35874 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 409, 424, 484, 488, 489, 

and 498 

[CMS–1747–P] 

RIN 0938–AU37 

Medicare and Medicaid Programs; CY 

2022 Home Health Prospective 

Payment System Rate Update; Home 

Health Value-Based Purchasing Model 

Requirements and Proposed Model 

Expansion; Home Health Quality 

Reporting Requirements; Home 

Infusion Therapy Services 

Requirements; Survey and 

Enforcement Requirements for 

Hospice Programs; Medicare Provider 

Enrollment Requirements; Inpatient 

Rehabilitation Facility Quality 

Reporting Program Requirements; and 

Long-Term Care Hospital Quality 

Reporting Program Requirements 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would set 

forth routine updates to the home health 

and home infusion therapy services 

payment rates for calendar year (CY) 

2022 in accordance with existing 

statutory and regulatory requirements. 

This rule also provides monitoring and 

analysis of the Patient-Driven Groupings 

Model (PDGM); solicits comments on a 

methodology for determining the 

difference between assumed versus 

actual behavior change on estimated 

aggregate expenditures for home health 

payments as result of the change in the 

unit of payment to 30 days and the 

implementation of the PDGM case-mix 

adjustment methodology; and proposes 

to recalibrate the PDGM case-mix 

weights, functional levels, and 

comorbidity adjustment subgroups 

while maintaining the low utilization 

payment adjustment (LUPA) thresholds 

for CY 2022. Additionally, this 

rulemaking proposes to utilize the 

physical therapy LUPA add-on factor to 

establish the occupational therapy addon factor for the LUPA add-on payment 

amounts; and make conforming 

regulations text changes to reflect that 

allowed practitioners are able to 

establish and review the plan of care. 

This rulemaking also proposes 

changes to the Home Health Quality 

Reporting Program (QRP) to remove one 

measure, remove two claims-based 

measures and replace them with one 

claims-based measure, publicly report 

two measures, propose a modification to 

the effective date for the reporting of the 

Transfer of Health to Provider-Post 

Acute Care and Transfer of Health to 

Patient-Post Acute Care (TOH) measures 

and Standardized Patient Assessment 

Data Elements and requests information 

on two topics: Advancing to digital 

quality measurement through the use of 

Fast Healthcare Interoperability 

Resources and our efforts surrounding 

closing the health equity gap. It also 

proposes modifications to the effective 

date for the reporting of TOH measures 

and certain Standardized Patient 

Assessment Data Elements. 

Additionally, this proposed rule 

requests information on two topics: 

Advancing to digital quality 

measurement through the use of Fast 

Healthcare Interoperability Resources 

and our efforts surrounding closing the 

health equity gap. It also proposes 

modifications to the effective date for 

the reporting of TOH measures and 

certain Standardized Patient 

Assessment Data Elements in the 

Inpatient Rehabilitation Facility (IRF) 

QRP and Long-Term Care Hospital 

(LTCH) QRP. In addition, this proposed 

rule would incorporate into regulation 

certain Medicare provider and supplier 

enrollment policies. 

In addition, this rulemaking proposes 

to make permanent selected regulatory 

blanket waivers related to home health 

aide supervision that were issued to 

Medicare participating home health 

agencies during the COVID–19 public 

health emergency (PHE), and would 

update the home health conditions of 

participation to implement Division CC, 

section 115 of the Consolidated 

Appropriations Act, 2021 (CAA 2021) 

regarding occupational therapists 

completing the initial and 

comprehensive assessments reflect these 

changes. 

This proposed rule also would 

expand the Home Health Value-Based 

Purchasing (HHVBP) Model, beginning 

January 1, 2022, to the 50 States, 

territories, and District of Columbia. 

This rulemaking also proposes to end 

the original HHVBP Model one year 

early for the home health agencies 

(HHAs) in the nine original Model 

States, such that CY 2020 performance 

data would not be used to calculate a 

payment adjustment for CY 2022 under 

the original Model. 

Additionally, this proposed rule 

establishes survey and enforcement 

requirements for hospice programs as 

set forth in Division CC, section 407, of 

the CAA 2021. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on August 27, 2021. 

ADDRESSES: In commenting, please refer 

to file code CMS–1747–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–1747–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–1747–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: 

Brian Slater, (410) 786–5229, for home 

health and home infusion therapy 

payment inquiries. For general 

information about home infusion 

payment, send your inquiry via email to 

HomeInfusionPolicy@cms.hhs.gov. 

For general information about the 

Home Health Prospective Payment 

System (HH PPS), send your inquiry via 

email to HomeHealthPolicy@

cms.hhs.gov. 

For more information about the Home 

Health Value-Based Purchasing Model, 

send your inquiry via email to 

HHVBPquestions@cms.hhs.gov. 

For information about the Home 

Health Quality Reporting Program (HH 

QRP), send your inquiry via email to 

HHQRPquestions@cms.hhs.gov. 

For information about the home 

health conditions of participation, 

contact Mary Rossi-Coajou at: 

mary.rossicoajou@cms.hhs.gov, James 

Cowher at james.cower@cms.hhs.gov, or 

Jeannine Cramer at Jeannine.cramer@

cms.hhs.gov. 

For provider and supplier enrollment 

process inquiries: Frank Whelan, (410) 

786–1302. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35875 

For information about the survey and 

enforcement requirements for hospice 

programs, send your inquiry via email 

to QSOG_Hospice@cms.hhs.gov. 

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. 

Table of Contents 

I. Executive Summary 

A. Purpose 

B. Summary of the Provisions of This Rule 

C. Summary of Costs, Transfers, and 

Benefits 

II. Home Health Prospective Payment System 

A. Overview of the Home Health 

Prospective Payment System 

B. Proposed Provisions for Payment Under 

the HH PPS 

III. Home Health Value-Based Purchasing 

(HHVBP) Model 

A. Proposal To Expand the HHVBP Model 

Nationwide 

B. Provisions Under the Home Health 

Value-Based Purchasing (HHVBP) 

Original Model 

IV. Home Health Quality Reporting Program 

(HH QRP) and Other Home Health 

Related Provisions 

A. Vaccinations for Home Health Agency 

Health Care Personnel 

B. Advancing Health Information Exchange 

C. Home Health Quality Reporting Program 

(HH QRP) 

D. Proposed Changes to the Home Health 

Conditions of Participation 

V. Home Infusion Therapy Services: Annual 

Payment Updates for CY 2022 

A. Home Infusion Therapy Payment 

Categories 

B. Payment Adjustments for CY 2022 

Home Infusion Therapy Services 

C. CY 2022 Payment Amounts for Home 

Infusion Therapy Services 

VI. Medicare Provider and Supplier 

Enrollment Changes 

A. Background—Provider and Supplier 

Enrollment Process 

B. Proposed Provisions 

VII. Survey and Enforcement Requirements 

for Hospice Programs 

A. Background 

B. Provisions of the Proposed Rule 

VIII. Requests for Information 

A. Fast Healthcare Interoperability 

Resources (FHIR) in Support of Digital 

Quality Measurement in Post-Acute Care 

Quality Reporting Programs—Request for 

Information 

B. Closing the Health Equity Gap in PostAcute Care Quality Reporting 

Programs—Request for Information 

IX. Revised Compliance Date for Certain 

Reporting Requirements Adopted for 

Inpatient Rehabilitation Facilities (IRF) 

QRP and Long-Term Care Facilities 

Quality QRP 

A. Proposal of a Revised Compliance Date 

for Certain Inpatient Rehabilitation 

Facility (IRF) QRP Reporting 

Requirements 

B. Proposal of a Revised Compliance Date 

for Certain Long-Term Care Hospital 

(LTCH) QRP Reporting Requirements 

X. Collection of Information Requirements 

A. Statutory Requirement for Solicitation 

of Comments 

B. Collection of Information Requirements 

C. Submission of PRA-Related Comments 

XI. Regulatory Impact Analysis 

A. Statement of Need 

B. Overall Impact 

C. Detailed Economic Analysis 

D. Limitations of Our Analysis 

E. Regulatory Review Cost Estimation 

F. Alternatives Considered 

G. Accounting Statement and Tables 

H. Regulatory Flexibility Act (RFA) 

I. Unfunded Mandates Reform Act (UMRA) 

J. Federalism 

K. Conclusion 

L. Executive Order 12866 

Regulations Text 

I. Executive Summary 

A. Purpose 

1. Home Health Prospective Payment 

System (HH PPS) 

This proposed rule provides 

preliminary monitoring analysis of the 

implementation of the PDGM, discusses 

the change in the unit of payment to 30 

days and the implementation of the 

PDGM case-mix adjustment 

methodology on estimated aggregate 

expenditures under the HH PPS, and 

includes a comment solicitation on the 

methodology for determining the 

difference between assumed versus 

actual behavior change on estimated 

aggregate expenditures for home health 

payments. This proposed rule would 

update the payment rates for HHAs for 

CY 2022, as required under section 

1895(b) of the Social Security Act (the 

Act). This rule also proposes to 

maintain the CY 2021 LUPA thresholds 

for CY 2022. However, the rule also 

proposes to recalibrate 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 2022. This 

proposed rule would update the CY 

2022 fixed-dollar loss ratio (FDL) for 

outlier payments (outlier payments as a 

percentage of estimated total payments 

are not to exceed 2.5 percent, as 

required by section 1895(b)(5)(A) of the 

Act). Finally, this rule proposes to use 

the physical therapy (PT) add-on factor 

to establish the occupational therapy 

(OT) LUPA add-on factor and proposes 

conforming regulations text changes at 

§ 409.43, ensuring the regulations reflect 

that allowed practitioners, in addition to 

physicians, may establish and 

periodically review the home health 

plan of care. 

2. Home Health Value Based Purchasing 

(HHVBP) Model 

In this proposed rule, we would 

expand the Home Health Value-Based 

Purchasing (HHVBP) Model to all 

Medicare-certified HHAs in the 50 

States, territories, and District of 

Columbia beginning January 1, 2022 

with CY 2022 as the first performance 

year and CY 2024 as the first payment 

year, based on HHA performance in CY 

2022. This rule also proposes to end the 

original HHVBP Model 1 year early for 

the HHAs in the nine original Model 

States, such that CY 2020 performance 

data would not be used to calculate a 

payment adjustment for CY 2022. 

3. Home Health (HH) Quality Reporting 

Program (HH QRP), Inpatient 

Rehabilitation Facility (IRF) QRP and 

Long-Term Care Hospital (LTCH) QRP 

This proposed rule would update the 

HH QRP by removing an OASIS-based 

measure, the Drug Education on All 

Medications Provided to Patient/ 

Caregiver During All Episodes of Care 

measure, from the HH QRP under 

measure removal factor 1: Measure 

performance among HHAs is so high 

and unvarying that meaningful 

distinctions in improvements in 

performance can no longer be made. 

This proposed rule also proposes to 

replace the Acute Care Hospitalization 

During the First 60 Days of Home Health 

(NQF #0171) measure and Emergency 

Department Use Without 

Hospitalization During the First 60 Days 

of Home Health (NQF #0173) measure 

with the Home Health Within Stay 

Potentially Preventable measure and 

proposes to publicly report the Percent 

of Residents Experiencing One or More 

Major Falls with Injury measure and 

Application of Percent of Long-Term 

Care Hospital Patients with an 

Admission and Discharge Functional 

Assessment and a Care Plan that 

Addresses Function (NQF #2631) 

measure beginning in April 2022. 

Finally, this proposed rule proposes 

revisions for certain HHA QRP reporting 

requirements. This proposed rule would 

also revise similar compliance dates for 

certain IRF QRP and LTCH QRP 

requirements. 

4. Proposed Changes to the Home 

Health Conditions of Participation 

In this rule, we propose to make 

permanent selected regulatory blanket 

waivers related to home health aide 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35876 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

supervision that were issued to 

Medicare participating home health 

agencies during the COVID–19 PHE. In 

addition, Division CC, section 115 of 

CAA 2021 requires CMS to permit an 

occupational therapist to conduct a 

home health initial assessment visit and 

complete a comprehensive assessment 

under the Medicare program, but only 

when occupational therapy is on the 

home health plan of care, with either 

physical therapy or speech therapy, and 

when skilled nursing services are not 

initially in the plan of care. 

We are proposing changes to the 

home health aide supervision 

requirements at § 484.80(h)(1) and 

§ 484.80(h)(2) and conforming 

regulation text changes at § 484.55(a)(2) 

and (b)(3), respectively, to allow 

occupational therapists to complete the 

initial and comprehensive assessments 

for patients in accordance with changes 

in the law. 

5. Medicare Coverage of Home Infusion 

Therapy 

This proposed rule includes updates 

to the home infusion therapy services 

payment rates for CY 2022, as required 

by section 1834(u) of the Act. 

6. Provider and Supplier Enrollment 

Processes 

In section VI. of this proposed rule, 

we address a number of provisions 

regarding Medicare provider and 

supplier enrollment. Most of these 

provisions involve the incorporation 

into 42 CFR part 424, subpart P of 

certain subregulatory policies. These are 

addressed in section VI.B. of this 

proposed rule and include, for example, 

policies related to: (1) The effective date 

of billing privileges for certain provider 

and supplier types and certain provider 

enrollment transactions; and (2) the 

deactivation of a provider or supplier’s 

billing privileges. 

In addition, we propose in section 

VI.C. of this proposed rule two 

regulatory clarifications related to HHA 

changes of ownership and HHA 

capitalization requirements. 

7. Survey and Enforcement 

Requirements for Hospice Programs 

In this proposed rule, CMS seeks to 

increase and improve transparency, 

oversight, and enforcement for hospice 

programs in addition to implementing 

the provisions of Division CC, section 

407(b) of CAA 2021. CMS continues to 

review and revise our health and safety 

requirements and survey processes to 

ensure that they are effective in driving 

quality of care for hospice programs. 

B. Summary of the Provisions of This 

Rule 

1. Home Health Prospective Payment 

System (HH PPS) 

In section II.B.1. of this rule, we 

provide data analyses on PDGM 

utilization since implementation of the 

new payment system in CY 2020. We 

describe a methodology for determining 

budget neutrality for CY 2020 and 

solicit comments on the difference 

between assumed versus actual behavior 

change on estimated aggregate 

expenditures. 

In section II.B.3. of this rule, we 

propose to recalibrate the PDGM casemix weights, functional levels, and 

comorbidity adjustment subgroups 

while proposing to maintain the CY 

2021 LUPA thresholds for CY 2022. The 

PDGM relies 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). 

In section II.B.4. of this rule, we 

propose to update the home health wage 

index, the CY 2022 national, 

standardized 30-day period payment 

amounts and the CY 2022 national pervisit payment amounts by the home 

health payment update percentage. The 

home health payment update percentage 

for CY 2022 is estimated to be 1.8 

percent. Additionally, this proposed 

rule proposes to update the FDL ratio to 

0.41 for CY 2022. 

In section II.B.4.(c).(5). of this 

proposed rule, we discuss the 

regulations under Division CC, section 

115 of CAA 2021 that revised 

§§ 484.55(a)(2) and 484.55(b)(3) to allow 

occupational therapists (OTs) to 

conduct initial and comprehensive 

assessments for all Medicare 

beneficiaries under the home health 

benefit when the plan of care does not 

initially include skilled nursing care. 

We propose to utilize the physical 

therapy (PT) LUPA add-on factor to 

establish the OT add-on factor for the 

LUPA add-on payment amounts. 

In section II.B.6. of this proposed rule, 

we are proposing conforming 

regulations text changes at § 409.43 to 

reflect that allowed practitioners, in 

addition to physicians, may establish 

and periodically review the home health 

plan of care in accordance with section 

3708 of the Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act) 

(Pub. L. 116–136, March 27, 2020). 

2. Home Health Value Based Purchasing 

(HHVBP) Model 

In section III.A. of this proposed rule, 

we are proposing to expand the HHVBP 

Model to all Medicare-certified HHAs in 

the 50 States, territories, and District of 

Columbia beginning January 1, 2022 

with CY 2022 as the first performance 

year and CY 2024 as the first payment 

year, with a proposed maximum 

payment adjustment, upward or 

downward, of 5-percent. We propose 

that the expanded Model would 

generally use benchmarks, achievement 

thresholds, and improvement thresholds 

based on CY 2019 data to assess 

achievement or improvement of HHA 

performance on applicable quality 

measures and that HHAs would 

compete nationally in their applicable 

size cohort, smaller-volume HHAs or 

larger-volume HHAs, as defined by the 

number of complete unique beneficiary 

episodes for each HHA in the year prior 

to the performance year. All HHAs 

certified to participate in the Medicare 

program prior to January 1, 2021 would 

be required to participate and eligible to 

receive an annual Total Performance 

Score based on their CY 2022 

performance. We propose the applicable 

measure set for the expanded Model, as 

well as policies related to the removal, 

modification, and suspension of quality 

measures, and the addition of new 

measures and the form, manner and 

timing of the OASIS-based, HHCAHPS 

survey-based, and claims-based 

measures submission in the proposed 

applicable measure set beginning CY 

2022 and subsequent years. We also 

include proposals for an appeals 

process, an extraordinary circumstances 

exception policy, and public reporting 

of annual performance data under the 

expanded Model. 

In section III.B. of this proposed rule, 

we propose to end the original HHVBP 

Model one year early. We propose that 

we would not use CY 2020 performance 

data for the HHAs in the nine original 

Model States to apply payment 

adjustments for the CY 2022 payment 

year. We also propose that we would 

not publicly report CY 2020 

(performance year 5) annual 

performance data under the original 

HHVBP Model. 

3. HH QRP 

In section IV.C. of this proposed rule, 

we propose updates to the HH QRP 

including: The removal of one OASISbased measure, replacement of two 

claims-based measures with one claimsbased quality measure; public reporting 

of two measures; revising the 

compliance date for certain reporting 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35877 

requirements for certain HH QRP 

reporting requirements and requests for 

information regarding digital quality 

measures and health equity. 

4. Proposed Changes to the Home 

Health Conditions of Participation 

In section IV.D. of this rule, we 

propose to make permanent selected 

regulatory blanket waivers related to 

home health aide supervision that were 

issued to Medicare participating home 

health agencies during the COVID–19 

PHE. In addition, Division CC, section 

115 of CAA 2021 requires CMS to 

permit an occupational therapist to 

conduct the initial assessment visit and 

complete the comprehensive assessment 

under the Medicare program, but only 

when occupational therapy is on the 

home health plan of care with either 

physical therapy or speech therapy and 

skilled nursing services are not initially 

on the plan of care. We are proposing 

changes to the home health aide 

supervision requirements at 

§ 484.80(h)(1) and (h)(2) and we are 

proposing conforming regulation text 

changes at § 484.55(a)(2) and (b)(3), 

respectively to allow occupational 

therapists completing the initial and 

comprehensive assessments for patients 

5. Medicare Coverage of Home Infusion 

Therapy 

In section V.A.1. of this proposed 

rule, we discuss the home infusion 

therapy services payment categories, as 

finalized in the CYs 2019 and 2020 HH 

PPS final rules with comment period 

(83 FR 56406, 84 FR 60611). In section 

V.A.2. of this proposed rule, we discuss 

the home infusion therapy services 

payment adjustments including a 

proposal to update the GAFs used for 

wage adjustment and a proposal to 

maintain the percentages finalized for 

the initial and subsequent visit policy. 

In section V.A.3. of this proposed rule, 

we discuss updates to the home 

infusion therapy services payment rates 

for CY 2022, as required by section 

1834(u) of the Act. 

6. Provider and Supplier Enrollment 

Processes 

In section VI. of this proposed rule, 

we address a number of provisions 

regarding Medicare provider and 

supplier enrollment. Most of these 

provisions involve the incorporation 

into 42 CFR part 424, subpart P of 

certain subregulatory policies. These are 

addressed in section VI.B. of this 

proposed rule and include, for example, 

policies related to: (1) The effective date 

of billing privileges for certain provider 

and supplier types and certain provider 

enrollment transactions; and (2) the 

deactivation of a provider or supplier’s 

billing privileges. 

In addition, we propose in section 

VI.C. of this proposed rule two 

regulatory clarifications related to HHA 

changes of ownership and HHA 

capitalization requirements. 

7. Survey and Enforcement 

Requirements for Hospice Programs 

In section VII. of this proposed rule, 

there are a number of provisions related 

to Division CC, section 407 of CAA 

2021. These proposed provisions 

enhance the hospice program survey 

process by requiring the use of 

multidisciplinary survey teams, 

prohibiting surveyor conflicts of 

interest, expanding CMS-based surveyor 

training to accrediting organizations 

(AOs), and requiring AOs with CMSapproved hospice programs to begin use 

of the Form CMS–2567. Additionally, 

the proposed provisions establish a 

hospice program complaint hotline. 

Finally, the proposed provisions create 

a Special Focus Program (SFP) for poorperforming hospice programs and the 

authority for imposing enforcement 

remedies for noncompliant hospice 

programs including the development 

and implementation of a range of 

remedies as well as procedures for 

appealing determinations regarding 

these remedies. 

Section 1865(a) of the Act provides 

that CMS may recognize and approve 

national AO Medicare accreditation 

programs which demonstrate that their 

health and safety standards and survey 

and oversight processes meet or exceed 

those used by CMS to determine 

compliance with applicable 

requirements. The CAA 2021 provisions 

expanding requirements for AOs will 

apply to AOs that accredit and ‘‘deem’’ 

hospice programs, and currently there 

are three such AOs: Accreditation 

Commission for Health Care (ACHC), 

Community Health Accreditation 

Partner (CHAP), and The Joint 

Commission (TJC). Half of all the 

Medicare-certified hospices have been 

deemed by these AOs. 

We describe and solicit comments on 

all aspects of these proposed survey and 

enforcement provisions for hospice 

programs. 

8. Inpatient Rehabilitation Facility 

Quality Reporting Program 

In section IX.A. of this proposed rule, 

we propose to modify the compliance 

date for certain reporting requirements 

in the IRF QRP. 

9. Long Term Care Hospital Quality 

Reporting Program 

In section IX.B. of this proposed rule, 

we propose to modify the compliance 

date for certain reporting requirements 

in the -LTCH QRP. 

C. Summary of Costs, Transfers, and 

Benefits 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35878 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

BILLING CODE 4120–01–C 

II. Home Health Prospective Payment 

System 

A. Overview of the Home Health 

Prospective Payment System 

1. Statutory Background 

Section 1895(b)(1) of the Act requires 

the Secretary to establish a Home Health 

Prospective Payment System (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. 

In accordance with the statute, as 

amended by the Balanced Budget Act of 

1997 (BBA), (Pub. L. 105–33, enacted 

August 5, 1997) we published a final 

rule in the July 3, 2000 Federal Register 

(65 FR 41128) to implement the HH PPS 

legislation. Section 4603(a) of the BBA 

allowed the Secretary to consider an 

appropriate unit of service and at such 

time, a 60-day unit of payment was 

established. 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, 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.000</GPH>

TABLE 1: SUMMARY OF COSTS, TRANSFERS, AND BENEFITS 

Provision Descriotion Costs and Cost Savine:s Transfers Benefits 

CY 2022 HH PPS Payment Rate The overall economic impact of the HH To ensure home health 

Update PPS payment rate update is an estimated payments are consistent with 

$310 million ( 1. 7 percent) in increased statutory payment authority 

payments to HHAs in CY 2022. for CY 2022. 

HHVBP The overall economic impact of the 

HHVBP Model for CYs 2022 through 

2026 is an estimated $3.154 billion in 

total savings to FFS Medicare from a 

reduction in unnecessary 

hospitalizations and SNF usage as a 

result of greater quality improvements 

in the HH industry. As for payments 

to HHAs, there are no aggregate 

increases or decreases expected to be 

applied to the HHAs competing in the 

model. 

HHQRP The total savings beginning in CY 

2023 is an estimated $2,762),77 

based upon the removal of one 

OASIS-based measure, item M2016. 

Changes to the Home Health We do not anticipate any costs or 

Conditions of Participation cost savings associated with our 

proposed Conditions of Participation 

orovisions. 

Medicare Coverage of Home The overall economic impact of To ensure that payment for 

Infusion Therapy updating the payment rates for home home infusion therapy 

infusion therapy services is expected to services are consistent with 

be minimal, based on the percentage statutory authority for CY 

increase in the CPI-U reduced by the 2022. 

productivity adjustment for CY 2022. 

The CPI-U for June 2021 was not yet 

available at the time of this proposed 

rule. 

Provider and Supplier Enrollment We do not anticipate any costs or The overall impact of our proposed 

Processes cost savings associated with our provider enrollment provisions would be 

proposed Medicare provider and a transfer of $54,145,000 from 

supplier enrollment provisions. providers/suppliers to the Federal 

government. This would result from our 

proposed provision prohibiting payment 

for services and items furnished by a 

deactivated provider or supplier. 

Survey and Enforcement We estimate that the proposal that We do not anticipate any transfers To ensure a comprehensive 

Requirements for Hospice Programs we present in the preamble of this associated with our proposed Medicare strategy to enhance the 

proposed rule to implement Division survey and enforcement requirements hospice program survey 

CC, section407 ofCAA2021 for hospice programs. process, increase 

would result in an estimated cost of accountability for hospice 

approximately $5.5 million from FY programs, and provide 

2021 through FY 2022. increased transparency to the 

public. 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35879 

enacted November 29, 1999). 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 home health agencies 

(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 

§ 484.225(h) and (i) in accordance with 

the statute. The pay-for-reporting 

requirement was implemented on 

January 1, 2007. 

Section 51001(a)(1)(B) of the 

Bipartisan Budget Act of 2018 (BBA of 

2018) (Pub. L. 115–123) 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 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. 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 Years 

For home health periods of care 

beginning on or after January 1, 2020, 

Medicare makes payment under the HH 

PPS on the basis of a national, 

standardized 30-day period payment 

rate that is adjusted for case-mix and 

area wage differences in accordance 

with section 51001(a)(1)(B) of the BBA 

of 2018. The national, standardized 30- 

day period payment rate includes 

payment for the six home health 

disciplines (skilled nursing, home 

health aide, physical therapy, speechlanguage pathology, occupational 

therapy, and medical social services). 

Payment for non-routine supplies (NRS) 

is now also 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 or is paid through 

the competitive bidding program and 

such payment is not included in the 

national, standardized 30-day period 

payment amount. 

To better align payment with patient 

care needs and to 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. The PDGM did not 

change eligibility or coverage criteria for 

Medicare home health services, and as 

long as the individual meets the criteria 

for home health services as described at 

42 CFR 409.42, the individual can 

receive Medicare home health services, 

including therapy services. For more 

information about the role of therapy 

services under the PDGM, we refer 

readers to the Medicare Learning 

Network (MLN) Matters article SE2000 

available at https://www.cms.gov/ 

regulations-and-guidanceguidance

transmittals2020-transmittals/se20005. 

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 categories under the 

PDGM, as shown in Figure 1. Each 

HHRG has an associated case-mix 

weight that is used in calculating the 

payment for a 30-day period of care. For 

periods of care with visits less than the 

low-utilization payment adjustment 

(LUPA) threshold for the HHRG, 

Medicare pays national per-visit rates 

based on the discipline(s) providing the 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35880 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

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). For certain 

cases that exceed a specific cost 

threshold, an outlier adjustment may 

also be available. 

Under this 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 (admission source, 

timing clinical grouping, functional 

impairment level, and comorbidity 

adjustment) using a fixed effects model. 

A detailed description of each of the 

case-mix variables under the PDGM 

have been described previously, and we 

refer readers to the CY 2021 HH PPS 

final rule (85 FR 70303 through 70305). 

B. Proposed Provisions for Payment 

Under the HH PPS 

1. Monitoring the Effects of the 

Implementation of PDGM 

a. Background 

The PDGM made several changes to 

the HH PPS, including replacing 60-day 

episodes of care with 30-day periods of 

care, removing therapy volume from 

directly determining payment, and 

developing 432 case-mix adjusted 

payment groups in place of the previous 

153 groups. In the CY 2020 HH PPS 

final rule with comment period (84 FR 

60513), we stated that continued 

monitoring is needed to understand 

how the PDGM, including the variables 

that determine the case-mix weights, 

affects the provision of home health care 

in order to inform any future 

refinements, if needed. 

CMS recognizes it takes time for 

HHAs to operationalize and adjust to a 

new payment system. We believe these 

adjustments are still occurring and 

HHAs are still adjusting to the new 

payment system given that these 

changes are the most significant changes 

to the HH PPS since its inception in 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.001</GPH>

FIGURE 1: CASE-MIX VARIABLES IN THE PDGM 

Admission Source and Timing (From Cl.aims) 

C()mt•'u•11tv 

Ear Iv 

CommW'l~V 

Ldtl' 

ln':'t·tut1or·al 

E,,mv 

I nstitut, on..:i, 

L,Jt,_, 

Clmica! Grouping (From Principal Diagnosis Reported on Claim) 

Ni~ur,) 

Pc,f,cih VVcund~ 

Mr,.nAC ... 1rd1,..1c 1.H"d 

CtrculJtory 

Cc1n1pl,r-·x 

Nu•,mq 

lntcrvL~nt10n•; 

~1MTA -

Endocrine 

f'-'S 

Rc-f,;:,b 

Mr,,.H,4 -

GliGU 

8t'fi2lVl~V'1[ 

HPalth 

Mt•'.T.4 -

ir,fe::t1C•U:, 

D1:,ec1s,,' 

' MM1:\ · 

' Oth.?r 

Functional Impairment level (From OASIS Items) 

Low Mediurn High 

i 

Cornorbidity Adjustment (Frorn Secondary Diagnoses 

Reported on Clain,s) 

None High 

HHRG 

(Home Health Resource Group) 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35881 

1https://www.phe.gov/emergency/news/health

actions/phe/Pages/2019-nCoV.aspx. 

2000. Additionally, the COVID–19 PHE 

was declared on January 31, 2020 and 

was retroactive to January 27, 2020.1

Therefore, any emerging trends may or 

may not be temporary, permanent, or 

unrelated to the implementation of the 

PDGM. Nevertheless, we understand 

stakeholders want to learn about how 

home health utilization patterns may 

have changed under the PDGM, so we 

are providing preliminary information 

in this proposed rule. 

b. Claims Data Overview Used in PDGM 

Monitoring 

We believe using actual claims data, 

whenever possible, will provide the 

most comprehensive and complete 

evaluation of changes before and after 

implementation of the PDGM. Prior to 

the PDGM, HHAs were paid a case-mix 

adjusted payment for 60-day episodes of 

care using one of the 153 HHRGs with 

various therapy utilization thresholds. 

Under the PDGM, HHAs are paid a casemix adjusted payment for 30-day 

periods of care using one of the 432 

HHRGs that do not include therapy 

thresholds. For our analysis, we used 

the analytic file described in the CY 

2020 HH PPS final rule with comment 

period (84 FR 60512) and applied the 

three behavioral assumptions to only 

half of the 30-day periods of care 

(randomly selected). That is, we used 

the CY 2018 home health data to divide 

one 60-day episode of care into two 

simulated 30-day periods of care that 

were used to set payment rates in the 

CY 2020 HH PPS final rule with 

comment period (84 FR 60518). We also 

used the analytic file described in the 

CY 2021 HH PPS final rule (85 FR 

70298) and applied the three behavioral 

assumptions to only half of the 30-day 

periods of care (randomly selected). 

That is, we used the CY 2019 home 

health data to divide one 60-day episode 

of care into two simulated 30-day 

periods of care that we used to for 

routine rate-setting updates and changes 

for CY 2021. The simulated data in 

these analytical files represent prePDGM utilization. We refer readers to 

the CY 2019 HH PPS proposed rule (83 

FR 32382 through 32388) for a detailed 

description of how these analytical files 

were created. Finally, we used CY 2020 

claims data as of March 30, 2021 to 

analyze utilization changes postimplementation of the PDGM and 30- 

day unit of payment. 

c. Routine PDGM Monitoring 

As noted previously, section 

1895(b)(3)(D) of the Act requires CMS to 

annually determine the impact of 

assumed versus actual behavior changes 

on aggregate expenditures under the HH 

PPS for CYs 2020 through 2026. 

Analyses for routine monitoring may 

include, but would not be limited to, 

analyzing: Overall total 30-day periods 

of care and average periods of care per 

HHA user; the distribution of visits in 

a 30-day period of care; the percentage 

of periods that receive the lowutilization payment adjustment (LUPA); 

the percentage of 30-day periods of care 

by clinical group, comorbidity 

adjustment, admission source, timing, 

and functional impairment level; and 

the proportion of 30-day periods of care 

with and without any therapy visits. As 

a reminder, the beginning of CY 2020 

included ongoing 60-day episodes of 

care that began in CY 2019 and ended 

in CY 2020. Depending on the length of 

the remainder of the episode, those 60- 

day episodes were simulated into one or 

two 30-day periods of care and are 

included in this year’s proposed rule 

monitoring tables. Approximately, 6.1 

percent of the 30-day periods of care in 

CY 2020 data were simulated because 

the original 60-day episode of care 

began in CY 2019 and ended in CY 

2020. We remind readers, our 

preliminary analysis described in this 

section is not tied to any quality 

program. 

(1) Utilization 

We evaluate utilization by comparing 

our simulated 30-day periods in our 

analytical files, to actual CY 2020 PDGM 

claims, as described previously. The 

analytic files used for annual ratesetting 

do not include all 60-day episodes or 

30-day periods of care because some of 

these episodes/periods are dropped for 

various reasons (for example, the claim 

could not be matched to an OASIS 

assessment). For all of the tables that 

follow, we examined utilization for CY 

2018 simulated 30-day periods of care, 

CY 2019 simulated 30-day periods of 

care, and CY 2020 actual 30-day periods 

of care. Table 2 shows the overall 

utilization of home health over time. 

Table 3 shows utilization of visits per 

30-day period of care by home health 

discipline over time. Preliminary data 

indicates while the number of 30-day 

periods of care decreased between CY 

2018 and CY 2020, the average number 

of 30-day periods of care per unique 

HHA user is similar. Additionally, our 

preliminary data indicates, on average, 

the number of visits per 30-day period 

of care for all disciplines decreased 

between CY 2018 and CY 2020. On 

average, the total number of visits 

decreased by 1.27 visits per 30-day 

period of care between CY 2018 and CY 

2020. Table 4 shows the proportion of 

30-day periods of care that are LUPAs 

and the average number of visits per 

discipline of those LUPA 30-day periods 

of care over time. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35882 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.002</GPH> EP07JY21.003</GPH>

TABLE 2: OVERALL UTILIZATION OF HOME HEALTH SERVICES, 

CYs 2018-2020 

CY2018 CY 2019 CY 2020 (Simulated) (Simulated) 

30-Dav Periods of Care 9,336,898 8,744,171 8,165,402 

Unique HHA Users 2 980,385 2 802,560 2 786 662 

Average Number of 30-Day Periods of care per Unique HHA User 3.13 3.12 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

Limited Data Set (LDS) file and we applied the three behavioral assumptions to half the claims (randomly selected). 

CY 2020 was accessed from the Chronic Conditions Data Warehouse (CCW) Virtual Research Data Center (VRDC) 

on March 30, 2021. 

Notes: There are approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not 

included in this analysis. All 30-day periods of care claims were included (for example LUP As, PEPs, and outliers). 

TABLE 3: UTILIZATION OF VISITS PER 30-DAY PERIODS OF CARE BY HOME 

HEALTH DISCIPLINE, CYs 2018-2020 

Discipline CY2018 CY2019 CY2020 (Simulated) (Simulated) 

Skilled Nursing 4.53 4.49 4.35 

Physical Therapy 3.30 3.33 2.71 

Occupational Therapy 1.02 1.07 0.78 

Speech Therapy 0.21 0.21 0.16 

Home Health Aide 0.72 0.67 0.54 

Social Worker 0.08 0.08 0.06 

Total (all disciplines) 9.86 9.85 8.59 

2.93 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

Notes: There are approximately 540,000 60-day episodes that started in 2019 and ended in 2020 that are not 

included in this analysis. All 30-day periods of care were included (for example LUPAs, PEPs, and outliers). 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35883 

2http://www.medpac.gov/docs/default-source/ 

reports/mar20_medpac_ch9_sec.pdf?sfvrsn=0. 

BILLING CODE 4120–01–C 

(2) Analysis of 2019 Cost Report Data for 

30-Day Periods of Care 

In the CY 2020 HH PPS final rule with 

comment period (84 FR 60483), we 

provided a summary of analysis on 

fiscal year (FY) 2017 HHA cost report 

data and how such data, if used, would 

impact our estimate of the percentage 

difference between Medicare payments; 

the CY 2020 30-day payment amount 

and estimated, average HHA costs for a 

30-day period of care. In that rule, we 

utilized FY 2017 cost reports and CY 

2017 home health claims to estimate 

both 60-day episode of care and 30-day 

period of care costs. We then updated 

the estimated CY 2017 60-day episode 

costs and 30-day period of care costs by 

the home health market basket update, 

reduced by the productivity adjustment 

for CYs 2018, 2019 and 2020 to 

calculate the 2020 estimated 60-day 

episode and 30-day period of care costs. 

As stated in the CY 2020 HH PPS final 

rule with comment period (84 FR 

60485), we estimated that the CY 2020 

30-day payment amount was 

approximately 16 percent higher than 

the average costs for a 30-day period of 

care. In MedPAC’s March 2020 Report 

to Congress,2 their review of home 

health payment adequacy found that 

‘‘access is more than adequate in most 

areas and that Medicare payments are 

substantially in excess of costs’’. 

In this proposed rule, we examined 

2019 HHA Medicare cost reports, as this 

is the most recent and complete cost 

report data at the time of rulemaking, 

and CY 2020 30-day period of care 

home health claims, to estimate 30-day 

period of care costs. We excluded 

LUPAs and PEPs in the average number 

of visits. The 2019 average NRS costs 

per visit is $3.94. We updated the 

estimated 30-day period of care costs, 

2019 average costs per visit with NRS by 

the CY 2020 home health market basket 

update, reduced by the productivity 

adjustment of 2.6 percent. Table 5 

shows the estimated average costs for 

30-day periods of care by discipline 

with NRS and the total 30-day period of 

care costs with NRS for CY 2020. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.004</GPH>

TABLE 4: THE PROPORTION OF 30-DAY PERIODS OF CARE THAT ARE LUPAs 

AND THE AVERAGE NUMBER OF VISITS BY HOME HEALTH DISCIPLINE 

FOR LUPA HOME HEALTH PERIODS, CYs 2018-2020 

CY CY 

2018 2019 CY Discipline (Simula (Sim 2020 ulate ted) d) 

Total percentage of overall 30-dav periods of care that are LUPAs 6.7% 6.8% 8.6% 

Discipline (Average# of visits for LUPA home health periods) 

Skilled Nursing 1.15 1.14 1.19 

Physical Theraov 0.43 0.46 0.53 

Occupational Theraov 0.07 0.07 0.08 

Speech Therapy 0.02 0.02 0.02 

Home Health Aide 0.01 0.01 0.01 

Social Worker 0.01 0.01 0.01 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

Notes: The average (CY 2018 to CY 2020) number of visits per 30-day periods of care across all claims for skilled 

nursing is 4.46, for physical therapy is 3.13, for occupational therapy is 0.97, for speech therapy is 0.19, for home 

health aid is 0.65, and for social worker is 0.07. There are approximately 540,000 60-day episodes that started in 

2019 and ended in 2020 that are not included in this analysis. 
35884 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

3http://www.medpac.gov/docs/default-source/ 

reports/mar21_medpac_report_to_the_congress_

sec.pdf?sfvrsn=0. 

4 Ibid. 

The CY 2020 national, standardized 

30-day period payment rate was 

$1,864.03, which is approximately 34 

percent more than the estimated CY 

2020 30-day period cost of $1,394.68. 

Note that in the CY 2020 HH PPS final 

rule with comment period (84 FR 

60484), the estimated average number of 

visits for a 30-day period of care in 2017 

was estimated to be 10.5 visits. Using 

actual CY 2020 claims data, the average 

number of visits in a 30-day period was 

9.25 visits—a decrease of approximately 

12 percent. We recognize that with the 

COVID–19 PHE, the 2019 data on the 

Medicare cost reports may not reflect 

the most recent changes such as 

increased telecommunications 

technology costs, increased personal 

protective equipment (PPE) costs, and 

hazard pay. In its March 2021 Report to 

Congress, to estimate Medicare margins 

for 2021, MedPAC assumed a cost 

growth of 3 percent for CY 2020 (2 

percentage points due to inflation and 

higher expenses for PPE and telehealth 

and 1 percentage point due to temporary 

surge pricing for PPE and other 

temporary costs of the PHE).3

Furthermore, MedPAC noted that for 

more than a decade, payments under the 

HH PPS have significantly exceeded 

HHAs’ costs primarily due to two 

factors—agencies reducing visits to 

reduce episode costs and cost growth in 

recent years has been lower than the 

annual payment updates.4 As shown in 

Table 3 in this proposed rule, HHAs 

have reduced visits under the PDGM in 

CY 2020. When the 2020 cost reports 

become available, we will update the 

estimated 30-day period of care costs in 

CY 2020 in future rulemaking. 

(3) Clinical Groupings and 

Comorbidities 

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 the home health claim. 

Table 6 shows the distribution of the 12 

clinical groups over time. We also 

include the average case-mix weight for 

all 30-day periods in each of the clinical 

groups in CY 2020. In other words, the 

average case-mix weight for each 

clinical group includes all possible 

comorbidity adjustments, admission 

source and timing, and functional 

impairment levels. We refer readers to 

Table 16 in the CY 2020 HH PPS final 

rule with comment period (84 FR 60522 

through 60533) for the CY 2020 PDGM 

LUPA threshold and case mix weight for 

each HHRG payment group. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.005</GPH>

TABLE 5: ESTIMATED COSTS FOR30-DAY PERIODS OF CARE IN CY 2020 

Discipline 2019 Average 2020 Average 2020 Market 2020 Estimated 

Costs per visit Number of Visits Basket Update 30-Day Period 

with NRS Costs 

Skilled Nursing $142.75 4.66 1.026 $682.51 

Physical Therapy $160.85 2.92 1.026 $481.89 

Occupational Therapy $160.14 0.85 1.026 $139.66 

Speech Pathology $181.27 0.17 1.026 $31.62 

Medical Social Services $238.66 0.06 1.026 $14.69 

Home Health Aides $73.20 0.59 1.026 $44.31 

Total $1,394.68 

Source: 2019 Medicare cost report data obtained on January 26, 2021. Home health visit information came from episodes 

ending on or before December 31, 2019 (obtained from the CCW VRDC on July 13, 2020). 

Note: The 2020 average number of visits excludes LUPAs and PEPs. 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35885 

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. We refer readers to section 

II. of this proposed rule and the CY 2020 

final rule with comment period (84 FR 

60493) for further information on the 

categories of the comorbidity 

adjustment. Home health 30-day periods 

of care can receive a low or a high 

comorbidity adjustment, or no 

comorbidity adjustment. Table 7 shows 

the distribution of 30-day periods of 

care by comorbidity adjustment category 

for all 30-day periods. We also include 

the average case-mix weight for each of 

the comorbidity adjustments in CY 

2020. In other words, the average casemix weight for each comorbidity 

adjustment includes all possible clinical 

groupings, admission source and timing, 

and functional impairment levels. 

(4) Admission Source and Timing 

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 receiving home health 

care. 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. Thirty-day 

periods of care are classified as ‘‘early’’ 

or ‘‘late’’ depending on when they occur 

within a sequence of 30-day periods of 

care. 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 

subsequent 30-day period of care would 

not be considered early unless there is 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.006</GPH> EP07JY21.007</GPH>

TABLE 6: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY THE 12 PDGM 

CLINICAL GROUPS, CYs 2018-2020 

CY 2018 CY 2019 Average Case-mix 

Clinical Grounin!! (Simulated) (Simulated) CY 2020 Wei!!ht for Each Groun 

Behavioral Health 1.7% 1.5% 2.3% 0.8243 

Comolex 2.6% 2.5% 3.5% 0.8574 

MMTA - Cardiac 16.5% 16.1% 19.0% 0.9202 

MMTA - Endocrine 17.3% 17.4% 7.2% 1.0161 

MMTA-GI/GU 2.2% 2.3% 4.7% 0.9793 

MMT A - Infectious 2.9% 2.7% 4.8% 0.9805 

MMTA-Other 4.7% 4.7% 3.1% 0.9711 

MMT A - Resoiratorv 4.3% 4.1% 7.8% 0.9906 

MMT A - Surgical Aftercare 1.8% 1.8% 3.5% 1.0701 

MS Rehab 17.1% 17.3% 19.4% 1.1174 

Neuro 14.4% 14.5% 10.5% 1.1603 

Wound 14.5% 15.1% 14.2% 1.1923 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

Note: The average case mix weight for each clinical group includes all 30-day periods regardless of other 

adjustments (for example admission source, timing, comotbidities, etc.) 

TABLE 7: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY COMORBIDITY 

ADJUSTMENT CATEGORY FOR 30-DA Y PERIODS, CY s 2018-2020 

Comorbidity CY 2018 CY 2019 Average Case-mix 

Adjustment (Simulated) (Simulated) CY 2020 Weight for Each 

Group 

None 55.6% 52.0% 49.2% 1.0058 

Low 35.3% 38.0% 36.9% 1.0446 

High 9.2% 10.0% 14.0% 1.1683 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

Note: The average case mix weight for each clinical group includes all 30-day periods regardless of other 

adjustments (for example admission source, timing, clinical group, etc.) 
35886 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

5Overview of the Home Health Groupings Model. 

November 18, 2016. https://downloads.cms.gov/

files/hhgm%20technical%20report%20120516

%20sxf.pdf. 

a gap of more than 60 days between the 

end of one previous 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’’. Table 

8 shows the distribution of 30-day 

periods of care by admission source and 

timing over time. We also include the 

average case-mix weight for each of the 

admission source and period timing in 

CY 2020. In other words, the average 

case-mix weight for each admission 

source and period timing includes all 

possible clinical groupings, comorbidity 

adjustment, and functional impairment 

levels. We refer readers to Table 16 in 

the CY 2020 HH PPS Final Rule with 

comment period (84 FR 60522 through 

60533) for the CY 2020 PDGM LUPA 

threshold and case mix weight for each 

HHRG payment group. 

(5) Functional Impairment Level 

Each 30-day period of care is placed 

into one of three functional impairment 

levels (low, medium, or high) based on 

responses to certain OASIS functional 

items associated with grooming, 

bathing, dressing, ambulating, 

transferring, and risk for hospitalization. 

The specific OASIS items that are used 

for the functional impairment level are 

found in Table 7 in the CY 2020 HH PPS 

final rule with comment period (84 FR, 

60490). Responses to these OASIS items 

are grouped together into response 

categories with similar resource use and 

each response category has associated 

points. A more detailed description as 

to how these response categories were 

established can be found in the 

technical report, ‘‘Overview of the 

Home Health Groupings Model’’ posted 

on the HHA web page.5 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 

that warranted an ‘‘other follow-up’’ 

assessment prior to the second 30-day 

period of care. For each 30-day period 

of care, the Medicare claims processing 

system will look for the most recent 

OASIS assessment based on the claims 

‘‘from date.’’ Table 9 shows the 

distribution of 30-day periods by 

functional status. We also include the 

average case-mix weight for each 

functional impairment level in CY 2020. 

In other words, the average case-mix 

weight for each functional impairment 

level includes all possible clinical 

groupings, comorbidity adjustment, and 

admission source and period timing. We 

refer readers to Table 16 in the CY 2020 

HH PPS Final Rule with comment 

period (84 FR 60522 through 60533) for 

the CY 2020 PDGM LUPA threshold and 

case mix weight for each HHRG 

payment group. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.008</GPH> EP07JY21.009</GPH>

TABLE 8: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY ADMISSION 

SOURCE AND PERIOD TIMING, CYs 2018-2020 

Admission Period CY 2018 CY 2019 Average Case-mix 

Source Timing (Simulated) (Simulated) CY 2020 Weight for Each 

Group 

Community Early 13.5% 13.8% 12.5% 1.2584 

Community Late 61.1% 60.9% 61.9% 0.8504 

Institutional Early 18.6% 18.4% 19.9% 1.4234 

Institutional Late 6.8% 6.9% 5.8% 1.3303 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

TABLE 9: DISTRIBUTION OF 30-DAY PERIODS OF CARE BY FUNCTIONAL 

IMPAIRMENT LEVEL, CYs 2018-2020 

Functional CY 2018 CY 2019 Average Case mix 

Impairment Level (Simulated) (Simulated) CY 2020 Weight for Each 

Group 

Low 33.9% 31.9% 25.6% 0.8392 

Medium 34.9% 35.5% 32.7% 1.0373 

High 31.2% 32.6% 41.7% 1.1724 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35887 

Currently, the functional impairment 

level is determined by responses to 

certain OASIS items associated with 

functional activities of daily living and 

risk of hospitalization; that is, responses 

to OASIS items M1800–M1860 and 

M1032. However, the Improving 

Medicare Post-Acute Care 

Transformation Act of 2014 (IMPACT 

Act) (Pub. L. 113–185, enacted on 

October 6, 2014) amended Title XVIII of 

the Act to include enacting new data 

reporting requirements for certain postacute care (PAC) providers, including 

HHAs. Sections 1899B(b)(1)(A) of the 

Act requires the Secretary to require 

home health agencies to report 

standardized patient assessment data 

beginning no later than January 1, 2019. 

The standardized patient assessment 

data categories include functional 

status, such as mobility and self-care at 

admission and discharge, in accordance 

with 1899B(b)(1)(B)(i) of the Act. As 

such, CMS finalized adding the 

functional items, Section GG, 

‘‘Functional Abilities and Goals’’, to the 

OASIS data set, effective January 1, 

2019, in order to be able to measure 

functional status across PAC providers. 

At the time of CY 2020 rulemaking, we 

did not yet have the data to determine 

the effect, if any, of these newly added 

items on resource costs utilization 

during a home health period of care for 

use in the PDGM. Therefore, the GG 

functional items are not currently used 

to determine the functional impairment 

level under the PDGM. 

We have examined the correlation 

between the current functional items 

used for payment (that is, M1800–1860) 

and the analogous GG items. We note 

that M1032, Risk for Hospitalization, 

does not have a corresponding GG item. 

Our preliminary analysis shows there is 

a correlation between the current 

responses to the M1800–1860 items and 

the GG items. However, there are certain 

information in M1800 items that are 

being collected at follow-up that are not 

collected with GG items (for example, 

the M1800 items associated with upper 

and lower body dressing are collected at 

follow up). Additionally, the GG items 

include an ‘‘Activity Not Attempted’’ 

(ANA) option, meaning the clinician did 

not put a response for the patient. 

Furthermore, there are a variety of ANA 

responses, including ‘‘Not attempted 

due to medical or safety concerns’’, and 

‘‘Not applicable’’. Figure 2 shows the 

frequencies by response type in CY 2020 

to the OASIS GG items. 

Our analysis of the GG items shows a 

significant amount of these ANA 

responses, making it difficult to map to 

the corresponding M1800–1860 item 

responses. Therefore, we will continue 

to monitor the GG items to determine 

the correlation between the current 

functional items used to case-mix adjust 

home health payments and the GG 

items, and we will provide additional 

analysis of the GG functional items in 

future rulemaking. 

(6) Therapy Visits 

Beginning in CY 2020, section 

1895(b)(4)(B)(ii) of the Act eliminated 

the use of therapy thresholds in 

calculating payments for CY 2020 and 

subsequent years. Prior to 

implementation of the PDGM, HHAs 

could receive an adjustment to payment 

based on the number of therapy visits 

provided during a 60-day episode of 

care. As such, we examined the 

proportion of simulated 30-day periods 

with and without any therapy visits for 

CYs 2018 and 2019, prior to the removal 

of therapy thresholds. We also 

examined the proportion of actual 30- 

day periods of care with and without 

therapy visits for CY 2020, after the 

removal of therapy thresholds. To be 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.010</GPH>

FIGURE 2: OASIS GG ITEM FREQUENCIES BY RESPONSE TYPE IN CY 2020 

100% 

~ 90% 0 80% -~ 70% 

~ 60% 

'cl 50% 

i:= 40% (1.) 30% ~ 20% ~ 10% 

0% 

&Si% Periods with Response %Periods with AN A 

>-. >-. t l:l OJ) :i:: ,,:;; I-, 

,,:;; ,,:;; .s § ~ 0 0 (,,:j 01) C.l'J r.tl 

,.0 ,.0 (1.) -~ ;;.--, .s .... :;. - § r.tl I-, I-, 

~ "a 0 

~ B ti (1.) (1.) § ..... 0, ::; 0 .-<;:: .,.., ..... I-, 

8- 0 r..., ()::; ;..,-, ..... '@ r:.ri r:.ri ....:l (1.) ....:l ..,q 

- u --

& 

.... 

(1.) ,:S + ~ .,..., ·X· 

~ ..... 

(I) 

-, 

0 .... 

(1.) ~ 

..:.:: ~ 0 

C\1 lf"l 0 ....., 

~ •.n ..:.:: ..:.:: C\1 C\1 ~ ~ 

OASIS GG Item 

- * + § * i1 r.tl "X· 0 i::::.. C.l'J §' •n (1.) (.) i::::.. '--" tl (1.) -(1.) .... O.I) 

~ 0-, ~ r.tl 1:1 (1.) N ~ ,...., ;s;1 

(.) ...... . .... 

i:i., 

Source: CY 2020 home health periods linked to OASIS data accessed from the CCW VRDC on March 30, 2021. 

Sample composed of 8,791,804 home health periods ending in 2020. 

Notes: +Item is not collected on the follow-up assessment. *Item is skipped if a prior item has an ANA response. 

Wheel 50 and Wheel 150 are skipped if the patient is not indicated as using a wheelchair. 
35888 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

6Medicare Benefit Policy Manual, Chapter 7 

Home Health Services, Section 40.2 Skilled 

Therapy Services https://www.cms.gov/Regulations- and-Guidance/Guidance/Manuals/Downloads/ 

bp102c07.pdf. 

covered as skilled therapy, the services 

must require the skills of a qualified 

therapist (that is, PT, OT, or SLP) or 

qualified therapist assistant and must be 

reasonable and necessary for the 

treatment of the patient’s illness or 

injury.6 As shown in Table 3, we are 

monitoring the number of visits per 30- 

day periods of care by each home health 

discipline. Any 30-day period of care 

can include both therapy and nontherapy visits. If any 30-day period of 

care consisted of only visits for PT, OT, 

and/or SLP, then this 30-day period of 

care is considered ‘‘therapy only’’. If any 

30-day period of care consisted of only 

visits for skilled nursing, home health 

aide, or social worker, then this 30-day 

period of care is considered ‘‘no 

therapy’’. If any 30-day period of care 

consisted of at least one therapy visit 

and one non-therapy, then this 30-day 

period of care is considered ‘‘therapy + 

non-therapy’’. Table 10 shows the 

proportion of 30-day periods of care 

with only therapy visits, at least one 

therapy visit and one non-therapy visits, 

and no therapy visits. Figure 3 shows 

the proportion of 30-day periods of care 

by the number of therapy visits 

(excluding zero) provided during 30-day 

periods of care. 

Both Table 10 and Figure 3, as 

previously discussed, indicate there 

have been changes in the distribution of 

both therapy and non-therapy visits in 

CY 2020. For example, the percent of 

30-day periods with six or less therapy 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.011</GPH> EP07JY21.012</GPH>

TABLE 10: PROPORTION OF 30-DAY PERIODS OF CARE WITH ONLY THERAPY, 

AT LEAST ONE THERAPY VISITS, AND NO THERAPY VISIT FOR CY 2018-2020 

30-dav Period Visit Type CY 2018 (Simulated) CY 2019 (Simulated) CY 2020 

Theraov Only 13.5% 14.4% 15.2% 

Therapy+ Non-therapy 48.2% 48.4% 42.2% 

No Theraov 38.3% 37.2% 42.6% 

Total 30-dav periods 9,336,898 8,744,171 8,165,402 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

FIGURE 3: PROPORTION OF 30-DAY PERIODS OF CARE BY THE NUMBER 

OF THERAPY VISITS DURING 30-DAY PERIODS, CYs 2018-2020. 

V, 

"O 

9.0% 

8.0% 

.2 7.0% ... 

(I) 

c.. 6.0% 

2018 • • •· • 2019 --- 2020 

> ,_ 

"9 5.0% 

0 

~ 4.0% 0 

1:: 3.0% (I) 

~ 2.0% Cl.. 1.0%, "'" L • •• h.CC w,,,. C•'-"H ,,ocw. ,c , , s •.--,.,,~--•---- -•••.CS~., _ _,_ •---~••-•• c,• "'''"•, A., ,, " •••-••••• 

1 2 3 4 5 6 7 8 9 10 11 12 13+ 

Number of Therapy Visits During 30-day Periods 

--···· ----~·-'" .... ,, .... ._ .. _,, . ,,. ·- .,.,.,... ··-·--- . __.,_._, ___ -.... --· .. ·--·- .,_. ___ - - - -· -- - - . ·-- - .. -- , -- ... ,, . ., --··-··--····-- ._. '"""'" --·"~'""" ~---_. ____ " __ , ... 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021 and includes all months of data. 

Notes: Thirty-day periods of care with 2:13 therapy visits were combined into one category for illustrative purposes 

only 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35889 

visits during a 30-day period increased 

in CY 2020. However, the percent of 30- 

day periods with seven or more therapy 

visits decreased in CY 2020. 

In addition, we also examined the 

proportion of 30-day periods of care 

with and without skilled nursing, social 

work, or home health aide visits for CYs 

2018, 2019 and 2020. Table 11 shows 

the number of 30-day periods of care 

with only skilled nursing visits, at least 

one skilled nursing visit and one other 

visit type (therapy or non-therapy), and 

no skilled nursing visits. Table 13 

shows the number of 30-day periods of 

care with and without home health aide 

and/or social worker visits. 

We will continue to monitor the 

provision of home health services, 

including any changes in the number 

and duration of home health visits, 

composition of the disciplines 

providing such services, and overall 

home health payments to determine if 

refinements to the case-mix adjustment 

methodology may be needed in the 

future. 

We solicit public comments on the 

preliminary data analysis presented in 

this rule and we solicit comments on 

whether there are other analyses that 

should be conducted to examine the 

effects of the PDGM on home health 

expenditures and utilization. 

2. Comment Solicitation on the Annual 

Determination of the Impact of 

Differences Between Assumed Behavior 

Changes and Actual Behavior Changes 

on Estimated Aggregate Payment 

Expenditures Under the HH PPS 

a. Background 

Section 1895(b)(3)(A)(iv) of the Act, 

required CMS, with respect to payments 

for home health units of service 

furnished that end during the 12-month 

period beginning January 1, 2020, to 

calculate a standard prospective 

payment amount (or amounts) for 30- 

day units of service in a manner such 

that the estimated aggregate amount of 

expenditures would be equal to the 

estimated aggregate amount of 

expenditures that otherwise would have 

been made had the 30-day unit of 

payment not been enacted. In 

calculating such amount (or amounts), 

CMS was required to make assumptions 

about behavior changes that could occur 

as a result of the implementation of the 

30-day unit of payment and the casemix adjustment factors that eliminated 

the use of therapy thresholds. CMS was 

to provide a description of such 

assumptions through notice and 

comment rulemaking. 

In the CY 2019 HH PPS final rule with 

comment period (83 FR 56454), as 

required by law, we stated that this 

means we were required to calculate a 

30-day period payment amount for CY 

2020 in a budget neutral manner such 

that estimated aggregate expenditures 

under the HH PPS during CY 2020 were 

equal to the estimated aggregate 

expenditures that otherwise would have 

been made under the HH PPS during CY 

2020 in the absence of the change to a 

30-day unit of payment and the 

implementation of the PDGM case-mix 

adjustment methodology. This means 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.013</GPH> EP07JY21.014</GPH>

TABLE 11: PROPORTION OF 30-DAY PERIODS OF CARE WITH ONLY 

SKILLED NURSING, SKILLED NURSING+ OTHER VISIT TYPE, AND NO SKILLED 

NURSING VISITS FOR CYs 2018-2020 

30-day Period Visit Type CY 2018 CY 2019 CY 2020 (Simulated) (Simulated) 

Skilled Nursing Only 33.8% 33.1% 38.6% 

Skilled Nursing + Other 51.6% 51.5% 45.2% 

No Skilled Nursing 14.7% 15.5% 16.2% 

Total 30-dav periods 9,336 898 8,744,171 8 165 402 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 

TABLE 12: PROPORTION OF 30-DAY PERIODS OF CARE WITH AND 

WITHOUT HOME HEALTH AIDE AND/OR SOCIAL WORKER VISITS FOR CYs 

2018-2020 

30-day Period Visit Type CY 2018 CY 2019 CY 2020 (Simulated) (Simulated) 

Any HH aide and/or social worker 16.6% 15.9% 13.1% 

No HH aide and/or social worker 83.4% 84.1% 86.9% 

Total 30-day periods 9,336,898 8,744,171 8,165,402 

Source: Analysis of data for CY 2018 through CY 2020. CY 2018 and CY 2019 data came from the Home Health 

LDS file and we applied the three behavioral assumptions to half the claims (randomly selected). CY 2020 was 

accessed from the CCW VRDC on March 30, 2021. 
35890 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

7All of a beneficiary’s claims were dropped so as 

not to create problems with assigning episode 

timing if only a subset of claims were dropped. 

1,320 claims from 224 beneficiaries are excluded. 

8This was done because if three or more claims 

linked to the same OASIS it would not be clear 

which claims should be joined to simulate a 60-day 

episode. 11,794 claims from 351 beneficiaries are 

excluded. 

that aggregate Medicare payments under 

the new 432-group payment system and 

30-day unit of payment would be the 

same as they would have been under the 

153-group payment system and 60-day 

unit of payment. 

In the CY 2019 HH PPS final rule with 

comment period (83 FR 56455), we 

finalized three behavior assumptions in 

order to calculate a 30-day budgetneutral payment amount for CY 2020: 

• Clinical Group Coding: The clinical 

group is determined by the principal 

diagnosis code for the patient as 

reported by the HHA on the home 

health claim. This behavior assumption 

assumes that HHAs will change their 

documentation and coding practices 

and put the highest paying diagnosis 

code as the principal diagnosis code in 

order to have a 30-day period be placed 

into a higher-paying clinical group. 

• Comorbidity Coding: The PDGM 

further adjusts payments based on 

patients’ secondary diagnoses as 

reported by the HHA on the home 

health claim. The OASIS only allows 

HHAs to designate 1 principal diagnosis 

and 5 secondary diagnoses while the 

home health claim allows HHAs to 

designate 1 principal diagnosis and up 

to 24 secondary diagnoses. This 

behavior assumption assumes that by 

taking into account additional ICD–10– 

CM diagnosis codes listed on the home 

health claim (beyond the 6 allowed on 

the OASIS), more 30-day periods of care 

will receive a comorbidity adjustment. 

• LUPA Threshold: This behavior 

assumption assumes that for one-third 

of LUPAs that are 1 to 2 visits away 

from the LUPA threshold HHAs will 

provide 1 to 2 extra visits to receive a 

full 30-day payment. 

There are overlaps and interactions 

between these behavior assumptions, 

and when combined, the budget-neutral 

payment amount for CY 2020 resulted 

in a proposed ¥8.389 percent 

adjustment to the 30-day period 

payment amount compared to the 

payment amount calculated in a budget 

neutral manner without these 

assumptions applied. In response to the 

proposed rule, commenters stated that 

CMS overestimated the magnitude of 

the assumed behavior changes. We 

reconsidered the frequency of the 

assumed behaviors during the first year 

of the transition to the new unit of 

payment and case-mix adjustment 

methodology in response to these 

comments, and in the CY 2020 HH PPS 

final rule with comment period (84 FR 

60519), we finalized a ¥4.36 percent 

behavior assumption adjustment in 

order to calculate a national, 

standardized 30-day base payment rate. 

After applying the wage index budget 

neutrality factor and the home health 

payment update, the CY 2020 30-day 

payment rate was set at $1,864.03, and 

for determining outlier payments the 

fixed-dollar loss (FDL) ratio was set at 

0.56. 

Section 1895(b)(3)(D)(i) of the Act 

requires CMS to annually determine the 

impact of the differences between 

assumed behavior changes and actual 

behavior changes on estimated aggregate 

expenditures beginning with 2020 and 

ending with 2026. In the CY 2020 final 

rule (84 FR 60513), we stated that we 

interpret actual behavior changes to 

encompass both behavior changes that 

were previously outlined, as assumed 

by CMS, and other behavior changes not 

identified at the time that the budget 

neutral 30-day payment for CY 2020 

was determined. As required by 

1895(b)(3)(D)(ii) of the Act, the 

Secretary shall, at a time and in a 

manner determined appropriate, 

through notice and comment 

rulemaking, 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 required by section 

1895(b)(3)(D)(iii) of the Act, the 

Secretary shall, at a time and in a 

manner determined appropriate, 

through notice and comment 

rulemaking, provide for one or more 

temporary increases or decreases 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. 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 such amount for a 

subsequent year. That is, we are 

required to retrospectively determine if 

the 30-day payment amount in CY 2020 

resulted in the same level of estimated 

aggregate expenditures that would have 

been made if the change in the unit of 

payment and the PDGM case-mix 

adjustment methodology had not been 

implemented, and make adjustments to 

the 30-day payment amount 

prospectively, if needed. 

b. Methodology To Determine the 

Difference Between Assumed Versus 

Actual Behavior Changes on Estimated 

Aggregate Expenditures 

Using CY 2020 data (as of March 30, 

2021), the most recent, complete data 

available at the time of this proposed 

rule, we analyzed the impact of the 

differences between assumed behavior 

changes and actual behavior changes on 

estimated aggregate expenditures to 

determine whether a temporary and/or 

a permanent increase or decrease is 

needed to the national, standardized 30- 

day period payment in CY 2022. We 

analyzed data to determine if the CY 

2020 30-day payment amount resulted 

in the same estimated aggregate 

expenditures that would have been paid 

if the PDGM and change in the unit of 

payment had not been implemented. 

To evaluate if whether the 30-day 

budget neutral payment amount for CY 

2020 maintained budget neutrality given 

the change to a 30-day unit of payment 

and the implementation of a new casemix adjustment methodology without 

therapy thresholds was accurate, we 

used actual CY 2020 30-day period 

claims data to simulate 60-day episodes 

and we determined what CY 2020 

payments would have been under the 

153-group case-mix system and 60-day 

unit of payment. To do this, we used the 

steps outlined as follows as detailed in 

this section of this rule. 

The first step in repricing CY 2020 

PDGM claims was to determine which 

30-day periods of care could be grouped 

together to form 60-day episodes of care. 

To facilitate grouping, we made some 

exclusions and assumptions. 

(1) Exclusions 

We limited the sample to 30-day 

periods where the claim occurrence 

code 50 date (representing the OASIS 

assessment date) occurred on or before 

October 31, 2020. This was done to 

ensure the simulated 60-day episodes 

we constructed contained both 30-day 

periods and would not be simulated 60- 

day episodes that would have 

overlapped into 2021. 

We excluded the following: 

• Beneficiaries and all of their claims 

if they had overlapping claims from the 

same provider (as identified by CCN).7

• Beneficiaries and all of their claims 

if three or more claims from the same 

provider are linked to the same 

occurrence code 50 date.8

(2) Assumptions 

We assumed the following: 

• If two 30-day periods of care from 

the same provider reference the same 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35891 

OASIS assessment date (using 

occurrence code 50), and then we 

assume those two 30-day periods of care 

would have been billed as a 60-day 

episode of care under the 153-group 

system. 

• If there are two 30 day-periods of 

care that reference different OASIS 

assessment dates and each of those 

assessment dates is referenced by a 

single 30-day period of care and those 

two 30-day periods of care occur 

together close in time (that is, the from 

date of the later 30-day period of care 

is between 0 to 14 days after the through 

date of the earlier 30-day period of care), 

then we assume those two 30-day 

periods of care also would have been 

billed as a 60-day episode of care under 

the 153-group system. 

• For all other 30-day periods of care, 

we assumed that they would not be 

combined with another 30-day period of 

care and would have been billed alone. 

We excluded such periods that occurred 

at the start of the year (January 1, 2020– 

January 14, 2020) or end of the year 

(December 1–31, 2020) so as not to 

count a single 30-day period of care that 

may have had a counterpart that could 

not be observed. 

Once we applied our exclusions and 

assumptions, we assigned each 60-day 

episode of care as a normal episode, 

PEP, LUPA, or outlier based on the 

payment parameters established in the 

CY 2020 final rule with comment period 

(84 FR 60478) for 60-day episodes of 

care. Next, using the 3M Home Health 

Grouper (v8219) we assigned a Health 

Insurance Prospective Payment System 

(HIPPS) code to each simulated 60-day 

episode of care using the 153-group 

methodology. Finally, we priced out the 

simulated 60-day episodes of care using 

the payment parameters described in 

the CY 2020 final rule with comment 

period (84 FR 60537) for 60-day 

episodes of care. Before comparing 

payments for the 30-day periods of care 

using the 432-group PDGM 

methodology, we first removed any 

claim that was excluded in the 

simulated 60-day episode dataset. 

Therefore, our comparison between 

payments had the same utilization 

between the CY 2020 simulated 60-day 

episodes of care and the CY 2020 actual 

30-day periods of care. 

We began with 8,165,808 30-day 

periods of care and dropped 524,163 30- 

day periods of care that had a claim 

occurrence code 50 date after October 

31, 2020. We also eliminated 81,641 30- 

day periods of care that appeared to not 

group with another 30-day period of 

care to form a 60-day episode of care if 

the 30-day period of care had a ‘‘from 

date’’ before January 15, 2020 or a 

‘‘through date after’’ November 30, 

2020. This was done to ensure the 30- 

day period of care would not have been 

part of a 60-day episode of care that 

would have spanned into a prior or 

subsequent year. As described 

previously, we excluded claims and 

made assumptions when combining two 

30-day periods of care. Additionally, 

any simulated 60-day episode of care 

where no OASIS information was 

available or could not be grouped to a 

HIPPS due to a missing primary 

diagnosis or other reason was excluded 

from analysis. Our simulated 60-day 

episodes of care produced a distribution 

between two 30-day periods of care 

(69.8 percent) and single 30-day periods 

of care (30.2 percent) that was similar to 

what we found when we simulated two 

30-day periods of care for 

implementation of the PDGM. After all 

exclusions and assumptions were 

applied, the final dataset included 

7,441,602 actual 30-day periods of care 

and 4,378,823 simulated 60-day 

episodes of care for CY 2020. 

For the simulated 60-day episodes of 

care and before any adjustment for PEP, 

LUPA, or outliers were applied, 

payments were calculated using the CY 

2020 153-group 60-day base payment 

rate of $3,220.79, the 153-group casemix adjustment methodology, and FDL 

of 0.51, as described in the CY 2020 HH 

PPS final rule with comment period (84 

FR 60537). For the actual 30-day periods 

of care that constructed the simulated 

60-day episodes of care and before any 

adjustment for PEP, LUPA, or outliers 

were applied, payments were calculated 

using the CY 2020 30-day base payment 

rate of $1,864.03, the 432-group PDGM 

case-mix adjustment methodology, and 

FDL of 0.56 as described in the CY 2020 

final rule with comment period (84 FR 

60539). After the claims in the 

simulated 60-day episodes of care and 

30-day periods of care were priced using 

the payment rates described previously, 

we calculated the total payments for all 

periods, normal periods, PEPs, LUPAs, 

and outliers (excluding the base 

payment to ensure outlier payments 

were no more than 2.5 percent of total 

estimated HH PPS payments). Our 

preliminary results indicated that 

aggregate payments to HHAs were 

higher in CY 2020 under the PDGM 

case-mix adjustment methodology and 

the 30-day unit of payment compared to 

what HHAs would have been paid had 

the PDGM and 30-day unit of payment 

not been implemented. 

Next, we calculated what the CY 2020 

30-day periods of care base payment 

rate and FDL should have been, to 

achieve the estimated aggregate 

payments for the simulated 60-day 

episodes in CY 2020. We then 

calculated a percent change between the 

payment rates. In other words, we 

divided the CY 2020 repriced 30-day 

base payment rate by the actual CY 2020 

base-payment rate minus one. We 

determined the CY 2020 30-day base 

payment rate was approximately 6 

percent higher than it should have been, 

and would require temporary 

retrospective adjustments for CY 2020 

and subsequent years until a permanent 

prospective adjustment could be 

implemented in future rulemaking. 

One of the driving factors between 

what we paid HHAs under the current 

432-group PDGM methodology with a 

30-day unit of payment and what we 

would have paid HHAs under the 

previous 153-group case-mix adjustment 

methodology with a 60-day unit of 

payment is related to the average casemix weights. The average case-mix 

weight for the 30-day periods of care 

used to construct the simulated 60-day 

of care episodes was 1.0310; compared 

to the average case-mix weight for the 

simulated 60-day of care episodes was 

0.9657, a difference of 0.0653. As the 

difference between the two average 

case-mix weights increases (that is, 

farther from zero) the higher the 

difference in payments; conversely as 

the difference between the two average 

case-mix weights decreases (that is, 

closer to zero) the smaller the difference 

in payments. HHAs should be providing 

visits in accordance with patient care 

needs. 

The law provides flexibility for the 

Secretary to make an increase or 

decrease adjustment to the 30-day 

payment amount to offset any difference 

between assumed versus actual behavior 

of estimated aggregate expenditures, at a 

time and manner determined 

appropriate and allows for prospective 

adjustments based on retrospective 

behavior. As stated previously, 

currently our preliminary analysis 

shows an additional payment decrease 

would more appropriately account for 

behaviors reflected in CY 2020, after the 

implementation of the PDGM and 30- 

day unit of payment. However, we 

anticipate potentially seeing further 

variability in this percentage as we 

continue to analyze full claims data 

from CY 2020 and subsequent years, 

and considering that the COVID–19 PHE 

is still ongoing. We intend to propose a 

methodology and, if appropriate, a 

temporary and permanent payment 

adjustment based on our analysis in 

future rulemaking. However, we note 

that by not proposing any adjustment 

for CY 2022, this could potentially 

result in larger, compounding payment 

adjustments in future years to fully 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35892 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

9https://www.cms.gov/Center/Provider-Type/ 

Home-Health-Agency-HHA-Center. 

account for the difference between 

assumed versus actual behavior change 

on estimated aggregate expenditures 

beginning in CY 2020. 

We recognize that stakeholders may 

have other ways to analyze the data to 

determine the difference between 

assumed versus actual behavior change 

on estimated aggregate expenditures, 

such as analysis of nominal case-mix 

growth or calculating the percent 

difference and percent change of 

payments between simulated 30-day 

periods of care and actual 30-day 

periods of care. We solicit comments on 

the described repricing method for 

evaluating budget neutrality for CY 2020 

and any alternate approaches to 

annually determine the difference 

between assumed and actual behavioral 

changes on estimated aggregate 

expenditures under the HH PPS. 

3. CY 2022 PDGM LUPA Thresholds 

and PDGM Case-Mix Weights 

a. Proposed CY 2022 PDGM LUPA 

Thresholds 

Under the HH PPS, LUPAs are paid 

when a certain visit threshold for a 

payment group during a 30-day period 

of care is not met. 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 (subject to any PEP or 

outlier adjustments). If a 30-day period 

of care does not meet the PDGM LUPA 

visit threshold, then payment will be 

made using the CY 2022 per-visit 

payment amounts as described in 

Section III 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 we stated in the CY 

2021 final rule (85 FR 70305, 70306) we 

would maintain the LUPA thresholds 

that were finalized and shown in Table 

17 of the CY 2020 HH PPS final rule 

with comment period (84 FR 60522) for 

CY 2021 payment purposes. At that 

time, we did not have sufficient CY 

2020 data to reevaluate the LUPA 

thresholds for CY 2021. 

We have received anecdotal feedback 

from stakeholders that in CY 2020, 

HHAs billed more LUPAs because 

patients requested fewer in-person visits 

due the COVID–19 PHE. As discussed 

further in this section of this rule, while 

we are proposing to update the case-mix 

weights for CY 2022 using CY 2020 

data, there are several factors that 

contribute to how the case-mix weight 

is set for a particular case-mix group 

(such as the number of visits, length of 

visits, types of disciplines providing 

visits, and non-routine supplies) and the 

case-mix weight is derived by 

comparing the average resource use for 

the case-mix group relative to the 

average resource use across all groups. 

CMS believes that the PHE would have 

impacted utilization within all case-mix 

groups similarly. Therefore, the impact 

of any reduction in resource use caused 

by the PHE on the calculation of the 

case-mix weight would be minimized 

since the impact would be accounted for 

both in the numerator and denominator 

of the formula used to calculate the 

case-mix weight. However, in contrast, 

the LUPA thresholds are based on the 

number of overall visits in a particular 

case-mix group (the threshold is the 

10th percentile of visits or 2 visits, 

whichever is greater) instead of a 

relative value (like what is used to 

generate the case-mix weight) that 

would control for the impacts of the 

PHE. We note that visit patterns and 

some of the decrease in overall visits in 

CY 2020 may not be representative of 

visit patterns in CY 2022. If we were to 

set the LUPA thresholds in this 

proposed rule using CY 2020 data and 

then set the LUPA thresholds again for 

CY 2023 using data from CY 2021, it is 

likely that there would be an increase in 

these thresholds due to the lower 

number of visits that occurred in CY 

2020. Therefore, to mitigate any 

potential future and significant shortterm variability in the LUPA thresholds 

due to the COVID–19 PHE, we are 

proposing to maintain the LUPA 

thresholds finalized and displayed in 

Table 17 in the CY 2020 HH PPS final 

rule with comment period (84 FR 

60522) for CY 2022 payment purposes. 

We believe that maintaining the LUPA 

thresholds for CY 2022 is the best 

approach because it mitigates potential 

fluctuations in the thresholds caused by 

visit patterns changing from what we 

observed in CY 2020 potentially due to 

the PHE. We will repost these LUPA 

thresholds (along with the case-mix 

weights) that will be used for CY 2022 

on the HHA Center web page.9 We 

solicit public comments on maintaining 

the LUPA thresholds for CY 2022 

payment purposes. 

b. CY 2022 Functional Impairment 

Levels 

Under the PDGM, the functional 

impairment level is determined by 

responses to certain OASIS items 

associated with activities of daily living 

and risk of hospitalization; that is, 

responses to OASIS items M1800– 

M1860 and M1032. A home health 

period of care receives points based on 

each of the responses associated with 

these functional OASIS items, which are 

then converted into a table of points 

corresponding to increased resource 

use. The sum of all of these points 

results in a functional score which is 

used to group home health periods into 

a functional level with similar resource 

use. That is, the higher the points, the 

higher the response is associated with 

increased resource use. The sum of all 

of these points results in a functional 

impairment score which is used to 

group home health periods into one of 

three functional impairment levels with 

similar resource use. The three 

functional impairment levels of low, 

medium, and high were designed so that 

approximately one-third of home health 

periods from each of the clinical groups 

fall within each level. This means home 

health periods in the low impairment 

level have responses for the functional 

OASIS items that are associated with 

the lowest resource use, on average. 

Home health periods in the high 

impairment level have responses for the 

functional OASIS items that are 

associated with the highest resource use 

on average. 

For CY 2022, we propose to use CY 

2020 claims data to update the 

functional points and functional 

impairment levels by clinical group. 

The CY 2018 HH PPS Proposed rule (82 

FR 35320) and the HHGM technical 

report from December 2016 posted on 

the HHA Center web page provide a 

more detailed explanation as to the 

construction of these functional 

impairment levels using the OASIS 

items. We are proposing to use this 

same methodology previously finalized 

to update the functional impairment 

levels for CY 2022. The updated OASIS 

functional points table and the table of 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35893 

functional impairment levels by clinical 

group for CY 2022 are listed in Tables 

13 and 14, respectively. We solicit 

public comments on the updates to functional points and the functional 

impairment levels by clinical group. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.015</GPH>

TABLE 13: OASIS POINTS TABLE FOR THOSE ITEMS ASSOCIATED WITH 

INCREASED RESOURCE USE USING A REDUCED SET OF OASIS ITEMS, CY 2020 

Percent of Periods 

in 2020 with this 

Points Response 

Resnonses (2020) Cate2orv 

M1800: Grooming 0 or 1 0 33.8% 

2 or 3 3 66.2% 

M1810: Current Ability to Dress Upper Body 0 or 1 0 28.8% 

2 or 3 6 71.2% 

0 or 1 0 13.6% 

M1820: Current Ability to Dress Lower Body 2 5 63.3% 

3 12 23.0% 

0 or 1 0 3.4% 

M1830: Bathing 2 1 13.4% 

3 or4 9 51.4% 

5 or6 17 31.7% 

M1840: Toilet Transferring 0 or 1 0 63.7% 

2 3 or4 5 36.3% 

0 0 2.0% 

M1850: Transferring 1 3 24.3% 

2. 3 4 or 5 7 73.7% 

0 or 1 0 4.5% 

M1860: Ambulation/Locomotion 2 6 16.8% 

3 6 61.2% 

4 5 or6 19 17.5% 

Three or fewer items 

marked (Excluding 

M1032: Risk of Hospitalization responses 8 9 or 10) 0 70.1% 

Four or more items 

marked (Excluding 

responses 8, 9 or 10) 12 29.9% 

Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed from the CCW on March 30, 

2021. 
35894 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

c. CY 2022 Comorbidity Subgroups 

Thirty-day periods of care receive a 

comorbidity adjustment category based 

on the presence of certain secondary 

diagnoses reported on home health 

claims. These diagnoses are based on a 

home-health specific list of clinically 

and statistically significant secondary 

diagnosis subgroups with similar 

resource use, meaning the diagnoses 

have at least as high as the median 

resource use and are reported in more 

than 0.1 percent of 30-day periods of 

care. Home health 30-day periods of 

care can receive a comorbidity 

adjustment under the following 

circumstances: 

• Low comorbidity adjustment: There 

is a reported secondary diagnosis on the 

home health-specific comorbidity 

subgroup list that is associated with 

higher resource use. 

• High comorbidity adjustment: 

There are two or more secondary 

diagnoses on the home health-specific 

comorbidity subgroup interaction list 

that are associated with higher resource 

use when both are reported together 

compared to if they were reported 

separately. That is, the two diagnoses 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.016</GPH>

TABLE 14: THRESHOLDS FOR FUNCTIONAL LEVELS BY CLINICAL GROUP, 

CY 2020 

Level of Points 

Clinical Group Impairment (2020) 

Low 0-32 

MMTA-Other Medium 33-48 

High 49+ 

Low 0-32 

Behavioral Health Medium 33-48 

High 49+ 

Low 0-35 

Complex Nursing Interventions Medium 36-56 

High 57+ 

Low 0-35 

Musculoskeletal Rehabilitation Medium 36-48 

High 49+ 

Low 0-36 

Neuro Rehabilitation Medium 37-55 

High 56+ 

Low 0-36 

Wound Medium 37-53 

High 54+ 

Low 0-33 

MMTA - Surgical Aftercare Medium 34-45 

High 46+ 

Low 0-32 

MMTA - Cardiac and Circulatory Medium 33-47 

High 48+ 

Low 0-30 

MMTA - Endocrine Medium 31-44 

High 45+ 

Low 0-36 

MMTA - Gastrointestinal tract and Genitourinary system Medium 37-51 

High 52+ 

MMTA - Infectious Disease, Neoplasms, and Blood-Forming Low 0-33 

Medium 34-48 Diseases High 49+ 

Low 0-36 

MMTA - Respiratory Medium 37-48 

High 49+ 

Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed on the CCW March 

30, 2021. 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35895 

may interact with one another, resulting 

in higher resource use. 

• No comorbidity adjustment: A 30- 

day period of care receives no 

comorbidity adjustment if no secondary 

diagnoses exist or none meet the criteria 

for a low or high comorbidity 

adjustment. 

In the CY 2019 HH PPS final rule with 

comment period (83 FR 56406) we 

stated that we would continue to 

examine the relationship of reported 

comorbidities on resource utilization 

and make the appropriate payment 

refinements to help ensure that payment 

is in alignment with the actual costs of 

providing care. For CY 2022, we 

propose to use the same methodology 

used to establish the comorbidity 

subgroups to update the comorbidity 

subgroups using CY 2020 home health 

data. 

For CY 2022, we propose to update 

the comorbidity subgroups to include 20 

low comorbidity adjustment subgroups 

as identified in Table 15 and 85 high 

comorbidity adjustment interaction 

subgroups as identified in Table 16. The 

proposed CY 2022 low comorbidity 

adjustment subgroups and the high 

comorbidity adjustment interaction 

subgroups including those diagnoses 

within each of these comorbidity 

adjustments will also be posted on the 

HHA Center web page at https://

www.cms.gov/Center/Provider-Type/ 

Home-Health-Agency-HHA-Center. 

We invite comments on the proposed 

updates to the low comorbidity 

adjustment subgroups and the high 

comorbidity adjustment interactions for 

CY 2022. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.017</GPH> EP07JY21.018</GPH>

TABLE 15: LOW COMORBIDITY ADJUSTMENT SUBGROUPS FOR CY 2022 

Low Comorbidity Sub2roup Sub2roup Description 

Neoplasms 22 Includes lymphoma and leukemia 

Musculoskeletal 2 Includes rheumatoid arthritis 

Circulatory 7 Includes atherosclerosis and peripheral vascular disease 

Neoplasms 2 Includes gastrointestinal cancers 

Musculoskeletal 1 Includes lupus 

Endocrine 4 Includes malnutrition and graft-versus-host-disease 

Heart 10 Includes atrial fibrillation and atrial flutter. 

Heart 11 Includes heart failure 

Neurological IO Includes diabetes with neuropathv 

Neurological I I Includes macular degeneration 

Neoplasms 18 Includes secondary cancers 

Neoplasms 1 Includes head and neck cancers 

Circulatory 9 Includes embolisms and thromboses 

Cerebral 4 Includes cerebral atherosclerosis and stroke sequelae 

Skin 1 Includes cellulitis and abscesses 

Neurological 5 Includes Parkinson's Disease 

Circulatory 10 Includes varicose veins with ulceration 

Neurological 7 Includes paraplegia. hemiplegia and auadriplegia 

Skin 3 Includes chronic ulcers 

Skin 4 Includes pressure ulcers 

Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed on the CCW March 

30, 2021. 

TABLE 16: HIGH COMORBIDITY ADJUSTMENT INTERACTIONS FOR CY 2022 

Comorbidity Subgroup Comorbidity Comorbidity 

Interaction Group Group 

1 Neurological 4 Respiratory 9 

2 Neurological 4 Neurological 5 

3 Renal I Skin 3 

4 Behavioral 2 Neurological 5 

5 Cerebral 4 Neurological IO 

6 Endocrine 3 Neurological 5 

7 Neurological 3 Skin 3 

8 Endocrine 5 neurological 7 
35896 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.019</GPH>

Comorbidity Subgroup Comorbidity Comorbidity 

Interaction Group Group 

9 Neurological 10 Neurological 5 

10 Musculoskeletal 3 Neurological 7 

11 Heart 12 Skin 3 

12 Circulatorv 9 Endocrine 4 

13 Circulatorv 4 Neurological 7 

14 Circulatorv 2 Neurological 5 

15 Neurological 4 Skin 3 

16 Cerebral 4 Neurological 5 

17 Heart 11 Neurological 7 

18 N curological 5 Neurological 7 

19 Circulatorv 10 Heart 11 

20 Circulatorv 10 Endocrine 5 

21 Circulatorv 4 Skin 3 

22 Neurological 10 Skin 3 

23 Skin 1 Skin3 

24 Endocrine I Skin 3 

25 Cerebral 4 Skin 3 

26 Neurological 7 Renal 3 

27 Musculoskeletal 4 Skin3 

28 Musculoskclctal 3 Skin3 

29 Heart 8 Skin3 

30 Circulatorv 1 Neurological 7 

31 Circulatorv 7 Skin 3 

32 Endocrine 3 Skin 3 

33 Endocrine 5 Skin 3 

34 Neurological 3 Skin 4 

35 Circulatorv 2 Neurological 7 

36 Endocrine 4 Neurological 7 

37 Renal 1 Skin4 

38 Cerebral 4 Skin4 

39 Circulatorv 10 Skin 3 

40 Infectious 1 Skin4 

41 Renal 3 Skin4 

42 Heart 10 Skin4 

43 Endocrine 4 Skin4 

44 Neurological 7 Skin4 

45 Skin 3 Skin4 

46 Cerebral 4 Circulatory 7 

47 Circulatorv 9 Renal 3 

48 Circulatorv 10 Endocrine 3 

49 Circulatorv 10 Heart 12 

50 Behavioral 2 Neurological 7 

51 Neurolo_gical 5 Skin 3 

52 Neurolo_gical 4 Skin4 

53 Endocrine 5 Skin 1 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35897 

BILLING CODE 4120–01–C 

d. CY 2022 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 home 

health resource groups (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 with the most recent and 

complete utilization data available at 

the time of annual rulemaking. Annual 

recalibration of the PDGM case-mix 

weights ensures that the case-mix 

weights reflect, as accurately as 

possible, current home health resource 

use and changes in utilization patterns. 

To generate the proposed recalibrated 

CY 2022 case-mix weights, we used CY 

2020 home health claims data with 

linked OASIS data (as of March 30, 

2021). These data are the most current 

and complete data available at this time. 

We believe that recalibrating the casemix weights using data from CY 2020 

would be more reflective of PDGM 

utilization and patient resource use than 

case-mix weights that were set using 

simulated claims data of 60-day 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.020</GPH>

Comorbidity Subgroup Comorbidity Comorbidity 

Interaction Group Group 

54 Neurological 5 Renal 3 

55 Cerebral 4 Heart 11 

56 Infectious 1 Skin 3 

57 Respiratory 5 Skin4 

58 Endocrine 1 Skin 4 

59 Circulatory 10 Neurological 10 

60 Circulatory 1 Skin 3 

61 Musculoskeletal 2 Skin 3 

62 Respiratory 4 Skin 3 

63 Neurological 11 Skin 4 

64 Behavioral 2 Skin 4 

65 Circulatory 1 Neurological 5 

66 Neurological 10 Skin 4 

67 Heart 11 Skin 3 

68 Resoiratory 9 Skin 3 

69 Circulatory 2 Skin 4 

70 Cerebral 4 Circulatory 2 

71 Circulatory 10 Endocrine 1 

72 Heart 11 Skin 1 

73 Circulatory 10 Neurological 11 

74 Endocrine 5 Neurological 5 

75 Musculoskeletal 3 Neurological 5 

76 Heart 10 Skin 3 

77 Behavioral 5 Skin 4 

78 Circulatory 7 Neurological 5 

79 Heart 10 Skin 1 

80 Circulatory 10 Respiratory 5 

81 Behavioral 5 Neurological 7 

82 Musculoskeletal 4 Neurological 5 

83 Neurological 11 Skin 1 

84 Circulatory 9 Neurological 10 

85 Circulatory 4 Skin 4 

Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed from 

the CCW March 30, 2021. 
35898 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

episodes grouped under the old system. 

Using data from CY 2020 would begin 

to shift case-mix weights derived from 

data with 60-day episodes grouped 

under the old system to data from actual 

30-day periods under the PDGM. 

The claims data provide visit-level 

data and data on whether NRS was 

provided during the period and the total 

charges of NRS. We determine the casemix weight for each of the 432 different 

PDGM payment groups by regressing 

resource use on a series of indicator 

variables for each of the categories using 

a fixed effects model as described in the 

following steps: 

Step 1: Estimate a regression model to 

assign a functional impairment level to 

each 30-day period. The regression 

model estimates the relationship 

between a 30-day period’s resource use 

and the functional status and risk of 

hospitalization items included in the 

PDGM, which are obtained from certain 

OASIS items. We refer readers to Table 

11 for further information on the OASIS 

items used for the functional 

impairment level under the PDGM. We 

measure resource use with the cost-perminute + NRS approach that uses 

information from 2019 home health cost 

reports. We use 2019 home health cost 

report data because it is the most 

complete data available at the time of 

rulemaking. Other variables in the 

regression model include the 30-day 

period’s admission source, clinical 

group, and 30-day period timing. We 

also include home health agency level 

fixed effects in the regression model. 

After estimating the regression model 

using 30-day periods, we divide the 

coefficients that correspond to the 

functional status and risk of 

hospitalization items by 10 and round to 

the nearest whole number. Those 

rounded numbers are used to compute 

a functional score for each 30-day 

period by summing together the 

rounded numbers for the functional 

status and risk of hospitalization items 

that are applicable to each 30-day 

period. Next, each 30-day period is 

assigned to a functional impairment 

level (low, medium, or high) depending 

on the 30-day period’s total functional 

score. Each clinical group has a separate 

set of functional thresholds used to 

assign 30-day periods into a low, 

medium or high functional impairment 

level. We set those thresholds so that we 

assign roughly a third of 30-day periods 

within each clinical group to each 

functional impairment level (low, 

medium, or high). 

Step 2: A second regression model 

estimates the relationship between a 30- 

day period’s resource use and indicator 

variables for the presence of any of the 

comorbidities and comorbidity 

interactions that were originally 

examined for inclusion in the PDGM. 

Like the first regression model, this 

model also includes home health agency 

level fixed effects and includes control 

variables for each 30-day period’s 

admission source, clinical group, 

timing, and functional impairment 

level. After we estimate the model, we 

assign comorbidities to the low 

comorbidity adjustment if any 

comorbidities have a coefficient that is 

statistically significant (p-value of 0.05 

or less) and which have a coefficient 

that is larger than the 50th percentile of 

positive and statistically significant 

comorbidity coefficients. If two 

comorbidities in the model and their 

interaction term have coefficients that 

sum together to exceed $150 and the 

interaction term is statistically 

significant (p-value of 0.05 or less), we 

assign the two comorbidities together to 

the high comorbidity adjustment. 

Step 3: Hold the LUPA thresholds at 

their current thresholds as described 

previously in this proposed rule. 

Step 4: Take all non-LUPA 30-day 

periods and regress resource use on the 

30-day period’s clinical group, 

admission source category, episode 

timing category, functional impairment 

level, and comorbidity adjustment 

category. The regression includes fixed 

effects at the level of the home health 

agency. After we estimate the model, the 

model coefficients are used to predict 

each 30-day period’s resource use. To 

create the case-mix weight for each 30- 

day period, the predicted resource use 

is divided by the overall resource use of 

the 30-day periods used to estimate the 

regression. 

The case-mix weight is then used to 

adjust the base payment rate to 

determine each 30-day period’s 

payment. Table 17 shows the 

coefficients of the payment regression 

used to generate the weights, and the 

coefficients divided by average resource 

use. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35899 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.021</GPH>

TABLE 17: COEFFICIENT OF PAYMENT REGRESSION AND COEFFICIENT 

DIVIDED BY A VERA GE RESOURCE USE 

(LUPA THRESHOLDS HELD) 

Coefficient 

Percentage Divided by 

of30-Day Average 

Periods for Resource 

Variable Coefficient this Model Use 

Clinical Group and Functional Impairment Level lMMTA - Other - Low is excluded) 

MMTA - Other - Mediwn FW1ctional $168.75 1.2% 0.1173 

MMTA - Other - High FW1ctional $328.92 0.9% 0.2286 

MMTA - S=ical Aftercare - Low FW1ctional -$84.68 1.2% -0.0589 

MMTA - Surgical Aftercare - Mediwn FW1ctional $136.53 1.2% 0.0949 

MMTA - Surgical Aftercare - High FW1ctional $373.88 1.1% 0.2598 

MMTA - Cardiac and Circulatorv - Low FW1ctional -$46.28 6.8% -0.0322 

MMTA - Cardiac and Circulatorv - Mediwn FW1ctional $133.00 6.0% 0.0924 

MMTA - Cardiac and Circulatorv - High FW1ctional $287.68 6.5% 0.1999 

MMTA - Endocrine - Low FW1ctional $283.93 2.5% 0.1973 

MMTA - Endocrine - Mediwn FW1ctional $453.61 2.5% 0.3153 

MMTA - Endocrine - High FW1ctional $560.18 2.4% 0.3893 

MMTA - Gastrointestinal tract and Genitourinarv system - Low FW1ctional -$71.18 1.8% -0.0495 

MMTA - Gastrointestinal tract and Genitourinarv system - Mediwn FW1ctional $129.27 1.3% 0.0898 

MMTA - Gastrointestinal tract and Genitourinarv system - High FW1ctional $259.89 1.5% 0.1806 

MMTA - Infectious Disease, Neoplasms, and Blood-Forming Diseases - Low FW1ctional -$44.92 1.6% -0.0312 

MMTA - Infectious Disease Neoplasms, and Blood-Forming Diseases - Mediwn FW1ctional $130.02 1.7% 0.0904 

MMTA - Infectious Disease Neoplasms, and Blood-Forming Diseases - High FW1ctional $319.67 1.5% 0.2222 

MMTA - Respiratory - Low FW1ctional -$33.98 3.3% -0.0236 

MMTA - Respiratory - Mediwn FW1ctional $132.20 1.9% 0.0919 

MMTA - Respiratory - High FW1ctional $283.71 2.5% 0.1972 

Behavioral Health - Low FW1ctional -$117.70 0.8% -0.0818 

Behavioral Health - Mediwn FW1ctional $109.77 0.8% 0.0763 

Behavioral Health - High FW1ctional $235.73 0.7% 0.1638 

Complex - Low FW1ctional -$125.82 1.0% -0.0874 

Complex - Mediwn FW1ctional $76.72 1.1% 0.0533 

Complex - High FW1ctional $49.15 1.0% 0.0342 

MS Rehab - Low FW1ctional $103.23 6.6% 0.0717 

MS Rehab - Mediwn FW1ctional $253.23 6.9% 0.1760 

MS Rehab - High FW1ctional $485.44 6.0% 0.3374 

Neuro - Low FW1ctional $260.97 3.6% 0.1814 

Neuro - Mediwn FW1ctional $452.77 3.4% 0.3147 

Neuro - High FW1ctional $628.16 3.5% 0.4366 

WoWld - Low FW1ctional $426.01 5.7% 0.2961 

WoWld - Mediwn FW1ctional $597.58 3.8% 0.4153 

WoWld - High FW1ctional $770.94 4.8% 0.5358 

Admission Source with Timine: (Communitv Earlv is excluded) 

CommW1ity - Late -$568.10 62.9% -0.3948 

Institutional - Early $308.04 19.4% 0.2141 

Institutional - Late $173.03 6.1% 0.1203 

Comorbidity Adjustment (No Comorbidity Adjustment is excluded) 

Comorbidity Adjustment - Has at least one comorbidity from comorbidity list, no interaction 

from interaction list $92.90 48.1% 0.0646 

Comorbidity Adjustment - Has at least one interaction from interaction list $318.97 14.6% 0.2217 

Constant $1,365.18 

Average Resource Use $1,438.86 

Nwnber of 30-day Periods 7,365,743 

Adjusted R-Squared 0.3311 

Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed on the CCW March 30, 2021. 
35900 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

10HHA Center web page: https://www.cms.gov/ 

Center/Provider-Type/Home-Health-Agency-HHACenter 

The case-mix weights proposed for 

CY 2022 are listed in Table 19 and will 

also be posted on the HHA Center web 

page 10 upon display of this proposed 

rule. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.022</GPH>

TABLE 18-CASE MIX WEIGHTS FOR EACH HHRG PAYMENT GROUP 

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

lAAll MMT A - Other - Low Early - Community 0 0.9488 

1AA21 MMT A - Other - Low Early - Community 1 1.0134 

1AA31 MMTA - Other - Low Early - Community 2 1.1705 

lABll MMT A - Other - Medium Early - Community 0 1.0661 

1AB21 MMTA - Other - Medium Early - Community 1 1.1306 

1AB31 MMT A - Other - Medium Early - Community 2 1.2877 

lACll MMTA - Other - High Early - Community 0 1.1774 

1AC21 MMT A - Other - High Early - Community 1 1.2420 

1AC31 MMTA - Other - High Early - Community 2 1.3991 

lBAll Neuro-Low Early - Community 0 1.1302 

1BA21 Neuro-Low Early - Community 1 1.1947 

1BA31 Neuro-Low Early - Community 2 1.3518 

lBBll Neuro - Medium Early - Community 0 1.2635 

1BB21 Neuro - Medium Early - Community 1 1.3280 

1BB31 Neuro - Medium Early - Community 2 1.4851 

lBCll Neuro-High Early - Community 0 1.3854 

1BC21 Neuro-High Early - Community 1 1.4499 

1BC31 Neuro-High Early - Community 2 1.6070 

lCAll Wound-Low Early - Community 0 1.2449 

1CA21 Wound-Low Early - Community 1 1.3094 

1CA31 Wound-Low Early - Community 2 1.4665 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35901 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.023</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

lCBll Wound - Medium Earlv - Community 0 1.3641 

1CB21 Wound - Medium Earlv - Community 1 1.4287 

1CB31 Wound - Medium Earlv - Community 2 1.5858 

lCCll Wound - High Earlv - Conununilv 0 1.4846 

1CC21 Wound-High Earlv - Community 1 1.5492 

1CC31 Wound-High Earlv - Community 2 1.7063 

lDAll Complex - Low Earlv - Community 0 0.8613 

1DA21 Complex - Low Earlv - Community 1 0.9259 

IDA31 Complex - Low Earlv - Community 2 1.0830 

lDBll Complex - Medium Earlv - Community 0 1.0021 

1DB21 Complex - Medium Earlv - Community 1 1.0667 

1DB31 Complex - Medium Earlv - Community 2 1.2238 

lDCll Complex - High Earlv - Community 0 0.9829 

1DC21 Complex - High Earlv - Community 1 1.0475 

1DC31 Complex - High Earlv - Community 2 1.2046 

lEAll MS Rehab - Low Earlv - Community 0 1.0205 

1EA21 MS Rehab - Low Earlv - Conununilv 1 1.0851 

1EA31 MS Rehab - Low Earlv - Community 2 1.2422 

lEBll MS Rehab - Medium Earlv - Community 0 1.1248 

1EB21 MS Rehab - Medium Earlv - Community 1 1.1894 

1EB31 MS Rehab - Medium Earlv - Community 2 1.3465 

lECll MS Rehab - High Earlv - Community 0 1.2862 

1EC21 MS Rehab - High Earlv - Community l 1.3507 

1EC31 MS Rehab - High Earlv - Community 2 1.5078 

lFAll Behavioral Health - Low Earlv - Community 0 0.8670 

1FA21 Behavioral Health - Low Earlv - Community 1 0.9316 

1FA31 Behavioral Health - Low Earlv - Community 2 1.0887 

lFBll Behavioral Health - Medium Earlv - Community 0 1.0251 

1FB21 Behavioral Health - Medium Earlv - Community 1 1.0896 

1FB31 Behavioral Health - Medium Earlv - Conununilv 2 1.2468 

lFCll Behavioral Health - High Earlv - Community 0 1.1126 

1FC21 Behavioral Health - High Earlv - Community 1 1.1772 

1FC31 Behavioral Health - High Earlv - Community 2 1.3343 

lGAll MMTA - Surgical Aftercare - Low Earlv - Community 0 0.8899 

IGA21 MMT A - Surgical Aftercare - Low Earlv - Community l 0.9545 

1GA31 MMT A - Surgical Aftercare - Low Earlv - Community 2 1.1116 

lGBll MMT A - Surgical Aftercare - Medium Earlv - Community 0 1.0437 

1GB21 MMT A - Surgical Aftercare - Medium Earlv - Community 1 1.1082 

1GB31 MMT A - Surgical Aftercare - Medium Earlv - Community 2 1.2654 

lGCll MMTA - Surgical Aftercare - High Earlv - Community 0 1.2086 

1GC21 MMTA - Surgical Aftercare - High Earlv - Community 1 1.2732 

1GC31 MMTA - Surgical Aftercare - High Earlv - Community 2 1.4303 

lHAll MMTA - Cardiac - Low Earlv - Conununilv 0 0.9166 

1HA21 J\1MTA - Cardiac - Low Earlv - Community 1 0.9812 

1HA31 J\1MTA - Cardiac - Low Earlv - Community 2 1.1383 

lHBll MMTA - Cardiac - Medium Earlv - Community 0 1.0412 

lHB21 MMTA - Cardiac - Medium Earlv - Community l 1.1058 

IHB31 MMT A - Cardiac - Medium Earlv - Community 2 1.2629 

lHCll MMTA - Cardiac - High Earlv - Community 0 1.1487 

1HC21 MMTA - Cardiac - High Earlv - Community 1 1.2133 

1HC31 MMTA - Cardiac - High Earlv - Community 2 1.3704 

lIAll MMT A - Endocrine - Low Earlv - Community 0 1.1461 

1IA21 MMT A - Endocrine - Low Earlv - Community 1 1.2107 
35902 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.024</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

1IA31 MMT A - Endocrine - Low Early - Communitv 2 1.3678 

11B11 MMT A - Endocrine - Medium Early - Communitv 0 1.2640 

11B21 MMT A - Endocrine - Medium Early - Community 1 1.3286 

11B31 MMT A - Endocrine - Medium Earlv - Connnunitv 2 1.4857 

lICll MMT A - Endocrine - High Early - Communitv 0 1.3381 

1IC21 MMT A - Endocrine - High Early - Communitv 1 1.4027 

1IC31 MMT A - Endocrine - High Early - Communitv 2 1.5598 

lJAll MMTA - Gl/GU - Low Early - Communitv 0 0.8993 

IJA21 MMT A - GT/GU - Low Early - Communitv l 0.9639 

1JA31 MMT A - GI/GU - Low Early - Communitv 2 1.1210 

lJBll MMT A - GI/GU - Medium Early - Communitv 0 1.0386 

1JB21 MMT A - GI/GU - Medium Early - Communitv 1 1.1032 

1JB31 MMT A - GI/GU - Medium Early - Communitv 2 1.2603 

lJCll MMTA - GI/GU - High Early - Communitv 0 1.1294 

1JC21 MMTA - GI/GU - High Early - Community 1 1.1940 

1JC31 MMTA - GI/GU - High Early - Communitv 2 1.3511 

lKAll MMT A - Infectious - Low Earlv - Connnunitv 0 0.9176 

1KA21 MMT A - Infectious - Low Early - Commun.itv 1 0.9821 

1KA31 MMT A - Infectious - Low Early - Communitv 2 1.1393 

lKBll MMT A - Infectious - Medium Early - Communitv 0 1.0392 

lK.821 MMT A - Infectious - Medium Early - Communitv 1 1.1037 

1KB31 MMTA - Infectious - Medium Early - Communitv 2 1.2608 

lKCll MMT A - Infectious - High Early - Communitv 0 1.1710 

1KC21 MMT A - Infectious - High Early - Communitv 1 1.2355 

1KC31 MMT A - Infectious - High Early - Communitv 2 1.3926 

lLAll MMT A - Respiratorv - Low Early - Communitv 0 0.9252 

1LA21 MMT A - Resoiratorv - Low Early - Communitv 1 0.9897 

1LA31 MMT A - Respiratory - Low Early - Community 2 1.1469 

lLBll MMT A - Resoiratorv - Medium Early - Communitv 0 1.0407 

1LB21 MMT A - Respiratorv - Medium Earlv - Connnunitv 1 1.1052 

1LB31 MMT A - Respiratory - Medium Early - Communitv 2 1.2623 

lLCll MMT A - Respiratorv - High Early - Communitv 0 1.1460 

1LC21 MMT A - Respiratory - High Early - Communitv 1 1.2105 

1LC31 MMT A - Respiratorv - High Early - Communitv 2 1.3676 

2AA11 MMT A - Other - Low Early - Institutional 0 1.1629 

2AA21 MMT A - Other - Low Early - Institutional l 1.2274 

2AA31 MMT A - Other - Low Early - Institutional 2 1.3846 

2AB11 MMT A - Other - Medium Early - Institutional 0 1.2802 

2AB21 MMT A - Other - Medium Early - Institutional 1 1.3447 

2AB31 MMT A - Other - Medium Early - Institutional 2 1.5018 

2AC11 MMT A - Other - High Early - Institutional 0 1.3915 

2AC21 MMT A - Other - High Early - Institutional 1 1.4560 

2AC31 MMT A - Other - High Earlv - Institutional 2 1.6132 

2BA11 Neuro -Low Early - Institutional 0 1.3442 

2BA21 Neuro -Low Early - Institutional 1 1.4088 

2BA31 Neuro -Low Early - Institutional 2 1.5659 

28B11 Neuro - Medium Early - Institutional 0 l.4775 

2BB21 Neuro - Medium Early - Institutional I 1.5421 

2BB31 Ncuro - Medium Early - Institutional 2 1.6992 

2BC11 Neuro -High Early - Institutional 0 1.5994 

2BC21 Neuro -High Early - Institutional 1 1.6640 

2BC31 Neuro -High Early - Institutional 2 1.8211 

2CA11 Wound-Low Early - Institutional 0 1.4589 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35903 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.025</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

2CA21 Wound-Low Earlv - Institutional 1 1.5235 

2CA31 Wound-Low Earlv - Institutional 2 1.6806 

2CB11 Wound - Medium Earlv - Institutional 0 1.5782 

2CB21 Wound-Medium Earlv - Institutional 1 1.6428 

2CB31 Wound - Medium Earlv - Institutional 2 1.7999 

2CC11 Wound-High Earlv - Institutional 0 1.6987 

2CC21 Wmmd-High Earlv - Institutional 1 1.7632 

2CC31 Wound -High Earlv - institutional 2 1.9204 

2DA11 Complex - Low Earlv - Institutional 0 1.0754 

2DA2i Complex - Low Earlv - Institutional i 1.1400 

2DA31 Complex - Low Earlv - Institutional 2 1.2971 

2DB11 Complex - Medium Earlv - Institutional 0 1.2162 

2DB21 Complex - Medium Earlv - Institutional 1 1.2808 

2DB31 Complex - Medium Earlv - Institutional 2 1.4379 

2DC11 Complex - High Earlv - Institutional 0 1.1970 

2DC21 Complex - High Earlv - Institutional 1 1.2616 

2DC31 Complex - High Earlv - Institutional 2 1.4187 

2EA11 MS Rehab - Low Earlv - Institutional 0 1.2346 

2EA21 MS Rehab - Low Earlv - Institutional 1 1.2992 

2EA31 MS Rehab - Low Earlv - Institutional 2 1.4563 

2EB11 MS Rehab - Medium Earlv - institutional 0 1.3389 

2EB2l MS Rehab - Medium Earlv - Institutional l 1.4034 

2EB3i MS Rehab - Medium Earlv - Institutional 2 1.5605 

2EC11 MS Rehab - High Earlv - Institutional 0 1.5002 

2EC21 MS Rehab - High Earlv - Institutional 1 1.5648 

2EC31 MS Rehab - High Earlv - Institutional 2 1.7219 

2FA11 Behavioral Health - Low Earlv - Institutional 0 1.0811 

2FA21 Behavioral Health - Low Earlv - Institutional 1 1.1456 

2FA31 Behavioral Health - Low Earlv - Institutional 2 1.3028 

2FB11 Behavioral Health - Medium Earlv - Institutional 0 1.2392 

2FB21 Behavioral Health - Medium Earlv - Institutional 1 1.3037 

2FB31 Behavioral Health - Medium Earlv - Institutional 2 1.4608 

2FC11 Behavioral Health - High Earlv - Institutional 0 1.3267 

2FC21 Behavioral Health - High Earlv - institutional 1 1.3913 

2FC3l Behavioral Health - High Earlv - Institutional 2 1.5484 

2GAii MMT A - Surgical Aftercare - Low Earlv - Institutional 0 1.1040 

2GA21 MMT A - Surgical Aftercare - Low Earlv - Institutional 1 1.1686 

2GA31 MMT A - Surgical Aftercare - Low Earlv - Institutional 2 1.3257 

2GB11 MMT A - Surgical Aftercare - Medium Earlv - Institutional 0 1.2578 

2GB21 MMT A - Surgical Aftercare - Medium Earlv - Institutional 1 1.3223 

2GB31 MMT A - Surgical Aftercare - Medium Earlv - Institutional 2 1.4794 

2GC11 MMTA - Surgical Aftercare - High Earlv - Institutional 0 1.4227 

2GC21 MMT A - Surgical Aftercare - High Earlv - Institutional 1 1.4873 

2GC31 MMT A - Surgical Aftercare - High Earlv - Institutional 2 1.6444 

2HA11 MMTA - Cardiac -Low Earlv - Institutional 0 1.1307 

2HA21 MMTA - Cardiac - Low Earlv - institutional 1 1.1953 

2HA31 MMTA - Cardiac - Low Earlv - Institutional 2 1.3524 

2HBII MMT A - Cardiac - Medium Earlv - Institutional 0 1.2553 

2HB21 MMTA - Cardiac - Medium Earlv - Institutional 1 1.3199 

2HB31 MMTA - Cardiac - Medium Earlv - Institutional 2 1.4770 

2HC11 MMTA - Cardiac - High Earlv - Institutional 0 1.3628 

2HC21 MMTA - Cardiac - High Earlv - Institutional 1 1.4274 

2HC31 MMTA - Cardiac - High Earlv - Institutional 2 1.5845 
35904 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.026</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

2IA11 MMT A - Endocrine - Low Early - Institutional 0 1.3602 

2IA21 MMT A - Endocrine - Low Early - Institutional 1 1.4248 

2IA31 MMT A - Endocrine - Low Early - Institutional 2 1.5819 

2IB11 MMT A - Endocrine - Medium Earlv - Institutional 0 1.4781 

2IB21 MMT A - Endocrine - Medium Early - Institutional 1 1.5427 

2IB31 MMT A - Endocrine - Medium Early - Institutional 2 1.6998 

2IC11 MMT A - Endocrine - High Early - Institutional 0 1.5522 

21C21 MMT A - Endocrine - High Early - institutional 1 1.6168 

2IC31 MMT A - Endocrine - High Early - Institutional 2 1.7739 

2JAll MMT A - GI/GU - Low Early - Institutional 0 1.1134 

2JA21 MMT A - GI/GU - Low Early - Institutional 1 1.1780 

2JA31 MMTA - GI/GU - Low Early - Institutional 2 1.3351 

2JB11 MMT A - GI/GU - Medium Early - Institutional 0 1.2527 

2JB21 MMT A - GI/GU - Medium Early - Institutional 1 1.3173 

2JB31 MMT A - GI/GU - Medium Early - Institutional 2 1.4744 

2JC11 MMTA - GI/GU - High Early - Institutional 0 1.3435 

2JC21 MMTA - GI/GU - High Earlv - Institutional 1 1.4081 

2JC31 MMTA - GI/GU - High Early - Institutional 2 1.5652 

2KA11 MMT A - Infectious - Low Early - Institutional 0 1.1317 

2KA21 MMT A - Infectious - Low Early - Institutional 1 1.1962 

2KA31 MMT A - infectious - Low Early - institutional 2 1.3533 

2KBll MMTA - Infectious - Medium Early - Institutional 0 1.2532 

2KB21 MMT A - Infectious - Medium Early - Institutional l 1.3178 

2KB31 MMT A - Infectious - Medium Early - Institutional 2 1.4749 

2KC11 MMT A - Infectious - High Early - Institutional 0 1.3850 

2KC21 MMT A - Infectious - High Early - Institutional 1 1.4496 

2KC31 MMT A - Infectious - High Early - Institutional 2 1.6067 

2LA11 MMT A - Respiratory - Low Early - Institutional 0 1.1393 

2LA21 MMT A - Resoiratorv - Low Early - Institutional 1 1.2038 

2LA31 MMT A - Respiratorv - Low Earlv - Institutional 2 1.3609 

2LB11 MMT A - Respiratory - Medium Early - Institutional 0 1.2547 

2LB21 MMT A - Respiratorv - Medium Early - Institutional 1 1.3193 

2LB31 MMT A - Respiratory - Medium Early - Institutional 2 1.4764 

2LC11 MMT A - Respiratorv - High Early - institutional 0 1.3601 

2LC21 MMT A - Respiratory - High Early - Institutional l 1.4246 

2LC31 MMT A - Rcspiratorv - High Early - Institutional 2 1.5817 

3AA11 MMT A - Other - Low Late - Community 0 0.5540 

3AA21 MMT A - Other - Low Late - Communitv 1 0.6185 

3AA31 MMT A - Other - Low Late - Community 2 0.7756 

3AB11 MMT A - Other - Medium Late - Communitv 0 0.6712 

3AB21 MMT A - Other - Medium Late - Community 1 0.7358 

3AB31 MMT A - Other - Medium Late - Community 2 0.8929 

3AC11 MMT A - Other - High Lale - Communilv 0 0.7826 

3AC21 MMTA - Other - High Late - Community 1 0.8471 

3AC31 MMT A - Other - High Late - Commmtitv 2 1.0042 

3BA11 Neuro -Low Late - Comm1mity 0 0.7353 

3BA21 Neuro -Low Late - Community l 0.7999 

3BA31 Neuro - Low Late - Community 2 0.9570 

3BB11 Neuro - Medium Late - Community 0 0.8686 

3BB21 Neuro - Medium Late - Communitv 1 0.9332 

3BB31 Neuro - Medium Late - Communitv 2 1.0903 

3BC11 Neuro -High Late - Community 0 0.9905 

3BC21 Neuro -High Late - Community 1 1.0551 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35905 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.027</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

3BC31 Neuro -High Late - Community 2 1.2122 

3CA11 Wound-Low Late - Community 0 0.8500 

3CA21 Wound-Low Late - Community 1 0.9146 

3CA31 Wound-Low Late - Community 2 1.0717 

3CB11 Wound - Medium Late - Community 0 0.9693 

3CB21 Wound - Medium Late - Community 1 1.0338 

3CB31 Woimd - Medium Late - Comm1mity 2 1.1910 

3CC11 Wound -High Late - Community 0 1.0898 

3CC2l Wound - High Late - Community l l .l 543 

3CC31 Wound-High Late - Community 2 1.3114 

3DA11 Complex - Low Late - Community 0 0.4665 

3DA21 Complex - Low Late - Community 1 0.5311 

3DA31 Complex - Low Late - Community 2 0.6882 

3DB11 Complex - Medium Late - Community 0 0.6073 

3DB21 Complex - Medium Late - Community 1 0.6718 

3DB31 Complex - Medium Late - Community 2 0.8290 

3DC11 Complex - High Late - Connnunitv 0 0.5881 

3DC21 Complex - High Late - Connnunity 1 0.6527 

3DC31 Complex - High Late - Community 2 0.8098 

3EA11 MS Rehab - Low Late - Comm1mity 0 0.6257 

3EA21 MS Rehab - Low Late - Community 1 0.6903 

3EA3l MS Rehab - Low Late - Community 2 0.8474 

3EB11 MS Rehab - Medium Late - Community 0 0.7300 

3EB21 MS Rehab - Medium Late - Community 1 0.7945 

3EB31 MS Rehab - Medium Late - Community 2 0.9516 

3EC11 MS Rehab - High Late - Community 0 0.8913 

3EC21 MS Rehab - High Late - Community 1 0.9559 

3EC31 MS Rehab - High Late - Community 2 1.1130 

3FA11 Behavioral Health - Low Late - Community 0 0.4722 

3FA21 Behavioral Health - Low Late - Connnunitv 1 0.5367 

3FA31 Behavioral Health - Low Late - Connnunity 2 0.6938 

3FB11 Behavioral Health - Medium Late - Community 0 0.6303 

3FB21 Behavioral Health - Medium Late - Comm1mity 1 0.6948 

3FB31 Behavioral Health - Medium Late - Community 2 0.8519 

3FCll Behavioral Health - High Late - Community 0 0.7178 

3FC21 Behavioral Health - High Late - Community l 0.7824 

3FC31 Behavioral Health - High Late - Community 2 0.9395 

3GA11 MMT A - Surgical Aftercare - Low Late - Community 0 0.4951 

3GA21 MMT A - Surgical Aftercare - Low Late - Community 1 0.5597 

3GA31 MMT A - Surgical Aftercare - Low Late - Community 2 0.7168 

3GB11 MMT A - Surgical Aftercare - Medium Late - Community 0 0.6488 

3GB21 MMT A - Surgical Aftercare - Medium Late - Community 1 0.7134 

3GB31 MMTA - Surgical Aftercare - Medium Late - Connnunitv 2 0.8705 

3GC11 MMT A - Surgical Aftercare - High Late - Connnunity 0 0.8138 

3GC21 MMT A - Surgical Aftercare - High Late - Commmtity 1 0.8784 

3GC31 MMTA - Surgical Aftercare - High Late - Comrmmity 2 1.0355 

3HA11 MMTA - Cardiac - Low Late - Community 0 0.5218 

3HA21 MMT A - Cardiac - Low Late - Community I 0.5864 

3HA31 MMTA - Cardiac - Low Late - Community 2 0.7435 

3HB11 MMTA - Cardiac - Medium Late - Community 0 0.6464 

3HB21 MMTA - Cardiac - Medium Late - Community 1 0.7110 

3HB31 MMTA - Cardiac - Medium Late - Community 2 0.8681 

3HC11 MMTA - Cardiac - High Late - Community 0 0.7539 
35906 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.028</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

3HC21 MMTA - Cardiac - High Late - Community 1 0.8185 

3HC31 MMTA- Cardiac -High Late - Community 2 0.9756 

3IA11 MMT A - Endocrine - Low Late - Community 0 0.7513 

3IA21 MMT A - Endocrine - Low Late - Connnunity 1 0.8159 

3IA31 MMT A - Endocrine - Low Late - Connnunity 2 0.9730 

3IB11 MMTA - Endocrine - Medium Late - Community 0 0.8692 

3IB21 MMTA - Endocrine - Medium Late - Comm1mity 1 0.9338 

31831 MMTA - Endocrine - Medium Late - Community 2 1.0909 

3TCl l MMT A - Endocrine - High Late - Community 0 0.9433 

3IC21 MMT A - Endocrine - High Late - Community l 1.0078 

3IC31 MMT A - Endocrine - High Late - Community 2 1.1650 

3JA11 MMTA- GI/GU -Low Late - Community 0 0.5045 

3JA21 MMTA- GI/GU -Low Late - Community 1 0.5691 

3JA31 MMTA- GI/GU -Low Late - Community 2 0.7262 

3JB11 MMT A - GI/GU - Medium Late - Community 0 0.6438 

3JB21 MMT A - GI/GU - Medium Late - Community 1 0.7084 

3JB31 MMT A - GI/GU - Medium Late - Connnunitv 2 0.8655 

3JC11 MMTA - GI/GU - High Late - Connnunity 0 0.7346 

3JC21 MMTA - GI/GU - High Late - Community 1 0.7991 

3JC31 MMTA - GI/GU - High Late - Comm1mity 2 0.9563 

3KA11 MMT A - Infectious - Low Late - Community 0 0.5227 

3KA21 MMTA - Infectious - Low Late - Community l 0.5873 

3KA31 MMT A - Infectious - Low Late - Community 2 0.7444 

3KB11 MMT A - Infectious - Medium Late - Community 0 0.6443 

3KB21 MMT A - Infectious - Medium Late - Community 1 0.7089 

3KB31 MMT A - Infectious - Medium Late - Community 2 0.8660 

3KC11 MMT A - Infectious - High Late - Community 0 0.7761 

3KC21 MMT A - Infectious - High Late - Community 1 0.8407 

3KC31 MMT A - Infectious - Hhrh Late - Community 2 0.9978 

3LA11 MMT A - Respiratorv - Low Late - Connnunitv 0 0.5303 

3LA21 MMT A - Respiratory - Low Late - Connnunity 1 0.5949 

3LA31 MMT A - Respiratorv - Low Late - Community 2 0.7520 

3LB11 MMT A - Respiratory - Medium Late - Comm1mity 0 0.6458 

3LB21 MMT A - Respiratorv - Medium Late - Community 1 0.7104 

3LB3l MMT A - Respiratory - Medium Late - Community 2 0.8675 

3LC11 MMT A - Rcspiratorv - High Late - Community 0 0.7511 

3LC21 MMT A - Respiratory - High Late - Community 1 0.8157 

3LC31 MMT A - Respiratorv - High Late - Community 2 0.9728 

4AA11 MMTA - Other - Low Late - Institutional 0 1.0690 

4AA21 MMTA - Other - Low Late - Institutional 1 1.1336 

4AA31 MMTA - Other - Low Late - Institutional 2 1.2907 

4AB11 MMT A - Other - Medium Late - Institutional 0 1.1863 

4AB21 MMT A - Other - Medium Late - Institutional 1 1.2509 

4AB31 MMT A - Other - Medium Late - Institutional 2 1.4080 

4AC11 MMT A - Other - High Late - Institutional 0 1.2976 

4AC21 MMTA - Other - High Late - Institutional 1 1.3622 

4AC3I MMT A - Other - High Late - Institutional 2 l.5I93 

4BAII Neuro - Low Late - T nstitutiona I 0 1.2504 

4BA21 Ncuro-Low Late - Institutional 1 1.3150 

4BA31 Neuro-Low Late - Institutional 2 1.4721 

4BB11 Neuro - Medium Late - Institutional 0 1.3837 

4BB21 Neuro - Medium Late - Institutional 1 1.4483 

4BB31 Neuro - Medium Late - Institutional 2 1.6054 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35907 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.029</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

4BC11 Neuro-High Late - Institutional 0 1.5056 

4BC21 Neuro-High Late - Institutional 1 1.5702 

4BC31 Neuro-High Late - Institutional 2 1.7273 

4CA11 Wound-Low Late - Institutional 0 1.3651 

4CA21 Wound-Low Late - Institutional 1 1.4297 

4CA31 Wound-Low Late - Institutional 2 1.5868 

4CB11 Wound - Medium Late - Institutional 0 1.4844 

4CB21 Wound - Medium Late - Institutional 1 1.5489 

4CB3l Wound- Medium Late - T nstitutiona I 2 1.7060 

4CC11 Wound-High Late - Institutional 0 1.6048 

4CC21 Wound-High Late - Institutional 1 1.6694 

4CC31 Wound-High Late - Institutional 2 1.8265 

4DA11 Complex - Low Late - Institutional 0 0.9816 

4DA21 Complex - Low Late - Institutional 1 1.0462 

4DA31 Complex - Low Late - Institutional 2 1.2033 

4DB11 Complex - Medium Late - Institutional 0 1.1224 

4DB21 Complex - Medium Late - Institutional 1 1.1869 

4DB31 Complex - Medium Late - Institutional 2 1.3440 

4DC11 Complex - High Late - Institutional 0 1.1032 

4DC21 Complex - High Late - Institutional 1 1.1678 

4DC31 Complex - High Late - Institutional 2 1.3249 

4EAll MS Rehab - Low Late - T nstitutiona I o l.1408 

4EA2I MS Rehab - Low Late - Institutional I 1.2053 

4EA31 MS Rehab - Low Late - Institutional 2 1.3625 

4EB11 MS Rehab - Medium Late - Institutional 0 1.2450 

4EB21 MS Rehab - Medium Late - Institutional 1 1.3096 

4EB31 MS Rehab - Medium Late - Institutional 2 1.4667 

4EC11 MS Rehab - High Late - Institutional 0 1.4064 

4EC21 MS Rehab - High Late - Institutional 1 1.4710 

4EC31 MS Rehab - High Late - Institutional 2 1.6281 

4FA11 Behavioral Health - Low Late - Institutional 0 0.9872 

4FA21 Behavioral Health - Low Late - Institutional 1 1.0518 

4FA31 Behavioral Health - Low Late - Institutional 2 1.2089 

4FB11 Behavioral Health - Medium Late - Institutional 0 1.1453 

4FB2l Behavioral Health - Medium Late - T nstitutiona I l 1.2099 

4FB3I Behavioral Health - Medium Late - Institutional 2 1.3670 

4FC11 Behavioral Health - High Late - Institutional 0 1.2329 

4FC21 Behavioral Health - High Late - Institutional 1 1.2974 

4FC31 Behavioral Health - High Late - Institutional 2 1.4546 

4GA11 MMT A - Surgical Aftercare - Low Late - Institutional 0 1.0102 

4GA21 MMT A - Surgical Aftercare - Low Late - Institutional 1 1.0748 

4GA31 MMT A - Surgical Aftercare - Low Late - Institutional 2 1.2319 

4GB11 MMTA - Surgical Aftercare - Medium Late - Institutional 0 1.1639 

4GB21 MMT A - Surgical Aftercare - Medimn Late - Institutional 1 1.2285 

4GB31 MMT A - Surgical Aftercare - Medimn Late - Institutional 2 1.3856 

4GC11 MMTA - Surgical Aftercare - High Late - Institutional 0 1.3289 

4GC2I MMT A - Surgical Aftercare - High Late - Institutional I 1.3934 

4GC31 MMTA - Surgical Aftercare - High Late - T nstitutiona I 2 1.5506 

4HA11 MMTA - Cardiac - Low Late - Institutional 0 1.0369 

4HA21 MMTA - Cardiac - Low Late - Institutional 1 1.1014 

4HA31 MMTA - Cardiac - Low Late - Institutional 2 1.2586 

4HB11 MMTA - Cardiac - Medium Late - Institutional 0 1.1615 

4HB21 MMTA - Cardiac - Medium Late - Institutional 1 1.2260 
35908 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

BILLING CODE 4120–01–C 

To ensure the changes to the PDGM 

case-mix weights are implemented in a 

budget neutral manner, we then apply a 

case-mix budget neutrality factor to the 

CY 2022 national, standardized 30-day 

period payment rate. Typically, the 

case-mix weight budget neutrality factor 

is calculated using the most recent, 

complete home health claims data 

available. However, due to the COVID– 

19 PHE, we looked at using the previous 

calendar year’s home health claims data 

(CY 2019) to determine if there were 

significant differences between utilizing 

CY 2019 and CY 2020 claims data. We 

note that CY 2020 is the first year of 

actual PDGM utilization data, therefore, 

if we were to use CY 2019 data due to 

the PHE we would need to simulate 30- 

day periods from 60-day episodes under 

the old system. We believe that using 

CY 2020 utilization data is more 

appropriate than using CY 2019 

utilization data because it is actual 

PDGM utilization data. The case-mix 

budget neutrality factor is calculated as 

the ratio of 30-day base payment rates 

such that total payments when the CY 

2022 PDGM case-mix weights 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.030</GPH>

Comorbidity 

Admission Source and Adjustment 

HIPPS Clinical Group and Functional Level Timing (0 = none, 1 = single Weight 

comorbidity, 

2 = interaction) 

4HB31 MMT A - Cardiac - Medium Late - Institutional 2 1.3832 

4HC11 MMT A - Cardiac - High Late - Institutional 0 1.2690 

4HC21 MMT A - Cardiac - High Late - Institutional 1 1.3335 

4HC31 MMT A - Cardiac - High Late - Institutional 2 1.4907 

41All MMT A - Endocrine - Low Late - Institutional 0 1.2664 

4IA21 MMT A - Endocrine - Low Late - Institutional 1 1.3309 

4IA31 MMT A - Endocrine - Low Late - Institutional 2 1.4881 

41Bll MMT A - Endocrine - Medium Late - Institutional 0 1.3843 

4IB21 MMT A - Endocrine - Medium Late - Institutional 1 1.4489 

4IB31 MMT A - Endocrine - Medium Late - Institutional 2 1.6060 

4IC11 MMT A - Endocrine - High Late - Institutional 0 1.4584 

4IC21 MMT A - Endocrine - High Late - Institutional 1 1.5229 

4IC31 MMT A - Endocrine - High Late - Institutional 2 1.6800 

4JA11 MMT A - GI/GU - Low Late - Institutional 0 1.0196 

4JA21 MMT A - GI/GU - Low Late - Institutional 1 1.0841 

4JA31 MMT A - GI/GU - Low Late - Institutional 2 1.2413 

4JB11 MMT A - GI/GU - Medium Late - Institutional 0 1.1589 

4JB21 MMT A - GI/GU - Medium Late - Institutional 1 1.2234 

4JB31 MMT A - GI/GU - Medium Late - Institutional 2 1.3806 

4JC11 MMT A - GI/GU - High Late - Institutional 0 1.2497 

4JC21 MMT A - GI/GU - High Late - Institutional 1 1.3142 

4JC31 MMT A - GI/GU - High Late - Institutional 2 1.4713 

4KA11 MMT A - Infectious - Low Late - Institutional 0 1.0378 

4KA21 MMT A - Infectious - Low Late - Institutional 1 1.1024 

4KA31 MMT A - Infectious - Low Late - Institutional 2 1.2595 

4KB11 MMT A - Infectious - Medium Late - Institutional 0 1.1594 

4KB21 MMT A - Infectious - Medium Late - Institutional 1 1.2240 

4KB31 MMT A - Infectious - Medium Late - Institutional 2 1.3811 

4KC11 MMT A - Infectious - High Late - Institutional 0 1.2912 

4KC21 MMT A - Infectious - High Late - Institutional 1 1.3558 

4KC31 MMT A - Infectious - High Late - Institutional 2 1.5129 

4LA11 MMT A - Respiratory - Low Late - Institutional 0 1.0454 

4LA21 MMT A - Respiratory - Low Late - Institutional 1 1.1100 

4LA31 MMT A - Respiratory - Low Late - Institutional 2 1.2671 

4LB11 MMT A - Respiratory - Medium Late - Institutional 0 1.1609 

4LB21 MMT A - Respiratory - Medium Late - Institutional 1 1.2255 

4LB31 MMT A - Respiratory - Medium Late - Institutional 2 1.3826 

4LC11 MMT A - Respiratory - High Late - Institutional 0 1.2662 

4LC21 MMT A - Respiratory - High Late - Institutional 1 1.3308 

4LC31 MMT A - Respiratory - High Late - Institutional 2 1.4879 

Source: CY 2020 Home Health Claims Data, Periods that begin and end in CY 2020 accessed from the CCW March 

30, 2021. 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35909 

(developed using CY 2020 home health 

claims data) are applied to CY 2020 

utilization (claims) data are equal to 

total payments when CY 2021 PDGM 

case-mix weights (developed using CY 

2018 home health claims data) are 

applied to CY 2020 utilization data. 

This produces a case-mix budget 

neutrality factor for CY 2022 of 1.0344. 

For reasons described previously, CY 

2020 utilization data was used to 

calculate the case-mix weight budget 

neutrality factor because it is the most 

recent complete data we have at the 

time of this rulemaking. 

We invite comments on the CY 2022 

proposed case-mix weights and 

proposed case-mix weight budget 

neutrality factor. 

4. Proposed CY 2022 Home Health 

Payment Rate Updates 

a. Proposed CY 2022 Home Health 

Market Basket Update for HHAs 

Section 1895(b)(3)(B) of the Act 

requires that the standard prospective 

payment amounts for home health 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 cost report data. As such, based on 

the rebased 2016-based home health 

market basket, we finalized that the 

labor share is 76.1 percent and the nonlabor 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 

changes 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 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 2022 is based on the 

estimated home health market basket 

update, specified at section 

1895(b)(3)(B)(iii) of the Act, of 2.4 

percent (based on IHS Global Inc.’s firstquarter 2021 forecast with historical 

data through fourth-quarter 2020). The 

estimated CY 2022 home health market 

basket update of 2.4 percent is then 

reduced by a productivity 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 0.6 

percentage point for CY 2022. In effect, 

the proposed home health payment 

update percentage for CY 2022 is a 1.8 

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 

2022, the home health payment update 

would be ¥0.2 percent (1.8 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 productivity adjustment), we would 

use such data, if appropriate, to 

determine the home health payment 

update percentage for CY 2022 in the 

final rule. 

b. CY 2022 Home Health Wage Index 

Sections 1895(b)(4)(A)(ii) and (b)(4)(C) 

of the Act require the Secretary to 

provide appropriate adjustments to the 

proportion of the payment amount 

under the HH PPS that account for area 

wage differences, using adjustment 

factors that reflect the relative level of 

wages and wage-related costs applicable 

to the furnishing of home health 

services. Since the inception of the HH 

PPS, we have used inpatient hospital 

wage data in developing a wage index 

to be applied to home payments. We 

propose to continue this practice for CY 

2022, as we continue to believe that, in 

the absence of home health-specific 

wage data that accounts for area 

differences, using inpatient hospital 

wage data is appropriate and reasonable 

for the HH PPS. 

In the FY 2021 HH PPS final rule (85 

FR 70298), we finalized the proposal to 

adopt the revised OMB delineations 

with a 5 percent cap on wage index 

decreases, where the estimated 

reduction in a geographic area’s wage 

index would be capped at 5 percent in 

CY 2021 only and no cap would be 

applied to wage index decreases for the 

second year (CY 2022). Therefore, we 

propose to use the FY 2022 pre-floor, 

pre-reclassified hospital wage index 

with no 5 percent cap on decreases as 

the CY 2022 wage adjustment to the 

labor portion of the HH PPS rates. For 

CY 2022, the updated wage data are for 

hospital cost reporting periods 

beginning on or after October 1, 2017, 

and before October 1, 2018 (FY 2018 

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 

2022 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 

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 2022, the only 

urban area without inpatient hospital 

wage data is Hinesville, GA (CBSA 

25980). The CY 2022 wage index value 

for Hinesville, GA is 0.8557. 

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 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35910 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

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 2022 HH PPS 

wage index value for CBSA 46300, Twin 

Falls, Idaho, will be 0.8757. Bulletin No. 

17–01 is available at 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.bls.gov/bls/ 

omb-bulletin-18-04-reviseddelineations-of-metropolitan-statisticalareas.pdf. 

On March 6, 2020, OMB issued 

Bulletin No. 20–01, which provided 

updates to and superseded OMB 

Bulletin No. 18–04 that was issued on 

September 14, 2018. The attachments to 

OMB Bulletin No. 20–01 provided 

detailed information on the update to 

statistical areas since September 14, 

2018, and were based on the application 

of the 2010 Standards for Delineating 

Metropolitan and Micropolitan 

Statistical Areas to Census Bureau 

population estimates for July 1, 2017 

and July 1, 2018. (For a copy of this 

bulletin, we refer readers to https://

www.whitehouse.gov/wp-content/ 

uploads/2020/03/Bulletin-20-01.pdf). In 

OMB Bulletin No. 20–01, OMB 

announced one new Micropolitan 

Statistical Area, one new component of 

an existing Combined Statistical Are 

and changes to New England City and 

Town Area (NECTA) delineations. In 

the CY 2021 HH PPS final rule (85 FR 

70298) we stated that if appropriate, we 

would propose any updates from OMB 

Bulletin No. 20–01 in future 

rulemaking. After reviewing OMB 

Bulletin No. 20–01, we have determined 

that the changes in Bulletin 20–01 

encompassed delineation changes that 

would not affect the Medicare wage 

index for CY 2022. Specifically, the 

updates consisted of changes to NECTA 

delineations and the redesignation of a 

single rural county into a newly created 

Micropolitan Statistical Area. The 

Medicare wage index does not utilize 

NECTA definitions, and, as most 

recently discussed in the CY 2021 HH 

PPS final rule (85 FR 70298) we include 

hospitals located in Micropolitan 

Statistical areas in each State’s rural 

wage index. Therefore, while we are 

proposing to adopt the updates set forth 

in OMB Bulletin No. 20–01 consistent 

with our longstanding policy of 

adopting OMB delineation updates, we 

note that specific wage index updates 

would not be necessary for CY 2022 as 

a result of adopting these OMB updates. 

In other words, these OMB updates 

would not affect any geographic areas 

for purposes of the wage index 

calculation for CY 2022. 

The proposed CY 2022 wage index is 

available on the CMS website at: https:// 

www.cms.gov/Center/Provider-Type/ 

Home-Health-Agency-HHA-Center. 

c. CY 2022 Annual Payment Update 

(1) Background 

The 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 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 § 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 data. We also finalized a 

revision to the labor 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 share would be 76.1 percent and 

the non-labor share would be 23.9 

percent. The following are the steps we 

take to compute the case-mix and wageadjusted 30-day period payment amount 

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 casemix and wage adjusted 30-day period 

payment amount, 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 § 484.225(i), for an HHA that does 

not submit home health quality data, as 

specified by the Secretary, the 

unadjusted national prospective 30-day 

period rate is equal to the rate for the 

previous calendar year increased by the 

applicable home health payment 

update, minus 2 percentage points. Any 

reduction of the percentage change 

would apply only to the calendar year 

involved and would not be considered 

in computing the prospective payment 

amount for a subsequent calendar year. 

The final claim that the HHA submits 

for payment determines the total 

payment amount for the period and 

whether we make an applicable 

adjustment to the 30-day case-mix and 

wage-adjusted payment amount. The 

end date of the 30-day period, as 

reported on the claim, determines 

which calendar year rates Medicare will 

use to pay the claim. 

We may adjust a 30-day case-mix and 

wage-adjusted payment based on the 

information submitted on the claim to 

reflect the following: 

• A LUPA is provided on a per-visit 

basis as set forth in §§ 484.205(d)(1) and 

484.230. 

• A PEP adjustment as set forth in 

§§ 484.205(d)(2) and 484.235. 

• An outlier payment as set forth in 

§§ 484.205(d)(3) and 484.240. 

(2) CY 2022 National, Standardized 30- 

Day Period Payment Amount 

CMS provided preliminary 

monitoring data for the first year of 

PDGM and presented a repricing 

method to determine the differences 

between assumed and actual behavior 

changes and the impact of such on 

estimated aggregate expenditures, as 

discussed in Section III.B of this 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35911 

proposed rule. For CY 2022, we are not 

proposing to make any additional 

permanent or temporary adjustments to 

the national, standardized 30-day period 

payment in this proposed rule in 

accordance with section 1895(b)(3)(D) of 

the Act. 

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 2022 

national, standardized 30-day period 

payment rate, we apply a case-mix 

weights recalibration budget neutrality 

factor, a wage index budget neutrality 

factor and the home health payment 

update percentage discussed in Section 

III.C.2 of this proposed rule. As 

discussed previously, to ensure the 

changes to the PDGM case-mix weights 

are implemented in a budget neutral 

manner, we apply a case-mix weights 

budget neutrality factor to the CY 2021 

national, standardized 30-day period 

payment rate. The proposed case-mix 

weights budget neutrality factor for CY 

2022 is 1.0344. 

Additionally, we also apply a wage 

index budget neutrality to ensure that 

wage index updates and revisions are 

implemented in a budget neutral 

manner. Typically, the wage index 

budget neutrality factor is calculated 

using the most recent, complete home 

health claims data available. However, 

due to the COVID–19 PHE, we looked at 

using the previous calendar year’s home 

health claims data (CY 2019) to 

determine if there were significant 

differences between utilizing 2019 and 

2020 claims data. Our analysis showed 

that there is only a small difference 

between the wage index budget 

neutrality factors calculated using CY 

2019 and CY 2020 home health claims 

data. Therefore, we have decided to 

continue our practice of using the most 

recent, complete home health claims 

data available; that is we are using CY 

2020 claims data for the CY 2022 

payment rate updates. 

To calculate the wage index budget 

neutrality factor, we simulated total 

payments using CY 2020 home health 

claims utilization data for non-LUPA 

30-day periods using the proposed CY 

2022 wage index and compared it to our 

simulation of total payments for nonLUPA 30-day periods using the CY 2021 

wage index. By dividing the total 

payments for non-LUPA 30-day periods 

using the CY 2022 wage index by the 

total payments for non-LUPA 30-day 

periods using the CY 2021 wage index, 

we obtain a wage index budget 

neutrality factor of 1.0013. We would 

apply the wage index budget neutrality 

factor of 1.0013 to the 30-day period 

payment rate. 

Next, we would update the 30-day 

period payment rate by the CY 2022 

home health payment update percentage 

of 1.8 percent. The CY 2022 national, 

standardized 30-day period payment 

rate is calculated in Table 19. 

The CY 2022 national, standardized 

30-day period payment rate for a HHA 

that does not submit the required 

quality data is updated by the CY 2022 

home health payment update of 1.8 

percent minus 2 percentage points and 

is shown in Table 20. 

(3) CY 2022 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 2022 national pervisit rates, we started with the CY 2021 

national per-visit rates. Then we applied 

a wage index budget neutrality factor to 

ensure budget neutrality for LUPA perVerDate Sep<11>2014 18:28 Jul 06, 2021 Jkt 253001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 E:\FR\FM\07JYP2.SGM 07JYP2

khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.031</GPH> EP07JY21.032</GPH>

TABLE 19: CY 2022 NATIONAL, STANDARDIZED 30-DAY PERIOD PAYMENT 

AMOUNT 

Case-Mix 

CY 2021 National Weights Wage Index CY 2022 National, 

Standardized 30- Recalibration Budget CY2022HH Standardized 30-

Day Period Neutrality Neutrality Payment Day Period 

Payment Factor Factor Update Payment 

$1,901.12 1.0390 1.0013 1.018 $2,013.43 

TABLE 20: CY 2022 NATIONAL, STANDARDIZED 30-DAY PERIOD PAYMENT 

AMOUNT FOR HHAS THAT DO NOT SUBMIT THE QUALITY DATA 

CY 2021 National Case-Mix Wage Index CY2022HH CY 2022 National, 

Standardized 30- Weights Budget Payment Standardized 30-

Day Period Recalibration Neutrality Update Minus Day Period 

Payment Neutrality Factor 2 Percentage Payment 

Factor Points 

$1,901.12 1.0390 1.0013 0.998 $1,973.88 
35912 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

visit payments. We calculated the wage 

index budget neutrality factor by 

simulating total payments for LUPA 30- 

day periods of care using the CY 2022 

wage index and comparing it to 

simulated total payments for LUPA 30- 

day periods of care using the CY 2021 

wage index. By dividing the total 

payments for LUPA 30-day periods of 

care using the CY 2022 wage index by 

the total payments for LUPA 30-day 

periods of care using the CY 2021 wage 

index, we obtained a wage index budget 

neutrality factor of 1.0014. We apply the 

wage index budget neutrality factor in 

order to calculate the CY 2022 national 

per-visit rates. 

The LUPA per-visit rates are not 

calculated using case-mix weights. 

Therefore, no case-mix weights budget 

neutrality factor is needed to ensure 

budget neutrality for LUPA payments. 

Lastly, the per-visit rates for each 

discipline are updated by the CY 2022 

home health payment update percentage 

of 1.8 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 addon payment amount, which is paid for 

episodes that occur as the only episode 

or initial episode in a sequence of 

adjacent episodes. The CY 2022 national 

per-visit rates for HHAs that submit the 

required quality data are updated by the 

CY 2022 home health payment update 

percentage of 1.8 percent and are shown 

in Table 21. 

The CY 2022 per-visit payment rates 

for HHAs that do not submit the 

required quality data are updated by the 

CY 2020 home health payment update 

percentage of 1.8 percent minus 2 

percentage points and are shown in 

Table 22. 

We are reminding stakeholders of the 

policies finalized in the CY 2020 HH 

PPS final rule with comment period (84 

FR 60544) 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 Requests for Anticipated 

Payment (RAPs) 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) were required to 

submit a RAP at the beginning of each 

30-day period in order to establish the 

home health period of care in the 

common working file and also to trigger 

the consolidated billing edits. With the 

removal of the upfront RAP payment for 

CY 2021, we relaxed the required 

information for submitting the RAP for 

CY 2021 and 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 the one-time NOA for CYs 2022 and 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.033</GPH> EP07JY21.034</GPH>

TABLE 21: CY 2022 NATIONAL PER-VISIT PAYMENT AMOUNTS 

Wage Index 

CY 2021 Budget CY 2022 CY2022 

Per-Visit Neutrality HHPayment Per-Visit 

HH Discipline Payment Factor Update Payment 

Home Health Aide $69.11 X 1.0014 X 1.018 $70.45 

Medical Social Services $244.64 X 1.0014 X 1.018 $249.39 

Occupational Theraov $167.98 X 1.0014 X 1.018 $171.24 

Physical Theraov $166.83 X 1.0014 X 1.018 $170.07 

Skilled Nursing $152.63 X 1.0014 X 1.018 $155.59 

Speech-Languruze Patholo!!v $181.34 X 1.0014 X 1.018 $184.86 

TABLE 22: CY 2022 NATIONAL PER-VISIT PAYMENT AMOUNTS 

FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA 

Wage CY 2022 

CY 2021 Index HHPayment CY2022 

HH Discipline Per-Visit Budget Update Minus Per-Visit 

Rates Neutrality 2 Percentage Rates 

Factor Points 

Home Health Aide $69.11 X 1.0014 X 0.998 $69.07 

Medical Social Services $244.64 X 1.0014 X 0.998 $244.49 

Occupational Therapy $167.98 X 1.0014 X 0.998 $167.88 

Physical Therapy $166.83 X 1.0014 X 0.998 $166.73 

Skilled Nursing $152.63 X 1.0014 X 0.998 $152.54 

Speech- Language Patholo!!v $181.34 X 1.0014 X 0.998 $181.23 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35913 

beyond, we finalized a payment 

reduction if the HHA does not submit 

the 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 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 date the HHA submitted the 

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 NOA, no LUPA payments 

would be made for days that fall within 

the period of care prior to the 

submission of the 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. 

We remind stakeholders that for 

purposes of determining if an NOA is 

timely-filed, the NOA must be 

submitted within 5 calendar days after 

the start of care for the first 30-day 

period of care. For example, if the start 

of care for the first 30-day period is 

January 1, 2022, the NOA would be 

considered timely-filed if it is submitted 

on or before January 6, 2022. 

Example 

1/1/2022 = Day 0 (start of the first 30- 

day period of care) 

1/6/2022 = Day 5 (An NOA submitted 

on or before this date would be 

considered ‘‘timely-filed’’.) 

1/7/2022 and after = Day 6 and 

beyond (An NOA submitted on and after 

this date will trigger the penalty.) In the 

event that the NOA is not timely-filed, 

the penalty is calculated from the first 

day of that 30-day period (in the 

example, the penalty calculation would 

begin with the start of care date of 

January 1, 2022, counting as the first 

day of the penalty) until the date of the 

submission of the NOA. 

Also, in the CY 2020 HH PPS final 

rule with comment period (84 FR 

60478), we finalized exceptions to the 

timely filing consequences of the NOA 

requirements at § 484.205(j)(4). 

Specifically, we finalized that CMS may 

waive the consequences of failure to 

submit a timely-filed NOA if it is 

determined that a circumstance 

encountered by a home health agency is 

exceptional and qualifies for waiver of 

the consequence. As finalized in the CY 

2020 HH PPS final rule with comment 

period and as set forth in regulation at 

§ 484.205(j)(4), an exceptional 

circumstance may be due to, but is not 

limited to the following: 

• Fires, floods, earthquakes, or 

similar unusual events that inflict 

extensive damage to the home health 

agency’s ability to operate. 

• A CMS or Medicare contractor 

systems issue that is beyond the control 

of the home health agency. 

• A newly Medicare-certified home 

health agency that is notified of that 

certification after the Medicare 

certification date, or which is awaiting 

its user ID from its Medicare contractor. 

• Other situations determined by 

CMS to be beyond the control of the 

home health agency. 

If an HHA believes that there is a 

circumstance that may qualify for an 

exception, the HHA must fully 

document and furnish any requested 

documentation to their MAC for a 

determination of exception. 

For more in-depth information 

regarding the finalized policies 

associated with the new one-time NOA 

process, we refer readers to the CY 2020 

HH PPS final rule with comment period 

(84 FR 60544) as well as the regulations 

at § 484.205(j). 

(4) 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, 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 speechlanguage 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 2022 

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 $287.06 (1.8451 multiplied by 

$155.58), subject to area wage 

adjustment. 

(5) Proposed Occupational Therapy 

LUPA Add-On Factor 

In order to implement Division CC, 

section 115, of CAA 2021, we are 

proposing conforming changes to 

regulations at §§ 484.55(a)(2) and 

484.55(b)(3) that were revised to allow 

OTs to conduct initial and 

comprehensive assessments for all 

Medicare beneficiaries under the home 

health benefit when the plan of care 

does not initially include skilled 

nursing care, but includes either PT or 

SLP. Because of this change, we are 

proposing to establish a LUPA add-on 

factor for calculating the LUPA add-on 

payment amount for the first skilled 

occupational therapy visit in LUPA 

periods that occurs as the only period of 

care or the initial 30-day period of care 

in a sequence of adjacent 30-day periods 

of care. Currently, there are no sufficient 

data regarding the average excess of 

minutes for the first visit in LUPA 

periods where the initial and 

comprehensive assessments are 

conducted by occupational therapists. 

Therefore, we propose to utilize the PT 

LUPA add-on factor of 1.6700 as a proxy 

until we have CY 2022 data to establish 

a more accurate OT add-on factor for the 

LUPA add-on payment amounts. We 

believe that the similarity in the pervisit payment rates for both PT and OT 

make the PT LUPA add-on factor the 

most appropriate proxy. We welcome 

comments on this proposal. 

d. Rural Add-On Payments for CY 2022 

(1) Background 

Section 421(a) of the Medicare 

Prescription Drug Improvement and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173) required, for home health 

services furnished in a rural area (as 

defined in section 1886(d)(2)(D) of the 

Act), for episodes or visits ending on or 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35914 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

after April 1, 2004, and before April 1, 

2005, that the Secretary increase the 

payment amount that otherwise would 

have been made under section 1895 of 

the Act for the services by 5 percent. 

Section 5201 of the Deficit Reduction 

Act of 2003 (DRA) (Pub. L. 108–171) 

amended section 421(a) of the MMA. 

The amended section 421(a) of the 

MMA required, for home health services 

furnished in a rural area (as defined in 

section 1886(d)(2)(D) of the Act), on or 

after January 1, 2006, and before January 

1, 2007, that the Secretary increase the 

payment amount otherwise made under 

section 1895 of the Act for those 

services by 5 percent. 

Section 3131(c) of the Affordable Care 

Act amended section 421(a) of the MMA 

to provide an increase of 3 percent of 

the payment amount otherwise made 

under section 1895 of the Act for home 

health services furnished in a rural area 

(as defined in section 1886(d)(2)(D) of 

the Act), for episodes and visits ending 

on or after April 1, 2010, and before 

January 1, 2016. Section 210 of the 

MACRA amended section 421(a) of the 

MMA to extend the rural add-on by 

providing an increase of 3 percent of the 

payment amount otherwise made under 

section 1895 of the Act for home health 

services provided in a rural area (as 

defined in section 1886(d)(2)(D) of the 

Act), for episodes and visits ending 

before January 1, 2018. 

Section 50208(a) of the BBA of 2018 

amended section 421(a) of the MMA to 

extend the rural add-on by providing an 

increase of 3 percent of the payment 

amount otherwise made under section 

1895 of the Act for home health services 

provided in a rural area (as defined in 

section 1886(d)(2)(D) of the Act), for 

episodes and visits ending before 

January 1, 2019. 

(2) Rural Add-On Payments for CYs 

2019 Through CY 2022 

Section 50208(a)(1)(D) of the BBA of 

2018 added a new subsection (b) to 

section 421 of the MMA to provide rural 

add-on payments for episodes or visits 

ending during CYs 2019 through 2022. 

It also mandated implementation of a 

new methodology for applying those 

payments. Unlike previous rural addons, 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-ServicePayment/HomeHealthPPS/HomeHealth-Prospective-Payment-SystemRegulations-and-Notices.html. In 

addition, an Excel file containing the 

rural county or equivalent area name, 

their Federal Information Processing 

Standards (FIPS) State and county 

codes, and their designation into one of 

the three rural add-on categories is 

available for download. 

The HH PRICER module, located 

within CMS’ claims processing system, 

will increase the CY 2022 30-day base 

payment rates, described in section 

III.C.3. 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 23. 

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 and 

the previous unit of payment (that is, 

60-day episodes), outlier payments were 

made for 60-day 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 PEP adjustment 

defined as the 60-day episode payment 

or PEP adjustment for that group plus a 

fixed-dollar loss (FDL) amount. For the 

purposes of the HH PPS, the FDL 

amount is calculated by multiplying the 

home health FDL ratio by a case’s wageadjusted 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 wageadjusted threshold. The proportion of 

additional costs over the outlier 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.035</GPH>

TABLE 23: HOME HEALTH PPS RURAL ADD-ON PERCENTAGES, 

CYs 2019-2022 

Category CY 2019 CY 2020 CY 2021 CY2022 

High utilization 1.5% 0.5% None None 

Low population density 4.0% 3.0% 2.0% 1.0% 

All other 3.0% 2.0% 1.0% None 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35915 

threshold amount paid as outlier 

payments is referred to as the losssharing 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 revised 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 addon 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 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 costper-unit approach rather than a cost-pervisit 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 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-perunit 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. 

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, the per unit rates used to 

estimate an episode’s cost were 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 

will continue to monitor the visit length 

by discipline as more recent data 

becomes available, and may propose to 

update the rates as needed in the future. 

In the CY 2019 HH PPS final rule with 

comment period (83 FR 56521), we 

finalized a policy to maintain the 

current methodology for payment of 

high-cost outliers upon implementation 

of PDGM beginning in CY 2020 and 

calculated payment for high-cost 

outliers based upon 30-day period of 

care. Upon implementation of the 

PDGM and 30-day unit of payment, we 

finalized the FDL ratio of 0.56 for 30- 

day periods of care in CY 2020. Given 

that CY 2020 was the first year of the 

PDGM and the change to a 30-day unit 

of payment, we finalized to maintain the 

same FDL ratio of 0.56 in CY 2021 as we 

did not have sufficient CY 2020 data at 

the time of CY 2021 rulemaking to 

proposed a change to the FDL ratio for 

CY 2021. 

(2) Fixed Dollar Loss (FDL) Ratio for CY 

2022 

For a given level of outlier payments, 

there is a trade-off between the values 

selected for the FDL ratio and the losssharing 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 be lower. 

The FDL ratio and the loss-sharing 

ratio are 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 losssharing ratio of 0.80, Medicare pays 80 

percent of the additional estimated costs 

that exceed the outlier threshold 

amount. Using CY 2020 claims data (as 

of March 30, 2021), and given the 

statutory requirement that total outlier 

payments does not exceed 2.5 percent of 

the total payments estimated to be made 

under the HH PPS, we are proposing a 

FDL ratio of 0.41 for CY 2022. 

6. Conforming Regulations Text Changes 

Regarding Allowed Practitioners 

As stated in the May 2020 COVID–19 

interim final rule with comment period 

(85 FR 27550), we amended the 

regulations at parts 409, 424, and 484 to 

implement section 3708 of the CARES 

Act. This included defining a nurse 

practitioner (NP), a clinical nurse 

specialist (CNS), and a physician’s 

assistant (PA) (as such qualifications are 

defined at §§ 410.74 through 410.76) as 

‘‘allowed practitioners’’ (85 FR 27572). 

This means that in addition to a 

physician, as defined at section 1861(r) 

of the Act, an allowed practitioner may 

certify, establish and periodically 

review the plan of care, as well as 

supervise the provision of items and 

services for beneficiaries under the 

Medicare home health benefit. 

Additionally, we amended the 

regulations to reflect that we would 

expect the allowed practitioner to also 

perform the face-to-face encounter for 

the patient for whom they are certifying 

eligibility; however, if a face-to-face 

encounter is performed by a physician 

or an allowed non-physician 

practitioner (NPP), as set forth in 

§ 424.22(a)(1)(v)(A), in an acute or postacute facility, from which the patient 

was directly admitted to home health, 

the certifying allowed practitioner may 

be different from the provider physician 

or allowed practitioner that performed 

the face-to-face encounter. These 

regulations text changes are not time 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35916 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

11OASIS is the instrument/data collection tool 

used to collect and report performance data by 

HHAs. 

12https://www.cms.gov/files/document/ 

certification-home-health-value-based-purchasinghhvbp-model.pdf. 

13https://innovation.cms.gov/data-and-reports/ 

2020/hhvbp-thirdann-rpt. 

14The HHVBP Third Annual Evaluation Report is 

available at https://innovation.cms.gov/data-andreports/2020/hhvbp-thirdann-rpt. 

limited to the period of the COVID–19 

PHE. 

When implementing plan of care 

changes in the CY 2021 HH PPS final 

rule (85 FR 70298), the term ‘‘allowed 

practitioner’’ was inadvertently deleted 

from the regulation text at § 409.43. 

Therefore, in this proposed rule we are 

proposing conforming regulations text 

changes at § 409.43 to reflect that 

allowed practitioners, in addition to 

physicians, may establish and 

periodically review the plan of care. 

III. Home Health Value-Based 

Purchasing (HHVBP) Model 

A. Proposal To Expand the HHVBP 

Model Nationwide 

1. Background 

As authorized by section 1115A of the 

Act and finalized in the CY 2016 HH 

PPS final rule (80 FR 68624), the CMS 

Center for Medicare and Medicaid 

Innovation (Innovation Center) 

implemented the Home Health ValueBased Purchasing Model (original 

Model) in nine States on January 1, 

2016. The last year of data collection for 

the original Model ended on December 

31, 2020. The original Model design 

leveraged the successes of and lessons 

learned from other value-based 

purchasing programs and 

demonstrations to shift from volumebased payments to a Model designed to 

promote the delivery of higher quality 

care to Medicare beneficiaries. The 

specific goals of the original Model were 

to: (1) Provide incentives for better 

quality care with greater efficiency; (2) 

study new potential quality and 

efficiency measures for appropriateness 

in the home health setting; and (3) 

enhance the current public reporting 

process. 

Using the randomized selection 

methodology finalized in the CY 2016 

HH PPS final rule, we selected nine 

States for inclusion in the original 

HHVBP Model, representing each 

geographic area across the nation. All 

Medicare-certified home health agencies 

(HHAs) providing services in Arizona, 

Florida, Iowa, Maryland, Massachusetts, 

Nebraska, North Carolina, Tennessee, 

and Washington were required to 

compete in the original Model. We 

stated that requiring all Medicarecertified HHAs in the selected States to 

participate in the Model ensures that 

there is no selection bias, participants 

are representative of HHAs nationally, 

and there would be sufficient 

participation to generate meaningful 

results. 

The original Model uses the waiver 

authority under section 1115A(d)(1) of 

the Act to adjust the Medicare payment 

amounts under section 1895(b) of the 

Act based on the competing HHAs’ 

performance on applicable quality 

measures. Under the original Model, 

CMS adjusts fee-for-service payments to 

Medicare-certified HHAs based on each 

HHA’s performance on a set of quality 

measures in a given performance year 

measured against a baseline year and 

relative to peers in its State. The 

maximum payment adjustment 

percentage increased incrementally, 

upward or downward, over the course 

of the original Model in the following 

manner: (1) 3 percent in CY 2018; (2) 5 

percent in CY 2019; (3) 6 percent in CY 

2020; (4) 7 percent in CY 2021; and (5) 

8 percent in CY 2022. Payment 

adjustments are based on each HHA’s 

Total Performance Score (TPS) in a 

given performance year, which is 

comprised of performance on: (1) A set 

of measures already reported via the 

Outcome and Assessment Information 

Set (OASIS),11 completed Home Health 

Consumer Assessment of Healthcare 

Providers and Systems (HHCAHPS) 

surveys, and claims-based measures; 

and (2) three New Measures for which 

points were achieved for reporting data. 

Payment adjustments for a given year 

are based on the TPS calculated for 

performance two years’ prior; for 

example, the CY 2018 payment 

adjustments were based on CY 2016 

performance. 

In the CY 2017 HH PPS final rule (81 

FR 76741 through 76752), CY 2018 HH 

PPS final rule (83 FR 51701 through 

51706), and CY 2019 HH PPS final rule 

(83 FR 56527 through 56547), we 

finalized changes to the original Model. 

Some of those changes included adding 

and removing measures from the 

applicable measure set, revising our 

methodology for calculating 

benchmarks and achievement 

thresholds at the State level, creating an 

appeals process for recalculation 

requests, and revising our 

methodologies for weighting measures 

and assigning improvement points. 

On January 8, 2021, we announced 

that the HHVBP Model had been 

certified for expansion nationwide,12 as 

well as our intent to expand the Model 

through notice and comment 

rulemaking beginning no sooner than 

CY 2022. The original Model has 

resulted in an average 4.6 percent 

improvement in home health agencies’ 

quality scores as well as average annual 

savings of $141 million to Medicare.13

As described in this proposed rule, 

we are proposing to expand the HHVBP 

Model (expanded Model/Model 

expansion) to all 50 States, the District 

of Columbia and the territories starting 

in CY 2022. We are proposing to codify 

HHVBP Model expansion policies at 

§§ 484.340; 484.345; 484.350; 484.355; 

484.360; 484.365; 484.370; and 484.375, 

as discussed in more detail in the 

sections that follow. 

2. Requirements for Expansion 

Section 1115A(c) of the Act provides 

the Secretary with the authority to 

expand (including implementation on a 

nationwide basis), through notice and 

comment rulemaking, the duration and 

scope of a model that is being tested 

under section 1115A(b) of the Act if the 

following findings are made, taking into 

account the evaluation of the model 

under section 1115A(b)(4) of the Act: (1) 

The Secretary determines that the 

expansion is expected to either reduce 

spending without reducing quality of 

care or improve the quality of patient 

care without increasing spending; (2) 

the CMS Chief Actuary certifies that the 

expansion would reduce (or would not 

result in any increase in) net program 

spending; and (3) the Secretary 

determines that the expansion would 

not deny or limit the coverage or 

provision of benefits. 

• Improved Quality of Care without 

Increased Spending: As observed in the 

Third Annual Evaluation Report,14 the 

HHVBP Model resulted in improved 

quality of care (for example, 

consistently increasing TPS scores) and 

a reduction in Medicare expenditures 

through three performance years of the 

HHVBP Model (CYs 2016 to 2018). The 

HHVBP Model’s intervention has led to 

savings without evidence of adverse 

risks. The evaluation also found 

reductions in unplanned acute care 

hospitalizations and skilled nursing 

facility (SNF) visits, resulting in 

reductions in inpatient and SNF 

spending. Based on these findings, the 

Secretary determined that expansion of 

the HHVBP Model would reduce 

spending and improve the quality of 

care. 

• Impact on Medicare Spending: The 

CMS Chief Actuary has certified that 

expansion of the HHVBP Model would 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35917 

15The full CMS Actuary Report is available at 

https://www.cms.gov/files/document/certificationhome-health-value-based-purchasing-hhvbpmodel.pdf. 

16HHAs are required to report OASIS data and 

any other quality measures by its own unique CMS 

Certification Number (CCN) as defined under Title 

42, Chapter IV, Subchapter G, § 484.20 Available at 

URL http://www.ecfr.gov/cgi-bin/text-idx?tpl= 

/ecfrbrowse/Title42/42cfr484_main_02.tpl. 

produce Medicare savings if expanded 

to all States.15

• No Alteration in Coverage or 

Provision of Benefits: The HHVBP 

Model did not make any changes to 

coverage or provision of benefits for 

Medicare beneficiaries. Therefore, the 

Secretary has determined that 

expansion of the HHVBP Model would 

not deny or limit the coverage or 

provision of Medicare benefits for 

Medicare beneficiaries. 

Consistent with our statutory 

authority, we would continue to test 

and evaluate the expanded HHVBP 

Model. In the future, we would assess 

whether the expanded implementation 

of HHVBP is continuing to reduce 

Medicare spending without reducing 

quality of care or to improve the quality 

of patient care without increasing 

spending, and could modify the 

expanded HHVBP Model as appropriate 

through rulemaking. 

3. Overview 

The proposed HHVBP Model 

expansion presents an opportunity to 

improve the quality of care furnished to 

Medicare beneficiaries nationwide 

through payment incentives to HHAs. If 

finalized, all Medicare-certified HHAs 

in the 50 States, District of Columbia 

and the territories would be required to 

participate in the expanded HHVBP 

Model beginning January 1, 2022. These 

HHAs would compete on value based 

on an array of quality measures related 

to the care that HHAs furnish. 

The proposed Model expansion 

would be tested under section 1115A of 

the Act. Under section 1115A(d)(1) of 

the Act, the Secretary may waive such 

requirements of Titles XI and XVIII and 

of sections 1902(a)(1), 1902(a)(13), and 

1903(m)(2)(A)(iii) of the Act as may be 

necessary solely for purposes of carrying 

out section 1115A of the Act with 

respect to testing models described in 

section 1115A(b) of the Act. The 

Secretary is not issuing any waivers of 

the fraud and abuse provisions in 

sections 1128A, 1128B, and 1877 of the 

Act or any other Medicare or Medicaid 

fraud and abuse laws for this Model 

expansion at this time. In addition, CMS 

has determined that the anti-kickback 

statute safe harbor for CMS-sponsored 

model arrangements and CMSsponsored model patient incentives (42 

CFR 1001.952(hh)(9)(ii)) will not be 

available to protect remuneration 

exchanged pursuant to any financial 

arrangements or patient incentives 

permitted under the Model. Thus, 

notwithstanding any other provisions of 

this proposed rule, all Medicarecertified HHAs in the 50 States, District 

of Columbia and the territories must 

comply with all applicable fraud and 

abuse laws and regulations. 

We are proposing to use the section 

1115A(d)(1) of the Act waiver authority 

to apply a reduction or increase of up 

to 5 percent to Medicare payments to 

Medicare-certified HHAs delivering care 

to beneficiaries in the 50 States, District 

of Columbia and the territories, 

depending on the HHA’s performance 

on specified quality measures relative to 

its peers. Specifically, the expanded 

HHVBP Model proposes to utilize the 

section 1115A(d)(1) of the Act waiver 

authority to adjust the Medicare 

payment amounts under section 1895(b) 

of the Act. In accordance with the 

authority granted to the Secretary in 

section 1115A(d)(1) of the Act, we 

would waive section 1895(b)(4) of the 

Act only to the extent necessary to 

adjust payment amounts to reflect the 

value-based payment adjustments under 

this proposed expanded Model for 

Medicare-certified HHAs in the 50 

States, District of Columbia and the 

territories. We may make changes to the 

payment adjustment percentage through 

rulemaking in future years of the 

expansion, as additional evaluation data 

from the HHVBP expanded Model 

become available, and we learn about 

performance within the Model under 

the expansion. The evaluation of the 

expanded Model would use a time 

series type approach to examine the 

outcomes of interest (cost or utilization) 

over time prior to the start of the 

intervention and follow that outcome 

after the start of the expansion. 

a. Overview of Timing and Scope 

As noted, we are proposing to begin 

the expanded HHVBP Model on January 

1, 2022. Under this proposal, CY 2022 

would be the first performance year and 

CY 2024 would be the first payment 

year, with payment adjustments in CY 

2024 based on an HHA’s performance in 

CY 2022. Performance year means the 

calendar year during which data are 

collected for the purpose of calculating 

a competing HHA’s performance on 

applicable quality measures. Payment 

year means the calendar year in which 

the applicable percent, a maximum 

upward or downward adjustment, 

applies. 

The proposed expanded Model would 

apply to all Medicare-certified HHAs in 

the 50 States, District of Columbia and 

the territories, which means that all 

Medicare-certified HHAs that provide 

services in the 50 States, District of 

Columbia and the territories would be 

required to compete in the expanded 

Model. We are proposing to codify this 

requirement at § 484.350. We are 

proposing to define a ‘competing HHA’ 

within the scope of the proposed 

expanded HHVBP Model as an HHA 

that has a current Medicare certification 

and is being paid by CMS for home 

health care services. We propose that all 

HHAs certified for participation in 

Medicare before January 1, 2021 would 

have their CY 2022 performance 

assessed and would be eligible for a CY 

2024 payment adjustment. We propose 

to base participation in the expanded 

Model on CMS Certification Numbers 

(CCNs), meaning that the Total 

Performance Score as discussed further 

in section III.A.7.a. of this proposed rule 

and payment adjustment would be 

calculated based on an HHA’s CCN.16

b. Overview of the Payment Adjustment 

As proposed, the distribution of 

payment adjustments would be based 

on quality performance, as measured by 

both achievement and improvement, 

across a proposed set of quality 

measures constructed to minimize 

burden as much as possible and 

improve care. Competing HHAs that 

demonstrate they can deliver higher 

quality of care in a given performance 

year measured against a baseline year 

relative to peers nationwide (as defined 

by larger- versus smaller-volume cohorts 

based upon their unique beneficiary 

count in the prior calendar year), could 

have their HH PPS claims final payment 

amount adjusted higher than the 

amount that otherwise would be paid. 

Competing HHAs that do not perform as 

well as other competing HHAs in the 

same volume-based cohort might have 

their HH PPS claims final payment 

amount reduced and those competing 

HHAs that perform similarly to others in 

the same volume-based cohort might 

have no payment adjustment. This 

operational concept is similar in 

practice to what is used in the Hospital 

Value-Based Purchasing (HVBP) 

Program (76 FR 26531). 

We expect that the risk of having 

payments adjusted in this manner 

would provide an incentive among all 

competing HHAs to provide 

significantly better quality through 

improved planning, coordination, and 

management of care. Under the 

expanded duration and scope of this 

Model, we would continue to examine 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35918 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

17 Detailed scoring information is contained in the 

Protocols and Guidelines manual posted on the 

HHCAHPS website and available at https://

homehealthcahps.org/Survey-and-Protocols/ 

Survey-Materials. 

18The Linear Exchange Function (LEF) is used to 

translate an HHA’s TPS into a percentage of the 

value-based payment adjustment earned by each 

HHA. For a more detailed description, please see 

section III.A.8. of this proposed rule. 

whether the proposed adjustments to 

the Medicare payment amounts that 

would otherwise be made to competing 

HHAs would result in statistically 

significant improvements in the quality 

of care being delivered to Medicare 

beneficiaries, as well as reductions in 

Medicare spending. The degree of the 

payment adjustment would be 

dependent on the level of quality 

achieved or improved from the baseline 

year, with the highest upward 

performance adjustments going to 

competing HHAs with the highest 

overall level of performance based on 

either achievement or improvement in 

quality. The size of a competing HHA’s 

payment adjustment for each year under 

the expanded Model would be 

dependent upon that HHA’s 

performance with respect to the 

applicable performance year relative to 

other competing HHAs in the same 

volume-based cohort and relative to its 

own performance during the baseline 

year. Details are discussed in sections 

III.A.4, III.A.5, and III.A.7.a of this 

proposed rule. 

In addition, at § 484.345 we propose 

to add the following definitions: 

• Achievement threshold 

• Applicable measure 

• Applicable percent 

• Baseline year 

• Benchmark 

• Competing home health agency 

• Home health prospective payment 

system 

• Improvement threshold 

• Larger-volume cohort 

• Linear exchange function 

• Nationwide 

• Payment adjustment 

• Payment year 

• Performance year 

• Smaller-volume cohort 

• Total Performance Score 

4. Defining Cohorts for Benchmarking 

and Competition 

Under the original HHVBP Model, we 

grouped HHAs into cohorts by State for 

setting benchmarks and achievement 

thresholds and by both State and 

smaller- versus larger-volume HHAs 

when determining the cohorts used for 

competing for payment adjustments, in 

accordance with § 484.330. For the 

nationwide expansion of the HHVBP 

Model, we are proposing to redefine the 

cohort structure to account for States, 

territories, and the District of Columbia 

with smaller numbers of HHAs, while 

also allowing for the use of volumebased cohorts in determining 

benchmarks, achievement thresholds, 

and payment adjustments. 

a. Proposed Smaller- and Larger-Volume 

Cohorts 

As discussed further in this section, 

we believe that separating smaller- and 

larger-volume HHAs into cohorts under 

the expanded Model would facilitate 

like comparisons by allowing for the 

majority of HHAs to receive benchmarks 

and compete for payment against other 

HHAs of similar size and based on the 

same set of measures. As under the 

original HHVBP Model, we propose to 

align the larger-volume cohort with the 

group of competing HHAs that 

administers the Home Health Care 

Consumer Assessment of Healthcare 

Providers and Systems (HHCAHPS) 

survey, in accordance with the HH QRP 

regulations concerning the HHCAHPS 

survey in § 484.245(b), and we propose 

to align the Model’s smaller-volume 

HHA cohort with the group of HHAs 

that are exempt from submitting the 

HHCAHPS survey under HH QRP under 

§ 484.245(b)(1)(iii)(A). Under the 

expanded HHVBP Model, we would not 

alter the HHCAHPS survey current 

scoring methodology or the 

participation requirements in any way. 

Details on HHCAHPS survey scoring 

methodology are available at: https://

homehealthcahps.org/Survey-andProtocols/Survey-Materials.17

The HH QRP requires, in part, that an 

HHA submit HHCAHPS survey data to 

CMS. An HHA that has fewer than 60 

eligible unique HHCAHPS survey 

patients must annually submit their 

total HHCAHPS survey patient count to 

CMS to be exempt from the HHCAHPS 

survey reporting requirements for a 

calendar year. As under the original 

HHVBP Model, we propose to align 

with this HHCAHPS survey reporting 

requirement by defining the largervolume cohort as those HHAs that are 

required to submit an HHCAHPS survey 

in the performance year. As under the 

original Model, we also propose to set 

an HHCAHPS survey measure minimum 

of at least 40 completed HHCAHPS 

surveys in the performance year for 

those HHAs to receive a score on the 

HHCAHPS survey measure, as reflected 

in proposed §§ 484.345 and 484.360. 

Accordingly, because smaller-volume 

HHAs are less likely to be assessed on 

the HHCAHPS survey measure, which 

would account for 30 percent of the 

overall performance score in the 

expanded Model, we believe that 

separating smaller- and larger-volume 

HHAs into distinct cohorts would allow 

for the majority of HHAs to compete 

against other HHAs of similar size and 

based on the same set of measures. 

b. Proposed Cohorts for the Model 

Expansion 

As discussed, we believe that 

applying separate larger- and smallervolume cohorts within the expanded 

HHVBP Model would group HHAs that 

are of similar size and are more likely 

to receive scores on the same set of 

measures for purposes of setting 

benchmarks and achievement 

thresholds and determining payment 

adjustments. However, a valid cohort 

must have a sufficient number of HHAs 

to—(1) create a robust distribution of 

Total Performance Scores, which allows 

meaningful and reasonable translation 

into payment adjustments using the 

linear exchange function (LEF);18 and 

(2) set stable, reliable benchmarks and 

achievement thresholds that are not 

heavily skewed by outliers. The LEF is 

designed so that the majority of the 

payment adjustment values fall closer to 

the median and a smaller percentage of 

HHAs receive adjustments at the higher 

and lower ends of the distribution. 

However, when only a small number of 

HHAs fall within a cohort, one HHA’s 

outlier TPS could skew the payment 

adjustments and deviate from the 

intended design of the LEF payment 

methodology. As a result, a key 

consideration in defining the cohorts is 

ensuring sufficient HHA counts within 

each cohort. 

Under the original Model, CMS 

applied a minimum of eight HHAs for 

any size cohort, such that a smallervolume cohort must have a minimum of 

eight HHAs in order for the HHAs in 

that cohort to be compared only against 

each other, and not against the HHAs in 

the larger-volume cohort (81 FR 76742). 

This policy was based on an analysis of 

the minimum number of HHAs needed 

in a smaller-volume cohort in order to 

insulate that cohort from the effect of 

outliers. Expanding the HHVBP Model 

beyond the nine mid- to large-sized 

States included in the original Model 

requires us to re-examine these cohort 

definitions because, certain territories 

and the District of Columbia would fall 

short of the original Model’s minimum 

of 8 HHAs to compose their own cohort 

even where the volume-based cohorts 

are combined. This was not an issue in 

the original Model because the nine 

selected States are relatively populous 

as compared to the smaller States, 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35919 

territories, and the District of Columbia 

that would be included in the expanded 

Model. Based on CY 2019 Home Health 

Compare Star Ratings, we evaluated the 

viability of smaller- and larger-volume 

cohorts, as defined previously, for each 

of the 55 States, territories, and the 

District of Columbia. Based on our 

analysis, of the 110 potential cohorts 

based on both State and HHA volume 

for the expanded HHVBP Model, 46 of 

the 110 potential cohorts had too few 

HHAs to reliably meet the original 

Model minimum of 8 HHAs, after 

accounting for the risk of attrition from 

the expanded Model. Under this 

approach, for 42 of these 46 States and 

territories, the smaller-volume cohorts 

would need to be combined with the 

larger-volume cohorts in their States 

and territories, while 3 territories and 

the District of Columbia would need to 

be combined with other States or 

territories since they do not meet the 8 

HHA minimum after consolidating the 

volume-based cohorts. See Table 24 for 

the counts of HHAs in each of the 

potential cohorts, if we were to apply 

separate State- and volume-based 

cohorts for each State, territory, and the 

District of Columbia under the 

expanded Model. 

BILLING CODE 4120–01–P 

BILLING CODE 4120–01–C 

As noted, under the original HHVBP 

Model, a minimum of eight HHAs is 

required for each size cohort. For the 

expanded HHVBP Model, we are 

proposing to establish cohorts 

prospectively and with sufficient HHA 

counts to prevent the need to combine 

multiple cohorts retrospectively. We 

propose to provide HHAs with their 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.036</GPH>

TABLE 24: HHA COUNTS IN STATE/TERRITORY/DISTRICT OF COLUMBIA- AND 

VOLUME-BASED COHORTS BASED ON CY 2019 HOME HEALTH CARE 

COMPARE DATA 

Large Small All Large Small All 

State HHAs HHAs HHAs State HHAs HHAs HHAs 

AK 12 1 13 MT 22 2 24 

AL 114 1 115 NC 152 4 156 

AR 90 2 92 ND 12 - 12 

AZ, 106 2 108 NE 40 8 48 

CA 993 76 1,069 NH 20 1 21 

co 105 4 109 NJ 42 - 42 

CT 74 - 74 NM 58 4 62 

DC* 7 - 7 NV 97 8 105 

DE 12 - 12 NY 105 - 105 

FL 677 54 731 OH 287 10 297 

GA 99 - 99 OK 183 10 193 

GU* 4 - 4 OR 43 1 44 

HI 14 - 14 PA 229 12 241 

IA 94 7 101 PR 33 - 33 

ID 42 1 43 RI 18 - 18 

IL 399 64 463 SC 63 - 63 

IN 138 11 149 SD 19 4 23 

KS 84 5 89 TN 112 1 113 

KY 90 - 90 TX 982 97 1,079 

LA 167 - 167 UT 68 6 74 

MA 127 5 132 VA 187 6 193 

MD 49 2 51 VI* 1 - 1 

ME 19 1 20 VT 10 - 10 

MI 322 54 376 WA 57 - 57 

MN 97 9 106 WI 73 - 73 

MO 123 9 132 WV 50 1 51 

MP* 2 - 2 WY 16 2 18 

MS 45 - 45 All 7,084 485 7,569 

*These territories and the District of Columbia fall short of the original HHVBP Model's minimum of 8 

HHAs to compose their own cohort even where the volume-based cohorts are combined. 
35920 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

applicable benchmarks and 

achievement thresholds prior to the start 

of or during the performance year so 

that they can be used to set performance 

targets to guide HHAs’ quality 

improvement projects. To reliably 

define cohorts prospectively and to 

avoid regrouping multiple States, 

territories, or the District of Columbia 

into a single cohort retrospectively 

based solely on their lower HHA counts, 

we estimate that a minimum of 20 

HHAs in each cohort would be 

necessary to ensure that attrition and 

variation in episode counts do not lead 

to insufficient HHA counts at the end of 

the performance year. Based on the data 

set forth in Table 24, 61 out of the 110 

potential cohorts would have fewer than 

20 HHAs in a size-based cohort, and 11 

out of those potential cohorts would not 

meet the 20 HHA minimum after 

combining the size-based cohorts. 

To allow for a sufficient number of 

HHAs in each volume-based cohort, for 

purposes of setting benchmarks and 

achievement thresholds and 

determining payment adjustments, we 

are proposing to use cohorts based on 

all HHAs nationwide, rather than by 

State as under the original Model. 

Referencing the CY 2019 data in Table 

24, under this approach, 7,084 HHAs 

would fall within the larger-volume 

cohort and 485 HHAs fall within the 

smaller-volume cohort. These HHA 

counts would provide a sufficiently 

large number of values in each cohort to 

allow ranking of HHA performance 

scores and payment adjustment 

percentages across the range of ¥5 

percent to +5 percent. Further, our 

analysis found that many of the smallervolume HHAs would not receive a score 

on the HHCAHPS survey measures, 

which are proposed to account for 

30percent of the overall TPS, while 

most of the larger-volume cohort HHAs 

would be scored on the full set of 

applicable measures. Accordingly, and 

as previously discussed, we believe the 

volume-based cohorts would allow for 

competition among HHAs across similar 

measures. Using nationwide rather than 

State/territory-based cohorts in 

performance comparisons would also be 

consistent with the Skilled Nursing 

Facility and Hospital VBP Programs, in 

addition to the Home Health Compare 

Star Ratings. Finally, this option would 

be the least operationally complex to 

implement. 

For the reasons discussed, we believe 

the use of nationwide smaller- and 

larger-volume-based cohorts would 

allow for appropriate groupings of 

HHAs under the expanded Model while 

also providing sufficient numbers of 

HHAs in each cohort for purposes of 

setting stable and reliable benchmarks 

and achievement thresholds and 

allowing for a robust distribution of 

payment adjustments. However, we also 

considered an alternative approach of 

using State/territory-based cohorts, 

without volume-based groupings. 

Applying the State, territory, and 

District of Columbia-level cohorts, we 

found that 11 of the 55 potential cohorts 

would have fewer than 20 HHAs based 

on the CY 2019 Home Health Star 

Ratings data. As noted, we do not 

believe this would allow for a sufficient 

number of HHAs to develop prospective 

benchmarks and achievement 

thresholds. While one approach would 

be to exclude any States, territories, or 

the District of Columbia from the 

expanded Model for years in which 

there are fewer than 20 HHAs in the 

cohort, we believe such a policy would 

be inconsistent with the goal of 

including all eligible HHAs nationwide 

in the Model. Another option would be 

to consolidate those States, territories, 

and the District of Columbia with less 

than 20 HHAs in the cohort, and to 

calculate benchmarks, achievement 

thresholds, and payment adjustments 

based on that consolidated grouping of 

HHAs. We note that while slight 

differences do exist between quality 

measure scores based on geographic 

location, we do not believe that 

codifying these small differences into 

long-term performance standards is 

necessary to appropriately determine 

payment adjustments under the 

expanded Model. 

We are proposing to establish 

nationwide volume-based cohorts for 

the expanded HHVBP Model, such that 

HHAs nationwide would compete 

within either the larger-volume cohort 

or the smaller-volume cohort. We 

propose to codify this policy at 

§ 484.370, and to codify the proposed 

definitions of smaller-volume cohort 

and larger-volume cohort at § 484.345. 

Under this proposal, HHAs currently 

participating in the original HHVBP 

Model would no longer compete within 

just their State. We are also requesting 

comment on the alternative approach of 

applying State/territory-based cohorts 

only, without volume-based cohorts, 

which we may finalize after 

consideration of comments received. 

We seek public comment on these 

proposals. 

5. Proposed Payment Adjustment 

Percentage and Performance Assessment 

and Payment Adjustment Periods 

a. Proposed Payment Adjustment 

Under the original Model, the 

payment adjustment ranges from a 

minimum of 3 percent in 2018 to 

maximum of 8 percent in 2022. For the 

expanded Model, we are proposing that 

the maximum payment adjustment, 

upward or downward, would be 5 

percent. We believe that beginning the 

expansion with a 5 percent maximum 

payment adjustment would strike a 

balance between the 3 percent 

maximum adjustment that applied for 

CY 2018, the first payment year of the 

original HHVBP Model, and the 7 

percent maximum adjustment currently 

in place for CY 2021. As proposed in 

section III.A.3.a. of this proposed rule, 

the first payment year of the expanded 

HHVBP Model would be CY 2024 

(January 1, 2024 through December 31, 

2024), with payment adjustments based 

on performance in CY 2022 (January 1, 

2022 through December 31, 2022). We 

may consider changes to the proposed 5 

percent maximum payment adjustment 

percentage through rulemaking in future 

years of the expansion, as additional 

evaluation data from the original Model 

and expansion become available. We 

note that the CMS Actuary certification 

was based on evaluation of the Model 

when the maximum payment 

adjustment was 3 percent. However, in 

their certification memo, they indicated 

they believe the Model would result in 

savings at higher payment adjustment 

amounts as well. 

We seek public comment on the 

proposed payment adjustment 

percentage. 

b. Proposed Baseline Year 

(1) General 

For the expanded HHVBP Model, due 

to the potentially de-stabilizing effects 

of the COVID–19 public health 

emergency (PHE) on quality measure 

data in CY 2020, we propose that the 

baseline year would be CY 2019 

(January 1, 2019 through December 31, 

2019) for the CY 2022 performance year/ 

CY 2024 payment year and subsequent 

years. The data from this baseline year 

would provide a basis from which each 

respective HHA’s performance would be 

measured for purposes of calculating 

achievement and improvement points 

under the expanded Model. We may 

propose to update the baseline year for 

subsequent years of the expanded 

Model through future rulemaking. We 

would also propose the applicable 

baseline year for any additional quality 

measures that may be added to the 

measure set for the expanded HHVBP 

Model through future rulemaking. 

We seek public comment on the 

proposed baseline year for the expanded 

Model. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35921 

19https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/ValueBased-Programs/CMS-Quality-Strategy. 

20For NQF endorsed measures see The NQF 

Quality Positioning System available at http://

www.qualityforum.org/QPS. For non-NQF measures 

using OASIS see links for data tables related to 

OASIS measures at https://www.cms.gov/Medicare/ 

Quality-Initiatives-Patient-Assessment-Instruments/ 

HomeHealthQualityInits. 

(2) New HHAs 

As noted, we are generally proposing 

that for the expanded Model, the 

baseline year would be CY 2019 

(January 1, 2019 through December 31, 

2019) for the CY 2022 performance year/ 

CY 2024 payment year and subsequent 

years. For new HHAs, specifically those 

HHAs that are certified by Medicare on 

or after January 1, 2019, we are 

proposing that the baseline year under 

the expanded Model would be the 

HHA’s first full CY of services beginning 

after the date of Medicare certification, 

with the exception of HHAs certified on 

January 1, 2019 through December 31, 

2019, for which the baseline year would 

be CY 2021. Furthermore, we propose 

that new HHAs would begin competing 

under the expanded HHVBP Model in 

the first full calendar year following the 

full calendar year baseline year. For 

example, and as previously discussed, 

we are proposing that all HHAs certified 

for participation in Medicare before 

January 1, 2021 would have their CY 

2022 performance assessed and would 

be eligible for a CY 2024 payment 

adjustment. For HHAs certified on 

January 1, 2020 through December 31, 

2020, the baseline year would be CY 

2021, the first full CY of services 

beginning after the date of Medicare 

certification. For those HHAs certified 

on January 1, 2019 through December 

31, 2019, the baseline year would also 

be CY 2021, rather than CY 2020 (the 

first full CY of services beginning after 

the date of Medicare certification), due 

to the potentially destabilizing effects of 

the PHE on quality measure data in CY 

2020. For an HHA certified by Medicare 

on January 1, 2021 through December 

31, 2021, for example, the first full 

calendar year of services that would 

establish the HHA’s baseline year would 

be CY 2022. The HHA’s first 

performance year would be CY 2023 

and the HHA’s first payment year, based 

on CY 2023 performance, would be CY 

2025. Table 25 shows the proposed 

HHA baseline, performance and 

payment years based on the HHA’s 

Medicare-certification date through 

December 31, 2021. 

We also propose to codify our 

proposal on new HHAs at § 484.350. We 

seek public comment on this proposal. 

6. Quality Measures 

a. General Considerations Used for the 

Selection of Quality Measures for the 

Expanded HHVBP Model 

We plan to apply, to the extent 

possible, principles from CMS’ 

Meaningful Measures Initiative in 

selecting the applicable measures as 

defined at § 484.345 to be included in 

the Model expansion. A central driver of 

the proposed applicable measure set is 

to have a broad, high impact on care 

delivery and support priorities to 

improve health outcomes, quality, 

safety, efficiency, and experience of care 

for patients. To frame the selection 

process, we also considered the 

domains of the CMS Quality Strategy 19

that maps to the six National Quality 

Strategy (NQS) 20 priority areas: Clinical 

quality of care; Care coordination; 

Population/community health; 

efficiency and cost reduction; safety; 

and, Patient and caregiver-centered 

experience. 

We believe that Medicare-certified 

HHAs should be evaluated using 

measures designed to encompass 

multiple NQS domains, and provide 

future flexibility to incorporate and 

study newly developed measures over 

time. Additionally, so that measures for 

the expanded HHVBP Model take a 

more holistic view of the patient beyond 

a particular disease, functional status, 

State or care setting, we would prioritize 

outcome measures that have the 

potential to follow patients across 

multiple settings, reflect a multi-faceted 

approach, and foster the intersection of 

health care delivery and population 

health. 

The proposed expanded Model 

measures mostly align with those under 

the HH QRP. However, we intend to 

consider new measures for inclusion in 

subsequent years of the expanded 

HHVBP Model through future 

rulemaking. We may consider adding 

new measures to the expanded HHVBP 

Model measure set that address gaps 

within the NQS domains or the home 

health service line and are good 

indicators of home health quality of 

care. When available, NQF endorsed 

measures would be used. The expanded 

Model’s section 1115A of the Act 

authority also affords the opportunity to 

study other measures, such as, measures 

developed in other care settings or new 

to the home health industry, should 

CMS identify such measures. A key 

consideration behind this approach is to 

use measures that are readily available, 

and, in subsequent Model years, 

augment the applicable measure set 

with innovative measures that have the 

potential to be impactful and fill critical 

measure gap areas. This approach to 

quality measure selection aims to 

balance the burden of collecting data 

with the inclusion of new and important 

measures. We would carefully consider 

the potential burden on HHAs to report 

the measure data that is not already 

collected through existing quality 

measure data reporting systems and 

reiterate that we would propose any 

new measures through future 

rulemaking. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.037</GPH>

TABLE 25: PROPOSED HHA BASELINE, PERFORMANCE AND PAYMENT 

YEAR BASED ON MEDICARE-CERTIFICATION DATE 

THROUGH DECEMBER 31, 2021 

Medicare-certification Date Baseline Performance Payment 

Year Year Year 

Prior to January 1, 2019 2019 2022 2024 

On Januarv 1, 2019 - December 31, 2019 2021 2022 2024 

On J anuarv 1, 2020 - December 31, 2020 2021 2022 2024 

On J anuarv 1, 2021 - December 31, 2021 2022 2023 2025 
35922 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

b. Proposed Measure Set Beginning 

With the CY 2022 Performance Year/CY 

2024 Payment Year and Subsequent 

Years 

We propose that the initial applicable 

measure set for the expanded HHVBP 

Model for the CY 2022 performance year 

focus on patient outcome and functional 

status, utilization, and patient 

experience. The proposed measures 

were also used under the original Model 

(83 FR 56533). However, we note that 

no ‘‘New Measures’’ as defined in the 

original Model (80 FR 68674) are being 

proposed for data collection under the 

expanded Model beginning with the CY 

2022 performance year given there was 

sufficient data collected on the ‘‘New 

Measures’’ under the original Model for 

analysis of the appropriateness for use 

in the home health setting. We note that 

any future additional measures 

proposed for the expanded HHVBP 

Model would not be considered ‘‘New 

Measures’’ as used in the original 

Model. 

Beginning with the CY 2022 

performance year/CY 2024 payment 

year and for subsequent years, we 

propose the following measures as 

detailed in Table 26 for inclusion in the 

expanded Model. The measure set also 

includes outcome measures, which 

illustrate the end result of care delivered 

to HHA patients and address an 

important quality aim for HHA patients. 

We believe the proposed measure set 

under the expanded HHVBP Model, 

where most measures currently align 

with HH QRP measures, supports 

enhancing quality because of the valuebased incentives provided under the 

expanded Model. Further, we believe 

that the expanded Model measure set, as 

proposed, includes an array of measures 

that would capture the care that HHAs 

furnish and incentivize quality 

improvement. The measures in the 

proposed measure set are divided into 

measure categories based on their data 

source as indicated in Table 26: Claimsbased, OASIS-based, and the HHCAHPS 

survey-based. We note that the 

HHCAHPS survey-based measure has 

five individual components. The term 

‘‘applicable measure’’ applies to each of 

the five components for which a 

competing HHA has submitted a 

minimum of 40 completed HHCAHPS 

surveys (This is discussed in more 

detail in sections III.A.4.a., III.A.7.c., 

and III.A.7.d. of this proposed rule). 

That is, each component counts as one 

applicable measure towards the five 

measure minimum that is required for 

an HHA to receive a Total Performance 

Score (TPS) (this is discussed in more 

detail in section III.A.7.d of this 

proposed rule). 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2

EP07JY21.038</GPH>khammond on DSKJM1Z7X2PROD with PROPOSALS2

TABLE 26: PROPOSED MEASURE SET FOR THE EXPANDED HHVBP MOD

(Beginning with the CY 2022 Performance Year/CY 2024 Payment Year and Subsequen

Measure Full 

Title/Short Form Measure Measure Data 

NQS Domains Name (ifaoolicable) Tvoe Steward Identifier Source Numerator Denominator 

OASIS-based 

Clinical Quality of Care Improvement in Outcome NA NA OASIS Number of home Number of home healt

Dyspnea/Dyspnea (Ml400) health episodes of episodes of care ending 

care where the with a discharge during 

discharge assessment the reporting period, 

indicates less other than those covere

dyspnea at discharge by generic or measure- 

than at start ( or specific exclusions. 

resumption) of care. 

Communication & Care Discharged to Outcome NA NA OASIS Number of home Number of home healt

Coordination Community (M2420) health episodes episodes of care ending 

where the assessment with discharge or trans

completed at the to inpatient facility 

discharge indicates during the reporting 

the patient remained period, other than thos

in the community covered by generic or 

after discharge. measure-specific 

exclusions. 

Patient Safety Improvement in Outcome CMS NQF0176 OASIS Number of home Number of home healt

Management of Oral (M2020) health episodes of episodes of care ending 

Medications/Oral care where the value with a discharge during 

Medication recorded on the the reporting period, 

discharge assessment other than those covere

indicates less by generic or measure- 

impairment in taking specific exclusions. 

oral medications correctly at discharge 

than at start ( or 

resumntion) of care. 

Patient and Family Total Normalized Composite NA NA OASIS The total normalized A prediction model is 

Engagement Composite Change in Outcome (M1840) change in mobility computed at the episod

Mobility* /TNC (M1850) functioning across level. The predicted 

Mobility (M1860) three OASIS items value for the HHA and 

(toilet transferring, the national value of th

bed transferring, and predicted values are 

ambulation/locomoti calculated and are used 

on) calculate the risk-adjus

rate for the HHA, whic

is calculated using this 

formula: HHA Risk 

Adjusted = HHA 

Observed+ National 

Predicted - HHA 

Predicted. 
Table 27 provides more granular 

detail on the elements of the Home 

Health Care Consumer Assessment of Healthcare Providers and Systems 

(HHCAHPS) Survey measure. 


EP07JY21.039</GPH>khammond on DSKJM1Z7X2PROD with PROPOSALS2

Measure Full 

Title/Short Fonn Measure Measure Data 

NQS Domains Name (if applicable) Type Steward Identifier Source Numerator Denominator 

Patient and Family Total Normalized Composite NA NA OASIS The total normalized A prediction model is 

Engagement Composite Change in Outcome (Ml800) change in self-care computed at the episod

Self-Care**/TNC (Ml8IO) functioning across level. The predicted va

Self-Care (Ml820) six OASIS items for the HHA and the 

(Ml830) (grooming, bathing, national value of the (Ml845) upper & lower body predicted values are (Ml870) dressing, toilet calculated and are used 

hygiene, and eating) calculate the risk-adjus

rate for the HHA, whic

is calculated using this 

formula: HHA Risk 

Adjusted = HHA 

Observed+ National 

Predicted - HHA Predicted. 

Claims-based 

Efficiency & Cost Acute Care Outcome CMS NQF 0171 ccw Number of home Number of home healt

Reduction Hospitalization (Claims) health stays for stays that begin during 

During the First 60 patients who have a the 12-month observat

Days of Home Health Medicare claim for period. A home health 

Use/ACH an unplanned stay is a sequence of 

admission to an acute home health payment 

care hospital in the episodes separated from 

60 days following the other home health 

start of the home payment episodes by a

health stay. least 60 days. 

Efficiency & Cost Emergency Outcome CMS NQF0173 ccw Number of home Number of home healt

Reduction Department Use (Claims) health stays for stays that begin during 

without patients who have a the 12-month observat

Hospitalization Medicare claim for period. A home health 

During the First 60 outpatient emergency stay is a sequence of 

DaysofHome department use and home health payment 

Health/ED Use no claims for acute episodes separated from 

care hospitalization other home health 

in the 60 days payment episodes by a

following the start of least 60 days. 

the home health stav. 

HHCAHPS Survey-based 

Patient & Caregiver- Home Health Outcome CMS NQF 0517 CARPS Survey-based. Survey-based. 

Centered Experience Consumer HHCAHPS has five HHCAHPS has five 

Assessment component questions component questions th

Healthcare Providers that together are used together are used to 

and Systems to represent one represent one NQF-

(HHCAHPS) Survey NQF-endorsed endorsed measure 

measure 

*Because the Total Normalized Composite Change in Mobility measure is a composite measure rather than simply an outcome measure, the terms "Numerator" a

* *Because the Total Normalized Composite Change in Self-Care measure is a composite measure rather than simply an outcome measure, the terms "Numerator

EP07JY21.040</GPH>khammond on DSKJM1Z7X2PROD with PROPOSALS2

TABLE 27: HHCAHPS SURVEY MEASURE COMPONENTS 

AND COMPONENT QUESTIONS 

HHCAHPS SuITey-based* Component Name/ Short Name and Type NQFID Data Link to Comp

ComnonentOuestion Source Catee:ories 

Care of Patients/Professional Care Outcome 0517 CAHPS htt12s://cmit.cm

ure?Measureid

Q9. In the last 2 months of care, how often did home health providers from this agency seem informed and up- Never, Sometim

to-date about all the care or treatment vou got at home? 

Q16. In the last 2 months of care, how often did home health providers from this agency treat you as gently as Never, Sometim

possible? 

Q19. In the last 2 months of care, how often did home health providers from this agency treat you with courtesy Never, Sometim

and respect? 

024. In the last 2 months of care, did you have any problems with the care you got through this agency? Yes,No 

Communications between Providers and Patients/Communication Outcome 0517 CAHPS h!ms://cmit.cm

ure?Measureid

Q2. When you first started getting home health care from this agency, did someone from the agency tell you Yes,No 

what care and services you would get? 

Q15. In the past 2 months of care, how often did home health providers from this agency keep you informed Never, Sometim

about when they would arrive at your home? 

Ql 7. In the past 2 months of care, how often did home health providers from this agency explain things in a Never, Sometim

wav that was easy to understand? 

Q18. In the past 2 months of care, how often did home health providers from this agency listen carefully to you? Never, SometimQ22. In the past 2 months of care, when you contacted this agency's office did you get the help or advice you Yes,No 

needed? 

Q23. When you contacted this agency's office, how long did it take for you to get the help or advice you Same day; 1 to 

needed? than 14 days 

Specific Care Issues/Team Discussion Outcome 0517 CAHPS h!ms://cmit.cm

ure?Measureid

Q3. When you first started getting home health care from this agency, did someone from the agency talk with Yes,No 

you about how to set up your home so you can move around safely? 

Q4. When you started getting home health care from this agency, did someone from the agency talk with you Yes,No 

about all the prescription medicines you are taking? 

Q5. When you started getting home health care from this agency, did someone from the agency ask to see all Yes,No 

the prescription medicines you were taking? 

010. In the past 2 months of care, did you and a home health provider from this agency talk about ooin? Yes,No 

Q12. In the past 2 months of care, did home health providers from this agency talk with you about the purpose Yes,No 

for taking vour new or changed mescriPtion medicines? 

Q13. In the last 2 months of care, did home health providers from this agency talk with you about when to take Yes,No 

these medicines? 

Q14. In the last 2 months of care, did home health providers from this agency talk with you about the Yes,No 

important side effects of these medicines? 

EP07JY21.041</GPH>khammond on DSKJM1Z7X2PROD with PROPOSALS2

Overall rating of home health care/Overall Rating I Outcome I 0517 I CAHPS htms://cmit.cms

ure?Measureld=

Q20. What number would you use to rate your care from this agency's home health providers? Use a rating sca

best) 

Willingness to recommend the agency/Willing to Recommend I Outcome I 0517 I CAHPS htms://cmit.cms

ure?Measureid=

Q25. Would you recommend this agency to your family or friends if they needed home health care? Definitely no; P

Definitelv ves 

*The HHCAHPS has five component questions that together are used to represent one NQF-endorsed measure. Detailed scorin

Protocols and Guidelines manual posted on the HHCAHPS website and available at https://homehelathcahns.org/Survey-and-Protocols/Surv
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35927 

21https://homehealthcahps.org/GeneralInformation/About-Home-Health-Care-CAHPSSurvey. 

BILLING CODE 4120–01–C 

(1) Additional Background on the Total 

Normalized Composite Measures 

The proposed measure set includes 

two composite measures: Total 

Normalized Composite (TNC) Self-Care 

and TNC Mobility, which were included 

in the original HHVBP Model measure 

set in CY 2019, as finalized in the CY 

2019 HH PPS final rule (83 FR 56529 

through 56535). The methodology for 

these measures take into account 

patients who may not have goals for 

improvement. 

The proposed TNC Self-Care measure 

computes the magnitude of change, 

either positive or negative, based on a 

normalized amount of possible change 

on each of six OASIS-based quality 

outcomes. These six outcomes are as 

follows: 

• Improvement in Grooming (M1800) 

• Improvement in Upper Body Dressing 

(M1810) 

• Improvement in Lower Body Dressing 

(M1820) 

• Improvement in Bathing (M1830) 

• Improvement in Toileting Hygiene 

(M1845) 

• Improvement in Eating (M1870) 

The TNC Mobility measure computes 

the magnitude of change, either positive 

or negative, based on the normalized 

amount of possible change on each of 

three OASIS-based quality outcomes. 

These three outcomes are as follows: 

• Improvement in Toilet Transferring 

(M1840) 

• Improvement in Bed Transferring 

(M1850) 

• Improvement in Ambulation/ 

Locomotion (M1860) 

For each TNC measure, we calculate 

at the episode level and then aggregate 

to the home health agency level using a 

five-step process: Steps 1 to 3 calculate 

the normalized change values for each 

applicable OASIS item at the episode 

level. Steps 4 and 5 aggregate these 

values to the agency level. As composite 

measures, the TNC Self-Care and TNC 

Mobility measures reflect multiple 

OASIS items, so there are no numerators 

or denominators for these two measures. 

A detailed description of the five steps 

can be found at: https://www.hhs.gov/

guidance/sites/default/files/hhsguidance-documents/hhvbp

%20computing%20the%20hhvbp

%20composite%20measures.pdf. We 

expect that HHAs already focus on 

improvement in such areas not just 

because such items are included in the 

OASIS, but because self-care and 

mobility are areas of great importance to 

patients and families. Improvement in 

such areas may allow beneficiaries to 

remain in the home setting (versus an 

institution) and contribute to 

beneficiaries’ quality of life. The risk 

adjustment methodology for these two 

measures recalibrates the expectations 

for improvement by including risk 

factors for a wide variety of beneficiarylevel factors, including age, risk for 

hospitalization, condition categories, 

living arrangements and caregivers 

available, pain, cognitive function, 

baseline functional status, and others. 

For instance, a beneficiary with 

impaired cognition would not be 

expected to improve in self-care as 

much as a beneficiary with intact 

cognition. In effect, the self-care 

improvement score would shift up 

slightly for a beneficiary with impaired 

cognition relative to a beneficiary 

without cognitive impairment to 

account for the difference in 

expectations. Both TNC measures’ 

computations can be found at https://

www.hhs.gov/guidance/sites/default/

files/hhs-guidance-documents/hhvbp

%20computing%20the%20hhvbp

%20composite%20measures.pdf and 

the technical specifications can be 

found at: https://www.hhs.gov/

guidance/sites/default/files/hhsguidance-documents/hhvbp

%20technical%20specification

%20resource%20for%20composite

%20outcome%20measures_4.pdf. 

Additional information on the 

predictive modeling and methodology 

for the composite measures can be 

found in the CY 2019 HH PPS final rule 

(83 FR 56529 through 56535). 

We note that we had considered the 

inclusion of stabilization measures 

which are measures that identify all 

patients whose function has not 

declined, including both those who 

have improved or stayed the same in the 

original HHVBP Model’s measure set 

and refer readers to the CY 2016 HH 

PPS final rule (80 FR 68669 through 

68670) and the CY 2019 HH PPS final 

rule (83 FR 56529 through 56535). In the 

CY 2016 final rule, we explained that 

we considered using some of the 

stabilization measures for the original 

Model and found that the average HHA 

stabilization measure scores ranged 

from 94 to 96 percent and, with average 

rates of nearly 100 percent. We do not 

believe these high measure scores 

would allow for meaningful 

comparisons between competing-HHAs 

on the quality of care delivered. We 

acknowledge that skilled care may be 

necessary to improve a patient’s current 

condition, to maintain the patient’s 

current condition, or to prevent or slow 

further deterioration of the patient’s 

condition. However, we believe that the 

two proposed TNC measures represent a 

new direction in how quality of patient 

care is measured in home health as 

patients who receive care from an HHA 

may have functional limitations and 

may be at risk for further decline in 

function because of limited mobility 

and ambulation. 

(2) Additional Background on the Home 

Health Care Consumer Assessment of 

Healthcare Providers and Systems 

Survey Measure 

The Home Health Care Consumer 

Assessment of Healthcare Providers and 

Systems Survey (HHCAHPS) survey is 

part of a family of CAHPS® surveys that 

asks patients to report on and rate their 

experiences with health care. The 

HHCAHPS survey specifically presents 

home health patients with a set of 

standardized questions about their 

home health care providers and about 

the quality of their home health care. 

The survey is designed to measure the 

experiences of people receiving home 

health care from Medicare-certified 

home health care agencies and meet the 

following three broad goals to: (1) 

Produce comparable data on the 

patient’s perspective that allows 

objective and meaningful comparisons 

between HHAs on domains that are 

important to consumers; (2) create 

incentives through public reporting of 

survey results for agencies to improve 

their quality of care; and (3) enhance 

public accountability in health care by 

increasing the transparency of the 

quality of care provided in return for 

public investment through public 

reporting.21

We note that the HHCAHPS survey is 

also part of the HH QRP’s data 

submission requirements, which are 

codified for that program at 42 CFR 

484.245(b). As proposed, expanded 

HHVBP Model participants would not 

need to submit separate HHCAHPS 

survey measure data already submitted 

as a requirement under HH QRP, 

because the requirements as proposed 

for the expanded Model are aligned 

with those currently under HH QRP. For 

more details about the HHCAHPS 

Survey, please see https://homehealth

cahps.org/. 

We invite public comment on our 

proposed measure set. 

c. Measure Modifications 

During the expanded Model, we 

would monitor the quality measures for 

lessons learned and address any needed 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35928 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

adjustments or modifications to the 

expanded Model measure set. 

(1) Proposed Substantive vs. NonSubstantive Changes Policy 

Updates to measures may result from 

various sources including, for example, 

measure stewards and owners, new 

clinical guidelines, a public health 

emergency, CMS-identified, a technical 

expert panel (TEP), or NQF. How we 

incorporate those updates would 

depend on whether the changes are 

substantive or non-substantive. 

With respect to what constitutes a 

substantive versus a non-substantive 

change, we expect to make this 

determination on a measure-by-measure 

basis. Examples of such non-substantive 

changes might include updated 

diagnosis or procedure codes, 

medication updates for categories of 

medications, broadening of age ranges, 

and changes to exclusions for a 

measure. We believe that nonsubstantive changes may include 

updates to measures based upon 

changes to guidelines upon which the 

measures are based. These types of 

maintenance changes are distinct from 

more substantive changes to measures 

that result in what can be considered 

new or different measures, and that they 

do not trigger the same agency 

obligations under the Administrative 

Procedure Act. 

We propose that, in the event that an 

update to a measure is necessary in a 

manner that we consider to not 

substantially change the nature of the 

measure, we will use a sub-regulatory 

process to incorporate those updates to 

the measure specifications. Specifically, 

we would revise the information that is 

posted on the CMS website so that it 

clearly identifies the updates and 

provides links to where additional 

information on the updates can be 

found. In addition, we would provide 

sufficient lead time for HHAs to 

implement the changes where changes 

to the data collection systems would be 

necessary. 

We are also proposing to use notice 

and comment rulemaking to adopt 

changes to measures that we consider to 

substantially change the nature of the 

measure. Examples of changes that we 

might consider to be substantive would 

be those in which the changes are so 

significant that the measure is no longer 

the same measure, or when a standard 

of performance assessed by a measure 

becomes more stringent, such as 

changes in acceptable timing of 

medication, procedure/process, test 

administration, or expansion of the 

measure to a new setting. We believe 

that our proposal adequately balances 

the need to incorporate changes to 

measures used in the expanded HHVBP 

Model in the most expeditious manner 

possible, while preserving the public’s 

ability to comment on updates to 

measures that so fundamentally change 

a measure that it is no longer the same 

measure originally adopted. We note 

that CMS adopted a similar policy for 

the HH QRP in the CY 2015 HH PPS 

final rule (79 FR 66079 through 66081). 

We invite public comment on our 

proposal. 

d. Measure Removals 

The measure set used for the 

expanded Model would be subject to 

change including the removal of 

measures during subsequent years. In 

this proposed rule, for greater 

transparency, we propose factors we 

would consider in proposing to remove 

a measure as well as a policy for when 

immediate suspension is necessary. 

(1) Proposed Removal Factors 

We propose to generally use the 

below removal factors when considering 

a quality measure for removal for use in 

the expanded HHVBP Model: 

• Factor 1. Measure performance 

among HHAs is so high and unvarying 

that meaningful distinctions in 

improvements in performance can no 

longer be made (that is, topped out). To 

determine ‘‘topped-out’’ criteria, we will 

calculate the top distribution of HHA 

performance on each measure, and if the 

75th and 90th percentiles are 

statistically indistinguishable, we will 

consider the measure topped-out. 

• Factor 2. Performance or 

improvement on a measure does not 

result in better patient outcomes. 

• Factor 3. A measure does not align 

with current clinical guidelines or 

practice. 

• Factor 4. A more broadly applicable 

measure (across settings, populations, or 

conditions) for the particular topic is 

available. 

• Factor 5. A measure that is more 

proximal in time to desired patient 

outcomes for the particular topic is 

available. 

• Factor 6. A measure that is more 

strongly associated with desired patient 

outcomes for the particular topic is 

available. 

• Factor 7. Collection or public 

reporting of a measure leads to negative 

unintended consequences other than 

patient harm. 

• Factor 8. The costs associated with 

a measure outweigh the benefit of its 

continued use in the program. 

With respect to Factor 8, under our 

Meaningful Measures Initiative, we are 

engaging in efforts to ensure that the 

expanded HHVBP Model measure set 

continues to promote improved health 

outcomes for beneficiaries while 

minimizing the overall costs associated 

with the program. We believe that these 

costs are multifaceted and include not 

only the burden associated with 

reporting, but also the costs associated 

with implementing and maintaining the 

expanded HHVBP Model. We have 

identified several different types of 

costs, including, but not limited to the 

following: 

• Provider and clinician information 

collection burden and burden associated 

with the submitting/reporting of quality 

measures to CMS. 

• The provider and clinician cost 

associated with complying with other 

HH programmatic requirements. 

• The provider and clinician cost 

associated with participating in 

multiple quality programs, and tracking 

multiple similar or duplicative 

measures within or across those 

programs. 

• The cost to CMS associated with the 

program oversight of the measure, 

including measure maintenance and 

public display. 

• The provider and clinician cost 

associated with compliance with other 

Federal and State regulations (if 

applicable). 

For example, it may be of limited 

benefit to retain or maintain a measure 

which our analyses show no longer 

meaningfully supports the expanded 

HHVBP Model goals (for example, no 

longer provides incentives for better 

quality care with greater efficiency). It 

may also be costly for HHAs to track 

confidential feedback and publicly 

reported information on a measure 

where we use the measure in more than 

one initiative, model, or program. We 

may also have to expend resources to 

maintain the specifications for the 

measure, including the tools needed to 

collect, validate, analyze, and publicly 

report the measure data. 

When these costs outweigh the 

evidence supporting the continued use 

of a measure in the expanded HHVBP 

Model, we believe that it may be 

appropriate to remove the measure from 

the Model. Although we recognize that 

the expanded HHVBP Model is to 

encourage HHAs to improve beneficiary 

outcomes by incentivizing health care 

providers, we also recognize that this 

can have limited utility where, for 

example, the data is of limited use 

because it is not meaningful. In these 

cases, removing the measure from the 

expanded HHVBP Model may better 

accommodate the costs of expansion 

administration and compliance without 

sacrificing improved health outcomes. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35929 

22For detailed information on OASIS see the 

official CMS web resource available at https://

www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/HomeHealthQualityInits. 

23For detailed information on OASIS see the 

official CMS web resource available at https://

www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/HomeHealthQualityInits. 

We propose that we would remove 

measures based on Factor 8 on a caseby-case basis. For example, we may 

decide to retain a measure that is 

burdensome for HHAs to report if we 

conclude that the benefit to 

beneficiaries is so high that it justifies 

the reporting burden. Our goal is to 

move the expanded HHVBP Model 

forward in the least burdensome manner 

possible, while maintaining a 

parsimonious set of meaningful quality 

measures and continuing to incentivize 

improvement in the quality of care 

provided to patients. 

We believe that even if one or more 

of the measure removal factors applies, 

we might nonetheless choose to retain 

the measure for certain specified 

reasons. Examples of such instances 

could include when a particular 

measure addresses a gap in quality that 

is so significant that removing the 

measure could result in poor quality. 

We would apply these factors on a caseby-case basis. 

In addition, as noted previously, the 

authority to expand the HHVBP Model 

affords the opportunity to study new 

measures that are not currently 

collected or submitted to CMS by HHAs. 

Because of this, there may be other 

unforeseen reasons that necessitates the 

removal of a measure that is not 

currently captured in one of the factors 

noted previously. In such cases, we 

would still use notice and comment 

rulemaking to remove the measure and 

provide the reasons for doing so. 

We seek public comment on our 

proposals. 

(2) Proposed Measure Suspension 

Policy 

Removal of an expanded HHVBP 

Model measure would take place 

through notice and comment 

rulemaking as proposed above unless 

we determine that a measure is causing 

concern for patient safety or harm. We 

propose that in the case of an expanded 

HHVBP Model measure for which there 

is a reason to believe that the continued 

collection raises possible patient safety 

concerns, we would promptly suspend 

the measure and immediately notify 

HHAs and the public through the usual 

communication channels, including 

listening sessions, memos, email 

notification, and Web postings. We 

would then propose to remove or 

modify the measure as appropriate 

during the next rulemaking cycle. 

We request public comment on our 

proposal. 

e. Future Topics or Measure 

Considerations 

(1) Consideration To Align or Remove 

Measures With the HH QRP 

We note that in section IV.C. of this 

proposed rule, the CMS proposes to 

replace the Acute Care Hospitalization 

During the First 60 Days of Home Health 

(ACH) measure and Emergency 

Department Use Without 

Hospitalization During the First 60 days 

of Home Health (ED Use) measure with 

the Home Health Within-Stay 

Potentially Preventable Hospitalization 

(PPH) for the HH QRP measure 

beginning with the CY 2023 under the 

in the HH QRP. We note that while both 

the ACH and ED Use measure are being 

proposed for removal under the HH 

QRP, these measures are being proposed 

for inclusion in the expanded HHVBP 

Model beginning with the CY 2022 

performance year. We seek public 

comment on whether we should instead 

align the expanded HHVBP Model with 

the proposed changes for HH QRP by 

proposing to remove the same two 

measures from the expanded Model in 

a future year. We note that any measure 

removals would be proposed in future 

notice and comment rulemaking. 

We request public feedback on this 

future consideration. 

(2) Health Equity Considerations for the 

Expanded HHVBP Model 

In section VIII.B. of this proposed 

rule, we include a Request for 

Information on ways to close the health 

equity gap in post-acute care quality 

reporting programs, including the HH 

QRP. We refer readers to that section for 

discussion of our current health equity 

efforts in quality measurement and 

reporting and potential modifications 

we have considered or may consider in 

the future. However, in recognition of 

persistent health disparities and the 

importance of closing the health equity 

gap, we request public comment on 

ways in which we could incorporate 

health equity goals and principles into 

the expanded HHVBP Model. 

Specifically, we seek comment on the 

challenges unique to value-based 

purchasing frameworks in terms of 

promoting health equity, and ways in 

which we could incorporate health 

equity goals into the expanded HHVBP 

Model. 

f. Measure Submissions—Form, 

Manner, and Timing 

We propose at § 484.355 that home 

health agencies will be evaluated using 

a set of quality measures, and data 

submitted under the expanded Model 

must be submitted in the form and 

manner, and at a time, specified by 

CMS. Additional details regarding 

specific types of measures are discussed 

later in this section. 

As noted previously, the expanded 

HHVBP Model measures in the 

proposed measure set beginning with 

the CY 2022 performance year would 

use data currently already reported by 

HHAs. The proposed measure set 

includes OASIS 22 measures, submitted 

through the OASIS assessment, which is 

required to be submitted as part of the 

Medicare Conditions of Participation 

(CoPs), the HHCAHPS survey measure, 

which is required under the HH QRP, 

and claims-based measures, which are 

calculated by CMS based on claims data 

HHAs already submit for purposes of 

payment. In many cases, measures from 

the expanded HHVBP Model overlap 

with those in the HH QRP, and HHAs 

would only need to submit data once to 

fulfill requirements of both. However, as 

described in section III.6.a. of this 

proposed rule, in the future we may 

propose new measures that may not 

otherwise already be collected or 

submitted by HHAs. 

We request comment on our proposal. 

(1) Form, Manner, and Timing of OASIS 

Measure Data 

CMS home health regulations, 

codified at § 484.250(a), require HHAs 

to submit to CMS OASIS data as is 

necessary for CMS to administer 

payment rate methodologies. All HHAs 

must electronically report all Outcome 

and Assessment Information Set 

(OASIS) 23 data collected in accordance 

with § 484.55(b), (c) and (d) in order to 

meet the Medicare CoPs, and as a 

condition for payment at § 484.205(c). 

The OASIS assessment contains data 

items developed to measure patient 

outcomes and improve home health 

care. HHAs submit the OASIS 

assessment in the internet Quality 

Improvement Evaluation System (iQIES) 

(https://iqies.cms.gov/). We note that the 

CoPs require OASIS accuracy and that 

monitoring and reviewing is done by 

CMS surveyors (§ 488.68(c)). It is 

important to note that to calculate 

quality measures from OASIS data, 

there must be a complete quality 

episode, which requires both a Start of 

Care (initial assessment) or Resumption 

of Care OASIS assessment and a 

Transfer or Discharge OASIS 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35930 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

24See 1115A(b)(4) of the Act (42 U.S.C. 1315a). 

assessment. Failure to submit sufficient 

OASIS assessments to allow calculation 

of quality measures, including transfer 

and discharge assessments, is a failure 

to comply with the CoPs § 484.225(i). 

HHAs do not need to submit OASIS 

data for patients who are excluded from 

the OASIS submission requirements 

Reporting Outcome and Assessment 

Information Set Data as Part of the 

Conditions of Participation for Home 

Health Agencies final rule (70 FR 76202) 

where we excluded patients— 

• Receiving only non-skilled services; 

• For whom neither Medicare nor 

Medicaid is paying for HH care (patients 

receiving care under a Medicare or 

Medicaid Managed Care Plan are not 

excluded from the OASIS reporting 

requirement); 

• Receiving pre- or post-partum 

services; or 

• Under the age of 18 years. 

We are proposing that HHAs 

participating in the expanded HHVBP 

Model would also be required to submit 

OASIS data according to the 

requirements of the CMS home health 

regulations codified at § 484.250(a) and 

OASIS data described in § 484.55(b), (c) 

and (d). If finalized, this would mean 

that HHAs would not be required to 

submit additional data through OASIS 

specifically for the expanded Model 

compared to what is already required 

for COPs, and there would be no 

additional burden. We note that this 

proposed requirement also aligns with 

requirements under the Home Health 

QRP (82 FR 4578). 

For the expanded Model, we propose 

that the underlying source data used to 

calculate an OASIS quality measure 

score beginning with the CY 2022 

performance year comes from 12 

months of OASIS assessment data from 

the applicable performance period via 

iQIES. The data extracted from iQIES for 

all OASIS measures, besides the two 

TNC measures, are aggregated to the 

monthly level for each HHA, separated 

by observed and predicted values used 

to calculate risk adjusted values. For the 

two TNC measures, we propose to use 

raw OASIS assessments to calculate 

applicable measure scores consistent 

with how we developed these measures. 

We request comment on our 

proposals. 

(2) Form, Manner, and Timing of 

HHCAHPS Survey Measure Data 

Under the HH QRP, HHAs are 

required to contract with an approved, 

independent HHCAHPS survey vendor 

to administer the HHCAHPS on its 

behalf (42 CFR 484.245(b)(1)(iii)(B)) 

among other requirements. 

For purposes of the expanded HHVBP 

Model, we propose similar requirements 

that align with the HH QRP HHCAHPS 

survey measure data reporting 

requirement at 484.245(b)(1)(iii). 

Specifically, under the expanded Model 

we propose that— 

• HHAs must contract with an 

approved, independent HHCAHPS 

survey vendor to administer the 

HHCAHPS survey on its behalf; 

• CMS approves an HHCAHPS survey 

vendor if the applicant has been in 

business for a minimum of 3 years and 

has conducted surveys of individuals 

and samples for at least 2 years; 

• A ‘‘survey of individuals’’ is 

defined as the collection of data from at 

least 600 individuals selected by 

statistical sampling methods and the 

data collected are used for statistical 

purposes; 

• No organization, firm, or business 

that owns, operates, or provides staffing 

for an HHA is permitted to administer 

its own HHCAHPS Survey or administer 

the survey on behalf of any other HHA 

in the capacity as an HHCAHPS survey 

vendor. Such organizations are not be 

approved by CMS as HHCAHPS survey 

vendors; 

• Approved HHCAHPS survey 

vendors must fully comply with all 

HHCAHPS survey oversight activities, 

including allowing CMS and its 

HHCAHPS survey team to perform site 

visits at the vendors’ company 

locations; and 

• Patient count exemption: HHAs that 

have fewer than 60 eligible unique 

HHCAHPS survey patients must 

annually submit to CMS their total 

HHCAHPS survey patient count to CMS 

to be exempt from the HHCAHPS survey 

reporting requirements for a calendar 

year. 

A CMS contractor provides the agency 

with the HHCAHPS survey measure 

score aggregated to the 12-months of 

data for the applicable performance 

period. 

The list of approved HHCAHPS 

survey vendors is available at https://

homehealthcahps.org or contact the 

HHCAHPS help desk hhcahps@rti.org. 

Again, we reiterate that these proposed 

requirements would align with those 

under the HH QRP and would not add 

additional burden to HHAs. 

We also propose to codify these 

proposals at § 484.355(a)(1)(ii). 

We request public comment on these 

proposals. 

(3) Form, Manner, and Timing of 

Claims-Based Measures 

Claims-based measures are derived 

from claims data submitted to CMS for 

payment purposes. Claims-based 

utilization measures provide 

information related to the use of health 

care services (for example, hospitals, 

emergency departments, etc.) resulting 

from a change in patient health status. 

We calculate claims-based measures 

based on claims data submitted to CMS 

for payment purposes. Therefore, HHAs 

do not need to submit additional 

information for purposes of calculating 

claims-based measures. 

We propose that the underlying 

source data for claims-based measures is 

12 months of claims data during the 

applicable performance period for 

purposes of payment under the 

expanded Model. 

We request comment on our proposal. 

(4) Proposed Data Reporting for 

Monitoring and Evaluation of the 

Expanded HHVBP Model 

Consistent with requirements under 

the original HHVBP Model 

at§ 484.315(c), we propose that 

competing HHAs under the expanded 

HHVBP Model would be required to 

collect and report information to CMS 

necessary for the purposes of 

monitoring and evaluating this model as 

required by statute.24 We also propose 

to codify this at § 484.355(b). 

We seek public comment on these 

proposals. 

(5) Proposal To Use Authority Under 

Section 1115A(d)(1) of the Act To Waive 

Provisions Outlined in 1890A(a)(1) and 

(3) Through (6) of the Act 

In section III.A.11. of this proposed 

rule, we propose a public reporting 

framework for the expanded HHVBP 

Model that would include annual public 

reporting of quality performance data. 

This data includes national benchmarks 

and achievement thresholds, HHA-level 

performance results for HHAs that 

qualify for an annual payment 

adjustment that includes applicable 

quality measure scores, Total 

Performance Scores and percentile 

rankings, improvement thresholds, and 

payment adjustment percentages. 

Section 1890A(a)(1) through (6) of the 

Act set forth requirements regarding the 

pre-rulemaking process for the selection 

of quality and efficiency measures 

described in section 1890(b)(7)(B) of the 

Act, including quality and efficiency 

measures used in reporting performance 

information to the public. We are 

proposing to utilize the Center for 

Medicare and Medicaid Innovation’s 

waiver authority under section 

1115A(d)(1) of the Act to waive the 

steps outlined in section 1890A(a)(1) 

and (3) through (6) of the Act that 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35931 

pertain to the pre-rulemaking process 

for publicly reporting performance 

information to the extent necessary to 

test the proposed expanded Model. 

Section 1115A(d)(1) of the Act allows 

the Secretary to waive certain statutory 

requirements ‘‘as may be necessary 

solely for purposes of carrying out this 

section with respect to testing models 

described in subsection (b).’’ 

Specifically, we propose to waive 

section1890A(a)(1) and (3) through (6) 

of the Act which pertains to: Convening 

multi-stakeholder groups to provide 

input to the Secretary on the use of 

quality and efficiency measures; 

transmitting the input from the multistakeholder groups to the Secretary; 

consideration of the input by the 

Secretary from the multi-stakeholder 

groups; publication in the Federal 

Register of the rationale on the quality 

and efficiency measures not endorsed 

for use; and, conduct an impact 

assessment every three years on the use 

of such measures. 

We note that we are not proposing to 

waive step 2 of the 6 steps in the prerulemaking process. Step 2 pertains to 

the public availability of measures 

considered for selection. Section 

1890A(a)(2) of the Act specifically 

applies to quality and efficiency 

measures under Title XVIII, whereas the 

expanded model would be implemented 

under section 1115A of the Act, which 

is in Title XI. 

We are proposing to waive the steps 

outlined in sections 1890A(a)(1) and (3) 

through (6) of the Act to the extent 

necessary in order to allow maximum 

flexibility to continue to test the 

expanded HHVBP Model under 

authority of section 1115A of the Act. 

The timeline associated with 

completing the steps described by these 

provisions would impede our ability to 

support testing new measures in a 

timely fashion, as well as testing new 

ways to incentivize quality performance 

in the home health setting and a new 

way to pay for home health care 

services. We plan to continue to seek 

input from a Technical Expert Panel 

(TEP) and to monitor quality measure 

performance to inform potential 

measure set changes under the 

expanded Model. Waiving the five steps 

noted previously for the expanded 

HHVBP Model would allow for a more 

flexible timeline with more timely 

evaluation and monitoring of quality 

performance and results. 

Flexibility in timing to adjust the 

quality measure set and/or methodology 

to respond to unexpected events and 

trends in home health care, as well as 

to respond timely to any stakeholder 

concerns, is critical to the success of the 

HHVBP Model expansion. The ongoing 

uncertainty levied by the COVID–19 

pandemic, and similar events that may 

come in the future, requires us to 

maintain responsiveness to anomalies in 

the quality measure data. These 

challenges may require the flexibility to 

timely implement changes to ensure 

that measure sets continue to 

appropriately assess performance in 

light of external factors. In addition, 

trends in market consolidation and 

small business policies in the home 

health care industry could require 

certain adjustments to measure 

methodology, that is, minimum volume 

requirements, or require adjustment to 

the applicability of measures. The home 

health care sector is also becoming a 

more important source of care for 

beneficiaries who prefer to age in the 

community, rather than in an 

institution. This trend, in addition to 

the national shift in beneficiary 

demographics, could require flexibility 

in the quality measure set. This 

flexibility would be a key lever to adapt 

the Model to the unpredictable changes 

led by beneficiary preference, industry 

trends, and unforeseen nationwide 

events that HHAs are particularly 

sensitive to. We seek comment on our 

proposal to waive the steps outlined in 

section 1890A(a)(1) and (3) through (6) 

of the Act as applicable and to the 

extent necessary to test the proposed 

expanded Model. 

7. Proposed Performance Scoring 

Methodology 

a. Considerations for Developing the 

Proposed Total Performance Score 

Methodology 

We considered several factors when 

we initially developed and subsequently 

refined the performance scoring 

methodology over the course of the 

original Model, and we are proposing to 

apply a similar methodology for the 

expanded HHVBP Model. We explain 

later in this section how we propose to 

calculate a ‘‘performance score’’ for each 

applicable measure for each competing 

HHA, which is defined as the 

achievement or improvement score 

(whichever is greater). The ‘‘Total 

Performance Score,’’ or ‘‘TPS,’’ is the 

numeric score, ranging from 0 to 100, 

awarded to each qualifying HHA based 

on the weighted sum of the performance 

scores for each applicable quality 

measure under the HHVBP Model 

expansion. The following principles 

guided the original Model’s design, as 

well as these proposals for the expanded 

Model. 

First, we believe the performance 

scoring methodology should be 

straightforward and transparent to 

HHAs, beneficiaries, and other 

stakeholders. HHAs should be able to 

clearly understand performance scoring 

methods and performance expectations 

to optimize quality improvement efforts. 

The public should also understand 

performance score methods to utilize 

publicly-reported information when 

choosing HHAs. 

Second, we believe the performance 

scoring methodology for the proposed 

HHVBP Model expansion should be 

aligned appropriately with the quality 

measurements adopted for other 

Medicare value-based purchasing 

programs, including those introduced in 

the hospital and skilled nursing home 

settings. This alignment would facilitate 

the public’s understanding of quality 

measurement information disseminated 

in these programs and foster more 

informed consumer decision-making 

about their health care choices. 

Third, we believe that differences in 

performance scores must reflect true 

differences in performance. To make 

sure that this point is addressed in the 

performance scoring methodology for 

the proposed HHVBP Model expansion, 

we assessed quantitative characteristics 

of the measures, including the current 

state of measure development, number 

of measures, and the number and 

grouping of measure categories. 

Fourth, we believe that both quality 

achievement and improvement must be 

measured appropriately in the 

performance scoring methodology for 

the expanded HHVBP Model. The 

proposed methodology specifies that 

performance scores under the expanded 

HHVBP Model would be calculated 

utilizing the higher of achievement or 

improvement scores for each measure, 

with achievement out of 10 points and 

improvement out of 9. We considered 

the impact of performance scores 

utilizing achievement and improvement 

on HHAs’ behavior and the resulting 

payment implications. As under the 

original Model, using the higher of 

achievement or improvement scores 

would allow the Model expansion to 

recognize HHAs that have made 

improvements, though their measured 

performance score may still be relatively 

lower in comparison to other HHAs. By 

limiting the improvement score to a 

scale across 0 to 9, we prioritize 

achievement relative to improvement. 

Fifth, we intend that the expanded 

Model would utilize the most currently 

available data to assess HHA 

performance, to the extent appropriate 

and feasible within the current 

technology landscape. We recognize 

that not all HHAs have the ability to 

submit data electronically or digitally 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35932 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

and that the proposed quality measure 

data would not be available 

instantaneously due to the time required 

to collect, submit, and process quality 

measurement information accurately; 

however, we intend to process data as 

efficiently as possible. 

b. Proposed Performance Score 

Methodology 

(1) Overview 

The goal of the performance scoring 

methodology would be to produce a 

TPS for each qualifying HHA based on 

its raw scores on each applicable quality 

measure included in the expanded 

HHVBP Model. We would then use the 

HHA’s TPS to determine the HHA’s 

payment adjustment percentage. At a 

high level, the following summarizes 

the proposed steps for determining an 

HHA’s TPS under the expanded Model, 

which is similar to the approach used 

under the original Model: (1) Each HHA 

would receive a raw quality measure 

score for each applicable measure 

during the performance year; (2) the 

HHA would receive an ‘‘achievement 

score’’ for each applicable measure, 

which is defined as a numeric value 

between 0 and 10 that quantifies an 

HHA’s performance on a given quality 

measure compared to other HHAs in the 

same cohort in the baseline year 

(calculated using the achievement 

threshold and benchmark, as defined in 

section III.A.7.b.2. of this proposed 

rule); (3) each HHA would also receive 

an ‘‘improvement score’’ for each 

applicable measure, which is defined as 

a numeric value between 0 and 9, that 

quantifies an HHA’s performance on a 

given quality measure compared to its 

own individual performance in the 

baseline year (the improvement 

threshold, as defined in section 

III.A.7.b.2. of this proposed rule); (4) 

each HHA would be assigned a 

‘‘performance score’’ on each applicable 

measure that is the higher of the 

achievement score or the improvement 

score, as described in section III.A.7.b.2 

of this proposed rule; and (5) each 

performance score would then be 

weighted, using each measure’s 

assigned weight, and summed to 

generate the HHA’s TPS, as described in 

section III.A.7.e. of this proposed rule. 

The result of this process would be a 

TPS for each competing HHA that can 

be translated into a payment adjustment 

percentage using the LEF applicable to 

each cohort, as described in section 

III.A.8. of this proposed rule. 

Our proposal for the performance 

scoring methodology under the 

expanded HHVBP Model follows 

closely to that of the original Model. As 

discussed in more depth in the sections 

that follow, under the expanded HHVBP 

Model, we propose that we would 

assess each HHA’s TPS based upon all 

applicable quality measures (defined 

below) in the expanded Model measure 

set in the applicable performance year. 

Each competing HHA would receive an 

interim assessment on a quarterly basis, 

as described in detail in section 

III.A.9.a. of this proposed rule. The 

performance scoring methodology 

would be used to determine an annual 

distribution of value-based payment 

adjustments among HHAs in a cohort so 

that HHAs achieving the highest 

performance scores would receive the 

largest upward payment adjustment. 

The proposed methodology includes 

three primary features, each of which is 

discussed in more detail in the sections 

that follow: 

• The HHA’s TPS would reflect all of 

the claims- and OASIS-based measures 

for which the HHA meets the minimum 

of 20 home health episodes of care per 

year and all of the individual 

components that compose an HHCAHPS 

survey measure for which the HHA 

meets the minimum of 40 HHCAHPS 

surveys received in the performance 

year, defined as ‘‘applicable measures’’. 

• An HHA’s TPS would be 

determined by weighting and summing 

the higher of that HHA’s achievement or 

improvement score for each applicable 

measure as described in section 

III.A.7.b. of this proposed rule. 

• The claims-based, OASIS 

assessment-based, and the HHCAHPS 

survey-based measure categories would 

be weighted 35 percent, 35 percent, and 

30 percent, respectively, and would 

account for 100 percent of the TPS. If an 

HHA is missing a measure category or 

a measure within the OASIS-based 

measure category, the measures would 

be reweighted, as described further in 

section III.A.7.e. of this proposed rule. 

As noted, we are proposing that many 

of the key elements from the original 

Model’s performance scoring 

methodology would also apply for the 

expanded HHVBP Model, as we discuss 

in more detail in the sections that 

follow. The primary changes between 

the original Model and the expanded 

Model would be that first, because we 

are not proposing to require submission 

of the New Measures data, we would 

not consider New Measures in 

calculating the TPS under the expanded 

Model. The New Measures reporting 

currently accounts for 10 percent of the 

TPS under the original HHVBP Model. 

In addition, we are proposing small 

changes to the achievement and 

improvement score formulas to simplify 

their calculation and interpretation, 

without materially changing the output. 

We are also proposing to calculate 

benchmarks and achievement 

thresholds based on national volumebased cohorts, as opposed to the Statebased cohorts under the original Model, 

to align with the proposal for volumebased cohorts as described in section 

III.A.4. of this proposed rule. Finally, 

we are proposing to change the potential 

score range for the TNC Mobility and 

TNC Self-Care measures from 0 to 15 

points for achievement and 0 to 13.5 

points for improvement as under the 

original Model, to 0 to 10 points for 

achievement and 0 to 9 points for 

improvement in the expanded Model. 

This change simplifies and aligns the 

calculation of the composite measure 

scores. The proposed weighting in the 

expanded Model, which follows the 

original Model, accounts for the 

intended increase in relative 

contribution from these composite 

measures to the TPS. 

(2) Proposed Calculation of the 

Benchmark and Achievement Threshold 

For scoring HHAs’ performance on 

measures in the claims-based, OASISbased, and the HHCAHPS survey-based 

categories, we propose similar elements 

of the scoring methodology as set forth 

in the original Model (as described in 

§ 484.320), including allocating points 

based on achievement or improvement 

and calculating those points based on 

benchmarks and thresholds. As 

proposed in section III.A.5.b.1. of this 

proposed rule, with the exception of 

new HHAs, the baseline year would be 

CY 2019 (January 1, 2019 through 

December 31, 2019) for the CY 2022 

performance period/CY 2024 payment 

year and subsequent years. All 

benchmarks and achievement 

thresholds would be set based on HHA 

performance in the designated baseline 

year. 

We propose that to determine 

achievement points for each measure, 

HHAs would receive points along an 

achievement range, which is a scale 

between the achievement threshold and 

a benchmark. We propose to define the 

‘‘achievement threshold’’ as the median 

(50th percentile) of all HHAs’ 

performance scores on the specified 

quality measure during the baseline 

year, calculated separately for the largerand smaller-volume cohorts. We 

propose to calculate the benchmark as 

the mean of the top decile of all HHAs’ 

performance scores on the specified 

quality measure during the baseline 

year, calculated separately for the largerand smaller-volume cohorts. Unlike the 

original Model, for the expanded 

HHVBP Model, we are proposing to use 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35933 

a national sample separated into largervolume and smaller-volume HHA 

cohorts to calculate both the 

achievement threshold and the 

benchmark, rather than calculating 

individual values for each selected State 

as in the original Model, as described in 

section III.A.4.b. of this proposed rule. 

We also propose that to determine 

improvement points for each measure, 

HHAs would receive points along an 

improvement range, which is a scale 

between an HHA’s performance during 

the baseline year and the benchmark. 

The HHA’s baseline year score is termed 

the ‘‘improvement threshold.’’ The 

benchmark is the same benchmark used 

in the achievement calculation. The 

achievement threshold and benchmarks 

for each cohort, and the improvement 

threshold for each HHA, calculated 

using baseline year performance scores, 

would be provided to the HHAs as soon 

as feasible. In addition, benchmarks, 

achievement thresholds, and 

improvement thresholds for each 

measure would be restated on each 

HHA’s interim performance report (IPR). 

We also propose to codify the proposed 

definitions of achievement threshold, 

benchmark, and improvement threshold 

at § 484.345. We seek public comment 

on these proposals. 

(i) Proposed Calculation of Achievement 

Score 

In the original Model, we calculated 

the achievement score by dividing the 

difference between the HHA’s 

performance score and the achievement 

threshold by the difference between the 

benchmark and the achievement 

threshold, multiplying the quotient by 

9, and then taking the product and 

adding 0.5 (80 FR 68681). 

Under the expanded HHVBP Model, 

we propose a similar approach, but with 

minor modifications intended to 

improve and simplify the calculation 

and the interpretation of the 

achievement score. Under the expanded 

Model, as under the original Model, we 

propose that an HHA could earn 

between 0 to 10 achievement points for 

each applicable measure based on its 

performance during the performance 

year relative to other HHAs in its cohort 

in the baseline years, quantified by the 

achievement threshold and the 

benchmark, as proposed in section 

III.A.7.b.2. of this proposed rule. We 

propose to calculate the achievement 

score using the following formula: 

Relative to the original Model, this 

proposed equation is simplified, for ease 

of calculation and interpretation, by 

multiplying it by 10, as opposed to 9, 

and by no longer adding 0.5. The 

performance rankings would not be 

materially affected by this change. 

Should the calculated achievement 

points exceed 10 in the equation, we 

propose that the maximum achievement 

points would be capped at 10 

achievement points. As under the 

original Model, we propose to round 

each measure’s achievement points up 

or down to the third decimal point 

under the expanded HHVBP Model. For 

example, an achievement score of 

4.5555 would be rounded to 4.556. This 

ensures precision in scoring and ranking 

HHAs within each cohort. In 

determining an achievement score based 

on the HHA’s raw quality measure 

score, we propose to apply the following 

rules to the achievement score 

calculation to ensure the achievement 

score falls within the range of 0 to 10 

points to align with the simplified 

equation: 

• An HHA with a raw quality 

measure score greater than or equal to 

the benchmark receives the maximum of 

10 points for achievement. 

• An HHA with a raw quality 

measure score greater than the 

achievement threshold (but below the 

benchmark) receives greater than 0 but 

less than 10 points for achievement 

(prior to rounding), by applying the 

achievement score formula. 

• An HHA with a raw quality 

measure score that is less than or equal 

to the achievement threshold receives 0 

points for achievement. 

We are proposing to no longer 

calculate the achievement scoring for 

the TNC Self-Care and TNC Mobility 

measures out of 15 possible points, as 

under the original Model, and to instead 

simplify and align the calculation with 

other measures by calculating 

achievement scoring for the composite 

measures out of 10 possible points. The 

proposed weighting, consistent with the 

original Model, would already assign a 

larger contribution from these 

composite measures to the overall 

OASIS category score, as described in 

section III.A.7.e.(2).(iii). of this proposed 

rule. We also propose to codify these 

proposals at § 484.360. We seek public 

comment on these proposals. 

(ii) Proposed Calculation of the 

Improvement Score 

In the original Model, beginning with 

performance year 4, we calculated 

improvement scores by dividing the 

difference between the HHA’s 

performance year score and the HHA’s 

baseline year score by the difference 

between the benchmark and the HHA’s 

baseline year score, multiplying the 

quotient by 9, and then taking the 

product and subtracting 0.5 to calculate 

the improvement score (83 FR 56543). 

Similarly, under the expanded 

HHVBP Model, we propose to allocate 

0 to 9 improvement points to an HHA 

for each applicable measure based upon 

how much an HHA’s performance score 

in the performance year improved 

relative to its performance score during 

the baseline year. The expanded HHVBP 

Model aims to ensure that all HHAs 

provide high quality care and awarding 

more points for achievement than for 

improvement supports this goal. This 

continues to also align with the HVBP 

Program, where hospitals can earn a 

maximum of 9 improvement points if 

their measure score falls between the 

improvement threshold and the 

benchmark (76 FR 26515). 

We propose to establish a unique 

improvement range for each measure 

and for each HHA that defines the 

difference between the HHA’s baseline 

year score (referred to as the 

‘‘improvement threshold’’) and the 

benchmark for the applicable measure, 

calculated for the applicable volumebased HHA cohort, which is the same 

benchmark used in the achievement 

scoring calculation. The following 

proposed improvement score formula 

quantifies the HHA’s performance on 

each applicable measure in the 

performance year relative to its own 

performance in the baseline year by 

calculating the improvement score: 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.042</GPH> EP07JY21.043</GPH>

A h. S lO ( HHA Performance Score-Achievement Threshold) c 1evement core = x 

Benchmark-Achievement Threshold 

I t S 9 ( HHA Performance Score-HHA Improvement Threshold) mprovemen core = x 

Benchmark-HHA Improvement Threshold 
35934 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

25The proposed formula for calculating 

achievement points is 10 * (HHA Performance Year 

Score¥Achievement Threshold)/ 

(Benchmark¥Achievement Threshold). 

26The proposed formula for calculating 

improvement points is 9 * (HHA Performance Year 

Score¥HHA Improvement Threshold)/(HHA 

Benchmark¥HHA Improvement Threshold). 

Relative to the original Model, this 

proposed equation is simplified, for ease 

of calculation and interpretation, by no 

longer subtracting 0.5. Should the 

calculated points exceed 9, we propose 

that the maximum improvement points 

would be capped at 9 improvement 

points. Like the achievement points, we 

propose to round each measure’s 

improvement points up or down to the 

third decimal point under the expanded 

HHVBP Model. 

In calculating the improvement score 

based on the HHA’s raw quality 

measure score, we are proposing to 

apply the following rules to the 

improvement score calculation to 

ensure the improvement score falls 

within the range of 0 to 9 points to align 

with the simplified equation: 

• If the HHA’s raw quality measure 

score is greater than or equal to the 

benchmark, the HHA would receive an 

improvement score of 9 points—an 

HHA with a raw quality measure score 

greater than or equal to the benchmark 

could still receive the maximum of 10 

points for achievement. 

• If the HHA’s raw quality measure 

score is greater than its improvement 

threshold but below the benchmark 

(within the improvement range), the 

HHA would receive an improvement 

score that is greater than 0 and less than 

9 (before rounding) based on the 

improvement score formula and as 

illustrated in the examples in the next 

section. 

• If the HHA’s raw quality measure 

score is less than or equal to or its 

improvement threshold for the measure, 

the HHA would receive 0 points for 

improvement. 

We are proposing to no longer 

calculate the improvement scoring for 

the TNC Self-Care and TNC Mobility 

measures out of 13.5 possible points, as 

under the original Model, and to instead 

simplify and align the calculation with 

other measures by calculating 

improvement scoring for the composite 

measures out of 10 possible points. The 

proposed weighting, consistent with the 

original Model, would already assign a 

larger contribution from these 

composite measures to the overall 

OASIS category, as described in section 

III.A.7.e.(2).(iii). of this proposed rule. 

We also propose to codify these 

proposals at § 484.360. We seek public 

comment on these proposals. 

(iii) Examples of Calculating 

Achievement and Improvement Scores 

For illustrative purposes, the 

following examples demonstrate how 

the performance scoring methodology 

would be applied in the context of the 

measures in the claims-based, OASISbased, and the HHCAHPS survey-based 

categories. These HHA examples are 

based on illustrative data from CY 2019 

(for the baseline year) and hypothetical 

data for CY 2022 (for the performance 

year). The benchmark calculated for the 

Dyspnea measure is 97.676 for HHA A 

(calculated as the mean of the top decile 

of HHA performance from the CY 2019 

baseline year for the volume-based 

cohort). The achievement threshold is 

75.358 (calculated as the median or the 

50th percentile of HHA performance 

from the CY 2019 baseline year for the 

same volume-based cohort). 

Figure 4 shows the scoring for HHA 

‘A’ as an example. HHA A’s CY 2022 

performance year score for the Dyspnea 

measure was 98.348, exceeding both the 

CY 2019 achievement threshold and 

benchmark, which means that HHA A 

earned the maximum 10 points based on 

its achievement score. Its improvement 

score is irrelevant in the calculation 

because the HHA’s performance score 

for this measure exceeded the 

benchmark, and the maximum number 

of improvement points possible is 9. 

Figure 4 also shows the scoring for 

HHA ‘B.’ HHA B’s performance on the 

Dyspnea measure was 52.168 for the CY 

2019 baseline year (HHA B’s 

improvement threshold) and increased 

to 76.765 (which is above the 

achievement threshold of 75.358) for the 

CY 2022 performance year. To calculate 

the achievement score, HHA B would 

earn 0.630 achievement points, 

calculated as follows: 10 * 

(76.765¥75.358)/(97.676¥75.358) = 

0.630.25 Calculating HHA B’s 

improvement score yields the following 

result: Based on HHA B’s period-toperiod improvement, from 52.168 in the 

baseline year to 76.765 in the 

performance year, HHA B would earn 

4.864 improvement points, calculated as 

follows: 9 * (76.765¥52.168)/ 

(97.676¥52.168) = 4.864.26 Because the 

higher of the achievement and 

improvement scores is used, HHA B 

would receive 4.864 improvement 

points for this measure. 

In Figure 5, HHA ‘C’ yielded a decline 

in performance on the TNC Self-Care 

measure, falling from 70.266 to 58.487. 

HHA C’s performance during the 

performance year was lower than the 

achievement threshold of 75.358 and, as 

a result, HHA C would receive zero 

points based on achievement. It would 

also receive zero points for 

improvement because its performance 

during the performance year was lower 

than its improvement threshold. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35935 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.044</GPH>

FIGURE 4: EXAMPLE OF AN HHA EARNING POINTS BY ACHIEVEMENT OR 

IMPROVEMENT SCORING 

Achievement 

HHAA 

HHA B Improvement 

Measure: Dyspnea 

Achievement Threshold Benchmark 

75.358 •<-------)-. 97.676 

Achievement Range 

HHA A Score: 10 maximum points for achievement 

Improvement 

Threshold 

Performance 

Year Score 

52.168 4(-----------)• 76.765 

HHA B Score: The greater of 0.630 points for 

achievement and 4.864 points for improvement. 

98.348 
35936 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

27Centers for Medicare & Medicaid Services. 

(2020, April). Quality of Patient Care Star Ratings 

Methodology. Home Health Quality of Patient Care 

Star Ratings. https://www.cms.gov/files/document/ 

quality-patient-care-star-ratings-methodologyapril2020.pdf. 

28Centers for Medicare & Medicaid Services. 

(2016, March). Technical Notes for HHCAHPS Star 

Ratings. Home Health HHCAHPS Star Ratings. 

https://homehealthcahps.org/Portals/0/HHCAHPS_

Stars_Tech_Notes.pdf. 

BILLING CODE 4120–01–C 

c. Minimum Threshold Number of Cases 

for Claims-Based, OASIS-Based, and 

HHCAHPS Survey-Based Measures To 

Receive a Measure Score 

For the expanded Model, we are 

proposing to apply the same policies 

around minimum case counts for each 

measure as implemented under the 

original Model, as described in 

proposed § 484.345. We propose to 

continue to award an HHA the higherof achievement or improvement points, 

as proposed previously, for ‘‘applicable 

measures’’ only. Under this proposal, 

for the measures included in the claimsbased and OASIS-based measure 

categories, an ‘‘applicable measure’’ is 

one for which the HHA has provided a 

minimum of 20 home health episodes of 

care per year and, therefore, has at least 

20 cases in the denominator. We are 

proposing this minimum to align with 

the original HHVBP Model and the 

measure specifications used for the 

Patient Quality of Care Star Ratings.27

For the individual components that 

compose the HHCAHPS survey 

measure, an ‘‘applicable measure’’ 

means a component for which a 

competing HHA has submitted a 

minimum of 40 completed HHCAHPS 

surveys. A minimum of 40 completed 

HHCAHPS surveys for each applicable 

measure for the expanded Model 

represents a balance between providing 

meaningful data for payment 

adjustments and having more HHAs 

with sufficient numbers of measures 

with performance scores. Moreover, 

using a minimum of 40 completed 

HHCAHPS surveys for each applicable 

measure would align with the Patient 

Survey Star Ratings on Home Health 

Compare.28

We also propose to codify this 

proposed definition of an ‘‘applicable 

measure’’ at § 484.345. We seek public 

comment on these proposals. 

d. Minimum Number of Applicable 

Measures for an HHA To Receive a Total 

Performance Score 

For the expanded Model, we are 

proposing to apply the same policies 

around the minimum number of 

applicable measures to receive a TPS, as 

implemented under the original Model. 

We are proposing that, beginning with 

the CY 2022 performance year and for 

subsequent years, an HHA that does not 

meet the minimum threshold of cases or 

completed HHCAHPS surveys, as 

applicable, on five or more measures 

under the expanded Model would not 

receive a TPS or a payment adjustment 

based on that performance year. Under 

the expanded Model, this means 5 of the 

12 possible applicable measures in the 

measure set, which includes two claimsbased measures, 5 OASIS-based 

measures, and the 5 components from 

the HHCAHPS survey measure. HHAs 

without five applicable measures for a 

performance year would be paid for 

HHA services in an amount equivalent 

to the amount that would have been 

paid under section 1895 of the Act. We 

believe that a minimum of five 

applicable measures allows for a robust 

basis on which to adjust payment while 

also maximizing the number of HHAs 

eligible for the payment adjustment. 

Although those HHAs that do not 

meet this minimum would not be 

subject to payment adjustments under 

the expanded Model, we propose that 

other applicable policies under the 

expanded HHVBP Model would still 

apply. We propose that these HHAs 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.045</GPH>

FIGURE 5: EXAMPLE OF AN HHA NOT EARNING POINTS BY ACHIEVEMENT 

OR IMPROVEMENT SCORING 

Achievement 

HHAC 

Measure: TNC Self-Care Measure 

Achievement Threshold Benchmark 

75.358 •(-------) ....97.676 

Achievement Range 

Performance Improvement 

Year Score Threshold 

+ + 

58.487 ( ) 70.266 

HHA C Score: 0 points for improvement 

and O points for achievement 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35937 

29OASIS-based measures reweighting = 35% 

original OASIS weight/(35% original OASIS weight 

+ 30% original HHCAHPS weight) = 53.85% 

revised OASIS weight. 

30HHCAHPS reweighting = 30% original 

HHCAHPS weight/(35% original OASIS weight + 

30% original HHCAHPS weight) = 46.15% revised 

HHCAHPS weight. 

31TNC Mobility reweighting = 25% original TNC 

Mobility weight/(25% original TNC Mobility weight 

+ 16.67% original Discharged to Community weight 

+ 16.67% original Oral Medications weight) = 

42.85% revised TNC Mobility weight. 

32 Discharged to Community reweighting = 

16.67% original Discharged to Community weight/ 

(25% original TNC Mobility weight + 16.67% 

original Discharged to Community weight + 16.67% 

original Oral Medications weight) = 28.57% revised 

Discharged to Community weight. 

33Oral Medications reweighting = 16.67% 

original Oral Medications weight/(25% original 

TNC Mobility weight + 16.67% original Discharged 

to Community weight + 16.67% original Oral 

Medications weight) = 28.57% revised Oral 

Medications weight. 

would receive IPRs for any measures 

that meet the definition of applicable 

measure, and they would continue to 

have future opportunities to compete for 

payment adjustments. Based on the 

most recent data available, the vast 

majority of HHAs are reporting on at 

least five applicable measures. In 2019, 

those with less than five applicable 

measures account for less than 2.4 

percent of the claims made (and 2.0 

percent of claims payments made) 

across the 9,526 HHAs delivering care 

nationwide. 

We also propose to codify this 

proposal at § 484.360(c). We seek public 

comment on this proposal. 

e. Proposed Weights for the ClaimsBased, OASIS-Based, and HHCAHPS 

Survey Measures 

Except for removing the New 

Measures category, for the expanded 

HHVBP Model, we are generally 

proposing the same policies regarding 

the weighting of measures and the redistribution of weights when measures 

or measure categories are missing as 

under the original Model (83 FR 56536). 

(1) Proposed Weighting and ReDistribution of Weights Between the 

Measure Categories 

In this proposed rule, we propose to 

group the expanded Model proposed 

measures into measure categories based 

on their data source as indicated in 

Table 28: Claims-based, OASIS-based, 

and the HHCAHPS survey-based. We 

propose that claims-based, OASISbased, and the HHCAHPS survey-based 

categories would be weighted 35 

percent, 35 percent, and 30 percent, 

respectively, when the HHA has 

applicable measures in all three 

categories and otherwise meets the 

minimum threshold to receive a TPS. 

Together, all three categories would 

account for 100 percent of the TPS. The 

measure weights reflect prioritization of 

the two claims-based measures because 

they may have a greater impact on 

reducing Medicare expenditures. In 

addition, we also place slightly more 

weight on the OASIS-based measures 

since they represent a larger variety of 

measures covering a range of quality 

topics as compared to the HHCAHPS 

survey measure. 

We also propose that where an HHA 

is missing all measures from a single 

measure category, the weights for the 

remaining two measure categories 

would be redistributed such that the 

proportional contribution remains 

consistent with the original weights. For 

instance, some smaller-volume HHAs 

may be missing the HHCAHPS survey 

measure, which would require redistributing weights to the claims-based 

(otherwise weighted 35 percent) and 

OASIS-based (otherwise weighted 35 

percent) measure categories, such that 

the claims-based and OASIS-based 

measure categories would each be 

weighted at 50 percent of the total TPS. 

Where an HHA is missing the claimsbased category, the OASIS-based 

(otherwise weighted 35 percent) and the 

HHCAHPS survey (otherwise weighted 

30 percent) measure categories would be 

reweighted to 53.85 percent for the 

OASIS-based measures and 46.15 

percent for the HHCAHPS survey 

measure.29 30 Finally, we propose that if 

two measure categories are missing, the 

remaining category would be weighted 

100 percent. We refer readers to Table 

29 for the distribution of measure 

category weights under various 

scenarios. 

(2) Proposed Quality Measure Weights 

Within Measure Categories 

Within the measure categories, we are 

proposing to weight certain individual 

measures differently than other 

measures in the same category. 

(i) HHCAHPS Survey Measure Category 

For the HHCAHPS survey measure 

category, we propose that all five 

components are weighted equally to 

determine the overall HHCAHPS survey 

measure percentage, which would 

contribute 30 percent to the overall TPS. 

This measure category would not 

require re-distribution of weights for the 

individual components because HHAs 

either meet the minimum requirement 

for number of completed surveys for all 

HHCAHPS survey measure components 

or they do not meet the minimum 

requirements. 

(ii) Claims-Based Measure Category 

For the claims-based measure 

category, we are proposing to weight the 

ACH measure at 75 percent, and the ED 

Use measure at 25 percent of the total 

measure weight for this measure 

category. We are proposing to place a 

higher weight on the ACH measure 

because it reflects a more severe health 

event and because inpatient 

hospitalizations generally result in more 

Medicare spending than the average 

emergency department visit that does 

not lead to an acute hospital admission. 

Like the HHCAHPS survey measure 

components, an HHA would either have 

sufficient volume for both claims-based 

measures to be applicable measures or 

it would have data for neither measure 

since both measures require the same 

minimum of 20 episodes per 

performance year. Consequently, redistributing weights for either measure 

within the claims-based measure 

category should not be necessary. 

(iii) OASIS-Based Measure Category 

For the OASIS-based measure 

category, we propose to weight both the 

TNC Self Care and TNC Mobility 

measures at 25 percent each; and the 

Dyspnea, Discharged to Community, 

and Oral Medications measures at 16.67 

percent each of the total measure weight 

for this measure category. Both the TNC 

Self-Care and TNC Mobility measures 

are composed of several measures that 

are consolidated into two composite 

measures; because of this, we are 

proposing to weight them slightly more 

than the other three measures, which 

are not composite measures, as under 

the original Model. Under this proposal, 

should any measures in the category be 

missing, we propose to re-distribute 

weights across the measures such that 

the original proportions are maintained. 

For instance, should an HHA be missing 

both the TNC Self-Care and Dyspnea 

measures, the remaining measures 

would be weighted as 42.85 percent for 

the TNC Mobility measure, 28.57 

percent for the Discharged to 

Community measure, and 28.57 percent 

for the Oral Medications measure, 

which reflects the relative ratios of 25 

percent to 16.67 percent to 16.67 

percent, respectively.31 32 33

See Table 28 for a comprehensive list 

of the proposed within-category 

measure weights. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35938 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

Table 29 presents the proposed 

weights for the proposed measures and 

measure categories under various 

reporting scenarios. 

We also propose to codify these 

proposals at § 484.360. We seek public 

comment on these proposals. 

f. Examples of the Total Performance 

Score Calculation 

The following are two examples of the 

proposed performance score calculation, 

beginning with the assigned 

achievement vs. improvement points. 

The following describes the TPS 

calculations for HHA ‘‘D’’ and HHA 

‘‘E.’’ 

In this first example, out of a possible 

12 applicable measures, which includes 

two claims-based measures, five OASIS 

assessment-based measures, and five 

components that make up the 

HHCAHPS survey measure, HHA ‘‘D’’ 

has at least 20 episodes of care and 

received at least 40 completed 

HHCAHPS surveys in the 12-month 

performance year, which means the 

HHA received scores on all 12 quality 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.046</GPH> EP07JY21.047</GPH>

TABLE 28: PROPOSED WITHIN-CATEGORY MEASURE WEIGHTS 

Within-category 

Measure Weight 

Cate~ory Quality Measures (percenta~e) 

TNC Self-Care 25.00 

TNC Mobility 25.00 

OASIS Dyspnea 16.67 

Discharged to Community 16.67 

Oral Medications 16.67 

Claims ACH 75.00 

ED Use 25.00 

HHCAHPS Professional Care 20.00 

HHCAHPS HHCAHPS Communication 20.00 

HHCAHPS Team Discussion 20.00 Survey HHCAHPS Overall Rating 20.00 

HHCAHPS Willingness to Recommend 20.00 

TABLE 29: PROPOSED QUALITY MEASURE WEIGHTING AND REWEIGHTING SCHEDULE 

Measure Reportin2 Scenarios 

All No No Claims or 

Measure Measures HHCAHPS No Claims HHCAHPS 

OASIS 

TNC Self-Care 8.75% 12.50% 13.46% 25.00% 

TNC Mobility 8.75% 12.50% 13.46% 25.00% 

Oral Medications 5.83% 8.33% 8.98% 16.67% 

Dvspnea 5.83% 8.33% 8.98% 16.67% 

Discharged to Communitv 5.83% 8.33% 8.98% 16.67% 

Total for OASIS-based measures 35.00% 50.00% 53.85% 100.00% 

Claims 

ACH 26.25% 37.50% 0.00% 0.00% 

ED Use 8.75% 12.50% 0.00% 0.00% 

Total for claims-based measures 35.00% 50.00% 0.00% 0.00% 

HHCAHPS Survev Measure Comoonents 

HHCAHPS Professional Care 6.00% 0.00% 9.23% 0.00% 

HHCAHPS Communication 6.00% 0.00% 9.23% 0.00% 

HHCAHPS Team Discussion 6.00% 0.00% 9.23% 0.00% 

HHCAHPS Overall Rating 6.00% 0.00% 9.23% 0.00% 

HHCAHPS Willingness to Recommend 6.00% 0.00% 9.23% 0.00% 

Total for the HHCAHPS Survey-based measure 30.00% 0.00% 46.15% 0.00% 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35939 

measures. Under the proposed scoring 

methodology outlined previously, for 

HHA D, the measure category weights 

would be as follows: 35 percent for the 

claims-based measures, 35 percent for 

the OASIS assessment-based measures, 

and 30 percent for the HHCAHPS 

Survey-based measures. See Table 30 for 

a detailed calculation of the TPS. For 

each measure in column 1, HHA D 

receives the highest of its achievement 

or improvement score, which is listed in 

column 2. Each applicable measure’s 

weight is listed in column 3. To 

determine the weighted points in 

column 4, multiply the measure score in 

column 2 by the measure’s weight in 

column 3 and then by 10. The total 

performance score is the sum of all the 

weighted points listed in column 4. In 

the case of HHA D, the TPS is 46.021. 

In the second example, HHA ‘‘E’’ has 

only seven applicable measures. 

Because it did not receive the minimum 

count of HHCAHPS surveys for all 

components, HHA E did not receive any 

scores on the HHCAHPS Survey 

components. Where an HHA is missing 

the HHCAHPS Survey components, the 

HHA’s HHCAHPS Survey measure 

category is re-weighted at 0% and the 

remaining two measure categories are 

re-weighted such that their proportional 

contribution remains consistent with 

the original weights and the total of the 

weights sums to 100 percent. Based on 

the ratio of the original weights for the 

claims-based (35 percent) and the 

OASIS-based (35 percent) measure 

categories, each category contributes 50 

percent to the TPS. See Table 30 for the 

detailed calculation of the TPS. For each 

applicable measure in column 1, HHA 

E received the highest of its 

achievement or improvement score, 

which is listed in column 2. Column 2 

lists N/A for each of the HHCAHPS 

Survey measure components since this 

HHA had fewer than 40 HHCAHPS 

surveys in the performance year. Each 

applicable measure’s weight is listed in 

column 3. To determine the weighted 

points in column 4, multiply the 

measure score in column 2 by the 

applicable measure’s weight in column 

3 and then by 10. The total performance 

score is the sum of all the weighted 

points listed in column 4. In the case of 

HHA E, the TPS is 27.750. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.048</GPH>

TABLE 30: HHA D TOTAL PERFORMANCE SCORE EXAMPLE 

@Points 

@Proposed © for 

(i) Quality Measure 

Applicable Weight Weighted 

Measures ( percentae:e) Points 

OASIS 

TNC Self-care 7.661 8.75 6.703 

TNC Mobility 5.299 8.75 4.637 

Oral Medications 3.302 5.83 1.925 

Dyspnea 4.633 5.83 2.701 

Discharged to Community 0.618 5.83 0.360 

Claims 

ACH 1.180 26.25 3.098 

ED Use 0.000 8.75 0.000 

HHCAHPS Survey Components 

HHCAHPS Professional Care 10.000 6.00 6.000 

HHCAHPS Communication 10.000 6.00 6.000 

HHCAHPS Team Discussion 10.000 6.00 6.000 

HHCAHPS Overall Rating 5.921 6.00 3.553 

HHCAHPS Willingness to Recommend 8.406 6.00 5.044 

Total Performance Score 100.00 46.021 
35940 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

8. Proposed Payment Adjustment 

Methodology 

We finalized the use of the Linear 

Exchange Function (LEF) for the 

original Model (80 FR 68686) because it 

was the simplest and most 

straightforward option to provide the 

same marginal incentives to all HHAs, 

and we believe the same to be true for 

the HHVBP Model expansion. The LEF 

is used to translate an HHA’s TPS into 

a percentage of the value-based payment 

adjustment earned by each HHA. 

Performance measurement is based on a 

linear exchange function which only 

includes competing-HHAs. 

Under the expanded HHVBP Model, 

we propose to codify at § 484.370 a 

methodology for applying value-based 

payment adjustments to home health 

services. We propose that payment 

adjustments would be made to the HH 

PPS final claim payment amount as 

calculated in accordance with HH PPS 

regulations at § 484.205 using a LEF, 

similar to the methodology utilized by 

the HVBP Program (76 FR 26533). We 

propose the function’s intercept at zero 

percent, meaning those HHAs that have 

a TPS that is average in relationship to 

other HHAs in their cohort would not 

receive any payment adjustment. Under 

this proposal, payment adjustments for 

each HHA with a score above zero 

percent would be determined by the 

slope of the LEF. We propose to set the 

slope of the LEF for the given 

performance year so that the estimated 

aggregate value-based payment 

adjustments for that performance year 

are equal to 5% (the proposed 

maximum payment adjustment for CY 

2024) of the estimated aggregate base 

operating payment amount for the 

corresponding payment year, calculated 

separately for the larger and smaller 

volume cohorts nationwide. The 

estimated aggregate base operating 

payment amount is the total amount of 

payments made to all the HHAs by 

Medicare nationwide in each of the 

larger- and smaller-volume cohorts. 

We propose that the LEF would be 

calculated using the following steps, 

after calculating and ranking the Total 

Performance Score (TPS) (the range of 

the TPS is 0–100) for each HHA in the 

cohort: 

• Step 1, Determine the ‘Prior Year 

Aggregate HHA Payment Amount’ that 

each HHA was paid in the prior year. 

• Step 2, Determine the ‘X-percent 

(the applicable payment year payment 

adjustment percent) Payment Reduction 

Amount’ by multiplying the Prior Year 

Aggregate HHA Payment Amount per 

HHA by the ‘X-percent Reduction Rate’; 

the sum of these amounts is the 

numerator of the LEF. 

• Step 3, Determine the ‘TPS 

Adjusted Reduction Amount’ by 

multiplying the ‘X-percent Payment 

Reduction Amount’ by the TPS/100 . 

The sum of these amounts is the 

denominator of the LEF. 

• Step 4, Calculate the LEF by 

dividing the sum of all HHAs’ ‘Xpercent Payment Reduction Amount’ by 

the sum of the ‘TPS Adjusted Reduction 

Amount’. 

• Step 5, Determine the ‘Final TPS 

Adjusted Payment Amount’ by 

multiplying the LEF by the ‘TPS 

Adjusted Reduction Amount’ for each 

HHA. 

• Step 6, Determine the ‘Quality 

Adjusted Payment Rate’ by dividing the 

‘Final TPS Adjusted Payment Amount’ 

by the ‘Prior Year Aggregate HHA 

Payment Amount’. 

• Step 7, Determine the ‘Final Percent 

Payment Adjustment’ that will be 

applied to the HHA payments by 

subtracting the ‘X-percent Reduction 

Rate’ from the ‘Quality Adjusted 

Payment Rate’. 

Table 32 provides an example of how 

the LEF would be calculated and how 

it would be applied to calculate the 

percentage payment adjustment to an 

HHA’s TPS. For this example, we 

applied the maximum 5-percent 

payment adjustment proposed for the 

expanded HHVBP Model for the CY 

2024 payment year. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.049</GPH>

TABLE 31: HHA E TOTAL PERFORMANCE SCORE EXAMPLE 

@Points for 

@Proposed 

Re- @Re-

(i) Quality Measures 

Applicable Weighting Weighted 

Measures (oercenta~e) Points 

OASIS 

TNC Self-care 7.661 12.5 9.576 

TNC Mobility 5.299 12.5 6.624 

Oral Medications 3.302 8.33 2.751 

Dyspnea 4.633 8.33 3.859 

Discharged to Community 0.618 8.33 0.515 

Claims 

ACH 1.180 37.50 4.425 

ED Use 0.000 12.50 0.000 

HHCAHPS Survey Components 

HHCAHPS Professional Care NIA 0.00 NIA 

HHCAHPS Communication NIA 0.00 NIA 

HHCAHPS Team Discussion NIA 0.00 NIA 

HHCAHPS Overall Rating NIA 0.00 NIA 

HHCAHPS Willingness to Recommend NIA 0.00 NIA 

Total Performance Score 100.00 27.750 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35941 

Step #1 involves the calculation of the 

‘Prior Year Aggregate HHA Payment 

Amount’ (C2 in Table 32) that each 

HHA was paid from claims data under 

the HH PPS in the year prior to the 

performance year. For the CY 2024 

payment year, from claims data, all 

payments are summed together for each 

HHA for CY 2021, the year prior to the 

performance year. 

Step #2 involves the calculation of the 

‘5-percent Payment Reduction Amount’ 

(C3 of Table 32 for each HHA, which is 

calculated by multiplying the ‘Prior 

Year Aggregate HHA Payment Amount’, 

from Step #1 by the ‘5-percent Payment 

Reduction Rate’. The aggregate of the ‘5- 

percent Payment Reduction Amount’ is 

the numerator of the LEF. 

Step #3 involves the calculation of the 

‘TPS Adjusted Reduction Amount’ (C4 

of Table 32) by multiplying the ‘5- 

percent Payment Reduction Amount’ 

from Step #2 by the TPS (C1) divided 

by 100. The aggregate of the ‘TPS 

Adjusted Reduction Amount’ is the 

denominator of the LEF. 

Step #4 involves calculating the LEF 

(C5 of Table 32) by dividing the sum of 

‘5- percent Payment Reduction Amount’ 

calculated in Step #2 by the sum of ‘TPS 

Adjusted Reduction Amount’ calculated 

in Step #3. 

Step #5 involves the calculation of the 

‘Final TPS Adjusted Payment Amount’ 

(C6 of Table 32) by multiplying the ‘TPS 

Adjusted Reduction Amount’ from Step 

#3 (C4) by the LEF from Step #4 (C5). 

The ‘Final TPS Adjusted Payment 

Amount’ is an intermediary value used 

to calculate ‘Quality Adjusted Payment 

Rate’. 

Step #6 involves the calculation of the 

‘Quality Adjusted Payment Rate’ (C7 of 

Table 32) by dividing the ‘Final TPS 

Adjusted Payment Amount’ from Step 

#5 by the ‘Prior Year Aggregate HHA 

Payment Amount’ from Step #1. This is 

an intermediary step to determining the 

payment adjustment rate. 

Step #7 involves the calculation of the 

‘Final Percent Payment Adjustment’ (C8 

of Table 32) by subtracting 5 percent 

from ‘Quality Adjusted Payment Rate’. 

The ‘Final Percent Payment Adjustment’ 

would be applied to the HHA payments 

for the payment adjustment year. We 

propose that the payment adjustment 

percentage would be capped at no more 

than plus or minus 5 percent for the 

applicable performance year and the 

payment adjustment would occur on the 

final claim payment amount for the 

applicable payment year. 

We also propose to codify this 

payment methodology policy at 

§ 484.370. We invite comments on this 

proposal. 

9. Performance Feedback Reports 

We propose to use two types of 

reports that would provide information 

on performance and payment 

adjustments under the expanded 

HHVBP Model. These reports would 

mirror those we have distributed to 

HHAs under the original Model. 

a. Proposed Interim Performance Report 

The first report is the Interim 

Performance Report (IPR) that would be 

distributed to HHAs quarterly. The IPR 

would contain information on the 

interim quality measure performance 

based on the 12 most recent months of 

data available. The IPR would provide 

feedback to HHAs regarding 

performance relative to quality measure 

achievement thresholds and 

benchmarks and would provide 

competing HHAs the opportunity to 

assess and track their performance 

relative to their peers and their own past 

performance. HHAs would receive both 

a preliminary and final version of the 

IPR each quarter. The Final IPR would 

become available, as soon as 

administratively feasible, after the 

preliminary IPR is distributed and after 

recalculation requests are processed, in 

accordance with the process in section 

III.A.10. of this proposed rule (Appeal 

Processes). 

Beginning with the data collected 

during the first quarter of CY 2022 (that 

is, data for the period January 1, 2022 

to March 31, 2022), and for every 

quarter of the expanded HHVBP Model 

thereafter, we propose to provide each 

HHA with an IPR that contains 

information on its performance during 

the 12 most recent months of data 

available. We propose to provide the 12 

most recent months of data because the 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.050</GPH>

TABLE 32: 5-PERCENT REDUCTION SAMPLE 

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 

HHA TPS Prior Year 5-Percent TPS Linear Final TPS Quality Final 

Aggregate Payment Adjusted Exchange Adjusted Adjusted Percent 

HHA Reduction Reduction Function Payment Payment Payment 

Payment Amount Amount (LEF) Amount Rate Adjustmen 

Amount* (C2*5 (Cl/100)*C3 (Sum of (C4*C5) (C6/C2) t +!-

percent) C3/ (C7-5%) 

Sum ofC4) 

(Cl) (C2) (C3) (C4) (C5) (C6) (C7) (CS) 

HHAl 38 $100,000 $5,000 $1,900 1.931 $3,669 3.669% -1.331% 

HHA2 55 $145,000 $7,250 $3,988 1.931 $7,701 5.311% 0.311% 

HHA3 22 $800,000 $40 000 $8,800 1.931 $16,995 2.124% -2.876% 

HHA4 85 $653,222 $32 661 $27,762 1.931 $53,614 8.208% 3.208% 

HHA5 50 $190,000 $9,500 $4,750 1.931 $9,173 4.828% -0.172% 

HHA6 63 $340,000 $17 000 $10 710 1.931 $20,683 6.083% 1.083% 

HHA7 74 $660,000 $33 000 $24 420 1.931 $47,160 7.146% 2.146% 

HHA8 25 $564,000 $28 200 $7,050 1.931 $13,615 2.414% -2.586% 

Sum $172,611 $89,379 $172,611 

*Example cases. 
35942 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

34 iQIES manuals are available at https://

qtso.cms.gov/software/iqies/reference-manuals. 

OASIS and claims data are available 

with different lag times and measures 

are reported in 12-month intervals on 

Care Compare. By using 12 months of 

data, we are able to remove seasonality 

issues and help to ensure a sufficient 

number of cases to provide meaningful 

information to HHAs. By providing 

HHAs with the most recent 12 months 

of data, the IPRs provide as close to realtime performance information as 

possible. We expect to make the first 

IPR available in July 2022 and make 

IPRs for subsequent quarters available in 

October, January, and April. The July 

2022 IPR would be the first IPR issued 

that includes CY 2022 performance year 

data for the first quarter quality measure 

performance scores on the proposed 

OASIS-based measures and baseline 

data for the HHCAHPS survey and 

claims-based measures. We propose that 

the IPRs would include a competing 

HHA’s expanded HHVBP Modelspecific performance results with a 

comparison to other competing HHAs 

within its applicable nationwide cohort 

(larger- or smaller-volume). We propose 

that the IPRs would be made available 

to each HHA through a CMS data 

platform, such as the internet Quality 

Improvement and Evaluation System 

(iQIES), and would include each HHA’s 

relative estimated ranking amongst its 

cohort along with measurement points 

and total performance score based on 

the 12 most recent months of data 

available. We note that the IPRs would 

likely differ from the final data used to 

assess performance during a given 

performance year because the time 

periods used to develop the IPR data 

(the 12 most recent months) would 

differ from the actual performance years 

under the expanded Model (for 

example, CY 2022 data used to 

determine CY 2024 payment 

adjustments). 

These performance results would 

complement quality data sources 

provided through the iQIES and other 

quality tracking systems possibly being 

employed by HHAs to help drive quality 

improvement. The iQIES-generated 

reports would provide quality data 

earlier than the expanded HHVBP 

Model-specific performance reports 

(that is, IPR or Annual) because iQIESgenerated reports are not limited by a 

quarterly run-out of data and a 

calculation of competing peer-rankings. 

The primary difference between iQIESgenerated reports and expanded HHVBP 

Model-specific performance reports is 

that the Model-specific performance 

report we propose would consolidate 

the applicable performance measures 

used in the expanded HHVBP Model, 

provide a peer-ranking to other 

competing HHAs within the same 

volume-based cohort, and provide the 

TPS based on the interim data. In 

addition, Model-specific performance 

reports would provide the competing 

HHAs with a Scorecard and TNC 

Change Reference. The TNC Change 

Reference data would help HHAs gauge 

their performance on the individual 

OASIS items included in the two 

composite measures. It would also tell 

HHAs the percentage of episodes in 

which there was no change, positive 

change, or negative change for each 

OASIS item. The Scorecard would help 

HHAs better understand how each 

individual measure contributes to the 

TPS. For more information on the 

accessibility and functionality of the 

iQIES, please reference the iQIES 

manuals.34 We note that all quality 

measures, except for the TNC Mobility 

and TNC Self-Care measures and the 

HHCAHPS survey measure, in the 

proposed measure set for the CY 2022 

performance year of the expanded 

HHVBP Model are already made 

available in the iQIES. For the 

HHCAHPS survey measure, HHAs can 

access their Data Submission Reports on 

https://homehealthcahps.org under the 

‘‘For HHAs’’ tab. We also suggest HHAs 

contact their survey vendor regarding 

data on the HHCAHPS survey measure. 

We invite public comment on our 

proposals. 

b. Proposed Annual TPS and Payment 

Adjustment Report 

We propose that the second report, 

the Annual TPS and Payment 

Adjustment Report (Annual Report), 

would be made available to each of the 

competing HHAs in approximately 

August of each year preceding the 

payment adjustment year, expected 

beginning in August 2023. We propose 

to make the report available via a CMS 

data platform, such as the iQIES. The 

Annual Report would focus primarily 

on the HHA’s payment adjustment 

percentage for the upcoming CY and 

include an explanation of when the 

adjustment would be applied and how 

this adjustment was determined relative 

to the HHA’s performance scores. Each 

competing HHA would receive its own 

confidential Annual Report viewable 

only to that HHA. We propose that the 

Annual Report would have three 

versions: A Preview Annual Report, a 

Preliminary Annual Report (if 

applicable), and a Final Annual Report. 

We would make available to each 

competing HHA the Preview Annual 

Report in approximately August of each 

year preceding the calendar year for 

which the payment adjustment would 

be applied. We propose that HHAs 

would have 15 days to review and 

request recalculations in accordance 

with the proposed process discussed in 

section III.A.10. of this proposed rule 

(Appeal Processes). For HHAs that 

request a recalculation, we would make 

available a Preliminary Annual Report 

as soon as administratively feasible after 

the recalculation request is processed. If 

we do not receive a recalculation 

request as a result of the Preview 

Annual Report, a Preliminary Annual 

Report would not be issued. We propose 

that HHAs that receive a Preliminary 

Annual Report would have 15 days to 

review and submit a reconsideration 

request in accordance with the proposed 

process discussed in section III.A.10. of 

this proposed rule (Appeal Processes). 

As under the original Model, we 

propose to make available the Final 

Annual Report after all reconsideration 

requests are processed and no later than 

30 calendar days before the payment 

adjustment takes effect annually, both 

for those HHAs that requested a 

reconsideration and all other competing 

HHAs. 

Under this proposed approach, HHAs 

would be notified in advance of the first 

annual total performance score and 

payment adjustment being finalized for 

CY 2024. The total performance score 

and payment adjustment would be 

based on the CY 2022 performance year 

(January 1, 2022 to December 31, 2022), 

with the first payment adjustment to be 

applied to each HH PPS final claim 

payment amount as calculated in 

accordance with HH PPS policies as 

codified at § 484.205 for HHA services 

furnished January 1, 2024 through 

December 31, 2024. 

Subsequent payment adjustments 

would be calculated based on the 

applicable full calendar year of 

performance data from the final IPRs, 

with competing HHAs notified and 

payments adjusted, respectively, every 

year thereafter. As a sequential example, 

the second payment adjustment would 

apply for services furnished January 1, 

2025 through December 31, 2025, based 

on a full 12 months of the CY 2023 

performance year. Notification of the 

second pending payment adjustment 

would occur in approximately August 

2024 when the Preview Annual Report 

is issued, followed by the Preliminary 

(if applicable) and Final Annual 

Reports, as described previously. 

Data related to performance on quality 

measures would continue to be 

provided for the baseline year and all 

performance years of the expanded 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35943 

Model via a CMS data platform, such as 

the iQIES (this platform would present 

and might archive the previously 

described IPR and Annual Reports). 

Table 33 is a sample timeline showing 

the availability of each expanded 

HHVBP Model-specific performance 

report and the data included for the CY 

2022 performance year and CY 2024 

payment year. 

We seek public comment on our 

proposals related to the Interim 

Performance and Annual Reports. 

10. Appeals Processes 

As codified at § 484.335, the appeals 

process under the original HHVBP 

Model allows HHAs to submit 

recalculation requests for the IPRs and 

Annual TPS and Payment Adjustment 

Report. Under this process, an HHA 

may also make a reconsideration request 

if it disagrees with the results of a 

recalculation request for the Annual 

TPS and Payment Adjustment Report. 

We refer the reader to the CY 2017 HH 

PPS final rule for further discussion of 

the appeals process under the original 

HHVBP Model (81 FR 76747 through 

76750). 

Under the expanded Model, we 

propose to use the same appeals process 

as the original Model. We propose that 

competing HHAs be provided the 

opportunity to appeal certain 

information provided in the IPRs and 

the Annual Report, as discussed in more 

detail in the following sections. 

a. Proposed Recalculation Request 

Process 

Under the expanded HHVBP Model, 

we propose that HHAs be provided two 

separate opportunities to review scoring 

information and request recalculations. 

HHAs would have the opportunity to 

request a recalculation if a discrepancy 

is identified due to a CMS error in 

calculations after review of their: (1) 

Preliminary IPRs following each 

quarterly posting; or (2) Preview Annual 

Report. Specifically, we propose that an 

HHA would have 15 calendar days from 

the date either the Preliminary IPR or 

the Preview Annual Report is provided 

to request a recalculation of measure 

scores if it believes there is evidence of 

a discrepancy in the calculation of the 

measure. We propose that we would 

adjust the score if it is determined that 

the discrepancy in the calculated 

measure scores was the result of our 

failure to follow measurement 

calculation protocols. An HHA would 

also have the opportunity to request 

recalculation if it wishes to dispute the 

application of the formula to calculate 

the payment adjustment percentage. 

Under this proposal, for both the 

Preliminary IPRs and the Preview 

Annual Report, competing HHAs would 

only be permitted to request scoring 

recalculations or, for the Preview 

Annual Report, to dispute the 

application of the formula used to 

calculate the payment adjustment 

percentage, and must include a specific 

basis for the requested recalculation. 

Any changes to underlying measure 

data cannot be made. We would not 

provide HHAs with the underlying 

source data utilized to generate 

performance measure scores. 

We propose that HHAs that choose to 

request a recalculation would submit 

recalculation requests for both quarterly 

Preliminary IPRs and for the Preview 

Annual Reports via instructions 

provided on a CMS web page. We 

propose that the request form would be 

entered by the primary point of contact, 

a person who has authority to sign on 

behalf of the HHA. 

We propose that recalculation 

requests (quarterly Preliminary IPR or 

Preview Annual Report recalculations) 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.051</GPH>

TABLE 33: SAMPLE TIMELINE FOR CY 2022 PERFORMANCE YEAR AND 

CY 2024 PAYMENT YEAR BY REPORT TYPE AND DATA TYPE 

Report Type Claims-Based and 

(Approximate Date OASIS-Based Measures HHCAHPS-Based 

Issued) Measures 

July 2022 IPR 12 months ending Baseline data only 

(July 2022) 3/31/2022 

October 2022 IPR 

12 months ending 12 months ending 

(Oct 2022) 

6/30/2022 3/31/2022 

January 2023 IPR 12 months ending 12 months ending 

(Jan 2023) 9/30/2022 6/30/2022 

April 2023 IPR 12 months ending 12 months ending 

(April 2023) 12/31/2022 9/30/2022 

July 2023 IPR 12 months ending 12 months ending 

(July 2023) 3/31/2023 12/31/2022 

Annual TPS and Payment 12 months ending 12 months ending 

Adjustment Report (Aug 12/31/2022 12/31/2022 

2023)* 

*The Annual Report made available to HHAs in approximately August 2023 is the Preview Annual Report. The 

Final Annual Report is issued after the recalculation and reconsideration request periods and no later than 30 days 

prior to the calendar year which the payment adjustment will take effect. 
35944 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

must contain all of the following 

information: 

• The provider’s name, address 

associated with the services delivered, 

and CMS Certification Number (CCN). 

• The basis for requesting 

recalculation to include the specific 

data that the HHA believes is inaccurate 

or the calculation the HHA believes is 

incorrect. 

• Contact information for a person at 

the HHA with whom CMS or its agent 

can communicate about this request, 

including name, email address, 

telephone number, and mailing address 

(must include physical address, not just 

a post office box). 

• A copy of any supporting 

documentation the HHA wishes to 

submit in electronic form via the Modelspecific web page. 

Following receipt of a recalculation 

request, we propose that CMS or its 

agent would— 

• Provide an email acknowledgement, 

using the contact information provided 

in the recalculation request, to the HHA 

contact notifying the HHA that the 

request has been received; 

• Review the request to determine 

validity, and determine whether the 

requested recalculation results in a 

score change altering performance 

measure scores or the HHA’s TPS; 

• If the recalculation request results 

in a performance measure score change, 

conduct a review of data and if an error 

is found, recalculate the TPS using the 

corrected performance data; and 

• Provide a formal response to the 

HHA contact, using the contact 

information provided in the 

recalculation request, notifying the HHA 

of the outcome of the review and 

recalculation process. The Final IPR and 

Preliminary Annual Report would 

reflect any changes noted from 

recalculation process. As under the 

original Model, we anticipate providing 

this response as soon as 

administratively feasible following the 

submission of the request. 

We are also proposing to codify the 

proposed recalculation process at 

§ 484.375(a). We invite comment on our 

proposals. 

b. Proposed Reconsideration Process 

Under the expanded Model, we 

propose that if we determine that the 

original calculation was correct and 

deny the recalculation request for the 

scores presented in the Preview Annual 

Report, or if the HHA otherwise 

disagrees with the results of a CMS 

recalculation as reflected in the 

Preliminary Annual Report, the HHA 

may submit a reconsideration request 

for the Preliminary Annual Report. We 

propose that an HHA may request 

reconsideration of the outcome of a 

recalculation request for its Preliminary 

Annual Report only. We believe that the 

ability to review the IPRs and submit 

recalculation requests on a quarterly 

basis provides competing HHAs with a 

mechanism to address potential errors 

in advance of receiving their Preview 

Annual Report. Therefore, we expect 

that in many cases, the reconsideration 

request process proposed would result 

in a mechanical review of the 

application of the formulas for the TPS 

and the LEF, which could result in the 

determination that a formula was not 

accurately applied. 

Under this proposal, the 

reconsideration request and supporting 

documentation would be required to be 

submitted via instructions provided on 

the CMS web page within 15 calendar 

days of CMS’ notification to the HHA 

contact of the outcome of the 

recalculation request for the Preview 

Annual Report. This proposed 

timeframe would allow a decision on 

the reconsideration to be made prior to 

the generation of the final data files 

containing the payment adjustment 

percentage for each HHA and the 

submission of those data files to the 

Medicare Administrative Contractors 

(MACs) to update their provider files 

with the payment adjustment 

percentage. We believe that this would 

allow for finalization of the annual 

performance scores, TPS, and annual 

payment adjustment percentages in 

advance of the application of the 

payment adjustments for the applicable 

performance year. Reconsiderations 

would be conducted by a CMS 

designated official who was not 

involved with the original recalculation 

request. 

We propose that the final TPS and 

payment adjustment percentage be 

provided to competing HHAs in a Final 

Annual Report no later than 30 calendar 

days in advance of the payment 

adjustment taking effect to account for 

unforeseen delays that could occur 

between the time the Annual Reports 

are posted and the appeals process is 

completed. 

We are also proposing to codify the 

proposed reconsideration process at 

§ 484.375(b). 

We are soliciting comments on these 

proposals. 

11. Public Reporting Under the 

Expanded HHVBP Model 

a. Background 

Consistent with our discussions on 

public reporting under the original 

Model in prior rulemaking, in the CY 

2020 HH PPS final rule (84 FR 60552), 

we finalized a policy to publicly report 

on the CMS website the following two 

points of data from the final CY 2020 

Annual Report for each participating 

HHA in the original Model that 

qualified for a payment adjustment for 

CY 2020: (1) The HHA’s TPS from 

performance year 5; and (2) the HHA’s 

corresponding performance year 5 TPS 

Percentile Ranking. We stated that these 

data would be reported for each such 

competing HHA by agency name, city, 

State, and by the agency’s CCN (84 FR 

60552 through 60553). We refer readers 

to section III.B.3. of this proposed rule, 

where we are proposing to modify our 

public reporting policy for the original 

Model, given our proposal in section 

III.B.2. of this proposed rule to not use 

CY 2020 data to make payment 

adjustments for CY 2022. 

Publicly reporting performance data 

under the expanded Model would 

enhance the current home health public 

reporting processes, as it would better 

inform beneficiaries when choosing an 

HHA, while also incentivizing HHAs to 

improve performance. It would also be 

consistent with our practice of publicly 

reporting performance data under other 

value-based initiatives such as the SNF 

VBP and HVBP Programs (42 CFR 

413.338) (42 CFR 412.163). CMS 

publicly reports both facility-specific 

SNF VBP Program performance 

information (such as achievement 

scores, improvement scores, rankings, 

and incentive payment multipliers), as 

well as aggregate-level program 

performance information on the CMS 

website (42 CFR 413.338). Similarly, for 

the HVBP Program, CMS publicly 

reports quality measures, baseline and 

performance years used, domain scores, 

total performance scores, and aggregate 

payment adjustment amounts on the 

CMS website (42 CFR 412.163). 

Publicly reporting performance data 

for the expanded HHVBP Model would 

also be consistent with other agency 

efforts to ensure transparency and 

publicly report performance data. For 

example, the HH QRP requires HHAs to 

submit data in accordance with 42 CFR 

484.245(b)(1). Furthermore, section 

1895(b)(3)(B)(v)(III) of the Act requires, 

in part, that the Secretary establish 

procedures for making certain HH QRP 

data available to the public. HHAs have 

been required to collect OASIS data 

since 1999 and to report HHCAHPS data 

since 2012 (64 FR 3764 and 76 FR 

68577). These data are available to 

providers, consumers, beneficiaries, and 

other stakeholders on the Care Compare 

Website. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35945 

b. Proposed Public Reporting for the 

Expanded Model 

We believe that publicly reporting 

performance data under the expanded 

HHVBP Model would be an important 

way of incentivizing HHAs to improve 

quality performance under the Model. 

Therefore, we are proposing to publicly 

report performance data for the 

expanded HHVBP Model beginning 

with the CY 2022 performance year/CY 

2024 payment adjustment and for 

subsequent years. For all years of the 

expanded HHVBP Model, we propose to 

publicly report the following 

information: 

• Applicable measure benchmarks 

and achievement thresholds for each 

small- and large-volume cohort. 

• For each HHA that qualified for a 

payment adjustment based on the data 

for the applicable performance year— 

• Applicable measure results and 

improvement thresholds; 

• The HHA’s Total Performance Score 

(TPS); 

• The HHA’s TPS Percentile Ranking; 

and 

• The HHA’s payment adjustment for 

a given year. 

We propose to report these data by 

State, CCN, and agency name through a 

CMS website. We note that quality 

measure results for many of the 

measures proposed to be included in the 

expanded HHVBP Model are already 

currently reported on Care Compare; 

however, we are proposing to also 

separately publicly report applicable 

measure results for such measures in the 

expanded HHVBP Model, because the 

public reporting periods for the Model 

would differ from those used for the HH 

QRP public reporting on Care Compare. 

We believe this would be clear and 

transparent for the public. In addition, 

to the extent that any new measures or 

measures that are otherwise not 

included in the HH QRP and are thus 

not already reported on Care Compare 

are included in the expanded HHVBP 

Model in the future, we propose to 

publicly report those measure results as 

well. 

We would also provide definitions for 

the TPS and the TPS Percentile Ranking 

methodology, as well as descriptions of 

the scoring and payment adjustment 

methodology, on the CMS website to 

ensure the public understands the 

relevance of these data points and how 

they were calculated. We note that this 

information would include a broader 

range of data elements than we 

previously finalized to publicly report 

for the original HHVBP Model. We are 

proposing a broader range of data 

elements for the expanded HHVBP 

Model for several reasons. First, this 

publicly reported information would 

align more closely with the SNF VBP 

and HVBP Programs, both of which 

publicly report a broad range of 

information, including measure results 

and payment adjustment percentages. 

Second, we note that measure results for 

those quality measures included in the 

HH QRP are already publicly reported 

on the Care Compare website. We 

believe that publicly reporting the 

corresponding benchmarks for all 

expanded Model measures (including 

those aligned with the HH QRP as well 

as measures that may not be), by cohort, 

and other quality performance 

information for the expanded HHVBP 

Model would further promote 

transparency and incentivize quality 

improvements under the expanded 

Model. 

We anticipate this information would 

be made available to the public on a 

CMS website on or after December 1, 

2023, the date by which we would 

intend to complete the CY 2022 Annual 

Report appeals process and issuance of 

the Final Annual Report to each 

competing HHA. For each year 

thereafter, we anticipate following the 

same approximate timeline for publicly 

reporting the payment adjustment for 

the upcoming calendar year, as well as 

the related performance data as 

previously described. 

As the expanded Model’s 

performance data would be 

supplemental to the Home Health 

Quality of Patient Care and Patient 

Survey Star Ratings, and does not form 

a part of these or other star ratings, we 

intend to also include a reference to the 

Home Health Star Ratings available on 

the CMS website. 

We also propose to codify these 

proposals at § 484.355(c). 

We seek public comment on these 

proposals. 

12. Extraordinary Circumstances 

Exception Policy 

The nation, its communities, and its 

health care providers, on certain 

occasions, are forced to confront 

extreme and uncontrollable 

circumstances outside of their control 

that impact their ability to operate in the 

ordinary course of business for shortterm, or sometimes even extended 

periods. The United States is currently 

responding to an outbreak of respiratory 

disease caused by a novel coronavirus, 

referred to as COVID–19, which creates 

serious public health threats that have 

greatly impacted the U.S. health care 

system, presenting significant 

challenges for stakeholders across the 

health care delivery system and supply 

chain. Other extraordinary events may 

also occur in the future that have a 

disruptive impact. These events may 

include other public health 

emergencies, large-scale natural 

disasters (such as, but not limited to, 

hurricanes, tornadoes, and wildfires), or 

other extreme and uncontrollable 

circumstances. Such events may strain 

health care resources, and CMS 

understands that HHAs may have 

limited capacity to continue normal 

operations and fulfill expanded HHVBP 

Model participation requirements. In 

situations such as these, we believe 

CMS should make adjustments to the 

requirements of the expanded HHVBP 

Model to ensure the delivery of safe and 

efficient health care. 

Therefore, generally, we propose to 

adopt an extraordinary circumstances 

exception (ECE) policy for the expanded 

HHVBP Model that aligns, to the extent 

possible, with the existing HH QRP 

exceptions and extension requirements 

at 42 CFR 484.245(c). Section 484.245(c) 

permits HHAs to request and CMS to 

grant an exception or extension from the 

program’s reporting requirements in the 

event of extraordinary circumstances 

beyond HHAs’ control. 

Specifically, we are proposing that for 

the expanded HHVBP Model, CMS may 

grant an exception with respect to 

quality data reporting requirements in 

the event of extraordinary 

circumstances beyond the control of the 

HHA. We are proposing that CMS may 

grant an exception as follows: 

• An HHA that wishes to request an 

exception with respect to quality data 

reporting requirements must submit its 

request to CMS within 90 days of the 

date that the extraordinary 

circumstances occurred. Specific 

requirements for submission of a request 

for an exception would be available on 

the CMS website (cms.gov). 

• CMS may grant an exception to one 

or more HHAs that have not requested 

an exception if: CMS determines that a 

systemic problem with CMS data 

collection systems directly affected the 

ability of the HHA to submit data; or if 

CMS determines that an extraordinary 

circumstance has affected an entire 

region or locale. 

We would strive to provide our formal 

response notifying the HHA of our 

decision within 90 days of receipt of the 

HHA’s ECE request, however, the 

number of requests we receive and the 

complexity of the information provided 

would impact the actual timeframe to 

make ECE determinations. When an ECE 

for HHAs in the nation, region or locale 

is granted, CMS would communicate 

the decision through routine channels to 

HHAs and vendors, including, but not 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35946 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

35OASIS is the instrument/data collection tool 

used to collect and report performance data by 

HHAs. 

limited to, the PAC QRP listserv, Open 

Door Forum MLN Connects, and notices 

on the CMS Home Health Quality 

Reporting Spotlight webpage. Specific 

instructions for requesting exceptions or 

extensions would be provided on the 

CMS website. 

We also propose to codify our ECE 

policy at § 484.355(d). 

We seek public comment on our 

proposals. 

B. Provisions Under the Home Health 

Value-Based Purchasing (HHVBP) 

Original Model 

1. Background 

The last year of data collection for the 

original Model ended on December 31, 

2020 and the last payment adjustment 

year of the original Model would end on 

December 31, 2022. Payment 

adjustments are based on each HHA’s 

TPS in a given performance year, which 

is comprised of performance on: (1) A 

set of measures already reported via the 

Outcome and Assessment Information 

Set (OASIS),35 completed Home Health 

Consumer Assessment of Healthcare 

Providers and Systems (HHCAHPS) 

surveys, and select claims data 

elements; and (2) three New Measures 

for which points are achieved for 

reporting data. Payment adjustments for 

a given year are based on the TPS 

calculated for performance two years’ 

prior. Under current policy for the 

original Model, the CY 2022 payment 

adjustments would be based on CY 2020 

(performance year 5) performance. The 

maximum payment adjustment for CY 

2022 is upward or downward 8 percent. 

In the interim final rule with 

comment period that appeared in the 

May 8, 2020 Federal Register (May 2020 

COVID–19 IFC) (85 FR 27553 through 

27554; 85 FR 70328 through 70330), in 

response to the COVID–19 PHE to assist 

HHAs while they direct their resources 

toward caring for their patients and 

ensuring the health and safety of 

patients and staff, we adopted a policy 

to align the original Model data 

submission requirements with any 

exceptions or extensions granted for 

purposes of HH QRP during the COVID– 

19 PHE. We also established a policy for 

granting exceptions to the New 

Measures data reporting during the 

COVID–19 PHE, including the 

codification of these changes at 

§ 484.315(b). 

The original Model utilizes some of 

the same quality measure data that are 

reported by HHAs for the HH QRP, 

including HHCAHPS survey data. The 

other measures used in the original 

Model are calculated using OASIS data; 

claims-based data; and New Measure 

data. In response to the COVID–19 PHE, 

on March 27, 2020, CMS issued public 

guidance (https://www.cms.gov/files/ 

document/guidance-memo-exceptionsand-extensions-quality-reporting-andvalue-based-purchasing-programs.pdf) 

excepting HHAs from the requirement 

to report HH QRP data for Q4 2019 and 

Q1–Q2 2020. Under our policy to align 

the original Model data submission 

requirements with any exceptions or 

extensions granted for purposes of the 

HH QRP during the COVID–19 PHE, 

HHAs in the nine original Model States 

were not required to separately report 

measure data for these quarters for 

purposes of the original Model. Specific 

to the original Model, we granted an 

exception for reporting New Measures 

data for the April 2020 (data collection 

period October 1, 2019–March 31, 2020) 

and July 2020 (data collection period 

April 1, 2020–June 30, 2020) New 

Measure submission periods. We further 

noted that HHAs may optionally submit 

part or all of these data by the 

applicable submission deadlines. 

We acknowledged that the exceptions 

to the HH QRP reporting requirements, 

as well as the modified submission 

deadlines for OASIS data and our 

exceptions for the New Measures 

reporting requirements, may impact the 

calculation of performance under the 

original Model for performance year 5 

(CY 2020). We also noted that while we 

are able to extract the claims-based data 

from submitted Medicare FFS claims, 

we may need to assess the 

appropriateness of using the claims data 

submitted for the period of the COVID– 

19 PHE for purposes of performance 

calculations under the original Model. 

We further explained that we are 

evaluating possible changes to our 

payment methodologies for CY 2022 in 

light of this more limited data, such as 

whether we would be able to calculate 

payment adjustments for participating 

HHAs for CY 2022, including those that 

continue to report data during CY 2020, 

if the overall data is not sufficient, as 

well as whether we may consider a 

different weighting methodology given 

that we may have sufficient data for 

some measures and not others. We 

stated that further, we are also 

evaluating possible changes to our 

public reporting of CY 2020 

performance year data. We stated that 

we intend to address any such changes 

to our payment methodologies for CY 

2022 or public reporting of data in 

future rulemaking. 

2. Proposal on CY 2022 Payment 

Adjustments 

For the reasons discussed in this 

section, we are proposing not to use the 

CY 2020 (performance year 5) data for 

purposes of payment adjustments under 

the HHVBP Model and to instead end 

the original Model early, with the CY 

2021 payment year. Specifically, we are 

proposing that we would not use the 

annual TPS calculated using the 

performance year 5 data to apply 

payment adjustments for CY 2022 and 

to instead end the original Model early, 

such that HHAs in the nine original 

Model States would not have their HH 

PPS claims payments adjusted by the 

current maximum payment adjustment 

factor of upward or downward 8 percent 

in CY 2022. 

In light of the data reporting 

exceptions under the HHVBP Model for 

Q1 and Q2 2020 in response to the 

COVID–19 PHE, as discussed 

previously, we reviewed available 

quality data from Q1 and Q2 2020 as 

compared to Q1 and Q2 2019 for the 

nine original Model States to determine 

whether it may be appropriate to use 

data from the time period during which 

data reporting exceptions were in place 

(Q1 and Q2 2020). The comparison 

showed a decrease of 8.9 percent in 

OASIS assessments. We could not 

directly compare HHCAHPS results 

from Q1 and Q2 because our data are 

calculated on a 12-month rolling basis. 

However, we also examined claims data 

during this same time period to 

determine whether volume and 

utilization patterns changed and 

observed a 20.2 percent decrease in 

claims-based home health stays in Q1 

and Q2 2020 as compared to Q1 and Q2 

2019. The change in volume and 

utilization was observed across time 

(that is, the change was not limited to 

a certain point of time during the Q1 

and Q2 2020 time period) and within 

and across States. We believe these 

changes could be the result of the 

impacts of the COVID–19 PHE, 

including patients avoiding care or 

dying, reduced discharges to the home, 

and increased use of telehealth in lieu 

of in-person home health care. We also 

observed a 10.5 percent decrease in New 

Measures data submissions for Q1 and 

Q2 2020 as compared to Q1 and Q2 

2019, consistent with what we would 

expect given the New Measures 

reporting exceptions we issued for this 

time period. 

Based on the patterns we observed for 

the first two quarters of CY 2020, we do 

not believe it would be appropriate to 

utilize data from that time period to 

calculate a TPS for CY 2020 that would 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35947 

be used to make payment adjustments 

in CY 2022. The changes in volume and 

utilization could skew performance 

assessments on quality measures for 

HHAs, such that the calculated TPS may 

not accurately reflect the quality of care 

provided by the HHAs. Additionally, we 

are concerned that because the COVID– 

19 PHE has not impacted all HHAs 

equally, implementing payment 

adjustments based on the impacted data 

for the period of the COVID–19 PHE 

could unfairly penalize certain HHAs. 

We also considered whether to use 

only Q3 and Q4 CY 2020 quality 

measure data to calculate CY 2020 

annual total performance scores for CY 

2022 payment adjustments. However, 

we believe that using only two quarters 

of data may not be sufficiently 

representative of the care provided by 

the HHA during a given calendar year 

for purposes of calculating quality 

measure scores and determining 

payment adjustments under the Model, 

and could potentially disadvantage 

those HHAs in an area of a State more 

heavily affected by the pandemic in Q3 

and Q4 of CY 2020. In addition, as 

HHAs in different States continued to be 

impacted by the COVID–19 PHE during 

the second half of CY 2020, we believe 

patterns of home health care may also 

have continued to be impacted during 

that timeframe, similar to the changes 

we observed for the Q1 and Q2 2020 

time period. As more data become 

available from the latter half of CY 2020, 

we will continue to examine home 

health care patterns in the nine original 

Model States in order to determine 

whether the same patterns we observed 

in the Q1 and Q2 2020 data persisted 

into the latter half of the year, and to 

assess whether it would be appropriate 

to utilize such data for CY 2022 

payment adjustments. Finally, we note 

that several commenters on the 

exceptions policies that we adopted in 

the May 2020 COVID–19 IFC requested 

that we not use any performance data 

from CY 2020 and terminate or suspend 

the original Model early (85 FR 70328 

through 70330). 

After consideration of these issues, we 

are proposing to not apply any payment 

adjustments for CY 2022 of the original 

HHVBP Model based on data reported 

in CY 2020 and to instead end the 

original Model early, with the CY 2021 

payment adjustment year. As noted, we 

will continue to examine data for CY 

2020 as it becomes available in order to 

determine whether it would be 

appropriate to utilize such data for CY 

2022 payment adjustments, in 

accordance with current Model policies. 

We will also continue to provide HHAs 

with the Interim Performance Reports 

with CY 2020 performance data and the 

Annual Report with the calculated TPS 

and payment adjustment amount based 

on the CY 2020 performance data, 

consistent with our current policies. If 

we finalize our proposal, as previously 

discussed, we would not use the TPS 

calculated using the performance year 5 

data to apply payment adjustments for 

CY 2022. 

We note that if we finalize this 

proposal to end the original Model 

early, the evaluation would include the 

period through CY 2019 (performance 

year 4) and CY 2021 (payment year 4). 

As we are proposing to not use CY 2020 

(performance year 5) data to calculate 

CY 2022 (payment year 5) payment 

adjustments, these years would not be 

evaluated. 

We believe that our proposed policy 

to not use CY 2020 performance year 

data to determine payment adjustments 

under the HHVBP Model would be 

consistent with how other quality 

reporting and VBP programs are 

proposing to utilize data that has been 

significantly affected by circumstances 

caused by the COVID–19 PHE. In the FY 

2022 Hospice proposed rule (86 FR 

19755), we proposed to modify the HH 

QRP public display policy to display 

fewer quarters of data than what was 

previously finalized for certain HH QRP 

measures for the January 2022 through 

July 2024 refreshes (86 FR 19755 

through 19764). For the January 2022 

refresh, data for OASIS-based and 

certain claims-based measures would 

include Q3 2020 through Q1 2021 data. 

For HHCAHPS, data would cover the 

four quarters Q3 2020 through Q2 2021. 

We note that Q1 2020 and Q2 2020 data 

would not be included in the proposed 

Care Compare refresh schedule for any 

measures. The SNF VBP program 

proposed in the FY 2022 SNF PPS 

proposed rule (86 FR 19954) to suppress 

the use of the SNF readmission measure 

(SNFRM) for scoring and payment 

adjustment purposes for the FY 2022 

program year. The HVBP program 

proposed in the FY 2022 IPPS/LTCH 

PPS proposed rule (86 FR 25469 

through 25496) to suppress the use of a 

number of measures for the FY 2022 or 

FY 2023 program years for purposes of 

scoring and payment adjustments, along 

with proposals to revise the baseline 

periods for certain measures due to the 

extraordinary circumstances exception 

we granted in response to the COVID– 

19 PHE. 

We are proposing to amend at 

§ 484.305 the definition of ‘‘applicable 

percent’’ by removing paragraph (5) of 

the definition ((5) For CY 2022, 8 

percent) to reflect our proposal not to 

apply any payment adjustments for FY 

2022 and to end the original Model 

early. 

We invite public comment on our 

proposal. 

3. Public Reporting Under the Original 

Model 

In the CY 2020 HHS PPS final rule (84 

FR 60551 through 60553), we finalized 

a policy to publicly report on the CMS 

website the following two points of data 

from the final CY 2020 performance 

year 5 Annual Report for each 

participating HHA in the Model that 

qualified for a payment adjustment for 

CY 2020: (1) The HHA’s TPS from 

performance year 5; and (2) the HHA’s 

corresponding performance year 5 TPS 

Percentile Ranking. We stated that these 

data would be reported for each such 

competing HHA by agency name, city, 

State, and by the agency’s CMS 

Certification Number (CCN). We 

expected that these data would be made 

public after December 1, 2021, the date 

by which we intended to complete the 

CY 2020 Annual Report appeals process 

and issuance of the final Annual Report 

to each HHA. 

For the reasons discussed in section 

III.B.2. of this proposed rule, we are 

proposing to not use CY 2020 data for 

CY 2022 payment adjustments under 

the HHVBP Model. Consistent with this 

proposal, we are also proposing to 

modify our existing policy and not 

publicly report performance data for the 

HHAs included in the original Model. 

We do not believe that it would be 

appropriate to publicly report 

performance data for a time period for 

which HHAs would not be held 

financially accountable for quality, nor 

do we believe that reporting data for this 

time period would assist beneficiaries 

and other public stakeholders in making 

informed choices about HHA selection, 

as the patterns of care during CY 2020 

may not be representative of 

performance under the original Model 

as a whole due to the COVID–19 PHE. 

However, as discussed in section 

III.A.11. of this proposed rule, we are 

proposing to begin public reporting for 

the expanded HHVBP Model with the 

CY 2022 performance year data, 

continuing for all performance years 

thereafter. 

We are proposing to amend § 484.315 

to reflect our proposal not to publicly 

report performance data from the CY 

2020 performance year by removing 

paragraph (d). We seek comments on 

this proposal. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35948 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

36ONC, Draft 2 Trusted Exchange Framework 

and Common Agreement, https://www.healthit.gov/ 

sites/default/files/page/2019-04/ 

FINALTEFCAQTF41719508version.pdf. 

37For other types of actors (health IT developers 

of certified health IT and health information 

network or health information exchange, as defined 

in 45 CFR 171.102), the definition of ‘‘information 

blocking’’ (see 45 CFR 171.103) specifies that the 

actor ‘‘knows, or should know, that such practice 

is likely to interfere with access, exchange, or use 

of electronic health information.’’ 

IV. Home Health Quality Reporting 

Program (HH QRP) and Other Home 

Health Related Provisions 

A. Vaccinations for Home Health 

Agency Health Care Personnel 

Health Care Personnel (HCP) are at 

risk of carrying COVID–19 infection to 

patients, experiencing illness or death 

as a result of COVID–19 themselves, and 

transmitting it to their families, friends, 

and the general public. We believe 

Home Health Agencies should educate 

and promote vaccination among their 

HCP as part of their efforts to assess and 

reduce the risk of transmission of 

COVID–19. HCP vaccination can 

potentially reduce illness that leads to 

work absence and limit disruptions to 

care. Centers for Disease Control and 

Prevention. Overview of Influenza 

Vaccination among Health Care 

Personnel (https://www.cdc.gov/flu/ 

toolkit/long-term-care/why.htm). Data 

from influenza vaccination 

demonstrates that provider uptake of the 

vaccine is associated with that provider 

recommending vaccination to patients, 

Measure Application Committee 

Coordinating Committee Meeting 

Presentation (http://

www.qualityforum.org/Project_Pages/ 

MAP_Coordinating_Committee.aspx). 

We believe HCP COVID–19 vaccination 

among Home Health staff could 

similarly increase uptake among that 

patient population. 

B. Advancing Health Information 

Exchange 

The Department of Health and Human 

Services (HHS) has a number of 

initiatives designed to encourage and 

support the adoption of interoperable 

health information technology and to 

promote nationwide health information 

exchange to improve health care and 

patients’ access to their health 

information. To further interoperability 

in post-acute care settings, CMS and the 

Office of the National Coordinator for 

Health Information Technology (ONC) 

participate in the Post-Acute Care 

Interoperability Workgroup (PACIO) 

(https://pacioproject.org/) to facilitate 

collaboration with industry stakeholders 

to develop Fast Healthcare 

Interoperability Resources (FHIR) 

standards. These standards could 

support the exchange and reuse of 

patient assessment data derived from 

the minimum data set (MDS), inpatient 

rehabilitation facility patient assessment 

instrument (IRF–PAI), long-term care 

hospital continuity assessment record 

and evaluation (LCDS), outcome and 

assessment information set (OASIS), 

and other sources, including the 

Hospice Outcome and Patient 

Evaluation Assessment (HOPE) if 

implemented in the Hospice Quality 

Reporting Program through future 

rulemaking. The PACIO Project has 

focused on FHIR implementation guides 

for functional status, cognitive status 

and new use cases on advance 

directives and speech, and language 

pathology. We encourage PAC provider 

and health IT vendor participation as 

these efforts advance. 

The CMS Data Element Library (DEL) 

continues to be updated and serves as 

the authoritative resource for PAC 

assessment data elements and their 

associated mappings to health IT 

standards such as Logical Observation 

Identifiers Names and Codes and 

Systematized Nomenclature of 

Medicine. The DEL furthers CMS’ goal 

of data standardization and 

interoperability. These interoperable 

data elements can reduce provider 

burden by allowing the use and 

exchange of healthcare data; supporting 

provider exchange of electronic health 

information for care coordination, 

person-centered care; and supporting 

real-time, data driven, clinical decisionmaking. Standards in the Data Element 

Library (https://del.cms.gov/DELWeb/ 

pubHome) can be referenced on the 

CMS website and in the ONC 

Interoperability Standards Advisory 

(ISA). The 2021 ISA is available at 

https://www.healthit.gov/isa. 

The 21st Century Cures Act (Cures 

Act) (Pub. L. 114–255, enacted 

December 13, 2016) requires HHS to 

take new steps to enable the electronic 

sharing of health information ensuring 

interoperability for providers and 

settings across the care continuum. The 

Cures Act includes a trusted exchange 

framework and common agreement 

(TEFCA) provision 36 that will enable 

the nationwide exchange of electronic 

health information across health 

information networks and provide an 

important way to enable bi-directional 

health information exchange in the 

future. For more information on current 

developments related to TEFCA, we 

refer readers to https://

www.healthit.gov/topic/interoperability/ 

trusted-exchange-framework-andcommon-agreement and https://

rce.sequoiaproject.org/. 

The ONC final rule entitled ‘‘21st 

Century Cures Act: Interoperability, 

Information Blocking and the ONC 

Health IT Certification Program’’ (85 FR 

25642) published May 1, 2020, 

(hereinafter ‘‘ONC Cures Act Final 

Rule’’) implemented policies related to 

information blocking required under 

Section 4004 of the 21st Century Cures 

Act. Information blocking is generally 

defined as a practice by a health IT 

developer of certified health IT, health 

information network, health information 

exchange, or health care provider that, 

except as required by law or specified 

by the Secretary of HHS as a reasonable 

and necessary activity that does not 

constitute information blocking, is 

likely to interfere with, prevent, or 

materially discourage access, exchange, 

or use of electronic health 

information.37 For a healthcare provider 

(as defined in 45 CFR 171.102), specifies 

that the provider knows that the 

practice is unreasonable as well as 

likely to interfere with, prevent, or 

materially discourage access (see 45 

CFR 171.103, exchange, or use of 

electronic health information. To deter 

information blocking, health IT 

developers of certified health IT, health 

information networks and health 

information exchanges whom the HHS 

Inspector General determines, following 

an investigation, have committed 

information blocking, are subject to civil 

monetary penalties of up to $1 million 

per violation. Appropriate disincentives 

for health care providers need to be 

established by the Secretary through 

rulemaking. Stakeholders can learn 

more about information blocking at 

https://www.healthit.gov/curesrule/ 

final-rule-policy/information-blocking. 

ONC has posted information resources 

including fact sheets (https://

www.healthit.gov/curesrule/resources/ 

fact-sheets), frequently asked questions 

(https://www.healthit.gov/curesrule/ 

resources/information-blocking-faqs), 

and recorded webinars (https://

www.healthit.gov/curesrule/resources/ 

webinars). 

We invite providers to learn more 

about these important developments 

and how they could affect HHAs. 

C. 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 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35949 

38The HHCAHPS has five component questions 

that together are used to represent one NQFendorsed measure. 

39 Data collection delayed due to the COVID–19 

public health emergency for the TOH-Patient and 

TOH-Provider. 

40 Data collection delayed due to the COVID–19 

public health emergency for the TOH-Patient and 

TOH-Provider. 

41 Ibid. 

42The HHCAHPS has five component questions 

that together are used to represent one NQFendorsed measure. 

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). 

• CY 2021 HH PPS final rule (85 FR 

70326 through 70328). 

2. General Considerations Used for the 

Selection of Quality Measures for the 

HH QRP 

For a detailed discussion of the 

considerations we historically use for 

measure selection for the HH QRP 

quality, resource use, and others 

measures, we refer readers to the CY 

2016 HH PPS final rule (80 FR 68695 

through 68696). In the CY 2019 HH PPS 

final rule with comment (83 FR 56548 

through 56550) we also finalized the 

factors we consider for removing 

previously adopted HH QRP measures. 

3. Quality Measures Currently Adopted 

for the CY 2022 HH QRP 

The HH QRP currently includes 20 

measures for the CY 2022 program year, 

as outlined in Table 28 of the CY 2020 

. HH PPS final rule (84 FR 60555).38 39


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.052</GPH>

TABLE 28: MEASURES CURRENTLY ADOPTED FOR THE CY 2022 HH QRP 

OASIS-based 

Ambulation Improvement in Ambulation/Locomotion (NQF #0167). 

Application of Falls Application of Percent of Residents Exoeriencing One or More Falls with Maior Iniurv (Long Stay) (NQF #0674). 

Application of Functional Application of Percent of Long-Term Care Hospital (L TCH) Patients with an Admission and Discharge Functional 

Assessment Assessment and a Care Plan That Addresses Function rNOF #2631 ). 

Bathing Improvement in Bathing (NUF #0174). 

Bed Transferrin!! Improvement in Bed Transfenin!! (NUF # 0175). 

DRR Drug Regimen Review Conducted With Follow-Up for Identified Issues- Post Acute Care (PAC) HH QRP. 

Drug Education Drug Education on All Medications Provided to Patient/Caregiver during All Episodes of Care. 

Dvspnea Improvement in Dvsonea. 

Influenza Influenza Immunization Received for Current Flu Season 

Oral Medications Improvement in Management of Oral Medications (NQF #0176). 

Pressure Ulcer/Iniurv Changes in Skin Integrity Post-Acute Care 

Timely Care Timely Initiation Of Care rNOF #0526). 

TOH - Provider Transfer of Health Information to Provider-Post-Acute Care40 

TOH-Patient Transfer of Health Information to Patient-Post-Acute Care41 

Claims-based 

ACH Acute Care Hosoitalization During the First 60 Days ofHH (NQF #0171 ). 

DTC Discharge to Communitv-Post Acute Care (PAC) Home Health ffiH) Oualitv Reporting Program (ORP) (NQF #3477) 

ED Use Ememencv Denartment Use without Hospitalization During the First 60 Davs ofHH (NOF #0173 ). 

MSPB Total Estimated Medicare Spending Per Beneficiarv (MSPB}-Post Acute Care (PAC) HH QRP. 

PPR Potentially Preventable 30-Day Post-Discharge Readmission Measure for HH Oualitv Reporting Program. 

IIllCAHPS-based 

CARPS Home Health Survey CARPS® Home Health Care Survey (experience with care) (NQF #0517)42 

- How often the HH team gave care in a professional way. 

- How well did the HH team communicate with patients. 

- Did the HH team discuss medicines, pain, and home safety with patients. 

- How do patients rate the overall care from the HHA. 

- Will oatients recommend the HHA to friends and familv. 
35950 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

43https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/Quality

InitiativesGenInfo/CMS-Quality-Strategy. 

44Home Health Quality Reporting Program 

Measure Calculations and Reporting User’s Manual 

https://www.cms.gov/files/document/hh-qrp-qmusers-manual-v1-addendum.pdf. 

45Analysis of Home Health OASIS episodes from 

2010 to 2019. 

46The truncated coefficient of variation (TCV) is 

the ratio of the standard deviation to the mean of 

the distribution of all scores, excluding the 5 

percent most extreme scores. A small TCV (≤0.1) 

indicates that the distribution of individual scores 

is clustered tightly around the mean value, 

suggesting that it is not useful to draw distinctions 

between individual performance scores. 

47The removal or addition of an item from the 

OASIS instrument is subject to public comment and 

approval from OMB. We cannot cease reporting of 

this measure any earlier given the need to extend 

OASIS–D and submit another PRA package in 

January 2022 for OMB approval for OASIS–E 

beginning January 1, 2023. 

4. Proposed Changes for the HH QRP 

a. Proposal To Remove the Drug 

Education on All Medications Provided 

to Patient/Caregiver Measure Beginning 

With the CY 2023 HH QRP 

The CMS Meaningful Measures 

framework seeks to identify the highest 

priorities for quality measurement and 

improvement and reduce where 

possible the burden on providers and 

clinicians.43 In line with our meaningful 

measures initiative, we are proposing to 

remove the Drug Education on All 

Medications Provided to Patient/ 

Caregiver During All Episodes of Care 

measure from the HH QRP under 

measure removal factor 1: Measure 

performance among HHAs is so high 

and unvarying that meaningful 

distinctions in improvements in 

performance can no longer be made. 

In the CY 2010 HH PPS final rule (74 

FR 58096), we adopted the Drug 

Education on all Medications Provided 

to Patient/Caregiver measure, an OASISbased measure, beginning with the CY 

2010 HH QRP. This process measure 

reports the percentage of home health 

quality episodes during which the 

patient/caregiver was instructed on how 

to monitor the effectiveness of drug 

therapy, how to recognize potential 

adverse effects, and how and when to 

report problems (at the time of or at any 

time since the most recent SOC/ROC 

assessment). This measure is calculated 

using data collected on OASIS Item 

M2016.44

The Drug Education on all 

Medications Provided to Patient/ 

Caregiver measure has very high 

measure performance such that it meets 

our Meaningful Measure Removal 

Factor 1: Measure performance among 

HHAs is so high and unvarying that 

meaningful distinctions in 

improvements in performance can no 

longer be made. The mean and median 

agency performance scores for this 

measure, from January 1, 2019 to 

December 31, 2019 were 97.1 percent 

and 99.2 percent, respectively. The 

mean and median agency performance 

score for this measure in 2010 were 85.4 

percent and 97.0 percent respectively. 

This indicates that an overwhelming 

majority of patients (or their caregivers) 

in an HHA received drug education on 

all medications and demonstrated 

improvement over time. In addition, 

during the same timeframe, the 75th 

percentile measure score (99.9 percent) 

and the 90th percentile measure score 

(100 percent) were statistically 

indistinguishable from each other, 

meaning that measure scores do not 

meaningfully distinguish between 

HHAs.45 Further, the truncated 

coefficient of variation for this measure 

was 0.03, suggesting that it is not useful 

to draw distinctions between individual 

agency performance scores for this 

measure.46

We note that the HH QRP also has 

another measure that we believe better 

addresses the Meaningful Measure area 

of medication management. The 

Improvement in Management of Oral 

Medications (#0176) measure is an 

NQF-endorsed outcome measure that 

assesses the percentage of home health 

quality episodes during which the 

patient improved in the ability to take 

their oral medications correctly. The 

OASIS item used for this measure 

(M2020) is currently collected at Start of 

Care, Resumption of Care and 

Discharge. The M2020 Management of 

Oral Medications assessment item asks 

about the patient’s current ability to 

prepare and take all oral medications 

reliably and safely, including 

administration of the correct dosage at 

the appropriate times/intervals. This 

measure focuses on improving 

medication management through 

medication education provided to the 

patient. The measure performance 

statistics demonstrate good variation 

among providers and room for 

improvement: From January 1, 2019 to 

December 31, 2019, the mean and 

median agency performance scores for 

this measure was 69.4 percent and 71.9 

percent, respectively; the 75th 

percentile measure score (79.7 percent); 

the 90th percentile measure score (87 

percent); and the truncated coefficient 

of variation for this measure was 0.17. 

Thus, we believe this outcome measure 

The Improvement in Management of 

Oral Medications (NQF #0176) both 

better addresses quality issues of 

medication education and has better 

performance measure properties than 

the Drug Education on all Medications 

Provided to Patient/Caregiver process 

measure. Additionally, the Drug 

Education on All Medications Provided 

to Patient/Caregiver during All Episodes 

of Care measure was removed from the 

HH Quality of Patient Care Star Ratings 

in April 2019 (now Care Compare) and 

replaced by the Improvement in 

Management of Oral Medications 

measure (NQF #0176). The removal of 

Drug Education on All Medications 

Provided to Patient/Caregiver process 

measure from the HH Quality of Patient 

Care Star Ratings in April 2019 and 

replacement with the Improvement in 

Management of Oral Medications 

ensured that there was not a gap in this 

important topic area. 

We propose to remove the Drug 

Education on all Medications Provided 

to Patient/Caregiver measure under 

measure removal factor 1: Measure 

performance among HHAs is so high 

and unvarying that meaningful 

distinctions in improvements in 

performance can no longer be made, 

beginning with the CY 2023 HH QRP. 

If finalized as proposed, HHAs would 

no longer be required to submit OASIS 

Item M2016, Patient/Caregiver Drug 

Education Intervention for the purposes 

of this measure beginning January 1, 

2023.47 If finalized as proposed, data for 

this measure would be publicly reported 

on Care Compare through October 1, 

2023, after which it would be removed 

from the site. 

We invite public comments on the 

proposal to remove Drug Education on 

All Medications Provided to Patient/ 

Caregiver During All Episodes of Care 

measure beginning with the CY 2023 

HH QRP. 

b. Proposal To Replace the Acute Care 

Hospitalization During the First 60 Days 

of Home Health (NQF #0171) Measure 

and Emergency Department Use 

Without Hospitalization During the First 

60 Days of Home Health (NQF #0173) 

Measure With the Home Health Within 

Stay Potentially Preventable 

Hospitalization Measure Beginning 

With the CY 2023 HH QRP 

In the CY 2017 HH PPS final rule, we 

finalized a policy for replacing quality 

measures in the HH QRP. Specifically, 

we defined ‘‘replace’’ to mean adopting 

a different quality measure in place of 

a quality measure currently in the HH 

QRP based on one or more of the HH 

QRP’s measure removal factors (81 FR 

76754 through 76754). We are proposing 

to replace the Acute Care Hospital 

During the First 60 Days of Home Health 

(NQF #0171) measure and the 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35951 

48Friedman, B. and J. Basu. The rate and cost of 

hospital readmissions for preventable conditions. 

Med Care Res Rev, 2004. 61(2): p. 225–40. 

49Moy, E., Chang, E., and Barret, M. Potentially 

Preventable Hospitalizations—United States, 2001– 

2009. MMWR, 2013, 62(03);139–143. 

50 Jencks, S.F., M.V. Williams, and E.A. Coleman. 

Rehospitalizations among Patients in the Medicare 

Fee-for-Service Program. New England Journal of 

Medicine, 2009. 360(14): p. 1418–1428. 

51 Ibid. 

52MedPAC, Payment policy for inpatient 

readmissions, in Report to the Congress: Promoting 

Greater Efficiency in Medicare. 2007: Washington 

DC p. 103–120. 

53Wolff, J.L., Meadow, A., Weiss, C.O., Boyd, 

C.M., Leff, B. Medicare Home Health Patients’ 

Transitions Through Acute And Post-Acute Care 

Settings.’’ Medicare Care 11(46) 2008; 1188–1193. 

54Madigan, E.A., N.H. Gordon, et al. 

Rehospitalization in a national population of home 

health care patients with heart failure.’’ Health Serv 

Res 47(6): 2013; 2316–2338. 

55Walsh, E.G., J.M. Wiener, et al. (2012). 

‘‘Potentially avoidable hospitalizations of dually 

eligible Medicare and Medicaid beneficiaries from 

nursing facility and Home- and Community-Based 

Services waiver programs.’’ J Am Geriatric Soc 

60(5): 821–829. 

56Lohman M.C., Cotton, B.P., Zagaria, A.B., Bao, 

Y., Greenberg, R.L., Fortuna, K.L., Bruce, M.L. 

Hospitalization Risk and Potentially Inappropriate 

Medications among Medicare Home Health Nursing 

Patients,(2017) J Gen Intern Med. 32(12):1301–1308. 

57Hua M., Gong, M.N., Brady J., Wunsch, H. Early 

and late unplanned rehospitalizations for survivors 

of critical illness(2015) Critical Care 

Medicine;43(2):430–438. 

58 Dye C., Willoughby D., Aybar-Damali B., Grady 

C., Oran R., Knudson A. Improving Chronic Disease 

Self-Management by Older Home Health Patients 

through Community Health Coaching (2018). Int J 

Environ Res Public Health. 15(4): 660. 

59Lohman M.C., Cotton, B.P., Zagaria, A.B., Bao, 

Y., Greenberg, R.L., Fortuna, K.L., Bruce, M.L. 

Hospitalization Risk and Potentially Inappropriate 

Medications among Medicare Home Health Nursing 

Patients, (2017) J Gen Intern Med. 32(12):1301– 

1308. 60Lind K.D., Noel-Miller C.M., Sangaralingham 

L.R., Shah N.D., Hess E.P., Morin P., Fernanda 

Bellolio M. Increasing Trends in the Use of Hospital 

Observation Services for Older Medicare Advantage 

and Privately Insured Patients. Med Care Res Rev. 

2019. Apr;76(2):229–239. 

61Feng Z., Wright B., Mor V. Sharp rise in 

Medicare enrollees being held in hospitals for 

observation raises concerns about causes and 

consequences. Health Aff (Millwood). 2012. 

Jun;31(6):1251–9. 

62Sabbatini A.K., Wright B. Excluding 

Observation Stays from Readmission Rates—What 

Quality Measures Are Missing, New England 

Journal of Medicine, 31;378(22):2062–2065. 

Emergency Department Use Without 

Hospitalization During the First 60 Days 

of Home Health (NQF #0173) measure 

under measure removal factor 6: A 

measure that is more strongly associated 

with desired patient outcomes for the 

particular topic is available, with the 

Home Health Within Stay Potentially 

Preventable Hospitalization Measure 

beginning with the CY 2023 HH QRP. 

The proposed Home Health Within 

Stay Potentially Preventable 

Hospitalization (which we will refer to 

as the ‘‘PPH’’ measure) measure assesses 

the agency-level risk-adjusted rate of 

potentially preventable inpatient 

hospitalization or observation stays for 

Medicare fee-for-service (FFS) 

beneficiaries that occur within a home 

health (HH) stay for all eligible stays for 

an agency. This proposed measure is 

claims-based, requiring no additional 

data collection or submission burden for 

HHAs. Our approach for defining 

potentially preventable hospital 

admissions is described in more detail 

in this section of this rule in the 

Measure Calculations section. A HH 

stay is defined as a sequence of HH 

payment episodes that are within 2 days 

or fewer from an adjacent payment 

episode. Payment episodes separated 

from other HH payment episodes by 

greater than 2 days are considered 

separate stays. Full details of the PPH 

specifications may be found at 

‘‘Proposed PPH Measure Specifications 

for the CY 2022 HH QRP NPRM’’ at 

https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/HomeHealthQualityInits/ 

Home-Health-Quality-Measures. 

(1) Background 

Hospitalizations among the Medicare 

population are common, costly, and 

often preventable.48 49 50 The Medicare 

Payment Advisory Commission 

(MedPAC) and a study by Jencks et al. 

estimated that 17–20 percent of 

Medicare beneficiaries discharged from 

the hospital were readmitted within 30 

days. Among these hospital 

readmissions, MedPAC has estimated 

that 76 percent were considered 

potentially avoidable and associated 

with $12 billion in Medicare 

expenditures.51 52 An analysis of data 

from a nationally representative sample 

of Medicare FFS beneficiaries receiving 

HH services in 2004 show that HH 

patients receive significant amounts of 

acute and post-acute services after 

discharge from HH care.53 Focusing on 

readmissions, Madigan and colleagues 

studied data on 74,580 Medicare HH 

patients and found that the 30-day 

rehospitalization rate was 26 percent, 

with the largest proportion related to a 

cardiac-related diagnosis (42 percent).54

A study of data on dually eligible 

Medicare and Medicaid beneficiaries 

hospitalizations from nursing home and 

home and community based services 

waiver programs found that 39 percent 

of admissions were potentially 

avoidable.55

Analysis of the home health patient 

population has revealed some key 

factors associated with hospitalizations 

from HH including functional disability, 

primary diagnoses of heart disease, and 

primary diagnosis of skin wounds.56 An 

additional beneficiary characteristic that 

is associated with a potential for 

hospitalization is the time since a 

beneficiary’s most recent 

hospitalization 57 and chronic 

conditions such as chronic obstructive 

pulmonary disease and congestive heart 

failure.58 How HHAs address these 

factors, including how HHAs address 

chronic conditions present before the 

HH stay, can determine whether 

beneficiaries can successfully avoid 

hospitalizations.59 Understanding these 

factors can help HHAs design strategies 

to address avoidable hospitalizations. 

Observation stays are also increasing 

nationally and can have costly financial 

impacts, especially for patients.60 61

Patients admitted for an observation 

stay can often be treated in the same 

medical units and have similar medical 

needs as a patient admitted for inpatient 

care, but the service is billed as 

outpatient services and does not count 

as a referent patient stay in the 

calculations of readmissions.62

Limitation of observation stays should 

be a goal of HHAs along with efforts to 

limit inpatient hospitalizations. 

We have addressed emergency 

department use, hospitalizations, and 

readmissions with a number of home 

health measures. Measures including 

the Acute Care Hospitalization During 

the First 60 Days of Home Health (NQF 

#0171); Emergency Department Use 

without Hospitalization During the First 

60 days of Home Health (NQF #0173); 

and the Potentially Preventable 30-Day 

Post-Discharge Readmission Measure for 

the HH QRP. The HH QRP has long 

sought to address hospitalization and 

emergency department use by home 

health patients since decreasing 

hospitalizations and use of the 

emergency department are important 

areas of quality to promote patient 

health outcomes and reduce 

unnecessary healthcare costs. Before the 

adoption of the Acute Care 

Hospitalization during the First 60 Days 

of Home Health (NQF #0171) and 

Emergency Department Use Without 

Hospitalization During the First 60 days 

of Home Health (NQF #0173) measures, 

the HH QRP utilized OASIS-based 

iterations of these measures. In the CY 

2012 HH PPS Final Rule (76 FR 68526), 

CMS adopted the Emergency 

Department Use Without 

Hospitalization During the First 60 Days 

of Home Health claims-based measure 

to replace the OASIS-based Emergency 

Department Use Without 

Hospitalization measure since the 

claims data offered a more robust source 

of data for the measure. The M2300 item 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35952 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

63National Voluntary Consensus Standards for 

Care Coordination 2012 Draft Technical Report. 

Available from https://www.qualityforum.org/ 

WorkArea/ 

linkit.aspx?LinkIdentifier=id&ItemID=70600. 

64 Ibid. 

65Prevention Quality Indicators Overview. 

Available at: https://www.qualityindicators.

ahrq.gov/modules/pqi_resources.aspx. 

66 Goldfield, N.I., McCullough, E.C., Hughes, J.S., 

et al. Identifying potentially preventable 

readmissions. Health Care Finan. Rev. 30(1):75–91, 

2008. Available from http://www.ncbi.nlm.nih.gov/ 

pmc/articles/PMC4195042/. 

67National Quality Forum: Prevention Quality 

Indicators Overview. 2008. 

68MedPAC: Online Appendix C: Medicare 

Ambulatory Care Indicators for the Elderly. pp. 1– 

12, prepared for Chapter 4, 2011. Available from 

http://www.medpac.gov/documents/reports/Mar11_

Ch04_APPENDIX.pdf?sfvrsn=0. 

69 Gao, J., Moran, E., Li, Y.-F., et al. Predicting 

potentially avoidable hospitalizations. Med. Care 

52(2):164–171, 2014. doi:10.1097/ 

MLR.0000000000000041. 

70Walsh, E.G., Wiener, J.M., Haber, S., et al. 

Potentially avoidable hospitalizations of dually 

eligible Medicare and Medicaid beneficiaries from 

nursing facility and home-and community-based 

services waiver programs. J. Am. Geriatr. Soc. 

60(5):821–829, 2012. doi:10.1111/j.1532– 

5415.2012.03920. 

71https://www.cms.gov/files/document/2019muclistclearancerpt.pdf. 

used to calculate OASIS-based ED Use 

QM was deemed to be insufficiently 

reliable in capturing emergency 

department visits. In the CY 2013 HH 

PPS Final Rule (77 FR 67902), CMS 

adopted the Acute Care Hospitalization 

During the First 60 Days of Home Health 

claims-based measure to replace the 

OASIS-based Acute Care 

Hospitalization measure since it made 

the determination that claims data 

provided a more robust data source for 

accurately measuring acute care 

hospitalizations. 

The Acute Care Hospitalization 

During the First 60 Days of Home Health 

measure (NQF #0171) and Emergency 

Department Use Without 

Hospitalization During the First 60 days 

of Home Health (NQF #0173) measure 

are claims-based and were an 

improvement on addressing issues 

related to emergency department use 

and acute hospitalization but they also 

had limitations related to issues of 

attribution. In prior feedback from an 

NQF technical review panel on the 

Emergency Department Use Without 

Hospitalization During the First 60 days 

of Home Health (NQF #1073), concerns 

were raised regarding the HHAs’ ability 

to prevent an emergency department 

visit, especially for visits that do not 

result in a hospitalization. While some 

evidence suggests that care coordination 

and HHA engagement can impact 

emergency department use by patients, 

experts raised concerns that there were 

several drivers of emergency department 

use outside the control of an HHA that 

could result in an emergency 

department visit.63

Concerns related to attribution were 

also raised by reviewers of the Acute 

Care Hospitalization during the First 60 

Days of Home Health when the measure 

was reviewed for NQF endorsement by 

the Steering Committee at the National 

Voluntary Consensus Standards for Care 

Coordination 2012 meetings. Reviewers 

acknowledged the difficulty in 

determining appropriate attribution for 

hospitalization between different 

providers and settings, especially when 

evaluating all cause hospitalization that 

does not require the reason for 

hospitalization to be related to the 

reason for home health care.64

The proposed PPH measure addresses 

the limitations of the Emergency 

Department Use Without 

Hospitalization During the First 60 Days 

of Home Health (NQF #0173) and Acute 

Care Hospitalization During the First 60 

Days of Home Health measures (NQF 

#0171). First, the PPH proposed 

measure assesses potentially 

preventable observation stays instead of 

just emergency department use. As 

noted previously, observation stays are 

costly clinical events that require a 

patient to be monitored by a medical 

team. Limiting the occurrence of 

avoidable observation stays would 

improve patient outcomes and reduce 

costs. The PPH measure is focused on 

the subset of observation stays that 

technical experts determined could be 

addressed by HHA intervention. 

Similarly, the PPH proposed measure 

focuses on the subset of inpatient 

hospitalizations that could be avoided 

by HHA intervention. We believe the 

proposed PPH measure will better 

provide an assessment on HH quality by 

focusing on observation stays and acute 

hospitalizations that could be prevented 

by HHA intervention. 

Several general methods have been 

developed to assess potentially 

avoidable or preventable 

hospitalizations and readmissions for 

the Medicare population. These include 

the Agency for Healthcare Research and 

Quality’s (AHRQ’s) Prevention Quality 

Indicators,65 approaches developed by 

MedPAC, and proprietary approaches, 

such as the 3MTM algorithm for 

potentially preventable 

hospitalizations.66 67 68 The existing 

literature addresses both hospital 

readmissions more broadly and 

potentially avoidable hospitalizations 

for specific settings like long-term care 

and highlights issues relevant to the 

development of potentially preventable 

hospitalization measures for a postacute care setting such as home 

health.69 70

(2) Stakeholder and Technical Expert 

Panel (TEP) Input 

A TEP convened by our measure 

contractor provided recommendations 

on the technical specifications of this 

proposed measure, including the 

development of an approach to define 

potentially preventable hospital 

admission and observation stays for HH. 

TEP meetings were held in April, June, 

and December 2018. The TEP supported 

the definition of potentially preventable 

developed by the measure development 

team for both inpatient admissions and 

observation stays. The TEP further 

provided extensive guidance in refining 

the list of primary conditions that lead 

to the inpatient admission or 

observation stay that could be 

reasonably deemed preventable by HHA 

intervention. Details from the TEP 

meetings, including TEP members’ 

ratings of conditions proposed as being 

potentially preventable, are available in 

the TEP summary report available on 

the CMS website at https://

www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/MMS/Downloads/PPHTEP-Summary-Report-Final-101019.pdf. 

We also solicited stakeholder 

feedback on the development of this 

measure through a public comment 

period held from November 18 through 

December 16, 2019. The major comment 

received focused on considering the 

implication of implementation of the 

Patient Diagnosis Group Model on the 

specifications of this measure. CMS has 

undertaken a review of the implications 

on the new payment model on this and 

other claims-based QMs in the HH QRP 

and determined that the claims-based 

QMs are not adversely affected by the 

new model. 

(3) Measure Application Partnership 

(MAP) Review 

Our pre-rulemaking process includes 

making publicly available a list of 

quality and efficiency measures, called 

the Measures under Consideration 

(MUC) List that the Secretary is 

considering adopting through the 

Federal rulemaking process for use in 

Medicare programs. This allows multistakeholder groups to provide 

recommendations to the Secretary on 

the measures included on the list. The 

PPH quality measure was published in 

the 2019 MUC list for the HH QRP.71

The PPH quality measure was 

presented to the 2019 NQF-convened 

Measure Application Process (MAP) 

Post-Acute Care/Long-Term Care (PAC– 

LTC) workgroup and the MAP 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35953 

72Agency for Healthcare Research and Quality: 

AHRQ Quality Indicators—Guide to Prevention 

Quality Indicators: Hospital Admission for 

Ambulatory Care Sensitive Conditions. AHRQ Pub. 

No. 02–R0203. Rockville, MD. Agency for 

Healthcare Research and Quality, 2001. 

73https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/Hospital

QualityInits/Measure-Methodology.html. 

74https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/IRFQuality-Reporting/IRF-Quality-Reporting-ProgramMeasures-Information-.html. 

recommended conditional support for 

rulemaking for a single measure under 

consideration for the HH QRP, 

MUC2019–34 PPH. The MAP 

conditionally supported MUC2019–34 

PPH, pending NQF review and 

endorsement. CMS clarified that it 

intends to eventually replace related 

measures, NQF 0171 Acute Care 

Hospitalization during the First 60 Days 

of Home Health and NQF 0173 

Emergency Department Use (ED Use) 

Without Hospitalization During the First 

60 days of Home Health with the PPH 

measure under consideration. 

The MAP agreed that the PPH 

measure adds value to the HH QRP’s 

measure set by adding measurement of 

potentially preventable hospitalizations 

and observation stays that may occur at 

any point in the home health stay. No 

measure in the program currently 

provides this information. 

The MAP encouraged the 

consideration of including Medicare 

Advantage patients in future iterations 

of the measure. CMS is supportive of 

this suggestion when reliable Medicare 

Advantage data is available nationally. 

The MAP also encouraged the NQF AllCause Admissions and Readmissions 

Standing Committee to consider the 

definition for preventable 

hospitalization to ensure HHAs can take 

adequate steps to improve these 

outcomes. The issue of what could be 

determined to be potentially 

preventable by HHAs was discussed 

extensively at multiple TEP meetings. 

The TEP adopted a listing of conditions 

that could be prevented by standard 

care HHAs are required to provide. The 

MAP encouraged CMS to provide 

detailed performance feedback to 

providers to help providers differentiate 

the causes of hospitalizations for quality 

improvement purposes. More 

information about the MAP’s 

recommendations for this measure is 

available at https://www.quality

forum.org/Publications/2020/02/MAP_

2020_Considerations_for_

Implementing_Measures_Final_Report_- 

_PAC_LTC.aspx. 

At the time of the MAP, the initial 

risk-adjustment model tested measure 

validity and reliability as identified in 

the measure specifications document, as 

previously provided. Testing results 

were very strong and showed more 

robust results than outcome measures 

previously finalized through rulemaking 

including the Acute Care 

Hospitalization During the First 60 Days 

of Home Health (NQF # 0171) measure 

and the Emergency Department Use 

Without Hospitalization During the First 

60 days of Home Health (NQF #0173) 

measure. 

(4) Quality Measure Calculation 

We reviewed established scientific 

research, analyzed home health claims 

data, and obtained input from a 

technical expert panel (TEP) to develop 

a definition and list of conditions for 

which types of hospital admissions are 

potentially preventable. The defining of 

potentially preventable hospitalization 

relies on the previously developed 

conceptual framework that certain 

diagnoses, proper management, and care 

of the condition by the home health 

agency, combined with appropriate, 

clearly explained, and implemented 

discharge instructions and referrals, can 

potentially prevent a patient’s 

admission to the hospital. On the basis 

of this framework, the team followed the 

working conceptual definition for 

potentially preventable hospitalizations 

for home health created during the 

development of the HH QRP measure 

Potentially Preventable 30-Day PostDischarge Readmission Measure for HH 

Quality Reporting Program. Although 

not specific to PAC or hospitalizations, 

the team used AHRQ Prevention Quality 

Indicators (PQIs) and Ambulatory Care 

Sensitive Conditions (ACSCs) as a 

starting point for this work. The list of 

ACSCs consists of conditions for which 

hospitalization can potentially be 

prevented, given good outpatient care 

and early intervention.72

We also performed analyses on 

Medicare claims data to identify the 

most frequent diagnoses associated with 

admissions among home health 

beneficiaries, and then applied the 

conceptual potentially preventable 

hospitalization definition to evaluate 

whether these common conditions for a 

hospitalization may be considered 

potentially preventable. This list of 

conditions identified from literature and 

claims analysis formed the preliminary 

potentially preventable hospitalization 

definition. We grouped these conditions 

based on clinical rationale, and the 

major groups are: (1) Inadequate 

management of chronic conditions; (2) 

Inadequate management of infections; 

(3) Inadequate management of other 

unplanned events; and (4) Inadequate 

injury prevention. 

Additional details regarding the 

definition for potentially preventable 

hospitalizations are available in the 

document titled ‘‘Proposed PPH 

Measure Specification for the CY 2022 

HH QRP NPRM’’ available at https://

www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/HomeHealthQualityInits/ 

Home-Health-Quality-Measures. 

This proposed PPH measure is 

focused on inpatient admissions or 

observation stays that are potentially 

preventable (PP) and unplanned. Thus, 

planned admissions are not counted in 

the numerator. Planned inpatient 

admissions and observation stays are 

defined largely by the definition used 

for the Hospital Wide Readmission 73

and Potentially Preventable Within Stay 

Readmission Measure for Inpatient 

Rehabilitation Facilities 74 measures. 

The process for classifying a planned 

inpatient admission or observation stay 

is determined based on the following 

parameters. If an inpatient or outpatient 

claim contains a code for a procedure 

that is frequently a planned procedure, 

then that inpatient admission or 

observation stay is designated a planned 

inpatient admission or observation stay 

and is not included in the numerator. 

Similarly, if an inpatient or outpatient 

claim contains a code for a diagnosis 

that is frequently associated with a 

planned admission, then that inpatient 

admission or observation stay is 

designated to be a planned inpatient 

admission or observation stay and also 

not included in the numerator. 

However, the planned inpatient 

admission or observation stay is 

reclassified as unplanned if the claim 

also contains a code indicating one or 

more acute diagnoses from a specified 

list that is included in the criteria 

material described in the next sentence. 

Full details on the planned admissions 

criteria used, including the CMS 

Planned Readmission Algorithm and 

additional procedures considered 

planned for post-acute care, can be 

found in the document titled ‘‘Proposed 

PPH Measure Specification for the CY 

2022 HH QRP NPRM’’ at https://

www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/HomeHealthQualityInits/ 

Home-Health-Quality-Measures. 

The risk adjustment modeling 

estimates the effects of patient 

characteristics, comorbidities, and select 

health care variables on the probability 

of potentially preventable inpatient 

hospital admission or observation stay. 

More specifically, the risk-adjustment 

model for HHAs entails the following: 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35954 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

75Prior proximal hospitalizations for this 

measure are defined as inpatient stays within 30 

days prior to home health admission. 

76https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/Quality

InitiativesGenInfo/CMS-Quality-Strategy. 

• Demographic characteristics (age, 

sex, original reason for Medicare 

entitlement). 

• Care received during prior proximal 

hospitalization 75 (if applicable) 

(including the length of the 

hospitalization and principal diagnoses 

during the prior proximal 

hospitalization). 

• Other care received within a year of 

stay (including number of prior acute 

discharges, number of outpatient 

emergency department visits, number of 

skilled nursing visits, number of 

inpatient rehabilitation facility visits, 

number of long term care hospital visits, 

and comorbidities from a prior proximal 

hospitalization [if applicable] or other 

visits in the last year). 

The proposed measure is calculated 

using a calendar year of Medicare FFS 

data. In addition, we propose a 

minimum of 20 eligible HH stays as 

defined in the introduction to this 

proposal for public reporting of the 

proposed measure. All HH stays during 

the year time window, except those that 

meet the exclusion criteria, would be 

included in the measure. The PPH 

observation window begins from the 

start of HH stay and spans to 1 day after 

discharge. Data from all HH stays 

beginning from 1/1/2016–12/31/2016 

was used for the PPH measure 

development. For technical information 

about this proposed measure including 

information about the measure 

calculation, risk adjustment, and 

exclusions, we refer readers to our 

Proposed PPH Measure Specification for 

the CY 2022 HH QRP NPRM at https:// 

www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/HomeHealthQualityInits/ 

Home-Health-Quality-Measures. 

To meet the requirements of the CMS 

Meaningful Measures framework which 

seeks to identify the highest priorities 

for quality measurement and 

improvement and to reduce where 

possible the burden on providers and 

clinicians,76 we are proposing to remove 

the Acute Care Hospitalization During 

the First 60 Days of Home Health (NQF 

#0171) measure and the Emergency 

Department Use Without 

Hospitalization During the First 60 days 

of Home Health (NQF #0173) measure 

and replace them with the PPH 

measure. We are proposing to remove 

these two measures from the HH QRP 

beginning with the CY 2023 HH QRP 

under our measure removal Factor 6: A 

measure that is more strongly associated 

with desired patient outcomes for the 

particular topic is available. 

The Acute Care Hospitalization 

During the First 60 Days of Home Health 

(NQF #0171) and Emergency 

Department Use Without 

Hospitalization During the First 60 days 

of Home Health (NQF #0173) measures 

are both claims-based and have some 

notable limitations related to 

appropriate attribution of the acute 

hospitalization or emergency 

department visit to an HHA. These 

measures focus on hospitalization 

regardless of whether a HHA could 

provide care that could prevent the visit 

whereas the proposed PPH measure 

addresses the limitations of these 

measures by focusing on inpatient 

admissions and observation stays that 

research establishes could be prevented 

by HHA care provided to patients they 

serve. 

We propose to remove the Acute Care 

Hospitalization during the First 60 Days 

of Home Health (NQF #0171) measure 

and Emergency Department Use 

Without Hospitalization During the First 

60 days of Home Health (NQF #0173) 

measure and replace them with the 

Home Health Within-Stay Potentially 

Preventable Hospitalization claimsbased measures beginning with the CY 

2023 HH QRP. 

We invite public comments on this 

proposal. 

c. Proposed Schedule for Publicly 

Reporting Quality Measures Beginning 

With the CY 2022 HH QRP 

Section 1899B(g)(1) of the Act 

requires, in part, that the Secretary 

provide for public reporting of PAC 

provider performance, including HHAs, 

on quality measures under section 

1899B(c)(1) of the Act, including by 

establishing procedures for making 

available to the public information 

regarding the performance of individual 

PAC providers with respect to such 

measures. Section 1899B(g)(2) of the Act 

requires, in part, that CMS give HHAs 

opportunity to review and submit 

corrections to the data and information 

to be made public under section 

1899B(g)(1) of the Act prior to such data 

being made public. Section 1899B(g)(3) 

of the Act requires that such procedures 

provide that the data and information 

with respect to a measure and PAC 

provider is made publicly available 

beginning not later than 2 years after the 

applicable specified application date 

applicable to such measure and 

provider. 

In the CY 2018 HH PPS final rule, we 

adopted the Percent of Residents 

Experiencing One or More Falls with 

Major Injury measure beginning with 

the CY 2020 HH QRP under section 

1899B(c)(1)(D) of the Act (82 FR 51727 

through 51730). Under section 

1899B(a)(2)(E)(i)(IV)(bb) of the Act, the 

specified application date for HH QRP 

measures adopted under section 

1899B(c)(1)(D) of the Act is January 1, 

2019; two years after this date is January 

1, 2021. 

We also adopted in the CY 2018 HH 

PPS final rule the Application of 

Percent of Long-Term Care Hospital 

Patients with an Admission and 

Discharge Functional Assessment 

measure beginning with the CY 2020 

HH QRP (82 FR 51722 through 51727) 

under section 1899B(c)(1)(A) of the Act. 

Under section 1899B(a)(2)(E)(i)(I)(cc) of 

the Act, the specified application date 

for HH QRP measures adopted under 

section 1899B(c)(1)(A) of the Act is 

January 1, 2019; two years after this date 

is January 1, 2021. 

We propose to publicly report the 

Percent of Residents Experiencing One 

or More Major Falls with Injury measure 

and Application of Percent of LongTerm Care Hospital Patients with an 

Admission and Discharge Functional 

Assessment and a Care Plan that 

Addresses Function (NQF #2631) 

measure beginning in April 2022. 

As required by section 1899B(g)(2) of 

the Act, to date CMS has made these 

two measures available for review by 

HHAs on the HH confidential feedback 

reports. The Percent of Residents 

Experiencing One or More Major Falls 

with Injury measure was added to the 

HHA Review and Correct Report 

effective 04/01/2019, and the HHA 

Outcome Measures Report effective 01/ 

01/2020. The measure Application of 

Percent of Long-Term Care Hospital 

Patients with an Admission and 

Discharge Functional Assessment and a 

Care Plan that Addresses Function (NQF 

#2631) was added to the HHA Review 

and Correct Report effective 04/01/2019, 

and the HHA Process Measures Report 

effective 01/01/2020. HHAs’ HH QRP 

measure scores for these two measures 

would additionally be made available 

for review on the HH Provider Preview 

Report, which would be issued in 

January 2022, three months in advance 

of the inaugural display of these 

measures on Care Compare. 

We invite public comments on our 

proposed schedule to publicly display 

these measures. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35955 

77https://www.cms.gov/files/document/ 

03092020-covid-19-faqs-508.pdf. 78https://www.healthaffairs.org/do/10.1377/ 

hblog20201214.543463/full/. 79https://www.hartfordbusiness.com/article/ 

demand-for-home-health-care-surges-amid-covid19-shifting-industry-landscape. 

80https://www.forbes.com/sites/sethjoseph/2020/ 

08/05/home-health-care-is-a-bright-light-duringcovid-19-with-an-even-brighter-future/ 

?sh=2bfa2c513891. 

81https://www.wsj.com/articles/demand-for-inhome-care-rises-during-coronavirus-11588003076. 

82https://www.csbj.com/premier/businessnews/ 

healthcare/covid-19-boosts-demand-for-homehealth-care/article_c65d2b4e-3b17-11eb-a46e97a2079b065f.html. 

d. Proposed Revised Compliance Date 

for Certain HH QRP Reporting 

Requirements 

(1) Background 

In the May 8, 2020 Federal Register 

(85 FR 27550), we published an interim 

final rule with comment period 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’’ (which we will 

refer to as ‘‘IFC–2’’). In IFC–2, we 

delayed the compliance date for certain 

reporting requirements under the HH 

QRP (85 FR 27595 through 27596). 

Specifically, we delayed the 

requirement for HHAs to begin reporting 

the Transfer of Health (TOH) 

Information to PAC and the TOH 

Information to Patient-PAC measures 

and the requirement for HHAs to begin 

reporting certain Standardized Patient 

Assessment Data Elements to January 

1st of the year that is at least one full 

calendar year after the end of the 

COVID–19 Public Health Emergency 

(PHE). CMS also delayed the adoption 

of the updated version of the Outcome 

and Assessment Information Set 

(OASIS) assessment instrument 

(OASIS–E) for which HHAs would 

report the Transfer of Health (TOH) 

measures and certain Standardized 

Patient Assessment Data Elements. 

Under IFC–2, HHAs must use OASIS– 

E to begin collecting data on the two 

TOH Information measures beginning 

with discharges and transfers on January 

1st of the year that is at least one full 

calendar year after the end of the 

COVID–19 PHE. HHAs must also begin 

collecting data on certain Standardized 

Patient Assessment Data Elements on 

the OASIS–E, beginning with the start of 

care, resumption of care, and discharges 

(except for the hearing, vision, race, and 

ethnicity Standardized Patient 

Assessment Data Elements, which 

would be collected at the start of care 

only) on January 1st of the year that is 

at least one full calendar year after the 

end of the COVID–19 PHE. The delay to 

begin collecting data for these measures 

was to provide relief to HHAs from the 

added burden of implementing an 

updated instrument during the COVID– 

19 PHE. We wanted to provide 

maximum flexibilities for HHAs to 

respond to the public health threats 

posed by the COVID–19 PHE, and to 

reduce the burden in administrative 

efforts associated with attending 

trainings, training their staff, and 

working with their vendors to 

incorporate the updated assessment 

instruments into their operations. 

At the time we finalized the policy in 

the IFC–2, we believed that the delay in 

collection of the TOH Information 

measures and Standardized Patient 

Assessment Data Elements would not 

have a significant impact on the HH 

QRP. However, the COVID–19 PHE 

showed the important need for these 

TOH Information measures and 

Standardized Patient Assessment Data 

Elements under the HH QRP. The PHE’s 

disproportionate impact on minority 

populations demonstrates the 

importance of analyzing this impact and 

the needs for these populations to 

improve quality of care within HHAs, 

especially during a public health 

emergency. 

(2) Current Assessment of HHAs 

To accommodate the COVID–19 PHE, 

CMS has provided additional guidance 

and as a result HHAs have adopted new 

processes as well as modified existing 

processes. For example, HHAs currently 

have the option to complete what was 

required to be a face-to-face encounter 

to qualify for home health via telehealth 

and the completion of aspects of 

required comprehensive assessments via 

telehealth.77 CMS also supported PAC 

providers, including HHAs, by 

providing requested flexibilities in the 

delivery of care in response to the PHE. 

In addition, we assisted providers by 

conducting sessions for HHAs to share 

best practices that agencies have 

identified to address many of the 

challenges posed by the PHE. 

Based upon other flexibilities such as 

the examples provided and the adoption 

of best practices, and since finalizing 

IFC–2, HHAs are in a better position to 

accommodate reporting of the TOH 

measures and certain Standardized 

Patient Assessment Data Elements. Also, 

recent reports (not available at the time 

CMS IFC–2 was finalized) suggest that 

HHAs have the capacity to begin 

reporting the TOH measures and certain 

Social Determinant of Health (SDOH) 

Standardized Patient Assessment Data 

Elements.78 Since IFC–2 was finalized, 

the industry has identified a growing 

demand for home health services and 

has noted their ability to meet this 

demand.79 80 81 82

In addition, after evaluating the 

impact of the compliance date under 

IFC–2, feasibility around data collection 

by HHAs, and the support needs of 

providers during the COVID–19 PHE, 

we have determined that HHAs now 

have the administrative capacity to 

attend trainings, train their staff, and 

work with their vendors to incorporate 

the updated assessment instrument, the 

OASIS–E into their operations. 

We now believe that based upon the 

processes adopted by HHAs, as 

previously described, the flexibilities 

afforded to HHAs since the beginning of 

the COVID–19 PHE, and the importance 

of the data to the HH QRP, it would be 

appropriate to modify the compliance 

date finalized in IFC–2. This may 

support future activities under 

Executive Order 13985, entitled 

‘‘Advancing Racial Equity and Support 

for Underserved Communities Through 

the Federal Government,’’ issued 

January 20, 2021 (https://www.federal

register.gov/documents/2021/01/25/ 

2021-01753/advancing-racial-equityand-support-for-underservedcommunities-through-the-federalgovernment). 

3. Proposal To Collect the Transfer of 

Health Information to Provider-PAC 

Measure, the Transfer of Health 

Information to Patient-PAC Measure, 

and Certain Standardized Patient 

Assessment Data Elements Beginning 

January 1, 2023 

We are proposing to revise the 

compliance date from IFC–2 to January 

1, 2023. This revised date would begin 

the collection of data on the Transfer of 

Health Information to Provider-PAC 

measure and Transfer of Health 

Information to Patient-PAC measure, 

and certain Standardized Patient 

Assessment Data Elements on the 

updated version of the OASIS 

assessment instrument referred to as 

OASIS–E. This revised date of January 

1, 2023, which is a two-year delay from 

this original compliance date finalized 

in the CY 2020 HH PPS final rule (84 

FR 60557 through 60610), balances the 

support that HHAs needed during much 

of the COVID–19 PHE as CMS provided 

flexibilities to support HHAs along with 

the need to collect this important data. 

The need for the Standardized Patient 

Assessment Data Elements and Transfer 

of Health data have shown to be even 

more pressing with issues of inequities 

that the COVID–19 PHE laid bare. This 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35956 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

data that includes addressing SDOH 

provides information that is expected to 

improve quality of care for all. 

Consequently, we are proposing to 

revise the compliance date to reflect this 

balance and assure that this data 

collection begins on January 1, 2023. 

As stated in the CY 2020 HH PPS final 

rule, CMS will provide the training and 

education for HHAs to be prepared for 

this implementation (84 FR 60554). In 

addition, if CMS adopts a January 1, 

2023 compliance date, CMS would 

release a draft of the updated version of 

the OASIS instrument, OASIS–E, in 

early 2022. 

Based upon our evaluation, we 

propose that HHAs would collect the 

Transfer of Health Information to 

Provider Post-Acute Care measure, the 

Transfer of Health Information to 

Patient-PAC measure, and certain 

Standardized Patient Assessment Data 

Elements beginning January 1, 2023. We 

propose that, accordingly, HHAs would 

begin collecting data on the two TOH 

measures beginning with discharges and 

transfers on January 1, 2023 on the 

OASIS–E. We also propose that HHAs 

would begin collecting data on the six 

categories of Standardized Patient 

Assessment Data Elements on the 

OASIS–E, with the start of care, 

resumption of care, and discharges 

(except for the hearing, vision, race, and 

ethnicity Standardized Patient 

Assessment Data Elements, which 

would be collected at the start of care 

only) beginning on January 1, 2023. 

We invite public comment on these 

proposals. 

D. Proposed Changes to the Home 

Health Conditions of Participation 

1. Background and Statutory Authority 

Since March, 2020, CMS has issued a 

number of regulatory waivers in 

response to the COVID–19 PHE under 

our statutory authority granted by 

section 1135 of the Act. That statute 

permits the Secretary to waive certain 

statutes and regulations during a public 

health emergency declared by the 

President, in order to expand healthcare 

system capacity while continuing to 

maintain public and patient safety, and 

to hold harmless providers and 

suppliers who may be unable to comply 

with existing regulations after a good 

faith effort. Specifically, the Secretary 

may temporarily waive or modify 

certain Medicare, Medicaid, and 

Children’s Health Insurance Program 

(CHIP) requirements to ensure: 

Sufficient health care items and services 

are available to meet the needs of 

individuals enrolled in Medicare, 

Medicaid and CHIP in the emergency 

area during the emergency period. In 

such circumstances, providers can be 

reimbursed and exempted from 

sanctions under these programs (absent 

any determination of fraud or abuse). 

We issued a variety of regulatory 

waivers that pertained to most CMScertified providers and suppliers during 

the COVID–19 PHE, including HHAs. 

Sections 1861(o) and 1891 of the Act 

authorize the Secretary to establish the 

requirements that an HHA must meet to 

participate in the Medicare Program, 

and these conditions of participation 

(CoPs) are set forth in regulations at 42 

CFR part 484. We waived selected 

requirements for HHAs within part 484 

for the duration of the PHE. While some 

of these waivers simply delay certain 

administrative deadlines, others directly 

impact the provision of patient care. We 

have identified waivers related to the 

requirements for the supervision of 

home health aides at § 484.80(h)(1) and 

(2) that we believe would be appropriate 

as permanent policy. These proposed 

changes and their respective 

background information are discussed 

in detail. 

In addition, in order to implement 

section 115 of Division CC of the CAA 

2021, we are proposing to modify the 

requirements for the home health initial 

assessment visit and comprehensive 

assessment. This statutorily-required 

modification allows an occupational 

therapist to complete the initial and 

comprehensive assessments for 

Medicare patients when occupational 

therapy is ordered with another 

rehabilitation therapy service (speech 

language pathology or physical therapy) 

that establishes program eligibility. This 

would only be permitted if skilled 

nursing services have not been ordered. 

2. Provisions of the Proposed 

Regulations 

We propose the following revisions to 

the HHA CoPs. 

a. Home Health Aide Supervision 

Home health aides deliver a 

significant portion of direct home health 

care. Ensuring that aide services are 

meeting the patient’s needs is a critical 

part in maintaining safe, quality care. At 

§ 484.80(h)(1) and (2), we differentiate 

aide supervision requirements based on 

the level of care required by the patient. 

Aides caring for a patient receiving 

skilled care from nurses or therapists 

must currently have an on-site 

supervisory visit every 14 days, while 

aides caring for a patient who is not 

receiving skilled care must have an onsite supervisory visit every 60 days. 

We believe the current 14-day on-site 

supervisory visit requirement when a 

patient is receiving skilled services is an 

important component to assessing the 

quality of care and services provided by 

the HHA aide, and to ensure that aide 

services are meeting the patient’s needs. 

Currently, the regulations require that 

the 14-day supervisory assessment be 

conducted by the registered nurse (RN) 

or other appropriate skilled professional 

who is familiar with the patient, the 

patient’s plan of care and the written 

care instructions as described in 

484.80(g). However, we believe it is 

important to permit HHA’s to complete 

this assessment virtually, in the rare 

circumstance that an onsite visit cannot 

be coordinated within the 14-day time 

period. 

We propose that HHAs be permitted 

to use interactive telecommunications 

systems for purposes of aide 

supervision, on occasion, not to exceed 

2 virtual supervisory assessments per 

HHA in a 60-day period. We are 

proposing to revise the language at 

§ 484.80(h)(1)(i) to require that if a 

patient is receiving skilled care (that is, 

skilled nursing, physical or 

occupational therapy, or speech 

language pathology services), the home 

health aide supervisor (RN or other 

appropriate skilled professional) must 

complete a supervisory assessment of 

the aide services being provided, either 

onsite (that is, an in person visit) or by 

using interactive telecommunications 

systems to ensure aides are furnishing 

care in a safe and effective manner, no 

less frequently than every 14 days. The 

home health aide does not need to be 

present during this supervisory 

assessment. As outlined in regulation at 

§ 484.80(h)(4), the home health aide 

supervisory assessment is required to 

ensure that the aide is furnishing care in 

a safe and effective manner, such as: 

Following the patient’s plan of care for 

completion of tasks assigned to the 

home health aide; maintaining an open 

communication process with the 

patient, representatives, caregivers, and 

family; demonstrating competency with 

assigned tasks; complying with 

infection prevention and control 

policies and procedures; reporting 

changes in the patient’s condition; and 

honoring the patient’s rights. We are 

proposing the define interactive 

telecommunications systems as 

multimedia communications equipment 

that includes, at a minimum, audio and 

video equipment permitting two-way, 

real-time interactive communication 

between the patient and distant site 

physician or practitioner. The use of 

interactive telecommunications systems 

for the aide supervisory assessment 

must not exceed 2 virtual supervisory 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35957 

assessments per HHA in a 60-day 

period, regardless of the number of 

aides or patients associated with a given 

HHA. If the supervising individual 

notes an area of concern during the 14- 

day supervisory assessment, the 

supervising individual must make an 

on-site in-person visit to the location 

where the patient is receiving care while 

the aide is performing care, in order to 

observe and assess the aide as required 

at § 484.80(h)(1)(ii) and (iii). 

While we are proposing to allow this 

flexibility, we expect that in most 

instances, the HHAs would plan to 

conduct the 14-day supervisory 

assessment during an on-site, in person 

visit, and that the HHA would use 

interactive telecommunications systems 

option only for unplanned occurrences 

that would otherwise interrupt 

scheduled in-person visits. Examples of 

circumstances in which a scheduled onsite in-person visit may not be able to 

be rescheduled timely within the 14-day 

window could include a severe weather 

occurrence, a patient requests to change 

the date of the scheduled visit, or 

unexpected staff illness or absence on 

the planned day for the visit. 

We are not proposing changes to the 

requirements for annual aide 

assessments at § 484.80(h)(1)(iii). In 

addition to the regularly-scheduled 14- 

day supervisory assessment and asneeded observation visits for aides 

providing care to patients receiving 

skilled services, HHAs are required to 

make an annual on-site, in person, visit 

to a patient’s home to directly observe 

and assess each home health aide while 

he or she is performing patient care 

activities. The HHA is required to 

observe each home health aide annually 

with at least one patient. 

We are also proposing revisions to the 

supervisory assessment requirements for 

aides providing care to patients who are 

not receiving skilled care services. At 

§ 484.80(h)(2), we currently require that 

if home health aide services are 

provided to a patient who is not 

receiving skilled care, the RN must 

make an on-site visit to the location 

where the patient is receiving care from 

such aide. Such visits must occur at 

least once every 60 days in order to 

observe and assess each home health 

aide while he or she is providing care. 

This supervisory visit must be 

performed by a RN because these 

patients are not otherwise receiving 

HHA services from other professionals, 

such as therapists. We continue to 

receive feedback that this requirement is 

overly burdensome for the patient and 

the HHA if multiple home health aides 

provide care to the same patient. For 

instance, if a patient has three different 

home health aides providing care, the 

nurse is currently required to observe 

and assess each of the three home health 

aides while the aide is giving care to the 

patient. This circumstance would entail 

three separate nursing supervision visits 

on the same patient every 60 days. 

While we believe that the HHA’s 

observation of an aide providing direct 

care to the patient is important to ensure 

quality, requiring a patient to receive 

three separate supervision visits every 

60 days may be onerous on the patient 

and the HHA. 

We propose to maintain the first part 

of this requirement, that the registered 

nurse must make a visit in person every 

60 days, but would remove the 

requirement that the RN must directly 

observe the aide in person during those 

visits. We would accomplish this by 

removing the language from 42 CFR 

484.80(h)(2) that states, ‘‘in order to 

observe and assess each home health 

aide while he or she is performing 

care,’’ and replacing it with ‘‘to assess 

the quality of care and services provided 

by the home health aide and to ensure 

that services meet the patient’s needs’’. 

In addition, we propose to further revise 

the requirement to state that the home 

health aide would not need to be 

present during this visit. We believe that 

these proposed revisions from an on-site 

(direct) observation of each aid while 

performing care to an indirect 

supervision visit to assess the adequacy 

of the aide care plan, the patient’s 

perception of services provided, and 

hear any concerns from the patient; may 

better support the patients’ needs by 

allowing for open communication 

between the nurse and patient. If a 

deficiency in the aide services are 

assessed, the agency must conduct and 

the home health aide must complete, 

retraining and a competency evaluation 

for the deficient and all related skills. 

In order to ensure appropriate RN 

supervision of HHA aides caring for 

patients who are not receiving skilled 

services, we propose to add a new 

requirement to 42 CFR 484.80(h)(2) that 

would require the RN to make a semiannual on-site visit to the location 

where a patient is receiving care in 

order to directly observe and assess each 

home health aide while he or she is 

performing care. This semi-annual inperson assessment would occur twice 

yearly for each aide, regardless of the 

number of patients cared for by that 

aide. 

Supervisory visits allow professionals 

to evaluate whether aides are providing 

appropriate care as ordered by the 

patient’s plan of care. When RNs or 

qualified professionals identify a 

deficiency in aide services, 

§ 484.80(h)(3) requires that the agency 

conduct, and the home health aide 

complete, retraining and a competency 

evaluation related to the deficient 

skill(s). 

We propose to maintain this 

requirement at 484.80(h)(3), but to 

modify it by adding ‘‘and all related 

skills.’’ We believe that when a deficient 

area(s) in the aide’s care are assessed 

and verified by the RN, additional 

related competencies may reflect 

deficient practice areas that should be 

addressed. For example, if the patient 

informs the nurse that they almost fell 

when the aide was transferring them 

from bed to a chair, the nurse should 

assess the aide’s technique for 

transferring a patient in other 

circumstances beyond transfer to a 

chair, such as transferring from a bed to 

bedside commode or to a shower chair. 

We request public comment on our 

proposed changes to allow virtual 

supervisory assessments of home health 

aides for patients receiving skilled care 

at § 484.80(h)(1)(i), and for the proposed 

changes to supervision, competency 

assessment, and retraining for aides 

providing care to patients receiving all 

levels of HHA care. We especially 

welcome comments from patients and 

caregivers who have experienced virtual 

supervisory assessments of home health 

aides during the PHE. 

b. Permitting Occupational Therapists 

To Conduct the Initial Assessment Visit 

and Complete the Comprehensive 

Assessment for Home Health Agencies 

Under the Medicare Program 

On December 27, 2020, the CAA, 2021 

was signed into law. Division CC, 

section 115 of the CAA 2021 requires 

CMS to permit an occupational therapist 

to conduct the initial assessment visit 

and complete the comprehensive 

assessment under the Medicare 

program, but only when occupational 

therapy is on the home health plan of 

care with either physical therapy or 

speech therapy and skilled nursing 

services are not initially on the plan of 

care. We are proposing to conforming 

regulation text changes at § 484.55(a)(2) 

and (b)(3), respectively to implement 

this provision. 

Currently, the requirement at 

§ 484.55(a)(2) states, ‘‘When 

rehabilitation therapy service (speech 

language pathology, physical therapy, or 

occupational therapy) is the only service 

ordered by the physician or allowed 

practitioner who is responsible for the 

home health plan of care, and if the 

need for that service establishes 

program eligibility, the initial 

assessment visit may be made by the 

appropriate rehabilitation skilled 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35958 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

83Billing for Home Infusion Therapy Services On 

or After January 1, 2021 (MM11880). https://

www.cms.gov/files/document/mm11880.pdf. 84Local Coverage Determination (LCD): External 

Infusion Pumps (L33794). https://www.cms.gov/ 

medicare-coverage-database/details/lcddetails.aspx?LCDId=33794. 85Local Coverage Determination (LCD): External 

Infusion Pumps (L33794). https://www.cms.gov/ 

medicare-coverage-database/details/lcddetails.aspx?LCDId=33794. 

professional.’’ We are proposing to add 

additional language that allows the 

occupational therapist to complete the 

initial assessment for Medicare patients 

when skilled nursing is not initially on 

the plan of care, but occupational 

therapy is ordered with another 

rehabilitation therapy service (speech 

language pathology or physical therapy) 

that establishes program eligibility as a 

need for occupational therapy alone 

would not initially establish program 

eligibility under the Medicare home 

health benefit (see section 1814(a)(2)(c) 

and 1835(a)(2)(A) of the Act). Similarly, 

at § 484.55(b)(3), we are proposing to 

modify our regulatory language to allow 

an occupational therapist to complete 

the comprehensive assessment for 

Medicare patients when ordered with 

another qualifying rehabilitation 

therapy service (speech language 

pathology or physical therapy) that 

establishes program eligibility and when 

skilled nursing is not initially part of the 

plan of care. It should be noted that the 

statutory requirements for establishing 

Medicare program eligibility have not 

changed. Therefore, only the need for 

skilled nursing, physical therapy or 

speech language pathology services can 

initially establish eligibility for 

Medicare home health care. However, 

occupational therapy can maintain 

eligibility for Medicare home health 

care after the need for skilled nursing, 

physical therapy, and speech language 

pathology services have ceased (see 

sections 1814(a)(2)(C) and 1835(a)(2)(A) 

of the Act). 

c. Adequacy of Aide Staffing 

As stated earlier, ensuring that aide 

services are meeting the patient’s needs 

is a critical part in maintaining safe, 

quality care. However, in 2019 MedPAC 

reported that between 1998 and 2017 

home health visits declined by 88 

percent. CMS seeks information about 

the adequacy of aide staffing and 

requests comments on the following: 

• Whether home health agencies 

employ or arrange for (under contract) 

home health aides to provide aide 

services; 

• The number of home health aides 

per home health agency (both directly 

employed and under contract), and 

whether the number has increased or 

decreased over the past 5–10 years; 

• The average number of aide hours 

per beneficiary with aide service 

ordered on the plan of care; 

• The effect of the public health 

emergency on the ability of HHAs to 

employ home health aides or arrange for 

(under contract) the provision of home 

health aide services. 

V. Home Infusion Therapy Services: 

Annual Payment Updates for CY 2022 

A. Home Infusion Therapy Payment 

Categories 

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, 

effective January 1, 2021. 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 

furnished by a qualified home infusion 

therapy supplier. 

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. The 

temporary transitional payment began 

on January 1, 2019 and ended the day 

before the full implementation of the 

home infusion therapy services benefit 

on January 1, 2021. 

For the full implementation of the 

home infusion therapy services benefit 

on January 1, 2021, CMS established a 

unit of single payment for each infusion 

drug administration calendar day in the 

individual’s home. In accordance with 

section 1834(u)(1)(A)(ii) of the Act, a 

unit of single payment must be 

established for different 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 

required that the single payment 

amount reflect factors such as patient 

acuity and complexity of drug 

administration. In the CY 2020 HH PPS 

final rule with comment period (84 FR 

60628), we finalized our proposal to 

maintain the three payment categories 

that were utilized under the temporary 

transitional payments for home infusion 

therapy services. The three payment 

categories group home infusion drugs by 

J-code based on therapy type. The single 

payment amount for each payment 

category varies by utilization of nursing 

services and reflects patient acuity and 

complexity of drug administration, and; 

therefore, ultimately reflects variations 

in infusion drug administration 

services. Payment category 1 comprises 

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 

comprises subcutaneous infusions for 

therapy or prophylaxis, including 

certain subcutaneous immunotherapy 

infusions. Payment category 3 

comprises intravenous chemotherapy 

infusions and other highly complex 

intravenous infusions. We are not 

proposing to make any changes to the 

three payment categories in CY 2022. 

The categories and associated J-codes 

can be found in the MLN Matters article 

entitled ‘‘Billing for Home Infusion 

Therapy Services On or After January 1, 

2021’’ (MM11880).83 This list will be 

updated as new drugs and biologicals 

are added to the DME LCD and 

determined to be ‘‘home infusion 

drugs.’’ The list of home infusion drugs 

and their respective payment categories 

do not need to be updated through 

rulemaking when a new drug is added 

to the DME LCD for External Infusion 

Pumps (L33794).84. The payment 

category may be determined by the DME 

MAC for any subsequent home infusion 

drug additions to the DME LCD for 

External Infusion Pumps (L33794) 85 as 

identified by the following NOC codes: 

J7799 (Not otherwise classified drugs, 

other than inhalation drugs, 

administered through DME) and J7999 

(Compounded drug, not otherwise 

classified). Payment category 1 would 

include any appropriate subsequent 

intravenous infusion drug additions, 

payment category 2 would include any 

appropriate subsequent subcutaneous 

infusion drug additions, and payment 

category 3 would include any 

appropriate subsequent intravenous 

chemotherapy or other highly complex 

drug or biologic infusion additions. 

Section 1861(iii)(3)(C) of the Act 

defines a home infusion drug as a 

parenteral drug or biological 

administered intravenously or 

subcutaneously for an administration 

period of 15 minutes or more, in the 

home of an individual through a pump 

that is an item of DME. Such term does 

not include the following: (1) Insulin 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35959 

86Home Infusion Therapy Services Billing and 

Rates. https://www.cms.gov/medicare/homeinfusion-therapy-services/billing-and-rates. 

pump systems; and (2) a selfadministered drug or biological on a 

self-administered drug (SAD) exclusion 

list. Division CC, section 117 of CAA 

2021 amended section 1861(iii)(3)(C) of 

the Act so that the previously detailed 

SAD exclusion in the definition of home 

infusion drug would not apply to a selfadministered drug or biological on a 

SAD exclusion list if such drug or 

biological was included as a transitional 

home infusion drug under subparagraph 

(A)(iii) of section 1834(u)(7), and was 

identified by a HCPCS code described in 

subparagraph (C)(ii) of such section. 

In the CY 2021 HH PPS final rule (85 

FR 70337), we stated that Hizentra®, a 

subcutaneous immunoglobulin, was not 

included in the definition of ‘‘home 

infusion drugs’’ under the benefit 

beginning January 1, 2021, because it 

was listed on a SAD exclusion list 

maintained by the Medicare 

Administrative Contractors (MACs). We 

also stated that if it is removed from all 

the SAD exclusion lists, Hizentra®

could be added to the home infusion 

drugs list in the future. After 

publication of the CY 2021 HH PPS 

Final Rule on November 4, 2020, CAA 

2021 was signed into law on December 

27, 2020. Division CC, section 117 of 

CAA 2021 amended the definition of 

home infusion drugs in Section 

1861(iii)(3)(C) of the Act as previously 

noted. 

Hizentra® was included as a 

transitional home infusion drug 

according to the definition of such drug 

in section 1834(u)(7)(A)(iii) of the Act, 

and was identified by a HCPCS code 

(J1559) described in subparagraph (C)(ii) 

of such section of the Act. Therefore, 

consistent with the statutorily amended 

definition of ‘‘home infusion drug’’, the 

home infusion therapy services related 

to the administration of Hizentra® are 

covered under payment category 2 

under both the temporary transitional 

payment from 2019 to 2020, and the 

permanent benefit beginning January 1, 

2021. 

It is important to note that the list of 

home infusion drugs is maintained by 

the DME MACs, and the drugs or their 

respective payment categories for 

purposes of the home infusion therapy 

services benefit do not need to be 

updated through rulemaking every time 

a new drug is added to the DME LCD 

for External Infusion Pumps (L33794). 

For these routine updates, CMS will 

implement such changes through the 

subregulatory change request process. 

B. Payment Adjustments for CY 2022 

Home Infusion Therapy Services 

1. 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 CY 2020 HH PPS final 

rule with comment period (84 FR 

60629) we finalized the use of the 

geographic adjustment factor (GAF) to 

adjust home infusion therapy payments 

for differences in geographic area wages 

rates based on the location of the 

beneficiary. We remind stakeholders 

that the GAFs are a weighted composite 

of each Physician Fee Schedule (PFS) 

localities work, practice expense (PE) 

and malpractice (MP) expense 

geographic practice cost indices (GPCIs) 

using the national GPCI cost share 

weights. The periodic review and 

adjustment of GPCIs is mandated by 

section 1848(e)(1)(C) of the Act. At each 

update, the proposed GPCIs are 

published in the PFS proposed rule to 

provide an opportunity for public 

comment and further revisions in 

response to comments prior to 

implementation. The GPCIs and the 

GAFs are updated triennially with a 2- 

year phase in and were last updated in 

the CY 2020 PFS final rule. The next 

full update to the GPCIs and the GAFs 

will be in the CY 2023 PFS proposed 

rule. For CY 2022, there will be changes 

to the GAF values for the majority of 

localities located in California because 

CY 2022 is the last year of a 5-year 

incremental transition for the majority 

of the California localities implemented 

in 2017 in accordance with the 

Protecting Access to Medicare Act of 

2014 (PAMA 2014). The CY 2022 PFS 

proposed GAFs will be available on the 

PFS website at https://www.cms.gov/ 

Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched. 

In the CY 2020 HH PPS final rule with 

comment period (84 FR 60629) we 

stated that the application of the GAF 

would be budget neutral so there is no 

overall cost impact by applying a 

budget-neutrality factor. We propose to 

continue this practice and apply the 

GAF budget-neutrality factor to the 

home infusion therapy service payment 

rates whenever there are changes to the 

GAFs in order to eliminate the aggregate 

effect of variations in the GAFs. For CY 

2022, the GAF standardization factor 

would equal the ratio of the estimated 

national spending total using the CY 

2021 GAF to the estimated national 

spending total using the CY 2022 GAF. 

Estimates of national spending totals 

would use home infusion therapy 

benefit utilization data for CY 2020. The 

CY 2022 GAF was not available in time 

for this proposed rule. We will calculate 

the CY 2022 GAF standardization factor 

that will be used in updating the 

payment amounts for CY 2022 and we 

will include this information in a 

forthcoming change request that would 

be issued to implement the CY 2022 

home infusion therapy services payment 

amounts. The CY 2022 GAF values will 

be posted as an addendum on the PFS 

website at: https://www.cms.gov/ 

Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched under the 

supporting documentation section of the 

CY 2022 Medicare Physician Fee 

Schedule Final Rule and posted on the 

Home Infusion Therapy Billing and 

Rates web page.86

2. Consumer Price Index 

Subparagraphs (A) and (B) of section 

1834(u)(3) of the Act specify annual 

adjustments to the single payment 

amount that are required to be made 

beginning January 1, 2022. In 

accordance with these sections we are 

required to increase the single payment 

amount from the prior year (that is, CY 

2021) by the percentage increase in the 

CPI–U for the 12-month period ending 

with June of the preceding year, reduced 

by a productivity adjustment described 

in section 1886(b)(3)(B)(xi)(II) of the Act 

as the 10-year moving average of 

changes in annual economy-wide 

private nonfarm business multifactor 

productivity. Section 1834(u)(3) of the 

Act further states that the application of 

the productivity adjustment 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. 

The CPI–U for the 12-month period 

ending with June of the preceding year 

is not available at the time of this 

proposed rulemaking. The CPI–U for the 

12-month period ending in June of 2021 

and the corresponding productivity 

adjustment will be updated in the final 

rule. 

3. Initial and Subsequent Visit 

Adjustment 

In the CY 2020 HH PPS final rule with 

comment period (84 FR 60627), we 

finalized our policy that 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 will be increased by the 

average difference between the PFS 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35960 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

87Medicare Learning Network Connects ‘‘Special 

Edition: Physician Fee Schedule Update’’ (Jan 7, 

2021). https://www.cms.gov/files/document/2021- 

01-07-mlnc-se.pdf. 

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. We remind 

stakeholders that effective January 1, 

2021 there were changes to the office/ 

outpatient E/M visit code set (CPT codes 

99201 through 99215) used to calculate 

the initial and subsequent visit payment 

amounts for home infusion therapy. 

These changes were adopted from the 

new coding, prefatory language, and 

interpretive guidance framework that 

has been issued by the AMA’s CPT 

Editorial Panel (see https://www.amaassn.org/practice-management/cpt/cptevaluation-and-management) and 

include the deletion of code 99201 

(Level 1 office/outpatient visit, new 

patient), and new values for CPT codes 

99202 through 99215. The initial visit 

percentage increase will still be 

calculated using the average difference 

between the PFS amounts for E/M 

existing patient visits and new patient 

visits for a given year; however, only 

new patient E/M codes 99202 through 

99205 were used in the calculation, as 

the final policy indicates that the 

calculation is based on the relative 

difference between the average of the 

new and existing patient E/M codes. For 

CY 2021, the initial visit percentage 

increase was calculated using the 

average difference between the CY 2021 

PFS amounts for office/outpatient E/M 

existing patient visits (99211 through 

99215) and the CY 2021 PFS amounts 

for office/outpatient E/M new patient 

visits (99202 through 99205). In the CY 

2021 HH PPS final rule (85 FR 70340), 

we estimated a 19 percent increase in 

the first visit payment amount and a 

1.18 percent decrease in subsequent 

visit amounts based on the average 

difference between the CY 2021 

proposed PFS E/M codes amounts for 

new and existing patients. The percent 

increase remained 19 percent for the 

first visit payment amount and the 

percent decrease remained 1.18 percent 

for subsequent visit amounts using the 

final PFS E/M rates for new and existing 

patients. 

However, Division N, section 101 of 

CAA 2021 added section 1848(t)(1) of 

the Act, which applied a 3.75 percent 

increase in PFS payment amounts only 

for CY 2021.87 Division CC, section 113 

of CAA 2021 also delayed the 

implementation of an add-on E/M code 

G2211 until CY 2024. Because the PFS 

relative value units (RVUs) are budget 

neutral, this delay in the 

implementation of the add-on code 

changed the RVUs for all codes under 

the PFS, including the E/M codes used 

to calculate the home infusion therapy 

service payment initial visit percent 

increase. The updated RVUs and 

conversion factor after the changes 

implemented by the CAA 2021 were 

used to recalculate the CY 2021 

payment amounts for home infusion 

therapy services, and the percent 

difference used to calculate the initial 

visit percentage increase. As a result, 

the initial home infusion therapy 

service visits increase was updated to 20 

percent and the decrease for subsequent 

visits was updated to 1.3310. We note 

that the change in the percent increase 

for initial visits was driven by the delay 

of the code G2211. While the updated 

payment amounts (after the changes 

implemented by the CAA 2021) for the 

office/outpatient E/M codes were used 

to recalculate the initial visit increase, 

removing the 3.75 percent does not 

impact the average difference between 

the office/outpatient E/M codes for new 

patient visits and existing patient 

because the increase was applied 

equally. Therefore, after removing the 

adjustment, the percent increase 

remains 20 percent for the initial visit 

payment amounts and a 1.3310 percent 

decrease for all subsequent visit 

payment amounts. 

In the CY 2021 final rule (85 FR 

70298, 70339) we also stated that we 

would 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. 

Section 1834 (u)(3) of the Act requires 

the rates from the previous year to be 

updated by the percentage increase in 

the CPI–U for the 12-month period 

ending in June of 2021 reduced by a 

productivity adjustment beginning in 

2022. Therefore, CMS is to update the 

established payment rates for CY 2021 

by the percentage increase in the CPI– 

U reduced by the productivity 

adjustment without recalculating the 

percent difference each year using the 

updated values for the PFS E/M codes 

for CY 2022 payment purposes. For CY 

2022, we are proposing to maintain the 

20 percent increase calculated for the 

initial home infusion therapy service 

visits and the 1.3310 percent decrease 

calculated for subsequent visits after 

implementation of the changes 

mandated by the CAA 2021, which we 

previously noted did not impact these 

percentages. Table 34 shows the 

updated E/M visit codes and the final 

unadjusted PFS payment amounts 

(without the 3.75 percent increase 

implemented by the CAA 2021) for CY 

2021, for both new and existing 

patients, used to determine the 

increased payment amount for the first 

visit. We invite comments on our 

proposal to maintain the percentages 

calculated for initial and subsequent 

home infusion therapy service visits 

calculated after implementing the 

changes mandated by the CAA 2021. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35961 

88Medicare Learning Network Connects ‘‘Special 

Edition: Physician Fee Schedule Update’’ (Jan 7, 

2021). https://www.cms.gov/files/document/2021- 

01-07-mlnc-se.pdf. 

89Home Infusion Therapy Services Billing and 

Rates. https://www.cms.gov/medicare/homeinfusion-therapy-services/billing-and-rates. 

C. CY 2022 Payment Amounts for Home 

Infusion Therapy Services 

As noted previously, Division N, 

section 101 of CAA 2021 amended 

added section 1848(t)(1) of the Act, 

which applied and modified the CY 

2021 PFS rates by providing a 3.75 

percent increase in PFS payment 

amounts only for CY 2021.88 For CY 

2022, CMS will remove the 3.75 percent 

increase from the PFS amounts used to 

establish the CY 2021 home infusion 

therapy payment rates and use the 

unadjusted CY 2021 rates for these CY 

2022 payment amounts will be updated 

for CY 2022 in accordance with section 

1834(u)(3) of the Act using the 

percentage increase in the CPI–U for the 

12-month period ending in June of 2021 

reduced by the productivity adjustment, 

adjusted for MFP. 

The final home infusion therapy 5- 

hour payment amounts will be released 

in a forthcoming change request CR and 

posted on the Home Infusion Therapy 

Billing and Rates web page.89 For more 

in-depth information regarding the 

finalized policies associated with the 

scope of the home infusion therapy 

services benefit and conditions for 

payment, we refer readers to the CY 

2020 HH PPS final rule with comment 

period (84 FR 60544). 

VI. Medicare Provider and Supplier 

Enrollment Changes 

A. Background—Provider and Supplier 

Enrollment Process 

1. General Discussion 

Section 1866(j)(1)(A) of the Act 

requires the Secretary to establish a 

process for the enrollment of providers 

and suppliers in the Medicare program. 

The overarching purpose of the 

enrollment process is to help confirm 

that providers and suppliers seeking to 

bill Medicare for services and items 

furnished to Medicare beneficiaries 

meet Federal and State requirements to 

do so. The process is, to an extent, a 

‘‘gatekeeper’’ that helps prevent 

unqualified and potentially fraudulent 

individuals and entities from being able 

to enter and inappropriately bill 

Medicare. Since 2006, we have taken 

various steps via rulemaking to outline 

our enrollment procedures. These 

regulations are generally incorporated in 

42 CFR part 424, subpart P (currently 

§§ 424.500 through 424.570 and 

hereafter occasionally referenced as 

subpart P). They address, among other 

things, requirements that providers and 

suppliers must meet to obtain and 

maintain Medicare billing privileges. 

One such requirement (outlined in 

§ 424.510) is that the provider or 

supplier must complete, sign, and 

submit to its assigned Medicare 

Administrative Contractor (MAC) 

(hereafter occasionally referenced as 

‘‘Medicare contractor’’ or simply 

‘‘contractor’’) the appropriate 

enrollment application, typically the 

Form CMS–855 (OMB Control No. 

0938–0685). The Form CMS–855, which 

can be submitted via paper or 

electronically through the internetbased Provider Enrollment, Chain, and 

Ownership System (PECOS) process 

(SORN: 09–70–0532, Provider 

Enrollment, Chain, and Ownership 

System) collects important information 

about the provider or supplier; such 

data includes, but is not limited to, 

general identifying information (for 

example, legal business name), 

licensure and/or certification data, and 

practice locations. After receiving the 

provider’s or supplier’s initial 

enrollment application, CMS or the 

MAC will review and confirm the 

information thereon and determine 

whether the provider or supplier meets 

all applicable Medicare requirements. 

We believe this screening process has 

greatly assisted CMS in executing its 

responsibility to prevent Medicare 

fraud, waste, and abuse. 

As already mentioned, over the years 

we have issued various final rules 

pertaining to provider and supplier 

enrollment. 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. Consistent therewith, and as 

further discussed in section VI.B. of this 

proposed rule, we propose several 

changes to our existing provider 

enrollment regulations in this proposed 

rule. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.053</GPH>

TABLE 34: AVERAGE PERCENT DIFFERENCE BETWEEN PFS E/M CODES FOR 

NEWAND EXISTING PATIENTS 

99211 $22.20 NA 

99202 $71.30 99212 $54.82 30% 

99203 $109.64 99213 $89.12 23% 

99204 $163.79 99214 $126.46 30% 

99205 $216.25 99215 $176.57 22% 

Total $560.98 $469.17 20% 

Source: The unadjusted CY 2021 PFS rates are calculated based on the updated CY 2021 RVUs which were 

recalculated after the removal of code G2211 and the unadjusted PFS Conversion Factor which is calculated by 

removing the 3.75 percent increase in PFS payments for CY 2021. The RVUs used in CY 2021 Final Rule are taken 

from CY 2021 PFS Final Rule Addendum B, version dated December 29, 2020 (Available at: 

https:/ /www.cms.gov/files/zip/cy-2021-pfs-final-rule-addenda-updated-12292020 .zip; Accessed on 3/17/2021). 
35962 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

2. Legal Authorities 

There are two principal sources of 

legal authority for our proposed 

provider enrollment provisions. Section 

1866(j) of the Act provides specific 

authority with respect to the enrollment 

process for providers and suppliers. 

Sections 1102 and 1871 of the Act 

furnish general authority for the 

Secretary to prescribe regulations for the 

efficient administration of the Medicare 

program. 

B. Proposed Provisions 

1. Effective Dates 

We propose to codify in regulation 

certain effective date practices 

discussed in CMS Publication 100–08, 

Program Integrity Manual (PIM) (or in 

other subregulatory guidance). We 

believe that incorporating these topics 

into 42 CFR part 424 would furnish 

needed clarification and allow the 

provider community to furnish public 

comments thereon. 

a. Effective Date of Billing Privileges 

Section 424.520 outlines the effective 

date of billing privileges for provider 

and supplier types that are eligible to 

enroll in Medicare. Paragraph (d) 

thereof sets forth the applicable effective 

date for physicians, non-physician 

practitioners (NPP), physician 

organizations, NPP organizations, 

ambulance suppliers, opioid treatment 

programs, and home infusion therapy 

suppliers. This effective date is the later 

of: (1) The date of filing of a Medicare 

enrollment application that a Medicare 

contractor subsequently approved; or (2) 

the date that the provider or supplier 

first began furnishing services at a new 

practice location. In a similar vein, 

§ 424.521(a) States that the seven 

previously mentioned provider and 

supplier types can retrospectively bill 

for services when they have 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 

(Pub. L. 100–707, enacted November 23, 

1988), 42 U.S.C. 5121–5206 (Stafford 

Act), precluded enrollment in advance 

of providing services to Medicare 

beneficiaries. 

In essence, these provisions afford the 

affected providers and suppliers a 

limited ability to ‘‘back bill’’ for services 

furnished before the contractor approves 

the provider’s or supplier’s application. 

This reflects CMS’ recognition that 

circumstances can prevent a provider’s 

or supplier’s enrollment prior to the 

furnishing of Medicare services. With 

this in mind, CMS, under the applicable 

PIM guidance, had applied the effective 

date policies in §§ 424.520(d) and 

424.521(a) to the following additional 

supplier types: (1) Part B hospital 

departments; (2) Clinical Laboratory 

Improvement Amendment labs; (3) 

intensive cardiac rehabilitation 

facilities; (4) mammography centers; (5) 

mass immunizers/pharmacies; (6) 

radiation therapy centers; (7) physical 

therapists; (8) occupational therapists; 

and (9) speech language pathologists. 

For the reasons previously discussed, 

we propose to add these nine supplier 

types to the scope of §§ 424.520(d) and 

424.521(a). The specific regulatory 

changes would be as follows. 

First, the title and opening paragraph 

of § 424.520(d) currently reads: (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 nonphysician practitioner organizations, 

ambulance suppliers, opioid treatment 

programs, and home infusion therapy 

suppliers is the later of . . . . Rather 

than add the nine aforementioned 

supplier types to the seven provider and 

supplier types already listed within this 

language (thus making the latter 

unnecessarily long), we propose to 

shorten and simplify the language to 

state that the effective date of billing 

privileges for the provider and supplier 

types identified in paragraph (d)(2) of 

this section is the later of the following. 

Consistent with this proposed change, 

we would also do the following: 

• Redesignate existing § 424.520(d)(1) 

and (2) as, respectively, new 

§ 424.520(d)(1)(i) and (ii). 

• List the 16 previously referenced 

provider and supplier types as new 

§ 424.520(d)(2)(i) through (xvi). 

Second, the title of § 424.521 would 

be changed from ‘‘Request for payment 

by physicians, non-physician 

practitioners, physician and nonphysician organizations, ambulance 

suppliers, opioid treatment programs, 

and home infusion therapy suppliers’’ 

to ‘‘Request for payment by certain 

provider and supplier types.’’ 

Third, the opening language of 

current § 424.521(a) reads ‘‘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—.’’ We 

propose to revise this language to state 

that the providers and suppliers 

identified in paragraph (a)(2) of this 

section may retrospectively bill for 

services when the provider or supplier. 

Fourth, we propose to— 

• Redesignate existing § 424.521(a)(1) 

and (2) as, respectively, new 

§ 424.521(a)(1)(i) and (ii); and 

• List the 16 aforementioned provider 

and supplier types as new 

§ 424.521(a)(2)(i) through (xvi). 

b. Effective Dates of Reassignments and 

Form CMS–855O Enrollments 

(1) Reassignments 

A Form CMS–855R application (OMB 

Control No. 0938–0685) must be 

completed for any individual supplier 

(reassignor) who wishes to reassign his 

or her Part B benefits to an eligible 

entity or individual (reassignee) under 

§ 424.80. (This frequently occurs when, 

for example, a physician joins a group 

practice and, as a condition of her 

employment, reassigns the payments for 

the services she furnishes on behalf of 

the group practice to the latter.) If the 

reassignor is not enrolled in Medicare, 

he or she must complete a Form CMS– 

855I (OMB Control No. 0938–0685) 

application as well as a Form CMS– 

855R. 

Under the applicable PIM guidance, 

CMS applied the basic principles of 

§§ 424.520(d) and 424.521(a) to Form 

CMS–855R reassignments when 

establishing the effective date of the 

latter. As with §§ 424.520(d) and 

424.521(a), this subregulatory policy 

was intended to account for instances 

where the supplier may have been 

unable to submit a Form CMS–855R 

application earlier than what occurred. 

To codify this into regulation, we 

propose to add a new § 424.522, the title 

of which would state: ‘‘Additional 

effective dates.’’ Paragraph (a) of 

§ 424.522 would specify that a 

reassignment of benefits under § 424.80 

is effective beginning 30 days before the 

Form CMS–855R is submitted if all 

applicable requirements during that 

period were otherwise met. 

(2) Practitioner Enrolling Solely To 

Order or Certify Via Form CMS–855O 

Under § 424.507, a physician or other 

eligible professional (as that term is 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35963 

defined in § 424.506(a)) who orders or 

certifies covered—(1) Imaging services; 

(2) clinical laboratory services; (3) 

durable medical equipment, prosthetics, 

orthotics, and supplies; and/or (4) home 

health services must be enrolled in or 

validly opted-out of Medicare for the 

resulting claim to be eligible for 

payment. There are situations where the 

physician or other eligible professional 

indeed wishes to enroll to order and/or 

certify these services and/or items but is 

not seeking Medicare billing privileges. 

He or she will accordingly complete the 

Form CMS–855O (‘‘Medicare 

Enrollment Application: Enrollment for 

Eligible Ordering, Certifying and 

Prescribing Physicians and Eligible 

Professionals; OMB Control #: 0935– 

1135). CMS or MAC approval of this 

application does not grant billing 

privileges but only permits the 

individual to order/certify the 

aforementioned services and/or items. 

Although the effective date provisions 

in §§ 424.520(d) and 424.521(a) do not 

(and indeed could not) apply to Form 

CMS–855O enrollments because no 

billing privileges or payments are 

involved, the PIM states that a Form 

CMS–855O enrollment effective date is 

the date on which the Medicare 

contractor received the application (as 

opposed to, for instance, the date the 

contractor approves the application). 

This permitted the individual to order/ 

certify these services and items for a 

limited period prior to enrollment. To 

codify this in regulation, we propose to 

state the following in new § 424.522(b): 

‘‘The effective date of a Form CMS– 

855O enrollment is the date on which 

the Medicare contractor received the 

Form CMS–855O application if all other 

requirements are met.’’ 

We are also proposing several 

effective date provisions relating to the 

provider enrollment concept of 

deactivation. These are addressed 

within the larger deactivation 

discussion in section VI.B.3. of this 

proposed rule. 

2. Rejections and Returns 

a. Background and Distinction 

Per § 424.525(a), CMS may reject a 

provider’s or supplier’s enrollment 

application for any of the following 

reasons: 

• The prospective provider or 

supplier fails to furnish complete 

information on the provider/supplier 

enrollment application within 30 

calendar days from the date of the 

Medicare contractor’s request for the 

missing information. 

• The prospective provider or 

supplier fails to furnish all required 

supporting documentation within 30 

calendar days of submitting the 

enrollment application. 

• The prospective institutional 

provider (as defined in § 424.502) does 

not submit the application fee (in 

accordance with § 424.514) in the 

designated amount or a hardship waiver 

request with the Medicare enrollment 

application at the time of filing. 

The PIM outlines additional factual 

situations in which an application could 

have been rejected. 

The purpose of the rejection policy is 

to encourage the provider or supplier to: 

(1) Fully and completely submit all 

required information (and any required 

documentation) with their enrollment 

application; and (2) promptly respond 

to any contractor requests for 

clarification regarding the application. If 

a provider’s or supplier’s application is 

rejected (for example, because the 

provider or supplier did not correct an 

error on its application per the 

contractor’s request), the contractor 

notifies the provider or supplier via 

letter accordingly. The letter outlines, 

among other things, the reason for the 

rejection under § 424.525(a) and informs 

the provider or supplier that the latter 

must submit a new application. 

The PIM also discusses the return of 

provider enrollment applications. In 

general, an application has been 

returned when one of the return 

grounds outlined in the PIM applied. 

These grounds typically involve 

situations where the provider’s or 

supplier’s submission constitutes, in 

essence, a non-application. This is 

different from a rejected application in 

that the latter: (1) Does not 

automatically involve an invalid 

submission yet the application, for 

instance, failed to include certain 

information or documentation or 

contains erroneous data; and (2) can be 

remedied prior to any rejection via the 

provider’s or supplier’s submission of a 

corrected, revised, supplemented, or 

complete application. 

We recognize that there has been 

uncertainty within the provider 

community regarding the difference 

between application rejections and 

returns as well as the grounds for both 

actions. To clarify these issues, we 

propose to revise § 424.525 and to add 

a new § 424.526. 

b. Proposed Rejection and Return 

Policies 

(1) Rejections 

The three previously mentioned 

reasons in § 424.525(a) for rejecting an 

application are currently designated as, 

respectively, paragraphs (a)(1), (a)(2), 

and (a)(3). We propose to include the 

following ten rejection scenarios (almost 

all of which had been identified as 

reasons for rejection in the PIM) within 

the larger § 424.525(a)(1) category. This 

means that rejection in these ten 

situations would only occur if the 

provider or supplier failed to comply 

with the requirements of (a)(1) (for 

instance, furnishing correct and 

complete data) within the 30-day period 

stated therein. We believe that 

incorporating these situations within 

the scope of § 424.525(a)(1) would ease 

the burden on providers and suppliers 

because they would be given time to 

correct the application’s deficiencies. 

(We note that, under the current and 

proposed versions of § 424.525, CMS 

may reject an application but is not 

required to.) 

The scenarios in question would be 

designated as § 424.525(a)(1)(i) through 

(x) and are as follows: 

• The application is missing data 

required by CMS or the Medicare 

contractor to process the application 

(such as, but not limited to, names, 

social security number, contact 

information, and practice location 

information). 

• The application is unsigned or 

undated. 

• The application contains a copied 

or stamped signature. 

• The application is signed more than 

120 days prior to the date on which the 

Medicare contractor received the 

application. 

• The application is signed by a 

person unauthorized to do so under 42 

CFR part 424, subpart P. 

• For paper applications, the required 

certification statement is missing. 

• The paper application is completed 

in pencil. 

• The application is submitted via fax 

or email when the provider or supplier 

was not otherwise permitted to do so. 

• The provider or supplier failed to 

submit all of the forms needed to 

process a Form CMS–855 reassignment 

package within 30 days of receipt. (For 

example, a newly enrolling physician 

who will be reassigning her benefits to 

a group practice submits a Form CMS– 

855R application but fails to submit an 

accompanying Form CMS–855I 

application.) 

• The provider or supplier submitted 

the incorrect Form CMS–855 

application. (For example, the provider 

submitted a Form CMS–855B when a 

Form CMS–855A application (Medicare 

Enrollment Application; Institutional 

Providers; OMB # 0938–0685) was 

required.) 

We reiterate our belief, and it has 

been our experience, that these rejection 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35964 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

scenarios in proposed new 

§ 424.525(a)(1)(i) through (x) involve 

situations where the provider or 

supplier can remedy (and, in many 

cases, has remedied) their application 

submission fairly expeditiously. (For 

instance, an unsigned or improperly 

signed application can be corrected with 

the proper signature.) Grounds for 

application returns, on the other hand, 

involve situations that cannot be 

remedied without an entirely new 

application submission because the 

initial submission was invalid or 

otherwise could not be accepted and 

processed. With both rejections and 

returns, however, there are no appeal 

rights. 

Existing § 424.525(b), (c), and (d) 

address various operational aspects of 

our rejection policy. We are not 

proposing to revise them. However, and 

to clarify the scope of § 424.525, we 

propose in new § 424.525(e) that 

§ 424.525 applies to all CMS provider 

enrollment application submissions, 

including: (1) Form CMS–855 initial 

applications, change of information 

requests, changes of ownership 

(CHOWs), revalidations, and 

reactivations; (2) Form CMS–588 

(Electronic Funds Transfer (EFT) 

Authorization Agreement; OMB # 0938– 

0626) submissions; (3) Form CMS– 

20134 submissions; and (4) any 

electronic or successor versions of the 

forms identified in § 424.525(e)(1) 

through (3). This is to help ensure that 

the provider or supplier furnishes a 

correct and complete submission 

regardless of the type of CMS 

enrollment form involved. Concomitant 

with this change, we propose to remove 

the word ‘‘prospective’’ from 

§§ 424.525(a)(1), (a)(2), (a)(3), and (b). 

This will clarify that these three 

rejection grounds apply to enrolled 

providers and suppliers and not simply 

prospective enrollees. 

(1) Returns 

For reasons already explained, we 

propose in new § 424.526(a) that the 

following situations constitute grounds 

for CMS’ or the contractor’s return of the 

provider’s or supplier’s application to 

the provider or supplier. These grounds, 

which were discussed in the PIM, 

would be designated as § 424.526(a)(1) 

through (13). The opening language of 

paragraph (a) would state, however, that 

CMS or the Medicare contractor ‘‘may’’ 

return the application in the following 

instances but is not required to: 

• The provider or supplier sent its 

paper Form CMS–855, Form CMS–588, 

or Form CMS–20134 application to the 

incorrect Medicare contractor for 

processing. (For example, the 

application was sent to Contractor X 

instead of Contractor Y.) 

• The Medicare contractor received 

the application more than 60 days prior 

to the effective date listed on the 

application. (This does not apply to (1) 

providers and suppliers submitting a 

Form CMS–855A application, (2) 

ambulatory surgical centers, or (3) 

portable x-ray suppliers. 

• The seller or buyer in a change of 

ownership submitted its Form CMS– 

855A or Form CMS–855B application 

more than 90 days prior to the 

anticipated date of the sale. 

• The Medicare contractor received 

an initial application more than 180 

days prior to the effective date listed on 

the application from (1) a provider or 

supplier submitting a Form CMS–855A 

application, (2) an ambulatory surgical 

center, or (3) a portable x-ray supplier. 

• The Medicare contractor confirms 

that the provider or supplier submitted 

an initial enrollment application prior 

to the expiration of the time period in 

which it is entitled to appeal the denial 

of its previously submitted application. 

• The provider or supplier submitted 

an initial enrollment application prior 

to the expiration of their existing 

reenrollment bar under § 424.535 or 

reapplication bar under § 424.530(f). 

• The application is not needed for 

(or is inapplicable to) the transaction in 

question. 

• The provider or supplier submitted 

a revalidation application more than 7 

months prior to the provider’s or 

supplier’s revalidation due date. 

• A Medicare Diabetes Prevention 

Program (MDPP) supplier submitted an 

application with a coach start date more 

than 30 days in the future. (That is, the 

application lists an MDPP coach who 

will commence his or her services 

beginning at least 31 days after the date 

the Medicare contractor receives the 

application.) 

• The provider or supplier requests 

that their application be withdrawn 

prior to or during the Medicare 

contractor’s processing thereof. 

• The provider or supplier submits an 

application that is an exact duplicate of 

an application that (1) has already been 

processed or (2) is currently being 

processed or is pending processing. 

• The provider or supplier submits a 

paper Form CMS–855 or Form CMS– 

20134 application that is outdated and/ 

or has been superseded by a revised 

version. 

• The provider or supplier submits a 

Form CMS–855A or Form CMS–855B 

initial enrollment application followed 

by a Form CMS–855A or Form CMS– 

855B CHOW application. If the 

Medicare contractor: 

++ Has not yet made a 

recommendation for approval 

concerning the initial application, both 

applications may be returned in this 

scenario. 

++ Has made a recommendation for 

approval concerning the initial 

application, the Medicare contractor 

may return the CHOW application. If, 

per the Medicare contractor’s written 

request, the provider or supplier fails to 

submit a new initial Form CMS–855A or 

Form CMS–855B application containing 

the new owner’s information within 30 

days of the date of the letter, the 

Medicare contractor may return the 

originally submitted initial Form CMS– 

855A or Form CMS–855B application. 

We note that several of these return 

grounds involve situations where the 

application is submitted prematurely. 

CMS and its contractors had previously 

encountered numerous instances where, 

for instance, a Part B supplier would 

submit an enrollment application well 

over 9 months before: (1) The practice 

location effective date that the supplier 

listed on their application; and/or (2) 

the date on which the supplier planned 

to begin furnishing services or otherwise 

commence operations. Just as 

frequently, providers and suppliers 

would submit initial enrollment 

applications well in advance of the 

expiration of their: (1) Appeal rights 

following the denial of their previous 

application submission; and/or (2) 

Medicare reenrollment bar following a 

revocation. This essentially required 

contractors to hold and track the 

submitted application for many months 

until the application could be processed 

at a time closer to the supplier’s 

commencement date. To alleviate 

contractors of this burden, the PIM 

identified various dates before which 

the provider or supplier could not 

submit an application. 

We also propose in § 424.526 to 

explain certain operational components 

of our return policy. First, we propose 

in § 424.526(b) that a provider or 

supplier may not appeal a return of their 

enrollment application. (Section 

424.525(d) contains a similar provision 

for rejections.) Since, as previously 

stated, we believe the situations 

outlined in proposed § 424.526(a) 

essentially involve the submission of a 

non-application, we do not believe 

appeal rights would be appropriate. 

Second, we propose to effectively 

duplicate proposed § 424.525(e) in new 

proposed § 424.526(c). This would 

clarify the types of enrollment 

applications and transactions to which 

§ 424.526 would apply. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35965 

3. Deactivation 

(a) Background 

Regulatory policies regarding the 

provider enrollment concept of 

deactivation are addressed in § 424.540. 

Deactivation means that the provider’s 

or supplier’s billing privileges are 

stopped but can be restored (or 

‘‘reactivated’’) upon the submission of 

information required under § 424.540. 

As stated in § 424.540(c), deactivation is 

intended to protect the provider or 

supplier from the misuse of its billing 

number and to protect the Medicare 

Trust Funds from unnecessary 

overpayments. 

A deactivated provider or supplier is 

not revoked from Medicare and remains 

enrolled in the program; also, per 

§ 424.540(c), deactivation does not 

impact the provider’s or supplier’s 

existing provider or supplier agreement. 

However, the provider’s or supplier’s 

ability to bill Medicare is halted 

pending its compliance with § 424.540’s 

requirements for reactivation. 

Deactivation, in short, is a less severe 

action than a revocation but one 

significant enough to encourage 

providers and suppliers to maintain 

compliance with enrollment 

requirements. 

There are currently three grounds for 

deactivation under § 424.540(a), listed 

as, respectively, paragraphs (a)(1), (a)(2), 

and (a)(3): 

• The provider or supplier does not 

submit any Medicare claims for 12 

consecutive calendar months. 

• The provider or supplier does not 

report a change in its enrollment 

information within 90 calendar days of 

the change. (Changes in ownership or 

control must be reported within 30 

calendar days.) 

• The provider or supplier does not 

furnish complete and accurate 

information and all supporting 

documentation within 90 calendar days 

of receipt of notification from CMS to 

submit a revalidation application in 

accordance with § 424.515. (In addition, 

§ 424.550(b) permits deactivation if the 

prospective new owner in a CHOW fails 

to submit a new enrollment application 

containing information concerning the 

new owner within 30 days of the 

CHOW. CMS may also deactivate in a 

CHOW situation if: (1) An incomplete 

CHOW application is submitted 

containing material omissions; or (2) 

CMS has information that makes it 

question whether the provider 

agreement will be transferred to the new 

owner.) 

To reactivate one’s billing privileges, 

§ 424.540(b) states that the provider or 

supplier must: (1) Recertify that their 

enrollment information currently on file 

with Medicare is correct and furnish 

any missing information as appropriate; 

or (2) submit a complete Form CMS–855 

application if required by CMS. 

We constantly examine the 

effectiveness of our deactivation 

processes from both a program integrity 

and a provider impact perspective. 

Based on this monitoring, we believe 

that several revisions to § 424.540 are 

needed. In general, these changes are 

meant to, as applicable: (1) Clarify 

existing policies; (2) incorporate certain 

subregulatory discussions into § 424.540 

to afford stakeholders an opportunity for 

public comment; (3) give CMS greater 

flexibility in its payment safeguard 

activities; and (4) reduce provider and 

supplier burden. 

(b) Grounds for Deactivation 

As already mentioned, deactivation is 

a CMS action that is more moderate 

than a revocation. Unlike the latter, a 

deactivation neither involves the 

imposition of a reenrollment bar nor is 

considered a final adverse action under 

§ 424.502. It constitutes, in a sense, a 

middle ground between CMS imposing 

a revocation that (under the 

circumstances) could be an overly harsh 

measure and CMS taking no action at 

all, thus potentially leaving a program 

integrity risk intact. In this manner, it 

enables us to avoid an ‘‘all-or-nothing’’ 

situation. 

We believe that expanding this 

flexibility to include additional grounds 

for deactivation would help CMS 

achieve a proper medium that protects 

the Medicare program without 

burdening providers and suppliers with 

an unwarranted revocation and the 

consequences thereof. It would, at CMS’ 

discretion, allow for a third option 

(besides revocation and non-action) that 

might be the fairest and most 

appropriate given the facts involved. 

Accordingly, we propose a number of 

changes to § 424.540(a) and (b). 

First, existing paragraph (a) contains 

an opening clause followed by the three 

existing deactivation reasons, codified 

as paragraphs (a)(1), (a)(2), and (a)(3). 

We propose to add several new 

deactivation grounds as paragraphs 

(a)(4) through (a)(8); respectively, they 

would be as follows: 

• The provider or supplier is not in 

compliance with all enrollment 

requirements in Title 42. 

• The provider’s or supplier’s 

practice location is non-operational or 

otherwise invalid. 

• The provider or supplier is 

deceased. 

• The provider or supplier is 

voluntarily withdrawing from Medicare. 

• The provider is the seller in an 

HHA change of ownership under 

§ 424.550(b)(1). 

Proposed reasons (a)(4) and (a)(5) 

reflect existing bases for revocation. We 

propose including them within 

§ 424.540 because, depending on the 

specific circumstances in question, they 

sometimes involve relatively modest 

instances of non-compliance that the 

provider or supplier can correct. 

Reasons (a)(6), (a)(7), and (a)(8) are 

merely technical, non-substantive 

deactivation grounds referenced in 

subregulatory guidance; a deactivation 

in these situations had simply ‘‘closed’’ 

the provider’s or supplier’s enrollment 

without the need for a revocation. 

Second, we propose to revise 

§ 424.540(b)(1) to state: ‘‘In order for a 

deactivated provider or supplier to 

reactivate its Medicare billing 

privileges, the provider or supplier must 

recertify that its enrollment information 

currently on file with Medicare is 

correct, furnish any missing information 

as appropriate, and be in compliance 

with all applicable enrollment 

requirements in this title.’’ The addition 

of the language concerning compliance 

is primarily meant to account for our 

addition of § 424.540(a)(4) and (5). The 

recertification of enrollment data alone 

would not be enough for providers and 

suppliers deactivated under either of 

these grounds; they (or, as applicable, 

their practice location(s)) must also have 

resumed compliance. However, this 

change would also clarify that 

compliance with all enrollment 

requirements would be required for 

providers and suppliers deactivated 

under § 424.540(a)(1), (a)(2), or (a)(3) to 

be reactivated. (We recognize that 

§ 424.540(b)(1) would be largely 

inapplicable to proposed deactivation 

grounds § 424.540(a)(6), (7), and (8) 

because the provider or supplier has 

effectively departed the Medicare 

program.) 

In new paragraph (d)(1)(i), and 

consistent with existing policy, we 

propose to specify that except as 

provided in paragraph (d)(1)(ii) of this 

section, the effective date of a 

deactivation is the date on which the 

deactivation is imposed under this 

section. In paragraph (d)(1)(ii), we 

propose that CMS may apply a 

retroactive deactivation effective date— 

based on the date that the provider’s or 

supplier’s action or non-compliance 

occurred or commenced (as 

applicable)—in the following instances 

(which would include our proposed 

new deactivation grounds, discussed 

previously): 

++ For deactivation reasons (a)(2), 

(3), and (4), the effective date would be 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35966 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

the date on which the provider or 

supplier became non-compliant (for 

example, the expiration of the period in 

which the provider was required to 

report a change in its enrollment 

information). 

++ For deactivation reason (a)(5), the 

date on which the provider’s or 

supplier’s practice location became nonoperational or otherwise invalid. 

++ For deactivation reason (a)(6), the 

date of death of the provider or supplier. 

++ For deactivation reason (a)(7), the 

date on which the provider or supplier 

voluntarily withdrew from Medicare. 

++ For deactivation reason (a)(8), the 

date of the sale. 

(c) Payment Prohibition 

We propose in new § 424.540(e) that 

a provider or supplier may not receive 

payment for services or items furnished 

while deactivated under § 424.540(a). 

We recognize that the PIM has 

permitted retroactive payment (once the 

provider or supplier is reactivated) for 

services furnished during the period of 

deactivation; current subregulatory 

guidance permits the provider or 

supplier to bill for services or items 

furnished up to 30 days prior to the 

effective date of the reactivation. After 

careful reflection, however, we believe 

that the most sensible approach from a 

program integrity perspective is to 

prohibit such payments altogether. In 

our view, a provider or supplier should 

not be effectively rewarded for its nonadherence to enrollment requirements 

(for example, failing to respond to a 

revalidation request or failing to timely 

report enrollment information changes) 

by receiving payment for services or 

items furnished while out of 

compliance; indeed, the prospect of a 

payment prohibition could well spur 

providers and suppliers to avoid such 

non-compliance. We believe proposed 

§ 424.540(e) would not only be an 

important payment safeguard in this 

regard but also would: (1) Clarify this 

important issue (which has created 

some confusion within the provider 

community); and (2) allow the public to 

furnish feedback on the topic. 

(d) Additional Revisions 

We also propose three additional 

clarifications to the deactivation 

provisions in § 424.540. First, the 

opening sentence of § 424.540(c) states 

that deactivation ‘‘is considered an 

action to protect the provider or 

supplier from misuse of its billing 

number and to protect the Medicare 

Trust Funds from unnecessary 

overpayments.’’ While this sentence is 

true, we previously mentioned other 

purposes of deactivation, such as 

encouraging providers and suppliers to 

remain compliant with Medicare 

requirements. Given the multiple 

rationales for the deactivation process, 

we believe the first sentence of 

§ 424.540(c) is too restrictive and 

propose to remove it. (The existing 

second sentence of § 424.540(c) would 

remain intact and comprise the whole of 

revised paragraph (c).) 

Second, and as alluded to previously, 

the concluding sentence of existing 

§ 424.540(a)(2) states that changes in 

ownership or control ‘‘must be reported 

within 30 calendar days as specified in 

§§ 424.520(b) and 424.550(b).’’ We 

propose to clarify that our existing 

deactivation authority under 

§ 424.540(a)(2) applies to both the 

changes that must be reported within 90 

days and those within 30 days. 

Consequently, we would delete the 

existing version of this paragraph and 

state that deactivation is permitted if the 

provider or supplier does not report a 

change to the information supplied on 

the enrollment application within the 

applicable time period required under 

this title. Our use of the word ‘‘title’’ 

would account for provisions in Title 42 

(such as those in § 424.516) that require 

certain provider and supplier types to 

report such changes within the 

timeframes specified therein. 

Third, under the applicable PIM 

guidance, the effective date of a 

reactivation is generally the date on 

which the Medicare contractor received 

the application that was processed to 

completion. To clarify this policy in 

regulation, we propose to add it as new 

§ 424.540(d)(2) with one modification, 

in that the word ‘‘completion’’ would be 

replaced with ‘‘approval.’’ This would 

make clear that the contractor would 

have to actually approve the application 

(rather than merely complete the 

processing thereof) in order for the 

reactivation to become effective. 

6. HHA Capitalization 

Under §§ 489.28(a) and 424.510(d)(9), 

an HHA entering the Medicare 

program—including a new HHA 

resulting from a change of ownership if 

the latter results in a new provider 

number being issued—must have 

sufficient funds (known as initial 

reserve operating funds) available: (1) At 

the time of application submission; and 

(2) at all times during the enrollment 

process, to operate the HHA for the 3- 

month period after the Medicare 

contractor conveys billing privileges 

(exclusive of actual or projected 

accounts receivable from Medicare). 

This means that the HHA must also 

have available sufficient initial reserve 

operating funds during the 3-month 

period following the conveyance of 

Medicare billing privileges. 

To enable CMS or the Medicare 

contractor to verify compliance with the 

requirements of §§ 489.28(a) and 

424.510(d)(9), the HHA must submit 

adequate proof of the availability of 

initial reserve operating funds. Section 

489.28(d) states that such proof must 

include, at a minimum, a copy of the 

statement(s) of the HHA’s savings, 

checking, or other account(s) that 

contains the funds, ‘‘accompanied by an 

attestation from an officer of the bank or 

other financial institution that the funds 

are in the account(s) and that the funds 

are immediately available to the HHA.’’ 

With respect to borrowed funds, 

§ 489.28(e) states that if such funds are 

not in the same account(s) as the HHA’s 

own non-borrowed funds, the HHA 

must provide proof that the borrowed 

funds are available for use in operating 

the HHA, by providing, at a minimum, 

a statement similar to the bank/financial 

institution officer attestation referenced 

in § 489.28(d). CMS has recently learned 

that several national bank chains are no 

longer providing these attestation 

statements, thus hindering the ability of 

HHAs to comply with § 489.28(d) or (e). 

To remedy this, we propose to insert the 

phrase ‘‘(if the financial institution 

offers such attestations)’’ after the term 

‘‘financial institution’’ as used 

§ 489.28(d) and (e). 

7. HHA Changes of Ownership 

Section 424.550(b) states that if there 

is a change in majority ownership of an 

HHA by sale within 36 months after the 

effective date of the HHA’s initial 

enrollment in Medicare or within 36 

months after the HHA’s most recent 

change in majority ownership, the 

HHA’s provider agreement and 

Medicare billing privileges do not 

convey to the new owner (hereafter 

occasionally referenced as the ‘‘36- 

month rule’’). Instead, the prospective 

provider/owner of the HHA must: (1) 

Enroll in Medicare as a new (initial) 

HHA; and (2) obtain a state survey or 

accreditation. We had seen situations 

where an HHA submitted an initial 

enrollment application, underwent a 

Sate survey, became Medicare-enrolled, 

and then promptly sold (or ‘‘flipped’’) 

the HHA (via our change of ownership 

regulations in § 489.18) to an 

unqualified party. This was problematic 

because the latter would not have to 

undergo a new State survey. By 

effectively imposing a 36-month 

‘‘waiting period’’ for HHA changes in 

majority ownership under § 424.550(b), 

we have been able to stem such 

instances of ‘‘flipping’’ or, if an HHA 

sale does occur within this timeframe, 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35967 

90Hospices are also subject to additional Federal 

civil rights laws, including the Age Discrimination 

Act, section 1557 of the Affordable Care Act, and 

conscience and religious freedom laws. 

fully scrutinize the new owner via a 

State survey and the initial provider 

enrollment process. This is particularly 

important given, as previously 

mentioned, the heightened program 

integrity risks that HHAs have 

historically presented. 

However, we recognize in 

§ 424.550(b) that there are instances 

where qualified HHAs change their 

ownership without any intent to 

circumvent a State survey or initial 

enrollment. Therefore, we created 

several exceptions in which the 36- 

month rule does not apply. One 

exception (identified in 

§ 424.550(b)(2)(i)) is that the HHA has 

submitted 2 consecutive years of full 

cost reports; we believe this 

circumstance indicates that the HHA 

has been legitimately and fully 

functioning for an extended period, thus 

negating to some extent our concern that 

the HHA may be engaged in ‘‘flipping.’’ 

There has been uncertainty within the 

provider community as to whether this 

particular exception applies only to the 

2-year cost report period after initial 

enrollment or also to 2-year cost report 

periods after the HHA’s previous change 

in majority ownership. In assessing 

whether an HHA has been operational 

and providing services for 2 consecutive 

years for purposes of the 36-month rule, 

we see no appreciable difference 

between a period following initial 

enrollment and one succeeding a change 

in majority ownership. We accordingly 

propose to revise the first sentence of 

§ 424.550(b)(2)(i) to specify that the 

HHA submitted 2 consecutive years of 

full cost reports since initial enrollment 

or the last change in majority 

ownership, whichever is later. (The 

second sentence of § 424.550(b)(2)(i), 

which clarifies that low utilization or no 

utilization cost reports do not qualify as 

full cost reports for purposes of 

§ 424.550(b)(2)(i), would remain intact.) 

VII. Survey and Enforcement 

Requirements for Hospice Programs 

A. Background 

Hospice care, as referenced in our 

regulations at § 418.3, means a 

comprehensive set of services described 

in section 1861(dd)(1) of the Act. These 

services are identified and coordinated 

by an interdisciplinary group to provide 

for the physical, psychosocial, spiritual, 

and emotional needs of a terminally ill 

patient and/or family members, as 

delineated in a specific patient plan of 

care that is individualized and personcentered. Hospice care is a 

comprehensive, holistic approach to 

treatment that recognizes the impending 

death of a terminally ill individual and 

warrants a change in the focus from 

curative care to palliative care for the 

relief of pain and symptom 

management. Medicare regulations at 

§ 418.3 define ‘‘palliative care’’ as 

patient and family-centered care that 

optimizes quality of life by anticipating, 

preventing, and treating suffering. 

Palliative care throughout the 

continuum of illness involves 

addressing physical, emotional, social, 

and spiritual needs and facilitating 

patient autonomy, access to 

information, and choice. Palliative care 

that is patient-centered and 

individualized is at the core of hospice 

philosophy and care practices, and is a 

critical component of the Medicare 

hospice benefit. 

The goal of hospice care is to help 

terminally ill individuals continue life 

with minimal disruption to normal 

activities while remaining primarily in 

the home environment. A hospice 

program uses an interdisciplinary 

approach to deliver medical, nursing, 

social, psychological, emotional, and 

spiritual services through a 

collaboration of professionals and other 

caregivers, to make the beneficiary as 

physically and emotionally comfortable 

as possible. 

As referenced in hospice program 

regulations at § 418.22(b)(1), to be 

eligible for Medicare hospice program 

services, the patient’s attending 

physician (if any) and the hospice 

program medical director must certify 

that the individual is ‘‘terminally ill,’’ as 

defined in section 1861(dd)(3)(A) of the 

Act and our regulations at § 418.3. The 

individual has a medical prognosis that 

his or her life expectancy is 6 months 

or less if the illness runs its normal 

course. Under the Medicare hospice 

program benefit, the election of hospice 

program care is a patient choice and 

once a terminally ill patient elects to 

receive hospice care, a hospice 

interdisciplinary group (IDG) is 

essential in the seamless provision of 

primarily home-based services. 

Hospice programs must comply with 

applicable civil rights laws,90 including 

section 504 of the Rehabilitation Act of 

1973 and the Americans with 

Disabilities Act, under which covered 

entities must take appropriate steps to 

ensure effective communication with 

patients and patient care representatives 

with disabilities, including the 

provisions of auxiliary aids and 

services. Additionally, they must take 

reasonable steps to ensure meaningful 

access for individuals with limited 

English proficiency, consistent with 

Title VI of the Civil Rights Act of 1964. 

Further information about these 

requirements may be found at: http://

www.hhs.gov/ocr/civilrights. 

1. Medicare Participation and Survey 

Activity 

Sections 1812(d), 1813(a)(4), 

1814(a)(7), 1814(i), and 1861(dd) of the 

Act, and the implementing regulations 

in 42 CFR part 418, establish eligibility 

requirements, payment standards, and 

procedures; define covered services; and 

delineate the conditions a hospice 

program must meet to be approved for 

participation as a provider in the 

Medicare program. Part 418, subpart G, 

provides for a per diem payment based 

on one of four prospectively-determined 

rate categories of hospice care (routine 

home care, continuous home care, 

inpatient respite care, and general 

inpatient care), based on each day a 

qualified Medicare beneficiary is under 

hospice care (once the individual has 

elected). This per diem payment is 

meant to cover all of the hospice 

services and items needed to manage 

the beneficiary’s care, as required by 

section 1861(dd)(1) of the Act. 

Section 1864(a) of the Act authorizes 

the State survey agencies (SAs) or other 

appropriate local agencies, under an 

agreement with CMS, to perform 

surveys of health care providers and 

suppliers to assess their compliance 

with the applicable Medicare 

conditions. There are several types of 

surveys conducted, including initial 

surveys (to receive initial certification), 

recertification surveys (to maintain 

certification), complaint surveys (to 

investigate complaints), and surveys for 

validation of the results of Accrediting 

Organization (AO) surveys. Only the SA 

or CMS may survey certain provider 

types because a CMS-approved AO 

option does not exist for their type, 

while others cannot be surveyed by SAs 

in accordance with the statute but can 

only be accredited by a CMS-approved 

AO (such as providers of the technical 

component of advanced diagnostic 

imaging). Based on the SA 

recommendations from survey findings, 

CMS determines whether the provider 

or supplier qualifies, or continues to 

qualify, for participation in the 

Medicare program. 

2. CMS Requirements for AOs Approved 

To Deem Hospice Programs 

Section 1865(a) of the Act allows most 

health care facilities to demonstrate 

their compliance with the Medicare 

conditions through accreditation by a 

CMS-approved program of an AO, 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35968 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

instead of being surveyed by SAs for 

certification. Currently CMS-approved 

accreditation programs for facilities 

under section 1865(a) of the Act include 

Ambulatory Surgical Centers (ASCs); 

Hospitals; Critical Access Hospitals 

(CAHs); Home Health Agencies (HHAs); 

Hospices; Outpatient Physical Therapy 

(OPT) facilities; End-Stage Renal 

Disease (ESRD) facilities; and Rural 

Health Clinics (RHCs). This is referred 

to as ‘‘deeming’’ accreditation. This is 

because CMS-approved AOs are 

recognized by the Secretary as having 

programs with accreditation standards 

that meet or exceed those of Medicare. 

Therefore, any provider or supplier that 

is accredited by an AO under a CMSapproved accreditation program is 

deemed by CMS to have also complied 

with the applicable Medicare conditions 

or requirements. Accreditation by an 

AO is generally voluntary on the part of 

the providers and suppliers, as they 

have the choice to seek accreditation 

from an approved AO or seek Medicare 

certification through the SA. 

CMS is responsible for—(1) providing 

continuous oversight of the AOs’ 

accreditation programs to ensure that 

providers or suppliers accredited by the 

AOs meet the required Medicare 

conditions or requirements; (2) ensuring 

that the AOs have formalized 

procedures to determine whether the 

health care facilities deemed under their 

accreditation programs meet the AO’s 

accreditation standards (which must 

meet or exceed the applicable Medicare 

program requirements); and (3) ensuring 

that the AO’s accreditation standards 

and practices for surveying providers 

and suppliers meet or exceed the 

Medicare conditions and practices for 

approving. 

The current regulations at § 488.4 set 

forth the general provisions for CMSapproved accreditation programs for 

providers and suppliers. The 

requirements at § 488.5 set out 

application and re-application 

procedures for national AOs that seek to 

obtain CMS approval of their 

accreditation programs, often called 

‘‘deeming authority.’’ These regulations 

task CMS with the responsibilities of 

approval and oversight of the AOs’ 

accreditation programs. 

As of March 2021, there are three AOs 

with CMS-approved hospice 

accreditation programs: Accreditation 

Commission for Health Care, Inc. 

(ACHC), Community Health 

Accreditation Partner (CHAP), and The 

Joint Commission (TJC). These three 

AOs survey approximately half of the 

over 5,000 Medicare-certified hospice 

programs, while the SAs survey the 

remaining half. 

B. Provisions of the Proposed Rule 

1. Overview 

Division CC, section 407 of the CAA 

2021, amended Part A of Title XVIII of 

Act to add a new section 1822 to the 

Act, and amended sections 1864(a) and 

1865(b) of the Act, establishing new 

hospice program survey and 

enforcement requirements. There are 

nine new survey and enforcement 

provisions. The law requires public 

reporting of hospice program surveys 

conducted by SAs and AOs, as well as 

enforcement actions taken as a result of 

these surveys, on CMS’s website in a 

manner that is prominent, easily 

accessible, searchable and readily 

understandable format. It also removes 

the prohibition at section 1865(b) of the 

Act of public disclosure of hospice 

surveys performed by AOs, requiring 

that AOs use the same survey deficiency 

reports as SAs (Form CMS–2567, 

‘‘Statement of Deficiencies’’ or a 

successor form) to report survey 

findings. The law requires programs to 

measure and reduce inconsistency in 

the application of survey results among 

all surveyors. The law requires the 

Secretary to provide comprehensive 

training and testing of SA and AO 

hospice program surveyors, including 

training with respect to review of 

written plans of care. The statute 

prohibits SA surveyors from surveying 

hospice programs for which they have 

worked in the last 2 years or in which 

they have a financial interest, requires 

hospice program SAs and AO to use a 

multidisciplinary team of individuals 

for surveys conducted with more than 

one surveyor (to include at least one 

registered nurse (RN)), and provides that 

each SA must establish a dedicated tollfree hotline to collect, maintain, and 

update information on hospice 

programs and to receive complaints. 

Finally, the law directs the Secretary to 

create a Special Focus Program (SFP) for 

poor-performing hospice programs, sets 

out authority for imposing enforcement 

remedies for noncompliant hospice 

programs, and requires the development 

and implementation of a range of 

remedies as well as procedures for 

appealing determinations regarding 

these remedies. These enforcement 

remedies can be imposed instead of, or 

in addition to, termination of the 

hospice program’s participation in the 

Medicare program. These remedies 

include civil money penalties (CMPs), 

suspension of all or part of payments, 

and appointment of temporary 

management to oversee operations. 

The provision requiring a new 

hospice program hotline is effective 1 

year after the CAA 2021 enactment (that 

is, December 27, 2021). Most other 

provisions are effective on October 1, 

2021, including the following—the 

requirement to use multidisciplinary 

survey teams, the prohibition of 

conflicts of interest, expanding CMSbased surveyor training to AOs, and the 

requirement for AOs with CMSapproved hospice accreditation 

programs to begin use of the Form 

CMS–2567 (or a successor form). The 

public disclosure of survey information 

and the requirement to develop and 

implement a range of enforcement 

remedies is effective no later than 

October 1, 2022. The other provisions in 

the legislation were effective upon 

enactment of the CAA 2021. 

In this proposed rule, we are 

proposing a comprehensive strategy to 

enhance the hospice program survey 

process, increase accountability for 

hospice programs, and provide 

increased transparency to the public. 

Our goals include: (1) Maintaining the 

public trust through addressing conflicts 

of interest and improving survey 

transparency; (2) addressing 

inconsistency within the survey process 

through training and survey team 

composition and use of common 

hospice program deficiency reporting 

mechanisms; and (3) ensuring hospice 

programs are held accountable for 

addressing identified health and safety 

issues. The statutory requirements 

outlined in the CAA 2021 will address 

CMS’ goals and are in the best interest 

of patients who receive care in 

Medicare-participating hospice 

programs. 

We propose to add new subparts M 

and N to 42 CFR part 488 to implement 

the CAA 2021 requirements. Subpart M 

would provide survey and certification 

processes while subpart N would 

provide the enforcement remedies for 

hospice programs with deficiencies that 

are not in compliance with Medicare 

participation requirements. The 

proposed enforcement remedies for 

hospice programs with deficiencies are 

similar to the alternative enforcement 

sanctions available for HHAs with 

deficiencies. We propose to amend 

§ 488.2 and § 488.28, where appropriate, 

to include the reference to hospice 

program. In addition, we propose to 

amend terminations and appeals 

requirements in 42 CFR parts 489 and 

498 based on the proposed enforcement 

remedies. 

2. Subpart A—General Provisions 

a. Statutory Basis (§§ 488.2 and 498.1) 

The CAA 2021 amended Part A of 

title XVIII of the Act to add section 1822 

of the Act on hospice program survey 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35969 

91CMS–2567 available at: https://www.cms.gov/ 

Medicare/CMS-Forms/CMS-Forms/Downloads/ 

CMS2567.pdf. 92 iQIES is available at: https://iqies.cms.gov/. 

and enforcement procedures. We 

propose to amend the requirement at 

§ 488.2 and at § 498.1 to include this 

statutory reference to hospice program 

services. 

b. Application and Re-Application 

Procedures for National Accrediting 

Organizations (§ 488.5) 

We propose at § 488.5(a)(4)(x) to 

require the AOs, as part of a hospice 

program AO’s application and 

reapplication process, to submit a 

statement acknowledging that the AO 

will include a statement of deficiencies 

(that is, the Form CMS–2567 or a 

successor form) to document findings of 

the hospice program Medicare CoPs 

under section 1822(a)(2)(A)(ii) of the 

Act and will submit such in a manner 

specified by CMS. 

Currently, the regulations under 

§ 488.5 do not require AOs to utilize the 

same forms as SA surveyors when 

documenting survey findings of 

noncompliance. Specifically, 

§ 488.5(a)(4)(ii) in part states that AOs 

with CMS-approved programs must 

submit documentation demonstrating 

the comparability of the organization’s 

survey process and surveyor guidance to 

those required for State survey agencies 

conducting Federal Medicare surveys 

for the same provider or supplier 

type. . . . Therefore, AOs are not 

required to and do not utilize the Form 

CMS–2567 to report their survey 

findings, nor do they use the same 

software system used by SAs to capture 

the information. Each of the three AOs 

with CMS-approved hospice program 

deeming authority, has a unique 

software system that is proprietary to 

the organization and develops a unique 

survey report for their deemed hospice 

organizations. These systems are 

platforms for AO/client communication 

as well as document storage and are 

unique to the AOs standards and 

process, which may meet or exceed 

those of CMS. The AO’s survey reports, 

provided to hospice program clients, set 

out the deficiencies related to CMS 

requirements, as well as any additional 

AO standards combined into one report. 

The Form CMS–2567 Statement of 

Deficiencies and Plan of Correction 91 is 

the legal, documentary basis for how 

SAs and CMS Federal surveyors note 

findings of compliance or 

noncompliance (deficiencies) resulting 

from an inspection of Medicareparticipating providers and suppliers. 

Our regulations at § 488.18 require that 

SAs document all deficiency findings 

on a statement of deficiencies, which is 

the Form CMS–2567. 

Additionally, §§ 488.26 and 488.28 

further delineate how findings must be 

recorded and that CMS prescribed forms 

must be used. The Form CMS–2567 is 

used to state concisely and in a standard 

format, whether or not any deficiencies 

were identified during a survey, 

including the evidence to support each 

finding. Following the survey, the 

provider/supplier will use the form to 

document their plan for correcting the 

identified deficiencies. 

The completed Form CMS–2567 

exists in PDF format and is also 

compiled by the CMS Automated 

Survey Processing Environment 

(ASPEN) survey software, which is the 

current national database, designed to 

help SAs collect and manage healthcare 

provider data. CMS is in the process of 

transitioning the ASPEN software 

system to a new, web-based internet 

Quality Improvement and Evaluation 

System (iQIES).92 In mid-2021, CMS 

will begin transitioning to the new 

software system on a program-specific 

implementation schedule, starting with 

HHAs. It may take several years to fully 

transition all programs to the new 

technology platform, and CMS will 

continue to evaluate documentation 

needs, make necessary system 

adjustments with each program that 

transitions, and train surveyors on 

system use. 

Currently, AOs are able to access the 

online PDF version of the Form CMS– 

2567 but do not have access to the CMS 

ASPEN system, as this software was 

only designed and distributed for use by 

SAs and CMS employees. CMS and the 

AOs must therefore determine the 

systems process for the inclusion and 

subsequent collection of the Form CMS– 

2567 as part of all deemed hospice 

program surveys completed by AOs. 

CMS already requires all AO survey 

reports to identify the comparable 

Medicare CoPs for each finding of 

noncompliance with accreditation 

standards (§ 488.5(a)(4)(iv)). Therefore, 

in order to meet the new statutory 

requirement for hospice program AOs to 

also use the Form CMS–2567 (or a 

successor form), each of the three CMSapproved hospice program AOs must 

now develop a way to incorporate this 

form into their data systems. 

As required by § 488.5(a)(11)(ii), AOs 

submit their survey findings to CMS. 

The database, Accrediting Organization 

System for Storing User Recorded 

Experiences (ASSURE), is currently 

used by AOs to provide CMS with 

survey data from its deemed facilities. 

The ASSURE system requires the AO to 

match its specific survey findings and 

comparable AO standards to the 

Medicare conditions or requirements by 

uploading a spreadsheet text file, 

designed based on the data fields in the 

system, or by manually inputting the 

information. At this time, the ASSURE 

system does not and cannot develop a 

statement of deficiencies Form CMS– 

2567, as ASPEN does for SA surveyors, 

because ASSURE was designed to 

capture survey details and findings 

based on the requirements for AOs at 

§ 488.5. 

CMS is currently assessing the 

systems revisions needed for each of the 

three database options (ASPEN, 

ASSURE, and iQIES) to determine if one 

of the systems could be a future vehicle 

for hospice program AOs to document 

their survey findings in the same 

manner as SAs and subsequently have 

those forms easily captured by CMS for 

reporting purposes. Since ASPEN and 

ASSURE are nearing the end of their 

lifecycle, as CMS transitions to iQIES, it 

may not be prudent for CMS to invest 

resources and redistribute funding 

intended to update the future system to 

update legacy systems. At this time, it 

is most important for AOs to develop a 

way of incorporating the Form CMS– 

2567 into their documentation systems. 

As their systems are proprietary, CMS is 

unable to tell the AOs exactly how to 

incorporate the Form CMS–2567, but we 

will work with the AOs to determine 

how their version can be submitted to 

CMS via electronic data exchange. 

Separately from the systems issues, 

the existing format of the Form CMS– 

2567 must be modified, as it does not 

currently have a place for the name of 

the AO that is performing the survey as 

this form was historically only used by 

SAs. Consequently, the form directions 

do not refer to AOs. Since this is a 

public document that is frequently used 

by consumers, advocacy groups, and the 

public as a source of information about 

quality of care and facility compliance, 

CMS must make updates to the form to 

include AO information so it is clear 

who performed the survey. CMS is in 

the process of seeking the Office of 

Management and Budget (OMB) 

approval of this revised form for 

information collection, in accordance 

with provisions of the Paperwork 

Reduction Act (PRA). For further 

discussion on PRA implications and 

timeline, see the collection of 

information requirements in section X. 

of this proposed rule. 

We seek public comment on how AOs 

can customize their proprietary systems 

to incorporate a version of the Form 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35970 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

93Quality, Certification and Oversight Reports 

(QCOR). 

CMS–2567 and then submit it to CMS 

via electronic data exchange. 

c. Release and Use of Accreditation 

Surveys (§ 488.7) 

We propose to add a new § 488.7(c), 

which would require the posting of the 

Form CMS–2567 in a manner that is 

prominent, easily accessible, readily 

understandable, and searchable for the 

general public and allows for timely 

updates. Prior to the CAA 2021, CMS 

did not have the authority to publish 

AO surveys for deemed hospice 

programs except to the extent that the 

AO survey and survey information are 

related to an enforcement action taken 

by CMS against the provider. However, 

CMS may post State agency complaint 

or validation survey results of deemed 

hospice providers; CMS utilizes the 

Quality, Oversight, and Certification 

Reports (QCOR) 93 public website for 

this purpose. 

As mentioned in section VII.B.1.b. of 

this proposed rule, CMS recognizes 

there are challenges related to the 

system implications for use of the Form 

CMS–2567 by the AOs. However, as 

directed by Congress, we are removing 

the prohibition that previously allowed 

AO hospice program survey reports to 

be considered confidential and 

proprietary. We are proposing to require 

that AOs release deficiency reports for 

hospice program surveys conducted 

under their respective deeming 

authority to increase transparency 

among the hospice beneficiary 

community. 

CMS will need to address various 

system integrations and updates to 

integrate AO survey results on the Form 

CMS–2567 as mentioned in section 

VII.B.2.b. of this proposed rule. 

Furthermore, CMS recognizes there are 

limitations and additional data system 

changes to consider for survey results 

from the Form CMS–2567 to be 

displayed in a meaningful and useful 

format. 

We seek public comments as to how 

data elements from the Form CMS–2567 

may be utilized and displayed, and 

other recommendations of relevant 

provider information, to assist the 

public in obtaining a more 

comprehensive understanding of a 

hospice program’s overall performance. 

CAA 2021 requires that CMS publish 

survey information from the Form 

CMS–2567 in a way that is readily 

understandable and useable by the 

public in a meaningful way. We 

anticipate the need for us to develop 

some type of a standard framework that 

would identify salient survey findings 

in addition to other relevant data about 

the hospices’ performance. We 

recognize that the implications of 

releasing national survey data will 

require collaboration with industry 

stakeholders to assure the development 

is fair and equitable across all hospice 

programs. 

d. Providers or Suppliers, Other Than 

SNFs, NFs, HHAs, and Hospice 

Programs With Deficiencies (§ 488.28) 

Currently, the regulation at § 488.28 

states that if a provider or supplier is 

deficient in one or more of the standards 

set out in such provider’s or supplier’s 

CoPs, it must submit an acceptable plan 

of correction (POC) for achieving 

compliance. An acceptable POC must be 

received within a reasonable time 

acceptable to CMS to continue Medicare 

participation. If it is determined during 

a survey that a provider or supplier is 

not in compliance with one or more of 

the standards in the CoPs, it is granted 

a ‘‘reasonable time’’ to achieve 

compliance. The amount of time 

depends upon the nature of the 

deficiency and the SA’s discretionary 

determination as to whether the facility 

can provide adequate and safe care. 

Ordinarily, a provider or supplier is 

expected to take the steps needed to 

achieve compliance within 60 days of 

being notified of the deficiencies. 

However, the SA may recommend 

additional time be granted based on 

individual situations if it is not 

reasonable to expect compliance within 

60 days. The regulation exempts SNFs, 

NFs, and HHAs from this requirement; 

instead, similar provisions are set out in 

the regulations relating to those specific 

provider-types. 

Section 1822(c) of the Act authorizes 

the Secretary to take actions to ensure 

the removal and correction of conditionlevel deficiencies in a hospice program 

through an enforcement remedy or 

termination or both. The enforcement 

remedy requirements for hospice 

programs are outlined in the proposed 

new subpart N. Regardless of which 

remedy is applied, a non-compliant 

hospice program must still submit a 

POC for approval by the SA or CMS. 

The POC is a plan developed by the 

hospice program and approved by CMS 

that is the hospice program’s written 

response to survey findings detailing 

corrective actions to cited deficiencies 

and the hospice program specifies the 

date by which those deficiencies will be 

corrected. We propose revising the 

heading for § 488.28 to indicate that 

hospice programs with deficiencies 

would also be exempt from the 

enforcement requirements set out in that 

section of our rules. 

3. Proposed New Subpart M—Survey 

and Certification of Hospice Programs 

a. Basis and Scope (§ 488.1100) 

The proposed regulation at § 488.1100 

would specify the statutory authority 

and general scope of the hospice 

program. In general, this proposed rule 

is based on the rulemaking authority in 

section 1822 of the Act as well as 

specific statutory provisions identified 

in the preamble where appropriate. 

b. Definitions (§ 488.1105) 

We propose to add definitions at 

§ 488.1105 for survey and enforcement 

terms for hospice programs. The 

definitions proposed for hospice 

programs include the following: 

• Abbreviated standard survey would 

mean a focused survey other than a 

standard survey that gathers information 

on hospice program’s compliance with 

specific standards or CoPs. An 

abbreviated standard survey may be 

based on complaints received or other 

indicators of specific concern. Examples 

of other indicators include media 

reports or findings of government 

oversight activities, such as OIG 

investigations. 

• Complaint survey would mean a 

survey that is conducted to investigate 

substantial allegations of 

noncompliance as defined in § 488.1. 

• Condition-level deficiency would 

mean noncompliance as described in 

§ 488.24 of this part. 

• Deficiency would mean a violation 

of the Act and regulations contained in 

42 CFR part 418, subparts C and D, is 

determined as part of a survey, and can 

be either standard or condition-level. 

• Noncompliance would mean any 

deficiency found at the condition-level 

or standard-level. 

• Standard-level deficiency would 

mean noncompliance with one or more 

of the standards that make up each 

condition of participation for hospice 

programs. 

• Standard survey would mean a 

survey conducted in which the surveyor 

reviews the hospice program’s 

compliance with a select number of 

standards and/or CoPs to determine the 

quality of care and services furnished by 

a hospice program. 

• Substantial compliance would 

mean compliance with all conditionlevel requirements, as determined by 

CMS or the State. 

c. Hospice Program Surveys and 

Hospice Program Hotline (§ 488.1110) 

At proposed § 488.1110(a), a standard 

survey would have to be conducted not 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35971 

later than 36 months after the date of the 

previous standard survey, as specified 

in section 1822(a)(1) of the Act. A 

survey could be conducted more 

frequently than 36 months to assure that 

the delivery of quality hospice services 

complies with the CoPs and confirm 

that the hospice program corrected 

deficiencies that were previously cited. 

At proposed § 488.1110(b)(1), a standard 

or abbreviated standard survey would 

have to be conducted when complaint 

allegations against the hospice program 

were reported to CMS, the State, or local 

agency. Additionally, we recognize that 

for AOs with hospice deeming 

programs, the proposed 36-month 

surveys would mirror the requirements 

for AOs to describe the frequency of 

surveys as part of the AO application 

process at existing § 488.5(a)(4)(i). That 

provision requires AOs to agree to 

survey and re-survey every accredited 

provider or supplier, through 

unannounced surveys, no later than 36 

months after the prior accreditation 

effective date, or shorter if there is a 

statutorily mandated survey interval of 

fewer than 36 months. 

Prior to the amendments made by 

CAA 2021, section 1864(a) of the Act 

required that agreements between the 

Secretary and the State, under which 

SAs carry out the Medicare certification 

process, shall provide for the 

appropriate State or local agency to 

establish and maintain a toll-free hotline 

for HHAs. The CAA 2021 amended this 

requirement to include hospice 

programs. The provision now requires 

that a hotline must be maintained: (1) 

To collect, maintain, and continually 

update information on HHAs and 

hospice programs located in the State or 

locality that are certified to participate 

in the program established under this 

title; and (2) to receive complaints (and 

answer questions) with respect to HHAs 

and hospice programs in the State or 

locality. Section 1864(a) of the Act also 

provides that such agreements shall 

provide for the State or local agency to 

maintain a unit for investigating such 

complaints that possesses enforcement 

authority and has access to survey and 

certification reports, information 

gathered by any private accreditation 

agency utilized by the Secretary under 

section 1865 of the Act, and consumer 

medical records (but only with the 

consent of the consumer or his or her 

legal representative). We propose to 

build on these same requirements for 

hospice programs consistent with the 

amendments made to section 1864(a) of 

the Act by CAA 2021. 

Therefore, at § 488.1110(b)(2) we 

propose that the State or local agency is 

responsible for establishing and 

maintaining a toll-free hotline to receive 

complaints (and answer questions) with 

respect to hospice programs in the State 

or locality and for maintaining a unit to 

investigate such complaints. The 

requirement for the hotline will be 

described in the annual CMS Quality, 

Safety and Oversight Group’s Mission 

and Priority Document (MPD) that 

serves as the scope of work which State 

Agencies are bound contractually via 

section 1864 of the Act (42 U.S.C. 

1395aa). 

As we plan for the implementation of 

the hospice toll-free hotline to 

streamline and enhance the complaint 

process for hospice program 

beneficiaries, we seek public comment 

on current experiences with the HHA 

toll-free hotline as required by section 

1864(a) of the Act. This information will 

inform CMS of future enhancements to 

the toll-free hotline. Specifically, what 

data elements and processes should be 

included to assure confidentiality and 

immediate communication with 

relevant SAs in order to permit them to 

respond promptly. 

d. Surveyor Qualifications and 

Prohibition of Conflicts of Interest 

(§ 488.1115) 

Section 1822(a)(4)(C) of the Act 

requires the Secretary to provide 

training for State and Federal surveyors, 

and any surveyor employed by an AO, 

including a training and testing program 

approved by the Secretary, no later than 

October 1, 2021. Further, no surveyor 

can conduct hospice program surveys 

until they complete training and testing. 

Currently, AOs are required by 

§ 488.5(a)(8) to provide training to their 

surveyors. As the AO requirements 

outlined in § 488.5 also allow for 

standards and processes that exceed 

those of CMS, the AO’s training may 

differ from what CMS provides to SA 

surveyors, thereby creating a potential 

disparity in overall survey performance. 

At § 488.1115, we propose that all SA 

and AO hospice program surveyors 

would be required to take CMSprovided surveyor basic training 

currently available, and additional 

training as specified by CMS. As part of 

the AO application and reapplication 

process under § 488.5(a)(8), the AO is 

required to submit a description of the 

content and frequency of the 

organization’s in-service training it 

provides to survey personnel. Under 

proposed § 488.1115, AO surveyors 

would be required to complete the 

online CMS hospice program basic 

training. CMS proposes that until the 

rule is finalized, that it accept the 

current AO training, that was previously 

reviewed and approved by CMS during 

the AO application process. State 

agency surveyors should already be in 

compliance with this requirement. 

AOs already have voluntary access to 

our Quality, Safety & Education Portal 

(QSEP), which contains the CMS 

training. Currently, the trainings are 

available free of charge through the 

QSEP website at https://qsep.cms.gov, to 

providers and all entities conducting 

surveys, including AOs, and the public 

at large. QSEP training is accessible on 

an individual, self-paced basis. 

The basic training online courses 

provide surveyors with the key 

knowledge and skills needed to survey 

the respective provider or supplier type 

for compliance with the Medicare 

conditions and assure an adequately 

trained, effective surveyor workforce. 

The online courses also help develop 

and refine surveying skills, promote 

critical thinking skills, and enhance 

surveyors’ overall ability to conduct and 

document surveys. Users may access the 

online courses at any time. This allows 

surveyors to refresh knowledge 

regarding Medicare conditions and 

processes whenever necessary. The 

number of learners trained in online 

courses has steadily increased since the 

courses’ inception. 

We are updating the hospice program 

basic training and including enhanced 

guidance for surveyors. The updated 

training will emphasize assessment of 

quality of care. Specifically, we would 

emphasize four ‘‘core’’ hospice program 

CoPs in revisions to the CMS State 

Operations Manual (SOM) (Pub. 100– 

07). The four core CoPs (identified in 

the preamble of the final rule, Medicare 

and Medicaid Programs; Hospice 

Conditions of Participation (73 FR 

32088, June 5, 2008)) are § 418.52 

Condition of Participation: Patient’s 

rights; § 418.54 Condition of 

Participation: Initial and comprehensive 

assessment of the patient; § 418.56 

Condition of Participation: 

Interdisciplinary group, care planning 

and coordination of care; and, § 418.58 

Condition of Participation: Quality 

assessment and performance 

improvement. The revised training, 

which we expect to be implemented 

soon, emphasizes the requirements for 

establishing individualized written 

plans of care, which are integral to the 

delivery of high quality care, and 

regularly updating these plans with the 

full involvement of the interdisciplinary 

team, patients, and their families. 

Despite the emphasis placed on these 

core CoPs, hospice programs must 

comply with all CoPs to achieve 

successful certification. 

We invite commenters to review the 

trainings by signing up for a free 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35972 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

94CMS State Operations Manual, Chapter 4 

Medicare State Operations Manual (cms.gov) 

(internet Only Manual, Pub. 100–07) 

account on the homepage of the CMS 

website, or by choosing the ‘‘Public 

Access’’ button on the upper right-hand 

corner of the website homepage. We 

seek comments on the requirement for 

continued SA and AO surveyor training 

as CMS releases additional basic course 

updates. 

In addition to training requirements 

for surveyors, we propose to set out the 

circumstances that will disqualify a 

surveyor from surveying a particular 

hospice in accordance with section 

1822(a)(4)(B) of the Act. While the 

statute specifically addresses SA 

surveyors, CMS takes prohibiting 

violations of public trust for those 

representing the Medicare program very 

seriously and therefore we are 

proposing to include hospice AO 

surveyors under this proposed 

requirement as well. 

In 2012, as part of an effort to mitigate 

conflicts of interest in the HHA survey 

process, CMS established requirements 

at § 488.735(b) to outline circumstances 

that disqualify a surveyor from 

performing HHA surveys. For example, 

if the surveyor currently serves, or 

within the previous 2 years has served, 

on the staff of or as a consultant to the 

HHA undergoing the survey, they would 

be disqualified for a conflict of interest. 

Chapter 4, Section 4008 of the SOM 

states, ‘‘conflicts of interest may arise 

within the Medicare/Medicaid 

certification program when public 

employees utilize their position for 

private gain or to secure unfair 

advantages for outside associates. The 

gain involved may or may not be 

monetary. Abuses of privileged 

information, abuses of influence, and 

other abuses of trust are included, 

regardless of whether a monetary 

advantage is gained or sought.’’ 94

Individual health care professionals, 

such as physicians or nurses, commonly 

have concurrent employment 

relationships with more than one health 

care setting. Many health care 

professionals, such as physicians, 

physician assistants, and nurse 

practitioners have multi-setting 

practices or are employed at more than 

one health care facility. For example, a 

registered nurse (RN) may work on staff 

at a hospital but also work at other 

hospitals through a medical staffing 

agency. In addition, as employees of a 

health care facility, these health care 

professionals could gain a financial 

interest in the health care facility 

through means such as being a 

contributor to the construction costs of 

a new wing of the facility or buying 

stock in the facility or its parent 

corporation. Management employees 

could be awarded stock or stock options 

for the facility or its parent corporation 

as part of their compensation and 

benefits package. 

SAs and AOs often hire surveyors that 

are also employed at one or more 

outside health care settings because the 

professional associations, expertise, 

knowledge, and skills held by these 

health care practitioners make them an 

asset as a surveyor. Longstanding CMS 

policy noted in section 4008 of the SOM 

describes examples of scenarios that 

would be conflicts of interest for SA 

surveyors of any provider or supplier 

type, including surveyors who have an 

outside relationship with a facility that 

is surveyed by the SA. However, the 

SOM generally applies only to SA 

surveyors, not AO surveyors. Therefore, 

we propose to codify these longstanding policies for both SA and AO 

surveyors to ensure there is no conflict 

of interest between the organization and 

the surveyor. 

We propose that a surveyor would be 

prohibited from surveying a hospice 

program if the surveyor currently serves, 

or within the previous 2 years has 

served, on the staff of or as a consultant 

to the hospice program undergoing the 

survey. Specifically, the surveyor could 

not have been a direct employee, 

employment agency staff at the hospice 

program, or an officer, consultant, or 

agent for the surveyed hospice program 

regarding compliance with the CoPs. A 

surveyor would be prohibited from 

surveying a hospice program if he or she 

has a financial interest or an ownership 

interest in that hospice. The surveyor 

would also be disqualified if he or she 

has an immediate family member who 

has a financial interest or ownership 

interest with the hospice program to be 

surveyed or has an immediate family 

member who is a patient of the hospice 

program to be surveyed. 

In regards to the definition of 

‘‘immediate family member’’ in the 

previous statement, we will utilize the 

definition of ‘‘immediate family 

member’’ located at § 411.351, which 

was also used for the development of 

similar HHA regulations (see 77 FR 

67140). This definition includes 

husband or wife; birth or adoptive 

parent, child, or sibling; stepparent, 

stepchild, stepbrother, or stepsister; 

father-in-law, mother-in-law, son-inlaw, daughter-in-law, brother-in-law, or 

sister-in-law; grandparent or grandchild; 

and spouse of a grandparent or 

grandchild. 

e. Survey Teams (§ 488.1120) 

The CAA 2021, adding section 

1822(a)(4)(A) of the Act, calls for the use 

of multidisciplinary survey teams when 

the survey team comprises more than 

one surveyor, with at least one person 

being a RN. Currently, the SOM, 

Appendix M—Guidance to Surveyors 

requires that each hospice program 

survey team include at least one RN, 

and, if the team is more than one 

surveyor, the additional surveyors 

should include other disciplines with 

the expertise to assess hospice program 

compliance with the conditions of 

participation. We propose at § 488.1120 

under a new subpart M to require that 

all survey entities—SA or AOs—include 

diverse professional backgrounds among 

their surveyors to reflect the 

professional disciplines responsible for 

providing care to persons who have 

elected hospice care. Such 

multidisciplinary teams should include 

professions included in hospice core 

services at 42 CFR 418.64, and may 

include physicians, nurses, medical 

social workers, pastoral or other 

counselors—bereavement, nutritional, 

and spiritual. To fulfill CAA 2021 

requirements, SAs and AOs might need 

time to reconstruct their workforce to 

accommodate the new requirements for 

hospice program surveys to utilize 

multidisciplinary teams.—We recognize 

that SAs and AOs may incur additional 

costs, given the varying, and potentially 

higher rates of average pay for some 

disciplines. Surveying entities may need 

up to a year to hire and train surveyors 

from the needed disciplines, depending 

on the timing of the attrition of current 

staff and workforce availability of the 

appropriately experienced 

professionals. In addition, as we 

proceed with implementation of this 

provision, CMS seeks to better 

understand the current professional 

makeup of survey entities’ workforces. 

In order to track compliance with this 

provision, we propose to establish a 

baseline knowledge by asking survey 

entities to tell us: (1) The extent to 

which their surveys are conducted by 

one professional, who by regulation 

must be a registered nurse; (2) the 

professional makeup of their current 

workforce; and (3) estimate a timeframe 

in which they could effectuate 

multidisciplinary teams if not already in 

place. We would provide additional 

guidance with instruction for the survey 

entities regarding the submission of this 

information to CMS. 

Our rules at § 418.56 require that 

hospice programs use interdisciplinary 

teams or groups to determine a holistic 

plan of care for the hospice program 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35973 

patient and family. The 

interdisciplinary group or IDG, must 

include, but not be limited to a 

physician, a registered nurse, a medical 

social worker, and pastoral or other 

counselor. Therefore, we propose that 

when the survey team comprises more 

than one surveyor, the additional slots 

would be filled by professionals from 

among these disciplines, and we are 

seeking comments on this approach. 

Similarly, section 1819(g)(2)(E) of the 

Act and 42 CFR 488.314 require that 

long-term care facility surveys be 

conducted by a multidisciplinary team 

of professionals, at least one of whom 

must be a RN. 

Our certification guidance in Chapter 

2 of the SOM provides details as to how 

the survey agency might select the 

appropriate disciplines for a survey 

team. SOM, Chapter 2 states that various 

professional disciplines should 

represent the expertise needed to 

determine compliance with the CoPs, 

standards, or requirements for that 

provider/supplier group. In establishing 

multidisciplinary teams under new 

section 1822(a)(4)(A) of the Act, we 

would consider, as a model, our current 

CMS guidance for long-term care 

facilities, which uses specialty 

surveyors with expertise not typically 

included in a survey team (for example, 

a pharmacist, physician, or registered 

dietitian), who may not be needed for 

the entire survey, but must be onsite at 

some time during the survey. 

f. Consistency of Survey Results 

(§ 488.1125) 

New section 1822(a)(3) of the Act 

requires that each State and the 

Secretary implement programs to 

measure and reduce inconsistency in 

the application of hospice program 

survey results among surveyors. In 

addition to ensuring consistency of 

hospice survey results across SAs, we 

believe that this also applies to reducing 

discrepancies between SA and AO 

surveys of hospice providers. Survey 

consistency has been a longstanding 

concern for CMS at multiple levels— 

interstate and intrastate, as well as 

Federal to state. While there are 

multiple strategies currently in place, as 

described in this section, to directly 

address the matters presented in the 

CAA 2021, we propose at § 488.1125 to 

enhance the requirements of the State 

Performance Standards System (SPSS) 

to direct States to implement processes 

to measure the degree or extent to which 

surveyors’ findings and determinations 

are aligned with federal regulatory 

compliance and with an SA supervisor’s 

determinations. Given the variation 

among State agencies with respect to the 

number of surveyors deployed for a 

particular survey, or the distribution of 

surveyor professional backgrounds, 

CMS expects to promulgate objective 

measures of survey accuracy, and seeks 

public opinion on what measures would 

be feasible for States. We desire 

measures that are both specific and 

utilize currently collected data, if 

possible. Accuracy could include 

whether a survey finding aligns with the 

selected regulatory deficiency, as well 

as failing to cite such findings. When 

applied to survey findings, the measures 

should allow CMS to determine the 

need for corrective action or education 

for individual surveyors or for a group 

of surveyors. If systemic issues are 

found, CMS is prepared to enhance its 

training to address systemic issues 

found as a result of interstate analysis. 

CMS monitors the consistency of SA 

surveys through a review of an SA’s 

Form CMS–2567s (the Statement of 

Deficiencies and Plan of Correction), 

which is conducted by its assigned CMS 

Survey Operations Group (SOG) 

Location, and consistency among AOs 

through validations surveys conducted 

by SAs. The SAs perform validation 

surveys on a sample of providers and 

suppliers (such as hospitals, CAHs, 

ASCs, Hospice Programs, and HHAs) 

accredited by the AOs. Validation 

surveys report disparate findings as the 

percentage of validation surveys that 

have conditions identified by the SA but 

missed by the AO survey team. This 

percentage is referred to as the 

‘‘disparity rate’’ and is tracked by CMS 

as an indication of the quality of the 

surveys performed by the AO. This is 

reported annually in a report to 

Congress (QSO–19–17–AO/CLIA). The 

most recent report can be found at 

https://www.cms.gov/Medicare/ 

Provider-Enrollment-and-Certification/ 

SurveyCertificationGenInfo/ 

Administrative-Information-Memos-tothe-States-and-Regions-Items/ 

AdminInfo-20-02-ALL. 

Using the disparity rate approach 

used with AOs, where surveys are 

reviewed for condition-level 

deficiencies the AO fails to identify, we 

propose to analyze trends in the 

disparity rate among States, as well as 

among AOs. State surveys results would 

be reviewed to identify findings that 

were potentially worthy of conditionlevel citation but were not cited. 

We believe that the disparate 

deficiency citations between AO 

surveyors and SA surveyors may, in 

part, be attributed to differences in 

surveyor training and education. This 

variation may be due to inconsistencies 

in AO training with the CMS-provided 

SA basic surveyor training. We believe 

that uniform surveyor training would 

increase the consistency between the 

results of the surveys performed by SAs 

and AOs, and have a positive impact on 

the high disparity rates. We also want to 

align our processes more closely to 

those CMS has found effective for other 

provider types. For instance, what we 

propose now, for hospice, is similar to 

what is done with nursing homes, 

where validation surveys are described 

at section 1819(g)(3)(A) of the Act as 

‘‘. . . a representative sample of skilled 

nursing facilities in each State, within 2 

months of the date of surveys conducted 

under paragraph (2) by the State, in a 

sufficient number to allow inferences 

about the adequacies of each State’s 

surveys . . . (B) . . . each year 

concerning at least 5 percent of the 

number of skilled nursing facilities 

surveyed by the State in the year, but in 

no case less than 5 skilled nursing 

facilities. . . .’’ Even though AOs are 

not currently included in the CMS 

SPSS, we expect that a similar 

methodology would be applied to all 

hospice surveying entities, including 

AOs with an approved hospice program. 

Just as CMS monitors disparate results 

across States in their adherence to 

Federal processes for determining 

deficiencies, investigating, and 

reporting complaints, it requires States 

to monitor the quality of its surveyors’ 

survey activity and actions. Performance 

measures are applied to all surveying 

entities to assess consistency. If CMS 

finds that surveying entities—SAs and 

AOs—do not meet the performance 

standards, they must develop and 

implement a corrective action plan. 

The SPSS, established annually, 

provides for oversight of SA 

performance when conducting surveys 

to ensure that Medicare and Medicaid 

certified providers and suppliers are 

compliant with Federal CoPs, to 

improve and protect the health and 

safety of Americans. This oversight 

allows CMS to determine that surveyors 

are thorough, accurate, and consistent 

when they determine if a hospice 

program provider is complying with the 

Medicare CoPs. Survey findings with 

respect to a hospice program can 

include: (1) Standard level deficiency— 

where the hospice program is not 

complying fully with CoPs, which need 

corrective action; (2) condition-level 

deficiencies—which require 

remediation and could lead to 

termination of the hospice program; or, 

(3) immediate jeopardy (IJ) level—where 

beneficiaries are present in situations 

where significant harm could occur and 

which need to be addressed without 

delay. SA supervisors are responsible to 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35974 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

ensure that surveyors ‘findings (from 

observations, interviews, and document 

reviews) are consistent with their 

determination of IJ, and standard- or 

condition-level deficiency where a 

hospice program is not compliant with 

a condition of participation. 

To reduce inconsistencies in survey 

results among surveyors, CMS proposes 

to require agencies that review other 

entities’ survey findings for missed 

condition-level deficiency citations 

(disparities) (SAs for AOs, and CMS 

SOG locations for SAs), to notify each 

survey entity of its disparity rate 

annually, and to require a formal 

corrective plan as part of the survey 

entity’s (SA or AO) Quality Assurance 

program. A disparity rate above 10 

percent in 2 consecutive cycles would 

trigger remedial activity such as 

implementing corrective action through 

education, mentoring, or other processes 

to align surveyors’ actions, and 

determinations of deficiencies with 

regulatory requirements. 

g. Special Focus Program (SFP) 

(§ 488.1130) 

Section 1822(b) of the Act requires the 

Secretary to conduct a Special Focus 

Program for hospice programs that the 

Secretary has identified as having 

substantially failed to meet applicable 

requirements of the Act. We propose at 

§ 488.1130 to develop a hospice Special 

Focus Program (SFP) to address issues 

that place hospice beneficiaries at risk 

for poor quality of care through 

increased oversight, and/or technical 

assistance. We propose that specific 

criteria would be used to determine 

whether a hospice program participates 

in the SFP. The proposed criteria are as 

follows: a history of condition-level 

deficiencies on two consecutive 

standard surveys, two consecutive 

substantiated complaint surveys, or two 

or more condition-level deficiencies on 

a single validation survey (the 

validation survey with condition-level 

deficiencies would be in addition to a 

previous recertification or complaint 

survey with condition-level 

deficiencies). A subset of hospice 

programs that meet the proposed criteria 

would be selected to be in the SFP, and 

those hospice programs would be 

surveyed every 6 months, which may 

result in additional enforcement 

remedies and/or termination. CMS uses 

a similar program with long-term care 

facilities and has outlined the following 

protocol for a hospice SFP: 

• The SA and CMS SOG location 

would receive a list from CMS of all 

hospice programs that meet the 

established criteria at § 488.1130(b) for 

placement in the SFP (Candidate List). 

The SA would work with the CMS SOG 

location to select hospice programs from 

the list provided by CMS that would be 

selected for the SFP based on State 

priorities. In the event that no hospice 

programs in a State meet the established 

criteria, then the State SA would not 

have a hospice program in the SFP at 

that time. 

• While a hospice program is in the 

SFP, the SA would survey the facility at 

least once every 6 months, as required 

by the CAA 2021, and may include 

progressively stronger enforcement 

actions in the event of a hospice 

program’s continued failure to meet the 

requirements for participation with the 

Medicare and Medicaid programs. 

• Once an SFP hospice program has 

completed 2 consecutive 6-month SFP 

surveys with no condition-level 

deficiencies cited, the facility would 

graduate from the SFP. If the hospice 

program did not meet the requirements 

to graduate, it would be placed on a 

termination track. 

We seek public comment regarding 

the SFP, specifically the following 

issues: 

• Should CMS utilize a similar 

criteria/process/frame work for the SFP 

as outlined in the current Long-Term 

Care Program. What if any differences 

should CMS considered to enhance the 

overall impact of the hospice SFP. 

• Additional selection criteria that 

CMS should consider for the 

identification and participation in the 

SFP. This may include use of current or 

future data elements that could be 

incorporated into a more comprehensive 

algorithm. 

• Utilization of a Technical Expert 

Panel (TEP) to enhance the SFP in terms 

of selection, enforcement and technical 

assistance criteria while in the program. 

Furthermore, a TEP may assist CMS by 

assisting in identifying contextual data 

and relevant information to assist the 

public in obtaining a more 

comprehensive understanding of the 

Form CMS–2567 survey data and the 

overall performance of a hospice 

provider, in addition to what data to 

include, how to make this information 

useful and meaningful on a CMS 

website. 

4. Proposed New Subpart N— 

Enforcement Remedies for Hospice 

Programs With Deficiencies 

a. Statutory Basis (§ 488.1200) 

We propose to set out the statutory 

basis for the proposed new subpart at 

§ 488.1200, which is new sections 

1822(c)(1) through 1822(c)(5) of the Act. 

The requirements under this new 

subpart would expand the Secretary’s 

options to impose additional 

enforcement remedies for hospice 

programs failing to meet Federal 

requirements. These additional 

enforcement remedies may be used to 

encourage poor-performing hospice 

programs to come into substantial 

compliance with CMS requirements 

before CMS is forced to terminate the 

hospice program’s provider agreement. 

This process is currently afforded to 

HHAs at § 488.745. 

Prior to the enactment of section 

1822(c)(5)(A) of the Act, the only 

enforcement action available to CMS to 

address hospice programs that are 

determined to be out of compliance 

with Federal requirements was the 

termination of their Medicare provider 

agreement. In accordance with section 

1866(b)(2) of the Act and § 489.53(a)(3), 

CMS may terminate a hospice program 

provider agreement if that hospice 

program is not in substantial 

compliance with the Medicare 

requirements (that is, the failure to meet 

one or more CoPs is considered to be a 

lack of substantial compliance). 

b. Definitions (§ 488.1205) 

We propose to add § 488.1205 to 

define the terms ‘‘directed plan of 

correction,’’ ‘‘immediate jeopardy,’’ 

‘‘new admission,’’ ‘‘per instance,’’ ‘‘plan 

of correction,’’ ‘‘repeat deficiency,’’ and 

‘‘temporary management.’’ Although 

section 1891 of the Act uses the term 

‘‘intermediate sanctions,’’ with respect 

to HHA enforcement, and other rules 

use ‘‘alternative sanctions,’’ we propose 

to use ‘‘remedies’’ or ‘‘enforcement 

remedies,’’ which we consider to have 

the same meaning and are closer to the 

language in section 1822 of the Act. 

c. General Provisions (§ 488.1210) 

We propose at § 488.1210 general 

rules pertaining to enforcement actions 

against a hospice program that is not in 

substantial compliance with the CoPs. 

Under section 1822(c)(1) of the Act, if 

CMS determines that a hospice program 

is not in compliance with the Medicare 

hospice programs CoPs and the 

deficiencies involved may immediately 

jeopardize the health and safety of the 

individual(s) to whom the hospice 

program furnishes items and services, 

then we may terminate the hospice 

program’s provider agreement, impose 

the one or more enforcement remedies 

described in section 1822(c)(5)(B) of the 

Act, or both. Our decision to impose one 

or more remedies, including 

termination, will be based on the degree 

of noncompliance with the hospice 

program Federal requirements. With the 

proposed provisions, CMS would be 

able to impose one or more remedies for 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35975 

each discrete condition-level deficiency 

constituting noncompliance. 

It is also important to note that 

hospice programs can acquire initial 

certification for participation in 

Medicare via an SA survey or via 

accreditation by a CMS-approved AO. 

Accreditation by a CMS-approved AO is 

voluntary and not necessary to 

participate in the Medicare program. If 

an AO finds deficiencies during an 

accreditation survey, it communicates 

any condition-level findings to the 

applicable CMS SOG location. Based on 

the survey findings, CMS makes any 

determinations regarding the imposition 

of Federal enforcement remedies. An 

AO cannot recommend or implement 

enforcement remedies. In accordance 

with SOM Chapter 2, section 2005B, 

CMS may temporarily remove deemed 

status of an accredited hospice program 

due to condition-level findings found by 

the SA or Federal survey team during a 

complaint or validation survey. If the 

deficiencies remain uncorrected, 

oversight of that hospice program is 

transferred to CMS, through the SA, 

until the hospice program either 

demonstrates substantial compliance or 

CMS terminates its Medicare 

participation. In such a case where 

‘‘deemed status’’ is removed, CMS will 

follow the usual procedures for 

oversight, as indicated in sections 3254 

and 5100 of the SOM. Once an 

enforcement remedy is imposed on a 

formerly accredited hospice program 

and deemed status is removed, oversight 

and enforcement of that hospice 

program will be performed by the SA 

until the hospice program achieves 

compliance and the condition(s) causing 

the noncompliance are removed or until 

the hospice program is terminated from 

the Medicare program. 

At proposed § 488.1210(e), a hospice 

program would be required to submit an 

acceptable POC to the SA or CMS 

within 10 calendar days from receipt of 

the statement of deficiencies. This plan 

is the hospice program’s written 

response to survey findings detailing 

corrective actions to cited deficiencies 

and the date by which those 

deficiencies will be corrected. CMS 

would determine if the POC was 

acceptable based on the information 

presented. 

At proposed § 488.1210(e), we 

propose the notification requirements 

for enforcement remedies for hospice 

programs that will be issued by CMS. 

CMS will provide a notice of intent to 

the hospice program that would include 

the intent to impose a remedy, the 

statutory basis for the remedy, the 

nature of the noncompliance, the intent 

to impose a payment suspension and 

which payments would be suspended (if 

applicable), the intent to propose a CMP 

and the amount being imposed (if 

applicable), the proposed effective date 

of the sanction, and appeal rights. 

We propose that for all remedies 

imposed, except for CMPs, when there 

is IJ the notice period is at least 2 

calendar days before the effective date 

of the enforcement action and when 

there is no IJ, that the notice period is 

at least 15 calendar days before the 

effective date of the enforcement action. 

As discussed later in this section, we 

propose to codify these proposals at 

§§ 488.1225(b) and 488.1230(b), 

respectively. 

With respect to CMPs, we propose 

that once the administrative 

determination to impose the CMP is 

final, CMS would send a final notice to 

the hospice program with the amount of 

the penalty assessed, the total number of 

days of noncompliance (for CMPs 

imposed per day), the total amount due, 

the due date of the penalty, and the rate 

of interest to be charged on unpaid 

balances. We propose to codify these 

proposals at § 488.1245(e). 

We propose that the hospice program 

could appeal the determination of 

noncompliance leading to the 

imposition of a remedy under the 

provisions of 42 CFR part 498. A 

pending hearing would not delay the 

effective date of the remedy against the 

hospice program and remedies will be 

in effect regardless of any pending 

appeals proceedings. Civil money 

penalties would accrue during the 

pendency of an appeal, but would not 

be collected until the administrative 

determination is final, as we note in 

proposed § 488.1245(f). 

d. Factors To Be Considered in Selecting 

Remedies (§ 488.1215) 

Section 1822(c) of the Act provides 

that if a hospice program is found to be 

out of compliance with the 

requirements specified in section 

1861(dd) of the Act, CMS may impose 

one or more specified enforcement 

remedies. In this proposed rule, we have 

proposed to establish requirements for 

enforcement remedies that may be 

imposed when hospice programs are out 

of compliance with Federal 

requirements. At CMS’ discretion, these 

enforcement remedies can be imposed 

instead of, or in addition to, termination 

of the hospice program’s participation 

in the Medicare program, for a period 

not to exceed 6 months. The choice of 

any enforcement remedy or termination 

would reflect the impact on patient care 

and the seriousness of the hospice 

program’s patterns of noncompliance 

and would be based on the factors 

proposed in § 488.1215. CMS may 

impose termination of the provider 

agreement (that is, begin termination 

proceedings that would become 

effective at a future date, but no later 

than 6 months from the determination 

of noncompliance), and impose one or 

more remedies for hospice programs 

with the most egregious deficiencies, on 

a hospice program that was unwilling or 

unable to achieve compliance within 

the maximum timeframe of 6 months, 

whether or not the violations 

constituted an IJ situation. We propose 

at § 488.1215, consistent with section 

1822(5)(B)(i) of the Act, to establish 

procedures for selecting the appropriate 

enforcement remedy, including the 

amount of any CMP and the severity of 

each remedy, which have been designed 

to minimize the time between the 

identification of deficiencies and the 

final imposition of remedies, as required 

under section 1822(c)(5)(A)(ii) of the 

Act. To determine which remedy or 

remedies to apply, CMS proposes to 

consider the following factors that are 

consistent with the factors for HHA 

alternative sanctions: 

• The extent to which the 

deficiencies pose IJ to patient health and 

safety. 

• The nature, incidence, manner, 

degree, and duration of the deficiencies 

or noncompliance. 

• The presence of repeat deficiencies 

(defined as condition-level), the hospice 

program’s compliance history in 

general, and specifically concerning the 

cited deficiencies, and any history of 

repeat deficiencies at any of the hospice 

program’s additional locations. 

• The extent to which the 

deficiencies are directly related to a 

failure to provide quality patient care. 

• The extent to which the hospice 

program is part of a larger organization 

with documented performance 

problems. 

• Whether the deficiencies indicate a 

system-wide failure of providing quality 

care. 

e. Available Remedies (§ 488.1220) 

Section 1822(c)(5)(A)(ii) of the Act 

provides that CMS ‘‘shall develop and 

implement specific procedures for the 

conditions under which each of the 

remedies developed under clause (i) is 

to be applied, including the amount of 

any fines and the severity of each of 

these remedies.’’ Section 1822(c)(5)(B) 

of the Act explicitly provides for the 

following enforcement remedies to be 

included in the range of remedies: (1) 

CMPs in an amount not to exceed 

$10,000 for each day of noncompliance 

by a hospice program with the 

requirements specified in section 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35976 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

1861(dd) of the Act; (2) suspension of 

all or part of the payments to which a 

hospice program would otherwise be 

entitled under this title for items and 

services furnished by a hospice 

program, on or after the date on which 

the Secretary determines that remedies 

should be imposed; and (3) appointment 

of temporary management to oversee the 

operation of the hospice program and to 

protect and assure the health and safety 

of the individuals under the care of the 

program while improvements are made 

to bring the program into compliance 

with all such requirements. In addition 

to those specified in the statute, we 

propose to add a directed POC and 

directed in-service training as additional 

enforcement remedies at § 488.1220. 

f. Action When Deficiencies Pose 

Immediate Jeopardy (§ 488.1225) and 

Termination (§ 489.53) 

For situations involving IJ, if CMS 

determines based on a standard survey 

or otherwise that a hospice program’s 

deficiencies involve IJ to the health and 

safety of the individuals to whom the 

program furnishes items and services, it 

shall take immediate action to ensure 

the removal of the IJ and to correct the 

deficiencies or terminate the 

certification of the program. We are 

proposing at § 488.1225(a) to implement 

the statutory requirement of 1822(c)(1) 

of the Act by specifying that if the IJ 

situation is not addressed and resolved 

within 23 days from the last day of the 

survey because the hospice program is 

unable or unwilling to correct the 

deficiencies, CMS will terminate the 

hospice program’s provider agreement. 

In addition, CMS could impose one or 

more enforcement remedies including a 

CMP, temporary management, and/or 

suspension of all or part of Medicare 

payments before the effective date of 

termination. 

We propose § 488.1225(b), that for a 

deficiency or deficiencies that pose IJ, 

CMS would provide the hospice 

program with at least 2 days advance 

notice of any proposed remedies, except 

CMPs (discussed at proposed 

§ 488.1245). The requirements for a 

notice of intent are set forth at proposed 

§ 488.1210(e). Under our existing survey 

process, providers are informed of any 

IJ findings upon discovery of the IJ 

situation during the survey or as part of 

the exit conference at the end of the 

survey. This would give a hospice 

program time to remove the IJ and 

correct the deficiencies that gave rise to 

the IJ finding. To assure a hospice 

program achieves prompt compliance, 

we expect that CMS will give hospice 

programs written notice of an 

impending enforcement actions against 

them as quickly as possible following 

the completion of a survey of any kind. 

For terminations, CMS will give 

notice of the termination within 2 days 

before the effective date of the 

termination, to hospice programs 

consistent with the requirement for 

HHAs. We also propose to amend 

§ 489.53(a)(17) to indicate that we will 

terminate a hospice program’s (as well 

as an HHA’s) provider agreement if the 

hospice program failed to correct a 

deficiency or deficiencies within the 

required time frame. 

Finally, at proposed § 488.1225(c), we 

propose to require a hospice program 

whose provider agreement is terminated 

to appropriately and safely transfer its 

patients to another local hospice 

program within 30 days of termination, 

unless a patient or caregiver chooses to 

remain with the hospice program as a 

self-pay or with another form of 

insurance (for example, private 

insurance). In addition, the hospice 

program would be responsible for 

providing information, assistance, and 

any arrangements necessary for the safe 

and orderly transfer of its patients. 

g. Action When Deficiencies Are at the 

Condition-Level But Do Not Pose 

Immediate Jeopardy (§ 488.1230) 

In section 1822(c)(2) of the Act, if the 

Secretary determines based on a survey 

or otherwise that a hospice program is 

no longer in compliance with the 

requirements specified in section 

1861(dd) of the Act and determines that 

the deficiencies involved do not 

immediately jeopardize the health and 

safety of the individuals to whom the 

program furnishes items and services, 

the Secretary may (for a period not to 

exceed 6 months) impose remedies 

developed under section 1822(c)(5)(A) 

of the Act, in lieu of terminating hospice 

program’s participation in the Medicare 

program. If, after such a period of 

remedies, the program is still not in 

compliance with all requirements, the 

Secretary shall terminate the hospice 

program’s participation in the Medicare 

program. 

In this proposed rule, enforcement 

remedies, such as those proposed in 

§ 488.1220, would be imposed before 

the termination becomes effective, but 

cannot continue for a period that 

exceeded 6 months. In addition, to 

protect the health and safety of 

individuals receiving services from the 

hospice program, enforcement remedies 

would continue in effect until the 

hospice program achieves compliance 

or has its Medicare participation 

terminated, whichever occurs earlier. 

For example, the suspension of payment 

remedy will end when the hospice 

program corrects all condition-level 

deficiencies or is terminated from the 

Medicare program. 

We propose at § 488.1230, that for a 

deficiency or deficiencies that do not 

pose IJ, CMS will provide the hospice 

program at least 15 days advance notice 

of any proposed remedies, except for 

CMPs (discussed at proposed 

§ 488.1245). Such remedies would 

remain in effect until the effective date 

of an impending termination (at 6 

months) or until the hospice program 

achieves compliance with CoPs, 

whichever is earlier. This 15-day period 

is consistent with the general rule for 

providers and suppliers in 

§ 489.53(d)(1). 

h. Temporary Management (§ 488.1235) 

Section 1822(c)(5)(B)(iii) of the Act 

specifies the use of appointment of 

temporary management, as an 

enforcement remedy, to oversee the 

operation of the hospice program and to 

protect and assure the health and safety 

of the individuals under the care of the 

program while improvements are made 

in order to bring the program into 

compliance with all such requirements. 

As we propose at § 488.1205, 

‘‘temporary management’’ means the 

temporary appointment by CMS or a 

CMS authorized agent, of a substitute 

manager or administrator, who would 

be under the direction of the hospice 

program’s governing body and who 

would have authority to hire, terminate 

or reassign staff, obligate hospice 

program funds, alter hospice program 

procedures, and manage the hospice 

program to correct deficiencies 

identified in the hospice program’s 

operation. The substitute manager or 

administrator would be appointed based 

on qualifications described in § 418.100 

and § 418.114 and would be under the 

direction of the hospice program’s 

governing body. 

We propose at § 488.1235 to set out 

the circumstances under which we 

would utilize our authority under 

section 1822(c)(5)(C)(iii) of the Act to 

place a hospice program under 

temporary management. We propose to 

specify the duration and effect of this 

enforcement remedy, and the payment 

procedures for temporary managers’ 

salaries and other additional costs. CMS 

would provide the hospice program 

with written notice of our intent to 

impose a temporary management 

remedy in accordance with proposed 

§ 488.1210(e). 

At § 488.1235(a), we propose that 

temporary management would be 

imposed when a hospice program is 

determined to have condition-level 

deficiencies and that the deficiencies or 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35977 

the management limitations of the 

hospice program are likely to impair the 

hospice program’s ability to correct the 

deficiencies and return the hospice 

program to compliance with all of the 

CoPs within the required timeframe. We 

propose at § 488.1235(c) to impose 

temporary management to bring a 

hospice program into compliance with 

program requirements within 6 months 

of the date of the survey identifying 

noncompliance. 

We propose at § 488.1235(b) if the 

hospice program refuses to relinquish 

authority and control to the temporary 

manager, CMS will terminate the 

hospice program’s provider agreement. 

If a temporary manager was appointed, 

but the hospice program failed to correct 

the condition-level deficiencies within 6 

months from the last day of the survey, 

the hospice program’s Medicare 

participation would be terminated. 

Additionally, if the hospice program 

resumes management control without 

CMS’s approval, we would impose 

termination and could impose 

additional enforcement remedies. The 

appointment of a temporary manager 

would not relieve the hospice program 

of its responsibility to achieve and 

maintain compliance with the 

participation requirements. We propose 

at § 488.1235 that temporary 

management would end when— 

• We determine that the hospice 

program has achieved substantial 

compliance and has the management 

capability to remain in compliance; 

• The hospice program provider 

agreement is terminated; or 

• The hospice program resumes 

management control without CMS 

approval. 

• Temporary management will not 

exceed a period of 6 months from the 

date of the survey identifying 

noncompliance. 

At § 488.1235, we propose that 

temporary management would be 

required to be provided at the hospice 

program’s expense. Before the 

temporary manager was installed, the 

hospice program would have to agree to 

pay his/her salary directly for the 

duration of the appointment. We believe 

that the responsibility for the hospice 

program to pay the expenses of the 

temporary manager is an inherent 

management responsibility of the 

hospice agency for which Medicare 

regularly reimburses the hospice 

program and through such temporary 

outside management might be necessary 

in some cases to bring the hospice 

program back into compliance with the 

CoPs. We are proposing that the salary 

for the temporary manager would not be 

less than the amount equivalent to the 

prevailing salary paid by providers in 

the geographic area for positions of this 

type, based on the Bureau of Labor 

Statistics, National Occupational 

Employment and Wage Estimates. In 

addition, the hospice program would 

have to pay for any additional costs that 

the hospice program may have incurred 

if such person had been in an 

employment relationship, and any other 

costs incurred by such a person in 

furnishing services under such an 

arrangement or as otherwise set by the 

State. CMS would consider a hospice 

program’s failure to pay the salary of the 

temporary manager to be a failure to 

relinquish authority and control to 

temporary management. 

i. Suspension of Payment for All or Part 

of the Payments (§ 488.1240) 

We propose in § 488.1240 provisions 

describing when and how we would 

apply a suspension of payment of all or 

part of the payments for items and 

services furnished by a hospice program 

on or after the date on which the 

Secretary determines that remedies 

should be imposed under § 488.1225 or 

§ 488.1230. If a hospice program has a 

condition-level deficiency or 

deficiencies (regardless of whether or 

not an IJ exists), we may suspend 

payments for all or part of the payments 

to which a hospice program would 

otherwise be entitled for items and 

services furnished by a hospice program 

on or after the effective date of the 

enforcement remedy. CMS will 

determine whether to impose a 

suspension of all or part of the 

payments based on the factors outlined 

in proposed § 488.1215 that are 

considered when selecting remedies. 

The suspension of payment is proposed 

at § 488.1240 to be for a period not 

exceed 6 months and would end when 

the hospice program either achieved 

substantial compliance or was 

terminated. CMS would provide the 

hospice program with written notice of 

our intent to impose a payment 

suspension remedy at least 2 calendar 

days before the effective date of the 

remedy in IJ situations, per proposed 

§ 488.1225(b), or 15 calendar days 

before the effective date of the remedy 

in non-IJ situations, per proposed 

§ 488.1230(b). The proposed notice of 

intent for all remedies, described at 

§ 488.1210(e), would be used to notify a 

hospice program of a suspension of 

payment of all or part of the payments 

to which the hospice program would 

otherwise be entitled. 

Additionally, section 1822(c)(5)(C)(ii) 

of the Act provides that a suspension of 

payment remedy shall terminate when 

CMS finds that the hospice program is 

in substantial compliance with the 

requirements specified in, or developed 

in accordance with, section 1861(dd) of 

the Act. That is, the suspension of 

payment remedy will end when the 

hospice program is determined to have 

corrected all condition-level 

deficiencies, or upon termination, 

whichever is earlier. We propose to 

codify that duration of the remedy at 

488.1240(c). 

j. CMPs (§ 488.1245) 

We propose at § 488.1245 

requirements for the imposition of 

CMPs. Section 1822(c)(5)(C) of the Act 

outlines the requirements for CMP 

procedures. Additionally, section 

1822(c)(5)(C)(i)(I) of the Act requires 

that the CMP provisions under section 

1128A (other than subsections (a) and 

(b) of the Act shall be applied to the 

hospice CMPs, which also must be 

considered when establishing the 

amount. CMS proposes to impose a 

CMP against a hospice program that is 

determined to be out of compliance 

with one or more CoPs, regardless of 

whether the hospice program’s 

deficiencies pose IJ to patient health and 

safety. CMS could also impose a CMP 

for the number of days of IJ. Under 

section 1822(c)(5)(B)(i) of the Act, the 

CMP amount cannot exceed $10,000 for 

each day of noncompliance. Our 

proposals align with the imposition of 

CMPs authorized by section 1891(f) of 

the Act as set out for HHAs at § 488.845, 

which CMS may impose against an 

HHA that is determined to be out of 

compliance with one or more CoPs, 

regardless of whether the HHA’s 

deficiencies pose IJ to patient health and 

safety. 

In this section, we are proposing both 

‘‘per day’’ and ‘‘per instance’’ CMPs at 

§ 488.1245(a). The per day CMPs would 

be imposed for each day of 

noncompliance with the CoPs. 

Additionally, should a survey identify a 

particular instance or instances of 

noncompliance during a survey, we 

propose to impose a CMP for that 

instance or those individual instances of 

noncompliance. We propose to define 

‘‘per instance’’ in § 488.1205 as a single 

event of noncompliance identified and 

corrected during a survey, for which the 

statute authorizes CMS to impose a 

remedy. 

While there may be a single event that 

leads to noncompliance, there can also 

be more than one instance of 

noncompliance identified and more 

than one CMP imposed during a survey. 

For penalties imposed per instance of 

noncompliance, we are proposing 

penalties from $1,000 to $10,000 per 

instance. Such penalties would be 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35978 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

assessed for one or more singular events 

of condition-level noncompliance that 

were identified at the survey and where 

the noncompliance was corrected 

during the onsite survey. 

Since the range of possible 

deficiencies is great and depends upon 

the specific circumstances at a 

particular time, it would be impossible 

to assign a specific monetary amount for 

each type of noncompliance that could 

be found. Thus, we believe that each 

deficiency would fit into a range of CMP 

amounts. 

We are proposing that, in addition to 

those factors that we would consider 

when choosing a type of remedy 

proposed in § 488.1215, we would 

consider the following factors when 

determining a CMP amount: 

• The size of the hospice program and 

its resources. 

• Evidence that the hospice program 

has a built-in, self-regulating quality 

assessment and performance 

improvement system to provide proper 

care, prevent poor outcomes, control 

patient injury, enhance quality, promote 

safety, and avoid risks to patients on a 

sustainable basis that indicates the 

ability to meet the CoPs and to ensure 

patient health and safety. When several 

instances of noncompliance would be 

identified at a survey, more than one 

per-day or per instance CMP could be 

imposed as long as the total CMP did 

not exceed $10,000 per day. In addition, 

a per-day and a per-instance CMP 

would not be imposed simultaneously 

for the same deficiency in conjunction 

with a survey. 

At proposed § 488.1245, CMS would 

have the discretion to increase or reduce 

the amount of the CMP during the 

period of noncompliance, depending on 

whether the level of noncompliance had 

changed at the time of a revisit survey. 

However, section 1822(c)(5)(B)(i) of the 

Act specifies that the remedies shall 

include a CMP in an amount not to 

exceed $10,000 for each day of 

noncompliance. Therefore, we are 

proposing at § 488.1245(b)(2)(iii) that no 

CMP assessment could exceed $10,000 

per day of noncompliance. To comply 

with sections 1822(c)(5)(B)(i) and 

1822(c)(5)(C)(i) of the Act, we propose 

to establish a three-tier system with 

subcategories that would establish the 

amount of a CMP. 

In proposed § 488.1245(b)(3), (b)(4), 

and (b)(5), we propose ranges of CMP 

amounts based on three levels of 

seriousness—upper, middle, and lower: 

• Upper range—For a deficiency that 

poses IJ to patient health and safety, we 

would assess a penalty within the range 

of $8,500 to $10,000 per day of 

condition-level noncompliance. 

• Middle range—For repeat and/or a 

condition-level deficiency that did not 

pose IJ, but is directly related to poor 

quality patient care outcomes, we would 

assess a penalty within the range of 

$1,500 up to $8,500 per day of 

noncompliance with the CoPs. 

• Lower range—For repeated and/or 

condition-level deficiencies that did not 

constitute IJ and were deficiencies in 

structures or processes that did not 

directly relate to poor quality patient 

care, we would assess a penalty within 

the range of $500 to $4,000 per day of 

noncompliance. 

The proposed CMP amounts would be 

subject to annual adjustments for 

inflation in accordance with the Federal 

Civil Monetary Penalty Inflation 

Adjustment Act of 1990 (Pub. L. 101– 

140), as amended by the Federal Civil 

Penalties Inflation Adjustment Act 

Improvements Act of 2015 (section 701 

of Pub. L. 114–74). Annually adjusted 

amounts are published at 45 CFR part 

102. 

Under the proposed provisions, if 

CMS imposed a CMP, CMS would send 

the hospice program written notification 

of the intent to impose it, including the 

amount of the CMP being imposed and 

the proposed effective date of the 

sanction, under proposed §§ 488.1210(e) 

and 488.1245(c). Once the 

administrative determination is final, 

we propose to send a final notice to the 

hospice program with the amount of the 

penalty that was assessed; the total 

number of days of noncompliance (for 

per day CMPs); the total amount due; 

the due date of the penalty; and the rate 

of interest to be charged on unpaid 

balances. 

Whether per instance or per day 

CMPs are imposed, once the hospice 

program has received the notice of 

intent to impose the CMP, it would have 

60 calendar days from the receipt of the 

written notice of intent to either request 

an administrative hearing in accordance 

with § 498.40 or to provide notice to 

CMS of its intent to waive its right to an 

administrative hearing, in accordance to 

the procedures specified in proposed 

§ 488.1245(c)(2), to receive a 35 percent 

reduction in the CMP amount. The CMP 

would be due within 15 calendar days 

of hospice programs’ written request for 

waiver. If the hospice program did not 

respond to the notice of intent to impose 

a CMP within 60 calendar days of 

receipt, it would waive its right to a 

hearing. In such cases, the CMP would 

not be reduced by 35 percent because a 

hospice program must follow the 

procedures specified at proposed 

§ 488.1245(c)(2) to receive the 

reduction. 

A per-day CMP would begin to accrue 

as early as the beginning of the last day 

of the survey that determines that the 

hospice program was out of compliance 

and would end on the date of correction 

of all deficiencies, or the date of 

termination. We propose at 

§ 488.1245(d) that in IJ cases, if the IJ is 

not removed, the CMP would continue 

to accrue until CMS terminated the 

provider agreement (within 23 calendar 

days after the last day of the survey 

which first identified the IJ). Under 

proposed § 488.1245(d)(4), if IJ did not 

exist, the CMP would continue to accrue 

until the hospice program achieved 

substantial compliance or until CMS 

terminated the provider agreement. 

As noted elsewhere, in no instance 

would a period of noncompliance be 

allowed to extend beyond 6 months 

from the last day of the survey that 

initially determined noncompliance. If 

the hospice program has not achieved 

compliance with the CoPs within those 

6 months, we would terminate the 

hospice program. The accrual of per-day 

CMPs would stop on the day the 

hospice program provider agreement 

was terminated or the hospice program 

achieved substantial compliance, 

whichever was earlier. The total CMP 

amounts would be computed and 

collected after an administrative 

determination is final and a final notice 

sent to the hospice program as described 

in § 488.1245(e). 

We also propose that for a hospice 

program being involuntarily terminated 

and for which a civil money penalty had 

been imposed and was still due, we 

would include the final notice, also 

known as a due and payable notice, as 

part of the termination notice. In other 

words, the information in a final notice, 

as described in § 488.1245(e), would be 

included in the termination notice. 

At proposed § 488.1245(f), a CMP 

would become due and payable 15 

calendar days from— 

• The time to appeal had expired 

without the hospice program appealing 

its initial determination; 

• CMS received a request from the 

hospice program waiving its right to 

appeal the initial determination; 

• A final decision of an 

Administrative Law Judge or Appellate 

Board of the Departmental Appeals 

Board upheld CMS’s determinations; or 

• The hospice program was 

terminated from the program and no 

appeal request was received. 

A request for a hearing would not 

delay the imposition of the CMP, but 

would only affect the collection of any 

final amounts due to CMS. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35979 

k. Directed Plan of Correction 

(§ 488.1250) 

We propose at § 488.1250 to include 

a directed plan of correction as an 

available remedy. This remedy is a part 

of the current HHA and nursing home 

alternative sanction procedures and has 

been an effective tool to encourage 

correction of deficient practices. 

Specifically, we propose that CMS may 

impose a directed POC on a hospice 

program that is out of compliance with 

the CoPs. A directed POC remedy would 

require the hospice program to take 

specific actions to bring the hospice 

program back into compliance and 

correct the deficient practice(s). As 

indicated in § 488.1250(b)(2) a hospice 

program’s directed POC would be 

developed by CMS or by the temporary 

manager, with CMS approval. The 

directed POC would set forth the 

outcomes to be achieved, the corrective 

action necessary to achieve these 

outcomes and the specific date the 

hospice program would be expected to 

achieve such outcomes. The hospice 

program would be responsible for 

achieving compliance. If the hospice 

program failed to achieve compliance 

within the timeframes specified in the 

directed POC, CMS could impose one or 

more additional enforcement remedies 

until the hospice program achieved 

compliance or was terminated from the 

Medicare program. Before imposing this 

remedy, CMS would provide 

appropriate notice to the hospice 

program under § 488.1210(e). 

l. Directed In-Service Training 

(§ 488.1255) 

We propose at § 488.1255, to outline 

the requirements for conducting 

directed in-service training for hospice 

programs with condition-level 

deficiencies. At proposed § 488.1255(a), 

directed in-service training would be 

required where staff performance 

resulted in noncompliance and it was 

determined that a directed in-service 

training program would correct this 

deficient practice through retraining the 

staff in the use of clinically and 

professionally sound methods to 

produce quality outcomes. 

At § 488.1255(a)(3), we are proposing 

that hospice programs use in-service 

programs conducted by instructors with 

an in-depth knowledge of the area(s) 

that would require specific training, so 

that positive changes would be achieved 

and maintained. Hospice programs 

would be required to participate in 

programs developed by well-established 

education and training services. These 

programs would include, but not be 

limited to, schools of medicine or 

nursing, area health education centers, 

and centers for aging. CMS will only 

recommend possible training locations 

to a hospice program and not require 

that the hospice program utilize a 

specific school/center/provider. In 

circumstances where the hospice is 

subject to the SFP, additional technical 

assistance and/or resources could be 

made available. The hospice program 

would be responsible for payment for 

the directed in-service training for its 

staff. At proposed § 488.1255(b), if the 

hospice program did not achieve 

substantial compliance after such 

training, CMS could impose one or more 

additional remedies. Before imposing 

this remedy, CMS would provide 

appropriate notice to the hospice 

program under proposed § 488.1210(e). 

m. Continuation of Payments to a 

Hospice Program With Deficiencies 

(§ 488.1260) 

We propose at § 488.1260, the 

continuation of Medicare payments to 

hospice programs not in compliance 

with the requirements specified in 

section 1861(dd) of the Act over a 

period of no longer than 6 months in 

accordance with section 1822(c)(4) of 

the Act. The continuation of Medicare 

payments will continue for 6 months 

if— 

• An enforcement remedy or 

remedies (with the exception of 

suspension of all payments) have been 

imposed on the hospice program and 

termination has not been imposed; 

• The hospice program has submitted 

a POC which has been approved by 

CMS; and 

• The hospice program agrees to 

repay the Federal government the 

payments received under this 

arrangement should the hospice 

program fail to take the corrective action 

as outlined in its approved POC in 

accordance with the approved plan and 

timetable for corrective action. 

We propose these three criteria at 

§ 488.1260(a). If any of these three 

requirements outlined in the Act were 

not met, a hospice program would not 

receive any Federal payments from the 

time that deficiencies were initially 

identified. CMS would also terminate 

the agreement before the end of the 6- 

month correction period, which begins 

on the last day of the survey, in 

accordance with § 488.1265 if the 

requirements at § 488.1260(a)(1) were 

not met. If any remedies were also 

imposed, they would stop accruing or 

end when the hospice program achieved 

compliance with all requirements, or 

when the hospice program’s provider 

agreement was terminated, whichever 

was earlier. 

Finally, if a hospice program provided 

an acceptable POC but could not 

achieve compliance with the CoPs upon 

resurvey within 6 months of the last day 

of the survey, we propose at 

§ 488.1230(d) that we would terminate 

the provider agreement. 

n. Termination of Provider Agreement 

(§ 488.1265) 

At § 488.1265(a), we propose to 

address the termination of a hospice 

program’s Medicare provider agreement, 

as well as the effect of such termination. 

Termination of the provider agreement 

would end all payments to the hospice 

program, including any payments that 

were continued at the proposed 

§ 488.1260. Termination would also end 

enforcement remedies imposed against 

the hospice program, regardless of any 

proposed timeframes for the remedies 

originally specified. At proposed 

§ 488.1265(b), CMS would terminate the 

provider agreement if—(1) the hospice 

program failed to correct condition-level 

deficiencies within 6 months unless the 

deficiencies constitute IJ; (2) the hospice 

program failed to submit an acceptable 

POC; (3) the hospice program failed to 

relinquish control of the temporary 

manager (if that remedy is imposed); or 

(4) the hospice program failed to meet 

the eligibility criteria for continuation of 

payments. At § 488.1265(d) we propose 

using the procedures for terminating a 

hospice program at § 489.53 and 

providing appeal rights in accordance 

with 42 CFR part 489. Additionally, we 

propose using the procedures for 

payments 30 days post termination for 

hospice programs at § 489.55. Payment 

is available for up to 30 days after the 

effective date of termination for hospice 

care furnished under a plan established 

before the effective date of termination 

(§ 489.55(a)(2)). 

VIII. Requests for Information 

A. Fast Healthcare Interoperability 

Resources (FHIR) in Support of Digital 

Quality Measurement in Post-Acute 

Care Quality Reporting Programs— 

Request for Information 

1. Background 

A goal of the HH QRP is to improve 

the quality of health care for 

beneficiaries through measurement, 

transparency, and public reporting of 

data. The HH QRP contributes to 

improvements in health care, enhancing 

patient outcomes, and informing 

consumer choice. In October 2017, we 

launched the Meaningful Measures 

Framework. This framework captures 

our vision to address health care quality 

priorities and gaps, including 

emphasizing digital quality 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35980 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

95 Definition taken from the CMS Quality 

Conference 2021. 

96 Department of Health and Human Services. 

National Health Quality Roadmap. May 15, 2020. 

Available at: https://www.hhs.gov/sites/default/ 

files/national-health-quality-roadmap.pdf. 

measurement (dQM), reducing 

measurement burden, and promoting 

patient perspectives, while also focusing 

on modernization and innovation. The 

scope of the Meaningful Measures 

Framework has evolved to Meaningful 

Measure 2.0 to accommodate the 

changes in the health care environment, 

initially focusing on measure and 

burden reduction to include the 

promotion of innovation and 

modernization of all aspects of quality, 

t is a need to streamline our approach 

to data collection, calculation, and 

reporting to fully leverage clinical and 

patient-centered information for 

measurement, improvement, and 

learning. 

In alignment with the Meaningful 

Measures 2.0, we are seeking feedback 

on our future plans to define digital 

quality measures for the HH QRP. We 

also are seeking feedback on the 

potential use of Fast Healthcare 

Interoperable Resources (FHIR) for 

dQMs within the HH QRP aligning 

where possible with other quality 

programs. FHIR is an open source 

standards framework (in both 

commercial and government settings) 

created by Health Level Seven 

International (HL7®) that establishes a 

common language and process for all 

health information technology. 

2. Definition of Digital Quality Measures 

We are considering adopting a 

standardized definition of dQMs in 

alignment across the QRPs including the 

HH QRP. We are considering in the 

future to propose the adoption within 

the HH QRP the following definition: 

‘‘Digital Quality Measures’’ (dQMs) are 

quality measures that use one or more 

sources of health information that are 

captured and can be transmitted 

electronically via interoperable 

systems.95 A dQM includes a 

calculation that processes digital data to 

produce a measure score or measure 

scores. Data sources for dQMs may 

include administrative systems, 

electronically submitted clinical 

assessment data, case management 

systems, electronic health records 

(EHRs), instruments (for example, 

medical devices and wearable devices), 

patient portals or applications (for 

example, for collection of patientgenerated health data), health 

information exchanges (HIEs) or 

registries, and other sources. As an 

example, the quality measures 

calculated from patient assessment data 

submitted electronically to CMS would 

be considered digital quality measures. 

3. Use of FHIR for Future dQMs in the 

HH QRP 

Over the past years in other quality 

programs, we have focused on 

opportunities to streamline and 

modernize quality data collection and 

reporting processes, such as exploring 

HL7® FHIR® (http://hl7.org/fhir) for 

other quality programs. One of the first 

areas CMS has identified relative to 

improving our digital strategy is through 

the use of FHIR-based standards to 

exchange clinical information through 

application programming interfaces 

(APIs), allowing clinicians to digitally 

submit quality information one time 

that can then be used in many ways. We 

believe that in the future proposing such 

a standard within the HH QRP could 

potentially enable collaboration and 

information sharing, which is essential 

for delivering high-quality care and 

better outcomes at a lower cost. 

We are currently evaluating the use of 

FHIR based APIs to access assessment 

data collected and maintained through 

the Quality Improvement and 

Evaluation System (QIES) and internet 

QIES (iQIES) health information 

systems and are working with 

healthcare standards organizations to 

assure that their evolving standards 

fully support our assessment instrument 

content. Further, as more Post-Acute 

Care providers, including HHAs, are 

adopting EHRs, we are evaluating using 

the FHIR interfaces for accessing patient 

data (including standard assessments) 

directly from HHA EHRs. Accessing 

data in this manner could also enable 

the exchange of data for purposes 

beyond data reporting to CMS, such as 

care coordination further increasing the 

value of EHR investments across the 

healthcare continuum. Once providers 

map their EHR data to a FHIR API in 

standard FHIR formats it could be 

possible to send and receive the data 

needed for measures and other uses 

from their EHRs through FHIR APIs. 

4. Future Alignment of Measures Across 

Reporting Programs, Federal and State 

Agencies, and the Private Sector 

We are committed to using policy 

levers and working with stakeholders to 

achieve interoperable data exchange and 

to transition to full digital quality 

measurement in our quality reporting 

programs. We are considering the future 

potential development and staged 

implementation of a cohesive portfolio 

of dQMs across our regulated programs, 

including HHQRP, agencies, and private 

payers. This cohesive portfolio would 

require, where possible, alignment of: 

(1) Measure concepts and specifications 

including narrative statements, measure 

logic, and value sets, and (2) the 

individual data elements used to build 

these measure specifications and 

calculate the measures. Further, the 

required data elements would be limited 

to standardized, interoperable elements 

to the fullest extent possible; hence, part 

of the alignment strategy will be the 

consideration and advancement of data 

standards and implementation guides 

for key data elements. We would 

coordinate closely with quality measure 

developers, Federal and State agencies, 

and private payers to develop and 

maintain a cohesive dQM portfolio that 

meets our programmatic requirements 

and that fully aligns across Federal and 

State agencies and payers to the extent 

possible. 

We intend this coordination to be 

ongoing and allow for continuous 

refinement to ensure quality measures 

remain aligned with evolving healthcare 

practices and priorities (for example, 

patient reported outcomes (PROs), 

disparities, care coordination), and track 

with the transformation of data 

collection. This includes conformance 

with standards and health IT module 

updates, future adoption of technologies 

incorporated within the ONC Health IT 

Certification Program and may also 

include standards adopted by ONC (for 

example, standards-based APIs). The 

coordination would build on the 

principles outlined in HHS’ National 

Health Quality Roadmap.96

It would focus on the quality domains 

of safety, timeliness, efficiency, 

effectiveness, equitability, and patientcenteredness. It would leverage several 

existing Federal and public-private 

efforts including our Meaningful 

Measures 2.0 Framework; the Federal 

Electronic Health Record Modernization 

(DoD/VA); the Core Quality Measure 

Collaborative, which convenes 

stakeholders from America’s Health 

Insurance Plans (AHIP), CMS, the 

Consensus-Based Entity under section 

1890 of the Act, provider organizations, 

private payers, and consumers and 

develops consensus on quality measures 

for provider specialties; and the NQFconvened Measure Applications 

Partnership (MAP) which reviews 

measures submitted to the Measures 

Under Consideration (MUC) list and 

makes recommendations on whether or 

not to use them in Medicare programs.’’ 

We would coordinate with HL7’s 

ongoing work to advance FHIR 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35981 

97 Joynt KE, Orav E, Jha AK. Thirty-Day 

Readmission Rates for Medicare Beneficiaries by 

Race and Site of Care. JAMA. 2011; 305(7):675–681. 

98Lindenauer PK, Lagu T, Rothberg MB, et al. 

Income Inequality and 30 Day Outcomes After 

Acute Myocardial Infarction, Heart Failure, and 

Pneumonia: Retrospective Cohort Study. British 

Medical Journal. 2013; 346. 

99Trivedi AN, Nsa W, Hausmann LRM, et al. 

Quality and Equity of Care in U.S. Hospitals. New 

England Journal of Medicine. 2014; 371(24):2298– 

2308. 

100Polyakova, M., et al. Racial Disparities In 

Excess All-Cause Mortality During The Early 

COVID–19 Pandemic Varied Substantially Across 

States. Health Affairs. 2021; 40(2): 307–316. 

101Rural Health Research Gateway. Rural 

Communities: Age, Income, and Health Status. 

Rural Health Research Recap. November 2018. 

102https://www.minorityhealth.hhs.gov/assets/ 

PDF/Update_HHS_Disparities_Dept-FY2020.pdf. 

103www.cdc.gov/mmwr/volumes/70/wr/ 

mm7005a1.htm. 

104Poteat TC, Reisner SL, Miller M, Wirtz AL. 

COVID–19 Vulnerability of Transgender Women 

With and Without HIV Infection in the Eastern and 

Southern U.S. Preprint. medRxiv. 

2020;2020.07.21.20159327. Published 2020 Jul 24. 

doi:10.1101/2020.07.21.20159327. 

105Martino, SC, Elliott, MN, Dembosky, JW, 

Hambarsoomian, K, Burkhart, Q, Klein, DJ, Gildner, 

J, and Haviland, AM. Racial, Ethnic, and Gender 

Disparities in Health Care in Medicare Advantage. 

Baltimore, MD: CMS Office of Minority Health. 

2020. 

106 Guide to Reducing Disparities in 

Readmissions. CMS Office of Minority Health. 

Revised August 2018. Available at: https://

www.cms.gov/About-CMS/Agency-Information/ 

OMH/Downloads/OMH_Readmissions_Guide.pdf. 

107Singh JA, Lu X, Rosenthal GE, Ibrahim S, 

Cram P. Racial disparities in knee and hip total 

joint arthroplasty: An 18-year analysis of national 

Medicare data. Ann Rheum Dis. 2014 

Dec;73(12):2107–15. 

108Rivera-Hernandez M, Rahman M, Mor V, 

Trivedi AN. Racial Disparities in Readmission Rates 

among Patients Discharged to Skilled Nursing 

Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672– 

1679. 

109 Joynt KE, Orav E, Jha AK. Thirty-Day 

Readmission Rates for Medicare Beneficiaries by 

Race and Site of Care. JAMA. 2011;305(7):675–681. 

110Tsai TC, Orav EJ, Joynt KE. Disparities in 

surgical 30-day readmission rates for Medicare 

beneficiaries by race and site of care. Ann Surg. Jun 

2014;259(6):1086–1090. 

111Rodriguez F, Joynt KE, Lopez L, Saldana F, Jha 

AK. Readmission rates for Hispanic Medicare 

beneficiaries with heart failure and acute 

myocardial infarction. Am Heart J. Aug 

2011;162(2):254–261 e253. 

112Centers for Medicare and Medicaid Services. 

Medicare Hospital Quality Chartbook: Performance 

Report on Outcome Measures; 2014. 

113 Guide to Reducing Disparities in 

Readmissions. CMS Office of Minority Health. 

Revised August 2018. Available at: https://

www.cms.gov/About-CMS/Agency-Information/ 

OMH/Downloads/OMH_Readmissions_Guide.pdf. 

114Prieto-Centurion V, Gussin HA, Rolle AJ, 

Krishnan JA. Chronic obstructive pulmonary 

disease readmissions at minority-serving 

institutions. Ann Am Thorac Soc. Dec 

2013;10(6):680–684. 

115 Joynt KE, Orav E, Jha AK. Thirty-Day 

Readmission Rates for Medicare Beneficiaries by 

Race and Site of Care. JAMA. 2011;305(7):675–681. 

116HHS. Heart disease and African Americans. 

(March 29, 2021). https://

www.minorityhealth.hhs.gov/omh/ 

browse.aspx?lvl=4&lvlid=19. 

117https://www.cms.gov/files/document/ 

medicare-covid-19-data-snapshot-fact-sheet.pdf. 

Continued 

resources in critical areas to support 

patient care and measurement such as 

social determinants of health. Through 

this coordination, we would identify 

which existing measures could be used 

or evolved to be used as dQMs, in 

recognition of current healthcare 

practice and priorities. 

This multi-stakeholder, joint Federal, 

State, and industry effort, made possible 

and enabled by the pending advances 

towards interoperability, would yield a 

significantly improved quality 

measurement enterprise. The success of 

the dQM portfolio would be enhanced 

by the degree to which the measures 

achieve our programmatic requirements 

as well as the requirements of other 

agencies and payers. 

5. Solicitation of Comments 

We seek input on the following steps 

that would enable transformation of 

CMS’ quality measurement enterprise to 

be fully digital: 

• What EHR/IT systems do you use 

and do you participate in a health 

information exchange (HIE)? 

• How do you currently share 

information with other providers and 

are there specific industry best practices 

for integrating SDOH screening into 

EHRs? 

• What ways could we incentivize or 

reward innovative uses of health 

information technology (IT) that could 

reduce burden for post-acute care 

settings, including but not limited to 

HHAs? 

• What additional resources or tools 

would post-acute care settings, 

including but not limited to HHAs, and 

health IT vendors find helpful to 

support testing, implementation, 

collection, and reporting of all measures 

using FHIR standards via secure APIs to 

reinforce the sharing of patient health 

information between care settings? 

• Would vendors, including those 

that service post-acute care settings, 

including but not limited to HHAs, be 

interested in or willing to participate in 

pilots or models of alternative 

approaches to quality measurement that 

would align standards for quality 

measure data collection across care 

settings to improve care coordination, 

such as sharing patient data via secure 

FHIR API as the basis for calculating 

and reporting digital measures? 

We plan to continue working with 

other agencies and stakeholders to 

coordinate and to inform our 

transformation to dQMs leveraging 

health IT standards. While we will not 

be responding to specific comments 

submitted in response to this Request 

for Information in the CY 2022 Home 

Health PPS final rule, we will actively 

consider all input as we develop future 

regulatory proposals or future 

subregulatory policy guidance. Any 

updates to specific program 

requirements related to quality 

measurement and reporting provisions 

would be addressed through separate 

and future notice- and-comment 

rulemaking, as necessary. 

B. Closing the Health Equity Gap in 

Post-Acute Care Quality Reporting 

Programs—Request for Information 

1. Background 

Significant and persistent inequities 

in health outcomes exist in the United 

States. In recognition of persistent 

health disparities and the importance of 

closing the health equity gap, we 

request information on expanding 

several related CMS programs to make 

reporting of health disparities based on 

social risk factors and race and ethnicity 

more comprehensive and actionable for 

providers and patients. Belonging to a 

racial or ethnic minority group; living 

with a disability; being a member of the 

lesbian, gay, bisexual, transgender, and 

queer (LGBTQ+) community; or being 

near or below the poverty level, is often 

associated with worse health 

outcomes.97 98 99 100 101 102 103 104 Such 

disparities in health outcomes are the 

result of number of factors, but 

importantly for CMS programs, although 

not the sole determinant, poor access 

and provision of lower quality health 

care contribute to health disparities. For 

instance, numerous studies have shown 

that among Medicare beneficiaries, 

racial and ethnic minority individuals 

often receive lower quality of care, 

report lower experiences of care, and 

experience more frequent hospital 

readmissions and operative 

complications.105 106 107 108 109 110

Readmission rates for common 

conditions in the Hospital Readmissions 

Reduction Program are higher for black 

Medicare beneficiaries and higher for 

Hispanic Medicare beneficiaries with 

Congestive Heart Failure and Acute 

Myocardial Infarction.111 112 113 114 115

Studies have also shown that African 

Americans are significantly more likely 

than white Americans to die 

prematurely from heart disease and 

stroke.116 The COVID–19 pandemic has 

further illustrated many of these 

longstanding health inequities with 

higher rates of infection, hospitalization, 

and mortality among black, Hispanic, 

and Indigenous and Native American 

persons relative to white persons.117 118


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35982 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

118Ochieng N, Cubanski J, Neuman T, Artiga S, 

and Damico A. Racial and Ethnic Health Inequities 

and Medicare. Kaiser Family Foundation. February 

2021. Available at: https://www.kff.org/medicare/ 

report/racial-and-ethnic-health-inequities-andmedicare/. 

119https://www.cdc.gov/coronavirus/2019-ncov/ 

community/health-equity/race-ethnicity.html. 

120https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/Quality

InitiativesGenInfo/Downloads/CMS-QualityStrategy.pdf. 

121Report to Congress: Improving Medicare PostAcute Care Transformation (IMPACT) Act of 2014 

Strategic Plan for Accessing Race and Ethnicity 

Data. January 5, 2017. Available at https://

www.cms.gov/About-CMS/Agency-Information/ 

OMH/Downloads/Research-Reports-2017-Report-toCongress-IMPACT-ACT-of-2014.pdf. 

122https://www.federalregister.gov/documents/ 

2021/01/25/2021-01753/advancing-racial-equityand-support-for-underserved-communities-throughthe-federal-government. 

123Centers for Medicare & Medicaid Services 

Office of Minority Health. The CMS Equity Plan for 

Improving Quality in Medicare. https://

www.cms.gov/About-CMS/Agency-Information/ 

OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_

090615.pdf. 

124https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/Quality

InitiativesGenInfo/MMF/General-info-Sub-Page. 

125Centers for Medicare and Medicaid Services. 

Building an Organizational Response to Health 

Disparities Inventory of Resources for Standardized 

Demographic and Language Data Collection. 2020. 

https://www.cms.gov/About-CMS/AgencyInformation/OMH/Downloads/Data-CollectionResources.pdf. 

126 In response to the COVID–19 PHE, CMS 

released an May 8, 2020 interim final rule with 

comment period (85 FR 27595 through 27597) 

which delayed the compliance date for the 

collection and reporting of the SDOH for at least 2 

full fiscal years after the end of the PHE. 

127https://qualitynet.cms.gov/inpatient/ 

measures/disparity-methods/methodology. 

As noted by the Centers for Disease 

Control ‘‘long-standing systemic health 

and social inequities have put many 

people from racial and ethnic minority 

groups at increased risk of getting sick 

and dying from COVID–19’’.119 One 

important strategy for addressing these 

important inequities is by improving 

data collection to allow for better 

measurement and reporting on equity 

across our programs and policies. 

We are committed to achieving equity 

in health care outcomes for our 

beneficiaries by supporting providers in 

quality improvement activities to reduce 

health inequities, enabling beneficiaries 

to make more informed decisions, and 

promoting provider accountability for 

health care disparities.120 121 For the 

purposes of this rule, we are using a 

definition of equity established in 

Executive Order 13985, as ‘‘the 

consistent and systematic fair, just, and 

impartial treatment of all individuals, 

including individuals who belong to 

underserved communities that have 

been denied such treatment, such as 

Black, Latino, and Indigenous and 

Native American persons, Asian 

Americans and Pacific Islanders and 

other persons of color; members of 

religious minorities; lesbian, gay, 

bisexual, transgender, and queer 

(LGBTQ+) persons; persons with 

disabilities; persons who live in rural 

areas; and persons otherwise adversely 

affected by persistent poverty or 

inequality.’’ 122 We note that this 

definition was recently established by 

the current administration, and provides 

a useful, common definition for equity 

across different areas of government, 

although numerous other definitions of 

equity exist. 

Our ongoing commitment to closing 

the equity gap in CMS quality programs 

is demonstrated by a portfolio of 

programs aimed at making information 

on the quality of health care providers 

and services, including disparities, more 

transparent to consumers and providers. 

The CMS Equity Plan for Improving 

Quality in Medicare aims to support 

Quality Improvement Networks and 

Quality Improvement Organizations 

(QIN–QIOs); Federal, State, local, and 

tribal organizations; providers; 

researchers; policymakers; beneficiaries 

and their families; and other 

stakeholders in activities to achieve 

health equity. The CMS Equity Plan 

includes three core elements: (1) 

Increasing understanding and awareness 

of disparities; (2) developing and 

disseminating solutions to achieve 

health equity; and (3) implementing 

sustainable actions to achieve health 

equity.123 The CMS Quality Strategy 

and Meaningful Measures 

Framework 124 include elimination of 

racial and ethnic disparities as a 

fundamental principle. Our ongoing 

commitment to closing the health equity 

gap in the HH QRP is demonstrated by 

seeking to adopt through future 

rulemaking Standardized Patient 

Assessment Data Elements under the 

HH QRP which include several social 

determinants of health (SDOH). 

We continue to work with Federal 

and private partners to better collect and 

leverage data on social risk to improve 

our understanding of how these factors 

can be better measured in order to close 

the health equity gap. Among other 

things, we have developed an Inventory 

of Resources for Standardized 

Demographic and Language Data 

Collection 125 and supported collection 

of specialized International 

Classification of Disease, 10th Edition, 

Clinical Modification (ICD–10–CM) 

codes for describing the socioeconomic, 

cultural, and environmental 

determinants of health. We continue to 

work to improve our understanding of 

this important issue and to identify 

policy solutions that achieve the goals 

of attaining health equity for all 

patients. 

2. Solicitation of Public Comment 

Under authority of the IMPACT Act 

and section 1895(b)(3)(B)(v) of the Act, 

we are seeking comment on the 

possibility of expanding measure 

development, and the collection of other 

Standardized Patient Assessment Data 

Elements that address gaps in health 

equity in the HH QRP. Any potential 

SPADE or measure reporting related to 

health equity data under the HH QRP 

that might result from public comments 

received in response to this solicitation 

would be addressed through a separate 

notice- and-comment rulemaking in the 

future. 

Specifically, we are inviting public 

comment on the following: 

• As finalized in the CY 2020 HH PPS 

final rule (84 FR 60597 through 60608), 

HHAs will be required to report 

Standardized Patient Assessment Data 

Elements on certain SDOH, including, 

ethnicity, preferred language, interpreter 

services, health literacy, transportation 

and social isolation.126 CMS is seeking 

guidance on any additional 

Standardized Patient Assessment Data 

Elements that could be used to assess 

health equity in the care of HHA 

patients, for use in the HH QRP. 

• Recommendations for how CMS 

can promote health equity in outcomes 

among HHA patients. We are also 

interested in feedback regarding 

whether including HHA-level quality 

measure results stratified by social risk 

factors and social determinants of health 

(for example, dual eligibility for 

Medicare and Medicaid, race) in 

confidential feedback reports could 

allow HHAs to identify gaps in the 

quality of care they provide (for 

example, methods similar or analogous 

to the CMS Disparity Methods 127 which 

provide hospital-level confidential 

results stratified by dual eligibility for 

condition-specific readmission 

measures currently included in the 

Hospital Readmission Reduction 

Program (84 FR 42496 through 42500). 

• Methods that commenters or their 

organizations use in employing data to 

reduce disparities and improve patient 

outcomes, including the source(s) of 

data used, as appropriate. 

• Given the importance of structured 

data and health IT standards for the 

capture, use, and exchange of relevant 

health data for improving health equity, 

the existing challenges HHAs encounter 

for effective capture, use, and exchange 

of health information include data on 

ethnicity and other social determinants 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35983 

128CDC COVID Data Tracker. Retrieved from: 

https://covid.cdc.gov/covid-data-tracker/#data

tracker-home. 129Here’s Exactly Where We are with Vaccine 

and Treatments for COVID–19. Healthline. May 11, 

2021. Retrieved from: https://www.healthline.com/ 

health-news/heres-exactly-where-were-at-withvaccines-and-treatments-for-covid-19. 

130COVID research: A year of scientific 

milestones. Nature. May 5, 2021. Retrieved from: 

https://www.nature.com/articles/d41586-020- 

00502-w. 

131Clinical trial of therapeutics for severely ill 

hospitalized COVID–19 patients begins. National 

Institutes of Health News Releases. April 22, 2021. 

Retrieved from: https://www.nih.gov/news-events/ 

news-releases/clinical-trial-therapeutics-severelyill-hospitalized-covid-19-patients-begins. 

132COVID–19 Treatment Guidelines. National 

Institutes of Health. Updated April 21, 2021. 

Retrieved from: https://www.covid19treatment

guidelines.nih.gov/whats-new/. 

133Ehsanian R, Workman J, Jones D, et al. Freestanding acute inpatient rehabilitation hospital 

enhanced practices and policies in response to the 

COVID–19 outbreak. Future Sci OA. 2021 Fe; 7(2): 

FSO667. Retrieved from: https://www.ncbi.nlm.

nih.gov/pmc/articles/PMC7745654/. 

134https://www.healthaffairs.org/do/10.1377/ 

hblog20201214.543463/full/. 

of health to support care delivery and 

decision-making. 

While we will not be responding to 

specific comments submitted in 

response to this Request for Information 

in the CY 2022 HH PPS final rule, we 

intend to use this input to inform future 

policy development. We look forward to 

receiving feedback on these topics, and 

note for readers that responses to the 

RFI should focus on how they could be 

applied to the HH QRP requirements. 

Please note that any responses provided 

will not impact payment decisions. 

IX. Revised Compliance Date for 

Certain Reporting Requirements 

Adopted for Inpatient Rehabilitation 

Facility (IRF) QRP and Long-Term Care 

Hospital (LTCH) QRP 

A. Proposed Revised Compliance Date 

for Certain Inpatient Rehabilitation 

Facility (IRF) QRP Reporting 

Requirements 

1. Background 

In IFC–2 (85 FR 27550), we delayed 

the compliance date for certain 

reporting requirements under the IRF 

QRP (85 FR 27595 through 27596). 

Specifically, we delayed the 

requirement for IRFs to begin reporting 

the Transfer of Health (TOH) 

Information to Provider-PAC and the 

TOH Information to Patient-PAC 

measures and the requirement for IRFs 

to begin reporting certain Standardized 

Patient Assessment Data Elements from 

October 1, 2020 to October 1st of the 

year that is at least one full fiscal year 

after the end of the COVID–19 PHE. 

CMS also delayed the adoption of the 

updated version of the IRF Patient 

Assessment Instrument (PAI) V4.0 with 

which IRFs would have used to report 

the TOH measures and certain 

Standardized Patient Assessment Data 

Elements. 

Under IFC–2, IRFs must use the IRF– 

PAI V4.0 to begin collecting data on the 

two TOH Information measures 

beginning with discharges on October 

1st of the year that is at least one full 

fiscal year after the end of the COVID– 

19 PHE. IRFs must also begin collecting 

data on certain Standardized Patient 

Assessment Data Elements on the IRF– 

PAI V4.0, beginning with admissions 

and discharges (except for the hearing, 

vision, race, and ethnicity Standardized 

Patient Assessment Data Elements, 

which would be collected at admission 

only) on October 1st of the year that is 

at least one full fiscal year after the end 

of the COVID–19 PHE. The delay to 

begin collecting data for these measures 

was intended to provide relief to IRFs 

from the added burden of implementing 

an updated instrument during the 

COVID–19 PHE. We wanted to provide 

maximum flexibilities for IRFs to 

respond to the public health threats 

posed by the COVID–19 PHE, and to 

reduce the burden in administrative 

efforts associated with attending 

trainings, training their staff, and 

working with their vendors to 

incorporate the updated assessment 

instruments into their operations. 

At the time we finalized the policy in 

the IFC–2, we believed that the delay in 

collection of the TOH Information 

measures and Standardized Patient 

Assessment Data Elements would not 

have a significant impact on the IRF 

QRP. However, the COVID–19 PHE 

showed the important need for theses 

TOH Information measures and 

Standardized Patient Assessment Data 

Elements under the HH QRP. The PHE’s 

disproportionate impact demonstrates 

the importance of analyzing this impact 

and the needs for these populations in 

order to improve quality of care within 

IRFs especially during a public health 

emergency. 

2. Current Assessment of IRFs 

To accommodate the COVID–19 PHE, 

CMS has provided additional guidance 

and flexibilities, and as a result IRFs 

have had the opportunity to adopt new 

processes and modify existing processes 

to accommodate the significant health 

crisis presented by the COVID–19 PHE. 

For example, CMS held regular ‘‘Office 

Hours’’ conference calls to provide IRFs 

regular updates on the availability of 

supplies, as well as answer questions 

about delivery of care, reporting and 

billing. CMS also supported PAC 

providers, including IRFs, by providing 

flexibilities in the delivery of care in 

response to the PHE, such as modifying 

the required face-to-face visits in IRF to 

be completed by telehealth (42 CFR 

412.622(a)(3)(iv) and 412.29(e)) during 

the PHE for COVID–19, and waiving the 

post-admission physician evaluation 

requirement at § 412.622(a)(4)(ii). In the 

FY 2021 IRF PPS final rule (86 FR 48445 

through 48447), CMS removed the postadmission physician evaluation 

requirement permanently beginning 

October 1, 2021. In addition, as of June 

9, 2021, 63.8 percent of the adult 

population has received at least one 

vaccination, and COVID–19 cases and 

deaths have steadily declined over the 

last 30 days.128 We also believe that 

much more is known about COVID–19 

than at the time CMS finalized IFC– 

2.129 130 131 132

Based upon other flexibilities such as 

the previous examples, the increase in 

knowledge IRF providers have about 

treating patients with COVID–19 133

since finalizing IFC–2, and the trending 

data on COVID–19, IRFs are in a better 

position to accommodate reporting of 

the TOH measures and certain (Social 

Determination of Health) Standardized 

Patient Assessment Data Elements. Also, 

recent reports (not available at the time 

CMS IFC–2 was finalized) suggest that 

IRFs have the capacity to begin 

reporting the TOH measures and certain 

Social Determinant of Health (SDOH) 

Standardized Patient Assessment Data 

Elements.134

After evaluating the impact of the 

revised compliance date under IFC–2, 

feasibility around data collection by 

IRFs, and support needs of providers 

during the COVID–19 PHE, we have 

determined that IRFs now have the 

administrative capacity to attend 

training, train their staff, and work with 

their vendors to incorporate the updated 

assessment instruments, the IRF–PAI 

V4.0 into their operations. 

We now believe that based upon the 

advancement of information available 

about COVID–19 vaccination and 

treatments described previously, and 

the importance of the data in the IRF 

QRP, it would be appropriate to modify 

the compliance date finalized in IFC–2. 

This may support future activities under 

Executive Order 13985, entitled 

‘‘Advancing Racial Equity and Support 

for Underserved Communities 

Throughout the Federal Government,’’ 

issued January 20, 2021(https://

www.federalregister.gov/documents/ 

2021/01/25/2021-01753/advancingracial-equity-and-support-forunderserved-communities-through-thefederal-government). 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35984 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

135CDC COVID Data Tracker. Retrieved from: 

https://covid.cdc.gov/covid-data-tracker/ 

#datatracker-home. 

136Here’s Exactly Where We are with Vaccine 

and Treatments for COVID–19. Healthline. May 11, 

2021. Retrieved from: https://www.healthline.com/ 

health-news/heres-exactly-where-were-at-withvaccines-and-treatments-for-covid-19. 

137COVID research: A year of scientific 

milestones. Nature. May 5, 2021. Retrieved from: 

https://www.nature.com/articles/d41586-020- 

00502-w. 

138Clinical trial of therapeutics for severely ill 

hospitalized COVID–19 patients begins. National 

Institutes of Health News Releases. April 22, 2021. 

Retrieved from: https://www.nih.gov/news-events/ 

news-releases/clinical-trial-therapeutics-severelyill-hospitalized-covid-19-patients-begins. 

3. Proposal To Collect the Transfer of 

Health Information to Provider-PAC 

Measure, the Transfer of Health 

Information to Patient-PAC Measure, 

and Certain Standardized Patient 

Assessment Data Elements Beginning 

October 1, 2022 

We are proposing to revise the 

compliance date from IFC–2 to October 

1, 2022. This revised date would begin 

the collection of data on the Transfer of 

Health Information to Provider-PAC 

measure and Transfer of Health 

Information to Patient-PAC measure, 

and certain Standardized Patient 

Assessment Data Elements on the 

updated version of the IRF–PAI 

assessment instrument referred to as 

IRF–PAI V4.0. This revised date of 

October 1, 2022, which is a 2-year delay 

from the original compliance date 

finalized in the FY 2020 IRF PPS final 

rule (84 FR 39054 through 39173), 

balances the support that IRFs needed 

during much of the COVID–19 PHE as 

CMS provided flexibilities to support 

IRFs along with the need to collect this 

important data. 

The need for the Standardized Patient 

Assessment Data Elements and TOH 

Information measures have been shown 

to be even more pressing with issues of 

inequities the COVID–19 PHE laid bare. 

This data that includes addressing 

SDOH provides information expected to 

improve quality of care for all. 

Consequently, we are proposing to 

revise the compliance date to reflect this 

balance and assure that data collection 

begins on October 1, 2022. 

As stated in the FY 2020 IRF PPS final 

rule, CMS will provide the training and 

education for IRFs to be prepared for 

this implementation (84 FR 39119 

through 39147). In addition, if CMS 

adopts an October 1, 2022 compliance 

date, CMS would release a draft of the 

updated version of the IRF–PAI, IRF– 

PAI V4.0, in early 2022. 

Based upon our evaluation, we 

propose that IRFs would collect the 

Transfer of Health Information to 

Provider-PAC measure, the TOH 

Information to the Patient-PAC measure, 

and certain Standardized Patient 

Assessment Data Elements beginning 

October 1, 2022. Accordingly, we 

propose that IRFs would begin 

collecting data on the two TOH 

measures beginning with discharges on 

October 1, 2022. We also propose that 

IRFs would begin collecting data on the 

six categories of Standardized Patient 

Assessment Data Elements on the IRF– 

PAI V4.0, beginning with admissions 

and discharges (except for the hearing, 

vision, race, and ethnicity Standardized 

Patient Assessment Data Elements, 

which would be collected at admission 

only) on October 1, 2022. 

We invite public comment on these 

proposals. 

B. Proposed Revised Compliance Date 

for Certain Long-Term Care Hospital 

(LTCH) QRP Reporting Requirements 

1. Background 

In IFC–2 (85 FR 27550), we delayed 

the compliance date for certain 

reporting requirements under the LTCH 

QRP (85 FR 27595 through 27596). 

Specifically, we delayed the 

requirement for LTCHs to begin 

reporting the TOH Information to 

Provider-PAC measure and the TOH 

Information to Patient-PAC measure and 

the requirement for LTCHs to begin 

reporting certain Standardized Patient 

Assessment Data Elements from October 

1, 2020 to October 1st of the year that 

is at least one full fiscal year after the 

end of the COVID–19 PHE. CMS also 

delayed the adoption of the updated 

version of the LTCH Continuity 

Assessment and Record of Evaluation 

(CARE) Data Set (LCDS) V5.0 with 

which LTCHs would have used to report 

the TOH measures and certain 

Standardized Patient Assessment Data 

Elements. 

Under IFC–2, LTCHs must use the 

LCDS V5.0 to begin collecting data on 

the two TOH Information measures 

beginning with discharges on October 

1st of the year that is at least one full 

fiscal year after the end of the COVID– 

19 PHE. LTCHs must also begin 

collecting data on certain Standardized 

Patient Assessment Data Elements on 

the LCDS V5.0, beginning with 

admissions and discharges (except for 

the hearing, vision, race, and ethnicity 

Standardized Patient Assessment Data 

Elements, which would be collected at 

admission only) on October 1st of the 

year that is at least one full fiscal year 

after the end of the COVID–19 PHE. The 

delay to begin collecting data for these 

measures was intended to provide relief 

to LTCHs from the associated burden of 

implementing an updated instrument 

during the COVID–19 PHE. We wanted 

to provide maximum flexibilities for 

LTCHs to respond to the public health 

threats posed by the COVID–19 PHE, 

and to reduce the burden in 

administrative efforts associated with 

attending trainings, training their staff, 

and working with their vendors to 

incorporate the updated assessment 

instruments into their operations. 

At the time we finalized the policy in 

the IFC–2, we believed that the delay in 

collection of the TOH Information 

measures, and Standardized Patient 

Assessment Data Elements would not 

have a significant impact on the LTCH 

QRP. However, the COVID–19 PHE 

showed the important need for theses 

TOH Information measures and 

Standardized Patient Assessment Data 

Elements under the LTCH QRP. The 

PHE’s disproportionate impact on 

minority populations demonstrates the 

importance of analyzing this impact and 

the needs for these populations in order 

to improve quality of care within LTCHs 

especially during a public health 

emergency. 

2. Current Assessment of LTCHs 

To accommodate the COVID–19 PHE, 

CMS has provided additional guidance 

and flexibilities, and as a result LTCHs 

have had the opportunity to adopt new 

processes and modify existing processes 

to accommodate the significant health 

crisis presented by the COVID–19 PHE. 

For example, CMS held regular ‘‘Office 

Hours’’ conference calls to provide 

LTCHs regular updates on the 

availability of supplies, as well as 

answer questions about delivery of care, 

reporting and billing. CMS also 

supported PAC providers, including 

LTCHs, by providing flexibilities in the 

delivery of care in response to the PHE, 

such as waiving requirement at 42 CFR 

482.43(a)(8), 482.61(e), and 

485.642(a)(8) to provide detailed 

information regarding discharge 

planning. To address workforce 

concerns related to COVID–19, CMS 

waived requirements under 42 CFR 

482.22(a)(1) through (4) to allow for 

physicians whose privileges would 

expire to continue practicing at the 

hospital and for new physicians to be 

able to practice before full medical staff/ 

governing body review and approval. In 

addition, as of June 9, 2021, 63.8 

percent of all the adult population has 

received at least one vaccination, and 

COVID–19 cases and deaths have 

steadily declined over the last 60 

days.135 We also believe that much more 

is known about COVID–19 than at the 

time CMS finalized IFC–2.136 137 138 139


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35985 

139COVID–19 Treatment Guidelines. National 

Institutes of Health. Updated April 21, 2021. 

Retrieved from: https://www.covid19treatment

guidelines.nih.gov/whats-new/. 

140Ehsanian R, Workman J, Jones D, et al. Freestanding acute inpatient rehabilitation hospital 

enhanced practices and policies in response to the 

COVID–19 outbreak. Future Sci OA. 2021 Fe; 7(2): 

FSO667. Retrieved from: https://www.ncbi.nlm.

nih.gov/pmc/articles/PMC7745654/. 

141https://www.healthaffairs.org/do/10.1377/ 

hblog20201214.543463/full/. 

Based upon other flexibilities such as 

the previous examples, the increase in 

knowledge LTCH providers have about 

treating patients with COVID–19 140

since finalizing IFC–2, and the trending 

data on COVID–19, LTCHs are now in 

a better position to accommodate 

reporting of the TOH measures and 

certain Standardized Patient 

Assessment Data Elements.141

After evaluating the impact of the 

revised compliance date under IFC–2, 

feasibility around data collection in 

LTCHs, and support needs of providers 

during the COVID–19 PHE, we have 

determined that LTCHs now have the 

administrative capacity to attend 

trainings, train their staff, and work 

with their vendors to incorporate the 

updated assessment instrument, the 

LCDS V5.0 into their operations. 

We now believe that based upon the 

advancement of information available 

about COVID–19 vaccination and 

treatments described previously, and 

the importance of the data to the LTCH 

QRP it would be appropriate to modify 

the compliance date finalized in IFC–2. 

This may support future activities under 

Executive Order 13985, entitled 

‘‘Advancing Racial Equity and Support 

for Underserved Communities Through 

the Federal Government,’’ issued 

January 20, 2021 (https://www.federal

register.gov/documents/2021/01/25/ 

2021-01753/advancing-racial-equityand-support-for-underservedcommunities-through-the-federalgovernment). 

3. Proposal To Collect the Transfer of 

Health Information to Provider-PAC 

Measure, the Transfer of Health 

Information to Patient-PAC Measure, 

and Certain Standardized Patient 

Assessment Data Elements Beginning 

October 1, 2022 

We are proposing to revise the 

compliance date from IFC–2 to October 

1, 2022. This revised date would begin 

the collection of data on the Transfer of 

Health Information to Provider-PAC 

measure and Transfer of Health 

Information to Patient-PAC measure, 

and certain Standardized Patient 

Assessment Data Elements on the 

updated version of the LCDS V5.0. This 

revised date of October 1, 2022, which 

is a two-year delay from this original 

compliance date finalized in the FY 

2020 IPPS/LTCH PPS final rule (84 FR 

42044 through 42701), balances the 

support that LTCHs needed during 

much of the COVID–19 PHE as CMS 

provided flexibilities to support LTCHs 

along with the need to collect this 

important data. 

The need for the Standardized Patient 

Assessment Data Elements and TOH 

Information measures have been shown 

to be even more pressing with issues of 

inequities the COVID–19 PHE laid bare. 

This data that includes addressing 

SDOH provides information expected to 

improve quality of care for all. 

Consequently, we are proposing to 

revise the compliance date to reflect this 

balance and assure that data reporting 

begins on October 1, 2022. 

As stated in the FY 2020 IPPS/LTCH 

PPS final rule, CMS will provide the 

training and education for LTCHs to be 

prepared for this implementation (84 FR 

42540 through 42560). In addition, if 

CMS adopts an October 1, 2022 

compliance date, CMS would release a 

draft of the updated version of the 

LCDS, LCDS V5.0, in early 2022. 

Based upon our evaluation, we 

propose that LTCHs would collect the 

Transfer of Health Information to 

Provider-PAC measure, the Transfer of 

Health Information to the Patient-PAC 

measure, and certain Standardized 

Patient Assessment Data Elements, 

beginning on October 1, 2022. We 

propose that accordingly, LTCHs would 

begin collecting data on the two TOH 

measures beginning with discharges on 

October 1, 2022. We also propose that 

LTCHs would begin collecting data on 

the six categories of Standardized 

Patient Assessment Data Elements on 

the LCDS V5.0, beginning with 

admissions and discharges (except for 

the hearing, vision, race, and ethnicity 

Standardized Patient Assessment Data 

Elements, which would be collected at 

admission only) on October 1, 2022. 

We invite public comment on these 

proposals. 

X. Collection of Information 

Requirements 

A. Statutory Requirement for 

Solicitation of Comments 

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. 

In this proposed rule, we are 

soliciting public comment on each of 

these issues for the following sections of 

this document that contain information 

collection requirements (ICRs). 

B. Collection of Information 

Requirements 

1. HH QRP 

In section IV.C. of this propose rule, 

we propose changes and updates to the 

HH QRP. We believe that the burden 

associated with the HH QRP proposals 

is the time and effort associated with 

data quality and reporting. As of March 

1, 2021, there are approximately 11,400 

HHAs reporting quality data to CMS 

under the HH QRP. For the purposes of 

calculating the costs associated with the 

information collection requirements, we 

obtained mean hourly wages for these 

from the U.S. Bureau of Labor Statistics’ 

May 2020 National Occupational 

Employment and Wage Estimates 

(https://www.bls.gov/oes/current/oes_

nat.htm). To account for overhead and 

fringe benefits (100 percent), we have 

doubled the hourly wage. These 

amounts are detailed in Table 35. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35986 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

In section IV.C.4.a. of the proposed 

rule, we are proposing to remove the 

Drug Education on All Medications 

Provided to Patient/Caregiver during All 

Episodes of Care measure under 

removal factor 1, measure performance 

among HHAs is so high and unvarying 

that meaningful distinctions in 

improvements in performance can no 

longer be made. Additionally, we are 

proposing to remove the OASIS item 

M2016 used to calculate this measure. 

This item removal will result in a 

decrease in overall burden. 

In sections IV.C.4.b. and c. of the 

proposed rule, we are proposing to 

adopt the Home Health Within Stay 

Potentially Preventable Hospitalization 

claims-based measure. We are proposing 

to replace the Acute Care 

Hospitalization During the First 60 Days 

of HH (NQF #0171) measure and the 

Emergency Department Use without 

Hospitalization During the First 60 Days 

of HH (NQF #0173) measure with the 

Within Stay Potentially Hospitalization 

measure beginning with the CY 2023 

HH QRP under our measure removal 

factor 6: A measure that is more strongly 

associated with desired patient 

outcomes for the particular topic is 

available. Because the measures are 

claims-based, the replacement/removal 

will not impact collection of 

information. 

Therefore, we are proposing a net 

reduction of 1 data element at the 

Discharge from Agency time point and 

1 data element at the Transfer of Care 

time point associated with OASIS item 

(M2016) collection as a result of the 

measure removal. We assume that each 

data element requires 0.3 minutes of 

clinician time to complete. Therefore, 

we estimate that there would be a 

reduction in clinician burden per 

OASIS assessment of 0.3 minutes at 

Discharge from Agency and 0.3 minutes 

at Transfer of Care. 

The OASIS is completed by RNs or 

PTs, or very occasionally by 

occupational therapists (OTs) or speech 

language pathologists (SLT/SP). Data 

from 2020 show that the OASIS is 

completed by RNs (approximately 76.5 

percent of the time), PTs (approximately 

20.78 percent of the time) and other 

therapists including OTs and SLP/STs 

(approximately 2.72 percent of the 

time). Based on this analysis, we 

estimated a weighted estimated 

clinician average hourly wage of $79.41, 

inclusive of fringe benefits using the 

wage data from Table 35. Individual 

providers determine the staffing 

necessary. 

Table 36 shows the total number of 

assessments submitted in CY 2020 and 

estimated costs at each time point. 

Based on the data in Table 35 and 

Table 36 for the 11,400 active Medicarecertified HHAs, we estimate the total 

decrease in costs associated with the 

changes in the HH QRP at 

approximately $242 per HHA annually 

or $2,762,277 for all HHAs. This 

corresponds to an estimated decrease in 

clinician burden associated proposed 

changes to the HH QRP of 

approximately 3.1 hours per HHA or 

approximately 34,785 hours for all 

HHAs. This decrease in burden would 

be accounted for in the information 

collection under OMB control number 

0938–1279 (Expiration date: 12/31/ 

2021). 

In section IV.C. of this proposed rule, 

we propose a revised compliance date 

for certain reporting requirements 

adopted for the HH QRP. The burden for 

the proposed revision to the HH QRP 

requirements as adopted in the CY 2020 

HH PPS final rule (84 FR 60632 through 

60642) has been accounted for in OMB 

control number 0938–1279. Therefore, 

this proposal would not affect the 

information collection burden already 

established. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.054</GPH> EP07JY21.055</GPH>

TABLE 35: U.S. BUREAU OF LABOR STATISTICS' MAY 2020 NATIONAL 

OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES 

Mean Fringe Adjusted 

Hourly Benefit 

Occupation Wage (100%) 

Occupation title Code ($/hr) ($/hr) 

Registered Nurse (RN) 29-1141 $38.47 $38.47 

Phvsical therapists HHAs 29-1123 $44.08 $44.08 

Speech-Language Pathologists (SLP) 29-1127 $40.02 $40.02 

Occupational Therapists (OTI 29-1122 $42.06 $42.06 

Medical Dosimetrists, Medical Records Specialists, and Health Technologists and Technicians 29-2098 $23.21 $23.21 

TABLE 36: CY 2020 OASIS SUBMISSIONS AND ESTIMATED COSTS, BY TIME 

POINT 

CY 2020 Assessments Estimated 

Time Point Completed Cost($) 

Transfer of Care 1,788,100 $4,259,791 

Discharge from agency 5,168,903 $228,832,891 

TOTAL 6,957,003 $233,092,681 

* Estimated Burden($) at each Time-Point=(# CY 2020 Assessments Completed) x (clinician burden 

[min]/60) x ($79.41 [weighted clinician average hourly wage]). Excluding M2016, there are 1.8 minutes to 

complete transfer of care 6 transfer of care data elements and 33 .45 minutes to complete 123 data elements 

at discharge. 

Hourly 

Wage 

($/hr) 

$76.94 

$88.16 

$80.04 

$84.12 

$46.42 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35987 

2. ICRs Regarding Revised Compliance 

Dates for Certain Reporting 

Requirements 

a. IRF QRP Requirements 

In section VIII.A. of this proposed 

rule, we propose to revise the 

compliance date for certain reporting 

requirements adopted for the IRF QRP. 

We believe that the burden associated 

with the IRF QRP proposal is the time 

and effort associated with reporting 

quality data. As of April 4, 2021, there 

are approximately 1,109 IRFs reporting 

quality data to CMS. The burden for the 

proposed revision to the IRF QRP 

requirements as adopted in the FY 2020 

IRF PPS final rule (84 FR 39165 through 

39172) has been accounted for in OMB 

control number 0938–0842 (Expiration 

date: 12/31/2022). Therefore, this 

proposal would not affect the 

information collection burden for the 

IRF QRP. 

b. LTCH QRP Requirements 

In section VIII.B. of this proposed 

rule, we propose a revised compliance 

date for certain reporting requirements 

adopted for the LTCH QRP. We believe 

that the burden associated with the 

LTCH QRP proposal is the time and 

effort associated with reporting quality 

data. As of April 21, 2021, there are 

approximately 363 LTCHs reporting 

quality data to CMS. The burden for the 

proposed revision to the LTCH QRP 

requirements as adopted in the FY 2020 

IPPS/LTCH PPS final rule (84 FR 42602 

through 42656) has been accounted for 

in OMB control number 0938–1163 

(expiration12/31/2022). Therefore, this 

proposal would not affect the 

information collection burden for the 

LTCH QRP. 

3. ICRs Related to the Changes in the 

Home Health CoPs 

a. ICRs Related to the Virtual 

Supervision of HHA Aides 

In section IV.D. of this propose rule, 

we would revise § 484.80(h)(1) to 

specify that if a patient is receiving 

skilled care (patient who is receiving 

skilled nursing, physical or 

occupational therapy, or speech 

language pathology services), the home 

health aide supervisor (RN or therapist) 

must complete a supervisory assessment 

of the aide services being provided, 

either onsite (that is, an in person visit) 

or using interactive telecommunications 

systems no less frequently than every 14 

days. The home health aide would not 

have to be present during the 

supervisory assessment. The use of 

interactive telecommunications systems 

for the aide supervisory assessment 

must not exceed 2 times per HHA in a 

60-day period. We propose to revise 

§ 484.80(h)(2) to specify that, if a patient 

is not receiving skilled care, the RN 

must make an in-person supervisory 

visit to the location where the patient is 

receiving care, once every 60 days to 

assess the quality of care and services 

provided by the home health aide and 

to ensure that services meet the patient’s 

needs. The home health aide does not 

need to be present during this visit. We 

are also proposing that the RN would 

make a semi-annual on-site (in-person) 

visit to the location where a patient is 

receiving care in order to observe and 

assess the home health aide while he or 

she was performing care. This semiannual supervisory visit of the aide 

performing care would replace the 

current every 60-day requirement of 

direct supervision of the aide 

performing care. Section 484.80(h) also 

requires HHAs to document the 

supervision of home health aides in 

accordance with specified timeframes. 

In addition, we believe the modification 

proposed at § 484.80(h)(3) includes 

retraining and competency evaluations 

related to both the skills verified as 

deficient and to any related skills will 

not add any information collection 

burden and will enhance the provisions 

of safe, quality home health services. In 

accordance with the implementing 

regulation of the PRA at 5 CFR 

1320.3(b)(2), we believe that both the 

existing requirements and the proposed 

revisions to the requirements at 

484.80(h) are exempt from the PRA. We 

believe competency evaluations are a 

usual and customary business practice 

and we state as such in the information 

collection request associated with the 

Home Health CoPs (OMB control 

number: 0938–1299/Expiration: 06/30/ 

2021). Therefore, we are not proposing 

to seek PRA approval for any 

information collection or recordkeeping 

activities that may be conducted in 

connection with the proposed revisions 

to § 484.80(h), but we request public 

comment on our determination that the 

time and effort necessary to comply 

with these evaluation requirements is 

usual and customary, and would be 

incurred by home health staff even 

absent this regulatory requirement. 

b. ICRs Related to Permitting 

Occupational Therapist To Complete 

the Initial and Comprehensive 

Assessments for Home Health Agencies 

In section IV.D. of this proposed rule, 

we would implement Division CC, 

section 115 of CAA 2021 by proposing 

conforming regulations text changes at 

§ 484.55(a)(2) and (b)(3) permitting the 

occupational therapist to complete the 

initial and comprehensive assessments 

for Medicare patients when ordered 

with another rehabilitation therapy 

service (speech language pathology or 

physical therapy) that establishes 

program eligibility, in the case where 

skilled nursing services are also not 

initially on the home health plan of 

care. These changes permit occupational 

therapists to complete these assessments 

even though the need for occupational 

therapy would not establish the 

patient’s eligibility for the Medicare 

home health benefit. In accordance with 

the implementing regulations of the 

PRA at 5 CFR 1320.3(b)(2), we believe 

that both the existing requirements and 

the proposed revisions to the 

requirements at § 484.55(a)(2) and (b)(3) 

are exempt from the PRA. We believe 

patient assessment are a usual and 

customary business practice and we 

state such in the information collection 

request associated with the OASIS data 

set, which comprises the core of the 

patient assessment and is currently 

approved under OMB control number: 

0938–1279 (Expiration date: 06/30/ 

2024). Therefore, we are not proposing 

to seek PRA approval for any 

information collection or recordkeeping 

activities that may be conducted in 

connection with the proposed revisions 

to § 484.55(a)(2) and (b)(3), but we 

request public comment on our 

determination that the time and effort 

necessary to comply with these 

evaluation requirements is usual and 

customary and would be incurred by 

home health staff even absent this 

regulatory requirement. 

4. ICRs Regarding Medicare Provider 

and Supplier Enrollment Provisions 

We do not anticipate any information 

collection burden associated with our 

provider and supplier enrollment 

proposals. Since most of these proposals 

have been in subregulatory guidance for 

a number of years and we are simply 

incorporating them into regulation, 

there would not be any change in 

burden on the provider community. 

Those provisions that are not in 

subregulatory guidance do not implicate 

information collection requirements. 

5. ICRs Regarding Survey and 

Enforcement Requirements for Hospices 

a. Wage Data 

To derive average costs, we used data 

from the U.S. Bureau of Labor Statistics’ 

May 2020 National Occupational 

Employment and Wage Estimates for all 

salary estimates (http://www.bls.gov/ 

oes/current/oes_nat.htm). In this regard, 

Table 37 presents the mean hourly 

wage, the cost of fringe benefits and 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35988 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

overhead (calculated at 100 percent of 

salary), and the adjusted hourly wage. 

b. Application and Re-Application 

Procedures for National Accrediting 

Organizations (§ 488.5) 

We proposed at § 488.5(a)(4)(x) to 

require AOs with CMS-approved 

hospice programs to include a statement 

of deficiencies, (that is, the Form CMS– 

2567 or a successor form) to document 

findings of the hospice Medicare CoPs 

and to submit such in a manner 

specified by CMS. The current 

information collection request for the 

form CMS–2567, titled ‘‘Statement Of 

Deficiencies And Plan Of Correction’’ 

(OMB control number 0938–0391/ 

Expiration date: 6/30/2021) does not 

account for any information collection 

related burden associated with AO use. 

As discussed in the preamble of this 

proposed rule, in section VII.B.2.b. of 

this proposed rule, we note that the 

currently approved Form CMS–2567 

does not include a place for the name 

of the AO completing the survey and 

AOs are not addressed in the 

instructions. These are minor revisions 

to the form but we will submit the 

revised information collection request to 

OMB for approval. 

We discussed in the preamble section 

VII.B.2.b. of this proposed rule, how 

AOs conduct hospice program surveys 

and gather deficiency findings into a 

report that is provided to the surveyed 

hospice. CMS believes the statutory 

requirement and subsequent proposed 

rule for the inclusion of Form CMS– 

2567 would not add significant burden 

to AOs as they already develop 

deficiency finding reports as part of 

their existing process just in a different 

format. We note that AOs would need 

to make a one-time update to their 

existing proprietary electronic 

documentation systems to include the 

Form CMS–2567. We estimate that this 

task would be performed by a computer 

and information analyst. According to 

the U.S Bureau of Labor statistics, the 

mean hourly wages for a computer and 

information analyst is $48.40. This wage 

adjusted for the employer’s fringe 

benefits and overhead would be $96.80. 

We estimate that it would take at least 

two persons working on a full-time basis 

for 3 days for the AO staff to revise their 

system to add the required Form CMS– 

2567. Therefore, we estimate that the 

total time required for the two team 

members to perform this task would be 

48 hours. As of March 2021, there are 

three AOs that accredit Medicare 

certified hospice programs. The total 

time burden across these three AOs 

would be 144 hours. 

We estimate that the cost burden 

related to the work performed by two 

computer and information analysts 

would be $4,646.50 (24 hours × $193.60 

($96.80 × 2)). The total cost across the 

three AOs would be $13,939.50 (3 AOs 

× $4,646.50). The burden associated 

with this requirement will be submitted 

to OMB under OMB control number 

0938–NEW (Expiration date: pending). 

We seek comments that would help us 

to develop an accurate estimate of the 

cost and time burden that would result 

from this collection of information. 

These are minor revisions to the form; 

however, as required under the PRA we 

will be seeking OMB approval for a 

revised version of the form. Please note, 

we will be seeking OMB approval via 

the required notice and comment 

periods but they will be separate from 

this proposed rulemaking. The revised 

information collection request will be 

announced in the Federal Register and 

the public will have the opportunity to 

review and comment as necessary. 

c. Surveyor Qualifications and 

Prohibition of Conflicts of Interest 

(§ 488.1115) 

We proposed at § 488.1115, to require 

AO surveyors to complete the online 

hospice basic training. As discussed in 

the preamble section VII.B.2.d. of this 

proposed rule, we note there are 

multiple online training programs 

available to SA surveyors on the CMS 

QSEP website. These courses are selfpaced, slide based presentations and the 

person taking the course can take the 

courses over a period of time. The 

amount of time required to complete 

each of these training courses varies 

depending on the pace at which the 

surveyor is able to read through or listen 

to the presentation and complete the 

training. Duration time is based on the 

estimate that it takes learners 

approximately 2 minutes per slide. This 

information is publicly available on 

https://qsep.cms.gov/welcome.aspx. We 

proposed that each AO hospice program 

surveyor take the hospice basic training 

course that has an average completion 

time of 24 hours. Completion time could 

be more or less depending upon the 

learner’s familiarity with the content 

and overall learning style. Therefore, a 

hospice program AO surveyor would 

incur a time burden of approximately 24 

hours for the completion of this CMS 

surveyor training course. 

The AOs that accredit Medicare 

certified hospice programs would incur 

a cost burden for the wages of their 

surveyors for the time they spend taking 

these online surveyor training courses. 

Most surveyors are clinicians such as 

RNs. 

As noted, we estimated that it would 

take approximately 24 hours for each 

AO surveyor to complete the hospice 

basic training online surveyor course. 

Therefore, the AO would incur wages in 

the amount of $1,846.56 per each 

surveyor that completes the CMS online 

surveyor training (24 hours × $76.94). 

We are not able to precisely estimate 

total time and cost burden to each AO 

for the wages incurred for the time spent 

by all surveyors from each of the three 

hospice program AOs to take the CMS 

online surveyor training course, because 

each AO varies greatly in organization 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.056</GPH>

TABLE 37: U.S. BUREAU OF LABOR STATISTICS' MAY 2020 NATIONAL 

OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES 

Home Health and Personal Care Aides; and Nursing 

Assistants, Orderlies, and P chiatric Aides 

Re · stered Nurse 

31-1100 

11-9111 

29-1141 

$55.37 $55.37 

$38.47 $38.47 

$110.74 

$76.94 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35989 

size, number of accreditation programs 

approved by CMS, and total surveyor 

cadre numbers. There are no regulatory 

requirements for AOs to report to CMS 

on the number of surveyors within their 

organization nor information on how 

many of those surveyors survey each 

type of program approved by CMS. CMS 

notes there is a wide variety of total 

surveyor cadre numbers across all three 

AOs, based on information CMS has 

gathered from confidential numbers, 

voluntarily provided by some of the 

AOs to CMS, as part of their deeming 

authority application documents as well 

as information found online via a search 

of each AOs public website. Variation is 

generally based on the associated 

number of CMS-approved accreditation 

programs the AO possesses. For 

example, AOs who accredit only one 

provider or supplier type generally have 

about 25 surveyors while AOs with 

multiple programs have surveyor 

numbers well over 300 thereby skewing 

the ability to estimate an accurate time 

burden that represents the overall 

group. Because of this wide range CMS 

is estimating near the middle, using 100 

total surveyors per AO. If we estimate 

that each AO has approximately 100 

total surveyors, the estimated time 

burden to each AO associated with this 

requirement would be 2,400 hours (24 

hours × 100 surveyors). 

The estimated cost burden to each AO 

(that accredits Medicare-certified 

hospice programs) associated with this 

requirement would be $184,656 (2,400 

hours × $76.94 per hour). The burden 

associated with this requirement will be 

submitted to OMB under OMB control 

number 0938–NEW (Expiration date: 

pending). 

As of March 2021, there are three AOs 

that accredit Medicare-certified hospice 

programs. We estimate that the time 

burden across all of these AOs 

associated with the requirement that 

their surveyors take the CMS online 

surveyor training would be 7,200 hours 

(2,400 hours × 3 AOs). 

The estimated cost across all AOs 

(that accredit Medicare-certified hospice 

programs) would be $553,968 ($184,656 

× 3 AOs). We request feedback on the 

total number of AO hospice program 

surveyors we should consider, 

especially if our estimate of 100 is 

grossly under or over estimated. 

6. HHVBP Expanded Model 

In section III. of this proposed rule, 

we propose policies necessary to 

implement the expanded Home Health 

Value-Based Purchasing Model (see 

proposed §§ 484.340 through 484.375), 

which is aimed at increasing quality and 

reducing spending through payment 

adjustments based on quality 

performance for HHAs nationwide. 

Section 1115A(d)(3) of the Act exempts 

Innovation Center model tests and 

expansions, which include the HHVBP 

expanded model, from the provisions of 

the PRA. Specifically, this section 

provides that the provisions of the PRA 

does not apply to the testing and 

evaluation of Innovation Center models 

or to the expansion of such models. 

C. Submission of PRA-Related 

Comments 

We have submitted a copy of this 

proposed rule to OMB for its review of 

the rule’s information collection and 

recordkeeping requirements. The 

requirements are not effective until they 

have been approved by OMB. 

We invite public comments on these 

information collection requirements. If 

you wish to comment, please identify 

the rule (CMS–1747–P) and, where 

applicable, the preamble section, and 

the ICR section. See this rule’s DATES

and ADDRESSES sections for the 

comment due date and for additional 

instructions. 

XI. Regulatory Impact Analysis 

A. Statement of Need 

1. 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 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 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 casemix 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. 

2. HHVBP Model 

Section 1115A(c) of the Act provides 

the Secretary with the authority to 

expand (including implementation on a 

nationwide basis), through notice and 

comment rulemaking, the duration and 

scope of a model that is being tested 

under section 1115A(b) of the Act if the 

following findings are made, taking into 

account the evaluation of the model 

under section 1115A(b)(4) of the Act: (1) 

The Secretary determines that the 

expansion is expected to either reduce 

spending without reducing quality of 

care or improve the quality of patient 

care without increasing spending; (2) 

the CMS Chief Actuary certifies that the 

expansion would reduce (or would not 

result in any increase in) net program 

spending; and (3) the Secretary 

determines that the expansion would 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35990 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

142https://www.cms.gov/files/document/ 

certification-home-health-value-based-purchasinghhvbp-model.pdf. 

not deny or limit the coverage or 

provision of benefits. On January 8, 

2021, we announced that the HHVBP 

Model (the original Model) had been 

certified for expansion nationwide,142 as 

well as our intent to expand the Model 

through notice and comment 

rulemaking beginning no sooner than 

CY 2022. The original Model has 

resulted in an average 4.6 percent 

improvement in home health agencies’ 

quality scores as well as average annual 

savings of $141 million to Medicare. 

The CMS Chief Actuary has determined 

that HHVBP Model would reduce 

Medicare expenditures if expanded to 

all States. 

If finalized, all Medicare-certified 

HHAs in the 50 States, District of 

Columbia and the territories would be 

required to participate in the expanded 

HHVBP Model beginning January 1, 

2022. These HHAs would compete on 

value based on an array of quality 

measures that capture the services 

provided by HHAs. The savings impacts 

related to the HHVBP Model expansion 

are estimated at a total projected 5-year 

gross FFS savings, CYs 2022 through 

2026, of $3,154,000,000. The savings 

under the original Model are already 

assumed in the baseline and therefore 

are not included in the 5-year gross 

estimated savings under HHVBP Model 

expansion. As previously mentioned in 

section III.A.3.b. of this proposed rule, 

under the expanded duration and scope 

of this Model, we would continue to 

examine whether the proposed 

adjustments to the Medicare payment 

amounts that would otherwise be made 

to competing HHAs would result in 

statistically significant improvements in 

the quality of care being delivered to 

Medicare beneficiaries, as well as 

reductions in Medicare spending. 

3. HH QRP 

Section 1895(b)(3)(B)(v) of the Act 

requires HHAs to submit data in 

accordance with the requirements of the 

HH QRP and requires HHAs to submit 

data for purposes of measuring health 

care quality, and links the quality data 

submission to the annual applicable 

percentage increase. 

4. Effects of the Changes to the Home 

Health CoPs 

a. Virtual Supervision of HHA Aides 

In section IV.D. of this rule, we 

propose to revise the CoPs for home 

health agencies. Specifically, in section 

IV.D. of this rule, we propose to revise 

the home health aide supervision 

requirements to allow for virtual 

supervision. The burden may be 

reduced for providers by improving the 

efficiency of the training and 

supervision of home health aides. We 

are also adding the requirement that the 

skills related to any deficient skills be 

addressed. We believe the burden 

associated with addressing skills related 

to those identified as deficient skills is 

minimal. Moreover, supervising 

employees to ensure the safe and 

effective provision of patient care is 

standard business practice throughout 

the health care community. Likewise, 

documenting that this supervision has 

occurred for internal personnel, 

accreditation, and State and Federal 

compliance purposes constitutes a usual 

and customary business practice. 

Therefore, the regulatory impact is 

negligible. 

b. Permitting Occupational Therapists 

To Conduct the Initial Assessment Visit 

and Complete the Comprehensive 

Assessment for Home Health Agencies 

Under the Medicare Program 

In accordance with Division CC, 

section 115 of CAA 2021, we are 

proposing conforming regulations text 

changes to permit the occupational 

therapist to complete the initial and 

comprehensive assessments for 

Medicare patients when ordered with 

another rehabilitation therapy service 

(speech language pathology or physical 

therapy) that establishes program 

eligibility, in the case where skilled 

nursing services are also not ordered. 

We do not expect any increase in 

burden for any of these modifications. 

In fact, for home health agencies, 

burden may be reduced by expanding 

the type of therapy discipline able to 

complete the initial and comprehensive 

assessments, in some circumstances, for 

Medicare patients. We do not expect the 

changes for these provisions will cause 

any appreciable amount of expense or 

anticipated saving and we do not 

believe this standard would impose any 

additional regulatory burden. 

5. Medicare Coverage of Home Infusion 

Therapy 

Section 1834(u)(1) of the Act, as 

added by section 5012 of the 21st 

Century Cures Act, requires the 

Secretary to establish a home infusion 

therapy services payment system under 

Medicare. This payment system requires 

a single payment to be made to a 

qualified home infusion therapy 

supplier for items and services 

furnished by a qualified home infusion 

therapy supplier in coordination with 

the furnishing of home infusion drugs. 

Section 1834(u)(1)(A)(ii) of the Act 

states that a unit of single payment is for 

each infusion drug administration 

calendar day in the individual’s home. 

The Secretary shall, as appropriate, 

establish single payment amounts for 

types of infusion therapy, including to 

take into account variation in utilization 

of nursing services by therapy type. 

Section 1834(u)(1)(A)(iii) of the Act 

provides a limitation to the single 

payment amount, requiring that it shall 

not exceed the amount determined 

under the Physician Fee Schedule 

(under section 1848 of the Act) for 

infusion therapy services furnished in a 

calendar day if furnished in a physician 

office setting, except such single 

payment shall not reflect more than 5 

hours of infusion for a particular 

therapy in a calendar day. Section 

1834(u)(1)(B)(i) of the Act requires that 

the single payment amount be adjusted 

by a geographic wage index. Finally, 

section 1834(u)(1)(C) of the Act allows 

for discretionary adjustments which 

may include outlier payments and other 

factors as deemed appropriate by the 

Secretary, and are required to be made 

in a budget neutral manner. 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 percentage 

increase in the CPI–U for all urban 

consumers for the 12-month period 

ending with June of the preceding year, 

reduced by the productivity adjustment. 

The unit of single payment for each 

infusion drug administration calendar 

day, including the required adjustments 

and the annual update, cannot exceed 

the amount determined under the fee 

schedule under section 1848 of the Act 

for infusion therapy services if 

furnished in a physician’s office, and 

the single payment amount cannot 

reflect more than 5 hours of infusion for 

a particular therapy per calendar day. 

Finally, Division N, section 101 of CAA 

2021 amended section 1848(t)(1) of the 

Act and modified the CY 2021 PFS rates 

by providing a 3.75 percent increase in 

PFS payments only for CY 2021. 

6. Medicare Provider and Supplier 

Enrollment Provisions 

Our proposals concerning Medicare 

provider and supplier enrollment are 

needed to (1) incorporate various 

subregulatory policies into 42 CFR part 

424, subpart P, and (2) clarify several 

policy issues. We believe these 

proposals would increase transparency 

by allowing the provider community to 

furnish public comments on them while 

eliminating uncertainty regarding the 

scope and applicability of the 

provisions in question. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35991 

7. Survey and Enforcement 

Requirements for Hospice Providers 

In accordance with section 407 of the 

CAA 2021, we propose conforming 

regulations which establish new hospice 

program survey and enforcement 

requirements. We believe these 

proposals not only meet the statutory 

requirements but would increase public 

transparency by encouraging a 

consistent survey and enforcement 

process and providing the public with 

information necessary to make an 

informed decision regarding where they 

seek high quality, safe care hospice 

program organizations for themselves or 

loved ones. 

B. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Act, section 

202 of the Unfunded Mandates Reform 

Act of 1995 (March 22, 1995; Pub. L. 

104–4), Executive Order 13132 on 

Federalism (August 4, 1999), and the 

Congressional Review Act (5 U.S.C. 

801(a)(1)(B)(i)). 

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. 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. 

The following summary provides the 

economic impact estimates associated 

with the provisions of this proposed 

rule: 

1. Overall Impacts—HH PPS 

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 

2022 is estimated to be $310 million (1.7 

percent). 

2. Overall Impacts—Home Health Value 

Based Purchasing Model Expansion 

Beginning in CY 2024 and in each 

succeeding payment year under the 

expanded HHVBP Model, we would 

adjust the final claim payment amount 

for a home health agency for a date of 

service in the calendar year by an 

amount up to the maximum applicable 

percent. For purposes of this proposed 

rule, we have limited our analysis of the 

economic impacts to the value-based 

incentive payment adjustments. Under 

the expanded Model design, the 

incentive payment adjustments would 

be limited to the total payment 

reductions to home health agencies 

included in the expanded Model, such 

that in aggregate, payment reductions to 

lower-performing HHAs would 

approximate the aggregate payment 

increases to higher-performing HHAs. 

Overall, the impact of this rule is 

estimated at $3,154,000,000 for CYs 

2022 to 2026, though these savings 

result primarily from reductions in 

utilization of services, including acute 

hospital admissions and skilled nursing 

facility (SNF) visits. The expanded 

Model would test the effect on quality 

and costs of care by applying payment 

adjustments based on HHAs’ 

performance on quality measures. 

C. Detailed Economic Analysis 

1. HH PPS 

This rule proposes updates to 

Medicare payments under the HH PPS 

for CY 2022. 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 home health 

benefit, based primarily on Medicare 

claims data for periods ending on or 

before December 31, 2020. 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 38 represents how HHA 

revenues are likely to be affected by the 

policy changes proposed in this rule for 

CY 2022. For this analysis, we used an 

analytic file with linked CY 2020 OASIS 

assessments and home health claims 

data for dates of service that ended on 

or before December 31, 2020. The first 

column of Table 38 classifies HHAs 

according to a number of characteristics 

including provider type, geographic 

region, and urban and rural locations. 

The second column shows the number 

of facilities in the impact analysis. The 

third column shows the payment effects 

of the Case-Mix Weights Recalibration 

Neutrality Factor. 

The fourth column shows the 

payment effects of updating to the CY 

2022 wage index. The fifth column 

shows the payment effects of the CY 

2022 rural add-on payment provision in 

statute. The sixth column shows the 

payment effects of the proposed CY 

2022 home health payment update 

percentage and the last column shows 

the combined effects of all the proposals 

in this rule. 

Overall, it is projected that aggregate 

payments in CY 2022 would increase by 

1.7 percent. As illustrated in Table 38, 

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 2022 

wage index, the percentage of total HH 

PPS payments that were subject to the 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
35992 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

LUPA or paid as outlier payments, and 

the degree of Medicare utilization. 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.057</GPH>

TABLE 38: ESTIMATED HHA IMPACTS BY FACILITY TYPE AND AREA OF THE 

COUNTRY, CY 2022 

CY2022 

Case-Mix Proposed 

Weights HH 

Number Recalibration CY2022 CY2022 Payment 

of Neutrality Updated Rural Update 

A2encies Factor Wa2e Index Add-On Percenta2e Total 

All A2encies 9,401 0.0% 0.0% -0.1% 1.8% 1.7% 

Facility Type and Control 

Free-Standing/Other Vol/NP 939 0.4% -0.3% -0.1% 1.8% 1.8% 

Free-Standing/Other Pronrietarv 7 588 -0.2% 0.1% -0.1% 1.8% 1.6% 

Free-Standing/Other Government 183 0.8% 0.1% -0.4% 1.8% 2.3% 

Facility-Based Vol/NP 487 0.6% -0.1% -0.2% 1.8% 2.1% 

Facility-Based Proprietarv 50 0.3% 0.0% -0.2% 1.8% 1.9% 

Facility-Based Government 154 0.5% 0.4% -0.3% 1.8% 2.4% 

Subtotal: Freestanding 8 710 0.0% 0.0% -0.1% 1.8% 1.7% 

Subtotal: Facility-based 691 0.5% -0.1% -0.2% 1.8% 2.0% 

Subtotal: Vol/NP 1426 0.5% -0.3% -0.1% 1.8% 1.9% 

Subtotal: Pronrietarv 7 638 -0.2% 0.1% -0.1% 1.8% 1.6% 

Subtotal: Government 337 0.6% 0.3% -0.3% 1.8% 2.4% 

Facility Type and Control: Rural 

Free-Standing/Other Vol/NP 224 0.3% -0.1% -0.7% 1.8% 1.3% 

Free-Standing/Other Proprietarv 798 -0.2% 0.0% -0.3% 1.8% 1.3% 

Free-Standing/Other Government 122 0.8% 0.2% -0.8% 1.8% 2.0% 

Facility-Based Vol/NP 216 0.6% -0.1% -0.7% 1.8% 1.6% 

Facility-Based Pronrietarv 19 0.3% -0.3% -0.6% 1.8% 1.2% 

Facility-Based Government 114 0.5% 0.5% -0.6% 1.8% 2.2% 

Facility Type and Control: Urban 

Free-Standing/Other Vol/NP 715 0.4% -0.3% 0.0% 1.8% 1.9% 

Free-Standing/Other Proprietarv 6,790 -0.2% 0.1% 0.0% 1.8% 1.7% 

Free-Standing/Other Government 61 0.7% 0.1% -0.1% 1.8% 2.5% 

Facility-Based Vol/NP 271 0.6% -0.1% -0.1% 1.8% 2.2% 

Facility-Based Pronrietarv 31 0.3% 0.2% 0.0% 1.8% 2.3% 

Facility-Based Government 40 0.4% 0.3% 0.0% 1.8% 2.5% 

Facility Location: Urban or Rural 

Rural 1493 0.0% 0.0% -0.4% 1.8% 1.4% 

Urban 7 908 0.0% 0.0% 0.0% 1.8% 1.8% 

Facility Location: Region of the 

Countrv (Census Rel!ion) 

New England 323 0.3% -0.7% -0.1% 1.8% 1.3% 

Mid Atlantic 428 0.8% -0.6% -0.1% 1.8% 1.9% 

East North Central L588 0.0% -0.2% -0.2% 1.8% 1.4% 

West North Central 618 0.3% 0.2% -0.3% 1.8% 2.0% 

South Atlantic 1,530 0.3% 0.5% -0.1% 1.8% 2.5% 

East South Central 370 -0.1% -0.6% -0.1% 1.8% 1.0% 

West South Centrnl 2,219 -0.3% -0.3% 0.0% 1.8% 1.2% 

Mountain 674 -0.1% 0.0% -0.1% 1.8% 1.6% 

Pacific 1,609 -0.6% 0.5% 0.0% 1.8% 1.7% 

Outlying 42 0.7% -1.4% -0.4% 1.8% 0.7% 

Facility Size (Number of 30-day 

Periods) 

< 100 periods 1,998 0.2% 0.0% -0.1% 1.8% 1.9% 

100 to 249 1,512 -0.2% 0.0% -0.1% 1.8% 1.5% 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35993 

2. Impacts for the Expanded HHVBP 

Model 

Based on proposals discussed in 

section III.A. of this proposed rule, 

Tables G6 and G7 display our analysis 

of the distribution of possible payment 

adjustments using 2019 data as the 

performance year, while Table 39 

provides information on the estimated 

impact of this proposed expansion. We 

note that this impact analysis is based 

on the aggregate value of savings 

associated with all Medicare-certified 

HHAs in each State, territory, and the 

District of Columbia. 

Value-based incentive payment 

adjustments for the estimated 7,500-plus 

HHAs that would qualify to compete in 

the proposed HHVBP Model expansion 

based on the CY 2019 data stratified by 

size, as defined in section III.F. of this 

proposed rule. For example, Table 40 

shows California has 69 HHAs that do 

not provide services to enough 

beneficiaries to be required to complete 

HHCAHPS surveys, and therefore, 

would be considered to be in the 

smaller-volume cohort under the 

proposed Model expansion. Using 2019 

performance year data and the proposed 

payment adjustment of 5-percent, based 

on 8 outcome measures, the smallervolume HHAs in California would have 

a mean payment adjustment of positive 

0.042 percent. Only 10-percent of home 

health agencies would be subject to 

downward payment adjustments of 

more than minus 3.139 percent (¥3.139 

percent). The next columns provide the 

distribution of scores by percentile. We 

see that the value-based incentive 

percentage payments for smaller-volume 

home health agencies in California 

range from ¥3.139 percent at the 10th 

percentile to +3.899 percent at the 90th 

percentile, while the value-based 

incentive payment at the 50th percentile 

is ¥0.607 percent. The smaller-volume 

HHA cohort table identifies that some 

locations do not have any qualifying 

HHAs in the smaller-volume cohort, 

including Connecticut, the District of 

Columbia, and Delaware. 

The next columns provide the 

distribution of scores by percentile. We 

see that the value-based incentive 

percentage payments for smaller-volume 

home health agencies in California 

range from ¥3.139 percent at the 10th 

percentile to +3.899 percent at the 90th 

percentile, while the value-based 

incentive payment at the 50th percentile 

is ¥0.607 percent. 

The smaller-volume HHA cohort table 

identifies that some locations do not 

have any qualifying HHAs in the 

smaller-volume cohort, including 

Connecticut, the District of Columbia, 

and Delaware. 

Table 41 provides the payment 

adjustment distribution based on 

proportion of dual eligible beneficiaries, 

average case mix (using HCC scores), 

proportion that reside in rural areas, as 

well as HHA organizational status. To 

define cutoffs for the ‘‘percentage of 

dual eligible beneficiaries,’’ low, 

medium, or high percentage dualeligible are based on less than the 25th 

percentile, between the 25th and 75th 

percentiles, and greater than the 75th 

percentile of percent dual eligible 

beneficiaries, respectively, across HHAs 

in CY 2019. To define case mix cutoffs, 

low, medium, or high acuity are also 

based on less than the 25th percentile, 

between the 25th and 75th percentiles, 

and greater than the 75th percentile of 

average HCC scores, respectively, across 

HHAs in CY 2019. To define cutoffs for 

percentage of rural beneficiaries, all 

non-rural, up to 50 percent rural, and 

over 50 percent rural are based on the 

home health beneficiaries’ core-based 

statistical area (CBSA) urban versus 

rural designation. We would note that, 

based on 2019 data, a higher proportion 

of dually-eligible beneficiaries served is 

associated with better performance. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.058</GPH>

CY2022 

Case-Mix Proposed 

Weights HH 

Number Recalibration CY2022 CY2022 Payment 

of Neutrality Updated Rural Update 

A2encies Factor Wa2elndex Add-On Percenta2e 

250 to 499 1,711 -0.3% 0.1% -0.1% 1.8% 

500 to 999 1887 -0.3% 0.1% -0.1% 1.8% 

1000 or More 2 293 0.1% -0.1% -0.1% 1.8% 

Source: CY 2020 Medicare claims data for periods with matched OASIS records (only) starting and ending in 

CY2020 (as of Mar 15, 2021). 

REGION KEY: 

New England=Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont 

Middle Atlantic=Pennsylvania, New Jersey, New York; 

South Atlantic=Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, 

Virginia, West Virginia 

East North Central=Illinois, Indiana, Michigan, Ohio, Wisconsin 

East South Central=Alabama, Kentucky, Mississippi, Tennessee 

West North Central=Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota 

West South Central=Arkansas, Louisiana, Oklahoma, Texas 

Mountain=Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming 

Pacific= Alaska, California, Hawaii, Oregon, Washington 

Other=Guam, Puerto Rico, Virgin Islands 

Total 

1.5% 

1.5% 

1.7% 
35994 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.059</GPH> EP07JY21.060</GPH>

TABLE 39. ESTIMATED GROSS FFS SAVINGS UNDER EXPANDED HHVBP 

MODEL CYs 2022-2026 

CY 2022 CY 2023 CY 2024 CY 2025 CY 2026 

$334,000,000 $674,000,000 $670,000,000 $713,000,000 $761,000,000 

TABLE 40: HHA COHORT PAYMENT ADJUSTMENT DISTRIBUTIONS 

(Based on a maximum 5 percent payment adjustment) 

Smaller-volume Cohort 

Average Payment Adjustment Percentile Distribution(%) 

Payment 

#of Adjustment 

State HHAs (%) 10% 20% 30% 40% 50% 60% 70% 80% 

AK 1 (0.646) (0.646) (0.646) (0.646) (0.646) (0.646) (0.646) (0.646) (0.646) 

AL 1 1.601 1.601 1.601 1.601 1.601 1.601 1.601 1.601 1.601 

AR 2 0.794 (2.454) (2.454) (2.454) (2.454) 0.794 4.041 4.041 4.041 

AZ, 2 0.710 (2.446) (2.446) (2.446) (2.446) 0.710 3.866 3.866 3.866 

CA 69 0.042 (3.139) (2.503) (1.748) (1.495) (0.607) 0.878 1.586 2.605 

co 4 0.127 (2.367) (2.367) 0.445 0.445 0.572 0.698 0.698 1.733 

CT 0 

DC 0 

DE 0 

FL 51 0.756 (3.080) (1.928) (1.016) (0.014) 0.612 1.482 3.336 3.935 

GA 0 

GU 0 

HI 0 

IA 7 (0.840) (2.816) (1.831) (1,641) (1.641) 0.422) (1.096) (1.096) (0.082) 

ID 1 (2.206) (2.206) (2.206) (2.206) (2.206) (2.206) (2.206) (2.206) (2.206) 

IL 61 0.652 (3.275) (2.451) 0.614) (0.772) 1.170 1.856 2.794 3.627 

IN 11 0.596 (2.821) (1.241) (0.390) 0.683 0.729 1.028 1.367 2.944 

KS 4 0.321 (3.256) (3.256) 0.255) (1.255) 0.Q31 1.317 1.317 4.476 

KY 0 

LA 0 

MA 5 (0.709) (4.469) (4.107) (3.744) (2.321) (0.898) 0.489 1.876 2.784 

MD 2 0.345 (2.576) (2.576) (2.576) (2.576) 0.345 3.265 3.265 3.265 

ME 1 (2.179) (2.179) (2.179) (2.179) (2.179) (2.179) (2.179) (2.179) (2.179) 

MI 52 0.896 (2.662) (2.081) (0.494) 0.397 1.011 1.790 2.787 3.255 

MN 7 (2.227) (4.577) (4.453) (3.677) (3.677) (3.244) (0.514) (0.514) (0.480) 

MO 7 (1.996) (4.370) (3.431) (3.223) (3.223) (2.419) (2.106) (2.106) 0.176 

MP 0 

MS 0 

MT 2 2.049 (0.847) (0.847) (0.847) (0.847) 2.049 4.944 4.944 4.944 

NC 4 (0.681) (2.371) (2.371) (1.204) (1.204) (0.473) 0.259 0.259 0.592 

ND 0 

NE 8 (0.751) (4.403) (3.062) (2.029) (0.282) (0.165) (0.047) 0.750 1.211 

NH 1 (4.501) (4.501) (4.501) (4.501) (4.501) (4.501) (4.501) (4.501) (4.501) 

NJ 0 

NM 3 0.394 (1.562) (1.562) (1.562) (0.746) (0.746) (0.746) 3.490 3.490 

NV 8 (0.691) (3.671) (3.033) (1.997) (1.029) (0.905) (0.780) (0.181) 0.164 

NY 0 

OH 8 (2.409) (4.307) (4.178) (3.890) (3.739) (3.618) (3.497) (1.041) (0.905) 

OK 8 (2.008) (4.351) (3.004) (2.942) (2.347) (2.068) (1.788) (1.747) 0.042 

90% 

(0.646) 

1.601 

4.041 

3.866 

3.899 

1.733 

5.000 

3.009 

(2.206) 

5.000 

3.059 

4.476 

3.692 

3.265 

(2.179) 

4.814 

1.359 

1.399 

4.944 

0.592 

1.851 

(4.501) 

3.490 

5.000 

2.286 

0.076 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35995 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.061</GPH>

Smaller-volume Cohort 

Average Payment Adjustment Percentile Distribution (%) 

Payment 

#of Adjustment 

State HHAs (%) 10% 20% 30% 40% 50% 60% 70% 80% 90% 

OR 1 (0.938) (0.938) (0.938) (0.938) (0.938) (0.938) (0.938) (0.938) (0.938) (0.938) 

PA 9 (l.965) (4.263) (4.023) (3.537) (3.056) (2.969) (l.039) (0.725) 0.543 1.385 

PR 0 

Rl 0 

SC 0 

SD 4 (1.081) (3.754) (3.754) (2.073) (2.073) (1.170) (0.267) (0.267) 1.770 1.770 

TN I (I. 921) (1.921) (1.921) (1.921) (1.921) (1.921) (1.921) (1.921) (1.921) (1.921) 

TX 85 (0.727) (4.121) (3.224) (2.548) (1.714) (0.565) 0.303 0.875 1.215 2.576 

UT 6 0.244 (1.724) (1.517) (1.517) (0.461) (0.115) 0.231 1.618 1.618 3.319 

VA 5 0.794 (4.066) (1.925) 0.216 0.860 1.504 1.864 2.223 3.158 4.093 

V1 0 

VT 0 

WA 0 

W1 0 

WV 0 

WY 2 (1.247) (2.474) (2.474) (2.474) (2.474) (1.247) (0.020) (0.020) (0.020) (0.020) 

All 443 (0.079) (3.677) (2.703) (1.967) (1.141) (0.267) 0.635 1.413 2.621 3.975 

Lar~er-volume Cohort 

Average Pavment Adiustment Percentile Distribution(%) Payment 

#of Adjustment 

State HHAs (%) 10% 20% 30% 40% 50% 60% 70% 80% 90% 

AK 12 (0.627) (3.202) (2.588) (2.199) (1.448) (1.007) (0.774) 1.275 1.423 1.897 

AL 114 1.632 (1.583) (0.520) 0.510 1.110 1.856 2.392 3.058 3.833 4.653 

AR 90 1.114 (1.830) (1.158) (0.185) 0.854 1.403 2.060 2.643 3.090 4.097 

AZ 106 0.441 (2.830) (2.073) (1.522) (0.188) 0.547 1.077 1.774 2.880 4.504 

CA 991 0.799 (2.856) (1.930) (1.130) (0.306) 0.381 1.528 2.710 4.200 5.000 

co 104 0.059 (3.260) (2.293) (1.588) (0.912) (0.219) 0.392 1.246 1.946 4.482 

CT 74 (0.829) (3.321) (2.908) (2.511) (1.846) (1.481) (0.390) 0.059 1.206 2.448 

DC 7 (0.428) (3.672) (2.455) (1.306) (1.306) (0.938) 0.289 0.289 0.767 4.319 

DE 12 0.141 (2.604) (1.897) (1.874) (1.282) (0.076) 0.965 1.626 2.274 2.798 

FL 676 0.933 (2.436) (1.416) (0.655) 0.139 0.760 1.471 2.448 3.530 5.000 

GA 99 (0.021) (2.516) (1.652) (1.037) (0.654) (0.186) 0.435 0.966 1.653 2.274 

GU 3 ( 1.612) (1.897) (1.897) (1.897) (1.703) (1.703) (1.703) (1.236) (1.236) (1.236) 

HI 14 0.760 (2.334) (2.053) (0.805) 0.284 1.318 1.711 2.149 2.998 4.064 

IA 94 0.344 (2.920) (2.173) (1.254) (0.604) 0.638 1.208 1.865 2.880 3.762 

ID 42 0.245 (2.673) (2.309) (0.645) (0.236) 0.o28 0.865 1.383 2.297 3.059 

IL 398 0.407 (2.854) (2.065) (1.441) (0.656) (0.008) 0.823 1.873 3.137 5.000 

IN 138 (0.149) (3.068) (2.166) (1.455) (0.890) (0.452) 0.226 0.991 1.629 3.179 

KS 84 0.252 (3.170) (1.706) (1.103) (0.348) 0.131 0.675 1.328 2.425 3.665 

KY 90 0.990 (2.331) (0.892) (0.404) 0.332 0.781 1.381 2.258 3.365 4.290 

LA 167 1.333 (1.902) (0.762) 0.o78 0.597 1.367 2.234 2.865 3.746 4.840 

MA 127 (0.162) (2.991) (2.207) (1.508) (0.943) (0.091) 0.356 0.752 1.582 2.980 

MD 49 0.823 (1.649) (1.207) (0.831) (0.260) 0.298 1.769 2.378 2.867 4.019 

ME 19 1.081 (1.718) (0.501) 0.039 0.505 0.704 0.917 2.069 2.862 4.562 

MI 322 0.802 (2.660) (1.818) (1.197) (0.270) 0.657 1.634 2.672 3.671 5.000 

MN 97 (0.799) (3.469) (2.791) (2.154) (1.559) (1.130) (0.629) (0.127) 1.lll 2.747 

MO 122 0.512 (2.814) (2.014) (1.458) (0.482) 0.222 1.345 2.042 3.280 4.334 

MP 1 (0.515) (0.515) (0.515) (0.515) (0.515) (0.515) (0.515) (0.515) (0.515) (0.515) 

MS 45 1.325 (1.351) (0.689) (0.102) 0.776 1.448 2.121 2.718 3.370 4.414 

MT 22 (0.839) (3.220) (2.745) (1.807) (1.760) (1.373) (0.874) (0.009) 0.957 1.328 
35996 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

BILLING CODE 4120–01–C 

3. Impacts for the HH QRP for CY 2022 

Estimated impacts for the HH QRP are 

based on analysis discussed in section 

X.B. of this proposed rule. The proposed 

HH QRP requirements would reduce 

burden to the active collection under 

OMB control number #0938–1279 

(CMS–10545; expiration 12/31/21). 

Failure to submit data required under 

section 1895(b)(3)(B)(v) of the Act with 

respect to a calendar year will result in 

the reduction of the annual home health 

market basket percentage increase 

otherwise applicable to an HHA or that 

calendar year by 2 percentage points. 

For the CY 2021, 527 of the 11,196 

active Medicare-certified HHAs, or 

approximately 4.7 percent, did not 

receive the full annual percentage 

increase (the methodology 

accommodated the COVID–19 PHE 

exception). These 527 HHAs 

represented $253 million in home 

health claims payment dollars during 

the reporting period compared out of a 

total $16.7B for all HHAs. 

As discussed in section IV.C. of this 

proposed rule, we are proposing to 

remove one OASIS-based measure 

beginning with the CY 2023 HH QRP. 

The assessment-based measure we are 

proposing to remove is: (1) Drug 

Education on All Medications Provided 

to Patient/Caregiver during All Episodes 

of Care. We are also proposing to 

replace the Acute Care Hospitalization 

During the First 60 Days of Home Health 

(NQF #0171) measure and Emergency 

Department Use Without 

Hospitalization During the First 60 Days 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.062</GPH> EP07JY21.063</GPH>

TABLE 41: PAYMENT ADJUSTMENT DISTRIBUTIONS BY CHARACTERISTICS 

(Based on a maximum 5 percent payment adjustment) 

Pavment Adiustment Percentile Distribution(%) 

Average 

Percentage of Dually- #of Payment 10% 20% 30% 40% 50% 60% 70% 80% eligible Beneficiaries HHAs Adjustment 

(%) 

Low% duallv-elilrible 2 061 0.464 (2.592) (1.656) (0.970) (0.313) 0.295 0.991 1.658 2.618 

Medium% duallv-elilrible 4118 0.153 (2.962) (2.134) (1.447) (0.774) (0.051) 0.662 1.446 2.425 

Hieh % duallv-elilrible 1316 1.066 (3.145) (1.943) (1.043) 0.200 1.059 2.226 3.327 4.710 

Average 

Acuity (HCC) #of Payment 10% 20% 30% 40% 50% 60% 70% 80% HHAs Adjustment 

(%) 

Low acuity 1479 1.283 (2.545) (1.426) (0.457) 0.435 1.275 2.276 3.265 4.451 

Middle acuity 4 290 0.320 (2.756) (1.905) (1.247) (0.560) 0.187 0.851 1.604 2.601 

Hiehacuitv 1 726 (0.162) (3.283) (2.446) (1.753) (1.143) (0.460) 0.255 1.081 2.104 

Average 

% Rural Beneficiaries #of Payment 10% 20% 30% 40% 50% 60% 70% 80% HHAs Adjustment 

(%) 

All non-rural 3 849 0.483 (2.969) (2.046) (1.318) (0.552) 0.266 1.099 2.020 3.249 

Uo to 50% rural 2,265 0.024 (2.873) (2.089) (1.438) (0.822) (0.140) 0.469 1.200 2.108 

Over 50% rural 1,368 0.783 (2.408) (1.539) (0.672) 0.066 0.819 1.390 2.214 3.121 

Average 

Organizational Type #of Payment 10% 20% 30% 40% 50% 60% 70% 80% HHAs Adjustment 

(%) 

Relilrious affiliation 289 0.085 (2.658) (1.807) (1.294) (0.794) (0.252) 0.465 1.123 2.062 

Private not-for-orofit 579 (0.010) (2.961) (2.053) (1.432) (0.891) (0.262) 0.422 1.098 2.055 

Other not-for-profit 478 0.230 (2.618) (1.812) (1.144) (0.470) 0.160 0.752 1.314 2.296 

Private for-profit 5,869 0.459 (2.913) (1.997) (1.271) (0.500) 0.278 1.044 1.918 3.039 

State 186 0.548 (3.244) (1.790) (0.699) (0.225) 0.441 1.317 2.151 3.047 

Gov't & voluntarv 10 1.059 (0.356) (0.171) 0.073 0.322 0.879 1.395 1.565 1.618 

Local 96 0.583 (2.604) (1.584) (0.797) (0.102) 0.507 1.361 1.834 2.749 

Note: The total number ofHHAs differ by category due to missmg HHAs m some data sources. 

TABLE 42: BURDEN SAVINGS CALCULATIONS 

90% 

3.889 

3.832 

5.000 

90% 

5.000 

3.913 

3.545 

90% 

5.000 

3.323 

4.414 

90% 

3.232 

3.562 

3.280 

4.677 

4.263 

3.134 

3.799 

Time Point Costs with 2020 data Removal of M2016 Estimate Cost 

Transfer of Care $4,969,755.73 $4,259,790.63 $709,965 

Discharge from agency $230,885,202.34 $228,832,890.59 $2,052,312 

2,762,277 

$242perHHA 

TOTAL (2,762,277 /11,400) 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35997 

of Home Health (NQF #0173) measure 

with the Home Health Within Stay 

Potentially Preventable Hospitalization 

measure beginning with the CY 2023 

HH QRP under our measure removal 

Factor 6: A measure that is more 

strongly associated with desired patient 

outcomes for the particular topic is 

available. Because these three measures 

are claims-based, there will be no 

impact to our collection of information. 

Section X.B. of this proposed rule 

provides a detailed description of the 

net decrease in burden associated with 

these proposed changes. The associated 

burden is for CY 2023 because HHAs 

will be able to submit data beginning CY 

2023. The cost impact related to OASIS 

item collection as a result of the changes 

to the HH QRP is estimated to be a net 

decrease of $2,762,277 in annualized 

cost to HHAs, discounted at 7 percent 

relative to year 2020, over a perpetual 

time horizon beginning in CY 2023. 

We describe the estimated burden and 

cost reductions for these measures in 

section X.B of this rule. 

In summary, the proposed HH QRP 

measure removals would result in a 

burden reduction of $242 per HHA 

annually, or $2,762,277 for all HHAs 

annually. We have described the burden 

costs savings in Table 42: 

4. Changes to the Home Health CoPs 

a. Virtual Supervision of HHA Aides 

In section IV.D. of this rule, we 

propose to revise the CoPs for home 

health agencies. Specifically, in section 

IV.D. of this rule, we propose to revise 

the home health aide supervision 

requirements to allow for virtual 

supervision. The burden may be 

reduced for providers by improving the 

efficiency of the training and 

supervision of home health aides. We 

are also adding the requirement that the 

skills related to any deficient skills be 

addressed. We believe the burden 

associated with addressing skills related 

to those identified as deficient skills is 

minimal. Moreover, supervising 

employees to ensure the safe and 

effective provision of patient care is 

standard business practice throughout 

the health care community. Likewise, 

documenting that this supervision has 

occurred for internal personnel, 

accreditation, and State and Federal 

compliance purposes constitutes a usual 

and customary business practice. 

Therefore, the regulatory impact is 

negligible. 

b. Permitting Occupational Therapists 

To Conduct the Initial Assessment Visit 

and Complete the Comprehensive 

Assessment for Home Health Agencies 

Under the Medicare Program 

In accordance with Division CC, 

section 115 of CAA 2021, we are 

proposing conforming regulations text 

changes to permit the occupational 

therapist to complete the initial and 

comprehensive assessments for 

Medicare patients when ordered with 

another rehabilitation therapy service 

(speech language pathology or physical 

therapy) that establishes program 

eligibility, in the case where skilled 

nursing services are also not ordered. 

We do not expect any increase in 

burden for any of these modifications. 

In fact, for home health agencies, 

burden may be reduced by expanding 

the type of therapy discipline able to 

complete the initial and comprehensive 

assessments, in some circumstances, for 

Medicare patients. We do not expect the 

changes for these provisions will cause 

any appreciable amount of expense or 

anticipated saving and we do not 

believe this standard would impose any 

additional regulatory burden. 

5. Payment for Home Infusion Therapy 

Services 

There are two new proposals in this 

rule related to payments for home 

infusion therapy services in CY 2022: 

The proposal to maintain the CY 2021 

percentages for the initial subsequent 

policy and the proposal to wage adjust 

HIT service payments using the CY 2022 

GAFs Adjustments to the home infusion 

therapy payment rates will be made 

when the CY 2022 final GAF values 

become available and will be budget 

neutral using the GAF standardization 

factor. The CY 2021 home infusion 

therapy service payments will also be 

updated by the CPI–U reduced by the 

productivity adjustment. The CY 2022 

final GAF values (and the CPI–U as of 

June 2021) were not available at the 

time of rulemaking, therefore, we are 

unable to estimate the impact of these 

adjustments on the CY 2022 HIT service 

payment amounts compared to the CY 

2021 HIT service payment amounts. We 

will outline the home infusion therapy 

payment impacts in the CY 2022 HH 

PPS final rule. 

6. Medicare Provider and Supplier 

Enrollment Provisions 

a. General Impact 

Similar to our position regarding 

information collection requirements, 

and except as stated in section XI.C.6.b. 

of this proposed rule, we do not 

anticipate any costs, savings, or 

transfers associated with our provider 

and supplier enrollment proposals. 

Most of these proposals have been in 

subregulatory guidance for a number of 

years, and we are merely incorporating 

them into regulation; those proposed 

provisions that are not in subregulatory 

guidance do not involve any costs, 

savings, or transfers. 

b. Deactivation of Billing Privileges— 

Payment Prohibition 

As explained in section VI.B of this 

proposed rule, we are proposing in new 

§ 424.540(e) that a provider or supplier 

may not receive payment for services or 

items furnished while deactivated under 

§ 424.540(a). Existing subregulatory 

guidance permits the provider or 

supplier to bill for services or items 

furnished up to 30 days prior to the 

effective date of the reactivation of the 

provider’s or supplier’s billing 

privileges. Our proposal would reverse 

this policy for the reasons stated in 

section VI.B. of this proposed rule. 

Although the figure varies widely by 

individual provider or supplier, internal 

CMS data suggests that the average 

provider/supplier impacted by this 

proposal receives roughly $50,000 in 

Medicare payments each year. (We used 

a similar $50,000 annual payment 

estimate for our provider enrollment 

provisions in a CMS final rule 

published in the Federal Register on 

November 15, 2019 titled, ‘‘CY 2020 

Revisions to Payment Policies under the 

Physician Fee Schedule and Other 

Changes to Part B Payment Policies’’) 

(84 FR 62568). As with annual payment 

amounts, the number of deactivations 

vary per year. Nonetheless, and based 

on internal CMS data, we estimate 

13,000 deactivations annually. This 

results in an approximate burden of 

$54,145,000 per year (13,000 × 50,000 × 

0.0833). (The 0.0833 figure represents 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.064</GPH>

PROHIBITION OF PAYMENT FOR SERVICES OR ITEMS FURNISHED BY 

DEACTIVATED PROVIDERS AND SUPPLIERS FROM CY 2021 TO 2022 

Providers/Suppliers to Federal Government I $54.1 million 
35998 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

30 days, or 1/12 of a year.) The 

following table reflects the estimated 

transfers associated with our proposed 

addition of new § 424.540(e) concerning 

payments for services and items 

furnished by deactivated providers and 

suppliers: 

7. Survey and Enforcement 

Requirements for Hospice Providers 

Estimated impacts for the Survey and 

Certification Requirements for Hospice 

Program Providers are based on analysis 

discussed in section VII. of this 

proposed rule. 

a. Application and Re-Application 

Procedures for National Accrediting 

Organizations (§ 488.5) 

We proposed at § 488.5(a)(4)(x) to 

require AOs with CMS-approved 

hospice programs to include a statement 

of deficiencies, (that is, the Form CMS– 

2567 or a successor form) to document 

survey findings of the hospice Medicare 

CoPs and to submit such in a manner 

specified by CMS. This implements new 

section 1822(a)(2)(A)(ii) of the Act. We 

anticipate effects on AO administrative 

expenses but are not able to provide an 

accurate estimate of how much cost and 

time will result from including the Form 

CMS–2567 into their proprietary IT 

systems and subsequently submitting 

the information to CMS. Currently, there 

are three AOs with CMS-approved 

hospice programs affected by this 

proposal. We seek comments that would 

help us to develop an accurate estimate 

of the cost and time burden that would 

result from this collection of 

information. 

b. Release and Use of Accreditation 

Surveys (§ 488.7) 

CAA 2021 adds section 1822(a)(2)(B) 

of the Act which requires that CMS 

publish hospice survey information 

from the Form CMS–2567 in a way that 

is readily understandable and useable 

by the public in a meaningful way. We 

anticipate the need for CMS to develop 

some type of a standard framework that 

would identify salient survey findings 

in addition to other relevant data about 

the hospices’ performance. CMS 

recognizes that the implications of 

releasing national survey data will 

require collaboration with industry 

stakeholders to assure the development 

is fair and equitable across all hospice 

programs. 

c. Hospice Hotline (§ 488.1110) 

Section 1864(a) of the Act was 

amended by inserting ‘‘hospice 

programs’’ after information on the 

home health toll-free hotline. The 

infrastructure for a State or local agency 

toll-free hotline is already in place for 

HHAs to collect and maintain complaint 

information related to HHAs. The 

requirement allows the existing hotline 

to collect complaint information on 

hospices. We do not expect the changes 

for this provision will cause any 

appreciable amount of expense or 

anticipated saving and we do not 

believe this standard would impose any 

additional regulatory burden. 

d. Surveyor Qualifications and 

Prohibition of Conflicts of Interest 

(§ 488.1115) 

We propose at § 488.1115, to require 

AO hospice program surveyors to 

complete the CMS hospice basic 

training currently available online. The 

hospice basic training course has an 

average completion time of 24 hours. 

Completion time could be more or less 

depending upon the learner’s familiarity 

with the content and overall learning 

style. We are not able to estimate 

precisely total time and cost burden to 

each AO for the wages incurred for the 

time spent by all surveyors from each of 

the three hospice program AOs to take 

the CMS online surveyor training 

course, because each AO varies greatly 

in organization size, number of 

accreditation programs approved by 

CMS, and total surveyor cadre numbers. 

There are no regulatory requirements for 

AOs to report to CMS on the number of 

surveyors within their organization nor 

information on how many of those 

surveyors survey each type of program 

approved by CMS. CMS notes there is 

a wide variety of total surveyor cadre 

numbers across all three AOs, based on 

information CMS has gathered from 

confidential numbers, voluntarily 

provided by some of the AOs to CMS, 

as part of their deeming authority 

application documents as well as 

information found online via a search of 

each AOs public website. Variation is 

generally based on the associated 

number of CMS-approved accreditation 

programs the AO possesses. For 

example, AOs who accredit only one 

provider or supplier type generally have 

about 25 surveyors while AOs with 

multiple programs have surveyor 

numbers well over 300 thereby skewing 

the ability to estimate an accurate time 

burden that represents the overall 

group. Because of this wide range CMS 

is estimating near the middle, using the 

range of 100 total surveyors per AO. If 

we estimate that each AO has 

approximately 100 total surveyors, the 

estimated time burden to each AO 

associated with this requirement would 

be 2,400 hours (24 hours × 100 

surveyors). 

The estimated cost burden to each AO 

with CMS-approved hospice programs 

associated with this requirement would 

be $184,656 (2,400 hours × $76.94 per 

hour (based on the salary of a registered 

nurse. See Table 37)). 

As of March 2021, there are three AOs 

that accredit Medicare-certified hospice 

programs. We estimate that the time 

burden across all of these AOs 

associated with the requirement that 

their surveyors take the CMS online 

surveyor training would be 7,200 hours 

(2,400 hours × 3 AOs). The estimated 

cost across all AOs (that accredit 

Medicare-certified hospice programs) 

would be $553,968 ($184,656 × 3 AOs). 

We also proposed to set out the 

circumstances that will disqualify a 

surveyor from surveying a particular 

hospice in accordance with new section 

1822(a)(4)(B) of the Act). We do not 

expect these proposed changes will 

cause any appreciable amount of 

expense or anticipated saving because 

the provisions codify longstanding 

policies and basic principles to ensure 

there is no conflict of interest between 

organizations and surveyors. 

e. Survey Teams (§ 488.1120) 

We propose at § 488.1120 that when 

the survey team comprises more than 

one surveyor, the additional slots would 

be filled by multidisciplinary 

professionals such as physicians, 

nurses, medical social workers, pastoral 

or other counselors—bereavement, 

nutritional, and spiritual. At this time, 

we do not have specific information 

related to current survey team 

compositions but we do know there are 

approximately 977 hospice surveys per 

year, with at least one member of the 

survey team being a registered nurse. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.064</GPH>

PROHIBITION OF PAYMENT FOR SERVICES OR ITEMS FURNISHED BY 

DEACTIVATED PROVIDERS AND SUPPLIERS FROM CY 2021 TO 2022 

Providers/Suppliers to Federal Government I $54.1 million 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 35999 

The proposed inclusion of 

multidisciplinary survey team members 

could potentially increase the overall 

cost of surveys if SA and AOs were not 

already using a mixed team. 

The 2020 Bureau of Labor Statistics 

estimates RN adjusted hourly wages at 

$76.94 (including fringe benefits and 

overhead). Other potential disciplines 

fall below and above the RN adjusted 

hourly wage, for example: Social 

workers—$50.12 per hour, 

pharmacists—$120.64 per hour, and 

psychologists—$108.36 per hour. A 

survey team of all nurses (assuming a 

two-person team) costs $153.88 ($76.94 

× 2) per hour. However, CMS believes 

the most common multidisciplinary 

team for hospice program surveys may 

include a nurse and a social worker. 

Using this assumption, we calculate it 

will cost $127.06 ($76.94 + $50.12) per 

hour for this multidisciplinary 2-person 

survey team composition. Therefore, a 

two-person multidisciplinary team at 

$127.06 per hour, assuming a 5-day 

survey (8 hours per day × 5 days = 40 

hours), would cost $5,082.40 per survey, 

times 960 surveys per year, or 

$4,879,104 per year. We seek comments 

on the current professional makeup of 

the AO and SA survey teams, and 

providers’ estimates of the time needed 

to effectuate multidisciplinary teams 

where they do not currently exist. 

f. Consistency of Survey Results 

(§ 488.1125) 

Actions to improve consistency of 

survey results are discussed elsewhere 

in terms of implementing the use of the 

Form CMS–2567 across surveying 

entities and utilizing a common training 

platform. We do not anticipate 

additional costs or burdens to surveying 

entities. Some cost will be incurred by 

CMS to develop the system (technical 

and personnel) to analyze and apply 

correction where needed. 

g. Special Focus Program (§ 488.1130) 

There may be an additional SA 

burden in terms of the need for 

enhanced survey and enforcement 

activities which is in part why a more 

methodical and targeted approach to the 

implementation of this program should 

be considered given the allocation of 

$10 million to support this and the 

other provisions that would not begin 

until FY 2022. 

h. Enforcement Remedies (§§ 488.1200 

Through § 488.1265) 

We propose enforcement remedies for 

hospices consistent with the established 

alternative sanctions for HHAs. In CY 

2019, out of 11,738 deemed and nondeemed HHAs enrolled in the Medicare 

program, 749 HHA providers had the 

potential to be sanctioned based on 

repeat deficiencies during two 

consecutive standard or complaint 

surveys. This was approximately 15 

percent of the HHAs, which is less than 

37.5 percent of the total HHAs surveyed. 

Of all the alternative sanctions available 

for implementation, very few HHA 

enforcement actions were imposed. In 

CY 2019, less than 10 percent of all 

HHAs with surveys identifying an 

immediate jeopardy level deficiency 

citation received an alternative sanction. 

The probability of impact for 

alternative enforcement remedies 

imposed against hospices is based on 

CY 2019 data for 5,065 deemed and 

non-deemed hospices enrolled in the 

Medicare program. This data was 

examined using the survey data for the 

CY 2019 in the CMS QCOR system. Of 

the total number of CMS-certified 

hospices, 4,399 received an 

unannounced standard and/or 

complaint survey and 236 were cited for 

noncompliance with one or more 

condition-level deficiencies. Therefore, 

approximately 5 percent of the total 

hospices surveyed had the potential to 

receive an enforcement remedy based 

on noncompliance with one or more 

CoPs. 

The enforcement remedy provisions 

in this proposed rule mirror the 

alternative sanctions used in HHAs that 

have already been incorporated into 

CMS policy. Therefore, in terms of the 

administrative expenses to design and 

manage these types of remedies, the 

infrastructure is already in place. In 

terms of training for Federal and State 

surveyors, it is common for surveyors 

that survey HHAs to be cross-trained to 

survey hospices. Since the enforcement 

remedies for hospice are similar to those 

for HHAs, we expect that there will be 

a minimal burden on seasoned 

surveyors to become familiar with these 

provisions. Additionally, the data 

analysis described previously for 

hospices in CY 2019 reflects the 

probability of a low impact for civil 

monetary penalties to be imposed on 

hospice providers. 

8. Certain Compliance Date Changes for 

the IRF QRP and LTCH QRP 

a. Impacts for the Inpatient 

Rehabilitation Facility Quality 

Reporting Program for FY 2023 

This proposed rule would not impose 

any new information collection 

requirements. However, this proposed 

rule does reference associated 

information collections that are not 

discussed in the regulation text 

contained in this document. The 

following is a discussion of this 

information collection, which have 

already received OMB approval. 

In accordance with section 

1886(j)(7)(A) of the Act, the Secretary 

must reduce by 2 percentage points the 

annual market basket increase factor 

otherwise applicable to an IRF for a 

fiscal year if the IRF does not comply 

with the requirements of the IRF QRP 

for that fiscal year. As stated in section 

VIII.A. of this proposed rule for 

purposes of calculating the FY 2023 

Annual Increase Factor (AIF), we 

propose that IRFs would begin using the 

IRF–PAI V4.0 to collect data on the TOH 

Information to Provider-PAC and the 

TOH Information to Patient-PAC 

measures beginning with admissions 

and discharges on October 1, 2022. We 

also proposed that IRFs would begin to 

use the IRF–PAI V4.0 to collect data on 

certain Standardized Patient 

Assessment Data Elements, beginning 

with admissions and discharges (except 

for the hearing, vision, race, and 

ethnicity Standardized Patient 

Assessment Data Elements, which 

would be collected at admission only) 

on October 1, 2022. 

The proposed IRF QRP requirements 

would add no additional burden or cost 

to the active collection under OMB 

control number 0938–0842 (expiration 

12/31/2022). 

b. Impacts for the Long-Term Care 

Hospital Quality Reporting Program for 

FY 2023 

This proposed rule not impose any 

new information collection 

requirements. However, this proposed 

rule does reference associated 

information collections that are not 

discussed in the regulation text 

contained in this document. The 

following is a discussion of this 

information collection discussed later in 

this section, which have already 

received OMB approval. 

In accordance with section 1886(m)(5) 

of the Act, the Secretary must reduce by 

2 percentage points the annual market 

basket payment update otherwise 

applicable to a LTCH for a fiscal year if 

the LTCH does not comply with the 

requirements of the LTCH QRP for that 

fiscal year. As stated in section VIII.B. 

of this proposed rule for purposes of 

calculating the FY 2023 Annual 

Payment Update (APU), we propose that 

LTCHs would begin using the LTCH 

Continuity Assessment Record and 

Evaluation (CARE) Data Set (LCDS) V5.0 

to collect data on the TOH Information 

to Provider-PAC and the TOH 

Information to Patient-PAC measures 

beginning with admissions and 

discharges on October 1, 2022. We also 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36000 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

proposed that LTCHs would begin to 

use the LTCH LCDS V5.0 to collect data 

on certain Standardized Patient 

Assessment Data Elements, beginning 

with admissions and discharges (except 

for the hearing, vision, race, and 

ethnicity Standardized Patient 

Assessment Data Elements, which 

would be collected at admission only) 

on October 1, 2022. 

The proposed LTCH QRP 

requirements would add no additional 

burden or cost to the active collection 

under OMB control number 0938–1163 

(expiration 12/31/2022). 

D. Limitations of Our Analysis 

Our estimates of the effects of this 

proposed rule are subject to significant 

uncertainty. It is difficult to estimate the 

burden and savings from the proposed 

changes because they depend on several 

factors previously described. We 

appreciate that our assumptions are 

simplified and that actual results could 

be considerably higher or lower. 

Although there is uncertainty 

concerning the magnitude of all of our 

estimates, we do not have the data to 

provide specific estimates for each 

proposal, as to the range of possibilities, 

or to estimate all categories of possible 

benefits. We seek comments on all 

aspects of this analysis. 

E. Regulatory Review Cost Estimation 

If regulations impose administrative 

costs on private entities, such as the 

time needed to read and interpret this 

proposed 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 

$114.24 per hour, including overhead 

and fringe benefits https://www.bls.gov/ 

oes/current/oes_nat.htm. This proposed 

rule consists of approximately 121,000 

words. Assuming an average reading 

speed of 250 words per minute, we 

estimate that it would take 

approximately 4.03 hours for the staff to 

review half of this rule. For each entity 

that reviews the rule (we estimate that 

there are 165 reviewers), the estimated 

cost is $574 (4.03 hours × $114.24). 

Therefore, we estimate that the total cost 

of reviewing this proposed rule is 

$75,964.35 ($460.39 × 165 reviewers). 

F. Alternatives Considered 

1. Alternatives Considered to the HH 

PPS Policy Proposals 

For the CY 2022 HH PPS proposed 

rule, we considered alternatives to the 

proposals articulated in section II. of 

this proposed rule. We considered using 

CY 2019 data for ratesetting. However, 

our analysis showed there were only 

small differences in the payment rates 

and impacts in the aggregate when using 

CY 2019 data compared to CY 2020 

data. These differences in payment rates 

reflect small differences in the wage 

index budget neutrality factors 

calculated using CY 2020 data 

compared to using CY 2019 claims data. 

We note, we would not have 

recalibrated the case-mix weights using 

CY 2019 data because CY 2019 data 

would use simulated 30-day periods 

from 60-episodes as CY 2020 is the first 

year of actual PDGM data. Therefore, no 

case-mix weight budget neutrality factor 

using CY 2019 utilization data would be 

applied. We believe it is best to 

continue with our established policy of 

using the most recent, complete data at 

the time of rulemaking for CY 2022 

ratesetting, which would be CY 2020 

claims data. Additionally, we 

considered alternatives to our case-mix 

recalibration proposal. These 

alternatives included an option do a full 

recalibration of the case-mix weights, 

including the functional impairment 

levels, comorbidity subgroups as 

proposed, but also updating the LUPA 

thresholds, as well as an option to not 

recalibrate the case-mix weights, 

functional impairment levels, 

comorbidity subgroups and LUPA 

thresholds. However, we believe that 

recalibrating the PDGM case-mix 

weights, functional levels, and 

comorbidity adjustment subgroups 

while maintaining the LUPA thresholds 

for CY 2022 would more accurately 

adjust home health payments because 

the data would reflect 30-day periods 

under the new PDGM system based on 

actual data rather than data that 

simulated 30-day episodes under the 

old system. The recalibrated case-mix 

weights would also more accurately 

reflect the types of patients currently 

receiving home health services while 

mitigating instability by maintaining the 

LUPA thresholds. As stated previously 

the LUPA thresholds are based on the 

number of overall visits in a particular 

case-mix group (the threshold is the 

10th percentile of visits or 2 visits, 

whichever is greater) instead of a 

relative value (as is used to generate the 

case-mix weight) that would control for 

the impacts of the PHE. We note that 

visit patterns and some of the decrease 

in overall visits in CY 2020 may not be 

representative of visit patterns in CY 

2022. Also, our analysis shows that 

there is more variation in the case-mix 

weights with the full recalibration 

(including updates to the LUPA 

thresholds) than the recalibration with 

the case-mix weights maintained. 

Maintaining the LUPA thresholds 

creates more stability in the weights. 

The recalibrated case-mix weights using 

the current LUPA thresholds are more 

similar to the CY 2020 weights than the 

recalibrated case-mix weights with the 

updated LUPA thresholds. For these 

reasons, we believe it is best to maintain 

the LUPA thresholds for CY 2022 

instead of the alternative full 

recalibration including updates to the 

LUPA thresholds. 

2. Alternatives Considered to the 

HHVBP Policy Proposals 

We considered alternatives to the 

proposed policies in sections III.A. and 

III.B. of this proposed rule. Specifically, 

we considered not expanding the 

HHVBP Model at this point in time, and 

waiting until we have final evaluation 

results from the original HHVBP Model 

before pursuing a national expansion. 

However, we considered that we have 

evaluation results from multiple years of 

the original HHVBP Model, showing 

significant reductions in spending and 

improvements in quality. We believe 

this evidence is sufficient for a national 

expansion of the Model, and note that 

we will continue to review evaluation 

results as they come in for the later 

years of the original HHVBP Model. 

For the expanded HHVBP Model, we 

also considered utilizing the same stateand volume-based cohorts as the 

original HHVBP Model in lieu of the 

national volume-based cohorts we are 

proposing. However, this approach 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36001 

could require grouping together of 

certain States, territories, and the 

District of Columbia that have an 

insufficient number of HHAs at the end 

of the performance year, based solely on 

their lower HHA counts. This would 

also preclude providing benchmarks 

and achievement thresholds 

prospectively. An analysis of the Statelevel impacts of using the revised 

cohorts, including our proposed option, 

nationwide with volume-based cohorts, 

and our alternative, State-level without 

volume-based cohorts, demonstrates 

minimal impacts at the State-level. 

Using CY 2019 data to simulate the 

payment adjustments, the mean 

payment adjustments at the State-level 

are within +/¥ 1.0 percent for both 

cohort options. Relative to the Stateand volume-based cohorts, the national 

volume-based cohorts resulted in the 

largest increases in overall payment 

amounts to Alabama (+1.8 percent), 

Mississippi (+1.8 percent), and TN (+1.4 

percent). The largest decreases in 

overall payment amounts are from 

Minnesota (¥1.7 percent), Connecticut 

(¥1.6 percent), and the Marianas 

Islands (¥1.6 percent). We do not see 

any obvious correlation of the impacts 

within States that are currently in the 

original Model versus those that will be 

new to the expanded Model. 

For the reasons described in section 

III.B.2. of this proposed rule, we are 

proposing to not apply any payment 

adjustments for CY 2022 of the original 

HHVBP Model based on data reported 

in CY 2020 and to instead end the 

original Model early, with the CY 2021 

payment adjustment year. As previously 

noted, we will continue to examine data 

for CY 2020 as it becomes available in 

order to determine whether it would be 

appropriate to utilize such data for CY 

2022 payment adjustments, in 

accordance with current Model policies. 

3. Alternatives Considered Concerning 

Deactivation Payment Prohibition 

As discussed in section VI.B. of this 

proposed rule, we are proposing in new 

§ 424.540(e) that a provider or supplier 

may not receive payment for services or 

items furnished while deactivated under 

§ 424.540(a). Current subregulatory 

guidance permits the provider or 

supplier to bill for services or items 

furnished up to 30 days prior to the 

effective date of the reactivation of the 

provider’s or supplier’s billing 

privileges. We considered the 

alternative of retaining this 30-day 

retroactive period. After careful 

consideration, however, we concluded 

that prohibiting such retroactive 

payments would be the best approach 

from a program integrity perspective. As 

we stated in section VI.B. of this 

proposed rule, we do not believe a 

provider or supplier should be 

effectively rewarded for its nonadherence to enrollment requirements 

by receiving retroactive payment for 

services or items furnished while out of 

compliance. Moreover, the prospect of a 

payment prohibition could well spur 

providers and suppliers to avoid such 

non-compliance. 

G. Accounting Statement and Tables 

1. HH PPS 

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 43, we have prepared 

an accounting statement showing the 

classification of the transfers and 

benefits associated with the CY 2022 

HH PPS provisions of this rule. 

2. HHVBP Model Expansion 

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 44, we have prepared 

an accounting statement showing the 

classification of the expenditures 

associated with this proposed rule as 

they relate to hospitals and SNFs. Table 

44 provides our best estimate of the 

decrease in Medicare payments under 

the proposed expanded HHVBP Model. 

3. HHQRP 

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 45, we have prepared 

an accounting statement showing the 

classification of the expenditures 

associated with this proposed rule as 

they relate to HHAs. Table 45 provides 

our best estimate of the decrease in 

Medicare payments. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.065</GPH> EP07JY21.066</GPH>

TABLE 43: ACCOUNTING STATEMENT: HH PPS CLASSIFICATION OF 

ESTIMATED TRANSFERS AND BENEFITS, FROM CY 2021 TO 2022 

Cate2ory Transfers 

Annualized Monetized Transfers $310 million 

From Whom to Whom? Federal Government to HHAs 

TABLE 44: ACCOUNTING STATEMENT: EXPANDED HHVBP MODEL 

CLASSIFICATION OF ESTIMATED TRANSFERS AND COSTS FOR CYs 2022 - 2026 

Catee;ory Transfers Discount Rate Period Covered 

Ammalized Monetized Transfers -$769.2 Million 7% CYs 2022-2026 

Ammalized Monetized Transfers -$688.7 Million 3% CYs 2022-2026 

From Whom to Whom? Federal Government to Hosoitals and SNFs 
36002 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

143https://www.sba.gov/sites/default/files/2019- 

08/SBA%20Table%20of%20Size%20Standards_

Effective%20Aug%2019%2C%202019_Rev.pdf. 

H. Regulatory Flexibility Act (RFA) 

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. In addition, 

HHAs and home infusion therapy 

suppliers are small entities, as that is 

the term used in the RFA. Individuals 

and States are not included in the 

definition of a small entity. 

The North American Industry 

Classification System (NAICS) was 

adopted in 1997 and is the current 

standard used by the Federal statistical 

agencies related to the U.S. business 

economy. We utilized the NAICS U.S. 

industry title ‘‘Home Health Care 

Services’’ and corresponding NAICS 

code 621610 in determining impacts for 

small entities. The NAICS code 621610 

has a size standard of $16.5 million 143

and approximately 96 percent of HHAs 

and home infusion therapy suppliers are 

considered small entities. Table 46 

shows the number of firms, revenue, 

and estimated impact per home health 

care service category. 

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. We note also, 

and as discussed in section XI.C.6. of 

this proposed rule, our proposal to 

prohibit payments for services and 

items furnished by deactivated 

providers and suppliers would affect 

only a very limited number of Medicare 

providers and suppliers. Therefore, the 

Secretary has determined that this HH 

PPS proposed rule would not have 

significant economic impact on a 

substantial number of small entities. 

Guidance issued by the Department of 

Health and Human Services interpreting 

the Regulatory Flexibility Act considers 

the 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. Among the over 7,500 HHAs that 

are estimated to qualify to compete in 

the expanded HHVBP Model, we 

estimate that the percent payment 

adjustment resulting from this rule 

would be larger than 3 percent, in 

magnitude, for about 28 percent of 

competing HHAs (estimated by applying 

the proposed 5-percent maximum 

payment adjustment under the 

expanded Model to CY 2019 data). As 

a result, more than the RFA threshold of 

5-percent of HHA providers nationally 

would be significantly impacted. We 

refer readers to Tables G6 and G7 of this 

proposed rule for our analysis of 


khammond on DSKJM1Z7X2PROD with PROPOSALS2EP07JY21.067</GPH> EP07JY21.068</GPH>

TABLE 45: ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED 

COSTS OF OASIS ITEM COLLECTION, FROM CY 2021 TO CY 2022 

Costs 

Annualized Net Decreased Mone $-2,762,277 

TABLE 46: NUMBER OF FIRMS, REVENUE, AND ESTIMATED IMPACT OF HOME 

HEALTH CARE SERVICES BY NAICS CODE 621610 

NAICS NAICS Description Enterprise Size Number Receipts Estimated Impact 

Code of Firms ($1,000) ($1,000) per 

Enterprise Size 

621610 Home Health Care Services <100 5,861 210,697 $35.95 

621610 Home Health Care Services 100-499 5,687 1,504,668 $264.58 

621610 Home Health Care Services 500-999 3,342 2,430,807 $727.35 

621610 Home Health Care Services 1,000-2,499 4,434 7,040,174 $1,587.77 

621610 Home Health Care Services 2,500-4,999 1,951 6,657,387 $3,412.29 

621610 Home Health Care Services 5,000-7,499 672 3,912,082 $5,821.55 

621610 Home Health Care Services 7,500-9,999 356 2,910,943 $8,176.81 

621610 Home Health Care Services 10,000-14,999 346 3,767,710 $10,889.34 

621610 Home Health Care Services 15,000-19,999 191 2,750,180 $14,398.85 

621610 Home Health Care Services >20,000 961 51,776,636 $53,877.87 

621610 Home Health Care Services Total 23,801 82,961,284 $3,485.62 

Source: Data obtained from United States Census Bureau table "us_ 6digitnaics _rcptsize _ 2017" (SOURCE: 2017 

County Business Patterns and Economic Census) Release Date: 5/28/2021: https:/ /www2.census.gov/programssurveys/susb/tables/2017 / 

Notes: Estimated impact is calculated as Receipts ($1,000)/Enterprise Size. 
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36003 

payment adjustment distributions by 

State, HHA characteristics, HHA size 

and percentiles. 

Thus, the Secretary has determined 

that this proposed rule would have a 

significant economic impact on a 

substantial number of small entities. 

Though the RFA requires consideration 

of alternatives to avoid economic 

impacts on small entities, the intent of 

the rule, itself, is to encourage quality 

improvement by HHAs through the use 

of economic incentives. As a result, 

alternatives to mitigate the payment 

reductions would be contrary to the 

intent of the rule, which is to test the 

effect on quality and costs of care of 

applying payment adjustments based on 

HHAs’ performance on quality 

measures. 

I. Unfunded Mandates Reform Act 

(UMRA) 

Section 202 of UMRA 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 2021, that 

threshold is approximately $158 

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 $158 million or more. 

J. Federalism 

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. 

K. Conclusion 

In conclusion, we estimate that the 

provisions in this proposed rule would 

result in an estimated net increase in 

home health payments of 1.7 percent for 

CY 2022 ($310 million). The $310 

million increase in estimated payments 

for CY 2022 reflects the effects of the CY 

2022 home health payment update 

percentage of 1.8 percent ($330 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 

2022 ($20 million decrease). 

L. Executive Order 12866 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget reviewed this 

proposed rule. 

I, Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on June 16, 

2021. 

List of Subjects 

42 CFR Part 409 

Health facilities, Medicare. 

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. 

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Health 

professions, Medicare, Reporting and 

recordkeeping requirements. 

42 CFR Part 489 

Health facilities, Medicare Reporting 

and recordkeeping requirements. 

42 CFR Part 498 

Administrative practice and 

procedure, Health facilities, Health 

professions, Medicare, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV as follows: 

PART 409—HOSPITAL INSURANCE 

BENEFITS 

■ 1. The authority citation for part 409 

continues to read as follows: 

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

■ 2. Section 409.43 is amended— 

■ a. By revising the paragraph (b) 

subject heading; 

■ b. In paragraph (c)(1)(i)(C) by 

removing the phrase ‘‘physician’s 

orders’’ and adding in its place the 

phrase ‘‘physician’s or allowed 

practitioner’s orders’’; 

■ c. In paragraphs (c)(1)(i)(D), (c)(2)(i), 

and (c)(3) by removing the term 

‘‘physician’’ and adding in its place the 

phrase ‘‘physician or allowed 

practitioner’’; and 

■ d. In paragraph (d) by removing the 

phrase ’’ based on a physician’s oral 

orders’’ and adding in its place the 

phrase ‘‘based on a physician’s or 

allowed practitioner’s oral orders’’. 

The revision reads as follows: 

§ 409.43 Plan of care requirements. 

* * * * * 

(b) Physician’s or allowed 

practitioner’s orders. * * * 

* * * * * 

PART 424—CONDITIONS FOR 

MEDICARE PAYMENT 

■ 3. The authority for part 424 

continues to read as follows: 

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

■ 4. Section 424.520 is amended by 

revising paragraph (d) to read as 

follows: 

§ 424.520 Effective date of billing 

privileges. 

* * * * * 

(d) Additional provider and supplier 

types. (1) The effective date of billing 

privileges for the provider and supplier 

types identified in paragraph (d)(2) of 

this section is the later of— 

(i) The date of filing of a Medicare 

enrollment application that was 

subsequently approved by a Medicare 

contractor; or 

(ii) The date that the provider or 

supplier first began furnishing services 

at a new practice location. 

(2) The provider and supplier types to 

which paragraph (d)(1) of this section 

applies are as follows: 

(i) Physicians. 

(ii) Non-physician practitioners. 

(iii) Physician organizations. 

(iv) Non-physician practitioner 

organizations. 

(v) Ambulance suppliers. 

(vi) Opioid treatment programs. 

(vii) Part B hospital departments. 

(viii) Clinical Laboratory 

Improvement Amendment labs. 

(ix) Intensive cardiac rehabilitation 

facilities. 

(x) Mammography centers. 

(xi) Mass immunizers/pharmacies. 

(xii) Radiation therapy centers. 

(xiii) Home infusion therapy 

suppliers. 

(xiv) Physical therapists. 

(xv) Occupational therapists. 

(xvi) Speech language pathologists. 

■ 5. Section 424.521 is amended by 

revising the section heading and 

paragraph (a) to read as follows: 

§ 424.521 Request for payment by certain 

provider and supplier types. 

(a) Request for payment by certain 

provider and supplier types. (1) The 

providers and suppliers identified in 

paragraph (a)(2) of this section may 

retrospectively bill for services when 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36004 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

the provider or supplier has met all 

program requirements (including State 

licensure requirements), and services 

were provided at the enrolled practice 

location for up to— 

(i) Thirty days prior to their effective 

date if circumstances precluded 

enrollment in advance of providing 

services to Medicare beneficiaries; or 

(ii) 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. 5121–5206 (Stafford Act) 

precluded enrollment in advance of 

providing services to Medicare 

beneficiaries. 

(2) The provider and supplier types to 

which paragraph (a) applies are as 

follows: 

(i) Physicians. 

(ii) Non-physician practitioners. 

(iii) Physician organizations. 

(iv) Non-physician practitioner 

organizations. 

(v) Ambulance suppliers. 

(vi) Opioid treatment programs. 

(vii) Part B hospital departments. 

(viii) Clinical Laboratory 

Improvement Amendment labs. 

(ix) Intensive cardiac rehabilitation 

facilities. 

(x) Mammography centers. 

(xi) Mass immunizers/pharmacies. 

(xii) Radiation therapy centers. 

(xiii) Home infusion therapy 

suppliers. 

(xiv) Physical therapists. 

(xv) Occupational therapists. 

(xvi) Speech language pathologists. 

* * * * * 

■ 6. Section 424.522 is added to read as 

follows: 

§ 424.522 Additional effective dates. 

(a) Reassignments. A reassignment of 

benefits under § 424.80 is effective 

beginning 30 days before the Form 

CMS–855R is submitted if all applicable 

requirements during that period were 

otherwise met. 

(b) Form CMS–855O enrollment. The 

effective date of a Form CMS–855O 

enrollment is the date on which the 

Medicare contractor received the Form 

CMS–855O application if all other 

requirements are met. 

■ 7. Section 424.525 is amended— 

■ a. By revising paragraph (a)(1); 

■ b. In paragraphs (a)(2), (a)(3), and (b) 

by removing the phrase ‘‘prospective 

provider’’ and adding the word 

‘‘provider’’ each time it appears; and 

■ c. By adding paragraph (e). 

The revision and addition read as 

follows: 

§ 424.525 Rejection of a provider’s or 

supplier’s application for Medicare 

enrollment. 

(a) * * * 

(1) The provider or supplier fails to 

furnish complete information on the 

provider/supplier enrollment 

application within 30 calendar days 

from the date of the Medicare 

contractor’s request for the missing 

information. This includes the following 

situations: 

(i) The application is missing data 

required by CMS or the Medicare 

contractor to process the application 

(such as, but not limited to, names, 

Social Security Number, contact 

information, and practice location 

information). 

(ii) The application is unsigned or 

undated. 

(iii) The application contains a copied 

or stamped signature. 

(iv) The application is signed more 

than 120 days prior to the date on which 

the Medicare contractor received the 

application. 

(v) The application is signed by a 

person unauthorized to do so under this 

subpart. 

(vi) For paper applications, the 

required certification statement is 

missing. 

(vii) The paper application is 

completed in pencil. 

(viii) The application is submitted via 

fax or email when the provider or 

supplier was not otherwise permitted to 

do so. 

(ix) The provider or supplier failed to 

submit all of the forms needed to 

process a Form CMS–855 reassignment 

package within 30 days of receipt. 

(x) The provider or supplier 

submitted the incorrect Form CMS–855 

application. 

* * * * * 

(e) Applicability. Except as otherwise 

specified in the applicable reason for 

rejection under paragraph (a) of this 

section, this section applies to all CMS 

Medicare provider enrollment 

application submissions, including, but 

not limited to, the following: 

(1) Form CMS–855 initial 

applications, change of information 

requests, changes of ownership, 

revalidations, and reactivations. 

(2) Form CMS–588 (Electronic Funds 

Transfer (EFT) Authorization 

Agreement) submissions. 

(3) Form CMS–20134 (Medicare 

Enrollment Application; Medicare 

Diabetes Prevention Program (MDPP) 

Suppliers) submissions. 

(4) Any electronic or successor 

versions of the forms identified in 

paragraphs (e)(1) through (3) of this 

section. 

■ 8. Section 424.526 is added to read as 

follows: 

§ 424.526 Return of a provider’s or 

supplier’s enrollment application. 

(a) Reasons for return. CMS may 

return a provider’s or supplier’s 

enrollment application for any of the 

following reasons: 

(1) The provider or supplier sent its 

paper Form CMS–855, Form CMS–588, 

or Form CMS–20134 application to the 

incorrect Medicare contractor for 

processing. 

(2) The Medicare contractor received 

the application more than 60 days prior 

to the effective date listed on the 

application. (This does not apply to 

providers and suppliers submitting a 

Form CMS–855A application, 

ambulatory surgical centers, or portable 

x-ray suppliers.) 

(3) The seller or buyer in a change of 

ownership submitted its Form CMS– 

855A or Form CMS–855B application 

more than 90 days prior to the 

anticipated date of the sale. 

(4) The Medicare contractor received 

an initial application more than 180 

days prior to the effective date listed on 

the application from a provider or 

supplier submitting a Form CMS–855A 

application, an ambulatory surgical 

center, or a portable x-ray supplier. 

(5) The Medicare contractor confirms 

that the provider or supplier submitted 

an initial enrollment application prior 

to the expiration of the time period in 

which it is entitled to appeal the denial 

of its previously submitted application. 

(6) The provider or supplier 

submitted an initial enrollment 

application prior to the expiration of 

their existing re-enrollment bar under 

§ 424.535 or reapplication bar under 

§ 424.530(f). 

(7) The application is not needed for 

(or is inapplicable to) the transaction in 

question. 

(8) The provider or supplier 

submitted a revalidation application 

more than 7 months prior to the 

provider’s or supplier’s revalidation due 

date. 

(9) A Medicare Diabetes Prevention 

Program supplier submitted an 

application with a coach start date more 

than 30 days in the future. 

(10) The provider or supplier requests 

that their application be withdrawn 

prior to or during the Medicare 

contractor’s processing thereof. 

(11) The provider or supplier submits 

an application that is an exact duplicate 

of an application that has already been 

processed or is currently being 

processed or is pending processing. 

(12) The provider or supplier submits 

a paper Form CMS–855 or Form CMS– 

20134 enrollment application that is 

outdated or has been superseded by a 

revised version. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36005 

(13) The provider or supplier submits 

a Form CMS–855A or Form CMS–855B 

initial application followed by a Form 

CMS–855A or Form CMS–855B change 

of ownership application. If the 

Medicare contractor— 

(i) Has not yet made a 

recommendation for approval 

concerning the initial application, both 

applications may be returned. 

(ii) Has made a recommendation for 

approval concerning the initial 

application, the Medicare contractor 

may return the change of ownership 

application. If, per the Medicare 

contractor’s written request, the 

provider or supplier fails to submit a 

new initial Form CMS–855A or Form 

CMS–855B application containing the 

new owner’s information within 30 days 

of the date of the letter, the Medicare 

contractor may return the originally 

submitted initial Form CMS–855A or 

Form CMS–855B application. 

(b) Appeals. A provider or supplier is 

not afforded appeal rights if their 

application is returned under this 

section. 

(c) Applicability. Except as otherwise 

specified in the applicable return reason 

under paragraph (a) of this section, this 

section applies to all CMS Medicare 

provider enrollment application 

submissions including, but not limited 

to, the following: 

(1) Form CMS–855 initial 

applications, change of information 

requests, changes of ownership, 

revalidations, and reactivations. 

(2) Form CMS–588 submissions. 

(3) Form CMS–20134 submissions. 

(4) Any electronic or successor 

versions of the forms identified in 

paragraphs (c)(1) through (3) of this 

section. 

■ 9. Section 424.540 is amended— 

■ a. By revising paragraph (a)(2); 

■ b. By adding paragraphs (a)(4) through 

(8); 

■ c. By revising paragraphs (b)(1) and 

(c); and 

■ d. By adding paragraphs (d) and (e). 

The revisions and additions read as 

follows: 

§ 424.540 Deactivation of Medicare billing 

privileges. 

(a) * * * 

(2) The provider or supplier does not 

report a change to the information 

supplied on the enrollment application 

within the applicable time period 

required under this title. 

* * * * * 

(4) The provider or supplier is not in 

compliance with all enrollment 

requirements in this title. 

(5) The provider’s or supplier’s 

practice location is non-operational or 

otherwise invalid. 

(6) The provider or supplier is 

deceased. 

(7) The provider or supplier is 

voluntarily withdrawing from Medicare. 

(8) The provider is the seller in an 

HHA change of ownership under 

§ 424.550(b)(1). 

(b) * * * 

(1) In order for a deactivated provider 

or supplier to reactivate its Medicare 

billing privileges, the provider or 

supplier must recertify that its 

enrollment information currently on file 

with Medicare is correct, furnish any 

missing information as appropriate, and 

be in compliance with all applicable 

enrollment requirements in this title. 

* * * * * 

(c) Effect of deactivation. The 

deactivation of Medicare billing 

privileges does not have any effect on a 

provider’s or supplier’s participation 

agreement or any conditions of 

participation. 

(d) Effective dates. (1)(i) Except as 

provided in paragraph (d)(1)(ii) of this 

section, the effective date of a 

deactivation is the date on which the 

deactivation is imposed under this 

section. 

(ii) A retroactive deactivation effective 

date (based on the date that the 

provider’s or supplier’s action or noncompliance occurred or commenced (as 

applicable)) may be imposed in the 

following instances: 

(A) For the deactivation reasons in 

paragraphs (a)(2) through (4) of this 

section, the effective date is the date on 

which the provider or supplier became 

non-compliant. 

(B) For the deactivation reason in 

paragraph (a)(5) of this section, the 

effective date is the date on which the 

provider’s or supplier’s practice location 

became non-operational or otherwise 

invalid. 

(C) For the deactivation reason in 

paragraph (a)(6) of this section, the 

effective date is the date of death of the 

provider or supplier. 

(D) For the deactivation reason in 

paragraph (a)(7) of this section, the 

effective date is the date on which the 

provider or supplier voluntarily 

withdrew from Medicare. 

(E) For the deactivation reason in 

paragraph (a)(8) of this section, the 

effective date is the date of the sale. 

(2) The effective date of a reactivation 

of billing privileges under this section is 

the date on which the Medicare 

contractor received the provider’s or 

supplier’s reactivation submission that 

was processed to approval by the 

Medicare contractor. 

(e) Payment prohibition. A provider or 

supplier may not receive payment for 

services or items furnished while 

deactivated under this section. 

■ 10. Section 424.550 is amended by 

revising paragraph (b)(2)(i) to read as 

follows: 

§ 424.550 Prohibitions on the sale or 

transfer of billing privileges. 

* * * * * 

(b) * * * 

(2)(i) The HHA submitted two 

consecutive years of full cost reports 

since initial enrollment or the last 

change in majority ownership, 

whichever is later. For purposes of this 

exception, low utilization or no 

utilization cost reports do not qualify as 

full cost reports. 

* * * * * 

PART 484—HOME HEALTH SERVICES 

■ 11. The authority citation for part 484 

continues to read as follows: 

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

■ 12. Section 484.55 is amended by 

revising paragraphs (a)(2) and (b)(3) to 

read as follows: 

§ 484.55 Condition of participation: 

Comprehensive assessment of patients. 

* * * * * 

(a) * * * 

(2) When rehabilitation therapy 

service (speech language pathology, 

physical therapy, or occupational 

therapy) is the only service ordered by 

the physician or allowed practitioner 

who is responsible for the home health 

plan of care, the initial assessment visit 

may be made by the appropriate 

rehabilitation skilled professional. For 

Medicare patients, an occupational 

therapist may complete the initial 

assessment when occupational therapy 

is ordered with another qualifying 

rehabilitation therapy service (speechlanguage pathology or physical therapy) 

that establishes program eligibility. 

(b) * * * 

(3) When physical therapy, speechlanguage pathology, or occupational 

therapy is the only service ordered by 

the physician or allowed practitioner, a 

physical therapist, speech-language 

pathologist, or occupational therapist 

may complete the comprehensive 

assessment, and for Medicare patients, 

determine eligibility for the Medicare 

home health benefit, including 

homebound status. For Medicare 

patients, the occupational therapist may 

complete the comprehensive assessment 

when occupational therapy is ordered 

with another qualifying rehabilitation 

therapy service (speech-language 

pathology or physical therapy) that 

establishes program eligibility. 

* * * * * 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36006 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

■ 13. Section 484.80 is amended by 

■ a. Revising paragraph (h)(1)(i); 

■ b. Redesignating paragraphs (h)(1)(ii) 

and (iii) as (h)(1)(iii) and (iv), 

respectively; 

■ c. Adding a new paragraph (h)(1)(ii); 

and 

■ d. Revising paragraphs (h)(2) and (3). 

The revisions and addition read as 

follows: 

§ 484.80 Condition of participation: Home 

health aide services. 

* * * * * 

(h) * * * 

(1)(i) If home health aide services are 

provided to a patient who is receiving 

skilled nursing, physical or 

occupational therapy, or speech 

language pathology services— 

(A) A registered nurse or other 

appropriate skilled professional who is 

familiar with the patient, the patient’s 

plan of care, and the written patient care 

instructions described in paragraph (g) 

of this section, must complete a 

supervisory assessment of the aide 

services being provided no less 

frequently than every 14 days; and 

(B) The home health aide does not 

need to be present during the 

supervisory assessment described in 

paragraph (h)(1)(i)(A) of this section. 

(ii) The supervisory assessment must 

be completed onsite (that is, an in 

person visit), or by using two-way 

audio-video telecommunications 

technology that allows for real-time 

interaction between the registered nurse 

(or other appropriate skilled 

professional) and the patient, not to 

exceed 2 virtual supervisory 

assessments per HHA in a 60-day 

period. 

* * * * * 

(2)(i) If home health aide services are 

provided to a patient who is not 

receiving skilled nursing care, physical 

or occupational therapy, or speech 

language pathology services— 

(A) The registered nurse must make 

an onsite, in person visit every 60 days 

to assess the quality of care and services 

provided by the home health aide and 

to ensure that services meet the patient’s 

needs; and 

(B) The home health aide does not 

need to be present during this visit. 

(ii) Semi-annually the registered nurse 

must make an on-site visit to the 

location where a patient is receiving 

care in order to observe and assess each 

home health aide while he or she is 

performing non-skilled care. 

(3) If a deficiency in aide services is 

verified by the registered nurse or other 

appropriate skilled professional during 

an on-site visit, then the agency must 

conduct, and the home health aide must 

complete, retraining and a competency 

evaluation for the deficient and all 

related skills. 

* * * * * 

Subpart F—Home Health Value-Based 

Purchasing (HHVBP) Models 

■ 14. The heading for subpart F is 

revised to read as set forth above. 

■ 15. Subpart F is amended by adding 

an undesignated center heading before 

§ 484.300 to read as follows: 

HHVBP Model Components for 

Competing Home Health Agencies 

Within State Boundaries for the 

Original HHVBP Model 

■ 16. Section 484.305 is amended by 

revising the definition of ‘‘Applicable 

percent’’ to read as follows: 

§ 484.305 Definitions. 

* * * * * 

Applicable percent means a 

maximum upward or downward 

adjustment for a given performance 

year, not to exceed the following: 

(1) For CY 2018, 3-percent. 

(2) For CY 2019, 5-percent. 

(3) For CY 2020, 6-percent. 

(4) For CY 2021, 7-percent. 

* * * * * 

§ 484.315 [Amended] 

■ 17. Section 484.315 is amended by 

removing paragraph (d). 

■ 18. Subpart F is amended by adding 

an undesignated center heading and 

§§ 484.340 through 484.375 to read as 

follows: 

* * * * * 

HHVBP Model Components for 

Competing Home Health Agencies 

(HHAs) for HHVBP Model Expansion— 

Effective January 1, 2022 

Sec. 

484.340 Basis and scope of subpart. 

484.345 Definitions. 

484.350 Applicability of the Expanded 

Home Health Value-Based Purchasing 

(HHVBP) Model. 

484.355 Data reporting for measures and 

evaluation and the public reporting of 

model data under the expanded Home 

Health Value-Based Purchasing (HHVBP) 

Model. 

484.360 Calculation of the Total 

Performance Score. 

484.365 Payments for home health services 

under the Expanded Home Health ValueBased Purchasing (HHVBP) Model. 

484.370 Process for determining and 

applying the value-based payment 

adjustment under the Expanded Home 

Health Value-Based Purchasing (HHVBP) 

Model. 

484.375 Appeals process for the Expanded 

Home Health Value-Based Purchasing 

(HHVBP) Model. 

HHVBP Model Components for 

Competing Home Health Agencies 

(HHAs) for HHVBP Model Expansion— 

Effective January 1, 2022 

§ 484.340 Basis and scope of subpart. 

This subpart is established under 

sections 1102, 1115A, and 1871 of the 

Act (42 U.S.C. 1315a), which authorizes 

the Secretary to issue regulations to 

operate the Medicare program and test 

innovative payment and service 

delivery models to reduce program 

expenditures while preserving or 

enhancing the quality of care furnished 

to individuals under Titles XVIII and 

XIX. 

§ 484.345 Definitions. 

As used in this subpart— 

Achievement threshold means the 

median (50th percentile) of home health 

agency performance on a measure 

during a baseline year, calculated 

separately for the larger- and smallervolume cohorts. 

Applicable measure means a measure 

(OASIS- and claims-based measures) or 

a measure component (HHCAHPS 

survey measure) for which a competing 

HHA has provided a minimum of one of 

the following: 

(1) Twenty home health episodes of 

care per year for each of the OASISbased measures. 

(2) Twenty home health episodes of 

care per year for each of the claimsbased measures. 

(3) Forty completed surveys for each 

component included in the HHCAHPS 

Survey measure. 

Applicable percent means a 

maximum upward or downward 

adjustment for a given payment year 

based on the applicable performance 

year, not to exceed 5 percent. 

Baseline year means the year against 

which measure performance in a 

performance year will be compared. 

Benchmark refers to the mean of the 

top decile of Medicare-certified HHA 

performance on the specified quality 

measure during the baseline year, 

calculated separately for the larger- and 

smaller-volume cohorts. 

Competing home health agency or 

agencies (HHA or HHAs) means an 

agency or agencies that meet the 

following: 

(1) Has or have a current Medicare 

certification; and 

(2) Is or are being paid by CMS for 

home health care services. 

Home health prospective payment 

system (HH PPS) refers to the basis of 

payment for HHAs as set forth in 

§§ 484.200 through 484.245. 

Improvement threshold means an 

individual competing HHA’s 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36007 

performance level on a measure during 

the baseline year. 

Larger-volume cohort means the 

group of competing HHAs that are 

participating in the HHCAHPS survey in 

accordance with § 484.245. 

Linear exchange function is the means 

to translate a competing HHA’s Total 

Performance Score into a value-based 

payment adjustment percentage. 

Nationwide means the 50 States and 

the US territories, including the District 

of Columbia. 

Payment adjustment means the 

amount by which a competing HHA’s 

final claim payment amount under the 

HH PPS is changed in accordance with 

the methodology described in § 484.370. 

Payment year means the calendar year 

in which the applicable percent, a 

maximum upward or downward 

adjustment, applies. 

Performance year means the calendar 

year during which data are collected for 

the purpose of calculating a competing 

HHA’s performance on measures. 

Smaller-volume cohort means the 

group of competing HHAs that are 

exempt from participation in the 

HHCAHPS survey in accordance with 

§ 484.245. 

Total Performance Score (TPS) means 

the numeric score ranging from 0 to 100 

awarded to each competing HHA based 

on its performance under the expanded 

HHVBP Model. 

§ 484.350 Applicability of the Expanded 

Home Health Value-Based Purchasing 

(HHVBP) Model. 

(a) General rule. The expanded 

HHVBP Model applies to all Medicarecertified HHAs nationwide. 

(b) New HHAs. For an HHA that is 

certified by Medicare on or after January 

1, 2019, the baseline year is the first full 

calendar year of services beginning after 

the date of Medicare certification, with 

the exception of HHAs certified on 

January 1, 2019 through December 31, 

2019, for which the baseline year is CY 

2021, and the first performance year is 

the first full calendar year following the 

baseline year. 

§ 484.355 Data reporting for measures and 

evaluation and the public reporting of 

model data under the expanded Home 

Health Value-Based Purchasing (HHVBP) 

Model. 

(a) Competing home health agencies 

will be evaluated using a set of quality 

measures. 

(1) Data submission. Except as 

provided in paragraph (d) of this 

section, and for a performance year, an 

HHA must submit all of the following to 

CMS in the form and manner, and at a 

time, specified by CMS: 

(i) Data on measures specified under 

the expanded HHVBP model. 

(ii) HHCAHPS Survey data. For 

purposes of HHCAHPS Survey data 

submission, the following additional 

requirements apply: 

(A) Survey requirements. An HHA 

must contract with an approved, 

independent HHCAHPS survey vendor 

to administer the HHCAHPS survey on 

its behalf. 

(B) CMS approval. CMS approves an 

HHCAHPS survey vendor if the 

applicant has been in business for a 

minimum of 3 years and has conducted 

surveys of individuals and samples for 

at least 2 years. 

(C) Definition of survey of individuals. 

For the HHCAHPS survey, a ‘‘survey of 

individuals’’ is defined as the collection 

of data from at least 600 individuals 

selected by statistical sampling methods 

and the data collected are used for 

statistical purposes. 

(D) Administration of the HHCAHPS 

survey. No organization, firm, or 

business that owns, operates, or 

provides staffing for an HHA is 

permitted to administer its own 

HHCAHPS Survey or administer the 

survey on behalf of any other HHA in 

the capacity as an HHCAHPS survey 

vendor. Such organizations are not 

approved by CMS as HHCAHPS survey 

vendors. 

(E) Compliance by HHCAHPS survey 

vendors. Approved HHCAHPS survey 

vendors must fully comply with all 

HHCAHPS survey oversight activities, 

including allowing CMS and its 

HHCAHPS survey team to perform site 

visits at the vendors’ company 

locations. 

(F) Patient count exemption. An HHA 

that has less than 60 eligible unique 

HHCAHPS survey patients must 

annually submit to CMS its total 

HHCAHPS survey patient count to be 

exempt from the HHCAHPS survey 

reporting requirements for a calendar 

year. 

(2) [Reserved] 

(b) Competing home health agencies 

are required to collect and report such 

information as the Secretary determines 

is necessary for purposes of monitoring 

and evaluating the expanded HHVBP 

Model under section 1115A(b)(4) of the 

Act (42 U.S.C. 1315a). 

(c) For each performance year of the 

expanded HHVBP Model, CMS publicly 

reports applicable measure benchmarks 

and achievement thresholds for each 

cohort as well as all of the following for 

each competing HHA that qualified for 

a payment adjustment for the applicable 

performance year on a CMS website: 

(1) The Total Performance Score. 

(2) The percentile ranking of the Total 

Performance Score. 

(3) The payment adjustment 

percentage. 

(4) Applicable measure results and 

improvement thresholds. 

(d) CMS may grant an exception with 

respect to quality data reporting 

requirements in the event of 

extraordinary circumstances beyond the 

control of the HHA. CMS may grant an 

exception as follows: 

(1) A competing HHA that wishes to 

request an exception with respect to 

quality data reporting requirements 

must submit its request to CMS within 

90 days of the date that the 

extraordinary circumstances occurred. 

Specific requirements for submission of 

a request for an exception are available 

on the CMS website. 

(2) CMS may grant an exception to 

one or more HHAs that have not 

requested an exception if CMS 

determines either of the following: 

(i) That a systemic problem with CMS 

data collection systems directly affected 

the ability of the HHA to submit data. 

(ii) That an extraordinary 

circumstance has affected an entire 

region or locale. 

§ 484.360 Calculation of the Total 

Performance Score. 

A competing HHA’s Total 

Performance Score for a performance 

year is calculated as follows: 

(a) CMS awards points to the 

competing home health agency for 

performance on each of the applicable 

measures. 

(1) CMS awards greater than or equal 

to 0 points and less than 10 points for 

achievement to each competing home 

health agency whose performance on a 

measure during the applicable 

performance year meets or exceeds the 

applicable cohort’s achievement 

threshold but is less than the applicable 

cohort’s benchmark for that measure. 

(2) CMS awards greater than 0 but less 

than 9 points for improvement to each 

competing home health agency whose 

performance on a measure during the 

applicable performance year exceeds the 

improvement threshold but is less than 

the applicable cohort’s benchmark for 

that measure. 

(3) CMS awards 10 points to a 

competing home health agency whose 

performance on a measure during the 

applicable performance year meets or 

exceeds the applicable cohort’s 

benchmark for that measure. 

(b) For all performance years, CMS 

calculates the weighted sum of points 

awarded for each applicable measure 

within each category of measures 

(OASIS-based, claims-based, and 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36008 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

HHCAHPS Survey-based) weighted at 

35 percent for the OASIS-based measure 

category, 35 percent for the claimsbased measure category, and 30 percent 

for the HHCAHPS Survey measure 

category when all three measure 

categories are reported, to calculate a 

value worth 100 percent of the Total 

Performance Score. 

(1) Where a single measure category is 

not included in the calculation of the 

Total Performance Score for an 

individual HHA, due to insufficient 

volume for all of the measures in the 

category, the remaining measure 

categories are reweighted such that the 

proportional contribution of each 

remaining measure category is 

consistent with the weights assigned 

when all three measure categories are 

available. Where two measure categories 

are not included in the calculation of 

the Total Performance Score for an 

individual HHA, due to insufficient 

volume for all measures in those 

measure categories, the remaining 

measure category is weighted at 100 

percent of the Total Performance Score. 

(2) When one or more, but not all, of 

the measures in a measure category are 

not included in the calculation of the 

Total Performance Score for an 

individual HHA, due to insufficient 

volume for at least one measure in the 

category, the remaining measures in the 

category are reweighted such that the 

proportional contribution of each 

remaining measure is consistent with 

the weights assigned when all measures 

within the category are available. 

(c) The sum of the weight-adjusted 

points awarded to a competing HHA for 

each applicable measure is the 

competing HHA’s Total Performance 

Score for the calendar year. A 

competing HHA must have a minimum 

of five applicable measures to receive a 

Total Performance Score. 

§ 484.365 Payments for home health 

services under the Expanded Home Health 

Value-Based Purchasing (HHVBP) Model. 

CMS determines a payment 

adjustment up to the applicable percent, 

upward or downward, under the 

expanded HHVBP Model for each 

competing HHA based on the agency’s 

Total Performance Score using a linear 

exchange function that includes all 

other HHAs in its cohort that received 

a Total Performance Score for the 

applicable performance year. Payment 

adjustments made under the expanded 

HHVBP Model are calculated as a 

percentage of otherwise-applicable 

payments for home health services 

provided under section 1895 of the Act 

(42 U.S.C. 1395fff). 

§ 484.370 Process for determining and 

applying the value-based payment 

adjustment under the Expanded Home 

Health Value-Based Purchasing (HHVBP) 

Model. 

(a) General. Competing home health 

agencies are ranked within the largervolume and smaller-volume cohorts 

nationwide based on the performance 

standards that apply to the expanded 

HHVBP Model for the baseline year, and 

CMS makes value-based payment 

adjustments to the competing HHAs as 

specified in this section. 

(b) Calculation of the value-based 

payment adjustment amount. The 

value-based payment adjustment 

amount is calculated by multiplying the 

Home Health Prospective Payment final 

claim payment amount as calculated in 

accordance with § 484.205 by the 

payment adjustment percentage. 

(c) Calculation of the payment 

adjustment percentage. The payment 

adjustment percentage is calculated as 

the product of all of the following: 

(1) The applicable percent as defined 

in § 484.345. 

(2) The competing HHA’s Total 

Performance Score divided by 100. 

(3) The linear exchange function 

slope. 

§ 484.375 Appeals process for the 

Expanded Home Health Value-Based 

Purchasing (HHVBP) Model. 

(a) Requests for recalculation—(1) 

Matters for recalculation. Subject to the 

limitations on judicial and 

administrative review under section 

1115A of the Act, a HHA may submit a 

request for recalculation under this 

section if it wishes to dispute the 

calculation of the following: 

(i) Interim performance scores. 

(ii) Annual total performance scores. 

(iii) Application of the formula to 

calculate annual payment adjustment 

percentages. 

(2) Time for filing a request for 

recalculation. A recalculation request 

must be submitted in writing within 15 

calendar days after CMS posts the HHAspecific information on the CMS 

website, in a time and manner specified 

by CMS. 

(3) Content of request. (i) The 

provider’s name, address associated 

with the services delivered, and CMS 

Certification Number (CCN). 

(ii) The basis for requesting 

recalculation to include the specific 

data that the HHA believes is inaccurate 

or the calculation the HHA believes is 

incorrect. 

(iii) Contact information for a person 

at the HHA with whom CMS or its agent 

can communicate about this request, 

including name, email address, 

telephone number, and mailing address 

(must include physical address, not just 

a post office box). 

(iv) The HHA may include in the 

request for recalculation additional 

documentary evidence that CMS should 

consider. Such documents may not 

include data that was to have been filed 

by the applicable data submission 

deadline, but may include evidence of 

timely submission. 

(4) Scope of review for recalculation. 

In conducting the recalculation, CMS 

reviews the applicable measures and 

performance scores, the evidence and 

findings upon which the determination 

was based, and any additional 

documentary evidence submitted by the 

HHA. CMS may also review any other 

evidence it believes to be relevant to the 

recalculation. 

(5) Recalculation decision. CMS 

issues a written notification of findings. 

A recalculation decision is subject to the 

request for reconsideration process in 

accordance with paragraph (b) of this 

section. 

(b) Requests for reconsideration—(1) 

Matters for reconsideration. A home 

health agency may request 

reconsideration of the recalculation of 

its annual total performance score and 

payment adjustment percentage 

following a decision on the HHA’s 

recalculation request submitted under 

paragraph (a) of this section, or the 

decision to deny the recalculation 

request submitted under paragraph (a). 

(2) Time for filing a request for 

reconsideration. The request for 

reconsideration must be submitted via 

the CMS website within 15 calendar 

days from CMS’ notification to the HHA 

contact of the outcome of the 

recalculation process. 

(3) Content of request. (i) The name of 

the HHA, address associated with the 

services delivered, and CMS 

Certification Number (CCN). 

(ii) The basis for requesting 

reconsideration to include the specific 

data that the HHA believes is inaccurate 

or the calculation the HHA believes is 

incorrect. 

(iii) Contact information for a person 

at the HHA with whom CMS or its agent 

can communicate about this request, 

including name, email address, 

telephone number, and mailing address 

(must include physical address, not just 

a post office box). 

(iv) The HHA may include in the 

request for reconsideration additional 

documentary evidence that CMS should 

consider. The documents may not 

include data that was to have been filed 

by the applicable data submission 

deadline, but may include evidence of 

timely submission. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36009 

(4) Scope of review for 

reconsideration. In conducting the 

reconsideration review, CMS reviews 

the applicable measures and 

performance scores, the evidence and 

findings upon which the determination 

was based, and any additional 

documentary evidence submitted by the 

HHA. CMS may also review any other 

evidence it believes to be relevant to the 

reconsideration. The HHA must prove 

its case by a preponderance of the 

evidence with respect to issues of fact. 

(5) Reconsideration decision. CMS 

reconsideration officials issue a written 

final determination. 

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

■ 19. The authority citation for part 488 

continues to read as follows: 

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

■ 20. Section 488.2 is amended by 

adding provision ‘‘1822’’ in numerical 

order to read as follows: 

§ 488.2 Statutory basis. 

* * * * * 

1822—Hospice Program survey and 

enforcement procedures. 

* * * * * 

■ 21. Section 488.5 is amended by 

adding paragraph (a)(4)(x) to read as 

follows: 

§ 488.5 Application and re-application 

procedures for national accrediting 

organizations. 

* * * * * 

(a) * * * 

(4) * * * 

(x) For accrediting organizations 

applying for approval or re-approval of 

CMS-approved hospice programs, a 

statement acknowledging that the AO 

will include a statement of deficiencies 

(that is, the Form CMS–2567 or a 

successor form) to document findings of 

the hospice Medicare conditions of 

participation in accordance with section 

1822(a)(2)(A)(ii) of the Act and will 

submit such in a manner specified by 

CMS. 

* * * * * 

■ 22. Section 488.7 is amended by 

revising paragraph (b) by adding 

paragraph (c) to read as follows. 

§ 488.7 Release and use of accreditation 

surveys. 

* * * * * 

(b) With the exception of home health 

agency and hospice program surveys, 

general disclosure of an accrediting 

organization’s survey information is 

prohibited under section 1865(b) of the 

Act. CMS may publicly disclose an 

accreditation survey and information 

related to the survey, upon written 

request, to the extent that the 

accreditation survey and survey 

information are related to an 

enforcement action taken by CMS. 

(c) CMS posts inspection reports from 

a State or local survey agency or 

accreditation organization conducted on 

or after October 1, 2022, for hospice 

programs, including copies of a hospice 

program’s survey deficiencies, and 

enforcement actions (for example, 

involuntary terminations) taken as a 

result of such surveys, on its public 

website in a manner that is prominent, 

easily accessible, readily 

understandable, and searchable for the 

general public and allows for timely 

updates. 

■ 23. Section 488.28 is amended by 

revising the section heading to read as 

follows: 

§ 488.28 Providers or suppliers, other than 

SNFs, NFs, HHAs, and Hospice programs 

with deficiencies. 

* * * * * 

■ 24. Add subparts M and N to read as 

follows: 

Subpart M—Survey and Certification of 

Hospice Programs 

Sec. 

488.1100 Basis and scope. 

488.1105 Definitions. 

488.1110 Hospice program: surveys and 

hotline. 

488.1115 Surveyor qualifications and 

prohibition of conflicts of interest. 

488.1120 Survey teams. 

488.1125 Consistency of survey results. 

488.1130 Special focus program. 

Subpart N—Enforcement Remedies for 

Hospice Programs with Deficiencies 

Sec. 

488.1200 Statutory basis. 

488.1205 Definitions. 

488.1210 General provisions. 

488.1215 Factors to be considered in 

selecting remedies. 

488.1220 Available remedies. 

488.1225 Action when deficiencies pose 

immediate jeopardy. 

488.1230 Action when deficiencies are at 

the condition-level but do not pose 

immediate jeopardy. 

488.1235 Temporary management. 

488.1240 Suspension of all or part of the 

payments. 

488.1245 Civil money penalties. 

488.1250 Directed plan of correction. 

488.1255 Directed in-service training. 

488.1260 Continuation of payments to a 

hospice program with deficiencies. 

488.1265 Termination of provider 

agreement. 

Subpart M—Survey and Certification of 

Hospice Programs 

§ 488.1100 Basis and scope. 

Sections 1812, 1814, 1822, 1861, 

1864, and 1865 of the Act establish 

requirements for Hospice programs and 

to authorize surveys to determine 

whether they meet the Medicare 

conditions of participation. 

§ 488.1105 Definitions. 

As used in this subpart— 

Abbreviated standard survey means a 

focused survey other than a standard 

survey that gathers information on 

hospice program’s compliance with 

specific standards or conditions of 

participation. An abbreviated standard 

survey may be based on complaints 

received or other indicators of specific 

concern. 

Complaint survey means a survey that 

is conducted to investigate substantial 

allegations of noncompliance as defined 

in § 488.1. 

Condition-level deficiency means 

noncompliance as described in § 488.24. 

Deficiency is a violation of the Act 

and regulations contained in part 418, 

subparts C and D of this chapter, is 

determined as part of a survey, and can 

be either standard or condition-level. 

Noncompliance means any deficiency 

found at the condition-level or standardlevel. 

Standard-level deficiency means 

noncompliance with one or more of the 

standards that make up each condition 

of participation for hospice programs. 

Standard survey means a survey 

conducted in which the surveyor 

reviews the hospice program’s 

compliance with a select number of 

standards or conditions of participation 

or both to determine the quality of care 

and services furnished by a hospice 

program. 

Substantial compliance means 

compliance with all condition-level 

requirements, as determined by CMS or 

the State. 

§ 488.1110 Hospice program: surveys and 

hotline. 

(a) Basic period. Each hospice 

program as defined in section 1861(dd) 

of the Act is subject to a standard survey 

by an appropriate State or local survey 

agency, or an approved accreditation 

agency, as determined by the Secretary, 

not less frequently than once every 36 

months. Additionally, a survey may be 

conducted as frequently as necessary 

to— 

(1) Assure the delivery of quality 

hospice program services by 

determining whether a hospice program 

complies with the Act and conditions of 

participation; and 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36010 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

(2) Confirm that the hospice program 

has corrected deficiencies that were 

previously cited. 

(b) Complaints. A standard survey, or 

abbreviated standard survey— 

(1) Must be conducted of a hospice 

program when complaints against the 

hospice program are reported to CMS, 

the State, or local agency. 

(2) The State, or local agency is 

responsible for maintaining a toll-free 

hotline to collect, maintain, and 

continually update information on 

Medicare-participating hospice 

programs including significant 

deficiencies found regarding patient 

care, corrective actions, and remedy 

activity during its most recent survey, 

and to receive complaints and answer 

questions about hospice programs. The 

State or local agency is also responsible 

for maintaining a unit for investigating 

such complaints. 

§ 488.1115 Surveyor qualifications and 

prohibition of conflicts of interest. 

(a) Minimum qualifications: 

Surveyors must meet minimum 

qualifications prescribed by CMS. 

Before any accrediting organization, 

State or Federal surveyor may serve on 

a hospice survey team (except as a 

trainee), he/she must have successfully 

completed the relevant CMS-sponsored 

Basic Hospice Surveyor Training 

Course, and additional training as 

specified by CMS. 

(b) Disqualifications. Any of the 

following circumstances disqualifies a 

surveyor from surveying a particular 

hospice program: 

(1) The surveyor currently serves, or, 

within the previous 2 years has served, 

with the hospice program to be 

surveyed as one of the following: 

(i) A direct employee. 

(ii) An employment agency staff at the 

hospice program. 

(iii) An officer, consultant, or agent 

for the hospice program to be surveyed 

concerning compliance with conditions 

of participation specified in or in 

accordance with sections 1861(dd) of 

the Act. 

(2) The surveyor has a financial 

interest or an ownership interest in the 

hospice program to be surveyed. 

(3) The surveyor has an immediate 

family member, as defined at. § 411.351 

of this chapter, who has a financial 

interest or an ownership interest with 

the hospice program to be surveyed. 

(4) The surveyor has an immediate 

family member, as defined at § 411.351 

of this chapter, who is a patient of the 

hospice program to be surveyed. 

§ 488.1120 Survey teams. 

Standard surveys conducted by more 

than one surveyor must be conducted by 

a multidisciplinary team of 

professionals typically involved in 

hospice care and identified as 

professionals providing hospice core 

services at § 418.64 of this chapter. The 

multidisciplinary team must include a 

registered nurse. Surveys conducted by 

a single surveyor, must be conducted by 

a registered nurse. 

§ 488.1125 Consistency of survey results. 

A survey agency or accrediting 

organization must provide a corrective 

action plan to CMS for any disparity 

rates that are greater than the threshold 

established by CMS. 

§ 488.1130 Special focus program. 

(a) In general.—The Secretary must 

conduct a special focus program for the 

enforcement of conditions of 

participation for hospice programs that 

the Secretary has identified as having 

substantially failed to meet applicable 

requirements for Medicare participation. 

(b) Criteria for inclusion in the 

hospice special focus program. (1) A 

hospice program may be required to 

participate in a special focus program if 

any one of the following criteria exists: 

(i) The hospice program is found to be 

deficient with condition-level findings 

during two consecutive standard 

surveys. 

(ii) The hospice program is found to 

be deficient with condition-level 

findings during two consecutive 

complaint surveys. 

(iii) The hospice program is found to 

be deficient with two or more conditionlevel findings during a validation 

survey. 

(2) CMS provides the State survey 

agencies with a list of hospice programs 

identified as meeting the criteria for 

inclusion in the special focus program. 

A program that meets the criteria will be 

placed on the special focus program 

candidate list and selected for the 

program as specified by CMS. 

(c) Periodic surveys. The State Survey 

Agency, on CMS’s behalf, conducts an 

onsite survey of each hospice in the 

program not less than once every 6 

months to examine all the Medicare 

hospice program conditions of 

participation and recommend 

progressive enforcement in accordance 

with an enforcement remedy or 

remedies until the hospice program 

either of the following: 

(1) Graduates from the special focus 

program by coming back into full 

compliance with the hospice conditions 

of participation on two consecutive 6- 

month surveys. 

(2) Is terminated from the Medicare or 

Medicaid or both programs. 

Subpart N—Enforcement Remedies for 

Hospice Programs with Deficiencies 

§ 488.1200 Statutory basis. 

Section 1822 of the Act authorizes the 

Secretary to take actions to remove and 

correct deficiencies in a hospice 

program through an enforcement 

remedy or termination or both. This 

section specifies that these remedies are 

in addition to any others available 

under State or Federal law, and, except 

for the final determination of civil 

money penalties, are imposed prior to 

the conduct of a hearing. 

§ 488.1205 Definitions. 

As used in this subpart— 

Directed plan of correction means 

CMS or the temporary manager (with 

CMS/SA approval) may direct the 

hospice program to take specific 

corrective action to achieve specific 

outcomes within specific timeframes. 

Immediate jeopardy means a situation 

in which the provider’s noncompliance 

with one or more requirements of 

participation has caused, or is likely to 

cause, serious injury, harm, impairment, 

or death to a patient(s). 

New admission means an individual 

who becomes a patient or is readmitted 

to the hospice program on or after the 

effective date of a suspension of 

payment remedy. 

Per instance means a single event of 

noncompliance identified and corrected 

during a survey, for which the statute 

authorizes CMS to impose a remedy. 

Plan of correction means a plan 

developed by the hospice program and 

approved by CMS that is the hospice 

program’s written response to survey 

findings detailing corrective actions to 

cited deficiencies and specifies the date 

by which those deficiencies will be 

corrected. 

Repeat deficiency means a conditionlevel deficiency that is cited on the 

current survey and is substantially the 

same as or similar to, a finding of a 

standard-level or condition-level 

deficiency cited on the most recent 

previous standard survey or on any 

intervening survey since the most recent 

standard survey. Repeated noncompliance is not on the basis that the 

exact regulation (that is, tag number) for 

the deficiency was repeated. 

Temporary management means the 

temporary appointment by CMS or by a 

CMS authorized agent, of a substitute 

manager or administrator. The hospice 

program’s governing body must ensure 

that the temporary manager has 

authority to hire, terminate or reassign 

staff, obligate funds, alter procedures, 

and manage the hospice program to 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36011 

correct deficiencies identified in the 

hospice program’s operation. 

§ 488.1210 General provisions. 

(a) Purpose of remedies. The purpose 

of remedies is to ensure prompt 

compliance with program requirements 

in order to protect the health and safety 

of individuals under the care of a 

hospice program. 

(b) Basis for imposition of remedies. 

When CMS chooses to apply one or 

more remedies specified in § 488.1220, 

the remedies are applied on the basis of 

noncompliance with one or more 

conditions of participation and may be 

based on failure to correct previous 

deficiency findings as evidenced by 

repeat condition-level deficiencies. 

(c) Number of remedies. CMS may 

impose one or more remedies specified 

in § 488.1220 of this part for each 

condition-level deficiency constituting 

noncompliance. 

(d) Plan of correction requirement. 

Regardless of which remedy is applied, 

a non-compliant hospice program must 

submit a plan of correction for approval 

by CMS or the State Survey Agency. 

(e) Notification requirements—(1) 

Notice of intent. CMS provides written 

notification to the hospice program of 

the intent to impose the remedy, the 

statutory basis for the remedy, the 

nature of the noncompliance, the 

proposed effective date of the sanction, 

and the appeal rights. For payment 

suspensions, the notice of intent would 

also identify which payments are being 

suspended, and for civil money 

penalties, the notice of intent would 

also include the amount being imposed. 

(2) Final notice. With respect to civil 

money penalties, CMS provides a 

written final notice to the hospice 

program, as set forth in § 488.1245(e), 

once the administrative determination is 

final. 

(3) Date of enforcement action. The 

notice periods specified in § 488.1225(b) 

and § 488.1230(b) begin the day after the 

hospice receives the notice of intent. 

(f) Appeals. (1) The hospice program 

may request a hearing on a 

determination of noncompliance 

leading to the imposition of a remedy, 

including termination of the provider 

agreement, under the provisions of part 

498 of this chapter. 

(2) A pending hearing does not delay 

the effective date of a remedy, including 

termination, against a hospice program. 

Remedies continue to be in effect 

regardless of the timing of any appeals 

proceedings. 

§ 488.1215 Factors to be considered in 

selecting remedies. 

CMS bases its choice of remedy or 

remedies on consideration of one or 

more factors that include, but are not 

limited to, the following: 

(a) The extent to which the 

deficiencies pose immediate jeopardy to 

patient health and safety. 

(b) The nature, incidence, manner, 

degree, and duration of the deficiencies 

or noncompliance. 

(c) The presence of repeat 

deficiencies, the hospice program’s 

overall compliance history and any 

history of repeat deficiencies at either 

the parent hospice program or any of its 

multiple locations. 

(d) The extent to which the 

deficiencies are directly related to a 

failure to provide quality patient care. 

(e) The extent to which the hospice 

program is part of a larger organization 

with performance problems. 

(f) An indication of any system-wide 

failure to provide quality care. 

§ 488.1220 Available remedies. 

The following enforcement remedies 

are available instead of, or in addition 

to, termination of the hospice program’s 

provider agreement under § 489.53, for 

a period not to exceed 6 months: 

(a) Civil money penalties. 

(b) Suspension of payment for all or 

part of the payments. 

(c) Temporary management of the 

hospice program. 

(d) Directed plan of correction. 

(e) Directed in-service training. 

§ 488.1225 Action when deficiencies pose 

immediate jeopardy. 

(a) Immediate jeopardy. If there is 

immediate jeopardy to the hospice 

program’s patient health or safety, the 

following rules apply: 

(1) CMS immediately terminates the 

hospice program provider agreement in 

accordance with § 489.53 of this 

chapter. 

(2) CMS terminates the hospice 

program provider agreement no later 

than 23 calendar days from the last day 

of the survey, if the immediate jeopardy 

has not been removed by the hospice 

program. 

(3) In addition to a termination, CMS 

may impose one or more enforcement 

remedies, as appropriate. 

(b) 2-day notice. Except for civil 

money penalties, for all remedies 

specified in § 488.1220 imposed when 

there is immediate jeopardy, notice 

must be given at least 2 calendar days 

before the effective date of the 

enforcement action. The requirements of 

the notice are set forth in § 488.1225(e). 

(c) Transfer of care. A hospice 

program, if its provider agreement is 

terminated, is responsible for providing 

information, assistance, and 

arrangements necessary for the proper 

and safe transfer of patients to another 

local hospice program within 30 

calendar days of termination. 

§ 488.1230 Action when deficiencies are at 

the condition-level but do not pose 

immediate jeopardy. 

(a) Noncompliance with conditions of 

participation. If the hospice program is 

no longer in compliance with the 

conditions of participation, either 

because the condition-level deficiency 

or deficiencies substantially limit the 

provider’s capacity to furnish adequate 

care but do not pose immediate 

jeopardy, or the hospice program has 

repeat condition-level deficiencies 

based on the hospice program’s failure 

to correct and sustain compliance, CMS 

does either of the following. 

(1) Terminates the hospice program’s 

provider agreement. 

(2) Imposes one or more enforcement 

remedies set forth in § 488.1220(a) 

through (e) in lieu of termination, for a 

period not to exceed 6 months. 

(b) 15-day notice. Except for civil 

money penalties, for all remedies 

specified in § 488.1220 imposed when 

there is no immediate jeopardy, notice 

must be given at least 15 calendar days 

before the effective date of the 

enforcement action. The requirements of 

the notice are set forth in § 488.1210(e). 

(c) Not meeting criteria for 

continuation of payment. If a hospice 

program does not meet the criteria for 

continuation of payment under 

§ 488.1260(a), CMS terminates the 

hospice program’s provider agreement 

in accordance with § 488.1265. 

(d) Termination timeframe when there 

is no immediate jeopardy. CMS 

terminates a hospice program within 6 

months of the last day of the survey, if 

the hospice program is not in 

compliance with the conditions of 

participation, and the terms of the plan 

of correction have not been met. 

(e) Transfer of care. A hospice 

program, if its provider agreement 

terminated, is responsible for providing 

information, assistance, and 

arrangements necessary for the proper 

and safe transfer of patients to another 

local hospice program within 30 

calendar days of termination. The State 

must assist the hospice program in the 

safe and orderly transfer of care and 

services for the patients to another local 

hospice program. 

§ 488.1235 Temporary management. 

(a) Application. (1) CMS may impose 

temporary management of a hospice 

program if it determines that a hospice 

program has a condition-level 

deficiency and CMS determines that 

management limitations or the 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36012 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

deficiencies are likely to impair the 

hospice program’s ability to correct the 

noncompliance and return the hospice 

program to compliance with all of the 

conditions of participation within the 

timeframe required. 

(b) Procedures—(1) Notice of intent. 

Before imposing this remedy, CMS 

notifies the hospice program in 

accordance with § 488.1210(e) that a 

temporary manager is being appointed. 

(2) Termination. If the hospice 

program fails to relinquish authority 

and control to the temporary manager, 

CMS terminates the hospice program’s 

provider agreement in accordance with 

§ 488.1265. 

(c) Duration and effect of remedy. 

Temporary management continues until 

one of the following occur: 

(1) CMS determines that the hospice 

program has achieved substantial 

compliance and has the management 

capability to ensure continued 

compliance with all the conditions of 

participation. 

(2) CMS terminates the provider 

agreement. 

(3) The hospice program resumes 

management control without CMS 

approval. In this case, CMS initiates 

termination of the provider agreement 

and may impose additional remedies. 

(4) Temporary management will not 

exceed a period of 6 months from the 

date of the survey identifying 

noncompliance. 

(d) Payment of salary. (1) The 

temporary manager’s salary must meet 

the following: 

(i) Is paid directly by the hospice 

program while the temporary manager is 

assigned to that hospice program. 

(ii) Must be at least equivalent to the 

sum of the following: 

(A) The prevailing salary paid by 

providers for positions of this type in 

what the State considers to be the 

hospice program’s geographic area 

(prevailing salary based on the Bureau 

of Labor Statistics, National 

Occupational Employment and Wage 

Estimates)). 

(B) Any additional costs that would 

have reasonably been incurred by the 

hospice program if such person had 

been in an employment relationship. 

(C) Any other costs incurred by such 

a person in furnishing services under 

such an arrangement or as otherwise set 

by the State. 

(2) A hospice program’s failure to pay 

the salary and other costs of the 

temporary manager described in 

paragraph (d)(1) of this section is 

considered a failure to relinquish 

authority and control to temporary 

management. 

§ 488.1240 Suspension of all or part of the 

payments. 

(a) Application. (1) CMS may suspend 

all or part of the payments to which a 

hospice program would otherwise be 

entitled with respect to items and 

services furnished by a hospice program 

on or after the date on which the 

Secretary determines that remedies 

should be imposed. 

(2) CMS considers this remedy for any 

deficiency related to poor patient care 

outcomes, regardless of whether the 

deficiency poses immediate jeopardy. 

(b) Procedures—(1) Notice of intent. 

(i) Before suspending payments, CMS 

provides the hospice program notice of 

the suspension of payment in 

accordance with § 488.1210(e). 

(ii) The hospice program may not 

charge a newly admitted hospice patient 

who is a Medicare beneficiary for 

services for which Medicare payment is 

suspended unless the hospice program 

can show that, before initiating care, it 

gave the patient or his or her 

representative oral and written notice of 

the suspension of Medicare payment in 

a language and manner that the 

beneficiary or representative can 

understand. 

(2) Restriction. (i) Suspension of 

payment remedy may be imposed 

anytime a hospice program is found to 

be out of substantial compliance with 

the conditions of participation. 

(ii) Suspension of payment remains in 

place until CMS determines that the 

hospice program has achieved 

substantial compliance with the 

conditions of participation or is 

terminated, as determined by CMS. 

(3) Resumption of payments. 

Payments to the hospice program 

resume prospectively on the date that 

CMS determines that the hospice 

program has achieved substantial 

compliance with the conditions of 

participation. 

(c) Duration and effect of remedy. 

This remedy ends when any of the 

following occur: 

(1) CMS determines that the hospice 

program has achieved substantial 

compliance with all of the conditions of 

participation. 

(2) When the hospice program is 

terminated or CMS determines that the 

hospice program is not in compliance 

with the conditions of participation at a 

maximum of 6 months from the date of 

the survey identifying the 

noncompliance. 

§ 488.1245 Civil money penalties. 

(a) Application. (1) CMS may impose 

a civil money penalty against a hospice 

program for either the number of days 

the hospice program is not in 

compliance with one or more conditions 

of participation or for each instance that 

a hospice program is not in compliance, 

regardless of whether the hospice 

program’s deficiencies pose immediate 

jeopardy. 

(2) CMS may impose a civil money 

penalty for the number of days of 

immediate jeopardy. 

(3) A per-day and a per-instance CMP 

may not be imposed simultaneously for 

the same deficiency in conjunction with 

a survey. 

(4) CMS may impose a civil money 

penalty for the number of days of 

noncompliance since the last standard 

survey, including the number of days of 

immediate jeopardy. 

(b) Amount of penalty—(1) Factors 

considered. CMS takes into account the 

following factors in determining the 

amount of the penalty: 

(i) The factors set out at § 488.1215. 

(ii) The size of a hospice program and 

its resources. 

(iii) Evidence that the hospice 

program has a built-in, self-regulating 

quality assessment and performance 

improvement system to provide proper 

care, prevent poor outcomes, control 

patient injury, enhance quality, promote 

safety, and avoid risks to patients on a 

sustainable basis that indicates the 

ability to meet the conditions of 

participation and to ensure patient 

health and safety. 

(2) Adjustments to penalties. Based on 

revisit survey findings, adjustments to 

penalties may be made after a review of 

the provider’s attempted correction of 

deficiencies. 

(i) CMS may increase a CMP in 

increments based on a hospice 

program’s inability or failure to correct 

deficiencies, the presence of a systemwide failure in the provision of quality 

care, or a determination of immediate 

jeopardy with actual harm versus 

immediate jeopardy with potential for 

harm. 

(ii) CMS may also decrease a CMP in 

increments to the extent that it finds, in 

accordance with a revisit, that 

substantial and sustainable 

improvements have been implemented 

even though the hospice program is not 

yet in compliance with the conditions of 

participation. 

(iii) No penalty assessment exceeds 

$10,000, as adjusted annually under 45 

CFR part 102, for each day a hospice 

program is not in substantial 

compliance with one or more conditions 

of participation. 

(3) Upper range of penalty. Penalties 

in the upper range of $8,500 to $10,000 

per day, as adjusted annually under 45 

CFR part 102, are imposed for a 

condition-level deficiency that is 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36013 

immediate jeopardy. The penalty in this 

range continues until substantial 

compliance can be determined based on 

a revisit survey. 

(i) $10,000, as adjusted annually 

under 45 CFR part 102, per day for a 

deficiency or deficiencies that are 

immediate jeopardy and that result in 

actual harm. 

(ii) $9,000, as adjusted annually under 

45 CFR part 102, per day for a 

deficiency or deficiencies that are 

immediate jeopardy and that result in a 

potential for harm. 

(iii) $8,500, as adjusted annually 

under 45 CFR part 102, per day for a 

deficiency based on an isolated incident 

in violation of established hospice 

policy. 

(4) Middle range of penalty. Penalties 

in the range of $1,500 up to $8,500, as 

adjusted annually under 45 CFR part 

102, per day of noncompliance are 

imposed for a repeat or condition-level 

deficiency or both that does not 

constitute immediate jeopardy but is 

directly related to poor quality patient 

care outcomes. 

(5) Lower range of penalty. Penalties 

in this range of $500 to $4,000, as 

adjusted annually under 45 CFR part 

102, are imposed for a repeat or 

condition-level deficiency or both that 

does not constitute immediate jeopardy 

and that are related predominately to 

structure or process-oriented conditions 

rather than directly related to patient 

care outcomes. 

(6) Per instance penalty. Penalty 

imposed per instance of noncompliance 

may be assessed for one or more 

singular events of condition-level 

deficiency that are identified and where 

the noncompliance was corrected 

during the onsite survey. When 

penalties are imposed for per instance of 

noncompliance, or more than one per 

instance of noncompliance, the 

penalties will be in the range of $1,000 

to $10,000 per instance, not to exceed 

$10,000 each day of noncompliance, as 

adjusted annually under 45 CFR part 

102. 

(7) Decreased penalty amounts. If the 

immediate jeopardy situation is 

removed, but a condition-level 

deficiency exists, CMS shifts the penalty 

amount imposed per day from the upper 

range to the middle or lower range. An 

earnest effort to correct any systemic 

causes of deficiencies and sustain 

improvement must be evident. 

(8) Increased penalty amounts. (i) In 

accordance with paragraph (b)(2) of this 

section, CMS increases the per day 

penalty amount for any condition-level 

deficiency or deficiencies which, after 

imposition of a lower-level penalty 

amount, become sufficiently serious to 

pose potential harm or immediate 

jeopardy. 

(ii) CMS increases the per day penalty 

amount for deficiencies that are not 

corrected and found again at the time of 

revisit survey(s) for which a lower-level 

penalty amount was previously 

imposed. 

(iii) CMS may impose a more severe 

amount of penalties for repeated 

noncompliance with the same 

condition-level deficiency or 

uncorrected deficiencies from a prior 

survey. 

(c) Procedures—(1) Notice of intent. 

CMS provides the hospice program with 

written notice of the intent to impose a 

civil money penalty in accordance with 

§ 488.1210(e). 

(2) Appeals—(i) Appeals procedures. 

A hospice program may request a 

hearing on the determination of the 

noncompliance that is the basis for 

imposition of the civil money penalty. 

The request must meet the requirements 

in § 498.40 of this chapter. 

(ii) Waiver of a hearing. A hospice 

program may waive the right to a 

hearing, in writing, within 60 calendar 

days from the date of the notice 

imposing the civil money penalty. If a 

hospice program timely waives its right 

to a hearing, CMS reduces the penalty 

amount by 35 percent, and the amount 

is due within 15 calendar days of the 

hospice program agreeing in writing to 

waive the hearing. If the hospice 

program does not waive its right to a 

hearing in accordance to the procedures 

specified in this section, the civil money 

penalty is not reduced by 35 percent. 

(d) Accrual and duration of penalty— 

(1) Accural of per day penalty. (i) The 

per day civil money penalty may start 

accruing as early as the beginning of the 

last day of the survey that determines 

that the hospice program was out of 

compliance, as determined by CMS. 

(ii) A civil money penalty for each per 

instance of noncompliance is imposed 

in a specific amount for that particular 

deficiency, with a maximum of $10,000 

per day per hospice program. 

(2) Duration of per day penalty when 

there is immediate jeopardy. (i) In the 

case of noncompliance that poses 

immediate jeopardy, CMS must 

terminate the provider agreement within 

23 calendar days after the last day of the 

survey if the immediate jeopardy is not 

removed. 

(ii) A penalty imposed per day of 

noncompliance will stop accruing on 

the day the provider agreement is 

terminated or the hospice program 

achieves substantial compliance, 

whichever occurs first. 

(3) Duration of penalty when there is 

no immediate jeopardy. (i) In the case of 

noncompliance that does not pose 

immediate jeopardy, the daily accrual of 

per day civil money penalties is 

imposed for the days of noncompliance 

prior to the notice of intent specified in 

paragraph (c)(1) of this section and an 

additional period of no longer than 6 

months following the last day of the 

survey. 

(ii) If the hospice program has not 

achieved compliance with the 

conditions of participation within 6 

months following the last day of the 

survey, CMS terminates the provider 

agreement. The accrual of civil money 

penalty stops on the day the hospice 

program agreement is terminated or the 

hospice program achieves substantial 

compliance, whichever is earlier. 

(e) Computation and notice of total 

penalty amount. (1) When a civil money 

penalty is imposed on a per day basis 

and the hospice program achieves 

compliance with the conditions of 

participation as determined by a revisit 

survey, once the administrative 

determination is final, CMS sends a 

final notice to the hospice program 

containing of the following information: 

(i) The amount of penalty assessed per 

day. 

(ii) The total number of days of 

noncompliance. 

(iii) The total amount due. 

(iv) The due date of the penalty. 

(v) The rate of interest to be assessed 

on any unpaid balance beginning on the 

due date, as provided in paragraph (f)(6) 

of this section. 

(2) When a civil money penalty is 

imposed per instance of noncompliance, 

once the administrative determination is 

final, CMS sends a final notice to the 

hospice program containing all of the 

following information: 

(i) The amount of the penalty that was 

assessed. 

(ii) The total amount due. 

(iii) The due date of the penalty. 

(iv) The rate of interest to be assessed 

on any unpaid balance beginning on the 

due date, as provided in paragraph (f)(6) 

of this section. 

(3) In the case of a hospice program 

for which the provider agreement has 

been involuntarily terminated, CMS 

sends the final notice after one of the 

following actions has occurred: 

(i) The administrative determination 

is final. 

(ii) The hospice program has waived 

its right to a hearing in accordance with 

paragraph (c)(2)(ii) of this section. 

(iii) Time for requesting a hearing has 

expired and the hospice program has 

not requested a hearing. 

(f) Due date for payment of penalty. 

A penalty is due and payable 15 

calendar days from notice of the final 

administrative decision. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36014 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

(1) Payments are due for all civil 

money penalties within 15 calendar 

days of any of the following: 

(i) After a final administrative 

decision when the hospice program 

achieves substantial compliance before 

the final decision or the effective date of 

termination occurs before the final 

decision. 

(ii) After the time to appeal has 

expired and the hospice program does 

not appeal or fails to timely appeal the 

initial determination. 

(iii) After CMS receives a written 

request from the hospice program 

requesting to waive its right to appeal 

the determinations that led to the 

imposition of a remedy. 

(iv) After the effective date of 

termination. 

(2) A request for hearing does not 

delay the imposition of any penalty; it 

only potentially delays the collection of 

the final penalty amount. 

(3) If a hospice program waives its 

right to a hearing according to paragraph 

(c)(2)(ii) of this section, CMS applies a 

35 percent reduction to the CMP 

amount for any of the following: 

(i) The hospice program achieved 

compliance with the conditions of 

participation before CMS received the 

written waiver of hearing. 

(ii) The effective date of termination 

occurs before CMS received the written 

waiver of hearing. 

(4) The period of noncompliance may 

not extend beyond 6 months from the 

last day of the survey. 

(5) The amount of the penalty, when 

determined, may be deducted (offset) 

from any sum then or later owing by 

CMS or State Medicaid to the hospice 

program. 

(6) Interest is assessed and accrues on 

the unpaid balance of a penalty, 

beginning on the due date. Interest is 

computed at the rate specified in 

§ 405.378(d) of this chapter. 

(g) Review of the penalty. When an 

administrative law judge finds that the 

basis for imposing a civil monetary 

penalty exists, as specified in this part, 

the administrative law judge, may not 

do any of the following: 

(1) Set a penalty of zero or reduce a 

penalty to zero. 

(2) Review the exercise of discretion 

by CMS to impose a civil monetary 

penalty. 

(3) Consider any factors in reviewing 

the amount of the penalty other than 

those specified in paragraph (b) of this 

section. 

§ 488.1250 Directed plan of correction. 

(a) Application. CMS may impose a 

directed plan of correction when a 

hospice program— 

(1) Has one or more condition-level 

deficiencies that warrant directing the 

hospice program to take specific actions; 

or 

(2) Fails to submit an acceptable plan 

of correction. 

(b) Procedures. (1) Before imposing 

this remedy, CMS notifies the hospice 

program in accordance with 

§ 488.1210(e). 

(2) CMS or the temporary manager 

(with CMS approval) may direct the 

hospice program to take corrective 

action to achieve specific outcomes 

within specific timeframes. 

(c) Duration and effect of remedy. If 

the hospice program fails to achieve 

compliance with the conditions of 

participation within the timeframes 

specified in the directed plan of 

correction, which may not to exceed 6 

months, CMS does one of the following: 

(1) May impose one or more other 

remedies set forth in § 488.1220. 

(2) Terminates the provider 

agreement. 

§ 488.1255 Directed in-service training. 

(a) Application. CMS may require the 

staff of a hospice program to attend inservice training program(s) if CMS 

determines all of the following: 

(1) The hospice program has 

condition-level deficiencies. 

(2) Education is likely to correct the 

deficiencies. 

(3) The programs are conducted by 

established centers of health education 

and training or consultants with 

background in education and training 

with Medicare hospice providers, or as 

deemed acceptable by CMS or the State 

(by review of a copy of curriculum vitas 

or resumes and references to determine 

the educator’s qualifications). 

(b) Procedures—(1) Notice of intent. 

Before imposing this remedy, CMS 

notifies the hospice program in 

accordance with § 488.1210(e). 

(2) Action following training. After the 

hospice program staff has received inservice training, if the hospice program 

has not achieved substantial 

compliance, CMS may impose one or 

more other remedies specified in 

§ 488.1220. 

(3) Payment. The hospice program 

pays for the directed in-service training 

for its staff. 

§ 488.1260 Continuation of payments to a 

hospice program with deficiencies. 

(a) Continued payments. CMS may 

continue payments to a hospice program 

with condition-level deficiencies that do 

not constitute immediate jeopardy for 

up to 6 months from the last day of the 

survey if the criteria in paragraph (a)(1) 

of this section are met. 

(1) Criteria. CMS may continue 

payments to a hospice program not in 

compliance with the conditions of 

participation for the period specified in 

paragraph (a) of this section if all of the 

following criteria are met: 

(i) An enforcement remedy, or 

remedies, (with the exception of 

suspension of all payment) has been 

imposed on the hospice program and 

termination has not been imposed. 

(ii) The hospice program has 

submitted a plan of correction approved 

by CMS. 

(iii) The hospice program agrees to 

repay the Federal government payments 

received under this provision if 

corrective action is not taken in 

accordance with the approved plan and 

timetable for corrective action. 

(2) Termination. CMS may terminate 

the hospice program’s provider 

agreement any time if the criteria in 

paragraph (a)(1) of this section are not 

met. 

(b) Cessation of payments for new 

admissions. If termination is imposed, 

either on its own or in addition to an 

enforcement remedy or remedies, or if 

any of the criteria set forth in paragraph 

(a)(1) of this section are not met, the 

hospice program will receive no 

Medicare payments, as applicable, for 

new admissions following the last day 

of the survey. 

(c) Failure to achieve compliance with 

the conditions of participation. If the 

hospice program does not achieve 

compliance with the conditions of 

participation by the end of the period 

specified in paragraph (a) of this 

section, CMS terminates the provider 

agreement of the hospice program in 

accordance with § 488.1265. 

§ 488.1265 Termination of provider 

agreement. 

(a) Effect of termination by CMS. 

Termination of the provider agreement 

ends— 

(1) Payment to the hospice program; 

and 

(2) Any enforcement remedy. 

(b) Basis for termination. CMS 

terminates a hospice program’s provider 

agreement under any one of the 

following conditions: 

(1) The hospice program is not in 

compliance with the conditions of 

participation. 

(2) The hospice program fails to 

submit an acceptable plan of correction 

within the timeframe specified by CMS. 

(3) The hospice program fails to 

relinquish control to the temporary 

manager, if that remedy is imposed by 

CMS. 

(4) The hospice program fails to meet 

the eligibility criteria for continuation of 

payment as set forth in § 488.1260(a)(1). 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 36015 

(c) Notice. CMS notifies the hospice 

program and the public of the 

termination, in accordance with 

procedures set forth in § 489.53 of this 

chapter. 

(d) Procedures for termination. CMS 

terminates the provider agreement in 

accordance with procedures set forth in 

§ 489.53 of this chapter. 

(e) Payment post termination. 

Payment is available for up to 30 

calendar days after the effective date of 

termination for hospice care furnished 

under a plan established before the 

effective date of termination as set forth 

in § 489.55 of this chapter. 

(f) Appeal. A hospice program may 

appeal the termination of its provider 

agreement by CMS in accordance with 

part 498 of this chapter. 

PART 489—PROVIDER AGREEMENTS 

AND SUPPLIER APPROVAL 

■ 25. The authority citation for part 489 

continues to read as follows: 

Authority: 42 U.S.C. 1302, 1395i–3, 1395x, 

1395aa(m), 1395cc, 1395ff, and 1395(hh). 

■ 26. Section 489.28 is amended by 

revising paragraphs (d) and (e) to read 

as follows: 

§ 489.28 Special capitalization 

requirements for HHAs 

* * * * * 

(d) Required proof of availability of 

initial reserve operating funds. The 

HHA must provide CMS with adequate 

proof of the availability of initial reserve 

operating funds. Such proof, at a 

minimum, will include a copy of the 

statement(s) of the HHA’s savings, 

checking, or other account(s) that 

contains the funds, accompanied by an 

attestation from an officer of the bank or 

other financial institution (if the 

financial institution offers such 

attestations) that the funds are in the 

account(s) and that the funds are 

immediately available to the HHA. In 

some cases, an HHA may have all or 

part of the initial reserve operating 

funds in cash equivalents. For the 

purpose of this section, cash equivalents 

are short-term, highly liquid 

investments that are readily convertible 

to known amounts of cash and that 

present insignificant risk of changes in 

value. A cash equivalent that is not 

readily convertible to a known amount 

of cash as needed during the initial 3- 

month period for which the initial 

reserve operating funds are required 

does not qualify in meeting the initial 

reserve operating funds requirement. 

Examples of cash equivalents for the 

purpose of this section are Treasury 

bills, commercial paper, and money 

market funds. As with funds in a 

checking, savings, or other account, the 

HHA also must be able to document the 

availability of any cash equivalents. 

CMS later may require the HHA to 

furnish another attestation from the 

financial institution that the funds 

remain available, or, if applicable, 

documentation from the HHA that any 

cash equivalents remain available, until 

a date when the HHA will have been 

surveyed by the State agency or by an 

approved accrediting organization. The 

officer of the HHA who will be 

certifying the accuracy of the 

information on the HHA’s cost report 

must certify what portion of the 

required initial reserve operating funds 

is non-borrowed funds, including funds 

invested in the business by the owner. 

That amount must be at least 50 percent 

of the required initial reserve operating 

funds. The remainder of the reserve 

operating funds may be secured through 

borrowing or line of credit from an 

unrelated lender. 

(e) Borrowed funds. If borrowed funds 

are not in the same account(s) as the 

HHA’s own non-borrowed funds, the 

HHA also must provide proof that the 

borrowed funds are available for use in 

operating the HHA, by providing, at a 

minimum, a copy of the statement(s) of 

the HHA’s savings, checking, or other 

account(s) containing the borrowed 

funds, accompanied by an attestation 

from an officer of the bank or other 

financial institution (if the financial 

institution offers such attestations) that 

the funds are in the account(s) and are 

immediately available to the HHA. As 

with the HHA’s own (that is, nonborrowed) funds, CMS later may require 

the HHA to establish the current 

availability of such borrowed funds, 

including furnishing an attestation from 

a financial institution or other source, as 

may be appropriate, and to establish 

that such funds will remain available 

until a date when the HHA will have 

been surveyed by the State agency or by 

an approved accrediting organization. 

* * * * * 

§ 489.53 [Amended] 

■ 27. Section 489.53 is amended in 

paragraph (a)(17) by removing the 

phrase ‘‘an HHA,’’ and adding in its 

place the phrase ‘‘an HHA or hospice 

program,’’. 

PART 498—APPEALS PROCEDURES 

FOR DETERMINATIONS THAT AFFECT 

PARTICIPATION IN THE MEDICARE 

PROGRAM AND FOR 

DETERMINATIONS THAT AFFECT THE 

PARTICIPATION OF ICFS/IID AND 

CERTAIN NFs IN THE MEDICAID 

PROGRAM 

■ 28. The authority citation for part 498 

continues to read as follows: 

Authority: 42 U.S.C. 1302, 1320a–7j, and 

1395hh. 

■ 29. Section 498.1 is amended by 

adding paragraph (l) to read as follows: 

§ 498.1 Statutory basis. 

* * * * * 

(l) Section 1822 of the Act provides 

that for hospice programs that are no 

longer in compliance with the 

conditions of participation, the 

Secretary may develop remedies to be 

imposed instead of, or in addition to, 

termination of the hospice program’s 

Medicare provider agreement. 

■ 30. Section 498.3 is amended— 

■ a. By revising paragraph (b)(13); 

■ b. In paragraph (b)(14) introductory 

text, by removing the phrase ‘‘NF or 

HHA but only’’ and adding in its place 

the phrase ‘‘NF, HHA or hospice 

program, but only’’; 

■ c. By revising paragraph (b)(14)(i); and 

■ d. In paragraph (d)(10) introductory 

text, by removing the phrase ‘‘NF or 

HHA—’’ and adding in its place the 

phrase ‘‘NF, HHA or hospice program— 

‘‘. 

The revisions read as follows: 

§ 498.3 Scope and applicability. 

* * * * * 

(b) * * * 

(13) Except as provided at paragraph 

(d)(12) of this section for SNFs, NFs, 

HHAs, and hospice programs, the 

finding of noncompliance leading to the 

imposition of enforcement actions 

specified in § 488.406, § 488.820, or 

§ 488.1170 of this chapter, but not the 

determination as to which sanction or 

remedy was imposed. The scope of 

review on the imposition of a civil 

money penalty is specified in 

§ 488.438(e), § 488.845(h), or 

§ 488.1195(h) of this chapter. 

(14) * * * 

(i) The range of civil money penalty 

amounts that CMS could collect (for 

SNFs or NFs, the scope of review during 

a hearing on imposition of a civil money 

penalty is set forth in § 488.438(e) of 

this chapter and for HHAs and hospice 

programs, the scope of review during a 

hearing on the imposition of a civil 

money penalty is set forth in 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
36016 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Proposed Rules 

§§ 488.845(h) and 488.1195(h) of this 

chapter); or 

* * * * * 

§ 498.60 [Amended] 

■ 31. Section 498.60 is amended— 

■ a. In paragraph (c)(1) by removing the 

reference ‘‘§§ 488.438(e) and 

488.845(h)’’ and adding in its place the 

reference ‘‘§§ 488.438(e), 488.845(h), 

and 488.1195(g)’’. 

■ b. In paragraph (c)(2) by removing the 

phrase ‘‘or HHA’’ and adding in its 

place the phrase ‘‘HHA or hospice 

program’’. 

Dated: June 23, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–13763 Filed 6–28–21; 4:15 pm] 

BILLING CODE 4120–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2