraventricular or intrathecal). If the 
assessor indicates that the patient is receiving chemotherapy on the 
principal Chemotherapy data element, the assessor would then indicate 
by which route or routes (IV, Oral, Other) the chemotherapy is 
administered.
    A single Chemotherapy data element that does not include the 
proposed three sub-elements is currently in use in the MDS in SNFs. For 
more information on the Chemotherapy (IV, Oral, Other) data element, we 
refer readers to the document titled ``Proposed Specifications for HH 
QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Chemotherapy data element was first proposed as a SPADE in the 
CY 2018 HH PPS proposed rule (82 FR 35359 through 35360). In that 
proposed rule, we stated that the proposal was informed by input we 
received through a call for input published on the CMS Measures 
Management System Blueprint website. Input submitted from August 12 to 
September 12, 2016 expressed support for the IV Chemotherapy data 
element and suggested it be included as standardized patient assessment 
data. We also stated that those commenters had noted that assessing the 
use of chemotherapy services is relevant to share across the care 
continuum to facilitate care coordination and care transitions and 
noted the validity of the data element. Commenters also noted the 
importance of capturing all types of chemotherapy, regardless of route, 
and stated that collecting data only on patients and residents who 
received chemotherapy by IV would limit the usefulness of this 
standardized data element. A summary report for the August 12 to 
September 12, 2016 public comment period titled ``SPADE August 2016 
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Chemotherapy data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Chemotherapy data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Chemotherapy data element to be feasible and reliable for use 
with PAC patients and residents. More information about the performance 
of the Chemotherapy data element in the National Beta Test can be found 
in the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the special 
services, treatments, and interventions. Although the TEP members did 
not specifically discuss the Chemotherapy data element, the TEP members 
supported the assessment of the special services, treatments, and 
interventions included in the National Beta Test with respect to both 
admission and discharge. A summary of the September 17, 2018 TEP 
meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting

[[Page 34658]]

and via email through February 1, 2019. A summary of the public input 
received from the November 27, 2018 stakeholder meeting titled ``Input 
on SPADEs Received After November 27, 2018 Stakeholder Meeting'' is 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing chemotherapy, 
stakeholder input, and strong test results, we are proposing that the 
Chemotherapy (IV, Oral, Other) data element with a principal data 
element and three sub-elements meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Chemotherapy (IV, Oral, Other) data element as standardized 
patient assessment data for use in the HH QRP.
b. Cancer Treatment: Radiation
    We are proposing that the Radiation data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35360), 
radiation is a type of cancer treatment that uses high-energy 
radioactivity to stop cancer by damaging cancer cell DNA, but it can 
also damage normal cells. Radiation is an important therapy for 
particular types of cancer, and the resource utilization is high, with 
frequent radiation sessions required, often daily for a period of 
several weeks. Assessing whether a patient or resident is receiving 
radiation therapy is important to determine resource utilization 
because PAC patients and residents will need to be transported to and 
from radiation treatments, and monitored and treated for side effects 
after receiving this intervention. Therefore, assessing the receipt of 
radiation therapy, which would compete with other care processes given 
the time burden, would be important for care planning and care 
coordination by PAC providers.
    The proposed data element consists of the single Radiation data 
element. The Radiation data element is currently in use in the MDS for 
SNFs. For more information on the Radiation data element, we refer 
readers to the document titled, ``Proposed Specifications for HH QRP 
Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Radiation data element was first proposed as a standardized 
patient assessment data element in the CY 2018 HH PPS proposed rule (82 
FR 35360). In that proposed rule, we stated that the proposal was 
informed by input we received through a call for input published on the 
CMS Measures Management System Blueprint website. Input submitted from 
August 12 to September 12, 2016 expressed support for the Radiation 
data element, noting its importance and clinical usefulness for 
patients and residents in PAC settings, due to the side effects and 
consequences of radiation treatment on patients and residents that need 
to be considered in care planning and care transitions, the feasibility 
of the item, and the potential for it to improve quality. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, we 
received public comments in support of the special services, 
treatments, and interventions data elements in general; no additional 
comments were received that were specific to the Radiation data 
element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Radiation data element was included in the National Beta Test 
of candidate data elements conducted by our data element contractor 
from November 2017 to August 2018. Results of this test found the 
Radiation data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
Radiation data element in the National Beta Test can be found in the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP members did not specifically 
discuss the Radiation data element, the TEP members supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present results of the National Beta 
Test and solicit additional comments. General input on the testing and 
item development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing radiation, stakeholder 
input, and strong test results, we are proposing that the Radiation 
data element meets the definition of standardized patient assessment 
data with respect to special services, treatments, and interventions 
under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Radiation 
data element as standardized patient assessment data for use in the HH 
QRP.
c. Respiratory Treatment: Oxygen Therapy (Intermittent, Continuous, 
High-Concentration Oxygen Delivery System)
    We are proposing that the Oxygen Therapy (Intermittent, Continuous, 
High-Concentration Oxygen Delivery System) data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35360 
through 35361), we proposed a data element

[[Page 34659]]

related to oxygen therapy. Oxygen therapy provides a patient or 
resident with extra oxygen when medical conditions such as chronic 
obstructive pulmonary disease, pneumonia, or severe asthma prevent the 
patient or resident from getting enough oxygen from breathing. Oxygen 
administration is a resource-intensive intervention, as it requires 
specialized equipment such as a source of oxygen, delivery systems (for 
example, oxygen concentrator, liquid oxygen containers, and high-
pressure systems), the patient interface (for example, nasal cannula or 
mask), and other accessories (for example, regulators, filters, 
tubing). The data element proposed here capture patient or resident use 
of three types of oxygen therapy (intermittent, continuous, and high-
concentration oxygen delivery system), which reflects the intensity of 
care needed, including the level of monitoring and bedside care 
required. Assessing the receipt of this service is important for care 
planning and resource use for PAC providers.
    The proposed data element, Oxygen Therapy, consists of the 
principal Oxygen Therapy data element and three sub-elements: 
Continuous (whether the oxygen was delivered continuously, typically 
defined as > =14 hours per day); Intermittent; or High-concentration 
oxygen delivery system. Based on public comments and input from expert 
advisors about the importance and clinical usefulness of documenting 
the extent of oxygen use, we added a third sub-element, high-
concentration oxygen delivery system, to the sub-elements, which 
previously included only intermittent and continuous. If the assessor 
indicates that the patient is receiving oxygen therapy on the principal 
oxygen therapy data element, the assessor would then indicate the type 
of oxygen the patient receives (for example, Continuous, Intermittent, 
High-concentration oxygen delivery system).
    These three proposed sub-elements were developed based on similar 
data elements that assess oxygen therapy, currently in use in the MDS 
for SNFs (``Oxygen Therapy''), previously used in the OASIS-C2 for HHAs 
(``Oxygen (intermittent or continuous)''), and a data element tested in 
the PAC PRD that focused on intensive oxygen therapy (``High O2 
Concentration Delivery System with FiO2 > 40 percent''). For more 
information on the proposed Oxygen Therapy (Continuous, Intermittent, 
High-concentration oxygen delivery system) data element, we refer 
readers to the document titled, ``Proposed Specifications for HH QRP 
Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Oxygen Therapy (Continuous, Intermittent) data element was 
first proposed as a standardized patient assessment data element in the 
CY 2018 HH PPS proposed rule (82 FR 35360 through 35361). In that 
proposed rule, we stated that the proposal was informed by input we 
received on the single data element, Oxygen (inclusive of intermittent 
and continuous oxygen use), through a call for input published on the 
CMS Measures Management System Blueprint website. Input submitted from 
August 12 to September 12, 2016 expressed the importance of the Oxygen 
data element, noting feasibility of this item in PAC, and the relevance 
of it to facilitating care coordination and supporting care 
transitions, but suggesting that the extent of oxygen use be 
documented. A summary report for the August 12 to September 12, 2016 
public comment period titled ``SPADE August 2016 Public Comment Summary 
Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Oxygen Therapy (Continuous, 
Intermittent) data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Oxygen Therapy data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Oxygen Therapy data element to be feasible and reliable for 
use with PAC patients and residents. More information about the 
performance of the Oxygen Therapy data element in the National Beta 
Test can be found in the document titled, ``Proposed Specifications for 
HH QRP Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018, although the TEP did not specifically discuss the 
Oxygen Therapy data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing oxygen therapy, 
stakeholder input, and strong test results, we are proposing that the 
Oxygen Therapy (Continuous, Intermittent, High-Concentration Oxygen 
Delivery System) data element with a principal data element and three 
sub-elements meets the definition of standardized patient assessment 
data with respect to special services, treatments, and interventions 
under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen 
(Continuous, Intermittent, High-Concentration Oxygen Delivery System) 
data element as standardized patient assessment data for use in the HH 
QRP.
d. Respiratory Treatment: Suctioning (Scheduled, As Needed)
    We are proposing that the Suctioning (Scheduled, As needed) data 
element meets the definition of standardized patient assessment data 
with respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35361 
through

[[Page 34660]]

35362), suctioning is a process used to clear secretions from the 
airway when a person cannot clear those secretions on his or her own. 
It is done by aspirating secretions through a catheter connected to a 
suction source. Types of suctioning include oropharyngeal and 
nasopharyngeal suctioning, nasotracheal suctioning, and suctioning 
through an artificial airway such as a tracheostomy tube. Oropharyngeal 
and nasopharyngeal suctioning are a key part of many patients' or 
residents' care plans, both to prevent the accumulation of secretions 
than can lead to aspiration pneumonias (a common condition in patients 
and residents with inadequate gag reflexes), and to relieve 
obstructions from mucus plugging during an acute or chronic respiratory 
infection, which often lead to desaturations and increased respiratory 
effort. Suctioning can be done on a scheduled basis if the patient is 
judged to clinically benefit from regular interventions, or can be done 
as needed when secretions become so prominent that gurgling or choking 
is noted, or a sudden desaturation occurs from a mucus plug. As 
suctioning is generally performed by a care provider rather than 
independently, this intervention can be quite resource intensive. It 
also signifies an underlying medical condition that prevents the 
patient from clearing his/her secretions effectively (such as after a 
stroke, or during an acute respiratory infection). Generally, 
suctioning is necessary to ensure that the airway is clear of 
secretions which can inhibit successful oxygenation of the individual. 
The intent of suctioning is to maintain a patent airway, the loss of 
which can lead to death, or complications associated with hypoxia.
    The Suctioning (Scheduled, As needed) data element consists of the 
principal data element, and two sub-elements: Scheduled and As needed. 
These sub-elements capture two types of suctioning. Scheduled indicates 
suctioning based on a specific frequency, such as every hour; as needed 
means suctioning only when indicated. If the assessor indicates that 
the patient is receiving suctioning on the principal Suctioning data 
element, the assessor would then indicate the frequency (Scheduled, As 
needed). The proposed data element is based on an item currently in use 
in the MDS in SNFs which does not include our proposed two sub-
elements, as well as data elements tested in the PAC PRD that focused 
on the frequency of suctioning required for patients and residents with 
tracheostomies (``Trach Tube with Suctioning: Specify most intensive 
frequency of suctioning during stay [Every _ hours]''). For more 
information on the Suctioning data element, we refer readers to the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Suctioning data element was first proposed as standardized 
patient assessment data elements in the CY 2018 HH PPS proposed rule 
(82 FR 35361 through 35362). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted from August 12 to September 12, 2016 expressed support 
for the Suctioning data element currently used in the MDS in SNFs. The 
input noted the feasibility of this item in PAC, and the relevance of 
this data element to facilitating care coordination and supporting care 
transitions. We also stated that those commenters had suggested that we 
examine the frequency of suctioning to better understand the use of 
staff time, the impact on a patient or resident's capacity to speak and 
swallow, and intensity of care required. Based on these comments, we 
decided to add two sub-elements (Scheduled and As needed) to the 
suctioning element. The proposed Suctioning data element includes both 
the principal Suctioning data element that is included on the MDS in 
SNFs and two sub-elements, Scheduled and As needed. A summary report 
for the August 12 to September 12, 2016 public comment period titled 
``SPADE August 2016 Public Comment Summary Report'' is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Suctioning data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Suctioning data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Suctioning data element to be feasible and reliable for use 
with PAC patients and residents. More information about the performance 
of the Suctioning data element in the National Beta Test can be found 
in the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Suctioning data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicited additional comments. General input on the 
testing and item development process and concerns about burden were 
received from stakeholders during this meeting and via email through 
February 1, 2019. A summary of the public input received from the 
November 27, 2018 stakeholder meeting titled ``Input on SPADEs Received 
After November 27, 2018 Stakeholder Meeting'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing suctioning, stakeholder 
input, and strong test results, we are proposing that the Suctioning 
(Scheduled, As needed) data element with a principal data element and 
two sub-elements meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act and to

[[Page 34661]]

adopt the Suctioning (Scheduled, As needed) data element as 
standardized patient assessment data for use in the HH QRP.
e. Respiratory Treatment: Tracheostomy Care
    We are proposing that the Tracheostomy Care data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35362), a 
tracheostomy provides an air passage to help a patient or resident 
breathe when the usual route for breathing is obstructed or impaired. 
Generally, in all of these cases, suctioning is necessary to ensure 
that the tracheostomy is clear of secretions, which can inhibit 
successful oxygenation of the individual. Often, individuals with 
tracheostomies are also receiving supplemental oxygenation. The 
presence of a tracheostomy, albeit permanent or temporary, warrants 
careful monitoring and immediate intervention if the tracheostomy 
becomes occluded or if the device used becomes dislodged. While in rare 
cases the presence of a tracheostomy is not associated with increased 
care demands (and in some of those instances, the care of the ostomy is 
performed by the patient) in general the presence of such as device is 
associated with increased patient risk, and clinical care services will 
necessarily include close monitoring to ensure that no life-threatening 
events occur as a result of the tracheostomy. In addition, tracheostomy 
care, which primarily consists of cleansing, dressing changes, and 
replacement of the tracheostomy cannula is also a critical part of the 
care plan. Regular cleansing is important to prevent infection such as 
pneumonia and to prevent any occlusions with which there are risks for 
inadequate oxygenation.
    The proposed data element consists of the single Tracheostomy Care 
data element. The proposed data element is currently in use in the MDS 
for SNFs (``Tracheostomy care''). For more information on the 
Tracheostomy Care data element, we refer readers to the document titled 
``Proposed Specifications for HH QRP Quality Measures and SPADEs'', 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Tracheostomy Care data element was first proposed as a 
standardized patient assessment data element in the CY 2018 HH PPS 
proposed rule (82 FR 35362). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted on the Tracheostomy Care data element from August 12 to 
September 12, 2016 supported this data element, noting the feasibility 
of this item in PAC, and the relevance of this data element to 
facilitating care coordination and supporting care transitions. A 
summary report for the August 12 to September 12, 2016 public comment 
period titled ``SPADE August 2016 Public Comment Summary Report'' is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Tracheostomy Care data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Tracheostomy Care data element was included in the National 
Beta Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Tracheostomy Care data element to be feasible and reliable 
for use with PAC patients and residents. More information about the 
performance of the Tracheostomy Care data element in the National Beta 
Test can be found in the document titled, ``Proposed Specifications for 
HH QRP Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Tracheostomy Care data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing tracheostomy care, 
stakeholder input, and strong test results, we are proposing that the 
Tracheostomy Care data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Tracheostomy Care data element as standardized patient 
assessment data for use in the HH QRP.
f. Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP, 
CPAP)
    We are proposing that the Non-invasive Mechanical Ventilator 
(Bilevel Positive Airway Pressure [BiPAP], Continuous Positive Airway 
Pressure [CPAP]) data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35362 
through 35363), BiPAP and CPAP are respiratory support devices that 
prevent the airways from closing by delivering slightly pressurized air 
via electronic cycling throughout the breathing cycle (BiPAP) or 
through a mask continuously (CPAP). Assessment of non-invasive 
mechanical ventilation is important in care planning, as both CPAP and 
BiPAP are resource-intensive (although less so than invasive mechanical 
ventilation) and signify underlying medical conditions about the 
patient or resident

[[Page 34662]]

who requires the use of this intervention. Particularly when used in 
settings of acute illness or progressive respiratory decline, 
additional staff (for example, respiratory therapists) are required to 
monitor and adjust the CPAP and BiPAP settings and the patient or 
resident may require more nursing resources.
    The proposed data element, Non-invasive Mechanical Ventilator 
(BIPAP, CPAP), consists of the principal Non-invasive Mechanical 
Ventilator data element and two response option sub-elements: BiPAP and 
CPAP. If the assessor indicates that the patient is receiving non-
invasive mechanical ventilation on the principal Non-invasive 
Mechanical Ventilator data element, the assessor would then indicate 
which type (BIPAP, CPAP). Data elements that assess non-invasive 
mechanical ventilation are currently included on LCDS for the LTCH 
setting (``Non-invasive Ventilator (BIPAP, CPAP)''), and the MDS for 
the SNF setting (``Non-invasive Mechanical Ventilator (BiPAP/CPAP)''). 
For more information on the Non-invasive Mechanical Ventilator data 
element, we refer readers to the document titled, ``Proposed 
Specifications for HH QRP Quality Measures and SPADEs'', available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Non-invasive Mechanical Ventilator data element was first 
proposed as a standardized patient assessment data element in the CY 
2018 HH PPS proposed rule (82 FR 35362 through 35363). In that proposed 
rule, we stated that the proposal was informed by input we received 
from August 12 to September 12, 2016 on a single data element, BiPAP/
CPAP, that captures equivalent clinical information but uses a 
different label than the data element currently used in the MDS in SNFs 
and LCDS in LTCHs, expressing support for this data element, noting the 
feasibility of these items in PAC, and the relevance of this data 
element for facilitating care coordination and supporting care 
transitions. In addition, we also stated that some commenters supported 
separating out BiPAP and CPAP as distinct sub-elements, as they are 
therapies used for different types of patients and residents. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Non-invasive Mechanical 
Ventilator data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Non-invasive Mechanical Ventilator data element was included 
in the National Beta Test of candidate data elements conducted by our 
data element contractor from November 2017 to August 2018. Results of 
this test found the Non-invasive Mechanical Ventilator data element to 
be feasible and reliable for use with PAC patients and residents. More 
information about the performance of the Non-invasive Mechanical 
Ventilator data element in the National Beta Test can be found in the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Non-invasive Mechanical Ventilator data element, the TEP supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing non-invasive mechanical 
ventilation, stakeholder input, and strong test results, we are 
proposing that the Non-invasive Mechanical Ventilator (BiPAP, CPAP) 
data element with a principal data element and two sub-elements meets 
the definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical 
Ventilator (BiPAP, CPAP) data element as standardized patient 
assessment data for use in the HH QRP.
g. Respiratory Treatment: Invasive Mechanical Ventilator
    We are proposing that the Invasive Mechanical Ventilator data 
element meets the definition of standardized patient assessment data 
with respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35363 
through 35364), invasive mechanical ventilation includes ventilators 
and respirators that ventilate the patient through a tube that extends 
via the oral airway into the pulmonary region or through a surgical 
opening directly into the trachea. Thus, assessment of invasive 
mechanical ventilation is important in care planning and risk 
mitigation. Ventilation in this manner is a resource-intensive therapy 
associated with life-threatening conditions without which the patient 
or resident would not survive. However, ventilator use has inherent 
risks requiring close monitoring. Failure to adequately care for the 
patient or resident who is ventilator dependent can lead to iatrogenic 
events such as death, pneumonia and sepsis. Mechanical ventilation 
further signifies the complexity of the patient's underlying medical or 
surgical condition. Of note, invasive mechanical ventilation is 
associated with high daily and aggregate costs.\103\
---------------------------------------------------------------------------

    \103\ Wunsch, H., Linde-Zwirble, W.T., Angus, D.C., Hartman, 
M.E., Milbrandt, E.B., & Kahn, J.M. (2010). ``The epidemiology of 
mechanical ventilation use in the United States.'' Critical Care Med 
38(10): 1947-1953.
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    The proposed data element, Invasive Mechanical Ventilator, consists 
of a

[[Page 34663]]

single data element. Data elements that capture invasive mechanical 
ventilation are currently in use in the MDS in SNFs and LCDS in LTCHs. 
For more information on the Invasive Mechanical Ventilator data 
element, we refer readers to the document titled, ``Proposed 
Specifications for HH QRP Quality Measures and SPADEs, available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Invasive Mechanical Ventilator data element was first proposed 
as a SPADE in the CY 2018 HH PPS proposed rule (82 FR 35363 through 
35364). In that proposed rule, we stated that the proposal was informed 
by input we received through a call for input published on the CMS 
Measures Management System Blueprint website. Input submitted on data 
elements that assess invasive ventilator use and weaning status that 
were tested in the PAC PRD (``Ventilator--Weaning'' and ``Ventilator--
Non-Weaning'') from August 12 to September 12, 2016 expressed support 
for this data element, highlighting the importance of this information 
in supporting care coordination and care transitions. We also stated 
that some commenters had expressed concern about the appropriateness 
for standardization given: The prevalence of ventilator weaning across 
PAC providers; the timing of administration; how weaning is defined; 
and how weaning status in particular relates to quality of care. These 
public comments guided our decision to propose a single data element 
focused on current use of invasive mechanical ventilation only, which 
does not attempt to capture weaning status. A summary report for the 
August 12 to September 12, 2016 public comment period titled ``SPADE 
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Invasive Mechanical Ventilator 
data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Invasive Mechanical Ventilator data element was included in 
the National Beta Test of candidate data elements conducted by our data 
element contractor from November 2017 to August 2018. Results of this 
test found the Invasive Mechanical Ventilator data element to be 
feasible and reliable for use with PAC patients and residents. More 
information about the performance of the Invasive Mechanical Ventilator 
data element in the National Beta Test can be found in the document 
titled, ``Proposed Specifications for HH QRP Quality Measures and 
SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Invasive Mechanical Ventilator data element, the TEP supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present results of the National Beta 
Test and solicit additional comments. General input on the testing and 
item development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing invasive mechanical 
ventilation, stakeholder input, and strong test results, we are 
proposing that the Invasive Mechanical Ventilator data element meets 
the definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act and to adopt the Invasive Mechanical 
Ventilator data element as standardized patient assessment data for use 
in the HH QRP.
h. Intravenous (IV) Medications (Antibiotics, Anticoagulants, 
Vasoactive Medications, Other)
    We are proposing that the IV Medications (Antibiotics, 
Anticoagulants, Vasoactive Medications, Other) data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35364 
through 35365), when we proposed a similar set of data elements related 
to IV medications, IV medications are solutions of a specific 
medication (for example, antibiotics, anticoagulants) administered 
directly into the venous circulation via a syringe or intravenous 
catheter. IV medications are administered via intravenous push, single, 
intermittent, or continuous infusion through a tube placed into the 
vein. Further, IV medications are more resource intensive to administer 
than oral medications, and signify a higher patient complexity (and 
often higher severity of illness). The clinical indications for each of 
the sub-elements of the IV Medications data elements (Antibiotics, 
Anticoagulants, Vasoactive Medications, and Other) are very different. 
IV antibiotics are used for severe infections when: The bioavailability 
of the oral form of the medication would be inadequate to kill the 
pathogen; an oral form of the medication does not exist; or the patient 
is unable to take the medication by mouth. IV anticoagulants refer to 
anti-clotting medications (that is, ``blood thinners''). IV 
anticoagulants are commonly used for hospitalized patients who have 
deep venous thrombosis, pulmonary embolism, or myocardial infarction, 
as well as those undergoing interventional cardiac procedures. 
Vasoactive medications refer to the IV administration of vasoactive 
drugs, including vasopressors, vasodilators, and continuous medication 
for pulmonary edema, which increase or decrease blood pressure or heart 
rate. The indications, risks, and benefits of each of these classes of 
IV medications are distinct, making it important to assess each 
separately in PAC. Knowing whether or not patients and residents are 
receiving IV medication and the type

[[Page 34664]]

of medication provided by each PAC provider will improve quality of 
care.
    The IV Medications (Antibiotics, Anticoagulants, Vasoactive 
Medications, and Other) data element we are proposing consists of a 
principal data element (IV Medications) and four response option sub-
elements: Antibiotics, Anticoagulants, Vasoactive Medications, and 
Other. The Vasoactive Medications sub-element was not proposed in the 
CY 2018 HH PPS proposed rule (82 FR 35364 through 35365). We added the 
Vasoactive Medications sub-element to our proposal in order to 
harmonize the proposed IV Mediciations element with the data currently 
collected in the LCDS.
    If the assessor indicates that the patient is receiving IV 
medications on the principal IV Medications data element, the assessor 
would then indicate which types of medications (Antibiotics, 
Anticoagulants, Vasoactive Medications, Other). An IV Medications data 
element is currently in use on the MDS in SNFs and there is a related 
data element in OASIS that collects information on Intravenous and 
Infusion Therapies. For more information on the IV Medications data 
element, we refer readers to the document titled, ``Proposed 
Specifications for HH QRP Quality Measures and SPADEs, available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    An IV Medications data element was first proposed as standardized 
patient assessment data elements in the CY 2018 HH PPS proposed rule 
(82 FR 35364 through 35365). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted on Vasoactive Medications from August 12 to September 
12, 2016 supported this data element with one commenter noting the 
importance of this data element in supporting care transitions. We also 
stated that those commenters had criticized the need for collecting 
specifically Vasoactive Medications, giving feedback that the data 
element was too narrowly focused. In addition, public comment received 
indicated that the clinical significance of vasoactive medications 
administration alone was not high enough in PAC to merit mandated 
assessment, noting that related and more useful information could be 
captured in an item that assessed all IV medication use. A summary 
report for the August 12 to September 12, 2016 public comment period 
titled ``SPADE August 2016 Public Comment Summary Report'' is available 
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for IV Medications data elements.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the IV Medications data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the IV Medications data element to be feasible and reliable for 
use with PAC patients and residents. More information about the 
performance of the IV Medications data element in the National Beta 
Test can be found in the document titled, ``Proposed Specifications for 
HH QRP Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
IV Medications data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing IV medications, 
stakeholder input, and strong test results, we are proposing that the 
IV Medications (Antibiotics, Anticoagulation, Vasoactive Medications, 
Other) data element with a principal data element and four sub-elements 
meets the definition of standardized patient assessment data with 
respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications 
(Antibiotics, Anticoagulants, Vasoactive Medications, Other) data 
element as standardized patient assessment data for use in the HH QRP.
i. Transfusions
    We are proposing that the Transfusions data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35365), 
transfusion refers to introducing blood, blood products, or other fluid 
into the circulatory system of a person. Blood transfusions are based 
on specific protocols, with multiple safety checks and monitoring 
required during and after the infusion in case of adverse events. 
Coordination with the provider's blood bank is necessary, as well as 
documentation by clinical staff to ensure compliance with regulatory 
requirements. In addition, the need for transfusions signifies 
underlying patient complexity that is likely to require care 
coordination and patient monitoring, and impacts planning for 
transitions of care, as transfusions are not performed by all PAC 
providers.
    The proposed data element consists of a single Transfusions data 
element. A data element on transfusion is currently in use in the MDS 
in SNFs (``Transfusions'') and a data element tested in the PAC PRD 
(``Blood Transfusions'') was found feasible for use in each of the four 
PAC settings. For more information on the Transfusions data element, we 
refer readers to the

[[Page 34665]]

document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Transfusions data element was first proposed as a standardized 
patient assessment data element in the CY 2018 HH PPS proposed rule (82 
FR 35365).
    In response to our proposal in the CY 2018 HH PPS proposed rule, we 
received public comments in support of the special services, 
treatments, and interventions data elements in general; no additional 
comments were received that were specific to the Transfusions data 
element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Transfusions data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Transfusions data element to be feasible and reliable for use 
with PAC patients and residents. More information about the performance 
of the Transfusions data element in the National Beta Test can be found 
in the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Transfusions data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing transfusions, 
stakeholder input, and strong test results, we are proposing that the 
Transfusions data element that is currently in use in the MDS meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act and to adopt the Transfusions data 
element as standardized patient assessment data for use in the HH QRP.
j. Dialysis (Hemodialysis, Peritoneal Dialysis)
    We are proposing that the Dialysis (Hemodialysis, Peritoneal 
Dialysis) data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35365 
through 35366), dialysis is a treatment primarily used to provide 
replacement for lost kidney function. Both forms of dialysis 
(hemodialysis and peritoneal dialysis) are resource intensive, not only 
during the actual dialysis process but before, during and following. 
Patients and residents who need and undergo dialysis procedures are at 
high risk for physiologic and hemodynamic instability from fluid shifts 
and electrolyte disturbances as well as infections that can lead to 
sepsis. Further, patients or residents receiving hemodialysis are often 
transported to a different facility, or at a minimum, to a different 
location in the same facility. Close monitoring for fluid shifts, blood 
pressure abnormalities, and other adverse effects is required prior to, 
during and following each dialysis session. Nursing staff typically 
perform peritoneal dialysis at the bedside, and as with hemodialysis, 
close monitoring is required.
    The proposed data element, Dialysis (Hemodialysis, Peritoneal 
Dialysis) consists of the principal Dialysis data element and two 
response option sub-elements: Hemodialysis and Peritoneal Dialysis. If 
the assessor indicates that the patient is receiving dialysis on the 
principal Dialysis data element, the assessor would then indicate which 
type (Hemodialysis, Peritoneal Dialysis). The principal Dialysis data 
element is currently included on the MDS in SNFs and the LCDS for LTCHs 
and assesses the overall use of dialysis. As the result of public 
feedback described, in this proposed rule, we are proposing data 
elements that include the principal Dialysis data element and two sub-
elements (Hemodialysis and Peritoneal Dialysis). For more information 
on the Dialysis data element, we refer readers to the document titled, 
``Proposed Specifications for HH QRP Quality Measures and SPADEs'', 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Dialysis data element was first proposed as standardized 
patient assessment data elements in the CY 2018 HH PPS proposed rule 
(82 FR 35365 through 35366). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted on a singular Hemodialysis data element from August 12 
to September 12, 2016 supported the assessment of hemodialysis and 
recommended that the data element be expanded to include peritoneal 
dialysis. We also stated that those commenters had supported the 
singular Hemodialysis data element, noting the relevance of this 
information for sharing across the care continuum to facilitate care 
coordination and care transitions, the potential for this data element 
to be used to improve quality, and the feasibility for use in PAC. In 
addition, we received comment that the item would be useful in 
improving patient and resident transitions of care. We also noted that 
several commenters had stated that peritoneal dialysis should be 
included in a standardized data element on dialysis and recommended 
collecting information on peritoneal dialysis in addition to 
hemodialysis. The rationale for including peritoneal dialysis from 
commenters included the fact that patients and residents receiving 
peritoneal dialysis will have different

[[Page 34666]]

needs at post-acute discharge compared to those receiving hemodialysis 
or not having any dialysis. Based on these comments, the Hemodialysis 
data element was expanded to include a principal Dialysis data element 
and two sub-elements, Hemodialysis and Peritoneal Dialysis. We are 
proposing the expanded version of the Dialysis data element that 
includes two types of dialysis. A summary report for the August 12 to 
September 12, 2016 public comment period titled ``SPADE August 2016 
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, we 
received public comments in support of the special services, 
treatments, and interventions data elements in general; no additional 
comments were received that were specific to the Dialysis data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Dialysis data element was included in the National Beta Test 
of candidate data elements conducted by our data element contractor 
from November 2017 to August 2018. Results of this test found the 
Dialysis data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
Dialysis data element in the National Beta Test can be found in the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although they did not specifically discuss the 
Dialysis data element, the TEP supported the assessment of the special 
services, treatments, and interventions included in the National Beta 
Test with respect to both admission and discharge. A summary of the 
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel 
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing dialysis, stakeholder 
input, and strong test results, we are proposing that the Dialysis 
(Hemodialysis, Peritoneal Dialysis) data element with a principal data 
element and two sub-elements meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Dialysis (Hemodialysis, Peritoneal Dialysis) data element as 
standardized patient assessment data for use in the HH QRP.
k. Intravenous (IV) Access (Peripheral IV, Midline, Central Line)
    We are proposing that the IV Access (Peripheral IV, Midline, 
Central Line) data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35366), 
patients or residents with central lines, including those peripherally 
inserted or who have subcutaneous central line ``port'' access, always 
require vigilant nursing care to keep patency of the lines and ensure 
that such invasive lines remain free from any potentially life-
threatening events such as infection, air embolism, or bleeding from an 
open lumen. Clinically complex patients and residents are likely to be 
receiving medications or nutrition intravenously. The sub-elements 
included in the IV Access data element distinguish between peripheral 
access and different types of central access. The rationale for 
distinguishing between a peripheral IV and central IV access is that 
central lines confer higher risks associated with life-threatening 
events such as pulmonary embolism, infection, and bleeding.
    The proposed data element, IV Access (Peripheral IV, Midline, 
Central Line), consists of the principal IV Access data element and 
three response option sub-elements: Peripheral IV, Midline, and Central 
Line. The proposed IV Access data element is not currently included on 
any of the PAC assessment instruments, although there is a related 
response option in the M1030 data element in the OASIS. We are 
proposing to replace the existing ``Intravenous or Infusion Therapy'' 
response option of the M1030 data element in the OASIS with the IV 
Access (Peripheral IV, Midline, Central Line) data element. For more 
information on the IV Access data element, we refer readers to the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The IV Access data element was first proposed as standardized 
patient assessment data elements in the CY 2018 HH PPS proposed rule 
(82 FR 35366). In that proposed rule, we stated that the proposal was 
informed by input we received through a call for input published on the 
CMS Measures Management System Blueprint website. Input was submitted 
on one of the PAC PRD data elements, Central Line Management, from 
August 12 to September 12, 2016. A central line is one type of IV 
access. We stated that those commenters had supported the assessment of 
central line management and recommended that the data element be 
broadened to also include other types of IV access. Several commenters 
noted feasibility and importance of facilitating care coordination and 
care transitions. However, a few commenters recommended that the 
definition of this data element be broadened to include peripherally 
inserted central catheters (``PICC lines'') and midline IVs. Based on 
public comment feedback and in consultation with expert input, 
described elsewhere in this proposed rule, we created an overarching IV 
Access data element with sub-elements for other types of IV access in 
addition to central lines (that is, peripheral IV and midline). This 
expanded version of IV Access is the data element being proposed. A 
summary report for the

[[Page 34667]]

August 12 to September 12, 2016 public comment period titled ``SPADE 
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the IV Access data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the IV Access data element was included in the National Beta Test 
of candidate data elements conducted by our data element contractor 
from November 2017 to August 2018. Results of this test found the IV 
Access data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
IV Access data element in the National Beta Test can be found in the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
IV Access data element, the TEP supported the assessment of the special 
services, treatments, and interventions included in the National Beta 
Test with respect to both admission and discharge. A summary of the 
September 17, 2018 TEP meeting titled ``SPADE Technical Expert Panel 
Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present results of the National Beta 
Test and solicit additional comments. General input on the testing and 
item development process and concerns about burden were received from 
stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing IV access, stakeholder 
input, and strong test results, we are proposing that the IV access 
(Peripheral IV, Midline, Central Line) data element with a principal 
data element and three sub-elements meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the IV Access (Peripheral IV, Midline, Central Line) 
data element as standardized patient assessment data for use in the HH 
QRP.
l. Nutritional Approach: Parenteral/IV Feeding
    We are proposing that the Parenteral/IV Feeding data element meets 
the definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35366 
through 35367), parenteral nutrition/IV feeding refers to a patient or 
resident being fed intravenously using an infusion pump, bypassing the 
usual process of eating and digestion. The need for parenteral 
nutrition/IV feeding indicates a clinical complexity that prevents the 
patient or resident from meeting his or her nutritional needs 
internally, and is more resource intensive than other forms of 
nutrition, as it often requires monitoring of blood chemistries and 
maintenance of a central line. Therefore, assessing a patient's or 
resident's need for parenteral feeding is important for care planning 
and resource use. In addition to the risks associated with central and 
peripheral intravenous access, total parenteral nutrition is associated 
with significant risks such as embolism and sepsis.
    The proposed data element consists of the single Parenteral/IV 
Feeding data element. The proposed Parenteral/IV Feeding data element 
is currently in use in the MDS for SNFs, and equivalent or related data 
elements are in use in the LCDS, IRF-PAI, and OASIS. We are proposing 
to replace the existing ``Parenteral nutrition (TPN or lipids)'' 
response option of the M1030 data element in the OASIS with the 
proposed Parenteral/IV Feeding data element. For more information on 
the Parenteral/IV Feeding data element, we refer readers to the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Parenteral/IV Feeding data element was first proposed as a 
standardized patient assessment data element in the CY 2018 HH PPS 
proposed rule (82 FR 35366 through 35367). In that proposed rule, we 
stated that the proposal was informed by input we received through a 
call for input published on the CMS Measures Management System 
Blueprint website. Input submitted on Total Parenteral Nutrition (an 
item with nearly the same meaning as the proposed data element, but 
with the label used in the PAC PRD), which was included in a call for 
public input from August 12 to September 12, 2016. We stated that 
commenters had supported this data element, noting its relevance to 
facilitating care coordination and supporting care transitions. After 
the public comment period, the Total Parenteral Nutrition data element 
was renamed Parenteral/IV Feeding, to be consistent with how this data 
element is referred to in the MDS in SNFs. A summary report for the 
August 12 to September 12, 2016 public comment period titled ``SPADE 
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. In response to our proposal in 
the CY 2018 HH PPS proposed rule, two commenters expressed support for 
the Parenteral/IV Feeding data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Parenteral/IV Feeding data element was included in the 
National Beta Test of candidate data elements conducted by our data 
element contractor from November 2017 to August 2018. Results of this 
test found the Parenteral/IV Feeding data element to be feasible and 
reliable for use with PAC patients and residents. More information 
about the performance of the Parenteral/IV Feeding data element in the 
National Beta Test can be found in the document titled, ``Proposed 
Specifications for HH QRP Quality Measures and SPADEs, available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-

[[Page 34668]]

Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-
of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Parenteral/IV Feeding data element, the TEP supported the assessment of 
the special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing parenteral/IV feeding, 
stakeholder input, and strong test results, we are proposing that the 
Parenteral/IV Feeding data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Parenteral/IV Feeding data element as standardized patient 
assessment data for use in the HH QRP.
m. Nutritional Approach: Feeding Tube
    We are proposing that the Feeding Tube data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35367 
through 35368), the majority of patients admitted to acute care 
hospitals experience deterioration of their nutritional status during 
their hospital stay, making assessment of nutritional status and method 
of feeding if unable to eat orally very important in PAC. A feeding 
tube can be inserted through the nose or the skin on the abdomen to 
deliver liquid nutrition into the stomach or small intestine. Feeding 
tubes are resource intensive and, therefore, are important to assess 
for care planning and resource use. Patients with severe malnutrition 
are at higher risk for a variety of complications.\104\ In PAC 
settings, there are a variety of reasons that patients and residents 
may not be able to eat orally (including clinical or cognitive status).
---------------------------------------------------------------------------

    \104\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The 
link between nutritional status and clinical outcome: Can 
nutritional intervention modify it?'' Am J of Clinical Nutrition, 
47(2): 352-356.
---------------------------------------------------------------------------

    The proposed data element consists of the single Feeding Tube data 
element. The Feeding Tube data element is currently included in the MDS 
for SNFs, and in the OASIS for HHAs, where it is labeled ``Enteral 
Nutrition (nasogastric, gastrostomy, jejunostomy, or any other 
artificial entry into the alimentary canal)''. A related data element, 
collected in the IRF-PAI for IRFs (Tube/Parenteral Feeding), assesses 
use of both feeding tubes and parenteral nutrition. We are proposing to 
rename ``Enteral nutrition (nasogastric, gastrostomy, jejunostomy, or 
any other artificial entry into the alimentary canal)'' data element to 
``Feeding Tube,'' and adopt it as a SPADE for the HH QRP. For more 
information on the Feeding Tube data element, we refer readers to the 
document titled, ``Proposed Specifications for HH QRP Quality Measures 
and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Feeding Tube data element was first proposed as a standardized 
patient assessment data element in the CY 2018 HH PPS proposed rule (82 
FR 35367 through 35368). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted on an Enteral Nutrition data element (which is the same 
as the data element we are proposing in this proposed rule, but is used 
in the OASIS under a different name) from August 12 to September 12, 
2016 supported the data element, noting the importance of assessing 
enteral nutrition status for facilitating care coordination and care 
transitions. After the public comment period, the Enteral Nutrition 
data element used in public comment was renamed Feeding Tube, 
indicating the presence of an assistive device. A summary report for 
the August 12 to September 12, 2016 public comment period titled 
``SPADE August 2016 Public Comment Summary Report'' is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, a 
few commenters expressed support for the Feeding Tube data element. A 
commenter also recommended that the term ``enteral feeding'' be used 
instead of ``feeding tube.''
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Feeding Tube data element was included in the National Beta 
Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Feeding Tube data element to be feasible and reliable for use 
with PAC patients and residents. More information about the performance 
of the Feeding Tube data element in the National Beta Test can be found 
in the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Feeding Tube data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-

[[Page 34669]]

2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing feeding tubes, 
stakeholder input, and strong test results, we are proposing that the 
Feeding Tube data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt 
the Feeding Tube data element as standardized patient assessment data 
for use in the HH QRP.
n. Nutritional Approach: Mechanically Altered Diet
    We are proposing that the Mechanically Altered Diet data element 
meets the definition of standardized patient assessment data with 
respect to special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35368), the 
Mechanically Altered Diet data element refers to food that has been 
altered to make it easier for the patient or resident to chew and 
swallow, and this type of diet is used for patients and residents who 
have difficulty performing these functions. Patients with severe 
malnutrition are at higher risk for a variety of complications.\105\
---------------------------------------------------------------------------

    \105\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The 
link between nutritional status and clinical outcome: Can 
nutritional intervention modify it?'' Am J of Clinical Nutrition, 
47(2): 352-356.
---------------------------------------------------------------------------

    In PAC settings, there are a variety of reasons that patients and 
residents may have impairments related to oral feedings, including 
clinical or cognitive status. The provision of a mechanically altered 
diet may be resource intensive, and can signal difficulties associated 
with swallowing/eating safety, including dysphagia. In other cases, it 
signifies the type of altered food source, such as ground or puree that 
will enable the safe and thorough ingestion of nutritional substances 
and ensure safe and adequate delivery of nourishment to the patient. 
Often, patients and residents on mechanically altered diets also 
require additional nursing supports such as individual feeding, or 
direct observation, to ensure the safe consumption of the food product. 
Assessing whether a patient or resident requires a mechanically altered 
diet is therefore important for care planning and resource 
identification.
    The proposed data element consists of the single Mechanically 
Altered Diet data element. The proposed data element for a mechanically 
altered diet is currently included on the MDS for SNFs. A related data 
element for modified food consistency/supervision is currently included 
on the IRF-PAI for IRFs. Another related data element is included in 
the OASIS for HHAs that collects information about independent eating 
that requires ``a liquid, pureed or ground meat diet.'' For more 
information on the Mechanically Altered Diet data element, we refer 
readers to the document titled, ``Proposed Specifications for HH QRP 
Quality Measures and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Mechanically Altered Diet data element was first proposed as a 
standardized patient assessment data element in the CY 2018 HH PPS 
proposed rule (82 FR 35368).
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Mechanically Altered Diet data 
element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Mechanically Altered Diet data element was included in the 
National Beta Test of candidate data elements conducted by our data 
element contractor from November 2017 to August 2018. Results of this 
test found the Mechanically Altered Diet data element to be feasible 
and reliable for use with PAC patients and residents. More information 
about the performance of the Mechanically Altered Diet data element in 
the National Beta Test can be found in the document titled, ''Proposed 
Specifications for HH QRP Quality Measures and SPADEs, available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Mechanically Altered Diet data element, the TEP supported the 
assessment of the special services, treatments, and interventions 
included in the National Beta Test with respect to both admission and 
discharge. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing mechanically altered 
diet, stakeholder input, and strong test results, we are proposing that 
the Mechanically Altered Diet data element meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the Mechanically Altered Diet data element as 
standardized patient assessment data for use in the HH QRP.

[[Page 34670]]

o. Nutritional Approach: Therapeutic Diet
    We are proposing that the Therapeutic Diet data element meets the 
definition of standardized patient assessment data with respect to 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35368 
through 35369), a therapeutic diet refers to meals planned to increase, 
decrease, or eliminate specific foods or nutrients in a patient's or 
resident's diet, such as a low-salt diet, for the purpose of treating a 
medical condition. The use of therapeutic diets among patients and 
residents in PAC provides insight on the clinical complexity of these 
patients and residents and their multiple comorbidities. Therapeutic 
diets are less resource intensive from the bedside nursing perspective, 
but do signify one or more underlying clinical conditions that preclude 
the patient from eating a regular diet. The communication among PAC 
providers about whether a patient is receiving a particular therapeutic 
diet is critical to ensure safe transitions of care.
    The proposed data element consists of the single Therapeutic Diet 
data element. The Therapeutic Diet data element is currently in use in 
the MDS for SNFs. For more information on the Therapeutic Diet data 
element, we refer readers to the document titled, ``Proposed 
Specifications for HH QRP Quality Measures and SPADEs,'' available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Therapeutic Diet data element was first proposed as a 
standardized patient assessment data element in the CY 2018 HH PPS 
proposed rule (82 FR 35368 through 35369).
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter expressed support for the Therapeutic Diet data element 
and encouraged CMS to align with the Academy of Nutrition and Dietetics 
definition of ``therapeutic diet.''
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Therapeutic Diet data element was included in the National 
Beta Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Therapeutic Diet data element to be feasible and reliable for 
use with PAC patients and residents. More information about the 
performance of the Therapeutic Diet data element in the National Beta 
Test can be found in the document titled, ``Proposed Specifications for 
HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. Although the TEP did not specifically discuss the 
Therapeutic Diet data element, the TEP supported the assessment of the 
special services, treatments, and interventions included in the 
National Beta Test with respect to both admission and discharge. A 
summary of the September 17, 2018 TEP meeting titled ``SPADE Technical 
Expert Panel Summary (Third Convening)'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. A summary of the public input received from the November 27, 2018 
stakeholder meeting titled ``Input on SPADEs Received After November 
27, 2018 Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing therapeutic diet, 
stakeholder input, and strong test results, we are proposing that the 
Therapeutic Diet data element meets the definition of standardized 
patient assessment data with respect to special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act and to 
adopt the Therapeutic data element as standardized patient assessment 
data for use in the HH QRP.
p. High-Risk Drug Classes: Use and Indication
    We are proposing that the High-Risk Drug Classes: Use and 
Indication data element meets the definition of standardized patient 
assessment data with respect to special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act.
    Most patients and residents receiving PAC services depend on short- 
and long-term medications to manage their medical conditions. However, 
as a treatment, medications are not without risk; medications are in 
fact a leading cause of adverse events. A study by the U.S. Department 
of Health and Human Services found that 31 percent of adverse events 
that occurred in 2008 among hospitalized Medicare beneficiaries were 
related to medication.\106\ Moreover, changes in a patient's condition, 
medications, and transitions between care settings put patients and 
residents at risk of medication errors and adverse drug events (ADEs). 
ADEs may be caused by medication errors such as drug omissions, errors 
in dosage, and errors in dosing frequency.\107\
---------------------------------------------------------------------------

    \106\ U.S. Department of Health and Human Services. Office of 
Inspector General. Daniel R. Levinson. Adverse Events in Hospitals: 
National Incidence Among Medicare Beneficiaries. OEI-06-09-00090. 
November 2010.
    \107\ Boockvar KS, Liu S, Goldstein N, Nebeker J, Siu A, Fried 
T. Prescribing discrepancies likely to cause adverse drug events 
after patient transfer. Qual Saf Health Care. 2009;18(1):32-6.
---------------------------------------------------------------------------

    ADEs are known to occur across different types of healthcare. For 
example, the incidence of ADEs in the outpatient setting has been 
estimated at 1.15 ADEs per 100 person-months,\108\ while the rate of 
ADEs in the long-term care setting is approximately 9.80 ADEs per 100 
resident-months.\109\ In the hospital setting, the incidence has been 
estimated at 15 ADEs per 100 admissions.\110\ In addition, 
approximately half of all hospital-related medication errors and 20 
percent of ADEs occur during transitions within, admission to, transfer 
to, or discharge

[[Page 34671]]

from a hospital.\111,112,113\ ADEs are more common among older adults, 
who make up most patients and residents receiving PAC services. The 
rate of emergency department visits for ADEs is three times higher 
among adults 65 years of age and older compared to that among those 
younger than age 65.\114\
---------------------------------------------------------------------------

    \108\ Gandhi TK, Seger AC, Overhage JM, et al. Outpatient 
adverse drug events identified by screening electronic health 
records. J Patient Saf 2010;6:91-6. doi:10.1097/
PTS.0b013e3181dcae06.
    \109\ Gurwitz JH, Field TS, Judge J, Rochon P, Harrold LR, 
Cadoret C, et al. The incidence of adverse drug events in two large 
academic long-term care facilities. Am J Med. 2005; 118(3):2518. Epub 2005/03/05. https://doi.org/10.1016/j.amjmed.2004.09.018. PMID: 15745723.
    \110\ Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon 
C, Matheny ME, Bates DW. Occurrence of adverse, often preventable, 
events in community hospitals involving nephrotoxic drugs or those 
excreted by the kidney. Kidney Int. 2009; 76:1192-1198. [PubMed: 
19759525]
    \111\ Barnsteiner JH. Medication reconciliation: transfer of 
medication information across settings-keeping it free from error. J 
Infus Nurs. 2005;28(2 Suppl):31-36.
    \112\ Rozich J, Roger, R. Medication safety: one organization's 
approach to the challenge. Journal of Clinical Outcomes Management. 
2001(8):27-34.
    \113\ Gleason KM, Groszek JM, Sullivan C, Rooney D, Barnard C, 
Noskin GA. Reconciliation of discrepancies in medication histories 
and admission orders of newly hospitalized patients. Am J Health 
Syst Pharm. 2004;61(16):1689-1695.
    \114\ Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, 
Budnitz DS. US emergency department visits for outpatient adverse 
drug events, 2013-2014. JAMA. doi: 10.1001/jama.2016.16201.
---------------------------------------------------------------------------

    Understanding the types of medication a patient is taking and the 
reason for its use are key facets of a patient's treatment with respect 
to medication. Some classes of drugs are associated with more risk than 
others.\115\ We are proposing one High-Risk Drug Class data element 
with six sub-elements. The six medication classes response options are: 
Anticoagulants; antiplatelets; hypoglycemics (including insulin); 
opioids; antipsychotics; and antibiotics. These drug classes are high-
risk due to the adverse effects that may result from use. In 
particular, bleeding risk is associated with anticoagulants and 
antiplatelets;116 117 fluid retention, heart failure, and 
lactic acidosis are associated with hypoglycemics;\118\ misuse is 
associated with opioids; \119\ fractures and strokes are associated 
with antipsychotics;120 121 and various adverse events such 
as central nervous systems effects and gastrointestinal intolerance are 
associated with antimicrobials,\122\ the larger category of medications 
that include antibiotics. Moreover, some medications in five of the six 
drug classes included as response options in this data element are 
included in the 2019 Updated Beers Criteria[supreg] list as potentially 
inappropriate medications for use in older adults.\123\ Finally, 
although a complete medication list should record several important 
attributes of each medication (for example, dosage, route, stop date), 
recording an indication for the drug is of crucial importance.\124\
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    \115\ Ibid.
    \116\ Shoeb M, Fang MC. Assessing bleeding risk in patients 
taking anticoagulants. J Thromb Thrombolysis. 2013;35(3):312-319. 
doi: 10.1007/s11239-013-0899-7.
    \117\ Melkonian M, Jarzebowski W, Pautas E. Bleeding risk of 
antiplatelet drugs compared with oral anticoagulants in older 
patients with atrial fibrillation: a systematic review and 
meta[hyphen]analysis. J Thromb Haemost. 2017;15:1500-1510. DOI: 
10.1111/jth.13697.
    \118\ Hamnvik OP, McMahon GT. Balancing Risk and Benefit with 
Oral Hypoglycemic Drugs. The Mount Sinai journal of medicine, New 
York. 2009; 76:234-243.
    \119\ Naples JG, Gellad WF, Hanlon JT. The Role of Opioid 
Analgesics in Geriatric Pain Management. Clin Geriatr Med. 
2016;32(4):725-735.
    \120\ Rigler SK, Shireman TI, Cook-Wiens GJ, Ellerbeck EF, 
Whittle JC, Mehr DR, Mahnken JD. Fracture risk in nursing home 
residents initiating antipsychotic medications. J Am Geriatr Soc. 
2013; 61(5):715-722. [PubMed: 23590366]
    \121\ Wang S, Linkletter C, Dore D et al. Age, antipsychotics, 
and the risk of ischemic stroke in the Veterans Health 
Administration. Stroke 2012;43:28-31. doi:10.1161/
STROKEAHA.111.617191.
    \122\ Faulkner CM, Cox HL, Williamson JC. Unique aspects of 
antimicrobial use in older adults. Clin Infect Dis. 2005;40(7):997-
1004.
    \123\ American Geriatrics Society 2019 Beers Criteria Update 
Expert Panel. American Geriatrics Society 2019 Updated Beers 
Criteria for Potentially Inappropriate Medication Use in Older 
Adults. J Am Geriatr Soc 2019; 00:1-21. DOI: 10.1111/jgs.15767.
    \124\ Li Y, Salmasian H, Harpaz R, Chase H, Friedman C. 
Determining the reasons for medication prescriptions in the EHR 
using knowledge and natural language processing. AMIA Annu Symp 
Proc. 2011;2011:768-76.
---------------------------------------------------------------------------

    The High-Risk Drug Classes: Use and Indication data element 
requires an assessor to record whether or not a patient is taking any 
medications within six drug classes. The six response options for this 
data element are high-risk drug classes with particular relevance to 
PAC patients and residents, as identified by our data element 
contractor. The six data response options are Anticoagulants, 
Antiplatelets, Hypoglycemics, Opioids, Antipsychotics, and Antibiotics. 
For each drug class, the assessor is asked to indicate if the patient 
is taking any medications within the class, and, for drug classes in 
which medications were being taken, whether indications for all drugs 
in the class are noted in the medical record. For example, for the 
response option Anticoagulants, if the assessor indicates that the 
patient is taking anticoagulant medication, the assessor would then 
indicate if an indication is recorded in the medication record for the 
anticoagulant(s).
    The High-Risk Drug Classes: Use and Indication data element that is 
being proposed as a SPADE was developed as part of a larger set of data 
elements to assess medication reconciliation, the process of obtaining 
a patient's multiple medication lists and reconciling any 
discrepancies. For more information on the High-Risk Drug Classes: Use 
and Indication data element, we refer readers to the document titled, 
``Proposed Specifications for HH QRP Quality Measures and SPADEs,'' 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We sought public input on the relevance of conducting assessments 
on medication reconciliation and specifically on the proposed High-Risk 
Drug Classes: Use and Indication data element. Our data element 
contractor presented data elements related to medication reconciliation 
to the TEP convened on April 6 and 7, 2016. The TEP supported a focus 
on high-risk drugs, because of higher potential for harm to patients 
and residents, and were in favor of a data element to capture whether 
or not indications for medications were recorded in the medical record. 
A summary of the April 6 and 7, 2016 TEP meeting titled ``SPADE 
Technical Expert Panel Summary (First Convening)'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. Medication reconciliation data 
elements were also discussed at a second TEP meeting on January 5 and 
6, 2017, convened by our data element contractor.
    At this meeting, the TEP agreed about the importance of evaluating 
the medication reconciliation process, but disagreed about how this 
could be accomplished through standardized assessment. The TEP also 
disagreed about the usability and appropriateness of using the Beers 
Criteria to identify high-risk medications,\125\ although they were 
supportive of the other six drug classes named in the draft version of 
the data element, which are the six drug classes being proposed as 
response options in the proposed High-Risk Drug Classes: Use and 
Indications SPADE. A summary of the January 5 and 6, 2017 TEP meeting 
titled ``SPADE Technical Expert Panel Summary (Second Convening)'' is 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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    \125\ American Geriatrics Society 2015 Beers Criteria Update 
Expert Panel. American Geriatrics Society. Updated Beers Criteria 
for Potentially Inappropriate Medication Use in Older Adults. J Am 
Geriatr Soc 2015; 63:2227-2246.
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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

[[Page 34672]]

Management System Blueprint website. In input received from April 26 to 
June 26, 2017, several commenters expressed support for the medication 
reconciliation data elements that were put on display, noting the 
importance of medication reconciliation in preventing medication errors 
and stating that the items seemed feasible and clinically useful. A few 
commenters were critical of the choice of ten drug classes posted 
during that comment period--the six drug classes in the proposed SPADE, 
along with antidepressants, diuretics, antianxiety, and hypnotics--
arguing that ADEs are not limited to high-risk drugs, and raised issues 
related to training assessors to correctly complete a valid assessment 
of medication reconciliation. A summary report for the April 26 to June 
26, 2017 public comment period titled ``SPADE May-June 2017 Public 
Comment Summary Report'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The High-Risk Drug Classes: Use and Indication data element was 
included in the National Beta Test of candidate data elements conducted 
by our data element contractor from November 2017 to August 2018. 
Results of this test found the High-Risk Drug Classes: Use and 
Indication data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
High-Risk Drug Classes: Use and Indication data element in the National 
Beta Test can be found in the document titled, ``Proposed 
Specifications for HH QRP Quality Measures and SPADEs,'' available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018. The TEP acknowledged the challenges of assessing 
medication safety, and were supportive of some of the data elements 
focused on medication reconciliation that were tested in the National 
Beta Test. The TEP was especially supportive of the focus on the six 
high-risk drug classes--which they identified from among other options 
during the second convening of the TEP, described previously--and of 
using these classes to assess whether the indication for a drug is 
recorded. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. These 
activities provided updates on the field-testing work and solicited 
feedback on data elements considered for standardization, including the 
High-Risk Drug Classes: Use and Indication data element. One 
stakeholder group was critical of the six drug classes included as 
response options in the High-Risk Drug Classes: Use and Indication data 
element, noting that potentially risky medications (for example, muscle 
relaxants) are not included in this list; that there may be important 
differences between drugs within classes (for example, more recent 
versus older style antidepressants); and that drug allergy information 
is not captured. Finally, on November 27, 2018, our data element 
contractor hosted a public meeting of stakeholders to present the 
results of the National Beta Test and solicit additional comments. 
General input on the testing and item development process and concerns 
about burden were received from stakeholders during this meeting and 
via email through February 1, 2019. Additionally, one commenter 
questioned whether the time to complete the High-Risk Drug Classes: Use 
and Indication data element would differ across settings. A summary of 
the public input received from the November 27, 2018 stakeholder 
meeting titled ``Input on SPADEs Received After November 27, 2018 
Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing high-risk drugs and for 
whether or not indications are noted for high-risk drugs, stakeholder 
input, and strong test results, we are proposing that the High-Risk 
Drug Classes: Use and Indication data element meets the definition of 
standardized patient assessment data with respect to special services, 
treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act and to adopt the High-Risk Drug Classes: Use and Indication data 
element as standardized patient assessment data for use in the HH QRP.
3. Medical Condition and Comorbidity Data
    Assessing medical conditions and comorbidities is critically 
important for care planning and safety for patients and residents 
receiving PAC services, and the standardized assessment of selected 
medical conditions and comorbidities across PAC providers is important 
for managing care transitions and understanding medical complexity.
    We discuss our proposals for data elements related to the medical 
condition of pain as standardized patient assessment data. Appropriate 
pain management begins with a standardized assessment, and thereafter 
establishing and implementing an overall plan of care that is person-
centered, multi-modal, and includes the treatment team and the patient. 
Assessing and documenting the effect of pain on sleep, participation in 
therapy, and other activities may provide information on undiagnosed 
conditions and comorbidities and the level of care required, and do so 
more objectively than subjective numerical scores. With that, we assess 
that taken separately and together, these proposed data elements are 
essential for care planning, consistency across transitions of care, 
and identifying medical complexities, including undiagnosed conditions. 
We also conclude that it is the standard of care to always consider the 
risks and benefits associated with a personalized care plan, including 
the risks of any pharmacological therapy, especially opioids.\126\ We 
also conclude that in addition to assessing and appropriately treating 
pain through the optimum mix of pharmacologic, non-pharmacologic, and 
alternative therapies, while being cognizant of current prescribing 
guidelines, clinicians in partnership with patients are best able to 
mitigate factors that contribute to the current opioid 
crisis.127 128 129
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    \126\ Department of Health and Human Services: Pain Management 
Best Practices Inter-Agency Task Force. Draft Report on Pain 
Management Best Practices: Updates, Gaps, Inconsistencies, and 
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \127\ Department of Health and Human Services: Pain Management 
Best Practices Inter-Agency Task Force. Draft Report on Pain 
Management Best Practices: Updates, Gaps, Inconsistencies, and 
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \128\ Fishman SM, Carr DB, Hogans B, et al. Scope and Nature of 
Pain- and Analgesia-Related Content of the United States Medical 
Licensing Examination (USMLE). Pain Med Malden Mass. 2018;19(3):449-
459. doi:10.1093/pm/pnx336.
    \129\ Fishman SM, Young HM, Lucas Arwood E, et al. Core 
competencies for pain management: results of an interprofessional 
consensus summit. Pain Med Malden Mass. 2013;14(7):971-981. 
doi:10.1111/pme.12107.

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[[Page 34673]]

    In alignment with our Meaningful Measures Initiative, accurate 
assessment of medical conditions and comorbidities of patients and 
residents in PAC is expected to make care safer by reducing harm caused 
in the delivery of care; promoting effective prevention and treatment 
of chronic disease; strengthening person and family engagement as 
partners in their care; and promoting effective communication and 
coordination of care. The proposed SPADEs will enable or support 
clinical decision-making and early clinical intervention; person-
centered, high quality care through: Facilitating better care 
continuity and coordination; better data exchange and interoperability 
between settings; and longitudinal outcome analysis. Therefore, 
reliable data elements assessing medical conditions and comorbidities 
are needed in order to initiate a management program that can optimize 
a patient's or resident's prognosis and reduce the possibility of 
adverse events.
    We are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to medical 
conditions and comorbidities.
a. Pain Interference (Pain Effect on Sleep, Pain Interference With 
Therapy Activities, and Pain Interference With Day-to-Day Activities)
    In acknowledgement of the opioid crisis, we specifically are 
seeking comment on whether or not we should add these pain items in 
light of those concerns. Commenters should address to what extent 
collection of the data through patient queries might encourage 
providers to prescribe opioids.
    We are proposing that a set of three data elements on the topic of 
Pain Interference (Pain Effect on Sleep, Pain Interference with Therapy 
Activities, and Pain Interference with Day-to-Day Activities) meet the 
definition of standardized patient assessment data with respect to 
medical conditions and comorbidities under section 1899B(b)(1)(B)(iv) 
of the Act.
    The practice of pain management began to undergo significant 
changes in the 1990s because the inadequate, non-standardized, non-
evidence-based assessment and treatment of pain became a public health 
issue.\130\ In pain management, a critical part of providing 
comprehensive care is performance of a thorough initial evaluation, 
including assessment of both the medical and any biopsychosocial 
factors causing or contributing to the pain, with a treatment plan to 
address the causes of pain and to manage pain that persists over 
time.\131\ Quality pain management, based on current guidelines and 
evidence-based practices, can minimize unnecessary opioid prescribing 
both by offering alternatives or supplemental treatment to opioids and 
by clearly stating when they may be appropriate, and how to utilize 
risk-benefit analysis for opioid and non-opioid treatment 
modalities.\132\
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    \130\ 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/.
    \131\ Department of Health and Human Services: Pain Management 
Best Practices Inter-Agency Task Force. Draft Report on Pain 
Management Best Practices: Updates, Gaps, Inconsistencies, and 
Recommendations. Accessed April 1, 2019. https://www.hhs.gov/sites/default/files/final-pmtf-draft-report-on-pain-management%20-best-practices-2018-12-12-html-ready-clean.pdf.
    \132\ National Academies. Pain Management and the Opioid 
Epidemic: Balancing Societal and Individual Benefits and Risks of 
Prescription Opioid Use. Washington DC: National Academies of 
Sciences, Engineering, and Medicine; 2017.
---------------------------------------------------------------------------

    Pain is not a surprising symptom in PAC patients and residents, 
where healing, recovery, and rehabilitation often require regaining 
mobility and other functions after an acute event. Standardized 
assessment of pain that interferes with function is an important first 
step toward appropriate pain management in PAC settings. The National 
Pain Strategy called for refined assessment items on the topic of pain, 
and describes the need for these improved measures to be implemented in 
PAC assessments.\133\ Further, the focus on pain interference, as 
opposed to pain intensity or pain frequency, was supported by the TEP 
convened by our data element contractor as an appropriate and 
actionable metric for assessing pain. A summary of the September 17, 
2018 TEP meeting titled ``SPADE Technical Expert Panel Summary (Third 
Convening)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \133\ National Pain Strategy: A Comprehensive Population-Health 
Level Strategy for Pain. https://iprcc.nih.gov/sites/default/files/HHSNational_Pain_Strategy_508C.pdf.
---------------------------------------------------------------------------

    We appreciate the important concerns related to the misuse and 
overuse of opioids in the treatment of pain and to that end we note 
that in this proposed rule we have also proposed a SPADE that assess 
for the use of, as well as importantly the indication for that use of, 
high risk drugs, including opioids. Further, in the CY 2017 HH PPS 
final rule (81 FR 76780) we adopted the Drug Regimen Review Conducted 
With Follow-Up for Identified Issues--Post Acute Care (PAC) HH QRP 
measure, which assesses whether PAC providers were responsive to 
potential or actual clinically significant medication issue(s) 
including issues associated with use and misuse of opioids for pain 
management, when such issues were identified.
    We also note that the proposed SPADEs related to pain assessment 
are not associated with any particular approach to management. Since 
the use of opioids is associated with serious complications, 
particularly in the elderly, an array of successful non-pharmacologic 
and non-opioid approaches to pain management may be considered.\134\ 
\135\ \136\ PAC providers have historically used a range of pain 
management strategies, including non-steroidal anti-inflammatory drugs, 
ice, transcutaneous electrical nerve stimulation (TENS) therapy, 
supportive devices, acupuncture, and the like. In addition, non-
pharmacological interventions implemented for pain management include, 
but are not limited to, biofeedback, application of heat/cold, massage, 
physical therapy, nerve block, stretching and strengthening exercises, 
chiropractic, electrical stimulation, radiotherapy, and 
ultrasound.\137\ \138\ \139\
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    \134\ Chau, D.L., Walker, V., Pai, L., & Cho, L.M. (2008). 
Opiates and elderly: use and side effects. Clinical interventions in 
aging, 3(2), 273-8.
    \135\ Fine, P.G. (2009). Chronic Pain Management in Older 
Adults: Special Considerations. Journal of Pain and Symptom 
Management, 38(2): S4-S14.
    \136\ Solomon, D.H., Rassen, J.A., Glynn, R.J., Garneau, K., 
Levin, R., Lee, J., & Schneeweiss, S. (2010). Archives Internal 
Medicine, 170(22):1979-1986.
    \137\ Byrd L. Managing chronic pain in older adults: a long-term 
care perspective. Annals of Long-Term Care: Clinical Care and Aging. 
2013;21(12):34-40.
    \138\ Kligler, B., Bair, M.J., Banerjea, R. et al. (2018). 
Clinical Policy Recommendations from the VHA State-of-the-Art 
Conference on Non-Pharmacological Approaches to Chronic 
Musculoskeletal Pain. Journal of General Internal Medicine, 33(Suppl 
1): 16. https://doi.org/10.1007/s11606-018-4323-z.
    \139\ Chou, R., Deyo, R., Friedly, J., et al. (2017). 
Nonpharmacologic Therapies for Low Back Pain: A Systematic Review 
for an American College of Physicians Clinical Practice Guideline. 
Annals of Internal Medicine, 166(7):493-505.
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    We believe that standardized assessment of pain interference will 
support PAC clinicians in applying best-practices in pain management 
for chronic and acute pain, consistent with current clinical 
guidelines. For example,

[[Page 34674]]

the standardized assessment of both opioids and pain interference would 
support providers in successfully tapering patients/residents who 
arrive in the PAC setting with long-term use of opioids onto non-
pharmacologic treatments and non-opioid medications, as recommended by 
the Society for Post-Acute and Long-Term Care Medicine,\140\ and 
consistent with HHS's 5-Point Strategy To Combat the Opioid Crisis 
\141\ which includes ``Better Pain Management.''
---------------------------------------------------------------------------

    \140\ Society for Post-Acute and Long-Term Care Medicine (AMDA). 
(2018). Opioids in Nursing Homes: Position Statement. https://paltc.org/opioids%20in%20nursing%20homes.
    \141\ https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/.
---------------------------------------------------------------------------

    The Pain Interference data element set consists of three data 
elements: Pain Effect on Sleep, Pain Interference with Therapy 
Activities, and Pain Interference with Day-to-Day Activities. Pain 
Effect on Sleep assesses the frequency with which pain affects a 
patient's sleep. Pain Interference with Therapy Activities assesses the 
frequency with which pain interferes with a patient's ability to 
participate in therapies. The Pain Interference with Day-to-Day 
Activities assesses the extent to which pain interferes with a 
patient's ability to participate in day-to-day activities excluding 
therapy.
    A similar data element on the effect of pain on activities is 
currently included in the OASIS. A similar data element on the effect 
on sleep is currently included in the MDS instrument in SNFs. We are 
proposing to add the Pain Interference data element set (Pain Effect on 
Sleep, Pain Interference with Therapy Activities, and Pain Interference 
with Day-to-Day Activities) to the OASIS and to remove M1242, Frequency 
of Pain Interfering with Patient's Activity or Movement. For more 
information on the Pain Interference data elements, we refer readers to 
the document titled, ``Proposed Specifications for HH QRP Quality 
Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We sought public input on the relevance of conducting assessments 
on pain and specifically on the larger set of Pain Interview data 
elements included in the National Beta Test. The proposed data elements 
were supported by comments from the TEP meeting held by our data 
element contractor on April 7 to 8, 2016. The TEP affirmed the 
feasibility and clinical utility of pain as a concept in a standardized 
assessment. The TEP agreed that data elements on pain interference with 
ability to participate in therapies versus other activities should be 
addressed. Further, during a more recent convening of the same TEP on 
September 17, 2018, the TEP supported the interview-based pain data 
elements included in the National Beta Test. The TEP members were 
particularly supportive of the items that focused on how pain 
interferes with activities (that is, Pain Interference data elements) 
because understanding the extent to which pain interferes with function 
would enable clinicians to determine the need for appropriate pain 
treatment. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We held a public comment period in 2016 to solicit feedback on the 
standardization of pain and several other items that were under 
development in prior efforts, through a call for input published on the 
CMS Measures Management System Blueprint website. From the prior public 
comment period, we included several pain data elements (Pain Effect on 
Sleep; Pain Interference--Therapy Activities; Pain Interference--Other 
Activities) in a second call for public comment, also published on the 
CMS Measures Management System Blueprint website, open from April 26 to 
June 26, 2017. The items we sought comment on were modified from all 
stakeholder and test efforts. Commenters provided general comments 
about pain assessment in general in addition to feedback on the 
specific pain items. A few commenters shared their support for 
assessing pain, the potential for pain assessment to improve the 
quality of care, and for the validity and reliability of the data 
elements. Commenters affirmed that the item of pain and the effect on 
sleep would be suitable for PAC settings. Commenters' main concerns 
included redundancy with existing data elements, feasibility and 
utility for cross-setting use, and the applicability of interview-based 
items to patients and residents with cognitive or communication 
impairments, and deficits. A summary report for the April 26 to June 
26, 2017 public comment period titled ``SPADE May-June 2017 Public 
Comment Summary Report'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Pain Interference data elements were included in the National 
Beta Test of candidate data elements conducted by our data element 
contractor from November 2017 to August 2018. Results of this test 
found the Pain Interference data elements to be feasible and reliable 
for use with PAC patients and residents. More information about the 
performance of the Pain Interference data elements in the National Beta 
Test can be found in the document titled, ``Proposed Specifications for 
HH QRP Quality Measures and SPADEs,'' available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on 
September 17, 2018 for the purpose of soliciting input on the proposed 
standardized patient assessment data elements. The TEP supported the 
interview-based pain data elements included in the National Beta Test. 
The TEP members were particularly supportive of the items that focused 
on how pain interferes with activities (that is, Pain Interference data 
elements), because understanding the extent to which pain interferes 
with function would enable clinicians to determine the need for pain 
treatment. A summary of the September 17, 2018 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Third Convening)'' is available 
at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Additionally, one commenter expressed strong support for the 
proposed pain SPADEs and was encouraged by the fact

[[Page 34675]]

that this portion of the assessment surpasses pain presence. A summary 
of the public input received from the November 27, 2018 stakeholder 
meeting titled ``Input on SPADEs Received After November 27, 2018 
Stakeholder Meeting'' is available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Taking together the importance of assessing the effect of pain on 
function, stakeholder input, and strong test results, we are proposing 
that the set of Pain Interference data elements (Pain Effect on Sleep, 
Pain Interference with Therapy Activities, and Pain Interference with 
Day-to-Day Activities) meet the definition of standardized patient 
assessment data with respect to medical conditions and comorbidities 
under section 1899B(b)(1)(B)(iv) of the Act and to adopt the Pain 
Interference data elements (Pain Effect on Sleep, Pain Interference 
with Therapy Activities, and Pain Interference with Day-to-Day 
Activities) as standardized patient assessment data for use in the HH 
QRP.
4. Impairment Data
    Hearing and vision impairments are conditions that, if unaddressed, 
affect activities of daily living, communication, physical functioning, 
rehabilitation outcomes, and overall quality of life. Sensory 
limitations can lead to confusion in new settings, increase isolation, 
contribute to mood disorders, and impede accurate assessment of other 
medical conditions. Failure to appropriately assess, accommodate, and 
treat these conditions increases the likelihood that patients and 
residents will require more intensive and prolonged treatment. Onset of 
these conditions can be gradual, so individualized assessment with 
accurate screening tools and follow-up evaluations are essential to 
determining which patients and residents need hearing- or vision-
specific medical attention or assistive devices and accommodations, 
including auxiliary aids and/or services, and to ensure that person-
directed care plans are developed to accommodate a patient's or 
resident's needs. Accurate diagnosis and management of hearing or 
vision impairment would likely improve rehabilitation outcomes and care 
transitions, including transition from institutional-based care to the 
community. Accurate assessment of hearing and vision impairment would 
be expected to lead to appropriate treatment, accommodations, including 
the provision of auxiliary aids and services during the stay, and 
ensure that patients and residents continue to have their vision and 
hearing needs met when they leave the facility. In addition, entities 
that receive Federal financial assistance, such as through Medicare 
Parts A, C, and D, must take appropriate steps to ensure effective 
communication for individuals with disabilities, including provision of 
appropriate auxiliary aids and services.\142\
---------------------------------------------------------------------------

    \142\ Section 504 of the Rehabilitation Act of 1973, section1557 
of the Affordable Care Act, and their respective implementing 
regulations. More information is available at: https://www.hhs.gov/civil-rights/for-individuals/disability/, 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 are inviting comment on our proposals to collect as standardized 
patient assessment data the following data with respect to impairments.
a. Hearing
    We are proposing that the Hearing data element meets the definition 
of standardized patient assessment data with respect to impairments 
under section 1899B(b)(1)(B)(v) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35369 
through 35370), accurate assessment of hearing impairment is important 
in the PAC setting for care planning and resource use. Hearing 
impairment has been associated with lower quality of life, including 
poorer physical, mental, and social functioning, and emotional 
health.143 144 Treatment and accommodation of hearing 
impairment led to improved health outcomes, including but not limited 
to quality of life.\145\ For example, hearing loss in elderly 
individuals has been associated with depression and cognitive 
impairment,146 147 148 higher rates of incident cognitive 
impairment and cognitive decline,\149\ and less time in occupational 
therapy.\150\ Accurate assessment of hearing impairment is important in 
the PAC setting for care planning and defining resource use.
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    \143\ Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, 
Nondahl DM. The impact of hearing loss on quality of life in older 
adults. Gerontologist. 2003;43(5):661-668.
    \144\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The 
prevalence of hearing impairment and its burden on the quality of 
life among adults with Medicare Supplement Insurance. Qual Life Res. 
2012; 21(7):1135-1147.
    \145\ Horn KL, McMahon NB, McMahon DC, Lewis JS, Barker M, 
Gherini S. Functional use of the Nucleus 22-channel cochlear implant 
in the elderly. The Laryngoscope. 1991; 101(3):284-288.
    \146\ Sprinzl GM, Riechelmann H. Current trends in treating 
hearing loss in elderly people: a review of the technology and 
treatment options--a mini-review. Gerontology. 2010; 56(3):351-358.
    \147\ Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing 
Loss Prevalence and Risk Factors Among Older Adults in the United 
States. The Journals of Gerontology Series A: Biological Sciences 
and Medical Sciences. 2011; 66A(5):582-590.
    \148\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The 
prevalence of hearing impairment and its burden on the quality of 
life among adults with Medicare Supplement Insurance. Qual Life Res. 
2012; 21(7):1135-1147.
    \149\ Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB, 
Ferrucci L. Hearing Loss and Incident Dementia. Arch Neurol. 2011; 
68(2):214-220.
    \150\ Cimarolli VR, Jung S. Intensity of Occupational Therapy 
Utilization in Nursing Home Residents: The Role of Sensory 
Impairments. J Am Med Dir Assoc. 2016;17(10):939-942.
---------------------------------------------------------------------------

    The proposed data element consists of the single Hearing data 
element. This data consists of one question that assesses level of 
hearing impairment. This data element is currently in use in the MDS in 
SNFs. For more information on the Hearing data element, we refer 
readers to the document titled, ``Proposed Specifications for HH QRP

[[Page 34676]]

Quality Measures and SPADEs'', available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Hearing data element was first proposed as a standardized 
patient assessment data element in the CY 2018 HH PPS proposed rule (82 
FR 35369 through 35370). In that proposed rule, we stated that the 
proposal was informed by input we received through a call for input 
published on the CMS Measures Management System Blueprint website. 
Input submitted on the PAC PRD form of the data element (``Ability to 
Hear'') from August 12 to September 12, 2016, recommended that hearing, 
vision, and communication assessments be administered at the beginning 
of patient assessment process. A summary report for the August 12 to 
September 12, 2016 public comment period titled ``SPADE August 2016 
Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter noted that resources would be needed for a change in the 
OASIS to account for the Hearing data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Hearing data element was included in the National Beta Test 
of candidate data elements conducted by our data element contractor 
from November 2017 to August 2018. Results of this test found the 
Hearing data element to be feasible and reliable for use with PAC 
patients and residents. More information about the performance of the 
Hearing data element in the National Beta Test can be found in the 
document titled, ''Proposed Specifications for HH QRP Quality Measures 
and SPADEs, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on January 
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs, 
including the Hearing data element. The TEP affirmed the importance of 
standardized assessment of hearing impairment in PAC patients and 
residents. A summary of the January 5 and 6, 2017 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Second Convening)'' is 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Additionally, a commenter expressed support for the Hearing data 
element and suggested administration at the beginning of the patient 
assessment to maximize utility. A summary of the public input received 
from the November 27, 2018 stakeholder meeting titled ``Input on SPADEs 
Received After November 27, 2018 Stakeholder Meeting'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Due to the relatively stable nature of hearing impairment, we are 
proposing that HHAs that submit the Hearing data element with respect 
to SOC will be deemed to have submitted with respect to discharge. 
Taking together the importance of assessing hearing, stakeholder input, 
and strong test results, we are proposing that the Hearing data element 
meets the definition of standardized patient assessment data with 
respect to impairments under section 1899B(b)(1)(B)(v) of the Act and 
to adopt the Hearing data element as standardized patient assessment 
data for use in the HH QRP.
b. Vision
    We are proposing that the Vision data element meets the definition 
of standardized patient assessment data with respect to impairments 
under section 1899B(b)(1)(B)(v) of the Act.
    As described in the CY 2018 HH PPS proposed rule (82 FR 35370 
through 35371), evaluation of an individual's ability to see is 
important for assessing risks such as falls and provides opportunities 
for improvement through treatment and the provision of accommodations, 
including auxiliary aids and services, which can safeguard patients and 
residents and improve their overall quality of life. Further, vision 
impairment is often a treatable risk factor associated with adverse 
events and poor quality of life. For example, individuals with visual 
impairment are more likely to experience falls and hip fracture, have 
less mobility, and report depressive 
symptoms.151 152 153 154 155 156 157 Individualized initial 
screening can lead to life-improving interventions such as 
accommodations, including the provision of auxiliary aids and services, 
during the stay and/or treatments that can improve vision and prevent 
or slow further vision loss. In addition, vision impairment is often a 
treatable risk factor associated with adverse events which can be 
prevented and accommodated during the stay. Accurate assessment of 
vision impairment is important in the HH setting for care planning and 
defining resource use.
---------------------------------------------------------------------------

    \151\ Colon-Emeric CS, Biggs DP, Schenck AP, Lyles KW. Risk 
factors for hip fracture in skilled nursing facilities: who should 
be evaluated? Osteoporos Int. 2003;14(6):484-489.
    \152\ Freeman EE, Munoz B, Rubin G, West SK. Visual field loss 
increases the risk of falls in older adults: the Salisbury eye 
evaluation. Invest Ophthalmol Vis Sci. 2007;48(10):4445-4450.
    \153\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-
level clinical outcomes of home health care. J Nurs Scholarsh. 
2004;36(1):79-85.
    \154\ Nguyen HT, Black SA, Ray LA, Espino DV, Markides KS. 
Predictors of decline in MMSE scores among older Mexican Americans. 
J Gerontol A Biol Sci Med Sci. 2002;57(3):M181-185.
    \155\ Prager AJ, Liebmann JM, Cioffi GA, Blumberg DM. Self-
reported Function, Health Resource Use, and Total Health Care Costs 
Among Medicare Beneficiaries With Glaucoma. JAMA ophthalmology. 
2016;134(4):357-365.
    \156\ Rovner BW, Ganguli M. Depression and disability associated 
with impaired vision: the MoVies Project. J Am Geriatr Soc. 
1998;46(5):617-619.
    \157\ Tinetti ME, Ginter SF. The nursing home life-space 
diameter. A measure of extent and frequency of mobility among 
nursing home residents. J Am Geriatr Soc. 1990;38(12):1311-1315.
---------------------------------------------------------------------------

    The proposed data element consists of the single Vision (Ability to 
See in Adequate Light) data element that consists of one question with 
five response categories. The Vision data element that we are proposing 
for standardization was tested as part of the development of the MDS 
for SNFs and is currently in use in that assessment. A similar data 
element, but with different wording and fewer response option 
categories, is in use in the OASIS. We are proposing to add the Vision 
(Ability to See in Adequate Light) data element to the OASIS to replace 
M1200, Vision. For more information on the Vision data element, we 
refer readers to the document titled, ``Proposed

[[Page 34677]]

Specifications for HH QRP Quality Measures and SPADEs,'' available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The Vision data element was first proposed as a standardized 
patient assessment data element in the CY 2018 HH PPS proposed rule (82 
FR 35370 through 35371). In that proposed rule, we stated that the 
proposal was informed by input we received from August 12 to September 
12, 2016, on the Ability to See in Adequate Light data element (version 
tested in the PAC PRD with three response categories) through a call 
for input published on the CMS Measures Management System Blueprint 
website. The data element on which we solicited input differed from the 
proposed data element, but input submitted from August 12 to September 
12, 2016 supported the assessment of vision in PAC settings and the 
useful information a vision data element would provide. We also stated 
that commenters had noted that the Ability to See item would provide 
important information that would facilitate care coordination and care 
planning, and consequently improve the quality of care. Other 
commenters suggested it would be helpful as an indicator of resource 
use and noted that the item would provide useful information about the 
abilities of patients and residents to care for themselves. Additional 
commenters noted that the item could feasibly be implemented across PAC 
providers and that its kappa scores from the PAC PRD support its 
validity. Some commenters noted a preference for MDS version of the 
Vision data element over the form put forward in public comment, citing 
the widespread use of this data element. A summary report for the 
August 12 to September 12, 2016 public comment period titled ``SPADE 
August 2016 Public Comment Summary Report'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In response to our proposal in the CY 2018 HH PPS proposed rule, 
one commenter noted that resources would be needed for a change in the 
OASIS to account for the Vision data element.
    Subsequent to receiving comments on the CY 2018 HH PPS proposed 
rule, the Vision data element was included in the National Beta Test of 
candidate data elements conducted by our data element contractor from 
November 2017 to August 2018. Results of this test found the Vision 
data element to be feasible and reliable for use with PAC patients and 
residents. More information about the performance of the Vision data 
element in the National Beta Test can be found in the document titled, 
``Proposed Specifications for HH QRP Quality Measures and SPADEs,'' 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In addition, our data element contractor convened a TEP on January 
5 and 6, 2017 for the purpose of soliciting input on all the SPADEs 
including the Vision data element. The TEP affirmed the importance of 
standardized assessment of vision impairment in PAC patients and 
residents. A summary of the January 5 and 6, 2017 TEP meeting titled 
``SPADE Technical Expert Panel Summary (Second Convening)'' is 
available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We also held Special Open Door Forums and small-group discussions 
with PAC providers and other stakeholders in 2018 for the purpose of 
updating the public about our ongoing SPADE development efforts. 
Finally, on November 27, 2018, our data element contractor hosted a 
public meeting of stakeholders to present the results of the National 
Beta Test and solicit additional comments. General input on the testing 
and item development process and concerns about burden were received 
from stakeholders during this meeting and via email through February 1, 
2019. Additionally, a commenter expressed support for the Vision data 
element and suggested administration at the beginning of the patient 
assessment to maximize utility. A summary of the public input received 
from the November 27, 2018 stakeholder meeting titled ``Input on SPADEs 
Received After November 27, 2018 Stakeholder Meeting'' is available at: 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Due to the relatively stable nature of vision impairment, we are 
proposing that HHAs that submit the Vision data element with respect to 
SOC will be deemed to have submitted with respect to discharge. Taking 
together the importance of assessing vision, stakeholder input, and 
strong test results, we are proposing that the Vision data element 
meets the definition of standardized patient assessment data with 
respect to impairments under section 1899B(b)(1)(B)(v) of the Act and 
to adopt the Vision data element as standardized patient assessment 
data for use in the HH QRP.
5. Proposed New Category: Social Determinants of Health
a. Proposed Social Determinants of Health Data Collection To Inform 
Measures and Other Purposes
    Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS 
to assess appropriate adjustments to quality measures, resource 
measures, and other measures, and to assess and implement appropriate 
adjustments to payment under Medicare based on those measures, after 
taking into account studies conducted by ASPE on social risk factors 
(described elsewhere in this proposed rule) and other information, and 
based on an individual's health status and other factors. Subparagraph 
(C) of section 2(d)(2) of the IMPACT Act further requires the Secretary 
to carry out periodic analyses, at least every three years, based on 
the factors referred to subparagraph (A) so as to monitor changes in 
possible relationships. Subparagraph (B) of section 2(d)(2) of the 
IMPACT Act requires CMS to collect or otherwise obtain access to data 
necessary to carry out the requirement of the paragraph (both assessing 
adjustments described previously in such subparagraph (A) and for 
periodic analyses in such subparagraph (C)). Accordingly we are 
proposing to use our authority under subparagraph (B) of section 
2(d)(2) of the IMPACT Act to establish a new data source for 
information to meet the requirements of subparagraphs (A) and (C) of 
section 2(d)(2). In this rule, we are proposing to collect and access 
data about social determinants of health (SDOH) in order to perform 
CMS' responsibilities under subparagraphs (A) and (C) of section 
2(d)(2) of the IMPACT Act, as explained in more detail elsewhere in 
this proposed rule. Social determinants of health, also known as social 
risk factors, or health-related social needs, are the socioeconomic, 
cultural and environmental circumstances in which individuals live that 
impact their health. We are proposing to collect information on seven 
proposed SDOH SPADE data elements relating to race, ethnicity, 
preferred language, interpreter services, health literacy, 
transportation, and

[[Page 34678]]

social isolation; a detailed discussion of each of the proposed SDOH 
data elements is found in section IV.A.7.f.(ii). of this proposed rule.
    We are also proposing to use the OASIS, the current version being 
OASIS-D, described as the PAC assessment instrument for home health 
agencies under section 1899B(a)(2)(B)(i) of the Act, to collect these 
data via an existing data collection mechanism. We believe this 
approach will provide CMS with access to data with respect to the 
requirements of section 2(d)(2) of the IMPACT Act, while minimizing the 
reporting burden on PAC health care providers by relying on a data 
reporting mechanism already used and an existing system to which PAC 
providers are already accustomed.
    The IMPACT Act includes several requirements applicable to the 
Secretary, in addition to those imposing new data reporting obligations 
on certain PAC providers as discussed in section IV.A.7.f.(2). of this 
proposed rule. Subparagraphs (A) and (B) of section 2(d)(1) of the 
IMPACT Act require the Secretary, acting through the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE), to conduct two 
studies that examine the effect of risk factors, including individuals' 
socioeconomic status, on quality, resource use and other measures under 
the Medicare program. The first ASPE study was completed in December 
2016 and is discussed in this proposed rule, and the second study is to 
be completed in the fall of 2019. We recognize that ASPE, in its 
studies, is considering a broader range of social risk factors than the 
SDOH data elements in this proposal, and address both PAC and non-PAC 
settings. We acknowledge that other data elements may be useful to 
understand, and that some of those elements may be of particular 
interest in non-PAC settings. For example, for beneficiaries receiving 
care in the community, as opposed to an in-patient facility, housing 
stability and food insecurity may be more relevant. We will continue to 
take into account the findings from both of ASPE's reports in future 
policy making.
    One of the ASPE's first actions under the IMPACT Act was to 
commission the National Academies of Sciences, Engineering and Medicine 
(NASEM) to define and conceptualize socioeconomic status for the 
purposes of ASPE's two studies under section 2(d)(1) of the IMPACT Act. 
The NASEM convened a panel of experts in the field and conducted an 
extensive literature review. Based on the information collected, the 
2016 NASEM panel report titled, ``Accounting for Social Risk Factors in 
Medicare Payment: Identifying Social Risk Factors,'' concluded that the 
best way to assess how social processes and social relationships 
influence key health-related outcomes in Medicare beneficiaries is 
through a framework of social risk factors instead of socioeconomic 
status. Social risk factors discussed in the NASEM report include 
socioeconomic position, race, ethnicity, gender, social context, and 
community context. These factors are discussed at length in chapter 2 
of the NASEM report, entitled ``Social Risk Factors.'' \158\ 
Consequently NASEM framed the results of its report in terms of 
``social risk factors'' rather than ``socioeconomic status'' or 
``sociodemographic status.'' The full text of the ``Social Risk 
Factors'' NASEM report is available for reading on the website at 
https://www.nap.edu/read/21858/chapter/1.
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    \158\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for social risk factors in Medicare payment: 
Identifying social risk factors. Chapter 2. Washington, DC: The 
National Academies Press.
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    Each of the data elements we are proposing to collect and access 
pursuant to our authority under section 2(d)(2)(B) of the IMPACT Act is 
identified in the 2016 NASEM report as a social risk factor that has 
been shown to impact care use, cost and outcomes for Medicare 
beneficiaries. CMS uses the term social determinants of health (SDOH) 
to denote social risk factors, which is consistent with the objectives 
of Healthy People 2020.\159\
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    \159\ Social Determinants of Health. Healthy People 2020. 
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
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    ASPE issued its first Report to Congress, entitled ``Social Risk 
Factors and Performance Under Medicare's Value-Based Purchasing 
Programs,'' under section 2(d)(1)(A) of the IMPACT Act on December 21, 
2016.\160\ Using NASEM's social risk factors framework, ASPE focused on 
the following social risk factors, in addition to disability: (1) Dual 
enrollment in Medicare and Medicaid as a marker for low income; (2) 
residence in a low-income area; (3) Black race; (4) Hispanic ethnicity; 
and (5) residence in a rural area. ASPE acknowledged that the social 
risk factors examined in its report were limited due to data 
availability. The report also noted that the data necessary to 
meaningfully attempt to reduce disparities and identify and reward 
improved outcomes for beneficiaries with social risk factors have not 
been collected consistently on a national level in post-acute care 
settings. Where these data have been collected, the collection 
frequently involves lengthy questionnaires. More information on the 
Report to Congress on Social Risk Factors and Performance under 
Medicare's Value-Based Purchasing Programs, including the full report, 
is available on the website at https://aspe.hhs.gov/social-risk-factors-and-medicares-value-based-purchasing-programs-reports.
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    \160\ U.S. Department of Health and Human Services, Office of 
the Assistant Secretary for Planning and Evaluation. 2016. Report to 
Congress: Social Risk Factors and Performance Under Medicare's 
Value-Based Payment Programs. Washington, DC.
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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

[[Page 34679]]

suggested a three-pronged strategy to guide the development of value-
based payment programs under which all Medicare beneficiaries receive 
the highest quality healthcare services possible. The three components 
of this strategy are to: (1) Measure and report quality of care for 
beneficiaries with social risk factors; (2) set high, fair quality 
standards for care provided to all beneficiaries; and (3) reward and 
support better outcomes for beneficiaries with social risk factors. In 
discussing how measuring and reporting quality for beneficiaries with 
social risk factors can be applied to Medicare quality payment 
programs, the report offered nine considerations across the three-
pronged strategy, including enhancing data collection and developing 
statistical techniques to allow measurement and reporting of 
performance for beneficiaries with social risk factors on key quality 
and resource use measures.
    Congress, in section 2(d)(2)(B) of the IMPACT Act, required the 
Secretary to collect or otherwise obtain access to the data necessary 
to carry out the provisions of paragraph (2) of section 2(d)(2) of the 
IMPACT Act through both new and existing data sources. Taking into 
consideration NASEM's conceptual framework for social risk factors 
discussed previously, ASPE's study, and considerations under section 
2(d)(1)(A) of the IMPACT Act, as well as the current data constraints 
of ASPE's first study and its suggested considerations, we are 
proposing to collect and access data about SDOH under section 2(d)(2) 
of the IMPACT Act. Our collection and use of the SDOH data described in 
section IV.A.7.f.(i). of this proposed rule, under section 2(d)(2) of 
the IMPACT Act, would be independent of our proposal (in section 
IV.A.7.f.(2). of this proposed rule) and our authority to require 
submission of that data for use as SPADE under section 1899B(a)(1)(B) 
of the Act.
    Accessing standardized data relating to the SDOH data elements on a 
national level is necessary to permit CMS to conduct periodic analyses, 
to assess appropriate adjustments to quality measures, resource use 
measures, and other measures, and to assess and implement appropriate 
adjustments to Medicare payments based on those measures. We agree with 
ASPE's observations, in the value-based purchasing context, that the 
ability to measure and track quality, outcomes, and costs for 
beneficiaries with social risk factors over time is critical as 
policymakers and providers seek to reduce disparities and improve care 
for these groups. Collecting the data as proposed will provide the 
basis for our periodic analyses of the relationship between an 
individual's health status and other factors and quality, resource, and 
other measures, as required by section 2(d)(2) of the IMPACT Act, and 
to assess appropriate adjustments. These data would also permit us to 
develop the statistical tools necessary to maximize the value of 
Medicare data, reduce costs and improve the quality of care for all 
beneficiaries. Collecting and accessing SDOH data in this way also 
supports the three-part strategy put forth in the first ASPE report, 
specifically ASPE's consideration to enhance data collection and 
develop statistical techniques to allow measurement and reporting of 
performance for beneficiaries with social risk factors on key quality 
and resource use measures.
    For the reasons discussed previously, we are proposing under 
section 2(d)(2) of the IMPACT Act, to collect the data on the following 
SDOH: (1) Race, as described in section V.G.5.b.(1). of this proposed 
rule; (2) Ethnicity, described in section V.G.5.b.(1). of this proposed 
rule; (3) Preferred Language, as described in section V.G.5.(ii).(2). 
of this proposed rule; (4) Interpreter Services, as described in 
section V.G.5.b.(2). of this proposed rule; (5) Health Literacy, as 
described in section V.G.5.b.(3). of this proposed rule; (6) 
Transportation, as described in section V.G.5.(ii).(4). of this 
proposed rule; and (7) Social Isolation, as described in section 
V.G.5.b.(5). of this proposed rule. These data elements are discussed 
in more detail in section V.G.5. of this proposed rule.
b. Standardized Patient Assessment Data
    Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to 
collect SPADEs with respect to other categories deemed necessary and 
appropriate. We are proposing to create a Social Determinants of Health 
SPADE category under section 1899B(b)(1)(B)(vi) of the Act. In addition 
to collecting SDOH data for the purposes outlined previously, under 
section 2(d)(2)(B), we are also proposing to collect as SPADE these 
same data elements (race, ethnicity, preferred language, interpreter 
services, health literacy, transportation, and social isolation) under 
section 1899B(b)(1)(B)(vi) of the Act. We believe that this proposed 
new category of Social Determinants of Health will inform provider 
understanding of individual patient risk factors and treatment 
preferences, facilitate coordinated care and care planning, and improve 
patient outcomes. We are proposing to deem this category necessary and 
appropriate, for the purposes of SPADE, because using common standards 
and definitions for PAC data elements is important in ensuring 
interoperable exchange of longitudinal information between PAC 
providers and other providers to facilitate coordinated care, 
continuity in care planning, and the discharge planning process from 
post-acute care settings.
    All of the Social Determinants of Health data elements we are 
proposing under section 1899B(b)(1)(B)(vi) of the Act have the capacity 
to take into account treatment preferences and care goals of patients 
and to inform our understanding of patient complexity and risk factors 
that may affect care outcomes. While acknowledging the existence and 
importance of additional SDOH, we are proposing to assess some of the 
factors relevant for patients receiving post-acute care that PAC 
settings are in a position to impact through the provision of services 
and supports, such as connecting patients with identified needs with 
transportation programs, certified interpreters, or social support 
programs.
    As previously mentioned, and described in more detail elsewhere in 
this proposed rule, we are proposing to adopt the following seven data 
elements as SPADE under the proposed Social Determinants of Health 
category: Race, ethnicity, preferred language, interpreter services, 
health literacy, transportation, and social isolation. To select these 
data elements, we reviewed the research literature, a number of 
validated assessment tools and frameworks for addressing SDOH currently 
in use (for example, Health Leads, NASEM, Protocol for Responding to 
and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), and 
ICD-10), and we engaged in discussions with stakeholders. We also 
prioritized balancing the reporting burden for PAC providers with our 
policy objective to collect SPADEs that will inform care planning and 
coordination and quality improvement across care settings. Furthermore, 
incorporating SDOH data elements into care planning has the potential 
to reduce readmissions and help beneficiaries achieve and maintain 
their health goals.
    We also considered feedback received during a listening session 
that we held on December 13, 2018. The purpose of the listening session 
was to solicit feedback from health systems, research organizations, 
advocacy organizations, state agencies, and other members of the public 
on collecting patient-level data on SDOH across care settings, 
including consideration of race, ethnicity, spoken

[[Page 34680]]

language, health literacy, social isolation, transportation, sex, 
gender identity, and sexual orientation. We also gave participants an 
option to submit written comments. A full summary of the listening 
session, titled ``Listening Session on Social Determinants of Health 
Data Elements: Summary of Findings,'' includes a list of participating 
stakeholders and their affiliations, and is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(1) Race and Ethnicity
    The persistence of racial and ethnic disparities in health and 
health care is widely documented, including in PAC 
settings.161 162 163 164 165 Despite the trend toward 
overall improvements in quality of care and health outcomes, the Agency 
for Healthcare Research and Quality, in its National Healthcare Quality 
and Disparities Reports, consistently indicates that racial and ethnic 
disparities persist, even after controlling for factors such as income, 
geography, and insurance.\166\ For example, racial and ethnic 
minorities tend to have higher rates of infant mortality, diabetes and 
other chronic conditions, and visits to the emergency department, and 
lower rates of having a usual source of care and receiving 
immunizations such as the flu vaccine.\167\ Studies have also shown 
that African Americans are significantly more likely than white 
Americans to die prematurely from heart disease and stroke.\168\ 
However, our ability to identify and address racial and ethnic health 
disparities has historically been constrained by data limitations, 
particularly for smaller populations groups such as Asians, American 
Indians and Alaska Natives, and Native Hawaiians and other Pacific 
Islanders.\169\
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    \161\ 2017 National Healthcare Quality and Disparities Report. 
Rockville, MD: Agency for Healthcare Research and Quality; September 
2018. AHRQ Pub. No. 18-0033-EF.
    \162\ Fiscella, K. and Sanders, M.R. Racial and Ethnic 
Disparities in the Quality of Health Care. (2016). Annual Review of 
Public Health. 37:375-394.
    \163\ 2018 National Impact Assessment of the Centers for 
Medicare & Medicaid Services (CMS) Quality Measures Reports. 
Baltimore, MD: U.S. Department of Health and Human Services, Centers 
for Medicare and Medicaid Services; February 28, 2018.
    \164\ Smedley, B.D., Stith, A.Y., & Nelson, A.R. (2003). Unequal 
treatment: confronting racial and ethnic disparities in health care. 
Washington, DC, National Academy Press.
    \165\ Chase, J., Huang, L. and Russell, D. (2017). Racial/ethnic 
disparities in disability outcomes among post-acute home care 
patients. J of Aging and Health. 30(9):1406-1426.
    \166\ National Healthcare Quality and Disparities Reports. 
(December 2018). Agency for Healthcare Research and Quality, 
Rockville, MD. https://www.ahrq.gov/research/findings/nhqrdr/.
    \167\ National Center for Health Statistics. Health, United 
States, 2017: With special feature on mortality. Hyattsville, 
Maryland. 2018.
    \168\ HHS. Heart disease and African Americans. 2016b. (October 
24, 2016). https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
    \169\ National Academies of Sciences, Engineering, and Medicine; 
Health and Medicine Division; Board on Population Health and Public 
Health Practice; Committee on Community-Based Solutions to Promote 
Health Equity in the United States; Baciu A, Negussie Y, Geller A, 
et al., editors. Communities in Action: Pathways to Health Equity. 
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The 
State of Health Disparities in the United States. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
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    The ability to improve understanding of and address racial and 
ethnic disparities in PAC outcomes requires the availability of better 
data. There is currently a Race and Ethnicity data element, collected 
in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single 
question, which aligns with the 1997 Office of Management and Budget 
(OMB) minimum data standards for federal data collection efforts.\170\ 
The 1997 OMB Standard lists five minimum categories of race: (1) 
American Indian or Alaska Native; (2) Asian; (3) Black or African 
American; (4) Native Hawaiian or Other Pacific Islander; (5) and White. 
The 1997 OMB Standard also lists two minimum categories of ethnicity: 
(1) Hispanic or Latino; and (2) Not Hispanic or Latino. The 2011 HHS 
Data Standards requires a two-question format when self-identification 
is used to collect data on race and ethnicity. Large federal surveys 
such as the National Health Interview Survey, Behavioral Risk Factor 
Surveillance System, and the National Survey on Drug Use and Health, 
have implemented the 2011 HHS race and ethnicity data standards. CMS 
has similarly updated the Medicare Current Beneficiary Survey, Medicare 
Health Outcomes Survey, and the Health Insurance Marketplace 
Application for Health Coverage with the 2011 HHS data standards. More 
information about the HHS Race and Ethnicity Data Standards are 
available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
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    \170\ ``Revisions to the Standards for the Classification of 
Federal Data on Race and Ethnicity (Notice of Decision)''. Federal 
Register 62:210 (October 30, 1997) pp. 58782-58790. Available from: 
https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf.
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    We are proposing to revise the current Race and Ethnicity data 
element for purposes of this proposal to conform to the 2011 HHS Data 
Standards for person-level data collection, while also meeting the 1997 
OMB minimum data standards for race and ethnicity. Rather than one data 
element that assesses both race and ethnicity, we are proposing two 
separate data elements: One for Race and one for Ethnicity, that would 
conform with the 2011 HHS Data Standards and the 1997 OMB Standard. In 
accordance with the 2011 HHS Data Standards, a two-question format 
would be used for the proposed race and ethnicity data elements.
    The proposed Race data element asks, ``What is your race?'' We are 
proposing to include 14 response options under the race data element: 
(1) White; (2) Black or African American; (3) American Indian or Alaska 
Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7) Japanese; (8) 
Korean; (9) Vietnamese; (10) Other Asian; (11) Native Hawaiian; (12) 
Guamanian or Chamorro; (13) Samoan; and, (14) Other Pacific Islander.
    The proposed Ethnicity data element asks, ``Are you Hispanic, 
Latino/a, or Spanish origin?'' We are proposing to include five 
response options under the ethnicity data element: (1) Not of Hispanic, 
Latino/a, or Spanish origin; (2) Mexican, Mexican American, Chicano; 
(3) Puerto Rican; (4) Cuban; and (5) Another Hispanic, Latino, or 
Spanish Origin.
    We believe that the two proposed data elements for race and 
ethnicity conform to the 2011 HHS Data Standards for person-level data 
collection, while also meeting the 1997 OMB minimum data standards for 
race and ethnicity, because under those standards, more detailed 
information on population groups can be collected if those additional 
categories can be aggregated into the OMB minimum standard set of 
categories.
    In addition, we received stakeholder feedback during the December 
13, 2018 SDOH listening session on the importance of improving response 
options for race and ethnicity as a component of health care 
assessments and for monitoring disparities. Some stakeholders 
emphasized the importance of allowing for self-identification of race 
and ethnicity for more categories than are included in the 2011 HHS 
Standard to better reflect state and local diversity, while 
acknowledging the burden of coding an open-ended health care assessment 
question across different settings.
    We believe that the proposed modified race and ethnicity data 
elements more accurately reflect the diversity of the U.S. population 
than the

[[Page 34681]]

current race/ethnicity data element included in MDS, LCDS, IRF-PAI, and 
OASIS.171 172 173 174 We believe, and research consistently 
shows, that improving how race and ethnicity data are collected is an 
important first step in improving quality of care and health outcomes. 
Addressing disparities in access to care, quality of care, and health 
outcomes for Medicare beneficiaries begins with identifying and 
analyzing how SDOH, such as race and ethnicity, align with disparities 
in these areas.\175\ Standardizing self-reported data collection for 
race and ethnicity allows for the equal comparison of data across 
multiple healthcare entities.\176\ By collecting and analyzing these 
data, CMS and other healthcare entities will be able to identify 
challenges and monitor progress. The growing diversity of the U.S. 
population and knowledge of racial and ethnic disparities within and 
across population groups supports the collection of more granular data 
beyond the 1997 OMB minimum standard for reporting categories. The 2011 
HHS race and ethnicity data standard includes additional detail that 
may be used by PAC providers to target quality improvement efforts for 
racial and ethnic groups experiencing disparate outcomes. For more 
information on the Race and Ethnicity data elements, we refer readers 
to the document titled ``Proposed Specifications for HH QRP Measures 
and Standardized Patient Assessment Data Elements,'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
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    \171\ Penman-Aguilar, A., Talih, M., Huang, D., Moonesinghe, R., 
Bouye, K., Beckles, G. (2016). Measurement of Health Disparities, 
Health Inequities, and Social Determinants of Health to Support the 
Advancement of Health Equity. J Public Health Manag Pract. 22 Suppl 
1: S33-42.
    \172\ Ramos, R., Davis, J.L., Ross, T., Grant, C.G., Green, B.L. 
(2012). Measuring health disparities and health inequities: Do you 
have REGAL data? Qual Manag Health Care. 21(3):176-87.
    \173\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
    \174\ ``Revision of Standards for Maintaining, Collecting, and 
Presenting Federal Data on Race and Ethnicity: Proposals From 
Federal Interagency Working Group (Notice and Request for 
Comments).'' Federal Register 82: 39 (March 1, 2017) p. 12242.
    \175\ National Academies of Sciences, Engineering, and Medicine; 
Health and Medicine Division; Board on Population Health and Public 
Health Practice; Committee on Community-Based Solutions to Promote 
Health Equity in the United States; Baciu A. Negussie Y. Geller A. 
et al., editors. Communities in Action: Pathways to Health Equity. 
Washington (DC): National Academies Press (US); 2017 Jan 11. 2, The 
State of Health Disparities in the United States. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK425844/.
    \176\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
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    In an effort to standardize the submission of race and ethnicity 
data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in 
section 1899B(a)(1)(B) of the Act, while minimizing the reporting 
burden, we are proposing to adopt the Race and Ethnicity data elements 
described previously as SPADEs with respect to the proposed Social 
Determinants of Health category.
    Specifically, we are proposing to replace the current Race/
Ethnicity data element, M0140, with the proposed Race and Ethnicity 
data elements. Due to the stable nature of Race/Ethnicity, we are 
proposing that HHAs that submit the Race and Ethnicity SPADEs with 
respect to SOC only will be deemed to have submitted those SPADEs with 
respect to SOC, ROC, and discharge, because it is unlikely that the 
assessment of those SPADEs with respect to SOC will differ from the 
assessment of the same SPADES with respect to ROC and discharge.
(2) Preferred Language and Interpreter Services
    More than 64 million Americans speak a language other than English 
at home, and nearly 40 million of those individuals have limited 
English proficiency (LEP).\177\ Individuals with LEP have been shown to 
receive worse care and have poorer health outcomes, including higher 
readmission rates.178 179 180 Communication with individuals 
with LEP is an important component of high quality health care, which 
starts by understanding the population in need of language services. 
Unaddressed language barriers between a patient and provider care team 
negatively affects the ability to identify and address individual 
medical and non-medical care needs, to convey and understand clinical 
information, as well as discharge and follow up instructions, all of 
which are necessary for providing high quality care. Understanding the 
communication assistance needs of patients with LEP, including 
individuals who are Deaf or hard of hearing, is critical for ensuring 
good outcomes.
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    \177\ U.S. Census Bureau, 2013-2017 American Community Survey 5-
Year Estimates.
    \178\ Karliner LS, Kim SE, Meltzer DO, Auerbach AD. Influence of 
language barriers on outcomes of hospital care for general medicine 
inpatients. J Hosp Med. 2010 May-Jun;5(5):276-82. doi: 10.1002/
jhm.658.
    \179\ Kim EJ, Kim T, Paasche-Orlow MK, et al. Disparities in 
Hypertension Associated with Limited English Proficiency. J Gen 
Intern Med. 2017 Jun;32(6):632-639. doi: 10.1007/s11606-017-3999-9.
    \180\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for social risk factors in Medicare payment: 
Identifying social risk factors. Washington, DC: The National 
Academies Press.
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    Presently, the preferred language of patients and need for 
interpreter services are assessed in two PAC assessment tools. The LCDS 
and the MDS use the same two data elements to assess preferred language 
and whether a patient or resident needs or wants an interpreter to 
communicate with health care staff. The MDS initially implemented 
preferred language and interpreter services data elements to assess the 
needs of SNF residents and patients and inform care planning. For 
alignment purposes, the LCDS later adopted the same data elements for 
LTCHs. The 2009 NASEM (formerly Institute of Medicine) report on 
standardizing data for health care quality improvement emphasizes that 
language and communication needs should be assessed as a standard part 
of health care delivery and quality improvement strategies.\181\
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    \181\ IOM (Institute of Medicine). 2009. Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement. 
Washington, DC: The National Academies Press.
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    In developing our proposal for a standardized language data element 
across PAC settings, we considered the current preferred language and 
interpreter services data elements that are in LCDS and MDS. We also 
considered the 2011 HHS Primary Language Data Standard and peer-
reviewed research. The current preferred language data element in LCDS 
and MDS asks, ``What is your preferred language?'' Because the 
preferred language data element is open-ended, the patient is able to 
identify their preferred language, including American Sign Language 
(ASL). Finally, we considered the recommendations from the 2009 NASEM 
(formerly Institute of Medicine) report, ``Race, Ethnicity, and 
Language Data: Standardization for Health Care Quality Improvement.'' 
In it, the committee recommended that organizations evaluating a 
patient's language and communication needs for health care purposes, 
should collect data on the preferred spoken language and on an 
individual's assessment of his/her level of English proficiency.
    A second language data element in LCDS and MDS asks, ``Do you want 
or need an interpreter to communicate with a doctor or health care 
staff?'' and

[[Page 34682]]

includes yes or no response options. In contrast, the 2011 HHS Primary 
Language Data Standard recommends either a single question to assess 
how well someone speaks English or, if more granular information is 
needed, a two-part question to assess whether a language other than 
English is spoken at home and if so, identify that language. However, 
neither option allows for a direct assessment of a patient's preferred 
spoken or written language nor whether they want or need interpreter 
services for communication with a doctor or care team, both of which 
are an important part of assessing patient needs and the care planning 
process. More information about the HHS Data Standard for Primary 
Language is available on the website at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=54.
    Research consistently recommends collecting information about an 
individual's preferred spoken language and evaluating those responses 
for purposes of determining language access needs in health care.\182\ 
However, using ``preferred spoken language'' as the metric does not 
adequately account for people whose preferred language is ASL, which 
would necessitate adopting an additional data element to identify 
visual language. The need to improve the assessment of language 
preferences and communication needs across PAC settings should be 
balanced with the burden associated with data collection on the 
provider and patient. Therefore we are proposing to use the Preferred 
Language and Interpreter Services data elements currently in use on the 
MDS and LCDS, on the OASIS.
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    \182\ Guerino, P. and James, C. Race, Ethnicity, and Language 
Preference in the Health Insurance Marketplaces 2017 Open Enrollment 
Period. Centers for Medicare & Medicaid Services, Office of Minority 
Health. Data Highlight: Volume 7--April 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf.
---------------------------------------------------------------------------

    In addition, we received feedback during the December 13, 2018 
listening session on the importance of evaluating and acting on 
language preferences early to facilitate communication and allowing for 
patient self-identification of preferred language. Although the 
discussion about language was focused on preferred spoken language, 
there was general consensus among participants that stated language 
preferences may or may not accurately indicate the need for interpreter 
services, which supports collecting and evaluating data to determine 
language preference, as well as the need for interpreter services. An 
alternate suggestion was made to inquire about preferred language 
specifically for discussing health or health care needs. While this 
suggestion does allow for ASL as a response option, we do not have data 
indicating how useful this question might be for assessing the desired 
information and thus we are not including this question in our 
proposal.
    Improving how preferred language and need for interpreter services 
data are collected is an important component of improving quality by 
helping PAC providers and other providers understand patient needs and 
develop plans to address them. For more information on the Preferred 
Language and Interpreter Services data elements, we refer readers to 
the document titled ``Proposed Specifications for HH QRP Measures and 
Standardized Patient Assessment Data Elements,'' available on the 
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of language data among 
IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the Preferred Language and Interpreter Services 
data elements currently used on the LCDS and MDS, and described 
previously, as SPADES with respect to the Social Determinants of Health 
category.
(3) Health Literacy
    The Department of Health and Human Services defines health literacy 
as ``the degree to which individuals have the capacity to obtain, 
process, and understand basic health information and services needed to 
make appropriate health decisions.'' \183\ Similar to language 
barriers, low health literacy can interfere with communication between 
the provider and patient and the ability for patients or their 
caregivers to understand and follow treatment plans, including 
medication management. Poor health literacy is linked to lower levels 
of knowledge about health, worse health outcomes, and the receipt of 
fewer preventive services, but higher medical costs and rates of 
emergency department use.\184\
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    \183\ U.S. Department of Health and Human Services, Office of 
Disease Prevention and Health Promotion. National action plan to 
improve health literacy. Washington (DC): Author; 2010.
    \184\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for social risk factors in Medicare payment: 
Identifying social risk factors. Washington, DC: The National 
Academies Press.
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    Health literacy is prioritized by Healthy People 2020 as an 
SDOH.\185\ Healthy People 2020 is a long-term, evidence-based effort 
led by the Department of Health and Human Services that aims to 
identify nationwide health improvement priorities and improve the 
health of all Americans. Although not designated as a social risk 
factor in NASEM's 2016 report on accounting for social risk factors in 
Medicare payment, the NASEM report noted that Health literacy is 
impacted by other social risk factors and can affect access to care as 
well as quality of care and health outcomes.\186\ Assessing for health 
literacy across PAC settings would facilitate better care coordination 
and discharge planning. A significant challenge in assessing the health 
literacy of individuals is avoiding excessive burden on patients and 
health care providers. The majority of existing, validated health 
literacy assessment tools use multiple screening items, generally with 
no fewer than four, which would make them burdensome if adopted in MDS, 
LCDS, IRF-PAI, and OASIS.
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    \185\ Social Determinants of Health. Healthy People 2020. 
https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
    \186\ U.S. Department of Health & Human Services, Office of the 
Assistant Secretary for Planning and Evaluation. Report to Congress: 
Social Risk Factors and Performance Under Medicare's Value-Based 
Purchasing Programs. Available at https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs. Washington, DC: 2016.
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    The Single Item Literacy Screener (SILS) question asks, ``How often 
do you need to have someone help you when you read instructions, 
pamphlets, or other written material from your doctor or pharmacy?'' 
Possible response options are: (1) Never; (2) Rarely; (3) Sometimes; 
(4) Often; and (5) Always. The SILS question, which assesses reading 
ability (a primary component of health literacy), tested reasonably 
well against the 36 item Short Test of Functional Health Literacy in 
Adults (S-TOFHLA), a thoroughly vetted and widely adopted health 
literacy test, in assessing the likelihood of low health literacy in an 
adult sample from primary care practices participating in the Vermont 
Diabetes Information System.187 188 The S-TOFHLA is a more

[[Page 34683]]

complex assessment instrument developed using actual hospital related 
materials such as prescription bottle labels and appointment slips, and 
often considered the instrument of choice for a detailed evaluation of 
health literacy.\189\ Furthermore, the S-TOFHLA instrument is 
proprietary and subject to purchase for individual entities or 
users.\190\ Given that SILS is publicly available, shorter and easier 
to administer than the full health literacy screen, and research found 
that a positive result on the SILS demonstrates an increased likelihood 
that an individual has low health literacy, we are proposing to use the 
single-item reading question for health literacy in the standardized 
data collection across PAC settings. We believe that use of this data 
element will provide sufficient information about the health literacy 
of HH patients to facilitate appropriate care planning, care 
coordination, and interoperable data exchange across PAC settings.
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    \187\ Morris, N.S., MacLean, C.D., Chew, L.D., & Littenberg, B. 
(2006). The Single Item Literacy Screener: evaluation of a brief 
instrument to identify limited reading ability. BMC family practice, 
7, 21. doi:10.1186/1471-2296-7-21.
    \188\ Brice, J.H., Foster, M.B., Principe, S., Moss, C., Shofer, 
F.S., Falk, R.J., Ferris, M.E., DeWalt, D.A. (2013). Single-item or 
two-item literacy screener to predict the S-TOFHLA among adult 
hemodialysis patients. Patient Educ Couns. 94(1):71-5.
    \189\ University of Miami, School of Nursing & Health Studies, 
Center of Excellence for Health Disparities Research. Test of 
Functional Health Literacy in Adults (TOFHLA). (March 2019). 
Available from: https://elcentro.sonhs.miami.edu/research/measures-library/tofhla/.
    \190\ 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.\191\ Given 
the dearth of Medicare data on health literacy and gaps in addressing 
health literacy in practice, we recommend the addition of a health 
literacy data element.
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    \191\ Hudson, S., Rikard, R.V., Staiculescu, I. & Edison, K. 
(2017). Improving health and the bottom line: The case for health 
literacy. In Building the case for health literacy: Proceedings of a 
workshop. Washington, DC: The National Academies Press.
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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.\192\ For more information on the proposed Health Literacy 
data element, we refer readers to the document titled ``Proposed 
Specifications for HH QRP Measures and Standardized Patient Assessment 
Data Elements,'' available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \192\ National Academies of Sciences, Engineering, and Medicine. 
2016. Accounting for Social Risk Factors in Medicare Payment: 
Identifying Social Risk Factors. Washington, DC: The National 
Academies Press.
---------------------------------------------------------------------------

    In an effort to standardize the submission of health literacy data 
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the SILS question, described previously for the 
Health Literacy data element, as SPADE under the Social Determinants of 
Health category. We are proposing to add the Health Literacy data 
element to the OASIS.
(4) Transportation
    Transportation barriers commonly affect access to necessary health 
care, causing missed appointments, delayed care, and unfilled 
prescriptions, all of which can have a negative impact on health 
outcomes.\193\ Access to transportation for ongoing health care and 
medication access needs, particularly for those with chronic diseases, 
is essential to successful chronic disease management. Adopting a data 
element to collect and analyze information regarding transportation 
needs across PAC settings would facilitate the connection to programs 
that can address identified needs. We are therefore proposing to adopt 
as SPADE a single transportation data element that is from the Protocol 
for Responding to and Assessing Patients' Assets, Risks, and 
Experiences (PRAPARE) assessment tool and currently part of the 
Accountable Health Communities (AHC) Screening Tool.
---------------------------------------------------------------------------

    \193\ Syed, S.T., Gerber, B.S., and Sharp, L.K. (2013). 
Traveling Towards Disease: Transportation Barriers to Health Care 
Access. J Community Health. 38(5): 976-993.
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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 are proposing to use the 
transportation data element from the PRAPARE Tool, with permission from 
National Association of Community Health Centers (NACHC), after 
considering research on the importance of addressing transportation 
needs as a critical SDOH.\194\
---------------------------------------------------------------------------

    \194\ Health Research & Educational Trust. (2017, November). 
Social determinants of health series: Transportation and the role of 
hospitals. Chicago, IL. Available at www.aha.org/transportation.www.aha.org/transportation.
---------------------------------------------------------------------------

    The proposed data element is responsive to research on the 
importance of addressing transportation needs as a critical SDOH and 
would adopt the Transportation item from the PRAPARE tool.\195\ This 
data element comes from the national PRAPARE social determinants of 
health assessment protocol, developed and owned by NACHC, in 
partnership with the Association of Asian Pacific Community Health 
Organization, the Oregon Primary Care Association, and the Institute 
for Alternative Futures. Similarly the Transportation data element used 
in the AHC Screening Tool was adapted from the PRAPARE tool. The AHC 
screening tool was implemented by the Center for Medicare and Medicaid 
Innovation's AHC Model and developed by a panel of interdisciplinary 
experts that looked at evidence-based ways to measure SDOH, including 
transportation. While the transportation access data element in the AHC 
screening tool serves the same purposes as our proposed SPADE 
collection about transportation barriers, the AHC tool has binary yes 
or no response options that do not differentiate between challenges for 
medical versus non-medical appointments and activities. We believe that 
this is an important nuance for informing PAC discharge planning to a 
community setting, as transportation needs for non-medical activities 
may differ than for medical activities and should be taken into 
account.\196\ We believe that use of this data element will provide 
sufficient information about transportation barriers to medical and 
non-medical care for HH patients to facilitate appropriate discharge 
planning and care coordination across PAC

[[Page 34684]]

settings. As such, we are proposing to adopt the Transportation data 
element from PRAPARE. More information about development of the PRAPARE 
tool is available on the website at https://protect2.fireeye.com/url?k=7cb6eb44-20e2f238-7cb6da7b-0cc47adc5fa2-1751cb986c8c2f8c&u=https://www.nachc.org/prapare.
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    \195\ Health Research & Educational Trust. (2017, November). 
Social determinants of health series: Transportation and the role of 
hospitals. Chicago, IL. Available at www.aha.org/transportation.
    \196\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
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    In addition, we received stakeholder feedback during the December 
13, 2018 SDOH listening session on the impact of transportation 
barriers on unmet care needs. While recognizing that there is no 
consensus in the field about whether providers should have 
responsibility for resolving patient transportation needs, discussion 
focused on the importance of assessing transportation barriers to 
facilitate connections with available community resources.
    Adding a Transportation data element to the collection of SPADE 
would be an important step to identifying and addressing SDOH that 
impact health outcomes and patient experience for Medicare 
beneficiaries. For more information on the Transportation data element, 
we refer readers to the document titled ``Proposed Specifications for 
HH QRP Measures and Standardized Patient Assessment Data Elements,'' 
available on the website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of transportation data 
among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 
1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we 
are proposing to adopt the Transportation data element described 
previously as SPADE with respect to the proposed Social Determinants of 
Health category. If finalized as proposed, we would add the 
Transportation data element to the OASIS.
(5) Social Isolation
    Distinct from loneliness, social isolation refers to an actual or 
perceived lack of contact with other people, such as living alone or 
residing in a remote area.197 198 Social isolation tends to 
increase with age, is a risk factor for physical and mental illness, 
and a predictor of mortality.199 200 201 Post-acute care 
providers are well-suited to design and implement programs to increase 
social engagement of patients, while also taking into account 
individual needs and preferences. Adopting a data element to collect 
and analyze information about social isolation for patients receiving 
HH services and across PAC settings would facilitate the identification 
of patients who are socially isolated and who may benefit from 
engagement efforts.
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    \197\ Tomaka, J., Thompson, S., and Palacios, R. (2006). The 
Relation of Social Isolation, Loneliness, and Social Support to 
Disease Outcomes Among the Elderly. J of Aging and Health. 18(3): 
359-384.
    \198\ Social Connectedness and Engagement Technology for Long-
Term and Post-Acute Care: A Primer and Provider Selection Guide. 
(2019). Leading Age. Available at https://www.leadingage.org/white-papers/social-connectedness-and-engagement-technology-long-term-and-post-acute-care-primer-and#1.1.
    \199\ Landeiro, F., Barrows, P., Nuttall Musson, E., Gray, A.M., 
and Leal, J. (2017). Reducing Social Loneliness in Older People: A 
Systematic Review Protocol. BMJ Open. 7(5): e013778.
    \200\ Ong, A.D., Uchino, B.N., and Wethington, E. (2016). 
Loneliness and Health in Older Adults: A Mini-Review and Synthesis. 
Gerontology. 62:443-449.
    \201\ Leigh-Hunt, N., Bagguley, D., Bash, K., Turner, V., 
Turnbull, S., Valtorta, N., and Caan, W. (2017). An overview of 
systematic reviews on the public health consequences of social 
isolation and loneliness. Public Health. 152:157-171.
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    We are proposing to adopt as SPADE a single social isolation data 
element that is currently part of the AHC Screening Tool. The AHC item 
was selected from the Patient-Reported Outcomes Measurement Information 
System (PROMIS[supreg]) Item Bank on Emotional Distress, and asks, 
``How often do you feel lonely or isolated from those around you?'' The 
five response options are: (1) Never; (2) Rarely; (3) Sometimes; (4) 
Often; and (5) Always.\202\ The AHC Screening Tool was developed by a 
panel of interdisciplinary experts that looked at evidence-based ways 
to measure SDOH, including social isolation. More information about the 
AHC Screening Tool is available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
---------------------------------------------------------------------------

    \202\ Northwestern University. (2017). PROMIS Item Bank v. 1.0--
Emotional Distress--Anger--Short Form 1.
---------------------------------------------------------------------------

    In addition, we received stakeholder feedback during the December 
13, 2018 SDOH listening session on the value of receiving information 
on social isolation for purposes of care planning. Some stakeholders 
also recommended assessing social isolation as an SDOH as opposed to 
social support.
    The proposed Social Isolation data element is consistent with NASEM 
considerations about social isolation as a function of social 
relationships that impacts health outcomes and increases mortality 
risk, as well as the current work of a NASEM committee examining how 
social isolation and loneliness impact health outcomes in adults 50 
years and older. We believe that adding a Social Isolation data element 
would be an important component of better understanding patient 
complexity and the care goals of patients, thereby facilitating care 
coordination and continuity in care planning across PAC settings. For 
more information on the Social Isolation data element, we refer readers 
to the document titled ``Proposed Specifications for HH QRP Measures 
and Standardized Patient Assessment Data Elements,'' available on the 
website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    In an effort to standardize the submission of data about social 
isolation among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined 
in section 1899B(a)(1)(B) of the Act, while minimizing the reporting 
burden, we are proposing to adopt the Social Isolation data element 
described previously as SPADE with respect to the proposed Social 
Determinants of Health category. We are proposing to add the Social 
Isolation data element to the OASIS.

J. Proposed Codification of the Home Health Quality Reporting Program 
Requirements

    To promote alignment of the HH QRP and the SNF QRP, IRF QRP, and 
LTCH QRP regulatory text, we believe that with the exception of the 
provision governing the 2 percentage point reduction to the update of 
the unadjusted national standardized prospective payment rate, it is 
appropriate to codify the requirements that apply to the HH QRP in a 
single section of our regulations. Accordingly, we are proposing to 
amend 42 CFR chapter IV, subchapter G by creating a new Sec.  484.245, 
titled ``Home Health Quality Reporting Program''.
    The provisions we are proposing to codify are as follows:
     The HH QRP participation requirements at Sec.  484.245(a) 
(72 FR 49863).
     The HH QRP data submission requirements at Sec.  
484.245(b)(1), including--
    ++ Data on measures specified under section 1899B(c)(1) and 
1899B(d)(1) of the Act;
    ++ Standardized patient assessment data required under section 
1899B(b)(1) of the Act (82 FR 51735 through 51736); and
    ++ Quality data specified under section 1895(b)(3)(B)(v)(II) of the 
Act including the HHCAHPS survey data submission requirements at Sec.  
484.245(b)(1)(iii)(A) through (E)

[[Page 34685]]

(redesignated from Sec.  484.250(b) through (c)(3) and striking Sec.  
484.250(a)(2)).
     The HH QRP data submission form, manner, and timing 
requirements at Sec.  484.245(b)(2).
     The HH QRP exceptions and extension requirements at Sec.  
484.245(c) (redesignated from Sec.  484.250(d)(1) through (d)(4)(ii)).
     The HH QRP's reconsideration policy at Sec.  484.245(d) 
(redesignated from Sec.  484.250(e)(1) through (4)).
     The HH QRP appeals policy at Sec.  484.245(e) 
(redesignated from Sec.  484.250(f)).
    We also note the following codification proposals:
     The addition of the HHCAHPS and HH QRP acronyms to the 
definitions at Sec.  484.205.
     The removal of the regulatory provision in Sec.  
484.225(b) regarding the unadjusted national prospective 60-day episode 
rate for HHAs that submit their quality data as specified by the 
Secretary.
     The redesignation of the regulatory provision in Sec.  
484.225(c) to Sec.  484.225(b) regarding the unadjusted national 
prospective 60-day episode rate for HHAs that do not submit their 
quality data as specified by the Secretary.
     The redesignation of the regulatory provision in Sec.  
484.225(d) to Sec.  484.225(c) regarding the national, standardized 
prospective 30-day payment amount. The cross-reference in newly 
redesignated paragraph (c) would also be revised.

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

    We are proposing to remove Question 10 from all HHCAHPS Surveys 
(both mail surveys and telephone surveys) which says, ``In the last 2 
months of care, did you and a home health provider from this agency 
talk about pain?'' which is one of seven questions (they are questions 
3, 4, 5, 10, 12, 13 and 14) in the ``Special Care Issues'' composite 
measure, beginning July 1, 2020. The ``Special Care Issues'' composite 
measure also focuses on home health agency staff discussing home 
safety, the purpose of the medications that are being taken, side 
effects of medications, and when to take medications. In the initial 
development of the HHCAHPS Survey, this question was included in the 
survey since home health agency staff talk about pain to identify any 
emerging issues (for example, wounds that are getting worse) every time 
they see their home health patients.
    We are proposing to remove pain questions from the HHCAHPS Survey 
and pain items from the OASIS data sets to avoid potential unintended 
consequences that may arise from their inclusion in CMS surveys and 
datasets. The reason that CMS is proposing removing this particular 
pain question is consistent with the proposed removal of pain items 
from OASIS in section IV.D.1. of this proposed rule and also consistent 
with the removal of pain items from the Hospital CAHPS Survey. The 
removal of pain questions from CMS surveys and removal of pain items 
from CMS data sets is to avoid potential unintended consequences that 
arise from their inclusion in CMS surveys and datasets. We welcome 
comments about the proposed removal of Q10 from the HHCAHPS Survey. In 
the initial development of the HHCAHPS Survey, this question was 
included in the survey, and, consequently, from the ``Special Care 
Issues'' measure. The HHCAHPS Survey is available on the official 
website for HHCAHPS, at https://homehealthcahps.org.

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

1. Background
    Section 484.250(a), requires HHAs to submit OASIS data and Home 
Health Care Consumer Assessment of Healthcare Providers and Systems 
Survey (HHCAHPS) data to meet the quality reporting requirements of 
section 1895(b)(3)(B)(v) of the Act. Not all OASIS data described in 
Sec.  484.55(b) and (d) are necessary for purposes of complying with 
the quality reporting requirements of section 1895(b)(3)(B)(v) of the 
Act. OASIS data items may be used for other purposes unrelated to the 
HH QRP, including payment, survey and certification, the HH VBP Model, 
or care planning. Any OASIS data that are not submitted for the 
purposes of the HH QRP are not used for purposes of determining HH QRP 
compliance.
2. Proposed Schedule for Reporting the Transfer of Health Information 
Quality Measures Beginning With the CY 2022 HH QRP
    As discussed in section V.E. of this proposed rule, we are 
proposing to adopt the Transfer of Health Information to Provider-Post-
Acute Care (PAC) and Transfer of Health Information to Patient-Post-
Acute Care (PAC) quality measures beginning with the CY 2022 HH QRP. We 
are also proposing that HHAs would report the data on those measures 
using the OASIS. We are proposing that HHAs would be required to 
collect data on both measures for patients beginning with patients 
discharged or transferred on or after January 1, 2021. HHAs would be 
required to report these data for the CY 2022 HH QRP at discharge and 
transfer between January 1, 2021 and June 30, 2021. Following the 
initial reporting period for the CY 2022 HH QRP, subsequent years for 
the HH QRP would be based on 12 months of such data reporting beginning 
with July 1, 2021 through June 30, 2022 for the CY 2023 HH QRP.
3. Proposed Schedule for Reporting Standardized Patient Assessment Data 
Elements Beginning With the CY 2022 HH QRP
    As discussed in section V.G. of this proposed rule, we are 
proposing to adopt additional SPADEs beginning with the CY 2022 HH QRP. 
We are proposing that HHAs would report the data using the OASIS. HHAs 
would be required to collect the SPADEs for episodes beginning or 
ending on or after January 1, 2021. We are also proposing that HHAs 
that submit the Hearing, Vision, Race, and Ethnicity SPADEs with 
respect to SOC will be deemed to have submitted those SPADEs with 
respect to SOC, ROC, and discharge, because it is unlikely that the 
assessment of those SPADEs with respect to SOC will differ from the 
assessment of the same SPADES with respect to ROC or discharge. HHAs 
would be required to report the remaining SPADES for the CY 2022 HH QRP 
at SOC, ROC, and discharge time points between January 1, 2021 and June 
30, 2021. Following the initial reporting period for the CY 2022 HH 
QRP, subsequent years for the HH QRP would be based on 12 months of 
such data reporting beginning with July 1, 2021 through June 30, 2022 
for the CY 2023 HH QRP.
4. Input Sought To Expand the Reporting of OASIS Data Used for the HH 
QRP To Include Data on All Patients Regardless of Their Payer
    We continue to believe that the reporting of all-payer data under 
the HH QRP would add value to the program and provide a more accurate 
representation of the quality provided by HHA's. In the CY 2018 HH PPS 
final rule (82 FR 51736 through 51737), we received and responded to 
comments sought for data reporting related to assessment based 
measures, specifically on whether we should require quality data 
reporting on all HH patients, regardless of payer, where feasible. 
Several commenters supported data collection of all patients regardless 
of payer but other commenters did express concerns about the burden 
imposed on the HHAs as a result of OASIS reporting

[[Page 34686]]

for all patients, including healthcare professionals spending more time 
with documentation and less time providing patient care, and the need 
to increase staff hours or hire additional staff. A commenter requested 
CMS provide additional explanation of what the benefit would be to 
collecting OASIS data on all patients regardless of payer.
    We are sensitive to the issue of burden associated with data 
collection and acknowledge concerns about the additional burden 
required to collect quality data on all patients. We are aware that 
while some providers use a separate assessment for private payers, many 
HHA's currently collect OASIS data on all patients regardless of payer 
to assist with clinical and work flow implications associated with 
maintaining two distinct assessments. We believe collecting OASIS data 
on all patients regardless of payer will allow us to ensure data that 
is representative of quality provided to all patients in the HHA 
setting and therefore, allow us to better determine whether HH Medicare 
beneficiaries receive the same quality of care that other patients 
receive. We also believe it is the overall goal of the IMPACT Act to 
standardize data and measures in the four PAC programs to permit 
longitudinal analysis of the data. The absence of all payer data limits 
CMS's ability to compare all patients receiving services in each PAC 
setting, as was intended by the Act.
    We plan to propose to expand the reporting of OASIS data used for 
the HH QRP to include data on all patients, regardless of their payer, 
in future rulemaking. Collecting data on all HHA patients, regardless 
of their payer would align our data collection requirements under the 
HH QRP with the data collection requirements currently adopted for the 
Long-Term Care Hospital (LTCH) QRP and the Hospice QRP. Additionally, 
collection of data on all patients, regardless of their payer is 
currently being proposed in the FY 2020 rules for the Skilled Nursing 
Facility (SNF) QRP (84 FR 17678 through 17679) and the Inpatient 
Rehabilitation Facilities (IRF) QRP (84 FR 17326 through 17327). To 
assist us regarding a future proposal, we are seeking input on the 
following questions related to requiring quality data reporting on all 
HH patients, regardless of payer:
     Do you agree there is a need to collect OASIS data for the 
HH QRP on all patients regardless of payer?
     What percentage of your HHA's patients are you not 
currently reporting OASIS data for the HH QRP?
     Are there burden issues that need to be considered 
specific to the reporting of OASIS data on all HH patients, regardless 
of their payer?
     What differences, if any, do you notice in patient mix or 
in outcomes between those patients that you currently report OASIS 
data, and those patients that you do not report data for the HH QRP?
     Are there other factors that should be considered prior to 
proposing to expand the reporting of OASIS data used for the HH QRP to 
include data on all patients, regardless of their payer?
    As stated previously, there is no proposal in this rule to expand 
the reporting of OASIS data used for the HH QRP to include data on all 
HHA patients regardless of payer. However we look forward to receiving 
comments on this topic, including the questions noted previously, and 
will take all recommendations received into consideration.

VI. Medicare Coverage of Home Infusion Therapy Services

A. Background and Overview

1. Background
    Section 5012 of the 21st Century Cures Act (``the Cures Act'') 
(Pub. L. 114-255), which amended sections 1861(s)(2) and 1861(iii) of 
the Act, established a new Medicare home infusion therapy benefit. The 
Medicare home infusion therapy benefit covers the professional 
services, including nursing services, furnished in accordance with the 
plan of care, patient training and education (not otherwise covered 
under the durable medical equipment benefit), remote monitoring, and 
monitoring services for the provision of home infusion therapy and home 
infusion drugs furnished by a qualified home infusion therapy supplier. 
This benefit will ensure consistency in coverage for home infusion 
benefits for all Medicare beneficiaries.
    Section 50401 of the BBA of 2018 amended section 1834(u) of the Act 
by adding a new paragraph (7) that establishes a home infusion therapy 
services temporary transitional payment for eligible home infusion 
suppliers for certain items and services furnished in coordination with 
the furnishing of transitional home infusion drugs beginning January 1, 
2019. This temporary payment covers the cost of the same items and 
services, as defined in section 1861(iii)(2)(A) and (B) of the Act, 
related to the administration of home infusion drugs. The temporary 
transitional payment began on January 1, 2019 and will end the day 
before the full implementation of the home infusion therapy benefit on 
January 1, 2021, as required by section 5012 of the 21st Century Cures 
Act.
    In the CY 2019 HH PPS final rule (83 FR 32340), we finalized the 
implementation of temporary transitional payments for home infusion 
therapy services to begin on January 1, 2019. In addition, we 
implemented the establishment of regulatory authority for the oversight 
of national accrediting organizations (AOs) that accredit home infusion 
therapy suppliers, and their CMS-approved home infusion therapy 
accreditation programs.
2. Overview of Infusion Therapy
    Infusion drugs can be administered in multiple health care 
settings, including inpatient hospitals, skilled nursing facilities 
(SNFs), hospital outpatient departments (HOPDs), physicians' offices, 
and in the home. Traditional fee-for-service (FFS) Medicare provides 
coverage for infusion drugs, equipment, supplies, and administration 
services. However, Medicare coverage requirements and payment vary for 
each of these settings. Infusion drugs, equipment, supplies, and 
administration are all covered by Medicare in the inpatient hospital, 
SNFs, HOPDs, and physicians' offices.
    Generally, Medicare payment under Part A for the drugs, equipment, 
supplies, and services are bundled, meaning a single payment is made on 
the basis of expected costs for clinically-defined episodes of care. 
For example, if a beneficiary is receiving an infusion drug during an 
inpatient hospital stay, the Part A payment for the drug, supplies, 
equipment, and drug administration is included in the diagnosis-related 
group (DRG) payment to the hospital under the Medicare inpatient 
prospective payment system. Beneficiaries are liable for the Medicare 
inpatient hospital deductible and no coinsurance for the first 60 days. 
Similarly, if a beneficiary is receiving an infusion drug while in a 
SNF under a Part A stay, the payment for the drug, supplies, equipment, 
and drug administration are included in the SNF prospective payment 
system payment. After 20 days of SNF care, there is a daily beneficiary 
cost-sharing amount through day 100 when the beneficiary becomes 
responsible for all costs for each day after day 100 of the benefit 
period.
    Under Medicare Part B, certain items and services are paid 
separately while other items and services may be packaged into a single 
payment together. For example, in an HOPD and in a physician's office, 
the drug is paid separately, generally at the average sales price (ASP) 
plus 6 percent (77 FR

[[Page 34687]]

68210).\203\ Medicare also makes a separate payment to the physician or 
hospital outpatient departments (HOPD) for administering the drug. The 
separate payment for infusion drug administration in an HOPD and in a 
physician's office generally includes a base payment amount for the 
first hour and a payment add-on that is a different amount for each 
additional hour of administration. The beneficiary is responsible for 
the 20 percent coinsurance under Medicare Part B.
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    \203\ https://www.govinfo.gov/content/pkg/FR-2012-11-15/pdf/2012-26902.pdf.
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    Medicare FFS covers outpatient infusion drugs under Part B, 
``incident to'' a physician's service, provided the drugs are not 
usually self-administered by the patient. Drugs that are ``not usually 
self-administered,'' are defined in our manual according to how the 
Medicare population as a whole uses the drug, not how an individual 
patient or physician may choose to use a particular drug. For the 
purpose of this exclusion, the term ``usually'' means more than 50 
percent of the time for all Medicare beneficiaries who use the drug. 
The term ``by the patient'' means Medicare beneficiaries as a 
collective whole. Therefore, if a drug is self-administered by more 
than 50 percent of Medicare beneficiaries, the drug is generally 
excluded from Part B coverage. This determination is made on a drug-by-
drug basis, not on a beneficiary-by-beneficiary basis.\204\ The MACs 
update Self-Administered Drug (SAD) exclusion lists on a quarterly 
basis.\205\
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    \204\ Medicare Benefit Policy Manual, chapter 15, ``Covered 
Medical and Other Health Services'', section 50.2--Determining Self-
Administration of Drug or Biological found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
    \205\ www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?bc=AQAAAAAAAAAAAA%3D%3D.
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    Home infusion therapy involves the intravenous or subcutaneous 
administration of drugs or biologicals to an individual at home. 
Certain drugs can be infused in the home, but the nature of the home 
setting presents different challenges than the settings previously 
described. Generally, the components needed to perform home infusion 
include the drug (for example, antivirals, immune globulin), equipment 
(for example, a pump), and supplies (for example, tubing and 
catheters). Likewise, nursing services are usually necessary to train 
and educate the patient and caregivers on the safe administration of 
infusion drugs in the home. Visiting nurses often play a large role in 
home infusion. These nurses typically train the patient or caregiver to 
self-administer the drug, educate on side effects and goals of therapy, 
and visit periodically to assess the infusion site and provide dressing 
changes. Depending on patient acuity or the complexity of the drug 
administration, certain infusions may require more training and 
education, especially those that require special handling or pre-or 
post-infusion protocols. The home infusion process typically requires 
coordination among multiple entities, including patients, physicians, 
hospital discharge planners, health plans, home infusion pharmacies, 
and, if applicable, home health agencies.
    With regard to payment for home infusion therapy under traditional 
Medicare, drugs are generally covered under Part B or Part D. Certain 
infusion pumps, supplies (including home infusion drugs and the 
services required to furnish the drug, (that is, preparation and 
dispensing), and nursing are covered in some circumstances through the 
Part B durable medical equipment (DME) benefit, the Medicare home 
health benefit, or some combination of these benefits. In accordance 
with section 50401 of the Bipartisan Budget Act (BBA) of 2018, 
beginning on January 1, 2019, for CYs 2019 and 2020, Medicare 
implemented temporary transitional payments for home infusion therapy 
services furnished in coordination with the furnishing of transitional 
home infusion drugs. This payment, for home infusion therapy services, 
is only made if a beneficiary is furnished certain drugs and 
biologicals administered through an item of covered DME, and payable 
only to suppliers enrolled in Medicare as pharmacies that provide 
external infusion pumps and external infusion pump supplies (including 
the drug). With regard to the coverage of the home infusion drugs, 
Medicare Part B covers a limited number of home infusion drugs through 
the DME benefit if: (1) The drug is necessary for the effective use of 
an external infusion pump classified as DME and determined to be 
reasonable and necessary for administration of the drug; and (2) the 
drug being used with the pump is itself reasonable and necessary for 
the treatment of an illness or injury. Additionally, in order for the 
infusion pump to be covered under the DME benefit, it must be 
appropriate for use in the home (Sec.  414.202).
    Only certain types of infusion pumps are covered under the DME 
benefit. The Medicare National Coverage Determinations Manual, chapter 
1, part 4, section 280.14 describes the types of infusion pumps that 
are covered under the DME benefit.\206\ For DME external infusion 
pumps, Medicare Part B covers the infusion drugs and other supplies and 
services necessary for the effective use of the pump. Through the Local 
Coverage Determination (LCD) for External Infusion Pumps (L33794), the 
DME Medicare administrative contractors (MACs) specify the details of 
which infusion drugs are covered with these pumps. Examples of covered 
Part B DME infusion drugs include, among others, certain IV drugs for 
heart failure and pulmonary arterial hypertension, immune globulin for 
primary immune deficiency (PID), insulin, antifungals, antivirals, and 
chemotherapy, in limited circumstances.
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    \206\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
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3. Home Infusion Therapy Legislation
a. 21st Century Cures Act
    Effective January 1, 2021, section 5012 of the 21st Century Cures 
Act (Pub. L. 114-255) (Cures Act) created a separate Medicare Part B 
benefit category under section 1861(s)(2)(GG) of the Act for coverage 
of home infusion therapy services needed for the safe and effective 
administration of certain drugs and biologicals administered 
intravenously, or subcutaneously for an administration period of 15 
minutes or more, in the home of an individual, through a pump that is 
an item of DME. The infusion pump and supplies (including home infusion 
drugs) will continue to be covered under the Part B DME benefit. 
Section 1861(iii)(2) of the Act defines home infusion therapy to 
include the following items and services: The professional services, 
including nursing services, furnished in accordance with the plan, 
training and education (not otherwise paid for as DME), remote 
monitoring, and other monitoring services for the provision of home 
infusion therapy and home infusion drugs furnished by a qualified home 
infusion therapy supplier, which are furnished in the individual's 
home. Section 1861(iii)(3)(B) of the Act defines the patient's home to 
mean a place of residence used as the home of an individual as defined 
for purposes of section 1861(n) of the Act. As outlined in section 
1861(iii)(1) of the Act, to be eligible to receive home infusion 
therapy services under the home infusion therapy benefit, the patient 
must be under the care of an applicable provider (defined in section 
1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or 
physician's assistant), and the patient must be under a physician-
established plan of care that

[[Page 34688]]

prescribes the type, amount, and duration of infusion therapy services 
that are to be furnished. The plan of care must be periodically 
reviewed by the physician in coordination with the furnishing of home 
infusion drugs (as defined in section 1861(iii)(3)(C) of the Act). 
Section 1861(iii)(3)(C) of the Act defines a ``home infusion drug'' 
under the home infusion therapy benefit as a drug or biological 
administered intravenously, or subcutaneously for an administration 
period of 15 minutes or more, in the patient's home, through a pump 
that is an item of DME as defined under section 1861(n) of the Act. 
This definition does not include insulin pump systems or any self-
administered drug or biological on a self-administered drug exclusion 
list.
    Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home 
infusion therapy supplier'' as a pharmacy, physician, or other provider 
of services or supplier licensed by the state in which supplies or 
services are furnished. The provision specifies qualified home infusion 
therapy suppliers must furnish infusion therapy to individuals with 
acute or chronic conditions requiring administration of home infusion 
drugs; ensure the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; be 
accredited by an organization designated by the Secretary; and meet 
other such requirements as the Secretary deems appropriate, taking into 
account the standards of care for home infusion therapy established by 
Medicare Advantage (MA) plans under Part C and in the private sector. 
The supplier may subcontract with a pharmacy, physician, other 
qualified supplier or provider of medical services, in order to meet 
these requirements.
    Section 1834(u)(1) of the Act requires the Secretary to implement a 
payment system under which, beginning January 1, 2021, a single payment 
is made to a qualified home infusion therapy supplier for the items and 
services (professional services, including nursing services; training 
and education; remote monitoring, and other monitoring services). The 
single payment must take into account, as appropriate, types of 
infusion therapy, including variations in utilization of services by 
therapy type. In addition, the single payment amount is required to be 
adjusted to reflect geographic wage index and other costs that may vary 
by region, patient acuity, and complexity of drug administration. The 
single payment may be adjusted to reflect outlier situations, and other 
factors as deemed appropriate by the Secretary, which are required to 
be done in a budget-neutral manner. Section 1834(u)(2) of the Act 
specifies certain items that ``the Secretary may consider'' in 
developing the HIT payment system: ``the costs of furnishing infusion 
therapy in the home, consult[ation] with home infusion therapy 
suppliers, . . . payment amounts for similar items and services under 
this part and part A, and . . . payment amounts established by Medicare 
Advantage plans under part C and in the private insurance market for 
home infusion therapy (including average per treatment day payment 
amounts by type of home infusion therapy)''. Section 1834(u)(3) of the 
Act specifies that annual updates to the single payment are required to 
be made, beginning January 1, 2022, by increasing the single payment 
amount by the percent increase in the Consumer Price Index for all 
urban consumers (CPI-U) for the 12-month period ending with June of the 
preceding year, reduced by the 10-year moving average of changes in 
annual economy-wide private nonfarm business multifactor productivity 
(MFP). Under section 1834(u)(1)(A)(iii), the single payment amount for 
each infusion drug administration calendar day, including the required 
adjustments and the annual update, cannot exceed the amount determined 
under the fee schedule under section 1848 of the Act for infusion 
therapy services if furnished in a physician's office. This statutory 
provision limits the single payment amount so that it cannot reflect 
more than 5 hours of infusion for a particular therapy per calendar 
day. Section 1834(u)(4) of the Act also allows the Secretary 
discretion, as appropriate, to consider prior authorization 
requirements for home infusion therapy services. Finally, section 
5012(c)(3) of the 21st Century Cures Act amended section 1861(m) of the 
Act to exclude home infusion therapy from the HH PPS beginning on 
January 1, 2021.
b. Bipartisan Budget Act of 2018
    Section 50401 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123) amended section 1834(u) of the Act by adding a new paragraph (7) 
that established a home infusion therapy services temporary 
transitional payment for eligible home infusion suppliers for certain 
items and services furnished in coordination with the furnishing of 
transitional home infusion drugs, beginning January 1, 2019. This 
payment covers the same items and services as defined in section 
1861(iii)(2)(A) and (B) of the Act, furnished in coordination with the 
furnishing of transitional home infusion drugs. Section 
1834(u)(7)(A)(iii) of the Act defines the term ``transitional home 
infusion drug'' using the same definition as ``home infusion drug'' 
under section 1861(iii)(3)(C) of the Act, which is a parenteral drug or 
biological administered intravenously, or subcutaneously for an 
administration period of 15 minutes or more, in the home of an 
individual through a pump that is an item of DME as defined under 
section 1861(n) of the Act. The definition of ``home infusion drug'' 
excludes ``a self-administered drug or biological on a self-
administered drug exclusion list'' but the definition of ``transitional 
home infusion drug'' notes that this exclusion shall not apply if a 
drug described in such clause is identified in clauses (i), (ii), (iii) 
or (iv) of 1834(u)(7)(C) of the Act. Section 1834(u)(7)(C) of the Act 
sets out the Healthcare Common Procedure Coding System (HCPCS) codes 
for the drugs and biologicals covered under the DME LCD for External 
Infusion Pumps (L33794), as the drugs covered during the temporary 
transitional period. In addition, section 1834(u)(7)(C) of the Act 
states that the Secretary shall assign to an appropriate payment 
category drugs which are covered under the DME LCD for External 
Infusion Pumps and billed under HCPCS codes J7799 (Not otherwise 
classified drugs, other than inhalation drugs, administered through 
DME) and J7999 (Compounded drug, not otherwise classified), or billed 
under any code that is implemented after the date of the enactment of 
this paragraph and included in such local coverage determination or 
included in sub-regulatory guidance as a home infusion drug.
    Section 1834(u)(7)(E)(i) of the Act states that payment to an 
eligible home infusion supplier or qualified home infusion therapy 
supplier for an infusion drug administration calendar day in the 
individual's home refers to payment only for the date on which 
professional services, as described in section 1861(iii)(2)(A) of the 
Act, were furnished to administer such drugs to such individual. This 
includes all such drugs administered to such individual on such day. 
Section 1842(u)(7)(F) of the Act defines ``eligible home infusion 
supplier'' as a supplier who is enrolled in Medicare as a pharmacy that 
provides external infusion pumps and external infusion pump supplies, 
and that maintains all pharmacy licensure requirements in the State in 
which the applicable infusion drugs are administered.
    As set out at section 1834(u)(7)(C) of the Act, identified HCPCS 
codes for transitional home infusion drugs are assigned to three 
payment categories, as

[[Page 34689]]

identified by their corresponding HCPCS codes, for which a single 
amount will be paid for home infusion therapy services furnished on 
each infusion drug administration calendar day. Payment category 1 
includes certain intravenous infusion drugs for therapy, prophylaxis, 
or diagnosis, including antifungals and antivirals; inotropic and 
pulmonary hypertension drugs; pain management drugs; and chelation 
drugs. Payment category 2 includes subcutaneous infusions for therapy 
or prophylaxis, including certain subcutaneous immunotherapy infusions. 
Payment category 3 includes intravenous chemotherapy infusions, 
including certain chemotherapy drugs and biologicals. The payment 
category for subsequent transitional home infusion drug additions to 
the LCD and compounded infusion drugs not otherwise classified, as 
identified by HCPCS codes J7799 and J7999, will be determined by the 
DME MACs.
    In accordance with section 1834(u)(7)(D) of the Act, each payment 
category is paid at amounts in accordance with the Physician Fee 
Schedule (PFS) for each infusion drug administration calendar day in 
the individual's home for drugs assigned to such category, without 
geographic adjustment. Section 1834(u)(7)(E)(ii) of the Act requires 
that in the case that two (or more) home infusion drugs or biologicals 
from two different payment categories are administered to an individual 
concurrently on a single infusion drug administration calendar day, one 
payment for the highest payment category will be made.
4. Summary of CY 2019 Home Infusion Therapy Provisions
    In the CY 2019 Home Health Prospective Payment System (HH PPS) 
final rule (83 FR 56579) we finalized the implementation of the home 
infusion therapy services temporary transitional payments under 
paragraph (7) of section 1834(u) of the Act. These services are 
furnished in the individual's home to an individual who is under the 
care of an applicable provider (defined in section 1861(iii)(3)(A) of 
the Act as a physician, nurse practitioner, or physician's assistant) 
and where there is a plan of care established and periodically reviewed 
by a physician prescribing the type, amount, and duration of infusion 
therapy services. Only eligible home infusion suppliers can bill for 
the temporary transitional payments. Therefore, in accordance with 
section 1834(u)(7)(F) of the Act, we clarified that this means that 
existing DME suppliers that are enrolled in Medicare as pharmacies that 
provide external infusion pumps and external infusion pump supplies, 
who comply with Medicare's DME Supplier and Quality Standards, and 
maintain all pharmacy licensure requirements in the State in which the 
applicable infusion drugs are administered, are considered eligible 
home infusion suppliers.
    Section 1834(u)(7)(C) of the Act assigns transitional home infusion 
drugs, identified by the HCPCS codes for the drugs and biologicals 
covered under the DME LCD for External Infusion Pumps (L33794),\207\ 
into three payment categories, for which we established a single 
payment amount in accordance with section 1834(u)(7)(D) of the Act. 
This section states that each single payment amount per category will 
be paid at amounts equal to the amounts determined under the PFS 
established under section 1848 of the Act for services furnished during 
the year for codes and units of such codes, without geographic 
adjustment. Therefore, we created a new HCPCS G-code for each of the 
three payment categories and finalized the billing procedure for the 
temporary transitional payment for eligible home infusion suppliers. We 
stated that the eligible home infusion supplier would submit, in line-
item detail on the claim, a G-code for each infusion drug 
administration calendar day. The claim should include the length of 
time, in 15-minute increments, for which professional services were 
furnished. The G-codes can be billed separately from, or on the same 
claim as, the DME, supplies, or infusion drug, and are processed 
through the DME MACs. On August 10, 2018, we issued Change Request: 
R4112CP: Temporary Transitional Payment for Home Infusion Therapy 
Services for CYs 2019 and 2020 \208\ outlining the requirements for the 
claims processing changes needed to implement this payment.
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    \207\ https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794&ver=83&Date=05%2f15%2f2019&DocID=L33794&bc=iAAAABAAAAAA&.
    \208\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
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    And finally, we finalized the definition of ``infusion drug 
administration calendar day'' in regulation as the day on which home 
infusion therapy services are furnished by skilled professional(s) in 
the individual's home on the day of infusion drug administration. The 
skilled services provided on such day must be so inherently complex 
that they can only be safely and effectively performed by, or under the 
supervision of, professional or technical personnel (42 CFR 486.505). 
Section 1834(u)(7)(E)(i) of the Act clarifies that this definition is 
with respect to the furnishing of ``transitional home infusion drugs'' 
and ``home infusion drugs'' to an individual by an ``eligible home 
infusion supplier'' and a ``qualified home infusion therapy supplier.'' 
The definition of ``infusion drug administration calendar day'' applies 
to both the temporary transitional payment in CYs 2019 and 2020 and the 
permanent home infusion therapy benefit to be implemented beginning in 
CY 2021. Although we finalized this definition in regulation in the CY 
2019 HH PPS final rule with comment (83 FR 56583), we stated that we 
would carefully monitor the effects of this definition on access to 
care and we stated that, if warranted and if within the limits of our 
statutory authority, we would engage in additional rulemaking our 
guidance regarding this definition. In that same rule, we also 
solicited additional comments on this interpretation and on its effects 
on access to care. We have been monitoring utilization of home infusion 
therapy services beginning on January 1, 2019; however, we do not have 
sufficient data on utilization yet to determine the effects on access 
to care. We will be addressing those comments received in response to 
the CY 2019 HH PPS final rule with comment as well as those received 
for this proposed rule in the CY 2020 HH PPS final rule.

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

    As previously noted, section 50401 of the BBA of 2018 amended 
section 1834(u) of the Act by adding a new paragraph (7) that 
established a home infusion therapy services temporary transitional 
payment for eligible home infusion suppliers for certain items and 
services furnished to administer home infusion drugs beginning January 
1, 2019. This temporary payment covers the cost of the same items and 
services including professional services, training and education, 
monitoring, and remote monitoring services, as defined in section 
1861(iii)(2)(A) and (B) of the Act, related to the administration of 
home infusion drugs. The temporary transitional payment began on 
January 1, 2019 and will end the day before the full implementation of 
the home infusion therapy benefit on January 1, 2021, as required by 
section 5012 of the 21st Century Cures Act. The list of transitional 
home infusion drugs and the payment categories for the temporary 
transitional payment for home infusion therapy services can be

[[Page 34690]]

found in Tables 55 and 56 in the CY 2019 HH PPS proposed rule (83 FR 
32465 and 32466).\209\
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    \209\ https://www.govinfo.gov/content/pkg/FR-2018-07-12/pdf/2018-14443.pdf
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    Section 1834(u)(7)(D)(i) of the Act sets the payment amounts for 
each category equal to the amounts determined under the PFS established 
under section 1848 of the Act for services furnished during the year 
for codes and units for such codes specified without application of 
geographic wage adjustment under section 1848(e) of the Act. That is, 
the payment amounts are based on the PFS rates for the Current 
Procedural Terminology (CPT) codes corresponding to each payment 
category. For eligible home infusion suppliers to bill the temporary 
transitional payments for home infusion therapy services for an 
infusion drug administration calendar day, we created a G-code 
associated with each of the three payment categories. The J-codes for 
eligible home infusion drugs, the G-codes associated with each of the 
three payment categories, and instructions for billing for the 
temporary transitional home infusion therapy payment are found in 
Change Request 10836, ``Temporary Transitional Payment for Home 
Infusion Therapy Services for CYs 2019 and 2020.'' \210\
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    \210\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf.
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    Therefore, in this proposed rule, we are updating the temporary 
transitional payments based on the CPT code payment amounts in the CY 
2020 PFS. At the time of publication of this proposed rule, we do not 
yet have the CY 2020 PFS rates. However, actual payments starting on 
January 1, 2020 will be based on the PFS amounts as specified in 
section 1834(u)(7)(D) of the Act as discussed earlier. We will publish 
these updated rates in the CY 2020 physician fee schedule final 
rule.\211\
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    \211\ https://www.cms.gov/apps/physician-fee-schedule/.
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C. Proposed Home Infusion Therapy Services for CY 2021 and Subsequent 
Years

    As previously described in this proposed rule, upon completion of 
the temporary transitional payments for home infusion therapy services 
at the end of CY 2020, payment for home infusion therapy services under 
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255) would be 
implemented beginning January 1, 2021. However, we are making proposals 
regarding home infusion therapy services for CY 2021 and beyond in the 
CY 2020 HH PPS proposed rule to allow adequate time for eligible home 
infusion therapy suppliers to make any necessary software and business 
process changes for implementation on January 1, 2021.
1. Scope of Benefit and Conditions for Payment
    Section 1861(iii) of the Act establishes certain provisions related 
to home infusion therapy with respect to the requirements that must be 
met for Medicare payment to be made to qualified home infusion therapy 
suppliers. These provisions serve as the basis for determining the 
scope of the home infusion drugs eligible for coverage of home infusion 
therapy services, outlining beneficiary qualifications and plan of care 
requirements, and establishing who can bill for payment under the 
benefit.
a. Home Infusion Drugs
    In the 2019 Home Health Prospective Payment System (HH PPS) 
proposed rule (83 FR 32466) we discussed the relationship between the 
home infusion therapy benefit and the DME benefit. We stated that, as 
there is no separate Medicare Part B DME payment for the professional 
services associated with the administration of certain home infusion 
drugs covered as supplies necessary for the effective use of external 
infusion pumps, we consider the home infusion therapy benefit to be a 
separate payment in addition to the existing payment for the DME 
equipment, accessories, and supplies (including the home infusion drug) 
made under the DME benefit. Consistent with the definition of ``home 
infusion therapy,'' the home infusion therapy payment explicitly and 
separately pays for the professional services related to the 
administration of the drugs identified on the DME LCD for external 
infusion pumps, which are furnished in the individual's home. For 
purposes of the temporary transitional payments for home infusion 
therapy services in CYs 2019 and 2020, the term ``transitional home 
infusion drug'' includes the HCPCS codes for the drugs and biologicals 
covered under the DME LCD for External Infusion Pumps (L33794). 
However, while section 1834(u)(7)(A)(iii) of the Act defines the term 
``transitional home infusion drug,'' section 1834(u)(7)(A)(iii) of the 
Act does not specify the HCPCS codes for home infusion drugs for which 
home infusion therapy services would be covered beginning in CY 2021. 
We received comments on the CY 2019 HH PPS proposed rule requesting 
clarification of the drugs and biologicals identified as ``home 
infusion drugs'' and whether, under the permanent benefit to be 
implemented in 2021, the scope of drugs would expand beyond the drugs 
identified for coverage under the temporary transitional payment. 
Consequently, we stated in the CY 2019 HH PPS final rule (83 FR 56584) 
that we would continue to examine the criteria for ``home infusion 
drugs'' for coverage of home infusion therapy services beginning in 
2021.
    Section 1861(iii)(3)(C) of the Act defines ``home infusion drug'' 
as a parenteral drug or biological administered intravenously, or 
subcutaneously for an administration period of 15 minutes or more, in 
the home of an individual through a pump that is an item of durable 
medical equipment (as defined in section 1861(n) of the Act). Such term 
does not include insulin pump systems or self-administered drugs or 
biologicals on a self-administered drug exclusion list. This definition 
not only specifies that the drug or biological must be administered 
through a pump that is an item of DME, but references the statutory 
definition of DME at 1861(n) of the Act. This means that ``home 
infusion drugs'' are drugs and biologicals administered through a pump 
that is covered under the Medicare Part B DME benefit. Therefore, we 
interpret this statutory reference in section 1861(iii)(3)(C) of the 
Act to mean that Medicare payment for home infusion therapy is for 
services furnished in coordination with the furnishing of the infusion 
drugs and biologicals specified on the DME LCD for External Infusion 
Pumps.\212\
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    \212\ https://med.noridianmedicare.com/ documents/2230703/
7218263/External+Infusion+Pumps+LCD.
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    In order to be covered under the Part B DME benefit, the external 
infusion pump must be classified as an item of DME, the related drug 
must be reasonable and necessary for the treatment of illness or injury 
or to improve the functioning of a malformed body member, an infusion 
pump is necessary to safely administer the drug, and it has to meet all 
other applicable Medicare statutory and regulatory requirements.\213\ 
The DME LCD for External Infusion Pumps (L33794) specifies the 
``reasonable and necessary'' coverage criteria in order to support 
coverage of external infusion pumps for the indications identified on 
the National Coverage Determination (NCD) for Infusion Pumps.\214\ The 
DME

[[Page 34691]]

Medicare Administrative Contractors (MACs) make the determinations for 
which drugs meet this coverage criteria, and in general, update the 
LCDs quarterly or as needed. There are four MACs, covering various 
jurisdictions, that work together to issue the same LCD under their 
contracts. Therefore, we believe that the term ``home infusion drugs'' 
for coverage of home infusion therapy services, refers to the drugs and 
biologicals identified on the DME LCD for External Infusion Pumps 
(L33794). Therefore, we are proposing to carry forward the definition 
of ``home infusion drugs'' as defined for the temporary, transitional 
payment for home infusion therapy services (83 FR 56579). That is, for 
home infusion therapy services furnished on and after January 1, 2021, 
we are proposing that ``home infusion drugs'' are parenteral drugs and 
biologicals administered intravenously, or subcutaneously for an 
administration period of 15 minutes or more, in the home of an 
individual through a pump that is an item of DME covered under the 
Medicare Part B DME benefit.
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    \213\ Local Coverage Determination (LCD): External Infusion 
Pumps (L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD.
    \214\ https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId= 223&ncdver= 
2&DocID=280.14&SearchType=Advanced&bc= IAAAABAAAAAA&.
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    For external infusion pumps, the supplier must instruct 
beneficiaries on the use of Medicare covered items, and maintain proof 
of delivery and beneficiary instruction in accordance with 42 CFR 
424.57(c)(12). The teaching and training for the safe and effective use 
of the external infusion pump is covered and paid for under the DME 
benefit. By contrast, the services covered under the home infusion 
therapy benefit are intended to provide teaching and training on the 
provision of home infusion drugs besides the teaching and training 
covered under the DME benefit, as we described in the CY2019 HH PPS 
proposed rule (83 FR 32467). The teaching and training provided under 
the home infusion therapy benefit is not intended to duplicate teaching 
and training that is already covered under the DME benefit. We are 
soliciting comments on carrying forward the definition of ``home 
infusion drugs'' as described previously to the permanent home infusion 
therapy services benefit beginning on January 1, 2021.
b. Patient Eligibility and Plan of Care Requirements
    Subparagraphs (A) and (B) of section 1861(iii)(1) of the Act set 
forth beneficiary eligibility and plan of care requirements for ``home 
infusion therapy.'' In accordance with section 1861(iii)(1)(A) of the 
Act, the beneficiary must be under the care of an applicable provider, 
defined in section 1861(iii)(3)(A) of the Act as a physician, nurse 
practitioner, or physician assistant. In accordance with section 
1861(iii)(1)(B) of the Act, the beneficiary must also be under a plan 
of care, established by a physician (defined at section 1861(r)(1) of 
the Act), prescribing the type, amount, and duration of infusion 
therapy services that are to be furnished, and periodically reviewed, 
in coordination with the furnishing of home infusion drugs under Part B 
based on these statutory requirements. Section 486.520 sets out the 
standards of care that qualified home infusion therapy suppliers must 
meet in order to participate in Medicare. Section 486.520(a) requires 
that all patients be under the care of an applicable provider, as 
defined at Sec.  486.505. Section 486.520(b) requires that the 
qualified home infusion therapy supplier must ensure that all patients 
have a plan of care established by a physician that prescribes the 
type, amount, and duration of home infusion therapy services that are 
to be furnished. The plan of care must include the specific medication, 
the prescribed dosage and frequency, as well as the professional 
services to be utilized for treatment. In addition, the plan of care 
would specify the individualized care and services necessary to meet 
the patient-specific needs. Section 486.520(c) requires that the 
qualified home infusion therapy supplier must ensure that the patient 
plan of care is periodically reviewed by a physician.
    We are proposing to make a number of revisions to the regulations 
to implement the home infusion therapy services payment system 
beginning with January 1, 2021, as outlined in section VI.D of this 
proposed rule. We propose to add a new 42 CFR part 414, subpart P, to 
implement the home infusion therapy services conditions for payment. In 
accordance with the standards at Sec.  486.520, we are proposing 
conforming regulations text, at Sec.  414.1505, requiring that home 
infusion therapy services be furnished to an eligible beneficiary by, 
or under arrangement with, a qualified home infusion therapy supplier 
that meets the health and safety standards for qualified home infusion 
therapy suppliers at Sec.  486.520(a) through (c). We also propose at 
Sec.  414.1510 that, as a condition for payment, qualified home 
infusion therapy suppliers ensure that a beneficiary meets certain 
eligibility criteria for coverage of services, as well as ensure that 
certain plan of care requirements are met. We propose at Sec.  414.1510 
to require that a beneficiary must be under the care of an applicable 
provider, defined in section 1861(iii)(3)(A) of the Act as a physician, 
nurse practitioner, or physician assistant. Additionally, we propose at 
Sec.  414.1510, to require that a beneficiary must be under a plan of 
care, established by a physician. In accordance with section 
1861(iii)(1)(B) of the Act, a physician is defined at section 
1861(r)(1) of the Act, as a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by the State in which he 
performs such function or action. We propose to require at Sec.  
414.1515, that the plan of care must contain those items listed in 
Sec.  486.520(b). In addition to the type of home infusion therapy 
services to be furnished, the physician's orders for services in the 
plan of care must also specify at what frequency the services will be 
furnished, as well as the healthcare professional that will furnish 
each of the ordered services. We are soliciting comments on the 
proposed conditions for payment, which include patient eligibility and 
plan of care requirements.
c. Qualified Home Infusion Therapy Suppliers and Professional Services
    Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home 
infusion therapy supplier'' as a pharmacy, physician, or other provider 
of services or supplier licensed by the State in which the pharmacy, 
physician, or provider of services or supplier furnishes items or 
services. The qualified home infusion therapy supplier must: Furnish 
infusion therapy to individuals with acute or chronic conditions 
requiring administration of home infusion drugs; ensure the safe and 
effective provision and administration of home infusion therapy on a 7-
day-a-week, 24-hour a-day basis; be accredited by an organization 
designated by the Secretary; and meet such other requirements as the 
Secretary determines appropriate. In accordance with this section of 
the Act, 42 CFR part 486, subpart I, establishes the requirements that 
a qualified home infusion therapy supplier must meet in order to 
participate in the Medicare program. These requirements provide a 
framework for CMS to approve home infusion therapy accreditation 
organizations in order for them to approve Medicare certification of 
qualified home infusion therapy suppliers. Section 488.1010 sets forth 
the requirements that accrediting organizations must meet in order to

[[Page 34692]]

demonstrate that their substantive accreditation requirements are 
sufficient for certification of a Medicare qualified home infusion 
therapy supplier. And finally, Sec.  486.525 sets out the services 
furnished by a qualified home infusion therapy supplier which are: 
Professional services, including nursing services; training and 
education; and remote monitoring and monitoring services. Importantly, 
neither the statute, nor the health and safety standards and 
accreditation requirements require the qualified home infusion therapy 
supplier to furnish the pump, home infusion drug, or related pharmacy 
services. The infusion pump, drug, and other supplies, including the 
services required to furnish these items (that is, the compounding and 
dispensing of the drug) remain covered under the DME benefit.
    In accordance with section 1861(iii)(1) of the Act, the CY 2019 HH 
PPS proposed rule described the professional and nursing services, as 
well as the training, education, and monitoring services included in 
the payment to a qualified home infusion therapy supplier for the 
provision of home infusion drugs (83 FR 32467). We did not specifically 
enumerate a list of ``professional services'' in order to avoid 
limiting services or the involvement of providers of services or 
suppliers that may be necessary in the care of an individual patient. 
However, it is important to note that, under section 1862(a)(1)(A) of 
the Act, no payment can be made for Medicare services under Part B that 
are not reasonable and necessary for the diagnosis or treatment of 
illness or injury or to improve the functioning of a malformed body 
member, unless explicitly authorized by statutes (such as vaccines).
    Payment to a qualified home infusion therapy supplier is for an 
infusion drug administration calendar day in the individual's home, 
which, in accordance with section 1834(u)(7)(E) of the Act, refers to 
payment only for the date on which professional services were furnished 
to administer such drugs to such individual. Ultimately, the qualified 
home infusion therapy supplier is the entity responsible for furnishing 
the necessary services to administer the drug in the home and, as we 
noted in the CY 2019 HH PPS final rule (83 FR 56581), 
``administration'' refers to the process by which the drug is entering 
the patient's body. Therefore, it is necessary for the qualified home 
infusion therapy supplier to be in the patient's home, on occasions 
when the drug is being administered in order to provide an accurate 
assessment to the physician responsible for ordering the home infusion 
drug and services. The services provided would include patient 
evaluation and assessment; training and education of patients and their 
caretakers, assessment of vascular access sites and obtaining any 
necessary bloodwork; and evaluation of medication administration. 
However, visits made solely for the purposes of venipuncture on days 
where there is no administration of the infusion drug would not be 
separately paid because the single payment includes all services for 
administration of the drug. Payment for an infusion drug administration 
calendar day is a bundled payment, which reflects not only the visit 
itself, but any necessary follow-up work (which could include visits 
for venipuncture), or care coordination provided by the qualified home 
infusion therapy supplier. Any care coordination, or visits made for 
venipuncture, provided by the qualified home infusion therapy supplier 
that occurs outside of an infusion drug administration calendar day 
would be included in the payment for the visit (83 FR 56581).
    Additionally, section 1861(iii)(1)(B) of the Act requires that the 
patient be under a plan of care established and periodically reviewed 
by a physician, in coordination with the furnishing of home infusion 
drugs. The physician is responsible for ordering the reasonable and 
necessary services for the safe and effective administration of the 
home infusion drug, as indicated in the patient plan of care. In 
accordance with this section, the physician is responsible for 
coordinating the patient's care in consultation with the DME supplier 
furnishing the home infusion drug. We recognize that collaboration 
between the ordering physician and the DME supplier furnishing the home 
infusion drug is imperative in providing safe and effective home 
infusion. Payment for physician services, including any home infusion 
care coordination services, are separately paid to the physician under 
the PFS and are not covered under the home infusion therapy benefit. 
However, payment under the home infusion therapy benefit to eligible 
home infusion therapy suppliers is for the professional services that 
inform collaboration between physicians and home infusion therapy 
suppliers. Care coordination between the physician and DME supplier, 
although likely to include review of the services indicated in the home 
infusion therapy supplier plan of care, is paid separately from the 
payment under the home infusion therapy benefit.
    The DME Quality Standards require the supplier to review the 
patient's record and consult with the prescribing physician as needed 
to confirm the order and to recommend any necessary changes, 
refinements, or additional evaluations to the prescribed equipment, 
item(s), and/or service(s). Follow-up services to the beneficiary and/
or caregiver(s), must be consistent with the type(s) of equipment, 
item(s) and service(s) provided, and include recommendations from the 
prescribing physician or healthcare team member(s).\215\ Additionally, 
DME suppliers are required to communicate directly with patients 
regarding their medications. As described in Chapter 5 of the Medicare 
Program Integrity Manual: Items and Services Having Special DME Review 
Considerations, section 5.2.8, DME suppliers are required to contact 
the beneficiary prior to dispensing a refill to the original order. 
This is done to ensure that the refilled item remains reasonable and 
necessary, existing supplies are approaching exhaustion, and to confirm 
any changes/modifications to the order.\216\
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    \215\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Downloads/Final-DMEPOS-Quality-Standards-Eff-01-09-2018.pdf.
    \216\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c05.pdf.
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    Additionally, the ordering physician can bill separately for 
physicians' services such as Chronic Care Management (CCM) and Remote 
Patient Monitoring codes under the PFS for care planning and 
coordination of home infusion therapy services. CCM services are 
typically provided outside of face-to-face patient visits, and focus on 
characteristics of advanced primary care such as a continuous 
relationship with a designated member of the care team; patient support 
for chronic diseases to achieve health goals; 24/7 patient access to 
care and health information; receipt of preventive care; patient and 
caregiver engagement; and timely sharing and use of health 
information.\217\ Remote patient monitoring services, including 
telephone evaluation and management services by a physician, or brief 
virtual check-ins, can also be billed under the PFS. In general, when 
communication technology-based services originate from a related 
evaluation and management (E/M) visit provided within the previous 7 
days by the same physician or other qualified health care professional, 
this service is considered bundled into that previous E/M visit and 
would not be separately billable.

[[Page 34693]]

However, physicians can bill separately for remote monitoring services 
after an initial face-to-face visit. Billing for this service requires 
at least 30 minutes of physician time and includes the collection and 
interpretation of data. Beginning January 1, 2019, Medicare now also 
pays separately for set-up, interpretation, and transmission of data 
collected remotely. Additionally, virtual check-in services are 
billable when a physician or other qualified health care professional 
has a brief non-face-to-face check-in with a patient via communication 
technology to assess whether the patient's condition necessitates an 
office visit, and can be billed in cases where the check-in service 
does not lead to an office visit, as there is no office visit with 
which the check-in service can be bundled.\218\
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    \217\ https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/chroniccaremanagement.pdf.
    \218\ https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    In summary, the qualified home infusion therapy supplier is 
responsible for the reasonable and necessary services related to the 
administration of the home infusion drug in the individual's home. 
These services may require some degree of care coordination or 
monitoring outside of an infusion drug administration calendar day; 
however, these services are built into the bundled payment. Care 
coordination furnished by the DME supplier, who is responsible for 
furnishing the equipment and supplies, including the home infusion 
drug, is required and paid for under the DME benefit. Care coordination 
furnished by the physician who establishes the plan of care is 
separately billable under the PFS.
d. Home Infusion Therapy and the Interaction With Home Health
    Because a qualified home infusion therapy supplier is not required 
to become accredited as a Part B DME supplier or to furnish the home 
infusion drug, and because payment is determined by the provision of 
services furnished in the patient's home, we acknowledged in the CY 
2019 HH PPS proposed rule the potential for overlap between the new 
home infusion therapy benefit and the home health benefit (83 FR 
32469). We stated that a beneficiary is not required to be considered 
homebound in order to be eligible for the home infusion therapy 
benefit; however, there may be instances where a beneficiary under a 
home health plan of care also requires home infusion therapy services. 
Additionally, because section 5012 of the 21st Century Cures Act amends 
section 1861(m) of the Act to exclude home infusion therapy from home 
health services effective on January 1, 2021, we stated that a 
beneficiary may utilize both benefits concurrently. We solicited 
feedback on the relationship between the Medicare home health benefit 
and the home infusion therapy benefit, particularly in instances when a 
beneficiary meets eligibility requirements for both.
    In general, commenters stated concern with the ability of qualified 
home infusion therapy suppliers to furnish the professional services 
required under both benefits when care needs overlap. One commenter 
stated that the benefits effectively do not overlap, as ``each benefit 
stands independent from the other and covers different treatment and 
different care.'' Specifically, this commenter stated that home health 
agencies do not own or operate pharmacies, prepare home infusion drugs, 
or provide the care coordination necessary to manage drug infusion. 
Similarly, the commenter stated that home infusion providers are 
neither certified nor authorized to offer the full array of care 
services required of a home health agency.
    We agree that there are unique services and providers involved in 
the delivery of care under both the home health benefit and the home 
infusion therapy benefit. We also recognize that home health agencies 
and DME suppliers have separate requirements for accreditation and 
conditions for payment. Likewise, the requirements for home infusion 
therapy accreditation, set out at 42 CFR part 486, subpart I, are 
unique to qualified home infusion therapy suppliers. For instance, in 
order to furnish the services related to the administration of home 
infusion drugs, a qualified home infusion therapy supplier is not 
required to meet the Medicare Home Health Conditions of Participation 
(CoPs) at 42 CFR part 484, unless such supplier is also a Medicare-
certified home health agency. Additionally, a qualified home infusion 
therapy supplier is not required to meet the requirements under the DME 
Quality and Supplier Standards, unless such supplier is also a 
Medicare-enrolled DME supplier. Therefore, we would not expect a home 
health agency that becomes accredited as a qualified home infusion 
therapy supplier to furnish (or arrange for the furnishing of) the DME, 
supplies (including the home infusion drug), and related services when 
a patient is not under a home health plan of care, nor would it be 
permissible for a DME supplier that becomes accredited as a qualified 
home infusion therapy supplier to furnish home health services under 
the Medicare home health benefit. The home health benefit requires that 
home health agencies arrange for the necessary DME and coordinate home 
infusion services when a patient is under a home health plan of care. 
In accordance with the Home Health CoPs at 42 CFR 484.60, the home 
health agency must assure communication with all physicians involved in 
the plan of care, as well as integrate all orders and services provided 
by all physicians and other healthcare disciplines, such as nursing, 
rehabilitative, and social services.
    Furthermore, because both the home health agency and the qualified 
home infusion therapy supplier furnish services in the individual's 
home, and may potentially be the same entity, it is necessary to 
outline the payment process in instances when a beneficiary is 
utilizing both benefits. We continue to believe that the best process 
for payment for furnishing home infusion therapy services to 
beneficiaries who qualify for both benefits is as outlined in the CY 
2019 HH PPS proposed rule (83 FR 32469). If a patient receiving home 
infusion therapy is also under a home health plan of care, and receives 
a visit that is unrelated to home infusion therapy, then payment for 
the home health visit would be covered by the HH PPS and billed on the 
home health claim. When the home health agency furnishing home health 
services is also the qualified home infusion therapy supplier 
furnishing home infusion services, and a home visit is exclusively for 
the purpose of furnishing items and services related to the 
administration of the home infusion drug, the home health agency would 
submit a home infusion therapy services claim under the home infusion 
therapy benefit. If the home visit includes the provision of other home 
health services in addition to, and separate from, home infusion 
therapy services, the home health agency would submit both a home 
health claim under the HH PPS and a home infusion therapy claim under 
the home infusion therapy benefit. However, the agency must separate 
the time spent furnishing services covered under the HH PPS from the 
time spent furnishing services covered under the home infusion therapy 
benefit. DME continues to be excluded from the consolidated billing 
requirements governing the HH PPS and therefore, the DME services, 
equipment, and supplies (including the drug and related services) will 
continue to be paid for outside of the HH PPS. If the qualified home 
infusion therapy supplier is not the same entity as the home health 
agency furnishing the home health services, the

[[Page 34694]]

home health agency would continue to bill under the HH PPS on the home 
health claim, and the qualified home infusion therapy supplier would 
bill for the services related to the administration of the home 
infusion drugs on the home infusion therapy services claim.
    After publishing the CY 2019 HH PPS final rule with comment period, 
we received correspondence requesting clarification of the relationship 
between the home health benefit and the furnishing of home infusion 
therapy services in CYs 2019 and 2020. Specifically, we received 
questions as to whether an eligible home infusion supplier can furnish 
home infusion therapy services, and bill for the temporary transitional 
payment, to the same patient that is under a home health plan of care, 
where the home health agency is furnishing care unrelated to the home 
infusion therapy, such as wound care and physical therapy. In response, 
we posted a ``Frequently Asked Questions'' (FAQs) document to our home 
infusion therapy web page,\219\ relying on the authority of section 
1834(u)(7)(G) of the Act (as added by section 50401 of the BBA of 
2018), which allows the Secretary to implement the transitional home 
infusion therapy benefit by program instruction or otherwise, 
notwithstanding any other provision of law. In this FAQ, we clarified 
that during the 2-year temporary transitional payment period (CYs 2019 
and 2020), home health services covered under the Medicare home health 
benefit continue to include the in-home services covered under the new 
home infusion therapy benefit. Therefore, if a patient's home health 
plan of care includes home infusion therapy services, the costs of such 
services would be recognized as part of the payment made for the 
patient's specific Home Health Resource Group (HHRG). The clarification 
in the FAQs was not intended to, and does not, make any changes to our 
general policy that, as with any other plan of care service that the 
HHA cannot provide, if a patient under a home health plan of care 
requires in-home skilled services needed for the safe and effective 
administration of a transitional home infusion drug and the home health 
agency determines it does not have the staff available to furnish those 
services as home health services under the home health benefit (and 
cannot provide such services under arrangement), the home health agency 
should not accept the patient on service or continue to provide other 
home health services under an existing plan of care. In accordance with 
the Home Health CoPs at Sec.  484.60 home health agencies can only 
accept patients for treatment on the reasonable expectation that the 
home health agency can meet the patient's medical, nursing, 
rehabilitative, and social needs in his or her place of residence.
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    \219\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
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    We believe the statutory provisions at section 1861(m) of the Act 
do not allow both home health providers and eligible home infusion 
suppliers to furnish and bill for home infusion therapy services to 
beneficiaries under a home health plan of care. Therefore we stated in 
the CY 2019 HH PPS final rule that home infusion therapy was excluded 
from home health services beginning in CY 2019. This was intended to 
convey that payment for the separate, transitional home infusion 
therapy services benefit under section 1834(u)(7) of the Act is 
excluded from home health services. Sections 5012(c)(3) and (d) of the 
Cures Act, read together, clearly indicate that home infusion therapy 
is not excluded from home health services until January 1, 2021. A home 
health agency may subcontract with an eligible home infusion supplier 
in CYs 2019 and 2020 to furnish home infusion therapy services to a 
beneficiary under a home health plan of care; however, such services 
would be considered home health services and should be billed by the 
home health agency under the Medicare home health benefit and not the 
home infusion therapy benefit. In addition, the eligible home infusion 
supplier cannot bill for such services under the home infusion therapy 
benefit as such services are covered as home health services under the 
Medicare home health benefit.
    Therefore, for home infusion therapy services furnished in CYs 2019 
and 2020, if a patient who is considered homebound and is under a 
Medicare home health plan of care, the home health agency should 
continue to furnish the professional services related to the 
administration of transitional home infusion drugs, in accordance with 
the Home Health CoPs and other regulations, as home health services. 
Additionally, the home health agency shall bill for such services as 
home health services under the Medicare home health benefit. Further, 
if an eligible home infusion supplier is under contract with a home 
health agency to provide the necessary home infusion therapy services 
to a patient under a home health plan of care, such services would be 
considered home health services and billed by the home health agency 
under the Medicare home health benefit and not the home infusion 
therapy benefit. Additionally, the eligible home infusion supplier 
under contract with the home health agency cannot bill Medicare for the 
temporary transitional payment but would seek payment from the home 
health agency. This clarification regarding the relationship between 
the home health benefit and the home infusion benefit in CYs 2019 and 
2020 is not intended to limit access to home infusion therapy services 
to those beneficiaries receiving home health services under the 
Medicare home health benefit. Neither the transitional nor the 
permanent home infusion therapy services benefit require that the 
beneficiary be under a home health plan of care. Rather, because 
transitional home infusion therapy services are separately payable 
beginning January 1, 2019, the receipt of home health services is not 
necessary in order for a beneficiary to be eligible to receive home 
infusion therapy services.
2. Solicitation of Public Comments Regarding Notification of Infusion 
Therapy Options Available Prior To Furnishing Home Infusion Therapy 
Services
    Section 1834(u)(6) of the Act requires that prior to the furnishing 
of home infusion therapy to an individual, the physician who 
establishes the plan described in section 1861(iii)(1) of the Act for 
the individual shall provide notification (in a form, manner, and 
frequency determined appropriate by the Secretary) of the options 
available (such as home, physician's office, hospital outpatient 
department) for the furnishing of infusion therapy under this part. We 
recognize there are several possible forms, manners, and frequencies 
that physicians may use to notify patients of their infusion therapy 
options. For example, a physician may verbally discuss the treatment 
options with the patient during the visit and annotate the treatment 
decision in the medical records before establishing the infusion 
therapy plan. Some physicians may also provide options in writing to 
the patient in the hospital discharge papers or office visit summaries, 
as well as retain a written patient attestation that all options were 
provided and considered. Additionally, the frequency of discussing 
these options could vary based on a routine scheduled visit or 
according the individual's clinical needs.
    We are soliciting comments in the CY 2020 PFS proposed rule 
regarding the appropriate form, manner, and frequency that any 
physician must use to provide notification of the treatment

[[Page 34695]]

options available to his/her patient for the furnishing of infusion 
therapy (home or otherwise) under Medicare Part B. We also invite 
comments in this rule on any additional interpretations of this 
notification requirement and whether this requirement is already being 
met under the temporary transitional payment.

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

    Section 1834(u)(1) of the Act provides the authority for the 
development of a payment system for Medicare-covered home infusion 
therapy services. In accordance with section 1834(u)(1)(A)(i) of the 
Act, the Secretary is required to implement a payment system under 
which a single payment is made to a qualified home infusion therapy 
supplier for items and services furnished by a qualified home infusion 
therapy supplier in coordination with the furnishing of home infusion 
drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit of 
single payment under this payment system is for each infusion drug 
administration calendar day in the individual's home, and requires the 
Secretary, as appropriate, to establish single payment amounts for 
different types of infusion therapy, taking into account variation in 
utilization of nursing services by therapy type. Section 
1834(u)(1)(A)(iii) of the Act provides a limitation to the single 
payment amount, requiring that it shall not exceed the amount 
determined under the PFS (under section 1848 of the Act) for infusion 
therapy services furnished in a calendar day if furnished in a 
physician office setting. Furthermore, such single payment shall not 
reflect more than 5 hours of infusion for a particular therapy in a 
calendar day. This permanent payment system would become effective for 
home infusion therapy items and services furnished on or after January 
1, 2021.
    In accordance with section 1834(u)(1)(A)(ii) of the Act, a unit of 
single payment for each infusion drug administration calendar day in 
the individual's home must be established for types of infusion 
therapy, taking into account variation in utilization of nursing 
services by therapy type. Furthermore, section 1834(u)(1)(B)(ii) of the 
Act requires that the payment amount reflect factors such as patient 
acuity and complexity of drug administration. We believe that the best 
way to establish a single payment amount that varies by utilization of 
nursing services and reflects patient acuity and complexity of drug 
administration, is to group home infusion drugs by J-code into payment 
categories reflecting similar therapy types. Therefore, each payment 
category would reflect variations in infusion drug administration 
services.
    Section 1834(u)(7)(C) of the Act established three payment 
categories, with the associated J-code for each transitional home 
infusion drug (see Table 28), for the home infusion therapy services 
temporary transitional payment. Payment category 1 comprises certain 
intravenous infusion drugs for therapy, prophylaxis, or diagnosis, 
including, but not limited to, antifungals and antivirals; inotropic 
and pulmonary hypertension drugs; pain management drugs; and chelation 
drugs. Payment category 2 comprises subcutaneous infusions for therapy 
or prophylaxis, including, but not limited to, certain subcutaneous 
immunotherapy infusions. Payment category 3 comprises intravenous 
chemotherapy infusions, including certain chemotherapy drugs and 
biologicals.
    Maintaining the three current payment categories, with the 
associated J-codes as outlined in section 1834(u)(7)(C) of the Act, 
utilizes an already established framework for assigning a unit of 
single payment (per category), accounting for different therapy types, 
as required by section 1834(u)(1)(A)(ii) of the Act. The payment amount 
for each of these three categories is different, though each category 
has its associated single payment amount. The single payment amount 
(per category) would thereby reflect variations in nursing utilization, 
complexity of drug administration, and patient acuity, as determined by 
the different categories based on therapy type. Retaining the three 
current payment categories would maintain consistency with the already 
established payment methodology and ensure a smooth transition between 
the temporary transitional payments and the permanent payment system to 
be implemented beginning with 2021. Therefore, we propose to carry 
forward the three temporary transitional payment categories for the 
home infusion therapy services payment in CY 2021. Table 28 provides 
the list of J-codes associated with the infusion drugs that fall within 
each of the payment categories. There are several drugs that are paid 
for under the transitional benefit but would not be defined as a home 
infusion drug under the permanent benefit beginning with 2021. As noted 
previously in this proposed rule, section 1861(iii)(3)(C) of the Act 
defines a home infusion drug as a parenteral drug or biological 
administered intravenously or subcutaneously for an administration 
period of 15 minutes or more, in the home of an individual through a 
pump that is an item of DME. Such term does not include the following: 
(1) Insulin pump systems; and (2) a self-administered drug or 
biological on a self-administered drug exclusion list. Hizentra, a 
subcutaneous immunoglobulin, is not included in this definition of home 
infusion drugs because it is listed on a self-administered drug (SAD) 
exclusion list by the MACs. This drug was included as a transitional 
home infusion drug since the definition of such drug in section 
1834(u)(7)(A)(iii) of the Act does not exclude self-administered drugs 
or biologicals on a SAD exclusion list under the temporary transitional 
payment. Therefore, although home infusion therapy services related to 
the administration of Hizentra are covered under the temporary 
transitional payment, because it is on a SAD exclusion list, services 
related to the administration of this biological are not covered under 
the benefit in 2021. Similarly, in accordance with the definition of 
``home infusion drug'' as a parenteral drug or biological administered 
intravenously or subcutaneously, home infusion therapy services related 
to the administration of Ziconotide and Floxuridine are also excluded, 
as these drugs are given via intrathecal and intra-arterial routes 
respectively and therefore do not meet the definition of home infusion 
drug. Subsequent drugs added to the DME LCD for external infusion 
pumps, and compounded infusion drugs not otherwise classified, as 
identified by HCPCS codes J7799 and J7999, will be grouped into the 
appropriate payment category by the DME MACs. Payment category 1 would 
include any subsequent intravenous infusion drug additions, payment 
category 2 would include any subsequent subcutaneous infusion drug 
additions, and payment category 3 would include any subsequent 
intravenous chemotherapy infusion drug additions.

[[Page 34696]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.071

    We are soliciting comments on retaining the three payment 
categories, as identified in Table 28, in CY 2021.
1. Proposed Payment Amounts
    As described previously, section 1834(u)(1)(A)(ii) of the Act 
requires that the payment amount take into account variation in 
utilization of nursing services by therapy type. Additionally, section 
1834(u)(1)(A)(iii) of the Act provides a limitation that the single 
payment shall not exceed the amount determined under the fee schedule 
under section 1848 of the Act for infusion therapy services furnished 
in a calendar day if furnished in a physician office setting, except 
such single payment shall not reflect more than 5 hours of infusion for 
a particular therapy in a calendar day. Finally, section 
1834(u)(1)(B)(ii) of the Act requires the payment amount to reflect 
patient acuity and complexity of drug administration.
    The language at section 1834(u)(1)(A)(ii) of the Act is consistent 
with section 1834(u)(7)(B)(iv) of the Act, which establishes a ``single 
payment amount'' for the temporary transitional payment for an infusion 
drug administration calendar day. Currently, as set out at section 
1834(u)(7)(D) of the Act, each temporary transitional payment category 
is paid at amounts in accordance with six infusion CPT codes and units 
of such codes under the PFS. These payment category amounts are set 
equal to 4 hours of infusion therapy administration services in a 
physician's office for each infusion drug administration calendar day, 
regardless of the length of the visit. We stated in the CY 2019 final 
rule (83 FR 56581) that a ``single payment amount'' means that all home 
infusion therapy services, which include professional services, 
including nursing; training and education; remote monitoring; and 
monitoring, are built into the day on which the services are furnished 
in the home and the drug is being administered. In other words, payment 
for an infusion drug administration

[[Page 34697]]

calendar day is a bundled payment amount per visit. As such, because 
payment for an infusion drug administration calendar day under the 
permanent benefit is also a ``unit of single payment,'' we propose to 
carry forward the payment methodology as outlined in section 
1834(u)(7)(A) of the Act for the temporary transitional payments. We 
propose to pay a single payment amount for each infusion drug 
administration calendar day in the individual's home for drugs assigned 
under each proposed payment category. Each proposed payment category 
amount would be in accordance with the six infusion CPT codes 
identified in section 1834(u)(7)(D) of the Act and as shown in Table 
29. However, because section 1834(u)(1)(A)(iii) of the Act states that 
the single payment shall not exceed more than 5 hours of infusion for a 
particular therapy in a calendar day, we propose that the single 
payment amount be set at an amount equal to 5 hours of infusion therapy 
administration services in a physician's office for each infusion drug 
administration calendar day.
    We believe that proposing a single unit of payment equal to 5 hours 
of infusion therapy services in a physician's office is a reasonable 
approach to account for the bundled services included under the home 
infusion therapy benefit, as described previously. We also understand 
that some patients may require more care coordination or longer visits 
than other patients, and while the physician payments would account for 
varying time spent furnishing care for individual patients (both during 
a visit and outside of a visit) in accordance with the specific PFS 
codes they bill, payment for an infusion drug administration calendar 
day is a unit of single payment and would not vary within each 
category. While the payment amounts do vary between categories to 
account for differences in therapy type, paying the maximum amount 
allowed by statute acknowledges the varying care needs of each 
individual patient within each category. For example, a qualified home 
infusion therapy supplier furnishing care for a patient receiving a 
category 2 infusion drug would receive a single payment amount for each 
infusion drug administration calendar day in the patient's home. 
However, this payment amount would not reflect the varying degrees of 
care among individual patients within each category, or from visit to 
visit for the same patient. And while the payment rates for each of the 
three payment categories is higher than the home health per-visit 
nursing rate, the home infusion therapy rates reflect the increased 
complexity of the professional services provided per category, and as 
required by law.
    Furthermore, furnishing care in the patient's home is fundamentally 
different from furnishing care in the physician's office. Healthcare 
professionals cannot achieve the economies of scale in the home that 
can be achieved in an office setting. As noted previously, the single 
unit of payment for each of the three categories is a bundled payment, 
meaning payment is made on the basis of expected costs for clinically-
defined episodes of care, where some episodes of care for similar 
patients with similar care needs cost more than others. While the 
single unit of payment for the temporary transitional payments was set 
at 4 hours by law, the payment amount for home infusion therapy 
services beginning in CY 2021 cannot exceed 5 hours of infusion for a 
particular therapy. As such, the law provides more latitude for the 
payment of home infusion therapy services beginning in CY 2021. To 
ensure that payment for home infusion therapy adequately covers the 
different patient care needs and level of complexity of services 
provided, we are proposing that the bundled payment amount for home 
infusion therapy services furnished on and after January 1, 2021 should 
be set at the maximum allowed by statute, 5 hours, in order to account 
for these differences and still remain a unit of single payment.
    Setting the payment amounts for each proposed payment category in 
accordance with the CPT infusion code amounts under the PFS accounts 
for variation in utilization of nursing services, patient acuity, and 
complexity of drug administration. CPT codes establish uniformity of 
the services that fall under each code in order to determine the amount 
of payment that a practitioner will receive for such services. Medicare 
PFS valuation of CPT codes uses a combination of the time and 
complexity used to furnish the service, as well as the amount and value 
of resources used. Relative value units (RVUs) are calculated for three 
components used to determine the value of a CPT code. One component, 
the non-facility practice expense RVU, is based, in part, on the amount 
and complexity of services furnished by nursing and ancillary clinical 
staff involved in the procedure or service.\220\ The CPT infusion codes 
under the PFS weight the non-facility practice expense RVUs more 
heavily than the other two components, which include physician work and 
malpractice expense.\221\ Therefore, the values of the CPT infusion 
code amounts, in accordance with the different payment categories, 
reflect variations in nursing utilization, patient acuity, and 
complexity of drug administration, as they are directly proportionate 
to the clinical labor involved in furnishing the infusion services in 
the patient's home.
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    \220\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3096340/.
    \221\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files-Items/RVU19A.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending.

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[[Page 34698]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.072

    The payment methodology outlined previously meets the required 
payment adjustments, while remaining a single unit of payment. However, 
we recognize that often the first visit furnished by a home infusion 
therapy supplier to furnish services in the patient's home may be 
longer or more resource intensive than subsequent visits. In 
particular, patients with new diagnoses may require more disease 
education, instruction on self-monitoring, and support from healthcare 
professionals. Patients who have not been hospitalized may be starting 
home infusion therapy without the benefit of having received any 
training or education prior to discharge. Additionally, considering 
that hospitals often discharge quickly once outside services are in 
place, patients who have started infusion therapy in the hospital, may 
arrive home with central vascular access devices and ambulatory pumps 
without sufficient education or instruction regarding maintenance or 
lifestyle changes. This could potentially lead to safety issues or an 
increase in doctor's office or emergency department visits. Therefore, 
the single payment amount discussed previously may not adequately 
compensate for the first patient visit furnished by the qualified home 
infusion therapy supplier in the patient's home. Section 1834(u)(1)(C) 
of the Act allows the Secretary discretion to adjust the single payment 
amount to reflect outlier situations and other factors as the Secretary 
determines appropriate, in a budget neutral manner. Payment for 
infusion therapy in the physician's office reflects whether a patient 
is new or existing, acknowledging that new patients may initially 
require more time and education. Therefore, we propose increasing the 
payment amounts for each of the three payment categories for the first 
visit by the relative payment for a new patient rate over an existing 
patient rate using the physician evaluation and management (E/M) 
payment amounts for a given year. Overall this adjustment would be 
budget-neutral, in accordance with the requirement at section 
1834(u)(1)(C)(ii) of the Act, resulting in a small decrease to the 
payment amounts for any subsequent visits. This would be similar to the 
LUPA add-on payment under the home health benefit, which is paid for 
the first LUPA episode in a sequence of adjacent episodes or episodes 
that occur as the only episode. It is important to note that the first 
visit payment amount is only issued on the first home visit to initiate 
home infusion therapy services furnished by the qualified home infusion 
therapy supplier. Any changes in the plan of care or drug regimen, 
including the addition of drugs or biologicals that may change the 
payment category, would not trigger a first visit payment amount. If a 
patient receiving home infusion therapy services is discharged, the 
home infusion therapy services claim must show a patient status code to 
indicate a discharge with a gap of more than 60 days in order to bill a 
first visit again if the patient is readmitted. This means that upon 
re-admission, there cannot be a G-code billed for this patient in the 
past 60 days, and the last G-code billed for this patient must show 
that the patient had been discharged. A qualified home infusion therapy 
supplier could bill the first visit payment amount on day 61 for a 
patient who had previously been discharged from service. We also 
recognize that many beneficiaries have been receiving services during 
the temporary transitional payment period, and as a result, many of 
these patients already have a working knowledge of their pump and may 
need less start-up time with the nurse during their initial week of 
visits during the permanent benefit. Therefore, suppliers would not be 
able to bill for the initial visit amount for those patients who have 
been receiving services under the temporary transitional payment, and 
have billed a G-code within the past 60 days. Table 30 shows the E/M 
visit codes and PFS payment amounts for CY 2019, for both new and 
existing patients, used to determine the increased payment amount for 
the first visit. Using the CY 2019 PFS rates, this results in a 60 
percent increase in the first visit payment amount and a 3.76 percent 
decrease in subsequent visit amounts.

[[Page 34699]]

[GRAPHIC] [TIFF OMITTED] TP18JY19.073

    In summary, we propose that the payment amounts per category, for 
an infusion drug administration calendar day under the permanent 
benefit, be in accordance with the six PFS infusion CPT codes and units 
for such codes, as described in section 1834(u)(7)(D) of the Act; 
however, we propose to set the amount equivalent to 5 hours of infusion 
in a physician's office, rather than 4 hours. We also propose 
increasing the payment amounts for each of the three payment categories 
for the first home infusion therapy visit by the qualified home 
infusion therapy supplier in the patient's home by the average 
difference between the PFS amounts for E/M existing patient visits and 
new patient visits for a given year, resulting in a small decrease to 
the payment amounts for the second and subsequent visits, using a 
budget neutrality factor. Table 31 shows the 5 hour payment amounts 
(using CY 2019 rates) reflecting the increased payment for the first 
visit and the decreased payment for all subsequent visits. We plan on 
monitoring home infusion therapy service lengths of visits, both 
initial and subsequent, in order to evaluate whether the data 
substantiates this increase or whether we should re-evaluate whether, 
or how much, to increase the initial visit payment amount. We are 
soliciting comments on the proposed CY 2021 payment amounts per 
category, including the proposed payment equivalent to 5 hours of 
infusion in a physician's office and increasing the payment amounts for 
each of the three categories for the first home infusion therapy visit 
by the average difference between the PFS amounts for E/M existing 
patient visits and new patient visits for a given year.
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    \222\ This represents the average difference between the 
physician E/M payment amounts for new versus established patients: 
(the sum of the initial rates - the sum of the existing rates)/(the 
sum of the existing rates) = 60%.
[GRAPHIC] [TIFF OMITTED] TP18JY19.074


[[Page 34700]]



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

1. Proposed Home Infusion Therapy Geographic Wage Index Adjustment
    Section 1834(u)(1)(B)(i) of the Act requires that the single 
payment amount be adjusted to reflect a geographic wage index and other 
costs that may vary by region. In the 2019 HH PPS proposed rule (83 FR 
32467) we stated that we were considering using the Geographic Practice 
Cost Indices (GPCIs) to account for regional variations in wages and 
adjust the payment for home infusion therapy professional services; 
however, after further analysis and consideration we believe the 
geographic adjustment factor (GAF) may be a more appropriate option to 
adjust home infusion therapy payments based on differences in 
geographic wages.
    The GAF is a weighted composite of each PFS locality's work, 
practice expense (PE), and malpractice (MP) GPCIs and represents the 
combined impact of the three GPCI components. The GAF is calculated by 
multiplying the work, PE and MP GPCIs by the corresponding national 
cost share weight: Work (50.886 percent), PE (44.839 percent), and MP 
(4.295 percent).\223\ The work GPCI reflects the relative costs of 
physician labor by region. The PE GPCI measures the relative cost 
difference in the mix of goods and services comprising practice 
expenses among the PFS localities as compared to the national average 
of these costs. The MP GPCI measures the relative regional cost 
differences in the purchase of professional liability insurance (PLI). 
The GAF is updated at least every 3 years per statute and reflects a 
1.5 work GPCI floor for services furnished in Alaska as well as a 1.0 
PE GPCI floor for services furnished in frontier states (Montana, 
Nevada, North Dakota, South Dakota and Wyoming). The GAF is not 
specific to any of the home infusion drug categories, so the GAF 
payment rate would equal the unadjusted rate multiplied by the GAF for 
each locality level, without a labor share adjustment. As such, based 
on locality, the GAF adjusted payment rate would be calculated using 
the following formula:
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    \223\ GAF = (.50886 x Work GPCI) + (.44839 x PE GPCI) + (.04295 
x MP GPCI)

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RateiGAF = GAF * UnadjRatei

    We would apply the appropriate GAF value to the home infusion 
therapy single payment amount based on the site of service of the 
beneficiary. There are currently 112 total PFS localities, 34 of which 
are statewide areas (that is, only one locality for the entire state). 
There are 10 states with 2 localities, 2 states having 3 localities, 1 
state having 4 localities, and 3 states having 5 or more localities. 
The combined District of Columbia, Maryland, and Virginia suburbs; 
Puerto Rico; and the Virgin Islands are the remaining three localities. 
Beginning in 2017, California's locality structure was modified to 
increase its number of localities from 9, under the previous locality 
structure, to 27 under the new Metropolitan Statistical Area based 
locality structure defined by the Office of Management and Budget 
(OMB).
    The list of GAFs by locality for this proposed rule is available as 
a downloadable file at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
    We considered other alternatives to using the GAF (as discussed in 
section VIII.E) such as the hospital wage index (HWI), the GPCI, and 
using just the practice expense component of the GPCI; however, we are 
proposing to use the GAF to geographically wage adjust home infusion 
therapy for CY 2021 and subsequent years. We believe the GAF is the 
best option for geographic wage adjustment because it is the most 
operationally feasible. Utilizing the GAF would allow adjustments to be 
made while leveraging systems that are already in place. There are 
already mechanisms in place to geographically adjust using the GAF and 
applying this option would require less system changes. The adjustment 
would happen on the PFS and be based on the beneficiary zip code 
submitted on the 837P/CMS-1500 professional and supplier claims form.
    Table 32 shows the 2019 rates for the temporary, transitional 
payment by drug category. Using the 2019 rates for the temporary, 
transitional payments, we estimate what the adjusted payments rates 
would be using the GAF. Table 33 shows the distribution of standardized 
adjusted payment rates for the GAF (sorted by standard deviation). The 
results indicate the distribution of payment rates center around the 
unadjusted payment rates when adjusting using the GAF.
[GRAPHIC] [TIFF OMITTED] TP18JY19.075


[[Page 34701]]


[GRAPHIC] [TIFF OMITTED] TP18JY19.076

    The GAF is further discussed in the CY 2017 PFS final rule (81 FR 
80170). Specific GAF values for each payment locality in past years are 
posted in Addendum D to this proposed rule and can be found at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. 
The final CY 2020 GAF rates will be posted when they become available.
    We are proposing that the application of the geographic wage 
adjustment be budget neutral so there would be no overall cost impact. 
However, this will result in some adjusted payments being higher than 
the average and others being lower. In order to make the application of 
the GAF budget neutral we are going to apply a budget-neutrality 
factor. If the rates were set for 2020 the budget neutrality factor 
would be 0.9985. The budget neutrality factor will be recalculated for 
2021 in next year's rule using 2019 utilization data from the first 
year of the temporary transitional payment period. We welcome comments 
on our proposal to use the GAF to wage adjust the home infusion therapy 
services payment, and commenter's suggestions on whether a factor other 
than the GAF should be used.
2. Consumer Price Index
    Subparagraphs (A) and (B) of section 1834(u)(3) of the Act specify 
annual adjustments to the single payment amount that are required to be 
made beginning January 1, 2022. In accordance with these sections we 
would increase the single payment amount by the percent increase in the 
Consumer Price Index for all urban consumers (CPI-U) for the 12-month 
period ending with June of the preceding year, reduced by the 10-year 
moving average of changes in annual economy-wide private nonfarm 
business multifactor productivity (MFP). Accordingly, this may result 
in a percentage being less than 0.0 for a year, and may result in 
payment being less than such payment rates for the preceding year.

F. Other Optional Payment Adjustments/Prior Authorization for CY 2021 
Home Infusion Therapy Services

1. Prior Authorization
    Section 1834(u)(4) of the Act allows the Secretary discretion, as 
appropriate, to apply prior authorization for home infusion therapy 
services. Generally, prior authorization requires that a decision by a 
health insurer or plan be rendered to confirm health care service, 
treatment plan, prescription drug, or durable medical equipment is 
medically necessary.\224\ Prior authorization helps to ensure that a 
service, such as home infusion therapy, is being provided 
appropriately.
---------------------------------------------------------------------------

    \224\ https://www.healthcare.gov/glossary/preauthorization/.
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    In the 2019 HH PPS proposed rule (83 FR 32469), we solicited 
comments as to whether and how prior authorization could potentially be 
used in home infusion. The majority of commenters were concerned that 
applying prior authorization would risk denying or delaying timely 
access to needed services, as an expeditious transition of care is 
clinically and economically important in home infusion. Another 
commenter stated that a CMS process would be welcome assuming the 
clinical information required is clearly defined, there is a defined 
CMS response time that does not prevent timely clinical care, that the 
process is appropriately limited to higher cost drugs, and once prior 
authorization has been made, retroactive denial for medical necessity 
would not be allowed.
    Ultimately, we do not consider prior authorization to be 
appropriate for the home infusion therapy benefit, at this time, as the 
benefit is contingent on the requirement that a home infusion drug or 
biological be administered through a Medicare Part B covered pump that 
is an item of DME. As discussed in section VI.E. of this proposed rule, 
payment for Medicare home infusion therapy is for services furnished in 
coordination with the furnishing of the infusion drugs and biologicals 
specified on the DME LCD for External Infusion Pumps (L33794), with the 
exception of insulin pump systems or any drugs or biologicals on a 
self-administered drug exclusion list. Therefore, we believe that prior 
authorization for home infusion therapy services is not necessary at 
this time, as services are contingent on the requirements under the DME 
benefit. We will monitor the provision of home infusion therapy 
services and revisit the need for prior authorization if issues arise.
2. Payments for High-Cost Outliers for Home Infusion Therapy Services
    Section 1834(u)(1)(C) of the Act allows for discretionary 
adjustments which may include outlier situations and other factors as 
the Secretary determines appropriate. In the 2019 HH PPS proposed rule 
(83 FR 32467) we requested feedback on situations that may incur an 
outlier payment and potential designs for an outlier payment 
calculation. We received a comment stating that ``it would be premature 
to consider outlier payments for home infusion therapy at the outset of 
the payment system. Given that the scope of covered home infusion 
therapy services is limited, and CMS is required to adjust the payment 
amount for patient acuity and complexity of drug administration, there 
may not be a need for outlier payments.'' We agree with this commenter 
that high cost outlier payments are not necessary at this time. We plan 
to monitor the need for such payments and if necessary address outlier 
situations in future rule making.

G. Billing Procedures for CY 2021 Home Infusion Therapy Services

    In the CY 2019 HH PPS proposed rule we discussed billing procedures 
for home infusion therapy services for CY 2021 and subsequent years (83 
FR 32467). We stated that we were considering processing claims for 
home

[[Page 34702]]

infusion therapy services submitted on a Part B practitioner claim 
through the A/B MACs, rather than the DME MACs, given that ``qualified 
home infusion therapy suppliers'' are not limited to DME suppliers. We 
recognized that, although a qualified home infusion therapy supplier is 
not required to furnish DME equipment and supplies, in order for the 
same supplier to bill for both the home infusion therapy services and 
the DME equipment and supplies (including the drug), the provider or 
supplier would need to be enrolled as both a Part B qualified home 
infusion therapy supplier and as a DME supplier. In these instances, 
the same supplier would need to submit separate claims to both the A/B 
MACs and the DME MACs. We solicited comments on whether it is 
reasonable to require separate claims submissions to both the DME MACs 
and the A/B MACs for processing.
    We received a few comments regarding this billing process, both in 
support of requiring separate claims submissions through the DME MACs 
and the A/B MACs. We continue to believe that, as a qualified home 
infusion therapy supplier is only required to enroll in Medicare as a 
Part B supplier, and is not required to enroll as a DME supplier, it is 
more practicable to process home infusion therapy service claims 
through the A/B MACs and the Multi-Carrier System (MCS) for Medicare 
Part B claims. DME suppliers, also enrolled as qualified home infusion 
therapy suppliers, would continue to submit DME claims through the DME 
MACs; however, they would also be required to submit home infusion 
therapy service claims to the A/B MACs for processing. Therefore, we 
plan to require that the qualified home infusion therapy supplier would 
submit all home infusion therapy service claims on the 837P/CMS-1500 
professional and supplier claims form to the A/B MACs. DME suppliers, 
concurrently enrolled as qualified home infusion therapy suppliers, 
would need to submit one claim for the DME, supplies, and drug on the 
837P/CMS-1500 professional and supplier claims form to the DME MAC and 
a separate 837P/CMS-1500 professional and supplier claims form for the 
professional services to the A/B MAC. Because the home infusion therapy 
services are contingent upon a home infusion drug J-code being billed, 
home infusion therapy suppliers must ensure that the appropriate drug 
associated with the visit is billed with the visit or no more than 30 
days prior to the visit. Additionally, we plan to add the home infusion 
G-codes to the PFS, incorporating the required annual and geographic 
wage adjustments. Home infusion therapy suppliers would include a 
modifier on the appropriate G-code to differentiate the first visit 
from all subsequent visits, as well as a modifier to indicate when a 
patient has been discharged from service. This would be necessary in 
order for the qualified home infusion therapy supplier to bill for the 
first visit payment amount for a patient who had previously received 
home infusion therapy services in order to demonstrate a gap of more 
than 60 days between a discharge and the start of subsequent home 
infusion therapy services. We will issue a Change Request (CR) 
providing more detailed instruction regarding billing and policy 
information for home infusion therapy services, which is expected upon 
release of the CY 2020 final rule.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    In section V. of this proposed rule, we propose changes and updates 
to the HH QRP. We believe that the burden associated with the HH QRP 
proposals is the time and effort associated with data collection and 
reporting. As of February 1, 2019, there are approximately 11,385 HHAs 
reporting quality data to CMS under the HH QRP. For the purposes of 
calculating the costs associated with the collection of information 
requirements, we obtained mean hourly wages for these staff from the 
U.S. Bureau of Labor Statistics' May 2017 National Occupational 
Employment and Wage Estimates (https://www.bls.gov/oes/2017/may/oes_nat.htm). To account for overhead and fringe benefits (100 
percent), we have doubled the hourly wage. These amounts are detailed 
in Table 34.
[GRAPHIC] [TIFF OMITTED] TP18JY19.077

    As discussed in section V.D. of this proposed rule, we are 
proposing to remove the Improvement in Pain Interfering with Activity 
Measure (NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP 
under our measure removal Factor 7: Collection or public reporting of a 
measure leads to negative unintended consequences other than patient 
harm. Additionally, we are proposing to remove OASIS item M1242. 
Removing M1242 will result in a decrease in burden of 0.3 minutes of 
clinical staff time to report data at start of care (SOC), 0.3 minutes 
of clinical staff time to report data at resumption of care (ROC) and 
0.3 minutes of clinical staff time to report data at Discharge.

[[Page 34703]]

    As discussed in section V.E. of this proposed rule, we are 
proposing to adopt two new measures: (1) Transfer of Health Information 
to Provider--Post-Acute Care (PAC); and (2) Transfer of Health 
Information to Patient--Post-Acute Care (PAC), beginning with the CY 
2022 HH QRP. We estimate the data elements for the proposed Transfer of 
Health Information quality measures will take 0.6 minutes of clinical 
staff time to report data at Discharge and 0.3 minutes of clinical 
staff time to report data at Transfer of Care (TOC).
    In section V.G. of this proposed rule, we are proposing to collect 
standardized patient assessment data beginning with the CY 2022 HH QRP. 
We estimate the proposed SPADEs will take 10.05 minutes of clinical 
staff time to report data at SOC, 9.15 minutes of clinical staff time 
to report at ROC, and 11.25 minutes of clinical staff time to report 
data at Discharge.
    We estimate that there would be a net increase in clinician burden 
per OASIS assessment of 9.75 minutes at SOC, 8.85 minutes at ROC, 0.3 
minutes at TOC, and 11.55 minutes at Discharge as a result of all of 
the HH QRP proposals in this proposed rule.
    The OASIS is completed by RNs or PTs, or very occasionally by 
occupational therapists (OT) or speech language pathologists (SLP/ST). 
Data from 2018 show that the SOC/ROC OASIS is completed by RNs 
(approximately 84.5 percent of the time), PTs (approximately 15.2 
percent of the time), and other therapists, including OTs and SLP/STs 
(approximately 0.3 percent of the time). Based on this analysis, we 
estimated a weighted clinician average hourly wage of $72.90, inclusive 
of fringe benefits, using the hourly wage data in Table 34. Individual 
providers determine the staffing resources necessary.
    Table 35 shows the total number of OASIS assessments submitted by 
HHAs in CY 2018 and estimated burden at each time point.
[GRAPHIC] [TIFF OMITTED] TP18JY19.078

    Based on the data in Table 35, for the 11,385 active Medicare-
certified HHAs in February 2019, we estimate the total average increase 
in cost associated with changes to the HH QRP at approximately 
$14,923.00 per HHA annually, or $169,898,354.17 for all HHAs annually. 
This corresponds to an estimated increase in clinician burden 
associated with proposed changes to the HH QRP of approximately 204.7 
hours per HHA annually, or 2,330,567.3 hours for all HHAs annually. 
This estimated increase in burden will be accounted for in the 
information collection under OMB control number 0938-1279.

VIII. Regulatory Impact Analysis

A. Statement of Need

1. Home Health Prospective Payment System (HH PPS)
    Section 1895(b)(1) of the Act requires the Secretary to establish a 
HH PPS for all costs of home health services paid under Medicare. In 
addition, section 1895(b) of the Act requires: (1) The computation of a 
standard prospective payment amount include all costs for home health 
services covered and paid for on a reasonable cost basis and that such 
amounts be initially based on the most recent audited cost report data 
available to the Secretary; (2) the prospective payment amount under 
the HH PPS to be an appropriate unit of service based on the number, 
type, and duration of visits provided within that unit; and (3) the 
standardized prospective payment amount be adjusted to account for the 
effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) 
of the Act addresses the annual update to the standard prospective 
payment amounts by the HH applicable percentage increase. Section 
1895(b)(4) of the Act governs the payment computation. Sections 
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard 
prospective payment amount to be adjusted for case-mix and geographic 
differences in wage levels. Section 1895(b)(4)(B) of the Act requires 
the establishment of appropriate case-mix adjustment factors for 
significant variation in costs among different units of services. 
Lastly, section 1895(b)(4)(C) of the Act requires the establishment of 
wage adjustment factors that reflect the relative level of wages, and 
wage-related costs applicable to home health services furnished in a 
geographic area compared to the applicable national average level.
    Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with 
the authority to implement adjustments to the standard prospective 
payment amount (or amounts) for subsequent years to eliminate the 
effect of changes in aggregate payments during a previous year or years 
that were the result of changes in the coding or classification of 
different units of services that do not reflect real changes in case-
mix. Section 1895(b)(5) of the Act provides the Secretary with the 
option to make changes to the payment amount otherwise paid in the case 
of outliers because of unusual variations in the type or amount of 
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires 
HHAs to submit data for purposes of measuring health care quality, and 
links the quality data submission to the annual applicable percentage 
increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires 
the Secretary to implement a new methodology used to determine rural 
add-on payments for CYs 2019 through 2022.
    Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by 
section

[[Page 34704]]

51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, require 
the Secretary to implement a 30-day unit of service, effective for CY 
2020, and calculate a 30-day payment amount for CY 2020 in a budget 
neutral manner, respectively. In addition, section 1895(b)(4)(B) of the 
Act, as amended by section 51001(a)(3) of the BBA of 2018 requires the 
Secretary to eliminate the use of the number of therapy visits provided 
to determine payment, also effective for CY 2020.
2. HHVBP
    The HHVBP Model applies a payment adjustment based on an HHA's 
performance on quality measures to test the effects on quality and 
expenditures.
3. HH QRP
    Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data 
for purposes of measuring health care quality, and links the quality 
data submission to the annual applicable percentage increase.
4. Home Infusion Therapy
    Section 1834(u)(1) of the Act, as added by section 5012 of the 21st 
Century Cures Act, requires the Secretary to establish a home infusion 
therapy services payment system under Medicare. Under this payment 
system a single payment would be made to a qualified home infusion 
therapy supplier for items and services furnished by a qualified home 
infusion therapy supplier in coordination with the furnishing of home 
infusion drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit 
of single payment is for each infusion drug administration calendar day 
in the individual's home. The Secretary shall, as appropriate, 
establish single payment amounts for types of infusion therapy, 
including to take into account variation in utilization of nursing 
services by therapy type. Section 1834(u)(1)(A)(iii) of the Act 
provides a limitation to the single payment amount, requiring that it 
shall not exceed the amount determined under the Physician Fee Schedule 
(under section 1848 of the Act) for infusion therapy services furnished 
in a calendar day if furnished in a physician office setting, except 
such single payment shall not reflect more than 5 hours of infusion for 
a particular therapy in a calendar day. Section 1834(u)(1)(B)(i) of the 
Act requires that the single payment amount be adjusted by a geographic 
wage index. Finally, section 1834(u)(1)(C) of the Act allows for 
discretionary adjustments which may include outlier payments and other 
factors as deemed appropriate by the Secretary, and are required to be 
made in a budget neutral manner. This payment system would become 
effective for home infusion therapy items and services furnished on or 
after January 1, 2021.
    Section 50401 of the BBA of 2018 amended section 1834(u) of the 
Act, by adding a new paragraph (7) that establishes a home infusion 
therapy temporary transitional payment for eligible home infusion 
therapy suppliers for items and services associated with the furnishing 
of transitional home infusion drugs for CYs 2019 and 2020. Under this 
payment methodology (as described in section VI.B. of this proposed 
rule), the Secretary established three payment categories at amounts 
equal to the amounts determined under the Physician Fee Schedule 
established under section 1848 of the Act. This rule would continue 
this categorization for services furnished during CY 2020 for codes and 
units of such codes, determined without application of the geographic 
adjustment.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. Given that we note the 
follow costs associated with the provisions of this proposed rule:
     A regulatory impact analysis (RIA) must be prepared for 
major rules with economically significant effects ($100 million or more 
in any 1 year). We estimate that this rulemaking is ``economically 
significant'' as measured by the $100 million threshold, and hence also 
a major rule under the Congressional Review Act. Accordingly, we have 
prepared a Regulatory Impact Analysis that to the best of our ability 
presents the costs and benefits of the rulemaking.
    The net transfer impact related to the changes in payments under 
the HH PPS for CY 2020 is estimated to be $250 million (1.3 percent). 
The net transfer impact in CY 2020 related to the change in the unit of 
payment under the proposed PDGM is estimated to be $0 million as 
section 51001(a) of the BBA of 2018 requires such change to be 
implemented in a budget-neutral manner.
     HHVBP--The savings impacts related to the HHVBP Model as a 
whole are estimated at $378 million for CYs 2018 through 2022. We do 
not believe the proposal in this proposed rule would affect the prior 
estimate.
     HH QRP--The cost impact for HHA's related to proposed 
changes to the HH QRP are estimated at $169.9 million.
     Home Infusion Therapy--The CY 2020 cost impact related to 
the routine updates to the temporary transitional payments for home 
infusion therapy in CY 2020 is estimated to be less than $1 million in 
either an increase or a decrease in payments to home infusion therapy 
suppliers, depending on the final payment rates under the physician fee 
schedule for CY 2020. The cost impact in CY 2021 related to the 
implementation of the permanent home infusion therapy benefit is 
estimated to be a $3 million reduction in payments to home infusion 
therapy suppliers (using the CY 2019 physician fee schedule payment 
amounts as the 2020 physician fee schedule amounts were not available 
at the time of rulemaking).

[[Page 34705]]

C. Anticipated Effects

1. HH PPS
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, small entities 
include small businesses, nonprofit organizations, and small 
governmental jurisdictions. Most hospitals and most other providers and 
suppliers are small entities, either by nonprofit status or by having 
revenues of less than $7.5 million to $38.5 million in any one year. 
For the purposes of the RFA, we estimate that almost all HHAs and home 
infusion therapy suppliers are small entities as that term is used in 
the RFA. Individuals and states are not included in the definition of a 
small entity. The economic impact assessment is based on estimated 
Medicare payments (revenues) and HHS's practice in interpreting the RFA 
is to consider effects economically ``significant'' only if greater 
than 5 percent of providers reach a threshold of 3 to 5 percent or more 
of total revenue or total costs. The majority of HHAs' visits are 
Medicare paid visits and therefore the majority of HHAs' revenue 
consists of Medicare payments. Based on our analysis, we conclude that 
the policies proposed in this rule would result in an estimated total 
impact of 3 to 5 percent or more on Medicare revenue for greater than 5 
percent of HHAs and home infusions therapy suppliers. Therefore, the 
Secretary has determined that this HH PPS proposed rule would have a 
significant economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a metropolitan statistical area and has fewer 
than 100 beds. This rule is not applicable to hospitals. Therefore, the 
Secretary has determined this final rule will not have a significant 
economic impact on the operations of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2019, that 
threshold is approximately $150 million. This rule is not anticipated 
to have an effect on State, local, or tribal governments, in the 
aggregate, or on the private sector of $150 million or more.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts State law, or otherwise has federalism 
implications. We have reviewed this proposed rule under these criteria 
of Executive Order 13132, and have determined that it will not impose 
substantial direct costs on state or local governments.
2. HHVBP
    Under the HHVBP Model, the first payment adjustment was applied in 
CY 2018 based on PY 1 (2016) data and the final payment adjustment will 
apply in CY 2022 based on PY 5 (2020) data. In the CY 2016 HH PPS final 
rule, we estimated that the overall impact of the HHVBP Model from CY 
2018 through CY 2022 was a reduction of approximately $380 million (80 
FR 68716). In the CYs 2017, 2018, and 2019 HH PPS final rules, we 
estimated that the overall impact of the HHVBP Model from CY 2018 
through CY 2022 was a reduction of approximately $378 million (81 FR 
76795, 82 FR 51751, and 83 FR 56593, respectively). We do not believe 
the proposal in this proposed rule would affect the prior estimate.
3. Regulatory Review Cost Estimation
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule, we must 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that would review the rule, we assume that the total number of unique 
reviewers of this year's proposed rule would be the similar to the 
number of commenters on last year's proposed rule. We acknowledge that 
this assumption may understate or overstate the costs of reviewing this 
rule. It is possible that not all commenters reviewed this year's rule 
in detail, and it is also possible that some reviewers chose not to 
comment on the proposed rule. For these reasons we believe that the 
number of past commenters would be a fair estimate of the number of 
reviewers of this rule. We welcome any comments on the approach in 
estimating the number of entities which would review this proposed 
rule. We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this proposed rule, 
and therefore for the purposes of our estimate we assume that each 
reviewer reads approximately 50 percent of the rule. We seek comments 
on this assumption. Using the wage information from the BLS for medical 
and health service managers (Code 11-9111), we estimate that the cost 
of reviewing this rule is $109.36 per hour, including overhead and 
fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). Assuming 
an average reading speed of 250 words per minute, we estimate that it 
would take approximately 3.53 hours for the staff to review half of 
this proposed rule, which consists of approximately 105,837 words. For 
each HHA that reviews the rule, the estimated cost is $386.04 (3.53 
hours x $109.36). Therefore, we estimate that the total cost of 
reviewing this proposed rule is $442,015.80 ($386.04 x 1,145 
reviewers). For purposes of this estimate, the number of anticipated 
reviewers in this year's rule is equivalent to the number of commenters 
on the CY 2019 HH PPS proposed rule.

D. Detailed Economic Analysis

1. HH PPS
    This rule proposes updates to Medicare payments under the HH PPS 
for the CY 2020. This rule also implements a change in the case-mix 
adjustment methodology for home health periods of care beginning on and 
after January 1, 2020 and implements the change in the unit of payment 
from 60-day episodes to 30-day periods. These changes are made in a 
budget-neutral manner. The impact analysis of this proposed rule 
presents the estimated expenditure effects of policy changes proposed 
in this rule. We use the latest data and best analysis available, but 
we do not make adjustments for future changes in such variables as 
number of visits or case-mix.
    This analysis incorporates the latest estimates of growth in 
service use and payments under the Medicare HH benefit, based primarily 
on Medicare claims data from 2018. We note that certain events may 
combine to limit the scope or accuracy of our impact analysis, because 
such an analysis is future-oriented and, thus, susceptible to errors 
resulting from other changes in the impact time period assessed. Some 
examples of such possible events are newly-legislated general Medicare 
program funding changes made by the Congress, or changes specifically 
related to HHAs. In addition, changes to the Medicare program may 
continue to be made as a result of the Affordable Care Act, or new 
statutory provisions.

[[Page 34706]]

Although these changes may not be specific to the HH PPS, the nature of 
the Medicare program is such that the changes may interact, and the 
complexity of the interaction of these changes could make it difficult 
to predict accurately the full scope of the impact upon HHAs.
    Table 36 represents how HHA revenues are likely to be affected by 
the policy changes proposed in this rule for CY 2020. For this 
analysis, we used an analytic file with linked CY 2018 OASIS 
assessments and HH claims data for dates of service that ended on or 
before December 31, 2018. The first column of Table 36 classifies HHAs 
according to a number of characteristics including provider type, 
geographic region, and urban and rural locations. The second column 
shows the number of facilities in the impact analysis. The third column 
shows the payment effects of the CY 2020 wage index. The fourth column 
shows the payment effects of the CY 2020 rural add-on payment provision 
in statute. The fifth column shows the effects of the implementation of 
the PDGM case-mix methodology for CY 2020. The sixth column shows the 
payment effects of the CY 2020 home health payment update percentage as 
required by section 53110 of the BBA of 2018. And the last column shows 
the combined effects of all the policies proposed in this rule.
    Overall, it is projected that aggregate payments in CY 2020 would 
increase by 1.3 percent. As illustrated in Table 36, the combined 
effects of all of the changes vary by specific types of providers and 
by location. We note that some individual HHAs within the same group 
may experience different impacts on payments than others due to the 
distributional impact of the CY 2020 wage index, the extent to which 
HHAs are affected by changes in case-mix weights between the current 
153-group case-mix model and the case-mix weights under the 432-group 
PDGM, the percentage of total HH PPS payments that were subject to the 
low-utilization payment adjustment (LUPA) or paid as outlier payments, 
and the degree of Medicare utilization.
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2. HHVBP
    As discussed in section IV. of this proposed rule, for the HHVBP 
Model, we are proposing to publicly report performance data for PY 5 
(CY 2020) of the Model. This proposal would not affect our analysis of 
the distribution of payment adjustments for PY 5 as presented in the CY 
2019 HH PPS final rule. Therefore, we are not providing a detailed 
analysis.
3. HH QRP
    Failure to submit data required under section 1895(b)(3)(B)(v) of 
the Act with respect to a calendar year will result in the reduction of 
the annual home health

[[Page 34708]]

market basket percentage increase otherwise applicable to a HHA for 
that calendar year by 2 percentage points. For the CY 2019 payment 
determination, 1,286 of the 11,444 active Medicare-certified HHAs, or 
approximately 11.2 percent, did not receive the full annual percentage 
increase. Information is not available to determine the precise number 
of HHAs that would not meet the requirements to receive the full annual 
percentage increase for the CY 2020 payment determination.
    As discussed in section V.D. of this proposed rule, we are 
proposing to remove one measure beginning with the CY 2022 HH QRP. The 
measure we are proposing to remove is Improvement in Pain Interfering 
with Activity Measure (NQF #0177). As discussed in section V.E. of this 
proposed rule, we are proposing to add two measures beginning with the 
CY 2022 HH QRP. The two measures we are proposing to adopt are: (1) 
Transfer of Health Information to Provider-Post-Acute Care; and (2) 
Transfer of Health Information to Patient-Post-Acute Care. As discussed 
in section V.G. of this proposed rule, we are also proposing to collect 
standardized patient assessment data beginning with the CY 2022 HH QRP. 
Section VII. of this proposed rule provides a detailed description of 
the net increase in burden associated with these proposed changes. We 
have estimated this associated burden beginning with CY 2021 because 
HHAs will be required to submit data beginning with that calendar year. 
The cost impact related to OASIS item collection as a result of the 
changes to the HH QRP is estimated to be a net increase of 
approximately $169.9 million in annualized cost to HHAs, discounted at 
7 percent relative to year 2016, over a perpetual time horizon 
beginning in CY 2021.
4. Home Infusion Therapy Services Payment
a. Home Infusion Therapy Services Temporary Transitional Payment
    At the time of publication of this proposed rule, the CY 2020 PFS 
payment rates were not available, therefore we are unable to estimate 
whether the impact in CY 2020 would result in an increase or decrease 
in overall payments for home infusion therapy services receiving 
temporary transitional payments. However, we estimate the impact due to 
the updated payment amounts for furnishing home infusion therapy 
services, as determined under the physician fee schedule established 
under section 1848 of the Act, may result in up to a $1 million 
increase/decrease in payments for CY 2020.
b. Home Infusion Therapy Services Payment for CY 2021 and Subsequent 
Years
    The following analysis applies to payment for home infusion therapy 
as set forth in section 1834(u)(1) of the Act, as added by section 5012 
of the 21st Century Cures Act (Pub. L. 114-255), and accordingly, 
describes the preliminary impact for CY 2021 only. We should also note 
that as payment amounts are contingent on the Physician Fee Schedule 
(PFS) rates, this impact analysis will be affected by whether rates 
increase or decrease in CY 2020. At the time of publication these rates 
were not available, therefore we used the CY 2019 PFS payment rates for 
the purpose of this analysis. We used CY 2018 claims data to identify 
beneficiaries with DME claims containing 1 of the 37 HCPCS codes 
identified on the DME LCD for External Infusion Pumps (L33794), 
excluding drugs that are statutorily excluded from coverage under the 
permanent home infusion therapy benefit. These include drugs and 
biologicals listed on self-administered drug exclusion lists and drugs 
administered by routes other than intravenous or subcutaneous infusion. 
Because we do not have complete data for CY 2019 (the first year of the 
temporary transitional payments), we used the visit assumptions 
identified in the CY 2019 HH PPS final rule. We calculated the total 
weeks of care, which is the sum of weeks of care across all 
beneficiaries found in each category (as determined from the 2018 
claims). Weeks of care for categories 1 and 3 are defined as the week 
of the last infusion drug or pump claim minus the week of the first 
infusion drug or pump claim plus one. For category 2, we used the 
median number of weeks of care and assumed 1 visit per month, or 12 
visits per year. And finally, we assumed 2 visits for the initial week 
of care, with 1 visit per week for all subsequent weeks in order to 
estimate the total visits of care per category. For this analysis, we 
did not factor in an increase in beneficiaries receiving home infusion 
therapy services due to switching from physician's offices or 
outpatient centers. Because home infusion therapy services under 
Medicare are contingent on utilization of the DME benefit, we 
anticipate utilization will remain fairly stable and that there would 
be no significant changes in the settings of care where current 
infusion therapy is provided. We will continue to monitor utilization 
to determine if referral patterns change significantly once the 
permanent benefit is implemented in CY 2021. Table 37 reflects the 
estimated wage-adjusted beneficiary impact, representative of a 4-hour 
payment rate, compared to a 5-hour payment rate, excluding statutorily 
excluded drugs and biologicals. Column 3 represents the percent change 
from the estimated CY 2019 payment under the temporary transitional 
payment to the estimated CY 2021 payment after applying the GAF wage 
adjustment. Column 4 represents the percent change from the estimated 
CY 2021 payment after applying the GAF wage adjustment index and the 5 
hour payment rate to the estimated payment after removing the 
statutorily excluded drugs. Column 5 represents the percent change from 
the estimated CY 2021 payment after applying the GAF wage adjustment to 
the estimated CY 2021 payment after applying the 5-hour payment rate 
(prior to removing statutorily excluded drugs and biologicals). 
Overall, we estimate a 4.3 percent decrease ($3 million) in payments to 
home infusion therapy suppliers in CY 2021.
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E. Alternatives Considered

1. HH PPS
    For CY 2020, we did not consider alternatives to changing the unit 
of payment from 60 days to 30 days, eliminating the use of therapy 
thresholds for the case-mix adjustment, and requiring the revised 
payments to be budget neutral as the BBA of 2018 requires these changes 
to be implemented on January 1, 2020. Section 51001 of the BBA of 2018 
requires the change in the unit of payment from 60 days to 30 days to 
be made in a budget neutral manner and mandates the elimination of the 
use of therapy thresholds for case-mix adjustment purposes. The BBA of 
2018 also requires that we make assumptions about behavior changes that 
could occur as a result of the implementation of the 30-day unit of 
payment and as a result of the case-mix adjustment factors that are 
implemented in CY 2020 in calculating a 30-day payment amount for CY 
2020 in a budget neutral manner.
    We did consider alternatives to complete RAP elimination by CY 
2021. Specifically, considered a RAP phase-out over 2 years instead of 
the proposed 1 year (that is, complete elimination of RAPs by CY 2022) 
because we believed that additional time would be needed for HHAs to 
appropriately align their systems with the new policy. However, we 
chose to propose this change in CY 2020 due to imminent program 
integrity concerns that have shown increasing amounts of fraudulent 
activity due to the current RAP policy. We also considered different 
time frames for the submission of the NOA, including a 7 day timeframe 
in which to submit a timely-filed NOA. However, to be consistent with 
similar requirements in other settings (for example, hospice where the 
NOE must be submitted within 5 calendar days), we believe the 5 day 
timely-filing requirement would

[[Page 34710]]

ensure that the Medicare claims processing system is alerted to 
mitigate any overpayments for services that should be covered under the 
home health benefit.
2. HHVBP
    With regard to our proposal to publicly report on the CMS website 
the CY 2020 (PY 5) Total Performance Score (TPS) and the percentile 
ranking of the TPS for each competing HHA that qualifies for a payment 
adjustment in CY 2020, we also considered not making this Model 
performance data public, and whether there was any potential cost to 
stakeholders and beneficiaries if the data were to be misinterpreted. 
However, we believe that providing definitions for the HHVBP TPS and 
the TPS Percentile Ranking methodology would address any such concerns 
by ensuring the public understands the relevance of these data points 
and how they were calculated. We also considered the financial costs 
associated with our proposal to publicly report HHVBP data, but do not 
anticipate such costs to CMS, stakeholders or beneficiaries, as CMS 
already calculates and reports the TPS and TPS Percentile Ranking in 
the Annual Reports to HHAs. As discussed in section IV. of this 
proposed rule, we believe the public reporting of such data would 
further enhance quality reporting under the Model by encouraging 
participating HHAs to provide better quality of care through focusing 
on quality improvement efforts that could potentially improve their 
TPS. In addition, we believe that publicly reporting performance data 
that indicates overall performance may assist beneficiaries, 
physicians, discharge planners, and other referral sources in choosing 
higher-performing HHAs within the nine Model states and allow for more 
meaningful and objective comparisons among HHAs on their level of 
quality relative to their peers.
3. HH QRP
    We believe that removing the Pain Interfering with Activity Measure 
(NQF #0177) from the HH QRP beginning with the CY 2022 HH QRP would 
reduce negative unintended consequences. We are proposing the removal 
of the measure under Meaningful Measures Initiative measure removal 
Factor 7: Collection or public reporting of a measure leads to negative 
unintended consequences other than patient harm. We considered 
alternatives to this measure and no appropriate alternative measure is 
ready at this time. Out of an abundance of caution to potential harm 
from over-prescription of opioid medications inadvertently driven by 
this measure, we have determined that removing the current pain measure 
is the most appropriate proposal.
    The proposed adoption of two transfer of health information process 
measures is vital to satisfying section 1899B(c)(1)(E)(ii) of the Act, 
which requires that the quality measures specified by the Secretary 
include measures with respect to the quality measure domain of 
accurately communicating the existence of and providing for the 
transfer of health information and care preferences of an individual 
when the individual transitions from a PAC provider to another 
applicable setting. We believe adopting these measures best addresses 
the requirements of the IMPACT Act for this domain. We considered not 
adopting these proposals and doing additional analyses for a future 
implementation. This approach was not viewed as a viable alternative 
because of the extensive effort invested in creating the best measures 
possible and failure to adopt measures in the domain of transfer of 
health information puts CMS at risk of not meeting the legislative 
mandate of the IMPACT Act.
    Collecting and reporting standardized patient assessment data under 
the HH QRP is required under section 1899B(b)(1) of the Act. We have 
carefully considered assessment items for each of the categories of 
assessment data and believe these proposals best address the 
requirements of the Act for the HH QRP. The proposed SPADEs are items 
that received additional national testing after they were proposed in 
the CY 2018 HH PPS proposed rule (82 FR 35354 through 35371) and more 
extensively vetted. These items have been carefully considered and the 
alternative of not proposing to adopt standardized patient assessment 
data will result in CMS not meeting our legislative mandate under the 
IMPACT Act.
4. Home Infusion Therapy
a. Home Infusion Therapy Services Temporary Transitional Payment
    We did not consider alternatives to updating the home infusion 
therapy services temporary transitional payment rates for CY 2020 
because section 1834(u)(7)(D) of the Act requires the Secretary to pay 
eligible home infusion suppliers for home infusion therapy services at 
amounts equal to the amounts determined under the physician fee 
schedule for services furnished during the year for codes and units of 
such codes with respect to drugs included in payment categories as 
outlined in section 1834(u)(7)(C) of the Act, determined without 
application of the geographic wage adjustment.
b. Home Infusion Therapy Services Payment for CY 2021 and Subsequent 
Years
    We did not consider alternatives to proposing the home infusion 
therapy services payment system for CY 2021 in the CY 2020 HH PPS 
proposed rule, given that qualified home infusion therapy suppliers 
would need ample time to understand and implement the payment policies 
and billing procedures related to the new payment system.
    For the CY 2020 HH PPS proposed rule, we did consider three 
alternatives to the payment proposals articulated in section VI.D. of 
this proposed rule. We considered proposing a payment methodology that 
maintains the three payment categories and PFS codes; but that pays per 
amount and per unit for the current PFS infusion codes, up to 5 hours, 
meaning we would not set the payment amount to a base amount of 5 hours 
of infusion. We would utilize two existing home infusion codes for 
billing, which would then correspond with the PFS code amounts per 
hour. Suppliers would bill code 99601 (Home infusion/specialty drug 
administration, per visit (up to 2 hours)), which would correspond to 
the first 2 hours of the visit, after which suppliers would bill code 
99602 (Home infusion/specialty drug administration, per visit (up to 2 
hours); each additional hour), up to 3 hours. We would set the minimum 
payment amount equal to 2 hours of infusion in a physician's office; 
however, in analyzing CY 2018 physician office (carrier) claims we 
found that the time required for most infusion services is about an 
hour. Only 25 to 30 percent of the time, physicians billed for 2 hours 
of care and the service almost never extended to exceed 2 hours. 
Nonetheless, we did not propose this option in order to ensure that 
suppliers are paid appropriately for services provided outside of an 
infusion drug administration calendar day, and that patients are 
assured the full scope of services under the home infusion therapy 
services benefit, which includes remote monitoring.
    We also considered proposing to carry forward the payment 
methodology as outlined in section 50401 of the BBA of 2018, using the 
current payment categories and PFS infusion code amounts and units for 
such codes, and setting payment equal to 4 hours of infusion in the 
physician's office. This methodology would be consistent with the 
current payment methodology for the temporary transitional payment, and

[[Page 34711]]

would not require significant changes in billing procedures. 
Additionally, the three payment categories would reflect therapy type 
and complexity of drug administration, as required under section 
1834(u)(1)(B) of the Act. This payment methodology is similar to the 
proposed payment rates; however, setting payment equal to 5 hours of 
infusion in the physician's office is more in alignment with the 
language at section 1834(u)(1)(A)(iii) of the Act, which sets the 
maximum payment amount at 5 hours of infusion for a particular therapy 
in a calendar day for CY 2021, rather than 4 hours.
    And finally, we considered a third alternative which utilizes the 
5-hour payment amount, but without the increased payment for the first 
visit. This option does not recognize the additional time and resources 
spent during the very first home infusion therapy visit. Increasing the 
payment rate for the first visit more adequately compensates for the 
potential increase in visit length as compared to subsequent visits.
    Additionally, we considered an alternative to the proposed required 
geographic wage adjustment articulated in section V1.E. of this 
proposed rule. Specifically, we considered proposing the pre-floor, 
pre-reclassified hospital wage index (HWI) that we currently use to 
wage-adjust payments for both home health and hospice. With the HWI 
geographic areas are defined using the Core Based Statistical Areas 
(CBSA) established by the Office of Management and Budget (OMB). The 
wage index value that is given to a CBSA is the ratio of the area's 
average hourly wage to the national average hourly wage. The payment 
for a given region would be determined by applying the wage index value 
to the labor portion of the single payment amount. Although the HWI is 
used for other home based services, it presents operational challenges 
that would make it difficult to use for geographic wage adjustment for 
home infusion therapy services. These challenges include mapping zip 
codes to the correct CBSA. In order to utilizing the HWI there would 
need to be significant system changes to accommodate this option. We do 
not believe that the benefits of using the HWI outweigh the operational 
complexity of implementing this option. Also, data analysis showed that 
payment rates fluctuate more and payments tend to be lower in rural 
areas when using the HWI. The most negatively affected states using HWI 
are North Dakota, West Virginia, Alabama, Arkansas, and Louisiana.
    In the 2019 proposed home health rule we considered using the 
Geographic Price Cost Index (GPCI) as the method of wage adjustment (83 
FR 32467). The GPCI measures the relative differences in costs of work, 
practice expense and malpractice in 112 localities compared to the 
national average. After further analysis we determined the GPCI was not 
a viable option. GPCI payments are calculated by adjusting the work, 
practice expense and malpractice relative value units included in the 
PFS by the corresponding GPCI. The relative value units are then 
converted into a dollar amount using a conversion factor. The payment 
for home infusion therapy will be a single payment amount, therefore, a 
single index is needed to geographically adjust the payment.
    Finally, we considered using only the practice expense (PE) GPCI to 
geographically adjust the home infusion single payment amount. The PE 
GPCI is designed to measure the relative cost difference in the mix of 
goods and services comprising practice expenses (not including 
malpractice expenses) among the PFS localities compared to the national 
average of these costs. The PE GPCI comprises four component indices 
(employee wages; purchased services; office rent; and equipment, 
supplies, and other miscellaneous expenses). The PE GPCI comprises 
costs that are similar to home infusion costs. However, we believe that 
this is not the best method for geographical wage adjustment for 
several reasons. First, data analysis showed that the PE GPCI is more 
variable than the GAF. Also, using only the PE GPCI excludes services 
furnished in Alaska from the 1.0 PE floor and they would also not 
benefit from the 1.5 work GPCI floor. Finally, the PE GPCI has not been 
used on its own previously for geographic wage adjustment.
    We solicit comments on the alternatives considered for this 
proposed rule.

F. Accounting Statement and Tables

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 38, we have prepared an accounting statement showing 
the classification of the transfers and costs associated with the CY 
2020 HH PPS provisions of this rule. Table 39 shows the burden to HHA's 
for submission of OASIS. Table 40 provides our best estimate of the 
increase in Medicare payments to home infusion therapy suppliers for 
home infusion therapy beginning in CY 2021.
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G. Regulatory Reform Analysis Under E.O. 13771

    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017 and 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' 
This proposed rule, if finalized, is considered an E.O. 13771 
regulatory action. We estimate the rule generates $169.9 million in 
annualized costs in 2016 dollars, discounted at 7 percent relative to 
year 2016 over a perpetual time horizon. Details on the estimated costs 
of this rule can be found in the preceding and subsequent analyses.

H. Conclusion

1. HH PPS for CY 2020
    In conclusion, we estimate that the net impact of the HH PPS 
policies in this rule is an increase of 1.3 percent, or $250 million, 
in Medicare payments to HHAs for CY 2020. The $250 million increase 
reflects the effects of the CY 2020 home health payment update 
percentage of 1.5 percent as required by section 53110 of the BBA of 
2018 ($290 million increase), and a 0.2 percent decrease in CY 2020 
payments due to the rural add-on percentages mandated by the BBA of 
2018 ($40 million decrease).
2. HHVBP
    In conclusion, as noted previously for the HHVBP Model, we are 
proposing to publicly report performance data for PY 5 (CY 2020) of the 
Model. This proposal would not affect our analysis of the distribution 
of payment adjustments for PY 5 as presented in the CY 2019 HH PPS 
final rule.
    We estimate there would be no net impact (to include either a net 
increase or reduction in payments) for this proposed rule in Medicare 
payments to HHAs competing in the HHVBP Model. However, the overall 
economic impact of the HHVBP Model is an estimated $378 million in 
total savings from a reduction in unnecessary hospitalizations and SNF 
usage as a result of greater quality improvements in the home health 
industry over the life of the HHVBP Model.
3. HH QRP
    In conclusion, we estimate that the changes to OASIS item 
collection as a result of the proposed changes to the HH QRP effective 
on January 1, 2021 would result in a net additional annualized cost of 
$169.9 million, discounted at 7 percent relative to year 2016, over a 
perpetual time horizon beginning in CY 2021.
4. Home Infusion Therapy
a. Home Infusion Therapy Services Temporary Transitional Payment for CY 
2020
    In conclusion, we estimate that the net impact of the temporary 
transitional payment to eligible home infusion suppliers for items and 
services associated with the furnishing of transitional home infusion 
drugs may result in up to a $1 million dollar increase/decrease in 
payments for CY 2020 as determined under the physician fee schedule 
established under section 1848 of the Act.
b. Home Infusion Therapy Services Payment for CY 2021
    In conclusion, we estimate that the net impact of the payment for 
home infusion therapy services for CY 2021 is approximately $3 million 
in reduced payments to home infusion therapy suppliers.
    This analysis, together with the remainder of this preamble, 
provides an initial Regulatory Flexibility Analysis.
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the OMB.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 414

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

42 CFR Part 484

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as follows:

PART 409--HOSPITAL INSURANCE BENEFITS

0
1. The authority citation for part 409 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.
0
2. Section 409.43 is amended by revising paragraph (a) to read as 
follows:


Sec.  409.43  Plan of care requirements.

    (a) Contents. An individualized plan of care must be established 
and periodically reviewed by the certifying physician.
    (1) The HHA must be acting upon a physician plan of care that meets 
the requirements of this section for HHA services to be covered.
    (2) For HHA services to be covered, the individualized plan of care 
must specify the services necessary to meet the patient-specific needs 
identified in the comprehensive assessment.
    (3) The plan of care must include the identification of the 
responsible discipline(s) and the frequency and duration of all visits 
as well as those items listed in Sec.  484.60(a) of this chapter that 
establish the need for such services. All care provided must be in 
accordance with the plan of care.
* * * * *
0
3. Section 409.44 is amended by revising paragraph (c)(2)(iii)(C) to 
read as follows:


Sec.  409.44  Skilled services requirements.

* * * * *
    (c) * * *
    (2) * * *
    (iii) * * *
    (C) The unique clinical condition of a patient may require the 
specialized skills of a qualified therapist or therapist assistant to 
perform a safe and effective maintenance program required in connection 
with the patient's specific illness or injury. Where the clinical 
condition of the patient is such that the

[[Page 34713]]

complexity of the therapy services required--
    (1) Involve the use of complex and sophisticated therapy procedures 
to be delivered by the therapist or the physical therapist assistant in 
order to maintain function or to prevent or slow further deterioration 
of function; or
    (2) To maintain function or to prevent or slow further 
deterioration of function must be delivered by the therapist or the 
physical therapist assistant in order to ensure the patient's safety 
and to provide an effective maintenance program, then those reasonable 
and necessary services must be covered.
* * * * *

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

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

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
0
 5. Add subpart P to read as follows:
Subpart P--Home Infusion Therapy Services Payment

Conditions for Payment

Sec.
414.1500 Basis, purpose, and scope.
414.1505 Requirement for payment.
414.1510 Beneficiary qualifications for coverage of services.
414.1515 Plan of care requirements.

Payment System

414.1550 Basis of payment.

Subpart P--Home Infusion Therapy Services Payment

Conditions for Payment


Sec.  414.1500  Basis, purpose, and scope.

    This subpart implements section 1861(iii) of the Act with respect 
to the requirements that must be met for Medicare payment to be made 
for home infusion services furnished to eligible beneficiaries.


Sec.  414.1505  Requirement for payment.

    In order for home infusion therapy services to qualify for payment 
under the Medicare program the services must be furnished to an 
eligible beneficiary by, or under arrangements with, a qualified home 
infusion therapy supplier that meets following:
    (a) The health and safety standards for qualified home infusion 
therapy suppliers at Sec.  486.520(a) through (c) of this chapter.
    (b) All requirements set forth in Sec. Sec.  414.1510 through 
414.1550.


Sec.  414.1510  Beneficiary qualifications for coverage of services.

    To qualify for Medicare coverage of home infusion therapy services, 
a beneficiary must meet each of the following requirements:
    (a) Under the care of an applicable provider. The beneficiary must 
be under the care of an applicable provider, as defined in section 
1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or 
physician assistant.
    (b) Under a physician plan of care. The beneficiary must be under a 
plan of care that meets the requirements for plans of care specified in 
Sec.  414.1515.


Sec.  414.1515  Plan of care requirements.

    (a) Contents. The plan of care must contain those items listed in 
Sec.  486.520(b) of this chapter that specify the standards relating to 
a plan of care that a qualified home infusion therapy supplier must 
meet in order to participate in the Medicare program.
    (b) Physician's orders. The physician's orders for services in the 
plan of care must specify at what frequency the services will be 
furnished, as well as the discipline that will furnish the ordered 
professional services. Orders for care may indicate a specific range in 
frequency of visits to ensure that the most appropriate level of 
services is furnished.
    (c) Plan of care signature requirements. The plan of care must be 
signed and dated by the ordering physician prior to submitting a claim 
for payment. The ordering physician must sign and date the plan of care 
upon any changes to the plan of care.

Payment System


Sec.  414.1550  Basis of payment.

    (a) General rule. For home infusion therapy services furnished on 
or after January 1, 2021, Medicare payment is made on the basis of 80 
percent of the lesser of the following:
    (1) The actual charge for the item.
    (2) The fee schedule amount for the item, as determined in 
accordance with the provisions of this section.
    (b) Unit of single payment. A unit of single payment is made for 
items and services furnished by a qualified home infusion therapy 
supplier per payment category for each infusion drug administration 
calendar day, as defined at Sec.  486.505 of this chapter.
    (c) Initial establishment of the payment amounts. In calculating 
the initial single payment amounts for CY 2021, CMS determined such 
amounts using the equivalent to 5 hours of infusion services in a 
physician's office as determined by codes and units of such codes under 
the annual fee schedule issued under section 1848 of the Act as 
follows:
    (1) Category 1. Includes certain intravenous infusion drugs for 
therapy, prophylaxis, or diagnosis, including antifungals and 
antivirals; inotropic and pulmonary hypertension drugs; pain management 
drugs; chelation drugs; and other intravenous drugs as added to the 
durable medical equipment local coverage determination (DME LCD) for 
external infusion pumps. Payment equals 1 unit of 96365 plus 4 units of 
96366.
    (2) Category 2. Includes certain subcutaneous infusion drugs for 
therapy or prophylaxis, including certain subcutaneous immunotherapy 
infusions. Payment equals 1 unit of 96369 plus 4 units of 96370.
    (3) Category 3. (i) Includes intravenous chemotherapy infusions, 
including certain chemotherapy drugs and biologicals.
    (ii) Payment equals 1 unit of 96413 plus 4 units of 96415.
    (4) Initial visit. (i) For each of the three categories listed in 
paragraphs (c)(1) through (3) of this section, the payment amounts are 
set higher for the first visit by the qualified home infusion therapy 
supplier to initiate the furnishing of home infusion therapy services 
in the patient's home and lower for subsequent visits in the patient's 
home. The difference in payment amounts is a percentage based on the 
relative payment for a new patient rate over an existing patient rate 
using the annual physician fee schedule evaluation and management 
payment amounts for a given year and calculated in a budget neutral 
manner.
    (ii) The first visit payment amount is subject to the following 
requirements if a patient has previously received home infusion therapy 
services:
    (A) The previous home infusion therapy services claim must include 
a patient status code to indicate a discharge.
    (B) If a patient has a previous claim for HIT services, the first 
visit home infusion therapy services claim subsequent to the previous 
claim must show a gap of more than 60 days between the last home 
infusion therapy services claim and must indicate a discharge in the 
previous period before a HIT supplier may submit a home infusion 
therapy services claim for the first visit payment amount.
    (d) Required payment adjustments. The single payment amount 
represents payment in full for all costs associated with the furnishing 
of home infusion therapy services and is subject to the following 
adjustments:

[[Page 34714]]

    (1) An adjustment for a geographic wage index and other costs that 
may vary by region, using an appropriate wage index based on the site 
of service of the beneficiary.
    (2) Beginning in 2022, an annual increase in the single payment 
amounts from the prior year by the percentage increase in the Consumer 
Price Index (CPI) for all urban consumers (United States city average) 
for the 12-month period ending with June of the preceding year.
    (3)(i) An annual reduction in the percentage increase described in 
paragraph (c)(2) of this section by the productivity adjustment 
described in section 1886(b)(3)(B)(xi)(II) of the Act.
    (ii) The application of the paragraph (c)(3)(i) of this section may 
result in both of the following:
    (A) A percentage being less than zero for a year.
    (B) Payment being less than the payment rates for the preceding 
year.
    (e) Medical review. All payments under this system may be subject 
to a medical review adjustment reflecting the following:
    (1) Beneficiary eligibility.
    (2) Plan of care requirements.
    (3) Medical necessity determinations.

PART 484--HOME HEALTH SERVICES

0
6. The authority citation for part 484 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh unless otherwise indicated.

0
7. Section 484.202 is amended by adding the definitions of ``HHCAHPS'' 
and ``HH QRP'' in alphabetical order to read as follows:


Sec.  484.202  Definitions.

* * * * *
    HHCAHPS stands for Home Health Care Consumer Assessment of 
Healthcare Providers and Systems.
    HH QRP stands for Home Health Quality Reporting Program.
* * * * *
0
8. Section 484.205 is amended by--
0
a. Revising paragraph (g)(2)(i);
0
b. Removing paragraph (g)(2)(ii);
0
c. Redesignating paragraph (g)(2)(iii) as paragraph (g)(2)(ii);
0
d. Revising newly resdesignated paragraph (g)(2)(ii);
0
e. Adding paragraph (g)(3);
0
f. Revising the heading for paragraph (h); and
0
g. Adding paragraph (i).
    The revisions and additions read as follows:


Sec.  484.205  Basis of payment.

* * * * *
    (g) * * *
    (2) * * *
    (i) HHAs certified for participation in Medicare on or before 
December 31, 2018. (A) The initial payment for all 30-day periods is 
paid to an HHA at 20 percent of the case-mix and wage-adjusted 30-day 
payment rate.
    (B) The residual final payment for all 30-day periods is paid at 80 
percent of the case-mix and wage-adjusted 30-day payment rate.
    (ii) HHAs certified for participation in Medicare on or after 
January 1, 2019. An HHA that is certified for participation in Medicare 
effective on or after January 1, 2019 receives a single payment for a 
30-day period of care after the final claim is submitted.
    (3) Payments for periods beginning on or after January 1, 2021. 
HHAs receive a single payment for a 30-day period of care after the 
final claim is submitted.
    (h) Requests for anticipated payment (RAP) prior to January 1, 
2021. * * *
    (i) Submission of Notice of Admission (NOA)--(1) For periods of 
care on and after January 1, 2021. For periods of care beginning on and 
after January 1, 2021, all HHAs must submit a Notice of Admission (NOA) 
when either of the following conditions are met:
    (i)(A) The plan of care has been signed by the certifying 
physician.
    (B) If the physician-signed plan of care is not available at the 
time of submission of the NOA, then the submission must be based on 
either of the following:
    (1) A physician's verbal order that--
    (i) Is recorded in the plan of care;
    (ii) Includes a description of the patient's condition and the 
services to be provided by the home health agency;
    (iii) Includes an attestation (relating to the physician's orders 
and the date received) signed and dated by the registered nurse or 
qualified therapist (as defined in Sec.  484.115) responsible for 
furnishing or supervising the ordered service in the plan of care; and
    (iv) Is copied into the plan of care and the plan of care is 
immediately submitted to the physician.
    (2) A referral prescribing detailed orders for the services to be 
rendered that is signed and dated by a physician.
    (ii) [Reserved]
    (2) Consequences of failure to submit a timely Notice of Admission. 
When a home health agency does not file the required NOA for its 
Medicare patients within 5 calendar days after the start of care--
    (i) Medicare does not pay for those days of home health services 
from the start date to the date of filing of the notice of admission;
    (ii) The wage-adjusted 30-day period payment amount is reduced by 
1/30th for each day from the home health start of care date until the 
date the HHA submits the NOA;
    (iii) No LUPA payments are made that fall within the late NOA 
period;
    (iv) The payment reduction cannot exceed the total payment of the 
claim.
    (v)(A) The non-covered days are a provider liability; and
    (B) The provider must not bill the beneficiary for the noncovered 
days.
    (3) Exception to the consequences for filing the NOA late. (i) CMS 
may waive the consequences of failure to submit a timely-filed NOA 
specified in paragraph (i)(2) of this section.
    (ii) CMS determines if a circumstance encountered by a home health 
agency is exceptional and qualifies for waiver of the consequence 
specified in paragraph (i)(2) of this section.
    (iii) A home health agency must fully document and furnish any 
requested documentation to CMS for a determination of exception. An 
exceptional circumstance may be due to, but is not limited to the 
following:
    (A) Fires, floods, earthquakes, or similar unusual events that 
inflict extensive damage to the home health agency's ability to 
operate.
    (B) A CMS or Medicare contractor systems issue that is beyond the 
control of the home health agency.
    (C) A newly Medicare-certified home health agency that is notified 
of that certification after the Medicare certification date, or which 
is awaiting its user ID from its Medicare contractor.
    (D) Other situations determined by CMS to be beyond the control of 
the home health agency.


Sec.  484.225  [Amended]

0
9. Section 484.225 is amended by--
0
a. Removing paragraph (b).
0
b. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
0
c. In newly redesignated paragraph (c), removing the phrase 
``paragraphs (a) through (c) of this section'' and adding in its place 
the phrase ``paragraphs (a) and (b) of this section''.
0
10. Add Sec.  484.245 to read as follows:


Sec.  484.245  Requirements under the Home Health Quality Reporting 
Program (HH QRP).

    (a) Participation. Beginning January 1, 2007, an HHA must report 
Home Health Quality Reporting Program (HH QRP) data in accordance with 
the requirements of this section.
    (b) Data submission. (1) Except as provided in paragraph (d) of 
this section, and for a program year, a HHA must submit all of the 
following to CMS:
    (i) Data on measures specified under sections 1899B(c)(1) and 
1899B(d)(1) of the Act.

[[Page 34715]]

    (ii) Standardized patient assessment data required under section 
1899B(b)(1) of the Act.
    (iii) Quality data required under section 1895(b)(3)(B)(v)(II) of 
the Act, including HHCAHPS survey data. For purposes of HHCAHPS survey 
data submission, the following additional requirements apply:
    (A) Patient count. An HHA that has less than 60 eligible unique 
HHCAHPS patients must annually submit their total HHCAHPS patient count 
to CMS to be exempt from the HHCAHPS reporting requirements for a 
calendar year.
    (B) Survey requirements. An HHA must contract with an approved, 
independent HHCAHPS survey vendor to administer the HHCAHPS on its 
behalf.
    (C) CMS approval. CMS approves an HHCAHPS survey vendor if the 
applicant has been in business for a minimum of 3 years and has 
conducted surveys of individuals and samples for at least 2 years.
    (1) For HHCAHPS, a ``survey of individuals'' is defined as the 
collection of data from at least 600 individuals selected by 
statistical sampling methods and the data collected are used for 
statistical purposes.
    (2) All applicants that meet these requirements will be approved by 
CMS.
    (D) Disapproval by CMS. No organization, firm, or business that 
owns, operates, or provides staffing for a HHA is permitted to 
administer its own HHCAHPS survey or administer the survey on behalf of 
any other HHA in the capacity as an HHCAHPS survey vendor. Such 
organizations will not be approved by CMS as HHCAHPS survey vendors.
    (E) Compliance with oversight activities. Approved HHCAHPS survey 
vendors must fully comply with all HHCAHPS oversight activities, 
including allowing CMS and its HHCAHPS program team to perform site 
visits at the vendors' company locations.
    (2) The data submitted under paragraphs (b)(1)(i) through (iii) of 
this section must be submitted in the form and manner, and at a time, 
specified by CMS.
    (c) Exceptions and extension requirements. (1) A HHA may request 
and CMS may grant exceptions or extensions to the reporting 
requirements under paragraph (b) of this section for one or more 
quarters, when there are certain extraordinary circumstances beyond the 
control of the HHA.
    (2) A HHA may request an exception or extension within 90 days of 
the date that the extraordinary circumstances occurred by sending an 
email to CMS Home Health Annual Payment Update (HHAPU) reconsiderations 
at [email protected] that contains all of the following 
information:
    (i) HHA CMS Certification Number (CCN).
    (ii) HHAs Business Name.
    (iii) HHA Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, title, telephone number, email address, and mailing address (the 
address must be a physical address, not a post office box).
    (v) HHA's reason for requesting the exception or extension.
    (vi) Evidence of the impact of extraordinary circumstances, 
including, but not limited to, photographs, newspaper, and other media 
articles.
    (vii) Date when the HHA believes it will be able to again submit 
data under paragraph (b) of this section and a justification for the 
proposed date.
    (3) Except as provided in paragraph (c)(4) of this section, CMS 
does not consider an exception or extension request unless the HHA 
requesting such exception or extension has complied fully with the 
requirements in this paragraph (c).
    (4) CMS may grant exceptions or extensions to HHAs without a 
request if it determines that one or more of the following has 
occurred:
    (i) An extraordinary circumstance, such as an act of nature, 
affects an entire region or locale.
    (ii) A systemic problem with one of CMS's data collection systems 
directly affects the ability of a HHA to submit data under paragraph 
(b) of this section.
    (d) Reconsiderations. (1)(i) HHAs that do not meet the quality 
reporting requirements under this section for a program year will 
receive a letter of noncompliance via the United States Postal Service 
and notification in the Certification and Survey Provider Enhanced 
Report (CASPER) system.
    (ii) An HHA may request reconsideration no later than 30 calendar 
days after the date identified on the letter of non-compliance.
    (2) Reconsideration requests may be submitted to CMS by sending an 
email to CMS HHAPU reconsiderations at 
[email protected] containing all of the following 
information:
    (i) HHA CCN.
    (ii) HHA Business Name.
    (iii) HHA Business Address.
    (iv) CEO or CEO-designated personnel contact information including 
name, title, telephone number, email address, and mailing address (the 
address must be a physical address, not a post office box).
    (v) CMS identified reason(s) for non-compliance from the non-
compliance letter.
    (vi) Reason(s) for requesting reconsideration, including all 
supporting documentation.
    (3) CMS will not consider a reconsideration request unless the HHA 
has complied fully with the submission requirements in paragraph (d)(2) 
of this section.
    (4) CMS will make a decision on the request for reconsideration and 
provide notice of the decision to the HHA through CASPER and via letter 
sent via the United States Postal Service.
    (e) Appeals. An HHA that is dissatisfied with CMS' decision on a 
request for reconsideration submitted under paragraph (d) of this 
section may file an appeal with the Provider Reimbursement Review Board 
(PRRB) under 42 CFR part 405, subpart R.
0
11. Section 484.250 is revised to read as follows:


Sec.  484.250  OASIS data.

    An HHA must submit to CMS the OASIS data described at Sec.  
484.55(b) and (d) as is necessary for CMS to administer the payment 
rate methodologies described in Sec. Sec.  484.215, 484.220, 484.230, 
484.235, and 484.240.
0
12. Section 484.315 is amended by revising the section heading and 
adding paragraph (d) to read as follows:


Sec.  484.315  Data reporting for measures and evaluation and the 
public reporting of model data under the Home Health Value-Based 
Purchasing (HHVBP) Model.

* * * * *
    (d) For performance year 5, CMS publicly reports the following for 
each competing home health agency on the CMS website:
    (1) The Total Performance Score.
    (2) The percentile ranking of the Total Performance Score.

    Dated: June 14, 2019.
Seema Verma,
 Administrator, Centers for Medicare and Medicaid Services.

    Dated: June 20, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-14913 Filed 7-11-19; 4:15 pm]
BILLING CODE 4120-01-P