[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Rules and Regulations]
[Pages 70298-70356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24146]



[[Page 70297]]

Vol. 85

Wednesday,

No. 214

November 4, 2020

Part III





Department of Health and Human Services





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 Centers for Medicare & Medicaid Services





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42 CFR Parts 409, 410, et al.





Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment 
System Rate Update, Home Health Quality Reporting Program Requirements, 
and Home Infusion Therapy Services and Supplier Enrollment 
Requirements; and Home Health Value-Based Purchasing Model Data 
Submission Requirements; Final Rule

  Federal Register / Vol. 85 , No. 214 / Wednesday, November 4, 2020 / 
Rules and Regulations  

[[Page 70298]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 410, 414, 424, and 484

[CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC]
RIN 0938-AU06, 0938-AU31, and 0938-AU32


Medicare and Medicaid Programs; CY 2021 Home Health Prospective 
Payment System Rate Update, Home Health Quality Reporting Program 
Requirements, and Home Infusion Therapy Services and Supplier 
Enrollment Requirements; and Home Health Value-Based Purchasing Model 
Data Submission Requirements

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

ACTION: Final rule.

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SUMMARY: This final rule updates the home health prospective payment 
system (HH PPS) payment rates and wage index for calendar year (CY) 
2021. This final rule also implements the changes to the home health 
regulations regarding the use of telecommunications technology in 
providing services under the Medicare home health benefit as described 
in the ``Medicare and Medicaid Programs, Policy and Regulatory 
Revisions in Response to the COVID-19 Public Health Emergency'' interim 
final rule with comment period (March 2020 COVID-19 IFC). In addition, 
this rule implements the permanent home infusion therapy services 
benefit and supplier enrollment requirements for CY 2021 and finalizes 
conforming regulations text changes excluding home infusion therapy 
services from coverage under the Medicare home health benefit. This 
rule also finalizes a policy to align the Home Health Value-Based 
Purchasing (HHVBP) Model data submission requirements with any 
exceptions or extensions granted for purposes of the Home Health 
Quality Reporting Program (HH QRP) during the COVID-19 PHE and also 
finalizes a policy for granting exceptions to the New Measures data 
reporting requirements during the COVID-19 PHE, as described in the 
``Medicare and Medicaid Programs, Basic Health Program, and Exchanges; 
Additional Policy and Regulatory Revisions in Response to the COVID-19 
Public Health Emergency and Delay of Certain Reporting Requirements for 
the Skilled Nursing Facility Quality Reporting Program'' interim final 
rule with comment period (May 2020 COVID-19 IFC).

DATES: These regulations are effective on January 1, 2021.

FOR FURTHER INFORMATION CONTACT: Brian Slater (410) 786-5229, for home 
health and home infusion therapy payment inquiries.
    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 Quality Reporting Program (HH 
QRP), send your inquiry via email to [email protected].
    Mary Rossi-Coajou, (410) 786-6051, for condition of participation 
(CoP) OASIS requirements.
    For information about the Home Health Value Based Model, send your 
inquiry via email to [email protected].
    Joseph Schultz, (410) 786-2656, for information about home infusion 
therapy supplier enrollment requirements.

SUPPLEMENTARY INFORMATION: Wage index addenda will be available only 
through the CMS Coding and Billing Information website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/coding_billing.

I. Executive Summary

A. Purpose

1. Home Health Prospective Payment System (HH PPS)
    This final rule updates the payment rates for home health agencies 
(HHAs) for calendar year (CY) 2021, as required under section 1895(b) 
of the Social Security Act (the Act). This rule sets forth the case-mix 
weights under section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for 30-
day periods of care in CY 2021; the CY 2021 fixed-dollar loss ratio 
(FDL); and the loss-sharing ratio for outlier payments (as required by 
section 1895(b)(5)(A) of the Act). Additionally, this rule adopts the 
revised Office of Management and Budget (OMB) statistical area 
delineations as described in the September 14, 2018 OMB Bulletin No. 
18-04 \1\ for the labor market delineations used in the home health 
wage index, effective beginning in CY 2021. This rule finalizes a cap 
on wage index decreases in excess of 5 percent and adopts the OMB 
statistical areas and the 5-percent cap on wage index decreases under 
the statutory discretion afforded to the Secretary under sections 
1895(b)(4)(A)(ii) and (b)(4)(C) of the Act. Lastly, this rule finalizes 
the changes to Sec.  409.43(a) as set forth in the interim final rule 
with comment period that appeared in the April 6, 2020 Federal Register 
titled ``Medicare and Medicaid Programs; Policy and Regulatory 
Revisions in Response to the COVID-19 Public Health Emergency'' (PHE) 
(March 2020 COVID-19 IFC), to state that the plan of care must include 
any provision of remote patient monitoring or other services furnished 
via a telecommunications system (85 FR 19230).
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    \1\ On March 6, 2020, OMB issued the most recent OMB Bulletin 
No. 20-01.
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2. Home Health Quality Reporting Program (HH QRP)
    We did not propose any changes for the HH QRP and therefore are not 
finalizing any policies in this final rule.
3. Changes to the Conditions of Participation (CoPs) OASIS Requirements
    This final rule removes an obsolete provision that requires new 
HHAs that do not yet have a CMS certification number to conduct test 
OASIS data transmissions to the CMS data system as part of the initial 
certification process.
4. Reporting Under the Home Health Value Based Purchasing (HHVBP) Model 
During the COVID-19 PHE
    This rule finalizes a policy to align HHVBP Model data submission 
requirements with any exceptions or extensions granted for purposes of 
the HH QRP as well as a policy for granting exceptions to the New 
Measures data reporting requirements during the COVID-19 PHE, as 
described in the interim final rule with comment period that appeared 
in the May 8, 2020 Federal Register titled ``Medicare and Medicaid 
Programs; Basic Health Program, and Exchanges; Additional Policy and 
Regulatory Revisions in Response to the COVID-19 Public Health 
Emergency and Delay of Certain Reporting Requirements for the Skilled 
Nursing Facility Quality Reporting Program'' (85 FR 27553) (May 2020 
COVID-19 IFC).
5. Home Infusion Therapy Services
    This final rule summarizes the home infusion therapy policies 
codified in the CY 2020 HH PPS final rule with comment period (84 FR 
60615), as required by section 1834(u) of the Act. This rule also 
finalizes the exclusion of

[[Page 70299]]

home infusion therapy services from coverage under the Medicare home 
health benefit as required by section 5012(c)(3) of the 21st Century 
Cures Act.
6. Enrollment Requirements for Qualified Home Infusion Therapy 
Suppliers
    This final rule establishes Medicare provider enrollment policies 
for qualified home infusion therapy suppliers.

B. Summary of the Provisions of This Rule

    In section III.A of this rule, we set the LUPA thresholds and the 
case-mix weights for CY 2021 equal to the CY 2020 LUPA thresholds and 
case-mix weights established for the first year of the Patient-Driven 
Groupings Model (PDGM). The PDGM is a new case-mix adjustment 
methodology used to adjust payments for home health periods of care 
beginning on or after January 1, 2020. The PDGM relies more heavily on 
clinical characteristics and other patient information to place 
patients into meaningful payment categories and eliminates the use of 
therapy service thresholds, as required by section 1895(b)(4)(B) of the 
Act, as amended by section 51001(a)(3) of the Bipartisan Budget Act of 
2018 (BBA of 2018).
    Section III.B. of this rule adopts the OMB statistical area 
delineations outlined in a September 14, 2018, OMB bulletin No. 18-04. 
This rule also finalizes the transition with a 1-year cap on wage index 
decreases in excess of 5 percent, consistent with the policy finalized 
for other Medicare payment systems. This rule adopts the OMB 
statistical areas and the 5 percent cap on wage index decreases under 
the statutory discretion afforded to the Secretary under sections 
1895(b)(4)(A)(ii) and (b)(4)(C) of the Act.
    In section III.C. of this rule, we update the home health wage 
index, the CY 2021 national, standardized 30-day period of care payment 
amounts and the CY 2021 national per-visit payment amounts by the home 
health payment update percentage. The home health payment update 
percentage for CY 2021 is 2.0 percent. Section III.D. of this rule 
describes the rural add-on payments as required by section 
50208(a)(1)(D) of the BBA of 2018 for home health episodes or periods 
ending during CYs 2019 through 2022. Section III.E. of this rule 
maintains the fixed-dollar loss ratio at 0.56, as finalized for CY 
2020, in order to ensure that outlier payments as a percentage of total 
payments is closer to, but no more than, 2.5 percent, as required by 
section 1895(b)(5)(A) of the Act.
    Section III.F. of this rule finalizes the changes to Sec.  
409.43(a) as implemented in the March, 2020 COVID-19 IFC, to state that 
the plan of care must include any provision of remote patient 
monitoring or other services furnished via a telecommunications system 
and that these services cannot substitute for a home visit ordered as 
part of the plan of care and cannot be considered a home visit for the 
purposes of patient eligibility or payment, in accordance with section 
1895(e)(1)(A) of the Act. Section III.G. of this rule, finalizes 
conforming regulation text changes at Sec. Sec.  409.64(a)(2)(ii), 
410.170(b), and 484.110 regarding allowed practitioner certification as 
a condition for payment for home health services.
    Section IV.A and B. of this final rule discuss the HH QRP and 
changes to the Conditions of Participation (CoPs) OASIS requirements.
    Section IV.C. of this final rule discusses final policies on 
reporting under the HHVBP Model during the COVID-19 PHE.
    In sections V.A.1. and V.A.2. of this rule, we discuss the 
background and overview of the home infusion therapy services benefit, 
as well as review the payment policies we finalized in the CY 2020 HH 
PPS final rule with comment period for the CY 2021 implementation (84 
FR 60628). Sections V.A.3. and V.A.4. describe the payment categories 
and payment amounts for home infusion therapy services for CY 2021, as 
well as payment adjustments for CY 2021 home infusion therapy services. 
In section V.A.5. of this rule, we finalize technical regulations text 
changes to exclude home infusion therapy services from coverage under 
the Medicare home health benefit, as required by section 5012(c)(3) of 
the 21st Century Cures Act, which amended section 1861(m) of the Act. 
In section V.B. of this rule, we discuss the home infusion therapy 
supplier enrollment requirements.

C. Summary of Costs, Transfers, and Benefits

BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR04NO20.001

BILLING CODE 4120-01-C

D. Issuance of the Proposed Rulemaking and Correction

    In the CY 2021 HH PPS proposed rule that appeared in the June 30, 
2020 Federal Register (85 FR 39408), we proposed changes to the payment 
rates, factors, and other payment and policy-related changes to 
programs associated with under the HH PPS for CY 2021 and home infusion 
therapy services benefit for CY 2021. In addition, we set forth 
proposed changes to the reporting of OASIS requirements and 
requirements for home infusion therapy suppliers.
    We note that Office of the Federal Register issued a correction to 
the comment period closing date for the CY 2021 HH PPS proposed rule in 
the July 20, 2020 Federal Register (85 FR 43805). The correct closing 
date for public comments was August 24, 2020.
    We note that in response to the CY 2021 HH PPS proposed rule, we 
received approximately 162 timely pieces of correspondence from the

[[Page 70301]]

public, including from home health agencies, national and state 
provider associations, patient and other advocacy organizations, 
nurses, and other healthcare professionals. In the following sections, 
we summarize the proposed provisions and the public comments, and 
provide the responses to comments.

II. Overview of the Home Health Prospective Payment System (HH PPS)

A. Statutory Background

    The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted 
August 5, 1997), significantly changed the way Medicare pays for 
Medicare home health services. Section 4603 of the BBA mandated the 
development of the HH PPS. Until the implementation of the HH PPS on 
October 1, 2000, HHAs received payment under a retrospective 
reimbursement system. Section 4603(a) of the BBA mandated the 
development of a HH PPS for all Medicare-covered home health services 
provided under a plan of care (POC) that were paid on a reasonable cost 
basis by adding section 1895 of the Act, entitled ``Prospective Payment 
for Home Health Services.'' Section 1895(b)(1) of the Act requires the 
Secretary to establish a HH PPS for all costs of home health services 
paid under Medicare. Section 1895(b)(2) of the Act required that, in 
defining a prospective payment amount, the Secretary will consider an 
appropriate unit of service and the number, type, and duration of 
visits provided within that unit, potential changes in the mix of 
services provided within that unit and their cost, and a general system 
design that provides for continued access to quality services.
    Section 1895(b)(3)(A) of the Act required the following: (1) The 
computation of a standard prospective payment amount that includes all 
costs for 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 (as of the 
effective date of the 2000 final rule); and (2) the standardized 
prospective payment amount be adjusted to account for the effects of 
case-mix and wage levels among HHAs.
    Section 1895(b)(3)(B) of the Act requires the standard prospective 
payment amounts be annually updated by the home health applicable 
percentage increase. Section 1895(b)(4) of the Act governs the payment 
computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act 
require the standard prospective payment amount to be adjusted for 
case-mix and geographic differences in wage levels. Section 
1895(b)(4)(B) of the Act requires the establishment of an appropriate 
case-mix change adjustment factor for significant variation in costs 
among different units of services.
    Similarly, section 1895(b)(4)(C) of the Act requires the 
establishment of area wage adjustment factors that reflect the relative 
level of wages, and wage-related costs applicable to home health 
services furnished in a geographic area compared to the applicable 
national average level. Under section 1895(b)(4)(C) of the Act, the 
wage adjustment factors used by the Secretary may be the factors used 
under section 1886(d)(3)(E) of the Act. Section 1895(b)(5) of the Act 
gives the Secretary the option to make additions or adjustments to the 
payment amount otherwise paid in the case of outliers due to unusual 
variations in the type or amount of medically necessary care. Section 
3131(b)(2) of the Affordable Care Act revised section 1895(b)(5) of the 
Act so that total outlier payments in a given year would not exceed 2.5 
percent of total payments projected or estimated. The provision also 
made permanent a 10 percent agency-level outlier payment cap.
    In accordance with the statute, as amended by the BBA, we published 
a final rule in the July 3, 2000 Federal Register (65 FR 41128) to 
implement the HH PPS legislation. The July 2000 final rule established 
requirements for the new HH PPS for home health services as required by 
section 4603 of the BBA, as subsequently amended by section 5101 of the 
Omnibus Consolidated and Emergency Supplemental Appropriations Act for 
Fiscal Year 1999 (OCESAA), (Pub. L. 105-277, enacted October 21, 1998); 
and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP 
Balanced Budget Refinement Act of 1999, (BBRA) (Pub. L. 106-113, 
enacted November 29, 1999). The requirements include the implementation 
of a HH PPS for home health services, consolidated billing 
requirements, and a number of other related changes. The HH PPS 
described in that rule replaced the retrospective reasonable cost-based 
system that was used by Medicare for the payment of home health 
services under Part A and Part B. For a complete and full description 
of the HH PPS as required by the BBA, see the July 2000 HH PPS final 
rule (65 FR 41128 through 41214).
    Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) 
to the Act, requiring HHAs to submit data for purposes of measuring 
health care quality, and linking the quality data submission to the 
annual applicable payment percentage increase. This data submission 
requirement is applicable for CY 2007 and each subsequent year. If an 
HHA does not submit quality data, the home health market basket 
percentage increase is reduced by 2.0 percentage points. In the 
November 9, 2006 Federal Register (71 FR 65935), we published a final 
rule to implement the pay-for-reporting requirement of the DRA, which 
was codified at Sec.  484.225(h) and (i) in accordance with the 
statute. The pay-for-reporting requirement was implemented on January 
1, 2007.
    The Affordable Care Act made additional changes to the HH PPS. One 
of the changes in section 3131 of the Affordable Care Act is the 
amendment to section 421(a) of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, 
enacted on December 8, 2003) as amended by section 5201(b) of the DRA. 
Section 421(a) of the MMA, as amended by section 3131 of the Affordable 
Care Act, requires that the Secretary increase, by 3 percent, the 
payment amount otherwise made under section 1895 of the Act, for home 
health 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 1.0 percent market basket increase. Section 
50208(a)(1) of the BBA of 2018 again extended the 3.0 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.
    Section 51001(a)(1)(B) of the BBA of 2018 amended section 1895(b) 
of the Act to require a change to the home health unit of payment to 
30-day periods beginning January 1, 2020. Section 51001(a)(2)(A) of the 
BBA of 2018 added a new subclause (iv) under section 1895(b)(3)(A) of 
the Act, requiring the Secretary to calculate a standard prospective 
payment amount (or amounts) for 30-day units of service, furnished that 
end during the 12-month period beginning January 1, 2020, in a

[[Page 70302]]

budget neutral manner, such that estimated aggregate expenditures under 
the HH PPS during CY 2020 are equal to the estimated aggregate 
expenditures that otherwise would have been made under the HH PPS 
during CY 2020 in the absence of the change to a 30-day unit of 
service. Section 1895(b)(3)(A)(iv) of the Act requires that the 
calculation of the standard prospective payment amount (or amounts) for 
CY 2020 be made before the application of the annual update to the 
standard prospective payment amount as required by section 
1895(b)(3)(B) of the Act.
    Additionally, section 1895(b)(3)(A)(iv) of the Act requires that in 
calculating the standard prospective payment amount (or amounts), the 
Secretary must make assumptions about behavior changes that could occur 
as a result of the implementation of the 30-day unit of service under 
section 1895(b)(2)(B) of the Act and case-mix adjustment factors 
established under section 1895(b)(4)(B) of the Act. Section 
1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide 
a description of the behavior assumptions made in notice and comment 
rulemaking. CMS finalized these behavior assumptions in the CY 2019 HH 
PPS final rule with comment period (83 FR 56461).
    Section 51001(a)(2)(B) of the BBA of 2018 also added a new 
subparagraph (D) to section 1895(b)(3) of the Act. Section 
1895(b)(3)(D)(i) of the Act requires the Secretary to annually 
determine the impact of differences between assumed behavior changes as 
described in section 1895(b)(3)(A)(iv) of the Act, and actual behavior 
changes on estimated aggregate expenditures under the HH PPS with 
respect to years beginning with 2020 and ending with 2026. Section 
1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a 
manner determined appropriate, through notice and comment rulemaking, 
to provide for one or more permanent increases or decreases to the 
standard prospective payment amount (or amounts) for applicable years, 
on a prospective basis, to offset for such increases or decreases in 
estimated aggregate expenditures, as determined under section 
1895(b)(3)(D)(i) of the Act. Additionally, 1895(b)(3)(D)(iii) of the 
Act requires the Secretary, at a time and in a manner determined 
appropriate, through notice and comment rulemaking, to provide for one 
or more temporary increases or decreases, based on retrospective 
behavior, to the payment amount for a unit of home health services for 
applicable years, on a prospective basis, to offset for such increases 
or decreases in estimated aggregate expenditures, as determined under 
section 1895(b)(3)(D)(i) of the Act. Such a temporary increase or 
decrease shall apply only with respect to the year for which such 
temporary increase or decrease is made, and the Secretary shall not 
take into account such a temporary increase or decrease in computing 
the payment amount for a unit of home health services for a subsequent 
year. And finally, section 51001(a)(3) of the BBA of 2018 amends 
section 1895(b)(4)(B) of the Act by adding a new clause (ii) to require 
the Secretary to eliminate the use of therapy thresholds in the case-
mix system for CY 2020 and subsequent years.

B. Current System for Payment of Home Health Services Beginning in CY 
2020 and Subsequent Years

    For home health periods of care beginning on or after January 1, 
2020, Medicare makes payment under the HH PPS on the basis of a 
national, standardized 30-day period payment rate that is adjusted for 
the applicable case-mix and wage index in accordance with section 
51001(a)(1)(B) of the BBA of 2018. The national, standardized 30-day 
period 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 now part of the national, standardized 30-day 
period rate. Durable medical equipment provided as a home health 
service as defined in section 1861(m) of the Act is paid the fee 
schedule amount and is not included in the national, standardized 30-
day period payment amount.
    To better align payment with patient care needs and ensure that 
clinically complex and ill beneficiaries have adequate access to home 
health care, in the CY 2019 HH PPS final rule with comment period (83 
FR 56406), we finalized case-mix methodology refinements through the 
Patient-Driven Groupings Model (PDGM) for home health periods of care 
beginning on or after January 1, 2020. To adjust for case-mix for 30-
day periods of care beginning on and after January 1, 2020, the HH PPS 
uses a 432-category case mix classification system to assign patients 
to a home health resource group (HHRG) using patient characteristics 
and other clinical information from Medicare claims and the Outcome and 
Assessment Information Set (OASIS) assessment instrument. These 432 
HHRGs represent the different payment groups based on five main case-
mix variables under the PDGM, as shown in Figure 1, and subsequently 
described in more detail throughout this section. Each HHRG has an 
associated case-mix weight that is used in calculating the payment for 
a 30-day period of care. For periods of care with visits less than the 
low-utilization payment adjustment (LUPA) threshold for the HHRG, 
Medicare pays national per-visit rates based on the discipline(s) 
providing the services. Medicare also adjusts the national standardized 
30-day period payment rate for certain intervening events that are 
subject to a partial payment adjustment (PEP adjustment). For certain 
cases that exceed a specific cost threshold, an outlier adjustment may 
also be available.
    Under this new case-mix methodology, case-mix weights are generated 
for each of the different PDGM payment groups by regressing resource 
use for each of the five categories listed in this section of this 
final rule (admission source, timing clinical grouping, functional 
impairment level, and comorbidity adjustment) using a fixed effects 
model. Below is a description of each of the case-mix variables under 
the PDGM.

[[Page 70303]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.000

1. Timing
    Thirty-day periods of care are classified as ``early'' or ``late'' 
depending on when they occur within a sequence of 30-day periods. The 
first 30-day period of care is classified as early and all subsequent 
30-day periods of care in the sequence (second or later) are classified 
as late. A 30-day period is not considered early unless there is a gap 
of more than 60 days between the end of one period of care and the 
start of another. Information regarding the timing of a 30-day period 
of care comes from Medicare home health claims data and not the OASIS 
assessment to determine if a 30-day period of care is ``early'' or 
``late''. While the PDGM case-mix adjustment is applied to each 30-day 
period of care, other home health requirements continue on a 60-day 
basis. Specifically, certifications and re-certifications continue on a 
60-day basis and the comprehensive assessment must 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.''
2. Admission Source
    Each 30-day period of care is classified into one of two admission 
source categories--community or institutional--depending on what 
healthcare setting was utilized in the 14 days prior to home health. 
Thirty-day periods of care for beneficiaries with any inpatient acute 
care hospitalizations, inpatient psychiatric facility (IPF) stays, 
skilled nursing facility (SNF) stays, inpatient rehabilitation facility 
(IRF) stays, or long-term care hospital (LTCH) stays within 14-days 
prior to a home health admission are designated as institutional 
admissions.
    The institutional admission source category also includes 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

[[Page 70304]]

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 do not categorize post-acute care 
stays, meaning SNF, IRF, LTCH, or IPF stays, that occur during a 
previous 30-day period of care and within 14 days of a subsequent, 
contiguous 30-day period of care as institutional (that is, the 
``admission date'' and ``from date'' for the subsequent 30-day period 
of care do not match), as HHAs should discharge the patient if the 
patient required post-acute care in a different setting, or inpatient 
psychiatric care, and then readmit the patient, if necessary, after 
discharge from such setting. All other 30-day periods of care would be 
designated as community admissions.
    Information from the Medicare claims processing system determines 
the appropriate admission source for final claim payment. The OASIS 
assessment is not utilized in evaluating for admission source 
information. Obtaining this information from the Medicare claims 
processing system, rather than as reported on the OASIS, is a more 
accurate way to determine admission source information as HHAs may be 
unaware of an acute or post-acute care stay prior to home health 
admission. While HHAs can report an occurrence code on submitted claims 
to indicate the admission source, obtaining this information from the 
Medicare claims processing system allows CMS the opportunity and 
flexibility to verify the source of the admission and correct any 
improper payments as deemed appropriate. When the Medicare claims 
processing system receives a Medicare home health claim, the systems 
check for the presence of a Medicare acute or post-acute care claim for 
an institutional stay. If such an institutional claim is found, and the 
institutional claim occurred within 14 days of the home health 
admission, our systems trigger an automatic adjustment to the 
corresponding home health claim to the appropriate institutional 
category. Similarly, when the Medicare claims processing system 
receives a Medicare acute or post-acute care claim for an institutional 
stay, the systems will check for the presence of a home health claim 
with a community admission source payment group. If such home health 
claim is found, and the institutional stay occurred within 14 days 
prior to the home health admission, our systems trigger an automatic 
adjustment of the home health 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. For the purpose of a 
Request for Anticipated Payment (RAP), only the final claim will be 
adjusted to reflect the admission source. More information regarding 
the admission source reporting requirements for RAP and claims 
submission, including the use of admission source occurrence codes, can 
be found in the Medicare Claims Processing Manual, chapter 10.\2\
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    \2\ Medicare Claims Processing Manual Chapter 10--Home Health 
Agency Billing. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c10.pdf.
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3. Clinical Groupings
    Each 30-day period of care is grouped into one of 12 clinical 
groups that describe the primary reason for which patients are 
receiving home health services under the Medicare home health benefit. 
The clinical grouping is based on the principal diagnosis reported on 
home health claims. The 12 clinical groups are listed and described in 
Table 2.
[GRAPHIC] [TIFF OMITTED] TR04NO20.002

    If a home health claim is submitted with a principal diagnosis that 
is not assigned to a clinical group (for example, because the diagnosis 
code is vague, ill-defined, unspecified, or is subject to certain ICD-
10-CM coding conventions), the claim is returned to the provider for 
more definitive coding. While these clinical groups represent

[[Page 70305]]

the primary reason for home health services during a 30-day period of 
care, this does not mean that they represent the only reason for home 
health services. Home health remains a multidisciplinary benefit and 
payment is bundled to cover all necessary home health services 
identified on the individualized home health plan of care. Therefore, 
regardless of the clinical group assignment, HHAs are required, in 
accordance with the home health CoPs at Sec.  484.60(a)(2), to ensure 
that the individualized home health plan of care addresses all care 
needs, including the disciplines to provide such care. Under the PDGM, 
the clinical group is just one variable in the overall case-mix 
adjustment for a home health period of care. Moreover, it is possible 
for the principal diagnosis to change between the first and second 30-
day period of care and the claim for the second 30-day period of care 
would reflect the new principal diagnosis. HHAs would not change the 
claim for the first 30-day period.
4. Functional Impairment Level
    Each 30-day period of care will be placed into one of three 
functional impairment levels, low, medium, or high, based on responses 
to certain OASIS functional items associated with grooming, bathing, 
dressing, ambulating, transferring, and risk for hospitalization. The 
specific OASIS items that are used for the functional impairment level 
are found in Table 7 in the CY 2020 HH PPS final rule with comment 
period (84 FR 60490). Responses to these OASIS items are grouped 
together into response categories with similar resource use and each 
response category has associated points. A more detailed description as 
to how these response categories were established can be found in the 
technical report, ``Overview of the Home Health Groupings Model'', 
which is posted on our HHA web page.\3\ The sum of these points' 
results in a functional impairment level score used to group 30-day 
periods of care into a functional impairment level with similar 
resource use. The scores associated with the functional impairment 
levels vary by clinical group to account for differences in resource 
utilization. The functional impairment level will remain the same for 
the first and second 30-day periods of care unless there has been a 
significant change in condition which warranted an ``other follow-up'' 
assessment prior to the second 30-day period of care. For each 30-day 
period of care, the Medicare claims processing system will look for the 
most recent OASIS assessment based on the claims ``from date.''
---------------------------------------------------------------------------

    \3\ Overview of the Home Health Groupings Model. November 18, 
2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------

5. Comorbidity Adjustment
    Thirty-day periods will receive a comorbidity adjustment category 
based on the presence of certain secondary diagnoses reported on home 
health claims. These diagnoses are based on a home-health specific list 
of clinically and statistically significant secondary diagnosis 
subgroups with similar resource use, meaning the secondary diagnoses 
have at least as high as the median resource use and represent more 
than 0.1 percent of 30-day periods of care. Home health 30-day periods 
of care can receive a comorbidity adjustment under the following 
circumstances:
     Low comorbidity adjustment: There is a reported 
secondary diagnosis on the home health-specific comorbidity subgroup 
list that is associated with higher resource use.
     High comorbidity adjustment: There are two or 
more secondary diagnoses on the home health-specific comorbidity 
subgroup interaction list that are associated with higher resource use 
when both are reported together compared to if they were reported 
separately. That is, the two diagnoses may interact with one another, 
resulting in higher resource use.
     No comorbidity adjustment: A 30-day period of 
care will receive no comorbidity adjustment if no secondary diagnoses 
exist or none meet the criteria for a low or high comorbidity 
adjustment. A 30-day period of care can have a low comorbidity 
adjustment or a high comorbidity adjustment, but not both. A 30-day 
period of care can receive only one low comorbidity adjustment 
regardless of the number of secondary diagnoses reported on the home 
health claim that fell into one of the individual comorbidity subgroups 
or one high comorbidity adjustment regardless of the number of 
comorbidity group interactions, as applicable. The low comorbidity 
adjustment amount will be the same across the subgroups and the high 
comorbidity adjustment will be the same across the subgroup 
interactions.

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

A. CY 2021 PDGM Low-Utilization Payment Adjustment (LUPA) Thresholds 
and PDGM Case-Mix Weights

1. CY 2021 PDGM LUPA Thresholds
    Under the HH PPS, low utilization payment adjustments (LUPAs) are 
paid when a certain visit threshold for a payment group during a 30-day 
period of care is not met. The approach to calculating the LUPA 
thresholds under the PDGM changed to account for the 30-day unit of 
payment. Therefore, in order to target the same percentage of LUPA 
periods as under the previous 153-group case-mix system (that is, 
approximately 7-8 percent of 30-day periods would be LUPAs), in the CY 
2019 HH PPS final rule with comment period (83 FR 56492), we finalized 
that the LUPA thresholds would be set at the 10th percentile of visits 
or 2 visits, whichever is higher, for each payment group. This means 
that the LUPA threshold for each 30-day period of care varies depending 
on the PDGM payment group to which it is assigned. If the LUPA 
threshold for the payment group is met under the PDGM, the 30-day 
period of care will be paid the full 30-day period case-mix adjusted 
payment amount. If a 30-day period of care does not meet the PDGM LUPA 
visit threshold, then payment will be made using the CY 2021 per-visit 
payment amounts as described in section III.C.3.c. of this final rule. 
For example, if the LUPA visit threshold is four, and a 30-day period 
of care has four or more visits, it is paid the full 30-day period 
payment amount; if the period of care has three or less visits, payment 
is made using the per-visit payment amounts.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56492), 
we finalized our policy that the LUPA thresholds for each PDGM payment 
group would be reevaluated every year based on the most current 
utilization data available at the time of rulemaking. However, CY 2020 
was the first year of the new case-mix adjustment methodology and 30-
day unit of payment and at this time we do not have sufficient CY 2020 
data in which to make any changes to the LUPA thresholds for CY 2021. 
We believe that making any changes to the LUPA thresholds for CY 2021 
based off 2019 utilization using the 153-group model would result in 
little change in the LUPA thresholds from CY 2020 to CY 2021 and would 
result in additional burden to HHAs and software vendors in revising 
their internal billing software

[[Page 70306]]

to reflect only minor changes. Therefore, we proposed to maintain the 
LUPA thresholds finalized and shown in Table 17 of the CY 2020 HH PPS 
final rule with comment period (84 FR 60522) for CY 2021 payment 
purposes. We will repost the LUPA thresholds (along with the case-mix 
weights) that will be used for CY 2021 on the HHA Center and PDGM web 
pages.
2. CY 2021 PDGM Case-Mix Weights
    As finalized in the CY 2019 HH PPS final rule with comment period 
(83 FR 56502), the PDGM places patients into meaningful payment 
categories based on patient and other characteristics, such as timing, 
admission source, clinical grouping using the reported principal 
diagnosis, functional impairment level, and comorbid conditions. The 
PDGM case-mix methodology results in 432 unique case-mix groups called 
HHRGs. We also finalized in the CY 2019 HH PPS final rule with comment 
period (83 FR 56515) our policy to annually recalibrate the PDGM case-
mix weights using a fixed effects model using the most recent, complete 
utilization data available at the time of annual rulemaking. However, 
as noted previously, we do not have sufficient CY 2020 data from the 
first year of the new case-mix methodology and because the 2019 data 
utilize the old 153-case-mix methodology and 60-day episodes of 
payment, such data are not appropriate for use to simulate 30-day 
periods under the PDGM in order to recalibrate the case-mix weights for 
CY 2021. Therefore, we proposed to maintain the PDGM case-mix weights 
finalized and shown in Table 16 of the CY 2020 HH PPS final rule with 
comment period (84 FR 60522) for CY 2021 payment purposes.
    We will repost the case-mix weights for CY 2021 on the HHA Center 
and PDGM web pages. As mentioned previously in this section, we believe 
this approach for CY 2021 is more accurate, given the limited 
utilization data for CY 2020; and that the approach will be less 
burdensome for HHAs and software vendors, who continue to familiarize 
themselves with this new case-mix methodology.

B. Home Health Wage Index Changes

1. Implementation of New Labor Market Delineations
    Generally, OMB issues major revisions to statistical areas every 10 
years, based on the results of the decennial census. However, OMB 
occasionally issues minor updates and revisions to statistical areas in 
the years between the decennial censuses. On April 10, 2018 OMB issued 
OMB Bulletin No. 18-03 which superseded the August 15, 2017 OMB 
Bulletin No. 17-01. On September 14, 2018, OMB issued, OMB Bulletin No. 
18-04, which superseded the April 10, 2018 OMB Bulletin No. 18-03. 
These bulletins established revisions to the delineation of MSAs, 
Micropolitan Statistical Areas, and Combines Statistical Areas, and 
guidance on uses of the delineation in these areas. A copy of the 
September 2018 bulletin is available at: https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf. We note that on March 6, 
2020 OMB issued OMB Bulletin No. 20-01 (available at https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf. 
Bulletin No. 18-04 states it ``provides the delineations of all 
Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan 
Statistical Areas, Combined Statistical Areas, and New England City and 
Town Areas in the United States and Puerto Rico based on the standards 
published in the June 28, 2010, Federal Register (75 FR 37246 through 
37252), and Census Bureau data.''
    While the revisions OMB published on September 14, 2018, are not as 
sweeping as the changes made when we adopted the CBSA geographic 
designations for CY 2006, the September 14, 2018 bulletin does contain 
a number of significant changes. For example, there are new CBSAs, 
urban counties that have become rural, rural counties that have become 
urban, and existing CBSAs that have been split apart. We believe it is 
important for the home health wage index to use the latest OMB 
delineations available in order to maintain a more accurate and up-to-
date payment system that reflects the reality of population shifts and 
labor market conditions. We further believe that using the September 
2018 OMB delineations would increase the integrity of the HH PPS wage 
index by creating a more accurate representation of geographic 
variation in wage levels. We have reviewed our findings and impacts 
relating to the new OMB delineations, and have concluded that there is 
no compelling reason to further delay implementation. We proposed to 
implement the new OMB delineations as described in the September 14, 
2018 OMB Bulletin No. 18-04 for the home health wage index effective 
beginning in CY 2021. As noted previously, the March 6, 2020 OMB 
Bulletin No. 20-01 was not available in time for development of the 
proposed rule. We will include any updates from OMB Bulletin No. 20-01 
in any changes that would be adopted in future rulemaking.
(a) Micropolitan Statistical Areas
    As discussed in the CY 2006 HH PPS proposed rule (70 FR 40788) and 
final rule (70 FR 68132), CMS considered how to use the Micropolitan 
statistical area definitions in the calculation of the wage index. OMB 
defines a ``Micropolitan Statistical Area'' as a ``CBSA'' associated 
with at least one urban cluster that has a population of at least 
10,000, but less than 50,000 (75 FR 37252). We refer to these as 
Micropolitan Areas. After extensive impact analysis, consistent with 
the treatment of these areas under the IPPS as discussed in the FY 2005 
IPPS final rule (69 FR 49029 through 49032), we determined the best 
course of action would be to treat Micropolitan Areas as ``rural'' and 
include them in the calculation of each state's home health rural wage 
index (see 70 FR 40788 and 70 FR 68132). Thus, the HH PPS statewide 
rural wage index is determined using IPPS hospital data from hospitals 
located in non-Metropolitan Statistical Areas (MSA).
    Based upon the 2010 Decennial Census data, a number of urban 
counties have switched status and have joined or became Micropolitan 
Areas, and some counties that once were part of a Micropolitan Area, 
have become urban. Overall, there are fewer Micropolitan Areas (542) 
under the new OMB delineations based on the 2010 Census than existed 
under the latest data from the 2000 Census (581). We believe that the 
best course of action would be to continue the policy established in 
the CY 2006 HH PPS final rule and include Micropolitan Areas in each 
state's rural wage index. These areas continue to be defined as having 
relatively small urban cores (populations of 10,000 to 49,999). 
Therefore, in conjunction with our proposal to implement the new OMB 
labor market delineations beginning in CY 2021 and consistent with the 
treatment of Micropolitan Areas under the IPPS, we proposed to continue 
to treat Micropolitan Areas as ``rural'' and to include Micropolitan 
Areas in the calculation of each state's rural wage index.
(b) Urban Counties Becoming Rural
    Under the new OMB delineations (based upon the 2010 decennial 
Census data), a total of 34 counties (and county equivalents) that are 
currently considered urban are considered rural beginning in CY 2021. 
Table 3 lists the 34 counties that are changing to rural

[[Page 70307]]

status with the implementation of the new OMB delineations.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR04NO20.003

(c) Rural Counties Becoming Urban
    Under the new OMB delineations (based upon the 2010 decennial 
Census data), a total of 47 counties (and county equivalents) that are 
currently designated rural and are considered urban beginning in CY 
2021. Table 4 lists the 47 counties that are changing to urban status.

[[Page 70308]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.004


[[Page 70309]]


(d) Urban Counties Moving to a Different Urban CBSA
    In addition to rural counties becoming urban and urban counties 
becoming rural, several urban counties are shifting from one urban CBSA 
to another urban CBSA upon implementation of the new OMB delineations 
(Table 5). In other cases, applying the new OMB delineations involves a 
change only in CBSA name or number, while the CBSA continues to 
encompass the same constituent counties. For example, CBSA 19380 
(Dayton, OH) experiences both a change to its number and its name, and 
becomes CBSA 19430 (Dayton-Kettering, OH), while all of its three 
constituent counties remain the same. In other cases, only the name of 
the CBSA is modified, and none of the currently assigned counties are 
reassigned to a different urban CBSA. We are not discussing these 
changes in this section because they are inconsequential changes with 
respect to the home health wage index.
[GRAPHIC] [TIFF OMITTED] TR04NO20.005

    However, in other cases, under the new OMB delineations, counties 
shift between existing and new CBSAs, changing the constituent makeup 
of the CBSAs. In another type of change, some CBSAs have counties that 
split off to become part of or to form entirely new labor market areas. 
Finally, in some cases, a CBSA loses counties to another existing CBSA 
after implementing the new OMB delineations. Table 6 lists the urban 
counties moving from one urban CBSA to a newly or modified CBSA under 
the new OMB delineations.

[[Page 70310]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.006

BILLING CODE 4120-01-C
2. Transition Period
    As discussed previously, overall, we believe that adopting the 
revised OMB delineations for CY 2021 results in HH PPS wage index 
values being more representative of the actual costs of labor in a 
given area. However, we also recognize that some home health agencies 
would experience decreases in their area wage index values as a result 
of our proposal. We also realize that many home health agencies would 
have higher area wage index values under the new OMB delineations.
    To mitigate the potential impacts of proposed policies on home 
health agencies, we have in the past provided for transition periods 
when adopting changes that have significant payment implications, 
particularly large negative impacts. For example, we have proposed and 
finalized budget neutral transition policies to help mitigate negative 
impacts on home health agencies following the adoption of the new CBSA 
delineations based on the 2010 decennial census data in the CY 2015 
home health final rule (79 FR 66032). Specifically, we implemented a 1-
year 50/50 blended wage to the new OMB delineations. We applied a 
blended wage index for 1 year (CY 2015) for all geographic areas that 
would consist of a 50/50 blend of the wage index values using OMB's old 
area delineations and the wage index values using OMB's new area 
delineations. That is, for each county, a blended wage index was 
calculated equal to 50 percent of the CY 2015 wage index using the old 
labor market area delineation and 50 percent of the CY 2015 wage index 
using the new labor market area delineation, which resulted in an 
average of the two values. While we believed that using the new OMB 
delineations would create a more accurate payment adjustment for 
differences in area wage levels, we also recognized that adopting such 
changes may cause some short-term instability in home health payments. 
Similar instability may result from the proposed wage policies herein, 
in particular for home health agencies that would be negatively 
impacted by the proposed adoption of the updates to the OMB 
delineations. We proposed a transition policy to help mitigate any 
significant negative impacts that home health agencies may experience 
due to our proposal to adopt the revised OMB delineations.
    Specifically, for CY 2021 as a transition, we proposed to apply a 5 
percent cap on any decrease in a geographic area's wage index value 
from the wage index value from the prior calendar year. This transition 
allows the effects of the adoption of the revised CBSA delineations to 
be phased in over 2 years, where the estimated reduction in a 
geographic area's wage index would be capped at 5 percent in CY 2021 
(that is, no cap would be applied to the reduction in the wage index 
for the second year (CY 2022)). We believe a 5 percent cap on the 
overall decrease in a geographic area's wage index value, regardless of 
the circumstance causing the decline, is an appropriate transition for 
CY 2021 as it provides predictability in payment levels from CY 2020 to 
the upcoming CY 2021 and additional transparency because it is 
administratively simpler than our prior 1-year 50/50 blended wage index 
approach. Consistent with the policy finalized under the IPPS and 
finalized in other Medicare settings, we believe 5 percent is a 
reasonable level for the cap because it would effectively mitigate any 
significant decreases in a geographic area's wage index value for CY 
2021 that could result from the adoption of the new OMB delineations.

[[Page 70311]]

We believe a 1-year 5 percent cap provides home health agencies 
sufficient time to plan appropriately for CY 2022 and subsequent years. 
Because we believe that using the new OMB delineations would create a 
more accurate payment adjustment for differences in area wage levels we 
proposed to include a cap on the overall decrease in a geographic 
area's wage index value.
    While there are some minimal impacts on certain HHAs as a result of 
the 5 percent cap as shown in the regulatory impact analysis of this 
final rule, overall, the impact between the CY 2021 wage index using 
the old OMB delineations and the CY 2021 wage index using the new OMB 
delineations would be 0.0 percent due to the wage index budget 
neutrality factor, which ensures that wage index updates and revisions 
are implemented in a budget-neutral manner.
    We received several comments on the FY 2021 home health wage index 
proposals from various stakeholders including home health agencies, 
national industry associations and MedPAC. A summary of these comments 
and our responses to those comments are as follows:
    Comment: Commenters generally supported the adoption of the revised 
OMB delineations from the September 14, 2018 Bulletin No. 18-04 and the 
proposed transition methodology that would apply a 5 percent cap on 
decreases to a geographic area's wage index value relative to the wage 
index value from the prior calendar year.
    Response: We appreciate the commenters' support of the adoption of 
the new OMB delineations and a 5 percent cap on wage index decreases 
for CY 2021 as an appropriate transition policy.
    Comment: A few commenters recommended that CMS reconsider the 
implementation of the revised OMB delineations. A few commenters stated 
their concerns regarding potential wage index decreases in the newly 
created New Brunswick-Lakewood, NJ CBSA. A commenter suggested the 
redefinition of the New York-Jersey City-White Plains, NY-NJ CBSA will 
cause major Medicare reimbursement reductions across many hospitals and 
other providers, including Home Health Agencies, in New York and New 
Jersey.
    Response: We appreciate the concerns sent in by the commenters 
regarding the impact of implementing the New Brunswick-Lakewood, NJ 
CBSA designation on their specific counties. While we understand the 
commenters' concern regarding the potential financial impact, we 
believe that implementing the revised OMB delineations will create more 
accurate representations of labor market areas nationally and result in 
home health wage index values being more representative of the actual 
costs of labor in a given area. Although this comment only addressed 
the negative impact on the commenter's geographic area, we believe it 
is important to note that there are many geographic locations and home 
health providers that will experience positive impacts upon 
implementation of the revised CBSA designations. We recognize there are 
areas that will experience a decrease in their wage index. As such, in 
the CY 2021 HH PPS proposed rule, we proposed a transition in order to 
mitigate the resulting short-term instability and negative impacts on 
certain providers and to provide time for providers to adjust to their 
new labor market delineations. We continue to believe that the 1-year 5 
percent cap transition policy provides an adequate safeguard against 
any significant payment reductions in CY 2021 while improving the 
accuracy of the payment adjustment for differences in area wage levels. 
Therefore, we believe that it is appropriate to implement the new OMB 
delineations without further delay.
    Comment: Several commenters stated that they were interested in 
gaining a deeper understanding of the impact of the 5 percent cap 
transition policy compared to the 50/50 blend transition that we have 
used in the past. These commenters recommended that CMS develop and 
make public an impact analysis of applying the previous transition 
approach in implementing new wage areas in the wage index where a 50/50 
blend of old and new indexes was used. A commenter also suggested that 
for CY 2021, both the 50/50 blend transition and the 5 percent cap on 
reductions should be used for this transition.
    Response: We thank the commenters for their recommendations. We 
continue to believe that the 5 percent cap on wage index decreases is 
the best transition approach for CY 2021. We note that the use of a 50/
50 blended wage index transition or a combination of the 50/50 blend 
and the 5 percent cap would be more administratively burdensome as it 
would affect a larger number of CBSAs and rural areas as a transition 
wage index value for such areas would need to be used. Likewise, the 5 
percent cap on wage index decreases will help effectively mitigate any 
significant decreases in wage index values for CY 2021 for those HHAs 
in CBSAs where there would be decreases in the wage index due to the 
adoption of the new OMB delineations. Finally, we believe that it is 
important to remain consistent with the other Medicare payment systems 
such as Hospice, SNF, IRF and IPF where the 5 percent cap transition 
was finalized for FY 2021 to ensure consistency and parity in the wage 
index methodology used by Medicare.
    Comment: A few commenters, including MedPAC, suggested alternatives 
to the 5 percent cap transition policy. MedPAC suggested that the 5 
percent cap limit should apply to both increases and decreases in the 
wage index so that no provider would have its wage index value increase 
or decrease by more than 5 percent for CY 2021. A commenter suggested 
that wage index decreases should be capped at 3 percent instead of 5 
percent. Finally, several commenters recommended that CMS consider 
implementing a 5 percent cap, similar to that which we proposed for CY 
2021, for years beyond the implementation of the revised OMB 
delineations.
    Response: We appreciate MedPAC's suggestion that the cap on wage 
index changes of more than 5 percent should be applied to increases in 
the wage index. However, as we discussed in the proposed rule, the 
purpose of the proposed transition policy is to help mitigate the 
significant negative impacts of certain wage index changes. 
Additionally, we believe that the 5 percent cap on wage index decreases 
is an adequate safeguard against any significant payment reductions and 
do not believe that capping wage index decreases at 3 percent instead 
of 5 percent is appropriate. We believe that 5 percent is a reasonable 
level for the cap rather than 3 percent because it would more 
effectively mitigate any significant decreases in a home health 
agency's wage index for CY 2021, while still balancing the importance 
of ensuring that area wage index values accurately reflect relative 
differences in area wage levels. Furthermore, a 5 percent cap on wage 
index decreases in CY 2021 provides a degree of predictability in 
payment changes for providers and allows providers time to adjust to 
any significant decreases they may face in CY 2022, after the 
transition period has ended. Finally, with regards to the comments 
recommending that CMS consider implementing this type of transition in 
future years, we believe that this would be counter to the purpose of 
the wage index, which is used to adjust payments to account for local 
differences in area wage levels. While we believe that a transition is 
necessary to help mitigate the negative

[[Page 70312]]

impact from the revised OMB delineations in the first year of 
implementation, this transition must be balanced against the importance 
of ensuring accurate payments.
    Final Decision: We are finalizing our proposal to adopt the revised 
OMB delineations from the September 14, 2018 OMB Bulletin 18-04 and 
apply a 1-year 5 percent cap on wage index decreases as proposed, 
meaning the counties impacted will receive a 5 percent cap on any 
decrease in a geographic area's wage index value from the wage index 
value from the prior calendar year for CY 2021 effective January 1, 
2021.
    Due to the way that the transition wage index is calculated, some 
Core Based Statistical Areas (CBSAs) and statewide rural areas will 
have more than one wage index value associated with that CBSA or rural 
area. For example, some counties that change OMB designations will have 
a wage index value that is different than the wage index value 
associated with the CBSA or rural area they are moving to because of 
the transition. However, each county will have only one wage index 
value. For counties that correspond to a different transition wage 
index value, the CBSA number will not be able to be used for CY 2021 
claims. In these cases, a number other than the CBSA number will be 
needed to identify the appropriate wage index value for claims for home 
health care provided in CY 2021. These numbers are five digits in 
length and begin with ``50''. These special 50xxx codes are shown in 
the last column of the CY 2021 home health wage index file. For 
counties located in CBSAs and rural areas that do not correspond to a 
different transition wage index value, the CBSA number will still be 
used. More information regarding the counties that will receive the 
transition wage index will be provided in the Home Health Payment 
Update Change Request (CR) located at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2020-Transmittals.
    The final wage index applicable to CY 2021 can be found on the CMS 
website at: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center. The final HH PPS wage index for CY 2021 will be 
effective January 1, 2021 through December 31, 2021.
    The wage index file posted on the CMS website provides a crosswalk 
between each state and county and its corresponding wage index along 
with the previous CBSA number, the new CBSA number or alternate 
identification number, and the new CBSA name.

C. CY 2021 Home Health Payment Rate Updates

1. CY 2021 Home Health Market Basket Update for HHAs
    Section 1895(b)(3)(B) of the Act requires that the standard 
prospective payment amounts for CY 2021 be increased by a factor equal 
to the applicable home health market basket update for those HHAs that 
submit quality data as required by the Secretary. In the CY 2019 HH PPS 
final rule with comment period (83 FR 56425), we finalized a policy 
rebasing the home health market basket to reflect 2016 Medicare cost 
report (MCR) data, the latest available and complete data on the actual 
structure of HHA costs. As such, based on the rebased 2016-based home 
health market basket, we finalized our policy that the labor-related 
share will be 76.1 percent and the non-labor-related share is 23.9 
percent. A detailed description of how we rebased the HHA market basket 
is available in the CY 2019 HH PPS final rule with comment period (83 
FR 56425 through 56436).
    Section 1895(b)(3)(B) of the Act requires that in CY 2015 and in 
subsequent calendar years, except CY 2018 (under section 411(c) of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 
114-10, enacted April 16, 2015)), and CY 2020 (under section 53110 of 
the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted 
February 9, 2018)), the market basket percentage under the HHA 
prospective payment system, as described in section 1895(b)(3)(B) of 
the Act, be annually adjusted by changes in economy-wide productivity. 
Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity 
adjustment to be equal to the 10-year moving average of change in 
annual economy-wide private nonfarm business multifactor productivity 
(MFP) (as projected by the Secretary for the 10-year period ending with 
the applicable fiscal year, calendar year, cost reporting period, or 
other annual period) (the ``MFP adjustment''). The Bureau of Labor 
Statistics (BLS) is the agency that publishes the official measure of 
private nonfarm business MFP. Please visit http://www.bls.gov/mfp, to 
obtain the BLS historical published MFP data.
    Consistent with our historical practice and our proposal, we 
estimate the market basket increase and the MFP adjustment based on IHS 
Global Inc.'s (IGI) forecast using the most recent available data. In 
the CY 2021 HH PPS proposed rule (85 FR 39421), we proposed to 
establish a home health payment update percentage for CY 2021 of 2.7 
percent, based on the best available data at that time (that is, the 
estimated HHA market basket percentage increase of 3.1 percent, less 
the MFP adjustment of 0.4 percentage point). Consistent with our 
historical practice, we also proposed to use a more recent estimate of 
the home health market basket update and the MFP adjustment, if 
appropriate, to determine the home health payment update percentage for 
CY 2021 in the final rule.
    For this final rule based on IGI's third-quarter 2020 forecast 
(with historical data through second-quarter 2020), the home health 
market basket percentage increase for CY 2021 is, as specified at 
section 1895(b)(3)(B)(iii) of the Act, 2.3 percent. We note that the 
first quarter 2020 forecast used for the proposed home health market 
basket percentage increase was developed prior to the economic impacts 
of the COVID-19 PHE. This lower update (2.3 percent) for CY 2021, 
relative to the proposed rule (3.1 percent), is primarily driven by 
slower anticipated compensation growth for both health-related and 
other occupations as labor markets are expected to be significantly 
impacted during the recession that started in February 2020 and 
throughout the anticipated recovery. Compensation costs account for 76 
percent of the 2016-based HHA market basket and other labor-related 
costs account for an additional 12 percent of the 2016-based HHA market 
basket.
    The CY 2021 home health market basket percentage increase of 2.3 
percent is then reduced by a MFP adjustment, as mandated by the section 
3401 of the Patient Protection and Affordable Care Act (the Affordable 
Care Act) (Pub. L. 111-148). Based on the more recent data available 
for this final rule, the current estimate of the 10-year moving average 
growth of MFP for CY 2021 is 0.3 percentage points. This MFP is based 
on the most recent forecast of the macroeconomic outlook from IGI at 
the time of rulemaking (released September 2020) in order to reflect 
more current historical economic data. IGI produces monthly 
macroeconomic forecasts, which include projections of all of the 
economic series used to derive MFP. In contrast, IGI only produces 
forecasts of the more detailed price proxies used in the HHA market 
basket on a quarterly basis. Therefore, IGI's third quarter 2020 
forecast is the most recent forecast of the HHA market basket 
percentage increase.
    We note that it has typically been our practice to base the 
projection of the market basket price proxies and MFP in the final rule 
on the third quarter IGI forecast. For this final rule, we are using

[[Page 70313]]

the IGI September 2020 macroeconomic forecast for MFP because it is a 
more recent forecast, and it is important to use more recent data 
during this period when economic trends, particularly employment and 
labor productivity, are notably uncertain because of the COVID-19 PHE. 
However, we also note that the 10-year moving average of MFP based on 
the third quarter 2020 forecast is also 0.3 percentage points.
    Therefore, the final CY 2021 home health payment update percentage 
for CY 2021 is 2.0 percent (HHA market basket percentage increase of 
2.3 percent less 0.3 percentage points MFP adjustment). Section 
1895(b)(3)(B)(v) of the Act requires that the home health payment 
update percentage be decreased by 2.0 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 2021, the home 
health payment update percentage would be 0.0 percent (2.0 percent 
minus 2.0 percentage points).
    Comment: Nearly all commenters supported the proposed 2.7 percent 
increase for a market basket update. Several commenters stated concerns 
regarding additional costs of personal protective equipment (PPE) and 
other infection control measures due to the COVID-19 PHE, and 
recommended CMS to include a PPE cost add-on to the 2020 30-day period 
payment and per visit payment rates. Additionally, a few commenters 
requested to use the proposed 2.7 percent increase as a floor and urged 
CMS to not make any downward adjustments to the market basket in the 
final rule. Finally, a commenter recommended the same approach to the 
MFP adjustment as used in other rulemaking this year to more accurately 
capture the impacts of the COVID-19 PHE on economic productivity.
    Response: CMS thanks the commenters for their comments on the 
market basket percentage and appreciates their concerns regarding 
additional costs, such as PPE, due to the COVID-19 PHE. However, we do 
not yet have the claims and cost report data to conduct the analysis 
needed for a possible add-on payment to account for any increased costs 
for PPE. Historically, payments under the HH PPS have been higher than 
costs, and in its March 2020 Report to Congress, MedPAC estimates HHAs 
to have projected average Medicare margins of 17 percent in 2020.\4\ 
Therefore, it is anticipated that HHAs have sufficient payment to 
account for the costs of PPE. However, we can examine overall costs 
once we have complete claims and cost report data for CY 2020.
---------------------------------------------------------------------------

    \4\ Home Health Services, Chapter 9. MedPAC. March 2020. http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch9_sec.pdf.
---------------------------------------------------------------------------

    Consistent with our proposal and prior HHA PPS final rules, as well 
as other FY 2021 Medicare PPS final rules, we believe it is appropriate 
to determine the home health payment update percentage for CY 2021 for 
the final rule based on the most recent forecast (at the time of 
rulemaking) of the HHA market basket percentage increase and MFP 
adjustment.
    Final Decision: After consideration of public comments, CMS is 
finalizing the home health payment update percentage for CY 2021 based 
on the most recent forecast of the HHA market basket percentage 
increase and MFP adjustment at the time of rulemaking. Based on IGI's 
third-quarter 2020 forecast (with historical data through second-
quarter 2020) of the HHA market basket percentage increase and IGI's 
September 2020 macroeconomic forecast of MFP, the home health payment 
update percentage for CY 2021 will be 2.0 percent (2.3 percent HHA 
market basket percentage increase less 0.3 percentage point MFP 
adjustment) for HHAs that submit the required quality data and 0.0 
percent (2.0 percent minus 2.0 percentage points) for HHAs that do not 
submit quality data as required by the Secretary.
2. CY 2021 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 home health 
services. Since the inception of the HH PPS, we have used inpatient 
hospital wage data in developing a wage index to be applied to home 
health payments. We proposed to continue this practice for CY 2021, as 
we continue to believe that, in the absence of home health-specific 
wage data that accounts for area differences, using inpatient hospital 
wage data is appropriate and reasonable for the HH PPS. As discussed 
previously, we proposed to use the FY 2021 pre-floor, pre-reclassified 
hospital wage index with the September 2018 OMB delineations as the CY 
2021 wage adjustment to the labor portion of the HH PPS rates. For CY 
2021, the updated wage data are for hospital cost reporting periods 
beginning on or after October 1, 2016, and before October 1, 2017 (FY 
2017 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 2021 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. The most recent wage index 
previously available for rural Puerto Rico is 0.4047. 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 2021, the only urban area without inpatient hospital 
wage data is Hinesville, GA (CBSA 25980). The CY 2021 new delineations 
wage index value for Hinesville, GA is 0.8388.
    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 
OMB's area delineations using a 1-year transition.
    On August 15, 2017, OMB issued Bulletin No. 17-01 in which it 
announced that one Micropolitan Statistical Area, Twin Falls, Idaho, 
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300) 
comprises the principal city of Twin Falls, Idaho in Jerome County, 
Idaho and Twin Falls County, Idaho. The CY 2021 HH PPS wage index value 
for CBSA 46300, Twin Falls, Idaho, will be 0.8668. Bulletin No. 17-01 
is available at https://www.whitehouse.gov/sites/

[[Page 70314]]

whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.\5\
---------------------------------------------------------------------------

    \5\ ``Revised Delineations of Metropolitan Statistical Areas, 
Micropolitan Statistical Areas, and Combined Statistical Areas, and 
Guidance on Uses of the Delineations of These Areas''. OMB Bulletin 
No. 17-01. August 15, 2017. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
---------------------------------------------------------------------------

    On April 10, 2018 OMB issued OMB Bulletin No. 18-03 which 
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14, 
2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10, 
2018 OMB Bulletin No. 18-03. These bulletins established revised 
delineations for Metropolitan Statistical Areas, Micropolitan 
Statistical Areas, and Combined Statistical Areas, and provided 
guidance on the use of the delineations of these statistical areas. A 
copy of OMB Bulletin No. 18-04 may be obtained at https://www.whitehouse.gov/wpcontent/uploads/2018/09/Bulletin-18-04.pdf.
    As discussed previously the most recent OMB Bulletin (No. 20-01) 
was published on March 6, 2020 and is available at https://www.whitehouse.gov/wpcontent/uploads/2020/03/Bulletin-20-01.pdf. This 
bulletin was not available in time for development of the CY 2021 
proposed rule, however we will include any updates from OMB Bulletin 
No. 20-01 in future rulemaking.
    A summary of the general comments on the home health wage index and 
our responses to those comments are as follows:
    Comment: Many commenters recommended more far-reaching revisions 
and reforms to the wage index methodology used under Medicare fee-for-
service. A few commenters recommended a home health specific wage 
index. MedPAC recommended that Congress repeal the existing hospital 
wage index and instead implement a market-level wage index for use 
across the inpatient prospective payment system and other prospective 
payment systems, including certain post-acute care providers. A 
commenter recommended a home health floor similar to the floor used in 
hospice. Finally, a few commenters recommended that the home health 
wage index utilize geographic reclassification and a rural floor like 
the hospital wage index.
    Response: While we thank the commenters for their recommendations, 
these comments are outside the scope of the proposed rule. Any changes 
to the way we adjust home health payments to account for geographic 
wage differences, beyond the wage index proposals discussed in the CY 
2021 HH PPS proposed rule, would have to go through notice and comment 
rulemaking. While CMS and other stakeholders have explored potential 
alternatives to using OMB's statistical area definitions, no consensus 
has been achieved regarding how best to implement a replacement system. 
We believe that in the absence of home health specific wage data, using 
the pre-floor, pre-reclassified hospital wage data is appropriate and 
reasonable for home health payments. The reclassification provision at 
section 1886(d)(10)(C)(i) of the Act states that the Board shall 
consider the application of any subsection (d) hospital requesting the 
Secretary change the hospital's geographic classification. The 
reclassification provision found in section 1886(d)(10) of the Act is 
specific to IPPS hospitals only. Section 4410(a) of the Balanced Budget 
Act of 1997 (Pub. L. 105-33) 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 only specific to IPPS hospitals. Additionally, the 
application of the hospice floor is specific to hospices and does not 
apply to HHAs. The hospice floor was developed through a negotiated 
rulemaking advisory committee, under the process established by the 
Negotiated Rulemaking Act of 1990 (Pub. L. 101- 648). Committee members 
included representatives of national hospice associations; rural, 
urban, large, and small hospices; multi-site hospices; consumer groups; 
and a government representative. The Committee reached consensus on a 
methodology that resulted in the hospice wage index. Because the 
reclassification provision and the hospital rural floor applies only to 
hospitals, and the hospice floor applies only to hospices, we continue 
to believe the use of the pre-floor and pre-reclassified hospital wage 
index results in the most appropriate adjustment to the labor portion 
of the home health payment rates. This position is longstanding and 
consistent with other Medicare payment systems (for example, SNF PPS, 
IRF PPS, and Hospice).
    Final Decision: After considering the comments received in response 
to the proposed rule and for the reasons discussed previously, we are 
finalizing our proposal to use the FY 2021 pre-floor, pre-reclassified 
hospital wage index data as the basis for the CY 2021 HH PPS wage 
index. The final CY 2021 wage index is available on the CMS website at: 
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
3. CY 2021 Annual Payment Update
(a) Background
    The Medicare HH PPS has been in effect since October 1, 2000. As 
set forth in the July 3, 2000 final rule (65 FR 41128), the base unit 
of payment under the Medicare HH PPS was a national, standardized 60-
day episode payment rate. As finalized in the CY 2019 HH PPS final rule 
with comment period (83 FR 56406), and as described in the CY 2020 HH 
PPS final rule with comment period (84 FR 60478), the unit of home 
health payment changed from a 60-day episode to a 30-day period 
effective for those 30-day periods beginning on or after January 1, 
2020. As set forth in Sec.  484.220, we adjust the national, 
standardized prospective payment rates by a case-mix relative weight 
and a wage index value based on the site of service for the 
beneficiary. To provide appropriate adjustments to the proportion of 
the payment amount under the HH PPS to account for area wage 
differences, we apply the appropriate wage index value to the labor 
portion of the HH PPS rates. In the CY 2019 HH PPS final rule with 
comment period (83 FR 56435), we finalized rebasing the home health 
market basket to reflect 2016 MCR data, the latest available and most 
complete data on the actual structure of HHA costs. We also finalized a 
revision to the labor-related share to reflect the 2016-based home 
health market basket compensation (Wages and Salaries plus Benefits) 
cost weight. We finalized that for CY 2019 and subsequent years, the 
labor-related share would be 76.1 percent and the non-labor-related 
share would be 23.9 percent. The following are the steps we take to 
compute the case-mix and wage-adjusted 30-day period rates for CY 2021:
     Multiply the national, standardized 30-day period rate by 
the patient's applicable case-mix weight.
     Divide the case-mix adjusted amount into a labor (76.1 
percent) and a non-labor portion (23.9 percent).
     Multiply the labor portion by the applicable wage index 
based on the site of service of the beneficiary.
     Add the wage-adjusted portion to the non-labor portion, 
yielding the case-mix and wage adjusted 30-day period rate, subject to 
any additional applicable adjustments.
    We provide annual updates of the HH PPS rate in accordance with 
section 1895(b)(3)(B) of the Act. Section 484.225

[[Page 70315]]

sets forth the specific annual percentage update methodology. In 
accordance with section 1895(b)(3)(B)(v) of the Act and Sec.  
484.225(c), for an HHA that does not submit home health quality data, 
as specified by the Secretary, the unadjusted national prospective 30-
day period rate is equal to the rate for the previous calendar year 
increased by the applicable home health payment update, minus 2 
percentage points. Any reduction of the percentage change would apply 
only to the calendar year involved and would not be considered in 
computing the prospective payment amount for a subsequent calendar 
year.
    The final claim that the HHA submits for payment determines the 
total payment amount for the period and whether we make an applicable 
adjustment to the 30-day case-mix and wage-adjusted payment amount. The 
end date of the 30-day period, as reported on the claim, determines 
which calendar year rates Medicare will use to pay the claim.
    We may adjust a 30-day case-mix and wage-adjusted payment based on 
the information submitted on the claim to reflect the following:
     A low-utilization payment adjustment (LUPA) is provided on 
a per-visit basis as set forth in Sec. Sec.  484.205(d)(1) and 484.230.
     A partial payment adjustment as set forth in Sec. Sec.  
484.205(d)(2) and 484.235.
     An outlier payment as set forth in Sec. Sec.  
484.205(d)(3) and 484.240.
(b) CY 2021 National, Standardized 30-Day period Payment Amount
    Section 1895(b)(3)(D)(i) of the Act, as added by section 
51001(a)(2)(B) of the BBA of 2018, requires us to analyze data for CYs 
2020 through 2026, after implementation of the 30-day unit of payment 
and new PDGM case-mix adjustment methodology, to annually determine the 
impact of the differences between assumed behavior changes and actual 
behavior changes on estimated aggregate expenditures. In the CY 2021 HH 
PPS proposed rule, we stated that we would continue to monitor the 
impact of these changes on patient outcomes and Medicare expenditures, 
but that we believed it would be premature to release any information 
related to these issues based on the amount of data currently available 
and in light of the COVID-19 PHE. Therefore, for CY 2021, we did not 
propose to make any additional changes to the national, standardized 
30-day period payment rate other than the routine rate updates outlined 
in the proposed rule. We stated that in future rulemaking, we plan to 
determine whether any changes need to be made to the national, 
standardized 30-day period payment rate based on the analysis of the 
actual versus assumed behavior change.
    Section 1895(b)(3)(A)(i) of the Act requires that the standard 
prospective payment rate and other applicable amounts be standardized 
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a 
budget-neutral manner. To determine the CY 2021 national, standardized 
30-day period payment rate, we apply a wage index budget neutrality 
factor and the home health payment update percentage discussed in 
section III.C.2. of this final rule.
    To calculate the wage index budget neutrality factor, we simulated 
total payments, using CY 2019 Medicare claims data for episodes ending 
on or before December 31, 2019 for which we had a linked OASIS 
assessment, for non-LUPA 30-day periods using the CY 2021 wage index 
and compared it to our simulation of total payments for non-LUPA 30-day 
periods using the CY 2020 wage index. By dividing the total payments 
for non-LUPA 30-day periods using the CY 2021 wage index by the total 
payments for non-LUPA 30-day periods using the CY 2020 wage index, we 
obtain a wage index budget neutrality factor of 0.9999. We apply the 
wage index budget neutrality factor of 0.9999 to the calculation of the 
CY 2021 national, standardized 30-day period payment rate.
    We note that in past years, a case-mix budget neutrality factor was 
annually applied to the HH PPS base rates to account for the change 
between the previous year's case-mix weights and the newly recalibrated 
case-mix weights. Since CY 2020 was the first year of PDGM, we did not 
propose to recalibrate the PDGM case-mix weights and; therefore, a 
case-mix budget neutrality factor is not needed. However, in future 
years under the PDGM, we would apply a case-mix budget neutrality 
factor with the annual payment update in order to account for the 
change between the previous year's PDGM case-mix weights and the new 
recalibrated PDGM case-mix weights.
    Next, we update the 30-day payment rate by the CY 2021 home health 
payment update percentage of 2.0 percent. The CY 2021 national, 
standardized 30-day period payment rate is calculated in Table 7.
[GRAPHIC] [TIFF OMITTED] TR04NO20.007

    The CY 2021 national, standardized 30-day period payment rate for 
an HHA that does not submit the required quality data is updated by the 
CY 2021 home health payment update of 2.0 percent minus 2 percentage 
points and is shown in Table 8.

[[Page 70316]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.008

    Comments regarding the update to the CY 2021 national, standardized 
30-day period payment amount are summarized in this section of this 
final rule. In addition, although we did not propose any changes the 
national, standardized 30-day period payment rate for CY 2021, except 
for the statutorily-required routine payment rate update, we received 
numerous comments regarding the behavior assumptions adjustment and 
these are summarized in this section of this final rule.
    Comment: Commenters generally supported the home health payment 
updates for CY 2021. MedPAC stated that it recognizes that the public 
health emergency has had an effect on the home health benefit and will 
continue to monitor its effects, but still felt that many HHAs have 
been able to mitigate the negative impacts of the public health 
emergency through various mechanisms, including accessing funds through 
the Payroll Protection Program. MedPAC reiterated its recommendation 
from its March 2020 report to the Congress to reduce home health 
payments by 7 percent in CY 2021.
    Response: Section 1895(b)(3)(B) of the Act requires that the 
standard prospective payment amounts for CY 2021 be increased by a 
factor equal to the applicable home health market basket percentage 
increase reduced by the MFP adjustment, and as such, we have no 
statutory or regulatory discretion in this matter.
    Comment: Several commenters recommended that CMS reduce or 
eliminate the 4.36 percent behavior assumption reduction, finalized in 
the CY 2020 HH PPS final rule with comment period (84 FR 60511-60519)), 
to the national, standardized 30-day period payment rate for the 
remainder of CY 2020 and for CY 2021 rate setting. Commenters stated 
that the effects of the COVID-19 PHE, in tandem with a new home health 
payment system, has brought about changes in patient mix, decreased 
utilization of home health services, and changing demands from patients 
in need of care. These commenters stated that the impact on payment to 
home health agencies would make it highly unlikely that Medicare home 
health spending in CY 2020 would be budget neutral in comparison to the 
level of spending that would have occurred if the PDGM and the change 
to a 30-day unit of payment had not been implemented.
    Response: We thank the commenters for their recommendations and 
while we did not propose any changes for CY 2021 relating to the 
behavior assumptions finalized in the CY 2019 HH PPS final rule with 
comment period (84 FR 56461), or to the 4.36 percent behavior 
assumption reduction, finalized in the CY 2020 HH PPS final rule with 
comment period (84 FR 60519), we want to respond with what CMS is 
required to do by law. Under section 1895(b)(3)(A)(iv) of the Act, we 
were 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 would be equal to the estimated aggregate 
expenditures that otherwise would have been made under the HH PPS 
during CY 2020 in the absence of the change to a 30-day unit of 
payment. Section 1895(b)(3)(A)(iv) of the Act also required that in 
calculating a 30-day payment amount in a budget-neutral manner the 
Secretary must make assumptions about behavior changes that could occur 
as a result of the implementation of the 30-day unit of payment and the 
case-mix adjustment factors established under 1895(b)(4)(B) of the Act. 
We were also required to calculate a budget-neutral 30-day payment 
amount before the provisions of section 1895(b)(3)(B) of the Act were 
applied; that is, before the home health applicable percentage 
increase, the adjustment if quality data are not reported, and the 
productivity adjustment.
    In the CY 2020 HH PPS final rule with comment period, we stated 
that applying the previously finalized clinical group and comorbidity 
coding assumptions, and the LUPA threshold assumption, as required by 
section 1895(b)(3)(A)(iv) of the Act, would result in the need to 
decrease the CY 2020 30-day payment amount by 8.389 percent to maintain 
budget neutrality. However, commenters stated that CMS overestimated 
the magnitude of the behavior changes that would occur as HHAs 
transitioned to a new case-mix methodology and a change to a 30-day 
unit of payment. Commenters stated that behavior change would not occur 
100 percent of the time for all 30-day periods of care. Therefore, in 
response to comments as to the frequency of the assumed behaviors 
during the first year of the transition to a new unit of payment and 
case-mix adjustment methodology, we finalized to apply the three 
behavior change assumptions, as finalized in the CY 2019 HH PPS final 
rule with comment period, to only half of the 30-day periods for 
purposes of calculating the CY 2020 30-day payment rate. As such, in 
the CY 2020 HH PPS final rule with comment period, we finalized a x4.36 
percent behavior assumption adjustment in order to calculate the 30-day 
payment rate in a budget-neutral manner for CY 2020 (84 FR 60511-
60519).
    Additionally, section 1895(b)(3)(D) of the Act requires the 
Secretary to analyze data for CYs 2020 through 2026, after 
implementation of the 30-day unit of payment and new case-mix 
adjustment methodology under the PDGM, to annually determine the impact 
of the differences between assumed and actual behavior changes on 
estimated aggregate expenditures and, at a time and manner determined 
appropriate by the Secretary, make permanent and temporary adjustments 
to the 30-day payment amounts. This means that if CMS underestimates 
the reductions to the 30-day payment amount necessary to offset 
behavior changes and maintain budget neutrality, larger adjustments to 
the 30-day payment amount would be required in the future to ensure 
budget neutrality. Likewise, if CMS overestimates the reductions, we 
are required to make the appropriate payment adjustments accordingly. 
In the CY 2019 HH PPS final rule with

[[Page 70317]]

comment period (83 FR 56459), we stated that 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 same would 
hold true for any decreases in the number of beneficiaries utilizing 
Medicare home health services. That is to say, the law required that 
CMS calculate the 30-day payment amount for CY 2020 to ensure that the 
aggregate expenditures during CY 2020 under the new case-mix 
methodology and 30-day unit of payment would be the same as if the 153-
group model was still in place in CY 2020. Therefore, any future 
payment adjustment required by section 1895(b)(3)(D) of the Act, must 
be based on the difference in aggregate payments between the assumed 
versus actual behavior change and not because of utilization changes 
resulting from the COVID-19 PHE. However, CMS issued several IFCs, as 
described throughout this final rule, to provide flexibilities to 
ensure that HHAs could provide care to Medicare beneficiaries in the 
least burdensome manner during the COVID-19 PHE. These flexibilities 
include:
     Allowing HHAs to provide more services to beneficiaries 
using telecommunications technology within the 30-day period of care, 
so long as it's part of the patient's plan of care and does not replace 
needed in-person visits as ordered on the plan of care;
     Allowing the face-to-face encounter for home health to be 
conducted via telehealth (i.e., 2-way audio-video telecommunications 
technology);
     Extending the 5-day completion requirement for the 
comprehensive assessment to 30 days;
     Waiving the 30-day OASIS submission requirement (though 
HHAs must submit OASIS data prior to submitting their final claim in 
order to receive Medicare payment);
     Waiving the requirements in 42 CFR 484.55(a)(2) and Sec.  
484.55(b)(3) that rehabilitation skilled professionals may only perform 
the initial and comprehensive assessment when only therapy services are 
ordered; and
     Changing the home health regulations to include physician 
assistants, nurse practitioners, and clinical nurse specialists as 
individuals who can certify the need for home health services and order 
services.
    These flexibilities were provided to help mitigate commenters' 
concerns about the provision of home health services during the COVID-
19 PHE. Moreover, as we stated in the CY 2021 HH PPS proposed rule, we 
believed it would be premature to propose any changes to the CY 2021 
payment rate based on the data available at the time of CY 2021 
rulemaking and in light of the ongoing COVID-19 PHE. Finally, any 
changes to the national, standardized 30-day period payment rates to 
account for differences in assumed versus actual behavior change are 
required to go through notice and comment rulemaking, as required by 
1895(b)(3)(D)(ii) and (iii) of the Act.
    Comment: Several commenters stated that the first eight months of 
the PDGM cannot be understood as an accurate representation of the new 
payment model given the public health emergency. These commenters 
stated that the short and long-term effects are not yet fully known and 
therefore, there should be no changes to the payment system for CY 
2021.
    Response: We thank commenters for their recommendation and we did 
not propose any changes to the home health prospective payment system, 
other than the routine payment updates, for CY 2021.
(c) CY 2021 National Per-Visit Rates for 30-Day Periods of Care
    The national per-visit rates are used to pay LUPAs and are also 
used to compute imputed costs in outlier calculations. The per-visit 
rates are paid by type of visit or home health discipline. The six home 
health 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 2021 national per-visit rates, we started with 
the CY 2020 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 30-day periods of care using the CY 
2021 wage index and comparing it to simulated total payments for LUPA 
30-day periods using the CY 2020 wage index. By dividing the total 
payments for LUPA 30-day periods using the CY 2021 wage index by the 
total payments for LUPA 30-day periods using the CY 2020 wage index, we 
obtained a wage index budget neutrality factor of 0.9997. Lastly, the 
per-visit rates for each discipline are updated by the CY 2021 home 
health payment update percentage of 2.0 percent. The LUPA per-visit 
rates are not calculated using case-mix weights. Therefore, no case-mix 
weight budget neutrality factor is needed to ensure budget neutrality 
for LUPA payments.
    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 30-day periods that occur as the only 30-day period or the initial 
period in a sequence of adjacent 30-day periods. The CY 2021 national 
per-visit rates for HHAs that submit the required quality data are 
shown in Table 9.
[GRAPHIC] [TIFF OMITTED] TR04NO20.009


[[Page 70318]]


    The CY 2021 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the CY 2020 home health payment 
update percentage of 2.0 percent minus 2.0 percentage points and are 
shown in Table 10.
[GRAPHIC] [TIFF OMITTED] TR04NO20.010

    In the CY 2021 HH PPS proposed rule (85 FR 39424), we reminded 
stakeholders of the policies finalized in the CY 2020 HH PPS final rule 
with comment (84 FR 60544) with regards to the submission of Requests 
for Anticipated Payment (RAPs) for CY 2021 and the implementation of a 
new one-time Notice of Admission (NOA) process starting in CY 2022. In 
that final rule, we finalized the reduction in up-front payment made in 
response to a RAP to zero percent for all 30-day periods of care 
beginning on or after January 1, 2021 (84 FR 60544). For CY 2021, all 
HHAs (both existing and newly-enrolled HHAs) will submit a RAP at the 
beginning of each 30-day period to establish the home health period of 
care in the common working file and also to trigger the consolidated 
billing edits. With the removal of the upfront RAP payment for CY 2021, 
we relaxed the required information for submitting the RAP for CY 2021 
and stated that the information required for submitting an NOA for CYs 
2022 and subsequent years would mirror that of the RAP in CY 2021. 
Starting in CY 2022, HHAs will submit a one-time NOA that establishes 
the home health period of care and covers all contiguous 30-day periods 
of care until the individual is discharged from Medicare home health 
services. In addition, for both the submission of the RAP in CY 2021 
and the one-time NOA for CYs 2022 and subsequent years, we finalized a 
payment reduction if the HHA does not submit the RAP for CY 2021 or NOA 
for CYs 2022 and subsequent years within 5 calendar days from the start 
of care. That is, if an HHA fails to submit a timely RAP for CY 2021 or 
fails to submit a timely NOA for CYs 2022 and subsequent years, the 
reduction in payment amount would be equal to a one-thirtieth reduction 
to the wage and case-mix adjusted 30-day period payment amount for each 
day from the home health start of care date until the date the HHA 
submitted the RAP or NOA. In other words, the one-thirtieth reduction 
would be to the 30-day period adjusted payment amount, including any 
outlier payment, that the HHA otherwise would have received absent any 
reduction. For LUPA 30-day periods of care in which an HHA fails to 
submit a timely RAP or NOA, no LUPA payments would be made for days 
that fall within the period of care prior to the submission of the RAP 
or NOA. We stated that these days would be a provider liability, the 
payment reduction could not exceed the total payment of the claim, and 
that the provider may not bill the beneficiary for these days. For more 
in-depth information regarding the finalized policies associated with 
RAPs and the new one-time NOA process, we refer readers to the CY 2020 
HH PPS final rule with comment (84 FR 60544).
    Though we did not solicit comments on the previously finalized 
split percentage payment approach for CY 2021 or the NOA process for CY 
2022, we did receive several comments on various components of the 
finalized policy. While most of the comments were out of scope of the 
proposed rule because we did not propose to make any changes, we did 
receive a few technical comments regarding the implementation of the 
finalized policy, which are summarized in this section of this final 
rule.
    Comment: A commenter requested clarification on the methodology 
used to calculate the non-timely submission payment reduction. This 
commenter asked whether the reduction begins on day 1 or day 6. Another 
commenter recommended an alternative to the non-timely submission 
payment reduction. This commenter recommended that no RAP/NOA be 
considered late until day 6 of the 30-day period. The commenter 
suggested making the reduction one 25th for each day that it is late 
beyond day 5 (days 6-30).
    Response: For purposes of determining if a ``no-pay'' RAP is 
timely-filed, the ``no-pay'' RAP must be submitted within 5 calendar 
days after the start of each 30-day period of care. For example, if the 
start of care for the first 30-day period is January 1, 2021, the ``no-
pay'' RAP would be considered timely-filed if it is submitted on or 
before January 6, 2021.
    Example:

1/1/2021 = Day 0 (start of the first 30-day period of care)
1/6/2021 = Day 5 (A ``no-pay'' RAP submitted on or before this date 
would be considered ``timely-filed''.)
1/7/2021 and after = Day 6 and beyond (A ``no-pay'' RAP submitted on 
and after this date will trigger the penalty.)

    In the event that the ``no-pay'' RAP is not timely-filed, the 
penalty is calculated from the first day of that 30-day period (in the 
example, the penalty calculation would begin with the start of care 
date of January 1, 2021, counting as the first day of the penalty) 
until the date of the submission of the ``no-pay''

[[Page 70319]]

RAP. As finalized in the CY 2020 HH PPS final rule with comment period, 
Medicare does not pay for those days of home health services based on 
the ``from date'' on the claim to the date of filing of the RAP. 
Therefore, in CY 2021, the wage and case-mix adjusted 30-day payment 
amount is reduced by 1/30th for each day from the home health based on 
the ``from date'' on the claim until the date of filing of the RAP. For 
example, if an HHA submits their ``no-pay'' RAP one day late (with a 
submission 6 days after the start of care), the result would be a 20 
percent reduction to the 30-day payment amount. Additionally, the 
finalized policy states that no LUPA payments are made that fall within 
the late period; the payment reduction cannot exceed the total payment 
of the claim; the non-covered days are a provider liability; and the 
provider must not bill the beneficiary for the non-covered days. And 
finally, in the CY 2020 HH PPS final rule with comment period (84 FR 
60546), we stated that the ``no-pay'' RAP submission in CY 2021 and the 
NOA process beginning in CY 2022 would be similar to the hospice Notice 
of Election (NOE) process and where the penalty is calculated beginning 
with the start of care date. Therefore, we do not believe that the 
penalty calculation should begin on day 6 as the commenters 
recommended.
    Comment: A few commenters provided several scenarios in which the 
HHA believed that the patient was covered under Medicare Advantage or 
another payer only to find out that the patient was actually covered 
under traditional Medicare and this could create a situation in which 
the RAP submission would be submitted after the timely-filing 
requirement. A commenter stated that agencies struggle with 
ascertaining beneficiary eligibility against inaccurate information in 
the Common Working File (CWF) as there can be significant lag time 
between a beneficiary's enrollment/disenrollment date and CWF update 
and that several days can pass before the plan provides any eligibility 
and/or authorization information on the beneficiary. Therefore, the 
commenter is concerned that agencies could be at risk for missing the 
5-day window while seeking to confirm a beneficiary's insurance 
coverage. These commenters asked if there would be claim payment 
penalties for the periods that are being updated and re-billed to 
reflect the retroactive enrollment in Original Medicare.
    Response: In the CY 2020 HH PP final rule with comment period, we 
finalized exceptions to the timely filing consequences of the RAP 
requirements at Sec.  484.205(g)(4). Specifically, we finalized that 
CMS may waive the consequences of failure to submit a timely-filed RAP 
if it is determined that a circumstance encountered by a home health 
agency is exceptional and qualifies for waiver of the consequence. As 
finalized in the CY 2020 HH PPS final rule with comment period and as 
set forth in regulation at Sec.  484.205(g)(4), an exceptional 
circumstance may be due to, but is not limited to the following:
     Fires, floods, earthquakes, or similar unusual events that 
inflict extensive damage to the home health agency's ability to 
operate.
     A CMS or Medicare contractor systems issue that is beyond 
the control of the home health agency.
     A newly Medicare-certified home health agency that is 
notified of that certification after the Medicare certification date, 
or which is awaiting its user ID from its Medicare contractor.
     Other situations determined by CMS to be beyond the 
control of the home health agency.
    If an HHA believes that there is a circumstance that may qualify 
for an exception, the home health agency must fully document and 
furnish any requested documentation to CMS for a determination of 
exception. The scenarios provided by commenters may fall into one of 
the established timely filing exceptions.
(d) Low-Utilization Payment Adjustment (LUPA) Add-On Factors
    Prior to the implementation of the 30-day unit of payment, LUPA 
episodes were eligible for a LUPA add-on payment if the episode of care 
was the first or only episode in a sequence of adjacent episodes. As 
stated in the CY 2008 HH PPS final rule, we stated that 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 occurred as the only episode or as an initial 
episode in a sequence of adjacent episodes were adjusted by applying an 
additional amount to the LUPA payment before adjusting for area wage 
differences. In the CY 2014 HH PPS final rule (78 FR 72305), we changed 
the methodology for calculating the LUPA add-on amount by finalizing 
the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and 
1.6266 for SLP. We multiply the per-visit payment amount for the first 
SN, PT, or SLP visit in LUPA episodes that occur as the only episode or 
an initial episode in a sequence of adjacent episodes by the 
appropriate factor to determine the LUPA add-on payment amount.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56440), 
in addition to finalizing a 30-day unit of payment, we finalized our 
policy of continuing to multiply the per-visit payment amount for the 
first skilled nursing, physical therapy, or speech-language pathology 
visit in LUPA periods that occur as the only 30-day period of care or 
the initial 30-day period of care in a sequence of adjacent 30-day 
periods of care by the appropriate add-on factor (1.8451 for SN, 1.6700 
for PT, and 1.6266 for SLP) to determine the LUPA add-on payment amount 
for 30-day periods of care under the PDGM. For example, using the 
finalized CY 2021 per-visit payment rates for those HHAs that submit 
the required quality data, for LUPA periods that occur as the only 
period or an initial period in a sequence of adjacent periods, if the 
first skilled visit is SN, the payment for that visit would be $281.62 
(1.8451 multiplied by $152.63), subject to area wage adjustment. We did 
not receive any comments on the LUPA add-on factors.
    Final Decision: After considering the comments received in response 
to the proposed CY 2021 annual payment update and for the reasons 
discussed previously, we are finalizing the CY 2021 national, 
standardized 30-day payment rates, the per-visit payment rates and the 
home health payment update percentage of 2.0 percent for CY 2021 as 
proposed. We are not making any changes to the policies previously 
finalized in the CY 2020 HH PPS final rule regarding the behavior 
assumptions adjustment. In accordance with section 1895(b)(3)(D) of the 
Act, we will analyze data for CYs 2020 through 2026, after 
implementation of the 30-day unit of payment and new case-mix 
adjustment methodology under the PDGM, to annually determine the impact 
of the differences between assumed and actual behavior changes on 
estimated aggregate expenditures and, at a time and manner determined 
appropriate by the Secretary, make permanent and temporary adjustments 
to the 30-day payment amounts. Any future changes to the national, 
standardized 30-day period payment rates to account for differences in 
assumed versus actual behavior change, as a result of the 
implementation of the 30-day unit of payment and the case-mix 
adjustment methodology under the PDGM, are required to go through 
notice and comment rulemaking as required by 1895(b)(3)(D)(ii) and 
(iii) of the Act. We are not making any changes to the split-percentage 
payment policy finalized in the CY 2020 HH PPS final rule. That is,

[[Page 70320]]

for CY 2021, all HHAs will submit a ``no-pay'' RAP at the beginning of 
each 30-day period to allow the beneficiary to be claimed in the CWF 
and also to trigger the consolidated billing edits.

D. Rural Add-On Payments for CY 2021 and CY 2022

1. Background
    Section 421(a) of the Medicare Prescription Drug Improvement and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) required, for home 
health services furnished in a rural area (as defined in section 
1886(d)(2)(D) of the Act), for episodes or visits ending on or after 
April 1, 2004, and before April 1, 2005, that the Secretary increase 
the payment amount that otherwise would have been made under section 
1895 of the Act for the services by 5 percent. Section 5201 of the 
Deficit Reduction Act of 2003 (DRA) (Pub. L. 108-171) amended section 
421(a) of the MMA. The amended section 421(a) of the MMA required, for 
home health 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 home health 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 home health services provided in a rural area (as defined in 
section 1886(d)(2)(D) of the Act), for episodes and visits ending 
before January 1, 2018.
    Section 50208(a) of the BBA of 2018 amended section 421(a) of the 
MMA to extend the rural add-on by providing an increase of 3 percent of 
the payment amount otherwise made under section 1895 of the Act for 
home health 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 CY 2022
    Section 50208(a)(1)(D) of the BBA of 2018 added a new subsection 
(b) to section 421 of the MMA to provide rural add-on payments for 
episodes or visits ending during CYs 2019 through 2022. It also 
mandated implementation of a new methodology for applying those 
payments. Unlike previous rural add-ons, which were applied to all 
rural areas uniformly, the extension provided varying add-on amounts 
depending on the rural county (or equivalent area) classification by 
classifying each rural county (or equivalent area) into one of three 
distinct categories: (1) Rural counties and equivalent areas in the 
highest quartile of all counties and equivalent areas based on the 
number of Medicare home health episodes furnished per 100 individuals 
who are entitled to, or enrolled for, benefits under Part A of Medicare 
or enrolled for benefits under Part B of Medicare only, but not 
enrolled in a Medicare Advantage plan under Part C of Medicare (the 
``High utilization'' category); (2) rural counties and equivalent areas 
with a population density of 6 individuals or fewer per square mile of 
land area and are not included in the ``High utilization'' category 
(the ``Low population density'' category); and (3) rural counties and 
equivalent areas not in either the ``High utilization'' or ``Low 
population density'' categories (the ``All other'' category).
    In the CY 2019 HH PPS final rule with comment period (83 FR 56443), 
CMS finalized policies for the rural add-on payments for CY 2019 
through CY 2022, in accordance with section 50208 of the BBA of 2018. 
The CY 2019 HH PPS proposed rule (83 FR 32373) described the provisions 
of the rural add-on payments, the methodology for applying the new 
payments, and outlined how we categorized rural counties (or equivalent 
areas) based on claims data, the Medicare Beneficiary Summary File and 
Census data. The data used to categorize each county or equivalent area 
is available in the Downloads section associated with the publication 
of this rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file containing the 
rural county or equivalent area name, their Federal Information 
Processing Standards (FIPS) state and county codes, and their 
designation into one of the three rural add-on categories is available 
for download.
    The HH PRICER module, located within CMS' claims processing system, 
will increase the CY 2021 30-day base payment rates, described in 
section III.C.3.b. of this final rule, by the appropriate rural add-on 
percentage prior to applying any case-mix and wage index adjustments. 
The CY 2019 through CY 2022 rural add-on percentages outlined in law 
are shown in Table 11.
[GRAPHIC] [TIFF OMITTED] TR04NO20.011

    Though we did not make any proposals regarding the rural add-on 
percentages in the CY 2021 HH PPS proposed rule, we did receive some 
comments as summarized in this section of this final rule.
    Comment: While commenters understood the rural add-on payments 
decrease has been mandated by the BBA of 2018, many expressed continued 
concern and frustration of the reduction in support for access to rural 
beneficiaries. Several requested for stakeholders and CMS to work 
together with Congress to establish legislation to extend the 3 percent 
rural add-on payment. A few commenters recommended to continue 
monitoring utilization during the post-implementation period and to 
extend or modify the rural add-on as necessary. Some commenters had 
specific concerns about HHAs serving patients that reside in counties 
in the rural add-on high utilization category and such category losing 
its rural add-on payment in CY 2021. A commenter had concerns

[[Page 70321]]

regarding the change in the OMB delineations and how the new CBSA re-
designation would affect any rural add-on payments. Specifically, the 
commenter asked if a rural add-on payment would be paid in CY 2021 if 
an HHA changed from an urban to a rural CBSA and whether the rural add-
on payment would no longer be paid if an HHA changed from a rural to an 
urban CBSA in CY 2021 based on the new OMB delineations. A few 
commenters expressed support for the proposed rural add-on payment for 
CY 2021 and the methodology used to implement Section 50208 of the BBA 
of 2018, but recommended that CMS work with both stakeholders and 
Congress on long-term solutions for rural safeguards, given the cost 
and population health differences in rural America. Finally, a 
commenter recommended that, with the sunset of the rural add-on 
payment, CMS should include telehealth or virtual visits as a billable 
visit to help offset the financial burden of rural HHAs.
    Response: We thank commenters for their recommendations. We 
understand commenter concerns about the phase-out of rural add-on 
payments and potential effects on rural HHAs. However, because the 
current rural add-on policy is statutory, we have no regulatory 
discretion to modify or extend it. However, CMS will continue to 
monitor patient access to home health services and the costs associated 
with providing home health care in rural versus urban areas. In 
response to the comment regarding the new OMB delineations and the 
potential effect on the rural add-on payment, section 50208(a)(1)(D) of 
the BBA of 2018 (revising section 421 of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)) 
states that the designation for the rural add-on payment shall be made 
a single time and shall apply for the duration of the period to which 
the subsection applies. That is to say, that each county had a one-time 
designation as described CY 2019 HH PPS final rule with comment period 
(83 FR 56443) and the rural add-on payment is made based on that 
designation regardless of any change in CBSA status based on the new 
OMB delineations. In response to comments regarding the inclusion of 
telehealth services as billable visits, we refer readers to section 
III.F. of this final rule for a summary of comments and our responses 
on the use of telecommunications technology under the Medicare home 
health benefit.
    Final Decision: Policies for the provision of rural add-on payments 
for CY 2019 through CY 2022 were finalized in the CY 2019 HH PPS final 
rule with comment period (83 FR 56443), in accordance with section 
50208 of the BBA of 2018. The data used to categorize each county or 
equivalent area are available in the downloads section associated with 
the publication of this rule at: https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file 
containing the rural county or equivalent area name, their Federal 
Information Processing Standards (FIPS) state and county codes, and 
their designation into one of the three rural add-on categories is 
available for download.

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 home health FDL ratio 
by a case's wage-adjusted national, standardized 60-day episode payment 
rate, which yields an FDL dollar amount for the case. The outlier 
threshold amount is the sum of the wage and case-mix adjusted PPS 
episode amount and wage-adjusted FDL amount. The outlier payment is 
defined to be a proportion of the wage-adjusted estimated cost that 
surpasses the wage-adjusted threshold. The proportion of additional 
costs over the outlier threshold amount paid as outlier payments is 
referred to as the loss-sharing ratio.
    As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 
70399), section 3131(b)(1) of the Affordable Care Act amended section 
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH 
PPS payment rates such that aggregate HH PPS payments were reduced by 5 
percent. In addition, section 3131(b)(2) of the Affordable Care Act 
amended section 1895(b)(5) of the Act by 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 for each year at 10 percent.
    As such, beginning in CY 2011, we reduced payment rates by 5 
percent and targeted up to 2.5 percent of total estimated HH PPS 
payments to be paid as outliers. To do so, we first returned the 2.5 
percent held for the target CY 2010 outlier pool to the national, 
standardized 60-day episode rates, the national per visit rates, the 
LUPA add-on payment amount, and the NRS conversion factor for CY 2010. 
We then reduced the rates by 5 percent as required by section 
1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the 
Affordable Care Act. For CY 2011 and subsequent calendar years we 
targeted up to 2.5 percent of estimated total payments to be paid as 
outlier payments, and apply a 10-percent agency-level outlier cap.
    In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 
43742 and 81 FR 76702), we described our concerns regarding patterns 
observed in home health outlier episodes. Specifically, we noted that 
the methodology for calculating home health outlier payments may have 
created a financial incentive for providers to increase the number of 
visits during an episode of care in order to surpass the outlier 
threshold; and simultaneously created a disincentive for providers to 
treat medically complex beneficiaries who require fewer but longer 
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 
76702), we finalized changes to the methodology used to calculate 
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate 
payment for outlier episodes, accounting for both the number of visits 
during an episode of care and also the length of the visits provided. 
Using this approach, we now convert the national per-visit rates into 
per 15-minute unit rates. These per 15-minute unit rates are used to 
calculate the estimated cost of an episode to determine whether the 
claim will receive an outlier payment and the

[[Page 70322]]

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 will publish the cost-per-unit amounts for CY 2021 in the rate 
update change request, which is issued after the publication of the CY 
2021 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 payment update percentage each year, 
meaning we would start with the national per visit amounts for the same 
calendar year when calculating the cost-per-unit used to determine the 
cost of an episode of care (81 FR 76727). We note that we will continue 
to monitor the visit length by discipline as more recent data become 
available, and we may propose to update the rates as needed in the 
future.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56521), 
we finalized a policy to maintain the current methodology for payment 
of high-cost outliers upon implementation of the PDGM beginning in CY 
2020 and that we will calculate payment for high-cost outliers based 
upon 30-day periods of care.
2. Fixed Dollar Loss (FDL) Ratio for CY 2021
    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 periods that can receive outlier 
payments, but makes it possible to select a higher loss-sharing ratio, 
and therefore, increase outlier payments for qualifying outlier 
periods. Alternatively, a lower FDL ratio means that more periods can 
qualify for outlier payments, but outlier payments per period must then 
be lower.
    The FDL ratio and the loss-sharing ratio must be selected so that 
the estimated total outlier payments do not exceed the 2.5 percent 
aggregate level (as required by section 1895(b)(5)(A) of the Act). 
Historically, we have used a value of 0.80 for the loss-sharing ratio, 
which, we believe, preserves incentives for agencies to attempt to 
provide care efficiently for outlier cases. With a loss-sharing ratio 
of 0.80, Medicare pays 80 percent of the additional estimated costs 
that exceed the outlier threshold amount. In the CY 2020 HH PPS final 
rule with comment period, given the statutory requirement that total 
outlier payments not exceed 2.5 percent of the total payments estimated 
to be made under the HH PPS, we finalized a FDL ratio of 0.56 for 30-
day periods of care in CY 2020. For CY 2021, we proposed to maintain 
the same fixed-dollar loss ratio finalized for CY 2020.
    Comment: A commenter remarked on the proposed FDL ratio of 0.63 
that was in the CY 2021 HH PPS proposed rule and stated that the FDL 
ratio that was finalized for CY 2020 was 0.56. This commenter requested 
clarification as to this discrepancy and asked that CMS clearly state 
in the final rule the correct FDL ratio for CY 2021.
    Response: We apologize for the typographical error in the CY 2021 
HH PPS proposed rule regarding the FDL ratio for CY 2021. This 
commenter is correct, and as noted previously, the FDL ratio for CY 
2021 will be 0.56.
    Comment: A commenter supports the methodology used in the outlier 
provision and the per unit basis is appropriate to account for 
utilization and accompanying resources allocations by HHAs.
    Response: We thank the commenter for their support.
    Comment: A few commenters recommended to end the outlier provision 
entirely and reinstate the 5 percent withheld into regular 
reimbursements.
    Response: 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. 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.
    Final Decision: We are finalizing the fixed-dollar loss ratio of 
0.56 for CY 2021 to ensure that total outlier payments not exceed 2.5 
percent of the total payments estimated to be made under the HH PPS.

F. The Use of Telecommunications Technology Under the Medicare Home 
Health Benefit

    In the CY 2021 HH PPS proposed rule (85 FR 39427), we discussed the 
plan of care requirements at Sec.  409.43(a), revised on an interim 
basis, as outlined in the March 2020 COVID-19 IFC (85 FR 19230). For 
the purposes of Medicare payment during the COVID-19 PHE, this revision 
requires the plan of care to include any provision of remote patient 
monitoring or other services furnished via a telecommunications system 
and must describe how the use of such technology is tied to the 
patient-specific needs as identified in the comprehensive assessment 
and will help to achieve the goals outlined on the plan of care. The 
amended plan of care requirements at Sec.  409.43(a) also state that 
these services cannot substitute for a home visit ordered as part of 
the plan of care and cannot be considered a home visit for the purposes 
of patient eligibility or payment, in accordance with section 
1895(e)(1)(A) of the Act. We stated that we believed that this change 
will help to increase access to technologies, such as telemedicine and 
remote patient monitoring, during the COVID-19 PHE (85 FR 19250).
    Additionally, the Coronavirus Aid, Relief, and Economic Security 
Act (CARES Act) (Pub. L. 116-136) included section 3707 related to 
encouraging use of telecommunications systems for home health services 
furnished during the COVID-19 PHE. Specifically, section 3707 of the 
CARES Act requires, with respect to home health services furnished 
during the COVID-19 PHE, that the Secretary consider ways to encourage 
the use of telecommunications systems, including for remote patient 
monitoring as described in Sec.  409.46(e) and other communications or 
monitoring services, consistent with the plan of care for the 
individual, including by clarifying guidance and conducting outreach, 
as appropriate. In the CY 2021 HH PPS proposed rule (85 FR 39427), we 
stated that we believe that the policies finalized on an interim basis 
meet the requirements of section 3707 of the CARES Act.
    We also discussed hearing from stakeholders about the various 
applications of technologies that are currently in use by HHAs in the 
delivery of appropriate home health services outside of the COVID-19 
PHE (85 FR 39427). We stated 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

[[Page 70323]]

health services ordered as part of a plan of care, we understand that 
there are ways in which technology can be further utilized to improve 
patient care, better leverage advanced practice clinicians, and improve 
outcomes while potentially making the provision of home health care 
more efficient.
    For these reasons, we proposed to finalize the amendment to Sec.  
409.43(a) as set out in the March 2020 COVID-19 IFC (85 FR 19230) 
beyond the period of the COVID-19 PHE. We also proposed to allow HHAs 
to continue to report the costs of telehealth/telemedicine as allowable 
administrative costs on line 5 of the home health agency cost report. 
We proposed to modify the instructions regarding this line on the cost 
report to reflect a broader use of telecommunications technology. 
Specifically, we proposed to amend Sec.  409.46(e) to include not only 
remote patient monitoring, but other communication or monitoring 
services, consistent with the plan of care for the individual.
    We also reminded stakeholders that access to telecommunications 
technology must be accessible, including for patients with 
disabilities. Section 504 of the Rehabilitation Act, section 1557 of 
the Patient Protection and Affordable Care Act (ACA), and the Americans 
with Disabilities Act (ADA) protect qualified individuals with 
disabilities from discrimination on the basis of disability in the 
provision of benefits and services. Concerns related to potential 
discrimination issues under section 504, section 1557 of the ACA, and 
Title II of the ADA \6\ should be referred to the Office of Civil 
Rights for further review. Likewise, we reminded HHAs that the home 
health CoPs at Sec.  484.50(f)(1) require that information be provided 
to persons with disabilities in plain language and in a manner that is 
accessible and timely, including accessible websites and the provision 
of auxiliary aids and services at no cost to the individual in 
accordance with the ADA, section 1557 of the ACA, and section 504 of 
the Rehabilitation Act. This means that the HHA must meet these 
requirements to ensure access to and use of telecommunications as 
required by law. Appendix B of the State Operations Manual (regarding 
home health services) provides detailed examples of ``auxiliary aids 
and services''.\7\
---------------------------------------------------------------------------

    \6\ Discrimination on the Basis of Disability. https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
    \7\ State Operations Manual Appendix B--Guidance to Surveyors: 
Home Health Agencies, Tab G490. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf.
---------------------------------------------------------------------------

    We also reiterated the expectation that services provided by 
telecommunications technology are services that could also be provided 
through an in-person visit. We stated that if there is a service that 
cannot be provided through telecommunications technology (for example, 
wound care which requires in-person, hands-on care), the HHA must make 
an in-person visit to furnish such services (85 FR 39428). We also 
stated that an HHA couldn't discriminate against any individual who is 
unable (including because of other forms of discrimination), or 
unwilling to receive home health services provided via 
telecommunications technology. In those circumstances, the HHA must 
provide such services through in-person visits. Section 1861(m) of the 
Act defines ``home health services'' to mean the furnishing of items 
and services on a visiting basis in an individual's home (emphasis 
added).
    We received comments on the March 2020 COVID-19 IFC (85 FR 19230) 
regarding the interim amendment to Sec.  409.43(a), allowing the use of 
telecommunications technology to be included as part of the home health 
plan of care as long as the use of such technology does not substitute 
for in-person visits ordered on the plan of care during the COVID-19 
PHE, as well as comments on our proposal in the CY 2021 HH PPS proposed 
rule to finalize the amendment to Sec.  409.43(a) in the March 2020 
COVID-19 IFC (85 FR 19247). We also received comments on our proposal 
in the CY 2021 HH PPS proposed rule to amend the language at Sec.  
409.46(e), allowing a broader use of telecommunications technology to 
be reported as an allowable administrative cost on the home health 
agency cost report. A summary of the comments and our responses are as 
follows:
    Comment: Commenters overwhelmingly supported CMS' acknowledgment 
that telecommunications technology has a place in home health for 
public health emergencies and beyond. Many commenters supported the 
amendment to Sec.  409.43(a), allowing the use of telecommunications 
technology to be included as part of the home health plan of care 
during both the COVID-19 PHE, as well as beyond this time period, under 
the Medicare home health benefit. Commenters also supported amending 
the language at Sec.  409.46(e) allowing a broader use of 
telecommunications technology to be reported as allowable 
administrative costs on the home health cost report. Specifically, a 
commenter stated that in rural areas, ``telehealth services help to 
increase access to home health services that patients may otherwise 
forego due to challenges they face accessing care.'' This commenter 
stated that home health delivery through telecommunications 
technologies may help alleviate some of these access challenges and 
will provide greater flexibility for both patients and home health 
providers. Another commenter noted that these changes would ensure 
patient access to the latest technology and give home health agencies 
the confidence that they can continue to use telecommunications 
technology as part of patient care beyond the COVID-19 PHE. This 
commenter noted that allowing services via telecommunications 
technology is especially useful for certain vulnerable subsets of 
Medicare patients, such as cancer patients who may be 
immunocompromised, by helping to reduce unnecessary exposure to all 
illnesses, not just COVID-19. A few commenters noted that the decision 
to provide services via telecommunications technology should be based 
on the individual's needs as identified during the comprehensive 
assessment, making the proposal to incorporate these services into the 
plan of care essential. This may be especially important for 
individuals with dementia whose services may be more appropriately 
delivered solely through in-person care.
    Response: We thank commenters for their support.
    Comment: A few commenters noted that, while helpful for many home 
health patients, especially those with chronic conditions, CMS should 
put safeguards in place to ensure that in-person visits are not being 
replaced by telecommunications technology and that in-person visits 
remain at adequate levels. They reiterated the importance of ensuring 
patient choice for those patients that are appropriate candidates for 
remote patient monitoring or other services furnished via 
telecommunications technology. Additionally, a commenter noted that the 
policy changes might provide incentive for patient selection, causing 
agencies to favor patients who benefit from these services and avoid 
those who do not benefit. These commenters suggested that CMS monitor 
and analyze the effects of these policy changes on beneficiary care and 
program costs prior to extending them beyond the COVID-19 PHE. A 
commenter stated that monitoring might be difficult because there is no 
requirement for HHAs to report on

[[Page 70324]]

claims or patient assessments when an episode includes the provision of 
services via telecommunications technology. This commenter also stated 
that a new category of broadly defined services could also reduce the 
accuracy of home health agency cost reports, potentially resulting in 
erroneous reporting and distorting the financial information that CMS 
uses to set and analyze payment weights, and suggested that CMS 
indicate how, in the absence of patient-level reporting, the agency 
plans to assess the impact of ``other services provided via 
telecommunications'' and ensure access to and quality of care while 
maintaining program integrity.
    Response: We appreciate the commenters' concerns regarding how 
these changes will affect the delivery of home health care beyond the 
period of the COVID-19 PHE. We agree with the importance of ensuring 
that any services furnished via telecommunications technology and/or 
remote patient monitoring do not replace in-person visits as ordered on 
the plan of care as this is prohibited by statute. However, we believe 
that the use of telecommunications technology in furnishing services in 
the home has the potential to improve efficiencies, expand the reach of 
healthcare providers, allow more specialized care in the home, and 
allow HHAs to see more patients or to communicate with patients more 
often. We expect physicians and allowed practitioners to only order 
services to be furnished via telecommunications technology, including 
remote patient monitoring, when it is in the best interest of each 
individual patient and after it has been determined that the patient 
would benefit from services furnished in this manner, as in-person care 
in the patient's home is the hallmark of the home health benefit. We 
proposed that the use of the technology must be related to the skilled 
services being furnished in order to optimize the services furnished 
during the home visit and included on the plan of care, along with a 
description of how the use of such technology is tied to the patient-
specific needs as identified in the comprehensive assessment and how it 
will help to achieve the goals outlined on the plan of care. 
Implementing this as a condition for payment is a patient safeguard to 
ensure that HHAs are carefully evaluating not only whether a patient is 
an appropriate candidate for services furnished via telecommunications 
technology, but also that once implemented into the patient's care, it 
is benefitting the patient. We plan to monitor and analyze the cost 
report data and, as with all allowable administrative costs, we expect 
HHAs to be diligent and accurate in their reporting of these costs. We 
will also consider potential options regarding collecting data on the 
use of telecommunications technology on home health claims in order to 
expand monitoring efforts and evaluation.
    Comment: Several commenters expressed concern about the proposed 
plan of care requirement, stating that without some flexibility in this 
requirement, HHAs may be at risk for unreasonable claim denials. 
Commenters suggested that CMS should permit documentation throughout 
the medical record to be used to support the use of telecommunications 
technology, and limit the plan of care requirement to the physician's 
order that permits the HHA to use the telecommunications technology.
    Response: In accordance with the home health CoPs at Sec.  484.60 
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. This includes the types of services, supplies, and equipment 
required to meet these needs. Requiring that services furnished through 
telecommunications technology be incorporated into the plan of care, 
rather than simply requiring a physician's or allowed practitioner's 
order, acknowledges that each plan of care is unique to the individual. 
It is not our intent to simply promote the use of telecommunications 
technology without ensuring that furnishing the service in this way is 
beneficial to the individual patient.
    We believe it is essential to ensure that each patient is evaluated 
during the comprehensive assessment and care planning process for 
appropriateness of the use of services furnished via telecommunications 
technology. The patient care plan would then identify and distinguish 
goals and expected outcomes, outline nursing observations and 
interventions needed for documentation, and include instructions the 
patient or caregiver may require. These tailored objectives are 
exceptionally important when furnishing services in a manner that may 
be new or unfamiliar to patients and family members and help to provide 
consistency among caregivers; however, we do understand that this 
information may be documented more extensively throughout the medical 
record, along with more detail regarding how the patient is benefitting 
from the technology. We maintain that the provision of remote patient 
monitoring or other services furnished via a telecommunications system 
must be on the plan of care and such services must be tied to the 
patient-specific needs as identified in the comprehensive assessment; 
however, in response to comments from the public, we are not requiring 
as part of the plan of care, a description of how the use of such 
technology will help to achieve the goals outlined on the plan of care. 
Instead, we would expect information regarding how such services will 
help to achieve the goals outlined on the plan of care to be in the 
medical record documentation for the patient.
    Comment: Several commenters stated that because these services 
cannot substitute for a home visit ordered as part of the plan of care 
and cannot be considered a home visit for the purposes of patient 
eligibility or payment, the new flexibilities will be of little benefit 
to HHAs and Medicare beneficiaries. These commenters requested that CMS 
work with Congress to amend Social Security Act section 1895(e)(1)(A) 
to allow payment for services furnished via a telecommunications system 
when those services substitute for in-person home health services 
ordered as part of a plan of care. Other commenters requested that 
Medicare reimburse the HHA for telehealth services that are included in 
the plan of care on the physician fee schedule or at the current low 
utilization payment adjustment rates per discipline of service, or 
explore ways to reimburse telehealth furnished by home health agencies 
in a way that supplements in-person visits, recognizing the statutory 
impediment. Commenters suggested that CMS develop a model for claims 
reporting and payment for home health visits provided by 
telecommunications systems. Additionally, a few commenters stated that 
CMS should permit telecommunication technologies to include audio only 
(telephonic) technology beyond the period of the COVID-19 PHE.
    Response: By law, services furnished via a telecommunications 
system cannot be considered a home health visit for purposes of 
eligibility or payment; however, we disagree that this means these 
services will offer little benefit to HHAs and beneficiaries for the 
reasons discussed in previously in this section of this final rule. As 
stated previously, we believe utilizing telecommunications technology 
to furnish home health

[[Page 70325]]

services has the potential to improve efficiencies, expand the reach of 
healthcare providers, allow more specialized care in the home, and 
allow HHAs to see more patients or to communicate with patients more 
often. We will consider potential options for collecting data regarding 
the use of telecommunications technology on home health claims. We 
believe that using any available form of telecommunications technology 
or audio-only technology (i.e., telephone calls), for certain home 
health services is imperative during the period of the COVID-19 PHE, 
and did not propose to restrict its usage beyond this timeframe. 
Therefore, we are clarifying in the regulations that audio-only 
technology may continue to be utilized to furnish skilled home health 
services (though audio-only telephone calls are not considered a visit 
for purposes of eligibility or payment and cannot replace in-person 
visits as ordered on the plan of care) after the expiration of the PHE. 
Like telecommunications technology, if audio-only services are ordered 
by the physician or allowed practitioner to furnish a skilled service, 
this must be included on the plan of care. The home health agency and 
patient's physician/practitioner must determine whether such audio-only 
technology can meet the patient's needs. Unlike telecommunications 
technology, audio-only technology (that is, telephones) is reported as 
a ``general'' expense and would not be reported on line 5 of the home 
health cost report as an allowed administrative expense for 
telecommunications technology.
    Comment: A commenter recommended that CMS consider applying a PHE 
policy that was established for skilled nursing facilities to the Part 
A home health benefit, which would allow services provided on the 
premises, though not necessarily in the same room as the patient, to be 
considered in-person services.
    Response: It is unclear how the skilled nursing facility policy 
finalized during the COVID-19 PHE would translate to the home health 
benefit beyond the PHE. It does not seem cost effective to furnish a 
home visit at the patient's house conducted via a telecommunications 
system, when the use of telecommunications technology cannot be 
considered a visit for purposes of payment or eligibility, as outlined 
in statute at section 1895(e) of the Act. However, we do appreciate the 
commenter exploring ways in which these services could be utilized to 
limit potential exposure to COVID-19.
    Final Decision: We are finalizing the proposal to require that any 
provision of remote patient monitoring or other services furnished via 
a telecommunications system or audio-only technology must be included 
on the plan of care and cannot substitute for a home visit ordered as 
part of the plan of care, and cannot be considered a home visit for the 
purposes of eligibility or payment. We will still require that the use 
of such telecommunications technology or audio-only technology be tied 
to the patient-specific needs as identified in the comprehensive 
assessment, but we will not require as part of the plan of care, a 
description of how such technology will help to achieve the goals 
outlined on the plan of care. We expect to see documentation of how 
such services will be used to help achieve the goals outlined on the 
plan of care throughout the medical record when such technology is 
used. We are also finalizing the regulation text changes allowing a 
broader use of telecommunications technology to be considered allowable 
administrative costs on the home health cost report.

G. Care Planning for Medicare Home Health Services

    Section 3708 of the CARES Act, amended section 1861(aa)(5) of the 
Act, allowing the Secretary regulatory discretion regarding the 
requirements for nurse practitioners (NPs), clinical nurse specialists 
(CNSs), and physician assistants (PAs). That is, NPs, CNSs, and PAs (as 
those terms are defined in section 1861(aa) of the Act), would be able 
to practice at the top of their state licensure to certify eligibility 
for home health services, as well as establish and periodically review 
the home health plan of care. In accordance with section 1861(aa)(5) of 
the Act, NPs, CNSs, and PAs are required to practice in accordance with 
state law in the state in which the individual performs such services. 
HHAs or other practitioners should check with the relevant state 
licensing authority websites to ensure that practitioners are working 
within their scope of practice and prescriptive authority.
    As stated in the May 2020 COVID-19 IFC, we amended the regulations 
at parts 409, 424, and 484 to define an NP, a CNS, and a PA (as such 
qualifications are defined at Sec. Sec.  410.74 through 410.76) as an 
``allowed practitioner'' (85 FR 27572). This means that in addition to 
a physician, as defined at section 1861(r) of the Act, an ``allowed 
practitioner'' may certify, establish and periodically review the plan 
of care, as well as supervise the provision of items and services for 
beneficiaries under the Medicare home health benefit. Additionally, we 
amended the regulations to reflect that we would expect the allowed 
practitioner to also perform the face-to-face encounter for the patient 
for whom they are certifying eligibility; however, if a face-to-face 
encounter is performed by an allowed non-physician practitioner (NPP), 
as set forth in Sec.  424.22(a)(1)(v)(A), in an acute or post-acute 
facility, from which the patient was directly admitted to home health, 
the certifying practitioner may be different from the provider 
performing the face-to-face encounter. These regulation changes were 
not time limited to the period of the COVID-19 PHE.
    We inadvertently did not update Sec. Sec.  409.64(a)(2)(ii), 
410.170(b), and 484.110 in the regulations when implementing the 
requirements set forth in the CARES Act in the May 2020 COVID-19 IFC 
regarding the ``allowed practitioners'' who can certify and establish 
home health services. Therefore, in this final rule we are finalizing 
conforming regulation text changes at Sec. Sec.  409.64(a)(2)(ii), 
410.170(b), and 484.110 regarding allowed practitioner certification as 
a condition for payment for home health services. Although these 
changes were not proposed in the CY 2021 HH PPS proposed rule, we are 
adopting the changes here under a ``good cause'' waiver of proposed 
rulemaking, as described in section VI of this final rule. The specific 
changes we are making in the regulations are simply conforming 
regulations text changes to an already implemented policy required by 
section 3708 of the CARES Act, and do not reflect any additional 
substantive changes. Therefore, we find that undertaking further notice 
and comment procedures to incorporate these changes into this final 
rule is unnecessary and contrary to the public interest. We received a 
few comments on the regulation changes finalized in the May 2020 COVID-
19 IFC.
    Comment: Commenters gave their overall support for PAs and advanced 
practice registered nurses (APRNs) to order, certify, and recertify 
home health services. A commenter requested that CMS review and modify 
the language and definition of PAs and APRNs for home health services, 
specifically suggesting that CMS defer to state rules that govern the 
practice of NPs and CNSs with respect to collaboration with the 
physician and remove references to ``working in collaboration with the 
physician'' in the NP and CNS definitions.
    Response: We amended the regulations at parts 409, 424, and 484 to 
define an NP, a CNS, and a PA as such

[[Page 70326]]

qualifications are defined at Sec. Sec.  410.74 through 410.76. These 
sections specify that the services performed by these entities are only 
covered if the entity performs the services in accordance with state 
law and state scope of practice rules for PAs, NPs, and CNSs in the 
state in which such practitioner's professional services are furnished. 
Section 1861(aa)(5) of the Act allows the Secretary regulatory 
discretion regarding the requirements for NPs, CNSs, and PAs, and as 
such, we believe that we should align, for Medicare home health 
purposes, the definitions for such practitioners with the existing 
definitions in regulation at Sec. Sec.  410.74 through 410.76, for 
consistency across the Medicare program and to ensure that Medicare 
home health beneficiaries are afforded the same standard of care. 
Therefore, we are not revising the definitions at this time. As stated 
in the May 2020 COVID-19 IFC, HHAs or other practitioners should check 
with the relevant state licensing authority websites to ensure that 
practitioners are working within their scope of practice and 
prescriptive authority.

IV. Other Home Health Related Provisions

A. Home Health Quality Reporting Program (HH QRP)

1. Background and Statutory Authority
    The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. 
Section 1895(b)(3)(B)(v)(II) of the Act requires that, for 2007 and 
subsequent years, each HHA submit to the Secretary in a form and 
manner, and at a time, specified by the Secretary, such data that the 
Secretary determines are appropriate for the measurement of health care 
quality. To the extent that an HHA does not submit data in accordance 
with this clause, the Secretary shall reduce the home health market 
basket percentage increase applicable to the HHA for such year by 2 
percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, 
depending on the market basket percentage increase applicable for a 
particular year, the reduction of that increase by 2 percentage points 
for failure to comply with the requirements of the HH QRP and further 
reduction of the increase by the productivity adjustment (except in 
2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act 
may result in the home health market basket percentage increase being 
less than 0.0 percent for a year, and may result in payment rates under 
the Home Health PPS for a year being less than payment rates for the 
preceding year.
    For more information on the policies we have adopted for the HH 
QRP, we refer readers to the following:
     CY 2007 HH PPS final rule (71 FR 65888 through 65891).
     CY 2008 HH PPS final rule (72 FR 49861 through 49864).
     CY 2009 HH PPS update notice (73 FR 65356).
     CY 2010 HH PPS final rule (74 FR 58096 through 58098).
     CY 2011 HH PPS final rule (75 FR 70400 through 70407).
     CY 2012 HH PPS final rule (76 FR 68574).
     CY 2013 HH PPS final rule (77 FR 67092).
     CY 2014 HH PPS final rule (78 FR 72297).
     CY 2015 HH PPS final rule (79 FR 66073 through 66074).
     CY 2016 HH PPS final rule (80 FR 68690 through 68695).
     CY 2017 HH PPS final rule (81 FR 76752).
     CY 2018 HH PPS final rule (82 FR 51711 through 51712).
     CY 2019 HH PPS final rule with comment period (83 FR 
56547).
     CY 2020 HH PPS final rule with comment period (84 FR 
60554).
2. General Considerations Used for the Selection of Quality Measures 
for the HH QRP
    For a detailed discussion of the considerations we historically use 
for measure selection for the HH QRP quality, resource use, and others 
measures, we refer readers to the CY 2016 HH PPS final rule (80 FR 
68695 through 68696). In the CY 2019 HH PPS final rule with comment (83 
FR 56548 through 56550) we also finalized the factors we consider for 
removing previously adopted HH QRP measures.
3. Quality Measures Currently Adopted for the CY 2022 HH QRP
    The HH QRP currently includes 20 measures for the CY 2022 program 
year.\8\
---------------------------------------------------------------------------

    \8\ The HHCAHPS has five component questions that together are 
used to represent one NQF-endorsed measure.

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[[Page 70327]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.012

    There were no proposals or updates for the Home Health Quality 
Reporting Program (HH QRP). We received several comments on the HH QRP.
    Comment: Several commenters provided feedback on the Home Health 
Quality Reporting Program. A commenter recommended that CMS expedite 
development of new measures to address pain management after the recent 
removal of the Improvement in Pain Interfering with Activity quality 
measure from the HH QRP. Another commenter suggested the need to 
develop measures to address maintenance of functional status for 
patients who may not improve. A number of commenters expressed support 
for CMS's waivers related to quality reporting for quarters affected by 
the COVID-19 PHE. These commenters also suggested that CMS continue 
monitoring the effects of the public health epidemic on home health 
agencies' performance on all quality measures during the PHE. A 
commenter suggested adding new measures to the HH QRP to address 
advanced care planning and timely referral to hospice care. Another 
commenter noted support for the continued inclusion of the Influenza 
Immunization Received for the Current Flu Season quality measure and 
suggested the addition of the new composite adult immunizations measure 
being tested by the National Committee on Quality Assurance.
    Response: We appreciate these suggestions. These comments are 
outside the scope of the CY HH PPS 2021 proposed rule but we will 
consider them, as applicable, in future rulemaking.
    We recognize the importance of pain management as part of home 
health. We

[[Page 70328]]

would like to note that in the CY 2020 Home Health PPS final rule with 
comment period (84 FR 60592 through 60594), CMS finalized the Pain 
Interference (Pain Effect on Sleep, Pain Interference with Therapy 
Activities, and Pain Interference with Day-to-Day Activities) data 
elements as standardized patient assessment data elements This will 
allow HHAs to continue to collect information on patient pain that 
could support care planning, quality improvement, and potential quality 
measurement, including risk adjustment. HHAs must begin collecting data 
on the Pain Interference (Pain Effect on Sleep, Pain Interference With 
Therapy Activities, and Pain Interference With Day-to-Day Activities) 
SPADE on January 1st of the year that is at least one full calendar 
year after the end of the COVID-19 PHE (85 FR 27595 through 27596). In 
addition, the HHS Roadmap \9\ emphasizes non-pharmacological options 
for managing pain as critical in the efforts to reduce over-reliance on 
and misuse of opioids.
---------------------------------------------------------------------------

    \9\ CMS Roadmap, Strategy to Fight the Opioid Crisis. June 2020. 
https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Opioid-epidemic-roadmap.pdf.
---------------------------------------------------------------------------

    We appreciate the suggestions and we will continue to monitor the 
performance of home health agencies on quality measures and will 
consider the issues raised by commenters in future measure development 
efforts.

B. Change to the Conditions of Participation (CoPs) OASIS Requirements

    Section 484.45(c)(2) of the home health agency conditions of 
participation (CoPs) requires that new home health agencies must 
successfully transmit test data to the Quality Improvement & Evaluation 
System (QIES) or CMS OASIS contractor as part of the initial process 
for becoming a Medicare-participating home health agency. The previous 
data submission system limited HHAs to only two users who had 
permission to access the system, and required the use of a virtual 
private network (VPN) to access CMSNet. New HHAs do not yet have a CMS 
Certification Number (CCN). Therefore, they used a fake or test CCN in 
order to transmit test data to the Quality Improvement & Evaluation 
System Assessment Submission & Processing (QIES ASAP) System or CMS 
OASIS contractor.
    CMS recently enhanced the system that HHAs use to submit OASIS data 
to be more user friendly. The new CMS data submission system, internet 
Quality Improvement & Evaluation System (iQIES), is now internet-based. 
Therefore, HHAs are no longer limited to two users for submission of 
assessment data since VPN and CMSNet are no longer required. These 
factors make the data submission process simpler. In addition, the new 
iQIES data submission system requires users to include a valid CCN with 
their iQIES user role request that will allow them to submit their 
OASIS assessment data to CMS; the new data system no longer supports 
the use of test or fake CCNs, making it impossible for new HHAs that do 
not yet have a CCN to submit test data.
    The transition to the new data submission system, the simpler data 
submission process and the inability to use test or fake CCNs has 
rendered the requirement at Sec.  484.45(c)(2) obsolete. Therefore, we 
proposed to remove the requirement at Sec.  484.45(c)(2). HHAs must be 
able to submit assessments in order for the claims match process to 
occur and relay the data needed for payment under the PDGM system. This 
link to the payment process gives HHAs strong incentive to ensure that 
they can successfully submit their OASIS assessments in the absence of 
this regulatory requirement.
    We received two timely public comments on our proposed change to 
remove the OASIS requirement at Sec.  484.45(c)(2). Commenters included 
an industry association and an accreditation organization. Overall, the 
commenters were supportive of the removal of the provisions related to 
test transmission of OASIS data by a new HHA, because the provision is 
now obsolete due to changes in our data submission system. Summaries of 
the comments received and our responses are as follows.
    Comment: The commenters supported CMS's proposal to remove the 
provisions related to test transmission of OASIS data by a new HHA at 
Sec.  484.45(c)(2). Commenters agreed that as a result of the 
implementation of the internet Quality Improvement & Evaluation System 
(iQIES), they support removing the requirement at Sec.  484.45(c)(2) in 
accordance with improved online connectivity for reporting OASIS data.
    Response: We appreciate the unanimous support in deleting the OASIS 
requirement at Sec.  484.45(c)(2). Therefore, we are finalizing the 
removal of this requirement at Sec.  484.45(c)(2) for HHAs to 
successfully transmit test data to the QIES ASAP System or CMS OASIS 
contractor.

C. Finalization of the Provisions of the May 2020 Interim Final Rule 
With Comment Period Relating to the Home Health Value-Based Purchasing 
Model (HHVBP)

1. Background
    In the interim final rule with comment period that appeared in the 
May 8, 2020 Federal Register (May 2020 COVID-19 IFC) (85 FR 27553 
through 27554), we implemented a policy to align HHVBP Model data 
submission requirements with any exceptions or extensions granted for 
purposes of the HH QRP as well as a policy for granting exceptions to 
the New Measures data reporting requirements during the COVID-19 PHE. 
The comment period for that rule closed on July 7, 2020. In this 
section, we summarize these provisions of the May 2020 COVID-19 IFC, 
summarize and respond to the comments we received, and finalize these 
policies.
    As authorized by section 1115A of the Act and finalized in the CY 
2016 HH PPS final rule (80 FR 68624), 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. All Medicare certified HHAs providing 
services in Arizona, Florida, Iowa, Nebraska, North Carolina, 
Tennessee, Maryland, Massachusetts, and Washington are required to 
compete in the Model. The HHVBP Model uses the waiver authority under 
section 1115A(d)(1) of the Act to adjust Medicare payment rates under 
section 1895(b) of the Act based on the competing HHAs' performance on 
applicable measures. The maximum payment adjustment percentage 
increases incrementally over the course of the HHVBP Model in the 
following manner, upward or downward: (1) 3 percent in CY 2018; (2) 5 
percent in CY 2019; (3) 6 percent in CY 2020; (4) 7 percent in CY 2021; 
and (5) 8 percent in CY 2022. Payment adjustments are based on each 
HHA's Total Performance Score (TPS) in a given performance year (PY), 
which is comprised of performance on: (1) A set of measures already 
reported via the Outcome and Assessment Information Set (OASIS), 
completed Home Health Consumer Assessment of Healthcare Providers and 
Systems (HHCAHPS) surveys, and select claims data elements; and (2) 
three New

[[Page 70329]]

Measures for which points are achieved for reporting data.
2. Reporting Under the HHVBP Model for CY 2020 During the COVID-19 PHE
    In the May 2020 COVID-19 IFC, we established a policy to align the 
HHVBP Model data submission requirements with any exceptions or 
extensions granted for purposes of the HH QRP during the COVID-19 PHE. 
We also established a policy for granting exceptions to the New 
Measures data reporting requirements under the HHVBP Model during the 
PHE for COVID-19. Specifically, during the COVID-19 PHE, to the extent 
that the data that participating HHAs in the nine HHVBP Model states 
are required to report are the same data that those HHAs are also 
required to report for the HH QRP, HHAs are required to report those 
data for the HHVBP Model in the same time, form and manner that HHAs 
are required to report those data for the HH QRP. As such, if CMS 
grants an exception or extension that either excepts HHAs from 
reporting certain quality data altogether, or otherwise extends the 
deadlines by which HHAs must report those data, the same exceptions 
and/or extensions apply to the submission of those same data for the 
HHVBP Model. In addition, we adopted a policy to allow exceptions or 
extensions to New Measure reporting for HHAs participating in the HHVBP 
Model during the PHE for COVID-19.
    In the May 2020 COVID-19 IFC, we explained that the HHVBP Model 
utilizes some of the same quality measure data that are reported by 
HHAs for the HH QRP, including HHCAHPS survey data. The other HHVBP 
measures are calculated using OASIS data, which are still required to 
be reported during the PHE; however, we have given providers additional 
time to submit OASIS data (https://www.cms.gov/files/document/covid-home-health-agencies.pdf); claims-based data extracted from Medicare 
fee-for-service (FFS) claims; and New Measure data. To assist HHAs 
while they direct their resources toward caring for their patients and 
ensuring the health and safety of patients and staff, we adopted a 
policy for the HHVBP Model to align the HHVBP data submission 
requirements with any exceptions or extensions granted for purposes of 
the HH QRP during the COVID-19 PHE. For the same reason, we also 
established a policy for granting exceptions to New Measure reporting 
requirements for HHAs participating in the HHVBP Model during the 
COVID-19 PHE.
    We explained that under this policy, to the extent CMS has granted 
an exception to the HH QRP (for 2019 Q4 and 2020 Qs 1 and 2 as noted in 
the May 2020 COVID-19 IFC and below in this section), or may grant any 
future exceptions or extensions under this same program for other CY 
2020 reporting periods, HHAs in the nine HHVBP Model states do not need 
to separately report these measures for purposes of the HHVBP Model, 
and those same exceptions apply to the submission of those same data 
for the HHVBP Model. In accordance with this policy, we stated that if 
CMS grants an exception or extension under the HH QRP that either 
excepts HHAs from reporting certain quality data altogether, or 
otherwise extends the deadlines by which HHAs must report those data, 
the same exceptions and/or extensions apply to the submission of those 
same data for the HHVBP Model.
    In response to the COVID-19 PHE, on March 27, 2020, we issued 
public guidance (https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf) excepting HHAs from the requirement to report any HH QRP 
data for the following quarters:
     October 1, 2019-December 31, 2019 (Q4 2019).
     January 1, 2020-March 31, 2020 (Q1 2020).
     April 1, 2020-June 30, 2020 (Q2 2020).
    Under our policy to align HHVBP data submission requirements with 
any exceptions or extensions granted for purposes of the HH QRP during 
the COVID-19 PHE, HHAs in the nine HHVBP Model states are not required 
to separately report measure data for these quarters for purposes of 
the HHVBP Model. We noted that with regard to the exception from the 
requirement to report Q4 2019 HH QRP data, we do not anticipate any 
issues in calculating the TPSs based on CY 2019 data under the HHVBP 
Model because HHAs were able to submit these Q4 2019 data on a rolling 
basis prior to the COVID-19 PHE.
    In addition, to ensure that HHAs are able to focus on patient care 
in lieu of data submission during the COVID-19 PHE, we established a 
policy to allow us to grant exceptions to New Measure reporting for 
HHAs participating in the HHVBP Model during the COVID-19 PHE. We also 
specified that we were codifying these changes at Sec.  484.315(b). In 
accordance with this policy, we granted an exception to all HHAs 
participating in the HHVBP Model for the following New Measure 
reporting requirements:
     April 2020 New Measures submission period (data collection 
period October 1, 2019-March 31, 2020).
     July 2020 New Measures submission period (data collection 
period April 1, 2020-June 30, 2020).
    We noted in the May 2020 COVID-19 IFC that although the data 
collection period for the April 2020 New Measures submission period 
began in 2019, the data collected during this period are used for the 
calculation of the TPSs based on CY 2020, not CY 2019, data. We further 
noted that HHAs may optionally submit part or all of these data by the 
applicable submission deadlines. We stated that if we make the 
determination to grant an exception to New Measure data reporting for 
periods beyond the April and July 2020 submission periods, for example 
if the PHE for COVID-19 extends beyond the New Measure submission 
periods we had listed in the IFC, we would communicate this decision 
through routine communication channels to the HHAs participating in the 
HHVBP Model, including but not limited to issuing memos, emails and 
posting on the HHVBP Connect site (https://app.innovation.cms.gov/HHVBPConnect).
    We acknowledged that the exceptions to the HH QRP reporting 
requirements, as well as the modified submission deadlines for OASIS 
data and our exceptions for the New Measures reporting requirements, 
may impact the calculation of performance under the HHVBP Model for PY 
2020. We also noted that while we are able to extract the claims-based 
data from submitted Medicare FFS claims, we may need to assess the 
appropriateness of using the claims data submitted for the period of 
the PHE for COVID-19 for purposes of performance calculations under the 
HHVBP Model. We further explained that we are evaluating possible 
changes to our payment methodologies for CY 2022 in light of this more 
limited data, such as whether we would be able to calculate payment 
adjustments for participating HHAs for CY 2022, including those that 
continue to report data during CY 2020, if the overall data is not 
sufficient, as well as whether we may consider a different weighting 
methodology given that we may have sufficient data for some measures 
and not others. Further, we are also evaluating possible changes to our 
public reporting of CY 2020 performance year data. We stated that we 
intend to address any such changes to our payment methodologies for CY 
2022 or public reporting of data in future rulemaking.

[[Page 70330]]

    The following is a summary of public comments received and our 
responses:
    Comment: Several commenters supported the policy to align HHVBP 
Model data submission requirements with any exceptions or extensions 
granted for purposes of the HH QRP during the PHE for COVID-19.
    Response: We thank the commenters for their support.
    Comment: Several commenters inquired about CMS's utilization of 
data from the last performance year of the Model (CY 2020). Commenters 
suggested that we examine how the PHE has affected operations and 
relative performance and how that might impact 2020 performance 
calculations for the HHVBP Model. Several commenters requested that we 
not use any performance data from CY 2020 and terminate or suspend the 
model early. Another commenter requested that we extend reporting 
exceptions for Quarters 3 and 4 of CY 2020, stating that this would 
continue to provide regulatory relief for quality reporting programs 
across Medicare Fee-for-Service payment systems.
    Response: We thank the commenters for their comments. As we 
discussed in the May 2020 COVID-19 IFC, we acknowledge that the 
exceptions to the reporting requirements and modified submission 
deadlines may impact the calculation of performance under the HHVBP 
Model, and also that we may need to assess the appropriateness of using 
certain data submitted for the period of the PHE for purposes of 
performance calculations. CMS will continue to examine these issues as 
it reviews the data collected during CY 2020. We intend to address 
possible changes to our CY 2022 payment methodologies through 
rulemaking in the CY 2022 HH PPS proposed rule. With respect to the 
request to extend the reporting exceptions for additional quarters, we 
note that we did not grant any further exceptions under the HH QRP 
beyond Q2 of 2020 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Spotlight-and-Announcements). As previously described, our policy is to align HHVBP 
Model data submission requirements with any exceptions or extensions 
granted for purposes of the HH QRP during the PHE for COVID-19. For 
this same reason, we also did not grant further exceptions to HHVBP 
Model New Measure data submission periods beyond the July 2020 
submission period.
    Final Decision: After consideration of the comments received, we 
are finalizing without modification the policy to align HHVBP Model 
data submission requirements with any exceptions or extensions granted 
for purposes of the HH QRP during the COVID-19 PHE, as described in the 
May 2020 COVID-19 IFC. We are also finalizing without modification the 
policy for granting exceptions to the New Measures data reporting 
requirements under the HHVBP Model during the COVID-19 PHE, including 
the codification of these changes at Sec.  484.315(b), as described in 
the May 2020 COVID-19 IFC.

V. Home Infusion Therapy

A. Medicare Coverage of Home Infusion Therapy Services

1. Background and Overview
(a) Background
    Section 5012 of the 21st Century Cures Act (``the Cures Act'') 
(Pub. L. 114-255), which amended sections 1834(u), 1861(s)(2) and 
1861(iii) of the Act, established a new Medicare home infusion therapy 
services benefit. The Medicare home infusion therapy services benefit 
covers the professional services, including nursing services, furnished 
in accordance with the plan of care, patient training and education not 
otherwise covered under the durable medical equipment benefit, remote 
monitoring, and monitoring services for the provision of home infusion 
therapy and home infusion drugs furnished by a qualified home infusion 
therapy supplier. This benefit will ensure consistency in coverage for 
home infusion benefits for all Medicare beneficiaries.
    Section 50401 of the BBA of 2018 amended section 1834(u) of the Act 
by adding a new paragraph (7) that established a home infusion therapy 
services temporary transitional payment for eligible home infusion 
suppliers for certain items and services furnished in coordination with 
the furnishing of transitional home infusion drugs beginning January 1, 
2019. This temporary payment covers the cost of most of the same items 
and services, as defined in section 1861(iii)(2)(A) and (B) of the Act, 
related to the administration of home infusion drugs. The temporary 
transitional payment began on January 1, 2019 and will end the day 
before the full implementation of the home infusion therapy services 
benefit on January 1, 2021, as required by section 5012 of the 21st 
Century Cures Act.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56406), 
we finalized the implementation of temporary transitional payments for 
home infusion therapy services to begin on January 1, 2019. In 
addition, we implemented the establishment of regulatory authority for 
the oversight of national accrediting organizations (AOs) that accredit 
home infusion therapy suppliers, and their CMS-approved home infusion 
therapy accreditation programs.
(b) Overview of Infusion Therapy
    Infusion drugs can be administered in multiple health care 
settings, including inpatient hospitals, skilled nursing facilities 
(SNFs), hospital outpatient departments (HOPDs), physicians' offices, 
and in the home. Traditional fee-for-service (FFS) Medicare provides 
coverage for infusion drugs, equipment, supplies, and administration 
services. However, Medicare coverage requirements and payment vary for 
each of these settings. Infusion drugs, equipment, supplies, and 
administration are all covered by Medicare in the inpatient hospital, 
SNFs, HOPDs, and physicians' offices.
    Under the various Part A prospective payment systems, Medicare 
payment for the drugs, equipment, supplies, and services are bundled, 
meaning a single payment is made based on expected costs for 
clinically-defined episodes of care. For example, if a beneficiary is 
receiving an infusion drug during an inpatient hospital stay, the Part 
A payment for the drug, supplies, equipment, and drug administration is 
included in the diagnosis-related group (DRG) payment to the hospital 
under the Medicare inpatient prospective payment system. Beneficiaries 
are liable for the Medicare inpatient hospital deductible and no 
coinsurance for the first 60 days. Similarly, if a beneficiary is 
receiving an infusion drug while in a SNF under a Part A stay, the 
payment for the drug, supplies, equipment, and drug administration are 
included in the SNF prospective payment system payment. After 20 days 
of SNF care, there is a daily beneficiary cost-sharing amount through 
day 100 when the beneficiary becomes responsible for all costs for each 
day after day 100 of the benefit period.
    Under Medicare Part B, certain items and services are paid 
separately while other items and services may be packaged into a single 
payment together. For example, in an HOPD and in a physician's office, 
the drug is paid separately, generally at the average sales price (ASP) 
plus 6 percent (77 FR 68210). Medicare also makes a separate payment to 
the physician or hospital outpatient departments (HOPD) for 
administering the drug. The separate payment for infusion drug

[[Page 70331]]

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 service, provided the drugs are not 
usually self-administered by the patient. Drugs that are ``not usually 
self-administered,'' are defined in our manual according to how the 
Medicare population as a whole uses the drug, not how an individual 
patient or physician may choose to use a particular drug. For the 
purpose of this exclusion, the term ``usually'' means more than 50 
percent of the time for all Medicare beneficiaries who use the drug. 
The term ``by the patient'' means Medicare beneficiaries as a 
collective whole. Therefore, if a drug is self-administered by more 
than 50 percent of Medicare beneficiaries, the drug is generally 
excluded from Part B coverage. This determination is made on a drug-by-
drug basis, not on a beneficiary-by-beneficiary basis.\10\ The MACs 
update Self-Administered Drug (SAD) exclusion lists on a quarterly 
basis.\11\
---------------------------------------------------------------------------

    \10\ Medicare Benefit Policy Manual, Chapter 15, ``Covered 
Medical and Other Health Services'', section 50.2--Determining Self-
Administration of Drug or Biological. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
    \11\ Self-Administered Drug (SAD) Exclusion List Report. 
www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?bc=AQAAAAAAAAAAAA%3D%3D.
---------------------------------------------------------------------------

    Home infusion therapy involves the intravenous or subcutaneous 
administration of drugs or biologicals to an individual at home. 
Certain drugs can be infused in the home, but the nature of the home 
setting presents different challenges than the settings previously 
described. Generally, the components needed to perform home infusion 
include the drug (for example, antivirals, immune globulin), equipment 
(for example, a pump), and supplies (for example, tubing and 
catheters). Likewise, nursing services are usually necessary to train 
and educate the patient and caregivers on the safe administration of 
infusion drugs in the home. Visiting nurses often play a large role in 
home infusion. These nurses typically train the patient or caregiver to 
self-administer the drug, educate on side effects and goals of therapy, 
and visit periodically to assess the infusion site and provide dressing 
changes. Depending on patient acuity or the complexity of the drug 
administration, certain infusions may require more training and 
education, especially those that require special handling or pre-or 
post-infusion protocols. The home infusion process typically requires 
coordination among multiple entities, including patients, physicians, 
hospital discharge planners, health plans, home infusion pharmacies, 
and, if applicable, home health agencies.
    With regard to payment under traditional Medicare, most home 
infusion drugs are generally covered under Part B or Part D. Certain 
infusion pumps, supplies (including home infusion drugs and the 
services required to furnish the drug, (that is, preparation and 
dispensing), and nursing are covered in some circumstances through the 
Part B durable medical equipment (DME) benefit, the Medicare home 
health benefit, or some combination of these benefits. In accordance 
with section 50401 of the BBA of 2018, beginning on January 1, 2019, 
for CYs 2019 and 2020, Medicare implemented temporary transitional 
payments for home infusion therapy services furnished in coordination 
with the furnishing of transitional home infusion drugs. This payment, 
for home infusion therapy services, is only made if a beneficiary is 
furnished certain drugs and biologicals administered through an item of 
covered DME, and payable only to suppliers enrolled in Medicare as 
pharmacies that provide external infusion pumps and external infusion 
pump supplies (including the drug). With regard to the coverage of the 
home infusion drugs, Medicare Part B covers a limited number of home 
infusion drugs through the DME benefit if: (1) the drug is necessary 
for the effective use of an external infusion pump classified as DME 
and determined to be reasonable and necessary for administration of the 
drug; and (2) the drug being used with the pump is itself reasonable 
and necessary for the treatment of an illness or injury.
    Only certain types of infusion pumps are covered under the DME 
benefit. In order for the infusion pump to be covered under the DME 
benefit, it must be appropriate for use in the home (Sec.  414.202). 
The Medicare National Coverage Determinations Manual, chapter 1, part 
4, section 280.14 describes the types of infusion pumps that are 
covered under the DME benefit.\12\ For DME external infusion pumps, 
Medicare Part B covers the infusion drugs and other supplies and 
services necessary for the effective use of the pump. Through the Local 
Coverage Determination (LCD) for External Infusion Pumps (L33794), the 
DME Medicare administrative contractors (MACs) specify the details of 
which infusion drugs are covered with these pumps. Examples of covered 
Part B DME infusion drugs include, among others, certain IV drugs for 
heart failure and pulmonary arterial hypertension, immune globulin for 
primary immune deficiency (PID), insulin, antifungals, antivirals, and 
chemotherapy, in limited circumstances.
---------------------------------------------------------------------------

    \12\ National Coverage Determinations Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
---------------------------------------------------------------------------

(c) Home Infusion Therapy Legislation
(1). 21st Century Cures Act
    Effective January 1, 2021, section 5012 of the 21st Century Cures 
Act (Pub. L. 114-255) (Cures Act) created a separate Medicare Part B 
benefit category under section 1861(s)(2)(GG) of the Act for coverage 
of home infusion therapy services needed for the safe and effective 
administration of certain drugs and biologicals administered 
intravenously, or subcutaneously for an administration period of 15 
minutes or more, in the home of an individual, through a pump that is 
an item of DME. The infusion pump and supplies (including home infusion 
drugs) will continue to be covered under the Part B DME benefit. 
Section 1861(iii)(2) of the Act defines home infusion therapy to 
include the following items and services: The professional services, 
including nursing services, furnished in accordance with the plan, 
training and education (not otherwise paid for as DME), remote 
monitoring, and other monitoring services for the provision of home 
infusion therapy and home infusion drugs furnished by a qualified home 
infusion therapy supplier, which are furnished in the individual's 
home. Section 1861(iii)(3)(B) of the Act defines the patient's home to 
mean a place of residence used as the home of an individual as defined 
for purposes of section 1861(n) of the Act. As outlined in section 
1861(iii)(1) of the Act, to be eligible to receive home infusion 
therapy services under the home infusion therapy services 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

[[Page 70332]]

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 services 
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 that qualified home 
infusion therapy suppliers must furnish infusion therapy to individuals 
with acute or chronic conditions requiring administration of home 
infusion drugs; ensure the safe and effective provision and 
administration of home infusion therapy on a 7-day-a-week, 24-hour-a-
day basis; be accredited by an organization designated by the 
Secretary; and meet other such requirements as the Secretary deems 
appropriate, taking into account the standards of care for home 
infusion therapy established by Medicare Advantage (MA) plans under 
Part C and in the private sector. The supplier may subcontract with a 
pharmacy, physician, other qualified supplier or provider of medical 
services, in order to meet these requirements.
    Section 1834(u)(1) of the Act requires the Secretary to implement a 
payment system under which, beginning January 1, 2021, a single payment 
is made to a qualified home infusion therapy supplier for the items and 
services (professional services, including nursing services; training 
and education; remote monitoring, and other monitoring services). The 
single payment must take into account, as appropriate, types of 
infusion therapy, including variations in utilization of services by 
therapy type. In addition, the single payment amount is required to be 
adjusted to reflect geographic wage index and other costs that may vary 
by region, patient acuity, and complexity of drug administration. The 
single payment may be adjusted to reflect outlier situations, and other 
factors as deemed appropriate by the Secretary, which are required to 
be done in a budget-neutral manner. Section 1834(u)(2) of the Act 
specifies certain items that ``the Secretary may consider'' in 
developing the home infusion therapy payment system: ``the costs of 
furnishing infusion therapy in the home, consult[ation] with home 
infusion therapy suppliers, . . . payment amounts for similar items and 
services under this part and Part A, and . . . payment amounts 
established by Medicare Advantage plans under Part C and in the private 
insurance market for home infusion therapy (including average per 
treatment day payment amounts by type of home infusion therapy)''. 
Section 1834(u)(3) of the Act specifies that annual updates to the 
single payment are required to be made, beginning January 1, 2022, by 
increasing the single payment amount by the percent increase in the 
Consumer Price Index for all urban consumers (CPI-U) for the 12-month 
period ending with June of the preceding year, reduced by the 10-year 
moving average of changes in annual economy-wide private nonfarm 
business multifactor productivity (MFP). Under section 
1834(u)(1)(A)(iii) of the Act, the single payment amount for each 
infusion drug administration calendar day, including the required 
adjustments and the annual update, cannot exceed the amount determined 
under the fee schedule under section 1848 of the Act for infusion 
therapy services if furnished in a physician's office. This statutory 
provision limits the single payment amount so that it cannot reflect 
more than 5 hours of infusion for a particular therapy per calendar 
day. Section 1834(u)(4) of the Act also allows the Secretary 
discretion, as appropriate, to consider prior authorization 
requirements for home infusion therapy services. Finally, section 
5012(c)(3) of the 21st Century Cures Act amended section 1861(m) of the 
Act to exclude home infusion therapy from the HH PPS beginning on 
January 1, 2021.
(2). Bipartisan Budget Act of 2018
    Section 50401 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123) amended section 1834(u) of the Act by adding a new paragraph (7) 
that established a home infusion therapy services temporary 
transitional payment for eligible home infusion suppliers for certain 
items and services furnished in coordination with the furnishing of 
transitional home infusion drugs, beginning January 1, 2019. This 
payment covers the same items and services as defined in section 
1861(iii)(2)(A) and (B) of the Act, furnished in coordination with the 
furnishing of transitional home infusion drugs. Section 
1834(u)(7)(A)(iii) of the Act defines the term ``transitional home 
infusion drug'' using the same definition as ``home infusion drug'' 
under section 1861(iii)(3)(C) of the Act, which is a parenteral drug or 
biological administered intravenously, or subcutaneously for an 
administration period of 15 minutes or more, in the home of an 
individual through a pump that is an item of DME as defined under 
section 1861(n) of the Act. The definition of ``home infusion drug'' 
excludes ``a self-administered drug or biological on a self-
administered drug exclusion list'' but the definition of ``transitional 
home infusion drug'' notes that this exclusion shall not apply if a 
drug described in such clause is identified in clauses (i), (ii), (iii) 
or (iv) of 1834(u)(7)(C) of the Act. Section 1834(u)(7)(C) of the Act 
sets out the Healthcare Common Procedure Coding System (HCPCS) codes 
for the drugs and biologicals covered under the DME LCD for External 
Infusion Pumps (L33794),\13\ as the drugs covered during the temporary 
transitional period. In addition, section 1834(u)(7)(C) of the Act 
states that the Secretary shall assign to an appropriate payment 
category drugs which are covered under the DME LCD for External 
Infusion Pumps (L33794) \14\ and billed under HCPCS codes J7799 (Not 
otherwise classified drugs, other than inhalation drugs, administered 
through DME) and J7999 (Compounded drug, not otherwise classified), or 
billed under any code that is implemented after the date of the 
enactment of this paragraph and included in such local coverage 
determination or included in subregulatory guidance as a home infusion 
drug.
---------------------------------------------------------------------------

    \13\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
    \14\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
---------------------------------------------------------------------------

    Section 1834(u)(7)(E)(i) of the Act states that payment to an 
eligible home infusion supplier or qualified home infusion therapy 
supplier for an infusion drug administration calendar day in the 
individual's home refers to payment only for the date on which 
professional services, as described in section 1861(iii)(2)(A) of the 
Act, were furnished to administer such drugs to such individual. This 
includes all such drugs administered to such individual on such day. 
Section 1842(u)(7)(F) of the Act defines ``eligible home infusion 
supplier'' as a supplier who is enrolled in Medicare as a pharmacy that 
provides external infusion pumps and external infusion pump supplies, 
and that maintains all pharmacy licensure requirements in the State in 
which the

[[Page 70333]]

applicable infusion drugs are administered.
    As set out at section 1834(u)(7)(C) of the Act, identified HCPCS 
codes for transitional home infusion drugs are assigned to three 
payment categories, as identified by their corresponding HCPCS codes, 
for which a single amount will be paid for home infusion therapy 
services furnished on each infusion drug administration calendar day. 
Payment category 1 includes certain intravenous infusion drugs for 
therapy, prophylaxis, or diagnosis, including antifungals and 
antivirals; inotropic and pulmonary hypertension drugs; pain management 
drugs; and chelation drugs. Payment category 2 includes subcutaneous 
infusions for therapy or prophylaxis, including certain subcutaneous 
immunotherapy infusions. Payment category 3 includes intravenous 
chemotherapy infusions, including certain chemotherapy drugs and 
biologicals. The payment category for subsequent transitional home 
infusion drug additions to the DME LCD for External Infusion Pumps 
(L33794) and compounded infusion drugs not otherwise classified, as 
identified by HCPCS codes J7799 and J7999, will be determined by the 
DME MACs.
    In accordance with section 1834(u)(7)(D) of the Act, each payment 
category is paid at amounts in accordance with the Physician Fee 
Schedule (PFS) for each infusion drug administration calendar day in 
the individual's home for drugs assigned to such category, without 
geographic adjustment. Section 1834(u)(7)(E)(ii) of the Act requires 
that in the case that two (or more) home infusion drugs or biologicals 
from two different payment categories are administered to an individual 
concurrently on a single infusion drug administration calendar day, one 
payment for the highest payment category will be made.
(d) Summary of CY 2019 and CY 2020 Home Infusion Therapy Provisions
    In the CY 2019 HH PPS final rule with comment period (83 FR 56579) 
we finalized the implementation of the home infusion therapy services 
temporary transitional payments under paragraph (7) of section 1834(u) 
of the Act, for CYs 2019 and 2020. These services are furnished in the 
individual's home to an individual who is under the care of an 
applicable provider (defined in section 1861(iii)(3)(A) of the Act as a 
physician, nurse practitioner, or physician's assistant) and where 
there is a plan of care established and periodically reviewed by a 
physician (defined at section 1861(r)(1) of the Act), prescribing the 
type, amount, and duration of infusion therapy services. Only eligible 
home infusion suppliers can bill for the temporary transitional 
payments. Therefore, in accordance with section 1834(u)(7)(F) of the 
Act, we clarified that this meant that in addition to other DME 
suppliers, existing DME suppliers that were enrolled in Medicare as 
pharmacies that provided external infusion pumps and external infusion 
pump supplies, who complied with Medicare's DME Supplier and Quality 
Standards, and maintained all pharmacy licensure requirements in the 
State in which the applicable infusion drugs were administered, could 
be considered eligible home infusion suppliers for purpose of the 
temporary home infusion therapy benefit.
    Section 1834(u)(7)(C) of the Act assigns transitional home infusion 
drugs, identified by the HCPCS codes for the drugs and biologicals 
covered under the DME LCD for External Infusion Pumps (L33794),\15\ 
into three payment categories, for which we established a single 
payment amount per category in accordance with section 1834(u)(7)(D) of 
the Act. This section states that each single payment amount per 
category will be paid at amounts equal to the amounts determined under 
the PFS established under section 1848 of the Act for services 
furnished during the year for codes and units of such codes, without 
geographic adjustment. Therefore, we created a new HCPCS G-code for 
each of the three payment categories and finalized the billing 
procedure for the temporary transitional payment for eligible home 
infusion suppliers. We stated that the eligible home infusion supplier 
would submit, in line-item detail on the claim, a G-code for each 
infusion drug administration calendar day. We stated that the claim 
should include the length of time, in 15-minute increments, for which 
professional services were furnished. The G-codes could be billed 
separately from, or on the same claim as, the DME, supplies, or 
infusion drug, and would be processed through the DME MACs. On August 
10, 2018, we issued Change Request: R4112CP: Temporary Transitional 
Payment for Home Infusion Therapy Services for CYs 2019 and 2020 \16\ 
outlining the requirements for the claims processing changes needed to 
implement this payment.
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    \15\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794&ver=83&Date=05%2f15%2f2019&DocID=L33794&bc=iAAAABAAAAAA&.
    \16\ Temporary Transitional Payment for Home Infusion Therapy 
Services for CYs 2019 and 2020. August 10, 2018. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4112CP.pdf
---------------------------------------------------------------------------

    And lastly, we finalized the definition of ``infusion drug 
administration calendar day'' in regulation as the day on which home 
infusion therapy services are furnished by skilled professional(s) in 
the individual's home on the day of infusion drug administration. The 
skilled services provided on such day must be so inherently complex 
that they can only be safely and effectively performed by, or under the 
supervision of, professional or technical personnel (42 CFR 486.505). 
Section 1834(u)(7)(E)(i) of the Act clarifies that this definition is 
with respect to the furnishing of ``transitional home infusion drugs'' 
and ``home infusion drugs'' to an individual by an ``eligible home 
infusion supplier'' and a ``qualified home infusion therapy supplier.'' 
The definition of ``infusion drug administration calendar day'' applies 
to both the temporary transitional payment in CYs 2019 and 2020 and the 
permanent home infusion therapy services benefit to be implemented 
beginning in CY 2021.
2. Summary of Home Infusion Therapy Services for CY 2021 and Subsequent 
Years
    Upon completion of the temporary transitional payments for home 
infusion therapy services at the end of CY 2020, we will be 
implementing the permanent payment system for home infusion therapy 
services under section 5012 of the 21st Century Cures Act (Pub. L. 114-
255) beginning January 1, 2021. In the CY 2020 HH PPS final rule with 
comment period, we finalized provisions regarding payment for home 
infusion therapy services for CY 2021 and subsequent years in order to 
allow adequate time for eligible home infusion therapy suppliers to 
make any necessary software and business process changes for 
implementation on January 1, 2021.
(a) Scope of Benefit and Conditions for Payment
    Section 1861(iii) of the Act establishes certain provisions related 
to home infusion therapy with respect to the requirements that must be 
met for Medicare payment to be made to qualified home infusion therapy 
suppliers. These provisions serve as the basis for determining the 
scope of the home infusion drugs eligible for coverage of home infusion 
therapy services, outlining beneficiary qualifications and plan of care 
requirements, and establishing who can bill for payment under the 
benefit.

[[Page 70334]]

(1). Home Infusion Drugs
    In the CYs 2019 and 2020 HH PPS proposed rules (83 FR 32466 and 84 
FR 34690) we discussed the relationship between the home infusion 
therapy services benefit and the DME benefit. We stated that, as there 
is no separate Medicare Part B DME payment for the professional 
services associated with the administration of certain home infusion 
drugs covered as supplies necessary for the effective use of external 
infusion pumps, we consider the home infusion therapy services benefit 
to be a separate payment in addition to the existing payment for the 
DME equipment, accessories, and supplies (including the home infusion 
drug) made under the DME benefit. We stated that, consistent with the 
definition of ``home infusion therapy,'' the home infusion therapy 
services payment explicitly and separately pays for the professional 
services related to the administration of the drugs identified on the 
DME LCD for External Infusion Pumps (L33794),\17\ when such services 
are furnished in the individual's home. For purposes of the temporary 
transitional payments for home infusion therapy services in CYs 2019 
and 2020, the term ``transitional home infusion drug'' includes the 
HCPCS codes for the drugs and biologicals covered under the DME LCD for 
External Infusion Pumps (L33794).\18\ We also noted that although 
section 1834(u)(7)(A)(iii) of the Act defines the term ``transitional 
home infusion drug,'' section 1834(u)(7)(A)(iii) of the Act does not 
specify the HCPCS codes for ``home infusion drugs'' for which home 
infusion therapy services would be covered beginning in CY 2021.
---------------------------------------------------------------------------

    \17\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
    \18\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
---------------------------------------------------------------------------

    Section 1861(iii)(3)(C) of the Act defines ``home infusion drug'' 
as a parenteral drug or biological administered intravenously, or 
subcutaneously for an administration period of 15 minutes or more, in 
the home of an individual through a pump that is an item of durable 
medical equipment (as defined in section 1861(n) of the Act). Such term 
does not include insulin pump systems or self-administered drugs or 
biologicals on a self-administered drug exclusion list. This definition 
not only specifies that the drug or biological must be administered 
through a pump that is an item of DME, but references the statutory 
definition of DME at 1861(n) of the Act. This means that ``home 
infusion drugs'' are drugs and biologicals administered through a pump 
that is covered under the Medicare Part B DME benefit. Therefore, in 
the CY 2020 HH PPS final rule with comment period (84 FR 60618), we 
stated that this means that ``home infusion drugs'' are defined as 
parenteral drugs and biologicals administered intravenously, or 
subcutaneously for an administration period of 15 minutes or more, in 
the home of an individual through a pump that is an item of DME covered 
under the Medicare Part B DME benefit, pursuant to the statutory 
definition set out at section 1861(iii)(3)(C) of the Act, and 
incorporated by cross reference at section 1834(u)(7)(A)(iii) of the 
Act.
(2). Patient Eligibility and Plan of Care Requirements
    Subparagraphs (A) and (B) of section 1861(iii)(1) of the Act set 
forth beneficiary eligibility and plan of care requirements for ``home 
infusion therapy.'' In accordance with section 1861(iii)(1)(A) of the 
Act, the beneficiary must be under the care of an applicable provider, 
defined in section 1861(iii)(3)(A) of the Act as a physician, nurse 
practitioner, or physician assistant. In accordance with section 
1861(iii)(1)(B) of the Act, the beneficiary must also be under a plan 
of care, established by a physician (defined at section 1861(r)(1) of 
the Act), prescribing the type, amount, and duration of infusion 
therapy services that are to be furnished, and periodically reviewed, 
in coordination with the furnishing of home infusion drugs under Part 
B. Based on these statutory requirements, and in accordance with the 
standards at Sec.  486.520, we finalized the home infusion therapy 
services conditions for payment at 42 CFR part 414, subpart P via the 
CY 2020 HH PPS final rule with comment period (84 FR 60618).
(3). Qualified Home Infusion Therapy Suppliers and Professional 
Services
    Section 1861(iii)(3)(D)(i) of the Act defines a ``qualified home 
infusion therapy supplier'' as a pharmacy, physician, or other provider 
of services or supplier licensed by the State in which the pharmacy, 
physician, or provider of services or supplier furnishes items or 
services. The qualified home infusion therapy supplier must: Furnish 
infusion therapy to individuals with acute or chronic conditions 
requiring administration of home infusion drugs; ensure the safe and 
effective provision and administration of home infusion therapy on a 7-
day-a-week, 24-hour a-day basis; be accredited by an organization 
designated by the Secretary; and meet such other requirements as the 
Secretary determines appropriate.
    Section 1861(iii)(2) of the Act defines home infusion therapy to 
include the following items and services: The professional services, 
including nursing services, furnished in accordance with the plan, 
training and education (not otherwise paid for as DME), remote 
monitoring, and other monitoring services for the provision of home 
infusion therapy and home infusion drugs furnished by a qualified home 
infusion therapy supplier, which are furnished in the individual's 
home. Section 1861(iii)(2) of the Act does not define home infusion 
therapy services to include the pump, home infusion drug, or related 
services. Therefore, in the CY 2020 HH PPS final rule with comment 
period, we noted that the infusion pump, drug, and other supplies, and 
the services required to furnish these items (that is, the compounding 
and dispensing of the drug) remain covered under the DME benefit.
    We stated in the CY 2020 HH PPS proposed rule that we did not 
specifically enumerate a list of ``professional services'' for which 
the qualified home infusion therapy supplier is responsible in order to 
avoid limiting services or the involvement of providers of services or 
suppliers that may be necessary in the care of an individual patient 
(84 FR 34692). However, we noted that, under section 1862(a)(1)(A) of 
the Act, no payment can be made for Medicare services under Part B that 
are not reasonable and necessary for the diagnosis or treatment of 
illness or injury or to improve the functioning of a malformed body 
member, unless explicitly authorized by statutes. We stated that this 
means that the qualified home infusion therapy supplier is responsible 
for the reasonable and necessary services related to the administration 
of the home infusion drug in the individual's home. These services may 
require some degree of care coordination or monitoring outside of an 
infusion drug administration calendar day. However, payment for these 
services is built into the bundled payment for an infusion drug 
administration calendar day.
    Payment to a qualified home infusion therapy supplier is for an 
infusion drug administration calendar day in the individual's home, 
which, in accordance with section 1834(u)(7)(E) of the Act, refers to 
payment only for the date on which professional services were furnished 
to administer such drugs

[[Page 70335]]

to such individual. Ultimately, the qualified home infusion therapy 
supplier is the entity responsible for furnishing the necessary 
services to administer the drug in the home and, as we noted in the CY 
2019 HH PPS final rule with comment period (83 FR 56581), 
``administration'' refers to the process by which the drug enters the 
patient's body. Therefore, it is necessary for the qualified home 
infusion therapy supplier to be in the patient's home, on occasions 
when the drug is being administered in order to provide an accurate 
assessment to the physician responsible for ordering the home infusion 
drug and services. The services provided would include patient 
evaluation and assessment; training and education of patients and their 
caretakers, assessment of vascular access sites and obtaining any 
necessary bloodwork; and evaluation of medication administration. 
However, visits made solely for the purposes of venipuncture on days 
where there is no administration of the infusion drug would not be 
separately paid because the single payment includes all services for 
administration of the drug. Payment for an infusion drug administration 
calendar day is a bundled payment, which reflects not only the visit 
itself, but any necessary follow-up work (which could include visits 
for venipuncture), or care coordination provided by the qualified home 
infusion therapy supplier. Any care coordination, or visits made for 
venipuncture, provided by the qualified home infusion therapy supplier 
that occurs outside of an infusion drug administration calendar day 
would be included in the payment for the visit (83 FR 56581).
    Additionally, section 1861(iii)(1)(B) of the Act requires that the 
patient be under a plan of care established and periodically reviewed 
by a physician, in coordination with the furnishing of home infusion 
drugs. The physician is responsible for ordering the reasonable and 
necessary services for the safe and effective administration of the 
home infusion drug, as indicated in the patient plan of care. In 
accordance with this section, the physician is responsible for 
coordinating the patient's care in consultation with the DME supplier 
furnishing the infusion pump and the home infusion drug. We recognize 
that collaboration between the ordering physician and the DME supplier 
furnishing the home infusion drug is imperative in providing safe and 
effective home infusion. Payment for physician services, including any 
home infusion care coordination services, are separately paid to the 
physician under the PFS and are not covered under the home infusion 
therapy services benefit. However, payment under the home infusion 
therapy services benefit to eligible home infusion therapy suppliers is 
for the professional services that inform collaboration between 
physicians and home infusion therapy suppliers. Care coordination 
between the physician and DME supplier, although likely to include 
review of the services indicated in the home infusion therapy supplier 
plan of care, is paid separately from the payment under the home 
infusion therapy services benefit.
    As discussed in the CY 2020 HH PPS proposed rule, the DME quality 
standards require the supplier to review the patient's record and 
consult with the prescribing physician as needed to confirm the order 
and to recommend any necessary changes, refinements, or additional 
evaluations to the prescribed equipment, item(s), and/or service(s) (84 
FR 34692). Follow-up services to the beneficiary and/or caregiver(s), 
must be consistent with the type(s) of equipment, item(s) and 
service(s) provided, and include recommendations from the prescribing 
physician or healthcare team member(s).\19\ Additionally, DME suppliers 
are required to communicate directly with patients regarding their 
medications.
---------------------------------------------------------------------------

    \19\ Durable Medical Equipment, Prosthetics, Orthotics, and 
Supplies (DMEPOS) Quality Standards. https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Downloads/Final-DMEPOS-Quality-Standards-Eff-01-09-2018.pdf.
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    In summary, the qualified home infusion therapy supplier is 
responsible for the reasonable and necessary services related to the 
administration of the home infusion drug in the individual's home. 
These services may require some degree of care coordination or 
monitoring outside of an infusion drug administration calendar day; 
payment for these services is built into the bundled payment for an 
infusion drug administration calendar day. Furthermore, as we noted in 
the CY 2019 HH PPS proposed rule, we consider the home infusion benefit 
principally to be a separate payment in addition to the existing 
payment made under the DME benefit, thus explicitly and separately 
paying for the home infusion therapy services (83 FR 32466). Therefore, 
the professional services covered under the DME benefit are not covered 
under the home infusion benefit. While the two benefits exist in 
tandem, the services are unique to each benefit and billed and paid for 
under separate payment systems. While we did not make any proposals 
regarding policies finalized in the CY 2020 HH PPS final rule with 
comment period as they relate to the implementation of the permanent 
home infusion therapy services in CY 2021, we did receive comments 
making suggestions to change certain aspects of the finalized policies. 
As we did not make any proposals in the CY 2021 proposed rule, we view 
these comments outside of the scope of this rule. However, we will keep 
these comments in mind for future rulemaking.
(4). Home Infusion Therapy and Interaction With the Home Health Benefit
    Because a qualified home infusion therapy supplier is not required 
to become accredited as a Part B DME supplier or to furnish the home 
infusion drug, and because payment is determined by the provision of 
services furnished in the patient's home, we acknowledged in the CY 
2019 HH PPS proposed rule the potential for overlap between the new 
home infusion therapy services benefit and the home health benefit (83 
FR 32469). We stated that a beneficiary is not required to be 
considered homebound in order to be eligible for the home infusion 
therapy services benefit; however, there may be instances where a 
beneficiary under a home health plan of care also requires home 
infusion therapy services. Additionally, because section 5012 of the 
21st Century Cures Act amends section 1861(m) of the Act to exclude 
home infusion therapy from home health services effective on January 1, 
2021; we stated that a beneficiary may utilize both benefits 
concurrently.
    Furthermore, because both the home health agency and the qualified 
home infusion therapy supplier furnish services in the individual's 
home, and may potentially be the same entity, the best process for 
payment for furnishing home infusion therapy services to beneficiaries 
who qualify for both benefits is as outlined in the CY 2019 HH PPS 
proposed rule (83 FR 32469). If a patient receiving home infusion 
therapy is also under a home health plan of care, and receives a visit 
that is unrelated to home infusion therapy, then payment for the home 
health visit would be covered by the HH PPS and billed on the home 
health claim. When the home health agency furnishing home health 
services is also the qualified home infusion therapy supplier 
furnishing home infusion therapy services, and a home visit is 
exclusively for the purpose of furnishing items and services related to

[[Page 70336]]

the administration of the home infusion drug, the home health agency 
would submit a home infusion therapy services claim under the home 
infusion therapy services benefit. If the home visit includes the 
provision of other home health services in addition to, and separate 
from, home infusion therapy services, the home health agency would 
submit both a home health claim under the HH PPS and a home infusion 
therapy services claim under the home infusion therapy services 
benefit. However, the agency must separate the time spent furnishing 
services covered under the HH PPS from the time spent furnishing 
services covered under the home infusion therapy services benefit. DME 
is excluded from the consolidated billing requirements governing the HH 
PPS (42 CFR 484.205) and therefore, the DME items and services 
(including the home infusion drug and related services) will continue 
to be paid for outside of the HH PPS. If the qualified home infusion 
therapy supplier is not the same entity as the home health agency 
furnishing the home health services, the home health agency would 
continue to bill under the HH PPS on the home health claim, and the 
qualified home infusion therapy supplier would bill for the services 
related to the administration of the home infusion drugs on the home 
infusion therapy services claim.
    The summarized comments and responses related to the separation of 
home infusion therapy services benefit from the HH PPS are found in 
section V.A.5 .
(b) Notification of Infusion Therapy Options Available Prior To 
Furnishing Home Infusion Therapy Services
    Section 1834(u)(6) of the Act requires that prior to the furnishing 
of home infusion therapy services to an individual, the physician who 
establishes the plan described in section 1861(iii)(1) of the Act for 
the individual shall provide notification (in a form, manner, and 
frequency determined appropriate by the Secretary) of the options 
available (such as home, physician's office, hospital outpatient 
department) for the furnishing of infusion therapy under this part.
    We recognize there are several possible forms, manners, and 
frequencies that physicians may use to notify patients of their 
infusion therapy options. We solicited comments in the CY 2020 PFS 
proposed rule (84 FR 40716) and the CY 2020 HH PPS proposed rule (84 FR 
34694), regarding the appropriate form, manner, and frequency that any 
physician must use to provide notification of the treatment options 
available to his/her patient for the furnishing of infusion therapy 
(home or otherwise) under Medicare Part B. We also invited comments on 
any additional interpretations of this notification requirement. We 
summarized the comments received in the CY 2020 PFS final rule (84 FR 
62568) and the CY 2020 HH PPS final rule with comment period (84 FR 
60478), and we stated we would take these comments into consideration 
as we continue developing future policy through notice-and-comment 
rulemaking.
    Many commenters stated that physicians already routinely discuss 
the infusion therapy options with their patients and annotate these 
discussions in their patients' medical records. For home infusion 
therapy services effective beginning CY 2021, physicians are to 
continue with the current practice of discussing options available for 
furnishing infusion therapy under Part B and annotating these 
discussions in their patients' medical records prior to establishing a 
home infusion therapy plan of care. We did not propose to create a 
mandatory form nor did we otherwise propose to require a specific 
manner or frequency of notification of options available for infusion 
therapy under Part B prior to establishing a home infusion therapy plan 
of care, as we believe that current practice provides appropriate 
notification. However, we stated that if current practice is later 
found to be insufficient in providing appropriate notification to 
patients of the available infusion options under Part B, we might 
consider additional requirements regarding this notification in future 
rulemaking.
    Comment: One commenter supported the current practice of physicians 
discussing all infusion therapy options with their patients, especially 
in regard to understanding the costs.
    Response: We appreciate the commenter's support of maintaining this 
current practice.
    Final Decision: At this time, we will not create a mandatory form 
nor require a specific manner or frequency of notification of options 
available for infusion therapy under Part B prior to establishing a 
home infusion therapy plan of care, as we believe that current practice 
provides appropriate notification. However, if current practice is 
later found to be insufficient in providing appropriate notification to 
patients of the available infusion options under Part B, we may 
consider additional requirements regarding this notification in future 
rulemaking.
3. Payment Categories and Payment Amounts for Home Infusion Therapy 
Services for CY 2021
    Section 1834(u)(1) of the Act provides the authority for the 
development of a payment system for Medicare-covered home infusion 
therapy services. In accordance with section 1834(u)(1)(A)(i) of the 
Act, the Secretary is required to implement a payment system under 
which a single payment is made to a qualified home infusion therapy 
supplier for items and services furnished by a qualified home infusion 
therapy supplier in coordination with the furnishing of home infusion 
drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit of 
single payment under this payment system is for each infusion drug 
administration calendar day in the individual's home, and requires the 
Secretary, as appropriate, to establish single payment amounts for 
different types of infusion therapy, taking into account variation in 
utilization of nursing services by therapy type. Section 
1834(u)(1)(A)(iii) of the Act provides a limitation to the single 
payment amount, requiring that it shall not exceed the amount 
determined under the PFS (under section 1848 of the Act) for infusion 
therapy services furnished in a calendar day if furnished in a 
physician office setting. Furthermore, such single payment shall not 
reflect more than 5 hours of infusion for a particular therapy in a 
calendar day. This permanent payment system would become effective for 
home infusion therapy items and services furnished on or after January 
1, 2021.
    In accordance with section 1834(u)(1)(A)(ii) of the Act, a unit of 
single payment for each infusion drug administration calendar day in 
the individual's home must be established for types of infusion 
therapy, taking into account variation in utilization of nursing 
services by therapy type. Furthermore, section 1834(u)(1)(B)(ii) of the 
Act requires that the payment amount reflect factors such as patient 
acuity and complexity of drug administration. We believe that the best 
way to establish a single payment amount that varies by utilization of 
nursing services and reflects patient acuity and complexity of drug 
administration, is to group home infusion drugs by J-code into payment 
categories reflecting similar therapy types. Therefore, each payment 
category would reflect variations in infusion drug administration 
services.
    Section 1834(u)(7)(C) of the Act established three payment 
categories, with the associated J-code for each transitional home 
infusion drug (see

[[Page 70337]]

Table 13), for the home infusion therapy services temporary 
transitional payment. Payment category 1 comprises certain intravenous 
infusion drugs for therapy, prophylaxis, or diagnosis, including, but 
not limited to, antifungals and antivirals; inotropic and pulmonary 
hypertension drugs; pain management drugs; and chelation drugs. Payment 
category 2 comprises subcutaneous infusions for therapy or prophylaxis, 
including, but not limited to, certain subcutaneous immunotherapy 
infusions. Payment category 3 comprises intravenous chemotherapy 
infusions, including certain chemotherapy drugs and biologicals.
(a) CY 2021 Payment Categories for Home Infusion Therapy Services
    In the CY 2020 HH PPS final rule with comment period (84 FR 60478), 
we finalized our proposal to maintain the three payment categories 
utilized under the temporary transitional payments for home infusion 
therapy services. Maintaining the three current payment categories, 
with the associated J-codes as set out at section 1834(u)(7)(C) of the 
Act, utilizes an already established framework for assigning a unit of 
single payment (per category), accounting for different therapy types, 
as required by section 1834(u)(1)(A)(ii) of the Act. The payment amount 
for each of these three categories is different, though each category 
has its associated single payment amount. The single payment amount 
(per category) would thereby reflect variations in nursing utilization, 
complexity of drug administration, and patient acuity, as determined by 
the different categories based on therapy type. Retaining the three 
current payment categories maintains consistency with the already 
established payment methodology and ensures a smooth transition between 
the temporary transitional payments and the permanent payment system to 
be implemented beginning in 2021.
    Table 13 provides the list of J-codes associated with the infusion 
drugs that fall within each of the payment categories. There are some 
drugs that are paid for under the transitional benefit but would not be 
defined as a home infusion drug under the permanent benefit beginning 
with 2021. Section 1861(iii)(3)(C) of the Act defines a home infusion 
drug as a parenteral drug or biological administered intravenously or 
subcutaneously for an administration period of 15 minutes or more, in 
the home of an individual through a pump that is an item of DME. Such 
term does not include the following: (1) Insulin pump systems; and (2) 
a self-administered drug or biological on a self-administered drug 
exclusion list. Hizentra[supreg], a subcutaneous immunoglobulin, is not 
included in this definition of ``home infusion drugs'' because it is 
listed on a self-administered drug (SAD) exclusion list by the MACs. 
This drug was included as a transitional home infusion drug since the 
definition of such drug in section 1834(u)(7)(A)(iii) of the Act does 
not exclude self-administered drugs or biologicals on a SAD exclusion 
list under the temporary transitional payment. Therefore, although home 
infusion therapy services related to the administration of 
Hizentra[supreg] are covered under the temporary transitional payment, 
because it is currently on a SAD exclusion list, services related to 
the administration of this biological are not covered under the benefit 
in 2021; however, if it is removed from all the SAD lists, it could be 
added to the home infusion drugs list in the future. Similarly, in 
accordance with the definition of ``home infusion drug'' as a 
parenteral drug or biological administered intravenously or 
subcutaneously, home infusion therapy services related to the 
administration of ziconotide and floxuridine are also excluded, as 
these drugs are given via intrathecal and intra-arterial routes 
respectively and therefore do not meet the definition of ``home 
infusion drug''. Likewise, home infusion therapy services related to 
the intrathecal administration of morphine, identified by HCPCS code 
J2274, is excluded because intrathecal administration does not meet the 
definition of a ``home infusion drug'' under the permanent benefit.
    It is important to note that the list of home infusion drugs is 
maintained by the DME MACs and the drugs or their respective payment 
categories do not need to be updated through rulemaking every time a 
new drug is added to the DME LCD for External Infusion Pumps 
(L33794).\20\ We acknowledge, however, that two immune-globulins, 
Xembify[supreg] and Cutaquig[supreg], have been added to the DME LCD 
for External Infusion Pumps (L33794).\21\ Consistent with the 
definition of ``home infusion drug'', the home infusion therapy 
services will be covered under payment category 2 for these two 
subcutaneously infused drugs. Xembify[supreg] is identified by HCPCS 
code J1558 and Cutaquig[supreg] is currently identified by the not 
otherwise classified (NOC) code J7799 until it is assigned a unique 
HCPCS code.
---------------------------------------------------------------------------

    \20\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
    \21\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
---------------------------------------------------------------------------

    The payment category may be determined by the DME MAC for any 
subsequent home infusion drug additions to the DME LCD for External 
Infusion Pumps (L33794) \22\ as identified by the following NOC codes: 
J7799 (Not otherwise classified drugs, other than inhalation drugs, 
administered through DME) and J7999 (Compounded drug, not otherwise 
classified). Payment category 1 would include any appropriate 
subsequent intravenous infusion drug additions, payment category 2 
would include any appropriate subsequent subcutaneous infusion drug 
additions, and payment category 3 would include any appropriate 
subsequent intravenous chemotherapy or other highly complex drug or 
biologic infusion additions.
---------------------------------------------------------------------------

    \22\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.

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[[Page 70338]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.013

    Comment: We received comments expressing concerns regarding home 
infusions of the cytotoxic chemotherapy drugs that are on the list of 
home infusion drugs, especially if they are mishandled or administered 
incorrectly. Commenters noted that certain safety standards that exist 
for outpatient clinics may be difficult to satisfy when infusing such 
drugs in the home environment and thus infusing such drugs at home 
could potentially put patients and health care personnel at increased 
risk of dangerous adverse effects such as genotoxicity, teratogenicity, 
acute anaphylactic reactions, carcinogenicity, and reproductive risks 
for patients and the potential for mishandling of the drugs by health 
care personnel among others. We also received comments with requests 
for the current list of transitional home infusion drugs to be 
grandfathered into the list of home infusion drugs for the permanent 
benefit in effort to continue payment for services related to certain 
drugs, such as Hizentra[supreg] and ziconotide, which do not meet the 
definition of ``home infusion drugs'' according to section 
1861(iii)(3)(C) of the Act. Other comments suggested adding certain 
antibiotics and central nervous system agents to the list of home 
infusion drugs, especially in consideration for beneficiaries whose 
previous commercial insurance may have covered home infusion services 
related to such drugs. Many commenters specifically suggested including 
two subcutaneously infused immune-globulins, Xembify[supreg] and 
Cutaquig[supreg], on

[[Page 70339]]

the list of home infusion drugs. Another commenter suggested revising 
the requirement that home infusion drugs must be identified by the DME 
LCD for External Infusion Pumps (L33794) \23\ in an effort to expand 
the list of home infusion drugs more quickly than via the existing LCD 
reconsideration process.
---------------------------------------------------------------------------

    \23\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
---------------------------------------------------------------------------

    Response: We appreciate the commenters' interests and concerns 
regarding the drugs associated with the permanent home infusion therapy 
services benefit, however, the home infusion therapy services benefit 
does not cover drugs, as they are covered under the durable medical 
equipment benefit. Rather, the home infusion therapy services benefit 
covers the professional services associated with drugs that meet the 
definition of home infusion drugs and are identified in the DME LCD for 
External Infusion Pumps (L33794).\24\ We discussed the LCD Development 
Process in the CY 2020 HH PPS final rule in order to provide 
transparency to stakeholders on the criteria and process used to 
determine which items are included on the LCD for External Infusion 
Pumps (84 FR 60619). Any requests regarding additions to the DME LCD 
for External Infusion Pumps must be made to the DME MACs. Finally, as 
previously discussed, Xembify[supreg] and Cutaquig[supreg] were 
recently added to the DME LCD for External Infusion Pumps (L33794) \25\ 
and meet the definition of a home infusion drug with coverage of home 
infusion therapy services under payment category 2.
---------------------------------------------------------------------------

    \24\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
    \25\ Local Coverage Determination (LCD): External Infusion Pumps 
(L33794). https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD+and+PA.
---------------------------------------------------------------------------

    Final Decision: We did not propose any changes, therefore we are 
maintaining the current definition of ``home infusion drugs'' as 
finalized in the CY 2020 HH PPS final rule with comment period (84 FR 
60618), pursuant to the statutory definition set out at section 
1861(iii)(3)(C) of the Act, and incorporated by cross reference at 
section 1834(u)(7)(A)(iii) of the Act.
(b) CY 2021 Payment Amounts for Home Infusion Therapy Services
    Section 1834(u)(1)(A)(ii) of the Act requires that the payment 
amount take into account variation in utilization of nursing services 
by therapy type. Additionally, section 1834(u)(1)(A)(iii) of the Act 
provides a limitation that the single payment shall not exceed the 
amount determined under the fee schedule under section 1848 of the Act 
for infusion therapy services furnished in a calendar day if furnished 
in a physician office setting, except such single payment shall not 
reflect more than 5 hours of infusion for a particular therapy in a 
calendar day. Finally, section 1834(u)(1)(B)(ii) of the Act requires 
the payment amount to reflect patient acuity and complexity of drug 
administration.
    Currently, as set out at section 1834(u)(7)(D) of the Act, each 
temporary transitional payment category is paid at amounts in 
accordance with six infusion CPT codes and units of such codes under 
the PFS. These payment category amounts are set equal to 4 hours of 
infusion therapy administration services in a physician's office for 
each infusion drug administration calendar day, regardless of the 
length of the visit. In the CY 2020 HH PPS final rule with comment 
period (84 FR 60478), we finalized that the payment amounts per 
category, for an infusion drug administration calendar day under the 
permanent benefit, be in accordance with the six PFS infusion CPT codes 
and units for such codes, as described in section 1834(u)(7)(D) of the 
Act. However, we set the amount equivalent to 5 hours of infusion in a 
physician's office, rather than 4 hours. Each payment category amount 
would be in accordance with the six infusion CPT codes identified in 
section 1834(u)(7)(D) of the Act and as shown in Table 14.
[GRAPHIC] [TIFF OMITTED] TR04NO20.014

    We also finalized the proposal to increase the payment amounts for 
each of the three payment categories for the first home infusion 
therapy visit by the qualified home infusion therapy supplier in the 
patient's home by the average difference between the PFS amounts for E/
M existing patient visits and new patient visits for a given year, 
resulting in a small decrease to the payment amounts for the second and 
subsequent visits, using a budget neutrality factor. Effective January 
1, 2021 there are changes to the office/outpatient E/M visit code set 
(CPT codes

[[Page 70340]]

99201 through 99215) used to calculate the initial and subsequent visit 
payment amounts for home infusion. These changes were adopted from the 
new coding, prefatory language, and interpretive guidance framework 
that has been issued by the AMA's CPT Editorial Panel (see https://www.amaassn.org/practice-management/cpt/cptevaluation-and-management) 
and include the deletion of code 99201 (Level 1 office/outpatient 
visit, new patient), and new values for CPT codes 99202 through 99215. 
The initial visit percentage increase will still be calculated using 
the average difference between the PFS amounts for E/M existing patient 
visits and new patient visits for a given year; however, now only new 
patient E/M codes 99202 through 99205 will be used in the calculation. 
Using the proposed CY 2021 PFS rates, we estimate a 19 percent increase 
in the first visit payment amount and a 1.18 percent decrease in 
subsequent visit amounts. Table 15 shows the updated E/M visit codes 
and proposed PFS payment amounts for CY 2021, for both new and existing 
patients, used to determine the increased payment amount for the first 
visit. The final CY 2021 PFS amounts for E/M visits were not available 
at the time of publication for this final rule; however, we will post 
the final home infusion therapy services payment amounts on the PFS 
rate setting update.
[GRAPHIC] [TIFF OMITTED] TR04NO20.015

    Table 16 shows the 5-hour payment amounts (using proposed CY 2021 
PFS rates) reflecting the increased payment for the first visit and the 
decreased payment for all subsequent visits. The payment amounts for 
this final rule are estimated using the proposed CY 2021 rates because 
the final CY 2021 PFS rates are not available at the time of this rule 
making. The final home infusion 5-hour payment amounts will be released 
on the Physician Fee Schedule when the final CY 2021 PFS rates are 
posted. We plan on monitoring home infusion therapy service lengths of 
visits, both initial and subsequent, in order to evaluate whether the 
data substantiates this increase or whether we should re-evaluate 
whether, or how much, to increase the initial visit payment amount.
[GRAPHIC] [TIFF OMITTED] TR04NO20.016

    We did not propose any new policies related to the HIT services 
payment system, and did not receive any specific comments on the 
payment amounts posted in the proposed rule.
    Final Decision: The payment policies for the permanent home 
infusion therapy services benefit were finalized in the CY 2020 HH PPS 
final rule with comment period (84 FR 60478). We will maintain the 
three payment categories currently being utilized under the temporary 
transitional payments for home infusion therapy services and each 
category payment amount will be

[[Page 70341]]

in accordance with the six CPT infusion codes under the PFS and equal 
to 5 hours of infusion services in a physician's office. We will 
increase the payment amounts for each of the three payment categories 
for the first visit by the relative payment for a new patient rate over 
an existing patient rate using the Medicare physician evaluation and 
management (E/M) payment amounts for a given year, in a budget neutral 
manner, resulting in a small decrease to the payment amounts for any 
subsequent visits. Payment will be made for each infusion drug 
administration calendar day in accordance with the definition finalized 
in the CY 2019 final rule with comment period (83 FR 56583).
4. Payment Adjustments for CY 2021 Home Infusion Therapy Services
(a) Home Infusion Therapy Geographic Wage Index Adjustment
    Section 1834(u)(1)(B)(i) of the Act requires that the single 
payment amount be adjusted to reflect a geographic wage index and other 
costs that may vary by region. In the 2020 HH PPS final rule with 
comment period (84 FR 60478, 60629) we finalized the use of the 
Geographic Adjustment Factor (GAF) to adjust home infusion therapy 
payments based on differences in geographic wages. The GAF is a 
weighted composite of each PFS locality's work, practice expense (PE), 
and malpractice (MP) Geographic Price Cost Index (GPCIs) and represents 
the combined impact of the three GPCI components. The GAF is calculated 
by multiplying the work, PE, and MP GPCIs by the corresponding national 
cost share weight: work (50.886 percent), PE (44.839 percent), and MP 
(4.295 percent).\26\ The GAF is not specific to any of the home 
infusion drug categories, so the GAF payment rate would equal the 
unadjusted rate multiplied by the GAF for each locality level, without 
a labor share adjustment. As such, based on locality, the GAF adjusted 
payment rate would be calculated using the following formula:
---------------------------------------------------------------------------

    \26\ GAF = (0.50886 x Work GPCI) + (0.44839 x PE GPCI) + 
(0.04295 x MP GPCI).
[GRAPHIC] [TIFF OMITTED] TR04NO20.021

    The appropriate GAF value is applied to the home infusion therapy 
single payment amount based on the site of service of the beneficiary 
and the adjustment will happen on the PFS based on the beneficiary zip 
code submitted on the 837P/CMS-1500 professional and supplier claims 
form. We finalized that the application of the GAF will be budget 
neutral so there is no overall cost impact. However, this will result 
in some adjusted payments being higher than the average and others 
being lower. In order to make the application of the GAF budget neutral 
we will apply a budget-neutrality factor. If the rates were set using 
the proposed CY 2021 PFS rates the budget neutrality factor would be 
0.9951. The GAF conversion factor equals the ratio of the estimated 
unadjusted national spending total to the estimated GAF-adjusted 
national spending total. Estimates of national spending totals are 
derived from a function of ``beneficiary counts,'' ``weeks of care,'' 
and ``estimated visits of care'' by home infusion therapy drug payment 
category, which were compiled from CY 2019 utilization data. We define 
home infusion therapy beneficiaries as Medicare beneficiaries with at 
least one home infusion therapy drug prescription fill in CY 2019, and 
weeks of care for each home infusion therapy beneficiary equal the 
number of weeks between (and including) the first prescription fill in 
CY 2019 and the last prescription fill in CY2019. Weeks of care are 
then transformed into ``estimated visits of care,'' where we assumed 2 
visits for the initial week of care, with 1 visit per week for all 
subsequent weeks for categories 1 and 3, and we assumed 1 visit per 
month, or 12 visits per year, for category 2.
    The list of GAFs by locality for this final rule is available as a 
downloadable file at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html.
(b) Consumer Price Index
    Subparagraphs (A) and (B) of section 1834(u)(3) of the Act specify 
annual adjustments to the single payment amount that are required to be 
made beginning January 1, 2022. In accordance with these sections we 
would increase the single payment amount by the percent increase in the 
Consumer Price Index for all urban consumers (CPI-U) for the 12-month 
period ending with June of the preceding year, reduced by the 10-year 
moving average of changes in annual economy-wide private nonfarm 
business multifactor productivity (MFP). Accordingly, this may result 
in a percentage being less than 0.0 for a year, and may result in 
payment being less than such payment rates for the preceding year.
    We did not propose any new policies related to the payment 
adjustments for HIT services, and did not receive any specific comments 
on the use of the GAF or the CPI-U.
    Final Decision: As finalized in the CY 2020 HH PPS final rule (84 
FR 60630), we will use the GAF to geographically adjust the home 
infusion therapy payment amounts in CY 2021 and subsequent calendar 
years. And beginning in CY 2022, we will annually update the single 
payment amount from the prior year for each home infusion therapy 
payment category by the percent increase in the Consumer Price Index 
for all urban consumers (CPI-U) for the 12-month period ending with 
June of the preceding year, reduced by the 10-year moving average of 
changes in annual economy-wide private nonfarm business multifactor 
productivity (MFP) as required by section 1834(u)(3) of the Act.
5. Home Infusion Therapy Services Excluded From the Medicare Home 
Health Benefit
    In the CY 2021 proposed rule (85 FR 39440) we discussed the 
services covered under the home infusion therapy services benefit as 
defined under section 1861(iii) of the Act. This section defines ``home 
infusion therapy'' as the items and services described in paragraph 
(2), furnished by a qualified home infusion therapy supplier which are 
furnished in the individual's home. In accordance with Sec.  486.525, 
the required items and services covered under the home infusion therapy 
services benefit are as follows:
     Professional services, including nursing services, 
furnished in accordance with the plan.
     Training and education (not otherwise paid for as DME).
     Remote monitoring, and monitoring services for the 
provision of home infusion drugs furnished by a qualified home infusion 
therapy supplier.
    We also noted that the CY 2019 HH PPS proposed rule described the 
professional and nursing services, as well as the training, education, 
and monitoring services included in the payment to a qualified home 
infusion therapy supplier for the provision of home infusion drugs (83 
FR 32467). Additionally, while we did not outline an exhaustive list of 
services that are covered under the home infusion therapy services 
benefit, we did outline the scope of services covered under the home 
infusion therapy services benefit in sub-regulatory guidance.\27\ This

[[Page 70342]]

guidance states that the home infusion therapy services benefit is 
intended to be a separate payment explicitly covering the professional 
services, training and education (not covered under the DME benefit), 
and monitoring and remote monitoring services for the provision of home 
infusion drugs. We state that these services may include, for example 
the following:
---------------------------------------------------------------------------

    \27\ MLN Matters: SE19029: Medicare Part B Home Infusion Therapy 
Services With the Use of Durable Medical Equipment. December 13, 
2019. https://www.cms.gov/files/document/se19029.pdf. And Temporary 
Transitional Payment FAQs. February 27, 2019. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Downloads/Home-Infusion-Therapy-Services-Temp-Transitional-Payment-FAQs.pdf.
---------------------------------------------------------------------------

     Training and education on care and maintenance of vascular 
access devices--
    ++ Hygiene Education;
    ++ Instruction on what to do in the event of a dislodgement or 
occlusion;
    ++ Education on signs and symptoms of infection; and
    ++ Teaching and training on flushing and locking the catheter.
     Dressing changes and site care.
     Patient assessment and evaluation--
    ++ Review history and assess current physical and mental status, 
including obtaining vital signs;
    ++ Assess any adverse effects or infusion complications;
    ++ Evaluate family and caregiver support ;
    ++ Review prescribed treatment and any concurrent oral and/or over-
the-counter treatments; and
    ++ Obtain blood for laboratory work
     Medication and disease management education--
    ++ Instruction on self-monitoring;
    ++ Education on lifestyle and nutritional modifications;
    ++ Education regarding drug mechanism of action, side effects, 
interactions with other medications, adverse and infusion-related 
reactions;
    ++ Education regarding therapy goals and progress;
    ++ Instruction on administering pre-medications and inspection of 
medication prior to use;
    ++ Education regarding household and contact precautions and/or 
spills;
     Remote monitoring services.
     Monitoring services--
    ++ Communicate with patient regarding changes in condition and 
treatment plan;
    ++ Monitor patient response to therapy; and
    ++ Assess compliance.
    We stated that this list is not intended to be prescriptive or all-
inclusive, as the physician is responsible for ordering the reasonable 
and necessary services for the safe and effective administration of the 
home infusion drug.
    In the CY 2021 proposed rule, we also recognized that section 5012 
of the 21st Century Cures Act amended section 1861(m) of the Act to 
exclude home infusion therapy from the definition of home health 
services, effective January 1, 2021 (85 FR 39441). We clarified that 
while patients needing home infusion therapy are not required to be 
eligible for the home health benefit, they are not prohibited from 
utilizing both the home infusion therapy and home health benefits 
concurrently, and that it is likely that many home health agencies will 
become accredited and enroll as qualified home infusion therapy 
suppliers. Therefore, because a home health agency may furnish services 
for a patient receiving both home health services and home infusion 
therapy services, we stated that it is necessary to exclude in 
regulation the scope of professional services, training and education, 
as well as monitoring and remote monitoring services, for the provision 
of home infusion drugs, as defined at Sec.  486.505, from the services 
covered under the home health benefit. We also noted that the home 
infusion therapy services distinct from those which are required and 
furnished under the home health benefit, are only for the provision of 
home infusion drugs. Therefore, when a home health agency is furnishing 
services to a patient receiving an infusion drug not defined as a home 
infusion drug at Sec.  486.505, those services may still be covered as 
home health services.
    In accordance with the conforming amendment in section 5012(c)(3) 
of the 21st Century Cures Act, which amended section 1861(m) of the Act 
to exclude home infusion therapy from the definition of home health 
services, we proposed to amend Sec.  409.49 to exclude services covered 
under the home infusion therapy services benefit from the home health 
benefit. We stated that any services that are covered under the home 
infusion therapy services benefit as outlined at Sec.  486.525, 
including any home infusion therapy services furnished to a Medicare 
beneficiary that is under a home health plan of care, are excluded from 
coverage under the Medicare home health benefit. Additionally, we 
clarified that excluded home infusion therapy services only pertain to 
the items and services for the provision of home infusion drugs, as 
defined at Sec.  486.505. Services for the provision of drugs and 
biologicals not covered under this definition may continue to be 
provided under the Medicare home health benefit, and paid under the 
home health prospective payment system.
    Additionally, in the proposed rule we reiterated the billing 
process as outlined in the CY 2019 HH PPS proposed rule (83 FR 32469). 
We stated that if a patient is under a home health plan of care, and a 
home health visit is furnished that is unrelated to home infusion 
therapy, then payment for the home health visit would be covered by the 
HH PPS and billed on the same home health claim. If the HHA providing 
services under the Medicare home health benefit is also the same entity 
furnishing services as the qualified home infusion therapy supplier, 
and a home visit is exclusively for the purpose of furnishing home 
infusion therapy services, the HHA would submit a claim for payment as 
a home infusion therapy supplier and receive payment under the home 
infusion therapy services benefit. If the home visit includes the 
provision of home health services in addition to, and separate from, 
items and services related to home infusion therapy, the HHA would 
submit both a home health claim and a home infusion therapy services 
claim, and must separate the time spent performing services covered 
under the HH PPS from the time spent performing services covered under 
the home infusion therapy services benefit.
    Collectively, commenters expressed disagreement with the proposal 
to amend Sec.  409.49 to exclude services covered under the home 
infusion therapy services benefit from the home health benefit. The 
following is our response.
    Comment: Commenters suggested that CMS should use its authority to 
not enforce the prohibition for HHAs to provide the professional 
services associated with Part B infusion drugs under the home health 
benefit. Some commenters expressed concern that beneficiaries would 
receive fragmented care from multiple visits from various entities and 
would be required to pay a twenty percent coinsurance for the home 
infusion therapy services benefit when utilizing both concurrently, 
whereas they did not have a coinsurance previously under the home 
health benefit. One commenter expressed concern with the number of 
eligible entities that intend to enroll as home infusion therapy 
suppliers and whether there will be sufficient suppliers enrolled, 
particularly in rural areas. The commenter stated that there may be 
many HHAs that do not enroll as qualified home infusion therapy 
suppliers, and who plan to subcontract with a home infusion therapy 
supplier, but the availability of these suppliers is unknown; 
potentially creating a situation where there may be difficulties in 
finding qualified home infusion therapy suppliers. This commenter 
suggested that some HHAs would then

[[Page 70343]]

be forced to provide unreimbursed care to patients receiving home 
infusion drugs.
    Response: Section 5012 of the 21st Century Cures Act amended 
section 1861(m) of the Act to exclude home infusion therapy services 
from the definition of home health services, effective January 1, 2021, 
therefore, we are statutorily precluded from making payment for home 
infusion therapy services to entities other than ``qualified home 
infusion therapy suppliers'' for services needed to administer ``home 
infusion drugs.'' As described in section V.B of the proposed rule (85 
FR 39442), the overarching purpose of the enrollment process is to help 
ensure that providers and suppliers that seek to bill the Medicare 
program for services or items furnished to Medicare beneficiaries are 
qualified to do so under federal and state laws. This process helps to 
prevent unqualified and potentially fraudulent individuals and entities 
from being able to enter and inappropriately bill Medicare. Therefore, 
an HHA must be accredited and enrolled in Medicare as a qualified home 
infusion therapy supplier in order to furnish and bill for home 
infusion therapy services under the home infusion therapy services 
benefit, which is statutorily required to be implemented by January 1, 
2021. If an HHA does not become accredited and enrolled as a qualified 
home infusion therapy supplier and is treating a patient receiving a 
home infusion drug, the HHA must contract with a qualified home 
infusion therapy supplier to furnish the services related to the home 
infusion drug.
    As we noted in the CY 2020 HH PPS final rule (84 FR 60624), it is 
already the responsibility of the HHA to arrange for the DME and 
related infusion services for patients under a home health plan of 
care. In accordance with the Medicare HH CoPs at 42 CFR 484.60, the 
home health agency must assure communication with all physicians 
involved in the plan of care, as well as integrate all orders and 
services provided by all physicians and other healthcare disciplines, 
such as nursing, rehabilitative, and social services. If the HHA also 
becomes accredited and enrolls in Medicare as a qualified home infusion 
therapy supplier, the HHA can either continue to furnish the services 
or contract with a qualified home infusion therapy supplier to meet 
these requirements. It is also important to note that the HHA can still 
provide all infusion services to patients under the home health benefit 
as home health services, for any drugs not considered home infusion 
drugs.
    Final Decision: In accordance with the conforming amendment in 
section 5012(c)(3) of the 21st Century Cures Act, which amended section 
1861(m) of the Act to exclude home infusion therapy from the definition 
of home health services, we are finalizing as proposed our amendment to 
Sec.  409.49 to exclude services covered under the home infusion 
therapy services benefit from the home health benefit. Any services 
that are covered under the home infusion therapy services benefit as 
outlined at Sec.  486.525, including any home infusion therapy services 
furnished to a Medicare beneficiary that is under a home health plan of 
care, are excluded from coverage under the Medicare home health 
benefit. Excluded home infusion therapy services only pertain to the 
items and services for the provision of home infusion drugs, as defined 
at Sec.  486.505. Services for the provision of drugs and biologicals 
not covered under this definition may continue to be provided under the 
Medicare home health benefit, and paid under the home health 
prospective payment system.

B. Enrollment Requirements for Qualified Home Infusion Therapy 
Suppliers

    As previously alluded to, regulatory provisions pertaining to home 
infusion therapy have been established in various parts of Title 42 of 
the CFR, such as in part 414, subpart P and in part 486, subpart I. 
Sections 486.520 and 486.525 outline standards for home infusion 
therapy while Sec.  486.505 defines ``qualified home infusion therapy 
supplier.'' This latter term means 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:
     Furnishes infusion therapy to individuals with acute or 
chronic conditions requiring administration of home infusion drugs.
     Ensures the safe and effective provision and 
administration of home infusion therapy on a 7-day-a-week, 24-hour-a-
day basis.
     Is accredited by an organization designated by the 
Secretary in accordance with section 1834(u)(5) of the Act.
     Meets such other requirements as the Secretary determines 
appropriate.
    Concerning this final criterion (which reflects section 
1861(iii)(3)(D)(i)(IV) of the Act), one of CMS' principal oversight 
roles is to protect the Medicare program from fraud, waste, and abuse. 
This is accomplished in part through the careful screening and 
monitoring of prospective and existing providers and suppliers. In our 
view, section 1861(iii)(3)(D)(i)(IV) of the Act permits the Secretary 
to take steps in this direction with respect to home infusion therapy 
suppliers.
1. Background--Provider and Supplier Enrollment Process
    Section 1866(j)(1)(A) of the Act requires the Secretary to 
establish a process for the enrollment of providers and suppliers in 
the Medicare program. The overarching purpose of the enrollment process 
is to help confirm that providers and suppliers seeking to bill 
Medicare for services and items furnished to Medicare beneficiaries 
meet all federal and state requirements to do so. The process is, to an 
extent, a ``gatekeeper'' that prevents unqualified and potentially 
fraudulent individuals and entities from being able to enter and 
inappropriately bill Medicare.
    Since 2006, we have taken various steps via rulemaking to outline 
our enrollment procedures. These regulations are generally incorporated 
in 42 CFR part 424, subpart P (currently Sec. Sec.  424.500 through 
424.570 and hereinafter occasionally referenced as subpart P). They 
address, among other things, requirements that providers and suppliers 
must meet to obtain and maintain Medicare billing privileges. One such 
requirement (outlined in Sec.  424.510) is that the provider or 
supplier must complete, sign, and submit to its assigned Medicare 
Administrative Contractor (MAC) the appropriate Form CMS-855 (OMB 
Control No. 0938-0685). The Form CMS-855, which can be submitted via 
paper or electronically through the internet-based Provider Enrollment, 
Chain, and Ownership System (PECOS) process (SORN: 09-70-0532, Provider 
Enrollment, Chain, and Ownership System) collects important information 
about the provider or supplier; such data includes, but is not limited 
to, general identifying information (for example, legal business name), 
licensure and/or certification data, and practice locations. After 
receiving the provider's or supplier's initial enrollment application, 
reviewing and confirming the information thereon, and determining 
whether the provider or supplier meets all applicable Medicare 
requirements, CMS or the MAC will either: (1) Approve the application 
and grant billing privileges to the provider or supplier (or, depending 
upon the provider or supplier type involved, simply recommend approval 
of the application and refer it to the state agency or to the CMS 
regional office, as applicable); or (2) deny enrollment under Sec.  
424.530.

[[Page 70344]]

    We believe the Medicare provider and supplier enrollment screening 
process has greatly assisted CMS in executing its responsibility to 
prevent Medicare waste and abuse. As emphasized in the June 30, 2020 
proposed rule, we believe the safeguards that Medicare enrollment 
furnishes are equally needed with respect to home infusion therapy 
suppliers.
2. Legal Bases for Home Infusion Therapy Supplier Enrollment
    There are several legal bases for our proposed home infusion 
therapy supplier enrollment requirements. First, section 5012 of the 
Cures Act, which amended sections 1834(u), 1861(s)(2), and 1861(iii) of 
the Act, established a new Medicare home infusion therapy benefit. 
Second, section 1861(iii)(3)(D)(i)(IV) of the Act permits the Secretary 
to establish requirements for qualified home infusion therapy suppliers 
that the Secretary determines appropriate. In doing so, the Secretary 
shall take into account the standards of care for home infusion therapy 
established by Medicare Advantage plans under Part C and in the private 
sector. (However, we interpret this latter provision to apply strictly 
to the establishment of standards of care as opposed to the creation of 
enrollment requirements for home infusion therapy suppliers.) Third, 
section 1866(j) of the Act provides specific authority with respect to 
the enrollment process for providers and suppliers. Fourth, sections 
1102 and 1871 of the Act furnish general authority for the Secretary to 
prescribe regulations for the efficient administration of the Medicare 
program.
3. Proposed Provisions
    This section of this final rule outlines the proposed enrollment 
requirements for suppliers of home infusion therapy.
a. Definition
    We proposed to establish a new Sec.  424.68 that would encapsulate 
the preponderance of our home infusion therapy supplier enrollment 
provisions. In paragraph (a) thereof, we proposed to define ``home 
infusion therapy supplier'' (for purposes of Sec.  424.68) as a 
supplier of home infusion therapy that meets all of the following 
requirements:
    ++ Furnishes infusion therapy to individuals with acute or chronic 
conditions requiring administration of home infusion drugs.
    ++ Ensures the safe and effective provision and administration of 
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
    ++ Is accredited by an organization designated by the Secretary in 
accordance with section 1834(u)(5) of the Act.
    ++ Is enrolled in Medicare as a home infusion therapy supplier 
consistent with the provisions of Sec.  424.68 and part 424, subpart P.
b. General Enrollment and Payment Requirement
    In paragraph (b), we proposed that for a supplier to receive 
Medicare payment for the provision of home infusion therapy supplier 
services, the supplier must: (1) Qualify as a home infusion therapy 
supplier (as defined in Sec.  424.68); and (2) be in compliance with 
all applicable provisions of Sec.  424.68 and part 424, subpart P. 
(Proposed paragraph (b) would achieve consistency with Sec.  424.505, 
which states that all providers and suppliers seeking to bill Medicare 
must enroll in Medicare and adhere to all of subpart P's enrollment 
requirements.)
c. Specific Requirements for Home Infusion Therapy Supplier Enrollment
(1) Submission of Form CMS-855 and Certification
    In Sec.  424.68(c)(1)(i), we proposed that a home infusion therapy 
supplier must complete in full and submit the Form CMS-855B application 
(``Medicare Enrollment Application: Clinics/Group Practices and Certain 
Other Suppliers'') (OMB Control No.: 0938-0685), or its electronic or 
successor application, to its applicable Medicare contractor. The Form 
CMS-855B is typically completed by suppliers other than individual 
physicians and practitioners. We thus believed that the Form CMS-855B 
was the most suitable enrollment application for home infusion therapy 
suppliers.
    In Sec.  424.68(c)(1)(ii), we proposed that the home infusion 
therapy supplier must certify via the Form CMS-855B that it meets and 
will continue to meet the specific requirements and standards for 
enrollment described in Sec.  424.68 and part 424, subpart P. This was 
to help ensure that the home infusion therapy supplier fully 
understands its obligation to maintain constant compliance with the 
requirements associated with enrollment.
(2) Payment of Application Fee
    Under Sec.  424.514, prospective and revalidating institutional 
providers that are submitting an enrollment application generally must 
pay the applicable application fee. (For CY 2020, the fee amount is 
$595.) In Sec.  424.502, we define an institutional provider as any 
provider or supplier that submits a paper Medicare enrollment 
application using the Form CMS-855A, Form CMS-855B (not including 
physician and non-physician practitioner organizations, which are 
exempt from the fee requirement if they are enrolling as a physician or 
non-physician practitioner organization), Form CMS-855S, Form CMS-
20134, or an associated internet-based PECOS enrollment application. 
Since a home infusion therapy supplier would need to complete the Form 
CMS-855B to enroll in Medicare as such (and would not be enrolling as a 
physician/non-physician organization), we believed that a home infusion 
therapy supplier would meet the definition of an institutional provider 
at Sec.  424.502. Therefore, we proposed in Sec.  424.68(c)(2) that a 
home infusion therapy supplier would be subject to the application fee 
requirements of Sec.  424.514.
(3) Accreditation
    Consistent with section 1861(iii)(3)(D)(i)(III) of the Act 
(codified in Sec.  486.505), we proposed in new Sec.  424.68(c)(3) that 
a home infusion therapy supplier must be currently and validly 
accredited as such by a CMS-recognized home infusion therapy supplier 
accreditation organization in order to enroll and remain enrolled in 
Medicare.
(4) Home Infusion Therapy Supplier Standards
    Certain provisions in part 486, subpart I, and in part 414, subpart 
P, outline important quality standards and conditions of payment 
applicable to home infusion therapy suppliers. To help tie these 
requirements to the home infusion therapy supplier enrollment process, 
we proposed the following:
     In new Sec.  424.68(c)(4), we proposed that in order to 
enroll and maintain enrollment as a home infusion therapy supplier, the 
latter must be compliant with Sec.  414.1515 and all provisions of 42 
CFR part 486, subpart I.
     In Sec.  414.1505, we proposed to add a new paragraph (c) 
stating that, along with the requirements for home infusion therapy 
payment in paragraphs Sec.  414.1505(a) and (b), the home infusion 
therapy supplier must also be enrolled in Medicare consistent with the 
provisions of Sec.  424.68 and part 424, subpart P.
(5) Categorical Risk Designation
    Section 424.518 addresses enrollment application screening 
categories based on a CMS assessment of the level of risk of fraud, 
waste, and abuse posed by a particular type of provider or supplier. In 
general, the higher the level of risk that a certain provider or 
supplier type

[[Page 70345]]

poses, the greater the level of scrutiny with which CMS screens and 
reviews providers or suppliers within that category.
    There are three categories of screening in Sec.  424.518: limited, 
moderate, and high. Irrespective of which category a provider or 
supplier type falls within, the MAC performs the following screening 
functions upon receipt of an initial enrollment application, a 
revalidation application, or an application to add a new practice 
location:
     Verifies that the provider or supplier meets all 
applicable federal regulations and state requirements for their 
provider or supplier type.
     Conducts state license verifications.
     Conducts database checks on a pre- and post-enrollment 
basis to ensure that providers and suppliers continue to meet the 
enrollment criteria for their provider or supplier type.
    Providers and suppliers at the moderate and high categorical risk 
levels, however, must also undergo a site visit. Furthermore, for those 
in the high categorical risk level, the MAC performs a fingerprint-
based criminal history record check of all individuals with a 5 percent 
or greater direct or indirect ownership interest in the provider or 
supplier.
    As explained in the June 30, 2020 proposed rule, we have no recent 
evidence to suggest that home infusion therapy suppliers (as a supplier 
type) pose an enhanced threat of fraud, waste, or abuse that would 
warrant their placement in the moderate or high screening level. We 
thus proposed to include home infusion therapy suppliers within the 
limited screening category. Our specific regulatory revisions in this 
regard were: (1) Re-designating existing Sec.  424.518(a)(1)(vii) 
through (xvi) as, respectively, Sec.  424.518(a)(1)(viii) through 
(xvii); (2) including home infusion therapy suppliers in revised Sec.  
424.518(a)(vii); and (3) stating in new Sec.  424.68(c)(5) that home 
infusion therapy suppliers must successfully complete the limited 
categorical risk level of screening under Sec.  424.518.
d. Denial of Enrollment and Appeals Thereof
    In new Sec.  424.68(d)(1)(i) and (ii), respectively, we proposed 
that CMS may deny a home infusion therapy supplier's enrollment 
application on either of the following grounds:
     The home infusion therapy supplier does not meet all of 
the requirements for enrollment outlined in Sec.  424.68 and in part 
424, subpart P of this chapter; or
     Any of the reasons for denial of a prospective provider's 
or supplier's enrollment application in Sec.  424.530 applies.
    In new Sec.  424.68(d)(2), we proposed that a home infusion therapy 
supplier may appeal the denial of its enrollment application under 42 
CFR part 498.
e. Continued Compliance, Standards, and Reasons for Revocation
    For reasons identical to those behind Sec.  424.68(c), we proposed 
several provisions in new Sec.  424.68(e).
    In paragraph (e)(1), we proposed that, upon and after enrollment, a 
home infusion therapy supplier--
     Must remain currently and validly accredited as described 
in Sec.  424.68(c)(3); and
     Remains subject to, and must remain in full compliance 
with, all of the provisions of--
    ++ Section 424.68;
    ++ Part 424, subpart P;
    ++ Section 414.1515; and
    ++ Part 486, subpart I.
    In paragraph (e)(2), we proposed that CMS may revoke a home 
infusion therapy supplier's enrollment if--
     The supplier does not meet the accreditation requirements 
as described in Sec.  424.68(c)(3);
     The supplier does not comply with all of the provisions 
of--
    ++ Section 424.68;
    ++ Part 424, subpart P;
    ++ Section 414.1515; and
    ++ Part 486, subpart I; or
     Any of the revocation reasons in Sec.  424.535 applies.
    In new paragraph (e)(3), we proposed that a home infusion therapy 
supplier may appeal the revocation of its enrollment under part 498.
f. Effective and Retrospective Date of Home Infusion Therapy Supplier 
Billing Privileges
    Section 424.520 outlines the effective date of billing privileges 
for certain provider and supplier types that are eligible to enroll in 
Medicare. Section 424.520(d) sets forth the applicable effective date 
for physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, and opioid 
treatment programs. This effective date is the later of: (1) The date 
of filing of a Medicare enrollment application that was subsequently 
approved by a Medicare contractor; or (2) the date that the supplier 
first began furnishing services at a new practice location. In a 
similar vein, Sec.  424.521(a) states that physicians, non-physician 
practitioners, physician and non-physician practitioner organizations, 
ambulance suppliers, and opioid treatment programs may retrospectively 
bill for services when the supplier has met all program requirements 
(including state licensure requirements), and services were provided at 
the enrolled practice location for up to--
     Thirty days prior to their effective date if circumstances 
precluded enrollment in advance of providing services to Medicare 
beneficiaries; or
     Ninety days prior to their effective date if a 
Presidentially-declared disaster under the Robert T. Stafford Disaster 
Relief and Emergency Assistance Act, 42 U.S.C. 5121 through 5206 
(Stafford Act) precluded enrollment in advance of providing services to 
Medicare beneficiaries.
    To clarify the effective date of billing privileges for home 
infusion therapy suppliers and to account for circumstances that could 
prevent a home infusion therapy supplier's enrollment prior to the 
furnishing of Medicare services, we proposed to include newly enrolling 
home infusion therapy suppliers within the scope of both Sec. Sec.  
424.520(d) and 424.521(a). We believed that the effective and 
retrospective billing dates addressed therein achieve a proper balance 
between the need for the prompt provision of home infusion therapy 
services and the importance of ensuring that each prospective home 
infusion therapy enrollee is carefully and closely screened for 
compliance with all applicable requirements.
4. Comments Received and Responses
    We received 12 comments from stakeholders regarding our proposed 
home infusion therapy supplier enrollment requirements. Summaries of 
these comments and our responses thereto are as follows:
    Comment: Several commenters expressed concern that CMS will not 
accept Medicare enrollment applications from home infusion therapy 
suppliers until after this final rule is issued. They stated that this 
will give these suppliers only 2 months to complete the enrollment 
process before the home infusion therapy supplier benefit commences on 
January 1, 2021, thus delaying the provision of these services to 
beneficiaries.
    Response: We recognize the limited timeframe between the issuance 
of this rule and January 1, 2021. However, we cannot accept 
applications from a new Medicare supplier type before any final 
regulatory provisions pertaining thereto have been made public. To 
permit suppliers to submit applications based on proposed regulatory 
provisions could lead to confusion for stakeholders,

[[Page 70346]]

especially if the final rule's provisions ultimately differ from those 
that we proposed. Nevertheless, and as with all incoming provider and 
supplier enrollment applications, Form CMS-855B submissions from home 
infusion therapy suppliers will be processed as expeditiously as 
feasible. We also note that our previously mentioned proposals to 
revise Sec. Sec.  424.520(d) and 424.521(a) would permit home infusion 
therapy suppliers to back bill for certain services furnished prior to 
the date on which the MAC approved the supplier's enrollment 
application.
    Comment: Several commenters stated that a number of home health 
agencies and hospices do not intend to enroll as Part B home infusion 
therapy suppliers. The commenters believed this could result in an 
insufficient number of such suppliers, especially in rural areas.
    Response: We acknowledge the possibility that some entities that 
might otherwise qualify as home infusion therapy suppliers will elect 
not to pursue enrollment as such. This is the entity's independent 
choice. However, based on feedback received from the home infusion 
therapy community, we are confident that an adequate number of 
suppliers will enroll in Medicare, therefore helping to ensure 
beneficiary access to these services.
    Comment: A commenter supported our establishment of measures 
designed to prevent fraudulent and unqualified home infusion therapy 
suppliers from entering Medicare. However, the commenter urged CMS to 
ensure that the measures are reasonable and equitable.
    Response: We appreciate the commenter's support. We emphasize that 
our proposed enrollment requirements (for example, including home 
infusion therapy suppliers within the limited risk screening category 
rather than the moderate or high risk category) were carefully tailored 
to balance the need to protect the Trust Funds and beneficiaries from 
unqualified suppliers with the importance of limiting supplier burden 
to the extent possible.
    Comment: A commenter agreed with CMS' proposal to place home 
infusion therapy suppliers in the limited risk screening category under 
Sec.  424.518.
    Response: We appreciate the commenter's support.
    Comment: Several commenters asked CMS to clarify the specific 
supplier type that the enrolling home infusion therapy supplier should 
indicate on the Form CMS-855B.
    Response: Until the Form CMS-855B is revised to include a specific 
supplier type category for home infusion therapy suppliers, such 
suppliers should, in the appropriate section of the current Form CMS-
855B: (1) Indicate a supplier type of ``Other''; and (2) list ``home 
infusion therapy supplier'' in the space next thereto.
    Comment: A number of commenters requested that CMS outline the 
enrollment and licensure requirements for home infusion therapy 
suppliers that--(1) operate in multiple jurisdictions; and/or (2) 
perform certain services through subcontractors. Regarding the first 
issue, several commenters contended that home infusion therapy 
suppliers should not be required to enroll in each MAC jurisdiction in 
which it performs services; besides being overly burdensome, they 
believed this would require the supplier to have a physical presence in 
each such jurisdiction (and perhaps even in each state that the MAC 
covers). These commenters requested that home infusion therapy 
suppliers be permitted to bill all MACs from a single location: (1) 
Without having to maintain fixed sites in every applicable MAC 
jurisdiction or state; and (2) with a single National Provider 
Identifier (NPI).
    Response: It has long been general provider enrollment policy that 
Medicare providers and suppliers must be enrolled in each MAC 
jurisdiction (and, as applicable, licensed or certified in each state) 
in which it performs services, even if the provider or supplier does 
not have a physical practice location in that MAC and/or state. To 
illustrate, suppose a supplier has a single practice location in State 
X. The supplier sends its personnel out from this site to perform 
services in States X, Y, and Z; each of these states falls within a 
different MAC jurisdiction. The supplier must separately enroll with 
all three MACs if it wishes to receive Medicare payments for services 
provided in States X, Y, and Z. The purpose of this policy is to ensure 
that the applicable MAC can: (1) Verify the provider's or supplier's 
compliance with the state's requirements; and (2) make accurate 
payments. For this important reason, we believe home infusion therapy 
suppliers should be subject to this requirement as well.
    Concerning the maintenance of fixed practice locations in each MAC 
jurisdiction in which services are performed, we recognize that home 
infusion therapy suppliers will often operate out of only one central 
location, with services occasionally furnished in homes located in 
various MAC jurisdictions and/or states. We will issue subregulatory 
guidance to address this issue for home infusion therapy suppliers in 
more detail.
    As for the specific NPI situation the commenters raised, we refer 
the latter to the 2004 NPI Final Rule (https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/NationalProvIdentStand/downloads/NPIfinalrule.pdf), the NPI regulations at 45 CFR part 162, 
subpart D, and the ``Medicare Expectations Subpart Paper'' (the text of 
which is in CMS Publication 100-08, Medicare Program Integrity Manual, 
Chapter 15, section 15.3, at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c15.pdf.) In short, and based 
solely on the very general circumstances the commenters presented, the 
home infusion therapy supplier would not be required to obtain a 
separate NPI for each enrollment application it submits to each Part A/
B MAC. Nonetheless, the facts of each case may differ, and we strongly 
encourage the commenters to review the aforementioned NPI Final Rule, 
NPI regulations, and Medicare Expectations Subpart Paper for more 
detailed guidance on how divergent scenarios should be handled.
    As for home infusion therapy suppliers that subcontract the 
provision of certain services to another party, the enrolled supplier 
is ultimately responsible for ensuring that it meets and operates in 
compliance with all Medicare requirements, enrollment or otherwise.
    Comment: A commenter expressed support for our proposal in Sec.  
424.68(b)(3) that a home infusion therapy supplier must be accredited 
in order to enroll in Medicare.
    Response: We appreciate the commenter's support.
    Comment: Several commenters stated that some pharmacies are 
enrolled in Medicare as suppliers of durable medical equipment, 
prosthetics, orthotics, and supplies (DMEPOS) via the Form CMS-855S 
(OMB Control No. 0938-1056) in order to furnish external infusion pump 
items. (The National Supplier Clearinghouse (NSC) is the Medicare 
contractor that processes Form CMS-855S applications. Durable Medicare 
Equipment Medicare Administrative Contractors (DME MACs) process DMEPOS 
claims.) The commenters requested that such pharmacies also enrolling 
via the Form CMS-855B as home infusion therapy suppliers be able to use 
their existing NPI (that is, the same NPI utilized for their DMEPOS 
enrollment) when doing so. A commenter further requested that 
pharmacies enrolled as DMEPOS suppliers be permitted to have a single 
enrollment as a qualified home infusion therapy supplier; the commenter

[[Page 70347]]

believed this would enable pharmacies to submit all claims for items 
(for example, drugs and durable medical equipment) and services to the 
Part A/B MAC alone rather than to the DME MAC and the Part A/B MAC.
    Response: Similar to our response to a previous NPI-related 
comment, we encourage these commenters to review the NPI Final Rule, 
NPI regulations, and Medicare Expectations Subpart Paper for guidance 
concerning the acquisition and use of NPIs. We do note (and subject to 
the provisions of the NPI Final Rule, NPI regulations, and the Medicare 
Expectations Subpart Paper) that there is no express prohibition 
against using the same NPI for enrollment with the NSC as a DMEPOS 
supplier and enrollment with the Part A/B MAC as another provider or 
supplier type (such as a home infusion therapy supplier). On the other 
hand, this does not mean that such dually-enrolled providers and 
suppliers can use a single Form CMS-855 to encompass both their NSC 
enrollment and their Part A/B MAC enrollment. The Forms CMS-855S and 
CMS-855B are separate applications specifically tailored to capture 
certain information unique to the different provider and supplier types 
they pertain to; as an illustration, allowing an entity to enroll as a 
DMEPOS supplier via the Form CMS-855B (as opposed to the DMEPOS-
specific Form CMS-855S) would deprive the NSC of important data needed 
to verify the entity's compliance with all DMEPOS enrollment standards 
and requirements. Accordingly, we must respectfully decline the 
commenter's request for joint enrollment with the NSC and the Part A/B 
MAC via a single application.
5. Final Provisions
    After reviewing the comments received, we are finalizing our 
provisions pertaining to home infusion therapy supplier enrollment as 
proposed.

VI. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment before the provisions of a 
rule take effect in accordance with section 4 of the Administrative 
Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive this 
notice and comment procedure if the Secretary finds, for good cause, 
that the notice and comment process is impracticable, unnecessary, or 
contrary to the public interest, and incorporates a statement of the 
finding and the reasons therefore in the rule (5 U.S.C. 553(b)(B)). We 
amended Sec. Sec.  409.64(a)(2)(ii), 410.170(b), and 484.110 to include 
a provision requiring ``allowed practitioners'' to certify and 
establish home health services as a condition for payment under the 
home health benefit. These changes are simply additional regulation 
text changes that were inadvertently left out of the final regulations 
text changes in the first IFC (85 FR 27550) and do not reflect any 
substantive changes in policy. Additionally, this regulatory change was 
subject to notice and comment rulemaking following the issuance of the 
first IFC. Therefore, we find that undertaking further notice and 
comment procedures to incorporate these corrections into the CY 2021 
final rule is unnecessary and contrary to the public interest, as these 
regulation text changes are required by section 3708 of the CARES Act.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We solicited public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):

A. The Use of Telecommunications Technology Under the Medicare Home 
Health Benefit

    As discussed in III.F. of this final rule, we finalized the 
proposal to require that any provision of remote patient monitoring or 
other services furnished via a telecommunications system must be 
included on the plan of care and cannot substitute for a home visit 
ordered as part of the plan of care, and cannot be considered a home 
visit for the purposes of eligibility or payment. We will still require 
the use of such telecommunications technology to be tied to the 
patient-specific needs as identified in the comprehensive assessment, 
but we will not require a description of how such technology will help 
to achieve the goals outlined on the plan of care. We also stated that 
we expect to see documentation of how such services will be used to 
help achieve the goals outlined on the plan of care throughout the 
medical record when such technology is used. The expectation to see 
such documentation in the medical record does not create any additional 
burden for HHAs given that information describing how home health 
services help achieve established goals is traditionally documented in 
the clinical record. Likewise, documenting in the clinical record is a 
usual and customary practice as described in the supporting statement 
for the Paperwork Reduction Act Submission, Medicare and Medicaid 
Programs: Conditions of Participation for Home Health Agencies, OMB 
Control No. 0938-1299.

B. Enrollment

    This section discusses our proposed burden estimates for the 
enrollment of home infusion therapy suppliers as well as the PRA 
exemption we are claiming for the appeals process. As discussed in 
section V.B.3 of this final rule, home infusion therapy suppliers would 
be required to enroll in Medicare via the paper or internet-based 
version of the Form CMS-855B (``Medicare Enrollment Application: 
Clinics/Group Practices and Certain Other Suppliers'') (OMB Control 
Number: 0938-0685), or its electronic or successor application, and pay 
an application fee in accordance with Sec.  424.514.
    Using existing accreditation statistics and our internal data, we 
generally estimated that approximately: (1) 600 home infusion therapy 
suppliers would be eligible for Medicare enrollment under our 
provisions, all of whom would enroll in the initial year thereof; and 
(2) 50 home infusion therapy suppliers would annually enroll in Year 2 
and in Year 3. This results in a total of 700 home infusion therapy 
suppliers enrolling over the next 3 years.
    According to the most recent wage data provided by the Bureau of 
Labor Statistics (BLS) for May 2019 (see http://www.bls.gov/oes/current/oes_nat.htm), the mean hourly wages for the following 
categories are:

[[Page 70348]]

[GRAPHIC] [TIFF OMITTED] TR04NO20.017

    Consistent with Form CMS-855B projections made in recent rulemaking 
efforts, it would take each home infusion therapy supplier an average 
of 2.5 hours to obtain and furnish the information on the Form CMS-
855B. Per our experience, the home infusion therapy supplier's medical 
secretary would secure and report this data, a task that would take 
approximately 2 hours. Additionally, a health diagnosing and treating 
practitioner of the home infusion therapy supplier would review and 
sign the form, a process we estimate takes 30 minutes. Therefore, we 
projected a first-year burden of 1,500 hours (600 suppliers x 2.5 hrs) 
at a cost of $73,500 (600 suppliers x ((2 hrs x $36.62/hr) + (0.5 hrs x 
$98.52/hr)), a second-year burden of 125 hours (50 suppliers x 2.5 hrs) 
at a cost of $6,125 (50 suppliers x ((2 hrs x $36.62/hr) + (0.5 hrs x 
$98.52/hr)), and a third-year burden of 125 hours (50 suppliers x 2.5 
hrs) at a cost of $6,125 (50 suppliers x ((2 hrs x $36.62/hr) + (0.5 
hrs x $98.52/hr)). In aggregate, we estimated a burden of 1,750 hours 
(1,500 hrs + 125 hrs + 125 hrs) at a cost of $85,750. When averaged 
over the typical 3-year OMB approval period, we estimate an annual 
burden of 583 hours (1,750 hrs/3) at a cost of $28,583 ($85,750/3).
    We received no public comments on the foregoing burden estimates 
and are therefore finalizing them as proposed.

C. Appeals

    As mentioned previously in this final rule, proposed Sec.  
424.68(d)(2) and (e)(3) state that a home infusion therapy supplier may 
appeal, respectively, the denial or revocation of its enrollment 
application under 42 CFR part 498. While there are information 
collection requirements associated with the appeals process, we believe 
they are exempt from the PRA. In accordance with the implementing 
regulations of the PRA at 5 CFR 1320.4(a)(2), the information 
collection requirements associated with the appeals process are 
subsequent to an administrative action (specifically, the denial or 
revocation of a home infusion therapy supplier enrollment application). 
Therefore, we have not developed burden estimates. We also noted our 
belief that any costs associated with home infusion therapy supplier 
appeals would, in any event, be de minimis; this is because we would 
anticipate, based on past experience, there would be comparatively few 
denials and revocations of home infusion therapy supplier enrollments.
    We received no public comments on burden estimates related to the 
appeals provisions and are therefore finalizing them as proposed.

D. Submission of PRA-Related Comments

    We have submitted a copy of this final rule to OMB for its review 
of the rule's information collection requirements. The requirements are 
not effective until they have been approved by OMB.
    To obtain copies of the supporting statement and any related forms 
for the collections discussed in this rule, please visit the CMS 
website at www.cms.hhs.gov/PaperworkReductionActof1995, or call the 
Reports Clearance Office at (410) 786-1326.

VIII. Regulatory Impact Analysis

A. Statement of Need

1. Home Health Prospective Payment System (HH PPS)
    Section 1895(b)(1) of the Act requires the Secretary to establish a 
HH PPS for all costs of home health services paid under Medicare. In 
addition, section 1895(b) of the Act requires: (1) The computation of a 
standard prospective payment amount include all costs for home health 
services covered and paid for on a reasonable cost basis and that such 
amounts be initially based on the most recent audited cost report data 
available to the Secretary; (2) the prospective payment amount under 
the HH PPS to be an appropriate unit of service based on the number, 
type, and duration of visits provided within that unit; and (3) the 
standardized prospective payment amount be adjusted to account for the 
effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) 
of the Act addresses the annual update to the standard prospective 
payment amounts by the applicable home health percentage increase. 
Section 1895(b)(4) of the Act governs the payment computation. Sections 
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard 
prospective payment amount to be adjusted for case-mix and geographic 
differences in wage levels. Section 1895(b)(4)(B) of the Act requires 
the establishment of appropriate case-mix adjustment factors for 
significant variation in costs among different units of services. 
Lastly, section 1895(b)(4)(C) of the Act requires the establishment of 
wage adjustment factors that reflect the relative level of wages, and 
wage-related costs applicable to home health services furnished in a 
geographic area compared to the applicable national average level.
    Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with 
the authority to implement adjustments to the standard prospective 
payment amount (or amounts) for subsequent years to eliminate the 
effect of changes in aggregate payments during a previous year or years 
that were the result of changes in the coding or classification of 
different units of services that do not reflect real changes in case-
mix. Section 1895(b)(5) of the Act provides the Secretary with the 
option to make changes to the payment amount otherwise paid in the case 
of outliers because of unusual variations in the type or amount of 
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires 
HHAs to submit data for purposes of measuring health care quality, and 
links the quality data submission to the annual applicable percentage 
increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires 
the Secretary to implement a new methodology used to determine rural 
add-on payments for CYs 2019 through 2022.
    Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by 
section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, 
required the Secretary to implement a 30-day unit of service, for 30-
day periods beginning on and after January 1, 2020. The HH PPS wage 
index utilizes the wage adjustment factors used by the Secretary for 
purposes of Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act for 
hospital wage adjustments. In this final rule, we are adopting the new 
OMB delineations and applying a 5-percent cap only in CY 2021 on any 
decrease in a geographic

[[Page 70349]]

area's wage index value from the wage index value from the prior 
calendar year. This transition allows the effects of our adoption of 
the revised CBSA delineations to be phased in over 2 years, where the 
estimated reduction in a geographic area's wage index would be capped 
at 5 percent in CY 2021 (that is, no cap would be applied to the 
reduction in the wage index for the second year (CY 2022)).

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 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. 801(a)(1)(B)(i)), and Executive Order 13771 on 
Reducing Regulation and Controlling Regulatory Costs (January 30, 
2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. Given that, we note 
the following costs associated with the provisions of this final rule:
    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 2021 is estimated to be $390 million (1.9 percent). 
Therefore, we estimate that this rule is ``economically significant'' 
as measured by the $100 million threshold, and hence a major rule under 
the Congressional Review Act. Accordingly, we have prepared a 
Regulatory Impact Analysis that presents our best estimate of the costs 
and benefits of this rule.

C. Anticipated Effects

1. HH PPS
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, small entities 
include small businesses, nonprofit organizations, and small 
governmental jurisdictions. Most hospitals and most other providers and 
suppliers are small entities, either by nonprofit status or by having 
revenues of less than $7.5 million to $38.5 million in any one year. 
For the purposes of the RFA, we estimate that almost all HHAs and home 
infusion therapy suppliers are small entities as that term is used in 
the RFA. Individuals and states are not included in the definition of a 
small entity. The economic impact assessment is based on estimated 
Medicare payments (revenues) and HHS's practice in interpreting the RFA 
is to consider effects economically ``significant'' only if greater 
than 5 percent of providers reach a threshold of 3 to 5 percent or more 
of total revenue or total costs. The majority of HHAs' visits are 
Medicare paid visits and therefore the majority of HHAs' revenue 
consists of Medicare payments. Based on our analysis, we conclude that 
the policies in this final rule would not 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 not have a significant economic impact on a 
substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 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 that this final rule will not have a 
significant economic impact on the operations of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2020, that 
threshold is approximately $156 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 $156 million or more.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts State law, or otherwise has Federalism 
implications. We have reviewed this final rule under these criteria of 
Executive Order 13132, and have determined that it will not impose 
substantial direct costs on state or local governments.
2. HH QRP
    We did not propose any changes to the HH QRP. Therefore, we are not 
providing any estimated impacts.
3. Change to the CoP OASIS Requirement
    No impact was assessed for this provision in the January 13, 2017 
final rule titled ``Medicare and Medicaid Program: Conditions of 
Participation for Home Health Agencies (82 FR 4504). Therefore, we do 
not believe that there are any burden reductions to be assessed when 
removing this requirement.
4. Reporting Under the Home Health Value Based Purchasing (HHVBP) Model 
During the COVID-19 PHE
    Section IV.C of this rule finalizes a policy to align HHVBP Model 
data submission requirements with any exceptions or extensions granted 
for purposes of the HH QRP during the COVID-19 PHE, as well as a policy 
for granting exceptions to the New Measures data reporting requirements 
under the HHVBP Model during the COVID-19 PHE. We do not anticipate a 
change to Medicare expenditures as a result of this policy. The overall 
economic impact of the HHVBP Model for CYs 2018 through 2022 is an 
estimated $378 million in total savings to Medicare from a reduction in 
unnecessary hospitalizations and SNF usage as a result of greater 
quality

[[Page 70350]]

improvements in the HH industry. As for payments to HHAs, there are no 
aggregate increases or decreases expected to be applied to the HHAs 
competing in the model as a result of this policy.
5. Payment for Home Infusion Therapy Services
    In the CY 2020 HH PPS final rule with comment period, we estimated 
that the implementation of the permanent home infusion therapy benefit 
would result in a 3.6 percent decrease ($2 million) in payments to home 
infusion therapy suppliers in CY 2021 (84 FR 60639). This decrease 
reflects the exclusion of statutorily-excluded drugs and biologicals, 
and is representative of a wage-adjusted 4-hour payment rate, compared 
to a wage-adjusted 5-hour payment rate.
    There were no new proposals related to payments for home infusion 
therapy services in CY 202l. The CY 2021 final PFS amounts were not 
available at the time of rulemaking; however any impact to the CY 2021 
home infusion therapy payment amounts are be attributed to changes in 
the PFS amounts for 2021. The impact of updating the payment rates for 
home infusion therapy services for CY 2021, based on the proposed PFS 
amounts for CY 2021, is a 0.7 percent decrease ($384,800) in payments 
to eligible home infusion therapy suppliers in CY 2021.
6. Home Infusion Therapy Supplier Requirements
    As stated previously, we proposed that home infusion therapy 
suppliers be required to enroll in Medicare and pay an application fee 
at the time of enrollment in accordance with Sec.  424.514.
    The application fees for each of the past 3 calendar years were or 
are $569 (CY 2018), $586, (CY 2019), and $595 (CY 2020). Consistent 
with Sec.  424.514, the differing fee amounts are predicated on 
changes/increases in the Consumer Price Index (CPI) for all urban 
consumers (all items; United State city average, CPI-U) for the 12-
month period ending on June 30 of the previous year. Although we could 
not predict future changes to the CPI, the fee amounts between 2018 and 
2020 increased by an average of $13 per year. We believed this was a 
reasonable barometer with which to establish estimates (strictly for 
purposes of the final rule) of the fee amounts in the first 3 CYs of 
this rule (that is, 2021, 2022, and 2023). Thus, we projected a fee 
amount of $608 in 2021, $621 for 2022, and $634 for 2023.
    Applying these prospective fee amounts to the number of projected 
applicants in the rule's first 3 years, we estimated a total 
application fee cost to enrollees of $364,800 (or 600 x $608) in the 
first year, $31,050 (or 50 x $621) in the second year, and $31,700 (or 
50 x $634) in the third year. (This constituted an average annual 
figure of $142,517 over the first 3 years of this rulemaking). As 
referenced in Table 1 of this final rule, this would represent a 
transfer from home infusion therapy suppliers to the federal 
government. We received no comments concerning our projected 
application fee transfers and are therefore finalizing them as 
proposed.
    As noted in Table 1 and section VII.B. of this final rule, the 
estimated average annual burden associated with home infusion therapy 
supplier enrollment over the 3-year OMB approval period is 583 hours at 
a cost of $28,583.
7. Regulatory Review Cost Estimation
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule, we must 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that would review the rule, we assume that the total number of unique 
reviewers of this year's final rule would be the similar to the number 
of reviewers on this year's proposed rule. We acknowledge that this 
assumption may understate or overstate the costs of reviewing this 
rule. It is possible that not all commenters reviewed this year's rule 
in detail, and it is also possible that some reviewers chose not to 
comment on the proposed rule. For these reasons we believe that the 
number of past commenters would be a fair estimate of the number of 
reviewers of this rule. We also recognize that different types of 
entities are in many cases affected by mutually exclusive sections of 
this final rule, and therefore for the purposes of our estimate we 
assume that each reviewer reads approximately 50 percent of the rule. 
While we solicited comments on the approach in estimating the number of 
entities which would review the proposed rule and the assumption of how 
much of the rule reviewers would read, we did not receive any comments.
    Therefore, using the wage information from the BLS for medical and 
health service managers (Code 11-9111), we estimate that the cost of 
reviewing this rule is $110.74 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 1.80 hours for the staff to review half of 
this final rule, which consists of approximately 54,079 words. For each 
HHA that reviews the rule, the estimated cost is $199.33 (1.80 hours x 
$110.74). Therefore, we estimate that the total cost of reviewing this 
final rule is $32,291 ($199.33 x 162 reviewers). For purposes of this 
estimate, the number of reviewers of this year's rule is equivalent to 
the number of comments received for the CY 2021 HH PPS proposed rule.

D. Detailed Economic Analysis

    This rule finalizes updates to Medicare payments under the HH PPS 
for CY 2021. The impact analysis of this final rule presents the 
estimated expenditure effects of policy changes finalized in this rule. 
We use the latest data and best analysis available, but we do not make 
adjustments for future changes in such variables as number of visits or 
case mix. This analysis incorporates the latest estimates of growth in 
service use and payments under the Medicare home health benefit, based 
primarily on Medicare claims data for episodes ending on or before 
December 31, 2019. We note that certain events may combine to limit the 
scope or accuracy of our impact analysis, because such an analysis is 
future-oriented and, thus, susceptible to errors resulting from other 
changes in the impact time period assessed. Some examples of such 
possible events are newly-legislated general Medicare program funding 
changes made by the Congress, or changes specifically related to HHAs. 
In addition, changes to the Medicare program may continue to be made as 
a result of the Affordable Care Act, or new statutory provisions. 
Although these changes may not be specific to the HH PPS, the nature of 
the Medicare program is such that the changes may interact, and the 
complexity of the interaction of these changes could make it difficult 
to predict accurately the full scope of the impact upon HHAs.
    Table 18 represents how HHA revenues are likely to be affected by 
the policy changes in this final rule for CY 2021. For this analysis, 
we used an analytic file with linked CY 2019 OASIS assessments and home 
health claims data for dates of service that ended on or before 
December 31, 2019. The first column of Table 18 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 updating to the CY 2021 wage index. The 
fourth column shows the effects of

[[Page 70351]]

moving from the old OMB delineations to the new OMB delineations with a 
5 percent cap on wage index decreases. The fifth column shows the 
payment effects of the CY 2021 rural add-on payment provision in 
statute. The sixth column shows the payment effects of the CY 2021 home 
health payment update percentage and the last column shows the combined 
effects of all the policies finalized in this rule.
    Overall, it is projected that aggregate payments in CY 2021 would 
increase by 1.9 percent. As illustrated in Table 18, 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 2021 wage index, the percentage of 
total HH PPS payments that were subject to the low-utilization payment 
adjustment (LUPA) or paid as outlier payments, and the degree of 
Medicare utilization.
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E. Alternatives Considered

    For the CY 2021 HH PPS proposed rule, we considered alternatives to 
the proposals articulated in section III.B. of this final rule. We 
considered not adopting the OMB delineations. However, we have 
historically adopted the latest OMB delineations as we believe that 
implementing the new OMB delineations would result in wage index values 
being more representative of the actual costs of labor in a given area. 
Additionally, we considered not implementing the 1-year 5-percent cap 
on wage index decreases. While there are some minimal impacts on 
certain HHAs as a result of this 5-percent cap as shown in the 
regulatory impact analysis of this final rule, we decided that the 5-
percent cap was a better option for the transition because it would 
mitigate potential negative impacts from the transition to the new OMB 
delineations and allow providers the opportunity to adjust to the 
changes in their wage index values gradually.

F. Accounting Statement and Tables

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 19, we have prepared an accounting statement showing 
the classification of the transfers and benefits associated with the CY 
2021 HH PPS provisions of this rule.
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[[Page 70354]]



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. It 
has been determined that this final rule is an action that primarily 
results in transfers and does not impose more than de minimis costs as 
described previously and thus is not a regulatory or deregulatory 
action for the purposes of Executive Order 13771.

H. Conclusion

    In conclusion, we estimate that the provisions in this final rule 
would result in an estimated net increase in HH payments of 1.9 percent 
for CY 2021 ($390 million). The $390 million increase in estimated 
payments for CY 2021 reflects the effects of the CY 2021 home health 
payment update percentage of 2.0 percent ($410 million increase) and an 
estimated -0.1 percent decrease in payments due to the rural add-on 
percentages mandated by the Bipartisan Budget Act of 2018 for CY 2021 
($20 million decrease).

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Rural areas, X-rays

42 CFR Part 414

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

42 CFR Part 424

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

42 CFR Part 484

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

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

PART 409--HOSPITAL INSURANCE BENEFITS

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

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

0
2. Section 409.43 is amended by revising paragraphs (a) introductory 
text, (a)(1), and (3) to read as follows:


Sec.  409.43   Plan of care requirements.

    (a) Contents. An individualized plan of care must be established 
and periodically reviewed by the certifying physician or allowed 
practitioner.
    (1) The HHA must be acting upon a plan of care that meets the 
requirements of this section for HHA services to be covered.
* * * * *
    (3)(i) The plan of care must include all of the following:
    (A) The identification of the responsible discipline(s) and the 
frequency and duration of all visits as well as those items listed in 
Sec.  484.60(a) of this chapter that establish the need for such 
services.
    (B) Any provision of remote patient monitoring or other services 
furnished via telecommunications technology (as defined in Sec.  
409.46(e)) or audio-only technology. Such services must be tied to the 
patient-specific needs as identified in the comprehensive assessment, 
cannot substitute for a home visit ordered as part of the plan of care, 
and cannot be considered a home visit for the purposes of patient 
eligibility or payment.
    (ii) All care provided must be in accordance with the plan of care.
* * * * *

0
3. Section 409.46 is amended by revising paragraph (e) to read as 
follows:


Sec.  409.46   Allowable administrative costs.

* * * * *
    (e) Telecommunications technology. Telecommunications technology, 
as indicated on the plan of care, can include: remote patient 
monitoring, defined 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; teletypewriter (TTY); and 2-way audio-video telecommunications 
technology that allows for real-time interaction between the patient 
and clinician. The costs of any equipment, set-up, and service related 
to the technology 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 technology, without the provision of a 
skilled service, are not separately billable.

0
4. Section 409.49 is amended by adding paragraph (h) to read as 
follows:


Sec.  409.49   Excluded services.

* * * * *
    (h) Services covered under the home infusion therapy benefit. 
Services that are covered under the home infusion therapy benefit as 
outlined at Sec.  486.525 of this chapter, including any home infusion 
therapy services furnished to a Medicare beneficiary that is under a 
home health plan of care, are excluded from coverage under the Medicare 
home health benefit. Excluded home infusion therapy services pertain to 
the items and services for the provision of home infusion drugs, as 
defined at Sec.  486.505 of this chapter. Services for the provision of 
drugs and biologicals not covered under this definition may continue to 
be provided under the Medicare home health benefit.

0
5. Section 409.64 is amended by revising paragraph (a)(2)(ii) to read 
as follows:


Sec.  409.64   Services that are counted toward allowable amounts.

* * * * *
    (a) * * *
    (2) * * *
    (ii) The hospital, CAH, SNF, or home health agency had submitted 
all necessary evidence, including physician or allowed practitioner 
certification of need for services when such certification was 
required;
* * * * *

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
6. The authority citation for part 410 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0
7. Section 410.170 is amended by revising paragraph (b) to read as 
follows:


Sec.  410.170   Payment for home health services, for medical and other 
health services furnished by a provider or an approved ESRD facility, 
and for comprehensive outpatient rehabilitation facility (CORF) 
services: Conditions.

* * * * *
    (b) Physician or allowed practitioner certification. For home 
health services, a physician or allowed practitioner provides 
certification and recertification in accordance with Sec.  424.22 of 
this chapter.
* * * * *

[[Page 70355]]

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

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

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0
9. Section 414.1505 is amended by adding paragraph (c) to read as 
follows:


Sec.  414.1505   Requirement for payment.

* * * * *
    (c) The home infusion therapy supplier must be enrolled in Medicare 
consistent with the provisions of Sec.  424.68 and part 424, subpart P 
of this chapter.

PART 424--CONDITIONS FOR MEDICARE PAYMENT

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

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

0
11. Section 424.68 is added to subpart E to read as follows:


Sec.  424.68   Enrollment requirements for home infusion therapy 
suppliers.

    (a) Definition. For purposes of this section, a home infusion 
therapy supplier means a supplier of home infusion therapy that meets 
all of the following requirements:
    (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) Is enrolled in Medicare as a home infusion therapy supplier 
consistent with the provisions of this section and subpart P of this 
part.
    (b) General requirement. For a supplier to receive Medicare payment 
for the provision of home infusion therapy supplier services, the 
supplier must qualify as a home infusion therapy supplier (as defined 
in this section) and be in compliance with all applicable provisions of 
this section and of subpart P of this part.
    (c) Specific requirements for enrollment. To enroll in the Medicare 
program as a home infusion therapy supplier, a home infusion therapy 
supplier must meet all of the following requirements:
    (1)(i) Fully complete and submit the Form CMS-855B application (or 
its electronic or successor application) to its applicable Medicare 
contractor.
    (ii) Certify via the Form CMS-855B that the home infusion therapy 
supplier meets and will continue to meet the specific requirements and 
standards for enrollment described in this section and in subpart P of 
this part.
    (2) Comply with the application fee requirements in Sec.  424.514.
    (3) Be currently and validly accredited as a home infusion therapy 
supplier by a CMS-recognized home infusion therapy supplier 
accreditation organization.
    (4) Comply with Sec.  414.1515 of this chapter and all provisions 
of part 486, subpart I of this chapter.
    (5) Successfully complete the limited categorical risk level of 
screening under Sec.  424.518.
    (d) Denial of enrollment. (1) Enrollment denial by CMS. CMS may 
deny a supplier's enrollment application as a home infusion therapy 
supplier on either of the following grounds:
    (i) The supplier does not meet all of the requirements for 
enrollment outlined in Sec.  424.68 and in subpart P of this part.
    (ii) Any of the applicable denial reasons in Sec.  424.530.
    (2) Appeal of an enrollment denial. A supplier may appeal the 
denial of its enrollment application as a home infusion therapy 
supplier under part 498 of this chapter.
    (e) Continued compliance, standards, and reasons for revocation. 
(1) Upon and after enrollment, a home infusion therapy supplier--
    (i) Must remain currently and validly accredited as described in 
paragraph (c)(3) of this section.
    (ii) Remains subject to, and must remain in full compliance with, 
all of the provisions of--
    (A) This section;
    (B) Subpart P of this part;
    (C) Section 414.1515 of this chapter; and
    (D) Part 486, subpart I of this chapter.
    (2) CMS may revoke a home infusion therapy supplier's enrollment on 
any of the following grounds:
    (i) The supplier does not meet the accreditation requirements as 
described in paragraph (c)(3) of this section.
    (ii) The supplier does not comply with all of the provisions of--
    (A) This section;
    (B) Subpart P of this part;
    (C) Section 414.1515 of this chapter; and
    (D) Part 486, subpart I of this chapter; or
    (iii) Any of the revocation reasons in Sec.  424.535 applies.
    (3) A home infusion therapy supplier may appeal the revocation of 
its enrollment under part 498 of this chapter.

0
12. Section 424.518 is amended by redesignating paragraphs (a)(1)(vii) 
through (xvi) as paragraphs (a)(1)(viii) through (xvii) and adding a 
new paragraph (a)(1)(vii) to read as follows:


Sec.  424.518   Screening levels for Medicare providers and suppliers.

* * * * *
    (a) * * *
    (1) * * *
    (vii) Home infusion therapy suppliers.
* * * * *

0
13. Section 424.520 is amended by revising paragraph (d) introductory 
text to read as follows:


Sec.  424.520   Effective date of Medicare billing privileges.

* * * * *
    (d) Physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, opioid 
treatment programs, and home infusion therapy suppliers. The effective 
date for billing privileges for physicians, non-physician 
practitioners, physician and non-physician practitioner organizations, 
ambulance suppliers, opioid treatment programs, and home infusion 
therapy suppliers is the later of--
* * * * *

0
14. Section 424.521 is amended by revising the section heading and 
paragraph (a) introductory text to read as follows:


Sec.  424.521   Request for payment by physicians, non-physician 
practitioners, physician and non-physician organizations, ambulance 
suppliers, opioid treatment programs, and home infusion therapy 
suppliers.

    (a) Physicians, non-physician practitioners, physician and non-
physician practitioner organizations, ambulance suppliers, opioid 
treatment programs, and home infusion therapy suppliers may 
retrospectively bill for services when the physician, non-physician 
practitioner, physician or non-physician organization, ambulance 
supplier, opioid treatment program, or home infusion therapy supplier 
has met all program requirements, including State licensure 
requirements, and services were provided at the enrolled practice 
location for up to--
* * * * *

PART 484--HOME HEALTH SERVICES

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


[[Page 70356]]


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


Sec.  484.45   [Amended]

0
16. Section 484.45 is amended by--
0
a. Removing paragraph (c)(2); and
0
b. Redesignating paragraphs (c)(3) and (4) as paragraphs (c)(2) and 
(3), respectively.

0
17. Section 484.110 is amended by revising the introductory text and 
paragraph (a)(1) to read as follows:


Sec.  484.110   Condition of participation: Clinical records.

    The HHA must maintain a clinical record containing past and current 
information for every patient accepted by the HHA and receiving home 
health services. Information contained in the clinical record must be 
accurate, adhere to current clinical record documentation standards of 
practice, and be available to the physician(s) or allowed 
practitioner(s) issuing orders for the home health plan of care, and 
appropriate HHA staff. This information may be maintained 
electronically.
    (a) * * *
    (1) The patient's current comprehensive assessment, including all 
of the assessments from the most recent home health admission, clinical 
notes, plans of care, and physician or allowed practitioner orders;
* * * * *

    Dated: October 23, 2020.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.

    Dated: October 26, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-24146 Filed 10-29-20; 4:15 pm]
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