[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Rules and Regulations]
[Pages 62240-62431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23993]
[[Page 62239]]
Vol. 86
Tuesday,
No. 214
November 9, 2021
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 409, 424, 483, et al.
Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment
System Rate Update; Home Health Value-Based Purchasing Model
Requirements and Model Expansion; Home Health and Other Quality
Reporting Program Requirements; Home Infusion Therapy Services
Requirements; Survey and Enforcement Requirements for Hospice Programs;
Medicare Provider Enrollment Requirements; and COVID-19 Reporting
Requirements for Long-Term Care Facilities; Final Rule
Federal Register / Vol. 86 , No. 214 / Tuesday, November 9, 2021 /
Rules and Regulations
[[Page 62240]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 424, 483, 484, 488, 489 and 498
[CMS-1747-F and CMS-5531-F]
RIN 0938-AU37 and 0938-AU32
Medicare and Medicaid Programs; CY 2022 Home Health Prospective
Payment System Rate Update; Home Health Value-Based Purchasing Model
Requirements and Model Expansion; Home Health and Other Quality
Reporting Program Requirements; Home Infusion Therapy Services
Requirements; Survey and Enforcement Requirements for Hospice Programs;
Medicare Provider Enrollment Requirements; and COVID-19 Reporting
Requirements for Long-Term Care Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This final rule updates 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 finalizes recalibration of the case-mix weights and updates
the functional impairment levels, and comorbidity adjustment subgroups
while maintaining the current low utilization payment adjustment (LUPA)
thresholds for CY 2022. Additionally, this rule finalizes a policy to
utilize the physical therapy LUPA add-on factor to establish the
occupational therapy add-on factor for the LUPA add-on payment amounts
and makes conforming regulations text changes to reflect that allowed
practitioners are able to establish and review the plan of care. It
also finalizes proposed changes to the Home Health Quality Reporting
Program (QRP) including finalizing proposed measure removals and
adoptions, public reporting, and modification of effective dates. It
also finalizes proposed modifications to the effective date for the
reporting of measures and certain standardized patient assessment data
in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care
Hospital (LTCH) QRP. In addition, this final rule codifies certain
Medicare provider and supplier enrollment policies. It also makes
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 updates
the home health conditions of participation regarding occupational
therapists assessment completion to implement provisions of the
Consolidated Appropriations Act, 2021 (CAA 2021). This final rule also
finalizes proposals to expand the Home Health Value-Based Purchasing
(HHVBP) Model and to end the original HHVBP Model one year early.
Lastly, it establishes survey and enforcement requirements for hospice
programs as set forth in the CAA 2021; and finalizes revisions to the
infection control requirements for long-term care (LTC) facilities
(Medicaid nursing facilities and Medicare skilled nursing facilities,
also collectively known as ``nursing homes'') that will extend the
mandatory COVID-19 reporting requirements beyond the current COVID-19
PHE until December 31, 2024.
DATES: These regulations are effective on January 1, 2022.
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 [email protected].
For general information about the Home Health Prospective Payment
System (HH PPS), send your inquiry via email to
[email protected].
For more information about the Home Health Value-Based Purchasing
Model, https://share.cms.gov/center/CCSQ/CSG/DIQS/LTC/LTCCOVIDReportingfinalrule/ please visit the HHVBP Model Expansion
webpage at https://innovation.cms.gov/innovation-models/home-health-value-based-purchasing-model.
For information about the Home Health Quality Reporting Program (HH
QRP), send your inquiry via email to [email protected].
For information about the home health conditions of participation,
contact Mary Rossi-Coajou at: [email protected], James
Cowher at [email protected], or Jeannine Cramer at
[email protected].
For provider and supplier enrollment process inquiries: Frank
Whelan, (410) 786-1302.
For information about the survey and enforcement requirements for
hospice programs, send your inquiry via email to
[email protected].
For information about the LTC facility requirements for
participation, contact Molly Anderson at: [email protected],
Diane Corning at [email protected], Kim Roche at
[email protected], or Alpha-Banu Wilson at
[email protected].
SUPPLEMENTARY INFORMATION:
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. Provisions for Payment Under the HH PPS
III. Home Health Value-Based Purchasing (HHVBP) Model
A. Expansion of the HHVBP Model Nationwide
B. 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. 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. Provisions
VII. Survey and Enforcement Requirements for Hospice Programs
A. Background
B. Provisions
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 Post-Acute 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. Revised Compliance Date for Certain Inpatient Rehabilitation
Facility (IRF) QRP Reporting Requirements
B. Revised Compliance Date for Certain Long-Term Care Hospital
(LTCH) QRP Reporting Requirements
X. COVID-19 Reporting Requirements for Long Term Care Facilities
A. Background
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B. Statutory Authority and Regulatory Background
C. Provisions of the Final Rule and Responses to Public Comments
XI. Collection of Information Requirements and Waiver of Proposed
Rulemaking
A. Statutory Requirement for Solicitation of Comments
B. Collection of Information Requirements
C. Submission of PRA-Related Comments
D. Waiver of Proposed Rulemaking
XII. 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
I. Executive Summary
A. Purpose
1. Home Health Prospective Payment System (HH PPS)
This final rule updates the payment rates for home health agencies
(HHAs) for CY 2022, as required under section 1895(b) of the Social
Security Act (the Act). This rule also finalizes recalibration of the
case-mix weights under sections 1895(b)(4)(A)(i) and 1895(b)(4)(B) of
the Act for 30-day periods of care in CY 2022 while maintaining the CY
2021 LUPA thresholds. This final rule updates 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 uses the
physical therapy (PT) add-on factor to establish the occupational
therapy (OT) LUPA add-on factor and finalizes conforming regulations
text changes at Sec. 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 rule, we expand the Home Health Value-Based Purchasing
(HHVBP) Model to all Medicare-certified HHAs in the 50 States,
Territories, and the District of Columbia beginning January 1, 2022
with CY 2022 as a pre-implementation year. We are finalizing that CY
2023 will be the first performance year and CY 2025 the first payment
year, based on HHA performance in CY 2023. We are also finalizing our
proposal to end the original HHVBP Model one 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 rule finalizes proposals under the HH QRP, including removal
of an Outcome and Assessment Information Set (OASIS)-based measure, the
Drug Education on All Medications Provided to Patient/Caregiver During
All Episodes of Care 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. This
rule also finalizes our 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 measure, and also finalizes our
proposal to begin public reporting of 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 rule finalizes proposed revisions to certain HH QRP
reporting requirements.
This rule also finalizes similar compliance dates for certain IRF
QRP and LTCH QRP requirements.
4. Changes to the Home Health Conditions of Participation
In this rule, we are finalizing our proposed changes to make
permanent selected regulatory blanket waivers related to home health
aide supervision that we extended to Medicare participating home health
agencies during the COVID-19 PHE. Blanket waivers to Medicare
requirements were issued to provide flexibilities to make sure
beneficiaries continue to have access to the health care they need
while reducing burden to HHAs. In addition, Division CC, section 115 of
CAA 2021 requires the Secretary of Health and Human Services (the
Secretary) 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.
Therefore, we are finalizing our proposed changes: (1) To the home
health aide supervision requirements; and (2) that allow occupational
therapists to complete the initial and comprehensive assessments for
patients.
5. Medicare Coverage of Home Infusion Therapy
This final rule updates 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 this final rule, we address a number of provisions regarding
Medicare provider and supplier enrollment. Most of these provisions
involve the finalization of the proposed codification of certain
subregulatory policies. These 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. We are also finalizing two
regulatory clarifications related to HHA changes of ownership and HHA
capitalization requirements.
7. Survey and Enforcement Requirements for Hospice Programs
In this final rule, we are finalizing changes 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. We continue 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.
8. COVID-19 Reporting Requirements for Long Term Care Facilities
This final rule revises the infection control requirements that LTC
facilities must meet to participate in the Medicare and Medicaid
programs. By doing so, LTC facilities will be required to continue the
COVID-19 reporting requirements published in the Additional Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency interim final rule with comment period, published on May 8,
2020 (85 FR 27550) and the interim final rule, COVID-19 Vaccine
Requirements for Long-Term Care (LTC) Facilities and Intermediate Care
Facilities for Individuals With
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Intellectual Disabilities (ICFs-IID) Residents, Clients, published on
May 13, 2021 (86 FR 26306). LTC facilities will be required to continue
to report on a weekly basis to the Centers for Disease Control and
Prevention (CDC) National Healthcare Safety Network (NHSN), suspected
and confirmed COVID-19 infections, total deaths and COVID-19 deaths,
personal protective equipment (PPE) and hand hygiene supplies,
ventilator capacity and supplies, resident beds and census, access to
COVID-19 testing, staffing shortages, therapeutics administered to
residents for the treatment of COVID-19 requirements until December 31,
2024, with the possibility of reduced frequency of reporting and
modified or limited data elements that are required in the future at
the discretion of the Secretary. They will also be required to report
the COVID-19 vaccination status of residents and staff, including total
numbers of residents and staff, numbers of residents and staff
vaccinated, numbers of each dose of COVID-19 vaccine received, and
COVID-19 vaccination adverse events.
B. Summary of the Provisions of This Rule
1. Home Health Prospective Payment System (HH PPS)
In the CY 2022 proposed rule (86 FR 35874) we included discussions
of preliminary Patient-Driven Groupings Model (PDGM) monitoring data
and analyses on home health utilization; LUPAs; the distribution of the
case-mix methodology as determined by clinical groupings, admission
source and timing, functional status, and comorbidities; and therapy
visits. Additionally, we provided preliminary analysis on HHA
expenditures as reported on 2019 cost reports to estimate the
difference between Medicare payments and HHAs' costs. We also provided
a description and solicited comments on a potential repricing
methodology for determining the difference between assumed versus
actual behavior change on estimated aggregate expenditures for home
health payments. In section II.B.1. and 2. of this final rule, we
provide a summary of comments on these topics.
In section II.B.3. of this rule, we are finalizing the
recalibration of the PDGM case-mix weights, functional levels, and
comorbidity adjustment subgroups while maintaining the CY 2021 LUPA
thresholds for CY 2022.
In section II.B.4. of this rule, we update the home health wage
index, and we also update the CY 2022 national, standardized 30-day
period payment rates and the CY 2022 national per-visit payment amounts
by the home health payment update percentage. The home health payment
update percentage for CY 2022 is 2.6 percent. Additionally, this rule
finalizes the FDL ratio at 0.40 for CY 2022, in order to ensure that
aggregate outlier payments do not exceed 2.5 percent of the total
aggregate payments, as required by section 1895(b)(5)(A) of the Act.
In section II.B.4.c.(5). of this final rule, we finalize changes to
utilize the physical therapy (PT) LUPA add-on factor to establish the
OT add-on factor for the LUPA add-on payment amounts with respect to
the initial patient assessments newly permitted under Division CC,
section 115 of CAA 2021 that revised Sec. 484.55(a)(2) and (b)(3).
Section II.B.6. of this final rule finalizes conforming regulations
text changes at Sec. 409.43 to reflect new statutory provisions that
allow practitioners in addition to physicians to establish and
periodically review the home health plan of care. These changes are 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 final rule, we are finalizing our
proposal to expand the HHVBP Model to all Medicare-certified HHAs in
the 50 States, territories, and District of Columbia beginning January
1, 2022. However, we are designating CY 2022 as a pre-implementation
year in response to a number of comments we received. CY 2023 will be
the first performance year and CY 2025 the first payment year, with a
maximum payment adjustment, upward or downward, of 5 percent. We are
finalizing 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,
2022, would be required to participate and would be eligible to receive
an annual Total Performance Score based on their CY 2023 performance.
We are finalizing 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, Home Health Consumer Assessment
of Healthcare Providers and Systems (HHCAHPS) survey-based, and claims-
based measures submission in the applicable measure set beginning CY
2022 and subsequent years. We are also finalizing our 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 final rule, we are finalizing our
proposal to end the original HHVBP Model one year early. We are
finalizing that we will 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 are finalizing that we will 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 final rule, we are finalizing the proposed
updates to the HH QRP including: The removal of one OASIS-based
measure, replacement of two claims-based measures with one claims-based
quality measure; public reporting of two measures; revising the
compliance date for certain reporting requirements for certain HH QRP
reporting requirements; and summarizing comments received on our
requests for information regarding digital quality measures and health
equity.
4. Changes to the Home Health Conditions of Participation
In this section IV.D. of this rule, we finalize our proposal to
make permanent selected regulatory blanket waivers related to home
health aide supervision that we extended to Medicare-participating home
health agencies during the COVID-19 PHE. In addition, we are revising
our regulations to reflect Division CC, section 115 of CAA 2021. This
provision 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 finalizing proposed changes to the home health aide
supervision requirements at Sec. 484.80(h)(1) and (2) and conforming
regulation text changes at Sec. 484.55(a)(2) and (b)(3), respectively,
[[Page 62243]]
to allow occupational therapists to complete the initial and
comprehensive assessments for patients in accordance with changes in
the law.
We are also making a technical correction at Sec. 484.50(d)(5).
5. Medicare Coverage of Home Infusion Therapy
In section V. of this final 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).
Additionally, we discuss the home infusion therapy services payment
adjustments including finalizing the proposal to update the geographic
adjustment factors (GAFs) used for wage adjustment and finalizing the
proposal to maintain the percentages finalized for the initial and
subsequent visit policy. In this section we also 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 final rule, we addressed 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 sub-regulatory policies. These are addressed in
section VI.B. of this final rule and include, for example, policies
related to: (1) The effective date of billing privileges for certain
provider and supplier types and the effective date of certain provider
enrollment transactions; and (2) the deactivation of a provider's or
supplier's billing privileges.
In addition, we finalized in section VI.C. of this final 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 final rule, there are a number of
provisions related to Division CC, section 407 of CAA 2021. These
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 CMS-approved hospice
programs to begin use of the Form CMS-2567. Additionally, we are
finalizing our proposed provisions to establish a hospice program
complaint hotline. Lastly, the finalized provisions create 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. The Special Focus Program will be considered in future
rulemaking.
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. When a CMS-approved AO program accredits a
provider, CMS ``deems'' the provider to have complied with applicable
Medicare conditions or requirements. The CAA 2021 provisions expanding
requirements for AOs will apply to AOs with CMS-approved accreditation
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 described and solicited comments on all aspects of the proposed
survey and enforcement provisions for hospice programs.
8. Inpatient Rehabilitation Facility (IRF) Quality Reporting Program
In section IX.A. of this final rule, we are finalizing our proposal
to modify the compliance date for certain reporting requirements in the
IRF QRP.
9. Long Term Care Hospital (LTCH) Quality Reporting Program
In section IX.B. of this final rule, we are finalizing our proposal
to modify the compliance date for certain reporting requirements in the
LTCH QRP.
10. COVID-19 Reporting Requirements for Long-Term Care (LTC) Facilities
In section X.C of this final rule, we finalize our COVID-19
reporting requirements with the following modifications:
Reporting frequency is modified to no more than weekly,
and may be reduced, at the discretion of the Secretary;
The possibility of modified or limited data elements that
are required in the future, contingent on the state of the pandemic and
at the discretion of the Secretary.
The addition of a sunset date of December 31, 2024, for
all reporting requirements, with the exclusion of the reporting
requirements at Sec. [thinsp]483.80(g)(1)(viii).
C. Summary of Costs, Transfers, and Benefits
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[GRAPHIC] [TIFF OMITTED] TR09NO21.000
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, 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, 41214).
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
[[Page 62245]]
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 Sec. 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, section 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,
speech-language 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-guidanceguidancetransmittals2020-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 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
[[Page 62246]]
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, 70305).
[GRAPHIC] [TIFF OMITTED] TR09NO21.075
B. Provisions of the Final Rule
1. PDGM Monitoring
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
2022 HH PPS proposed rule (86 FR 35880), we provided preliminary data
analyses on the PDGM including: Overall home health utilization,
clinical groupings and comorbidities, admission source and timing,
functional impairment levels, and therapy visits. We also provided data
analysis on the 2019 HHA Medicare cost reports. We solicited comments
on the preliminary PDGM data and cost analyses, along with other
factors CMS should be monitoring. These comments and our responses are
summarized in this section of the rule.
Comment: Many commenters viewed the overall decrease in utilization
as more likely related to the COVID-19 PHE, rather than the
implementation of the PDGM. One industry association stated that the
COVID-19 PHE brought extensive changes in patient mix, home health
patient census, significant practice changes and changes in admission
source referrals. Commenters also stated because of the COVID-19 PHE,
patients were often unwilling to allow home health clinicians into
their
[[Page 62247]]
homes to receive needed care. Commenters also indicated that half of
HHAs provided services to actively infected COVID-19 patients. We
received several comments regarding the increase of LUPAs in CY 2020.
Commenters remarked that the increase of LUPAs is more attributable to
pandemic-related factors rather than HHAs taking advantage of the PDGM.
Commenters also stated that the use of telehealth for the provision of
home health visits contributed to the increase in LUPAs in CY 2020
because of safety concerns and patient refusal to allow for in-person
visits. Other commenters stated because telehealth services are not
reported as home health visits, utilization of home health services is
not fully captured. Additionally, several commenters recommended that
CMS examine CY 2020 data at a more granular level due to the COVID-19
PHE, including, but not limited to, geographical differences and
seasonal trends.
Response: CMS appreciates all of the comments received regarding CY
2020 utilization trends and the impact of the COVID-19 PHE on the
provision of home health services. We acknowledge commenter statements
and concerns as to how the COVID-19 PHE affected the types of home
health patients served and how HHAs had to adjust care practices in
response. We also understand that the COVID-19 PHE has presented unique
challenges for all providers who have had to develop and institute new
protocols and processes to ensure the health and safety of home health
staff and beneficiaries. CMS instituted maximum flexibilities and
implemented waivers to assist providers in navigating the COVID-19 PHE
and to safeguard the continued provision of Medicare home health
services.\1\
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\1\ Coronavirus waivers & flexibilities. https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
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In the CY 2021 HH PPS final rule (85 FR 70298), CMS finalized
changes to Sec. 409.43(a) as implemented in the March, 2020 COVID-19
interim final rule with comment (IFC) (85 FR 19230), to allow the use
of telecommunications technology more broadly, even outside of the
COVID-19 PHE. If HHAs use telecommunications technology in the
provision of home health care, the regulations state that the plan of
care must include any provision of remote patient monitoring or other
services furnished via a telecommunications system and that these
services cannot substitute for a home visit ordered as part of the plan
of care and cannot be considered a home visit for the purposes of
patient eligibility or payment, in accordance with section
1895(e)(1)(A) of the Act. Such changes were made to provide flexibility
in the provision of care during the COVID-19 PHE and beyond as we
recognize telecommunication services, at times, may be in the best
interest of the patient and support the overall care of beneficiaries.
However, since the law does not consider services furnished via a
telecommunications system a home visit, these encounters, while
allowed, are not included in utilization analysis.
We also understand the interest in monitoring the impact of the
COVID-19 PHE on home health services. While we continue to conduct
analyses on home health utilization and other metrics, including the
effects of COVID-19, we note that the PHE is ongoing and as such,
patterns and trends may change over time. We will continue to examine
the effects of the ongoing COVID-19 PHE on home health utilization and
will determine when and how best to provide this information. We note
that CMS does publish COVID-19 data and statistics, which provides
information on how the COVID-19 PHE is affecting the Medicare
population and aims to better inform individual and public policy
healthcare decisions to address the impact of COVID-19.\2\
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\2\ Preliminary Medicare COVID-19 Data Snapshot. https://www.cms.gov/research-statistics-data-systems/preliminary-medicare-covid-19-data-snapshot.
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Comment: Several commenters requested additional detailed analyses
of the impact of the PDGM on home health utilization. Some examples of
suggested additional analyses included demographic data, social
determinants of health, Program for Evaluating Payment Patterns
Electronic Report (PEPPER reports), and HHA provider types, such as
profit versus non-profit. A commenter recommended that CMS should
supplement its analysis of utilization data with additional data and
monitoring tools, such as survey data. Another commenter supports CMS'
plans to assess the relationship of the OASIS GG items to resource use
and their correlation to the current OASIS M1800-1860 items that
address functional status. We received several comments stating that
the level of data provided in the proposed rule did not reflect whether
the home health services furnished were appropriate. Commenters also
suggested that CMS examine patient outcomes and patient experiences in
future rulemaking. Other commenters raised concerns about HHA admission
practices. Commenters expressed concern that some HHAs exclude eligible
beneficiaries with longer-term, chronic conditions, prematurely
discharge patients, ``cherry-pick'' patients to admit to home health,
and decrease necessary home health aide services. Several commenters
requested that CMS continue to closely review and monitor therapy
utilization data under the PDGM to evaluate for unintended
consequences, and if, appropriate implement safeguards as needed.
Specifically, commenters stated that the removal of therapy thresholds
for payment have resulted in decreases in therapy utilization,
termination of therapy staff, and increased use of algorithms, rather
than clinical judgment, to determine the appropriate number of therapy
visits.
Response: We thank commenters for the additional suggestions for
more detailed analyses on home health utilization and other relevant
trends and will consider such suggestions for future analyses. We
appreciate the concerns by commenters regarding potential aberrant
practices and quality of care issues. As we continue to analyze home
health utilization, we will monitor for any emerging trends that may
warrant any program integrity actions.
Regarding the concerns related to the removal of therapy
thresholds, beginning in CY 2020, section 1895(b)(4)(B)(ii) of the Act,
as added by section 51001 of the Bipartisan Budget Act of 2018 (BBA
2018) eliminated the use of therapy thresholds in calculating payments
for CY 2020 and subsequent years. However, as with analysis of overall
home health utilization, we will continue to monitor the provision of
therapy visits, including by subspecialty. We remind commenters that
all home health services, including therapy, must be provided in
accordance with the Conditions of Participation at 42 CFR 484.60.
Specifically, the individualized plan of care must specify the care and
services necessary to meet the patient-specific needs as identified in
the comprehensive assessment, including identification of the
responsible discipline(s), and the measurable outcomes that the HHA
anticipates will occur as a result of implementing and coordinating the
plan of care. The individualized plan of care must also specify the
patient and caregiver education and training. Services must be
furnished in accordance with accepted standards of practice.
Comment: We received several comments regarding our analysis on the
CY 2019 Medicare home health cost reports. Specifically, commenters
expressed concerns over the accuracy of
[[Page 62248]]
cost report data. Commenters stated that the home health agency cost
report data may not adequately reflect the home health industries'
costs as providers vary in complexity, sophistication, size and
resources.
Response: We appreciate the commenters' feedback on the CY 2019
cost report analysis provided in the proposed rule. We recognize that
with the COVID-19 PHE, the CY 2019 data on the Medicare cost reports
may not reflect the most recent changes such as increased
telecommunications technology costs, increased PPE costs, and hazard
pay. As we stated in the CY 2022 HH PPS proposed rule (86 FR 35884),
when the CY 2020 cost reports become available, we will update the
estimated 30-day period of care costs in CY 2020 in future rulemaking.
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
In the CY 2019 HH PPS final rule with comment period (83 FR 56455),
we finalized the use of three behavior assumptions in order to
calculate a 30-day budget-neutral payment amount for CY 2020 as
required by section 1895(b)(3)(A)(iv) of the Act. These included the
clinical coding, the comorbidity, and the LUPA behavior assumptions. 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, assuming
that these behaviors would happen half as frequently during the first
year of implementation of the PDGM and 30-day unit of payment. 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 with comment
period (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. In the CY 2022 proposed rule (86 FR 35889), we solicited
comments on a possible methodology where we would use actual CY 2020
30-day period claims data to simulate 60-day episodes to determine what
CY 2020 payments would have been under the 153-group case-mix system
and 60-day unit of payment. We also solicited comments on any potential
alternative methods for determining the difference between assumed and
actual behavior changes on estimated aggregate expenditures. We
received comments on the methodology described in the proposed rule,
comments regarding potential alternative methods, and comments on the
previously finalized behavior assumptions which are summarized in this
section of the rule.
Comment: We received several comments stating that an independent
analysis of the actual versus assumed behavior changes show that CMS'
assumptions on two of the three previously finalized behavior
assumptions were inaccurate. These commenters stated that CMS
overestimated the clinical group assumption and the LUPA assumption.
These commenters stated that the magnitude of coding the highest paying
clinical diagnosis was overstated and the actual change in coding
practices did not manifest as CMS assumed. Commenters also stated that
there was a significant increase in the frequency of LUPA periods of
care, indicating that the LUPA assumption also was overestimated. That
is, commenters stated that HHAs did not make 1-2 extra visits to meet
or exceed the LUPA threshold to receive a full, case-mix adjusted 30-
day period payment. Commenters recommended that we remove these
behavior assumptions and the -4.36 percent payment adjustment for rate
setting in CY 2022. Other comments stated that not only should the -
4.36 percent adjustment be removed, but that we should further increase
the 30-day payment in CY 2022.
A few commenters stated CMS does not have the authority to
institute budget neutrality adjustments beyond those related to
behavior changes. In addition, a few commenters stated we must utilize
a PDGM budget neutrality methodology that is solely focused on assumed
behavior changes that were incorporated into the original 2020 rate
setting.
Many commenters noted, as projected, the reported comorbidity
levels have increased. Some commenters state this change may be because
HHAs are now comprehensively recording these secondary diagnoses on
home health claims, thereby more accurately reflecting patient acuity.
However, other commenters disagreed and believe there is a change in
aggregate patient acuity due to the COVID-19 PHE. Several commenters
stated that there have been noted increases in the functional
impairment level. Many stated that an increase of patients into the
high functional impairment category and a decrease in the low
functional impairment category could be a direct result of the COVID-19
PHE, because HHAs had to accept higher acuity and more functionally
impaired patients while elective surgeries were canceled and decreased
the utilization in patients with lower functional impairment scores.
The majority of commenters were supportive of foregoing any payment
adjustment in CY 2022 based on the difference between assumed versus
actual behavior change.
Response: We appreciate the commenters feedback and would like to
remind commenters that section 1895(b)(3)(a)(iv) of the Act required
CMS to make behavioral assumptions when calculating the budget-neutral
30-day payment rate. Section 1895(b)(3)(D) of the Act also requires CMS
to annually determine the impact of differences between assumed
behavior changes and actual behavior changes on estimated aggregate
expenditures beginning with CY 2020 and ending with CY 2026. Therefore,
we cannot simply remove a behavior change assumption; rather, we are
required by law to annually determine the effects of behavior change on
estimated aggregate expenditures. Furthermore, we stated in the CY 2019
HH PPS final rule with comment period (53 FR 56455), the CY 2020 HH PPS
final rule with comment period (84 FR 60513), and the CY 2022 HH PPS
proposed rule (86 FR 35890), 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 amount for CY 2020 was
determined.
The law gives CMS the discretion to make temporary and permanent
payment adjustments at a time and in a manner determined, by the
Secretary, to be appropriate. As such, we did not propose any
adjustment to the national, standardized 30-day payment rate in the CY
2022 HH PPS proposed rule based on any behavior assumptions. The law
requires that we make any temporary and permanent payment adjustment
based on the difference between assumed versus actual behavior change
on estimated aggregate expenditures through notice and comment
rulemaking.
Given some of the comments stating that CMS overestimated the
behavior change, we wish to remind commenters that the CYs 2020 and
2021 LDS files
[[Page 62249]]
included two separate datasets; one uses claims with a ``full''
behavior assumption applied, using the initial proposed -8.389 percent
adjustment, and the other uses claims with a ``no'' behavior assumption
applied (no adjustment for changes in behavior). As stated previously
in the CY 2020 HH PPS final rule with comment period (84 FR 60512), CMS
applied the three behavioral assumptions to only half of the 30-day
periods of care, randomly selected. The -4.36 percent behavior
adjustment is not included in the CYs 2020 and 2021 LDS files given the
30-day periods to which the assumptions were applied were done so
randomly. Therefore, any independent analysis conducted would need to
include application of the behavior assumptions to only half of the 30-
day periods in the LDS files.
Comment: The majority of commenters disagreed with the methodology
set out in the proposed rule. Their concerns related to: The exclusions
we applied to the data when simulating 60-day episodes claims from 30-
day periods; the impact of the COVID-19 PHE; the lack of comparability
between case-mix models (for example, the assertion that a case-mix of
1.0 is not the same across two systems); and the removal of payment
incentives for therapy visits leading to a decline in therapy services
furnished in CY 2020. Many commenters offered an alternative approach
to compare CY 2018 60-day episodes converted to 30-day periods used for
CY 2020 rate setting to actual CY 2020 30-day periods. Commenters
stated such approach would more accurately determine the differences
between assumed versus actual behavior changes on estimated aggregate
expenditures, would be less biased, would eliminate the need to model
other changes that occurred due to the implementation of the PDGM, and
would avoid the impact of the COVID-19 PHE on therapy utilization. A
few commenters also recommended to incorporate some analysis of
evaluating ``real'' and ``nominal'' changes in the average case-mix
weight.
However, MedPAC supported the method presented in the proposed rule
for computing the budget-neutral amount stating the method was
reasonable and would satisfy the requirement to reconcile payments
based on the differences between assumed versus actual behavior change
on estimated aggregate expenditures, as required by section
1895(a)(3)(D) of the Act.
Response: We appreciate the commenters' comprehensive review of the
methodology described in the CY 2022 HH PPS proposed rule. We will
consider all alternative approaches as we continue to develop and
refine a methodology for annually determining the difference between
assumed versus actual behavior changes on estimated aggregate
expenditures. As stated previously, the methodology and any associated
payment adjustment based on the difference between assumed versus
actual behavior change on estimated aggregate expenditures will be made
through future notice and comment rulemaking.
3. CY 2022 PDGM LUPA Thresholds and PDGM Case-Mix Weights
a. 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 with comment period (83 FR 56492), we finalized
our policy 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 is 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 final rule. For example, if the LUPA
visit threshold is four, and a 30-day period of care has four or more
visits, it is paid the full 30-day period payment amount; if the period
of care has three or less visits, payment is made using the per-visit
payment amounts.
In the CY 2019 HH PPS final rule with comment period (83 FR 56492),
we finalized our policy that the LUPA thresholds for each PDGM payment
group would be reevaluated every year based on the most current
utilization data available at the time of rulemaking. However, CY 2020
was the first year of the new case-mix adjustment methodology and 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, we proposed to update the case-mix weights for CY 2022 using
CY 2020 data as 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
COVID-19 PHE would have impacted utilization within all case-mix groups
similarly. Therefore, the impact of any reduction in resource use
caused by the COVID-19 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 COVID-19 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 had
proposed to set the LUPA thresholds 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 short-term variability in the LUPA
thresholds due to the COVID-19 PHE, we proposed 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
was 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 COVID-19 PHE. The public comments on
our proposal to maintain the CY 2021 LUPA thresholds for CY 2022
payment purposes and our responses are summarized in this section of
the rule.
[[Page 62250]]
Comment: Some commenters expressed their support for the policy to
maintain the CY 2020 LUPA thresholds for CY 2022 in order to mitigate
potential fluctuations in the thresholds caused by changing visit
patterns in CY 2020 potentially due to the COVID-19 PHE. One commenter
recommended that CMS allow telehealth visits to be counted toward
meeting LUPA thresholds. This commenter stated that in situations where
virtual care visits can be equally as efficacious as an in-person
meeting, and CMS should allow these visits to count within this payment
framework.
Response: We thank the commenters for their support. As noted
previously, the goal of maintaining the LUPA thresholds for CY 2022 is
to mitigate any potential fluctuations in the thresholds resulting from
any changes in visit patterns resulting from the COVID-19 PHE. While we
understand that there are ways in which technology can be further
utilized to improve patient care, better leverage advanced practice
clinicians, and improve outcomes while potentially making the provision
of home health care more efficient, we remind stakeholders that under
current law, services furnished via a telecommunications system cannot
be considered a home health visit for purposes of eligibility or
payment. Section 1895(e)(1)(A) of the Act prohibits payment for
services furnished via a telecommunications system if such services
substitute for in-person home health services ordered as part of a plan
of care.
Final Decision: We are finalizing the proposal to maintain the LUPA
thresholds for CY 2022. The LUPA thresholds for CY 2022 are located on
the HHA Center webpage.\3\
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\3\ Home Health Agency Center webpage. https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
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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 \1/3\ of home health periods from each of the
clinical groups fall within each level. 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 proposed 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 Home Health
Groupings Model (HHGM) technical report from December 2016 \4\ provide
a more detailed explanation as to the construction of these functional
impairment levels using the OASIS items. We proposed 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 functional impairment levels by clinical group for CY 2022 are
listed in Tables 2 and 3, respectively.
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\4\ Overview of the Home Health Groupings Model Technical
Report. November 2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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BILLING CODE P
[[Page 62251]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.001
[[Page 62252]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.002
BILLING CODE C
[[Page 62253]]
The following is a summary of the comments received and our
responses to comments on the proposal to update the functional points
and the functional impairment levels by clinical group.
Comment: MedPAC was supportive of the proposal to update the
functional points and functional impairment levels for CY 2022 and
recommended that CMS to continue to update the functional categories in
this manner in future payment years. MedPAC stated that the re-
weighting CMS proposed for CY 2022 would reset the payment categories
based on 2020 data, so that periods will again be evenly distributed
across the three functional payment categories. MedPAC believes that
maintaining this distribution helps to ensure the accuracy of Medicare
payments.
Response: We thank the Commission for its support.
Final Decision: We are finalizing the proposal to update the
functional points and functional impairment levels for CY 2022.
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 diagnosis
subgroups 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 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 so that payments align with the actual costs of
providing care. For CY 2022, we proposed 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 proposed to update the comorbidity subgroups to
include 20 low comorbidity adjustment subgroups and 85 high comorbidity
adjustment interaction subgroups. To generate the final comorbidity
subgroups, we used CY 2020 home health claims data with linked OASIS
data (as of July 12, 2021). The tables later in this section have been
revised to reflect the results using the updated data. The final
comorbidity subgroups include 20 low comorbidity adjustment subgroups
as identified in Table 4 and 87 high comorbidity subgroups as
identified in Table 5.
BILLING CODE P
[GRAPHIC] [TIFF OMITTED] TR09NO21.003
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[GRAPHIC] [TIFF OMITTED] TR09NO21.004
[[Page 62255]]
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In this section of the rule is a summary of the comments received
and our response to those comments on the proposed updates to the low
comorbidity adjustment subgroups and the high comorbidity adjustment
subgroups for CY 2022.
Comment: A commenter requested that CMS reassign diseases and
disorders, as well as specific ICD-10 CM diagnosis codes, to different
clinical groups or comorbidity subgroups to align with codes
representing either similar conditions or similar clinical
manifestations. The commenter requested the following reassignments:
(1) Reassign dementia codes currently listed in the Behavioral
Health clinical group to the Neuro Rehabilitation clinical group,
due to the clinical similarities of Alzheimer's Disease and
dementia, and to mirror the current classification of dementia
within the neurological comorbidity subgroup
(2) Add musculoskeletal pain, M25.5XX codes to the
Musculoskeletal Rehabilitation (MS-Rehab) clinical group when listed
as a primary diagnosis, as 14 of 17 M25.5XX codes are included in
the Musculoskeletal 3 comorbidity subgroup;
(3) Add the ``specified by organism'' sepsis codes A40.0 through
A40.9 and A41.01 through A41.89 to the Infectious 1 comorbidity
subgroup to align with current coding practices including A41.9
sepsis unspecified;
(4) Assign leukemia in relapse diagnosis subgroup codes, C92.4X,
C92.5X, C92.6X, C92.AX to the Neoplasm 22 comorbidity subgroup,
consistent with similar leukemia codes included in this comorbidity
subgroup;
(5) Reassign the diagnosis subgroup diabetes with mononeuropathy
codes, EXX.41, and the diagnosis subgroup diabetes with autonomic
(poly)neuropathy, EXX.43, codes to the Neurological 10 comorbidity
subgroup, as neuropathy is a neurological condition and the
Neurological 10 comorbidity subgroup already contains diabetic
polyneuropathy codes;
(6) Review the Neurological 11 comorbidity subgroup for a
potential error since almost all the codes are related to vision
issues except for the neuropathy diagnosis subgroup G62 codes. In
addition, the commenter noted other types of hereditary and
idiopathic neuropathy diagnosis subgroup G60 codes and inflammatory
neuropathy diagnosis subgroup G61 codes are not assigned to a
comorbidity subgroup when listed as a secondary diagnosis. The
commenter requested reassigning the neuropathy diagnosis subgroup
codes G60, G61, and G62 to the Neurological 10 comorbidity subgroup,
which currently includes diabetic neuropathy;
(7) Assign rheumatic tricuspid valve disease diagnosis codes I08
to the Heart 9 comorbidity subgroup to align with other nonrheumatic
valve disorders.
Response: We appreciate the commenter's review of these codes and
suggested reassignments. As we stated in the CY 2020 final rule with
comment period (84 FR 60510), and as described in the technical report
``Overview of the Home Health Groupings Model'',\5\ the home health-
specific comorbidity list is based on the principles of patient
assessment by body systems and their associated diseases, conditions,
and injuries. We used this process to develop categories of conditions
that identify clinically relevant relationships associated with
increased resource use. We understand the magnitude of clinical
conditions and comorbidities, and the interactions that exist between
them, in the Medicare home health population; however, we remind
commenters that only those subgroups of diagnoses that represent more
than 0.1 percent of periods of care and that have at least as high as
the median resource use will receive a low comorbidity adjustment. We
describe this method for determining statistical significance in the CY
2020 final rule with comment period (84 FR 60510). This is based on the
knowledge that the average number of comorbidities in the aggregate
becomes the standard within that population for the purpose of payment.
However, because we still expect HHAs to report all secondary diagnoses
that affect care planning, there will be comorbidity subgroups included
in the home health-specific list that don't meet the criteria to
receive an adjustment.
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\5\ Overview of the Home Health Groupings Model. November 18,
2016. https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
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We reviewed each of the requested coding changes to determine if
the reassignment to a certain clinical group or comorbidity subgroup
was warranted.
1. Request for Dementia Codes To Be Reassigned From the Behavioral
Health Clinical Group to the Neuro Rehabilitation Clinical Group
We determined there are only two dementia codes listed in the
Behavioral Health clinical group with a Neurological 3 comorbidity
subgroup; both of which are unspecified dementia codes. Because the
commenter stated that reclassifying the dementia codes to a different
clinical group would align with the current comorbidity subgroup
Neurological 3, we expanded our review to include all ICD-10 CM
diagnosis codes in the Neurological 3 comorbidity subgroup. Table 6
lists these codes, their
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description, their current assigned clinical group, and current
assigned comorbidity subgroup.
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Our clinical advisors determined that because the two dementia
codes (F03.90 and F03.91) listed in the Behavioral Health clinical
group are unspecified and the etiology is unknown, they are clinically
appropriate to be in the Behavioral Health clinical group and would not
warrant a change in clinical group assignment. Upon review of the
comorbidity subgroup codes in Table 6, we determined that these codes
are more appropriate in a behavioral health comorbidity subgroup.
Additionally, assigning these codes to the Behavioral 4 comorbidity
subgroup does not result in a change in the comorbidity adjustment for
these codes.
2. Request for Musculoskeletal Pain Diagnosis Subgroup, M25.5X Codes To
Be Reassigned to Musculoskeletal Rehab Clinical Group
We reviewed the ICD-10 CM diagnoses codes M25.5XX indicating
musculoskeletal pain. Table 7 lists these codes, their description,
their current assigned clinical group and current assigned comorbidity
subgroup.
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Our clinical advisors reviewed the ICD-10 CM diagnoses codes
M25.5XX for musculoskeletal pain and have determined that these codes
lack the specificity to clearly support a rationale for skilled
services. In the CY 2019 HH
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PPS final rule with comment period (83 FR 56473), we stated that many
of the codes that indicate pain or contractures as the primary
diagnosis, for example M54.5 (low back pain) or M62.422 (contracture of
muscle, right hand), although site specific, do not indicate the cause
of the pain or contracture. We stated that we would expect a more
definitive diagnosis indicating the cause of the pain or contracture,
as the reason for the skilled care, in order to appropriately group the
home health period. While we believe that codes that describe signs and
symptoms (as opposed to diagnoses) are not appropriate as principal
diagnosis codes for grouping home health periods into clinical groups,
we recognize that pain can significantly impact the patient's recovery
and plan of care. Therefore, when musculoskeletal pain with a specific
location is indicated as a secondary diagnosis, we believe these codes
are appropriate to remain in the Musculoskeletal 3 comorbidity
subgroup. We disagree with the comment that the ICD-10 CM diagnoses
codes M25.5XX should be reassigned to the MS-Rehab clinical group.
3. Request for Sepsis, Specified by Organism Codes To Be Assigned to
the Infectious 1 Comorbidity Subgroup
We reviewed sepsis, specified by organism, codes A40.0 through
A40.9 and A41.01 through A41.89. Table 8 lists these codes, their
description, their current assigned clinical group, and current
assigned comorbidity subgroup.
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Our clinical advisors reviewed the ICD-10-CM codes A40.0 through
A40.9 and A41.01 through A41.89 and concur that clinically these codes
are appropriate for inclusion in the Infectious 1 comorbidity subgroup
when listed as a secondary diagnosis. We remind readers that ICD-10 CM
codes A40.0 through A40.9 and A41.01 through A41.89 require the
etiology code to be coded as primary, when applicable. When we
reassigned the codes listed in Table 8 to Infectious 1, there was no
change to the comorbidity adjustment for these codes (for example, no
change in payment).
[[Page 62262]]
5. Request for Leukemia in Relapse Codes To Be Reassigned to the
Neoplasm 22 Comorbidity Subgroup
We reviewed the ICD-10 CM codes indicating leukemia or
histiocytosis with no comorbidity subgroup when listed as a secondary
diagnosis. Table 9 lists these codes, their description, their current
assigned clinical group, and current assigned comorbidity subgroup.
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Our clinical advisors reviewed the leukemia and histiocytosis codes
listed in Table 9 and concur that these codes are appropriate for
inclusion in the Neoplasm 22 comorbidity subgroup when listed as a
secondary diagnosis code. When we reassigned the codes listed in Table
9 to Neoplasm 22, there was no change to the comorbidity adjustment for
these codes (for example, no change in payment).
5. Request for Subgroup of Diabetes With Mononeuropathy and Autonomic
(Poly) Neuropathy Be Reassigned to the Neurological 10 Comorbidity
Subgroup
We reviewed the ICD-10 CM diagnosis codes, diabetes with
mononeuropathy, EXX.41, and diabetes with autonomic (poly)neuropathy,
EXX.43. Table 10 lists these codes, their description, their current
assigned clinical group, and current assigned comorbidity subgroup.
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Our clinical advisors first reviewed all of the current ICD-10 CM
diagnoses currently listed in the Neurological 10 comorbidity subgroup.
We determined that all of the codes listed in the Neurological 10
comorbidity subgroup are specific to diabetic unspecified neuropathy or
diabetic polyneuropathy. The ICD-10 CM diagnosis codes EXX.41, diabetes
with mononeuropathy, are different from diabetes with unspecified
neuropathy or diabetic polyneuropathy in terms of clinical effects on
the body system as a whole. Therefore, we disagree that the ICD-10 CM
diagnosis codes EXX.41 should be reassigned to the Neurological 10
comorbidity subgroup. However, our clinical advisors agree that ICD-10
CM diagnosis subgroup EXX.43, diabetes with autonomic (poly)neuropathy,
should be reassigned to the Neurological 10 comorbidity subgroup. The
Endocrine 2 and Endocrine 3 comorbidity subgroups currently receive no
comorbidity adjustment; whereas the Neurological 10 comorbidity
subgroup currently receives a low comorbidity adjustment. Reassignment
of the ICD-10 CM diagnosis subgroup EXX.43, diabetes with autonomic
(poly)neuropathy, to Neurological 10 results in these codes receiving a
low comorbidity adjustment when listed as a secondary diagnosis.
6. Request for Neuropathy Diagnosis Subgroup G60, G61, and G62 Codes To
Be Reassigned to the Neurological 10 Comorbidity Subgroup
We reviewed the Neurological 11 comorbidity subgroup and concur
with the commenter that almost all of the ICD-10 CM diagnosis codes
listed are primarily related to eye diseases and disorders (for
example, retinopathy and macular degeneration). As the commenter also
noted that there are other types of hereditary, idiopathic, and
inflammatory neuropathies with no neurological comorbidity subgroup
assigned, we reviewed the diagnosis subgroup G codes indicating a
specified neuropathy (mono or poly) or unspecified polyneuropathy.
Table 11 lists these codes, their description, their current assigned
clinical group, and comorbidity subgroup.
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We determined that all of the codes listed in the Neurological 10
comorbidity subgroup are specific to diabetic unspecified neuropathy or
diabetic polyneuropathy and therefore disagree that the neuropathy
diagnosis subgroup G60, G61, and G62 codes should be reassigned. Our
clinical advisors reviewed all the current neurological comorbidity
subgroups and determined that the Neurological 11 comorbidity subgroup
clinically remains the most appropriate comorbidity subgroup for codes
G60, G61, and G62. However, we may consider additional neurological
comorbidity subgroups in the future and, if appropriate, will reassign
ICD-10 CM diagnosis codes if needed.
7. Request for Rheumatic Tricuspid Valve Disease Diagnoses Subgroup,
I08.- Codes To Be Assigned to the Heart 9 Comorbidity Subgroup
We reviewed the ICD-10 CM diagnosis subgroup I08.X, related to
rheumatic disorders involving valves. Table 12 lists these codes, their
description, their current assigned clinical group, and comorbidity
subgroup.
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Our clinical advisors agree that these codes are clinically
appropriate for inclusion in the Heart 9 comorbidity subgroup when
listed as a secondary diagnosis. When we reassigned the codes listed in
Table 12 to Heart 9, there was no change to the comorbidity adjustment
for these codes (for example, no change in payment).
Final Decision: After reviewing the requested diseases and
disorders for a clinical group or comorbidity subgroup reassignment, we
are finalizing the reassignments of the following ICD-10 CM diagnosis
codes: The ICD-10 CM diagnosis codes in the Neurological 3 comorbidity
subgroup will be reassigned to the Behavioral 4 comorbidity subgroup;
Sepsis, specified by organism, ICD-10 CM codes A40.0 through A40.9 and
A41.01 through A41.89 will be assigned to the Infectious 1 comorbidity
subgroup (note that while these codes will now be a part of the
Infectious 1 comorbidity subgroup, we remind stakeholders that category
A40 ``streptococcal sepsis'' and category A41 ``other sepsis'' have a
code first note. If both the principal and secondary
[[Page 62265]]
diagnoses are from category A40 and A41, there will not be a
comorbidity adjustment, as both are listed from the same diagnosis
subchapter); Leukemia in relapse and histiocytosis ICD-10 CM diagnosis
codes will be assigned to the Neoplasm 22 comorbidity subgroup; The
EXX.43 ICD-10 CM diagnosis codes will be reassigned to the Neurological
10 comorbidity subgroup; The I08.X ICD-10 CM diagnosis codes will be
assigned to the Heart 9 comorbidity subgroup. Table 13 in this section
of the rule shows the final ICD-10 CM diagnosis code comorbidity
subgroup reassignments. We did not reassign any clinical group for any
ICD-10 CM diagnosis code. The final CY 2022 Clinical Group and
Comorbidity Adjustment Diagnosis List is posted on the HHA Center
webpage.\6\
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\6\ HHA Center webpage: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
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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). In the CY 2019 HH PPS final rule
with comment period (83 FR 56515), we finalized a policy 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). To generate the final recalibrated CY 2022 case-mix weights, we
used CY 2020 home health claims data with linked OASIS data (as of July
12, 2021). These data are the most current and complete data available
at this time. The tables later in this section have been revised to
reflect the results using the updated data.
In the CY 2022 HH PPS proposed rule (86 FR 35874), we stated that
we believe that recalibrating the case-mix 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 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 case-mix 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 13 for further information on the OASIS items used for the
functional impairment level under the PDGM. We measure resource use
with the cost-per-minute + 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 HHA 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
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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 the 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 14 shows the coefficients
of the payment regression used to generate the weights, and the
coefficients divided by average resource use.
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The case-mix weights finalized for CY 2022 are listed in Table 15
and is posted on the HHA Center webpage.\7\
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\7\ HHA Center Webpage: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
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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 noted that CY 2020 is the first year of actual
PDGM utilization data, therefore, if we were to use CY 2019 data due to
the COVID-19 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
(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 1.0396. 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 invited comments on the CY 2022 proposed case-mix weights and
proposed case-mix weight budget neutrality factor and comments are
summarized later in this section.
Comment: MedPAC supports CMS' proposal to use CY 2020 data to
recalibrate the PDGM case-mix weights for CY 2022.
Response: We thank MedPAC for its support.
Comment: Many commenters were generally opposed to the proposal to
recalibrate the PDGM case-mix weights for CY 2022. These commenters
expressed concerns about the influence of the COVID-19 PHE on the types
of patients receiving home health care, and the use of CY 2020 data.
These commenters believe that CY 2020 utilization will likely not be
representative of utilization patterns in CY 2022. One commenter stated
that the trends seen in 2020 and 2021 will not hold permanently, and
therefore data from these periods would be skewed if used in modifying
the PDGM rate structure or case-mix weight recalibration. Another
commenter cautioned against the use of CY 2020 data for recalibration
and stated that the COVID-19 PHE directly led to shifts in referral
sources, and increases in the severity of cases. One commenter
expressed concern by what they describe as ``the inconsistency in the
usage of CY 2020 data, when both case-mix weights and LUPAs rates are
dependent upon utilization and care patterns.'' Another commenter
stated that while annual recalibration of case-mix weights is generally
appropriate to ensure that that case-mix weights reflect recent trends
in utilization and resource, the COVID-19 PHE has had significant
effects on home health utilization and overall case-mix severity in CY
2020. Several commenters recommended that CMS maintain the structure
and design of the PDGM for CY 2022.
Response: We acknowledge commenter statements and concerns as to
how the COVID-19 PHE affected home health utilization in CY 2020 as
well as potential impact to CY 2021 utilization. However, we continue
to believe that it is important to base the PDGM case-mix weights on
actual PDGM utilization data and patient resource and shift away from
the use of data prior to the implementation of the PDGM, where
utilization was influenced by different incentives, such as the therapy
thresholds used in case-mix adjustment prior to the PDGM. As stated in
the CY 2022 HH PPS proposed rule (86 FR 35892), 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 COVID-19 PHE would have
impacted utilization within all case-mix groups similarly. Therefore,
the impact of any reduction in resource use caused by the COVID-19 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, 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). Finally, we note that if we
chose not to recalibrate for CY 2022, it would be the third calendar
year without an update to the case-mix weights. We believe that
prolonging recalibration could lead to more significant variation in
the case-mix weights than what is observed using CY 2020 utilization
data.
Comment: One commenter expressed concern with the frequency of
case-mix weight recalibration. This commenter
[[Page 62281]]
believes that CMS should not recalibrate the case-mix weights for CY
2022 because annual changes are too frequent. This commenter
recommended that CMS change the frequency of recalibration from
annually to no more often than every three years.
Response: We thank the commenter for the recommendation. In the CY
2019 HH PPS final rule, we finalized our proposal to annually
recalibrate the PDGM case-mix weights (83 FR 56515) to reflect the most
recent utilization data available at the time of rulemaking. We stated
that annual recalibration of the HH PPS case-mix weights ensures that
the case-mix weights reflect, as accurately as possible, current home
health resource use and changes in utilization patterns. Any changes to
the frequency of the recalibration of the case-mix weights would need
to be proposed through notice and comment rulemaking.
Final Decision: We are finalizing the recalibration of the HH PPS
case-mix weights as proposed for CY 2022. We are also finalizing the
proposal to implement the changes to the PDGM case-mix weights in a
budget neutral manner by applying a case-mix budget neutrality factor
to the CY 2022 national, standardized 30-day period payment rate. As
stated previously, the final case-mix budget neutrality factor for CY
2022 will be 1.0396.
4. CY 2022 Home Health Payment Rate Updates
a. 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 our policy that the labor share is 76.1 percent
and the non-labor 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, 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 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. In the CY 2022 HH PPS proposed rule, we
proposed a market basket update of 2.4 percent (based on IHS Global
Inc.'s first-quarter 2021 forecast with historical data through fourth-
quarter 2020) (86 FR 35909). The CY 2022 proposed home health market
basket update of 2.4 percent was 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), of
0.6 percentage point for CY 2022. In effect, the proposed home health
payment update percentage for CY 2022 was 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 proposed home health
payment update was -0.2 percent (1.8 percent minus 2 percentage
points). We also proposed that if more recent data became available
after the publication of the 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 (86 FR 35909).
Comment: Several commenters had concerns with the market basket
update factor. The commenters noted that the HH PPS market basket
update factor has recently declined from 3.0 percent in CY 2019 to 2.4
percent in CY 2022. They stated this is likely because the market
basket price indices do not reflect the pandemic-driven inflation in
large part because the market basket composite index is determined on a
4-quarter rolling average basis and reflect general cost changes across
the healthcare industry--failing to account for home health specific
price changes on a real-time and industry specific basis.
They also stated that the COVID-19 PHE in CY 2020 has in some part
affected the supply of and demand for certain inputs, including home
health labor leading to a general increase in labor and other input
prices. For example, the pandemic intensified staffing shortages for
HHAs as home health workers left their jobs due to fear of exposure to
the virus. As such, HHAs had to raise wages to attract adequate staff.
Additionally, the commenters stated that the CMS HH PPS market basket
price indexes and cost weight categories may not capture increased
telehealth and personal protective equipment (PPE) costs that HHAs
faced as a result of the pandemic. The commenters provided an example
of data from a Partnership for Quality Home Healthcare (PQHH) member
HHA that suggested that in March and April of CY 2020, average pricing
for masks and gowns approximately increased 8 and 6 times,
respectively.
The commenters also noted that in CY 2020, some portion of home
health visits were shifted to telehealth during the COVID-19 PHE. The
commenters stated that HHAs can report costs of telehealth on the HHA
cost report, but incompletely, which implies that cost weights and
price proxies in CY 2020 and future years fail to accurately account
for telehealth use.
One commenter also constructed an estimated market basket index
using results from the 2021 PQHH Labor Cost Survey related to the three
largest components of the market basket index (wages and salaries,
benefits, and administrative and general expenses). Based on this
analysis, the commenter determined that the home health specific market
basket update factor should have increased by approximately 1.1
percentage points between CY 2019 and CY 2020 and by approximately 1.2
percentage points between CY 2020 and CY 2021. The commenter noted that
these results were in stark contrast to CMS HH PPS market basket update
factors that decreased by 0.1 percentage point between CY 2019 and CY
2020, and further by 0.6 percentage point between CY 2020 to CY 2021.
[[Page 62282]]
The commenter noted that CMS' indicated in the CY 2021 final rule
that the lower update (2.3 percent) for CY 2021 was ``primarily driven
by slower anticipated compensation growth for both health-related and
other occupations as labor markets were expected to be significantly
impacted during the recession that started in February 2020 and
throughout the anticipated recovery.'' In contrast, their results
showed that HHA wages grew at a slightly higher rate between 2019 and
2021, although underlying data shows that therapy professions primarily
those in urban areas experienced a decline in wage growth in 2020. In
addition, the commenter stated that the significant increase in
benefits costs and administrative, general, and other costs seem to
influence a large part of their increase in the estimated market basket
constructed from the survey data. The commenter noted that these
results reflect that the COVID-19 pandemic in 2020 likely resulted in
price inflation for most HHA inputs as opposed to a recession and
highlight the need for CMS to consider using price proxies that
accurately reflect trends in the home health industry.
Response: We appreciate the comment and the commenter's analysis of
home health agency costs. The 2016-based home health market basket is a
fixed-weight, Laspeyres-type price index that measures the change in
price, over time, of the same mix of goods and services purchased in
the base period. The effects on total costs resulting from changes in
the mix of goods and services purchased subsequent to the base period
are not measured.
Any increase in costs as a result of the COVID-19 PHE (to the
extent they differ from the price increase of the 2016-based home
health market basket) would not be reflected in the market basket
update factor. Changes in costs would be reflected when the market
basket cost weights are updated to incorporate more recent home health
agency cost data.
The current HHA market basket cost weights are based on Medicare
cost report data from 2016. Typically, a market basket is rebased every
four to five years. However, we continually monitor the cost weights in
the market baskets to ensure they are reflecting the mix of inputs used
in providing services. We do not yet have cost report data available to
determine the impact of the COVID-19 PHE on HHA cost structures. When
the data becomes available, we will review the 2020 Medicare cost
report data to evaluate the impact of the COVID-19 PHE as well as
implementation of the PDGM and determine whether a rebasing of the
market basket cost weights is appropriate. Any future rebasing or
revising of the HHA market basket will be proposed and subject to
public comments in future rulemaking.
We disagree with the commenter that the price proxies used in the
HHA market basket do not accurately reflect trends in the home health
industry. The price proxies used in the market basket represent the
price indices that correspond with the relevant cost categories (which
were determined using HHA Medicare cost report data and Bureau of
Economic Analysis Benchmark Input-Output data for NAICS 621600, Home
Health Care Services), capturing the overall inflation of these
products or services. Specifically, the aggregate compensation price
proxy reflects the occupational composition of the home health industry
(healthcare and nonhealthcare) published by the BLS Office of
Occupational Employment Statistics. About 25 percent of the home health
market basket is proxied by the Employment Cost Index (ECI) for Wages
and Salaries and ECI for Benefits for civilian hospital workers,
reflecting the price increases for compensation for skilled healthcare
workers that are also employed by HHAs. Another 27 percent of the home
health market basket is proxied by the ECI for Wages and Salaries and
ECI for Benefits for healthcare social assistance workers, reflecting
the price increases for compensation for overall healthcare workers
such as home health aides and nursing aides. A description of the
detailed methodology used to develop the 2016-based HHA market basket
can be found in the CY 2019 final rule (83 FR 56427).
For this final rule, based on IHS Global Inc.'s (IGI's) third
quarter 2021 forecast, the CY 2022 increase in the 2016-based home
health market basket is 3.1 percent (compared to the proposed rule of
2.4 percent), which is primarily due to forecasted higher compensation
prices. The revised higher forecast for compensation prices for CY 2022
reflects the recent faster historical trends, lower projected labor-
force participation, and higher anticipated overall inflation as
compared to IGI's first quarter 2021 forecast.
We understand the commenter's concern for adequate price increase
and payment for Medicare services. As noted in the previous comment by
the Medicare Payment Advisory Commission, Medicare margins are
estimated to be roughly 15 percent in 2019. In addition, we would note
that the increase in the home health market basket used for the HHS PPS
(that is based on a forecast) over the CY 2010 to CY 2020 time period
has exceeded the resulting actual increase in the home health market
basket by an average of 0.5 percentage point each year.
Comment: Several commenters supported CMS' proposal to increase
aggregate payments in CY 2022 by 1.8 percent; however, they stated that
due to the increased demand on the home health industry as a result of
the COVID-19 PHE as well as the lack of coverage for home health
services delivered remotely, they strongly encouraged CMS to implement
a larger increase.
The commenters stated that annual increases to the home health
payment rates have not kept pace with recent increases in home health
providers' staffing and other costs, and that CMS should consider
rising labor costs in particular when finalizing rates for CY 2022.
They noted that patients are safest at home during a pandemic, and home
health providers risk their own safety to ensure that these patients
continue to receive quality care with minimum exposure. Therefore, they
believed HHAs should be adequately reimbursed.
Several commenters recommended that CMS establish a process and
methodology to modify home health agency payment systems and rates
during a PHE to address new costs triggered by the COVID-19 PHE or
unpredicted limitations in payment models. They stated that CMS
modified both the market basket increase and productivity adjustment in
other sectors in final rules that take effect on October 1, 2021;
however, they believe neither those changes in other sectors, nor the
proposed 2022 rate adjustment in home health services adequately
accounts for the increased costs of care in 2021 that are highly likely
to continue in 2022.
The commenters stated that foremost among the cost increases not
adequately represented in the market basket increase are personal
protective equipment and other infection control costs. They stated
that the market basket index reflects increases in the cost of goods
and labor, but it does not address new costs or volume increases in the
use of such items as PPE. While the end of the COVID-19 PHE is
unfortunately not known, commenters stated that they believe it is
reasonable and fair to conclude that the use of PPE will be maintained
at levels comparable to 2020 throughout 2021 and into 2022. As such,
the commenters stated that the increased cost of care, as experienced
in 2020-2021, as it relates to PPE will continue in 2022. They stated
that CMS could include a PPE cost add-on to the
[[Page 62283]]
2022 payment episodic and per visit payment rates. The commenters
stated that conceptually, an add-on has been used in Medicare home
health services previously to reflect the administrative costs of OASIS
and other administrative activities for LUPA-only patient care.
Response: We appreciate the commenters' support for the use of the
productivity-adjusted market basket to annually update HH PPS payments.
As proposed, we are using the latest available data to determine the CY
2022 home health market basket update and productivity adjustment for
this final rule.
We recognize the unique challenges and market conditions as a
result of the COVID-19 PHE, but based on the data available we continue
to believe that the home health market basket adequately captures
changes in prices associated with providing home health services. As
described in the CY 2019 Home Health PPS final rule with comment period
(83 FR 56427), the cost weights were calculated using the 2016 Medicare
cost report data, which is provided directly by freestanding home
health agencies. The price proxies used in the market basket reflect a
projection of the expected price pressures for each category of
expenses.
We contract with IHS Global Inc. (IGI) to purchase their quarterly
forecasts of the price proxies that are used in the market baskets and
multifactor productivity (MFP) that is used to determine the
productivity adjustment, to ensure independence of the projections.
Consistent with our proposal to use more recent data as they become
available, for this final rule we have incorporated more current
historical data and revised forecasts provided by IGI that factor in
expected price and wage pressures. By incorporating the most recent
estimates available of the market basket update and productivity
adjustment, we believe these data reflect the best available projection
of input price inflation faced by HHAs for CY 2022, adjusted for
economy-wide productivity, which is required by statute.
We understand the commenters' concerns that the COVID-19 PHE had
unexpected effects on operating costs for healthcare providers,
including additional expenses related to PPE costs and services
furnished remotely, for which HHAs are not paid directly. Section
1895(e)(1)(A) of the Act prohibits payment for home health services
furnished via a telecommunications system, if such services substitute
for in-person home health services ordered as part of a plan of care.
These remote services also cannot be considered a home health visit for
purposes of eligibility or payment; however, we do acknowledge the
importance of these services during a PHE and beyond. In the CY 2021
final rule (85 FR 70323), we modified the language at Sec. 409.46(e)
allowing a broader use of telecommunications technology to be reported
as allowable administrative costs on the home health cost report,
recognizing that these services have the potential to improve
efficiencies, expand the reach of healthcare providers, allow more
specialized care in the home, and allow HHAs to see more patients or to
communicate with patients more often.
We disagree that the market basket methodology should be modified
from the current methodology to account for the incorporation of costs
during this or future PHEs. The market baskets account for changes in
provider input expenses in two ways: (1) Through the base year cost
weights; and (2) through the projected price pressures for each cost
category as measured by each of the price proxies.
As previously explained, the CMS market baskets are Laspeyres-type
price indexes where relative cost weights are established for a base
year. The major cost weights for the home health market basket are
currently based on the reported expenses for the universe of home
health agencies for 2016 on the Medicare Cost Report, and we
periodically rebase the cost weights for each of the CMS market baskets
to update the relative cost shares. Generally, these base year weights
are updated within a five-year timeframe during a rebasing and revising
of the market basket; this allows for the market baskets to reflect
changes in the spending patterns of providers across the various cost
categories. We have found that these cost weights typically do not
change substantially from year to year. The Medicare Cost Report data
are available with a time lag (for example, the most recent complete
data available for home health agencies would reflect 2019 experience).
We did not propose to rebase or revise the HHA market basket for CY
2022; however, as stated previously, we plan to review the 2020
Medicare cost report data when they become available to determine
whether the distribution of costs faced by HHAs is different when
compare to prior years. Any future rebasing or revising of the HHA
market basket will be proposed and subject to public comments in future
rulemaking.
Consistent with our proposal to use more recent data, the HHA CY
2022 market basket increase factor is 2.6 percent (3.1 percent market
basket update reduced by 0.5 percentage point productivity adjustment)
reflecting IGI's 2021 third quarter forecast. The proposed HHA CY 2022
market basket increase factor based on IGI's 2021 first quarter
forecast was 1.8 percent.
Comment: MedPAC recognized that CMS must provide the statutorily
mandated payment update, but they stated that this increase is not
warranted based on their analysis of payment adequacy. In their March
2021 report to the Congress, the Commission found positive access,
quality, and financial indicators for the sector, with margins of 15.8
percent for freestanding HHAs in 2019. Though consistent with statute,
they believe that a payment update of 1.8 percent will keep payments
higher than necessary for adequate access to quality care. They noted
that the Commission recommended that the Congress reduce the 2021
Medicare base payment rate for HHAs by 5 percent for the 2021 payment
year.
Response: We appreciate MedPAC's concern regarding the payment
increase for HHAs; however, we do not have the statutory authority to
implement its recommendation.
Final Decision: As proposed, we are finalizing our policy to use
more recent data to determine the home health payment update percentage
for CY 2022 in this final rule. Based on IHS Global Inc.'s third-
quarter 2021 forecast with historical data through second-quarter 2021,
the home health market basket update is 3.1 percent. The CY 2022 home
health market basket update of 3.1 percent is then reduced by a
productivity adjustment of 0.5 percentage point for CY 2022. For HHAs
that submit the required quality data for CY 2022, the home health
payment update is a 2.6 percent increase. For HHAs that do not submit
the required quality data for CY 2022, the home health payment update
is 0.6 percent (2.6 percent minus 2 percentage points).
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 proposed 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
[[Page 62284]]
differences, using inpatient hospital wage data is appropriate and
reasonable for the HH PPS.
In the CY 2021 HH PPS final rule (85 FR 70298), we finalized the
proposal to adopt the revised Office of Management and Budget (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 proposed 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 proposed to continue
to use the same methodology discussed in the CY 2007 HH PPS final rule
(71 FR 65884) to address those geographic areas in which there are no
inpatient hospitals. For rural areas that do not have inpatient
hospitals, we proposed to use the average wage index from all
contiguous Core Based Statistical Areas (CBSAs) as a reasonable proxy.
Currently, the only rural area without a hospital from which hospital
wage data could be derived is Puerto Rico. However, for rural Puerto
Rico, we do not apply this methodology due to the distinct economic
circumstances that exist there (for example, due to the close proximity
to one another of almost all of Puerto Rico's various urban and non-
urban areas, this methodology would produce a wage index for rural
Puerto Rico that is higher than that in half of its urban areas).
Instead, we proposed to continue to use the most recent wage index
previously available for that area. The most recent wage index
previously available for rural Puerto Rico is 0.4047. For urban areas
without inpatient hospitals, we use the average wage index of all urban
areas within the State as a reasonable proxy for the wage index for
that CBSA. For CY 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 0.8539.
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing
revisions to the delineations of MSAs, Micropolitan Statistical Areas,
and CBSAs, and guidance on uses of the delineation of these areas. In
the CY 2015 HH PPS final rule (79 FR 66085,66087), 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 0.8738. 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-revised-delineations-of-metropolitan-statistical-areas.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 proposed 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.
We received several comments on the CY 2022 home health wage index
proposals. A summary of these comments and our responses are as
follows:
Comment: A few commenters recommended overarching changes to the
home health wage index including the creation of a home health specific
wage index, allowing home health agencies to appeal their wage index
values or utilize geographic reclassification, and establishing a home
health floor of 0.80 similar to the hospice floor.
Response: While we thank the commenters for their recommendations,
these comments are outside the scope of the proposed rule. Any changes
to the way we adjust home health payments to account for geographic
wage differences, beyond the wage index proposals discussed in the CY
2022 HH PPS proposed rule (86 FR 35874), would have to go through
notice and comment rulemaking. While CMS and other stakeholders have
explored potential alternatives to using OMB's statistical area
definitions, CMS continues to explore potential alternatives to explore
alternatives to using OMB's delineations but we continue to believe
that in the absence of home health specific wage data, using the pre-
floor, pre-reclassified hospital wage data is appropriate and
reasonable for home health payments. The reclassification provision at
section 1886(d)(10)(C)(i) of the Act states that the Board shall
consider the application of any subsection (d) hospital requesting the
Secretary change the hospital's
[[Page 62285]]
geographic classification. The reclassification provision found in
section 1886(d)(10) of the Act is specific to hospital inpatient
prospective payment system (IPPS) hospitals only.
Additionally, the application of the hospice floor is specific to
hospices and does not apply to HHAs. The hospice floor was developed
through a negotiated rulemaking advisory committee, under the process
established by the Negotiated Rulemaking Act of 1990 (Pub. L. 101-648).
Committee members included representatives of national hospice
associations; rural, urban, large, and small hospices; multi-site
hospices; consumer groups; and a government representative. The
Committee reached consensus on a methodology that resulted in the
hospice wage index. Because the reclassification provision applies only
to hospitals, and the hospice floor applies only to hospices, we
continue to believe the use of the pre-floor and pre-reclassified
hospital wage index results in the most appropriate adjustment to the
labor portion of the home health payment rates. This position is
longstanding and consistent with other Medicare payment systems (for
example, SNF PPS, IRF PPS, and Hospice).
Comment: A commenter stated that the pre-floor, pre-reclassified
hospital wage index is inadequate for adjusting home health costs,
particularly in States like New York which has among the nation's
highest labor costs now greatly exacerbated by the States'
implementation of a phased in $15 per hour minimum wage hike, the
balance of which is unfunded by Medicare''.
Response: Regarding minimum wage standards, we note that such
increases would be reflected in future data used to create the hospital
wage index to the extent that these changes to State minimum wage
standards are reflected in increased wages to hospital staff.
Comment: A few commenters recommended that CMS reconsider its
decision to apply the new OMB geographic designations for CBSAs in the
annual wage index update. Specifically, commenters had concerns with
wages index decreases for counties in New Jersey that moved from the
New York City Metropolitan CBSA and now make up the newly created New
Brunswick-Lakewood, NJ, CBSA as well as Franklin County, Massachusetts,
that moved from rural to urban status.
Response: We remind commenters that the revised OMB delineations
were finalized in the CY 2021 HH PPS final rule (85 FR 70306).
Additionally, we continue to believe it is important for the home
health wage index to use the latest OMB delineations available in order
to maintain an accurate and up-to-date payment system that reflects the
reality of population shifts and labor market conditions. We note that
the wage-index value is applied to home health payments are based on
where the individual is receiving home health services and not the
location of the home health agency. For example, if a home health
agency in New Jersey is servicing a patient in the New York City
Metropolitan CBSA, the wage index for New York City would apply to the
payment.
Comment: A few commenters stated that providers should be protected
against substantial payment reductions due to dramatic reductions in
wage index values from 1 year to the next and recommended that CMS
maintain the 5 percent cap that was put in place for CY 2021. A
commenter recommended that CMS should implement a 2 percent cap on wage
index decreases for CY 2022. Other commenters recommended that CMS
adopt a transition policy for home health providers that mirrors the 5-
percent cap on annual wage index reductions included in the FY 2022
IPPS/LTCH PPS final rule.
Response: We appreciate the suggestions for improving the HH PPS
wage index. We did not propose changes to the HH PPS wage index
methodology for CY 2022, and therefore we are not finalizing any
changes to that methodology in this final rule. However, we will take
these comments into consideration to potentially inform future
rulemaking.
Comment: A commenter stated that rural areas are disproportionately
affected by what the commenter artificially reduced rural hospital wage
indices. This commenter believes that in areas with lower population
densities, travel costs are increased because of the time and mileage
involved in traveling from patient to patient to provide services, and
the current method of adjusting labor costs using the hospital wage
index does not accurately account for increased travel costs and lost
productivity in serving rural areas.
Response: As discussed in the CY 2017 HH PPS final rule (81 FR
76721), we do not believe that a population density adjustment is
appropriate at this time. Rural HHAs continually cite the added cost of
traveling from one patient to the next. However, urban HHAs cite the
added costs associated with needed security measures and traffic
congestion. The home health wage index values in rural areas are not
necessarily lower than the home health wage index values in urban
areas. The home health wage index reflects the wages that inpatient
hospitals pay in their local geographic areas.
Final Decision: After considering the comments received in response
to the CY 2022 HH PPS proposed rule, we are finalizing our proposal to
continue to use the pre-floor, pre-reclassified hospital inpatient wage
index with no 5 percent cap on wage index decreases as the wage
adjustment to the labor portion of the HH PPS rates. For CY 2022, the
updated wage data are for the hospital cost reporting periods beginning
on or after October 1, 2017 and before October 1, 2018 (FY 2018 cost
report data).
The final CY 2022 HH PPS 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 Sec. 484.220, we adjust the national, standardized
prospective payment rates by a case-mix relative weight and a wage
index value based on the site of service for the beneficiary. To
provide appropriate adjustments to the proportion of the payment amount
under the HH PPS to account for area wage differences, we apply the
appropriate wage index value to the labor portion of the HH PPS rates.
In the CY 2019 HH PPS final rule with comment period (83 FR 56435), we
finalized rebasing the home health market basket to reflect 2016
Medicare cost report 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 our policy
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 wage-adjusted 30-day
period payment amount for CY 2022:
Multiply the national, standardized 30-day period rate by
the patient's applicable case-mix weight.
[[Page 62286]]
Divide the case-mix adjusted amount into a labor (76.1
percent) and a non-labor portion (23.9 percent).
Multiply the labor portion by the applicable wage index
based on the site of service of the beneficiary.
Add the wage-adjusted portion to the non-labor portion,
yielding the case-mix and wage adjusted 30-day period 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 Sec. 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
Sec. Sec. 484.205(d)(1) and 484.230.
A PEP adjustment as set forth in Sec. Sec. 484.205(d)(2)
and 484.235.
An outlier payment as set forth in Sec. Sec.
484.205(d)(3) and 484.240.
(2) CY 2022 National, Standardized 30-Day Period Payment Amount
In the CY 2022 HH PPS proposed rule (86 FR 35880), CMS provided
preliminary monitoring data for the first year of the 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. For CY 2022, we did not propose to make any
additional permanent or temporary adjustments to the national,
standardized 30-day period payment 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 final 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 final case-mix
weights budget neutrality factor for CY 2022 is 1.0396.
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
decided to continue our practice of using the most recent and complete
home health claims data available; that is why we used CY 2020 claims
data for the CY 2022 payment rate updates.
To calculate the wage index budget neutrality factor, we first
determine the payment rate needed for non-LUPA 30-day periods using the
CY 2022 wage index so those total payments are equivalent to the total
payments for non-LUPA 30-day periods using the CY 2021 wage index and
the CY 2021 national standardized 30-day period payment rate adjusted
by the case-mix weights recalibration neutrality factor. Then, by
dividing the payment rate for non-LUPA 30-day periods using the CY 2022
wage index by the payment rate for non-LUPA 30-day periods using the CY
2021 wage index, we obtain a wage index budget neutrality factor of
1.0019. We then apply the wage index budget neutrality factor of 1.0019
to the 30-day period payment rate.
Next, we update the 30-day period payment rate by the CY 2022 home
health payment update percentage of 2.6 percent. The CY 2022 national,
standardized 30-day period payment rate is calculated in Table 16.
[GRAPHIC] [TIFF OMITTED] TR09NO21.030
The CY 2022 national, standardized 30-day period payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2022 home health payment update of 2.6 percent minus 2 percentage
points and is shown in Table 17.
[[Page 62287]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.031
(3) CY 2022 National Per-Visit Rates for 30-day Periods of Care
The national per-visit rates are used to pay LUPAs and to compute
imputed costs in outlier calculations. The per-visit rates are paid by
type of visit or home health 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 per-visit 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 per-visit
payments. We calculated the wage index budget neutrality factor by
simulating total payments for LUPA 30-day periods of care using the CY
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
payment rates for LUPA 30-day periods of care using the CY 2022 wage
index by the payment rates for LUPA 30-day periods of care using the CY
2021 wage index, we obtained a wage index budget neutrality factor of
1.0019. 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 2.6 percent. The national per-visit rates are
adjusted by the wage index based on the site of service of the
beneficiary. The per-visit payments for LUPAs are separate from the
LUPA add-on payment amount, which is paid for episodes that occur as
the only episode or initial episode in a sequence of adjacent episodes.
The CY 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 2.6 percent and are shown in Table 18.
[GRAPHIC] [TIFF OMITTED] TR09NO21.032
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 2.6 percent minus 2 percentage points and are
shown in Table 19.
[[Page 62288]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.033
The following is a summary of the public comments received about
the CY 2022 payment update and our response.
Comment: Several commenters stated their support for the CY 2022
home health payment update. However, many stated that with the
increasing demand of the home health industry because of the COVID-19
PHE, CMS should consider increasing Medicare payments to ensure that
HHAs are able to provide quality care. MedPAC mentioned that though CMS
was updating payment rates according to statute, they believe that
payments were higher than necessary and should be reduced.
Additionally, several commenters recommended that CMS establish a
process and methodology to modify HHA payment systems and rates when an
extreme and uncontrollable circumstance (for example, PHE) occurs to
accurately account for new costs triggered by the emergency, such as
personal protective equipment (PPE).
Response: We thank commenters for expressing their concerns. CMS is
statutorily required to update the payment rates under the prospective
payment system by the home health percentage in accordance with section
1895(b)(3)(B) of the Act. We understand commenters' request to
establish a process to modify payments during an unforeseen
circumstance, such as a PHE. However, we do not have the statutory
authority to modify the HH PPS methodology, in the event of an extreme
and uncontrollable circumstance.
Final Decision: For CY 2022, we are finalizing the national,
standardized 30-day payment rates, the per-visit payment rates, and the
home health payment update percentage of 2.6 percent for providers
submitting quality data and 0.6 percent for those not submitting
quality data.
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 subsequent years would mirror that
of the RAP in CY 2021. Starting in CY 2022, HHAs will submit a one-time
NOA that establishes the home health period of care and covers all
contiguous 30-day periods of care until the individual is discharged
from Medicare home health services. Also, for the one-time NOA for CYs
2022 and subsequent years, we finalized a payment reduction if the HHA
does not submit the NOA within 5 calendar days from the start of care.
That is, if an HHA fails to submit a timely NOA for CYs 2022 and
subsequent years, the reduction in payment amount would be equal to a
1/30 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 1/30 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 subsequent days (An NOA submitted on
and after this date would 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 Sec. 484.205(j)(4). Specifically, we finalized
our policy that CMS may waive the consequences
[[Page 62289]]
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
Sec. 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.
Though we did not solicit comments on the previously finalized NOA
process for CY 2022, we did receive several comments on various
components of the finalized policy. However, these comments were out of
scope of the proposed rule because we did not propose to make any
changes to the finalized policy. 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 Sec. 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 speech-language pathology
visit in LUPA periods that occur as the only period of care or the
initial 30-day period of care in a sequence of adjacent 30-day periods
of care by the appropriate add-on factor (1.8451 for SN, 1.6700 for PT,
and 1.6266 for SLP) to determine the LUPA add-on payment amount for 30-
day periods of care under the PDGM. For example, using the final 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 $289.50 (1.8451
multiplied by $156.90), subject to area wage adjustment.
(5) Occupational Therapy LUPA Add-On Factor
In order to implement Division CC, section 115, of CAA 2021, we
proposed conforming changes to regulations at Sec. 484.55(a)(2) and
(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
proposed 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 is no sufficient data regarding the average excess of
minutes for the first visit in LUPA periods when the initial and
comprehensive assessments are conducted by occupational therapists.
Therefore, we proposed 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 the
similarity in the per-visit payment rates for both PT and OT make the
PT LUPA add-on factor the most appropriate proxy. We solicited comments
on this proposal.
Comment: Commenters were in support of CMS creating an OT add-on
factor for the OT LUPA add-on payments. Additionally, there was support
utilizing the PT LUPA add-on factor as a proxy until there is enough CY
2022 data to create an OT add-on factor for the OT LUPA add-on
payments.
Response: We thank commenters for their support of the OT add-on
factor.
Final Decision: We are finalizing our proposal to use the PT add-on
factor as a proxy for the OT add-on factor, until we have sufficient CY
2022 data to create an OT add-on factor.
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 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
[[Page 62290]]
amount otherwise made under section 1895 of the Act for home health
services provided in a rural area (as defined in section 1886(d)(2)(D)
of the Act), for episodes and visits ending before January 1, 2019.
(2) Rural Add-on Payments for CYs 2019 through CY 2022
Section 50208(a)(1)(D) of the BBA of 2018 added a new subsection
(b) to section 421 of the MMA to provide rural add-on payments for
episodes or visits ending during CYs 2019 through 2022. It also
mandated implementation of a new methodology for applying those
payments. Unlike previous rural add-ons, which were applied to all
rural areas uniformly, the extension provided varying add-on amounts
depending on the rural county (or equivalent area) classification by
classifying each rural county (or equivalent area) into one of three
distinct categories: (1) Rural counties and equivalent areas in the
highest quartile of all counties and equivalent areas based on the
number of Medicare home health episodes furnished per 100 individuals
who are entitled to, or enrolled for, benefits under Part A of Medicare
or enrolled for benefits under Part B of Medicare only, but not
enrolled in a Medicare Advantage plan under Part C of Medicare (the
``High utilization'' category); (2) rural counties and equivalent areas
with a population density of 6 individuals or fewer per square mile of
land area and are not included in the ``High utilization'' category
(the ``Low population density'' category); and (3) rural counties and
equivalent areas not in either the ``High utilization'' or ``Low
population density'' categories (the ``All other'' category).
In the CY 2019 HH PPS final rule with comment period (83 FR 56443),
CMS finalized policies for the rural add-on payments for CY 2019
through CY 2022, in accordance with section 50208 of the BBA of 2018.
The CY 2019 HH PPS proposed rule (83 FR 32373) described the provisions
of the rural add-on payments, the methodology for applying the new
payments, and outlined how we categorized rural counties (or equivalent
areas) based on claims data, the Medicare Beneficiary Summary File and
Census data. The data used to categorize each county or equivalent area
is available in the Downloads section associated with the publication
of this rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file containing the
rural county or equivalent area name, their Federal Information
Processing Standards (FIPS) State and county codes, and their
designation into one of the three rural add-on categories is available
for download.
The HH PRICER module, located within CMS' claims processing system,
would increase the CY 2022 30-day base payment rates, described in
section III.C.3. of this final rule, by the appropriate rural add-on
percentage prior to applying any case-mix and wage index adjustments.
The CY 2019 through CY 2022 rural add-on percentages outlined in law
are shown in Table 20.
[GRAPHIC] [TIFF OMITTED] TR09NO21.034
Though we did not make any proposals regarding the rural add-on
percentages in the CY 2022 HH PPS proposed rule, we did receive some
comments as summarized in this section of this final rule.
Comment: While commenters understood the rural add-on payments
decrease has been mandated by the BBA of 2018, many expressed continued
concern and frustration of the reduction in support for access to rural
beneficiaries. Commenters stated that providers in rural areas face
higher overhead expenses due to increased travel time between patients
as well as demands for extra staff in areas where workforce challenges
already exist. A few commenters suggested that CMS should work with
Congress to provide immediate relief to rural home health providers
that face increased costs responding to patient's during the COVID-19
PHE and to maintain the rural add-on payment at 3 percent in order to
protect Medicare beneficiaries' access to home health in rural
communities.
Response: We thank commenters for their recommendations. We
understand commenter concerns about the phase-out of rural add-on
payments and potential effects on rural HHAs. However, because the
current rural add-on policy is statutory, we have no regulatory
discretion to modify or extend it. CMS will continue to monitor patient
access to home health services and the costs associated with providing
home health care in rural versus urban areas.
Final Decision: Policies for the provision of rural add-on payments
for CY 2019 through CY 2022 were finalized in the CY 2019 HH PPS final
rule with comment period (83 FR 56443), in accordance with section
50208 of the BBA of 2018. The data used to categorize each county or
equivalent area are available in the downloads section associated with
the publication of this rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices. In addition, an Excel file containing
the rural county or equivalent area name, their Federal Information
Processing Standards (FIPS) state and county codes, and their
designation into one of the three rural add-on categories is available
for download.
e. Payments for High-Cost Outliers Under the HH PPS
(1) Background
Section 1895(b)(5) of the Act allows for the provision of an
addition or adjustment to the home health payment amount otherwise made
in the case of outliers because of unusual variations in the type or
amount of medically necessary care. Under the HH PPS 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
[[Page 62291]]
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 wage-adjusted national, standardized 60-day episode payment
rate, which yields an FDL dollar amount for the case. The outlier
threshold amount is the sum of the wage and case-mix adjusted PPS
episode amount and wage-adjusted FDL amount. The outlier payment is
defined to be a proportion of the wage-adjusted estimated cost that
surpasses the wage-adjusted threshold. The proportion of additional
costs over the outlier threshold amount paid as outlier payments is
referred to as the loss-sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397, 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 add-on payment amount, and the NRS conversion factor for CY 2010.
We then reduced the rates by 5 percent as required by section
1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the
Affordable Care Act. For CY 2011 and subsequent calendar years we
targeted up to 2.5 percent of estimated total payments to be paid as
outlier payments, and apply a 10-percent agency-level outlier cap.
In the CY 2017 HH PPS proposed and final rules (81 FR 43737, 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 cost-per-unit approach rather than a cost-per-visit
approach. This change in methodology allows for more accurate payment
for outlier episodes, accounting for both the number of visits during
an episode of care and the length of the visits provided. Using this
approach, we now convert the national per-visit rates into per 15-
minute unit rates. These per 15-minute unit rates are used to calculate
the estimated cost of an episode to determine whether the claim will
receive an outlier payment and the amount of payment for an episode of
care. In conjunction with our finalized policy to change to a cost-per-
unit approach to estimate episode costs and determine whether an
outlier episode should receive outlier payments, in the CY 2017 HH PPS
final rule we also finalized the implementation of a cap on the amount
of time per day that would be counted toward the estimation of an
episode's costs for outlier calculation purposes (81 FR 76725).
Specifically, we limit the amount of time per day (summed across the
six disciplines of care) to 8 hours (32 units) per day when estimating
the cost of an episode for outlier calculation purposes.
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 the 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 propose 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 loss-sharing ratio. A
high FDL ratio reduces the number of periods that can receive outlier
payments, but makes it possible to select a higher loss-sharing ratio,
and therefore, increase outlier payments for qualifying outlier
periods. Alternatively, a lower FDL ratio means that more periods can
qualify for outlier payments, but outlier payments per period must 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 loss-sharing ratio
of 0.80, Medicare pays 80 percent of the additional estimated costs
that exceed the outlier threshold amount. For the proposed rule, with
CY 2020 claims data (as of March 30, 2021), we proposed an FDL ratio of
0.41. Using CY 2020 claims data (as of July 12, 2021) showed that for
CY 2022 the final FDL ratio would need to be 0.40 to pay up to, but no
more than, 2.5 percent of the total payment as outlier payments in CY
2022.
For this final rule, simulating payments using preliminary CY 2020
claims data (as of July 12, 2021) and the CY 2021 HH PPS payment rates
(85 FR 70316), we estimate that outlier payments in CY 2021 would
comprise 2.1 percent of total payments. Based on simulations using CY
2020 claims data (as of July 12, 2021) and the proposed CY 2022 payment
rates presented in Section III.C.2 of this final rule, we estimate that
outlier payments would constitute approximately 1.8 percent of
[[Page 62292]]
total HH PPS payments in CY 2022. Our simulations showed that the FDL
ratio would need to be changed from 0.56 to 0.40 to pay up to, but no
more than, 2.5 percent of total payments as outlier payments in CY
2022.
Comment: A commenter recommended ending the outlier provision and
restore the 5 percent to fund the outlier payments into regular
Medicare payments.
Response: The HH PPS allows for outlier payments to be made to
providers for episodes that have unusually large amounts of cost
because of a patient's home health care needs. Nevertheless, we believe
that section 1895(b)(5)(A) of the Act allows the Secretary the
discretion as to whether or not to have an outlier policy under the HH
PPS. CMS believes the outlier provision is beneficial since it
addresses any additional or unpredictable cost that is medically
necessary for a patient. In addition, we believe outlier payments are
beneficial in helping to mitigate the incentive for HHAs to avoid
patients that need higher levels of medical care.
Final Decision: We are finalizing the fixed-dollar loss ratio of
0.40 for CY 2022 so the estimated total outlier payments are up to, but
not more than, 2.5 percent of the payments estimated to be made under
the HH PPS.
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
Sec. Sec. 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 Sec. 424.22(a)(1)(v)(A), in an acute or post-
acute facility, from which the patient was directly admitted to home
health, the certifying allowed practitioner may be different from the
physician or allowed practitioner that performed the face-to-face
encounter. These regulations text changes are not time 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 Sec. 409.43. Therefore, in the CY
2022 HH PPS proposed rule (86 FR 35915), we proposed conforming
regulations text changes at Sec. 409.43 to reflect that allowed
practitioners, in addition to physicians, may establish and
periodically review the plan of care.
Comment: Commenters were supportive of the proposed conforming
regulations text changes at Sec. 409.43 and noted that they are
appreciative of CMS' attention to updating the regulations to prevent
confusion regarding who is authorized to establish and review the home
health plan of care. Additional commenters requested changes to the
regulations at 42 CFR 424.22.
Response: We thank commenters for their review of the rule and
support of the changes at Sec. 409.43, and note that the suggested
changes at 42 CFR 424.22 are out of scope of this final rule and would
require a notice of proposed rulemaking.
Final Decision: We are finalizing the conforming regulations at
Sec. 409.43, consistent with section 3708 of the CARES Act to allow
``allowed practitioners'' to establish and periodically review the home
health plan of care.
III. Home Health Value-Based Purchasing (HHVBP) Model
A. Expansion of 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
Value-Based 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 volume-based 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 Medicare-certified
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),\8\ 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 2 years' prior; for example, the CY 2018 payment
adjustments were based on CY 2016 performance.
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\8\ OASIS is the instrument/data collection tool used to collect
and report performance data by HHAs.
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[[Page 62293]]
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,\9\ 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.\10\
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\9\ https://www.cms.gov/files/document/certification-home-health-value-based-purchasing-hhvbp-model.pdf.
\10\ https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
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As described in this final rule, we proposed 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 proposed to
codify HHVBP Model expansion policies at Sec. Sec. 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,\11\ 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.
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\11\ The HHVBP Third Annual Evaluation Report is available at
https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
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Impact on Medicare Spending: The CMS Chief
Actuary has certified that expansion of the HHVBP Model would produce
Medicare savings if expanded to all States.\12\
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\12\ The full CMS Actuary Report is available at https://www.cms.gov/files/document/certification-home-health-value-based-purchasing-hhvbp-model.pdf.
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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 stated in the proposed
rule that 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.
We summarize in this section of this rule comments received
regarding the requirements for expansion and our responses.
Comment: Commenters disagreed that CMS has met the statutory
requirement that expansion of the HHVBP Model would not deny or limit
the coverage or provision of Medicare benefits for Medicare
beneficiaries and stated that while incremental improvements in quality
performance and cost-savings are encouraging, they questioned whether
those numbers are sufficient to justify ending the original model early
during a pandemic and expanding it nationwide. Commenters asserted that
access under the original Model was negatively impacted and expansion
of HHVBP will exponentially worsen access to care.
Response: We disagree that expansion of the HHVBP Model should be
suspended or the Model not expanded, or that the Model denies coverage
to people who are not expected to improve. As stated previously, the
original HHVBP Model did not make any changes to coverage or provision
of benefits for Medicare beneficiaries. We further note that evaluation
findings to date show that the implementation of the original HHVBP
Model did not adversely impact home health utilization or market
entries and exits differentially in HHVBP states relative to non-HHVBP
states. We refer readers to Section 3, pages 25-36 in the Evaluation of
the Home Health Value-Based Purchasing (HHVBP) Model Third Annual
Report \13\ for our full analysis on beneficiary access to home health
care covering the post-implementation period 2016-2018 and to Section
3, pages 25-50 in the Evaluation of the Home Health Value-Based
Purchasing (HHVBP) Model Fourth Annual Report \14\ for an updated
analysis covering the post-implementation period 2016-2019. As
previously summarized, the CMS Chief Actuary's certification and the
Secretary's determination were based on evaluation findings.
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\13\ The HHVBP Third Annual Evaluation Report is available at
https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
\14\ https://innovation.cms.gov/data-and-reports/2021/hhvbp-fourthann-rpt.
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3. Overview
We stated in the proposed rule that the proposed HHVBP Model
expansion presents an opportunity to improve the quality of care
furnished to Medicare beneficiaries nationwide through payment
incentives to HHAs. We stated that 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.
We stated in the proposed rule that 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
[[Page 62294]]
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 CMS-
sponsored 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 final rule, all
Medicare-certified HHAs in the 50 States, District of Columbia and the
territories must comply with all applicable fraud and abuse laws and
regulations.
We proposed 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. We stated in the proposed rule that 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
further stated that 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 proposed 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.
We proposed that the 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 proposed to
codify this requirement at Sec. 484.350. We proposed 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 proposed 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 proposed 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 final rule and payment adjustment would be calculated based on an
HHA's CCN.\15\
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\15\ HHAs 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, Sec. 484.20
Available at URL https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-484?toc=1.
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We summarize in this section of this rule comments received on the
proposed timing and scope of the expanded model and our responses.
Comment: The majority of commenters supported a home health value-
based purchasing payment model, but were opposed to expansion beginning
in CY 2022 as the first performance year. Commenters expressed concern
that HHAs continue to contend with challenges of the PHE and that
expansion should be postponed until CY 2023 or the calendar year that
is 1 year post the public health emergency which they stated would be a
more stable time in the trajectory of health care delivery. Commenters
expressed that HHAs need more time to prepare, institute operational
reforms, and learn about the Model and encouraged CMS to provide
technical assistance and training to support HHAs in preparing for the
Model. Commenters stated that CMS should allow for more study time/data
gathering and extend the original HHVBP Model for another year to
collect data that is more reflective of the current state of care
before expanding nationwide. A commenter recommended CMS carefully
evaluate the impact of the HHVBP Model on hospital-operated HHAs as
part of its overall evaluation of the Model before scaling it on a
national level and seek broad stakeholder input on the design of the
HHVBP expanded model in future rulemaking. Commenters requested that
CMS develop a comprehensive plan for implementing the HHVBP model
nationwide in CY 2023 after the conclusion of the original model. A
commenter recommends that CMS make the first year of expansion
voluntary and move to mandatory in CY 2023. We received a few comments
that supported a CY 2022 start date for expansion.
Response: We thank the commenters for their support for a value-
based purchasing payment model in the home health setting. However, we
disagree that additional study time or an extension of the original
Model to collect additional data is needed prior to expansion. The
original Model was tested for four years, CYs 2016-2019. The original
Model has met statutory requirements based on the CMS Chief Actuary's
certification and evaluation findings in the Third Annual Evaluation
Report covering the implementation period 2016-2018 that showed the
Model improved quality of care without increased spending. Updated
analysis of the original Model in the Fourth Annual Evaluation Report,
covering the implementation period 2016-2019, continues to indicate
improved quality of care without increased spending or adverse impacts
on home health utilization, or market entries and exits. We note that
the Fourth Annual Evaluation Report includes evaluation of the impacts
to hospital-operated HHAs, and found that hospital based HHAs (in both
HHVBP and non-HHVBP states) do care for higher risk patients. The model
payment and the primary evaluation impact estimation use risk
adjustment to account for such differences. The evaluation did not
specifically analyze the outcomes by free-standing vs hospital-based
entities in HHVBP and non-HHVBP states. However, we examined whether
there is a pattern of the Model limiting admissions for more medically
complex patients and do not find that to be the
[[Page 62295]]
case. We continued to observe a pattern of increasing clinical severity
over time among all home health patients based on multiple measures of
medical complexity or severity, and the trends were generally similar
in HHVBP and non-HHVBP states. In addition, the CMS Chief Actuary
concluded in its certification that since the selection of the states
was random and participation by HHAs in the selected states was
mandatory, it is unlikely that these evaluation results were biased.
We understand the PHE, declared in January 2020, has had an impact
on HHAs. We also believe that technical assistance and training may
help those HHAs not part of the original Model to prepare for
successful participation in the expanded HHVBP Model.
After consideration of the comments received, we are therefore
finalizing that CY 2022 will be a pre-implementation year, with CY 2023
as the first performance year and CY 2025 as the first payment year, as
we discuss further in this section and later in this rule.
Comment: A commenter stated that expansion should be delayed until
a payment framework is built to adequately account for the differences
in healthcare systems, such as Medicaid safety-net hospitals, that by
definition provide a disproportionate share of charity and other forms
of uncompensated care to individuals who have a high level of social
need, beyond their medical treatment. The commenter also stated that
nationwide implementation of the HHVBP model should be delayed until
the evaluation of appropriate risk adjustment for types of Social
Determinants of Health (SDoH) and payment mechanisms appropriately
account for the interaction of biological, behavioral, and social care
needs when it comes to providing patient-tailored, comprehensive value-
based care.
Response: As shown in Table 21, simulating the expanded HHVBP
Model's national volume-based cohorts with CY 2019 data indicates a
higher average payment adjustment for HHAs with a high percentage of
dually eligible beneficiaries. Consequently, we do not have evidence to
suggest that HHAs that care for beneficiaries with more significant
social risk factors would receive decreased FFS payments under the
expanded Model. We thank the commenter for their recommendations to
evaluate types of Social Determinants of Health (SDoH) to account for
the interaction of biological, behavioral, and social care needs when
it comes to providing patient-tailored, comprehensive value-based care
for potential modifications to risk adjustment and we will take this
under consideration. As noted in section III.A.6.e.2 of this final
rule, we are working collaboratively with HH QRP to determine how data
collected on SDoHs under HH QRP could be part of the HHVBP Model
expansion.
Comment: Commenters stated that CMS should include a ``shared
savings'' component to the expanded HHVBP Model to enhance the
incentives that led HHAs to achieve significant savings to Medicare.
Response: We appreciate this comment, but it is outside the scope
of our proposals on the expansion of the HHVBP Model.
Final Decision: After consideration of comments received, we are
finalizing our proposal with modification. We are finalizing a one-year
delay in assessing HHA performance and the calculation of a payment
adjustment. To allow HHAs time to prepare and learn about the expanded
Model, CY 2023 will be the first performance year and CY 2025 will be
the first payment year, based on CY 2023 performance. CY 2022 will be a
pre- implementation year, as discussed in more detail later in this
rule. We will provide learning support about the Model to HHAs during
CY 2022. We believe that by delaying payment adjustments by one year
and providing HHAs with learning support in the pre-implementation
phase, all HHAs will be better prepared to participate in the Model for
the CY 2023 performance year. HHAs will incur a 0 percent payment
adjustment risk for the CY 2022 pre-implementation year.
We are finalizing as proposed that the expanded Model will 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 will be required to compete in the expanded Model. We are
also finalizing to codify this requirement at Sec. 484.350. We are
finalizing as proposed to define a `competing HHA' within the scope of
the expanded HHVBP Model as an HHA that has a current Medicare
certification and is being paid by CMS for home health care services.
We are finalizing 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 final rule and
payment adjustment will be calculated based on an HHA's CCN. Under our
finalized policy to delay application of payment adjustments under the
expanded Model, all HHAs certified for participation in Medicare before
January 1, 2022, will have their CY 2023 performance assessed and would
be eligible for a CY 2025 payment adjustment.
b. Overview of the Payment Adjustment
We proposed that 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 stated in the proposed rule that 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. We
stated that 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. 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
[[Page 62296]]
own performance during the baseline year. These proposals, as well as
our finalized policies, are discussed in sections III.A.4, III.A.5, and
III.A.7.a of this final rule.
In addition, at Sec. 484.345 we proposed 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
We note that we are generally finalizing the definitions at Sec.
484.345 as proposed, with the addition of the term, pre-implementation
year, to reflect that under our final policy to delay the application
of payment adjustments under the expanded Model, CY 2022 will be a pre-
implementation year. We summarize and respond to any comments received
on particular proposed definitions in the applicable sections of this
rule.
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
Sec. 484.330. For the nationwide expansion of the HHVBP Model, we
proposed 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 volume-based cohorts in determining
benchmarks, achievement thresholds, and payment adjustments.
a. 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 proposed 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 Sec. 484.245(b), and we proposed 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 Sec.
484.245(b)(1)(iii)(A). We clarify in this final rule that, unlike under
the HH QRP, and consistent with the original Model, HHAs would not need
to submit an exemption request for HHCAHPS in accordance with the
regulations at 42 CFR 484.245(b)(1)(iii)(A) for the purposes of
qualifying for the smaller-volume HHA cohort. We stated that 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-and-Protocols/Survey-Materials.\16\
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\16\ Detailed scoring information is contained in the Protocols
and Guidelines manual posted on the HHCAHPS web site and available
at https://homehealthcahps.org/Survey-and-Protocols/Survey-Materials.
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The HH QRP requires, in part, that an HHA submit HHCAHPS survey
data to CMS. An HHA that has fewer than 60 unique HHCAHPS survey-
eligible 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 under the HH QRP. As under the
original HHVBP Model, we proposed to align with this HHCAHPS survey
reporting requirement by defining the larger-volume cohort as those
HHAs that are required to submit an HHCAHPS survey in the performance
year. We note that under the original Model, the HHA is not required to
secure an exemption in order to qualify for the smaller-volume cohort;
rather, CMS assesses whether an HHA qualifies for the smaller-volume
cohort based on the volume of unique patients eligible to submit the
HHCAHPS survey in a calendar year. As under the original Model, we also
proposed 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
Sec. Sec. 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 stated that 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. Cohorts for the Model Expansion
As discussed, we believe that applying separate larger- and
smaller-volume 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); \17\ 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.
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\17\ The 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 final rule.
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Under the original Model, CMS applied a minimum of eight HHAs for
any size cohort, such that a smaller-volume 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. We stated in the
proposed rule that 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
[[Page 62297]]
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, 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 cohorts, the smaller-volume
cohorts would need to be combined with the larger-volume cohorts in
their respective 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 21 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.
[GRAPHIC] [TIFF OMITTED] TR09NO21.035
[[Page 62298]]
As noted, under the original HHVBP Model, a minimum of eight HHAs
is required for each size cohort. For the expanded HHVBP Model, we
proposed to establish cohorts prospectively and with sufficient HHA
counts to prevent the need to combine multiple cohorts retrospectively.
We proposed to provide HHAs with their 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 estimated 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 21, 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 proposed to use cohorts based
on all HHAs nationwide, rather than by State as under the original
Model. Referencing the CY 2019 data in Table 21, 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 smaller-volume HHAs would not receive a score on the
HHCAHPS survey measures, which were proposed to account for 30 percent
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 stated that 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 stated in the proposed rule that 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
stated that 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 stated that 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 noted 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 proposed 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
proposed to codify this policy at Sec. 484.370, and to codify the
proposed definitions of smaller-volume cohort and larger-volume cohort
at Sec. 484.345. Under this proposal, HHAs currently participating in
the original HHVBP Model would no longer compete within just their
State. We also requested comment on the alternative approach of
applying State/territory-based cohorts only, without volume-based
cohorts.
We sought public comment on these proposals. We summarize in this
section of this rule the comments received and provide our responses.
Comment: Most commenters supported the use of State-based rather
than national cohorts in order to preserve the geographical differences
in quality benchmarks, which they contend result from variation in home
health utilization and other differences across regions. They expressed
concern that not using State-based cohorts will significantly shift
home health payments across State lines, leading to shortages of
necessary home health services in certain areas.
Response: We thank commenters for their comments on selection of
the appropriate cohorts to compare HHAs. We do not have evidence that
suggests that moving to national small- and large-volume cohorts would
significantly redistribute resources between states. We refer readers
to Table 43 of this final rule for an analysis of expected shifts in
FFS expenditures, as represented by the average FFS payment adjustments
for small- and large-volume HHAs in each of the States, territories,
and the District of Columbia, simulated with the proposed national
size-based cohorts using CY 2019 data and a maximum adjustment of
5 percent. We note that when the small- and large-volume
HHAs in each of the States, territories, and the District of Columbia
are combined, the average payment adjustment for the majority of
States, territories, and the District of Columbia is within 1 percent, with none exceeding 2 percent.
Furthermore, as discussed in the proposed rule, using the State-based
cohorts could potentially lead to an insufficient count of HHAs in 11
States, territories, and the District of Columbia. It is not apparent
that clear similarities exist between those States, territories, or the
District of Columbia with less than 20 HHAs in a cohort to support
grouping them for competition based solely on their lower HHA counts,
nor do we believe excluding these States, territories, or the District
of Columbia would be consistent with the goal of including all eligible
HHAs nationwide in the expanded Model.
Comment: Several commenters expressed concern that using national
rather than State-based cohorts would result in a shifting of resources
away from geographic areas with a higher burden of social risk factors
and toward areas with less social risk factors.
Response: We thank the commenters for sharing this concern. The
commenters' concern appears to assume that quality measure scores and
payments would be lower in areas with a higher burden of social risk
factors.
[[Page 62299]]
Table 41 in the proposed rule (86 FR 35996) demonstrates, however, that
simulating the proposed national cohorts with CY 2019 data, a high
percentage of dually eligible beneficiaries is associated with a higher
average payment adjustment under the expanded Model. This association
supports that use of national, volume-based cohorts would not
disadvantage those HHAs that care for beneficiaries with more
significant social risk factors. As noted previously, we also refer
readers to Table 43 of this final rule for an analysis of the shifts of
expenditures, as represented by the average payment adjustments for
small- and large-volume HHAs in each of the States, territories, and
the District of Columbia, simulated with the proposed national size-
based cohorts using 2019 data and a maximum adjustment of 5
percent. When the small- and large-volume HHAs in each of the States,
territories, and the District of Columbia are combined, the average
payment adjustment for the majority of States, territories, and the
District of Columbia is within 1 percent, with none
exceeding 2 percent. We welcome further feedback or
analysis on this issue from the public.
Comment: A commenter, on the other hand, strongly supported using
national cohorts, as proposed, stating that Medicare is a national
program and beneficiaries should have the same expectations for high-
quality care, regardless of which state they live in.
Response: We thank the commenter for this feedback. We agree that
since Medicare is a national program, all beneficiaries should have the
same expectations for high-quality care. As discussed previously, we
believe the use of national cohorts for purposes of the expanded Model
would allow for competition among HHAs across similar measures while
also providing sufficient numbers of HHAs in each cohort. This is also
consistent with value-based purchasing programs and the Home Health
Compare star ratings.
Comment: Other commenters requested that HHAs in States that did
not compete on quality in the original Model not be compared to the
same standard as HHAs in the original nine States, because they have
only been subject to publicly reporting of the measures, without
payment adjustments, over the past 5 years.
Response: We agree that HHAs in the 9 original Model States may
have more knowledge about the expanded Model, given many of these HHAs
have participated in the original HHVBP Model since 2016. However, as
discussed in section III.A.3.a of this final rule, after consideration
of the comments received, we are delaying implementation of payment
adjustments for 1 year, with CY 2023 serving as the first performance
year and CY 2025 serving as the first payment year, in order to provide
all HHAs with additional time to become familiar with and gain
experience with the expanded Model. We further note, as stated in
section XI.8.F.2 of the proposed rule and this final rule, based on our
analysis of the State-level impacts and using CY 2019 data to simulate
payment adjustments, we did 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 of using the national,
volume-based cohorts.
Final Decision: After considering the public comments received on
the cohorts for model expansion, we are finalizing the use of national,
volume-based cohorts in setting payment adjustments under the expanded
Model, as proposed, and are also finalizing to codify this policy at
Sec. 484.370. We are also finalizing the proposed definitions of
smaller-volume cohort and larger-volume cohort at Sec. 484.345.
Consistent with the original HHVBP Model, CMS will assess whether an
HHA qualifies for the smaller-volume cohort based on the volume of
unique patients eligible to submit the HHCAHPS survey in the prior
calendar year.
5. Payment Adjustment Percentage and Performance Assessment and Payment
Adjustment Periods
a. 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 proposed that the maximum payment adjustment, upward
or downward, would be 5 percent. We stated that 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. We proposed that 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 stated in the proposed rule that 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 solicited public comment on the proposed payment adjustment
percentage. We summarize in this section of this rule the comments
received on the proposed payment adjustment percentage and provide our
responses.
Comment: Some commenters expressed concern that the proposed 5
percent maximum payment adjustment was too high for the first year of
the expanded model. A few commenters suggested a 3 percent maximum
payment adjustment to match the first payment adjustment year of the
original model, other commenters suggested a 2 percent maximum payment
adjustment to match Hospital Value Based Purchasing, and others
suggested a 1 percent maximum payment adjustment. A few commenters
suggested starting the expanded model at a lower percentage and slowly
increasing the maximum payment adjustment over time.
Response: We appreciate commenters sharing their concerns about the
potential for a 5 percent payment adjustment. Under the payment
adjustment methodology described in III.A.8 of this rule, we anticipate
that most HHAs will receive a positive or negative payment adjustment
smaller than the proposed 5 percent maximum adjustment. We reviewed the
payment distribution under the original HHVBP Model for CY 2019, the
second payment adjustment year, when the maximum payment adjustment was
5 percent. During that year, 93.2 percent of the HHAs participating in
the original HHVBP Model received a payment adjustment ranging from -3
percent to +3 percent and 98.8 percent of the HHAs received a payment
adjustment ranging from -4 percent to +4 percent. Using simulated data
with national cohorts, we found 72 percent of HHAs would have received
a payment adjustment ranging from -3 percent to +3 percent and 85
percent of HHAs would have received a payment adjustment ranging from -
4 percent to +4 percent. In the original HHVBP model, we increased the
maximum payment adjustment each year to allow HHAs the opportunity to
become familiar with the operation of the model before applying higher
percentage
[[Page 62300]]
payment adjustments in later years, including a maximum payment
adjustment of 5 percent for the second payment year. In this final
rule, we are delaying the first payment adjustment year to provide HHAs
with learning support in advance of the application of payment
adjustments under the expanded Model. As discussed in the proposed
rule, we will continue to evaluate the 5 percent payment adjustment and
consider any changes for future rule making.
Final Decision: After consideration of the public comments, we are
finalizing the payment adjustment as proposed. As discussed previously,
we are also finalizing a delay in the start of payment adjustments
under the expanded Model, such that CY 2025 would be the first payment
year, with payment adjustments based on performance in CY 2023.
b. 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 proposed 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 stated in the proposed rule that we may propose to update the
baseline year for subsequent years of the expanded Model through future
rulemaking. We stated that 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 solicited public comment on the proposed baseline year for the
expanded Model. We summarize in this section of this rule the comments
received on the proposed baseline year and provide our responses.
Comment: A few commenters supported using CY 2019 as the baseline
year. Other commenters cautioned against using 2019 as a baseline year
because they asserted it inherently means comparing pre-COVID-19, pre-
Patient Driven Grouping Model (PDGM) performance to performance in a
very different environment. A commenter recommended CMS provide
clarification on subsequent baseline periods in future years of the
Model in a timely fashion so that HHAs have as much advance notice as
possible. The commenter also encouraged CMS to eventually automatically
advance the baseline period of the model by one year as each
performance year is advanced, like other value-based programs.
Response: We proposed using CY 2019 as the baseline year, as
opposed to CY 2020, due to the potentially de-stabilizing effects of
the PHE on the CY 2020 data and because it was the most recent full
year of data available prior to CY 2020 to provide HHAs with
achievement thresholds and benchmarks as soon as administratively
feasible and prior to the start or soon after the start of the
applicable performance year. As noted later in this final rule, the
PDGM is a case-mix adjustment model intended to pay for services more
accurately and we believe the HHVBP Model can continue unchanged when
HHA periods of care are paid according to the case-mix adjustments of
the PDGM. We further believe that the payment change should not affect
measure scoring between the baseline year and the performance years.
However, CMS may consider conducting analyses of the impact of using
various baseline periods, and would address any changes to the baseline
period in future rulemaking. We appreciate the commenter's suggestion
to eventually automatically advance the baseline period by one year as
each performance year is advanced in an effort to align with other
value-based programs and will take it under consideration.
Final Decision: After consideration of comments received, we are
finalizing our proposal to use CY 2019 (January 1, 2019 through
December 31, 2019) as the baseline year. As discussed previously, we
are also finalizing to delay the first performance and payment year
under the expanded Model. Accordingly, the baseline year would be CY
2019 for the CY 2023 performance year/CY 2025 payment year and
subsequent years; however, we may conduct analyses of the impact of
using various baseline periods and consider any changes for future
rulemaking.
(2) New HHAs
As noted previously, we generally proposed 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 proposed 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 proposed 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 proposed 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 22 shows
the proposed HHA baseline, performance and payment years based on the
HHA's Medicare-certification date through December 31, 2021.
[[Page 62301]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.036
We also proposed to codify our proposal on new HHAs at Sec.
484.350. We solicited public comment on these proposals.
Final Decision: We did not receive any comments on our proposals
regarding new HHAs and are finalizing our proposal that for new HHAs,
specifically those HHAs that are certified by Medicare on or after
January 1, 2019, 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 are finalizing that new HHAs would begin
competing under the expanded HHVBP Model in the first full calendar
year (beginning with CY 2023) following the full calendar year baseline
year. For example, under this final policy, all HHAs certified for
participation in Medicare before January 1, 2022, would have their CY
2023 performance assessed and would be eligible for a CY 2025 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 23
shows the finalized HHA baseline, performance and payment years based
on the HHA's Medicare-certification date through December 31, 2021.
[GRAPHIC] [TIFF OMITTED] TR09NO21.037
We are also finalizing our proposed codification of this policy at
Sec. 484.350 with modification to reflect the one-year delay in the
first performance year from CY 2022 to CY 2023. Specifically, we are
adding ``(beginning with CY 2023)'' to reflect that for new HHAs
certified by Medicare on or after January 1, 2019, the first
performance year is the first full calendar year (beginning with CY
2023) following the baseline year.
6. Quality Measures
a. General Considerations Used for the Selection of Quality Measures
for the Expanded HHVBP Model
We stated in the proposed rule that we plan to apply, to the extent
possible, principles from CMS' Meaningful Measures Initiative \18\ in
selecting the applicable measures as defined at Sec. 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
[[Page 62302]]
quality of care; Care coordination; Population/community health;
efficiency and cost reduction; safety; and, Patient and caregiver-
centered experience.
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\18\ https://www.cms.gov/meaningful-measures-20-moving-measure-reduction-modernization.
\19\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
\20\ For 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.
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We stated that 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 stated in the proposed rule that we intend to
consider new measures for inclusion in subsequent years of the expanded
HHVBP Model through future rulemaking. We stated that 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 authority under
section 1115A of the Act 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 stated that 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 reiterated that we would propose any new
measures through future rulemaking.
b. Initial Measure Set for the Expanded Model
We proposed 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. (As
discussed in the preceding section, we are finalizing CY 2023 as the
first performance year, and CY 2025 as the first payment year, under
the expanded Model.) The proposed measures were also used under the
original Model (83 FR 56533). However, we noted that no ``New
Measures'' as defined in the original Model (80 FR 68674) were 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 noted that any
future additional measures proposed for the expanded HHVBP Model would
not be considered ``New Measures'' as used in the original Model.
We proposed the measures as detailed in Tables 26 and 27 of the
proposed rule (86 FR 35923 through 35926) 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 stated in the proposed rule
that 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 value-based incentives
provided under the expanded Model. Further, we stated that 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 of the proposed rule (86 FR 35923 through 35926): Claims-
based, 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 final 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 final rule).
(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 takes 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 M items. These six M items and
their short name are as follows:
Grooming (M1800)
Upper Body Dressing (M1810)
Lower Body Dressing (M1820)
Bathing (M1830)
Toileting Hygiene (M1845)
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 M items and their short name are as follows:
Toilet Transferring (M1840)
Bed Transferring (M1850)
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/hhs-guidance-documents/hhvbp%20computing%20the%20hhvbp%20composite%20measures.pdf.
We stated in our discussion of the proposed TNC measures in the
proposed rule that 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. In this final rule, we acknowledge that use of
the term ``improvement'' to describe the TNC measures does not take
into account the risk adjustment
[[Page 62303]]
methodology used to calculate these measures or that the structure of
the measures also addresses how effectively a HHA can limit any decline
of the patient because it implies that the TNC measures would only
measure an increase in a patient's functional status, and we have
revised our discussion of these proposed measures in this final rule
accordingly. The risk adjustment methodology for these two measures is
designed to take into account instances where the goal of home health
care is to maintain the patient's current condition or to prevent or
slow further deterioration of the patient's condition by including risk
factors for a wide variety of beneficiary-level characteristics,
including age, risk for hospitalization, 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
without cognitive impairment. In effect, the self-care change 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/hhs-guidance-documents/hhvbp%20technical%20specification%20resource%20for%20composite%20outcome%20measures_4.pdf. As discussed in our response to comments in this
section of this rule, the technical specifications for the composite
measures have been updated and the updated specifications can be found
in the downloads section on the CMS website.\21\ 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).
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\21\ https://innovation.cms.gov/innovation-models/home-health-value-based-purchasing-model.
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We noted in the proposed rule 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 HH PPS 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 stated in
the proposed rule that 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[supreg] 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.\22\
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\22\ https://homehealthcahps.org/General-Information/About-Home-Health-Care-CAHPS-Survey.
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We note that the HHCAHPS survey is also part of the HH QRP
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://homehealthcahps.org/.
We invited public comment on our proposed measure set. We summarize
in this section of this rule the comments and provide our responses.
Comments on the Measure Set Generally
Comment: A commenter encouraged CMS to include more measures in a
future nationwide HHVBP, including (but not limited to) measures of
outcomes, safety, and caregiver engagement. Another commenter supported
the proposed measure set saying the quality measures reflect functional
independence and agreed with CMS that using measures that are outcome
focused and risk adjusted is the most useful to stakeholders to
demonstrate value. The commenter stated that process-based measures are
of little value and that measures should be a balance of health
outcomes, utilization, and patient satisfaction.
Response: We thank the commenters for their recommendations and
feedback on the proposed measure set. We agree that outcome,
utilization and patient satisfaction measures are good indicators of
value-based care and therefore have proposed to include these measure
types in the expanded HHVBP Model. We believe the proposed measure set
encourages HHAs to provide care that supports patients who wish to
remain in their home whether the patient's goal is functional
independence, stabilization or to prevent further decline. CMS will
continue to monitor measure performance and to seek stakeholder input
and may propose measure modification in future rulemaking.
Comment: Commenters supported the removal of the three ``New
Measures'' from the measure set under HHVBP Model expansion.
Response: We thank the commenters for their support.
Comment: Commenters stated that CMS should establish a Technical
Expert Panel (TEP) to evaluate the proposed HHVBP measures to ensure
that the measures appropriately consider the full scope of the patient
population served with the home health benefit, particularly patients
not likely to experience condition improvement. Another commenter
asserted that there
[[Page 62304]]
is no evidence that CMS has sought out experts who can determine how to
devise meaningful and inclusive measurements, and that there must be
measurement experts CMS can engage who can determine how to measure
everyone. The commenter further asserted that CMS should have located
or developed appropriate quality measurements during the implementation
period of the original HHVBP Model or for the Quality Reporting
Program.
Response: As described in the CY 2019 final rule (83 FR 56528-
56529), CMS received input from a TEP on measure set modifications for
the measures under the original Model. As under the original Model, and
noted in section III.A.6.5 of this final rule, we plan to continue to
seek input on the measure set, including from stakeholders in relevant
fields such as clinicians, statisticians, quality improvement, and
methodologists, and to monitor quality measure performance to inform
potential measure set changes under the expanded Model. We further note
that the majority of the measures in the proposed expanded Model
measure set were used since the implementation of the original Model in
CY 2016 and that the majority of the measures overlap with the HH QRP,
except for the TNC change measures.
Comment: A commenter stated that home health payment reform must be
implemented in a way that maintains beneficiary access to care and
ensures beneficiaries receive necessary and appropriate care. A
commenter stated that excessively stringent model payment design may
increase Medicare savings but simultaneously cause HHAs to leave the
market, particularly in rural and other underserved areas. The
commenter stated that HHAs may also respond to payment pressure by
avoiding beneficiaries whose care is perceived as potentially
jeopardizing HHAs' performance scores, when those beneficiaries may be
the ones having the greatest clinical needs for home health services.
Response: We agree that home health payment reform, specifically
for HHVBP, should be implemented so that beneficiaries maintain access
to care and receive necessary and appropriate care. We disagree with
the comments that the HHVBP model payment design may cause HHAs to
leave the market. As previously noted, evaluation findings showed that
implementation of the original HHVBP Model did not adversely impact
home health utilization, market entry and exit.
Comment: A commenter raised concerns that the measure set should
score a small set of outcomes, patient experience, and value (for
example, resource use) measures that are not unduly burdensome for
providers to report. The commenter suggested that scores could be based
on three claims-based measures of quality and resource use: All-
condition hospitalizations with the HH stay, successful discharge to
the community, and Medicare spending per beneficiary.
Response: The proposed measure set for the expanded HHVBP Model
includes measures that are currently already reported by HHAs and
therefore we do not believe these measures would be unduly burdensome
for HHAs to report. As discussed in the proposed rule, in evaluating
whether to augment the initial measure set, we would consider the
potential burden on HHAs to report measure data that is not already
collected through existing quality measure data reporting systems. We
thank the commenter for their suggestion to score HHAs on three claims-
based measures. We note that the HHVBP expanded Model measure set was
developed to encourage HHAs to focus on quality, patient-centered care
and quality improvement across various focus areas, including those
which are not directly measured through claims-based measures, such as
patient experience. We further note that we did not propose the claims
measures described but we may consider the use of additional claims-
based measures in the expanded HHVBP Model for future rulemaking.
Comment: Some commenters stated that quality measures are not
always under the control of the HHA. One example they provided is the
OASIS quality measure, Self-Management of Oral Medications, where
medication management could be done by an assisted living facility
rather than the HHA. Commenters requested that CMS take these types of
discrepancies into account so that the HHA is not penalized.
Response: We disagree with the commenters that HHAs serving
patients in an assisted living facility are at a disadvantage to
achieve a higher quality score in this area of measurement. We believe
that all HHAs must aim to provide high quality care and therefore
assess for and put into place care planning and coordination of
services, including the coordination on the management of oral
medications, to mitigate poor quality outcomes regardless of care
setting.
Comments Regarding Claims-Based Measures
Comment: A commenter stated CMS should consider how recent changes
to the payment system affect scoring some of the measures. The two
claims-based measures, Acute Care Hospitalizations (ACH) and Emergency
Department (ED) Use without Hospitalization, are measured during the
first 60 days of home health. They encourage CMS to consider how the
changes to the home health payment system from the 60-day unit under
the previous case-mix system (in CY 2019) to the 30-day unit under
Patient Driven Grouping Model (PDGM) (in CY 2020 and later) could
affect HHAs' scores on the ACH and ED use measures between the baseline
and performance years.
Response: The PDGM is a case-mix adjustment model intended to pay
for services more accurately We believe the HHVBP Model can continue
unchanged when HHA periods of care are paid according to the case-mix
adjustments of the PDGM. We may consider conducting analysis of the
effects on HHAs' scores for ACH and ED Use measures between the
baseline year and a performance year.
Comment: A commenter suggested using functional status as a risk
adjuster for the hospitalization measures in the HHVBP model.
Response: Currently, there is no risk adjuster on our proposed
claims measures. The proposed initial measure set for the expanded
HHVBP Model includes the ACH measure which does not have any functional
mobility elements. We thank the commenter for their suggestion and may
take into consideration as we move forward in the implementation of the
expanded HHVBP Model. We further note that we may make adjustments to
the risk adjustment methodology based upon the removal of measures,
changes to the assessment instrument, and diagnosis code changes.
Comments Regarding the OASIS-Based Measures
Comment: A commenter recommends that CMS replace the OASIS-based
Discharge to Community measure in the HHVBP proposed measure set with
the new, claims-based Discharged to Community measure used under HH
QRP. The commenter stated that maintaining both measures is confusing
to HHAs as the measures have similar names but are calculated
differently and that the new claims-based measure provides a more
accurate score.
Response: We thank the commenter for their recommendation.
Additional
[[Page 62305]]
analysis is needed to evaluate the use of the claims-based Discharge to
Community Measure used under the HH QRP in place of the OASIS-based
measure. We will continue to monitor quality measure performance under
expansion and will consider any potential measure modifications for
future rulemaking.
Comment: A commenter requested more detail on what changed in the
updated risk adjustment methodology as it relates to the TNC measures.
Response: We have updated the risk adjustment methodology as it
relates to the TNC measures, which is available on the HHVBP Model
Expansion webpage.\23\ CMS made optional OASIS items (M1030, M1242,
M2030, and M2200) collected at the start or resumption of a care that
were used in the risk adjustment and the update posted on the HH QRP
website.\24\ Since voluntary items may be missing for some home health
quality episodes, these four voluntary items were removed from the risk
adjustment model update effective for episodes of care beginning 1/1/
2021 and posted on the HH QRP website, as noted above. We note that the
updated methodology, posted on the HHVBP Model Expansion webpage noted
above, is applicable to episodes of care for the CY 2022 pre-
implementation year, however as noted previously in this rule, HHAs
will not be assessed on their performance of the TNC measures in CY
2022 that are based on the updated risk adjustment methodology. We note
that the next update of the risk adjustment models is planned for the
release of OASIS E which would apply to episodes of care beginning 1/1/
2023, the first performance year under the expanded HHVBP Model. That
is, as CY 2023 is the first performance year under the expanded Model,
HHAs would be assessed on their performance on the TNC measures based
on the updated risk adjusted methodology for episodes of care that
would begin 1/1/2023. We further note that, during that update of the
methodology that would be effective with episodes of care beginning 1/
1/2023 and for which HHA's performance will be assessed, the risk
adjustment models will be based on refreshed data and all risk factors
will be re-tested for inclusion.
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\23\ https://innovation.cms.gov/innovation-models/home-health-value-based-purchasing-model.
\24\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Home-Health-Quality-Measures in a file titled Risk Adjustment Technical Specifications.
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Comment: A commenter strongly supported the use of outcomes
measures on functional status, such as the two OASIS composite measures
(TNC Change in Mobility and TNC Change in Self-Care), stating that a
patient's functional status is inextricably related to their ability to
remain in a community setting and avoid unnecessary utilization of
health care services. The commenter stated that it appreciates that
these measures are broadly risk-adjusted to recognize patients with
inherently limited goals for improvement, which can help account for
differences in patient type that may affect an HHA's performance on
certain measures. The commenter, however, recommended CMS consider
whether additional risk adjustment would better account for patient
differences, specifically for those with more limited potential for
functional improvement.
Response: We thank the commenter for their support of the use of
outcome measures on functional status. We appreciate the commenter's
suggestion regarding additional risk adjustment to better account for
patients with more limited potential for functional improvement and
refer readers to our detailed response, discussed later in this
section, on the risk adjusted methodology for the TNC measures.
Comment: Commenters expressed concern that the OASIS measures have
the potential to reward non-legitimate quality improvement, because
HHAs record and report functional assessment data through the OASIS
assessment, and this information affects payments for HHAs and the
calculation of certain quality metrics. The commenters asserted that
providers have an incentive to report the information in ways that
raise payments and appear to improve performance, resulting in
questionable value for payment, quality measurement, and care planning.
A commenter agreed that improving a patient's functional ability is a
goal of home health care, but urged CMS not to include these OASIS-
based measures of function (for example, TNC Change in Self-Care and
TNC Change in Mobility) in the expanded HHVBP Model until their
accuracy is improved.
Response: With regard to concern that the OASIS measures may have
the potential to reward non-legitimate quality improvement or that the
measures may incentivize providers to report their OASIS assessments in
ways that raise payments, we believe that the OASIS-based measures
yield reliable information for assessing HHAs' quality performance and
capture important information about beneficiaries' function based on
reliability testing.\25\ Most OASIS items achieve moderate to near
perfect reliability based on reported Kappa values. With regard to the
comment that CMS should not include the TNC measures in HHVBP until
their accuracy is improved, we refer readers to our detailed response,
that follows this response, on the TNC measures including their
methodologies. We believe that our analysis of the TNC measures
supports that these measures capture a change in a patient's status for
the beneficiary population that may not have goals of improvement. We
will continue, as with all measures in the measure set, to evaluate the
benefit of the measure as the expanded Model progresses.
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\25\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-Field-Test-Summary-Report_02-2018.pdf.
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Comment: We received many comments about including stabilization/
maintenance measures in the expanded Model and the proposed TNC
measures. A commenter suggested that there be a modified risk
adjustment that accounts for patients in palliative care population
(for example, discharge to hospice care). Commenters suggest that a
stronger risk adjustment model is needed for HHVBP to recognize that
some home health agencies care for a much sicker and more complex
population than others so agencies can be compared fairly and to ensure
that incentives are aligned to care for patients with complex health
and social determinant needs. Alternatively, commenters expressed that
CMS could remove all patients with maintenance goals from HHVBP until
all measures, incentives, and disincentives equally reflect their needs
and qualifications for Medicare coverage as for those beneficiaries who
can improve. The commenters suggest that improvement measures coupled
with the higher weights assigned to the hospitalization and emergency
department use claims-based measures may serve to disincentivize home
health agencies from accepting into service Medicare beneficiaries that
have chronic and/or unstable conditions or that the proposed measure
set would negatively impact beneficiary access because HHAs may choose
to care for patients who can show improvement in order to maximize
their payment adjustment. Commenters stated that expansion should be
temporarily halted in order to refine the methodology of how
improvement is to be calculated to sufficiently account for patient
populations whose appropriate goal may be to slow or temporarily halt
[[Page 62306]]
functional decline, but who cannot reasonably be expected to make major
improvements in activities of daily life (ADL) scores. Some commenters
expressed concern that the proposed measures focus largely on
improvement and should include stabilization and maintenance measures
as well. Commenters asserted that the measure set's improvement
standards are relied upon too heavily, which will negatively impact
HHAs with chronic care, palliative care, and end of life patient
populations, and that CMS's current risk adjuster does not account for
these differences sufficiently. A commenter asserted that since the
HHVBP Model was first proposed in 2015, quality measures discriminate
against Medicare beneficiaries with longer-term, chronic conditions who
require skilled care but are not expected to improve--patients covered
by the Jimmo class action settlement and provided an example of a
patient that it asserted would be harmed by expanding HHVBP. The
commenter asserted that the proposed TNC Self-Care and TNC Mobility
composite measures are not appropriate or adequate for beneficiaries
who are not able to improve. The commenter believes that the
methodology for the TNC measures does not allow agencies to benefit
from providing care to beneficiaries who are not expected to improve
regardless of how high the quality of care.
Response: We believe the goals of home health care are to provide
restorative care when improvement is expected, maintain function and
health status if improvement is not expected, slow the rate of
functional decline to avoid institutionalization in an acute or post-
acute care setting, and/or facilitate transition to end-of-life care,
when appropriate. We remind commenters that the structure of the home
health benefit requires a multidisciplinary approach of not only
therapy services, but skilled nursing, home health aide, and medical
social services. The TNC measures, as previously stated, are not
improvement measures but rather, they measure the change in function in
either direction, both positive and negative.
The TNC measures, in the proposed measure set, capture any risk-
adjusted change (negative and positive). In general, a positive change
between Start of Care (SOC)/Resumption of Care (ROC) and End of Care
(EOC) assessment increases the measure values more than no change or a
negative change. But the risk adjustment methodology for these measures
is designed to level the ``playing field'' based on underlying risk
factors. We also have exclusions in place for nonresponsive patients.
Relative to the functional improvement measures in the initial HHVBP
measure set, the TNC measures reward HHAs that help patients maintain
or prevent excessive decline in their functional abilities overall. The
TNC measure is a composite of changes, not improvement. We provide an
example to help demonstrate how HHAs would not be dis-incentivized to
care for beneficiaries who are not expected to improve, demonstrating
how the risk-adjustment model recalibrates the scores for HHAs caring
for beneficiaries with more complex medical needs relative to HHAs
caring for less complex beneficiaries.
Risk Adjustment for Proposed TNC Measures
Risk adjustment is necessary to account for differences in patient
case mix among different HHAs that affect performance on outcome
measures. That is, age and pre-existing conditions impact how patients
perform on outcome measures and risk adjustment accounts for the
differing types of patients served by HHAs and enables comparison
across HHAs. These same risk adjustment methods are employed in other
quality measures, such as the hospital-based mortality measures, to
prevent providers from avoiding the sickest patients and preferencing
the healthiest.
The general formula for risk adjustment of OASIS outcomes measure
is as follows:
OutcomeRA = (ObservedHHA-PredictedHHA) + National
Where
OutcomeRA is the HHA's risk adjusted outcome measure
value,
ObservedHHA is the HHA's average observed values for the
outcome measure,
PredictedHHA is the HHA's average predicted values for
the outcome. Predicted values are obtained from a regression model
using a set of risk factors, and
National is the average predicted value across all episodes in the
nation.
An HHA's risk adjusted measure value is calculated by averaging the
HHA observed measure value across all its patients and subtracting the
HHA's average predicted measure value across all its patients. To
standardize the result, the national measure value is then added to
obtain the risk adjusted outcome measure for the HHA.
The following example demonstrates how the formula, as previously
discussed, would work for a hypothetical patient with the following
risk factors, as referenced by a commenter:
Age 56
Diagnosis of multiple sclerosis
Use of catheter
Table 24 shows the risk adjustment coefficients on the selected
risk factors for OASIS-based measures in the proposed measure set for
the HHVBP expansion for this hypothetical beneficiary. The presence of
these risk factors is almost always associated with lower predicted
measure values for the OASIS-based outcome measures used in the
proposed measure set for HHVBP expansion, as evidenced by the negative
signs on the coefficients shown in this table.
[[Page 62307]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.038
Negative coefficients lower the predicted value for a beneficiary
with these characteristics and positive coefficients increase the
predicted value. For each of the measures, summing the coefficients on
the three risk factors shows that the presence of all three risk
factors contributes negatively to the predicted value for those
beneficiaries with the risk factors for all five measures in Table 24.
Using the risk adjustment formula as previously discussed, the lower
predicted values for these episodes would contribute to boosting the
risk adjusted measure value if all other risk adjustment variables are
equal across HHAs.
For illustrative purposes, imagine that the national average TNC
Mobility score is 0.73 and a particular HHA has an observed score of
0.60. If all the HHA's patients had the three, previously discussed,
risk factors (and no others), the HHA's risk adjusted TNC Mobility
score would be 0.60--0.45 \26\ + 0.73 = 0.88. This score (0.88) is
higher than the national score even though the observed value is lower
than the national score. Note that this is purely hypothetical--actual
episodes for an HHA would trigger multiple different risk factors
(there are over a hundred) and the predicted value would be summed over
the coefficients for all of these risk factors.
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\26\ To calculate the 0.45, we sum the coefficients in the table
above with the constant estimated from the updated risk adjustment
model (https://www.innovation.cms.gov/innovation-models/home-health-value-based-purchasing-model) and apply the logistic formula (see
Chapter 6 of https://www.cms.gov/files/document/hh-qrp-qm-users-manual-v1-addendum.pdf).
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Based on the risk adjustment formula, the lower the average
predicted measure value is for an HHA, the higher the HHA's risk
adjusted outcome score. That is, patients with multiple risk factors
associated with lower measure performance will have a lower predicted
value than patients without those risk factors. The lower predicted
value will increase the risk-adjusted measure score.
We believe that our analysis of the TNC measures supports that
these measures capture a change in a patient's status for the
beneficiary population that may not have goals of improvement. We will
continue, as with all measures in the measure set, to evaluate the
benefit of the measures as the Model progresses.
Comment: A commenter suggested that CMS consider including a falls
prevention measure as key patient safety data necessary for a
comprehensive HHVBP model. The commenter suggested, for example, that
NQF 0101/CMIT 1247 Falls: Screening, Risk-Assessment, and Plan of Care
to Prevent Future Falls could be considered. The commenter stated that
a falls prevention measure would help to ensure that HHAs are
addressing risks and planning for interventions to minimize patient
falls in the home, which can lead to greatly increased cost if a
patient requires an emergency room visit, hospitalization, or other
care to treat any injuries. Another commenter suggested that because
family caregivers often play an important role in caring for the
beneficiary, CMS consider adopting a measure for use in both the HHVBP
model and HH QRP program that addresses HHAs documenting whether the
beneficiary has a family caregiver and provided additional factors for
the HHA to collect surrounding a beneficiary's family caregiver.
Response: We thank the commenters for their recommendations and we
may consider these measures for inclusion in the expanded Model's
measure set in a future year.
Comments Regarding the HHCAHPS Survey Measure
Comment: A commenter was not in favor of the overall quality rating
proposed as a HHCAHPS measure as they believe it is not specific or
necessarily actionable for improvement opportunities.
Response: We believe that patient experience is an important way to
assess quality of care. The HHVBP expanded Model measure set was
developed to encompass a home health episode of care from intake
through to the patient experience survey encouraging HHAs to focus on
quality, patient-centered care and quality improvement across various
focus areas, including those which are not directly measured through
the claims-based measures, such as patient experience.
Comment: A commenter supported HHCAHPS as part of the expanded
Model's measure set. Another commenter stated that since patient
experience is a key measure of a provider's quality, the HHVBP Model
should continue to score HHCAHPS measures and that the measure set
should be revised as other measures become available.
Response: We thank the commenters for their feedback. We agree that
the HHCAHPS measure is a key measure of a provider's quality of care
provided. We will continue to monitor quality measure performance as we
consider any potential measure set changes for future rulemaking.
Final Decision: After consideration of comments received, we are
finalizing the measure set as proposed effective with the CY 2022 pre-
implementation year and subsequent years. We are also
[[Page 62308]]
finalizing our proposed regulation text at Sec. 484.355(a)(1) with
modification to reflect that an HHA must submit data on the specified
measures under the expanded HHVBP model for both the pre-implementation
year and each performance year. As discussed in section III.A,3.a of
this final rule, we are finalizing CY 2025 as the first payment year,
instead of CY 2024. CY 2022 will be a pre-implementation year to allow
all HHAs time to prepare and learn about the HHVBP expanded Model for
successful implementation. Quality measure data collected during CY
2022 will not be assessed for purposes of a payment adjustment under
the expanded HHVBP Model; that is, HHAs will incur zero percent (0%)
payment risk based upon CY 2022 performance. CY 2023 will be the first
performance year, beginning January 1, 2023; CY 2025 will be the first
payment year. Table 25 sets forth the finalized measure set for the
expanded HHVBP Model. We note that in Table 26 of the proposed rule,
the Measure Steward and Identifier for the Discharged to Community
measure was NA and NA, respectively. In Table 25, the finalized measure
set for the expanded Model, the Measure Steward and the Identifier is
updated to CMS and NQF 3477, respectively.
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[GRAPHIC] [TIFF OMITTED] TR09NO21.039
[[Page 62309]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.040
Table 26 provides more granular detail on the elements of the Home
Health Care Consumer Assessment of Healthcare Providers and Systems
(HHCAHPS) Survey measure.
[[Page 62310]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.041
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c. Measure Modifications
During the expanded Model, we will monitor the quality measures for
lessons learned and address any needed adjustments or modifications to
the expanded Model measure set.
(1) Substantive vs. Non-Substantive Changes Policy
Updates to measures may result from various sources including, for
example, measure stewards and owners, new clinical guidelines, a public
health
[[Page 62311]]
emergency, CMS-identified, a technical expert panel (TEP), or NQF. We
stated in the proposed rule that 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 stated in the proposed rule that 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
non-substantive 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 proposed 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 also proposed 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 stated
that 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 invited public comment on our proposal. We summarize in this
section of this rule the comments received and provide our responses.
Comment: A commenter suggested that ongoing modifications to the
HHVBP expanded model (for example, scoring methodology, quality measure
inclusion, risk adjustment methodology) are necessary to ensure the
expanded model accurately and appropriately reflects the value of
services delivered and the beneficiary populations cared for.
Response: CMS will continue to evaluate and monitor the expanded
HHVBP Model for potential modifications to ensure the expanded model
accurately and appropriately reflects the value of services delivered
and the beneficiary populations cared for.
Final Decision: After consideration of comments received, we are
finalizing our proposal as proposed.
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
the proposed rule, for greater transparency, we proposed factors we
would consider in proposing to remove a measure as well as a policy for
when immediate suspension is necessary.
(1) Removal Factors
We proposed to generally use the following 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.
[[Page 62312]]
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.
We proposed that we would remove measures based on Factor 8 on a
case-by-case basis. For example, we may decide to retain a measure that
is burdensome for HHAs to report if we conclude that the benefit to
beneficiaries is so high that it justifies the reporting burden. 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 case-by-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 necessitate 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 solicited public comment on our proposals.
Final Decision: We did not receive any comments on our proposal and
are finalizing the measure removal factors as proposed.
(2) Measure Suspension Policy
We stated in the proposed rule that removal of an expanded HHVBP
Model measure would take place through notice and comment rulemaking as
proposed in the preceding section unless we determine that a measure is
causing concern for patient safety or harm. We proposed 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 solicited public comment on our proposal.
Final Decision: We did not receive any comments on our proposal and
are finalizing the measure suspension policy as proposed.
e. Future Topics or Measure Considerations
(1) Consideration To Align or Remove Measures With the HH QRP
In section IV.C. of the proposed rule, CMS proposed 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)
measure beginning with the CY 2023 under the HH QRP. (As discussed in
section IV.C of this final rule, CMS is finalizing its proposal to
replace the ACH and ED Use measures with the PPH measure for the HH QRP
measure set beginning with CY 2023.) We noted in the proposed rule that
while both the ACH and ED Use measure were being proposed for removal
under the HH QRP, these measures were being proposed for inclusion in
the expanded HHVBP Model beginning with the CY 2022 performance year.
We solicited 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 noted that any measure removals would be proposed in future
notice and comment rulemaking.
We requested public feedback on this future consideration. We
summarize in this section of this rule the feedback received and
provide our responses.
Comment: Commenters recommended that the HHVBP measure set align to
measures of the HH QRP. Another commenter suggested that CMS move to
align the included measures with the Star Ratings and other quality
reporting activities. Another commenter stated that by bringing
consistency to tracked outcomes across the HH QRP, Star Ratings, and
HHVBP, CMS will minimize the difficulty of beneficiaries and payers to
make comparative assessment of provider quality while also streamlining
home health providers' data capture and reporting processes.
Response: We thank the commenters for their suggestions. We note
that the proposed measure set for the expanded HHVBP Model generally
aligns with the HH QRP. We will take into consideration opportunities
for further alignment, including with respect to the claims-based
measures. If we consider adding new measures that require data that is
not already collected through existing quality measure data reporting
systems, we would propose that in future rulemaking being mindful of
provider burden.
Comment: Commenters expressed that they need at least one year to
become familiar with the Home Health Within-Stay Potentially
Preventable Hospitalization (PPH) measure, and to affect outcomes, if
needed, before including it in the HHVBP expanded Model measure set.
Response: We thank the commenters for their feedback and will take
into future consideration.
(2) Health Equity Considerations for the Expanded HHVBP Model
In section VIII.B. of the proposed rule, we included a Request for
Information on ways to close the health equity gap in post-acute care
quality reporting programs, including the HH QRP. In the proposed rule,
we referred 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 requested public
comment on ways in which we could incorporate health equity goals and
principles into the expanded HHVBP Model. Specifically, we sought
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.
In this section of this rule, we summarize comments received and
provide our responses.
[[Page 62313]]
Comment: A commenter stated that in an effort to prevent bias in
patient selection, it encouraged CMS to consider potential
stabilization measures, rather than sole reliance on improvement
measures. The commenter stated that this will continue to promote
access to care for individuals with chronic illness or limited ability
to improve, and is consistent with the renewed focus on health equity.
Another commenter generally supported health equity goals and
principles incorporated in the expanded HHVBP Model. The commenter
recommended CMS collect patient-level demographic information based on
segmented demographics (race, ethnicity, gender, etc.) on existing
measures, instead of creating new or more complex measures. The
commenter stated that should CMS move forward with adopting new health
equity measures, it recommended CMS include these measures in the HH
QRP prior to inclusion in the HHVBP Model.
Response: We thank the commenters for their feedback. As discussed
in section III.A.6.b of this final rule, we are finalizing the measure
set as proposed, which includes improvement, total normalized composite
change measures, utilization and patient experience measures. We refer
readers to our earlier detailed response in this section of the rule on
the TNC change measures, including the measure methodology, and why we
believe the measure set would not dis-incentivize HHAs from caring for
beneficiaries with chronic illness or limited ability to improve.
Health equity including access to care for all beneficiaries is a
priority. CMS will continue to monitor beneficiary access under the
HHVBP Model expansion.
Comment: A commenter recommended that outcomes measured in the HH
QRP and HHVBP Model be stratified by various patient populations to
determine how they are affected by Social Determinants of Health
(SDOH).
Response: We note that in section VIII.B of this final rule, we are
finalizing our proposal to revise compliance dates for HHAs under the
HH QRP. This policy includes the submission of certain standardized
patient assessment data, some of which address social determinants of
health (SDoH). These standardized patient assessment data, in part,
support efforts to evaluate health equity in a manner we believe is
consistent with the policy set out in Executive Order 13985 of January
20, 2021, entitled ``Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government'' (86 FR 7009).
We are working collaboratively with HH QRP to determine how data
collected on SDoHs under HH QRP could be part of the HHVBP Model
expansion in the future.
f. Measure Submissions--Form, Manner, and Timing
We proposed at Sec. 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 in the proposed rule and previously in this final rule,
the measures that we proposed and are finalizing for the expanded HHVBP
Model measure set would use data currently already reported by HHAs.
The measure set includes OASIS \27\ 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. As we stated in the proposed rule, 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 the
proposed rule and this final rule, in the future we may propose new
measures that may not otherwise already be collected or submitted by
HHAs.
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\27\ For detailed information on OASIS see the official CMS web
resource available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits.
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We solicited comment on our proposal.
As previously noted, we are finalizing our proposed regulation text
at Sec. 484.355 with modification to reflect that an HHA must submit
data on the specified measures under the expanded HHVBP model for both
the pre-implementation year and each performance year.
(1) Form, Manner, and Timing of OASIS Measure Data
CMS home health regulations, codified at Sec. 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) \28\ data collected in
accordance with Sec. 484.55(b), (c) and (d) in order to meet the
Medicare CoPs, and as a condition for payment at Sec. 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 (Sec. 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 (SOC) (initial assessment) or Resumption of Care (ROC)
OASIS assessment and a Transfer or Discharge OASIS 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 Sec. 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--
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\28\ For detailed information on OASIS see the official CMS web
resource available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits.
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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 proposed 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 Sec.
484.250(a) and OASIS data described in Sec. 484.55(b), (c) and (d). We
stated in the proposed rule that 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 proposed that the underlying source
[[Page 62314]]
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 proposed to use raw OASIS
assessments to calculate applicable measure scores consistent with how
we developed these measures.
We solicited comment on our proposals. We summarize in this section
of this rule comments received and provide our responses.
Comment: Several commenters were interested in knowing, if the HHA
discharges the patient to either inpatient hospice care, or home
hospice care, will declines in outcomes scored on the Home Health
Discharge OASIS be counted against the HHA or would those declines be
considered an outlier due to the patient transfer or discharge to a
Hospice Provider. Another commenter questioned whether the agency data
proposed to be collected from OASIS for completed episodes of care is
SOC or ROC to discharge. Commenters expressed concern that if a patient
opts for hospice, there is no ability to exclude these patients from
the payment calculation at this point.
Response: For some of the HHVBP OASIS measures, such as the TNC
measures, OASIS items used in calculating the measure are only
collected at discharge \29\ and therefore episodes that end in transfer
are excluded from the measure calculation.\30\
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\29\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/draft-OASIS-D-Guidance-Manual-7-2-2018.pdf.
\30\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-QRP-QM-Users-Manual-V10-August-2019.pdf.
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If the home health episode ends with a transfer to an institutional
provider (M0100 = 06 or 07) or death (08), then the patient would be
excluded from the Dyspnea, Oral Medications, TNC Mobility, and TNC
Self-Care measures because the OASIS items that these measures use are
not collected at the time of transfer for these patients. Patients who
are transferred to an inpatient hospice facility count as a ``transfer
to an inpatient facility'' (07) and are not included in the OASIS-based
measures, while patients discharged to in-home hospice count as regular
discharges (09) and are included in the OASIS-based measures. The two
claims-based measures use the 60 days after the start of home health,
and there are no exclusions for patients who go to a hospice. It is
correct that an OASIS quality episode of care does go from SOC/ROC to
transfer/discharge.
Comment: Commenters discouraged CMS from including future VBP
measures that are not collected in the OASIS data set (or through
HHCAHPS or claims). Commenters stated that this would help prevent
duplicative data collection and reduce administrative burden for
agencies and assist HHAs to achieve better outcomes.
Response: We note that we may, through future rulemaking, add new
measures to the expanded Model where data is not already collected in
order to study them for their appropriateness in the home health
setting. As discussed in the proposed rule, if we consider adding new
measures that require data that is not already collected through
existing quality measure data reporting systems, we would propose that
in future rulemaking being mindful of provider burden. We note that the
proposed measure set for the expanded Model uses data already collected
through OASIS, claims, and HHCAHPS.
Final Decision: After consideration of the comments received, we
are finalizing our proposals on the form, manner and timing of OASIS
measure data as proposed. We reiterate that CY 2022 quality data will
not be used to impact payments to eligible HHAs in CY 2024. CY 2023
will be the first year in which the data collected on the OASIS,
claims, and HHCAHPS measures in the expanded HHVBP Model's set will be
assessed to determine payment adjustments for eligible HHAs in the
expanded HHVBP Model in CY 2025, the first payment year under the
expanded Model.
(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 proposed similar
requirements that align with the HH QRP HHCAHPS survey measure data
reporting requirement at Sec. 484.245(b)(1)(iii). Specifically, under
the expanded Model we proposed 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 [email protected].
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 proposed to codify these proposals at Sec.
484.355(a)(1)(ii).
We requested public comment on these proposals.
Final Decision: We did not receive comments on these proposals and
are finalizing our proposals, including our proposed regulation text at
Sec. 484.355(a)(1)(ii), as proposed.
(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
[[Page 62315]]
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 proposed 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 requested comment on our proposal.
Final Decision: We did not receive comments on this proposal and
are finalizing our proposal as proposed.
(4) Data Reporting for Monitoring and Evaluation of the Expanded HHVBP
Model
Consistent with requirements under the original HHVBP Model at
Sec. 484.315(c), we proposed 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.\31\ We also proposed to codify this at Sec.
484.355(b).
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\31\ See 1115A(b)(4) of the Act (42 U.S.C. 1315a).
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We sought public comment on these proposals.
Comment: A commenter strongly recommended that CMS have a clear,
ongoing plan to monitor beneficiary access in place from the inception
of the expanded model, including distribution of HHAs in historically
underserved areas. The commenter stated that the monitoring plan should
be as close to real-time as is operationally feasible and include steps
for corrective action for those HHAs found to be avoiding complex
patients. The commenter stated that monitoring also should incorporate
beneficiary input, such as surveys and focus groups, as well as
frequent assessments of the numbers and types of beneficiary complaints
and appeals.
Response: We thank the commenter for their recommendations. We will
continue to evaluate and monitor the expanded HHVBP Model and will take
the commenter's recommendations under consideration.
Final Decision: After consideration of comments received, we are
finalizing our proposals as proposed, including our proposed regulation
text at Sec. 484.355(b).
(5) 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
As discussed in section III.A.11. of the proposed rule and this
final rule, we proposed 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 proposed 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 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 proposed 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 multi-stakeholder 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 did not propose to waive step 2 of the 6 steps in
the pre-rulemaking 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 proposed 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. We stated in the proposed rule
that 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 stated that 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. We stated that 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.
We stated in the proposed rule that 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 sought 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.
We summarize in this section of this rule comments received and
provide our responses.
[[Page 62316]]
Comment: A couple of commenters encouraged CMS to maintain current
processes when developing, considering, and implementing new quality
measures in any Medicare quality program, particularly for those
measures that are not NQF endorsed and suggested CMS consider
establishing a streamlined but standardized pathway applicable to the
expanded HHVBP model that would allow for stakeholder input without
unnecessarily delaying adoption of high-value measures.
Response: We agree that stakeholder input is valuable to future
measure set modifications for the HHVBP expanded model. As stated
previously, in section III.A.6.5 of this final rule, we plan to
continue to seek input on the measure set, including from stakeholders
of various fields of expertise and to monitor quality measure
performance to inform potential measure set changes under the expanded
Model.
Final Decision: After consideration of the public comments we
received, we are finalizing our proposal as proposed.
7. Performance Scoring Methodology
a. Considerations for Developing the 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 proposed to apply a similar
methodology for the expanded HHVBP Model. We explain later in this
section how we proposed 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.
We stated in the proposed rule that 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. We stated that by limiting the improvement score to a
scale across 0 to 9, we prioritize achievement relative to improvement.
Fifth, we stated that 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 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. Performance Score Methodology
(1) Overview
We stated in the proposed rule that 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
final 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 final 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 final 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
final 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 final 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 proposed that we would assess each HHA's TPS based upon
all applicable quality measures (defined later in this section) in the
expanded Model measure set in the applicable performance year. Each
competing HHA would receive an interim assessment on
[[Page 62317]]
a quarterly basis, as described in detail in section III.A.9.a. of this
final 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 final
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 final
rule.
As noted, we proposed 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. We stated in the proposed rule that the primary changes
between the original Model and the expanded Model would be that first,
because we were 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
proposed small changes to the achievement and improvement score
formulas to simplify their calculation and interpretation, without
materially changing the output. We also proposed to calculate
benchmarks and achievement thresholds based on national volume-based
cohorts, as opposed to the State-based cohorts under the original
Model, to align with the proposal for volume-based cohorts as described
in section III.A.4. of this final rule. Finally, we proposed 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. We
stated that 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) Calculation of the Benchmark and Achievement Threshold
For scoring HHAs' performance on measures in the claims-based,
OASIS-based, and the HHCAHPS survey-based categories, we proposed
similar elements of the scoring methodology as set forth in the
original Model (as described in Sec. 484.320), including allocating
points based on achievement or improvement and calculating those points
based on benchmarks and thresholds. As finalized in section
III.A.5.b.1. of this final rule, with the exception of new HHAs, the
baseline year would be CY 2019 (January 1, 2019 through December 31,
2019) for the CY 2023 performance year/CY 2025 payment year and
subsequent years. All benchmarks and achievement thresholds would be
set based on HHA performance in the designated baseline year.
We proposed 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 proposed 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 larger- and smaller-
volume cohorts. We proposed 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 larger-
and smaller-volume cohorts. Unlike the original Model, for the expanded
HHVBP Model, we proposed to use a national sample separated into
larger-volume 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 final rule. We also proposed
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 proposed to codify the proposed
definitions of achievement threshold, benchmark, and improvement
threshold at Sec. 484.345. We sought public comment on these
proposals.
Final Decision: We did not receive comments on these proposals and
are finalizing these proposals as proposed, including the proposed
definitions of achievement threshold, benchmark, and improvement
threshold at Sec. 484.345.
(i) 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 proposed 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 proposed 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 final rule. We proposed to calculate the
achievement score using the following formula:
[[Page 62318]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.042
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 proposed
that the maximum achievement points would be capped at 10 achievement
points. As under the original Model, we proposed 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 proposed 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 proposed 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
final rule. We also proposed to codify these proposals at Sec.
484.360. We sought public comment on these proposals.
Final Decision: We did not receive comments on these proposals and
are finalizing our proposals as proposed, including our proposed
regulation text at Sec. 484.360.
(ii) 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 proposed 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. We
stated in the proposed rule that 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 proposed 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
volume-based 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:
[GRAPHIC] [TIFF OMITTED] TR09NO21.043
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 proposed
that the maximum improvement points would be capped at 9 improvement
points. Like the achievement points, we proposed 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 proposed 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 proposed 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 9 possible points, as previously stated.
(We note that the discussion in the proposed rule referred to 10 rather
than 9 possible points in error.) 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
[[Page 62319]]
III.A.7.e.(2).(iii). of this final rule. We also proposed to codify
these proposals at Sec. 484.360. We sought public comment on these
proposals. We summarize in this section of this rule comments received
and provide our responses.
Comment: A commenter requested that we no longer score improvement
in quality measures relative to the baseline and only use the
achievement score for calculating the TPS. The commenter stated that
having one continuous performance scale results in every HHA having an
incentive to improve, leaving no need for an improvement score, in
addition to creating uniform beneficiary expectations.
Response: We thank the commenter for their feedback on the proposed
improvement score. While we agree with the commenter that the
achievement score maintains the incentive to improve in the long-term,
we believe that continuing to include the improvement score methodology
is important in the initial years of the expanded model. This will
allow HHAs with lower measure performance historically to be rewarded
for improving upon those scores, even if the improvement does not move
them into the highest performing tier of HHAs. By setting the highest
possible improvement score out of 9 points, compared to the achievement
score out of 10 points, we place a stronger emphasis on achievement
relative to improvement. Furthermore, we note that this would be
consistent with existing value-based purchasing programs.
Comment: Several commenters expressed concern with using the
improvement score methodology to assess HHAs on each of the quality
measures, asserting that it may lead HHAs to exclude beneficiaries who
are unlikely to improve.
Response: We believe that these comments may be in reference to
certain quality measures, rather than the improvement score
methodology, and refer readers to our earlier responses regarding why
we do not believe the measure set would disincentivize HHAs from
serving beneficiaries who are less likely to improve. The improvement
score methodology assesses improvement of HHAs across each of the
applicable measures and does not measure improvement of beneficiaries
over time.
Final Decision: After consideration of the public comments we
received, we are finalizing our proposals as proposed, including our
proposed regulation text at Sec. 484.360.
(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, OASIS-based, and the HHCAHPS survey-
based categories. As previously discussed, we are finalizing CY 2023 as
the first performance year and have updated the following examples from
the proposed rule to reflect CY 2023 as the performance year. Other
than the updating the hypothetical performance year from CY 2022 to CY
2023, all other detail in the following examples from the proposed rule
remain the same. These HHA examples are based on illustrative data from
CY 2019 (for the baseline year) and hypothetical data for CY 2023 (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
2023 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 2023 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.\32\ Calculating HHA B's improvement score yields the following
result: Based on HHA B's period-to-period improvement, from 52.168 in
the baseline year to 76.765 in the performance year, HHA B would earn
4.864 improvement points, calculated as follows: 9 * (76.765 - 52.168)/
(97.676 - 52.168) = 4.864.\33\ Because the higher of the achievement
and improvement scores is used, HHA B would receive 4.864 improvement
points for this measure.
---------------------------------------------------------------------------
\32\ The finalized formula for calculating achievement points is
10 * (HHA Performance Year Score - Achievement Threshold)/(Benchmark
- Achievement Threshold).
\33\ The finalized formula for calculating improvement points is
9 * (HHA Performance Year Score - HHA Improvement Threshold)/(HHA
Benchmark - HHA Improvement Threshold).
---------------------------------------------------------------------------
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.
[[Page 62320]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.044
[[Page 62321]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.045
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 proposed to apply the same policies
around minimum case counts for each measure as implemented under the
original Model, as described in proposed Sec. 484.345. We proposed to
continue to award an HHA the higher-of achievement or improvement
points, as discussed previously, for ``applicable measures'' only.
Under this proposal, for the measures included in the claims-based 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
proposed this minimum to align with the original HHVBP Model and the
measure specifications used for the Patient Quality of Care Star
Ratings.\34\ For the individual components that compose the HHCAHPS
survey measure, we proposed that an ``applicable measure'' means a
component for which a competing HHA has submitted a minimum of 40
completed HHCAHPS surveys. We stated that 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.\35\
---------------------------------------------------------------------------
\34\ Centers 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-methodologyapril-2020.pdf.
\35\ Centers 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.
---------------------------------------------------------------------------
We also proposed to codify this proposed definition of an
``applicable measure'' at Sec. 484.345. We solicited public comment on
these proposals.
Final Decision: We did not receive comments on these proposals and
are finalizing our proposals as proposed, including the proposed
definition of an ``applicable measure'' at Sec. 484.345.
d. Minimum Number of Applicable Measures for an HHA To Receive a Total
Performance Score
For the expanded Model, we proposed to apply the same policies
around the minimum number of applicable measures to receive a TPS, as
implemented under the original Model. We proposed that, beginning with
the CY 2022 performance year, which we are delaying until CY 2023 as
the first performance year as described in section III.A.3 of this
final rule, 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 claims-based 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 stated that we believe
that a minimum of five applicable measures allows for a
[[Page 62322]]
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 proposed
that other applicable policies under the expanded HHVBP Model would
still apply. We proposed that these HHAs 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 at the time of the
development of the proposed rule, 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 proposed to codify this proposal at Sec. 484.360(c). We
sought public comment on this proposal.
Final Decision: We did not receive comments on this proposal and
are finalizing our proposal as proposed, including our proposed
regulation text at Sec. 484.360(c). As previously discussed, we are
finalizing CY 2023 as the first performance year and CY 2025 as the
first payment year under the expanded Model. We reiterate that HHAs
will not be assessed on their performance on the quality measures
during the CY 2022 pre-implementation year. As noted later in this
rule, we will continue to collect and evaluate data under the expanded
HHVBP Model during CY 2022 and anticipate providing sample reports to
HHAs, where administratively feasible and based on available data, for
learning purposes only. The sample report would include the same
information as an Interim Performance Report (IPR), and would be based
on the same scoring methodologies and other policies as finalized in
this rule for a performance year. We also anticipate providing learning
support to all HHAs during CY 2022 including, for example, scenario-
based performance reports and related learning events on the content of
the reports and how they can be used to supplement an HHA's quality
improvement efforts.
e. Weights for the Claims-Based, OASIS-Based, and HHCAHPS Survey
Measures
Except for removing the New Measures category, for the expanded
HHVBP Model, we generally proposed 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) Weighting and Re-Distribution of Weights Between the Measure
Categories
In the proposed rule, we proposed to group the expanded Model
proposed measures into measure categories based on their data source as
indicated in Table 27: Claims-based, OASIS-based, and the HHCAHPS
survey-based. We proposed that claims-based, OASIS-based, 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 proposed 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 re-distributing 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 claims-based 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.36 37 Finally, we proposed that if
two measure categories are missing, the remaining category would be
weighted 100 percent. We refer readers to Table 28 for the distribution
of measure category weights under various scenarios.
---------------------------------------------------------------------------
\36\ OASIS-based measures reweighting = 35% original OASIS
weight/(35% original OASIS weight + 30% original HHCAHPS weight) =
53.85% revised OASIS weight.
\37\ HHCAHPS reweighting = 30% original HHCAHPS weight/(35%
original OASIS weight + 30% original HHCAHPS weight) = 46.15%
revised HHCAHPS weight.
---------------------------------------------------------------------------
(2) Quality Measure Weights Within Measure Categories
Within the measure categories, we proposed 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 proposed that all 5
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 proposed 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 proposed 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, re-distributing 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 proposed 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 proposed to weight them slightly more than the
[[Page 62323]]
other 3 measures, which are not composite measures, as under the
original Model. Under this proposal, should any measures in the
category be missing, we proposed 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.38 39 40
---------------------------------------------------------------------------
\38\ TNC 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.
\39\ 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.
\40\ Oral 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.
---------------------------------------------------------------------------
See Table 27 for a comprehensive list of the proposed within-
category measure weights.
[GRAPHIC] [TIFF OMITTED] TR09NO21.046
Table 28 presents the proposed weights for the proposed measures
and measure categories under various reporting scenarios.
[[Page 62324]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.047
We also proposed to codify these proposals at Sec. 484.360. We
solicited public comment on these proposals.
Final Decision: We did not receive comments on these proposals and
are finalizing our proposals as proposed, including our proposed
regulation text at Sec. 484.360.
f. Examples of the Total Performance Score Calculation
The following are two examples of the finalized 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 measures. Under the finalized
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 29 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.
[[Page 62325]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.048
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 percent 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.
[[Page 62326]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.049
8. 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 stated in the proposed rule that 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 proposed to codify at Sec.
484.370 a methodology for applying value-based payment adjustments to
home health services. We proposed that payment adjustments would be
made to the HH PPS final claim payment amount as calculated in
accordance with HH PPS regulations at Sec. 484.205 using a LEF,
similar to the methodology utilized by the HVBP Program (76 FR 26533).
We proposed 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 proposed 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 percent (the proposed maximum payment
adjustment for CY 2024; as previously discussed, we are finalizing CY
2025 as the first payment year of the expanded Model) 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 proposed 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'
`X-percent 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 31 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
proposed CY 2024 payment year.
[[Page 62327]]
Step #1 involves the calculation of the `Prior Year Aggregate HHA
Payment Amount' (C2 in Table 31) that each HHA was paid from claims
data under the HH PPS in the year prior to the performance year. For
the proposed CY 2024 payment year, from claims data, all payments are
summed together for each HHA for CY 2021, the year prior to the
proposed performance year.
Step #2 involves the calculation of the `5-percent Payment
Reduction Amount' (C3 of Table 31 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 31 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 31) 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 31) 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 31) 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 31) 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
proposed 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 proposed to codify this payment methodology policy at Sec.
484.370. We invited comments on this proposal. We summarize in this
section of this rule comments received and provide our responses.
[GRAPHIC] [TIFF OMITTED] TR09NO21.050
Comment: A commenter asked about the ``X-percent Adjustment
Percentage'' and how would an HHA know this value.
Response: We believe the commenter is inquiring about the ``X-
percent Payment Reduction Amount.'' The ``X-percent Payment Reduction
Amount'' is the maximum payment adjustment possible for an HHA under
the HHVBP expanded model for the payment year. As discussed in section
III.A.5.a of this final rule, we are finalizing that the maximum
payment adjustment under the expanded Model would be 5 percent for CY
2025, the first payment year under the expanded Model, and subsequent
years.
Comment: A few commenters stated that there is likely no
significant difference between an HHA in 45th percentile and 55th
percentile, but the HHA in the 45th percentile will receive a payment
reduction and the HHA in the 55th percentile will receive a payment
increase. A commenter asked CMS to make it more realistic to achieve
the maximum bonus or penalty. Another commenter asked CMS to re-
evaluate the current payment adjustment structure because it is
difficult to score within the top or bottom decile. The commenter
stated that most HHAs fall in the middle of the curve and relatively
neutral payment impact does not incentivize them to make significant
changes. Conversely, a commenter recommended that we reward positive
performance and not apply a negative adjustment to low performing HHAs.
[[Page 62328]]
Response: Under the original HHVBP Model, we used the LEF to
translate an HHA's TPS into a percentage of the value-based payment
adjustment earned by each HHA. The LEF is similar to the methodology
utilized by the HVBP program. The LEF was identified by the HVBP
Program as the simplest and most straightforward option to provide the
same marginal incentives to all hospitals, and we found the same to be
true for HHAs under the original HHVBP Model. It is true that an HHA in
the 45th percentile and an HHA in the 55th percentile could have a
similar TPS and one could have a small positive payment adjustment and
one could have a small negative payment adjustment. The possibility of
either a negative or a positive payment adjustment incentivizes HHAs to
improve quality. While we agree that a majority of the HHAs fall into
the middle of the pack and most do not receive the maximum positive or
negative payment adjustment, we disagree that HHAs are not incentivized
to make significant changes unless it is easier to receive the maximum
positive or negative payment adjustment. During the original HHVBP
Model, we noted improvements in quality, as noted by a decrease in
unplanned hospitalizations, emergency department visits leading to
inpatient admission and skilled nursing facility use, and a $604.8
million (1.3 percent) reduction of Medicare spending as noted in the
HHVBP Fourth Annual Evaluation Report.\41\
---------------------------------------------------------------------------
\41\ https://innovation.cms.gov/data-and-reports/2021/hhvbp-fourthann-rpt.
---------------------------------------------------------------------------
Comment: A commenter expressed concern about an endless loop of
rewarding the top half of HHAs and penalizing the lower half of HHAs.
Response: We appreciate the concern of the commenter, but based on
our examination of the data from the original HHVBP Model, we found
that many HHAs moved between negative and positive payment adjustments.
Of the HHAs that received a payment adjustment under the original Model
in both CY 2019 and CY 2020, 15.4 percent moved from a negative
adjustment to a positive adjustment, 15.5 percent moved from a positive
adjustment to a negative adjustment, 33.6 percent had a negative
adjustment in both years, and 35.5 percent had a positive adjustment in
both years. Accordingly, because many HHAs moved from negative
adjustments to positive adjustments and vice versa under the original
Model, we disagree that there would be an endless loop of rewarding the
top half and penalizing the lower half of HHAs.
Final Decision: After consideration of the public comments we
received, we are finalizing the payment adjustment methodology as
proposed, including our proposed regulation text at Sec. 484.370.
9. Performance Feedback Reports
We proposed 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. 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. We proposed that
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
discussed in section III.A.10. of this final rule (Appeal Processes).
In the proposed rule, 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 proposed to provide each HHA with an IPR that contains
information on its performance during the 12 most recent months of data
available. We proposed to provide the 12 most recent months of data
because the 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 real-time performance information
as possible. We stated in the proposed rule that we expect to make the
first IPR available in July 2022 and make IPRs for subsequent quarters
available in October, January, and April. We stated that 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 proposed that the IPRs would
include a competing HHA's expanded HHVBP Model-specific performance
results with a comparison to other competing HHAs within its applicable
nationwide cohort (larger- or smaller-volume). We proposed 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 noted 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, as
proposed, 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 iQIES-generated reports are not limited by a quarterly run-out
of data and a calculation of competing peer-rankings. The primary
difference between iQIES-generated reports and expanded HHVBP Model-
specific performance reports is that the Model-specific performance
report we proposed 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
[[Page 62329]]
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.\42\ We noted 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 proposed 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.
---------------------------------------------------------------------------
\42\ iQIES manuals are available at https://qtso.cms.gov/software/iqies/reference-manuals.
---------------------------------------------------------------------------
We invited public comment on our proposals. We summarize and
respond to comments on both the proposed IPRs and the proposed Annual
Reports and present our final policies in the next section.
b. Annual TPS and Payment Adjustment Report
We proposed 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
proposed payment adjustment year, expected beginning in August 2023. We
proposed 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 proposed 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 proposed 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 final 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 proposed 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 final rule (Appeal Processes). As under the original
Model, we proposed 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.
We stated that 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. We proposed that 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
Sec. 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. We stated that 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. We stated that 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.
We stated that data related to performance on quality measures
would continue to be provided for the baseline year and all performance
years of the expanded Model via a CMS data platform, such as the iQIES
(this platform would present and might archive the previously described
IPR and Annual Reports). We presented a sample timeline in Table 33 of
the proposed rule showing the availability of each expanded HHVBP
Model-specific performance report and the data included for the
proposed CY 2022 performance year and CY 2024 payment year.
We sought public comment on our proposals related to the Interim
Performance and Annual Reports. We summarize in this section of this
rule comments received and provide our responses.
Comment: A commenter requested that CMS continue to provide
quarterly reports to HHAs.
Response: We are committed to providing the quarterly IPRs to HHAs
in the expanded HHVBP Model, just as we did in the original HHVBP
Model.
Comment: A few commenters requested that performance feedback
reports be completed in a timely manner. Another commenter requested
that performance feedback reports be provided earlier so HHAs have the
opportunity to adjust operations as early as possible. Another
commenter requested that performance feedback reports be provided no
later than January 2022.
Response: We are committed to providing performance feedback
reports, both the quarterly IPRs and Annual Reports, as soon as
administratively feasible. We understands that both the IPRs and Annual
reports are important tools that HHAs use to help adjust operations to
improve quality. Due to the lag time between data submission and data
processing of claims, HHCAHPS, and OASIS data, CMS is unable to provide
the first IPR that includes CY 2023 performance year data for the first
quarter quality measure performance scores any earlier than July 2023,
as detailed in Table 32. As described in section III.A.3 of this rule,
We have finalized the payment adjustments for the expanded HHVBP model
to start in CY 2025 instead of CY 2024. We will provide sample reports
as soon as administratively feasible and learning support during CY
2022 on the content of the IPRs and Annual Reports to allow HHAs to
learn how the HHVBP quarterly reports can support their quality
improvement efforts and potentially make adjustments to their
operations as they see fit.
Comment: A commenter requested that CMS provide the baseline report
as soon as possible, another commenter suggested CMS provide the
baseline report before the performance year starts and another
commenter suggested publishing the baseline report with this final
rule.
Response: We understand that HHAs want to have time to examine
their baseline data as soon as possible and anticipate making available
baseline reports using the CY 2019 baseline year data in advance of the
first performance
[[Page 62330]]
year under the expanded Model (CY 2023). As noted, we will also make
available during the CY 2022 pre-implementation year sample reports to
individual HHAs via iQIES as soon as administratively feasible. The
sample reports will provide, based on the data available, achievement
threshold, benchmark, improvement threshold, and quality performance
data.
Comment: A commenter requested that CMS thoroughly test the iQIES
system to ensure that it is capable and prepared to provide the IPRs
and Annual Reports to HHAs.
Response: We note that the iQIES already provides similar
functionality in providing reports to HHAs for other purposes, and we
have tested iQIES for acceptance of the file format to be used for the
HHVBP model-reports and the test was successful.
Final Decision: After consideration of the public comments we
received, we are finalizing our proposals for the proposed IPRs and
Annual TPS and Payment Adjustment Reports, with modification, to
reflect that CY 2023 will be the first performance year and CY 2025 the
first payment year under the expanded Model, with CY 2022 as a pre-
implementation year. We will continue to collect and evaluate data
under the expanded HHVBP Model during CY 2022 and anticipate providing
sample reports to HHAs, where administratively feasible and based on
available data, for learning purposes only. The sample report would
include the same information as an IPR, and would be based on the same
scoring methodologies and other policies as finalized in this rule for
a performance year. We also anticipate providing learning support to
all HHAs during CY 2022 including, for example, scenario-based
performance reports and related learning events on the content of the
reports and how they can be used to supplement an HHA's quality
improvement efforts.
As noted, CY 2023 will be the first performance year and CY 2025
will be the first payment year under the expanded Model. We expect to
make the first IPR available in July 2023 and make IPRs for subsequent
quarters available in October, January, and April. The July 2023 IPR
would be the first IPR issued that includes CY 2023 performance year
data for the first quarter quality measure performance scores on the
OASIS-based measures and baseline data for the HHCAHPS survey and
claims-based measures. HHAs will be notified in advance of the first
annual total performance score and payment adjustment being finalized
for CY 2025. The total performance score and payment adjustment will be
based on the CY 2023 performance year (January 1, 2023 to December 31,
2023), 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 Sec. 484.205 for HHA services furnished
January 1, 2025 through December 31, 2025.
Subsequent payment adjustments will 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, 2026 through December 31,
2026, based on a full 12 months of the CY 2024 performance year.
Notification of the second pending payment adjustment would occur in
approximately August 2025 when the Preview Annual Report is issued,
followed by the Preliminary (if applicable) and Final Annual Reports,
as described previously.
We present in Table 32 a sample timeline showing the availability
of each expanded HHVBP Model-specific performance report and the data
included for the CY 2023 performance year and CY 2025 payment year.
[GRAPHIC] [TIFF OMITTED] TR09NO21.051
10. Appeals Processes
As codified at Sec. 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
[[Page 62331]]
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 proposed to use the same appeals
process as the original Model. We proposed 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. Recalculation Request Process
Under the expanded HHVBP Model, we proposed 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 proposed 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 proposed 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 proposed 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
webpage. We proposed 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 proposed that recalculation requests (quarterly Preliminary IPR
or Preview Annual Report recalculations) 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 Model-specific webpage.
Following receipt of a recalculation request, we proposed 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 stated that
we anticipate providing this response as soon as administratively
feasible following the submission of the request.
We also proposed to codify the recalculation process at Sec.
484.375(a). We invited comment on our proposals.
Comment: A commenter requested that CMS consider 30 calendar days
for HHAs to review and request recalculations.
Response: While we appreciate that HHAs may want additional time to
review the IPRs and Annual Reports, we believe that this proposed
timeframe for submission of reconsideration requests is needed to allow
for two levels of appeal prior to the payment adjustments being
applied. The original HHVBP model used the same appeal process,
including the 15 calendar day period for HHAs to submit recalculation
requests, to allow for recalculations of the IPRs to be completed prior
to the posting of the Annual Report in August and to allow both levels
of appeals to be completed prior to the generation and submission of
the final data files in advance of the applicable payment year. We
proposed this same timeframe for submission of recalculation requests
under the expanded Model in order to complete the entire appeals
process for all HHAs timely, both the recalculations and
reconsideration requests, and allow the Medicare Administrative
Contractors (MACs) time to update each HHA's payment adjustment before
the payment adjustment year. As discussed in the proposed rule, the
recalculation process allows HHAs to request scoring recalculations or
address discrepancies in the payment adjustment calculation, but
changes cannot be made to the underlying data. We therefore believe
that 15 calendar days is a sufficient amount of time to determine
whether a recalculation is needed, collect supporting data, and submit
a recalculation request following the posting of the Preliminary IPRs
and Preview Annual Reports.
Final Decision: After consideration of the public comments we
received, we are finalizing the proposed reconsideration process. We
are also finalizing our proposed regulation text at Sec. 484.375(a).
b. Reconsideration Process
Under the expanded Model, we proposed 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 proposed
that an HHA may request reconsideration of the outcome of a
recalculation request for its Preliminary Annual Report only. We stated
that 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 stated that 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
[[Page 62332]]
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 webpage 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 stated that 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 proposed 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 proposed to codify the reconsideration process at Sec.
484.375(b).
We solicited comments on these proposals. We did not receive any
comments on the proposed reconsideration process.
Final Decision: We are finalizing the reconsideration process as
proposed. We are also finalizing our proposed regulation text at Sec.
484.375(b).
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 final rule, where we discuss our proposal to modify
our public reporting policy for the original Model, given our proposal
as discussed in section III.B.2. of this final 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.
b. Public Reporting for the Expanded Model
We stated in the proposed rule that 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 proposed to publicly report performance
data for the expanded HHVBP Model beginning with the proposed CY 2022
performance year/CY 2024 payment adjustment and for subsequent years.
For all years of the expanded HHVBP Model, we proposed 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 proposed to report these data by State, CCN, and agency name
through a CMS website. We noted 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 proposed 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 stated that 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 proposed to
publicly report those measure results as well.
We stated that 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 proposed 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 stated
[[Page 62333]]
that 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 aligned), 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 stated in the proposed rule that 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 stated we would intend to
complete the proposed CY 2022 Annual Report appeals process and
issuance of the Final Annual Report to each competing HHA. For each
year thereafter, we stated that 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 proposed to codify these proposals at Sec. 484.355(c).
We sought public comment on these proposals.
Comment: A commenter expressed concern that publicly reported
measure scores may be misinterpreted since non-identical results could
be generated between the HHVBP and HH QRP measure sets on Care Compare
due to different baseline periods and scoring methodologies. Another
commenter had a similar concern related to inconsistencies between the
TPS and the star rating system. Both commenters recommended CMS take
extra effort in the presentation of the results in order to assist
beneficiaries in understanding why the results may not be identical.
Response: As noted in the proposed rule, we will provide
definitions for the TPS and the TPS Percentile Ranking methodology on
the CMS website to assist in interpretation of these results. As the
commenter notes, the TPS and the star rating system may have non-
identical results; however, we believe this increases the information
available to the beneficiary and their family, and allows for greater
transparency. In consideration of the public comments we received, we
are considering additional methods to clarify this publicly reported
data to assist in accurate public interpretation and understanding of
the data results.
Final Decision: After consideration of comments received, we are
finalizing our proposal with modification. As previously described in
this final rule, payment adjustments under the expanded HHVBP model
will start in calendar year 2025 instead of calendar year 2024. As
such, public reporting of performance data for the expanded HHVBP Model
will begin with the CY 2023 performance year/CY 2025 payment adjustment
and for subsequent years. We anticipate this information would be made
available to the public on a CMS website on or after December 1, 2024,
the date by which we would intend to complete the CY 2023 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.
We are finalizing codification of this proposal at Sec.
484.355(c).
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 short-term, 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 proposed 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
reporting requirements in the event of extraordinary circumstances
beyond HHAs' control.
Specifically, we proposed 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 proposed 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 stated that 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
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 proposed to codify our ECE policy at Sec. 484.355(d).
We solicited public comment on our proposals.
Final Decision: We did not receive comments on this proposal and
are finalizing our proposals as proposed, including our proposed
regulation text at Sec. 484.355(d).
[[Page 62334]]
B. Provisions Under the Home Health Value-Based Purchasing (HHVBP)
Original Model
1. Background
We stated in the proposed rule that 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),\43\ 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. We stated that
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.
---------------------------------------------------------------------------
\43\ OASIS is the instrument/data collection tool used to
collect and report performance data by HHAs.
---------------------------------------------------------------------------
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 Sec.
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-exceptions-and-extensions-quality-reporting-and-value-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. CY 2022 Payment Adjustments
For the reasons discussed in this section, we proposed 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 proposed 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 stated in the proposed rule
that 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 stated in the proposed rule that we do not believe it would be
appropriate to utilize data from that time period to calculate a TPS
for CY 2020 that would 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 stated that we are concerned that because the COVID-19
PHE has not impacted all HHAs equally,
[[Page 62335]]
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 stated that 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 stated that 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. We stated that 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 noted 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).
Based on data available for this final rule, we note that, as found
in Q1 and Q2 2020, OASIS assessments and claims-based home health stays
decreased in Q3 and Q4 2020 as compared to Q3 and Q4 2019. We observed
a 1.3 percent decrease in OASIS assessments and a 10.2 percent decrease
in claims-based home health stays when comparing Q3 and Q4 2020 to Q3
and Q4 2019.
As stated in the proposed rule, after consideration of these
issues, we proposed 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. We stated that 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. Based on data available for
this final rule, we observed that using two quarters of 2020 data (Q3
and Q4 2020) as compared to using four quarters of 2020 data (Q1
through Q4 2020), would result in two-thirds of episodes of care being
eliminated. As previously noted, data submissions in Q3 and Q4 2020
also remained lower than Q3 and Q4 2019 submissions. We stated in the
proposed rule that 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. We stated that 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 noted 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). We stated that as we
proposed to not use CY 2020 (performance year 5) data to calculate CY
2022 (payment year 5) payment adjustments, these years would not be
evaluated. As we clarify in response to comments in this section, CMS
does intend to include CY 2020 in its evaluation, during which the 6
percent payment adjustment is applied.
We stated that 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 proposed 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 noted 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 proposed to amend at Sec. 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 invited public comment on our proposal. We summarize in this
section of this rule comments received and provide our responses.
Comment: Several commenters opposed ending the model early and
stated CMS should provide the 2022 incentive payments that would
otherwise be made to HHAs in the nine states. Commenters opposed ending
the model early stating that the final year should be evaluated. A
commenter did not support ending the original model early, stating that
if there is concern with impacts to the data due to the PHE, CMS should
apply a risk adjuster to account for it.
Response: As previously described, based on our analyses of the CY
2020 data for this final rule, the volume and utilization patterns we
observed in the Q1 and Q2 2020 data were also observed in the data for
Q3 and Q4 2020, when compared to the same time period in CY 2019.
Because the COVID-19 PHE did not impact all HHAs equally, we continue
to believe that implementing payment adjustments based on the impacted
data could unfairly penalize certain HHAs. While we also considered
using only Q3 and Q4 CY 2020 quality measure data to calculate CY 2020
annual total performance scores for CY 2022 payment adjustments, we
found that, when compared to using four quarters of CY 2020 data, 13
percent of HHAs would no longer have enough data at all to receive a
TPS; only one state would have enough HHAs for a small cohort (compared
to four states with full year data); 15 percent of HHAs would no longer
have enough claims data to contribute to their TPS; and, 22 percent of
HHAs would no longer have enough HHCAHPS data to contribute to their
TPS. Based on our analyses, we continue to believe that using only two
quarters of data is not sufficient
[[Page 62336]]
representation of the care provided by the HHA in CY 2020 for purposes
of calculating quality measure scores and determining payment
adjustments under the Model, and would disadvantage HHAs in an area of
a State more heavily affected by the pandemic in Q3 and Q4 of 2020. We
also continue to believe that the changes in volume and utilization for
CY 2020, which, as noted, were also observed in the Q3 and Q4 2020
data, could skew performance assessments on quality measures for HHAs
such that the calculated TPSs may not accurately reflect the quality of
care provided by HHAs.
In addition, not using the CY 2020 performance year data to
determine payment adjustments under the HHVBP Model would be part of a
larger set of policies we have adopted to deal with quality data we
believe have been significantly affected by circumstances caused by the
COVID-19 PHE. For example, in the FY 2022 Hospice final rule (86 FR
42590-42598), we addressed how HH QRP data affected by the PHE would be
publicly displayed. We finalized a policy that will use three quarters
rather than four quarters of data for the January 2022 refresh
affecting OASIS-based measures. For certain claims-based measures, we
will use three quarters rather than four quarters of data for refreshes
between January 2022 and July 2024. Public reporting with refreshed
data will begin in January 2022. For HHCAHPS, we finalized that 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.
CMS finalized in the FY 2022 SNF PPS final rule (86 FR 19954) to
suppress the Skilled Nursing Facility 30-Day All-Cause Readmission
Measure (SNFRM) for the FY 2022 SNF VBP Program Year because
circumstances caused by the PHE for COVID-19 have significantly
affected the measure and the ability to make fair, national comparisons
of SNFs' performance scores. Under the special scoring policy CMS
finalized for FY 2022, CMS will assign a performance score of zero to
all participating SNFs, to mitigate the effect that PHE-impacted
measure results would otherwise have on SNF performance scores and
incentive payment multipliers. CMS also finalized that it would assign
an identical incentive payment multiplier, resulting in no payment
adjustments for SNFs in FY 2022. We would then apply the Low-Volume
Adjustment policy as previously finalized in the FY 2019 SNF PPS final
rule (83 FR 39278 through 39280). That is, if a SNF has fewer than 25
eligible stays during the performance period for a program year we
would assign that SNF a performance score resulting in a net neutral
payment incentive multiplier. SNFs will not be ranked for the FY 2022
SNF VBP Program.
CMS finalized in the FY 2022 IPPS/LTCH PPS final rule (86 FR 45266
through 45277) that for FY 2022, it would suppress the use of measure
data for a number of measures because circumstances caused by the
COVID-19 PHE have affected those measures and the resulting quality
scores significantly. Because calculating Total Performance Scores
(TPSs) for hospitals based on the remaining measures would not result
in a fair national comparison, CMS also finalized that it would not
calculate a TPS for any hospital and would instead award each hospital
a payment incentive multiplier that results in a value-based incentive
payment that is equal to the amount withheld for the fiscal year (2
percent).
With regard to the comment that CMS should apply a risk adjustor to
account for the PHE, we note that we did not propose to modify the risk
adjustment methodology for the quality measures in the original Model's
measure set. Regarding the comment that the final year of the Model
should be evaluated, we clarify that the Model will be evaluated
through the full period of performance. CY 2020 will be evaluated as
this year reflects the 6 percent payment adjustment applied, based on
CY 2018 performance.
Final Decision: After consideration of public comments, we are
finalizing our proposal not to apply any payment adjustments for CY
2022 and to end the original Model early as proposed. We are also
finalizing to amend at Sec. 484.305 the definition of ``applicable
percent'' by removing paragraph (5) of the definition ((5) For CY 2022,
8 percent) to reflect this final policy.
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 final rule,
we proposed to not use CY 2020 data for CY 2022 payment adjustments
under the HHVBP Model. Consistent with this proposal, we also proposed
to modify our existing policy and not publicly report performance data
for the HHAs included in the original Model. We stated that 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 final rule, we proposed to begin
public reporting for the expanded HHVBP Model with the proposed CY 2022
performance year data, continuing for all performance years thereafter,
and are finalizing to publicly report performance data under the
expanded Model beginning with the CY 2023 performance year data,
continuing for all performance years thereafter.
We proposed to amend Sec. 484.315 to reflect our proposal not to
publicly report performance data from the CY 2020 performance year by
removing paragraph (d). We solicited comments on this proposal.
Final Decision: We received no comments on this proposal and are
finalizing as proposed, including our proposed amendment to Sec.
484.315.
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
[[Page 62337]]
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 decision-making. 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 \44\ 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-and-common-agreement and
https://rce.sequoiaproject.org/.
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\44\ ONC, Draft 2 Trusted Exchange Framework and Common
Agreement, https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf.
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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.\45\ For a healthcare
provider (as defined in 45 CFR 171.102), the law 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).
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\45\ For 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.''
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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 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)
[[Page 62338]]
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
period (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).46 47
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\46\ The HHCAHPS has five component questions that together are
used to represent one NQF-endorsed measure.
\47\ Data collection delayed due to the COVID-19 public health
emergency for the TOH-Patient and TOH-Provider.
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BILLING CODE P
[GRAPHIC] [TIFF OMITTED] TR09NO21.052
BILLING CODE C
[[Page 62339]]
4. Changes for the HH QRP
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\48\ Data collection delayed due to the COVID-19 public health
emergency for the TOH-Patient and TOH-Provider.
\49\ Ibid.
\50\ The HHCAHPS has five component questions that together are
used to represent one NQF-endorsed measure.
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a. Removal of 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.\51\ In line with our
meaningful measures initiative, we proposed 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.
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\51\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.
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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
OASIS-based 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.\52\
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\52\ Home Health Quality Reporting Program Measure Calculations
and Reporting User's Manual https://www.cms.gov/files/document/hh-qrp-qm-users-manual-v1-addendum.pdf.
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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.\53\
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.\54\
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\53\ Analysis of Home Health OASIS episodes from 2010 to 2019.
\54\ The truncated coefficient of variation (TCV) is the ratio
of the standard deviation to the mean of the distribution of all
scores, excluding the 5 percent most extreme scores. A small TCV
(<=0.1) indicates that the distribution of individual scores is
clustered tightly around the mean value, suggesting that it is not
useful to draw distinctions between individual performance scores.
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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 proposed 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.\55\ 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.
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\55\ The 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.
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We invited public comments on these proposals.
Comment: Most commenters supported the removal of the Drug
Education on all Medications Provided to Patient/Caregiver measure.
They supported the rationale supporting our proposal that showed the
measure was less useful to the broader public as a measure with limited
variation in scores across providers.
Response: We thank commenters for their support of the proposal to
remove the Drug Education on all Medications Provided to Patient/
Caregiver measure from the HH QRP. We will continue assess the value of
each measure in the HH QRP to ensure it provides value to patients,
providers and other stakeholders.
Comment: Some commenters supported the measure removal yet
expressed concerns that removal of this
[[Page 62340]]
measure would result in a significant impact on the drug education that
HHAs have provided and requested that CMS continue to monitor drug
education. A few commenters did not support the removal of the drug
education measure out of concern that its removal as one of the patient
safety measures would adversely affect patients.
Response: We appreciate commenters raising the issue of patient
safety. We continue to prioritize patient safety regarding patient
medications. We believe other measures in the HH QRP, specifically the
Improvement in Management of Oral Medications measure, adequately
addresses this domain of patient safety with respect to medications
along with other measures such as the Drug Regimen Review measure.
Final Decision: After careful consideration of the public comments
we received, we are finalizing our proposal to remove of 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 beginning January 1, 2023. HHAs will no longer be required to
submit OASIS Item M2016, Patient/Caregiver Drug Education Intervention
beginning January 1, 2023.\56\ We are finalizing that data for this
measure will be publicly reported on Care Compare through October 1,
2023, after which it would be removed from the site.
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\56\ The 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.
---------------------------------------------------------------------------
b. Replacement of 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 proposed
to replace the Acute Care Hospital 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 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/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Home-Health-Quality-Measures.
(1) Background
Hospitalizations among the Medicare population are common, costly,
and often preventable.57 58 59 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.60 61
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.\62\ 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).\63\ 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.\64\
---------------------------------------------------------------------------
\57\ Friedman, B. and J. Basu, The rate and cost of hospital
readmissions for preventable conditions. Med Care Res Rev, 2004.
61(2): p. 225-40.
\58\ Moy, E., Chang, E., and Barret, M. Potentially Preventable
Hospitalizations--United States, 2001-2009. MMWR, 2013, 62(03);139-
143.
\59\ 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.
\60\ Ibid.
\61\ MedPAC, Payment policy for inpatient readmissions, in
Report to the Congress: Promoting Greater Efficiency in Medicare.
2007: Washington D.C. p. 103-120.
\62\ Wolff, 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.
\63\ Madigan, 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.
\64\ Walsh, 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.
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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.\65\ An additional beneficiary characteristic
that is associated with a potential for hospitalization is the time
since a beneficiary's most recent hospitalization \66\ and chronic
conditions such as chronic obstructive pulmonary disease and congestive
heart failure.\67\ How HHAs address these factors, including how HHAs
address chronic conditions present before the HH stay, can determine
whether beneficiaries can successfully avoid
[[Page 62341]]
hospitalizations.\68\ Understanding these factors can help HHAs design
strategies to address avoidable hospitalizations.
---------------------------------------------------------------------------
\65\ Lohman MC, Cotton, BP, Zagaria, AB, Bao, Y, Greenberg, RL,
Fortuna, KL, Bruce, ML Hospitalization Risk and Potentially
Inappropriate Medications among Medicare Home Health Nursing
Patients, (2017) J Gen Intern Med. 32(12):1301-1308.
\66\ Hua M, Gong, MN, Brady J, Wunsch, H, Early and late
unplanned rehospitalizations for survivors of critical illness
(2015) Critical Care Medicine;43(2):430-438.
\67\ 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.
\68\ Lohman MC, Cotton, BP, Zagaria, AB, Bao, Y, Greenberg, RL,
Fortuna, KL, Bruce, ML Hospitalization Risk and Potentially
Inappropriate Medications among Medicare Home Health Nursing
Patients, (2017) J Gen Intern Med. 32(12):1301-1308.
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Observation stays are also increasing nationally and can have
costly financial impacts, especially for patients.69 70
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.\71\ Limitation of observation stays should be a goal of
HHAs along with efforts to limit inpatient hospitalizations.
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\69\ Lind KD, Noel-Miller CM, Sangaralingham LR, Shah ND, Hess
EP, 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.
\70\ Feng 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.
\71\ Sabbatini AK, Wright B. Excluding Observation Stays from
Readmission Rates--What Quality Measures Are Missing, New England
Journal of Medicine, 31;378(22):2062-2065.
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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), we 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 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), we 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.\72\
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\72\ National Voluntary Consensus Standards for Care
Coordination 2012 Draft Technical Report. Available from https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=70600.
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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.\73\
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\73\ Ibid.
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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,\74\ approaches
developed by MedPAC, and proprietary approaches, such as the 3MTM
algorithm for potentially preventable
hospitalizations.75 76 77 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 post-acute care setting such
as home health.78 79
---------------------------------------------------------------------------
\74\ Prevention Quality Indicators Overview. Available at:
https://www.qualityindicators.ahrq.gov/modules/pqi_resources.aspx.
\75\ 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/.
\76\ National Quality Forum: Prevention Quality Indicators
Overview. 2008.
\77\ MedPAC: 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.
\78\ 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.
\79\ Walsh, 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.
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[[Page 62342]]
(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/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/PPH-TEP-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-Driven Groupings Model
(PDGM) 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
measures 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 multi-stakeholder 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.\80\
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\80\ https://www.cms.gov/files/document/2019muc-listclearancerpt.pdf.
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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 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 All-Cause
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.qualityforum.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 Post-Discharge 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.\81\
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\81\ Agency 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.
---------------------------------------------------------------------------
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)
[[Page 62343]]
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/Quality-Initiatives-Patient-Assessment-Instruments/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 \82\ and Potentially
Preventable Within Stay Readmission Measure for Inpatient
Rehabilitation Facilities \83\ measures.
---------------------------------------------------------------------------
\82\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
\83\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
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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/Quality-Initiatives-Patient-Assessment-Instruments/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:
Demographic characteristics (age, sex, original reason for
Medicare entitlement).
Care received during prior proximal hospitalization \84\
(if applicable) (including the length of the hospitalization and
principal diagnoses during the prior proximal hospitalization).
---------------------------------------------------------------------------
\84\ Prior proximal hospitalizations for this measure are
defined as inpatient stays within 30 days prior to home health
admission.
---------------------------------------------------------------------------
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 proposed 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/Quality-Initiatives-Patient-Assessment-Instruments/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,\85\ we proposed 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 proposed 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.
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\85\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.
---------------------------------------------------------------------------
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 proposed 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 claims-based
measures beginning with the CY 2023 HH QRP.
We invited public comments on this proposal.
Comment: Most commenters supported our proposal to Replace the
Acute Care Hospitalization During the First 60 Days of Home Health (NQF
#1071) 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.
Response: We thank commenters for their support of the proposal to
replace the Acute Care Hospitalization During the First 60 Days of Home
Health (NQF #1071) 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
[[Page 62344]]
measure. We regularly strive to improve domains of quality and this
policy seeks to improve how hospitalizations are addressed in home
health.
Comment: Some commenters supported the PPH measure replacement with
a condition that providers be given some time to adjust before it is
added to either the HH QRP or HHVBP program.
Response: We disagree with the commenters recommendation to be
given additional time to adjust under the HH QRP. We interpret the
comment to convey that finalization of this policy in the CY 2022 rule,
confidential feedback to providers in October 2022, and reporting
commencing no sooner than October 1, 2023, is too soon. We contend that
HHAs would have more than a year after finalization of this policy to
review their PPH measure scores and implement quality improvement
measures if needed.
At the present time, we only proposed the PPH measure under the HH
QRP. We will note that where possible, CMS does seek alignment across
our post-acute care quality programs.
Comment: A few commenters supported the PPH replacement of the ACH
and ED Use measures but had suggested modification to the PPH measure
specification, including the removal of the observation stays from the
numerator, addition of ED use to the numerator, and a strengthening of
the risk adjustment model for the measure. Commenters were concerned
with the launch of OASIS E and use of items associated with the HH
Patient-Driven Groupings Model (PDGM) implemented January 2020 and
concurrent with the development of the PPH measure.
Response: With respect to modifications of the PPH measure, we
continually seek improvement to the specifications of measures and
anticipates a robust risk adjustment approach consistent with other
claims-based outcome measures currently under the HH QRP. As is our
practice, we will assess the appropriateness of inclusion of any new
assessment items available for use to improve risk adjustment as those
items are available. We have also assessed the importance of the
inclusion of observation stays in the PPH measure and do believe that
addressing preventable observation stays as well as inpatient stays are
important aspects of quality improvement based on clinical research
showing the trends of observation stays in inpatient settings and an
improvement on addressing only ED use in the numerator. Observation
stays are an important form of hospitalization and in the process of
assessing for observation stays, ED use is also captured. As with other
claims-based measures in the HH QRP, CMS will assess the impact of PDGM
implementation on measure specification and update measure details as
necessary.
Comment: Some commenters suggested that it is important for the PPH
measure to obtain NQF endorsement if the measure is to be added to the
HH QRP.
Response: We intend to submit the PPH measure for NQF endorsement.
Final Decision: After careful consideration of the public comments
we received, we are finalizing the replacement of the Acute Care
Hospital 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) measures 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.
c. 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; 2 years after this date
is January 1, 2021.
We proposed 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.
As required by section 1899B(g)(2) of the Act, to date CMS has made
these two measures available for review by HHAs 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, 3 months in advance of the inaugural display of
these measures on Care Compare.
We invited public comments on our proposed schedule to publicly
display these measures.
Comment: A few commenters requested clarification regarding what
could be considered a major injury resulting from a fall for the
Percent of Residents Experiencing One or More Major Falls with Injury
measure.
Response: We refer readers to the measure details outlined in the
CY 2018 HH PPS final rule (82 FR 51727 through 51730) for the Percent
of Residents Experiencing One or More Major Falls with Injury measure.
Final Decision: We are finalizing our proposal to publicly report
the Percent
[[Page 62345]]
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.
d. 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 1 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.\86\ 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.
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\86\ https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.
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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.\87\ 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.88 89 90 91
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\87\ https://www.healthaffairs.org/do/10.1377/hblog20201214.543463/full/.
\88\ https://www.hartfordbusiness.com/article/demand-for-home-health-care-surges-amid-covid-19-shifting-industry-landscape.
\89\ https://www.forbes.com/sites/sethjoseph/2020/08/05/home-health-care-is-a-bright-light-during-covid-19-with-an-even-brighter-future/?sh=2bfa2c513891.
\90\ https://www.wsj.com/articles/demand-for-in-home-care-rises-during-coronavirus-11588003076.
\91\ https://www.csbj.com/premier/businessnews/healthcare/covid-19-boosts-demand-for-home-health-care/article_c65d2b4e-3b17-11eb-a46e-97a2079b065f.html.
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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.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government).
3. Collection of 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 proposed 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 2-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
[[Page 62346]]
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 data that includes
addressing SDOH provides information that is expected to improve
quality of care for all. Consequently, we proposed 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 proposed 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 proposed 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 proposed 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 invited public comment on these proposals.
Comment: Most commenters supported our plan to establishing the
OASIS-E effective January 1, 2023 for the corresponding collection of
transfer and standardized patient data elements on the assessment tool.
Response: We thank commenters for their support.
Comment: Many commenters who were supportive of this proposal
requested that CMS consider the overall burden associated with OASIS-E
and to consider ways to mitigate the burden of reporting additional
OASIS-E items.
Response: We appreciate the importance of avoiding unnecessary
burden on HHAs and will continue to evaluate and consider any burden
associated with changes to the OASIS. We have taken into consideration
any new burden that our proposals might place on HHAs outlined in the
CY 2020 HH PPS final rule (84 FR 60566 through 60608).
Comment: Some commenters did not support the launch of OASIS-E in
January 1, 2023, citing the ongoing PHE and the additional burdens an
assessment tool launch would incur.
Response: We considered the ongoing impact of the PHE, provisions
implemented to support HHAs, in managing the PHE impacts, and
management of care provision since the start of the PHE (86 FR 35955
through 35955). Based on a review of the current impacts of the PHE on
HHAs nationally, we believe HHAs are well-positioned to successfully
implement OASIS-E beginning January 1, 2023.
Comment: Most commenters supported the collection of the Transfer
of Health Information to Provider Post-Acute Care and Transfer of
Health Information to Patient Post-Acute Care measures and certain
standardized patient assessment data elements beginning in January 1,
2023, highlighting the importance of these measures and items in
support of CMS quality efforts.
Response: We thank the commenters for their support of this
proposal and outcome of these data collection efforts to further build
on our ability to assess quality in HHAs.
Comment: Some commenters did not support our proposal to revise the
compliance date for the Standardized Patient Assessment Data Elements
while the PHE continued, and suggested that CMS defer collection until
after the conclusion of the PHE.
Response: We considered the ongoing impact of the PHE, provisions
implemented to support providers, including HHAs, in managing the PHE
impacts and HHA management of care provision since the start of the
PHE. Based on a review of the current impacts of the PHE on HHAs
nationally, we believe HHAs are well-positioned to successfully collect
these Standardized Patient Assessment Data Elements.
Final Decision: After consideration of the public comments, we are
finalizing our proposal that HHAs will 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 are finalizing
that HHAs will begin collecting data on the two TOH measures beginning
with discharges and transfers on January 1, 2023 on the OASIS-E. We are
also finalizing that HHAs will collect 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.
D. 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 the statutory authority granted the
Secretary 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 (and associated provisions in Title XI) to ensure that
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 have issued HHAs a variety of regulatory waivers. 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
Sec. 484.80(h)(1) and (2) that we believe will be appropriate as
permanent policy. These proposed changes and their respective
background information are discussed in detail below.
In addition, in order to implement section 115 of Division CC of
the CAA 2021, we proposed to modify the
[[Page 62347]]
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. Regulatory Provisions
We proposed 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 Sec.
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 on-site
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 Sec. 484.80(g). However, we believe it is important to permit HHAs
to complete this assessment virtually, in the rare circumstance that an
onsite visit cannot be coordinated within the 14-day time period.
We proposed 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 proposed to revise the language at Sec.
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 Sec. 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 proposed to 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 could
not exceed 2 virtual supervisory 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 noted an area of concern
during the 14-day supervisory assessment, the supervising individual
would have to make an on-site in-person visit to the location where the
patient was receiving care while the aide performed care, in order to
observe and assess the aide, as required at Sec. 484.80(h)(1)(ii) and
(iii).
While we proposed 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 on-site in-person visit
might 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 did not propose changes to the requirements for annual aide
assessments at Sec. 484.80(h)(1)(iii). In addition to the regularly-
scheduled 14-day supervisory assessment and as-needed 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 also proposed revisions to the supervisory assessment
requirements for aides providing care to patients who are not receiving
skilled care services. At Sec. 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 proposed 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 proposed 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
[[Page 62348]]
(direct) observation of each aide 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 the assessment
found deficiencies in the aide's performance, the agency would have to
conduct (and the home health aide would have to 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 proposed to add
a new requirement to 42 CFR 484.80(h)(2) that would require the RN to
make a semi-annual 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 in-person
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, Sec. 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 proposed to maintain this requirement at Sec. 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 requested public comment on our proposed changes to allow
virtual supervisory assessments of home health aides for patients
receiving skilled care at Sec. 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 welcomed comments from patients and caregivers who have
experienced virtual supervisory assessments of home health aides during
the PHE.
Comment: Some commenters recommended that CMS eliminate the 14-day
home health supervisory visit entirely. However, these commenters did
not provide rationale for this recommendation.
Response: We did not propose any changes to the 14-day home health
aide supervisory visit at Sec. 484.80(h)(1) other than permitting this
visit to be conducted virtually, via interactive telecommunications
systems, in the rare circumstance that an onsite visit cannot be
coordinated within the 14-day time period. The supervisory visits are
conducted when patients are receiving aide services in conjunction with
skilled home health services such as skilled nursing, occupational
therapy, physical therapy, and speech language pathology services.
These visits are the opportunity to verify the aide is following the
patient's plan of care; effectively communicating with the patient;
demonstrating competency with assigned tasks; complying with infection
prevention and control policies and procedures; reporting changes in
the patient's condition; and honoring patient rights. We believe these
visits are an important component to ensuring that aides furnish care
in a safe and effective manner.
Comment: Commenters overwhelming supported the proposed change to
permit the 14-day home health aide supervisory visit to be conducted
virtually, via interactive telecommunications systems, in the rare
circumstance that an onsite visit cannot be coordinated within the 14-
day time period. However, some of these commenters expressed concerns
regarding the frequency that HHAs would be permitted to exercise this
flexibility. Commenters indicated that it would be difficult, if not
impossible, for home health agencies to track these visits at the
agency level to ensure compliance. Many commenters recommended that CMS
apply the frequency so that the virtual visits would be permissible at
the patient-level rather than the agency-level. Some comments
recommended a specific frequency for each patient, such as one or two
per patient per 60-day episode.
Response: In proposing the limit on HHA utilization of virtual home
health aide supervisory visits at Sec. 484.80(h)(1), we sought to
balance the need for in-person visits with flexibility for unplanned
circumstances that may prevent an HHA from complying with this
requirement. However, many commenters have indicated that the
requirement, as proposed, would be difficult to track and monitor
making it ineffective, especially for large agencies. We do believe it
important to have this flexibility without creating additional burden
for agencies. We are therefore revising the requirement to implement
the change at the patient-level. However, we believe the in-person
visits are an important component to ensuring that aides furnish care
in a safe and effective manner. Therefore, we intend to limit this
virtual nurse aide supervisory visit to one per patient per 60-day
episode and only in the rare circumstance, from an unplanned
occurrence, that an onsite visit cannot be coordinated within the 14-
day time period. In our proposed rule, we stated such occurrences may
be from items such as, but not limited to, severe weather, a patient
requesting to change the date of the scheduled visit, or unexpected
staff illness or absence on the planned day for the visit. We believe
these examples still apply. However, if the HHA finds it necessary to
utilize this virtual option, the HHA will need to document in the
patients record the rationale for the virtual visit.
Comment: Several commenters recommended conducting all aide
supervisory visits virtually. A commenter recommended removing any
artificial cap the number and letting the HHA decide on which visits
would be appropriate to be conducted in-person and which would be
appropriate for virtual supervision.
Response: We believe the home health services 14-day supervisory
visit for aide services at Sec. 484.80(h)(1) should be conducted in-
person to ensure that patients are receiving care in a safe and
effective manner. Replacing this requirement with completely virtual
supervisory visits would reduce oversight of key aspects of care
provided by aides.
Comment: A commenter opposed the changes in home health aide
supervisory visits permitting a virtual visit in rare circumstances at
Sec. 484.80(h)(1), stating that the proposed change is inconsistent
with the provision of quality care and limits the ability of HHAs to
assess aides. This commenter suggested more evaluation and study be
conducted before making the change permanent. Another commenter
indicated that virtual visits are subject to numerous problems that may
hinder effective home health aide supervision. This commenter indicated
that there are frequently technical and economic barriers to virtual
visits. They also indicated that many patients prefer in-person visits
and that these forge a strong relationship with patients. Finally, the
commenter indicated that
[[Page 62349]]
virtual aide supervision would hinder the nurse from assessing for
changes in the patient's condition that would otherwise be detected
with an in-person visit.
Response: We appreciate these comments and the concern for patient
safety and quality of care. However, we are proposed this flexibility
to facilitate compliance with this requirement in the rare circumstance
that an HHA cannot complete the requirement due to unplanned
occurrences. Therefore, we expect HHAs to exercise this provision
rarely and not more than once per patient every 60-day episode of care.
Additionally, we do not expect to see this provision exercised for
every patient during every 60-day period. We expect that home health
surveyors would investigate such instances while conducting inspection
of the home agency and seek supporting narrative in the home health
patient record describing why a virtual visit was conducted in each
instance. In instances when barriers prevent a virtual supervisory
visit via a 2-way audio-visual telecommunications system, such as no
internet service or the patient is unable to utilize the
telecommunications system, the agency would be non-compliant with the
supervisory visit requirement and would need to complete an in-person
visit as soon as possible. Finally, the primary purpose of the aide
supervisory visit at Sec. 484.80(h)(1) is to assess the aide care plan
and services provided by the aide rather than an assessment of the
patient that occurs during the skilled visit. The discussion that
occurs between the nurse and the patient during this visit allows for
open dialogue regarding the aide's services outlined in the plan of
care and services carried out by the aide. If in the conversation the
nurse notes a potential issue with the aide's care, a competency skills
check will be triggered. Therefore, we believe the type and frequency
of patient visits provided the necessary supervision to support quality
care.
Comment: Several commenters recommended CMS remove the 2-way audio-
visual requirement as part of the proposed virtual aide supervisory
visit.
Response: We appreciate the requests to remove the proposed
language regarding 2-way audio-visual requirement as part of the
virtual aide supervisory visit. While we understand some patients may
not have access to the internet or the ability to use such technology;
we believe it is imperative for the clinician to be able to see the
patient during these 2-way audio-visual communications. Utilizing only
the phone for audio communications does not allow the clinician to
visualize the patient and assess areas such as wounds, mobility and
circulation. In regards to the patient using audio-visual technology,
being able to visualize the clinician they are speaking with assists in
fostering and maintaining the patient and clinician relationship. If
the patient does not have access to 2-way audio-visual technology, the
agency would be non-compliant with the supervisory visit requirement
and would need to complete an in-person visit. Therefore, we are
finalizing the use of 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 1 virtual supervisory
assessment per patient in a 60-day period, regardless of the number of
aides or patients associated with a given HHA.
Comment: Many commenters were supportive of the proposed provision
at Sec. 484.80(h)(2) revising the supervisory assessment requirements
for aides providing care to patients who are not receiving skilled care
services, indicating that the change would significantly reduce burden
for HHAs. These commenters stated that the on-site and virtual visits
would provide the appropriate balance of supervision for this
requirement. However, these same commenters also recommended that CMS
monitor the feasibility for HHAs to conduct a semi-annual onsite, aide
present, supervisory visit on their non-skilled patients. They stated
that they have concerns with the logistics of conducting a semi-annual
onsite visit, aide present, for all home health aides.
Response: We appreciate the opportunity to clarify this
requirement. CMS has previously received feedback that the prior
requirement of an onsite visit every 60 days for each aide providing
services to non-skilled patients was overly burdensome for the patient
and the HHA if multiple home health aides provide care to the same
patient. Retaining the 60-day frequency but changing the requirement
for the in-person direct observation of the aide to biannually will
decrease the amount of times the HHA must observe each aide in-person.
For instance, over the course of 180 days, an HHA providing aide
services to a patient receiving care from three aides would be required
to coordinate and provide a total of nine supervisor visits with both
the nurse and the aide present. Under the new requirement, the HHA
would still be required to conduct nine supervisory visits but would
only have to coordinate as few as three in-person supervisory with both
the nurse and the aide present. Although this will require some
coordination and planning on the part of the HHA, we believe this will
provide for more efficient planning and scheduling for HHAs from the
prior requirements while still maintaining oversight to ensure adequate
supervision of the services provided.
Comment: A commenter opposed the proposed change to aide
supervision at Sec. 484.80(h)(2) for patients that are not receiving
skilled services, permitting this supervisor visit to be conducted
without the aide present. The commenter suggested that more evaluation
and study be conducted before making the change permanent. Another
commenter stated the proposed change results in the RN's assessment and
observation of a home health aide occurring three times less
frequently. The commenter stated that lack of frequent direct
assessment of the home health aide by an RN could jeopardize a
patient's health, safety, and ability to recover their highest level of
function.
Response: We appreciate these comments regarding the health and
safety of patients and concerns for ensuring home health aides provide
quality care. An important component to addressing these concerns is
ensuring that home health aides enter the workforce meeting minimum
qualifications that includes training and competency evaluation. We
have extensive requirements specifying the content and duration of home
health aide classroom and supervised practical training at Sec.
484.80(b), competency evaluation requirements at Sec. 484.80(c),
annual in-service training requirement at Sec. 484.80(d),
qualifications for instructors conducting classroom and supervised
practical training at Sec. 484.80(e), and eligibility requirements for
training and competency evaluation organizations at Sec. 484.80(g).
These aspects are critical components to ensuring the aide workforce is
adequately trained and qualified to provide home health aide services.
Aides are assigned to specific patients with written care instructions
for the services they will be providing. Additionally, they will be
provided periodic supervision by one of the HHA skilled professionals.
Therefore, we do not believe the extensive direct supervision
requirements for patients receiving non-skilled services only are
necessary and believe these have been overly burdensome for HHAs.
Regardless, we do believe that direct
[[Page 62350]]
observation of the aide while providing services is an important
component of supervision. However, we also believe that patients should
also have the opportunity to speak with the skilled professional
without the aide present to provide the patient the opportunity to
speak freely about any concerns they may have. We believe this is also
an important aspect of the supervision component in hearing directly
from the patient where some patients may be more reserved in sharing
concerns if the aide were present. However, we do acknowledge the
commenters concerns regarding the frequency of oversight that has been
proposed. We had proposed that each aide receive one direct observation
every 6 months for one non-skilled patients for which the aide is
providing services. We are revising this requirement so that the aide
receives a direct observation every 6 months for each patient to whom
the aide is providing services. This is a significant decrease in the
planning and coordination for HHAs from the previous requirement of a
direct observation supervisory visit for each patient every 60 days.
However, it provides an increase in supervisory visits over what was
originally proposed. We believe this strikes a balance is reducing
burden while providing necessary direct observation in ensuring the
health and safety of patients receiving home health aide services.
Comment: Several commenters requested clarification on the skills
that would be considered related when a deficient skill was assessed
during an aide supervisory visit. While other commenters requested
additional examples, to promote consistency for applying this
requirement and that CMS align the requirements with the hospice
requirements.
Response: We appreciate the commenters support on this issue and
the request for clarification. 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 believe this is
not a one size fits all in determining what is related. Every patient
and aide presents a unique dynamic. Ultimately it is the supervising
nurse's clinical judgement on a case by case basis to determine what
additional competency areas are related.
Final Decision: After consideration of the public comments
received, we are finalizing the 14-day aide supervisor visit at Sec.
484.80(h)(1) with modification. Based on public comment, we intend to
apply the changes at patient-level rather than the agency-level.
Therefore, we will permit the one virtual supervisory visit per patient
per 60-day episode. This visit must only be done in rare instances for
circumstances outside the HHA's control and must have documentation in
the medical record detailing such circumstances. At Sec. 484.80(h)(2)
we are finalizing the supervisory visit requirements for non-skilled
patients with modification. We are modifying the semi-annual onsite
visit to require that this visit be conducted on ``each'' patient the
aide is providing services to rather than ``a'' patient. Lastly, after
consideration of the public comments we received at Sec. 484.80(h)(3),
we are finalizing the assessment of deficient skills as proposed.
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 proposed to conforming regulation
text changes at Sec. 484.55(a)(2) and (b)(3), respectively to
implement this provision.
Currently, the requirement at Sec. 484.55(a)(2) provide that 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 professional. We proposed to add new
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. This is necessary
because a need for occupational therapy alone cannot 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
Sec. 484.55(b)(3), we proposed 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).
Comment: Many commenters were appreciative of the change proposing
to permit occupational therapists to conduct the initial assessment
visit and the comprehensive assessment for home health services but
questioned why occupational therapy alone does not establish program
eligibility. A commenter stated that occupational therapists address a
wide range of patient populations and diagnoses with a focus on
individual patient goals. The commenter stated that occupational
therapy is often the most appropriate discipline to assess and evaluate
the patient in their home environment and provide interventions to
ensure that the patient is able to safely perform the activities and
routines they need and want to do while in their home. This commenter
requested that CMS support any Federal legislation to make occupational
therapy a qualifying service. Another commenter questioned why CMS did
not modify the Social Security Act to allow the need for occupational
therapy to establish eligibility for home health services.
Response: We appreciate the commenters' support. The eligibility
requirements for the coverage of home health services is specified at
sections 1814(a)(2)(c) and 1835(a)(2)(A) of the Act. The statute
permits payment for
[[Page 62351]]
home health services when a patient is confined to a home and has a
need for skilled nursing care (other than solely venipuncture for the
purpose of obtaining a blood sample) on an intermittent basis or
physical or speech therapy. Additionally, payment may also be made when
a patient no longer has a need for these services but continues to need
occupational therapy. Therefore, occupational therapy alone does not
establish initial program eligibility. CMS does not have the statutory
authority to permit occupational therapy to be a qualifying service. An
act of Congress would be needed to change the statute.
Comment: Many commenters recommended that all rehabilitation
therapists (occupational therapists, physical therapist, and speech
language pathologists) be permitted to conduct the initial assessment
visit and the comprehensive assessment for home health services, even
when ordered concurrently with skilled nursing services. Commenters
stated that this change would facilitate more timely access to home
health services.
Response: The requirements for conducting the initial assessment
visit and the comprehensive assessment for home health services are
based on sections 1814(a)(2)(c) and 1835(a)(2)(A) of the Act regarding
eligibility and payment for home health services. The requirements for
these assessments are based on the professional disciplines that will
be involved in, and coordinating, care for the patient. Therefore, when
nursing is assigned to the case, it is likely the patient will have a
greater need for nursing services than other services so we believe
that skilled nurses should conduct the initial assessment visit and
initiate the comprehensive assessment. In therapy-only cases, it would
be appropriate for the therapist to conduct the initial assessment
visit and the comprehensive assessment. We did not propose changes
beyond those authorized under Division CC, Section 115 of The
Consolidated Appropriations Act of 2021, but will consider this issue
in future rulemaking.
Comment: A commenter sought clarification on the sequence of
services between qualifying services and other Medicare covered
services, specifically occupational therapy. The commenter requested
clarification on whether or not the sequencing of disciplines providing
services, as described in the Medicare Benefits Policy Manual (CMS Pub
100-02), Chapter 7, Section 30.2.11, would be irrelevant following the
proposed changes permitting occupational therapists to conduct the
initial assessment visit and comprehensive assessment. The commenter
wanted to know if occupational therapists would be able to conduct
these tasks before other therapy disciplines.
Response: We appreciate the opportunity to clarify this policy. The
change implementing Division CC, Section 115 of The Consolidated
Appropriations Act of 2021 permits occupational therapists to conduct
the initial assessment visit and comprehensive assessment in ``therapy-
only'' cases. This is when occupational therapy is on the home health
plan of care along with physical therapy and/or speech therapy, but
skilled nursing services are not initially on the plan of care. If the
physician-ordered plan of care contains orders for a qualifying service
other than skilled nursing services (physical therapy and/or speech
language pathology services), then occupational therapy may conduct the
initial assessment visit and comprehensive assessment prior to the
visits from other therapy disciplines; however, the occupational
therapist will be required to determine eligibility for the Medicare
home health benefit, including homebound status, as part of the initial
assessment and comprehensive assessment. In ``therapy-only'' cases for
Medicare patients, the sequence in the delivery of the type of therapy
is irrelevant as long as the need for a qualifying service is
established during the initial assessment visit and when the
comprehensive assessment of the patient is completed in accordance with
the regulations at Sec. 484.55.
Final Decision: After consideration of the public comments we
received, we are finalizing this provision as proposed.
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. We sought information about the adequacy
of aide staffing and solicited 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 to 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.
Comment: Several commenters provided feedback regarding the
adequacy of aide staffing. Some of these commenters stated they are
experiencing a severe shortage of nurses. While other commenters stated
they are experiencing shortages in all disciplines, RN, PT, OT, ST,
social worker, and aide staffing. A commenter noted that there had been
a 50 percent decrease in the number of aides and professional staff
applying for positions. The commenter also stated that ``the pandemic
has caused many professionals to change course to stay at home with
families, look for remote work opportunities, and remain employed in
facilities where they feel safer due to the controlled environment''.
Commenters also stated that field safety has become more of concern
because of recent social unrest and the pandemic leaving some of our
most vulnerable patient service areas under[hyphen]staffed. A commenter
stated that ``agencies are increasingly not staffing for home health
aides (current COVID-related circumstances aside). Instead of providing
home health aides, agencies refer patients to their non-Medicare,
private pay ``affiliates'' for related services, or cost-shift home
health aides for patients dually enrolled in Medicare and Medicaid to
Medicaid. In the case of Medicare Advantage, many plans simply do not
allow home health aide services to be delivered. Denying access to
Medicare-covered home health aides for help with activities of daily
living as critical as bathing, toileting, grooming, skin care, walking,
transferring, and assistance with self-administered medications, puts
enrollees at risk of being hospitalized or entering a nursing home
because they do not get the support they need to stay safely at home.
These practices are costly for Medicare and detrimental to the
enrollee's health and wellbeing''. Other commenters suggested that CMS
should ensure that Medicare home health agencies serving beneficiaries
who require Medicare-covered home health aide services meet the
statutorily defined limit of 28 to 35 hours a week and that robust
oversight is necessary to ensure that agencies provide necessary care.
Response: We appreciate the robust comments in response to the
adequacy of aide staffing questions. Ensuring home health workforce
staffing adequacy is an important concern and we take reported
shortages seriously.
[[Page 62352]]
We will continue to review the information received as we consider ways
to ensure that aide services are meeting the patient's needs as such
services are a critical part in maintaining safe, quality care.
d. Technical Correction (Sec. 484.50(d)(5))
In the May 2020 COVID-19 IFC (85 FR 27550), we amended the home
health regulations by adding ``or allowed practitioner(s)'' to the
CoPs.
Comment: A commenter noted that the ``allowed practitioner''
language is missing from Sec. 484.50(d)(5).
Response: We did not propose this change in the proposed rule.
However, we believe making this change in the final rule constitutes a
minor technical change to our regulation, which conforms our rule to
the statutory language. Therefore, we are making the suggested
correction to Sec. 484.50(d)(5).
V. Home Infusion Therapy Services: Annual Payment Updates for CY 2022
A. Home Infusion Therapy Payment Categories
Section 5012 of the 21\st\ 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, we 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 did not propose 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).\92\ 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).\93\ 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) \94\ 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.
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\92\ Billing for Home Infusion Therapy Services on or After
January 1, 2021 (MM11880). https://www.cms.gov/files/document/mm11880.pdf.
\93\ Local Coverage Determination (LCD): External Infusion Pumps
(L33794). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794.
\94\ Local Coverage Determination (LCD): External Infusion Pumps
(L33794). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794.
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Section 1861(iii)(3)(C) of the Act defines a home infusion drug as
a parenteral drug or biological administered intravenously or
subcutaneously for an administration period of 15 minutes or more, in
the home of an individual through a pump that is an item of DME. Such
term does not include the following: (1) Insulin pump systems; and (2)
a self-administered drug or biological on a self-administered drug
(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
self-administered 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[supreg], 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[supreg] 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[supreg] 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
[[Page 62353]]
to the administration of Hizentra[supreg] are covered under payment
category 2 under both the temporary transitional payment from 2019 to
2020, and the permanent benefit beginning January 1, 2021. The DME MACs
maintain and update the list of home infusion drugs and their
respective payment categories for purposes of the home infusion therapy
services benefit under the DME LCD for External Infusion Pumps
(L33794). For these routine updates, we 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 reminded 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 (Pub. L. 113-93) (PAMA 2014).
The CY 2022 PFS proposed GAFs are available on the PFS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched.
In the CY 2020 HH PPS final rule with comment period (84 FR 60628),
we stated that the application of the GAF would be budget-neutral,
therefore there is no overall cost impact by applying a budget-
neutrality factor. We proposed 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. We did not receive any comments on the proposal to use the CY
2022 GAFs to wage adjust home infusion therapy payments nor the
proposal to continue the application of the GAF standardization factor.
Final Decision: We are finalizing the proposal to use the CY 2022
GAFs to wage adjust home infusion therapy payments for CY 2022. We are
also finalizing our proposal to continue the apply a GAF budget
neutrality factor to home infusion therapy payments whenever there are
changes to the GAFs in order to eliminate the aggregate effect of
variations in the GAFS. The CY 2022 GAF standardization factor that
will be used in updating the payment amounts for CY 2022 will be
1.0001. The final CY 2022 GAF values will be posted as an addendum on
the PFS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/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 webpage.\95\
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\95\ Home Infusion Therapy Services Billing and Rates. https://www.cms.gov/medicare/home-infusion-therapy-services/billing-and-rates.
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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 Consumer Price
Index for all Urban Consumers (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 1-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 in June of 2021 is 5.4
percent and the corresponding productivity adjustment is 0.3 percent.
Therefore, the final home infusion therapy payment rate update for CY
2022 is 5.1 percent.
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 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 reminded
stakeholders that effective January 1, 2021 there were changes to the
office/outpatient E/M visit code set (CPT codes 99201,99215) 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.ama-assn.org/practice-management/cpt/cpt-evaluation-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
[[Page 62354]]
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.
Division N, section 101 of CAA 2021 added section 1848(t)(1) of the
Act applied a 3.75 percent increase in PFS payment amounts only for CY
2021.\96\ 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 1.33 percent. We
noted 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 1.33 percent
decrease for all subsequent visit payment amounts.
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\96\ Medicare Learning Network Connects ``Special Edition:
Physician Fee Schedule Update'' (Jan 7, 2021). https://www.cms.gov/files/document/2021-01-07-mlnc-se.pdf.
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In the CY 2021 HH PPS final rule (85 FR 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 the preceding year reduced by a productivity adjustment beginning in
2022. Therefore, we are 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 proposed to maintain the 20 percent
increase calculated for the initial home infusion therapy service
visits and the 1.33 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 invited 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. We did not receive
any comments on our proposal to maintain the percentages for the
initial and subsequent visits.
[[Page 62355]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.053
Final Decision: We are finalizing the proposal to maintain the 20
percent increase calculated for the initial home infusion therapy
service visits and the 1.33 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.
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.\97\ For CY 2022, we 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 the CY 2022 home infusion therapy services payment amounts.
Table E2 shows the CY 2021 unadjusted payment rates after removing the
3.75 percent increase. The unadjusted CY 2021 rates will be updated for
CY 2022 in accordance with section 1834(u)(3) of the Act using the 5.4
percentage increase in the CPI-U for the 12-month period ending in June
of 2021 reduced by the productivity adjustment of 0.3 percent, which
results in a 5.1 percent increase.
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\97\ Medicare Learning Network Connects ``Special Edition:
Physician Fee Schedule Update'' (January 7, 2021). https://www.cms.gov/files/document/2021-01-07-mlnc-se.pdf.
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The unadjusted CY 2021 national home infusion therapy rates are
located in Table 35. The final CY 2022 national home infusion therapy
services 5-hour payment amounts are located in Table 36.
[GRAPHIC] [TIFF OMITTED] TR09NO21.054
[[Page 62356]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.055
The geographically adjusted home infusion therapy services payment
rates will be released in a forthcoming change request CR and posted on
the Home Infusion Therapy Services Billing and Rates webpage.\98\ 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). While we did not include CY
2022 payment amounts in the proposed rule, we did not receive comments
on the approach used to calculate these rates.
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\98\ Home Infusion Therapy Services Billing and Rates. https://www.cms.gov/medicare/home-infusion-therapy-services/billing-and-rates.
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Final Decision: The unadjusted CY 2021 rates will be updated for CY
2022 in accordance with section 1834(u)(3) of the Act using the 5.4
percentage increase in the CPI-U for the 12-month period ending in June
of 2021 reduced by the productivity adjustment of 0.3 percentage point,
which results in a 5.1 percent increase.
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 CMS 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 Sec. Sec. 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 Sec. 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 Internet-based Provider Enrollment, Chain,
and Ownership System (PECOS) process (SORN: 09-70-0532, Provider
Enrollment, Chain, and Ownership System) collects important information
about the provider or supplier; such data includes, but is not limited
to, general identifying information (for example, legal business name),
licensure and/or certification data, and practice locations. After
receiving the provider's or supplier's initial enrollment application,
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.
The previously-referenced regulations we have issued since 2006
clarified and strengthened certain components of the enrollment
process. Moreover, they enabled 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 final
rule, we proposed several changes to our existing provider enrollment
regulations in the proposed rule.
2. Legal Authorities
There were 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. Provisions
1. Effective Dates
We proposed to codify in regulation certain effective date
practices discussed in CMS Publication 100-08, Program Integrity Manual
(PIM) (or in other subregulatory guidance). We believed that
incorporating these topics into 42 CFR part 424 would furnish needed
clarification and allow the
[[Page 62357]]
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, Sec. 424.521(a) states
that the seven aforementioned 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.
Under the applicable PIM guidance, CMS had applied the effective
date policies in Sec. Sec. 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.
We proposed to add these nine supplier types to the scope of
Sec. Sec. 424.520(d) and 424.521(a). Our specific regulatory changes
were as follows:
First, we proposed in the title and opening paragraph of Sec.
424.520(d) to replace the current enumeration of all seven provider and
supplier types therein with a simpler, more generic reference to the
``provider and supplier types'' identified in paragraph (d)(2). This
proposed classification would include the aforementioned seven provider
and supplier types as well as the nine we proposed to add to Sec.
424.520(d). Consistent with this change, we further proposed to:
Redesignate existing Sec. 424.520(d)(1) and (2) as,
respectively, new Sec. 424.520(d)(1)(i) and (ii).
List the 16 previously referenced provider and supplier
types as new Sec. 424.520(d)(2)(i) through (xvi).
Second, and similar to our change to Sec. 424.520(d), we proposed
to revise the title and opening language of Sec. 424.521 to broadly
encapsulate the 16 affected provider and supplier types (for example,
the title would list them as ``certain provider and supplier types'')
rather than to individually list all 16 of them in the title and
opening paragraph. As part of this, we also proposed to--
Redesignate existing Sec. 424.521(a)(1) and (2) as,
respectively, new Sec. 424.521(a)(1)(i) and (ii); and
List the 16 previously discussed provider and supplier
types as new Sec. 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 Sec. 424.80. Under the applicable PIM guidance, CMS
applied the basic principles of Sec. Sec. 424.520(d) and 424.521(a) to
Form CMS-855R reassignments when establishing the effective date of the
latter. To codify this in regulation, we proposed to add a new Sec.
424.522, the title of which would state: ``Additional effective
dates.'' Paragraph (a) of Sec. 424.522 would specify that a
reassignment of benefits under Sec. 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 Sec. 424.507, a physician or other eligible professional (as
that term is defined in Sec. 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 a 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. In this scenario, he or
she will 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.
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
incorporate this in regulation, we proposed to state in new Sec.
424.522(b) that 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.
c. Comments on Effective Date Proposals
We did not receive specific comments on the foregoing effective
date proposals and are therefore finalizing them as proposed and
without modification.
2. Rejections and Returns
a. Background and Distinction
Per Sec. 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
Sec. 424.502) does not submit the application fee (in accordance with
Sec. 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 return of provider enrollment applications, too, is discussed
in the PIM. In general, an application has been returned when one of
the return
[[Page 62358]]
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.
As there has been uncertainty within the provider community
regarding the difference between application rejections and returns as
well as the grounds for both actions, we proposed to revise Sec.
424.525 and to add a new Sec. 424.526.
b. Rejection and Return Policies
(1) Rejections
The three previously discussed reasons in Sec. 424.525(a) for
rejecting an application are currently designated as, respectively,
paragraphs (a)(1), (2), and (3). We proposed to include the following
ten rejection scenarios (almost all of which had been identified as
reasons for rejection in the PIM) within the larger Sec. 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 paragraph (a)(1) (for instance, furnishing correct and
complete data) within the 30-day period stated therein. The scenarios
in question would be designated as Sec. 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 e-mail 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.)
Existing Sec. 424.525(b), (c), and (d) address various operational
aspects of our rejection policy. We did not propose to revise them.
However, and to clarify the scope of Sec. 424.525, we proposed in new
Sec. 424.525(e) that Sec. 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 Sec. 424.525(e)(1)
through (3). Concomitant with this change, we proposed to remove the
word ``prospective'' from Sec. 424.525(a)(1), (2), and (3) and (b).
This would clarify that these three rejection grounds apply to enrolled
providers and suppliers and not simply to prospective enrollees.
(2) Returns
We proposed in new Sec. 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 Sec.
424.526(a)(1) through (13)--
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
would 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 Sec. 424.535 or reapplication bar under Sec. 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 done
either of the following:
++ Not yet made a recommendation for approval concerning the
initial application, both applications may be returned in this
scenario.
++ Made a recommendation for approval concerning the initial
[[Page 62359]]
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 also proposed in Sec. 424.526 to explain certain operational
components of our return policy. First, we proposed in Sec. 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.) Second, we proposed to effectively duplicate proposed
Sec. 424.525(e) in new proposed Sec. 424.526(c) in order to clarify
the types of enrollment applications and transactions to which Sec.
424.526 would apply.
(3) Comments on Rejection and Return Proposals
We did not receive specific comments on the foregoing rejection and
return proposals and are therefore finalizing them as proposed and
without modification.
3. Deactivation
(a) Background
Regulatory policies regarding the provider enrollment concept of
deactivation are addressed in Sec. 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 Sec. 424.540. As stated in Sec. 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 Sec. 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 Sec. 424.540's requirements for reactivation.
There are currently three grounds for deactivation under Sec.
424.540(a), listed as, respectively, paragraphs (a)(1), (2), and (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 Sec. 424.515. (In
addition, Sec. 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, Sec. 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 proposed several changes to
Sec. 424.540 that we believed were necessary.
(b) Deactivation Grounds, Deactivation Effective Dates, and
Reactivations
First, existing Sec. 424.540(a) contains an opening clause
followed by the three existing deactivation reasons, codified as
paragraphs (a)(1), (2), and (3). We proposed to add several new
deactivation grounds as paragraphs (a)(4) through (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 Sec. 424.550(b)(1).
Second, we proposed to revise Sec. 424.540(b)(1) to state that 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 title 42.
Third, and consistent with existing policy, we proposed in new
paragraph (d)(1)(i) to specify that, except as provided in Sec.
424.540(d)(1)(ii), the effective date of a deactivation is the date on
which the deactivation is imposed. In paragraph (d)(1)(ii), we proposed
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 Sec. 424.540(a)(2), (3), and (4), the
effective date would be 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 Sec. 424.540(a)(5), the date on which
the provider's or supplier's practice location became non-operational
or otherwise invalid.
++ For deactivation reason Sec. 424.540(a)(6), the date of death
of the provider or supplier.
++ For deactivation reason Sec. 424.540(a)(7), the date on which
the provider or supplier voluntarily withdrew from Medicare.
++ For deactivation reason Sec. 424.540(a)(8), the date of the
sale.
(c) Payment Prohibition
We also proposed in new Sec. 424.540(e) that a provider or
supplier may not receive payment for services or items furnished while
deactivated under Sec. 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
believed 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 non-
adherence 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
[[Page 62360]]
items furnished while out of compliance. We stated that proposed Sec.
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 proposed three additional clarifications to the
deactivation provisions in Sec. 424.540.
First, the opening sentence of Sec. 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. We believed this sentence
was too restrictive in that it did not address other reasons for our
deactivation policy. Therefore, we proposed to delete it. (The existing
second sentence of Sec. 424.540(c) was to remain intact and comprise
the whole of revised paragraph (c).)
Second, and as alluded to previously, the concluding sentence of
existing Sec. 424.540(a)(2) states that changes in ownership or
control must be reported within 30 calendar days as specified in
Sec. Sec. 424.520(b) and 424.550(b). We proposed to clarify that our
existing deactivation authority under Sec. 424.540(a)(2) applies to
both the changes that must be reported within 90 days and those within
30 days. Thus, we proposed to delete the existing version of this
paragraph and stated 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
Title 42.
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 proposed to add it as new Sec.
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.
(e) Comments on Deactivation Proposals
We did not receive specific comments on the foregoing deactivation
proposals and are therefore finalizing them as proposed and without
modification.
4. HHA Capitalization
Under Sec. Sec. 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 MAC to verify compliance with the requirements
of Sec. Sec. 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, Sec. 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 Sec. 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 Sec. 489.28(d) or (e). To remedy this,
we proposed to insert the phrase ``(if the financial institution offers
such attestations)'' after the term ``financial institution'' as used
Sec. 489.28(d) and (e).
We did not receive specific comments on this proposal and are
therefore finalizing it as proposed and without modification.
5. 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.
Section Sec. 424.550(b) contains several exceptions to the
previously referenced requirement to enroll as a new HHA. One exception
(identified in Sec. 424.550(b)(2)(i)) is that the HHA has submitted 2
consecutive years of full cost reports. 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. To clarify this, we proposed to revise the first
sentence of Sec. 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 Sec. 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 Sec. 424.550(b)(2)(i), would remain intact.)
We did not receive specific comments on this proposal and are
therefore finalizing it as proposed and without modification.
C. Miscellaneous Comments
We received the following three comments from stakeholders
concerning our proposed enrollment provisions as a whole.
Comment: A few commenters expressed support for the codification
into regulation of the previously-discussed sub-regulatory guidance.
However, one of these commenters requested that CMS: (1) Update the
paper enrollment forms to mirror the PECOS system; and (2) explain when
paper forms are required instead of submission via Internet-based
PECOS.
Response: We appreciate the commenters' support for our proposed
codifications. However, we believe that the commenter's two requests
are outside the scope of this rule.
Comment: A commenter requested that CMS permit hospitals to update
their Form CMS-855A enrollment to furnish home infusion therapy (HIT)
and to provide durable medical equipment (DME) to support HIT. The
commenter did not believe that hospitals should have to separately
enroll as a HIT supplier or DME
[[Page 62361]]
supplier to provide these services and items.
Response: We appreciate this comment but believe it is outside the
scope of this rule.
VII. Survey and Enforcement Requirements for Hospice Programs
A. Background
Hospice care, as referenced in our regulations at Sec. 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 person-centered. 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 Sec. 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 Sec. 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 Sec. 418.3.
Under this definition, an 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.
As noted in Sec. 489.10(b), in order to be certified in the
Medicare program, hospice programs must comply with applicable civil
rights laws,\99\ 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.
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\99\ Hospices 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.
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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 we 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, we determine 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, 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 CMS-approved
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
[[Page 62362]]
and suppliers meet or exceed the Medicare conditions and practices for
approving.
The current regulations at Sec. 488.4 set forth the general
provisions for CMS-approved accreditation programs for providers and
suppliers. The requirements at Sec. 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. Regulatory Provisions
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 the CMS website in a manner that is
prominent, easily accessible, searchable, and presented in a 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 AOs 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 toll-free 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 CMS-based surveyor
training to AOs, and the requirement for AOs with CMS-approved 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 the proposed rule, we proposed 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 proposed 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 proposed to amend Sec. Sec. 488.2 and 488.28, where
appropriate, to include the reference to a hospice program. In
addition, we proposed to amend termination and appeal requirements in
42 CFR parts 489 and 498 based on the proposed enforcement remedies.
We received 35 timely pieces of correspondence from hospice
industry associations, patient advocacy organizations, AOs with hospice
programs, and individuals.
Comment: Multiple commenters expressed support for the steps
Congress and CMS are taking to ensure high-quality hospice care and
consistent hospice program survey process throughout the nation.
Response: We appreciate the support from the public and agree that
ensuring high-quality, safe care for all patients in Medicare-certified
hospice programs is paramount and that a consistent survey and
enforcement process will help ensure quality.
2. Subpart A--General Provisions
a. Statutory Basis (Sec. Sec. 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 and enforcement
procedures. We proposed to amend the requirement at Sec. Sec. 488.2
and at 498.1 to include this statutory reference to hospice program
services. We received no public comments on these provisions, and we
are finalizing the regulations at Sec. 488.2 and at Sec. 498.1 as
proposed.
b. Application and Re-Application Procedures for National Accrediting
Organizations (Sec. 488.5)
We proposed at Sec. 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.
[[Page 62363]]
Currently, the regulations under Sec. 488.5 do not require AOs to
utilize the same forms as SA surveyors when documenting survey findings
of noncompliance. Specifically, Sec. 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
\100\ is the legal, documentary basis for how SAs and CMS Federal
surveyors note findings of compliance or noncompliance (deficiencies)
resulting from an inspection of Medicare-participating providers and
suppliers. Our regulations at Sec. 488.18 require that SAs document
all deficiency findings on a statement of deficiencies, which is the
Form CMS-2567.
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\100\ CMS-2567 available at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS2567.pdf.
---------------------------------------------------------------------------
Additionally, Sec. Sec. 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).\101\ In
mid-2021, CMS began 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.
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\101\ iQIES is available at: https://iqies.cms.gov/.
---------------------------------------------------------------------------
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 (Sec. 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 CMS-approved hospice
program AOs must now develop a way to incorporate this form into their
data systems.
As required by Sec. 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 Sec. 488.5.
CMS is continuing to assess 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 the 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 sought 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 XI of this final rule.
We sought public comment on how AOs can customize their proprietary
systems to incorporate a version of the Form CMS-2567 and then submit
it to CMS via electronic data exchange.
Comment: Several commenters supported the requirement for AOs to
utilize the same forms as SA surveyors when documenting survey findings
of noncompliance and noted it will promote consistency and
standardization.
Response: We thank the public for their support and believe this is
one step to ensuring consistency and transparency for the survey
process.
Comment: Several commenters asked that CMS engage stakeholders when
revising the Form CMS-2567. A suggestion was also made that CMS create
and offer an electronic version of the form to all states and AOs.
Response: Given the timeline mandated by the CAA 2021 and the
timing of this final rule, CMS needed to quickly revise the existing
Form CMS-
[[Page 62364]]
2567 in order for AOs to integrate it into their documentation systems
for use. As required by the Paperwork Reduction Act of 1995 (PRA)
requirements, CMS posted public notice of the proposed form changes for
a 30-day comment period beginning July 13, 2021. 86 FR 36751. We
received one comment on the Form CMS-2567 which was outside the scope
of the information collection request. We made the necessary minimal
updates to the form, that were needed for AO use, which we described in
the proposed rule, 86 FR 35969, 35988, and in the public notice of
proposed form changes, 86 FR 35874. If CMS decides to make further
revisions to the form, it will go through public notice process again
as required by the PRA.
Additionally, as noted in the proposed rule discussion, CMS has
begun transitioning to the new software system on a program-specific
implementation schedule, starting with HHAs. While it may take several
years to fully transition all programs to the new technology platform,
SAs and AOs will have access to this system. The Form CMS-2567 is
currently generated electronically through the CMS software system and
will continue to be as we transition systems and provide additional
user access. As the rule notes, the requirement is for the inclusion of
a statement of deficiencies, which means the Form CMS-2567 or a
successor form. CMS will communicate with stakeholders if we move away
from the Form CMS-2567 to a different format.
Comment: A few commenters noted that AO standards contain
requirements that exceed those of CMS. The commenters believe that CMS
should only require Medicare CoP requirements on the Form CMS-2567
because any additional AO requirements that exceed Medicare CoPs are
proprietary standards. In addition, commenters believed it could be
confusing to the public if different requirements were listed for each
AO and reported on for hospices. Similar to the comment regarding AO
standards that exceed CMS requirements, a commenter also questioned
whether Form CMS-2567s would also include state licensure requirements.
Response: We explained in the proposed rule that changes to the
Form CMS-2567 would require OMB approval via notice and comment, and
that process would be separate from the rulemaking for this rule. 86 FR
35988. As noted above, CMS has recently updated the Form CMS-2567
pursuant to the process required by the PRA, including posting the
proposed changes for public comment. We made minimal changes to the
form, and we have no plans to update the form again to include any AO-
or State-specific requirements.
We note that including the Form CMS-2567 in AO reports of survey
findings is required by the statute and is one step towards providing
hospice patients and families information needed to make decisions on
where they wish to receive care, and we want that information to be as
clear and useful as possible. Since Medicare participation is partially
based on the findings of compliance surveys, which are used to
determine whether a hospice program meets the Medicare CoPs, we noted
in the proposed regulation, that AOs must include a statement of
deficiencies (that is, the Form CMS-2567 or a successor form) to
document survey findings for the hospice Medicare CoPs. Although AOs
are required to include the Form CMS-2567 in their reports to CMS, this
regulation does not require AO surveyors to use the form. For example,
while one AO may require its surveyors to use the Form CMS-2567 to
record survey findings, another AO may continue to allow its surveyors
to use its proprietary survey forms and then translate the survey
findings to Medicare CoPs on the Form CMS-2567.
Section 1865(a)(1) of the Act requires that for most provider
entities, including hospices, if the Secretary finds that the
requirements for accreditation from an AO demonstrate that a provider
entity meets or exceeds all applicable conditions, the Secretary must
deem such requirements to be met. The statutory language of ``meets or
exceeds'' currently allows AOs to develop additional standards that
differ from those of Medicare. When an AO applies for ``deeming
authority,'' we determine whether its standards meet or exceed ours.
With the required inclusion of the Form CMS-2567, we are not
restricting AOs from using accreditation standards that exceed the
Medicare CoPs. However, including the AO findings of the Medicare
hospice CoPs on the Form CMS-2567 allows CMS to post hospice program
survey reports from SAs and AOs in a manner that is standardized across
both types of surveying entities. We believe that including only CMS
requirements, and not state-specific licensure or AO-specific
requirements that vary across states and AOs, provides for consistency
and avoids confusion. AOs may still use additional standards that
exceed the Medicare CoPs, but documentation of whether hospice programs
meet those additional standards would not be on the Form CMS-2567.
Comment: A commenter expressed concern that incorporation of the
Form CMS-2567 into AO data systems could result in the duplication of
data.
Response: AO data systems are proprietary and therefore CMS is not
able to address specifics of how AOs will implement the Form CMS-2567
into in their systems. However, as part of the existing regulations at
Sec. 488.5(a)(4)(iv), AO survey reports must identify for each finding
of non-compliance with accreditation standards, the comparable Medicare
CoP, conditions for coverage, conditions for certification, or
requirements. Therefore, this data already exists in some form with
each AO survey report. Adding the requirement to include the Form CMS-
2567 (or a successor form) only changes the format and not the data
included. Additionally, we are not restricting the AO from reporting
survey findings in their existing AO format to their accredited
facilities. AOs would only need to extract the data related to the
Medicare CoPs into the Form CMS-2567 (or a successor form) for our
purposes. Ultimately, the information will align and be mirrored, but
not duplicative.
Comment: A commenter asked if there would be an opportunity for
hospice programs to preview the forms before they are submitted to CMS
to verify the accuracy of the reported information and to use
internally to act to correct the issues. Additionally, the commenter
asked what would happen if a deficiency is corrected during the survey
process.
Response: We thank the commenter for their clarifying questions and
note that this rule does not change the existing survey process
outlined in the State Operations Manual at Chapter 2 and Appendix M
related to completing the statement of deficiencies and submitting it
to the facility for review and response.
Comment: A few commenters requested that CMS clarify if AOs were
required to also have facilities use the form to submit their plan of
correction (POC) for identified non-compliance. They stated the Form
CMS-2567 formatting is antiquated and that AOs have electronic or
customer portal POC formats that guide the hospice to create a strong
POC, inclusive of all specific actions to be taken, date correction to
be completed, and individual responsible for correction process to
prevent recurrence with monitoring of corrective actions to ensure they
effectively prevent a recurrence. Commenters encouraged CMS to allow
AOs to continue the use of their electronic POCs and not require POC
[[Page 62365]]
documentation on the Form CMS-2567 itself.
Response: The Form CMS-2567 has a section for listing the
deficiencies and another section for providers to document their POC.
In 2017, CMS indicated that providers may document POCs in a separate
document instead of on the form itself. Stakeholders may refer to CMS
memorandum S&C:17-34-ALL which can be found at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-34.pdf.
Hospice programs have the flexibility to document their POCs in their
preferred format, including the format currently used by an AO. It is
important to note that all elements of an acceptable POC, as outlined
in the State Operations Manual, Chapter 2, Section 2728B, are still
required regardless of which format or document is used.
Comment: Most commenters expressed serious concerns about the
October 1, 2021, statutory deadline and urged CMS to provide enough
time for AOs to adapt their technology systems to include the use of
the Form CMS-2567. Specifically, AOs with hospice programs stated that
the proposed rule did not provide critical information on the process
and timing for submitting the Form CMS-2567 and therefore they do not
have the information necessary to build their data systems for
reporting purposes. AOs reported their need to analyze specifications,
design solutions, create new processes, and then perform testing on
their systems. Several commenters also noted the need to provide
training to familiarize surveyors and other staff with any new
processes and procedures that allow for completion and submission of
the Form CMS-2567 to CMS. The AOs and several commenters stated CMS
should either ask Congress for an extension of the October 1, 2021,
statutory deadline or delay at least 3 to 6 months for inclusion and
use of the form.
Response: We appreciate the concern and understands that it takes
time for AOs to adapt their systems to include the requisite form and
then submit it in a manner specified by CMS. We thank commenters for
their detailed feedback and note that CMS will develop associated
guidance to address many of the concerns raised by commenters regarding
the October 1, 2021, deadline, submission, and formatting/reporting. In
accordance with Sec. 488.8(b), CMS specifies in a written notice any
changes that affect accrediting organizations and provides a timeframe
to submit its proposed equivalent changes.
Final Decision: After consideration of the public comments we
received, we are finalizing the regulation at Sec. 488.5(a)(4)(x) as
proposed.
c. Release and Use of Accreditation Surveys (Sec. 488.7)
We proposed to add a new Sec. 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 its survey
information are related to an enforcement action taken by CMS against
the provider. However, CMS may post State agency complaints or
validation survey results of deemed hospice providers; CMS utilizes the
Quality, Oversight, and Certification Reports (QCOR) \102\ public
website for this purpose.
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\102\ Quality, Certification and Oversight Reports (QCOR)
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As mentioned in section VII.B.1.b of this final rule, CMS
recognizes there are challenges related to the system implications for
use of the Form CMS-2567 by the AOs. However, Congress removed the
prohibition that previously allowed AO hospice program survey reports
to be considered confidential and proprietary. We proposed 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 final 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 sought 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.
The 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 would require collaboration with industry stakeholders to
assure the development is fair and equitable across all hospice
programs.
Comment: Many commenters recommended that CMS establish a Technical
Expert Panel (TEP) that focuses on the display of survey findings,
which should include a wide array of stakeholders. Furthermore, they
believe this TEP should be responsible for identifying a comprehensive
algorithm to include salient Form CMS-2567 findings related to the
scope and severity of deficiencies and additional metrics that will
provide a more comprehensive overview of the hospice provider.
Response: The CAA 2021 mandates that survey findings be
``prominent, easily accessible, readily understandable, and searchable
for the general public and allows for timely updates.'' CMS recognizes
that a metric or algorithm would help to accomplish this goal, which
could integrate salient findings from the Form CMS-2567 that may be
utilized by the general public to adequately compare hospice providers'
services. CMS considers the publication of the Form CMS-2567 to be a
first step in meeting the intent of this provision. CMS remains
committed to continuing collaboration with hospice stakeholders after
this rule is finalized; we appreciate and are considering commenters'
suggestion to convene a TEP or other vehicle for gathering
stakeholders' input on ways to define a more comprehensive metric or
algorithm for public display in guidance.
Final Decision: After consideration of the public comments we
received, we are finalizing our proposal at Sec. 488.7(c) with one
technical change. We are modifying the regulatory text at Sec.
488.7(c) by changing ``accreditation organization'' to ``accrediting
organization'' for internal consistency within Sec. 488.7.
d. Providers or Suppliers, Other Than SNFs, NFs, HHAs, and Hospice
Programs With Deficiencies (Sec. 488.28)
Currently, the regulation at Sec. 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
[[Page 62366]]
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 survey agency's judgment 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 separately 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 condition-level 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 the SA or CMS. However, only CMS can impose an enforcement
remedy or termination or both. It 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 proposed revising the heading for
Sec. 488.28 to indicate that hospice programs would also be exempt
from the requirements set out in that section because we proposed POC
provisions for hospice programs with deficiencies in new subpart N, as
discussed in section VII.B.4 of this final rule.
Final Decision: We did not receive comments on this proposal and
therefore are finalizing this provision without modification.
3. New Subpart M--Survey and Certification of Hospice Programs
a. Basis and Scope (Sec. 488.1100)
We proposed at Sec. 488.1100 to specify the statutory authority
and general scope of the hospice program. As stated in the proposed
rule, this rule is generally based on the rulemaking authority in
section 1822 of the Act as well as specific statutory provisions
identified in the preamble where appropriate. We received no public
comments on this provision and we are finalizing it as proposed.
b. Definitions (Sec. 488.1105)
We proposed to add definitions at Sec. 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
Sec. 488.1.
Condition-level deficiency would mean noncompliance as
described in Sec. 488.24.
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
condition-level requirements, as determined by CMS or the State.
Comment: An AO commenter stated that they do not conduct what CMS
references as a standard level survey, but all initial and renewal
reviews are comprehensive surveys.
Response: We acknowledge that the terminology of ``standard
survey'' may vary with AOs and that the AOs are still required under
Section 1865 of the Act to meet or exceed Medicare requirements and
survey procedures. We also note that the new requirement at Sec.
488.1110(a) requires a hospice standard survey (initial,
recertification, or renewal) to be conducted not later than 36 months
after the date of the previous standard survey. While the regulation at
Sec. 488.5(a)(4)(i) provides a timeframe for AOs of 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, we expect hospice AOs to follow the new requirement for hospice
surveys at Sec. 488.1110(a) to be comparable with the requirements
outlined for SAs. Therefore, the new hospice requirement at Sec.
488.1110(a) would supersede the AO requirement at Sec. 488.5(a)(4)(i)
for hospice surveys.
After consideration of the public comments we received, we are
finalizing this section as proposed.
c. Hospice Program Surveys and Hospice Program Hotline (Sec. 488.1110)
At proposed Sec. 488.1110(a), a standard survey would have to be
conducted not 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 Sec. 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 Sec. 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
[[Page 62367]]
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 proposed 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 Sec. 488.1110(b)(2) we proposed 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 would
be described in the annual CMS Quality, Safety and Oversight Group's
Mission and Priority Document (MPD) that serves as the scope of work to
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 sought public comment on current experiences with the
HHA toll-free hotline as required by section 1864(a) of the Act. We
sought this information to inform CMS of potential 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.
Comment: Several commenters were in support of the CAA 2021, which
makes permanent the requirement that hospice programs receive
recertification surveys no less frequently than once every 36 months. A
commenter recommended that CMS clarify the implementation dates related
to the hospice surveys.
Response: The Improving Medicare Post-Acute Care Transformation Act
of 2014 (IMPACT Act) (Pub. L. 114-185) initially amended section
1861(dd)(4) of the Act to provide that hospice programs will be subject
to a standard survey every 36 months beginning six months from
enactment through September 2025. The CAA 2021 amends Title XVIII of
the Act to permanently continue this provision. CMS is codifying this
mandate into regulation. Hospice programs will continue to be surveyed
not later than 36 months after the date of the previous survey.
Comment: A commenter stated that CMS should establish a 6-month
timeframe in which surveyors must conduct complaint surveys once an
allegation is reported.
Response: We currently maintain a national complaint tracking and
prioritization system which prioritizes complaints according to the
level of risk for a hospice program's patients. Complaints that
indicate the possibility of an immediate jeopardy situation are given
the highest priority and investigated by the State as soon as possible.
The State Operations Manual, chapter 5, specifies the timeframes and
procedures by which all types of complaints should be investigated.
Comment: A commenter stated serious concerns about the ability of
SAs and AOs to increase staffing to support more frequent surveys. The
commenter states that the Department of Health and Human Services and
the Office of the Inspector General (OIG) have documented a substantial
backlog of standard surveys, with roughly 71 percent of nursing homes
that have gone at least 16 months without a standard survey as of May
31, 2021.
Response: The requirement to survey hospice programs every three
years was initially established in the Improving Medicare Post-Acute
Care Transformation Act of 2014 (IMPACT Act) and the CAA 2021
establishes permanency of the continuation of this requirement. We are
codifying this mandate into regulation. The AOs are currently required
in regulations to survey hospice programs every three years, which is
the same as the legislative requirement. Hospice programs will continue
to be surveyed not later than 36 months after the date of the previous
survey by the SA or AO.
The comment regarding the substantial backlog of nursing home
surveys referenced is outside the scope of this rule.
Comment: Several commenters support codifying and making uniform
throughout the United States a dedicated toll-free hospice hotlines,
each maintained by the appropriate State or local agency. The
commenters supported the proposed use of hotlines to collect, maintain,
and continually update information, as well as to receive complaints,
on hospice programs located in the State or locality that are certified
to participate in the Medicare program. Commenters noted that the State
or local agency must also maintain a unit for investigating such
complaints and that many State or local agencies have existing hotlines
for home health agencies.
Response: We appreciate the support. State or local agencies that
have existing toll-free hotlines for home health agency complaints can
utilize this hotline to also collect and maintain information on
hospice programs. However, the State or local agency may decide to
establish a separate toll-free hotline specific to hospice programs.
Comment: A commenter recommends that the State or local agency
staff the hospice hotline with individuals who are appropriately
trained on hospice care and the hospice philosophy.
Response: We believe that the hospice hotline staff decision should
be left to the State or local agency. The State or local agency follows
the MPD that discusses survey and certification functions as well as
the Medicare funding allocation process for states, which directly
impacts the work prioritization and planning for the required survey
workload in the fiscal year the MPD is issued.
Final Decision: After consideration of the public comments we
received, we are finalizing this section as proposed.
d. Surveyor Qualifications and Prohibition of Conflicts of Interest
(Sec. 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 Sec. 488.5(a)(8) to provide
training to their surveyors. As the AO requirements outlined in Sec.
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 Sec. 488.1115, we proposed that all SA and AO hospice program
surveyors would be required to take CMS-provided surveyor basic
training currently available, and additional training as specified by
CMS. As part of the AO application and reapplication process under
Sec. 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 Sec. 488.1115, AO
surveyors
[[Page 62368]]
would be required to complete the online CMS hospice program basic
training. CMS proposed that until the rule is finalized, that it
accepts 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
the 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
Sec. 418.52 Condition of Participation: Patient's rights; Sec. 418.54
Condition of Participation: Initial and comprehensive assessment of the
patient; Sec. 418.56 Condition of Participation: Interdisciplinary
group, care planning and coordination of care; and, Sec. 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 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 sought 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 proposed 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 proposed to include
hospice AO surveyors under this requirement as well.
In 2012, as part of an effort to mitigate conflicts of interest in
the HHA survey process, CMS established requirements at Sec.
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.'' \103\
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\103\ CMS State Operations Manual, Chapter 4 Medicare State
Operations Manual (cms.gov) (Internet Only Manual, Pub. 100-07).
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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, an 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 proposed
to codify these long-standing policies for both SA and AO surveyors to
ensure there is no conflict of interest between the organization and
the surveyor.
We proposed 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 would utilize the definition of ``immediate
family member'' located at Sec. 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-in-law, daughter-in-law, brother-in-law, or
sister-in-law; grandparent or grandchild;
[[Page 62369]]
and spouse of a grandparent or grandchild.
(1) Surveyor Qualifications
Comment: While commenters notably agreed that requiring all
surveyors (AOs, State, and CMS Location surveyors) to take the training
offered by CMS provides greater consistency, several expressed concern
that the timeline would have the effect of needing to pull surveyors
without training from the field by October 1, 2021, contributing to
further backlogs in surveys, already large due to COVID restrictions.
They requested that CMS allow a period beyond October 1, 2021, the
current date for implementation of this provision.
Response: We anticipate that the revised Hospice Basic Training
will be available at the time of the implementation of this rule.
Surveyors should take the training that is available when their
individual need for training arises (that is, upon hiring, or if
beginning to survey a provider they have not previously been trained to
survey). CMS will post a training update of changes in the new version
for surveyors who used the older version of the CMS training so that
they will not have to take the new training in its entirety.
Comment: Commenters made several suggestions related to surveyor
training. Additional training content areas were suggested such as
addressing psychosocial, emotional, and spiritual components of hospice
care, that surveyors be trained to cite based on evidence of trends
rather than a single violation, and requiring a minimum number of
surveys as well as ongoing eligibility via competency evaluation and
continuing education.
Response: These comments are outside of the scope of this rule,
which focuses on the universality of CMS training. We note that the
training suggestions are already included in CMS' hospice training (for
example. citing deficiencies based on severity and frequency, and not
just a single occurrence, unless it is severe) and among the
experiential requirements for surveyors (minimum number of monitored/
supported surveys prior to surveying independently). Regarding ongoing
training and competency, we rely on the managerial oversight of state
agencies, with the assistance of state training coordinators to monitor
surveyor abilities, and direct access to the many additional training
opportunities available through the CMS Quality, Safety & Education
Portal (QSEP-https://qsep.cms.gov/).
Comment: Some commenters suggested that surveyors should have
``real-world experience'' or have worked in hospice care to qualify to
be hospice surveyors.
Response: We are confident that given the appropriate professional
background as a licensed physician, RN, social worker, or chaplain,
surveyors' professional training, along with CMS training, that
surveyors are fully prepared to conduct accurate field assessments of
compliance with the Medicare Conditions of Participation (CoPs).
Additionally, surveys are reviewed at multiple levels--through
validation surveys and managerial oversight--to corroborate the
interpretation of findings and citing of deficiencies.
Comment: A commenter stated that we should include emergency
preparedness (EP) in hospice training as well as address patient safety
in the comprehensive assessment.
Response: Though not expressly addressed in the comprehensive
assessment, safety is addressed throughout the CoPs. EP is addressed in
hospice training and references the dedicated State Operations Manual
appendix and training related to EP.
Final Decision: After consideration of the public comments we
received, we are finalizing the surveyor qualification provisions as
proposed.
(2) Prohibition of Conflicts of Interest
Comment: A few commenters expressed appreciation of CMS' proposals
to implement conflict of interest provisions as they believe it is an
important element of ensuring fairness in the survey process.
Response: We appreciate the support for our prohibition of
conflicts of interest proposals.
Comment: A commenter suggested that CMS develop a code of ethics
for surveyors instead of trying to list out every potential conflict of
interest. Additionally, it was suggested the code of ethics be tied to
online training where surveyors would take the training and then sign
the code of ethics.
Response: We appreciate the suggestion. Addressing conflicts of
interest can be challenging because it is not possible to list all
situations which could be construed as potential conflicts. CMS takes
the responsibility of public trust very seriously and as such has a
long-standing policy in the State Operations Manual, Chapter 4, which
outlines the process for abuses of influence, privileged information,
or trust arising through conflicts of interest. We believe these
provisions address the most common scenarios where conflicts arise
nationally. While we believe a code of ethics for surveyors is
valuable, we will consider this suggestion for future policy changes
that would affect all surveyors and all programs as this is out of
scope for the current hospice program rule. We also appreciate the idea
of adding it to a CMS training course and will consider this in the
future.
Comment: A commenter suggested that CMS consider requiring
surveyors to professionally attest that they are aware and will comply
with the prohibition on conflicts of interest. Furthermore, they
expressed support for a provision requiring surveyors to attest that
they intend to judge providers objectively, within the bounds of the
CoPs, and refrain from relying on any personal convictions about what
end-of-life care should be or ought to entail.
Response: Similar to the suggestion for CMS to consider developing
a code of ethics for surveyors, we appreciate the idea of attestation
and will consider this in future policy changes for surveyors of all
programs.
Comment: A few commenters stated CMS should develop materials to
help guide surveyors and survey entities regarding potential conflicts
of interest.
Response: We agree that surveyors benefit from training materials
related to conflicts of interest. Currently, CMS has training in the
Quality Safety and Education Portal (QSEP) related to surveying for
non-long term care (non-LTC) that aids learners in developing surveyor
skills and proficiency by establishing a foundational understanding of
the non-LTC survey process. This training addresses roles and
responsibilities of surveyors, including conflicts of interest. CMS
will review the existing training and will make updates as needed.
Comment: Multiple commenters suggested additional conflicts of
interest for consideration including: Prohibiting anyone who has a
family member using hospice services; surveyors with prior work
history, including termination from, a hospice being surveyed; or work
history with a hospice's competitor. Specifically, commenters expressed
concern with conflicts of interest arising out of a work history that
includes an employment arrangement with a hospice's competitor and a
suggestion was made that CMS consider a 2-year ban on staff from
competing hospices surveying each other. However, a few commenters
acknowledged addressing such a conflict through regulation may be
challenging as it would be difficult to determine how far such a
prohibition could extend. Several commenters also noted that adding
additional conflicts
[[Page 62370]]
could create challenges in small, rural communities but encouraged CMS
to provide surveyors with the opportunity to recuse themselves if
needed.
Response: We appreciate the additional considerations and concerns
that commenters have raised. We are particularly interested in the
comments raised regarding competition between hospices and the
potential conflict of interest if surveyors work for one hospice and
participate in survey activity of known competitors. CMS has considered
this potential conflict of interest and agrees with commenters that it
would be challenging to address through rulemaking as it could be said
that all hospices in certain geographic locations are considered
competitors. We also agree with the concerns raised regarding small,
rural communities and limiting surveyor availability. CMS, SAs, and AOs
are all responsible for evaluating the need for preventive measures to
protect the integrity of the survey process. All relevant circumstances
that may exist beyond the benchmarks given in regulations should be
considered to ensure that the integrity of the survey process is
preserved. As noted in the current CMS State Operations Manual policy,
SA administrators should require employees to make a declaration of any
such outside interests and update this declaration periodically.
Therefore, we believe surveyors are responsible for disclosing and
recusing themselves as needed.
Final Decision: After consideration of these comments, we are
revising Sec. 488.1115 to add a requirement that surveyors must
disclose actual or perceived conflicts of interest prior to
participating in a hospice program survey and be provided the
opportunity to recuse themselves as necessary.
e. Survey Teams (Sec. 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 proposed at Sec.
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--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 1 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, we seek to better understand the current
professional makeup of survey entities' workforces. In order to track
compliance with this provision, we proposed 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 an RN; (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 Sec. 418.56 require that hospice programs use
interdisciplinary teams or groups to determine a holistic plan of care
for the hospice program patient and family. The interdisciplinary group
or IDG, must include, but not be limited to a physician, an RN, a
medical social worker, and pastoral or other counselor. Therefore, we
proposed that when the survey team comprises more than one surveyor,
the additional slots would be filled by professionals from among these
disciplines, and we sought comments on this approach. Similarly,
section 1819(g)(2)(E) of the Act and 42 CFR 488.314 require that long-
term care (LTC) 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 LTC 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.
Comment: Several commenters provided feedback on the makeup of
survey teams, in response to the proposed provision that survey teams
should be multi-disciplinary. Commenters suggested that a licensed
practical nurse should be included on the survey team.
Response: We proposed that the survey teams be multidisciplinary
and that at least one member of the survey team must be an RN. These
are statutory requirements, and they are consistent with the current
guidance in the SOM, Appendix M. Because an RN will be on every survey
team, to ensure that the survey team is multidisciplinary, if there is
more than one surveyor, then the additional team members must be
selected from other disciplines included in the interdisciplinary
group.
Comment: Several commenters suggested that the survey team members
be required to have prior experience in the hospice field.
Response: We do not require that surveyors have actual hospice
experience, nor target particular types of hospice expertise (that is,
former hospice administrators). It is at the discretion of the hiring
state survey agencies to identify individuals whose background is
suitable. All surveyors must successfully complete CMS-based training
to ensure that they are capable of conducting accurate and complete
surveys. CMS's training includes substantial detail in content and
interactive learning in the hospice philosophy of care and all hospice
regulatory requirements, as well as guidance in survey technique and
procedures specific to the CoPs. With the appropriate professional
background (that is, credentialing in one of the disciplines included
in the IDG) and CMS's hospice-specific training, we believe surveyors
will have the expertise needed to conduct surveys for compliance with
Medicare's well-prescribed requirements.
Final Decision: After consideration of the public comments we
received, the proposed policy is being finalized without modification.
[[Page 62371]]
f. Consistency of Survey Results (Sec. 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 proposed at
Sec. 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, in the proposed rule we noted that we expected to
promulgate objective measures of survey accuracy, and sought public
opinion on what measures would be feasible for States. We desired
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
were found, CMS would be 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-to-the-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
proposed 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 condition-level 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 proposed for
hospice programs 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 . . . 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 . . .'' 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 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, we
proposed 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.
Comment: Commenters supported our plans to create more
opportunities for consistency between survey entities as well as
between surveyors within the same surveying entity. They noted CMS'
plan to require universal use of CMS hospice training as a key element
of this effort. A commenter suggested that in this effort, CMS should
provide AO surveyors with access to QSEP at the same level as state
surveyors, so that all content and not just Basic Training is available
to the AO surveyors as a means of greater consistency across agencies.
[[Page 62372]]
Response: We will modify access to QSEP for AO surveyors on the
same basis as for state surveyors, so that all appropriate content is
available, though only Hospice Basic will be required by the AO
surveyors.
Final Decision: After consideration of the public comments we
received, the proposed policy is being finalized without modification.
g. Special Focus Program (SFP) (Sec. 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 proposed at Sec. 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 proposed 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 LTC facilities and outlined the following protocol for a
hospice SFP in the proposed rule:
The SA and CMS SOG location would receive a list from CMS
of all hospice programs that meet the established criteria at proposed
Sec. 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 sought public comment regarding the SFP, specifically the
following issues:
Should CMS utilize a similar criteria, process, or
framework for the SFP as outlined in the current Special Focus Facility
Program used for LTC facilities? What if any differences should CMS
consider to enhance the overall impact of the hospice SFP?
Are there 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.
Should we utilize a Technical Expert Panel (TEP) to
enhance the SFP in terms of selection, enforcement and technical
assistance criteria while a hospice is in the program? A TEP may assist
CMS by identifying contextual data and relevant information that would
help 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.
Comment: Many commenters believe that CMS should not implement this
provision until a comprehensive framework can be established that
focuses on a targeted approach in the identification and enrollment of
hospice programs to the SFP. Some commenters stated that the criteria
outlined in the proposed rule are subjective and may lead to
inconsistencies across State Agencies in hospice identification and
enrollment in the SFP, without addressing the most non-compliant
hospices for not delivering quality care and putting patients at risk.
Given the complexities associated with this proposal, commenters agreed
that CMS should use a TEP that includes a wide array of stakeholders to
assist CMS in the development of a comprehensive algorithm that would
include relevant findings from the Form CMS-2567 and other metrics
related to hospice performance. Commenters also thought that CMS should
include relevant tools and education to assist hospice providers that
participate in the SFP to improve quality and compliance prior to
termination.
Response: The CAA 2021 mandates that a SFP be established to
identify poor-performing hospice programs and enhance the quality of
care. CMS recognizes that to accomplish the intent of this provision
elements, in addition to the Form CMS-2567, may be needed to develop a
comprehensive structure and methodology for a targeted approach to
identify, select, and remove a hospice program for inclusion in the
SFP. Given the intent of this provision to identify the poorest
performing hospice programs and the need to define a comprehensive
structure and methodology for selection into the SFP, CMS intends to
review the public comments received and collaborate with hospice
stakeholders to further develop the SFP that was initially proposed.
Taking into account the comments that we have received on this
proposal, we are not finalizing the proposed SFP requirements at
proposed Sec. 488.1130. We intend to work on a revised proposal and
will seek additional collaboration with stakeholders to further develop
the structure and methodology for implementing the SFP, which we hope
to include in a proposal for FY 2024 rulemaking.
4. New Subpart N--Enforcement Remedies for Hospice Programs With
Deficiencies
a. Statutory Basis (Sec. 488.1200)
We proposed to set out the statutory basis for the proposed new
subpart at Sec. 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 Sec. 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 Sec. 489.53(a)(3), CMS may
terminate a hospice program provider agreement if that hospice program
is not in substantial
[[Page 62373]]
compliance with the Medicare requirements (that is, the failure to meet
one or more CoPs is considered to be a lack of substantial compliance).
We did not receive comments on this proposal and therefore are
finalizing this provision without modification.
b. Definitions (Sec. 488.1205)
We proposed to add Sec. 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 proposed 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.
We did not receive comments on this proposal and therefore are
finalizing this provision without modification.
c. General Provisions (Sec. 488.1210)
We proposed at Sec. 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. We proposed that our decision to impose one or more
remedies, including termination, would 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 each discrete condition-level deficiency constituting
noncompliance.
As noted in the proposed rule, 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 Sec. 488.1210(e), we proposed that 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 would be corrected. CMS would determine if the
POC was acceptable based on the information presented.
At proposed Sec. 488.1210(e), we proposed the notification
requirements for enforcement remedies for hospice programs that will be
issued by CMS. CMS would 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 proposed a CMP and the amount being imposed
(if applicable), the proposed effective date of the sanction, and
appeal rights.
We proposed 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
proposed to codify these proposals at Sec. Sec. 488.1225(b) and
488.1230(b), respectively.
With respect to CMPs, we proposed 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 proposed to codify these proposals
at Sec. 488.1245(e).
We proposed 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 Sec. 488.1245(f).
Comment: Several commenters recommended the incorporation of the
informal dispute resolution (IDR) process to also align with the
process available for HHAs.
Response: We thank the commenters for their suggestion about
incorporating an informal dispute resolution (IDR) process, but because
the IDR process was not proposed in this rule, we are not including it
at this time. We will consider the commenter's suggestions for future
rulemaking.
Final Decision: After consideration of the public comments
received, we are finalizing this provision with one modification based
on changes to proposed Sec. 488.1240, which are discussed in section
VII.B.4.i of this final rule. Because payment suspensions will apply
only to new patient admissions, there will be no ambiguity as to which
payments are being suspended. Accordingly, we are removing the
requirement at Sec. 488.1210(e) that the notice to hospice providers
identify which payments are being suspended.
d. Factors To Be Considered in Selecting Remedies (Sec. 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 the proposed rule, we proposed to establish
requirements for enforcement remedies that may be
[[Page 62374]]
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 Sec. 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 immediate jeopardy (IJ) situation. We proposed at Sec.
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, we proposed 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.
Comment: Several commenters requested that CMS provide staff in the
CMS locations (formerly CMS Regional Offices) training in the factors
to be used in making determinations on when remedies should be applied
and develop processes to ensure these remedies are consistently
applied. A commenter stated that this guidance and training should also
be made available to hospice providers.
Response: We will develop associated guidance and provide training
to CMS location and SA staff, as appropriate, that will address the
concerns raised by the commenters regarding the procedures that will be
followed to apply and implement the enforcement remedies while also
allowing for surveyor judgment. Developed guidance and training will be
made publicly available.
Comment: A few commenters recommended a step-wise approach to
enforcement remedies for hospice programs that consider the seriousness
and prevalence of the deficiency beginning with more targeted education
remedies (for example, directed plan of correction and directed in-
service training) to more stringent remedies for more severe
deficiencies.
Response: We have set forth the factors upon which we will base our
choice of remedy or remedies. Those factors include the extent to which
the deficiencies are directly related to a failure to provide quality
care and pose an immediate threat to patient health and safety, as well
as the nature, incidence, manner, degree, and duration of the
deficiencies or noncompliance.
Final Decision: After consideration of the public comments we
received, we are finalizing this section as proposed.
e. Available Remedies (Sec. 488.1220)
Section 1822(c)(5)(A)(ii) of the Act provides that we ``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 1861(dd) of the Act; (2) suspension of all or part of payments,
, 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 proposed to add a directed POC and directed in-service training as
additional enforcement remedies at Sec. 488.1220.
We did not receive comments on this proposal and therefore are
finalizing this provision without modification.
f. Action When Deficiencies Pose Immediate Jeopardy (Sec. 488.1225)
and Termination (Sec. 489.53)
For situations involving IJ, if we determine 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 proposed at Sec. 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, we will
terminate the hospice program's provider agreement. In addition, we
could impose one or more enforcement remedies including a CMP,
temporary management, and/or suspension of Medicare payments before the
effective date of termination.
We proposed Sec. 488.1225(b), that for a deficiency or
deficiencies that pose IJ, we would provide the hospice program with at
least 2 days advance notice of any proposed remedies, except CMPs
(discussed at proposed Sec. 488.1245). The requirements for a notice
of intent are set forth at proposed Sec. 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 we 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, we proposed that we would 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
proposed to amend Sec. 489.53(a)(17) to indicate that we would
terminate a hospice program's (as well as an HHA's) provider agreement
if
[[Page 62375]]
the hospice program failed to correct a deficiency or deficiencies
within the required time frame.
Finally, at proposed Sec. 488.1225(c), we proposed 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.
Comment: Several commenters recommended that CMS clarify the notice
period in calendar days for action imposed when deficiencies pose
immediate jeopardy or are at the condition-level but do not pose
immediate jeopardy.
Response: We appreciate the comments and in this final rule added
``calendar'' days for the notice period in the titles at Sec. Sec.
488.1225(b) and 488.1230(b). Additionally, we are making a technical
correction in Sec. 488.1225(b) to reflect the notice requirements are
outlined in Sec. 488.1210(e), not Sec. 488.1225(e).
Comment: Several commenters recommended that CMS consider the
method that will be used to deliver the notices and whether 2 days is
reasonable. Commenters stated situations where the statement of
deficiencies has exceeded the 10-business day delivery requirement to
the provider and they are concerned that delays will occur when
enforcement remedies are applied. Commenters recommended that for
delays in the statement of deficiencies that the hospice provider
should be granted an extension for the plan of correction submission
equivalent to the number of delinquent days, and commenters also
believed that in situations where enforcement remedies are applied, the
implementation date of the remedy should be delayed for the same number
of days that the notice is delinquent. One commenter recommended that
CMS investigate the reasons for these delays and implement processes to
remedy the situation.
Response: The 2-day calendar notice is to inform the hospice
program of the immediate jeopardy situation and that the hospice
program will be terminated in 23 days unless the immediate jeopardy is
corrected and for all imposed remedies, except for CMPs. This policy is
consistent with the current HHA requirements and has been used in
immediate jeopardy situations for other providers. The written notice
will be delivered in hard copy by mail or in an electronic format, such
as email. The 2-day calendar notice of termination with an immediate
jeopardy finding is prudent considering the short 23-day time frame to
attain compliance and also given the serious risk to patient health and
safety. For remedies imposed when there is immediate jeopardy, the
notice will be given at least 2 calendar days before the effective date
of the enforcement action. The notice will include the requirements
finalized in Sec. 488.1210(e) that includes the proposed effective
date of the remedy. The recommendation for us to investigate delays in
notices and implement processes to remedy the situation is beyond the
scope of this rule.
Final Decision: After consideration of the public comments we
received, we are adding the word ``calendar'' to the 2-day notice at
Sec. 488.1225(b) and fixing a technical error in that same paragraph,
in the reference to notice requirements, to accurately reflect Sec.
488.1210(e).
g. Action When Deficiencies Are at the Condition-Level But Do Not Pose
Immediate Jeopardy (Sec. 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 the 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 the proposed rule, we specified that enforcement remedies, such
as those proposed in Sec. 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 would end
when the hospice program corrects all condition-level deficiencies or
is terminated from the Medicare program.
We proposed at Sec. 488.1230, that for a deficiency or
deficiencies that do not pose IJ, we would provide the hospice program
at least 15 days advance notice of any proposed remedies, except for
CMPs (discussed at proposed Sec. 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 Sec. 489.53(d)(1).
Comment: Several commenters recommended that for enforcement
remedies at the condition level that do not pose immediate jeopardy,
CMS clarify that the notice period is in calendar days.
Response: We appreciate the comments and in this final rule we have
included ``calendar'' in the title at Sec. 488.1230(b).
Final Decision: After consideration of the public comments we
received, we are adding the word ``calendar'' to the 15-day notice at
Sec. 488.1230(b).
h. Temporary Management (Sec. 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 proposed at Sec.
488.1205, ``temporary management'' means the temporary appointment by
us or an 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 Sec. Sec.
418.100 and 418.114 and would be under the direction of the hospice
program's governing body.
We proposed at Sec. 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
proposed to specify the duration and effect of this
[[Page 62376]]
enforcement remedy, and the payment procedures for temporary managers'
salaries and other additional costs. We would provide the hospice
program with written notice of our intent to impose a temporary
management remedy in accordance with proposed Sec. 488.1210(e).
At Sec. 488.1235(a), we proposed that temporary management would
be imposed when a hospice program is determined to have condition-level
deficiencies and that the deficiencies or 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
proposed at Sec. 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 proposed at Sec. 488.1235(b) if the hospice program refuses to
relinquish authority and control to the temporary manager, we would
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
proposed at Sec. 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 would not exceed a period of 6 months
from the date of the survey identifying noncompliance.
At Sec. 488.1235, we proposed 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 proposed 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. We 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.
Comment: Several commenters stated that when the temporary
management enforcement remedy is imposed, the individual acting as the
temporary manager should complete the basic CMS hospice surveyor
training before beginning their assignment.
Response: Although not an explicit requirement, we encourage the
temporary manager to complete the basic CMS hospice surveyor training.
The training is available free of charge on the QSEP website at https://qsep.cms.gov, to providers and all entities conducting surveys, and
the public at large. QSEP training is accessible on an individual,
self-paced basis. The basic training courses provide surveyors with the
key knowledge and skills needed to survey the respective provider or
supplier type for compliance with the Medicare CoPs and assure an
adequately trained, effective surveyor workforce.
Comment: Several commenters recommended that we clarify whether a
temporary manager is required to be external to the hospice
organization.
Response: The temporary manager must have the experience and
education that qualifies the individual to oversee the hospice program.
The temporary manager can be either internal or external to the hospice
program, and will be appointed by CMS or the SA based on qualifications
described in Sec. Sec. 418.100 and 418.114. Additionally, the
temporary manager would be under the direction of the hospice program's
governing body.
Final Decision: After consideration of the public comments we
received, we are finalizing this section as proposed.
i. Suspension of Payment for All New Patient Admissions (Sec.
488.1240)
We proposed in Sec. 488.1240 provisions describing when and how we
would apply a suspension of payment for all new patient admissions on
or after the date on which the Secretary determines that remedies
should be imposed under Sec. 488.1225 or Sec. 488.1230. We proposed
that 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. We proposed to determine whether to impose a suspension of all
or part of the payments on or after the effective date of the
enforcement remedy. We proposed to determine whether to impose a
suspension of payment based on the factors outlined in proposed Sec.
488.1215 that are considered when selecting remedies. The suspension of
payment was proposed at Sec. 488.1240 to be for a period not to exceed
6 months and would end when the hospice program either achieved
substantial compliance or was terminated. We proposed to 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 Sec. 488.1225(b), or 15
calendar days before the effective date of the remedy in non-IJ
situations, per proposed Sec. 488.1230(b). The proposed notice of
intent for all remedies, described at Sec. 488.1210(e), would be used
to notify a hospice program of a suspension 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 we find 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 would end when the
hospice program is determined to have corrected all condition-level
deficiencies, or upon termination, whichever is earlier. We proposed to
codify that duration of the remedy at Sec. 488.1240(c).
[[Page 62377]]
Comment: Several commenters expressed concerns and requested that
CMS consider limiting the suspension of all or part of payments to new
hospice admissions only. The commenters stated that a suspension of
payment not limited to new hospice admissions would result in a
disproportionate financial burden on hospice providers and would affect
access to care. Commenters also stated that limiting the suspension of
all or part of payments to new hospice admissions only would be
consistent with existing HHA enforcement sanctions, Congressional
intent, and OIG recommendations. A commenter recommended we consider
suspension of all or part of payments to new hospice admissions only in
the case of an immediate jeopardy situation.
Response: We have considered the commenters' suggestions and agree
that limiting the payment suspension to all new patient admissions
would help avoid disproportionate financial burdens on hospice
programs. In addition, for poor performing hospice programs, CMS
continues to have the option to terminate.
Final Decision: After consideration of the public comments we
received, we are finalizing this provision with modifications to limit
the suspension of payments to all new patient admissions. As noted
elsewhere, we have made conforming edits to Sec. Sec. 488.1210(e),
488.1220(b), and 488.1260(a)(1)(i).
j. CMPs (Sec. 488.1245)
We proposed at Sec. 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. We
proposed 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. We 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 Sec. 488.845, which we 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 proposed both ``per day'' and ``per instance''
CMPs at Sec. 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 proposed to impose a CMP for that instance or those
individual instances of noncompliance. We proposed to define ``per
instance'' in Sec. 488.1205 as a single event of noncompliance
identified and corrected during a survey, for which the statute
authorizes that we 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 proposed penalties from $1,000 to
$10,000 per instance. Such penalties would be 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 proposed that, in addition to those factors that we would
consider when choosing a type of remedy proposed in Sec. 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 Sec. 488.1245, we 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 proposed at Sec. 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
proposed to establish a three-tier system with subcategories that would
establish the amount of a CMP.
In proposed Sec. 488.1245(b)(3), (4), and (5), we proposed 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 we imposed a CMP, we 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 Sec. Sec. 488.1210(e)
and 488.1245(c). Once the administrative determination is final, we
proposed 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
[[Page 62378]]
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 Sec.
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 Sec. 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 Sec. 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 proposed at Sec.
488.1245(d) that in IJ cases, if the IJ is not removed, the CMP would
continue to accrue until we terminated the provider agreement (within
23 calendar days after the last day of the survey which first
identified the IJ). Under proposed Sec. 488.1245(d)(4), if IJ did not
exist, the CMP would continue to accrue until the hospice program
achieved substantial compliance or until we 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 Sec. 488.1245(e).
We also proposed 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 Sec. 488.1245(e), would
be included in the termination notice.
At proposed Sec. 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;
We 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 us.
Comment: Commenters recommended CMS develop specifications for
penalties collected at the national and/or state level for hospice
program improvements.
Response: Determinations on whether to impose an enforcement remedy
and the specific remedy to be imposed will not be left to the sole
discretion of the hospice surveyor. All final decisions regarding
whether or not to impose a remedy and what type of remedy to be imposed
will be made by the applicable CMS Location. Any funds collected as a
result of CMPs imposed upon a hospice are distributed to the State
Medicaid Agency and to the US Treasury under section 1128A(f) of the
Act. Additionally, the CAA 2021 included a provision at section
1822(c)(5)(C) that allows the Secretary to use a portion of the CMPs
collected to support activities that benefit individuals receiving
hospice care, including education and training programs to ensure
hospice program compliance. We will consider using this authority to
support improvement activities in hospices in the future and will
consider developing interpretive guidance for clarification as needed.
Comment: Many commenters recommended that CMS consider a hospice
provider-initiated improvement plan to achieve positive outcomes and
sustained compliance over a ``look back'' period in determining whether
to impose the CMP remedy for previous noncompliance.
Response: We disagree that a hospice provider-initiated improvement
plan should be a determination on whether to impose the CMP remedy for
previous noncompliance. The hospice program is expected to be in
continuous compliance with the health and safety CoPs. When we
determine the amount of the CMP penalty, one factor that is considered
is evidence that the hospice program has an internal quality assessment
and performance improvement system to ensure patient health and safety
and compliance with the CoPs. We are finalizing as proposed the
requirement at Sec. 488.1245(b)(1)(iii) that CMS take into account
that the hospice program has evidence of a self-regulating quality
assessment and improvement plan when determining the amount of the
penalty. We can also decrease the CMP penalty amount from the upper
range to the middle or lower range if a condition-level deficiency
exists and the hospice program shows an earnest effort to correct
systemic causes of the deficiencies and sustain improvement. We are
finalizing as proposed the requirement at Sec. 488.1245(b)(7) to allow
CMS to shift the CMP amount imposed per day from the upper range to the
middle or lower range.
Comment: Commenters recommended that CMS use a scaled approach to
CMPs based on deficiency scope and severity and a commenter noted that
CMS proposes criteria that also include factors that account for the
size of the hospice program and its resources in order to provide some
relief for small hospice programs.
Response: We will factor in the size of the hospice program and its
resources when considering the amount of the CMP as proposed in Sec.
488.1245(b)(1)(ii). CMPs may be adjusted based on revisit survey
findings and after a review of the provider's attempted correction of
deficiencies as proposed in Sec. 488.1245(b)(2). Additionally, 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 as proposed in Sec. 488.1245(b)(8)(iii).
Comment: Commenters encouraged CMS to provide a standardized,
transparent process regarding the calculation of CMPs.
Response: The proposed CMP regulations at Sec. 488.1245 provide a
transparent process regarding CMP application, penalty amounts and
adjustments, and appeal procedures consistent with requirements
standardized for HHAs. CMS will also consider developing interpretive
guidance for clarification as needed.
Final Decision: After consideration of the public comments we
received, we are finalizing this section as proposed.
[[Page 62379]]
k. Directed Plan of Correction (Sec. 488.1250)
We proposed at Sec. 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 the correction of deficient practices.
Specifically, we proposed that we 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 Sec. 488.1250(b)(2) a hospice
program's directed POC would be developed by us 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,
we 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, we would provide appropriate
notice to the hospice program under Sec. 488.1210(e).
Comment: Commenters were in support of the proposed directed POC
and directed in-service training enforcement remedies that align with
the available home health alternative sanctions. A commenter
recommended that the directed POC be developed by CMS or by the
temporary manager, with CMS approval. The commenter also recommended
that the directed POC include follow-up reports to CMS or the SA and/or
a resurvey to ensure continued progress and compliance with the
directed POC. Additionally, the commenter recommended that directed
POCs ultimately be publicly reported and delineate between and among
deficiencies, especially regarding the scope and severity of such
deficiencies.
Response: We appreciate the support for the proposed directed POC
and directed in-service training enforcement remedies that align with
the available home health alternative sanctions. Similar to HHAs, a
directed POC can be guided by CMS, the SA, or a temporary manager (with
CMS/SA approval) to ensure that the underlying cause of the cited
deficiency or deficiencies does not recur. Follow-up reports to the
directed POC and/or a resurvey to ensure compliance with the directed
POC will be at the discretion of CMS or the SA. The public reporting of
directed POCs and delineation of deficiencies is beyond the scope of
this rule.
Final Decision: After consideration of the public comments we
received, we are finalizing this section as proposed.
l. Directed In-Service Training (Sec. 488.1255)
We proposed at Sec. 488.1255, to outline the requirements for
conducting directed in-service training for hospice programs with
condition-level deficiencies. At proposed Sec. 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 Sec. 488.1255(a)(3), we proposed 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. We would 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 Sec. 488.1255(b), if the
hospice program did not achieve substantial compliance after such
training, we could impose one or more additional remedies. Before
imposing this remedy, we would provide appropriate notice to the
hospice program under proposed Sec. 488.1210(e).
Comment: Commenters were in support of the proposed directed plan
of correction and directed in-service training enforcement remedies
that align with the available home health alternative sanctions.
Response: We appreciate the support for the proposed directed plan
of correction and directed in-service training enforcement remedies
that align with the available home health alternative sanctions.
Final Decision: After consideration of the public comments we
received, we are finalizing this section as proposed.
m. Continuation of Payments to a Hospice Program With Deficiencies
(Sec. 488.1260)
We proposed at Sec. 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 would 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 proposed these three criteria at Sec. 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. We 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 Sec. 488.1265 if the
requirements at Sec. 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 proposed at Sec. 488.1230(d) that we
would terminate the provider agreement.
Comment: A commenter recommended that CMS modify the proposed
regulatory text at Sec. 488.1260(a) by replacing ``may'' with ``will''
to ensure continuity of the continuation of payments to a hospice
program with deficiencies.
Response: We respectfully disagree with the commenter's suggested
change
[[Page 62380]]
of ``may'' to ``will'' at Sec. 488.1260(a). The language for continued
payments is consistent with the language in the HHA regulation at Sec.
488.860. Therefore, the language at Sec. 488.1260(a) for continued
payments will read ``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.''
Final Decision: After consideration of the public comments we
received, we are finalizing this section with one modification. Because
we are finalizing Sec. 488.1240 to apply only to payments for all new
patient admissions, we are removing the parenthetical in proposed Sec.
488.1260(a)(1)(i) that excepted the suspension of all payment.
n. Termination of Provider Agreement (Sec. 488.1265)
At Sec. 488.1265(a), we proposed 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 Sec. 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 Sec. 488.1265(b), we 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 Sec. 488.1265(d)
we proposed using the procedures for terminating a hospice program at
Sec. 489.53 and providing appeal rights in accordance with 42 CFR part
489. Additionally, we proposed using the procedures for payments 30
days post termination for hospice programs at Sec. 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 (Sec. 489.55(a)(2)).
We did not receive comments on this proposal and therefore are
finalizing this provision without modification.
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
In the proposed rule, we sought input on the following steps that
would enable transformation of our quality measurement enterprise to be
fully digital (86 FR 19765):
1. What EHR/IT systems do you use and do you participate in a
health information exchange (HIE)?
2. How do you currently share information with other providers and
are there specific industry best practices for integrating SDOH
screening into EHR's?
3. 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?
4. 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?
5. 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?
6. What could be the potential use of FHIR dQMs that could be
adopted across all QRPs?
Most commenters supported the use and adoption of Fast Healthcare
Interoperative Resources (FHIR) Application Programming Interfaces
(APIs). Many commenters stressed the need for further work in
standardizing data that are part of clinical documents to exchange
information based on high-value use. Another requirement suggested by
commenters is to specify the defined set of FHIR-APIs and HL7 messages
that each health IT vendor must support to meet interoperability
standards of practice or both. Many commenters shared that we need to
consider providing incentives to working with EHR vendors that promote
practices that support interoperability. Commenters supported the
meaningful use framework and how it relates to promoting dQMs. They
note that HHAs and other PAC providers were not included in the HITECH
Act and therefore did not have the incentives as other provider
communities that are needed to support providers and vendors. A
commenter suggested that incentives need not be financial and that they
could be in the form of points via a value-based purchasing program.
Other incentives suggested included training and technical assistance
for providers with the lowest adoption of technology infrastructure.
Commenters requested there be a robust trial period before any dQM
adoption nationally. Ideally, commenters would prefer 6 months to 1
year from whenever final specifications around dQMs are made before
implementation. A commenter noted that family or caregivers play an
important role in older patients care and need to be included and
supported in any transition to more digital records as they support
patients. Some commenters also provided responses to questions about
their EHR systems and capabilities. We appreciate commenters' input on
this very important work.
While we are not responding to comments in response to this Request
for Information, we intend to use this input to inform future policy
related to Fast Healthcare Interoperability Resources (FHIR) in Support
of Digital Quality Measurement in Quality Programs.
B. Closing the Health Equity Gap in Post-Acute Care Quality Reporting
Programs--Request for Information
In the proposed rule, we sought public comment on the following:
As finalized in the HH PPS final rule (84 FR 60597 through
60608), HHAs will be required to report Standardized Patient Assessment
Data Elements on certain SDOH, includingrace, ethnicity, preferred
language, interpreter services, health literacy, transportation and
social isolation.\104\ We sought 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.
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\104\ In response to the COVID-19 PHE, CMS released a 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.
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Recommendations for how we 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
[[Page 62381]]
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 \105\ 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).
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\105\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
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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 of health to support care
delivery and decision-making.
Commenters consistently supported our focus on closing health
equity gaps in post-acute care, including under the HH QRP. Many
commenters shared that relevant data collection and appropriate
stratification are very important in addressing any health equity gaps.
Stratification of health outcomes would be very helpful to
organizations and some commenters supported providing home health
agencies with confidential reports that report quality measures
stratified by social risk factors. Many commenters shared their
strategies for addressing health disparities, noting that this was an
important commitment for many health provider organizations. Some
commenters who worked for HHAs note that they collect SDOH elements to
develop comprehensive and individualized care plans. Commenters also
shared that HHAs currently use OASIS data on payer information, race/
ethnicity, zip code, and age.
Commenters had recommendations for additional SDOH elements that
could strengthen data collection efforts. Many commenters suggest
capturing information related to food insecurity, income, education,
transportation, and housing. Other commenters suggested the data
collection and measurement of demographic characteristics such as
sexual orientation and gender identity (SOGI), language preference,
tribal membership, and disability status. Numerous commenters suggested
that for any data elements introduced, we need to ensure the format
align with other Federal agency best practices, such as indicators used
by the U.S. Census Bureau. Commenters also suggested that we need to
consider adopting the use of Z codes for SDOH on home health claims.
Some commenters emphasized balancing the need to have targeted new data
elements that capture necessary information on non-clinical patient
characteristics without introducing undue burden with too many new,
untested items. Some commenters proposed working with existing efforts
in the public and private sector that promote health equity by
addressing social determinants of health. A commenter cautioned we from
the inclusion of social risk factors without careful methodological
considerations into risk adjustment models. They note inclusion of some
social risk factors could perpetuate low performance expectations.
Commenters noted that the COVID-19 PHE promoted use of more digital
health tools and that this expansion need to be made permanent to help
support the reduction in the equity gap. Some also highlighted how the
PHE underscores the need for better data collection and analysis of
demographic data to aid in addressing disparities in outcome and care.
Some commenters are against indirect estimation methods and suggest
that we need to work on a timeline for introducing any SDOH data
elements needed and to focus on direct estimation. A commenter shared
that it is important to consider the needs of American Indian/Alaska
Natives in any data collection strategy.
While we are not responding to specific comments submitted in
response to this Health Equity request for information (RFI) in this
final rule, we appreciate all of the comments and interest in this
topic. We will continue to take all concerns, comments, and suggestions
into account as we continue work to address and develop policies on
this important topic. It is our hope to provide additional stratified
information to HHAs related to race and ethnicity if feasible. The
provision of stratified measure results will allow HHAs to understand
how they are performing with respect to certain patient risk groups, to
support these providers in their efforts to ensure equity for all of
their patients, and to identify opportunities for improvements in
health outcomes.
IX. Revised Compliance Date for Certain Reporting Requirements Adopted
for Inpatient Rehabilitation Facility (IRF) Quality Reporting Program
(QRP) and Long-Term Care Hospital (LTCH) QRP
A. 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 1
full fiscal year after the end of the COVID-19 PHE. We 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 1 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 1 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
[[Page 62382]]
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, we 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,
we 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. We 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 Sec.
412.622(a)(4)(ii). In the FY 2021 IRF PPS final rule (85 FR 48445
through 48447),\106\ we removed the post-admission 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.\107\ We also believe that much more is
known about COVID-19 than we did at the time IFC-2 was
finalized.108 109 110 111
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\106\ In the FY 2022 HH proposed rule (86 FR 35874), CMS
provided an incorrect citation and is correcting that error here and
throughout this final rule.
\107\ CDC COVID Data Tracker. Retrieved from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\108\ Here'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-with-vaccines-and-treatments-for-covid-19.
\109\ COVID research: A year of scientific milestones. Nature.
May 5, 2021. Retrieved from: https://www.nature.com/articles/d41586-020-00502-w.
\110\ Clinical 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-severely-ill-hospitalized-covid-19-patients-begins.
\111\ COVID-19 Treatment Guidelines. National Institutes of
Health. Updated April 21, 2021. Retrieved from: https://www.covid19treatmentguidelines.nih.gov/whats-new/.
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Based upon other flexibilities such as the previous examples, the
increase in knowledge IRF providers have about treating patients with
COVID-19 \112\ 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 (that were not
available at the time the 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.\113\
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\112\ Ehsanian R, Workman J, Jones D, et al. Free-standing 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/.
\113\ https://www.healthaffairs.org/do/10.1377/hblog20201214.543463/full/.
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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/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government).
3. Collection of 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 proposed 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 we 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 proposed 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, we will provide the
training and education for IRFs to be prepared for this implementation
(84 FR 39119 through 39147). In addition, if we adopt an October 1,
2022 compliance date, we would release a draft of the updated version
of the IRF-PAI, IRF-PAI V4.0, in early 2022.
Based upon our evaluation, we proposed that IRFs 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 proposed that IRFs begin collecting data on the two TOH
measures beginning with discharges on October 1, 2022. We also proposed
that IRFs 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 invited public comment on these proposals.
Comment: Many commenters raised concerns with revising the
compliance date from October 1st of the year that is at least 1 full
fiscal year after the end of the PHE to October 1, 2022, given the
current increase in the number of COVID-19 cases across the nation.
Several commenters also stated CMS was too optimistic about the COVID-
19 data and IRFs' readiness to train staff on
[[Page 62383]]
the IRF-PAI V4.0. They point to the CDC's Daily Tracker which shows a
7-day average of new COVID-19 cases having increased by >100,000 since
the CY 2022 HH PPS proposed rule (86 FR 35874) was published on July 7,
2021.
Response: As stated in section IX.A. 2 of the CY 2022 HH PPS
proposed rule (86 FR 35983 through 35984), CMS has provided IRFs a
number of flexibilities to accommodate the COVID-19 PHE, including
delaying 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 Standardized Patient Assessment Data
Elements (85 FR 27595 through 27596). We also waived the IRF QRP
reporting requirements for Q1 (January 1, 2020 through March 31, 2020)
and Q2 (April 1, 2020 through June 30, 2020) and modified the required
face-to-face visits in IRF such that they could be completed by
telehealth (42 CFR 412.622(a)(3)(iv) and 412.29(e)) during the PHE for
COVID-19. Additionally, we also made the waiver on the post-admission
physician evaluation requirement permanent beginning October 1, 2021,
in the FY 2021 IRF PPS final rule (85 FR 48445 through 48447). We
believe we have provided a number of flexibilities to provide relief to
IRFs throughout the PHE. We have also previously provided IRFs with the
necessary tools they would need to implement the new IRF PAI 4.0,
including release of the item set in 2019 and draft data specifications
in early 2020. If this proposal is finalized, we will continue to
provide IRFs with the tools they need well in advance of the
implementation of the IRF PAI V4.0.
Despite the COVID-19 PHE, we must maintain its commitment to the
quality of care for all patients, and we continue to believe that the
collection of the Standardized Patient Assessment Data Elements and TOH
Information measures will contribute to this effort. That includes
staying committed to achieving health equity by improving data
collection to better measure and analyze disparities across programs
and policies 114 115 116 117 118 119 and improving the
quality of care in IRFs through a reduction in preventable adverse
events. Health information, such as medication information, that is
incomplete or missing increases the likelihood of a patient or resident
safety risk, and is often life-
threatening.120 121 122 123 124 125 Poor communication and
coordination across health care settings contributes to patient
complications, hospital readmissions, emergency department visits and
medication errors.126 127 128 129 130 131 132 133 134 135
While we understand that there are concerns related to the timeline
proposed, we do not believe that further delaying the data collection
is an actionable solution to these concerns.
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\114\ Centers for Medicare & Medicaid Services. CMS Quality
Strategy. 2016. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\115\ Report to Congress: Improving Medicare Post-Acute 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-to-Congress-IMPACT-ACT-of-2014.pdf.
\116\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018.
\117\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\118\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\119\ Poteat 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.
\120\ Kwan, J.L., Lo, L., Sampson, M., & Shojania, K.G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\121\ Boockvar, K.S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K.A., Nebeker, J.R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\122\ Bell, C.M., Brener, S.S., Gunraj, N., Huo, C., Bierman,
A.S., Scales, D.C., & Urbach, D.R., ``Association of ICU or hospital
admission with unintentional discontinuation of medications for
chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\123\ Basey, A.J., Krska, J., Kennedy, T.D., & Mackridge, A.J.,
``Prescribing errors on admission to hospital and their potential
impact: a mixed-methods study,'' BMJ Quality & Safety, 2014, Vol.
23(1), pp. 17-25.
\124\ Desai, R., Williams, C.E., Greene, S.B., Pierson, S., &
Hansen, R.A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
\125\ Boling, P.A., ``Care transitions and home health care,''
Clinical Geriatric Medicine, 2009, Vol. 25(1), pp. 135-48.
\126\ Barnsteiner, J.H., ``Medication Reconciliation: Transfer
of medication information across settings--keeping it free from
error,''
\127\ Arbaje, A.I., Kansagara, D.L., Salanitro, A.H., Englander,
H.L., Kripalani, S., Jencks, S.F., & Lindquist, L.A., ``Regardless
of age: incorporating principles from geriatric medicine to improve
care transitions for patients with complex needs,'' Journal of
General Internal Medicine, 2014, Vol. 29(6), pp. 932-939.
\128\ Jencks, S.F., Williams, M.V., & Coleman, E.A.,
``Rehospitalizations among patients in the Medicare fee-for-service
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp.
1418-1428.
\129\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
\130\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling app roach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\131\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D.C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\132\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
\133\ Kitson, N.A., Price, M., Lau, F.Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling app roach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\134\ Forster, A.J., Murff, H.J., Peterson, J.F., Gandhi, T.K.,
& Bates, D.W., ``The incidence and severity of adverse events
affecting patients after discharge from the hospital.'' Annals of
Internal Medicine, 2003,138(3), pp. 161-167.
\135\ King, B.J., Gilmore-Bykovsky, A.L., Roiland, R.A.,
Polnaszek, B.E., Bowers, B.J., & Kind, A.J. ``The consequences of
poor communication during transitions from hospital to skilled
nursing facility: a qualitative study,'' Journal of the American
Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
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Comment: A commenter stated that CMS' original postponement from
IFC-2 would likely have called for full adoption by October 1, 2023 and
they believe this is still an appropriate adoption date.
Response: We interpret the commenter's reference to ``full
adoption'' to refer to the adoption of the IRF-PAI V4.0, which includes
the items for the TOH-Patient measure, the TOH-Provider measure, and
the Standardized Patient Assessment Data Elements. We believe that as
the healthcare community continues to learn about the enormous impact
that social determinants of health (SDOH) and social risk factors
(SRFs) have on patient health and health outcomes,\136\ it becomes more
critical to collect this in order to better understand the impact of
the PHE on our healthcare system, as well as how to improve the
inequities that the PHE has made so visible. We believe it will help
IRFs, physicians, and other practitioners caring for patients in IRFs
better prepare for the complex and resource-intensive care needs of
patients with COVID-19, which will be particularly important during
continued surges of this virus or new and emerging viruses. If
finalized, this proposal would effectively grant a 2-year delay to the
originally planned release of the IRF-PAI V4.0, a delay we granted due
to the PHE. We believe that there has been a sufficient timeframe for
[[Page 62384]]
IRFs to adjust to the change in care patterns associated with the PHE.
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\136\ Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health
Rankings: Relationships Between Determinant Factors and Health
Outcomes. Am J Prev Med. 2016 Feb;50(2):129-35. Available at:
https://pubmed.ncbi.nlm.nih.gov/26526164/. Accessed 9/1/21.
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Comment: A commenter stated that the Delta variant, and the
potential for other variants, has undermined the knowledge and
experience gained by IRFs earlier in the pandemic. Commenters stated a
continued delay would provide IRFs the necessary capacity to
accommodate additional surges.
Response: We understand the conditions under which IRFs are working
to address the number of new COVID-19 cases resulting from the Delta
variant. We disagree with the commenter, however, that the knowledge
and experience IRFs have gained since the beginning of the pandemic has
been undermined by the Delta variant. The Delta variant is a mutation
of the original SARS-CoV-2 strain, rather than a novel virus as COVID-
19 was when it emerged in January of 2020. While the CDC has described
the Delta variant as more transmissible than the Alpha COVID-19
virus,\137\ many of the symptoms are similar.\138\ The methods of
reducing transmission of the Delta variant are also similar, that is
indoor masking, social distancing, and vaccination.\139\ Currently,
there are multiple treatments 140 141 for COVID-19 and
vaccines that are either authorized under a Food and Drug
Administration's (FDA) Emergency Use Authorization 142 143
or have approval from FDA.\144\
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\137\ Delta Variant: What We Know about the Science. Available
at: https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html Accessed 9/1/2021.
\138\ What Are the Symptoms of the COVID-19 Delta Variant?
Available at: https://www.emedicinehealth.com/what_are_the_symptoms_of_covid19_delta_variant/article_em.htm.
Accessed 9/1/2021.
\139\ Things to Know About the Delta Variant. Available at:
https://www.yalemedicine.org/news/5-things-to-know-delta-variant-covid. Accessed 9/1/2021.
\140\ National Institutes of Health COVID-19 Treatment
Guidelines. Available at: https://www.covid19treatmentguidelines.nih.gov/. Accessed 9/9/2021.
\141\ FDA Approves First Treatment for COVID-19. October 22,
2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19. Accessed 9/9/
2021.
\142\ U.S. Food and Drug Administration (2021). Janssen Biotech,
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at
https://www.fda.gov/media/146303/download. Accessed 9/9/2021.
\143\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc.
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download. Accessed 9/9/2021.
\144\ FDA Approves First COVID-19 Vaccine [bond] FDA, available
at https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. Accessed 9/03/21. The Pfizer-BioNTech
vaccine also continues to be available under EUA. U.S. Food and Drug
Administration (2021). Comirnaty and Pfizer-BioNTech COVID-19
Vaccine. Accessed 9/28/2021.
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Comment: A commenter stated that if the PHE was a valid reason to
delay implementation of the TOH measures and certain Standardized
Patient Assessment Data Elements a year ago, the recent surge is a
valid reason to maintain the delay.
Response: We disagree with the commenter. As described in section
XI.A.1 of the CY 2022 HH PPS proposed rule (86 FR 35983 through 35984),
at the time we finalized the policy in the IFC-2 (85 FR 27550), we were
in the initial months of the COVID-19 PHE and very little was known
about the COVID-19 virus. We believed the delay in collection of the
TOH Information measures and Standardized Patient Assessment Data
Elements was necessary in order to allow IRFs to focus on patient care
and staff safety during a time when very little was known about COVID-
19. However, the COVID-19 PHE has illustrated the important need for
these TOH Information measures and Standardized Patient Assessment Data
Elements under the IRF QRP. The PHE's disproportionate impact among
black, Latino, and American Indian and Alaska Native (AI/AN) persons
145 146 demonstrates the importance of analyzing this impact
in order to improve quality of care within IRFs especially during a
crisis. As stated in section VII.F of the FY 2022 IRF PPS proposed rule
(86 FR 19110 through 19112), one important strategy for addressing
these important inequities is by improving data collection to allow for
better measurement and reporting on equity across post-acute care
programs and policies, and the data collected will 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/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government).
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\145\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\146\ Ochieng 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-and-medicare/.
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Currently, there are multiple treatments 147 148 for
COVID-19, and vaccines that are either authorized under FDA's Emergency
Use Authorization 149 150 or have approval from FDA.\151\ As
of August 13, 2021, 82.2% of the population 65 years of age or older
and 64.4% of the population 18 years of age or older have been fully
vaccinated.\152\
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\147\ National Institutes of Health COVID-19 Treatment
Guidelines. Available at: https://www.covid19treatmentguidelines.nih.gov/. Accessed 9/9/2021.
\148\ FDA Approves First Treatment for COVID-19. October 22,
2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19. Accessed 9/9/
2021.
\149\ U.S. Food and Drug Administration (2021). Janssen Biotech,
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at
https://www.fda.gov/media/146303/download. Accessed 9/9/2021.
\150\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc.
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download. Accessed 9/9/2021.
\151\ FDA Approves First COVID-19 Vaccine. FDA. Available at:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. Accessed 9/03/21. The Pfizer-BioNTech
vaccine also continues to be available under EUA. U.S. Food and Drug
Administration (2021). Comirnaty and Pfizer-BioNTech COVID-19
Vaccine. Accessed 9/28/2021.
\152\ COVID-19 Vaccinations in the United States. Available at:
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Accessed 9/9/2021.
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Comment: Several commenters stated implementing the IRF-PAI V4.0
would divert critical patient care resources at a time when IRFs are
struggling to keep up with current documentation requirements. They
raised concerns that having to train nursing staff to collect and
report these data would divert their attention away from direct patient
care. A commenter stated that hospitals are still requiring social
distancing and limiting large group gatherings, so the logistics of
training would be challenging. A commenter stated that implementing the
new assessment tool at this time may increase the risk for patient-care
errors, while another commenter stated they would have no means to
dedicate staff to the task of training which would defeat the purpose
of collecting the information.
Response: As described in section IX.A.2. of this final rule, we
granted IRF providers several waivers related to documentation in order
to ease burden during the PHE, and many of these are still in effect.
We are very mindful of burden that may occur from the collection and
reporting of data. Both the TOH-Patient measure and TOH-Provider
measure are comprised of one item, and further, the activities
associated with the measure align with existing requirements related to
transferring information at the time of discharge to safeguard patients
(84 FR 51882 and Sec. 482.43). Additionally, TEP feedback and pilot
testing of the items
[[Page 62385]]
did not find the burden of reporting to be significant.\153\
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\153\ Transfer of Health Information TEP Meeting 4--June 2018.
Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meeting-4-June2018.pdf.
Accessed 9/9/2021.
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The new Standardized Patient Assessment Data Element items in the
IRF-PAI 4.0 are also reflective of patient characteristic that
providers are likely already gathering in order to meet hospital
conditions of participation, such as patient's preferred language,
race, ethnicity, hearing, vision, health literacy, pain, high-risk drug
classes and cognitive function.
We also understand provider's concerns with developing training
materials for the TOH-Patient measure and TOH-Provider measure items
and the Standardized Patient Assessment Data Elements. We plan to
provide multiple training resources and opportunities for IRFs to take
advantage of, reducing the burden to IRFs in creating their own
training resources. These training resources may include online
learning modules, tip sheets, questions and answers documents, and/or
recorded webinars and videos, and would be available to providers in
early 2022, allowing IRFs several months to ensure their staff take
advantage of the learning opportunities. Having the materials online
and on-demand would also eliminate the need for large group gatherings,
a concern raised by some commenters. The IRF QRP Helpdesk would also be
available for providers to submit their follow up questions by email,
further enhancing the educational resources.
Comment: We received a comment stating that implementing the IRF-
PAI 4.0 would require additional staffing, specifically nursing staff,
at a time when there is a pandemic-induced nursing staff shortage,
which in some areas is so critical that IRF beds have been reduced. A
commenter noted that although there are multiple positions open at
their IRF, they have had no applicants. This same commenter reported
they have had to reinstitute COVID emergency staffing registered nurse
(RN)-to-patient ratios, and without a foreseeable end in the surge in
cases, staff leadership cannot turn their resources and attention to
the task of training. They suggested that not finalizing the proposal
would minimize administrative and reporting requirements and provide an
opportunity to recover from the pandemic's effects on the workforce.
Response: We interpret the commenter's concern to be associating
the nursing shortage with the COVID-19 pandemic. According to the
Centers for Disease Control and Prevention's (CDC) COVID Data Tracker
Weekly review on October 1, 2021,\154\ the current 7-day moving average
of daily cases has decreased 13.3% compared to the previous 7-day
moving average. Additionally, COVID-19 cases have been steadily
declining since January 2021. Despite an uptick in weekly reported
cases in September, the height of new cases at that time was still 36%
less than the numbers reported in January 2021.\155\ According to the
CDC's forecast modeling, new cases are estimated to continue to decline
another 30% in the next four weeks. The impacts of the COVID-19 PHE on
the healthcare system, including staffing shortages, make it especially
important now to monitor quality of care.\156\ Still, we are mindful of
burden that may occur from the collection and reporting of our
measures. We emphasize, however, that that TOH Information Provider-PAC
and TOH Information Patient-PAC measures consist of one item each, and
further, the activities associated with the measures align with the
existing requirements related to transferring information at the time
of discharge to safeguard patients. Additionally, as stated in the FY
2020 IRF PPS final rule (84 FR 39054 through 39173), we convened a
Technical Expert Panel (TEP) \157\ and conducted a pilot test.\158\
Both the TEP feedback and the pilot participants found the burden of
reporting not to be significant.
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\154\ https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
\155\ Centers for Disease Control and Prevention. COVID-19
Forecasts: Cases. Available at: https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/forecasts-cases.html. Accessed
September 27, 2021.
\156\ Nursing and Patient Safety. Agency for Healthcare Research
and Quality. April 21, 2021. Available at: https://psnet.ahrq.gov/primer/nursing-and-patient-safety. Accessed 10/4/2021.
\157\ Transfer of Health Information TEP Meeting 4--June 2018.
Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meeting-4-June2018.pdf.
Accessed 9/1/2021.
\158\ Transfer of Health Information 2018 Pilot Test Summary
Report. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-Pilot-Test-Summary-Report_Final_Feb2018.pdf. Accessed 9/1/2021.
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We have strived to balance the scope and level of detail of the
data elements against the potential burden placed on IRFs. We plan to
provide multiple training resources and opportunities for IRFs to take
advantage of, which will reduce the burden to IRFs. We plan to make
these training resources available to IRFs in early 2022.
Comment: Several commenters pointed out the lack of Information
Systems (IT) personnel as a barrier to being able to implement the IRF-
PAI V4.0 on October 1, 2022. They state that implementing the IRF-PAI
V4.0 would require new flowsheets, interfaces, and reports to inform
the new version of the assessment instrument, and they are limited in
their resources. They state that IT systems and personnel had to
quickly pivot to developing virtual platforms for care during the PHE,
and/or develop platforms and reports to implement mandatory and time-
sensitive COVID-19-related tracking requirements. A commenter noted
that there are also 2020 ``maintenance releases'' that have been
delayed due to the PHE and staffing shortages. As a result, these
commenters do not believe they have the operational resources to
dedicate to the investment of retooling their electronic health record
for the IRF-PAI V4.0.
Response: While we acknowledge there will be some updates required
of IT vendors and systems, we believe a significant portion of the work
has already been completed. For example, we posted a change table in
November 2019 illustrating the changes that would occur to the IRF-PAI
with the transition from the IRF-PAI 3.0 to 4.0. In March 2020, we
posted the IRF-PAI Draft Technical Data Submission Specifications. The
IRF-PAI 4.0 was not postponed due to the PHE until June 17, 2020, fewer
than 4 months before it was to be implemented October 1, 2020.
Therefore, we believe that most IRFs would have already made the
necessary enhancements to their electronic medical records and
flowsheets in preparation for the transition. We plan to provide the
final draft specifications and release that to providers and vendors in
late 2021 or when technically feasible, which would give providers just
under 1 year to build their necessary IT programs.
Comment: Several commenters stated that if CMS finalized the
October 1, 2022, date for the collection of the TOH Information to the
Patient-PAC measure, the TOH Information to the Patient-Provider
measure, and the Standardized Patient Assessment Data Elements, they
would have to divert resources away from the tasks associated with
patient care and instead put the resources in training nursing staff to
complete the new assessment. A commenter stated they believe the
benefit to CMS of having this information to study is significantly
outweighed by the burden imposed on IRFs.
[[Page 62386]]
Response: We would like to clarify that CMS proposed to begin
collecting the TOH Information to the Patient-PAC measure, the TOH
Information to the Patient-Provider measure and the Standardized
Patient Assessment Data Elements to support our responsibility to
monitor and ensure quality of care for patients. Additionally, this
information will provide actionable data on which IRFs can improve
health care outcomes.
We disagree that the benefit of having this information is
outweighed by the burden. As stated earlier, we plan to provide
multiple training resources and opportunities for IRFs to take
advantage of, which will reduce the burden to IRFs. We plan to make
these training resources available to IRFs in early 2022, allowing IRFs
several months to ensure their staff take advantage of the learning
opportunities, and to allow IRFs to spread the cost of training out
over several quarters.
Comment: A commenter stated that proposing the implementation of
the IRF-PAI V4.0 so soon after CMS' request for information (RFI) on
creating new standardized data collection elements across the continuum
of care (not just post-acute care) in the IRF PPS proposed rule (86 FR
19110 through 19112) created confusion for providers. They believe it
would create confusion and unnecessary administrative burden for CMS to
add data elements to the IRF-PAI V4 because they are available, only to
replace them with more reliable elements based on the feedback received
to the FY 2022 IRF RFI.
Response: To clarify, the Standardized Patient Assessment Data
Elements that would be collected in the IRF-PAI V4.0 were finalized in
the FY 2020 IRF PPS final rule (84 FR 4 FR 39109 through 39161). The
request for information published in section VII.F. of the FY 2022 IRF
PPS proposed rule (86 FR 19110 through 19112) requested public comment
on recommendations for quality measures or measurement domains that
address health equity as well as additional items that could be used to
assess health equity in the care of IRF patients, which may or may not
include Standardized Patient Assessment Data Elements. Therefore, we do
not anticipate unnecessary administrative burden as a result of the
feedback received to the FY 2022 IRF RFI.
Comment: A commenter noted it was unclear if CMS' proposal intended
to implement the full scope of the IRF-PAI version 4.0, or only those
Standardized Patient Assessment Data Elements and the two new TOH
measures discussed in the proposal. They reference the original change
table CMS provided back in 2019. For example, the data elements for
IRF-PAI V.4.0 in section O starting on page 26 of the change table are
not addressed by CMS's proposed scope of adoption. The commenter asked
CMS to clarify what data elements would be adopted to support their
proposal.
Response: We believe the commenter is referencing the document
titled, ``Change Table for Final IRF-PAI Version 4.0--Effective date:
October 1, 2020'', that was posted to the CMS QRP website on November
21, 2019.\159\ This change table reflects the reporting requirements
under the IRF QRP that were finalized in the FY 2020 IRF PPS Final
Rule. Our proposal is consistent with the reporting requirements
finalized in the FY 2020 IRF PPS Rule; specifically, IRFs would begin
using the IRF Patient Assessment Instrument (PAI) V4.0 to report the
TOH Information to Provider-PAC and the TOH Information to Patient--PAC
measures and certain Standardized Patient Assessment Data Elements. If
finalized, we would release an updated draft of the IRF-PAI V.4.0 and
accompanying IRF-PAI V.4.0 manual in early 2022.
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\159\ File available here: https://www.cms.gov/files/document/final-irf-pai-version-40-change-table-1.pdf and on the IRF-PAI and
IRF-PAI Manual webpage in the Downloads section at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-PAI-and-IRF-PAI-Manual.
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Comment: A commenter acknowledged that CMS has the authority to
issue proposals through a variety of avenues, but requested CMS include
proposals impacting IRF payment or the Quality Reporting Program (QRP)
in the annual IRF Prospective Payment System (PPS) rulemaking in order
to avoid confusion for stakeholders.
Response: We thank the commenter for the suggestion and will take
it under consideration. We note, however, that an announcement was
posted to the IRF QRP Spotlights and Announcements \160\ webpage on
June 28, 2021, an announcement was sent from the PAC listserv.
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\160\ Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Spotlights-Announcements. Accessed 10/4/2021.
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Final Decision: After careful consideration of the comments
received, we are finalizing our proposal that IRFs begin collecting the
TOH Information to Provider-PAC measure, the TOH Information to the
Patient-PAC measure, and 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.
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 1 full fiscal year
after the end of the COVID-19 PHE. We 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 1 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 1 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
[[Page 62387]]
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, we have 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, we 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. We
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, we 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.\161\ We also believe that much more is
known about COVID-19 than at the time we finalized IFC-
2.162 163 164 165
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\161\ CDC COVID Data Tracker. Retrieved from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\162\ Here'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-with-vaccines-and-treatments-for-covid-19.
\163\ COVID research: a year of scientific milestones. Nature.
May 5, 2021. Retrieved from: https://www.nature.com/articles/d41586-020-00502-w.
\164\ Clinical 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-severely-ill-hospitalized-covid-19-patients-begins.
\165\ COVID-19 Treatment Guidelines. National Institutes of
Health. Updated April 21, 2021. Retrieved from: https://www.covid19treatmentguidelines.nih.gov/whats-new/.
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Based upon other flexibilities such as the previous examples, the
increase in knowledge LTCH providers have about treating patients with
COVID-19 \166\ 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.\167\
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\166\ Ehsanian R, Workman J, Jones D, et al. Free-standing 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/.
\167\ https://www.healthaffairs.org/do/10.1377/hblog20201214.543463/full/.
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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.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government).
3. Collection of 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 proposed 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, 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 2-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 we 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 proposed 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, we will provide
the training and education for LTCHs to be prepared for this
implementation (84 FR 42540 through 42560). In addition, if we adopt an
October 1, 2022, compliance date, we stated that we would release a
draft of the updated version of the LCDS, LCDS V5.0, in early 2022.
Based upon our evaluation, we proposed that LTCHs 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
proposed that accordingly, LTCHs begin collecting data on the two TOH
measures beginning with discharges on October 1, 2022. We also proposed
that LTCHs 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 invited public comment on these proposals.
Comment: Several commenters raised concerns with revising the
compliance date from October 1st of the year that is at least 1 full
year after the end of the PHE to October 1, 2022, given the current
increase in the number of COVID-19 cases across the nation. Commenters
also stated CMS was too optimistic about the COVID-19 data and LTCHs'
readiness to train staff on the LCDS V5.0. They point to the CDC's
Daily Tracker which shows a 7-day average of new COVID-19 cases having
increased by >100,000 since the CY 2022 HH PPS proposed rule (86 FR
35874) was published on July 7, 2021.
[[Page 62388]]
Response: As stated in section IX.B. 2 of the CY 2022 HH PPS
proposed rule (86 FR 35984 through 35985), we have provided LTCHs a
number of flexibilities to accommodate the COVID-19 PHE. In addition to
delaying the adoption of the updated version of the LCDSV5.0 with which
LTCHs would have used to report the TOH measures and certain
Standardized Patient Assessment Data Elements (85 FR 27595 through
27596), we also waived the LTCH QRP reporting requirements for Q1
(January 1, 2020 through March 31, 2020) and Q2 (April 1, 2020 through
June 30, 2020). Additionally, we waived the requirement at 42 CFR
482.43(a)(8), 482.61(e), and 485.642(a)(8) to provide detailed
information regarding discharge planning, and waived the 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. Both of these waivers, as well as
others, remain in place today. We believe we have provided a number of
flexibilities to provide relief to LTCHs throughout the PHE. We have
also previously provided LTCHs with the necessary tools they would need
to implement the new LTCH V5.0, including release of the item set in
2019 and draft data specifications in early 2020. If this proposal is
finalized, we will continue to provide LTCHs with the tools they need
well in advance of the implementation of the LTCH V5.0.
Despite the ongoing COVID-19 PHE, we must maintain commitment to
the quality of care for all patients, and we continue to believe that
the collection of the Standardized Patient Assessment Data Elements and
TOH Information measures will contribute to this effort. That includes
staying committed to achieving health equity by improving data
collection to better measure and analyze disparities across programs
and policies168 169 170 171 172 173 and improving the
quality of care in LTCHs through a reduction in preventable adverse
events. Health information, such as medication information, that is
incomplete or missing increases the likelihood of a patient or resident
safety risk, and is often life-
threatening.174 175 176 177 178 179 Poor communication and
coordination across health care settings contributes to patient
complications, hospital readmissions, emergency department visits and
medication errors.180 181 182 183 184 185 186 187 188 189
While we understand that there are concerns related to the timeline
proposed, we do not believe that further delaying the data collection
is an appropriate response to these concerns. As the healthcare
community continues to learn about the enormous impact that social
determinants of health (SDOH) and social risk factors (SRFs) have on
patient health and health outcomes,\190\ it becomes more critical for
Medicare to collect this information. The information is extremely
important to understanding the impact of the PHE on our healthcare
system, and how to improve the inequities the PHE has made so visible,
and we believe it will help LTCHs better prepare for the complex and
resource-intensive care needs of patients with COVID-19, which will be
particularly important during continued surges of this virus or new and
emerging viruses. If finalized, this proposal would effectively grant a
2-year delay to the originally planned release of the LCDS V5.0, a
delay we granted due to the PHE. We believe that there has been a
sufficient timeframe for LTCHs to adjust to the change in care patterns
associated with the PHE.
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\168\ Centers for Medicare & Medicaid Services. CMS Quality
Strategy. 2016. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\169\ Report to Congress: Improving Medicare Post-Acute 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-to-Congress-IMPACT-ACT-of-2014.pdf.
\170\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018.
\171\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\172\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\173\ Poteat 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.
\174\ Kwan, J. L., Lo, L., Sampson, M., & Shojania, K. G.,
``Medication reconciliation during transitions of care as a patient
safety strategy: a systematic review,'' Annals of Internal Medicine,
2013, Vol. 158(5), pp. 397-403.
\175\ Boockvar, K. S., Blum, S., Kugler, A., Livote, E.,
Mergenhagen, K. A., Nebeker, J. R., & Yeh, J., ``Effect of admission
medication reconciliation on adverse drug events from admission
medication changes,'' Archives of Internal Medicine, 2011, Vol.
171(9), pp. 860-861.
\176\ Bell, C. M ., Brener, S. S., Gunraj, N., Huo, C., Bierman,
A. S., Scales, D. C., & Urbach, D. R., ``Association of ICU or
hospital admission with unintentional discontinuation of medications
for chronic diseases,'' JAMA, 2011, Vol. 306(8), pp. 840-847.
\177\ Basey, A. J., Krska, J., Kennedy, T. D., & Mackridge, A.
J., ``Prescribing errors on admission to hospital and their
potential impact: a mixed-methods study,'' BMJ Quality & Safety,
2014, Vol. 23(1), pp. 17-25.
\178\ Desai, R., Williams, C. E., Greene, S. B., Pierson, S., &
Hansen, R. A., ``Medication errors during patient transitions into
nursing homes: characteristics and association with patient harm,''
The American Journal of Geriatric Pharmacotherapy, 2011, Vol. 9(6),
pp. 413-422.
\179\ Boling, P. A., ``Care transitions and home health care,''
Clinical Geriatric Medicine, 2009, Vol. 25(1), pp. 135-48.
\180\ Barnsteiner, J. H., ``Medication Reconciliation: Transfer
of medication information across settings--keeping it free from
error,''
\181\ Arbaje, A. I., Kansagara, D. L., Salanitro, A. H.,
Englander, H. L., Kripalani, S., Jencks, S. F., & Lindquist, L. A.,
``Regardless of age: incorporating principles from geriatric
medicine to improve care transitions for patients with complex
needs,'' Journal of General Internal Medicine, 2014, Vol. 29(6), pp.
932-939.
\182\ Jencks, S. F., Williams, M. V., & Coleman, E. A.,
``Rehospitalizations among patients in the Medicare fee-for-service
program,'' New England Journal of Medicine, 2009, Vol. 360(14), pp.
1418-1428.
\183\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
\184\ Kitson, N. A., Price, M., Lau, F. Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling app roach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\185\ Mor, V., Intrator, O., Feng, Z., & Grabowski, D. C., ``The
revolving door of rehospitalization from skilled nursing
facilities,'' Health Affairs, 2010, Vol. 29(1), pp. 57-64.
\186\ Institute of Medicine. ``Preventing medication errors:
quality chasm series,'' Washington, DC: The National Academies Press
2007. Available at https://www.nap.edu/read/11623/chapter/1.
\187\ Kitson, N. A., Price, M., Lau, F. Y., & Showler, G.,
``Developing a medication communication framework across continuums
of care using the Circle of Care Modeling app roach,'' BMC Health
Services Research, 2013, Vol. 13(1), pp. 1-10.
\188\ Forster, A. J., Murff, H. J., Peterson, J. F., Gandhi, T.
K., & Bates, D. W., ``The incidence and severity of adverse events
affecting patients after discharge from the hospital.'' Annals of
Internal Medicine, 2003,138(3), pp. 161-167.
\189\ King, B. J., Gilmore[hyphen] Bykovsky, A. L., Roiland, R.
A., Polnaszek, B. E., Bowers, B. J., & Kind, A. J. ``The
consequences of poor communication during transitions from hospital
to skilled nursing facility: a qualitative study,'' Journal of the
American Geriatrics Society, 2013, Vol. 61(7), 1095-1102.
\190\ Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health
Rankings: Relationships Between Determinant Factors and Health
Outcomes. Am J Prev Med. 2016 Feb;50(2):129-35. Available at:
https://pubmed.ncbi.nlm.nih.gov/26526164/. Accessed 9/1/21.
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Comment: Another commenter stated that if the PHE was a valid
reason to delay implementation of the TOH measures and certain
Standardized Patient Assessment Data Elements a year ago, the recent
surge is a valid reason to maintain the delay.
Response: We disagree with the commenter. As described in section
XI.A.1 of the CY 2022 HH PPS proposed rule (86 FR 35983 through 35984),
at the time we finalized the policy in the IFC-2 (85 FR 27550), we were
in the initial months of the COVID-19 PHE and very little was known
about the COVID-19 virus. We believed the delay in
[[Page 62389]]
collection of the TOH Information measures and Standardized Patient
Assessment Data Elements was necessary in order to allow LTCHs to focus
on patient care and staff safety during a time when very little was
known about COVID-19. However, the COVID-19 PHE has illustrated the
important need for these TOH Information measures and Standardized
Patient Assessment Data Elements under the LTCH QRP. The PHE's
disproportionate impact among black, Latino, and American Indian and
Alaska Native (AI/AN) persons 191 192 demonstrates the
importance of analyzing this impact in order to improve quality of care
within LTCHs especially during a crisis. As stated in section IX.E.7 of
the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25616 through 25618) one
important strategy for addressing these important inequities is by
improving data collection to allow for better measurement and reporting
on equity across post-acute care programs and policies, and the data
collected will 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/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government).
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\191\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\192\ Ochieng 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-and-medicare/.
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Currently, there are multiple treatments193 194 for
COVID-19, and vaccines that are either authorized through FDA's
Emergency Use Authorization 195 196 or have approval from
FDA.\197\ As of August 13, 2021, 82.2% of the population 65 years of
age or older and 64.4% of the population 18 years of age or older have
been fully vaccinated.\198\
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\193\ National Institutes of Health COVID-19 Treatment
Guidelines. Available at: https://www.covid19treatmentguidelines.nih.gov/. Accessed 9/9/2021.
\194\ FDA Approves First Treatment for COVID-19. October 22,
2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19. Accessed 9/9/
2021.
\195\ U.S. Food and Drug Administration (2021). Janssen Biotech,
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at
https://www.fda.gov/media/146303/download. Accessed 9/9/2021.
\196\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc.
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download. Accessed 9/9/2021.
\197\ FDA Approves First COVID-19 Vaccine [verbar] FDA. Accessed
9/03/21. The Pfizer-BioNTech vaccine also continues to be available
under EUA. U.S. Food and Drug Administration (2021). Comirnaty and
Pfizer-BioNTech COVID-19 Vaccine. Accessed 9/28/2021.
\198\ COVID-19 Vaccinations in the United States. Available at:
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Accessed 9/9/2021.
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Comment: A commenter stated that the Delta variant of COVID-19, and
the potential for other variants, has undermined the knowledge and
experience gained by LTCHs earlier in the pandemic. Commenters stated a
continued delay would provide LTCHs the necessary capacity to
accommodate additional surges.
Response: We understand the conditions under which LTCHs are
working to address the number of new COVID-19 cases resulting from the
COVID-19 Delta variant. We disagree with the commenter, however, that
the knowledge and experience LTCHs have gained since the beginning of
the PHE has been undermined by the Delta variant. The Delta variant is
a mutation of the original SARS-CoV-2 strain, rather than a novel virus
as COVID-19 was when it emerged in January of 2020. While the CDC has
described Delta as more transmissible than the Alpha COVID-19
virus,\199\ many of the symptoms are similar.\200\ The methods of
reducing transmission of the Delta variant are also similar, that is
indoor masking, social distancing, and vaccination.\201\ Currently,
there are multiple treatments202 203 for COVID-19, and
vaccines that are either authorized through FDA's Emergency Use
Authorization 204 205 or have approval from FDA.\206\
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\199\ Delta Variant: What We Know about the Science. Available
at: https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html. Accessed 9/1/2021.
\200\ What Are the Symptoms of the COVID-19 Delta Variant?
Available at: https://www.emedicinehealth.com/what_are_the_symptoms_of_covid19_delta_variant/article_em.htm.
Accessed 9/1/2021.
\201\ 5 Things to Know About the Delta Variant. Available at:
https://www.yalemedicine.org/news/5-things-to-know-delta-variant-covid. Accessed 9/1/2021.
\202\ National Institutes of Health COVID-19 Treatment
Guidelines. Available at: https://www.covid19treatmentguidelines.nih.gov/. Accessed 9/9/2021.
\203\ FDA Approves First Treatment for COVID-19. October 22,
2020. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19. Accessed 9/9/
2021.
\204\ U.S. Food and Drug Administration (2021). Janssen Biotech,
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at
https://www.fda.gov/media/146303/download. Accessed 9/9/2021.
\205\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc.
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download. Accessed 9/9/2021.
\206\ FDA Approves First COVID-19 Vaccine [verbar] FDA. Accessed
9/03/21. The Pfizer-BioNTech vaccine also continues to be available
under EUA. U.S. Food and Drug Administration (2021). Comirnaty and
Pfizer-BioNTech COVID-19 Vaccine. Accessed 9/28/2021.
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Comment: Several commenters stated implementing the LCDS V5.0 would
divert critical patient care resources at a time when LTCHs are
struggling to keep up with current documentation requirements. They
raised concerns that having to train nursing staff to collect and
report these data would divert their attention away from direct patient
care.
Response: As described in section IX.B.2. of this final rule, we
have granted LTCH providers several waivers related to documentation in
order to ease burden during the PHE, and many of these are still in
effect. We are very mindful of burden that may occur from the
collection and reporting of data. Both the TOH Information to the
Patient--PAC measure and TOH Information to the Provider--PAC measure
are comprised of one item, and further, the activities associated with
the measure align with existing requirements related to transferring
information at the time of discharge to safeguard patients (84 FR 51882
and Sec. 482.43). Additionally, TEP feedback and pilot testing of the
items did not find the burden of reporting to be significant.\207\
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\207\ Transfer of Health Information TEP Meeting 4--June 2018.
Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meeting-4-June2018.pdf.
Accessed 9/9/2021.
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The new Standardized Patient Assessment Data Element items in the
LCDS V5.0 are also reflective of patient characteristic that providers
are likely already gathering in order to meet hospital conditions of
participation, such as patient's preferred language, race, ethnicity,
hearing, vision, health literacy, pain, high-risk drug classes and
cognitive function.
We also understand provider's concerns with developing training
materials for the TOH Information to the Patient--PAC measure and TOH
Information to the Provider--PAC measure items and the Standardized
Patient Assessment Data Elements. We plan to provide multiple training
resources and opportunities for LTCHs
[[Page 62390]]
to take advantage of, reducing the burden to LTCHs in creating their
own training resources. These training resources may include online
learning modules, tip sheets, questions and answers documents, and/or
recorded webinars and videos, and would be available to LTCHs in early
2022, allowing LTCHs several months to ensure their staff take
advantage of the learning opportunities. Having the materials online
and on-demand would also eliminate the need for large group gatherings,
a concern raised by some commenters. The LTCH QRP Helpdesk would also
be available for providers to submit their follow up questions by
email, further enhancing the educational resources.
Comment: We received comment stating that implementing the LCDS
V5.0 would require additional staffing, specifically nursing staff, at
a time when there is a pandemic-induced nursing staff shortage, which
in some areas is so critical that LTCH beds have been reduced.
Response: We interpret the commenter's concern regarding the
nursing shortage with the COVID-19 pandemic. According to the Centers
for Disease Control and Prevention's (CDC) COVID Data Tracker Weekly
review on October 1, 2021,\208\ the current 7-day moving average of
daily cases has decreased 13.3% compared to the previous 7-day moving
average. Additionally, COVID-19 cases have been steadily declining
since January 2021. Despite an uptick in weekly reported cases in
September, the height of new cases at that time was still 36% less than
the numbers reported in January 2021.\209\ According to the CDC's
forecast modeling, new cases are estimated to continue to decline
another 30% in the next four weeks. The impacts of the COVID-19 PHE on
the healthcare system, including staffing shortages, make it especially
important now to monitor quality of care.\210\ Still, we are mindful of
burden that may occur from the collection and reporting of our
measures. We emphasize, however, that that TOH Information Provider--
PAC and TOH Information Patient--PAC measures consist of one item each,
and further, the activities associated with the measures align with the
existing requirements related to transferring information at the time
of discharge to safeguard patients. Additionally, as stated in the FY
2020 IPPS/LTCH PPS Final Rule (84 FR 42535 through 42588), we convened
a Technical Expert Panel (TEP) \211\ and conducted a pilot test.\212\
Both the TEP feedback and the pilot participants found the burden of
reporting not to be significant.
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\208\ https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
\209\ Centers for Disease Control and Prevention. COVID-19
Forecasts: Cases. Available at: https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/forecasts-cases.html. Accessed
September 27, 2021.
\210\ Nursing and Patient Safety. Agency for Healthcare Research
and Quality. April 21, 2021. Available at: https://psnet.ahrq.gov/primer/nursing-and-patient-safety. Accessed 10/4/2021.
\211\ Transfer of Health Information TEP Meeting 4--June 2018.
Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-TEP-Meeting-4-June2018.pdf.
Accessed 9/1/2021.
\212\ Transfer of Health Information 2018 Pilot Test Summary
Report. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Transfer-of-Health-Information-Pilot-Test-Summary-Report_Final_Feb2018.pdf. Accessed 9/1/2021.
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We have strived to balance the scope and level of detail of the
data elements against the potential burden placed on LTCHs. We plan to
provide multiple training resources and opportunities for LTCHs to take
advantage of, which will reduce the burden to LTCHs. We plan to make
these training resources available to LTCHs in early 2022.
Comment: Several commenters pointed out the lack of Information
Systems (IT) personnel as a barrier to being able to implement the LCDS
V5.0 on October 1, 2022. They state that implementing the LCDS V5.0
would require new flowsheets, interfaces, and reports to inform the new
version of the assessment instrument, and they are limited in their
resources. They state that IT systems and personnel had to quickly
pivot to developing virtual platforms for care during the PHE, and/or
develop platforms and reports to implement mandatory and time-sensitive
COVID-19-related tracking requirements. A commenter noted that there
are also 2020 ``maintenance releases'' that have been delayed due to
the PHE and staffing shortages. As a result, these commenters do not
believe they have the operational resources to dedicate to the
investment of retooling their electronic health record for the LCDS
V5.0.
Response: While we acknowledge there will be some updates required
of IT vendors and systems, we believe a significant portion of the work
has already been completed. For example, we posted a change table in
November 2019 illustrating the changes that would occur to the LCDS
with the transition from the LCDS V4.0 to V5.0.\213\ In March 2020, we
posted the LCDS V5.0 Draft Technical Data Submission
Specifications.\214\ The LCDS V5.0 was not postponed due to the PHE
until June 17, 2020, fewer than 4 months before it was to be
implemented October 1, 2020. Therefore, we believe that most LTCHs
would have already made the necessary enhancements to their electronic
medical records and flowsheets in preparation for the transition. We
plan to provide the final draft specifications and release that to
providers and vendors in late 2021 or when technically feasible, which
would give providers just under 1 year to build their necessary IT
programs.
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\213\ File available here: https://www.cms.gov/files/zip/ltch-care-data-set-v50-effective-october-1-2020-zip.zip and on the LTCH
LCDS and LTCH QRP Manual webpage in the Downloads section at:
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/LTCH-Quality-Reporting/LTCH-CARE-Data-Set-and-LTCH-QRP-Manual.
\214\ File available here: https://www.cms.gov/files/zip/ltch-data-specs-v4000-draft-03-05-2020zip.zip and on the LTCH QRP
Technical Information webpage at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/LTCH-Quality-Reporting/LTCH-Technical-Information.
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Comment: A commenter stated they believe the benefit to CMS of
having this information to study is significantly outweighed by the
burden imposed on LTCHs.
Response: We would like to clarify that CMS proposed to begin
collecting the TOH Information to the Patient--PAC measure, the TOH
Information to the Patient-Provider measure, and the Standardized
Patient Assessment Data Elements to support our responsibility to
monitor and ensure quality of care for patients. Additionally, this
information will provide actionable data on which LTCHs can improve
health care outcomes.
Final Decision: After careful consideration of the comments
received, we are finalizing our proposal that LTCHs begin collecting
the TOH Information to Provider-PAC measure, the TOH Information to the
Patient-PAC measure, and 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.
X. COVID-19 Reporting Requirements for Long Term Care Facilities
A. Background
The United States is responding to the COVID-19 Public Health
Emergency (PHE) caused by the coronavirus which has been detected in
more than 190 countries internationally, and all 50
[[Page 62391]]
States and the District of Columbia. In an effort to respond to the
COVID-19 PHE and protect the health and safety of LTC facility
residents, CMS published three interim final rules with comment period
(IFCs) directly affecting LTC facilities. The May 8, 2020 IFC titled,
``Medicare and Medicaid Programs, Basic Health Program, and Exchanges;
Additional Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency and Delay of Certain Reporting Requirements for
the Skilled Nursing Facility Quality Reporting Program'' (85 FR 27550)
revised the infection prevention and control requirements for LTC
facilities to more effectively respond to the specific challenges posed
by the COVID-19 pandemic. Specifically, this IFC added provisions to
require facilities to electronically report information related to
confirmed or suspected COVID-19 cases in a standardized format and
frequency specified by the Secretary and required facilities to inform
residents and their representatives of confirmed or suspected COVID-19
cases in the facility among residents and staff.
The September 2, 2020 IFC, entitled ``Medicare and Medicaid
Programs, Clinical Laboratory Improvement Amendments (CLIA), and
Patient Protection and Affordable Care Act, Additional Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency'' (85 FR 54820, 54873) set out provisions regarding testing
for COVID-19 in long-term care facilities, including documentation
requirements and protocols specifying actions to be taken if a resident
or staff member tests positive. The May 13, 2021 IFC, titled ``Medicare
and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care
(LTC) Facilities and Intermediate Care Facilities for Individuals with
Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff''
(86 FR 26306) revised the infection control requirements that LTC
facilities and intermediate care facilities for individuals with
intellectual disabilities (ICFs-IID) must meet to participate in the
Medicare and Medicaid programs. This IFC aimed to reduce the spread of
SARS-CoV-2 infections, the virus that causes COVID-19 by requiring
education about COVID-19 vaccines for LTC facility residents, ICF-IID
clients, and staff serving both populations, and by requiring that such
vaccines, when available, be offered to all residents, clients, and
staff. It also required LTC facilities to report COVID-19 vaccination
status of residents and staff to the Centers for Disease Control and
Prevention (CDC). Additional information and data regarding SARS-CoV-2,
and populations at greatest risk were presented in these IFCs (85 FR
27550 and 86 FR 26306).
This final rule focuses on the LTC facility COVID-related reporting
requirements established in these three IFCs and codifies these
requirements in order to extend them beyond the PHE. While COVID-19
cases for both staff and residents had been consistently declining from
April to July 2021, there has been a recent increase in confirmed cases
for staff and residents of LTC facilities.\215\ In addition, the Delta
variant is currently the predominant variant of the virus in the United
States. It is more infectious and has led to increased transmissibility
when compared to other variants, even in some vaccinated individuals.
Specifically, the Delta variant is more than 2x contagious than
previous variants. Preliminary data also suggest that the Delta variant
may cause more severe illness than previous variants in unvaccinated
people. Available data continue to suggest that breakthrough infections
are relatively rare, and the majority of new cases are attributable to
unvaccinated persons. The greatest risk of transmission is among
unvaccinated people who are more likely to become infected, and
therefore transmit the virus.\216\ Furthermore, while resident
vaccination rates are high in LTC facilities, standing at about 84
percent, it is not reasonable to anticipate complete vaccination
coverage, leaving all facilities at risk for a COVID-19 outbreak after
the official PHE declaration has ended. It is also important to note
that only 64 percent of current nationwide LTC facility staff have been
vaccinated.\217\ The nature of LTC facilities make outbreaks of COVID-
19 difficult to control, especially as many staff and potentially
residents may be asymptomatic. Asymptomatic people with SARS-CoV-2 may
move in and out of the LTC facility and the community, putting
residents and staff at risk of infection. The CDC is continuing to
assess data on whether fully vaccinated individuals with asymptomatic
breakthrough infections can transmit the virus.\218\ Routine testing of
LTC residents and staff, along with visitation restrictions, personal
protective equipment (PPE) usage, social distancing, and vaccination
for residents and staff are the best defense against COVID-19.
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\215\ Data.CMS.gov, COVID-19 Nursing Home Data, https://data.cms.gov/covid-19/covid-19-nursing-home-data.
\216\ Centers for Disease Control and Prevention, Delta Variant:
What We Know About the Science https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html.
\217\ Data.CMS.gov, COVID-19 Nursing Home Data, https://data.cms.gov/covid-19/covid-19-nursing-home-data.
\218\ Centers for Disease Control and Prevention, Delta Variant:
What We Know About the Science https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11512:covid%20delta:sem.ga:p:RG:GM:gen:PTN:FY21.
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The rate of staff vaccination, coupled with the continued threat of
numerous variants, including the highly transmissible Delta variant,
the congregate living nature of LTC facilities that make them more
susceptible to COVID-19 outbreaks, and breakthrough cases, creates an
ongoing risk of outbreaks, with significant risks of morbidity and
mortality, in this higher risk population. This final rule maintains
the current COVID-19 reporting requirements while modifying the
reporting frequency of these requirements to no more than weekly, which
may be reduced at the discretion of the Secretary, and adds a sunset
date of December 31, 2024 for most of the reporting requirements, in
order to ensure patient safety and health while informing future
pandemic and emergency response.
B. Statutory Authority and Regulatory Background
Under sections 1866 and 1902 of the Act, providers of services
seeking to participate in the Medicare or Medicaid program, or both,
must enter into an agreement with the Secretary or the State Medicaid
agency, as appropriate. Long-term care (LTC) facilities seeking to be
Medicare and Medicaid providers of services must be certified as
meeting Federal participation requirements. LTC facilities include SNFs
for Medicare and NFs for Medicaid. The Federal participation
requirements for SNFs, NFs, and dually certified facilities, are set
forth in sections 1819 and 1919 of the Act and codified in the
implementing regulations at 42 CFR part 483, subpart B.
Sections 1819(d)(3) and 1919(d)(3) of the Act explicitly require
that LTC facilities develop and maintain an infection control program
that is designed, constructed, equipped, and maintained in a manner to
protect the health and safety of residents, personnel, and the general
public. In addition, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the
Act explicitly authorize the Secretary to issue any regulations he
deems necessary to protect the health and safety of
[[Page 62392]]
residents. Infection prevention and control is a primary goal of
initiatives taking place in LTC facilities during the COVID-19 PHE.
Under the explicit instructions of Congress, existing regulations at
Sec. 483.80 require facilities to, among other things, establish and
maintain an infection prevention and control program (IPCP) designed to
provide a safe, sanitary, and comfortable environment and to help
prevent the development and transmission of communicable diseases and
infections.
C. Summary of the Provisions and Responses to Public Comments
In response to the three IFCs that were published on May 8, 2020,
September 2, 2020, and May 13, 2021, we received 537 total comments.
Commenters included individuals, health care professionals and
corporations, national associations and coalitions, patient advocacy
organizations, and individual facilities that will be impacted by the
rule.
In this final rule, we are finalizing provisions from two of the
three IFCs that made amendments to Sec. 483.80. We provide a summary
of our proposed provisions, a summary of the public comments received
and our responses to them, and the policies we are finalizing for LTC
facilities. We have organized our proposed provisions and responses to
the comments as follows: COVID-19 Reporting and Vaccine Reporting.
Comments related to the collection of information requirements and
impact analysis sections are addressed in sections XI and XII,
``Collection of Information Requirements'' and ``Regulatory Impact
Analysis'' of this final rule.
1. Requirement for Facilities To Report Nursing Home Residents and
Staff Infections, Potential Infections, and Deaths Related to COVID-19
(Sec. 483.80(g)(1) Through (3))
In the IFC, ``Medicare and Medicaid Programs, Basic Health Program,
and Exchanges; Additional Policy and Regulatory Revisions in Response
to the COVID-19 Public Health Emergency and Delay of Certain Reporting
Requirements for the Skilled Nursing Facility Quality Reporting
Program'' (85 FR 27550), we finalized a requirement at Sec. 483.80
(g)(1), that LTC facilities electronically report information about
COVID-19 in a standardized format specified by the secretary. This
report must include suspected and confirmed COVID-19 infections among
residents and staff, including residents previously treated for COVID-
19; total deaths and COVID-19 deaths among residents and staff;
personal protective equipment and hand hygiene supplies in the
facility; ventilator capacity and supplies in the facility; resident
beds and census; access to COVID-9 testing while the resident is in the
facility; and staffing shortages.
In addition, Sec. 483.80(g)(2) requires that the information
specified in Sec. 483.80(g)(1) be provided at a frequency specified by
the Secretary, but no less than weekly to the CDC's National Healthcare
Safety Network (NHSN). Finally, Sec. 483.80(g)(3) requires that
residents, their representatives, and their families be informed of the
occurrence of either a single or confirmed infection of COVID-19, or
three or more residents or staff with new-onset of respiratory symptoms
occurring within 72 hours of each other. This information must be
reported to the residents, their representatives, and their families by
5:00 PM the next calendar day.
In response to the May 8, 2020 IFC, we received 297 public
comments. While a significant number of commenters indicated that they
supported increased reporting requirements, the majority of the
comments expressed concerns about the burden of the reporting
requirements.
Comment: A significant number of commenters indicated that the
reporting requirements were too burdensome, time consuming,
duplicative, and create a heightened sense of alarm.
Response: We understand the burden concerns expressed by
commenters. However, due to the unpredictable nature of the virus and
the new variants that are arising, we believe that it is vital that
this information be collected and recorded. Retaining the data
reporting requirements after the end of the PHE is an important element
of maintaining effective surveillance of this novel virus. While COVID-
19 cases for both staff and residents were consistently declining for
several weeks, there has been an increase in confirmed cases for staff
and residents of LTC facilities. Specifically, national case rates have
continued to climb precipitously, reaching levels not seen since early
February 2021. As of October 1, 2021, the current 7-day moving average
of daily new cases was 106,395. As of September 25, 2021, the overall
rate of COVID-19 hospitalizations per 100,000 was 6.4
hospitalizations.\219\ Collectively, this information highlights the
gravity of the delta variant.
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\219\ COVID-NET, Laboratory-Confirmed COVID-19-Associated
Hospitalizations https://gis.cdc.gov/grasp/covidnet/covid19_3.html.
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The rate of staff vaccinations, coupled with the presence of
multiple variants, specifically the highly contagious Delta variant,
and breakthrough infections, creates an ongoing risk of outbreaks, with
significant risks of morbidity and mortality, in this higher risk
population. Timely and actionable surveillance will enable CMS to
continue to respond to facilities in need of additional technical
support and oversight, should they experience new COVID-19 infections.
In addition, agencies across HHS have released data and guidance
that should have addressed and alleviated some of the confusion that
commenters are referring to. As such, we will be maintaining the
current reporting requirements, which require LTC facilities to report
weekly, unless the Secretary specifies a lesser frequency, and the
potential to modify the number of data elements reported in the future,
contingent upon the state of the pandemic. In an effort to further
address concerns regarding burden, we are also finalizing a sunset date
of December 31, 2024 for the reporting requirements, with the exception
of the staff and resident vaccination reporting requirements in Sec.
[thinsp]483.80(g)(1)(viii). We believe that the need to collect data
will likely extend past the end of the PHE. We therefore are granting
ourselves and other government authorities the continued ability to
monitor LTC facilities, given that this population has been most
vulnerable to the virus. This provision will automatically expire on
December 31, 2024 unless it is determined that further regulations must
be established.
Comment: Several commenters questioned the need to report COVID
related deaths for individuals with multiple comorbidities, as many LTC
residents have pre-existing and chronic conditions, and they believe
that COVID was not the primary or sole cause of death.
Response: Many individuals that succumb to COVID-19 have multiple
co-morbidities, none of which negate a person's COVID-19 infection
status. COVID-19 related deaths need to be reported to provide CMS with
information that enables us to protect these vulnerable populations and
ensure that the appropriate care is being provided. Therefore, we are
retaining the requirement that facilities must report nursing home
resident and staff infections, potential infections, and deaths related
to COVID-19.
In an effort to support surveillance of COVID-19 cases, we are
maintaining the requirements to establish explicit reporting
requirements for confirmed or suspected cases with the possibility for
reduced frequency of reporting and minimizing the number of required
data
[[Page 62393]]
elements in the future at the discretion of the Secretary.
Specifically, we are finalizing our requirements by maintaining the
provision at Sec. [thinsp]483.80(g)(1)(i) through (ix), to require
facilities to electronically report information about COVID-19 in a
standardized format specified by the Secretary. The report includes,
but is not limited to, information on: Suspected and confirmed COVID-19
infections among residents and staff, including residents previously
treated for COVID-19; total deaths and COVID-19 deaths among residents
and staff; personal protective equipment and hand hygiene supplies in
the facility; ventilator capacity and supplies available in the
facility; resident beds and census; access to COVID-19 testing while
the resident is in the facility; staffing shortages; and other
information specified by the Secretary. In the future, the number of
data elements required to be reported may be reduced to allow for
greater flexibility and mitigate burden concerns. This information will
be used to monitor trends in infection rates, and inform future public
health and emergency preparedness policies.
Comment: A commenter stated that the rationale for additional
reporting to Federal authorities is unclear, since LTC facilities must
already report to State and local authorities and that a universal
reporting system should be used instead.
Response: Federal reporting requirements are used by State and
local authorities to inform their operations and pandemic response for
their particular population. We understand the burden concerns
expressed by commenters and have therefore revised the frequency of
reporting information specified in paragraph (g)(1) to weekly, unless
the Secretary specifies a lesser frequency, and a reduced number of
data elements in the future, at the discretion of the Secretary, when
the COVID-19 virus is less prevalent and we may no longer need all of
this data as frequently. Due to the variation in mandates across States
and localities, we will continue to require surveillance efforts at the
Federal level and maintain current reporting requirements.
In addition, at Sec. [thinsp]483.80(g)(2), we are revising the
current requirements to require that LTC facilities provide the
information noted previously weekly, unless the Secretary specifies a
lesser frequency, to the Center for Disease Control and Prevention's
(CDC) National Healthcare Safety Network (NHSN) with the possibility
for reduced frequency of reporting in the future, contingent on the
state of the PHE. Furthermore, we note that the information reported
will be shared with us and we will retain and publicly report this
information to support protecting the health and safety of residents,
in accordance with sections 1819(d)(4)(B) and 1919(d)(4) of the Act, as
well as facility personnel, and the general public. These requirements
will support our efforts to proactively and transparently inform
interested parties and ensure that the most complete information on
COVID-19 cases is available. The existing reporting requirements at
Sec. 483.80(g)(1) and (2) do not relieve LTC facilities of the
obligation to continue to comply with Sec. 483.80(a)(2)(ii), which
requires facilities to report possible incidents of communicable
disease and infections. This includes complying with State and local
reporting requirements for COVID-19.
Comment: Many commenters indicated that the reporting requirements
are not stringent or detailed enough, resulting from lack of oversight
and the vague definitions/terminology set out in the IFCs. A
significant portion of commenters requested further clarification and
more detailed regulations to ensure that programs achieved better
quality and lower costs.
Commenters also recommended additional reporting requirements
including but not limited to retroactive reporting and the collection
of additional demographic information (race, ethnicity, sex, age,
disability status, primary language, sexual orientation, gender
identity, socio-economic status, and location (urban/rural)). The
commenters noted that retroactive reporting dating back to January 1,
2020, is necessary in order to gain a better understanding of the
trajectory of SARS-CoV-2 and the rapidly evolving situation. A few
commenters also expressed their desire for disability status to be
collected as well, as these individuals are often predisposed to
disease and are more likely to experience medical complications and
succumb to the virus.
The majority of commenters also recommended additional reporting
requirements regarding the number of staff and residents who were
hospitalized and who recovered from COVID-19. They stated that
additional reporting requirements related to testing should include the
number of residents and staff who have been tested, the percent of
residents and staff who have been tested, the frequency of resident and
staff testing, and the number of tests available.
Response: The reporting requirements were written in a manner that
would allow for maximum flexibility by covering a broad array of
services and entities. While we agree that additional data, including
demographic information, could be useful to inform the pandemic
response, especially since underserved populations including racial and
ethnic minorities have been disproportionately impacted by COVID-19, we
also understand that additional requirements could be more burdensome
for providers that are caring for residents during the pandemic at this
time. However, we are committed to advancing health equity and reducing
disparities for those in underserved populations that have been
disproportionately impacted by COVID-19 and we believe that these data
reporting requirements are an essential first steps in helping us
better understand the impacts of COVID-19 on underserved populations
that reside in LTC facilities. Information gained from this reported
data will be assessed and used to determine if additional policy
changes, especially those affecting underserved populations, should be
made in the future. Additionally, the NHSN system already collects this
type of information and, therefore, we are not adding additional
categories in order to avoid duplicative efforts and further confusion.
In an effort to mitigate potential concern about the burdensome nature
of the requirements, we will not be adding additional reporting
requirements and data elements at this time, but we have modified our
regulations to include the flexibility to change the data elements that
are required to be reported to NHSN in the future, as appropriate.
Comment: Many commenters noted that the current reporting
requirements do not accomplish the goal of ensuring that residents are
informed participants in the care that they receive.
Response: We disagree with the commenters. The collection of this
data allows for residents and their caregivers to be informed
participants in their care, as it allows them to understand the current
state of the environment that they reside in. Resident health and
safety are of the utmost importance, and therefore, we are continuing
all of our current reporting requirements.
Specifically, at Sec. [thinsp]483.80(g)(3), we are maintaining the
provision to require facilities to inform residents, their
representatives, and families of those residing in facilities of
confirmed or suspected COVID-19 cases in the facility among residents
and staff. This reporting requirement supports the overall health and
safety of residents by ensuring they are informed participants in the
care that they receive as well as providing assurances of the
mitigating
[[Page 62394]]
steps the facility is taking to prevent and control the spread of
COVID-19. Facilities must inform residents, their representatives, and
families by 5 p.m. the next calendar day following the occurrence of
either: A single confirmed infection of COVID-19; or three or more
residents or staff with new-onset of respiratory symptoms that occur
within 72 hours of each other. Also, cumulative updates to residents,
their representatives, and families must be provided at least weekly by
5 p.m. the next calendar day following the subsequent occurrence of
either: (1) Each time a confirmed infection of COVID-19 is identified;
or (2) whenever three or more residents or staff with new onset of
respiratory symptoms occur within 72 hours of each other. This
information must be reported in accordance with existing privacy
regulations and statute and must not include Personally Identifiable
Information (PII). Facilities must include information on mitigating
actions implemented to prevent or reduce the risk of transmission,
including if normal operations in the nursing home will be altered such
as restrictions or limitations to visitation or group activities. For
purposes of this reporting requirement and to mitigate the concerns
regarding burden that have been expressed in public comments,
facilities are not expected to make individual telephone calls.
Instead, facilities can utilize communication mechanisms that make this
information easily available to all residents, their representatives,
and families, such as paper notification, listservs, website postings,
or recorded telephone messages.
These reporting requirements, along with public reporting of the
data, support our responsibility to protect and ensure the health and
safety of residents by enforcing the standards required to help each
resident attain or maintain their highest level of well-being. In
addition, sections 1819(d)(3)(B) and 1919(d)(3) of the Act requires
that a facility must establish an infection control program that is
designed, constructed, equipped, and maintained in a manner to protect
the health and safety of residents, personnel, and the general public.
We believe that the reporting requirements comply with these statutory
requirements. We also note that they are necessary for us to monitor
whether individual nursing homes are appropriately tracking,
responding, and mitigating the spread and impact of COVID-19 on our
most vulnerable citizens, personnel who care for them, and the general
public. The information provided may be used to inform residents,
families, and communities of the status of COVID-19 infections in their
area. We believe that this action strengthens our response to the PHE
for the COVID-19 pandemic and reaffirms our commitment to transparency
and protecting the health and safety of nursing home residents.
2. COVID-19 Vaccine Reporting for Residents and Staff (Sec.
[thinsp]483.80(g)(1)(viii))
In the May 2021 IFC, ``Medicare and Medicaid Programs; COVID-19
Vaccine Requirements for Long-Term Care (LTC) Facilities and
Intermediate Care Facilities for Individuals with Intellectual
Disabilities (ICFs-IID) Residents, Clients, and Staff'', we finalized a
requirement, at Sec. [thinsp]483.80(g)(1)(viii), that LTC facilities
report on the COVID-19 vaccine status of residents and staff, including
total numbers of residents and staff, numbers of residents and staff
vaccinated, numbers of each dose of COVID-19 vaccine received, and
COVID-19 vaccination adverse events. We are also finalizing the
requirement at Sec. [thinsp]483.80(g)(1)(ix) to require the reporting
of therapeutics administered to residents for treatment of COVID-19. We
received 71 comments in response to this IFC, with no comments
discussing the requirement to report information about therapeutics
administered to residents for treatment of COVID-19. A significant
number of commenters indicated that they supported increased reporting
requirements, however, the majority of the comments expressed concerns
about the burdensome nature of the requirements.
Comment: Several commenters supported our staff and resident
vaccination reporting requirements and cited statistics about the
higher rate of contracting COVID-19 and succumbing to the virus
compared to the general population. Additionally, they note, continued
collection of data and surveillance will allow CDC and other Federal
agencies to identify facilities that need additional support. This will
also enable current and prospective residents and families to make
informed decisions regarding their options for care.
Response: We thank commenters for their support and their ability
to recognize the gravity of the situation. Due to the evolving nature
of the virus and the continued threat of the delta and other new
variants, it is vital that surveillance be maintained. On August 18,
CMS announced the development of an emergency regulation requiring
staff vaccinations within the nation's more than 15,000 Medicare and
Medicaid-participating nursing homes. Subsequently, on September 9, CMS
announced the expansion of the August 18 announcement requiring staff
vaccinations in nursing homes to add additional Medicare and Medicaid-
certified health care providers and suppliers certified by CMS,
including, but not limited to, hospitals, dialysis facilities,
ambulatory surgical centers, and home health agencies. We believe
maintaining these vaccination reporting requirements aligns with the
President's recent announcements \220\ regarding staff vaccination.
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\220\ The White House, Remarks by President Biden on Fighting
the COVID-19 Pandemic https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/09/remarks-by-president-biden-on-fighting-the-covid-19-pandemic-3/.
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Comment: Most commenters indicated that this vaccine reporting
requirement is challenging to comply with due to staffing shortages,
difficulty hiring and retaining a qualified workforce, and paying
competitive wages. Many commenters expressed concern about the time it
takes to complete the reporting due to short staffing and the
requirement to report to multiple entities. Commenters also questioned
if this requirement is the best use of resources, and argue that this
time would be better utilized providing personal care. A few commenters
noted that smaller LTC facilities do not have the same kind of
infrastructure and resources that larger agencies and other
institutional providers have access to, and that this should be
considered when determining compliance and expectations of the rule.
The majority of commenters were concerned that these vaccine
reporting requirements were duplicative of other currently existing
requirements and systems used for reporting this data. Some of these
commenters noted that the requirements are duplicative of requirements
to report this data to State and local health departments.
Additionally, a few commenters were unclear on where to report
vaccination metrics and how to document compliance efforts. A commenter
expressed concern that this type of reporting is only beneficial for
data analysts, not the residents of the facility.
Commenters believed that reporting should be more user friendly and
less time consuming. Most commenters were in favor of using systems
that are already in place and that they use often (Minimum Data Set
[MDS], Payroll Based Journal [PBJ]) in order to improve these processes
and comply with the requirements. Commenters recommended creating an
item for
[[Page 62395]]
COVID-19 vaccinations in the MDS for residents and pulling data from
there. Multiple commenters also proposed adding an item on PBJ data
submissions for staff requirements. PBJ and MDS are already required,
the commenters stated, and they explained that it would take less time
to complete these reporting requirements through these platforms
instead of NHSN. Additionally, a small number of commenters shared some
privacy concerns and implications of tracking and documenting staff
vaccination status through NHSN.
Finally, a commenter indicated that they could use MDS to submit
this information as they do for pneumonia and influenza; this would
combine processes that are already in place. Another commenter also
suggested REDCap as an alternative, as it is used for the Federal
Partnership Vaccine Program.
Response: We acknowledge the burdensome nature of some of these
requirements and thank the staff for their hard work in complying with
these requirements while providing care to their residents. Since this
IFC was initially published, CMS and other agencies across HHS have
released additional guidance in an effort to address some of these
questions and concerns about how to comply to these requirements.
Additionally, CMS has standing calls with several key stakeholders in
an effort to address some of these questions and concerns. We recognize
that some facilities have stronger infrastructures and more resources
available to work with. However, while some of this reporting may seem
duplicative of other State and local reporting requirements, it has
been instrumental in developing a tailored pandemic response and allows
authorities to understand where most resources need to be directed.
Consistent vaccination reporting by LTC facilities via the NHSN
will help to identify LTC facilities that have potential issues with
vaccine confidence or slow uptake among either residents or staff or
both. The NHSN is the nation's most widely used health care-associated
infection (HAI) tracking system. It furnishes States, facilities,
regions, and the government with data regarding problem areas and
measures of progress. CDC and CMS use information from NHSN to support
COVID-19 vaccination programs by focusing on groups or locations that
would benefit from additional resources and strategies that promote
vaccine uptake. CMS surveyors and State agency surveyors will use the
vaccination data in conjunction with the reported data that includes
COVID-19 cases, resident deaths, staff shortages, PPE supplies and
testing. This combination of reported data is used by surveyors to
determine individual facilities that need to have focused infection
control surveys as well as technical assistance in expanding vaccine
delivery and uptake. Facilities having difficulty with vaccine
acceptance can be identified through examining trends in NHSN data; and
the Quality Improvement Organizations (QIOs), groups of health quality
experts, clinicians, and consumers organized to improve the quality of
care delivered to people with Medicare, can provide assistance to
increase vaccine acceptance. Specifically, QIOs may provide assistance
to LTC facilities by targeting small, low performing, and rural nursing
homes most in need of assistance, and those that have low COVID-19
vaccination rates; disseminating accurate information related to access
to COVID-19 vaccines to facilities; educating residents and staff on
the benefits of COVID-19 vaccination; understanding nursing home
leadership perspectives and assist them in developing a plan to
increase COVID-19 vaccination rates among residents and staff; and
assisting providers with reporting vaccinations accurately.
We believe direct submission of data by LTC facilities through NHSN
will show actions and trends that can be addressed more efficiently on
a national level. All State health departments and many local health
departments already have direct access through NHSN to LTC facilities'
COVID-19 data and are using the data for their own local response
efforts. Thus, reporting in NHSN will, in many cases, serve the needs
of State and local health departments.
Therefore, we are modifying the requirements at Sec.
[thinsp]483.80(g)(1)(viii) to require that LTC facilities report to
NHSN, on a weekly basis, unless the Secretary specifies a lesser
frequency, the COVID-19 vaccination status and related data elements of
all residents and staff. The data to be reported each week will be
cumulative, that is, data on all residents and staff, including total
numbers and those who have received the vaccine, as well as additional
data elements. In this way, the vaccination status of every LTC
facility will be known on a weekly basis. Data on vaccine uptake will
be important to understanding the impact of vaccination on SARS-CoV-2
infections and transmission in nursing homes. This understanding, in
turn, will help CDC make changes to guidance to better protect
residents and staff in LTC facilities. In addition, LTC facilities must
also report any COVID-19 therapeutics administered to residents. CDC
has currently defined ``therapeutics'' for the purposes of the NHSN as
a ``treatment, therapy, or drug'' and stated that monoclonal antibodies
are examples of anti-SARS-CoV-2 antibody-based therapeutics used to
help the immune system recognize and respond more effectively to the
SARS-CoV-2 virus.
Our intent in mandating reporting of COVID-19 vaccines and
therapeutics to NHSN is in part to monitor broader community vaccine
uptake, but also to allow CDC to identify and alert CMS to facilities
that may need additional support in regards to vaccine education and
administration. The information reported to CDC in accordance with
Sec. [thinsp]483.80(g) will be shared with CMS and we will retain and
publicly report this information to support protecting the health and
safety of residents, staff, and the general public, in accordance with
sections 1819(d)(3)(B) and 1919(d)(3) of the Act.
Comment: A significant proportion of commenters recommended that
CMS expand these vaccination reporting requirements to other facilities
where Medicare beneficiaries receive care ([psychiatric] residential
treatment facilities, psychiatric hospitals, adult foster care homes,
group homes, and assisted living facilities) as these communities are
at the highest risk for infection and severe illness. Another commenter
stated that this requirement should also be expanded to include
prisons, homeless shelters, forensic hospitals, supervised apartments,
and inpatient hospice facilities. Several commenters also emphasized
the importance of this due to the emergence of new variants and
continued mitigation efforts.
Some commenters highlighted the disproportionate impact that COVID-
19 has had on minority groups and individuals with disabilities.
Because of this, commenters recommended that CMS arrange and collect
vaccination reporting data by race and ethnicity. They stated that the
data should be de-aggregated to examine the disparate outcomes for
individuals based on sex, age, race, and ethnicity. Another commenter
believes that in addition to data on race and ethnicity, data on sexual
orientation, gender identity, preferred language, urban/rural
environment, and service setting should be collected. The commenters
stated that for people with intellectual and developmental
disabilities, as well as other disability groups, the pandemic has
revealed the need for public health
[[Page 62396]]
surveillance systems to include disability status as a basic
demographic characteristic.
Response: We agree that additional data collection could be useful
in informing emergency preparedness and future pandemic response and we
reaffirm our commitment to addressing disparities in healthcare that
have disproportionately affected underserved populations. However, in
an effort to mitigate some of the burden concerns expressed by
commenters, we will not be adding additional data elements or reporting
requirements. Instead, we will maintain the current reporting
requirements for the reporting of staff and resident vaccinations. The
May 2021 IFC sought information regarding the potential application of
these requirements in other congregate living settings and suggested
ICFs-IID report vaccine administration. However, in light of the
commenters overall concerns regarding the burden of these reporting
requirements, we do not believe that it is appropriate to mandate these
requirements for other congregate living settings at this time.
Additionally, CMS does not have the authority to extend these reporting
requirements to some of the settings that commenters discuss, including
prisons, assisted living facilities, supervised apartments, or homeless
shelters. We appreciate this feedback and will consider it for future
rulemaking.
We believe that all LTC facility residents and the staff who care
for them, should be provided with ongoing access to vaccination against
COVID-19. The accountable entities responsible for the care of
residents and clients of LTC facilities must proactively pursue access
to COVID-19 vaccination due to a unique set of challenges that
generally prevent these residents and clients from independently
accessing the vaccine. These challenges create potential disparities in
vaccine access for those residing in LTC facilities. It is CMS's
understanding that very few individuals who are residents of LTC
facilities are likely able to independently schedule or travel to
public offsite vaccination opportunities. People reside in LTC
facilities because they need ongoing support for medical, cognitive,
behavioral, and/or functional reasons. Because of these issues, they
may be less capable of self-care, including arranging for preventive
health care. Independent scheduling and traveling off-site may be
especially challenging for people with low health literacy,
intellectual and developmental disabilities, dementia including
Alzheimer's disease, visual or hearing impairments, or severe physical
disability. To support national efforts to control the spread of COVID-
19, we are finalizing the LTC facility infection control regulations
related to reporting COVID-19 data at Sec. [thinsp]483.80(g)(1)(viii)
so that they will continue in effect. We have not finalized a sunset
date for these requirements in order to allow for continued monitoring
and surveillance of vaccine delivery and uptake.
Comment: Several commenters shared their stance on vaccination and
indicated that vaccines should not be required and that this should be
a decision between an individual and their provider. A commenter
expressed feeling being ``discriminated'' against because of the
commenter's decision to not receive the COVID vaccination.
Response: The IFCs did not finalize a vaccination mandate for LTC
staff or residents; therefore, these comments outside the scope of this
rule. We are maintaining the requirement at Sec. 483.80(g)(1)(viii)
for the reporting of staff and resident vaccinations.
Final Decision: After consideration of the public comments we
received on the COVID-19 reporting requirements, we are finalizing the
requirements at Sec. 483.80(g)(1) through (3) with the following
modifications: (1) Reporting frequency of the information specified in
Sec. 483.80(g)(1) is modified to weekly, unless the Secretary
specifies a lesser frequency; (2) Reporting data elements are
unchanged, but may be reduced, contingent on the state of the pandemic
and at the discretion of the Secretary; and (3) with a sunset date of
December 31, 2024 for all reporting requirements, with the exclusion of
the requirements at Sec. [thinsp]483.80(g)(1)(viii).
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BILLING CODE C
XI. Collection of Information Requirements and Waiver of Proposed
Rulemaking
A. Statutory Requirement for Solicitation of Comments
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
In the CY 2022 HH PPS proposed rule, we solicited public comment on
each of these issues for the following sections of this document that
contain information collection requirements.
B. Collection of Information Requirements
1. HH QRP
In section IV.C. of the proposed rule, we proposed 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 data to CMS under the HH QRP. For 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 38.
[GRAPHIC] [TIFF OMITTED] TR09NO21.057
In section IV.C.4.a. of the final rule, we are finalizing our
proposal 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. Further, we are finalizing our proposal to remove OASIS item
M2016 used to calculate this measure. This item removal results in a
decrease in overall burden.
In sections IV.C.4.b. of this final rule, we are finalizing our
proposal to adopt the Home Health Within Stay Potentially Preventable
Hospitalization measure which is claims-based. We are replacing 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, their replacement or
removal does not impact our collection of information.
Therefore, the result of our final policies is 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 assumed that each
data element requires 0.3 minutes of clinician time to complete.
Therefore, we estimated 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 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 38 Individual providers
determine the staffing necessary.
Table 39 shows the total number of assessments submitted in CY 2020
and estimated costs at each time point.
[[Page 62399]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.058
Based on the data in Tables 38 and 39 for the 11,400 active
Medicare-certified HHAs, we estimated 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 as derived in the RIA section. This
corresponds to an estimated decrease in clinician burden associated
with the changes to the HH QRP of approximately 3.1 hours per HHA or
approximately 34,785 hours for all HHAs. This decrease in burden will
be accounted for in the information collection under OMB control number
0938-1279 (Expiration date: 12/31/2021).
In section IV.C. of this final rule, we are finalizing our proposal
to revise the 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.
We did not receive any comments on this proposal and therefore are
finalizing this provision without modification.
2. ICRs Regarding Revised Compliance Dates for Certain Reporting
Requirements
a. IRF QRP Requirements
In section VIII.A. of the proposed rule, we proposed to revise the
compliance date for certain reporting requirements adopted for the IRF
QRP. We believe that the burden associated with the IRF QRP proposed
provision is the time and effort associated with reporting data. As of
April 4, 2021, there are approximately 1,109 IRFs reporting IRF QRP
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 proposed provision would
not affect the information collection burden for the IRF QRP.
We did not receive any comments on this proposal and therefore are
finalizing this provision without modification.
b. LTCH QRP Requirements
In section VIII.B. of the proposed rule, we proposed 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 data. As of April 21,
2021, there are approximately 363 LTCHs reporting LTCH QRP 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
(Expiration date: 12/31/2022). Therefore, this proposal would not
affect the information collection burden for the LTCH QRP.
We did not receive any comments on this proposal and therefore are
finalizing this provision without modification.
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 the final rule, we revised Sec. 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 finalized Sec. 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
met the patient's needs. The home health aide would not need to be
present during this visit. We are also finalizing with modification
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 each home health aide while he or she is performing care for
each of their assigned patients. This semi-annual supervisory visit of
the aide performing care would replace the current every 60-day
requirement of direct supervision of the aide performing care. In
addition, we are finalizing Sec. 484.80(h)(3), which includes
retraining and competency evaluations related to both the skills
verified as deficient and any related skills. We believe that this
would not add any information collection burden and would 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 and approved under OMB control number: 0938-1299
(Expiration date: 06/30/2024). Therefore, we did not propose to seek
[[Page 62400]]
PRA approval for any information collection or recordkeeping activities
that may be conducted in connection with the proposed revisions to
Sec. 484.80(h), but we requested 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.
We did not receive comments on his section of the collection of
information proposed and therefore are finalizing this provision
without modification.
b. ICRs Related To Permitting Occupational Therapist To Complete the
Initial and Comprehensive Assessments for Home Health Agencies
In section IV.D. of the final rule, we are implementing Division
CC, section 115 of CAA 2021 by finalizing conforming regulations text
changes at Sec. 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 not initially on the home health plan of care. These
changes, which 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 finalized revisions to the requirements at Sec. 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 did not propose to seek PRA approval for any
information collection or recordkeeping activities that may be
conducted in connection with the proposed revisions to Sec.
484.55(a)(2) and (b)(3), but we requested 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.
We did not receive comments on his section of the collection of
information proposed and therefore are finalizing this provision
without modification.
4. ICRs Regarding Medicare Provider and Supplier Enrollment Provisions
We did not anticipate any information collection burden associated
with our provider and supplier enrollment proposed provisions. Since
most of the provisions that we proposed and are finalizing 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 40 presents the mean hourly wage,
the cost of fringe benefits and overhead (calculated at 100 percent of
salary), and the adjusted hourly wage.
[GRAPHIC] [TIFF OMITTED] TR09NO21.059
We did not receive comments on the ICR proposal for hospice survey
and enforcement requirements and therefore are finalizing the
application and re-application procedures for national accrediting
organizations without modification. CMS has removed the proposed burden
estimates for the surveyor qualifications and prohibition of conflicts
of interest because no information collection is actually required.
b. Application and Re-application Procedures for National Accrediting
Organizations (Sec. 488.5)
We proposed at Sec. 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.
At the time of the proposed rule, the information collection request
for the Form CMS-2567, titled ``Statement Of Deficiencies And Plan Of
Correction'' was active an approved under OMB control number 0938-0391
(Expiration date: 6/30/2021); however, it did not account for any
information collection related burden associated with AO use. As
discussed in section VII.B.2.b. of the proposed rule, we note that the
Form CMS-2567 did not include a place for the name of the AO completing
the survey and AOs are not addressed in the instructions. These were
minor revisions to the form and we submitted the revised information
collection request to OMB for approval.
We discussed in section VII.B.2.b. of the 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 noted that AOs would need to make a one-
time update to their existing proprietary electronic documentation
systems to include the Form CMS-2567. We
[[Page 62401]]
estimated 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 estimated 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 estimated 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 estimated that the cost burden related to the work performed by
two computer and information analysts would be $4,646.40 (24 hours x
$193.60 ($96.80 x 2)). The total cost across the three AOs would be
$13,939.20 (3 AOs x $4,646.40). The burden associated with this
requirement was submitted to OMB for approval under OMB control number
0938-0391. We sought comments that would help us to develop an accurate
estimate of the cost and time burden that would result from this
collection of information. No comments were received through the
proposed rule public comment period.
We sought OMB approval via the required notice and comment periods
separate from the proposed rulemaking. The revised information
collection request was announced in the Federal Register on July 13,
2021 (86 FR 36751) and the public had the opportunity to review and
comment. We received one comment on the Form CMS-2567 which was outside
the scope of the information collection request. OMB approved the
revised Form CMS-2567, titled ``Statement Of Deficiencies And Plan Of
Correction'' under OMB control number 0938-0391 (Expiration date: 02/
28/2022) on August 25, 2021.
6. HHVBP Expanded Model
In section III. of the final rule, we proposed policies necessary
to implement the expanded Home Health Value-Based Purchasing Model (see
final Sec. Sec. 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.
7. COVID-19 Reporting Requirements for Long Term Care Facilities
Section 483.80(g) sets forth the requirements for COVID-19
reporting for LTC facilities. Currently, Sec. 483.80(g)(1) states that
LTC facilities must electronically report information about COVID-19 in
a standardized format specified by the Secretary. Specific pieces of
information that must be reported are set forth in that subsection. The
required information includes, ``(viii) The COVID-19 vaccine status of
residents and staff, including total numbers of residents and staff,
numbers of residents and staff vaccinated, numbers of each dose of
COVID-19 vaccine received, and COVID-19 vaccination adverse events.''
In this rule, we are revising the requirements, in response to comments
that expressed concern about burden, to modify the reporting frequency
to weekly, unless the Secretary specifies a lesser frequency, to add
the potential for the data elements to be reduced in the future,
contingent on the state of the pandemic and at the discretion of the
Secretary. In addition, we are providing a sunset, or expiration date,
of December 31, 2024, for all of the required information in paragraph
(g)(1), except for the information set out at paragraph (g)(1)(viii)
that covers that COVID-19 vaccine status of residents and staff.
Since the infection prevention and control program (IPCP) is the
responsibility of the infection preventionist (IP), the IP would be
responsible for making the necessary changes to the policies and
procedures to comply with the requirements in this rule (42 CFR
483.80(b)). According to the Bureau of Labor Statistics (BLS), a
registered nurse in an LTC facility earns a mean hourly wage of
$34.66.\221\ For the total hourly cost, we doubled the mean hourly wage
for a 100 percent increase to cover overhead and fringe benefits,
according to standard HHS estimating procedures. Hence, the hourly-
adjusted wage for an IP in an LTC facility is $69.
---------------------------------------------------------------------------
\221\ BLS. May 2020 National Occupational Employment and Wage
Estimates United States. United States Department of Labor. Accessed
at https://www.bls.gov/oes/current/oes_nat.htm. Accessed on August
25, 2021.
---------------------------------------------------------------------------
We estimate that it would require 1 hour of the IP's time to update
the required policies and procedures to comply with the changes in this
rule. For each LTC facility, the burden would be 1 hour at an estimated
cost of $69. According to CMS, there are currently 15,401 LTC
facilities. Hence, the total burden for these requirements would be
15,401 hours (1 x 15,401) at an estimated cost of $1,062,699 (15,401 x
$69).
Comment: Some commenters disagreed with the estimate in the IFC
that reporting takes about 30 minutes, and instead they indicated that
it would take about 1 to 2 hours to complete. Additionally, many
commenters noted that the time by which the weekly reporting would have
to be submitted (every Sunday by 11:59 p.m.) is not realistic. This
requirement, they argue, is challenging to meet as there are often less
staff working on the weekends, new residents are often admitted on the
weekend, and Mondays are often holidays.
Response: After reviewing this comment and other feedback that we
have received, we have made modifications to the reporting requirement
for LTC facilities regarding COVID-19 in order to address public
commenter's concerns regarding burden. The changes in this rule will
provide the Secretary with the discretion to reduce the amount of
information they must report to the NHSN in the future. Currently they
must report no less frequently than weekly. This rule changes that to
weekly, unless the Secretary specifies a lesser frequency. In addition,
we have inserted a sunset provision for all of the information
elements, except for the COVID-19 vaccine status for its residents and
staff. The sunset or expiration date is December 31, 2024. After
consideration of the public comments we received, we are finalizing the
requirements at Sec. 483.80(g)(1) through (3) with the following
modifications: Reporting frequency is modified to weekly, unless the
Secretary specifies a lesser frequency; (2) Reporting data elements are
unchanged, but may be reduced, contingent on the state of the pandemic
and at the discretion of the Secretary; and (3) with a sunset date of
December 31, 2024 for all reporting requirements with the exclusion of
Sec. [thinsp]483.80(g)(1)(viii).
C. Submission of PRA-Related Comments
We have submitted a copy of this final rule to OMB for its review
of the rule's information collection requirements. The requirements are
not effective until they have been approved by OMB.
To obtain copies of the supporting statement and any related forms
for the collections discussed in this rule, please visit the CMS Web
site at https://
[[Page 62402]]
www.cms.gov/Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRA-Listing.
D. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and substance
of the proposed rule or a description of the subjects and issues
involved. This procedure can be waived, however, if an agency finds
good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
In section IV.D.2.d. of this final rule, we include a technical
change to Sec. 484.50(d)(5) that was not proposed. We believe that a
notice-and-comment rulemaking procedure is unnecessary for the
technical change that added ``or allowed practitioner'' at Sec.
484.50(d)(5) because we inadvertently omitted the reference at this
location during prior rulemaking (85 FR 27550). This change is
technical in nature and ensures that all that all providers, physicians
and allowed practitioners issuing orders for the patient are informed
of a discharge of the patient. This technical correction aligns with
changes made throughout the HHA CoPs in which we amended the home
health regulations by adding ``or allowed practitioner(s)''. Therefore,
we find good cause to waive the notice of proposed rulemaking.
XII. 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 case-mix adjustment factors for
significant variation in costs among different units of services.
Lastly, section 1895(b)(4)(C) of the Act requires the establishment of
wage adjustment factors that reflect the relative level of wages, and
wage-related costs applicable to home health services furnished in a
geographic area compared to the applicable national average level.
Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with
the authority to implement adjustments to the standard prospective
payment amount (or amounts) for subsequent years to eliminate the
effect of changes in aggregate payments during a previous year or years
that were the result of changes in the coding or classification of
different units of services that do not reflect real changes in case-
mix. Section 1895(b)(5) of the Act provides the Secretary with the
option to make changes to the payment amount otherwise paid in the case
of outliers because of unusual variations in the type or amount of
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires
HHAs to submit data for purposes of measuring health care quality, and
links the quality data submission to the annual applicable percentage
increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires
the Secretary to implement a new methodology used to determine rural
add-on payments for CYs 2019 through 2022.
Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by
section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively,
required the Secretary to implement a 30-day unit of service, for 30-
day periods beginning on and after January 1, 2020. The HH PPS wage
index utilizes the wage adjustment factors used by the Secretary for
purposes of Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act for
hospital wage adjustments.
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 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,\222\ 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.
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\222\ https://www.cms.gov/files/document/certification-home-health-value-based-purchasing-hhvbp-model.pdf.
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We are finalizing in this rule that 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 with CY 2022 as a pre-implementation year. As discussed in the
preamble, CY 2023 will be the first performance year, beginning January
1, 2023; and CY 2025 will be the first payment year. 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 2023 through 2027, of $3,376,000,000. 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 noted in section III.A.3.b. of the final rule,
under the expanded duration and scope of this Model, we would continue
to examine whether the 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
[[Page 62403]]
Medicare beneficiaries, as well as reductions in Medicare spending.
3. HH QRP
Section 1895(b)(3)(B)(v) of the Act authorizes the HH QRP which
requires HHAs to submit data in accordance with the requirements of the
HH QRP. Failure to submit data required under section 1895(b)(3)(B)(v)
of the Act with respect to a calendar year will result in the reduction
of the annual home health market basket percentage increase otherwise
applicable to an HHA for that calendar year by 2 percentage points.
Finalizing the removal of the Drug Education on All Medications
Provided to Patient/Caregiver measure supports the CMS Meaningful
measures framework by reducing where possible the burden on providers
and clinicians. The addition of the Potentially Preventable
Hospitalization measure, which is claims-based, to the HH QRP effective
January 1, 2022 as a replacement of 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) beginning with the CY 2023 HH QRP
addresses attribution issues identified and would capture observation
stay which are currently not addressed with the existing measures. The
public reporting of the Application of Percent of Residents
Experiencing One or More Major Falls with Injury (NQF #0674) and The
Application of Percent of Long-Term Care Hospital Patients with an
Admission and Discharge Function Assessment and a Care Plan That
Addresses Function (NQF #2631) supports the requirements that the
Secretary provide public reporting of PAC provider performance,
including HHAs, on quality measures under section 1899B(c)(1) of the
Act. Given the recent Executive order on ``Advancing Racial Equity and
Support for Underserved Communities throughout the Federal
Government,'' \223\ we proposed an earlier effective date for the
adoption of the assessment instruments whereby HHAs would begin
reporting on January 1, 2023 on items related to Social Determinants of
Health.
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\223\ Executive Order On Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government $verbar; The
White House.
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a. Virtual Supervision of HHA Aides
In accordance with sections 1861(o) and 1891 of the Act, the
Secretary has established in regulations the requirements that an HHA
must meet to participate in the Medicare program. In this rule, we are
finalizing our proposed changes to make permanent selected regulatory
blanket waivers related to home health aide supervision that we
extended to Medicare participating home health agencies during the
COVID-19 PHE.
b. Permitting Occupational Therapists To Conduct the Initial Assessment
Visit and Complete the Comprehensive Assessment for Home Health
Agencies Under the Medicare Program
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. These conforming changes are
being finalized in this regulation.
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 provisions 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 provisions will 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.
7. Survey and Enforcement Requirements for Hospice Providers
In accordance with section 407 of the CAA 2021, we are making
conforming regulations which establish new hospice program survey and
enforcement requirements. We believe these provisions not only meet the
statutory requirements but will 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.
8. COVID-19 Reporting Requirements for Long Term Care Facilities
The COVID-19 PHE has precipitated the greatest health crises since
the 1918 Influenza pandemic. Of the approximately 666,440 Americans
estimated to have died from COVID-19
[[Page 62404]]
through September 2021,\224\ over one-third are estimated to have died
during or after a nursing home stay.\225\ The development and large-
scale utilization of vaccines to prevent COVID-19 cases have the
potential to end future COVID-19 related nursing home deaths. In
addition, continued reporting of COVID-19 data in LTC facilities,
beyond the COVID-19 PHE, will have a significant positive impact by
maintaining effective surveillance of this novel virus. This final rule
finalizes the important reporting requirements that were issued in
previous IFCs so that CMS can continue to respond to facilities in need
of additional technical support and oversight, should they experience
new COVID-19 infections.
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\224\ https://covid.cdc.gov/covid-data-tracker/#trends_dailycases.
\225\ https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/.
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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.
Based on our estimates, OMB's Office of Information and Regulatory
Affairs has determined this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under Subtitle E of the Small Business Regulatory Enforcement Fairness
Act of 1996 (also known as the Congressional Review Act). Accordingly,
we have prepared, to the best of our ability, a final Regulatory Impact
Analysis that presents the costs and benefits of the rulemaking.
C. Detailed Economic Analysis
1. Impacts for the HH PPS
This final rule updates Medicare payments under the HH PPS for CY
2022. The net transfer impact related to the changes in payments under
the HH PPS for CY 2022 is estimated to be $570 million (3.2 percent).
The $570 million increase in estimated payments for CY 2022 reflects
the effects of the CY 2022 home health payment update percentage of 2.6
percent ($465 million increase), an estimated 0.7 percent increase that
reflects the effects of an updated FDL ($125 million increase) and an
estimated 0.1 percent decrease in payments due to the changes in the
rural add-on percentages for CY 2022 ($20 million decrease). We note
that we inadvertently did not account for the impact of the proposed
changes to the FDL in the CY 2022 HH PPS proposed rule (86 FR 35873).
However, in this final rule we have included the payment effects of the
new lower FDL in Table 41.
We use the latest data and analysis available. However, 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 that began
in CY 2020 and ended 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 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 41 represents how HHA revenues are likely to be affected by
the finalized policy changes 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 41 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 recalibration of the case-Mix weights offset by the
case-mix weights budget 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 final CY 2022 home health payment update
percentage. The seventh column shows the payment effects of the new
lower FDL and the last column shows the combined effects of all the
finalized provisions.
Overall, it is projected that aggregate payments in CY 2022 would
increase by 3.2 percent which reflects the 2.6 payment update
percentage increase, the 0.7 percent increase from lowering the FDL and
the 0.1 percent decrease from the effects of the rural add-on policy.
As illustrated in Table 41, 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 LUPA or paid as outlier payments, and the degree of Medicare
utilization.
BILLING CODE P
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BILLING CODE C
2. Impacts for the Expanded HHVBP Model
Based on finalized policies discussed in section III.A. of this
final rule, Tables 43 and 44 display our analysis of the distribution
of possible payment adjustments using 2019 data as the performance
year, while Table 42 provides information on the estimated impact of
this finalized 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.
Table 43 shows the value-based incentive payment adjustments for
the estimated 7,500-plus HHAs that would qualify to compete in the
HHVBP Model expansion based on the CY 2019 data stratified by size, as
defined in section III.F. of the final rule. For example, Table 43
shows California has 69 HHAs that do not provide services to at least
60 unique beneficiaries in the prior calendar year, and therefore,
would be considered to be in the smaller-volume cohort under the Model
expansion. Using 2019 performance year data and the finalized payment
adjustment of 5-percent, based on 8 outcome measures, the smaller-
volume 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.
It was brought to our attention after the close of the comment
period for the proposed rule that the larger-volume cohort section of
Table 43: HHA Cohort Payment Adjustment Distributions as presented in
the proposed rule (86 FR 35994 and 35995) inadvertently ended with the
entry for the state of Montana (MT). In this final rule, we are
presenting Table 43 from the proposed rule in its entirety, along with
the other impact tables included in the proposed rule.
Table 43 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 dual-eligible
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.
BILLING CODE P
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[[Page 62408]]
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BILLING CODE C
3. Impacts for the HH QRP for CY 2022
Estimated impacts for the HH QRP for CY 2022 are based on analysis
discussed in section XI.B. of this final rule. Finalizing the HH QRP
requirements reduces burden to the active collection under OMB control
number #0938-1279 (CMS-10545; expiration 12/31/21).
Failure to submit HH QRP 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 for that calendar year by 2
percentage points. For the CY 2021, representing HH QRP data collected
from July 1, 2019 to June 30, 2020, by HHAs, 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 out of a
total $16.7B for all HHAs.
As discussed in section IV.C. of this final rule, we are finalizing
the removal of one OASIS-based measure beginning with the CY 2023 HH
QRP. The assessment-based measure we are removing is: (1) Drug
Education on All Medications Provided to Patient/Caregiver during All
Episodes of Care. We also are replacing 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 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 would be no impact to our collection of information.
Section XI.B. of this final 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 would submit HH QRP 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
[[Page 62411]]
annualized cost to HHAs, discounted at 7 percent relative to year 2020,
over a perpetual time horizon beginning in CY 2023.
We described the estimated burden and cost reductions for these
measures in section XI.B. of this final rule.
In summary, the HH QRP measure removals results 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 45:
[GRAPHIC] [TIFF OMITTED] TR09NO21.068
We did not receive comments on the outlined burden estimates for
the HH QRP proposals.
4. Changes to the Home Health CoPs
a. Virtual Supervision of HHA Aides
In section IV.D. we are finalizing the 14-day aide supervisory
visit at Sec. 484.80(h)(1) with modification. We will permit the one
virtual supervisory visit per patient per 60-day episode. This visit
must only be permitted only in rare instances for circumstances outside
the HHA's control and must include notations in the medical record
detailing the circumstances. We are finalizing the supervisory visit
requirements for non-skilled patients with modification. We are
modifying the proposed semi-annual onsite visit to require that this
visit be conducted on ``each'' patient the aide is providing services
to rather than ``a'' patient. Lastly, we are finalizing the assessment
of deficient skills as proposed. 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
finalizing 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, this may facilitate efficiencies 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 would cause any appreciable
amount of expense or anticipated saving and we do not believe this
standard would impose any additional regulatory burden.
5. Impact of the CY 2022 Payment for Home Infusion Therapy Services
We are finalizing two provisions in this final 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 home infusion therapy service payments
using the CY 2022 GAFs. The provision to maintain the percentages for
the initial subsequent policy as well as the provision to use the CY
2022 GAFs to wage adjust home infusion therapy service payments are
both implemented in a budget neutral manner, therefore, there is no
estimated impact on payments to HIT suppliers due to these policies. 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.\226\ For CY 2022, we 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
the CY 2022 home infusion therapy services payment amounts. The
unadjusted CY 2021 rates will be updated for CY 2022 in accordance with
section 1834(u)(3) of the Act using the 5.4 percentage increase in the
CPI-U for the 12-month period ending in June of 2021 reduced by the
productivity adjustment of 0.3 percentage point, which results in a 5.1
percent increase ($300,000) to HIT suppliers for CY 2022.
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\226\ Medicare Learning Network Connects ``Special Edition:
Physician Fee Schedule Update'' (January 7, 2021). https://www.cms.gov/files/document/2021-01-07-mlnc-se.pdf.
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6. Medicare Provider and Supplier Enrollment Provisions
a. General Impact
Similar to our position regarding information collection
requirements, and except as discussed in section XI.C.6.b. of this
final rule, we did not anticipate any costs, savings, or transfers
associated with our proposed provider and supplier enrollment
provisions. Most of these provisions have been in sub-regulatory
guidance for a number of years, and we are merely incorporating them
into regulation; those 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 the proposed rule, we proposed in
new Sec. 424.540(e) that a provider or supplier may not receive
payment for services or items furnished while deactivated under Sec.
424.540(a). Existing sub-regulatory guidance permits the provider or
supplier to bill for services or items furnished up to 30 days prior to
the
[[Page 62412]]
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 the proposed rule.
Although the figure varies widely by individual provider or
supplier, internal CMS data suggests that the average provider/supplier
impacted by the aforementioned 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 again 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 x 50,000 x 0.0833). (The 0.0833 figure
represents 30 days, or 1/12 of a year.) The following table reflects
the estimated transfers associated with our proposed addition of new
Sec. 424.540(e) concerning payments for services and items furnished
by deactivated providers and suppliers:
[GRAPHIC] [TIFF OMITTED] TR09NO21.069
We did not receive comments on this estimate and are therefore
finalizing it as proposed and without modification.
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 the proposed rule.
a. Application and Re-application Procedures for National Accrediting
Organizations (Sec. 488.5)
We proposed at Sec. 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 sought comments that would help us to develop an accurate estimate
of the cost and time burden that would result from this collection of
information.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification.
b. Release and Use of Accreditation Surveys (Sec. 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.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification.
c. Hospice Hotline (Sec. 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.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification.
d. Surveyor Qualifications and Prohibition of Conflicts of Interest
(Sec. 488.1115)
We proposed at Sec. 488.1115, to require AO hospice program
surveyors to complete the CMS hospice basic training currently
available online. We have removed the proposed burden estimates for the
surveyor qualifications because we do not expect any increase in burden
for this provision. In fact, for AOs with hospice programs, this may
facilitate efficiencies by removing the need for AOs to develop and
maintain their own training courses based on the CMS regulations and
process. Therefore, the regulatory impact (including benefits of such
provisions) is negligible. Additionally, we did not receive comments on
the estimated impact.
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 changes would
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.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification.
e. Survey Teams (Sec. 488.1120)
We proposed at Sec. 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. 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.
[[Page 62413]]
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 x 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 x $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 x 5 days = 40 hours), would
cost $5,082.40 per survey, times 960 surveys per year, or $4,879,104
per year. We sought 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.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification.
f. Consistency of Survey Results (Sec. 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.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification.
g. Enforcement Remedies (Sec. Sec. 488.1200 through Sec. 488.1265)
We proposed enforcement remedies for hospices consistent with the
established alternative sanctions for HHAs. In CY 2019, out of 11,738
deemed and non-deemed 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. These data were
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.
We did not receive comments on this estimated impact and therefore
are finalizing this section without modification. However, we have
removed the SFP regulatory impact analysis because we are not
finalizing the SFP in this rule.
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 final rule does not impose any new information collection
requirements under the IRF QRP. However, this final 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 the proposed rule, for purposes of
calculating the FY 2023 Annual Increase Factor (AIF), we proposed that
IRFs would begin collecting 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 collecting 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. If finalized as proposed, IRFs would use the
IRF-PAI V4.0 to submit IRF QRP data.
We are finalizing the proposed IRF QRP requirements, which do not
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 provision does not impose any new information
collection requirements under the LTCH QRP. However, this proposed
provision does reference associated information collections that are
not discussed in the regulation text of the proposed or this final
rule. The following is a discussion of this information collection
discussed in section XI. of the proposed rule, 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 the proposed rule for purposes of
calculating the FY 2023 Annual Payment Update (APU), we proposed that
LTCHs would begin collecting 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
LTCHs would begin to collect data on certain
[[Page 62414]]
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. If finalized as
proposed, LTCHs would use the LTCH Continuity Assessment Record and
Evaluation (CARE) Data Set (LCDS) V5.0 to submit LTCH QRP data.
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).
9. COVID-19 Reporting Requirements for Long Term Care Facilities
a. Anticipated Cost
Section 483.80(g) sets forth the requirements for COVID-19
reporting for LTC facilities. Currently, Sec. 483.80(g)(1) states that
LTC facilities must electronically report information about COVID-19 in
a standardized format specified by the Secretary. Specific pieces of
information that must be reported are set forth in that subsection. One
of the information requirements is ``the COVID-19 vaccine status of
residents and staff, including total numbers of residents and staff,
numbers of residents and staff vaccinated, numbers of each dose of
COVID-19 vaccine received, and COVID-19 vaccination adverse events''.
This final rule requires LTC facilities to continue to report
certain information required by CDC's NHSN. However, this change will
provide flexibility if there are future changes to the information NHSN
requires to be reported. In addition, we are revising paragraph (g)(1)
to include a sunset, or expiration date, of December 31, 2024, for all
of the required information in paragraph (g)(1), except for the
information set out at (g)(1)(viii) that covers that COVID-19 vaccine
status of residents and staff. In Sec. 483.80(g)(2), we are removing
the ``less'' after ``no'' and inserting ``more'' so that the required
frequency of reporting is no more than weekly instead of no less than
weekly.
For the estimated costs contained in the analysis below, we used
data from the United States Bureau of Labor Statistics (BLS) to
determine the mean hourly wage for the positions used in this
analysis.\227\ For the total hourly cost, we doubled the mean hourly
wage for a 100 percent increase to cover overhead and fringe benefits,
according to standard HHS estimating procedures. If the total cost
after doubling resulted in .50 or more, the cost was rounded up to the
next dollar. If it was 0.49 or below, the total cost was rounded down
to the next dollar. The total costs used in this analysis are indicated
in the chart below.
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\227\ BLS. May 2020 National Occupational Employment and Wage
Estimates United States. United States Department of Labor. Accessed
at https://www.bls.gov/oes/current/oes_nat.htm. Accessed on August
25, 2021.
[GRAPHIC] [TIFF OMITTED] TR09NO21.070
As determined in the COI section, the burden for ICR requirements
for this rule would be 15,401 hours (1 x 15,401) at an estimated cost
of $1,062,669 (15,401 x $69). In addition to the ICR requirements,
there would be addition requirements for the IP to report on these
changes in policies and procedures to the medical director, director of
nursing (DON), and an administrator. We believe this would require an
addition 10 minutes or 0.1666 hours for the IP, medical director, DON,
and administrator. According to Table 1 above, the medical director
earns an adjusted hourly wage of $171. Thus, the burden for the medical
director would be 0.1666 hours at an estimated cost of $28.50 (0.1666 x
$171). The adjusted hourly wage for both the DON and administrator is
$96. Thus, the burden for each of them would be 0.1666 hours at an
estimated cost of $16 (0.1666 x $96) and for both it would be 0.3332
hours at an estimated cost of $32. The adjust hourly wage for the IP is
$69. The burden for the IP would be 0.1666 hours at an estimated cost
of $11.50 (0.1666 x $69). Thus, the burden for each LTC facility would
be 0.67 hour or about 40 minutes (0.1666 x 4) at an estimated cost of
$72 ($28.50 + $16 + $16 + $11.50). For all 15,401 LTC facilities the
total burden would be 10,319 hours (0.67 x 15,401) at an estimated cost
of $1,108,872 (15,401 x $72).
Thus, the total burden for the requirements in this rule is 25,720
hours (15,401 + 10,319) at an estimated cost of $2,171,541 ($1,062,669
+ $1,108,872).
b. Anticipated Benefits
These changes will provide LTC facilities will more flexibility and
eliminate unnecessary burden on these facilities by revising the
requirements for the reporting frequency to no more
[[Page 62415]]
than weekly, with the possibility of reduced reporting at the
discretion of the Secretary and the data reporting elements may be
changed in the future. The reporting requirements, with the exception
of the requirements at Sec. [thinsp]483.80 (g)(1)(viii), will end on
December 31, 2024. We did not receive comments on this proposal and
therefore are finalizing this provision without modification.
D. Limitations of Our Analysis
Our estimates of the effects of this final rule are subject to
significant uncertainty. It is difficult to estimate the burden and
savings from the proposed changes that are being finalized in this rule
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 sought 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 final rule, we must
estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that would review the rule, we assume that the total number of unique
reviewers of this year's final rule would be the similar to the number
of reviewers on this year's proposed rule. We acknowledge that this
assumption may understate or overstate the costs of reviewing this
rule. It is possible that not all commenters reviewed this year's rule
in detail, and it is also possible that some reviewers chose not to
comment on the proposed rule. For these reasons we believe that the
number of past commenters would be a fair estimate of the number of
reviewers of this rule. We also recognize that different types of
entities are in many cases affected by mutually exclusive sections of
this final rule, and therefore for the purposes of our estimate we
assume that each reviewer reads approximately 50 percent of the rule.
While we solicited comments on the approach in estimating the number of
entities which would review the proposed rule and the assumption of how
much of the rule reviewers would read, we did not receive any comments.
Therefore, using the wage information from the BLS for medical and
health service managers (Code 11-9111), we estimate that the cost of
reviewing this rule is $114.24 per hour, including overhead and fringe
benefits (https://www.bls.gov/oes/current/oes_nat.htm. Assuming an
average reading speed of 250 words per minute, we estimate that it
would take approximately 5.73 hours for the staff to review half of
this final rule, which consists of approximately 171,832 words. For
each HHA that reviews the rule, the estimated cost is $654.34 (5.73
hours x $114.24). Therefore, we estimate that the total cost of
reviewing this final rule is $135,447.61 ($654.34 x 207 reviewers). For
purposes of this estimate, the number of reviewers of this year's rule
is equivalent to the number of comments received for the CY 2022 HH PPS
proposed rule.
F. Alternatives Considered
1. HH PPS
For the CY 2022 HH PPS final rule, we considered alternatives to
the provisions articulated in section II. of this final 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 rate setting, which would be CY 2020 claims data. Additionally,
we considered alternatives to our case-mix recalibration proposal.
These alternatives included an option to 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. HHVBP
We considered alternatives to the proposed policies in sections
III.A. and III.B. of the 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
State- and volume-based cohorts as the original HHVBP Model in lieu of
the national volume-based cohorts we proposed. However, this approach
could
[[Page 62416]]
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 State-level 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.
We refer readers to Table 43 of this final rule for an analysis of the
shifts of expenditures, as represented by the average payment
adjustments for small- and large-volume HHAs in each of the States,
territories, and the District of Columbia, simulated with the proposed
national size-based cohorts using 2019 data and a maximum adjustment of
5 percent. When the small- and large-volume HHAs in each
of the States, territories, and the District of Columbia are combined,
the average payment adjustment for the majority of States, territories,
and the District of Columbia is within 1 percent, with
none exceeding 2 percent. Relative to the State- and
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.
3. Deactivation Payment Prohibition
As discussed in section VI.B. of the proposed rule, we proposed in
new Sec. 424.540(e) that a provider or supplier may not receive
payment for services or items furnished while deactivated under Sec.
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 the proposed and final rules, we do not believe a provider or
supplier should be effectively rewarded for its non-adherence 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.
4. COVID-19 Reporting in Long-Term Care Facilities
We considered retaining all of the requirements in Sec. 483.80(g).
However, we anticipate that NHSN will change the information items that
are required in the future. The change made to this section will enable
LTC facilities to continue to report the information required by the
NHSN without requiring the facilities to report information that the
NHSN no longer requires. We also considered not setting a sunset or
expiration date for all of the requirements for the information
elements in paragraph (g)(1). However, we do not believe that all of
this information will be needed in the future. The information on the
vaccine status for the residents and staff is necessary so that health
authorities can assess the needs in this area though. Thus, we have
added the sunset date of December 31, 2024 for all of the information
elements, except for paragraph (g)(1)(viii) which covers the
vaccinations. Hence, this reduces the burden for the LTC facilities
while maintaining the requirement to report information so that health
authorities can assess the COVID-19 vaccination environment in LTC
facilities. There has also been some confusion created by the language
in (g)(2), which indicated that the frequency of the reporting was to
be ``no less than weekly''. We considered retaining the language in
(g)(2); however, we believe that the confusion was adding undue burden
to some LTC facilities. Thus, we have changed the language to read,
``no more than weekly'' to address any confusion. LTC facilities should
report as NHSN requires.
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 46, 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.
[GRAPHIC] [TIFF OMITTED] TR09NO21.071
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 47, we have prepared an accounting statement showing
the classification of the expenditures associated with this final rule
as they relate to hospitals and SNFs. Table 47 provides our best
estimate of the decrease in Medicare payments under the expanded HHVBP
Model.
[[Page 62417]]
[GRAPHIC] [TIFF OMITTED] TR09NO21.072
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 48, we have prepared an accounting statement showing
the classification of the expenditures associated with this final rule
as they relate to HHAs. Table 48 provides our best estimate of the
decrease in Medicare payments.
[GRAPHIC] [TIFF OMITTED] TR09NO21.073
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
\228\ and approximately 96 percent of HHAs and home infusion therapy
suppliers are considered small entities. Table 49 shows the number of
firms, revenue, and estimated impact per home health care service
category.
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\228\ https://www.sba.gov/sites/default/files/2019-08/SBA%20Table%20of%20Size%20Standards_Effective%20Aug%2019%2C%202019_Rev.pdf.
[GRAPHIC] [TIFF OMITTED] TR09NO21.074
The economic impact assessment is based on estimated Medicare
payments (revenues) and HHS's practice in interpreting the RFA is to
consider effects economically ``significant'' only if greater than 5
percent of providers
[[Page 62418]]
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 final rule, our
provision to prohibit payments for services and items furnished by
deactivated providers and suppliers will affect only a very limited
number of Medicare providers and suppliers. Therefore, the Secretary
has determined that this HH PPS final 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 a 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 43 and 44 of this
final rule for our analysis of payment adjustment distributions by
State, HHA characteristics, HHA size and percentiles.
Thus, the Secretary has certified that this final 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.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a metropolitan statistical area and has fewer
than 100 beds. This rule is not applicable to hospitals. Therefore, the
Secretary has certified that this final rule will not have a
significant economic impact on the operations of small rural hospitals.
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 final rule under these criteria of
Executive Order 13132, and have determined that it will not impose
substantial direct costs on State or local governments.
K. Conclusion
In conclusion, we estimate that the provisions in this final rule
will result in an estimated net increase in home health payments 3.2
percent for CY 2022 ($570 million). The $570 million increase in
estimated payments for CY 2022 reflects the effects of the CY 2022 home
health payment update percentage of 2.6 percent ($465 million
increase), a 0.7 percent increase in payments due to the new lower FDL
ratio, which will increase outlier payments in order to target to pay
no more than 2.5 percent of total payments as outlier payments ($125
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 final rule.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on October 28, 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 483
Grant programs-health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
and recordkeeping requirements, Safety.
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 amends 42 CFR chapter IV as follows:
PART 409--HOSPITAL INSURANCE BENEFITS
0
1. The authority citation for part 409 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 409.43 is amended--
0
a. By revising the paragraph (b) heading;
0
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``;
0
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
[[Page 62419]]
0
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:
Sec. 409.43 Plan of care requirements.
* * * * *
(b) Physician's or allowed practitioner's orders. * * *
* * * * *
PART 424--CONDITIONS FOR MEDICARE PAYMENT
0
3. The authority for part 424 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
4. Section 424.520 is amended by revising paragraph (d) to read as
follows:
Sec. 424.520 Effective date of Medicare 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.
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5. Section 424.521 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 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 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)(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.
* * * * *
0
6. Section 424.522 is added to read as follows:
Sec. 424.522 Additional effective dates.
(a) Reassignments. A reassignment of benefits under Sec. 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.
0
7. Section 424.525 is amended--
0
a. By revising the section heading and paragraph (a)(1);
0
b. In paragraphs (a)(2) and (3) and (b) by removing the phrase
``prospective provider'' and adding the word ``provider'' in its place;
and
0
c. By adding paragraph (e).
The revision and addition read as follows:
Sec. 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 e-mail 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
[[Page 62420]]
paragraphs (e)(1) through (3) of this section.
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8 Section 424.526 is added to read as follows:
Sec. 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
paragraph (a)(2) 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 Sec. 424.535 or reapplication bar under Sec. 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.
(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.
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9. Section 424.540 is amended--
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a. By revising paragraph (a)(2);
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b. By adding paragraphs (a)(4) through (8);
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c. By revising paragraphs (b)(1) and (c); and
0
d. By adding paragraphs (d) and (e).
The revisions and additions read as follows:
Sec. 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
Sec. 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 non-compliance 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
[[Page 62421]]
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.
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10. Section 424.550 is amended by revising paragraph (b)(2)(i) to read
as follows:
Sec. 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 the exception in this paragraph
(b)(2)(i), low utilization or no utilization cost reports do not
qualify as full cost reports.
* * * * *
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
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11. The authority for part 483 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.
0
12. Section 483.80 is amended by revising paragraph (g) to read as
follows:
Sec. 483.80 Infection control.
* * * * *
(g) COVID-19 reporting. Until December 31, 2024, with the exception
of the requirements in paragraph (g)(1)(viii) of this section, the
facility must do all of the following:
(1) Electronically report information about COVID-19 in a
standardized format specified by the Secretary. To the extent as
required by the Secretary, this report must include the following:
(i) Suspected and confirmed COVID-19 infections among residents and
staff, including residents previously treated for COVID-19.
(ii) Total deaths and COVID-19 deaths among residents and staff.
(iii) Personal protective equipment and hand hygiene supplies in
the facility.
(iv) Ventilator capacity and supplies in the facility.
(v) Resident beds and census.
(vi) Access to COVID-19 testing while the resident is in the
facility.
(vii) Staffing shortages.
(viii) The COVID-19 vaccine status of residents and staff,
including total numbers of residents and staff, numbers of residents
and staff vaccinated, numbers of each dose of COVID-19 vaccine
received, and COVID-19 vaccination adverse events.
(ix) Therapeutics administered to residents for treatment of COVID-
19.
(2) Provide the information specified in paragraph (g)(1) of this
section weekly, unless the Secretary specifies a lesser frequency, to
the Centers for Disease Control and Prevention's National Healthcare
Safety Network. This information will be posted publicly by CMS to
support protecting the health and safety of residents, personnel, and
the general public.
(3) Inform residents, their representatives, and families of those
residing in facilities by 5 p.m. the next calendar day following the
occurrence of either a single confirmed infection of COVID-19, or three
or more residents or staff with new-onset of respiratory symptoms
occurring within 72 hours of each other. This information must do all
of the following:
(i) Not include personally identifiable information.
(ii) Include information on mitigating actions implemented to
prevent or reduce the risk of transmission, including if normal
operations of the facility will be altered.
(iii) Include any cumulative updates for residents, their
representatives, and families at least weekly or by 5 p.m. the next
calendar day following the subsequent occurrence of either: Each time a
confirmed infection of COVID-19 is identified, or whenever three or
more residents or staff with new onset of respiratory symptoms occur
within 72 hours of each other.
* * * * *
PART 484--HOME HEALTH SERVICES
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13. The authority citation for part 484 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
Sec. 484.50 [Amended]
0
14. Section 484.50 is amended in paragraph (d)(5)(i) by removing the
phrase ``representative (if any), the physician(s) issuing orders'' and
adding in its place the phrase ``the representative (if any), the
physician(s) or allowed practitioner(s) issuing orders``.
0
15. Section 484.55 is amended by revising paragraphs (a)(2) and (b)(3)
to read as follows:
Sec. 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 (speech-language pathology or physical
therapy) that establishes program eligibility.
(b) * * *
(3) When physical therapy, speech-language 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.
* * * * *
0
16. Section 484.80 is amended by:
0
a. Revising paragraph (h)(1)(i);
0
b. Redesignating paragraphs (h)(1)(ii) and (iii) as paragraphs
(h)(1)(iii) and (iv), respectively;
0
c. Adding a new paragraph (h)(1)(ii); and
0
d. Revising paragraphs (h)(2) and (3).
The revisions and addition read as follows:
Sec. 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 on the rare occasion by
[[Page 62422]]
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 1
virtual supervisory assessment per patient in a 60-day episode.
* * * * *
(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 each 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.
* * * * *
0
17. The heading for subpart F is revised to read as follows:
Subpart F--Home Health Value-Based Purchasing (HHVBP) Models
0
18. Add an undesignated center heading before Sec. 484.300 to read as
follows:
HHVBP Model Components for Competing Home Health Agencies Within State
Boundaries for the Original HHVBP Model
* * * * *
0
19. Section 484.305 is amended by revising the definition of
``Applicable percent`` to read as follows:
Sec. 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.
* * * * *
Sec. 484.315 [Amended]
0
20. Section 484.315 is amended by removing paragraph (d).
0
21. Add an undesignated center heading and Sec. Sec. 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 this 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 Value-Based 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
Sec. 484.340 Basis and scope of this 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 of the Act.
Sec. 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 smaller-volume 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
OASIS-based measures.
(2) Twenty home health episodes of care per year for each of the
claims-based 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 Sec. Sec. 484.200 through 484.245.
Improvement threshold means an individual competing HHA's
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 Sec. 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 U.S. 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 Sec. 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.
Pre-Implementation year means CY 2022.
Smaller-volume cohort means the group of competing HHAs that are
exempt from participation in the HHCAHPS survey in accordance with
Sec. 484.245.
Total Performance Score (TPS) means the numeric score ranging from
0 to 100
[[Page 62423]]
awarded to each competing HHA based on its performance under the
expanded HHVBP Model.
Sec. 484.350 Applicability of the Expanded Home Health Value-Based
Purchasing (HHVBP) Model.
(a) General rule. The expanded HHVBP Model applies to all Medicare-
certified 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 calendar year (CY) 2021, and the
first performance year is the first full calendar year (beginning with
CY 2023) following the baseline year.
Sec. 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, for the pre-implementation year and each 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.
Sec. 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 HHCAHPS Survey-based) weighted
at 35 percent for the OASIS-based measure category, 35 percent for the
claims-based 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
[[Page 62424]]
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.
Sec. 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).
Sec. 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
larger-volume and smaller-volume cohorts nationwide based on the
performance standards in this part 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 Sec. 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 Sec. 484.345.
(2) The competing HHA's Total Performance Score divided by 100.
(3) The linear exchange function slope.
Sec. 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 HHA-specific 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) of this section.
(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.
(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
0
22. The authority citation for part 488 continues to read as follows:
Authority: 42 U.S.C 1302 and 1395hh.
0
23. Section 488.2 is amended by adding provision ``1822'' in numerical
order to read as follows:
Sec. 488.2 Statutory basis.
* * * * *
1822--Hospice Program survey and enforcement procedures.
* * * * *
[[Page 62425]]
0
24. Section 488.5 is amended by adding paragraph (a)(4)(x) to read as
follows:
Sec. 488.5 Application and re-application procedures for national
accrediting organizations.
* * * * *
* * * * *
(x) For accrediting organizations applying for approval or re-
approval of CMS-approved hospice programs, a statement acknowledging
that the accrediting organization (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.
* * * * *
0
25. Section 488.7 is amended by revising paragraph (b) and adding
paragraph (c) to read as follows.
Sec. 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 accrediting 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.
0
26. Section 488.28 is amended by revising the section heading to read
as follows:
Sec. 488.28 Providers or suppliers, other than SNFs, NFs, HHAs, and
Hospice programs with deficiencies.
* * * * *
0
27. 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.
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 payment for all new patient admissions.
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
Sec. 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.
Sec. 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 Sec. 488.1.
Condition-level deficiency means noncompliance as described in
Sec. 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
standard-level.
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.
Sec. 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
(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.
Sec. 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
[[Page 62426]]
Course, and additional training as specified by CMS.
(b) Disqualifications. Surveyor(s) must disclose actual or
perceived conflicts of interest prior to participating in a hospice
program survey and be provided the opportunity to recuse themselves as
necessary. 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
Sec. 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
Sec. 411.351 of this chapter, who is a patient of the hospice program
to be surveyed.
Sec. 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 Sec. 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.
Sec. 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.
Subpart N--Enforcement Remedies for Hospice Programs With
Deficiencies
Sec. 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.
Sec. 488.1205 Definitions.
As used in this subpart--
Directed plan of correction means CMS or the temporary manager
(with CMS/survey agency (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 condition-level 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 non-compliance 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 correct
deficiencies identified in the hospice program's operation.
Sec. 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 Sec. 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 Sec. 488.1220 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 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
Sec. 488.1245(e), once the administrative determination is final.
(3) Date of enforcement action. The notice periods specified in
Sec. Sec. 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.
Sec. 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.
[[Page 62427]]
(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.
Sec. 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 Sec. 489.53 of this chapter, for a period not to exceed 6
months:
(a) Civil money penalties.
(b) Suspension of payment for all new patient admissions.
(c) Temporary management of the hospice program.
(d) Directed plan of correction.
(e) Directed in-service training.
Sec. 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 Sec. 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-calendar day notice. Except for civil money penalties, for
all remedies specified in Sec. 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 Sec. 488.1210(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.
Sec. 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 Sec.
488.1220(a) through (e) in lieu of termination, for a period not to
exceed 6 months.
(b) 15-calendar day notice. Except for civil money penalties, for
all remedies specified in Sec. 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 Sec. 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
Sec. 488.1260(a), CMS terminates the hospice program's provider
agreement in accordance with Sec. 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.
Sec. 488.1235 Temporary management.
(a) Application. 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
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 the remedy in
paragraph (a) of this section, CMS notifies the hospice program in
accordance with Sec. 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 Sec. 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.
Sec. 488.1240 Suspension of payment for all new patient admissions.
(a) Application. (1) CMS may suspend payment for all new admissions
to a hospice program on or after the date on which the Secretary
determines that remedies should be imposed.
(2) CMS considers the remedy in paragraph (a)(1) of this section
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 for all
[[Page 62428]]
new admissions, CMS provides the hospice program notice of the
suspension of payment in accordance with Sec. 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) The suspension of payment for all new
admissions remedy may be imposed anytime a hospice program is found to
be out of substantial compliance with the conditions of participation.
(ii) The suspension of payment for all new admissions 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 for all new admissions 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. The remedy in paragraph (a) of
this section 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.
Sec. 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 civil money penalty (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 Sec. 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 system-wide 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 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
[[Page 62429]]
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 Sec. 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 Sec. 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) Accrual 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.
(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 Sec. 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.
Sec. 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 the remedy in paragraph (a) of
this section, CMS notifies the hospice program in accordance with Sec.
488.1210(e).
[[Page 62430]]
(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 Sec.
488.1220.
(2) Terminates the provider agreement.
Sec. 488.1255 Directed in-service training.
(a) Application. CMS may require the staff of a hospice program to
attend in-service 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 the remedy in
paragraph (a) of this section, CMS notifies the hospice program in
accordance with Sec. 488.1210(e).
(2) Action following training. After the hospice program staff has
received in-service training, if the hospice program has not achieved
substantial compliance, CMS may impose one or more other remedies
specified in Sec. 488.1220.
(3) Payment. The hospice program pays for the directed in-service
training for its staff.
Sec. 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, 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 paragaph (a) 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 Sec. 488.1265.
Sec. 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 Sec. 488.1260(a)(1).
(c) Notice. CMS notifies the hospice program and the public of the
termination, in accordance with procedures set forth in Sec. 489.53 of
this chapter.
(d) Procedures for termination. CMS terminates the provider
agreement in accordance with procedures set forth in Sec. 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 Sec. 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
0
28. 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 1395hh.
0
29. Section 489.28 is amended by revising paragraphs (d) and (e) to
read as follows:
Sec. 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
[[Page 62431]]
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, non-borrowed) 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.
* * * * *
Sec. 489.53 [Amended]
0
30. 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
0
31. The authority citation for part 498 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.
0
32. Section 498.1 is amended by adding paragraph (l) to read as
follows:
Sec. 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.
0
33. Section 498.3 is amended--
0
a. By revising paragraph (b)(13);
0
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'';
0
c. By revising paragraph (b)(14)(i); and
0
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:
Sec. 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 Sec.
488.406, Sec. 488.820, or Sec. 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 Sec.
488.438(e), Sec. 488.845(h), or Sec. 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 Sec. 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 Sec. Sec.
488.845(h) and 488.1195(h) of this chapter); or
* * * * *
Sec. 498.60 [Amended]
0
34. Section 498.60 is amended--
0
a. In paragraph (c)(1) by removing the reference ``Sec. Sec.
488.438(e) and 488.845(h)'' and adding in its place the reference
``Sec. Sec. 488.438(e), 488.845(h), and 488.1195(g)``.
0
b. In paragraph (c)(2) by removing the phrase ``or HHA'' and adding in
its place the phrase ``HHA, or hospice program''.
Dated: October 29, 2021.
Xavier Becerra,
Secretary Department of Health and Human Services.
[FR Doc. 2021-23993 Filed 11-2-21; 4:15 pm]
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