Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Proposed Model Expansion; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; Inpatient Rehabilitation Facility Quality Reporting Program Requirements; and Long-Term Care Hospital Quality Reporting Program Requirements
| Published date | 07 July 2021 |
| Citation | 86 FR 35874 |
| Record Number | 2021-13763 |
| Section | Proposed rules |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 127 (Wednesday, July 7, 2021)
[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Proposed Rules]
[Pages 35874-36016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13763]
[[Page 35873]]
Vol. 86
Wednesday,
No. 127
July 7, 2021
Part IIDepartment of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------42 CFR Parts 409, 424, et al.Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment
System Rate Update; Home Health Value-Based Purchasing Model
Requirements and Proposed Model Expansion; Home Health Quality
Reporting Requirements; Home Infusion Therapy Services Requirements;
Survey and Enforcement Requirements for Hospice Programs; Medicare
Provider Enrollment Requirements; Inpatient Rehabilitation Facility
Quality Reporting Program Requirements; and Long-Term Care Hospital
Quality Reporting Program Requirements; Proposed Rule
Federal Register / Vol. 86 , No. 127 / Wednesday, July 7, 2021 /
Proposed Rules
[[Page 35874]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 424, 484, 488, 489, and 498
[CMS-1747-P]
RIN 0938-AU37
Medicare and Medicaid Programs; CY 2022 Home Health Prospective
Payment System Rate Update; Home Health Value-Based Purchasing Model
Requirements and Proposed Model Expansion; Home Health Quality
Reporting Requirements; Home Infusion Therapy Services Requirements;
Survey and Enforcement Requirements for Hospice Programs; Medicare
Provider Enrollment Requirements; Inpatient Rehabilitation Facility
Quality Reporting Program Requirements; and Long-Term Care Hospital
Quality Reporting Program Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would set forth routine updates to the home
health and home infusion therapy services payment rates for calendar
year (CY) 2022 in accordance with existing statutory and regulatory
requirements. This rule also provides monitoring and analysis of the
Patient-Driven Groupings Model (PDGM); solicits comments on a
methodology for determining the difference between assumed versus
actual behavior change on estimated aggregate expenditures for home
health payments as result of the change in the unit of payment to 30
days and the implementation of the PDGM case-mix adjustment
methodology; and proposes to recalibrate the PDGM case-mix weights,
functional levels, and comorbidity adjustment subgroups while
maintaining the low utilization payment adjustment (LUPA) thresholds
for CY 2022. Additionally, this rulemaking proposes to utilize the
physical therapy LUPA add-on factor to establish the occupational
therapy add-on factor for the LUPA add-on payment amounts; and make
conforming regulations text changes to reflect that allowed
practitioners are able to establish and review the plan of care.
This rulemaking also proposes changes to the Home Health Quality
Reporting Program (QRP) to remove one measure, remove two claims-based
measures and replace them with one claims-based measure, publicly
report two measures, propose a modification to the effective date for
the reporting of the Transfer of Health to Provider-Post Acute Care and
Transfer of Health to Patient-Post Acute Care (TOH) measures and
Standardized Patient Assessment Data Elements and requests information
on two topics: Advancing to digital quality measurement through the use
of Fast Healthcare Interoperability Resources and our efforts
surrounding closing the health equity gap. It also proposes
modifications to the effective date for the reporting of TOH measures
and certain Standardized Patient Assessment Data Elements.
Additionally, this proposed rule requests information on two topics:
Advancing to digital quality measurement through the use of Fast
Healthcare Interoperability Resources and our efforts surrounding
closing the health equity gap. It also proposes modifications to the
effective date for the reporting of TOH measures and certain
Standardized Patient Assessment Data Elements in the Inpatient
Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH)
QRP. In addition, this proposed rule would incorporate into regulation
certain Medicare provider and supplier enrollment policies.
In addition, this rulemaking proposes to make permanent selected
regulatory blanket waivers related to home health aide supervision that
were issued to Medicare participating home health agencies during the
COVID-19 public health emergency (PHE), and would update the home
health conditions of participation to implement Division CC, section
115 of the Consolidated Appropriations Act, 2021 (CAA 2021) regarding
occupational therapists completing the initial and comprehensive
assessments reflect these changes.
This proposed rule also would expand the Home Health Value-Based
Purchasing (HHVBP) Model, beginning January 1, 2022, to the 50 States,
territories, and District of Columbia. This rulemaking also proposes to
end the original HHVBP Model one year early for the home health
agencies (HHAs) in the nine original Model States, such that CY 2020
performance data would not be used to calculate a payment adjustment
for CY 2022 under the original Model.
Additionally, this proposed rule establishes survey and enforcement
requirements for hospice programs as set forth in Division CC, section
407, of the CAA 2021.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on August 27, 2021.
ADDRESSES: In commenting, please refer to file code CMS-1747-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1747-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1747-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Brian Slater, (410) 786-5229, for home
health and home infusion therapy payment inquiries. For general
information about home infusion payment, send your inquiry via email to
[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, send your inquiry via email to [email protected].
For information about the Home Health Quality Reporting Program (HH
QRP), send your inquiry via email to [email protected].
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.
[[Page 35875]]
For information about the survey and enforcement requirements for
hospice programs, send your inquiry via email to
[email protected].
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on
that website to view public comments.
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Provisions of This Rule
C. Summary of Costs, Transfers, and Benefits
II. Home Health Prospective Payment System
A. Overview of the Home Health Prospective Payment System
B. Proposed Provisions for Payment Under the HH PPS
III. Home Health Value-Based Purchasing (HHVBP) Model
A. Proposal To Expand the HHVBP Model Nationwide
B. Provisions Under the Home Health Value-Based Purchasing
(HHVBP) Original Model
IV. Home Health Quality Reporting Program (HH QRP) and Other Home
Health Related Provisions
A. Vaccinations for Home Health Agency Health Care Personnel
B. Advancing Health Information Exchange
C. Home Health Quality Reporting Program (HH QRP)
D. Proposed Changes to the Home Health Conditions of
Participation
V. Home Infusion Therapy Services: Annual Payment Updates for CY
2022
A. Home Infusion Therapy Payment Categories
B. Payment Adjustments for CY 2022 Home Infusion Therapy
Services
C. CY 2022 Payment Amounts for Home Infusion Therapy Services
VI. Medicare Provider and Supplier Enrollment Changes
A. Background--Provider and Supplier Enrollment Process
B. Proposed Provisions
VII. Survey and Enforcement Requirements for Hospice Programs
A. Background
B. Provisions of the Proposed Rule
VIII. Requests for Information
A. Fast Healthcare Interoperability Resources (FHIR) in Support
of Digital Quality Measurement in Post-Acute Care Quality Reporting
Programs--Request for Information
B. Closing the Health Equity Gap in 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. Proposal of a Revised Compliance Date for Certain Inpatient
Rehabilitation Facility (IRF) QRP Reporting Requirements
B. Proposal of a Revised Compliance Date for Certain Long-Term
Care Hospital (LTCH) QRP Reporting Requirements
X. Collection of Information Requirements
A. Statutory Requirement for Solicitation of Comments
B. Collection of Information Requirements
C. Submission of PRA-Related Comments
XI. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Detailed Economic Analysis
D. Limitations of Our Analysis
E. Regulatory Review Cost Estimation
F. Alternatives Considered
G. Accounting Statement and Tables
H. Regulatory Flexibility Act (RFA)
I. Unfunded Mandates Reform Act (UMRA)
J. Federalism
K. Conclusion
L. Executive Order 12866
Regulations Text
I. Executive Summary
A. Purpose
1. Home Health Prospective Payment System (HH PPS)
This proposed rule provides preliminary monitoring analysis of the
implementation of the PDGM, discusses the change in the unit of payment
to 30 days and the implementation of the PDGM case-mix adjustment
methodology on estimated aggregate expenditures under the HH PPS, and
includes a comment solicitation on the methodology for determining the
difference between assumed versus actual behavior change on estimated
aggregate expenditures for home health payments. This proposed rule
would update the payment rates for HHAs for CY 2022, as required under
section 1895(b) of the Social Security Act (the Act). This rule also
proposes to maintain the CY 2021 LUPA thresholds for CY 2022. However,
the rule also proposes to recalibrate the case-mix weights under
section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for 30-day periods of
care in CY 2022. This proposed rule would update the CY 2022 fixed-
dollar loss ratio (FDL) for outlier payments (outlier payments as a
percentage of estimated total payments are not to exceed 2.5 percent,
as required by section 1895(b)(5)(A) of the Act). Finally, this rule
proposes to use the physical therapy (PT) add-on factor to establish
the occupational therapy (OT) LUPA add-on factor and proposes
conforming regulations text changes at 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 proposed rule, we would expand the Home Health Value-Based
Purchasing (HHVBP) Model to all Medicare-certified HHAs in the 50
States, territories, and District of Columbia beginning January 1, 2022
with CY 2022 as the first performance year and CY 2024 as the first
payment year, based on HHA performance in CY 2022. This rule also
proposes to end the original HHVBP Model 1 year early for the HHAs in
the nine original Model States, such that CY 2020 performance data
would not be used to calculate a payment adjustment for CY 2022.
3. Home Health (HH) Quality Reporting Program (HH QRP), Inpatient
Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH)
QRP
This proposed rule would update the HH QRP by removing an OASIS-
based measure, the Drug Education on All Medications Provided to
Patient/Caregiver During All Episodes of Care measure, from the HH QRP
under measure removal factor 1: Measure performance among HHAs is so
high and unvarying that meaningful distinctions in improvements in
performance can no longer be made. This proposed rule also proposes to
replace the Acute Care Hospitalization During the First 60 Days of Home
Health (NQF #0171) measure and Emergency Department Use Without
Hospitalization During the First 60 Days of Home Health (NQF #0173)
measure with the Home Health Within Stay Potentially Preventable
measure and proposes to publicly report the Percent of Residents
Experiencing One or More Major Falls with Injury measure and
Application of Percent of Long-Term Care Hospital Patients with an
Admission and Discharge Functional Assessment and a Care Plan that
Addresses Function (NQF #2631) measure beginning in April 2022.
Finally, this proposed rule proposes revisions for certain HHA QRP
reporting requirements. This proposed rule would also revise similar
compliance dates for certain IRF QRP and LTCH QRP requirements.
4. Proposed Changes to the Home Health Conditions of Participation
In this rule, we propose to make permanent selected regulatory
blanket waivers related to home health aide
[[Page 35876]]
supervision that were issued to Medicare participating home health
agencies during the COVID-19 PHE. In addition, Division CC, section 115
of CAA 2021 requires CMS to permit an occupational therapist to conduct
a home health initial assessment visit and complete a comprehensive
assessment under the Medicare program, but only when occupational
therapy is on the home health plan of care, with either physical
therapy or speech therapy, and when skilled nursing services are not
initially in the plan of care.
We are proposing changes to the home health aide supervision
requirements at Sec. 484.80(h)(1) and Sec. 484.80(h)(2) and
conforming regulation text changes at Sec. 484.55(a)(2) and (b)(3),
respectively, to allow occupational therapists to complete the initial
and comprehensive assessments for patients in accordance with changes
in the law.
5. Medicare Coverage of Home Infusion Therapy
This proposed rule includes updates to the home infusion therapy
services payment rates for CY 2022, as required by section 1834(u) of
the Act.
6. Provider and Supplier Enrollment Processes
In section VI. of this proposed rule, we address a number of
provisions regarding Medicare provider and supplier enrollment. Most of
these provisions involve the incorporation into 42 CFR part 424,
subpart P of certain subregulatory policies. These are addressed in
section VI.B. of this proposed rule and include, for example, policies
related to: (1) The effective date of billing privileges for certain
provider and supplier types and certain provider enrollment
transactions; and (2) the deactivation of a provider or supplier's
billing privileges.
In addition, we propose in section VI.C. of this proposed rule two
regulatory clarifications related to HHA changes of ownership and HHA
capitalization requirements.
7. Survey and Enforcement Requirements for Hospice Programs
In this proposed rule, CMS seeks to increase and improve
transparency, oversight, and enforcement for hospice programs in
addition to implementing the provisions of Division CC, section 407(b)
of CAA 2021. CMS continues to review and revise our health and safety
requirements and survey processes to ensure that they are effective in
driving quality of care for hospice programs.
B. Summary of the Provisions of This Rule
1. Home Health Prospective Payment System (HH PPS)
In section II.B.1. of this rule, we provide data analyses on PDGM
utilization since implementation of the new payment system in CY 2020.
We describe a methodology for determining budget neutrality for CY 2020
and solicit comments on the difference between assumed versus actual
behavior change on estimated aggregate expenditures.
In section II.B.3. of this rule, we propose to recalibrate the PDGM
case-mix weights, functional levels, and comorbidity adjustment
subgroups while proposing to maintain the CY 2021 LUPA thresholds for
CY 2022. The PDGM relies on clinical characteristics and other patient
information to place patients into meaningful payment categories and
eliminates the use of therapy service thresholds, as required by
section 1895(b)(4)(B) of the Act, as amended by section 51001(a)(3) of
the Bipartisan Budget Act of 2018 (BBA of 2018).
In section II.B.4. of this rule, we propose to update the home
health wage index, the CY 2022 national, standardized 30-day period
payment amounts and the CY 2022 national per-visit payment amounts by
the home health payment update percentage. The home health payment
update percentage for CY 2022 is estimated to be 1.8 percent.
Additionally, this proposed rule proposes to update the FDL ratio to
0.41 for CY 2022.
In section II.B.4.(c).(5). of this proposed rule, we discuss the
regulations under Division CC, section 115 of CAA 2021 that revised
Sec. Sec. 484.55(a)(2) and 484.55(b)(3) to allow occupational
therapists (OTs) to conduct initial and comprehensive assessments for
all Medicare beneficiaries under the home health benefit when the plan
of care does not initially include skilled nursing care. We propose to
utilize the physical therapy (PT) LUPA add-on factor to establish the
OT add-on factor for the LUPA add-on payment amounts.
In section II.B.6. of this proposed rule, we are proposing
conforming regulations text changes at Sec. 409.43 to reflect that
allowed practitioners, in addition to physicians, may establish and
periodically review the home health plan of care in accordance with
section 3708 of the Coronavirus Aid, Relief, and Economic Security Act
(CARES Act) (Pub. L. 116-136, March 27, 2020).
2. Home Health Value Based Purchasing (HHVBP) Model
In section III.A. of this proposed rule, we are proposing to expand
the HHVBP Model to all Medicare-certified HHAs in the 50 States,
territories, and District of Columbia beginning January 1, 2022 with CY
2022 as the first performance year and CY 2024 as the first payment
year, with a proposed maximum payment adjustment, upward or downward,
of 5-percent. We propose that the expanded Model would generally use
benchmarks, achievement thresholds, and improvement thresholds based on
CY 2019 data to assess achievement or improvement of HHA performance on
applicable quality measures and that HHAs would compete nationally in
their applicable size cohort, smaller-volume HHAs or larger-volume
HHAs, as defined by the number of complete unique beneficiary episodes
for each HHA in the year prior to the performance year. All HHAs
certified to participate in the Medicare program prior to January 1,
2021 would be required to participate and eligible to receive an annual
Total Performance Score based on their CY 2022 performance. We propose
the applicable measure set for the expanded Model, as well as policies
related to the removal, modification, and suspension of quality
measures, and the addition of new measures and the form, manner and
timing of the OASIS-based, HHCAHPS survey-based, and claims-based
measures submission in the proposed applicable measure set beginning CY
2022 and subsequent years. We also include proposals for an appeals
process, an extraordinary circumstances exception policy, and public
reporting of annual performance data under the expanded Model.
In section III.B. of this proposed rule, we propose to end the
original HHVBP Model one year early. We propose that we would not use
CY 2020 performance data for the HHAs in the nine original Model States
to apply payment adjustments for the CY 2022 payment year. We also
propose that we would not publicly report CY 2020 (performance year 5)
annual performance data under the original HHVBP Model.
3. HH QRP
In section IV.C. of this proposed rule, we propose updates to the
HH QRP including: The removal of one 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
[[Page 35877]]
requirements for certain HH QRP reporting requirements and requests for
information regarding digital quality measures and health equity.
4. Proposed Changes to the Home Health Conditions of Participation
In section IV.D. of this rule, we propose to make permanent
selected regulatory blanket waivers related to home health aide
supervision that were issued to Medicare participating home health
agencies during the COVID-19 PHE. In addition, Division CC, section 115
of CAA 2021 requires CMS to permit an occupational therapist to conduct
the initial assessment visit and complete the comprehensive assessment
under the Medicare program, but only when occupational therapy is on
the home health plan of care with either physical therapy or speech
therapy and skilled nursing services are not initially on the plan of
care. We are proposing changes to the home health aide supervision
requirements at Sec. 484.80(h)(1) and (h)(2) and we are proposing
conforming regulation text changes at Sec. 484.55(a)(2) and (b)(3),
respectively to allow occupational therapists completing the initial
and comprehensive assessments for patients
5. Medicare Coverage of Home Infusion Therapy
In section V.A.1. of this proposed rule, we discuss the home
infusion therapy services payment categories, as finalized in the CYs
2019 and 2020 HH PPS final rules with comment period (83 FR 56406, 84
FR 60611). In section V.A.2. of this proposed rule, we discuss the home
infusion therapy services payment adjustments including a proposal to
update the GAFs used for wage adjustment and a proposal to maintain the
percentages finalized for the initial and subsequent visit policy. In
section V.A.3. of this proposed rule, we discuss updates to the home
infusion therapy services payment rates for CY 2022, as required by
section 1834(u) of the Act.
6. Provider and Supplier Enrollment Processes
In section VI. of this proposed rule, we address a number of
provisions regarding Medicare provider and supplier enrollment. Most of
these provisions involve the incorporation into 42 CFR part 424,
subpart P of certain subregulatory policies. These are addressed in
section VI.B. of this proposed rule and include, for example, policies
related to: (1) The effective date of billing privileges for certain
provider and supplier types and certain provider enrollment
transactions; and (2) the deactivation of a provider or supplier's
billing privileges.
In addition, we propose in section VI.C. of this proposed rule two
regulatory clarifications related to HHA changes of ownership and HHA
capitalization requirements.
7. Survey and Enforcement Requirements for Hospice Programs
In section VII. of this proposed rule, there are a number of
provisions related to Division CC, section 407 of CAA 2021. These
proposed provisions enhance the hospice program survey process by
requiring the use of multidisciplinary survey teams, prohibiting
surveyor conflicts of interest, expanding CMS-based surveyor training
to accrediting organizations (AOs), and requiring AOs with CMS-approved
hospice programs to begin use of the Form CMS-2567. Additionally, the
proposed provisions establish a hospice program complaint hotline.
Finally, the proposed provisions create a Special Focus Program (SFP)
for poor-performing hospice programs and the authority for imposing
enforcement remedies for noncompliant hospice programs including the
development and implementation of a range of remedies as well as
procedures for appealing determinations regarding these remedies.
Section 1865(a) of the Act provides that CMS may recognize and
approve national AO Medicare accreditation programs which demonstrate
that their health and safety standards and survey and oversight
processes meet or exceed those used by CMS to determine compliance with
applicable requirements. The CAA 2021 provisions expanding requirements
for AOs will apply to AOs that accredit and ``deem'' hospice programs,
and currently there are three such AOs: Accreditation Commission for
Health Care (ACHC), Community Health Accreditation Partner (CHAP), and
The Joint Commission (TJC). Half of all the Medicare-certified hospices
have been deemed by these AOs.
We describe and solicit comments on all aspects of these proposed
survey and enforcement provisions for hospice programs.
8. Inpatient Rehabilitation Facility Quality Reporting Program
In section IX.A. of this proposed rule, we propose to modify the
compliance date for certain reporting requirements in the IRF QRP.
9. Long Term Care Hospital Quality Reporting Program
In section IX.B. of this proposed rule, we propose to modify the
compliance date for certain reporting requirements in the -LTCH QRP.
C. Summary of Costs, Transfers, and Benefits
BILLING CODE 4120-01-P
[[Page 35878]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.000
BILLING CODE 4120-01-C
II. Home Health Prospective Payment System
A. Overview of the Home Health Prospective Payment System
1. Statutory Background
Section 1895(b)(1) of the Act requires the Secretary to establish a
Home Health Prospective Payment System (HH PPS) for all costs of home
health services paid under Medicare. Section 1895(b)(2) of the Act
required that, in defining a prospective payment amount, the Secretary
will consider an appropriate unit of service and the number, type, and
duration of visits provided within that unit, potential changes in the
mix of services provided within that unit and their cost, and a general
system design that provides for continued access to quality services.
In accordance with the statute, as amended by the Balanced Budget
Act of 1997 (BBA), (Pub. L. 105-33, enacted August 5, 1997) we
published a final rule in the July 3, 2000 Federal Register (65 FR
41128) to implement the HH PPS legislation. Section 4603(a) of the BBA
allowed the Secretary to consider an appropriate unit of service and at
such time, a 60-day unit of payment was established. The July 2000
final rule established requirements for the new HH PPS for home health
services as required by section 4603 of the BBA, as subsequently
amended by section 5101 of the Omnibus Consolidated and Emergency
Supplemental Appropriations Act for Fiscal Year 1999 (OCESAA) (Pub. L.
105-277, enacted October 21, 1998); and by sections 302, 305, and 306
of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999, (BBRA) (Pub. L. 106-113,
[[Page 35879]]
enacted November 29, 1999). For a complete and full description of the
HH PPS as required by the BBA, see the July 2000 HH PPS final rule (65
FR 41128 through 41214).
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v)
to the Act, requiring home health agencies (HHAs) to submit data for
purposes of measuring health care quality, and linking the quality data
submission to the annual applicable payment percentage increase. This
data submission requirement is applicable for CY 2007 and each
subsequent year. If an HHA does not submit quality data, the home
health market basket percentage increase is reduced by 2 percentage
points. In the November 9, 2006 Federal Register (71 FR 65935), we
published a final rule to implement the pay-for-reporting requirement
of the DRA, which was codified at 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, 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
[[Page 35880]]
services. Medicare also adjusts the national standardized 30-day period
payment rate for certain intervening events that are subject to a
partial payment adjustment (PEP). For certain cases that exceed a
specific cost threshold, an outlier adjustment may also be available.
Under this case-mix methodology, case-mix weights are generated for
each of the different PDGM payment groups by regressing resource use
for each of the five categories (admission source, timing clinical
grouping, functional impairment level, and comorbidity adjustment)
using a fixed effects model. A detailed description of each of the
case-mix variables under the PDGM have been described previously, and
we refer readers to the CY 2021 HH PPS final rule (85 FR 70303 through
70305).
[GRAPHIC] [TIFF OMITTED] TP07JY21.001
B. Proposed Provisions for Payment Under the HH PPS
1. Monitoring the Effects of the Implementation of PDGM
a. Background
The PDGM made several changes to the HH PPS, including replacing
60-day episodes of care with 30-day periods of care, removing therapy
volume from directly determining payment, and developing 432 case-mix
adjusted payment groups in place of the previous 153 groups. In the CY
2020 HH PPS final rule with comment period (84 FR 60513), we stated
that continued monitoring is needed to understand how the PDGM,
including the variables that determine the case-mix weights, affects
the provision of home health care in order to inform any future
refinements, if needed.
CMS recognizes it takes time for HHAs to operationalize and adjust
to a new payment system. We believe these adjustments are still
occurring and HHAs are still adjusting to the new payment system given
that these changes are the most significant changes to the HH PPS since
its inception in
[[Page 35881]]
2000. Additionally, the COVID-19 PHE was declared on January 31, 2020
and was retroactive to January 27, 2020.\1\ Therefore, any emerging
trends may or may not be temporary, permanent, or unrelated to the
implementation of the PDGM. Nevertheless, we understand stakeholders
want to learn about how home health utilization patterns may have
changed under the PDGM, so we are providing preliminary information in
this proposed rule.
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\1\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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b. Claims Data Overview Used in PDGM Monitoring
We believe using actual claims data, whenever possible, will
provide the most comprehensive and complete evaluation of changes
before and after implementation of the PDGM. Prior to the PDGM, HHAs
were paid a case-mix adjusted payment for 60-day episodes of care using
one of the 153 HHRGs with various therapy utilization thresholds. Under
the PDGM, HHAs are paid a case-mix adjusted payment for 30-day periods
of care using one of the 432 HHRGs that do not include therapy
thresholds. For our analysis, we used the analytic file described in
the CY 2020 HH PPS final rule with comment period (84 FR 60512) and
applied the three behavioral assumptions to only half of the 30-day
periods of care (randomly selected). That is, we used the CY 2018 home
health data to divide one 60-day episode of care into two simulated 30-
day periods of care that were used to set payment rates in the CY 2020
HH PPS final rule with comment period (84 FR 60518). We also used the
analytic file described in the CY 2021 HH PPS final rule (85 FR 70298)
and applied the three behavioral assumptions to only half of the 30-day
periods of care (randomly selected). That is, we used the CY 2019 home
health data to divide one 60-day episode of care into two simulated 30-
day periods of care that we used to for routine rate-setting updates
and changes for CY 2021. The simulated data in these analytical files
represent pre-PDGM utilization. We refer readers to the CY 2019 HH PPS
proposed rule (83 FR 32382 through 32388) for a detailed description of
how these analytical files were created. Finally, we used CY 2020
claims data as of March 30, 2021 to analyze utilization changes post-
implementation of the PDGM and 30-day unit of payment.
c. Routine PDGM Monitoring
As noted previously, section 1895(b)(3)(D) of the Act requires CMS
to annually determine the impact of assumed versus actual behavior
changes on aggregate expenditures under the HH PPS for CYs 2020 through
2026. Analyses for routine monitoring may include, but would not be
limited to, analyzing: Overall total 30-day periods of care and average
periods of care per HHA user; the distribution of visits in a 30-day
period of care; the percentage of periods that receive the low-
utilization payment adjustment (LUPA); the percentage of 30-day periods
of care by clinical group, comorbidity adjustment, admission source,
timing, and functional impairment level; and the proportion of 30-day
periods of care with and without any therapy visits. As a reminder, the
beginning of CY 2020 included ongoing 60-day episodes of care that
began in CY 2019 and ended in CY 2020. Depending on the length of the
remainder of the episode, those 60-day episodes were simulated into one
or two 30-day periods of care and are included in this year's proposed
rule monitoring tables. Approximately, 6.1 percent of the 30-day
periods of care in CY 2020 data were simulated because the original 60-
day episode of care began in CY 2019 and ended in CY 2020. We remind
readers, our preliminary analysis described in this section is not tied
to any quality program.
(1) Utilization
We evaluate utilization by comparing our simulated 30-day periods
in our analytical files, to actual CY 2020 PDGM claims, as described
previously. The analytic files used for annual ratesetting do not
include all 60-day episodes or 30-day periods of care because some of
these episodes/periods are dropped for various reasons (for example,
the claim could not be matched to an OASIS assessment). For all of the
tables that follow, we examined utilization for CY 2018 simulated 30-
day periods of care, CY 2019 simulated 30-day periods of care, and CY
2020 actual 30-day periods of care. Table 2 shows the overall
utilization of home health over time. Table 3 shows utilization of
visits per 30-day period of care by home health discipline over time.
Preliminary data indicates while the number of 30-day periods of care
decreased between CY 2018 and CY 2020, the average number of 30-day
periods of care per unique HHA user is similar. Additionally, our
preliminary data indicates, on average, the number of visits per 30-day
period of care for all disciplines decreased between CY 2018 and CY
2020. On average, the total number of visits decreased by 1.27 visits
per 30-day period of care between CY 2018 and CY 2020. Table 4 shows
the proportion of 30-day periods of care that are LUPAs and the average
number of visits per discipline of those LUPA 30-day periods of care
over time.
BILLING CODE 4120-01-P
[[Page 35882]]
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[GRAPHIC] [TIFF OMITTED] TP07JY21.003
[[Page 35883]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.004
BILLING CODE 4120-01-C
(2) Analysis of 2019 Cost Report Data for 30-Day Periods of Care
In the CY 2020 HH PPS final rule with comment period (84 FR 60483),
we provided a summary of analysis on fiscal year (FY) 2017 HHA cost
report data and how such data, if used, would impact our estimate of
the percentage difference between Medicare payments; the CY 2020 30-day
payment amount and estimated, average HHA costs for a 30-day period of
care. In that rule, we utilized FY 2017 cost reports and CY 2017 home
health claims to estimate both 60-day episode of care and 30-day period
of care costs. We then updated the estimated CY 2017 60-day episode
costs and 30-day period of care costs by the home health market basket
update, reduced by the productivity adjustment for CYs 2018, 2019 and
2020 to calculate the 2020 estimated 60-day episode and 30-day period
of care costs. As stated in the CY 2020 HH PPS final rule with comment
period (84 FR 60485), we estimated that the CY 2020 30-day payment
amount was approximately 16 percent higher than the average costs for a
30-day period of care. In MedPAC's March 2020 Report to Congress,\2\
their review of home health payment adequacy found that ``access is
more than adequate in most areas and that Medicare payments are
substantially in excess of costs''.
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\2\ http://www.medpac.gov/docs/default-source/reports/mar20_medpac_ch9_sec.pdf?sfvrsn=0.
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In this proposed rule, we examined 2019 HHA Medicare cost reports,
as this is the most recent and complete cost report data at the time of
rulemaking, and CY 2020 30-day period of care home health claims, to
estimate 30-day period of care costs. We excluded LUPAs and PEPs in the
average number of visits. The 2019 average NRS costs per visit is
$3.94. We updated the estimated 30-day period of care costs, 2019
average costs per visit with NRS by the CY 2020 home health market
basket update, reduced by the productivity adjustment of 2.6 percent.
Table 5 shows the estimated average costs for 30-day periods of care by
discipline with NRS and the total 30-day period of care costs with NRS
for CY 2020.
[[Page 35884]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.005
The CY 2020 national, standardized 30-day period payment rate was
$1,864.03, which is approximately 34 percent more than the estimated CY
2020 30-day period cost of $1,394.68. Note that in the CY 2020 HH PPS
final rule with comment period (84 FR 60484), the estimated average
number of visits for a 30-day period of care in 2017 was estimated to
be 10.5 visits. Using actual CY 2020 claims data, the average number of
visits in a 30-day period was 9.25 visits--a decrease of approximately
12 percent. We recognize that with the COVID-19 PHE, the 2019 data on
the Medicare cost reports may not reflect the most recent changes such
as increased telecommunications technology costs, increased personal
protective equipment (PPE) costs, and hazard pay. In its March 2021
Report to Congress, to estimate Medicare margins for 2021, MedPAC
assumed a cost growth of 3 percent for CY 2020 (2 percentage points due
to inflation and higher expenses for PPE and telehealth and 1
percentage point due to temporary surge pricing for PPE and other
temporary costs of the PHE).\3\ Furthermore, MedPAC noted that for more
than a decade, payments under the HH PPS have significantly exceeded
HHAs' costs primarily due to two factors--agencies reducing visits to
reduce episode costs and cost growth in recent years has been lower
than the annual payment updates.\4\ As shown in Table 3 in this
proposed rule, HHAs have reduced visits under the PDGM in CY 2020. When
the 2020 cost reports become available, we will update the estimated
30-day period of care costs in CY 2020 in future rulemaking.
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\3\ http://www.medpac.gov/docs/default-source/reports/mar21_medpac_report_to_the_congress_sec.pdf?sfvrsn=0.
\4\ Ibid.
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(3) Clinical Groupings and Comorbidities
Each 30-day period of care is grouped into one of 12 clinical
groups, which describe the primary reason for which patients are
receiving home health services under the Medicare home health benefit.
The clinical grouping is based on the principal diagnosis reported on
the home health claim. Table 6 shows the distribution of the 12
clinical groups over time. We also include the average case-mix weight
for all 30-day periods in each of the clinical groups in CY 2020. In
other words, the average case-mix weight for each clinical group
includes all possible comorbidity adjustments, admission source and
timing, and functional impairment levels. We refer readers to Table 16
in the CY 2020 HH PPS final rule with comment period (84 FR 60522
through 60533) for the CY 2020 PDGM LUPA threshold and case mix weight
for each HHRG payment group.
[[Page 35885]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.006
Thirty-day periods will receive a comorbidity adjustment category
based on the presence of certain secondary diagnoses reported on home
health claims. These diagnoses are based on a home health specific list
of clinically and statistically significant secondary diagnosis
subgroups with similar resource use. We refer readers to section II. of
this proposed rule and the CY 2020 final rule with comment period (84
FR 60493) for further information on the categories of the comorbidity
adjustment. Home health 30-day periods of care can receive a low or a
high comorbidity adjustment, or no comorbidity adjustment. Table 7
shows the distribution of 30-day periods of care by comorbidity
adjustment category for all 30-day periods. We also include the average
case-mix weight for each of the comorbidity adjustments in CY 2020. In
other words, the average case-mix weight for each comorbidity
adjustment includes all possible clinical groupings, admission source
and timing, and functional impairment levels.
[GRAPHIC] [TIFF OMITTED] TP07JY21.007
(4) Admission Source and Timing
Each 30-day period of care is classified into one of two admission
source categories--community or institutional--depending on what
healthcare setting was utilized in the 14 days prior to receiving home
health care. Thirty-day periods of care for beneficiaries with any
inpatient acute care hospitalizations, inpatient psychiatric facility
(IPF) stays, skilled nursing facility (SNF) stays, inpatient
rehabilitation facility (IRF) stays, or long-term care hospital (LTCH)
stays within 14 days prior to a home health admission are designated as
institutional admissions. Thirty-day periods of care are classified as
``early'' or ``late'' depending on when they occur within a sequence of
30-day periods of care. The first 30-day period of care is classified
as early and all subsequent 30-day periods of care in the sequence
(second or later) are classified as late. A subsequent 30-day period of
care would not be considered early unless there is
[[Page 35886]]
a gap of more than 60 days between the end of one previous period of
care and the start of another. Information regarding the timing of a
30-day period of care comes from Medicare home health claims data and
not the OASIS assessment to determine if a 30-day period of care is
``early'' or ``late''. Table 8 shows the distribution of 30-day periods
of care by admission source and timing over time. We also include the
average case-mix weight for each of the admission source and period
timing in CY 2020. In other words, the average case-mix weight for each
admission source and period timing includes all possible clinical
groupings, comorbidity adjustment, and functional impairment levels. We
refer readers to Table 16 in the CY 2020 HH PPS Final Rule with comment
period (84 FR 60522 through 60533) for the CY 2020 PDGM LUPA threshold
and case mix weight for each HHRG payment group.
[GRAPHIC] [TIFF OMITTED] TP07JY21.008
(5) Functional Impairment Level
Each 30-day period of care is placed into one of three functional
impairment levels (low, medium, or high) based on responses to certain
OASIS functional items associated with grooming, bathing, dressing,
ambulating, transferring, and risk for hospitalization. The specific
OASIS items that are used for the functional impairment level are found
in Table 7 in the CY 2020 HH PPS final rule with comment period (84 FR,
60490). Responses to these OASIS items are grouped together into
response categories with similar resource use and each response
category has associated points. A more detailed description as to how
these response categories were established can be found in the
technical report, ``Overview of the Home Health Groupings Model''
posted on the HHA web page.\5\ The sum of these points' results in a
functional impairment level score used to group 30-day periods of care
into a functional impairment level with similar resource use. The
scores associated with the functional impairment levels vary by
clinical group to account for differences in resource utilization. The
functional impairment level will remain the same for the first and
second 30-day periods of care unless there has been a significant
change in condition which that warranted an ``other follow-up''
assessment prior to the second 30-day period of care. For each 30-day
period of care, the Medicare claims processing system will look for the
most recent OASIS assessment based on the claims ``from date.'' Table 9
shows the distribution of 30-day periods by functional status. We also
include the average case-mix weight for each functional impairment
level in CY 2020. In other words, the average case-mix weight for each
functional impairment level includes all possible clinical groupings,
comorbidity adjustment, and admission source and period timing. We
refer readers to Table 16 in the CY 2020 HH PPS Final Rule with comment
period (84 FR 60522 through 60533) for the CY 2020 PDGM LUPA threshold
and case mix weight for each HHRG payment group.
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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.
[GRAPHIC] [TIFF OMITTED] TP07JY21.009
[[Page 35887]]
Currently, the functional impairment level is determined by
responses to certain OASIS items associated with functional activities
of daily living and risk of hospitalization; that is, responses to
OASIS items M1800-M1860 and M1032. However, the Improving Medicare
Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-
185, enacted on October 6, 2014) amended Title XVIII of the Act to
include enacting new data reporting requirements for certain post-acute
care (PAC) providers, including HHAs. Sections 1899B(b)(1)(A) of the
Act requires the Secretary to require home health agencies to report
standardized patient assessment data beginning no later than January 1,
2019. The standardized patient assessment data categories include
functional status, such as mobility and self-care at admission and
discharge, in accordance with 1899B(b)(1)(B)(i) of the Act. As such,
CMS finalized adding the functional items, Section GG, ``Functional
Abilities and Goals'', to the OASIS data set, effective January 1,
2019, in order to be able to measure functional status across PAC
providers. At the time of CY 2020 rulemaking, we did not yet have the
data to determine the effect, if any, of these newly added items on
resource costs utilization during a home health period of care for use
in the PDGM. Therefore, the GG functional items are not currently used
to determine the functional impairment level under the PDGM.
We have examined the correlation between the current functional
items used for payment (that is, M1800-1860) and the analogous GG
items. We note that M1032, Risk for Hospitalization, does not have a
corresponding GG item. Our preliminary analysis shows there is a
correlation between the current responses to the M1800-1860 items and
the GG items. However, there are certain information in M1800 items
that are being collected at follow-up that are not collected with GG
items (for example, the M1800 items associated with upper and lower
body dressing are collected at follow up). Additionally, the GG items
include an ``Activity Not Attempted'' (ANA) option, meaning the
clinician did not put a response for the patient. Furthermore, there
are a variety of ANA responses, including ``Not attempted due to
medical or safety concerns'', and ``Not applicable''. Figure 2 shows
the frequencies by response type in CY 2020 to the OASIS GG items.
[GRAPHIC] [TIFF OMITTED] TP07JY21.010
Our analysis of the GG items shows a significant amount of these
ANA responses, making it difficult to map to the corresponding M1800-
1860 item responses. Therefore, we will continue to monitor the GG
items to determine the correlation between the current functional items
used to case-mix adjust home health payments and the GG items, and we
will provide additional analysis of the GG functional items in future
rulemaking.
(6) Therapy Visits
Beginning in CY 2020, section 1895(b)(4)(B)(ii) of the Act
eliminated the use of therapy thresholds in calculating payments for CY
2020 and subsequent years. Prior to implementation of the PDGM, HHAs
could receive an adjustment to payment based on the number of therapy
visits provided during a 60-day episode of care. As such, we examined
the proportion of simulated 30-day periods with and without any therapy
visits for CYs 2018 and 2019, prior to the removal of therapy
thresholds. We also examined the proportion of actual 30-day periods of
care with and without therapy visits for CY 2020, after the removal of
therapy thresholds. To be
[[Page 35888]]
covered as skilled therapy, the services must require the skills of a
qualified therapist (that is, PT, OT, or SLP) or qualified therapist
assistant and must be reasonable and necessary for the treatment of the
patient's illness or injury.\6\ As shown in Table 3, we are monitoring
the number of visits per 30-day periods of care by each home health
discipline. Any 30-day period of care can include both therapy and non-
therapy visits. If any 30-day period of care consisted of only visits
for PT, OT, and/or SLP, then this 30-day period of care is considered
``therapy only''. If any 30-day period of care consisted of only visits
for skilled nursing, home health aide, or social worker, then this 30-
day period of care is considered ``no therapy''. If any 30-day period
of care consisted of at least one therapy visit and one non-therapy,
then this 30-day period of care is considered ``therapy + non-
therapy''. Table 10 shows the proportion of 30-day periods of care with
only therapy visits, at least one therapy visit and one non-therapy
visits, and no therapy visits. Figure 3 shows the proportion of 30-day
periods of care by the number of therapy visits (excluding zero)
provided during 30-day periods of care.
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\6\ Medicare Benefit Policy Manual, Chapter 7 Home Health
Services, Section 40.2 Skilled Therapy Services https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
[GRAPHIC] [TIFF OMITTED] TP07JY21.011
[GRAPHIC] [TIFF OMITTED] TP07JY21.012
Both Table 10 and Figure 3, as previously discussed, indicate there
have been changes in the distribution of both therapy and non-therapy
visits in CY 2020. For example, the percent of 30-day periods with six
or less therapy
[[Page 35889]]
visits during a 30-day period increased in CY 2020. However, the
percent of 30-day periods with seven or more therapy visits decreased
in CY 2020.
In addition, we also examined the proportion of 30-day periods of
care with and without skilled nursing, social work, or home health aide
visits for CYs 2018, 2019 and 2020. Table 11 shows the number of 30-day
periods of care with only skilled nursing visits, at least one skilled
nursing visit and one other visit type (therapy or non-therapy), and no
skilled nursing visits. Table 13 shows the number of 30-day periods of
care with and without home health aide and/or social worker visits.
[GRAPHIC] [TIFF OMITTED] TP07JY21.013
[GRAPHIC] [TIFF OMITTED] TP07JY21.014
We will continue to monitor the provision of home health services,
including any changes in the number and duration of home health visits,
composition of the disciplines providing such services, and overall
home health payments to determine if refinements to the case-mix
adjustment methodology may be needed in the future.
We solicit public comments on the preliminary data analysis
presented in this rule and we solicit comments on whether there are
other analyses that should be conducted to examine the effects of the
PDGM on home health expenditures and utilization.
2. Comment Solicitation on the Annual Determination of the Impact of
Differences Between Assumed Behavior Changes and Actual Behavior
Changes on Estimated Aggregate Payment Expenditures Under the HH PPS
a. Background
Section 1895(b)(3)(A)(iv) of the Act, required CMS, with respect to
payments for home health units of service furnished that end during the
12-month period beginning January 1, 2020, to calculate a standard
prospective payment amount (or amounts) for 30-day units of service in
a manner such that the estimated aggregate amount of expenditures would
be equal to the estimated aggregate amount of expenditures that
otherwise would have been made had the 30-day unit of payment not been
enacted. In calculating such amount (or amounts), CMS was required to
make assumptions about behavior changes that could occur as a result of
the implementation of the 30-day unit of payment and the case-mix
adjustment factors that eliminated the use of therapy thresholds. CMS
was to provide a description of such assumptions through notice and
comment rulemaking.
In the CY 2019 HH PPS final rule with comment period (83 FR 56454),
as required by law, we stated that this means we were required to
calculate a 30-day period payment amount for CY 2020 in a budget
neutral manner such that estimated aggregate expenditures under the HH
PPS during CY 2020 were equal to the estimated aggregate expenditures
that otherwise would have been made under the HH PPS during CY 2020 in
the absence of the change to a 30-day unit of payment and the
implementation of the PDGM case-mix adjustment methodology. This means
[[Page 35890]]
that aggregate Medicare payments under the new 432-group payment system
and 30-day unit of payment would be the same as they would have been
under the 153-group payment system and 60-day unit of payment.
In the CY 2019 HH PPS final rule with comment period (83 FR 56455),
we finalized three behavior assumptions in order to calculate a 30-day
budget-neutral payment amount for CY 2020:
Clinical Group Coding: The clinical group is determined by
the principal diagnosis code for the patient as reported by the HHA on
the home health claim. This behavior assumption assumes that HHAs will
change their documentation and coding practices and put the highest
paying diagnosis code as the principal diagnosis code in order to have
a 30-day period be placed into a higher-paying clinical group.
Comorbidity Coding: The PDGM further adjusts payments
based on patients' secondary diagnoses as reported by the HHA on the
home health claim. The OASIS only allows HHAs to designate 1 principal
diagnosis and 5 secondary diagnoses while the home health claim allows
HHAs to designate 1 principal diagnosis and up to 24 secondary
diagnoses. This behavior assumption assumes that by taking into account
additional ICD-10-CM diagnosis codes listed on the home health claim
(beyond the 6 allowed on the OASIS), more 30-day periods of care will
receive a comorbidity adjustment.
LUPA Threshold: This behavior assumption assumes that for
one-third of LUPAs that are 1 to 2 visits away from the LUPA threshold
HHAs will provide 1 to 2 extra visits to receive a full 30-day payment.
There are overlaps and interactions between these behavior
assumptions, and when combined, the budget-neutral payment amount for
CY 2020 resulted in a proposed -8.389 percent adjustment to the 30-day
period payment amount compared to the payment amount calculated in a
budget neutral manner without these assumptions applied. In response to
the proposed rule, commenters stated that CMS overestimated the
magnitude of the assumed behavior changes. We reconsidered the
frequency of the assumed behaviors during the first year of the
transition to the new unit of payment and case-mix adjustment
methodology in response to these comments, and in the CY 2020 HH PPS
final rule with comment period (84 FR 60519), we finalized a -4.36
percent behavior assumption adjustment in order to calculate a
national, standardized 30-day base payment rate. After applying the
wage index budget neutrality factor and the home health payment update,
the CY 2020 30-day payment rate was set at $1,864.03, and for
determining outlier payments the fixed-dollar loss (FDL) ratio was set
at 0.56.
Section 1895(b)(3)(D)(i) of the Act requires CMS to annually
determine the impact of the differences between assumed behavior
changes and actual behavior changes on estimated aggregate expenditures
beginning with 2020 and ending with 2026. In the CY 2020 final rule (84
FR 60513), we stated that we interpret actual behavior changes to
encompass both behavior changes that were previously outlined, as
assumed by CMS, and other behavior changes not identified at the time
that the budget neutral 30-day payment for CY 2020 was determined. As
required by 1895(b)(3)(D)(ii) of the Act, the Secretary shall, at a
time and in a manner determined appropriate, through notice and comment
rulemaking, provide for one or more permanent increases or decreases to
the standard prospective payment amount (or amounts) for applicable
years, on a prospective basis, to offset for such increases or
decreases in estimated aggregate expenditures.
As required by section 1895(b)(3)(D)(iii) of the Act, the Secretary
shall, at a time and in a manner determined appropriate, through notice
and comment rulemaking, provide for one or more temporary increases or
decreases to the payment amount for a unit of home health services for
applicable years, on a prospective basis, to offset for such increases
or decreases in estimated aggregate expenditures. Such a temporary
increase or decrease shall apply only with respect to the year for
which such temporary increase or decrease is made, and the Secretary
shall not take into account such a temporary increase or decrease in
computing such amount for a subsequent year. That is, we are required
to retrospectively determine if the 30-day payment amount in CY 2020
resulted in the same level of estimated aggregate expenditures that
would have been made if the change in the unit of payment and the PDGM
case-mix adjustment methodology had not been implemented, and make
adjustments to the 30-day payment amount prospectively, if needed.
b. Methodology To Determine the Difference Between Assumed Versus
Actual Behavior Changes on Estimated Aggregate Expenditures
Using CY 2020 data (as of March 30, 2021), the most recent,
complete data available at the time of this proposed rule, we analyzed
the impact of the differences between assumed behavior changes and
actual behavior changes on estimated aggregate expenditures to
determine whether a temporary and/or a permanent increase or decrease
is needed to the national, standardized 30-day period payment in CY
2022. We analyzed data to determine if the CY 2020 30-day payment
amount resulted in the same estimated aggregate expenditures that would
have been paid if the PDGM and change in the unit of payment had not
been implemented.
To evaluate if whether the 30-day budget neutral payment amount for
CY 2020 maintained budget neutrality given the change to a 30-day unit
of payment and the implementation of a new case-mix adjustment
methodology without therapy thresholds was accurate, we used actual CY
2020 30-day period claims data to simulate 60-day episodes and we
determined what CY 2020 payments would have been under the 153-group
case-mix system and 60-day unit of payment. To do this, we used the
steps outlined as follows as detailed in this section of this rule.
The first step in repricing CY 2020 PDGM claims was to determine
which 30-day periods of care could be grouped together to form 60-day
episodes of care. To facilitate grouping, we made some exclusions and
assumptions.
(1) Exclusions
We limited the sample to 30-day periods where the claim occurrence
code 50 date (representing the OASIS assessment date) occurred on or
before October 31, 2020. This was done to ensure the simulated 60-day
episodes we constructed contained both 30-day periods and would not be
simulated 60-day episodes that would have overlapped into 2021.
We excluded the following:
Beneficiaries and all of their claims if they had
overlapping claims from the same provider (as identified by CCN).\7\
---------------------------------------------------------------------------
\7\ All of a beneficiary's claims were dropped so as not to
create problems with assigning episode timing if only a subset of
claims were dropped. 1,320 claims from 224 beneficiaries are
excluded.
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Beneficiaries and all of their claims if three or more
claims from the same provider are linked to the same occurrence code 50
date.\8\
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\8\ This was done because if three or more claims linked to the
same OASIS it would not be clear which claims should be joined to
simulate a 60-day episode. 11,794 claims from 351 beneficiaries are
excluded.
---------------------------------------------------------------------------
(2) Assumptions
We assumed the following:
If two 30-day periods of care from the same provider
reference the same
[[Page 35891]]
OASIS assessment date (using occurrence code 50), and then we assume
those two 30-day periods of care would have been billed as a 60-day
episode of care under the 153-group system.
If there are two 30 day-periods of care that reference
different OASIS assessment dates and each of those assessment dates is
referenced by a single 30-day period of care and those two 30-day
periods of care occur together close in time (that is, the from date of
the later 30-day period of care is between 0 to 14 days after the
through date of the earlier 30-day period of care), then we assume
those two 30-day periods of care also would have been billed as a 60-
day episode of care under the 153-group system.
For all other 30-day periods of care, we assumed that they
would not be combined with another 30-day period of care and would have
been billed alone. We excluded such periods that occurred at the start
of the year (January 1, 2020-January 14, 2020) or end of the year
(December 1-31, 2020) so as not to count a single 30-day period of care
that may have had a counterpart that could not be observed.
Once we applied our exclusions and assumptions, we assigned each
60-day episode of care as a normal episode, PEP, LUPA, or outlier based
on the payment parameters established in the CY 2020 final rule with
comment period (84 FR 60478) for 60-day episodes of care. Next, using
the 3M Home Health Grouper (v8219) we assigned a Health Insurance
Prospective Payment System (HIPPS) code to each simulated 60-day
episode of care using the 153-group methodology. Finally, we priced out
the simulated 60-day episodes of care using the payment parameters
described in the CY 2020 final rule with comment period (84 FR 60537)
for 60-day episodes of care. Before comparing payments for the 30-day
periods of care using the 432-group PDGM methodology, we first removed
any claim that was excluded in the simulated 60-day episode dataset.
Therefore, our comparison between payments had the same utilization
between the CY 2020 simulated 60-day episodes of care and the CY 2020
actual 30-day periods of care.
We began with 8,165,808 30-day periods of care and dropped 524,163
30-day periods of care that had a claim occurrence code 50 date after
October 31, 2020. We also eliminated 81,641 30-day periods of care that
appeared to not group with another 30-day period of care to form a 60-
day episode of care if the 30-day period of care had a ``from date''
before January 15, 2020 or a ``through date after'' November 30, 2020.
This was done to ensure the 30-day period of care would not have been
part of a 60-day episode of care that would have spanned into a prior
or subsequent year. As described previously, we excluded claims and
made assumptions when combining two 30-day periods of care.
Additionally, any simulated 60-day episode of care where no OASIS
information was available or could not be grouped to a HIPPS due to a
missing primary diagnosis or other reason was excluded from analysis.
Our simulated 60-day episodes of care produced a distribution between
two 30-day periods of care (69.8 percent) and single 30-day periods of
care (30.2 percent) that was similar to what we found when we simulated
two 30-day periods of care for implementation of the PDGM. After all
exclusions and assumptions were applied, the final dataset included
7,441,602 actual 30-day periods of care and 4,378,823 simulated 60-day
episodes of care for CY 2020.
For the simulated 60-day episodes of care and before any adjustment
for PEP, LUPA, or outliers were applied, payments were calculated using
the CY 2020 153-group 60-day base payment rate of $3,220.79, the 153-
group case-mix adjustment methodology, and FDL of 0.51, as described in
the CY 2020 HH PPS final rule with comment period (84 FR 60537). For
the actual 30-day periods of care that constructed the simulated 60-day
episodes of care and before any adjustment for PEP, LUPA, or outliers
were applied, payments were calculated using the CY 2020 30-day base
payment rate of $1,864.03, the 432-group PDGM case-mix adjustment
methodology, and FDL of 0.56 as described in the CY 2020 final rule
with comment period (84 FR 60539). After the claims in the simulated
60-day episodes of care and 30-day periods of care were priced using
the payment rates described previously, we calculated the total
payments for all periods, normal periods, PEPs, LUPAs, and outliers
(excluding the base payment to ensure outlier payments were no more
than 2.5 percent of total estimated HH PPS payments). Our preliminary
results indicated that aggregate payments to HHAs were higher in CY
2020 under the PDGM case-mix adjustment methodology and the 30-day unit
of payment compared to what HHAs would have been paid had the PDGM and
30-day unit of payment not been implemented.
Next, we calculated what the CY 2020 30-day periods of care base
payment rate and FDL should have been, to achieve the estimated
aggregate payments for the simulated 60-day episodes in CY 2020. We
then calculated a percent change between the payment rates. In other
words, we divided the CY 2020 repriced 30-day base payment rate by the
actual CY 2020 base-payment rate minus one. We determined the CY 2020
30-day base payment rate was approximately 6 percent higher than it
should have been, and would require temporary retrospective adjustments
for CY 2020 and subsequent years until a permanent prospective
adjustment could be implemented in future rulemaking.
One of the driving factors between what we paid HHAs under the
current 432-group PDGM methodology with a 30-day unit of payment and
what we would have paid HHAs under the previous 153-group case-mix
adjustment methodology with a 60-day unit of payment is related to the
average case-mix weights. The average case-mix weight for the 30-day
periods of care used to construct the simulated 60-day of care episodes
was 1.0310; compared to the average case-mix weight for the simulated
60-day of care episodes was 0.9657, a difference of 0.0653. As the
difference between the two average case-mix weights increases (that is,
farther from zero) the higher the difference in payments; conversely as
the difference between the two average case-mix weights decreases (that
is, closer to zero) the smaller the difference in payments. HHAs should
be providing visits in accordance with patient care needs.
The law provides flexibility for the Secretary to make an increase
or decrease adjustment to the 30-day payment amount to offset any
difference between assumed versus actual behavior of estimated
aggregate expenditures, at a time and manner determined appropriate and
allows for prospective adjustments based on retrospective behavior. As
stated previously, currently our preliminary analysis shows an
additional payment decrease would more appropriately account for
behaviors reflected in CY 2020, after the implementation of the PDGM
and 30-day unit of payment. However, we anticipate potentially seeing
further variability in this percentage as we continue to analyze full
claims data from CY 2020 and subsequent years, and considering that the
COVID-19 PHE is still ongoing. We intend to propose a methodology and,
if appropriate, a temporary and permanent payment adjustment based on
our analysis in future rulemaking. However, we note that by not
proposing any adjustment for CY 2022, this could potentially result in
larger, compounding payment adjustments in future years to fully
[[Page 35892]]
account for the difference between assumed versus actual behavior
change on estimated aggregate expenditures beginning in CY 2020.
We recognize that stakeholders may have other ways to analyze the
data to determine the difference between assumed versus actual behavior
change on estimated aggregate expenditures, such as analysis of nominal
case-mix growth or calculating the percent difference and percent
change of payments between simulated 30-day periods of care and actual
30-day periods of care. We solicit comments on the described repricing
method for evaluating budget neutrality for CY 2020 and any alternate
approaches to annually determine the difference between assumed and
actual behavioral changes on estimated aggregate expenditures under the
HH PPS.
3. CY 2022 PDGM LUPA Thresholds and PDGM Case-Mix Weights
a. Proposed CY 2022 PDGM LUPA Thresholds
Under the HH PPS, LUPAs are paid when a certain visit threshold for
a payment group during a 30-day period of care is not met. In the CY
2019 HH PPS final rule (83 FR 56492),) we finalized that the LUPA
thresholds would be set at the 10th percentile of visits or 2 visits,
whichever is higher, for each payment group. This means that the LUPA
threshold for each 30-day period of care varies depending on the PDGM
payment group to which it is assigned. If the LUPA threshold for the
payment group is met under the PDGM, the 30-day period of care will be
paid the full 30-day period case-mix adjusted payment amount (subject
to any PEP or outlier adjustments). If a 30-day period of care does not
meet the PDGM LUPA visit threshold, then payment will be made using the
CY 2022 per-visit payment amounts as described in Section III of this
proposed rule. For example, if the LUPA visit threshold is four, and a
30-day period of care has four or more visits, it is paid the full 30-
day period payment amount; if the period of care has three or less
visits, payment is made using the per-visit payment amounts.
In the CY 2019 HH PPS final rule with comment period (83 FR 56492),
we finalized our policy that the LUPA thresholds for each PDGM payment
group would be reevaluated every year based on the most current
utilization data available at the time of rulemaking. However, CY 2020
was the first year of the new case-mix adjustment methodology and we
stated in the CY 2021 final rule (85 FR 70305, 70306) we would maintain
the LUPA thresholds that were finalized and shown in Table 17 of the CY
2020 HH PPS final rule with comment period (84 FR 60522) for CY 2021
payment purposes. At that time, we did not have sufficient CY 2020 data
to reevaluate the LUPA thresholds for CY 2021.
We have received anecdotal feedback from stakeholders that in CY
2020, HHAs billed more LUPAs because patients requested fewer in-person
visits due the COVID-19 PHE. As discussed further in this section of
this rule, while we are proposing to update the case-mix weights for CY
2022 using CY 2020 data, there are several factors that contribute to
how the case-mix weight is set for a particular case-mix group (such as
the number of visits, length of visits, types of disciplines providing
visits, and non-routine supplies) and the case-mix weight is derived by
comparing the average resource use for the case-mix group relative to
the average resource use across all groups. CMS believes that the PHE
would have impacted utilization within all case-mix groups similarly.
Therefore, the impact of any reduction in resource use caused by the
PHE on the calculation of the case-mix weight would be minimized since
the impact would be accounted for both in the numerator and denominator
of the formula used to calculate the case-mix weight. However, in
contrast, the LUPA thresholds are based on the number of overall visits
in a particular case-mix group (the threshold is the 10th percentile of
visits or 2 visits, whichever is greater) instead of a relative value
(like what is used to generate the case-mix weight) that would control
for the impacts of the PHE. We note that visit patterns and some of the
decrease in overall visits in CY 2020 may not be representative of
visit patterns in CY 2022. If we were to set the LUPA thresholds in
this proposed rule using CY 2020 data and then set the LUPA thresholds
again for CY 2023 using data from CY 2021, it is likely that there
would be an increase in these thresholds due to the lower number of
visits that occurred in CY 2020. Therefore, to mitigate any potential
future and significant short-term variability in the LUPA thresholds
due to the COVID-19 PHE, we are proposing to maintain the LUPA
thresholds finalized and displayed in Table 17 in the CY 2020 HH PPS
final rule with comment period (84 FR 60522) for CY 2022 payment
purposes. We believe that maintaining the LUPA thresholds for CY 2022
is the best approach because it mitigates potential fluctuations in the
thresholds caused by visit patterns changing from what we observed in
CY 2020 potentially due to the PHE. We will repost these LUPA
thresholds (along with the case-mix weights) that will be used for CY
2022 on the HHA Center web page.\9\ We solicit public comments on
maintaining the LUPA thresholds for CY 2022 payment purposes.
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\9\ 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 one-third of home health periods from each of the
clinical groups fall within each level. This means home health periods
in the low impairment level have responses for the functional OASIS
items that are associated with the lowest resource use, on average.
Home health periods in the high impairment level have responses for the
functional OASIS items that are associated with the highest resource
use on average.
For CY 2022, we propose to use CY 2020 claims data to update the
functional points and functional impairment levels by clinical group.
The CY 2018 HH PPS Proposed rule (82 FR 35320) and the HHGM technical
report from December 2016 posted on the HHA Center web page provide a
more detailed explanation as to the construction of these functional
impairment levels using the OASIS items. We are proposing to use this
same methodology previously finalized to update the functional
impairment levels for CY 2022. The updated OASIS functional points
table and the table of
[[Page 35893]]
functional impairment levels by clinical group for CY 2022 are listed
in Tables 13 and 14, respectively. We solicit public comments on the
updates to functional points and the functional impairment levels by
clinical group.
BILLING CODE 4120-01-P
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c. CY 2022 Comorbidity Subgroups
Thirty-day periods of care receive a comorbidity adjustment
category based on the presence of certain secondary diagnoses reported
on home health claims. These diagnoses are based on a home-health
specific list of clinically and statistically significant secondary
diagnosis subgroups with similar resource use, meaning the diagnoses
have at least as high as the median resource use and are reported in
more than 0.1 percent of 30-day periods of care. Home health 30-day
periods of care can receive a comorbidity adjustment under the
following circumstances:
Low comorbidity adjustment: There is a reported secondary
diagnosis on the home health-specific comorbidity subgroup list that is
associated with higher resource use.
High comorbidity adjustment: There are two or more
secondary diagnoses on the home health-specific comorbidity subgroup
interaction list that are associated with higher resource use when both
are reported together compared to if they were reported separately.
That is, the two diagnoses
[[Page 35895]]
may interact with one another, resulting in higher resource use.
No comorbidity adjustment: A 30- day period of care
receives no comorbidity adjustment if no secondary diagnoses exist or
none meet the criteria for a low or high comorbidity adjustment.
In the CY 2019 HH PPS final rule with comment period (83 FR 56406)
we stated that we would continue to examine the relationship of
reported comorbidities on resource utilization and make the appropriate
payment refinements to help ensure that payment is in alignment with
the actual costs of providing care. For CY 2022, we propose to use the
same methodology used to establish the comorbidity subgroups to update
the comorbidity subgroups using CY 2020 home health data.
For CY 2022, we propose to update the comorbidity subgroups to
include 20 low comorbidity adjustment subgroups as identified in Table
15 and 85 high comorbidity adjustment interaction subgroups as
identified in Table 16. The proposed CY 2022 low comorbidity adjustment
subgroups and the high comorbidity adjustment interaction subgroups
including those diagnoses within each of these comorbidity adjustments
will also be posted on the HHA Center web page at https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
We invite comments on the proposed updates to the low comorbidity
adjustment subgroups and the high comorbidity adjustment interactions
for CY 2022.
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BILLING CODE 4120-01-C
d. CY 2022 PDGM Case-Mix Weights
As finalized in the CY 2019 HH PPS final rule with comment period
(83 FR 56502), the PDGM places patients into meaningful payment
categories based on patient and other characteristics, such as timing,
admission source, clinical grouping using the reported principal
diagnosis, functional impairment level, and comorbid conditions. The
PDGM case-mix methodology results in 432 unique case-mix groups called
home health resource groups (HHRGs). We also finalized in the CY 2019
HH PPS final rule with comment period (83 FR 56515) to annually
recalibrate the PDGM case-mix weights using a fixed effects model with
the most recent and complete utilization data available at the time of
annual rulemaking. Annual recalibration of the PDGM case-mix weights
ensures that the case-mix weights reflect, as accurately as possible,
current home health resource use and changes in utilization patterns.
To generate the proposed recalibrated CY 2022 case-mix weights, we used
CY 2020 home health claims data with linked OASIS data (as of March 30,
2021). These data are the most current and complete data available at
this time. We believe that recalibrating the 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
[[Page 35898]]
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 11 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 home health agency level fixed effects in the regression
model. After estimating the regression model using 30-day periods, we
divide the coefficients that correspond to the functional status and
risk of hospitalization items by 10 and round to the nearest whole
number. Those rounded numbers are used to compute a functional score
for each 30-day period by summing together the rounded numbers for the
functional status and risk of hospitalization items that are applicable
to each 30-day period. Next, each 30-day period is assigned to a
functional impairment level (low, medium, or high) depending on the 30-
day period's total functional score. Each clinical group has a separate
set of functional thresholds used to assign 30-day periods into a low,
medium or high functional impairment level. We set those thresholds so
that we assign roughly a third of 30-day periods within each clinical
group to each functional impairment level (low, medium, or high).
Step 2: A second regression model estimates the relationship
between a 30-day period's resource use and indicator variables for the
presence of any of the comorbidities and comorbidity interactions that
were originally examined for inclusion in the PDGM. Like the first
regression model, this model also includes home health agency level
fixed effects and includes control variables for each 30-day period's
admission source, clinical group, timing, and functional impairment
level. After we estimate the model, we assign comorbidities to the low
comorbidity adjustment if any comorbidities have a coefficient that is
statistically significant (p-value of 0.05 or less) and which have a
coefficient that is larger than the 50th percentile of positive and
statistically significant comorbidity coefficients. If two
comorbidities in the model and their interaction term have coefficients
that sum together to exceed $150 and the interaction term is
statistically significant (p-value of 0.05 or less), we assign the two
comorbidities together to the high comorbidity adjustment.
Step 3: Hold the LUPA thresholds at their current thresholds as
described previously in this proposed rule.
Step 4: Take all non-LUPA 30-day periods and regress resource use
on the 30-day period's clinical group, admission source category,
episode timing category, functional impairment level, and comorbidity
adjustment category. The regression includes fixed effects at the level
of the home health agency. After we estimate the model, the model
coefficients are used to predict each 30-day period's resource use. To
create the case-mix weight for each 30- day period, the predicted
resource use is divided by the overall resource use of the 30-day
periods used to estimate the regression.
The case-mix weight is then used to adjust the base payment rate to
determine each 30-day period's payment. Table 17 shows the coefficients
of the payment regression used to generate the weights, and the
coefficients divided by average resource use.
BILLING CODE 4120-01-P
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[[Page 35900]]
The case-mix weights proposed for CY 2022 are listed in Table 19
and will also be posted on the HHA Center web page \10\ upon display of
this proposed rule.
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\10\ HHA Center web page: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center
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BILLING CODE 4120-01-C
To ensure the changes to the PDGM case-mix weights are implemented
in a budget neutral manner, we then apply a case-mix budget neutrality
factor to the CY 2022 national, standardized 30-day period payment
rate. Typically, the case-mix weight budget neutrality factor is
calculated using the most recent, complete home health claims data
available. However, due to the COVID-19 PHE, we looked at using the
previous calendar year's home health claims data (CY 2019) to determine
if there were significant differences between utilizing CY 2019 and CY
2020 claims data. We note that CY 2020 is the first year of actual PDGM
utilization data, therefore, if we were to use CY 2019 data due to the
PHE we would need to simulate 30-day periods from 60-day episodes under
the old system. We believe that using CY 2020 utilization data is more
appropriate than using CY 2019 utilization data because it is actual
PDGM utilization data. The case-mix budget neutrality factor is
calculated as the ratio of 30-day base payment rates such that total
payments when the CY 2022 PDGM case-mix weights
[[Page 35909]]
(developed using CY 2020 home health claims data) are applied to CY
2020 utilization (claims) data are equal to total payments when CY 2021
PDGM case-mix weights (developed using CY 2018 home health claims data)
are applied to CY 2020 utilization data. This produces a case-mix
budget neutrality factor for CY 2022 of 1.0344. For reasons described
previously, CY 2020 utilization data was used to calculate the case-mix
weight budget neutrality factor because it is the most recent complete
data we have at the time of this rulemaking.
We invite comments on the CY 2022 proposed case-mix weights and
proposed case-mix weight budget neutrality factor.
4. Proposed CY 2022 Home Health Payment Rate Updates
a. Proposed CY 2022 Home Health Market Basket Update for HHAs
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for home health be increased by a factor
equal to the applicable home health market basket update for those HHAs
that submit quality data as required by the Secretary. In the CY 2019
HH PPS final rule with comment period (83 FR 56425), we finalized a
rebasing of the home health market basket to reflect 2016 cost report
data. As such, based on the rebased 2016-based home health market
basket, we finalized that the labor share is 76.1 percent and the 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 through 56436).
Section 1895(b)(3)(B) of the Act requires that in CY 2015 and in
subsequent calendar years, except CY 2018 (under section 411(c) of the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
114-10, enacted April 16, 2015)), and CY 2020 (under section 53110 of
the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted
February 9, 2018)), the market basket percentage under the HHA
prospective payment system, as described in section 1895(b)(3)(B) of
the Act, be annually adjusted by changes in economy-wide productivity.
Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity
adjustment to be equal to the 10-year moving average of changes in
annual economy-wide private nonfarm business multifactor productivity
(MFP) (as projected by the Secretary for the 10-year period ending with
the applicable fiscal year, calendar year, cost reporting period, or
other annual period). The Bureau of Labor Statistics (BLS) is the
agency that publishes the official measure of private nonfarm business
MFP. Please visit http://www.bls.gov/mfp, to obtain the BLS historical
published MFP data.
The proposed home health update percentage for CY 2022 is based on
the estimated home health market basket update, specified at section
1895(b)(3)(B)(iii) of the Act, of 2.4 percent (based on IHS Global
Inc.'s first-quarter 2021 forecast with historical data through fourth-
quarter 2020). The estimated CY 2022 home health market basket update
of 2.4 percent is then reduced by a productivity adjustment, as
mandated by the section 3401 of the Patient Protection and Affordable
Care Act (the Affordable Care Act) (Pub. L. 111-148), currently
estimated to be 0.6 percentage point for CY 2022. In effect, the
proposed home health payment update percentage for CY 2022 is a 1.8
percent increase. Section 1895(b)(3)(B)(v) of the Act requires that the
home health update be decreased by 2 percentage points for those HHAs
that do not submit quality data as required by the Secretary. For HHAs
that do not submit the required quality data for CY 2022, the home
health payment update would be -0.2 percent (1.8 percent minus 2
percentage points). If more recent data becomes available after the
publication of this proposed rule and before the publication of the
final rule (for example, more recent estimates of the home health
market basket update and productivity adjustment), we would use such
data, if appropriate, to determine the home health payment update
percentage for CY 2022 in the final rule.
b. CY 2022 Home Health Wage Index
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the
Secretary to provide appropriate adjustments to the proportion of the
payment amount under the HH PPS that account for area wage differences,
using adjustment factors that reflect the relative level of wages and
wage-related costs applicable to the furnishing of home health
services. Since the inception of the HH PPS, we have used inpatient
hospital wage data in developing a wage index to be applied to home
payments. We propose to continue this practice for CY 2022, as we
continue to believe that, in the absence of home health-specific wage
data that accounts for area differences, using inpatient hospital wage
data is appropriate and reasonable for the HH PPS.
In the FY 2021 HH PPS final rule (85 FR 70298), we finalized the
proposal to adopt the revised OMB delineations with a 5 percent cap on
wage index decreases, where the estimated reduction in a geographic
area's wage index would be capped at 5 percent in CY 2021 only and no
cap would be applied to wage index decreases for the second year (CY
2022). Therefore, we propose to use the FY 2022 pre-floor, pre-
reclassified hospital wage index with no 5 percent cap on decreases as
the CY 2022 wage adjustment to the labor portion of the HH PPS rates.
For CY 2022, the updated wage data are for hospital cost reporting
periods beginning on or after October 1, 2017, and before October 1,
2018 (FY 2018 cost report data). We apply the appropriate wage index
value to the labor portion of the HH PPS rates based on the site of
service for the beneficiary (defined by section 1861(m) of the Act as
the beneficiary's place of residence).
To address those geographic areas in which there are no inpatient
hospitals, and thus, no hospital wage data on which to base the
calculation of the CY 2022 HH PPS wage index, we propose to continue to
use the same methodology discussed in the CY 2007 HH PPS final rule (71
FR 65884) to address those geographic areas in which there are no
inpatient hospitals. For rural areas that do not have inpatient
hospitals, we propose to use the average wage index from all contiguous
Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently,
the only rural area without a hospital from which hospital wage data
could be derived is Puerto Rico. However, for rural Puerto Rico, we do
not apply this methodology due to the distinct economic circumstances
that exist there (for example, due to the close proximity to one
another of almost all of Puerto Rico's various urban and non-urban
areas, this methodology would produce a wage index for rural Puerto
Rico that is higher than that in half of its urban areas). Instead, we
propose to continue to use the most recent wage index previously
available for that area. The most recent wage index previously
available for rural Puerto Rico is 0.4047. For urban areas without
inpatient hospitals, we use the average wage index of all urban areas
within the State as a reasonable proxy for the wage index for that
CBSA. For CY 2022, the only urban area without inpatient hospital wage
data is Hinesville, GA (CBSA 25980). The CY 2022 wage index value for
Hinesville, GA is 0.8557.
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing
revisions to the delineations of MSAs, Micropolitan Statistical Areas,
and CBSAs, and guidance on uses of the
[[Page 35910]]
delineation of these areas. In the CY 2015 HH PPS final rule (79 FR
66085 through 66087), we adopted OMB's area delineations using a 1-year
transition.
On August 15, 2017, OMB issued Bulletin No. 17-01 in which it
announced that one Micropolitan Statistical Area, Twin Falls, Idaho,
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300)
comprises the principal city of Twin Falls, Idaho in Jerome County,
Idaho and Twin Falls County, Idaho. The CY 2022 HH PPS wage index value
for CBSA 46300, Twin Falls, Idaho, will be 0.8757. Bulletin No. 17-01
is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
On April 10, 2018 OMB issued OMB Bulletin No. 18-03 which
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14,
2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10,
2018 OMB Bulletin No. 18-03. These bulletins established revised
delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas, and provided
guidance on the use of the delineations of these statistical areas. A
copy of OMB Bulletin No. 18-04 may be obtained at: https://www.bls.gov/bls/omb-bulletin-18-04-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 are proposing to adopt the updates set forth in OMB
Bulletin No. 20-01 consistent with our longstanding policy of adopting
OMB delineation updates, we note that specific wage index updates would
not be necessary for CY 2022 as a result of adopting these OMB updates.
In other words, these OMB updates would not affect any geographic areas
for purposes of the wage index calculation for CY 2022.
The proposed CY 2022 wage index is available on the CMS website at:
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
c. CY 2022 Annual Payment Update
(1) Background
The HH PPS has been in effect since October 1, 2000. As set forth
in the July 3, 2000 final rule (65 FR 41128), the base unit of payment
under the HH PPS was a national, standardized 60-day episode payment
rate. As finalized in the CY 2019 HH PPS final rule with comment period
(83 FR 56406), and as described in the CY 2020 HH PPS final rule with
comment period (84 FR 60478), the unit of home health payment changed
from a 60-day episode to a 30-day period effective for those 30-day
periods beginning on or after January 1, 2020.
As set forth in 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 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 2021:
Multiply the national, standardized 30-day period rate by
the patient's applicable case-mix weight.
Divide the case-mix adjusted amount into a labor (76.1
percent) and a non-labor portion (23.9 percent).
Multiply the labor portion by the applicable wage index
based on the site of service of the beneficiary.
Add the wage-adjusted portion to the non-labor portion,
yielding the case-mix and wage adjusted 30-day period 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
CMS provided preliminary monitoring data for the first year of PDGM
and presented a repricing method to determine the differences between
assumed and actual behavior changes and the impact of such on estimated
aggregate expenditures, as discussed in Section III.B of this
[[Page 35911]]
proposed rule. For CY 2022, we are not proposing to make any additional
permanent or temporary adjustments to the national, standardized 30-day
period payment in this proposed rule in accordance with section
1895(b)(3)(D) of the Act.
Section 1895(b)(3)(A)(i) of the Act requires that the standard
prospective payment rate and other applicable amounts be standardized
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a
budget-neutral manner. To determine the CY 2022 national, standardized
30-day period payment rate, we apply a case-mix weights recalibration
budget neutrality factor, a wage index budget neutrality factor and the
home health payment update percentage discussed in Section III.C.2 of
this proposed rule. As discussed previously, to ensure the changes to
the PDGM case-mix weights are implemented in a budget neutral manner,
we apply a case-mix weights budget neutrality factor to the CY 2021
national, standardized 30-day period payment rate. The proposed case-
mix weights budget neutrality factor for CY 2022 is 1.0344.
Additionally, we also apply a wage index budget neutrality to
ensure that wage index updates and revisions are implemented in a
budget neutral manner. Typically, the wage index budget neutrality
factor is calculated using the most recent, complete home health claims
data available. However, due to the COVID-19 PHE, we looked at using
the previous calendar year's home health claims data (CY 2019) to
determine if there were significant differences between utilizing 2019
and 2020 claims data. Our analysis showed that there is only a small
difference between the wage index budget neutrality factors calculated
using CY 2019 and CY 2020 home health claims data. Therefore, we have
decided to continue our practice of using the most recent, complete
home health claims data available; that is we are using CY 2020 claims
data for the CY 2022 payment rate updates.
To calculate the wage index budget neutrality factor, we simulated
total payments using CY 2020 home health claims utilization data for
non-LUPA 30-day periods using the proposed CY 2022 wage index and
compared it to our simulation of total payments for non-LUPA 30-day
periods using the CY 2021 wage index. By dividing the total payments
for non-LUPA 30-day periods using the CY 2022 wage index by the total
payments for non-LUPA 30-day periods using the CY 2021 wage index, we
obtain a wage index budget neutrality factor of 1.0013. We would apply
the wage index budget neutrality factor of 1.0013 to the 30-day period
payment rate.
Next, we would update the 30-day period payment rate by the CY 2022
home health payment update percentage of 1.8 percent. The CY 2022
national, standardized 30-day period payment rate is calculated in
Table 19.
[GRAPHIC] [TIFF OMITTED] TP07JY21.031
The CY 2022 national, standardized 30-day period payment rate for a
HHA that does not submit the required quality data is updated by the CY
2022 home health payment update of 1.8 percent minus 2 percentage
points and is shown in Table 20.
[GRAPHIC] [TIFF OMITTED] TP07JY21.032
(3) CY 2022 National Per-Visit Rates for 30-Day Periods of Care
The national per-visit rates are used to pay LUPAs and are also
used to compute imputed costs in outlier calculations. The per-visit
rates are paid by type of visit or HH discipline. The six HH
disciplines are as follows:
Home health aide (HH aide).
Medical Social Services (MSS).
Occupational therapy (OT).
Physical therapy (PT).
Skilled nursing (SN).
Speech-language pathology (SLP).
To calculate the CY 2022 national 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-
[[Page 35912]]
visit payments. We calculated the wage index budget neutrality factor
by simulating total payments for LUPA 30-day periods of care using the
CY 2022 wage index and comparing it to simulated total payments for
LUPA 30-day periods of care using the CY 2021 wage index. By dividing
the total payments for LUPA 30-day periods of care using the CY 2022
wage index by the total payments for LUPA 30-day periods of care using
the CY 2021 wage index, we obtained a wage index budget neutrality
factor of 1.0014. We apply the wage index budget neutrality factor in
order to calculate the CY 2022 national per-visit rates.
The LUPA per-visit rates are not calculated using case-mix weights.
Therefore, no case-mix weights budget neutrality factor is needed to
ensure budget neutrality for LUPA payments. Lastly, the per-visit rates
for each discipline are updated by the CY 2022 home health payment
update percentage of 1.8 percent. The national per-visit rates are
adjusted by the wage index based on the site of service of the
beneficiary. The per-visit payments for LUPAs are separate from the
LUPA 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 1.8 percent and are shown in Table 21.
[GRAPHIC] [TIFF OMITTED] TP07JY21.033
The CY 2022 per-visit payment rates for HHAs that do not submit the
required quality data are updated by the CY 2020 home health payment
update percentage of 1.8 percent minus 2 percentage points and are
shown in Table 22.
[GRAPHIC] [TIFF OMITTED] TP07JY21.034
We are reminding stakeholders of the policies finalized in the CY
2020 HH PPS final rule with comment period (84 FR 60544) and the
implementation of a new one-time Notice of Admission (NOA) process
starting in CY 2022. In that final rule, we finalized the lowering of
the up-front payment made in response to Requests for Anticipated
Payment (RAPs) to zero percent for all 30-day periods of care beginning
on or after January 1, 2021 (84 FR 60544). For CY 2021, all HHAs (both
existing and newly-enrolled HHAs) were required to submit a RAP at the
beginning of each 30-day period in order to establish the home health
period of care in the common working file and also to trigger the
consolidated billing edits. With the removal of the upfront RAP payment
for CY 2021, we relaxed the required information for submitting the RAP
for CY 2021 and also stated that the information required for
submitting an NOA for CYs 2022 and beyond would mirror that of the RAP
in CY 2021. Starting in CY 2022, HHAs will submit a one-time NOA that
establishes the home health period of care and covers all contiguous
30-day periods of care until the individual is discharged from Medicare
home health services. Also, for the one-time NOA for CYs 2022 and
[[Page 35913]]
beyond, we finalized a payment reduction if the HHA does not submit the
NOA for CYs 2022 and beyond within 5 calendar days from the start of
care. That is, if an HHA fails to submit a timely NOA for CYs 2022 and
beyond, the reduction in payment amount would be equal to a one-
thirtieth reduction to the wage and case-mix adjusted 30-day period
payment amount for each day from the home health start of care date
until the date the HHA submitted the NOA. In other words, the one-
thirtieth reduction would be to the 30-day period adjusted payment
amount, including any outlier payment, that the HHA otherwise would
have received absent any reduction. For LUPA 30-day periods of care in
which an HHA fails to submit a timely NOA, no LUPA payments would be
made for days that fall within the period of care prior to the
submission of the NOA. We stated that these days would be a provider
liability, the payment reduction could not exceed the total payment of
the claim, and that the provider may not bill the beneficiary for these
days.
We remind stakeholders that for purposes of determining if an NOA
is timely-filed, the NOA must be submitted within 5 calendar days after
the start of care for the first 30-day period of care. For example, if
the start of care for the first 30-day period is January 1, 2022, the
NOA would be considered timely-filed if it is submitted on or before
January 6, 2022.
Example
1/1/2022 = Day 0 (start of the first 30- day period of care)
1/6/2022 = Day 5 (An NOA submitted on or before this date would be
considered ``timely-filed''.)
1/7/2022 and after = Day 6 and beyond (An NOA submitted on and
after this date will trigger the penalty.) In the event that the NOA is
not timely-filed, the penalty is calculated from the first day of that
30-day period (in the example, the penalty calculation would begin with
the start of care date of January 1, 2022, counting as the first day of
the penalty) until the date of the submission of the NOA.
Also, in the CY 2020 HH PPS final rule with comment period (84 FR
60478), we finalized exceptions to the timely filing consequences of
the NOA requirements at Sec. 484.205(j)(4). Specifically, we finalized
that CMS may waive the consequences of failure to submit a timely-filed
NOA if it is determined that a circumstance encountered by a home
health agency is exceptional and qualifies for waiver of the
consequence. As finalized in the CY 2020 HH PPS final rule with comment
period and as set forth in regulation at 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.
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 proposed CY
2022 per-visit payment rates for those HHAs that submit the required
quality data, for LUPA periods that occur as the only period or an
initial period in a sequence of adjacent periods, if the first skilled
visit is SN, the payment for that visit would be $287.06 (1.8451
multiplied by $155.58), subject to area wage adjustment.
(5) Proposed Occupational Therapy LUPA Add-On Factor
In order to implement Division CC, section 115, of CAA 2021, we are
proposing conforming changes to regulations at Sec. Sec. 484.55(a)(2)
and 484.55(b)(3) that were revised to allow OTs to conduct initial and
comprehensive assessments for all Medicare beneficiaries under the home
health benefit when the plan of care does not initially include skilled
nursing care, but includes either PT or SLP. Because of this change, we
are proposing to establish a LUPA add-on factor for calculating the
LUPA add-on payment amount for the first skilled occupational therapy
visit in LUPA periods that occurs as the only period of care or the
initial 30-day period of care in a sequence of adjacent 30-day periods
of care. Currently, there are no sufficient data regarding the average
excess of minutes for the first visit in LUPA periods where the initial
and comprehensive assessments are conducted by occupational therapists.
Therefore, we propose to utilize the PT LUPA add-on factor of 1.6700 as
a proxy until we have CY 2022 data to establish a more accurate OT add-
on factor for the LUPA add-on payment amounts. We believe that the
similarity in the per-visit payment rates for both PT and OT make the
PT LUPA add-on factor the most appropriate proxy. We welcome comments
on this proposal.
d. Rural Add-On Payments for CY 2022
(1) Background
Section 421(a) of the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA) (Pub. L. 108-173) required, for home
health services furnished in a rural area (as defined in section
1886(d)(2)(D) of the Act), for episodes or visits ending on or
[[Page 35914]]
after April 1, 2004, and before April 1, 2005, that the Secretary
increase the payment amount that otherwise would have been made under
section 1895 of the Act for the services by 5 percent. Section 5201 of
the Deficit Reduction Act of 2003 (DRA) (Pub. L. 108-171) amended
section 421(a) of the MMA. The amended section 421(a) of the MMA
required, for home health services furnished in a rural area (as
defined in section 1886(d)(2)(D) of the Act), on or after January 1,
2006, and before January 1, 2007, that the Secretary increase the
payment amount otherwise made under section 1895 of the Act for those
services by 5 percent.
Section 3131(c) of the Affordable Care Act amended section 421(a)
of the MMA to provide an increase of 3 percent of the payment amount
otherwise made under section 1895 of the Act for home health services
furnished in a rural area (as defined in section 1886(d)(2)(D) of the
Act), for episodes and visits ending on or after April 1, 2010, and
before January 1, 2016. Section 210 of the MACRA amended section 421(a)
of the MMA to extend the rural add-on by providing an increase of 3
percent of the payment amount otherwise made under section 1895 of the
Act for home health services provided in a rural area (as defined in
section 1886(d)(2)(D) of the Act), for episodes and visits ending
before January 1, 2018.
Section 50208(a) of the BBA of 2018 amended section 421(a) of the
MMA to extend the rural add-on by providing an increase of 3 percent of
the payment amount otherwise made under section 1895 of the Act for
home health services provided in a rural area (as defined in section
1886(d)(2)(D) of the Act), for episodes and visits ending before
January 1, 2019.
(2) Rural Add-On Payments for CYs 2019 Through CY 2022
Section 50208(a)(1)(D) of the BBA of 2018 added a new subsection
(b) to section 421 of the MMA to provide rural add-on payments for
episodes or visits ending during CYs 2019 through 2022. It also
mandated implementation of a new methodology for applying those
payments. Unlike previous rural add-ons, which were applied to all
rural areas uniformly, the extension provided varying add-on amounts
depending on the rural county (or equivalent area) classification by
classifying each rural county (or equivalent area) into one of three
distinct categories: (1) Rural counties and equivalent areas in the
highest quartile of all counties and equivalent areas based on the
number of Medicare home health episodes furnished per 100 individuals
who are entitled to, or enrolled for, benefits under Part A of Medicare
or enrolled for benefits under Part B of Medicare only, but not
enrolled in a Medicare Advantage plan under Part C of Medicare (the
``High utilization'' category); (2) rural counties and equivalent areas
with a population density of 6 individuals or fewer per square mile of
land area and are not included in the ``High utilization'' category
(the ``Low population density'' category); and (3) rural counties and
equivalent areas not in either the ``High utilization'' or ``Low
population density'' categories (the ``All other'' category).
In the CY 2019 HH PPS final rule with comment period (83 FR 56443),
CMS finalized policies for the rural add-on payments for CY 2019
through CY 2022, in accordance with section 50208 of the BBA of 2018.
The CY 2019 HH PPS proposed rule (83 FR 32373) described the provisions
of the rural add-on payments, the methodology for applying the new
payments, and outlined how we categorized rural counties (or equivalent
areas) based on claims data, the Medicare Beneficiary Summary File and
Census data. The data used to categorize each county or equivalent area
is available in the Downloads section associated with the publication
of this rule at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html. In addition, an Excel file containing the
rural county or equivalent area name, their Federal Information
Processing Standards (FIPS) State and county codes, and their
designation into one of the three rural add-on categories is available
for download.
The HH PRICER module, located within CMS' claims processing system,
will increase the CY 2022 30-day base payment rates, described in
section III.C.3. of this proposed rule, by the appropriate rural add-on
percentage prior to applying any case-mix and wage index adjustments.
The CY 2019 through CY 2022 rural add-on percentages outlined in law
are shown in Table 23.
[GRAPHIC] [TIFF OMITTED] TP07JY21.035
e. Proposed Payments for High-Cost Outliers Under the HH PPS
(1) Background
Section 1895(b)(5) of the Act allows for the provision of an
addition or adjustment to the home health payment amount otherwise made
in the case of outliers because of unusual variations in the type or
amount of medically necessary care. Under the HH PPS and the previous
unit of payment (that is, 60-day episodes), outlier payments were made
for 60-day episodes whose estimated costs exceed a threshold amount for
each Home Health Resource Group (HHRG). The episode's estimated cost
was established as the sum of the national wage-adjusted per visit
payment amounts delivered during the episode. The outlier threshold for
each case-mix group or PEP adjustment defined as the 60-day episode
payment or PEP adjustment for that group plus a fixed-dollar loss (FDL)
amount. For the purposes of the HH PPS, the FDL amount is calculated by
multiplying the home health FDL ratio by a case's 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
[[Page 35915]]
threshold amount paid as outlier payments is referred to as the loss-
sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through
70399), section 3131(b)(1) of the Affordable Care Act amended section
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH
PPS payment rates such that aggregate HH PPS payments were reduced by 5
percent. In addition, section 3131(b)(2) of the Affordable Care Act
amended section 1895(b)(5) of the Act by redesignating the existing
language as section 1895(b)(5)(A) of the Act and 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 through
43742 and 81 FR 76702), we described our concerns regarding patterns
observed in home health outlier episodes. Specifically, we noted the
methodology for calculating home health outlier payments may have
created a financial incentive for providers to increase the number of
visits during an episode of care in order to surpass the outlier
threshold; and simultaneously created a disincentive for providers to
treat medically complex beneficiaries who require fewer but longer
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR
76702), we finalized changes to the methodology used to calculate
outlier payments, using a 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 PDGM beginning in CY 2020
and calculated payment for high-cost outliers based upon 30-day period
of care. Upon implementation of the PDGM and 30-day unit of payment, we
finalized the FDL ratio of 0.56 for 30-day periods of care in CY 2020.
Given that CY 2020 was the first year of the PDGM and the change to a
30-day unit of payment, we finalized to maintain the same FDL ratio of
0.56 in CY 2021 as we did not have sufficient CY 2020 data at the time
of CY 2021 rulemaking to proposed a change to the FDL ratio for CY
2021.
(2) Fixed Dollar Loss (FDL) Ratio for CY 2022
For a given level of outlier payments, there is a trade-off between
the values selected for the FDL ratio and the 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. Using CY 2020 claims data (as
of March 30, 2021), and given the statutory requirement that total
outlier payments does not exceed 2.5 percent of the total payments
estimated to be made under the HH PPS, we are proposing a FDL ratio of
0.41 for CY 2022.
6. Conforming Regulations Text Changes Regarding Allowed Practitioners
As stated in the May 2020 COVID-19 interim final rule with comment
period (85 FR 27550), we amended the regulations at parts 409, 424, and
484 to implement section 3708 of the CARES Act. This included defining
a nurse practitioner (NP), a clinical nurse specialist (CNS), and a
physician's assistant (PA) (as such qualifications are defined at
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
provider physician or allowed practitioner that performed the face-to-
face encounter. These regulations text changes are not time
[[Page 35916]]
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 this
proposed rule we are proposing 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.
III. Home Health Value-Based Purchasing (HHVBP) Model
A. Proposal To Expand the HHVBP Model Nationwide
1. Background
As authorized by section 1115A of the Act and finalized in the CY
2016 HH PPS final rule (80 FR 68624), the CMS Center for Medicare and
Medicaid Innovation (Innovation Center) implemented the Home Health
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),\11\ completed Home
Health Consumer Assessment of Healthcare Providers and Systems
(HHCAHPS) surveys, and claims-based measures; and (2) three New
Measures for which points were achieved for reporting data. Payment
adjustments for a given year are based on the TPS calculated for
performance two years' prior; for example, the CY 2018 payment
adjustments were based on CY 2016 performance.
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\11\ OASIS is the instrument/data collection tool used to
collect and report performance data by HHAs.
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In the CY 2017 HH PPS final rule (81 FR 76741 through 76752), CY
2018 HH PPS final rule (83 FR 51701 through 51706), and CY 2019 HH PPS
final rule (83 FR 56527 through 56547), we finalized changes to the
original Model. Some of those changes included adding and removing
measures from the applicable measure set, revising our methodology for
calculating benchmarks and achievement thresholds at the State level,
creating an appeals process for recalculation requests, and revising
our methodologies for weighting measures and assigning improvement
points.
On January 8, 2021, we announced that the HHVBP Model had been
certified for expansion nationwide,\12\ as well as our intent to expand
the Model through notice and comment rulemaking beginning no sooner
than CY 2022. The original Model has resulted in an average 4.6 percent
improvement in home health agencies' quality scores as well as average
annual savings of $141 million to Medicare.\13\
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\12\ https://www.cms.gov/files/document/certification-home-health-value-based-purchasing-hhvbp-model.pdf.
\13\ https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
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As described in this proposed rule, we are proposing to expand the
HHVBP Model (expanded Model/Model expansion) to all 50 States, the
District of Columbia and the territories starting in CY 2022. We are
proposing to codify HHVBP Model expansion policies at 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,\14\ the HHVBP Model
resulted in improved quality of care (for example, consistently
increasing TPS scores) and a reduction in Medicare expenditures through
three performance years of the HHVBP Model (CYs 2016 to 2018). The
HHVBP Model's intervention has led to savings without evidence of
adverse risks. The evaluation also found reductions in unplanned acute
care hospitalizations and skilled nursing facility (SNF) visits,
resulting in reductions in inpatient and SNF spending. Based on these
findings, the Secretary determined that expansion of the HHVBP Model
would reduce spending and improve the quality of care.
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\14\ 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
[[Page 35917]]
produce Medicare savings if expanded to all States.\15\
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\15\ 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 would continue to test
and evaluate the expanded HHVBP Model. In the future, we would assess
whether the expanded implementation of HHVBP is continuing to reduce
Medicare spending without reducing quality of care or to improve the
quality of patient care without increasing spending, and could modify
the expanded HHVBP Model as appropriate through rulemaking.
3. Overview
The proposed HHVBP Model expansion presents an opportunity to
improve the quality of care furnished to Medicare beneficiaries
nationwide through payment incentives to HHAs. If finalized, all
Medicare-certified HHAs in the 50 States, District of Columbia and the
territories would be required to participate in the expanded HHVBP
Model beginning January 1, 2022. These HHAs would compete on value
based on an array of quality measures related to the care that HHAs
furnish.
The proposed Model expansion would be tested under section 1115A of
the Act. Under section 1115A(d)(1) of the Act, the Secretary may waive
such requirements of Titles XI and XVIII and of sections 1902(a)(1),
1902(a)(13), and 1903(m)(2)(A)(iii) of the Act as may be necessary
solely for purposes of carrying out section 1115A of the Act with
respect to testing models described in section 1115A(b) of the Act. The
Secretary is not issuing any waivers of the fraud and abuse provisions
in sections 1128A, 1128B, and 1877 of the Act or any other Medicare or
Medicaid fraud and abuse laws for this Model expansion at this time. In
addition, CMS has determined that the anti-kickback statute safe harbor
for CMS-sponsored model arrangements and 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 proposed 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 are proposing to use the section 1115A(d)(1) of the Act waiver
authority to apply a reduction or increase of up to 5 percent to
Medicare payments to Medicare-certified HHAs delivering care to
beneficiaries in the 50 States, District of Columbia and the
territories, depending on the HHA's performance on specified quality
measures relative to its peers. Specifically, the expanded HHVBP Model
proposes to utilize the section 1115A(d)(1) of the Act waiver authority
to adjust the Medicare payment amounts under section 1895(b) of the
Act. In accordance with the authority granted to the Secretary in
section 1115A(d)(1) of the Act, we would waive section 1895(b)(4) of
the Act only to the extent necessary to adjust payment amounts to
reflect the value-based payment adjustments under this proposed
expanded Model for Medicare-certified HHAs in the 50 States, District
of Columbia and the territories. We may make changes to the payment
adjustment percentage through rulemaking in future years of the
expansion, as additional evaluation data from the HHVBP expanded Model
become available, and we learn about performance within the Model under
the expansion. The evaluation of the expanded Model would use a time
series type approach to examine the outcomes of interest (cost or
utilization) over time prior to the start of the intervention and
follow that outcome after the start of the expansion.
a. Overview of Timing and Scope
As noted, we are proposing to begin the expanded HHVBP Model on
January 1, 2022. Under this proposal, CY 2022 would be the first
performance year and CY 2024 would be the first payment year, with
payment adjustments in CY 2024 based on an HHA's performance in CY
2022. Performance year means the calendar year during which data are
collected for the purpose of calculating a competing HHA's performance
on applicable quality measures. Payment year means the calendar year in
which the applicable percent, a maximum upward or downward adjustment,
applies.
The proposed expanded Model would apply to all Medicare-certified
HHAs in the 50 States, District of Columbia and the territories, which
means that all Medicare-certified HHAs that provide services in the 50
States, District of Columbia and the territories would be required to
compete in the expanded Model. We are proposing to codify this
requirement at Sec. 484.350. We are proposing to define a `competing
HHA' within the scope of the proposed expanded HHVBP Model as an HHA
that has a current Medicare certification and is being paid by CMS for
home health care services. We propose that all HHAs certified for
participation in Medicare before January 1, 2021 would have their CY
2022 performance assessed and would be eligible for a CY 2024 payment
adjustment. We propose to base participation in the expanded Model on
CMS Certification Numbers (CCNs), meaning that the Total Performance
Score as discussed further in section III.A.7.a. of this proposed rule
and payment adjustment would be calculated based on an HHA's CCN.\16\
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\16\ 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 http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title42/42cfr484_main_02.tpl.
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b. Overview of the Payment Adjustment
As proposed, the distribution of payment adjustments would be based
on quality performance, as measured by both achievement and
improvement, across a proposed set of quality measures constructed to
minimize burden as much as possible and improve care. Competing HHAs
that demonstrate they can deliver higher quality of care in a given
performance year measured against a baseline year relative to peers
nationwide (as defined by larger- versus smaller-volume cohorts based
upon their unique beneficiary count in the prior calendar year), could
have their HH PPS claims final payment amount adjusted higher than the
amount that otherwise would be paid. Competing HHAs that do not perform
as well as other competing HHAs in the same volume-based cohort might
have their HH PPS claims final payment amount reduced and those
competing HHAs that perform similarly to others in the same volume-
based cohort might have no payment adjustment. This operational concept
is similar in practice to what is used in the Hospital Value-Based
Purchasing (HVBP) Program (76 FR 26531).
We expect that the risk of having payments adjusted in this manner
would provide an incentive among all competing HHAs to provide
significantly better quality through improved planning, coordination,
and management of care. Under the expanded duration and scope of this
Model, we would continue to examine
[[Page 35918]]
whether the proposed adjustments to the Medicare payment amounts that
would otherwise be made to competing HHAs would result in statistically
significant improvements in the quality of care being delivered to
Medicare beneficiaries, as well as reductions in Medicare spending. The
degree of the payment adjustment would be dependent on the level of
quality achieved or improved from the baseline year, with the highest
upward performance adjustments going to competing HHAs with the highest
overall level of performance based on either achievement or improvement
in quality. The size of a competing HHA's payment adjustment for each
year under the expanded Model would be dependent upon that HHA's
performance with respect to the applicable performance year relative to
other competing HHAs in the same volume-based cohort and relative to
its own performance during the baseline year. Details are discussed in
sections III.A.4, III.A.5, and III.A.7.a of this proposed rule.
In addition, at Sec. 484.345 we propose to add the following
definitions:
Achievement threshold
Applicable measure
Applicable percent
Baseline year
Benchmark
Competing home health agency
Home health prospective payment system
Improvement threshold
Larger-volume cohort
Linear exchange function
Nationwide
Payment adjustment
Payment year
Performance year
Smaller-volume cohort
Total Performance Score
4. Defining Cohorts for Benchmarking and Competition
Under the original HHVBP Model, we grouped HHAs into cohorts by
State for setting benchmarks and achievement thresholds and by both
State and smaller- versus larger-volume HHAs when determining the
cohorts used for competing for payment adjustments, in accordance with
Sec. 484.330. For the nationwide expansion of the HHVBP Model, we are
proposing to redefine the cohort structure to account for States,
territories, and the District of Columbia with smaller numbers of HHAs,
while also allowing for the use of volume-based cohorts in determining
benchmarks, achievement thresholds, and payment adjustments.
a. Proposed Smaller- and Larger-Volume Cohorts
As discussed further in this section, we believe that separating
smaller- and larger-volume HHAs into cohorts under the expanded Model
would facilitate like comparisons by allowing for the majority of HHAs
to receive benchmarks and compete for payment against other HHAs of
similar size and based on the same set of measures. As under the
original HHVBP Model, we propose to align the larger-volume cohort with
the group of competing HHAs that administers the Home Health Care
Consumer Assessment of Healthcare Providers and Systems (HHCAHPS)
survey, in accordance with the HH QRP regulations concerning the
HHCAHPS survey in Sec. 484.245(b), and we propose to align the Model's
smaller-volume HHA cohort with the group of HHAs that are exempt from
submitting the HHCAHPS survey under HH QRP under Sec.
484.245(b)(1)(iii)(A). Under the expanded HHVBP Model, we would not
alter the HHCAHPS survey current scoring methodology or the
participation requirements in any way. Details on HHCAHPS survey
scoring methodology are available at: https://homehealthcahps.org/Survey-and-Protocols/Survey-Materials.\17\
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\17\ Detailed scoring information is contained in the Protocols
and Guidelines manual posted on the HHCAHPS website and available at
https://homehealthcahps.org/Survey-and-Protocols/Survey-Materials.
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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 eligible unique HHCAHPS
survey patients must annually submit their total HHCAHPS survey patient
count to CMS to be exempt from the HHCAHPS survey reporting
requirements for a calendar year. As under the original HHVBP Model, we
propose to align with this HHCAHPS survey reporting requirement by
defining the larger-volume cohort as those HHAs that are required to
submit an HHCAHPS survey in the performance year. As under the original
Model, we also propose to set an HHCAHPS survey measure minimum of at
least 40 completed HHCAHPS surveys in the performance year for those
HHAs to receive a score on the HHCAHPS survey measure, as reflected in
proposed 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 believe that separating smaller- and
larger-volume HHAs into distinct cohorts would allow for the majority
of HHAs to compete against other HHAs of similar size and based on the
same set of measures.
b. Proposed Cohorts for the Model Expansion
As discussed, we believe that applying separate larger- and
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);\18\ and (2) set stable, reliable benchmarks
and achievement thresholds that are not heavily skewed by outliers. The
LEF is designed so that the majority of the payment adjustment values
fall closer to the median and a smaller percentage of HHAs receive
adjustments at the higher and lower ends of the distribution. However,
when only a small number of HHAs fall within a cohort, one HHA's
outlier TPS could skew the payment adjustments and deviate from the
intended design of the LEF payment methodology. As a result, a key
consideration in defining the cohorts is ensuring sufficient HHA counts
within each cohort.
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\18\ 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 proposed 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. Expanding the HHVBP
Model beyond the nine mid- to large-sized States included in the
original Model requires us to re-examine these cohort definitions
because, certain territories and the District of Columbia would fall
short of the original Model's minimum of 8 HHAs to compose their own
cohort even where the volume-based cohorts are combined. This was not
an issue in the original Model because the nine selected States are
relatively populous as compared to the smaller States,
[[Page 35919]]
territories, and the District of Columbia that would be included in the
expanded Model. Based on CY 2019 Home Health Compare Star Ratings, we
evaluated the viability of smaller- and larger-volume cohorts, as
defined previously, for each of the 55 States, territories, and the
District of Columbia. Based on our analysis, of the 110 potential
cohorts based on both State and HHA volume for the expanded HHVBP
Model, 46 of the 110 potential cohorts had too few HHAs to reliably
meet the original Model minimum of 8 HHAs, after accounting for the
risk of attrition from the expanded Model. Under this approach, for 42
of these 46 States and territories, the smaller-volume cohorts would
need to be combined with the larger-volume cohorts in their States and
territories, while 3 territories and the District of Columbia would
need to be combined with other States or territories since they do not
meet the 8 HHA minimum after consolidating the volume-based cohorts.
See Table 24 for the counts of HHAs in each of the potential cohorts,
if we were to apply separate State- and volume-based cohorts for each
State, territory, and the District of Columbia under the expanded
Model.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP07JY21.036
BILLING CODE 4120-01-C
As noted, under the original HHVBP Model, a minimum of eight HHAs
is required for each size cohort. For the expanded HHVBP Model, we are
proposing to establish cohorts prospectively and with sufficient HHA
counts to prevent the need to combine multiple cohorts retrospectively.
We propose to provide HHAs with their
[[Page 35920]]
applicable benchmarks and achievement thresholds prior to the start of
or during the performance year so that they can be used to set
performance targets to guide HHAs' quality improvement projects. To
reliably define cohorts prospectively and to avoid regrouping multiple
States, territories, or the District of Columbia into a single cohort
retrospectively based solely on their lower HHA counts, we estimate
that a minimum of 20 HHAs in each cohort would be necessary to ensure
that attrition and variation in episode counts do not lead to
insufficient HHA counts at the end of the performance year. Based on
the data set forth in Table 24, 61 out of the 110 potential cohorts
would have fewer than 20 HHAs in a size-based cohort, and 11 out of
those potential cohorts would not meet the 20 HHA minimum after
combining the size-based cohorts.
To allow for a sufficient number of HHAs in each volume-based
cohort, for purposes of setting benchmarks and achievement thresholds
and determining payment adjustments, we are proposing to use cohorts
based on all HHAs nationwide, rather than by State as under the
original Model. Referencing the CY 2019 data in Table 24, under this
approach, 7,084 HHAs would fall within the larger-volume cohort and 485
HHAs fall within the smaller-volume cohort. These HHA counts would
provide a sufficiently large number of values in each cohort to allow
ranking of HHA performance scores and payment adjustment percentages
across the range of -5 percent to +5 percent. Further, our analysis
found that many of the smaller-volume HHAs would not receive a score on
the HHCAHPS survey measures, which are proposed to account for
30percent of the overall TPS, while most of the larger-volume cohort
HHAs would be scored on the full set of applicable measures.
Accordingly, and as previously discussed, we believe the volume-based
cohorts would allow for competition among HHAs across similar measures.
Using nationwide rather than State/territory-based cohorts in
performance comparisons would also be consistent with the Skilled
Nursing Facility and Hospital VBP Programs, in addition to the Home
Health Compare Star Ratings. Finally, this option would be the least
operationally complex to implement.
For the reasons discussed, we believe the use of nationwide
smaller- and larger-volume-based cohorts would allow for appropriate
groupings of HHAs under the expanded Model while also providing
sufficient numbers of HHAs in each cohort for purposes of setting
stable and reliable benchmarks and achievement thresholds and allowing
for a robust distribution of payment adjustments. However, we also
considered an alternative approach of using State/territory-based
cohorts, without volume-based groupings. Applying the State, territory,
and District of Columbia-level cohorts, we found that 11 of the 55
potential cohorts would have fewer than 20 HHAs based on the CY 2019
Home Health Star Ratings data. As noted, we do not believe this would
allow for a sufficient number of HHAs to develop prospective benchmarks
and achievement thresholds. While one approach would be to exclude any
States, territories, or the District of Columbia from the expanded
Model for years in which there are fewer than 20 HHAs in the cohort, we
believe such a policy would be inconsistent with the goal of including
all eligible HHAs nationwide in the Model. Another option would be to
consolidate those States, territories, and the District of Columbia
with less than 20 HHAs in the cohort, and to calculate benchmarks,
achievement thresholds, and payment adjustments based on that
consolidated grouping of HHAs. We note that while slight differences do
exist between quality measure scores based on geographic location, we
do not believe that codifying these small differences into long-term
performance standards is necessary to appropriately determine payment
adjustments under the expanded Model.
We are proposing to establish nationwide volume-based cohorts for
the expanded HHVBP Model, such that HHAs nationwide would compete
within either the larger-volume cohort or the smaller-volume cohort. We
propose to codify this policy at 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 are also requesting comment on the alternative approach of
applying State/territory-based cohorts only, without volume-based
cohorts, which we may finalize after consideration of comments
received.
We seek public comment on these proposals.
5. Proposed Payment Adjustment Percentage and Performance Assessment
and Payment Adjustment Periods
a. Proposed Payment Adjustment
Under the original Model, the payment adjustment ranges from a
minimum of 3 percent in 2018 to maximum of 8 percent in 2022. For the
expanded Model, we are proposing that the maximum payment adjustment,
upward or downward, would be 5 percent. We believe that beginning the
expansion with a 5 percent maximum payment adjustment would strike a
balance between the 3 percent maximum adjustment that applied for CY
2018, the first payment year of the original HHVBP Model, and the 7
percent maximum adjustment currently in place for CY 2021. As proposed
in section III.A.3.a. of this proposed rule, the first payment year of
the expanded HHVBP Model would be CY 2024 (January 1, 2024 through
December 31, 2024), with payment adjustments based on performance in CY
2022 (January 1, 2022 through December 31, 2022). We may consider
changes to the proposed 5 percent maximum payment adjustment percentage
through rulemaking in future years of the expansion, as additional
evaluation data from the original Model and expansion become available.
We note that the CMS Actuary certification was based on evaluation of
the Model when the maximum payment adjustment was 3 percent. However,
in their certification memo, they indicated they believe the Model
would result in savings at higher payment adjustment amounts as well.
We seek public comment on the proposed payment adjustment
percentage.
b. Proposed Baseline Year
(1) General
For the expanded HHVBP Model, due to the potentially de-stabilizing
effects of the COVID-19 public health emergency (PHE) on quality
measure data in CY 2020, we propose that the baseline year would be CY
2019 (January 1, 2019 through December 31, 2019) for the CY 2022
performance year/CY 2024 payment year and subsequent years. The data
from this baseline year would provide a basis from which each
respective HHA's performance would be measured for purposes of
calculating achievement and improvement points under the expanded
Model. We may propose to update the baseline year for subsequent years
of the expanded Model through future rulemaking. We would also propose
the applicable baseline year for any additional quality measures that
may be added to the measure set for the expanded HHVBP Model through
future rulemaking.
We seek public comment on the proposed baseline year for the
expanded Model.
[[Page 35921]]
(2) New HHAs
As noted, we are generally proposing that for the expanded Model,
the baseline year would be CY 2019 (January 1, 2019 through December
31, 2019) for the CY 2022 performance year/CY 2024 payment year and
subsequent years. For new HHAs, specifically those HHAs that are
certified by Medicare on or after January 1, 2019, we are proposing
that the baseline year under the expanded Model would be the HHA's
first full CY of services beginning after the date of Medicare
certification, with the exception of HHAs certified on January 1, 2019
through December 31, 2019, for which the baseline year would be CY
2021. Furthermore, we propose that new HHAs would begin competing under
the expanded HHVBP Model in the first full calendar year following the
full calendar year baseline year. For example, and as previously
discussed, we are proposing that all HHAs certified for participation
in Medicare before January 1, 2021 would have their CY 2022 performance
assessed and would be eligible for a CY 2024 payment adjustment. For
HHAs certified on January 1, 2020 through December 31, 2020, the
baseline year would be CY 2021, the first full CY of services beginning
after the date of Medicare certification. For those HHAs certified on
January 1, 2019 through December 31, 2019, the baseline year would also
be CY 2021, rather than CY 2020 (the first full CY of services
beginning after the date of Medicare certification), due to the
potentially destabilizing effects of the PHE on quality measure data in
CY 2020. For an HHA certified by Medicare on January 1, 2021 through
December 31, 2021, for example, the first full calendar year of
services that would establish the HHA's baseline year would be CY 2022.
The HHA's first performance year would be CY 2023 and the HHA's first
payment year, based on CY 2023 performance, would be CY 2025. Table 25
shows the proposed HHA baseline, performance and payment years based on
the HHA's Medicare-certification date through December 31, 2021.
[GRAPHIC] [TIFF OMITTED] TP07JY21.037
We also propose to codify our proposal on new HHAs at Sec.
484.350. We seek public comment on this proposal.
6. Quality Measures
a. General Considerations Used for the Selection of Quality Measures
for the Expanded HHVBP Model
We plan to apply, to the extent possible, principles from CMS'
Meaningful Measures Initiative in selecting the applicable measures as
defined at 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 quality of care;
Care coordination; Population/community health; efficiency and cost
reduction; safety; and, Patient and caregiver-centered experience.
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\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 believe that Medicare-certified HHAs should be evaluated using
measures designed to encompass multiple NQS domains, and provide future
flexibility to incorporate and study newly developed measures over
time. Additionally, so that measures for the expanded HHVBP Model take
a more holistic view of the patient beyond a particular disease,
functional status, State or care setting, we would prioritize outcome
measures that have the potential to follow patients across multiple
settings, reflect a multi-faceted approach, and foster the intersection
of health care delivery and population health.
The proposed expanded Model measures mostly align with those under
the HH QRP. However, we intend to consider new measures for inclusion
in subsequent years of the expanded HHVBP Model through future
rulemaking. We may consider adding new measures to the expanded HHVBP
Model measure set that address gaps within the NQS domains or the home
health service line and are good indicators of home health quality of
care. When available, NQF endorsed measures would be used. The expanded
Model's section 1115A of the Act authority also affords the opportunity
to study other measures, such as, measures developed in other care
settings or new to the home health industry, should CMS identify such
measures. A key consideration behind this approach is to use measures
that are readily available, and, in subsequent Model years, augment the
applicable measure set with innovative measures that have the potential
to be impactful and fill critical measure gap areas. This approach to
quality measure selection aims to balance the burden of collecting data
with the inclusion of new and important measures. We would carefully
consider the potential burden on HHAs to report the measure data that
is not already collected through existing quality measure data
reporting systems and reiterate that we would propose any new measures
through future rulemaking.
[[Page 35922]]
b. Proposed Measure Set Beginning With the CY 2022 Performance Year/CY
2024 Payment Year and Subsequent Years
We propose that the initial applicable measure set for the expanded
HHVBP Model for the CY 2022 performance year focus on patient outcome
and functional status, utilization, and patient experience. The
proposed measures were also used under the original Model (83 FR
56533). However, we note that no ``New Measures'' as defined in the
original Model (80 FR 68674) are being proposed for data collection
under the expanded Model beginning with the CY 2022 performance year
given there was sufficient data collected on the ``New Measures'' under
the original Model for analysis of the appropriateness for use in the
home health setting. We note that any future additional measures
proposed for the expanded HHVBP Model would not be considered ``New
Measures'' as used in the original Model.
Beginning with the CY 2022 performance year/CY 2024 payment year
and for subsequent years, we propose the following measures as detailed
in Table 26 for inclusion in the expanded Model. The measure set also
includes outcome measures, which illustrate the end result of care
delivered to HHA patients and address an important quality aim for HHA
patients. We believe the proposed measure set under the expanded HHVBP
Model, where most measures currently align with HH QRP measures,
supports enhancing quality because of the value-based incentives
provided under the expanded Model. Further, we believe that the
expanded Model measure set, as proposed, includes an array of measures
that would capture the care that HHAs furnish and incentivize quality
improvement. The measures in the proposed measure set are divided into
measure categories based on their data source as indicated in Table 26:
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 proposed rule). That is, each
component counts as one applicable measure towards the five measure
minimum that is required for an HHA to receive a Total Performance
Score (TPS) (this is discussed in more detail in section III.A.7.d of
this proposed rule).
BILLING CODE 4120-01-P
[[Page 35923]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.038
[[Page 35924]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.039
Table 27 provides more granular detail on the elements of the Home
Health Care Consumer Assessment of Healthcare Providers and Systems
(HHCAHPS) Survey measure.
[[Page 35925]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.040
[[Page 35926]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.041
[[Page 35927]]
BILLING CODE 4120-01-C
(1) Additional Background on the Total Normalized Composite Measures
The proposed measure set includes two composite measures: Total
Normalized Composite (TNC) Self-Care and TNC Mobility, which were
included in the original HHVBP Model measure set in CY 2019, as
finalized in the CY 2019 HH PPS final rule (83 FR 56529 through 56535).
The methodology for these measures take into account patients who may
not have goals for improvement.
The proposed TNC Self-Care measure computes the magnitude of
change, either positive or negative, based on a normalized amount of
possible change on each of six OASIS-based quality outcomes. These six
outcomes are as follows:
Improvement in Grooming (M1800)
Improvement in Upper Body Dressing (M1810)
Improvement in Lower Body Dressing (M1820)
Improvement in Bathing (M1830)
Improvement in Toileting Hygiene (M1845)
Improvement in Eating (M1870)
The TNC Mobility measure computes the magnitude of change, either
positive or negative, based on the normalized amount of possible change
on each of three OASIS-based quality outcomes. These three outcomes are
as follows:
Improvement in Toilet Transferring (M1840)
Improvement in Bed Transferring (M1850)
Improvement in Ambulation/Locomotion (M1860)
For each TNC measure, we calculate at the episode level and then
aggregate to the home health agency level using a five-step process:
Steps 1 to 3 calculate the normalized change values for each applicable
OASIS item at the episode level. Steps 4 and 5 aggregate these values
to the agency level. As composite measures, the TNC Self-Care and TNC
Mobility measures reflect multiple OASIS items, so there are no
numerators or denominators for these two measures. A detailed
description of the five steps can be found at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/hhvbp%20computing%20the%20hhvbp%20composite%20measures.pdf. We expect
that HHAs already focus on improvement in such areas not just because
such items are included in the OASIS, but because self-care and
mobility are areas of great importance to patients and families.
Improvement in such areas may allow beneficiaries to remain in the home
setting (versus an institution) and contribute to beneficiaries'
quality of life. The risk adjustment methodology for these two measures
recalibrates the expectations for improvement by including risk factors
for a wide variety of beneficiary-level factors, including age, risk
for hospitalization, condition categories, living arrangements and
caregivers available, pain, cognitive function, baseline functional
status, and others. For instance, a beneficiary with impaired cognition
would not be expected to improve in self-care as much as a beneficiary
with intact cognition. In effect, the self-care improvement score would
shift up slightly for a beneficiary with impaired cognition relative to
a beneficiary without cognitive impairment to account for the
difference in expectations. Both TNC measures' computations can be
found at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/hhvbp%20computing%20the%20hhvbp%20composite%20measures.pdf
and the technical specifications can be found at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/hhvbp%20technical%20specification%20resource%20for%20composite%20outcome%20measures_4.pdf. Additional information on the predictive modeling
and methodology for the composite measures can be found in the CY 2019
HH PPS final rule (83 FR 56529 through 56535).
We note that we had considered the inclusion of stabilization
measures which are measures that identify all patients whose function
has not declined, including both those who have improved or stayed the
same in the original HHVBP Model's measure set and refer readers to the
CY 2016 HH PPS final rule (80 FR 68669 through 68670) and the CY 2019
HH PPS final rule (83 FR 56529 through 56535). In the CY 2016 final
rule, we explained that we considered using some of the stabilization
measures for the original Model and found that the average HHA
stabilization measure scores ranged from 94 to 96 percent and, with
average rates of nearly 100 percent. We do not believe these high
measure scores would allow for meaningful comparisons between
competing-HHAs on the quality of care delivered. We acknowledge that
skilled care may be necessary to improve a patient's current condition,
to maintain the patient's current condition, or to prevent or slow
further deterioration of the patient's condition. However, we believe
that the two proposed TNC measures represent a new direction in how
quality of patient care is measured in home health as patients who
receive care from an HHA may have functional limitations and may be at
risk for further decline in function because of limited mobility and
ambulation.
(2) Additional Background on the Home Health Care Consumer Assessment
of Healthcare Providers and Systems Survey Measure
The Home Health Care Consumer Assessment of Healthcare Providers
and Systems Survey (HHCAHPS) survey is part of a family of
CAHPS[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.\21\
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\21\ 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's data
submission requirements, which are codified for that program at 42 CFR
484.245(b). As proposed, expanded HHVBP Model participants would not
need to submit separate HHCAHPS survey measure data already submitted
as a requirement under HH QRP, because the requirements as proposed for
the expanded Model are aligned with those currently under HH QRP. For
more details about the HHCAHPS Survey, please see https://homehealthcahps.org/.
We invite public comment on our proposed measure set.
c. Measure Modifications
During the expanded Model, we would monitor the quality measures
for lessons learned and address any needed
[[Page 35928]]
adjustments or modifications to the expanded Model measure set.
(1) Proposed 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 emergency, CMS-identified, a technical expert panel (TEP), or
NQF. How we incorporate those updates would depend on whether the
changes are substantive or non-substantive.
With respect to what constitutes a substantive versus a non-
substantive change, we expect to make this determination on a measure-
by-measure basis. Examples of such non-substantive changes might
include updated diagnosis or procedure codes, medication updates for
categories of medications, broadening of age ranges, and changes to
exclusions for a measure. We believe that 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 propose that, in the event that an update to a measure is
necessary in a manner that we consider to not substantially change the
nature of the measure, we will use a sub-regulatory process to
incorporate those updates to the measure specifications. Specifically,
we would revise the information that is posted on the CMS website so
that it clearly identifies the updates and provides links to where
additional information on the updates can be found. In addition, we
would provide sufficient lead time for HHAs to implement the changes
where changes to the data collection systems would be necessary.
We are also proposing to use notice and comment rulemaking to adopt
changes to measures that we consider to substantially change the nature
of the measure. Examples of changes that we might consider to be
substantive would be those in which the changes are so significant that
the measure is no longer the same measure, or when a standard of
performance assessed by a measure becomes more stringent, such as
changes in acceptable timing of medication, procedure/process, test
administration, or expansion of the measure to a new setting. We
believe that our proposal adequately balances the need to incorporate
changes to measures used in the expanded HHVBP Model in the most
expeditious manner possible, while preserving the public's ability to
comment on updates to measures that so fundamentally change a measure
that it is no longer the same measure originally adopted. We note that
CMS adopted a similar policy for the HH QRP in the CY 2015 HH PPS final
rule (79 FR 66079 through 66081).
We invite public comment on our proposal.
d. Measure Removals
The measure set used for the expanded Model would be subject to
change including the removal of measures during subsequent years. In
this proposed rule, for greater transparency, we propose factors we
would consider in proposing to remove a measure as well as a policy for
when immediate suspension is necessary.
(1) Proposed Removal Factors
We propose to generally use the below removal factors when
considering a quality measure for removal for use in the expanded HHVBP
Model:
Factor 1. Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made (that is, topped out). To determine ``topped-
out'' criteria, we will calculate the top distribution of HHA
performance on each measure, and if the 75th and 90th percentiles are
statistically indistinguishable, we will consider the measure topped-
out.
Factor 2. Performance or improvement on a measure does not
result in better patient outcomes.
Factor 3. A measure does not align with current clinical
guidelines or practice.
Factor 4. A more broadly applicable measure (across
settings, populations, or conditions) for the particular topic is
available.
Factor 5. A measure that is more proximal in time to
desired patient outcomes for the particular topic is available.
Factor 6. A measure that is more strongly associated with
desired patient outcomes for the particular topic is available.
Factor 7. Collection or public reporting of a measure
leads to negative unintended consequences other than patient harm.
Factor 8. The costs associated with a measure outweigh the
benefit of its continued use in the program.
With respect to Factor 8, under our Meaningful Measures Initiative,
we are engaging in efforts to ensure that the expanded HHVBP Model
measure set continues to promote improved health outcomes for
beneficiaries while minimizing the overall costs associated with the
program. We believe that these costs are multifaceted and include not
only the burden associated with reporting, but also the costs
associated with implementing and maintaining the expanded HHVBP Model.
We have identified several different types of costs, including, but not
limited to the following:
Provider and clinician information collection burden and
burden associated with the submitting/reporting of quality measures to
CMS.
The provider and clinician cost associated with complying
with other HH programmatic requirements.
The provider and clinician cost associated with
participating in multiple quality programs, and tracking multiple
similar or duplicative measures within or across those programs.
The cost to CMS associated with the program oversight of
the measure, including measure maintenance and public display.
The provider and clinician cost associated with compliance
with other Federal and State regulations (if applicable).
For example, it may be of limited benefit to retain or maintain a
measure which our analyses show no longer meaningfully supports the
expanded HHVBP Model goals (for example, no longer provides incentives
for better quality care with greater efficiency). It may also be costly
for HHAs to track confidential feedback and publicly reported
information on a measure where we use the measure in more than one
initiative, model, or program. We may also have to expend resources to
maintain the specifications for the measure, including the tools needed
to collect, validate, analyze, and publicly report the measure data.
When these costs outweigh the evidence supporting the continued use
of a measure in the expanded HHVBP Model, we believe that it may be
appropriate to remove the measure from the Model. Although we recognize
that the expanded HHVBP Model is to encourage HHAs to improve
beneficiary outcomes by incentivizing health care providers, we also
recognize that this can have limited utility where, for example, the
data is of limited use because it is not meaningful. In these cases,
removing the measure from the expanded HHVBP Model may better
accommodate the costs of expansion administration and compliance
without sacrificing improved health outcomes.
[[Page 35929]]
We propose 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 necessitates the removal of a
measure that is not currently captured in one of the factors noted
previously. In such cases, we would still use notice and comment
rulemaking to remove the measure and provide the reasons for doing so.
We seek public comment on our proposals.
(2) Proposed Measure Suspension Policy
Removal of an expanded HHVBP Model measure would take place through
notice and comment rulemaking as proposed above unless we determine
that a measure is causing concern for patient safety or harm. We
propose that in the case of an expanded HHVBP Model measure for which
there is a reason to believe that the continued collection raises
possible patient safety concerns, we would promptly suspend the measure
and immediately notify HHAs and the public through the usual
communication channels, including listening sessions, memos, email
notification, and Web postings. We would then propose to remove or
modify the measure as appropriate during the next rulemaking cycle.
We request public comment on our proposal.
e. Future Topics or Measure Considerations
(1) Consideration To Align or Remove Measures With the HH QRP
We note that in section IV.C. of this proposed rule, the CMS
proposes to replace the Acute Care Hospitalization During the First 60
Days of Home Health (ACH) measure and Emergency Department Use Without
Hospitalization During the First 60 days of Home Health (ED Use)
measure with the Home Health Within-Stay Potentially Preventable
Hospitalization (PPH) for the HH QRP measure beginning with the CY 2023
under the in the HH QRP. We note that while both the ACH and ED Use
measure are being proposed for removal under the HH QRP, these measures
are being proposed for inclusion in the expanded HHVBP Model beginning
with the CY 2022 performance year. We seek public comment on whether we
should instead align the expanded HHVBP Model with the proposed changes
for HH QRP by proposing to remove the same two measures from the
expanded Model in a future year. We note that any measure removals
would be proposed in future notice and comment rulemaking.
We request public feedback on this future consideration.
(2) Health Equity Considerations for the Expanded HHVBP Model
In section VIII.B. of this proposed rule, we include a Request for
Information on ways to close the health equity gap in post-acute care
quality reporting programs, including the HH QRP. We refer readers to
that section for discussion of our current health equity efforts in
quality measurement and reporting and potential modifications we have
considered or may consider in the future. However, in recognition of
persistent health disparities and the importance of closing the health
equity gap, we request public comment on ways in which we could
incorporate health equity goals and principles into the expanded HHVBP
Model. Specifically, we seek comment on the challenges unique to value-
based purchasing frameworks in terms of promoting health equity, and
ways in which we could incorporate health equity goals into the
expanded HHVBP Model.
f. Measure Submissions--Form, Manner, and Timing
We propose at 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 previously, the expanded HHVBP Model measures in the
proposed measure set beginning with the CY 2022 performance year would
use data currently already reported by HHAs. The proposed measure set
includes OASIS \22\ measures, submitted through the OASIS assessment,
which is required to be submitted as part of the Medicare Conditions of
Participation (CoPs), the HHCAHPS survey measure, which is required
under the HH QRP, and claims-based measures, which are calculated by
CMS based on claims data HHAs already submit for purposes of payment.
In many cases, measures from the expanded HHVBP Model overlap with
those in the HH QRP, and HHAs would only need to submit data once to
fulfill requirements of both. However, as described in section III.6.a.
of this proposed rule, in the future we may propose new measures that
may not otherwise already be collected or submitted by HHAs.
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\22\ 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 request comment on our proposal.
(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) \23\ 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 (initial assessment) or Resumption of Care OASIS
assessment and a Transfer or Discharge OASIS
[[Page 35930]]
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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\23\ 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 are proposing that HHAs participating in the expanded HHVBP
Model would also be required to submit OASIS data according to the
requirements of the CMS home health regulations codified at Sec.
484.250(a) and OASIS data described in Sec. 484.55(b), (c) and (d). If
finalized, this would mean that HHAs would not be required to submit
additional data through OASIS specifically for the expanded Model
compared to what is already required for COPs, and there would be no
additional burden. We note that this proposed requirement also aligns
with requirements under the Home Health QRP (82 FR 4578).
For the expanded Model, we propose that the underlying source data
used to calculate an OASIS quality measure score beginning with the CY
2022 performance year comes from 12 months of OASIS assessment data
from the applicable performance period via iQIES. The data extracted
from iQIES for all OASIS measures, besides the two TNC measures, are
aggregated to the monthly level for each HHA, separated by observed and
predicted values used to calculate risk adjusted values. For the two
TNC measures, we propose to use raw OASIS assessments to calculate
applicable measure scores consistent with how we developed these
measures.
We request comment on our proposals.
(2) Form, Manner, and Timing of HHCAHPS Survey Measure Data
Under the HH QRP, HHAs are required to contract with an approved,
independent HHCAHPS survey vendor to administer the HHCAHPS on its
behalf (42 CFR 484.245(b)(1)(iii)(B)) among other requirements.
For purposes of the expanded HHVBP Model, we propose similar
requirements that align with the HH QRP HHCAHPS survey measure data
reporting requirement at 484.245(b)(1)(iii). Specifically, under the
expanded Model we propose that--
HHAs must contract with an approved, independent HHCAHPS
survey vendor to administer the HHCAHPS survey on its behalf;
CMS approves an HHCAHPS survey vendor if the applicant has
been in business for a minimum of 3 years and has conducted surveys of
individuals and samples for at least 2 years;
A ``survey of individuals'' is defined as the collection
of data from at least 600 individuals selected by statistical sampling
methods and the data collected are used for statistical purposes;
No organization, firm, or business that owns, operates, or
provides staffing for an HHA is permitted to administer its own HHCAHPS
Survey or administer the survey on behalf of any other HHA in the
capacity as an HHCAHPS survey vendor. Such organizations are not be
approved by CMS as HHCAHPS survey vendors;
Approved HHCAHPS survey vendors must fully comply with all
HHCAHPS survey oversight activities, including allowing CMS and its
HHCAHPS survey team to perform site visits at the vendors' company
locations; and
Patient count exemption: HHAs that have fewer than 60
eligible unique HHCAHPS survey patients must annually submit to CMS
their total HHCAHPS survey patient count to CMS to be exempt from the
HHCAHPS survey reporting requirements for a calendar year.
A CMS contractor provides the agency with the HHCAHPS survey
measure score aggregated to the 12-months of data for the applicable
performance period.
The list of approved HHCAHPS survey vendors is available at https://homehealthcahps.org or contact the HHCAHPS help desk [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 propose to codify these proposals at Sec.
484.355(a)(1)(ii).
We request public comment on these proposals.
(3) Form, Manner, and Timing of Claims-Based Measures
Claims-based measures are derived from claims data submitted to CMS
for payment purposes. Claims-based utilization measures provide
information related to the use of health care services (for example,
hospitals, emergency departments, etc.) resulting from a change in
patient health status. We calculate claims-based measures based on
claims data submitted to CMS for payment purposes. Therefore, HHAs do
not need to submit additional information for purposes of calculating
claims-based measures.
We propose that the underlying source data for claims-based
measures is 12 months of claims data during the applicable performance
period for purposes of payment under the expanded Model.
We request comment on our proposal.
(4) Proposed Data Reporting for Monitoring and Evaluation of the
Expanded HHVBP Model
Consistent with requirements under the original HHVBP Model atSec.
484.315(c), we propose that competing HHAs under the expanded HHVBP
Model would be required to collect and report information to CMS
necessary for the purposes of monitoring and evaluating this model as
required by statute.\24\ We also propose to codify this at Sec.
484.355(b).
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\24\ See 1115A(b)(4) of the Act (42 U.S.C. 1315a).
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We seek public comment on these proposals.
(5) Proposal To Use Authority Under Section 1115A(d)(1) of the Act To
Waive Provisions Outlined in 1890A(a)(1) and (3) Through (6) of the Act
In section III.A.11. of this proposed rule, we propose a public
reporting framework for the expanded HHVBP Model that would include
annual public reporting of quality performance data. This data includes
national benchmarks and achievement thresholds, HHA-level performance
results for HHAs that qualify for an annual payment adjustment that
includes applicable quality measure scores, Total Performance Scores
and percentile rankings, improvement thresholds, and payment adjustment
percentages. Section 1890A(a)(1) through (6) of the Act set forth
requirements regarding the pre-rulemaking process for the selection of
quality and efficiency measures described in section 1890(b)(7)(B) of
the Act, including quality and efficiency measures used in reporting
performance information to the public. We are proposing to utilize the
Center for Medicare and Medicaid Innovation's waiver authority under
section 1115A(d)(1) of the Act to waive the steps outlined in section
1890A(a)(1) and (3) through (6) of the Act that
[[Page 35931]]
pertain to the pre-rulemaking process for publicly reporting
performance information to the extent necessary to test the proposed
expanded Model.
Section 1115A(d)(1) of the Act allows the Secretary to waive
certain statutory requirements ``as may be necessary solely for
purposes of carrying out this section with respect to testing models
described in subsection (b).'' Specifically, we propose to waive
section1890A(a)(1) and (3) through (6) of the Act which pertains to:
Convening multi-stakeholder groups to provide input to the Secretary on
the use of quality and efficiency measures; transmitting the input from
the 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 are not proposing 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 are proposing to waive the steps outlined in sections
1890A(a)(1) and (3) through (6) of the Act to the extent necessary in
order to allow maximum flexibility to continue to test the expanded
HHVBP Model under authority of section 1115A of the Act. The timeline
associated with completing the steps described by these provisions
would impede our ability to support testing new measures in a timely
fashion, as well as testing new ways to incentivize quality performance
in the home health setting and a new way to pay for home health care
services. We plan to continue to seek input from a Technical Expert
Panel (TEP) and to monitor quality measure performance to inform
potential measure set changes under the expanded Model. Waiving the
five steps noted previously for the expanded HHVBP Model would allow
for a more flexible timeline with more timely evaluation and monitoring
of quality performance and results.
Flexibility in timing to adjust the quality measure set and/or
methodology to respond to unexpected events and trends in home health
care, as well as to respond timely to any stakeholder concerns, is
critical to the success of the HHVBP Model expansion. The ongoing
uncertainty levied by the COVID-19 pandemic, and similar events that
may come in the future, requires us to maintain responsiveness to
anomalies in the quality measure data. These challenges may require the
flexibility to timely implement changes to ensure that measure sets
continue to appropriately assess performance in light of external
factors. In addition, trends in market consolidation and small business
policies in the home health care industry could require certain
adjustments to measure methodology, that is, minimum volume
requirements, or require adjustment to the applicability of measures.
The home health care sector is also becoming a more important source of
care for beneficiaries who prefer to age in the community, rather than
in an institution. This trend, in addition to the national shift in
beneficiary demographics, could require flexibility in the quality
measure set. This flexibility would be a key lever to adapt the Model
to the unpredictable changes led by beneficiary preference, industry
trends, and unforeseen nationwide events that HHAs are particularly
sensitive to. We seek comment on our proposal to waive the steps
outlined in section 1890A(a)(1) and (3) through (6) of the Act as
applicable and to the extent necessary to test the proposed expanded
Model.
7. Proposed Performance Scoring Methodology
a. Considerations for Developing the Proposed Total Performance Score
Methodology
We considered several factors when we initially developed and
subsequently refined the performance scoring methodology over the
course of the original Model, and we are proposing to apply a similar
methodology for the expanded HHVBP Model. We explain later in this
section how we propose to calculate a ``performance score'' for each
applicable measure for each competing HHA, which is defined as the
achievement or improvement score (whichever is greater). The ``Total
Performance Score,'' or ``TPS,'' is the numeric score, ranging from 0
to 100, awarded to each qualifying HHA based on the weighted sum of the
performance scores for each applicable quality measure under the HHVBP
Model expansion. The following principles guided the original Model's
design, as well as these proposals for the expanded Model.
First, we believe the performance scoring methodology should be
straightforward and transparent to HHAs, beneficiaries, and other
stakeholders. HHAs should be able to clearly understand performance
scoring methods and performance expectations to optimize quality
improvement efforts. The public should also understand performance
score methods to utilize publicly-reported information when choosing
HHAs.
Second, we believe the performance scoring methodology for the
proposed HHVBP Model expansion should be aligned appropriately with the
quality measurements adopted for other Medicare value-based purchasing
programs, including those introduced in the hospital and skilled
nursing home settings. This alignment would facilitate the public's
understanding of quality measurement information disseminated in these
programs and foster more informed consumer decision-making about their
health care choices.
Third, we believe that differences in performance scores must
reflect true differences in performance. To make sure that this point
is addressed in the performance scoring methodology for the proposed
HHVBP Model expansion, we assessed quantitative characteristics of the
measures, including the current state of measure development, number of
measures, and the number and grouping of measure categories.
Fourth, we believe that both quality achievement and improvement
must be measured appropriately in the performance scoring methodology
for the expanded HHVBP Model. The proposed methodology specifies that
performance scores under the expanded HHVBP Model would be calculated
utilizing the higher of achievement or improvement scores for each
measure, with achievement out of 10 points and improvement out of 9. We
considered the impact of performance scores utilizing achievement and
improvement on HHAs' behavior and the resulting payment implications.
As under the original Model, using the higher of achievement or
improvement scores would allow the Model expansion to recognize HHAs
that have made improvements, though their measured performance score
may still be relatively lower in comparison to other HHAs. By limiting
the improvement score to a scale across 0 to 9, we prioritize
achievement relative to improvement.
Fifth, we intend that the expanded Model would utilize the most
currently available data to assess HHA performance, to the extent
appropriate and feasible within the current technology landscape. We
recognize that not all HHAs have the ability to submit data
electronically or digitally
[[Page 35932]]
and that the proposed quality measure data would not be available
instantaneously due to the time required to collect, submit, and
process quality measurement information accurately; however, we intend
to process data as efficiently as possible.
b. Proposed Performance Score Methodology
(1) Overview
The goal of the performance scoring methodology would be to produce
a TPS for each qualifying HHA based on its raw scores on each
applicable quality measure included in the expanded HHVBP Model. We
would then use the HHA's TPS to determine the HHA's payment adjustment
percentage. At a high level, the following summarizes the proposed
steps for determining an HHA's TPS under the expanded Model, which is
similar to the approach used under the original Model: (1) Each HHA
would receive a raw quality measure score for each applicable measure
during the performance year; (2) the HHA would receive an ``achievement
score'' for each applicable measure, which is defined as a numeric
value between 0 and 10 that quantifies an HHA's performance on a given
quality measure compared to other HHAs in the same cohort in the
baseline year (calculated using the achievement threshold and
benchmark, as defined in section III.A.7.b.2. of this proposed rule);
(3) each HHA would also receive an ``improvement score'' for each
applicable measure, which is defined as a numeric value between 0 and
9, that quantifies an HHA's performance on a given quality measure
compared to its own individual performance in the baseline year (the
improvement threshold, as defined in section III.A.7.b.2. of this
proposed rule); (4) each HHA would be assigned a ``performance score''
on each applicable measure that is the higher of the achievement score
or the improvement score, as described in section III.A.7.b.2 of this
proposed rule; and (5) each performance score would then be weighted,
using each measure's assigned weight, and summed to generate the HHA's
TPS, as described in section III.A.7.e. of this proposed rule. The
result of this process would be a TPS for each competing HHA that can
be translated into a payment adjustment percentage using the LEF
applicable to each cohort, as described in section III.A.8. of this
proposed rule.
Our proposal for the performance scoring methodology under the
expanded HHVBP Model follows closely to that of the original Model. As
discussed in more depth in the sections that follow, under the expanded
HHVBP Model, we propose that we would assess each HHA's TPS based upon
all applicable quality measures (defined below) in the expanded Model
measure set in the applicable performance year. Each competing HHA
would receive an interim assessment on a quarterly basis, as described
in detail in section III.A.9.a. of this proposed rule. The performance
scoring methodology would be used to determine an annual distribution
of value-based payment adjustments among HHAs in a cohort so that HHAs
achieving the highest performance scores would receive the largest
upward payment adjustment. The proposed methodology includes three
primary features, each of which is discussed in more detail in the
sections that follow:
The HHA's TPS would reflect all of the claims- and OASIS-
based measures for which the HHA meets the minimum of 20 home health
episodes of care per year and all of the individual components that
compose an HHCAHPS survey measure for which the HHA meets the minimum
of 40 HHCAHPS surveys received in the performance year, defined as
``applicable measures''.
An HHA's TPS would be determined by weighting and summing
the higher of that HHA's achievement or improvement score for each
applicable measure as described in section III.A.7.b. of this proposed
rule.
The claims-based, OASIS assessment-based, and the HHCAHPS
survey-based measure categories would be weighted 35 percent, 35
percent, and 30 percent, respectively, and would account for 100
percent of the TPS. If an HHA is missing a measure category or a
measure within the OASIS-based measure category, the measures would be
reweighted, as described further in section III.A.7.e. of this proposed
rule.
As noted, we are proposing that many of the key elements from the
original Model's performance scoring methodology would also apply for
the expanded HHVBP Model, as we discuss in more detail in the sections
that follow. The primary changes between the original Model and the
expanded Model would be that first, because we are not proposing to
require submission of the New Measures data, we would not consider New
Measures in calculating the TPS under the expanded Model. The New
Measures reporting currently accounts for 10 percent of the TPS under
the original HHVBP Model. In addition, we are proposing small changes
to the achievement and improvement score formulas to simplify their
calculation and interpretation, without materially changing the output.
We are also proposing to calculate benchmarks and achievement
thresholds based on national 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 proposed rule. Finally, we are proposing to change the potential
score range for the TNC Mobility and TNC Self-Care measures from 0 to
15 points for achievement and 0 to 13.5 points for improvement as under
the original Model, to 0 to 10 points for achievement and 0 to 9 points
for improvement in the expanded Model. This change simplifies and
aligns the calculation of the composite measure scores. The proposed
weighting in the expanded Model, which follows the original Model,
accounts for the intended increase in relative contribution from these
composite measures to the TPS.
(2) Proposed Calculation of the Benchmark and Achievement Threshold
For scoring HHAs' performance on measures in the claims-based,
OASIS-based, and the HHCAHPS survey-based categories, we propose
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 proposed in section III.A.5.b.1.
of this proposed rule, with the exception of new HHAs, the baseline
year would be CY 2019 (January 1, 2019 through December 31, 2019) for
the CY 2022 performance period/CY 2024 payment year and subsequent
years. All benchmarks and achievement thresholds would be set based on
HHA performance in the designated baseline year.
We propose that to determine achievement points for each measure,
HHAs would receive points along an achievement range, which is a scale
between the achievement threshold and a benchmark. We propose to define
the ``achievement threshold'' as the median (50th percentile) of all
HHAs' performance scores on the specified quality measure during the
baseline year, calculated separately for the larger- and smaller-volume
cohorts. We propose to calculate the benchmark as the mean of the top
decile of all HHAs' performance scores on the specified quality measure
during the baseline year, calculated separately for the larger- and
smaller-volume cohorts. Unlike the original Model, for the expanded
HHVBP Model, we are proposing to use
[[Page 35933]]
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 proposed
rule. We also propose that to determine improvement points for each
measure, HHAs would receive points along an improvement range, which is
a scale between an HHA's performance during the baseline year and the
benchmark. The HHA's baseline year score is termed the ``improvement
threshold.'' The benchmark is the same benchmark used in the
achievement calculation. The achievement threshold and benchmarks for
each cohort, and the improvement threshold for each HHA, calculated
using baseline year performance scores, would be provided to the HHAs
as soon as feasible. In addition, benchmarks, achievement thresholds,
and improvement thresholds for each measure would be restated on each
HHA's interim performance report (IPR). We also propose to codify the
proposed definitions of achievement threshold, benchmark, and
improvement threshold at Sec. 484.345. We seek public comment on these
proposals.
(i) Proposed Calculation of Achievement Score
In the original Model, we calculated the achievement score by
dividing the difference between the HHA's performance score and the
achievement threshold by the difference between the benchmark and the
achievement threshold, multiplying the quotient by 9, and then taking
the product and adding 0.5 (80 FR 68681).
Under the expanded HHVBP Model, we propose a similar approach, but
with minor modifications intended to improve and simplify the
calculation and the interpretation of the achievement score. Under the
expanded Model, as under the original Model, we propose that an HHA
could earn between 0 to 10 achievement points for each applicable
measure based on its performance during the performance year relative
to other HHAs in its cohort in the baseline years, quantified by the
achievement threshold and the benchmark, as proposed in section
III.A.7.b.2. of this proposed rule. We propose to calculate the
achievement score using the following formula:
[GRAPHIC] [TIFF OMITTED] TP07JY21.042
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 propose that the
maximum achievement points would be capped at 10 achievement points. As
under the original Model, we propose to round each measure's
achievement points up or down to the third decimal point under the
expanded HHVBP Model. For example, an achievement score of 4.5555 would
be rounded to 4.556. This ensures precision in scoring and ranking HHAs
within each cohort. In determining an achievement score based on the
HHA's raw quality measure score, we propose to apply the following
rules to the achievement score calculation to ensure the achievement
score falls within the range of 0 to 10 points to align with the
simplified equation:
An HHA with a raw quality measure score greater than or
equal to the benchmark receives the maximum of 10 points for
achievement.
An HHA with a raw quality measure score greater than the
achievement threshold (but below the benchmark) receives greater than 0
but less than 10 points for achievement (prior to rounding), by
applying the achievement score formula.
An HHA with a raw quality measure score that is less than
or equal to the achievement threshold receives 0 points for
achievement.
We are proposing to no longer calculate the achievement scoring for
the TNC Self-Care and TNC Mobility measures out of 15 possible points,
as under the original Model, and to instead simplify and align the
calculation with other measures by calculating achievement scoring for
the composite measures out of 10 possible points. The proposed
weighting, consistent with the original Model, would already assign a
larger contribution from these composite measures to the overall OASIS
category score, as described in section III.A.7.e.(2).(iii). of this
proposed rule. We also propose to codify these proposals at Sec.
484.360. We seek public comment on these proposals.
(ii) Proposed Calculation of the Improvement Score
In the original Model, beginning with performance year 4, we
calculated improvement scores by dividing the difference between the
HHA's performance year score and the HHA's baseline year score by the
difference between the benchmark and the HHA's baseline year score,
multiplying the quotient by 9, and then taking the product and
subtracting 0.5 to calculate the improvement score (83 FR 56543).
Similarly, under the expanded HHVBP Model, we propose to allocate 0
to 9 improvement points to an HHA for each applicable measure based
upon how much an HHA's performance score in the performance year
improved relative to its performance score during the baseline year.
The expanded HHVBP Model aims to ensure that all HHAs provide high
quality care and awarding more points for achievement than for
improvement supports this goal. This continues to also align with the
HVBP Program, where hospitals can earn a maximum of 9 improvement
points if their measure score falls between the improvement threshold
and the benchmark (76 FR 26515).
We propose to establish a unique improvement range for each measure
and for each HHA that defines the difference between the HHA's baseline
year score (referred to as the ``improvement threshold'') and the
benchmark for the applicable measure, calculated for the applicable
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] TP07JY21.043
[[Page 35934]]
Relative to the original Model, this proposed equation is simplified,
for ease of calculation and interpretation, by no longer subtracting
0.5. Should the calculated points exceed 9, we propose that the maximum
improvement points would be capped at 9 improvement points. Like the
achievement points, we propose to round each measure's improvement
points up or down to the third decimal point under the expanded HHVBP
Model.
In calculating the improvement score based on the HHA's raw quality
measure score, we are proposing to apply the following rules to the
improvement score calculation to ensure the improvement score falls
within the range of 0 to 9 points to align with the simplified
equation:
If the HHA's raw quality measure score is greater than or
equal to the benchmark, the HHA would receive an improvement score of 9
points--an HHA with a raw quality measure score greater than or equal
to the benchmark could still receive the maximum of 10 points for
achievement.
If the HHA's raw quality measure score is greater than its
improvement threshold but below the benchmark (within the improvement
range), the HHA would receive an improvement score that is greater than
0 and less than 9 (before rounding) based on the improvement score
formula and as illustrated in the examples in the next section.
If the HHA's raw quality measure score is less than or
equal to or its improvement threshold for the measure, the HHA would
receive 0 points for improvement.
We are proposing to no longer calculate the improvement scoring for
the TNC Self-Care and TNC Mobility measures out of 13.5 possible
points, as under the original Model, and to instead simplify and align
the calculation with other measures by calculating improvement scoring
for the composite measures out of 10 possible points. The proposed
weighting, consistent with the original Model, would already assign a
larger contribution from these composite measures to the overall OASIS
category, as described in section III.A.7.e.(2).(iii). of this proposed
rule. We also propose to codify these proposals at Sec. 484.360. We
seek public comment on these proposals.
(iii) Examples of Calculating Achievement and Improvement Scores
For illustrative purposes, the following examples demonstrate how
the performance scoring methodology would be applied in the context of
the measures in the claims-based, OASIS-based, and the HHCAHPS survey-
based categories. These HHA examples are based on illustrative data
from CY 2019 (for the baseline year) and hypothetical data for CY 2022
(for the performance year). The benchmark calculated for the Dyspnea
measure is 97.676 for HHA A (calculated as the mean of the top decile
of HHA performance from the CY 2019 baseline year for the volume-based
cohort). The achievement threshold is 75.358 (calculated as the median
or the 50th percentile of HHA performance from the CY 2019 baseline
year for the same volume-based cohort).
Figure 4 shows the scoring for HHA `A' as an example. HHA A's CY
2022 performance year score for the Dyspnea measure was 98.348,
exceeding both the CY 2019 achievement threshold and benchmark, which
means that HHA A earned the maximum 10 points based on its achievement
score. Its improvement score is irrelevant in the calculation because
the HHA's performance score for this measure exceeded the benchmark,
and the maximum number of improvement points possible is 9.
Figure 4 also shows the scoring for HHA `B.' HHA B's performance on
the Dyspnea measure was 52.168 for the CY 2019 baseline year (HHA B's
improvement threshold) and increased to 76.765 (which is above the
achievement threshold of 75.358) for the CY 2022 performance year. To
calculate the achievement score, HHA B would earn 0.630 achievement
points, calculated as follows: 10 * (76.765-75.358)/(97.676-75.358) =
0.630.\25\ Calculating HHA B's improvement score yields the following
result: Based on HHA B's period-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.\26\ Because the higher of the achievement and
improvement scores is used, HHA B would receive 4.864 improvement
points for this measure.
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\25\ The proposed formula for calculating achievement points is
10 * (HHA Performance Year Score-Achievement Threshold)/(Benchmark-
Achievement Threshold).
\26\ The proposed formula for calculating improvement points is
9 * (HHA Performance Year Score-HHA Improvement Threshold)/(HHA
Benchmark-HHA Improvement Threshold).
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In Figure 5, HHA `C' yielded a decline in performance on the TNC
Self-Care measure, falling from 70.266 to 58.487. HHA C's performance
during the performance year was lower than the achievement threshold of
75.358 and, as a result, HHA C would receive zero points based on
achievement. It would also receive zero points for improvement because
its performance during the performance year was lower than its
improvement threshold.
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TP07JY21.044
[[Page 35936]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.045
BILLING CODE 4120-01-C
c. Minimum Threshold Number of Cases for Claims-Based, OASIS-Based, and
HHCAHPS Survey-Based Measures To Receive a Measure Score
For the expanded Model, we are proposing to apply the same policies
around minimum case counts for each measure as implemented under the
original Model, as described in proposed Sec. 484.345. We propose to
continue to award an HHA the higher-of achievement or improvement
points, as proposed 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 are
proposing this minimum to align with the original HHVBP Model and the
measure specifications used for the Patient Quality of Care Star
Ratings.\27\ For the individual components that compose the HHCAHPS
survey measure, an ``applicable measure'' means a component for which a
competing HHA has submitted a minimum of 40 completed HHCAHPS surveys.
A minimum of 40 completed HHCAHPS surveys for each applicable measure
for the expanded Model represents a balance between providing
meaningful data for payment adjustments and having more HHAs with
sufficient numbers of measures with performance scores. Moreover, using
a minimum of 40 completed HHCAHPS surveys for each applicable measure
would align with the Patient Survey Star Ratings on Home Health
Compare.\28\
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\27\ 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.
\28\ 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.
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We also propose to codify this proposed definition of an
``applicable measure'' at Sec. 484.345. We seek public comment on
these proposals.
d. Minimum Number of Applicable Measures for an HHA To Receive a Total
Performance Score
For the expanded Model, we are proposing to apply the same policies
around the minimum number of applicable measures to receive a TPS, as
implemented under the original Model. We are proposing that, beginning
with the CY 2022 performance year and for subsequent years, an HHA that
does not meet the minimum threshold of cases or completed HHCAHPS
surveys, as applicable, on five or more measures under the expanded
Model would not receive a TPS or a payment adjustment based on that
performance year. Under the expanded Model, this means 5 of the 12
possible applicable measures in the measure set, which includes two
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 believe that a minimum of five applicable measures
allows for a robust basis on which to adjust payment while also
maximizing the number of HHAs eligible for the payment adjustment.
Although those HHAs that do not meet this minimum would not be
subject to payment adjustments under the expanded Model, we propose
that other applicable policies under the expanded HHVBP Model would
still apply. We propose that these HHAs
[[Page 35937]]
would receive IPRs for any measures that meet the definition of
applicable measure, and they would continue to have future
opportunities to compete for payment adjustments. Based on the most
recent data available, the vast majority of HHAs are reporting on at
least five applicable measures. In 2019, those with less than five
applicable measures account for less than 2.4 percent of the claims
made (and 2.0 percent of claims payments made) across the 9,526 HHAs
delivering care nationwide.
We also propose to codify this proposal at Sec. 484.360(c). We
seek public comment on this proposal.
e. Proposed Weights for the Claims-Based, OASIS-Based, and HHCAHPS
Survey Measures
Except for removing the New Measures category, for the expanded
HHVBP Model, we are generally proposing the same policies regarding the
weighting of measures and the re-distribution of weights when measures
or measure categories are missing as under the original Model (83 FR
56536).
(1) Proposed Weighting and Re-Distribution of Weights Between the
Measure Categories
In this proposed rule, we propose to group the expanded Model
proposed measures into measure categories based on their data source as
indicated in Table 28: Claims-based, OASIS-based, and the HHCAHPS
survey-based. We propose that claims-based, 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 propose that where an HHA is missing all measures from a
single measure category, the weights for the remaining two measure
categories would be redistributed such that the proportional
contribution remains consistent with the original weights. For
instance, some smaller-volume HHAs may be missing the HHCAHPS survey
measure, which would require 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.29 30 Finally, we propose that if two
measure categories are missing, the remaining category would be
weighted 100 percent. We refer readers to Table 29 for the distribution
of measure category weights under various scenarios.
---------------------------------------------------------------------------
\29\ OASIS-based measures reweighting = 35% original OASIS
weight/(35% original OASIS weight + 30% original HHCAHPS weight) =
53.85% revised OASIS weight.
\30\ HHCAHPS reweighting = 30% original HHCAHPS weight/(35%
original OASIS weight + 30% original HHCAHPS weight) = 46.15%
revised HHCAHPS weight.
---------------------------------------------------------------------------
(2) Proposed Quality Measure Weights Within Measure Categories
Within the measure categories, we are proposing to weight certain
individual measures differently than other measures in the same
category.
(i) HHCAHPS Survey Measure Category
For the HHCAHPS survey measure category, we propose that all five
components are weighted equally to determine the overall HHCAHPS survey
measure percentage, which would contribute 30 percent to the overall
TPS. This measure category would not require re-distribution of weights
for the individual components because HHAs either meet the minimum
requirement for number of completed surveys for all HHCAHPS survey
measure components or they do not meet the minimum requirements.
(ii) Claims-Based Measure Category
For the claims-based measure category, we are proposing to weight
the ACH measure at 75 percent, and the ED Use measure at 25 percent of
the total measure weight for this measure category. We are proposing to
place a higher weight on the ACH measure because it reflects a more
severe health event and because inpatient hospitalizations generally
result in more Medicare spending than the average emergency department
visit that does not lead to an acute hospital admission. Like the
HHCAHPS survey measure components, an HHA would either have sufficient
volume for both claims-based measures to be applicable measures or it
would have data for neither measure since both measures require the
same minimum of 20 episodes per performance year. Consequently, 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 propose to weight both the
TNC Self Care and TNC Mobility measures at 25 percent each; and the
Dyspnea, Discharged to Community, and Oral Medications measures at
16.67 percent each of the total measure weight for this measure
category. Both the TNC Self-Care and TNC Mobility measures are composed
of several measures that are consolidated into two composite measures;
because of this, we are proposing to weight them slightly more than the
other three measures, which are not composite measures, as under the
original Model. Under this proposal, should any measures in the
category be missing, we propose to re-distribute weights across the
measures such that the original proportions are maintained. For
instance, should an HHA be missing both the TNC Self-Care and Dyspnea
measures, the remaining measures would be weighted as 42.85 percent for
the TNC Mobility measure, 28.57 percent for the Discharged to Community
measure, and 28.57 percent for the Oral Medications measure, which
reflects the relative ratios of 25 percent to 16.67 percent to 16.67
percent, respectively.31 32 33
---------------------------------------------------------------------------
\31\ 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.
\32\ Discharged to Community reweighting = 16.67% original
Discharged to Community weight/(25% original TNC Mobility weight +
16.67% original Discharged to Community weight + 16.67% original
Oral Medications weight) = 28.57% revised Discharged to Community
weight.
\33\ 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 28 for a comprehensive list of the proposed within-
category measure weights.
[[Page 35938]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.046
Table 29 presents the proposed weights for the proposed measures
and measure categories under various reporting scenarios.
[GRAPHIC] [TIFF OMITTED] TP07JY21.047
We also propose to codify these proposals at Sec. 484.360. We seek
public comment on these proposals.
f. Examples of the Total Performance Score Calculation
The following are two examples of the proposed performance score
calculation, beginning with the assigned achievement vs. improvement
points. The following describes the TPS calculations for HHA ``D'' and
HHA ``E.''
In this first example, out of a possible 12 applicable measures,
which includes two claims-based measures, five OASIS assessment-based
measures, and five components that make up the HHCAHPS survey measure,
HHA ``D'' has at least 20 episodes of care and received at least 40
completed HHCAHPS surveys in the 12-month performance year, which means
the HHA received scores on all 12 quality
[[Page 35939]]
measures. Under the proposed scoring methodology outlined previously,
for HHA D, the measure category weights would be as follows: 35 percent
for the claims-based measures, 35 percent for the OASIS assessment-
based measures, and 30 percent for the HHCAHPS Survey-based measures.
See Table 30 for a detailed calculation of the TPS. For each measure in
column 1, HHA D receives the highest of its achievement or improvement
score, which is listed in column 2. Each applicable measure's weight is
listed in column 3. To determine the weighted points in column 4,
multiply the measure score in column 2 by the measure's weight in
column 3 and then by 10. The total performance score is the sum of all
the weighted points listed in column 4. In the case of HHA D, the TPS
is 46.021.
[GRAPHIC] [TIFF OMITTED] TP07JY21.048
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% 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 35940]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.049
8. Proposed Payment Adjustment Methodology
We finalized the use of the Linear Exchange Function (LEF) for the
original Model (80 FR 68686) because it was the simplest and most
straightforward option to provide the same marginal incentives to all
HHAs, and we believe the same to be true for the HHVBP Model expansion.
The LEF is used to translate an HHA's TPS into a percentage of the
value-based payment adjustment earned by each HHA. Performance
measurement is based on a linear exchange function which only includes
competing-HHAs.
Under the expanded HHVBP Model, we propose to codify at Sec.
484.370 a methodology for applying value-based payment adjustments to
home health services. We propose that payment adjustments would be made
to the HH PPS final claim payment amount as calculated in accordance
with HH PPS regulations at Sec. 484.205 using a LEF, similar to the
methodology utilized by the HVBP Program (76 FR 26533). We propose the
function's intercept at zero percent, meaning those HHAs that have a
TPS that is average in relationship to other HHAs in their cohort would
not receive any payment adjustment. Under this proposal, payment
adjustments for each HHA with a score above zero percent would be
determined by the slope of the LEF. We propose to set the slope of the
LEF for the given performance year so that the estimated aggregate
value-based payment adjustments for that performance year are equal to
5% (the proposed maximum payment adjustment for CY 2024) of the
estimated aggregate base operating payment amount for the corresponding
payment year, calculated separately for the larger and smaller volume
cohorts nationwide. The estimated aggregate base operating payment
amount is the total amount of payments made to all the HHAs by Medicare
nationwide in each of the larger- and smaller-volume cohorts.
We propose that the LEF would be calculated using the following
steps, after calculating and ranking the Total Performance Score (TPS)
(the range of the TPS is 0-100) for each HHA in the cohort:
Step 1, Determine the `Prior Year Aggregate HHA Payment
Amount' that each HHA was paid in the prior year.
Step 2, Determine the `X-percent (the applicable payment
year payment adjustment percent) Payment Reduction Amount' by
multiplying the Prior Year Aggregate HHA Payment Amount per HHA by the
`X-percent Reduction Rate'; the sum of these amounts is the numerator
of the LEF.
Step 3, Determine the `TPS Adjusted Reduction Amount' by
multiplying the `X-percent Payment Reduction Amount' by the TPS/100 .
The sum of these amounts is the denominator of the LEF.
Step 4, Calculate the LEF by dividing the sum of all HHAs'
`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 32 provides an example of how the LEF would be calculated and
how it would be applied to calculate the percentage payment adjustment
to an HHA's TPS. For this example, we applied the maximum 5-percent
payment adjustment proposed for the expanded HHVBP Model for the CY
2024 payment year.
[[Page 35941]]
Step #1 involves the calculation of the `Prior Year Aggregate HHA
Payment Amount' (C2 in Table 32) that each HHA was paid from claims
data under the HH PPS in the year prior to the performance year. For
the CY 2024 payment year, from claims data, all payments are summed
together for each HHA for CY 2021, the year prior to the performance
year.
Step #2 involves the calculation of the `5-percent Payment
Reduction Amount' (C3 of Table 32 for each HHA, which is calculated by
multiplying the `Prior Year Aggregate HHA Payment Amount', from Step #1
by the `5-percent Payment Reduction Rate'. The aggregate of the `5-
percent Payment Reduction Amount' is the numerator of the LEF.
Step #3 involves the calculation of the `TPS Adjusted Reduction
Amount' (C4 of Table 32) by multiplying the `5-percent Payment
Reduction Amount' from Step #2 by the TPS (C1) divided by 100. The
aggregate of the `TPS Adjusted Reduction Amount' is the denominator of
the LEF.
Step #4 involves calculating the LEF (C5 of Table 32) by dividing
the sum of `5- percent Payment Reduction Amount' calculated in Step #2
by the sum of `TPS Adjusted Reduction Amount' calculated in Step #3.
Step #5 involves the calculation of the `Final TPS Adjusted Payment
Amount' (C6 of Table 32) by multiplying the `TPS Adjusted Reduction
Amount' from Step #3 (C4) by the LEF from Step #4 (C5). The `Final TPS
Adjusted Payment Amount' is an intermediary value used to calculate
`Quality Adjusted Payment Rate'.
Step #6 involves the calculation of the `Quality Adjusted Payment
Rate' (C7 of Table 32) by dividing the `Final TPS Adjusted Payment
Amount' from Step #5 by the `Prior Year Aggregate HHA Payment Amount'
from Step #1. This is an intermediary step to determining the payment
adjustment rate.
Step #7 involves the calculation of the `Final Percent Payment
Adjustment' (C8 of Table 32) by subtracting 5 percent from `Quality
Adjusted Payment Rate'. The `Final Percent Payment Adjustment' would be
applied to the HHA payments for the payment adjustment year. We propose
that the payment adjustment percentage would be capped at no more than
plus or minus 5 percent for the applicable performance year and the
payment adjustment would occur on the final claim payment amount for
the applicable payment year.
We also propose to codify this payment methodology policy at Sec.
484.370. We invite comments on this proposal.
[GRAPHIC] [TIFF OMITTED] TP07JY21.050
9. Performance Feedback Reports
We propose to use two types of reports that would provide
information on performance and payment adjustments under the expanded
HHVBP Model. These reports would mirror those we have distributed to
HHAs under the original Model.
a. Proposed Interim Performance Report
The first report is the Interim Performance Report (IPR) that would
be distributed to HHAs quarterly. The IPR would contain information on
the interim quality measure performance based on the 12 most recent
months of data available. The IPR would provide feedback to HHAs
regarding performance relative to quality measure achievement
thresholds and benchmarks and would provide competing HHAs the
opportunity to assess and track their performance relative to their
peers and their own past performance. HHAs would receive both a
preliminary and final version of the IPR each quarter. The Final IPR
would become available, as soon as administratively feasible, after the
preliminary IPR is distributed and after recalculation requests are
processed, in accordance with the process in section III.A.10. of this
proposed rule (Appeal Processes).
Beginning with the data collected during the first quarter of CY
2022 (that is, data for the period January 1, 2022 to March 31, 2022),
and for every quarter of the expanded HHVBP Model thereafter, we
propose to provide each HHA with an IPR that contains information on
its performance during the 12 most recent months of data available. We
propose to provide the 12 most recent months of data because the
[[Page 35942]]
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 expect to make the first IPR available in July 2022 and make IPRs
for subsequent quarters available in October, January, and April. The
July 2022 IPR would be the first IPR issued that includes CY 2022
performance year data for the first quarter quality measure performance
scores on the proposed OASIS-based measures and baseline data for the
HHCAHPS survey and claims-based measures. We propose that the IPRs
would include a competing HHA's expanded HHVBP Model-specific
performance results with a comparison to other competing HHAs within
its applicable nationwide cohort (larger- or smaller-volume). We
propose that the IPRs would be made available to each HHA through a CMS
data platform, such as the internet Quality Improvement and Evaluation
System (iQIES), and would include each HHA's relative estimated ranking
amongst its cohort along with measurement points and total performance
score based on the 12 most recent months of data available. We note
that the IPRs would likely differ from the final data used to assess
performance during a given performance year because the time periods
used to develop the IPR data (the 12 most recent months) would differ
from the actual performance years under the expanded Model (for
example, CY 2022 data used to determine CY 2024 payment adjustments).
These performance results would complement quality data sources
provided through the iQIES and other quality tracking systems possibly
being employed by HHAs to help drive quality improvement. The iQIES-
generated reports would provide quality data earlier than the expanded
HHVBP Model-specific performance reports (that is, IPR or Annual)
because 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 propose would consolidate the applicable performance measures
used in the expanded HHVBP Model, provide a peer-ranking to other
competing HHAs within the same volume-based cohort, and provide the TPS
based on the interim data. In addition, Model-specific performance
reports would provide the competing HHAs with a Scorecard and TNC
Change Reference. The TNC Change Reference data would help HHAs gauge
their performance on the individual OASIS items included in the two
composite measures. It would also tell HHAs the percentage of episodes
in which there was no change, positive change, or negative change for
each OASIS item. The Scorecard would help HHAs better understand how
each individual measure contributes to the TPS. For more information on
the accessibility and functionality of the iQIES, please reference the
iQIES manuals.\34\ We note that all quality measures, except for the
TNC Mobility and TNC Self-Care measures and the HHCAHPS survey measure,
in the proposed measure set for the CY 2022 performance year of the
expanded HHVBP Model are already made available in the iQIES. For the
HHCAHPS survey measure, HHAs can access their Data Submission Reports
on https://homehealthcahps.org under the ``For HHAs'' tab. We also
suggest HHAs contact their survey vendor regarding data on the HHCAHPS
survey measure.
---------------------------------------------------------------------------
\34\ iQIES manuals are available at https://qtso.cms.gov/software/iqies/reference-manuals.
---------------------------------------------------------------------------
We invite public comment on our proposals.
b. Proposed Annual TPS and Payment Adjustment Report
We propose that the second report, the Annual TPS and Payment
Adjustment Report (Annual Report), would be made available to each of
the competing HHAs in approximately August of each year preceding the
payment adjustment year, expected beginning in August 2023. We propose
to make the report available via a CMS data platform, such as the
iQIES. The Annual Report would focus primarily on the HHA's payment
adjustment percentage for the upcoming CY and include an explanation of
when the adjustment would be applied and how this adjustment was
determined relative to the HHA's performance scores. Each competing HHA
would receive its own confidential Annual Report viewable only to that
HHA. We propose that the Annual Report would have three versions: A
Preview Annual Report, a Preliminary Annual Report (if applicable), and
a Final Annual Report. We would make available to each competing HHA
the Preview Annual Report in approximately August of each year
preceding the calendar year for which the payment adjustment would be
applied. We propose that HHAs would have 15 days to review and request
recalculations in accordance with the proposed process discussed in
section III.A.10. of this proposed rule (Appeal Processes). For HHAs
that request a recalculation, we would make available a Preliminary
Annual Report as soon as administratively feasible after the
recalculation request is processed. If we do not receive a
recalculation request as a result of the Preview Annual Report, a
Preliminary Annual Report would not be issued. We propose that HHAs
that receive a Preliminary Annual Report would have 15 days to review
and submit a reconsideration request in accordance with the proposed
process discussed in section III.A.10. of this proposed rule (Appeal
Processes). As under the original Model, we propose to make available
the Final Annual Report after all reconsideration requests are
processed and no later than 30 calendar days before the payment
adjustment takes effect annually, both for those HHAs that requested a
reconsideration and all other competing HHAs.
Under this proposed approach, HHAs would be notified in advance of
the first annual total performance score and payment adjustment being
finalized for CY 2024. The total performance score and payment
adjustment would be based on the CY 2022 performance year (January 1,
2022 to December 31, 2022), with the first payment adjustment to be
applied to each HH PPS final claim payment amount as calculated in
accordance with HH PPS policies as codified at 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. As a sequential example, the second payment adjustment
would apply for services furnished January 1, 2025 through December 31,
2025, based on a full 12 months of the CY 2023 performance year.
Notification of the second pending payment adjustment would occur in
approximately August 2024 when the Preview Annual Report is issued,
followed by the Preliminary (if applicable) and Final Annual Reports,
as described previously.
Data related to performance on quality measures would continue to
be provided for the baseline year and all performance years of the
expanded
[[Page 35943]]
Model via a CMS data platform, such as the iQIES (this platform would
present and might archive the previously described IPR and Annual
Reports). Table 33 is a sample timeline showing the availability of
each expanded HHVBP Model-specific performance report and the data
included for the CY 2022 performance year and CY 2024 payment year.
[GRAPHIC] [TIFF OMITTED] TP07JY21.051
We seek public comment on our proposals related to the Interim
Performance and Annual Reports.
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 PPS
final rule for further discussion of the appeals process under the
original HHVBP Model (81 FR 76747 through 76750).
Under the expanded Model, we propose to use the same appeals
process as the original Model. We propose that competing HHAs be
provided the opportunity to appeal certain information provided in the
IPRs and the Annual Report, as discussed in more detail in the
following sections.
a. Proposed Recalculation Request Process
Under the expanded HHVBP Model, we propose that HHAs be provided
two separate opportunities to review scoring information and request
recalculations.
HHAs would have the opportunity to request a recalculation if a
discrepancy is identified due to a CMS error in calculations after
review of their: (1) Preliminary IPRs following each quarterly posting;
or (2) Preview Annual Report. Specifically, we propose that an HHA
would have 15 calendar days from the date either the Preliminary IPR or
the Preview Annual Report is provided to request a recalculation of
measure scores if it believes there is evidence of a discrepancy in the
calculation of the measure. We propose that we would adjust the score
if it is determined that the discrepancy in the calculated measure
scores was the result of our failure to follow measurement calculation
protocols. An HHA would also have the opportunity to request
recalculation if it wishes to dispute the application of the formula to
calculate the payment adjustment percentage.
Under this proposal, for both the Preliminary IPRs and the Preview
Annual Report, competing HHAs would only be permitted to request
scoring recalculations or, for the Preview Annual Report, to dispute
the application of the formula used to calculate the payment adjustment
percentage, and must include a specific basis for the requested
recalculation. Any changes to underlying measure data cannot be made.
We would not provide HHAs with the underlying source data utilized to
generate performance measure scores.
We propose that HHAs that choose to request a recalculation would
submit recalculation requests for both quarterly Preliminary IPRs and
for the Preview Annual Reports via instructions provided on a CMS web
page. We propose that the request form would be entered by the primary
point of contact, a person who has authority to sign on behalf of the
HHA.
We propose that recalculation requests (quarterly Preliminary IPR
or Preview Annual Report recalculations)
[[Page 35944]]
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 web page.
Following receipt of a recalculation request, we propose that CMS
or its agent would--
Provide an email acknowledgement, using the contact
information provided in the recalculation request, to the HHA contact
notifying the HHA that the request has been received;
Review the request to determine validity, and determine
whether the requested recalculation results in a score change altering
performance measure scores or the HHA's TPS;
If the recalculation request results in a performance
measure score change, conduct a review of data and if an error is
found, recalculate the TPS using the corrected performance data; and
Provide a formal response to the HHA contact, using the
contact information provided in the recalculation request, notifying
the HHA of the outcome of the review and recalculation process. The
Final IPR and Preliminary Annual Report would reflect any changes noted
from recalculation process. As under the original Model, we anticipate
providing this response as soon as administratively feasible following
the submission of the request.
We are also proposing to codify the proposed recalculation process
at Sec. 484.375(a). We invite comment on our proposals.
b. Proposed Reconsideration Process
Under the expanded Model, we propose that if we determine that the
original calculation was correct and deny the recalculation request for
the scores presented in the Preview Annual Report, or if the HHA
otherwise disagrees with the results of a CMS recalculation as
reflected in the Preliminary Annual Report, the HHA may submit a
reconsideration request for the Preliminary Annual Report. We propose
that an HHA may request reconsideration of the outcome of a
recalculation request for its Preliminary Annual Report only. We
believe that the ability to review the IPRs and submit recalculation
requests on a quarterly basis provides competing HHAs with a mechanism
to address potential errors in advance of receiving their Preview
Annual Report. Therefore, we expect that in many cases, the
reconsideration request process proposed would result in a mechanical
review of the application of the formulas for the TPS and the LEF,
which could result in the determination that a formula was not
accurately applied.
Under this proposal, the reconsideration request and supporting
documentation would be required to be submitted via instructions
provided on the CMS web page within 15 calendar days of CMS'
notification to the HHA contact of the outcome of the recalculation
request for the Preview Annual Report. This proposed timeframe would
allow a decision on the reconsideration to be made prior to the
generation of the final data files containing the payment adjustment
percentage for each HHA and the submission of those data files to the
Medicare Administrative Contractors (MACs) to update their provider
files with the payment adjustment percentage. We believe that this
would allow for finalization of the annual performance scores, TPS, and
annual payment adjustment percentages in advance of the application of
the payment adjustments for the applicable performance year.
Reconsiderations would be conducted by a CMS designated official who
was not involved with the original recalculation request.
We propose that the final TPS and payment adjustment percentage be
provided to competing HHAs in a Final Annual Report no later than 30
calendar days in advance of the payment adjustment taking effect to
account for unforeseen delays that could occur between the time the
Annual Reports are posted and the appeals process is completed.
We are also proposing to codify the proposed reconsideration
process at Sec. 484.375(b).
We are soliciting comments on these proposals.
11. Public Reporting Under the Expanded HHVBP Model
a. Background
Consistent with our discussions on public reporting under the
original Model in prior rulemaking, in the CY 2020 HH PPS final rule
(84 FR 60552), we finalized a policy to publicly report on the CMS
website the following two points of data from the final CY 2020 Annual
Report for each participating HHA in the original Model that qualified
for a payment adjustment for CY 2020: (1) The HHA's TPS from
performance year 5; and (2) the HHA's corresponding performance year 5
TPS Percentile Ranking. We stated that these data would be reported for
each such competing HHA by agency name, city, State, and by the
agency's CCN (84 FR 60552 through 60553). We refer readers to section
III.B.3. of this proposed rule, where we are proposing to modify our
public reporting policy for the original Model, given our proposal in
section III.B.2. of this proposed rule to not use CY 2020 data to make
payment adjustments for CY 2022.
Publicly reporting performance data under the expanded Model would
enhance the current home health public reporting processes, as it would
better inform beneficiaries when choosing an HHA, while also
incentivizing HHAs to improve performance. It would also be consistent
with our practice of publicly reporting performance data under other
value-based initiatives such as the SNF VBP and HVBP Programs (42 CFR
413.338) (42 CFR 412.163). CMS publicly reports both facility-specific
SNF VBP Program performance information (such as achievement scores,
improvement scores, rankings, and incentive payment multipliers), as
well as aggregate-level program performance information on the CMS
website (42 CFR 413.338). Similarly, for the HVBP Program, CMS publicly
reports quality measures, baseline and performance years used, domain
scores, total performance scores, and aggregate payment adjustment
amounts on the CMS website (42 CFR 412.163).
Publicly reporting performance data for the expanded HHVBP Model
would also be consistent with other agency efforts to ensure
transparency and publicly report performance data. For example, the HH
QRP requires HHAs to submit data in accordance with 42 CFR
484.245(b)(1). Furthermore, section 1895(b)(3)(B)(v)(III) of the Act
requires, in part, that the Secretary establish procedures for making
certain HH QRP data available to the public. HHAs have been required to
collect OASIS data since 1999 and to report HHCAHPS data since 2012 (64
FR 3764 and 76 FR 68577). These data are available to providers,
consumers, beneficiaries, and other stakeholders on the Care Compare
Website.
[[Page 35945]]
b. Proposed Public Reporting for the Expanded Model
We believe that publicly reporting performance data under the
expanded HHVBP Model would be an important way of incentivizing HHAs to
improve quality performance under the Model. Therefore, we are
proposing to publicly report performance data for the expanded HHVBP
Model beginning with the CY 2022 performance year/CY 2024 payment
adjustment and for subsequent years. For all years of the expanded
HHVBP Model, we propose to publicly report the following information:
Applicable measure benchmarks and achievement thresholds
for each small- and large-volume cohort.
For each HHA that qualified for a payment adjustment based
on the data for the applicable performance year--
Applicable measure results and improvement thresholds;
The HHA's Total Performance Score (TPS);
The HHA's TPS Percentile Ranking; and
The HHA's payment adjustment for a given year.
We propose to report these data by State, CCN, and agency name
through a CMS website. We note that quality measure results for many of
the measures proposed to be included in the expanded HHVBP Model are
already currently reported on Care Compare; however, we are proposing
to also separately publicly report applicable measure results for such
measures in the expanded HHVBP Model, because the public reporting
periods for the Model would differ from those used for the HH QRP
public reporting on Care Compare. We believe this would be clear and
transparent for the public. In addition, to the extent that any new
measures or measures that are otherwise not included in the HH QRP and
are thus not already reported on Care Compare are included in the
expanded HHVBP Model in the future, we propose to publicly report those
measure results as well.
We would also provide definitions for the TPS and the TPS
Percentile Ranking methodology, as well as descriptions of the scoring
and payment adjustment methodology, on the CMS website to ensure the
public understands the relevance of these data points and how they were
calculated. We note that this information would include a broader range
of data elements than we previously finalized to publicly report for
the original HHVBP Model. We are proposing a broader range of data
elements for the expanded HHVBP Model for several reasons. First, this
publicly reported information would align more closely with the SNF VBP
and HVBP Programs, both of which publicly report a broad range of
information, including measure results and payment adjustment
percentages. Second, we note that measure results for those quality
measures included in the HH QRP are already publicly reported on the
Care Compare website. We believe that publicly reporting the
corresponding benchmarks for all expanded Model measures (including
those aligned with the HH QRP as well as measures that may not be), by
cohort, and other quality performance information for the expanded
HHVBP Model would further promote transparency and incentivize quality
improvements under the expanded Model.
We anticipate this information would be made available to the
public on a CMS website on or after December 1, 2023, the date by which
we would intend to complete the CY 2022 Annual Report appeals process
and issuance of the Final Annual Report to each competing HHA. For each
year thereafter, we anticipate following the same approximate timeline
for publicly reporting the payment adjustment for the upcoming calendar
year, as well as the related performance data as previously described.
As the expanded Model's performance data would be supplemental to
the Home Health Quality of Patient Care and Patient Survey Star
Ratings, and does not form a part of these or other star ratings, we
intend to also include a reference to the Home Health Star Ratings
available on the CMS website.
We also propose to codify these proposals at Sec. 484.355(c).
We seek public comment on these proposals.
12. Extraordinary Circumstances Exception Policy
The nation, its communities, and its health care providers, on
certain occasions, are forced to confront extreme and uncontrollable
circumstances outside of their control that impact their ability to
operate in the ordinary course of business for 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 propose to adopt an extraordinary
circumstances exception (ECE) policy for the expanded HHVBP Model that
aligns, to the extent possible, with the existing HH QRP exceptions and
extension requirements at 42 CFR 484.245(c). Section 484.245(c) permits
HHAs to request and CMS to grant an exception or extension from the
program's reporting requirements in the event of extraordinary
circumstances beyond HHAs' control.
Specifically, we are proposing that for the expanded HHVBP Model,
CMS may grant an exception with respect to quality data reporting
requirements in the event of extraordinary circumstances beyond the
control of the HHA. We are proposing that CMS may grant an exception as
follows:
An HHA that wishes to request an exception with respect to
quality data reporting requirements must submit its request to CMS
within 90 days of the date that the extraordinary circumstances
occurred. Specific requirements for submission of a request for an
exception would be available on the CMS website (cms.gov).
CMS may grant an exception to one or more HHAs that have
not requested an exception if: CMS determines that a systemic problem
with CMS data collection systems directly affected the ability of the
HHA to submit data; or if CMS determines that an extraordinary
circumstance has affected an entire region or locale.
We would strive to provide our formal response notifying the HHA of
our decision within 90 days of receipt of the HHA's ECE request,
however, the number of requests we receive and the complexity of the
information provided would impact the actual timeframe to make ECE
determinations. When an ECE for HHAs in the nation, region or locale is
granted, CMS would communicate the decision through routine channels to
HHAs and vendors, including, but not
[[Page 35946]]
limited to, the PAC QRP listserv, Open Door Forum MLN Connects, and
notices on the CMS Home Health Quality Reporting Spotlight webpage.
Specific instructions for requesting exceptions or extensions would be
provided on the CMS website.
We also propose to codify our ECE policy at Sec. 484.355(d).
We seek public comment on our proposals.
B. Provisions Under the Home Health Value-Based Purchasing (HHVBP)
Original Model
1. Background
The last year of data collection for the original Model ended on
December 31, 2020 and the last payment adjustment year of the original
Model would end on December 31, 2022. Payment adjustments are based on
each HHA's TPS in a given performance year, which is comprised of
performance on: (1) A set of measures already reported via the Outcome
and Assessment Information Set (OASIS),\35\ completed Home Health
Consumer Assessment of Healthcare Providers and Systems (HHCAHPS)
surveys, and select claims data elements; and (2) three New Measures
for which points are achieved for reporting data. Payment adjustments
for a given year are based on the TPS calculated for performance two
years' prior. Under current policy for the original Model, the CY 2022
payment adjustments would be based on CY 2020 (performance year 5)
performance. The maximum payment adjustment for CY 2022 is upward or
downward 8 percent.
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\35\ OASIS is the instrument/data collection tool used to
collect and report performance data by HHAs.
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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. Proposal on CY 2022 Payment Adjustments
For the reasons discussed in this section, we are proposing not to
use the CY 2020 (performance year 5) data for purposes of payment
adjustments under the HHVBP Model and to instead end the original Model
early, with the CY 2021 payment year. Specifically, we are proposing
that we would not use the annual TPS calculated using the performance
year 5 data to apply payment adjustments for CY 2022 and to instead end
the original Model early, such that HHAs in the nine original Model
States would not have their HH PPS claims payments adjusted by the
current maximum payment adjustment factor of upward or downward 8
percent in CY 2022.
In light of the data reporting exceptions under the HHVBP Model for
Q1 and Q2 2020 in response to the COVID-19 PHE, as discussed
previously, we reviewed available quality data from Q1 and Q2 2020 as
compared to Q1 and Q2 2019 for the nine original Model States to
determine whether it may be appropriate to use data from the time
period during which data reporting exceptions were in place (Q1 and Q2
2020). The comparison showed a decrease of 8.9 percent in OASIS
assessments. We could not directly compare HHCAHPS results from Q1 and
Q2 because our data are calculated on a 12-month rolling basis.
However, we also examined claims data during this same time period to
determine whether volume and utilization patterns changed and observed
a 20.2 percent decrease in claims-based home health stays in Q1 and Q2
2020 as compared to Q1 and Q2 2019. The change in volume and
utilization was observed across time (that is, the change was not
limited to a certain point of time during the Q1 and Q2 2020 time
period) and within and across States. We believe these changes could be
the result of the impacts of the COVID-19 PHE, including patients
avoiding care or dying, reduced discharges to the home, and increased
use of telehealth in lieu of in-person home health care. We also
observed a 10.5 percent decrease in New Measures data submissions for
Q1 and Q2 2020 as compared to Q1 and Q2 2019, consistent with what we
would expect given the New Measures reporting exceptions we issued for
this time period.
Based on the patterns we observed for the first two quarters of CY
2020, we do not believe it would be appropriate to utilize data from
that time period to calculate a TPS for CY 2020 that would
[[Page 35947]]
be used to make payment adjustments in CY 2022. The changes in volume
and utilization could skew performance assessments on quality measures
for HHAs, such that the calculated TPS may not accurately reflect the
quality of care provided by the HHAs. Additionally, we are concerned
that because the COVID-19 PHE has not impacted all HHAs equally,
implementing payment adjustments based on the impacted data for the
period of the COVID-19 PHE could unfairly penalize certain HHAs.
We also considered whether to use only Q3 and Q4 CY 2020 quality
measure data to calculate CY 2020 annual total performance scores for
CY 2022 payment adjustments. However, we believe that using only two
quarters of data may not be sufficiently representative of the care
provided by the HHA during a given calendar year for purposes of
calculating quality measure scores and determining payment adjustments
under the Model, and could potentially disadvantage those HHAs in an
area of a State more heavily affected by the pandemic in Q3 and Q4 of
CY 2020. In addition, as HHAs in different States continued to be
impacted by the COVID-19 PHE during the second half of CY 2020, we
believe patterns of home health care may also have continued to be
impacted during that timeframe, similar to the changes we observed for
the Q1 and Q2 2020 time period. As more data become available from the
latter half of CY 2020, we will continue to examine home health care
patterns in the nine original Model States in order to determine
whether the same patterns we observed in the Q1 and Q2 2020 data
persisted into the latter half of the year, and to assess whether it
would be appropriate to utilize such data for CY 2022 payment
adjustments. Finally, we note that several commenters on the exceptions
policies that we adopted in the May 2020 COVID-19 IFC requested that we
not use any performance data from CY 2020 and terminate or suspend the
original Model early (85 FR 70328 through 70330).
After consideration of these issues, we are proposing to not apply
any payment adjustments for CY 2022 of the original HHVBP Model based
on data reported in CY 2020 and to instead end the original Model
early, with the CY 2021 payment adjustment year. As noted, we will
continue to examine data for CY 2020 as it becomes available in order
to determine whether it would be appropriate to utilize such data for
CY 2022 payment adjustments, in accordance with current Model policies.
We will also continue to provide HHAs with the Interim Performance
Reports with CY 2020 performance data and the Annual Report with the
calculated TPS and payment adjustment amount based on the CY 2020
performance data, consistent with our current policies. If we finalize
our proposal, as previously discussed, we would not use the TPS
calculated using the performance year 5 data to apply payment
adjustments for CY 2022.
We note that if we finalize this proposal to end the original Model
early, the evaluation would include the period through CY 2019
(performance year 4) and CY 2021 (payment year 4). As we are proposing
to not use CY 2020 (performance year 5) data to calculate CY 2022
(payment year 5) payment adjustments, these years would not be
evaluated.
We believe that our proposed policy to not use CY 2020 performance
year data to determine payment adjustments under the HHVBP Model would
be consistent with how other quality reporting and VBP programs are
proposing to utilize data that has been significantly affected by
circumstances caused by the COVID-19 PHE. In the FY 2022 Hospice
proposed rule (86 FR 19755), we proposed to modify the HH QRP public
display policy to display fewer quarters of data than what was
previously finalized for certain HH QRP measures for the January 2022
through July 2024 refreshes (86 FR 19755 through 19764). For the
January 2022 refresh, data for OASIS-based and certain claims-based
measures would include Q3 2020 through Q1 2021 data. For HHCAHPS, data
would cover the four quarters Q3 2020 through Q2 2021. We note that Q1
2020 and Q2 2020 data would not be included in the proposed Care
Compare refresh schedule for any measures. The SNF VBP program proposed
in the FY 2022 SNF PPS proposed rule (86 FR 19954) to suppress the use
of the SNF readmission measure (SNFRM) for scoring and payment
adjustment purposes for the FY 2022 program year. The HVBP program
proposed in the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25469
through 25496) to suppress the use of a number of measures for the FY
2022 or FY 2023 program years for purposes of scoring and payment
adjustments, along with proposals to revise the baseline periods for
certain measures due to the extraordinary circumstances exception we
granted in response to the COVID-19 PHE.
We are proposing to amend at 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 invite public comment on our proposal.
3. Public Reporting Under the Original Model
In the CY 2020 HHS PPS final rule (84 FR 60551 through 60553), we
finalized a policy to publicly report on the CMS website the following
two points of data from the final CY 2020 performance year 5 Annual
Report for each participating HHA in the Model that qualified for a
payment adjustment for CY 2020: (1) The HHA's TPS from performance year
5; and (2) the HHA's corresponding performance year 5 TPS Percentile
Ranking. We stated that these data would be reported for each such
competing HHA by agency name, city, State, and by the agency's CMS
Certification Number (CCN). We expected that these data would be made
public after December 1, 2021, the date by which we intended to
complete the CY 2020 Annual Report appeals process and issuance of the
final Annual Report to each HHA.
For the reasons discussed in section III.B.2. of this proposed
rule, we are proposing to not use CY 2020 data for CY 2022 payment
adjustments under the HHVBP Model. Consistent with this proposal, we
are also proposing to modify our existing policy and not publicly
report performance data for the HHAs included in the original Model. We
do not believe that it would be appropriate to publicly report
performance data for a time period for which HHAs would not be held
financially accountable for quality, nor do we believe that reporting
data for this time period would assist beneficiaries and other public
stakeholders in making informed choices about HHA selection, as the
patterns of care during CY 2020 may not be representative of
performance under the original Model as a whole due to the COVID-19
PHE. However, as discussed in section III.A.11. of this proposed rule,
we are proposing to begin public reporting for the expanded HHVBP Model
with the CY 2022 performance year data, continuing for all performance
years thereafter.
We are proposing to amend Sec. 484.315 to reflect our proposal not
to publicly report performance data from the CY 2020 performance year
by removing paragraph (d). We seek comments on this proposal.
[[Page 35948]]
IV. Home Health Quality Reporting Program (HH QRP) and Other Home
Health Related Provisions
A. Vaccinations for Home Health Agency Health Care Personnel
Health Care Personnel (HCP) are at risk of carrying COVID-19
infection to patients, experiencing illness or death as a result of
COVID-19 themselves, and transmitting it to their families, friends,
and the general public. We believe Home Health Agencies should educate
and promote vaccination among their HCP as part of their efforts to
assess and reduce the risk of transmission of COVID-19. HCP vaccination
can potentially reduce illness that leads to work absence and limit
disruptions to care. Centers for Disease Control and Prevention.
Overview of Influenza Vaccination among Health Care Personnel (https://www.cdc.gov/flu/toolkit/long-term-care/why.htm). Data from influenza
vaccination demonstrates that provider uptake of the vaccine is
associated with that provider recommending vaccination to patients,
Measure Application Committee Coordinating Committee Meeting
Presentation (http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx). We believe HCP COVID-19 vaccination
among Home Health staff could similarly increase uptake among that
patient population.
B. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care and patients' access
to their health information. To further interoperability in post-acute
care settings, CMS and the Office of the National Coordinator for
Health Information Technology (ONC) participate in the Post-Acute Care
Interoperability Workgroup (PACIO) (https://pacioproject.org/) to
facilitate collaboration with industry stakeholders to develop Fast
Healthcare Interoperability Resources (FHIR) standards. These standards
could support the exchange and reuse of patient assessment data derived
from the minimum data set (MDS), inpatient rehabilitation facility
patient assessment instrument (IRF-PAI), long-term care hospital
continuity assessment record and evaluation (LCDS), outcome and
assessment information set (OASIS), and other sources, including the
Hospice Outcome and Patient Evaluation Assessment (HOPE) if implemented
in the Hospice Quality Reporting Program through future rulemaking. The
PACIO Project has focused on FHIR implementation guides for functional
status, cognitive status and new use cases on advance directives and
speech, and language pathology. We encourage PAC provider and health IT
vendor participation as these efforts advance.
The CMS Data Element Library (DEL) continues to be updated and
serves as the authoritative resource for PAC assessment data elements
and their associated mappings to health IT standards such as Logical
Observation Identifiers Names and Codes and Systematized Nomenclature
of Medicine. The DEL furthers CMS' goal of data standardization and
interoperability. These interoperable data elements can reduce provider
burden by allowing the use and exchange of healthcare data; supporting
provider exchange of electronic health information for care
coordination, person-centered care; and supporting real-time, data
driven, clinical 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 \36\ that will enable the nationwide exchange of electronic
health information across health information networks and provide an
important way to enable bi-directional health information exchange in
the future. For more information on current developments related to
TEFCA, we refer readers to https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement and
https://rce.sequoiaproject.org/.
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\36\ 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.\37\ For a healthcare
provider (as defined in 45 CFR 171.102), specifies that the provider
knows that the practice is unreasonable as well as likely to interfere
with, prevent, or materially discourage access (see 45 CFR 171.103,
exchange, or use of electronic health information. To deter information
blocking, health IT developers of certified health IT, health
information networks and health information exchanges whom the HHS
Inspector General determines, following an investigation, have
committed information blocking, are subject to civil monetary penalties
of up to $1 million per violation. Appropriate disincentives for health
care providers need to be established by the Secretary through
rulemaking. Stakeholders can learn more about information blocking at
https://www.healthit.gov/curesrule/final-rule-policy/information-blocking. ONC has posted information resources including fact sheets
(https://www.healthit.gov/curesrule/resources/fact-sheets), frequently
asked questions (https://www.healthit.gov/curesrule/resources/information-blocking-faqs), and recorded webinars (https://www.healthit.gov/curesrule/resources/webinars).
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\37\ 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
[[Page 35949]]
that the Secretary determines are appropriate for the measurement of
health care quality. To the extent that an HHA does not submit data in
accordance with this clause, the Secretary shall reduce the home health
market basket percentage increase applicable to the HHA for such year
by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) of the
Act, depending on the market basket percentage increase applicable for
a particular year, the reduction of that increase by 2 percentage
points for failure to comply with the requirements of the HH QRP and
further reduction of the increase by the productivity adjustment
(except in 2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of
the Act may result in the home health market basket percentage increase
being less than 0.0 percent for a year, and may result in payment rates
under the Home Health PPS for a year being less than payment rates for
the preceding year.
For more information on the policies we have adopted for the HH
QRP, we refer readers to the following rules:
CY 2007 HH PPS final rule (71 FR 65888 through 65891).
CY 2008 HH PPS final rule (72 FR 49861 through 49864).
CY 2009 HH PPS update notice (73 FR 65356).
CY 2010 HH PPS final rule (74 FR 58096 through 58098).
CY 2011 HH PPS final rule (75 FR 70400 through 70407).
CY 2012 HH PPS final rule (76 FR 68574).
CY 2013 HH PPS final rule (77 FR 67092).
CY 2014 HH PPS final rule (78 FR 72297).
CY 2015 HH PPS final rule (79 FR 66073 through 66074).
CY 2016 HH PPS final rule (80 FR 68690 through 68695).
CY 2017 HH PPS final rule (81 FR 76752).
CY 2018 HH PPS final rule (82 FR 51711 through 51712).
CY 2019 HH PPS final rule with comment period (83 FR
56547).
CY 2020 HH PPS final rule with comment period (84 FR
60554).
CY 2021 HH PPS final rule (85 FR 70326 through 70328).
2. General Considerations Used for the Selection of Quality Measures
for the HH QRP
For a detailed discussion of the considerations we historically use
for measure selection for the HH QRP quality, resource use, and others
measures, we refer readers to the CY 2016 HH PPS final rule (80 FR
68695 through 68696). In the CY 2019 HH PPS final rule with comment (83
FR 56548 through 56550) we also finalized the factors we consider for
removing previously adopted HH QRP measures.
3. Quality Measures Currently Adopted for the CY 2022 HH QRP
The HH QRP currently includes 20 measures for the CY 2022 program
year, as outlined in Table 28 of the CY 2020 . HH PPS final rule (84 FR
60555).38 39
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\38\ The HHCAHPS has five component questions that together are
used to represent one NQF-endorsed measure.
\39\ Data collection delayed due to the COVID-19 public health
emergency for the TOH-Patient and TOH-Provider.
\40\ Data collection delayed due to the COVID-19 public health
emergency for the TOH-Patient and TOH-Provider.
\41\ Ibid.
\42\ The HHCAHPS has five component questions that together are
used to represent one NQF-endorsed measure.
[GRAPHIC] [TIFF OMITTED] TP07JY21.052
[[Page 35950]]
4. Proposed Changes for the HH QRP
a. Proposal To Remove the Drug Education on All Medications Provided to
Patient/Caregiver Measure Beginning With the CY 2023 HH QRP
The CMS Meaningful Measures framework seeks to identify the highest
priorities for quality measurement and improvement and reduce where
possible the burden on providers and clinicians.\43\ In line with our
meaningful measures initiative, we are proposing to remove the Drug
Education on All Medications Provided to Patient/Caregiver During All
Episodes of Care measure from the HH QRP under measure removal factor
1: Measure performance among HHAs is so high and unvarying that
meaningful distinctions in improvements in performance can no longer be
made.
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\43\ 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.\44\
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\44\ 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.\45\
Further, the truncated coefficient of variation for this measure was
0.03, suggesting that it is not useful to draw distinctions between
individual agency performance scores for this measure.\46\
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\45\ Analysis of Home Health OASIS episodes from 2010 to 2019.
\46\ 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
(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.\48\ \49\ \50\ The Medicare Payment Advisory
Commission (MedPAC) and a study by Jencks et al. estimated that 17-20
percent of Medicare beneficiaries discharged from the hospital were
readmitted within 30 days. Among these hospital readmissions, MedPAC
has estimated that 76 percent were considered potentially avoidable and
associated with $12 billion in Medicare expenditures.\51\ \52\ An
analysis of data from a nationally representative sample of Medicare
FFS beneficiaries receiving HH services in 2004 show that HH patients
receive significant amounts of acute and post-acute services after
discharge from HH care.\53\ Focusing on readmissions, Madigan and
colleagues studied data on 74,580 Medicare HH patients and found that
the 30-day rehospitalization rate was 26 percent, with the largest
proportion related to a cardiac-related diagnosis (42 percent).\54\ A
study of data on dually eligible Medicare and Medicaid beneficiaries
hospitalizations from nursing home and home and community based
services waiver programs found that 39 percent of admissions were
potentially avoidable.\55\
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\48\ 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.
\49\ Moy, E., Chang, E., and Barret, M. Potentially Preventable
Hospitalizations--United States, 2001-2009. MMWR, 2013, 62(03);139-
143.
\50\ Jencks, S.F., M.V. Williams, and E.A. Coleman.
Rehospitalizations among Patients in the Medicare Fee-for-Service
Program. New England Journal of Medicine, 2009. 360(14): p. 1418-
1428.
\51\ Ibid.
\52\ MedPAC, Payment policy for inpatient readmissions, in
Report to the Congress: Promoting Greater Efficiency in Medicare.
2007: Washington DC p. 103-120.
\53\ 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.
\54\ 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.
\55\ 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.\56\ An additional beneficiary characteristic
that is associated with a potential for hospitalization is the time
since a beneficiary's most recent hospitalization \57\ and chronic
conditions such as chronic obstructive pulmonary disease and congestive
heart failure.\58\ How HHAs address these factors, including how HHAs
address chronic conditions present before the HH stay, can determine
whether beneficiaries can successfully avoid hospitalizations.\59\
Understanding these factors can help HHAs design strategies to address
avoidable hospitalizations.
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\56\ Lohman M.C., Cotton, B.P., Zagaria, A.B., Bao, Y.,
Greenberg, R.L., Fortuna, K.L., Bruce, M.L. Hospitalization Risk and
Potentially Inappropriate Medications among Medicare Home Health
Nursing Patients,(2017) J Gen Intern Med. 32(12):1301-1308.
\57\ Hua M., Gong, M.N., Brady J., Wunsch, H. Early and late
unplanned rehospitalizations for survivors of critical illness(2015)
Critical Care Medicine;43(2):430-438.
\58\ Dye C., Willoughby D., Aybar-Damali B., Grady C., Oran R.,
Knudson A. Improving Chronic Disease Self-Management by Older Home
Health Patients through Community Health Coaching (2018). Int J
Environ Res Public Health. 15(4): 660.
\59\ Lohman M.C., Cotton, B.P., Zagaria, A.B., Bao, Y.,
Greenberg, R.L., Fortuna, K.L., Bruce, M.L. Hospitalization Risk and
Potentially Inappropriate Medications among Medicare Home Health
Nursing Patients, (2017) J Gen Intern Med. 32(12):1301-1308.
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Observation stays are also increasing nationally and can have
costly financial impacts, especially for patients.\60\ \61\ Patients
admitted for an observation stay can often be treated in the same
medical units and have similar medical needs as a patient admitted for
inpatient care, but the service is billed as outpatient services and
does not count as a referent patient stay in the calculations of
readmissions.\62\ Limitation of observation stays should be a goal of
HHAs along with efforts to limit inpatient hospitalizations.
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\60\ Lind K.D., Noel-Miller C.M., Sangaralingham L.R., Shah
N.D., Hess E.P., Morin P., Fernanda Bellolio M. Increasing Trends in
the Use of Hospital Observation Services for Older Medicare
Advantage and Privately Insured Patients. Med Care Res Rev. 2019.
Apr;76(2):229-239.
\61\ 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.
\62\ Sabbatini A.K., Wright B. Excluding Observation Stays from
Readmission Rates--What Quality Measures Are Missing, New England
Journal of Medicine, 31;378(22):2062-2065.
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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), CMS adopted the Emergency Department Use Without
Hospitalization During the First 60 Days of Home Health claims-based
measure to replace the OASIS-based Emergency Department Use Without
Hospitalization measure since the claims data offered a more robust
source of data for the measure. The M2300 item
[[Page 35952]]
used to calculate OASIS-based ED Use QM was deemed to be insufficiently
reliable in capturing emergency department visits. In the CY 2013 HH
PPS Final Rule (77 FR 67902), CMS adopted the Acute Care
Hospitalization During the First 60 Days of Home Health claims-based
measure to replace the OASIS-based Acute Care Hospitalization measure
since it made the determination that claims data provided a more robust
data source for accurately measuring acute care hospitalizations.
The Acute Care Hospitalization During the First 60 Days of Home
Health measure (NQF #0171) and Emergency Department Use Without
Hospitalization During the First 60 days of Home Health (NQF #0173)
measure are claims-based and were an improvement on addressing issues
related to emergency department use and acute hospitalization but they
also had limitations related to issues of attribution. In prior
feedback from an NQF technical review panel on the Emergency Department
Use Without Hospitalization During the First 60 days of Home Health
(NQF #1073), concerns were raised regarding the HHAs' ability to
prevent an emergency department visit, especially for visits that do
not result in a hospitalization. While some evidence suggests that care
coordination and HHA engagement can impact emergency department use by
patients, experts raised concerns that there were several drivers of
emergency department use outside the control of an HHA that could
result in an emergency department visit.\63\
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\63\ 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.\64\
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\64\ 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,\65\ approaches
developed by MedPAC, and proprietary approaches, such as the 3MTM
algorithm for potentially preventable hospitalizations.\66\ \67\ \68\
The existing literature addresses both hospital readmissions more
broadly and potentially avoidable hospitalizations for specific
settings like long-term care and highlights issues relevant to the
development of potentially preventable hospitalization measures for a
post-acute care setting such as home health.\69\ \70\
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\65\ Prevention Quality Indicators Overview. Available at:
https://www.qualityindicators.ahrq.gov/modules/pqi_resources.aspx.
\66\ Goldfield, N.I., McCullough, E.C., Hughes, J.S., et al.
Identifying potentially preventable readmissions. Health Care Finan.
Rev. 30(1):75-91, 2008. Available from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4195042/.
\67\ National Quality Forum: Prevention Quality Indicators
Overview. 2008.
\68\ 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.
\69\ Gao, J., Moran, E., Li, Y.-F., et al. Predicting
potentially avoidable hospitalizations. Med. Care 52(2):164-171,
2014. doi:10.1097/MLR.0000000000000041.
\70\ 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[hyphen]and
community[hyphen]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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(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 Diagnosis Group Model
on the specifications of this measure. CMS has undertaken a review of
the implications on the new payment model on this and other claims-
based QMs in the HH QRP and determined that the claims-based QMs are
not adversely affected by the new model.
(3) Measure Application Partnership (MAP) Review
Our pre-rulemaking process includes making publicly available a
list of quality and efficiency measures, called the Measures under
Consideration (MUC) List that the Secretary is considering adopting
through the Federal rulemaking process for use in Medicare programs.
This allows 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.\71\
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\71\ 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
[[Page 35953]]
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.\72\
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\72\ 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.
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We also performed analyses on Medicare claims data to identify the
most frequent diagnoses associated with admissions among home health
beneficiaries, and then applied the conceptual potentially preventable
hospitalization definition to evaluate whether these common conditions
for a hospitalization may be considered potentially preventable. This
list of conditions identified from literature and claims analysis
formed the preliminary potentially preventable hospitalization
definition. We grouped these conditions based on clinical rationale,
and the major groups are: (1) Inadequate management of chronic
conditions; (2) Inadequate management of infections; (3) Inadequate
management of other unplanned events; and (4) Inadequate injury
prevention.
Additional details regarding the definition for potentially
preventable hospitalizations are available in the document titled
``Proposed PPH Measure Specification for the CY 2022 HH QRP NPRM''
available at https://www.cms.gov/Medicare/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 \73\ and Potentially
Preventable Within Stay Readmission Measure for Inpatient
Rehabilitation Facilities \74\ measures.
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\73\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.html.
\74\ 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:
[[Page 35954]]
Demographic characteristics (age, sex, original reason for
Medicare entitlement).
Care received during prior proximal hospitalization \75\
(if applicable) (including the length of the hospitalization and
principal diagnoses during the prior proximal hospitalization).
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\75\ Prior proximal hospitalizations for this measure are
defined as inpatient stays within 30 days prior to home health
admission.
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Other care received within a year of stay (including
number of prior acute discharges, number of outpatient emergency
department visits, number of skilled nursing visits, number of
inpatient rehabilitation facility visits, number of long term care
hospital visits, and comorbidities from a prior proximal
hospitalization [if applicable] or other visits in the last year).
The proposed measure is calculated using a calendar year of
Medicare FFS data. In addition, we propose a minimum of 20 eligible HH
stays as defined in the introduction to this proposal for public
reporting of the proposed measure. All HH stays during the year time
window, except those that meet the exclusion criteria, would be
included in the measure. The PPH observation window begins from the
start of HH stay and spans to 1 day after discharge. Data from all HH
stays beginning from 1/1/2016-12/31/2016 was used for the PPH measure
development. For technical information about this proposed measure
including information about the measure calculation, risk adjustment,
and exclusions, we refer readers to our Proposed PPH Measure
Specification for the CY 2022 HH QRP NPRM at https://www.cms.gov/Medicare/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,\76\ we are proposing to remove the Acute Care
Hospitalization During the First 60 Days of Home Health (NQF #0171)
measure and the Emergency Department Use Without Hospitalization During
the First 60 days of Home Health (NQF #0173) measure and replace them
with the PPH measure. We are proposing to remove these two measures
from the HH QRP beginning with the CY 2023 HH QRP under our measure
removal Factor 6: A measure that is more strongly associated with
desired patient outcomes for the particular topic is available.
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\76\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.
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The Acute Care Hospitalization During the First 60 Days of Home
Health (NQF #0171) and Emergency Department Use Without Hospitalization
During the First 60 days of Home Health (NQF #0173) measures are both
claims-based and have some notable limitations related to appropriate
attribution of the acute hospitalization or emergency department visit
to an HHA. These measures focus on hospitalization regardless of
whether a HHA could provide care that could prevent the visit whereas
the proposed PPH measure addresses the limitations of these measures by
focusing on inpatient admissions and observation stays that research
establishes could be prevented by HHA care provided to patients they
serve.
We propose to remove the Acute Care Hospitalization during the
First 60 Days of Home Health (NQF #0171) measure and Emergency
Department Use Without Hospitalization During the First 60 days of Home
Health (NQF #0173) measure and replace them with the Home Health
Within-Stay Potentially Preventable Hospitalization claims-based
measures beginning with the CY 2023 HH QRP.
We invite public comments on this proposal.
c. Proposed Schedule for Publicly Reporting Quality Measures Beginning
With the CY 2022 HH QRP
Section 1899B(g)(1) of the Act requires, in part, that the
Secretary provide for public reporting of PAC provider performance,
including HHAs, on quality measures under section 1899B(c)(1) of the
Act, including by establishing procedures for making available to the
public information regarding the performance of individual PAC
providers with respect to such measures. Section 1899B(g)(2) of the Act
requires, in part, that CMS give HHAs opportunity to review and submit
corrections to the data and information to be made public under section
1899B(g)(1) of the Act prior to such data being made public. Section
1899B(g)(3) of the Act requires that such procedures provide that the
data and information with respect to a measure and PAC provider is made
publicly available beginning not later than 2 years after the
applicable specified application date applicable to such measure and
provider.
In the CY 2018 HH PPS final rule, we adopted the Percent of
Residents Experiencing One or More Falls with Major Injury measure
beginning with the CY 2020 HH QRP under section 1899B(c)(1)(D) of the
Act (82 FR 51727 through 51730). Under section
1899B(a)(2)(E)(i)(IV)(bb) of the Act, the specified application date
for HH QRP measures adopted under section 1899B(c)(1)(D) of the Act is
January 1, 2019; two years after this date is January 1, 2021.
We also adopted in the CY 2018 HH PPS final rule the Application of
Percent of Long-Term Care Hospital Patients with an Admission and
Discharge Functional Assessment measure beginning with the CY 2020 HH
QRP (82 FR 51722 through 51727) under section 1899B(c)(1)(A) of the
Act. Under section 1899B(a)(2)(E)(i)(I)(cc) of the Act, the specified
application date for HH QRP measures adopted under section
1899B(c)(1)(A) of the Act is January 1, 2019; two years after this date
is January 1, 2021.
We propose to publicly report the Percent of Residents Experiencing
One or More Major Falls with Injury measure and Application of Percent
of 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 on the HH confidential
feedback reports. The Percent of Residents Experiencing One or More
Major Falls with Injury measure was added to the HHA Review and Correct
Report effective 04/01/2019, and the HHA Outcome Measures Report
effective 01/01/2020. The measure Application of Percent of Long-Term
Care Hospital Patients with an Admission and Discharge Functional
Assessment and a Care Plan that Addresses Function (NQF #2631) was
added to the HHA Review and Correct Report effective 04/01/2019, and
the HHA Process Measures Report effective 01/01/2020. HHAs' HH QRP
measure scores for these two measures would additionally be made
available for review on the HH Provider Preview Report, which would be
issued in January 2022, three months in advance of the inaugural
display of these measures on Care Compare.
We invite public comments on our proposed schedule to publicly
display these measures.
[[Page 35955]]
d. Proposed Revised Compliance Date for Certain HH QRP Reporting
Requirements
(1) Background
In the May 8, 2020 Federal Register (85 FR 27550), we published an
interim final rule with comment period titled ``Medicare and Medicaid
Programs, Basic Health Program, and Exchanges; Additional Policy and
Regulatory Revisions in Response to the COVID-19 Public Health
Emergency and Delay of Certain Reporting Requirements for the Skilled
Nursing Facility Quality Reporting Program'' (which we will refer to as
``IFC-2''). In IFC-2, we delayed the compliance date for certain
reporting requirements under the HH QRP (85 FR 27595 through 27596).
Specifically, we delayed the requirement for HHAs to begin reporting
the Transfer of Health (TOH) Information to PAC and the TOH Information
to Patient-PAC measures and the requirement for HHAs to begin reporting
certain Standardized Patient Assessment Data Elements to January 1st of
the year that is at least one full calendar year after the end of the
COVID-19 Public Health Emergency (PHE). CMS also delayed the adoption
of the updated version of the Outcome and Assessment Information Set
(OASIS) assessment instrument (OASIS-E) for which HHAs would report the
Transfer of Health (TOH) measures and certain Standardized Patient
Assessment Data Elements.
Under IFC-2, HHAs must use OASIS-E to begin collecting data on the
two TOH Information measures beginning with discharges and transfers on
January 1st of the year that is at least one full calendar year after
the end of the COVID-19 PHE. HHAs must also begin collecting data on
certain Standardized Patient Assessment Data Elements on the OASIS-E,
beginning with the start of care, resumption of care, and discharges
(except for the hearing, vision, race, and ethnicity Standardized
Patient Assessment Data Elements, which would be collected at the start
of care only) on January 1st of the year that is at least one full
calendar year after the end of the COVID-19 PHE. The delay to begin
collecting data for these measures was to provide relief to HHAs from
the added burden of implementing an updated instrument during the
COVID-19 PHE. We wanted to provide maximum flexibilities for HHAs to
respond to the public health threats posed by the COVID-19 PHE, and to
reduce the burden in administrative efforts associated with attending
trainings, training their staff, and working with their vendors to
incorporate the updated assessment instruments into their operations.
At the time we finalized the policy in the IFC-2, we believed that
the delay in collection of the TOH Information measures and
Standardized Patient Assessment Data Elements would not have a
significant impact on the HH QRP. However, the COVID-19 PHE showed the
important need for these TOH Information measures and Standardized
Patient Assessment Data Elements under the HH QRP. The PHE's
disproportionate impact on minority populations demonstrates the
importance of analyzing this impact and the needs for these populations
to improve quality of care within HHAs, especially during a public
health emergency.
(2) Current Assessment of HHAs
To accommodate the COVID-19 PHE, CMS has provided additional
guidance and as a result HHAs have adopted new processes as well as
modified existing processes. For example, HHAs currently have the
option to complete what was required to be a face-to-face encounter to
qualify for home health via telehealth and the completion of aspects of
required comprehensive assessments via telehealth.\77\ CMS also
supported PAC providers, including HHAs, by providing requested
flexibilities in the delivery of care in response to the PHE. In
addition, we assisted providers by conducting sessions for HHAs to
share best practices that agencies have identified to address many of
the challenges posed by the PHE.
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\77\ 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.\78\ Since IFC-2 was finalized, the industry
has identified a growing demand for home health services and has noted
their ability to meet this demand.\79\ \80\ \81\ \82\
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\78\ https://www.healthaffairs.org/do/10.1377/hblog20201214.543463/full/.
\79\ https://www.hartfordbusiness.com/article/demand-for-home-health-care-surges-amid-covid-19-shifting-industry-landscape.
\80\ 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.
\81\ https://www.wsj.com/articles/demand-for-in-home-care-rises-during-coronavirus-11588003076.
\82\ 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. Proposal To Collect the Transfer of Health Information to Provider-
PAC Measure, the Transfer of Health Information to Patient-PAC Measure,
and Certain Standardized Patient Assessment Data Elements Beginning
January 1, 2023
We are proposing to revise the compliance date from IFC-2 to
January 1, 2023. This revised date would begin the collection of data
on the Transfer of Health Information to Provider-PAC measure and
Transfer of Health Information to Patient-PAC measure, and certain
Standardized Patient Assessment Data Elements on the updated version of
the OASIS assessment instrument referred to as OASIS-E. This revised
date of January 1, 2023, which is a two-year delay from this original
compliance date finalized in the CY 2020 HH PPS final rule (84 FR 60557
through 60610), balances the support that HHAs needed during much of
the COVID-19 PHE as CMS provided flexibilities to support HHAs along
with the need to collect this important data.
The need for the Standardized Patient Assessment Data Elements and
Transfer of Health data have shown to be even more pressing with issues
of inequities that the COVID-19 PHE laid bare. This
[[Page 35956]]
data that includes addressing SDOH provides information that is
expected to improve quality of care for all. Consequently, we are
proposing to revise the compliance date to reflect this balance and
assure that this data collection begins on January 1, 2023.
As stated in the CY 2020 HH PPS final rule, CMS will provide the
training and education for HHAs to be prepared for this implementation
(84 FR 60554). In addition, if CMS adopts a January 1, 2023 compliance
date, CMS would release a draft of the updated version of the OASIS
instrument, OASIS-E, in early 2022.
Based upon our evaluation, we propose that HHAs would collect the
Transfer of Health Information to Provider Post-Acute Care measure, the
Transfer of Health Information to Patient-PAC measure, and certain
Standardized Patient Assessment Data Elements beginning January 1,
2023. We propose that, accordingly, HHAs would begin collecting data on
the two TOH measures beginning with discharges and transfers on January
1, 2023 on the OASIS-E. We also propose that HHAs would begin
collecting data on the six categories of Standardized Patient
Assessment Data Elements on the OASIS-E, with the start of care,
resumption of care, and discharges (except for the hearing, vision,
race, and ethnicity Standardized Patient Assessment Data Elements,
which would be collected at the start of care only) beginning on
January 1, 2023.
We invite public comment on these proposals.
D. Proposed Changes to the Home Health Conditions of Participation
1. Background and Statutory Authority
Since March, 2020, CMS has issued a number of regulatory waivers in
response to the COVID-19 PHE under our statutory authority granted by
section 1135 of the Act. That statute permits the Secretary to waive
certain statutes and regulations during a public health emergency
declared by the President, in order to expand healthcare system
capacity while continuing to maintain public and patient safety, and to
hold harmless providers and suppliers who may be unable to comply with
existing regulations after a good faith effort. Specifically, the
Secretary may temporarily waive or modify certain Medicare, Medicaid,
and Children's Health Insurance Program (CHIP) requirements to ensure:
Sufficient health care items and services are available to meet the
needs of individuals enrolled in Medicare, Medicaid and CHIP in the
emergency area during the emergency period. In such circumstances,
providers can be reimbursed and exempted from sanctions under these
programs (absent any determination of fraud or abuse).
We issued a variety of regulatory waivers that pertained to most
CMS-certified providers and suppliers during the COVID-19 PHE,
including HHAs. Sections 1861(o) and 1891 of the Act authorize the
Secretary to establish the requirements that an HHA must meet to
participate in the Medicare Program, and these conditions of
participation (CoPs) are set forth in regulations at 42 CFR part 484.
We waived selected requirements for HHAs within part 484 for the
duration of the PHE. While some of these waivers simply delay certain
administrative deadlines, others directly impact the provision of
patient care. We have identified waivers related to the requirements
for the supervision of home health aides at Sec. 484.80(h)(1) and (2)
that we believe would be appropriate as permanent policy. These
proposed changes and their respective background information are
discussed in detail.
In addition, in order to implement section 115 of Division CC of
the CAA 2021, we are proposing to modify the requirements for the home
health initial assessment visit and comprehensive assessment. This
statutorily-required modification allows an occupational therapist to
complete the initial and comprehensive assessments for Medicare
patients when occupational therapy is ordered with another
rehabilitation therapy service (speech language pathology or physical
therapy) that establishes program eligibility. This would only be
permitted if skilled nursing services have not been ordered.
2. Provisions of the Proposed Regulations
We propose the following revisions to the HHA CoPs.
a. Home Health Aide Supervision
Home health aides deliver a significant portion of direct home
health care. Ensuring that aide services are meeting the patient's
needs is a critical part in maintaining safe, quality care. At 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 484.80(g). However, we believe it is important to permit HHA's to
complete this assessment virtually, in the rare circumstance that an
onsite visit cannot be coordinated within the 14-day time period.
We propose that HHAs be permitted to use interactive
telecommunications systems for purposes of aide supervision, on
occasion, not to exceed 2 virtual supervisory assessments per HHA in a
60-day period. We are proposing to revise the language at 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 are proposing the define
interactive telecommunications systems as multimedia communications
equipment that includes, at a minimum, audio and video equipment
permitting two-way, real-time interactive communication between the
patient and distant site physician or practitioner. The use of
interactive telecommunications systems for the aide supervisory
assessment must not exceed 2 virtual supervisory
[[Page 35957]]
assessments per HHA in a 60-day period, regardless of the number of
aides or patients associated with a given HHA. If the supervising
individual notes an area of concern during the 14-day supervisory
assessment, the supervising individual must make an on-site in-person
visit to the location where the patient is receiving care while the
aide is performing care, in order to observe and assess the aide as
required at Sec. 484.80(h)(1)(ii) and (iii).
While we are proposing to allow this flexibility, we expect that in
most instances, the HHAs would plan to conduct the 14-day supervisory
assessment during an on-site, in person visit, and that the HHA would
use interactive telecommunications systems option only for unplanned
occurrences that would otherwise interrupt scheduled in-person visits.
Examples of circumstances in which a scheduled on-site in-person visit
may not be able to be rescheduled timely within the 14-day window could
include a severe weather occurrence, a patient requests to change the
date of the scheduled visit, or unexpected staff illness or absence on
the planned day for the visit.
We are not proposing changes to the requirements for annual aide
assessments at 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 are also proposing 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 propose to maintain the first part of this requirement, that the
registered nurse must make a visit in person every 60 days, but would
remove the requirement that the RN must directly observe the aide in
person during those visits. We would accomplish this by removing the
language from 42 CFR 484.80(h)(2) that states, ``in order to observe
and assess each home health aide while he or she is performing care,''
and replacing it with ``to assess the quality of care and services
provided by the home health aide and to ensure that services meet the
patient's needs''. In addition, we propose to further revise the
requirement to state that the home health aide would not need to be
present during this visit. We believe that these proposed revisions
from an on-site (direct) observation of each aid while performing care
to an indirect supervision visit to assess the adequacy of the aide
care plan, the patient's perception of services provided, and hear any
concerns from the patient; may better support the patients' needs by
allowing for open communication between the nurse and patient. If a
deficiency in the aide services are assessed, the agency must conduct
and the home health aide must complete, retraining and a competency
evaluation for the deficient and all related skills.
In order to ensure appropriate RN supervision of HHA aides caring
for patients who are not receiving skilled services, we propose to add
a new requirement to 42 CFR 484.80(h)(2) that would require the RN to
make a 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 propose to maintain this requirement at 484.80(h)(3), but to
modify it by adding ``and all related skills.'' We believe that when a
deficient area(s) in the aide's care are assessed and verified by the
RN, additional related competencies may reflect deficient practice
areas that should be addressed. For example, if the patient informs the
nurse that they almost fell when the aide was transferring them from
bed to a chair, the nurse should assess the aide's technique for
transferring a patient in other circumstances beyond transfer to a
chair, such as transferring from a bed to bedside commode or to a
shower chair.
We request public comment on our proposed changes to allow virtual
supervisory assessments of home health aides for patients receiving
skilled care at 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
welcome comments from patients and caregivers who have experienced
virtual supervisory assessments of home health aides during the PHE.
b. Permitting Occupational Therapists To Conduct the Initial Assessment
Visit and Complete the Comprehensive Assessment for Home Health
Agencies Under the Medicare Program
On December 27, 2020, the CAA, 2021 was signed into law. Division
CC, section 115 of the CAA 2021 requires CMS to permit an occupational
therapist to conduct the initial assessment visit and complete the
comprehensive assessment under the Medicare program, but only when
occupational therapy is on the home health plan of care with either
physical therapy or speech therapy and skilled nursing services are not
initially on the plan of care. We are proposing to conforming
regulation text changes at Sec. 484.55(a)(2) and (b)(3), respectively
to implement this provision.
Currently, the requirement at Sec. 484.55(a)(2) states, ``When
rehabilitation therapy service (speech language pathology, physical
therapy, or occupational therapy) is the only service ordered by the
physician or allowed practitioner who is responsible for the home
health plan of care, and if the need for that service establishes
program eligibility, the initial assessment visit may be made by the
appropriate rehabilitation skilled
[[Page 35958]]
professional.'' We are proposing to add additional language that allows
the occupational therapist to complete the initial assessment for
Medicare patients when skilled nursing is not initially on the plan of
care, but occupational therapy is ordered with another rehabilitation
therapy service (speech language pathology or physical therapy) that
establishes program eligibility as a need for occupational therapy
alone would not initially establish program eligibility under the
Medicare home health benefit (see section 1814(a)(2)(c) and
1835(a)(2)(A) of the Act). Similarly, at Sec. 484.55(b)(3), we are
proposing to modify our regulatory language to allow an occupational
therapist to complete the comprehensive assessment for Medicare
patients when ordered with another qualifying rehabilitation therapy
service (speech language pathology or physical therapy) that
establishes program eligibility and when skilled nursing is not
initially part of the plan of care. It should be noted that the
statutory requirements for establishing Medicare program eligibility
have not changed. Therefore, only the need for skilled nursing,
physical therapy or speech language pathology services can initially
establish eligibility for Medicare home health care. However,
occupational therapy can maintain eligibility for Medicare home health
care after the need for skilled nursing, physical therapy, and speech
language pathology services have ceased (see sections 1814(a)(2)(C) and
1835(a)(2)(A) of the Act).
c. Adequacy of Aide Staffing
As stated earlier, ensuring that aide services are meeting the
patient's needs is a critical part in maintaining safe, quality care.
However, in 2019 MedPAC reported that between 1998 and 2017 home health
visits declined by 88 percent. CMS seeks information about the adequacy
of aide staffing and requests comments on the following:
Whether home health agencies employ or arrange for (under
contract) home health aides to provide aide services;
The number of home health aides per home health agency
(both directly employed and under contract), and whether the number has
increased or decreased over the past 5-10 years;
The average number of aide hours per beneficiary with aide
service ordered on the plan of care;
The effect of the public health emergency on the ability
of HHAs to employ home health aides or arrange for (under contract) the
provision of home health aide services.
V. Home Infusion Therapy Services: Annual Payment Updates for CY 2022
A. Home Infusion Therapy Payment Categories
Section 5012 of the 21st Century Cures Act (``the Cures Act'')
(Pub. L. 114-255), which amended sections 1834(u), 1861(s)(2) and
1861(iii) of the Act, established a new Medicare home infusion therapy
services benefit, effective January 1, 2021. The Medicare home infusion
therapy services benefit covers the professional services, including
nursing services, furnished in accordance with the plan of care,
patient training and education not otherwise covered under the durable
medical equipment benefit, remote monitoring, and monitoring services
for the provision of home infusion therapy furnished by a qualified
home infusion therapy supplier.
Section 50401 of the Bipartisan Budget Act (BBA) of 2018 amended
section 1834(u) of the Act by adding a new paragraph (7) that
established a home infusion therapy services temporary transitional
payment for eligible home infusion suppliers for certain items and
services furnished in coordination with the furnishing of transitional
home infusion drugs beginning January 1, 2019. The temporary
transitional payment began on January 1, 2019 and ended the day before
the full implementation of the home infusion therapy services benefit
on January 1, 2021.
For the full implementation of the home infusion therapy services
benefit on January 1, 2021, CMS established a unit of single payment
for each infusion drug administration calendar day in the individual's
home. In accordance with section 1834(u)(1)(A)(ii) of the Act, a unit
of single payment must be established for different types of infusion
therapy, taking into account variation in utilization of nursing
services by therapy type. Furthermore, section 1834(u)(1)(B)(ii) of the
Act required that the single payment amount reflect factors such as
patient acuity and complexity of drug administration. In the CY 2020 HH
PPS final rule with comment period (84 FR 60628), we finalized our
proposal to maintain the three payment categories that were utilized
under the temporary transitional payments for home infusion therapy
services. The three payment categories group home infusion drugs by J-
code based on therapy type. The single payment amount for each payment
category varies by utilization of nursing services and reflects patient
acuity and complexity of drug administration, and; therefore,
ultimately reflects variations in infusion drug administration
services. Payment category 1 comprises certain intravenous infusion
drugs for therapy, prophylaxis, or diagnosis, including antifungals and
antivirals; inotropic and pulmonary hypertension drugs; pain management
drugs; and chelation drugs. Payment category 2 comprises subcutaneous
infusions for therapy or prophylaxis, including certain subcutaneous
immunotherapy infusions. Payment category 3 comprises intravenous
chemotherapy infusions and other highly complex intravenous infusions.
We are not proposing to make any changes to the three payment
categories in CY 2022.
The categories and associated J-codes can be found in the MLN
Matters article entitled ``Billing for Home Infusion Therapy Services
On or After January 1, 2021'' (MM11880).\83\ This list will be updated
as new drugs and biologicals are added to the DME LCD and determined to
be ``home infusion drugs.'' The list of home infusion drugs and their
respective payment categories do not need to be updated through
rulemaking when a new drug is added to the DME LCD for External
Infusion Pumps (L33794).\84\\.\ The payment category may be determined
by the DME MAC for any subsequent home infusion drug additions to the
DME LCD for External Infusion Pumps (L33794) \85\ as identified by the
following NOC codes: J7799 (Not otherwise classified drugs, other than
inhalation drugs, administered through DME) and J7999 (Compounded drug,
not otherwise classified). Payment category 1 would include any
appropriate subsequent intravenous infusion drug additions, payment
category 2 would include any appropriate subsequent subcutaneous
infusion drug additions, and payment category 3 would include any
appropriate subsequent intravenous chemotherapy or other highly complex
drug or biologic infusion additions.
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\83\ Billing for Home Infusion Therapy Services On or After
January 1, 2021 (MM11880). https://www.cms.gov/files/document/mm11880.pdf.
\84\ Local Coverage Determination (LCD): External Infusion Pumps
(L33794). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33794.
\85\ 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
[[Page 35959]]
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 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.
It is important to note that the list of home infusion drugs is
maintained by the DME MACs, and the drugs or their respective payment
categories for purposes of the home infusion therapy services benefit
do not need to be updated through rulemaking every time a new drug is
added to the DME LCD for External Infusion Pumps (L33794). For these
routine updates, CMS will implement such changes through the
subregulatory change request process.
B. Payment Adjustments for CY 2022 Home Infusion Therapy Services
1. Home Infusion Therapy Geographic Wage Index Adjustment
Section 1834(u)(1)(B)(i) of the Act requires that the single
payment amount be adjusted to reflect a geographic wage index and other
costs that may vary by region. In the CY 2020 HH PPS final rule with
comment period (84 FR 60629) we finalized the use of the geographic
adjustment factor (GAF) to adjust home infusion therapy payments for
differences in geographic area wages rates based on the location of the
beneficiary. We remind stakeholders that the GAFs are a weighted
composite of each Physician Fee Schedule (PFS) localities work,
practice expense (PE) and malpractice (MP) expense geographic practice
cost indices (GPCIs) using the national GPCI cost share weights. The
periodic review and adjustment of GPCIs is mandated by section
1848(e)(1)(C) of the Act. At each update, the proposed GPCIs are
published in the PFS proposed rule to provide an opportunity for public
comment and further revisions in response to comments prior to
implementation. The GPCIs and the GAFs are updated triennially with a
2-year phase in and were last updated in the CY 2020 PFS final rule.
The next full update to the GPCIs and the GAFs will be in the CY 2023
PFS proposed rule. For CY 2022, there will be changes to the GAF values
for the majority of localities located in California because CY 2022 is
the last year of a 5-year incremental transition for the majority of
the California localities implemented in 2017 in accordance with the
Protecting Access to Medicare Act of 2014 (PAMA 2014). The CY 2022 PFS
proposed GAFs will be available on the PFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched.
In the CY 2020 HH PPS final rule with comment period (84 FR 60629)
we stated that the application of the GAF would be budget neutral so
there is no overall cost impact by applying a budget-neutrality factor.
We propose to continue this practice and apply the GAF budget-
neutrality factor to the home infusion therapy service payment rates
whenever there are changes to the GAFs in order to eliminate the
aggregate effect of variations in the GAFs. For CY 2022, the GAF
standardization factor would equal the ratio of the estimated national
spending total using the CY 2021 GAF to the estimated national spending
total using the CY 2022 GAF. Estimates of national spending totals
would use home infusion therapy benefit utilization data for CY 2020.
The CY 2022 GAF was not available in time for this proposed rule. We
will calculate the CY 2022 GAF standardization factor that will be used
in updating the payment amounts for CY 2022 and we will include this
information in a forthcoming change request that would be issued to
implement the CY 2022 home infusion therapy services payment amounts.
The CY 2022 GAF values will be posted as an addendum on the PFS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-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 web page.\86\
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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 CPI-U for the 12-
month period ending with June of the preceding year, reduced by a
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
the Act as the 10-year moving average of changes in annual economy-wide
private nonfarm business multifactor productivity. Section 1834(u)(3)
of the Act further states that the application of the productivity
adjustment may result in a percentage being less than 0.0 for a year,
and may result in payment being less than such payment rates for the
preceding year.
The CPI-U for the 12-month period ending with June of the preceding
year is not available at the time of this proposed rulemaking. The CPI-
U for the 12-month period ending in June of 2021 and the corresponding
productivity adjustment will be updated in the final rule.
3. Initial and Subsequent Visit Adjustment
In the CY 2020 HH PPS final rule with comment period (84 FR 60627),
we finalized our policy that the payment amounts for each of the three
payment categories for the first home infusion therapy visit by the
qualified home infusion therapy supplier in the patient's home will be
increased by the average difference between the PFS
[[Page 35960]]
amounts for E/M existing patient visits and new patient visits for a
given year, resulting in a small decrease to the payment amounts for
the second and subsequent visits, using a budget neutrality factor. We
remind stakeholders that effective January 1, 2021 there were changes
to the office/outpatient E/M visit code set (CPT codes 99201 through
99215) used to calculate the initial and subsequent visit payment
amounts for home infusion therapy. These changes were adopted from the
new coding, prefatory language, and interpretive guidance framework
that has been issued by the AMA's CPT Editorial Panel (see https://www.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 2021 HH PPS final rule (85 FR
70340), we estimated a 19 percent increase in the first visit payment
amount and a 1.18 percent decrease in subsequent visit amounts based on
the average difference between the CY 2021 proposed PFS E/M codes
amounts for new and existing patients. The percent increase remained 19
percent for the first visit payment amount and the percent decrease
remained 1.18 percent for subsequent visit amounts using the final PFS
E/M rates for new and existing patients.
However, Division N, section 101 of CAA 2021 added section
1848(t)(1) of the Act, which applied a 3.75 percent increase in PFS
payment amounts only for CY 2021.\87\ Division CC, section 113 of CAA
2021 also delayed the implementation of an add-on E/M code G2211 until
CY 2024. Because the PFS relative value units (RVUs) are budget
neutral, this delay in the implementation of the add-on code changed
the RVUs for all codes under the PFS, including the E/M codes used to
calculate the home infusion therapy service payment initial visit
percent increase. The updated RVUs and conversion factor after the
changes implemented by the CAA 2021 were used to recalculate the CY
2021 payment amounts for home infusion therapy services, and the
percent difference used to calculate the initial visit percentage
increase. As a result, the initial home infusion therapy service visits
increase was updated to 20 percent and the decrease for subsequent
visits was updated to 1.3310. We note that the change in the percent
increase for initial visits was driven by the delay of the code G2211.
While the updated payment amounts (after the changes implemented by the
CAA 2021) for the office/outpatient E/M codes were used to recalculate
the initial visit increase, removing the 3.75 percent does not impact
the average difference between the office/outpatient E/M codes for new
patient visits and existing patient because the increase was applied
equally. Therefore, after removing the adjustment, the percent increase
remains 20 percent for the initial visit payment amounts and a 1.3310
percent decrease for all subsequent visit payment amounts.
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In the CY 2021 final rule (85 FR 70298, 70339) we also stated that
we would increase the payment amounts for each of the three payment
categories for the first home infusion therapy visit by the qualified
home infusion therapy supplier in the patient's home by the average
difference between the PFS amounts for E/M existing patient visits and
new patient visits for a given year. Section 1834 (u)(3) of the Act
requires the rates from the previous year to be updated by the
percentage increase in the CPI-U for the 12-month period ending in June
of 2021 reduced by a productivity adjustment beginning in 2022.
Therefore, CMS is to update the established payment rates for CY 2021
by the percentage increase in the CPI-U reduced by the productivity
adjustment without recalculating the percent difference each year using
the updated values for the PFS E/M codes for CY 2022 payment purposes.
For CY 2022, we are proposing to maintain the 20 percent increase
calculated for the initial home infusion therapy service visits and the
1.3310 percent decrease calculated for subsequent visits after
implementation of the changes mandated by the CAA 2021, which we
previously noted did not impact these percentages. Table 34 shows the
updated E/M visit codes and the final unadjusted PFS payment amounts
(without the 3.75 percent increase implemented by the CAA 2021) for CY
2021, for both new and existing patients, used to determine the
increased payment amount for the first visit. We invite comments on our
proposal to maintain the percentages calculated for initial and
subsequent home infusion therapy service visits calculated after
implementing the changes mandated by the CAA 2021.
[[Page 35961]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.053
C. CY 2022 Payment Amounts for Home Infusion Therapy Services
As noted previously, Division N, section 101 of CAA 2021 amended
added section 1848(t)(1) of the Act, which applied and modified the CY
2021 PFS rates by providing a 3.75 percent increase in PFS payment
amounts only for CY 2021.\88\ For CY 2022, CMS will remove the 3.75
percent increase from the PFS amounts used to establish the CY 2021
home infusion therapy payment rates and use the unadjusted CY 2021
rates for these CY 2022 payment amounts will be updated for CY 2022 in
accordance with section 1834(u)(3) of the Act using the percentage
increase in the CPI-U for the 12-month period ending in June of 2021
reduced by the productivity adjustment, adjusted for MFP.
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The final home infusion therapy 5-hour payment amounts will be
released in a forthcoming change request CR and posted on the Home
Infusion Therapy Billing and Rates web page.\89\ For more in-depth
information regarding the finalized policies associated with the scope
of the home infusion therapy services benefit and conditions for
payment, we refer readers to the CY 2020 HH PPS final rule with comment
period (84 FR 60544).
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VI. Medicare Provider and Supplier Enrollment Changes
A. Background--Provider and Supplier Enrollment Process
1. General Discussion
Section 1866(j)(1)(A) of the Act requires the Secretary to
establish a process for the enrollment of providers and suppliers in
the Medicare program. The overarching purpose of the enrollment process
is to help confirm that providers and suppliers seeking to bill
Medicare for services and items furnished to Medicare beneficiaries
meet Federal and State requirements to do so. The process is, to an
extent, a ``gatekeeper'' that helps prevent unqualified and potentially
fraudulent individuals and entities from being able to enter and
inappropriately bill Medicare. Since 2006, we have taken various steps
via rulemaking to outline our enrollment procedures. These regulations
are generally incorporated in 42 CFR part 424, subpart P (currently
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.
As already mentioned, over the years we have issued various final
rules pertaining to provider and supplier enrollment. These were
intended not only to clarify or strengthen certain components of the
enrollment process but also to enable us to take further action against
providers and suppliers: (1) Engaging (or potentially engaging) in
fraudulent or abusive behavior; (2) presenting a risk of harm to
Medicare beneficiaries or the Medicare Trust Funds; or (3) that are
otherwise unqualified to furnish Medicare services or items. Consistent
therewith, and as further discussed in section VI.B. of this proposed
rule, we propose several changes to our existing provider enrollment
regulations in this proposed rule.
[[Page 35962]]
2. Legal Authorities
There are two principal sources of legal authority for our proposed
provider enrollment provisions. Section 1866(j) of the Act provides
specific authority with respect to the enrollment process for providers
and suppliers. Sections 1102 and 1871 of the Act furnish general
authority for the Secretary to prescribe regulations for the efficient
administration of the Medicare program.
B. Proposed Provisions
1. Effective Dates
We propose to codify in regulation certain effective date practices
discussed in CMS Publication 100-08, Program Integrity Manual (PIM) (or
in other subregulatory guidance). We believe that incorporating these
topics into 42 CFR part 424 would furnish needed clarification and
allow the provider community to furnish public comments thereon.
a. Effective Date of Billing Privileges
Section 424.520 outlines the effective date of billing privileges
for provider and supplier types that are eligible to enroll in
Medicare. Paragraph (d) thereof sets forth the applicable effective
date for physicians, non-physician practitioners (NPP), physician
organizations, NPP organizations, ambulance suppliers, opioid treatment
programs, and home infusion therapy suppliers. This effective date is
the later of: (1) The date of filing of a Medicare enrollment
application that a Medicare contractor subsequently approved; or (2)
the date that the provider or supplier first began furnishing services
at a new practice location. In a similar vein, Sec. 424.521(a) States
that the seven previously mentioned provider and supplier types can
retrospectively bill for services when they have met all program
requirements (including State licensure requirements), and services
were provided at the enrolled practice location for up to--
Thirty days prior to their effective date if circumstances
precluded enrollment in advance of providing services to Medicare
beneficiaries; or
Ninety days prior to their effective date if a
Presidentially-declared disaster under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act (Pub. L. 100-707, enacted November
23, 1988), 42 U.S.C. 5121-5206 (Stafford Act), precluded enrollment in
advance of providing services to Medicare beneficiaries.
In essence, these provisions afford the affected providers and
suppliers a limited ability to ``back bill'' for services furnished
before the contractor approves the provider's or supplier's
application. This reflects CMS' recognition that circumstances can
prevent a provider's or supplier's enrollment prior to the furnishing
of Medicare services. With this in mind, CMS, under the applicable PIM
guidance, had applied the effective date policies in 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.
For the reasons previously discussed, we propose to add these nine
supplier types to the scope of Sec. Sec. 424.520(d) and 424.521(a).
The specific regulatory changes would be as follows.
First, the title and opening paragraph of Sec. 424.520(d)
currently reads: (d) Physicians, non-physician practitioners, physician
and non-physician practitioner organizations, ambulance suppliers,
opioid treatment programs, and home infusion therapy suppliers. The
effective date for billing privileges for physicians, non-physician
practitioners, physician and non-physician practitioner organizations,
ambulance suppliers, opioid treatment programs, and home infusion
therapy suppliers is the later of . . . . Rather than add the nine
aforementioned supplier types to the seven provider and supplier types
already listed within this language (thus making the latter
unnecessarily long), we propose to shorten and simplify the language to
state that the effective date of billing privileges for the provider
and supplier types identified in paragraph (d)(2) of this section is
the later of the following. Consistent with this proposed change, we
would also do the following:
Redesignate existing 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, the title of Sec. 424.521 would be changed from ``Request
for payment by physicians, non-physician practitioners, physician and
non-physician organizations, ambulance suppliers, opioid treatment
programs, and home infusion therapy suppliers'' to ``Request for
payment by certain provider and supplier types.''
Third, the opening language of current Sec. 424.521(a) reads
``Physicians, non-physician practitioners, physician and non-physician
practitioner organizations, ambulance suppliers, opioid treatment
programs, and home infusion therapy suppliers may retrospectively bill
for services when the physician, non-physician practitioner, physician
or non-physician organization, ambulance supplier, opioid treatment
program, or home infusion therapy supplier--.'' We propose to revise
this language to state that the providers and suppliers identified in
paragraph (a)(2) of this section may retrospectively bill for services
when the provider or supplier.
Fourth, we propose to--
Redesignate existing Sec. 424.521(a)(1) and (2) as,
respectively, new Sec. 424.521(a)(1)(i) and (ii); and
List the 16 aforementioned 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. (This frequently occurs when, for
example, a physician joins a group practice and, as a condition of her
employment, reassigns the payments for the services she furnishes on
behalf of the group practice to the latter.) If the reassignor is not
enrolled in Medicare, he or she must complete a Form CMS-855I (OMB
Control No. 0938-0685) application as well as a Form CMS-855R.
Under the applicable PIM guidance, CMS applied the basic principles
of Sec. Sec. 424.520(d) and 424.521(a) to Form CMS-855R reassignments
when establishing the effective date of the latter. As with Sec. Sec.
424.520(d) and 424.521(a), this subregulatory policy was intended to
account for instances where the supplier may have been unable to submit
a Form CMS-855R application earlier than what occurred. To codify this
into regulation, we propose to add a new 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
[[Page 35963]]
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
the physician or other eligible professional indeed wishes to enroll to
order and/or certify these services and/or items but is not seeking
Medicare billing privileges. He or she will accordingly complete the
Form CMS-855O (``Medicare Enrollment Application: Enrollment for
Eligible Ordering, Certifying and Prescribing Physicians and Eligible
Professionals; OMB Control #: 0935-1135). CMS or MAC approval of this
application does not grant billing privileges but only permits the
individual to order/certify the aforementioned services and/or items.
Although the effective date provisions in Sec. Sec. 424.520(d) and
424.521(a) do not (and indeed could not) apply to Form CMS-855O
enrollments because no billing privileges or payments are involved, the
PIM states that a Form CMS-855O enrollment effective date is the date
on which the Medicare contractor received the application (as opposed
to, for instance, the date the contractor approves the application).
This permitted the individual to order/certify these services and items
for a limited period prior to enrollment. To codify this in regulation,
we propose to state the following in new Sec. 424.522(b): ``The
effective date of a Form CMS-855O enrollment is the date on which the
Medicare contractor received the Form CMS-855O application if all other
requirements are met.''
We are also proposing several effective date provisions relating to
the provider enrollment concept of deactivation. These are addressed
within the larger deactivation discussion in section VI.B.3. of this
proposed rule.
2. Rejections and Returns
a. Background and Distinction
Per 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 purpose of the rejection policy is to encourage the provider or
supplier to: (1) Fully and completely submit all required information
(and any required documentation) with their enrollment application; and
(2) promptly respond to any contractor requests for clarification
regarding the application. If a provider's or supplier's application is
rejected (for example, because the provider or supplier did not correct
an error on its application per the contractor's request), the
contractor notifies the provider or supplier via letter accordingly.
The letter outlines, among other things, the reason for the rejection
under Sec. 424.525(a) and informs the provider or supplier that the
latter must submit a new application.
The PIM also discusses the return of provider enrollment
applications. In general, an application has been returned when one of
the return grounds outlined in the PIM applied. These grounds typically
involve situations where the provider's or supplier's submission
constitutes, in essence, a non-application. This is different from a
rejected application in that the latter: (1) Does not automatically
involve an invalid submission yet the application, for instance, failed
to include certain information or documentation or contains erroneous
data; and (2) can be remedied prior to any rejection via the provider's
or supplier's submission of a corrected, revised, supplemented, or
complete application.
We recognize that there has been uncertainty within the provider
community regarding the difference between application rejections and
returns as well as the grounds for both actions. To clarify these
issues, we propose to revise Sec. 424.525 and to add a new Sec.
424.526.
b. Proposed Rejection and Return Policies
(1) Rejections
The three previously mentioned reasons in Sec. 424.525(a) for
rejecting an application are currently designated as, respectively,
paragraphs (a)(1), (a)(2), and (a)(3). We propose to include the
following ten rejection scenarios (almost all of which had been
identified as reasons for rejection in the PIM) within the larger 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 (a)(1) (for instance, furnishing
correct and complete data) within the 30-day period stated therein. We
believe that incorporating these situations within the scope of Sec.
424.525(a)(1) would ease the burden on providers and suppliers because
they would be given time to correct the application's deficiencies. (We
note that, under the current and proposed versions of Sec. 424.525,
CMS may reject an application but is not required to.)
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 email when the
provider or supplier was not otherwise permitted to do so.
The provider or supplier failed to submit all of the forms
needed to process a Form CMS-855 reassignment package within 30 days of
receipt. (For example, a newly enrolling physician who will be
reassigning her benefits to a group practice submits a Form CMS-855R
application but fails to submit an accompanying Form CMS-855I
application.)
The provider or supplier submitted the incorrect Form CMS-
855 application. (For example, the provider submitted a Form CMS-855B
when a Form CMS-855A application (Medicare Enrollment Application;
Institutional Providers; OMB # 0938-0685) was required.)
We reiterate our belief, and it has been our experience, that these
rejection
[[Page 35964]]
scenarios in proposed new Sec. 424.525(a)(1)(i) through (x) involve
situations where the provider or supplier can remedy (and, in many
cases, has remedied) their application submission fairly expeditiously.
(For instance, an unsigned or improperly signed application can be
corrected with the proper signature.) Grounds for application returns,
on the other hand, involve situations that cannot be remedied without
an entirely new application submission because the initial submission
was invalid or otherwise could not be accepted and processed. With both
rejections and returns, however, there are no appeal rights.
Existing Sec. 424.525(b), (c), and (d) address various operational
aspects of our rejection policy. We are not proposing to revise them.
However, and to clarify the scope of Sec. 424.525, we propose 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). This is to help ensure that the provider or supplier
furnishes a correct and complete submission regardless of the type of
CMS enrollment form involved. Concomitant with this change, we propose
to remove the word ``prospective'' from Sec. Sec. 424.525(a)(1),
(a)(2), (a)(3), and (b). This will clarify that these three rejection
grounds apply to enrolled providers and suppliers and not simply
prospective enrollees.
(1) Returns
For reasons already explained, we propose in new 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 opening
language of paragraph (a) would state, however, that CMS or the
Medicare contractor ``may'' return the application in the following
instances but is not required to:
The provider or supplier sent its paper Form CMS-855, Form
CMS-588, or Form CMS-20134 application to the incorrect Medicare
contractor for processing. (For example, the application was sent to
Contractor X instead of Contractor Y.)
The Medicare contractor received the application more than
60 days prior to the effective date listed on the application. (This
does not apply to (1) providers and suppliers submitting a Form CMS-
855A application, (2) ambulatory surgical centers, or (3) portable x-
ray suppliers.
The seller or buyer in a change of ownership submitted its
Form CMS-855A or Form CMS-855B application more than 90 days prior to
the anticipated date of the sale.
The Medicare contractor received an initial application
more than 180 days prior to the effective date listed on the
application from (1) a provider or supplier submitting a Form CMS-855A
application, (2) an ambulatory surgical center, or (3) a portable x-ray
supplier.
The Medicare contractor confirms that the provider or
supplier submitted an initial enrollment application prior to the
expiration of the time period in which it is entitled to appeal the
denial of its previously submitted application.
The provider or supplier submitted an initial enrollment
application prior to the expiration of their existing reenrollment bar
under 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 not yet made a recommendation for approval concerning the
initial application, both applications may be returned in this
scenario.
++ Has made a recommendation for approval concerning the initial
application, the Medicare contractor may return the CHOW application.
If, per the Medicare contractor's written request, the provider or
supplier fails to submit a new initial Form CMS-855A or Form CMS-855B
application containing the new owner's information within 30 days of
the date of the letter, the Medicare contractor may return the
originally submitted initial Form CMS-855A or Form CMS-855B
application.
We note that several of these return grounds involve situations
where the application is submitted prematurely. CMS and its contractors
had previously encountered numerous instances where, for instance, a
Part B supplier would submit an enrollment application well over 9
months before: (1) The practice location effective date that the
supplier listed on their application; and/or (2) the date on which the
supplier planned to begin furnishing services or otherwise commence
operations. Just as frequently, providers and suppliers would submit
initial enrollment applications well in advance of the expiration of
their: (1) Appeal rights following the denial of their previous
application submission; and/or (2) Medicare reenrollment bar following
a revocation. This essentially required contractors to hold and track
the submitted application for many months until the application could
be processed at a time closer to the supplier's commencement date. To
alleviate contractors of this burden, the PIM identified various dates
before which the provider or supplier could not submit an application.
We also propose in Sec. 424.526 to explain certain operational
components of our return policy. First, we propose 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.) Since, as previously stated, we believe the situations
outlined in proposed Sec. 424.526(a) essentially involve the
submission of a non-application, we do not believe appeal rights would
be appropriate. Second, we propose to effectively duplicate proposed
Sec. 424.525(e) in new proposed Sec. 424.526(c). This would clarify
the types of enrollment applications and transactions to which Sec.
424.526 would apply.
[[Page 35965]]
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. Deactivation, in short, is a
less severe action than a revocation but one significant enough to
encourage providers and suppliers to maintain compliance with
enrollment requirements.
There are currently three grounds for deactivation under Sec.
424.540(a), listed as, respectively, paragraphs (a)(1), (a)(2), and
(a)(3):
The provider or supplier does not submit any Medicare
claims for 12 consecutive calendar months.
The provider or supplier does not report a change in its
enrollment information within 90 calendar days of the change. (Changes
in ownership or control must be reported within 30 calendar days.)
The provider or supplier does not furnish complete and
accurate information and all supporting documentation within 90
calendar days of receipt of notification from CMS to submit a
revalidation application in accordance with 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 believe that several
revisions to Sec. 424.540 are needed. In general, these changes are
meant to, as applicable: (1) Clarify existing policies; (2) incorporate
certain subregulatory discussions into Sec. 424.540 to afford
stakeholders an opportunity for public comment; (3) give CMS greater
flexibility in its payment safeguard activities; and (4) reduce
provider and supplier burden.
(b) Grounds for Deactivation
As already mentioned, deactivation is a CMS action that is more
moderate than a revocation. Unlike the latter, a deactivation neither
involves the imposition of a reenrollment bar nor is considered a final
adverse action under Sec. 424.502. It constitutes, in a sense, a
middle ground between CMS imposing a revocation that (under the
circumstances) could be an overly harsh measure and CMS taking no
action at all, thus potentially leaving a program integrity risk
intact. In this manner, it enables us to avoid an ``all-or-nothing''
situation.
We believe that expanding this flexibility to include additional
grounds for deactivation would help CMS achieve a proper medium that
protects the Medicare program without burdening providers and suppliers
with an unwarranted revocation and the consequences thereof. It would,
at CMS' discretion, allow for a third option (besides revocation and
non-action) that might be the fairest and most appropriate given the
facts involved. Accordingly, we propose a number of changes to Sec.
424.540(a) and (b).
First, existing paragraph (a) contains an opening clause followed
by the three existing deactivation reasons, codified as paragraphs
(a)(1), (a)(2), and (a)(3). We propose to add several new deactivation
grounds as paragraphs (a)(4) through (a)(8); respectively, they would
be as follows:
The provider or supplier is not in compliance with all
enrollment requirements in Title 42.
The provider's or supplier's practice location is non-
operational or otherwise invalid.
The provider or supplier is deceased.
The provider or supplier is voluntarily withdrawing from
Medicare.
The provider is the seller in an HHA change of ownership
under Sec. 424.550(b)(1).
Proposed reasons (a)(4) and (a)(5) reflect existing bases for
revocation. We propose including them within Sec. 424.540 because,
depending on the specific circumstances in question, they sometimes
involve relatively modest instances of non-compliance that the provider
or supplier can correct. Reasons (a)(6), (a)(7), and (a)(8) are merely
technical, non-substantive deactivation grounds referenced in
subregulatory guidance; a deactivation in these situations had simply
``closed'' the provider's or supplier's enrollment without the need for
a revocation.
Second, we propose to revise Sec. 424.540(b)(1) to state: ``In
order for a deactivated provider or supplier to reactivate its Medicare
billing privileges, the provider or supplier must recertify that its
enrollment information currently on file with Medicare is correct,
furnish any missing information as appropriate, and be in compliance
with all applicable enrollment requirements in this title.'' The
addition of the language concerning compliance is primarily meant to
account for our addition of Sec. 424.540(a)(4) and (5). The
recertification of enrollment data alone would not be enough for
providers and suppliers deactivated under either of these grounds; they
(or, as applicable, their practice location(s)) must also have resumed
compliance. However, this change would also clarify that compliance
with all enrollment requirements would be required for providers and
suppliers deactivated under Sec. 424.540(a)(1), (a)(2), or (a)(3) to
be reactivated. (We recognize that Sec. 424.540(b)(1) would be largely
inapplicable to proposed deactivation grounds Sec. 424.540(a)(6), (7),
and (8) because the provider or supplier has effectively departed the
Medicare program.)
In new paragraph (d)(1)(i), and consistent with existing policy, we
propose to specify that except as provided in paragraph (d)(1)(ii) of
this section, the effective date of a deactivation is the date on which
the deactivation is imposed under this section. In paragraph
(d)(1)(ii), we propose that CMS may apply a retroactive deactivation
effective date--based on the date that the provider's or supplier's
action or non-compliance occurred or commenced (as applicable)--in the
following instances (which would include our proposed new deactivation
grounds, discussed previously):
++ For deactivation reasons (a)(2), (3), and (4), the effective
date would be
[[Page 35966]]
the date on which the provider or supplier became non-compliant (for
example, the expiration of the period in which the provider was
required to report a change in its enrollment information).
++ For deactivation reason (a)(5), the date on which the provider's
or supplier's practice location became non-operational or otherwise
invalid.
++ For deactivation reason (a)(6), the date of death of the
provider or supplier.
++ For deactivation reason (a)(7), the date on which the provider
or supplier voluntarily withdrew from Medicare.
++ For deactivation reason (a)(8), the date of the sale.
(c) Payment Prohibition
We propose in new 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 believe that
the most sensible approach from a program integrity perspective is to
prohibit such payments altogether. In our view, a provider or supplier
should not be effectively rewarded for its 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 items furnished while out of
compliance; indeed, the prospect of a payment prohibition could well
spur providers and suppliers to avoid such non-compliance. We believe
proposed 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 propose 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.''
While this sentence is true, we previously mentioned other purposes of
deactivation, such as encouraging providers and suppliers to remain
compliant with Medicare requirements. Given the multiple rationales for
the deactivation process, we believe the first sentence of Sec.
424.540(c) is too restrictive and propose to remove it. (The existing
second sentence of Sec. 424.540(c) would remain intact and comprise
the whole of revised paragraph (c).)
Second, and as alluded to previously, the concluding sentence of
existing 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 propose 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. Consequently, we would delete the existing version of this
paragraph and state that deactivation is permitted if the provider or
supplier does not report a change to the information supplied on the
enrollment application within the applicable time period required under
this title. Our use of the word ``title'' would account for provisions
in Title 42 (such as those in Sec. 424.516) that require certain
provider and supplier types to report such changes within the
timeframes specified therein.
Third, under the applicable PIM guidance, the effective date of a
reactivation is generally the date on which the Medicare contractor
received the application that was processed to completion. To clarify
this policy in regulation, we propose to add it as new 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.
6. 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 Medicare contractor 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 propose to insert the phrase ``(if the financial institution
offers such attestations)'' after the term ``financial institution'' as
used Sec. 489.28(d) and (e).
7. HHA Changes of Ownership
Section 424.550(b) states that if there is a change in majority
ownership of an HHA by sale within 36 months after the effective date
of the HHA's initial enrollment in Medicare or within 36 months after
the HHA's most recent change in majority ownership, the HHA's provider
agreement and Medicare billing privileges do not convey to the new
owner (hereafter occasionally referenced as the ``36-month rule'').
Instead, the prospective provider/owner of the HHA must: (1) Enroll in
Medicare as a new (initial) HHA; and (2) obtain a state survey or
accreditation. We had seen situations where an HHA submitted an initial
enrollment application, underwent a Sate survey, became Medicare-
enrolled, and then promptly sold (or ``flipped'') the HHA (via our
change of ownership regulations in Sec. 489.18) to an unqualified
party. This was problematic because the latter would not have to
undergo a new State survey. By effectively imposing a 36-month
``waiting period'' for HHA changes in majority ownership under Sec.
424.550(b), we have been able to stem such instances of ``flipping''
or, if an HHA sale does occur within this timeframe,
[[Page 35967]]
fully scrutinize the new owner via a State survey and the initial
provider enrollment process. This is particularly important given, as
previously mentioned, the heightened program integrity risks that HHAs
have historically presented.
However, we recognize in Sec. 424.550(b) that there are instances
where qualified HHAs change their ownership without any intent to
circumvent a State survey or initial enrollment. Therefore, we created
several exceptions in which the 36-month rule does not apply. One
exception (identified in Sec. 424.550(b)(2)(i)) is that the HHA has
submitted 2 consecutive years of full cost reports; we believe this
circumstance indicates that the HHA has been legitimately and fully
functioning for an extended period, thus negating to some extent our
concern that the HHA may be engaged in ``flipping.'' There has been
uncertainty within the provider community as to whether this particular
exception applies only to the 2-year cost report period after initial
enrollment or also to 2-year cost report periods after the HHA's
previous change in majority ownership. In assessing whether an HHA has
been operational and providing services for 2 consecutive years for
purposes of the 36-month rule, we see no appreciable difference between
a period following initial enrollment and one succeeding a change in
majority ownership. We accordingly propose to revise the first sentence
of 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.)
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.
The individual has a medical prognosis that his or her life expectancy
is 6 months or less if the illness runs its normal course. Under the
Medicare hospice program benefit, the election of hospice program care
is a patient choice and once a terminally ill patient elects to receive
hospice care, a hospice interdisciplinary group (IDG) is essential in
the seamless provision of primarily home-based services.
Hospice programs must comply with applicable civil rights laws,\90\
including section 504 of the Rehabilitation Act of 1973 and the
Americans with Disabilities Act, under which covered entities must take
appropriate steps to ensure effective communication with patients and
patient care representatives with disabilities, including the
provisions of auxiliary aids and services. Additionally, they must take
reasonable steps to ensure meaningful access for individuals with
limited English proficiency, consistent with Title VI of the Civil
Rights Act of 1964. Further information about these requirements may be
found at: http://www.hhs.gov/ocr/civilrights.
---------------------------------------------------------------------------
\90\ 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.
---------------------------------------------------------------------------
1. Medicare Participation and Survey Activity
Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of
the Act, and the implementing regulations in 42 CFR part 418, establish
eligibility requirements, payment standards, and procedures; define
covered services; and delineate the conditions a hospice program must
meet to be approved for participation as a provider in the Medicare
program. Part 418, subpart G, provides for a per diem payment based on
one of four prospectively-determined rate categories of hospice care
(routine home care, continuous home care, inpatient respite care, and
general inpatient care), based on each day a qualified Medicare
beneficiary is under hospice care (once the individual has elected).
This per diem payment is meant to cover all of the hospice services and
items needed to manage the beneficiary's care, as required by section
1861(dd)(1) of the Act.
Section 1864(a) of the Act authorizes the State survey agencies
(SAs) or other appropriate local agencies, under an agreement with CMS,
to perform surveys of health care providers and suppliers to assess
their compliance with the applicable Medicare conditions. There are
several types of surveys conducted, including initial surveys (to
receive initial certification), recertification surveys (to maintain
certification), complaint surveys (to investigate complaints), and
surveys for validation of the results of Accrediting Organization (AO)
surveys. Only the SA or CMS may survey certain provider types because a
CMS-approved AO option does not exist for their type, while others
cannot be surveyed by SAs in accordance with the statute but can only
be accredited by a CMS-approved AO (such as providers of the technical
component of advanced diagnostic imaging). Based on the SA
recommendations from survey findings, CMS determines whether the
provider or supplier qualifies, or continues to qualify, for
participation in the Medicare program.
2. CMS Requirements for AOs Approved To Deem Hospice Programs
Section 1865(a) of the Act allows most health care facilities to
demonstrate their compliance with the Medicare conditions through
accreditation by a CMS-approved program of an AO,
[[Page 35968]]
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 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. Provisions of the Proposed Rule
1. Overview
Division CC, section 407 of the CAA 2021, amended Part A of Title
XVIII of Act to add a new section 1822 to the Act, and amended sections
1864(a) and 1865(b) of the Act, establishing new hospice program survey
and enforcement requirements. There are nine new survey and enforcement
provisions. The law requires public reporting of hospice program
surveys conducted by SAs and AOs, as well as enforcement actions taken
as a result of these surveys, on CMS's website in a manner that is
prominent, easily accessible, searchable and readily understandable
format. It also removes the prohibition at section 1865(b) of the Act
of public disclosure of hospice surveys performed by AOs, requiring
that AOs use the same survey deficiency reports as SAs (Form CMS-2567,
``Statement of Deficiencies'' or a successor form) to report survey
findings. The law requires programs to measure and reduce inconsistency
in the application of survey results among all surveyors. The law
requires the Secretary to provide comprehensive training and testing of
SA and AO hospice program surveyors, including training with respect to
review of written plans of care. The statute prohibits SA surveyors
from surveying hospice programs for which they have worked in the last
2 years or in which they have a financial interest, requires hospice
program SAs and AO to use a multidisciplinary team of individuals for
surveys conducted with more than one surveyor (to include at least one
registered nurse (RN)), and provides that each SA must establish a
dedicated 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 this proposed rule, we are proposing a comprehensive strategy to
enhance the hospice program survey process, increase accountability for
hospice programs, and provide increased transparency to the public. Our
goals include: (1) Maintaining the public trust through addressing
conflicts of interest and improving survey transparency; (2) addressing
inconsistency within the survey process through training and survey
team composition and use of common hospice program deficiency reporting
mechanisms; and (3) ensuring hospice programs are held accountable for
addressing identified health and safety issues. The statutory
requirements outlined in the CAA 2021 will address CMS' goals and are
in the best interest of patients who receive care in Medicare-
participating hospice programs.
We propose to add new subparts M and N to 42 CFR part 488 to
implement the CAA 2021 requirements. Subpart M would provide survey and
certification processes while subpart N would provide the enforcement
remedies for hospice programs with deficiencies that are not in
compliance with Medicare participation requirements. The proposed
enforcement remedies for hospice programs with deficiencies are similar
to the alternative enforcement sanctions available for HHAs with
deficiencies. We propose to amend Sec. 488.2 and Sec. 488.28, where
appropriate, to include the reference to hospice program. In addition,
we propose to amend terminations and appeals requirements in 42 CFR
parts 489 and 498 based on the proposed enforcement remedies.
2. Subpart A--General Provisions
a. Statutory Basis (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
[[Page 35969]]
and enforcement procedures. We propose to amend the requirement at
Sec. 488.2 and at Sec. 498.1 to include this statutory reference to
hospice program services.
b. Application and Re-Application Procedures for National Accrediting
Organizations (Sec. 488.5)
We propose 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.
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
\91\ is the legal, documentary basis for how SAs and CMS Federal
surveyors note findings of compliance or noncompliance (deficiencies)
resulting from an inspection of 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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\91\ CMS-2567 available at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS2567.pdf.
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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).\92\ In mid-
2021, CMS will begin transitioning to the new software system on a
program-specific implementation schedule, starting with HHAs. It may
take several years to fully transition all programs to the new
technology platform, and CMS will continue to evaluate documentation
needs, make necessary system adjustments with each program that
transitions, and train surveyors on system use.
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\92\ iQIES is available at: https://iqies.cms.gov/.
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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 currently assessing the systems revisions needed for each of
the three database options (ASPEN, ASSURE, and iQIES) to determine if
one of the systems could be a future vehicle for hospice program AOs to
document their survey findings in the same manner as SAs and
subsequently have those forms easily captured by CMS for reporting
purposes. Since ASPEN and ASSURE are nearing the end of their
lifecycle, as CMS transitions to iQIES, it may not be prudent for CMS
to invest resources and redistribute funding intended to update the
future system to update legacy systems. At this time, it is most
important for AOs to develop a way of incorporating the Form CMS-2567
into their documentation systems. As their systems are proprietary, CMS
is unable to tell the AOs exactly how to incorporate the Form CMS-2567,
but we will work with the AOs to determine how their version can be
submitted to CMS via electronic data exchange.
Separately from the systems issues, the existing format of the Form
CMS-2567 must be modified, as it does not currently have a place for
the name of the AO that is performing the survey as this form was
historically only used by SAs. Consequently, the form directions do not
refer to AOs. Since this is a public document that is frequently used
by consumers, advocacy groups, and the public as a source of
information about quality of care and facility compliance, CMS must
make updates to the form to include AO information so it is clear who
performed the survey. CMS is in the process of seeking the Office of
Management and Budget (OMB) approval of this revised form for
information collection, in accordance with provisions of the Paperwork
Reduction Act (PRA). For further discussion on PRA implications and
timeline, see the collection of information requirements in section X.
of this proposed rule.
We seek public comment on how AOs can customize their proprietary
systems to incorporate a version of the Form
[[Page 35970]]
CMS-2567 and then submit it to CMS via electronic data exchange.
c. Release and Use of Accreditation Surveys (Sec. 488.7)
We propose 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 survey information
are related to an enforcement action taken by CMS against the provider.
However, CMS may post State agency complaint or validation survey
results of deemed hospice providers; CMS utilizes the Quality,
Oversight, and Certification Reports (QCOR) \93\ public website for
this purpose.
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\93\ Quality, Certification and Oversight Reports (QCOR).
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As mentioned in section VII.B.1.b. of this proposed rule, CMS
recognizes there are challenges related to the system implications for
use of the Form CMS-2567 by the AOs. However, as directed by Congress,
we are removing the prohibition that previously allowed AO hospice
program survey reports to be considered confidential and proprietary.
We are proposing to require that AOs release deficiency reports for
hospice program surveys conducted under their respective deeming
authority to increase transparency among the hospice beneficiary
community.
CMS will need to address various system integrations and updates to
integrate AO survey results on the Form CMS-2567 as mentioned in
section VII.B.2.b. of this proposed rule. Furthermore, CMS recognizes
there are limitations and additional data system changes to consider
for survey results from the Form CMS-2567 to be displayed in a
meaningful and useful format.
We seek public comments as to how data elements from the Form CMS-
2567 may be utilized and displayed, and other recommendations of
relevant provider information, to assist the public in obtaining a more
comprehensive understanding of a hospice program's overall performance.
CAA 2021 requires that CMS publish survey information from the Form
CMS-2567 in a way that is readily understandable and useable by the
public in a meaningful way. We anticipate the need for us to develop
some type of a standard framework that would identify salient survey
findings in addition to other relevant data about the hospices'
performance. We recognize that the implications of releasing national
survey data will require collaboration with industry stakeholders to
assure the development is fair and equitable across all hospice
programs.
d. Providers or Suppliers, Other Than SNFs, NFs, HHAs, and Hospice
Programs With Deficiencies (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 a survey that a
provider or supplier is not in compliance with one or more of the
standards in the CoPs, it is granted a ``reasonable time'' to achieve
compliance. The amount of time depends upon the nature of the
deficiency and the SA's discretionary determination as to whether the
facility can provide adequate and safe care. Ordinarily, a provider or
supplier is expected to take the steps needed to achieve compliance
within 60 days of being notified of the deficiencies. However, the SA
may recommend additional time be granted based on individual situations
if it is not reasonable to expect compliance within 60 days. The
regulation exempts SNFs, NFs, and HHAs from this requirement; instead,
similar provisions are set out in the regulations relating to those
specific provider-types.
Section 1822(c) of the Act authorizes the Secretary to take actions
to ensure the removal and correction of 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 CMS that is the hospice program's written response to
survey findings detailing corrective actions to cited deficiencies and
the hospice program specifies the date by which those deficiencies will
be corrected. We propose revising the heading for Sec. 488.28 to
indicate that hospice programs with deficiencies would also be exempt
from the enforcement requirements set out in that section of our rules.
3. Proposed New Subpart M--Survey and Certification of Hospice Programs
a. Basis and Scope (Sec. 488.1100)
The proposed regulation at Sec. 488.1100 would specify the
statutory authority and general scope of the hospice program. In
general, this proposed rule is based on the rulemaking authority in
section 1822 of the Act as well as specific statutory provisions
identified in the preamble where appropriate.
b. Definitions (Sec. 488.1105)
We propose 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 of this part.
Deficiency would mean a violation of the Act and
regulations contained in 42 CFR part 418, subparts C and D, is
determined as part of a survey, and can be either standard or
condition-level.
Noncompliance would mean any deficiency found at the
condition-level or standard-level.
Standard-level deficiency would mean noncompliance with
one or more of the standards that make up each condition of
participation for hospice programs.
Standard survey would mean a survey conducted in which the
surveyor reviews the hospice program's compliance with a select number
of standards and/or CoPs to determine the quality of care and services
furnished by a hospice program.
Substantial compliance would mean compliance with all
condition-level requirements, as determined by CMS or the State.
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
[[Page 35971]]
later than 36 months after the date of the previous standard survey, as
specified in section 1822(a)(1) of the Act. A survey could be conducted
more frequently than 36 months to assure that the delivery of quality
hospice services complies with the CoPs and confirm that the hospice
program corrected deficiencies that were previously cited. At proposed
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 title; and (2) to receive complaints (and answer questions)
with respect to HHAs and hospice programs in the State or locality.
Section 1864(a) of the Act also provides that such agreements shall
provide for the State or local agency to maintain a unit for
investigating such complaints that possesses enforcement authority and
has access to survey and certification reports, information gathered by
any private accreditation agency utilized by the Secretary under
section 1865 of the Act, and consumer medical records (but only with
the consent of the consumer or his or her legal representative). We
propose to build on these same requirements for hospice programs
consistent with the amendments made to section 1864(a) of the Act by
CAA 2021.
Therefore, at Sec. 488.1110(b)(2) we propose that the State or
local agency is responsible for establishing and maintaining a toll-
free hotline to receive complaints (and answer questions) with respect
to hospice programs in the State or locality and for maintaining a unit
to investigate such complaints. The requirement for the hotline will be
described in the annual CMS Quality, Safety and Oversight Group's
Mission and Priority Document (MPD) that serves as the scope of work
which State Agencies are bound contractually via section 1864 of the
Act (42 U.S.C. 1395aa).
As we plan for the implementation of the hospice toll-free hotline
to streamline and enhance the complaint process for hospice program
beneficiaries, we seek public comment on current experiences with the
HHA toll-free hotline as required by section 1864(a) of the Act. This
information will inform CMS of future enhancements to the toll-free
hotline. Specifically, what data elements and processes should be
included to assure confidentiality and immediate communication with
relevant SAs in order to permit them to respond promptly.
d. Surveyor Qualifications and Prohibition of Conflicts of Interest
(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 propose 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 would be required to complete the online CMS hospice program
basic training. CMS proposes that until the rule is finalized, that it
accept the current AO training, that was previously reviewed and
approved by CMS during the AO application process. State agency
surveyors should already be in compliance with this requirement.
AOs already have voluntary access to our Quality, Safety &
Education Portal (QSEP), which contains the CMS training. Currently,
the trainings are available free of charge through the QSEP website at
https://qsep.cms.gov, to providers and all entities conducting surveys,
including AOs, and the public at large. QSEP training is accessible on
an individual, self-paced basis.
The basic training online courses provide surveyors with the key
knowledge and skills needed to survey the respective provider or
supplier type for compliance with the Medicare conditions and assure an
adequately trained, effective surveyor workforce. The online courses
also help develop and refine surveying skills, promote critical
thinking skills, and enhance surveyors' overall ability to conduct and
document surveys. Users may access the online courses at any time. This
allows surveyors to refresh knowledge regarding Medicare conditions and
processes whenever necessary. The number of learners trained in online
courses has steadily increased since the courses' inception.
We are updating the hospice program basic training and including
enhanced guidance for surveyors. The updated training will emphasize
assessment of quality of care. Specifically, we would emphasize four
``core'' hospice program CoPs in revisions to the CMS State Operations
Manual (SOM) (Pub. 100-07). The four core CoPs (identified in the
preamble of the final rule, Medicare and Medicaid Programs; Hospice
Conditions of Participation (73 FR 32088, June 5, 2008)) are 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
[[Page 35972]]
account on the homepage of the CMS website, or by choosing the ``Public
Access'' button on the upper right-hand corner of the website homepage.
We seek comments on the requirement for continued SA and AO surveyor
training as CMS releases additional basic course updates.
In addition to training requirements for surveyors, we propose to
set out the circumstances that will disqualify a surveyor from
surveying a particular hospice in accordance with section 1822(a)(4)(B)
of the Act. While the statute specifically addresses SA surveyors, CMS
takes prohibiting violations of public trust for those representing the
Medicare program very seriously and therefore we are proposing to
include hospice AO surveyors under this proposed requirement as well.
In 2012, as part of an effort to mitigate conflicts of interest in
the HHA survey process, CMS established requirements at 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.'' \94\
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\94\ 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, a registered nurse (RN) may work on staff at a
hospital but also work at other hospitals through a medical staffing
agency. In addition, as employees of a health care facility, these
health care professionals could gain a financial interest in the health
care facility through means such as being a contributor to the
construction costs of a new wing of the facility or buying stock in the
facility or its parent corporation. Management employees could be
awarded stock or stock options for the facility or its parent
corporation as part of their compensation and benefits package.
SAs and AOs often hire surveyors that are also employed at one or
more outside health care settings because the professional
associations, expertise, knowledge, and skills held by these health
care practitioners make them an asset as a surveyor. Longstanding CMS
policy noted in section 4008 of the SOM describes examples of scenarios
that would be conflicts of interest for SA surveyors of any provider or
supplier type, including surveyors who have an outside relationship
with a facility that is surveyed by the SA. However, the SOM generally
applies only to SA surveyors, not AO surveyors. Therefore, we propose
to codify these long-standing policies for both SA and AO surveyors to
ensure there is no conflict of interest between the organization and
the surveyor.
We propose that a surveyor would be prohibited from surveying a
hospice program if the surveyor currently serves, or within the
previous 2 years has served, on the staff of or as a consultant to the
hospice program undergoing the survey. Specifically, the surveyor could
not have been a direct employee, employment agency staff at the hospice
program, or an officer, consultant, or agent for the surveyed hospice
program regarding compliance with the CoPs. A surveyor would be
prohibited from surveying a hospice program if he or she has a
financial interest or an ownership interest in that hospice. The
surveyor would also be disqualified if he or she has an immediate
family member who has a financial interest or ownership interest with
the hospice program to be surveyed or has an immediate family member
who is a patient of the hospice program to be surveyed.
In regards to the definition of ``immediate family member'' in the
previous statement, we will utilize the definition of ``immediate
family member'' located at 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; and spouse of a grandparent
or grandchild.
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 propose 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, and may include physicians, nurses, medical social workers,
pastoral or other counselors--bereavement, nutritional, and spiritual.
To fulfill CAA 2021 requirements, SAs and AOs might need time to
reconstruct their workforce to accommodate the new requirements for
hospice program surveys to utilize multidisciplinary teams.--We
recognize that SAs and AOs may incur additional costs, given the
varying, and potentially higher rates of average pay for some
disciplines. Surveying entities may need up to a year to hire and train
surveyors from the needed disciplines, depending on the timing of the
attrition of current staff and workforce availability of the
appropriately experienced professionals. In addition, as we proceed
with implementation of this provision, CMS seeks to better understand
the current professional makeup of survey entities' workforces. In
order to track compliance with this provision, we propose to establish
a baseline knowledge by asking survey entities to tell us: (1) The
extent to which their surveys are conducted by one professional, who by
regulation must be a registered nurse; (2) the professional makeup of
their current workforce; and (3) estimate a timeframe in which they
could effectuate multidisciplinary teams if not already in place. We
would provide additional guidance with instruction for the survey
entities regarding the submission of this information to CMS.
Our rules at Sec. 418.56 require that hospice programs use
interdisciplinary teams or groups to determine a holistic plan of care
for the hospice program
[[Page 35973]]
patient and family. The interdisciplinary group or IDG, must include,
but not be limited to a physician, a registered nurse, a medical social
worker, and pastoral or other counselor. Therefore, we propose that
when the survey team comprises more than one surveyor, the additional
slots would be filled by professionals from among these disciplines,
and we are seeking comments on this approach. Similarly, section
1819(g)(2)(E) of the Act and 42 CFR 488.314 require that long-term care
facility surveys be conducted by a multidisciplinary team of
professionals, at least one of whom must be a RN.
Our certification guidance in Chapter 2 of the SOM provides details
as to how the survey agency might select the appropriate disciplines
for a survey team. SOM, Chapter 2 states that various professional
disciplines should represent the expertise needed to determine
compliance with the CoPs, standards, or requirements for that provider/
supplier group. In establishing multidisciplinary teams under new
section 1822(a)(4)(A) of the Act, we would consider, as a model, our
current CMS guidance for long-term care facilities, which uses
specialty surveyors with expertise not typically included in a survey
team (for example, a pharmacist, physician, or registered dietitian),
who may not be needed for the entire survey, but must be onsite at some
time during the survey.
f. Consistency of Survey Results (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 propose 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, CMS expects to promulgate objective measures of survey
accuracy, and seeks public opinion on what measures would be feasible
for States. We desire measures that are both specific and utilize
currently collected data, if possible. Accuracy could include whether a
survey finding aligns with the selected regulatory deficiency, as well
as failing to cite such findings. When applied to survey findings, the
measures should allow CMS to determine the need for corrective action
or education for individual surveyors or for a group of surveyors. If
systemic issues are found, CMS is prepared to enhance its training to
address systemic issues found as a result of interstate analysis.
CMS monitors the consistency of SA surveys through a review of an
SA's Form CMS-2567s (the Statement of Deficiencies and Plan of
Correction), which is conducted by its assigned CMS Survey Operations
Group (SOG) Location, and consistency among AOs through validations
surveys conducted by SAs. The SAs perform validation surveys on a
sample of providers and suppliers (such as hospitals, CAHs, ASCs,
Hospice Programs, and HHAs) accredited by the AOs. Validation surveys
report disparate findings as the percentage of validation surveys that
have conditions identified by the SA but missed by the AO survey team.
This percentage is referred to as the ``disparity rate'' and is tracked
by CMS as an indication of the quality of the surveys performed by the
AO. This is reported annually in a report to Congress (QSO-19-17-AO/
CLIA). The most recent report can be found at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Administrative-Information-Memos-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
propose to analyze trends in the disparity rate among States, as well
as among AOs. State surveys results would be reviewed to identify
findings that were potentially worthy of 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 propose now,
for hospice, is similar to what is done with nursing homes, where
validation surveys are described at section 1819(g)(3)(A) of the Act as
``. . . a representative sample of skilled nursing facilities in each
State, within 2 months of the date of surveys conducted under paragraph
(2) by the State, in a sufficient number to allow inferences about the
adequacies of each State's surveys . . . (B) . . . each year concerning
at least 5 percent of the number of skilled nursing facilities surveyed
by the State in the year, but in no case less than 5 skilled nursing
facilities. . . .'' Even though AOs are not currently included in the
CMS SPSS, we expect that a similar methodology would be applied to all
hospice surveying entities, including AOs with an approved hospice
program. Just as CMS monitors disparate results across States in their
adherence to Federal processes for determining deficiencies,
investigating, and reporting complaints, it requires States to monitor
the quality of its surveyors' survey activity and actions. Performance
measures are applied to all surveying entities to assess consistency.
If CMS finds that surveying entities--SAs and AOs--do not meet the
performance standards, they must develop and implement a corrective
action plan.
The SPSS, established annually, provides for oversight of SA
performance when conducting surveys to ensure that Medicare and
Medicaid certified providers and suppliers are compliant with Federal
CoPs, to improve and protect the health and safety of Americans. This
oversight allows CMS to determine that surveyors are thorough,
accurate, and consistent when they determine if a hospice program
provider is complying with the Medicare CoPs. Survey findings with
respect to a hospice program can include: (1) Standard level
deficiency--where the hospice program is not complying fully with CoPs,
which need corrective action; (2) condition-level deficiencies--which
require remediation and could lead to termination of the hospice
program; or, (3) immediate jeopardy (IJ) level--where beneficiaries are
present in situations where significant harm could occur and which need
to be addressed without delay. SA supervisors are responsible to
[[Page 35974]]
ensure that surveyors `findings (from observations, interviews, and
document reviews) are consistent with their determination of IJ, and
standard- or condition-level deficiency where a hospice program is not
compliant with a condition of participation.
To reduce inconsistencies in survey results among surveyors, CMS
proposes to require agencies that review other entities' survey
findings for missed condition-level deficiency citations (disparities)
(SAs for AOs, and CMS SOG locations for SAs), to notify each survey
entity of its disparity rate annually, and to require a formal
corrective plan as part of the survey entity's (SA or AO) Quality
Assurance program. A disparity rate above 10 percent in 2 consecutive
cycles would trigger remedial activity such as implementing corrective
action through education, mentoring, or other processes to align
surveyors' actions, and determinations of deficiencies with regulatory
requirements.
g. Special Focus Program (SFP) (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 propose 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 propose that
specific criteria would be used to determine whether a hospice program
participates in the SFP. The proposed criteria are as follows: a
history of condition-level deficiencies on two consecutive standard
surveys, two consecutive substantiated complaint surveys, or two or
more condition-level deficiencies on a single validation survey (the
validation survey with condition-level deficiencies would be in
addition to a previous recertification or complaint survey with
condition-level deficiencies). A subset of hospice programs that meet
the proposed criteria would be selected to be in the SFP, and those
hospice programs would be surveyed every 6 months, which may result in
additional enforcement remedies and/or termination. CMS uses a similar
program with long-term care facilities and has outlined the following
protocol for a hospice SFP:
The SA and CMS SOG location would receive a list from CMS
of all hospice programs that meet the established criteria at 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 seek public comment regarding the SFP, specifically the
following issues:
Should CMS utilize a similar criteria/process/frame work
for the SFP as outlined in the current Long-Term Care Program. What if
any differences should CMS considered to enhance the overall impact of
the hospice SFP.
Additional selection criteria that CMS should consider for
the identification and participation in the SFP. This may include use
of current or future data elements that could be incorporated into a
more comprehensive algorithm.
Utilization of a Technical Expert Panel (TEP) to enhance
the SFP in terms of selection, enforcement and technical assistance
criteria while in the program. Furthermore, a TEP may assist CMS by
assisting in identifying contextual data and relevant information to
assist the public in obtaining a more comprehensive understanding of
the Form CMS-2567 survey data and the overall performance of a hospice
provider, in addition to what data to include, how to make this
information useful and meaningful on a CMS website.
4. Proposed New Subpart N--Enforcement Remedies for Hospice Programs
With Deficiencies
a. Statutory Basis (Sec. 488.1200)
We propose 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 compliance with the Medicare requirements (that
is, the failure to meet one or more CoPs is considered to be a lack of
substantial compliance).
b. Definitions (Sec. 488.1205)
We propose 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 propose to use
``remedies'' or ``enforcement remedies,'' which we consider to have the
same meaning and are closer to the language in section 1822 of the Act.
c. General Provisions (Sec. 488.1210)
We propose 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. Our decision to impose one or more remedies, including
termination, will be based on the degree of noncompliance with the
hospice program Federal requirements. With the proposed provisions, CMS
would be able to impose one or more remedies for
[[Page 35975]]
each discrete condition-level deficiency constituting noncompliance.
It is also important to note that hospice programs can acquire
initial certification for participation in Medicare via an SA survey or
via accreditation by a CMS-approved AO. Accreditation by a CMS-approved
AO is voluntary and not necessary to participate in the Medicare
program. If an AO finds deficiencies during an accreditation survey, it
communicates any condition-level findings to the applicable CMS SOG
location. Based on the survey findings, CMS makes any determinations
regarding the imposition of Federal enforcement remedies. An AO cannot
recommend or implement enforcement remedies. In accordance with SOM
Chapter 2, section 2005B, CMS may temporarily remove deemed status of
an accredited hospice program due to condition-level findings found by
the SA or Federal survey team during a complaint or validation survey.
If the deficiencies remain uncorrected, oversight of that hospice
program is transferred to CMS, through the SA, until the hospice
program either demonstrates substantial compliance or CMS terminates
its Medicare participation. In such a case where ``deemed status'' is
removed, CMS will follow the usual procedures for oversight, as
indicated in sections 3254 and 5100 of the SOM. Once an enforcement
remedy is imposed on a formerly accredited hospice program and deemed
status is removed, oversight and enforcement of that hospice program
will be performed by the SA until the hospice program achieves
compliance and the condition(s) causing the noncompliance are removed
or until the hospice program is terminated from the Medicare program.
At proposed Sec. 488.1210(e), a hospice program would be required
to submit an acceptable POC to the SA or CMS within 10 calendar days
from receipt of the statement of deficiencies. This plan is the hospice
program's written response to survey findings detailing corrective
actions to cited deficiencies and the date by which those deficiencies
will be corrected. CMS would determine if the POC was acceptable based
on the information presented.
At proposed Sec. 488.1210(e), we propose the notification
requirements for enforcement remedies for hospice programs that will be
issued by CMS. CMS will provide a notice of intent to the hospice
program that would include the intent to impose a remedy, the statutory
basis for the remedy, the nature of the noncompliance, the intent to
impose a payment suspension and which payments would be suspended (if
applicable), the intent to propose a CMP and the amount being imposed
(if applicable), the proposed effective date of the sanction, and
appeal rights.
We propose that for all remedies imposed, except for CMPs, when
there is IJ the notice period is at least 2 calendar days before the
effective date of the enforcement action and when there is no IJ, that
the notice period is at least 15 calendar days before the effective
date of the enforcement action. As discussed later in this section, we
propose to codify these proposals at Sec. Sec. 488.1225(b) and
488.1230(b), respectively.
With respect to CMPs, we propose that once the administrative
determination to impose the CMP is final, CMS would send a final notice
to the hospice program with the amount of the penalty assessed, the
total number of days of noncompliance (for CMPs imposed per day), the
total amount due, the due date of the penalty, and the rate of interest
to be charged on unpaid balances. We propose to codify these proposals
at Sec. 488.1245(e).
We propose that the hospice program could appeal the determination
of noncompliance leading to the imposition of a remedy under the
provisions of 42 CFR part 498. A pending hearing would not delay the
effective date of the remedy against the hospice program and remedies
will be in effect regardless of any pending appeals proceedings. Civil
money penalties would accrue during the pendency of an appeal, but
would not be collected until the administrative determination is final,
as we note in proposed Sec. 488.1245(f).
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 this proposed rule, we have proposed to
establish requirements for enforcement remedies that may be imposed
when hospice programs are out of compliance with Federal requirements.
At CMS' discretion, these enforcement remedies can be imposed instead
of, or in addition to, termination of the hospice program's
participation in the Medicare program, for a period not to exceed 6
months. The choice of any enforcement remedy or termination would
reflect the impact on patient care and the seriousness of the hospice
program's patterns of noncompliance and would be based on the factors
proposed in 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 IJ situation. We propose 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, CMS proposes to consider the following factors that are
consistent with the factors for HHA alternative sanctions:
The extent to which the deficiencies pose IJ to patient
health and safety.
The nature, incidence, manner, degree, and duration of the
deficiencies or noncompliance.
The presence of repeat deficiencies (defined as condition-
level), the hospice program's compliance history in general, and
specifically concerning the cited deficiencies, and any history of
repeat deficiencies at any of the hospice program's additional
locations.
The extent to which the deficiencies are directly related
to a failure to provide quality patient care.
The extent to which the hospice program is part of a
larger organization with documented performance problems.
Whether the deficiencies indicate a system-wide failure of
providing quality care.
e. Available Remedies (Sec. 488.1220)
Section 1822(c)(5)(A)(ii) of the Act provides that CMS ``shall
develop and implement specific procedures for the conditions under
which each of the remedies developed under clause (i) is to be applied,
including the amount of any fines and the severity of each of these
remedies.'' Section 1822(c)(5)(B) of the Act explicitly provides for
the following enforcement remedies to be included in the range of
remedies: (1) CMPs in an amount not to exceed $10,000 for each day of
noncompliance by a hospice program with the requirements specified in
section
[[Page 35976]]
1861(dd) of the Act; (2) suspension of all or part of the payments to
which a hospice program would otherwise be entitled under this title
for items and services furnished by a hospice program, on or after the
date on which the Secretary determines that remedies should be imposed;
and (3) appointment of temporary management to oversee the operation of
the hospice program and to protect and assure the health and safety of
the individuals under the care of the program while improvements are
made to bring the program into compliance with all such requirements.
In addition to those specified in the statute, we propose to add a
directed POC and directed in-service training as additional enforcement
remedies at Sec. 488.1220.
f. Action When Deficiencies Pose Immediate Jeopardy (Sec. 488.1225)
and Termination (Sec. 489.53)
For situations involving IJ, if CMS determines based on a standard
survey or otherwise that a hospice program's deficiencies involve IJ to
the health and safety of the individuals to whom the program furnishes
items and services, it shall take immediate action to ensure the
removal of the IJ and to correct the deficiencies or terminate the
certification of the program. We are proposing at 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, CMS will
terminate the hospice program's provider agreement. In addition, CMS
could impose one or more enforcement remedies including a CMP,
temporary management, and/or suspension of all or part of Medicare
payments before the effective date of termination.
We propose Sec. 488.1225(b), that for a deficiency or deficiencies
that pose IJ, CMS would provide the hospice program with at least 2
days advance notice of any proposed remedies, except CMPs (discussed at
proposed 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
CMS will give hospice programs written notice of an impending
enforcement actions against them as quickly as possible following the
completion of a survey of any kind.
For terminations, CMS will give notice of the termination within 2
days before the effective date of the termination, to hospice programs
consistent with the requirement for HHAs. We also propose to amend
Sec. 489.53(a)(17) to indicate that we will terminate a hospice
program's (as well as an HHA's) provider agreement if the hospice
program failed to correct a deficiency or deficiencies within the
required time frame.
Finally, at proposed Sec. 488.1225(c), we propose to require a
hospice program whose provider agreement is terminated to appropriately
and safely transfer its patients to another local hospice program
within 30 days of termination, unless a patient or caregiver chooses to
remain with the hospice program as a self-pay or with another form of
insurance (for example, private insurance). In addition, the hospice
program would be responsible for providing information, assistance, and
any arrangements necessary for the safe and orderly transfer of its
patients.
g. Action When Deficiencies Are at the Condition-Level But Do Not Pose
Immediate Jeopardy (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 hospice program's participation in
the Medicare program. If, after such a period of remedies, the program
is still not in compliance with all requirements, the Secretary shall
terminate the hospice program's participation in the Medicare program.
In this proposed rule, enforcement remedies, such as those proposed
in 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 will end when the hospice
program corrects all condition-level deficiencies or is terminated from
the Medicare program.
We propose at Sec. 488.1230, that for a deficiency or deficiencies
that do not pose IJ, CMS will provide the hospice program at least 15
days advance notice of any proposed remedies, except for CMPs
(discussed at proposed 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).
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 propose at Sec. 488.1205,
``temporary management'' means the temporary appointment by CMS or a
CMS authorized agent, of a substitute manager or administrator, who
would be under the direction of the hospice program's governing body
and who would have authority to hire, terminate or reassign staff,
obligate hospice program funds, alter hospice program procedures, and
manage the hospice program to correct deficiencies identified in the
hospice program's operation. The substitute manager or administrator
would be appointed based on qualifications described in Sec. 418.100
and Sec. 418.114 and would be under the direction of the hospice
program's governing body.
We propose 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
propose to specify the duration and effect of this enforcement remedy,
and the payment procedures for temporary managers' salaries and other
additional costs. CMS would provide the hospice program with written
notice of our intent to impose a temporary management remedy in
accordance with proposed Sec. 488.1210(e).
At Sec. 488.1235(a), we propose that temporary management would be
imposed when a hospice program is determined to have condition-level
deficiencies and that the deficiencies or
[[Page 35977]]
the management limitations of the hospice program are likely to impair
the hospice program's ability to correct the deficiencies and return
the hospice program to compliance with all of the CoPs within the
required timeframe. We propose at 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 propose at Sec. 488.1235(b) if the hospice program refuses to
relinquish authority and control to the temporary manager, CMS will
terminate the hospice program's provider agreement. If a temporary
manager was appointed, but the hospice program failed to correct the
condition-level deficiencies within 6 months from the last day of the
survey, the hospice program's Medicare participation would be
terminated. Additionally, if the hospice program resumes management
control without CMS's approval, we would impose termination and could
impose additional enforcement remedies. The appointment of a temporary
manager would not relieve the hospice program of its responsibility to
achieve and maintain compliance with the participation requirements. We
propose at 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 will not exceed a period of 6 months
from the date of the survey identifying noncompliance.
At Sec. 488.1235, we propose that temporary management would be
required to be provided at the hospice program's expense. Before the
temporary manager was installed, the hospice program would have to
agree to pay his/her salary directly for the duration of the
appointment. We believe that the responsibility for the hospice program
to pay the expenses of the temporary manager is an inherent management
responsibility of the hospice agency for which Medicare regularly
reimburses the hospice program and through such temporary outside
management might be necessary in some cases to bring the hospice
program back into compliance with the CoPs. We are proposing that the
salary for the temporary manager would not be less than the amount
equivalent to the prevailing salary paid by providers in the geographic
area for positions of this type, based on the Bureau of Labor
Statistics, National Occupational Employment and Wage Estimates. In
addition, the hospice program would have to pay for any additional
costs that the hospice program may have incurred if such person had
been in an employment relationship, and any other costs incurred by
such a person in furnishing services under such an arrangement or as
otherwise set by the State. CMS would consider a hospice program's
failure to pay the salary of the temporary manager to be a failure to
relinquish authority and control to temporary management.
i. Suspension of Payment for All or Part of the Payments (Sec.
488.1240)
We propose in Sec. 488.1240 provisions describing when and how we
would apply a suspension of payment of all or part of the payments for
items and services furnished by a hospice program on or after the date
on which the Secretary determines that remedies should be imposed under
Sec. 488.1225 or Sec. 488.1230. If a hospice program has a condition-
level deficiency or deficiencies (regardless of whether or not an IJ
exists), we may suspend payments for all or part of the payments to
which a hospice program would otherwise be entitled for items and
services furnished by a hospice program on or after the effective date
of the enforcement remedy. CMS will determine whether to impose a
suspension of all or part of the payments based on the factors outlined
in proposed Sec. 488.1215 that are considered when selecting remedies.
The suspension of payment is proposed at Sec. 488.1240 to be for a
period not exceed 6 months and would end when the hospice program
either achieved substantial compliance or was terminated. CMS would
provide the hospice program with written notice of our intent to impose
a payment suspension remedy at least 2 calendar days before the
effective date of the remedy in IJ situations, per proposed 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 payment of all or part of the payments to which the hospice program
would otherwise be entitled.
Additionally, section 1822(c)(5)(C)(ii) of the Act provides that a
suspension of payment remedy shall terminate when CMS finds that the
hospice program is in substantial compliance with the requirements
specified in, or developed in accordance with, section 1861(dd) of the
Act. That is, the suspension of payment remedy will end when the
hospice program is determined to have corrected all condition-level
deficiencies, or upon termination, whichever is earlier. We propose to
codify that duration of the remedy at 488.1240(c).
j. CMPs (Sec. 488.1245)
We propose 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. CMS
proposes to impose a CMP against a hospice program that is determined
to be out of compliance with one or more CoPs, regardless of whether
the hospice program's deficiencies pose IJ to patient health and
safety. CMS could also impose a CMP for the number of days of IJ. Under
section 1822(c)(5)(B)(i) of the Act, the CMP amount cannot exceed
$10,000 for each day of noncompliance. Our proposals align with the
imposition of CMPs authorized by section 1891(f) of the Act as set out
for HHAs at Sec. 488.845, which CMS may impose against an HHA that is
determined to be out of compliance with one or more CoPs, regardless of
whether the HHA's deficiencies pose IJ to patient health and safety.
In this section, we are proposing both ``per day'' and ``per
instance'' CMPs at 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 propose to impose a CMP for that instance or those
individual instances of noncompliance. We propose 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 CMS to impose a remedy.
While there may be a single event that leads to noncompliance,
there can also be more than one instance of noncompliance identified
and more than one CMP imposed during a survey. For penalties imposed
per instance of noncompliance, we are proposing penalties from $1,000
to $10,000 per instance. Such penalties would be
[[Page 35978]]
assessed for one or more singular events of condition-level
noncompliance that were identified at the survey and where the
noncompliance was corrected during the onsite survey.
Since the range of possible deficiencies is great and depends upon
the specific circumstances at a particular time, it would be impossible
to assign a specific monetary amount for each type of noncompliance
that could be found. Thus, we believe that each deficiency would fit
into a range of CMP amounts.
We are proposing that, in addition to those factors that we would
consider when choosing a type of remedy proposed in 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, CMS would have the discretion to
increase or reduce the amount of the CMP during the period of
noncompliance, depending on whether the level of noncompliance had
changed at the time of a revisit survey. However, section
1822(c)(5)(B)(i) of the Act specifies that the remedies shall include a
CMP in an amount not to exceed $10,000 for each day of noncompliance.
Therefore, we are proposing at 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
propose to establish a three-tier system with subcategories that would
establish the amount of a CMP.
In proposed Sec. 488.1245(b)(3), (b)(4), and (b)(5), we propose
ranges of CMP amounts based on three levels of seriousness--upper,
middle, and lower:
Upper range--For a deficiency that poses IJ to patient
health and safety, we would assess a penalty within the range of $8,500
to $10,000 per day of condition-level noncompliance.
Middle range--For repeat and/or a condition-level
deficiency that did not pose IJ, but is directly related to poor
quality patient care outcomes, we would assess a penalty within the
range of $1,500 up to $8,500 per day of noncompliance with the CoPs.
Lower range--For repeated and/or condition-level
deficiencies that did not constitute IJ and were deficiencies in
structures or processes that did not directly relate to poor quality
patient care, we would assess a penalty within the range of $500 to
$4,000 per day of noncompliance.
The proposed CMP amounts would be subject to annual adjustments for
inflation in accordance with the Federal Civil Monetary Penalty
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the
Federal Civil Penalties Inflation Adjustment Act Improvements Act of
2015 (section 701 of Pub. L. 114-74). Annually adjusted amounts are
published at 45 CFR part 102.
Under the proposed provisions, if CMS imposed a CMP, CMS would send
the hospice program written notification of the intent to impose it,
including the amount of the CMP being imposed and the proposed
effective date of the sanction, under proposed Sec. Sec. 488.1210(e)
and 488.1245(c). Once the administrative determination is final, we
propose to send a final notice to the hospice program with the amount
of the penalty that was assessed; the total number of days of
noncompliance (for per day CMPs); the total amount due; the due date of
the penalty; and the rate of interest to be charged on unpaid balances.
Whether per instance or per day CMPs are imposed, once the hospice
program has received the notice of intent to impose the CMP, it would
have 60 calendar days from the receipt of the written notice of intent
to either request an administrative hearing in accordance with 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 propose at Sec.
488.1245(d) that in IJ cases, if the IJ is not removed, the CMP would
continue to accrue until CMS terminated the provider agreement (within
23 calendar days after the last day of the survey which first
identified the IJ). Under proposed 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 CMS terminated the provider
agreement.
As noted elsewhere, in no instance would a period of noncompliance
be allowed to extend beyond 6 months from the last day of the survey
that initially determined noncompliance. If the hospice program has not
achieved compliance with the CoPs within those 6 months, we would
terminate the hospice program. The accrual of per-day CMPs would stop
on the day the hospice program provider agreement was terminated or the
hospice program achieved substantial compliance, whichever was earlier.
The total CMP amounts would be computed and collected after an
administrative determination is final and a final notice sent to the
hospice program as described in Sec. 488.1245(e).
We also propose that for a hospice program being involuntarily
terminated and for which a civil money penalty had been imposed and was
still due, we would include the final notice, also known as a due and
payable notice, as part of the termination notice. In other words, the
information in a final notice, as described in 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;
CMS received a request from the hospice program waiving
its right to appeal the initial determination;
A final decision of an Administrative Law Judge or
Appellate Board of the Departmental Appeals Board upheld CMS's
determinations; or
The hospice program was terminated from the program and no
appeal request was received.
A request for a hearing would not delay the imposition of the CMP,
but would only affect the collection of any final amounts due to CMS.
[[Page 35979]]
k. Directed Plan of Correction (Sec. 488.1250)
We propose 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 correction of deficient practices.
Specifically, we propose that CMS may impose a directed POC on a
hospice program that is out of compliance with the CoPs. A directed POC
remedy would require the hospice program to take specific actions to
bring the hospice program back into compliance and correct the
deficient practice(s). As indicated in Sec. 488.1250(b)(2) a hospice
program's directed POC would be developed by CMS or by the temporary
manager, with CMS approval. The directed POC would set forth the
outcomes to be achieved, the corrective action necessary to achieve
these outcomes and the specific date the hospice program would be
expected to achieve such outcomes. The hospice program would be
responsible for achieving compliance. If the hospice program failed to
achieve compliance within the timeframes specified in the directed POC,
CMS could impose one or more additional enforcement remedies until the
hospice program achieved compliance or was terminated from the Medicare
program. Before imposing this remedy, CMS would provide appropriate
notice to the hospice program under Sec. 488.1210(e).
l. Directed In-Service Training (Sec. 488.1255)
We propose 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 are proposing that hospice programs use
in-service programs conducted by instructors with an in-depth knowledge
of the area(s) that would require specific training, so that positive
changes would be achieved and maintained. Hospice programs would be
required to participate in programs developed by well-established
education and training services. These programs would include, but not
be limited to, schools of medicine or nursing, area health education
centers, and centers for aging. CMS will only recommend possible
training locations to a hospice program and not require that the
hospice program utilize a specific school/center/provider. In
circumstances where the hospice is subject to the SFP, additional
technical assistance and/or resources could be made available. The
hospice program would be responsible for payment for the directed in-
service training for its staff. At proposed Sec. 488.1255(b), if the
hospice program did not achieve substantial compliance after such
training, CMS could impose one or more additional remedies. Before
imposing this remedy, CMS would provide appropriate notice to the
hospice program under proposed Sec. 488.1210(e).
m. Continuation of Payments to a Hospice Program With Deficiencies
(Sec. 488.1260)
We propose 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 will continue for 6 months if--
An enforcement remedy or remedies (with the exception of
suspension of all payments) have been imposed on the hospice program
and termination has not been imposed;
The hospice program has submitted a POC which has been
approved by CMS; and
The hospice program agrees to repay the Federal government
the payments received under this arrangement should the hospice program
fail to take the corrective action as outlined in its approved POC in
accordance with the approved plan and timetable for corrective action.
We propose these three criteria at 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. CMS would also terminate the
agreement before the end of the 6-month correction period, which begins
on the last day of the survey, in accordance with 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 propose at Sec. 488.1230(d) that we
would terminate the provider agreement.
n. Termination of Provider Agreement (Sec. 488.1265)
At Sec. 488.1265(a), we propose to address the termination of a
hospice program's Medicare provider agreement, as well as the effect of
such termination. Termination of the provider agreement would end all
payments to the hospice program, including any payments that were
continued at the proposed 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), CMS would terminate the provider agreement
if--(1) the hospice program failed to correct condition-level
deficiencies within 6 months unless the deficiencies constitute IJ; (2)
the hospice program failed to submit an acceptable POC; (3) the hospice
program failed to relinquish control of the temporary manager (if that
remedy is imposed); or (4) the hospice program failed to meet the
eligibility criteria for continuation of payments. At Sec. 488.1265(d)
we propose 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 propose 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)).
VIII. Requests for Information
A. Fast Healthcare Interoperability Resources (FHIR) in Support of
Digital Quality Measurement in Post-Acute Care Quality Reporting
Programs--Request for Information
1. Background
A goal of the HH QRP is to improve the quality of health care for
beneficiaries through measurement, transparency, and public reporting
of data. The HH QRP contributes to improvements in health care,
enhancing patient outcomes, and informing consumer choice. In October
2017, we launched the Meaningful Measures Framework. This framework
captures our vision to address health care quality priorities and gaps,
including emphasizing digital quality
[[Page 35980]]
measurement (dQM), reducing measurement burden, and promoting patient
perspectives, while also focusing on modernization and innovation. The
scope of the Meaningful Measures Framework has evolved to Meaningful
Measure 2.0 to accommodate the changes in the health care environment,
initially focusing on measure and burden reduction to include the
promotion of innovation and modernization of all aspects of quality, t
is a need to streamline our approach to data collection, calculation,
and reporting to fully leverage clinical and patient-centered
information for measurement, improvement, and learning.
In alignment with the Meaningful Measures 2.0, we are seeking
feedback on our future plans to define digital quality measures for the
HH QRP. We also are seeking feedback on the potential use of Fast
Healthcare Interoperable Resources (FHIR) for dQMs within the HH QRP
aligning where possible with other quality programs. FHIR is an open
source standards framework (in both commercial and government settings)
created by Health Level Seven International (HL7[supreg]) that
establishes a common language and process for all health information
technology.
2. Definition of Digital Quality Measures
We are considering adopting a standardized definition of dQMs in
alignment across the QRPs including the HH QRP. We are considering in
the future to propose the adoption within the HH QRP the following
definition: ``Digital Quality Measures'' (dQMs) are quality measures
that use one or more sources of health information that are captured
and can be transmitted electronically via interoperable systems.\95\ A
dQM includes a calculation that processes digital data to produce a
measure score or measure scores. Data sources for dQMs may include
administrative systems, electronically submitted clinical assessment
data, case management systems, electronic health records (EHRs),
instruments (for example, medical devices and wearable devices),
patient portals or applications (for example, for collection of
patient-generated health data), health information exchanges (HIEs) or
registries, and other sources. As an example, the quality measures
calculated from patient assessment data submitted electronically to CMS
would be considered digital quality measures.
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\95\ Definition taken from the CMS Quality Conference 2021.
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3. Use of FHIR for Future dQMs in the HH QRP
Over the past years in other quality programs, we have focused on
opportunities to streamline and modernize quality data collection and
reporting processes, such as exploring HL7[supreg] FHIR[supreg] (http://hl7.org/fhir) for other quality programs. One of the first areas CMS
has identified relative to improving our digital strategy is through
the use of FHIR-based standards to exchange clinical information
through application programming interfaces (APIs), allowing clinicians
to digitally submit quality information one time that can then be used
in many ways. We believe that in the future proposing such a standard
within the HH QRP could potentially enable collaboration and
information sharing, which is essential for delivering high-quality
care and better outcomes at a lower cost.
We are currently evaluating the use of FHIR based APIs to access
assessment data collected and maintained through the Quality
Improvement and Evaluation System (QIES) and internet QIES (iQIES)
health information systems and are working with healthcare standards
organizations to assure that their evolving standards fully support our
assessment instrument content. Further, as more Post-Acute Care
providers, including HHAs, are adopting EHRs, we are evaluating using
the FHIR interfaces for accessing patient data (including standard
assessments) directly from HHA EHRs. Accessing data in this manner
could also enable the exchange of data for purposes beyond data
reporting to CMS, such as care coordination further increasing the
value of EHR investments across the healthcare continuum. Once
providers map their EHR data to a FHIR API in standard FHIR formats it
could be possible to send and receive the data needed for measures and
other uses from their EHRs through FHIR APIs.
4. Future Alignment of Measures Across Reporting Programs, Federal and
State Agencies, and the Private Sector
We are committed to using policy levers and working with
stakeholders to achieve interoperable data exchange and to transition
to full digital quality measurement in our quality reporting programs.
We are considering the future potential development and staged
implementation of a cohesive portfolio of dQMs across our regulated
programs, including HHQRP, agencies, and private payers. This cohesive
portfolio would require, where possible, alignment of: (1) Measure
concepts and specifications including narrative statements, measure
logic, and value sets, and (2) the individual data elements used to
build these measure specifications and calculate the measures. Further,
the required data elements would be limited to standardized,
interoperable elements to the fullest extent possible; hence, part of
the alignment strategy will be the consideration and advancement of
data standards and implementation guides for key data elements. We
would coordinate closely with quality measure developers, Federal and
State agencies, and private payers to develop and maintain a cohesive
dQM portfolio that meets our programmatic requirements and that fully
aligns across Federal and State agencies and payers to the extent
possible.
We intend this coordination to be ongoing and allow for continuous
refinement to ensure quality measures remain aligned with evolving
healthcare practices and priorities (for example, patient reported
outcomes (PROs), disparities, care coordination), and track with the
transformation of data collection. This includes conformance with
standards and health IT module updates, future adoption of technologies
incorporated within the ONC Health IT Certification Program and may
also include standards adopted by ONC (for example, standards-based
APIs). The coordination would build on the principles outlined in HHS'
National Health Quality Roadmap.\96\
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\96\ Department of Health and Human Services. National Health
Quality Roadmap. May 15, 2020. Available at: https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
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It would focus on the quality domains of safety, timeliness,
efficiency, effectiveness, equitability, and patient-centeredness. It
would leverage several existing Federal and public-private efforts
including our Meaningful Measures 2.0 Framework; the Federal Electronic
Health Record Modernization (DoD/VA); the Core Quality Measure
Collaborative, which convenes stakeholders from America's Health
Insurance Plans (AHIP), CMS, the Consensus-Based Entity under section
1890 of the Act, provider organizations, private payers, and consumers
and develops consensus on quality measures for provider specialties;
and the NQF-convened Measure Applications Partnership (MAP) which
reviews measures submitted to the Measures Under Consideration (MUC)
list and makes recommendations on whether or not to use them in
Medicare programs.'' We would coordinate with HL7's ongoing work to
advance FHIR
[[Page 35981]]
resources in critical areas to support patient care and measurement
such as social determinants of health. Through this coordination, we
would identify which existing measures could be used or evolved to be
used as dQMs, in recognition of current healthcare practice and
priorities.
This multi-stakeholder, joint Federal, State, and industry effort,
made possible and enabled by the pending advances towards
interoperability, would yield a significantly improved quality
measurement enterprise. The success of the dQM portfolio would be
enhanced by the degree to which the measures achieve our programmatic
requirements as well as the requirements of other agencies and payers.
5. Solicitation of Comments
We seek input on the following steps that would enable
transformation of CMS' quality measurement enterprise to be fully
digital:
What EHR/IT systems do you use and do you participate in a
health information exchange (HIE)?
How do you currently share information with other
providers and are there specific industry best practices for
integrating SDOH screening into EHRs?
What ways could we incentivize or reward innovative uses
of health information technology (IT) that could reduce burden for
post-acute care settings, including but not limited to HHAs?
What additional resources or tools would post-acute care
settings, including but not limited to HHAs, and health IT vendors find
helpful to support testing, implementation, collection, and reporting
of all measures using FHIR standards via secure APIs to reinforce the
sharing of patient health information between care settings?
Would vendors, including those that service post-acute
care settings, including but not limited to HHAs, be interested in or
willing to participate in pilots or models of alternative approaches to
quality measurement that would align standards for quality measure data
collection across care settings to improve care coordination, such as
sharing patient data via secure FHIR API as the basis for calculating
and reporting digital measures?
We plan to continue working with other agencies and stakeholders to
coordinate and to inform our transformation to dQMs leveraging health
IT standards. While we will not be responding to specific comments
submitted in response to this Request for Information in the CY 2022
Home Health PPS final rule, we will actively consider all input as we
develop future regulatory proposals or future subregulatory policy
guidance. Any updates to specific program requirements related to
quality measurement and reporting provisions would be addressed through
separate and future notice- and-comment rulemaking, as necessary.
B. Closing the Health Equity Gap in Post-Acute Care Quality Reporting
Programs--Request for Information
1. Background
Significant and persistent inequities in health outcomes exist in
the United States. In recognition of persistent health disparities and
the importance of closing the health equity gap, we request information
on expanding several related CMS programs to make reporting of health
disparities based on social risk factors and race and ethnicity more
comprehensive and actionable for providers and patients. Belonging to a
racial or ethnic minority group; living with a disability; being a
member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+)
community; or being near or below the poverty level, is often
associated with worse health
outcomes.97 98 99 100 101 102 103 104 Such disparities in
health outcomes are the result of number of factors, but importantly
for CMS programs, although not the sole determinant, poor access and
provision of lower quality health care contribute to health
disparities. For instance, numerous studies have shown that among
Medicare beneficiaries, racial and ethnic minority individuals often
receive lower quality of care, report lower experiences of care, and
experience more frequent hospital readmissions and operative
complications.105 106 107 108 109 110 Readmission rates for
common conditions in the Hospital Readmissions Reduction Program are
higher for black Medicare beneficiaries and higher for Hispanic
Medicare beneficiaries with Congestive Heart Failure and Acute
Myocardial Infarction.111 112 113 114 115 Studies have also
shown that African Americans are significantly more likely than white
Americans to die prematurely from heart disease and stroke.\116\ The
COVID-19 pandemic has further illustrated many of these longstanding
health inequities with higher rates of infection, hospitalization, and
mortality among black, Hispanic, and Indigenous and Native American
persons relative to white persons.117 118
[[Page 35982]]
As noted by the Centers for Disease Control ``long-standing systemic
health and social inequities have put many people from racial and
ethnic minority groups at increased risk of getting sick and dying from
COVID-19''.\119\ One important strategy for addressing these important
inequities is by improving data collection to allow for better
measurement and reporting on equity across our programs and policies.
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\97\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA. 2011;
305(7):675-681.
\98\ Lindenauer PK, Lagu T, Rothberg MB, et al. Income
Inequality and 30 Day Outcomes After Acute Myocardial Infarction,
Heart Failure, and Pneumonia: Retrospective Cohort Study. British
Medical Journal. 2013; 346.
\99\ Trivedi AN, Nsa W, Hausmann LRM, et al. Quality and Equity
of Care in U.S. Hospitals. New England Journal of Medicine. 2014;
371(24):2298-2308.
\100\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
\101\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018.
\102\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\103\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\104\ 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.
\105\ Martino, SC, Elliott, MN, Dembosky, JW, Hambarsoomian, K,
Burkhart, Q, Klein, DJ, Gildner, J, and Haviland, AM. Racial,
Ethnic, and Gender Disparities in Health Care in Medicare Advantage.
Baltimore, MD: CMS Office of Minority Health. 2020.
\106\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\107\ Singh JA, Lu X, Rosenthal GE, Ibrahim S, Cram P. Racial
disparities in knee and hip total joint arthroplasty: An 18-year
analysis of national Medicare data. Ann Rheum Dis. 2014
Dec;73(12):2107-15.
\108\ Rivera-Hernandez M, Rahman M, Mor V, Trivedi AN. Racial
Disparities in Readmission Rates among Patients Discharged to
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
\109\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\110\ Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day
readmission rates for Medicare beneficiaries by race and site of
care. Ann Surg. Jun 2014;259(6):1086-1090.
\111\ Rodriguez F, Joynt KE, Lopez L, Saldana F, Jha AK.
Readmission rates for Hispanic Medicare beneficiaries with heart
failure and acute myocardial infarction. Am Heart J. Aug
2011;162(2):254-261 e253.
\112\ Centers for Medicare and Medicaid Services. Medicare
Hospital Quality Chartbook: Performance Report on Outcome Measures;
2014.
\113\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\114\ Prieto-Centurion V, Gussin HA, Rolle AJ, Krishnan JA.
Chronic obstructive pulmonary disease readmissions at minority-
serving institutions. Ann Am Thorac Soc. Dec 2013;10(6):680-684.
\115\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\116\ HHS. Heart disease and African Americans. (March 29,
2021). https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\117\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\118\ 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/.
\119\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
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We are committed to achieving equity in health care outcomes for
our beneficiaries by supporting providers in quality improvement
activities to reduce health inequities, enabling beneficiaries to make
more informed decisions, and promoting provider accountability for
health care disparities.120 121 For the purposes of this
rule, we are using a definition of equity established in Executive
Order 13985, as ``the consistent and systematic fair, just, and
impartial treatment of all individuals, including individuals who
belong to underserved communities that have been denied such treatment,
such as Black, Latino, and Indigenous and Native American persons,
Asian Americans and Pacific Islanders and other persons of color;
members of religious minorities; lesbian, gay, bisexual, transgender,
and queer (LGBTQ+) persons; persons with disabilities; persons who live
in rural areas; and persons otherwise adversely affected by persistent
poverty or inequality.'' \122\ We note that this definition was
recently established by the current administration, and provides a
useful, common definition for equity across different areas of
government, although numerous other definitions of equity exist.
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\120\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\121\ 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.
\122\ 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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Our ongoing commitment to closing the equity gap in CMS quality
programs is demonstrated by a portfolio of programs aimed at making
information on the quality of health care providers and services,
including disparities, more transparent to consumers and providers. The
CMS Equity Plan for Improving Quality in Medicare aims to support
Quality Improvement Networks and Quality Improvement Organizations
(QIN-QIOs); Federal, State, local, and tribal organizations; providers;
researchers; policymakers; beneficiaries and their families; and other
stakeholders in activities to achieve health equity. The CMS Equity
Plan includes three core elements: (1) Increasing understanding and
awareness of disparities; (2) developing and disseminating solutions to
achieve health equity; and (3) implementing sustainable actions to
achieve health equity.\123\ The CMS Quality Strategy and Meaningful
Measures Framework \124\ include elimination of racial and ethnic
disparities as a fundamental principle. Our ongoing commitment to
closing the health equity gap in the HH QRP is demonstrated by seeking
to adopt through future rulemaking Standardized Patient Assessment Data
Elements under the HH QRP which include several social determinants of
health (SDOH).
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\123\ Centers for Medicare & Medicaid Services Office of
Minority Health. The CMS Equity Plan for Improving Quality in
Medicare. https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
\124\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.
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We continue to work with Federal and private partners to better
collect and leverage data on social risk to improve our understanding
of how these factors can be better measured in order to close the
health equity gap. Among other things, we have developed an Inventory
of Resources for Standardized Demographic and Language Data Collection
\125\ and supported collection of specialized International
Classification of Disease, 10th Edition, Clinical Modification (ICD-10-
CM) codes for describing the socioeconomic, cultural, and environmental
determinants of health. We continue to work to improve our
understanding of this important issue and to identify policy solutions
that achieve the goals of attaining health equity for all patients.
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\125\ Centers for Medicare and Medicaid Services. Building an
Organizational Response to Health Disparities Inventory of Resources
for Standardized Demographic and Language Data Collection. 2020.
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Collection-Resources.pdf.
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2. Solicitation of Public Comment
Under authority of the IMPACT Act and section 1895(b)(3)(B)(v) of
the Act, we are seeking comment on the possibility of expanding measure
development, and the collection of other Standardized Patient
Assessment Data Elements that address gaps in health equity in the HH
QRP. Any potential SPADE or measure reporting related to health equity
data under the HH QRP that might result from public comments received
in response to this solicitation would be addressed through a separate
notice- and-comment rulemaking in the future.
Specifically, we are inviting public comment on the following:
As finalized in the CY 2020 HH PPS final rule (84 FR 60597
through 60608), HHAs will be required to report Standardized Patient
Assessment Data Elements on certain SDOH, including, ethnicity,
preferred language, interpreter services, health literacy,
transportation and social isolation.\126\ CMS is seeking guidance on
any additional Standardized Patient Assessment Data Elements that could
be used to assess health equity in the care of HHA patients, for use in
the HH QRP.
---------------------------------------------------------------------------
\126\ In response to the COVID-19 PHE, CMS released an May 8,
2020 interim final rule with comment period (85 FR 27595 through
27597) which delayed the compliance date for the collection and
reporting of the SDOH for at least 2 full fiscal years after the end
of the PHE.
---------------------------------------------------------------------------
Recommendations for how CMS can promote health equity in
outcomes among HHA patients. We are also interested in feedback
regarding whether including HHA-level quality measure results
stratified by social risk factors and social determinants of health
(for example, dual eligibility for Medicare and Medicaid, race) in
confidential feedback reports could allow HHAs to identify gaps in the
quality of care they provide (for example, methods similar or analogous
to the CMS Disparity Methods \127\ which provide hospital-level
confidential results stratified by dual eligibility for condition-
specific readmission measures currently included in the Hospital
Readmission Reduction Program (84 FR 42496 through 42500).
---------------------------------------------------------------------------
\127\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
---------------------------------------------------------------------------
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
[[Page 35983]]
of health to support care delivery and decision-making.
While we will not be responding to specific comments submitted in
response to this Request for Information in the CY 2022 HH PPS final
rule, we intend to use this input to inform future policy development.
We look forward to receiving feedback on these topics, and note for
readers that responses to the RFI should focus on how they could be
applied to the HH QRP requirements. Please note that any responses
provided will not impact payment decisions.
IX. Revised Compliance Date for Certain Reporting Requirements Adopted
for Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care
Hospital (LTCH) QRP
A. Proposed Revised Compliance Date for Certain Inpatient
Rehabilitation Facility (IRF) QRP Reporting Requirements
1. Background
In IFC-2 (85 FR 27550), we delayed the compliance date for certain
reporting requirements under the IRF QRP (85 FR 27595 through 27596).
Specifically, we delayed the requirement for IRFs to begin reporting
the Transfer of Health (TOH) Information to Provider-PAC and the TOH
Information to Patient-PAC measures and the requirement for IRFs to
begin reporting certain Standardized Patient Assessment Data Elements
from October 1, 2020 to October 1st of the year that is at least one
full fiscal year after the end of the COVID-19 PHE. CMS also delayed
the adoption of the updated version of the IRF Patient Assessment
Instrument (PAI) V4.0 with which IRFs would have used to report the TOH
measures and certain Standardized Patient Assessment Data Elements.
Under IFC-2, IRFs must use the IRF-PAI V4.0 to begin collecting
data on the two TOH Information measures beginning with discharges on
October 1st of the year that is at least one full fiscal year after the
end of the COVID-19 PHE. IRFs must also begin collecting data on
certain Standardized Patient Assessment Data Elements on the IRF-PAI
V4.0, beginning with admissions and discharges (except for the hearing,
vision, race, and ethnicity Standardized Patient Assessment Data
Elements, which would be collected at admission only) on October 1st of
the year that is at least one full fiscal year after the end of the
COVID-19 PHE. The delay to begin collecting data for these measures was
intended to provide relief to IRFs from the added burden of
implementing an updated instrument during the COVID-19 PHE. We wanted
to provide maximum flexibilities for IRFs to respond to the public
health threats posed by the COVID-19 PHE, and to reduce the burden in
administrative efforts associated with attending trainings, training
their staff, and working with their vendors to incorporate the updated
assessment instruments into their operations.
At the time we finalized the policy in the IFC-2, we believed that
the delay in collection of the TOH Information measures and
Standardized Patient Assessment Data Elements would not have a
significant impact on the IRF QRP. However, the COVID-19 PHE showed the
important need for theses TOH Information measures and Standardized
Patient Assessment Data Elements under the HH QRP. The PHE's
disproportionate impact demonstrates the importance of analyzing this
impact and the needs for these populations in order to improve quality
of care within IRFs especially during a public health emergency.
2. Current Assessment of IRFs
To accommodate the COVID-19 PHE, CMS has provided additional
guidance and flexibilities, and as a result IRFs have had the
opportunity to adopt new processes and modify existing processes to
accommodate the significant health crisis presented by the COVID-19
PHE. For example, CMS held regular ``Office Hours'' conference calls to
provide IRFs regular updates on the availability of supplies, as well
as answer questions about delivery of care, reporting and billing. CMS
also supported PAC providers, including IRFs, by providing
flexibilities in the delivery of care in response to the PHE, such as
modifying the required face-to-face visits in IRF to be completed by
telehealth (42 CFR 412.622(a)(3)(iv) and 412.29(e)) during the PHE for
COVID-19, and waiving the post-admission physician evaluation
requirement at Sec. 412.622(a)(4)(ii). In the FY 2021 IRF PPS final
rule (86 FR 48445 through 48447), CMS 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.\128\ We also believe that
much more is known about COVID-19 than at the time CMS finalized IFC-
2.129 130 131 132
---------------------------------------------------------------------------
\128\ CDC COVID Data Tracker. Retrieved from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\129\ 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.
\130\ COVID research: A year of scientific milestones. Nature.
May 5, 2021. Retrieved from: https://www.nature.com/articles/d41586-020-00502-w.
\131\ 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.
\132\ COVID-19 Treatment Guidelines. National Institutes of
Health. Updated April 21, 2021. Retrieved from: https://www.covid19treatmentguidelines.nih.gov/whats-new/.
---------------------------------------------------------------------------
Based upon other flexibilities such as the previous examples, the
increase in knowledge IRF providers have about treating patients with
COVID-19 \133\ since finalizing IFC-2, and the trending data on COVID-
19, IRFs are in a better position to accommodate reporting of the TOH
measures and certain (Social Determination of Health) Standardized
Patient Assessment Data Elements. Also, recent reports (not available
at the time CMS IFC-2 was finalized) suggest that IRFs have the
capacity to begin reporting the TOH measures and certain Social
Determinant of Health (SDOH) Standardized Patient Assessment Data
Elements.\134\
---------------------------------------------------------------------------
\133\ 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/.
\134\ https://www.healthaffairs.org/do/10.1377/hblog20201214.543463/full/.
---------------------------------------------------------------------------
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).
[[Page 35984]]
3. Proposal To Collect the Transfer of Health Information to Provider-
PAC Measure, the Transfer of Health Information to Patient-PAC Measure,
and Certain Standardized Patient Assessment Data Elements Beginning
October 1, 2022
We are proposing to revise the compliance date from IFC-2 to
October 1, 2022. This revised date would begin the collection of data
on the Transfer of Health Information to Provider-PAC measure and
Transfer of Health Information to Patient-PAC measure, and certain
Standardized Patient Assessment Data Elements on the updated version of
the IRF-PAI assessment instrument referred to as IRF-PAI V4.0. This
revised date of October 1, 2022, which is a 2-year delay from the
original compliance date finalized in the FY 2020 IRF PPS final rule
(84 FR 39054 through 39173), balances the support that IRFs needed
during much of the COVID-19 PHE as CMS provided flexibilities to
support IRFs along with the need to collect this important data.
The need for the Standardized Patient Assessment Data Elements and
TOH Information measures have been shown to be even more pressing with
issues of inequities the COVID-19 PHE laid bare. This data that
includes addressing SDOH provides information expected to improve
quality of care for all. Consequently, we are proposing to revise the
compliance date to reflect this balance and assure that data collection
begins on October 1, 2022.
As stated in the FY 2020 IRF PPS final rule, CMS will provide the
training and education for IRFs to be prepared for this implementation
(84 FR 39119 through 39147). In addition, if CMS adopts an October 1,
2022 compliance date, CMS would release a draft of the updated version
of the IRF-PAI, IRF-PAI V4.0, in early 2022.
Based upon our evaluation, we propose that IRFs would collect the
Transfer of Health Information to Provider-PAC measure, the TOH
Information to the Patient-PAC measure, and certain Standardized
Patient Assessment Data Elements beginning October 1, 2022.
Accordingly, we propose that IRFs would begin collecting data on the
two TOH measures beginning with discharges on October 1, 2022. We also
propose that IRFs would begin collecting data on the six categories of
Standardized Patient Assessment Data Elements on the IRF-PAI V4.0,
beginning with admissions and discharges (except for the hearing,
vision, race, and ethnicity Standardized Patient Assessment Data
Elements, which would be collected at admission only) on October 1,
2022.
We invite public comment on these proposals.
B. Proposed Revised Compliance Date for Certain Long-Term Care Hospital
(LTCH) QRP Reporting Requirements
1. Background
In IFC-2 (85 FR 27550), we delayed the compliance date for certain
reporting requirements under the LTCH QRP (85 FR 27595 through 27596).
Specifically, we delayed the requirement for LTCHs to begin reporting
the TOH Information to Provider-PAC measure and the TOH Information to
Patient-PAC measure and the requirement for LTCHs to begin reporting
certain Standardized Patient Assessment Data Elements from October 1,
2020 to October 1st of the year that is at least one full fiscal year
after the end of the COVID-19 PHE. CMS also delayed the adoption of the
updated version of the LTCH Continuity Assessment and Record of
Evaluation (CARE) Data Set (LCDS) V5.0 with which LTCHs would have used
to report the TOH measures and certain Standardized Patient Assessment
Data Elements.
Under IFC-2, LTCHs must use the LCDS V5.0 to begin collecting data
on the two TOH Information measures beginning with discharges on
October 1st of the year that is at least one full fiscal year after the
end of the COVID-19 PHE. LTCHs must also begin collecting data on
certain Standardized Patient Assessment Data Elements on the LCDS V5.0,
beginning with admissions and discharges (except for the hearing,
vision, race, and ethnicity Standardized Patient Assessment Data
Elements, which would be collected at admission only) on October 1st of
the year that is at least one full fiscal year after the end of the
COVID-19 PHE. The delay to begin collecting data for these measures was
intended to provide relief to LTCHs from the associated burden of
implementing an updated instrument during the COVID-19 PHE. We wanted
to provide maximum flexibilities for LTCHs to respond to the public
health threats posed by the COVID-19 PHE, and to reduce the burden in
administrative efforts associated with attending trainings, training
their staff, and working with their vendors to incorporate the updated
assessment instruments into their operations.
At the time we finalized the policy in the IFC-2, we believed that
the delay in collection of the TOH Information measures, and
Standardized Patient Assessment Data Elements would not have a
significant impact on the LTCH QRP. However, the COVID-19 PHE showed
the important need for theses TOH Information measures and Standardized
Patient Assessment Data Elements under the LTCH QRP. The PHE's
disproportionate impact on minority populations demonstrates the
importance of analyzing this impact and the needs for these populations
in order to improve quality of care within LTCHs especially during a
public health emergency.
2. Current Assessment of LTCHs
To accommodate the COVID-19 PHE, CMS has provided additional
guidance and flexibilities, and as a result LTCHs have had the
opportunity to adopt new processes and modify existing processes to
accommodate the significant health crisis presented by the COVID-19
PHE. For example, CMS held regular ``Office Hours'' conference calls to
provide LTCHs regular updates on the availability of supplies, as well
as answer questions about delivery of care, reporting and billing. CMS
also supported PAC providers, including LTCHs, by providing
flexibilities in the delivery of care in response to the PHE, such as
waiving requirement at 42 CFR 482.43(a)(8), 482.61(e), and
485.642(a)(8) to provide detailed information regarding discharge
planning. To address workforce concerns related to COVID-19, CMS waived
requirements under 42 CFR 482.22(a)(1) through (4) to allow for
physicians whose privileges would expire to continue practicing at the
hospital and for new physicians to be able to practice before full
medical staff/governing body review and approval. In addition, as of
June 9, 2021, 63.8 percent of all the adult population has received at
least one vaccination, and COVID-19 cases and deaths have steadily
declined over the last 60 days.\135\ We also believe that much more is
known about COVID-19 than at the time CMS finalized IFC-
2.136 137 138 139
---------------------------------------------------------------------------
\135\ CDC COVID Data Tracker. Retrieved from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\136\ 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.
\137\ COVID research: A year of scientific milestones. Nature.
May 5, 2021. Retrieved from: https://www.nature.com/articles/d41586-020-00502-w.
\138\ 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.
\139\ COVID-19 Treatment Guidelines. National Institutes of
Health. Updated April 21, 2021. Retrieved from: https://www.covid19treatmentguidelines.nih.gov/whats-new/.
---------------------------------------------------------------------------
[[Page 35985]]
Based upon other flexibilities such as the previous examples, the
increase in knowledge LTCH providers have about treating patients with
COVID-19 \140\ since finalizing IFC-2, and the trending data on COVID-
19, LTCHs are now in a better position to accommodate reporting of the
TOH measures and certain Standardized Patient Assessment Data
Elements.\141\
---------------------------------------------------------------------------
\140\ 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/.
\141\ https://www.healthaffairs.org/do/10.1377/hblog20201214.543463/full/.
---------------------------------------------------------------------------
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. Proposal To Collect the Transfer of Health Information to Provider-
PAC Measure, the Transfer of Health Information to Patient-PAC Measure,
and Certain Standardized Patient Assessment Data Elements Beginning
October 1, 2022
We are proposing to revise the compliance date from IFC-2 to
October 1, 2022. This revised date would begin the collection of data
on the Transfer of Health Information to Provider-PAC measure and
Transfer of Health Information to Patient-PAC measure, and certain
Standardized Patient Assessment Data Elements on the updated version of
the LCDS V5.0. This revised date of October 1, 2022, which is a two-
year delay from this original compliance date finalized in the FY 2020
IPPS/LTCH PPS final rule (84 FR 42044 through 42701), balances the
support that LTCHs needed during much of the COVID-19 PHE as CMS
provided flexibilities to support LTCHs along with the need to collect
this important data.
The need for the Standardized Patient Assessment Data Elements and
TOH Information measures have been shown to be even more pressing with
issues of inequities the COVID-19 PHE laid bare. This data that
includes addressing SDOH provides information expected to improve
quality of care for all. Consequently, we are proposing to revise the
compliance date to reflect this balance and assure that data reporting
begins on October 1, 2022.
As stated in the FY 2020 IPPS/LTCH PPS final rule, CMS will provide
the training and education for LTCHs to be prepared for this
implementation (84 FR 42540 through 42560). In addition, if CMS adopts
an October 1, 2022 compliance date, CMS would release a draft of the
updated version of the LCDS, LCDS V5.0, in early 2022.
Based upon our evaluation, we propose that LTCHs would collect the
Transfer of Health Information to Provider-PAC measure, the Transfer of
Health Information to the Patient-PAC measure, and certain Standardized
Patient Assessment Data Elements, beginning on October 1, 2022. We
propose that accordingly, LTCHs would begin collecting data on the two
TOH measures beginning with discharges on October 1, 2022. We also
propose that LTCHs would begin collecting data on the six categories of
Standardized Patient Assessment Data Elements on the LCDS V5.0,
beginning with admissions and discharges (except for the hearing,
vision, race, and ethnicity Standardized Patient Assessment Data
Elements, which would be collected at admission only) on October 1,
2022.
We invite public comment on these proposals.
X. Collection of Information Requirements
A. Statutory Requirement for Solicitation of Comments
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
In this proposed rule, we are soliciting public comment on each of
these issues for the following sections of this document that contain
information collection requirements (ICRs).
B. Collection of Information Requirements
1. HH QRP
In section IV.C. of this propose rule, we propose changes and
updates to the HH QRP. We believe that the burden associated with the
HH QRP proposals is the time and effort associated with data quality
and reporting. As of March 1, 2021, there are approximately 11,400 HHAs
reporting quality data to CMS under the HH QRP. For the purposes of
calculating the costs associated with the information collection
requirements, we obtained mean hourly wages for these from the U.S.
Bureau of Labor Statistics' May 2020 National Occupational Employment
and Wage Estimates (https://www.bls.gov/oes/current/oes_nat.htm). To
account for overhead and fringe benefits (100 percent), we have doubled
the hourly wage. These amounts are detailed in Table 35.
[[Page 35986]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.054
In section IV.C.4.a. of the proposed rule, we are proposing to
remove the Drug Education on All Medications Provided to Patient/
Caregiver during All Episodes of Care measure under removal factor 1,
measure performance among HHAs is so high and unvarying that meaningful
distinctions in improvements in performance can no longer be made.
Additionally, we are proposing to remove the OASIS item M2016 used to
calculate this measure. This item removal will result in a decrease in
overall burden.
In sections IV.C.4.b. and c. of the proposed rule, we are proposing
to adopt the Home Health Within Stay Potentially Preventable
Hospitalization claims-based measure. We are proposing to replace the
Acute Care Hospitalization During the First 60 Days of HH (NQF #0171)
measure and the Emergency Department Use without Hospitalization During
the First 60 Days of HH (NQF #0173) measure with the Within Stay
Potentially Hospitalization measure beginning with the CY 2023 HH QRP
under our measure removal factor 6: A measure that is more strongly
associated with desired patient outcomes for the particular topic is
available. Because the measures are claims-based, the replacement/
removal will not impact collection of information.
Therefore, we are proposing a net reduction of 1 data element at
the Discharge from Agency time point and 1 data element at the Transfer
of Care time point associated with OASIS item (M2016) collection as a
result of the measure removal. We assume that each data element
requires 0.3 minutes of clinician time to complete. Therefore, we
estimate that there would be a reduction in clinician burden per OASIS
assessment of 0.3 minutes at Discharge from Agency and 0.3 minutes at
Transfer of Care.
The OASIS is completed by RNs or PTs, or very occasionally by
occupational therapists (OTs) or speech language pathologists (SLT/SP).
Data from 2020 show that the OASIS is completed by RNs (approximately
76.5 percent of the time), PTs (approximately 20.78 percent of the
time) and other therapists including OTs and SLP/STs (approximately
2.72 percent of the time). Based on this analysis, we estimated a
weighted estimated clinician average hourly wage of $79.41, inclusive
of fringe benefits using the wage data from Table 35. Individual
providers determine the staffing necessary.
Table 36 shows the total number of assessments submitted in CY 2020
and estimated costs at each time point.
[GRAPHIC] [TIFF OMITTED] TP07JY21.055
Based on the data in Table 35 and Table 36 for the 11,400 active
Medicare-certified HHAs, we estimate the total decrease in costs
associated with the changes in the HH QRP at approximately $242 per HHA
annually or $2,762,277 for all HHAs. This corresponds to an estimated
decrease in clinician burden associated proposed changes to the HH QRP
of approximately 3.1 hours per HHA or approximately 34,785 hours for
all HHAs. This decrease in burden would be accounted for in the
information collection under OMB control number 0938-1279 (Expiration
date: 12/31/2021).
In section IV.C. of this proposed rule, we propose a revised
compliance date for certain reporting requirements adopted for the HH
QRP. The burden for the proposed revision to the HH QRP requirements as
adopted in the CY 2020 HH PPS final rule (84 FR 60632 through 60642)
has been accounted for in OMB control number 0938-1279. Therefore, this
proposal would not affect the information collection burden already
established.
[[Page 35987]]
2. ICRs Regarding Revised Compliance Dates for Certain Reporting
Requirements
a. IRF QRP Requirements
In section VIII.A. of this proposed rule, we propose to revise the
compliance date for certain reporting requirements adopted for the IRF
QRP. We believe that the burden associated with the IRF QRP proposal is
the time and effort associated with reporting quality data. As of April
4, 2021, there are approximately 1,109 IRFs reporting quality data to
CMS. The burden for the proposed revision to the IRF QRP requirements
as adopted in the FY 2020 IRF PPS final rule (84 FR 39165 through
39172) has been accounted for in OMB control number 0938-0842
(Expiration date: 12/31/2022). Therefore, this proposal would not
affect the information collection burden for the IRF QRP.
b. LTCH QRP Requirements
In section VIII.B. of this proposed rule, we propose a revised
compliance date for certain reporting requirements adopted for the LTCH
QRP. We believe that the burden associated with the LTCH QRP proposal
is the time and effort associated with reporting quality data. As of
April 21, 2021, there are approximately 363 LTCHs reporting quality
data to CMS. The burden for the proposed revision to the LTCH QRP
requirements as adopted in the FY 2020 IPPS/LTCH PPS final rule (84 FR
42602 through 42656) has been accounted for in OMB control number 0938-
1163 (expiration12/31/2022). Therefore, this proposal would not affect
the information collection burden for the LTCH QRP.
3. ICRs Related to the Changes in the Home Health CoPs
a. ICRs Related to the Virtual Supervision of HHA Aides
In section IV.D. of this propose rule, we would revise 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 propose to revise 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 meet the patient's needs. The home health aide
does not need to be present during this visit. We are also proposing
that the RN would make a semi-annual on-site (in-person) visit to the
location where a patient is receiving care in order to observe and
assess the home health aide while he or she was performing care. This
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. Section 484.80(h) also requires HHAs to document the
supervision of home health aides in accordance with specified
timeframes. In addition, we believe the modification proposed at Sec.
484.80(h)(3) includes retraining and competency evaluations related to
both the skills verified as deficient and to any related skills will
not add any information collection burden and will enhance the
provisions of safe, quality home health services. In accordance with
the implementing regulation of the PRA at 5 CFR 1320.3(b)(2), we
believe that both the existing requirements and the proposed revisions
to the requirements at 484.80(h) are exempt from the PRA. We believe
competency evaluations are a usual and customary business practice and
we state as such in the information collection request associated with
the Home Health CoPs (OMB control number: 0938-1299/Expiration: 06/30/
2021). Therefore, we are not proposing to seek PRA approval for any
information collection or recordkeeping activities that may be
conducted in connection with the proposed revisions to Sec. 484.80(h),
but we request public comment on our determination that the time and
effort necessary to comply with these evaluation requirements is usual
and customary, and would be incurred by home health staff even absent
this regulatory requirement.
b. ICRs Related to Permitting Occupational Therapist To Complete the
Initial and Comprehensive Assessments for Home Health Agencies
In section IV.D. of this proposed rule, we would implement Division
CC, section 115 of CAA 2021 by proposing conforming regulations text
changes at 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 also not initially on the home health plan of care. These
changes permit occupational therapists to complete these assessments
even though the need for occupational therapy would not establish the
patient's eligibility for the Medicare home health benefit. In
accordance with the implementing regulations of the PRA at 5 CFR
1320.3(b)(2), we believe that both the existing requirements and the
proposed revisions to the requirements at 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
are not proposing to seek PRA approval for any information collection
or recordkeeping activities that may be conducted in connection with
the proposed revisions to Sec. 484.55(a)(2) and (b)(3), but we request
public comment on our determination that the time and effort necessary
to comply with these evaluation requirements is usual and customary and
would be incurred by home health staff even absent this regulatory
requirement.
4. ICRs Regarding Medicare Provider and Supplier Enrollment Provisions
We do not anticipate any information collection burden associated
with our provider and supplier enrollment proposals. Since most of
these proposals have been in subregulatory guidance for a number of
years and we are simply incorporating them into regulation, there would
not be any change in burden on the provider community. Those provisions
that are not in subregulatory guidance do not implicate information
collection requirements.
5. ICRs Regarding Survey and Enforcement Requirements for Hospices
a. Wage Data
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2020 National Occupational Employment and Wage
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 37 presents the mean hourly wage,
the cost of fringe benefits and
[[Page 35988]]
overhead (calculated at 100 percent of salary), and the adjusted hourly
wage.
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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.
The current information collection request for the form CMS-2567,
titled ``Statement Of Deficiencies And Plan Of Correction'' (OMB
control number 0938-0391/Expiration date: 6/30/2021) does not account
for any information collection related burden associated with AO use.
As discussed in the preamble of this proposed rule, in section
VII.B.2.b. of this proposed rule, we note that the currently approved
Form CMS-2567 does not include a place for the name of the AO
completing the survey and AOs are not addressed in the instructions.
These are minor revisions to the form but we will submit the revised
information collection request to OMB for approval.
We discussed in the preamble section VII.B.2.b. of this proposed
rule, how AOs conduct hospice program surveys and gather deficiency
findings into a report that is provided to the surveyed hospice. CMS
believes the statutory requirement and subsequent proposed rule for the
inclusion of Form CMS-2567 would not add significant burden to AOs as
they already develop deficiency finding reports as part of their
existing process just in a different format. We note that AOs would
need to make a one-time update to their existing proprietary electronic
documentation systems to include the Form CMS-2567. We estimate that
this task would be performed by a computer and information analyst.
According to the U.S Bureau of Labor statistics, the mean hourly wages
for a computer and information analyst is $48.40. This wage adjusted
for the employer's fringe benefits and overhead would be $96.80.
We estimate that it would take at least two persons working on a
full-time basis for 3 days for the AO staff to revise their system to
add the required Form CMS-2567. Therefore, we estimate that the total
time required for the two team members to perform this task would be 48
hours. As of March 2021, there are three AOs that accredit Medicare
certified hospice programs. The total time burden across these three
AOs would be 144 hours.
We estimate that the cost burden related to the work performed by
two computer and information analysts would be $4,646.50 (24 hours x
$193.60 ($96.80 x 2)). The total cost across the three AOs would be
$13,939.50 (3 AOs x $4,646.50). The burden associated with this
requirement will be submitted to OMB under OMB control number 0938-NEW
(Expiration date: pending). We seek comments that would help us to
develop an accurate estimate of the cost and time burden that would
result from this collection of information.
These are minor revisions to the form; however, as required under
the PRA we will be seeking OMB approval for a revised version of the
form. Please note, we will be seeking OMB approval via the required
notice and comment periods but they will be separate from this proposed
rulemaking. The revised information collection request will be
announced in the Federal Register and the public will have the
opportunity to review and comment as necessary.
c. Surveyor Qualifications and Prohibition of Conflicts of Interest
(Sec. 488.1115)
We proposed at Sec. 488.1115, to require AO surveyors to complete
the online hospice basic training. As discussed in the preamble section
VII.B.2.d. of this proposed rule, we note there are multiple online
training programs available to SA surveyors on the CMS QSEP website.
These courses are self-paced, slide based presentations and the person
taking the course can take the courses over a period of time. The
amount of time required to complete each of these training courses
varies depending on the pace at which the surveyor is able to read
through or listen to the presentation and complete the training.
Duration time is based on the estimate that it takes learners
approximately 2 minutes per slide. This information is publicly
available on https://qsep.cms.gov/welcome.aspx. We proposed that each
AO hospice program surveyor take the hospice basic training course that
has an average completion time of 24 hours. Completion time could be
more or less depending upon the learner's familiarity with the content
and overall learning style. Therefore, a hospice program AO surveyor
would incur a time burden of approximately 24 hours for the completion
of this CMS surveyor training course.
The AOs that accredit Medicare certified hospice programs would
incur a cost burden for the wages of their surveyors for the time they
spend taking these online surveyor training courses. Most surveyors are
clinicians such as RNs.
As noted, we estimated that it would take approximately 24 hours
for each AO surveyor to complete the hospice basic training online
surveyor course. Therefore, the AO would incur wages in the amount of
$1,846.56 per each surveyor that completes the CMS online surveyor
training (24 hours x $76.94).
We are not able to precisely estimate total time and cost burden to
each AO for the wages incurred for the time spent by all surveyors from
each of the three hospice program AOs to take the CMS online surveyor
training course, because each AO varies greatly in organization
[[Page 35989]]
size, number of accreditation programs approved by CMS, and total
surveyor cadre numbers. There are no regulatory requirements for AOs to
report to CMS on the number of surveyors within their organization nor
information on how many of those surveyors survey each type of program
approved by CMS. CMS notes there is a wide variety of total surveyor
cadre numbers across all three AOs, based on information CMS has
gathered from confidential numbers, voluntarily provided by some of the
AOs to CMS, as part of their deeming authority application documents as
well as information found online via a search of each AOs public
website. Variation is generally based on the associated number of CMS-
approved accreditation programs the AO possesses. For example, AOs who
accredit only one provider or supplier type generally have about 25
surveyors while AOs with multiple programs have surveyor numbers well
over 300 thereby skewing the ability to estimate an accurate time
burden that represents the overall group. Because of this wide range
CMS is estimating near the middle, using 100 total surveyors per AO. If
we estimate that each AO has approximately 100 total surveyors, the
estimated time burden to each AO associated with this requirement would
be 2,400 hours (24 hours x 100 surveyors).
The estimated cost burden to each AO (that accredits Medicare-
certified hospice programs) associated with this requirement would be
$184,656 (2,400 hours x $76.94 per hour). The burden associated with
this requirement will be submitted to OMB under OMB control number
0938-NEW (Expiration date: pending).
As of March 2021, there are three AOs that accredit Medicare-
certified hospice programs. We estimate that the time burden across all
of these AOs associated with the requirement that their surveyors take
the CMS online surveyor training would be 7,200 hours (2,400 hours x 3
AOs).
The estimated cost across all AOs (that accredit Medicare-certified
hospice programs) would be $553,968 ($184,656 x 3 AOs). We request
feedback on the total number of AO hospice program surveyors we should
consider, especially if our estimate of 100 is grossly under or over
estimated.
6. HHVBP Expanded Model
In section III. of this proposed rule, we propose policies
necessary to implement the expanded Home Health Value-Based Purchasing
Model (see proposed 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.
C. Submission of PRA-Related Comments
We have submitted a copy of this proposed rule to OMB for its
review of the rule's information collection and recordkeeping
requirements. The requirements are not effective until they have been
approved by OMB.
We invite public comments on these information collection
requirements. If you wish to comment, please identify the rule (CMS-
1747-P) and, where applicable, the preamble section, and the ICR
section. See this rule's DATES and ADDRESSES sections for the comment
due date and for additional instructions.
XI. Regulatory Impact Analysis
A. Statement of Need
1. HH PPS
Section 1895(b)(1) of the Act requires the Secretary to establish a
HH PPS for all costs of home health services paid under Medicare. In
addition, section 1895(b) of the Act requires: (1) The computation of a
standard prospective payment amount include all costs for home health
services covered and paid for on a reasonable cost basis and that such
amounts be initially based on the most recent audited cost report data
available to the Secretary; (2) the prospective payment amount under
the HH PPS to be an appropriate unit of service based on the number,
type, and duration of visits provided within that unit; and (3) the
standardized prospective payment amount be adjusted to account for the
effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B)
of the Act addresses the annual update to the standard prospective
payment amounts by the home health applicable percentage increase.
Section 1895(b)(4) of the Act governs the payment computation. Sections
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard
prospective payment amount to be adjusted for case-mix and geographic
differences in wage levels. Section 1895(b)(4)(B) of the Act requires
the establishment of appropriate 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
[[Page 35990]]
not deny or limit the coverage or provision of benefits. On January 8,
2021, we announced that the HHVBP Model (the original Model) had been
certified for expansion nationwide,\142\ as well as our intent to
expand the Model through notice and comment rulemaking beginning no
sooner than CY 2022. The original Model has resulted in an average 4.6
percent improvement in home health agencies' quality scores as well as
average annual savings of $141 million to Medicare. The CMS Chief
Actuary has determined that HHVBP Model would reduce Medicare
expenditures if expanded to all States.
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\142\ https://www.cms.gov/files/document/certification-home-health-value-based-purchasing-hhvbp-model.pdf.
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If finalized, all Medicare-certified HHAs in the 50 States,
District of Columbia and the territories would be required to
participate in the expanded HHVBP Model beginning January 1, 2022.
These HHAs would compete on value based on an array of quality measures
that capture the services provided by HHAs. The savings impacts related
to the HHVBP Model expansion are estimated at a total projected 5-year
gross FFS savings, CYs 2022 through 2026, of $3,154,000,000. The
savings under the original Model are already assumed in the baseline
and therefore are not included in the 5-year gross estimated savings
under HHVBP Model expansion. As previously mentioned in section
III.A.3.b. of this proposed rule, under the expanded duration and scope
of this Model, we would continue to examine whether the proposed
adjustments to the Medicare payment amounts that would otherwise be
made to competing HHAs would result in statistically significant
improvements in the quality of care being delivered to Medicare
beneficiaries, as well as reductions in Medicare spending.
3. HH QRP
Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data in
accordance with the requirements of the HH QRP and requires HHAs to
submit data for purposes of measuring health care quality, and links
the quality data submission to the annual applicable percentage
increase.
4. Effects of the Changes to the Home Health CoPs
a. Virtual Supervision of HHA Aides
In section IV.D. of this rule, we propose to revise the CoPs for
home health agencies. Specifically, in section IV.D. of this rule, we
propose to revise the home health aide supervision requirements to
allow for virtual supervision. The burden may be reduced for providers
by improving the efficiency of the training and supervision of home
health aides. We are also adding the requirement that the skills
related to any deficient skills be addressed. We believe the burden
associated with addressing skills related to those identified as
deficient skills is minimal. Moreover, supervising employees to ensure
the safe and effective provision of patient care is standard business
practice throughout the health care community. Likewise, documenting
that this supervision has occurred for internal personnel,
accreditation, and State and Federal compliance purposes constitutes a
usual and customary business practice. Therefore, the regulatory impact
is negligible.
b. Permitting Occupational Therapists To Conduct the Initial Assessment
Visit and Complete the Comprehensive Assessment for Home Health
Agencies Under the Medicare Program
In accordance with Division CC, section 115 of CAA 2021, we are
proposing conforming regulations text changes to permit the
occupational therapist to complete the initial and comprehensive
assessments for Medicare patients when ordered with another
rehabilitation therapy service (speech language pathology or physical
therapy) that establishes program eligibility, in the case where
skilled nursing services are also not ordered. We do not expect any
increase in burden for any of these modifications. In fact, for home
health agencies, burden may be reduced by expanding the type of therapy
discipline able to complete the initial and comprehensive assessments,
in some circumstances, for Medicare patients. We do not expect the
changes for these provisions will cause any appreciable amount of
expense or anticipated saving and we do not believe this standard would
impose any additional regulatory burden.
5. Medicare Coverage of Home Infusion Therapy
Section 1834(u)(1) of the Act, as added by section 5012 of the 21st
Century Cures Act, requires the Secretary to establish a home infusion
therapy services payment system under Medicare. This payment system
requires a single payment to be made to a qualified home infusion
therapy supplier for items and services furnished by a qualified home
infusion therapy supplier in coordination with the furnishing of home
infusion drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit
of single payment is for each infusion drug administration calendar day
in the individual's home. The Secretary shall, as appropriate,
establish single payment amounts for types of infusion therapy,
including to take into account variation in utilization of nursing
services by therapy type. Section 1834(u)(1)(A)(iii) of the Act
provides a limitation to the single payment amount, requiring that it
shall not exceed the amount determined under the Physician Fee Schedule
(under section 1848 of the Act) for infusion therapy services furnished
in a calendar day if furnished in a physician office setting, except
such single payment shall not reflect more than 5 hours of infusion for
a particular therapy in a calendar day. Section 1834(u)(1)(B)(i) of the
Act requires that the single payment amount be adjusted by a geographic
wage index. Finally, section 1834(u)(1)(C) of the Act allows for
discretionary adjustments which may include outlier payments and other
factors as deemed appropriate by the Secretary, and are required to be
made in a budget neutral manner. Section 1834(u)(3) of the Act
specifies that annual updates to the single payment are required to be
made beginning January 1, 2022, by increasing the single payment amount
by the percentage increase in the CPI-U for all urban consumers for the
12-month period ending with June of the preceding year, reduced by the
productivity adjustment. The unit of single payment for each infusion
drug administration calendar day, including the required adjustments
and the annual update, cannot exceed the amount determined under the
fee schedule under section 1848 of the Act for infusion therapy
services if furnished in a physician's office, and the single payment
amount cannot reflect more than 5 hours of infusion for a particular
therapy per calendar day. Finally, Division N, section 101 of CAA 2021
amended section 1848(t)(1) of the Act and modified the CY 2021 PFS
rates by providing a 3.75 percent increase in PFS payments only for CY
2021.
6. Medicare Provider and Supplier Enrollment Provisions
Our proposals concerning Medicare provider and supplier enrollment
are needed to (1) incorporate various subregulatory policies into 42
CFR part 424, subpart P, and (2) clarify several policy issues. We
believe these proposals would increase transparency by allowing the
provider community to furnish public comments on them while eliminating
uncertainty regarding the scope and applicability of the provisions in
question.
[[Page 35991]]
7. Survey and Enforcement Requirements for Hospice Providers
In accordance with section 407 of the CAA 2021, we propose
conforming regulations which establish new hospice program survey and
enforcement requirements. We believe these proposals not only meet the
statutory requirements but would increase public transparency by
encouraging a consistent survey and enforcement process and providing
the public with information necessary to make an informed decision
regarding where they seek high quality, safe care hospice program
organizations for themselves or loved ones.
B. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
Executive Order 13132 on Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C. 801(a)(1)(B)(i)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. Therefore, we estimate
that this rule is ``economically significant'' as measured by the $100
million threshold, and hence also a major rule under the Congressional
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis
that presents our best estimate of the costs and benefits of this rule.
The following summary provides the economic impact estimates
associated with the provisions of this proposed rule:
1. Overall Impacts--HH PPS
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). The net transfer impact related to the changes in payments under
the HH PPS for CY 2022 is estimated to be $310 million (1.7 percent).
2. Overall Impacts--Home Health Value Based Purchasing Model Expansion
Beginning in CY 2024 and in each succeeding payment year under the
expanded HHVBP Model, we would adjust the final claim payment amount
for a home health agency for a date of service in the calendar year by
an amount up to the maximum applicable percent. For purposes of this
proposed rule, we have limited our analysis of the economic impacts to
the value-based incentive payment adjustments. Under the expanded Model
design, the incentive payment adjustments would be limited to the total
payment reductions to home health agencies included in the expanded
Model, such that in aggregate, payment reductions to lower-performing
HHAs would approximate the aggregate payment increases to higher-
performing HHAs. Overall, the impact of this rule is estimated at
$3,154,000,000 for CYs 2022 to 2026, though these savings result
primarily from reductions in utilization of services, including acute
hospital admissions and skilled nursing facility (SNF) visits. The
expanded Model would test the effect on quality and costs of care by
applying payment adjustments based on HHAs' performance on quality
measures.
C. Detailed Economic Analysis
1. HH PPS
This rule proposes updates to Medicare payments under the HH PPS
for CY 2022. The impact analysis of this proposed rule presents the
estimated expenditure effects of policy changes proposed in this rule.
We use the latest data and best analysis available, but we do not make
adjustments for future changes in such variables as number of visits or
case mix. This analysis incorporates the latest estimates of growth in
service use and payments under the Medicare home health benefit, based
primarily on Medicare claims data for periods ending on or before
December 31, 2020. We note that certain events may combine to limit the
scope or accuracy of our impact analysis, because such an analysis is
future-oriented and, thus, susceptible to errors resulting from other
changes in the impact time period assessed. Some examples of such
possible events are newly-legislated general Medicare program funding
changes made by the Congress, or changes specifically related to HHAs.
In addition, changes to the Medicare program may continue to be made as
a result of the Affordable Care Act, or new statutory provisions.
Although these changes may not be specific to the HH PPS, the nature of
the Medicare program is such that the changes may interact, and the
complexity of the interaction of these changes could make it difficult
to predict accurately the full scope of the impact upon HHAs.
Table 38 represents how HHA revenues are likely to be affected by
the policy changes proposed in this rule for CY 2022. For this
analysis, we used an analytic file with linked CY 2020 OASIS
assessments and home health claims data for dates of service that ended
on or before December 31, 2020. The first column of Table 38 classifies
HHAs according to a number of characteristics including provider type,
geographic region, and urban and rural locations. The second column
shows the number of facilities in the impact analysis. The third column
shows the payment effects of the Case-Mix Weights Recalibration
Neutrality Factor.
The fourth column shows the payment effects of updating to the CY
2022 wage index. The fifth column shows the payment effects of the CY
2022 rural add-on payment provision in statute. The sixth column shows
the payment effects of the proposed CY 2022 home health payment update
percentage and the last column shows the combined effects of all the
proposals in this rule.
Overall, it is projected that aggregate payments in CY 2022 would
increase by 1.7 percent. As illustrated in Table 38, the combined
effects of all of the changes vary by specific types of providers and
by location. We note that some individual HHAs within the same group
may experience different impacts on payments than others due to the
distributional impact of the CY 2022 wage index, the percentage of
total HH PPS payments that were subject to the
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LUPA or paid as outlier payments, and the degree of Medicare
utilization.
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2. Impacts for the Expanded HHVBP Model
Based on proposals discussed in section III.A. of this proposed
rule, Tables G6 and G7 display our analysis of the distribution of
possible payment adjustments using 2019 data as the performance year,
while Table 39 provides information on the estimated impact of this
proposed expansion. We note that this impact analysis is based on the
aggregate value of savings associated with all Medicare-certified HHAs
in each State, territory, and the District of Columbia.
Value-based incentive payment adjustments for the estimated 7,500-
plus HHAs that would qualify to compete in the proposed HHVBP Model
expansion based on the CY 2019 data stratified by size, as defined in
section III.F. of this proposed rule. For example, Table 40 shows
California has 69 HHAs that do not provide services to enough
beneficiaries to be required to complete HHCAHPS surveys, and
therefore, would be considered to be in the smaller-volume cohort under
the proposed Model expansion. Using 2019 performance year data and the
proposed payment adjustment of 5-percent, based on 8 outcome measures,
the 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.
The next columns provide the distribution of scores by percentile.
We see that the value-based incentive percentage payments for smaller-
volume home health agencies in California range from -3.139 percent at
the 10th percentile to +3.899 percent at the 90th percentile, while the
value-based incentive payment at the 50th percentile is -0.607 percent.
The smaller-volume HHA cohort table identifies that some locations
do not have any qualifying HHAs in the smaller-volume cohort, including
Connecticut, the District of Columbia, and Delaware.
Table 41 provides the payment adjustment distribution based on
proportion of dual eligible beneficiaries, average case mix (using HCC
scores), proportion that reside in rural areas, as well as HHA
organizational status. To define cutoffs for the ``percentage of dual
eligible beneficiaries,'' low, medium, or high percentage 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.
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BILLING CODE 4120-01-C
3. Impacts for the HH QRP for CY 2022
Estimated impacts for the HH QRP are based on analysis discussed in
section X.B. of this proposed rule. The proposed HH QRP requirements
would reduce burden to the active collection under OMB control number
#0938-1279 (CMS-10545; expiration 12/31/21).
Failure to submit data required under section 1895(b)(3)(B)(v) of
the Act with respect to a calendar year will result in the reduction of
the annual home health market basket percentage increase otherwise
applicable to an HHA or that calendar year by 2 percentage points. For
the CY 2021, 527 of the 11,196 active Medicare-certified HHAs, or
approximately 4.7 percent, did not receive the full annual percentage
increase (the methodology accommodated the COVID-19 PHE exception).
These 527 HHAs represented $253 million in home health claims payment
dollars during the reporting period compared out of a total $16.7B for
all HHAs.
As discussed in section IV.C. of this proposed rule, we are
proposing to remove one OASIS-based measure beginning with the CY 2023
HH QRP. The assessment-based measure we are proposing to remove is: (1)
Drug Education on All Medications Provided to Patient/Caregiver during
All Episodes of Care. We are also proposing to replace the Acute Care
Hospitalization During the First 60 Days of Home Health (NQF #0171)
measure and Emergency Department Use Without Hospitalization During the
First 60 Days
[[Page 35997]]
of Home Health (NQF #0173) measure with the Home Health Within Stay
Potentially Preventable Hospitalization measure beginning with the CY
2023 HH QRP under our measure removal Factor 6: A measure that is more
strongly associated with desired patient outcomes for the particular
topic is available. Because these three measures are claims-based,
there will be no impact to our collection of information.
Section X.B. of this proposed rule provides a detailed description
of the net decrease in burden associated with these proposed changes.
The associated burden is for CY 2023 because HHAs will be able to
submit data beginning CY 2023. The cost impact related to OASIS item
collection as a result of the changes to the HH QRP is estimated to be
a net decrease of $2,762,277 in annualized cost to HHAs, discounted at
7 percent relative to year 2020, over a perpetual time horizon
beginning in CY 2023.
We describe the estimated burden and cost reductions for these
measures in section X.B of this rule.
In summary, the proposed HH QRP measure removals would result in a
burden reduction of $242 per HHA annually, or $2,762,277 for all HHAs
annually. We have described the burden costs savings in Table 42:
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4. Changes to the Home Health CoPs
a. Virtual Supervision of HHA Aides
In section IV.D. of this rule, we propose to revise the CoPs for
home health agencies. Specifically, in section IV.D. of this rule, we
propose to revise the home health aide supervision requirements to
allow for virtual supervision. The burden may be reduced for providers
by improving the efficiency of the training and supervision of home
health aides. We are also adding the requirement that the skills
related to any deficient skills be addressed. We believe the burden
associated with addressing skills related to those identified as
deficient skills is minimal. Moreover, supervising employees to ensure
the safe and effective provision of patient care is standard business
practice throughout the health care community. Likewise, documenting
that this supervision has occurred for internal personnel,
accreditation, and State and Federal compliance purposes constitutes a
usual and customary business practice. Therefore, the regulatory impact
is negligible.
b. Permitting Occupational Therapists To Conduct the Initial Assessment
Visit and Complete the Comprehensive Assessment for Home Health
Agencies Under the Medicare Program
In accordance with Division CC, section 115 of CAA 2021, we are
proposing conforming regulations text changes to permit the
occupational therapist to complete the initial and comprehensive
assessments for Medicare patients when ordered with another
rehabilitation therapy service (speech language pathology or physical
therapy) that establishes program eligibility, in the case where
skilled nursing services are also not ordered. We do not expect any
increase in burden for any of these modifications. In fact, for home
health agencies, burden may be reduced by expanding the type of therapy
discipline able to complete the initial and comprehensive assessments,
in some circumstances, for Medicare patients. We do not expect the
changes for these provisions will cause any appreciable amount of
expense or anticipated saving and we do not believe this standard would
impose any additional regulatory burden.
5. Payment for Home Infusion Therapy Services
There are two new proposals in this rule related to payments for
home infusion therapy services in CY 2022: The proposal to maintain the
CY 2021 percentages for the initial subsequent policy and the proposal
to wage adjust HIT service payments using the CY 2022 GAFs Adjustments
to the home infusion therapy payment rates will be made when the CY
2022 final GAF values become available and will be budget neutral using
the GAF standardization factor. The CY 2021 home infusion therapy
service payments will also be updated by the CPI-U reduced by the
productivity adjustment. The CY 2022 final GAF values (and the CPI-U as
of June 2021) were not available at the time of rulemaking, therefore,
we are unable to estimate the impact of these adjustments on the CY
2022 HIT service payment amounts compared to the CY 2021 HIT service
payment amounts. We will outline the home infusion therapy payment
impacts in the CY 2022 HH PPS final rule.
6. Medicare Provider and Supplier Enrollment Provisions
a. General Impact
Similar to our position regarding information collection
requirements, and except as stated in section XI.C.6.b. of this
proposed rule, we do not anticipate any costs, savings, or transfers
associated with our provider and supplier enrollment proposals. Most of
these proposals have been in subregulatory guidance for a number of
years, and we are merely incorporating them into regulation; those
proposed provisions that are not in subregulatory guidance do not
involve any costs, savings, or transfers.
b. Deactivation of Billing Privileges--Payment Prohibition
As explained in section VI.B of this proposed rule, we are
proposing in new 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 subregulatory guidance permits the provider
or supplier to bill for services or items furnished up to 30 days prior
to the effective date of the reactivation of the provider's or
supplier's billing privileges. Our proposal would reverse this policy
for the reasons stated in section VI.B. of this proposed rule.
Although the figure varies widely by individual provider or
supplier, internal CMS data suggests that the average provider/supplier
impacted by this proposal receives roughly $50,000 in Medicare payments
each year. (We used a similar $50,000 annual payment estimate for our
provider enrollment provisions in a CMS final rule published in the
Federal Register on November 15, 2019 titled, ``CY 2020 Revisions to
Payment Policies under the Physician Fee Schedule and Other Changes to
Part B Payment Policies'') (84 FR 62568). As with annual payment
amounts, the number of deactivations vary per year. Nonetheless, and
based on internal CMS data, we estimate 13,000 deactivations annually.
This results in an approximate burden of $54,145,000 per year (13,000 x
50,000 x 0.0833). (The 0.0833 figure represents
[[Page 35998]]
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:
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7. Survey and Enforcement Requirements for Hospice Providers
Estimated impacts for the Survey and Certification Requirements for
Hospice Program Providers are based on analysis discussed in section
VII. of this proposed rule.
a. Application and Re-Application Procedures for National Accrediting
Organizations (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 seek comments that would help us to develop an accurate estimate of
the cost and time burden that would result from this collection of
information.
b. Release and Use of Accreditation Surveys (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.
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.
d. Surveyor Qualifications and Prohibition of Conflicts of Interest
(Sec. 488.1115)
We propose at Sec. 488.1115, to require AO hospice program
surveyors to complete the CMS hospice basic training currently
available online. The hospice basic training course has an average
completion time of 24 hours. Completion time could be more or less
depending upon the learner's familiarity with the content and overall
learning style. We are not able to estimate precisely total time and
cost burden to each AO for the wages incurred for the time spent by all
surveyors from each of the three hospice program AOs to take the CMS
online surveyor training course, because each AO varies greatly in
organization size, number of accreditation programs approved by CMS,
and total surveyor cadre numbers. There are no regulatory requirements
for AOs to report to CMS on the number of surveyors within their
organization nor information on how many of those surveyors survey each
type of program approved by CMS. CMS notes there is a wide variety of
total surveyor cadre numbers across all three AOs, based on information
CMS has gathered from confidential numbers, voluntarily provided by
some of the AOs to CMS, as part of their deeming authority application
documents as well as information found online via a search of each AOs
public website. Variation is generally based on the associated number
of CMS-approved accreditation programs the AO possesses. For example,
AOs who accredit only one provider or supplier type generally have
about 25 surveyors while AOs with multiple programs have surveyor
numbers well over 300 thereby skewing the ability to estimate an
accurate time burden that represents the overall group. Because of this
wide range CMS is estimating near the middle, using the range of 100
total surveyors per AO. If we estimate that each AO has approximately
100 total surveyors, the estimated time burden to each AO associated
with this requirement would be 2,400 hours (24 hours x 100 surveyors).
The estimated cost burden to each AO with CMS-approved hospice
programs associated with this requirement would be $184,656 (2,400
hours x $76.94 per hour (based on the salary of a registered nurse. See
Table 37)).
As of March 2021, there are three AOs that accredit Medicare-
certified hospice programs. We estimate that the time burden across all
of these AOs associated with the requirement that their surveyors take
the CMS online surveyor training would be 7,200 hours (2,400 hours x 3
AOs). The estimated cost across all AOs (that accredit Medicare-
certified hospice programs) would be $553,968 ($184,656 x 3 AOs). We
also proposed to set out the circumstances that will disqualify a
surveyor from surveying a particular hospice in accordance with new
section 1822(a)(4)(B) of the Act). We do not expect these proposed
changes will cause any appreciable amount of expense or anticipated
saving because the provisions codify longstanding policies and basic
principles to ensure there is no conflict of interest between
organizations and surveyors.
e. Survey Teams (Sec. 488.1120)
We propose 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.
[[Page 35999]]
The proposed inclusion of multidisciplinary survey team members could
potentially increase the overall cost of surveys if SA and AOs were not
already using a mixed team.
The 2020 Bureau of Labor Statistics estimates RN adjusted hourly
wages at $76.94 (including fringe benefits and overhead). Other
potential disciplines fall below and above the RN adjusted hourly wage,
for example: Social workers--$50.12 per hour, pharmacists--$120.64 per
hour, and psychologists--$108.36 per hour. A survey team of all nurses
(assuming a two-person team) costs $153.88 ($76.94 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 + $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 seek comments on the current professional makeup of the AO
and SA survey teams, and providers' estimates of the time needed to
effectuate multidisciplinary teams where they do not currently exist.
f. Consistency of Survey Results (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.
g. Special Focus Program (Sec. 488.1130)
There may be an additional SA burden in terms of the need for
enhanced survey and enforcement activities which is in part why a more
methodical and targeted approach to the implementation of this program
should be considered given the allocation of $10 million to support
this and the other provisions that would not begin until FY 2022.
h. Enforcement Remedies (Sec. Sec. 488.1200 Through Sec. 488.1265)
We propose enforcement remedies for hospices consistent with the
established alternative sanctions for HHAs. In CY 2019, out of 11,738
deemed and 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. This data was
examined using the survey data for the CY 2019 in the CMS QCOR system.
Of the total number of CMS-certified hospices, 4,399 received an
unannounced standard and/or complaint survey and 236 were cited for
noncompliance with one or more condition-level deficiencies. Therefore,
approximately 5 percent of the total hospices surveyed had the
potential to receive an enforcement remedy based on noncompliance with
one or more CoPs.
The enforcement remedy provisions in this proposed rule mirror the
alternative sanctions used in HHAs that have already been incorporated
into CMS policy. Therefore, in terms of the administrative expenses to
design and manage these types of remedies, the infrastructure is
already in place. In terms of training for Federal and State surveyors,
it is common for surveyors that survey HHAs to be cross-trained to
survey hospices. Since the enforcement remedies for hospice are similar
to those for HHAs, we expect that there will be a minimal burden on
seasoned surveyors to become familiar with these provisions.
Additionally, the data analysis described previously for hospices in CY
2019 reflects the probability of a low impact for civil monetary
penalties to be imposed on hospice providers.
8. Certain Compliance Date Changes for the IRF QRP and LTCH QRP
a. Impacts for the Inpatient Rehabilitation Facility Quality Reporting
Program for FY 2023
This proposed rule would not impose any new information collection
requirements. However, this proposed rule does reference associated
information collections that are not discussed in the regulation text
contained in this document. The following is a discussion of this
information collection, which have already received OMB approval.
In accordance with section 1886(j)(7)(A) of the Act, the Secretary
must reduce by 2 percentage points the annual market basket increase
factor otherwise applicable to an IRF for a fiscal year if the IRF does
not comply with the requirements of the IRF QRP for that fiscal year.
As stated in section VIII.A. of this proposed rule for purposes of
calculating the FY 2023 Annual Increase Factor (AIF), we propose that
IRFs would begin using the IRF-PAI V4.0 to collect data on the TOH
Information to Provider-PAC and the TOH Information to Patient-PAC
measures beginning with admissions and discharges on October 1, 2022.
We also proposed that IRFs would begin to use the IRF-PAI V4.0 to
collect data on certain Standardized Patient Assessment Data Elements,
beginning with admissions and discharges (except for the hearing,
vision, race, and ethnicity Standardized Patient Assessment Data
Elements, which would be collected at admission only) on October 1,
2022.
The proposed IRF QRP requirements would add no additional burden or
cost to the active collection under OMB control number 0938-0842
(expiration 12/31/2022).
b. Impacts for the Long-Term Care Hospital Quality Reporting Program
for FY 2023
This proposed rule not impose any new information collection
requirements. However, this proposed rule does reference associated
information collections that are not discussed in the regulation text
contained in this document. The following is a discussion of this
information collection discussed later in this section, which have
already received OMB approval.
In accordance with section 1886(m)(5) of the Act, the Secretary
must reduce by 2 percentage points the annual market basket payment
update otherwise applicable to a LTCH for a fiscal year if the LTCH
does not comply with the requirements of the LTCH QRP for that fiscal
year. As stated in section VIII.B. of this proposed rule for purposes
of calculating the FY 2023 Annual Payment Update (APU), we propose that
LTCHs would begin using the LTCH Continuity Assessment Record and
Evaluation (CARE) Data Set (LCDS) V5.0 to collect data on the TOH
Information to Provider-PAC and the TOH Information to Patient-PAC
measures beginning with admissions and discharges on October 1, 2022.
We also
[[Page 36000]]
proposed that LTCHs would begin to use the LTCH LCDS V5.0 to collect
data on certain Standardized Patient Assessment Data Elements,
beginning with admissions and discharges (except for the hearing,
vision, race, and ethnicity Standardized Patient Assessment Data
Elements, which would be collected at admission only) on October 1,
2022.
The proposed LTCH QRP requirements would add no additional burden
or cost to the active collection under OMB control number 0938-1163
(expiration 12/31/2022).
D. Limitations of Our Analysis
Our estimates of the effects of this proposed rule are subject to
significant uncertainty. It is difficult to estimate the burden and
savings from the proposed changes because they depend on several
factors previously described. We appreciate that our assumptions are
simplified and that actual results could be considerably higher or
lower. Although there is uncertainty concerning the magnitude of all of
our estimates, we do not have the data to provide specific estimates
for each proposal, as to the range of possibilities, or to estimate all
categories of possible benefits. We seek comments on all aspects of
this analysis.
E. Regulatory Review Cost Estimation
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this proposed rule, we
must estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that would review the rule, we assume that the total number of unique
reviewers of this year's proposed rule would be the similar to the
number of commenters on last year's proposed rule. We acknowledge that
this assumption may understate or overstate the costs of reviewing this
rule. It is possible that not all commenters reviewed this year's rule
in detail, and it is also possible that some reviewers chose not to
comment on the proposed rule. For these reasons we believe that the
number of past commenters would be a fair estimate of the number of
reviewers of this rule. We welcome any comments on the approach in
estimating the number of entities which would review this proposed
rule. We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this proposed rule,
and therefore for the purposes of our estimate we assume that each
reviewer reads approximately 50 percent of the rule. We seek comments
on this assumption.
Using the wage information from the BLS for medical and health
service managers (Code 11-9111), we estimate that the cost of reviewing
this rule is $114.24 per hour, including overhead and fringe benefits
https://www.bls.gov/oes/current/oes_nat.htm. This proposed rule
consists of approximately 121,000 words. Assuming an average reading
speed of 250 words per minute, we estimate that it would take
approximately 4.03 hours for the staff to review half of this rule. For
each entity that reviews the rule (we estimate that there are 165
reviewers), the estimated cost is $574 (4.03 hours x $114.24).
Therefore, we estimate that the total cost of reviewing this proposed
rule is $75,964.35 ($460.39 x 165 reviewers).
F. Alternatives Considered
1. Alternatives Considered to the HH PPS Policy Proposals
For the CY 2022 HH PPS proposed rule, we considered alternatives to
the proposals articulated in section II. of this proposed rule. We
considered using CY 2019 data for ratesetting. However, our analysis
showed there were only small differences in the payment rates and
impacts in the aggregate when using CY 2019 data compared to CY 2020
data. These differences in payment rates reflect small differences in
the wage index budget neutrality factors calculated using CY 2020 data
compared to using CY 2019 claims data. We note, we would not have
recalibrated the case-mix weights using CY 2019 data because CY 2019
data would use simulated 30-day periods from 60-episodes as CY 2020 is
the first year of actual PDGM data. Therefore, no case-mix weight
budget neutrality factor using CY 2019 utilization data would be
applied. We believe it is best to continue with our established policy
of using the most recent, complete data at the time of rulemaking for
CY 2022 ratesetting, which would be CY 2020 claims data. Additionally,
we considered alternatives to our case-mix recalibration proposal.
These alternatives included an option do a full recalibration of the
case-mix weights, including the functional impairment levels,
comorbidity subgroups as proposed, but also updating the LUPA
thresholds, as well as an option to not recalibrate the case-mix
weights, functional impairment levels, comorbidity subgroups and LUPA
thresholds. However, we believe that recalibrating the PDGM case-mix
weights, functional levels, and comorbidity adjustment subgroups while
maintaining the LUPA thresholds for CY 2022 would more accurately
adjust home health payments because the data would reflect 30-day
periods under the new PDGM system based on actual data rather than data
that simulated 30-day episodes under the old system. The recalibrated
case-mix weights would also more accurately reflect the types of
patients currently receiving home health services while mitigating
instability by maintaining the LUPA thresholds. As stated previously
the LUPA thresholds are based on the number of overall visits in a
particular case-mix group (the threshold is the 10th percentile of
visits or 2 visits, whichever is greater) instead of a relative value
(as is used to generate the case-mix weight) that would control for the
impacts of the PHE. We note that visit patterns and some of the
decrease in overall visits in CY 2020 may not be representative of
visit patterns in CY 2022. Also, our analysis shows that there is more
variation in the case-mix weights with the full recalibration
(including updates to the LUPA thresholds) than the recalibration with
the case-mix weights maintained. Maintaining the LUPA thresholds
creates more stability in the weights. The recalibrated case-mix
weights using the current LUPA thresholds are more similar to the CY
2020 weights than the recalibrated case-mix weights with the updated
LUPA thresholds. For these reasons, we believe it is best to maintain
the LUPA thresholds for CY 2022 instead of the alternative full
recalibration including updates to the LUPA thresholds.
2. Alternatives Considered to the HHVBP Policy Proposals
We considered alternatives to the proposed policies in sections
III.A. and III.B. of this proposed rule. Specifically, we considered
not expanding the HHVBP Model at this point in time, and waiting until
we have final evaluation results from the original HHVBP Model before
pursuing a national expansion. However, we considered that we have
evaluation results from multiple years of the original HHVBP Model,
showing significant reductions in spending and improvements in quality.
We believe this evidence is sufficient for a national expansion of the
Model, and note that we will continue to review evaluation results as
they come in for the later years of the original HHVBP Model.
For the expanded HHVBP Model, we also considered utilizing the same
state- and volume-based cohorts as the original HHVBP Model in lieu of
the national volume-based cohorts we are proposing. However, this
approach
[[Page 36001]]
could require grouping together of certain States, territories, and the
District of Columbia that have an insufficient number of HHAs at the
end of the performance year, based solely on their lower HHA counts.
This would also preclude providing benchmarks and achievement
thresholds prospectively. An analysis of the 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.
Using CY 2019 data to simulate the payment adjustments, the mean
payment adjustments at the State-level are within +/- 1.0 percent for
both cohort options. Relative to the 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.
For the reasons described in section III.B.2. of this proposed
rule, we are proposing to not apply any payment adjustments for CY 2022
of the original HHVBP Model based on data reported in CY 2020 and to
instead end the original Model early, with the CY 2021 payment
adjustment year. As previously noted, we will continue to examine data
for CY 2020 as it becomes available in order to determine whether it
would be appropriate to utilize such data for CY 2022 payment
adjustments, in accordance with current Model policies.
3. Alternatives Considered Concerning Deactivation Payment Prohibition
As discussed in section VI.B. of this proposed rule, we are
proposing in new 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 this proposed rule, 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.
G. Accounting Statement and Tables
1. HH PPS
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 43, we have prepared an accounting statement showing
the classification of the transfers and benefits associated with the CY
2022 HH PPS provisions of this rule.
[GRAPHIC] [TIFF OMITTED] TP07JY21.065
2. HHVBP Model Expansion
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 44, we have prepared an accounting statement showing
the classification of the expenditures associated with this proposed
rule as they relate to hospitals and SNFs. Table 44 provides our best
estimate of the decrease in Medicare payments under the proposed
expanded HHVBP Model.
[GRAPHIC] [TIFF OMITTED] TP07JY21.066
3. HHQRP
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 45, we have prepared an accounting statement showing
the classification of the expenditures associated with this proposed
rule as they relate to HHAs. Table 45 provides our best estimate of the
decrease in Medicare payments.
[[Page 36002]]
[GRAPHIC] [TIFF OMITTED] TP07JY21.067
H. Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. In addition, HHAs and home infusion therapy
suppliers are small entities, as that is the term used in the RFA.
Individuals and States are not included in the definition of a small
entity.
The North American Industry Classification System (NAICS) was
adopted in 1997 and is the current standard used by the Federal
statistical agencies related to the U.S. business economy. We utilized
the NAICS U.S. industry title ``Home Health Care Services'' and
corresponding NAICS code 621610 in determining impacts for small
entities. The NAICS code 621610 has a size standard of $16.5 million
\143\ and approximately 96 percent of HHAs and home infusion therapy
suppliers are considered small entities. Table 46 shows the number of
firms, revenue, and estimated impact per home health care service
category.
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[GRAPHIC] [TIFF OMITTED] TP07JY21.068
The economic impact assessment is based on estimated Medicare
payments (revenues) and HHS's practice in interpreting the RFA is to
consider effects economically ``significant'' only if greater than 5
percent of providers reach a threshold of 3 to 5 percent or more of
total revenue or total costs. The majority of HHAs' visits are Medicare
paid visits and therefore the majority of HHAs' revenue consists of
Medicare payments. Based on our analysis, we conclude that the policies
proposed in this rule would not result in an estimated total impact of
3 to 5 percent or more on Medicare revenue for greater than 5 percent
of HHAs. We note also, and as discussed in section XI.C.6. of this
proposed rule, our proposal to prohibit payments for services and items
furnished by deactivated providers and suppliers would affect only a
very limited number of Medicare providers and suppliers. Therefore, the
Secretary has determined that this HH PPS proposed rule would not have
significant economic impact on a substantial number of small entities.
Guidance issued by the Department of Health and Human Services
interpreting the Regulatory Flexibility Act considers the effects
economically `significant' only if greater than 5 percent of providers
reach a threshold of 3- to 5-percent or more of total revenue or total
costs. Among the over 7,500 HHAs that are estimated to qualify to
compete in the expanded HHVBP Model, we estimate that the percent
payment adjustment resulting from this rule would be larger than 3
percent, in magnitude, for about 28 percent of competing HHAs
(estimated by applying the proposed 5-percent maximum payment
adjustment under the expanded Model to CY 2019 data). As a result, more
than the RFA threshold of 5-percent of HHA providers nationally would
be significantly impacted. We refer readers to Tables G6 and G7 of this
proposed rule for our analysis of
[[Page 36003]]
payment adjustment distributions by State, HHA characteristics, HHA
size and percentiles.
Thus, the Secretary has determined that this proposed rule would
have a significant economic impact on a substantial number of small
entities. Though the RFA requires consideration of alternatives to
avoid economic impacts on small entities, the intent of the rule,
itself, is to encourage quality improvement by HHAs through the use of
economic incentives. As a result, alternatives to mitigate the payment
reductions would be contrary to the intent of the rule, which is to
test the effect on quality and costs of care of applying payment
adjustments based on HHAs' performance on quality measures.
I. Unfunded Mandates Reform Act (UMRA)
Section 202 of UMRA of 1995 UMRA also requires that agencies assess
anticipated costs and benefits before issuing any rule whose mandates
require spending in any 1 year of $100 million in 1995 dollars, updated
annually for inflation. In 2021, that threshold is approximately $158
million. This rule is not anticipated to have an effect on State,
local, or tribal governments, in the aggregate, or on the private
sector of $158 million or more.
J. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have reviewed this proposed rule under these criteria
of Executive Order 13132, and have determined that it will not impose
substantial direct costs on State or local governments.
K. Conclusion
In conclusion, we estimate that the provisions in this proposed
rule would result in an estimated net increase in home health payments
of 1.7 percent for CY 2022 ($310 million). The $310 million increase in
estimated payments for CY 2022 reflects the effects of the CY 2022 home
health payment update percentage of 1.8 percent ($330 million increase)
and an estimated 0.1 percent decrease in payments due to the rural add-
on percentages mandated by the Bipartisan Budget Act of 2018 for CY
2022 ($20 million decrease).
L. Executive Order 12866
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget reviewed this proposed rule.
I, Chiquita Brooks-LaSure, Administrator of the Centers for
Medicare & Medicaid Services, approved this document on June 16, 2021.
List of Subjects
42 CFR Part 409
Health facilities, Medicare.
42 CFR Part 424
Emergency medical centers, Health facilities, Health professions,
Medicare, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 484
Health facilities, Health professions, Medicare, and Reporting and
recordkeeping requirements.
42 CFR Part 488
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 489
Health facilities, Medicare Reporting and recordkeeping
requirements.
42 CFR Part 498
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as follows:
PART 409--HOSPITAL INSURANCE BENEFITS
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) subject 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
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 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.
0
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
[[Page 36004]]
the provider or supplier has met all program requirements (including
State licensure requirements), and services were provided at the
enrolled practice location for up to--
(i) Thirty days prior to their effective date if circumstances
precluded enrollment in advance of providing services to Medicare
beneficiaries; or
(ii) Ninety days prior to their effective date if a Presidentially-
declared disaster under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act) precluded
enrollment in advance of providing services to Medicare beneficiaries.
(2) The provider and supplier types to which paragraph (a) applies
are as follows:
(i) Physicians.
(ii) Non-physician practitioners.
(iii) Physician organizations.
(iv) Non-physician practitioner organizations.
(v) Ambulance suppliers.
(vi) Opioid treatment programs.
(vii) Part B hospital departments.
(viii) Clinical Laboratory Improvement Amendment labs.
(ix) Intensive cardiac rehabilitation facilities.
(x) Mammography centers.
(xi) Mass immunizers/pharmacies.
(xii) Radiation therapy centers.
(xiii) Home infusion therapy suppliers.
(xiv) Physical therapists.
(xv) Occupational therapists.
(xvi) Speech language pathologists.
* * * * *
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 paragraph (a)(1);
0
b. In paragraphs (a)(2), (a)(3), and (b) by removing the phrase
``prospective provider'' and adding the word ``provider'' each time it
appears; and
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 email when the
provider or supplier was not otherwise permitted to do so.
(ix) The provider or supplier failed to submit all of the forms
needed to process a Form CMS-855 reassignment package within 30 days of
receipt.
(x) The provider or supplier submitted the incorrect Form CMS-855
application.
* * * * *
(e) Applicability. Except as otherwise specified in the applicable
reason for rejection under paragraph (a) of this section, this section
applies to all CMS Medicare provider enrollment application
submissions, including, but not limited to, the following:
(1) Form CMS-855 initial applications, change of information
requests, changes of ownership, revalidations, and reactivations.
(2) Form CMS-588 (Electronic Funds Transfer (EFT) Authorization
Agreement) submissions.
(3) Form CMS-20134 (Medicare Enrollment Application; Medicare
Diabetes Prevention Program (MDPP) Suppliers) submissions.
(4) Any electronic or successor versions of the forms identified in
paragraphs (e)(1) through (3) of this section.
0
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 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.
[[Page 36005]]
(13) The provider or supplier submits a Form CMS-855A or Form CMS-
855B initial application followed by a Form CMS-855A or Form CMS-855B
change of ownership application. If the Medicare contractor--
(i) Has not yet made a recommendation for approval concerning the
initial application, both applications may be returned.
(ii) Has made a recommendation for approval concerning the initial
application, the Medicare contractor may return the change of ownership
application. If, per the Medicare contractor's written request, the
provider or supplier fails to submit a new initial Form CMS-855A or
Form CMS-855B application containing the new owner's information within
30 days of the date of the letter, the Medicare contractor may return
the originally submitted initial Form CMS-855A or Form CMS-855B
application.
(b) Appeals. A provider or supplier is not afforded appeal rights
if their application is returned under this section.
(c) Applicability. Except as otherwise specified in the applicable
return reason under paragraph (a) of this section, this section applies
to all CMS Medicare provider enrollment application submissions
including, but not limited to, the following:
(1) Form CMS-855 initial applications, change of information
requests, changes of ownership, revalidations, and reactivations.
(2) Form CMS-588 submissions.
(3) Form CMS-20134 submissions.
(4) Any electronic or successor versions of the forms identified in
paragraphs (c)(1) through (3) of this section.
0
9. Section 424.540 is amended--
0
a. By revising paragraph (a)(2);
0
b. By adding paragraphs (a)(4) through (8);
0
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 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.
0
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 this exception, low utilization or
no utilization cost reports do not qualify as full cost reports.
* * * * *
PART 484--HOME HEALTH SERVICES
0
11. The authority citation for part 484 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
12. 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.
* * * * *
[[Page 36006]]
0
13. Section 484.80 is amended by
0
a. Revising paragraph (h)(1)(i);
0
b. Redesignating paragraphs (h)(1)(ii) and (iii) as (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 by using two-way audio-video telecommunications
technology that allows for real-time interaction between the registered
nurse (or other appropriate skilled professional) and the patient, not
to exceed 2 virtual supervisory assessments per HHA in a 60-day period.
* * * * *
(2)(i) If home health aide services are provided to a patient who
is not receiving skilled nursing care, physical or occupational
therapy, or speech language pathology services--
(A) The registered nurse must make an onsite, in person visit every
60 days to assess the quality of care and services provided by the home
health aide and to ensure that services meet the patient's needs; and
(B) The home health aide does not need to be present during this
visit.
(ii) Semi-annually the registered nurse must make an on-site visit
to the location where a patient is receiving care in order to observe
and assess each home health aide while he or she is performing non-
skilled care.
(3) If a deficiency in aide services is verified by the registered
nurse or other appropriate skilled professional during an on-site
visit, then the agency must conduct, and the home health aide must
complete, retraining and a competency evaluation for the deficient and
all related skills.
* * * * *
Subpart F--Home Health Value-Based Purchasing (HHVBP) Models
0
14. The heading for subpart F is revised to read as set forth above.
0
15. Subpart F is amended by adding 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
16. 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
17. Section 484.315 is amended by removing paragraph (d).
0
18. Subpart F is amended by adding 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 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 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.
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
[[Page 36007]]
performance level on a measure during the baseline year.
Larger-volume cohort means the group of competing HHAs that are
participating in the HHCAHPS survey in accordance with 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 US territories, including
the District of Columbia.
Payment adjustment means the amount by which a competing HHA's
final claim payment amount under the HH PPS is changed in accordance
with the methodology described in 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.
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 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 CY 2021, and the first performance
year is the first full calendar year 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, and for a performance year, an HHA must submit all of the
following to CMS in the form and manner, and at a time, specified by
CMS:
(i) Data on measures specified under the expanded HHVBP model.
(ii) HHCAHPS Survey data. For purposes of HHCAHPS Survey data
submission, the following additional requirements apply:
(A) Survey requirements. An HHA must contract with an approved,
independent HHCAHPS survey vendor to administer the HHCAHPS survey on
its behalf.
(B) CMS approval. CMS approves an HHCAHPS survey vendor if the
applicant has been in business for a minimum of 3 years and has
conducted surveys of individuals and samples for at least 2 years.
(C) Definition of survey of individuals. For the HHCAHPS survey, a
``survey of individuals'' is defined as the collection of data from at
least 600 individuals selected by statistical sampling methods and the
data collected are used for statistical purposes.
(D) Administration of the HHCAHPS survey. No organization, firm, or
business that owns, operates, or provides staffing for an HHA is
permitted to administer its own HHCAHPS Survey or administer the survey
on behalf of any other HHA in the capacity as an HHCAHPS survey vendor.
Such organizations are not approved by CMS as HHCAHPS survey vendors.
(E) Compliance by HHCAHPS survey vendors. Approved HHCAHPS survey
vendors must fully comply with all HHCAHPS survey oversight activities,
including allowing CMS and its HHCAHPS survey team to perform site
visits at the vendors' company locations.
(F) Patient count exemption. An HHA that has less than 60 eligible
unique HHCAHPS survey patients must annually submit to CMS its total
HHCAHPS survey patient count to be exempt from the HHCAHPS survey
reporting requirements for a calendar year.
(2) [Reserved]
(b) Competing home health agencies are required to collect and
report such information as the Secretary determines is necessary for
purposes of monitoring and evaluating the expanded HHVBP Model under
section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
(c) For each performance year of the expanded HHVBP Model, CMS
publicly reports applicable measure benchmarks and achievement
thresholds for each cohort as well as all of the following for each
competing HHA that qualified for a payment adjustment for the
applicable performance year on a CMS website:
(1) The Total Performance Score.
(2) The percentile ranking of the Total Performance Score.
(3) The payment adjustment percentage.
(4) Applicable measure results and improvement thresholds.
(d) CMS may grant an exception with respect to quality data
reporting requirements in the event of extraordinary circumstances
beyond the control of the HHA. CMS may grant an exception as follows:
(1) A competing HHA that wishes to request an exception with
respect to quality data reporting requirements must submit its request
to CMS within 90 days of the date that the extraordinary circumstances
occurred. Specific requirements for submission of a request for an
exception are available on the CMS website.
(2) CMS may grant an exception to one or more HHAs that have not
requested an exception if CMS determines either of the following:
(i) That a systemic problem with CMS data collection systems
directly affected the ability of the HHA to submit data.
(ii) That an extraordinary circumstance has affected an entire
region or locale.
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
[[Page 36008]]
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 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 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).
(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.
[[Page 36009]]
(4) Scope of review for reconsideration. In conducting the
reconsideration review, CMS reviews the applicable measures and
performance scores, the evidence and findings upon which the
determination was based, and any additional documentary evidence
submitted by the HHA. CMS may also review any other evidence it
believes to be relevant to the reconsideration. The HHA must prove its
case by a preponderance of the evidence with respect to issues of fact.
(5) Reconsideration decision. CMS reconsideration officials issue a
written final determination.
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
0
19. The authority citation for part 488 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
20. 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.
* * * * *
0
21. 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.
* * * * *
(a) * * *
(4) * * *
(x) For accrediting organizations applying for approval or re-
approval of CMS-approved hospice programs, a statement acknowledging
that the AO will include a statement of deficiencies (that is, the Form
CMS-2567 or a successor form) to document findings of the hospice
Medicare conditions of participation in accordance with section
1822(a)(2)(A)(ii) of the Act and will submit such in a manner specified
by CMS.
* * * * *
0
22. Section 488.7 is amended by revising paragraph (b) by 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 accreditation organization conducted on or after October 1,
2022, for hospice programs, including copies of a hospice program's
survey deficiencies, and enforcement actions (for example, involuntary
terminations) taken as a result of such surveys, on its public website
in a manner that is prominent, easily accessible, readily
understandable, and searchable for the general public and allows for
timely updates.
0
23. 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
24. Add subparts M and N to read as follows:
Subpart M--Survey and Certification of Hospice Programs
Sec.
488.1100 Basis and scope.
488.1105 Definitions.
488.1110 Hospice program: surveys and hotline.
488.1115 Surveyor qualifications and prohibition of conflicts of
interest.
488.1120 Survey teams.
488.1125 Consistency of survey results.
488.1130 Special focus program.
Subpart N--Enforcement Remedies for Hospice Programs with Deficiencies
Sec.
488.1200 Statutory basis.
488.1205 Definitions.
488.1210 General provisions.
488.1215 Factors to be considered in selecting remedies.
488.1220 Available remedies.
488.1225 Action when deficiencies pose immediate jeopardy.
488.1230 Action when deficiencies are at the condition-level but do
not pose immediate jeopardy.
488.1235 Temporary management.
488.1240 Suspension of all or part of the payments.
488.1245 Civil money penalties.
488.1250 Directed plan of correction.
488.1255 Directed in-service training.
488.1260 Continuation of payments to a hospice program with
deficiencies.
488.1265 Termination of provider agreement.
Subpart M--Survey and Certification of Hospice Programs
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
[[Page 36010]]
(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 Course, and additional
training as specified by CMS.
(b) Disqualifications. Any of the following circumstances
disqualifies a surveyor from surveying a particular hospice program:
(1) The surveyor currently serves, or, within the previous 2 years
has served, with the hospice program to be surveyed as one of the
following:
(i) A direct employee.
(ii) An employment agency staff at the hospice program.
(iii) An officer, consultant, or agent for the hospice program to
be surveyed concerning compliance with conditions of participation
specified in or in accordance with sections 1861(dd) of the Act.
(2) The surveyor has a financial interest or an ownership interest
in the hospice program to be surveyed.
(3) The surveyor has an immediate family member, as defined at.
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.
Sec. 488.1130 Special focus program.
(a) In general.--The Secretary must conduct a special focus program
for the enforcement of conditions of participation for hospice programs
that the Secretary has identified as having substantially failed to
meet applicable requirements for Medicare participation.
(b) Criteria for inclusion in the hospice special focus program.
(1) A hospice program may be required to participate in a special focus
program if any one of the following criteria exists:
(i) The hospice program is found to be deficient with condition-
level findings during two consecutive standard surveys.
(ii) The hospice program is found to be deficient with condition-
level findings during two consecutive complaint surveys.
(iii) The hospice program is found to be deficient with two or more
condition-level findings during a validation survey.
(2) CMS provides the State survey agencies with a list of hospice
programs identified as meeting the criteria for inclusion in the
special focus program. A program that meets the criteria will be placed
on the special focus program candidate list and selected for the
program as specified by CMS.
(c) Periodic surveys. The State Survey Agency, on CMS's behalf,
conducts an onsite survey of each hospice in the program not less than
once every 6 months to examine all the Medicare hospice program
conditions of participation and recommend progressive enforcement in
accordance with an enforcement remedy or remedies until the hospice
program either of the following:
(1) Graduates from the special focus program by coming back into
full compliance with the hospice conditions of participation on two
consecutive 6-month surveys.
(2) Is terminated from the Medicare or Medicaid or both programs.
Subpart N--Enforcement Remedies for Hospice Programs with
Deficiencies
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/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
[[Page 36011]]
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 of this part for each condition-level
deficiency constituting noncompliance.
(d) Plan of correction requirement. Regardless of which remedy is
applied, a non-compliant hospice program must submit a plan of
correction for approval by CMS or the State Survey Agency.
(e) Notification requirements--(1) Notice of intent. CMS provides
written notification to the hospice program of the intent to impose the
remedy, the statutory basis for the remedy, the nature of the
noncompliance, the proposed effective date of the sanction, and the
appeal rights. For payment suspensions, the notice of intent would also
identify which payments are being suspended, and for civil money
penalties, the notice of intent would also include the amount being
imposed.
(2) Final notice. With respect to civil money penalties, CMS
provides a written final notice to the hospice program, as set forth in
Sec. 488.1245(e), once the administrative determination is final.
(3) Date of enforcement action. The notice periods specified in
Sec. 488.1225(b) and Sec. 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.
(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, for a period not to exceed 6 months:
(a) Civil money penalties.
(b) Suspension of payment for all or part of the payments.
(c) Temporary management of the hospice program.
(d) Directed plan of correction.
(e) Directed in-service training.
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-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. 488.1225(e).
(c) Transfer of care. A hospice program, if its provider agreement
is terminated, is responsible for providing information, assistance,
and arrangements necessary for the proper and safe transfer of patients
to another local hospice program within 30 calendar days of
termination.
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-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. (1) CMS may impose temporary management of a
hospice program if it determines that a hospice program has a
condition-level deficiency and CMS determines that management
limitations or the
[[Page 36012]]
deficiencies are likely to impair the hospice program's ability to
correct the noncompliance and return the hospice program to compliance
with all of the conditions of participation within the timeframe
required.
(b) Procedures--(1) Notice of intent. Before imposing this remedy,
CMS notifies the hospice program in accordance with 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 all or part of the payments.
(a) Application. (1) CMS may suspend all or part of the payments to
which a hospice program would otherwise be entitled with respect to
items and services furnished by a hospice program on or after the date
on which the Secretary determines that remedies should be imposed.
(2) CMS considers this remedy for any deficiency related to poor
patient care outcomes, regardless of whether the deficiency poses
immediate jeopardy.
(b) Procedures--(1) Notice of intent. (i) Before suspending
payments, CMS provides the hospice program notice of the suspension of
payment in accordance with 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) Suspension of payment remedy may be imposed
anytime a hospice program is found to be out of substantial compliance
with the conditions of participation.
(ii) Suspension of payment remains in place until CMS determines
that the hospice program has achieved substantial compliance with the
conditions of participation or is terminated, as determined by CMS.
(3) Resumption of payments. Payments to the hospice program resume
prospectively on the date that CMS determines that the hospice program
has achieved substantial compliance with the conditions of
participation.
(c) Duration and effect of remedy. This remedy ends when any of the
following occur:
(1) CMS determines that the hospice program has achieved
substantial compliance with all of the conditions of participation.
(2) When the hospice program is terminated or CMS determines that
the hospice program is not in compliance with the conditions of
participation at a maximum of 6 months from the date of the survey
identifying the noncompliance.
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 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
[[Page 36013]]
immediate jeopardy. The penalty in this range continues until
substantial compliance can be determined based on a revisit survey.
(i) $10,000, as adjusted annually under 45 CFR part 102, per day
for a deficiency or deficiencies that are immediate jeopardy and that
result in actual harm.
(ii) $9,000, as adjusted annually under 45 CFR part 102, per day
for a deficiency or deficiencies that are immediate jeopardy and that
result in a potential for harm.
(iii) $8,500, as adjusted annually under 45 CFR part 102, per day
for a deficiency based on an isolated incident in violation of
established hospice policy.
(4) Middle range of penalty. Penalties in the range of $1,500 up to
$8,500, as adjusted annually under 45 CFR part 102, per day of
noncompliance are imposed for a repeat or condition-level deficiency or
both that does not constitute immediate jeopardy but is directly
related to poor quality patient care outcomes.
(5) Lower range of penalty. Penalties in this range of $500 to
$4,000, as adjusted annually under 45 CFR part 102, are imposed for a
repeat or condition-level deficiency or both that does not constitute
immediate jeopardy and that are related predominately to structure or
process-oriented conditions rather than directly related to patient
care outcomes.
(6) Per instance penalty. Penalty imposed per instance of
noncompliance may be assessed for one or more singular events of
condition-level deficiency that are identified and where the
noncompliance was corrected during the onsite survey. When penalties
are imposed for per instance of noncompliance, or more than one per
instance of noncompliance, the penalties will be in the range of $1,000
to $10,000 per instance, not to exceed $10,000 each day of
noncompliance, as adjusted annually under 45 CFR part 102.
(7) Decreased penalty amounts. If the immediate jeopardy situation
is removed, but a condition-level deficiency exists, CMS shifts the
penalty amount imposed per day from the upper range to the middle or
lower range. An earnest effort to correct any systemic causes of
deficiencies and sustain improvement must be evident.
(8) Increased penalty amounts. (i) In accordance with paragraph
(b)(2) of this section, CMS increases the per day penalty amount for
any condition-level deficiency or deficiencies which, after imposition
of a lower-level penalty amount, become sufficiently serious to pose
potential harm or immediate jeopardy.
(ii) CMS increases the per day penalty amount for deficiencies that
are not corrected and found again at the time of revisit survey(s) for
which a lower-level penalty amount was previously imposed.
(iii) CMS may impose a more severe amount of penalties for repeated
noncompliance with the same condition-level deficiency or uncorrected
deficiencies from a prior survey.
(c) Procedures--(1) Notice of intent. CMS provides the hospice
program with written notice of the intent to impose a civil money
penalty in accordance with 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) Accural of per day
penalty. (i) The per day civil money penalty may start accruing as
early as the beginning of the last day of the survey that determines
that the hospice program was out of compliance, as determined by CMS.
(ii) A civil money penalty for each per instance of noncompliance
is imposed in a specific amount for that particular deficiency, with a
maximum of $10,000 per day per hospice program.
(2) Duration of per day penalty when there is immediate jeopardy.
(i) In the case of noncompliance that poses immediate jeopardy, CMS
must terminate the provider agreement within 23 calendar days after the
last day of the survey if the immediate jeopardy is not removed.
(ii) A penalty imposed per day of noncompliance will stop accruing
on the day the provider agreement is terminated or the hospice program
achieves substantial compliance, whichever occurs first.
(3) Duration of penalty when there is no immediate jeopardy. (i) In
the case of noncompliance that does not pose immediate jeopardy, the
daily accrual of per day civil money penalties is imposed for the days
of noncompliance prior to the notice of intent specified in paragraph
(c)(1) of this section and an additional period of no longer than 6
months following the last day of the survey.
(ii) If the hospice program has not achieved compliance with the
conditions of participation within 6 months following the last day of
the survey, CMS terminates the provider agreement. The accrual of civil
money penalty stops on the day the hospice program agreement is
terminated or the hospice program achieves substantial compliance,
whichever is earlier.
(e) Computation and notice of total penalty amount. (1) When a
civil money penalty is imposed on a per day basis and the hospice
program achieves compliance with the conditions of participation as
determined by a revisit survey, once the administrative determination
is final, CMS sends a final notice to the hospice program containing of
the following information:
(i) The amount of penalty assessed per day.
(ii) The total number of days of noncompliance.
(iii) The total amount due.
(iv) The due date of the penalty.
(v) The rate of interest to be assessed on any unpaid balance
beginning on the due date, as provided in paragraph (f)(6) of this
section.
(2) When a civil money penalty is imposed per instance of
noncompliance, once the administrative determination is final, CMS
sends a final notice to the hospice program containing all of the
following information:
(i) The amount of the penalty that was assessed.
(ii) The total amount due.
(iii) The due date of the penalty.
(iv) The rate of interest to be assessed on any unpaid balance
beginning on the due date, as provided in paragraph (f)(6) of this
section.
(3) In the case of a hospice program for which the provider
agreement has been involuntarily terminated, CMS sends the final notice
after one of the following actions has occurred:
(i) The administrative determination is final.
(ii) The hospice program has waived its right to a hearing in
accordance with paragraph (c)(2)(ii) of this section.
(iii) Time for requesting a hearing has expired and the hospice
program has not requested a hearing.
(f) Due date for payment of penalty. A penalty is due and payable
15 calendar days from notice of the final administrative decision.
[[Page 36014]]
(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 this remedy, CMS notifies the
hospice program in accordance with Sec. 488.1210(e).
(2) CMS or the temporary manager (with CMS approval) may direct the
hospice program to take corrective action to achieve specific outcomes
within specific timeframes.
(c) Duration and effect of remedy. If the hospice program fails to
achieve compliance with the conditions of participation within the
timeframes specified in the directed plan of correction, which may not
to exceed 6 months, CMS does one of the following:
(1) May impose one or more other remedies set forth in 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 this remedy,
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, (with the exception of
suspension of all payment) has been imposed on the hospice program and
termination has not been imposed.
(ii) The hospice program has submitted a plan of correction
approved by CMS.
(iii) The hospice program agrees to repay the Federal government
payments received under this provision if corrective action is not
taken in accordance with the approved plan and timetable for corrective
action.
(2) Termination. CMS may terminate the hospice program's provider
agreement any time if the criteria in paragraph (a)(1) of this section
are not met.
(b) Cessation of payments for new admissions. If termination is
imposed, either on its own or in addition to an enforcement remedy or
remedies, or if any of the criteria set forth in paragraph (a)(1) of
this section are not met, the hospice program will receive no Medicare
payments, as applicable, for new admissions following the last day of
the survey.
(c) Failure to achieve compliance with the conditions of
participation. If the hospice program does not achieve compliance with
the conditions of participation by the end of the period specified in
paragraph (a) of this section, CMS terminates the provider agreement of
the hospice program in accordance with 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).
[[Page 36015]]
(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
25. The authority citation for part 489 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc,
1395ff, and 1395(hh).
0
26. 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 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
27. Section 489.53 is amended in paragraph (a)(17) by removing the
phrase ``an HHA,'' and adding in its place the phrase ``an HHA or
hospice program,''.
PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTICIPATION OF ICFS/IID AND CERTAIN NFs IN THE
MEDICAID PROGRAM
0
28. The authority citation for part 498 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.
0
29. 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
30. 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
[[Page 36016]]
Sec. Sec. 488.845(h) and 488.1195(h) of this chapter); or
* * * * *
Sec. 498.60 [Amended]
0
31. 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: June 23, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-13763 Filed 6-28-21; 4:15 pm]
BILLING CODE 4120-01-P
