[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Rules and Regulations]
[Pages 56406-56638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24145]



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Vol. 83

Tuesday,

No. 219

November 13, 2018

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 409, 424, 484, et al.





Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment 
System Rate Update and CY 2020 Case-Mix Adjustment Methodology 
Refinements; Home Health Value-Based Purchasing Model; Home Health 
Quality Reporting Requirements; Home Infusion Therapy Requirements; and 
Training Requirements for Surveyors of National Accrediting 
Organizations; Final Rule

  Federal Register / Vol. 83 , No. 219 / Tuesday, November 13, 2018 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 424, 484, 486, and 488

[CMS-1689-FC]
RIN 0938-AT29


Medicare and Medicaid Programs; CY 2019 Home Health Prospective 
Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology 
Refinements; Home Health Value-Based Purchasing Model; Home Health 
Quality Reporting Requirements; Home Infusion Therapy Requirements; and 
Training Requirements for Surveyors of National Accrediting 
Organizations

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

ACTION: Final rule with comment period.

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SUMMARY: This final rule with comment period updates the home health 
prospective payment system (HH PPS) payment rates, including the 
national, standardized 60-day episode payment rates, the national per-
visit rates, and the non-routine medical supply (NRS) conversion 
factor, effective for home health episodes of care ending on or after 
January 1, 2019. This rule also: Updates the HH PPS case-mix weights 
for calendar year (CY) 2019 using the most current, complete data 
available at the time of rulemaking; discusses our efforts to monitor 
the potential impacts of the rebasing adjustments that were implemented 
in CYs 2014 through 2017; finalizes a rebasing of the HH market basket 
(which includes a decrease in the labor-related share); finalizes the 
methodology used to determine rural add-on payments for CYs 2019 
through 2022, as required by section 50208 of the Bipartisan Budget Act 
of 2018 (Pub. L. 115-123) hereinafter referred to as the ``BBA of 
2018''; finalizes regulations text changes regarding certifying and 
recertifying patient eligibility for Medicare home health services; and 
finalizes the definition of ``remote patient monitoring'' and the 
recognition of the costs associated with it as allowable administrative 
costs.
    This rule also summarizes the case-mix methodology refinements for 
home health services beginning on or after January 1, 2020, which 
includes the elimination of therapy thresholds for payment and a change 
in the unit of payment from a 60-day episode to a 30-day period, as 
mandated by section 51001 of the Bipartisan Budget Act of 2018. This 
rule also finalizes changes to the Home Health Value-Based Purchasing 
(HHVBP) Model. In addition, with respect to the Home Health Quality 
Reporting Program, this rule discusses the Meaningful Measures 
Initiative; finalizes the removal of seven measures to further the 
priorities of this initiative; discusses social risk factors and 
provides an update on implementation efforts for certain provisions of 
the IMPACT Act; and finalizes a regulatory text change regarding OASIS 
data.
    For the home infusion therapy benefit, this rule finalizes health 
and safety standards that home infusion therapy suppliers must meet; 
finalizes an approval and oversight process for accrediting 
organizations (AOs) that accredit home infusion therapy suppliers; 
finalizes the implementation of temporary transitional payments for 
home infusion therapy services for CYs 2019 and 2020; and responds to 
the comments received regarding payment for home infusion therapy 
services for CY 2021 and subsequent years.
    Lastly, in this rule, we are finalizing only one of the two new 
requirements we proposed to implement in the regulations for the 
oversight of AOs that accredit Medicare-certified providers and 
suppliers. More specifically, for reasons set out more fully in the 
section X. of this final rule with comment period, we have decided not 
to finalize our proposal to require that all surveyors for AOs that 
accredit Medicare-certified providers and suppliers take the same 
relevant and program-specific CMS online surveyor training that the 
State Agency surveyors are required to take.
    However, we are finalizing our proposal to require that each AO 
must provide a written statement with their application to CMS, stating 
that if one of its fully accredited providers or suppliers, in good-
standing, provides written notification that they wish to voluntarily 
withdraw from the AO's CMS-approved accreditation program, the AO must 
continue the provider or supplier's current accreditation until the 
effective date of withdrawal identified by the facility or the 
expiration date of the term of accreditation, whichever comes first.

DATES: 
    Effective Date: This final rule with comment period is effective on 
January 1, 2019.
    Implementation Date: The Patient-Driven Groupings Model (PDGM) 
case-mix methodology refinements and the change in the unit of payment 
from 60-day episodes of care to 30-day periods of care will be for home 
health services (30-day periods of care) beginning on or after January 
1, 2020.
    Comment Date: To be assured consideration, comments on the 
definition of ``infusion drug administration calendar day'' at Sec.  
486.505 and discussed in section VI.D. of this final rule with comment 
period must be received at one of the addresses provided below, no 
later than 5 p.m. on December 31, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1689-FC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1689-FC, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1689-FC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 
[Note: This zipcode for express mail or courier delivery only. This 
zipcode specifies the agency's physical location.]
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    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) contact: Joan Proctor, (410) 786-0949.

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    For information about home infusion therapy health and safety 
standards, contact: CAPT Jacqueline Leach, (410) 786-4282 or Sonia 
Swancy, (410) 786-8445.
    For information about health infusion therapy accreditation and 
oversight, contact: Caroline Gallaher (410) 786-8705.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://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, Transfers, and Benefits
    D. Improving Patient Outcomes and Reducing Burden Through 
Meaningful Measures
II. Background
    A. Statutory Background
    B. Current System for Payment of Home Health Services
    C. Updates to the Home Health Prospective Payment System
    D. Advancing Health Information Exchange
III. Payment Under the Home Health Prospective Payment System (HH 
PPS)
    A. Monitoring for Potential Impacts--Affordable Care Act 
Rebasing Adjustments
    B. CY 2019 HH PPS Case-Mix Weights
    C. CY 2019 Home Health Payment Rate Update
    D. Rural Add-On Payments for CYs 2019 Through 2022
    E. Payments for High-Cost Outliers Under the HH PPS
    F. Implementation of the Patient-Driven Groupings Model (PDGM) 
for CY 2020
    G. Changes Regarding Certifying and Recertifying Patient 
Eligibility for Medicare Home Health Services
    H. The Role of Remote Patient Monitoring Under the Medicare Home 
Health Benefit
IV. Home Health Value-Based Purchasing (HHVBP) Model
    A. Background
    B. Quality Measures
    C. Performance Scoring Methodology
    D. Update on the Public Display of Total Performance Scores
V. Home Health Quality Reporting Program (HH QRP)
    A. Background and Statutory Authority
    B. General Considerations Used for the Selection of Quality 
Measures for the HH QRP
    C. Removal Factors for Previously Adopted HH QRP Measures
    D. Quality Measures Currently Adopted for the HH QRP
    E. Removal of HH QRP Measures Beginning With the CY 2021 HH QRP
    F. IMPACT Act Implementation Update
    G. Form, Manner, and Timing of OASIS Data Submission
    H. Policies Regarding Public Display for the HH QRP
    I. Home Health Care Consumer Assessment of Healthcare Providers 
and Systems[supreg] (HHCAHPS)
VI. Medicare Coverage of Home Infusion Therapy Services
    A. General Background
    B. Health and Safety Standards for Home Infusion Therapy
    C. Approval and Oversight of Accrediting Organizations for Home 
Infusion Therapy Suppliers
    D. Payment for Home Infusion Therapy Services
VII. Changes to the Accreditation Requirements for Certain Medicare 
Certified Providers and Suppliers
    A. Background
    B. Changes to Certain Requirements for Medicare-Certified 
Providers and Suppliers at Part 488
VIII. Requests for Information
IX. Collection of Information Requirements
    A. Wage Estimates
    B. ICRs Regarding the OASIS
    C. ICRs Regarding Home Infusion Therapy
    D. ICRs Regarding the Approval and Oversight of Accrediting 
Organizations for Home Infusion Therapy
X. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    D. Detailed Economic Analysis
    E. Alternatives Considered
    F. Accounting Statement and Tables
    G. Regulatory Reform Analysis Under E.O. 13771
    H. Conclusion
Regulation Text

I. Executive Summary

A. Purpose

1. Home Health Prospective Payment System (HH PPS)
    This final rule with comment period updates the payment rates for 
home health agencies (HHAs) for calendar year (CY) 2019, as required 
under section 1895(b) of the Social Security Act (the Act). This rule 
also updates the case-mix weights under sections 1895(b)(4)(A)(i) and 
(b)(4)(B) of the Act for CY 2019. For home health services beginning on 
or after January 1, 2020, this rule finalizes case-mix methodology 
refinements, which eliminate the use of therapy thresholds for case-mix 
adjustment purposes; and changes the unit of payment from a 60-day 
episode of care to a 30-day period of care, as mandated by section 
51001 of the Bipartisan Budget Act of 2018 (hereinafter referred to as 
the ``BBA of 2018''). This final rule with comment period also: 
Finalizes the methodology used to determine rural add-on payments for 
CYs 2019 through 2022, as required by section 50208 of the BBA of 2018; 
finalizes regulations text changes regarding certifying and 
recertifying patient eligibility for Medicare home health services 
under sections 1814(a) and 1835(a) of the Act; and finalizes our 
proposal on how to define ``remote patient monitoring'' under the 
Medicare home health benefit and include the costs of such monitoring 
as an allowable administrative costs. Lastly, this rule finalizes 
changes to the Home Health Value Based Purchasing (HHVBP) Model under 
the authority of section 1115A of the Act, and the Home Health Quality 
Reporting Program (HH QRP) requirements under the authority of section 
1895(b)(3)(B)(v) of the Act.
2. Home Infusion Therapy Services
a. Payment for Home Infusion Therapy Services
    This final rule with comment period establishes a transitional 
payment for home infusion therapy services for CYs 2019 and 2020, as 
required by section 50401 of the BBA of 2018. In addition, this rule 
finalizes health and safety standards for home infusion therapy and an 
accreditation and oversight process for qualified home infusion therapy 
suppliers.
b. Safety Standards for Home Infusion Therapy Services
    This final rule with comment period implements health and safety 
standards for qualified home infusion therapy suppliers as required by 
section 5012 of the 21st Century Cures Act. These standards provide a 
foundation for ensuring patient safety and quality care by establishing 
requirements for the plan of care to be initiated and updated by a 
physician; 7-day-a-week, 24-hour-a-day access to services and remote 
monitoring; and patient education and training regarding their home 
infusion therapy care.
c. Accreditation of Home Infusion Therapy Suppliers
    This final rule with comment period also implements regulations for 
the approval and oversight of AOs that accredit home infusion therapy 
suppliers.

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B. Summary of the Major Provisions

1. Home Health Prospective Payment System (HH PPS)
    In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our 
proposal to recalibrate the case-mix weights every year with the most 
current and complete data available at the time of rulemaking. In 
section III.B. of this rule, we are recalibrating the HH PPS case-mix 
weights, using the most current cost and utilization data available, in 
a budget-neutral manner. In section III.C. of this rule, we are 
finalizing the rebasing of the home health market basket and updates to 
the payment rates under the HH PPS by the home health payment update 
percentage of 2.2 percent (using the 2016-based Home Health Agency 
(HHA) market basket update of 3.0 percent, minus 0.8 percentage point 
for multifactor productivity) as required by section 
1895(b)(3)(B)(vi)(I) of the Act. Also in section III.C. of this final 
rule with comment period, we are finalizing a reduction in the labor-
related share from 78.5 to 76.1 percent of total costs on account of 
the rebasing of the home health market basket. Lastly, in section 
III.C. of this rule, we update the CY 2019 home health wage index using 
FY 2015 hospital cost report data. In section III.D. of this final rule 
with comment period, we are finalizing a methodology for applying rural 
add-on payments for CYs 2019 through 2022, as required by section 50208 
of the BBA of 2018. In section III.E. of this rule, we are finalizing a 
reduction to the fixed-dollar loss ratio from 0.55 to 0.51 for CY 2019 
in order to increase outlier payments as a percentage of total payments 
so that this percentage is closer to, but no more than, 2.5 percent.
    In section III.F. of this rule, we are finalizing case-mix 
methodology refinements and a change in the unit of payment from a 60-
day episode of care to a 30-day period of care effective January 1, 
2020 and in a budget neutral manner, as required by section 51001 of 
the BBA of 2018. The ``Patient-Driven Groupings Model'', or 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 51001(a)(3) of the BBA of 2018, that are currently used to 
case-mix adjust payments under the HH PPS.
    In section III.G. of this rule, we are finalizing regulation text 
changes at 42 CFR 424.22(b)(2) to eliminate the requirement that the 
certifying physician must estimate how much longer skilled services 
will be needed as part of the recertification statement. In addition, 
in section III.G of this rule, consistent with section 51002 of the BBA 
of 2018, we are finalizing a proposal to align the regulations text at 
Sec.  424.22(c) with current subregulatory guidance to allow medical 
record documentation from the HHA to be used to support the basis for 
certification and/or recertification of home health eligibility, if 
certain requirements are met.
    In section III.H. of this rule, we are finalizing our proposal to 
define ``remote patient monitoring'' under the Medicare home health 
benefit and changes to the regulations at Sec.  409.46 to include costs 
of remote patient monitoring as allowable administrative costs.
2. Home Health Value Based Purchasing
    In section IV. of this final rule with comment period, we are 
finalizing changes to the Home Health Value Based Purchasing (HHVBP) 
Model implemented January 1, 2016. Specifically, we are finalizing, 
beginning with performance year (PY) 4, the following policy changes: 
removal of two Outcome and Assessment Information Set (OASIS) based 
measures, Influenza Immunization Received for Current Flu Season and 
Pneumococcal Polysaccharide Vaccine Ever Received, from the set of 
applicable measures; replacement of three OASIS-based measures 
(Improvement in Ambulation-Locomotion, Improvement in Bed Transferring, 
and Improvement in Bathing) with two new composite measures on total 
normalized composite change in self-care and mobility; changes to how 
we calculate the Total Performance Scores by changing the weighting 
methodology for the OASIS-based, claims-based, and HHCAHPS measures; 
and a change to the scoring methodology by reducing the maximum amount 
of improvement points an HHA can earn, from 10 points to 9 points. We 
are also providing an update on the progress towards developing public 
reporting of performance under the HHVBP Model and providing a summary 
of public comments received in response to our solicitation of feedback 
on what information we should consider making publicly available in the 
future.
3. Home Health Quality Reporting Program
    In section V. of this final rule with comment period, we are 
finalizing updates to our the Home Health (HH) Quality Reporting 
Program (QRP) by adopting eight measure removal factors, removing seven 
measures, and updating our regulations to clarify that not all OASIS 
data are required for the HH QRP. We are also providing an update on 
the implementation of certain provisions of the IMPACT Act, and are 
finalizing our proposal to increase the number of years of data used to 
calculate the Medicare Spending per Beneficiary measure for purposes of 
display from 1 year to 2 years.
4. Home Infusion Therapy
    In section VI.A. of this final rule with comment period, we discuss 
general background of home infusion therapy services and how this 
relates to the implementation of the new home infusion benefit. In 
section VI.B. of this final rule with comment period, we have finalized 
the addition of a new subpart I under the regulations at 42 CFR part 
486 to incorporate health and safety requirements for home infusion 
therapy suppliers. These regulations provide a framework for CMS to 
approve home infusion therapy accreditation organizations. Subpart I 
includes General Provisions (Scope and Purpose, and Definitions) and 
Standards for Home Infusion Therapy (Plan of Care and Required 
Services). Section VI.D. of this final rule with comment period 
provides information on temporary transitional payments for home 
infusion therapy services for CYs 2019 and 2020 as mandated by section 
50401 of the BBA of 2018, and responds to the comments received 
regarding issues such as the regulatory definition of ``Infusion Drug 
Administration Calendar Day.''
    In section VI.C. of this final rule with comment period, we discuss 
the requirements set forth in section 1861(iii)(3)(D)(III) of the Act, 
which mandates that suppliers of home infusion therapy receive 
accreditation from a CMS-approved accrediting organization (AO) in 
order to receive Medicare payment. The Secretary must designate AOs to 
accredit suppliers furnishing home infusion therapy not later than 
January 1, 2021. Qualified home infusion therapy suppliers are required 
to receive accreditation before receiving Medicare payment for services 
provided to Medicare beneficiaries.
    Until now, no regulations have addressed the following elements of 
CMS' approval and oversight of the AOs that accredit suppliers of home 
infusion therapy: (1) The required components to be included in a home 
infusion therapy AO's initial or renewal accreditation program 
application; (2) regulations related to CMS' review and approval of the 
home infusion therapy AOs application for approval of its accreditation 
program; and (3) the

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ongoing monitoring and oversight of CMS approved home infusion therapy 
AOs. However, this final rule with comment period finalizes a set of 
regulations that will govern the CMS approval and oversight process for 
all home infusion therapy AOs.
    In this final rule with comment period, we are not finalizing our 
proposal to modify 42 CFR 488.5 by adding a requirement that all 
surveyors, that work for AOs that accredit Medicare certified providers 
and suppliers, must complete the relevant program specific CMS online 
trainings.
    However, in this final rule with comment period, we are finalizing 
the proposed requirement to be added at Sec.  488.5 which requires the 
AOs for Medicare certified providers and suppliers to provide a written 
statement with their application stating that if a fully accredited 
facility deemed to be in good-standing provides written notification 
that they wish to voluntarily withdraw from the AO's CMS-approved 
accreditation program, the AO must continue the facility's current 
accreditation until the effective date of withdrawal identified by the 
facility or the expiration date of the term of accreditation, whichever 
comes first.

C. Summary of Costs, Transfers, and Benefits

BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TR13NO18.001

BILLING CODE 4120-01-C

D. Improving Patient Outcomes and Reducing Burden Through Meaningful 
Measures

    In the CY 2019 HH PPS proposed rule, we stated that regulatory 
reform and reducing regulatory burden are high priorities for us. To 
reduce the regulatory burden on the healthcare industry, lower health 
care costs, and enhance patient care, in October 2017, we launched the 
Meaningful Measures Initiative.\1\ This initiative is one component of 
our agency-wide Patients Over Paperwork Initiative \2\ which is aimed 
at evaluating and streamlining regulations with a goal to reduce 
unnecessary cost and burden, increase efficiencies, and improve 
beneficiary experience. The Meaningful Measures Initiative is aimed at 
identifying the highest priority areas for quality

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measurement and quality improvement in order to assess the core quality 
of care issues that are most vital to advancing our work to improve 
patient outcomes. The Meaningful Measures Initiative represents a new 
approach to quality measures that fosters operational efficiencies, and 
will reduce costs including, the collection and reporting burden while 
producing quality measurement that is more focused on meaningful 
outcomes.
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    \1\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    \2\ See Remarks by Administrator Seema Verma at the Health Care 
Payment Learning and Action Network (LAN) Fall Summit, as prepared 
for delivery on October 30, 2017 https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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    The Meaningful Measures Framework has the following objectives:
     Address high-impact measure areas that safeguard public 
health;
     Patient-centered and meaningful to patients;
     Outcome-based where possible;
     Fulfill each program's statutory requirements;
     Minimize the level of burden for health care providers 
(for example, through a preference for EHR-based measures where 
possible, such as electronic clinical quality measures);
     Provide significant opportunity for improvement;
     Address measure needs for population based payment through 
alternative payment models; and
     Align across programs and/or with other payers.
    In order to achieve these objectives, stated in the proposed rule 
that we had identified 19 Meaningful Measures areas and mapped them to 
six overarching quality priorities as shown in Table 2:
[GRAPHIC] [TIFF OMITTED] TR13NO18.002

    By including Meaningful Measures in our programs, we stated our 
belief that we can also address the following cross-cutting measure 
criteria:
     Eliminating disparities;
     Tracking measurable outcomes and impact;
     Safeguarding public health;
     Achieving cost savings;
     Improving access for rural communities; and
     Reducing burden.
    We also stated the we believe that the Meaningful Measures 
Initiative will improve outcomes for patients, their families, and 
health care providers while reducing burden and costs for clinicians 
and providers and promoting operational efficiencies.

II. Background

A. Statutory Background

1. Home Health Prospective Payment System
a. Background
    The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted 
August 5, 1997), significantly changed the way Medicare pays for 
Medicare home health services. Section 4603 of the BBA mandated the 
development of the HH PPS. Until the implementation of the HH PPS on 
October 1, 2000, HHAs received payment under a retrospective 
reimbursement system.
    Section 4603(a) of the BBA mandated the development of a HH PPS for 
all Medicare-covered home health services provided under a plan of care 
(POC) that were paid on a reasonable cost basis by adding section 1895 
of the Act, entitled ``Prospective Payment For Home Health Services.'' 
Section 1895(b)(1) of the Act requires the Secretary to establish a HH 
PPS for all costs of home health services paid under Medicare. Section 
1895(b)(2) of the Act requires 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 requires 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

[[Page 56412]]

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 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 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 65884, 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 final rule with comment 
period.

B. Current System for Payment of Home Health Services

    Generally, Medicare currently makes payment under the HH PPS on the 
basis of a national, standardized 60-day episode payment rate that is 
adjusted for the applicable case-mix and wage index. The national, 
standardized 60-day episode rate includes the six home health 
disciplines (skilled nursing, home health aide, physical therapy, 
speech-language pathology, occupational therapy, and medical social 
services). Payment for non-routine supplies (NRS) is not part of the 
national, standardized 60-day episode rate, but is computed by 
multiplying the relative weight for a particular NRS severity level by 
the NRS conversion factor. Payment for durable medical equipment 
covered under the HH benefit is made outside the HH PPS payment system. 
To adjust for case-mix, the HH PPS uses a 153-category case-mix 
classification system to assign patients to a home health resource 
group (HHRG). The clinical severity level, functional severity level, 
and service utilization are computed from responses to selected data 
elements in the 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. Updates to the Home Health Prospective Payment System

    As required by section 1895(b)(3)(B) of the Act, we have 
historically updated the HH PPS rates annually in the Federal Register. 
The August 29, 2007

[[Page 56413]]

final rule with comment period set forth an update to the 60-day 
national episode rates and the national per-visit rates under the HH 
PPS for CY 2008. The CY 2008 HH PPS final rule included an analysis 
performed on CY 2005 home health claims data, which indicated a 12.78 
percent increase in the observed case-mix since 2000. Case-mix 
represents the variations in conditions of the patient population 
served by the HHAs. Subsequently, a more detailed analysis was 
performed on the 2005 case-mix data to evaluate if any portion of the 
12.78 percent increase was associated with a change in the actual 
clinical condition of home health patients. We identified 8.03 percent 
of the total case-mix change as real, and therefore, decreased the 
12.78 percent of total case-mix change by 8.03 percent to get a final 
nominal case-mix increase measure of 11.75 percent (0.1278 * (1-0.0803) 
= 0.1175).
    To account for the changes in case-mix that were not related to an 
underlying change in patient health status, we implemented a reduction, 
over 4 years, to the national, standardized 60-day episode payment 
rates. That reduction was to be 2.75 percent per year for 3 years 
beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011. 
In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses 
of case-mix change and finalized a reduction of 3.79 percent, instead 
of 2.71 percent, for CY 2011 and deferred finalizing a payment 
reduction for CY 2012 until further study of the case-mix change data 
and methodology was completed.
    In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-
day national episode rates and the national per-visit rates. In 
addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528), 
our analysis indicated that there was a 22.59 percent increase in 
overall case-mix from 2000 to 2009 and that only 15.76 percent of that 
overall observed case-mix percentage increase was due to real case-mix 
change. As a result of our analysis, we identified a 19.03 percent 
nominal increase in case-mix. At that time, to fully account for the 
19.03 percent nominal case-mix growth identified from 2000 to 2009, we 
finalized a 3.79 percent payment reduction in CY 2012 and a 1.32 
percent payment reduction for CY 2013.
    In the CY 2013 HH PPS final rule (77 FR 67078), we implemented the 
1.32 percent reduction to the payment rates for CY 2013 finalized the 
previous year, to account for nominal case-mix growth from 2000 through 
2010. When taking into account the total measure of case-mix change 
(23.90 percent) and the 15.97 percent of total case-mix change 
estimated as real from 2000 to 2010, we obtained a final nominal case-
mix change measure of 20.08 percent from 2000 to 2010 (0.2390 * (1-
0.1597) = 0.2008). To fully account for the remainder of the 20.08 
percent increase in nominal case-mix beyond that which was accounted 
for in previous payment reductions, we estimated that the percentage 
reduction to the national, standardized 60-day episode rates for 
nominal case-mix change would be 2.18 percent. Although we considered 
proposing a 2.18 percent reduction to account for the remaining 
increase in measured nominal case-mix, we finalized the 1.32 percent 
payment reduction to the national, standardized 60-day episode rates in 
the CY 2012 HH PPS final rule (76 FR 68532). Section 3131(a) of the 
Affordable Care Act added new section 1895(b)(3)(A)(iii) to the Act, 
which required that, beginning in CY 2014, we apply an adjustment to 
the national, standardized 60-day episode rate and other amounts that 
reflect factors such as changes in the number of visits in an episode, 
the mix of services in an episode, the level of intensity of services 
in an episode, the average cost of providing care per episode, and 
other relevant factors. Additionally, we were required to phase in any 
adjustment over a 4-year period in equal increments, not to exceed 3.5 
percent of the payment amount (or amounts) as of the date of enactment 
of the Affordable Care Act in 2010, and fully implement the rebasing 
adjustments by CY 2017. Therefore, in the CY 2014 HH PPS final rule (78 
FR 72256) for each year, CY 2014 through CY 2017, we finalized a fixed-
dollar reduction to the national, standardized 60-day episode payment 
rate of $80.95 per year, increases to the national per-visit payment 
rates per year, and a decrease to the NRS conversion factor of 2.82 
percent per year. We also finalized three separate LUPA add-on factors 
for skilled nursing, physical therapy, and speech-language pathology 
and removed 170 diagnosis codes from assignment to diagnosis groups in 
the HH PPS Grouper. In the CY 2015 HH PPS final rule (79 FR 66032), we 
implemented the second year of the 4-year phase-in of the rebasing 
adjustments to the HH PPS payment rates and made changes to the HH PPS 
case-mix weights. In addition, we simplified the face-to-face encounter 
regulatory requirements and the therapy reassessment timeframes.
    In the CY 2016 HH PPS final rule (80 FR 68624), we implemented the 
third year of the 4-year phase-in of the rebasing adjustments to the 
national, standardized 60-day episode payment amount, the national per-
visit rates and the NRS conversion factor (as discussed previously). In 
the CY 2016 HH PPS final rule, we also recalibrated the HH PPS case-mix 
weights, using the most current cost and utilization data available, in 
a budget-neutral manner and finalized reductions to the national, 
standardized 60-day episode payment rate in CY 2016, CY 2017, and CY 
2018 of 0.97 percent in each year to account for estimated case-mix 
growth unrelated to increases in patient acuity (that is, nominal case-
mix growth) between CY 2012 and CY 2014. Finally, section 421(a) of the 
MMA, as amended by section 210 of the MACRA, extended the payment 
increase of 3 percent for HH services provided in rural areas (as 
defined in section 1886(d)(2)(D) of the Act) to episodes or visits 
ending before January 1, 2018.
    In the CY 2017 HH PPS final rule (81 FR 76702), we implemented the 
last year of the 4-year phase-in of the rebasing adjustments to the 
national, standardized 60-day episode payment amount, the national per-
visit rates and the NRS conversion factor (as outlined previously). We 
also finalized changes to the methodology used to calculate outlier 
payments under the authority of section 1895(b)(5) of the Act. Lastly, 
in accordance with section 1834(s) of the Act, as added by section 
504(a) of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113, 
enacted December 18, 2015), we implemented changes in payment for 
furnishing Negative Pressure Wound Therapy (NPWT) using a disposable 
device for patients under a home health plan of care for which payment 
would otherwise be made under section 1895(b) of the Act.
2. Home Infusion Therapy
    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

[[Page 56414]]

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 would begin on January 1, 2019 and 
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.
    Home infusion therapy is a treatment option for patients with a 
wide range of acute and chronic conditions, ranging from bacterial 
infections to more complex conditions such as late-stage heart failure 
and immune deficiencies. Home infusion therapy affords a patient 
independence and better quality of life, because it is provided in the 
comfort of the patient's home at a time that best fits his or her 
needs. This is significant, because generally patients can return to 
their daily activities after they receive their infusion treatments 
and, in many cases, they can continue their activities while receiving 
their treatments. In addition, home infusion therapy can provide 
improved safety and better outcomes. The home has been shown to be a 
safe setting for patients to receive infusion therapy.\3\ Additionally, 
patients receiving treatment outside of the hospital setting may be at 
lower risk of hospital-acquired infections, which can be more difficult 
to treat because of multidrug resistance than those that are community-
acquired. This is particularly important for vulnerable patients such 
as those who are immunocompromised, as hospital-acquired infections are 
increasingly caused by antibiotic-resistant pathogens.
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    \3\ Bhole, M.V., Burton, J., & Chapel, H.M., (2008). Self-
infusion programs for immunoglobulin replacement at home: 
Feasibility, safety and efficacy. Immunology and Allergy Clinics of 
North America, 28(4), 821-832. doi:10.1016/j.iac.2008.06.005.
    Souayah, N., Hasan, A., Khan, H., et al. (2011). The safety 
profile of home infusion of intravenous immunoglobulin in patients 
with neuroimmunologic disorders. Journal of Clinical Neuromuscular 
Disease, 12(supp 4), S1-10. doi: 10.1097/CND.0b013e3182212589.
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    Infusion therapy typically means that a drug is administered 
intravenously, but the term may also refer to situations where drugs 
are provided through other non-oral routes, such as intramuscular 
injections and epidural routes (into the membranes surrounding the 
spinal cord). Diseases that may require infusion therapy include 
infections that are unresponsive to oral antibiotics, cancer and 
cancer-related pain, dehydration, and gastrointestinal diseases or 
disorders which prevent normal functioning of the gastrointestinal 
system. Other conditions treated with specialty infusion therapies may 
include some forms of cancers, congestive heart failure, Crohn's 
Disease, hemophilia, hepatitis, immune deficiencies, multiple sclerosis 
and rheumatoid arthritis. Infusion therapy originates with a 
prescription order from a physician or another qualified prescriber who 
is overseeing the care of the patient. The prescription order is sent 
to a home infusion therapy supplier, which is a state-licensed 
pharmacy, physician, or other provider of services or suppliers 
licensed by the state.
    A 2010 Government Accountability Office (GAO) report (10-426) found 
that most health insurers rely on credentialing, accreditation, or both 
to help ensure that plan members receive quality home infusion services 
from their network suppliers.\4\ Home infusion AOs conduct on-site 
surveys to evaluate all components of the service, including medical 
equipment, nursing, and pharmacy. Accreditation standards can include 
such requirements as the CMS Conditions of Participation for home 
health services, other Federal government regulations, and industry 
best practices. All of the accreditation standards evaluate a range of 
provider competencies, such as having a complete plan of care, response 
to adverse events, and implementation of a quality improvement plan.
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    \4\ https://www.gao.gov/assets/310/305261.pdf.
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    Sections 1861(iii)(3)(D)(III) and 1834(u)(5) of the Act, as amended 
by section 5012 of the Cures Act requires that, in order to participate 
in Medicare, home infusion therapy suppliers must select a CMS-approved 
AO and undergo an accreditation review process to demonstrate that the 
home infusion therapy program meets the accreditation organization's 
standards. Section 1861(iii) of the Act, as amended by section 5012 of 
the Cures Act, sets forth standards in three areas: (1) Ensuring that 
all patients have a plan of care established and updated by a physician 
that sets out the care and prescribed infusion therapy necessary to 
meet the patient-specific needs; (2) having procedures to ensure that 
remote monitoring services associated with administering infusion drugs 
in a patient's home are provided; and (3) having procedures to ensure 
that patients receive education and training on the effective use of 
medications and equipment in the home.

III. Provisions of the Proposed Rule: Payment Under the Home Health 
Prospective Payment System (HH PPS) and Responses to Comments

    In the July 12, 2018 Federal Register (83 FR 32340 through 32522), 
we published the proposed rule titled ``Medicare and Medicaid Programs; 
CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 
Case-Mix Adjustment Methodology Refinements; Home Health Value-Based 
Purchasing Model; Home Health Quality Reporting Requirements; Home 
Infusion Therapy Requirements; and Training Requirements for Surveyors 
of National Accrediting Organizations''. We received approximately 
1,125 timely comments from the public, including comments from home 
health agencies, home infusion therapy providers, DME suppliers, 
manufacturers of remote patient monitoring technology, national and 
state provider associations, patient and other advocacy organizations, 
physicians, nurses, therapists, pharmacists, and accrediting 
organizations. In the following sections, we summarize the proposed 
provisions and the public comments, and provide the responses to 
comments.

A. Monitoring for Potential Impacts--Affordable Care Act Rebasing 
Adjustments

    In the CY 2019 proposed rule (83 FR 32348), we provided a summary 
of analysis on fiscal (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. In addition, we presented information 
on Medicare home health utilization statistics and trends that included 
HHA claims data through CY 2017. We will continue monitoring the 
impacts due to the rebasing adjustments and other policy changes and 
will provide the industry with periodic updates on our analysis in 
rulemaking and/or announcements on the HHA Center web page at: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.

B. CY 2019 HH PPS Case-Mix Weights

    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. To recalibrate the HH PPS case-mix weights for CY 2019, 
we will use the same methodology finalized in the CY 2008

[[Page 56415]]

HH PPS final rule (72 FR 49762), the CY 2012 HH PPS final rule (76 FR 
68526), and the CY 2015 HH PPS final rule (79 FR 66032). 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.
    To generate the final CY 2019 HH PPS case-mix weights, we used CY 
2017 home health claims data (as of June 30, 2018) with linked OASIS 
data. These data are the most current and complete data available at 
this time. We noted in the proposed rule that we would use CY 2017 home 
health claims data (as of June 30, 2018 or later) with linked OASIS 
data to generate the CY 2019 HH PPS case-mix weights for this final 
rule with comment period. The process we used to calculate the HH PPS 
case-mix weights is outlined in this section.
    Step 1: Re-estimate the four-equation model to determine the 
clinical and functional points for an episode using wage-weighted 
minutes of care as our dependent variable for resource use. The wage-
weighted minutes of care are determined using the CY 2016 Bureau of 
Labor Statistics national hourly wage plus fringe rates for the six 
home health disciplines and the minutes per visit from the claim. The 
points for each of the variables for each leg of the model, updated 
with CY 2017 home health claims data, are shown in Table 3. The points 
for the clinical variables are added together to determine an episode's 
clinical score. The points for the functional variables are added 
together to determine an episode's functional score.
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    In updating the four-equation model for CY 2019, using 2017 home 
health claims data (the last update to the four-equation model for CY 
2018 used CY 2016 home health claims data), there were few changes to 
the point values for the variables in the four-equation model. These 
relatively minor changes reflect the change in the relationship between 
the grouper variables and resource use between CY 2016 and CY 2017. The 
final CY 2019 four-equation model resulted in 119 point-giving 
variables being used in the model (as compared to the 119 variables for 
the CY 2018 recalibration, which can be found in Table 2 of the CY 2018 
HH PPS final rule (82 FR 51684)). There were 9 variables that were 
added to the model due to the presence of additional resources 
associated with those variables and 9 variables that were dropped from 
the model due to the absence of additional resources associated with 
those variables. Of the variables that were in both the four-equation 
model for CY 2019 and the four-equation model for CY 2018, the points 
for 7 variables increased in the CY 2019 four-equation model and the 
points for 68 variables decreased in the CY 2019 4-equation model. 
There were 35 variables with the same point values.
    Step 2: Redefining the clinical and functional thresholds so they 
are reflective of the new points associated with the CY 2019 four-
equation model. After estimating the points for each of the variables 
and summing the clinical and functional points for each episode, we 
look at the distribution of the clinical score and functional score, 
breaking the episodes into different steps. The categorizations for the 
steps are as follows:
     Step 1: First and second episodes, 0-13 therapy visits.
     Step 2.1: First and second episodes, 14-19 therapy visits.
     Step 2.2: Third episodes and beyond, 14-19 therapy visits.
     Step 3: Third episodes and beyond, 0-13 therapy visits.
     Step 4: Episodes with 20+ therapy visits.
    Then, we divide the distribution of the clinical score for episodes 
within a step such that a third of episodes are classified as low 
clinical score, a third of episodes are classified as medium clinical 
score, and a third of episodes are classified as high clinical score. 
The same approach is then done looking at the functional score. It was 
not always possible to evenly divide the episodes within each step into 
thirds due to many episodes being clustered around one particular 
score.\5\
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    \5\ For Step 1, 33.7 percent of episodes were in the medium 
functional level (All with score 13). For Step 2.1, 86.7% of 
episodes were in the low functional level (Most with scores 6 to 7). 
For Step 2.2, 81.5 percent of episodes were in the low functional 
level (Most with score 0). For Step 3, 46.6 percent of episodes were 
in the medium functional level (Most with score 9). For Step 4, 33.2 
percent of episodes were in the medium functional level (Most with 
score 6).
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    Also, we looked at the average resource use associated with each 
clinical and functional score and used that as a guide for setting our 
thresholds. We grouped scores with similar average resource use within 
the same level (even if it meant that more or less than a third of 
episodes were placed within a level). The new thresholds, based off the 
final CY 2019 four-equation model points are shown in Table 4.

[[Page 56419]]

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    Step 3: Once the clinical and functional thresholds are determined 
and each episode is assigned a clinical and functional level, the 
payment regression is estimated with an episode's wage-weighted minutes 
of care as the dependent variable. Independent variables in the model 
are indicators for the step of the episode as well as the clinical and 
functional levels within each step of the episode. Like the four-
equation model, the payment regression model is also estimated with 
robust standard errors that are clustered at the beneficiary level. 
Table 5 shows the regression coefficients for the variables in the 
payment regression model updated with CY 2017 home health claims data. 
The R-squared value for the final CY 2019 payment regression model is 
0.5429 (an increase from 0.5095 for the CY 2018 recalibration).

[[Page 56420]]

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    Step 4: We use the coefficients from the payment regression model 
to predict each episode's wage-weighted minutes of care (resource use). 
We then divide these predicted values by the mean of the dependent 
variable (that is, the average wage- weighted minutes of care across 
all episodes used in the payment regression). This division constructs 
the weight for each episode, which is simply the ratio of the episode's 
predicted wage-weighted minutes of care divided by the average wage-
weighted minutes of care in the sample. Each episode is then aggregated 
into one of the 153 home health resource groups (HHRGs) and the ``raw'' 
weight for each HHRG was calculated as the average of the episode 
weights within the HHRG.
    Step 5: The raw weights associated with 0 to 5 therapy visits are 
then increased by 3.75 percent, the weights associated with 14-15 
therapy visits are decreased by 2.5 percent, and the weights associated 
with 20+ therapy visits are decreased by 5 percent. These adjustments 
to the case-mix weights were finalized in the CY 2012 HH PPS final rule 
(76 FR 68557) and were done to address concerns that the HH PPS over-
values therapy episodes and undervalues non-therapy episodes and to 
better align the case-mix weights with episode costs estimated from 
cost report data.\6\
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    \6\ Medicare Payment Advisory Commission (MedPAC), Report to 
Congress: Medicare Payment Policy. March 2011, page 176.
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    Step 6: After the adjustments in step 5 are applied to the raw 
weights, the weights are further adjusted to create an increase in the 
payment weights for the therapy visit steps between the therapy 
thresholds. Weights with the same clinical severity level, functional 
severity level, and early/later episode status were grouped together. 
Then within those groups, the weights for each therapy step between 
thresholds are gradually increased. We do this by interpolating between 
the main thresholds on the model (from 0-5 to 14-15 therapy visits, and 
from 14-15 to 20+ therapy visits). We use a linear model to implement 
the interpolation so the payment weight increase for each step between 
the thresholds (such as the increase between 0-5 therapy visits and 6 
therapy visits and the increase between 6 therapy visits and 7-9 
therapy visits) are constant. This interpolation is identical to the 
process finalized in the CY 2012 HH PPS final rule (76 FR 68555).

[[Page 56421]]

    Step 7: The interpolated weights are then adjusted so that the 
average case-mix for the weights is equal to 1.0000.\7\ This last step 
creates the CY 2019 case-mix weights shown in Table 6.
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    \7\ When computing the average, we compute a weighted average, 
assigning a value of one to each normal episode and a value equal to 
the episode length divided by 60 for PEPs.
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    To ensure the changes to the HH PPS case-mix weights are 
implemented in a budget neutral manner, we then apply a case-mix budget 
neutrality factor to the CY 2019 national, standardized 60-day episode 
payment rate (see section III.C.3. of this final rule with comment 
period). The case-mix budget neutrality factor is calculated as the 
ratio of total payments when the CY 2019 HH PPS case-mix weights 
(developed using CY 2017 home health claims data) are applied to CY 
2017 utilization (claims) data to total payments when CY 2018 HH PPS 
case-mix weights (developed using CY 2016 home health claims data) are 
applied to CY 2017 utilization data. This produces a case-mix budget 
neutrality factor for CY 2019 of 1.0169.
    The following is a summary of the comments received and our 
responses to comments on the CY 2019 HH PPS case-mix weights.
    Comment: Some commenters believe that CMS should not recalibrate 
the case-mix weights for CY 2019 because annual changes are too 
frequent. Other commenters indicated that CMS should provide more 
detail on how the recalibration works and why the model is recalibrated 
every year.
    Response: As stated in the CY 2019 HH PPS proposed rule (83 FR 
32340), the methodology used to recalibrate the weights is identical to 
the methodology used in the CY 2012 recalibration except for the minor 
exceptions as noted in the CY 2015 HH PPS proposed and final rules (79 
FR 38366 and 79 FR 66032, respectively). In the CY 2015 HH PPS final 
rule, we finalized annual recalibration and the methodology to be used 
for each year's recalibration (79 FR 66072). As stated in the CY 2019 
HH PPS proposed rule (83 FR 32353), 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. For more detail, we also encourage commenters to 
refer to the CY 2012 HH PPS proposed and final rules (76 FR 40988 and 
76 FR 68526, respectively) and the November 1, 2011 ``Revision of the 
Case-Mix Weights for the HH PPS Report'' on our home page at: https://www.cms.gov/center/provider-Type/home-Health-AgencyHHA-Center.html for 
additional information about the recalibration methodology. We note 
that in comparing the final CY 2019 HH PPS case-mix weights (see Table 
6) to the final CY 2018 HH PPS case-mix weights (82 FR 51676), the 
case-mix weights change very little, with most case-mix weights either 
increasing or decreasing by 1 to 2 percent with no case-mix weights 
increasing by more than 3 percent or decreasing by more than 3 percent. 
Aggregate increases or decreases in the case-mix weights are offset by 
the case-mix budget neutrality factor, which is applied to the 
national, standardized 60-day episode payment rate. In other words, 
although the case-mix weights themselves may increase or decrease from 
year-to-year, we correspondingly offset any estimated increases or 
decreases in total payments under the HH PPS, as a result of the case-
mix recalibration, by applying a budget neutrality factor to the 
national, standardized 60-day episode payment rate. For CY 2019, the 
case-mix budget neutrality factor will be 1.0169 as described 
previously. The recalibration of the case-mix weights is not intended 
to increase or decrease overall HH PPS payments, but rather is used to 
update the relative differences in resource use amongst the 153 groups 
in the HH PPS case-mix system to reflect current practice patterns.
    Comment: Another commenter suggested that CMS should adjust for any 
nominal case-mix changes observed between 2015 and 2017.
    Response: We will continue to monitor real and nominal case-mix 
growth and may propose additional

[[Page 56425]]

reductions for nominal case-mix growth, as needed, in the future.
    Final Decision: We are finalizing the recalibrated scores for the 
case-mix adjustment variables, clinical and functional thresholds, 
payment regression model, and case-mix weights in Tables 3 through 6. 
For this final rule with comment period, the CY 2019 scores for the 
case-mix variables, the clinical and functional thresholds, and the 
case-mix weights were developed using complete CY 2017 claims data as 
of June 30, 2018. We note that we finalized the recalibration 
methodology and the proposal to annually recalibrate the HH PPS case-
mix weights in the CY 2015 HH PPS final rule (79 FR 66072). No 
additional proposals were made with regards to the recalibration 
methodology in the CY 2019 HH PPS proposed rule.

C. CY 2019 Home Health Payment Rate Update

1. Rebasing and Revising of the Home Health Market Basket
a. Background
    Section 1895(b)(3)(B) of the Act requires that the standard 
prospective payment amounts for CY 2019 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. Effective for cost 
reporting periods beginning on or after July 1, 1980, we developed and 
adopted an HHA input price index (that is, the home health ``market 
basket''). Although ``market basket'' technically describes the mix of 
goods and services used to produce home health care, this term is also 
commonly used to denote the input price index derived from that market 
basket. Accordingly, the term ``home health market basket'' used in 
this document refers to the HHA input price index.
    The percentage change in the home health market basket reflects the 
average change in the price of goods and services purchased by HHAs in 
providing an efficient level of home health care services. We first 
used the home health market basket to adjust HHA cost limits by an 
amount that reflected the average increase in the prices of the goods 
and services used to furnish reasonable cost home health care. This 
approach linked the increase in the cost limits to the efficient 
utilization of resources. For a greater discussion on the home health 
market basket, see the notice with comment period published in the 
February 15, 1980 Federal Register (45 FR 10450 and 10451), the notice 
with comment period published in the February 14, 1995 Federal Register 
(60 FR 8389 through 8392), and the notice with comment period published 
in the July 1, 1996 Federal Register (61 FR 34344 through 34347). 
Beginning with the FY 2002 HHA PPS payments, we used the home health 
market basket to update payments under the HHA PPS. We last rebased the 
home health market basket effective with the CY 2013 update (77 FR 
67081).
    The home health market basket is a fixed-weight, Laspeyres-type 
price index. A Laspeyres-type price index measures the change in price, 
over time, of the same mix of goods and services purchased in the base 
period. Any changes in the quantity or mix of goods and services (that 
is, intensity) purchased over time are not measured.
    The index itself is constructed in three steps. First, a base 
period is selected (in this final rule with comment period, we are 
using 2016 as the base period) and total base period expenditures are 
estimated for a set of mutually exclusive and exhaustive spending 
categories, with the proportion of total costs that each category 
represents being calculated. These proportions are called ``cost 
weights'' or ``expenditure weights.'' Second, each expenditure category 
is matched to an appropriate price or wage variable, referred to as a 
``price proxy.'' In almost every instance, these price proxies are 
derived from publicly available statistical series that are published 
on a consistent schedule (preferably at least on a quarterly basis). 
Finally, the expenditure weight for each cost category is multiplied by 
the level of its respective price proxy. The sum of these products 
(that is, the expenditure weights multiplied by their price index 
levels) for all cost categories yields the composite index level of the 
market basket in a given period. Repeating this step for other periods 
produces a series of market basket levels over time. Dividing an index 
level for a given period by an index level for an earlier period 
produces a rate of growth in the input price index over that timeframe.
    As noted previously, the market basket is described as a fixed-
weight index because it represents the change in price over time of a 
constant mix (quantity and intensity) of goods and services needed to 
provide HHA services. The effects on total expenditures resulting from 
changes in the mix of goods and services purchased subsequent to the 
base period are not measured. For example, a HHA hiring more nurses to 
accommodate the needs of patients would increase the volume of goods 
and services purchased by the HHA, but would not be factored into the 
price change measured by a fixed-weight home health market basket. Only 
when the index is rebased would changes in the quantity and intensity 
be captured, with those changes being reflected in the cost weights. 
Therefore, we rebase the market basket periodically so that the cost 
weights reflect recent changes in the mix of goods and services that 
HHAs purchase (HHA inputs) to furnish inpatient care between base 
periods.
    Comment: A commenter had concerns that the data used for the market 
rebasing does not reflect current costs.
    Response: For the 2016-based home health market basket, we use the 
2016 Medicare cost reports for freestanding HHAs (CMS Form 1728-94) as 
the primary data source; the 2016 data are the most recent and 
comprehensive set of cost report data available to CMS at the time of 
rebasing. As we discussed in the CY 2019 HH PPS proposed rule (83 FR 
32361), we use data from freestanding HHAs, which account for over 90 
percent of HHAs (82 FR 35383), because we have determined that they 
better reflect HHAs' actual cost structure. Expense data for hospital-
based HHAs can be affected by the allocation of overhead costs over the 
entire institution. The 2010-based home health market basket was 
primarily based on the 2010 Medicare cost report data. Therefore, we 
believe that rebasing the home health market basket alleviates the 
concerns that the market basket does not reflect the most current 
costs.
b. Rebasing and Revising the Home Health Market Basket
    We believe that it is desirable to rebase the home health market 
basket periodically so that the cost category weights reflect changes 
in the mix of goods and services that HHAs purchase in furnishing home 
health care. We based the cost category weights in the current home 
health market basket on CY 2010 data. We proposed 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.
    The terms ``rebasing'' and ``revising,'' while often used 
interchangeably, denote different activities. The term ``rebasing'' 
means moving the base year for the structure of costs of an input price 
index (that is, in this exercise, we moved the base year cost structure 
from CY 2010 to CY 2016) without making any other major changes to the 
methodology. The term ``revising'' means changing data sources, cost

[[Page 56426]]

categories, and/or price proxies used in the input price index.
    For this rebasing and revising, we rebased the detailed wages and 
salaries and benefits cost weights to reflect 2016 BLS Occupational 
Employment Statistics (OES) data for HHAs. The 2010-based home health 
market basket used 2010 BLS OES data for HHAs. We also proposed to 
break out the All Other (residual) cost category weight into more 
detailed cost categories, based on the 2007 Benchmark U.S. Department 
of Commerce, Bureau of Economic Analysis (BEA) Input-Output (I-O) Table 
for HHAs. The 2010-based home health market basket used the 2002 I-O 
data. Finally, due to its small weight, we proposed to eliminate the 
cost category `Postage' and include these expenses in the `All Other 
Services' cost weight.
    Comment: Another commenter supported the rebasing of the home 
health market basket.
    Response: We appreciate the commenter's support.
c. Derivation of the 2016-Based Home Health Market Basket Cost Weights
    The major cost weights for this revised and rebased home health 
market basket are derived from the Medicare cost reports (MCR; CMS Form 
1728-94) data for freestanding HHAs whose cost reporting period began 
on or after October 1, 2015 and before October 1, 2016. Of the 2016 
Medicare cost reports for freestanding HHAs, approximately 84 percent 
of the reports had a begin date on January 1, 2016, approximately 6 
percent had a begin date on July 1, 2016, and approximately 4 percent 
had a begin date on October 1, 2015. Using this methodology allowed our 
sample to include HHAs with varying cost report years including, but 
not limited to, the Federal fiscal or calendar year. We referred to the 
market basket as a calendar year market basket because the base period 
for all price proxies and weights are set to CY 2016.
    We maintained our policy of using data from freestanding HHAs (77 
FR 67081), which account for over 90 percent of HHAs (82 FR 35383), 
because we have determined that they better reflect HHAs' actual cost 
structure. Expense data for hospital-based HHAs can be affected by the 
allocation of overhead costs over the entire institution.
    We derived eight major expense categories (Wages and Salaries, 
Benefits, Contract Labor, Transportation, Professional Liability 
Insurance (PLI), Fixed Capital, Movable Capital, and a residual ``All 
Other'') from the 2016 Medicare HHA cost reports. Due to its small 
weight, we eliminated the cost category `Postage' and included these 
expenses in the ``All Other (residual)'' cost weight. These major 
expense categories are based on those cost centers that are 
reimbursable under the HHA PPS, specifically Skilled Nursing Care, 
Physical Therapy, Occupational Therapy, Speech Pathology, Medical 
Social Services, Home Health Aide, and Supplies. These are the same 
cost centers that were used in the 2014 base payment rebasing (78 FR 
72276), which are described in the Abt Associates Inc. June 2013, 
Technical Paper, ``Analyses In Support of Rebasing and Updating 
Medicare Home Health Payment Rates'' (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Analyses-in-Support-of-Rebasing-and-Updating-the-Medicare-Home-Health-Payment-Rates-Technical-Report.pdf). Total costs for the HHA PPS reimbursable 
services reflect overhead allocation. We provide detail on the 
calculations for each major expense category.
    1. Wages and Salaries: Wages and Salaries costs reflect direct 
patient care wages and salaries costs as well as wages and salaries 
costs associated with Plant Operations and Maintenance, Transportation, 
and Administrative and General. Specifically, we calculated Wages and 
Salaries by summing costs from Worksheet A, column 1, lines 3 through 
12 and subtracting line 5.03 (A&G nonreimbursable costs).
    2. Benefits: Benefits costs reflect direct patient care benefit 
costs as well as benefit costs associated with Plant Operations and 
Maintenance, Transportation, and Administrative and General. 
Specifically, we calculated Benefits by summing costs from Worksheet A, 
column 2, lines 3 through 12 and subtracting line 5.03 (A&G 
nonreimbursable costs).
    3. Direct Patient Care Contract Labor: Contract Labor costs reflect 
direct patient care contract labor. Specifically, we calculated 
Contract Labor by summing costs from Worksheet A, column 4, lines 6 
through 11.
    4. Transportation: Transportation costs reflect direct patient care 
costs as well as transportation costs associated with Capital Expenses, 
Plant Operations and Maintenance, and Administrative and General. 
Specifically, we calculated Transportation by summing costs from 
Worksheet A, column 3, lines 1 through 12 and subtracting line 5.03 
(A&G Nonreimbursable costs).
    5. Professional Liability Insurance: Professional Liability 
Insurance reflects premiums, paid losses, and self-insurance costs. 
Specifically we calculated Professional Liability Insurance by summing 
costs from Worksheet S2, lines 27.01, 27.02 and 27.03.
    6. Fixed Capital: Fixed Capital-related costs reflect the portion 
of Medicare-allowable costs reported in ``Capital Related Buildings and 
Fixtures'' (Worksheet A, column 5, line 1). We calculated this Medicare 
allowable portion by first calculating a ratio for each provider that 
reflects fixed capital costs as a percentage of HHA reimbursable 
services. Specifically this ratio was calculated as the sum of costs 
from Worksheet B, column 1, lines 6 through 12 divided by the sum of 
costs from Worksheet B, column 1, line 1 minus lines 3 through 5. This 
percentage is then applied to the sum of the costs from Worksheet A, 
column 5, line 1.
    7. Movable Capital: Movable Capital-related costs reflect the 
portion of Medicare-allowable costs reported in ``Capital Related 
Moveable Equipment'' (Worksheet A, column 5, line 2). We calculated 
this Medicare allowable portion by first calculating a ratio for each 
provider that reflects movable capital costs as a percentage of HHA 
reimbursable services. Specifically this ratio was calculated as the 
sum of costs from Worksheet B, column 2, lines 6 through 12 divided by 
the sum of costs from Worksheet B, column 2, line 2 minus lines 3 
through 5. This percentage is then applied to the sum of the costs from 
Worksheet A, column 5, line 2.
    8. All Other (residual): The ``All Other'' cost weight is a 
residual and was calculated by subtracting the major cost weight 
percentages (Wages and Salaries, Benefits, Direct Patient Care Contract 
Labor, Transportation, Professional Liability Insurance, Fixed Capital, 
and Movable Capital) from 1.
    As prescription drugs and DME are not payable under the HH PPS, we 
maintained our policy to exclude those items from the home health 
market basket. Totals within each of the major cost categories were 
edited to remove reports where the data were deemed unreasonable (for 
example, when total costs were not greater than zero). We then 
determined the proportion of total Medicare allowable costs that each 
category represents. For all of the major cost categories except the 
``residual'' All Other cost weight, we then removed those providers 
whose derived cost weights fall in the top and bottom 5 percent of 
provider-specific cost weights to ensure the removal of outliers. After 
the outliers were removed, we summed the costs for each category across 
all remaining providers. Then, we divided this by the sum of total 
Medicare allowable costs across all remaining

[[Page 56427]]

providers to obtain a cost weight for the 2016-based home health market 
basket for the given category.
    Table 7 shows the major cost categories and their respective cost 
weights as derived from the Medicare cost reports for this final rule 
with comment period.
[GRAPHIC] [TIFF OMITTED] TR13NO18.012

    The decrease in the wages and salaries cost weight of 1.2 
percentage points and the decrease in the benefits cost weight of 1.3 
percentage points is attributable to both employed compensation and 
direct patient care contract labor costs as reported on the MCR data. 
Our analysis of the MCR data shows that the decrease in the 
compensation cost weight of 2.4 percentage points (calculated by 
combining wages and salaries and benefits) from 2010 to 2016 occurred 
among for-profit, nonprofit, and government providers and among 
providers serving only rural beneficiaries, only urban beneficiaries, 
or both rural and urban beneficiaries.
    Over the 2010 to 2016 time period, the average number of FTEs per 
provider decreased considerably. This corresponds with the HHA claims 
analysis published on page 35279 of the CY 2018 proposed rule (https://www.gpo.gov/fdsys/pkg/FR-2017-07-28/pdf/2017-15825.pdf), which shows 
that the number of visits per 60-day episode has decreased from 19.8 
visits in 2010 to 17.9 visits in 2016 for Medicare PPS. Medicare visits 
account for approximately 60 percent of total visits.
    The direct patient care contract labor costs are contract labor 
costs for skilled nursing, physical therapy, occupational therapy, 
speech therapy, and home health aide cost centers. We allocated these 
direct patient care contract labor costs to the Wages and Salaries and 
Benefits cost categories based on each provider's relative proportions 
of both employee wages and salaries and employee benefits costs. For 
example, the direct patient care contract labor costs that are 
allocated to wages and salaries is equal to: (1) The employee wages and 
salaries costs as a percent of the sum of employee wages and salaries 
costs and employee benefits costs times; and (2) direct patient care 
contract labor costs. Nondirect patient care contract labor costs (such 
as contract labor costs reported in the Administrative and General cost 
center of the MCR) are captured in the ``All Other'' residual cost 
weight and later disaggregated into more detail as described later in 
this section. This is a similar methodology that was implemented for 
the 2010-based home health market basket.
    We further divided the ``All Other'' residual cost weight estimated 
from the 2016 Medicare cost report data into more detailed cost 
categories. To divide this cost weight we used the 2007 Benchmark I-O 
``Use Tables/Before Redefinitions/Purchaser Value'' for NAICS 621600, 
Home Health Agencies, published by the BEA. These data are publicly 
available at http://www.bea.gov/industry/io_annual.htm. The BEA 
Benchmark I-O data are generally scheduled for publication every 5 
years. The most recent data available at the time of rebasing was for 
2007. The 2007 Benchmark I-O data are derived from the 2007 Economic 
Census and are the building blocks for BEA's economic accounts. 
Therefore, they represent the most comprehensive and complete set of 
data on the economic processes or mechanisms by which output is 
produced and distributed.\8\ Besides Benchmark I-O estimates, BEA also 
produces Annual I-O estimates. While based on a similar methodology, 
the Annual I-O estimates reflect less comprehensive and less detailed 
data sources and are subject to revision when benchmark data become 
available. Instead of using the less detailed Annual I-O data, we 
inflated the detailed 2007 Benchmark I-O data forward to 2016 by 
applying the annual price changes from the respective price proxies to 
the appropriate market basket cost categories that are obtained from 
the 2007 Benchmark I-O data. We repeated this practice for each year. 
Then, we calculated the cost shares that each cost category represents 
of the 2007 data inflated to 2016. These resulting 2016 cost shares 
were applied to the ``All Other'' residual cost weight to obtain the 
detailed cost weights for the 2016-based home health market basket. For 
example, the cost for Operations and Maintenance represents 8.0 percent 
of the sum of the ``All Other'' 2007 Benchmark I-O HHA Expenditures 
inflated to 2016. Therefore, the Operations and Maintenance cost weight 
represents 8.0 percent of the 2016-based home health market basket's 
``All Other'' cost category (19.0 percent), yielding an Operations and 
Maintenance cost weight of 1.5 percent in the 2016-based home health 
market basket (0.080 x 19.0 percent = 1.5 percent). For the 2010-based 
home health market basket, we used the same methodology utilizing the 
2002 Benchmark I-O data (aged to 2010).
---------------------------------------------------------------------------

    \8\ http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.
---------------------------------------------------------------------------

    Using this methodology, we derived nine detailed cost categories 
from the 2016-based home health market basket ``All Other'' residual 
cost weight (19.0 percent). These categories are: (1) Operations and 
Maintenance; (2) Administrative Support; (3) Financial Services; (4) 
Medical Supplies; (5) Rubber and Plastics; (6) Telephone; (7) 
Professional Fees; (8) Other Products; and (9) Other Services. The 
2010-based home health market basket included a

[[Page 56428]]

separate cost category for Postage; however, due to its small weight 
for the 2016-based home health market basket, we proposed to eliminate 
the stand-alone cost category for Postage and include these expenses in 
the Other Services cost category.
    Table 8 lists the final 2016-based home health market basket cost 
categories, cost weights, and price proxies.
[GRAPHIC] [TIFF OMITTED] TR13NO18.013

    We received no comments on the derivation of the 2016-based Home 
Health market basket cost categories and weights and therefore are 
finalizing the categories and weights without modification.
d. 2016-Based Home Health Market Basket Price Proxies
    After we computed the CY 2016 cost category weights for the rebased 
home health market basket, we selected the most appropriate wage and 
price indexes to proxy the rate of change for each expenditure 
category. With the exception of the price index for Professional 
Liability Insurance costs, the price proxies are based on Bureau of 
Labor Statistics (BLS) data and are grouped into one of the following 
BLS categories:
     Employment Cost Indexes: Employment Cost Indexes (ECIs) 
measure the rate of change in employee wage rates and employer costs 
for employee benefits per hour worked. These indexes are fixed-weight 
indexes and strictly measure the change in wage rates and employee 
benefits per hour. They are not affected by shifts in skill mix. ECIs 
are superior to average hourly earnings as price proxies for input 
price indexes for two reasons: (a) They measure pure price change; and 
(b) they are available by occupational groups, not just by industry.
     Consumer Price Indexes: Consumer Price Indexes (CPIs) 
measure change in the prices of final goods and services bought by the 
typical consumer. Consumer price indexes are used when the expenditure 
is more similar to that of a purchase at the retail level rather than 
at the wholesale level, or if no appropriate Producer Price Indexes 
(PPIs) were available.
     Producer Price Indexes: PPIs measures average changes in 
prices received by domestic producers for their goods and services. 
PPIs are used to measure price changes for goods sold in other than 
retail markets. For example, a PPI for movable equipment is used rather 
than a CPI for equipment. PPIs in some cases are preferable price 
proxies for goods that HHAs purchase at wholesale levels. These fixed-
weight indexes are a measure of price change at the producer or at the 
intermediate stage of production.
    We evaluated the price proxies using the criteria of reliability, 
timeliness, availability, and relevance. Reliability indicates that the 
index is based on valid statistical methods and has low sampling 
variability. Widely accepted statistical methods ensure that the data 
were collected and aggregated in way that can be replicated. Low 
sampling variability is desirable because it indicates that sample 
reflects the typical members of the population. (Sampling variability 
is variation that occurs by chance because a sample was surveyed rather 
than the entire population.) Timeliness implies that the proxy is 
published regularly, preferably at least once a quarter. The market 
baskets are

[[Page 56429]]

updated quarterly and therefore it is important the underlying price 
proxies be up-to-date, reflecting the most recent data available. We 
believe that using proxies that are published regularly helps ensure 
that we are using the most recent data available to update the market 
basket. We strive to use publications that are disseminated frequently 
because we believe that this is an optimal way to stay abreast of the 
most current data available. Availability means that the proxy is 
publicly available. We prefer that our proxies are publicly available 
because this would help ensure that our market basket updates are as 
transparent to the public as possible. In addition, this enables the 
public to be able to obtain the price proxy data on a regular basis. 
Finally, relevance means that the proxy is applicable and 
representative of the cost category weight to which it is applied. The 
CPIs, PPIs, and ECIs selected for use in the HH market basket meet 
these criteria. Therefore, we believe that they continue to be the best 
measure of price changes for the cost categories to which they would be 
applied.
    As part of the revising and rebasing of the home health market 
basket, we proposed to rebase the home health blended Wages and 
Salaries index and the home health blended Benefits index. We proposed 
to use these blended indexes as price proxies for the Wages and 
Salaries and the Benefits portions of the proposed 2016-based home 
health market basket, as we did in the 2010-based home health market 
basket. A more detailed discussion is provided in this rule.
     Wages and Salaries: For measuring price growth in the 
2016-based home health market basket, we proposed to apply six price 
proxies to six occupational subcategories within the Wages and Salaries 
component, which would reflect the HHA occupational mix. This is the 
same approach used for the 2010-based index. We used a blended wage 
proxy because there is not a published wage proxy specific to the home 
health industry.
    We proposed to continue to use the National Industry-Specific 
Occupational Employment and Wage estimates for North American 
Industrial Classification System (NAICS) 621600, Home Health Care 
Services, published by the BLS Office of Occupational Employment 
Statistics (OES) as the data source for the cost shares of the home 
health blended wage and benefits proxy. This is the same data source 
that was used for the 2010-based HHA blended wage and benefit proxies; 
however, we proposed to use the May 2016 estimates in place of the May 
2010 estimates. Detailed information on the methodology for the 
national industry-specific occupational employment and wage estimates 
survey can be found at http://www.bls.gov/oes/current/oes_tec.htm.
    The needed data on HHA expenditures for the six occupational 
subcategories (Health-Related Professional and Technical, Non Health-
Related Professional and Technical, Management, Administrative, Health 
and Social Assistance Service, and Other Service Workers) for the wages 
and salaries component were tabulated from the May 2016 OES data for 
NAICS 621600, Home Health Care Services. Table 9 compares the 2016 
occupational assignments to the 2010 occupational assignments of the 
six CMS designated subcategories. If an OES occupational classification 
does not exist in the 2010 or 2016 data we use ``n/a.''
BILLING CODE 4120-01-P

[[Page 56430]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.014


[[Page 56431]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.015

    Total expenditures by occupation were calculated by taking the OES 
number of employees multiplied by the OES annual average salary for 
each subcategory, and then calculating the proportion of total wage 
costs that each

[[Page 56432]]

subcategory represents. The proportions listed in Table 10 represent 
the Wages and Salaries blend weights.
[GRAPHIC] [TIFF OMITTED] TR13NO18.016

    A comparison of the yearly changes from CY 2016 to CY 2019 for the 
2010-based home health Wages and Salaries blend and the 2016-based home 
health Wages and Salaries blend is shown in Table 11. The annual 
increases in the two price proxies are the same when rounded to one 
decimal place.
[GRAPHIC] [TIFF OMITTED] TR13NO18.017

     Benefits: For measuring Benefits price growth in the 2016-
based home health market basket, we proposed to apply applicable price 
proxies to the six occupational subcategories that are used for the 
Wages and Salaries blend. The six categories in Table 12 are the same 
as those in the 2010-based home health market basket and include the 
same occupational mix as listed in Table 12.

[[Page 56433]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.018

    There is no available data source that exists for benefit 
expenditures by occupation for the home health industry. Thus, to 
construct weights for the home health benefits blend we calculated the 
ratio of benefits to wages and salaries for CY 2016 for the six ECI 
series we used in the blended `wages and salaries' and `benefits' 
indexes. To derive the relevant benefits weight, we applied the 
benefit-to-wage ratios to each of the six occupational subcategories 
from the 2016 OES wage and salary weights, and normalized. For example, 
the ratio of benefits to wages from the 2016 home health wages and 
salaries blend and the benefits blend for the management category is 
0.984. We applied this ratio to the 2016 OES weight for wages and 
salaries for management, 7.6 percent, and then normalized those weights 
relative to the other 5 benefit occupational categories to obtain a 
benefit weight for management of 7.3 percent.
    A comparison of the yearly changes from CY 2016 to CY 2019 for the 
2010-based home health Benefits blend and the 2016-based home health 
Benefits blend is shown in Table 13. The annual increases in the two 
price proxies are the same when rounded to one decimal place.
[GRAPHIC] [TIFF OMITTED] TR13NO18.019

     Operations and Maintenance: We proposed to use CPI U.S. 
city average for Fuel and utilities (BLS series code #CUUR0000SAH2) to 
measure price growth of this cost category. The same proxy was used for 
the 2010-based home health market basket.
     Professional Liability Insurance: We proposed to use the 
CMS Physician Professional Liability Insurance price index to measure 
price growth of this cost category. The same proxy was used for the 
2010-based home health market basket.
    To accurately reflect the price changes associated with physician 
PLI, each year we collect PLI premium data for physicians from a 
representative sample of commercial carriers and publically available 
rate filings as maintained by each State's Association of Insurance 
Commissioners. As we require for our other price proxies, the PLI price 
proxy is intended to reflect the pure price change associated with this 
particular cost category. Thus, the level of liability coverage is held 
constant from year to year. To accomplish this, we obtain premium 
information from a sample of commercial carriers for a fixed level of 
coverage, currently $1 million per occurrence and a $3 million annual 
limit. This information is collected for every State by physician 
specialty and risk class. Finally, the State-level, physician-specialty 
data are aggregated to compute a national total, using counts of 
physicians by State and specialty as provided in the American Medical 
Association (AMA) publication, Physician Characteristics and 
Distribution in the U.S.
     Administrative and Support: We proposed to use the ECI for 
Total compensation for Private industry workers in Office and 
administrative support (BLS series code #CIU2010000220000I) to measure 
price growth of this cost category. The same proxy was used for the 
2010-based home health market basket.
     Financial Services: We proposed to use the ECI for Total 
compensation for Private industry workers in Financial activities (BLS 
series code #CIU201520A000000I) to measure price growth of this cost 
category. The same proxy was used for the 2010-based home health market 
basket.
     Medical Supplies: We proposed to use the PPI Commodity 
data for Miscellaneous products-Medical, surgical & personal aid 
devices (BLS series code #WPU156) to measure price growth of this cost 
category. The same

[[Page 56434]]

proxy was used for the 2010-based home health market basket.
     Rubber and Plastics: We proposed to use the PPI Commodity 
data for Rubber and plastic products (BLS series code #WPU07) to 
measure price growth of this cost category. The same proxy was used for 
the 2010-based home health market basket.
     Telephone: We proposed to use CPI U.S. city average for 
Telephone services (BLS series code #CUUR0000SEED) to measure price 
growth of this cost category. The same proxy was used for the 2010-
based home health market basket.
     Professional Fees: We proposed to use the ECI for Total 
compensation for Private industry workers in Professional and related 
(BLS series code #CIS2010000120000I) to measure price growth of this 
category. The same proxy was used for the 2010-based home health market 
basket.
     Other Products: We proposed to use the PPI Commodity data 
for Final demand-Finished goods less foods and energy (BLS series code 
#WPUFD4131) to measure price growth of this category. The same proxy 
was used for the 2010-based home health market basket.
     Other Services: We proposed to use the ECI for Total 
compensation for Private industry workers in Service occupations (BLS 
series code #CIU2010000300000I) to measure price growth of this 
category. The same proxy was used for the 2010-based home health market 
basket.
     Transportation: We proposed to use the CPI U.S. city 
average for Transportation (BLS series code #CUUR0000SAT) to measure 
price growth of this category. The same proxy was used for the 2010-
based home health market basket.
     Fixed capital: We proposed to use the CPI U.S. city 
average for Owners' equivalent rent of residences (BLS series code 
#CUUS0000SEHC) to measure price growth of this cost category. The same 
proxy was used for the 2010-based home health market basket.
     Movable Capital: We proposed to use the PPI Commodity data 
for Machinery and equipment (BLS series code #WPU11) to measure price 
growth of this cost category. The same proxy was used for the 2010-
based home health market basket.
    Comment: Several commenters stated they do not believe the CY 2019 
home health market basket adequately reflects compensation pressures 
faced by home health providers. A commenter recommended that CMS build 
into the 2019 market basket update an increase to reflect general 
health care wage increases.
    Response: We believe the CY 2019 market basket update of 3.0 
percent reflects the expected compensation price increases that home 
health agencies will face in CY 2019. The compensation component of the 
2016-based Home Health market basket is 76.1 percent. The weight for 
the ``Wages and Salaries'' cost category is 65.1 percent and the weight 
for the ``Benefits'' cost category is 10.9 percent. Each of these two 
respective cost categories are proxied by price indices that reflect 
the occupational mix of home health staff for the following categories: 
Health-related professional and technical; non health-related 
professional and technical; management; administrative; health and 
social assistance services; and other service occupations. Full details 
on these price indices can be found in the CY 2019 HH PPS proposed rule 
(83 FR 32364 through 32366). For CY 2019, the estimated ``Wages and 
Salaries'' inflation is 3.2 percent and the estimated ``Benefits'' 
inflation is 3.0 percent. We believe the CY 2019 market basket update 
adequately reflects these projected price increases associated with 
wage increases specific to the health and non-health occupations used 
by the home health industry.
e. Rebasing Results
    After consideration of public comments, we are finalizing the 
proposed 2016-based home health market basket without modification. A 
comparison of the yearly changes from CY 2014 to CY 2021 for the 2010-
based home health market basket and the final 2016-based home health 
market basket is shown in Table 14.
[GRAPHIC] [TIFF OMITTED] TR13NO18.020

    Table 14 shows that the forecasted rate of growth for CY 2019 for 
the 2016-based home health market basket is 3.0 percent, the same rate 
of growth as estimated using the 2010-based home health market basket; 
other forecasted years also show a similar increase. Similarly, the 
historical estimates of the growth in the 2016-based and 2010-based 
home health market basket are the same except for CY 2015 where the

[[Page 56435]]

2010-based home health market basket is 0.1 percentage point higher.
    The growth rates in Table 14 are based upon IHS Global Inc.'s (IGI) 
3rd quarter 2018 forecast. IGI is a nationally recognized economic and 
financial forecasting firm that contracts with CMS to forecast the 
components of the market baskets. We noted in the proposed rule that if 
more recent data were subsequently available (for example, a more 
recent estimate of the market basket), we would use such data to 
determine the market basket increases in the final rule. In that 
proposed rule the forecasted rate of growth for CY 2019, based on IGI's 
1st quarter 2018 forecast, for the 2016-based home health market basket 
was 2.8 percent (83 FR 32368).
    Comment: A commenter asked if the 2002 through 2018 increases in 
the market basket represent the percentage increases in consumer health 
care costs (defined by the commenter as insurance premiums and cost for 
services) during the same time period. The commenter further stated the 
inflationary rates used understated what the actual change to costs 
would have been during this period.
    Response: We believe the commenter may be confusing the concept of 
the CMS market basket, which is an input price index, with the concept 
of a consumer price index, which is an output price index. An input 
price index measures the change in the prices of goods and services 
bought by producers or providers as intermediate inputs. An output 
price index measures the change in the prices of goods and services 
sold as output by producers.
    The 2016-based HHA market basket, along with its predecessors such 
as the 2010-based HHA market basket, are fixed-weight indices that are 
intended to measure the input prices used in providing home health care 
services. The market basket by definition is a price index rather than 
a cost index and, therefore, only accounts for changes in prices, 
holding quantities constant. In order to reflect the changes in the mix 
of input costs over time, CMS rebases the market basket periodically to 
ensure that the index is reflecting the most up to date relative cost 
shares for specific categories of expenses. We have found that the 
relative cost shares for each category do not change substantially from 
year to year.
    The current CY 2019 market basket update factor of 3.0 percent 
reflects the projected price growth in the input costs to provide home 
health services. This forecast is based on the IHS Global Inc. (IGI) 
third quarter 2018 forecast. IGI is a nationally recognized economic 
and financial forecasting firm that contracts with CMS to forecast the 
components of the market baskets.
    We also note that according to the Medicare Payment Advisory 
Committee, Medicare home health revenue has greatly exceeded Medicare 
home health costs since PPS implementation, with the most recent 
Medicare margins for 2016 estimated to be 15.5 percent (http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch9_sec_rev_0518.pdf)
f. Labor-Related Share
    Effective for CY 2019, we revised the labor-related share to 
reflect the 2016-based home health market basket Compensation (Wages 
and Salaries plus Benefits) cost weight. The current labor-related 
share is based on the Compensation cost weight of the 2010-based home 
health market basket. Based on the 2016-based home health market 
basket, the labor-related share would be 76.1 percent and the non-
labor-related share would be 23.9 percent. The labor-related share for 
the 2010-based home health market basket was 78.535 percent and the 
non-labor-related share was 21.465 percent. As explained earlier, the 
decrease in the compensation cost weight of 2.4 percentage points is 
attributable to both employed compensation (wages and salaries and 
benefits for employees) and direct patient care contract labor costs as 
reported in the MCR data. Table 15 details the components of the labor-
related share for the 2010-based and 2016-based home health market 
baskets.
[GRAPHIC] [TIFF OMITTED] TR13NO18.021

    There are no changes to the labor-related share in this final rule 
with comment period compared to the labor related share in the proposed 
rule (83 FR 32368).
    We implemented the revision to the labor-related share of 76.1 
percent in a budget neutral manner. This proposal would be consistent 
with our policy of implementing the annual recalibration of the case-
mix weights and update of the home health wage index in a budget 
neutral manner.
    Comment: Several commenters disagreed with CMS' proposal to reduce 
the labor related share, because such a change could result in less 
care for patients.
    Response: The labor related share is composed of the Wages & 
Salaries and Benefits cost weights from the 2016-based home health 
market basket. These cost weights were calculated using the 2016 
Medicare cost report data (form CMS-1728-94), which is provided 
directly by freestanding home health agencies. The 2016 data was the 
most comprehensive data source available for determining the CY 2019 
labor-related share at the time of rulemaking. The CY 2018 labor-
related share of 78.535 percent was based on the 2010-based home health 
market basket Wages and Salaries and Benefit cost weights, which were 
calculated using the 2010 Medicare cost report data. Therefore, we 
believe the labor-related share of 76.1 percent is technically 
appropriate as it is based on more recent Medicare cost report data 
reported by home health agencies.
    Comment: Another commenter agreed with CMS' proposal to reduce the 
labor related share.

[[Page 56436]]

    Response: We appreciate the commenter's support and agree that the 
labor-related share should be reduced from 78.535 percent to 76.1 
percent as it reflects the most recent Medicare cost report data for 
home health agencies available at the time of rebasing.
    Final Decision: After consideration of public comments, based on 
the 2016-based home health market basket, we are finalizing the 
proposed labor related share of 76.1 percent and the non-labor-related 
share of 23.9 percent.
g. Multifactor Productivity
    In the CY 2015 HHA PPS final rule (79 FR 38384 through 38384), we 
finalized our methodology for calculating and applying the MFP 
adjustment. As we explained in that rule, section 1895(b)(3)(B)(vi) 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)), the market basket percentage under the HHA prospective payment 
system as described in section 1895(b)(3)(B) of the Act be annually 
adjusted by changes in economy-wide productivity. Section 
1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment to 
be equal to the 10-year moving average of change in annual economy-wide 
private nonfarm business multifactor productivity (MFP) (as projected 
by the Secretary for the 10-year period ending with the applicable 
fiscal year, calendar year, cost reporting period, or other annual 
period) (the ``MFP adjustment''). The Bureau of Labor Statistics (BLS) 
is the agency that publishes the official measure of private nonfarm 
business MFP. Please see http://www.bls.gov/mfp, to obtain the BLS 
historical published MFP data.
    Based on IHS Global Inc.'s (IGI's) 3rd quarter 2018 forecast with 
history through the 2nd quarter of 2018, the projected MFP adjustment 
(the 10-year moving average of MFP for the period ending December 31, 
2019) for CY 2019 is 0.8 percent.
    We noted in the proposed rule that if more recent data were 
subsequently available (for example, a more recent estimate of the MFP 
adjustment), we would use such data to determine the MFP adjustment in 
the final rule. For comparison purposes, the proposed MFP adjustment 
for CY 2019 was 0.7 percent (83 FR 32368), and was based on IGI's 1st 
quarter 2018 forecast.
2. CY 2019 Market Basket Update for HHAs
    Using IGI's third quarter 2018 forecast, the MFP adjustment for CY 
2019 is projected to be 0.8 percent. In accordance with section 
1895(b)(3)(B)(iii) of the Act, we proposed to base the CY 2019 market 
basket update, which is used to determine the applicable percentage 
increase for HHA payments, on the most recent estimate of the 2016-
based home health market basket. Based on IGI's third quarter 2018 
forecast with history through the second quarter of 2018, the projected 
increase of the 2016-based home health market basket for CY 2019 is 3.0 
percent. We then reduce this percentage increase by the current 
estimate of the MFP adjustment for CY 2019 of 0.8 percentage point in 
accordance with 1895(b)(3)(B)(vi) of the Act. Therefore, the current 
estimate of the CY 2019 HHA payment update is 2.2 percent (3.0 percent 
market basket update, less 0.8 percentage point MFP adjustment).
    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 2019, the home health payment 
update would be 0.2 percent (2.2 percent minus 2 percentage points).
    Comment: Several commenters agreed with CMS' proposed 2.1 percent 
payment increase.
    Response: We appreciate the commenters' support. The proposed 2.1 
percent payment increase was based on IGI Global Inc.'s first quarter 
2018 forecast of the 2016-based HHA market basket and the 10-year 
moving average of annual economy-wide private nonfarm business. As 
noted in the proposed rule, if a more recent forecast of the market 
basket and MFP was available, we would use such data to determine the 
CY 2019 market basket update and MFP adjustment in the final rule. 
Based on IHS Global Inc.'s (IGI) third quarter 2018 forecast, we 
determine a payment increase of 2.2 percent for the final update 
percentage as previously stated.
    Based on IGI's third quarter 2018 forecast, we are finalizing the 
CY 2019 HHA payment update at 2.2 percent (3.0 percent market basket 
update, less 0.8 percentage point MFP adjustment).
3. CY 2019 Home Health Wage Index
    Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the 
Secretary to provide appropriate adjustments to the proportion of the 
payment amount under the HH PPS that account for area wage differences, 
using adjustment factors that reflect the relative level of wages and 
wage-related costs applicable to the furnishing of HH services. Since 
the inception of the HH PPS, we have used inpatient hospital wage data 
in developing a wage index to be applied to HH payments. We proposed to 
continue this practice for CY 2019, as we continue to believe that, in 
the absence of HH-specific wage data that accounts for area 
differences, using inpatient hospital wage data is appropriate and 
reasonable for the HH PPS. Specifically, we proposed to continue to use 
the pre-floor, pre-reclassified hospital wage index as the wage 
adjustment to the labor portion of the HH PPS rates. For CY 2019, the 
updated wage data are for hospital cost reporting periods beginning on 
or after October 1, 2014, and before October 1, 2015 (FY 2015 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 2019 HH PPS wage index, we proposed to continue 
to use the same methodology discussed in the CY 2007 HH PPS final rule 
(71 FR 65884) to address those geographic areas in which there are no 
inpatient hospitals. For rural areas that do not have inpatient 
hospitals, we proposed to use the average wage index from all 
contiguous Core Based Statistical Areas (CBSAs) as a reasonable proxy. 
Currently, the only rural area without a hospital from which hospital 
wage data could be derived is Puerto Rico. However, for rural Puerto 
Rico, we do not apply this methodology due to the distinct economic 
circumstances that exist there (for example, due to the close proximity 
to one another of almost all of Puerto Rico's various urban and non-
urban areas, this methodology would produce a wage index for rural 
Puerto Rico that is higher than that in half of its urban areas). 
Instead, we proposed to continue to use the most recent wage index 
previously available for that area. For urban areas without inpatient 
hospitals, we use the average wage index of all urban areas within the 
state as a reasonable proxy for the wage index for that CBSA. For CY 
2019, the only urban area without inpatient hospital wage data is 
Hinesville, GA (CBSA 25980).

[[Page 56437]]

    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.\9\ The most recent OMB Bulletin (No. 18-
03) was published on April 10, 2018 and is available at: https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf. The revisions contained in OMB Bulletin No. 18-03 have no 
impact on the geographic area delineations that are used to wage adjust 
HH PPS payments.
---------------------------------------------------------------------------

    \9\ https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
---------------------------------------------------------------------------

    The following is a summary of the comments received on the proposed 
CY 2019 home health wage index and our responses:
    Comment: Several commenters shared concerns in how the wage index 
is calculated and implemented for home health agencies compared to 
other prospective payment systems within the same CBSAs. A commenter 
commented that hospitals are given the opportunity to appeal their 
annual wage index and apply for geographic reclassification while HHAs 
in the same geographic location are not given that same privilege. The 
commenter believes that this lack of parity between different health 
care sectors further exemplifies the inadequacy of CMS 'decision to 
continue to use the pre-floor, pre-reclassified hospital wage index to 
adjust home health services payment rates. They gave an example of 
Massachusetts where every hospital in the Worchester CBSA and two 
hospitals in the Providence-Bristol CBSA have been re-classified to the 
Boston CBSA, effectively increasing their wage index by approximately 9 
percent and 20 percent respectively. They further suggest that CMS use 
wage index from Critical Access Hospitals in calculating the wage index 
for HHAs to make the wage index more reflective of actual local wage 
practices.
    Response: We thank the commenters for their comments. We continue 
to believe that the regulations and statutes that govern the HH PPS do 
not provide a mechanism for allowing HHAs to seek geographic 
reclassification or to utilize the rural floor provision that exists 
for Hospital Inpatient Prospective Payment System (IPPS) hospitals. 
Section 4410(a) of the Balanced Budget Act of 1997 provides that the 
area wage index applicable to any hospital that is located in an urban 
area of a State may not be less than the area wage index applicable to 
hospitals located in rural areas in that State. This is the rural floor 
provision and it is specific to hospitals. The reclassification 
provision at section 1886(d)(10)(C)(i) of the Act states that the 
Medicare Geographic Classification Review Board shall consider the 
application of any subsection (d) hospital requesting the Secretary 
change the hospital's geographic classification for purposes of payment 
under the IPPS. This reclassification provision is only applicable to 
hospitals as defined in section 1886(d) of the Act. In addition, we do 
not believe that using hospital reclassification data would be 
appropriate as these data are specific to the requesting hospitals. We 
continue to believe that using the pre-floor, pre-reclassified hospital 
wage index as the wage adjustment to the labor portion of the HH PPS 
rates is appropriate and reasonable. Although the pre-floor, pre-
classified hospital wage index does not include data from Critical 
Access Hospitals (CAHs), we believe that it reflects the relative level 
of wages and wage-related costs applicable to providing HH services. As 
we stated in the August 1, 2003 IPPS final rule (68 FR 45397), CAHs 
represent a substantial number of hospitals with significantly 
different labor costs in many labor market areas where they exist.
    Comment: A commenter expressed concerns with CMS using CY 2015 wage 
index figures for the CY 2019 wage index since there have been shifts 
in the labor market in New York State.
    Response: As discussed in the CY 2017 HH PPS final rule (81 FR 
76721), we believe that the wage index values are reflective of the 
labor costs in each geographic area as they reflect the costs included 
on the cost reports of hospitals in those specific labor market areas. 
The wage index values are based on data submitted on the inpatient 
hospital cost reports. We utilize efficient means to ensure and review 
the accuracy of the hospital cost report data and resulting wage index. 
The home health wage index is derived from the pre-floor, pre-
reclassified hospital; wage index, which is calculated based on cost 
report data submitted from hospitals paid under the IPPS. All IPPS 
hospitals must complete the wage index survey (Worksheet S-3, Parts II 
and III) as part of their Medicare cost reports. Cost reports will be 
rejected if Worksheet S-3 is not completed. In addition, Medicare 
contractors perform desk reviews on all hospitals' Worksheet S-3 wage 
data, and we run edits on the wage data to further ensure the accuracy 
and validity of the wage data. We believe that our review processes 
result in an accurate reflection of the applicable wages for each labor 
market area. The processes and procedures describing how the inpatient 
hospital wage index is developed are discussed in the IPPS rule each 
year, with the most recent discussion provided in the FY 2019 IPPS 
final rule (83 FR 41362 through 41374 and 83 FR 41380 through 41383). 
Any provider type may submit comments on the hospital wage index during 
the annual IPPS rulemaking cycle.
    Comment: A commenter believes that the CMS decision 10 years ago to 
switch from Metropolitan Statistical Areas (MSAs) to CBSAs for the wage 
adjustment to the rates has had negative financial ramifications for 
HHAs in New York City. The commenter stated that unlike past MSA 
designations, where all of the counties in the New York City 
designation were from New York State, the 2006 CBSA wage index 
designation added Bergen, Hudson, and Passaic counties from New Jersey 
into the New York City CBSA. The commenter also noted that with the CY 
2015 final rule, CMS added three more New Jersey counties (Middlesex, 
Monmouth, and Ocean) to the CBSA used for New York City.
    Response: The MSA delineations as well as the CBSA delineations are 
determined by the Office of Management and Budget (OMB). The OMB 
reviews its Metropolitan Area definitions preceding each decennial 
census to reflect recent population changes. We believe that the OMB's 
CBSA designations reflect the most recent available geographic 
classifications and are a reasonable and appropriate way to define 
geographic areas for purposes of wage index values. Over 10 years ago, 
in our CY 2006 HH PPS final rule (70 FR 68132), we finalized the 
adoption of the revised labor market area definitions as discussed in 
the OMB Bulletin No. 03- 04 (June 6, 2003). In the December 27, 2000 
Federal Register (65 FR 82228 through 82238), the OMB announced its new 
standards for defining metropolitan and micropolitan statistical areas. 
According to that notice, the OMB defines a CBSA, beginning in 2003, as 
``a geographic entity associated with at least one core of 10,000 or 
more population, plus adjacent territory that has a high degree of 
social and economic integration with the core as

[[Page 56438]]

measured by commuting ties.'' The general concept of the CBSAs is that 
of an area containing a recognized population nucleus and adjacent 
communities that have a high degree of integration with that nucleus. 
The purpose of the standards is to provide nationally consistent 
definitions for collecting, tabulating, and publishing federal 
statistics for a set of geographic areas. CBSAs include adjacent 
counties that have a minimum of 25 percent commuting to the central 
counties of the area. This is an increase over the minimum commuting 
threshold for outlying counties applied in the previous MSA definition 
of 15 percent. Based on the OMB's current delineations, as described in 
the July 15, 2015 OMB Bulletin 15-01, the New Jersey counties of 
Bergen, Hudson, Middlesex, Monmouth, Ocean, and Passaic belong in the 
New York-Jersey City-White Plains, NY-NJ (CBSA 35614). In addition, for 
the payment systems of other provider types, such as IPPS hospitals, 
hospices, skilled nursing facilities (SNFs), inpatient rehabilitation 
facilities (IRFs), and ESRD facilities, we have used CBSAs to define 
their labor market areas for more than a decade.
    Comment: A commenter questioned the validity of the wage index 
data, especially in the case of the CBSA for Albany-Schenectady-Troy, 
noting that in the past 5 years, this CBSA has seen its wage index 
reduced 6.18 percent, going from 0.8647 in 2013 to a proposed CY 2019 
wage index of 0.8179.
    Response: As discussed in the CY 2017 HH PPS final rule (81 FR 
76721), we believe that the wage index values are reflective of the 
labor costs in each geographic area as they reflect the costs included 
on the cost reports of hospitals in those specific labor market areas. 
The area wage index measures differences in hospital wage rates among 
labor market areas and compares the area wage index of the labor market 
area to the national average hourly wage. If a hospital or labor market 
area does not keep pace with the national average hourly wage in a 
given year, then the labor market area will see a decrease in the area 
wage index during that year.
    Comment: A commenter recommended that providers meeting higher 
minimum wage standards, such as HHAs, obtain additional supplemental 
funding to better align payments with cost trends impacting providers.
    Response: Regarding minimum wage standards, we note that such 
increases will be reflected in future data used to create the hospital 
wage index to the extent that these changes to state minimum wage 
standards are reflected in increased wages to hospital staff.
    Final Decision: After considering the comments received in response 
to the CY 2019 HH PPS proposed rule, we are finalizing our proposal to 
continue to use the pre-floor, pre-reclassified hospital inpatient wage 
index as the wage adjustment to the labor portion of the HH PPS rates. 
For CY 2019, the updated wage data are for the hospital cost reporting 
periods beginning on or after October 1, 2014 and before October 1, 
2015 (FY 2015 cost report data). The final CY 2019 wage index is 
available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
4. CY 2019 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 is a national, standardized 60-day 
episode payment rate. As set forth in Sec.  484.220, we adjust the 
national, standardized 60-day episode payment rate 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. The labor-related share of the case-mix adjusted 60-day episode 
is 76.1 percent and the non-labor-related share is 23.9 percent for CY 
2019. The CY 2019 HH PPS rates use the same case-mix methodology as set 
forth in the CY 2008 HH PPS final rule with comment period (72 FR 
49762) and is adjusted as described in section III.B of this final rule 
with comment period. The following are the steps we take to compute the 
case-mix and wage-adjusted 60-day episode rate for CY 2019:
     Multiply the national 60-day episode 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, subject to 
any additional applicable adjustments.
    In accordance with section 1895(b)(3)(B) of the Act, we proposed 
the annual update of the HH PPS rates. Section 484.225 sets forth the 
specific annual percentage update methodology. In accordance with Sec.  
484.225(i), for a HHA that does not submit HH quality data, as 
specified by the Secretary, the unadjusted national prospective 60-day 
episode rate is equal to the rate for the previous calendar year 
increased by the applicable HH market basket index amount 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 the national, standardized 60-day case-mix and wage-
adjusted episode payment on a split percentage payment approach. The 
split percentage payment approach includes an initial percentage 
payment and a final percentage payment as set forth in Sec.  
484.205(b)(1) and (b)(2). We may base the initial percentage payment on 
the submission of a request for anticipated payment (RAP) and the final 
percentage payment on the submission of the claim for the episode, as 
discussed in Sec.  409.43. The claim for the episode that the HHA 
submits for the final percentage payment determines the total payment 
amount for the episode and whether we make an applicable adjustment to 
the 60-day case-mix and wage-adjusted episode payment. The end date of 
the 60-day episode as reported on the claim determines which calendar 
year rates Medicare will use to pay the claim.
    We may also adjust the 60-day case-mix and wage-adjusted episode 
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(c) and 484.230.
     A partial episode payment (PEP) adjustment as set forth in 
Sec. Sec.  484.205(d) and 484.235.
     An outlier payment as set forth in Sec. Sec.  484.205(e) 
and 484.240.
b. CY 2019 National, Standardized 60-Day Episode Payment Rate
    Section 1895(b)(3)(A)(i) of the Act requires that the 60-day 
episode base 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 2019 national, standardized 
60-day episode payment rate, we apply a wage index

[[Page 56439]]

budget neutrality factor and a case- mix budget neutrality factor 
described in section III.B of this final rule with comment period; and 
the home health payment update percentage discussed in section III.C.2. 
of this final rule with comment period.
    To calculate the wage index budget neutrality factor, we simulated 
total payments for non-LUPA episodes using the CY 2019 wage index 
(including the application of the labor-related share of 76.1 percent 
and the non-labor-related share of 23.9 percent) applied to CY 2017 
utilization (claims) data and compared it to our simulation of total 
payments for non-LUPA episodes using the CY 2018 wage index (including 
the application of the current labor-related share of 78.535 percent 
and the non-labor-related of 21.465) applied to CY 2017 utilization 
(claims) data. By dividing the total payments for non-LUPA episodes 
using the CY 2019 wage index by the total payments for non-LUPA 
episodes using the CY 2018 wage index, we obtain a wage index budget 
neutrality factor of 0.9985. We will apply the wage index budget 
neutrality factor of 0.9985 to the calculation of the CY 2019 national, 
standardized 60-day episode payment rate.
    As discussed in section III.B. of this final rule with comment 
period, to ensure the changes to the case-mix weights are implemented 
in a budget neutral manner, we proposed to apply a case-mix weight 
budget neutrality factor to the CY 2019 national, standardized 60-day 
episode payment rate. The case-mix weight budget neutrality factor is 
calculated as the ratio of total payments when CY 2019 case-mix weights 
are applied to CY 2017 utilization (claims) data to total payments when 
CY 2018 case-mix weights are applied to CY 2017 utilization data. The 
case-mix budget neutrality factor for CY 2019 is 1.0169 as described in 
section III.B. of this final rule with comment period. Next, we apply 
the payment rates by the CY 2019 home health payment update percentage 
of 2.2 percent as described in section III.C.2. of this final rule with 
comment period. The CY 2019 national, standardized 60-day episode 
payment rate is calculated in Table 16.
[GRAPHIC] [TIFF OMITTED] TR13NO18.022

    The CY 2019 national, standardized 60-day episode payment rate for 
an HHA that does not submit the required quality data is updated by the 
CY 2019 home health payment update of 2.2 percent minus 2 percentage 
points and is shown in Table 17.
[GRAPHIC] [TIFF OMITTED] TR13NO18.023

c. CY 2019 National Per-Visit Rates
    The national per-visit rates are used to pay LUPAs (episodes with 
four or fewer visits) 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 2019 national per-visit rates, we started with 
the CY 2018 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 2019 wage 
index and comparing it to simulated total payments for LUPA episodes 
using the CY 2018 wage index. By dividing the total payments for LUPA 
episodes using the CY 2019 wage index by the total payments for LUPA 
episodes using the CY 2018 wage index, we obtained a wage index budget 
neutrality factor of 0.9996. We apply the wage index budget neutrality 
factor of 0.9996 in order to

[[Page 56440]]

calculate the CY 2019 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 2019 home health payment 
update percentage of 2.2 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 2019 national per-visit rates for HHAs that submit the required 
quality data are updated by the CY 2019 HH payment update percentage of 
2.2 percent and are shown in Table 18.
[GRAPHIC] [TIFF OMITTED] TR13NO18.024

    The CY 2019 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the CY 2019 HH payment update 
percentage of 2.2 percent minus 2 percentage points and are shown in 
Table 19.
[GRAPHIC] [TIFF OMITTED] TR13NO18.025

d. Low-Utilization Payment Adjustment (LUPA) Add-On Factors
    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. For 
example, in the case of HHAs that do submit the required quality data, 
for LUPA episodes that occur as the only episode or an initial episode 
in a sequence of adjacent episodes, if the first skilled visit is SN, 
the payment for that visit will be $270.27 (1.8451 multiplied by 
$146.48), subject to area wage adjustment.
e. CY 2019 Non-Routine Medical Supply (NRS) Payment Rates
    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, I.V. 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 2019 NRS conversion factor, we updated the CY 2018 NRS 
conversion

[[Page 56441]]

factor ($53.03) by the CY 2019 home health payment update percentage of 
2.2 percent. We did not apply a standardization factor as the NRS 
payment amount calculated from the conversion factor is not wage or 
case-mix adjusted when the final claim payment amount is computed. The 
NRS conversion factor for CY 2019 is shown in Table 20.
[GRAPHIC] [TIFF OMITTED] TR13NO18.026

    Using the CY 2019 NRS conversion factor, the payment amounts for 
the six severity levels are shown in Table 21.
[GRAPHIC] [TIFF OMITTED] TR13NO18.027

    For HHAs that do not submit the required quality data, we updated 
the CY 2018 NRS conversion factor ($53.03) by the CY 2019 home health 
payment update percentage of 2.2 percent minus 2 percentage points. The 
CY 2019 NRS conversion factor for HHAs that do not submit quality data 
is shown in Table 22.
[GRAPHIC] [TIFF OMITTED] TR13NO18.028

    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 23.

[[Page 56442]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.029

    The following is a summary of the public comments received on the 
CY 2019 Annual Payment Update and our responses.
    Comment: Several commenters expressed concerns with the reduction 
in the labor-related shares suggesting such a change will result in 
less care for patients.
    Response: We thank the commenters for expressing their concerns. As 
noted in the proposed rule (83 FR 32368), the decrease in compensation 
cost weight of 2.4 percentage points is attributable to both employed 
compensation (wages and salaries and benefits for employees) and direct 
patient care contract labor costs as reported in the MCR data. The 
decreased labor-related share is implemented in a budget neutral 
manner, which is consistent with the policies for implementing the 
annual recalibration of the case-mix weights and update of the home 
health wage index in a budget neutral manner.
    Comment: A commenter stated that HHAs have received only one 
positive inflation update since 2011 and that this has left them behind 
in their ability to attract and retain medically trained personnel.
    Response: The home health market basket growth rate measures input 
price inflation associated with providing home health services. We 
disagree with the commenter that home health agencies have only 
received one positive inflation update since 2011 as the market basket 
update has been approximately 2 percent or higher annually. The table 
24 shows the home health market basket updates and productivity 
adjustments from CY 2011 to CY 2018.
[GRAPHIC] [TIFF OMITTED] TR13NO18.030

    Over the 2011 to 2018 time period, the home health market basket 
update and home health payment rates have been reduced to reflect other 
statutorily required adjustments (such as the MFP adjustment (required 
by section 1895(b)(3)(B)(vi) of the Social Security Act), and rebasing 
adjustments to the national, standardized 60-day episode payment rates 
(required under section 3131(a) of the Patient Protection and 
Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health 
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)). In 
some years, this has resulted in the 60-day episode payment rates being 
less than in prior years. The rationale and methodology regarding these 
other adjustments, along with CMS response to comments, can be found in 
prior CY HH PPS proposed and final rules.
    We would note, however, that since PPS implementation and 
particularly over the 2011 to 2016 time period, according to MedPAC, 
freestanding home health agency margins have averaged roughly 14 
percent. Furthermore, as shown in the 2016-based home health market 
basket, approximately 76 percent of home health costs are compensation 
costs; therefore, we disagree with the commenter's claims that they are 
unable to attract and retain medically trained personnel due to 
insufficient payment updates.
    Comment: While several commenters commended and supported CMS on 
recognizing the need for an increase in home health payments per 60-day 
episode, MedPAC commented that this increase is not warranted based on 
their analysis of payment adequacy.
    Response: We note that we are statutorily required to update the 
payment rates under the prospective payment system by the home health 
payment update percentage in accordance with section 1895(b)(3)(B) of 
the Act.
    Final Decision: After considering all comments received on the 
proposed payment rate update for CY 2019, we are finalizing the 
application of the wage index budget neutrality factor (which includes 
making the change in the labor-related share budget neutral), the case-
mix adjustment budget neutrality factor and the home health payment 
update percentage in updating the home health payment rates for CY 2019 
as proposed.

[[Page 56443]]

D. Rural Add-On Payments for CYs 2019 Through 2022

1. Background
    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), 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 DRA 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 Bipartisan Budget Act 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 2019 Through 2022
    Section 50208(a)(1)(D) of the BBA of 2018 adds a new subsection (b) 
to section 421 of the MMA to provide rural add-on payments for episodes 
and visits ending during CYs 2019 through 2022. It also mandates 
implementation of a new methodology for applying those payments. Unlike 
previous rural add-ons, which were applied to all rural areas 
uniformly, the extension provides 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).
    The proposed rule outlined how we categorized rural counties (or 
equivalent areas) into the three distinct categories outlined in 
section 50208 of the BBA of 2018 based on CY 2015 claims data and 2015 
data from the Medicare Beneficiary Summary File, as well as 2010 Census 
data. The rural add-on percentages and duration of rural add-on 
payments outlined in law are shown in Table 25. The HH Pricer module, 
located within CMS' claims processing system, will increase the base 
payment rates provided in Tables 16 through 23 by the appropriate rural 
add-on percentage prior to applying any case-mix and wage index 
adjustments.
[GRAPHIC] [TIFF OMITTED] TR13NO18.031

    The proposed rule further described the provisions of section 
50208(a)(2) of the Bipartisan Budget Act of 2018, which amended section 
1895(c) of the Act by adding a new requirement set out at section 
1895(c)(3) of the Act. This requirement states that no claim for home 
health services may be paid unless ``in the case of home health 
services furnished on or after January 1, 2019, the claim contains the 
code for the county (or equivalent area) in which the home health 
service was furnished.'' This information will be necessary in order to 
calculate the rural add-on payments. We proposed that HHAs enter the 
FIPS state and county code, rather than the SSA state and county code, 
on the claim.
    The data used to categorize each county or equivalent area is 
available in the Downloads section associated with the publication of 
the proposed rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices-Items/CMS-1689-P.html. In addition, an Excel 
file containing the rural county or equivalent area names, their FIPS 
state and county codes, and their designation into one of the three 
rural add-on categories is available for download.
    The following is a summary of the public comments received on the 
proposal for Rural Add-on Payments for CYs 2019 through 2022 and our 
responses:
    Comment: A commenter stated that they do not object to the 
methodology used by CMS in implementing the rural add-on payments for 
CYs 2019-CY 2022, but they request that CMS ask Congress to modify and 
reauthorize the three percent rural safeguard for all rural counties to 
ensure access to home health services by Medicare beneficiaries in 
rural areas. Some commenters suggested that the cost reports indicate 
FFS margins are at 5 percent or below, which they suggested reflects 
the high cost of travel in rural areas and the cost of staffing of 
visits into rural areas. The commenters indicated that many margins 
included

[[Page 56444]]

the 3 percent rural add-on, thereby further justifying the continuation 
of the rural-add on payments. Several commenters expressed concern with 
the reduction and elimination of the rural add-on payments suggesting 
that without the payments it would make caring for home health patients 
in rural areas a challenge. Many urged CMS to continue providing rural 
add-on payments after 2022 so that beneficiaries in rural communities 
continue to have access to home health services. Several commenters 
suggested that CMS establish a workgroup to examine rural costs and how 
best to address those costs with an add-on payment.
    Response: Section 421(a) of the MMA, as amended by section 50208 of 
the BBA of 2018, provides a 3 percent rural add-on for HH services 
provided in a rural area for episodes and visits ending before January 
1, 2019. Section 421(b)(1) of the MMA, as amended by section 50208 of 
the BBA of 2018, stipulates the percentage of rural add-on payments by 
rural county (or equivalent area) classification for episodes and 
visits ending during CYs 2019 through 2022, as provided in Table 25. As 
these are statutory requirements, we do not have the authority to 
provide a 3 percent rural add-on for episodes and visits ending on or 
after January 1, 2019 across all rural areas, or to extend rural add-on 
payments beyond the duration of the period for which rural add-on 
payment are in place under section 421(b)(1) of the MMA. However, we 
plan to continue to monitor the costs associated with providing home 
health care in rural versus urban areas.
    Comment: MedPAC stated that the rural payment add-on policy for 
2019 is an improvement that better targets Medicare's scarce resources. 
They further stated that average utilization is not significantly 
different between urban and rural areas, but there is some variation 
around this average, with high-and-low use areas found in counties. 
They commented that the proposed policy targets payments to areas with 
lower population density and limits payments to rural areas with higher 
utilization.
    Response: We thank MedPAC for their comments.
    Comment: A commenter recommended that CMS research the impact the 
rural add-on extension will have on low population density areas 
particularly with the proposal to move to the cost per minute plus non-
routine supplies approach in estimating resource use under the PDGM.
    Response: We thank the commenter for this suggestion. We will 
continue monitoring the impacts due to policy changes, including the 
changes in rural add-on payments for CYs 2019 through 2022, and will 
provide the industry with periodic updates on our analysis in 
rulemaking and/or announcements on the HHA Center web page at: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
    Comment: Several commenters stated that a HHA may have demographic 
changes within the four-year period and that they should be able to 
retract and change their category of rural counties or equivalent areas 
for the HH rural add-on payment.
    Response: Section 421(b)(2)(a) of the MMA provides that the 
Secretary shall make a determination only for a single time as to which 
category under sections 421(b)(1)(A) (the ``High utilization'' 
category), 421(b)(1)(B) (the ``Low population density'' category), or 
421(b)(1)(C) (the ``All other'' category) of the MMA that a rural 
county or equivalent area is classified into, and that the 
determination applies for the duration of the period for which rural 
add-on payments are in place under section 421(b) of the MMA. As these 
are statutory requirements, we do not have the authority to allow the 
changes to rural county or equivalent area classifications suggested by 
the commenters.
    Final Decision: We are finalizing the policies for the provision of 
rural add-on payments for CY 2019 through CY 2022 in accordance with 
section 50208 of the BBA of 2018, which adds a new subsection to 
section to 421 of the MMA. This includes finalizing the designations of 
rural counties (or equivalent areas) into their respective categories 
as outlined in the excel files published on the HHA center web page in 
conjunction with the CY 2019 HH PPS proposed rule: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices-Items/CMS-1689-P.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending.

E. Payments for High-Cost Outliers Under the HH PPS

1. Background
    Section 1895(b)(5) of the Act allows for the provision of an 
addition or adjustment to the home health payment amount otherwise made 
in the case of outliers because of unusual variations in the type or 
amount of medically necessary care. Under the HH PPS, outlier payments 
are made for episodes whose estimated costs exceed a threshold amount 
for each Home Health Resource Group (HHRG). The episode's estimated 
cost was established as the sum of the national wage-adjusted per-visit 
payment amounts delivered during the episode. The outlier threshold for 
each case-mix group or Partial Episode Payment (PEP) adjustment is 
defined as the 60-day episode payment or PEP adjustment for that group 
plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS, 
the FDL amount is calculated by multiplying the HH FDL ratio by a 
case's wage-adjusted national, standardized 60-day episode payment 
rate, which yields an FDL dollar amount for the case. The outlier 
threshold amount is the sum of the wage and case-mix adjusted PPS 
episode amount and wage-adjusted FDL amount. The outlier payment is 
defined to be a proportion of the wage-adjusted estimated cost beyond 
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, and required the Secretary to 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 redesignating 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 at 10 percent.
    As such, beginning in CY 2011, we reduce payment rates by 5 percent 
and target up to 2.5 percent of total estimated HH PPS payments to be 
paid as outliers. To do so, we first returned the 2.5 percent held for 
the target CY 2010 outlier pool to the national, standardized 60-day 
episode rates, the national per visit rates, the LUPA add-on payment 
amount, and the NRS conversion factor for CY 2010. We then reduced the 
rates by 5 percent as required by section 1895(b)(3)(C) of the Act, as 
amended by section 3131(b)(1) of the Affordable Care Act. For CY 2011 
and subsequent calendar years we target up to 2.5 percent of estimated 
total payments to be paid as outlier

[[Page 56445]]

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 2019 in the 
rate update change request, which is issued after the publication of 
the CY 2019 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.
2. Fixed Dollar Loss (FDL) Ratio
    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 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. Alternatively, a lower FDL ratio means that more episodes can 
qualify for outlier payments, but outlier payments per episode 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 
above the outlier threshold amount.
    Simulations based on CY 2015 claims data (as of June 30, 2016) 
completed for the CY 2017 HH PPS final rule showed that outlier 
payments were estimated to represent approximately 2.84 percent of 
total HH PPS payments in CY 2017, and as such, we raised the FDL ratio 
from 0.45 to 0.55. We stated that raising the FDL ratio to 0.55, while 
maintaining a loss-sharing ratio of 0.80, struck an effective balance 
of compensating for high-cost episodes while still meeting the 
statutory requirement to target up to, but no more than, 2.5 percent of 
total payments as outlier payments (81 FR 76726). The national, 
standardized 60-day episode payment amount is multiplied by the FDL 
ratio. That amount is wage-adjusted to derive the wage-adjusted FDL 
amount, which is added to the case-mix and wage-adjusted 60-day episode 
payment amount to determine the outlier threshold amount that costs 
have to exceed before Medicare would pay 80 percent of the additional 
estimated costs.
    In the CY 2019 proposed rule, we simulated payments using 
preliminary CY 2017 claims data (as of March 2, 2018) and the CY 2018 
HH PPS payment rates (82 FR 51676), and estimated that outlier payments 
in CY 2018 would comprise 2.30 percent of total payments and 
approximately 2.32 percent of total HH PPS payments in CY 2019. Our 
simulations showed that the FDL ratio would need to be changed from 
0.55 to 0.51 to pay up to, but no more than, 2.5 percent of total 
payments as outlier payments in CY 2019.
    Given the statutory requirement that total outlier payments not 
exceed 2.5 percent of the total payments estimated to be made based 
under the HH PPS, in the CY 2019 proposed rule, we proposed to lower 
the FDL ratio for CY 2019 from 0.55 to 0.51 to better approximate the 
2.5 percent statutory maximum. However, we noted that we were not 
proposing a change to the loss-sharing ratio (0.80) for the HH PPS to 
remain consistent with payment for high-cost outliers in other Medicare 
payment systems (for example, IRF PPS, IPPS, etc.).
    Using updated CY 2017 claims data (as of June 30, 2018) and the 
final CY 2019 payment rates presented in section III.C of this final 
rule with comment period, we estimate that outlier payments would 
continue to constitute approximately 2.47 percent of total HH PPS 
payments in CY 2019 under the current outlier methodology. Given the 
statutory requirement to target up to, but no more than, 2.5 percent of 
total payments as outlier payments, we believe that modifying the FDL 
ratio from 0.55 to 0.51 with a loss-sharing ratio of 0.80 is 
appropriate given the percentage of outlier payments projected for CY 
2019.
3. Home Health Outlier Payments: Clinical Examples
    In the CY 2019 HH PPS proposed rule, we also described clinical 
examples of how care for a patient with ALS could qualify for an 
additional outlier payment, which would serve to offset unusually high 
costs associated with providing home health to a patient with unusual 
variations in the amount of medically necessary care. (83 FR 32340).
    The following is a summary of the comments received on outlier 
payments under the HH PPS and our responses.
    Comment: Several commenters recommended that CMS conduct a more 
detailed analysis to determine whether the total cap of 2.5 percent of 
total payments as outlier payments is adequate or whether it needs to 
be increased for future years, particularly given the expected change 
in Medicare beneficiary demographics anticipated in the coming years.
    Response: As established in section 1895(b)(5) of the Act, both the 
2.5 percent target of outlier payments to total home health payments 
and the 10-percent cap on outlier payments at the home health agency 
level are statutory

[[Page 56446]]

requirements. Therefore, we do not have the authority to adjust or 
eliminate the 10-percent cap or increase the 2.5-percent target amount. 
However, we will continue to evaluate for the appropriateness of those 
elements of the outlier policy that may be modified, including the FDL 
and the loss-sharing ratio. We note that other Medicare payment systems 
with outlier payments, such as the IRF PPS and IPPS, annually reassess 
the fixed-loss cost outlier threshold amount. Adjusting the outlier 
threshold amount in order to target the statutorily required percentage 
of total payments as outlier payments is standard practice.
    Comment: A commenter recommended that CMS eliminate outlier 
payments in their entirety.
    Response: We believe that section 1895(b)(5)(A) of the Act allows 
the Secretary the discretion as to whether or not to have an outlier 
policy under the HH PPS. However, we also believe that outlier payments 
are beneficial in that they help mitigate the incentive for HHAs to 
avoid patients that may have episodes of care that result in unusual 
variations in the type or amount of medically necessary care. The 
outlier system is meant to help address extra costs associated with 
extra, and potentially unpredictable, medically necessary care. We note 
that we plan to continue evaluating whether or not an outlier policy 
remains appropriate as well as ways to maintain an outlier policy for 
episodes that incur unusually high costs due to patient care needs.
    Comment: Several commenters suggested that we include the cost of 
supplies in our outlier calculations as the inclusion of the cost of 
supplies as opposed to the estimated costs would yield more accurate 
payment totals to be used for determination of outlier payments.
    Response: We appreciate the commenters' suggestion regarding the 
inclusion of supplies in the outlier calculations. In order to 
incorporate supply costs into the outlier calculation, significant 
systems modifications would be required. However, we will consider 
whether to add supply costs to the outlier calculations and evaluate 
whether such a policy change is appropriate for future rulemaking.
    Comment: A commenter expressed concerns about the per-unit outlier 
approach established in 2017, stating that the assumptions regarding 
this policy change were not accurate, thereby leading to difficulties 
in the HHA community. The commenter further suggested that if the 
outlier provision is to continue for CY2019, then we should revert to 
the per-visit approach.
    Response: We appreciate the commenter's feedback regarding the 
revisions to the methodology utilized to calculate outliers in the HH 
PPS. We maintain that the transition to the per-unit approach advanced 
our objectives of better aligning payment with the costs of providing 
care, but we will continue to monitor the impact of this policy change 
as more recent data become available, and we may propose to modify the 
outlier policy approaches as needed in the future.
    Comment: Several commenters expressed support for the clinical 
examples provided in the CY 2019 proposed rule and appreciated the 
descriptions of how an outlier payment may be made for the provision of 
care for patients living with significant longer-term and debilitating 
conditions, including ALS.
    Response: We appreciate the commenters' support and hope that the 
examples illustrating how HHAs could be paid by Medicare for providing 
care to patients with higher resource use in their homes served to 
highlight that a patient's condition does not need to improve for home 
health services to be covered by Medicare. We likewise hope that the 
examples helped to provide a better understanding of Medicare coverage 
policies and how outlier payments promote access to home health 
services for such patients under the HH PPS.
    Comment: A commenter requested that we identify specific diseases, 
like ALS, that the commenter asserts are systematically underpaid and 
exclude outlier payments for such patients from the fixed dollar loss 
amount and cost sharing percentage up to the full reasonable cost of 
care at those agencies accepting them for care. Additionally, the 
commenter suggested that we separately identify those agencies in each 
area who agree to accept high cost ALS patients under the 
aforementioned exception. Moreover, the commenter suggested that we 
undertake a demonstration to test whether an alternative payment 
mechanism under the home health benefit similar to Disproportionate 
Share Payments or a Special Needs Plans would provide full access to 
home health care for ALS and similar patients as well as a 
demonstration of a bridge program that is a combination of the 
appropriate features of the Medicare home health and hospice benefits 
that the commenter asserts would constitute a cost-effective 
alternative to the use of both benefits and assure access to patients 
needing ``Advanced Disease Management'' (ADM), blending curative 
treatment approaches of home health and the palliative care benefits of 
hospice in a manner that allows a seamless transition for persons whose 
disease process is highly likely to advance and result in death within 
a two-year period.
    Response: We appreciate the commenter's feedback regarding the 
suggested modifications to the home health outlier calculation as well 
as the recommendation for possible demonstrations related to home 
health cases that may qualify for an outlier payment. We maintain that 
section 1895(b)(5)(A) of the Act allows the Secretary the discretion as 
to whether or not to have an outlier policy under the HH PPS and we 
believe that outlier payments are beneficial in that they help mitigate 
the incentive for HHAs to avoid patients that may have episodes of care 
that result in unusual variations in the type or amount of medically 
necessary care. The outlier system is meant to help address extra costs 
associated with extra, and potentially unpredictable, medically 
necessary care. The outlier calculation is based upon total payments 
within the HH PPS and we do not believe it would be appropriate to 
exclude certain cases from the overall calculation or to make 
additional payments to certain providers that offer services to home 
health beneficiaries with a certain clinical profile. Regarding the 
possibility of a demonstration for those beneficiaries with high 
resource use, we will consider the comments as we develop new models 
through the Center for Medicare and Medicaid Innovation. We note that 
we would need to determine whether such a model would meet the 
statutory requirements to be expected to reduce Medicare expenditures 
and preserve or enhance the quality of care for beneficiaries.
    Final Decision: We are finalizing the change to the FDL ratio or 
loss sharing ratio for CY 2019. We are establishing an FDL ratio of 
0.51 with a loss-sharing ratio of 0.80 for CY 2019. We will continue to 
monitor outlier payments and continue to explore ways to maintain an 
outlier policy for episodes that incur unusually high costs.

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

1. Summary of the Proposed PDGM Model, Data, and File Construction
    To better align payment with patient care needs and better ensure 
that clinically complex and ill beneficiaries have adequate access to 
home health care, we proposed case-mix methodology refinements through 
the

[[Page 56447]]

implementation of the Patient-Driven Groupings Model (PDGM). We 
proposed to implement the PDGM for home health periods of care 
beginning on or after January 1, 2020. 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.
    Costs during an episode/period of care are estimated based on the 
concept of resource use, which measures the costs associated with 
visits performed during a home health episode/period. For the current 
HH PPS case-mix weights, we use Wage Weighted Minutes of Care (WWMC), 
which uses data from the Bureau of Labor Statistics (BLS) reflecting 
the Home Health Care Service Industry. For the PDGM, we proposed 
shifting to a Cost-Per-Minute plus Non-Routine Supplies (CPM + NRS) 
approach, which uses information from the Medicare Cost Report. The CPM 
+ NRS approach incorporates a wider variety of costs (such as 
transportation) compared to the BLS estimates and the costs are 
available for individual HHA providers while the BLS costs are 
aggregated for the Home Health Care Service industry.
    Similar to the current payment system, we proposed that 30-day 
periods under the PDGM would be classified as ``early'' or ``late'' 
depending on when they occur within a sequence of 30-day periods. Under 
the current HH PPS, the first two 60-day episodes of a sequence of 
adjacent 60-day episodes are considered early, while the third 60-day 
episode of that sequence and any subsequent episodes are considered 
late. Under the PDGM, we proposed that the first 30-day period would be 
classified as early and all subsequent 30-day periods in the sequence 
(second or later) would be classified as late. We proposed to adopt 
this episode timing classification for 30-day periods with the 
implementation of the PDGM. Similar to the current payment system, we 
proposed that a 30-day period could not be considered early unless 
there was a gap of more than 60 days between the end of one period and 
the start of another. The comprehensive assessment would 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.''
    Under the PDGM, we proposed that each 30-day period would 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. The 30-day period would be categorized as 
institutional if an acute or post-acute care stay occurred within the 
prior 14 days to the start of the 30-day period of care. The 30-day 
period would be categorized as community if there was no acute or post-
acute care stay in the 14 days prior to the start of the 30-day period 
of care.
    We proposed further grouping 30-day periods into one of six 
clinical groups based on the principal diagnosis. The principal 
diagnosis reported would provide information to describe the primary 
reason for which patients were receiving home health services under the 
Medicare home health benefit. The proposed six clinical groups, were as 
follows:
     Musculoskeletal Rehabilitation.
     Neuro/Stroke Rehabilitation.
     Wounds- Post-Op Wound Aftercare and Skin/Non-Surgical 
Wound Care.
     Complex Nursing Interventions.
     Behavioral Health Care.
     Medication Management, Teaching and Assessment (MMTA).
    Under the PDGM, we proposed that each 30-day period would be placed 
into one of three functional impairment levels. The level would 
indicate if, on average, given the HHA's responses on certain 
functional OASIS questions, a 30-day period was predicted to have 
higher costs or lower costs. For each of the six clinical groups, we 
proposed that total periods would be further classified into one of 
three functional impairment levels with roughly 33 percent of total 30-
day periods for all HHAs in each level. We determined how many periods 
of care would be in each functional impairment level based on the 
relative number of periods in a potential impairment level, and on the 
clustering of summed functional scores. The functional impairment level 
assignment under the PDGM is very similar to the functional level 
assignment in the current payment system.
    Finally, we proposed that 30-day periods would receive a 
comorbidity adjustment category based on the presence of secondary 
diagnoses. We proposed that, depending on a patient's secondary 
diagnoses, a 30-day period may receive ``no'' comorbidity adjustment, a 
``low'' comorbidity adjustment, or a ``high'' comorbidity adjustment. 
For low-utilization payment adjustments (LUPAs) under the PDGM, we 
proposed that the LUPA threshold would vary for a 30-day period under 
the PDGM depending on the PDGM payment group to which it was assigned. 
For each payment group, we proposed to use the 10th percentile value of 
visits to create a payment group specific LUPA threshold with a minimum 
threshold of at least 2 visits for each group.
    The proposed rule further outlined the data file construction 
process for the PDGM-related analyses, including the claims data used, 
how the data were cleaned, how OASIS data were matched to claims data, 
how measures of resource use were constructed, and the total number of 
30-day periods used for constructing the PDGM case-mix weights in the 
proposed rule (82 FR 35297 through 35298).
    The following is a summary of general comments received on the 
proposals and our responses.
    Comment: Several commenters supported various elements of PDGM. 
There was broad support for moving from the current payment system to 
one that uses a broader clinical profile of the patient. There was also 
support for the budget neutral implementation of the PDGM and the 
elimination of the service utilization domain (that is, therapy 
thresholds). Other commenters indicated they supported the PDGM, but 
stated that implementation of the PDGM should be delayed until after 
January 1, 2020 to provide assurances that there is sufficient 
information and guidance to HHAs, physicians, and Medicare 
Administrative Contractors (``MACs'') to ensure a smooth transition and 
no unintended consequences. Commenters also suggested that CMS 
implement the model incrementally or conduct a small scale 
demonstration of the model.
    Response: We thank the commenters for their support. Section 
1895(b)(2)(B) of the Act, as added by section 51001(a)(1) of the BBA of 
2018, requires the Secretary to apply a 30-day unit of service (also 
referred to as unit of payment), effective January 1, 2020. In 
addition, section 1895(b)(4)(B)(ii) of the Act, as added by section 
51001(a)(3)(B) of the BBA of 2018, requires CMS to remove therapy 
thresholds from the case-mix adjustment methodology used to adjust 
payments under the HH PPS for CY 2020 and subsequent years. The PDGM 
was developed in conjunction with a 30-day period of care and should be 
implemented simultaneously with the change in the length of the unit of

[[Page 56448]]

service. Attempting to implement the PDGM piecemeal could cause more 
burden and confusion, compared to implementing the entire model at the 
same time. With regards to conducting a demonstration, we note that a 
demonstration would likely only occur in selected areas with selected 
participants and therefore would paint a different picture of the 
effects of the model compared to what would otherwise occur on a 
national scale. Furthermore, section 1895 of the Act, as amended by the 
BBA of 2018, requires a change to the unit of payment and the 
elimination of therapy thresholds for all payments made under the HH 
PPS, rather than requiring CMS to conduct a demonstration. While we are 
finalizing our proposal to implement the PDGM beginning on January 1, 
2020, we are sensitive to the concerns expressed by commenters 
regarding provider outreach, training, billing changes and systems 
updates needed to implement the PDGM. While we work toward an 
implementation date of January 1, 2020, we look forward to a continued 
dialogue with the industry on ways to provide sufficient guidance and 
training to ensure a smooth transition to the 30-day unit of payment 
and the PDGM.
    Comment: Several commenters asked about what types of training 
material will be available regarding the PDGM. A commenter asked if and 
when the claims processing manual will be updated to reflect the PDGM. 
Additionally, a commenter asked if CMS could develop an email mailbox 
for patients to offer feedback on the PDGM.
    Response: We appreciate comments about the need for guidance and 
training prior to the implementation of the PDGM. We agree with the 
commenters that this is an area that deserves attention and we plan to 
work with HHAs and other stakeholders to ensure a smooth transition 
between the current payment model and the PDGM. We will update the 
claims processing manual and we will provide education and support more 
broadly, which may include MLN articles, program instructions, national 
provider calls, and open door forums. Once the rule is finalized, we 
will begin updating the appropriate sections of the Home Health Agency 
Billing chapter in the Medicare Claims Processing Manual. For questions 
about the Home Health Prospective Payment System (HH PPS) and the 
Medicare home health benefit, individuals can email: 
[email protected].
    Comment: Several commenters asked how CMS would monitor the PDGM. 
Specifically, commenters expressed concern that the PDGM may result in 
inappropriate practice patterns and that the PDGM might introduce 
claims processing issues that could cause delays in payment. A few 
commenters also indicated that the technical expert panel (TEP) 
convened in February, 2018 should continue to stay involved with the 
implementation and roll-out of the PDGM in order to monitor outcomes.
    Response: We will continue to monitor the payment system as we have 
done since the inception of the benefit. We will closely monitor 
patterns related to utilization, including changes in the composition 
of patients receiving the home health benefit and the types and amounts 
of services they are receiving. CMS will also carefully pay attention 
to claims processing changes needed to implement the 30-day unit of 
payment and the PDGM in order to mitigate any issues that could cause 
delays in payment. We appreciated the help of the TEP and, if needed, 
we will continue to engage the TEP or another set of key stakeholders 
as we move forward with the implementation of the PDGM for January 1, 
2020.
    Comment: Commenters stated there was limited involvement with the 
industry in the development of the PDGM. Some commenters indicated that 
CMS needs to perform studies and an evaluation of the work related to 
the PDGM and alternative payment models suggested, like the ``Risk-
Based Grouper Model''.
    Response: We thank the commenters' for their willingness to engage 
in discussion around the PDGM. Through notice and comment rulemaking 
and other processes, stakeholders always have the opportunity to reach 
out to CMS and provide suggestions for improvement in the payment 
methodology under the HH PPS. In the CY 2014 HH PPS final rule, we 
noted that we were continuing to work on improvements to our case-mix 
adjustment methodology and welcomed suggestions for improving such 
methodology as we continued in our case-mix research (78 FR 72287). The 
analyses and the ultimate development of an alternative case-mix 
adjustment methodology were shared with both internal and external 
stakeholders via technical expert panels, clinical workgroups, and 
special open door forums. We also provided high-level summaries on our 
case-mix methodology refinement work in the HH PPS proposed rules for 
CYs 2016 and 2017 (80 FR 39839, and 81 FR 76702). A detailed technical 
report was posted on the CMS website in December of 2016, additional 
technical expert panel and clinical workgroup webinars were held after 
the posting of the technical report, and a National Provider call 
occurred in January 2017 to further solicit feedback from stakeholders 
and the general public. The CY 2018 HH PPS proposed rule further 
solicited comments on a proposed alternative case-mix adjustment 
methodology--referred to as the home health groupings model, or HHGM.
    On February 1, 2018, CMS convened another TEP to gather 
perspectives and identify and prioritize recommendations from industry 
leaders, clinicians, patient representatives, and researchers with 
experience with home health care and/or experience in home health 
agency management regarding the case-mix adjustment methodology 
refinements described in the CY 2018 HH PPS proposed rule (82 FR 
35270), and alternative case-mix models submitted during 2017 as 
comments to the CY 2018 HH PPS proposed rule. During the TEP, there was 
a description and solicitation of feedback on the components of the 
proposed case-mix methodology refinement, such as resource use, 30-day 
periods, clinical groups, functional levels, comorbidity groups, and 
other variables used to group periods into respective case-mix groups. 
Also discussed were the comments received from the CY 2018 HH PPS 
proposed rule, the creation of case-mix weights, and an open discussion 
to solicit feedback and recommendations for next steps. This TEP 
satisfied the requirement set forth in section 51001(b)(1) of the BBA 
of 2018, which requires that at least one session of such a TEP be held 
between January 1, 2018 and December 31, 2018. In addition, section 
51001(b)(3) of the BBA of 2018 requires the Secretary to issue a report 
to the Committee on Ways and Means and Committee on Energy and Commerce 
of the House of Representatives and the Committee on Finance of the 
Senate on the recommendations from the TEP members, no later than April 
1, 2019. This report has already been completed and is available on the 
CMS HHA Center web page at: https://www.cms.gov/center/provider-Type/
home-Health-Agency-HHA-Center.html. CMS addressed the Risk Based 
Grouper Model in the report to the Committee on Ways and Means and 
Committee on Energy and Commerce of the House of Representatives and 
the Committee on Finance of the Senate on the recommendations from the 
TEP members. Lastly, the CY 2019 HH PPS proposed rule solicited comment 
on the proposed PDGM.
    Comment: Several commenters requested that CMS describe how the

[[Page 56449]]

proposed PDGM would impact delivery and payment innovations, such as 
Accountable Care Organizations (ACOs) and Bundled Payments for Care 
Improvement (BPCI) Models 2 and 3. Other commenters requested that CMS 
describe how the proposed PDGM fits in with the IMPACT Act-directed 
post-acute care PPS and other payment system methodology changes in 
other settings. Other commenters indicated that the PDGM would hurt 
HHVBP and the star ratings. A commenter asked if the Review Choice 
Demonstration was still needed if PDGM was implemented and indicated 
that would cause additional burden.
    Response: BPCI Models 2 and 3 ended September 30, 2018; therefore, 
BPCI Models 2 and 3 would not be affected by PDGM implementation. CMS 
will determine whether any refinements are needed to the BPCI Advanced 
Model, a new payment and service delivery model that began on October 
1, 2018, and any ACO programs and models, such as the Medicare Shared 
Savings Program and the Next Generation ACO Model as a result of PDGM 
implementation. We note that any changes determined to be necessary to 
the payment methodology used in the Medicare Shared Savings Program due 
to implementation of the PDGM would require notice and comment 
rulemaking.
    We believe that the proposed PDGM could assist with meeting the 
IMPACT Act requirement that the Secretary of Health and Human Services 
develop a technical prototype for a unified post-acute care (PAC) 
prospective payment system (PAC PPS). We believe many aspects of the 
PDGM could be used in a unified PAC PPS prototype so that payments 
under such a prototype would be based according to individual 
characteristics, as specified by the IMPACT Act. We do not believe that 
the PDGM will disrupt the HHVBP Model or the Home Health star ratings. 
The PDGM is a case-mix adjustment model intended to pay for services 
more accurately and we believe the HHVBP Model and the Home Health star 
ratings can continue unchanged when HHA periods of care are paid 
according to the case-mix adjustments of the PDGM. We do not believe 
the implementation of the PDGM will eliminate the rationale behind the 
proposed Review Choice Demonstration for Home Health Services. The PDGM 
is a case-mix adjustment model with the goal of better aligning home 
health payments with patient care needs and the cost of care, while the 
proposed Review Choice Demonstration for Home Health Services would be 
a demonstration aimed at assisting in the development of improved 
procedures to identify, investigate, and prosecute potential Medicare 
fraud occurring among HHAs providing services to Medicare 
beneficiaries.
    Comment: A commenter asked CMS to provide greater detail about the 
appeals process that will be available to help patients address any 
shortcomings in their care and/or coverage. In addition, the commenter 
stated that providers also should be able to appeal any inaccurate 
assignments to payment classifications.
    Response: The Advance Beneficiary Notice of Noncoverage (ABN) is 
issued by providers (including home health agencies and hospices), 
physicians, practitioners, and other suppliers to Original Medicare 
(fee-for-service) beneficiaries in situations where Medicare payment is 
expected to be denied for some or all services. When a home health 
patient gets an ABN, the ABN gives clear directions for getting an 
official decision from Medicare about payment for home health services 
and supplies and for filing an appeal. An HHA must also furnish a 
``Home Health Change of Care Notice'' (HHCCN) to beneficiaries when the 
beneficiary's home health plan of care is changing because the Agency 
reduces or stops providing home health services or supplies for 
business-related reasons or because the beneficiary's physician changed 
orders for such services or supplies. An HHA must also furnish a 
``Notice of Medicare Non-Coverage'' (NOMNC) at least 2 days before all 
covered services end. When home health services are ending, 
beneficiaries may have the right to an expedited appeal if they believe 
the services are ending too soon. During an expedited appeal, a 
Beneficiary and Family Centered Care Quality Improvement Organization 
(BFCC-QIO) will examine the case and decide whether home health 
services need to continue. If the beneficiary is dissatisfied with the 
determination by the QIO, in accordance with Sec.  405.1204, the 
beneficiary has the right to an expedited reconsideration by a 
Qualified Independent Contractor (QIC). If the beneficiary is 
dissatisfied with the determination by the QIC, the beneficiary then 
has the right to request an Administrative Law Judge hearing or review 
of a dismissal, Medicare Appeals Council review, and judicial review by 
a federal district court, so long as jurisdictional requirements are 
met (as outlined by 42 CFR part 405, subpart I).
    With regards to inaccurate assignments to payment classifications 
under the PDGM, corrections to payment classifications on claims will 
not require appealing the initial determination. Because the assignment 
of the payment classification will be performed by the claims system 
based on data reported by the HHA on the claim or the corresponding 
patient assessment, the provider could correct this information to 
change the assignment. The HHA could submit a correction OASIS 
assessment and subsequently adjust their claim after the corrected 
assessment is accepted, or simply correct the payment-related items on 
the claim (occurrence code, diagnosis code, etc.) and submit the 
adjusted claim.
    Comment: Another commenter asked CMS to review the current therapy 
assessment burden for providers and the time points in which those 
assessments need to be completed given that the PDGM does not use a 
service utilization domain.
    Response: Prior to January 1, 2015, therapy reassessments were 
required to be performed on or ``close to'' the 13th and 19th therapy 
visits and at least once every 30 days (75 FR 70372). As a reminder, in 
the CY 2015 HH PPS final rule, CMS eliminated the requirement for 
reassessments to be performed on or ``close to'' the 13th and 19th 
visits. Instead, the current regulations at Sec.  409.44(c)(2)(B) 
require a qualified therapist (instead of an assistant) to provide the 
needed therapy service and functionally reassess the patient at least 
every 30 days. Where more than one discipline of therapy is being 
provided, a qualified therapist from each of the disciplines must 
provide the needed therapy service and functionally reassess the 
patient.
    Comment: A commenter indicated that under the PDGM those HHAs with 
lower margins will be paid less and those HHAs with higher margins will 
be paid more. Another commenter indicated that there should be a site 
of service adjustment for patients in assisted living as their needs 
are greater.
    Response: The goal of the PDGM is to more closely align payments 
with costs based on patient characteristics. The PDGM was not designed 
to help agencies achieve any particular margin. While a commenter noted 
that patients in assisted living facilities may have greater needs, we 
also note that an HHA may have lower costs when treating multiple 
patients within the same assisted living facility due to economies of 
scale (lower per visit costs due to transportation and other overhead 
costs spread over more visits). We will analyze data after 
implementation of the PDGM to determine whether a site of

[[Page 56450]]

service adjustment may be warranted in the future.
    Comment: Another commenter asked if CMS would reimburse 30-day 
periods without a skilled visit when a skilled visit exists for the 60-
day episode and certification period.
    Response: Current regulation at Sec.  409.45(a) does not permit 
coverage of dependent services (home health aide services, medical 
social services, occupational therapy, durable medical equipment, 
medical supplies, or intern and resident services) furnished after the 
final qualifying skilled service (skilled nursing; physical therapy; 
speech-language pathology; or a continuing occupational therapy after 
the need for skilled nursing, physical therapy and/or speech-language 
pathology services have ceased), except when the dependent service was 
not followed by a qualifying skilled service as a result of the 
unexpected inpatient admission or death of the beneficiary, or due to 
some other unanticipated event. We did not propose to change the 
regulation regarding coverage of dependent services after qualifying 
skilled services have ceased in this rule. Therefore, we would not pay 
30-day periods without a qualifying skilled service. Furthermore, HHAs 
should not be billing for dependent services that occur after the last 
qualifying skilled service, unless such services occurred due to an 
unexpected inpatient admission or death of the beneficiary, or due to 
some other unanticipated event.
    Comment: A commenter asked whether CMS would give guidance to MA 
plans to implement the PDGM. Another commenter asked how Medicare as a 
secondary payer would be impacted by the PDGM.
    Response: We acknowledge that some Medicare Advantage plans could 
change their payment models to mirror PDGM, while others may not change 
their payment models in relation to the changes finalized in this rule. 
It should be noted that, as private plans, Medicare Advantage plans do 
not have to use the FFS payment methodology. Medicare Advantage payment 
models for home health currently take a wide variety of forms and some 
may already be approximating the structure of PDGM, using patient 
characteristics rather than service utilization as the basis for 
payment. We will work generally with stakeholders, including these 
private plans, to help ensure that adequate education and resources are 
available for all parties. The implementation of the PDGM will have no 
impact on the Medicare as a secondary payer process.
    Final Decision: We are finalizing the change in the unit of payment 
from 60 days to 30 days, effective for 30-day periods of care that 
start on or after January 1, 2020, as proposed and in accordance with 
the provisions in the BBA of 2018. In addition, we are finalizing the 
PDGM, with modification, also effective for 30-day periods of care that 
start on or after January 1, 2020. We are also finalizing the 
corresponding regulations text changes as described in section III.F.13 
of this final rule with comment period. We will provide responses to 
more detailed comments regarding the PDGM and the calculation of the 
30-day budget neutral payment amount for CY 2020 further in this final 
rule with comment period.
2. Methodology Used To Calculate the Cost of Care
    To construct the case-mix weights for the PDGM proposal, the costs 
of providing care needed to be determined. A Wage-Weighted Minutes of 
Care (WWMC) approach is used in the current payment system based on 
data from the BLS. However, we proposed to adopt a Cost-per-Minute plus 
Non-Routine Supplies (CPM+NRS) approach, which uses information from 
HHA Medicare cost reports and home health claims. Under the proposed 
PDGM, we group periods of care into their case-mix groups taking into 
account admission source, timing, clinical group, functional level, and 
comorbidity adjustment. From there, the average resource use for each 
case-mix group dictates the group's case-mix weight. We proposed that 
resource use is the estimated cost of visits recorded on the home 
health claim plus the cost of NRS recorded on the claims. The cost of 
NRS is generated by taking NRS charges on claims and converting them to 
costs using a NRS cost to charge ratio that is specific to each HHA. 
When NRS is factored into the average resource use, NRS costs are 
reflected in the average resource use that establishes the case-mix 
weights. Similar to the current system, NRS would still be paid 
prospectively under the PDGM, but the PDGM eliminates the separate 
case-mix adjustment model for NRS. See the proposed rule for more 
detail on the steps used to generate the measure of resource use under 
the proposed CPM+NRS approach (83 FR 32385 through 32388).
    The following is a summary of the public comments received on the 
``Methodology Used to Calculate the Cost of Care'' proposal and our 
responses.
    Comment: Several commenters objected to the use of Medicare cost 
report data rather than Wage-Weighted Minutes of Care (WWMC) in the 
methodology used to calculate the cost of care. Commenters indicated 
that HHAs' inputs, as demonstrated through cost reports, are not 
accurately reflecting the effects of changes in utilization, provider 
payments, and provider supply that have occurred over the past decade. 
They argue that the strength and utility of episode-specific cost 
depends on the accuracy and consistency of agencies' reported charges, 
cost-to-charge ratios, and episode minutes and that there are no 
incentives for ensuring the accuracy of their cost reports; and 
therefore the data are presumptively inaccurate. Several commenters 
also indicated that the use of cost report data in lieu of WWMC favors 
facility-based agencies because they have the ability to allocate 
indirect overhead costs from their parent facilities to their service 
cost and argue that the PDGM will reward inefficient HHAs with 
historically high costs. Finally, a few commenters indicated that they 
would support the CPM+NRS approach only if HHA cost reports were 
audited.
    Response: We believe that the use of HHA Medicare cost reports 
better reflects changes in utilization, provider payments, and supply 
amongst Medicare-certified HHAs that occur over time. Under the WWMC 
approach, using the BLS average hourly wage rates for the entire home 
health care service industry does not reflect changes in Medicare home 
health utilization that impact costs, such as the allocation of 
overhead costs when Medicare home health visit patterns change. Using 
data from HHA Medicare cost reports better represents the total costs 
incurred during a 30-day period (including, but not limited to, direct 
patient care contract labor, overhead, and transportation costs), while 
the WWMC method provides an estimate of only the labor costs (wage and 
fringe benefit costs) related to direct patient care from patient 
visits that are incurred during a 30-day period. We note the 
correlation coefficient between the two approaches to calculating 
resource use is equal to 0.8537 (n=8,521,924). Correlation coefficients 
are used in statistics to measure how strong the relationship is 
between two variables. The closer to 1 the stronger the relationship 
(zero means no relationship). Therefore, the relationship between using 
the CPM+NRS approach compared to the WWMC approach is very similar. In 
conjunction with this final rule with comment period, we posted an 
excel file on the HHA Center page that includes the case-mix weights 
produced using the proposed CPM+NRS approach and those produced using 
the current

[[Page 56451]]

WWMC approach in calculating resource use.\10\ The correlation 
coefficient between the two sets of weights (CPM+NRS versus WWMC using 
BLS data) is 0.9806, meaning the two methods produce very similar case-
mix weights.
---------------------------------------------------------------------------

    \10\ https://www.cms.gov/center/provider-Type/home-Health-
Agency-HHA-Center.html.
---------------------------------------------------------------------------

    In response to comments regarding the accuracy of HHA Medicare cost 
report data, as we indicated in the proposed rule, we applied the 
trimming methodology described in detail in the ``Analyses in Support 
of Rebasing & Updating Medicare Home Health Payment Rates'' Report 
available at: https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf. This is also the trimming 
methodology outlined in the CY 2014 HH PPS proposed rule (78 FR 40284) 
in determining the rebased national, standardized 60-day episode 
payment amount. For each discipline and for NRS, we also followed the 
methodology laid out in the ``Rebasing Report'' by trimming out values 
that fall in the top or bottom 1 percent of the distribution across all 
HHAs. This included the cost per visit values for each discipline and 
NRS cost-to-charge ratios that fall in the top or bottom 1 percent of 
the distribution across all HHAs. Normalizing data by trimming out 
missing or extreme values is a widely accepted methodology both within 
CMS and amongst the health research community. In eliminating missing 
or questionable data with extreme values from the data we obtain a more 
robust measure of average costs per visit that is reliable for the 
purposes of establishing base payment amounts and case-mix weights 
under the HH PPS. Using HHA Medicare cost report data to establish the 
case-mix relative weight aligns with the use of this data in 
determining the base payment amount under the HH PPS. Furthermore, we 
would note that each HHA Medicare cost report is required to be 
certified by the Officer or Director of the home health agency as being 
true, correct, and complete, with potential penalties should any 
information in the cost report be a misrepresentation or falsification 
of information. The HHA Medicare Cost Report (MCR) Form (CMS-1728-94) 
with this certification statement is available at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1728-94.html.
    As always, we encourage providers to fill out the Medicare cost 
reports as accurately as possible. We remind the industry again that 
each home health cost report is required to be certified by the Officer 
or Director the home health agency. We also welcome suggestions for 
improving compliance and accuracy on cost reports within the current 
cost reporting forms. We will explore whether it is feasible to provide 
some sort of national, mandatory training on completing the Medicare 
HHA cost report form and whether and to what extent CMS can conduct 
more desk reviews and audits of Medicare HHA cost reports in the 
future.
    With regards to the case-mix weights rewarding inefficient 
providers with high costs or facility-based HHAs, each HHA's costs 
impact only a portion of the calculation of the weights and costs are 
blended together across all HHAs. To put it simply, the payment 
regression was estimated using 8,521,924 30-day periods from 10,522 
providers. On average, each provider contributed 841 30-day periods to 
the payment regression, which is only 0.010 percent of all 30-day 
periods. Therefore, including or excluding any single HHA on average 
would not dramatically impact the results of the payment regression. 
Additionally, in the PDGM, we estimate the payment regression using 
provider-level fixed effects; therefore we are looking at the within 
provider variation in resource use. That is, we may find there are two 
HHAs with different cost structures (for example, HHA ``A'') has costs 
that are on average 1.5 times as high as HHA ``B'') but both HHAs can 
still have similar patterns in resource use across their 30-day 
periods. Since the PDGM is controlling for the variation in the general 
costs for HHAs with high and lower costs, including those that have 
variation in costs due to being facility-based versus freestanding, we 
do not agree that using the CPM+NRS approach in estimating resource use 
introduces a bias that favors inefficient or facility-based HHAs.
    Comment: Several commenters stated that Non-Routine Supplies (NRS) 
should not be incorporated into the base rate and then wage-index 
adjusted. The industry stated that HHAs' supply costs are approximately 
the same nationally, regardless of rural or urban locations and 
regardless of the wage-index. Commenters stated that including NRS in 
the base rate will penalize rural providers and unnecessarily overpay 
for NRS in high wage-index areas. Another commenter indicated that CMS 
should lower the labor-related share to account for NRS in the base 
payment rate.
    Response: As we noted in the CY 2008 HH PPS final rule with 
comment, use of NRS is unevenly distributed across episodes of care in 
home health. In addition, the majority of episodes do not incur any NRS 
costs and, at that time, the current payment system overcompensated for 
episodes with no NRS costs. We found that patients with certain 
conditions, many of them related to skin conditions, were more likely 
to require high non-routine medical supply utilization (72 FR 49850). 
We noted in the CY 2008 HH PPS proposed rule that, in particular, 
commenters were concerned about the adequacy of payment for some 
patients with pressure ulcers, stasis ulcers, other ulcers, wounds, 
burns or trauma, cellulitis, and skin cancers (72 FR 25427). At that 
time (and currently), the clinical levels for the HH PPS did not group 
patients with similar supply needs together; therefore, for CY 2008 we 
created a separate case-mix adjustment process for NRS based on a NRS 
conversion factor and six severity levels. We noted that the NRS case-
mix adjustment process did not have a high degree of predictive 
accuracy, possibly due to the limited data available to model NRS costs 
and the likelihood that OASIS does not have any measures available for 
some kinds of NRS. We stated in the CY 2008 HH PPS final rule that we 
would continue to look for ways to improve our approach to account for 
NRS by exploring alternative methods for accounting for NRS costs and 
payments in the future (72 FR 25428). We believe that the PDGM offers 
an alternative method for accounting for NRS costs and payments by 
grouping patients more likely to require high NRS utilization into two 
groups--the Wound group and the Complex Nursing Interventions group. 
For example, while the Wound group and Complex Nursing Interventions 
groups comprise about 10 percent and 4 percent of all 30-day periods of 
care, respectively; roughly 30 percent of episodes where NRS was 
supplied was for Wound and Complex Nursing Interventions groups and 47 
percent of NRS charges fall into the Wound and Complex Nursing 
Interventions groups. We note that CY 2017 claims data indicates that 
about 71 percent of 60-day episodes did not provide any NRS.
    As noted by the commenters, in the CY 2008 HH PPS proposed rule we 
stated that because the market for most NRS is national, we proposed 
not to have a geographic adjustment to the conversion factor (72 FR 
25430). More accurately, because the NRS conversion factor reflected 
supplies and not wage and wage-related costs, we did not subject NRS 
payments to the geographic wage adjustment process. However, we

[[Page 56452]]

note that we did not revise the labor-related share to reflect the 
exclusion of NRS payments from the national, standardized 60-day 
episode payment amount. The labor-related share (LRS), effective for CY 
2013 to CY 2018 home health payments of 78.535 percent is based on the 
2010-based HHA market basket where the LRS is equal to the compensation 
cost weight, including salaries, benefits, and direct patient care 
contract labor. The non-labor-related share of 21.465 includes the 
relative costs for the NRS supplies. For comparison purposes, if we had 
removed NRS supplies from the calculations in the 2010-based Home 
Health market basket, the LRS would have been 79.7 percent and the non-
labor-related share would have been 20.4 percent. Again, the LRS of 
78.535 percent did not include NRS costs and therefore, NRS was not 
subjected to the geographic adjustment as it does not reflect wage and 
wage related costs. Similarly, the CY 2019 LRS of 76.1 percent, based 
on the 2016-based HHA market basket, also does not include NRS.
    Comment: A few commenters stated that based on their operational 
experiences with clinical staffing labor costs, HHA cost report data 
suggests more parity exists between skilled nursing (``SN'') versus 
physical therapist (``PT'') costs than in fact exists. Commenters 
stated that BLS data showing a 40 percent difference between SN and PT 
costs are more reflective of the commenters' human resources/staffing 
experiences in the markets where they operate. As such, commenters 
believe the use of cost report data would cause the PDGM model to 
overpay for nursing services and underpay for therapy services. A 
commenter indicated that contract staff are more expensive than staff 
that are hired and indicated this will widen the gap between nursing 
and therapy costs.
    Response: The HHA Medicare cost report data reflects all costs and, 
most importantly, it reflects all labor costs, including contract labor 
costs. The BLS data only reflects employed staff. This may at least 
partially explain why a 40 percent variation between SN and PT costs is 
not evident in the cost report data. The HHA Medicare cost report data 
shows about a 20 percent difference between PT and SN compensation 
costs (wages and salaries, employee benefits and contract labor) per 
visit, which is consistent with the difference between PT and SN total 
costs per visit. Moreover, in aggregate, about 15 percent of 
compensation costs are contract labor costs and this varies among type 
of visit with contract labor costs accounting for a much higher 
proportion of therapy visit compensation costs compared to skilled 
nursing visit compensation cost. Utilization also varies among 
freestanding providers with smaller providers having a higher 
proportion of contract labor costs, particularly for therapy services 
compared to larger providers. It also seems to vary by region. The 
decision of whether to/or what proportion of contract labor to use is 
at the provider's discretion. In regards to the comment on expense of 
contracted services, we note that using cost report data allows those 
types of relationships to be fully measured. Finally, we note that in 
order to be eligible for Medicare HH PPS payments, providers must 
complete the HHA Medicare cost report; therefore, if providers are 
required to complete the cost report, then we believe such data are 
appropriate to use for payment purposes.
    Comment: Several commenters indicated that WWMC and CPM+NRS results 
should be blended together to minimize disruptions.
    Response: CMS appreciates this suggestion. However, there are 
difficulties in blending due to the WWMC and CPM+NRS approaches 
measuring different outcomes. WWMC is focused on cost of labor while 
CPM+NRS takes a more diverse approach and accounts for labor, overhead, 
and NRS. As discussed previously, there is very high correlation 
between the two approaches, meaning they produce very similar weights.
    Comment: Another commenter indicated costs related to enrollment 
should be included in the calculation of resource use.
    Response: These costs may be included in staffing and overhead 
costs and, if so, would be captured by the CPM+NRS approach.
    Comment: A commenter cited a report that indicated for ``on-the-job 
activities undertaken by employees, HHS Guidelines recommend using 
estimates of pre-tax wages for the particular industry and affected 
occupation, to the extent possible, and adding estimate of benefits and 
indirect costs.''
    Response: The goal of the CPM+NRS methodology is to not simply 
measure costs related to on-the-job activities. In order to account for 
a broader array of costs, which is necessary to assign accurate payment 
rates, we instead used information from cost reports which is more 
detailed than information on wages, benefits, and indirect cost.
    Final Decision: We are finalizing our proposal to adopt a Cost-per-
Minute plus Non-Routine Supplies (CPM+NRS) approach in estimating 
resource use, which uses information from HHA Medicare cost reports. 
The following steps would be used to generate the measure of resource 
use under the CPM+NRS approach:
    (1) From the cost reports, obtain total costs for each of the six 
home health disciplines for each HHA.
    (2) From the cost reports, obtain the number of visits by each of 
the six home health disciplines for each HHA.
    (3) Calculate discipline-specific cost per visit values by dividing 
total costs [1] by number of visits [2] for each discipline for each 
HHA. For HHAs that do not have a cost report available (or a cost 
report that was trimmed from the sample), imputed values are used as 
follows:
     A state-level mean is used if the HHA was not hospital-
based. The state-level mean is computed using all non-hospital based 
HHAs in each state.
     An urban nationwide mean is used for all hospital-based 
HHAs located in a Core-based Statistical Area (CBSA). The urban nation-
wide mean is computed using all hospital-based HHAs located in any 
CBSA.
     A rural nationwide mean is used for all hospital-based 
HHAs not in a CBSA. The rural nation-wide mean is computed using all 
hospital-based HHAs not in a CBSA.
    (4) From the home health claims data, obtain the average number of 
minutes of care provided by each discipline across all episodes for a 
HHA.
    (5) From the home health claims data, obtain the average number of 
visits provided by each discipline across all episodes for each HHA.
    (6) Calculate a ratio of average visits to average minutes by 
discipline by dividing average visits provided [5] by average minutes 
of care [4] by discipline for each HHA.
    (7) Calculate costs per minute by multiplying the HHA's cost per 
visit [3] by the ratio of average visits to average minutes [6] by 
discipline for each HHA.
    (8) Obtain 30-day period costs by multiplying costs per minute [7] 
by the total number of minutes of care provided during a 30-day period 
by discipline. Then, sum these costs across the disciplines for each 
period.
    NRS costs are added to the resource use calculated in [8] in the 
following way:
    (9) From the cost reports, determine the NRS cost-to-charge ratio 
for each HHA. Imputation for missing or trimmed values is done in the 
same manner as it was done for cost per visit (see [3] as previously 
indicated).

[[Page 56453]]

    (10) From the home health claims data, obtain NRS charges for each 
period.
    (11) Obtain NRS costs for each period by multiplying charges from 
the home health claims data [10] by the cost-to-charge ratio from the 
cost reports [9] for each HHA.
    Resource use is then obtained by:
    (12) Summing costs from [8] with NRS costs from [11] for each 30-
day period.
3. Change From a 60-Day to a 30-Day Unit of Payment
a. Background
    Currently, HHAs are paid for each 60-day episode of home health 
care provided. By examining the resources used within a 60-day episode 
of care, we identified differences in resources used between the first 
30-day period within a 60-day episode and the second 30-day period 
within a 60-day episode. Episodes have more visits, on average, during 
the first 30 days compared to the last 30 days. Costs are much higher 
earlier in the episode and lesser later on, therefore, dividing a 
single 60-day episode into two 30-day periods more accurately 
apportions payments. In addition, with the removal of therapy 
thresholds from the case-mix adjustment methodology under the HH PPS, a 
shorter period of care reduces the variation and improves the accuracy 
of the case-mix weights generated under the PDGM.
    Section 1895(b)(2)(B) of the Act, as added by section 51001(a)(1) 
of the BBA of 2018, requires the Secretary to apply a 30-day unit of 
service for purposes of implementing the HH PPS, effective January 1, 
2020. We note that we interpret the term ``unit of service'' to be 
synonymous with ``unit of payment'' and will henceforth refer to ``unit 
of payment'' in this final rule with comment period with regards to 
payment under the HH PPS. Therefore, in accordance with section 
1895(b)(2)(B) of the Act, we proposed changing the unit of payment from 
a 60-day episode of care to 30-day unit of payment, effective January 
1, 2020.
    Comment: Many commenters understood the requirement for CMS to 
change from a 60-day episode to a 30-day unit of payment. Several 
commenters appreciated that CMS was maintaining the existing 60-day 
timing for comprehensive assessments, certifications and 
recertifications, and plans of care. Some commenters expressed concern 
that the 30-day payment period was more confusing because it is on a 
different a timeline than for other home health requirements such as 
the certification/recertification, OASIS assessments and updates to the 
plan of care.
    Response: CMS thanks commenters for recognizing that the change 
from a 60-day unit of payment to a 30-day unit of payment is required 
by law and we do not have the discretion to implement a different 
policy. We believe that changing to a 30-day unit of payment will more 
accurately pay for services in accordance with patient characteristics 
and is a better approach to focus on patient care needs. We believe 
maintaining the existing timeframes for updates to the comprehensive 
assessment, updates to the plan of care, and recertifications will help 
make the transition to a new case-mix adjustment methodology more 
seamless for HHAs. Under the PDGM, the initial certification of patient 
eligibility, plan of care, and comprehensive assessment are valid for 
two 30-day periods of care (that is, for 60 days of home health care) 
in accordance with the home health regulations at 42 CFR 409.43 and 
424.22, and the home health CoPs at 42 CFR 484.55. Each 
recertification, care plan update, and comprehensive assessment update 
will also be valid for two 30-day periods of care, also in accordance 
with the home health regulations at 42 CFR 409.43(e) and 424.22(b), and 
the home health CoPs at 484.60(c).
    We also note that not all home health requirements have a 60-day 
timeframe. For example, OASIS reporting regulations require the OASIS 
to be completed within 5 days and transmitted within 30 days of 
completing the assessment of the beneficiary. In addition, physical, 
occupational, and speech therapists must provide the needed therapy 
service and functionally reassess the patient at least every 30 
calendar days. Home health is not the only care setting where billing 
and certifications are not done in the same timeframe. For example, 
hospices must certify and recertify patients every 60-90 days and they 
bill on a monthly basis. Previous to the inception of the HH PPS, HHAs 
also billed on a monthly basis even though the plan of care and 
certifications were completed every 60 days.
    Comment: Many commenters described the burden that would exist in 
switching to a 30-day period. Some commenters indicated their overhead 
costs would increase because they would have to double their billing 
and CMS should account for those costs. Some commenters believe that 
switching to 30-days would result in documentation errors and increased 
administrative burdens to both providers and to CMS due to an increase 
in claim submissions, resubmissions, and appeals. Some commenters 
indicated that switching to a 30-day billing cycle would result in a 
need to change current software and would require additional training 
for the providers. Commenters remarked they did not have the manpower 
to implement this change and that it goes against the Secretary's goal 
of reducing burden. Many commenters expressed concern that switching to 
a 30-day period would cause undue burden because of the current 
difficulty in getting physicians to sign the plan of care in a timely 
manner.
    Response: Under section 1895(b)(2)(B) of the Act, we are required 
to apply a 30-day unit of service for purposes of implementing the HH 
PPS, effective January 1, 2020. We appreciate the commenters' concern 
regarding burden surrounding the change in the unit of payment from a 
60-day episode to a 30-day period. While the change from a 60-day 
episode to a 30-day period may increase the billing frequency for final 
claims, we note that this change should not result in a measurable 
increase in burden, as many of the data elements that are used to 
populate an electronic claims submission will remain the same from one 
30-day period to the next. HHAs are required to line-item bill each 
visit performed and whether each visit is recorded on a single 60-day 
claim or the visits are recorded on two different 30-day claims should 
not result in a measureable burden increase. Also, current data for CY 
2017 suggests that nearly \1/3\ of all 60-day periods would not produce 
a second 30-day period and would not require a second bill to be 
submitted. The proposed elimination of unnecessary items from the 
OASIS, especially those items no longer needed on follow-up assessments 
under the PDGM, would result in a decrease in regulatory burden, as 
discussed in section V. of this final rule with comment period. We 
remind commenters that prior to the inception of the HH PPS, HHAs also 
billed on a monthly basis even though the plan of care and 
certifications were completed every 60 days. We believe that the 30-day 
period is appropriate even if some requirements in home health have 60-
day timeframes as a 30-day period of care under the PDGM better aligns 
home health payments with the costs of providing care. While we do not 
anticipate any increases in the numbers of appeals because of the 
implementation of the PDGM, we plan to conduct training and education 
for both HHAs and the MACs on the

[[Page 56454]]

operational aspects of the PDGM to mitigate any issues with claims 
submissions, resubmissions, and appeals.
    Just like in the current system, under the PDGM, before a provider 
submits a final claim, the HHA will need to have a completed OASIS 
assessment, signed certification, orders, and plan of care. Our 
expectation is that the HHA will obtain the signed physician 
certification and plan of care timely. As we have reiterated in 
previous rulemaking and in sub-regulatory guidance, the certification 
must be complete prior to when an HHA bills Medicare for payment; 
however, physicians should complete the certification when the plan of 
care is established, or as soon as possible thereafter. This is 
longstanding CMS policy as referenced in Pub 100-01, Medicare General 
Information, Eligibility, and Entitlement Manual, chapter 4, section 
30.1.\11\ As stated in sub-regulatory guidance in the Pub. 100-02, 
Medicare Benefit Policy Manual, chapter 7, section, section 30.5.1, 
``it is not acceptable for HHAs to wait until the end of a 60-day 
episode of care to obtain a completed certification/recertification.'' 
Per the regulations at Sec.  409.43(c), if the HHA does not have 
detailed orders for the services to be rendered, the plan of care must 
either be signed or immediately sent to the physician for signature at 
the time that the agency submits its request for anticipated payment 
(submitted at the start of care after the first visit is performed). 
The Conditions of Participation (CoPs) require the Outcome and 
Assessment Information Set (OASIS) to be completed within 5 days and 
submitted within 30 days of completion. Under the PDGM, the initial 
certification of patient eligibility, plan of care, and comprehensive 
assessment are valid for two 30-day periods of care. Each 
recertification, care plan update, and comprehensive assessment update 
will also be valid for two 30-day periods of care.
---------------------------------------------------------------------------

    \11\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ge101c04.pdf.
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    Comment: Another commenter indicated that if there was a 30-day 
period then the face-to-face encounter requirement provision could be 
eliminated. Another commenter asked if all physicians' orders must be 
signed and returned before the HHA can bill the first 30-day period. A 
commenter questioned what would occur with episodes where a portion of 
the payment started prior to the implementation date of January 1, 
2020. Another commenter questioned what would happen if a patient's 
diagnosis changes for the second 30-day period, as no additional 
comprehensive assessment is required before the second payment period.
    Response: The face-to-face requirement is statutorily required 
under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act as part of 
the certification for home health services. As a condition of payment 
for Medicare home health benefits, a face-to-face encounter must meet 
the requirements as set forth at Sec.  424.22(a)(1)(v). The intent of 
the face-to-face encounter requirement is to achieve greater physician 
accountability in certifying a patient's home health eligibility and in 
establishing a patient's plan of care. As such, this requirement is 
unrelated to the switch from a 60-day episode to a 30-day period. 
Likewise, the requirements for submission of home health claims have 
not changed. The regulations at Sec.  409.43 state that in order to 
submit a final claim for payment, the plan of care and any physician's 
orders must be signed and dated by the physician before the HHA bills 
for the care.
    For implementation purposes, the 30-day payment amount would be 
paid for home health services that start on or after January 1, 2020. 
More specifically, for 60-day 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 would be the CY 2020 national, standardized 60-day 
episode payment amount. For home health periods of care that begin on 
or after January 1, 2020, the unit of payment would now be a 30-day 
period and payment made under the Medicare HH PPS would be the CY 2020 
national, standardized prospective 30-day payment amount. For home 
health periods of care that begin on or after December 2, 2020 through 
December 31, 2020 and end on or after January 1, 2021, the HHA would be 
paid the CY 2021 national, standardized prospective 30-day payment 
amount.
    As we have stated, the requirements for when to update the 
comprehensive assessment remain unchanged. For example, if the HHA does 
not need to update the comprehensive assessment prior to recertifying 
the patient (for which the comprehensive assessment would be completed 
within the last 5 days of every 60 days beginning with the start of 
care date), then responses from the start of care OASIS would be used 
for determining the functional impairment level for both the first and 
second 30-day periods. The follow-up OASIS completed near the time of 
recertification would be used for the third and fourth 30-day periods 
of care. If, for example, the HHA needs to complete a resumption of 
care OASIS within 48 hours of the patient returning to home health 
after being transferred and admitted to the hospital for 24 hours or 
more and this occurs during the first 30-day period of care, then the 
responses for functional items from the resumption of care assessment 
would be used to determine the functional impairment level for the 
second 30-day period of care.
    With regards to diagnosis codes, the PDGM uses the diagnoses from 
the home health claim to group a 30-day home health period of care into 
a clinical group and to determine if there is a comorbidity adjustment. 
If a home health patient has any changes in diagnoses (either the 
principal or secondary), this would be reflected on the home health 
claim and the case-mix weight could change accordingly. However, we 
would expect that the HHA clinical documentation would also reflect 
these changes and any communication/coordination with the certifying 
physician would also be documented. The home health CoPs at Sec.  
484.60(c) require that the HHA must promptly alert the relevant 
physician(s) to any changes in the patient's condition or needs that 
suggest that outcomes are not being achieved and/or that the plan of 
care should be altered.
b. 30-Day Unit of Payment
    Section 1895(b)(3)(A)(iv) of the Act, requires CMS 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. As also required by 1895(b)(3)(A)(iv) of 
the Act, to calculate a 30-day payment amount in a budget- neutral 
manner, we are required to make assumptions about, and take into 
account behavior changes that could occur as a result of the 
implementation of the 30-day unit of payment and case-mix adjustment 
factors 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 application of the home health 
applicable percentage increase, the adjustment for case-mix changes, 
the adjustment if quality data is not reported, and the productivity 
adjustment.

[[Page 56455]]

    To calculate the 30-day budget-neutral payment amount, 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: This is based on the principal 
diagnosis code for the patient as reported by the HHA on the home 
health claim. Our proposed assumption was that HHAs will change their 
documentation and coding practices and put the highest paying diagnosis 
code as the principal diagnosis code in order to have a 30-day period 
be placed into a higher-paying clinical group.
     Comorbidity Coding: The PDGM further adjusts payments 
based on patients' secondary diagnoses as reported by the HHA on the 
home health claim. OASIS only allows HHAs to designate 1 principal 
diagnosis and 5 secondary diagnoses while the home health claim allows 
HHAs to designate 1 principal diagnosis and 24 secondary diagnoses. Our 
proposed assumption was that by taking into account additional ICD-10-
CM diagnosis codes listed on the home health claim (beyond the 6 
allowed on the OASIS), more 30-day periods of care will receive a 
comorbidity adjustment
     LUPA Threshold: Under the proposed PDGM, our proposed 
assumption was 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.
    If no behavioral assumptions were made, we estimated that the 30-
day payment amount needed to achieve budget neutrality would be 
$1,873.91. The clinical group and comorbidity coding assumptions would 
result in the need to decrease the budget-neutral 30-day payment amount 
to $1,786.54 (a 4.66 percent decrease from $1,873.91). Adding the LUPA 
assumption would require us to further decrease that amount to 
$1,753.68 (a 6.42 percent decrease from $1,873.91). Because we proposed 
to implement the 30-day unit of payment and the PDGM for CY 2020, we 
would propose the actual 30-day payment amount in the CY 2020 HH PPS 
proposed rule calculated using CY 2018 home health utilization data and 
we would calculate this amount before application of the proposed home 
health update percentage required for CY 2020 (as required by section 
1895(b)(3)(B)(i) of the Act). In the proposed rule, we noted that we 
are also required under section 1895(b)(3)(D)(i) of the Act, as added 
by section 51001(a)(2)(B) of the BBA of 2018, to analyze data for CYs 
2020 through 2026, after implementation of the 30-day unit of payment 
and new case-mix adjustment methodology, to annually determine the 
impact of differences between assumed behavior changes and actual 
behavior changes on estimated aggregate expenditures. We interpret 
actual behavior change to encompass both behavior changes that were 
previously outlined, as assumed by CMS when determining the budget-
neutral 30-day payment amount for CY 2020, and other behavior changes 
not identified at the time the 30-day payment amount for CY 2020 is 
determined.
    We solicited comments on the proposed behavior change assumptions 
previously outlined to be used in determining the 30-day payment amount 
for CY 2020.
    The following is a summary of the public comments received on the 
``30-day Unit of Payment'' proposals and our responses.
    Comment: Some commenters expressed support for the inclusion of 
behavioral assumptions in calculating the budget-neutral 30-day payment 
amount. Some commenters stated that using these behavioral assumptions 
may help mitigate potential program integrity issues which could cause 
disruptions in patient care.
    Response: We thank commenters for their remarks supporting the 
behavioral assumptions. The purpose of these behavioral assumptions is 
not to incorporate a built-in program integrity measure, but rather CMS 
is required by law to make behavioral assumptions when calculating a 
30-day budget-neutral payment amount for CY 2020. Also as required by 
section 1895(b)(3)(D)(i) of the Act, as added by section 51001 of the 
BBA of 2018, we will analyze the impact of the assumed versus the 
actual behavior change after the implementation of the PDGM and the 30-
day unit of payment to determine if any payment adjustment, either 
upward or downward, is warranted. We will monitor utilization trends 
after implementation of the PDGM in CY 2020 to identify any aberrant 
behavior or significant changes in practice patterns that may signal 
potential program integrity concerns and investigate such occurrences 
accordingly.
    Comment: The majority of commenters stated that CMS should not 
apply behavioral assumptions industry-wide as it punishes all HHAs for 
the performance of small set of agencies and these commenters expressed 
concern over what they describe as an adversarial approach to assumed 
behavior changes. Many of the commenters were concerned with the broad 
assumption by CMS that HHAs would indulge in ``gaming'' and unethical 
behavior to compensate for the changes within the PDGM model. It was 
stated that CMS should instead do more targeted program integrity 
efforts, such as creating a system of audits and significant monetary 
or other punishments, or adjust payments only for HHAs whose 
reimbursement falls outside normal variations. It was also suggested 
that HHAs that do not actually change their behavior in response to the 
PDGM should have a different payment rate structure compared to HHAs 
that do change their behavior.
    Response: By including behavior change assumptions in the proposed 
calculation of the 30-day payment amount, as required by statute, we 
did not intend to imply that HHAs would engage in unethical behavior; 
therefore, these assumptions are not meant to be punitive. We 
acknowledge that in making assumptions about provider behavior, no 
matter if required by law or well-supported by evidence, there will be 
those who will disagree with this type of approach to adjusting 
payment. We have addressed in the CY 2016 HH PPS final rule why we do 
not believe targeted program integrity efforts would mitigate 
behavioral changes resulting from a case-mix system (80 FR 68421). As 
we stated in the CY 2016 HH PPS final rule (80 FR 68421 through 68422), 
for a variety of reasons, we have not proposed targeted reductions for 
nominal case-mix growth, meaning the portion of case-mix growth that 
cannot be explained by changes in patient characteristics. The foremost 
reason is that we believe changes and improvements in coding have been 
widespread, so that such targeting would likely not separate agencies 
clearly into high and low coding-change groups. In that same rule, we 
referenced an independent review of our case-mix measurement 
methodology conducted by Dr. David Grabowski, Ph.D., a professor of 
health care policy at Harvard Medical School, and his team agreed with 
our reasons for not proposing targeted reductions, stating their 
concerns about the small sample size of many agencies and their 
findings of significant nominal case-mix across different classes of 
agencies (please see the ``Home Health Study Report--Independent Review 
of the Models to

[[Page 56456]]

Assess Nominal Case-Mix Growth'', dated June 21, 2011.) \12\
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    \12\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/HHPPS_HHAcasemixgrowthFinalReport.pdf.
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    While certain commenters seem to assume that CMS can precisely 
identify those agencies practicing abusive coding, we do not agree that 
agency specific case-mix levels can precisely distinguish the agencies 
that engage in abusive coding from all others. System wide, case-mix 
levels have risen over time throughout the country, while patient 
characteristics data indicate little real change in patient severity 
over time. That is, the main issue is not the level of case-mix billed 
by any specific HHA over a period of time, but the amount of change in 
the billed case-mix weights not attributable to underlying changes in 
actual patient severity. Therefore, while commenters provided specific 
suggestions for targeted efforts, we are unable to implement such 
actions for the reasons described. We note that we have taken various 
measures to reduce payment vulnerabilities and the federal government 
has launched actions to directly identify fraudulent and abusive 
activities. Commenters should be aware of tip lines available that can 
help support investigative efforts of the federal government. The 
Office of the Inspector General, Department of Health and Human 
Services website at: http://oig.hhs.gov/fraud/report-fraud/index.asp, 
provides information about how to report fraud. Another website, http://www.stopmedicarefraud.gov/index.html, is oriented to Medicare patients 
and their families and provides information about recognizing fraud.
    Finally, we remind commenters that section 1895(b)(3)(A)(iv) of the 
Act requires that in calculating a 30-day budget-neutral payment 
amount, we are required to make assumptions about behavior changes that 
could occur as a result of the implementation of the 30-day unit of 
payment and a change to the case-mix adjustment methodology; therefore, 
we do not have the discretion to apply different policies. Likewise, we 
are required to analyze data for CYs 2020 through 2026, after 
implementation of the 30-day unit of payment and the alternate case-mix 
adjustment methodology, to annually determine the impact of the 
differences between assumed behavioral changes and actual behavioral 
changes on estimated aggregate expenditures and adjust the payment 
amount either upwards or downwards accordingly.
    Comment: Several commenters disagreed with the three behavioral 
assumptions made and remarked that the assumptions appear to be 
randomly determined, inappropriate and that there is no evidence to 
support them. A commenter specifically stated that the assumptions lack 
any foundation in actual evidence-based data and therefore penalize 
providers in an arbitrary and capricious fashion in violation of the 
Administrative Procedures Act (APA). A few remarked that the 
assumptions are ``mere guesses'' and appear to be used solely to reduce 
home health payments. Other commenters remarked that the proposed 
behavioral assumptions appear to be overly complex and unsubstantiated. 
Some commenters stated the assumptions are illogical because the broad 
assumptions in the proposed rule basically construct a completely new 
payment system that is predicated on a presumption that HHAs will 
attempt to manipulate the system and recommended that the behavioral 
assumptions be tested before they are implemented. Many commenters 
asked for additional documentation on how the reductions derived from 
the three behavioral assumptions were calculated and wanted to know the 
specific calculations that were made and the rationale behind those 
calculations.
    Response: We disagree that the three behavioral assumptions made 
are arbitrary, inappropriate, illogical, mere guesses, overly complex, 
meant to penalize providers, or that there is no evidence to support 
them. Likewise, we disagree that these assumptions are in violation of 
the APA given that CMS is required by statute to apply behavioral 
assumptions in calculating the 30-day budget-neutral payment amount; we 
described such assumptions in notice and comment rulemaking as required 
by section 1895(b)(3)(A)(iv) of the Act. Additionally, we examined 
relevant data and believe we have a satisfactory explanation for these 
assumptions, including a substantive connection between the data and 
the behavioral assumptions made. We believe that there is both evidence 
for and precedent for adjusting the home health prospective payment 
based on assumed behavioral changes.
    With regards to our assumption that HHAs would code the highest-
paying diagnosis code as primary for the clinical grouping assignment, 
this assumption was based on decades of past experience under the case-
mix system for the HH PPS and other case-mix systems for other payment 
systems, such as the implementation of the diagnosis-related groups 
(DRGs) and the Medicare Severity (MS)-DRGs under the inpatient 
prospective payment system. In the FY 2008 IPPS final rule (72 FR 
47176), we noted that case-mix refinements can lead to substantial 
unwarranted increase in payments. To address this issue when CMS 
transitioned from DRGs to MS-DRGs, MedPAC recommended that the 
Secretary project the likely effect of reporting improvements on total 
payments and make an offsetting adjustment to the national average base 
payment amounts (72 FR 47176). In the FY 2008 IPPS final rule (72 FR 
47181), we summarized instances where case-mix increases resulted from 
documentation and coding-induced changes for the first year of the IRF 
PPS and in Maryland hospitals' transition to APR DRGs (estimated at 
around 5 percent in both instances). Therefore, we estimated that a 
total adjustment of 4.8 percent would be necessary to maintain budget 
neutrality for the transition to the MS-DRGs (72 FR 47178).
    In both the FY 2010 and FY 2011 IPPS final rules, subsequent 
analysis of claims data, using FYs 2008 and 2009 claims, supported the 
prospective payment adjustments to account for the documentation and 
coding effects (74 FR 43770 and 75 FR 50356). Specifically, we stated 
that based on our retrospective evaluation of claims, our actuaries 
determined that the implementation of the MS-DRG system resulted in a 
2.5 percent change and a 5.4 percent change in case-mix not due to 
actual changes in patient characteristics, but due to documentation and 
coding changes for discharges occurring during FYs 2008 and 2009, 
respectively. We stated that the coding assumption is appropriate 
because, in the absence of such adjustments, the effect of the 
documentation and coding changes resulting from the adoption of the MS-
DRGs results in inappropriately high payments because that portion of 
the increase in aggregate payments is not due to an increase in patient 
severity of illness (and costs).
    With regards to experience under the HH PPS, we note that effective 
for CY 2008, CMS finalized changes to the HH PPS case-mix model to 
reflect different resource costs for early home health episodes versus 
later home health episodes and expanded the case-mix variables and 
therapy thresholds included in the payment model (72 FR 49764). These 
changes resulted in the 153 home health resource groups (HHRGs) 
currently used to case-mix adjust payment in the HH PPS. Since the CY 
2008 proposed rule, we have stated in HH PPS rulemaking that we would 
continue to monitor case-mix

[[Page 56457]]

changes in the HH PPS and to update our analysis to measure change in 
case-mix, both nominal and real. As discussed in the CY 2010 HH PPS 
rule (74 FR 40958), the analysis then indicated approximately 9.77 
percent of the 15.03 percent increase in the overall observed case-mix 
between the IPS baseline and 2007 was real, that is, due to actual 
changes in patient characteristics. Our estimate was that a 13.56 
percent nominal increase (15.03-(15.03 x 0.0977)) in case-mix was due 
to changes in coding procedures and documentation rather than to 
treatment of more resource-intensive patients (that is, nominal case 
mix growth). In the CY 2011 HH PPS proposed rule, we stated from 2000 
to 2007, we observed about a 1 percent per year increase in total 
average case-mix. However, that annual change increased to slightly 
more than 4 percent [4.37 percent] between 2007 and 2008 (75 FR 43238). 
Our analyses at that time indicated a 19.40 percent increase in the 
overall observed case-mix since 2000 with approximately 10.07 percent 
attributed to actual changes in patient characteristics. Our estimate 
was that a 17.45 percent nominal increase (19.40-(19.40 x 0.1007)) in 
case-mix was due to changes in coding practices and documentation 
rather than to treatment of more resource-intensive patients. In the CY 
2012 HH PPS proposed rule we stated that our analysis indicated another 
large increase in the average case-mix weight between CY 2008 and CY 
2009 of 2.6 percent (76 FR 40990), attributable to the CY 2008 
refinements. Therefore, analysis of case-mix growth between the two 
years immediately after implementation of the CY 2008 refinements 
demonstrated that average case-mix increased by nearly 7 percent. Our 
latest analysis continues to support the payment adjustments as 
outlined in the CY 2018 HH PPS proposed rule (82 FR 35274), which shows 
that between CY 2000 and 2010, total case-mix change was 23.90 percent, 
with 20.08 considered nominal case-mix growth, an average of 
approximately 2 percent nominal case-mix growth per year, including 
changes due to the CY 2008 case-mix adjustment methodology refinements. 
Therefore, we believe that there is ample evidence supporting the 
behavioral assumptions relating to changes, including improvements, in 
coding.
    Our analysis shows that only about a third of 30-day periods move 
into a different clinical group as a result of the clinical group 
coding assumption, meaning that the reported secondary diagnosis(es) 
would place a period of care into a higher case-mix group under the 
PDGM if reported as the principal diagnosis. Clinically, there are 
circumstances in which it would be appropriate to report a higher 
paying code as the principal diagnosis. For example, if medical 
documentation notes that a patient was recently hospitalized for 
exacerbation of congestive heart failure (which, if reported as the 
principal diagnosis, would group a period of care into the clinical 
group, MMTA) and there is expected teaching by the HHA associated with 
the recent exacerbation, but the patient also has a stage 2 pressure 
ulcer (which, if reported as the principal diagnosis, would group a 
period of care into the clinical group, Wounds) that requires wound 
care, we believe it would be appropriate to report the pressure ulcer 
as the principal diagnosis as the pressure ulcer would likely take 
priority as the primary reason for home health care in terms of 
increased resource utilization. However, the teaching associated with 
the exacerbation of heart failure would be a secondary reason, but 
still an important additional reason for home health care, and 
congestive heart failure would be reported as an additional diagnosis 
on the home health claim. In the current HH PPS, the assignment of 
points as part of the clinical level in the case-mix methodology is 
dependent upon the reporting of diagnoses. However, the points assigned 
are not generally dependent on whether the diagnosis is reported as the 
primary diagnosis or other diagnosis, except for a few exceptions. This 
means, that for most of the clinical point assignments, the ordering of 
the diagnosis does not matter as much as whether the diagnosis is 
present or not. For example, if a cancer diagnosis is reported, there 
are the same number of associated clinical points regardless of whether 
the cancer diagnosis is reported as a principal diagnosis or as a 
secondary diagnosis. However, under the PDGM, the ordering of diagnoses 
is important in determining the clinical group and the comorbidity 
adjustment, so we do expect that HHAs will improve the ordering of 
diagnosis codes to ensure that the home health period of care is 
representative of patient characteristics and paid accordingly. 
Furthermore, the implementation of ICD-10-CM has expanded the diagnosis 
code set significantly, making it possible for HHAs to more accurately 
and specifically code conditions present in the home health patient 
population.
    With regards to the comorbidity coding assumption, using the home 
health claim for the comorbidity adjustment as opposed to OASIS 
provides more opportunity to report all comorbid conditions that may 
affect the home health plan of care. The OASIS item set only allows 
HHAs to designate up to 5 secondary diagnoses, while the home health 
claim (837I institutional claim format-electronic version of the paper 
UB-04) allows HHAs to report up to 24 secondary diagnoses. 
Additionally, because ICD-10 coding guidelines require reporting of all 
secondary diagnoses that affect the plan of care, we would expect that 
more secondary diagnoses would be reported on the home health claim 
given the increased number of secondary diagnosis fields on the home 
health claim compared to the OASIS item set. Therefore, we assume that 
by taking into account additional ICD-10-CM diagnosis codes listed on 
the home health claim, 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. Furthermore, because 
the comorbidity adjustment in the PDGM can increase payment by up to 20 
percent, we assume that HHAs will ensure that secondary diagnoses 
affecting the home health plan of care would be reported to more 
accurately identify the conditions affecting resource use.
    Regarding the LUPA threshold assumption, as noted in the FY 2001 HH 
PPS final rule, the episode file showed that approximately 16 percent 
of episodes would have received a LUPA (65 FR 41162). However, 
currently, only about 7 percent of all 60-day episodes receive a LUPA. 
In other words, it appears HHAs changed practice patterns such that 
more than half of 60-day episodes that would have been LUPAs upon 
implementation of the HH PPS are now non-LUPAs. Current data for CY 
2017 suggest that what would be about one-third of the LUPA episodes 
with visits near the LUPA threshold would move up to become non-LUPA 
episodes as we currently see clustering of episodes at and around the 
current LUPA threshold of 5 visits. Under the current 60-day episode 
structure, there is a natural breaking point in the distribution of 
episodes between those with 4 or fewer visits (LUPAs) and those with 5 
or more visits (non-LUPAs). The distribution around this breaking point 
of episodes as a percent of total episodes has remained fairly constant 
over the last few years. In particular, the episodes with 2, 3, or 4 
visits are similar, with each comprising about 2.4 percent of total 
episodes. Likewise, the

[[Page 56458]]

episodes with 5, 6, or 7 visits each represent about 4.6 percent of 
total episodes. We assume this same phenomenon will be observed in the 
PDGM, except that, to account for the different threshold structure, it 
will occur for periods that otherwise would be 1 or 2 visits away from 
becoming non-LUPA.
    We disagree with those commenters who state that the behavioral 
assumptions basically construct a completely new payment system that is 
predicated on gaming of the system. The goal of the proposed PDGM is to 
more accurately pay for home health services based on patient 
characteristics. As previously noted, section 1895(b)(3)(A)(iv) of the 
Act requires that behavioral assumptions be made in calculating the 
payment amount for CY 2020 so that the estimated aggregate amount of 
expenditures under the HH PPS in CY 2020 is equal to the estimate 
aggregate amount of expenditures in CY 2020 that otherwise would have 
been made under the HH PPS if the change to a 30-day unit of payment 
had not been enacted. Furthermore, we remind commenters that the law 
requires that CMS analyze data for CYs 2020 through 2026, after 
implementation of the 30-day unit of payment and the alternate case-mix 
adjustment methodology, to annually determine the impact of the 
differences between assumed and actual behavioral changes on estimated 
aggregate expenditures and adjust the payment amount either upwards or 
downwards accordingly. As such, we do not believe the law provides the 
latitude to test behavioral assumptions prior to implementation of the 
30-day unit of payment and the PDGM for CY 2020 given these 
requirements, in law, to make behavioral assumptions in calculating a 
30-day budget-neutral payment amount for CY 2020 and to determine the 
impact on estimated aggregate expenditures of differences between the 
assumed and actual behavior changes once the data for CYs 2020 through 
2026 become available to determine whether temporary and permanent 
adjustments are needed.
    We believe that, as described in the CY 2019 HH PPS proposed rule 
and throughout this final rule with comment period, we have provided 
sufficient detail for these behavioral assumptions as well as 
referenced past rules in which nominal case-mix change has been 
evaluated. The reconciliation process involving temporary and permanent 
adjustments required by law should assure HHAs that any over or 
underestimate of the payment amount will be adjusted accordingly. 
However, to support HHAs in evaluating the effects of the proposed 
PDGM, CMS provides, upon request, a Home Health Claims-OASIS Limited 
Data Set (LDS) to accompany the proposed and final rules. 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.
    Comment: In its public comments to the proposed CY 2019 HH PPS 
rule, MedPAC stated that the past experience of the home health PPS 
demonstrates that HHAs have changed coding, utilization, and the mix of 
services provided in reaction to new payment incentives. MedPAC 
remarked that CMS continued to find nominal increases in case mix 
unrelated to patient severity in later years and reduced payment by an 
average of 1.8 percent a year in 2008 through 2017 to account for this 
trend. MedPAC remarked that the proposed home health payment reduction 
of 6.42 percent appears to be consistent with past coding trends but 
that they do not expect that the reduction would create payment 
adequacy issues for most HHAs. As MedPAC has noted previously, the 
average margin of Medicare HHAs is 15.5%.
    Response: We thank MedPAC for their comments and we agree that 
there is sufficient evidence of HHA behavioral responses in reaction to 
payment incentives. We believe that HHA margins are adequate and that 
the 30-day budget-neutral payment amount should not cause revenue 
concerns for the majority of HHAs.
    Comment: Some commenters asked CMS to clarify their interpretation 
of the BBA of 2018 as it relates to budget neutrality. Specifically, 
Another commenter indicated that CMS should clarify that Congress 
intended to replace the existing budget neutrality requirement under 
the HH PPS with a temporary one-year budget neutrality requirement for 
CY 2020 that would be limited to maintaining equal aggregate 
expenditures associated with the transition between 60-day to 30-day 
units of service.
    Response: The law does not require CMS to replace the current 
budget neutrality requirements as set forth in section 1895(b)(3)(A) of 
the Act. However, 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. 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, 
the home health applicable percentage increase, the adjustment for 
case-mix changes, the adjustment if quality data is not reported, and 
the productivity adjustment. However, this does not mean that the 30-
day budget-neutral payment amount only pertains to payments made in CY 
2020 as we remind commenters that we are required to annually determine 
the impact of differences between assumed and actual behavior changes 
on estimated aggregate expenditures for CY 2020 through CY 2026 and 
adjust the payment amount upwards or downwards accordingly. Because we 
are proposing to implement the 30-day unit of payment and proposed PDGM 
for CY 2020, we would propose the actual 30-day payment amount in the 
CY 2020 HH PPS proposed rule calculated using CY 2018 home health 
utilization data, and we would calculate this amount before application 
of the proposed home health update percentage required for CY 2020 (as 
required by section 1895(b)(3)(B)(ii)(V) of the Act).
    Comment: Several commenters asked how CMS will make the 
reconciliation between assumed and actual behavioral changes upon 
implementation of the PDGM. A commenter indicated that CMS should fully 
display the reconciliation process with public notice and an 
opportunity to comment in advance of its application. Another commenter 
wanted to know if CMS would update its behavioral assumptions using CY 
2020 data to compare actual behavior to assumed behavior. Several 
commenters were concerned that CMS was placing a cap on the growth in 
home health services and in the event of growth, future payments would 
be reduced to match a payment amount from a prior year. A few 
commenters indicated that the behavioral assumptions are already 
accounted for in the current PPS and stated that HHAs already are 
incentivized to report the highest paying clinical diagnosis code on 
the claim, and also to develop and deliver plans of care that exceed 
the LUPA threshold.
    Response: We provided a detailed explanation as to how we 
calculated the 30-day budget-neutral payment amount in the CY 2019 HH 
PPS proposed rule (83 FR 32389) Specifically, we described how we 
calculated the budget-neutral 30-day payment amounts, both with and 
without behavioral assumptions and using CY

[[Page 56459]]

2019 payment parameters (for example, proposed 2019 payment rates, 
proposed 2019 case-mix weights, and outlier fixed-dollar loss ratio) to 
determine the expenditures that would occur under the current case-mix 
adjustment methodology. As with all elements of the PDGM, we would 
update the impacts of the proposed behavioral assumptions using CY 2018 
claims data in CY 2020 proposed rulemaking. This would be described in 
the CY 2020 HH PPS proposed rule to ensure HHAs are fully aware of the 
behavioral assumption impacts on the payment amount for CY 2020 using 
the most recent data available for CY 2020 implementation.
    In accordance with the BBA of 2018, we will annually determine the 
impact of differences between assumed behavior changes and actual 
behavior changes on estimated aggregate expenditures for CYs 2020 
through 2026. 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.
    In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our 
proposal to recalibrate the case-mix weights every year with more 
current data. Therefore, we refer commenters to previous HH PPS rules 
(for example, CY 2016 HH PPS final rule, (80 FR 68629)), where we 
recalibrate case-mix weights to account for nominal case-mix change. We 
anticipate a similar methodology when making any required permanent and 
temporary adjustments to payments, as required under sections 
1895(b)(3)(D)(ii) and (iii) of the Act, to address the impact of the 
assumed versus actual behavioral change after implementation of the 
PDGM and the 30-day budget-neutral payment amount. Section 
1895(b)(3)(D)(ii) of the Act requires notice and comment rulemaking for 
any permanent adjustments. Section 1895(b)(3)(D)(iii) of the Act 
similarly requires notice and comment rulemaking for any temporary 
adjustments. As a result, any reconciliation methodology for permanent 
and/or temporary adjustments would be subject to rulemaking, with the 
opportunity for the public to provide comments prior to the 
finalization of any policies. The data from CYs 2020 through 2026 will 
be available to determine whether temporary adjustments and/or 
permanent adjustments (increase or decrease) are needed no earlier than 
in years 2022 through 2028 rulemaking.
    We believe that the temporary and prospective adjustments outlined 
in the statute are not meant to act as a cap on overall home health 
expenditures. CMS is required by section of 1895(b)(3)(A)(iv) of the 
Act to calculate a 30-day payment amount for CY 2020 in a budget 
neutral manner so that estimated aggregate expenditures under the HH 
PPS during CY 2020 made under the new 30-day unit of payment would be 
equal to the estimated aggregate expenditures that otherwise would have 
been made in the absence of the 30-day unit of payment. Likewise, any 
permanent or temporary adjustments made, as required by the BBA of 
2018, would be made to address the impact of differences between 
assumed and actual behavior changes on estimated aggregate expenditures 
with respect to years beginning with 2020 and ending with 2026. Any 
adjustment to the payment amount resulting from differences between 
assumed versus actual behavior changes would not be related to 
increases in the number of beneficiaries utilizing Medicare home health 
services. The purpose of the required behavioral assumptions is to 
calculate the 30-day budget-neutral payment amount and not to limit 
payment for home health services or access to needed care.
    We disagree with comments that state that the behavioral 
assumptions made under the PDGM are already accounted for in the 
current HH PPS case-mix system given the assumptions made under the 
proposed PDGM are based on a shorter unit of payment, 30 days as 
opposed to the current 60 days. As described throughout this final rule 
with comment period and the proposed rule, the variation in resource 
utilization is most notable in the first versus second and subsequent 
30-day periods of care. Consequently, the behavioral assumptions are 
based on the 30-day unit of payment and the unique case-mix variables 
that are present under the PDGM, but not under the current HH PPS case-
mix system.
    Comment: A few commenters remarked that it would be difficult to 
change their behavior in response to the PDGM. For example, these 
commenters referenced the LUPA thresholds that vary by case-mix group 
and stated that these are difficult to understand and that it would be 
extremely difficult for a front line care provider to know for a 
specific patient whether they were close to a LUPA threshold.
    Response: As we have described in detail in the CY 2019 HH PPS 
proposed rule and other rules, the evidence supports a pattern of 
``practicing to the payment''. Specifically, there is ample evidence 
that there are notable behavior changes as they relate to payment 
thresholds. The findings from the Report to Congress on the ``Medicare 
Home Health Study: An Investigation on Access to Care and Payment for 
Vulnerable Patient Populations'', note that concerns have been raised 
about the use of therapy thresholds in the current HH PPS. Under the 
current payment system, HHAs receive higher payments for providing more 
therapy visits once certain thresholds are reached. As a result, the 
average number of therapy visits per 60-day episode of care have 
increased since the implementation of the HH PPS, while the number of 
skilled nursing and home health aide visits have decreased over the 
same time period as shown in Figure 3 of the CY 2018 HH PPS proposed 
rule (82 FR 35276). The study demonstrates that the percentage of 
episodes, and the average episode payment by the number of therapy 
visits for episodes with at least one therapy visit in 2013 increased 
sharply in therapy provision just over payment thresholds at 6, 7, and 
16. Similarly, between 2008 and 2013, MedPAC reported a 26 percent 
increase in the number of episodes with at least 6 therapy visits, 
compared with a 1 percent increase in the number of episodes with five 
or fewer therapy visits.\13\ CMS analysis demonstrates that the average 
share of therapy visits across all 60-day episodes of care increased 
from 9 percent of all visits in 1997, prior to the implementation of 
the HH PPS (see 64 FR 58151), to 39 percent of all visits in 2015 (82 
FR 35277). Furthermore, as noted in the FY 2001 HH PPS final rule, the 
episode file showed that approximately 16 percent of episodes would 
have received a LUPA (65 FR 41162). However, currently, only about 7 
percent of all 60-day episodes receive a LUPA. In other words, it 
appears HHAs changed practice patterns such that more than half of 60-
day episodes that would have been LUPAs upon implementation of the HH 
PPS are now non-LUPAs.
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    \13\ Medicare Payment Advisory Commission (MedPAC). ``Home 
Health Care Services.'' Report to Congress: Medicare Payment Policy. 
Washington, DC, March 2015. P. 223. Accessed on September 9, 2018 at 
http://www.medpac.gov/docs/default-source/reports/chapter-9-home-health-care-services-march-2015-report-.pdf?sfvrsn=0.
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    Therefore, past analysis confirms that there are noted changes in 
provider behavior resulting from the presence of thresholds that affect 
payment. As such, we believe that the presence of thresholds, 
regardless of whether they are therapy or LUPA thresholds, provides the 
incentive for providers to

[[Page 56460]]

adopt business practices that encourage the provision of visits to meet 
and exceed these thresholds to receive higher payment.
    Comment: A few commenters noted language in the FY 2019 Skilled 
Nursing Facility Prospective Payment System (SNF PPS) Final Rule (83FR 
39162), which included a payment and case-mix redesign known as the 
Patient-Driven Payment Model (PDPM) and noted that CMS declined to make 
any behavioral adjustments in the PDPM. These commenters stated that 
because the PDPM did not implement behavioral adjustments then the PDGM 
also should not implement behavioral adjustments.
    Response: We remind commenters that section 1895(b)(3)(A)(iv) of 
the Act requires CMS to make assumptions about behavior changes that 
could occur as a result of the implementation of the 30-day unit of 
payment and changes to the case-mix adjustment methodology when 
calculating the 30-day budget-neutral payment amount for CY 2020. 
Furthermore, as previously described in detail, we believe we have 
ample experience and data regarding changes in provider behavior made 
in response to payment changes that support the proposed behavioral 
assumptions. Additionally, the law requires us to annually determine 
the impact of differences between assumed and actual behavior changes 
on estimated aggregate expenditures for CY 2020 through CY 2026 and 
adjust the payment amount upwards or downwards accordingly. We will 
analyze any actual, observed behavioral changes with respect to CYs 
2020 through 2026 to make any payment adjustments beginning in CY 2022 
at the earliest.
    Comment: Some commenters indicated that the behavioral assumptions 
were too high and out of line with case-mix adjustments made in recent 
years. Commenters indicated that CMS should phase in reductions over 
multiple years if they exceeded a certain amount (for example, 2 
percent). Commenters indicated that adjustments should be based on 
actual behavior change and not based on assumed behavioral change. 
Several commenters recommended delaying implementation of the 
behavioral assumptions until actual data on provider behavior is 
available.
    Response: As detailed throughout this final rule with comment 
period, we believe there is sufficient evidence supporting the 
behavioral assumptions and payment impacts. Therefore, we disagree that 
the impacts of the assumptions are too high or not in alignment with 
previous analysis of nominal case-mix growth. Likewise, MedPAC 
commented that they believe the 6.42 percent reduction to the payment 
amount from the behavioral assumptions was appropriate and does not 
expect that this percent reduction would create payment adequacy issues 
for most HHAs.
    We acknowledge that there have been previous phase-ins of other 
payment adjustments to account for nominal case mix growth. We remind 
commenters that the statute requires that in calculating the 30-day 
budget-neutral payment amount, for home health units of service 
furnished that end during the 12-month period beginning January 1, 
2020, the Secretary shall make assumptions about behavior changes that 
could occur as a result of the implementation of a 30-day unit of 
payment and the alternate case-mix adjustment methodology. Therefore, 
we do not have the discretion to implement a different policy. However, 
because the statute requires that we must 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, and to make payment amount 
adjustments accordingly, we believe there is already a mechanism in 
place to assure HHAs that payment amount will be adjusted to accurately 
account for actual behavior.
    We remind commenters that the 30-day unit of payment and the PDGM 
will not be implemented until CY 2020 and CMS will analyze claims data 
from CY 2018 to determine any changes to the payment amount for CY 2020 
and will propose the amount in the CY 2020 HH PPS proposed rule. 
Finally, we are required to make the adjustments at a later date when 
we have actual data. Therefore, we can ensure that the 30-day payment 
amounts are set at the level they would have been had changes in case 
mix due to behavior adjustments been known. Therefore, we do not 
believe it is necessary to phase-in the impacts of the behavioral 
assumptions. By providing updated analysis and payment rates in the CY 
2020 HH PPS proposed rule, this will allow stakeholders additional 
opportunity to comment on the behavioral assumption impacts. While many 
commenters wanted CMS to delay implementation of the behavioral 
assumption impacts until actual data are available, CMS is required 
under section 1895(b)(3)(A)(iv) of the Act to take into account 
behavior changes that could occur as a result of the implementation of 
a 30-day unit of payment and the case-mix adjustment factors that are 
implemented in CY 2020 when calculating the 30-day budget neutral 
payment amount for CY 2020. Deferring until actual data are available 
would delay implementation of the behavioral assumption impacts until 
CY 2022, which would not meet the requirements of the statute. Data 
from CY 2020 to 2026 will be available to determine whether temporary 
or permanent adjustments to the payment amounts are needed.
    Comment: Several commenters encouraged CMS to closely monitor 
utilization patterns, billing trends, and other associated behaviors 
following implementation of the PDGM, to ensure that beneficiary access 
is not negatively impacted as a result of the new case-mix system, 
particularly the switch from a 60-day episode to a 30-day unit of 
payment. There was also concern that agencies may inappropriately 
extend 30-day periods that previously would have ended within 30 days 
in order to receive additional payment. There were other commenters who 
indicated that 30-day periods would cause beneficiaries to be 
discharged from home health earlier than they otherwise would be. Some 
commenters were concerned that certain visits would be frontloaded 
under a 30-day system as opposed to being spread out over a longer 
period of time, whereas another commenter indicated that have a 30-day 
period would discourage frontloading.
    Response: The goal of the PDGM is to more accurately align payment 
with the cost of providing care and is not meant to penalize or harm 
providers or beneficiaries. We recognize that changes in payment 
generally have an effect on the provision of services and we believe we 
have accounted for those assumed behavioral changes in calculating the 
30-day budget-neutral payment amount. To address concerns regarding 
patient access and safety, we remind commenters that the home health 
CoPs are to help ensure the health and safety of Medicare 
beneficiaries. The home health CoPs have requirements as they relate to 
the content of the plan of care. Specifically, the CoPs at Sec.  484.60 
state that the individualized plan of care must specify the care and 
services necessary to meet the patient-specific needs as identified in 
the comprehensive assessment, including identification of the 
responsible discipline(s), and the measurable outcomes that the HHA 
anticipates will occur as a result of implementing and coordinating the 
plan of care. Services must be furnished in accordance with accepted 
standards of practice. Therefore, upon implementation of the PDGM, we 
expect that HHAs will

[[Page 56461]]

continue to provide the services in accordance with the existing 
requirements. As such, we would not expect HHAs to inappropriately 
discharge home health patients or extend unnecessary home health 
services.
    CMS does not intend to prescribe how home health agencies provide 
care to their patients. As reiterated throughout this section, services 
provided, including the disciplines providing the care and the 
frequency of those services, are done so in accordance with an 
individualized plan of care, established and periodically reviewed by 
the certifying physician. We recognize that some beneficiaries may 
benefit from the frontloading of visits and there has been research to 
indicate that the frontloading of skilled visits is beneficial to some 
patients and may reduce hospitalization.\14\ However, there may be 
other beneficiaries that may benefit from visits that are provided over 
a longer period of time. In accordance with the plan of care 
requirements at Sec.  484.60, we expect the provision of services to be 
made to best meet the patient's care needs. After implementation of the 
PDGM and a change to the 30-day unit of payment, CMS will closely 
monitor utilization patterns, beneficiary impact and provider behavior 
to see if any refinements to the PDGM are warranted, or if any concerns 
are identified that may signal the need for appropriate program 
integrity measures.
---------------------------------------------------------------------------

    \14\ O'Connor M, Bowles KH, Feldman PH, St Pierre M, 
Jarr[iacute]n O, Shah S, Murtaugh CM. Frontloading and intensity of 
skilled home health visits: A state of the science. Home Health Care 
Services Quarterly. 2014; 33(3):159-75. doi: 10.1080/
01621424.2014.931768.
---------------------------------------------------------------------------

    Comment: MedPAC recommended that CMS include an additional 
behavioral assumption to account for responses to the shorter unit of 
payment that would result in increased aggregate payments (that is, 
HHAs changing visit patterns such that instead of having a single 30-
day period of care, they would provide just enough visits to get 
payment for a second 30-day period of care).
    Response: Public comments received in response to both the CY 2018 
and CY 2019 HH PPS proposed rules presented conflicting predictions 
regarding anticipated provider behavior in response to the timing 
element of the PDGM with regards to 30-day periods of care. Several 
commenters stated that they expected providers to discharge patients 
after the first 30-days of care given that the case-mix weights are, on 
average, higher for the first 30-days of care. Other commenters 
expressed concern that providers may attempt to keep home health 
beneficiaries on service for as long as possible. We do not believe is 
it necessary to add any additional behavioral assumptions at this time 
and we note that CMS is required to make future payment amount 
adjustments based on the difference between assumed and actual 
behavioral changes.
    Comment: A couple of commenters raised the question of whether CMS 
removed LUPA payments from the numerator when calculating the budget-
neutral 30-day payment amount with and without behavioral assumptions.
    Response: CMS did not remove the LUPA payments from the numerator 
when calculating the budget-neutral 30-day payment amounts. Including 
LUPA payments provides a broader picture when looking at impacts. In 
order to calculate the 30-day budget-neutral payment amount, both with 
and without the behavioral assumptions, we first calculated the total, 
aggregate amount of expenditures that would occur under the current 
case-mix adjustment methodology. Because estimated aggregate 
expenditures under the 30-day unit of payment must be budget neutral to 
estimated aggregate expenditures made if the 30-day unit of payment was 
not implemented, we must look at the aggregate payments made under the 
current HH PPS. This means we must look at all payments made, including 
LUPA payments.
    Comment: Another commenter indicated that according to CMS' 2017 
Fee-for-Service Supplemental Improper Payment Data report, the 
projected amount of improper payments made to HHAs for incorrect coding 
was $0 and that this zero dollar figure stands in stark contrast to 
CMS' assumption that all HHAs will use improper codes to bill Medicare 
for higher payments under PDGM. Conversely, other commenters indicated 
that the behavioral assumptions will cause a perverse incentive to 
``upcode'' when previously agencies wouldn't have engaged in this 
practice.
    Response: CMS uses the Comprehensive Error Rate Testing (CERT) 
Program to estimate the Medicare Fee-For-Service (FFS) improper payment 
rate. The purpose of the CERT Program is to identify payments that 
should not have been made or payments made in an incorrect amount. 
Specifically, ``improper payments'' include: Both overpayments and 
underpayments; payments to an ineligible recipient; payments for an 
ineligible service duplicate payments; payments for services not 
received; or, payments for an incorrect amount. Conversely, as we have 
noted throughout this section, the purpose of the behavioral 
assumptions is to take into account assumed behavioral changes 
resulting from a change in the unit of payment from 60 to 30 days and 
the change to the case-mix adjustment methodology in order to calculate 
a 30-day budget neutral prospective payment amount, and not to 
determine whether improper payments were or will be made. We have also 
stated that the purpose of the behavioral assumptions is not to be 
punitive or to indicate that HHAs are engaging in unethical or 
inappropriate behavior, but to anticipate those behavioral changes when 
calculating a prospective payment. We expect coding changes to occur 
given the expansion of the ICD-10 code set and the PDGM using the 
diagnoses reported on the claim as opposed to the OASIS. This provides 
HHAs with an opportunity to report conditions supported in the medical 
documentation for which home health services are being provided. We 
remind commenters that ``upcoding'' is a fraudulent billing practice 
where a healthcare provider assigns an inaccurate billing code to a 
medical procedure or treatment to increase payment and where the actual 
service(s) provided are not supported by the codes reported. We do not 
view reporting diagnoses that are supported in the medical 
documentation and which reflect the home health care and services 
provided to be ``upcoding''. We do expect, however, that HHAs will 
establish the individualized plan of care in accordance with the needs 
identified in the initial and comprehensive assessments to address all 
pertinent and supported diagnoses.
    Final Decision: We are finalizing the three behavioral assumptions 
as previously described in calculating a 30-day budget-neutral payment 
amount. We will update the CY 2020 30-day budget-neutral payment amount 
in the CY 2020 proposed rule using the most recent data available.
c. Split Percentage Payment Approach for a 30-Day Unit of Payment
    In the current HH PPS, there is a split percentage payment approach 
to the 60-day episode. 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.

[[Page 56462]]

    The BBA of 2018 requires a change to the unit of payment from a 60-
day episode to a 30-day period of care, effective January 1, 2020. As 
described in the CY 2018 HH PPS proposed rule (82 FR 35270) and in the 
CY 2019 HH PPS proposed rule (83 FR 32391), we believe that as a result 
of the reduced timeframe for the unit of payment, that a split 
percentage approach to payment may not be needed for HHAs to maintain 
adequate cash flow. Currently, about 5 percent of requests for 
anticipated payment are not submitted until the end of a 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. As such, we are reevaluating the 
necessity of RAPs for existing and newly-certified HHAs versus the 
risks they pose to the Medicare program.
    In the CY 2019 HH PPS proposed rule, we described in detail, 
potential program integrity vulnerabilities as they relate to RAP 
payments (83 FR 32391). We stated that given the program integrity 
concerns and the reduced timeframe for the unit of payment (30 days 
rather than 60 days), we proposed not to allow newly-enrolled HHAs, 
that is HHAs certified for participation in Medicare effective on or 
after January 1, 2019, to receive RAP payments beginning in CY 2020. We 
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.
    We proposed that existing HHAs, that is HHAs certified for 
participation in Medicare with effective dates prior to January 1, 
2019, would continue to receive RAP payments upon implementation of the 
30-day unit of payment and the proposed PDGM case-mix adjustment 
methodology in CY 2020.
    We solicited comments as to whether the split payment approach 
would still be needed for HHAs to maintain adequate cash flow if the 
unit of payment changes from 60-day episodes to 30-day periods of care 
under our proposal. In addition, we solicited comments on ways to 
phase-out the split percentage payment approach in the future. 
Specifically, we solicited comments on reducing the percentage of the 
upfront payment over a period of time. We also solicited comments on 
requiring for HHAs to submit a notice of admission within 5 days of the 
start of care to alert the claims processing system that a beneficiary 
is under a home health period of care, if in the future the split 
percentage approach was eliminated. to assure being established as the 
primary HHA for the beneficiary and so that the claims processing 
system is alerted that a beneficiary is under a HH period of care to 
enforce the consolidating billing edits required by law.
    The following is a summary of the public comments received on the 
``Split Percentage Payment Approach for a 30-day Unit of Payment'' 
proposal and our responses:
    Comment: Many commenters supported all or parts of CMS's changes to 
the RAP policy. Some commenters indicated that the elimination of the 
split percentage would align better with a 30-day payment and would 
simplify claims submission. Other commenters stated they do not want 
any type of phase-out of RAPs and remarked that RAPs should continue 
under the PDGM to ensure no disruption in cash flow. There was some 
commenter support to phase out the split percentage payment over a 
multi-year period starting at least one year after the implementation 
of the PDGM in order to allow agencies to adapt to PDGM. Some 
commenters indicated that RAPs for late periods could be phased out, 
but that RAPs for early periods should remain in place to ensure an 
upfront payment for newly admitted home health patients. Some 
commenters supported the reduction in the split percentage payment but 
wanted to allow RAPs for newly enrolled HHAs.
    Response: We thank commenters for their careful review and 
suggestions regarding the proposals regarding a potential phase-out of 
RAPs. We continue to believe that as a result of a reduced timeframe 
for the unit of payment from a 60-day episode to a 30-day period, that 
a split percentage approach to payment may not be needed for HHAs to 
maintain an adequate cash flow. We also believe that by eventually 
phasing-out the submission of RAPs with each 30-day period, that this 
will significantly streamline claims processing for HHAs. Likewise, by 
eliminating RAP payments for newly-enrolled HHAs, we believe this would 
allow these HHAs to structure their operations without becoming 
dependent on a partial advanced payment and take advantage of receiving 
full payments every 30 days. We will continue to monitor the need for 
RAPs after the implementation of the PDGM. We understand that HHAs may 
need time to adapt to the PDGM so any phase-out of RAP payments for 
existing HHAs would be addressed in future rulemaking.
    Comment: Many commenters had concerns that CMS was modifying its 
RAP policy due to abuse by certain agencies. Commenters suggested that 
CMS should utilize their ability to restrict RAPs for agencies that 
abuse it instead of modifying the current RAP policy. Some commenters 
indicated that not all cases where a final claim isn't submitted after 
a RAP are abusive. Commenters encouraged CMS to identify the agencies 
that are abusing the system and to impose more oversight through 
accrediting organizations and the MACs.
    Response: While one of the reasons for the elimination of the RAP 
is to potentially stem program integrity vulnerabilities, it is not the 
sole reason. We remind commenters that the current median length of 
days for RAP submission is 12 days from the start of the 60-day 
episode. With a change to a 30-day unit of payment, if this median 
length of days for RAP submissions remains constant, there is the 
possibility that HHAs could be simultaneously submitting a RAP and a 
final claim for each 30-day period of care. We believe that this 
defeats the purpose of the RAP to maintain adequate cash flow and only 
increases complexity for HHAs in their claims processing. With monthly 
billing, HHAs have the ability to receive an ongoing cash flow which we 
believe would mitigate concerns over having adequate funds for the 
provision of care.
    We acknowledge and appreciate the concerns commenters have with 
regards to abuse of the RAP policy by certain HHAs. We plan to continue 
to closely monitor RAP submissions, service utilization, payment, and 
quality trends which may change as a result of implementing of the PDGM 
and a 30-day unit of payment. If changes in practice and/or coding 
patterns or RAPs submissions arise, we may take further action, which 
may include administrative action against providers as appropriate and/
or proposing changes in policy. We will also continue to work with the 
HHS Office of Inspector General in case any cases of provider abuse are 
identified.
    We would like to reiterate that in the CY 2019 HH PPS proposed 
rule, we proposed existing HHAs, that is HHAs that are certified for 
participation in Medicare with effective dates prior to January 1, 
2019, would continue to receive RAP payments upon implementation of the 
PDGM in CY 2020. Only newly-enrolled HHAs, that is HHAs certified for 
participation in Medicare effective on or after January 1, 2019, would 
not receive RAP payments beginning in CY 2020.
    Comment: Several commenters believe that newly enrolled HHAs have 
the same or more cash flow concerns as

[[Page 56463]]

existing HHAs and that split-percentage payments should also be made to 
newly enrolled HHAs. Some commenters expressed concern about HHAs 
acquired or opened on or after January 1, 2019 under a HHA chain 
organization and whether these newly enrolled HHAs that are part of a 
chain would be ``grandfathered'' in and would be allowed to receive RAP 
payments beginning in CY 2020. These commenters remarked that not 
allowing these HHAs to be grandfathered in would disrupt operations.
    Response: While we appreciate commenter concerns, in the CY 2019 HH 
PPS proposed rule, when referring to not allowing newly-enrolled HHAs 
(that is, those certified for Medicare participation effective on or 
after January 1, 2019) to receive RAP payments beginning in CY 2020, we 
did not distinguish between solely-owned HHAs and HHAs that are owned 
by a parent or chain company. For payment purposes, a CMS Certification 
Number (CCN) is required to be included on the Medicare claim and the 
RAP. Upon Medicare enrollment, a CCN is issued. This policy is 
applicable to newly enrolled HHAs and thus this policy would apply to 
those HHAs with a CCN that is effective on and after January 1, 2019, 
regardless of whether they are solely-owned or owned by a patent or 
chain company. We believe that having the opportunity to receive full 
payment every 30 days may mitigate cash flow concerns for newly 
enrolled HHAs.
    Comment: Some commenters expressed support for the Notice of 
Admission (NOA) and recognized that the NOA would be necessary to alert 
the claims processing system of a home health period of care because of 
the consolidated bulling requirements. Other commenters opposed the use 
of a NOA and the requirement to submit a NOA within 5 days of the home 
health start of care. These commenters referenced some of the 
operational and processing issues with the hospice Notice of Election 
and expressed concern that there could be delay in needed care. Other 
questioned the burden associated with a NOA process.
    Response: We remind commenters that existing HHAs, meaning those 
certified for participation in Medicare with effective dates prior to 
January 1, 2019, would continue with the same RAP submission process as 
they currently follow under the current HH PPS except that a RAP would 
have to be submitted at the beginning of each 30-day period of care. 
Likewise, we proposed that newly-enrolled HHAs (that is, those 
certified for participation in Medicare effective on and after January 
1, 2019) would have 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. RAP submissions are significant as the RAP 
establishes the HHA as the primary HHA for the beneficiary during the 
timeframe and alerts the claims processing system that the beneficiary 
is under the care of the HHA. A Notice of Admission (NOA) would only be 
required if the split-percentage payment approach is eliminated in the 
future. However, we did not propose to eliminate RAP payments for 
existing providers and newly-enrolled providers would only have to 
submit a ``no-pay'' RAP in order to establish a home health period of 
care within the claims processing system. If we do propose elimination 
of the split-percentage approach, we would do so in future rulemaking 
and would solicit comments at that time about the process that would be 
established in regards to the submission of a Notice of Admission.
    Final Decision: We are finalizing the split-percentage proposal as 
proposed with an effective date of January 1, 2020. This means that 
newly-enrolled HHAs, that is HHAs certified for participation in 
Medicare effective on or after January 1, 2019, would not receive RAP 
payments beginning in CY 2020. 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. Existing HHAs, meaning those HHAs that are 
certified for participation in Medicare effective prior to January 1, 
2019, will continue to receive RAP payments upon implementation of the 
PDGM in CY 2020. For split-percentage payments to be made, 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, 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. We are also 
finalizing the corresponding regulations text changes as described in 
section III.F.13 of this final rule with comment period related to the 
split percentage payment approach.
4. Timing Categories
    In the CY 2019 HH PPS proposed rule, we described analysis showing 
the impact of timing on home health resource use and proposed to 
classify the 30-day periods under the proposed PDGM as ``early'' or 
``late'' depending on when they occur within a sequence of 30-day 
periods. For the purposes of defining ``early'' and ``late'' periods 
for the PDGM, we proposed that only the first 30-day period in a 
sequence of periods be defined as ``early'' and all other subsequent 
30-day periods would be considered ``late''. Additionally, we proposed 
that the definition of a ``home health sequence'' (as currently 
described in Sec.  484.230) would remain unchanged relative to the 
current system; that is, 30-day periods are considered to be in the 
same sequence as long as no more than 60 days pass between the end of 
one period and the start of the next, which is consistent with the 
definition of a ``home health spell of illness'' described at section 
1861(tt)(2) of the Act. We further noted that because section 
1861(tt)(2) of the Act is a definition related to eligibility for home 
health services as described at section 1812(a)(3) of the Act, it does 
not affect or restrict our ability to implement a 30-day unit of 
payment.
    We solicited public comments on the timing categories under the 
proposed PDGM and the associated regulations text changes discussed in 
section III.F.13 of the proposed rule. The following is a summary of 
the public comments received and our responses:
    Comment: Several commenters supported the inclusion of the timing 
category in the PDGM, stating that this differentiation reflects that 
HHA costs are typically highest during the first 30 days of care and 
supports HHA efforts to follow clinical evidence on the importance of 
``frontloading'' resources in the home care setting in order to 
facilitate improved patient outcomes.
    Response: We appreciate the commenters' support regarding the 
inclusion of the timing element within the PDGM framework, as we 
believe that the early and late designations will serve to better align 
payments with the existing resource use pattern observed in home health 
data. The utilization of increased resources in early periods is 
demonstrated in the data analyzed during the development of the PDGM, 
as described in the CY 2019 HH PPS proposed rule (83 FR 32340). We 
believe that ultimately this component of the PDGM will help to account 
for the increase in intensity of resources often required at the start 
of home health care.
    Comment: Several commenters expressed concern regarding the change 
in the definition of ``early'' and ``late'' 30-day periods from the 
current payment model, stating that many patients need more than 30 
days of intense care due to their medically

[[Page 56464]]

complex, chronic conditions and their multiple, serious diagnoses 
requiring skilled assessment and interventions. The commenters asserted 
that HHAs may ration care to those beneficiaries in ``late'' 30-day 
periods and that the new timing category would serve to penalize those 
HHAs that do enroll clinically-complex beneficiaries with ongoing care 
needs. Several commenters stated that categorizing 30-day home health 
periods into ``early'' and ``late'' would serve to ``devalue'' later 
care during a home health period of care. A commenter also stated that 
categorizing only the first 30 days as ``early'' would potentially put 
beneficiaries at risk because they state that more costly therapy 
services become most appropriate as a beneficiary begins to stabilize, 
which the commenter stated typically occurs around week three of a home 
health care. Another commenter also stated that caregiver availability 
also varies in the weeks following an acute event, with support 
diminishing in the weeks following admission to home health, leading to 
an increased need for additional support during those 30-day periods 
that would now be categorized as ``late.'' Several commenters expressed 
concern that the definition of the ``late'' category would not account 
for any additional costs that would be associated with a new set of 
resource-intensive health needs for a patient that may occur after the 
``early'' 30-day period.
    Response: As described in detail in the CY 2019 HH PPS proposed 
rule, our proposal regarding the timing element of the PDGM was 
intended to refine and to better fit costs incurred by agencies for 
patients with differing characteristics and needs under the HH PPS (83 
FR 32340). The resource cost estimates are derived from a very large, 
representative dataset. Therefore, we expect that the proposal reflects 
agencies' average costs for all home health beneficiaries, including 
medically-complex patients with ongoing needs. We have constructed the 
revised payment model based upon the actual resources expended by home 
health agencies for Medicare beneficiaries, which show that typically 
HHAs provide more visits during the first 30 days of care and utilize 
less resources thereafter. We reiterate that the timing categories are 
reflective of the utilization patterns observed in the data analyzed 
for the purposes of constructing the PDGM, and we have not manipulated 
the resource utilization or weighting to encourage certain patterns of 
care for the first 30-day period within the PDGM. The weights of the 
two timing categories are driven by the mix of services provided, the 
costs of services provided as determined by cost report data, the 
length of the visits, and the number of visits provided. The 
categorization of 30-day periods as ``early'' and ``late'' serves to 
better align payments with already existing resource use patterns. This 
alignment of payment with resource use is not to be interpreted as 
placing a value judgment on particular care patterns or patient 
populations.
    Additionally, in our CY 2008 HH PPS final rule, we implemented an 
``early'' and ``late'' distinction in the HH PPS in which the late 
episode groupings were weighted more heavily than those episodes 
designated as early due to heavier resource use during later episodes 
(72 FR 49770). At that time, commenters expressed concerns that this 
heavier weighting for later episodes could lead to gaming by providers, 
with patients on service longer than would be appropriate, and that 
providers may not discharge patients when merited. During our analysis 
in support of subsequent refinements to the HH PPS in 2015, as 
described in the CY 2015 HH PPS proposed rule (79 FR 38366), we 
analyzed the utilization patterns observed in the CY 2013 claims data 
and observed that the resource use for later episodes had indeed 
shifted such that later episodes had less resource use than earlier 
periods, which was the opposite of the pattern observed prior to CY 
2008. Furthermore, in its 2016 Report to Congress, MedPAC noted that, 
between 2002 and 2014, a pattern in home health emerged where the 
number of episodes of care provided to home health beneficiaries 
trended upwards, with the average number of episodes per user 
increasing by 18 percent, rising from 1.6 to 1.9 episodes per user.\15\ 
MedPAC noted that this upward trajectory coincided with, among other 
changes, higher payments for the third and later episodes in a 
consecutive spell of home health episodes. Given the longitudinal 
variation in terms of resource use during home health episodes, we 
believe that restricting the ``early'' definition to the first 30-day 
is most appropriate for this facet of the PDGM. Our analysis of home 
health resource use, our review of the literature on ``frontloading,'' 
as well as comments from the public that confirm that more resources 
are used in the first 30 days, provide compelling evidence to limit the 
definition of early to the first 30-day period. As we receive and 
evaluate new data related to utilization patterns in Medicare home 
health care, specifically under the PDGM, we will reassess the 
appropriateness of the payment levels for ``early'' and ``late'' 
periods in a sequence of periods, and we will evaluate whether changes 
are needed once the model has been implemented.
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    \15\ http://www.medpac.gov/docs/default-source/reports/chapter-8-home-health-care-services-march-2016-report-.pdf.
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    Comment: Several commenters described concerns regarding the 
potential for problematic provider behavior due to financial 
incentives. Several commenters stated that the timing element of the 
PDGM has the potential to create an incentive to increase overall 
patient volume, to discourage providers from accepting community 
referrals, to extend home health lengths of stay so as to include at 
least two 30-day periods, and to promote lower quality home health care 
in order to maximize reimbursements. Several commenters stated that the 
timing variable in the PDGM payment model would increase the incentive 
to prematurely discharge patients while other commenters stated that 
the timing variable may incentivize HHAs to avoid patients who require 
care over the span of multiple periods of care.
    Response: We fully intend to monitor provider behavior in response 
to the new PDGM. As we receive and evaluate new data related to the 
provision of Medicare home health care under the PDGM, we will reassess 
the appropriateness of the payment levels for ``early'' and ``late'' 
periods in a sequence of periods. Additionally, we will share any 
concerning behavior or patterns with the MACs and/or other program 
integrity contractors. We plan to monitor for and identify any 
variations in the patterns of care provided to home health patients, 
including both increased and decreased provision of care to Medicare 
beneficiaries. We note that an increase in the volume of Medicare 
beneficiaries receiving home health care may, in fact, represent a 
positive outcome of the PDGM, signaling increased access to care for 
the Medicare population, so long as said increase in volume of 
beneficiaries is in keeping with eligibility guidelines for the 
Medicare home health benefit.
    Moreover, the public comments we received in response to both the 
CY 2018 and CY 2019 HH PPS proposed rules presented conflicting 
predictions regarding anticipated provider behavior in response to the 
implementation of the PDGM. Several commenters stated that they 
expected providers to discharge patients after the first 30-days of 
care given that the case-mix weights are, on average, higher for the 
first 30-days of care. Other commenters expressed

[[Page 56465]]

concern that providers may attempt to keep home health beneficiaries on 
service for as long as possible. We note the PDGM case-mix weights 
reflect existing patterns of resource use observed in our analyses of 
home health claims data. Since we proposed to recalibrate the PDGM 
case-mix weights on an annual basis to ensure that the case-mix weights 
reflect the most recent utilization data available at the time of 
rulemaking, future recalibrations of the PDGM case-mix weights may 
result in changes to the case-mix weights for early versus late 30-day 
periods of care as a result of changes in utilization patterns. 
Finally, we expect that HHAs will furnish care in accordance with each 
beneficiary's HH plan of care as required by the HH CoPs at Sec.  
484.60.
    Comment: Several commenters requested that we modify the definition 
of an ``early'' 30-day period to either the first two 30-day periods or 
the first four 30-days of care, stating that those definitions would 
more closely mirror the current payment system's definition of 
``early'' and that HHAs would otherwise experience a payment decrease 
when compared to the current 60-day episode payment amount because of 
the differentiated payment amounts for ``early'' and ``late'' 30-day 
periods. The commenters also stated that there is concern that the PDGM 
definitions of ``early'' and ``late'' may hurt agencies due to the 
decrease in overall payment because of the lower reimbursement for 
periods categorized as ``late.'' Another commenter stated that the PDGM 
inaccurately ties payment to time in home health care, with very little 
regard to actual care needs.
    Response: With regard to a potential reduction in overall payment 
due to the revised designations of ``early'' and ``late'' periods under 
the PDGM, as we described in the CY 2019 HH PPS proposed rule, our 
analysis of the related data indicates that there is significant 
difference in the resource utilization between early and late 30-day 
periods as demonstrated in Table 34 of the proposed rule (83 FR 32392). 
One of the driving goals in the development of the PDGM was to better 
align payments with costs incurred by agencies for patients with 
differing characteristics and needs under the HH PPS. We continue to 
believe that a PDGM that accounts for the actual, demonstrated increase 
in resource utilization in the first 30-day period better captures the 
variations in resource utilization. We believe that the PDGM further 
promotes the goal of payment accuracy within the HH PPS and Medicare 
overall. However, we note that we will continue to monitor for any 
changes in trends as evidenced by home health data reflecting the 
change to the HH PPS and make modifications to the PDGM as necessary.
    Comment: Several commenters suggested that we revise the payment 
model such that a readmission to home health within the 60-day gap 
period results in an ``early'' instead of a ``late'' 30-day period. 
They suggested that we should consider altering the definition of 
sequences of 30-day periods to include home health re-admissions 
following acute institutionalization as a condition of determining a 
new sequence of home health periods of care, in addition to the 60-day 
gap in home health services, stating that this would be akin to the 
proposal defining admission source for the purposes of determining 
institutional payment status.
    Response: We appreciate the commenter's suggestion regarding the 
consideration of a readmission to home health within the 60-day gap be 
treated as an ``early'' stay. However, we note that the PDGM also 
includes a category for source of admission, which would account for a 
readmission to home health within 14 days of an acute care hospital 
stay. The admission source category is discussed in detail in Section 
III.E.5 of this final rule with comment period. Under the PDGM we 
already account for the differentiating features of institutional 
stays, including inpatient stays that occur within 14 days of the 
commencement of a home health period. Our proposal was intended to 
refine and to better fit costs incurred by agencies for patients with 
differing characteristics and needs under the prospective payment 
system. Therefore, we expect that the addition of both the source of 
admission as well as the timing categories would reflect agencies' 
average costs for home health patients. We believe that crafting a 
multi-pronged model, which includes adjustments based both on timing 
within a home health sequence as well as the source of the 
beneficiary's admission, will serve to more accurately account for 
resources required for Medicare beneficiaries and similarly provide a 
differentiated payment amount for care.
    Comment: A commenter stated that the timing categories create 
disincentives for home health care providers to prevent hospital 
readmissions because a resumption of care would then generate higher 
revenues. Another commenter stated that HHAs often front load visits 
post hospitalization or admission to a SNF, including the ``resumption 
of care period.'' The commenter expressed concern that the proposed 
timing categories for the PDGM do not capture the resources required 
for a resumption of care and asks that we expand the definition of 
sequencing of ``early'' periods to include home health readmissions 
following acute hospital or SNF stays.
    Response: For the purposes of the timing category of the PDGM, an 
intervening hospital stay would not trigger re-categorization to an 
``early'' 30-day period of care unless there was more than a 60-day gap 
in home health care. Therefore, we do not believe that the timing 
element of the PDGM would create a financial incentive to 
inappropriately encourage the admission of home health patients to an 
acute care setting in order to receive a subsequent home health 
referral in the higher-paid ``early'' category. Additionally, we note 
that the admission source category within the PDGM serves to capture 
the increased resource needs in the home health population referred 
from an inpatient hospital stay, occurring within 14 days of home 
health admission, creating differentiated case-mix weights that align 
payment with the resource use for that subpopulation of home health 
beneficiaries.
    Comment: Several commenters expressed concern regarding the 
operational aspects of the timing element of the PDGM. Another 
commenter asked how patient transfers would be addressed, asserting 
that the second agency should not receive lower payment if they were 
unaware that the patient was being served by another home health 
agency. A commenter expressed concern regarding the identification of 
the timing of the 30-day period, stating that the OASIS in particular 
does not provide enough information to determine timing for a 30-day 
period.
    Response: As we described in the CY 2019 HH PPS proposed rule, we 
will use Medicare claims data and not the OASIS assessment in order to 
determine if a 30-day period is considered ``early'' or ``late'' (83 FR 
32393). Regarding transfers, we note that 30-day periods are considered 
to be adjacent if they are contiguous, meaning they are separated by no 
more than a 60-day period between 30-day periods of care. This would 
mean that if a patient transfers from one HHA to another HHA after the 
first 30-day period of care, all adjacent 30-day periods of care would 
be considered ``late''. In order for any 30-day period of care to be 
considered ``early'', there would have to be a gap in home health 
services of more than 60

[[Page 56466]]

days. We have developed claims processing procedures to reduce the 
amount of administrative burden associated with the implementation of 
the PDGM. Providers will not have to determine whether a 30-day period 
is early (the first 30-day period) or later (all adjacent 30-day 
periods beyond the first 30-day period) if they choose not to. 
Information from Medicare systems will be used during claims processing 
to automatically assign the appropriate timing category. Details 
regarding these processes are outlined in the CY 2019 HH PPS proposed 
rule (83 FR 32394). We reiterate that we plan to develop materials 
regarding the timing categories, including such topics as claims 
adjustments and resolution of claims processing issues. We will also 
update guidance in the Medicare Claims Processing Manual as well as the 
Medicare Benefit Manual as appropriate with detailed procedures. We 
will also work with the MACs to address any concerns regarding the 
processing of home health claims as well as develop training materials 
to facilitate all aspects of the transition from the current payment 
system to the PDGM, including the unique aspects of the timing 
categories.
    Final Decision: We are finalizing our proposal to classify 30-day 
periods of care under the PDGM as ``early'' or ``late'' depending on 
when they occur within a sequence of 30-day periods. The first 30-day 
period would be classified as early and all subsequent 30-day periods 
in the sequence (second or later) would be classified as late and 30-
day periods of care cannot be considered early unless there is a gap of 
more than 60 days between the end of one period and the start of 
another.
5. Admission Source Categories
    In the CY 2019 HH PPS proposed rule, we described analysis showing 
the impact of the source of admission on home health resource use and 
proposed to establish two admission source categories for grouping 30-
day periods of care under the PDGM--institutional and community--as 
determined by the healthcare setting utilized in the 14 days prior to 
home health admission (83 FR 32340). We proposed that 30-day periods 
for beneficiaries with any inpatient acute care hospitalizations, 
skilled nursing facility (SNF) stays, inpatient rehabilitation facility 
(IRF) stays, or long term care hospital (LTCH) stays within the 14 days 
prior to a home health admission would be designated as institutional 
admissions. We also proposed that the institutional admission source 
category would 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 also proposed 
that we would not categorize PAC stays (SNF, IRF, LTCH stays) that 
occur during a previous 30-day period and within 14 days of a 
subsequent, contiguous 30-day period of care (that is, the admission 
date and from date for the subsequent 30-day period of care do not 
match) as institutional, as we would expect the HHA to discharge the 
patient if the patient required PAC in a different setting and then 
readmitted the patient, if necessary, after discharge from such 
setting. If the patient was discharged and then readmitted to home 
health, the admission date and ``from'' date on the 30-day claim would 
match and the claims processing system will look for an acute or a PAC 
stay within 14 days of the home health admission date. We proposed that 
this admission source designation process would be applicable to 
institutional stays both paid by Medicare or another payer. All other 
30-day periods would be designated as community admissions. For the 
purposes of a RAP, we proposed that we would only adjust the final home 
health claim submitted for source of admission. Additionally, we also 
proposed that HHAs would only indicate the proposed admission source 
occurrence codes on the final claim and not on any RAPs submitted. The 
proposed admission source category was discussed in detail in the 
proposed rule.
    We solicited public comments on the admission source component of 
the proposed PDGM. The following is a summary of the public comments 
and our responses:
    Comment: Several commenters expressed their support for the 
admission categories within the framework of the PDGM, as they believe 
patient needs significantly differ between these groups and payment 
differences are warranted in order to better reflect the cost of 
Medicare home health care, thus improving the accuracy of payments in 
the revised system.
    Response: We appreciate the commenters' support with regard to the 
admission source element of the PDGM. The intention of the PDGM 
proposal, including the admission source component, is to refine and to 
better fit costs incurred by agencies for patients with differing 
characteristics and needs under the prospective payment system, and we 
believe that the differing weights for source of admission will 
facilitate more appropriate alignment within the HH PPS.
    Comment: Several commenters stated that the source of a home health 
admission may not always correspond with home health beneficiary needs 
and corresponding provider costs, as some community entrants sometimes 
require more intensive resources than their institutional counterparts, 
presenting with complex conditions such as psychiatric and neurological 
conditions, pressure and stasis ulcers, and a history of falls. Several 
commenters also stated that we are ``devaluing'' community entrants by 
providing lower reimbursement for those beneficiaries when compared 
with institutional entrants.
    Response: As described in detail in the CY 2019 HH PPS proposed 
rule, our analytic findings demonstrate that institutional admissions 
have higher average resource use when compared with community 
admissions, which ultimately led to the inclusion of the admission 
source category within the framework of the PDGM (83 FR 32340). We do 
not seek to ``devalue'' or show preference to any particular patient 
profile, but rather aim to better align home health payment with the 
costs observed in providing care. Additionally, as discussed in our CY 
2019 HH PPS proposed rule, current research around those patients who 
are discharged from acute and PAC settings shows that these 
beneficiaries tend to be sicker upon admission, are being discharged 
rapidly back to the community, and are more likely to be re-
hospitalized after discharge due to the acute nature of their illness 
(83 FR 32396). As further described in the CY 2019 HH PPS proposed 
rule, research studies indicate that patients admitted to home health 
from institutional settings are vulnerable to adverse effects and 
injury because of the functional decline that occurs due to their 
institutional stay, indicating that the patient population referred 
from an institutional setting requires more concentrated resources and 
supports to account for and mitigate this functional decline (83 FR 
32397). We continue to believe that accounting for the material 
differences in the care needs of the home health beneficiary population 
admitted from institutional settings and their resulting, 
differentiated resource use, will serve to better align payments

[[Page 56467]]

with actual costs incurred by HHAs when providing care. We will 
carefully monitor the outcomes of this change, including any impacts to 
community entrants, and make further refinements as necessary. We also 
note that a component of the PDGM is the classification of periods of 
care into clinical groups according to the principal diagnosis 
reported. This component of the PDGM serves to capture the different 
resource needs of different conditions in the home health population, 
including complex conditions such as neurological conditions.
    Comment: Several commenters noted that the admission source 
component of the PDGM has strong explanatory power in the model, 
outweighing clinical and functional factors. Several commenters believe 
the inclusion of admission source in the PDGM is akin to the use of 
therapy thresholds in HHRGs, as the commenters assert that it has the 
potential to create inappropriate incentives. Some commenters suggested 
that admission source not be utilized used in the model; instead, only 
patient clinical and functional status should be considered. Other 
commenters believe that the payment differences by admission source is 
too great. A commenter recommended that additional analysis be 
conducted regarding the payment adjustment for admission source and 
that we determine if other elements of the case-mix system would more 
adequately account for differences in payments when compared to the 
admission source variable. Another commenter stated that the admission 
source component of the PDGM is inaccurate and will likely push 
patients into the institutional setting and suggested that we instead 
utilize a ``risk of readmission'' measure, which could serve to gauge 
patient severity and promote value-based care.
    Response: We appreciate the commenters' feedback regarding the 
admission source component of the PDGM. However, we reiterate that the 
analytic findings presented in the CY 2019 HH PPS proposed rule point 
to clear differences in resources utilized by beneficiaries with 
differing sources of admission. In developing the various elements of 
the PDGM, we sought to focus on variables that predicted care needed by 
the patient (83 FR 32340). We disagree that using an admission source 
variable is equivalent to therapy thresholds. The data supports that 
resource utilization is higher among those with beneficiaries who have 
had a previous institutional stay prior to admission to home health, 
which accounts for the explanatory power of this particular variable. 
Conversely, increased payment associated with the therapy thresholds is 
directly correlated with the number of therapy visits provided. 
Regarding the suggestion that we instead utilize a ``risk of 
readmission'' measure, we remind commenters that the PDGM does include 
an OASIS item for ``Risk for Hospitalization'' in its construction at 
the functional level to further account for patient characteristics 
that could translate into resource use. We note that we will continue 
to analyze the inclusion of other variables in the PDGM case-mix 
adjustment and will consider such additional components for future 
refinement.
    Comment: Commenters stated that inpatient settings would become the 
primary patient referral target for HHAs and that community referral 
beneficiaries may find HHAs less willing to admit them to home health 
care if CMS were to finalize the admission source categories in the 
PDGM as proposed.
    Response: We appreciate the commenters' concern regarding possible 
behavioral changes by providers given the perceived incentives created 
by the admission source categories within the PDGM. We continue to 
expect that HHAs will provide the appropriate care needed by all 
beneficiaries who are eligible for the home health benefit, including 
those beneficiaries with medically-complex conditions who are admitted 
from the community. We recognize that providers may shift practices 
based upon strategies meant to maximize payment; therefore, we plan to 
closely monitor for any concerning trends in provider behavior, 
including such metrics as proportion of cases in a provider's caseload 
referred from both the community and institutional settings. We also 
note that in previous analysis related to the solicitation of home 
health referrals, research has shown that many agencies seek referrals 
from any setting, institutional or otherwise. In the FY 2001 HH PPS 
proposed rule, evaluators assessing the HH PPS demonstration came to 
the conclusion that agencies did not alter their behavior in response 
to payment changes in the home health demonstration in such a way that 
impacted beneficiary access or quality of care, nor did they employ 
practices in order to avoid costly patients or recruit lower-care cases 
(64 FR 58140). Many agencies wanted to maintain a steady stream of 
referrals and were therefore not in a position to avoid a specific 
referral source, and, as a result, did not do so. We expect that HH 
providers will continue to seek referrals from all sources under the 
PDGM system, resulting in continued access to home health care for 
Medicare beneficiaries.
    Comment: Several commenters suggested the inclusion of inpatient 
psychiatric facility (IPF) stays in the institutional category for the 
purposes of the PDGM.
    Response: We appreciate the commenters' feedback and agree that 
inpatient psychiatric facility (IPF) stays should be included in the 
institutional category for the payment system under the PDGM. We agree 
that admission to an inpatient psychiatric facility would merit 
inclusion as an institutional source under the PDGM and therefore, we 
will include this site of service as part of the institutional category 
case-mix variable.
    Comment: Several commenters recommended that CMS consider 
incorporating other clinical settings into the definition of the 
institutional category, including hospices and outpatient facilities, 
including emergency rooms. The commenters asserted that the criteria 
for inpatient hospital admission versus outpatient and other non-acute/
PAC services are not always clear and that the differences between 
patients admitted as inpatient versus as outpatient are minimal. The 
commenters also stated that observation stays, which are not considered 
institutional stays by CMS, should be considered as such for the 
purposes of the PDGM, in part because beneficiaries and their families 
will have the ``perception'' of an inpatient stay and inform the HHA of 
what they perceive to have been an institutional stay. Another 
commenter stated that patients who utilize emergency room services 
either need a higher level of home health services once they transition 
to home health care or they require a lot of education to encourage 
them to utilize options other than the ER when issues arise. The 
commenter moreover asserted that hospitals have become adept at using 
observation stays for purposes of avoiding re-hospitalization penalties 
but maintains that these patients have just as high acuity as those 
referred to home health from a typical inpatient hospital stay. A 
commenter stated that joint replacement surgery continues to evolve, 
and patients are having surgery and are being treated as an 
``observation stay'' rather than a hospital admission despite requiring 
a high level of service once they return home. A commenter noted 
concern that categorization could limit access to home care for joint 
replacements that may occur in ambulatory surgery centers and other 
outpatient facilities,

[[Page 56468]]

settings not currently considered institutional for the purposes of the 
PDGM. Another commenter stated that the exclusion of observation stays 
and ED visits from the institutional category would create an incentive 
for HHAs to potentially encourage hospitalizations for potentially 
higher reimbursement.
    Response: We appreciate the commenters' concerns regarding 
potential impacts to those patients who may have experienced an event 
in a setting that is not defined as acute or post-acute, including 
visits to emergency departments. However, for the purposes of the PDGM, 
we will only include those stays in the institutional category that are 
considered institutional stays in other Medicare settings. As described 
in detail in the CY 2019 HH PPS proposed rule, we analyzed the resource 
use of admission source categories, including ED visits and 
observational stays, as well as corresponding payment weights based 
upon the resource use demonstrated in existing home health data (83 FR 
32340). Our findings indicate that the volume of patients utilizing 
such settings prior to a home health episode is very low. Given that 
the proportion of home health periods with admissions from ED visits 
and observational stays is low relative to community and institutional 
counterparts, we believe that creating a third community admission 
source category for observational stays and ED visits could potentially 
introduce added complexity into the payment system in order to address 
a small portion of home health stays, which could in turn lead to the 
creation of payment groups that contain very few stays with very little 
difference in case-mix weights across the landscape of groups. 
Moreover, we remain concerned that a third admission source category 
for observational stays and ED visits could potentially create an 
incentive for HHAs to encourage outpatient encounters both prior to a 
30-day period of care or within a 30-day period of care within 14 days 
of the start of the next 30-day period, thereby potentially increasing 
costs to the Medicare program overall. For all of these reasons, we 
believe that incorporating HH stays with preceding observational stays 
and ED visits into the community admission category is most appropriate 
at this time.
    While we recognize that there is more recent use of Ambulatory 
Surgery Centers (ASCs) for certain joint replacement surgeries, we do 
not have sufficient data at this time to determine the impact on home 
health resource use for beneficiaries coming from an ASC facility after 
these types of surgeries. As mentioned previously, we will only include 
those stays that are considered institutional stays in other Medicare 
settings and where ``institutional'' refers to discharges from acute-
care hospitals, IRFs, LTCHs, IPFs, and SNFs. Therefore, a discharge 
from an ASC does not meet the definition of ``institutional''. 
Likewise, discharge from hospice care would not be considered an 
institutional discharge, nor would we expect large enough numbers of 
beneficiaries discharging from hospice to home health to warrant such 
an inclusion.
    However, we note that as we receive and evaluate new data related 
to the provision of Medicare home health care under the PDGM, we will 
continue to assess the payment levels for admission source within a 
home health period and give consideration to any cost differentiation 
evidenced by the resources required by those home health patients with 
a preceding outpatient event.
    Comment: Several commenters stated that the addition of the 
admission source category and potential payment differential could 
negatively affect agencies' ability to provide the care for 
beneficiaries in the community and that the admission source categories 
placed a higher value on care provided to a beneficiary referred to 
home health care from an acute setting. Several commenters stated that 
home health community entrants are provided education and oversight as 
well as preventative and maintenance therapy and care, citing the Jimmo 
Settlement Agreement.\16\ Commenters assert that such maintenance care 
ultimately prevents beneficiaries from requiring an admission to a more 
expensive hospital setting. Several commenters stated that the 
admission source element of the PDGM would lead to reduced access to 
home-based care, which may, in turn, result in an increase in emergency 
department visits, an increase in hospital admissions, and increased 
use of high cost institutional care for patients. The commenters 
further suggested that the maintenance interventions provided produce 
value for the Medicare system and that these savings should be 
reflected through higher payment to HHAs for the care of community 
entrants.
---------------------------------------------------------------------------

    \16\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Jimmo-Settlement-Agreement.pdf.
---------------------------------------------------------------------------

    Response: HHAs should continue to provide the most appropriate care 
to Medicare home health beneficiaries, regardless of admission source 
or any other category related to home health payment in accordance with 
the home health CoP requirements at Sec.  484.60. As we noted in the CY 
2019 HH PPS proposed rule, the primary goal of home health care is to 
provide restorative care when improvement is expected, maintain 
function and health status if improvement is not expected, slow the 
rate of functional decline to avoid institutionalization in an acute or 
post-acute care setting, and/or facilitate transition to end-of-life 
care as appropriate (83 FR 32375). The primary goal of the HH PPS is to 
align payment with the costs of providing home health care. As 
described in the CY 2019 HH PPS proposed rule, we have developed the 
PDGM categories and corresponding payment weights based upon the 
resource use demonstrated in existing home health data, which shows 
that differentiated amounts are merited between the two admission 
sources (83 FR 32375). Furthermore, in our CY 2000 HH PPS final rule, 
commenters asserted that patients admitted to home health from the 
hospital were often more acutely ill and resource-intensive than other 
patients, particularly when compared with beneficiaries who had no 
institutional care prior to admission (64 FR 41147). Commenters further 
noted that home health beneficiaries referred from institutional 
settings typically required more visits and more intensive teaching. 
Given our analyses as well as clinical observations regarding the 
resource needs of the institutional entrants to home health, we believe 
that differentiated admission source categories are merited. We will 
continue to monitor home health data for impacts of this payment policy 
change, potentially evaluating for increases in hospital admissions 
during home health stays, poorer quality outcomes, and increases in 
costs for the overall Medicare program, and we will make refinements to 
the payment system as appropriate.
    Comment: Several commenters expressed concern regarding the 
operational aspects of the admission source category, requesting 
guidance for retroactive adjustments, plans for the claims readjustment 
process due to institutional claim issues, definitions for timely 
filing, and guidance regarding when occurrence codes may be utilized 
(for example, for both non-Medicare and Medicare institutional stays). 
Several commenters expressed concern that the usage of occurrence codes 
for institutional admissions will increase burden on providers, cause 
difficulties for HHAs when having to rely on institutional providers to 
submit timely claims to Medicare, and create

[[Page 56469]]

challenges when modifications to home health payments are made 
retroactively due to the re-categorization of a community stay when an 
institutional claim was not submitted correctly. Several commenters 
requested that CMS clarify the length of time that a HHA would have to 
resubmit a home health claim when it learns of a non-Medicare 
institutional stay occurring within 14 days of the home health 
admission. A commenter expressed concern regarding the usage of the 
OASIS for identification of institutional admission sources.
    Response: As described in the CY 2019 HH PPS proposed rule, we have 
developed automated claims processing procedures with the goal of 
reducing the amount of administrative burden associated with the 
admission source category of the PDGM (83 FR 32375). For example, 
Medicare systems will automatically determine whether a beneficiary has 
been discharged from an institutional setting for which Medicare paid 
the claim, using information used during claims processing to 
systematically identify admission source and address this issue. When 
the Medicare claims processing system receives a Medicare home health 
claim, the systems will check for the presence of a Medicare acute or 
PAC claim for an institutional stay. If such an institutional claim is 
found, and the institutional stay occurred within 14 days of the home 
health admission, our systems will trigger an automatic adjustment of 
the corresponding HH claim to the appropriate institutional category. 
Similarly, when the Medicare claims processing system receives a 
Medicare acute or PAC claim for an institutional stay, the systems will 
check for the presence of a subsequent HH claim with a community 
payment group. If such a HH claim is found, and the institutional stay 
occurred within 14 days of 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. The OASIS 
assessment will not be utilized in evaluating for admission source 
information.
    Moreover, we proposed that newly-created occurrence codes would 
also be established, allowing HHAs to manually indicate on Medicare 
home health claims that an institutional admission had occurred prior 
to the processing of an acute/post-acute Medicare claim, if any, by 
Medicare systems in order to receive the higher payment associated with 
the institutional admission source sooner (83 FR 35312). However, the 
usage of the occurrence codes is limited to situations in which the HHA 
has information about the acute or PAC stay. We also noted that the use 
of these occurrence codes would not be limited to home health 
beneficiaries for whom the acute/post-acute claims were paid by 
Medicare. HHAs would also use the occurrence codes for beneficiaries 
with acute/post-acute care stays paid by other payers, such as the 
Veterans Administration (VA).
    If a HHA does not include the occurrence code on the HH claim 
indicating that a home health patient had a previous institutional 
stay, processed either by Medicare or other institutions such as the 
VA, such an admission will be categorized as ``community'' and paid 
accordingly. However, if later a Medicare acute/post-acute 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 would be automatically adjusted 
and re-categorized as an institutional admission and appropriate 
payment modifications would be made. If there was a non-Medicare 
institutional stay occurring within 14 days of the home health 
admission but the HHA was not aware of such a stay, upon learning of 
such a stay, the HHA would be able to resubmit the HH claim that 
included an occurrence code, subject to the timely filing deadline, and 
payment adjustments would be made accordingly.
    Again, however, we note that the Medicare claims processing system 
will check for the presence of an acute/post-acute Medicare claim for 
an institutional stay occurring within 14 days of the home health 
admission on an ongoing basis and automatically assign the home health 
claim as ``community'' or ``institutional'' appropriately. As a result, 
with respect to a HH claim with a Medicare institutional stay occurring 
within 14 days of home health admission, we will not require the 
submission of an occurrence code in order to appropriately categorize 
the HH claim to the applicable admission source. With respect to a HH 
claim with a non-Medicare institutional stay occurring with 14 days of 
home health admission, a HHA would need to submit an occurrence code on 
the HH claim in order to have the HH claim categorized as 
``institutional'' and paid the associated higher amount.
    Additionally, we plan to provide education and training regarding 
all aspects of the admission source process and to develop materials 
for guidance on claims adjustments, for resolution of claims processing 
issues, for defining timely filing windows, and for appropriate usage 
of occurrence codes through such resources as the Medicare Learning 
Network. We will also update guidance in the Medicare Claims Processing 
Manual as well as the Medicare Benefit Policy Manual as appropriate 
with detailed procedures. We will also work with the MACs to address 
any concerns regarding the processing of home health claims as well as 
develop training materials to facilitate all aspects of the transition 
to the PDGM, including the unique aspects of the admission source 
categories.
    With regards to the length of time for resubmission of home health 
claims that reflect a non-Medicare institutional claim, all appropriate 
Medicare rules regarding timely filing of claims will still apply. 
Procedures required for the resubmission of home health claims will 
apply uniformly for those claims that require editing due to the need 
to add or remove occurrence codes. Details regarding the timely filing 
guidelines for the Medicare program are available in the Medicare 
Claims Processing Manual, Chapter 1--General Billing Requirements, 
which is available at the following website: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c01.pdf. 
Additionally, adjustments to any re-submitted home health claims will 
be processed in the same manner as other edited Medicare home health 
claims. Additionally, we plan to perform robust testing within the 
Medicare claims processing system to optimize and streamline the 
payment process.
    Comment: Another commenter requested details regarding the process 
by which HHAs should verify a non-Medicare institutional stay.
    Response: As we noted in in the CY 2019 HH PPS proposed rule, we 
expect home health agencies would utilize discharge summaries from all 
varieties of institutional providers (that is, Medicare and non-
Medicare) to inform the usage of these occurrence codes, and these 
discharge documents should already be part of the beneficiary's home 
health medical record used to support the certification of patient 
eligibility as outlined in Sec.  424.22(c) (83 FR 32340). Providers 
should utilize existing strategies and techniques for verification of 
such stays and incorporate relevant clinical information into the plan 
of care, as is already required by the Medicare CoPs.
    Comment: Several commenters expressed concern that the use of 
occurrence codes will lead to claims

[[Page 56470]]

denials by MACs and stated that MAC staff will require training in 
order to ensure appropriate application of the admission source policy 
as well as avoid any unintended consequences.
    Response: We intend to provide education and training regarding the 
usage of the admission source occurrence codes to providers through 
such tools are Medicare Learning Network articles. We are also working 
closely with the MACs to ensure proper processing of home health claims 
under the new PDGM. Additionally, as we noted in in the CY 2019 HH PPS 
proposed rule, while a home health claim with a non-Medicare 
institutional admission source can be categorized by the HHA as an 
institutional admission and paid accordingly, we may conduct medical 
review if deemed appropriate (83 FR 35312).
    Comment: Several commenters expressed concern regarding our 
proposal to potentially conduct post-payment medical review of home 
health claims in order to assess whether a home health admission was 
preceded by an institutional stay, asserting that HHAs should not be 
held responsible for other providers' claim activity. The commenters 
stated that post-payment medical review for instances in which HHAs 
manually indicate on the claim an institutional admission source, and 
the institution's claim for an acute/post-acute stay is subsequently 
denied or not filed in a timely manner could be problematic. The 
commenters stated that a denial for the acute/post-acute stay could be 
due to a number of reasons of which the HHA has no knowledge or 
involvement and noted that any denial of an institutional claim or non-
timely filing of a claim, would be outside of the control of the HHAs.
    Response: Our evaluation process within the Medicare claims 
processing system will check for the presence of an acute/post-acute 
Medicare claim for an institutional stay occurring within 14 days of 
the home health admission on an ongoing basis. Under this approach, the 
Medicare systems would only evaluate for whether an acute/post-acute 
Medicare claim for an institutional stay occurring within 14 days of 
the home health admission was processed by Medicare, not whether it was 
paid. Therefore, we do not expect that a home health claim will be 
denied due to unpaid Medicare claims for preceding acute/post-acute 
admissions. Moreover, we note that providers would have the option to 
submit the occurrence code indicating a preceding institutional stay in 
order to categorize the home health admission as ``institutional.'' If 
in the case of a Medicare institutional stay, upon review after finding 
no Medicare acute or post-acute care claims in the National Claims 
History, and there is documentation of a Medicare acute or post-acute 
care stay within the 14 days prior to the home health admission, but 
the institutional setting did not submit its claim in a timely fashion 
or at all, we would permit the institutional categorization for the 
payment of the home health claim through appropriate administrative 
action. Similarly, in the case of a non-Medicare institutional stay, if 
documentation of a non-Medicare acute or post-acute care stay within 
the 14 days prior to the home health admission, is found, we would 
permit the categorization of the home health claim as 
``institutional''. However, if upon medical review after finding no 
acute or post-acute care Medicare claims in the National Claims 
History, and there is no documentation of an acute or post-acute care 
stay, either a Medicare or non-Medicare stay, within 14 days of the 
home health admission, we would correct the overpayment and re-
categorize the stay as community. If upon medical review after finding 
no Medicare acute or post-acute care claims in the National Claims 
History and we find that an HHA is systematically including occurrence 
codes that indicate the patient's admission source was 
``institutional,'' but no documentation exists in the medical record of 
Medicare or non-Medicare stays, we would refer the HHA to the zone 
program integrity contractor (ZPIC) for further review, including any 
potential administrative action.
    Comment: A commenter suggested that we only conduct post-payment 
review for HHAs that have claims that are consistently associated with 
acute/post-acute claim denials, or whose utilization pattern of acute/
post-acute occurrence codes is aberrant when compared with their peers, 
which the commenter asserts would ensure a more equitable approach 
toward conducting post-payment medical review of home health claims.
    Response: We appreciate the commenter's suggestions regarding 
targeted approaches for medical review after the implementation of the 
admission source element of the PDGM, and we will consider such metrics 
in the development of any targeted reviews.
    Comment: Another commenter expressed concerns regarding operational 
aspects of the admission source portion of the PDGM, stating that if 
the institutional stay were billed very late in the timely filing 
period, the HHA might not receive an appropriate admission source 
adjustment within the PDGM. The commenter also expressed concern 
regarding the timely filing window for HHAs, asking if we will increase 
the timely filing period for home health agencies. The commenter also 
wanted to understand how home health agencies will know if 
institutional providers are submitting their claim correctly and 
meeting the necessary criteria. Additionally, the commenter asked why 
we were not allowing payment to the home health agency if the agency's 
billing is submitted appropriately based on the information currently 
at hand and later recalculate and adjust payment if necessary. The 
commenter also asked if discharge summaries received by home health 
from external institutions will serve as ``proof'' in the event of 
medical review. The commenter also asked what would transpire if an 
institutional provider decided post-discharge that the inpatient 
admission did not meet inpatient criteria when discharge summary 
documents still indicate the patient was being discharged to home 
health following a qualifying inpatient stay.
    Response: We appreciate the commenter's questions regarding the 
operational aspects of the admission source category within the PDGM. 
With respect to any issues around a Medicare institutional claim 
submitted near the end of the timely filing period, if the 
institutional stay is billed very late in the timely filing period, 
that institutional stay claim would trigger an automatic adjustment to 
the HH claim whenever it is received by CMS's claims processing system 
and the HHA would be paid appropriately. If there was a non-Medicare 
institutional stay occurring within 14 days of the home health 
admission but the HHA was not aware of such a stay, upon learning of 
such a stay, the HHA would be able to resubmit the HH claim that 
included an occurrence code to indicate an institutional admission 
source, subject to the timely filing deadline, and payment adjustments 
would be made accordingly. Regarding timely filing timeframes, we do 
not have the authority to extend timely filing timeframes as they are 
mandated by statute. However, the HHA may utilize the newly-established 
occurrence codes to indicate an institutional admission source without 
dependency on the claims submission by the institutional provider.
    Additionally, we reiterate that the HHA is not dependent on the 
institutional provider's ``correct'' submission of the institutional 
claim for appropriate admission source categorization, as HHAs will 
have the

[[Page 56471]]

option of including the relevant occurrence codes to indicate an HH 
admission from an institutional provider separate and apart from any 
claims submission by the institutional provider. In the case of a 
Medicare institutional stay, if the institutional setting did not 
submit its claim in a timely fashion, or at all, but there is 
documentation of a Medicare acute or PAC stay within the 14 days prior 
to the home health admission, we would permit the institutional 
categorization for the payment of the home health claim through 
appropriate administrative action. Similarly, in the case of a non-
Medicare institutional stay, if documentation of a non-Medicare acute 
or post-acute care stay within the 14 days prior to the home health 
admission, is found, we would permit the categorization of the home 
health claim as ``institutional''. Regarding the usage of discharge 
summaries as evidence of a prior institutional stay, such summaries may 
be considered in the assessment of the appropriateness of the usage of 
an occurrence code indicating admission to HH from an institutional 
setting and determinations will be made based upon the evidence 
gathered. Regarding a scenario where an institutional provider 
determines post-discharge that an admission did not meet inpatient 
criteria but the discharge summary utilized by an HHA indicated that 
the patient was being discharged to home health following a qualifying 
inpatient stay, the home health agency would not be left with a non-
covered claim. However, the home health claim may be paid as non-
institutional rather than institutional, given the source of the 
admission. Furthermore, we note that details regarding the claims 
processing instructions for Medicare home health claims will be updated 
in our Medicare Claims Processing Manual. We plan to provide education 
and training regarding all aspects of the admission source process and 
to develop materials for guidance on claims adjustments, and for 
appropriate usage of occurrence codes.
    Final Decision: We are finalizing our proposal to establish two 
admission source categories for grouping 30-day periods of care under 
the PDGM--institutional and community--as determined by the healthcare 
setting utilized in the 14 days prior to home health admission. Thirty-
day periods 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 the 14 days prior 
to a home health admission will be designated as institutional 
admissions. The institutional admission source category will also 
include patients that had an acute care hospital stay during a previous 
30-day period of care and within 14 days prior to the subsequent, 
contiguous 30-day period of care and for which the patient was not 
discharged 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 (SNF, IRF, or LTCH) or IPF stays that occur during a previous 30-
day period and within 14 days of a subsequent, contiguous 30-day period 
of care (that is, the admission date and from date for the subsequent 
30-day period of care do not match) as institutional, 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. If the patient was discharged and then readmitted to home 
health, the admission date and ``from'' date on the 30-day claim would 
match and the claims processing system will look for an acute or a 
post-acute care stay within 14 days of the home health admission date. 
This admission source designation process would be applicable to 
institutional stays paid by Medicare or another payer. All other 30-day 
periods would be designated as community admissions. For the purposes 
of a RAP, we would only adjust the final home health claim submitted 
for source of admission. For example, if a RAP for a community 
admission was submitted and paid, and then an acute or PAC Medicare 
claim was submitted for that patient before the final home health claim 
was submitted, we would not adjust the RAP and would only adjust the 
final home health claim so that it reflected an institutional 
admission. Additionally, HHAs would only indicate admission source 
occurrence codes on the final claim and not on any RAPs submitted. As 
noted previously, we plan to provide future training and guidance of 
operational aspects of claims processing under the PDGM especially 
regarding the admission source case-mix variable.
6. Clinical Groupings
    In the CY 2019 HH PPS proposed rule (83 FR 32340), we proposed 
grouping 30-day periods of care into six clinical groups: 
Musculoskeletal Rehabilitation, Neuro/Stroke Rehabilitation, Wounds-- 
Post-Op Wound Aftercare and Skin/Non-Surgical Wound Care, Behavioral 
Health Care (including Substance Use Disorder), Complex Nursing 
Interventions, and Medication Management, Teaching, and Assessment 
(MMTA). We stated that by placing periods of care into clinical groups 
reflecting the primary reason the patient is receiving home health, as 
determined by the principal diagnosis on the claim, we would capture 
the most common types of care provided and more accurately align 
payments with the cost of providing care (that is, resource use).
    In response to comments on the CY 2018 HH PPS proposed rule (82 FR 
35317) and a Technical Expert Panel (TEP) held in February 2018, we 
conducted further analysis on the division of the MMTA clinical group 
into subgroups. We conducted a thorough review of all the diagnosis 
codes grouped into the MMTA group and we grouped codes into MMTA 
subgroups based on feedback from public comments, which mainly focused 
on cardiac, oncology, infectious, and respiratory diagnoses. We created 
the additional subgroups (Surgical Aftercare, Cardiac/Circulatory, 
Endocrine, GI/GU, Infectious Diseases/Neoplasms/Blood Forming Diseases, 
Respiratory, and Other) based on data that showed above-average 
resource use for the codes in those groups, and then combined certain 
groups that had a minimal number of codes.
    Similar to the initial Home Health Groupings Model (HHGM) analysis 
conducted in 2016 that was discussed in the CY 2018 HH PPS proposed 
rule, results showed that the change in case-mix weights, as well as 
impacts to the other case-mix variables (admission source/timing, 
comorbidity adjustment) was minimal for the 30-day periods assigned to 
these subgroups compared to the case-mix weights without the subgroups. 
We showed that overall, using the MMTA subgroup model would result in 
more payment groups but no significant differences in case-mix weights 
across those groups. For that reason, in the CY 2019 HH PPS proposed 
rule, we proposed to retain the six clinical groups as shown in Table 
26, and not divide the MMTA clinical group into subgroups. A complete 
list of ICD-10-CM codes and their assigned clinical groupings is posted 
on the CMS HHA Center web page (https://

[[Page 56472]]

www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html). 
More information on the analysis and development of the groupings can 
be found in the CY 2019 HH PPS proposed rule as well as the Summary of 
the Home Health Technical Expert Panel Meeting.\17\ However, we 
solicited comments from the public on whether there may be other 
compelling reasons why the MMTA clinical group should be broken out 
into subgroups, despite analysis indicating that additional subgroups 
do not result in significant differences in case-mix weights. We noted 
that we also planned to continue to examine trends in reporting and 
resource utilization to determine if future changes to the clinical 
groupings are needed after implementation of the PDGM.
---------------------------------------------------------------------------

    \17\ https://www.cms.gov/center/provider-type/home-health-
agency-HHA-center.html.
[GRAPHIC] [TIFF OMITTED] TR13NO18.032

    The following is a summary of the public comments received on the 
proposed clinical groups under the PDGM and our responses:
    Comment: Many commenters supported the patient-centered approach to 
grouping patients by clinical characteristics, and appreciated that 
additional codes were added to the PDGM in comparison to the HHGM.
    Response: We appreciate these comments and thank the commenters for 
their support of the clinical groupings as defined in the CY 2019 HH 
PPS proposed rule.
    Comment: Many commenters reiterated concern that the MMTA group was 
too large (that is, too many 30-day periods group into the MMTA 
clinical group under the PDGM) and stated preference for more 
specificity within this group despite analysis showing a lack of 
variation in resource use across subgroups. A commenter specifically 
noted that the groupings exclude heart failure and pulmonary clinical 
groups, which are two medically complex categories that result in 
significant time and resource use in order to prevent hospital 
readmissions.
    Response: As discussed in the CY 2019 HH PPS proposed rule, health 
teaching; guidance and counseling; case management, treatments and 
procedures; and surveillance are integral in the care of the majority 
of home health patients. Additionally, these important interventions 
are often the primary reason for home health services. However, because 
these interventions cross the spectrum of diagnoses, the MMTA clinical 
group included the largest number of 30-day periods among the proposed 
clinical groups in the PDGM. Despite additional analysis showing very 
little variation in resource use after sub-dividing MMTA into smaller 
subgroups, we understand stakeholder preference to capture the 
distinctions in care provided to patients within this group. The 
majority of commenters still expressed concern with the high number of 
diagnoses that grouped into the MMTA and preferred greater specificity 
over having fewer HHRGs.
    Therefore, we will create 7 additional clinical groups to replace 
the comprehensive MMTA group. These subgroups were selected based on 
public comments in response to the CY 2018 HH PPS proposed rule and 
these comments mainly focused on cardiac, oncology, infectious disease, 
and respiratory diagnoses.\18\ We created the additional subgroups 
based on data that showed above-average resource use for codes in those 
groups, and then combined certain groups that had a minimal number of 
codes. These subgroups were presented to the TEP convened in February, 
2018 and were detailed in the CY 2019 HH PPS proposed rule; commenters 
were generally supportive of these seven subgroup designations. As 
such, these MMTA subgroups will be called:
---------------------------------------------------------------------------

    \18\ Public comments can be viewed at: Regulations.gov, ID: CMS-
2017-0100-0002: Medicare and Medicaid Programs: Home Health 
Prospective Payment System Rate Update, etc.

     MMTA--Surgical Aftercare

[[Page 56473]]

     MMTA--Cardiac/Circulatory
     MMTA--Endocrine
     MMTA--GI/GU
     MMTA--Infectious Disease/Neoplasms/Blood-forming Diseases
     MMTA--Respiratory
     MMTA--Other

    The addition of these 7 new groups generated a new table of case-
mix weights for the model. The PDGM will now contain 432 case-mix 
groups. We agree with commenters that greater specificity in the MMTA 
clinical group will help distinguish differences in care and allow for 
greater transparency in resource use. We also believe that with the 
elimination of therapy thresholds, having more discrete subgroups 
within this clinical group may result in more variation in resource use 
over time.
    Comment: Several commenters submitted specific diagnosis codes that 
they believe should be reassigned to different clinical groups or added 
to the grouper tool. Another commenter stated that any existing ICD-10-
CM diagnosis code should be considered when assigning a clinical group. 
Several commenters submitted new codes effective for October 1, 2018 
that were not in the grouper tool released with the proposed rule on 
July 2, 2018.
    Response: We thank commenters for thoroughly reviewing the PDGM 
Grouper tool and providing questions and detailed examples regarding 
the grouping of specific codes. As discussed in the CY 2019 HH PPS 
proposed rule, one of the main goals of the PDGM is to clearly account 
for resource use by highlighting the main reason for home health 
services. The ICD-10-CM code list is an exhaustive list that contains 
many codes that do not support the need for home health services and so 
are not appropriate as principal diagnosis codes for grouping home 
health periods into clinical groups. Dental codes, for example, are 
included in the ICD-10-CM code list, but are not Medicare covered 
services. Others are Medicare covered codes, but are not relevant to 
home health, for example, codes that indicate death as the outcome. 
Another reason a code is not appropriate for grouping home health 
periods into clinical groups is because of coding guidelines. For 
example, this would include codes listed out of sequence when ICD-10 
coding conventions indicate certain codes in which the underlying 
condition must be listed first (that is, Parkinson's disease must be 
listed prior to Dementia if both codes were listed on a claim).
    In addition to coding guidelines, we also looked at clinical 
practice guidelines and the interventions and skilled care involved in 
managing the diagnosis at home. We believe these guidelines provide 
valuable information for establishing a plan of care and support home 
health resource use. For instance, an infection of an amputation stump 
may only require treatment with antibiotics, whereas management of 
necrotic tissue always involves debridement and subsequent wound care 
in order to allow wound healing to take place. Thus, necrosis of an 
amputation stump clearly denotes wound care. For a period to be grouped 
into the wound category, the diagnosis on the claim must reflect a 
break in skin integrity for which clinical practice guidelines involve 
wound care necessitating skilled nursing services. A diagnosis simply 
indicating infection may or may not necessitate wound care.
    We also expect that whenever possible, the most specific code that 
describes a medical disease, condition, or injury should be documented. 
For instance many codes contain the word ``unspecified.'' Generally, 
``unspecified'' codes are used when there is lack of information about 
location or severity of medical conditions in the medical record. 
However, we would expect a provider to use a precise code whenever more 
specific codes are available. Furthermore, if additional information 
regarding the diagnosis is needed, we would expect the HHA to follow-up 
with the referring provider in order to ensure the care plan is 
sufficient in meeting the needs of the patient. We believe that a vague 
principal diagnosis does not clearly identify the primary reason for 
home health, and subsequently leads to ambiguous resource use. For 
example, T14.90 ``Injury, unspecified'', lacks clarity regarding the 
type and extent of injury and therefore, fails to indicate and support 
the needed resources. Additionally, the ICD-10-CM code set includes 
laterality. We believe a home health clinician should not report an 
``unspecified'' code if that clinician can identify the side or site of 
a condition. For example, a home health clinician should be able to 
state whether a fracture of the arm is the right or left arm.
    Similarly, many of the codes that indicate pain or contractures as 
the primary diagnosis, for example M54.5, Low back pain or M62.422, 
Contracture of muscle, right hand, although site specific, do not 
indicate the cause of the pain or contracture. We would expect a more 
definitive diagnosis indicating the cause of the pain or contracture, 
as the reason for the skilled care, in order to appropriately group the 
home health period.
    We also believe that the majority of the R codes (codes that 
describe signs and symptoms, as opposed to diagnoses) are not 
appropriate as principal diagnosis codes for grouping home health 
periods into clinical groups. While we recognize that the coding 
guidelines allow for the reporting of signs, symptoms, and less well-
defined conditions, HHAs are required to establish an individualized 
plan of care in accordance with the home health CoPs at Sec.  484.60. 
The plan of care must specify the services necessary to meet the 
patient-specific needs as identified during the comprehensive 
assessment. This includes identification of the responsible 
discipline(s), and anticipated measurable outcomes as a result of 
implementing and coordinating the plan of care. We believe that the use 
of symptoms, signs, and abnormal clinical and laboratory findings would 
make it difficult to meet the requirements of an individualized plan of 
care. Likewise, we believe that clinically it is important for home 
health clinicians to have a clearer understanding of the patients' 
diagnoses in order to safely and effectively furnish home health 
services. Interventions and treatment aimed at mitigating signs and 
symptoms of a condition may vary depending on the cause. For example, 
if a patient has been referred to home health with a diagnosis of 
``other abnormalities of gait and mobility'' (R26.89), we believe it is 
important for the home health clinician to know what is precipitating 
the abnormality. For instance, a plan of care for a gait abnormality 
related to a neurological diagnosis is likely to be different from a 
plan of care for a gait abnormality due to a fracture or injury. 
Anecdotally, we have heard that the home health referral may be non-
specific or that the physician may be in the process of determining a 
more definitive diagnosis. However, with respect to patient safety and 
quality of care, we believe it is important for a clinician to 
investigate the cause of the signs and/or symptoms for which the 
referral was made. This may involve calling the referring physician to 
gather more information regarding the gait abnormality. We note that 
HHAs are required under the home health CoPs at Sec.  484.60 to 
participate in care coordination to assure the identification of 
patient needs and factors that could affect patient safety and 
treatment efficacy. Coding guidelines are clear that R codes are to be 
used when no more specific diagnosis can be made even after all the 
facts bearing on the case have been investigated. Therefore, these 
codes

[[Page 56474]]

should not be used as a primary diagnosis for the provision of home 
health services while a physician may still be in the diagnostic 
process. By the time the patient is referred to home health and meets 
the qualifications of eligibility, we would expect that a more 
definitive code exists to substantiate the need for services. 
Furthermore, commenters have indicated a preference for greater 
specificity in the clinical groups, therefore, we believe this should 
extend to the codes within the clinical groups as well.
    Another commonly reported diagnosis, M62.81, ``Muscle weakness, 
generalized'' is extremely vague. Generalized muscle weakness, while 
obviously a common condition among recently hospitalized patients does 
not clearly support a rationale for skilled services and does not lend 
itself to a comprehensive plan of care. In Sec.  409.44(c)(1)(ii) we 
state that ``the patient's clinical record must include documentation 
describing how the course of therapy treatment for the patient's 
illness or injury is in accordance with accepted professional standards 
of clinical practice.'' If there is not an identified cause of muscle 
weakness, then it would be questionable as to whether the course of 
therapy treatment would be in accordance with accepted professional 
standards of clinical practice. Additionally, in the 2008 HH PPS final 
rule, we identified ``muscle weakness (generalized)'' as a nonspecific 
condition that represents general symptomatic complaints in the elderly 
population. We stated that inclusion of this code ``would threaten to 
move the case-mix model away from a foundation of reliable and 
meaningful diagnosis codes that are appropriate for home care'' (72 FR 
49774). Specifically, the 2008 HH PPS final rule stipulated that the 
case-mix system avoid, to the fullest extent possible, non-specific or 
ambiguous ICD-9-CM codes, codes that represent general symptomatic 
complaints in the elderly population, and codes that lack consensus for 
clear diagnostic criteria within the medical community. We believe that 
diagnostic approaches to determining the cause of muscle weakness, 
polyneuropathy, and other vague conditions, combined with the expanded 
ICD-10 list, ensure that codes exist that more clearly describe a 
patient's need for home health. With respect to commenter rationale for 
coding ``Muscle weakness, generalized'' in response to severe 
deconditioning and weakness due to extended hospitalization, we believe 
a more appropriate code would be one of the muscle wasting and atrophy 
codes as grouped into the musculoskeletal group. Muscle wasting and 
atrophy would indicate the reason for the generalized muscle weakness 
and provide more clarity for the necessity of skilled services.
    Using these guidelines, we worked with certified coders to review 
all of the codes submitted with commenter feedback. We included the new 
codes added with respect to Fiscal Year 2018 (for use beginning October 
1, 2017) and with respect to Fiscal Year 2019 (for use beginning 
October 1, 2018) and grouped the MMTA diagnosis codes into the 
appropriate sub-groups. We remind commenters that the ICD 10-CM code 
list is updated each fiscal year with an effective date of October 1st. 
Because of an annual October effective date for updated ICD 10-CM 
codes, the HH PPS is subject to two Grouper releases, one in October 
and one in January, to ensure that claims are submitted with the most 
current code set available. Additionally, we re-grouped many of the 
codes submitted by commenters based on feedback we received and changed 
the clinical grouping of many additional codes based on commenter 
rationale. For example, we agree with commenters regarding many of the 
S and T codes where the fracture and/or injury is unspecified, but the 
site is specified. We maintain that the site of injury and/or fracture 
should be identified; however, we believe that, as the treatment or 
intervention would likely not change based on the exact type of injury 
or fracture, many of these codes are appropriate to group the period 
into a clinical group. These codes were changed to either the 
musculoskeletal group or the wounds group. We also agreed with 
commenters regarding some of the combination diagnosis/symptom codes. 
For example, we re-grouped I13.2, Hypertensive heart and chronic kidney 
disease with heart failure and with stage 5 chronic kidney disease, or 
end stage renal disease into MMTA- Cardiac/Circulatory, as despite the 
likelihood that the patient is covered under the End Stage Renal 
Disease (ESRD) benefit, the patient may also be receiving home health 
services for hypertension. We also agree that Z46.6, Encounter for 
fitting and adjustment of urinary device should be grouped into the 
Complex Nursing Interventions group.
    Regarding A41.0, Sepsis due to Staphylococcus aureus and A40.0, 
Sepsis due to streptococcus, group A, as guidelines state that a sepsis 
diagnosis should be assigned the appropriate code for the underlying 
systemic infection, these codes will be classified under MMTA--
Infectious Disease/Neoplasms/Blood-forming Diseases. With regards to 
Z45.2, Encounter for adjustment and management of VAD, per coding 
guidelines, Z45.2 can be reported as the principal diagnosis and will 
remain in the Complex Nursing Interventions group. However, we 
recognize that coding guidelines indicate that if treatment is directed 
at current, acute disease, then the disease diagnosis code should be 
reported first, followed by the Z aftercare codes. Therefore, in a case 
where the patient is receiving an IV antibiotic for sepsis, as the HHA 
is required to code sepsis as the primary diagnosis, the Z code must be 
listed as the first secondary diagnosis code listed on the claim in 
order to group the period into the Complex Nursing Interventions group.
    Ultimately we believe that precise coding allows for more 
meaningful analysis of home health resource use and ensures that 
patients are receiving appropriate home health services as identified 
on an individualized plan of care. We thank the commenters for their 
in-depth review and suggested changes to the ICD-10-CM code assignments 
for the clinical groups under the PDGM. We note that we did regroup 
additional codes to the ones identified in this section, based on the 
reasons previously discussed, and we encourage HHAs to continue to 
review the list of diagnosis codes in the PDGM Grouper Tool posted with 
the final rule on the HHA Center web page (https://www.cms.gov/center/
provider-Type/home-Health-Agency-HHA-Center.html). Commenters are 
encouraged to continue to submit comments to the home health policy 
mailbox ([email protected]) regarding diagnosis coding under 
the PDGM. We will continue to review ICD-10-CM code assignments for the 
clinical groups under the PDGM and make future refinements as 
necessary, including refinements to reflect new codes added to the ICD 
10-CM code list.
    Comment: Another commenter expressed concern about patients grouped 
into the MMTA group who experience a change of condition that warrants 
additional resources during a period of care that is not properly 
accounted for under the PDGM. The commenter gave the example of an MMTA 
patient who experiences a fall and thereafter requires therapy services 
which are not accounted for in the case-mix weight based on the HHRG. 
The commenter suggested that ``it may be necessary for CMS to reinstate 
a payment adjustment similar to the Significant Change in Condition 
(``SCIC'') adjustment when HHGM is

[[Page 56475]]

implemented to address these patients' needs.''
    Response: If the primary diagnosis changes between the first and 
the second 30-day periods, then the claim for the second 30-day period 
would reflect the new diagnosis, and providers would not change the 
claim for the first 30-day period. We note that if a patient 
experienced a significant change in condition before the start of a 
subsequent, contiguous 30-day period, for example due to a fall, in 
accordance with Sec.  484.55(d)(1)(ii), the HHA is required to update 
the comprehensive assessment. Furthermore, in accordance with Sec.  
484.18(b) the total plan of care is reviewed by the attending physician 
and HHA personnel as often as the severity of the patient's condition 
requires, but at least once every 60 days or more frequently when there 
is a beneficiary elected transfer; a significant change in condition 
resulting in a change in the case-mix assignment; or a discharge and 
return to the same HHA during the 60-day episode. A follow-up 
assessment would be submitted at the start of the second 30-day period 
to reflect the change in the functional level and the second 30-day 
claim would be grouped into its appropriate case-mix group accordingly. 
In this respect, two 30-day periods can have two different case-mix 
groups to reflect any changes in patient condition. This is different 
from the current payment system where the case-mix group does not 
change in the middle of a 60-day episode. However, similar to the 
current system, the case mix group cannot be adjusted within each 30-
day period. 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 a claims adjustment if the assessment is 
received after the claim has been submitted, if the assessment items 
would change the payment grouping.
    Comment: A few commenters questioned what will happen when a 
provider who has a claim returned for a principal diagnosis code that 
does not group into one of the six clinical groups and the provider 
corrects the claim by changing the principal diagnosis to one that 
corresponds to a clinical category. The commenter expressed concern 
that this may be regarded as ``up-coding'' and wanted to know how CMS 
would prevent this.
    Response: As we are posting a complete list of ICD-10-CM codes that 
are available at the time of this final rule with comment period and 
their assigned clinical groupings on the CMS HHA Center web page, HHAs 
should have ample time to become familiar with codes that would be used 
to group 30-day periods of care into the 12 clinical groupings, 
therefore we believe the number of returned claims should be minimal as 
HHAs will avoid listing codes as the principal diagnosis code on the 
home health claim knowing in advance that such claims will be returned 
to the provider for more appropriate or specific coding. Returning a 
claim for more appropriate or specific coding would not be considered 
as ``up-coding'' assuming the documentation clearly supports the need 
for services. Furthermore, it is required per Sec.  409.43(c)(4) that 
any changes in the plan of care must be signed and dated by a 
physician. If a claim is returned for more specific coding, then it is 
expected that the diagnosis on the plan of care will be corrected as 
well.
    Under the PDGM, case-mix assignment is based, in part, on certain 
items in patient assessments completed by home health agencies and the 
diagnoses reported on the home health claim. Thus, if the average case-
mix weight of Medicare home health patients increases over time, the 
extent to which case-mix increases reflect real changes in patient 
characteristics versus nominal case-mix changes attributable to changes 
in coding practices (more commonly referred to as ``up-coding'') has 
been examined. CMS examines the proportion of total case-mix change 
that is nominal versus real across all HHAs on an annual basis as this 
has important implications for determining home health payment rates 
that are accurate and reasonable. We do not determine nominal case-mix 
changes on a case-by-case basis.
    Comment: A commenter indicated that SNFs and HHAs should use the 
same diagnosis classification system. Another commenter noted that 
providers do not generally determine their treatment based on a 
patient's clinical diagnosis, but rather ``treat the body structure and 
impairments derived from the diagnosis within each patient's unique 
environment.'' This commenter also suggested building a ``Diagnosis-
Driven Groupings Model.''
    Response: We stated in the CY 2019 HH PPS proposed rule that we 
agree that diagnosis alone does not provide the entire clinical picture 
of the home health patient. However, we maintain that a diagnosis is 
important to the overall care of a patient, as it crosses disciplines 
when identifying signs and symptoms of a disease or condition that may 
impact care planning. We stated that we believe that different 
healthcare disciplines use the signs and symptoms associated with a 
diagnosis to apply their own approach and skill set to treat the 
patient. We also reiterated that the clinical group is only one aspect 
of the PDGM, and that the combination of the clinical group with the 
other aspects of the PDGM, such as functional level and comorbidity 
adjustment, provide a more complete picture of the patient, allowing a 
thorough understanding of the resources needed for treatment. Payment 
would, in turn, be aligned with the more clearly defined resource use. 
It is unclear why the commenter suggested a ``Diagnosis-Driven 
Groupings Model,'' as the preceding comment indicates a rejection of 
the concept of grouping patients by diagnosis, but rather favors 
grouping patients by impairment. We would argue that, as the clinical 
group is determined by the patient's primary diagnosis, this aspect of 
the PDGM is diagnosis-driven. While CMS is making strides in aligning 
the patient assessment instruments, and in some cases aligning the 
case-mix adjustment methodology by virtue of removing therapy visit/
minute thresholds, across the four post-acute care settings; we note 
that the SNF and HH benefits do not include the same set of services. 
For example, while not covered under the Medicare home health benefit, 
SNF covered services include room and board, medications, and ambulance 
transportation. Based on differences in setting of care and coverage 
between the SNF and Home Health benefits, we believe that there are 
appropriate reasons for the case-mix adjustment methodology to differ 
between the two settings.
    Comment: Some commenters stated that patients who are not 
categorized into either the musculoskeletal or neuro rehabilitation 
groups, but who require physical therapy, occupational therapy, or 
speech-language pathology services may be at risk for receiving an 
inordinately low level of rehabilitation due to the allocation of 
resources to address those patients' other conditions. Another 
commenter indicated this undermined Jimmo Settlement Agreement and the 
provision of maintenance therapy. A commenter suggested removing 
therapy thresholds in stages. Another commenter also requested that CMS 
institute a mechanism within the PDGM to hold providers accountable for 
the delivery of appropriate, medically necessary care and provide 
safeguards to ensure how the delivery of therapy services aligns with 
individual patient characteristics and clinical needs.
    Response: With respect to the provision of therapy services as they

[[Page 56476]]

relate to the home health period's clinical group, we should emphasize 
that although the principal diagnosis is a contributing factor in the 
PDGM and determines the clinical group, it is not the only 
consideration in determining what home health services are needed in a 
patient's care plan. We stated in the CY 2019 HH PPS proposed rule that 
it is the responsibility of the patient's treating physician to 
determine if and what type of therapy (that is, maintenance or 
otherwise) the patient needs regardless of clinical grouping. As such, 
we continue to expect the ordering physician in conjunction with the 
therapist to develop and follow a plan of care for any home health 
patient, regardless of clinical group, as outlined in the skilled 
service requirements when therapy is deemed reasonable and necessary. 
Therefore, a home health period's clinical group should not solely 
determine the type and extent of therapy needed for a particular 
patient.
    Ultimately, case-mix adjustment takes into account the resource use 
of different groups of home health patients, and although not the sole 
determinant, diagnosis has always been a factor. Highlighting the 
principal diagnosis in the case-mix model helps to define the primary 
reason for home health, but does not in any way dictate what services 
should be included in the plan of care. Therefore, if the primary 
reason for home health care is for maintenance purposes with the 
primary need being therapy, this would be indicated on the plan of care 
and the patient would likely be grouped into one of the therapy groups.
    The home health benefit is a bundled payment. It allows home health 
agencies the discretion to allocate resources based on their knowledge 
of the patient and the services needed to meet the goals of the 
individualized home health plan of care. This would mean that the HHA 
would consider the most appropriate and efficient use of home health 
services based on patient needs. Therefore, therapy may be an important 
service in any of the clinical groups; however, it may not necessarily 
be the primary reason for home health care, which is what the clinical 
group is intended to capture. Similarly, we expect that skilled 
nursing, home health aide, and medical social services would likely be 
included in the care plan for patients in the rehabilitation clinical 
groups.
    While implementing the use of safeguards to ensure comprehensive 
evaluation of therapy needs is out of scope for this rule, we note that 
the home health CoPs establish the health and safety standards for care 
given to Medicare home health beneficiaries. As such, the CoPs would 
include such safeguards such as the type and frequency of patient 
assessments. Finally, section 1895(b)(4)(B)(ii) of the Act, as added by 
section 51001 of the BBA of 2018 requires elimination of therapy 
thresholds as part of the case-mix adjustment methodology, effective 
for January 1, 2020.
    Comment: Another commenter expressed concern with the lower 
reimbursement assigned to the musculoskeletal rehabilitation clinical 
group, stating that home health providers may not have the same 
incentives to admit and treat these patients under PDGM. Another 
commenter suggested the addition of a complex therapy clinical group.
    Response: We believe that it is important to look at the entire 
structure of the model, not only the clinical grouping, in order to 
understand how a patient with different skilled therapy or nursing 
needs are placed into a payment group. The clinical grouping is only 
one step in establishing a home health payment for a period of care. 
Again, this group is based on the principal diagnosis listed on the 
claim as well as specific OASIS items that indicate the need for more 
complex interventions that correlate with higher resource use. The 
clinical group is intended to capture the main reason the patient is 
receiving home health, but as we state in the CY 2019 HH PPS proposed 
rule, we understand that not all care needs can be identified by a 
diagnosis alone. Therefore, after the primary reason for the 30-day 
period is captured by the clinical grouping, the PDGM then takes into 
account the functional impairment level of the patient. Decreasing 
functional status, as indicated by a specific set of OASIS items, is 
associated with increased resource use. We believe that the functional 
impairment level of patients, when combined with the clinical grouping, 
would capture additional resource use from any multi-disciplinary 
therapy patients, or patients with ``complex-therapy'' needs. For 
instance, a patient grouped into the Neuro-Rehabilitation clinical 
grouping with a high Functional Impairment Level indicates increased 
therapy needs, potentially utilizing all skilled therapy disciplines. 
Additionally, the comorbidity adjustment further case mixes the period 
and increases payment to capture the additional resource use for a 
patient regardless of whether the services are skilled nursing or 
therapy based. Therefore, a patient with complex needs, including 
multiple therapy services and medical management, is captured by the 
combination of the different levels of the model. Furthermore, we note 
that the current payment model does not differentiate between 
utilization of therapy disciplines and whether or not all three therapy 
disciplines are utilized for the same patient. We believe that the 
PDGM's functional impairment level when combined with the clinical 
grouping provides a much clearer picture of the patient's needs, 
particularly in relation to therapy services.
    Final Decision: We are finalizing, with modification, our approach 
to grouping 30-day periods of care into clinical groups that represent 
the primary reason for home health care. We are finalizing twelve 
clinical groups, as shown in Table 27, which capture the most common 
primary reasons for home health care. The additional groups are a 
result of dividing the MMTA clinical group into 7 sub-groups. We note 
that although we are categorizing patients into twelve groups according 
to the principal diagnosis, these groups do not reflect all the care 
being provided to the home health patient during a 30-day period of 
care. Home health care remains a multidisciplinary benefit. 
Additionally, as stated in the CY 2019 HH PPS proposed rule, we will 
continue to examine trends in reporting and resource utilization to 
determine if future changes to the clinical groupings are needed after 
implementation of the PDGM in CY 2020.

[[Page 56477]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.033

7. Functional Impairment Levels and Corresponding OASIS Items
    As part of the overall case-mix adjustment under the PDGM, we 
proposed in the CY 2019 HH PPS proposed rule to include a functional 
impairment adjustment to account for the resource costs associated with 
providing home health care to those patients with functional 
impairments. Research has shown a relationship exists between 
functional status, rates of hospital readmission, and the overall costs 
of health care services.\19\ Functional status is defined in a number 
of ways, but generally, functional status reflects an individual's 
ability to carry out activities of daily living (ADLs) and to 
participate in various life situations and in society.\20\ CMS 
currently requires the collection of data on functional status in home 
health through a standardized assessment instrument: the Outcome and 
Assessment Information Set (OASIS).
---------------------------------------------------------------------------

    \19\ Burke, R. MD, MS, Whitfield, E. Ph.D., Hittle, D. Ph.D., 
Min, S. Ph.D., Levy,C. MD, Ph.D., Prochazka, A. MD, MS, Coleman, E. 
MD, MPH, Schwartz, R.MD, Ginde, A. (2016). ``Hospital Readmission 
From Post-Acute Care Facilities: Risk Factors, Timing, and 
Outcomes''. The Journal of Post-Acute Care and Long Term Care 
Medicine. (17), 249-255.
    \20\ Clauser, S. Ph.D., and Arlene S. Bierman, M.D., M.S. 
(2003). ``Significance of Functional Status Data for Payment and 
Quality''. Health Care Financing Review. 24(3), 1-12.
---------------------------------------------------------------------------

    Including functional status in the case-mix adjustment methodology 
allows for higher payment for those patients with higher service needs. 
As functional status is commonly used for risk adjustment in various 
payment systems, including in the current HH PPS, we proposed that the 
PDGM would also adjust payments based on responses to selected 
functional OASIS items that have demonstrated higher resource use. 
Generally, worsening functional status is associated with higher 
resource use, indicating that the responses to functional OASIS items 
may be useful as adjustors to construct case-mix weights for an 
alternative case-mix adjustment methodology.
    Each proposed OASIS item included in the PDGM has a positive 
relationship with resource use, meaning as functional status declines 
(as measured by a higher response category), home health periods have 
more resource use, on average. In the CY 2019 HH PPS proposed rule, we 
proposed that the following OASIS items would be included as part of 
the functional impairment level adjustment under the PDGM:
     M1800: Grooming.
     M1810: Current Ability to Dress Upper Body.
     M1820: Current Ability to Dress Lower Body.
     M1830: Bathing.
     M1840: Toilet Transferring.
     M1850: Transferring.
     M1860: Ambulation/Locomotion.
     M1033 Risk of Hospitalization (at least four responses 
checked, excluding responses #8, #9, and #10).\21\
---------------------------------------------------------------------------

    \21\ Exclusions of the OASIS C-1 Item M1033 include, response 
#8: ``currently reports exhaustion''; response #9: ``other risk(s) 
not listed in 1-8; response #10: None of the above.

Due to the lack of variation in resource use across certain responses 
and because certain responses were infrequently chosen, we combined 
some responses into larger response categories to better capture the 
relationship between worsening functional status and resource use. The 
resulting combinations of responses for the OASIS items previously 
discussed are found at Exhibit 7-2 in the technical report, ``Overview 
of the Home Health Groupings Model,'' on the HHA Center web page.\22\
---------------------------------------------------------------------------

    \22\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------

    Under the PDGM, a home health period of care receives points based 
on each of the responses associated with

[[Page 56478]]

the proposed functional OASIS items which are then converted into a 
table of points corresponding to increased resource use. That is, the 
higher the points, the higher the functional impairment. The sum of all 
of these points' results in a functional impairment score which is used 
to group home health periods into a functional level with similar 
resource use. We proposed three functional impairment levels of low, 
medium, and high with approximately one-third of home health periods 
from each of the clinical groups within each level. This means home 
health periods in the low impairment level have responses for the 
proposed functional OASIS items that are associated with the lowest 
resource use on average. Home health periods in the high impairment 
level have responses for the proposed functional OASIS items that are 
associated with the highest resource use on average. We also proposed 
that the functional impairment level thresholds would vary between the 
clinical groups to account for the patient characteristics within each 
clinical group associated with increased resource costs affected by 
functional impairment. In the CY 2019 HH PPS proposed rule, we also 
discussed the potential, future inclusion of the IMPACT Act section GG 
functional items, which will be collected on the OASIS starting January 
1, 2019. A detailed analysis of the development of the functional 
points and the functional impairment level thresholds by clinical group 
can be found in the technical report on the HHA Center web page.
    As noted in section III.F.6 of this final rule with comment period, 
we are subdividing the MMTA clinical group into seven sub-groups (MMTA-
aftercare; cardiac/circulatory; endocrine; gastrointestinal/
genitourinary; infectious disease/neoplasms/blood-forming diseases; 
respiratory; and other) to more accurately capture unique patient 
characteristics associated with patients receiving home health services 
for medication management, teaching, and assessment. As such, we 
recalculated the functional points and the thresholds for the 
functional impairment levels by clinical group. This also resulted in a 
few minor changes to the functional thresholds compared to the 
thresholds in the CY 2019 HH PPS proposed rule (Table 42, 83 FR 32406). 
The updated OASIS points table for the functional items and the table 
of functional impairment level thresholds for by clinical group are 
found in Tables 28 and 29.
[GRAPHIC] [TIFF OMITTED] TR13NO18.034


[[Page 56479]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.035

    In the CY 2019 HH PPS proposed rule, we solicited comments on the 
proposed functional OASIS items, the associated points, and the 
thresholds by clinical group used to group patients into three 
functional impairment levels under the PDGM, as previously outlined. 
The majority of comments received were very similar to those received 
on the alternate case-mix adjustment methodology (HHGM), in the CY 2018 
HH PPS proposed rule. The comments received are summarized in this 
section.
    Comment: Most commenters agreed that the level of functional 
impairment should be included as part of the overall case-mix 
adjustment in a revised case-mix model. Commenters stated that 
including a robust functional level variable in the home health payment 
system will eliminate the incentive to provide unnecessary therapy 
services to reach higher classifications for payment but will also move 
the HH PPS toward greater consistency with other post-acute care PPS.
    Response: We thank commenters for their careful review of all 
variables contributing to the overall case-mix adjustment in the PDGM. 
We agree that functional status is an important component in 
understanding patient characteristics to help facilitate the 
development of an individualized home health plan of care based on 
identified needs and to help ensure that payment

[[Page 56480]]

is in alignment with the costs of providing care.
    Comment: Several commenters supported the examination and possible 
inclusion of the IMPACT Act's section GG, Functional Abilities and 
Goals, as part of the functional level case-mix adjustment in the PDGM. 
A commenter remarked that by adding the section GG functional items to 
the HH VBP model and the HH QRP, CMS would be able to better monitor 
provider behavior to detect inappropriate responses to implementation 
of the PDGM, including withholding therapy services that could result 
in poor outcomes; selecting patients who are likely to be relatively 
more profitable; generating unnecessary periods of care; or prematurely 
discharging patients. However, a few commenters recommended that CMS 
study and validate the predictive capability of such items prior to 
pursuing any refinements to the PDGM's functional level category. This 
commenter remarked that it is critical that CMS is confident in the 
capability of Section GG functional items to sufficiently predict 
functional impairment level and associated resource use.
    Response: We appreciate the commenter feedback on the potential use 
of the GG functional items as part of the functional impairment level 
case-mix adjustment in the PDGM. We remind commenters that because 
these GG functional items are not required to be collected on the OASIS 
until January 1, 2019, we do not have the data at this time to 
determine the effect, if any, of these newly added items on resource 
costs during a home health period of care. Therefore, the GG functional 
items would not be used immediately upon implementation of the PDGM in 
CY 2020. We will continue to analyze all OASIS items, including the 
newly added GG functional items, after the implementation of the PDGM, 
to determine if the data supports any refinements to the case-mix 
adjustments. The goal is to keep only those items that are reliable, 
validated, have an impact on resource utilization, and address quality 
outcomes in order to ultimately decrease the number of OASIS items and 
reduce burden. Likewise, while the GG functional items may be able to 
play an important role in the HHVBP Model and HH QRP in monitoring for 
quality outcomes, their consideration for use in the PDGM would be to 
identify their relationship to resource utilization to more accurately 
align payment with home health costs.
    Comment: Commenters stated that the functional impairment level 
thresholds do not fully capture the functional impairments that 
translate to the actual resources needed on the home health plan of 
care. Many commenters believe that the functional impairment level 
adjustment is relatively small and inadequate to reimburse for patients 
with chronic care needs potentially creating access issues for people 
who are chronically ill and may require a prolonged period of home 
health care. Many commenters remarked that HHAs would not admit these 
types of patients or would cut back on the number of therapy visits 
provided, especially now that therapy thresholds will be removed in CY 
2020. Several commenters stated that the PDGM favors only patients who 
are expected to improve and not those who require ongoing, maintenance 
therapy but do not group into one of the predominantly therapy groups 
and therefore is counter to the provisions in the Jimmo Settlement 
Agreement.
    Response: We believe that the functional impairment level 
adjustment would adequately capture the level of functional impairment 
based on patient characteristics reported on the OASIS. The PDGM not 
only uses the same five OASIS items used in the current HH PPS to 
determine the functional case-mix adjustment (M1810, M1820, M1830, 
M1830, M1850, and M1860), but adds two additional OASIS items (M1800 
and M1033) to determine the level of functional impairment. The 
structure of categorizing functional impairment into Low, Medium, and 
High levels has been part of the home health payment structure since 
the implementation of the HH PPS. The current HH PPS groups home health 
episodes using functional scores based on functional OASIS items with 
similar average resource use within the same functional level, with 
approximately a third of episodes classified as low functional score, a 
third of episodes are classified as medium functional score, and a 
third of episodes are classified as high functional score. Likewise, 
the PDGM groups' home health periods of care using functional 
impairment scores based on functional OASIS items with similar resource 
use and has three levels of functional severity: low, medium and high. 
However, the PDGM differs from the current HH PPS functional variable 
in that the three functional impairment level thresholds in the PDGM 
vary between the clinical groups. The PDGM functional impairment level 
structure accounts for the patient characteristics within that clinical 
group associated with increased resource costs affected by functional 
impairment. This is to further ensure that payment is more accurately 
aligned with actual patient characteristics and resource needs. As 
such, we believe the more granular structure of these functional levels 
provides the information needed on functional impairment and allows 
greater flexibility for therapists to tailor a more patient-centered 
home health plan of care to meet the individualized needs of their 
patients.
    We disagree that the functional impairment level case-mix payment 
adjustment is inadequate and that the PDGM would inhibit access to care 
for those with patients with complex and/or chronic care needs and high 
functional impairments. The absence of discipline-related therapy 
thresholds allows for a more equitable distribution of services based 
on patient needs, including needs for chronically ill patients. We note 
that the PDGM is structured to capture patient characteristics, 
including functional impairment status, similar to the functional case-
mix adjustment in the current HH PPS. As HHA-reported OASIS information 
determines the payment amounts for each of the functional levels, 
accurate reporting on the OASIS by HHAs will help to ensure that the 
case-mix adjustment is in alignment with the actual level of functional 
impairment.
    We also disagree with the comment that the PDGM favors only those 
home health patients who are expected to improve, does not take into 
account patients with longer term maintenance therapy needs, and is 
counter to the provisions of the Jimmo Settlement Agreement. We remind 
commenters that the structure of the home health benefit requires a 
multidisciplinary approach, and the PDGM promotes the provision of not 
only therapy services, but skilled nursing, home health aide, and 
medical social services as well. The clinical groups, as well as the 
functional impairment level case-mix adjustment, account for the full 
range of services available under the Medicare home health benefit. We 
believe that the functional impairment level adjustment compensates for 
the resource needs of those with functional impairment and ongoing 
therapy needs, and therefore does not endorse one type of patient over 
another. There has never been an expectation that only patients who 
demonstrate the ability to improve are eligible for the Medicare home 
health benefit. We have educated the MACs extensively to ensure that 
any medical review of claims for cognitively or functionally impaired 
patients who are receiving maintenance therapy to prevent further 
deterioration, are doing

[[Page 56481]]

so according to the parameters within the Jimmo Settlement Agreement.
    We believe adding a more robust and granular functional impairment 
level adjustment should preserve, and potentially increase access to 
therapy services for vulnerable patients who may not otherwise have 
received needed therapy services, including those with complex and/or 
chronic care needs. As such, we would expect continued admissions of 
these patient populations with therapy visits provided in accordance 
with physician orders as documented on the plan of care, including the 
frequency and duration of these orders. We remind HHAs that the PDGM 
case-mix adjusters work in tandem to reflect a patient's resource 
needs. The overall payment for a home health period of care under the 
PDGM is determined by the cumulative effect of all of the variables 
used in the case-mix adjustments. Ultimately, the goal of the PDGM is 
to provide more accurate payment based on the identified resource use 
of different patient groups.
    The PDGM is not limiting or prohibiting the provision of therapy 
services or the number of home health periods of care, nor is there a 
reduction to the overall base rate of home health payment. The 
commenters imply that HHAs would ``cherry pick'' the type of patients 
to admit primarily based on Medicare payment under the PDGM and that 
care decisions, including the number of therapy visits, are determined 
solely on profitability of patients. As such, any potential access 
issues would be the result of a change in HHA behavior in response to 
the removal of therapy thresholds to maximize margins of a bundled 
payment rather than the result of a case-mix adjustment model that 
seeks to more accurately pay for home health services. Manipulating 
visit patterns, including the type and number of visits provided, and/
or admitting only certain patient populations to maximize payment is 
counter to the purpose of a prospective payment system and the intent 
of a patient-driven Medicare home health benefit. Furthermore, this 
could result in a violation of the home health CoPs and may signal 
program integrity issues. We will continue to monitor the impact of all 
of the case-mix adjustments in the PDGM to determine if any changes to 
utilization are occurring, especially as they relate to the provision 
of therapy. This may involve, but is not limited to, comparative 
analysis of utilization patterns prior to and after the implementation 
of the PDGM and could result in additional enforcement actions as a 
result of any program integrity concerns. Likewise, the BBA of 2018 
requires that we calculate the 30-day budget-neutral payment amount 
based on assumed behavior changes resulting from the implementation of 
a 30-day unit of payment and the PDGM. The law also requires that we 
annually analyze the impact of differences between the assumed and 
actual behavioral changes on estimated aggregate expenditures for CYs 
2020 through 2026 and to make any payment amount adjustments, either 
upwards or downwards, accordingly.
    Comment: Some commenters remarked that the PDGM diminishes and 
devalues the role physical, occupational, and speech language pathology 
therapists play in quality outcomes by alleviating risks of increased 
falls, emergency room visits, re-hospitalizations, improving or 
maintaining functional level, and keeping patients in their homes. 
Other commenters stated that minimization of the importance of the home 
health therapy disciplines would cause therapists to lose their jobs in 
home health. Commenters said that access to home therapy will be 
significantly curtailed as a result and functional outcomes would be 
negatively impacted. These commenters remarked that the PDGM appears to 
be counter to the Triple Aim: improving the patient experience of care 
(including quality and satisfaction); improving the health of 
populations; and reducing the per capita cost of health care.
    Response: We disagree that the PDGM diminishes or devalues the 
clinical importance of therapy. The musculoskeletal and neurological 
rehabilitation groups under the PDGM recognize the unique needs of 
patients with musculoskeletal or neurological conditions who require 
therapy as the primary reason for home health services. For the other 
clinical groups, we note that the 30-day base payment amount includes 
therapy services, even if the primary reason for home health is not for 
the provision of therapy. The functional impairment level adjustment in 
conjunction with the other case-mix adjusters under the PDGM, aligns 
payment with the costs of providing services, including therapy.
    We agree with commenters that the role of the physical, 
occupational, and speech language pathology therapists is important in 
quality outcomes and the prevention of adverse events, such as falls 
and emergency room visits, and that these disciplines are important in 
helping patients remain in their own homes. However, we note that the 
goal of the PDGM is to provide appropriate payment based on the 
identified resource use of different patient groups; not to encourage, 
discourage, value, devalue, or promote one type of skilled care over 
another.
    We do not expect HHAs to make personnel decisions solely based on a 
change to the HH PPS case-mix methodology as the requirements for 
providing home health services have not been changed. Under the 
Medicare home health benefit, skilled professional services include 
skilled nursing services, physical therapy, speech-language pathology 
services, and occupational therapy, as specified in Sec.  409.44, and 
dependent services include home health aide services and medical social 
work services, as specified in Sec.  409.45. Skilled professionals who 
provide services to HHA patients directly or under arrangement must 
participate in the coordination of care. Additionally, we note that the 
home health CoPs at Sec.  484.60 require that each patient receive an 
individualized written plan of care that must specify the care and 
services necessary to meet the patient-specific needs as identified in 
the comprehensive assessment, including identification of the 
responsible discipline(s).
    Concerns regarding HHAs changing the way they provide services to 
eligible beneficiaries, specifically therapy services, should be 
mitigated by the more granular functional impairment level adjustment 
(for example, functional thresholds which vary between each of the 
clinical groups). The functional impairment level case-mix adjustment 
is reflective of the resource costs associated with the reported OASIS 
items and therefore ensures greater payment accuracy based on patient 
characteristics. We believe that this approach will help to maintain 
and could potentially increase access to needed therapy services. We 
remind HHAs that the provision of home health services should be based 
on patient characteristics and identified care needs. This could 
include those patients with complex and/or chronic care needs, or those 
patients requiring home health services over a longer period of time or 
for which there is no measureable or expected improvement.
    Finally, we believe that the PDGM is in alignment with the tenants 
of the CMS Triple Aim to provide better care for individuals; promote 
better health outcomes for populations; and lower health care costs. 
The PDGM does so by taking a patient-driven approach over a volume-
based approach by using patient characteristics, rather than arbitrary 
thresholds of visits that do not necessarily equate to better outcomes 
or

[[Page 56482]]

lower costs. The PDGM seeks to better define the services needed by 
home health beneficiaries. We believe that developing a case-mix system 
that provides a clearer picture as to the services provided under the 
Medicare home health benefit can help promote efficiencies in achieving 
desired patient outcomes.
    Comment: Several commenters expressed concern over how CMS would 
ensure that necessary therapy visits are provided to home heath 
beneficiaries. These commenters remarked that it is unclear how CMS 
intends to capture an accurate assessment of the services delivered 
during the home health period of care, particularly physical therapy, 
occupational therapy, and/or speech-language pathology services. Other 
comments stated that they fail to see how medical review is a 
sufficient option to remedy the consequences associated with delivering 
inadequate care, as they said that medical review does nothing that 
would allow care delivery to be modified during the period of care. A 
few commenters urged CMS to use ``accountability mechanisms,'' such as 
medical review, and recommended that the agency analyze the medical 
review findings and publically report any observed patient care trends 
via Home Health Compare.
    Response: The purpose of the changes to the case-mix adjustment 
methodology is to more accurately align home health payments with the 
costs of providing care. Other accountability mechanisms, such as 
survey and certification of HHAs, are the most appropriate ways to 
ensure quality and safety for Medicare home health recipients. Quality 
is also determined through other mechanisms, such as the HH QRP and the 
HHVBP Model.
    The new home health CoPs are more detailed in the expectations of 
the provision of needed home health services. Specifically, the CoPs at 
Sec.  484.60 require that patients are accepted for treatment on the 
reasonable expectation that an HHA can meet the patient's medical, 
nursing, rehabilitative, and social needs in his or her place of 
residence. Services are required to be identified in an individualized 
written plan of care, including any revisions or additions. The 
individualized plan of care must specify the care and services 
necessary to meet the patient-specific needs as identified in the 
comprehensive assessment, including identification of the responsible 
discipline(s), and the measurable outcomes that the HHA anticipates 
will occur as a result of implementing and coordinating the plan of 
care.
    It is difficult to proactively determine that care is 
``inadequate'' or ``of poor quality'' given that we do not know the 
type, frequency or quality of services until after those services are 
provided. The volume of services provided does not necessarily equate 
with higher quality of care.
    We believe that the home health CoPs provide the requirements to 
promote and ensure quality home health care. However, as we indicated 
in the CY 2019 HH PPS proposed rule, we will continue to analyze 
utilization trends, including therapy visits as reported on home health 
claims, to identify any issues that may warrant any quality or program 
integrity intervention.
    Comment: Some commenters expressed concerns that Medicare 
beneficiaries' functional outcomes may significantly decline following 
PDGM implementation because the provision of therapy services would be 
reduced without the extra payment for increased therapy services. These 
commenters stated that research has shown a significant correlation 
between volume of therapy and improvement in outcomes. Some commenters 
stated adoption of the PDGM could reverse the progress in patient 
outcomes that was seemingly ignited by a ``financial incentive'' to 
increase therapy visits versus skilled nursing visits.
    Response: We disagree that patients' functional outcomes would 
significantly decline following PDGM implementation. We reference a 
study conducted by RAND contrasting the effects of two payment reforms 
for home health agencies, specifically comparing the Interim 
Prospective Payment System (IPS) and the Prospective Payment System 
(PPS). This study did not show worsening patient outcomes (that is, 
increased hospitalizations or mortality) when there was a transition 
from one payment system to another (that is, from the IPS to the PPS). 
In this particular study, the analysis also showed both payment reforms 
had limited effects on costs in other post-acute settings, and limited 
effects on patient outcomes as the study noted that there was not any 
substantial increase in hospital readmissions or patient mortality 
after the implementation of the PPS.\23\ Furthermore, in its March, 
2010 report, MedPAC stated that higher home health spending is not 
yielding better outcomes. In this report, MedPAC stated that 
undesirable outcomes (for example, unnecessary complications) may 
result in additional payments, and sectors with more than adequate 
payments may have little incentive to improve quality.\24\
---------------------------------------------------------------------------

    \23\ Huckfeldt, P., Sooda, N., Escarcea, J., Grabowski, D., 
Newhouse, J. Effects of Medicare payment reform: Evidence from the 
home health interim and prospective payment systems. Journal of 
Health Economics (34) 1-18. March, 2014. https://doi.org/10.1016/j.jhealeco.2013.11.005.
    \24\ http://www.medpac.gov/docs/default-source/reports/Mar10_EntireReport.pdf.
---------------------------------------------------------------------------

    We believe that the structure of the PDGM is more patient-driven 
than the current case-mix system and more accurately represents the 
patient characteristics that will correspond to an appropriate 
individualized care plan to provide those needed services. We believe 
that the PDGM will allow for more tailored, appropriate quality of care 
and removes the financial incentive to focus on the volume of care and 
not patient needs. By keeping patient characteristics at the center of 
the case-mix adjustment methodology, we believe that patient needs will 
be more accurately addressed and that this has the potential to result 
in care plan goal achievement and desired patient outcomes.
    Comment: Another commenter remarked that using the term 
``Functional Level'' with a score of low-medium-high is confusing. This 
commenter stated that this will confuse providers into believing the 
reference is to low, medium, or high functional level. It would be 
clearer to refer to this measure as a ``Functional Impairment Level'' 
in which case a low, medium, or high functional impairment would be 
properly indicated.
    Response: As explained in the CY 2019 HH PPS proposed rule, a home 
health period of care receives points based on each of the responses 
associated with the proposed functional OASIS items which are then 
converted into a table of points corresponding to increased resource 
use. That is, the higher the points, the higher the functional 
impairment. As such, we agree that adding the term ``impairment'' when 
referring to the functional level adjustment is appropriate.
    Comment: A few commenters stated that the PDGM case-mix variables, 
including the functional impairment level adjustment would make it more 
difficult to manage costs and revenues for patients with high 
functional impairments. Some commenters disagreed with the removal of 
therapy thresholds as they asserted that the increased payments with 
the thresholds allowed for the provision of adequate therapy services. 
These commenters indicated that the reductions in payment for therapy 
visits would result

[[Page 56483]]

in a decrease in HHA viability and would force many HHAs to go out of 
business.
    Response: We remind commenters that the removal of therapy 
thresholds for CY 2020 and subsequent years is required by section 
1895(b)(4)(B)(ii) of the Act, as added by section 51001 of the BBA of 
2018, and therefore we are statutorily mandated to exclude therapy 
thresholds in the development of an alternate case-mix adjustment 
methodology effective January 1, 2020. We note that since 2000, under 
the Medicare home health benefit, HHAs receive a bundled payment for 
the provision of care to include skilled nursing; physical, 
occupational, and speech-language pathology therapy; medical social 
work; home health aides; and medical supplies. Under the PDGM, home 
health payments remain prospective payments similar to the current 
payment system, meaning an overall national, standardized base rate 
with case-mix adjustments. The structure of a prospective payment 
system is such that payment is based on a predetermined base rate 
regardless of the volume, frequency, or intensity of the actual 
service(s) provided. The case-mix adjustments provide additional 
payment to account for patient characteristics. As such, the overall 
payment amount is known to the HHA at the beginning of each home health 
episode and this fixed home health rate necessitates better management 
and estimation of costs and payments, and helps to motivate providers 
to be more efficient in the provision of quality care. Therefore, a 
home health bundled payment allows HHAs the discretion to allocate 
resources based on their knowledge of the patient and the services 
needed to meet the goals of the individualized home health plan of 
care. This would mean that the HHA would consider the most appropriate 
and efficient use of home health services based on patient needs. A 
bundled payment reduces the uncertainty in payment, affording the HHA 
more information to help manage revenues and costs in order to allocate 
resources accordingly.
    Additionally, the Medicare home health benefit requires a 
multidisciplinary approach to care and the expectation is that HHAs 
provide the full range of services under the benefit to all eligible 
beneficiaries, and not solely therapy services. As such, developing a 
business model designed to target only those patients requiring therapy 
in order to maximize Medicare payment is counter to the requirements 
under the benefit. It also places the HHA at financial risk if payment 
is reliant only on a specific patient population. For those HHAs who do 
provide the full range of services and do not target only those 
patients for whom they can maximize payment based on therapy 
thresholds, we believe that the functional impairment level adjustment 
provides sufficient additional payment across all clinical groups. This 
would include those patients who are receiving home health services 
primarily for other skilled needs but who may also require therapy 
services as part of their home health plan of care. The PDGM is 
clinically-based, meaning it relies more heavily on patient 
characteristics to place home health periods of care into clinically 
meaningful payment categories. These patient characteristics also help 
home health clinicians differentiate between the services needed by 
home health patients. We believe that a patient-driven approach to 
case-mix adjusting payment better clarifies the services provided under 
the Medicare home health benefit. Therefore, we believe this patient-
driven approach better promotes efficiencies in the provision of care 
based on actual patient needs and will make it easier for HHAs to 
manage revenues and costs.
    Finally, to support HHAs in evaluating the effects of the proposed 
PDGM, CMS is providing, upon request, a Home Health Claims-OASIS 
Limited Data Set (LDS).\25\ Additionally, CMS has posted an interactive 
PDGM Grouper Tool on the HHA Center web page that will allow HHAs to 
determine case-mix weights for their patient populations.\26\
---------------------------------------------------------------------------

    \25\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html.
    \26\ https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
---------------------------------------------------------------------------

    Comment: Several commenters stated that inclusion of caregiver 
availability and support should be part of the functional level payment 
adjustment in the PDGM because they report that a lack of caregiver 
support plays a significant role in a patient's overall functional 
level and resource needs especially as they relate to ADLs and IADLs. 
Another commenter remarked that research has shown non-compliance and 
readmission risk is higher when other psychosocial factors are present. 
Several commenters recommended that the functional level include OASIS 
items related to social determinants of health, such as those 
associated with caregiver support.
    Response: We understand the value of caregiver support for home 
health patients and its potential to affect resource utilization and 
the inclusion of caregiver variables has been examined several times 
since the development of the current HH PPS. As explained in the FY 
2001 HH PPS final rule (65 FR 41145), we examined the usefulness of 
caregiver factors but found them to be only minimally helpful in 
explaining or predicting resource use. We found that variables on the 
availability of a caregiver had no impact on average resource cost and 
only a modest impact after controlling for other patient 
characteristics. We stated that we recognized that adjusting payment in 
response to the presence or absence of a caregiver may be seen as 
inequitable by patients and their families. To the extent the 
availability of caregiver services, particularly privately paid 
services, reflects socioeconomic status differences, reducing payment 
for patients who have caregiver assistance may be particularly 
sensitive. Furthermore, adjusting payment for caregiver factors may 
introduce new and negative incentives into family and patient behavior. 
It is questionable whether Medicare should adopt a payment policy that 
could weaken informal familial supports currently benefiting patients 
at times when they are most vulnerable (65 FR 41145). Similarly, when 
we re-examined caregiver assistance as a potential case-mix variable in 
the CY 2008 HH PPS proposed rule to analyze the payment adequacy of the 
current four-equation model, we found that for patients without a 
caregiver, on average, episodes would be ``underpaid'' (72 FR 25361). 
However, the score to be gained by adding the variable was not large 
and the overall ability of the four-equation model to explain resource 
costs was improved only minimally by adding this variable. As such, we 
did not propose that a caregiver variable be added to the case-mix 
model at that time.
    When we re-examined the OASIS caregiver items for possible 
inclusion in the functional impairment level case-mix adjustment in the 
PDGM, we found inverse patterns in resource use (82 FR 35319). We 
examined OASIS items associated with types and sources of caregiver 
assistance and frequency of ADL/IADL assistance. These items assess the 
ability and willingness of non-agency caregivers (such as family 
members, friends, or privately paid caregivers) to provide categories 
of assistance needed by the patient, including ADL/IADL assistance, 
medication administration, and management of equipment. As responses to 
these items generally are not based on direct observation by the 
clinician conducting the assessment,

[[Page 56484]]

this presents a limitation for use in a case-mix adjustment as the 
accuracy of the responses cannot be easily validated. Patients or 
caregivers may overestimate or underestimate their ability or 
willingness to assist in the patient's care. Likewise, analysis of 
these items generally showed that an increased need for assistance had 
a negative impact on resource costs, meaning that as need for 
assistance increased, costs decreased. We believe this is clinically 
counterintuitive and, as outlined in both the Medicare Home Health 
Prospective Payment System: Case-Mix Methodology Refinements Overview 
of the Home Health Groupings Model technical report \27\ and the CY 
2018 and CY 2019 HH PPS proposed rules (82 FR 35270 and 83 FR 32340), 
we excluded any OASIS items that had a negative relationship with 
resource costs. Including these items would only serve to reduce the 
home health period of care payment. As such, the current data analysis 
findings we conducted on caregiver variables weaken the assertion that 
failure to adjust for caregiver factors could render payments 
inadequate.
---------------------------------------------------------------------------

    \27\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------

    Finally, we continue to believe that including this kind of 
variable in the case-mix system raises significant policy concerns. We 
maintain that a case-mix adjustment should not discourage assistance 
from family members of home care patients, nor should it make patients 
believe there is some financial stake in how they report their familial 
supports during their convalescence. We have concerns that adjusting 
payment in response to the absence of a caregiver would introduce 
negative incentives with adverse effects on home health Medicare 
beneficiaries.
    Comment: Several commenters recommended that cognition, pain and 
dyspnea should be included as functional level determinants as they 
affect functional performance and trajectory for improvement. Many 
commenters supported the inclusion of cognitive items as part of the 
functional case-mix adjustment, and noted that there is a correlation 
between cognitive status and functional impairment. A few commenters 
suggested that OASIS item M1242, Frequency of Pain interfering with 
Activity, should be included as part of the functional level items in 
the PDGM. These commenters stated that pain directly impacts functional 
performance. These same commenters remarked that PT and OT can directly 
reduce pain thus improving the patient's quality of life.
    Response: The current HH PPS does not use OASIS items associated 
with IADLs or cognition. We agree with commenters that the relationship 
between cognition and functional status is important and well-
documented in health care literature. We discussed our analysis and 
rationale for evaluating all of the OASIS items related to function, 
including the relationship between cognitive functioning and resource 
use, extensively in both the technical report \28\ and the CYs 2018 and 
2019 HH PPS proposed rules (82 FR 35319, 83 FR 32404). Empirically, it 
appears that cognition does impact functionality, and initially these 
items were included in the PDGM. Counterintuitively, however, resource 
use declined as cognitive status worsened. This negative relationship 
with resource use was consistent throughout all levels of cognitive 
functioning as assessed on the OASIS, including mild impairment. While 
we cannot explain this phenomenon from OASIS or home health claims 
alone, anecdotally we have heard that while cognitive impairment may 
intuitively signal increased resource use, the cognitive items are not 
currently payment items and therefore do not receive the same attention 
as the payment items when completing the OASIS. Likewise, we have 
received reports that as cognition declines, individuals often become 
more dependent on caregivers for functional tasks and thus the home 
health clinician is not performing those tasks during a visit. We 
frequently hear from clinicians that as it becomes increasingly 
difficult to teach the cognitively impaired patient how to perform 
ADLs/IADLs, teaching the caregiver to perform the functional tasks is 
more efficient or beneficial. Additionally, we have been told it that 
generally takes more time to teach and train the cognitively impaired 
patient to perform a functional task so the clinician may simply 
perform the functional task him or herself as the patient's ability to 
independently perform these tasks progressively declines. All of these 
anecdotes potentially could explain the inverse relationship between 
cognitive impairment and resource use.
---------------------------------------------------------------------------

    \28\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------

    As discussed previously, the OASIS cognitive items are not used for 
a payment adjustment under the current HH PPS, but most of the proposed 
functional items are. As commenters have stated, there is potentially 
more HHA focus on the OASIS payment items, which could explain why the 
functional items show a positive relationship to resource use while the 
cognitive items do not. As many commenters have stated and as supported 
in the research, there is a relationship between cognition and 
functional status. As such, we believe that the functional items 
included in the functional impairment level case-mix adjustment provide 
a reasonable proxy for cognitive status given their interrelatedness. 
Because of the negative relationship between the OASIS cognitive items 
and resource use, we decided not to include the items as part of the 
functional adjustment in the PDGM but will continue to analyze their 
inclusion once the PDGM is implemented.
    Similarly, we also examined pain and dyspnea OASIS items for 
inclusion in the case-mix adjustment methodology including OASIS items 
M1242, Pain and M1400, Shortness of Breath. While M1242, Pain, is used 
in the current HH PPS, this was shown to have only a minimal 
relationship with resource use in the current payment model. 
Additionally, we believe that this one item alone may not be robust 
enough to fully capture the pain presentation of the patient and its 
impact on resource utilization and therefore it was dropped from 
consideration. While M1400, Shortness of Breath, is also used in the 
current HH PPS, it too shows minimal impact on resource use. We did not 
include M1400 in the PDGM case-mix adjustment methodology because we 
believe the more granular ICD-10 codes that describe respiratory 
conditions, more accurately capture this patient characteristic. Again, 
we refer commenters to the more detailed discussion on why certain 
OASIS items were included or excluded from the model, the ``Overview of 
the Home Health Groupings Model Technical Report'' \29\ and the CY 2018 
HH PPS proposed rule (82 FR 35307).
---------------------------------------------------------------------------

    \29\ ``Overview of the Home Health Groupings Model'' technical 
report, Appendix Exhibit A7-1 on the HHA Center web page (https://ww.com.gov/center/provider-type/home-health-agency-hha-center.html).
---------------------------------------------------------------------------

    Comment: The majority of commenters agreed that the elimination of 
therapy thresholds is appropriate because of the current financial 
incentive to overprovide therapy services. However, these commenters 
believe that the functional impairment level adjustment is not an 
adequate proxy to ensure the provision of therapy services needed for 
patients requiring multiple disciplines of therapy or the frail elderly 
with multiple chronic conditions and associated functional impairment. 
A few commenters questioned whether CMS has evidence

[[Page 56485]]

that Medicare beneficiaries have received ``too much'' therapy, or that 
the functional outcomes of Medicare beneficiaries receiving home health 
services have suffered, under the current payment system. These 
commenters stated that given the ever-increasing effort to promote the 
delivery of care in the home and community settings, it is imperative 
that the Medicare program continue to incentivize providers to deliver 
care in non-facility-based settings while also ensuring that patients 
may continue to receive the highest quality of care that aligns with 
their preferences, desires, and needs.
    Response: We agree that the therapy thresholds have created an 
incentive to overprovide therapy services that are not in alignment 
with patient characteristics and care needs. Section 1895(b)(4)(B)(ii), 
as added by section 51001 of the BBA of 2018, requires that CMS 
eliminate the use of therapy thresholds as part of the case-mix 
adjustment methodology beginning in CY 2020. We note that the purpose 
of the functional impairment level case-mix adjustment is not meant to 
act as a direct proxy to replace the current therapy thresholds. As 
noted, the presence of the therapy thresholds provided an incentive to 
overprovide services and their removal deflates that financial 
incentive to help ensure that therapy services are based on actual 
patient needs. However, we recognized that in order to account for 
levels of functional impairment and to help ensure that necessary 
therapy services are provided, the development of a functional 
impairment level case-mix adjustment with more granularity was 
necessary. We believe that the three PDGM functional impairment levels 
in each of the 12 clinical groups are designed to encourage therapists 
to determine the appropriate services for their patients in accordance 
with identified needs rather than an arbitrary threshold of visits.
    The PDGM has other case-mix adjustments in addition to the 
functional impairment level to adjust payment for those patients 
requiring multiple therapy disciplines or those chronically ill 
patients with significant functional impairment. We believe that also 
accounting for timing, source of admission, clinical group (meaning the 
primary reason the patient requires home health services), and the 
presence of comorbidities will provide the necessary adjustments to 
payment to ensure that care needs are met based on actual patient 
characteristics.
    To address comments about evidence regarding ``too much'' therapy, 
we remind commenters that analysis has repeatedly shown that the 
current HH PPS therapy thresholds promote the provision of care based 
on increased payment associated with each of these thresholds as 
opposed to actual patient needs. In the CY 2018 HH PPS proposed rule, 
analysis of home health claims shows that the average episode payment 
by the number of therapy visits for episodes with at least one therapy 
visit increases sharply just over payment thresholds at 6, 7, and 16 
(82 FR 35276).
    Furthermore, CMS analysis demonstrates that the average share of 
therapy visits across all 60-day episodes of care increased from 9 
percent of all visits in 1997, prior to the implementation of the HH 
PPS (see 64 FR 58151), to 39 percent of all visits in 2015 (82 FR 
35276). We note that the therapy thresholds have been widely criticized 
by MedPAC who has recommended the removal of therapy thresholds for the 
past 5 years, as their analysis has repeatedly shown that Medicare 
payments for home health services have substantially exceeded costs. 
Additionally, the Senate Committee on Finance conducted an 
investigation and issued a report on therapy practices of four of the 
largest publically-traded home health agencies where three out of the 
four companies investigated encouraged therapists to target the most 
profitable number of therapy visits, even when patient need alone may 
not have justified such patterns. The Senate investigation also 
highlighted the abrupt and dramatic responses the home health industry 
has taken to maximize payment under the therapy threshold models (both 
the original 10-visit threshold model and under the revised thresholds 
implemented in the CY 2008 HH PPS final rule (72 FR 49762)). The report 
noted that, under the current HH PPS, HHAs have broad discretion over 
the number of therapy visits provided, and therefore have control of 
the single-largest variable in determining reimbursement and overall 
margins. The report recommended that CMS closely examine a future 
payment approach that focuses on patient wellbeing and health 
characteristics, rather than the numerical utilization measures.
    We agree that most patients would prefer to receive services in 
their own home whenever feasible and the Medicare home health benefit 
affords a comprehensive range of services for eligible beneficiaries. 
However, we are cognizant that payment may affect practice patterns and 
our analysis has shown that visits vary in response to financial 
incentives. While the goal of the PDGM case-mix adjustments is to align 
payment with actual patient characteristics, we are aware that practice 
patterns may shift upon implementation of a new case-mix methodology. 
Our goal is to protect patient choice and preferences as well as 
promote the provision of high quality, appropriate home care. As we 
have reiterated throughout this final rule with comment period, upon 
implementation of the PDGM, we will continue to examine the impact of 
all OASIS items on resource costs. Likewise, we will also examine any 
changes in the number of therapy visits provided that could indicate 
HHAs stinting on needed therapy services to determine whether any 
impacts warrant additional refinements to the case-mix adjustments 
under the PDGM.
    Comment: Some commenters expressed concern that eliminating the 
therapy thresholds, which dominate the current HH PPS, would cause the 
unintended consequence of shifting patients to other home health 
disciplines, specifically nursing and home health aides, which would 
steer patients away from restorative therapies and ultimately increase 
Medicare costs. Some expressed concern about other disciplines 
providing therapy services outside of the scope of their practice. Some 
expressed reservations about possible misuse of aides to provide what 
should be skilled therapy, such as providing exercise programs or 
evaluating self-care needs and safety as a substitute for skilled 
therapy. These commenters state that both substitutions are 
inappropriate and may violate state licensure law, for example, the 
provision of therapy services by unqualified personnel.
    Response: Regarding the comment that the removal of therapy 
thresholds would shift patients to other home health disciplines, we 
note that in the CY 2001 HH PPS final rule, we expressed concern over 
using a therapy utilization measure to determine home health payment 
because it could be susceptible to manipulation and may cause a shift 
away from home health nursing and other services. In this same rule, 
commenters expressed concern that implementing a therapy threshold 
would divert utilization of the home health benefit away from the frail 
elderly and in favor of the short-term patient (65 FR 41149). These 
concerns about the impact of the introduction of the therapy thresholds 
are the same concerns now expressed by commenters regarding the impact 
of the elimination of the therapy thresholds. In the CY 2001 rule, we 
stated that we would continue to review the use of a utilization 
variable in the payment

[[Page 56486]]

system over the long-term. As discussed previously in this section, 
there was a noted shift to increased therapy services after the 
implementation of the HH PPS with the therapy thresholds. We believe 
that the elimination of the therapy thresholds will remove the 
financial incentive to provide therapy solely for increased payment. As 
we are not adding any service utilization measure for nursing or home 
health aides, this would mitigate the financial incentive to provide 
more of those services solely for increased payment as well. 
Essentially, this would mean that no one home health discipline is 
favored or paid differently than any other discipline within the home 
health bundled payment and the plan of care would be patient-centered 
as opposed to payment-centered. We believe that elimination of the 
therapy thresholds is more in alignment with the intent of the home 
health benefit to be patient-centered and based on patient 
characteristics, such as functional status, and actual patient needs. 
Likewise, we expect that any services provided would be in accordance 
with all Federal and State laws, including all licensure requirements. 
The provision of skilled therapy services as part of a home health plan 
of care must also adhere to the home health CoPs, and substituting a 
home health aide to provide those skilled therapy services would be a 
violation of the CoPs (42 CFR 484.32).
    We note that the goal of the PDGM is to provide appropriate payment 
based on the identified resource use of different patient groups; not 
to encourage, discourage, value, devalue, or promote one type of 
skilled care over another. Because there are no service utilization 
thresholds in the PDGM, we expect that HHAs will respond by adapting a 
business model based on more patient-centered care as opposed to 
payment-driven care.
    Comment: Several commenters stated that the PDGM would reward 
inefficiency but not high quality outcomes by redistributing payments 
away from services such as physical, occupational and speech therapy. 
They remarked that this shift would make it harder for patients with 
high functional impairment to achieve quality outcomes.
    Response: The intent of the PDGM is to more accurately apportion 
payment with the costs of providing care. We disagree that the 
redistribution of payments would reward inefficiency as the home health 
agency is already tasked with developing efficiencies within the 
current home health bundled payment. Additionally, the home health 
quality reporting program (HH QRP), and the HH VBP Model contain 
outcome measures which are used, respectively, for the Home Health star 
ratings and a total performance score used to tie payments to quality 
performance for HHAs in certain states. As such, we believe that both 
the HH QRP and the HH VBP Model help to promote and ensure quality 
outcomes, whereas the PDGM is the mechanism for payment for services 
provided. Furthermore, regardless of level of functional impairment, we 
expect that HHAs always strive for efficiency and high quality outcomes 
for their patients. This is achieved through the appropriate provision 
of services in accordance with patient characteristics and physician 
orders as documented on the home health plan of care.
    Final Decision: After review of public comments, we are finalizing 
the use of OASIS items: M1800, M1810, M1820, M1830, M1840, M1850, M1860 
and M1033 for the functional impairment level case-mix adjustment under 
the PDGM. We are finalizing that a home health period of care receives 
points based on each of the responses associated with the functional 
OASIS items which are then converted into a table of points 
corresponding to increased resource use (see Table 28). The sum of all 
of these points results in a functional score which is used to group 
home health periods into a functional level with similar resource use. 
We are finalizing three functional levels of low impairment, medium 
impairment, and high impairment with approximately one third of home 
health periods from each of the clinical groups within each functional 
impairment level (see Table 29). For the implementation of the PDGM in 
CY 2020, we will update the functional points and functional thresholds 
as previously described based on analysis of CY 2018 home health 
claims, and using the most current version of the OASIS data set, to 
reflect any changes in resource use associated with these variables. 
Likewise, as articulated in the proposed rule and throughout this final 
rule with comment period, once the PDGM is implemented in CY 2020, we 
will continue to analyze the impact of all of the PDGM case mix 
variables to determine if any additional refinements need to made to 
ensure that all variables used as part of the overall case-mix 
adjustment appropriately align home health payment with the actual cost 
of providing home health care services.
8. Comorbidity Adjustment
    The proposed PDGM groups home health periods based on the primary 
reason for home health care (principal diagnosis), functional level, 
admission source, and timing. To further account for differences in 
resource use based on patient characteristics, we proposed to use the 
presence of home health specific comorbidities as part of the overall 
case-mix adjustment under the PDGM. The home health-specific 
comorbidity list is based on the principles of patient assessment by 
body systems and their associated diseases, conditions, and injuries to 
develop larger categories of conditions that identified clinically 
relevant relationships associated with increased resource use. These 
broad, body system-based categories we proposed to use to group 
comorbidities within the PDGM included the following:
     Heart Disease.
     Respiratory Disease.
     Circulatory Disease and Blood Disorders.
     Cerebral Vascular Disease.
     Gastrointestinal Disease.
     Neurological Disease and Associated Conditions.
     Endocrine Disease.
     Neoplasms.
     Genitourinary and Renal Disease.
     Skin Disease.
     Musculoskeletal Disease or Injury.
     Behavioral Health (including Substance Use Disorders).
     Infectious Disease.
    These broader categories were further refined into comorbidity 
subcategories to more accurately capture differences in resource use. 
All of the comorbidity diagnoses grouped into these comorbidity 
categories and subcategories are posted on the Home Health Agency web 
page and listed in the HHGM technical report, ``Medicare Home Health 
Prospective Payment System: Case-Mix Methodology Refinements Overview 
of the Home Health Groupings Model'', at the following link: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
    We originally proposed in the CY 2018 HH PPS proposed rule that if 
a period had at least one secondary diagnosis reported on the home 
health claim that fell into one of the proposed body-system based 
subcategories listed in that rule, the period would receive a 
comorbidity adjustment to account for higher costs associated with the 
comorbidity (82 FR 35309). A period would receive only one comorbidity 
adjustment regardless of the number of secondary diagnoses reported on 
the home health claim that fell into one of the subcategories. We 
received comments supporting the inclusion of a comorbidity adjustment, 
but the

[[Page 56487]]

majority of commenters also stated that the presence of multiple 
comorbidities has more of an effect on home health resource use than a 
single comorbidity. We agreed with commenters that the relationship 
between comorbidities and resource use can be complex and that a single 
adjustment, regardless of type or number of comorbidities, may be 
insufficient to fully capture the resource use of a varied population 
of home health beneficiaries. A TEP was convened and we conducted 
additional analyses on methodologies for incorporating multiple 
comorbidity adjustments into the PDGM. There was general agreement that 
most home health patients have multiple conditions which increase the 
complexity of their care and affects the ability to care for one's self 
at home (83 FR 32375).
    Taking these comments into consideration, CMS conducted additional 
analysis on the effect of comorbidities on resource utilization during 
a home health period of care. The goal of our analyses was to identify 
those clinically and statistically significant comorbidities and 
interactions that could be used to further case-mix adjust a 30-day 
home health period of care. In the CY 2019 HH PPS proposed rule, we 
described the methodology used to identify, group, and appropriately 
weight comorbidity subgroups and interactions between subgroups (83 FR 
32375). As a result of these analyses, we identified that there were 
certain individual comorbidity subgroups and interactions of the 
comorbidity subgroups (for example, having diagnoses associated with 
two of the comorbidity subgroups) which could be used as part of the 
comorbidity case-mix adjustment in the PDGM. This meant that patients 
with certain comorbidities and interactions of certain comorbid 
conditions have home health periods of care with higher resource use 
than home health periods of care without those comorbidities or 
interactions. Specifically, we identified individual comorbidity 
subgroups that were statistically and clinically significant for case-
mix adjustment and these are identified in Table 30. From the 
individual comorbidity subgroups, we then identified a subset of 
statistically and clinically significant comorbidity interactions for 
case-mix adjustment and these are identified in Table 31.
    In the CY 2019 HH PPS proposed rule, we proposed three mutually 
exclusive levels of comorbidity case-mix adjustment that depend on the 
presence of certain secondary diagnoses codes: No Comorbidity 
Adjustment, Low Comorbidity Adjustment, and High Comorbidity 
adjustment. We proposed that home health 30-day periods of care can 
receive a comorbidity payment adjustment under the following 
circumstances:
     Low comorbidity adjustment: A 30-day period of care would 
receive a low comorbidity adjustment if there is a reported secondary 
diagnosis that falls within one of the home-health specific individual 
comorbidity subgroups, as listed in Table 30, for example, Heart 11, 
Cerebral 4, etc., associated with higher resource use, or;
     High comorbidity adjustment: A 30-day period of care would 
receive a high comorbidity adjustment if a 30-day period has two or 
more secondary diagnoses reported that fall within one or more of the 
comorbidity subgroup interactions, as listed in Table 31, for example, 
Heart 11 plus Neuro 5, that are associated with higher resource use.
    A 30-day period would receive no comorbidity adjustment if no 
secondary diagnoses exist or none meet the criteria. A 30-day period of 
care can receive only one comorbidity adjustment--low or high--
regardless of the number of subgroups or subgroup interactions. We 
proposed that the low comorbidity adjustment amount would be the same 
across the individual subgroups and the high comorbidity adjustment 
would be the same across the subgroup interactions. Table 46 in the CY 
2019 HH PPS proposed rule showed the average resource use by 
comorbidity adjustment (83 FR 32411).
    With dividing the MMTA clinical group into subgroups as finalized 
in section III.E.6 of this final rule with comment period, we note that 
the number of comorbidity subgroups in both the low and high 
comorbidity adjustment is higher than as described in the CY 2019 HH 
PPS proposed rule. This more recent analysis of CY 2017 home health 
claims results in 13 comorbidity subgroups which would receive the low 
comorbidity adjustment and 34 comorbidity subgroup interactions which 
would receive the high comorbidity adjustment (see Tables 30 and 31).
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    We solicited comments on the comorbidity case-mix adjustment in the 
PDGM, which includes three comorbidity levels: No Comorbidity, Low 
Comorbidity, and High Comorbidity Adjustment. We also invited comment 
on the payments associated with the Low and High Comorbidity Adjustment 
to account for increased resource utilization resulting from the 
presence of certain comorbidities and comorbidity interactions. These 
comments are summarized in this section along with our responses.
    Comment: The majority of commenters were generally supportive of 
the change in the comorbidity adjustment in the PDGM to include both a 
low and high comorbidity adjustment and believe that adding the Low and 
High Comorbidity adjustment will yield a more accurate and robust 
payment that accounts for the additional resource intensity needed to 
care for patients with multiple comorbidities. Commenters stated that 
it is appropriate to examine the relationship of reported comorbidities 
on resource utilization to ensure that payment is in alignment with the 
actual costs of providing care. Several commenters encourage ongoing 
monitoring to ensure that subcategories of diagnoses and associated 
comorbidity payment adjustments remain appropriate and adequate. 
Several commenters believe the comorbidity adjustment should be 
expanded since as proposed it would only apply to only a small 
proportion of patients compared to the number of home health patients 
with multiple chronic conditions. This would result in providers facing 
financial difficulty in caring for medically complex patients. A 
commenter urged us to expand the Low Comorbidity Adjustment criteria. 
Another commenter believe the comorbidity adjustment was overly 
simplistic and that it should incorporate social determinants of 
health. The commenter also suggested inclusion additional comorbidity 
adjustments levels, including moderate and very high.
    Response: We thank the commenters for their support regarding a 
comorbidity case-mix adjustment that accounts for the interaction 
between multiple comorbid conditions. We believe that this change for 
the PDGM (compared to the comorbidity adjustment proposed under the 
HHGM) addresses stakeholder comments regarding the impact of the 
presence of multiple comorbidities and their interactions on resource 
utilization. This change also helps to ensure that payment is more in 
alignment with the actual costs of providing care.
    We agree that continued monitoring is needed to understand how the 
PDGM, including the comorbidity adjustment, affects home health 
patients and providers and inform future refinements. While we are 
aware of the prevalence of comorbidities in the Medicare home health 
population, we note that the average number of comorbidities in the 
aggregate becomes the standard within that population for the purpose 
of payment. For example, if the Medicare home health patient population 
has an average of three comorbidities then this is already factored 
into the base rate given that this rate represents the average home 
health payment for the average patient. The case-mix adjustment process 
recognizes increased resource use beyond the average. If the 
``average'' patient under home health is multi-morbid, then additional 
resource use is not evident as the data reflects this average.
    As noted in the CY 2019 HH PPS proposed rule, the comorbidity 
subgroups were selected through a stepwise process that identified 
clinically and statistically meaningful diagnosis-based comorbidity 
groups that were associated with higher resource use than the average 
or that would be indicated by examining clinical and functional groups, 
admission source, and timing characteristics. As such, the comorbidity 
subgroups were meant to identify only those cases when resource use was 
higher than the median when accounting for other attributions of the 
patient. A similar process was used to identify the comorbidity 
subgroup interactions that would result in a high comorbidity 
adjustment. We agree that social determinants of health is an important 
consideration in providing effective patient-centered health care, and 
we thank the commenter for raising this point. However, the comorbidity 
adjustment in the PDGM is meant to capture clinical conditions that are 
present that affect resource utilization under a home health plan of 
care.
    We anticipate that we would annually recalibrate the PDGM case-mix 
weights, which would include the comorbidity adjustment. This would be 
similar to the annual recalibration of case mix weights under the 
current HH PPS. Therefore, this could mean additions or subtractions of 
comorbidity subgroups and/or comorbidity subgroup interactions in the 
low and/or high comorbidity adjustment groups in the future. We will 
continue to analyze and monitor reported secondary diagnoses to inform 
the need for any future refinements to the comorbidity adjustment under 
the PDGM.
    Comment: Some commenters remarked that the comorbidity adjustment 
would provide insufficient payment for providers and that not enough 
periods of care would receive a comorbidity adjustment even though the 
treatment of home health patients with comorbidities is commonplace. 
Another commenter stated that the average amount of $35 for low 
comorbidity adjustment and $350 for high comorbidity adjustment is out 
of sync

[[Page 56490]]

with the costs of serving these complex beneficiaries. Another 
commenter stated that the comorbidity adjustment is not adequate to 
cover ancillary services. These same commenters wrote that this would 
expose a high proportion of HHAs to additional risk and recommended 
that CMS return to its' comorbidity payment adjustment as proposed 
under the HHGM in the CY 2018 HH PPS proposed rule or to expand both 
the application and the value of the PDGM's low comorbidity adjustment 
so that it would more fully cover the frequent instances in which more 
complex care is provided to those beneficiaries with comorbid 
conditions.
    Response: The payments associated with the low and high comorbidity 
adjustment are the result of actual resource utilization as reported on 
home health claims. As detailed in both the CY 2018 HH PPS proposed 
rule (82 FR 35322) and the CY 2019 HH PPS proposed rule (83 FR 32407), 
we analyzed home health claims to determine the actual resource 
utilization associated with the presence of certain comorbid 
conditions. We remind commenters that the additional diagnoses used for 
analysis are reported by the HHAs themselves and therefore we could 
only analyze those comorbidities reported, whether or not beneficiaries 
receiving home health care had other, unreported conditions that 
potentially could have affected resource utilization. Regardless, the 
payment amount proposed for the low and high comorbidity adjustment is 
driven by the actual resource utilization as identified on home health 
claims and therefore we believe to be sufficient to align the 
comorbidity adjustment to the costs of providing care. Likewise, the 
difference in payment between the low and the high comorbidity 
adjustment is reflective of the resource use between those patients 
with individual comorbid conditions and those with multiple comorbid 
conditions. This is also in alignment with what commenters and the TEP 
that was convened in February 2018 stated in regards to the more 
complex needs of patients who have multiple comorbidities.
    We disagree with commenters who stated that not enough periods of 
care would receive the comorbidity adjustment. To better ensure that 
reported conditions represented an actual impact on resource use, the 
proposed comorbidities include those conditions that represent more 
than 0.1 percent of periods and have at least as high as the median 
resource use as they indicate a direct relationship between the 
comorbidity and resource utilization. Under the PDGM, this approach 
increases the 30-day periods of care that would receive a comorbidity 
adjustment compared to the approach proposed in the CY 2018 HH PPS 
proposed rule. Under the proposed PDGM, almost 40 percent of home 
health periods of care would receive a low or high comorbidity 
adjustment compared to approximately 15 percent of home health periods 
under the HHGM. We believe a more granular approach to the comorbidity 
adjustment more accurately represents patient characteristics and more 
accurately aligns payments with the cost of providing care. Again, we 
remind commenters that the comorbidity adjustment is just one of the 
case-mix variables in the PDGM made in addition to the base payment and 
adjustments made for clinical and functional status, admission source, 
and timing. These variables work in tandem to account for the 
complexity of patient care needs and to make payment for home health 
services accordingly. Similarly, the HH PPS is a bundled payment to 
cover all home health services, including ancillary services such as 
home health aides. HHAs are expected to provide the services, including 
the disciplines responsible for providing those services, in accordance 
with the home health plan of care.
    We disagree that this approach to a comorbidity adjustment exposes 
HHAs to additional risk. In the CY 2001 HH PPS final rule, commenters 
stated that patients with multiple diagnoses should be credited with 
additional points in their clinical dimension measurement given the 
impact of comorbidities on resource use (65 FR 41153). We stated that 
time constraints and the data available during the development of the 
HH PPS was not robust enough for the inclusion of a comorbidity 
variable as part of the HH PPS case-mix adjustment (65 FR 41153). We 
also reiterated that we would consider comorbidities for future case-
mix analyses and that such an effort would be significantly aided by 
complete four-digit and 5-digit diagnosis coding on the OASIS record. 
In the CY 2008 HH PPS final rule (72 FR 49772), we added secondary 
diagnoses and their interactions with the principal diagnosis as part 
of the clinical dimension in the overall case-mix adjustment. However, 
analysis since that time has shown that nominal case-mix growth became 
an ongoing issue resulting from the incentive in the current HH PPS to 
code only those conditions associated with clinical points even though 
the data did not show an associated increase in resource utilization. 
For CY 2018, there was a 0.97 percent reduction to the national, 
standardized 60-day payment rate to account for nominal case-mix growth 
between CY 2012 and CY 2014. Therefore, during the development of the 
PDGM, we sought to mitigate nominal case-mix growth and looked at 
different ways to account for comorbidities in the overall case-mix 
adjustment. The description of the initial comorbidity analysis for an 
alternate case-mix methodology is included in the technical report, 
``Overview of the Home Health Groupings Model'' found on the HHA Center 
web page.\30\
---------------------------------------------------------------------------

    \30\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------

    Comment: A commenter expressed concern that underlying mood 
disorders, cognitive impairments and other behavioral issues may be 
underreported and therefore not prevalent enough to be represented in a 
comorbidity subgroup. The commenter further noted that current 
guidelines state that clinicians should list diagnoses that support the 
disciplines and services provided, which appears contrary to current 
guidance to report any and all diagnoses the patient has whether or not 
they are related to treatment indicated in the plan of care.
    Response: Behavioral Health Care is one of the PDGM clinical 
groupings, and as such, principal diagnoses related to these conditions 
are already incorporated into the case-mix weight. HHAs already should 
be reporting any and all secondary diagnoses on the plan of care that 
affect resource use, including diagnoses related to cognitive and 
behavioral issues. We agree that coding guidelines are clear that 
additional (secondary) diagnoses are only to be reported if they are 
conditions that affect patient care in terms of requiring clinical 
evaluation; or therapeutic treatment; or diagnostic procedures; or 
extended length of hospital stay; or increased nursing care and/or 
monitoring. We do not expect that HHAs would report comorbid conditions 
that are not being addressed in the individualized plan of care. The 
home health CoPs at Sec.  484.60 state that the plan of care must 
specify the care and services necessary to meet the patient-specific 
needs as identified in the comprehensive assessment, which would 
include all pertinent diagnoses.
    Comment: A commenter stated patients with comorbidities frequently 
require multiple episodes of home health care and instead of the 
comorbidity adjustment, the PDGM should have more payment groups to

[[Page 56491]]

more accurately predict resource use among patients.
    Response: We remind commenters that the subdivision of the MMTA 
clinical group into subgroups, as finalized in section III.F.6 of this 
final rule with comment period, results in 432 payment groups in the 
PDGM. Therefore, we believe that the presence of more clinical groups 
better describes patient characteristics and care needs which will 
translate to more accurate payment. Likewise, adjusting a home health 
period of care payment to account for the presence of comorbidities 
will help to more accurately pay for those patients with chronic, 
comorbid conditions who require multiple periods of home health care.
    Comment: We received a specific comment on the comorbidity 
subgroups where a commenter recommended that instead of having Skin 3 
and Skin 4 should be in their own separate clinical group instead of 
including them as part of the comorbidity adjustment.
    Response: The diagnoses that are in the Skin 3 and Skin 4 
comorbidity subgroups are already included in the Wounds clinical group 
and therefore are already accounted for in a separate clinical group. 
We believe it is important, clinically, to retain these two subgroups 
in the comorbidity adjustment as these can be conditions found in 
patients who are primarily receiving home health services for other 
reasons. For example, a patient who has recently suffered from a stroke 
with significant functional deficits and developed a pressure ulcer 
would likely be appropriately grouped into the Neuro Rehab group. 
Having these comorbidity subgroups which represent the presence of 
chronic wounds and/or pressure ulcers would provide additional payment 
to account for the complex care needs of a patient receiving Neuro 
Rehab services and who also has a wound. However, we will continue to 
reexamine reported secondary diagnoses upon implementation of the PDGM 
to see which conditions are associated with increased resource use and 
will make any refinements, as necessary, to more accurately align 
payment with patient characteristics and costs.
    Comment: Another commenter stated that with the adoption of ICD 10-
CM, HHAs have been instructed through coding guidance to code all 
diagnoses that impact the patient's care and that it is not uncommon to 
fill all 25 code fields on the claim. This commenter remarked that 
Direct Data Entry (DDE) only considers the first 9 codes on the 
patient's claim and therefore would limit payment for those periods of 
care if there are any comorbidities listed beyond the first 9 diagnosis 
fields on the claim.
    Response: We remind commenters that the DDE supports 25 diagnoses 
just like the electronic 837I claim format. The difference between the 
DDE and the electronic formats is that for the DDE format, the 
reporting of diagnosis codes is split between two screens, meaning the 
first 9 diagnosis codes are entered on the first screen, and diagnosis 
codes 10-25 are entered on the second screen. To reach the second 
screen to enter these codes, the person entering the claim information 
would hit the F6 key to move from the first screen to the second 
screen.
    Final Decision: After considering the public comments, we are 
finalizing the comorbidity adjustment as part of the overall case mix 
in the PDGM. To summarize, this includes the home health specific list 
of comorbidity subgroups and comorbidity subgroup interactions. One of 
the three mutually exclusive categories of comorbidity adjustment will 
be applied to each period: No Comorbidity Adjustment, Low Comorbidity 
Adjustment, and High Comorbidity Adjustment. A 30-day period of care 
can receive payment for a low comorbidity adjustment or a high 
comorbidity adjustment, but not both. A 30-day period of care can 
receive only one low comorbidity adjustment regardless of the number of 
secondary diagnoses reported on the home health claim that fell into 
one of the individual comorbidity subgroups or one high comorbidity 
adjustment regardless of the number of comorbidity group interactions, 
as applicable. The low comorbidity adjustment amount would be the same 
across the subgroups and the high comorbidity adjustment would be the 
same across the subgroup interactions. Upon implementation of the PDGM 
in CY 2020, we will analyze the most recently available claims to 
update the comorbidity list to include those comorbid conditions and 
interaction subgroups that represent more than 0.1 percent of periods 
and have at least as high as the median resource use. Likewise, we will 
continue to evaluate reported secondary diagnoses and interactions 
between comorbidities to identify their impact on resource costs to 
determine if any additional refinements to this case-mix adjustment 
variable are warranted.
9. Change in the Low-Utilization Payment Adjustment (LUPA) Threshold
    Currently, 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). While the proposed 
PDGM system in the CY 2019 HH PPS proposed rule would still include 
LUPA payments, the approach to calculating the LUPA thresholds needed 
to change due to the proposed change in the unit of payment to 30-day 
periods of care from 60-day episodes. We note that in the current 
payment system, approximately 8 percent of episodes are LUPAs. Under 
the PDGM, the 30-day periods of care have substantially more periods 
with four or fewer visits than 60-day episodes. Therefore, to create 
LUPA thresholds under the PDGM, in the CY 2019 proposed rule (82 FR 
32411), we proposed to set the LUPA threshold at the 10th percentile 
value of visits or 2 visits, whichever is higher, for each payment 
group in order to target approximately the same percentage of LUPAs. 
This resulted in approximately 7.1 percent of 30-day periods that would 
be LUPAs (assuming no behavior change) under the PDGM. We also proposed 
that the LUPA thresholds for each PDGM payment group would be re-
evaluated every year based on the most current utilization data 
available.
    We received several comments on the LUPA threshold methodology 
proposed for the PDGM and these are summarized in this section with our 
responses:
    Comment: Several commenters agreed in concept with the proposed 
changes to the LUPA threshold, but stated that additional time is 
necessary to fully evaluate the model's impact, especially in 
conjunction with the transition from a 60-day to a 30-day payment 
period. Several commenters requested a more cautious approach of 
delayed implementation, to allow providers and software vendors an 
opportunity to prepare for implementation of the new thresholds.
    Response: We appreciate commenters agreeing that LUPA thresholds 
should vary by clinical group. LUPA thresholds that vary by case-mix 
group level take into account different resource use patterns based on 
clinical characteristics and is a more patient-driven approach. We note 
that we will implement the PDGM for home health periods of care 
starting on or after January 1, 2020, giving HHAs and vendors 
sufficient time to evaluate the impact of the PDGM and make necessary 
changes to their software systems to accommodate a 30-day unit of 
payment and the varying LUPA threshold approach.
    Comment: Many commenters expressed concern that creating

[[Page 56492]]

different LUPA thresholds, in which the thresholds vary from 2-6 
minimum visits, depending on the home health grouping, will greatly 
increase the complexity of the payment system, administrative burden, 
and costs to agencies. Several commenters suggested maintaining the use 
of a single LUPA threshold. Other commenters suggested a system of 
varying LUPA thresholds (that is, more than one), but more simplified 
to include a narrower range of thresholds than the proposed 2-6 
thresholds. Commenters recommended that any LUPA threshold options 
should be fully evaluated for potential impacts, including behavioral 
changes that could affect patient access to care.
    Response: The concept of case-mix adjusted LUPA thresholds is not 
new. In the FY 2001 HH PPS final rule (42 FR 41143), when the LUPA 
threshold of four or fewer visits was introduced, commenters suggested 
that CMS instead use specific LUPA thresholds for each HHRG. We are 
unsure why case-mix-specific LUPA thresholds would result in additional 
administrative burden and costs. We note that under the current HH PPS, 
LUPA episodes are billed the same as a non-LUPA episodes and this will 
not change under the PDGM where LUPA periods of care will be billed the 
same way as non-LUPA 30-day periods of care. We are unsure why case-mix 
group specific LUPA thresholds would impact patient access and 
commenters did not provide any additional information to inform such 
assertions. While some commenters suggested a system of varying LUPA 
thresholds (that is, more than one), but more simplified to include a 
narrower range of thresholds than the proposed 2-6 thresholds, they did 
not provide specifics on their recommendation nor any rationale for 
this suggestion. However, we remind commenters that we set the LUPA 
threshold at the 10th percentile value of visits or 2 visits, whichever 
is higher, for each payment group in order to target approximately the 
same percentage of LUPAs as under the current system. Therefore, we 
believe this approach to be the most reasonable. However, we will 
analyze this methodology once the PDGM is implemented in CY 2020 to 
determine whether any changes to the LUPA thresholds are warranted.
    Comment: Several commenters expressed concern that this policy 
change could increase the number of LUPAs, which present a financial 
loss for agencies. A commenter remarked that a 60-day episode under the 
current system with 14 visits would potentially become two 30-day LUPAs 
under the proposed PDGM.
    Response: As explained in the CY 2019 HH PPS proposed rule (83 FR 
32412), our methodology for determining LUPA assignment was calibrated 
to target approximately the same rate of LUPA occurrences as under the 
current HH PPS case-mix system. Based on our analysis of CY 2017 home 
health utilization data, under the PDGM, a slightly lower rate of 30-
periods would be assigned as LUPAs (approximately 7%) than 60-day 
episodes under the current payment system (approximately 8%). We 
believe that targeting approximately the same percentage of LUPA 
periods under the PDGM as the current HH PPS should mitigate HHA 
concerns of an increased number of LUPA periods of care and we do not 
believe this approach would create a financial hardship for HHAs.
    Comment: A commenter questioned the methodology of the LUPA 
threshold calculation. They suggested that low counts of visits due to 
the patient's death or transfer to another agency are not comparable 
with counts of low visits due to patient needs and thereby these two 
situations at least should be excluded when determining the thresholds.
    Response: While we appreciate the commenter's suggestion, when we 
examined the data, we found the combined occurrences of patient deaths 
or transfers to another agency did not impact the threshold numbers.
    Comment: Another commenter expressed concern about how the change 
to the LUPA thresholds under the PDGM would affect the provision and 
payment of Non-Routine Supplies (NRS). The commenter cited an example 
of periods of care classified under the Wound clinical group for which 
the commenter noted use disproportionately greater amounts of NRS, and 
questioned whether the per-visit rates alone would be sufficient to 
recoup costs. Another commenter noticed that, with some groupings and 
all else equal, the threshold amounts can be seen to rise and then fall 
with functional level and thereby the thresholds were not consistent 
with patient needs.
    Response: We remind commenters that payment for NRS has been 
included in the per-visit LUPA rates since the implementation of the HH 
PPS (65 FR 41128). At that time, commenters expressed concern that the 
per-visit LUPA rates would not adequately compensate for NRS and the 
per visit payment rates were updated to reflect those concerns (65 FR 
41138). In the CY 2014 HH PPS final rule (72 FR 72280), we rebased the 
national, per-visit payment amounts the highest amounts allowed by law. 
Under the PDGM, the LUPA thresholds are data-driven and determined 
based on the visit patterns reflected in each of the case-mix groups. 
Any noted patterns of LUPA thresholds varying with functional level is 
the result of provider reported information on the OASIS. Accurate 
reporting on the OASIS is imperative to fully account for the level of 
impairment at the time of the assessment and to be reflective of the 
services provided. We reiterate, that in order to maintain 
approximately the same proportion of LUPA periods under the PDGM with a 
30-day unit of payment compared to the current HH PPS with a 60-day 
episode of payment, the LUPA thresholds were set at the 10th percentile 
of visits or 2 visits, whichever is higher.
    Final Decision: We are finalizing our proposal to vary the LUPA 
threshold for each 30-day period of care depending on the PDGM payment 
group to which it is assigned. Likewise, we are finalizing that the 
LUPA thresholds for each PDGM payment group will be re-evaluated every 
year based on the most current utilization data available. The LUPA 
thresholds for the PDGM payment groups with the corresponding HIPPS 
codes based on CY 2017 home health data are listed in Table 32. Since 
we propose to implement the PDGM on January 1, 2020, LUPA thresholds 
for the PDGM payment groups with the corresponding HIPPS codes for CY 
2020 will be updated in the CY 2020 HH PPS proposed rule using CY 2018 
home health data.

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10. HH PPS Case-Mix Weights Under the PDGM
    Section 1895(b)(4)(B) 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. In the CY 2019 HH PPS proposed rule 
(83 FR 32415), we proposed an alternative case-mix adjustment 
methodology to better align payment with patient care needs. The 
proposed alternative case-mix adjustment methodology places patients 
into meaningful payment categories based on patient characteristics 
(principal diagnosis, functional level, comorbid conditions, referral 
source and timing). As outlined in previous sections of this final rule 
with comment period, we are finalizing this alternative case-mix 
adjustment methodology, called the PDGM. This new methodology results 
in 432 unique case-mix groups. These 432 unique case-mix payment groups 
are called Home Health Resource Groups (HHRGs).
    To generate PDGM case-mix weights, we utilized a data file based on 
home health 30-day periods of care, as reported in Medicare home health 
claims linked to OASIS assessment data to obtain patient 
characteristics. The claims data provides visit-level data and data on 
whether non-routine supplies (NRS) was provided during the period and 
the total charges for NRS. We determined the case-mix weight for each

[[Page 56503]]

of the different PDGM payment groups by regressing resource use on a 
series of indicator variables for each of the categories using a fixed 
effects model. The regression measures resource use with the Cost per 
Minute (CPM) + NRS approach outlined in section III.F.2 of this final 
rule with comment period. The model used in the PDGM payment regression 
generates outcomes that are statistically significant.
    After best fitting the model on CY 2017 home health data, we used 
the estimated coefficients of the model to predict the expected average 
resource use of each 30-day period based on the five PDGM categories. 
In order to normalize the results, we divided the regression predicted 
resource use of each 30-day period by the overall average resource use 
used to estimate the model in order to calculate the case mix weight of 
all periods within a particular payment group, where each payment group 
is defined as the unique combination of the subgroups within the five 
PDGM categories (admission source, timing of the 30-day period, 
clinical grouping, functional impairment level, and comorbidity 
adjustment). The case-mix weight is then used to adjust the base 
payment rate to determine each period's payment. Table 48 shows the 
coefficients of the payment regression used to generate the weights, 
and the coefficients divided by average resource use. Information can 
be found in section III.F.6 of this rule for the clinical groups, 
section III.F.7 of this rule for the functional impairment levels, 
section III.F.5 for admission source, section III.F.4 for timing, and 
section III.F.8 for the comorbidity adjustment.

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    Table 34 presents the case-mix weight for each Home Health Resource 
Group (HHRG) in the regression model. LUPA episodes, outlier episodes, 
and episodes with PEP adjustments were excluded. Weights are determined 
by first calculating the predicted resource use for episodes with a 
particular combination of admission source, episode timing, clinical 
grouping, functional impairment level, and comorbidity adjustment. This

[[Page 56505]]

combination specific calculation is then divided by the average 
resource use of all the episodes that were used to estimate the 
standard 30-day payment rate. The resulting ratio represents the case-
mix weight for that particular combination of a HHRG payment group. The 
adjusted R-squared value provides a measure of how well observed 
outcomes are replicated by the model, based on the proportion of total 
variation of outcomes explained by the model.
    Similar to the annual recalibration of the case-mix weights under 
the current HH PPS, we proposed to annually recalibrate the PDGM case-
mix weights. We note that this includes a re-calculation of the 
proposed PDGM case-mix weights for CY 2020 in the CY 2020 HH PPS 
proposed rule using CY 2018 home health claims data linked with OASIS 
assessment data since we will implement the PDGM for 30-day periods of 
care beginning on or after January 1, 2020.

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    In conjunction with the implementation of the PDGM, in the CY 2019 
HH PPS proposed rule (83 FR 32420) we proposed to revise the frequency 
with which we update the HH PPS Grouper software used to assign the 
appropriate HIPPS code used for case-mix adjustment onto the claim. 
Since CY 2004 when the HH PPS moved from a fiscal year to a calendar 
year basis, we have updated the Grouper software twice a year. We 
provide an

[[Page 56515]]

updated version of the Grouper software effective every October 1 in 
order to address ICD coding revisions, which are effective on October 
1. We also provide an updated version of the HH PPS Grouper software 
effective on January 1 in order to capture the new or revised HH PPS 
policies that become effective on January 1. In an effort to reduce 
provider burden associated with testing and installing two software 
releases, we proposed to discontinue the October release of the HH PPS 
Grouper software and provide a single HH PPS Grouper software release 
effective January 1 of each calendar year. We proposed that the January 
release of the HH PPS Grouper software would include the most recent 
revisions to the ICD coding system as well as the payment policy 
updates contained in the HH PPS final rule.
    We solicited public comments on the proposed PDGM case-mix weights, 
case-mix weight methodology and proposed annual recalibration of the 
case-mix weights, updates to the HH PPS Grouper software, and the 
associated regulations text changes in section III.F.13 of this 
proposed rule. The following is a summary of the public comments on the 
case mix weight methodology under PDGM and the updates to the HH PPS 
Grouper Software and our responses:
    Comment: A few commenters urged CMS to formalize a transparent 
process and timeline to refine the case-mix weights soon after 
implementation of the PDGM, to assess whether various factors will 
influence the ability of the model to better predict resource use, such 
as additional secondary diagnoses or interactions between such 
diagnoses. The commenters noted that it is imperative that the case-mix 
weights reflect current care protocols and resource needs. A few 
commenters suggested that CMS provide further explanation of how the 
new model addresses the concerns for those patients with complex, 
chronic care needs (for example, an ALS patient is referenced). Another 
commenter questioned how the PDGM could address issues of access, since 
beneficiaries without access to home health are by definition not 
included in the analysis (which was done based on prior utilization 
records).
    Response: As noted in the CY 2019 HH PPS proposed rule (83 FR 
32416), we proposed to annually recalibrate the PDGM case-mix weights 
to reflect the most recent utilization data available at the time of 
rulemaking. Once the PDGM is finalized, we will also continue to 
analyze all of the components of the case-mix adjustment, and make 
refinements as necessary to ensure that payment for home health periods 
are in alignment with costs. We note that we provide a clinical example 
in section III.F.12 of this final rule with comment period, 
specifically relating to ALS, that shows how high cost periods of care 
could receive outlier payments under the PDGM.
    Comment: Numerous commenters agreed that the October release of the 
Grouper should be discontinued (and only the January release be 
retained) as long as HHAs would not be at risk for violating HIPAA 
rules, if the agency were to potentially use an incorrect diagnosis 
code in the last quarter of the year (incorrect in the sense that the 
coding was made obsolete by ICD-10 refinements that were not reflected 
in the Grouper until the following January). A commenter expressed 
approval at this effort to reduce burdens on HHAs (although also 
expressed concern over the issue with HIPAA rules). Another commenter 
questioned how this would impact other Medicare claims and coding, 
noting that many agencies also operate hospice businesses, and the 
situation can be confusing if hospice still operates under the Fiscal 
Year guidance whereas Home Health operates under the Calendar Year 
guidance.
    Response: We thank commenters for their support in findings ways to 
reduce regulatory burden and potentially streamlining the HH PPS 
Grouper into one annual release. However, upon further examination of 
this proposal, we recognize that this could lead to potential Health 
Insurance Portability and Accountability Act (HIPAA) violations for 
HHAs. HIPAA requires that covered entities use the current adopted code 
set (45 CFR 162.1000). If the ICD-10-CM code set is implemented in 
October then that would be the current code set and using outdated 
codes from October through the following January would be non-compliant 
with HIPAA requirements. However, in an effort to reduce provider 
burden associated with the release of two Groupers, we will continue to 
examine ways to minimize this burden. For example, if we do not update 
the functional impairment level points and thresholds on an annual 
basis, we could eliminate the need for a second Grouper release in 
January and instead update the Grouper for October 1 when ICD-10-CM 
code changes become effective. While we would continue to annually 
recalibrate the PDGM case-mix weights, we may not need to update the 
points and thresholds annually. Any changes to the Grouper releases or 
the updates to the functional points and thresholds would be proposed 
in future rulemaking.
    Final Decision: We are finalizing the PDGM, with the modifications 
previously discussed, effective for 30-day periods of care that start 
on or after January 1, 2020. Additionally, we are finalizing our 
proposal to generate PDGM case-mix weights for each of the different 
PDGM payment groups by regressing resource use on a series of indicator 
variables for each of the five categories previously listed (timing, 
admission source, clinical grouping, functional level, and comorbidity) 
using a fixed effects model and annually recalibrating the PDGM case-
mix weights to ensure that the case-mix weights reflect the most recent 
utilization data available at the time of annual rulemaking. We are not 
finalizing the discontinuation of the October release of the HH PPS 
Grouper software update given the potential for HIPAA violations. 
Therefore, we will continue to release Grouper software in both October 
and January of each year. Any proposals to discontinue any one of the 
Grouper software releases would be included in future rulemaking for 
public comment.
11. Low-Utilization Payment Adjustment (LUPA) Add-On Payments and 
Partial Payment Adjustments Under PDGM
    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. Under the PDGM, we proposed that 
the LUPA add-on factors will remain the same as the current payment 
system, described in the CY 2019 HH PPS proposed rule (83 FR 32372). We 
proposed to multiply the per-visit payment amount for the first SN, PT, 
or SLP visit in LUPA 30-day periods that occur as the only 30-day 
period or an initial 30-day period in a sequence of adjacent periods of 
care by the appropriate factor (1.8451 for SN, 1.6700 for PT, and 
1.6266 for SLP) to

[[Page 56516]]

determine the LUPA add-on payment amount.
    The current partial episode payment (PEP) adjustment is a 
proportion of the episode payment and is based on the span of days 
including the start-of-care date (the date of the first billable 
service) through and including the last billable service date under the 
original plan of care before an intervening event in a home health 
beneficiary's care defined as:
     A beneficiary elected transfer, or
     A 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.
    For 30-day periods of care, we proposed that the process for 
partial payment adjustments would remain the same as the existing 
policies pertaining to partial episode payments. When a new 30-day 
period begins due to the intervening event of a beneficiary elected 
transfer or there was a discharge and return to home health during the 
30-day period, we proposed that the original 30-day period would 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 would 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 30. The 
proportion would then be multiplied by the original case-mix and wage 
index to produce the 30-day payment.
    We solicited public comments on the LUPA add-on payments and 
partial payment adjustments proposed for the PDGM and the associated 
changes in the regulations text. The following is a summary of the 
public comments and our responses:
    Comment: Another commenter requested clarification on the use of 
the word ``episode' in the CY 2019 HH PPS proposed rule (83 FR 32421) 
and whether the first two 30-day periods (the former 60-day episode 
timeframe) would both receive the LUPA add-on payment or only the 
initial 30-day period. The commenter's expectation was that the add-on 
payment would only be paid to the initial 30-day period.
    Response: The commenter's assumption was correct; the LUPA add-on 
payment amount under the PDGM will only be paid to LUPA periods that 
occur as the only period of care or the initial 30-day period of care 
in a sequence of additional periods of care by the appropriate add-on 
factor.
    Final Decision: We are finalizing our proposal to continue to 
multiply the per-visit payment amount for the first skilled nursing, 
physical therapy, or speech-language pathology visit in LUPA periods 
that occur as the only period of care or the initial 30-day period of 
care in a sequence of adjacent 30-day periods of care by the 
appropriate add-on factor (1.8451 for SN, 1.6700 for PT, and 1.6266 for 
SLP) to determine the LUPA add-on payment amount for 30-day periods of 
care under the PDGM. We are also finalizing our proposal to retain the 
current PEP policy and apply such policy to 30-day periods of care 
under the PDGM.
12. Payments for High-Cost Outliers Under the PGDM
    As described in section III.E. of the CY 2019 HH PPS proposed rule 
(83 FR 32375), section 1895(b)(5) of the Act allows for the provision 
of an addition or adjustment to the home health payment amount in the 
case of outliers because of unusual variations in the type or amount of 
medically necessary care. The history of and current methodology for 
payment of high-cost outliers under the HH PPS is described in detail 
in section III.E. of the CY 2019 HH PPS proposed rule (83 FR 32375). We 
proposed that we would maintain the current methodology for payment of 
high-cost outliers upon implementation of the PGDM and that we would 
calculate payment for high-cost outliers based upon 30-day periods of 
care.
    As discussed in the CY 2019 HH PPS proposed rule (83 FR 32421), we 
updated our outlier estimates for this final rule with comment period. 
Simulating payments using preliminary CY 2017 claims data and the CY 
2019 payment rates, we estimated that outlier payments under the PGDM 
with 30-day periods of care would comprise approximately 4.77 percent 
of total HH PPS payments in CY 2019. Given the statutory requirement 
that estimated total outlier payments do not exceed the 2.5 percent of 
total payments (as required by section 1895(b)(5)(A) of the Act), we 
estimated that the FDL ratio under the PGDM would need to change to 
0.71 to maintain compliance with statute. However, given the 
implementation of the PGDM for 30-day periods of care beginning on or 
after January 1, 2020, we will update our estimate of outlier payments 
as a percent of total HH PPS payments using the most current and 
complete utilization data available at the time of CY 2020 rate setting 
and would propose a change in the FDL ratio for CY 2020, if needed.
    We solicited public comments on maintaining the current outlier 
payment methodology for the PGDM and the associated changes in the 
regulations text. The following is a summary of the public comments and 
our responses:
    Comment: Several commenters indicated their support for the 
proposal to continue outlier payments under the PDGM.
    Response: We thank the commenters for the support of this continued 
payment policy.
    Comment: Several commenters suggested that we develop an outlier 
policy under the PGDM that is comparable to the existing system but 
modified to reflect the change to the 30-day payment period and also 
consider further refinement to ensure a smooth transition within the 
framework of the PGDM. Another commenter expressed concern regarding 
the potential for more providers to exceed the 10 percent outlier cap 
under a 30-day period of care and also suggested modification to the 8-
hour cap on the amount of time per day that is permitted to be counted 
toward the estimation of a period's costs for outlier calculation 
purposes. A few commenters stated that they believed that the cap on 
outlier payments would prevent necessary care and cause providers to 
seek beneficiaries with profiles that could help maximize profits.
    Response: We believe that our proposal to maintain the existing 
outlier policy under the PGDM, except that outlier payments would be 
determined on a 30-day basis to align with the 30-day unit of payment 
under the PGDM, is comparable to the existing system and would ensure a 
smooth transition within the framework on the PGDM. We plan to closely 
evaluate and model projected outlier payments within the framework of 
the PGDM and consider modifications to the outlier policy as 
appropriate. We note that the maximum of 2.5 percent of outlier 
payments to total payments and the 10 percent cap on outlier payments 
at the home health agency level are statutory requirements, as 
described in section 1895(b)(5) of the Act. Therefore, we do not have 
the authority to adjust or eliminate the 10-percent cap or increase the 
2.5 percent maximum amount.
    Regarding the 8-hour limit on the amount of time per day counted 
toward the estimation of a period's costs, as noted in the CY2017 HH 
PPS final rule (81 FR 76729), where a patient is eligible for coverage 
of home health services, Medicare statute limits the amount of part-
time or intermittent

[[Page 56517]]

home health aide services and skilled nursing services covered during a 
home health episode. Section 1861(m)(7)(B) of the Act states that the 
term ``part-time or intermittent services'' means skilled nursing and 
home health aide services furnished any number of days per week as long 
as they are furnished (combined) less than 8 hours each day and 28 or 
fewer hours each week (or, subject to review on a case-by-case basis as 
to the need for care, less than 8 hours each day and 35 or fewer hours 
per week).'' Therefore, the daily and weekly cap on the amount of 
skilled nursing and home health aide services combined is a limit 
defined within the statute. As we further noted in the CY2018 HH PPS 
final rule (81 FR 76729), because outlier payments are predominately 
driven by the provision of skilled nursing services, the 8-hour daily 
cap on services aligns with the statute, which requires that skilled 
nursing and home health aide services be furnished less than 8 hours 
each day. Therefore, we believe that maintaining the 8-hour per day cap 
is appropriate under the new PGDM. However, we plan to monitor for any 
unintended results of this policy as data become available.
    Comment: Another commenter expressed concern regarding the change 
to 30-day payment periods and its impact to the outlier payment policy. 
The commenter believes that the 30-day periods and resultant adjustment 
to the fixed dollar loss ratio would then make it harder for 
beneficiaries to obtain outlier services.
    Response: As described in detail in the CY 2019 HH PPS proposed 
rule (83 FR 32340), 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 higher FDL ratio reduces the number of episodes 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. Alternatively, a lower FDL ratio means 
that more episodes can qualify for outlier payments, but outlier 
payments per episode must then be lower. As we evaluate the final 
features of the PDGM for implementation in CY 2020, we will evaluate 
and consider the potential for impacts of a modified FDL. While a 
higher FDL value would potentially lessen the number of home health 
periods that qualify for an outlier payment, those periods that did 
qualify for an outlier payment could potentially receive a 
proportionally higher outlier payment amount. Additionally, we note 
that the 2.5 percent target of outlier payments to total payments and 
the 10 percent cap on outlier payments at the home health agency level 
are statutory requirements, as described in section 1895(b)(5) of the 
Act. Moreover, the forthcoming change to the 30-day payment period is 
also statutory in that it is required by the BBA of 2018. We plan to 
closely evaluate and model projected outlier payments within the 
framework of the PDGM and consider modifications to the outlier policy 
as appropriate.
    Comment: Several commenters suggested that eligibility for an 
outlier payment be updated to include NRS costs incurred and not just 
imputed costs of service visits. Commenters asserted that the outlier 
policy under the PDGM may not adequately cover the costs of wound care 
products necessary to achieve excellent patient outcomes and 
recommended that we design a more specific model that accurately pays 
for NRS separately and establish an outlier payment model for very 
complex wound-care patients.
    Response: We appreciate the commenters' suggestion regarding the 
inclusion of supplies in the outlier calculation under the PDGM. In 
order to incorporate supply costs into the outlier calculation, 
significant claims payment systems modifications would be required. 
However, we will consider whether to add supply costs to the outlier 
calculations and evaluate whether such a policy change is appropriate 
for future rulemaking, potentially in conjunction with the 
implementation of the PDGM for CY 2020.
    Comments: Commenters requested that we develop clinical examples 
illustrating how outliers would be paid under the proposed PDGM, 
similar to the examples provided for an ALS patient under the current 
payment system in the CY 2019 HH PPS proposed rule.
    Response: In section III.D. of the CY 2019 HH PPS proposed rule (83 
FR 32340), we described a clinical example of how care for a patient 
with amyotrophic lateral sclerosis (ALS), could qualify for an 
additional outlier payment, which would serve to offset unusually high 
costs associated with providing home health to a patient with unusual 
variations in the amount of medically necessary care. Using the same 
clinical scenario, in this final rule with comment period we provide an 
example of how the provision of services per the home health plan of 
care could emerge for a beneficiary with ALS who qualifies for the 
Medicare home health benefit for the first two 30-day periods of care 
under the PDGM. We note that this example is provided for illustrative 
purposes only and does not constitute a specific Medicare payment 
scenario.
    Example One: First 30-day Period under the PDGM:
    An ALS beneficiary may be assessed by a physician in the community 
and subsequently be deemed to require home health services for skilled 
nursing, physical therapy, occupational therapy, and a home health 
aide. The beneficiary could receive skilled nursing twice a week for 45 
minutes to assess dyspnea when transferring to a bedside commode, stage 
two pressure ulcer of the sacrum, and pain status. In addition, a home 
health aide could provide services for three hours in the morning and 
three hours on Monday, Wednesday and Friday and two and a half hours in 
the morning and two and half hours in the afternoon on Tuesday and 
Thursdays to assist with bathing, dressing and transferring. Physical 
therapy services twice a week for 45 minutes could be provided for 
adaptive transfer techniques, and occupational therapy services could 
be supplied twice a week for 45 minutes for assessment and teaching of 
assistive devices for activities of daily living to prevent or slow 
deterioration of the beneficiary's condition. Because of the patient's 
condition, the first 30-day period of care would be placed into the 
community early, neuro rehabilitation, high functional impairment, and 
low comorbidity group (1BC21). For the purposes of this example, we 
assume that services are rendered per week for a total of 4 weeks per 
30-day period of care.
BILLING CODE 4120-01-P

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    For the first 30-day period of this clinical scenario under the 
PDGM, the preceding calculation illustrates how HHAs would be paid by 
Medicare for providing care to patients with higher resource use in 
their homes.
    Example Two: Second 30-day Period under the PDGM:
    For the second 30-day period under the PDGM, the ALS beneficiary 
continues to require the home health services of skilled nursing, 
physical therapy, occupational therapy and a nurse's aide. The 
beneficiary continues to receive skilled nursing twice a week to assess 
dyspnea when transferring to a bedside commode, stage two pressure 
ulcer at the sacrum, and pain status. A home health aide could provide 
services for three hours in the morning and three hours on Monday, 
Wednesday, and Friday and two and a half hours in the morning and two 
and half hours in the afternoon on Tuesday and Thursdays to assist with 
bathing, dressing, and transferring. Physical therapy services twice a 
week for 45 minutes could be provided for adaptive transfer techniques, 
and occupational therapy services could be supplied twice a week for 45 
minutes for assessment and teaching of assistive devices for activities 
of daily living to prevent or slow deterioration of the beneficiary's 
condition. Given the beneficiary's condition the second 30-day period 
of care would fall into the community late, neuro rehabilitation, high 
functional impairment, and low comorbidity group (3BC21).

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BILLING CODE 4120-01-C
    For the second 30-day period of this clinical scenario, the 
previous calculation demonstrates how outlier payments could be made 
for patients with chronic, complex conditions under the PDGM. We note 
that this example is presented for illustrative purposes only, and is 
not intended to suggest that all diagnoses of ALS should receive the 
grouping assignment or number of periods described here. The CMS 
Grouper would assign these groups based on information in the OASIS. In 
general, we expect that outlier payments for unusually high cost 
periods in PDGM will be comparable to those under the current system, 
but there may be a small increase or decrease in rates depending on 
each beneficiary's specific situation. We reiterate that outlier 
payments could provide payment to HHAs for those patients with higher 
resource use and that the patient's condition does not need to improve 
for home health services to be covered by Medicare. We appreciate the 
feedback we have received from the public on the outlier policy under 
the HH PPS and look forward to ongoing collaboration with stakeholders 
on any further refinements that may be warranted, including the 
proposed outlier methodology under the PDGM.
    Final Decision: We are finalizing our proposal to maintain the 
current methodology for payment of high-cost outliers upon 
implementation of the PGDM and that we would calculate payment for 
high-cost outliers based upon 30-day periods of care.
13. Conforming Regulations Text Revisions for the Implementation of the 
PDGM in CY 2020
    We are finalizing a number of revisions to the regulations to 
implement the PDGM for periods of care beginning on or after January 1, 
2020, as outlined in sections through III.F.1 through III.F.12 of this 
final rule with comment period. We are finalizing to make conforming 
changes in Sec.  409.43 and part 484 Subpart E to revise the unit of 
service from a 60-day episode to a 30-day period. In addition, we are 
finalizing to restructure Sec.  484.205. These revisions would be 
effective on January 1, 2020. Specifically, we are- doing the 
following:
     Revising Sec.  409.43, which outlines plan of care 
requirements. We are revising several paragraphs to phase out the unit 
of service from a 60-day episode for claims beginning on or before 
December 31, 2019, and to implement a 30-day period as the new unit of 
service for claims beginning on or after January 1, 2020 under the 
PDGM. We are moving and revising paragraph (c)(2) to Sec.  484.205 as 
paragraph (c)(2) aligns more closely with the regulations addressing 
the basis of payment.
     Revising the definitions of rural area and urban area in 
Sec.  484.202 to remove ``with respect to home health episodes ending 
on or after January 1, 2006'' from each definition as this verbiage is 
no longer necessary.
     Restructuring Sec.  484.205 to provide more logical 
organization and revise to account for the change in the unit of 
payment under the HH PPS for CY 2020. The PDGM uses 30-day periods 
rather than the 60-day episode used in the current payment system. 
Therefore, we are to revising Sec.  484.205 to remove references to 
``60-day episode'' and to refer more generally to the ``national, 
standardized prospective payment''. We are also revising Sec.  484.205 
as follows:
    ++ Adding paragraphs to paragraph (b) to define the unit of 
payment.
    ++ Moving language which addresses the requirement for OASIS 
submission from Sec.  484.210 and inserting it into Sec.  484.205 as 
new paragraph (c).
    ++ Moving paragraph (c)(2) from Sec.  409.43 to Sec.  484.205 as 
new paragraph (g) in order to better align with the regulations 
detailing the basis of payment.
    ++ Adding paragraph (h) to discuss split percentage payments under 
the current model and the PDGM.
    We are not changing the requirements or policies relating to 
durable medical equipment or furnishing negative pressure wound therapy 
using a disposable device.
     Removing Sec.  484.210 which discusses data used for the 
calculation of the national prospective 60-day episode payment as we 
believe that this information is duplicative and already incorporated 
in other sections of part 484, subpart E.
     Revising the section heading of Sec.  484.215 from 
``Initial establishment of the calculation of the national 60-day 
episode payment'' to ``Initial establishment of the calculation of the 
national, standardized prospective 60-day episode payment and 30-day 
payment rates.'' Also, we are adding paragraph (f) to this section to 
describe when the national, standardized prospective 30-day payment 
rate applies.
     Revising the section heading of Sec.  484.220 from 
``Calculation of the adjusted national prospective 60-day episode 
payment rate for case-mix and area wage levels'' to ``Calculation of 
the case-mix and wage area adjusted prospective payment rates.'' We are 
removing the reference to ``national 60-day episode payment rate'' and 
replacing it with ``national, standardized prospective payment''.
     Revising the section heading in Sec.  484.225 from 
``Annual update of the unadjusted national prospective 60-day

[[Page 56522]]

episode payment rate'' to ``Annual update of the unadjusted national, 
standardized prospective 60-day episode and 30-day payment rates''. 
Also, we are revising Sec.  484.225 to remove references to ``60-day 
episode'' and to refer more generally to the ``national, standardized 
prospective payment''. In addition, we are adding paragraph (d) to 
describe the annual update for CY 2020 and subsequent calendar years.
     Revising the section heading of Sec.  484.230 from 
``Methodology used for the calculation of low-utilization payment 
adjustment'' to ``Low utilization payment adjustment''. Also, we are 
designating the current text to paragraph (a) and inserting language 
such that paragraph (a) applies to claims beginning on or before 
December 31, 2019, using the current payment system. We are adding 
paragraph (b) to describe how low utilization payment adjustments are 
determined for claims beginning on or after January 1, 2020, using the 
PDGM.
     Revising the section heading of Sec.  484.235 from 
``Methodology used for the calculation of partial episode payment 
adjustments'' to ``Partial payment adjustments''. We are removing 
paragraphs (a), (b), and (c). We are removing paragraphs (1), (2), and 
(3) which describe partial payment adjustments from paragraph (d) in 
Sec.  484.205 and incorporating them into Sec.  484.235. We are adding 
paragraph (a) to describe partial payment adjustments under the current 
system, that is, for claims beginning on or before December 31, 2019, 
and paragraph (b) to describe partial payment adjustments under the 
PDGM, that is, for claims beginning on or after January 1, 2020.
     Revising the section heading for Sec.  484.240 from 
``Methodology used for the calculation of the outlier payment'' to 
``Outlier payments.'' In addition, we are removing language at 
paragraph (b) and appending it to paragraph (a). We are adding language 
to revised paragraph (a) such that paragraph (a) will apply to payments 
under the current system, that is, for claims beginning on or before 
December 31, 2019. We are revising paragraph (b) to describe payments 
under the PDGM, that is, for claims beginning on or after January 1, 
2020. In paragraph (c), we are replacing the ``estimated'' cost with 
``imputed'' cost. Lastly, we are revising paragraph (d) to reflect the 
per-15 minute unit approach to imputing the cost for each claim.
    We did not receive any comments on the corresponding regulations 
text changes regarding the PDGM; therefore, we are finalizing 
regulations text changes as proposed without modification.

G. Changes Regarding Certifying and Recertifying Patient Eligibility 
for Medicare Home Health Services

1. Regulations Text Changes Regarding Information Used To Satisfy 
Documentation of Medicare Eligibility for Home Health Services
    Section 51002 of the BBA of 2018 amended sections 1814(a) and 
1835(a) of the Act to provide that, effective for physician 
certifications and recertifications made on or after January 1, 2019, 
in addition to using the documentation in the medical record of the 
certifying physician or of the acute or post-acute care facility (where 
home health services were furnished to an individual who was directly 
admitted to the HHA from such facility), the Secretary may use 
documentation in the medical record of the HHA as supporting material, 
as appropriate to the case involved. We believe the BBA of 2018 
provisions are consistent with our existing policy in this area, which 
is currently reflected in sub-regulatory guidance in the Medicare 
Benefit Policy Manual (Pub. 100-02, chapter 7, section 30.5.1.2),\31\ 
and the Medicare Program Integrity Manual (Pub. 100-08, chapter 6 
section 6.2.3).\32\ The subregulatory guidance describes the 
circumstances in which HHA documentation can be used along with the 
certifying physician and/or acute/post-acute care facility medical 
record to support the patient's homebound status and skilled need. 
Specifically, we state that information from the HHA, such as the plan 
of care required in accordance with Sec.  409.43, and/or the initial 
and/or comprehensive assessment of the patient required in accordance 
with Sec.  484.55, can be incorporated into the certifying physician's 
medical record for the patient and used to support the patient's 
homebound status and need for skilled care.
---------------------------------------------------------------------------

    \31\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c07.pdf.
    \32\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c06.pdf.
---------------------------------------------------------------------------

    In the CY 2019 HH PPS proposed rule, we proposed to amend the 
regulations text at Sec.  424.22(c) to align the regulations text with 
current sub-regulatory guidance that allows medical record 
documentation from the HHA to be used to support the basis for 
certification and/or recertification of home health eligibility, if the 
following requirements are met:
     The documentation from the HHA can be corroborated by 
other medical record entries in the certifying physician's and/or the 
acute/post-acute care facility's medical record for the patient, 
thereby creating a clinically consistent picture that the patient is 
eligible for Medicare home health services as specified in Sec.  
424.22(a)(1) and (b).
     The certifying physician signs and dates the HHA 
documentation demonstrating that the documentation from the HHA was 
considered when certifying patient eligibility for Medicare home health 
services. HHA documentation can include, but is not limited to, the 
patient's plan of care required in accordance with Sec.  409.43 and/or 
the initial and/or comprehensive assessment of the patient required in 
accordance with Sec.  484.55.
    HHAs have the discretion to determine the type and format of any 
documentation used to support home health eligibility. Anecdotally, we 
have received reports from HHAs that they typically include this 
supporting information on the plan of care. In accordance with Sec.  
409.43(c)(3), the plan of care must be signed by the physician before 
the HHA submits its final claim for payment. In the CY 2019 HH PPS 
proposed rule, we stated that because existing sub-regulatory guidance 
allows HHA-generated documentation to be used as supporting material 
for the physician's determination of eligibility for home health 
services, we expect that most HHAs already have a process in place to 
provide this information to the certifying physician or the acute/post-
acute care facility. We solicited comments on the proposal to amend the 
regulations at Sec.  424.22(c) to align the regulations text with 
current sub-regulatory guidance to allow medical record documentation 
from the HHA to be used to support the basis for certification and/or 
recertification of home health eligibility under certain conditions and 
the comments received are summarized in this final rule with comment 
period.
    Comment: Overall, commenters were supportive of incorporating 
existing sub-regulatory guidance into regulations text as it provides 
them with reassurance that HHA-generated documentation can play an 
important role in confirming eligibility for Medicare home health 
services.
    Response: We appreciate commenter support about aligning 
regulations text with existing regulatory guidance. The goal of this 
proposal is to be flexible to allow HHA-generated documentation to 
support eligibility for home health services given that the home health

[[Page 56523]]

CoPs at Sec.  484.55 require that the HHA must verify the patient's 
eligibility for the Medicare home health benefit, including homebound 
status, both at the time of the initial assessment visit and at the 
time of the comprehensive assessment. We agree that this proposal 
incorporates existing subregulatory flexibilities into the regulations 
text that allow HHA medical record documentation to support the basis 
of home health eligibility. By incorporating the existing sub-
regulatory guidance into regulation, HHAs are assured that HHA-
generated documentation can be used as supporting material for the 
basis of home health eligibility, as long as all conditions are met. 
However, we remind commenters that the certifying physician's and/or 
the acute/post-acute care facility's medical record (if the patient was 
directly admitted to home health from such setting) for the patient 
must contain sufficient documentation of the patient's medical 
condition(s) to substantiate eligibility for home health services. The 
information may include, but is not limited to, such factors as the 
patient's diagnosis, duration of the patient's condition, clinical 
course (worsening or improvement), prognosis, nature and extent of 
functional limitations, other therapeutic interventions and results, 
etc. The certifying physician's and/or the acute/post-acute care 
facility's medical records can always stand alone in substantiating 
eligibility for home health services. Similarly, the certifying 
physician's/acute/post-acute care facility's medical record, in 
conjunction with appropriately incorporated HHA documentation (for 
example, plan of care, OASIS, etc.), may also substantiate the 
patient's eligibility for home health services. However, HHA-generated 
medical record documentation for the patient, by itself, is not 
sufficient in demonstrating the patient's eligibility for Medicare home 
health services. As noted earlier, in accordance with Sec.  424.22(a) 
and (c), it is the patient's medical record held by the certifying 
physician and/or the acute/post-acute care facility that must support 
the patient's eligibility for home health services. Therefore, any 
documentation used to support certification that was generated by the 
HHA must be signed off by the certifying physician and incorporated 
into his/her medical record. The information provided to the certifying 
physician by the HHA and incorporated into the patient's medical record 
must be corroborated by the rest of the patient's medical record. This 
means that the HHA information, along with the certifying physician's 
and/or the acute/post-acute care facility's medical record, creates a 
clinically consistent picture that the patient is eligible for Medicare 
home health services. This could include, but is not limited to, the 
plan of care required in accordance with Sec.  409.43, the initial and/
or the comprehensive assessment of the patient required in accordance 
with Sec.  484.55, the inpatient discharge summary, or multi-
disciplinary clinical notes, etc., which must correspond to the dates 
of service being billed and not contradict the certifying physician's 
and/or the acute/post-acute care facility's own documentation or 
medical record entries. Once incorporated into the certifying 
physician's medical record for the patient, the HHA information can be 
used to support the patient's homebound status and need for skilled 
care.
    Comment: A commenter expressed concern that this proposal would 
allow HHAs to have too much control over Medicare coverage decisions 
and provides an opportunity for the HHA to override the physician's 
opinion. This commenter went on to state that there may be a 
physician's order for care that subsequently has been reduced or 
discontinued by the HHA and that beneficiaries are forced to settle for 
less care for fear that the HHA will not provide any services at all. 
This same commenter stated that certifying physicians are busy and do 
not have the time to read hundreds of detailed home health agency 
records. This commenter recommended that the HHA-generated 
documentation should be used only to confirm eligibility and not to 
deny coverage for patients that home health agencies no longer want to 
serve.
    Response: We note that coverage of Medicare home health services is 
dependent upon beneficiary eligibility for Medicare home health 
services as set forth at Sec.  409.42. We remind commenters that the 
HHA-generated documentation may only be used to support the certifying 
physician and/or the acute/post-acute care facility's medical record 
documentation for eligibility for Medicare home health services. As 
such, the HHA-generated documentation is not meant to supersede, 
override or negate the physician's opinion or any physician orders in 
the established home health plan of care. The HHA-generated 
documentation is only meant to augment, as necessary, the certifying 
physician's and/or acute/post-acute care facility's medical 
documentation to create a clinically consistent picture that the 
patient is eligible for home health services. Any HHA-generated 
information provided to the certifying physician by the HHA and 
incorporated into the patient's medical record held by the certifying 
physician and/or the acute/post-acute care facility's medical record 
(if the patient was directly admitted to home health for such setting) 
must be corroborated by the rest of the patient's medical record. As 
such, we do not expect that HHAs would need to send voluminous clinical 
records to a certifying physician for his/her review when certifying a 
patient for home health eligibility as the certifying physician's and/
or the acute/post-acute care facility's medical records are required to 
have sufficient information to serve as the basis for home health 
eligibility. Additionally, the certifying physician is responsible for 
establishing and periodically reviewing the home health plan of care in 
accordance with the home health CoPs at 42 CFR 484.60(a)(1). While the 
HHA is responsible for coordinating with the certifying physician 
regarding any revisions to the home health plan of care, drugs, 
services, and treatments are administered only as ordered by a 
physician. Therefore, it would be a violation of the home health CoPs 
for a HHA to revise the plan of care, including reducing or 
discontinuing any items or services identified on the plan of care, 
without specific orders from the certifying physician. Finally, the 
purpose of the supporting documentation is to confirm eligibility for 
Medicare home health services. However, if the certifying physician's 
and/or acute/post-acute care facility's documentation and the HHA-
generated incorporated supporting documentation do not create a 
clinically consistent picture that the individual is eligible for 
Medicare home health services (for example, the individual is homebound 
and requires skilled services), this would not meet the requirements 
for coverage.
    Comment: Another commenter asked if the certifying physician is 
required to sign every page of HHA-generated supporting documentation 
to demonstrate that the documentation from the HHA was considered when 
certifying patient eligibility for Medicare home health services.
    Response: There are no specific regulations regarding physician 
signature on a document with multiple pages. In accordance with Sec.  
484.110(b) of our regulations, all patient medical record entries must 
be legible, complete, dated, timed, and authenticated in written or 
electronic form by the person responsible for providing or evaluating 
the service provided. Only when it is clear that an individual document

[[Page 56524]]

extends to multiple pages (for example, a notation on a multi-page 
document that identifies pagination--``page 2 of 4''), and that the 
entire document is then authenticated, would a signature on a single 
page suffice for other pages as well.\33\ However, we recognize that 
there may be multiple variations in the way HHA documentation is 
incorporated into the certifying physician's and/or acute/post-acute 
care facility's medical records. As such, we will provide future sub-
regulatory guidance to address any identified variations. We believe 
this will provide additional clarity for HHAs and decrease the 
likelihood that inconsistent decisions would be made by appeals 
adjudicators regarding certification of patient eligibility for home 
health services.
---------------------------------------------------------------------------

    \33\ See, https://med.noridianmedicare.com/web/jfb/cert-reviews/signature-requirement-q-a.
---------------------------------------------------------------------------

    Comment: A commenter suggested that CMS should clarify that the 
patient's plan of care, with sufficient information to support 
eligibility and signed by the certifying physician, may be used as 
documentation from the physician's medical record to support 
eligibility for home health services. This commenter stated that CMS 
might consider revising the regulatory text at 42 CFR 424.22(c) to 
read:

``. . . . documentation can include, but is not limited to, the 
patient's plan of care and/or the initial or the comprehensive 
assessment''.
    Response: We agree with this commenter's suggestion given we stated 
in the preamble of the CY 2019 HH PPS proposed rule that information 
from the HHA, such as the plan of care required in accordance with 
Sec.  409.43 and/or the initial and/or comprehensive assessment of the 
patient required in accordance with Sec.  484.55, can be incorporated 
into the certifying physician's medical record for the patient and used 
to support the patient's homebound status and need for skilled care. We 
also agree the patient's plan of care could be the sole HHA 
documentation that is incorporated into the certifying physician's and/
or the acute/post-acute care facility's medical record for the patient 
and used to support the basis for certification of home health 
eligibility if the plan of care provides sufficient information to 
support eligibility. We remind commenters that the CoPs at Sec.  484.60 
provide the content requirements for the plan of care including all 
pertinent diagnoses and functional limitations. Likewise, we remind 
commenters that the certifying physician's and/or the acute/post-acute 
care facility's medical documentation shall be used as the basis for 
home health eligibility. The documentation from the HHA serves only as 
supporting documentation for the purposes of certification if 
incorporated into the certifying physician's and/or the acute/post-
acute care facility's medical record for the patient. We will revise 
the regulatory text at Sec.  424.22(c) accordingly to reflect 
commenters' concerns.
    Final Decision: We are finalizing the proposal to amend the 
regulations text at Sec.  424.22(c) to align with current subregulatory 
guidance to allow medical record documentation from the HHA to be used 
to support the basis for certification and/or recertification of home 
health eligibility, if the certain requirements are met as previously 
described.
2. Elimination of Recertification Requirement To Estimate How Much 
Longer Home Health Services Will Be Required
    In the CY 2018 HH PPS proposed rule (82 FR 35378), we invited 
public comments about improvements that can be made to the health care 
delivery system that reduce unnecessary burdens for clinicians, other 
providers, and patients and their families. Specifically, we asked the 
public to submit their ideas for regulatory, sub-regulatory, policy, 
practice, and procedural changes to reduce burdens for hospitals, 
physicians, and patients, improve the quality of care, decrease costs, 
and ensure that patients and their providers and physicians are making 
the best health care choices possible.
    Several commenters requested that CMS consider eliminating the 
requirement that the certifying physician include an estimate of how 
much longer skilled services will be required at each home health 
recertification, as set forth at Sec.  424.22(b)(2) and in sub- 
regulatory guidance in the Medicare Benefit Policy Manual (Chapter 7, 
Section 30.5.2). Commenters stated that this estimate is duplicative of 
the Home Health CoP requirements for the content of the home health 
plan of care, set out at Sec.  484.60(a)(2).
    We determined that the estimate of how much longer skilled care 
will be required at each recertification is not currently used for 
quality, payment, or program integrity purposes. Given this 
consideration and the existing home health CoP requirements for the 
content of the home health plan of care, in the CY 2019 HH PPS proposed 
rule we proposed to eliminate the regulatory requirement, as set forth 
at Sec.  424.22(b)(2), that the certifying physician, as part of the 
recertification statement, provide an estimate of how much longer 
skilled services will be required (83 FR 32424). All other 
recertification content requirements under Sec.  424.22(b)(2) would 
remain unchanged. We noted that the elimination of this recertification 
requirement would result in a reduction of burden for certifying 
physicians by reducing the amount of time physicians spend on the 
recertification process, resulting in an overall cost savings of $14.2 
million. We provide a description of this burden reduction in section 
X.C.1.c. of this final rule with comment period.
    We solicited comments regarding the proposed elimination of the 
requirement that the certifying physician include an estimate of how 
much longer skilled services will be required at each home health 
recertification, as well as the corresponding regulations text changes 
at Sec.  424.22(b)(2).
    Comment: Commenters overwhelmingly supported this proposal. 
Commenters stated that the elimination of this requirement would help 
to streamline documentation and make it easier for agencies to obtain 
necessary information from supervising physicians in a timely manner. 
Commenters also remarked that removing this requirement will also be 
consistent with the ``Patients over Paperwork'' initiative. Other 
commenters remarked that this would allow certifying physicians to 
focus more time on patient care.
    Response: We appreciate commenter support on this proposal and we 
agree that elimination of this recertification requirement would reduce 
the amount of time certifying physicians would spend reviewing medical 
documentation. This change would reduce the time spent by physicians 
for recertification without diminishing existing documentation 
requirements and will allow greater emphasis to be placed on patient 
care.
    Final Decision: Effective for recertifications made on and after 
January 1, 2019, we are finalizing our proposal to eliminate the 
regulatory requirement set forth at Sec.  424.22(b)(2) that requires 
the certifying physician, as part of the recertification process, to 
provide an estimate of how much longer skilled services will be 
required. All other recertification content requirements under Sec.  
424.22(b)(2) would remain unchanged.

[[Page 56525]]

H. Change Regarding Remote Patient Monitoring Under the Medicare Home 
Health Benefit
    In the CY 2019 HH PPS proposed rule (83 FR 32425), we acknowledged 
the potential benefit of the use of remote patient monitoring to 
augment the home health plan of care. We discussed how remote patient 
monitoring could enable the HHA to more quickly identify any changes in 
the patient's clinical condition, prompting physician review of, and 
potential changes to, the plan of care. For example, in cases where the 
home health patient is admitted for skilled observation and assessment 
of the patient's condition due to a reasonable potential for 
complications or an acute episode, remote patient monitoring could 
augment home health visits until the patient's clinical condition 
stabilized. Fluctuating or abnormal vital signs could be monitored 
between visits, potentially leading to quicker interventions and 
updates to the treatment plan. Additionally, we discussed findings of 
our literature review that revealed that remote patient monitoring may 
improve patients' ability to maintain independence, improving their 
quality of life. Particularly for patients with chronic obstructive 
pulmonary disease (COPD) and congestive heart failure (CHF), research 
indicates that remote patient monitoring has been successful in 
reducing readmissions and long-term acute care utilization.\34\ Other 
benefits included fewer complications and decreased costs.
---------------------------------------------------------------------------

    \34\ Broad, J., Davis, C., Bender, M., Smith, T. (2014) 
Feasibility and Acute Care Utilization Outcomes of a Post-Acute 
Transitional Telemonitoring Program for Underserved Chronic Disease 
Patients. Journal of Cardiac Failure. Vol 20 (8S) S116. http://dx.doi.org/10.1016/j.cardfail.2014.06.328.
---------------------------------------------------------------------------

    We explained that although section 1895(e)(1)(A) of the Act 
prohibits payment for services furnished via a telecommunications 
system if such services substitute for in-person home health services 
ordered as part of a plan of care, the statute does not define the term 
``telecommunications system'' as it relates to the provision of home 
health care. While a service using a form of telecommunications, remote 
patient monitoring is not considered a Medicare telehealth service as 
defined under section 1834(m) of the Act. Additionally, there is no 
direct interaction between the patient and the practitioner. Remote 
monitoring, rather uses digital technology to relay information 
captured by the patient to the practitioner for review, and to 
potentially prompt changes to the plan of care. We explained that for 
these reasons it would not be subject to the telehealth restrictions on 
originating site and interactive telecommunications systems technology 
under section 1834(m) of the Act.
    Therefore, because the statute does not define the term 
``telecommunications system'' as it relates to the provision of home 
health care, we proposed to define remote patient monitoring in 
regulation under the Medicare home health benefit as ``the collection 
of physiologic data (for example, ECG, blood pressure, glucose 
monitoring) digitally stored and/or transmitted by the patient and/or 
caregiver to the HHA.'' This definition aligns with the description for 
CPT code 99091, which allows physicians and other healthcare 
professionals to bill for the collection and interpretation of 
physiologic data digitally stored and/or transmitted by the patient 
and/or caregiver to the physician or other qualified health care 
professional (82 CFR 53013). We recognized that HHAs cannot bill for 
this code (CPT code 99091); however, we believe the code's description 
accurately describes remote monitoring services. We also noted that CPT 
code 99091 includes the interpretation of the physiologic data, whereas 
the HHA would only be responsible for the collection of the data.
    Currently home health costs associated with remote patient 
monitoring are reported on line 23.20 on Worksheet A as direct costs 
associated with telemedicine. For 2016, approximately 3 percent of HHAs 
reported telemedicine costs that accounted for roughly 1 percent of 
their total agency costs on the HHA cost report. However, these costs 
are not allocated to the costs per visit. Allowing HHAs to report the 
costs of remote patient monitoring on the HHA cost report as part of 
their operating expenses, which are factored into the costs per visit, 
would have important implications for assessing home health costs 
relevant to payment, including HHA Medicare margin calculations. 
Therefore, we proposed to amend the regulations at 42 CFR 409.46 to 
include the costs of remote patient monitoring as an allowable 
administrative cost (that is, operating expense), if remote patient 
monitoring is used by the HHA to augment the care planning process.
    We solicited comments on the proposed regulatory definition of 
remote patient monitoring under the HH PPS to describe 
telecommunication services used to augment the plan of care during a 
home health episode. Additionally, we welcomed comments regarding 
additional utilization of telecommunications technologies for 
consideration in future rulemaking. We also solicited comments on the 
proposed changes to the regulations at 42 CFR 409.46, to include the 
costs of remote patient monitoring as allowable administrative costs 
(that is, operating expenses) on the HHA cost report. The following is 
a summary of the public comments received and our responses.
    Comment: Comments regarding the proposal to define remote patient 
monitoring in regulation for the Medicare home health benefit and to 
include the costs of remote patient monitoring as an allowable expense 
on the HHA cost report were overwhelmingly positive. Commenters stated 
that there are multiple benefits to integrating the costs of remote 
patient monitoring into home health, including providing clinicians 
with real-time updates on patient condition and providing patients with 
timely feedback, thereby encouraging patient engagement. Additionally, 
commenters stated that it allows for greater involvement with nurses 
and physicians, while decreasing travel, which may be advantageous not 
only in rural areas, but urban areas as well.
    Response: We thank commenters for their positive feedback regarding 
these proposals. We agree that there are many benefits to remote 
patient monitoring and anticipate that defining it in regulation and 
allowing for more clear analysis of the associated costs through the 
cost report will encourage its use in home health and have a positive 
effect on patient outcomes.
    Comment: Several commenters encouraged CMS to monitor utilization 
patterns to ensure that remote patient monitoring is not being used as 
a substitute for face-to-face visits. A commenter suggested that CMS 
require information about the frequency and duration of the use of 
remote patient monitoring services; specifically, that the HHA be 
required to report on the Medicare claim whether an episode included 
the use of remote patient monitoring.
    Response: We agree with the recommendation to monitor utilization 
patterns to ensure appropriate use of the service under the home health 
benefit. We also agree that data concerning whether individuals 
received remote patient monitoring during the 30-day period of care 
could be informative. We will consider ways to obtain this information 
in the future.
    Comment: Another commenter suggested that CMS clarify that if the 
remote monitoring service is a nursing service, it can help satisfy the 
skilled nursing requirement to trigger Medicare

[[Page 56526]]

coverage for other covered home health services such as home health 
aides and occupational therapy.
    Response: In accordance with section 1861(m) of the Act, home 
health services must be furnished in the beneficiary's home. 
Additionally, Sec.  409.48 defines a visit as an episode of personal 
contact with the beneficiary by staff of the HHA or others under 
arrangements with the HHA, for the purpose of providing a covered 
service. Finally, section 1895(e)(1)(B) of the Act states that services 
furnished via a telecommunications systems are not considered home 
health visits for purposes of eligibility or payment. Therefore, we do 
not consider the use of remote patient monitoring alone and/or a visit 
solely for the purpose of setting up and/or training the patient on 
remote monitoring equipment to meet the criteria for prompting coverage 
of home health services under the Medicare home health benefit.
    Comment: Several commenters suggested adding the descriptions of 
two new proposed Physician Fee Schedule CPT codes: CPT codes 990X0, 
set-up and patient education on use of equipment and 990X1, device 
supply with daily recordings or programmed alerts transmission, to the 
proposed home health definition in order to allow for a more 
appropriate and complete description of allowable costs for remote 
patient monitoring services in the home health setting. Commenters 
suggested this would also help to establish consistency regarding 
remote patient monitoring across Medicare sites of service.
    Response: We recognize that the descriptors for these two codes 
allows for greater specificity of the process of remote patient 
monitoring, which in turn would lead to more accurate analysis of the 
associated costs. While the proposed home health regulations text at 
Sec.  409.46(e) would permit the cost and service of the equipment to 
be allowable administrative costs, we agree that set-up and patient 
education should be allowable expenses reported on the cost report. 
However, we wish to clarify that a visit to set up and/or train the 
patient on the equipment would not be allowed on the HHA claim when no 
other skilled service is provided. In other words, a visit cannot be 
reported when the sole reason is to set up and/or train the patient on 
the use of the remote monitoring equipment. Therefore, we are adding 
language to the regulations text to ensure a more complete description 
of remote patient monitoring services, with the qualification that such 
set-up and patient education services cannot be reported as a visit 
without the provision of another skilled service.
    Comment: A commenter recommended that CMS describe how it plans to 
account for the adoption of new remote patient monitoring services as 
the agency monitors and evaluates the impact of previous or future 
rebasing adjustments made to the home health prospective payment rates 
since 2014. Another commenter stated that in order to implement in an 
effective and consistent manner, CMS needs to develop an appropriate 
corresponding payment methodology. Other commenters suggested CMS set 
up a demonstration project where HHAs have an incentive to make an 
investment in technologies, or incorporate telehealth waivers into all 
demonstration projects. Other commenters stated that CMS should have a 
more broad approach to telehealth and telemedicine to include virtual 
visits as a potential strategy to address workforce challenges. Others 
stated CMS should directly reimburse for remote patient monitoring, 
perhaps as a non-routine supply for agencies who are actually providing 
the service, as the proposal will indirectly provide increased 
reimbursement for all agencies, not specifically for those providing 
the service.
    Response: We appreciate the commenters' suggestions. While we 
understand that these comments indicate that some commenters would like 
to see additional activities in incentivizing the use of remote patient 
monitoring in home health, we believe that allowing the costs 
associated with remote patient monitoring to be reported on the cost 
report is a necessary first step in determining the cost and frequency 
in which HHAs are currently utilizing this technology and whether the 
use of such technology improves health outcomes for home health 
patients. Additionally, we reiterate that section 1895(e)(1)(A) of the 
Act prohibits payment for services furnished via a telecommunications 
system if such services substitute for in-person home health services 
ordered as part of a plan of care certified by a physician. Thus 
virtual home health visits would not qualify for payment under the home 
health benefit. We plan to closely monitor remote patient monitoring 
costs and the impact that such technology may have on patient outcomes 
under the traditional Medicare home health benefit and we will consider 
ways to more broadly support such technology as part of home health.
    Comment: A commenter suggested that rather than allowing the costs 
of remote patient monitoring to be included on the home health cost 
report, remote patient monitoring should be excluded from the home 
health episode and provided as a distinct and separately reimbursed 
service. The commenter stated that this would recognize the value of 
remote patient monitoring services while also recognizing home health 
agencies as providers of these services. Home health agencies would 
then be able to provide these services to patients within home health 
but also to those who do not qualify for home health but would benefit 
from RPM services, despite not having a mechanism for reimbursement. 
Similarly, another commenter suggested that a telehealth chronic care 
management program conceptualized as a ``step down'' program from an 
episode of care would benefit many patients greatly and may serve as an 
alternative to successive full episodes of care.
    Response: We thank the commenters for these suggestions; however, 
we believe that these comments suggest the implementation of a separate 
remote patient monitoring benefit under Medicare and are therefore 
outside of the scope of this rule. Additionally, we note that beginning 
in CY 2018, separate payment is made under the Physician Fee Schedule 
for CPT code 99091 (Collection and interpretation of physiologic data 
(for example., ECG, blood pressure, glucose monitoring) digitally 
stored and/or transmitted by the patient and/or caregiver to the 
physician or other qualified health care professional). This code, 
billed directly by a practitioner, allow remote patient monitoring to 
be provided outside of the home health benefit for non-homebound 
patients.
    Comment: Several commenters requested that CMS clarify whether the 
agency intends that all qualified health professionals, specifically 
physical therapists, speech language pathologists, and occupational 
therapists, acting within their scope of practice, may use remote 
patient monitoring to augment the plan of care during a home health 
episode.
    Response: Our definition does not specify which skilled 
professionals may utilize remote patient monitoring under home health. 
As therapy goals must be established by a qualified therapist in 
conjunction with the physician when determining the plan of care, we 
believe therapists involved in care planning, as well as other skilled 
professionals acting within their scope of practice, may utilize remote 
patient monitoring to augment this process.
    Final decision: We are finalizing our proposal to define remote 
patient

[[Page 56527]]

monitoring under the Medicare home health benefit as ``the collection 
of physiologic data (for example, ECG, blood pressure, glucose 
monitoring) digitally stored and/or transmitted by the patient or 
caregiver or both to the home health agency.'' We are adding the 
following language to the regulations text to ensure a more complete 
description of remote patient monitoring services, while also ensuring 
that such services cannot be reported as a visit without the provision 
of another skilled service: Visits to a beneficiary's home for the sole 
purpose of supplying, connecting, and/or training the patient on the 
remote patient monitoring equipment, without the provision of another 
skilled service are not separately billable. These services do 
constitute services included in the expense of providing remote patient 
monitoring allowed as administrative costs.
    Additionally, we are finalizing our proposal to amend the 
regulations at 42 CFR 409.46 to include the costs of remote patient 
monitoring as an allowable administrative cost (that is, operating 
expense), if remote patient monitoring is used by the HHA to augment 
the care planning process.

IV. Home Health Value-Based Purchasing (HHVBP) Model

A. Background

    As authorized by section 1115A of the Act and finalized in the CY 
2016 HH PPS final rule (80 FR 68624), we began testing the HHVBP Model 
on January 1, 2016. The HHVBP Model has an overall purpose of improving 
the quality and delivery of home health care services to Medicare 
beneficiaries. The specific goals of the Model are to: (1) Provide 
incentives for better quality care with greater efficiency; (2) study 
new potential quality and efficiency measures for appropriateness in 
the home health setting; and (3) enhance the current public reporting 
process.
    Using the randomized selection methodology finalized in the CY 2016 
HH PPS final rule, we selected nine states for inclusion in the HHVBP 
Model, representing each geographic area across the nation. All 
Medicare-certified Home Health Agencies (HHAs) providing services in 
Arizona, Florida, Iowa, Maryland, Massachusetts, Nebraska, North 
Carolina, Tennessee, and Washington (competing HHAs) are required to 
compete in the Model. Requiring all Medicare-certified HHAs providing 
services in the selected states to participate in the Model ensures 
that: (1) There is no selection bias; (2) participating HHAs are 
representative of HHAs nationally; and (3) there is sufficient 
participation to generate meaningful results.
    As finalized in the CY 2016 HH PPS final rule, 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 beginning in CY 
2018 based on the competing HHAs' performance on applicable measures. 
Payment adjustments will be increased incrementally over the course of 
the HHVBP Model in the following manner: (1) A maximum payment 
adjustment of 3 percent (upward or downward) in CY 2018; (2) a maximum 
payment adjustment of 5 percent (upward or downward) in CY 2019; (3) a 
maximum payment adjustment of 6 percent (upward or downward) in CY 
2020; (4) a maximum payment adjustment of 7 percent (upward or 
downward) in CY 2021; and (5) a maximum payment adjustment of 8 percent 
(upward or downward) in CY 2022. Payment adjustments are based on each 
HHA's Total Performance Score (TPS) in a given performance year (PY) 
comprised of: (1) A set of measures already reported via the Outcome 
and Assessment Information Set (OASIS) and completed Home Health 
Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) 
surveys for all patients serviced by the HHA and select claims data 
elements; and (2) three New Measures for which points are achieved for 
reporting data.
    For CY 2019 (83 FR 32426), we proposed to remove five measures and 
add two new proposed composite measures to the applicable measure set 
for the HHVBP model, revise our weighting methodology for the measures, 
and rescore the maximum number of improvement points.

B. Quality Measures

1. Removal of Two OASIS-Based Measures Beginning With Performance Year 
4 (CY 2019)
    In the CY 2016 HH PPS final rule, we finalized a set of quality 
measures in Figure 4a: Final PY1 Measures and Figure 4b: Final PY1 New 
Measures (80 FR 68671 through 68673) for the HHVBP Model to be used in 
PY1, referred to as the starter set. We also stated that this set of 
measures will be subject to change or retirement during subsequent 
model years and revised through the rulemaking process (80 FR 68669).
    The measures were selected for the Model using the following 
guiding principles: (1) Use a broad measure set that captures the 
complexity of the services HHAs provide; (2) incorporate flexibility 
for future inclusion of the Improving Medicare Post-Acute Care 
Transformation Act of 2014 (IMPACT) measures that cut across post-acute 
care settings; (3) develop `second generation' (of the HHVBP Model) 
measures of patient outcomes, health and functional status, shared 
decision making, and patient activation; (4) include a balance of 
process, outcome and patient experience measures; (5) advance the 
ability to measure cost and value; (6) add measures for appropriateness 
or overuse; and (7) promote infrastructure investments. This set of 
quality measures encompasses the multiple National Quality Strategy 
(NQS) domains \35\ (80 FR 68668). The NQS domains include six priority 
areas identified in the CY 2016 HH PPS final rule (80 FR 68668) as the 
CMS Framework for Quality Measurement Mapping. These areas are: (1) 
Clinical quality of care; (2) Care coordination; (3) Population & 
community health; (4) Person- and Caregiver-centered experience and 
outcomes; (5) Safety; and (6) Efficiency and cost reduction. Figures 4a 
and 4b of the CY 2016 HH PPS final rule identified 15 outcome measures 
(five from the HHCAHPS, eight from OASIS, and two claims-based 
measures), and nine process measures (six from OASIS, and three New 
Measures, which were not previously reported in the home health 
setting) for use in the Model.
---------------------------------------------------------------------------

    \35\ 2015 Annual Report to Congress, http://www.ahrq.gov/workingforquality/reports/annual-reports/nqs2015annlrpt.htm.
---------------------------------------------------------------------------

    In the CY 2017 HH PPS final rule, we removed four measures from the 
measure set for PY1 and subsequent performance years: (1) Care 
Management: Types and Sources of Assistance; (2) Prior Functioning ADL/
IADL; (3) Influenza Vaccine Data Collection Period: Does this episode 
of care include any dates on or between October 1 and March 31?; and 
(4) Reason Pneumococcal Vaccine Not Received, for the reasons discussed 
in that final rule (81 FR 76743 through 76747).
    In the CY 2018 HH PPS final rule, we removed the OASIS-based 
measure, Drug Education on All Medications Provided to Patient/
Caregiver during All Episodes of Care, from the set of applicable 
measures beginning with PY3 for the reasons discussed in that final 
rule (82 FR 51703 through 51704).
    For PY4 and subsequent performance years, we proposed (83 FR 32426 
through 32427) to remove two OASIS-based process measures, Influenza 
Immunization Received for Current Flu

[[Page 56528]]

Season and Pneumococcal Polysaccharide Vaccine Ever Received, from the 
set of applicable measures. We adopted the Influenza Immunization 
Received for Current Flu Season measure beginning PY1 of the model. 
Since that time, we have received input from both stakeholders and a 
Technical Expert Panel (TEP) convened by our contractor in 2017 that 
because the measure does not exclude HHA patients who were offered the 
vaccine but declined it and patients who were ineligible to receive it 
due to contraindications, the measure may not fully capture HHA 
performance in the administration of the influenza vaccine. In response 
to these concerns, we proposed to remove the measure from the 
applicable measure set beginning PY4.
    We also adopted the Pneumococcal Polysaccharide Vaccine Ever 
Received measure beginning PY1 of the model. This process measure 
reports the percentage of HH episodes during which patients were 
determined to have ever received the Pneumococcal Polysaccharide 
Vaccine. The measure is based on guidelines previously issued by the 
Advisory Committee on Immunization Practices (ACIP),\36\ which 
recommended use of a single dose of the 23-valent pneumococcal 
polysaccharide vaccine (PPSV23) among all adults aged 65 years and 
older and those adults aged 19-64 years with underlying medical 
conditions that put them at greater risk for serious pneumococcal 
infection.\37\ In 2014, the ACIP updated its guidelines to recommend 
that both vaccines, the PCV13 and the PPSV23, be given to all 
immunocompetent adults aged >=65 years.\38\ The recommended intervals 
for sequential administration of PCV13 and PPSV23 depend on several 
patient factors including: The current age of the adult, whether the 
adult had previously received PPSV23, and the age of the adult at the 
time of prior PPSV23 vaccination (if applicable). Because the 
Pneumococcal Polysaccharide Vaccine Ever Received measure does not 
fully reflect the current ACIP guidelines, we proposed to remove this 
measure from the model beginning PY4.
---------------------------------------------------------------------------

    \36\ The Advisory Committee on Immunization Practices was 
established under Section 222 of the Public Health Service Act (42 
U.S.C. 217a), as amended, to assist states and their political 
subdivisions in the prevention and control of communicable diseases; 
to advise the states on matters relating to the preservation and 
improvement of the public's health; and to make grants to states 
and, in consultation with the state health authorities, to agencies 
and political subdivisions of states to assist in meeting the costs 
of communicable disease control programs. (Charter of the Advisory 
Committee on Immunization Practices, filed April 1, 2018. https://www.cdc.gov/vaccines/acip/committee/ACIP-Charter-2018.pdf).
    \37\ Prevention of Pneumococcal Disease: Recommendations of the 
Advisory Committee on Immunization Practices (ACIP), MMWR 1997;46:1-
24.
    \38\ Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent 
pneumococcal conjugate vaccine and 23-valent pneumococcal 
polysaccharide vaccine among adults aged >=65 years: recommendations 
of the Advisory Committee on Immunization Practices (ACIP). MMWR 
2014; 63: 822-5.
---------------------------------------------------------------------------

    We invited public comment on our proposal to remove these two 
OASIS-based measures, Influenza Immunization Received for Current Flu 
Season and Pneumococcal Polysaccharide Vaccine Ever Received, from the 
set of applicable measures for PY4 and subsequent performance years.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: The majority of commenters supported removing both OASIS-
based process measures, Influenza Immunization Received for Current Flu 
Season and Pneumococcal Polysaccharide Vaccine Ever Received, citing 
concerns that process measures may be burdensome on providers to report 
while yielding limited information to support clinical improvement. 
Commenters also noted that removal of the measures aligns with the 
Meaningful Measure Initiative. Several commenters opposed any changes 
to the HHVBP model's applicable measure set and recommended that CMS 
complete testing of the HHVBP model prior to making any changes. A 
commenter opposed removal of the Pneumococcal Polysaccharide Vaccine 
Ever Received measure, stating that removal may lead to reductions in 
pneumococcal immunization rates. The commenter believes that CMS should 
retain this measure until it is updated to reflect the most current 
ACIP guidelines. The commenter noted that the measure aligned with 
Meaningful Measures criteria on high-impact conditions and patient-
centered care, adding that retaining the measure would not be 
burdensome to HHAs, given their ability to establish standing orders to 
support immunization processes. Another commenter opposed removal of 
the Influenza Immunization Received for Current Flu Season measure as 
the commenter believes that it is an important safety measure that may 
be overlooked if it is no longer required to be reported.
    Response: With regard to those comments that opposed changes to the 
HHVBP Model's applicable measure set until testing of the Model has 
concluded, we reiterate that one of the goals of the Model is to study 
new potential quality and efficiency measures for appropriateness in 
the home health setting. We indicated in the CY 2016 HH PPS final rule 
that the initial set of measures adopted for use in the Model would be 
subject to change during subsequent model years and, as summarized 
previously and in the proposed rule, we have finalized the removal of 
other measures included in the initial measure set in prior rulemaking. 
We continue to believe it is important to evaluate and consider changes 
to the measure set during the course of testing the Model because the 
relevance of certain quality measures may change over time (for 
example, a measure may become ``topped out''). We also note that we 
attempt to align with other CMS reporting programs, such as the Home 
Health Quality Reporting Program (HH QRP), to the extent possible, in 
order to minimize HHAs' reporting burden, as well as to focus on 
outcome-based measures where possible and align to clinical or best 
practice.
    With respect to the commenter's concern that removal of the 
``Influenza'' measure from the HHVBP model's applicable measure set 
would result in the vaccine not being given, we note that while the 
purpose of including these measures may be to drive certain outcomes or 
processes, such as administering a vaccine, removing the measure from 
the HHVBP Model's applicable measure set does not mean that HHAs will 
avoid providing appropriate care when needed. Moreover, although the 
``Influenza'' measure was removed from the Quality of Patient Care Star 
Rating effective April 2018, HHAs will continue to report the measure 
in the HH QRP and it will continue to be displayed on Home Health 
Compare (HHC). As discussed in the proposed rule, we proposed to remove 
this measure from the HHVBP model's applicable measure set in response 
to concerns that it may not fully capture HHA performance in the 
administration of the influenza vaccine. However, we believe that HHAs 
will continue to have an incentive to provide the vaccine where 
appropriate.
    With respect to the removal of the Pneumococcal Polysaccharide 
Vaccine Ever Received measure, we note that CMS is finalizing in this 
final rule with comment period the removal of this measure for purposes 
of the HH QRP beginning with the CY 2021 HH QRP and will publicly 
report the measure on HHC until January 2021. As we discuss in response 
to comments in section V. of this final rule with comment period, while 
we understand that assessing and appropriately vaccinating patients are 
important components of the care

[[Page 56529]]

process, we also prioritize ensuring that quality measures can be used 
by practitioners to inform their clinical decision and care planning 
activities. The updated ACIP pneumococcal vaccination recommendations 
require information that is often not available to HHAs, including 
whether the patient has previously been vaccinated, the type of 
pneumococcal vaccine received by the patient, as well as the sequencing 
of vaccine administration. In addition, the physician issuing orders 
and responsible for the home health plan of care may not be the 
patient's primary care practitioner or other health care professional 
responsible for providing care and services to the patient before and 
after discharge from the agency, and therefore may not be best able to 
provide the HHA with such information. Finally, even if the 
pneumococcal vaccination status of the patient is available, OASIS 
Items M1051, Pneumococcal Vaccine and M1056, Reason Pneumococcal 
Vaccine not received that are used in the calculation of this measure 
do not correspond to the updated ACIP pneumococcal vaccination 
recommendations and therefore may not accurately measure HHA 
performance in this area. However, we understand and value the role 
pneumococcal vaccines play in preventing pneumococcal disease \39\ and 
we encourage that, whenever possible and as appropriate, HHAs provide 
pneumococcal vaccinations for their patients. As with the influenza 
vaccination measure, we do not believe that our removal of this measure 
from the HHVBP model will result in HHAs failing to provide appropriate 
care for beneficiaries.
---------------------------------------------------------------------------

    \39\ CDC: Pneumococcal Disease. Retrieved from: http://www.cdc.gov/pneumococcal/about/prevention.html.
---------------------------------------------------------------------------

    Final Decision: After considering public comments, we are 
finalizing as proposed the removal of the Influenza Immunization 
Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine 
Ever Received measures from the set of applicable measures beginning 
with PY4 and subsequent years of the model.

2. Replacement of Three OASIS-Based Measures With Two Composite 
Measures Beginning With Performance Year 4

    As previously noted, one of the goals of the HHVBP Model is to 
study new potential quality and efficiency measures for appropriateness 
in the home health setting. In the CY 2018 HH PPS Final Rule, we 
solicited comment on additional quality measures for future 
consideration in the HHVBP model, specifically a Total Change in ADL/
IADL Peformance by HHA Patients Measure, a Composite Functional Decline 
Measure, and behavioral health measures (82 FR 51706 through 51711). 
For the reasons discussed in the proposed rule (83 FR 32427 through 
32429), we proposed to replace three individual OASIS measures 
(Improvement in Bathing, Improvement in Bed Transferring, and 
Improvement in Ambulation-Locomotion) with two composite measures: 
Total Normalized Composite Change in Self-Care and Total Normalized 
Composite Change in Mobility. As we discussed in the CY 2019 HH PPS 
proposed rule, these proposed measures use several of the same ADLs as 
the composite measures discussed in the CY 2018 HH PPS final rule (82 
FR 51707). Our contractor convened a TEP in November 2017, which 
supported the use of two composite measures in place of the three 
individual measures because HHA performance on the three individual 
measures would be combined with HHA performance on six additional ADL 
measures to create a more comprehensive assessment of HHA performance 
across a broader range of patient ADL outcomes. The TEP also noted that 
HHA performance is currently measured based on any change in 
improvement in patient status, while the composite measures would 
report the magnitude of patient change (either improvement or decline) 
across six self-care and three mobility patient outcomes.
    We indicated in the proposed rule that there are currently three 
ADL improvement measures in the HHVBP Model (Improvement in Bathing, 
Improvement in Bed Transferring, and Improvement in Ambulation-
Locomotion). The maximum cumulative score across all three measures is 
30. Because we proposed to replace these three measures with the two 
composite measures, we also proposed that each of the two composite 
measures would have a maximum score of 15 points, to ensure that the 
relative weighting of ADL-based measures would stay the same. That is, 
there would still be a maximum of 30 points available for ADL-related 
measures.
    We stated that the proposed Total Normalized Composite Change in 
Self-Care and Total Normalized Composite Change in Mobility measures 
would represent a new direction in how quality of patient care is 
measured in home health. We stated that both of these proposed 
composite measures combine several existing and endorsed HH QRP outcome 
measures into focused composite measures to enhance quality reporting. 
These proposed composite measures fit within the Patient and Family 
Engagement \40\ domain as functional status and functional decline are 
important to assess for residents in home health settings. Patients who 
receive care from an HHA may have functional limitations and may be at 
risk for further decline in function because of limited mobility and 
ambulation.
---------------------------------------------------------------------------

    \40\ 2017 Measures under Consideration List. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/2017-CMS-Measurement-Priorities-and-Needs.pdf.
---------------------------------------------------------------------------

    The proposed Total Normalized Composite Change in Self-Care measure 
computes the magnitude of change, either positive or negative, based on 
a normalized amount of possible change on each of six OASIS-based 
quality outcomes. These six outcomes are as follows:

 Improvement in Grooming (M1800)
 Improvement in Upper Body Dressing (M1810)
 Improvement in Lower Body Dressing (M1820)
 Improvement in Bathing (M1830)
 Improvement in Toileting Hygiene (M1845)
 Improvement in Eating (M1870)

    The proposed Total Normalized Composite Change in Mobility measure 
computes the magnitude of change, either positive or negative, based on 
the normalized amount of possible change on each of three OASIS-based 
quality outcomes. These three outcomes are as follows:

 Improvement in Toilet Transferring (M1840)
 Improvement in Bed Transferring (M1850)
 Improvement in Ambulation/Locomotion (M1860)

    The magnitude of possible change for these OASIS items varies based 
on the number of response options. For example, M1800 (grooming) has 
four behaviorally-benchmarked response options (0 = most independent; 3 
= least independent) while M1830 (bathing) has seven behaviorally-
benchmarked response options (0 = most independent; 6 = least 
independent). The maximum possible change for a patient on item M1800 
is 3, while the maximum possible change for a patient on item M1830 is 
6. We indicated that both proposed composite measures would be computed 
and normalized at the episode level, then aggregated to the HHA level 
using the following steps:
     Step 1: Calculate absolute change score for each OASIS 
item (based on

[[Page 56530]]

change between Start of Care (SOC)/Resumption of Care (ROC) and 
discharge) used to compute the Total Normalized Composite Change in 
Self-Care (6 items) or Total Normalized Composite Change in Mobility (3 
items) measures.
     Step 2: Normalize scores based on maximum change possible 
for each OASIS item (which varies across different items). The 
normalized scores result in a maximum possible change for any single 
item equal to ``1''; this score is provided when a patient achieves the 
maximum possible change for the OASIS item.
     Step 3: Total score for Total Normalized Composite Change 
in Self-Care or Total Normalized Composite Change in Mobility is 
calculated by summing the normalized scores for the items in the 
measure. Hence, the maximum possible range of normalized scores at the 
patient level for Total Normalized Composite Change in Self-Care is -6 
to +6, and for Total Normalized Composite Change in Mobility is -3 to 
+3.
    We created two prediction models for the proposed Total Normalized 
Composite Change in Self-Care (TNC_SC) and Total Normalized Composite 
Change in Mobility (TNC_MOB) measures using information from OASIS 
items and patient clinical condition categories (see Table 37 for 
details on the number of OASIS items and OASIS clinical categories used 
in the prediction models). We computed multiple ordinary least squares 
(OLS) analyses beginning with risk factors that were available from 
OASIS D items and patient condition groupings. Any single OASIS D item 
might have more than one risk factor because we create dichotomous risk 
factors for each response option on scaled (from dependence to 
independence) OASIS items. Those risk factors that were statistically 
significant at p<0.0001 level were kept in the prediction model. These 
two versions (CY 2014 and CY 2015) of the prediction models were done 
as ``proof of concept.'' We proposed that the actual prediction models 
for the composite measures, if finalized, would use episodes of care 
that ended in CY 2017, which we proposed would be the baseline year for 
the quality outcome measures used to compute the two proposed composite 
measures, as listed previously. The baseline year for these two 
composite measures would be CY 2017.
    The following table (Table 37) provides an overview of results from 
the CY 2014 and CY 2015 prediction models for each proposed measure 
with estimated R-squared values comparing observed vs. predicted 
episode-level performance. This same information was included in Table 
50 of the CY 2019 HH PPS proposed rule (83 FR 32428 through 32429).
[GRAPHIC] [TIFF OMITTED] TR13NO18.063

    Table 37 presents the following summary information for the 
prediction models for the two proposed composite measures.
     Prediction Model for: This column identifies the measure 
and year of data used for the two ``proof of concept'' prediction 
models created for each of the two proposed composite measures, Total 
Normalized Composite Change in Self-Care (TNC_SC) and Total Normalized 
Composite Change in Mobility (TNC_MOB). The development of the 
prediction models was identical in terms of the list of potential risk 
factors and clinical categories. The only difference was one set of 
prediction models used episodes of care that ended in CY 2014, while 
the other set of prediction models used episodes of care that ended in 
CY 2015.
     Number of OASIS Items Used: This column indicates the 
number of OASIS items used as risk factors in the prediction model. For 
each prediction model, the number of OASIS items used is based on the 
number of risk factors that were statistically significant at p<0.0001 
level in the prediction model.
     Number of Clinical Categories: This column indicates the 
number of patient clinical categories (for example, diagnoses related 
to infections or neoplasms or endocrine disorders) that are used as 
risk factors in the prediction model.
     R-squared Value: The R-squared values are a measure of the 
proportion of the variation in outcomes that is accounted for by the 
prediction model. The results show that the methodology that was used 
to create the prediction models produced very consistent models that 
predict at least 29 percent of the variability in the proposed 
composite measures.
    The prediction models are applied at the episode level to create a 
specific predicted value for the composite measure for each episode of 
care. These episode level predicted values are averaged to compute a 
national predicted value and an HHA predicted value. The episode level 
observed values are averaged to compute the HHA observed value. The HHA 
TNC_SC and TNC_MOB observed scores are risk adjusted based on the 
following formula:

HHA Risk Adjusted = HHA Observed + National Predicted - HHA Predicted

    We explained in the proposed rule that HHAs are not allowed to skip 
any of the OASIS items that are used to compute these proposed 
composite measures or the risk factors that comprise the prediction 
models for the two proposed composite measures. The OASIS items 
typically do not include ``not available (NA)'' or ``unknown (UK)'' 
response options, and per HHQRP requirements,\41\ HHAs must provide 
responses to all OASIS items for

[[Page 56531]]

the OASIS assessment to be accepted into the CMS data repository. 
Therefore, while we believed the likelihood that a value for one of 
these items would be missing is extremely small, we proposed to impute 
a value of ``0'' if a value is ``missing.'' Specifically, if for some 
reason the information on one or more OASIS items that are used to 
compute TNC_SC or TNC_MOB is missing, we impute the value of ``0'' (no 
change) for the missing value. Similarly, if for some reason the 
information on one or more OASIS items that are used as a risk factor 
is missing, we impute the value of ``0'' (no effect) for missing values 
that comprise the prediction models for the two proposed composite 
measures. We presented summary information for these two proposed 
composite measures in Table 51 of the proposed rule (83 FR 32429 
through 32431). We explained that because the proposed TNC_SC and 
TNC_MOB are composite measures rather than simple outcome measures, the 
terms ``Numerator'' and ``Denominator'' do not apply to how these 
measures are calculated. Therefore, for these proposed composite 
measures, the ``Numerator'' and ``Denominator'' columns in Table 51 of 
the proposed rule were replaced with columns describing ``Measure 
Computation'' and ``Risk Adjustment.''
---------------------------------------------------------------------------

    \41\ Data Specifications--https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/DataSpecifications.html.
---------------------------------------------------------------------------

    We invited public comment on our proposals to replace three OASIS-
based measures, Improvement in Ambulation-Locomotion, Improvement in 
Bed Transferring, and Improvement in Bathing, with two proposed 
composite measures, Total Normalized Composite Change in Self-Care and 
Total Normalized Composite Change in Mobility, for PY4 and subsequent 
performance years.
    Comment: Many commenters supported replacing the three OASIS-based 
measures, Improvement in Ambulation-Locomotion, Improvement in Bed 
Transferring, and Improvement in Bathing, with the two composite 
measures, Total Normalized Composite Change in Self-Care and Total 
Normalized Composite Change in Mobility. Some commenters, including 
MedPAC, expressed concerns with the composite measures, stating that 
such measures represent reporting elements completely within the 
control of HHAs and may incentivize them to change their coding 
practices in order to improve performance on such measures (and thus, 
positively affect risk-adjustment or payment adjustments in their 
favor). Another commenter questioned the methodology for the maximum 
possible change calculation, as each patient's maximum score for a 
specific question would be based upon the total number of responses 
possible for that OASIS question. The commenter was concerned that this 
methodology does not create an equal ability for HHAs to improve 
outcomes for certain populations of patients, such as those who benefit 
from home health physical therapy but have limited ability to improve 
upon scores on certain OASIS items such as transferring due to chronic 
musculoskeletal or neurological conditions. This same commenter 
questioned the use of a CY 2017 baseline year for these new composite 
measures, rather than the CY 2015 baseline year used for the other 
measures in the measure set, which it believed added complexity to the 
model. Another commenter expressed concern about the proposed Total 
Normalized Composite Change in Self Care measure, citing that the 
proposed composite measure uses outcome measures that are not currently 
included in the HHVBP Model and have not been a priority focus for 
quality improvement for agencies participating in the HHVBP Model.
    Response: With regard to the concerns raised by MedPAC and others 
regarding the data elements that comprise the composite measures, we 
note that we are also finalizing our proposal (as discussed elsewhere 
in this final rule with comment period) to reduce the weight of the 
OASIS-based measures relative to the other measure areas (claims-based 
and HHCAHPS). Although we continue to believe that the OASIS-based 
measures yield reliable information for assessing HHAs' quality 
performance and capture important information about beneficiaries' 
function and improvement, our weighting methodology will increase the 
collective weight of the claims-based and HHCAHPS measures, which 
utilize data from claims and patient surveys and not self-reported 
data, relative to the OASIS-based measures. Regarding the commenter's 
concerns with the composite measure methodology, as discussed 
previously, our methodology uses normalized scores that take into 
account the difference in measure response scales, and result in a 
maximum possible change for any single OASIS item that is equal to 
``1'' regardless of the possible range of response options for that 
particular OASIS item. This methodology accounts for changes to the 
scores on individual OASIS items while also taking into account that 
not all patients are able to significantly improve on all aspects of 
each composite measure. In the case of patients with certain chronic 
conditions where there is limited ability to improve on some areas of 
mobility, as the commenter noted, such beneficiaries may still benefit 
from home health care services such as physical therapy. We believe 
that including the composite measure (versus including one or more 
individual OASIS items related to transfers, which would place more 
weight on those individual items) will encourage HHAs to focus on 
improving overall mobility without penalizing HHAs that are unable to 
improve on OASIS scores for certain patients on a particular item. 
Regarding the comment that CMS is adding complexity to the model by 
using CY 2017 as the baseline year for the composite measures rather 
than the CY 2015 baseline year used for the remainder of the measures 
in the measure set, we note that, as we indicated in the CY 2016 HH PPS 
final rule, for the starter set of quality measures used in the model, 
2015 would consistently be used as the baseline period in order to 
evaluate the degree of change that may occur over the multiple years of 
the model (80 FR 68681). These new composite measures were not part of 
the model's starter set. We believe that using more currently available 
calendar year data to assess HHA performance on these new composite 
measures will result in a more accurate performance score.
    Finally, while not all of the OASIS items that comprise the Total 
Normalized Composite Change in Self Care composite measure are 
currently included in the measure set for the HHVBP Model, the 
composite measure would use data on these OASIS items that are already 
collected from the participating HHAs. All HHAs must report such data 
in order to meet the requirements for certification as an HHA, per the 
Medicare Conditions of Participation (CoP) requirements at Sec.  
484.55(c)(2). The individual OASIS items included in the Self-Care and 
Mobility composite measures focus on areas that target broad clinical 
goals related to therapy provided in the home setting: Improvement in 
ability to conduct activities of daily living for oneself (that is, 
dressing and bathing) and improvement in mobility (that is, ability to 
transfer). While not all of the individual OASIS items that comprise 
the composite measures are currently included in the HHVBP Model 
measure set, they reflect activities and goals that are consistent with 
the goals of the HHVBP Model: To encourage HHAs to improve the quality 
of care for beneficiaries. We expect that HHAs already focus on 
improvement in such areas not just because such items are included in 
the OASIS or are required

[[Page 56532]]

to be reported in order to become a Medicare-certified HHA, but also 
because self-care and mobility are areas of great importance to 
patients and families and improvement in such areas may allow 
beneficiaries to remain in the home setting (versus an institution) and 
contribute to beneficiaries' quality of life. Furthermore, we note that 
the Conditions of Participation require OASIS accuracy and that 
monitoring and reviewing is done by CMS surveyors. CMS also conducts 
activities to validate the same self-reported OASIS data that is used 
for payment.
    Comment: Many commenters suggested that stabilization measures 
should be recognized in HHVBP as opposed to just focusing on 
improvement measures, given that stabilization is sometimes a more 
realistic goal than improvement for certain patients.
    Response: We previously discussed our analyses of existing measures 
relating to stabilization in the CY 2016 HH PPS final rule. 
Specifically, we stated that while we considered using some of the 
stabilization measures for this model, we found that in contrast to the 
average HHA improvement measure scores which ranged from 56 to 65 
percent, the average HHA stabilization measure scores ranged from 94 to 
96 percent. Using measures where the average rates are nearly 100 
percent would not allow for meaningful comparisons between competing 
HHAs on the quality of care delivered (80 FR 68669 through 68670). 
While the commenters did not suggest specific stabilization measures 
for our consideration, we note that in the years since the CY 2016 HH 
PPS final rule was published, we have continued to explore whether the 
inclusion of stabilization measures may be appropriate for the HHVBP 
Model, however we have not identified any such measures that we believe 
would allow for meaningful comparison of HHA performance. Although we 
appreciate commenters' concerns that some beneficiaries may have 
limited opportunity to improve and that stabilization may be a more 
realistic goal for such patients, based on these analyses, we do not 
believe these measures are appropriate for inclusion in the Model at 
this time.
    Final Decision: After consideration of the public comments we 
received and for the reasons we discussed previously, we are finalizing 
our proposal to replace three OASIS-based measures, Improvement in 
Ambulation-Locomotion, Improvement in Bed Transferring, and Improvement 
in Bathing, with two composite measures, Total Normalized Composite 
Change in Self-Care and Total Normalized Composite Change in Mobility, 
for PY4 and subsequent performance years.
    Table 38 reflects our finalized polices to remove the Influenza 
Immunization Received for Current Flu Season and Pneumococcal 
Polysaccharide Vaccine Ever Received measures and to replace the 
Improvement in Ambulation-Locomotion, Improvement in Bed Transferring, 
and Improvement in Bathing measures with the new Total Normalized 
Composite Change in Self-Care and Total Normalized Composite Change in 
Mobility measures. Table 38 identifies the applicable measures set for 
PY4 and each subsequent performance year until such time that another 
set of applicable measures, or changes to this measure set, are 
proposed and finalized in future rulemaking.
BILLING CODE 4120-01-P

[[Page 56533]]

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[[Page 56534]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.065


[[Page 56535]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.066


[[Page 56536]]


3. Reweighting the OASIS-Based, Claims-Based, and HHCAHPS Measures
    In the CY 2016 HH PPS final rule, we finalized weighting measures 
within each of the HHVBP Model's four classifications (Clinical Quality 
of Care, Care Coordination and Efficiency, Person and Caregiver-
Centered Experience, and New Measures) the same for the purposes of 
payment adjustment. We finalized weighting each individual measure 
equally because we did not want any one measure within a classification 
to be more important than another measure, to encourage HHAs to 
approach quality improvement initiatives more broadly, and to address 
concerns where HHAs may be providing services to beneficiaries with 
different needs. Under this approach, a measure's weight remains the 
same even if some of the measures within a classification group have no 
available data. We stated that in subsequent years of the Model, we 
would monitor the impact of equally weighting the individual measures 
and may consider changes to the weighting methodology after analysis 
and in rulemaking (80 FR 68679).
    For PY4 and subsequent performance years, we proposed to revise how 
we weight the individual measures and amend Sec.  484.320(c) 
accordingly (83 FR 32431). Specifically, we proposed to change our 
methodology for calculating the Total Performance Score (TPS) by 
weighting the measure categories so that the OASIS-based measure 
category and the claims-based measure category would each count for 35 
percent and the HHCAHPS measure category would count for 30 percent of 
the 90 percent of the TPS that is based on performance of the Clinical 
Quality of Care, Care Coordination and Efficiency, and Person and 
Caregiver-Centered Experience measures. We noted that these measures 
and their proposed revised weights would continue to account for the 90 
percent of the TPS that is based on the Clinical Quality of Care, Care 
Coordination and Efficiency, and Person and Caregiver-Centered 
Experience measures. Data reporting for each New Measure would continue 
to have equal weight and account for the 10 percent of the TPS that is 
based on the New Measures collected as part of the Model. As discussed 
further in the proposed rule and in this final rule with comment 
period, we stated that we believe that this proposed reweighting, to 
allow more weight for the claims-based measures, would better support 
improvement in those measures.
    We explained in the proposed rule that weights would also be 
adjusted under our proposal for HHAs that are missing entire measure 
categories. For example, if an HHA is missing all HHCAHPS measures, the 
OASIS and claims-based measure categories would both have the same 
weight (50 percent each). We stated that we believe that this approach 
would also increase the weight given to the claims-based measures, and 
as a result give HHAs more incentive to focus on improving them. 
Additionally, if measures within a category are missing, the weights of 
the remaining measures within that measure category would be adjusted 
proportionally, while the weight of the category as a whole would 
remain consistent. We also proposed that the weight of the Acute Care 
Hospitalization: Unplanned Hospitalization during first 60 days of Home 
Health claims-based measure would be increased so that it has three 
times the weight of the Emergency Department Use without 
Hospitalization claims-based measure, based on our understanding that 
HHAs may have more control over the Acute Care Hospitalization: 
Unplanned Hospitalization during first 60 days of Home Health claims-
based measure. In addition, because inpatient hospitalizations 
generally cost more than ED visits, we stated that we believe 
improvement in the Acute Care Hospitalization: Unplanned 
Hospitalization during first 60 days of Home Health claims-based 
measure may have a greater impact on Medicare expenditures.
    We proposed to reweight the measures based on our ongoing 
monitoring and analysis of claims and OASIS-based measures, which shows 
that there has been a steady improvement in OASIS-based measures, while 
improvement in claims-based measures has been relatively flat. For 
example, Figures 1 and 2 (which were included as Figures 5 and 6 in the 
proposed rule) show the change in average performance for the claims-
based and OASIS-based performance measures used in the Model. For both 
figures, we report the trends observed in Model and non-Model states. 
In both Model and non-Model states, there has been a slight increase 
(indicating worse performance) in the Acute Care Hospitalization: 
Unplanned Hospitalization during first 60 days of Home Health measure. 
For all OASIS-based measures, except the Improvement in Management of 
Oral Medications measure and the Discharge to Community measure, there 
has been substantial improvement in both Model and non-Model states. 
Given these results, we stated that we believe that increasing the 
weight given to the claims-based measures, and the Acute Care 
Hospitalization: Unplanned Hospitalization during first 60 days of Home 
Health measure in particular, may give HHAs greater incentive to focus 
on quality improvement in the claims-based measures. Increasing the 
weight of the claims-based measures was also supported by our 
contractor's TEP.

[[Page 56537]]

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[[Page 56538]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.068

    Table 52 of the proposed rule (83 FR 32434) showed the current 
weighting and the proposed revised weighting for each measure based on 
our proposal to change the weighting methodology from weighting each 
individual measure equally to weighting the OASIS, claims-based, and 
HHCAHPS measure categories at 35-percent, 35-percent and 30-percent, 
respectively. Table 52 of the proposed rule also showed the proposed 
weighting methodology based on various scoring scenarios. This same 
information is presented in Table 39 of this final rule with comment 
period. For example, for HHAs that are exempt from their beneficiaries 
completing HHCAHPS surveys, the total weight given to OASIS-based 
measures scores would be 50 percent, with all OASIS-based measures 
(other than the two composite measures) accounting for an equal 
proportion of that 50 percent, and the total weight given to the 
claims-based measures scores would be 50 percent, with the Acute Care 
Hospitalization: Unplanned Hospitalizations measure accounting for 
37.50 percent and the ED Use without Hospitalization measure accounting 
for 12.50 percent. The OASIS- and claims-based measure categories would 
have equal weights in this scenario because the weight for each 
remaining category when one category is missing is based on the 
relative weight of the category when all three are present. Because 
both the OASIS- and claims-based categories would have a weight of 35% 
when HHCAHPS data is reported, each would have a 50% weight if HHCAHPS 
data is not available. However, if no claims-based measure data is 
available, the OASIS-based measures would have a higher weight than the 
HHCAHPS category, because their weights when all three categories are 
available are 35% and 30%, respectively. Finally, both Table 52 of the 
proposed rule and Table 39 of this final rule with comment period show 
the change in the number of HHAs, by size, that would qualify for a TPS 
and payment adjustment under the current and proposed reweighting 
methodologies, using CY 2016 data. We noted in the proposed rule that 
Table 52 only reflects the proposed changes to the weighting 
methodology, and not the other proposed changes to the HHVBP model for 
CY 2019 which, if finalized, would change the proposed weights as set 
forth in Table 52 (and Table 39 of this final rule with comment 
period). We referred readers to Table 65 of the proposed rule (83 FR 
32506) which reflected the weighting that would apply if all of our 
proposed changes, including the proposed changes to the applicable 
measure set, were adopted for CY 2019. We indicated that as reflected 
in that table, the two proposed composite measures, if finalized, would 
have weights of 7.5 percent when all three measure categories are 
reported. For purposes of this final rule with comment period, we refer 
readers to Table 50 of this final rule with comment period, which 
reflects the weighting that will apply beginning in CY 2019 based on 
all of our finalized proposals, including the finalized reweighting and 
our finalized changes to the applicable measure set. As reflected in 
Table 50 of this final rule with comment period, the two finalized 
composite measures will have weights of 7.5 percent when all three 
measure categories are reported.

[[Page 56539]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.069

BILLING CODE 4120-01-C
    We invited public comments on the proposal to reweight the measures 
within the Clinical Quality of Care, Care Coordination and Efficiency, 
and Person

[[Page 56540]]

and Caregiver-Centered Experience classifications so that the OASIS-
based measures account for 35-percent, the claims-based measures 
account for 35-percent, and the HHCAHPS account for 30-percent of the 
90 percent of the TPS that is based on performance on these measures, 
for PY4 and subsequent performance years. We also proposed to amend 
Sec.  484.320 to reflect these proposed changes. Specifically, we 
proposed to amend Sec.  484.320 to state that for performance years 4 
and 5, CMS will sum all points awarded for each applicable measure 
within each category of measures (OASIS-based, claims-based, and 
HHCAHPS) excluding the New Measures, weighted at 35-percent for the 
OASIS-based measure category, 35-percent for the claims-based measure 
category, and 30-percent for the HHCAHPS measure category, to calculate 
a value worth 90-percent of the Total Performance Score. We also 
included a sample calculation in Table 53 of the proposed rule (83 FR 
32435) to show how this proposal, in connection with the proposed 
changes to the measure set, would affect scoring under the model as set 
forth in prior rulemaking (80 FR 68679 through 68686) when all three 
measure categories are reported.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters generally supported the reweighting of the 
measure categories for the purpose of encouraging additional focus on 
the claims-based measures, and also supported the proposed revised 
weights. Some commenters were concerned that reweighting the Acute Care 
Hospitalization: Unplanned Hospitalization during first 60 days of Home 
Health claims-based measure to be three times the weight of the 
Emergency Department Use without Hospitalization claims-based measure 
would make one measure too impactful for the overall TPS, and that 
significant weight on a single measure would encourage HHAs to focus on 
that one measure at the expense of other measures. A commenter 
suggested that the claims-based measure category should be reweighted 
higher, such as 60 percent, because the commenter believed that claims-
based measures were less likely to be subject to data manipulation than 
measures based on self-reported data. Another commenter recommended an 
increase in weighting for claims-based measures when HHCAHPS data are 
not available. MedPAC supported weighting claims measures more and 
recommended the OASIS measures be weighted less than the HHCAHPS 
measures because they believe that patient experience can be an 
important way to assess quality of care.
    Response: We appreciate the comments supporting reweighting in 
general as well as our proposed reweighting percentages. We proposed to 
weight the Acute Care Hospitalization: Unplanned Hospitalization during 
first 60 days of Home Health claims-based measure three times the 
weight of the Emergency Department Use without Hospitalization claims-
based measure because of our belief that HHAs have greater ability to 
improve upon the Acute Care Hospitalization: Unplanned Hospitalization 
during first 60 days of Home Health claims-based measure than the ED 
measure, given that beneficiaries can self-refer to the ED but a 
hospitalization requires more direct clinician involvement (from either 
HHA staff or a community clinician with whom the HHA should be 
coordinating care) for an admission. As noted in the proposed rule, 
because inpatient hospitalizations generally cost more than ED visits, 
we also believe quality improvement in the Acute Care Hospitalization: 
Unplanned Hospitalization during first 60 days of Home Health claims-
based measure may have a greater impact on reducing Medicare 
expenditures. We plan to monitor and evaluate the impact of weighting 
the Acute Care Hospitalization: Unplanned Hospitalization during first 
60 days of Home Health claims-based measure three times the weight of 
the Emergency Department Use without Hospitalization claims-based 
measure.
    With regard to the commenter's suggestion to reweight the claims-
based measures to 60 percent, we are concerned that such an approach 
would encourage HHAs to focus on the claims-based measures (and 
particularly the Unplanned Hospitalization measure) at the expense of 
other quality improvement efforts, such as patient experience and 
mobility improvement, which are assessed through HHCAHPS and the OASIS 
measures. We are attempting to balance encouraging HHAs to focus on 
measures that may more heavily impact Medicare expenditures (such as 
the claims-based measures) with ensuring that HHAs focus on quality 
improvement across various focus areas, including those which are not 
directly measured through the claims-based measures, such as patient 
experience and mobility. As such, we do not believe we should increase 
the weight for claims-based measures above what we have proposed when 
HHCAHPS data are not available; rather, we believe a more gradual 
approach is appropriate for increasing HHAs' focus on claims-based 
measures. In addition, we continue to believe that OASIS-based measures 
provide important information about quality of care and want to 
continue to encourage HHAs to further improve on such measures. 
Finally, with regard to MedPAC's suggestion to weight the HHCAHPS 
higher than the OASIS-based measures, we agree with MedPAC that 
measuring patient experience during home health episodes is important. 
As discussed in this section, while we proposed to weight the HHCAHPS 
category less than the other two categories, the overall change in the 
weight for the HHCAHPS is not significant. As Table 50 reflects, 
HHCAHPS were reduced from 31.25 percent to 30.00 percent for the 
category and from 6.25 percent to 6.00 percent for each individual 
HHCAHPS measure under our proposal. A greater reduction actually occurs 
for the OASIS-based measures (as shown in Table 50, total weight for 
OASIS measures goes from 56.25 percent to 35.00 percent for the 
category and 6.25 percent to 5.00 percent for individual OASIS 
measures, other than the two new composite measures). This is because 
under current policy each HHCAHPS, OASIS-based, and claims-based 
measure is weighted equally and because the number of measures in each 
category differs. We believe the proposed reweighting balances our 
interest in encouraging focus on claims-based measures as well as on 
the patient experience and OASIS-based measures.
    Comment: Several commenters suggested the weight of the HHCAHPS 
measures category should not be reduced because they are concerned that 
HHAs may focus less on improving upon HHCAHPS. Another commenter 
suggested that the HHCAHPS measure category should not have a lower 
weight than the OASIS measures category because the commenter believes 
that a lower weight would suggest that patient experience is less 
important than the other measures.
    Response: We acknowledge the importance of the HHCAHPS measures and 
gave them serious consideration when proposing measure category 
reweighting. In considering revisions to the weights for HHCAHPS versus 
the other measures, we attempted to balance placing more emphasis on 
claims-based measures (which may have a greater impact on Medicare 
expenditures) with continuing to encourage HHAs to focus on patient 
experience. We note that while the OASIS measures category will

[[Page 56541]]

be reweighted from 56.25 percent to 35.0 percent (a reduction of 21.25 
percent), the HHCAHPS measures category will be reweighted from 31.25 
percent to 30 percent (a reduction of only 1.25 percent). We believe 
this moderate reweighting of the HHCAHPS measures category is 
appropriate because smaller HHAs are not required to submit their 
HHCAHPS measure scores due to their limited episodes of care, and 
therefore we believe that more weight should be allotted to measure 
categories with broader HHVBP Model reporting across HHAs of all types. 
However, as noted, our proposal only reduces the HHCAHPS weights very 
slightly, which is consistent with our belief and the view expressed by 
several commenters that patient experience is a crucial component of 
quality measurement during home health episodes. Based on our 
examination of performance data, we proposed to increase the weight of 
the claims-based measures, while still seeking to encourage HHAs to 
focus on other measure categories. CMS will also monitor and evaluate 
the impact of the reweighting of the overall measure categories and 
determine if additional adjustments are necessary in future years 
through rulemaking.
    Comment: Some commenters suggested that CMS should delay measure 
category reweighting or maintain the current weighting methodology 
because they believe that HHAs need more time to adapt to the HHVBP 
Model, and that CMS should wait for information on behavioral impacts 
from the new PDGM prior to making additional changes to HHVBP. Other 
commenters suggested that making changes, such as reweighting, would 
make the HHVBP Model difficult to evaluate and create an unfair 
environment for HHAs.
    Response: We carefully considered the impact on HHAs of our 
proposed changes to reweight the measure categories, as well as the 
effects on quality improvement for beneficiaries. We proposed to 
reweight the measure categories to allow for more weight to the claims-
based measures to encourage further improvement on those measures, and 
place increased focus on accountability for areas of significant 
Medicare spending, such as hospitalizations. Because these measures 
have been a part of the HHVBP model's applicable measure set from the 
start of the model, we believe HHAs will have sufficient time to 
appropriately adjust business practices and care methods as needed in 
light of the proposed reweighting. The evaluation of the HHVBP model 
will take into account changes in the model methodology and in the 
corresponding HHA environment, such as changes to the Home Health 
Prospective Payment System.
    Comment: Some commenters believed that the proposed reweighting may 
disincentivize some HHAs from serving vulnerable populations that are 
at risk for hospitalizations. A commenter stated that the proposed 
reweighting may incentivize further hospital stays.
    Response: We believe that the reweighting will encourage HHAs to 
further enhance their service structures to appropriately address the 
needs of Medicare beneficiaries of all types by using quality 
improvement processes that support the Model's quality measures, 
including processes intended to reduce hospitalizations. We do not 
believe that reweighting the measures would discourage HHAs from 
serving vulnerable populations or incentivize further hospital stays. 
Rather, we believe that reweighting the measures to increase the 
emphasis on the claims-based ED use and unplanned hospitalization 
measures would encourage HHAs to increase the coordination with other 
providers and suppliers such as physicians and inpatient facilities 
(hospitals and post-acute care (PAC) facilities) in order to reduce ED 
visits and hospital admissions. We note that the claims-based ED and 
hospitalization measures are included in the HH QRP and reflect goals 
consistent with other CMS initiatives that focus on reducing avoidable 
hospital admissions, such as the Hospital Readmissions Reduction 
Program. We expect the proposed increase in the weight of these ED and 
hospitalization measures to incentivize avoiding hospital stays, not 
additional hospitalizations. We also do not expect that the reweighting 
will cause HHAs to implement policies that do not serve vulnerable 
populations at risk of hospitalization, but will instead encourage care 
coordination between HHAs and other health care providers to avoid 
hospitalizations, which may result in improved care for all 
beneficiaries, including vulnerable populations. Moreover, in 
determining the reweighting percentages, we proposed a weight of 30 
percent for HHCAHPS in order to ensure patient experience across all 
vulnerable populations is not negatively affected by the reweighting. 
Finally, we note that HHAs in the HHVBP Model have opportunities to 
share strategies for success under the model, including reducing 
hospitalizations, through specialized technical assistance and learning 
events provided through the Model.
    Comment: A commenter suggested that the proposed reweighting was 
arbitrary and that providers should be evaluated based on the most 
important aspects of care.
    Response: We disagree that the proposed reweighting was arbitrary. 
The HHVBP model examines a broad array of quality measures that address 
critical quality areas. The selected measures are intended to have a 
high impact on care delivery and support the combined priorities of HHS 
and CMS to improve health outcomes, quality, safety, efficiency, and 
experience of care for patients. As discussed in response to other 
comments, the claims-based ED and hospitalization measures are included 
in the HH QRP and reflect goals consistent with other CMS initiatives 
that focus on reducing avoidable hospital admissions, and we believe 
our proposed reweighting will encourage increased focus on 
accountability for areas of significant Medicare spending, such as 
hospitalizations.
    Final Decision: For the reasons stated and after consideration of 
the comments received, we are finalizing the measure category 
reweighting as proposed. Specifically, we are finalizing our proposal 
to change our methodology for calculating the Total Performance Score 
(TPS) by weighting the measure categories so that the OASIS-based 
measure category and the claims-based measure category will each count 
for 35 percent and the HHCAHPS measure category will count for 30 
percent of the 90 percent of the TPS that is based on performance on 
the Clinical Quality of Care, Care Coordination and Efficiency, and 
Person and Caregiver-Centered Experience measures. We refer readers to 
Table 50 in section X. Regulatory Impact Analysis of this final rule 
with comment period, which reflects the weighting that will apply 
beginning in CY 2019 based on all of our finalized proposals, including 
the finalized reweighting and our finalized changes to the applicable 
measure set. We are also finalizing our proposed amendments to Sec.  
484.320 without change. Specifically, we are amending Sec.  484.320 to 
state that for performance years 4 and 5, CMS will sum all points 
awarded for each applicable measure within each category of measures 
(OASIS-based, claims-based, and HHCAHPS) excluding the New Measures, 
weighted at 35-percent for the OASIS-based measure category, 35-percent 
for the claims-based measure category, and 30-percent for the HHCAHPS 
measure category, to

[[Page 56542]]

calculate a value worth 90-percent of the Total Performance Score. 
Table 40 (which is identical to Table 53 of the proposed rule) is a 
sample calculation to show how this finalized policy, in connection 
with the finalized changes to the measure set, will affect the scoring 
under the model, as set forth in prior rulemaking (80 FR 68679 through 
68686), when all three measure categories are reported.
[GRAPHIC] [TIFF OMITTED] TR13NO18.070

C. Performance Scoring Methodology

1. Rescoring the Maximum Amount of Improvement Points
    In the CY 2016 HH PPS final rule, we finalized that an HHA could 
earn 0 to 10 points based on how much its performance in the 
performance period improved from its performance on each measure in the 
Clinical Quality of Care, Care Coordination and Efficiency, and Person 
and Caregiver-Centered Experience classifications during the baseline 
period. We noted, in response to public comment about our scoring 
methodology for improvement points, that we will monitor and evaluate 
the impact of awarding an equal amount of points for both achievement 
and improvement and may consider changes to the weight of the 
improvement score relative to the achievement score in future years 
through rulemaking (80 FR 68682).
    We proposed to reduce the maximum amount of improvement points, 
from 10 points to 9 points, for PY4 and subsequent performance years 
for all measures except for the Total Normalized Composite Change in 
Self-Care and Total Normalized Composite Change in Mobility measures, 
for which we proposed the maximum improvement points would be 13.5 (83 
FR 32435). The maximum score of 13.5 represents 90 percent of the 
maximum 15 points that could be earned for each of the two composite 
measures. The HHVBP Model focuses on having all HHAs provide high 
quality care and we stated in the proposed rule that we believe that 
awarding more points for achievement than for improvement beginning 
with PY4 of the model would support this goal. We stated that we expect 
that at this point several years into participation in the Model, 
participating HHAs have had enough

[[Page 56543]]

time to make the necessary investments in quality improvement efforts 
to support a higher level of care, warranting a slightly stronger focus 
on achievement over improvement on measure performance. Furthermore, we 
stated that we believe that reducing the maximum improvement points to 
9 would encourage HHAs to focus on achieving higher performance levels, 
and incentivizing in this manner would encourage HHAs to rely less on 
their improvement and more on their achievement.
    We also stated in the proposed rule that this proposal would be 
consistent with public comments from prior rulemaking, and suggestions 
provided by our contractor's TEP. As summarized in the CY 2016 HH PPS 
final rule, we received comments encouraging us to focus on rewarding 
the achievement of specified quality scores, and reduce the emphasis on 
improvement scores after the initial 3 years of the HHVBP Model. Some 
commenters suggested measuring performance primarily based on 
achievement of specified quality scores with a declining emphasis over 
time on improvement versus achievement (80 FR 68682).
    The TEP also agreed with reducing the maximum number of improvement 
points, which they believed would better encourage HHAs to pursue 
improved health outcomes for beneficiaries. We noted in the proposed 
rule that for the Hospital Value-Based Purchasing (HVBP) Program, CMS 
finalized a scoring methodology where hospitals could earn a maximum of 
9 improvement points if their improvement score falls between the 
improvement threshold and the benchmark (76 FR 26515). We proposed that 
HHVBP would employ a similar scoring methodology where HHAs could earn 
a maximum of 9 improvement points.
    We proposed that an HHA would earn 0-9 points based on how much its 
performance during the performance period improved from its performance 
on each measure in the Clinical Quality of Care, Care Coordination and 
Efficiency, and Person and Caregiver-Centered Experience 
classifications during the baseline period. We stated that a unique 
improvement range for each measure would be established for each HHA 
that defines the difference between the HHA's baseline period score and 
the same state level benchmark for the measure used in the achievement 
scoring calculation, according to the proposed improvement formula. If 
an HHA's performance on the measure during the performance period was--
     Equal to or higher than the benchmark score, the HHA could 
receive an improvement score of 9 points, or 13.5 points for the Total 
Normalized Composite Change in Self-Care and Total Normalized Composite 
Change in Mobility measures (an HHA with performance equal to or higher 
than the benchmark score could still receive the maximum of 10 points 
for achievement (or 15 points, for the composite measures));
     Greater than its baseline period score but below the 
benchmark (within the improvement range), the HHA could receive an 
improvement score of 0-9 based on the formula and as illustrated in the 
examples (except for the Total Normalized Composite Change in Self-Care 
and Total Normalized Composite Change in Mobility measures, for which 
the maximum improvement score would be 13.5, as noted previously); \42\ 
or,
---------------------------------------------------------------------------

    \42\ We note that in the proposed rule (83 FR 32436), we 
inadvertently stated that the HHA could receive a maximum 
improvement score of 15 for these composite measures. As explained 
elsewhere in the proposed rule (83 FR 32435), we proposed that the 
maximum improvement points for these composite measures would be 
13.5.
---------------------------------------------------------------------------

     Equal to or lower than its baseline period score on the 
measure, the HHA could receive zero points for improvement.
[GRAPHIC] [TIFF OMITTED] TR13NO18.071

    We also presented examples of how the proposed changes to the 
performance scoring methodology would be applied in the context of the 
measures in the Clinical Quality of Care, Care Coordination and 
Efficiency, and Person and Caregiver Centered Experience 
classifications (83 FR 32426 through 32438). We invited public comment 
on the proposal to reduce the maximum amount of improvement points, 
from 10 points to 9 points for PY 4 and subsequent performance years. 
The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported rescoring in general and the 
proposed rescoring. A commenter suggested that HHVBP should reward 
agencies based on achievement only, and another commenter stated that 
the proposed rescoring did not go far enough and would still penalize 
high performing agencies.
    Response: We appreciate the positive feedback on our proposed 
methodology. We believe that removing improvement scores from the Model 
could disadvantage smaller HHAs and those HHAs with limited resources. 
Although we proposed to reduce the maximum improvement points, we 
believe that the improvement points continue to play a necessary role 
in promoting the consistent improvement of HHAs within the Model states 
that are not performing equal to or above the state benchmark. We will 
monitor and evaluate the impact of reducing the maximum improvement 
points from 10 to 9 to determine if additional rescoring is necessary 
in future years through rulemaking.
    Final Decision: For the reasons stated and after consideration of 
the comments received, we are finalizing the rescoring of the maximum 
amount of improvement points, as proposed. Specifically, we are 
finalizing the reduction of the maximum amount of improvement points, 
from 10 points to 9 points, for PY4 and subsequent performance years 
for all measures except for the Total Normalized Composite Change in 
Self-Care and Total Normalized Composite Change in Mobility measures, 
for which the maximum improvement points will be 13.5.
2. Examples of Calculating Achievement and Improvement Scores
    For illustrative purposes we present the following examples of how 
the changes to the performance scoring

[[Page 56544]]

methodology will be applied in the context of the measures in the 
Clinical Quality of Care, Care Coordination and Efficiency, and Person 
and Caregiver Centered Experience classifications. These HHA examples 
are based on data from 2015 (for the baseline period) and 2016 (for the 
performance year). We note that the figures and examples presented in 
this final rule with comment period are the same figures and examples 
set forth in the proposed rule (83 FR 32436 through 32438). Figure 3 
shows the scoring for HHA `A' as an example. The benchmark calculated 
for the improvement in pain measure is 97.676 for HHA A (note that the 
benchmark is calculated as the mean of the top decile in the baseline 
period for the state). The achievement threshold was 75.358 (this is 
defined as the performance of the median or the 50th percentile among 
HHAs in the baseline period for the state). HHA A's Year 1 performance 
rate for the measure was 98.348, which exceeds the benchmark so the HHA 
earned the maximum 10 points based on its achievement score. Its 
improvement score is irrelevant in the calculation because measure 
performance exceeded the benchmark.
    Figure 3 also shows the scoring for HHA `B.' HHA B's performance on 
this measure went from 52.168 (which was below the achievement 
threshold) in the baseline period to 76.765 (which is above the 
achievement threshold) in the performance period. Applying the 
achievement scale, HHA B will earn 1.067 points for achievement, 
calculated as follows: 9 * (76.765 - 75.358)/(97.676 - 75.358) + 0.5 = 
1.067.\43\ Calculating HHA B's improvement score yields the following 
result: based on HHA B's period-to-period improvement, from 52.168 in 
the baseline year to 76.765 in the performance year, HHA B will earn 
4.364 points, calculated as follows: 9 * (76.765 - 52.168)/(97.676 - 
52.168) - 0.5 = 4.364.\44\ Because the higher of the achievement and 
improvement scores is used, HHA B will receive 4.364 points for this 
measure.
---------------------------------------------------------------------------

    \43\ Achievement points are calculated as 9 * (HHA Performance 
Year Score - Achievement Threshold)/(Benchmark - Achievement 
threshold) + 0.5.
    \44\ As finalized, the revised formula for calculating 
improvement points is 9 * (HHA Performance Year Score-HHA Baseline 
Period Score)/(HHA Benchmark-HHA Baseline Period Score) - 0.5. We 
note that in the proposed rule (83 FR 32436), we inadvertently 
included the achievement threshold of 75.358 in the denominator of 
this equation rather than HHA B's baseline period score of 52.168, 
however, the calculated figures were correct.
---------------------------------------------------------------------------

    In Figure 4, HHA `C' yielded a decline in performance on the 
improvement in pain measure, falling from 70.266 to 58.487. HHA C's 
performance during the performance period was lower than the 
achievement threshold of 75.358 and, as a result, the HHA will receive 
zero points based on achievement. It will also receive zero points for 
improvement, because its performance during the performance period was 
lower than its performance during the baseline period.

[[Page 56545]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.072


[[Page 56546]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.073

    We will monitor and evaluate the impact of reducing the maximum 
improvement points to 9 and will consider whether to propose more 
changes to the weight of the improvement score relative to the 
achievement score in future years through rulemaking.

D. Update on the Public Display of Total Performance Scores

    In the CY 2016 HH PPS final rule (80 FR 68658), we stated that one 
of the three goals of the HHVBP Model is to enhance the current public 
reporting processes. We reiterated this goal and continued discussing 
the public display of HHAs' Total Performance Scores (TPSs) in the CY 
2017 HH PPS final rule (81 FR 76751 through 76752). We believe that 
publicly reporting a participating HHA's TPS will encourage providers 
and patients to use this information when selecting an HHA to provide 
quality care. We stated in the proposed rule that we were encouraged by 
the previous stakeholder comments and support for public reporting that 
could assist patients, physicians, discharge planners, and other 
referral sources to choose higher-performing HHAs.
    In the CY 2017 HH PPS final rule, we noted that a commenter 
suggested that we not consider public display until after the Model was 
evaluated. Another commenter favored the public display of the TPS, but 
recommended that CMS use a transparent process and involve stakeholders 
in deciding what will be reported, and provide a review period with a 
process for review and appeal before reporting.
    As discussed in the CY 2017 HH PPS final rule, we are considering 
public reporting for the HHVBP Model after allowing analysis of at 
least eight quarters of performance data for the Model and the 
opportunity to compare how these results align with other publicly 
reported quality data (81 FR 76751). While we did not make a specific 
proposal in the CY 2019 HH PPS proposed rule, we solicited further 
public comment on what information, specifically from the CY 2017 
Annual Total Performance Score and Payment Adjustment Reports and 
subsequent annual reports, should be made publicly available. We noted 
that HHAs have the opportunity to review and appeal their Annual Total 
Performance Score and Payment Adjustment Reports 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 
Total Performance Score and Payment Adjustment Report include 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 will consider what information, specifically from 
the annual reports, we may consider proposing for public reporting in 
future rulemaking.
    Comment: Several commenters expressed support for publicly 
reporting information from the Annual Total Performance Score and 
Payment Adjustment Reports as they believe it would better inform 
consumers and allow for more meaningful and objective comparisons among 
HHAs. A commenter suggested that CMS consider providing an actual 
percentile ranking for HHAs along with their TPS as this would provide 
more information to both HHAs and the public. Another commenter 
expressed interest in publicly reporting all information

[[Page 56547]]

relevant to the HHVBP Model such as the agency's performance on the 
individual measures, percentile rankings, and comparison by state and 
cohort. Several commenters expressed concern with publicly displaying 
HHAs' TPSs citing that the methodology is still evolving and this data 
would only represent a subset of home health providers participating in 
the Model. Commenters also pointed out that consumers already have 
access to the quality measures in the Model as the measures themselves 
are already publicly reported on Home Health Compare. A commenter 
recommended not publicly reporting the data until all states are 
participating in the Model because it believes publicly reporting data 
for one state but not the other can be confusing for consumers.
    Response: We appreciate the comments on when and what to publicly 
report and will work to ensure any data that are publicly reported from 
the Annual Total Performance Score and Payment Adjustment Reports are 
thoroughly explained and gives patients, physicians, discharge 
planners, and other referral sources the knowledge they need to choose 
higher-performing HHAs. We intend, if appropriate, to propose what 
would be publicly reported and when in future rulemaking.
    We received a number of out-of-scope comments on policy areas not 
addressed by our proposals, including requests for us to expand the 
HHVBP Model to a national program. We thank the commenters for their 
input and would address any future changes through rulemaking.

V. Home Health Quality Reporting Program (HH QRP)

A. Background and Statutory Authority

    Section 1895(b)(3)(B)(v)(II) of the (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 with 
respect to a year in accordance with this clause, the Secretary is 
directed to reduce the HH 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, for 2015 and each subsequent 
year (except 2018), 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 
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), and the CY 2018 HH 
PPS final rule (82 FR 51711 through 51712).
    Although we have historically used the preamble to the HH PPS 
proposed and final rules each year to remind stakeholders of all 
previously finalized program requirements, we have concluded that 
repeating the same discussion each year is not necessary for every 
requirement, especially if we have codified it in our regulations. 
Accordingly, the following discussion is limited as much as possible to 
a discussion of our proposals, the comments we received on those 
proposals and our responses to those comments, and policies we are 
finalizing for future years of the HH QRP after consideration of the 
comments. We intend to use this approach in our rulemakings for the HH 
QRP going forward.

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

1. Background
    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).
    Comment: A few commenters provided input on several topics 
associated with measure adoption the HH QRP. Specifically, a commenter 
expressed that the pace of removing historical OASIS items has not 
matched the addition of new measures that meet IMPACT Act requirements. 
The same commenter also requested that as IMPACT Act measures are 
added, along with the burden of data collection, the applicability of 
the measures to different settings be taken into consideration. Another 
commenter recommended that measures account for patients who do not 
have a goal of improvement and be tested to ensure their reliability 
and validity in the home setting.
    Response: We appreciate the comments. The removal of historic OASIS 
items has been guided by our assessment regarding their continued need, 
as well as our goal to streamline reporting requirements for HHAs and 
minimize the reporting burden as much as possible. Adopting measures 
that meet IMPACT Act requirements at the same pace that we remove other 
OASIS items would not further our goal to reduce burden.
    We interpret the comment regarding the applicability of quality 
measures across the post-acute care settings to mean that we should 
take into consideration the appropriateness of measures that would be 
used in both institutional and home-based settings. While we believe 
there can be overlap in patient populations across the four post-acute 
care (PAC) providers for which we are required to adopt measures that 
meet requirements under section 1899B of the Act, we recognize that 
each PAC provider setting also has unique attributes, and we take these 
differences into consideration during our measure development and 
maintenance work.
    With regard to the comment that we should consider the adoption of 
measures that take into account patients who may not have goals for 
improvement, we agree that not all patients may have goals associated 
with improvement and we are interested in the utilization of such 
measures that address this population in the HH QRP and in post-acute 
care in general. Further, we agree that such measures should be tested 
to ensure their reliability and validity in the home setting.
2. Accounting for Social Risk Factors in the HH QRP Program
    In the CY 2018 HH PPS final rule (82 FR 51713 through 51714) we 
discussed the importance of improving beneficiary outcomes including 
reducing health disparities. We also discussed our commitment to 
ensuring that medically complex patients, as well as those with social 
risk factors, receive excellent care. We discussed how studies show 
that social risk factors, such as being

[[Page 56548]]

near or below the poverty level as determined by HHS, belonging to a 
racial or ethnic minority group, or living with a disability, can be 
associated with poor health outcomes and how some of this disparity is 
related to the quality of health care.\45\ Among our core objectives, 
we aim to improve health outcomes, attain health equity for all 
beneficiaries, and ensure that complex patients as well as those with 
social risk factors receive excellent care. Within this context, 
reports by the Office of the Assistant Secretary for Planning and 
Evaluation (ASPE) and the National Academy of Medicine have examined 
the influence of social risk factors in our value-based purchasing 
programs.\46\ As we noted in the CY 2018 HH PPS final rule (82 FR 51713 
through 51714), ASPE's report to Congress, which was required by the 
IMPACT Act, found that, in the context of value based purchasing 
programs, dual eligibility was the most powerful predictor of poor 
health care outcomes among those social risk factors that they examined 
and tested. ASPE is continuing to examine this issue in its second 
report required by the IMPACT Act, which is due to Congress in the fall 
of 2019. In addition, as we noted in the FY 2018 IPPS/LTCH PPS final 
rule (82 FR 38428 through 38429), the National Quality Forum (NQF) 
undertook a 2-year trial period in which certain new measures and 
measures undergoing maintenance review have been assessed to determine 
if risk adjustment for social risk factors is appropriate for these 
measures. The trial period ended in April 2017 and a final report is 
available at: http://www.qualityforum.org/SES_Trial_Period.aspx. The 
trial concluded that ``measures with a conceptual basis for adjustment 
generally did not demonstrate an empirical relationship'' between 
social risk factors and the outcomes measured. This discrepancy may be 
explained in part by the methods used for adjustment and the limited 
availability of robust data on social risk factors. NQF has extended 
the socioeconomic status (SES) trial,\47\ allowing further examination 
of social risk factors in outcome measures.
---------------------------------------------------------------------------

    \45\ See United States Department of Health and Human Services. 
``Healthy People 2020: Disparities. 2014.'' Available at: http://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities; or National Academies of Sciences, Engineering, and 
Medicine. Accounting for Social Risk Factors in Medicare Payment: 
Identifying Social Risk Factors. Washington, DC: National Academies 
of Sciences, Engineering, and Medicine 2016.
    \46\ Department of Health and Human Services Office of the 
Assistant Secretary for Planning and Evaluation (ASPE), ``Report to 
Congress: Social Risk Factors and Performance under Medicare's 
Value-Based Purchasing Programs.'' December 2016. Available at: 
https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \47\ Available at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86357.
---------------------------------------------------------------------------

    In the CY 2018/FY 2018 proposed rules for our quality reporting and 
value-based purchasing programs, we solicited feedback on which social 
risk factors provide the most valuable information to stakeholders and 
the methodology for illuminating differences in outcomes rates among 
patient groups within a provider that will also allow for a comparison 
of those differences, or disparities, across providers.
    Feedback we received across our quality reporting programs included 
encouraging CMS to explore whether factors could be used to stratify or 
risk adjust the measures (beyond dual eligibility), to consider the 
full range of differences in patient backgrounds that might affect 
outcomes, to explore risk adjustment approaches, and to offer careful 
consideration of what type of information display will be most useful 
to the public.
    We also sought public comment on confidential reporting and future 
public reporting of some of our measures stratified by patient dual 
eligibility. In general, commenters noted that stratified measures 
could serve as tools for hospitals to identify gaps in outcomes for 
different groups of patients, improve the quality of health care for 
all patients, and empower consumers to make informed decisions about 
health care. Commenters encouraged us to stratify measures by other 
social risk factors such as age, income, and educational attainment. 
With regard to value-based purchasing programs, commenters also 
cautioned CMS to balance fair and equitable payment while avoiding 
payment penalties that mask health disparities or discouraging the 
provision of care to more medically complex patients. Commenters also 
noted that value-based payment program measure selection, domain 
weighting, performance scoring, and payment methodology must account 
for social risk.
    As a next step, we are considering options to improve health 
disparities among patient groups within and across hospitals by 
increasing the transparency of disparities as shown by quality 
measures. We also are considering how this work applies to other CMS 
quality programs in the future. We refer readers to the FY 2018 IPPS/
LTCH PPS final rule (82 FR 38403 through 38409) for more details, where 
we discuss the potential stratification of certain Hospital IQR Program 
outcome measures. Furthermore, we continue to consider options to 
address equity and disparities in our value-based purchasing programs.
    We plan to continue working with ASPE, the public, and other key 
stakeholders on this important issue to identify policy solutions that 
achieve the goals of attaining health equity for all beneficiaries and 
minimizing unintended consequences.
    Comment: Several comments supported continued investigation of ways 
that social risk factors can be applied to quality measures. These 
commenters also provided recommendations for possible social risk 
factors, including family caregiver presence and degree of involvement, 
the Area Deprivation Index, patient preference, needs of specialty 
populations and disproportionate percentage of Medicaid patients. A 
commenter recommended collaboration with Accountable Health Communities 
to measure and eventually mitigate issues for those with advanced 
illness. Another commenter noted that there are statistical methods 
that can adjust for socioeconomic status (SES) factors that are 
independent of quality of care and will not adjust away actual quality 
disparities. The commenter also suggested that we explore the influence 
of neighborhood factors that could be available from other data sources 
and linked to a patient using address information. MedPAC noted that 
CMS should account for social risk factors in quality programs by 
adjusting payment through peer grouping and targeting technical 
assistance to low-performing providers. A few commenters expressed 
support for rewarding better outcomes for beneficiaries with social 
risk factors. Commenters also expressed support for the reporting of 
stratified outcomes measures to providers.
    Response: We thank the commenters for their comments and will take 
them into account as we further consider how to appropriately account 
for social risk factors in the HH QRP. We also refer the reader to the 
CY 2018 HH PPS final rule (82 FR 51713 through 51714), where we 
discussed many of the issues raised by these commenters.

C. Removal Factors for Previously Adopted HH QRP Measures

    As a part of our Meaningful Measures Initiative, discussed in 
section I.D.1 of this final rule with comment period and in the CY 2019 
HH PPS proposed rule (83 FR 32440 through 32441), we strive to put 
patients first, ensuring that they,

[[Page 56549]]

along with their clinicians, are empowered to make decisions about 
their own healthcare using data-driven information that is increasingly 
aligned with a parsimonious set of meaningful quality measures. We 
stated that we began reviewing the HH QRP measure set in accordance 
with the Meaningful Measures Initiative discussed in section I.D.1 of 
this final rule with comment period and in the CY 2019 HH PPS proposed 
rule (83 FR 32440 through 32441), and that we are working to identify 
how to move the HH QRP forward in the least burdensome manner possible, 
while continuing to prioritize and incentivize improvement in the 
quality of care provided to patients.
    Specifically, we stated our belief that the goals of the HH QRP and 
the measures used in the program overlap with the Meaningful Measures 
Initiative priorities, including making care safer, strengthening 
person and family engagement, promoting coordination of care, promoting 
effective prevention and treatment, and making care affordable.
    We also stated that we had evaluated the appropriateness and 
completeness of the HH QRP's current measure removal factors. In the CY 
2017 HH PPS final rule (81 FR 76754 through 76755), we noted that we 
had adopted a process for retaining, removing, and replacing previously 
adopted HH QRP measures. To be consistent with other established 
quality reporting programs, in the CY 2019 HH PPS proposed rule (83 FR 
32440 through 32441), we proposed to replace the six criteria used when 
considering a quality measure for removal, finalized in the CY 2017 HH 
PPS final rule (81 FR 76754 through 76755), with the following seven 
measure removal factors, finalized for the LTCH QRP in the FY 2013 
IPPS/LTCH PPS final rule (77 FR 53614 through 53615), for the SNF QRP 
in the FY 2016 SNF PPS final rule (80 FR 46431 through 46432), and for 
the IRF QRP in the CY 2013 OPPS/ASC final rule (77 FR 68502 through 
68503), for use in the HH QRP:
     Factor 1. Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made.
     Factor 2. Performance or improvement on a measure does not 
result in better patient outcomes.
     Factor 3. A measure does not align with current clinical 
guidelines or practice.
     Factor 4. A more broadly applicable measure (across 
settings, populations, or conditions) for the particular topic is 
available.
     Factor 5. A measure that is more proximal in time to 
desired patient outcomes for the particular topic is available.
     Factor 6. A measure that is more strongly associated with 
desired patient outcomes for the particular topic is available.
     Factor 7. Collection or public reporting of a measure 
leads to negative unintended consequences other than patient harm.
    As we stated in the proposed rule, we believe these measure removal 
factors are substantively consistent with the criteria we previously 
adopted (but noted that we would be changing the terminology to call 
them ``factors'') and appropriate for use in the HH QRP. However, we 
stated that even if one or more of the measure removal factors applies, 
we might nonetheless choose to retain the measure for certain specified 
reasons. We stated that examples of such instances could include when a 
particular measure addresses a gap in quality that is so significant 
that removing the measure could result in poor quality, or in the event 
that a given measure is statutorily required. Furthermore, we noted 
that consistent with other quality reporting programs, we would apply 
these factors on a case-by-case basis.
    We finalized in the CY 2017 HH PPS final rule (81 FR 76755) that 
removal of a HH QRP measure would take place through notice and comment 
rulemaking, unless we determined that a measure is causing concern for 
patient safety. Specifically, in the case of a HH QRP measure for which 
there is a reason to believe that the continued collection raised 
possible safety concerns, we stated that we would promptly remove the 
measure and publish the justification for the removal in the Federal 
Register during the next rulemaking cycle. In addition, we stated that 
we would immediately notify HHAs and the public through the usual 
communication channels, including listening sessions, memos, email 
notification, and Web postings. We stated that if we removed a measure 
from the HH QRP under these circumstances but also collected data on 
that measure under different statutory authority for a different 
purpose, we would notify stakeholders that we would also cease 
collecting the data under that alternative statutory authority.
    In the CY 2019 HH PPS proposed rule (83 FR 32440 through 32441), we 
also proposed to adopt an additional factor to consider when evaluating 
potential measures for removal from the HH QRP measure set:
     Factor 8. The costs associated with a measure outweigh the 
benefit of its continued use in the program.
    As we discussed in the CY 2019 HH PPS proposed rule (83 FR 32344 
through 32345, 32440 through 32441), with respect to our new Meaningful 
Measures Initiative, we are engaging in efforts to ensure that the HH 
QRP measure set continues to promote improved health outcomes for 
beneficiaries while minimizing the overall costs associated with the 
program. We stated our belief that these costs are multifaceted and 
include not only the burden associated with reporting, but also the 
costs associated with implementing and maintaining the program. We also 
stated that we had identified several different types of costs, 
including, but not limited to the following:
     Provider and clinician information collection burden and 
burden associated with the submitting/reporting of quality measures to 
CMS.
     The provider and clinician cost associated with complying 
with other HH programmatic requirements.
     The provider and clinician cost associated with 
participating in multiple quality programs, and tracking multiple 
similar or duplicative measures within or across those programs.
     The cost to CMS associated with the program oversight of 
the measure, including measure maintenance and public display.
     The provider and clinician cost associated with compliance 
with other federal and state regulations (if applicable).
    For example, we stated that it may be of limited benefit to retain 
or maintain a measure which our analyses show no longer meaningfully 
supports program objectives (for example, informing beneficiary 
choice). It may also be costly for HHAs to track confidential feedback, 
preview reports, and publicly reported information on a measure where 
we use the measure in more than one program. We may also have to expend 
resources to maintain the specifications for the measure, including the 
tools needed to collect, validate, analyze, and publicly report the 
measure data.
    When these costs outweigh the evidence supporting the continued use 
of a measure in the HH QRP, we stated our belief that it may be 
appropriate to remove the measure from the program. Although we 
recognize that one of the main goals of the HH QRP is to improve 
beneficiary outcomes by incentivizing health care providers to focus on 
specific care issues and making public data related to those issues, we 
also

[[Page 56550]]

recognize that those goals can have limited utility where, for example, 
the publicly reported data is of limited use because it cannot be 
easily interpreted by beneficiaries and used to influence their choice 
of providers. In these cases, removing the measure from the HH QRP may 
better accommodate the costs of program administration and compliance 
without sacrificing improved health outcomes and beneficiary choice.
    We proposed that we would remove measures based on Factor 8 on a 
case-by-case basis. For example, we may decide to retain a measure that 
is burdensome for HHAs to report if we conclude that the benefit to 
beneficiaries is so high that it justifies the reporting burden. We 
stated that our goal is to move the HH QRP program forward in the least 
burdensome manner possible, while maintaining a parsimonious set of 
meaningful quality measures and continuing to incentivize improvement 
in the quality of care provided to patients.
    We invited public comment on our proposals to replace the six 
criteria used when considering a quality measure for removal with the 
seven measure removal factors currently adopted in the LTCH QRP, IRF 
QRP, and SNF QRP. We also invited public comment on our proposal to 
adopt new measure removal Factor 8: The costs associated with a measure 
outweigh the benefit of its continued use in the program.
    Comment: The majority of commenters supported the proposal to 
replace the current six criteria with the seven factors to create 
alignment with the other PAC settings. The majority of commenters also 
supported the addition of Factor 8. A few commenters strongly agreed 
that quality measure reporting is important, but noted that the costs 
of such reporting can at times exceed the value of the data.
    Response: We thank these commenters for their support.
    Comment: With respect to Factor 1, a commenter noted support but 
added that automatically removing topped out measures creates a risk of 
decreased adherence to those evidence-based measures. The commenter 
urged CMS to consider continuing to require data reporting on topped 
out measures for a certain period time to ensure that performance in 
certain areas of quality, such as depression and fall risk, does not 
decline. Another commenter recommended that CMS periodically reassess 
any measure removed under Factor 1 to determine if there has been a 
decline in performance since the time the measure was removed.
    Response: We thank these commenter for their comments. We do not 
automatically remove topped out measures, and wish to reiterate that a 
topped out measure may be retained for specified reasons. We may retain 
a particular measure with high performance rates if the measure 
addresses a topic related to quality that is so significant that we do 
not want to risk a decline in quality that could result if we removed 
the measure, or if the measure addresses a topic that is statutorily 
required. In response to the commenters' concern about a decline in 
performance that could result if a measure is removed based on Factor 
1, we currently monitor for gaps in the quality of care related to the 
topic which a removed measure addressed, and we would consider whether 
to reintroduce a measure on that topic if we discovered such a gap.
    Comment: A commenter raised concerns about the rationale of 
removing relatively precise measures in favor of more broadly 
applicable ones, noting that broader applicability and reportability do 
not necessarily equate to better measures. This commenter recommended 
choosing measures on the basis of their clinical significance.
    Response: We agree that replacing a narrow measure with one that is 
more broadly applicable would be problematic if the more broadly 
applicable measure did not correlate with high quality outcomes. We 
intend to only consider measure replacement under Factor 4 if the more 
broadly applicable measure is at least comparable in terms of how well 
it addresses quality outcomes as the measure it is replacing.
    Comment: A commenter recommended that CMS change the wording of 
Factor 2 from ``Performance or improvement on a measure does not result 
in better patient outcomes'' to ``Performance or improvement on a 
measure is not associated with better patient outcomes'' so that the 
factor does not suggest that causality.
    Response: We thank the commenter for its suggestion. We believe 
that there is a direct correlation between performance improvement on a 
measure and better patient outcomes. We would apply Factor 2 when our 
data analysis indicates that, despite performance improvement on a 
measure, there is no improvement in patient outcomes.
    Comment: A few commenters expressed specific support for the 
adoption of the new measure removal Factor 8: The costs associated with 
a measure outweigh the benefit of its continued use in the program for 
the HH QRP. Other commenters noted that Factor 8 was consistent with 
CMS' Patients over Paperwork initiative.
    Response: We appreciate the support of the addition of this measure 
removal factor for the HH QRP.
    Comment: Another commenter recommended that Factor 8 be applied on 
a case-by-case basis, and another commenter recommended that CMS 
consider a variety of costs in Factor 8's application, including costs 
to providers and clinicians participating in multiple quality programs. 
Another commenter opposed the adoption of Factor 8, citing the 
difficulty of measuring benefits to patients when comparing costs and 
benefits.
    Response: We note that there are challenges in weighing the overall 
benefits for patients against the associated costs. We also recognize 
that various stakeholders may have different perspectives on such 
benefits and costs. In light of these challenges, we intend to evaluate 
each measure on a case-by-case basis, taking into account the input 
from a variety of stakeholders, including, but not limited to: 
Patients, caregivers, patient and family advocates, providers, provider 
associations, healthcare researchers, data vendors, and other 
stakeholders with insight into the benefits and costs (financial and 
otherwise) of maintaining the specific measure in the HH QRP. Because 
for each measure the relative benefit to each stakeholder may vary, we 
believe that the benefits to be evaluated for each measure are specific 
to the measure and the original rationale for including the measure in 
the program. Therefore, when evaluating whether a measure should be 
removed under Factor 8, we intend to assess and take into consideration 
issues including the holistic balance of the costs, benefits, data, 
input from stakeholders, and our policy objectives.
    Final Decision: After consideration of the public comments, we are 
finalizing our proposal to replace the six criteria used when 
considering a quality measure for removal with the seven measure 
removal factors currently adopted in other CMS programs, including LTCH 
QRP, IRF QRP, and SNF QRP. We are also finalizing our proposal to add 
to the HH QRP measure removal Factor 8: The costs associated with a 
measure outweigh the benefit of its continued use in the program.

D. Quality Measures Currently Adopted for the HH QRP

    The HH QRP currently has 30 \48\ measures for the CY 2020 program 
year, as outlined in Table 41.
---------------------------------------------------------------------------

    \48\ In the CY 2019 HH PPS proposed rule (83 FR 32441) we 
incorrectly stated that there are 31 measures for the CY 2020 
program year. The current Pressure Ulcer/Injury measure, Percent of 
Residents or Patients with Pressure Ulcers That Are New or Worsened 
(Short Stay) (NQF #0678), will be replaced by a modified version of 
that measure, Changes in Skin Integrity Post-Acute Care: Pressure 
Ulcer/Injury, effective January 1, 2019.

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[[Page 56551]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.074

E. Removal of HH QRP Measures Beginning With the CY 2021 HH QRP

    To address the Meaningful Measures Initiative discussed in the CY 
2019 HH PPS proposed rule in the CY 2019 HH PPS proposed rule (83 FR 
32442 through 32446) we proposed to remove seven measures from the HH 
QRP beginning with the CY 2021 HH QRP. We received a few general 
comments on the proposed removal of these measures.
    Comment: Most commenters, including MedPAC, supported CMS' proposal 
to remove all seven measures.

[[Page 56552]]

    Response: We thank the commenters for their support of all of our 
measure removal proposals.
    Comment: While supportive of the proposals to remove the seven 
measures, two commenters urged CMS to consider not waiting until the CY 
2021 HH QRP program year to remove them from the HH QRP. These 
commenters also noted that if CMS continues to collect data through the 
OASIS on process measures that have been removed from the HH QRP but 
still represent best practices, HHAs can continue to monitor their 
performance on those measures without being concerned about having to 
report them for the HH QRP.
    Response: We thank the commenters for their support of the measure 
removal proposals and note that we are finalizing all of them. We are 
unable to update the OASIS submission system before January 1, 2020, 
which is midway through the data collection period that we use for the 
HH QRP (see 81 FR 76783). As a result, with respect to the five HH QRP 
measures that are calculated using OASIS data (Depression Assessment 
Conducted, Diabetic Foot Care and Patient/Caregiver Education 
Implemented During All Episodes of Care, Multifactor Fall Risk 
Assessment Conducted For All Patients Who Can Ambulate (NQF #0537), 
Pneumococcal Polysaccharide Vaccine Ever Received, and Improvement in 
the Status of Surgical Wounds), HHAs will be required to continue 
submitting data on those measures with respect to home health quality 
episodes that begin during the first two quarters of the CY 2021 
program year (that is, for home health episodes that occur during the 
3rd and 4th quarters of CY 2019). With respect to the two HH QRP 
measures we are removing that are calculated using claims data 
(Emergency Department Use without Hospital Readmission During the First 
30 Days of HH (NQF #2505) and Rehospitalization During the First 30 
Days of HH (NQF #2380)), we will stop collecting claims data for the 
calculation of these two measures beginning with home health quality 
episodes that begin on or after July 1, 2019.
    We remind HHAs that the removal of a measure from the HH QRP does 
not prevent HHAs from continuing to incorporate the quality process 
addressed by that measure in their own quality monitoring activities, 
and we would encourage HHAs to do so.
1. Removal of the Depression Assessment Conducted Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32442), we proposed to 
remove the Depression Assessment Conducted Measure from the HH QRP 
beginning with the CY 2021 HH QRP under Factor 1: Measure performance 
among HHAs is so high and unvarying that meaningful distinctions in 
improvements in performance can no longer be made.
    In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we 
adopted the Depression Assessment Conducted Measure beginning with the 
CY 2010 HH QRP. Depression in the elderly is associated with 
disability, impaired well-being, service utilization,\49\ and 
mortality.\50\ This process measure reports the percentage of HH 
episodes in which patients were screened for depression (using a 
standardized depression screening tool) at start of care/resumption of 
care (SOC/ROC). The measure is calculated solely using the OASIS Item 
M1730, Depression Screening.\51\ Item M1730 is additionally used at 
SOC/ROC as a risk adjuster in the calculation of several other OASIS-
based outcome measures currently adopted for the HH QRP.\52\
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    \49\ Beekman AT, Deeg DJ, Braam AW, et al.: Consequences of 
major and minor depression in later life: a study of disability, 
well-being and service utilization. Psychological Medicine 27:1397-
1409, 1997.
    \50\ Schulz, R., Beach, S.R., Ives, D.G., Martire, L.M., Ariyo, 
A. A., & Kop, W.J. (2000). Association between depression and 
mortality in older adults--The Cardiovascular Health Study. Archives 
of Internal Medicine, 160(12), 1761-1768.
    \51\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
    \52\ The OASIS-based HH QRP outcome measures that use OASIS Item 
M1730 as a risk adjuster in the calculation of the measure are: 
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring 
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167), 
Improvement in Dyspnea, Improvement in Pain Interfering with 
Activity (NQF #0177), Improvement in Management of Oral Medications 
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF 
#0178).
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    We stated in the CY 2019 HH PPS proposed rule that in our 
evaluation of the Depression Assessment Conducted Measure, we found 
that HHA performance is very high and that meaningful distinctions in 
improvements in performance cannot be made. The mean and median agency 
performance scores for this measure in 2017 (96.8 percent and 99.2 
percent, respectively) when compared to the mean and median agency 
performance scores for this measure in 2010 (88.0 percent and 96.6 
percent, respectively) indicate that an overwhelming majority of 
patients are screened for depression in the HH setting. Further, these 
performance scores demonstrate the improvement in measure performance 
since its adoption in the HH QRP. In addition, in 2017 the 75th 
percentile measure score (100 percent) and the 90th percentile measure 
score (100 percent) are statistically indistinguishable from each 
other, meaning that the measure scores do not meaningfully distinguish 
scores between HHAs. Further, the Truncated Coefficient of Variation 
(TCV) \53\ for this measure is 0.03, suggesting that it is not useful 
to draw distinctions between individual agency performance scores for 
this measure.
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    \53\ The truncated coefficient of variation (TCV) is the ratio 
of the standard deviation to the mean of the distribution of all 
scores, excluding the 5 percent most extreme scores. A small TCV 
(<=0.1) indicates that the distribution of individual scores is 
clustered tightly around the mean value, suggesting that it is not 
useful to draw distinctions between individual performance scores.
---------------------------------------------------------------------------

    For these reasons, we proposed to remove the Depression Assessment 
Conducted Measure from the HH QRP beginning with the CY 2021 HH QRP 
under our Factor 1: Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made.
    We stated in the proposed rule that if we finalized this proposal, 
HHAs would no longer be required to submit OASIS Item M1730, Depression 
Screening at SOC/ROC for the purposes of this measure beginning January 
1, 2020. HHAs would, however, continue to submit data on M1730 at the 
time point of SOC/ROC as a risk adjuster for several other OASIS-based 
outcome measures currently adopted for the HH QRP.\54\ We also stated 
that if we finalized this proposal, data for this measure would be 
publicly reported on HH Compare until January 2021.
---------------------------------------------------------------------------

    \54\ The OASIS-based HH QRP outcome measures that use OASIS Item 
M1730 as a risk adjuster in the calculation of the measure are: 
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring 
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167), 
Improvement in Dyspnea, Improvement in Pain Interfering with 
Activity (NQF #0177), Improvement in Management of Oral Medications 
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF 
#0178).
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    We invited public comment on this proposal.
    Comment: A commenter expressed general support for the removal of 
the Depression Assessment Conducted measure but encouraged CMS to 
consider how else mood could be assessed in the HH setting, noting that 
behavioral health is a key aspect of patient outcomes.
    Response: We agree that behavioral health is a key aspect of 
patient outcomes and wish to clarify that the

[[Page 56553]]

removal of this measure would not eliminate mood assessment in the HH 
setting. HHAs will continue to report OASIS Item M1730, Depression 
Screening at the time point of SOC/ROC as part of their reporting of 
data for other OASIS-based outcome measures currently used in the HH 
QRP. In addition, we continue to develop and test standardized patient 
assessment data elements that, if adopted, would assess the cognitive 
function and mental status of patients in PAC settings.\55\
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    \55\ Development and Maintenance of Standardized Cross Setting 
Patient Assessment Data for Post-Acute Care: Summary Report of 
Findings from Alpha 2 Pilot Testing. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Alpha-2-SPADE-Pilot-Summary-Document.pdf.
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    Final Decision: After considering public comment, we are finalizing 
our proposal to remove the Depression Assessment Conducted Measure from 
the HH QRP. HHAs will no longer be required to submit OASIS Item M1730, 
Depression Screening at SOC/ROC for the purposes of this measure 
beginning with Home Health quality episodes of care that begin on or 
after January 1, 2020. HHAs will, however, continue to submit data on 
M1730 at the time point of SOC/ROC as a risk adjuster for several other 
OASIS-based outcome measures currently adopted for the HH QRP. Data for 
this measure will be publicly reported until such data are no longer 
available for public reporting of this measure on HH Compare.
2. Removal of the Diabetic Foot Care and Patient/Caregiver Education 
Implemented During All Episodes of Care Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32442 through 32443), we 
proposed to remove the Diabetic Foot Care and Patient/Caregiver 
Education Implemented during All Episodes of Care Measure from the HH 
QRP beginning with the CY 2021 HH QRP under our proposed Factor 1: 
Measure performance among HHAs is so high and unvarying that meaningful 
distinctions in improvements in performance can no longer be made.
    In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we 
adopted the Diabetic Foot Care and Patient/Caregiver Education 
Implemented during All Episodes of Care Measure beginning with the CY 
2010 HH QRP. This process measure reports the percentage of HH quality 
episodes in which diabetic foot care and patient/caregiver education 
were included in the physician-ordered plan of care and implemented (at 
the time of or at any time since the most recent SOC/ROC assessment). 
The measure numerator is calculated using OASIS Item M2401 row a, 
Intervention Synopsis: Diabetic foot care.\56\
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    \56\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------

    We stated in the CY 2019 HH PPS proposed rule (83 FR 32443) that in 
our evaluation of the Diabetic Foot Care and Patient/Caregiver 
Education Implemented during All Episodes of Care Measure, we found 
that HHA performance is very high and that meaningful distinctions in 
improvements in performance cannot be made. The mean and median agency 
performance scores for this measure in 2017 (97.0 percent and 99.2 
percent, respectively) when compared to the mean and median agency 
performance score for this measure in 2010 (86.2 percent and 91.7 
percent, respectively), indicate that an overwhelming majority of HH 
episodes for patients with diabetes included education on foot care. 
Further, these scores demonstrate the improvement in measure 
performance since the Diabetic Foot Care and Patient/Caregiver 
Education Implemented during All Episodes of Care Measure's adoption in 
the HH QRP. In addition, in 2017, the 75th percentile measure score 
(100 percent) and the 90th percentile score (100 percent) are 
statistically indistinguishable from each other, meaning that the 
measure scores do not meaningfully distinguish between HHAs. Further, 
the TCV for this measure is 0.03, suggesting that it is not useful to 
draw distinctions between individual agency performance scores for this 
measure.
    For these reasons, we proposed to remove the Diabetic Foot Care and 
Patient/Caregiver Education Implemented during All Episodes of Care 
Measure from the HH QRP beginning with CY 2021 HH QRP under our 
proposed Factor 1: Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made.
    We stated in the proposed rule that if we finalized this proposal, 
HHAs would no longer be required to submit OASIS Item M2401 row a, 
Intervention Synopsis: Diabetic foot care at the time point of Transfer 
to an Inpatient Facility (TOC) and Discharge from Agency--Not to an 
Inpatient Facility (Discharge) for the purposes of the HH QRP beginning 
January 1, 2020. HHAs may enter an equal sign (=) for M2401, row a, at 
the time point of TOC and Discharge on or after January 1, 2020. We 
also stated that if we finalized this proposal, data for this measure 
would be publicly reported on HH Compare until January 2021.
    We invited public comment on this proposal.
    Comment: Another commenter expressed general support for the 
removal of the Diabetic Foot Care and Patient/Caregiver Education 
Implemented during All Episodes of Care Measure, but encouraged CMS to 
provide clear updates to providers about how they should complete items 
until the next OASIS version is released.
    Response: We thank the commenter for its support. We intend to 
provide further guidance and training on how to properly complete the 
OASIS.
    Final Decision: After considering public comment, we are finalizing 
our proposal to remove the Diabetic Foot Care and Patient/Caregiver 
Education Implemented during All Episodes of Care Measure from the HH 
QRP. HHAs will no longer be required to submit OASIS Item M2401 row a, 
Intervention Synopsis: Diabetic foot care at the time point of Transfer 
to an Inpatient Facility (TOC) and Discharge from Agency--Not to an 
Inpatient Facility (Discharge) for the purposes of the HH QRP beginning 
January 1, 2020. HHAs may enter an equal sign (=) for M2401, row a, at 
the time point of TOC and Discharge on or after January 1, 2020. Data 
for this measure will be publicly reported until such data are no 
longer available for public reporting of this measure on HH Compare.
3. Removal of the Multifactor Fall Risk Assessment Conducted for All 
Patients Who Can Ambulate (NQF #0537) Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32443), we proposed to 
remove the Multifactor Fall Risk Assessment Conducted For All Patients 
Who Can Ambulate (NQF #0537) Measure from the HH QRP beginning with the 
CY 2021 HH QRP, under our proposed Factor 1: Measure performance among 
HHAs is so high and unvarying that meaningful distinctions in 
improvements in performance can no longer be made.
    In CY 2010 HH PPS final rule (74 FR 58096 through 58098), we 
adopted the Multifactor Fall Risk Assessment Conducted For All Patients 
Who Can Ambulate (NQF #0537) Measure \57\

[[Page 56554]]

beginning with the CY 2010 HH QRP. This process measure reports the 
percentage of HH quality episodes in which patients had a multifactor 
fall risk assessment at SOC/ROC. The measure is calculated using OASIS 
Item M1910, Falls Risk Assessment.\58\
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    \57\ At the time, this measure was adopted as ``Falls risk 
assessment for patients 65 and older.'' The name of this measure was 
updated in the CY 2018 HH PPS final rule (82 FR 51717).
    \58\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------

    We stated in the proposed rule (83 FR 32443) that in our evaluation 
of the Multifactor Fall Risk Assessment Conducted For All Patients Who 
Can Ambulate (NQF #0537) Measure, we found that HHA performance is very 
high and that meaningful distinctions in improvements in performance 
cannot be made. The mean and median agency performance scores for this 
measure in 2017 (99.3 percent and 100.0 percent, respectively) when 
compared to the mean and median agency performance score for this 
measure in 2010 (94.8 percent and 98.9 percent, respectively), indicate 
that an overwhelming majority of patients in an HHA have had a 
multifactor fall risk assessment at SOC/ROC and demonstrates the 
improvement in measure performance since its adoption. In addition, in 
2017, the 75th percentile measure score (100 percent) and the 90th 
percentile measure score (100 percent) are statistically 
indistinguishable from each other, meaning that the measure scores do 
not meaningfully distinguish between HHAs. Further, the TCV for this 
measure is 0.01, suggesting that it is not useful to draw distinctions 
between individual agency performance scores for this measure.
    For these reasons, we proposed to remove the Multifactor Fall Risk 
Assessment Conducted For All Patients Who Can Ambulate (NQF #0537) 
Measure from the HH QRP beginning with the CY 2021 HH QRP, under our 
proposed Factor 1: Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made.
    We stated in the proposed rule that if we finalized this proposal, 
HHAs would no longer be required to submit OASIS Item M1910, Falls Risk 
Assessment at SOC/ROC beginning January 1, 2020. HHAs may enter an 
equal sign (=) for M1910 at the time point of SOC and ROC beginning 
January 1, 2020. We also stated that if we finalized this proposal, 
data for this measure would be publicly reported on HH Compare until 
January 2021.
    We invited public comment on this proposal.
    Comment: Another commenter expressed general support for the 
removal of the Multifactor Fall Risk Assessment Conducted For All 
Patients Who Can Ambulate (NQF #0537) Measure, but encouraged CMS to 
consider whether it is appropriate to adopt measures when performance 
is high initially.
    Response: We thank the commenter for its support. We agree that it 
is important to evaluate whether the measure rates on a measure being 
considered for adoption are already high because that analysis bears on 
the question of whether the measure is needed to address a gap in 
quality. However, we wish to note that there may be quality measures 
that address an important Meaningful Measure Area in which most 
providers will likely perform well. Examples of such measures include 
those that take into account ``never events,'' such as falls with major 
injury, or topics such as potentially preventable readmissions. In 
these instances, such performance information remains useful to 
consumers and providers even if the measure performance is high 
initially.
    Final Decision: After considering public comment, we are finalizing 
our proposal to remove the Multifactor Fall Risk Assessment Conducted 
For All Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP. 
HHAs will no longer be required to submit OASIS Item M1910, Falls Risk 
Assessment at SOC/ROC beginning January 1, 2020. HHAs may enter an 
equal sign (=) for M1910 at the time point of SOC and ROC beginning 
January 1, 2020. Data for this measure will be publicly reported until 
such data are no longer available for public reporting of this measure 
on HH Compare.
4. Removal of the Pneumococcal Polysaccharide Vaccine Ever Received 
Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32443 through 32444), we 
proposed to remove the Pneumococcal Polysaccharide Vaccine (PPV) Ever 
Received Measure from the HH QRP beginning with the CY 2021 HH QRP, 
under our proposed Factor 3: A measure does not align with current 
clinical guidelines or practice.
    In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we 
adopted the Pneumococcal Polysaccharide Vaccine Ever Received Measure 
beginning with CY 2010 HH QRP. This process measure reports the 
percentage of HH quality episodes during which patients were determined 
to have ever received the Pneumococcal Polysaccharide Vaccine. The 
measure is calculated using OASIS Items M1051, Pneumococcal Vaccine and 
M1056, Reason Pneumococcal Vaccine not received.\59\
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    \59\ 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-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------

    At the time that this measure was adopted in the HH QRP, the 
Advisory Committee on Immunization Practices (ACIP),\60\ which sets 
current clinical guidelines, recommended use of a single dose of the 
23-valent pneumococcal polysaccharide vaccine (PPSV23) among all adults 
aged 65 years and older and those adults aged 19 to 64 years with 
underlying medical conditions that put them at greater risk for serious 
pneumococcal infection.\61\
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    \60\ The Advisory Committee on Immunization Practices was 
established under section 222 of the Public Health Service Act (42 
U.S.C. 217a), as amended, to assist states and their political 
subdivisions in the prevention and control of communicable diseases; 
to advise the states on matters relating to the preservation and 
improvement of the public's health; and to make grants to states 
and, in consultation with the state health authorities, to agencies 
and political subdivisions of states to assist in meeting the costs 
of communicable disease control programs. (Charter of the Advisory 
Committee on Immunization Practices, filed April 1, 2018 (https://www.cdc.gov/vaccines/acip/committee/ACIP-Charter-2018.pdf).
    \61\ Prevention of Pneumococcal Disease: Recommendations of the 
Advisory Committee on Immunization Practices (ACIP), MMWR 1997;46:1-
24.
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    Since this measure was added to the HH QRP, the ACIP has updated 
its pneumococcal vaccination recommendations.\62\ Two pneumococcal 
vaccines are currently licensed for use in the United States: The 13-
valent pneumococcal conjugate vaccine (PCV13) and the 23-valent 
pneumococcal vaccine (PPSV23). The ACIP currently recommends that both 
PCV13 and PPSV23 be given to all immunocompetent adults aged >=65 
years. The recommended intervals for sequential administration of PCV13 
and PPSV23 depend on several patient factors including: The current age 
of the adult, whether the adult had previously received PPSV23, and the 
age of the adult at the time of prior PPSV23 vaccination (if 
applicable).
---------------------------------------------------------------------------

    \62\ Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent 
pneumococcal conjugate vaccine and 23-valent pneumococcal 
polysaccharide vaccine among adults aged >=65 years: recommendations 
of the Advisory Committee on Immunization Practices (ACIP). MMWR 
2014;63: 822-5.

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[[Page 56555]]

    We stated in the proposed rule that the specifications for the 
Pneumococcal Polysaccharide Vaccine Ever Received Measure do not fully 
reflect the current ACIP guidelines. Therefore, we believe that the 
Pneumococcal Polysaccharide Vaccine Ever Received Measure no longer 
aligns with the current clinical guidelines or practice. For this 
reason, we proposed to remove the Pneumococcal Polysaccharide Vaccine 
Ever Received Measure from the HH QRP beginning with the CY 2021 HH QRP 
under our proposed Factor 3: A measure does not align with current 
clinical guidelines or practice.
    We stated in the proposed rule (83 FR 32444) that if we finalized 
this proposal, HHAs would no longer be required to submit OASIS Items 
M1051, Pneumococcal Vaccine and M1056, Reason Pneumococcal Vaccine not 
received at the time point of TOC and Discharge for the purposes of the 
HH QRP beginning January 1, 2020. HHAs may enter an equal sign (=) for 
Items M1051 and M1056 at the time point of TOC and Discharge on or 
after January 1, 2020. We also stated that if we finalized this 
proposal, data for this measure would be publicly reported on HH 
Compare until January 2021.
    We invited public comment on this proposal.
    Comment: A few commenters supported the measure removal because it 
does not reflect current Advisory Committee on Immunization Practices 
(ACIP) guidelines.
    Response: We thank the commenters for their support.
    Comment: A few commenters did not support the removal of the PPV 
measure from the HH QRP, citing concerns with patient care consequences 
that could occur as a result of its removal. Some of these commenters 
noted that HHAs play a valuable role in providing immunizations to 
home-bound patients who experience barriers to vaccination access. 
Another commenter recommended retaining the current PPV measure until 
it is updated to reflect the most recent ACIP guidelines for both 
pneumococcal vaccinations, adding that its removal may be confusing to 
HHAs and may also lead to reductions in pneumococcal immunization 
rates. This commenter stated that the measure is aligned with 
Meaningful Measures objectives on addressing high-impact and patient-
centered measure areas, and that retaining the measure would not be 
burdensome to HHAs, given their ability to establish standing orders to 
support immunization processes.
    Response: While we understand that assessing and appropriately 
vaccinating patients are important components of the care process, we 
also prioritize ensuring that quality measures can used by 
practitioners to inform their clinical decision and care planning 
activities. The updated ACIP pneumococcal vaccination recommendations 
require information that is often not available to HHAs, including 
whether the patient has previously been vaccinated, the type of 
pneumococcal vaccine received by the patient, and the sequencing of 
vaccine administration. In addition, the physician who is responsible 
for the home health plan of care may not be the patient's primary care 
practitioner or other health care professional responsible for 
providing care and services to the patient before and after discharge 
from the HHA, and therefore may not be best able to provide the HHA 
with such information. Also, even if the pneumococcal vaccination 
status of the patient is available, OASIS Items M1051, Pneumococcal 
Vaccine and M1056, Reason Pneumococcal Vaccine not received, both of 
which are used in the calculation of this measure, do not correspond to 
the updated ACIP pneumococcal vaccination recommendations and therefore 
may not accurately measure HHA performance in this area. However, we 
understand and value the role pneumococcal vaccines play in preventing 
pneumococcal disease \63\ and we encourage that, whenever possible and 
as appropriate, HHAs provide pneumococcal vaccinations to their 
patients.
---------------------------------------------------------------------------

    \63\ CDC: Pneumococcal Disease. Retrieved from: http://www.cdc.gov/pneumococcal/about/prevention.html.
---------------------------------------------------------------------------

    Comment: A few commenters recommended that CMS consider using an 
alternative pneumococcal measure, Pneumonia Vaccination Status for 
Older Adults (NQF #0043).
    Response: The specifications for the Pneumococcal Vaccination 
Status for Older Adults measure also do not fully reflect the current 
ACIP guidelines. Therefore, this measure would not be an appropriate 
measure to consider for adoption into the HH QRP.
    Final Decision: After considering public comment, we are finalizing 
our proposal to remove the Pneumococcal Polysaccharide Vaccine Ever 
Received Measure from the HH QRP. HHAs will no longer be required to 
submit OASIS Items M1051, Pneumococcal Vaccine and M1056, Reason 
Pneumococcal Vaccine not received at the time point of TOC and 
Discharge for the purposes of the HH QRP beginning January 1, 2020. 
HHAs may enter an equal sign (=) for Items M1051 and M1056 at the time 
point of TOC and Discharge on or after January 1, 2020. Data for this 
measure will be publicly reported until such data are no longer 
available for public reporting of this measure on HH Compare.
5. Removal of the Improvement in the Status of Surgical Wounds Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32444 through 32445), we 
proposed to remove the Improvement in the Status of Surgical Wounds 
Measure from the HH QRP beginning with the CY 2021 HH QRP under our 
proposed Factor 4: A more broadly applicable measure (across settings, 
populations, or conditions) for the particular topic is available.
    In the CY 2008 HH PPS final rule (72 FR 49861 through 49863), we 
adopted the Improvement in the Status of Surgical Wounds Measure for 
the HH QRP beginning with the CY 2008 program year. This risk-adjusted 
outcome measure reports the percentage of HH episodes of care during 
which the patient demonstrates an improvement in the condition of skin 
integrity related to the surgical wounds. This measure is solely 
calculated using OASIS Items M1340, Does this patient have a Surgical 
Wound? and M1342, Status of Most Problematic Surgical Wound that is 
Observable.\64\ Items M1340 and M1342 are also used at the time points 
of SOC/ROC as risk adjusters in the calculation of several other OASIS-
based outcome measures currently adopted for the HH QRP.\65\ 
Additionally, Items M1340 and M1342 are used at the time point of 
Discharge for the Potentially Avoidable Events measure Discharged to 
the Community Needing Wound Care or Medication Assistance that is used 
by HH surveyors during the survey process.\66\
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    \64\ Measure specifications can be found in the Home Health 
Outcomes 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-C2_4-11-18.pdf).
    \65\ The OASIS-based HH QRP outcome measures that use OASIS 
Items M1340 and M1342 as a risk adjuster in the calculation of the 
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed 
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF 
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with 
Activity (NQF #0177), and Improvement in Management of Oral 
Medications (NQF #0176).
    \66\ Measure specifications can be found in the Home Health 
Potentially Avoidable Events Measures Table on the Home Health 
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
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    We stated in the proposed rule (83 FR 32444) that the Improvement 
in the

[[Page 56556]]

Status of Surgical Wounds Measure is limited in scope to surgical 
wounds incurred by surgical patients and excludes HH episodes of care 
where the patient, at SOC/ROC, did not have any surgical wounds or had 
only a surgical wound that was unobservable or fully epithelialized. As 
a result, the majority of HHAs are not able to report data on the 
measure and the measure is limited in its ability to compare how well 
HHAs address skin integrity. For example, in 2016, only 13 percent of 
HH patients had a surgical wound at the beginning of their HH episode 
and only 36.6 percent of HHAs were able to report data on the measure 
with respect to that year.
    In contrast, the Percent of Residents or Patients with Pressure 
Ulcers That Are New or Worsened (Short Stay) Measure (NQF #0678) \67\ 
and its replacement measure, Changes in Skin Integrity Post-Acute Care: 
Pressure Ulcer/Injury Measure, more broadly assess the quality of care 
furnished by HHAs with respect to skin integrity. These measures 
encourage clinicians to assess skin integrity in the prevention of 
pressure ulcers, as well as to monitor and promote healing in all HH 
patients, not just those with surgical wounds.
---------------------------------------------------------------------------

    \67\ To be replaced with a modified version of that measure, 
Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury, 
beginning with the CY 2020 HH QRP.
---------------------------------------------------------------------------

    Therefore, we proposed to remove the Improvement in the Status of 
Surgical Wounds Measure from the HH QRP beginning with the CY 2021 HH 
QRP under our proposed Factor 4: A more broadly applicable measure 
(across settings, populations, or conditions) for the particular topic 
is available.
    We stated in the proposed rule that if we finalized this proposal, 
HHAs would no longer be required to submit OASIS Items M1340, Does this 
patient have a Surgical Wound and M1342, Status of Most Problematic 
Surgical Wound that is Observable, at the time points of SOC/ROC and 
Discharge for the purposes of this measure beginning with January 1, 
2020 episodes of care. However, HHAs would still be required to submit 
data on Items M1340 and M1342 at the time point of SOC/ROC as risk 
adjusters for several other OASIS-based outcome measures currently 
adopted for the HH QRP,\68\ and also at the time point of Discharge for 
the Potentially Avoidable Events measure Discharged to the Community 
Needing Wound Care or Medication Assistance \69\ that is used by HH 
surveyors during the survey process. We also stated that if we 
finalized this proposal, data on this measure would be publicly 
reported on HH Compare until January 2021.
---------------------------------------------------------------------------

    \68\ The OASIS-based HH QRP outcome measures that use OASIS 
Items M1340 and M1342 as a risk adjuster in the calculation of the 
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed 
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF 
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with 
Activity (NQF #0177), and Improvement in Management of Oral 
Medications (NQF #0176).
    \69\ Measure specifications can be found in the Home Health 
Potentially Avoidable Events Measures Table on the Home Health 
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
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    We invited public comment on this proposal.
    Comment: A commenter supported removal of the Improvement in the 
Status of Surgical Wounds Measure, while encouraging CMS to monitor 
other skin integrity measures to ensure that the full range of patient 
skin integrity issues is captured. Another commenter opposed the 
removal of this measure, but did not clarify the reason.
    Response: We thank the commenters for their feedback. We will 
continue to closely monitor the performance data of other skin 
integrity measures.
    Final Decision: After considering public comment, we are finalizing 
our proposal to remove the Improvement in the Status of Surgical Wounds 
Measure from the HH QRP. HHAs will no longer be required to submit 
OASIS Items M1340, Does this patient have a Surgical Wound? and M1342, 
Status of Most Problematic Surgical Wound that is Observable, at the 
time points of SOC/ROC and Discharge for the purposes of this measure 
beginning January 1, 2020. However, HHAs will still be required to 
submit data on Items M1340 and M1342 at the time point of SOC/ROC as 
risk adjusters for several other OASIS-based outcome measures currently 
adopted for the HH QRP and also at the time point of Discharge for the 
Potentially Avoidable Events measure Discharged to the Community 
Needing Wound Care or Medication Assistance that is used by HH 
surveyors during the survey process. Data for this measure will be 
publicly reported until such data are no longer available for public 
reporting of this measure on HH Compare.
6. Removal of the Emergency Department Use Without Hospital Readmission 
During the First 30 Days of HH (NQF #2505) Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32445), we proposed to 
remove the Emergency Department (ED) Use without Hospital Readmission 
during the First 30 Days of HH (NQF #2505) Measure from the HH QRP 
beginning with the CY 2021 HH QRP, under our proposed Factor 4: A more 
broadly applicable measure (across settings, populations, or 
conditions) for the particular topic is available.
    In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we 
adopted the claims-based ED Use without Hospital Readmission during the 
first 30 days of HH (NQF #2505) Measure beginning with CY 2014 HH QRP. 
The particular topic for this measure is ED utilization, as it 
estimates the risk-standardized rate of ED use without acute care 
hospital admission during the 30 days following the start of the HH 
stay for patients with an acute inpatient hospitalization in the 5 days 
before the start of their HH stay. The ED Use without Hospital 
Readmission during the First 30 Days of HH (NQF #2505) Measure is 
limited to Medicare FFS patients with a prior, proximal inpatient stay. 
Recent analyses from 2016 and 2017 show that this measure annually 
captured approximately 2.5 million (25.1 percent in 2016 and 25.1 
percent in 2017) of Medicare FFS HH stays and was reportable for less 
than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent in 
2017).
    We stated in the proposed rule (83 FR 32444) that the ED Use 
without Hospitalization During the First 60 Days of HH (NQF #0173) 
Measure also addresses the topic of ED utilization during a HH stay. 
This measure reports the percentage of Medicare FFS HH stays in which 
patients used the ED but were not admitted to the hospital during the 
60 days following the start of the HH stay. The ED Use without 
Hospitalization during the First 60 days of HH (NQF #0173) Measure 
includes Medicare FFS patients irrespective of whether or not they had 
an acute inpatient hospitalization in the 5 days prior to the start of 
the HH stay and spans the first 60 days of a HH episode. Recent 
analyses using 2016 and 2017 data show this measure annually captures 
approximately 8.3 million stays (81.9 percent in 2016 and 81.8 percent 
in 2017) and is reportable by a greater number of HHAs (88.8 percent in 
2016 and 88.1 percent in 2017) than the ED Use without Hospital 
Readmission During the First 30 Days of HH (NQF #2505) Measure.
    We stated in the proposed rule (83 FR 32445) that the ED Use 
without Hospital Readmission During the First 30 Days of HH (NQF #2505) 
Measure addresses outcomes of Medicare FFS patients for a 30-day 
interval after the start of their HH care, regardless of the length of 
their HH stay. The more broadly applicable ED Use without 
Hospitalization during the First 60 days of HH (NQF #0173)

[[Page 56557]]

Measure addresses these same outcomes for a greater number of Medicare 
FFS patients during the first 60 days of a HH stay and includes the 30-
day interval of the ED Use without Hospital Readmission During the 
First 30 Days of HH (NQF #2505) Measure. The measure specifications for 
both measures are otherwise harmonized along several measure 
dimensions, including data source, population, denominator exclusions, 
numerator, and risk adjustment methodology. As a result, removing the 
ED Use without Hospital Readmission During the First 30 Days of HH (NQF 
#2505) Measure in favor of the ED Use without Hospitalization during 
the First 60 days of HH (NQF #0173) Measure will not result in a loss 
of the ability to measure the topic of ED utilization for HH patients.
    For these reasons, we proposed to remove the ED Use without 
Hospital Readmission During the First 30 Days of HH (NQF #2505) Measure 
from the HH QRP beginning with the CY 2021 HH QRP under our proposed 
Factor 4: A more broadly applicable measure (across settings, 
populations, or conditions) for the particular topic is available. We 
stated in the proposed rule that if we finalized this proposal, data 
for this measure would be reported on HH Compare until January 2020.
    We invited public comment on this proposal.
    Comment: A commenter supported the removal of this measure and 
expressed appreciation that CMS identified measures for removal in 
favor of more widely applicable ones.
    Response: We thank the commenter for its support.
    Final Decision: After considering public comment, we are finalizing 
our proposal as proposed to remove the Emergency Department (ED) Use 
without Hospital Readmission during the First 30 Days of HH (NQF #2505) 
Measure from the HH QRP beginning with the CY 2021 HH QRP. Data for 
this measure will be publicly reported until such data are no longer 
available for public reporting of this measure on HH Compare.
7. Removal of the Rehospitalization During the First 30 Days of HH (NQF 
#2380) Measure
    In the CY 2019 HH PPS proposed rule (83 FR 32445 through 32446), we 
proposed to remove the Rehospitalization during the First 30 Days of HH 
(NQF #2380) Measure from the HH QRP beginning with the CY 2021 HH QRP, 
under our proposed Factor 4: A more broadly applicable measure (across 
settings, populations, or conditions) for the particular topic is 
available.
    In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we 
adopted the claims-based Rehospitalization during the first 30 Days of 
HH Measure beginning with the CY 2014 HH QRP. The measure was NQF-
endorsed (NQF #2380) in December 2014. The Rehospitalization during the 
first 30 Days of HH (NQF #2380) Measure addresses the particular topic 
of acute care hospital utilization during a HH stay. This measure 
estimates the risk-standardized rate of unplanned, all-cause hospital 
readmissions for patients who had an acute inpatient hospitalization in 
the 5 days before the start of their HH stay and were admitted to an 
acute care hospital during the 30 days following the start of the HH 
stay (78 FR 72297 through 72301). The Rehospitalization During the 
First 30 Days of HH (NQF #2380) Measure only includes Medicare FFS 
patients. Recent analyses from 2016 and 2017 show that this measure 
annually captured approximately 2.5 million (25.1 percent in 2016 and 
25.1 percent in 2017) of Medicare FFS HH stays and was reportable for 
less than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent 
in 2017).
    In the CY 2013 HH PPS final rule (77 FR 67093 through 67094), we 
finalized the claims-based Acute Care Hospitalization Measure. The 
measure's title was later updated to Acute Care Hospitalization During 
the First 60 Days of HH (NQF #0171) to improve clarity.\70\ The Acute 
Care Hospitalization During the First 60 Days of HH (NQF #0171) Measure 
also addresses the topic of acute care hospital utilization during a HH 
stay. This measure reports the percentage of HH stays in which Medicare 
FFS patients were admitted to an acute care hospital during the 60 days 
following the start of the HH stay. The Acute Care Hospitalization 
during the First 60 Days of HH (NQF #0171) Measure includes Medicare 
FFS patients irrespective of whether or not they had an acute inpatient 
hospitalization in the 5 days prior to the start of the HH stay and 
spans the first 60 days of a HH episode. Recent analyses using 2016 and 
2017 data show this measure annually captures approximately 8.3 million 
stays (81.9 percent in 2016 and 81.8 percent in 2017) and is reportable 
by a greater number of HHAs (88.8 percent in 2016 and 88.1 percent in 
2017) than the Rehospitalization during the First 30 Days of HH (NQF 
#2380) Measure.
---------------------------------------------------------------------------

    \70\ All-Cause Admissions and Readmissions 2015-2017 Technical 
Report, National Quality Forum, Washington DC, 2017. (http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=85033) page 20.
---------------------------------------------------------------------------

    We stated in the proposed rule (83 FR 32446) that the 
Rehospitalization during the First 30 Days of HH (NQF #2380) Measure 
addresses outcomes of Medicare FFS patients for a 30-day interval after 
the start of their HH care, regardless of the length of their HH stay. 
In contrast, the Acute Care Hospitalization During the First 60 Days of 
HH (NQF #0171) Measure is broader because it addresses these same 
outcomes for a greater number of Medicare FFS patients during the first 
60 Days of a HH stay, which includes the 30-day interval of the 
Rehospitalization during the First 30 Days of HH (NQF #2380) Measure. 
The measure specifications for both measures are otherwise harmonized 
along several measure dimensions, including data source, population, 
denominator exclusions, numerator, and risk adjustment methodology. As 
a result, removing the Rehospitalization during the First 30 Days of HH 
(NQF #2380) Measure in favor of the Acute Care Hospitalization during 
the First 60 Days of HH (NQF #0171) Measure will not result in a loss 
of the ability to measure the topic of acute care hospital utilization 
across the HH setting.
    For these reasons, we proposed to remove the Rehospitalization 
during the First 30 Days of HH (NQF #2380) Measure from the HH QRP 
beginning with the CY 2021 HH QRP under our proposed Factor 4: A more 
broadly applicable measure (across settings, populations, or 
conditions) for particular topic is available. We stated in the 
proposed rule that if we finalized this proposal, data for this measure 
would be publicly reported on HH Compare until January 2020.
    We invited public comment on this proposal.
    Comment: A commenter supported the removal of this measure and 
expressed appreciation that CMS identified measures for removal in 
favor of more widely applicable ones.
    Response: We thank the commenter for its support.
    Final Decision: After considering public comment, we are finalizing 
our proposal as proposed to remove the Rehospitalization during the 
First 30 Days of HH (NQF #2380) Measure from the HH QRP beginning with 
the CY 2021 HH QRP. Data for this measure will be publicly reported on 
HH Compare until January 2020.

F. IMPACT Act Implementation Update

    In the CY 2018 HH PPS final rule (82 FR 51731), we stated that we 
intended to specify two measures that will satisfy

[[Page 56558]]

the domain of accurately communicating the existence and provision of 
the transfer of health information and care preferences under section 
1899B(c)(1)(E) of the Act no later than January 1, 2019 and intended to 
propose to adopt them for the CY 2021 HH QRP, with data collection 
beginning on or about January 1, 2020.
    We stated in the proposed rule that as a result of the input 
provided during a public comment period between November 10, 2016 and 
December 11, 2016, input provided by a technical expert panel (TEP) 
convened by our contractor, and pilot measure testing conducted in 
2017, we are engaging in continued development work on these two 
measures, including supplementary measure testing and providing the 
public with an opportunity for comment in 2018. Further, we reconvened 
a TEP for these measures in April 2018. We now intend to specify the 
measures under section 1899B(c)(1)(E) of the Act no later than January 
1, 2020, and intend to proposed to adopt the measures beginning with 
the CY 2022 HH QRP, with data collection at the time point of SOC, ROC 
and Discharge beginning with January 1, 2021. For more information on 
the pilot testing, we refer readers to: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Comment: A commenter supported the continued development of 
measures to satisfy the IMPACT Act domain of transfer of health 
information and care preferences, noting its belief that these measures 
will improve continuity of care and care transitions. Another commenter 
did not express support or opposition, but encouraged CMS to consider 
data collection burden across settings prior to adopting cross-setting 
measures that satisfy the requirements of the IMPACT Act.
    Response: We thank the commenters for their feedback.

G. Form, Manner, and Timing of OASIS Data Submission

    Our home health regulations, codified at Sec.  484.250(a), require 
HHAs to submit OASIS assessments and Home Health Care Consumer 
Assessment of Healthcare Providers and Systems Survey[supreg] (HHCAHPS) 
data to meet the quality reporting requirements of section 
1895(b)(3)(B)(v) of the Act. In the CY 2019 HH PPS proposed rule (83 FR 
32446), we proposed to revise Sec.  484.250(a) to clarify that not all 
OASIS data described in Sec.  484.55(b) and (d) are needed for purposes 
of complying with the requirements of the HH QRP. OASIS data items may 
be submitted for other established purposes unrelated to the HH QRP, 
including payment, survey, 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 HH QRP compliance.
    We invited public comment on our proposal to revise our regulations 
at Sec.  484.250(a) to clarify that not all OASIS data described in 
Sec.  484.55(b) and (d) are needed for purposes of complying with the 
requirements of the HH QRP.
    Comment: A commenter supported all proposed changes to the HH QRP, 
including updated regulations clarifying OASIS data collection 
requirements. Another commenter noted that the clarification confirms 
its understanding of the regulations.
    Response: We thank the commenters for their support.
    Final Decision: After considering public comment, we are finalizing 
our proposal as proposed to revise our regulations at Sec.  484.250(a) 
to clarify that not all OASIS data described in Sec.  484.55(b) and (d) 
are needed for purposes of complying with the requirements of the HH 
QRP.

H. Policies Regarding Public Display for the HH QRP

    Section 1899B(g) of the Act requires that data and information 
regarding PAC provider performance on quality measures and resource use 
and other measures be made publicly available beginning not later than 
2 years after the applicable specified `application date'. In the CY 
2018 HH PPS final rule (82 FR 51740 through 51741), we finalized that 
we will publicly display the Medicare Spending Per Beneficiary (MSPB)-
PAC HH QRP beginning in CY 2019 based on 1 year of claims data on 
discharges from CY 2017.
    In the CY 2019 HH PPS proposed rule (83 FR 32446), we proposed to 
increase the number of years of data used to calculate the MSPB-PAC HH 
QRP for purposes of display from 1 year to 2 years. Under this 
proposal, data on this measure would be publicly reported in CY 2019, 
or as soon thereafter as operationally feasible, based on discharges 
from CY 2016 and CY 2017. We also stated that increasing the measure 
calculation and public display periods from 1 to 2 years of data would 
increase the number of HHAs with enough data adequate for public 
reporting for the MSPB-PAC HH QRP measure from 90.7 percent (based on 
August 1, 2014-July 31, 2015 Medicare FFS claims data) to 94.9 percent 
(based on August 1, 2014-July 31, 2016 Medicare FFS claims data). We 
further stated that increasing the measure public display periods to 2 
years would align with the public display periods of these measures in 
the IRF QRP, LTCH QRP, and SNF QRP.
    We invited public comment on our proposal to increase the number of 
years of data used to calculate the MSPB-PAC HH QRP for purposes of 
display from 1 year to 2 years.
    Comment: Most commenters supported changing the reporting period 
for the MSPB-PAC HH QRP measure from 1 year to 2 years.
    Response: We thank the commenters for their support.
    Comment: Several commenters opposed changing the reporting period 
for the MSPB measure from 1 to 2 years. A commenter opposed the 2-year 
reporting period for the MSPB measure, noting that measurement may be 
``smoothed'' and current performance diluted by relying on 2 years of 
data instead of 1 year. This commenter recommended using two years of 
historical data only for low-volume home health agencies that would 
otherwise report insufficient data, and retaining the one-year 
reporting period for larger home health agencies. Two other commenters 
opposed the change to a 2-year reporting period, noting that measures 
should reflect recent data and performance. Another commenter 
questioned the rationale for using a 2-year measure period, noting that 
while this may increase the denominator, measure accuracy might be 
compromised by any changes that occurred during the measurement period.
    Response: We appreciate the commenters' concern about the impact of 
aggregating data across 2 years on the ability to demonstrate 
improvement in a 1-year period. However, we believe that the benefit of 
increasing the number of HHAs in public reporting outweighs the 
expressed concern associated with increasing the measurement period to 
2 years because it enables us to provide more information to consumers 
who may have a limited number of HHAs in their area. Further, 
improvements in performance in a measure over a 1-year period will also 
be included in the 2 years of data, so providers' improvement efforts 
can still be reflected in their 2-year measure scores.
    We disagree with the recommendation to use 2 years of data for low-
volume HHAs but 1 year of data for larger HHAs because HHA performance 
may no longer be comparable using different time periods for data 
collection. Finally, there is no

[[Page 56559]]

evidence to support that increasing the number of years of data used 
for the calculation of measure scores of all HHAs from 1 year to 2 
years might compromise the accuracy of a measure.
    Final Decision: After consideration of public comments we received, 
we are finalizing our proposal as proposed to increase the number of 
years of data used to calculate the MSPB-PAC HH QRP measure for 
purposes of display from 1 year to 2 years.

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

    In the CY 2019 HH PPS proposed rule (83 FR 32446), we did not 
propose changes to the Home Health Care Consumer Assessment of 
Healthcare Providers and Systems[supreg] (HHCAHPS) Survey requirements 
for CY 2019. Therefore, HHCAHPS Survey requirements are as codified in 
Sec.  484.250 and the HHCAHPS survey vendors' data submission deadlines 
are as posted on HHCAHPS website at https://homehealthcahps.org.

VI. Medicare Coverage of Home Infusion Therapy Services

    In this section of the rule, we discuss the new home infusion 
therapy benefit that was established in section 5012 of the 21st 
Century Cures Act. This benefit covers the professional services, 
including nursing services, patient training and education, and 
monitoring services associated with administering infusion drugs by an 
item of durable medical equipment (DME) in a patient's home. This final 
rule with comment period will establish health and safety standards for 
home infusion therapy and provide consistency in coverage for home 
infusion therapy services. In addition, this final rule with comment 
period establishes regulations for the approval and oversight of 
accrediting organizations that provide accreditation to home infusion 
therapy suppliers. This rule also provides information on the 
implementation of the home infusion therapy services temporary 
transitional payments for CYs 2019 and 2020, as mandated by section 
50401 of the BBA of 2018, and finalizes a regulatory definition of 
``Infusion Drug Administration Calendar Day.''

A. General Background

1. Overview
    Infusion drugs and administration services can be furnished 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.
    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. There is also a separate payment for drug 
administration in which the payment for infusion supplies and equipment 
is packaged in the payment for administration. 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.
    Medicare FFS covers outpatient infusion drugs under Part B, 
``incident to'' a physician's services, 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 excluded from 
Part B coverage. This determination is made on a drug-by-drug basis, 
not on a beneficiary-by-beneficiary basis.\71\ The MACs update Self-
Administered Drug (SAD) exclusion lists on a quarterly basis.\72\
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    \71\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
    \72\ 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. The components needed to perform home infusion include the 
drug (for example, antibiotics, immune globulin), equipment (for 
example, a pump), and supplies (for example, tubing and catheters). 
Likewise, nursing services are 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. 
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 nursing time, 
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 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.

[[Page 56560]]

    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 or implantable 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. Only certain 
types of infusion pumps are covered under the DME benefit. The Medicare 
National Coverage Determinations Manual, chapter 1, part 4, Sec.  280.1 
describes the types of infusion pumps that are covered under the DME 
benefit.\73\ For DME infusion pumps, Medicare Part B covers the 
infusion drugs and other supplies and services necessary for the 
effective use of the pump, but does not explicitly require or pay 
separately for any associated home infusion nursing services beyond 
what is necessary for teaching the patient and/or caregiver how to 
operate the equipment in order to administer the infusion safely and 
effectively.\74\ Through local coverage policies, 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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    \73\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS014961.html.
    \74\ See 42 CFR 424.57(c)(12), which states that the DME 
``supplier must document that it or another qualified party has at 
an appropriate time, provided beneficiaries with necessary 
information and instructions on how to use Medicare-covered items 
safely and effectively.''
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2. Home Infusion Therapy Legislation
    Section 5012 of the 21st Century Cures Act (Pub. L. 114-255) (Cures 
Act) creates a separate Medicare Part B benefit category under section 
1861(s)(2)(GG) of the Act for coverage of home infusion therapy-
associated professional services for certain drugs and biologicals 
administered intravenously, or subcutaneously through a pump that is an 
item of DME, effective January 1, 2021. The infusion pump and supplies 
(including home infusion drugs) will continue to be covered under the 
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 included in the payment for 
the DME), remote monitoring, and other monitoring services for the 
provision of home infusion therapy furnished by a qualified home 
infusion therapy supplier in the patient'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 
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 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)(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 CPI for all urban consumers for the 12-
month period ending with June of the preceding year, reduced by the 
multi-factor productivity adjustment. The unit of single payment 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, and the single 
payment amount 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. Health and Safety Standards for Home Infusion Therapy

1. Introduction
    Section 5012 of the Cures Act requires that, to receive payment 
under the Medicare home infusion therapy benefit, home infusion therapy 
suppliers must select a CMS-approved accreditation organization (AO) 
and undergo an accreditation review process to demonstrate that the 
home infusion therapy supplier meets the AO's standards. Section 
1861(iii) of the Act,

[[Page 56561]]

as added by section 5012 of the Cures Act, sets forth four elements for 
home infusion therapy in the following areas: (1) Requiring that the 
patient be under the care of a physician, nurse practitioner, or 
physician assistant; (2) requiring that all patients have a plan of 
care established and updated by a physician that sets out the care and 
prescribed infusion therapy necessary to meet the patient specific 
needs; (3) providing patients with education and training on the 
effective use of medications and equipment in the home (not otherwise 
paid for as durable medical equipment); and (4) providing monitoring 
and remote monitoring services associated with administering infusion 
drugs in a patient's home.
    The Journal of Infusion Nursing standards of practice specifically 
address patient education, and state that it is the clinician's role to 
educate the patient, caregiver, and/or surrogate about the prescribed 
infusion therapy and plan of care including, but not limited to, 
purpose and expected outcome(s) and/or goals of treatment, infusion 
therapy administration; infusion device-related care; potential 
complications; or adverse effects associated with treatment. (Infusion 
Therapy Standards of Practice, 2015).\75\
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    \75\ Infusion Therapy: Standards of Practice, Journal of 
Infusion Nursing, Wolters Kluwer: Jan/Feb 2016 pp S25-S26.
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    Currently, standards for home infusion therapy have been 
established by the current AOs; however, they are not necessarily 
consistent. In order to assure consistency in the areas identified in 
the Act, we are establishing basic standards that all AOs will be 
required to meet or exceed. We proposed universal standards for 
Medicare-participating qualified home infusion therapy suppliers to 
ensure the quality and safety of home infusion therapy services for all 
beneficiaries that these suppliers serve.
    In preparation for developing these standards and to gain a clear 
understanding of the current home infusion therapy supplier private 
sector climate, we reviewed the requirements established by section 
5012 of the 21st Cures Act, performed an extensive review of the 
standards from all six AOs that accredit home infusion suppliers (The 
Joint Commission, Accreditation Commission for Health Care, Compliance 
Team, Community Health Accreditation Partner, Healthcare Quality 
Association on Accreditation, and National Association of Boards of 
Pharmacy), and reviewed various other government and industry 
publications listed in this final rule with comment period. In addition 
to the standards, we reviewed the following documents related to 
coverage:
     Government Accountability Office-10-426 report, which 
describes the state of coverage of home infusion therapy components 
under Medicare fee-for-service prior to the enactment of the Cures Act 
(GAO, 2010).\76\
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    \76\ Government Accountability Office. (2010). Home Infusion 
Therapy. Differences between Medicare and Private Insurers' 
coverage. (GAO Publication No. 10-426). Washington, DC, U.S. 
Government Printing Office.
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     Medicare and Home Infusion white paper written by the 
National Home Infusion Association (NHIA), which provided an overview 
of Medicare coverage provided for Home Infusion Therapy services prior 
to the enactment of the Cures Act, as well as results of a study 
conducted by Avalere Health on the potential savings that could result 
from Medicare coverage of infusion therapy provided in the home 
(National Home Infusion Therapy Association, NDS).\77\
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    \77\ National Home Infusion therapy Association. Medicare and 
Home Infusion White Paper. Retrieved from https://www.nhia.org/resource/legislative/documents/NHIAWhitePaper-Web.pdf.
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     American Society of Health System Pharmacists Guidelines 
on Home Infusion Pharmacy Services, which provided an in-depth overview 
of specialized, complex pharmaceuticals, best practices on providing 
home infusion therapy in the home or alternative site settings, and the 
plans to execute and manage the therapy (American Society of Health-
System Pharmacists. ASHP guidelines on Home Infusion Pharmacy Service, 
2014).\78\
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    \78\ American Society of Health-System Pharmacists. ASHP 
guidelines on Home Infusion Pharmacy Service, 2014. Retrieved from: 
https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/home-infusion-pharmacy-services.ashx?la=en&hash=255092A51D0AE4746C151C51AC7BF82217AC2F76.
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     The requirements of numerous Medicare Advantage plans, 
Medicare FFS, and private insurance plans.
    Upon review of these materials, we believe that there is a 
sufficient private-sector framework already in place to address many of 
the areas that will typically be included in the establishment of basic 
health and safety standards for home infusion therapy. For example, 
existing AO standards include requirements related to plan of care, 
monitoring, patient assessment, quality improvement, and infection 
control. While the exact content of the AO standards vary, we believe 
that the standards are adequate to ensure patient health and safety. 
The AO representing the largest number of home infusion therapy 
suppliers requires that home infusion pharmacies provide certain 
services to ensure safe and appropriate therapy, in compliance with 
nationally recognized standards of practice. Patient training and 
education activities, as part of their required admission procedures, 
include the use of medical and disposable equipment, medication 
storage, emergency procedures, vascular access device management, 
recognition of a drug reaction, and when to report any adverse drug 
event. As such, we concluded that it was appropriate to propose 
requirements for only those elements specifically identified in section 
1861(iii) of the Act. Through the CMS accreditation organization 
process, we would monitor home infusion therapy suppliers to assure 
that services are provided in a safe and effective manner, and would 
consider future rulemaking to address any areas that may need 
improvement in the future. We solicited public comment on this approach 
and invited comments related to the home infusion therapy standards.
2. Home Infusion Therapy Supplier Requirements (Part 486, Subpart I)
    We propose to add a new 42 CFR part 486, subpart I, to incorporate 
the home infusion therapy supplier requirements. The proposed 
regulations would provide a framework for CMS to approve home infusion 
therapy accreditation organizations and give them the authority to 
approve Medicare certification for home infusion therapy suppliers. 
Final subpart I would include General Provisions (Basis and Scope, and 
Definitions) and Standards for Home Infusion Therapy (Plan of Care and 
Required Services).
a. Basis and Scope (Sec.  486.500)
    We proposed to set forth the basis and scope of part 486 at Sec.  
486.500. Part 486 is based on sections 1861(iii)(2)(D) of the Act, 
which establishes the requirements that a home infusion therapy 
supplier must meet in order to participate in the Medicare program. 
These proposed provisions serve as the basis for survey activities for 
the purposes of determining whether a home infusion therapy supplier 
meets the requirements for participation in Medicare. Section 1834(u) 
of the Act serves as the basis for the establishment of a prospective 
payment system for home infusion therapy covered under Medicare. In 
addition, section 1834(u)(5) of the Act establishes the factors for the 
Secretary to designate organizations to accredit suppliers furnishing 
home infusion therapy and requires that organizations be designated not 
later than January 1, 2021.

[[Page 56562]]

b. Definitions (Sec.  486.505)
    At proposed Sec.  486.505, we define certain terms that would be 
used in the home infusion therapy requirements. We define the terms 
``applicable provider'', ``home'', ``home infusion drug'', and 
``qualified home infusion therapy supplier'' in accordance with the 
definitions set forth in section 1861(iii) of the Act. Furthermore, 
section 1861(iii) of the Act includes a definition of the term ``home 
infusion therapy'' that is the basis of the health and safety 
requirements set forth in this final rule with comment period. In 
accordance with the Act, we proposed the following definitions:
     ``Applicable provider'' would mean a physician, a nurse 
practitioner, and a physician assistant.
     ``Home'' would mean a place of residence used as the home 
of an individual, including an institution that is used as a home. 
However, an institution that is used as a home may not be a hospital, 
CAH, or SNF as defined in sections 1861(e), 1861(mm)(1), and 1819 of 
the Act, respectively.
     ``Home infusion drug'' would mean 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. 
The term does not include insulin pump systems or a self-administered 
drug or biological on a self-administered drug exclusion list.
     ``Qualified home infusion therapy supplier'' would mean a 
supplier of home infusion therapy that meets all of the following 
criteria which are set forth at section 1861(iii)(3)(D)(i) of the Act: 
(1) Furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs; (2) ensures 
the safe and effective provision and administration of home infusion 
therapy on a 7-day-a-week, 24-hour-a-day basis; (3) is accredited by an 
organization designated by the Secretary in accordance with section 
1834(u)(5) of the Act; and (4) meets such other requirements as the 
Secretary determines appropriate.
c. Standards for Home Infusion Therapy
    Proposed subpart I, as required by section 5012 of the Cures Act, 
would specify that the qualified home infusion therapy supplier ensure 
that all patients have a plan of care established by a physician.
(1) Plan of Care (Sec.  486.520)
    Proposed Sec.  486.520(a), requires that all patients must be under 
the care of an ``applicable provider'' as defined at Sec.  486.505. 
Proposed Sec.  486.520(b) requires that the qualified home infusion 
therapy supplier ensure that all patients must have a plan of care 
established by a physician that prescribes the type, amount, and 
duration of home infusion therapy services that are furnished. The plan 
of care would also 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 
care and services necessary to meet the patient-specific needs.
    We also proposed, at Sec.  486.520(c), that the qualified home 
infusion therapy supplier must ensure that the plan of care for each 
patient is periodically reviewed by the physician. We did not propose 
to establish a specific timeframe for review requirements, but the 
expectation is that the physician is active in the patient's care and 
can make appropriate decisions related to the course of therapy if 
changes are necessary in regards to the progress of the patient and 
goal achievement with the infusion therapy.
(2) Required Services (Sec.  486.525)
    Section 1861(iii)(2)(D)(II) of the Act specifically mandates that 
qualified home infusion therapy suppliers ensure the safe and effective 
provision and administration of home infusion therapy on a 7-day-a-
week, 24-hour-a-day basis. Infusion drugs are administered directly 
into a vein or under the skin, eliciting a more rapid clinical response 
than with oral medications. Consequently, an adverse effect or a 
medication error could result in a quicker and/or more severe 
complication. Therefore, at Sec.  486.525(a), we proposed to require 
the provision of professional services, including nursing services, 
furnished in accordance with the plan of care. We proposed to require 
that home infusion therapy suppliers ensure that professional services 
are available on a 7-day-a-week, 24-hour-a-day basis in order to ensure 
that patients have access to expert clinical knowledge and advice in 
the event of an urgent or emergent infusion-related situation. This 
requirement is imperative, as the success of home infusion therapy is 
often dependent upon the professional services being available during 
all hours and days of the week that allows for the patient to safely 
and effectively manage all aspects of treatment.
    At Sec.  486.525(b), we proposed to require patient training and 
education, not otherwise paid for as durable medical equipment, and as 
described in 42 CFR 424.57(c)(12). This requirement is consistent with 
section 1861(iii)(2)(B) of the Act. In addition, the patient training 
and education requirements are consistent with standards that are 
already in place, as established by the current AOs of home infusion 
therapy suppliers. This is a best practice, as home infusion therapy 
may entail the use of equipment and supplies with which patients' may 
not be comfortable or familiar.
    At Sec.  486.525(c), we proposed to require qualified home infusion 
therapy suppliers to provide remote monitoring and monitoring services 
for the provision of home infusion therapy services and home infusion 
drugs furnished by a qualified home infusion therapy supplier. This 
proposed requirement is also consistent with section 1861(iii)(2)(B) of 
the Act. Monitoring the patient receiving infusion therapy in their 
home is an important standard of practice that is an integral part of 
providing medical care to patients in their home.\79\ The expectation 
is that home infusion therapy suppliers would provide ongoing patient 
monitoring and continual reassessment of the patient to evaluate 
response to treatment, drug complications, adverse reactions, and 
patient compliance. Remote monitoring may be completed through follow-
up telephone or other electronic communication, based on patient 
preference of communication. However, we do not propose to limit remote 
monitoring to these methods. Suppliers would be permitted to use all 
available remote monitoring methods that are safe and appropriate for 
their patients and clinicians and as specified in the plan of care as 
long as adequate security and privacy protections are utilized. 
Monitoring may also be performed directly during in-home patient 
visits. Additional discussion on remote monitoring and monitoring 
services can be found in section II.C.2.d. of this final rule with 
comment period.
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    \79\ Infusion Therapy: Standards of Practice, Journal of 
Infusion Nursing, Wolters Kluwer: Jan/Feb 2016 pp S25-S26.
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    Comment: We received a few comments related to whether we should 
include specific timeframes for review of the plan of care. Most 
comments suggested that CMS should align the physician review of the 
plan of care with State laws where they exist, while another commenter 
suggested that we require the plan of care be reviewed

[[Page 56563]]

every 30 days. Most commenters also stated that they believed adding 
additional reviews could conflict with the State laws and would create 
undue burden on home infusion therapy suppliers.
    Response: We agree with the commenters that establishing timeframe 
requirements for the physician review of the patient plan of care could 
create duplicative requirements and add burden to home infusion therapy 
suppliers. Therefore, we are not including specific timeframes for the 
review of the plan of care, and will defer to existing State laws and 
regulations.
    Comment: We received several comments requesting that the proposed 
home infusion therapy health and safety standards include various 
requirements for pharmaceutical standards, such as drug preparation and 
dispensing procedures. Specifically, commenters recommended compliance 
with sterile compounding standards and those requirements enforced by 
the United States Pharmacopeia and Food and Drug Administration.
    Response: We agree it is important that all health care providers 
and suppliers, including home infusion therapy suppliers, provide 
services to patients in a safe and professional manner, and in 
accordance with professional standards of practice. To address these 
concerns, we have amended the regulation text at Sec.  486.525 Required 
services, by adding Sec.  486.525(b) which requires that all home 
infusion therapy suppliers must provide home infusion therapy services 
in accordance with nationally recognized standards of practice, and in 
accordance with all applicable state and federal laws and regulations. 
This could include the applicable provisions in the Federal Food, Drug, 
and Cosmetic Act.
    Comment: Several commenters suggested we expand the standard under 
proposed Sec.  486.525, Required services, (a) Professional services. 
Specifically the comments requested that CMS define the term 
``Professional services,'' and to specify the specific services that 
would be applicable. Commenters suggested that the term ``professional 
services'' could be defined to include things such as clinical care 
planning, care coordination, pharmacy services, and nursing services to 
name a few.
    Response: We agree various professional services may be necessary 
in the care of beneficiaries utilizing the Medicare home infusion 
therapy benefit. As stated in the proposed rule preamble, we have 
mirrored the language in section 1861(iii)(2)(A) that requires the 
provision of professional services, including nursing services, 
furnished in accordance with the plan of care by the home infusion 
therapy supplier. By specifically enumerating a specific list of 
services we would risk inadvertently excluding services that may be 
necessary for the care of a specific patient as part of the required 
services under the home infusion therapy benefit. We acknowledge that 
pharmacy services are closely related to the home infusion therapy 
benefit; however, at this time pharmacy services associated with the 
preparation and dispensing of home infusion therapy drugs are covered 
under the Medicare Part B DME benefit and are not part of this specific 
home infusion therapy benefit.
    Comment: We received several comments that did not appear to 
support the proposed regulation. However, the comments were non-
specific in nature, and did not provide any detailed information to 
which we could provide an appropriate response.
    Response: We believe the proposed home infusion therapy health and 
safety standards are important and essential because they provide the 
essential basis for establishing a robust accreditation program that 
will protect the health and safety of Medicare beneficiaries. 
Therefore, we are finalizing, with modifications, the home infusion 
therapy health and safety regulations. As previously described, we 
received several public comments regarding the home infusion therapy 
supplier health and safety regulations proposed at Sec.  486.520, Plan 
of care and Sec.  486.525, Required services. We are finalizing these 
regulations, and are adding the following requirement to Sec.  
486.525(b): All home infusion therapy suppliers must provide home 
infusion therapy services in accordance with nationally recognized 
standards of practice, and in accordance with all applicable state and 
federal laws and regulations.

C. Approval and Oversight of Accrediting Organizations for Home 
Infusion Therapy Suppliers

1. Background
    Section 1861(iii)(3)(D)(III) of the Act, as added by section 
5012(b) of the Cures Act, requires that a home infusion therapy 
supplier be accredited by an AO designated by the Secretary in 
accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of 
the Act identifies factors for designating AOs and modifying the list 
of designated AOs. These statutory factors are: (1) The ability of the 
organization to conduct timely reviews of accreditation applications; 
(2) the ability of the organization take into account the capacities of 
suppliers located in a rural area (as defined in section 1886(d)(2)(D) 
of the Act); (3) whether the organization has established reasonable 
fees to be charged to suppliers applying for accreditation; and, (4) 
such other factors as the Secretary determines appropriate.
    Section 1834(u)(5)(B) of the Act requires the Secretary to 
designate AOs to accredit home infusion therapy suppliers furnishing 
home infusion therapy not later than January 1, 2021. In the proposed 
rule we stated that, there are six AOs that are currently providing 
accreditation to home infusion therapy suppliers, which are: (1) The 
Joint Commission (TJC); (2) Accreditation Commission for Health Care 
(ACHC); (3) Compliance Team (TCT); (4) Community Health Accreditation 
Partner (CHAP); (5) Healthcare Quality Association on Accreditation; 
and (6) National Association of Boards of Pharmacy. However, since the 
publication of the proposed rule, we have learned that there are two 
additional organizations that provide accreditation to home infusion 
therapy suppliers. These organizations are: (1) The Centers for 
Pharmacy Practice Accreditation (CPPA) and (2) URAC.
    Five of these AOs are providing accreditation to home infusion 
therapy suppliers as part of the overall accreditation of home health 
agencies. The remaining AOs are pharmacy associations that have home 
infusion therapy accreditation programs that have not been approved by 
Medicare.
    We proposed to publish a solicitation notice in the Federal 
Register, in which we would invite national AOs to submit an 
application to CMS for approval of their home infusion therapy 
accreditation program. We proposed that this solicitation notice would 
be published after the final rule is published, so that we can 
designate AOs to accredit home infusion therapy suppliers by no later 
than January 1, 2021 as required by 1834(u)(5)(B) of the Act. We 
further proposed that the application submitted by any AOs that respond 
to the solicitation notice would be required to meet all requirements 
set forth in proposed Sec.  488.1010 and demonstrate that their 
substantive accreditation requirements are equal to or more stringent 
than our proposed regulations at part 485, subpart I.
    Section 1861(iii)(3)(D) of the Act requires ``qualified home 
infusion therapy suppliers'' to be accredited by a CMS-approved AO. We 
proposed that, in order for the home infusion therapy suppliers 
accredited by the eight AOs that currently provide non-Medicare

[[Page 56564]]

approved home infusion therapy accreditation to continue receiving 
payment for the home infusion therapy services they provide, the eight 
existing home infusion therapy AOs must submit applications to CMS for 
Medicare approval of their home infusion therapy accreditation 
programs. We made this proposal because the accreditation currently 
being provided by these AOs has not been approved by CMS as required by 
section 1861(iii)(3)(D) of the Act. More specifically, five of these 
existing home infusion AOs are home health agency (HHA) AOs that have 
been approved by CMS to provide HHA accreditation to home health 
agencies. (HHAs). These HHA AOs started offering home infusion therapy 
accreditation as part of their HHA accreditation program, but none of 
these HHA AOs have received separate CMS approval for their home 
infusion therapy accreditation programs. The remaining 3 of the 
existing home infusion AOs are pharmacy association that offer a non-
CMS approved home infusion therapy accreditation programs. As noted, 
all these existing home infusion AOs would have to submit an 
application to CMS for Medicare approval of their home infusion therapy 
accreditation program.
    We proposed that the home infusion therapy accreditation program be 
a separate and distinct accreditation program from the HHA AO's home 
health accreditation program. This would mean that AOs currently 
surveying HHAs would have a separate accreditation program with 
separate survey processes and standards for the accreditation of home 
infusion therapy suppliers. In addition, we proposed to require that 
the applications submitted by all HHA and pharmacy AOs that currently 
provide accreditation to home infusion therapy suppliers meet the 
application requirements set forth in the proposed home infusion 
therapy AO approval and oversight regulations at Sec.  488.1010 and 
meet or exceed the substantive home infusion therapy health and safety 
standards proposed to be set out at 42 CFR part 485, subpart I.
    Section 1834(u)(5)(C)(ii) of the Act states that in the case where 
the Secretary removes a home infusion therapy AO from the list of 
designated home infusion therapy AOs, any home infusion therapy 
supplier that is accredited by the home infusion therapy AO during the 
period beginning on the date on which the home infusion therapy AO is 
designated as an CMS-approved home infusion therapy AO and ending on 
the date on which the home infusion therapy AO is removed from such 
list, shall be considered to have been accredited by an home infusion 
therapy AO designated by the Secretary for the remaining period such 
accreditation is in effect. Under section 1834(u)(5)(D) of the Act, in 
the case of a home infusion therapy supplier that is accredited before 
January 1, 2021 by a home infusion therapy AO designated by the 
Secretary as of January 1, 2019, such home infusion therapy supplier 
shall be considered to be accredited by a home infusion therapy AO 
designated by the Secretary as of January 1, 2023, for the remaining 
period such accreditation is in effect. Home infusion therapy suppliers 
are required to receive accreditation before receiving Medicare payment 
for services provided to Medicare beneficiaries.
    Section 1861(iii)(3)(D) of the Act defines ``qualified home 
infusion therapy suppliers'' as being accredited by a CMS-approved AO. 
In the proposed rule, we proposed to establish regulations for the 
approval and oversight of AOs that accredit home infusion therapy 
suppliers to address the following: (1) The required components to be 
included in a home infusion therapy AO's initial or renewal application 
for CMS approval of the AO's home infusion therapy accreditation 
program; (2) the procedure for CMS' review and approval of a home 
infusion therapy AOs application for CMS approval of its home infusion 
therapy accreditation program; and (3) the process for ongoing 
monitoring and oversight of the CMS-approved home infusion therapy AOs.
    Comment: Another commenter stated that they were slightly confused 
by the use of this proposed rule as the appropriate forum for these 
significant changes.
    Response: The issues presented in the proposed rule involve the 
payment for home infusion therapy services, the accreditation of 
suppliers that provide home infusion therapy services to patients in 
their homes and the approval and oversight of AOs that accredit home 
infusion therapy suppliers. Most of the AOs that currently provide 
accreditation for home infusion therapy suppliers are AOs that also 
accredit Home Health Agencies (HHAs). Further, the home infusion 
therapy accreditation offered by these HHA AOs is currently provided as 
part of these HHA AO's home health accreditation program. Therefore, we 
believe that the Home Health Prospective Payment System (HH PPS) rule 
is an appropriate venue in which to present these issues.
    Comment: Several commenters stated general support for the 
establishment of an accreditation program for home infusion therapy 
suppliers. One of these commenters stated that home infusion therapy is 
a service that can be safely and effectively provided in the home 
setting, when provided by an accredited home infusion therapy supplier 
under a physician ordered plan of care. Several commenters stated 
general agreement with the AO approval and oversight provisions for 
home infusion therapy AOs but suggested that the health and safety 
standard regulations need to include additional provisions including 
pharmacy safety standards such the requirements for sterile 
compounding.
    Response: We thank these commenters for their support of these 
proposals. We refer those commenter that suggested changes or additions 
to the home infusion therapy health and safety standards to section 
VI.B. of this for further discussion of these comments.
    Comment: Several commenters stated that the accreditation section 
of the rule is silent as to when CMS plans on making accreditation a 
requirement of participation for reimbursement. These commenters 
requested that CMS provide clarity on the effective date of this 
requirement.
    Response: Section 1834(u)(5)(B) of the Act requires that ``not 
later than January 1, 2021, the Secretary shall designate organizations 
to accredit suppliers furnishing home infusion therapy''. The permanent 
home infusion therapy benefit provided under the 21st Century Cures Act 
is to begin on January 1, 2021. Therefore, all home infusion therapy 
suppliers must be accredited by no later than January 1, 2021 in order 
to receive Medicare payment for furnishing home infusion therapy 
services under the permanent home infusion therapy benefit. CMS plans 
to publish a solicitation notice in the Federal Register which will 
announce that we are seeking national AOs to accredit home infusion 
therapy suppliers and invite interested AOs to submit their 
applications to CMS. We plan to publish this solicitation notice very 
soon after publication of the final rule. We will be prepared to begin 
accepting applications from prospective AOs seeking CMS approval of a 
home infusion therapy accreditation program immediately after 
publication of the solicitation notice.
    Comment: A commenter stated the opinion that ``the accreditation 
section of the rule is a statutory construct of the 21st Century Cures 
Act as a requirement to become a qualified home infusion provider for 
the permanent home infusion services reimbursement.'' This commenter 
further stated the belief that ``the BBA does not require accreditation

[[Page 56565]]

to become a ``qualified'' home infusion therapy supplier and relies on 
a qualified home infusion provider to be a qualified home infusion 
provider and a pharmacy enrolled in the DME program and a pharmacy 
licensed in the state where applicable home infusion drugs are 
administered.''
    Response: Section 50401 of the Bipartisan Budget Act (BBA) of 2018 
does not specifically state accreditation is required to become a 
``qualified'' home infusion therapy for payment of the temporary 
transitional home infusion therapy services. However for the permanent 
home infusion therapy services benefit, section 5012 of the 21st 
Century Cures Act added section 1861(iii)(3)(D)(i) to the Act that 
defines the term 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 or 
services or supplier furnishes items or services and that . . . . 
``(III) is accredited by an organization designated by the Secretary 
pursuant to section 1834(u)(5) . . .''. Further, this statutory 
provision does not restrict ``qualified'' home infusion therapy 
suppliers to only pharmacies, but includes physicians, other providers 
of services and suppliers as possible types of home infusion therapy 
suppliers. However, section 50401(a) of the BBA of 2018, adding new 
section 1834(u)(7)(F) to the Act, requires that ``eligible home 
infusion suppliers'' for the temporary transitional payment be 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. 
Accreditation for home infusion therapy services is not required for 
these pharmacies.
    Comment: Another commenter requested that CMS clarify that all 
eligible accrediting organizations may submit an application to CMS for 
approval of a home infusion therapy accreditation program and not just 
the eight AOs listed in the proposed rule.
    Response: Regarding comments on the eight AOs listed in the 
proposed rule, since publication of the proposed rule, we are made 
aware of two additional AOs for home infusion therapy suppliers. The 
eight existing AOs that provide home infusion therapy accreditation 
are: (1) The Joint Commission; (2)Accreditation Commission for 
Healthcare (ACHC); (3) Community Health Accreditation Partner (CHAP); 
(4) The Compliance Team (TCT); (5) National Association of Pharmacy 
Boards (NAPB); (6) Healthcare Quality Association on Accreditation 
(HQAA); (7) The Centers for Pharmacy Practice Accreditation (CPPA) and 
(8) URAC. In accordance with this final rule with comment period, any 
national AO that provides accreditation for home infusion therapy 
suppliers that meets the following requirements may submit an 
application to CMS requesting approval of their home infusion therapy 
accreditation program: (1) The AO must be national in scope; (2) the AO 
must have a home infusion therapy accreditation program that is 
separate and distinct from other accreditation programs they have; (3) 
the AO must have home infusion therapy accreditation standards that 
meets or exceeds the Medicare home infusion therapy health and safety 
standards to be codified at 42 CFR 486.500 to 486.525; and (4) the home 
infusion therapy AO must accredit only those home infusion therapy 
suppliers that provide all services required by the Medicare home 
infusion therapy health and safety and payment regulations.
    Upon receipt of an application from a home infusion therapy AO 
seeking CMS approval of its home infusion therapy accreditation 
program, CMS will determine its completeness in accordance with the 
requirements set forth at Sec.  488.1010(a). Once CMS has determined 
that an application is complete, CMS will then review it to determine 
whether the application meets the requirements set forth at Sec.  
488.1000 to Sec.  488.1050 and whether the AOs accreditation standards 
meet or exceed the Medicare home infusion therapy health and safety 
accreditation requirements set forth at proposed Sec.  486.500 to Sec.  
486.525. CMS will also assess whether the AO accredits only those home 
infusion therapy suppliers that provide all services required by the 
Medicare home infusion therapy health and safety and payment 
regulations. Pursuant to Sec.  488.1010(d), CMS must complete the 
application review process and issue a decision within 210 days from 
the date that CMS determines that the application is complete. In 
accordance with Sec.  488.1020(b), CMS will publish a final notice in 
the Federal Register announcing our decision to approve or deny a 
national accrediting organization application. The notice will specify 
the basis for the CMS decision.
    Comment: Several commenters raised the question of whether the 
National Association of Boards of Pharmacy (NABP), which is one of the 
existing AOs that provide accreditation to home infusion therapy 
suppliers, would qualify as a CMS-approved home infusion therapy AO. 
These commenters stated that the NABP's survey process focuses only on 
pharmacy personnel education, practice of pharmacy including sterile 
compounding, patient counseling. These commenters further stated that 
the NABP addresses sterile compounding in their standards but does not 
address the plan of care process, the complexities of patient care 
monitoring or any professional staff components. These commenters 
further stated that they do not consider NABP a full-service home 
infusion accreditation organization and few third party payers in the 
private sector accept or recognize NABP alone as sufficient 
accreditation for home infusion. These commenters expressed the opinion 
that they want the industry to be held to a higher standard than what 
NABP accreditation provides.
    Response: Any national AO that provides accreditation for home 
infusion therapy suppliers that meets the requirements set forth 
previously may submit an application to CMS requesting approval of a 
home infusion therapy accreditation program. In addition, we cannot 
predetermine whether the NABP would qualify as a CMS-approved home 
infusion therapy AO nor can we prohibit any organization from applying 
to be an AO.
    Upon receipt of an application, CMS will determine its completeness 
in accordance with the requirements set forth at Sec.  488.1010(a). 
Once CMS has determined that the application is complete, CMS will 
review it to determine whether the application meets the requirements 
set forth at Sec.  488.1000 to Sec.  488.1050 and whether the AOs 
accreditation standards meet or exceed the Medicare home infusion 
therapy health and safety accreditation requirements set forth at 
proposed Sec.  486.500 to Sec.  486.525. CMS will also assess whether 
the AO accredits only those home infusion therapy suppliers that 
provide all services required by the Medicare home infusion therapy 
health and safety and payment regulations. Pursuant to Sec.  
488.1010(d), CMS must complete the application review process and issue 
a decision within 210 days from the date CMS determines that the 
application is complete. In accordance with Sec.  488.1020(b), CMS will 
publish a final notice in the Federal Register announcing our decision 
to approve or deny a national accrediting organization's application. 
The final notice will specify the basis for CMS' decision.
    If the NABP were to submit an application to CMS for approval of a 
home infusion therapy accreditation program, we would be required to 
give the same consideration to that

[[Page 56566]]

application as we would give to any other application we receive. We 
would be required to review the application to determine whether the 
NABP's home infusion therapy accreditation program meets the previously 
stated requirements. We would also be required to review the 
application to determine whether the NABP's application meets the 
requirements set forth is Sec.  488.1010.
    It is interesting to point out that these same commenters strongly 
advocated for CMS to ``grandfather'' in the existing eight home 
infusion therapy AOs which were recognized in the proposed rule. These 
commenter's argued that for CMS to do otherwise would be to defeat 
Congress's clear direction and understanding that the accreditation 
program be functional by January 1, 2019, and would severely disrupt 
care for patients. As the NAPB is one of eight existing home infusion 
therapy accrediting organizations, it would seem that these commenters 
have on one hand, advocated that the NABP should ``grandfathered'' in 
as one of the eight existing home infusion therapy AOs, while also 
advocating for their exclusion as a home infusion therapy AO. These 
arguments conflict with one another.
    Comment: Several commenters expressed the belief that the HHA AOs 
with an existing home infusion therapy accreditation program should not 
be required to have a Home Infusion therapy accreditation program that 
is separate and distinct from their HHA accreditation programs because 
this would place unnecessary burden on these HHA AOs. These commenters 
stated their disagreement with CMS' proposal that the home infusion 
therapy benefit should fall under an entirely separate accreditation 
process from an existing home care program. These commenters strongly 
recommended that CMS allow HHA AOs to satisfy the specified home 
infusion therapy accreditation requirement within their home care 
programs. In support of this request, a commenter stated the belief 
that including home infusion therapy services as part of the larger 
home health accreditation would promote a higher quality of care as 
well as a more coordinated and comprehensive approach to care delivery.
    Several commenters suggested that the accreditation of home 
infusion therapy suppliers should be allowed as part of an HHA AO's 
overall accreditation and not require a totally separate accreditation 
as long as the accreditation organization meets all the CMS mandated 
home infusion therapy accreditation health and safety standards. Some 
of these commenters stated the belief that requiring AOs with existing 
home infusion therapy accreditation programs to submit a home infusion 
therapy accreditation program that is separate and distinct from their 
HHA accreditation program could affect the quality of care provided by 
these AOs and that such a policy would further fragment care delivery.
    Another commenter suggested that CMS should permit a separate home 
infusion therapy accreditation module, approved by CMS, under an 
existing accreditation program because CMS has already done 
considerable review of the existing HHA accreditation programs and 
could benefit from working with the AOs to build on already existing 
standards to establish a standard set of standards that could be 
included for all accreditation organizations rather than developing a 
totally separate, free-standing home infusion therapy accreditation 
program.
    Several commenters stated the belief that the requirement for a 
distinct, freestanding accreditation program for home infusion therapy 
suppliers would place additional burden on home care programs that 
currently provide home infusion therapy services as well as on 
accrediting organizations (AOs). One of these commenters expressed the 
concern that a totally separate accreditation program for HIT only 
would involve excessive cost and personnel time for agencies and CMS.
    Response: We believe that it would not be permissible for CMS to 
allow the Home Health accrediting organizations to maintain the home 
infusion therapy accreditation program as part of their overall HHA 
accreditation program for several reasons. First, sections 
1861(iii)(3)(D)(i) and 1834(u)(5) of the Act are clear that an 
accreditation is required for qualified home infusion therapy suppliers 
and that CMS must approve AOs accrediting these suppliers. Pursuant to 
section 1834(u)(5)(B) of the Act, CMS is mandated to designate AOs to 
accredit home infusion therapy suppliers by no later than January 1, 
2021. This statutory mandate does not include language that would allow 
CMS to approve existing home infusion therapy accreditation programs 
that are co-mingled with other accreditation programs.
    Second, given that our review of the commenter's HHA accreditation 
program standards occurred prior to the passage of the statutory 
mandate for CMS to designate AOs to accredit home infusion therapy 
suppliers our review of AOs' HHA programs focus on and assess the AO's 
HHA accreditation program standards and adherence to the CMS Home 
Health Conditions of Participation. Therefore, the reliance on our 
previous review of the HHA accreditation program standards and survey 
processes would not be sufficient to ensure that a HHA AO's home 
infusion therapy accreditation program would meet or exceed Medicare 
home infusion therapy health and safety standards that we are 
finalizing in this rule.
    In addition, in this rule, we have proposed to establish new home 
infusion therapy health and safety accreditation standards that each 
home infusion therapy AO must incorporate into their home infusion 
therapy accreditation standards. When we reviewed the HHA AOs previous 
application, this review would have occurred prior to the publication 
of the CY 2019 Home Health proposed rule. Therefore, the HHA AOs could 
not yet have incorporated the new home infusion therapy health and 
safety standards into the accreditation standards they submitted with 
their applications. The establishment of the Medicare home infusion 
therapy health and safety accreditation standards will require that the 
existing home HHA/home infusion therapy AOs revise their home infusion 
therapy accreditation standards to ensure that they meet or exceed 
these new home infusion therapy health and safety standards. Therefore, 
we must require that each of the existing HHA/home infusion therapy AOs 
submit for our review, a new application seeking approval for a 
separate and distinct accreditation program for home infusion therapy 
suppliers, to ensure that the accreditation standards used meet or 
exceed the Medicare home infusion therapy health and safety standards.
    Comment: Several commenters have stated that CMS should allow home 
health agency AOs to continue to provide home infusion accreditation 
services as part of their larger home health accreditation program. 
These commenters believe that providing home infusion therapy 
accreditation services as part of the AO home health program would both 
promotes higher quality care for beneficiaries and reduce 
administrative burden.
    Response: We respectfully disagree with these commenters, because 
the commenters have provided no specific facts or circumstances which 
would explain how having a separate and distinct home infusion therapy 
accreditation program would promote a higher quality of care.
    Moreover, the statutory requirement of section 1834(u)(5) of the 
Act

[[Page 56567]]

contemplates an independent accreditation process for home infusion 
therapy suppliers.
    Comment: Several commenters stated concern that it would be too 
burdensome to require HHA AOs with existing home infusion therapy 
accreditation programs to develop a new home infusion therapy 
accreditation program that is distinct from their existing HHA 
accreditation program.
    Response: We respectfully disagree with these commenters. We 
believe the additional burden will be minimal. Moreover, the statute 
mandates an AO program and application process that is structurally 
separate from accreditation for HHAs. While these commenters may incur 
some initial burden to create a home infusion therapy accreditation 
program that is separate and distinct from their home health 
accreditation program, we believe that this burden would be limited for 
several reasons. First, these commenters have stated in their comments 
that they do have established home infusion therapy standards and 
survey processes but that they are co-mingled with the AOs home health 
accreditation standards and survey processes. As these home health AOs 
already have established home infusion therapy accreditation standards 
and survey processes, we believe that it would be an uncomplicated 
matter for these AOs to separate their home infusion therapy standards 
and survey processes from their home health accreditation standards and 
survey processes. What we mean by this is that the AO could simply take 
the documents which contains the combined home health/home infusion 
therapy accreditation standards and survey processes and cut and paste 
the home infusion therapy accreditation language into a separate 
document. This task would only need to be performed once. Further, we 
believe the benefits of having a home infusion therapy accreditation 
program that is separate and distinct from the home health AOs home 
health accreditation program far outweighs the burden associated with 
the initial separation of the home infusion therapy accreditation 
program and home health accreditation program standards and survey 
processes.
    Comment: Another commenter pointed out that ``HHAs have 
historically provided professional services associated with home 
infusion to individuals under their care, and further stated that they 
applauded both Congress and CMS for moving forward in implementing this 
important benefit and the additional support and resources it 
represents.'' However, several other commenters stated that home health 
agencies do not own or operate pharmacies, prepare home infusion drugs, 
provide the care coordination necessary to manage drug infusion, or 
provide a home infusion benefit. These commenters further stated that 
home infusion providers are neither certified nor authorized to offer 
the myriad of care services required of a home health agency. Thus, 
there is no relationship, overlap or intersection between the two 
benefits. Home health agencies will continue to provide the home health 
benefit for Medicare patients, and home infusion pharmacies will 
provide the new separate home infusion benefit for their Medicare 
patients.
    Response: We agree with this commenter and we believe that HHAs are 
in a unique position to provide both home infusion therapy services and 
home health services to patients in their homes. Under the Medicare 
home infusion therapy benefit in section 1861(iii) of the Act, as added 
by section 5012 of the Cures Act, home infusion therapy services are 
available for those individuals receiving eligible home infusion drugs. 
Eligible home infusion therapy drugs are defined under section 
1861(iii)(3)(C) of the Act, as a 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. The services that are to be provided and paid for by 
Medicare do not include the provision of the home infusion drug, DME 
infusion pump, or supplies therefore, it is not necessary for a home 
infusion therapy supplier to be a licensed pharmacy.
    Comment: Several commenters expressed the opinion that CMS has 
delayed in proposing the home infusion therapy AO regulations, and that 
this has caused the likelihood that the home infusion therapy AOs will 
be unable to apply for CMS approval, much less that CMS will have 
completed the accreditation process for home infusion AOs, prior to 
January 1, 2019. These commenters urged CMS to ``grandfather'' in 
existing accreditations to entities such as the eight AOs recognized in 
the proposed rule. The commenters suggest that for CMS to do otherwise 
would be to defeat Congress's clear direction and understanding that 
the accreditation program be functional by such date, and would 
severely disrupt care for patients. These commenters stated the belief 
that such action would be consistent with section 1834(u)(7)(F) of the 
Act, as added by section 50401 of the BBA of 2018, where Congress 
expressed its acceptance of such accreditation as sufficient on January 
1, 2019 when the Transition benefit will begin.
    Response: We respectfully disagree with these commenters' 
contention that CMS delayed in proposing the home infusion therapy AO 
regulations. The 21st Century Cures Act, which is the legislation that 
established the requirement for accreditation of home infusion therapy 
suppliers, was signed into law December 13, 2016. Thereafter, time was 
required to develop our plan for implementation, which occurred through 
mid to late 2017. By the time that the implementation planning phase 
was completed, the CY 2018 Home Health Prospective Payment proposed and 
final rules had already been published. Therefore, the CY 2019 Home 
Health Prospective Payment System Proposed Rule was the first 
appropriate venue in which CMS could make these proposals. Moreover, 
section 1834(u)(5)(B) of the Act, as added by the 21st Century Cures 
Act, requires that ``[n]to later than January 1, 2021, the Secretary 
shall designate organizations to accredit suppliers furnishing home 
infusion therapy.'' This means that it was intended that CMS would have 
until January 1, 2021 to solicit and approve AOs to accredit home 
infusion therapy suppliers for the permanent Medicare home infusion 
therapy services benefit for which payment to qualified home infusion 
therapy supplier will begin on January 1, 2021.
    As stated in the proposed rule, we plan to publish a solicitation 
notice seeking national AOs to accredit home infusion therapy suppliers 
shortly after publication of the final rule. In addition, Sec.  
488.1010(d) requires CMS to complete its review of an application 
submitted by a home infusion therapy AO within 210 calendar days from 
the date that CMS determines that an application is complete. If we 
publish the solicitation notice by December 31, 2018 and receive 
applications from prospective home infusion therapy AOs during the 
first 5 months of 2019, we would be required to complete our review of 
these applications and issue our decisions by December 31, 2019, which 
is 1 full year before the January 1, 2021 deadline. Assuming we publish 
the solicitation notice by December 31, 2018, and considering that we 
must complete review of the application within 210 days, there would be 
a 16-month period in which prospective home infusion therapy AOs could 
submit their application for CMS review and obtain approval by the 
January 1, 2021 deadline specified in section 1834(u)(5)(B) of the Act.

[[Page 56568]]

    The existing AOs that have been providing accreditation of home 
infusion therapy suppliers already have established home infusion 
therapy accreditation programs and accreditation standards. A number of 
commenters have stated that their respective home infusion therapy 
standards already meet or exceed the CMS proposed home infusion therapy 
accreditation health and safety standards and therefore believe that 
they should not be required to submit an application to CMS for 
approval. However, if this is the case, we believe that it should not 
take these AOs long to prepare the information and documentation 
required to apply for CMS approval of their home infusion therapy 
accreditation programs.
    Likewise, we do not believe that it would take a long period of 
time for the HHA AOs that accredit home infusion therapy suppliers to 
prepare and submit their applications for CMS approval of a separate 
and distinct home infusion therapy accreditation program. It is our 
understanding from the comments received that these AOs have home 
infusion therapy accreditation standards that already meet or exceed 
the CMS proposed home infusion therapy accreditation health and safety 
standards; however, these home infusion therapy accreditation standards 
are integrated into the AO's HHA accreditation program. We believe that 
it would be an uncomplicated matter for these HHA AOs to segregate 
their home infusion therapy accreditation program into an individual 
accreditation program. As these AOs have previously established one or 
more accreditation programs and survey processes in the past, and have 
prepared and submitted one or more applications to CMS for approval of 
these accreditation programs, we believe that it would take these AOs 
less time and effort to do so for a separate and distinct home infusion 
therapy accreditation program.
    Comment: Several commenters expressed the opinion that the 
Congressional intent was for CMS to accept the accreditation provided 
by the existing home infusion therapy AOs as being sufficient as of 
January 1, 2019 when the transitional benefits begin. Several 
commenters suggested that section 1834(u)(5)(D) requires CMS to deem 
any home infusion supplier accredited by a home infusion therapy AO 
designated or otherwise recognized and accepted by CMS prior to January 
1, 2019, to be deemed accredited through January 1, 2023.
    Response: We do agree that the existing home infusion therapy 
accreditation provided by the 8 existing home infusion therapy 
accreditation organizations prior to or on January 1, 2019 and still in 
effect on January 1, 2021, would be deemed to meet our accreditation 
requirements through at least January 1, 2023, once the permanent 
program goes into effect on January 1, 2021. Accreditation is not 
required for the transitional program set out at 1834(u)(7) of the Act. 
CMS cannot designate AOs until after January 1, 2019 (when our 
standards and designation procedures become effective).
    Section 1834(u)(5)(D) titled ``Rule for Accreditations Made Prior 
to Designation'' refers to accreditations of home infusion suppliers 
that occurred ``prior to the Secretary's designation'' of AOs. This 
provision applies only to those AOs that are ultimately approved by 
CMS; the eight AOs currently providing accreditation receive no special 
consideration. Should any of the eight apply and be approved, any 
supplier with an active accreditation as of January 1, 2019 that is 
still active on January 1, 2021, when the accreditation requirement 
goes into effect, will be deemed to have a recognized accreditation 
until at least January 1, 2023, and longer if their accreditation lasts 
for a longer period.
2. Process and Standards for Home Infusion Therapy Accreditation and 
the Approval and Oversight of Accrediting Organizations With CMS-
Approved Accreditation Programs for Home Infusion Therapy Services
a. Establishment of Regulatory Requirements
    We proposed to establish new regulations in a new subpart L in 42 
CFR part 488 that would govern CMS' approval and oversight of AOs that 
accredit home infusion therapy suppliers. We believe these new 
regulations would provide CMS with reasonable assurance that the home 
infusion therapy AO's accreditation program requirements are consistent 
with the appropriate Medicare accreditation program requirements. 
Further, we believe that these proposed regulations would provide CMS 
with a way to provide oversight for AOs that accredit home infusion 
therapy suppliers, and provide CMS with authority over the home 
infusion therapy suppliers.
    We proposed to implement a comprehensive, consistent and 
standardized set of AO oversight regulations for accreditors of home 
infusion therapy suppliers. It is our intention to provide home 
infusion therapy AOs with the flexibility to innovate within the 
framework of these regulations while assuring that their accreditation 
standards meet or exceed the appropriate Medicare requirements, and 
their survey processes are comparable to those of Medicare. 
``Flexibility to innovate'' means that AOs retain the freedom to 
develop their own accreditation standards and survey processes, so long 
as the AO ensures that they meet the health and safety standards 
(contained in 42 CFR part 486, subpart B) and the AO meets the 
requirements of the AO approval and oversight regulations.
    The proposed regulations would reflect requirements similar to 
those in place for the oversight of national AOs for Medicare-certified 
providers and suppliers which are codified at 42 CFR 488.1 through 
488.13 and 42 CFR part 489, but would be modified, as appropriate, to 
be applicable for accreditors of home infusion therapy suppliers. We 
believe that it is important to have AO approval and oversight 
regulations that are as consistent as possible across all AOs and to 
treat all AOs in a similar manner.
b. Consideration of Existing Regulations
    In formulating our approach to implementing the statutory 
requirements related to accreditation organizations, we had considered 
using the regulations at 42 CFR 488.1 to 488.13 for the approval and 
oversight of AOs that accredit home infusion therapy suppliers. 
However, we decided not to do so because we believe that Congress, by 
setting out separate accreditation organization approval standards for 
home infusion therapy suppliers at 1834(u)(5)(A) of the Act, intended 
approval for this accreditation program to be a discrete process. We 
believe that having a separate set of approval regulations applicable 
only to home infusion therapy suppliers will best reflect Congress's 
intent.
    Only limited portions of the regulations at Sec. Sec.  488.1 
through 488.13 will apply to AOs that accredit home infusion therapy 
suppliers. For example, Sec.  488.6, regarding accredited provider 
entities' participation in Medicaid, will not apply to home infusion 
therapy because home infusion therapy suppliers is not a benefit 
specified in our Medicaid regulations.
    Section 488.7, titled ``Release and use of accreditation surveys'' 
and Sec.  488.8 titled ``Ongoing review of accrediting organizations'' 
will have parallel provisions applicable to AOs that accredit home 
infusion therapy suppliers (Sec.  488.1025). However, Sec.  488.9 
titled ``Validation surveys'' will not have a parallel provision 
applicable to

[[Page 56569]]

AOs for home infusion therapy suppliers because the State Survey Agency 
(SA) only performs validation surveys for AOs that operate under the 
statutory authority of section 1865 of the Act. In addition, section 
1864(a) of the Act provides, that by agreement with the Secretary, the 
SA shall provide services to the following Medicare certified 
healthcare providers: hospitals, skilled nursing facilities, home 
health agencies, hospice programs, rural health clinics, critical 
access hospitals, comprehensive outpatient rehabilitation facilities, 
laboratories, clinics, rehabilitation agencies, public health agencies, 
or ambulatory surgical centers. Home infusion therapy suppliers are not 
included in this list.
    Section 488.10, titled ``State survey agency review: Statutory 
provisions'', Sec.  488.11 titled ``State survey agency functions'' and 
Sec.  488.12 titled ``Effect of survey agency certification'' will also 
not have parallel provisions applicable to home infusion therapy AOs. 
This is because, as stated previously, the SA does not perform 
validation surveys for AOs that accredit home infusion therapy 
providers. Section 488.13, titled ``Loss of accreditation'' provides 
that ``if an accrediting organization notifies CMS that it is 
terminating a provider or supplier due to non-compliance with its CMS-
approved accreditation requirements, the SA will conduct a full review 
in a timely manner.'' This section will also not have parallel 
provisions applicable to AOs that accredit home infusion therapy 
suppliers because this regulation section requires use of the SA.
    Section 488.14 titled, ``Effect of QIO review'' provides that 
``when a QIO is conducting review activities under section 1154 of the 
Act and part 466 of this chapter, its activities are in lieu of the 
utilization review and evaluation activities required of health care 
institutions under sections 1861(e)(6), and 1861(k) of the Act.'' This 
section will not have parallel provisions applicable to AOs for home 
infusion therapy suppliers because it is only applicable only to 
hospitals.
    Finally, Sec.  488.18, titled ``Documentation of findings'' states 
that ``the findings of the State agency with respect to each of the 
conditions of participation, requirements (for SNFs and NFs), or 
conditions for coverage must be adequately documented.'' As noted 
previously, we will not be including a parallel provision applicable to 
AOs that accredit home infusion therapy suppliers because it involves 
the activities of the SAs, which will not be involved in the home 
infusion therapy supplier accreditation process.
    In conclusion, a majority of sections contained in Sec. Sec.  488.1 
through 488.13 do not apply to home infusion therapy AOs and home 
infusion therapy suppliers. Therefore, we have created a separate set 
of regulations that are specifically applicable to home infusion 
therapy AOs.
    We sought comment on our decision not to use the existing 
regulation at Sec. Sec.  488.1 through 488.13. We did not receive any 
comments on this topic.
c. Consideration of a Validation Process for Accrediting Organizations 
That Accredit Home Infusion Therapy Suppliers
    Our conventional validation process involves the participation of 
the CMS Regional Offices (ROs) to request the State Survey Agency to 
conduct an onsite validation (follow-up) survey within 60 days of an 
AO's onsite survey. The purpose of a validation survey is to evaluate 
the ability of that AO's survey process to identify serious, condition 
level deficiencies.
    We did not propose to establish a validation program requirement 
for home infusion therapy AOs and suppliers due to a number of resource 
constraints. Several factors limit our ability to establish and 
implement a validation program for home infusion therapy AOs. First, as 
mentioned previously, the SAs are not available to perform validation 
surveys for home infusion therapy AOs. This is because, pursuant to 
section 1864(a) of the Act, the SA, enters into an agreement with the 
Secretary to provides services to only a limited number of healthcare 
provider types (that is, hospitals, skilled nursing facilities, home 
health agencies, hospice programs, rural health clinics, critical 
access hospitals, comprehensive outpatient rehabilitation facilities, 
laboratories, clinics, rehabilitation agencies, public health agencies, 
or ambulatory surgical centers.
    We sought public comment on the decision not to propose a 
validation process at this time.
    Even though we would not have a formal validation process in place, 
we would be able to monitor the performance of the home infusion 
therapy AOs as part of the ongoing AO oversight process provided for in 
the home infusion therapy AO approval and oversight regulations at 
Sec. Sec.  488.1010 through 488.1050. For example, under proposed Sec.  
488.1030 we would have the ability to carry out performance reviews to 
evaluate the performance of each CMS-approved home infusion therapy 
accreditation program on an ongoing basis; comparability reviews to 
assess the equivalency of a home infusion therapy AO's CMS-approved 
program requirements with the comparable Medicare home infusion therapy 
accreditation requirements after CMS imposes new or revised Medicare 
accreditation requirements; and standards reviews when a home infusion 
therapy accrediting organization proposes to adopt new or revised 
accreditation standards. We may also perform CMS-approved home infusion 
therapy accreditation program review if a comparability, performance, 
or standards review reveals evidence of substantial non-compliance of a 
home infusion therapy AO's CMS-approved home infusion therapy 
accreditation program with the requirements of this subpart. (See Sec.  
488.1005 for a definition of ``substantial non-compliance'').
    In addition, proposed Sec.  488.1035 would require the home 
infusion therapy AOs to submit information to CMS which would help us 
monitor the AO's performance. This information would also help to 
ensure that the home infusion therapy suppliers accredited by the AO 
provide care that meets the health and safety standards contained in 42 
CFR part 486, subpart B. This information includes the following:
     Copies of all home infusion therapy supplier accreditation 
surveys, together with any survey-related information.
     Notice of all accreditation decisions.
     Notice of all complaints related to the AO's accredited 
suppliers.
     Information about all home infusion therapy accredited 
suppliers against which the home infusion therapy accreditation 
organization has taken remedial or adverse action, including 
revocation, withdrawal, or revision of the providers or suppliers 
accreditation.
     Annual basis, summary data specified by CMS that relate to 
the past year's accreditation activities and trends.
     Notice of any changes in the home infusion therapy 
accrediting organization's accreditation standards or requirements or 
survey process.
    Comment: Several commenters agreed with CMS that validation surveys 
should not be required for home infusion therapy AOs. One of these 
commenters agreed with CMS' position that the performance reviews 
performed under proposed Sec.  488.1030 would provide more objective 
and effective data about the AOs performance.
    Response: We thank these commenters for their input.
    Final Decision: In consideration of the comments received, we are 
finalizing this proposal without modification and

[[Page 56570]]

will perform ongoing monitoring as part of the approval and ongoing 
oversight process for home infusion therapy AOs.
d. Application Requirement for AOs That Currently Provide Accreditation 
for Home Infusion Therapy Suppliers
    We proposed to establish regulations for the approval and oversight 
of AOs for home infusion therapy suppliers. We also proposed the health 
and safety standards which home infusion therapy suppliers must meet, 
and which the home infusion AOs must meet or exceed in their 
accreditation standards. These health and safety standards are being 
set forth in this final rule with comment period at 42 CFR part 486, 
subpart I. The AOs that currently accredit home infusion therapy 
suppliers have not heretofore been governed by any CMS regulations 
related to home infusion therapy accreditation or health and safety 
standards. These AOs have each created their own set of accreditations 
standards. These accreditation standards vary from AO to AO.
    Section 1834(u)(5)(C) of the Act requires home infusion therapy 
suppliers to be accredited in order to receive payment for the services 
they provide. We proposed to require that the home infusion therapy 
accreditation program submitted to CMS for approval by each of the AOs 
that currently accredit home infusion therapy suppliers be separate and 
distinct accreditation programs that are not part of the AOs home 
health accreditation program. We proposed to further require that the 
AOs home infusion therapy accreditation standards meet or exceed the 
health and safety standards for home infusion therapy suppliers. 
Finally, we would require that the application meet the requirements of 
proposed 42 CFR 488.1010.
e. Oversight of Home Infusion Therapy Accrediting Organizations
    As noted previously, we proposed to create a new set of regulations 
titled, ``Approval and Oversight of Home Infusion Therapy Supplier 
Accrediting Organizations'' at 42 CFR part 488, subpart L. These 
proposed regulations would set forth the application and reapplication 
procedures for national AOs seeking approval or re-approval of 
authority to accredit home infusion therapy suppliers; ongoing CMS 
oversight processes for approved AOs that accredit home infusion 
therapy suppliers; and, appeal procedures for AOs that accredit home 
infusion therapy suppliers. In this section of the final rule, we 
describe our regulatory provisions.
    The following sections discuss the regulations, in their order.
(1) Basis and Scope (Sec.  488.1000)
    We proposed at Sec.  488.1000 to set forth the statutory authority 
related to this set of regulations. Sections 1834(u)(5) and 1861(iii) 
of the Act would be the statutory basis for these regulations. These 
sections of the Act provide the Secretary with the authority necessary 
to carry out the administration of the Medicare program. Section 1861 
of the Act defines services, supplier types and benefits, and over whom 
Medicare may have authority. Section 1861(d) defines the term 
``supplier.'' Section 1834(u)(5) of the Act governs accreditation of 
home infusion therapy suppliers.
    Section 1861(iii)(3)(D)(i)(III) of the Act requires that home 
infusion therapy suppliers be accredited by an organization designated 
under section 1834(u)(5) of the Act. Section 1834(u)(5) of the Act 
requires that the Secretary establish factors in designating 
accrediting organizations and designate accrediting organizations to 
accredit suppliers furnishing home infusion therapy by January 1, 2021.
    Proposed Sec.  488.1000(a) would set forth the statutory authority 
for the accreditation of home infusion therapy suppliers by the home 
infusion therapy AOs. Title 42 CFR 488.1000(b) would set forth the 
scope of the regulation, which is the application and reapplication 
procedures for national AOs seeking approval or re-approval of 
authority to accredit home infusion therapy suppliers; ongoing CMS 
oversight processes for approved of home infusion therapy AOs; and, 
appeal procedures for AOs of home infusion therapy suppliers.
(2) Definitions (Sec.  488.1005)
    We proposed the following definitions:
     ``Accredited home infusion therapy supplier'' means a 
supplier that has demonstrated substantial compliance with a CMS-
approved national home infusion therapy AO's applicable CMS-approved 
home infusion therapy accreditation program standards, which meet or 
exceed those of Medicare, and has been awarded accreditation by that 
AO.
     ``Qualified home infusion therapy supplier'' means an 
entity that meets the following criteria which are set forth at 
1861(iii)(3)(D)(i): (1) Furnishes infusion therapy to individuals with 
acute or chronic conditions requiring administration of home infusion 
drugs; (2) ensures the safe and effective provision and administration 
of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; (3) is 
accredited by an organization designated by the Secretary pursuant to 
section 1834(u)(5); and (4) meets such other requirements as the 
Secretary determines appropriate.
     ``Immediate jeopardy'' means a situation in which the 
provider's or supplier's non-compliance with one or more Medicare 
accreditation requirements has caused, or is likely to cause, serious 
injury, harm, impairment, or death to a patient, as codified at Sec.  
488.1.
     ``National accrediting organization'' means an 
organization that accredits supplier entities under a specific program 
and whose accredited supplier entities under each program are widely 
dispersed geographically across the United States. In addition, the 
specific program is active, fully implemented, and operational. This 
definition is codified at Sec.  488.1.
     ``Reasonable assurance'' means an AO has demonstrated to 
CMS' satisfaction that its accreditation program requirements meet or 
exceed the Medicare program requirements. This definition is codified 
at Sec.  488.1.
     ``Rural'' area means an area as defined at section 
1886(d)(2)(D) of the Act.
     ``Substantial allegation of non-compliance'' means a 
complaint from any of a variety of sources (such as patient, relative, 
or third party), including complaints submitted in person, by 
telephone, through written correspondence, or in the newspaper, 
magazine articles or other media, that will, if found to be present, 
adversely affect the health and safety of patients and raises doubts as 
to a supplier's compliance with any of the Medicare home infusion 
therapy accreditation requirements. This definition is codified at 
Sec.  488.1.
(3) Application and Reapplication Procedures for National Accrediting 
Organizations (Sec.  488.1010)
    Proposed Sec.  488.1010 would contain application and re-
application procedures for all national AOs seeking CMS-approval of an 
accreditation program for home infusion therapy suppliers. Proposed 
Sec.  488.1010(a) would provide a comprehensive listing of the 
information, supporting documentation, certifications, written 
statements and other data that prospective AOs for home infusion 
therapy suppliers would be required to include in their application for 
approval to accredit home infusion therapy suppliers. The proposed 
requirements under this section would apply to both initial 
applications for CMS-approval as well as applications for re-approval 
of an

[[Page 56571]]

existing CMS-approved home infusion therapy accreditation program. This 
proposed provision would also require the AOs for home infusion therapy 
supplies to furnish CMS with information that demonstrates that their 
accreditation program requirements meet or exceed the applicable 
Medicare requirements.
    Proposed Sec.  488.1010(a)(1) requires AOs for home infusion 
therapy suppliers seeking initial or renewed CMS-approval of their home 
infusion therapy accreditation program to demonstrate that they meet 
the definition of a ``national accrediting organization.'' Section 1865 
of the Act requires that accrediting organizations be national in 
scope.
    Proposed Sec.  488.1010(a)(2) requires AOs to specifically identify 
the Medicare supplier type for which they are requesting CMS-approval 
or reapproval.
    Proposed Sec.  488.1010(a)(3) requires AOs to demonstrate their 
ability to take into account the capacities of home infusion therapy 
suppliers in rural areas (as defined in section 1834(u)(5)(A)(ii) of 
the Act.
    Proposed Sec.  488.1010(a)(4) requires the home infusion therapy AO 
to provide information that documents their knowledge, expertise, and 
experience in the healthcare field for which they offer accreditation 
and for which they are requesting approval.
    Proposed Sec.  488.1010(a)(5) requires the AO to submit a detailed 
crosswalk (in table format) that identifies, for each of the applicable 
Medicare health and safety requirements, the exact language of the 
accrediting organization's comparable accreditation requirements and 
standards. This proposed requirement would allow CMS to evaluate 
whether the accreditation program standards meet or exceed the 
applicable Medicare requirements.
    Proposed Sec.  488.1010(a)(6) requires each AO for home infusion 
therapy suppliers to provide a detailed description of its survey 
process. This requirement is intended to allow CMS to gain a better 
understanding of an AO's survey process and ensure that its survey and 
enforcement processes are comparable to Medicare's health and safety 
standards (contained in 42 CFR part 486, subpart I).
    Proposed Sec.  488.1010(a)(7)(ii) requires home infusion therapy 
AOs that use offsite audits, or other evaluation strategies to evaluate 
the quality of services provided by a home infusion therapy supplier, 
to follow up these offsite audits with periodic onsite visits. We 
believe that it is very important for the AOs that accredit home 
infusion therapy suppliers to follow-up off-site survey reviews with 
periodic on-site visits to ensure that the home infusion therapy 
supplier is complying with all accreditation standards and meeting all 
health and safety regulations.
    We proposed at Sec.  488.1010(a)(8), to require an AO for home 
infusion therapy suppliers to provide a description of the criteria for 
determining the size and composition of the onsite survey or offsite 
audit teams or teams used for other accreditation evaluation 
strategies.
    We proposed at Sec.  488.1010(a)(9) to require that an AO for home 
infusion therapy suppliers provide CMS with information regarding the 
overall adequacy of the number of surveyors, auditors, and other staff 
available to perform all survey related activities. Under this section, 
the home infusion therapy AO would also be required to provide an 
explanation as to how it will maintain an adequate number of trained 
surveyors on staff. The home infusion therapy AO must also describe its 
ability to increase the size of survey, audit, and other survey program 
staff to match growth in the number of accredited home infusion therapy 
suppliers while maintaining re-accreditation intervals for existing 
accredited home infusion therapy suppliers.
    We proposed at Sec.  488.1010(a)(10) to require that an AO for home 
infusion therapy suppliers provide CMS with detailed information about 
the individuals who perform survey activities, including onsite 
surveys, offsite audits and other review processes, for the purpose of 
ensuring accredited home infusion therapy suppliers maintain adherence 
to the accreditation program requirements.
    Proposed Sec.  488.1010(a)(11) requires each AO for home infusion 
therapy suppliers to describe the content, frequency and types of in-
service training provided to survey and audit personnel.
    We proposed at Sec.  488.1010(a)(12) to require AOs for home 
infusion therapy suppliers to provide documentation which describes the 
evaluation systems used to monitor the performance of individual 
surveyors, survey teams, and staff that perform audit activities. This 
requirement will provide CMS with insight into how each home infusion 
therapy AO measures the performance of their surveyors, survey teams 
and staff that perform audit activities.
    We proposed at Sec.  488.1010(a)(13) to require the AO for home 
infusion therapy suppliers to provide the organization's policies and 
procedures for avoiding and handling conflicts of interest, including 
the appearance of conflicts of interest, involving individuals who 
conduct surveys, audits or participate in accreditation decisions.
    Proposed Sec.  488.1010(a)(14) requires the AO for home infusion 
therapy suppliers to provide CMS with documentation of its policies and 
procedures for handling disputes filed by a home infusion therapy 
supplier regarding survey or audit findings, or an adverse decision.
    We proposed at Sec.  488.1010(a)(15) requires that home infusion 
therapy AOs provide CMS with copies of the policies and procedures to 
be used when an accredited home infusion therapy supplier either--(1) 
removes or ceases furnishing services for which they are accredited; or 
(2) adds home infusion therapy services for which they are not 
accredited.
    We proposed at Sec.  488.1010(a)(16) to require the home infusion 
therapy AOs to provide CMS with the organization's policies and 
procedures for responding to and investigating complaints and 
grievances against accredited suppliers.
    We proposed at Sec.  488.1010(a)(17) to require that the home 
infusion therapy AOs furnish a description of the AO's accreditation 
status decision-making process.
    We proposed at Sec.  488.1010(a)(18) to require a home infusion 
therapy AOs to provide CMS with a list of all home infusion therapy 
suppliers currently accredited by that home infusion therapy AO.
    We proposed at Sec.  488.1010(a)(19) to require that the home 
infusion therapy AOs provide CMS with a schedule of all survey activity 
(including but not limited to onsite surveys, offsite audits and other 
types if survey strategies), expected to be conducted by the home 
infusion therapy AO during the 6-month period following submission of 
the application.
    We proposed at Sec.  488.1010(a)(20) to require that the home 
infusion therapy AO submit a written statement or document that 
demonstrates the organization's ability to furnish CMS with the 
electronic data the home infusion therapy AO must report to CMS as 
required by proposed Sec.  488.1035.
    We proposed at Sec.  488.1010(a)(21) to require that the home 
infusion therapy AO provide a description of the organization's data 
management and analysis system with respect to its surveys and 
accreditation decisions.
    We proposed at Sec.  488.1010(a)(22) to require the home infusion 
therapy AO to furnish the three most recent annual

[[Page 56572]]

audited financial statements from their organization.
    We proposed at Sec.  488.1010(a)(23) to require the home infusion 
therapy AOs to provide a written statement, in which the home infusion 
therapy AO acknowledges, as a condition for approval, that the 
organization agrees to the items set forth in Sec.  488.1010(a)(23)(i) 
through (vi).
    Proposed Sec.  488.1010(a)(23)(i) requires the home infusion 
therapy AO to provide a written statement acknowledging that, as a 
condition for approval, that if the home infusion therapy AO decides to 
voluntarily terminate its accreditation program, the home infusion 
therapy AO must provide written notification to CMS and all home 
infusion therapy suppliers accredited by that AO. This written notice 
must be provided at least 180 calendar days in advance of the effective 
date of the home infusion therapy AOs decision to voluntarily terminate 
its CMS-approved accreditation program.
    Proposed Sec.  488.1010(a)(24) requires the home infusion therapy 
AOs to provide CMS with a listing of the organization's fees for home 
infusion therapy accreditation. The home infusion therapy AO must 
notify CMS of any plans for reducing the burden and cost of 
accreditation to small or rural home infusion therapy suppliers. While 
CMS does not undertake to set or regulate the fees charges by a home 
infusion therapy AO, we do review fees charged by AOs to determine 
whether they are reasonable as directed by sections 1834(u)(5)(A)(iii) 
of the Act.
    Proposed Sec.  488.1010(b) requires home infusion therapy AOs to 
agree to submit any additional information, documentation, or 
attestations, including items not previously listed that CMS may deem 
necessary to make a determination for approval or denial of the home 
infusion therapy AO's application. Should we require this additional 
information, we would notify the home infusion therapy AO of the 
request and provide the home infusion therapy AO with a reasonable 
timeframe to submit the requested information.
    We proposed at Sec.  488.1010(c) to allow a home infusion therapy 
AO to withdraw its initial application for CMS's approval of its home 
infusion therapy accreditation program at any time before we publish 
the final Federal Register notice described at proposed Sec.  
488.1020(b). Proposed Sec.  488.1020(b) requires that the final notice, 
published by CMS, specify the basis for our decision.
    Proposed Sec.  488.1010(d) requires CMS to complete its review of 
an application submitted by a home infusion therapy AO within 210 
calendar days from the date that CMS determines that the application is 
complete. We proposed that to determine completeness, each application 
would be assigned to a technical review team upon receipt by CMS.
    We sought public comment on the application requirements set forth 
in Sec.  488.1010. We further sought comments on the burden related to 
the requirements of the application procedure. We received the 
following public comments:
    Comment: Several commenters expressed general concern about the 
time and cost burden that would be incurred by a home infusion therapy 
AO related to obtaining CMS approval for their accreditation program. 
Another commenter questioned what the additional time and cost burden 
to home infusion therapy AOs for the ongoing administration of their 
home infusion therapy accreditation program, after CMS approval is 
obtained.
    Response: While we understand that there would be some time and 
cost burden associated with the accreditation process for home infusion 
therapy AOs, this burden is necessary because the CMS approval process 
is required by section 1834(u)(5)(B) of the Act which requires the 
Secretary to designate AOs to accredit home infusion therapy suppliers 
furnishing home infusion therapy not later than January 1, 2021.
    Comment: Several home infusion therapy suppliers expressed concern 
that the additional or increased operational costs incurred by new of 
existing home infusion therapy AOs (such as training, staff wages, 
revision of accreditation standards to meet the new Medicare home 
infusion therapy health and safety standards, preparation of the 
application for CMS seeking CMS approval of the AOs home infusion 
therapy accreditation program meet new and/or different accreditation 
standards, etc.) are likely that these standards and associated costs 
will vary among AOs.
    Response: While we understand that there would be some time and 
cost burden associated with the accreditation process for home infusion 
therapy AOs, this burden is necessary because the CMS approval process 
is required by section 1834(u)(5)(B) of the Act which requires the 
Secretary to designate AOs to accredit home infusion therapy suppliers 
furnishing home infusion therapy not later than January 1, 2021.
    Comment: Several commenters urged CMS to amend proposed Sec.  
488.1010(a)(23)(i) to require an AO to provide home infusion therapy 
suppliers with a 180 day notice, rather than a 90 day notice of the 
AO's voluntary withdrawal from the CMS accreditation program. These 
commenters stated the belief that the 90 day notice requirement would 
be too short a period of time for an otherwise compliant home infusion 
therapy supplier to secure new accreditation from a different CMS-
approved home infusion therapy AO.
    Response: We believe that, in most cases, an home infusion therapy 
AO that has decided to voluntarily terminate their CMS-approved home 
infusion therapy accreditation program is likely make this decision at 
least 6 months prior to the date that they would completely cease 
operations, in order to give them time to wrap up their business 
affairs and wind down operations. For example, the AO would need to 
complete any surveys that had been scheduled or refer these clients to 
other AOs. They would also need to provide notice to their accredited 
home infusion therapy suppliers of their decision to voluntarily 
terminate their CMS-approved home infusion therapy accreditation 
program.
    We agree with these commenters that the 90 day notice period may 
not be a sufficient period of time in which an otherwise compliant home 
infusion therapy provider could seek out another CMS-approved home 
infusion therapy AO, file the required application, and complete the 
accreditation process. Therefore, we have decided to increase the 
notice requirement specified in Sec.  488.1010(a)(23)(i) from 90 days 
to 180 days as requested.
    It is important to note that Sec.  488.1010(a)(23) requires the 
home infusion therapy AOs to provide a written statement in their 
application to CMS, in which the home infusion therapy AO acknowledges, 
as a condition for approval, that the organization agrees to the items 
set forth in Sec.  488.1010(a)(23)(i) through (vi). However, the actual 
requirement that the home infusion therapy AO provide notice is set 
forth at Sec.  488.1045(a). Since we will be increasing the notice 
requirement that is to be included in the statement that is to be 
provided in the application submitted by the home infusion therapy AO 
as a condition for approval as required by Sec.  488.1010(a)(23)(i), we 
must also make a corresponding change to the notice requirement in 
Sec.  488.1045(a).
    Final Decision: Section 488.1010(23)(a)(i) will be amended by 
changing the notice requirement for home infusion therapy AOs that 
voluntarily terminate their CMS-approved accreditation program from 90 
days to 180 days. This change requires that we also make a 
corresponding

[[Page 56573]]

change to the notice requirement of Sec.  488.1045(a). (See the 
discussion of Sec.  488.1045(a) in this final rule with comment period) 
for this corresponding change.
(4) Resubmitting a Request (Sec.  488.1015)
    Proposed Sec.  488.1015(a) requires that except as provided in 
paragraph (b), a home infusion therapy AO whose request for CMS' 
approval or re-approval of a home infusion therapy accreditation 
program was denied, or an organization that has voluntarily withdrawn 
an initial application, could resubmit its application if the 
organization had: (1) Revised its accreditation program to address the 
issues related to the denial of its previous request or its voluntary 
withdrawal; and (2) resubmitted the application in its entirety.
    Proposed Sec.  488.1015(b) provides that a home infusion therapy AO 
that has requested reconsideration of an application denial by CMS 
could not submit a new application until the pending reconsideration 
was administratively final. This proposed provision would ensure that 
review of accreditation matters on reconsideration are pending before 
only one administrative agency and one administrative level at a time.
    We sought public comments on the requirements of Sec.  488.1015. We 
did not receive any comments regarding Sec.  488.1015.
    Final Decision: Having received no comments in regards to Sec.  
488.1015, this section will be finalized as drafted, without 
modification.
(5) Public Notice and Comment (Sec.  488.1020)
    Proposed Sec.  488.1020(a) requires CMS to publish a notice in the 
Federal Register upon receipt of a complete application package. The 
notice would identify the organization, the type of home infusion 
therapy suppliers covered by the accreditation program, and provides 
for at least a 30-day public comment period (which begins on the date 
of publication of the Federal Register notice). The purpose of the 
Federal Register notice is to notify the public that a national AO has 
filed an application for approval of a home infusion therapy 
accreditation program and to seek public comment in response to this 
application. The requirement for the publication of a notice in the 
Federal Register when an application is received is an existing 
regulatory procedural requirement for all other AO types. We have added 
this requirement to the home infusion therapy AO approval and oversight 
regulations for consistency, and because we believe that it is 
important for the public to have notice of accreditation organization 
activities.
    Section 488.1020(b) requires that when CMS approves or re-approves 
an application for approval of a home infusion therapy AO's 
accreditation program, a final notice will be published in the Federal 
Register. This notice would have to specify the basis for CMS' 
decision. Section 488.1020(b)(1), requires that our final notice 
include at a minimum, the following information: (1) How the 
accreditation program met or exceeded Medicare accreditation program 
requirements; (2) the effective date of the CMS approval, which is not 
later than the publication date of the notice; and (3) the term of the 
approval (6 years or less).
    If CMS makes a decision to disapprove a home infusion therapy AOs 
application, our final notice would state the deficiencies found in the 
application and the reason why the AOs accreditation program did not 
met or exceeded Medicare accreditation program requirements. However, 
an AO has the option of voluntarily withdrawing its application at any 
time up until the publication of the final notice.
    We proposed at Sec.  488.1020(b)(2) that if CMS did not approve a 
home infusion therapy AO's application for approval of its home 
infusion therapy accreditation program, the final notice would explain 
how the home infusion therapy AO failed to meet Medicare home infusion 
therapy accreditation program requirements. This notice would indicate 
the effective date of the decision.
    We sought comment on the requirements of Sec.  488.1020, including 
on the appropriate term for approval of an AO. We did not receive any 
comments regarding Sec.  488.1020.
    Final Decision: Having received no comments in regards to Sec.  
488.1020, this section will be finalized as drafted, without 
modification.
(6) Release and Use of Accreditation Surveys (Sec.  488.1025)
    Proposed Sec.  488.1025 requires a home infusion therapy AO to 
include, in its accreditation agreement with each home infusion therapy 
supplier, an acknowledgement that the home infusion therapy supplier 
agrees to release to CMS a copy of its most current accreditation 
survey and any information related to the survey that CMS may require, 
including the home infusion therapy supplier's corrective action plans. 
Proposed Sec.  488.1025(a) provides that CMS may determine that a home 
infusion therapy supplier does not meet the applicable Medicare 
conditions or requirements on the basis of its own investigation of the 
accreditation survey or any other information related to the survey.
    Proposed Sec.  488.1025(b) prohibits CMS from disclosing home 
infusion therapy survey reports or survey related information according 
to section 1865(b) of the Act. However, CMS would be permitted to 
publicly disclose an accreditation survey and information related to 
the survey, upon written request, to the extent that the accreditation 
survey and survey information is related to an enforcement action taken 
by CMS.
    CMS would use the home infusion therapy supplier accreditation 
survey information for purposes such as: (1) Confirmation of the home 
infusion therapy supplier's eligibility for Medicare participation; (2) 
to review and approve the home infusion therapy AO's recommendations 
regarding accreditation; (3) to review the home infusion therapy AO's 
investigations of complaints; and (4) to review the corrective action 
taken by the AO when deficiencies are found on survey.
    We sought public comments on the requirements of Sec.  488.1025. We 
did not receive any comments regarding Sec.  488.1025.
    Final Decision: Having received no comments in regards to Sec.  
488.1025, this section will be finalized as drafted, without 
modification.
(7) Ongoing Review of Accrediting Organizations (Sec.  488.1030)
    Proposed Sec.  488.1030 clarifies that a formal accreditation 
program review could be opened on an ongoing basis. Specifically, this 
proposed section would describe standardized requirements related to 
the ongoing federal review of home infusion therapy AOs and their 
approved accreditation programs. This proposed section would clarify 
that CMS oversight of accreditation programs is consistent across home 
infusion therapy AOs. We are committed to treating all home infusion 
therapy AOs subject to our oversight in the same manner. Under proposed 
Sec.  488.1030, we could conduct the following three types of reviews 
of an AO's home infusion therapy accreditation programs: (1) 
Performance review; (2) comparability review; and (3) CMS-approved 
accreditation program review.
    Proposed Sec.  488.1030(a) allows CMS to perform a performance 
review, in which we would evaluate the performance of each CMS-approved 
home infusion

[[Page 56574]]

therapy accreditation program on an ongoing basis. Specifically, we 
would review the following aspects of a home infusion therapy AO's for 
home infusion therapy program performance: The organization's survey 
activity, and the organization's continued fulfillment of the 
requirements stated in Sec.  488.1010.
    Proposed Sec.  488.1030(b) allows CMS to perform a comparability 
review to assess the equivalency of a home infusion therapy AO's CMS-
approved home infusion therapy accreditation program requirements with 
comparable Medicare home infusion therapy accreditation requirements. 
Proposed Sec.  488.1030(b)(1) allows CMS to perform a comparability 
review when CMS imposes new or revised Medicare accreditation 
requirements. When this occurs, proposed Sec.  488.1030(b)(1) requires 
CMS to provide written notice to the home infusion therapy AOs when 
changes have been made to the Medicare home infusion therapy 
accreditation requirements. Proposed Sec.  488.1030(b)(2) requires the 
home infusion therapy accrediting organization to make revision to its 
home infusion therapy accreditation standards or survey process so as 
to incorporate the new or revised Medicare accreditation requirements.
    Proposed Sec.  488.1030(b)(3) would further require that the 
written notice sent by CMS to the home infusion therapy AO specify a 
deadline (not less than 30 days) by which the home infusion therapy AO 
must prepare and submit their home infusion therapy accreditation 
program requirement revisions and the timeframe for implementation. 
Proposed Sec.  488.1030(b)(4) would allow a home infusion therapy AO to 
submit a written request for an extension of the submission deadline as 
long as this request was submitted prior to the original deadline.
    Proposed at Sec.  488.1030(b)(5) requires that, after completing 
the comparability review, CMS would provide written notification to the 
home infusion therapy AO, specifying whether or not their revised home 
infusion therapy accreditation program standards continued to meet or 
exceed all applicable Medicare requirements. We propose at Sec.  
488.1030(b)(6) that if, no later than 60 days after receipt of the home 
infusion therapy AO's accreditation standard changes, CMS did not 
provide the written notice to the home infusion therapy AO, then the 
revised home infusion therapy program accreditation standards would be 
deemed to meet or exceed all applicable Medicare requirement and the 
accreditation program will have continued CMS-approval without further 
review or consideration.
    Proposed Sec.  488.1030(b)(7) provide that if a home infusion 
therapy AO was required to submit a new application because CMS imposed 
new regulations or made significant substantive revisions to the 
existing regulations, CMS would provide notice of the decision to 
approve or disapprove the application within the time period specified 
in proposed Sec.  488.1010(d).
    We proposed at Sec.  488.1030(b)(8) that if a home infusion therapy 
AO failed to submit its changes within the required timeframe, or 
failed to implement the changes that had been determined by CMS to be 
comparable, CMS could open an accreditation program review in 
accordance with Sec.  488.1030(d).
    When a home infusion therapy AO proposes to adopt new home infusion 
therapy accreditation standards or changes, in its survey process, we 
proposed at Sec.  488.1030(c)(1) to require the home infusion therapy 
AO to provide notice to CMS no less than 60 days prior to the planned 
implementation date of the changes. Proposed Sec.  488.1030(c)(2) 
prohibits the home infusion therapy AO from implementing these changes 
before receiving CMS' approval except as provided in proposed Sec.  
488.1030(c)(4). Proposed Sec.  488.1030(c)(3) requires that this 
written notice contain a detailed description of the changes to be made 
to the organization's home infusion therapy accreditation standards, 
including a detailed crosswalk (in table format) that states the exact 
language of the revised accreditation requirements and the 
corresponding Medicare requirements for each. The requirements of 
proposed Sec. Sec.  488.1030(c)(2) and 488.10(c)(3) ensures that the 
home infusion therapy AO provides CMS with advance notice of any 
changes to their home infusion therapy accreditation requirements and 
survey processes. This notice would allow CMS time to review these 
changes to ensure that the revised home infusion therapy accreditation 
standards and survey processes continue to meet or exceed all 
applicable Medicare home infusion therapy requirements and continue to 
be comparable to all applicable Medicare home infusion therapy survey 
processes, and provide a response to the home infusion therapy AO. This 
proposed section would also prohibit home infusion therapy AOs from 
implementing any of the changes in their home infusion therapy 
accreditation requirements and survey processes, until CMS approval has 
been received.
    Proposed Sec.  488.1030(c)(4) requires CMS to provide written 
notice to the home infusion therapy accrediting organization indicating 
whether the home infusion therapy accreditation program, including the 
revisions, continued or does not continue to meet or exceed all 
applicable Medicare home infusion therapy requirements. If CMS found 
that the accrediting organization's home infusion therapy accreditation 
program, including the revisions did not continue to meet or exceed all 
applicable Medicare home infusion therapy requirements. CMS would have 
to state the reasons for these findings.
    Section 488.1030(c)(5) requires CMS to provide this written notice 
to the home infusion therapy AO by the 60th calendar day following 
receipt of the home infusion therapy AO's written changes as to whether 
the home infusion therapy AO's revised home infusion therapy 
accreditation program standards and survey processes have been be 
deemed to meet or exceed all applicable Medicare home infusion therapy 
requirements and have continued CMS approval without further review or 
consideration. This proposed section would further specify that if CMS 
failed to provide the required written notice to the home infusion 
therapy AO by the 60-day deadline, the home infusion therapy AO's 
revised accreditation program standards would be deemed to meet or 
exceed all applicable Medicare requirements and have continued CMS 
approval without further review or consideration.
    Proposed Sec.  488.1030(c)(5) permits CMS to open an accreditation 
program review, in accordance with Sec.  488.1030(d), if a home 
infusion therapy AO implemented changes to their home infusion therapy 
accreditation requirements or survey process that were not determined 
nor deemed by CMS to be comparable to the applicable Medicare 
requirements.
    We proposed at Sec.  488.1030(d) to permit CMS to initiate an 
accreditation program review when a comparability or performance review 
reveals evidence that a home infusion therapy AO's CMS-approved home 
infusion therapy accreditation program is in substantial non-compliance 
with the requirements of the home infusion therapy health and safety 
regulations contained in 42 CFR part 486, subpart B. Proposed Sec.  
488.1030(d)(1) requires CMS to provide written notice to the home 
infusion therapy AO when a home infusion therapy accreditation program 
review is initiated. Proposed Sec.  488.1030(d)(1)(i) through (iv) set 
forth the requirements for this written notice,

[[Page 56575]]

which should contain the following information: (i) A statement of the 
instances, rates or patterns of non-compliance identified, as well as 
other related information, if applicable; (ii) a description of the 
process to be followed during the review, including a description of 
the opportunities for the home infusion therapy AO to offer factual 
information related to CMS' findings; (iii) a description of the 
possible actions that may be imposed by CMS based on the findings of 
the accreditation program review; and (iv) the actions the home 
infusion therapy AO will have to take to address the identified 
deficiencies, and the length of the accreditation program review 
probation period, which would include monitoring of the home infusion 
therapy AO's performance and implementation of the corrective action 
plan. The probation period is not to exceed 180 calendar days from the 
date that CMS has approved the home infusion therapy AOs plan of 
correction (which is the AO written plan for correcting any 
deficiencies in its home infusion therapy accreditation program that 
were found by CMS on a program review).
    At Sec.  488.1030(d)(2), we proposed that CMS reviews and approves 
the home infusion therapy AO's plan of correction for acceptability 
within 30 days after receipt. Proposed Sec.  488.1030(d)(3) provides 
that CMS monitors the implementation of the home infusion therapy 
accrediting organization's plan of correction for a period not to 
exceed 180 days from the date of approval. During the 180-day review 
period, CMS monitors implementation of the accepted plan of correction 
as well as progress towards correction of identified issues and areas 
of non-compliance that triggered the accreditation program review.
    We proposed at Sec.  488.1030(d)(4) to authorize CMS to place the 
home infusion therapy AO's CMS-approved accreditation program on 
probation for a subsequent period of up to 180 calendar days, if 
necessary. The additional period of time may be necessary if CMS 
determines, as a result of the home infusion therapy accreditation 
program review or a review of an application for renewal of an existing 
CMS-approved accreditation program, that the home infusion therapy AO 
has failed to meet any of the requirements of proposed Sec.  488.1010, 
or has made significant progress correcting identified issues or areas 
of non-compliance, but requires additional time to complete full 
implementation of corrective actions or demonstrate sustained 
compliance. If a home infusion therapy AO's term of approval expires 
before the 180-day period is completed, the probationary period would 
be deemed to end upon the day of expiration of the home infusion 
therapy AO's term of approval. In the case of a renewal application 
where we have placed the home infusion therapy accreditation program on 
probation, we proposed that any approval of the applications must be 
conditional while the program remains on probation.
    If we place a home infusion therapy AO's accreditation program on 
probation, proposed Sec.  488.1030(d)(4)(i) requires CMS to issue a 
written determination to the home infusion therapy AO, within 60 
calendar days after the end of any probationary period. The written 
determination must state whether or not the CMS-approved home infusion 
therapy accreditation program continued to meet the requirements of 
this section and the reasons for the determination.
    If we determined that withdrawal of approval from a CMS-approved 
accreditation program was necessary, proposed Sec.  488.1030(d)(4)(ii) 
requires CMS to send written notice to the home infusion therapy AO 
which contained the following information: (1) Notice of CMS' removal 
of approval of the home infusion therapy AOs accreditation program; (2) 
the reason(s) for the removal; and (3) the effective date of the 
removal determined in accordance with Sec.  488.1030(d)(4)(ii).
    If CMS withdrew the approval of a home infusion therapy AO 
accreditation program, Sec.  488.1030(d)(4)(iii) requires CMS to 
publish a notice of its decision to withdraw approval of the 
accreditation program in the Federal Register. This notice will have to 
include the reasons for the withdrawal, and a notification that the 
withdrawal will become effective 60 calendar days after the date of 
publication in the Federal Register. The publication of this Federal 
Register notice is notice will be necessary to put interested 
stakeholders, such as the home infusion therapy suppliers that are 
accredited by the affected AO on notice about the withdrawal of CMS-
approval of their AO, because this will have an effect on the status of 
their accreditation.
    Proposed Sec.  488.1030(e) allows CMS to immediately withdraw the 
CMS approval of an home infusion therapy AO's home infusion therapy 
accreditation program, if at any time CMS makes a determination that 
the continued approval of that home infusion therapy accreditation 
program poses an immediate jeopardy to the patients of the entities 
accredited under the program; or the continued approval otherwise 
constitutes a significant hazard to the public health.
    We proposed at Sec.  488.1030(f) to mandate that any home infusion 
therapy AO whose CMS approval of its home infusion therapy 
accreditation program has been withdrawn must notify, in writing, each 
of its accredited home infusion therapy suppliers of the withdrawal of 
CMS approval and the implications for the home infusion therapy 
suppliers' payment status no later than 30 calendar days after the 
notice is published in the Federal Register. This proposed requirement 
would protect the home infusion therapy suppliers that have received 
their accreditation from a home infusion therapy AO that has had its 
CMS approval of their home infusion therapy accreditation program 
removed.
    We sought public comments on the requirements and the burden 
associated with the requirements of Sec.  488.1030.
    We did not receive any comments related to the burden associated 
with requirements Sec.  488.1030. However, we did receive the following 
comment related to the requirements of Sec.  488.1030:
    Comment: Several commenters have requested that CMS clarify that 
the non-compliance that triggers a review under Sec.  488.1030 must not 
only be ``substantial'' but also be ``material.''
    Response: The term ``substantial'' means ``of considerable 
importance, size or worth.'' The term ``material'' means ``important, 
relevant or essential.'' \80\ We believe that these terms are similar 
enough in nature that adding the word ``material'' would be 
duplicative. Our goal, as stated in the proposed rule, is to make the 
AO approval and oversight regulations as consistent, as possible, with 
the AO approval and oversight regulations for Medicare-certified 
providers and suppliers at 42 CFR 488.5 to 488.13. The term 
``substantial and material'' is not used in regulation Sec.  488.8 
titled ``Ongoing review of accrediting organizations.'' which is the 
comparable regulation to Sec.  488.1030 regulations for Medicare-
certified providers and suppliers. Therefore, we believe that to add a 
different standard for home infusion therapy AOs would be inconsistent 
and would result in different standards across the AO types.
---------------------------------------------------------------------------

    \80\ Merriam Webster Online Dictionary.
---------------------------------------------------------------------------

    Also, many AOs have accreditation programs for numerous types of 
providers and suppliers. If CMS were to use varying standards for 
different types of providers and suppliers, it would make it difficult 
for these AOs with multiple accreditation programs to administer these 
programs in a smooth

[[Page 56576]]

and consistent manner. Therefore, we believe that it is important that 
CMS keep the language of Sec.  488.1030 consistent with that of Sec.  
488.8. We would also note that we have broad discretion to monitor the 
performance of AOs and to take action when necessary.
    Final Decision: After consideration on the comments received, we 
have decided to finalize Sec.  488.1030 without modification.
(8) Ongoing Responsibilities of a CMS-Approved Accreditation 
Organization (Sec.  488.1035)
    Proposed Sec.  488.1035 requires a home infusion therapy AO to 
provide certain information to CMS and carry out certain activities on 
an ongoing basis. More specifically Sec.  488.1035(a) requires the home 
infusion therapy AO to provide CMS with all of the following in written 
format (either electronic or hard copy):
     Copies of all home infusion therapy accreditation surveys, 
together with any survey-related information that CMS may require 
(including corrective action plans and summaries of findings with 
respect to unmet CMS requirements);
     Notice of all home infusion therapy accreditation 
decisions.
     Notice of all complaints related to home infusion therapy 
suppliers.
     Information about all home infusion therapy accredited 
suppliers against which the home infusion therapy AO has taken remedial 
or adverse action, including revocation, withdrawal, or revision of the 
home infusion therapy supplier's accreditation.
     Summary data specified by CMS that relate to the past 
year's home infusion therapy accreditation activities and trends which 
is to be provided on an annual basis.
     Notice of any changes in its home infusion therapy 
accreditation standards or requirements or survey process.
    Proposed Sec.  488.1035(b) requires a home infusion therapy AO to 
submit an acknowledgment of receipt of CMS' notification of a change in 
CMS requirements within 30 days from the date of the notice. Section 
488.1035(c) requires that a home infusion therapy AO permit its 
surveyors to serve as witnesses if CMS takes an adverse action based on 
accreditation findings.
    Proposed Sec.  488.1035(d) requires that within 2 business days of 
identifying a deficiency of an accredited home infusion therapy 
supplier that poses immediate jeopardy to a beneficiary or to the 
general public, the home infusion therapy AO must provide CMS with 
written notice of the deficiency and any adverse action implemented by 
the home infusion therapy AO. Section 488.1035(e) requires that within 
10 calendar days after our notice to a CMS-approved home infusion 
therapy AO that CMS intends to withdraw approval of the home infusion 
therapy AO, the home infusion therapy AO must provide written notice of 
the withdrawal to all of the organization's accredited home infusion 
therapy suppliers.
    We sought public comment on the requirements and the burden 
associated with Sec.  488.1035. We received no comments in regards to 
requirements and the burden associated with Sec.  488.1035.
    Final Decision: As no comments related to Sec.  488.1035 were 
received, this section to the proposed regulations will be finalized as 
drafted and without modifications.
(9) Onsite Observations of Accrediting Organization Operations (Sec.  
488.1040)
    We proposed at Sec.  488.1040(a) and (b) to permit CMS to conduct 
an onsite inspection of the home infusion therapy AOs operations and 
offices at any time to verify the organization's representations and to 
assess the organization's compliance with its own policies and 
procedures. Activities to be performed by CMS staff during the onsite 
inspections may include, but are not limited to: (1) Interviews with 
various home infusion therapy AO staff; (2) review of documents, and 
survey files, audit tools and related records; (3) observation of 
meetings concerning the accreditation process; (4) auditing meetings 
concerning the accreditation process; (5) observation of in-progress 
surveys and audits; (6) evaluation of the home infusion therapy AO's 
survey results and accreditation decision-making process.
    CMS would perform onsite visits to a home infusion therapy AOs 
offices only for specific reasons. For example, when an AO had filed an 
initial or renewal application for approval of its home infusion 
therapy accreditation program, CMS would perform an onsite visit to the 
AOs offices as part of the application review process. If CMS has 
opened a program review and put the home infusion therapy AO on 
probation for a 180 day period, we would perform an onsite visit to the 
AOs offices to check of the AOs progress in implementing the plan of 
correction.
    If CMS decides to perform on onsite visit to the home infusion 
therapy AOs offices, we would notify the AO. We would coordinate with 
the AO staff to schedule the onsite visit at mutually agreed upon date 
and time.
    The intended purpose of this proposed section is to provide CMS 
with an opportunity to observe, first hand, the daily operations of 
home infusion therapy AOs and to ensure that the home infusion therapy 
accreditation program is fully implemented and operational as presented 
in the written application. Onsite inspections would strengthen our 
continuing oversight of the home infusion therapy AO performance 
because they provide an opportunity for us to corroborate the verbal 
and written information submitted to CMS by the home infusion therapy 
AO in their initial and renewal applications. In addition, onsite 
inspections would allow CMS to assess the home infusion therapy AO's 
compliance with its own policies and procedures.
    We sought public comments on the requirements of and the burden 
related to Sec.  488.1040. However, we received no comments in regards 
to requirements and the burden associated with Sec.  488.1040.
    Final Decision: As no comments related to Sec.  488.1040 were 
received, this section to the proposed regulations will be finalized as 
drafted and without modifications.
(10) Voluntary and Involuntary Termination (Sec.  488.1045)
    The proposed provisions related to the voluntary and involuntary 
termination of CMS approval of a home infusion therapy AO's 
accreditation program are set out at Sec.  488.1045. Proposed Sec.  
488.1045(a) addresses voluntary termination of a home infusion therapy 
AO's accreditation program by the home infusion therapy AO. A home 
infusion therapy AO that decides to voluntarily terminate its CMS-
approved accreditation program must provide written notice to CMS and 
each of its accredited home infusion therapy suppliers at least 180 
days in advance of the effective date of the termination. This written 
notice must state the implications for the home infusion therapy 
supplier's payment should there be a lapse in their accreditation 
status.
    Proposed Sec.  488.1045(b) addresses CMS' involuntary termination 
of a home infusion therapy AO's CMS-approved accreditation program. 
Once CMS publishes the notice in the Federal Register announcing its 
decision to terminate the accrediting organization's home infusion 
therapy accreditation program, the home infusion therapy AO would have 
to provide written notification to all home infusion therapy suppliers 
accredited under its CMS-approved home infusion therapy accreditation 
program no later than 30 calendar days after the notice was published 
in the Federal Register. This

[[Page 56577]]

notice would state that CMS is withdrawing its approval of the home 
infusion therapy AO's accreditation program and the implications for 
their payment, should there be a lapse in their accreditation status.
    Proposed Sec.  488.1045(c) addresses the requirements that would 
apply to both voluntary and involuntary terminations of CMS approval of 
the home infusion therapy AO. Proposed Sec.  488.1045(c)(1) provides 
that the accreditation status of affected home infusion therapy 
suppliers will be considered to remain in effect until their current 
term of accreditation expired. In the case where a home infusion 
therapy AO has been removed as a CMS-approved AO, any home infusion 
therapy supplier that is accredited by the organization during the 
period beginning on the date the organization was approved by CMS until 
the date the organization was removed, shall be considered accredited 
for its remaining accreditation period.
    Proposed Sec.  488.1045(c)(2) provides that for any home infusion 
therapy supplier, whose home infusion therapy AO's CMS approval has 
been voluntarily or involuntarily terminated by CMS, and who wishes to 
continue to receive reimbursement from Medicare, must provide written 
notice to CMS at least 60-calendar days prior to its accreditation 
expiration date which states that the home infusion therapy supplier 
has submitted an application for accreditation under another CMS-
approved home infusion therapy accreditation program. This proposed 
section further states that failure to comply with this 60-calendar day 
requirement prior to expiration of their current accreditation status 
could result in a suspension of payment.
    Proposed Sec.  488.1045(c)(3) requires that the terminated home 
infusion therapy AO must provide a second written notification to all 
accredited suppliers 10 calendar days prior to the organization's 
accreditation program effective date of termination.
    The proposed notice provisions at Sec.  488.1045(c)(2) and (3) 
could help prevent home infusion therapy suppliers from suffering 
financial hardship that could result from a denial of payment of 
Medicare claims if their home infusion therapy accreditation lapses as 
a result of the voluntary or involuntary termination of a CMS-approved 
home infusion therapy AO program.
    We proposed at Sec.  488.1045(d), that if a home infusion therapy 
supplier requests a voluntary withdrawal from accreditation, it will 
not be possible for the withdrawal to become effective until the home 
infusion therapy AO completes three required steps. First, the AO would 
have to contact the home infusion therapy supplier to seek written 
confirmation that the home infusion therapy supplier intended to 
voluntarily withdraw from the accreditation program. Second, the home 
infusion therapy AO would have to advise home infusion therapy 
supplier, in writing, of the statutory requirement at section 
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all 
home infusion therapy suppliers. Third, the home infusion therapy AO 
would have to advise the home infusion therapy supplier of the possible 
payment consequence for a lapse in accreditation status. Section 
488.1045(d)(3) requires the home infusion therapy AO to submit their 
final notice of the voluntary withdrawal of accreditation by the home 
infusion therapy supplier 5 business days after the request for 
voluntary withdrawal was ultimately processed and effective.
    We believe that it is important that the home infusion therapy seek 
confirmation that the home infusion therapy supplier has indeed 
requested a voluntary termination of their accreditation. This 
confirmation would prevent the erroneous termination of the 
accreditation of a home infusion therapy supplier that did not request 
it or had subsequently withdrawn their request for voluntary 
termination.
    We believe that it is also important for the home infusion therapy 
AO to provide the required written notice to the home infusion therapy 
supplier that requests a voluntary withdrawal from accreditation, so 
that the home infusion therapy supplier has been fully informed of the 
requirements for accreditation according to section 
1861(iii)(3)(D)(i)(III) of the Act and the payment consequences of 
being unaccredited. If there is a lapse in the accreditation status of 
the home infusion therapy supplier, they would not be eligible to 
receive payment from Medicare for services furnished to Medicare 
beneficiaries. A home infusion therapy infusion therapy supplier that 
is unaware of this payment consequence could suffer financial hardship 
due to furnishing services to Medicare beneficiaries for which they 
cannot be reimbursed after a lapse in accreditation.
    We solicited public comments on the requirements of and the burden 
related to Sec.  488.1045.
    Comment: A commenter expressed concern that the requirements of 
proposed Sec.  488.1045(d) would be extremely burdensome for the home 
infusion therapy AO to implement. This section provides that if a home 
infusion therapy supplier requested a voluntary withdrawal from 
accreditation, it would not be possible for the withdrawal to become 
effective until the home infusion therapy AO completed the following 
three required steps: (1) The AO must contact the home infusion therapy 
supplier to seek written confirmation that the home infusion therapy 
supplier intended to voluntarily withdraw from the accreditation 
program; (2) the home infusion therapy AO must to advise home infusion 
therapy supplier, in writing, of the statutory requirement at 
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all 
home infusion therapy suppliers; and (3) the home infusion therapy AO 
must advise the home infusion therapy supplier of the possible payment 
consequence for a lapse in accreditation status. Proposed Sec.  
488.1045(d)(3) would require the home infusion therapy AO to submit 
their final notice of the voluntary withdrawal of accreditation by the 
home infusion therapy supplier 5 business days after the request for 
voluntary withdrawal was ultimately processed and effective.
    In support of this contention that the previous requirements would 
be too burdensome, the commenter stated the belief that the home 
infusion therapy supplier would be responsible for knowing the CMS 
rules of coverage. AO's should provide this information to the supplier 
in the form of the AO's accreditation process and/or procedures. The AO 
should not have the burden of producing documentation that they 
informed the supplier at 3 separate times of what could happen if they 
withdrew their accreditation.
    Response: We disagree with this commenter's contention that the 
requirements of proposed Sec.  488.1045(d) are burdensome for the home 
infusion therapy AO to implement with the business technology that is 
readily available to each AO. It is important to point out that all 3 
of these previously discussed steps can be accomplished quickly and 
effectively and would take a relatively short period of time. We say 
this because this section merely requires that each of the 3 categories 
of information is obtained and disseminated to the home infusion 
therapy supplier. This section does not require them to be accomplished 
separately at different times or on different dates.
    Similarly, we believe that this task can be accomplished by the AO 
sending one single correspondence to the home infusion therapy supplier 
and simple follow-up monitoring to ensure that the

[[Page 56578]]

home infusion therapy supplier returns the required written 
confirmation to the AO acknowledging that they do intend to voluntarily 
withdraw from the accreditation program. To simplify matters further 
and save even more time, we believe that the AO could create a pre-
prepared home infusion therapy supplier notification letter and an 
acknowledgment of withdrawal from accreditation form in a fillable .pdf 
template format. Thereafter, when a home infusion therapy supplier 
notifies an AO that they are withdrawing from that AO, all the AO would 
need to do is open up the AO notification and home infusion therapy 
supplier acknowledgement templates on their computer, fill in the 
blanks on the fillable .pdf template forms, print the forms and send 
them HIT supplier via hand deliver, text, email, fax or U.S.P., federal 
Express, etc. Then AO would only have to await for the HIT supplier to 
return the signed acknowledgement form.
    Comment: Sec.  488.1045(c)(2) provides that if a home infusion 
therapy supplier, whose home infusion therapy AO's CMS approval has 
been voluntarily or involuntarily terminated by CMS wishes to continue 
to receive reimbursement from Medicare, that home infusion therapy 
supplier must provide written notice to CMS at least 60-calendar days 
prior to its accreditation expiration date which states that the home 
infusion therapy supplier has submitted an application for 
accreditation under another CMS-approved home infusion therapy 
accreditation program. This proposed section further states that 
failure to comply with this 60-calendar day requirement prior to 
expiration of their current accreditation status could result in a 
suspension of payment.
    Several commenters have urged CMS to amend the notice requirement 
of proposed Sec.  488.1045(c)(2). These commenters have requested that 
CMS decrease the minimum time period by which affected home infusion 
therapy suppliers must provide their written notice to CMS informing us 
that they have filed an application with another home infusion therapy 
AO from 60 days to 5 days prior to the effective date of the 
termination of the home infusion therapy suppliers current term of 
accreditation. These commenters stated the belief that the change to a 
5 day notice requirement will ensure that the second AO termination 
notice to providers can be acted upon if, for any reason, the original 
termination notice was missed.
    Response: We understand the concern on the part of home infusion 
therapy suppliers about possibly missing the first notice sent by their 
home infusion therapy AO when that AOs CMS-approval has been 
voluntarily or involuntarily withdrawn. We believe that in the event a 
home infusion therapy AO voluntarily or voluntarily has its CMS-
approval terminated, there will be ample notice provided.
    In the case of an involuntary termination of an AOs CMS approval, 
Sec.  488.1045(b) as finalized requires that CMS publish a notice in 
the Federal Register announcing its decision to terminate the 
accrediting organization's home infusion therapy accreditation program, 
therefore, the home infusion therapy AO will have to provide written 
notification to all home infusion therapy suppliers accredited under 
its CMS-approved home infusion therapy accreditation program no later 
than 30 calendar days after the notice is published in the Federal 
Register. This notice must state that CMS is withdrawing its approval 
of the home infusion therapy AO's accreditation program, and also 
discuss the implications for the supplier's payment, should there be a 
lapse in their accreditation status. In the case of a voluntary 
termination of an AO's CMS approval, proposed Sec.  488.1045(d) 
provides that it will not be possible for the withdrawal to become 
effective until the home infusion therapy AO completes three required 
steps: (1) The AO must contact the home infusion therapy supplier to 
seek written confirmation that the home infusion therapy supplier 
intends to voluntarily withdraw from the accreditation program; (2) the 
home infusion therapy AO must advise home infusion therapy supplier, in 
writing, of the statutory requirement at section 
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all 
home infusion therapy suppliers; and (3) the home infusion therapy AO 
must advise the home infusion therapy supplier of the possible payment 
consequence for a lapse in accreditation status. Furthermore, Sec.  
488.1045(d)(3) requires the home infusion therapy AO to submit a final 
notice of the voluntary withdrawal of accreditation by the home 
infusion therapy supplier 5 business days after the request for 
voluntary withdrawal is ultimately processed and effective.
    In addition to the notices required by the regulatory provisions 
previously referenced, CMS will take all appropriate steps to ensure 
that the affected home infusion therapy suppliers are given timely 
notice about the termination of their home infusion therapy AO's CMS-
approved home infusion therapy accreditation program. Some possible 
methods CMS would use to make this information available to these 
affected home infusion therapy suppliers include, but are not limited 
to posting of information on the Quality, Safety and Oversight Group 
(QSOG) web page, notification sent via email and email blasts, 
information published in the Medicare Learning Network newsletter, 
Medicare payment manual bulletin, newsletter and in Medicare Learning 
Network publications, and discussion during Open Door Forums.
    We believe that the requirement that affected home infusion therapy 
suppliers provide CMS with written notice that they have filed an 
application for accreditation with another CMS-approved home infusion 
therapy AO at least 60 days prior to the expiration of their current 
term of accreditation is an essential requirement for several reasons. 
First, it ensures CMS that all home infusion therapy suppliers affected 
by a voluntary or involuntary termination of a particular AO's CMS-
approved accreditation program have indeed filed applications with 
other CMS-approved home infusion therapy AOs in a timely manner.
    Second, the required 60 day written notice to be provided by these 
affected home infusion therapy suppliers informs CMS that they have 
already filed an application and initiated the accreditation process 
with another CMS-approved home infusion therapy AO. This in turn, will 
trigger the CMS payment system not to continuing paying these home 
infusion therapy suppliers until their new accreditation information is 
received.
    The requirement that written notice be submitted by all affected 
home infusion therapy suppliers at least 60 days prior to the 
expiration of their current terms of accreditation provides CMS with 
assurances that the accreditation process for each these affected home 
infusion therapy suppliers has already been initiated, is either 
substantially completed or will be completed prior to the expiration of 
the affected home infusion therapy suppliers current term of 
accreditation and that CMS can be assured that they are not going to be 
paying claims submitted by non-accredited home infusion therapy 
supplier.
    The accreditation process takes several months, at a minimum. If 
CMS were to allow these home infusion therapy suppliers to wait until 5 
days prior to the expiration date of their current term of 
accreditation to notify CMS that they have initiated the accreditation 
process (filed an application) with another AO, CMS would have no 
assurance that the

[[Page 56579]]

accreditation process will be completed or substantially completed by 
the time their current term of accreditation lapses. If this were the 
case, CMS would not be able to prevent a lapse in payment to these home 
infusion therapy suppliers that find themselves in the situation in 
which the CMS-approval of their AO has been withdrawn. Therefore, this 
requirement is intended to protect those otherwise compliant home 
infusion therapy suppliers, who find themselves, through no fault of 
their own, in the situation in which their current AO is no longer CMS-
approved.
    Final Decision: After consideration of the comments received, we 
have decided not to change the notification requirement set forth in 
Sec.  488.1045(c)(2). Therefore, we are finalizing the provisions of 
section Sec.  488.1045 without modification.
(11) Reconsideration (Sec.  488.1050)
    We proposed at Sec.  488.1050 to set forth the appeal process 
through which a home infusion therapy AO may request reconsideration of 
an unfavorable decision made by CMS. Proposed at Sec.  488.1050(b)(1), 
the home infusion therapy AO will have to submit a written request for 
reconsideration within 30 calendar days of the receipt of the CMS 
notification of an adverse determination or non-renewal. Proposed Sec.  
488.1050(b)(2) requires the home infusion therapy AOs to submit a 
written request for reconsideration which specifies the findings or 
issues with which the home infusion therapy AO disagreed and the 
reasons for the disagreement. Proposed Sec.  488.1050(b)(3) allows a 
home infusion therapy AO to withdraw their request for reconsideration 
at any time before the administrative law judge issues a decision.
    We proposed at Sec.  488.1050(c)(1) to establish requirements for 
CMS when a request for reconsideration has been received from a home 
infusion therapy AO. Specifically, CMS would be required to provide the 
home infusion therapy AO with: The opportunity for an administrative 
hearing with a hearing officer appointed by the Administrator of CMS; 
the opportunity to present, in writing and in person, evidence or 
documentation to refute CMS' notice of denial, termination of approval, 
or non-renewal of CMS approval and designation. Proposed Sec.  
488.1050(c)(2) requires CMS to send the home infusion therapy AO 
written notice of the time and place of the informal hearing at least 
10 business days before the scheduled hearing date.
    We proposed at Sec.  488.1050(d)(1) to establish rules for the 
administrative hearing such as who may attend the hearing on behalf of 
each party, including but not limited to legal counsel, technical 
advisors, and non-technical witnesses that have personal knowledge of 
the facts of the case. This proposed section would also specify the 
type of evidence that may be introduced at the hearing. Specifically, 
we would specify and clarify, at proposed Sec.  488.1050(d)(4), that 
the hearing officer would not have the authority to compel by subpoena 
the production of witnesses, papers, or other evidence. Proposed Sec.  
488.1050(d)(5) provides that the legal conclusions of the hearing 
officer within 45 calendar days after the close of the hearing. 
Proposed Sec.  488.1050(d)(6) requires the hearing officer to present 
his or her findings and recommendations in a written report that 
includes separately numbered findings of fact. According to proposed 
Sec.  488.1050(d)(7), the decision of the hearing officer would be 
final.
    We sought public comments on the requirements of Sec.  488.1050. We 
received no comments on the requirements of Sec.  488.1050.
    Final Decision: Having received no comments in regards to Sec.  
488.1050, we are finalizing this provision without modification.

D. Payment for Home Infusion Therapy Services

1. Temporary Transitional Payment for Home Infusion Therapy Services 
for CYs 2019 and 2020
    In the CY 2019 HH PPS proposed rule (83 FR 32340) we discussed the 
implementation of the home infusion therapy services temporary 
transitional payment under paragraph (7) of section 1834(u) of the Act, 
as added by section 50401 of the BBA of 2018 (Pub. L. 115-123). This 
section provided for a temporary transitional payment for 
administration of home infusion drugs for 2019 and 2020. These services 
must be furnished by an eligible home infusion supplier in the 
individual's home to an individual who is under the care of an 
applicable provider 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. Section 1834(u)(7)(F) of the Act 
defines eligible home infusion suppliers as suppliers that are enrolled 
in Medicare as pharmacies that furnish external infusion pumps and 
external infusion pump supplies, and that maintain all pharmacy 
licensure requirements in the State in which the applicable infusion 
drugs are administered. This means that existing DME suppliers that are 
enrolled in Medicare as pharmacies that provide external infusion pumps 
and supplies are considered eligible home infusion suppliers. 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 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. Additionally, section 1834(u)(7)(C) of the 
Act specifies the HCPCS codes for the drugs and biologicals covered 
under the Local Coverage Determinations (LCDs) for External Infusion 
Pumps, and identifies three payment categories for which a single 
payment amount will be established for home infusion therapy services 
furnished on each infusion drug administration calendar day. Payment 
category 1 includes antifungals and antivirals, uninterrupted long-term 
infusions, pain management, inotropic, and chelation drugs. Payment 
category 2 includes subcutaneous immunotherapy infusions. Payment 
category 3 includes certain chemotherapy drugs. The payment category 
for subsequent transitional home infusion drug additions to the LCDs 
and compounded infusion drugs not otherwise classified, as identified 
by HCPCS codes J7799 and J7999, will be determined by the Medicare 
administrative contractors.
    As set out at new section 1834(u)(7)(D) of the Act, each payment 
category will be paid amounts equal to amounts for statutorily 
specified codes for which payment is made under the Physician Fee 
Schedule for each infusion drug administration calendar day in the 
individual's home for drugs assigned to such category. No geographic 
adjustment applies to the payments. In accordance with section 
1834(u)(7)(E)(ii) of the Act, 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 would be made.
    In the CY 2019 HH PPS proposed rule, we outlined the billing 
procedure for the temporary transitional payment. We created a new 
HCPCS G-code for each of the three payment categories. We stated that 
the eligible home infusion supplier will submit, in line-item detail on 
the claim, a G-code for each infusion drug administration

[[Page 56580]]

calendar day, which would include the length of time for which 
professional services were furnished (in 15 minute increments). These 
G-codes can be billed separately from or on the same claim as the DME, 
supplies, and infusion drug. However, under the temporary transitional 
payment period, the eligible home infusion supplier is required to be 
enrolled as a pharmacy that provides external infusion pumps and 
external infusion pump supplies and maintains all pharmacy licensure 
requirements. Therefore, during this period, it is likely that the G-
codes will be billed on the same claim as the equipment, supplies, and 
drug. However, for the full implementation of the benefit in 2021, 
there may be two different suppliers: One furnishing the home infusion 
therapy services in the home and one furnishing the DME, supplies, and 
drug. The claims for the temporary transitional payment will be 
processed through the DME MACs. In order to implement the requirements 
of section 1834(u)(7) of the Act for this temporary transitional 
payment, we will issue a Change Request (CR) prior to implementation of 
this temporary transitional payment, including the G-codes needed for 
billing, outlining the requirements for the claims processing changes 
needed to implement this payment.
    In general, section 1834(u)(7) specifies, in detail, the 
requirements of the temporary transitional payment for home infusion 
therapy services, and in most instances, we generally do not have the 
discretion to apply different policies. However, we proposed a 
regulatory definition of ``infusion drug administration calendar day'' 
to specify in more detail, the policy in the statute as to when 
Medicare should make a single payment for home infusion therapy 
services. As required by section 1834(u)(1)(A)(ii) of the Act, a unit 
of single payment under the home infusion therapy benefit payment 
system is for each infusion drug administration calendar day in the 
individual's home. Section 1834(u)(7)(E)(i) clarifies that 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)) were furnished to administer such drugs to 
such individual. Therefore, we proposed to define in regulation that 
``infusion drug administration calendar day'' refers to payment for 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. As we stated in the proposed rule, we believe this to 
mean skilled services as set out at 42 CFR. 409.32. This regulation 
states that the skilled services furnished on such day must be so 
inherently complex that they can only be safely and effectively 
furnished by, or under the supervision of, professional or technical 
personnel.
    The following is a summary of the public comments received on the 
``Proposed Temporary Transitional Payment for Home Infusion Therapy 
Services for CYs 2019 and 2020'' and our responses.
    Comment: Several commenters supported the proposed definition of 
``infusion drug administration calendar day'' and noted that the home 
infusion payment rates for 2019 and 2020 specified in the statute are 
generally comparable and, in some cases, higher than the payment rates 
for an in-home visit under the home health prospective payment system. 
MedPAC agreed with CMS' requirement that home infusion therapy 
providers report the length of home visits on their claims submissions, 
as it would allow the agency to consider this data as it establishes 
the payment rates for 2021, and could help to inform the agency's 
consideration of potential payment adjustments based on patient acuity 
or drug administration complexity.
    Response: We thank the commenters for their review and support of 
both the temporary and permanent payment structures for home infusion 
therapy services. We agree that the data obtained by requiring the 
length of the visit on the claim will be helpful in establishing 
payment adjustments for the full implementation of the benefit in 2021.
    Comment: In general, other commenters stated that the definition of 
``infusion drug administration calendar day'', and the resulting 
payment limitation based on physical presence would be contrary to law 
and Congressional intent, and would inappropriately limit the number of 
days of payment for home infusion therapy professional services. 
Commenters expressed concern that tying payment to days for which a 
nurse provides in-person professional services, would limit payment 
only to a small subset of the many professional services furnished in 
connection with home infusion. Commenters stated that CMS should define 
infusion drug administration calendar day to include a broader set of 
professional services such as drug preparation, including sterile 
compounding; clinical care planning; care coordination; and other 
professional services that most often occur outside of the patient's 
home and remove the physical requirement that a nurse be in the home 
for payment to occur. Commenters also disagreed with the reference to 
the definition of ``skilled services'' as set out at Sec.  409.32. 
Commenters stated that it seems inappropriate to define home infusion 
therapy professional services as skilled services in a skilled nursing 
facility (SNF).
    Response: We agree that there are a variety of providers and 
professional services involved in home infusion therapy and recognize 
their significance in ensuring that therapy is safe and effective in 
the home.
    However, in accordance with section 1861(iii)(1) of the Act, the 
term ``home infusion therapy'' means the items and services furnished 
by a qualified home infusion therapy supplier, which are furnished in 
the individual's home. Likewise, section 1834(u)(7)(B)(iv) establishes 
a single payment amount for each infusion drug administration calendar 
day in the individual's home. Additionally, section 1834(u)(7)(E)(i) of 
the Act states that payment to an eligible home infusion supplier or 
qualified home infusion therapy supplier for an infusion drug 
administration calendar day in the individual's home refers to payment 
only for the date on which professional services, as described in 
section 1861(iii)(2) of the Act, were furnished to administer such 
drugs to such individual. This includes all such drugs administered to 
such individual on such day. We believe the BBA of 2018 includes this 
clarification of ``infusion drug administration calendar day'' in order 
to establish clear parameters so as to explicitly pay for services that 
occur in the patient's home when the drug is being administered. Our 
interpretation of the phrase ``only for the date on which professional 
services, as described in section 1861(iii)(2) of the Act, were 
furnished'' is that mere infusion without any professional services 
furnished cannot trigger a home infusion therapy services payment for 
any day the drug is infused by the DME pump. Thus, we believe that the 
language in the statute clearly delineates a subset of days on which 
professional services are provided in the patient's home in order for 
payment to occur.
    Additionally, section 1834(u)(7)(A)(i) of the Act states that 
payment to an eligible home infusion supplier is for items and services 
furnished in coordination with the furnishing of transitional home 
infusion drugs. The language does not indicate that payment is for the 
furnishing of the home infusion drug, but for the services provided 
together and in cooperation

[[Page 56581]]

with the furnishing of the drug. The Medicare payment for the drug is 
made separately from home infusion therapy services. The statute also 
states that payment is for the professional services furnished ``to 
administer'' such drugs to such individual. As the term 
``administered'' refers only to the physical process by which the drug 
enters the patient's body,\81\ then the professional must be in the 
patient's home furnishing services specifically related to this 
process. We noted in the CY 2019 HH PPS proposed rule that we 
understand that there may be professional services furnished in the 
patient's home that do not occur on a day the drug is being 
administered (83 FR 32464). However, we note that the home infusion 
therapy services temporary transitional payment is a unit of single 
payment, meaning all home infusion therapy services furnished, which 
include professional services, training and education, remote 
monitoring and monitoring, are built into the payment for the day the 
professional services are furnished in the home and the drug is being 
administered. With the addition of the home infusion therapy services 
temporary transitional payment, suppliers will still receive payments 
for furnishing the equipment, the supplies, and the drug (technically 
considered a supply) under the DME benefit; but will also receive a 
separate payment when professional services are furnished in the 
patient's home under the home infusion therapy benefit.
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    \81\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
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    Furthermore, we note that the payment for an infusion drug 
administration calendar day is a single payment amount covering: 
professional services, including nursing services, furnished in 
accordance with a plan of care; training and education (not otherwise 
paid for as durable medical equipment); remote monitoring; and 
monitoring services furnished by a qualified home infusion therapy 
supplier. Therefore, at Sec.  486.525, we have mirrored the language in 
section 1861(iii)(2)(A) of the Act that requires the provision of 
professional services, including nursing services, furnished by the 
home infusion therapy supplier in accordance with the plan of care. 
Since the Medicare payment is a single payment amount, we do not 
believe it is necessary to define ``professional services'' in 
regulation. By specifically enumerating a specific list of services we 
would risk inadvertently excluding services that may be necessary for 
the care of a specific patient as part of the required services under 
the home infusion therapy benefit.
    Section 1861(iii)(1)(B) requires the individual to be under a plan 
of care, established by a physician, prescribing the type, amount, and 
duration of home infusion therapy services that are to be furnished. 
Thus, it is the individual's physician who is responsible for 
establishing the type and scope of professional services needed in the 
home in order to ensure home infusion therapy is successful. In the 
proposed rule, we did state that the services on this day must meet the 
criteria for skilled services as set out at Sec.  409.32. This criteria 
states that to be considered a skilled service, the service must be so 
inherently complex that it can be safely and effectively performed only 
by, or under the supervision of, professional or technical personnel. 
Although this is a requirement for coverage of post-hospital SNF care, 
the definition of skilled services is not specific to skilled nursing 
services in a SNF. Section 409.42(c)(1) under the home health benefit 
also references Sec.  409.32 as the criteria for intermittent skilled 
nursing services. Additionally, although both benefits require 
``skilled services'' in reference to nursing, the definition is not 
exclusive to nursing services.
    Finally, section 1834(u)(7)(D) of the Act sets the temporary 
transitional payment equal to 4 units at the amounts determined under 
the physician fee schedule (that is, equivalent to 4 hours of infusion 
in a physician's office). Payment for an infusion drug administered in 
a physician's office or outpatient center is made based on the 
occurrence of the professional services furnished during the visit. The 
professional services necessary for the infusion drug administration at 
these sites of care are factored into the payment for the visit, not 
separately payable. As such, it is not necessary to define the 
professional services required for infusion drug administration in a 
physician's office or outpatient center because payment is not 
dependent upon the individual services furnished, but rather the 
occurrence of the visit and the professional services furnished at the 
time. Likewise, the home infusion therapy services temporary 
transitional payment includes payment for any professional services 
furnished in the patient's home to administer the infusion drug.
    Comment: A commenter recommended CMS add additional payment for 
visits exceeding a median visit time period such as 2 or 3 hours, as 
initial visits in particular can vary from 1 to 6 hours. The commenter 
stated that in the absence of these additional payments, home infusion 
suppliers may limit the types of patients they accept during the 
transitional period.
    Response: Section 1834(u)(7)(D) of the Act sets the temporary 
transitional payment equal to 4 units at the amounts determined under 
the physician fee schedule (that is, equivalent to 4 hours of infusion 
in a physician's office). Although we do recognize that there may be 
some visits that exceed the number of units allowed, some visits may 
also be shorter. The temporary transitional payment is statutorily 
limited to the payment methodology as put forth in section 
1834(u)(7)(D) of the Act.
    Comment: Another commenter stated that many chronically ill 
patients depend on home health agencies for home infusion therapy 
services and supplies, and stated that home health agencies should 
continue to be paid as they currently are for home infusion. Another 
commenter stated that many home infusion suppliers do not actually 
provide the necessary skilled nursing support and must contract with 
home health agencies, which in turn, requires the home infusion company 
to assume responsibility for visits which may be unrelated to the 
patient's infusion therapy.
    Response: It is important to emphasize that the home infusion 
therapy services temporary transitional payment is separate from the 
home health benefit. Home infusion therapy is excluded from the 
Medicare home health benefit, and separately payable, beginning January 
1, 2019. Section 1842(u)(7)(F) of the Act requires eligible home 
infusion suppliers to be Medicare DME suppliers that are enrolled as 
pharmacies that supply external infusion pumps and supplies in order to 
receive the home infusion therapy services temporary transitional 
payment. Not until the full implementation of the benefit in 2021 will 
home health agencies have the option of becoming home infusion therapy 
suppliers.
    It is unclear why the commenter states that the home infusion 
supplier would be required to assume responsibility for visits which 
may be unrelated to the patient's infusion therapy. We recognize that 
currently home infusion suppliers may contract with HHAs to furnish the 
nursing services; however, it is incumbent upon the home infusion 
supplier to negotiate appropriate contract terms in order to only 
assume responsibility for services related to home infusion therapy.
    We also note that section VI.C.2.f. of the proposed rule discusses 
the

[[Page 56582]]

potential relationship/interaction between the home infusion therapy 
benefit and home health benefit. We stated that although the patient is 
not required to be homebound in order to receive home infusion therapy 
services, we anticipate that there may be circumstances when a patient 
may utilize both the home health benefit and the home infusion therapy 
benefit concurrently. We will provide further discussion on this 
relationship, including how we anticipate HHAs that furnish both home 
health and home infusion therapy services would submit claims for each 
of these services, in future rulemaking.
    Comment: A few commenters expressed support for the inclusion of 
requirements for remote monitoring in the home infusion benefit, and 
encouraged CMS to consider how to incorporate the use of telehealth 
into the final home infusion payment system. A commenter suggested that 
CMS include requirements that monitoring be performed using medical 
devices cleared by the FDA for remote monitoring purposes.
    Response: As we do not have specific policies surrounding the 
technology used in remote monitoring, for now we choose not to be 
prescriptive regarding how remote monitoring, or which remote 
monitoring devices, are used in home infusion. Anecdotally, we have 
heard from many home infusion providers that monitoring in home 
infusion consists mainly of phone calls. Likewise, the consensus from 
TEP members was that physical assessment and in-person monitoring is 
more common in home infusion due to the importance of visualizing the 
access site.
    Comment: Many commenters stated that the proposed definition of 
infusion drug administration calendar day assumes that a nurse would be 
present for each administration of the home infusion drug. Several 
comments stated that requiring a nurse to come for every infusion day 
was inefficient, unnecessary, and would put a tremendous financial 
burden on patients who could not afford to have a nurse come every day 
to administer the drug. Several commenters stated concern regarding the 
potential inability to receive their infusion drugs on those days in 
which a skilled professional is not present in the home during the 
administration of the infusion drug. Some commenters stated that this 
requirement would also cause an access issue for home infusion 
patients, possibly resulting in an increase in deaths among those who 
receive home infusion drugs, though no specific reason was provided as 
to why this would be the case. Another commenter stated that infusion 
suppliers would be forced to cut back on services, especially in rural 
areas, due to a limited supply of nurses. Additionally, this commenter 
stated that agencies will have to determine whether financially they 
are able to cover non-reimbursed costs associated with the benefit for 
Medicare patients, given that other payers do not require nurses to be 
present when drugs are infused in a patient's home.
    Response: We wish to remind stakeholders that the provision of home 
infusion is not contingent upon a nurse being present each and every 
day a drug is being infused, nor that a nurse is present during the 
entire administration of the drug. An important goal of home infusion 
therapy services is to teach patients to safely, effectively, and 
independently self-administer the drug in the home. The home infusion 
therapy services paid under this benefit furnished in the patient's 
home help ensure that patients and/or their caregivers can reach this 
goal. The requirement that a skilled professional be in the home on a 
day an infusion drug is administered is only for purposes of 
determining the days for which the bundled payment for home infusion 
therapy services is made. We also note that there is no limit on the 
number of times that a home infusion therapy services payment would be 
made if a nurse needed to visit the beneficiary's home more than once a 
week.
    The payment for professional services and training and education 
(not otherwise paid for under the Medicare Part B DME benefit), remote 
monitoring and monitoring services is only made when a skilled 
professional is physically present in a patient's home on a day of drug 
administration. This does not mean that that the external infusion 
pump, drug, and related supplies are not covered on days when there is 
not a skilled professional in the home. The home infusion therapy 
services temporary transitional payment is a separately paid amount 
from the external infusion pump, drug, and related supplies.
    Additionally, we state in the proposed rule that the professional 
services covered under this benefit are not intended to provide on-
going nursing supervision throughout each infusion. We do not expect a 
nurse to be present for every infusion, or to stay for the duration of 
each infusion once the patient and/or caregiver has been taught to 
operate the pump. In section VI.C.2.d. of the proposed rule, we outline 
the training and education services that we believe the home infusion 
therapy payment would cover. We state that these would include a 
limited amount of teaching and training on the provision of home 
infusion drugs that is not already covered under the DME benefit.
    Furthermore, section 1861(iii)(2)(B) includes the provision of 
monitoring and remote monitoring as part of the home infusion therapy 
benefit. In the proposed rule, we indicated that we understand that 
some home infusion therapy patients may require daily monitoring, but 
generally do not need to be seen by a practitioner daily. In section 
VI.C.2.d. of the proposed rule, we state our belief that monitoring and 
remote monitoring can enable daily contact with, or assessment of 
certain patients without necessitating a visit.
    Considering that we do not expect a visit to be made for each 
infusion drug administration, we also do not believe the supplier 
should be paid every day that the medication is infused regardless of 
whether or not direct care services are furnished. We should also 
emphasize that the patient is responsible for 20 percent coinsurance 
for every home infusion therapy services payment in addition to the 20 
percent coinsurance charged for the DME infusion pump supplies and the 
drug. Therefore, we believe tying the payment to a visit in the 
beneficiary's home would ensure that the beneficiary is receiving 
direct care services for which he/she is paying 20 percent coinsurance. 
We state in the proposed rule that we generally anticipate that a home 
infusion therapy supplier would provide a visit approximately two times 
a week for the first week and then weekly thereafter over the course of 
infusion therapy depending on the drug and patient. Therefore, the 
proposed definition of infusion drug administration calendar day would 
result in payment only for these days when a visit occurs. Likewise, 
the beneficiary would be responsible for the 20 percent coinsurance 
amount only on these days. Section 1834(u)(7) requires that the 
temporary transitional home infusion therapy services payment be equal 
to 4 units at the amounts determined under the physician fee schedule 
(that is, the equivalent of 4 hours of infusion in a physician's 
office). This amount would range from $141 to $240 (using CY 2018 fee 
schedule amounts). If payment were to be made every day an infusion 
occurred, regardless of whether a visit was made, the beneficiary would 
be responsible for the home infusion therapy services coinsurance 
amount each and every day the infusion

[[Page 56583]]

occurred. For some patients on daily, continuous infusions, this would 
mean paying a 20 percent coinsurance amount every day (approximately 
$900 per month in cost-sharing and more than $10,000 annually). In 
accordance with CMS' proposed definition of infusion drug 
administration calendar day, the infusion therapy supplier would be 
paid every time a visit is made and a skilled service was furnished in 
the individual's home, which we anticipate would be at least weekly. 
Furthermore, we believe requiring that direct patient care services be 
made in order to receive payment promotes visits that provide direct 
care to the patient, which may help to mitigate any infusion related 
reactions or unplanned readmissions or ED visits. Similar to the 
physician office and the hospital outpatient setting, Medicare payment 
is made for direct care services furnished to a patient for infusion 
drug administration. We believe that, clinically, it is occasionally 
necessary for a nurse to visualize part of the administration of the 
infusion drug as this is part of his/her overall patient assessment 
while in the home. For instance, a nurse may observe dyspnea, 
tachycardia, or infiltration during an infusion and can appropriately 
intervene to ensure the safe and effective administration of the 
infusion.
    We also do not anticipate that this requirement would lead to any 
additional home visits than are currently provided by home infusion 
suppliers. As many commenters pointed out, visits are often provided 
weekly, which aligns with what we stated in the proposed rule. 
Furthermore, we consider this benefit to be an additional payment for 
the direct care services associated in coordination with the furnishing 
of home infusion drugs.
    Comment: Some commenters expressed concern regarding availability 
and categorization of specific infusions such as Total Parenteral 
Nutrition (TPN), intravenous hydration, or antiemetic drugs.
    Response: While ``home infusion drug'' is defined under section 
1861(iii)(3)(C) as a 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, 
section 1834(u)(7)(A)(iii) of the Act includes an exception to the 
definition of home infusion drug if the drug is identified under 
section 1834(u)(7)(C) of the Act. This provision for the temporary 
transitional payment specifies the HCPCS codes for the drugs and 
biologicals covered under the Local Coverage Determinations (LCD) for 
External Infusion Pumps. Therefore, only these drugs are covered under 
the home infusion therapy services temporary transitional payment. We 
intend to examine the criteria for home infusion drugs for coverage of 
home infusion therapy services, for implementation of the full home 
infusion therapy benefit in 2021.
    Comment: A few commenters pointed out a technical edit regarding 
billing related to the creation of the G-codes and questioned whether 
our intent is to create three new G-codes for each of the three payment 
categories or one new G-code for each of the categories.
    Response: We thank the commenters for bringing this to our 
attention. To clarify, we plan on creating one new G-code for each of 
the three payment categories.
    Final Decision: We are finalizing the definition of infusion drug 
administration calendar day for the home infusion therapy services 
temporary transitional payment to mean payment is for 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. We recognize the 
concerns from stakeholders and members of Congress on our 
interpretation of ``infusion drug administration calendar day'', 
including with respect to professional services that may be provided 
outside of the home and, as applicable, payment amounts for such 
services. It is our intention to ensure access to home infusion therapy 
services in accordance with section 50401 of the BBA of 2018. 
Therefore, we believe the best course of action is to monitor the 
effects on access to care of finalizing this definition and, if 
warranted and within the limits of our statutory authority, engage in 
additional rulemaking or guidance regarding this definition for 
temporary transitional payments. We seek comments on this 
interpretation and on its potential effects on access to care.''
1. Solicitation of Public Comments Regarding Payment for Home Infusion 
Therapy Services for CY 2021 and Subsequent Years
    Upon the expiration of the home infusion therapy services temporary 
transitional payment, we will be fully implementing the home infusion 
therapy services payment system under section 1834(u)(1) of the Act, as 
added by section 5012 of the 21st Century Cures Act (Pub. L. 114-255). 
In the CY 2019 HH PPS proposed rule (83 FR 32340), we discussed the 
provisions of the law, and in anticipation of future rulemaking, 
solicited comments regarding the payment system for home infusion 
therapy services beginning in CY 2021. We discussed the relationship 
between the new home infusion therapy benefit and the existing Medicare 
DME and home health benefits; the definition of infusion drug 
administration day; payment basis, limitation on payment, required and 
discretionary adjustments, and billing procedures; the professional/
nursing services and monitoring related to the administration of home 
infusion drugs; and the role of prior authorization. Specifically, we 
requested comments on retaining the definition of ``infusion drug 
administration calendar day'', as proposed in section IV.C.2. of the 
proposed rule for the full implementation of the home infusion therapy 
services benefit, and invited comments on any additional 
interpretations of professional, nursing, training and education, and 
monitoring services that may be considered under the scope of the home 
infusion therapy benefit. We solicited comments on ways to account for 
therapy type and complexity of administration, as well as ways to 
capture patient acuity, and requested feedback on situations that may 
incur an outlier payment and potential designs for an outlier payment 
calculation. And finally, we invited comments on the unit of single 
payment; limitations on payment; prior authorization; and required and 
discretionary adjustments, and solicited any additional suggestions as 
to how qualified home infusion therapy suppliers should bill and be 
paid for services under the home infusion therapy benefit, including 
whether it is reasonable to require two separate claims submissions to 
account for different components of home infusion therapy.
    As there is overlap between the provisions of the home infusion 
therapy services temporary transitional payment and the full home 
infusion therapy benefit to be implemented in 2021, many of the 
proposed rule comments we received pertained to both. However, while we 
did not include proposals regarding payment for home infusion therapy 
services for CY 2021 and beyond, we did receive several comments 
related specifically to implementation of the full benefit. These 
comments included suggestions regarding billing, payment basis and 
adjustments, prior authorization, and

[[Page 56584]]

the relationship between the home infusion and home health benefits. We 
appreciate commenters' review of, and input regarding the discussion of 
the home infusion benefit, and will give careful consideration to all 
comments received when implementing the permanent Medicare payment 
structure for home infusion therapy services.
    We did receive several technical comments regarding certain 
provisions that are addressed in the responses in this section of this 
final rule with comment period.
    Comment: Several commenters expressed concern with retaining the 
proposed definition of ``infusion drug administration calendar day'' 
for the full implementation of the home infusion therapy benefit in 
2021 as required by the 21st Century Cures Act.
    Response: While we did not formally propose a definition of 
``infusion drug administration calendar day'' in the discussion of the 
full implementation of the home infusion therapy benefit in 2021, we 
will note that the clarification in section 1834(u)(7)(E)(i) of the 
Act, as added by the BBA of 2018, regarding ``infusion drug 
administration calendar day'' provides that this definition is with 
respect to the furnishing of ``transitional home infusion drugs'' or 
``home infusion drugs'' to an individual by an ``eligible home infusion 
supplier'' or a ``qualified home infusion therapy supplier.'' As ``home 
infusion drugs'' and ``qualified home infusion therapy supplier'' are 
terms for the permanent benefit in the 21st Century Cures Act, this 
definition of ``infusion drug administration calendar day'' would 
pertain to both the temporary benefit and the full benefit.
    Comment: A few commenters expressed concern with the potential 
exclusion of particular drugs from the full implementation of the home 
infusion therapy services benefit. Another commenter stated the 
understanding that Intravenous Immune Globulin (IVIG) is covered under 
the legislation enacted by the 21st Century Cures Act. Additionally, 
this commenter expressed concern with the conclusion of the Medicare 
IVIG demonstration as it relates to the full implementation of the home 
infusion therapy benefit and encouraged CMS to expedite the final 
report prior to the implementation of the benefit. Another commenter 
expressed concern that, because the legislation excludes drugs and 
biologicals on a self-administered drug (SAD) exclusion list, some 
subcutaneous immune globulins (SCIG) that are covered under the 
temporary transitional payment would be excluded from the benefit in 
2021.
    Response: We appreciate the commenter's concern regarding the 
conclusion of the IVIG demonstration; however, the timeline of the 
demonstration's final report is out of the scope of this rule. While 
section 50401 of the BBA of 2018 defines ``transitional home infusion 
drug'' by identifying the HCPCS codes for drugs under the LCD that are 
for coverage under the home infusion therapy services temporary 
transitional payment, the full implementation of the benefit in 2021 is 
less specific with regard to particular home infusion drugs. 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 durable 
medical equipment. Such term does not include insulin pump systems or 
self-administered drugs or biologicals on a self-administered drug 
exclusion list. We understand commenter concern regarding certain drugs 
and biologicals, specifically SCIG and IVIG, and will continue to 
examine the scope of drugs covered under Part B, along with the 
criteria for inclusion on the Self-Administered Drug Exclusion list for 
full implementation of the home infusion therapy benefit in 2021.
    Comment: A commenter urged CMS to ensure that coverage guidelines 
for home infusion therapy make continued coverage available even if the 
beneficiary and/or family member is unwilling or unable to be trained 
to assume responsibility for the infusion themselves.
    Response: We should reiterate that the home infusion therapy 
benefit is intended for drugs that are administered through an item of 
DME. As DME must be appropriate for use in the home, DMEPOS supplier 
standards require suppliers to document that they or another qualified 
party provided beneficiaries with instructions and education on safe 
and effective operation of the equipment (42 CFR 424.57(c)(12)). CMS 
convened a technical expert panel (TEP) in August of 2018, during which 
TEP members concurred that despite a physician's belief that home 
infusion may be medically acceptable and appropriate for a patient, 
success is very individualized and to a great extent, patient-
dependent. We solicited comments regarding a reasonable number of 
visits needed to train the patient and caregiver on safe and effective 
use of the pump, and many commenters supported our assumption of two 
visits the first week and then weekly thereafter. We also acknowledged 
that there may be patients that are unable or unwilling to self-
administer, in which case the home would not be the appropriate site of 
care.
    We appreciate commenter feedback and will take all comments under 
consideration while implementing the permanent home infusion therapy 
services benefit. We encourage commenters to submit additional comments 
regarding the full implementation of the benefit to the home infusion 
policy mailbox at [email protected].

VII. Changes to the Accreditation Requirements for Certain Medicare-
Certified Providers and Suppliers

A. Background

    To participate in the Medicare program, Medicare-certified 
providers and suppliers of health care services, must be substantially 
in compliance with specified statutory requirements of the Act, as well 
as any additional regulatory requirements related to the health and 
safety of patients specified by the Secretary of the Department of 
Health and Human Services (HHS). Medicare certified providers and 
suppliers are enrolled in the Medicare program by entering into an 
agreement with Medicare. They include hospitals, skilled nursing 
facilities, home health agencies, hospice programs, rural health 
clinics, critical access hospitals, comprehensive outpatient 
rehabilitation facilities, laboratories, clinics, rehabilitation 
agencies, public health agencies, and ambulatory surgical centers. 
These health and safety requirements are generally called conditions of 
participation (CoPs) for most providers, requirements for skilled 
nursing facilities (SNFs), conditions for coverage (CfCs) for 
ambulatory surgical centers (ASCs) and other suppliers, and conditions 
for certification for rural health clinics (RHCs). A Medicare-certified 
provider or supplier that does not substantially comply with the 
applicable health and safety requirements risks having its 
participation in the Medicare program terminated.
    In accordance with section 1864 of the Act, state health 
departments or similar agencies, under an agreement with CMS, survey 
health care providers and suppliers to ascertain compliance with the 
applicable CoPs, CfCs, conditions of certification, or requirements, 
and certify their findings to us. Based on these State Survey Agency 
(SA) certifications, we determine whether the provider or

[[Page 56585]]

supplier qualifies, or continues to qualify, for participation in the 
Medicare program.
    Section 1865(a) of the Act allows most health care facilities to 
demonstrate compliance with Medicare CoPs, requirements, CfCs, or 
conditions for certification through accreditation by a CMS-approved 
program of a national accreditation body. If an AO is recognized by the 
Secretary as having standards for accreditation that meet or exceed 
Medicare requirements, any provider or supplier accredited by the AO's 
CMS-approved accreditation program may be deemed by us to meet the 
Medicare conditions or requirements.
    We are responsible for the review, approval and subsequent 
oversight of national AOs' Medicare accreditation programs, and for 
ensuring providers or suppliers accredited by the AO meet the quality 
and patient safety standards required by the Medicare CoPs, 
requirements, CfCs, and conditions for certification. Any national AO 
seeking approval of an accreditation program in accordance with section 
1865(a) of the Act must apply for and be approved by CMS for a period 
not to exceed 6 years.
    The AO must reapply for renewed CMS approval of an accreditation 
program before the date its approval period expires. This allows 
providers or suppliers accredited under the program to continue to be 
deemed to be in compliance with the applicable Medicare CoPs, 
requirements, CfCs, and conditions for certification. Regulations 
implementing these provisions are found at 42 CFR 488.1 through 488.9.
    We believe that it is necessary to revise the regulations for 
Medicare-certified providers and providers to add two new requirements 
for the AOs that accredit certified providers and providers. First, we 
proposed at Sec.  488.5 to require AOs for Medicare-certified providers 
and suppliers to include a written statement in their application which 
states that if a fully accredited and deemed facility in good standing 
provides written notification that they wish to voluntarily withdraw 
from the AO's CMS-approved accreditation program, the AO must continue 
the facility's current accreditation until the effective date of 
withdrawal identified by the facility or the expiration date of the 
term of accreditation, whichever comes first. We also proposed to 
modify the AO oversight regulations at Sec.  488.5 by adding new 
requirements for training for AO surveyors.

B. Changes to Certain Requirements for Medicare-Certified Providers and 
Suppliers at Part 488

1. Continuation of Term of Accreditation When a Medicare-Certified 
Provider or Supplier Decides to Voluntarily Terminate the Services of 
an Accrediting Organization (Sec.  488.5)
    We proposed adding a new provision to the approval and oversight 
regulations for AOs that accredit Medicare certified providers and 
suppliers at Sec.  488.5(a)(17)(iii), which would require that, with an 
initial or renewal application for CMS-approval of a Medicare certified 
provider or supplier accreditation program, an AO must include a 
written statement agreeing that when a fully accredited, deemed 
provider or supplier in good standing notifies its AO that it wishes to 
voluntarily withdraw from the AO's accreditation program, the AO would 
honor the provider's or supplier's current term of accreditation until 
the effective date of withdrawal identified by the facility, or the 
expiration date of the term of accreditation, whichever comes first. We 
made this proposal because we have received numerous complaints from 
accredited and deemed facilities in good standing with their then-
current AO stating that once they provide notification to the AO of 
their intent to voluntarily withdrawal their accreditation business 
from that AO, the AO frequently terminated their accreditation 
immediately, without regard to their current accreditation status, up 
to date payment of fees, contract status, or the facility's requested 
effective date of withdrawal. We do not believe it is reasonable for 
AOs to penalize facilities because they choose to terminate the 
services of an AO.
    Providers and suppliers may be left without an accreditation status 
that would allow them to continue to participate in Medicare.
    Comment: Several commenters expressed general support for our 
proposal at Sec.  488.5(a)(17)(iii), which would require that, with an 
initial or renewal application for CMS-approval of a Medicare certified 
provider or supplier accreditation program, AO must include a written 
statement agreeing that when a fully accredited, deemed provider or 
supplier in good standing notifies its AO that it wishes to voluntarily 
withdraw from the AO's accreditation program, the AO would honor the 
provider's or supplier's current term of accreditation until the 
effective date of withdrawal identified by the facility, or the 
expiration date of the term of accreditation, whichever comes first. A 
commenter stated that ``we agree with this proposed change because when 
a provider/supplier is accredited in good standing their accreditation 
should be good for the full term of their agreement with the 
accreditor.'' Another commenter stated the opinion that ``we agree that 
it is unreasonable for AOs to penalize facilities who choose to 
terminate the services of that AO, and as such, support this proposal. 
Another commenter stated full agreement with this proposal and stated 
that this is the standard operating procedure for this commenter's AO.
    Response: We thank these commenters for their input.
    Comment: Another commenter expressed agreement with the proposal 
regarding Sec.  488.5(a)(17)(iii) and in addition, expressed the 
opinion CMS should require all AOs for Medicare certified providers and 
suppliers to document the dates of accreditation as the dates of the 
actual survey and acceptance of the plan of correction. This commenter 
argued that the requirement was necessary because AOs that accredit 
large multiple site providers/suppliers use a corporate accreditation 
cycle where the dates of the accreditation cycle are the same for all 
sites.
    Response: We thank this commenter for their support for our 
proposal. We further that this commenter for the suggestion that CMS 
should consider a policy applicable to AOs that accredit large multiple 
site providers/suppliers which utilize a corporate accreditation cycle 
where the dates of the accreditation cycle are the same for all sites. 
However, this is an issue that is outside the scope of the proposed 
rule. We will take this information under advisement. We thank this 
commenter for bringing this concern to our attention.
    Comment: A commenter expressed disapproval of our proposal, stating 
the proposal, as written, undermines the autonomy of this and all other 
AOs to enforce their own policies. The commenter also stated that each 
AO develops its own policies and procedures related to accreditation 
termination effective dates, which CMS subsequently approves.
    The commenter also stated that this proposal would allow facilities 
to circumvent the mechanisms AOs for Medicare certified providers and 
suppliers have had in place for ongoing review of accredited 
facilities. The commenter believes that the rule, as written, would 
require this AO to maintain a facility's accreditation status 
regardless of the commenter AO's

[[Page 56586]]

policies and procedures related to termination of a facility's 
accreditation status. The commenter noted that throughout the 
accreditation process, participating facilities are obligated to comply 
with an AO's standards, policies, and procedures until an awarded 
accreditation term expires or terminates; therefore, this proposal 
would conflict with an AO's operation of its accreditation program and 
its authority to make accreditation decisions. The commenter strongly 
urged CMS to withdraw this requirement.
    Response: We respectfully disagree with the views expressed by this 
commenter. We do not agree that the requirement would undermine the 
autonomy of this AO to enforce its own policies or conflict with 
commenter's AOs operation of its accreditation program and its 
authority to make accreditation decisions. This commenter provided no 
examples or explanation for how the addition of the proposed policy 
would do so.
    It is our position that if an accredited provider or supplier has 
paid the agreed upon accreditation fees, successfully gone through the 
survey process, and is in good standing with their AO, but has, for 
whatever reason, decided to switch accreditation to another AO or to 
submit to a survey by a state agency, there is no justifiable reason 
for the current AO to cancel that provider/suppliers accreditation 
prior to the expiration date.
    CMS has seen cases in which shortly after an AOs has been informed 
by one of its accredited providers/suppliers in good standing that said 
provide/supplier wishes to withdraw their accreditation business from 
that AO and become accredited by another AO (or obtain state 
certification), the current AO terminates that provider/suppliers 
accreditation, regardless of how much time remains on that provider's 
or supplier's existing term of accreditation. We believe that these 
instances of early termination of the accreditation of a provider/
suppliers in good standing, with no performance or complaint issues who 
has recently informed their AO that they were switching to another AO 
are either retaliatory in nature, or done because these providers were 
no longer considered a viable source of revenue. We agree that it is 
unreasonable for AOs to penalize facilities who choose to terminate the 
services of that AO, and as such, support this proposal.
    Final Decision: In consideration of the comments received, this 
provision will be added to 42 CFR 488.5(a)(17)(iii) as drafted, without 
modification.
2. Training Requirements for Accrediting Organization Surveyors (Sec.  
488.5(a)(7))
    We proposed to add a new requirement at Sec.  488.5(a)(7) which 
imposes a new training requirement for surveyors of AO that accredit 
Medicare-certified provider and supplier types by amending the 
provision at Sec.  488.5(a)(7). We proposed that all AO surveyors be 
required to complete the relevant program-specific CMS online trainings 
initially, and thereafter, consistent with requirements established by 
CMS for state surveyors. CMS provides a wide variety of comprehensive 
trainings through an on-demand integrated surveyor training website. 
These online trainings are available and can be accessed by state and 
federal surveyors and the public, free of charge, 24 hours a day, 365 
days a year. These online trainings are currently publically available 
for the SA surveyors.
    As part of our oversight of the AOs performance, CMS has contracted 
with the SAs to perform validation surveys on a sample of providers and 
suppliers (such as hospitals, critical access hospital, ambulatory 
surgical centers, and home health agencies) accredited by the AOs that 
accredit Medicare certified providers and suppliers. Validation surveys 
must be performed by the SA within 60 days of the survey performed by 
the AO. As a validation survey is performed within 60 days of the AO 
survey, we believe that the conditions at the hospital or other 
facility being surveyed will be similar at the time of the validation 
survey.
    The purpose of a validation survey is to compare the survey 
findings of the AO to the survey findings of the SA to see if there are 
any disparities. The amount of disparities found in the AO's survey is 
called the ``disparity rate'' and is tracked by CMS as an indication of 
the quality of the surveys performed by the AO.
    CMS has determined that many of the AOs' disparity rates have been 
consistently high. This means that the AOs have consistently failed to 
find the same condition level deficiencies in the care provided by the 
hospital or other providers surveyed that were found by the SA during 
the validation survey.
    At the time of the writing of the proposed rule, we believed that 
the disparity in findings made by the AO surveyors and those of the SA 
surveyors could largely be attributed the difference in the training 
and education provided to the AO surveyors. Each AO is responsible for 
providing training and education to their surveyors. In the proposed 
rule, we stated that because each AO is an independent entity, the 
surveyor training and education provided by each AO to its surveyor's 
varies and is not consistent. We further stated that CMS provides 
comprehensive online training to the SA surveyor staff on the CMS 
Surveyor Training website \82\ which are specific to each type of 
provider of supplier type to be surveyed.
---------------------------------------------------------------------------

    \82\ https://surveyortraining.cms.hhs.gov/.
---------------------------------------------------------------------------

    In the proposed rule, we stated that it was our belief that the 
AO's disparity rate would be decreased if all surveyors took the same 
training. We further stated the belief that completion of the same 
surveyor training by both SA and AO surveyors would increase the 
consistency between the results of the surveys performed by the SAs and 
AOs and have a positive impact on the historically high disparity rate. 
Therefore, we proposed that all AO surveyors be required to take the 
CMS online surveyor training offered on the CMS website. We further 
proposed to require each AO to provide CMS with documentation which 
provides proof that each surveyors had completed the CMS online 
surveyor training. Finally, we proposed that if the AO fails to provide 
this documentation, CMS could place the AO on an accreditation program 
review pursuant to Sec.  488.8(c). We received a number of comments in 
response to this proposals.
    Comment: Several commenters stated strong support CMS' proposal to 
require consistent, comprehensive training for AO surveyors.
    Response: We thank these commenters for their support of our 
proposal.
    Comment: Another commenter who supported CMS' proposal to require 
consistent, comprehensive training for AO surveyors stated that they 
did not believe the proposal went far enough. This commenter 
recommended that CMS undertake a rigorous review of the entire ``deemed 
status'' system. This commenter further stated concern that since these 
deemed-status health care providers are not subject to routine state 
certification surveys, they are not subject to the civil monetary 
penalties that could result from surveys conducted by state agencies. 
This commenter urged CMS to fix the flaws and loopholes in the deemed 
status program.
    Response: We thank this commenter for their support of the proposal 
to require AO surveyors to take the CMS online surveyor training. We 
further thank this commenter for the remainder of their suggestions. As 
these suggestions are outside the scope of the

[[Page 56587]]

topics discussed in the proposed rule they will not be discussed here. 
However, we will take this commenters suggestions under advisement.
    Comment: Several commenters urged CMS to consider including a 
corresponding decrease in CMS validation surveys for those AOs whose 
surveyors have completed the training, since the CMS online surveyor 
training which is supposed to decrease the disparity rate. Another 
commenter suggested that CMS resources devoted to validation surveys 
could be reduced, saving taxpayer dollars and lessening HHA time and 
effort spend on largely redundant surveys.
    In support of the request to decrease the number of validation 
surveys to be performed if this requirement for surveyor training is 
finalized, a commenter pointed out that there are other administrative 
reviews including the RAC, Pre Claim Review, Probe & Educate, and 
routine MAC ADR probes that could assess an AOs compliance and 
performance. Another commenter stated that while there are ample 
enforcement tools, CMS has not clearly targeted these efforts to bad 
actors and high-value HHAs have had to divert resources from direct 
care to administrative functions. This commenter suggestion that audit 
frequency should be determined using current data along with Program 
for Evaluating Payment Patterns Electronic Report (PEPPER) reports to 
identify underperforming and/or noncompliant agencies and that audits 
should be limited to topics within statutory and regulatory parameters.
    Response: CMS is currently in the process of reviewing and 
redesigning the validation process in an effort to make it more 
accurate, effective and less burdensome for facilities. While outside 
the scope of the proposals made, we will take the suggestions made by 
these commenters under advisement.
    Comment: In this section of this final rule with comment period is 
a summary of the remainder of the comments received in response to our 
response to our proposal to require surveyors for the AOs that accredit 
Medicare certified providers and suppliers to the take CMS online 
surveyor training:
     A commenter recommended that CMS make the online surveyor 
trainings available but not mandatory for all AO surveyor so that each 
AO could then evaluate its own training and education materials and 
make an independent decision regarding how best to use the CMS training 
tools.
     A commenter stated that they support the CMS aim of 
reducing disparity rates, but that they cannot support the proposal as 
written due to its vagueness.
     Another commenter stated that the proposed rule offers 
little guidance on CMS implementation of this new requirement. Another 
commenter expressed concern regarding how this requirement would be 
fully operationalized.
     A commenter noted that the proposed rule does not specify 
the CMS online training courses for which it expects completion. 
Another commenter expressed the concern that it is unclear from the 
text of this rule, how often surveyors would be required to participate 
in the training.
     Several commenters stated the belief that there are 
ambiguities in the proposal that essentially create further opportunity 
for non-uniformity in surveyor training across the industry. Any non-
uniformity in training could reduce the meaningfulness of any presumed 
links between surveyor training mandates and disparity rates that CMS 
hopes to identify and impact.
     Another commenter requested more clarity concerning 
training requirements including course enrollment expectations, 
frequency of course completion, and clarification regarding whether CMS 
intends to implement a reporting mechanism for AOs to validate surveyor 
course completion. This commenter expressed concern that, while the 
proposed rule proposed completion of ``relevant program specific CMS 
online trainings established for state surveyor,'' the variety of 
online training programs offered and the lack of specificity over the 
precise training modules required per program could create confusion 
over which precise training elements would be required for full rule 
compliance.
     Another commenter expressed doubt that a mandatory 
requirement for AO surveyors to take CMS online surveyor training would 
improve AO the disparity rates, and that reviewing online training does 
not guarantee surveyors will retain and then apply all the information 
from the trainings during their surveys.
     Several commenters strongly suggested that CMS needs to 
establish a measurable correlation between the proposal and the 
expected outcome before CMS proposes to require AOs to implement any 
costly program.
     Several commenters suggested that if CMS has questions and 
concerns with the current surveyor education provided by AOs, it seems 
like this would be an issue to be addressed when reevaluating that AO's 
own accreditation from CMS.
     A commenter also made the suggestion that CMS should also 
evaluate the length of surveys and determine whether it would make 
sense to have a minimum (or standard) length for all individuals 
surveying for a specific provider or supplier type. Or have a minimum 
(or standard) number of surveyors participating in each survey. This 
commenter stated the belief that there could be a number of factors 
involved in the disparity rate.
     Several commenters stated that they do not agree with CMS' 
assumptions that inconsistent training between SA surveyors and AO 
surveyors is the reason for high disparity rates. One of these 
commenters stated that they fail to see the correlation between 
different AO surveyor training programs and disparity rates when the 
disparity rate is a comparison of an SA survey result against an AO 
survey result and not a comparison between AOs.
     Another commenter recognizes that disparity rates are a 
constant challenge for CMS and AOs, and that root-cause factors driving 
high disparity rates are complex and multi-faceted. Yet another of 
these commenters stated that while surveyor training may be a factor 
that influences disparity rates, it is unclear whether mandating that 
AOs to require that surveyors complete CMS training modules will 
actually reduce the disparity rate. The hypothesis that mandating 
additional AO surveyor training will lower disparity rates is untested 
and unproven, and the basis for the hypothesis is unclear.
     Several commenters expressed the belief that unknown or 
alternative factors may truly drive high disparity rates and that there 
are multiple explanations as to why the disparity rate could be 
elevated that are not related to surveyor training. For example, 
according to these commenters, it is possible that there could be 
variance or issues with the validation surveyors. Reviewing online 
training does not guarantee surveyors will retain and then apply all 
the information from the trainings during their surveys.
     A number of commenters raised the following points in 
objection to our proposal that AO surveys complete CMS-provided 
mandatory surveyor training:
    ++ CMS reviews and approves all AO training, verifying its 
adequacy.
    ++ State agency surveyors are not required to have actual 
experience in the health care field for which they survey. This 
commenter stated that at least one accreditor requires a minimum of 5 
years' experience in the same field that they will survey, thus making 
them a subject matter expert.
    ++ State agencies send multiple surveyors for multiple days, where 
AOs

[[Page 56588]]

usually send one surveyor for 2 to 5 days. The length of the survey 
depends on the number of unduplicated admissions the facility bills 
over a 12 month period.
    ++ State agencies cite the same deficiencies multiple times. AOs 
normally do not.
    ++ There is not an appeal process for the AO in regard to a 
validation survey. When a validation survey comes back with 
deficiencies that the AO did not cite and does not agree with, CMS only 
accepts the state validation surveyors' deficiencies as accurate.
     Several commenters expressed concern that this new 
requirement would place significant new burden on AOs.
    A commenter recommended that CMS delay implementation of the 
current proposal, and instead bring together accreditation 
organizations and providers and suppliers to more fully explore how to 
improve disparity rates between AO and validation surveys. Several 
other commenters encouraged CMS to engage the AOs directly in both the 
initiative to reduce disparity rates and on any initiatives that may 
impact AO accreditation program operations.
    General Response: We agree with these commenters that the text of 
this section of the proposed rule may have been unclear about how the 
requirement for online surveyor training was to be operationalized and 
that it was not clear about the number and types of training the AO 
surveyor would have to take. While we do believe that the disparity 
rate would be decreased somewhat by the requirement that AO surveyors 
take the CMS online surveyor training, at this time CMS is not able to 
demonstrate that such training will significantly reduce the validation 
disparity rate. After consideration of the comments received, we 
acknowledge that root-cause factors driving high disparity rates are 
complex and multi-faceted and that there are a number of other factors 
that could have an impact on the disparity. We also acknowledge that 
while surveyor training may be a factor that influences disparity 
rates, it is unclear whether requiring that AOs require that surveyors 
complete CMS training modules will reduce the disparity rate. 
Therefore, after consideration of the comments received, we have 
decided not to finalize our proposal to require the surveyors for AOs 
that accredit Medicare certified providers and suppliers to take the 
CMS online surveyor training. However, it is important to note that 
many of the AOs' disparity rates have been consistently high. We are 
continuing to monitor these rates and look for ways to reduce them.
    Final Decision: After consideration of the comments received, we 
have decided not to finalize our proposal to require the surveyors for 
AOs that accredit Medicare certified providers and suppliers to take 
the CMS online surveyor training.

VIII. Requests for Information

    This section addressed two requests for information (RFI).

A. Request for Information on Promoting Interoperability and Electronic 
Healthcare Information Exchange Through Possible Revisions to the CMS 
Patient Health and Safety Requirements for Hospitals and Other 
Medicare- and Medicaid-Participating Providers and Suppliers

    In the CY 2019 HH PPS proposed rule (83 FR 32471 through 32473), we 
included a Request for Information (RFI) related to promoting 
interoperability and electronic health care information exchange. We 
received approximately 28 timely pieces of correspondence on this RFI. 
We appreciate the input provided by commenters.

B. Request for Information on Price Transparency: Improving Beneficiary 
Access to Home Health Agency Charge Information

    In the CY 2019 HH PPS proposed rule (83 FR 32473 and 32474), we 
included a Request for Information (RFI) related to price transparency 
and improving beneficiary access to home health agency charge 
information. We received approximately 15 timely pieces of 
correspondence on this RFI. We appreciate the input provided by 
commenters.

IX. 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.

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2017 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, the following Table 42 presents the mean 
hourly wage rate, fringe benefits costs and overhead (calculated at 100 
percent of salary), and the adjusted hourly wage.

[[Page 56589]]

[GRAPHIC] [TIFF OMITTED] TR13NO18.076

    This final rule with comment period makes reference to associated 
information collections that are not discussed in the regulation text 
contained in this document. These final changes are associated with the 
information collection request (ICR)--Outcome and Assessment 
Information Set (OASIS) OASIS-C2/ICD-10 (CMS-10545), approved under OMB 
control number 0938-1279. We note that on March 12, 2018 (83 FR 10730) 
we published a notice in the Federal Register seeking public comment on 
a revision to CMS-10545 (OMB control number 0938-1279), which will 
modify the OASIS and refer to the revised item set as the OASIS-D upon 
implementation of the revised data set on January 1, 2019 . We 
solicited public comment on additional changes related to when certain 
OASIS items are required to be completed by HHA clinicians due to the 
implementation of the patient-driven groupings model (PDGM) for CY 
2020, as outlined in section III.F of this final rule with comment 
period; and the changes to due to the removal of HH QRP measures 
beginning with the CY 2021 HH QRP, as outlined in section V.E. of this 
final rule with comment period.

B. ICRs Regarding the OASIS

    We believe that the burden associated with the OASIS is the time 
and effort associated with data collection and reporting. As of April 
1, 2018, there are approximately 11,623 HHAs reporting OASIS data to 
CMS.
    In section V.E.1. of this final rule with comment period, we are 
removing the Depression Assessment Conducted Measure from the HH QRP 
under measure removal Factor 1: Measure performance among HHAs is so 
high and unvarying that meaningful distinctions in improvements in 
performance can no longer be made. Removing this measure will not 
impact our collection of information because OASIS Item M1730, which is 
used to calculate this measure, is also used as a risk adjuster to 
calculate other OASIS-based outcome measures currently adopted for the 
HH QRP.\83\
---------------------------------------------------------------------------

    \83\ The OASIS-based HH QRP outcome measures that use OASIS Item 
M1730 as a risk adjuster in the calculation of the measure are: 
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring 
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167), 
Improvement in Dyspnea, Improvement in Pain Interfering with 
Activity (NQF #0177), Improvement in Management of Oral Medications 
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF 
#0178).
---------------------------------------------------------------------------

    In section V.E.2. of this final rule with comment period, we are 
removing the Diabetic Foot Care and Patient/Caregiver Education 
Implemented during All Episodes of Care Measure from the HH QRP under 
measure removal Factor 1: Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made. This measure is calculated using OASIS Item 
M2401, row a at the time point of Transfer to an Inpatient Facility 
(TOC) and Discharge from Agency--Not to an Inpatient Facility 
(Discharge). Specifically, we are removing this one data element at the 
TOC and Discharge time points.
    In section V.E.3. of this final rule with comment period, we are 
removing the Multifactor Fall Risk Assessment Conducted For All 
Patients Who Can Ambulate (NQF #0537) Measure from the HH QRP under 
measure removal Factor 1: Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made. This measure is calculated using OASIS Item 
M1910 at the time point of SOC/ROC. Specifically, we are removing this 
one data element at the SOC/ROC time point.
    In section V.E.4. of this final rule with comment period, we are 
removing the Pneumococcal Polysaccharide Vaccine Ever Received Measure 
from the HH QRP, under measure removal Factor 3: A measure does not 
align with current clinical guidelines or practice. This measure is 
calculated using OASIS Items M1051 and M1056 at the time points of TOC 
and Discharge. Specifically, we are removing these two data elements at 
the TOC and Discharge time points.
    In section V.E.5. of this final rule with comment period, we are 
removing the Improvement in the Status of Surgical Wounds Measure from 
the HH QRP under measure removal Factor 4: A more broadly applicable 
measure (across settings, populations, or conditions) for the 
particular topic is available. Removing this measure will not impact 
our collection of information because OASIS Items M1340 and M1342 are 
used as risk adjusters to calculate other OASIS-based outcome measures 
currently adopted for the HH QRP and OASIS Items M1340 and M1342 are 
also used for the Potentially Avoidable Events measure Discharged to 
the Community Needing Wound Care or Medication Assistance that is used 
by HH surveyors during the survey process.84 85
---------------------------------------------------------------------------

    \84\ The OASIS-based HH QRP outcome measures that use OASIS 
Items M1340 and M1342 as a risk adjuster in the calculation of the 
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed 
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF 
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with 
Activity (NQF #0177), and Improvement in Management of Oral 
Medications (NQF #0176).
    \85\ Measure specifications can be found in the Home Health 
Potentially Avoidable Events Measures Table on the Home Health 
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------

    In sections V.E.6. and V.E.7. of this final rule with comment 
period, we are removing the Emergency Department Use without Hospital 
Readmission during the First 30 Days of HH (NQF #2505) Measure and the 
Rehospitalization during the First 30

[[Page 56590]]

Days of HH (NQF #2380) Measure from the HH QRP beginning with the CY 
2021 HH QRP under measure removal Factor 4. A more broadly applicable 
measure (across settings, populations, or conditions) for the 
particular topic is available. Because these are both claims-based 
measures, removing them will not impact our collection of information.
    In summary, we are finalizing the net reduction of 1 data element 
at SOC, 1 data element at ROC, 3 data elements at TOC and 3 data 
elements at Discharge associated with OASIS item collection as a result 
of the measure removals from the HH QRP.
    The OASIS instrument is used for meeting the home health Conditions 
of Participation, requirements under the HH QRP, and for payment 
purposes under the HH PPS. As outlined in section III.F. of this final 
rule with comment period, to calculate the case-mix adjusted payment 
amount for the PDGM, we are finalizing our proposal to add collection 
of two current OASIS items (10 data elements) at the follow-up (FU) 
time point:
     M1033: Risk for Hospitalization (9 data elements)
     M1800: Grooming (1 data element).
    As outlined in section III.F of this final rule with comment 
period, several OASIS items will not be needed in case-mix adjusting 
the period payment for the PDGM; therefore, 19 current OASIS items (48 
data elements) are optional at the FU time point:

 M1021: Primary Diagnosis (3 data elements)
 M1023: Other Diagnosis (15 data elements)
 M1030: Therapies (3 data elements)
 M1200: Vision (1 data element)
 M1242: Frequency of Pain Interfering (1 data element)
 M1311: Current Number of Unhealed Pressure Ulcers at Each 
Stage (12 data elements)
 M1322: Current Number of Stage 1 Pressure Ulcers (1 data 
element)
 M1324: Stage of Most Problematic Unhealed Pressure Ulcer that 
is Stageable (1 data element)
 M1330: Does this patient have a Stasis Ulcer? (1 data element)
 M1332: Current Number of Stasis Ulcer(s) that are Observable 
(1 data element)
 M1334: Status of Most Problematic Stasis Ulcer that is 
Observable (1 data element)
 M1340: Does this patient have a Surgical Wound (1 data 
element)
 M1342: Status of Most Problematic Surgical Wound that is 
Observable (1 data element)
 M1400: Short of Breath (1 data element)
 M1610: Urinary Incontinence or Urinary Catheter Presence (1 
data element)
 M1620: Bowel Incontinence Frequency (1 data element)
 M1630: Ostomy for Bowel Elimination (1 data element)
 M2030: Management of Injectable Medications (1 data element)
 M2200: Therapy Need (1 data element)

    Therefore, we are finalizing the net reduction of 38 data elements 
at FU associated with OASIS item collection as a result of the 
implementation of the PDGM for CY 2020.
    In summary, as a net result of the policies we are finalizing in 
this final rule with comment period, we will be removing 1 data element 
at SOC, 1 data element at ROC, 38 data elements at FU, 3 data elements 
at TOC and 3 data elements at Discharge associated with OASIS item 
collection as a result of the measure removals from the HH QRP and the 
implementation of the PDGM starting January 1, 2020.
    We assume that each data element requires 0.3 minutes of clinician 
time to complete. Therefore, we estimate that there is a reduction in 
clinician burden per OASIS assessment of 0.3 minutes at SOC, 0.3 
minutes at ROC, 11.4 minutes at FU, 0.9 minutes at TOC and 0.9 minutes 
at Discharge.
    The OASIS is completed by RNs or physical therapists (PTs), or very 
occasionally by occupational therapists (OT) or speech language 
pathologists (SLP/ST). Data from 2016 show that the SOC/ROC OASIS is 
completed by RNs (approximately 87 percent of the time), PTs 
(approximately 12.7 percent of the time), and other therapists, 
including OTs and SLP/STs (approximately 0.3 percent of the time). We 
estimated a weighted clinician average hourly wage of $70.75, inclusive 
of fringe benefits, using the hourly wage data in Table 41. Individual 
providers determine the staffing resources necessary.
    Table 43 shows the total number of assessments submitted in CY 2017 
and estimated burden at each time point.
[GRAPHIC] [TIFF OMITTED] TR13NO18.077

    Based on the data in Table 43 for the 11,623 active Medicare-
certified HHAs in April 2018, we estimate the total average decrease in 
cost associated with changes with OASIS item collection at $5,148.94 
per HHA annually, or $59,846,101.27 for all HHAs annually. This 
corresponds to an estimated reduction in clinician burden associated 
with changes to collection of information associated with the OASIS of 
72.8 hours per HHA annually, or

[[Page 56591]]

845,881.3 hours for all HHAs annually. This burden decrease will be 
accounted for in the information collection under OMB control number 
0938-1279. We did not receive comments on collection of information 
requirements associated with the OASIS.

C. ICRs Regarding Home Infusion Therapy

    At Sec.  486.520, Plan of Care, we propose that all patients must 
have a plan of care established by a physician that prescribes the 
type, amount, and duration of infusion therapy services that are to be 
furnished. This requirement directly implements section 5012 of the 
21st Century Cures Act. Accredited home infusion therapy suppliers are 
already required by their accrediting bodies to provide all care in 
accordance with a plan of care that specifies the type, amount, and 
duration of infusion therapy services to be furnished to each patient; 
therefore this requirement will not impose a burden upon accredited 
agencies. Furthermore, all existing home infusion therapy suppliers are 
already accredited due to existing payment requirements established by 
private insurers and Medicare Advantage plans. In accordance with the 
implementing regulations of the PRA at 5 CFR 1320.3(b)(3), this 
requirement exists even in the absence of a federal requirement; 
therefore, the associated burden is not subject to the PRA. We did not 
receive any comments from the public, either in agreement or 
opposition, regarding our estimation of burden for information 
collection requirements in relation to the implementation of the home 
infusion therapy standards as delineated by section 5012 of the 21st 
Century Cures Act; therefore, we are finalizing this estimate without 
modification.
    We did not receive any comments from the public, either in 
agreement or opposition, regarding our estimation of burden for 
information collection requirements in relation to the implementation 
of the home infusion therapy standards as delineated by section 5012 of 
the 21st Century Cures Act; therefore, we are finalizing this estimate 
without modification.

D. ICRs Regarding the Approval and Oversight of Accrediting 
Organizations for Home Infusion Therapy

1. Background
    We are finalizing establish a new set of regulations related to the 
approval and oversight of accrediting organizations that accredit home 
infusion therapy suppliers. If finalized, these new regulatory 
requirements will impose burden on those new AOs that seek approval of 
their Home Infusion Therapy accreditation program. This burden will 
include, but is not limited to the time and costs associated with the 
following activities: (1) Preparation and filing of an initial 
application seeking CMS approval of the AOs home infusion therapy 
accreditation program; (2) participation in the application review 
process (that is, meetings, provide additional information and 
materials that may be required, participate in a site visit, etc.); (3) 
seeking new accreditation clients; (4) performing on-site surveys, off-
site survey audits or the performance of other types of survey 
activities; (5) participation in CMS ongoing accreditation program 
review activities; (6) performance of periodic re-accreditation 
activities; (7) investigation of complaints and performing complaint 
surveys; (8) administration of the appeals process for providers that 
have been denied accreditation; (9) staff training, in-services and 
continuing education; and (10) ensuring that surveyor staff have the 
proper education, training, and credentials.
    The following is a discussion of the potential ICR burdens 
associated with the home infusion therapy supplier accreditation 
oversight regulations and well as any PRA exceptions that may apply.
2. Applicable PRA Exception
    We believe that the information collection burden associated with 
the preparation and submission of an initial or renewal application for 
approval and designation as a home infusion therapy AO and the 
participation in other accreditation related activities does not meet 
the definition of ``collection of information'' as defined in 5 CFR 
1320.3(c) because it is ``not imposed on 10 or more persons.'' This 
information collection burden will be imposed only on those national 
AOs that accredit home infusion therapy suppliers.
    At this time, there are five CMS-approved HHA AOs that provide home 
infusion therapy accreditation as part of the deeming accreditation of 
home health agencies. These HHA AOs are The Joint Commission (TJC), the 
Accreditation Commission for Health Care (ACHC), The Compliance Team 
(TCT), the Community Health Accreditation Partner (CHAP), and the 
Healthcare Quality Association on Accreditation.
    There are three pharmacy association AOs that provide non-CMS 
approved home infusion therapy accreditation. These non-CMS approved 
Home infusion AOs are the National Association of Boards of Pharmacy, 
the Centers for Pharmacy Practice Accreditation (CPPA) and URAC).
    In this final rule with comment period, we have to require that 
these AO must apply for CMS approval of a home infusion therapy 
accreditation that is separate and distinct from its home health 
accreditation program. When we do solicit AOs to accredit home infusion 
therapy suppliers, we do not anticipate receiving more than the six 
applications which will be submitted by the existing AOs seeking 
approval of a home infusion therapy accreditation program, because this 
is a specialized area of accreditation.
    It is possible that the number of AOs that we designate to accredit 
home infusion therapy suppliers may increase to 10 or more in the 
future, when we begin accepting applications for home infusion therapy 
AOs. However, we do not anticipate that the number of AOs that will 
accredit home infusion therapy suppliers will increase to 10 or more in 
the foreseeable future.
    Should the number of AOs that accredit home infusion therapy 
suppliers rise to 10 or more, we will prepare and submit an information 
collection request (ICR) for the burden associated with the 
accreditation process, as well as obtain OMB approval, prior to 
accepting additional applications.
    We did not receive comments on these information collection 
requirements.

E. ICR Regarding Modifications to 42 CFR 488.5

    We are modifying the AO approval and oversight regulations for 
Medicare certified providers and suppliers by adding a new requirement. 
Section 488.5(a)(17)(iii) will require that the AOs for Medicare 
certified providers and suppliers include a written statement in their 
application for CMS approval agreeing that if a fully accredited and 
deemed facility in good standing provides written notification that 
they wish to voluntarily withdraw from the accrediting organization's 
CMS-approved accreditation program, the accrediting organization must 
continue the facility's current accreditation in full force and effect 
until the effective date of withdrawal identified by the facility or 
the expiration date of the term of accreditation, whichever comes 
first.
    An AO would prepare this written statement as part of the 
preparation of the initial or renewal applications they submit to CMS 
seeking initial and renewal approval of the CMS approval

[[Page 56592]]

of their accreditation program. This statement would be included in a 
written document with other required written statements. As the AO 
would already be in the process of preparing the documentation for 
their application, we believe that there would be little, if any burden 
associated with the preparation of this statements.
    We believe that it would take no more than 15 minutes for the AO to 
add this statement to the written document containing all the 
statements and affirmations that AO must submits as a condition of 
approval. We believe that this task would be performed by an 
administrative assistant. According to the U.S. Bureau of Labor 
Statistics, the mean hourly wage for an executive administrative 
assistant is $28.56 (https://www.bls.gov/oes/current/oes436011.htm). We 
estimate that the AO would incur a cost burden for wages related to the 
preparation of the required statement in the amount of $14.28 ($28.56 x 
15 minutes = $7.14) + ($7.14 for fringe benefits and overhead).
    We had also proposed to add a new requirement at Sec.  488.5(a)(7) 
to require surveyors for AOs that accredit non-certified providers and 
suppliers to take the CMS online surveyor training. However, after 
consideration of the public comments received regarding this proposal, 
we have decided not to finalize the proposal.

F. Submission of PRA-Related Comments

    We have submitted a copy of this final rule with comment period to 
OMB for its review of the rule's information collection and 
recordkeeping requirements. The requirements are not effective until 
they have been approved by OMB.
    We invite public comments on these information collection 
requirements. If you wish to comment, please identify the rule (CMS-
1689-F) and, where applicable, the ICR's CFR citation, CMS ID number, 
and OMB control number.
    To obtain copies of a supporting statement and any related forms 
for the collection(s) summarized in this notice, you may make your 
request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.
    See this rule's DATES and ADDRESSES sections for the comment due 
date and for additional instructions.

X. 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 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 
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 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 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 
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.
    Section 1895(b)(2) of the Act and section 1895(b)(3)(A) of the Act, 
as amended by section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 
respectively, require the Secretary to implement a 30-day unit of 
service, effective for CY 2020, and calculate a 30-day payment amount 
for CY 2020 in a budget neutral manner, respectively. In addition, 
section 1895(b)(4)(B) of the Act, as amended by section 51001(a)(3) of 
the BBA of 2018, requires the Secretary to eliminate the use of the

[[Page 56593]]

number of therapy visits provided to determine payment, also effective 
for CY 2020.
    Finally, the HHVBP Model applies a payment adjustment based on an 
HHA's performance on quality measures to test the effects on quality 
and expenditures.
2. Home Infusion Therapy
    Section 1861(iii) of the Act, as added by the Cures Act, sets forth 
three elements for home infusion therapy suppliers in three areas: (1) 
Ensuring that all patients have a plan of care established and updated 
by a physician that sets out the care and prescribed infusion therapy 
necessary to meet the patient-specific needs, (2) having procedures to 
ensure that remote monitoring services associated with administering 
infusion drugs in a patient's home are provided, and (3) having 
procedures to ensure that patients receive education and training on 
the effective use of medications and equipment in the home. These 
provisions serve as the basis for suppliers to participate in Medicare.
    Section 1834(u) of the Act serves as the basis for the 
establishment of a prospective payment system for home infusion therapy 
covered under Medicare. Section 1834(u)(7) of the Act, as added by BBA 
of 2018 requires the Secretary to provide a temporary transitional 
payment to 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.D. of this final rule with comment period), the 
Secretary will establish three payment categories at amounts equal to 
the amounts determined under the Physician Fee Schedule established 
under section 1848 of the Act for services furnished during CY 2019 for 
codes and units of such codes, determined without application of the 
geographic adjustment.
    Section 1834(u)(5)(B) of the Act requires the Secretary to 
designate organizations to accredit qualified home infusion therapy 
suppliers furnishing home infusion therapy no later than January 1, 
2021. 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 accrediting organization 
designated and approved by the Secretary; and meet other such 
requirements as the Secretary deems appropriate.

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.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). The net transfer impact related to the changes in payments under 
the HH PPS for CY 2019 is estimated to be $420 million (2.2 percent). 
The net transfer impact in CY 2020 related to the change in the unit of 
payment under the 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. The net transfer impact in CY 2019 related to 
the Temporary Transitional Payment for Home Infusion Therapy is 
estimated to be $48 million. The savings impacts related to the HHVBP 
model as a whole are estimated at $378 million for CYs 2018 through 
2022. Due to the modifications to OASIS item collection as a result of 
the changes to the HH QRP and the changes to the HH PPS (PDGM), both 
effective on and after January 1, 2020, we estimate that this rule 
generates $60 million in annualized cost savings, or $46 million per 
year on an ongoing basis discounted at 7 percent relative to year 2016, 
over a perpetual time horizon beginning in CY 2020. Finally, the 
estimated cost impact to each potential home infusion therapy AO is 
$35,711. The cost of $12,453 would be incurred by the home infusion AO 
for the preparation and submission of their initial application to CMS 
seeking CMS approval of the AO's home infusion therapy accreditation 
program. The AO will incur this $12,453 cost with the submission of 
their initial application and then every 6 years thereafter, with the 
submission of their renewal application. The remaining costs of 
$23,258, which represents the costs associated with the home infusion 
therapy AO`s participation in ongoing CMS AO overview, monitoring and 
program review activities will be incurred on a bi-yearly basis.
    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.

C. Anticipated Effects

    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 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

[[Page 56594]]

reach a threshold of 3 to 5 percent or more of total revenue or total 
costs. The majority of HHAs' visits are Medicare paid visits and 
therefore the majority of HHAs' revenue consists of Medicare payments. 
Based on our analysis, we conclude that the policies in this final rule 
with comment period will result in an estimated total impact of 3 to 5 
percent or more on Medicare revenue for greater than 5 percent of HHAs. 
Therefore, the Secretary has determined that this HH PPS final 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 604 of RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a metropolitan statistical area and has fewer 
than 100 beds. This rule is not applicable to hospitals. Therefore, the 
Secretary has determined this final rule with comment period would 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 2018, 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 final rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts State law, or otherwise has Federalism 
implications. We have reviewed this final rule with comment period 
under these criteria of Executive Order 13132, and have determined that 
it will not impose substantial direct costs on state or local 
governments. If regulations impose administrative costs on private 
entities, such as the time needed to read and interpret this final rule 
with comment period, we must estimate the cost associated with 
regulatory review. Due to the uncertainty involved with accurately 
quantifying the number of entities that would review the rule, we 
assume that the total number of unique commenters on this year's final 
rule would be the similar to the number of reviewers of last year's 
final 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 final rule with comment period. We also recognize 
that different types of entities are in many cases affected by mutually 
exclusive sections of this final rule with comment period, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule. 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 $107.38 per hour, 
including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed of 250 words 
per minute, we estimate that it would take approximately 5.3 hours for 
the staff to review half of this final rule with comment period, which 
consists of approximately 160,000 words. For each HHA that reviews the 
rule, the estimated cost is $569.11 (5.3 hours x $107.38). Therefore, 
we estimate that the total cost of reviewing this regulation is 
$767,729.39 ($569.11 x 1,349 reviewers).
1. HH PPS
a. HH PPS for CY 2019
    The update set forth in this rule applies to Medicare payments 
under HH PPS in CY 2019. Accordingly, the following analysis describes 
the impact in CY 2019 only. We estimate that the net impact of the 
policies in this rule is approximately $420 million in increased 
payments to HHAs in CY 2019. We applied a wage index budget neutrality 
factor and a case-mix weight budget neutrality factor to the rates as 
discussed in section III.C.3 of this final rule with comment period. 
Therefore, the estimated impact of the 2019 wage index and the 
recalibration of the case-mix weights for CY 2019 is $0 million. The 
$420 million increase reflects the distributional effects of the CY 
2019 home health payment update of 2.2 percent ($420 million increase), 
a 0.1 percent increase in payments due to the new lower FDL ratio, 
which will increase outlier payments in order to target to pay no more 
than 2.5 percent of total payments as outlier payments ($20 million 
increase) and a 0.1 percent decrease in payments due to the new rural 
add-on policy mandated by the BBA of 2018 for CY 2019 ($20 million 
decrease). The $420 million in increased payments is reflected in the 
last column of the first row in Table 44 as a 2.2 percent increase in 
expenditures when comparing CY 2018 payments to estimated CY 2019 
payments.
    With regard to options for regulatory relief, the rural add-on 
policy for CYs 2019 through 2022 is statutory and we do not have the 
authority to alter the methodology used to categorize rural counties or 
to revise the rural add-on percentages.
b. HH PPS for CY 2020 (PDGM)
    We estimate no net impact of the policies related to the 
implementation of the PDGM for the CY 2020 HH PPS, as the transition to 
the 30-day unit of payment is required to be budget neutral. However, 
since the PDGM eliminates the use of therapy thresholds as a factor in 
determining payment, HHAs that provide more nursing visits, and thus 
experience lower margins under the current payment system which may 
incentivize overutilization of therapy, may experience higher payments. 
Conversely, HHAs that provide more therapy visits compared to nursing 
visits, and thus may profit more from the current payment system, may 
experience lower payments.
c. Elimination of Recertification Requirement To Estimate How Much 
Longer Home Health Services Will Be Required
    Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act require, as a 
condition of payment, that a physician must certify (and recertify, 
when home health services are furnished over a period of time) that the 
individual is eligible for home health services. The regulations at 
Sec.  424.22(b)(2) set forth the content and basis for recertification 
requirements and states that the recertification statement must 
indicate the continuing need for services and estimate how much longer 
the services will be required. This requirement has been longstanding 
policy that predates the Paperwork Reduction Act of 1995 requirements. 
Therefore, there is no corresponding Collection of Information that was 
submitted to the Office of Management and Budget (OMB) for review and 
approval for the burden estimate for the recertification requirement 
that the certifying physician must estimate how much longer home health 
services will be required.

[[Page 56595]]

    In section III.G. of this final rule with comment period, we 
eliminate the regulatory requirement as set forth at 42 CFR 
424.22(b)(1), that the certifying physician, as part of the 
recertification process, include an estimate of how much longer home 
health services will be required at each home health recertification. 
While all other recertification content requirements under Sec.  424.22 
will remain unchanged, the certifying physician would not be required 
to provide his/her estimation as to how much longer the patient will 
require home health services on recertifications on and after January 
1, 2019. Therefore, we believe this would result in a reduction of 
burden for certifying physicians by reducing the amount of time 
physicians spend on the recertification process and we are providing an 
estimate on the reduction in burden in this final rule with comment 
period. All salary information is based on the May 2017 wage data for 
physicians and surgeons from the Bureau of Labor Statistics (BLS) 
website at (https://www.bls.gov/oes/current/oes291069.htm) and includes 
a fringe benefits and overhead worth 100 percent of the base salary.
    Using CY 2017 claims, we estimate that of the total number of 
Medicare home health claims (5.8 million), 37 percent were 
recertifications (2.1 million) completed by 284,615 certifying 
physicians.\86\ Of those 2.1 million recertifications, we estimate that 
the time needed to recertify patient eligibility will decrease by 2 
minutes per recertification with a total reduction of 69,930 physician 
hours for all recertifications as a result of eliminating the time 
estimation statement. Based on the physician's hourly wage of $203.26 
as described previously ($101.63 with 100 percent fringe benefits and 
overhead), this results in an overall annualized cost savings of $14.2 
million beginning in CY 2019.
---------------------------------------------------------------------------

    \86\ CY 2017 OASIS assessments matched to Medicare FFS claims 
(as of March 2, 2018).
---------------------------------------------------------------------------

2. HHVBP Model
    Under the HHVBP Model, the first payment adjustment applies in CY 
2018 based on PY1 (2016) data and the final payment adjustment will 
apply in CY 2022 based on PY5 (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 CY 2017 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 $378 million (81 FR 76795). We do not 
believe the changes finalized in this rule would affect the prior 
estimates.
3. Home Infusion Therapy
a. Health and Safety Standards
    Section 5012 of the Cures Act (Pub. L. 114-255), which amended 
section 1861(s)(2) of the Social Security Act (the Act), established a 
new Medicare home infusion therapy benefit. Section 1861(iii) of the 
Act, as added by section 5012 of the Cures Act defines, the Medicare 
home infusion therapy benefit and covers professional services 
including nursing services, training and education, and remote 
monitoring and monitoring services associated with administering 
certain infusion drugs in a patient's home. This benefit would ensure 
consistency in coverage for home infusion benefits for all Medicare 
beneficiaries. Section 1861(iii) of the Act, as added by the Cures Act, 
sets forth elements for home infusion therapy suppliers in three areas: 
(1) Ensuring that all patients have a plan of care established and 
updated by a physician that sets out the care and prescribed infusion 
therapy necessary to meet the patient-specific needs; (2) having 
procedures to ensure that remote monitoring services associated with 
administering infusion drugs in a patient's home are provided; and (3) 
having procedures to ensure that patients receive education and 
training on the effective use of medications and equipment in the home.
    We implement the following requirements for home infusion therapy 
suppliers--
     Ensure that all patients must have a plan of care 
established by a physician that prescribes the type, amount and 
duration of infusion therapy services that are furnished. The plan of 
care would specify the care and services necessary to meet the patient 
specific needs.
     Ensure that the plan of care for each patient is 
periodically reviewed by the physician.
     Ensure that patients have infusion therapy support 
services at all times through the provision of professional services, 
including nursing services, furnished in accordance with the plan of 
care on a 7-day-a-week, 24-hour-a-day schedule.
     Provide patient training and education.
     Provide remote monitoring and monitoring services for the 
provision of home infusion therapy and home infusion drugs.
     All home infusion therapy suppliers must provide home 
infusion therapy services in accordance with nationally recognized 
standards of practice, and in accordance with all applicable state and 
federal laws and regulations (including the applicable provisions in 
the Federal Food, Drug, and Cosmetic Act).
    All current standards established by AOs already address the 
requirements set forth in this rule. Furthermore, all existing home 
infusion therapy suppliers are already accredited by an existing AO for 
home infusion therapy to meet requirements established by private 
insurers and Medicare Advantage plans. Therefore, we assume that there 
would be no new burden imposed on home infusion therapy suppliers in 
order to meet the health and safety standards. Additionally, we assume 
that these health and safety provisions would not impose a new burden 
on home infusion therapy AOs that are likely to apply to be Medicare 
approved AOs for home infusion therapy because their existing standards 
would already meet or exceed those that would be established in this 
rule.
b. Home Infusion Therapy Payment
    We estimate that the net impact of the policies in this rule is 
approximately $48 million (not including $12 million in beneficiary 
cost-sharing) in increased Medicare payments to home infusion suppliers 
in CY 2019. This increase reflects the cost of providing infusion 
therapy services to existing Medicare beneficiaries who are receiving 
DME home infusion therapy (at a 4-hour rate), as the temporary 
transitional payment applies only to existing Medicare eligible home 
infusion suppliers (that is, DME suppliers that are enrolled as 
pharmacies that provide external infusion pumps and supplies are 
considered eligible home infusion suppliers). Prior to the 
implementation of the temporary transitional payment, home infusion 
suppliers have not been separately paid for providing these services 
under the DME benefit. For the temporary transitional payment we do not 
anticipate an increase in beneficiaries receiving home infusion therapy 
services as referral patterns are not likely to change significantly 
due to the inability for other provider types (for example, physicians, 
HHAs) to become home infusion therapy suppliers prior to CY 2021 and 
given that existing DME suppliers already provide home infusion therapy 
services without separate reimbursement.
c. Accreditation of Quality Home Infusion Therapy Suppliers
    The requirement for accreditation of home infusion therapy 
suppliers will

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cause both the home infusion therapy AOs and the home infusion therapy 
suppliers to incur costs related to the accreditation process. This 
section provides a discussion of the estimated time and cost burdens 
that home infusion therapy suppliers may incur as part of the 
accreditation process. It also discusses the estimated time and cost 
burdens that may be incurred by the home infusion therapy AOs to comply 
with the home infusion therapy AO approval and oversight regulations at 
Sec. Sec.  488.1010 through 488.1050. As the following discussion 
demonstrates, we have estimated that each home infusion therapy AO 
would incur an estimated cost burden in the amount of $23,258 for 
compliance with the home infusion therapy AO approval and oversight 
regulations at Sec. Sec.  488.1010 through 488.1050.
(1) Burden Incurred by Home Infusion Therapy AOs
    Section 1834(u)(5)(B) of the Act requires the Secretary to 
designate AOs to accredit suppliers furnishing home infusion therapy 
not later than January 1, 2021. To date, we have not solicited nor 
approved any AOs to accredit home infusion therapy suppliers as 
required by section 1834(u)(5)(B) of the Act.
    The AOs that respond to the solicitation notice would be required 
to submit an application to CMS requesting CMS-approval of a home 
infusion therapy accreditation program for Medicare. If CMS approves 
the AOs application, the home infusion therapy AO would also be 
required to meet, on an ongoing basis, the requirements set forth 
iSec. Sec.  488.1010 through 488.1050. The following is a discussion of 
the burden associated with specific sections of the home infusion 
therapy AO approval and oversight regulations at Sec. Sec.  488.1010 
through 488.1050.
(a) Burden for Home Infusion Therapy AOs Associated With Sec.  488.1010
    The AOs that accredit home infusion therapy suppliers would incur 
time and costs burdens associated with the preparation of the 
application they submit to CMS requesting approval of their home 
infusion therapy accreditation program. This would include the 
preparation, gathering or obtaining of all the documentation required 
in Sec.  488.1010(a)(1) through (24).
    If the AO has never submitted an application to CMS, we estimate 
that it would take approximately 70 hours of time to gather, obtain or 
prepare all documentation required by Sec.  488.1010(a)(1) through 
(23). However, for an existing AO that has previously submitted an 
application to CMS for any type of accreditation program, we estimate 
that it would take approximately 45 hours to gather, obtain or prepare 
all required documentation. We believe that it would take less time for 
an AO that has previously submitted an application to CMS to prepare an 
application requesting approval of a home infusion therapy 
accreditation program because this AO would already be familiar with 
the application process and requirements. The application requirements 
for home infusion therapy AOs, set forth at Sec.  488.1010(a)(1) 
through (23), are consistent with those for Medicare-certified 
providers and suppliers which are set forth at Sec.  488.5.
    The home infusion therapy AO would incur costs associated with the 
preparation and submission of the home infusion therapy accreditation 
program application. The home infusion therapy AO would incur costs for 
the wages of all AO staff that work on the preparation of the 
application. We estimate that the AO would have 2 staff work on the 
preparation of the application. We believe that the AO staff that works 
on the AOs application would be clinicians such as registered nurses or 
medical or health services manager. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm) and the mean hourly 
wage for a medical or health services manager is $53.69 (https://www.bls.gov/oes/current/oes119111.htm). Therefore, we estimate that the 
home infusion therapy AO would incur wages for 45 hours of time by a 
registered nurse and wages for 45 hours of time by a medical or health 
services manager in the amount of $8,014.50 (45 hours x $35.36 per hour 
= $1,591.20) + (45 hours x $53.69 = $2,416.05 per hour) + ($4,007.25 
for fringe benefits and overhead).
    As stated previously, we estimate that it would take approximately 
70 hours for an AO that has never submitted an application before to 
prepare and submit their home infusion therapy accreditation program 
application to CMS. We estimate that the home infusion therapy AO would 
incur wages for 70 hours of time by a registered nurse and 70 hours of 
time by a medical or health services manager in the amount of $12,453 
(70 hours x $35.36 per hour = $2,475.20) + (70 hours x $53.59 = 
$3,751.30) + ($6,226,50 for fringe benefits and overhead).
    In addition, AOs are required to submit 2 hard copies of their 
application to CMS in notebooks with dividers and an electronic copy of 
their application on a thumb drive. Because of this requirement, the 
home infusion therapy AO would incur costs for the notebooks, dividers, 
thumb drive, photocopying, paper and ink, and postage costs for mailing 
the notebooks with the hard copies of the application to the CMS 
Central Office. We estimate that these costs would be no more than 
$250.
    At this time, there are five HHA AOs that accredit home infusion 
therapy suppliers as part of the deeming accreditation of a home health 
accreditation program (that is, The Joint Commission (TJC), 
Accreditation Commission for Health Care (ACHC), The Compliance Team 
(TCT), Community Health Accreditation Partner (CHAP), Healthcare 
Quality Association on Accreditation (HQAA)). The other three home 
infusion therapy AOs are pharmacy associations that provide non-
Medicare approved accreditation to home infusion therapy suppliers. 
(That is, the National Association of Boards of Pharmacy, the Center 
for Pharmacy Practice Accreditation (CPPA) and URAC). The home infusion 
therapy accreditation programs offers by these 8 AO have not been 
approved under the requirements of section 1834(u)(5)(A) of the Act. 
Therefore, in order for the home infusion therapy suppliers accredited 
by these AOs to continue to receive payment for the home infusion 
therapy services furnished to Medicare beneficiaries, these AOs must 
obtain Medicare approval for a home infusion therapy accreditation 
program. If all of these eight AOs were to submit applications to CMS 
for approval of a home infusion therapy accreditation program, the cost 
incurred across all of these potential home infusion therapy AOs for 
the preparation and submission of their applications would be $64,116 
($4,007.25 x 8 AOs = $32,058) + ($32,058 for fringe benefits and 
overhead).
    To obtain this CMS approval, these AOs would be required to submit 
an application to CMS seeking approval of a home infusion therapy 
accreditation program that meets the requirements set forth in the new 
home infusion therapy AO approval and oversight regulations set forth 
at Sec.  488.1010(a)(1) through (a)(24) and the new home infusion 
therapy health and safety regulations at 42 CFR part 466, subpart I. We 
have further that the home infusion therapy accreditation programs 
submitted to CMS for approval by the existing home infusion therapy AOs 
be consistent with the requirements of section 5102 of the 21st Century 
CURES Act and section 1861(iii) of the Act. We would also require that 
the home infusion therapy

[[Page 56597]]

programs submitted by these AOs be separate and distinct from the AOs 
home health deeming accreditation program.
    The AOs that currently provide home infusion therapy accreditation 
would incur the time and costs associated with the preparation of the 
CMS application and required supporting documentation. We estimate that 
it would take these AOs approximately 45 hours to prepare their 
applications and supporting documentation because they have previously 
submitted applications for approval of their home health accreditation 
programs. The existing AOs that accredit home infusion therapy 
suppliers would also incur costs for the wages for all AO staff 
involved with the preparation and submission of the application. The AO 
would also incur costs for printing the hard copies of the application, 
ink and paper, notebooks and dividers, and postage.
(b) Burden for Home Infusion Therapy AOs Associated With Sec.  488.1030
    In accordance with Sec.  488.1030(b) CMS would perform a 
comparability review if CMS makes changes to the home infusion therapy 
AO approval and oversight regulations or home infusion therapy health 
and safety regulation. The purpose of the comparability review is to 
allow CMS to assess the equivalency of a home infusion therapy AO's 
accreditation standards with the comparable Medicare home infusion 
therapy accreditation requirements after CMS imposes new or revised 
Medicare home infusion therapy accreditation requirements.
    Section 488.1030(b)(1) would provide that if CMS were to make 
changes to the home infusion therapy AO approval and oversight 
accreditation regulations or the home infusion therapy health and 
safety regulations, CMS would send a written notice of the changes to 
the home infusion therapy AOs. Section 488.1030(b)(2) would provide 
that CMS would provide a deadline of not less than 30 day by which the 
AO must submit its revised home infusion therapy accreditation program 
standards to CMS.
    Section 488.1030(b)(2) would require the home infusion therapy AOs 
to revise their home infusion therapy accreditation standards so as to 
incorporate the changes made by CMS. The AO must submit their revised 
home infusion therapy accreditation program standards to CMS by the 
deadline specified in CMS' written notice. The AO may submit a request 
for an extension of the submission deadline, so long as the request is 
submitted prior to the original submission deadline.
    The home infusion therapy AOs would incur a time burden associated 
with the time required for the AO staff to review CMS' notice of the 
revisions to the home infusion therapy AO approval and oversight 
accreditation standards or home infusion therapy health and safety 
standards. We estimate that it would take no more than 1 hour for the 
AO to review the notice from CMS notifying the AO of the changes to the 
AO approval and oversight regulations or health and safety regulation.
    The home infusion therapy AOs would incur a cost burden for the 
wages of the AO staff that are involved with reviewing the CMS notice 
and the preparation of the home infusion therapy AO's revised 
accreditation program standards. We believe that the AO staff that 
would review the notice from CMS regarding changes to the CMS home 
infusion therapy regulations would be clinicians such as registered 
nurses. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a non-industry specific registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the home 
infusion therapy AO would incur a cost burden in the amount of $70.72 
for the preparation of the response to CMS (1 hour x $35.36 per hour = 
$35.36) + ($35.36 for fringe benefits and overhead).
    The home infusion therapy would also incur a cost burden for the 
wages of the AO staff for the time spent preparing the AOs revised home 
infusion therapy accreditation standards. There is uncertainty around 
our estimate of this cost because the amount of wages incurred would be 
dependent on the amount of time spent by the AO staff preparing the AOs 
revised accreditation standards.
    We believe that the AO staff that would prepare the home infusion 
therapy AOs revised home infusion therapy accreditation standards would 
be a clinician such as registered nurses. According to the U.S. Bureau 
of Labor Statistics, the mean hourly wage for a non-industry specific 
registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). If we were to estimate that it would take 5 hours for 
the home infusion therapy AO to prepare the revised home infusion 
therapy accreditation standards, the estimated cost burden to the AO 
would be $353.60 (5 hours x $35.36 per hour = $176.80) + ($176.80 for 
fringe benefits and overhead).
    At this time, there are five HHA AOs that accredit home infusion 
therapy suppliers as part of the deeming accreditation of a home health 
accreditation program (that is, The Joint Commission (TJC), 
Accreditation Commission for Health Care (ACHC), The Compliance Team 
(TCT), Community Health Accreditation Partner (CHAP), Healthcare 
Quality Association on Accreditation (HQAA)). The other three home 
infusion therapy AOs are pharmacy associations that provide non-
Medicare approved accreditation to home infusion therapy suppliers 
(that is, the National Association of Boards of Pharmacy, the Center 
for Pharmacy Practice Accreditation (CPPA) and URAC). The home infusion 
therapy accreditation programs offers by these 8 AO have not been 
approved under the requirements of section 1834(u)(5)(A) of the Act. If 
all of these eight AOs were to submit applications to CMS for approval 
of a home infusion therapy accreditation program, the cost incurred 
across all of these AOs for the preparation of revised accreditation 
standards would be $2,828.80 ($176.80 x 8 AOs = $1,414.40) + ($1,414.40 
for fringe benefits and overhead). As provided by Sec.  488.1030(b)(4), 
a home infusion therapy AO may request an extension of the deadline by 
which they must submit their revised accreditation home infusion 
therapy standards, so long as the extension request is submitted prior 
to the submission deadline. If the home infusion therapy AO requested 
an extension of the submission deadline, the AO would incur burden for 
the time required to prepare and submit the deadline extension request, 
however, we believe this burden would be minimal. We believe that the 
extension request could be sent in the form of an email to CMS, would 
consist of no more than a few paragraphs and would take no more than 15 
minutes to prepare and send.
    The AO would incur a cost burden for the wages for the AO staff who 
prepares the extension request. We believe that this email would be 
sent by an administrative assistant. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for an executive administrative 
assistant is $28.56 (https://www.bls.gov/oes/current/oes436011.htm). We 
estimate that the AO would incur a cost burden for wages related to the 
preparation and sending of the extension request to CMS in the amount 
of $14.28. ($28.56 x 15 minutes = $7.14) + ($7.14 for fringe benefits 
and overhead).
    At this time, there are eight AOs that accredit home infusion 
therapy suppliers (that is--The Joint Commission (TJC), Accreditation 
Commission for Health Care (ACHC), The Compliance Team (TCT),

[[Page 56598]]

Community Health Accreditation Partner (CHAP), Healthcare Quality 
Association on Accreditation (HQAA), National Association of Boards of 
Pharmacy), the Center for Pharmacy Practice Accreditation (CPPA) and 
URAC. If all of these eight AOs were to submit applications to CMS for 
approval of a home infusion therapy accreditation program, they could 
become CMS-approved home infusion therapy AOs. It is unlikely that all 
of the AOs would submit a request for an extension of the deadline to 
submit their revised accreditation standards to CMS. However, if this 
were to occur, the cost incurred across all of these AOs for the 
preparation of the extension requests by each home infusion therapy AO 
would be $114.24 ($7.14 x 8 AOs = $57.12) + ($57.12 for fringe benefits 
and overhead).
    Section Sec.  488.1030(b)(7) would provide that if CMS were to make 
significant substantial changes to the home infusion therapy AO 
approval and oversight accreditation standards or the home infusion 
therapy health and safety standards, we may require the home infusion 
therapy AOs to submit a new application for approval of their revised 
home infusion therapy accreditation programs. If this were to occur, 
the home infusion therapy AOs would incur a time burden for the time 
associated the preparation of the AOs new application.
    We estimate that it would take the home infusion therapy AO 
approximately 45 hours to prepare and submit their new application to 
CMS. This would include the time and costs required to gather and 
prepare the required supporting documentation to go with the 
application. We believe that the home infusion therapy AOs would 
already be familiar with the CMS application process and would be able 
to use their previous application and supporting documentation with 
updates, therefore, the reapplication process would be less burdensome.
    The home infusion therapy AO would also incur costs associated with 
the preparation and submission of a new application. The home infusion 
therapy AO would incur costs for the wages of all AO staff that work on 
the preparation of the application. We estimate that the AO would have 
2 staff persons work on the preparation of the application. 
Furthermore, we believe that the AO staff that works on the AOs 
application would be clinicians such as a registered nurse and a 
medical or health services manager. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for a non-industry specific 
registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm) and the mean hourly wage for a medical or health 
services manager is $53.69 (https://www.bls.gov/oes/current/oes119111.htm). Therefore, we estimate that the home infusion therapy 
AO would incur wages for 45 hours of time by a registered nurse and 45 
hours of time by a medical or health services manager in the amount of 
$8,014.50 (45 hours x $35.36 per hour = $1,591.20) + (45 hours x $53.69 
= $2,416.05 per hour) + ($4,007.25 for fringe benefits and overhead). 
The cost across all the 6 potential home infusion therapy AOs would be 
$48,087 ($4,007.25 x 6 AOs = $24,043.50) + ($24,043.50 for fringe 
benefits and overhead).
    In addition, AOs are required to submit 2 hard copies of their 
application to CMS in notebooks with dividers and an electronic copy of 
their application on a thumb drive. Because of this requirement, the 
home infusion therapy AO would incur costs for the notebooks, dividers, 
thumb drive, photocopying, paper and ink, and postage costs for mailing 
the notebooks with the hard copies of the application to the CMS 
Central Office. We estimate that these costs would be no more than 
$250.
    In accordance with Sec.  488.1030(c), CMS will perform a standards 
review when the home infusion therapy AO makes updates to its 
accreditation standards and surveys processes. Section 488.1030(c)(1) 
would require that when a home infusion therapy AO proposed to adopt 
new or revised accreditation standards, requirements or changes in its 
survey process, the home infusion therapy AO must submit its revised 
accreditation standards and survey processes to CMS for review, at 
least 60 days prior to the implementation date of the revised 
standards. Section 488.1030(c)(3) would require that the home infusion 
therapy AO provide CMS with a detailed description of the changes that 
are to be made to the AO's home infusion therapy accreditation 
standards, requirements and survey processes and a detailed crosswalk 
(in table format) that states the exact language of the organization's 
revised accreditation requirements and the applicable Medicare 
requirements for each. Section 488.1030(c)(4) would provide that CMS 
must provide a written notice to the home infusion therapy accrediting 
organization which states whether the home infusion therapy 
accreditation program, including the revisions, continues or does not 
continue to meet or exceed all applicable Medicare home infusion 
therapy requirements within 60 days of receipt of the home infusion 
therapy accrediting organization's changes. Section 488.1030(c)(5) 
would provide that if a home infusion therapy AO implements changes 
that have neither been determined nor deemed by CMS to be comparable to 
the applicable Medicare home infusion therapy requirements, CMS may 
open a home infusion therapy accreditation program review in accordance 
with Sec.  488.1030(c) or (d).
    The burden to the home infusion therapy AO associated with the 
standards review includes the time required for the home infusion 
therapy AO to prepare its revised accreditation standards and detailed 
crosswalk for submission to CMS and submit them to CMS for review. This 
burden would also include the time required for the AO staff to read 
and respond to CMS' written response. It is important to note that we 
do not include in our burden estimate the time that would be spent by 
the home infusion therapy AO in making voluntary revisions to their 
accreditation standards that are not required by CMS nor prompted by a 
regulatory change.
    The home infusion therapy AO would also incur costs for the wages 
of the AO staff involved with the preparation of the AO's revised home 
infusion therapy accreditation standards and the detailed crosswalk for 
submission to CMS. The AO would also incur costs for wages for the time 
the AO staff spent reviewing CMS' response. However, the AO could send 
their revised accreditation standards to CMS via email, therefore the 
AO would not incur costs for postage.
    We are not able to accurately estimate the total time and cost 
burden associated with the standards review because the time required 
for the home infusion therapy AO to prepare its revised home infusion 
therapy accreditation standards and detailed crosswalk would depend on 
the extent of the revision the AO has made to its home infusion therapy 
accreditation standards or survey processes. The burden would also 
depend of the content and length of CMS' response letter. However, we 
do estimate that the preparation of the home infusion therapy AOs 
revised accreditation standard and detailed crosswalk for submission to 
CMS would take no less than 5 hours.
    We believe that the AO staff that would prepare the home infusion 
therapy AOs revised home infusion therapy accreditation standards and 
detailed crosswalk for submission to CMS would be clinicians such as 
registered nurses. According to the U.S.

[[Page 56599]]

Bureau of Labor Statistics, the mean hourly wage for a non-industry 
specific registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, if we were to estimate that this task would 
take 5 hours to complete, the cost burden to the home infusion therapy 
would be $353.60 (5 hours x $35.36 per hour = $176.80) + ($176.80 for 
fringe benefits and overhead).
    We further estimate that it would take the home infusion therapy AO 
approximately 30 minutes for the home infusion therapy AO to review the 
CMS response to their submission of the revised home infusion therapy 
accreditation standards and detailed crosswalk. We believe that a 
clinician such as a registered nurse would review the CMS response 
letter. Therefore, the cost burden to the home infusion therapy AO 
associated with this task would be $53.04 (45 minutes x $35.36 per hour 
= $26.52) + ($26.52 for fringe benefits and overhead).
    It is important to note that we have not calculated this burden 
across all of the potential home infusion therapy AOs. We have not done 
so because the submission of revised home infusion therapy 
accreditation standards by a home infusion therapy AO would only occur 
on an occasional basis and would never be done by all 6 potential AOs 
at the same time.
    In accordance with Sec.  488.1030(d), CMS may perform a home 
infusion therapy accreditation program review if a comparability, 
performance, or standards review reveals evidence of substantial non-
compliance of a home infusion therapy AO's CMS-approved home infusion 
therapy accreditation program with the requirements of the home 
infusion therapy AO approval and oversight regulation at 42 CFR part 
488, subpart L. If a home infusion therapy accreditation program review 
is initiated, CMS will provide written notice to the home infusion 
therapy AO indicating that its CMS-approved accreditation program 
approval may be in jeopardy and that a home infusion therapy 
accreditation program review is being initiated. The notice would 
provide all of the following information:
     A statement of the instances, rates or patterns of non-
compliance identified, as well as other related information, if 
applicable.
     A description of the process to be followed during the 
review, including a description of the opportunities for the home 
infusion therapy accrediting organization to offer factual information 
related to CMS' findings.
     A description of the possible actions that may be imposed 
by CMS based on the findings of the home infusion therapy accreditation 
program review.
     The actions the home infusion therapy accrediting 
organization must take to address the identified deficiencies.
     A timeline for implementation of the home infusion therapy 
accrediting organization's corrective action plan, not to exceed 180 
calendar days after receipt of the notice that CMS is initiating a home 
infusion therapy accreditation program review.
    Section 488.1030(d)(3) would provide that CMS will monitor the 
performance of the AO's home infusion therapy and the implementation of 
the corrective action plan during a probation period of up to 180 days. 
Section 488.1030(d)(4) would provide that if CMS determines, as a 
result of the home infusion therapy accreditation program review or a 
review of an application for renewal of the accrediting organizations 
existing CMS-approved home infusion therapy accreditation program, that 
the home infusion therapy accrediting organization has failed to meet 
any of the requirements of the regulations at Sec. Sec.  488.1010 
through 488.1050, CMS may place the home infusion therapy AO's CMS-
approved home infusion therapy accreditation program on an additional 
probation period of up to 180 calendar days subsequent to the period 
described in Sec.  488.1030(d)(1)(iv).
    The time burden associated with the home infusion therapy 
accreditation program review includes the time burden associated with 
the AO's review of CMS' written notice which indicates that the home 
infusion therapy AO's CMS-approved accreditation program approval may 
be in jeopardy and that a home infusion therapy accreditation program 
review is being initiated. The time required for the review of the CMS 
letter will depend on the length of CMS' finding. However, we estimate 
it would take no more than 60 minutes to review this letter.
    The AO would incur costs for the wages of the AO staff who performs 
the review of the CMS letter. We believe that an AO staff person with a 
clinical background such as a registered nurse would review the CMS 
letter. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, we estimate that the cost burden to 
the home infusion therapy AO associated with the review of the CMS 
letter would be approximately $70.72 (1 hour x $35.36 = $35.36) + 
($35.36 for fringe benefits and overhead).
    There is further burden associated with the requirement that the AO 
prepare and submit a written response to the CMS letter and a 
corrective action plan. However, we are unable to accurately estimate 
the time burden associated with this task because the amount of time 
required for the home infusion therapy AO to prepare the response 
letter and corrective plan would be dependent on the number and type of 
findings identified in CMS' letter.
    However, we believe that an AO staff person with a clinical 
background such as a registered nurse would prepare the home infusion 
therapy AO's written response to the CMS letter and a corrective action 
plan. According to the U.S. Bureau of Labor Statistics, the mean hourly 
wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). If we were to estimate that it would take the home 
infusion therapy AO 3 hours to prepare and submit a written response to 
the CMS letter and a corrective action plan, the estimated cost burden 
to the home infusion therapy AO associated with this task would be 
$212.16 (3 hours x $35.36 = $106.08) + ($106.08 for fringe benefits and 
overhead). Section 488.1030(d)(2) provides that CMS would review and 
approve the AO's plan of correction within 30 days of receipt. If CMS 
requires the home infusion therapy AO to make changes to their 
corrective action plan as a condition of approval, the AO would incur 
burden for the time required to make the required revisions to their 
plan of correction and resubmit it to CMS.
    The home infusion therapy AO would incur a time burden for the time 
spent by the AO staff making corrections to the AOs corrective action 
plan. We are unable to accurately estimate how long it would take for 
the AO to revise its corrective action plan because the revision to be 
made to the corrective action plan would be dependent on the extent of 
the correction requested by CMS.
    However, we believe that an AO staff person with a clinical 
background such as a registered nurse would make the corrections to the 
AOs corrective action plan. According to the U.S. Bureau of Labor 
Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm). So, if we were to 
estimate that it would take the home infusion therapy AO 2 hours to 
prepare and submit a written response to the CMS letter and make any 
necessary revision to the corrective action plan, the estimated cost 
burden to the home

[[Page 56600]]

infusion therapy AO associated with this task would be $141.44 (2 hours 
x $35.36 per hour = $70.72) + ($70.72 for fringe benefits and 
overhead). During the 180 day probationary period, CMS is likely to 
require the home infusion therapy AO to submit periodic progress 
reports and participate in periodic telephone to monitor the home 
infusion therapy AOs progress. The home infusion therapy AO would incur 
burden for the time required to prepare and submit an initial progress 
report. We estimate that the initial progress report would take 
approximately one hour to prepare. We further estimate that the burden 
associated with the preparation and submission of subsequent progress 
reports would be less than that for the initial progress report because 
the AO would be able to modify or update their initial or previous 
progress report. We estimate that it would take approximately 1 hour 
for the AO staff to prepare the initial progress report and 30 minutes 
for the AO staff to prepare subsequent progress reports. If CMS were to 
require the AO to submit one progress report per month during the 
entire 180 day probation period (6 months), the AO would have to submit 
1 initial progress report and 5 subsequent progress reports. Therefore, 
we estimate that the AO would incur a time burden in the amount of 3.5 
hours for the submission of all progress reports during the 180 day 
probation period. The AO would also incur a cost burden for the wages 
of the AO staff person who is involved in the preparation and 
submission of the progress reports. We believe that the initial and 
subsequent progress reports would be prepared by person with a clinical 
background such as a registered nurse. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm). We estimate that the 
home infusion therapy AO would incur a cost burden in the amount of 
$247.52 for the preparation of the progress reports during the 180 day 
probation period (3.5 hours x $35.36 per hour = $123.76) + ($123.76 for 
fringe benefits and overhead).
    The home infusion therapy AO would also incur burden associated 
with the time required to participate in the periodic phone calls with 
CMS. We are not able to accurately estimate the amount of time that 
would be required for these periodic phone calls because we do not know 
how often the AO would be required to participate in phone calls with 
CMS or how long these phone calls would last. However, we do not 
believe that these phone calls would be held more often that monthly or 
last more than one hour. The AO would incur costs for the wages of all 
AO staff that participate in the periodic telephone calls. We are not 
able to accurately estimate the total cost burden for wages that would 
be incurred by the home infusion therapy AO at this time, because we do 
not know who from the AO would be attending these meetings.
    If we were to estimate that these phone calls were to be held on a 
monthly basis during the 180 day probation period for a period of one 
hour period per call, the home infusion therapy AO would incur a time 
burden in the amount of 6 hours per each staff member that participates 
in these phone calls. We believe that the AO would have a minimum of 3 
staff that are clinicians, such as registered nurses, participate on 
the call. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/ooh/healthcare/registered-nurses.htm). Therefore, the cost burden to the 
home infusion therapy AO for participation in the monthly telephone 
calls would be $1,272.96 ((3 AO staff x $35.36 per hour = $106.08 per 
call per all staff/$106.08 per call per all staff x 6 calls = $636.48 
total wages per all staff per all calls) + ($636.48 for fringe benefits 
and overhead)).
    At or near the end of the first 180 day probationary period, CMS 
will make a decision as to whether the home infusion therapy AO has 
successfully come into compliance with the home infusion therapy 
regulations, or whether the AO has failed to do so. Section 
488.1030(d)(4) would provide that if CMS finds that the home infusion 
therapy AO has failed to properly implement the plan of correction and 
come into compliance with the requirements of the home infusion therapy 
AO approval and oversight regulation or the home infusion therapy 
health and safety regulations, CMS may place the home infusion therapy 
AO's on an additional probation period of up to 180 calendar days. If 
this were to occur, the AO would incur the same or similar time and 
cost burdens as in the initial 180 day probationary period. (See 
previous estimates for the estimated time and cost burden associated 
with the 180-day probationary period).
    It is important to note that we have not calculated the burden 
associated with the tasks required of the home infusion therapy AO 
under Sec.  488.1030(d) across all of the potential home infusion 
therapy AOs. We have not done so because the act of CMS placing a home 
infusion therapy AO on an accreditation program review would only occur 
on a sporadic and as needed basis. There is unlikely to ever be a 
situation in which all 8 potential AOs would be under an accreditation 
program review at the same time.
(c) Burden for Home Infusion Therapy AOs Associated With Sec.  488.1035
    Section 488.1035 titled ``Ongoing responsibilities of a CMS-
approved home infusion therapy accrediting organization'' would require 
that the home infusion therapy AO carry out certain activities and 
submit certain documents to CMS on an ongoing basis. Section 
488.1035(a) would require the home infusion therapy AO to submit the 
following documents to CMS: (1) Copies of all home infusion therapy 
accreditation surveys, together with any survey-related information 
that CMS may require (including corrective action plans and summaries 
of findings with respect to unmet CMS requirements); (2) notice of all 
accreditation decisions; (3) notice of all complaints related to 
providers or suppliers; (4) information about all home infusion therapy 
accredited suppliers against which the home infusion therapy 
accreditation organization has taken remedial or adverse action, 
including revocation, withdrawal, or revision of the providers or 
suppliers accreditation; (5) the home infusion therapy accrediting 
organization must provide, on an annual basis, summary data specified 
by CMS that relate to the past year's accreditation activities and 
trends; (6) notice of any changes in the home infusion therapy 
accrediting organization's accreditation standards or requirements or 
survey process.
    We believe that there would be little burden associated with this 
requirements for several reasons. First, while the home infusion 
therapy AOs would be required to provide copies of all survey reports 
and any survey-related information that CMS may require, the AOs would 
only be required to provide this information upon request. CMS may not 
request the home infusion therapy AO to submit this information if 
there are no compliance concerns. Second, we believe the home infusion 
therapy AO would keep these records in the normal course of their 
business as a home infusion therapy AO and would store the survey 
records in electronic format. As the AO already has this information 
prepared and stored in an electronic format, it would place little if 
any burden on the home infusion therapy AO to provide this information 
to CMS. We believe that the AO could send this information to CMS

[[Page 56601]]

via email and attach the survey record electronic files to the email.
    We estimate that it would take approximately 30 minutes to locate 
the required survey information files and approximately 15 minutes for 
the AO staff to prepare an email to CMS and attach the electronic files 
to the email. We believe that the person at the AO that would prepare 
the email sending the survey information to CMS would most likely be a 
clinician such as a registered nurse. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/ooh/healthcare/registered-nurses.htm). Therefore, 
the cost burden to the home infusion therapy AO associated with the 
preparation and submission of the survey reports and information to CMS 
would be $53.04 (30 minutes to locate information requested by CMS x 
$35.36 per hour = $17.68) + (15 minutes x $35.36 = $8.84) + ($26.52 for 
fringe benefits and overhead). The estimated cost across the potential 
8 home infusion therapy AOs for these tasks would be $424.32 ($53.04 x 
8 home infusion therapy AOs = $424.32).
    Section 488.1035(a)(2) would require the home infusion therapy AO 
to provide CMS with notice of all accreditation decisions made for each 
home infusion therapy supplier that files an application for 
accreditation. This would consist of a list of each home infusion 
therapy supplier that had filed an application with the home infusion 
therapy AO for accreditation and the accreditation decision made by the 
AO.
    We believe that these accreditation decisions would be made by the 
AO in the normal course of the AOs business of performing accreditation 
of home infusion therapy suppliers. We further believe that there would 
be little burden associated with the requirement that the AO provide 
CMS with a list of the accreditation decisions made by the AO as this 
is information that would be readily available to the AO and that could 
quickly and easily be provided to CMS via email. We estimate that it 
would take approximately 15 minutes for the home infusion AO to gather 
the required accreditation decision information in preparation for 
sending it to CMS.
    We believe that this information can be sent to CMS via email and 
estimate that it would take an additional 15 minutes for the AO staff 
to prepare an email to CMS and attach the electronic files containing 
the accreditation decision information to the email. We believe that 
the person at the AO who would prepare the accreditation decision 
information and prepare the email to CMS would most likely be a 
clinician such as a registered nurse. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the 
estimated cost burden to the home infusion therapy AO associated with 
the preparation and submission of the survey reports and information to 
CMS would be $35.36 (15 minutes x $35.36 per hour = $8.84) and (15 
minutes x $35.36 = $8.84) + ($17.68 for fringe benefits and overhead). 
The estimated cost across the potential 8 home infusion therapy AOs for 
these tasks would be $282.88 ($35.36 x 8 home infusion therapy AOs = 
$282.88).
    Section 488.1035(a)(3) would require the AO to report complaint 
information to CMS. Complaint information is typically reported to CMS 
by other AOs by email on a monthly basis for the previous month. The 
contents of the complaint information reported to CMS would depend on 
whether the AO had received any complaints during the previous month. 
For example, if the AO received no complaint during the previous month, 
this email could consist of a sentence stating that the AO had received 
no complaints If the AO had received one or more complaints during the 
previous month, the AO would be required to provide information about 
the nature of each complaint, a description of the investigation 
performed, a description of how the complaint was resolved and the date 
resolved.
    We believe that there would be little burden associated with the 
reporting of complaint information by the home infusion therapy AO to 
CMS for several reasons. First, we estimate that the home infusion 
therapy AOs will rarely receive complaints about their accredited home 
infusion therapy suppliers. Second, we believe that the home infusion 
therapy AO will store information about any complaints received in an 
electronic format. Therefore, complaint information can be reported by 
the home infusion therapy AO to CMS via email. We estimate that the 
preparation of the complaint information email would take only no more 
than 15 minutes to prepare and send.
    We believe that the person at the AO who would prepare the 
complaint information email and sent it to CMS would most likely be a 
clinician such as a registered nurse. According to the U.S. Bureau of 
Labor Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the 
estimated monthly cost burden to the home infusion therapy AO 
associated with the submission of complaint information to CMS would be 
$17.68 (15 minutes x $35.36 per hour = $8.84) + ($8.84 for fringe 
benefits and overhead). The estimated yearly burden to the home 
infusion therapy AO for this task would be $212.16 ($17.68 per month x 
12 months per year = $212.16 per year).
    The estimated monthly cost across the potential 8 home infusion 
therapy AOs for these tasks would be $141.44 ($17.68 x 8 home infusion 
therapy AOs = $141.44). The estimated yearly cost across the 6 
potential home infusion therapy AOs would be $1,697.28 ($17.68 x 8 AOs 
= $141.44 per all AOs per month and $141.44 per year x 12 months per 
year = $1,697.28). Section 488.1035(a)(4) would require the AO to 
provide CMS with information about all home infusion therapy accredited 
suppliers against which the home infusion therapy AO has taken remedial 
or adverse action, including revocation, withdrawal, or revision of the 
providers or suppliers accreditation. The information to be sent to CMS 
would simply consist of a list of the home infusion therapy suppliers 
and the type of remedial or adverse action taken.
    We expect that when a home infusion therapy AO takes remedial or 
adverse action against its accredited supplier, the AO would prepare 
documentation which states the action taken and the reason this action 
was taken. We further believe that the AO would store this information 
electronically. This would enable the AO to send the required 
information to CMS via email. Therefore, we believe that there would be 
little burden associated with this requirement.
    We believe that the home infusion therapy AOs could send 
information about adverse or remedial actions they have taken against 
their accredited suppliers via email. We estimate that it would take 
approximately 30 minutes for a home infusion therapy AO to prepare a 
report about the adverse or remedial actions taken against its 
accredited suppliers and approximately 15 minutes to prepare an email 
to CMS, attach the electronic file with the required information and 
send it to CMS. The home infusion therapy AOs would be required to 
report this information to CMS on a monthly basis.
    The AO would incur a cost burden for the wages of the AO staff for 
the time spent preparing the report of the adverse or remedial action 
taken against the AO's accredited home infusion therapy suppliers and 
the time spent preparing

[[Page 56602]]

the email to CMS. We believe that the person at the AO who would 
prepare the report of adverse or remedial action taken and prepare the 
email to CMS would most likely be a clinician such as a registered 
nurse. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost monthly cost 
burden to the home infusion therapy AO associated with the submission 
of information about the adverse or remedial action taken by the home 
infusion therapy AO against its accredited home infusion therapy 
suppliers to CMS would be $53.04 (30 minutes x $35.36 per hour = $17.68 
+ (15 minutes x $35.36 per hour = $8.84) + ($26.52 for fringe benefits 
and overhead). The estimated yearly cost burden to the home infusion 
therapy AO for this task would be $636.48 ($53.04 per month x 12 months 
per year = $636.48 per year).
    The estimated monthly cost across the potential 8 home infusion 
therapy AOs for these tasks would be $424.32 ($53.04 x 8 home infusion 
therapy AOs = $424.32). The estimated yearly cost across the 8 
potential home infusion therapy AOs would be $5,091.84 ($53.04 x 8 AOs 
= $424.32 per all AOs per month and $424.32 per year x 12 months per 
year = $5,091.84).
    Section 488.1035(a)(5) would require the home infusion therapy 
accrediting organization to provide, on an annual basis, summary data 
specified by CMS that relates to the past year's accreditation 
activities and trends. This summary data might include information such 
as the total number of complaints received during the year, the total 
number of immediate jeopardy situations found during the year, and the 
total number of deficiencies cited. We believe this is information that 
the AO would collect and document throughout the year in the normal 
course of business. We further believe that the home infusion therapy 
AO would prepare this year end summary data for their own 
informational, quality improvement, and research purposes.
    We believe that there would be little, if any time burden 
associated with the submission of the documents and information 
required by Sec.  488.1035(a)(5) by the home infusion therapy AOs to 
CMS, because these are documents which the AO would keep in the normal 
course of business, therefore these documents would be easily 
accessible to the home infusion therapy AO. Title 5 CFR 1320.3(b)(2) 
states that the time, effort, and financial resources necessary to 
comply with a collection of information that would be incurred in the 
normal course of their activities (for example in compiling and 
maintaining business records) will be excluded from the burden if the 
agency demonstrates that the reporting, recordkeeping, or disclosure 
activities needed to comply are usual and customary. Further, we 
believe that most, if not all of the home infusion therapy AOs would 
store these documents electronically and would be able to send them 
electronically to CMS via email.
    The home infusion therapy AO would incur a time burden for the 
preparation and submission of the annual summary data to CMS. We 
estimate that it would take approximately 60 minutes for the home 
infusion therapy AO to locate the required annual summary data 
information and prepare it for submission to CMS. We further estimate 
that it would take an additional 15 minutes to prepare an email to CMS 
and attach the electronic files containing the summary data.
    The home infusion therapy AO would incur a cost burden for the 
wages of the AO staff who prepares that summary data for submission to 
CMS and prepares the email to in which the annual summary data are 
submitted to CMS. We believe that the person at the AO who would 
prepare the summary data for submission to CMS and also prepare the 
email to CMS would most likely be a clinician such as a registered 
nurse. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the 
home infusion therapy AO associated with the submission of summary data 
to CMS would be $88.40 (60 minutes x $35.36 per hour = $35.36) + (15 
minutes x $35.36 per hour = $8.84) + ($44.20 for fringe benefits and 
overhead). The estimate cost burden across the 8 potential home 
infusion therapy AOs for this task would be $707.20 ($88.40 x 8 
potential home infusion therapy AOs = $707.20).
    Section 488.1035(b) would require that within 30 calendar days 
after a change in CMS requirements, the home infusion therapy 
accrediting organization must submit an acknowledgment of receipt of 
CMS' notification to CMS. The time burden associated with this 
requirement would be the time required for an AO staff person to review 
the notification from CMS about the change in home infusion therapy 
accreditation program requirements and the time required for the AO 
staff person to compose and send an acknowledgement email to CMS.
    We estimate the time required for the AO staff to review the notice 
of a change in CMS requirements would be 1 hour. We further estimate 
that the time that would be required to prepare and submit the 
acknowledgement of receipt of the CMS notice would be approximately 15 
minutes because this notice could be sent to CMS via email and would 
only consist of 1-2 paragraphs.
    The home infusion therapy AO would incur a cost burden for the 
wages of the staff for the time required to review the notice from CMS 
of the change in CMS requirements. The home infusion therapy AO would 
incur a cost burden for the wages of the staff for the time required to 
prepare the acknowledgement and submits it to CMS. We believe that the 
person at the AO who would prepare the email to CMS acknowledging 
receipt of the CMS notice would most likely be a clinician such as a 
registered nurse. According to the U.S. Bureau of Labor Statistics, the 
mean hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm).
    The estimated cost burden to the home infusion therapy AO 
associated with the review of the notice from CMS of changes to the CMS 
requirements would be $70.72 (1 hour x $35.36 per hour) + ($35.36 for 
fringe benefits and overhead). The estimated cost burden associated 
with the preparation and submission of the acknowledgement by the home 
infusion therapy AO would be $17.68 (15 minutes x $35.36 per hour = 
$8.84) + ($8.84 for fringe benefits and overhead). The estimates cost 
across the 8 potential home infusion therapy AOs would be $707.20 
($70.72 x 8 = $565.76) + ($17.68 x 8 = $141.44).
    It is important to note that the home infusion therapy AOs would 
only have to perform these tasks if CMS were to make a change to the 
home infusion therapy standards. We believe that this would occur on an 
infrequent basis, therefore, the home infusion therapy AOs would incur 
these time and cost burdens on an infrequent basis.
    Section 488.1035(c) would require that the home infusion therapy AO 
permit its surveyors to serve as witnesses if CMS takes an adverse 
action based on accreditation findings. An example in which a surveyor 
would be needed to testify as a witness would be if there was 
litigation about CMS' termination of a home infusion therapy supplier's 
participation in the Medicare program and the surveyor that had 
performed a survey of that home infusion therapy supplier was needed to

[[Page 56603]]

testify about the survey findings. The burden associated with this 
requirement would be the time the surveyor spent providing testimony, 
any travel expenses the home infusion therapy AO would be responsible 
to pay, and the wages paid to the surveyor during the time spent giving 
testimony.
    The home infusion therapy AO would incur a time burden for the time 
required for the AO's surveyor to serve as a witness. This would 
include travel time to and from the location where the hearing is being 
held. The AO would also incur cost burdens for the wages paid to the 
surveyor during the time they are serving as a witness and also for any 
travel expenses the AO may be required to pay, that are not reimbursed.
    It is important to note that the home infusion therapy AO surveyors 
would rarely, if ever, be required to act as a witness. Therefore, this 
is a burden that the home infusion therapy AOs would not be likely to 
incur.
    Section 488.1035(d) would require that, within 2 business days of 
identifying a deficiency of an accredited home infusion therapy 
supplier that poses immediate jeopardy to a beneficiary or to the 
general public, the home infusion therapy AO must provide CMS with 
written notice of the deficiency and any adverse action implemented by 
the AO. The burden associated with this requirement is the time 
required to provide notice to CMS of the immediate jeopardy situation 
and the wages for the AO staff person for the time spent preparing and 
submitting this notice.
    We believe that the AO would keep this information in the normal 
course of their business of providing home infusion therapy 
accreditation. Therefore, the AO should have these readily available. 
We further believe that the home infusion therapy AOs would keep 
records related to immediate jeopardy findings in an electronic format.
    The AO would incur a time burden for the time required to report 
the immediate jeopardy information to CMS. We estimate that it would 
take the AO no more than 20 minutes to prepare an email to CMS in which 
they provide the required information about the immediate jeopardy 
situation that has been discovered. The AO can attach electronic files 
to the email that contain the required information. It is important to 
note that we do not count, as a burden, the time spent by the home 
infusion therapy AO in finding the immediate jeopardy situation or 
resolving it, because it is the duty of any CMS-approved AO to monitor 
it's accredited providers or supplier to ensure they are providing care 
that meets the accreditation standards and that they do not have any 
situation that put the patients or general public in imminent danger of 
harm. The home infusion therapy AO would incur a cost burden for the 
wages of the AO staff that prepares the email to CMS which notified CMS 
of the immediate jeopardy situation. We believe that the person at the 
AO who would prepare the immediate jeopardy notification email to CMS 
would most likely be a clinician such as a registered nurse. According 
to the U.S. Bureau of Labor Statistics, the mean hourly wage for a 
registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the home 
infusion therapy AO associated with the preparation and submission of 
the acknowledgement by the home infusion therapy AO would be $23.60 
($35.36 divided by 60 minutes per hour = $0.59 per minute/20 minutes x 
$0.59 per minute = $11.80) + ($11.80 for fringe benefits and overhead).
    The home infusion therapy AOs would have to perform these tasks and 
incur these time and costs burdens only if they discover an immediate 
jeopardy situation with an accredited home infusion therapy supplier. 
We would like to point out that this would not be a regular time and 
cost burden that would be incurred by the home infusion therapy AOs, as 
the discovery of immediate jeopardy situations by AOs do not occur 
frequently.
    It is important to note that we have not calculated the burden 
associated with the tasks required of the home infusion therapy AO 
under Sec.  488.1035(d) across all of the potential home infusion 
therapy AOs. We have not done so because the need for a home infusion 
therapy AO to report an immediate jeopardy situation to CMS would only 
occur on a sporadic basis. Section 488.1035(e) would require that 
within 10 calendar days after CMS' notice to a CMS-approved home 
infusion therapy AO that CMS intends to withdraw approval of the AO's 
home infusion therapy accreditation program, the home infusion therapy 
AO must provide written notice of the withdrawal to all of the home 
infusion therapy AO's accredited suppliers. The time burden associated 
with this requirement would be the time spent by the AO staff to 
prepare the required notice that must be sent to all of the AOs 
accredited home infusion therapy suppliers and the time required for 
the AO to send this notice out to all of its accredited suppliers.
    We estimate that it would take that home infusion therapy AO 
approximately 45 minutes to prepare the notice that they must send out 
to their accredited suppliers. We believe it would take an additional 2 
minutes per letter to be sent by the home infusion therapy AO to its 
accredited suppliers to prepare these letters for mailing (that is--
fold letter, place in envelope, affix correct amount of postage and 
place the letter into the outgoing mail). We are not able to accurately 
estimate the amount of time it would take for the AO to send this 
notice out to all of its accredited suppliers because this would be 
dependent on the number of accredited suppliers the AO has at the time. 
However, if were to assume that a home infusion therapy AO had 50 
accredited home infusion therapy suppliers, this task would take the AO 
staff 1.7 hours to complete (2 minutes x 50 letters = 100 minutes) and 
(100 minutes divided by 60 minutes per hour = 1.7 hours).
    The home infusion therapy AO would incur a cost burden for the 
wages of the AO staff person that prepares the required notification. 
We believe that the person at the AO who would prepare the required 
notification would most likely be a clinician such as a registered 
nurse. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the 
home infusion therapy AO associated with the preparation of the 
required notice which is to be sent to all of the AO's accredited 
suppliers would be $53.04 (45 minutes x $35.36 per hour = $26.52) + 
($26.52 for fringe benefits and overhead).
    The home infusion therapy would also incur a cost burden for the 
wages of the staff person for the time spent preparing the required 
notices for mailing and mailing them. We are unable to accurately 
estimate this cost burden because the time required to perform this 
task would be dependent on the number of accredited home infusion 
therapy supplier the AO has at the time. However, if were to assume 
that a home infusion therapy AO had 50 accredited home infusion therapy 
suppliers, this task would take the AO staff 1.7 hours to complete (2 
minutes x 50 letters = 100 minutes/100 minutes divided by 60 minutes 
per hour = 1.7 hours). We believe that the person that would perform 
this task would be an Administrative Assistant. According to the U.S. 
Bureau of Labor Statistics, the mean hourly wage for an executive 
administrative Assistant is $28.56 (https://www.bls.gov/oes/current/oes436011.htm). Therefore, the home infusion therapy AO would incur a 
cost burden in the amount of $97.92 for the

[[Page 56604]]

completion of this task ($28.56 per hour divided by 60 minutes per hour 
= $0.48 per minute/60 minutes per hour divided by 10 = 6 minutes per 
0.1 hour/6 minutes x 7 = 42 minutes = 0.7 hour/60 minutes + 42 minutes 
= 102 minutes or 1.7 hours/$0.48 per minute x 102 minutes = $48.96) + 
($48.96 for fringe benefits and overhead).The home infusion therapy AO 
would incur an additional cost burden for miscellaneous costs. These 
costs would include the cost of the paper used to print the notices on, 
the printer ink used, the cost of the envelopes used, and the postage 
required to mail all the notices. We are unable to accurately estimate 
these costs as they are dependent on the number of notices that would 
be sent. We believe that these costs would not exceed $250.
    It is important to note that the home infusion therapy AO surveyors 
would rarely, if ever, be required to perform the tasks required by 
Sec.  488.1035(e) because we would rarely withdraw the CMS approval of 
a home infusion therapy AO. We would do so if there were serious, 
unresolved compliance concerns that the AO was unable or unwilling to 
rectify, even after being placed on an accreditation program 
probationary period.
(d) Burden for Home Infusion Therapy AOs Related to Sec.  488.1040
    Section 488.1040 would require that as part of the application 
review process, the ongoing review process, or the continuing oversight 
of an home infusion therapy AO's performance, CMS may conduct onsite 
inspections of the home infusion therapy AO's operations and offices at 
any time to verify the home infusion therapy AO's representations and 
to assess the home infusion therapy AO's compliance with its own 
policies and procedures. Section 488.1040(b) provides that the 
activities to be performed by CMS staff during the onsite inspections 
may include, but are not limited to the following: (1) Interviews with 
various AO staff; (2) review of documents, survey files, audit tools, 
and related records; (3) observation of meetings concerning the home 
infusion therapy accreditation process; (4) auditing meetings 
concerning the accreditation process; (5) observation of in-progress 
surveys and audits; and (6) evaluation of the AO's survey results and 
accreditation decision-making process.
    We believe that there would be little burden associated with the 
onsite visits made by CMS to the home infusion therapy AO's operations 
and offices because most of the activities related to the onsite visit 
involve work performed by the CMS staff, which would not impose burden 
on the AO staff (such as review of records or observation of meeting 
held at the AOs offices). We estimate that the time burden to the home 
infusion therapy AO associated with these onsite visits would include 
the time required for the AO staff to greet the CMS team upon arrival 
and show them to the conference room, the time required to locate the 
records the CMS team requests for review, and the time required for CMS 
to conduct interviews of AO staff members. If the home infusion therapy 
AOs records are electronic, an AO staff member may need to remain with 
the CMS team during their record review to assist them with access to 
the AO's records.
    We are not able to accurately estimate the total time that would be 
required for these activities because we have not yet accredited any 
home infusion therapy AOs, nor have we had an opportunity to perform an 
onsite visit to a home infusion therapy AO. We do not yet know what 
type of accreditation standards and surveys processes the home infusion 
therapy AOs would use. Also, we do not know the amount and type of 
records we would seek to review during an onsite visit to a home 
infusion therapy AO or approximately how much time we would need to 
review these records. Likewise, we do not yet know how much interaction 
we would need to have with the home infusion therapy AO staff or which 
AO staff members we would choose to interview. The onsite AO visits we 
have performed for other types of AOs have lasted 1 to 2 days depending 
on the type of AO.
    However, if we estimate that it would take 1 hour for the CMS team 
entrance conference, 8 hours for the CMS team to perform their records 
review and 1 hour for the CMS team conduct the exit conference, the 
home infusion therapy AO would incur a time burden in the amount of 1 
hour for each AO staff person that attends the entrance conference, 8 
hours for any staff that remains with the CMS team to assist them with 
the record review and 1 hour of time for each AO staff person that 
attends the exit conference. We believe that the AO staff that would be 
attending the entrance and exit conferences and assisting the CMS staff 
with their records review would most likely be clinicians such as 
registered nurses. According to the U.S. Bureau of Labor Statistics, 
the mean hourly wage for a non-industry specific registered nurse is 
$35.36 (https://www.bls.gov/oes/current/oes291141.htm). We estimate 
that approximately 4 AO staff persons would attend the entrance and 
exit conferences and that one AO staff person would assist the CMS team 
with their record review.
    Based on the a previously stated time estimate, we estimate that 
the home infusion therapy AO would incur a cost burden in the amount of 
$282.88 for wages for four AO staff for attendance at the entrance 
conference. ($35.36 per hour per each AO staff x 1 hour = $35.36/$35.36 
per hour x 4 AO staff = $141.44) + ($141.44 for fringe benefits and 
overhead).
    We further estimate that the AO would incur a cost burden in the 
amount of $282.88 for the wages of the four AO staff for attendance at 
the exit conference. ($35.36 per hour per each AO staff x 1 hour = 
$35.36/$35.36 per hour x 4 AO staff = $141.44) + ($141.44 for fringe 
benefits and overhead).
    We also estimate that the AO would incur a cost burden in the 
amount of $565.76 for the wages of the AO staff person that would 
remain with the CMS team to assist them with their record review. (8 
hours x $35.36 = $282.88) + ($282.88 for fringe benefits and overhead).
    The total estimated cost burden to the home infusion therapy AO 
associated with the CMS onsite visit is $1,131.52 ($282.88 for entrance 
conference + $282.88 for exit conference + $565.76 for assisting CMS 
staff with record review = $1,131.52). The estimated cost burden across 
all of the potential eight home infusion therapy AOs would be $9,052.16 
($1,131.52 x 8 potential AOs = $9,052.16).
    In this final rule with comment period, we have the eight AOs that 
currently provide accreditation to home infusion therapy suppliers must 
submit an application to CMS for approval of a separate and distinct 
home infusion therapy accreditation program. A corporate onsite visit 
to the home infusion therapy AOs office is a part of the application 
review and approval process. Therefore, each of the AOs that submit an 
application to CMS for approval of a home infusion therapy program 
would incur the previously stated estimated burden related to the 
corporate onsite visit. However, after the initial application process 
has been completed, CMS would only make additional corporate onsite 
visits every 6 years when the home infusion therapy AOs submit their 
renewal application. Therefore, this would not be is a frequent or 
ongoing burden incurred by the home infusion therapy AOs.
(e) Burden for Home Infusion Therapy AOs Related to Sec.  488.1045
    Section Sec.  488.1045 contains regulations related to the 
voluntary and involuntary termination of the CMS

[[Page 56605]]

approval of a home infusion therapy AO's home infusion therapy 
accreditation program. Section 488.1045(a) would provide that a home 
infusion therapy accrediting organization that decides to voluntarily 
terminate its CMS-approved home infusion therapy accreditation program 
must provide written notice at least 90 days in advance of the 
effective date of the termination to CMS and each of its accredited 
home infusion therapy suppliers.
    The requirement that the home infusion therapy AO provide notice of 
its decision to voluntarily terminate its CMS approved home infusion 
therapy accreditation program to CMS and all of its accredited home 
infusion therapy suppliers would cause the AO to incur the following 
time burdens: (1) The time required to prepare and send the required 
notice to CMS; and (2) the time required to prepare and send the 
required notice to all of the AOs accredited home infusion therapy 
suppliers. We would require that the AO send the required notice of 
their decision to voluntarily terminate its CMS-approved accreditation 
program to CMS by U.S. mail. We would also require the AO to send the 
required notice to all of its accredited home infusion therapy 
suppliers by U.S. mail. We estimate that it would take approximately 60 
minutes for the AO staff person to prepare the letter to CMS in which 
the AO notified CMS that the AO wishes to voluntarily terminate its 
CMS-approved home infusion therapy accreditation program, print the 
letter and mail it.
    We further estimate that it would take the AO staff person another 
4 hours to perform the following tasks: (1) Draft a letter its 
accredited home infusion therapy suppliers, giving notice that the AO 
is voluntarily terminating its CMS approved home infusion therapy 
accreditation program; (2) perform a mail merge to prepare a copy of 
the letter addressed to each accredited home infusion therapy supplier; 
(3) print out a letter to each accredited supplier and envelope; put 
the letters into the envelopes; (4) affix the correct amount of 
postage; and (5) put the envelopes in the outgoing mail. We believe 
that the person at the AO who would perform these tasks would most 
likely be a clinician such as a registered nurse. According to the U.S. 
Bureau of Labor Statistics, the mean hourly wage for a registered nurse 
is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, 
the estimated cost burden to the home infusion therapy AO associated 
with the preparation of the required notice which is to be sent to all 
of the AO's accredited suppliers would be $35.36 (60 minutes x $35.36 
per hour = $35.36).
    The home infusion therapy AO would also incur a cost burden for the 
wages of the staff person for the time spent preparing and mailing the 
required notices to be sent to the AO's accredited home infusion 
therapy suppliers. As stated previously, we estimate that it would take 
approximately 4 hours of time for an AO staff person to prepare the 
required notification letter to the AOs accredited providers, print out 
a copy of the letter for each accredited home infusion therapy supplier 
and put these letters into the mail. We believe that the person at the 
AO who would perform these tasks would most likely be a clinician such 
as a registered nurse. According to the U.S. Bureau of Labor 
Statistics, the mean hourly wage for a registered nurse is $35.36 
(https://www.bls.gov/oes/current/oes291141.htm). Therefore, the 
estimated cost burden to the home infusion therapy AO associated with 
the preparation of the required notice for mailing would be $353.60 (4 
hours x $35.36 per hour = $176.80) + ($176.80 for fringe benefits and 
overhead).
    The home infusion therapy AO would incur an additional burden for 
miscellaneous costs associated with the preparation of the required 
notices to be sent to CMS and the AOs accredited home infusion therapy 
suppliers, including the cost of the paper on which the notices are 
printed, the printer ink used, the cost of the envelopes used, and the 
postage required to mail all of the notices. We are unable to 
accurately estimate these costs as they are dependent on the number of 
notices that would need to be sent. However we believe these costs 
would not exceed $200. We seek comment on how to estimate this burden.
    It is important to note that we have not calculated the burden 
associated with the tasks required of the home infusion therapy AO 
under Sec.  488.1045 across all of the potential home infusion therapy 
AOs. We have not done so because the need for a home infusion therapy 
AO to perform these tasks only arise if a home infusion therapy AO 
voluntarily decides to terminate its CMS approved home infusion therapy 
accreditation program. This would occur rarely, if ever.
    Section 488.1045(b) states that once CMS publishes a notice in the 
Federal Register announcing the decision to involuntarily terminate the 
home infusion therapy AO's home infusion therapy accreditation program, 
the home infusion therapy AO must provide written notification to all 
suppliers accredited under its CMS-approved home infusion therapy 
accreditation program by no later than 30 calendar days after the 
notice is published in the Federal Register. This notice would announce 
that CMS is withdrawing its approval of the AOs home infusion therapy 
accreditation program and the implications for the home infusion 
therapy suppliers payment status in accordance with the requirements at 
Sec.  488.1010(f) once their current term of accreditation expires.
    The time burden associated with Sec.  488.1045(b) would be the time 
it takes for the home infusion therapy AO to prepare and send the 
required written notification to all accredited home infusion therapy 
suppliers which states that CMS is withdrawing the AOs approval of the 
home infusion therapy accreditation program and which also states the 
implications for the home infusion therapy suppliers payment status. We 
estimate that it would take no more than 4 hours for an AO staff person 
to perform the following tasks: (1) Draft the required notification 
letter; (2) perform a mail merge to prepare a copy of the letter that 
is addressed to each home infusion therapy supplier accredited by the 
AO; (3) print copies of the notification letters for each of the AOs 
accredited home infusion therapy suppliers; (4) put each notifications 
letter into an envelope; (5) affix the correct amount of postage to the 
envelope and (6) put the envelopes into the outgoing mail.
    The home infusion therapy AO would incur a cost burden for the 
wages for the AO staff who performs the previously stated tasks. We 
believe that the person at the AO who would perform these tasks would 
most likely be a clinician such as a registered nurse. According to the 
U.S. Bureau of Labor Statistics, the mean hourly wage for a registered 
nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). 
Therefore, the estimated cost burden to the home infusion therapy AO 
associated with the preparation of the required notice which is to be 
sent to all of the AO's accredited suppliers would be $282.88 (4 hours 
x $35.36 per hour = $141.44) + ($141.44 for fringe benefits and 
overhead).
    The home infusion therapy AO would incur an additional burden for 
miscellaneous costs associated with the preparation of the required 
notices to be sent to the AOs accredited home infusion therapy 
suppliers, including the cost of the paper on which the notices are 
printed, the printer ink used, the cost of the envelopes used, and the 
postage required to mail all of the notices. We believe that these 
costs would not exceed $200.

[[Page 56606]]

    It is important to note that we have not calculated the burden 
associated with the tasks required of the home infusion therapy AO 
under Sec.  488.1045 across all of the potential home infusion therapy 
AOs. We have not done so because the need for a home infusion therapy 
AO to perform these tasks required by Sec.  488.1045(b) would only 
arise if CMS decides to involuntarily terminate the CMS approval of the 
AO's home infusion therapy accreditation program. This would occur 
rarely, if ever.
    Section 488.1045(c)(3) would require that for both voluntary and 
involuntary terminations of a home infusion therapy AOs CMS approved 
home infusion therapy accreditation program, the home infusion therapy 
AO must provide a second written notification to all of its accredited 
home infusion therapy suppliers ten calendar days prior to the AO's 
accreditation program termination effective date. We estimate that the 
time and cost burdens associated with this requirement would be the 
same as our estimated burden for proposed Sec.  488.1045(b) set forth 
previously.
    Section 488.1045(d) sets forth the required steps that a home 
infusion therapy AO must take when one of its accredited home infusion 
therapy suppliers has requested a voluntary withdrawal from 
accreditation. The withdrawal from accreditation by the home infusion 
therapy supplier may not become effective until the AO completes all of 
the following 3 steps: (1) The home infusion therapy AO must contact 
the home infusion therapy supplier to seek written confirmation that 
the home infusion therapy supplier intends to voluntarily withdraw from 
the home infusion therapy accreditation program; (2) the home infusion 
therapy AO must advise the home infusion therapy supplier, in writing, 
of the statutory requirement for accreditation for all home infusion 
therapy suppliers and the possible payment consequences for a lapse in 
accreditation status; (3) the home infusion therapy AO must submit 
their final notice of the voluntary withdrawal of accreditation by the 
home infusion therapy supplier to CMS by no later than 5 business days 
after the request for voluntary withdrawal is ultimately processed and 
effective.
    The burden associated with the requirement that the home infusion 
therapy AO contact the home infusion therapy supplier to seek written 
confirmation that the home infusion therapy supplier intends to 
voluntarily withdraw from the home infusion therapy accreditation 
program would include the time required for the AO to contact the home 
infusion therapy supplier to request written confirmation that the home 
infusion therapy supplier does indeed want to terminate their home 
infusion therapy accreditation. We estimate that the AO would most 
likely contact the home infusion therapy supplier to make this request 
by telephone or email. We estimate this would take no more than 15 
minutes.
    The AO would incur a cost burden for the wages of the AO staff 
person for the time spent contacting the home infusion therapy supplier 
to confirm they intend to voluntarily withdraw from the home infusion 
therapy accreditation program. We believe that the person at the AO who 
would perform this task would most likely be a clinician such as a 
registered nurse. According to the U.S. Bureau of Labor Statistics, the 
mean hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the 
home infusion therapy AO associated with contacting the home infusion 
therapy supplier to confirm that they do want to voluntarily terminate 
would be $17.68 (15 minutes x $35.36 per hour = $8.84) + ($8.84 for 
fringe benefits and overhead).
    The home infusion therapy AO would also incur a time burden 
associated with the requirement that they send a written notice to the 
home infusion therapy supplier that is voluntarily terminating their 
home infusion therapy accreditation, which provides notice of the 
statutory requirement for accreditation for all home infusion therapy 
suppliers and the possible payment consequences for a lapse in 
accreditation status. We estimate that it would take the home infusion 
therapy no more than 60 minutes to prepare the written notification.
    We believe that the person at the AO who would prepare the required 
written notice to be sent to the home infusion therapy supplier that is 
voluntarily terminating its home infusion therapy accreditation would 
most likely be a clinician such as a registered nurse. According to the 
U.S. Bureau of Labor Statistics, the mean hourly wage for a registered 
nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). 
Therefore, the estimated cost burden to the home infusion therapy AO 
associated with the preparation of the required written notice would be 
$70.72 (1 hours x $35.36 per hour = $35.36) + ($35.36 for fringe 
benefits and overhead). We further estimate that the AO would incur 
postage costs in the amount of $0.50 for each letter sent.
    Finally, we estimate the burden associated with Sec.  
488.1045(d)(3) would include the time required for the home infusion 
therapy AO staff to prepare a final notice of voluntary withdrawal of 
accreditation by the home infusion therapy supplier and the time 
required to send this notice to CMS. We estimate that it would only 
take the AO staff 15 minutes or less to prepare the required notice for 
CMS, because this notice could be sent to CMS by email. We estimate it 
would take an additional 10 minutes of time for the AO staff to prepare 
the email and attach the written notice to the email.
    The AO would incur a cost burden for the wages of the AO staff for 
the time spent preparing the notice and sending it to CMS. We believe 
that the person at the AO who would prepare the required written notice 
to be sent to CMS would most likely be a clinician such as a registered 
nurse. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the 
home infusion therapy AO associated with the preparation of the 
required written notice to be sent to CMS would be $29.48 (15 minutes x 
$35.36 per hour = $8.84) + (10 minutes x $35.36 per hour = $5.90) + 
($14.74 for fringe benefits and overhead).
    It is important to note that we have not calculated the burden 
associated with the tasks required of the home infusion therapy AO 
under Sec.  488.1045(d) across all of the potential home infusion 
therapy AOs. We have not done so because the need for a home infusion 
therapy AO to perform these tasks would only arise if a home infusion 
therapy supplier would decide to voluntarily terminate its 
accreditation with the home infusion therapy AO. This would occur on an 
infrequent basis. We do not believe that there would ever be a 
situation in which all 6 of the potential home infusion therapy AOs 
would have a home infusion therapy supplier decide to voluntarily 
terminate the accreditation with their home infusion therapy AOs 
simultaneously.
(f) Burden for Home Infusion Therapy AOs Associated With Sec.  488.1050
    Section 488.1050(a) would provide that a home infusion therapy AO 
that is dissatisfied with a determination, made by CMS, that its home 
infusion therapy accreditation requirements do not provide or do not 
continue to provide reasonable assurance that the suppliers accredited 
by the home infusion therapy AO meet the applicable quality standards 
is entitled to reconsideration.

[[Page 56607]]

    Section 488.1050(b)(1) would require that a written request for 
reconsideration be filed within 30 calendar days of the receipt of CMS' 
notice of an adverse determination or non-renewal. Section 
488.1050(b)(2) would provide that the written request for 
reconsideration must specify the findings or issues with which the home 
infusion therapy AO disagrees and the reasons for the disagreement. 
Section 488.1050(c)(1) provides the opportunity for a hearing to be 
conducted by a hearing officer appointed by the Administrator of CMS 
and Sec.  488.1050(c)(2) provides that written notice of the time and 
place of the hearing will be provided at least 10 business days before 
the scheduled date.
    We estimate that it would take approximately 2 hours for a home 
infusion therapy AO to prepare its request for reconsideration. We 
believe that the person at the AO who would prepare the request for 
reconsideration would most likely be a clinician such as a registered 
nurse. According to the U.S. Bureau of Labor Statistics, the mean 
hourly wage for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the 
home infusion therapy AO associated with the preparation of the request 
for reconsideration would be $141.44 (2 hours x $35.36 per hour = 
$70.72) + ($70.72 for fringe benefits and overhead).
    The remaining information that would be submitted in connection 
with a request for reconsideration or a reconsideration hearing, 
including any evidence or testimony provided is not considered 
``information'' in accordance with 5 CFR 1320.3(h)(8), which excludes 
as ``information'' any ``facts or opinions obtained or solicited at or 
in connection with public hearings.''
    It is important to note that we have not calculated the burden 
associated with the tasks required of the home infusion therapy AO 
under Sec.  488.1050 across all of the potential home infusion therapy 
AOs. We have not done so because we believe that the filing of a 
request for reconsideration by a home infusion therapy AO would occur 
rarely, if ever. Further, we do not believe that there would ever be a 
situation in which all 6 of the potential home infusion therapy AOs 
would decide to file a request for reconsideration at the same time. 
Therefore, there would never be an occurrence where all the home 
infusion therapy AOs would incur the previously stated burden 
simultaneously.
(g) Burdens for Home Infusion Therapy AOs Related to Survey Activities 
and Accreditation of Home Infusion Therapy Suppliers
    The home infusion therapy AO would incur time and cost associated 
the accreditation of home infusion therapy suppliers. These would 
include the time and costs required to perform an onsite survey, 
offsite survey or other type of survey activity for each home infusion 
therapy supplier that has hired that AO to provide accreditation. 
However, as we have not approved any home infusion therapy AOs, we do 
not yet know what type of home infusion therapy accreditation standards 
they will use, or what the home infusion therapy accreditation survey 
process will consist of. Therefore, we are unable to accurately 
estimate the time and cost burden associated with the survey of home 
infusion therapy suppliers.
    However, we can state that if the home infusion therapy AO were to 
perform an onsite survey, it would incur wages for each of the 
surveyors that are sent to perform the survey for the amount of time 
spent performing the survey. The AO would also incur wages for the time 
spent by the surveyors or other home infusion therapy AO staff in 
reviewing the survey documents, making a decision about whether to 
grant accreditation to the home infusion therapy supplier that was 
surveyed and preparing the decision letter to the home infusion therapy 
supplier. The AO would also incur travel costs for the AO staff to 
travel to the home infusion therapy supplier's location to perform the 
survey.
    If the home infusion therapy AO were to do an offsite records audit 
survey, the AO would request that the home infusion therapy supply the 
AO with specific records. The AO would incur costs for the wages of the 
AO staff that performed the audit of the documents provided by the home 
infusion therapy supplier. The AO would also incur wages for the time 
spent by the surveyors or other home infusion therapy AO staff in 
making a decision about whether to grant accreditation to the home 
infusion therapy supplier that was audited and preparing the decision 
letter to the home infusion therapy supplier.
    We solicited comment on how to estimate this burden and receive 
none.
2. Burden to Home Infusion Therapy Suppliers Related to Home Infusion 
Therapy Health and Safety Standards
    All existing home infusion therapy suppliers are already accredited 
by existing home infusion therapy AOs to meet requirements established 
by private insurers and Medicare Advantage plans. We that, in order for 
the existing home infusion therapy suppliers accredited by these AOs to 
continue to receive payment for the home infusion therapy services 
provided, these AOs must obtain Medicare approval for a home infusion 
therapy accreditation program. To obtain this CMS approval, we that 
these AOs would be required to submit an application to CMS seeking 
approval of a home infusion therapy accreditation program that meets 
the requirements set forth in the new home infusion therapy AO approval 
and oversight regulations and new home infusion therapy health and 
safety regulations. We would also require that the home infusion 
therapy program submitted by these AOs be separate and distinct from 
the AOs home health deeming accreditation program.
    It is likely that the home infusion therapy suppliers would need to 
be resurveyed after their home infusion therapy AO obtains CMS approval 
of a home infusion therapy accreditation program, under section 
1861(iii)(3)(D)(i)(III) of the Act. We believe this resurvey would be 
necessary because the AOs would have to determine if the home infusion 
therapy suppliers they accredit meet their new Medicare-approved home 
infusion therapy accreditation program accreditation standards. 
However, if a current home infusion therapy AOs current home infusion 
therapy standards already meet or exceed the home infusion therapy 
health and safety standards, so that a revision of that AOs home 
infusion therapy accreditation standards is not required, then a 
resurvey of that AO's accredited home infusion therapy suppliers may 
not be necessary.
    The home infusion therapy supplier would incur some time burden in 
order to come into compliance with the home infusion therapy AOs new 
home infusion therapy accreditation program requirements initially and 
thus prepare for the accreditation survey. However, all existing home 
infusion therapy suppliers are already accredited by existing home 
infusion therapy AOs to meet requirements established by private 
insurers and Medicare Advantage plans. Therefore, we assume that there 
would be little, is any new burden imposed on home infusion therapy 
suppliers in order to implement the new health and safety standards.
    The home infusion therapy supplier would be charged a fee by the AO 
for providing accreditation services. Fees for the home infusion 
therapy

[[Page 56608]]

accreditation currently offered by the six AOs listed previously 
accreditation programs offered by the six AOs listed previously vary 
between $5,950 and $12,500 and, in general, currently cover all of the 
following items: Application fee, manuals, initial accreditation fee, 
onsite surveys or other auditing (generally once every 3 years), and 
travel, when necessary for survey personnel. Accreditation costs also 
vary by the size of the provider or supplier seeking accreditation, its 
number of locations, and the number of services it provides.
    We recognize that cost and time burdens associated with becoming 
accredited may be a barrier for small suppliers such as home infusion 
therapy suppliers. We are implementing the following to minimize the 
burden of accreditation on suppliers, including small businesses:
     Multiple accreditation organizations--We expect that more 
than one AO would submit an application to become a designated Home 
Infusion Therapy AO. We believe that selection of more than one home 
infusion therapy AO would introduce competition resulting in reductions 
in accreditation costs.
     Required plan for small businesses--During the application 
process we would require prospective home infusion therapy AOs to 
include a plan that details their methodology to reduce accreditation 
fees and burden for small or specialty suppliers. This would need to 
include that the AO's fees are based on the size of the organization.
     Reasonable quality standards--The quality standards that 
would be used to evaluate the services rendered by each home infusion 
therapy supplier are being in this rule. Many home infusion therapy 
suppliers already comply with the standards and have incorporated these 
practices into their daily operations. It is our belief that compliance 
with the quality standards would result in more efficient and effective 
business practices and would assist suppliers in reducing overall 
costs.
    There are at least two important sources of uncertainty in 
estimating the impact of accreditation on home infusion therapy 
suppliers. First, our estimates assume that all home infusion therapy 
suppliers with positive Medicare payments would seek accreditation. We 
assume that home infusion therapy suppliers who currently receive no 
Medicare allowed charges would choose not to seek accreditation. It is 
also possible that many of the home infusion therapy suppliers with 
allowed charges between $1 and $1,000 may decide not to incur the costs 
of accreditation.
    Second, it is difficult to predict what accreditation fees would be 
in the future. Our experience with other accreditation programs has 
lead us to believe that the accreditation rates would go up, due to 
factors such as wage increases, and increased travel costs. To monitor 
accreditation fees, we proposed to require the AOs for home infusion 
therapy suppliers to submit their fees to CMS for review for 
reasonableness. We would require home infusion therapy AOs to notify 
CMS anytime there is an increase in accreditation fees.
(d) Medicare-Certified Accreditation Organizations--Proposed Changes to 
42 CFR 488.5
    We proposed to modify the AO approval and oversight regulations for 
Medicare-certified providers and suppliers by adding two new 
requirements. The first new requirement would have been to add to 42 
CFR 488.5(a)(7) a requirement that in their application for CMS 
approval, the AOs that accredited Medicare-certified providers and 
suppliers include a statement acknowledging that all accrediting 
organization surveyors have completed or will complete the relevant 
program-specific CMS online trainings established for state surveyors, 
initially, and thereafter. As stated previously, after consideration of 
the numerous comments we received in response to this proposal, we 
decided not to finalize this proposal. Therefore the burden estimates 
provided in the proposed rule regarding the proposed time and cost 
burden related to the requirement that AO surveyors take the CMS online 
surveyor training are no longer relevant.
    The second requirement was to add Sec.  488.5(a)(18)(iii) to would 
require that the AOs for Medicare-certified providers and suppliers 
include a written statement in their application for CMS approval 
agreeing that if a fully accredited and deemed facility in good 
standing provides written notification that they wish to voluntarily 
withdraw from the accrediting organization's CMS-approved accreditation 
program, the accrediting organization must continue the facility's 
current accreditation in full force and effect until the effective date 
of withdrawal identified by the facility or the expiration date of the 
term of accreditation, whichever comes first. As stated previously, we 
have made a decision to finalize this proposal without change or 
modifications.
(1) Burden Associated With the Online Training Requirement for AO 
Surveyors
    A number of commenters expressed concern that the requirement that 
AO surveyors take the CMS online training would impose significant 
burden on the surveyors. Other commenters stated the belief that the AO 
training was adequate and that it was similar to the CMS online 
training, therefore the training requirement would be duplicative. 
Therefore, after consideration of the comments received, we have 
decided not to finalize the proposal to require AO surveyors to take 
the CMS online surveyor training.
(2) Burden Associated With the Statement Requirement for AOs
    We finalized that AOs approved in accordance with section 1865 of 
the Act, and regulated under part 488 subpart A, provide a written 
statement in their application in which they agree to continue a 
provider's or supplier's current accreditation in full force and effect 
until the effective date of withdrawal identified by the facility or 
the expiration date of the term of accreditation, whichever comes 
first.
    Section 488.5(a)(18)(iii) would require the AOs for Medicare-
certified providers and suppliers to include a written statement in 
their application for CMS approval of their accreditation program, 
agreeing that if a fully accredited and deemed facility in good 
standing provides written notification that they wish to voluntarily 
withdraw from the accrediting organization's CMS-approved accreditation 
program, the accrediting organization must continue the facility's 
current accreditation in full force and effect until the effective date 
of withdrawal identified by the facility or the expiration date of the 
term of accreditation, whichever comes first.
    We believe that the AOs that accredit Medicare-certified providers 
and suppliers would incur limited burden associated with this 
requirement, because this regulation simply requires that the AOs to 
include a statement in their application stating that they agree to 
continue the facility's current accreditation in full force and effect 
until the effective date of withdrawal identified by the facility or 
the expiration date of the term of accreditation, whichever comes 
first, if a provider of supplier provides written notification that 
they wish to voluntarily withdraw from the accrediting organization's 
CMS-approved accreditation program. We believe that this written 
statement to be provided by the AO would consist of

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only 1 to 2 paragraphs and would take no more than 15 minutes to 
prepare.
    We believe that a clinicians such as registered nurses would 
prepare the required statement to be included in the AOs application. 
According to the U.S. Bureau of Labor Statistics, the mean hourly wage 
for a registered nurse is $35.36 (https://www.bls.gov/oes/current/oes291141.htm). Therefore, the estimated cost burden to the AOs that 
accredit Medicare-certified providers and suppliers associated with the 
preparation of the required statement would be approximately $17.68 
((15 minutes x $35.36 per hour = $8.84) + ($8.84 for fringe benefits 
and overhead)).
    There are nine AOs that accredit Medicare-certified providers and 
suppliers. The cost across all AOs for the completion of this task 
would be $158.12 (($8.84 x 9 AOs = $79.56) + ($79.56 for fringe 
benefits and overhead)). However, AOs for Medicare-certified providers 
and suppliers are required to submit a renewal application only every 6 
years. Therefore, the existing AOs would be required to submit the 
statement stating that they agree to continue the facility's current 
accreditation in full force and effect until the effective date of 
withdrawal identified by the facility or the expiration date of the 
term of accreditation, whichever comes first, if a provider of supplier 
provides written notification that they wish to voluntarily withdraw 
from the accrediting organization's CMS-approved accreditation program 
with their next renewal application which is submitted after the 
publication of the final rule. While we have calculated the cost for 
the performance of this task across all AOs that accredit Medicare-
certified providers and suppliers, it is important to note that the 
existing AOs are scheduled to submit their renewal applications at 
varying dates and times over a period of several years. Therefore there 
will be no time period in which all of these AOs will incur these 
expenses simultaneously.

D. Detailed Economic Analysis

1. HH PPS
    This rule finalizes updates for the CY 2019 HH PPS rates contained 
in the CY 2018 HH PPS final rule (82 FR 51676 through 51752). The 
impact analysis of this final rule with comment period presents the 
estimated expenditure effects of policy changes in this final rule with 
comment period. 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 2017. We note that certain events may 
combine to limit the scope or accuracy of our impact analysis, because 
such an analysis is future-oriented and, thus, susceptible to errors 
resulting from other changes in the impact time period assessed. Some 
examples of such possible events are newly-legislated general Medicare 
program funding changes made by the Congress, or changes specifically 
related to HHAs. In addition, changes to the Medicare program may 
continue to be made as a result of the Affordable Care Act, or new 
statutory provisions. Although these changes may not be specific to the 
HH PPS, the nature of the Medicare program is such that the changes may 
interact, and the complexity of the interaction of these changes could 
make it difficult to predict accurately the full scope of the impact 
upon HHAs.
a. HH PPS for CY 2019
    Table 44 represents how HHA revenues are likely to be affected by 
the policy changes in this rule for CY 2019. For this analysis, we used 
an analytic file with linked CY 2017 OASIS assessments and HH claims 
data for dates of service that ended on or before December 31, 2017. 
The first column of Table 44 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 2019 wage index and revised labor share. The fourth column shows 
the payment effects of the CY 2019 case-mix weights. The fifth column 
shows the effects of the new rural add-on payment provision in statute. 
The sixth column shows the effects of the revised FDL ratio used to 
calculate outlier payments, and the seventh column shows the effects of 
the CY 2019 home health payment update percentage.
    The last column shows the combined effects of all the policies in 
this rule. Overall, it is projected that aggregate payments in CY 2019 
would increase by 2.2 percent. As illustrated in Table 44, 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 2019 wage index, the extent to which 
HHAs had episodes in case-mix groups where the case-mix weight 
decreased for CY 2019 relative to CY 2018, 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.
BILLING CODE 4120-01-P

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b. HH PPS for CY 2020 (PDGM)
    Table 45 represents how HHA revenues are likely to be affected by 
the policy changes in this rule for CY 2020. For this analysis, we used 
an analytic file with linked CY 2017 OASIS assessments and CY 2017 HH 
claims data (as of March 2, 2018) for dates of service that ended on or 
before December 31, 2017. The first column of Table 45 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 HHAs in the impact analysis. The PDGM, as required 
by Section 51001(a)(2)(A) of the BBA of 2018, will be implemented in a 
budget neutral manner and the third column shows the total impact of 
the PDGM as outlined in section III.F of this final rule with comment 
period. As illustrated in Table 45, the effect of the PDGM varies by 
specific types of providers and location. We note that some individual 
HHAs within the same group may experience different impacts on payments 
than others. This is due to distributional differences among HHAs with 
regards to the percentage of total HH PPS payments that were subject to 
the low-utilization payment adjustment (LUPA) or paid as outlier 
payments, the degree of Medicare utilization, and the ratio of overall 
visits that were provided as therapy versus skilled nursing.
    As outlined in section III.F of this final rule with comment 
period, several OASIS items would no longer be needed to case-mix 
adjust the 30-day payment under the PDGM; therefore, we would make 19 
current OASIS items (48 data elements) optional at the follow-up (FU) 
time point starting January 1, 2020. As also discussed in section 
III.F. of this final rule with comment period, in order to calculate 
the case-mix adjusted payment amount for the PDGM, we would add the 
collection of two current OASIS items (10 data elements) at the FU time 
point starting January 1, 2020. Section X. of this final rule with 
comment period provides a detailed description of the net decrease in 
burden associated with these changes in conjunction with the changes in 
burden that result from OASIS item collection changes due to the 
removal of certain measures required under HH QRP, also effective for 
January 1, 2020 as outlined in section V.E. of this final rule with 
comment period. Due to the modifications to OASIS item collection as a 
result of the changes to the HH QRP and the changes to the HH PPS 
(PDGM), both effective on and after January 1, 2020, we estimate that 
this rule generates $60 million in annualized cost savings, or $46 
million per year on an ongoing basis discounted at 7 percent relative 
to year 2016, over a perpetual time horizon beginning in CY 2020.

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    In response to the CY 2019 case-mix adjustment methodology 
refinements proposed in the CY 2018 HH PPS proposed rule (82 FR 35270), 
a few commenters requested that CMS include more information in the 
impact table for the PDGM, specifically how payments are impacted for 
patients with selected clinical conditions as was included in the 
Technical Report which is available at: https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf. Therefore, we are 
including Table 46 which provides more information on the impact of the 
PDGM case-mix adjustment methodology for patients with selected 
clinical conditions.

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2. HHVBP Model
    Table 47 displays our analysis of the distribution for possible 
payment adjustments at the maximum 7-percent and 8-percent rates that 
will be used in Years 4 and 5 of the Model. These analyses use 
performance year data from 2016, the first year of HHVBP, the most 
recent year for which complete performance year data are available. The 
estimated impacts are for the following finalized changes, each of 
which will take effect beginning with PY4 (2019):
     Remove two OASIS-based measures (Influenza Immunization 
Received for Current Flu Season and Pneumococcal Polysaccharide Vaccine 
Ever Received);
     Replace three OASIS-based measures (Improvement in 
Bathing, Improvement in Bed Transferring, and Improvement in 
Ambulation-Locomotion) with two composite measures (Total Change in 
Self Care, Total Change in Mobility);
     Reduce the maximum possible improvement points from 10 to 
9 (13.5 for the two composite measures); and,
     Change the weights given to the performance measures used 
in the Model so that the OASIS and claims-based measures each count for 
35 percent and the HHCAHPS measures count for 30 percent of the 90 
percent of the Total Performance Score (TPS) that is based on 
performance on the Clinical Quality of Care, Care Coordination and 
Efficiency, and Person and Caregiver-Centered Experience measures. Data 
reporting for each New Measure will continue to have equal weight and 
account for the 10 percent of the TPS that is based on the New Measures 
collected as part of the Model. The weight of the unplanned 
hospitalization measure will also be increased so that it has three 
times the weight of the ED use without hospitalization measure.
    We analyzed the payment adjustment percentage and the number of 
eligible HHAs under current policy to determine the impacts of the 
changes finalized in this rule. We used PY1 (CY2016) data to measure 
the impacts. The data sources for these analyses are data from the QIES 
system for the existing OASIS and claims-based measures, OASIS 
assessments for the two composite measures, HHCAHPS data received from 
the HHCAHPS contractor, and New Measure data submitted by Model 
participants. HHAs are classified as being in the smaller or larger 
volume cohort using the 2016 Quality Episode File, which is created 
using OASIS assessments. We note that this impact analysis is based on 
the aggregate value across all nine Model states.
    Table 48 displays our analysis of the estimated impact of the 
policies finalized in this rule on the number of eligible HHAs and the 
distribution of percentage change in payment adjustment percentage 
based on the same PY1 (CY2016) data used to calculate Table 47. We note 
that this impact analysis is based on the aggregate value across all 
nine Model

[[Page 56616]]

states. Note that all Medicare-certified HHAs that provide services in 
Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, 
Iowa, Nebraska, and Tennessee are required to compete in this Model. 
The analysis is calculated at the state and size cohort level. It is 
expected that a certain number of HHAs would not have a payment 
adjustment because they may be servicing too small of a population to 
report an adequate number of measures to calculate a TPS. Table 48 
shows that there would be a reduction in the number of HHAs that would 
have a sufficient number of measures to receive a payment adjustment 
for performance year 4 of 31 HHAs (Change column), a decrease from 
1,610 HHAs (Current column) to 1,579 HHAs (Simulated column) across the 
nine selected states.
    This analysis reflects only HHAs that would have data for at least 
five measures that meet the requirements of Sec.  484.305 and would be 
included in the Linear Exchange Function and would have a payment 
adjustment calculated. Value-based incentive payment adjustments for 
the estimated eligible 1,579 HHAs in the selected states that would 
compete in the HHVBP Model are stratified by size as described in 
section IV.B. of the CY 2017 HH PPS final rule. As finalized in section 
IV.B. of the CY 2017 final rule, there must be a minimum of eight HHAs 
in any cohort.
    Those HHAs that are in states that do not have at least eight 
smaller-volume HHAs will not have a separate smaller-volume cohort and 
thus there will only be one cohort that will include all the HHAs in 
that state. As indicated in Table 48, Maryland, North Carolina, 
Tennessee, Washington, and Arizona would have only one cohort while 
Florida, Iowa, Massachusetts, and Nebraska would have both a smaller-
volume cohort and a larger-volume cohort. For example, Iowa would have 
17 HHAs eligible to be exempt from being required to have their 
beneficiaries' complete HHCAHPS surveys because they provide HHA 
services to less than 60 beneficiaries. Therefore, those 17 HHAs would 
be competing in Iowa's smaller-volume cohort for CY 2019 (PY4) under 
the Model.
    Table 48 shows the distribution of percentage change in payment 
adjustment percentage resulting from the policies finalized in this 
rule. Using 2016 data and the maximum payment adjustment for 
performance year 4 of 7 percent (as applied in CY 2021), based on the 
six finalized OASIS quality measures and two claims-based measures in 
QIES, the five HHCAHPS measures, and the three New Measures, we see 
that, across all nine states, 31 HHAs would no longer be eligible for a 
payment adjustment for PY4 because they would not have data on at least 
five measures that meet the requirements of Sec.  484.305. The 
distribution of scores by percentile shows the distribution of the 
change in percent payment adjustment. For example, the distribution for 
HHAs in Florida in the smaller-volume cohort ranges from -2.5 percent 
at the 10th percentile to +2.9 percent at the 90th percentile. This 
means that, for 7 of the 77 HHAs in the smaller-volume cohort in 
Florida, the changes would decrease their payment adjustment percentage 
by -2.5 percent or more while, for another 7 HHAs these changes would 
increase their payment adjustment percentage by 2.9 percent or more. 
For half of the HHAs in Florida's smaller volume cohort, the impact of 
these changes on their payment adjustment percentage would be between -
1.1 percent and +1.3 percent. These impact analyses suggest that, for 
most participating HHAs, the impacts of the changes would be modest.
    Table 49 provides the payment adjustment distribution based on 
agency size, proportion of dually-eligible beneficiaries, average case 
mix (using the average case-mix for non-LUPA episodes), the proportion 
of the HHA's beneficiaries that reside in rural areas and HHA 
organizational status. HHAs with a higher proportion of dually-eligible 
beneficiaries and HHAs whose beneficiaries have higher acuity tend to 
have a more negative impact associated with the policies finalized in 
this rule based on the 50th percentile of the impact of the changes on 
payment adjustment percentage.
    Table 50 shows the current and revised weights, as finalized in 
this rule, for individual performance measures by measure category and 
possible applicable measure category scenarios to demonstrate the 
weight of the individual measures when an HHA has scores on All 
Measures or if an HHA is missing all measures in a measure category. 
For example, for an HHA that has quality measure scores on All Measures 
in all the measure categories (OASIS-based, claims-based and HHCAHPS) 
under the current weighting method, the individual measures are 
weighted equally. The Finalized Weights columns show the revised 
weights for the individual performance measures based on the changes to 
the weighting methodology finalized in this final rule with comment 
period; specifically, to weight the measure categories so that the 
OASIS-based measure category and the claims-based measure category will 
each count for 35 percent and the HHCAHPS measure category will count 
for 30 percent of the 90 percent of the TPS that is based on 
performance of the Clinical Quality of Care, Care Coordination and 
Efficiency, and Person and Caregiver-Centered Experience measures. For 
example, for HHAs with scores on All Measures, the OASIS-based measures 
account for 35 percent, with equal weighting given to the Improvement 
in Oral Medications, Improvement in Dyspnea, Improvement in Pain, and 
Discharge to Community measures. The Composite Self-Care and Composite 
Mobility measures will be weighted 1.5 times more than the other OASIS-
based measures so that the maximum score for the two composite measures 
is the same as for the three functional OASIS-based measures that they 
are replacing (Improvement in Ambulation, Bathing and Bed 
Transferring). Under the revised weights, the two claims-based 
measures, which will collectively account for 35 percent, will not be 
weighted equally. We are finalizing that the weight of the acute care 
hospitalization measure will be three times higher than that of the ED 
Use measure. Thus, its weight will be 26.25 percent while the weight of 
the ED Use measure will be 8.75 percent for an HHA that reported on all 
measures. The HHCAHPS measures will account for 30 percent and each 
measure will be weighted equally.
    Table 50 also shows the number of HHAs that would have enough 
measures to receive a payment adjustment under each possible scoring 
scenario under both the current and revised weighting methodologies. 
Most of the HHAs that would no longer receive a payment adjustment with 
the changes finalized in this rule are those with no claims or HHCAHPS 
measures. With only OASIS measures, these HHAs are more impacted by the 
finalized policy to remove the two immunization measures and the 
finalized policy to replace three OASIS functional measures with the 
two composite measures. The number of HHAs without claims or HHCAHPS 
measures that would have enough OASIS-based measures to receive a 
payment adjustment would drop from 99 to 73 (a decrease of 26 HHAs), 
and the majority of these HHAs would be smaller HHAs (16 of the 26 
HHAs).

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3. HH QRP
    Failure to submit data required under section 1895(b)(3)(B)(v) of 
the Act with respect to a calendar year will result in the reduction of 
the annual home health market basket percentage increase otherwise 
applicable to a HHA for that calendar year by 2 percentage points. In 
section V.G. of this final rule with comment period, we revised our 
regulations at Sec.  484.250(a) to clarify that not all OASIS data 
described in Sec.  484.55(b) and (d) are needed for purposes of 
complying with the requirements of the HH QRP. There are no changes in 
this final rule with comment period in our method for applying the 2 
percentage point reduction to HHAs that fail to meet the HH QRP 
requirements. For the CY 2018 annual payment update determination, 
1,311 of the 11,776 active Medicare-certified HHAs, or approximately 
11.1 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 2019 payment determination.
    In section V.E. of this final rule with comment period, we are 
removing seven measures from the HH QRP: Depression Assessment 
Conducted, Diabetic Foot Care and Patient/Caregiver Education 
Implemented during All Episodes of Care, Multifactor Fall Risk 
Assessment Conducted For All Patients Who Can Ambulate (NQF #0537), 
Pneumococcal Polysaccharide Vaccine Ever Received, Improvement in the 
Status of Surgical Wounds, Emergency Department Use without Hospital 
Readmission during the First 30 Days of HH (NQF #2505), and 
Rehospitalization during the First 30 Days of HH (NQF #2380). Their 
associated burden decreases are for CY 2020 because HHAs will no longer 
be required to submit data on these measures beginning CY 2020. As 
noted previously, section X. of this final rule with comment period 
provides a detailed description of the net decrease in burden 
associated with these changes in conjunction with the changes in burden 
that result from the implementation of the PDGM for CY 2020. Due to the 
modifications to OASIS item collection as a result of the changes to 
the HH QRP and the changes to the HH PPS (PDGM), both effective on and 
after January 1, 2020; we estimate that this rule generates $60 million 
in annualized cost savings, or $46 million per year on an ongoing basis 
discounted at 7 percent relative to year 2016, over a perpetual time 
horizon beginning in CY 2020.
4. Home Infusion Therapy Payment
    The following analysis applies to the Temporary Transitional 
Payment for Home Infusion Therapy as set forth in section 1834(u)(7) of 
the Act, as added by section 50401 of the BBA of 2018 (Pub. L. 115-
123), and accordingly, describes the impact for CY 2019 only. Table 51 
represents the estimated increased Medicare costs of existing 
beneficiaries who are furnished DME and are currently using home 
infusion therapy services. We used CY 2017 data to identify 
beneficiaries with DME claims containing 1 of the 37 HCPCS codes 
identified in section 1834(u)(7)(C) of the Act, which are shown in 
column 2. In column 3, 2017 claims were again used to determine the 
total weeks of care, which is the sum of weeks of care across all 
beneficiaries found in each category. Weeks of care for payment 
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, 47, as 
many patients use immune globulin for the whole year. Column four 
assumes the initial week of care requires two nurse visits, and all 
subsequent weeks only require one visit, in order to estimate the total 
visits of care per category. In general, nursing visits for payment 
category 2, subcutaneous immune globulin (SCIG) administration, occur 
once per month; therefore, we assume the estimated number of visits for 
these patients is 12. The fifth column multiplies the volume of nurse 
visits across beneficiaries by the payment rate (using the 2018 
Physician Fee Schedule amounts) in order to estimate the increased cost 
per each of the three infusion drug categories.\87\ At the time of 
publication, we did not have the 2019 Physician Fee Schedule rate in 
order to complete our impact analysis; however, actual payments 
starting on January 1, 2019 would be based on the Physician Fee 
Schedule amounts as specified in section 50401 of the BBA of 2018.
---------------------------------------------------------------------------

    \87\ Based on the 2018 Medicare PFS these rates are $141.12 
($74.16 + 3 * $22.32) for Category 1, $224.28 ($176.76 + 3 * $15.84) 
for Category 2, and $239.76 ($144.72 + 3 * $31.68) for Category 3.
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    Table 52 displays the estimated regional impacts using the 
beneficiary enrollment address reported in the Medicare Master 
Beneficiary Summary File. Table 53 displays impacts based on rural or 
urban designations. All beneficiaries identified had at least one 
applicable home infusion claim (claims with 1 of the 37 drug codes 
listed in section 1834(u)(7)(C) of the Act) in CY 2017. Unknown 
beneficiaries were those without valid state and county

[[Page 56622]]

information in the Master Beneficiary Summary File. Additionally, the 
tables provide the estimated impacts by drug category.
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E. Alternatives Considered

1. HH PPS
a. HH PPS for CY 2019
    Section 1895(b)(3)(B) of the Act requires that the standard 
prospective payment amounts for CY 2019 be increased by a factor equal 
to the applicable HH market basket update for those HHAs that submit 
quality data as required by the Secretary. For CY 2019, Section 
1895(b)(3)(B)(vi) of the Act requires that the market basket update 
under the HHA prospective payment system be adjusted by changes in 
economy-wide productivity. The 0.8 percentage point multifactor 
productivity adjustment to the CY 2019 home health market basket update 
of 3.0 percent, is discussed in the preamble of this final rule with 
comment period and is not discretionary as it is a requirement in 
section 1895(b)(3)(B)(vi)(I) of the Act.
    We considered not rebasing the home health market basket. However, 
we believe that it is desirable to rebase the home health market basket 
periodically so that the cost category weights reflect changes in the 
mix of goods and services that HHAs purchase in furnishing home health 
care. In addition, we considered not implementing the revision to the 
labor-related share of 76.1 percent in a budget neutral manner. 
However, we believe it is more prudent to implement the revision to the 
labor-related share in a manner that does not increase or decrease 
budgetary expenditures.
    With regards to payments made under the HH PPS for high-cost 
outlier episodes of care (that is, episodes of care with unusual 
variations in the type or amount of medically necessary care), we did 
not consider maintaining the current FDL ratio of 0.55. As discussed in 
section III.E.3. of this final rule with comment period, we revise the 
FDL ratio to 0.51. Simulations using CY 2017 claims data and the CY 
2019 HH PPS payment rates resulted in an estimated 2.32 percent of 
total HH PPS payments being paid as outlier payments using the existing 
methodology for calculating the cost of an episode of care. The FDL 
ratio and the loss-sharing ratio must be selected so that the estimated 
outlier payments do not exceed the 2.5 percent of total HH PPS payments 
(as required by section 1895(b)(5)(A) of the Act). Therefore, lowering 
the FDL ratio results in 2.32% in outlier payments that rises closer to 
but does not exceed the 2.5% in total outlier payments. We did not 
consider proposing a change to the loss sharing ratio (0.80) in order 
for the HH PPS to remain consistent with payment for high-cost outliers 
in other Medicare payment systems (for example, IRF PPS, IPPS, etc.)
b. HH PPS for CY 2020 (PDGM)
    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. 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 these measures to be implemented on January 1, 2020 
and 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.
    Alternatives to making 19 current OASIS items (48 data elements) 
optional at the FU time point as outlined in section X. of this final 
rule with comment period, would be to either not implement the case-mix 
adjustment methodology changes under the PDGM or to continue collecting 
the 19 current OASIS items at the FU time point, even though they would 
not be used to case-mix adjust payments under the PDGM. Similarly, an 
alternative to adding collection of two current OASIS items (10 data 
elements) at the FU time point as discussed in section X. of this final 
rule with comment period would be to either not adopt the PDGM or not 
to include the two current OASIS items (M1800 and M1033) as part of the 
case-mix adjustment methodology under the PDGM. As noted previously, we 
did not consider not implementing the case-mix methodology changes 
under the PDGM as a new case-mix adjustment methodology is required to 
be implemented in accordance with section 51001 of the BBA of 2018, 
which mandates the elimination of the use of therapy thresholds for 
case-mix adjustment purposes by January 1, 2020. We believe that 
continuing to require HHAs to report responses for the 19 current OASIS 
items at the FU time point that are no longer needed for case-mix 
adjustment purposes under the PDGM results in unnecessary burden for 
HHAs. While requiring HHAs to report responses for two current OASIS 
items at the FU time point results in a small increase in burden if CMS 
were to not make 19 current OASIS items optional at the FU time point, 
those two OASIS items (M1800 and M1033) are correlated with increases 
in resource use and are used to determine the patient's functional 
impairment level under the HHGM, thus they are important for case-mix 
adjustment purposes in order to ensure accurate payments to HHAs under 
the PDGM.
    We considered whether to continue using the wage-weighted minutes 
of care (WWMC) approach to estimate resource use under the PDGM, as 
described in section III.F.2. of this final rule with comment period. 
Although the relationship in relative costs between the WWMC approach 
and the cost-per-minute plus non-routine supplies (CPM+NRS) approach is 
very similar (correlation coefficient equal to 0.8512), the WWMC 
approach does not as evenly weight skilled nursing costs relative to 
therapy costs as evidenced in the cost report data and would require us 
to maintain a separate case-mix adjustment mechanism for NRS. If we 
were to maintain the current WWMC approach, skilled nursing and therapy 
costs would not be as evenly weighted and a certain level of complexity 
in calculating payments under the HH PPS would persist as we would need 
to continue with the current method of case-mix adjusting NRS payments 
separate from service costs (that is, skilled nursing, physical 
therapy, occupational therapy, speech-language pathology, home health 
aide, and medical social services) under the HH PPS.
    In this final rule with comment period and to begin in CY 2020, we 
considered proposing a phase-out of the split percentage payment 
approach by reducing the percentage of the upfront payment over a 
period of time and requiring a notice of admission (NOA) to be 
submitted upon full elimination of the split-percentage payment. 
However, we wanted to take the opportunity in this year's rule to more 
clearly signal our intent to potentially eliminate the split percentage 
payment approach over time as a reduced timeframe for the unit of 
payment (30 days rather than 60 days) is now required in statute. Given 
that existing HHAs (certified with effective dates prior to January 1, 
2019) would need to adapt to changes in cash flow with the elimination 
of the split percentage payment approach, we hope to receive additional 
feedback on the timeframes for a phase-out of the split percentage 
payment approach and whether there is a need for an NOA upon completion 
of a phase-out of the split percentage payment approach that we can 
take into consideration for potential future rulemaking.

[[Page 56625]]

2. HHVBP Model
    We considered various alternatives to our proposals for the HHVBP 
Model. For the vaccination measures, we considered continuing to 
include them in the applicable measure set instead of removing them. 
However, for the reasons discussed in section IV of this final rule 
with comment period, we are finalizing our proposal to remove the two 
vaccination measures beginning with PY4.
    With regard to our proposal to replace three OASIS-based measures 
with two composite measures, we also considered making no changes to 
the OASIS-based measures category.
    Another alternative to this proposal would be to finalize one but 
not both composite measures. We discussed in the proposed rule the 
proposed scoring that would apply if we adopted this alternative. 
However, for the reasons discussed in section IV.B of this final rule 
with comment period, we are finalizing the replacement of the three 
OASIS-based measures with the two new composite measures.
    An alternative to rescoring the maximum improvement points from 10 
points to 9 points would be to keep the current scoring methodology. 
However, for the reasons discussed in section IV.B in this final rule 
with comment period, we are finalizing our proposal to rescore the 
maximum improvement points from 10 points to 9 points (or 13.5 points 
for the composite measures).
    An alternative to reweighting the OASIS-based, claims-based and 
HHCAHPS measure categories would be to keep the current equally 
weighted methodology. For the reasons discussed in section IV.B of this 
final rule with comment period, we are finalizing reweighting of the 
OASIS-based measure category to 35 percent, the claims-based measure 
category to 35 percent and the HHCAHPS measure category to 30 percent 
in order to encourage increased focus on the claims-based measures.
3. HH QRP
    An alternative to removing seven measures from the HH QRP 
(Depression Assessment Conducted, Diabetic Foot Care and Patient/
Caregiver Education Implemented during All Episodes of Care, 
Multifactor Fall Risk Assessment Conducted For All Patients Who Can 
Ambulate (NQF #0537), Pneumococcal Polysaccharide Vaccine Ever 
Received, Improvement in the Status of Surgical Wounds, Emergency 
Department Use without Hospital Readmission during the First 30 Days of 
HH (NQF #2505), Rehospitalization during the First 30 Days of HH (NQF 
#2380)), as discussed in section V.E. of this final rule with comment 
period, would have been to retain these measures in the HH QRP.
4. Home Infusion Therapy
a. Health and Safety Standards
    We considered establishing additional health and safety 
requirements related to patient assessment, infection control and 
quality improvement. However, according to the home infusion therapy 
supplier industry, and our research, we believe there are already some 
AOs that include requirements related to patient assessment, quality 
improvement, and infection control. To the extent that we subsequently 
determine that federal standards are necessary, we will propose them in 
subsequent notice and comment rulemaking.
b. Payment
    We did not consider alternatives to implementing the home infusion 
therapy benefit for CY 2019 and 2020 because section 1834(u)(7) of the 
Act requires the Secretary to provide a temporary transitional payment 
to eligible home infusion therapy suppliers for items and services 
associated with the furnishing of transitional home infusion drugs.
c. Accreditation of Qualified Home Infusion Therapy Suppliers
    AOs that accredit home infusion therapy suppliers must become 
accredited by an AO designated by the Secretary. In these options, we 
have attempted to minimize the burden of accreditation on home infusion 
therapy suppliers, which include approving home infusion therapy AOs 
that consider the unique needs of small home infusion therapy 
suppliers. Also, it is likely that the surveys of home infusion therapy 
suppliers would be performed as a desk review instead of an onsite 
survey. Doing a desk audit survey would prevent the travel time and 
cost that is required when the AO has to send a survey team to the home 
infusion therapy supplier's location to perform an onsite survey.

F. Accounting Statement and Tables

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars_a004_a-4), in Table 54, we have 
prepared an accounting statement showing the classification of the 
transfers and costs associated with the CY 2019 HH PPS provisions of 
this rule. For CY 2020, due to the section 51001(a) of the BBA of 2018 
requirement that the transition to the 30-day unit of payment be budget 
neutral, Table 55 displays a transfer of zero. Table 56 provides our 
best estimates of the changes to OASIS item collection as a result of 
the implementation of the PDGM and changes to the HH QRP. Table 57 
provides our best estimate of the increase in Medicare payments to home 
infusion therapy suppliers related to the temporary transitional 
payment for home infusion therapy in CY 2019. Table 58 provides our 
best estimate of cost of AO compliance with our home infusion the 
Infusion Therapy application requirements.
[GRAPHIC] [TIFF OMITTED] TR13NO18.091


[[Page 56626]]


[GRAPHIC] [TIFF OMITTED] TR13NO18.092

[GRAPHIC] [TIFF OMITTED] TR13NO18.093

[GRAPHIC] [TIFF OMITTED] TR13NO18.094

[GRAPHIC] [TIFF OMITTED] TR13NO18.095

BILLING CODE 4120-01-C

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.'' 
Details on the estimated costs of this final rule with comment period, 
including limitations on the ability thus far to quantify some 
categories of impacts, can be found in the rule's economic analysis. 
This final rule with comment period is considered an E.O. 13771 
deregulatory action. Details on the estimated cost savings of this 
final rule with comment period can be found in the rule's PRA and 
economic analysis. Due to the modifications to OASIS item collection as 
a result of the changes to the HH QRP and the changes to the HH PPS 
(PDGM), both effective on and after January 1, 2020, we estimate that 
this rule generates $60 million in annualized cost savings, or $46 
million per year on an ongoing basis discounted at 7 percent relative 
to year 2016, over a perpetual time horizon beginning in CY 2020.

H. Conclusion

1. HH PPS
a. HH PPS for CY 2019
    In conclusion, we estimate that the net impact of the HH PPS 
policies in this rule is an increase of 2.2 percent, or $420 million, 
in Medicare payments to HHAs for CY 2019. The $420 million increase 
reflects the effects of the CY 2019 home health payment update of 2.2 
percent ($420 million increase), a 0.1 percent increase in payments due 
to decreasing the FDL ratio in order to target to pay no more than 2.5 
percent of total payments as outlier payments ($20 million increase), 
and a -0.1 percent decrease in CY 2019 payments due to the new rural 
add-on policy mandated by the BBA of 2018 ($20 million decrease).
b. HH PPS for CY 2020 (PDGM)
    In conclusion, we estimate that Medicare payments to HHAs for CY 
2020 will remain the same compared to CY 2019 as a result of the 
implementation of the PDGM. Section 51001(a) of the BBA of 2018 
requires the Secretary to implement the 30-day unit of payment in a 
budget-neutral manner.
2. OASIS Changes Related to the HH QRP and HH PPS (PDGM) for CY 2020
    In conclusion, we estimate that the changes to OASIS item 
collection as a result of the changes to the HH QRP and the changes to 
the HH PPS (PDGM), both effective on and after January 1, 2020, would 
result in a net $60 million in annualized cost savings, discounted at 7 
percent relative to year 2016, over

[[Page 56627]]

a perpetual time horizon beginning in CY 2020.
    In conclusion, due to the modifications to OASIS item collection as 
a result of the changes to the HH QRP and the changes to the HH PPS 
(PDGM), both effective on and after January 1, 2020, we estimate that 
this rule generates $60 million in annualized cost savings, or $46 
million per year on an ongoing basis discounted at 7 percent relative 
to year 2016, over a perpetual time horizon beginning in CY 2020.
4. Home Infusion Therapy
a. Health and Safety Standards
    In summary, the health and safety standards would not have any 
economic impact on home infusion therapy suppliers or accreditation 
organizations.
b. Payment
    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 would result in approximately $48 million in additional Medicare 
payments to home infusion suppliers in CY 2019.
c. Accreditation of Qualified Home Infusion Therapy Suppliers
    In summary, AOs that accredit HIT suppliers must become accredited 
by an AO designated by the Secretary. In these options, we have 
attempted to minimize the burden of accreditation on HIT suppliers, 
which include approving AOs that consider the unique needs of small HIT 
suppliers. Also, it is likely that the surveys of HIT suppliers will be 
performed as a desk review instead of an onsite survey. Doing a desk 
audit survey would prevent the travel time and cost that is required 
when the AO has to send a survey team to the HIT supplier's location to 
perform an onsite survey.
    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 
finalized rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare, Reporting and recordkeeping requirements.

42 CFR Part 484

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

42 CFR Part 486

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

42 CFR Part 488

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

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 409--HOSPITAL INSURANCE BENEFITS

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

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


Sec.  409.43  [Amended]

0
2. Section 409.43 is amended--
0
a. By removing paragraph (c)(2);
0
b. By resignating paragraphs (c)(3) and (4) as paragraphs (c)(2) and 
(3);
0
c. In newly redesignated paragraph (c)(2)(ii) by removing the phrase 
``for services is submitted for the final percentage prospective 
payment'' and adding in its place the phrase ``(for episodes beginning 
on or before December 31, 2019) or 30-day period (for periods beginning 
on or after January 1, 2020) is submitted''; and
0
d. In paragraph (e)(1)(iii) by removing the phrase ``during the 60-day 
episode'' and adding in its place the phrase ``within 60 days''.
0
3. Section 409.46 is amended by adding paragraph (e) to read as 
follows:


Sec.  409.46  Allowable administrative costs.

* * * * *
    (e) Remote patient monitoring. Remote patient monitoring is defined 
as the collection of physiologic data (for example, ECG, blood 
pressure, or glucose monitoring) digitally stored and transmitted by 
the patient or caregiver or both to the home health agency. If remote 
patient monitoring is used by the home health agency to augment the 
care planning process, the costs of the equipment, set-up, and service 
related to this system are allowable only as administrative costs. 
Visits to a beneficiary's home for the sole purpose of supplying, 
connecting, or training the patient on the remote patient monitoring 
equipment, without the provision of a skilled service are not 
separately billable.

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
4. The authority citation for part 424 continues to read as follows:

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

0
5. Section 424.22 is amended by revising paragraphs (b)(2) and (c) to 
read as follows:


Sec.  424.22  Requirements for home health services.

* * * * *
    (b) * * *
    (2) Content and basis of recertification. As a condition for 
payment of home health services under Medicare Part A or Medicare Part 
B, if there is a continuing need for home health services, a physician 
must recertify the patient's continued eligibility for the home health 
benefit as outlined in sections 1814(a)(2)(C) and 1835(a)(2)(A) of the 
Act, as set forth in paragraph (a)(1) of this section, and as specified 
in paragraphs (b)(2)(i) and (ii) of this section.
    (i) Need for occupational therapy may be the basis for continuing 
services that were initiated because the individual needed skilled 
nursing care or physical therapy or speech therapy.
    (ii) If a patient's underlying condition or complication requires a 
registered nurse to ensure that essential non-skilled care is achieving 
its purpose, and necessitates a registered nurse be involved in the 
development, management, and evaluation of a patient's care plan, the 
physician must include a brief narrative describing the clinical 
justification of this need. If the narrative--
    (A) Is part of the recertification form, then the narrative must be 
located immediately prior to the physician's signature.
    (B) Exists as an addendum to the recertification form, in addition 
to the physician's signature on the recertification form, the physician 
must sign immediately following the narrative in the addendum.
    (c) Determining patient eligibility for Medicare home health 
services. (1) Documentation in the certifying physician's medical 
records or the acute/post-acute care facility's medical records (if the 
patient was directly admitted to home health) or both must be used as 
the basis for certification of the patient's eligibility for home 
health as described in paragraphs (a)(1) and (b) of this section. 
Documentation from the HHA may also be used to support the basis for 
certification of home health eligibility, but only if the following 
requirements are met:

[[Page 56628]]

    (i) The documentation from the HHA can be corroborated by other 
medical record entries in the certifying physician's medical record for 
the patient or the acute/post-acute care facility's medical record for 
the patient or both, thereby creating a clinically consistent picture 
that the patient is eligible for Medicare home health services.
    (ii)(A) The certifying physician signs and dates the HHA 
documentation demonstrating that the documentation from the HHA was 
considered when certifying patient eligibility for Medicare home health 
services.
    (B) HHA documentation can include, but is not limited to, the 
patient's plan of care required under Sec.  409.43 of this chapter, or 
the initial or comprehensive assessment of the patient required under 
Sec.  484.55 of this chapter.
    (2) The documentation must be provided upon request to review 
entities or CMS or both. If the documentation used as the basis for the 
certification of eligibility is not sufficient to demonstrate that the 
patient is or was eligible to receive services under the Medicare home 
health benefit, payment is not rendered for home health services 
provided.
* * * * *

PART 484--HOME HEALTH SERVICES

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

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

0
7. Section 484.202 is amended by revising the definitions of ``Rural 
area'' and ``Urban area'' to read as follows:


Sec.  484.202  Definitions.

* * * * *
    Rural area means an area defined in Sec.  412.64(b)(1)(ii)(C) of 
this chapter.
    Urban area means an area defined in Sec.  412.64(b)(1)(ii)(A) and 
(B) of this chapter.

0
8. Section 484.205 is revised to read as follows:


Sec.  484.205  Basis of payment.

    (a) Method of payment. An HHA receives a national, standardized 
prospective payment amount for home health services previously paid on 
a reasonable cost basis (except the osteoporosis drug defined in 
section 1861(kk) of the Act) as of August 5, 1997. The national, 
standardized prospective payment is determined in accordance with Sec.  
484.215.
    (b) Unit of payment--(1) Episodes before December 31, 2019. For 
episodes beginning on or before December 31, 2019, an HHA receives a 
unit of payment equal to a national, standardized prospective 60-day 
episode payment amount.
    (2) Periods on or after January 1, 2020. For periods beginning on 
or after January 1, 2020, a HHA receives a unit of payment equal to a 
national, standardized prospective 30-day payment amount.
    (c) OASIS data. A HHA must submit to CMS the OASIS data described 
at Sec.  484.55(b) and (d) in order for CMS to administer the payment 
rate methodologies described in Sec. Sec.  484.215, 484.220, 484. 230, 
484.235, and 484.240.
    (d) Payment adjustments. The national, standardized prospective 
payment amount represents payment in full for all costs associated with 
furnishing home health services and is subject to the following 
adjustments and additional payments:
    (1) A low-utilization payment adjustment (LUPA) of a predetermined 
per-visit rate as specified in Sec.  484.230.
    (2) A partial payment adjustment as specified in Sec.  484.235.
    (3) An outlier payment as specified in Sec.  484.240.
    (e) Medical review. All payments under this system may be subject 
to a medical review adjustment reflecting the following:
    (1) Beneficiary eligibility.
    (2) Medical necessity determinations.
    (3) Case-mix group assignment.
    (f) Durable medical equipment (DME) and disposable devices. DME 
provided as a home health service as defined in section 1861(m) of the 
Act is paid the fee schedule amount. Separate payment is made for 
``furnishing NPWT using a disposable device,'' as that term is defined 
in Sec.  484.202, and is not included in the national, standardized 
prospective payment.
    (g) Split percentage payments. Normally, there are two payments 
(initial and final) paid for an HH PPS unit of payment. The initial 
payment is made in response to a request for anticipated payment (RAP) 
as described in paragraph (h) of this section, and the residual final 
payment is made in response to the submission of a final claim. Split 
percentage payments are made in accordance with requirements at Sec.  
409.43(c) of this chapter.
    (1) Split percentage payments for episodes beginning on or before 
December 31, 2019--(i) Initial and residual final payments for initial 
episodes on or before December 31, 2019. (A) The initial payment for 
initial episodes is paid to an HHA at 60 percent of the case-mix and 
wage-adjusted 60-day episode rate.
    (B) The residual final payment for initial episodes is paid at 40 
percent of the case-mix and wage-adjusted 60-day episode rate.
    (ii) Initial and residual final payments for subsequent episodes 
before December 31, 2019. (A) The initial payment for subsequent 
episodes is paid to an HHA at 50 percent of the case-mix and wage-
adjusted 60-day episode rate.
    (B) The residual final payment for subsequent episodes is paid at 
50 percent of the case-mix and wage-adjusted 60-day episode rate.
    (2) Split percentage payments for periods beginning on or after 
January 1, 2020--(i) Initial and residual final payments for initial 
periods beginning on or after January 1, 2020. (A) The initial payment 
for initial 30-day periods is paid to an HHA at 60 percent of the case-
mix and wage-adjusted 30-day payment rate.
    (B) The residual final payment for initial 30-day periods is paid 
at 40 percent of the case-mix and wage-adjusted 30-day payment rate.
    (ii) Initial and residual final payments for subsequent periods 
beginning on or after January 1, 2020. (A) The initial payment for 
subsequent 30-day periods is paid to an HHA at 50 percent of the case-
mix and wage-adjusted 30-day payment rate.
    (B) The residual final payment for subsequent 30-day periods is 
paid at 50 percent of the case-mix and wage-adjusted 30-day payment 
rate.
    (iii) Split percentage payments on or after January 1, 2019. Split 
percentage payments are not made to HHAs that are certified for 
participation in Medicare effective on or after January 1, 2019. 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.
    (h) Requests for anticipated payment (RAP). (1) HHAs that are 
certified for participation in Medicare effective by December 31, 2018 
submit requests for anticipated payment (RAPs) to request the initial 
split percentage payment as specified in paragraph (g) of this section. 
HHAs that are certified for participation in Medicare effective on or 
after January 1, 2019 are still required to submit RAPs although no 
split percentage payments are made in response to these RAP 
submissions. The HHA can submit a RAP when all of the following 
conditions are met:
    (i) After the OASIS assessment required at Sec.  484.55(b)(1) and 
(d) is complete, locked or export ready, or there is an agency-wide 
internal policy establishing the OASIS data is finalized for 
transmission to the national assessment system.

[[Page 56629]]

    (ii) Once a physician's verbal orders for home care have been 
received and documented as required at Sec. Sec.  484.60(b) and 
409.43(d) of this chapter.
    (iii) A plan of care has been established and sent to the physician 
as required at Sec.  409.43(c) of this chapter.
    (iv) The first service visit under that plan has been delivered.
    (2) A RAP is based on the physician signature requirements in Sec.  
409.43(c) of this chapter and is not a Medicare claim for purposes of 
the Act (although it is a ``claim'' for purposes of Federal, civil, 
criminal, and administrative law enforcement authorities, including but 
not limited to the following:
    (i) Civil Monetary Penalties Law (as defined in 42 U.S.C. 1320a-
7a(i)(2)).
    (ii) The Civil False Claims Act (as defined in 31 U.S.C. 3729(c)).
    (iii) The Criminal False Claims Act (18 U.S.C. 287)).
    (iv) The RAP is canceled and recovered unless the claim is 
submitted within the greater of 60 days from the end date of the 
appropriate unit of payment, as defined in paragraph (b) of this 
section, or 60 days from the issuance of the RAP.
    (3) CMS has the authority to reduce, disprove, or cancel a RAP in 
situations when protecting Medicare program integrity warrants this 
action.


Sec.  484.210   [Removed and Reserved]

0
9. Section 484.210 is removed and reserved.

0
10. Section 484.215 is amended--
0
a. By revising the section heading;
0
b. In paragraph (d) introductory text by removing the phrase ``CMS 
calculates the'' and adding in its place the phrase ``For episodes 
beginning on or before December 31, 2019, CMS calculates the''; and
0
c. By adding paragraph (f).
    The revision and addition reads as follows:


Sec.  484.215  Initial establishment of the calculation of the 
national, standardized prospective payment rates.

* * * * *
    (f) For periods beginning on or after January 1, 2020, a national, 
standardized prospective 30-day payment rate applies. The national, 
standardized prospective 30-day payment rate is an amount determined by 
the Secretary, as subsequently adjusted in accordance with Sec.  
484.225.

0
11. Section 484.220 is amended--
0
a. By revising the section heading and introductory text; and
0
b. In paragraph (a) introductory text by removing the phrase ``national 
prospective 60-day episode'' and adding in its place the phrase 
``national, standardized prospective''.
    The revisions read as follows:


Sec.  484.220  Calculation of the case-mix and wage area adjusted 
prospective payment rates.

    CMS adjusts the national, standardized prospective payment rates as 
referenced in Sec.  484.215 to account for the following:
* * * * *

0
12. Section 484.225 is amended--
0
a. By revising the section heading and paragraph (a);
0
b. In paragraphs (b) and (c) by removing the phrase ``national 
prospective 60-day episode'' and adding in its place the phrase 
``national, standardized prospective''; and
0
c. By adding paragraph (d).
    The revision and addition reads as follows:


Sec.  484.225  Annual update of the unadjusted national, standardized 
prospective payment rates.

    (a) CMS annually updates the unadjusted national, standardized 
prospective payment rate on a calendar year basis (in accordance with 
section 1895(b)(1)(B) of the Act).
* * * * *
    (d) For CY 2020, the national, standardized prospective 30-day 
payment amount is an amount determined by the Secretary. CMS annually 
updates this amount on a calendar year basis in accordance with 
paragraphs (a) through (c) of this section.

0
13. Section 484.230 is revised to read as follows:


Sec.  [thinsp]484.230  Low-utilization payment adjustments.

    (a) For episodes beginning on or before December 31, 2019, an 
episode with four or fewer visits is paid the national per-visit amount 
by discipline determined in accordance with Sec.  484.215(a) and 
updated annually by the applicable market basket for each visit type, 
in accordance with Sec.  484.225.
    (1) The national per-visit amount is adjusted by the appropriate 
wage index based on the site of service of the beneficiary.
    (2) An amount is added to the low-utilization payment adjustments 
for low-utilization episodes that occur as the beneficiary's only 
episode or initial episode in a sequence of adjacent episodes.
    (3) For purposes of the home health PPS, a sequence of adjacent 
episodes for a beneficiary is a series of claims with no more than 60 
days without home care between the end of one episode, which is the 
60th day (except for episodes that have been PEP-adjusted), and the 
beginning of the next episode.
    (b) For periods beginning on or after January 1, 2020, an HHA 
receives a national 30-day payment of a predetermined rate for home 
health services, unless CMS determines at the end of the 30-day period 
that the HHA furnished minimal services to a patient during the 30-day 
period.
    (1) For each payment group used to case-mix adjust the 30-day 
payment rate, the 10th percentile value of total visits during a 30-day 
period of care is used to create payment group specific thresholds with 
a minimum threshold of at least 2 visits for each case-mix group.
    (2) A 30-day period with a total number of visits less than the 
threshold is paid the national per-visit amount by discipline 
determined in accordance with Sec.  484.215(a) and updated annually by 
the applicable market basket for each visit type, in accordance with 
Sec.  484.225.
    (3) The national per-visit amount is adjusted by the appropriate 
wage index based on the site of service for the beneficiary.
    (c) An amount is added to low-utilization payment adjustments for 
low-utilization periods that occur as the beneficiary's only 30-day 
period or initial 30-day period in a sequence of adjacent periods of 
care. For purposes of the home health PPS, a sequence of adjacent 
periods of care for a beneficiary is a series of claims with no more 
than 60 days without home care between the end of one period, which is 
the 30th day (except for episodes that have been partial payment 
adjusted), and the beginning of the next episode.

0
14. Section 484.235 is revised to read as follows:


Sec.  [thinsp]484.235  Partial payment adjustments.

    (a) Partial episode payments (PEPs) for episodes beginning on or 
before December 31, 2019. (1) An HHA receives a national, standardized 
60-day payment of a predetermined rate for home health services unless 
CMS determines an intervening event, defined as a beneficiary elected 
transfer or discharge with goals met or no expectation of return to 
home health and the beneficiary returned to home health during the 60-
day episode, warrants a new 60-day episode for purposes of payment. A 
start of care OASIS assessment and physician certification of the new 
plan of care are required.
    (2) The PEP adjustment does not apply in situations of transfers 
among HHAs of common ownership.
    (i) Those situations are considered services provided under 
arrangement on behalf of the originating HHA by the receiving HHA with 
the common

[[Page 56630]]

ownership interest for the balance of the 60-day episode.
    (ii) The common ownership exception to the transfer PEP adjustment 
does not apply if the beneficiary moves to a different MSA or Non-MSA 
during the 60-day episode before the transfer to the receiving HHA.
    (iii) The transferring HHA in situations of common ownership not 
only serves as a billing agent, but must also exercise professional 
responsibility over the arranged-for services in order for services 
provided under arrangements to be paid.
    (3) If the intervening event warrants a new 60-day payment and a 
new physician certification and a new plan of care, the initial HHA 
receives a partial episode payment adjustment reflecting the length of 
time the patient remained under its care based on the first billable 
visit date through and including the last billable visit date. The PEP 
is calculated by determining the actual days served as a proportion of 
60 multiplied by the initial 60-day payment amount.
    (b) Partial payment adjustments for periods beginning on or after 
January 1, 2020. (1) An HHA receives a national, standardized 30-day 
payment of a predetermined rate for home health services unless CMS 
determines an intervening event, defined as a beneficiary elected 
transfer or discharge with goals met or no expectation of return to 
home health and the beneficiary returned to home health during the 30-
day period, warrants a new 30-day period for purposes of payment. A 
start of care OASIS assessment and physician certification of the new 
plan of care are required.
    (2) The partial payment adjustment does not apply in situations of 
transfers among HHAs of common ownership.
    (i) Those situations are considered services provided under 
arrangement on behalf of the originating HHA by the receiving HHA with 
the common ownership interest for the balance of the 30-day period.
    (ii) The common ownership exception to the transfer partial payment 
adjustment does not apply if the beneficiary moves to a different MSA 
or Non-MSA during the 30-day period before the transfer to the 
receiving HHA.
    (iii) The transferring HHA in situations of common ownership not 
only serves as a billing agent, but must also exercise professional 
responsibility over the arranged-for services in order for services 
provided under arrangements to be paid.
    (3) If the intervening event warrants a new 30-day payment and a 
new physician certification and a new plan of care, the initial HHA 
receives a partial payment adjustment reflecting the length of time the 
patient remained under its care based on the first billable visit date 
through and including the last billable visit date. The partial payment 
is calculated by determining the actual days served as a proportion of 
30 multiplied by the initial 30-day payment amount.

0
15. Section 484.240 is revised to read as follows:


Sec.  [thinsp]484.240  Outlier payments.

    (a) For episodes beginning on or before December 31, 2019, an HHA 
receives an outlier payment for an episode whose estimated costs 
exceeds a threshold amount for each case-mix group. The outlier 
threshold for each case-mix group is the episode payment amount for 
that group, or the PEP adjustment amount for the episode, plus a fixed 
dollar loss amount that is the same for all case-mix groups.
    (b) For periods beginning on or after January 1, 2020, an HHA 
receives an outlier payment for a 30-day period whose estimated cost 
exceeds a threshold amount for each case-mix group. The outlier 
threshold for each case-mix group is the 30-day payment amount for that 
group, or the partial payment adjustment amount for the 30-day period, 
plus a fixed dollar loss amount that is the same for all case-mix 
groups.
    (c) The outlier payment is a proportion of the amount of imputed 
cost beyond the threshold.
    (d) CMS imputes the cost for each claim by multiplying the national 
per-15 minute unit amount of each discipline by the number of 15 minute 
units in the discipline and computing the total imputed cost for all 
disciplines.

0
16. Section 484.250 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  484.250  Patient assessment data.

    (a) * * *
    (1) Such 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; and such OASIS data described at Sec.  484.55(b) and (d) as is 
necessary to meet the quality reporting requirements of section 
1895(b)(3)(B)(v) of the Act.
* * * * *

0
17. Section 484.320 is amended by revising paragraph (c) to read as 
follows:


Sec.  484.320  Calculation of the Total Performance Score.

* * * * *
    (c)(1) For performance years 1 through 3, CMS will sum all points 
awarded for each applicable measure excluding the New Measures, 
weighted equally at the individual measure level to calculate a value 
worth 90 percent of the Total Performance Score.
    (2) For performance years 4 and 5, CMS will sum all points awarded 
for each applicable measure within each category of measures (OASIS-
based, claims-based and HHCAHPS) excluding the New Measures, weighted 
at 35 percent for the OASIS-based measure category, 35 percent for the 
claims-based measure category, and 30 percent for the HHCAHPS measure 
category when all three measure categories are reported, to calculate a 
value worth 90 percent of the Total Performance Score.
* * * * *

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

0
18. The authority citation for part 486 is revised to read as follows:

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

0
19. Add reserved subpart H and subpart I to read as follows:

Subpart H--[Reserved]

Subpart I--Requirements for Home Infusion Therapy Suppliers

General Provisions

Sec.
486.500 Basis and scope.
486.505 Definitions.

Standards for Home Infusion Therapy

486.520 Plan of care.
486.525 Required services.

Subpart I--Requirements for Home Infusion Therapy Suppliers

General Provisions


Sec.  486.500  Basis and scope.

    Section 1861(s)(2)(iii) of the Act requires the Secretary to 
establish the conditions that home infusion therapy suppliers must meet 
in order to participate in the Medicare program and which are 
considered necessary to ensure the health and safety of patients.


Sec.  486.505  Definitions.

    As used in Sec. Sec.  486.520 and 486.525:
    Applicable provider means a physician, a nurse provider, and a 
physician assistant.
    Home means a place of residence used as the home of an individual, 
including an institution that is used as a home. An institution that is 
used as a home may not be a hospital, CAH, or

[[Page 56631]]

SNF as defined in section 1861(e)(1), 1861(mm)(1), or 1819(a)(1) of the 
Act, respectively.
    Home infusion drug means a parental 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. The term does not include insulin 
pump systems or a self-administered drug or biological on a self-
administered drug exclusion list.
    Infusion drug administration calendar day means the day on which 
home infusion therapy services are furnished by skilled professionals 
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.
    Qualified home infusion therapy supplier means a supplier of home 
infusion therapy that meets the all of the following criteria which are 
set forth at section 1861(iii)(3)(D)(i) of the Act:
    (1) Furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs.
    (2) Ensures the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
    (3) Is accredited by an organization designated by the Secretary in 
accordance with section 1834(u)(5) of the Act.
    (4) Meets such other requirements as the Secretary determines 
appropriate.

Standards for Home Infusion Therapy


Sec.  486.520  Plan of care.

    The qualified home infusion therapy supplier ensures the following:
    (a) All patients must be under the care of an applicable provider.
    (b) All patients must have a plan of care established by a 
physician that prescribes the type, amount, and duration of the home 
infusion therapy services that are to be furnished.
    (c) The plan of care for each patient must be periodically reviewed 
by the physician.


Sec.  486.525  Required services.

    (a) The qualified home infusion therapy supplier must provide the 
following services on a 7-day-a-week, 24-hour-a-day basis in accordance 
with the plan of care:
    (1) Professional services, including nursing services.
    (2) Patient training and education not otherwise paid for as 
durable medical equipment as described in Sec.  424.57(c)(12) of this 
chapter.
    (3) Remote monitoring and monitoring services for the provision of 
home infusion therapy services and home infusion drugs.
    (b) All home infusion therapy suppliers must provide home infusion 
therapy services in accordance with nationally recognized standards of 
practice, and in accordance with all applicable state and federal laws 
and regulations.

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
20. The authority citation for part 488 is revised to read as follows:

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

0
21. Section 488.5 is amended--
0
a. In paragraph (a)(17)(i) by removing the word ``and'' at the end of 
the paragraph;
0
b. In paragraph (a)(17)(ii) by removing the period and adding in its 
place ``; and''; and
0
c. By adding paragraph (a)(17)(iii).
    The additions read as follows:


Sec.  488.5  Application and re-application procedures for national 
accrediting organizations.

    (a) * * *
    (17) * * *
    (iii) Include a written statement that if a fully accredited and 
deemed facility in good standing provides written notification that 
they wish to voluntarily withdraw from the accrediting organization's 
CMS-approved accreditation program, the accrediting organization must 
continue the facility's current accreditation in full force and effect 
until the effective date of withdrawal identified by the facility or 
the expiration date of the term of accreditation, whichever comes 
first.
* * * * *

0
22. Add reserved subpart K and subpart L to read as follows:

Subpart K--[Reserved]

Subpart L--Accreditation of Home Infusion Therapy Suppliers

General Provisions

Sec.
488.1000 Basis and scope.
488.1005 Definitions.

Approval and Oversight of Home Infusion Therapy Supplier Accrediting 
Organizations

488.1010 Application and reapplication procedures for national home 
infusion therapy accrediting organizations.
488.1015 Resubmitting a request for reapproval.
488.1020 Public notice and comment.
488.1025 Release and use of home infusion therapy accreditation 
surveys.
488.1030 Ongoing review of home infusion therapy accrediting 
organizations.
488.1035 Ongoing responsibilities of a CMS-approved home infusion 
therapy accreditation organization.
488.1040 Onsite observations of home infusion therapy accrediting 
organization operations.
488.1045 Voluntary and involuntary termination.
488.1050 Reconsideration.

Subpart L--Accreditation of Home Infusion Therapy Suppliers

General Provisions


Sec.  488.1000  Basis and scope.

    (a) Regulatory basis for home infusion therapy services. The home 
infusion therapy health and safety regulations are codified at part 
486, subpart I, of this chapter.
    (b) Statutory basis for the accreditation of home infusion therapy 
suppliers. (1) Sections 1102 and 1871 of the Act require that the 
Secretary prescribe such regulations as may be necessary to carry out 
the administration of the Medicare program.
    (2) Section 1834(u)(5) of the Act require the Secretary to 
designate and approve independent organizations for the purposes of 
accrediting qualified home infusion therapy suppliers.
    (c) Scope. This subpart sets forth the following:
    (1) Application and reapplication procedures for national 
accrediting organizations seeking approval or re-approval of authority 
to accredit qualified home infusion therapy suppliers.
    (2) Ongoing CMS oversight processes for approved accrediting 
organizations that accredit qualified home infusion therapy suppliers.
    (3) Appeal procedures for accrediting organizations that accredit 
qualified home infusion therapy suppliers.


Sec.  488.1005  Definitions.

    As used in this subpart--
    Immediate jeopardy means a situation in which the provider's or 
supplier's non-compliance with one or more Medicare accreditation 
requirements has caused, or is likely to cause, serious injury, harm, 
impairment, or death to a patient.
    National accrediting organization means an organization that 
accredits provider or supplier entities under a specific program and 
whose accredited provider or supplier entities under each program are 
widely dispersed geographically across the United States. In addition, 
the specific program is

[[Page 56632]]

active, fully implemented, and operational.
    National in scope means a program is fully implemented, 
operational, and widely dispersed geographically throughout the 
country.
    Qualified home infusion therapy supplier means a supplier of home 
infusion therapy that meets the all of the following criteria which are 
set forth at section 1861(iii)(3)(D)(i) of the Act:
    (1) Furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs.
    (2) Ensures the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
    (3) Is accredited by an organization designated by the Secretary in 
accordance with section 1834(u)(5) of the Act.
    (4) Meets such other requirements as the Secretary determines 
appropriate.
    Reasonable assurance means an accrediting organization has 
demonstrated to CMS' satisfaction that its accreditation program 
requirements meet or exceed the Medicare program requirements.
    Rural area as defined at section 1886(d)(2)(D) of the Act.
    Substantial allegation of non-compliance means a complaint from any 
of a variety of sources (such as patient, relative, or third party), 
including complaints submitted in person, by telephone, through written 
correspondence, or in the newspaper, magazine articles or other media, 
that would, if found to be present, adversely affect the health and 
safety of patients and raises doubts as to a qualified home infusion 
therapy supplier's compliance with the applicable Medicare 
accreditation requirements.

Approval and Oversight of Home Infusion Therapy Supplier Accrediting 
Organizations


Sec.  488.1010  Application and reapplication procedures for national 
home infusion therapy accrediting organizations.

    (a) Information submitted with application. A national home 
infusion therapy accrediting organization applying to CMS for approval 
or re-approval of a designated home infusion therapy accreditation 
program must furnish CMS with information and materials that 
demonstrate that its home infusion therapy accreditation program 
requirements meet or exceed the applicable Medicare requirements for 
accrediting organizations, including the following:
    (1) Documentation that demonstrates the organization meets the 
definition of a national accrediting organization under Sec.  488.1005 
as it relates to the accreditation program.
    (2) The Medicare provider or supplier type for which the 
organization is requesting approval or reapproval.
    (3) Documentation that demonstrates the home infusion therapy 
accrediting organization's ability to take into account the capacities 
of rural home infusion therapy suppliers (as required by section 
1834(u)(5)(A)(ii) of the Act).
    (4) Information that demonstrates the home infusion therapy 
accrediting organization's knowledge, expertise, and experience in home 
infusion therapy.
    (5) A detailed crosswalk (in table format) that identifies, for 
each of the applicable Medicare requirements, the exact language of the 
organization's comparable accreditation requirements and standards.
    (6) A detailed description of the home infusion therapy accrediting 
organization's survey processes to confirm that a home infusion therapy 
supplier's processes are comparable to those of Medicare. This 
description must include all of the following:
    (i) The types and frequency of surveys performed, and a rationale 
for which accreditation requirements will be evaluated via onsite 
surveys and which will be evaluated via offsite audits, or other 
strategies for ensuring accredited home infusion therapy suppliers 
maintain adherence to the home infusion therapy accreditation program 
requirements, including an explanation of how the accrediting 
organization will maintain the schedule it proposes.
    (ii) Copies of the home infusion therapy accrediting organizations 
survey and audit forms, guidelines, and instructions to surveyors.
    (iii) Documentation demonstrating that the home infusion therapy 
accrediting organization's onsite survey or offsite audit reports 
identify, for each finding of non-compliance with accreditation 
standards, the comparable Medicare home infusion therapy accreditation 
requirements, as applicable.
    (iv) A description of the home infusion therapy accrediting 
organization's accreditation survey review process.
    (v) A description of the home infusion therapy accrediting 
organization's procedures and timelines for notifying a surveyed or 
audited home infusion therapy supplier of non-compliance with the home 
infusion therapy accreditation program's standards.
    (vi) A description of the home infusion therapy accrediting 
organization's procedures and timelines for monitoring the home 
infusion therapy supplier's correction of identified non-compliance 
with the accreditation program's standards.
    (vii) The ability of the home infusion therapy accrediting 
organization to conduct timely reviews of accreditation applications.
    (viii) A statement acknowledging that, as a condition for CMS 
approval of a national accrediting organization's accreditation 
program, the home infusion therapy accrediting organization agrees to 
provide CMS with information extracted from each home infusion therapy 
accreditation onsite survey, offsite audit or other evaluation 
strategies as part of its data submissions required under paragraph 
(a)(19) of this section, and, upon request from CMS, a copy of the most 
recent accreditation onsite survey, offsite audit, or other evaluation 
strategy together with any other information related to the survey as 
CMS may require (including corrective action plans).
    (ix) A statement acknowledging that the home infusion therapy 
accrediting organization will provide timely notification to CMS when 
an accreditation survey or complaint investigation identifies an 
immediate jeopardy as that term is defined at Sec.  488.1005. Using the 
format specified by CMS, the home infusion therapy accrediting 
organization must notify CMS within 2 business days from the date the 
accrediting organization identifies the immediate jeopardy.
    (7) Procedures to ensure that--
    (i) Unannounced onsite surveys, as appropriate, will be conducted 
periodically, including procedures that protect against unannounced 
surveys becoming known to the provider or supplier in advance of the 
visit; or
    (ii) Offsite survey audits are performed to evaluate the quality of 
services provided which may be followed up with periodic onsite visits.
    (8) The criteria for determining the size and composition of the 
home infusion therapy accrediting organization's survey, audit and 
other evaluation strategy teams for individual supplier onsite surveys. 
The home infusion therapy accrediting organization's criteria should 
include, but not be limited to the following information:
    (i) The expected number of individual home infusion therapy 
supplier locations to be surveyed using an onsite survey.
    (ii) The number of home infusion therapy suppliers to be surveyed 
using off-site audits.

[[Page 56633]]

    (iii) A description of other types of home infusion therapy 
accreditation review activities to be used.
    (iv) The reasons for each type of survey (that is, initial 
accreditation survey, reaccreditation survey, and complaint survey).
    (9) The overall adequacy of the number of the home infusion therapy 
accrediting organization's surveyors, auditors, and other staff 
available to perform survey related activities, including how the 
organization will increase the size of the survey, audit, and other 
evaluation staff to match growth in the number of accredited facilities 
or programs while maintaining re-accreditation intervals for existing 
accredited facilities or programs.
    (10) Detailed information about the individuals who perform onsite 
surveys, offsite audits or other strategies for ensuring accredited 
home infusion therapy suppliers maintain adherence to the home infusion 
therapy accreditation program requirements, including all of the 
following information:
    (i) The number and types of professional and technical staff 
available for conducting onsite surveys, offsite audits, or other 
strategies for ensuring accredited home infusion therapy suppliers 
maintain adherence to the home infusion therapy accreditation program 
requirements.
    (ii) The education, employment, and experience requirements 
surveyors and auditors must meet.
    (iii) The content and length of the orientation program.
    (11) The content, frequency and types of in-service training 
provided to survey and audit personnel.
    (12) The evaluation systems used to monitor the performance of 
individual surveyors, auditors and survey teams.
    (13) The home infusion therapy accrediting organization's policies 
and procedures to avoid conflicts of interest, including the appearance 
of conflicts of interest, involving individuals who conduct surveys, 
audits or participate in accreditation decisions.
    (14) The policies and procedures used when a home infusion therapy 
supplier has a dispute regarding survey or audit findings, or an 
adverse decision.
    (15) Procedures for the home infusion therapy supplier to use to 
notify the home infusion therapy accrediting organization when the 
accredited home infusion therapy supplier does the either of the 
following:
    (i) Removes or ceases furnishing services for which they are 
accredited.
    (ii) Adds services for which they are not accredited.
    (16) The home infusion therapy accrediting organization's 
procedures for responding to, and investigating complaints against 
accredited facilities, including policies and procedures regarding 
referrals, when applicable, to appropriate licensing bodies, ombudsmen 
offices, and CMS.
    (17) A description of the home infusion therapy accrediting 
organization's accreditation status decision-making process. The home 
infusion therapy accrediting organization must furnish the following:
    (i) Its process for addressing deficiencies identified with 
accreditation program requirements, and the procedures used to monitor 
the correction of deficiencies identified during an accreditation 
survey and audit process.
    (ii) A description of all types and categories of accreditation 
decisions associated with the program, including the duration of each 
of the organization's accreditation decisions.
    (iii) Its policies and procedures for the granting, withholding or 
removal of accreditation status for facilities that fail to meet the 
accrediting organization's standards or requirements, assignment of 
less than full accreditation status or other actions taken by the 
organization in response to non-compliance with its standards and 
requirements.
    (iv) A statement acknowledging that the home infusion therapy 
accrediting organization agrees to notify CMS (in a manner CMS 
specifies) of any decision to revoke, terminate, or revise the 
accreditation status of a home infusion therapy supplier, within 3 
business days from the date the organization takes an action.
    (18) A list of all currently accredited home infusion therapy 
suppliers, the type and category of accreditation, currently held by 
each, and the expiration date for each home infusion therapy supplier's 
current accreditation.
    (19) A schedule of all survey activity (such as onsite surveys, 
offsite audits and other types if survey strategies) expected to be 
conducted by the organization during the 6-month period following 
submission of an initial or renewal application.
    (20) A written presentation that demonstrates the organization's 
ability to furnish CMS with electronic data.
    (21) A description of the home infusion therapy accrediting 
organization's data management and analysis system with respect to its 
surveys and accreditation decisions, including all of the following:
    (i) A detailed description of how the home infusion therapy 
accrediting organization uses its data to assure the compliance of its 
home infusion therapy accreditation program with the Medicare home 
infusion therapy accreditation program requirements.
    (ii) A written statement acknowledging that the home infusion 
therapy accrediting organization agrees to submit timely, accurate, and 
complete data that CMS has determined is both necessary to evaluate the 
accrediting organization's performance and is not unduly burdensome for 
the accrediting organization to submit.
    (A) The organization must submit necessary data according to the 
instructions and timeframes CMS specifies.
    (B) Data to be submitted includes the following:
    (1) Accredited home infusion therapy supplier identifying 
information.
    (2) Survey findings.
    (3) Quality measures.
    (4) Notices of accreditation decisions.
    (22) The three most recent annual audited financial statements of 
the home infusion therapy accrediting organization that demonstrate 
that the organization's staffing, funding, and other resources are 
adequate to perform the required surveys, audits, and related 
activities to maintain the accreditation program.
    (23) A written statement acknowledging that, as a condition for 
approval, the home infusion therapy accrediting organization agrees to 
the following:
    (i) Voluntary termination. Provide written notification to CMS and 
all home infusion therapy suppliers accredited under its CMS-approved 
home infusion therapy accreditation program at least 180 calendar days 
in advance of the effective date of a decision by the home infusion 
therapy accrediting organization to voluntarily terminate its CMS-
approved home infusion therapy accreditation program and the 
implications for the suppliers' payment status once their current term 
of accreditation expires in accordance with the requirements at Sec.  
488.1045(a).
    (ii) Involuntary termination. Provide written notification to all 
accredited home infusion therapy suppliers accredited under its CMS-
approved home infusion therapy accreditation program no later than 30 
calendar days after the notice is published in the Federal Register 
announcing that CMS is withdrawing its approval of its accreditation 
program and the implications for the home infusion therapy supplier's 
payment status in accordance with the requirements at Sec.  488.1045(b) 
once their current term of accreditation expires.
    (A) For both voluntary and involuntary terminations, provide a 
second written notification to all

[[Page 56634]]

accredited home infusion therapy suppliers 10 calendar days prior to 
the organization's accreditation program effective date of termination.
    (B) Notify CMS, in writing (electronically or hard copy), within 2 
business days of a deficiency identified in any accredited home 
infusion therapy supplier from any source where the deficiency poses an 
immediate jeopardy to the home infusion therapy supplier's 
beneficiaries or a hazard to the general public.
    (iii) Summary accreditation activity data and trends. Provide, on 
an annual basis, summary accreditation activity data and trends 
including the following:
    (A) Deficiencies.
    (B) Complaints.
    (C) Terminations.
    (D) Withdrawals.
    (E) Denials.
    (F) Accreditation decisions.
    (G) Other survey-related activities as specified by CMS.
    (iv) Termination of an accreditation organization. If CMS 
terminates a home infusion therapy accrediting organization's approved 
status, the home infusion therapy accrediting organization must work 
collaboratively with CMS to direct its accredited home infusion therapy 
suppliers to the remaining CMS-approved accrediting organizations 
within a reasonable period of time.
    (v) Notification of proposed changes. Notify CMS at least 60 days 
in advance of the implementation date of any significant proposed 
changes in its CMS-approved home infusion therapy accreditation program 
and that it agrees not to implement the proposed changes without prior 
written notice of continued program approval from CMS, except as 
provided for at Sec.  488.1040(b)(2).
    (vi) Response to a written notice from CMS. A statement 
acknowledging that, in response to a written notice from CMS to the 
home infusion therapy accrediting organization of a change in the 
applicable home infusion therapy accreditation requirements or survey 
process, the organization will provide CMS with proposed corresponding 
changes in the accrediting organization's home infusion therapy 
accreditation requirements for its CMS-approved home infusion therapy 
accreditation program to ensure that its accreditation standards 
continue to meet or exceed those of Medicare, or survey process remains 
comparable with that of Medicare. The home infusion therapy accrediting 
organization must comply with the following requirements:
    (A) The proposed changes must be submitted within 30 calendar days 
of the date of the written CMS notice to the home infusion therapy 
accrediting organization or by a date specified in the notice, 
whichever is later. CMS gives due consideration to a home infusion 
therapy accrediting organization's request for an extension of the 
deadline as long as it is submitted prior to the due date.
    (B) The proposed changes are not to be implemented without prior 
written notice of continued program approval from CMS, except as 
provided for at Sec.  488.1040(b)(2)(ii).
    (24) The organization's proposed fees for accreditation, including 
any plans for reducing the burden and cost of accreditation to small 
and rural suppliers.
    (b) Additional information needed. If CMS determines that 
additional information is necessary to make a determination for 
approval or denial of the home infusion therapy accrediting 
organization's initial application or re-application for CMS-approval 
of an accreditation program, CMS requires that the home infusion 
therapy accrediting organization s submit any specific documentation 
requirements and attestations as a condition of approval of 
accreditation status. CMS notifies the home infusion therapy 
accrediting organization and afford it an opportunity to provide the 
additional information.
    (c) Withdrawing an application. A home infusion therapy accrediting 
organization may withdraw its initial application for CMS' approval of 
its home infusion therapy accreditation program at any time before CMS 
publishes the final notice described in Sec.  488.1025(b).
    (d) Notice of approval or disapproval of application. CMS sends a 
notice of its decision to approve or disapprove the home infusion 
therapy accrediting organization's application within 210 calendar days 
from the date CMS determines the home infusion therapy accrediting 
organization's application is complete. The final notice specifies the 
following:
    (1) The basis for the decision.
    (2) The effective date.
    (3) The term of the approval (not exceed 6 years).


Sec.  488.1015  Resubmitting a request for reapproval.

    (a) Except as provided in paragraph (b) of this section, a home 
infusion therapy accrediting organization whose request for CMS's 
approval or re-approval of an accreditation program has been denied, or 
a home infusion therapy accrediting organization that has voluntarily 
withdrawn an initial application, may resubmit its application if the 
home infusion therapy accrediting organization satisfies all of the 
following requirements:
    (1) Revises its home infusion therapy accreditation program to 
address the issues related to the denial of its previous request or its 
voluntary withdrawal.
    (2) Resubmits the application in its entirety.
    (b) If a home infusion therapy accrediting organization has 
requested, in accordance with Sec.  488.1050, a reconsideration of 
CMS's disapproval, it may not submit a new application for approval of 
a home infusion therapy accreditation program until such 
reconsideration is administratively final.


Sec.  488.1020  Public notice and comment.

    CMS publishes a notice in the Federal Register when the following 
conditions are met:
    (a) Proposed notice. CMS publishes a notice after the receipt of a 
completed application from a national home infusion therapy accrediting 
organization seeking CMS's approval of a home infusion therapy 
accreditation program. The notice identifies the home infusion therapy 
accrediting organization, the type of suppliers covered by the home 
infusion therapy accreditation program, and provides at least a 30 day 
public comment period (beginning on the date of publication).
    (b) Final notice. The final notice announces CMS decision to 
approve or deny a national accrediting organization application. The 
notice specifies the basis for the CMS decision.
    (1) Approval or re-approval. If CMS approves or re-approves the 
home infusion therapy accrediting organization's home infusion therapy 
accreditation program, the final notice at a minimum includes the 
following information:
    (i) A description of how the home infusion therapy accreditation 
program meets or exceeds Medicare home infusion therapy accreditation 
program requirements.
    (ii) The effective date of approval (no later than the publication 
date of the notice).
    (iii) The term of the approval (6 years or less).
    (2) Denial. If CMS does not approve the home infusion therapy 
accrediting organization's accreditation program, the final notice 
describes the following:
    (i) How the home infusion therapy accrediting organization fails to 
meet

[[Page 56635]]

Medicare home infusion therapy accreditation program requirements.
    (ii) The effective date of the decision.


Sec.  488.1025  Release and use of home infusion therapy accreditation 
surveys.

    The home infusion therapy accrediting organization must include, in 
its accreditation agreement with each supplier, an acknowledgement that 
the supplier agrees to release to CMS a copy of its most current 
accreditation survey and any information related to the survey that CMS 
may require, corrective action plans.
    (a) CMS may determine that a home infusion therapy supplier does 
not meet the applicable Medicare conditions or requirements on the 
basis of its own investigation of the accreditation survey or any other 
information related to the survey.
    (b) With the exception of home health agency surveys, general 
disclosure of an accrediting organization's survey information is 
prohibited under section 1865(b) of the Act. CMS may publically 
disclose an accreditation survey and information related to the survey, 
upon written request, to the extent that the accreditation survey and 
survey information are related to an enforcement action taken by CMS.


Sec.  488.1030  Ongoing review of home infusion therapy accrediting 
organizations.

    (a) Performance review. CMS evaluates the performance of each CMS-
approved home infusion therapy accreditation program on an ongoing 
basis. This review includes the review of the following:
    (1) The home infusion therapy accrediting organization's survey 
activity.
    (2) The home infusion therapy accrediting organization's continued 
fulfillment of the requirements at Sec. Sec.  488.1010 and 488.1035.
    (b) Comparability review. CMS assesses the equivalency of a home 
infusion therapy accrediting organization's CMS-approved program 
requirements with the comparable Medicare home infusion therapy 
accreditation requirements after CMS imposes new or revised Medicare 
accreditation requirements. When this occurs, the following takes 
place:
    (1) CMS provides the home infusion therapy accrediting 
organizations with written notice of the changes to the to the Medicare 
home infusion therapy accreditation requirements.
    (2) The home infusion therapy accrediting organization must make 
revisions to its home infusion therapy accreditation standards or 
survey processes which incorporate the new or revised Medicare 
accreditation requirements.
    (3) In the written notice, CMS specifies the deadline (no less than 
30 calendar days) by which the home infusion therapy accrediting 
organization must submit its proposed revised home infusion therapy 
accreditation standard or survey process revisions, and the 
timeframe(s) for implementation of these revised home infusion therapy 
accreditation standards.
    (4) CMS may extend the submission deadline by which the accrediting 
organization must submit its proposed revised home infusion therapy 
accreditation standards and survey processes, if both of the following 
occur:
    (i) The accrediting organization submits a written request for an 
extension of the submission deadline.
    (ii) The request for extension is submitted prior to the original 
submission deadline.
    (5) After completing the comparability review of the home infusion 
therapy accrediting organizations revised home infusion therapy 
accreditation standards and survey processes, CMS shall provide written 
notification to the home infusion therapy accrediting organization 
regarding whether or not its home infusion therapy accreditation 
program, including the proposed revised home infusion therapy 
accreditation standards and implementation timeframe(s), continues to 
meet or exceed all applicable Medicare requirements.
    (6) If, no later than 60 calendar days after receipt of the home 
infusion therapy accrediting organization's proposed changes, CMS does 
not provide the written notice to the home infusion therapy accrediting 
organization required, then the revised home infusion therapy 
accreditation standards and program is deemed to meet or exceed all 
applicable Medicare requirements and to have continued CMS-approval.
    (7) If a home infusion therapy accrediting organization is required 
to submit a new application because CMS imposes new home infusion 
therapy regulations or makes significant substantive revisions to the 
existing home infusion therapy regulations, CMS provides notice of the 
decision to approve or disapprove the new application submitted by the 
home infusion therapy accrediting organization within the time period 
specified in Sec.  488.1010(d).
    (8) If a home infusion therapy accrediting organization fails to 
submit its proposed changes to its home infusion therapy accreditation 
standards and survey processes within the required timeframe, or fails 
to implement the proposed changes that have been determined or deemed 
by CMS to be comparable, CMS may open an accreditation program review 
in accordance with paragraph (d) of this section.
    (c) Review of revised home infusion therapy accreditation standards 
submitted to CMS by an accrediting organization. When a home infusion 
therapy accrediting organization proposes to adopt new or revised 
accreditation standards, requirements or changes in its survey process, 
the home infusion therapy accrediting organization must do the 
following:
    (1) Provide CMS with written notice of any proposed changes in home 
infusion therapy accreditation standards, requirements or survey 
process at least 60 days prior to the proposed implementation date of 
the proposed changes.
    (2) Not implement any of the proposed changes before receiving 
CMS's approval, except as provided in paragraph (c)(4) of this section.
    (3) Provide written notice to CMS that includes all of the 
following:
    (i) A detailed description of the changes that are to be made to 
the organization's home infusion therapy accreditation standards, 
requirements and survey processes.
    (ii) A detailed crosswalk (in table format) that states the exact 
language of the organization's revised accreditation requirements and 
the applicable Medicare requirements for each.
    (4) CMS must provide a written notice to the home infusion therapy 
accrediting organization which states whether the home infusion therapy 
accreditation program, including the proposed revisions, continues or 
does not continue to meet or exceed all applicable Medicare home 
infusion therapy requirements within 60 days of receipt of the home 
infusion therapy accrediting organization's proposed changes. If CMS 
has made a finding that the home infusion therapy accrediting 
organization's home infusion therapy accreditation program, 
accreditation requirements and survey processes, including the proposed 
revisions does not continue to meet or exceed all applicable Medicare 
home infusion therapy requirements. CMS must state the reasons for 
these findings.
    (5) If, no later than 60 calendar days after receipt of the home 
infusion therapy accrediting organization's proposed changes, CMS does 
not provide written notice to the home infusion therapy accrediting 
organization that the home infusion

[[Page 56636]]

therapy accreditation program, including the proposed revisions, 
continues or does not continue to meet or exceed all applicable 
Medicare home infusion therapy requirements, then the revised home 
infusion therapy accreditation program is deemed to meet or exceed all 
applicable Medicare home infusion therapy requirements and to have 
continued CMS approval.
    (6) If a home infusion therapy accrediting organization implements 
changes that have neither been determined nor deemed by CMS to be 
comparable to the applicable Medicare home infusion therapy 
requirements, CMS may open a home infusion therapy accreditation 
program review in accordance with paragraph (d) of this section.
    (d) CMS-approved home infusion therapy accreditation program 
review. If a comparability, performance, or standards review reveals 
evidence of substantial non-compliance of a home infusion therapy 
accrediting organization's CMS-approved home infusion therapy 
accreditation program with the requirements of this subpart, CMS may 
initiate a home infusion therapy accreditation program review.
    (1) If a home infusion therapy accreditation program review is 
initiated, CMS will provide written notice to the home infusion therapy 
accrediting organization indicating that its CMS-approved accreditation 
program approval may be in jeopardy and that a home infusion therapy 
accreditation program review is being initiated. The notice will 
provide all of the following information:
    (i) A statement of the instances, rates or patterns of non-
compliance identified, as well as other related information, if 
applicable.
    (ii) A description of the process to be followed during the review, 
including a description of the opportunities for the home infusion 
therapy accrediting organization to offer factual information related 
to CMS' findings.
    (iii) A description of the possible actions that may be imposed by 
CMS based on the findings of the home infusion therapy accreditation 
program review.
    (iv) The actions the home infusion therapy accrediting organization 
must take to address the identified deficiencies
    (v) The length of the accreditation program review probation 
period, which will include monitoring of the home infusion therapy 
accrediting organization's performance and implementation of the 
corrective action plan. The probation period is not to exceed 180 
calendar days from the date that CMS approves the AOs corrective action 
plan.
    (2) CMS will review and approve the home infusion therapy 
accrediting organization's plan of correction for acceptability within 
30 days after receipt.
    (3) CMS will monitor the AO's performance and implementation of the 
plan of correction during the probation period which is not to exceed 
180 days from the date of approval of the plan of correction.
    (4) If CMS determines, as a result of the home infusion therapy 
accreditation program review or a review of an application for renewal 
of the accrediting organizations existing CMS-approved home infusion 
therapy accreditation program, that the home infusion therapy 
accrediting organization has failed to meet any of the requirements of 
this subpart, CMS may place the home infusion therapy accrediting 
organization's CMS-approved home infusion therapy accreditation program 
on an additional probation period of up to 180 calendar days subsequent 
to the 180-day probation period described in paragraph (d)(1)(v) of 
this section to implement additional corrective actions or demonstrate 
sustained compliance, not to exceed the home infusion therapy 
accrediting organization's current term of approval. In the case of a 
renewal application where CMS has already placed the home infusion 
therapy accreditation program on probation, CMS indicates that any 
approval of the application is conditional while the program is placed 
on probation.
    (i) Within 60 calendar days after the end of any probationary 
period, CMS issues a written determination to the home infusion therapy 
accrediting organization as to whether or not its CMS-approved home 
infusion therapy accreditation program continues to meet the 
requirements of this subpart, including the reasons for the 
determination.
    (ii) If CMS determines that the home infusion therapy accrediting 
organization does not meet the requirements, CMS may withdraw approval 
of the CMS-approved home infusion therapy accreditation program. The 
notice of determination provided to the home infusion therapy 
accrediting organization includes notice of the removal of approval, 
reason for the removal, including the effective date determined in 
accordance with paragraph (d)(4)(iii) of this section.
    (iii) CMS publishes in the Federal Register a notice of its 
decision to withdraw approval of a CMS-approved accreditation program, 
including the reasons for the withdrawal, effective 60 calendar days 
after the date of publication of the notice.
    (e) Immediate jeopardy. If at any time CMS determines that the 
continued approval of a CMS-approved home infusion therapy 
accreditation program of any home infusion therapy accrediting 
organization poses an immediate jeopardy to the patients of the 
suppliers accredited under the program, or the continued approval 
otherwise constitutes a significant hazard to the public health, CMS 
may immediately withdraw the approval of a CMS-approved home infusion 
therapy accreditation program of that home infusion therapy accrediting 
organization and publish a notice of the removal, including the reasons 
for it, in the Federal Register.
    (f) Notification to home infusion therapy suppliers of withdrawal 
of CMS approval status. A home infusion therapy accrediting 
organization whose CMS approval of its home infusion therapy 
accreditation program has been withdrawn must notify each of its 
accredited home infusion therapy suppliers, in writing, of the 
withdrawal of CMS approval status no later than 30 calendar days after 
the notice is published in the Federal Register. The notification to 
the accredited home infusion therapy suppliers must inform them of the 
implications for their payment status once their current term of 
accreditation expires.


Sec.  488.1035  Ongoing responsibilities of a CMS-approved home 
infusion therapy accrediting organization.

    A home infusion therapy accreditation organization approved by CMS 
must carry out the following activities on an ongoing basis:
    (a) Provide CMS with all of the following in written format (either 
electronic or hard copy):
    (1) Copies of all home infusion therapy accreditation surveys, 
together with any survey-related information that CMS may require 
(including corrective action plans and summaries of findings with 
respect to unmet CMS requirements).
    (2) Notice of all accreditation decisions.
    (3) Notice of all complaints related to providers or suppliers.
    (4) Information about all home infusion therapy accredited 
suppliers against which the home infusion therapy accreditation 
organization has taken remedial or adverse action, including 
revocation, withdrawal, or revision of the providers or suppliers 
accreditation.

[[Page 56637]]

    (5) The home infusion therapy accrediting organization must 
provide, on an annual basis, summary data specified by CMS that relate 
to the past year's accreditation activities and trends.
    (6) Notice of any proposed changes in the home infusion therapy 
accrediting organization's accreditation standards or requirements or 
survey process. If the home infusion therapy accrediting organization 
implements the changes before or without CMS' approval, CMS may 
withdraw its approval of the accrediting organization.
    (b) Within 30 calendar days after a change in CMS requirements, the 
home infusion therapy accrediting organization must submit an 
acknowledgment of receipt of CMS' notification to CMS.
    (c) The home infusion therapy accrediting organization must permit 
its surveyors to serve as witnesses if CMS takes an adverse action 
based on accreditation findings.
    (d) Within 2 business days of identifying a deficiency of an 
accredited home infusion therapy supplier that poses immediate jeopardy 
to a beneficiary or to the general public, the home infusion therapy 
accrediting organization must provide CMS with written notice of the 
deficiency and any adverse action implemented by the accrediting 
organization.
    (e) Within 10 calendar days after CMS' notice to a CMS-approved 
home infusion therapy accrediting organization that CMS intends to 
withdraw approval of the home infusion therapy accrediting 
organization, the home infusion therapy accrediting organization must 
provide written notice of the withdrawal to all of the home infusion 
therapy accrediting organization's accredited suppliers.


Sec.  488.1040  Onsite observations of home infusion therapy 
accrediting organization operations.

    (a) As part of the application review process, the ongoing review 
process, or the continuing oversight of a home infusion therapy 
accrediting organization's performance, CMS may conduct onsite 
inspections of the home infusion therapy accrediting organization's 
operations and offices at any time to verify the home infusion therapy 
accrediting organization's representations and to assess the home 
infusion therapy accrediting organization's compliance with its own 
policies and procedures.
    (b) Activities to be performed by CMS staff during the onsite 
inspections may include, but are not limited to the following:
    (1) Interviews with various accrediting organization staff.
    (2) Review of documents, survey files, audit tools, and related 
records.
    (3) Observation of meetings concerning the home infusion therapy 
accreditation process.
    (4) Auditing meetings concerning the accreditation process.
    (5) Observation of in-progress surveys and audits.
    (6) Evaluation of the accrediting organization's survey results and 
accreditation decision-making process.


Sec.  488.1045  Voluntary and involuntary termination.

    (a) Voluntary termination by a CMS-approved accrediting program. In 
accordance with Sec.  488.1010(a)(23), a home infusion therapy 
accrediting organization that decides to voluntarily terminate its CMS-
approved home infusion therapy accreditation program must provide 
written notice at least 180 days in advance of the effective date of 
the termination to CMS and each of its accredited home infusion therapy 
suppliers.
    (b) Involuntary termination of an accrediting organization's 
approval by CMS. Once CMS publishes the notice in the Federal Register 
announcing its decision terminate the home infusion therapy accrediting 
organization's home infusion therapy accreditation program, the home 
infusion therapy accrediting organization must provide written 
notification to all suppliers accredited under its CMS-approved home 
infusion therapy accreditation program no later than 30 calendar days 
after the notice is published in the Federal Register announcing that 
CMS is withdrawing its approval of its home infusion therapy 
accreditation program and the implications for the home infusion 
therapy suppliers payment status in accordance with the requirements at 
Sec.  488.1010(f) once their current term of accreditation expires.
    (c) Voluntary and involuntary terminations. For both voluntary and 
involuntary terminations--
    (1) The accreditation status of affected home infusion therapy 
suppliers is considered to remain in effect until their current term of 
accreditation expires;
    (2) If the home infusion therapy supplier wishes to avoid a 
suspension of payment, it must provide written notice to CMS at least 
60-calendar days prior to its accreditation expiration date that it has 
submitted an application for home infusion therapy accreditation under 
another CMS-approved home infusion therapy accreditation program. 
Failure to comply with this 60-calendar day requirement prior to 
expiration of their current home infusion therapy accreditation 
stations within could result in a suspension of payment; and
    (3) The home infusion therapy accrediting organization provides a 
second written notification to all accredited home infusion therapy 
suppliers ten calendar days prior to the organization's accreditation 
program effective date of termination.
    (d) Voluntary withdrawal from accreditation requested by a home 
infusion therapy supplier. If a voluntary withdrawal from accreditation 
is requested by the home infusion therapy supplier, the withdrawal may 
not become effective until the accrediting organization completes all 
of the following steps:
    (1) The accrediting organization must contact the home infusion 
therapy supplier to seek written confirmation that the home infusion 
therapy supplier intends to voluntarily withdraw from the home infusion 
therapy accreditation program.
    (2) The home infusion therapy accrediting organization must advise 
the home infusion therapy supplier, in writing, of the statutory 
requirement for accreditation for all home infusion therapy suppliers 
and the possible payment consequences for a lapse in accreditation 
status.
    (3) The home infusion therapy accrediting organization must submit 
their final notice of the voluntary withdrawal of accreditation by the 
home infusion therapy supplier to CMS by 5 business days after the 
request for voluntary withdrawal is ultimately processed and effective.


Sec.  488.1050  Reconsideration.

    (a) General rule. A home infusion therapy accrediting organization 
dissatisfied with a determination that its home infusion therapy 
accreditation requirements do not provide or do not continue to provide 
reasonable assurance that the suppliers accredited by the home infusion 
therapy accrediting organization meet the applicable quality standards 
is entitled to reconsideration.
    (b) Filing requirements. (1) A written request for reconsideration 
must be filed within 30 calendar days of the receipt of CMS notice of 
an adverse determination or non-renewal.
    (2) The written request for reconsideration must specify the 
findings or issues with which the home infusion therapy accrediting 
organization disagrees and the reasons for the disagreement.
    (3) A requestor may withdraw its written request for 
reconsideration at

[[Page 56638]]

any time before the issuance of a reconsideration determination.
    (c) CMS response to a request for reconsideration. In response to a 
request for reconsideration, CMS provides the accrediting organization 
with--
    (1) The opportunity for a hearing to be conducted by a hearing 
officer appointed by the Administrator of CMS and provide the 
accrediting organization the opportunity to present, in writing and in 
person, evidence or documentation to refute the determination to deny 
approval, or to withdraw or not renew designation; and
    (2) Written notice of the time and place of the hearing at least 10 
business days before the scheduled date.
    (d) Hearing requirements and rules. (1) The reconsideration hearing 
is a public hearing open to all of the following:
    (i) Authorized representatives and staff from CMS, including, but 
not limited to, the following:
    (A) Technical advisors (individuals with knowledge of the facts of 
the case or presenting interpretation of the facts).
    (B) Legal counsel.
    (C) Non-technical witnesses with personal knowledge of the facts of 
the case.
    (ii) Representatives from the accrediting organization requesting 
the reconsideration including, but not limited to, the following:
    (A) Authorized representatives and staff from the accrediting 
organization.
    (B) Technical advisors (individuals with knowledge of the facts of 
the case or presenting interpretation of the facts).
    (C) Legal counsel.
    (D) Non-technical witnesses, such as patients and family members 
that have personal knowledge of the facts of the case.
    (2) The hearing is conducted by the hearing officer who receives 
testimony and documents related to the proposed action.
    (3) Testimony and other evidence may be accepted by the hearing 
officer even though such evidence may be inadmissible under the Federal 
Rules of Civil Procedure.
    (4) The hearing officer does not have the authority to compel by 
subpoena the production of witnesses, papers, or other evidence.
    (5) Within 45 calendar days after the close of the hearing, the 
hearing officer will present the findings and recommendations to the 
accrediting organization that requested the reconsideration.
    (6) The written report of the hearing officer will include separate 
numbered findings of fact and the legal conclusions of the hearing 
officer.
    (7) The hearing officer's decision is final.

    Dated: October 19, 2018.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.
    Dated: October 22, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-24145 Filed 10-31-18; 4:15 pm]
 BILLING CODE 4120-01-P