[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Proposed Rules]
[Pages 39408-39453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13792]



[[Page 39407]]

Vol. 85

Tuesday,

No. 126

June 30, 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, 414, 424, et al.





Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment 
System Rate Update; Home Health Quality Reporting Requirements; and 
Home Infusion Therapy Services Requirements; Proposed Rule

  Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / 
Proposed Rules  

[[Page 39408]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 414, 424, and 484

[CMS-1730-P]
RIN 0938-AU-06


Medicare and Medicaid Programs; CY 2021 Home Health Prospective 
Payment System Rate Update; Home Health Quality Reporting Requirements; 
and Home Infusion Therapy Services Requirements

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would update the home health prospective 
payment system (HH PPS) payment rates and wage index for calendar year 
(CY) 2021. This proposed rule also proposes to make permanent the 
changes to the home health regulations regarding the use of technology 
in providing services under the Medicare home health benefit as 
described in the Medicare and Medicaid Programs; Revisions in Response 
to the COVID-19 Public Health Emergency interim final rule with comment 
period. This proposed rule also proposes to remove 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. This 
proposed rule discusses policies finalized in the CY 2020 HH PPS final 
rule with comment period regarding the permanent home infusion therapy 
services benefit for CY 2021, and proposes conforming regulations text 
changes excluding home infusion therapy services from coverage under 
the Medicare home health benefit. Additionally, this proposed rule 
discusses Medicare enrollment policies for qualified home infusion 
therapy suppliers.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 31, 2020.

ADDRESSES: In commenting, please refer to file code CMS-1730-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1730-P, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1730-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Hillary Loeffler, (410) 786-0456, 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.
    Joseph Schultz, 410-786-2656, for information about home infusion 
therapy supplier enrollment requirements.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that website to view public comments.

I. Executive Summary

A. Purpose

1. Home Health Prospective Payment System (HH PPS)
    This proposed rule would update the payment rates for home health 
agencies (HHAs) for calendar year (CY) 2021, as required under section 
1895(b) of the Social Security Act (the Act). This proposed rule would 
also set 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; and 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). 
This rule also proposes to adopt the revised 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 also proposes a 
cap on wage index decreases in excess of 5 percent. This proposed rule 
would adopt the new 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. 
Finally, this proposed rule proposes to permanently finalize the 
changes to Sec.  409.43(a) as finalized in ``Medicare and Medicaid 
Programs; Policy and Regulatory Revisions in Response to the COVID-19 
Public Health Emergency'' interim final rule with comment period (First 
COVID-19 PHE IFC) (85 FR 19230), to state that the plan of care must 
include any provision of remote patient monitoring or other services 
furnished via a telecommunications system.
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    \1\ On March 6, 2020, OMB issued the most recent OMB Bulletin 
No. 20-01. Bulletin No. 20-01 was not utilized for this proposed 
rulemaking.
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2. Home Health Quality Reporting Program (HH QRP)
    We are not proposing any changes for the Home Health Quality 
Reporting Program.
3. Changes to the CoP OASIS Requirements
    This proposed rule would remove 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. Home Infusion Therapy Services
    This proposed rule outlines the home infusion therapy policies 
finalized in

[[Page 39409]]

the CY 2020 HH PPS final rule with comment period (84 FR 60615), as 
required by section 1834(u) of the Act. This proposed rule includes 
conforming regulations text changes excluding home infusion therapy 
services from coverage under the Medicare home health benefit as 
required by the conforming amendment in section 5012(c)(3) of the 21st 
Century Cures Act.
5. Enrollment Standards for Qualified Home Infusion Therapy Suppliers
    This proposed rule would set out the Medicare provider enrollment 
policies for qualified home infusion therapy suppliers.

B. Summary of the Provisions of This Rule

1. Home Health Prospective Payment System (HH PPS)
    In section III.A of this rule, we propose to 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 PDGM. The PDGM is our new case-mix adjustment methodology to adjust 
payments for home health periods of care beginning on and after January 
1, 2020. The PDGM relies more heavily on clinical characteristics and 
other patient information to place patients into meaningful payment 
categories and eliminates the use of therapy service thresholds, as 
required by section 1895(b)(4)(B) of the Act, as amended by section 
51001(a)(3) of the Bipartisan Budget Act of 2018 (BBA of 2018).
    Section III.B. of this rule proposes to adopt the OMB statistical 
area delineations outlined in a September 14, 2018, OMB bulletin No. 
18-04. This rule also proposes a transition with a 1-year cap on wage 
index decreases in excess of 5 percent, consistent with the policy 
being proposed for other Medicare payment systems. This proposed rule 
would adopt the new 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 propose to 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 estimated to be 2.7 percent. 
Additionally, for CY 2021, this proposed rule proposes to maintain the 
fixed-dollar loss ratio at 0.63, as finalized for CY 2020.
    Section III.D. of this proposed rule proposes to permanently 
finalize the changes to Sec.  409.43(a) as finalized in the first 
COVID-19 PHE IFC (85 FR 19230), to state that the plan of care must 
include any provision of remote patient monitoring or other services 
furnished via a telecommunications system and 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.
    Section IV. of this proposed rule discusses the HH QRP and proposed 
changes to the conditions of participation (CoP) OASIS requirements.
    In sections V.A.1. and 2. of this proposed 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 HH PPS 
final rule with comment period for the CY 2021 implementation (84 FR 
60628). In section V.A.5. of this proposed rule, we propose 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 proposed rule, we discuss proposed 
requirements regarding enrollment standards for qualified home infusion 
therapy suppliers.

C. Summary of Costs, Transfers, and Benefits

[[Page 39410]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.088

III. Home Health Prospective Payment System

A. Overview of the Home Health Prospective Payment System

1. Statutory Background
    The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted 
August 5, 1997), significantly changed the way Medicare pays for 
Medicare home health services. Section 4603 of the BBA mandated the 
development of the HH PPS. Until the implementation of the HH PPS on 
October 1, 2000, HHAs received payment under a retrospective 
reimbursement system. Section 4603(a) of the BBA mandated the 
development of a HH PPS for all Medicare-covered home health services 
provided under a plan of care (POC) that were paid on a reasonable cost 
basis by adding section 1895 of the Act, entitled ``Prospective Payment 
For Home Health Services.'' Section 1895(b)(1) of the Act requires the 
Secretary to establish a HH PPS for all costs of home health services 
paid under Medicare. Section 1895(b)(2) of the Act required that, in 
defining a prospective payment amount, the Secretary will consider an 
appropriate unit of service and the number, type, and duration of 
visits provided within that unit, potential changes in the mix of 
services provided within that unit and their cost, and a general system 
design that provides for continued access to quality services.
    Section 1895(b)(3)(A) of the Act required the following: (1) The 
computation of a standard prospective payment amount that includes all 
costs for HH services covered and paid for on a reasonable cost basis, 
and that such amounts be initially based on the most recent audited 
cost report data available to the Secretary (as of the effective date 
of the 2000 final rule); and (2) the standardized prospective payment 
amount be adjusted to account for the effects of case-mix and wage 
levels among HHAs. Section 1895(b)(3)(B) of the Act requires the 
standard prospective payment amounts be annually updated by the home 
health applicable percentage increase. Section 1895(b)(4) of the Act 
governs the payment computation. Sections 1895(b)(4)(A)(i) and 
(b)(4)(A)(ii) of the Act require the standard prospective payment 
amount 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

[[Page 39411]]

Register (65 FR 41128) to implement the HH PPS legislation. The July 
2000 final rule established requirements for the new HH PPS for home 
health services as required by section 4603 of the BBA, as subsequently 
amended by section 5101 of the Omnibus Consolidated and Emergency 
Supplemental Appropriations Act for Fiscal Year 1999 (OCESAA), (Pub. L. 
105-277, enacted October 21, 1998); and by sections 302, 305, and 306 
of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 
1999, (BBRA) (Pub. L. 106-113, enacted November 29, 1999). The 
requirements include the implementation of a HH PPS for home health 
services, consolidated billing requirements, and a number of other 
related changes. The HH PPS described in that rule replaced the 
retrospective reasonable cost-based system that was used by Medicare 
for the payment of home health services under Part A and Part B. For a 
complete and full description of the HH PPS as required by the BBA, see 
the July 2000 HH PPS final rule (65 FR 41128 through 41214).
    Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) 
to the Act, requiring HHAs to submit data for purposes of measuring 
health care quality, and linking the quality data submission to the 
annual applicable payment percentage increase. This data submission 
requirement is applicable for CY 2007 and each subsequent year. If an 
HHA does not submit quality data, the home health market basket 
percentage increase is reduced by 2 percentage points. In the November 
9, 2006 Federal Register (71 FR 65935), we published a final rule to 
implement the pay-for-reporting requirement of the DRA, which was 
codified at Sec.  484.225(h) and (i) in accordance with the statute. 
The pay-for-reporting requirement was implemented on January 1, 2007.
    The Affordable Care Act made additional changes to the HH PPS. One 
of the changes in section 3131 of the Affordable Care Act is the 
amendment to section 421(a) of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, 
enacted on December 8, 2003) as amended by section 5201(b) of the DRA. 
Section 421(a) of the MMA, as amended by section 3131 of the Affordable 
Care Act, requires that the Secretary increase, by 3 percent, the 
payment amount otherwise made under section 1895 of the Act, for HH 
services furnished in a rural area (as defined in section 1886(d)(2)(D) 
of the Act) with respect to episodes and visits ending on or after 
April 1, 2010, and before January 1, 2016. Section 210 of the Medicare 
Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA) 
amended section 421(a) of the MMA to extend the 3 percent rural add-on 
payment for home health services provided in a rural area (as defined 
in section 1886(d)(2)(D) of the Act) through January 1, 2018. In 
addition, section 411(d) of MACRA amended section 1895(b)(3)(B) of the 
Act such that CY 2018 home health payments be updated by a 1 percent 
market basket increase. Section 50208(a)(1) of the BBA of 2018 again 
extended the 3 percent rural add-on through the end of 2018. In 
addition, this section of the BBA of 2018 made some important changes 
to the rural add-on for CYs 2019 through 2022.
    Section 51001(a)(1)(B) of the Bipartisan Budget Act of 2018 (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 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.
2. Current System for Payment of Home Health Services Beginning in CY 
2020 and Subsequent Year
    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,

[[Page 39412]]

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 better ensure 
that clinically complex and ill beneficiaries have adequate access to 
home health care, in the CY 2019 HH PPS final rule with comment period 
(83 FR 56406), we finalized case-mix methodology refinements through 
the 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 which 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 each 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 
proposed 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.
[GRAPHIC] [TIFF OMITTED] TP30JN20.089


[[Page 39413]]


a. 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 be considered early unless there is a 
gap of more than 60 days between the end of one period of care and the 
start of another. Information regarding the timing of a 30-day period 
of care 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.''
b. 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 
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 HH claim to the appropriate institutional category. 
Similarly, when the Medicare claims processing system receives a 
Medicare acute or post-acute care claim for an institutional stay, the 
systems will check for the presence of a HH claim with a community 
admission source payment group. If such HH claim is found, and the 
institutional stay occurred within 14 days prior to the home health 
admission, our systems trigger an automatic adjustment of the HH claim 
to the appropriate institutional category. This process may occur any 
time within the 12-month timely filing period for the acute or post-
acute claim. For purposes of a Request for Anticipated Payment (RAP), 
only the final claim will be adjusted to reflect the admission source. 
More information regarding the admission source reporting requirements 
for RAP and claims submission, 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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c. Clinical Groupings
    Each 30-day period of care is grouped into one of 12 clinical 
groups which describe the primary reason for which patients are 
receiving home health services under the Medicare home health benefit. 
The clinical grouping is based on the principal diagnosis reported on 
home health claims. The 12 clinical groups are listed and described in 
Table 2.

[[Page 39414]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.090

    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 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.
d. 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 60478, 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'' 
posted on the 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

[[Page 39415]]

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

e. Comorbidity Adjustment
    Thirty-day periods will receive a comorbidity adjustment category 
based on the presence of certain secondary diagnoses reported on home 
health claims. These diagnoses are based on a home-health specific list 
of clinically and statistically significant secondary diagnosis 
subgroups with similar resource use, meaning the secondary diagnoses 
have at least as high as the median resource use and represent more 
that 0.1 percent of 30-day periods of care. Home health 30-day periods 
of care can receive a comorbidity adjustment under the following 
circumstances:
     Low comorbidity adjustment: There is a reported 
secondary diagnosis on the home health-specific comorbidity subgroup 
list that is associated with higher resource use.
     High comorbidity adjustment: There are two or 
more secondary diagnoses on the home health-specific comorbidity 
subgroup interaction list that are associated with higher resource use 
when both are reported together compared to if they were reported 
separately. That is, the two diagnoses may interact with one another, 
resulting in higher resource use.
     No comorbidity adjustment: A 30-day period of 
care will receive no comorbidity adjustment if no secondary diagnoses 
exist or none meet the criteria for a low or high comorbidity 
adjustment. 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.

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

1. CY 2021 PDGM Low-Utilization Payment Adjustment (LUPA) Thresholds 
and PDGM Case-Mix Weights
a. Proposed 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 (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 proposed 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 of 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 to reflect only minor changes. 
Therefore, we are proposing to maintain the LUPA thresholds 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 these 
LUPA thresholds (along with the case-mix weights) that will be used for 
CY 2021 on the HHA Center and PDGM web pages.
b. 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) 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 
are proposing 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 proposed 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 will be less burdensome for HHAs and 
software vendors, who continue to familiarize themselves with this new 
case-mix methodology.
2. Proposed Home Health Wage Index Changes
a. Proposed 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

[[Page 39416]]

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. As 
discussed below, this bulletin was not available in time for the 
development of this proposed rule. 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 are proposing 
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 this 
proposed rule. We will include any updates from OMB Bulletin No. 20-01 
in any changes that would be adopted in the CY 2022 HH PPS proposed 
rule.
(1) 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 are proposing to 
continue to treat Micropolitan Areas as ``rural'' and to include 
Micropolitan Areas in the calculation of each state's rural wage index.
(2) Urban Counties Becoming Rural
    If we adopt the new OMB delineations (based upon the 2010 decennial 
Census data), a total of 34 counties (and county equivalents) that are 
currently considered urban would be considered rural beginning in CY 
2021. Table 3 lists the 34 counties that would change to rural status 
if we finalize our proposal to implement the new OMB delineations.
BILLING CODE 4120-01-P

[[Page 39417]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.091

(3) Rural Counties Becoming Urban
    If we finalize our proposal to implement the new OMB delineations 
(based upon the 2010 decennial Census data), a total of 47 counties 
(and county equivalents) that are currently designated rural would be 
considered urban beginning in CY 2021. Table 4 lists the 47 counties 
that would change to urban status.

[[Page 39418]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.092


[[Page 39419]]


(4) Urban Counties Moving to a Different Urban CBSA
    In addition to rural counties becoming urban and urban counties 
becoming rural, several urban counties would shift from one urban CBSA 
to another urban CBSA under our proposal to adopt the new OMB 
delineations (Table 5). In other cases, applying the new OMB 
delineations would involve a change only in CBSA name or number, while 
the CBSA continues to encompass the same constituent counties. For 
example, CBSA 19380 (Dayton, OH) would experience both a change to its 
number and its name, and become CBSA 19430 (Dayton-Kettering, OH), 
while all of its three constituent counties would remain the same. In 
other cases, only the name of the CBSA would be modified, and none of 
the currently assigned counties would be reassigned to a different 
urban CBSA. We are not discussing these proposed changes in this 
section because they are inconsequential changes with respect to the 
home health wage index.
[GRAPHIC] [TIFF OMITTED] TP30JN20.093

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

[[Page 39420]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.094

BILLING CODE 4120-01-C
b. Proposed Transition Period
    As discussed above, overall, we believe that our proposal to adopt 
the revised OMB delineations for CY 2021 would result 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 our proposal.
    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 are proposing 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 are proposing 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 would allow the effects of our proposed 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, would 
be 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 proposed 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

[[Page 39421]]

adoption of the new OMB delineations. We believe a one year 5 percent 
cap provides home health agencies sufficient time to plan appropriately 
for CY 2022 and future years. Because we believe that using the new OMB 
delineations would create a more accurate payment adjustment for 
differences in area wage levels we are proposing 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 
this 5 percent cap proposal as shown in the regulatory impact analysis 
of this proposed rule, overall, the impact between the CY 2021 wage 
index using the old OMB delineations and the proposed 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 
invite comments on our proposed transition methodology.
    The proposed 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 proposed HH PPS wage index for CY 2021 would be 
effective January 1, 2021 through December 31, 2021.
    The wage index file posted on the CMS website provides a crosswalk 
between the CY 2021 wage index using the current OMB delineations and 
the CY 2021 wage index using the proposed revised OMB delineations, as 
well as the proposed transition wage index values that would be in 
effect in CY 2021 if these proposed changes are finalized. It also 
shows each state and county and its corresponding proposed transition 
wage index along with the previous CBSA number, the new CBSA number or 
alternate identification number, and the new CBSA name.
3. Proposed CY 2021 Home Health Payment Rate Updates
a. Proposed 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 rebasing 
of the home health market basket to reflect 2016 Medicare cost report 
(MCR) data, the latest available and complete data on the actual 
structure of HHA costs. As such, based on the rebased 2016-based home 
health market basket, we finalized that the labor-related share is 76.1 
percent and the non-labor-related share is 23.9 percent. A detailed 
description of how we rebased the HHA market basket is available in the 
CY 2019 HH PPS final rule with comment period (83 FR 56425 through 
56436).
    Section 1895(b)(3)(B) of the Act requires that in CY 2015 and in 
subsequent calendar years, except CY 2018 (under section 411(c) of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 
114-10, enacted April 16, 2015)), and 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.
    The proposed home health update percentage for CY 2021 is based on 
the estimated home health market basket update, specified at section 
1895(b)(3)(B)(iii) of the Act, of 3.1 percent (based on IHS Global 
Insight Inc.'s first-quarter 2020 forecast with historical data through 
fourth-quarter 2019). The estimated CY 2021 home health market basket 
update of 3.1 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), currently estimated to be 
0.4 percentage point for CY 2021. In effect, the proposed home health 
payment update percentage for CY 2021 is a 2.7 percent increase. 
Section 1895(b)(3)(B)(v) of the Act requires that the home health 
update be decreased by 2 percentage points for those HHAs that do not 
submit quality data as required by the Secretary. For HHAs that do not 
submit the required quality data for CY 2021, the home health payment 
update would be 0.7 percent (2.7 percent minus 2 percentage points). If 
more recent data becomes available after the publication of this 
proposed rule and before the publication of the final rule (for 
example, more recent estimates of the home health market basket update 
and MFP adjustment), we would use such data, if appropriate, to 
determine the home health payment update percentage for CY 2021 in the 
final rule.
b. 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 HH services. Since 
the inception of the HH PPS, we have used inpatient hospital wage data 
in developing a wage index to be applied to HH payments. We propose to 
continue this practice for CY 2021, as we continue to believe that, in 
the absence of HH-specific wage data that accounts for area 
differences, using inpatient hospital wage data is appropriate and 
reasonable for the HH PPS. As discussed above, we propose 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 propose to continue to 
use the same methodology discussed in the CY 2007 HH PPS final rule (71 
FR 65884) to address those geographic areas in which there are no 
inpatient hospitals. For rural areas that do not have inpatient 
hospitals, we propose to use the average wage index from all contiguous 
Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently, 
the only 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

[[Page 39422]]

example, due to the close proximity to one another of almost all of 
Puerto Rico's various urban and non-urban areas, this methodology would 
produce a wage index for rural Puerto Rico that is higher than that in 
half of its urban areas). Instead, we propose to continue to use the 
most recent wage index previously available for that area. 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 adjusted, new delineations wage index value for Hinesville, GA is 
0.8478.
    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 0.8586. Bulletin No. 17-01 
is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.\4\
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    \4\ ``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/wp-content/uploads/2020/03/Bulletin-20-01.pdf.
    The proposed CY 2021 wage index is available on the CMS website at: 
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
c. CY 2021 Annual Payment Update
(1) 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 
Medicare cost report (MCR) data, the latest available and most complete 
data on the actual structure of HHA costs. We also finalized a revision 
to the labor-related share to reflect the 2016-based home health market 
basket compensation (Wages and Salaries plus Benefits) cost weight. We 
finalized that for CY 2019 and subsequent years, the labor-related 
share would be 76.1 percent and the non-labor-related share would be 
23.9 percent. The following are the steps we take to compute the case-
mix and wage-adjusted 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 sets forth the 
specific annual percentage update methodology. In accordance with 
section 1895(b)(3)(B)(v) of the Act and Sec.  484.225(i), for an HHA 
that does not submit HH quality data, as specified by the Secretary, 
the unadjusted national prospective 30-day period rate is equal to the 
rate for the previous calendar year increased by the applicable HH 
payment update, minus 2 percentage points. Any reduction of the 
percentage change would apply only to the calendar year involved and 
would not be considered in computing the prospective payment amount for 
a subsequent calendar year.
    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.
(2) 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. While we continue 
to monitor the impact of these changes on patient outcomes and Medicare 
expenditures, we believe 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 current public health emergency 
resulting from the COVID-19 pandemic outbreak. Therefore, for CY 2021, 
we are not proposing to make any additional

[[Page 39423]]

changes to the national, standardized 30-day payment rate in this 
proposed rule other than the routine rate updates outlined below. In 
future rulemaking, we plan to determine whether any changes need to be 
made to the national, standardized 30-day 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 proposed rule.
    To calculate the wage index budget neutrality factor, we simulated 
total payments for non-LUPA 30-day periods using the proposed 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 0.9987. We 
would apply the wage index budget neutrality factor of 0.9987 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 are not 
proposing 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 would update the 30-day payment rate by the CY 2021 home 
health payment update percentage of 2.7 percent. The CY 2021 national, 
standardized 30-day period payment rate is calculated in Table 7.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP30JN20.095

    The CY 2021 national, standardized 30-day episode payment rate for 
an HHA that does not submit the required quality data is updated by the 
CY 2021 home health payment update of 2.7 percent minus 2 percentage 
points and is shown in Table 8.
[GRAPHIC] [TIFF OMITTED] TP30JN20.096

(3) 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 HH discipline. The six HH 
disciplines are as follows:
     Home health aide (HH aide).
     Medical Social Services (MSS).
     Occupational therapy (OT).
     Physical therapy (PT).
     Skilled nursing (SN).
     Speech-language pathology (SLP).
    To calculate the CY 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 0.9985. We apply the 
wage index budget neutrality factor in order to calculate the CY 2021 
national per-visit rates.

[[Page 39424]]

    The LUPA per-visit rates are not calculated using case-mix weights. 
Therefore, no case-mix weights budget neutrality factor is needed to 
ensure budget neutrality for LUPA payments. Lastly, the per-visit rates 
for each discipline are updated by the CY 2021 home health payment 
update percentage of 2.7 percent. The national per-visit rates are 
adjusted by the wage index based on the site of service of the 
beneficiary. The per-visit payments for LUPAs are separate from the 
LUPA add-on payment amount, which is paid for episodes that occur as 
the only episode or initial episode in a sequence of adjacent episodes. 
The CY 2021 national per-visit rates for HHAs that submit the required 
quality data are updated by the CY 2021 HH payment update percentage of 
2.7 percent and are shown in Table 9.
[GRAPHIC] [TIFF OMITTED] TP30JN20.097

    The CY 2021 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the CY 2020 HH payment update 
percentage of 2.7 percent minus 2 percentage points and are shown in 
Table 10.
[GRAPHIC] [TIFF OMITTED] TP30JN20.098

BILLING CODE 4120-01-C
    We are reminding 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 lowering of 
the 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 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 also stated that the information 
required for submitting an NOA for CYs 2022 and beyond 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. Also, for both the 
submission of the RAP in CY 2021 and the one-time NOA for CYs 2022 and 
beyond, we finalized a payment reduction if the HHA does not submit the 
RAP for CY 2021 or NOA for CYs 2022 and beyond 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 beyond, 
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

[[Page 39425]]

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).
(4) 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 occur as the only episode or as an initial episode 
in a sequence of adjacent episodes are adjusted by applying an 
additional amount to the LUPA payment before adjusting for area wage 
differences. In the CY 2014 HH PPS final rule (78 FR 72305), we changed 
the methodology for calculating the LUPA add-on amount by finalizing 
the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and 
1.6266 for SLP. We multiply the per-visit payment amount for the first 
SN, PT, or SLP visit in LUPA episodes that occur as the only episode or 
an initial episode in a sequence of adjacent episodes by the 
appropriate factor to determine the LUPA add-on payment amount.
    In the CY 2019 HH PPS final rule with comment 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 period of care or the 
initial 30-day period of care in a sequence of adjacent 30-day periods 
of care by the appropriate add-on factor (1.8451 for SN, 1.6700 for PT, 
and 1.6266 for SLP) to determine the LUPA add-on payment amount for 30-
day periods of care under the PDGM. For example, using the proposed CY 
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 $283.30 (1.8451 
multiplied by $153.54), subject to area wage adjustment.
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 HH 
services furnished in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), for episodes or visits ending on or after April 1, 2004, 
and before April 1, 2005, that the Secretary increase the payment 
amount that otherwise would have been made under section 1895 of the 
Act for the services by 5 percent. Section 5201 of the Deficit 
Reduction Act of 2003 (DRA) (Pub. L. 108-171) amended section 421(a) of 
the MMA. The amended section 421(a) of the MMA required, for HH 
services furnished in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), on or after January 1, 2006, and before January 1, 2007, 
that the Secretary increase the payment amount otherwise made under 
section 1895 of the Act for those services by 5 percent.
    Section 3131(c) of the Affordable Care Act amended section 421(a) 
of the MMA to provide an increase of 3 percent of the payment amount 
otherwise made under section 1895 of the Act for HH services furnished 
in a rural area (as defined in section 1886(d)(2)(D) of the Act), for 
episodes and visits ending on or after April 1, 2010, and before 
January 1, 2016. Section 210 of the MACRA amended section 421(a) of the 
MMA to extend the rural add-on by providing an increase of 3 percent of 
the payment amount otherwise made under section 1895 of the Act for HH 
services provided in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), for episodes and visits ending before January 1, 2018.
    Section 50208(a) of the BBA of 2018 amended section 421(a) of the 
MMA to extend the rural add-on by providing an increase of 3 percent of 
the payment amount otherwise made under section 1895 of the Act for HH 
services provided in a rural area (as defined in section 1886(d)(2)(D) 
of the Act), for episodes and visits ending before January 1, 2019.
(2) Rural Add-On Payments for CYs 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

[[Page 39426]]

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 proposed 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] TP30JN20.099

e. Proposed Payments for High-Cost Outliers Under the HH PPS
(1) Background
    Section 1895(b)(5) of the Act allows for the provision of an 
addition or adjustment to the home health payment amount otherwise made 
in the case of outliers because of unusual variations in the type or 
amount of medically necessary care. Under the HH PPS, outlier payments 
are made for episodes whose estimated costs exceed a threshold amount 
for each Home Health Resource Group (HHRG). The episode's estimated 
cost was established as the sum of the national wage-adjusted per visit 
payment amounts delivered during the episode. The outlier threshold for 
each case-mix group or partial episode payment (PEP) adjustment is 
defined as the 60-day episode payment or PEP adjustment for that group 
plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS, 
the FDL amount is calculated by multiplying the HH FDL ratio by a 
case's wage-adjusted national, standardized 60-day episode payment 
rate, which yields an FDL dollar amount for the case. The outlier 
threshold amount is the sum of the wage and case-mix adjusted PPS 
episode amount and wage-adjusted FDL amount. The outlier payment is 
defined to be a proportion of the wage-adjusted estimated cost that 
surpasses the wage-adjusted threshold. The proportion of additional 
costs over the outlier 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 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 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

[[Page 39427]]

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. 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 that 
the FDL ratio for 30-day periods of care in CY 2020 would need to be 
set at 0.63 for 30-day periods of care based on our simulations looking 
at both 60-day episodes that would span into CY 2020 and 30-day periods 
that begin in CY 2020. Given that CY 2020 is the first year of the PDGM 
and the change to a 30-day unit of payment, for CY 2021, we are 
proposing to maintain the fixed-dollar loss ratio of 0.63, as finalized 
for CY 2020.
4. The Use of Technology Under the Medicare Home Health Benefit
    In the first COVID-19 PHE IFC (85 FR 19230), we changed the plan of 
care requirements at Sec.  409.43(a) on an interim basis, for the 
purposes of Medicare payment, to state that the plan of care must 
include any provision of remote patient monitoring or other services 
furnished via a telecommunications system and 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. In the first COVID-19 
PHE IFC, we stated that we believe that this change will help to 
increase access to technologies, such as telemedicine and remote 
patient monitoring during the public health emergency for the COVID-19 
pandemic (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 emergency period. Specifically, section 3707 of 
the CARES Act requires, with respect to home health services furnished 
during the PHE for COVID-19, that the Secretary shall 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. We believe that the policies finalized on an 
interim basis meet the requirements of section 3707 of the CARES Act.
    We have also heard from stakeholders about the important role that 
technologies can play in the delivery of appropriate home health 
services outside of the current pandemic. In the first COVID-19 PHE IFC 
(85 FR 19230), we discussed the various applications of the technology 
that HHAs and industry representatives have reported utilizing prior to 
taking the steps necessary in meeting the social distancing required 
during the public health emergency for the COVID-19 pandemic. Although 
section 1895(e)(1)(A) of the Act prohibits payment for services 
furnished via a telecommunications system if such services substitute 
for in-person home health services ordered as part of a plan of care, 
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. We acknowledged that technology has 
become an integral part of medicine across the entire spectrum of 
healthcare, and that telemedicine, in particular has the potential to 
play a large role in enhancing the delivery of healthcare in the home. 
In the first COVID-19 PHE IFC, we included the following illustrative 
example of in-person visits and the use of telecommunications 
technology:
    A patient recently discharged from the hospital after coronary 
bypass surgery was receiving home health skilled nursing visits 3 times 
a week for medication management, teaching and assessment. The patient 
developed a fever, cough, sore throat and moderate shortness of breath 
and now has a confirmed COVID-19 diagnosis, which the doctor has 
determined can be safely managed at home with home health services. The 
patient has been prescribed new medications for symptom management and 
oxygen therapy to support the patient's respiratory status. The 
patient's home health plan of care was updated to include an in-person 
skilled nursing visit once a week to assess the patient and to monitor 
for worsening symptoms. The plan of care was updated also to include a 
video consultation twice a week between the skilled nurse and the 
patient for medication management, teaching and assessment, as well as 
to obtain oxygen saturation readings that the patient relays to the 
nurse during the consultation.
    With regards to payment under the HH PPS, if the primary reason for 
home health care is to provide care to manage the symptoms resulting 
from COVID-19, this 30-day period of care would be grouped into the 
Medication, Management, Teaching and Assessment (MMTA)-Respiratory 
clinical group, and it would be an early 30-day period of care with an 
institutional admission source. Assuming a medium functional impairment 
level with ``low'' comorbidities, the low-utilization payment 
adjustment (LUPA) threshold would be 4 visits. Regardless if the 
patient continued to receive the original 3 in-person skilled nursing 
visits per week (12 visits total in the 30-day period) rather than the 
once per-week in-person skilled nursing visits (4 visits total in the 
30-day period), the HHA would still receive the full 30-day payment 
amount (rather than paying per visit if the total number of visits was 
below the LUPA threshold). In this example, the use of technology is 
not a substitute for the provision of in-person visits as ordered on 
the plan of care, as the plan of care was updated to reflect a change 
in the frequency of the in-

[[Page 39428]]

person visits and to include ``virtual visits'' using 
telecommunications technology as part of the management of the home 
health patient. We believe the provision of in-person visits and 
encounters using telecommunications technology can also apply outside 
of the public health emergency. Decisions regarding the use of 
telecommunications technology would be determined based on patient 
needs identified during the comprehensive assessment and would be 
included as part of the individualized plan of care established and 
reviewed by the physician who establishes the plan of care.
    For these reasons, we are proposing to permanently finalize the 
amendment to Sec.  409.43(a) as outlined in the first COVID-19 PHE IFC 
(85 FR 19230). We are also proposing 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 propose to 
modify the instructions regarding this line on the cost report to 
reflect a broader use of telecommunications technology. Additionally, 
we propose to amend Sec.  409.46(e) to include not only remote patient 
monitoring, but other communications or monitoring services, consistent 
with the plan of care for the individual. Because stakeholders have 
identified significant up-front costs in incorporating and evaluating 
various forms of telecommunications systems into home health care, this 
would allow HHAs to confidently plan for the continued inclusion of 
telecommunications systems under the Medicare home health benefit and 
increase the tools available to promote patient involvement and 
autonomy and potentially more efficient home health care.
    We remind stakeholders that access to telecommunications technology 
must be inclusive, especially for those patients who may have 
disabilities where the use of technology may be more challenging. 
Section 504 of the Rehabilitation Act and the Americans with 
Disabilities Act 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 
504 should be referred to the Office of Civil Rights for further 
review. Likewise, we remind HHAs that the home health CoPs at Sec.  
484.50(f)(1) require that information must 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 
Americans with Disabilities Act 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''.\5\
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    \5\ State Operations Manual Appendix B--Guidance to Surveyors: 
Home Health Agencies. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_b_hha.pdf.
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    We also reiterate the expectation that services provided by 
telecommunications technology are services that could also be provided 
through an in-person visit. 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. Furthermore, a HHA cannot 
discriminate against any individual who is unable or unwilling to 
receive home health services that could be provided via 
telecommunications technology. In those circumstances, the HHA must 
provide such services through in-person visits as the intent of the 
Medicare home health benefit as defined in section 1861(m) of the Act 
is to provide items and services on a visiting basis in the 
individual's home.
    We solicit comments on our proposal to finalize the amendment to 
Sec.  409.43(a) as outlined in the first COVID-19 PHE IFC (85 FR 19230) 
to allow the use of telecommunications technology included as part of 
the home health plan of care as long as the use of such technology does 
not substitute for ordered in-person visits. We also solicit comments 
on our proposal 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.

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 rules:
     CY 2007 HH PPS final rule (71 FR 65888 through 65891).
     CY 2008 HH PPS final rule (72 FR 49861 through 49864).
     CY 2009 HH PPS update notice (73 FR 65356).
     CY 2010 HH PPS final rule (74 FR 58096 through 58098).
     CY 2011 HH PPS final rule (75 FR 70400 through 70407).
     CY 2012 HH PPS final rule (76 FR 68574).
     CY 2013 HH PPS final rule (77 FR 67092).
     CY 2014 HH PPS final rule (78 FR 72297).
     CY 2015 HH PPS final rule (79 FR 66073 through 66074).
     CY 2016 HH PPS final rule (80 FR 68690 through 68695).
     CY 2017 HH PPS final rule (81 FR 76752).
     CY 2018 HH PPS final rule (82 FR 51711 through 51712).
     CY 2019 HH PPS final rule with comment period (83 FR 
56547).
     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

[[Page 39429]]

    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, as outlined in Table 28 of the CY 2020 HH PPS final rule (84 FR 
60555).\6\
---------------------------------------------------------------------------

    \6\ The HHCAHPS has five component questions that together are 
used to represent one NQF-endorsed measure.
[GRAPHIC] [TIFF OMITTED] TP30JN20.100


[[Page 39430]]


    There are no proposals or updates in this proposed rule for the 
Home Health Quality Reporting Program.

B. Proposed 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 2 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 2 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 
are proposing 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.

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 Bipartisan Budget Act (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 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 on the basis of expected costs for 
clinically-defined episodes of care. For example, if a beneficiary is 
receiving an infusion drug during an inpatient hospital stay, the Part 
A payment for the drug, supplies, equipment, and drug administration is 
included in the diagnosis-related group (DRG) payment to the hospital 
under the Medicare inpatient prospective payment system. Beneficiaries 
are liable for the Medicare inpatient hospital deductible and no 
coinsurance for the first 60 days. Similarly, if a beneficiary is 
receiving an infusion drug while in a SNF under a Part A stay, the 
payment for the drug, supplies, equipment, and drug administration are 
included in the SNF prospective payment system payment. After 20 days 
of SNF care, there is a daily beneficiary cost-sharing amount through 
day 100 when the beneficiary becomes responsible for all costs for each 
day after day 100 of the benefit period.
    Under Medicare Part B, certain items and services are paid 
separately while other items and services may be packaged into a single 
payment together. For example, in an HOPD and in a physician's office, 
the drug is paid separately, generally at the average sales price (ASP) 
plus 6 percent (77 FR 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 
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

[[Page 39431]]

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.\7\ The MACs 
update Self-Administered Drug (SAD) exclusion lists on a quarterly 
basis.\8\
---------------------------------------------------------------------------

    \7\ 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.
    \8\ 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 for home infusion therapy under traditional 
Medicare, drugs are generally covered under Part B or Part D. Certain 
infusion pumps, supplies (including home infusion drugs and the 
services required to furnish the drug, (that is, preparation and 
dispensing), and nursing are covered in some circumstances through the 
Part B durable medical equipment (DME) benefit, the Medicare home 
health benefit, or some combination of these benefits. In accordance 
with section 50401 of the 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.\9\ 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.
---------------------------------------------------------------------------

    \9\ 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 
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

[[Page 39432]]

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),\10\ as the drugs covered during the temporary 
transitional period. In addition, section 1834(u)(7)(C) of the Act 
states that the Secretary shall assign to an appropriate payment 
category drugs which are covered under the DME LCD for External 
Infusion Pumps and billed under HCPCS codes J7799 (Not otherwise 
classified drugs, other than inhalation drugs, administered through 
DME) and J7999 (Compounded drug, not otherwise classified), or billed 
under any code that is implemented after the date of the enactment of 
this paragraph and included in such local coverage determination or 
included in subregulatory guidance as a home infusion drug.
---------------------------------------------------------------------------

    \10\ 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 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

[[Page 39433]]

includes subcutaneous infusions for therapy or prophylaxis, including 
certain subcutaneous immunotherapy infusions. Payment category 3 
includes intravenous chemotherapy infusions, including certain 
chemotherapy drugs and biologicals. The payment category for subsequent 
transitional home infusion drug additions to the LCD and compounded 
infusion drugs not otherwise classified, as identified by HCPCS codes 
J7799 and J7999, will be determined by the DME MACs.
    In accordance with section 1834(u)(7)(D) of the Act, each payment 
category is paid at amounts in accordance with the Physician Fee 
Schedule (PFS) for each infusion drug administration calendar day in 
the individual's home for drugs assigned to such category, without 
geographic adjustment. Section 1834(u)(7)(E)(ii) of the Act requires 
that in the case that two (or more) home infusion drugs or biologicals 
from two different payment categories are administered to an individual 
concurrently on a single infusion drug administration calendar day, one 
payment for the highest payment category will be made.
d. Summary of CY 2019 and CY 2020 Home Infusion Therapy Provisions
    In the CY 2019 Home Health Prospective Payment System (HH PPS) 
final rule with comment period (83 FR 56579) we finalized the 
implementation of the home infusion therapy services temporary 
transitional payments under paragraph (7) of section 1834(u) of the 
Act, 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 means that existing DME suppliers that are 
enrolled in Medicare as pharmacies that provide external infusion pumps 
and external infusion pump supplies, who comply with Medicare's DME 
Supplier and Quality Standards, and maintain all pharmacy licensure 
requirements in the State in which the applicable infusion drugs are 
administered, are considered eligible home infusion suppliers.
    Section 1834(u)(7)(C) of the Act assigns transitional home infusion 
drugs, identified by the HCPCS codes for the drugs and biologicals 
covered under the DME LCD for External Infusion Pumps (L33794),\11\ 
into three payment categories, for which we established a single 
payment amount in accordance with section 1834(u)(7)(D) of the Act. 
This section states that each single payment amount per category will 
be paid at amounts equal to the amounts determined under the PFS 
established under section 1848 of the Act for services furnished during 
the year for codes and units of such codes, without geographic 
adjustment. Therefore, we created a new HCPCS G-code for each of the 
three payment categories and finalized the billing procedure for the 
temporary transitional payment for eligible home infusion suppliers. We 
stated that the eligible home infusion supplier would submit, in line-
item detail on the claim, a G-code for each infusion drug 
administration calendar day. We stated that the claim should include 
the length of time, in 15-minute increments, for which professional 
services were furnished. The G-codes can be billed separately from, or 
on the same claim as, the DME, supplies, or infusion drug, and are 
processed through the DME MACs. On August 10, 2018, we issued Change 
Request: R4112CP: Temporary Transitional Payment for Home Infusion 
Therapy Services for CYs 2019 and 2020 \12\ outlining the requirements 
for the claims processing changes needed to implement this payment.
---------------------------------------------------------------------------

    \11\ 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&.
    \12\ 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 last, we finalized the definition of ``infusion drug 
administration calendar day'' in regulation as the day on which home 
infusion therapy services are furnished by skilled professional(s) in 
the individual's home on the day of infusion drug administration. The 
skilled services provided on such day must be so inherently complex 
that they can only be safely and effectively performed by, or under the 
supervision of, professional or technical personnel (42 CFR 486.505). 
Section 1834(u)(7)(E)(i) of the Act clarifies that this definition is 
with respect to the furnishing of ``transitional home infusion drugs'' 
and ``home infusion drugs'' to an individual by an ``eligible home 
infusion supplier'' and a ``qualified home infusion therapy supplier.'' 
The definition of ``infusion drug administration calendar day'' applies 
to both the temporary transitional payment in CYs 2019 and 2020 and the 
permanent home infusion therapy 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.
(1) Home Infusion Drugs
    In the CYs 2019 and 2020 Home Health Prospective Payment System (HH 
PPS) proposed rules (83 FR 32466 and 84 FR 34690) we discussed the 
relationship between the home infusion therapy 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

[[Page 39434]]

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),\13\ 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).\14\ 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.
---------------------------------------------------------------------------

    \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 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 34690).
(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 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

[[Page 39435]]

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).\15\ Additionally, DME suppliers 
are required to communicate directly with patients regarding their 
medications.
---------------------------------------------------------------------------

    \15\ 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.
---------------------------------------------------------------------------

    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.
(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 
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

[[Page 39436]]

bill for the services related to the administration of the home 
infusion drugs on the home infusion therapy services claim.
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 are not proposing to create a 
mandatory form nor are we otherwise proposing 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, 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 Table 12), 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 outlined in section 1834(u)(7)(C) of the 
Act, utilizes an already established framework for assigning a unit of 
single payment (per category), accounting for different therapy types, 
as required by section 1834(u)(1)(A)(ii) of the Act. The payment amount 
for each of these three categories is different, though each category 
has its associated single payment amount. The single payment amount 
(per category) would thereby reflect variations in nursing utilization, 
complexity of drug administration, and patient acuity, as determined by 
the different categories based on therapy type. Retaining the three 
current payment categories 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 with 2021. Table 12 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. As noted previously in 
this proposed rule, section 1861(iii)(3)(C) of the Act defines a home

[[Page 39437]]

infusion drug as a parenteral drug or biological administered 
intravenously or subcutaneously for an administration period of 15 
minutes or more, in the home of an individual through a pump that is an 
item of DME. Such term does not include the following: (1) Insulin pump 
systems; and (2) a self-administered drug or biological on a self-
administered drug exclusion list. Hizentra, a subcutaneous 
immunoglobulin, is not included in this definition of home infusion 
drugs because it is listed on a self-administered drug (SAD) exclusion 
list by the MACs. This drug was included as a transitional home 
infusion drug since the definition of such drug in section 
1834(u)(7)(A)(iii) of the Act does not exclude self-administered drugs 
or biologicals on a SAD exclusion list under the temporary transitional 
payment. Therefore, although home infusion therapy services related to 
the administration of Hizentra are covered under the temporary 
transitional payment, because it is on a SAD exclusion list, services 
related to the administration of this biological are not covered under 
the benefit in 2021. Similarly, in accordance with the definition of 
``home infusion drug'' as a parenteral drug or biological administered 
intravenously or subcutaneously, home infusion therapy services related 
to the administration of Ziconotide and Floxuridine are also excluded, 
as these drugs are given via intrathecal and intra-arterial routes 
respectively and therefore do not meet the definition of home infusion 
drug. 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. 
Subsequent drugs added to the DME LCD for external infusion pumps, and 
compounded infusion drugs not otherwise classified, as identified by 
HCPCS codes J7799 and J7999, would be grouped into the appropriate 
payment category by the DME MACs. Payment category 1 would include any 
subsequent intravenous infusion drug additions, payment category 2 
would include any subsequent subcutaneous infusion drug additions, and 
payment category 3 would include any subsequent intravenous 
chemotherapy or other highly complex drug or biologic infusion 
additions.

[[Page 39438]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.101

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

[[Page 39439]]

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 13.
[GRAPHIC] [TIFF OMITTED] TP30JN20.102

    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. Table 14 shows the 
E/M visit codes and PFS payment amounts for CY 2020, for both new and 
existing patients, used to determine the increased payment amount for 
the first visit. Using the CY 2020 PFS rates, this results in a 60 
percent increase in the first visit payment amount and a 3.72 percent 
decrease in subsequent visit amounts.
[GRAPHIC] [TIFF OMITTED] TP30JN20.103

    Table 15 shows the 5-hour payment amounts (using CY 2020 PFS rates) 
reflecting the increased payment for the first visit and the decreased 
payment for all subsequent visits. The payment amounts for this 
proposed rule are estimated using CY 2020 rates because the 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 in a CR 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.

[[Page 39440]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.104

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) 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).\16\ 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:
---------------------------------------------------------------------------

    \16\ GAF = (.50886 x Work GPCI) + (.44839 x PE GPCI) + (.04295 x 
MP GPCI).

---------------------------------------------------------------------------
Rate GAFi = GAF * UnadjRatei.

    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 for 
2020 the budget neutrality factor would be 0.9957. 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 proposed 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.
5. Proposed Home Infusion Therapy Services Excluded From the Medicare 
Home Health Benefit
    Section 1861(iii) of the Act 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.
    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

[[Page 39441]]

32467). In accordance with the definition of ``infusion drug 
administration calendar day'', the skilled services provided on an 
infusion drug administration calendar 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. Additionally, 
although we do not specify the entities that may provide the home 
infusion therapy services, we do state that the skilled provider must 
be furnishing services within the scope of his/her practice. While we 
do not outline an exhaustive list of services that are covered under 
the home infusion therapy services benefit, we outline the scope of 
services covered under the home infusion therapy services benefit in 
sub-regulatory guidance.\17\ This 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:
---------------------------------------------------------------------------

    \17\ 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.
    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.
    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 on January 1, 2021. 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. It is also 
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, 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. It is important to 
note 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. 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 propose to amend 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. Additionally, excluded home infusion 
therapy services 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.
    As discussed in the CY 2019 HH PPS proposed rule (83 FR 32469), 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.

B. Proposed Enrollment Standards 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. For example, part 414, subpart P outlines policies concerning 
home infusion therapy conditions of payment and plan of care 
requirements. Part 486, subpart I, outlines standards for home infusion 
therapy suppliers and specifies a definition of ``qualified home 
infusion therapy supplier'' at Sec.  486.505. 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:


[[Page 39442]]


     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.
    This final criterion, which reflects section 1861(iii)(3)(D)(i)(IV) 
of the Act, is of particular importance for purposes of this section 
V.B. of this proposed rule. One of our 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. We believe that 
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. Medicare Provider and Supplier Enrollment
a. Background
    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 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. 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. As further explained later in 
this section, CMS and its Medicare Administrative Contractors (MACs; 
hereafter occasionally referred to as ``contractors'') carefully and 
closely screen and review Medicare enrollment applicants to verify that 
they meet all applicable legal requirements.
    We have taken various steps via regulation to outline a process for 
enrolling providers and suppliers in the Medicare program. In the April 
21, 2006 Federal Register (71 FR 20754), we published the ``Medicare 
Program; Requirements for Providers and Suppliers to Establish and 
Maintain Medicare Enrollment'' final rule that set forth certain 
requirements in 42 CFR part 424, subpart P (currently Sec. Sec.  
424.500 through 424.570) (hereinafter occasionally referenced as 
subpart P) that providers and suppliers must meet to obtain and 
maintain Medicare billing privileges. In the April 21, 2006 final rule, 
we cited sections 1102 and 1871 of the Act as general authority for our 
establishment of these requirements, which were designed for the 
efficient administration of the Medicare program.
    Following the April 21, 2006 final rule, we published additional 
provider enrollment regulations. These were intended not only to 
clarify or strengthen certain components of the enrollment process but 
also to enable us to take further action against providers and 
suppliers: (1) Engaging (or potentially engaging) in fraudulent or 
abusive behavior; (2) presenting a risk of harm to Medicare 
beneficiaries or the Medicare Trust Funds; or (3) that are otherwise 
unqualified to furnish Medicare services or items. One such regulatory 
document was the February 2, 2011 final rule with comment period titled 
``Medicare, Medicaid, and Children's Health Insurance Programs; 
Additional Screening Requirements, Application Fees, Temporary 
Enrollment Moratoria, Payment Suspensions and Compliance Plans for 
Providers and Suppliers'' (76 FR 5862). Implementing various provisions 
of the Affordable Care Act, this final rule with comment period did the 
following:
     Added a new Sec.  424.514 that required submission of 
application fees by institutional providers (as that term is defined in 
Sec.  424.502) as part of the Medicare, Medicaid, and Children's Health 
Insurance Program (CHIP) provider enrollment processes.
     Added a new Sec.  424.518 that established Medicare, 
Medicaid, and CHIP provider enrollment screening categories and 
requirements based on the CMS-assessed level of risk of fraud, waste, 
and abuse posed by a particular category of provider or supplier.
    To further address existing provider enrollment vulnerabilities, we 
also published the following rules:
     The December 5, 2014 final rule titled ``Medicare Program; 
Requirements for the Medicare Incentive Reward Program and Provider 
Enrollment'' (79 FR 72499).
     The September 10, 2019 final rule with comment period 
titled ``Medicare, Medicaid, and Children's Health Insurance Programs; 
Program Integrity Enhancements to the Provider Enrollment Process'' (84 
FR 47794).
    Both rules expanded the number and types of grounds on which CMS 
can: (1) Deny a prospective provider's or supplier's enrollment in the 
Medicare program under Sec.  424.530; or (2) revoke the Medicare 
enrollment of an existing provider or supplier under Sec.  424.535. In 
addition, the September, 10, 2019 final rule with comment period:
     Implemented section 1866(j)(5) of the Act, which permits 
the Secretary to deny the enrollment of a Medicare, Medicaid, and CHIP 
provider or supplier if the latter has or had an affiliation with a 
provider or supplier that--(1) has uncollected debt; (2) has been or is 
subject to a payment suspension under a federal health care program; 
(3) has been or is excluded by the Office of Inspector General (OIG) 
from Medicare, Medicaid, or CHIP; or (4) has had its Medicare, 
Medicaid, or CHIP billing privileges denied or revoked.
     Increased the maximum reenrollment bar that prohibits a 
provider or supplier from reenrolling in Medicare after it is revoked 
from 3 to 10 years, with certain exceptions.
     Prohibited a provider or supplier from enrolling in 
Medicare for up to 3 years if its enrollment application is denied 
because the provider or supplier submitted false or misleading 
information on or with (or omitted information from) its application in 
order to enroll in Medicare.
    We have also conducted rulemaking that established enrollment 
requirements for specific, newly-recognized types of providers and 
suppliers, such as Medicare Diabetes Prevention Program suppliers in 
2017 (82 FR 52976) and Opioid Treatment Program providers in 2019 (84 
FR 62568).
b. Form CMS-855--Medicare Enrollment Application
    Under Sec.  424.510, a provider or supplier must complete, sign, 
and submit to its assigned MAC the appropriate Form CMS-855 (OMB 
Control No. 0938-0685) application in order to enroll in the Medicare 
program and obtain Medicare billing privileges. 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) captures 
information about the provider or supplier that is needed for CMS or 
its MACs to determine whether the provider or supplier meets all 
Medicare requirements. Data collected on the Form CMS-855 is carefully 
reviewed and verified by CMS or its MACs and includes, but is not 
limited to, the following:

[[Page 39443]]

     General identifying information (for example, legal 
business name, tax identification number).
     Licensure and/or certification data.
     Any final adverse actions (as that term is defined in 
Sec.  424.502) of the provider or supplier, such as felony convictions, 
OIG exclusions, or state license suspensions or revocations.
     Practice locations and other applicable addresses of the 
provider or supplier.
     Information regarding the provider's or supplier's owning 
and managing individuals and organizations and any final adverse 
actions those parties may have.
     As applicable, information about the provider's or 
supplier's use of a billing agency.
    The Form CMS-855 application is used for a number of provider 
enrollment transactions, such as the following:
     Initial enrollment: The provider or supplier is enrolling 
in Medicare for the first time, enrolling in another MAC's 
jurisdiction, or seeking to enroll in Medicare after having previously 
been enrolled.
     Change of ownership: The provider or supplier is reporting 
a change in its ownership.
     Revalidation: The provider or supplier is revalidating its 
Medicare enrollment information in accordance with Sec.  424.515.
     Reactivation: The provider or supplier is seeking to 
reactivate its Medicare billing privileges after being deactivated 
under Sec.  424.540.
     Change of information: The provider or supplier is 
reporting a change in its existing enrollment information in accordance 
with Sec.  424.516.
    After receiving a 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.
    We believe, and it has been our longstanding experience, that the 
provider enrollment process is invaluable in helping to ensure that: 
(1) All potential providers and suppliers are carefully screened for 
compliance with all applicable requirements; (2) problematic providers 
and suppliers are kept out of Medicare; and (3) beneficiaries are 
protected from unqualified providers and suppliers. Given CMS' 
responsibility in preventing waste and abuse in the Medicare program, 
we believe that the safeguards that Medicare enrollment furnishes are 
needed with respect to home infusion therapy suppliers.
2. Proposed Home Infusion Therapy Supplier Enrollment Provisions
    There are several principal legal bases for our proposed home 
infusion therapy enrollment requirements. First, as stated previously, 
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. (We interpret this latter 
proviso, however, to apply strictly to the establishment of standards 
of care as opposed to the creation of home infusion therapy supplier 
enrollment requirements.) 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.
a. Definition
    We propose to establish a new Sec.  424.68 that would encapsulate 
the preponderance of our home infusion therapy enrollment provisions. 
In paragraph (a) thereof, we propose to define ``home infusion therapy 
supplier.'' This definition would be largely consistent with the 
definition of ``qualified home infusion therapy supplier'' in section 
1861(iii)(3)(D)(i)(IV) of the Act and the aforementioned definition of 
the same term in Sec.  486.505, though with the addition of a specific 
enrollment requirement. A home infusion therapy supplier under Sec.  
424.68, for purposes of Sec.  424.68, would mean 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 propose 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. This 
overarching requirement would be consistent with that in 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 Enrollment
    Paragraph (c) would outline specific home infusion therapy supplier 
enrollment requirements. Some of these mirror the general enrollment 
provisions in subpart P, so we are duplicating them in Sec.  424.68 to 
clarify their applicability to home infusion therapy suppliers. 
However, the other requirements in Sec.  424.68(c) are unique to this 
supplier type.
(1) Submission of Form CMS-855
    In Sec.  424.68(c)(1)(i), we propose 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 believe that the Form CMS-855B is 
the most suitable enrollment application for home infusion therapy 
suppliers. In addition, we propose in Sec.  424.68(c)(1)(ii) 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 is to help ensure that the home infusion therapy 
supplier fully understands its obligation

[[Page 39444]]

to maintain constant compliance with the requirements associated with 
home infusion therapy supplier enrollment.
(2) Payment of Application Fee
    As mentioned previously in our discussion of the February 2, 2011 
final rule with comment period, prospective and revalidating 
institutional providers that are submitting an enrollment application 
generally must pay the applicable application fee in accordance with 
Sec.  424.514. (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. Because a home infusion 
therapy supplier would be required to complete the Form CMS-855B to 
enroll in Medicare as a home infusion therapy supplier (and would not 
be enrolling as a physician/non-physician organization), we believe 
that a home infusion therapy supplier would meet the definition of an 
institutional provider under Sec.  424.502. Therefore, home infusion 
therapy suppliers would be required to pay an application fee 
consistent with Sec.  424.514, and we accordingly propose to clarify 
this fee payment requirement in new Sec.  424.68(c)(2).
(3) Accreditation
    In general, accreditation of applicable CMS provider and supplier 
types helps ensure that the provider or supplier meets certain minimum 
requirements for furnishing health care services. The accreditation 
process frequently includes, but is not limited to, an accreditation 
survey. Such a survey typically involves an onsite review and 
evaluation of the provider's or supplier's operations, structure, and 
procedures to determine compliance with applicable federal standards. 
Title 42, part 488, subpart L, outlines, among other things, standards 
for accreditation organizations for home infusion therapy suppliers.
    We already indicated that the definition of ``qualified home 
infusion supplier'' in section 1861(iii)(3)(D)(i)(III) of the Act 
(codified in Sec.  486.505) requires the supplier to be accredited by 
an organization designated by the Secretary in accordance with section 
1834(u)(5) of the Act. To this end, we propose 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
    Part 486, subpart I, outlines certain standards to which home 
infusion therapy suppliers must adhere. For instance, Sec.  486.520 
identifies required components of a home infusion therapy supplier's 
plan of care; one such component is that all of the home infusion 
therapy supplier's patients must have a plan of care established by a 
physician that prescribes the type, amount, and duration of the home 
infusion therapy services to be furnished. Section 486.525, meanwhile, 
lists specific services that the home infusion therapy supplier must 
furnish.
    Additional home infusion therapy supplier provisions are contained 
in part 414, subpart P. For purposes of our proposed enrollment 
requirements, we believe the most pertinent of these are--
     Section 414.1505, which outlines several requirements that 
must be met for home infusion therapy services to be paid.
     Section 414.1515, which identifies plan of care 
requirements supplemental to those in Sec.  486.520(b).
    The aforementioned provisions in parts 486 and 414 reflect 
important quality standards and payment safeguards that should not, in 
our view, be entirely separate from our enrollment requirements. 
Indeed, these provisions, like our enrollment process, help ensure that 
the home infusion therapy supplier is qualified to furnish such 
services. Consequently, we propose the following:

     In new Sec.  424.68(c)(4), we propose 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 propose to add a new paragraph (c) 
stating that, along with the requirements for home infusion therapy 
payment listed 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) Home Infusion Therapy Suppliers: Categorical Risk Designation
    We previously referenced Sec.  424.518, which outlines screening 
categories and requirements based on a CMS assessment of the level of 
risk of fraud, waste, and abuse posed by a particular category of 
provider or supplier. In general, the higher the level of risk that a 
certain provider or supplier type 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 two additional 
functions under Sec.  424.518(c)(2). First, the MAC requires the 
submission of a set of fingerprints for a national background check 
from all individuals who maintain a 5 percent or greater direct or 
indirect ownership interest in the provider or supplier. Second, it 
conducts a fingerprint-based criminal history record check of the 
Federal Bureau of Investigation's (FBI) Integrated Automated 
Fingerprint Identification System on all individuals who maintain a 5 
percent or greater direct or indirect ownership interest in the 
provider or supplier. These additional verification activities are 
intended to correspond to the heightened risk involved with such 
provider or supplier type.
    We propose to add home infusion therapy suppliers to the types of 
providers and suppliers that are subject to the limited risk level of 
categorical screening. 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; more precisely, our review of home 
infusion therapy services furnished by other existing provider and 
supplier types generally

[[Page 39445]]

has not uncovered aberrant billing practices or significant fraud, 
waste, or abuse.
    Our specific regulatory revisions would involve: (1) Redesignating 
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
    We propose in new Sec.  424.68(d)(1)(i) and (ii), respectively, 
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 title; 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 are proposing that a home infusion 
therapy supplier may appeal the denial of its enrollment application 
under 42 CFR part 498.
    Section 424.68(d)(1)(i) is needed so CMS can ensure that 
unqualified home infusion therapy suppliers are kept out of the 
Medicare program. Concerning paragraphs (d)(1)(ii) and (2), the 
requirements in part 424, subpart P and the appeals provisions in part 
498 would apply to home infusion therapy suppliers to the same extent 
as they would to all other providers and suppliers. Thus, we believe it 
is appropriate to include paragraphs (d)(1)(ii) and (2) within Sec.  
424.68.
e. Continued Compliance, Standards, and Reasons for Revocation
    For reasons identical to those behind Sec.  424.68(c), we propose 
several provisions in new Sec.  424.68(e).
    In paragraph (e)(1), we propose to state 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 are proposing 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 propose 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 propose to include newly enrolling 
home infusion therapy suppliers within the scope of both Sec. Sec.  
424.520(d) and 424.521(a). We believe 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.

VI. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-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 are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):
    The following discusses the information collection requirements 
associated with Sec.  424.68. Specifically, 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.

1. Enrollment

    As discussed in section V.B.2. of this proposed 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 the application fee in accordance with Sec.  
424.514.
    Using existing accreditation statistics and our internal data, we 
generally estimate that: (1) There are about 600 home infusion therapy 
suppliers that would be eligible for Medicare enrollment under our 
proposed

[[Page 39446]]

provisions, all of whom would enroll in the initial year of our 
requirements; 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:
[GRAPHIC] [TIFF OMITTED] TP30JN20.105

    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 be responsible for securing and reporting data on the 
Form CMS-855B and that this task takes approximately 2 hours. 
Additionally, the form would be reviewed and signed by a health 
diagnosing and treating practitioner of the home infusion therapy 
supplier, a process we estimate takes 30 minutes. Therefore, we project 
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 estimate 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 welcome comments on all of these estimates.

2. Appeals

    As stated earlier in the preamble, newly proposed Sec.  
424.68(d)(2) and (e)(3) state that a home infusion therapy supplier may 
appeal 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; 
that is, the denial or revocation of a home infusion therapy supplier 
enrollment application. Therefore, we have not developed burden 
estimates. We also note 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, 
comparatively few denials and revocations of home infusion therapy 
supplier enrollments.

VII. Regulatory Impact Analysis

A. Statement of Need

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

[[Page 39447]]

we are proposing to adopt the new OMB delineations and apply a 5 
percent cap only in CY 2021 on any decrease in a geographic area's wage 
index value from the wage index value from the prior calendar year. 
This transition would allow the effects of our proposed 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 Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), the Congressional Review Act (5 U.S.C. 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 proposed 
rule:
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). The net transfer impact related to the changes in payments under 
the HH PPS for CY 2021 is estimated to be $540 million (2.6 percent). 
Therefore, we estimate that this rule is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared a 
Regulatory Impact Analysis that 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 proposed in this 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 proposed rule would have a not have significant economic 
impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a metropolitan statistical area and has fewer 
than 100 beds. This rule is not applicable to hospitals. Therefore, the 
Secretary has determined this final rule will not have a significant 
economic impact on the operations of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 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 proposed rule under these criteria 
of Executive Order 13132, and have determined that it will not impose 
substantial direct costs on state or local governments.
2. HH QRP
    We are not proposing 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. 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.

[[Page 39448]]

    There are no new proposals in this rule related to payments for 
home infusion therapy services in CY 202l. However, we estimate that 
the impact of updating the payment rates for home infusion therapy 
services for CY 2021, based on the PFS amounts for CY 2021, is no more 
than a 1 to 2 percent increase/decrease in payments ($1 million or 
less). The CY 2021 proposed PFS amounts were not available at the time 
of rulemaking; therefore, this estimate is based on the impact between 
the CY 2019 PFS amounts compared to the CY 2020 PFS amounts outlined in 
the CY 2020 HH PPS final rule with comment period (84 FR 60639).
5. Home Infusion Therapy Supplier Requirements
    As stated previously, we are proposing 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 cannot 
predict future changes to the CPI, the fee amounts between 2018 and 
2020 increased by an average of $13 per year. We believe this is a 
reasonable barometer with which to establish estimates (strictly for 
purposes of the proposed rule) of the fee amounts in the first 3 CYs of 
this rule (that is, 2021, 2022, and 2023). Thus, we project 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 estimate 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 constitutes an average annual figure over the 
first 3 years of this proposed requirement of $142,517). As referenced 
in Table 1 of this proposed rule, this would represent a transfer from 
home infusion therapy suppliers to the federal government.
    As noted in Table 1 and section VI.B.1. of this proposed 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.
6. Regulatory Review Cost Estimation
    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule, we must 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that would review the rule, we assume that the total number of unique 
reviewers of this year's proposed rule would be the similar to the 
number of commenters on last year's proposed rule. We acknowledge that 
this assumption may understate or overstate the costs of reviewing this 
rule. It is possible that not all commenters reviewed this year's rule 
in detail, and it is also possible that some reviewers chose not to 
comment on the proposed rule. For these reasons we believe that the 
number of past commenters would be a fair estimate of the number of 
reviewers of this rule. We welcome any comments on the approach in 
estimating the number of entities which would review this proposed 
rule. We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this proposed rule, 
and therefore for the purposes of our estimate we assume that each 
reviewer reads approximately 50 percent of the rule. We seek comments 
on this assumption. Using the wage information from the BLS for medical 
and health service managers (Code 11-9111), we estimate that the cost 
of reviewing this rule is $109.36 per hour, including overhead and 
fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm. Assuming 
an average reading speed of 250 words per minute, we estimate that it 
would take approximately 1.3 hours for the staff to review half of this 
proposed rule, which consists of approximately 39,000 words. For each 
HHA that reviews the rule, the estimated cost is $142.17 (1.3 hours x 
$109.36). Therefore, we estimate that the total cost of reviewing this 
proposed rule is $79,614 ($142.17 x 560 reviewers). For purposes of 
this estimate, the number of anticipated reviewers in this year's rule 
is equivalent to the number of commenters on the CY 2020 HH PPS 
proposed rule.

D. Detailed Economic Analysis

    This rule proposes updates to Medicare payments under the HH PPS 
for CY 2021. The impact analysis of this proposed rule presents the 
estimated expenditure effects of policy changes proposed in this rule. 
We use the latest data and best analysis available, but we do not make 
adjustments for future changes in such variables as number of visits or 
case mix. This analysis incorporates the latest estimates of growth in 
service use and payments under the Medicare HH benefit, based primarily 
on Medicare claims data 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 17 represents how HHA revenues are likely to be affected by 
the policy changes proposed in this rule for CY 2021. For this 
analysis, we used an analytic file with linked CY 2019 OASIS 
assessments and HH claims data for dates of service that ended on or 
before December 31, 2019. The first column of Table 17 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 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 
proposed in this rule.
    Overall, it is projected that aggregate payments in CY 2021 would 
increase by 2.6 percent. As illustrated in Table 17, 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

[[Page 39449]]

(LUPA) or paid as outlier payments, and the degree of Medicare 
utilization.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP30JN20.106


[[Page 39450]]


[GRAPHIC] [TIFF OMITTED] TP30JN20.107

BILLING CODE 4120-01-C

E. Alternatives Considered

    For the CY 2021 Home Health Prospective Payment Rate Update, we 
considered alternatives to the proposals articulated in section III.D 
of this proposed 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 proposal as 
shown in the regulatory impact analysis of this proposed 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 18, 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.

[[Page 39451]]

[GRAPHIC] [TIFF OMITTED] TP30JN20.108

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 proposed 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 proposed 
rule would result in an estimated net increase in HH payments of 2.6 
percent for CY 2021 ($540 million). The $540 million increase in 
estimated payments for CY 2021 reflects the effects of the CY 2021 home 
health payment update percentage of 2.7 percent ($560 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).
    This analysis, together with the remainder of this preamble, 
provides an initial Regulatory Flexibility Analysis.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 414

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

42 CFR Part 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 proposes to amend 42 CFR chapter IV as follows:

PART 409--HOSPITAL INSURANCE BENEFITS

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

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

0
2. Section 409.43 is amended by revising 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 a telecommunications system and 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.
    (C) A description of how the use of such technology will help to 
achieve the goals outlined on the plan of care.
    (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) technology; 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.

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

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

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

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


Sec.  414.1505   Requirement for payment.

* * * * *

[[Page 39452]]

    (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
7. The authority citation for part 424 continues to read as follows:

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

0
8. 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 of part 424, subpart 
P of this chapter.
    (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 part 424, subpart P of this chapter.
    (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 part 424, 
subpart P of this chapter.
    (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 of this title.
    (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 part 424, subpart P of this 
chapter.
    (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) Part 424, subpart P of this chapter;
    (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) Part 424, subpart P of this chapter;
    (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
9. 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
10. 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
11. 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
12. The authority citation for part 484 continues to read as follows:

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


Sec.  484.45   [Amended]

0
13. 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.


[[Page 39453]]


    Dated: June 12, 2020.
Seema Verma,
Administrator, Centers for Medicare and Medicaid Services.
    Dated: June 19, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-13792 Filed 6-25-20; 4:15 pm]
 BILLING CODE 4120-01-P