DEPARTMENT OF HEALTH AND HUMAN SERVICES purposes of the ...

This document is scheduled to be published in the Federal Register on 11/04/2020 and available online at d/2020-24146, and on

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 409, 410, 414, 424, and 484 [CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC] RINs 0938-AU06, 0938-AU31, and 0938-AU32 Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule updates the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This final rule also implements the changes to the home health regulations regarding the use of telecommunications technology in providing services under the Medicare home health benefit as described in the "Medicare and Medicaid Programs, Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency" interim final rule with comment period (March 2020 COVID-19 IFC). In addition, this rule implements the permanent home infusion therapy services benefit and supplier enrollment requirements for CY 2021 and finalizes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. This rule also finalizes a policy to align the Home Health Value-Based Purchasing (HHVBP) Model data submission requirements with any exceptions or extensions granted for purposes of the Home Health Quality Reporting Program (HH QRP) during the COVID-19 PHE

and also finalizes a policy for granting exceptions to the New Measures data reporting requirements during the COVID-19 PHE, as described in the "Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID?19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program" interim final rule with comment period (May 2020 COVID-19 IFC).

DATES: These regulations are effective on January 1, 2021. FOR FURTHER INFORMATION, CONTACT:

Brian Slater (410) 786-5229, for home health and home infusion therapy payment inquiries.

For general information about the Home Health Prospective Payment System (HH PPS), send your inquiry via email to: HomehealthPolicy@cms..

For general information about home infusion payment, send your inquiry via email to: HomeInfusionPolicy@cms..

For information about the Home Health Quality Reporting Program (HH QRP), send your inquiry via email to HHQRPquestions@cms..

Mary Rossi-Coajou, (410) 786-6051, for condition of participation (CoP) OASIS requirements.

For information about the Home Health Value Based Model, send your inquiry via email to HHVBPquestions@cms..

Joseph Schultz, (410) 786-2656, for information about home infusion therapy supplier enrollment requirements.

SUPPLEMENTARY INFORMATION: Wage index addenda will be available only through the CMS Coding and Billing

Information website at: . I. Executive Summary A. Purpose 1. Home Health Prospective Payment System (HH PPS)

This final rule updates the payment rates for home health agencies (HHAs) for calendar year (CY) 2021, as required under section 1895(b) of the Social Security Act (the Act). This rule sets forth the case-mix weights under section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for 30-day periods of care in CY 2021; the CY 2021 fixed-dollar loss ratio (FDL); and the loss-sharing ratio for outlier payments (as required by section 1895(b)(5)(A) of the Act). Additionally, this rule adopts the revised Office of Management and Budget (OMB) statistical area delineations as described in the September 14, 2018 OMB Bulletin No. 18-041 for the labor market delineations used in the home health wage index, effective beginning in CY 2021. This rule finalizes a cap on wage index decreases in excess of 5 percent and adopts the OMB statistical areas and the 5-percent cap on wage index decreases under the statutory discretion afforded to the Secretary under sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act. Lastly, this rule finalizes the changes to ? 409.43(a) as set forth in the interim final rule with comment period that appeared in the April 6, 2020 Federal Register titled "Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency"

1 On March 6, 2020, OMB issued the most recent OMB Bulletin No. 20-01.

(PHE) (March 2020 COVID-19 IFC), to state that the plan of care must include any provision of remote patient monitoring or other services furnished via a telecommunications system (85 FR 19230). 2. Home Health Quality Reporting Program (HH QRP)

We did not propose any changes for the HH QRP and therefore are not finalizing any policies in this final rule. 3. Changes to the Conditions of Participation (CoPs) OASIS Requirements

This final rule removes an obsolete provision that requires new HHAs that do not yet have a CMS certification number to conduct test OASIS data transmissions to the CMS data system as part of the initial certification process. 4. Reporting Under the Home Health Value Based Purchasing (HHVBP) Model During the COVID-19 PHE

This rule finalizes a policy to align HHVBP Model data submission requirements with any exceptions or extensions granted for purposes of the HH QRP as well as a policy for granting exceptions to the New Measures data reporting requirements during the COVID-19 PHE, as described in the interim final rule with comment period that appeared in the May 8, 2020 Federal Register titled "Medicare and Medicaid Programs; Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID?19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program " (85 FR 27553) (May 2020 COVID-19 IFC). 5. Home Infusion Therapy Services

This final rule summarizes the home infusion therapy policies codified in the CY 2020 HH PPS final rule with comment period (84 FR 60615), as required by section 1834(u) of the

Act. This rule also finalizes the exclusion of home infusion therapy services from coverage under the Medicare home health benefit as required by section 5012(c)(3) of the 21st Century Cures Act. 6. Enrollment Requirements for Qualified Home Infusion Therapy Suppliers

This final rule establishes Medicare provider enrollment policies for qualified home infusion therapy suppliers. B. Summary of the Provisions of this Rule

In section III.A of this rule, we set the LUPA thresholds and the case-mix weights for CY 2021 equal to the CY 2020 LUPA thresholds and case-mix weights established for the first year of the Patient-Driven Groupings Model (PDGM). The PDGM is a new case-mix adjustment methodology used to adjust payments for home health periods of care beginning on or after January 1, 2020. The PDGM relies more heavily on clinical characteristics and other patient information to place patients into meaningful payment categories and eliminates the use of therapy service thresholds, as required by section 1895(b)(4)(B) of the Act, as amended by section 51001(a)(3) of the Bipartisan Budget Act of 2018 (BBA of 2018).

Section III.B. of this rule adopts the OMB statistical area delineations outlined in a September 14, 2018, OMB bulletin No. 18-04. This rule also finalizes the transition with a 1-year cap on wage index decreases in excess of 5 percent, consistent with the policy finalized for other Medicare payment systems. This rule adopts the OMB statistical areas and the 5 percent cap on wage index decreases under the statutory discretion afforded to the Secretary under sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act.

In section III.C. of this rule, we update the home health wage index, the CY 2021 national, standardized 30-day period of care payment amounts and the CY 2021 national per-

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