Medicaid Program and CHIP; Mandatory Medicaid and Children's Health Insurance Program (CHIP) Core Set Reporting
| Court | Centers For Medicare & Medicaid Services |
| Citation | 88 FR 60278 |
| Published date | 31 August 2023 |
| Record Number | 2023-18669 |
| Section | Rules and Regulations |
Federal Register, Volume 88 Issue 168 (Thursday, August 31, 2023)
[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Rules and Regulations]
[Pages 60278-60315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18669]
[[Page 60277]]
Vol. 88
Thursday,
No. 168
August 31, 2023
Part II Department of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------42 CFR Parts 433, 437, and 457Medicaid Program and CHIP; Mandatory Medicaid and Children's Health
Insurance Program (CHIP) Core Set Reporting; Final Rule
Federal Register / Vol. 88 , No. 168 / Thursday, August 31, 2023 /
Rules and Regulations
[[Page 60278]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 433, 437, and 457
[CMS-2440-F]
RIN 0938-AU52
Medicaid Program and CHIP; Mandatory Medicaid and Children's
Health Insurance Program (CHIP) Core Set Reporting
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This document establishes requirements for mandatory annual
State reporting of the Core Set of Children's Health Care Quality
Measures for Medicaid and the Children's Health Insurance Program
(CHIP), the behavioral health measures on the Core Set of Adult Health
Care Quality Measures for Medicaid, and the Core Sets of Health Home
Quality Measures for Medicaid.
DATES:
Effective Date: These regulations are effective January 1, 2024.
Applicability Date: The initial round (2024) of Core Sets reporting
must be submitted and certified by States by December 31, 2024.
FOR FURTHER INFORMATION CONTACT: Virginia Raney, (410) 786-6117,
Children and Adults Health Care Quality Measurement.
Sara Rhoades, (410) 786-4484, Health Home Quality Measurement.
Candace Anderson, (410) 786-1553, Health Care Quality Measurement
for Dually Eligible (Medicaid and Medicare) Beneficiaries.
SUPPLEMENTARY INFORMATION:
I. Background
A. Quality Measurement in Medicaid and CHIP
Medicaid was enacted in 1965 as Title XIX of the Social Security
Act (the Act) to provide health coverage for certain groups of people
with lower incomes. In 1997, upon enactment of the Balanced Budget Act
of 1997 (Pub. L. 105-33, enacted August 5, 1997), the Children's Health
Insurance Program (CHIP) was enacted as Title XXI of the Act. Combined,
as of April 2023, the two programs provided health coverage to more
than 94 million people, nearly half of whom are children (more than 42
million).\1\
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\1\ February 2023 Medicaid and CHIP Enrollment data: https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/april-2023-medicaid-chip-enrollment-trend-snapshot.pdf.
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Given the significant role that Medicaid and CHIP play in America's
health care system, this rule requires--for the first time--States, the
District of Columbia (DC) and certain territories to mandatorily report
on measures of the quality of health care provided to Medicaid and CHIP
beneficiaries.
The Children's Health Insurance Program Reauthorization Act of 2009
(CHIPRA) (Pub. L. 111-3, enacted February 4, 2009), established Federal
requirements regarding voluntary quality measurement to assess the care
delivered to beneficiaries in both Medicaid and CHIP.
Section 401 of CHIPRA added new section 1139A to the Act, which
required development of a Core Set of Children's Health Care Quality
Measures for Medicaid and CHIP (Child Core Set), which could be
voluntarily reported by States, and directed the Secretary to publish
for general comment an initial recommended core set of child health
quality measures based on existing quality of care measures for
children not later than January 1, 2010. To assist the Federal
Government in establishing priorities for the development and
advancement of the Child Core Set, section 1139A of the Act also
directed the Secretary to consult with a variety of specific interested
parties in developing the initial measures and to work with interested
parties annually to update the measures. CMS released the initial Child
Core Set, consisting of 24 measures, in 2009, with voluntary State-
level reporting beginning in Federal Fiscal Year (FFY) 2010.\2\
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\2\ Initial Child Core Set: https://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/SHO11001.pdf.
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Section 2701 of the Patient Protection and Affordable Care Act of
2010 (Pub. L. 111-148, enacted March 23, 2010) as amended and revised
by the Healthcare and Education Reconciliation Act (Pub. L. 111-152,
enacted March 30, 2010), referred to collectively as the Affordable
Care Act (ACA), added a new section 1139B of the Act, extending the
measurement of health care quality to Medicaid-eligible adults. While
not required by statute, including separate CHIP enrollees in reporting
on the Adult Core Set measures is encouraged; therefore, both Medicaid
and CHIP populations are referenced in descriptions of the Adult Core
Set (see additional discussion in section II.E. of the proposed rule).
CMS issued the initial Adult Core Set consisting of 26 quality measures
in 2012, and voluntary reporting of these measures began in FFY
2013.\3\
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\3\ Initial Adult Core Set: https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/cib-01-04-12.pdf.
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This rule implements mandatory annual reporting of the Child Core
Set and the behavioral health measures on the Adult Core Set using a
standardized format, as required by section 50102 of the Bipartisan
Budget Act of 2018 (Pub. L. 115-123, enacted February 9, 2018) and
section 5001 of the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT
Act), (Pub. L. 115-271, enacted October 24, 2018).
B. Quality Measurement of the Medicaid Health Home Benefits Under
Sections 1945 and 1945A of the Act
In addition to requiring reporting on the Child Core Set and
specified behavioral health measures on the Adult Core Set, this rule
establishes reporting requirements for States that elect to implement
one or both of the optional Medicaid health home benefits under
sections 1945 or 1945A of the Act. Section 1945 of the Act (added by
section 2703 of the ACA and later amended by section 1006(a) of the
SUPPORT Act) and section 1945A of the Act (added by section 3 of the
Medicaid Services Investment and Accountability Act of 2019) \4\ give
States options for implementing two different Medicaid health home
State plan benefits. The section 1945 health home benefit is for
Medicaid-eligible individuals who have (1) two or more chronic
conditions, as defined in section 1945(h)(2) of the Act, (2) at least
one chronic condition, as defined in section 1945(h)(2) of the Act, and
who are at risk for a second, or (3) at least one serious and
persistent mental health condition.\5\ The section 1945A health home
benefit is for Medicaid-eligible children with medically complex
conditions, as defined in section 1945A(i)(1) of the Act.\6\ States
were able to begin covering the section 1945 health home benefit on
[[Page 60279]]
January 1, 2011. States were able to begin covering the section 1945A
health home benefit on October 1, 2022.
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\4\ Public Law 116-16, enacted April 18, 2019.
\5\ On November 16, 2010, we issued State Medicaid Director
(SMD) letter #10-024, which provided States with guidance on
implementing the section 1945 health home benefit. See https://www.medicaid.gov/federal-policy-guidance/downloads/SMD10024.pdf.
\6\ On August 1, 2022, we issued SMD letter #22-004, which
provides States with guidance on implementing the section 1945A
health home benefit. See https://www.medicaid.gov/federal-policy-guidance/downloads/smd22004.pdf.
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As a condition for receiving payment for section 1945 health home
services, section 1945(g) of the Act requires section 1945 health home
providers to report to the State, in accordance with such requirements
as the Secretary shall specify, on all applicable measures for
determining the quality of health home services. Section 1945(c)(4)(B)
of the Act also requires certain States with an approved substance use
disorder (SUD)-focused section 1945 health home State plan amendment
(SPA) to report information to the Secretary on certain topics,
including on the quality of health care provided to SUD-eligible
individuals receiving health home services under the SUD-focused health
home SPA.\7\ Section 1945(c)(4)(B) of the Act further provides that the
Secretary shall specify all applicable quality measures that would be
included in the reporting required under that provision. Per section
1945(c)(4)(B) of the Act, States must submit the required report at the
end of the period of such SPA. We have interpreted this language to
mean that the report should provide data relating to the enhanced
Federal medical assistance percentage (FMAP) period available to the
State under section 1945(c)(4) of the Act and that States should submit
the report within 6 months after the enhanced FMAP period ends.\8\
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\7\ Center for Medicaid and CHIP Services (CMCS) Informational
Bulletin, ``New Reporting Measures for Substance Use Disorder (SUD)-
focused Health Homes,'' November 27, 2019, at https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf.
\8\ Under section 1945(c)(1) of the Act, State payments for
section 1945 health home services provided during the first 8 fiscal
year quarters that a section 1945 SPA is in effect are Federally
matched at a 90 percent Federal Medical Assistance Percentage
(FMAP). Section 1006(a) of the SUPPORT Act, ``Extension of Enhanced
FMAP for Certain Health Homes for Individuals with Substance Use
Disorders,'' amended section 1945(c) of the Act to permit an
extension of this period of 90 percent FMAP for certain section 1945
health home SPAs for individuals with substance use disorders (SUD)
for two additional quarters (such that there could be a total of 10
quarters for the 90 percent FMAP). CMS provided guidance to States
about this amendment to section 1945 in a May 7, 2019, Center for
Medicaid and CHIP Services (CMCS) Informational Bulletin (CIB),
``Guidance for States on the Availability of an Extension of the
Enhanced Federal Medical Assistance Percentage (FMAP) Period for
Certain Medicaid Health Homes for Individuals with Substance Use
Disorders (SUD),'' https://www.medicaid.gov/federal-policy-guidance/downloads/cib050719.pdf. We released further guidance on the section
1945(c)(4)(B) reporting requirements in a CIB entitled ``New
Reporting Measures for Substance Use Disorder (SUD)-Focused Health
Homes'' on November 27, 2019, https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf.
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Apart from the one-time-only required report under section
1945(c)(4)(B) of the Act, section 1945 of the Act does not require
States to submit quality measure reporting to CMS or the Secretary
related to the section 1945 health home benefit. However, since 2013,
we have encouraged States (including States subject to the one-time-
only report specified at section 1945(c)(4)(B) of the Act) to report
annually on a set of section 1945 health home quality measures (section
1945 Health Home Core Set).\9\ We published an initial core set of
section 1945 health home quality measures in 2013, with updates issued
annually. We also explained when publishing the initial core set of
section 1945 health home quality measures that reporting on the section
1945 Health Home Core Set would be voluntary until regulations were
promulgated to require it. However, to ease the reporting burden, all
but one of the recommended measures was aligned with measures in the
Adult Core Set.\10\ Subsequent updates to the section 1945 Health Home
Core Set have been made on an annual basis. In developing and updating
the section 1945 Health Home Core Set, we have generally tried to align
it with the Child and Adult Core Sets. In November 2019, we released a
Center for Medicaid and CHIP Services (CMCS) Informational Bulletin
(CIB), which added two additional measures specific to SUD-focused
health home programs to the 2020 section 1945 Health Home Core Set on
which States could consider reporting as part of the required reporting
under section 1945(c)(4)(B) of the Act.\11\
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\9\ SUD Health Home reporting CIB at https://www.medicaid.gov/
Federal-policy-guidance/downloads/cib112719.pdf.
\10\ Initial section 1945 Health Home Core Set: https://www.medicaid.gov/federal-policy-guidance/downloads/smd-13-001.pdf.
\11\ https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf.
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Section 1945A(g)(1)(B) of the Act requires section 1945A health
home providers to report information to the State on all applicable
measures for determining the quality of health home services provided
by the provider, including, to the extent applicable, child health
quality measures and measures for centers of excellence for children
with complex needs developed under Title XIX, Title XXI, and section
1139A of the Act (which would include the Child Core Set).
Additionally, unlike section 1945 of the Act, which requires States to
report on quality measures to the Secretary only if the State is
subject to section 1945(c)(4)(B) of the Act, section 1945A of the Act
requires all States implementing that benefit to submit reports to the
Secretary on a range of topics. Under section 1945A(g)(2)(A)(i) of the
Act, these reports must include all information reported by providers
to the State under section 1945A(g)(1) of the Act, including the
quality measure reporting required under section 1945A(g)(1)(B) of the
Act. We interpret the language in section 1945A(g)(2)(A)(i) of the Act
to refer to reporting on core measures developed for purposes of
evaluating the quality of section 1945A health home services, because
that provision cross-references the language in section 1945A(g)(1)(B)
of the Act that mentions quality measures developed under various
provisions of the Act, including the Child Core Set.
This rule establishes the following requirements for States
electing to implement the benefit under sections 1945 or 1945A of the
Act. Under the provisions of this rule, States that have implemented
the section 1945 and/or 1945A health home benefit must report annually
on the mandatory measures in the section 1945 Health Home Core Set and/
or a proposed section 1945A Health Home Core Set (depending on which of
the two benefits the State has opted to cover) and must require their
health home providers to report to the State on those measures. Annual
CMS reporting guidance will provide information on specific measures
for which reporting is mandatory for the section 1945 and section 1945A
Health Home Core Sets (including any specific measures that would be
mandatory for States with a SUD-focused section 1945 health home). For
States covering the section 1945 health home benefit, this requirement
is based on section 1902(a)(6) of the Act, which requires State
Medicaid agencies to make such reports, in such form and containing
such information, as the Secretary may from time to time require, and
to comply with such provisions as the Secretary may from time to time
find necessary to assure the correctness and verification of such
reports. For measures specific to States with SUD-focused health home
SPAs subject to section 1945(c)(4)(B) of the Act, this requirement is
also authorized by the language in section 1945(c)(4)(B) of the Act
stating that the Secretary shall specify all applicable measures for
determining quality for purposes of section 1945(c)(4)(B) of the Act,
but this rule does not otherwise address the reporting requirements
under section 1945(c)(4)(B) of the Act. Requiring States to require
their section 1945 health home providers to report to the State on the
Health Home Core Set is further supported by the language in
[[Page 60280]]
section 1945(g) of the Act providing that section 1945 health home
providers shall report to States on all applicable measures for
determining the quality of section 1945 health home services, in
accordance with such requirements as the Secretary shall specify. For
States covering the section 1945A health home benefit, these
requirements are authorized by section 1945A(g)(1) and (2) of the Act
(see discussion of those provisions above), as well as by section
1902(a)(6) of the Act. While this rule implements section
1945A(g)(2)(A)(i) of the Act, section 1945A(g)(2)(A) of the Act
requires States to report to the Secretary on several additional topics
that are not addressed in this rule. CMS expects to provide information
to States about the rest of the reporting requirements under section
1945A(g)(2)(A) of the Act in the future.
C. Building a System of Reporting To Improve the Quality of Care
Delivered
Implementation of the Child and Adult Core Sets, and the sections
1945 and 1945A Health Home Core Sets, represents a major step in the
development of a national, evidence-based system for measuring and
improving the quality of care delivered to Medicaid and CHIP
beneficiaries. The Core Sets include measures that, taken together, may
be used to estimate the overall national quality of health care
provided to beneficiaries. The ability to assess the quality of and
access to care furnished by State Medicaid and CHIP programs is
critical given that more than 93 million Americans receive coverage in
Medicaid and CHIP, and the annual expenditures for the programs are
over $600 billion.\12\
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\12\ January 2023 Medicaid and CHIP Enrollment data: https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/january-2023-medicaid-chip-enrollment-trend-snapshot.pdf; and https://www.medicaid.gov/state-overviews/scorecard/annual-medicaid-chip-expenditures/index.html.
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1. Development of Core Sets
To ensure that the measures included in the Child and Adult Core
Sets reflect the needs of Medicaid and CHIP beneficiaries and provide
the types of information necessary to assess the overall national
quality of health care, sections 1139A and 1139B of the Act establish a
number of specific parameters for the development of these core sets.
For a complete and full description of these requirements see sections
1139A and 1139B of the Act.
The initial section 1945 Health Home Core Set was established in
2013 as a recommended set of health care quality measures for assessing
the section 1945 health home service delivery model. We have updated
the section 1945 Health Home Core Set annually since 2013, and in 2021
we established a Health Home Annual Review Workgroup to align this
update process with the CMS process to annually update the Child and
Adult Core Sets (as further discussed below).
We formed a joint Child and Adult Core Sets Annual Review Workgroup
in 2019, consolidating what had previously been two separate
workgroups, to implement the statutory requirements and to ensure that
measures in the Core Sets are meaningful for States and interested
parties and feasible for State-level reporting.\13\ In 2021, the Health
Home Annual Review Workgroup was implemented, following the same
structure and guidelines as the workgroup for the Child and Adult Core
Sets, to develop and update section 1945 and section 1945A Health Home
Core Sets. The joint Child and Adult Core Sets Annual Review Workgroup
and the Health Home Annual Review Workgroup (``Workgroups'') develop
recommendations on how to revise, strengthen, and improve the
applicable Core Sets measures, and every year the Workgroups'
recommended changes are published for public comment and then submitted
to CMS. All meetings are open to the public, and public comment is
invited during each meeting.
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\13\ Annual Review and Selection Process: https://www.medicaid.gov/medicaid/quality-of-care/downloads/annual-core-set-review.pdf.
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D. Shifting From Voluntary to Mandatory Reporting
In 2018, Congress passed two laws that mandate State reporting of
the Child Core Set and the behavioral health measures on the Adult Core
Set. These laws help address the limitations of voluntary reporting and
significantly strengthen the ability of the Core Sets to drive quality
improvements for Medicaid and CHIP beneficiaries nationwide.
First, section 50102(b) of the Bipartisan Budget Act of 2018 (Pub.
L. 115-123, enacted February 9, 2018) added a new subparagraph (B) to
section 1139A(a)(4) of the Act to mandate annual reporting of the Child
Core Set beginning with the annual State report on FFY 2024.
Specifically, section 1139A(a)(4)(B) of the Act provides that beginning
with the annual State report on FFY 2024, the Secretary shall require
States to use the initial core measurement set and any updates or
changes to that set to report information regarding the quality of
pediatric health care under titles XIX and XXI. Additionally, section
1139A(a)(4)(B) of the Act requires, once mandatory reporting begins,
that States submit such information using the standardized format for
reporting information and procedures developed by CMS in consultation
with States in accordance with section 1139A(a)(4)(A) of the Act.
Second, section 5001 of the SUPPORT Act (Pub. L. 115-271, enacted
October 24, 2018), added a new subparagraph (B) to section 1139B(b)(3),
to make mandatory the annual reporting of behavioral health measures in
the Adult Core Set. The SUPPORT Act requirement also becomes effective
beginning with the annual State report on FFY 2024. Per section
1139B(b)(3)(B) of the Act, States are required to report on all
behavioral health measures included in the core set of adult health
quality measures and any updates or changes to such measures, and as
with the Child Core Set, reporting of the behavioral health measures
must be submitted using the standardized format for reporting
information and procedures developed by CMS in consultation with
States.
As discussed previously, this final rule also implements certain
statutory requirements in sections 1902(a)(6), 1945, and 1945A of the
Act to require States that have opted to implement the section 1945 or
section 1945A health home benefit to report on the section 1945 or
1945A Core Sets, as applicable, and also to require their health home
providers to report on the applicable health home core set.
II. Summary of the Proposed Provisions and Analysis of and Responses to
the Public Comments
We received 93 public comments from individuals and organizations,
including, but not limited to, State government agencies, non-profit
health care organizations, advocacy groups, associations, law firms,
managed care organizations, academic groups, tribal organizations, and
private citizens. We thank the commenters for their consideration of
the proposed requirements for mandatory reporting and appreciate the
submission of all of the comments received. In general, commenters
supported the proposed rule. In this section, arranged by subject area,
we summarize the proposed provisions, the public comments received, and
our responses. For a complete and full description of the proposed
mandatory reporting requirements, see the 2022 proposed rule,
``Medicaid Program and CHIP; Mandatory Medicaid and Children's Health
Insurance Program (CHIP) Core Set Reporting'' (87 FR 51303, August 22,
[[Page 60281]]
2022) hereafter referred to as the ``proposed rule''.
A. Basis, Scope, Purpose and Applicability
As discussed in section II.A. of the proposed rule, we proposed in
Sec. 437.1 to specify the basis and scope of the proposed requirements
and to establish the purpose of the Child Core Set, Adult Core Set, and
the Health Home Core Sets. We also proposed in Sec. 437.10 to
implement a process through which we would develop and update the Child
Core Set, Adult Core Set, and the Health Home Core Sets (sections 1945
and 1945A) and proposed in Sec. 437.10 the process through which we
would establish requirements that State agencies would have to meet
when reporting on the measures included in these Core Sets. We also
proposed in Sec. Sec. 437.10 and 437.15 the form, reporting, time, and
manner requirements for reporting the Core Sets. We proposed that the
requirements for Child and Adult Core Sets reporting would apply to the
50 States, DC, Puerto Rico, the Virgin Islands, and Guam; and
throughout the rule the term ``States'' is used to collectively refer
to these States and territories when we are referring to the Child and
Adult Core Sets. American Samoa and the Mariana Islands could, but
would not be required to, report Child and Adult Core Set measures. We
also proposed requirements for State reporting of health home quality
measures in Sec. Sec. 437.10 and 437.15 and noted the Secretary has
the authority under sections 1945(g) and 1945A(g) of the Act to require
States to require their health home providers to report on the Home
Health Core Sets measures. The requirement for reporting on one or both
of the Health Home Core Sets would apply to any State (as defined under
section 1101 of the Act for purposes of Title XIX) with an approved
Medicaid Health Home SPA under section 1945 or 1945A of the Act. We
also proposed, in Sec. 437.15(a)(1), to set the deadline to meet these
requirements for State reporting on the 2024 Core Sets as no later than
December 31, 2024.
In general, commenters who submitted public comments on the
proposed general requirements for mandatory reporting supported the
proposed scope, purpose, and process. We are finalizing those
provisions in Sec. Sec. 437.1, 437.10 and 437.15 with revisions to
Sec. 437.10 to specify timelines for Child and Adult Core Sets updates
and timelines for CMS reporting of Child and Adult Core Sets data. We
added Sec. 437.15(a)(1)(i) to specify timelines for the first year of
mandatory reporting of the Child Core Set and behavioral health
measures on the Adult Core Set. The addition of this new provision
shifted the numbering of the remainder of the provisions in Sec.
437.15(a)(1), redesignating Sec. 437.15(a)(1)(i) to Sec.
437.15(a)(1)(ii), etc. We also edited Sec. 437.15(a)(1)(iv),
originally proposed as Sec. 437.15(a)(1)(iii), to include only the
measures on the Adult Core Set that are not included in Sec.
437.15(a)(1)(i) and (ii) as optional for states to report, removing the
reference to the Health Home Core Sets to align with changes in other
sections. Below is a summary of the public comments we received related
to the scope, purpose, and applicability of the requirements as
proposed and our responses.
Comment: Several commenters supported the proposed rule in its
entirety or specifically indicated their support for reporting of a
specific component such as the behavioral health measures on the Adult
Core Set. Many of the comments referred to the positive outcomes that
CMS expects from finalization of these proposals. The commenters
generally expressed support for these proposals and noted that the
proposed changes to the requirements for reporting the Core Sets will
support the improvement of health outcomes for Medicaid and CHIP
beneficiaries overall in addition to addressing health disparities and
inequities.
Response: We appreciate the support for our proposal and thank
those who took the time to give us feedback.
Comment: Several commenters recommended the following revisions
(indicated below in bold typeface) to the proposed Sec. 437.1(c)(1):
``The purpose of the Medicaid and CHIP Child Core Set and the Medicaid
Adult Core Set is to measure the overall national quality of care for
beneficiaries; monitor performance and promote comparative analysis at
multiple levels, including the State, program, plan and provider
levels; and eliminate health disparities across populations; and
improve the quality of health care.'' They cite the following statutes:
Section 1139A(a)(8) of the Act to support the definition
of the Child Core Set as a ``group of valid, reliable, and evidence-
based quality measures.''
Section 1139A(b) of the Act established the Pediatric
Quality Measures program to advance the development of evidence-based
quality measures for children which, per sections 1139A(b)(2)(B) and
(C) of the Act, ``shall, at a minimum, be . . . designed to identify
and eliminate racial and ethnic disparities in child health and the
provision of health care'' and ``ensure that the data required for such
measures is collected and reported in a standard format that permits
comparison of quality and data at a State, plan, and provider level.''
Section 1139A(a)(3)(D) of the Act to highlight health
disparities and comparative analysis in its requirement that the
initial Child Core Set ``taken together, can be used to estimate the
overall national quality of health care for children, including
children with special needs, and to perform comparative analyses of
pediatric health care quality and racial, ethnic, and socioeconomic
disparities in child health and health care for children.''
Sections 1139B(a) and (b)(5) of the Act that direct the
Secretary to develop the Adult Core Set ``in the same manner'' as the
Child Core Set.
Response: We appreciate the suggestion to revise this section of
the regulation and agree with the commenters on the importance of
aligning quality measurement across multiple levels and measure sets,
as feasibility and applicability allow. We consider measuring and
reporting health disparities to be a cornerstone of CMS' approach to
advancing health equity and improving quality as outlined in the
proposed rule. The public comment recommending that the purpose of the
Child and Adult Core Sets include ``comparison of quality and data at a
State, program, plan, and provider level'' cites the statutory
requirement as section 1139A(b)(2)(C) of the Act. That statutory
requirement applies to measures developed under the pediatric quality
measures program and does not refer to the reporting requirements for
the Child Core Set, which are established in section 1139A(c) of the
Act and require ``Annual State Reports Regarding State-Specific Quality
of Care Measures Applied Under Medicaid or Chip.'' Section 1139A(c) of
the Act requires reporting of State-level Child Core Set data, and does
not require program-, plan- or provider-level reporting. In addition,
it does not necessarily require comparative analysis of such data.
There is similar language in section 1139B(d) of the Act, which
requires reporting of Adult Core Set data at the State-level. Given
these considerations, we are finalizing Sec. 437.1(c)(1) as proposed,
with the purpose of the Medicaid and CHIP Child Core Set and the
Medicaid Adult Core Set to measure the overall national quality of care
for beneficiaries, monitor performance at the State-level, and improve
the quality of health care.
Comment: Several commenters recommended that CMS add a provision to
the final rule to require CMS to
[[Page 60282]]
collect, analyze, and make publicly available Child and Adult Core Sets
data annually by September 30th. Other commenters recommended that CMS
add a provision to the final rule to require CMS to publish recommended
changes to the Child and Adult Core Set measures by January 1 of each
year.
Response: The statutory authority for the Core Sets at sections
1139A(c)(2) and 1139B(d)(2) of the Act requires the Secretary to
collect, analyze, and make publicly available, by September 30th of
each year, the information reported in the annual State reports
described in sections 1139A(c)(1) and 1139B(d)(1) of the Act.
Similarly, sections 1139A(b)(5) and 1139B(b)(5)(B) of the Act require
the Secretary to publish recommended changes to the Child and Adult
Core Sets by January 1st annually. We have historically followed this
timeline for updating Core Sets. To address the recommendations
received in public comments regarding the Child and Adult Core Sets to
add these provisions to the final rule, we added these requirements at
Sec. 437.10(a)(1) and (4). Although the comment is not specific to
Health Home Core Sets, we are specifying at Sec. 437.10(a)(5) that the
Secretary shall collect, analyze, and make publicly available data from
the Health Home Core Sets annually.
Comment: One commenter recommended that because most of the current
Health Home Core Sets measures have continuous enrollment periods of
``no gaps in coverage,'' ``no more than 45-day gap in coverage,'' and
``no more than 90-day gap in coverage,'' CMS should alter Sec.
437.15(a)(1)(ii) in the proposed rule from ``the applicable health home
program has an effective date and has been implemented more than 6
months prior to the December 31st reporting deadline'' to ``. . .
implemented for nine or more months . . .''
Response: In an effort to include as many active health home
programs as possible in quality measurement reporting, we believe it is
preferable to maintain the minimum requirement as it was proposed, even
if this means a health home program may lack sufficient data to report
on certain measures, as what a health home program can report will
still be useful to help us and the State to understand the quality of
care provided in the health home program. Specifically, the requirement
states that a health home program must report if it has been
implemented for more than 6 months prior to the December 31st reporting
deadline. Therefore, we are finalizing the proposed Sec.
437.15(a)(1)(ii) at Sec. 437.15(a)(1)(iii) (to accommodate addition of
a new provision at Sec. 437.15(a)(1)(i), as discussed previously in
this final rule) without other changes.
Comment: A few commenters expressed support for the proposed
changes but provided feedback on areas that were not addressed in the
proposed rule. One commenter noted that it is critical that health
plans reporting on Core Set quality measures have effective tools to
communicate with enrollees in order to ensure that enrollees understand
plan benefits and recommended health care screenings and services, and
that these plans can also address barriers to higher quality care. This
commenter requested that CMS issue guidance to States to help improve
communication with beneficiaries due to confusion regarding the
Telephone Consumer Protection Act (TCPA) (Pub. L. 102-243, enacted
December 20, 1991). Another commenter recommended that CMS work with
State Medicaid programs to remove undue pharmacy scope of practice
restrictions, and to adopt payment pathways that recognize pharmacists
as eligible providers and enable pharmacies to provide and be
reimbursed for clinical care interventions that improve the health and
wellbeing of beneficiaries. Another commenter suggested CMS consider a
pilot to apply the pediatric measures to all payers, starting with
States with all-payer claims databases as this would help demonstrate
the impact of different interventions on children's health more broadly
and may address some of the ``small numbers'' challenges when looking
at subgroups of children, such as children with special health care
needs. Lastly, one commenter recommended the development of national
standards for assessing access to Medicaid and CHIP services to include
at minimum: time and distance standards, coverage of reimbursement for
a variety of health care services, and consistent standards across fee-
for-service (FFS) and managed care.
Response: We thank the commenters for their support of the proposed
requirements for mandatory reporting and appreciate the submission of
these comments but note that these areas are outside of the scope of
this rulemaking.
Comment: One commenter requested confirmation that States with
section 1115 demonstrations are included in mandatory reporting.
Response: States are required to report mandatory Core Set measures
for all required populations, even if those beneficiaries are enrolled
in a section 1115 demonstration. States with section 1115
demonstrations are required under demonstration Special Terms and
Conditions (STCs) to monitor their demonstration's performance. Section
1115 demonstration monitoring and reporting requirements are in
addition to and not in lieu of requirements for State-level Core Set
reporting as outlined in this final rule. As part of the demonstration
monitoring process, we may require that States report a select set of
Core Set measures that support assessing performance and progress
toward specific goals and objectives of the demonstration. This
reporting, which may be adapted for demonstration populations, is in
addition to mandatory Core Set reporting. Additionally, States may
leverage Core Set measures as part of their section 1115 demonstration
evaluation.
Comment: Several commenters recommended that CMS streamline the
language in Sec. 437.15(a) to remove references to the specific sets
of measures (that is, the Child Core Set or behavioral health measures
on the Adult Core Set) that will become mandatory under this final rule
as redundant, noting that section 1139B of the Act does not preclude
CMS from using its authority under section 1902(a)(4) of the Act to
require reporting on additional measures if necessary to ensure the
proper and efficient administration of the Medicaid program. Other
commenters encouraged CMS to consider its independent authority,
outside of sections 1139A and 1139B of the Act to require mandatory
reporting of additional measures to advance quality in Medicaid through
section 1902(a)(6) of the Act.
Response: We believe the Congressional intent is for mandatory
reporting to apply to the Child Core Set and the behavioral health
measures of the Adult Core Set, and not to apply to the remaining
quality measures. For the Child and Adult Core Sets, this rulemaking is
not proposing to make mandatory any measures beyond those under
sections 1139A and 1139B of the Act. Therefore, we are maintaining the
proposed scope of mandatory reporting and are not making any changes to
Sec. 437.15(a) in response to this comment.
Comment: One commenter urged CMS to consider ways to help address
any burden that new data collection efforts may cause for States by
exploring funding opportunities to assist States in conducting the
necessary activities to implement these important provisions
effectively.
Response: We appreciate the submission of this comment but note
that this issue is outside of the scope of this rulemaking. As noted in
the proposed rule, in Medicaid, enhanced
[[Page 60283]]
Federal Financial Participation (FFP) is available at 90 percent for
the design, development, and installation (including of enhancements)
of mechanized claims processing and information retrieval systems, and
75 percent enhanced FFP is available for operations of such systems, in
accordance with applicable Federal requirements.\14\ Receipt of these
enhanced Federal Medicaid matching rates is conditioned upon States
meeting a series of standards and conditions.\15\ Additionally, under
section 1903(a)(3)(A)(iii) of the Act, the FFP for State expenditures
on systems development or modifications necessary for efficient
collection and reporting on the Child Core Set is at the State's FMAP
under section 1905(b) of the Act. We also note that under section
1903(a)(7) of the Act, Federal Medicaid matching funds may be available
at a 50 percent Federal match rate for staffing and contracting related
to implementing Core Set reporting requirements, as these activities
might, subject to certain conditions, be necessary for the proper and
efficient administration of the State plan. To the extent these system
expenditures are attributable to a State's CHIP (Medicaid Expansion
CHIP (MCHIP), or separate CHIP), cost-allocation methodologies set
forth in 45 CFR part 75 apply. For the CHIP-funded portion of the
expenditure, States can claim at a State's CHIP enhanced FMAP (eFMAP)
available under section 2105(b) of the Act. We note that systems
expenditures are administrative expenditures, and CHIP administrative
funding is limited to 10 percent of either a State's total computable
allotments for a FFY or its total expenditures reported for a FFY,
whichever is lower.\16\
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\14\ See section 1903(a)(3)(A)(i) and (B) of the Act, Sec.
433.15(b)(3) and (4), and subpart C of 42 CFR part 433.
\15\ 42 CFR 433.112 and 42 CFR 433.116.
\16\ See 42 CFR 457.618(e)(1).
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B. Definitions
As discussed in section II.B. of the proposed rule, in Sec. 437.5
we proposed the definitions related to quality measurement and
reporting. Commenters generally supported the proposed definitions, and
we are finalizing these provisions with a revision to the definition of
behavioral health in Sec. 437.5 and other minor wording changes to
clarify cross-references within the same subpart. Below is a summary of
the public comments we received regarding this section and our
responses.
Comment: Several commenters recommended that CMS revise (with
revisions indicated in boldface type below) the definition of
``behavioral health'' proposed at Sec. 437.5: ``Behavioral health
means a beneficiary's whole emotional and mental well-being, which
includes, but is not limited to, the prevention, treatment and recovery
from mental disorders and substance use disorders.'' The commenters
recommended adding ``and recovery'' to the meaning of behavioral health
and replace ``including'' with ``and'' regarding the inclusion of
substance use disorders in this definition.
Response: We agree with the recommendation to add ``and recovery,''
as recovery is a key part of improving the health outcomes for
individuals with behavioral health conditions, and are revising the
definition of behavioral health in Sec. 437.5 of this final rule.\17\
Regarding the second suggestion, we will retain the language as
originally proposed, ``mental disorders including substance use
disorders,'' as that aligns with the American Psychiatric Association's
position, reflected in the Diagnostic and Statistical Manual of Mental
Disorders (DSM-5), that substance use disorders are included in the
definition of mental disorders.
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\17\ CMS Behavioral Health Strategy: https://www.cms.gov/cms-behavioral-health-strategy.
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Comment: Several commenters supported CMS' proposal to broadly
define ``behavioral health'' and ``behavioral health measures.'' Some
commenters recommended additional guidance on the potential scope of
conditions and quality measures included in the definition to ensure a
shared understanding of such definitions and help prepare for
reporting.
Response: We appreciate the support for the proposed ``behavioral
health'' definition, which aligns with the behavioral health conditions
included in the American Psychiatric Association's DSM-5. We plan to
use the DSM-5 as a resource in determining which measures on the Adult
Core Set should be considered behavioral health measures and thus
subject to mandatory reporting requirements and will specify these
measures in annual reporting guidance. In November 2022, we issued the
annual CIB updating the Core Sets, the 2023-2024 Core Sets measure
lists, to include a subset of measures identified as the Behavioral
Health Core Set, which includes all the behavioral health measures on
the Adult Core Set.18 19 As noted, we are finalizing the
definition in Sec. 437.5 with one revision, to add ``and recovery.''
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\18\ 2022 Core Set CIB: https://www.medicaid.gov/sites/default/files/2022-11/cib111522_0.pdf.
\19\ 2023-2024 Behavioral Health Core Set: https://www.medicaid.gov/sites/default/files/2022-11/2023-bh-core-set.pdf.
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C. The Child, Adult, and Health Home Core Sets
As discussed in section II.C. of the proposed rule, in Sec. 437.10
we proposed to continue the existing annual process of identifying and
updating the measures comprising the Child, Adult, and Health Home Core
Sets through annual consultation with States and other interested
parties to establish priorities for the development and advancement of
the Child, Adult, and both Health Home Core Sets. We proposed in Sec.
437.10(a)(2) to identify any gaps in the measures included in each Core
Set; to identify measures which should be removed because they no
longer strengthened the Core Sets; and to ensure that all measures
included in the Core Sets would reflect an evidence-based process
(including testing, validation, and consensus among interested
parties). The measure(s) selected would be meaningful for States and
feasible for State-level and/or health-home program level reporting, as
appropriate.
Commenters generally supported the process proposed in Sec.
437.10(a) and (e) by which we would update the Core Sets and publicly
report data on such measures. Commenters also asked several questions
about specific measures on the Core sets. We will be finalizing these
provisions in this final rule with a revision to Sec. 437.10(a)(iv),
where we describe measure criteria for the Core Sets, and with
revisions to Sec. Sec. 437.10(b) and 437.15(a), where we have provided
additional detail on reporting requirements, and we discuss these
changes further in sections II.D.2. and II.D.3. of this final rule.
Below is a summary of the public comments we received regarding this
section and our responses.
Comment: Several commenters provided feedback on areas that were
not addressed in the proposed rule such as: proposing specific changes
to the Core Sets, proposing measure additions or removals, identifying
measure gaps on the Core Sets, adding non-behavioral health measures to
the list of Adult Core Set measures required in mandatory reporting,
and measure development and testing. Specifically, a few commenters
recommended a ``duration of coverage'' measure as called for by
existing statute (section 1139A(a)(3)(A) of the Act) to assess the
negative impact of churn on the quality of care that children receive
and recommended that this measure be added to the Child Core Set no
later than mandatory reporting for 2024.
[[Page 60284]]
Response: We appreciate the submission of these comments, and we
will consider these comments as part of the measure adoption
subregulatory process. We encourage the commenters to attend meetings
of the joint Child and Adult Core Sets Annual Review Workgroup and the
Health Home Annual Review Workgroup (Workgroups), which are convened
annually to develop recommendations on how to revise, strengthen, and
improve the applicable Core Sets measures.\20\ All meetings are open to
the public, public comment is invited during each meeting, and every
year the Workgroup recommendations are published for public
comment.\21\
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\20\ https://www.medicaid.gov/medicaid/quality-of-care/downloads/annual-core-set-review-11102022.pdf.
\21\ https://www.mathematica.org/features/maccoresetreview.
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We agree with the commenters regarding the importance of
understanding the continuity of coverage among Medicaid and CHIP
beneficiaries, recognizing that disruptions in coverage can lead to
periods of uninsurance, delayed care, and reduced access to preventive
care and other essential care for beneficiaries. Beneficiaries moving
on and off Medicaid and CHIP coverage (sometimes called ``churning'')
can lead to higher administrative costs, less predictable State
expenditures, and higher monthly health care costs due to pent-up
demand for health care services. To help address this issue, section
5112 of subtitle B of title V of division FF of the Consolidated
Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-328), which was
signed into law December 29, 2022, requires all States to provide 12
months of continuous eligibility for most children under the age of 19
in Medicaid and CHIP, effective January 1, 2024. There are no existing
standardized quality measures in this area; however, we published a
data brief in November 2022 on Medicaid and CHIP Access: Coverage and
Behavioral Health Data Spotlight, which provides in depth data on
continuity of coverage.\22\ We will consider the best venue for
continued reporting of these important metrics.
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\22\ https://www.medicaid.gov/medicaid/access-care/index.html.
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Comment: One commenter encouraged CMS to consider making the
National Core Indicators Survey (NCIDD-AD) within the Adult Core Set a
voluntary component, because they believe that there would be a low
response rate to this survey, which is administered in person.
Response: While we appreciate the submission of this comment, the
issue of which specific measures will be voluntary versus mandatory
will be considered in the subregulatory measure revision process
described previously in this final rule. The NCIDD-AD measure is an
experience of care survey that was added to the Adult Core Set to
address a gap in measures for long-term services and supports. It has
not been identified as a behavioral health measure and will not become
mandatory for State reporting in 2024. Measure administration and
technical specifications are set by the measure steward, the National
Association of State Directors of Developmental Disabilities Services
and Human Services Research Institute.
Comment: One commenter encouraged CMS to work with States to ensure
that contraceptive care measures are used appropriately in the Child
Core Set without reference to an external benchmark that may suggest an
appropriate level of contraceptive use, and without provider incentives
that could promote forms of coercion.
Response: This comment is outside the scope of rulemaking. However,
we appreciate this comment identifying potential issues related to the
appropriate use and interpretation of the contraceptive care measure
results. Specific to the Contraceptive Care measure, we note that we do
not publish a benchmark for this measure, which examines provision of a
most or moderately effective method of contraception and provision of a
long-acting reversible method of contraception. The lack of benchmark
reflects that some individuals will make informed decisions to choose
methods in the lower tier of efficacy even when offered the full range
of methods.\23\ To help ensure that data users understand that the goal
is not prescribing contraceptives to 100 percent of women, we include
language in public reporting (that is, the Child Core Set Chart Pack)
\24\ indicating the estimated percentage in need of contraceptive
services. Additionally, we cite resources from Office of Population
Affairs (OPA) with language about the goal and guidance for how to
interpret the measure.\25\
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\23\ https://opa.hhs.gov/research-evaluation/title-x-services-research/contraceptive-care-measures.
\24\ Annual Reporting on the Child Core Set: https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html#AnnualReporting.
\25\ https://opa.hhs.gov/sites/default/files/2020-07/interpreting-rates-for-contraceptive-care-measures.pdf.
---------------------------------------------------------------------------
Comment: Several commenters recommended that CMS not use the Core
Set data for State comparisons without accounting for State variation,
including program and benefit design, geography and resources, and
beneficiary characteristics.
Response: We appreciate the submission of these comments and will
take this feedback into consideration when developing Core Set
reporting guidance and materials for public reporting.
Comment: One commenter requested that the Secretary require managed
care organizations (MCOs) to deliver stratified data in a timely manner
to Federally Qualified Health Centers (FQHCs), facilities, and
providers.
Response: While we appreciate the submission of this comment, this
issue is outside the scope of this rulemaking.
Comment: Several commenters provided recommendations on our
publication of Core Set data, including that CMS limit phasing-in the
publication of State-level data to no more than 3 years; that CMS
publish all State-level data even if not enough States have reported
for CMS to conduct comparative analysis and to report quartile
rankings; that CMS reconsider its policy to limit public reporting of
voluntary Core Set measures to measures that are reported by at least
25 States; and that CMS publish standardized core measures data with
national benchmarks that would permit comparisons across States and
over time.
Response: We will continue to publish Core Set data annually, as
required under sections 1139A(c)(2) and 1139B(d)(2) of the Act for the
Child Core Set and the Adult Core Set, respectively. We have worked to
find a balance in the reporting of State data that meets these
statutory reporting requirements while taking into consideration data
quality and the ability to conduct comparative analysis. We appreciate
the submission of these comments and will take them into consideration
as we review State data as well as for future policymaking.
Comment: Several commenters recommended that CMS seek to align the
Core Set measures with other national reporting systems such as the
Core Quality Measures Collaborative (CQMC) or the Medicaid and CHIP
Quality Rating System (MAC QRS) in order to minimize additional
reporting burden on providers and to ensure parsimony, alignment,
harmonization, and the avoidance of competing quality measures. Other
commenters noted that CMS should align with measures appropriate for
State health care goals as defined by the National Committee for
[[Page 60285]]
Quality Assurance (NCQA), National Quality Forum (NQF), and the
Utilization Review Accreditation Commission (URAC).
Response: We agree with the commenters on the importance of
parsimony, alignment and harmonization in quality measurement and will
consider these comments for subsequent rulemaking. Throughout the
annual Core Set review process, we facilitate measure alignment through
engagement with a variety of internal and external interested parties,
Federal partners, other reporting systems related to Medicaid and CHIP,
and Medicare and Marketplace quality programs, as well as through
initiatives such as the Universal Foundation, a set of quality measures
around which programs at CMS are aligned.\26\ In some cases, we may use
different measures in order to capture quality at different levels of
the health system, such as at the State level. Given that these
processes are in place, we are not making changes to Sec. 437.10(a) in
response to these comments.
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\26\ https://www.cms.gov/files/document/2024-advance-notice-pdf.pdf.
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Comment: Several commenters stated that that the proposed language
requiring consideration of regulatory burden would hinder CMS' ability
to add new measures to the Core Sets and to require States to report
measures by specific populations or demographic characteristics. They
recommended amending the proposed Sec. 437.10(a)(2)(iv) to delete the
reference to burden to the States as follows (edits in bold): ``(iv)
Ensure that all measures included in the Core Sets reflect an evidence-
based process including testing, validation, and consensus among
interested parties; are meaningful for States; and are feasible for
State-level and/or Health Home program level reporting as
appropriate.''
Response: We agree with this comment that this language is open to
interpretation and therefore accept the suggestion to revise Sec.
437.10(a)(2)(iv) to remove the language ``and represent minimal
additional burden to States.'' The remaining language in the provision
regarding feasibility will help to ensure that we will not overburden
States when adding measures to the Core Sets, and we agree that the
additional language about minimal additional burden may hinder our
ability to require more complex measures and stratification over time.
While section 1945A(g)(2)(A) of the Act, which applies to the section
1945A Health Home Core Set, requires any State reporting under that
provision to be ``in such form and manner determined by the Secretary
to be reasonable and minimally burdensome,'' this requirement applies
to CMS regardless of whether it is repeated in CMS' regulations. We
believe that we can and will meet this requirement by taking multiple
steps and intend to keep doing so for all Core Sets. For example, as
specified in Sec. 437.10(a) and (e) of the proposed rule, States and
providers of health home services under sections 1945 and 1945A of the
Act are among the interested parties that are consulted in development
of the Core Sets, and this process is designed to consider burden of
reporting in measure selection. We have already released the list of
measures included in the 2024 Child, Adult, and section 1945 Health
Home Core Sets.\27\ Additionally, we have released the list of measures
under consideration for the 2024 section 1945A Health Home Core Set to
allow States and health home programs time to prepare.\28\ We also aim
to align measures across programs as much as possible, and to identify
measures for additional reporting that States already have the
infrastructure to calculate. For example, the section 1945A Health Home
Core Set under consideration currently contains 7 quality measures, all
of which can be calculated using administrative claims data only.
---------------------------------------------------------------------------
\27\ CMS released both the 2023 and 2024 Child and Adult Core
Sets in November 2022 (https://www.medicaid.gov/federal-policy-guidance/downloads/cib111522.pdf) and the 2023 and 2024 Health Home
Core Sets in December 2022 (https://www.medicaid.gov/medicaid/quality-of-care/downloads/2023-health-home-core-set.pdf).
\28\ Proposed 1945A Health Home Core Set https://www.medicaid.gov/medicaid/quality-of-care/downloads/2024-1945a-health-home-core-set.pdf.
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Comment: One commenter recommended that CMS harmonize the Core Sets
so that reporting is not duplicated across different programs, such
that State reporting of the Child Core Set would mean that reporting
would not be required again for the subset of children included in the
health home. This commenter recommended that, for those children, only
the additional health home-specific measures should need to be
reported.
Response: While we aim to align measures across programs as much as
possible, the Child, Adult, and Health Home Core Sets data are reported
at different levels. Specifically, the Child and Adult Core Sets data
is reported to us at the State level, and Health Home Core Sets data is
reported to us at the program level. For this reason, the same
calculation cannot be used in both the Child Core Set or Adult Core Set
and either of the Health Home Core Sets, as States have not submitted
the data in their Child and Adult Core Sets reporting that would be
necessary for us to derive health home program rates from State-level
reporting. Regarding duplication of reporting, section 1945A(g)(1)(B)
of the Act requires section 1945A health home providers to report to
the State information on all applicable measures for determining the
quality of health home services provided by that health home provider,
including to the extent applicable, child health quality measures and
measures for centers of excellence for children with complex needs
developed under section 1139A of the Act. Per section 1945A(g)(2)(A)(i)
of the Act, the State then reports this information to us.
Comment: One commenter recommended that CMS remove measures which
do not have National Quality Forum (NQF) endorsement from the Core
Sets.
Response: We appreciate the submission of this comment, and it will
be considered in the subregulatory measure identification process.
However, we note that statute (sections 1139A and 1139B of the Act)
does not limit the Child and Adult Core Sets to measures with NQF
endorsement and, as required under the statute (sections 1139A and
1139B of the Act) for Child and Adult Core Sets, measures are selected
through the Annual Core Set Workgroup process established by CMS.
Health Home Core Sets are also selected through the Annual Core Set
Workgroup process established by CMS, even though this process is not
statutorily required for these core sets.
Comment: Several commenters recommended that CMS review the list of
individuals who participate in the Annual Core Set Workgroup to ensure
meaningful representation from beneficiaries of all ages and their
advocates, including people with disabilities and behavioral health
disorders (including substance use disorders). Several commenters
requested that the Workgroup have representation of specific types of
organizations and individuals, including but not limited to:
beneficiaries, MCOs, purchasers of health care, providers and consumers
and/or national organizations that represent adults, FQHCs, pharmacies
and pharmacists, providers and health care professionals, and
beneficiaries served through a Health Home (this would apply only to
the Health Home Core Sets).
Response: We appreciate the submission of these comments and will
take them into consideration as we organize future Workgroups. All
[[Page 60286]]
Workgroup meetings are open to the public, and public comment is
invited during each meeting.
Comment: One commenter recommended that CMS monitor the Workgroup
process to determine if interested parties' feedback is being
adequately addressed or if a formal rulemaking process is necessary.
Response: We appreciate the submission of this comment and will
take it into consideration as we organize future Workgroups and monitor
the public comment process.
Comment: One commenter recommended that CMS offer States and health
care organizations financial assistance to develop and deploy health
equity efforts, including funding support in addressing the capture of
self-reported data. Another commenter recommended that CMS require
States to submit plans for mitigating persistent disparities and
regularly report on their progress to close access and quality gaps.
Response: While we appreciate these comments, they are outside the
scope of this rulemaking, which addresses only Core Sets data and
measurement. However, we note that Medicaid and CHIP Federal matching
funds are available for State expenditures on the design, development,
and installation (including of enhancements), and for operation, of
mechanized claims processing and information retrieval systems. This
could include State expenditures related to operating such systems for
Core Sets reporting. We also note that under section 1903(a)(7) of the
Act, Federal matching funds are available for activities necessary for
the proper and efficient administration of the Medicaid State plan.
This may include improving data reporting, which could promote greater
health equity.
Comment: One commenter recommended that CMS examine and prioritize
the selection of Child Core Set measures that can provide actionable
data at the level of providers to continue to improve pediatric
outcomes and focus on health disparities and measures that can provide
the most value in terms of informing the quality of pediatric care.
Response: While we appreciate this comment, provider-level data is
outside the scope of the rulemaking, which addresses reporting at the
State and health home program level. We note also that the statutory
mission of the Child Core Set, as stated in section 1139A(3)(D) of the
Act, specifies ``the types of measures that, taken together, can be
used to estimate the overall national quality of health care for
children, including children with special needs, and to perform
comparative analyses of pediatric health care quality and racial,
ethnic, and socioeconomic disparities in child health and health care
for children.''
Comment: One commenter recommended that CMS improve the measure
sets' relevance to children with special health care needs and children
with medically complex conditions included in sections 1945 and 1945A
health home programs.
Response: We agree with the importance of reflecting all
populations that are served in both section 1945 and 1945A health home
programs in the Health Home Core Sets. The specific measures to be
included in the Health Home Core Sets, which are determined through the
workgroup process finalized in Sec. 437.10(a), will be released
through annual subregulatory guidance.
1. Annual Reporting Guidance
As discussed in section II.C.1. of the proposed rule, we proposed
in Sec. Sec. 437.10 and 437.15 to require that States use standardized
formats and procedures established by the Secretary when reporting on
the Child, Adult, and Health Home Core Sets. We also proposed in Sec.
437.10(a)(3) and (b) that we would develop and annually update the
reporting guidance needed by States to report on all applicable Core
Sets and described the components of the annual reporting guidance. For
a complete discussion of the components of the annual reporting
guidance, please refer to the proposed rule section II.C.1.
In general, commenters supported the proposed annual reporting
process, but requested clarification on what would be included in the
reporting guidance. We are finalizing these provisions with revisions
to Sec. Sec. 437.10(b) and 437.15(a), where we have provided
additional detail on reporting requirements. We discuss these revisions
in sections II.D.2. and II.D.3. of this final rule. Below is a summary
of the public comments we received regarding this section and our
responses.
Comment: Commenters noted that there are many details related to
the contents of reporting guidance that were not addressed by the
regulatory text. In particular, they asked for additional guidance as
to: (1) whether CMS would continue to arrange licensing agreements with
measure stewards related to the use and reporting of Core Set measures;
(2) how CMS would identify the mandatory measures, populations to be
included in mandatory reporting, and the process for reporting; (3) the
timeline for reporting new measures; and (4) attribution rules for
beneficiaries enrolled in different coverage during the reporting
period and how to operationalize them.
Response: To address concerns raised by these commenters, through
revisions to Sec. Sec. 437.10 and 437.15, we have provided additional
detail on reporting requirements and populations to be included in
mandatory reporting, and we discuss these revisions in sections II.D.2.
and II.D.3. of this final rule. We currently provide annual reporting
guidance to States to support voluntary reporting, and as explained in
this rule, this guidance will, in the future, include the requirements
associated with mandatory reporting and will continue to be updated
annually.\29\ As specified in Sec. 437.10(b), we will continue to
provide detailed reporting guidance annually to States, which will
include all of the information and technical specifications required
for reporting of each of the Core Set measures, including the mandatory
measures, populations to be included in mandatory reporting, the
process for reporting, the timeline for requiring reporting new
measures, and attribution rules and how to operationalize them. We will
continue to execute licensure agreements with measure stewards as
needed for States to report Core Set measures to CMS.
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\29\ Reporting guidance will be posted here: https://www.medicaid.gov/medicaid/quality-of-care/quality-of-care-performance-measurement/index.html.
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Comment: Multiple commenters recommended that, as future
modifications or additions are made to the Core Set, CMS issue
reporting guidance as soon as possible to give States, MCOs, and health
care providers time to prepare for reporting. Some commenters
recommended that CMS release reporting guidance in alignment with the
NCQA reporting guidance release, while others recommended that CMS set
a deadline for publishing reporting guidance by January 1st annually.
Response: We will take this feedback into consideration when
developing Core Set reporting guidance and materials for public
reporting. Measure stewards release updated guidance throughout the
calendar year. Due to the need to adapt the reporting guidance
developed by individual measure stewards, such as NCQA, for State-level
reporting, simultaneous release of these materials with the measure
steward is not feasible. We recognize the time and effort it takes
States to prepare for Core Set reporting and expect to make every
effort to publish reporting guidance as
[[Page 60287]]
soon as possible following the release of the updated Core Sets.
Comment: Multiple commenters recommended that CMS consult MCOs and/
or behavioral health organizations (BHOs) as CMS develops annual
reporting guidance for States in order to promote awareness of these
resources, as many States rely on MCOs to provide data for reporting on
the Core Sets and will need to update their reporting systems to
implement standardized reporting. Another commenter recommended that
CMS clarify the role of MCOs in supporting providers and State agencies
in their efforts to improve Medicaid and CHIP quality measurement.
Response: As part of our annual process to update reporting
guidance, we review all of the technical assistance requests received
related to specific measures, which often include questions submitted
by MCOs/BHOs that are working on behalf of States to calculate Core
Sets measures. The publication of reporting guidance and any updates
regarding the Core Sets, including the publication of Core Set data
products, is disseminated through a public listserv.\30\ We defer to
each individual State's Medicaid and CHIP agencies to determine the
role MCOs and BHOs will have in in their State's Core Sets reporting
and efforts to improve quality measurement within their State.
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\30\ To join the Core Set listserv email:
[email protected].
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Comment: One commenter agreed with reporting data for partial-year
enrollees at the State level, but recommended against attributing these
data to specific MCOs if CMS stratifies reporting by health plan,
noting that MCOs would have limited opportunity to work with members to
accomplish necessary screenings and visits.
Response: Decisions regarding the continuous enrollment period and
allowable gaps are established by the measure stewards for each
measure. Core Set reporting applies to all beneficiaries who meet
enrollment criteria in State Medicaid and/or CHIP programs. We will
take this comment regarding health plan attribution into consideration
as we develop reporting guidance regarding attribution and
stratification categories.
2. Advancing Health Equity Through Data Stratification
Measuring and reporting on health disparities is a cornerstone of
CMS' approach to advancing health equity. As discussed in section
II.C.2. of the proposed rule, we proposed in Sec. 437.10(d)
requirements for stratification of Child, Adult, and Health Home Core
Set data to enable us to monitor health outcomes for disparities
between groups of individuals who may have different determinants of
health. This approach to data reporting and stratification is aligned
with Executive Order 13985, which calls for advancing equity for
underserved populations.\31\ We proposed that the annual reporting
guidance identify the specific measures in the Child Core Set, the
behavioral health measures on the Adult Core Set, and the Health Home
Core Sets that must be stratified by race, ethnicity, sex, age, rural/
urban status, disability, language, or such other factors as may be
specified by the Secretary. We note that in collecting and reporting
data in accordance with the requirements of this rule, States and
providers would be expected to comply with all applicable Federal non-
discrimination laws. We also note that data stratification is intended
to promote health equity for all patients and is not intended to
promote discrimination or to create a conflict between a CMS
requirement and a State's civil rights laws. Please refer to the
proposed rule, section II.C.2., for specific discussions of the method
for identifying measures for stratification, stratification factors,
data suppression policies, and proposed timeline for phased-in
stratification.
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\31\ Executive Order 13985: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
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We believe that this stratification of data in the Child Core Set,
Adult Core Set, and Health Home Core Sets measures is consistent with
our statutory authorities. Regarding the Child Core Set, section
1139A(b)(2)(B) of the Act specifies that measures under the pediatric
quality measures program shall be ``designed to identify and eliminate
racial and ethnic disparities in child health and the provision of
health care.'' In addition, section 1139A(a)(3)(D) of the Act required
that the initial Child Core Set contain the ``types of measures that,
taken together, can be used to estimate the overall national quality of
health care for children, including children with special needs, and to
perform comparative analyses of pediatric health care quality and
racial, ethnic, and socioeconomic disparities in child health and
health care for children.'' Regarding the Adult Core Set, section
1139B(a) of the Act requires the Secretary to utilize similar
parameters for establishing the Adult Core Set. Additionally, section
1902(a)(6) of the Act, which requires State Medicaid agencies to make
such reports, in such form and containing such information, as the
Secretary may from time to time require, authorizes us to require
stratification of the data that States report to us. Regarding the
Health Home Core Sets, in addition to the authority provided by section
1902(a)(6) of the Act, section 1945(g) of the Act requires section 1945
health home services providers to report to the State, in accordance
with such requirements as the Secretary shall specify, on all
applicable measures for determining the quality of such services.
Section 1945A(g)(2)(A)(i) of the Act requires States implementing the
section 1945A health home benefit to submit to the Secretary, in such
form and manner determined by the Secretary to be ``reasonable and
minimally burdensome,'' all section 1945A quality reporting data that
was submitted to them under section 1945A(g)(1) of the Act. The
information providers report to the State under section 1945A(g)(1)(B)
of the Act includes, to the extent applicable, child health quality
measures developed under section 1139A of the Act.
We received public comments on the proposed approach to
stratification of Core Set data, and in general, commenters supported
the proposed process. We are finalizing these provisions generally as
proposed in Sec. 437.10(b)(7) and (d), with minor wording changes.
Below is a summary of the public comments we received regarding this
section and our responses.
Comment: Several commenters supported the proposed requirement to
phase in stratified reporting over a period of 5 years and recommended
that the Secretary specify which measures must be stratified in order
to promote consistency and comparability across States rather than
allowing States to decide the measures and factors for which they will
submit stratified data each year. A few commenters recommended instead
that States be able to choose based on data availability or State
health care priorities. Multiple commenters also supported the proposed
requirements that States stratify certain measures by demographics,
health care delivery systems, and other characteristics to enable
better care comparisons and identification of health disparities. Some
commenters recommended that CMS ensure that stratified data be reported
for both managed care and FFS delivery systems. Several commenters
supported the improved and expanded
[[Page 60288]]
collection of data, and analysis of quality measures by population
(such as dually eligible individuals), stratification categories (such
as race and ethnicity or disability status), and delivery systems and
provider types. They noted that these activities would allow for the
deployment of strategies that better account for the needs of
beneficiaries and further understanding of barriers to care and health
disparities. One commenter also recommended that CMS make available
reporting guidance, information on potential or expected data sources,
and share examples of State data collection, organization, and lessons
learned.
Response: We worked to find a balance in the reporting of State
data that meets the statutory reporting requirements under sections
1139A(c)(2) and 1139B(d)(2) of the Act while taking into consideration
data quality and the ability to conduct comparative analysis, and we
determined that allowing States to choose which measures to stratify
based on data availability or State health care priorities would limit
our ability to publish standardized core measure data that could be
compared across States and over time. Therefore, in the methodology we
are finalizing in Sec. 437.10(b)(7) and (d), stratified reporting will
be phased in over a period of 5 years, and the Secretary will specify
which measures should be stratified and by which factors data will be
stratified. We will provide technical assistance to support mandatory
reporting of stratified data and will ensure that States have access to
reporting guidance and other tools in order to assist with annual
reporting.\32\
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\32\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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Comment: One commenter stated that the Core Sets were initially
developed as a within-State quality improvement tool. Because State
Medicaid programs vary greatly in eligibility and offerings, it is
important that proposed stratifications do not lead to State-to-State
comparison without consideration for the populations served. The
commenter also stated that stratifications would add to State reporting
burden while not adding additional value or information for
improvement, and recommended stratification be piloted first to
determine if it is needed.
Response: The Child Core Set was intended not only to provide
States with a tool to drive improvement for their enrollees but also to
provide an estimate of the overall national quality of health care for
children (section 1139A(a)(5) of the Act). As discussed previously in
this final rule, we believe that stratification of data in the Child
Core Set, Adult Core Set, and Health Home Core Sets measures is
consistent with our statutory authorities. Stratified Core Set quality
measure data will enable CMS and States to identify the health outcomes
of underserved populations as well as potential differences in health
outcomes between populations. Stratified data can also inform adoption
of broadly applicable quality improvement initiatives that address the
drivers of health disparities experienced by underserved populations.
Due to the variability across States in the populations served by
Medicaid and CHIP, and the different populations and health care
services included in each core measure, a pilot project using a subset
of States and/or measures would not provide sufficient data or results
that could be generalized to provide an understanding of differences in
health outcomes overall.
Comment: Several commenters submitted recommendations and requests
related to the details of stratified reporting, such as definitions of
specific categories, data suppression policies and how to handle
missing data, and different measures of delivery systems.
Response: We will take these comments into consideration when
developing annual reporting guidance. We are finalizing the list of
stratification factors in Sec. 437.10(b)(7) with minor edits, to
include race, ethnicity, sex, age, rural/urban status, disability, and
language, as well as additional factors as may be specified by the
Secretary and informed by annual consultation with States and
interested parties.
Comment: Several commenters recommended that consistent data
standards for stratification of race, ethnicity, and language, across
programs and agencies would clarify and facilitate data collection.
However, one commenter noted that new standards should not inhibit the
ability of States to tailor their data fields to reflect their
populations as long as they are able to be aggregated to Federal
categories and that any guidance provided by CMS in this area should
also recognize the experiences of people with multiple racial and/or
ethnic identities. Additionally, several commenters suggested that CMS
include a ``Middle Eastern or North African'' response among the race
and ethnicity measures, allowing for stratified health outcomes for a
population that experiences disparities.
Response: The specific response categories included in stratified
reporting will be addressed as part of the reporting guidance process
that is discussed in the rule. We will take these recommendations into
consideration when developing annual reporting guidance, considering
data availability, data quality, and burden to States. We expect to
align with Department of Health and Human Services (HHS) data standards
for stratification, based on the disaggregation of the 1997 Office of
Management and Budget (OMB) Statistical Policy Directive No 15.\33\ We
expect to update Core Set reporting stratification categories if there
are any changes to OMB or HHS Data Standards.
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\33\ The categories for HHS data standards for race and
ethnicity are based on the disaggregation of the OMB standard:
https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=53.
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Comment: One commenter recommended that unknown, missing, or
nonresponses on demographic variables be its own stratification
category with its own associated measure rate. Another commenter
recommended that CMS provide technical assistance to States on how to
collect and report race and ethnicity information, including how States
should handle large percentages of data records with ``unknown'' race
and ethnicity. Several commenters recommended that an optional category
for ``declined to answer'' or similar category be included in State
reporting. A few commenters recommended a methodology for identifying
beneficiaries with a disability based on disability questions from the
American Community Survey. Another commenter noted that there is not a
Federal standard defining ``disability'' and requested that CMS
establish one for consistency in reporting in this and other programs.
Response: We will take this feedback into consideration when
developing Core Set reporting guidance on stratification requirements.
This area of data collection and reporting is evolving rapidly, and we
expect to provide additional technical assistance and support in this
space in the future.
Comment: Several commenters supported all the proposed requirements
for stratification but recommended either faster or slower
implementation. Some commenters suggested that States be required to
report stratified data by the 2024 reporting period rather than phase
in this requirement. Another commenter noted that a shorter phase-in
period would not be overly burdensome to States given the enhanced
Federal
[[Page 60289]]
Medicaid match for upgrading computer systems for this kind of
reporting. Multiple commenters provided alternate phase-in schedules
for stratification of Core Set measures.
Response: We agree on the importance of reporting stratified data
to help identify and eliminate health disparities across populations.
Reporting of stratified data is a cornerstone of our approach to
advancing health equity, as outlined in the proposed rule. We
determined that a shorter phase-in period, such as between 1 and 4
years, would not likely be operationally feasible because of the
potential systems and contracting changes (to existing contracts or the
establishment of new contracts) that States may be required to make in
order to collect these data. For example, additional reporting
requirements may need to be added to State contracts, changes may be
needed to data sharing agreements with MCOs, and modifications of
databases or systems might be required to record new variables. Based
on discussions with States regarding the feasibility of reporting
stratified data, and the comments received supporting the proposed
timeframe, we have addressed the comments recommending a longer
duration of phase-in by revising Sec. 437.10(b)(5) to include
flexibility in the reporting of some populations in the initial years
of reporting the Child and Adult Core Sets. Of note, the section 1945A
health home benefit requires providers of that benefit to report to
States on quality measures as a condition of payment. The populations
which will be optional for States to include in reporting of the Child
and Adult Core Sets will be specified in annual subregulatory guidance.
In addition, we anticipate that States will not need more than 5 years
to implement systems and contracting changes, or any additional support
needed to report stratified data. We plan to work collaboratively with
States to provide the technical assistance and reporting guidance
necessary to support reporting of stratified data.\34\ While States may
be eligible for an increased Federal match for systems changes, States
still bear a share of the cost, and making the needed systems changes
is time-intensive, likely requiring several years or more to implement.
We have therefore determined that the proposed 5-year phased-in
approach to data stratification is reasonable and would also be
consistent with section 1945A(g)(2)(A) of the Act for 1945A health home
programs. With this approach, we are balancing our strong interest in
identifying differences in health outcomes between populations (as
supported by our statutory authorities, as discussed previously in this
final rule) with the operational challenges that States may face in
implementing these requirements. We are finalizing the proposed phase-
in time frames under Sec. 437.10(b)(7) and (d) as proposed. States
will thus be required to submit stratified data for 25 percent of the
measures on each of the Core Sets (the Child Core Set, behavioral
health measures within the Adult Core Set, and Health Home Core Sets)
for which the Secretary has specified that reporting should be
stratified by the second year of annual reporting after the effective
date of the final rule; 50 percent of such measures for the third and
fourth years of annual reporting after the effective date of the final
rule; and 100 percent of measures beginning in the fifth year of annual
reporting after the effective date of the final rule, on all factors as
specified by the Secretary pursuant to Sec. 437.10(b)(7), such as race
and ethnicity, sex, age, rural/urban, disability and language.
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\34\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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Comment: One commenter recommended that CMS modify the
stratification schedule to consider a phased-in approach based on the
stratification factor, for example, race, instead of the number of
measures.
Response: We appreciate this feedback and will consider it when
developing annual reporting guidance. Specific factors by which data
will by stratified will be delineated in annual reporting guidance, and
we will select these factors based on relevance and feasibility with
the plan to add over time as the quality and completeness of data
improve. We are finalizing Sec. 437.10(d) generally as proposed.
Comment: Multiple commenters recommended strategies for determining
which measures should be stratified first and by which stratification
factor(s) (that is, separate factors or multiple factors
simultaneously). These strategies included working collaboratively with
States and State-contracted entities, aligning with the measures and
timeline for stratification as determined by NCQA Healthcare
Effectiveness Data and Information Set (HEDIS) for their measures,
beginning the phase-in with measures that are currently stratified for
NCQA HEDIS reporting, and giving States the flexibility to decide the
measures and factors for which they will submit stratified data each
year. Several commenters recommended that CMS prioritize how measure
stratification is phased in based on the topics of most urgent need,
such as maternal and behavioral health, or measures addressing disease
prevention. Some commenters encouraged stratification of the Core Set
measures based on data obtained from the Consumer Assessment of
Healthcare Providers and Systems (CAHPS) survey, while others
encouraged CMS not to require stratified CAHPS data. Some commenters
encouraged CMS to ensure buy-in from interested parties such as States,
beneficiary groups, and providers on measures selected for
stratification so that States have adequate time to ensure that they
are reporting high quality data.
Response: We will take these ideas into consideration when
developing annual reporting guidance, and plan to work collaboratively
with States to provide the technical assistance and reporting guidance
necessary to support reporting of stratified data.\35\ We are
finalizing as proposed the phase-in process for reporting stratified
Core Set measures in Sec. 437.10(b)(7) and (d) of this final rule.
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\35\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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Comment: We received many comments making recommendations on
stratification factors for State reporting of Core Sets in Sec.
437.10(b)(7) and (d) such as:
Addition of sexual orientation and gender identity; socio-
demographic data; pregnancy status; and socioeconomic status;
Addition of the State's Medicaid expansion status with
respect to coverage of adults under age 65 who are described in 42 CFR
435.119, as well as extended coverage during the 12-month postpartum
period under section 1902(e)(16) and 2107(e)(1)(J) of the Act; and
Recommendations both for and against addition of health
care delivery system as a stratification factor. Many commenters noted
that stratification by health plan could identify trends in quality,
advance State alternative payment methodologies, and support oversight.
One commenter noted that stratification by health plan would be
especially helpful in comparing plans that are engaged in quality
improvement projects to those that are not. Other commenters suggested
that it may be helpful for certain measures to be stratified on a
multi-level basis, for example, health plan data disaggregated by race,
ethnicity, and other factors. Another commenter suggested that
stratification by delivery system be used
[[Page 60290]]
for quality improvement efforts only, and public reporting occur at the
State level. A few commenters recommended that CMS not require
stratification by health plan given the regional and population
differences served by Medicaid managed care in States unless CMS can
account for variation in geography, population, and benefits.
Response: We will take these comments into consideration when
developing annual reporting guidance, which will include stratification
factors. We are finalizing Sec. 437.10(b)(7) and (d) generally as
proposed to allow for the additional stratification by other factors as
may be specified by the Secretary and informed by annual consultation
with States and interested parties per Sec. 437.10(a)(3), which could
include stratification by health plan or other factors described
previously in this final rule. This approach provides us with
flexibility to adjust stratification requirements by factors that are
both feasible and relevant in a rapidly evolving field.
Comment: Many commenters discussed both the positives and negatives
of CMS potentially using geolocation or other types of data to impute
identification of race and ethnicity. Several commenters recommended
that CMS not use imputed data to calculate race and ethnicity data, and
instead focus efforts on improving the collection and completeness of
self-reported race and ethnicity data, and minimizing the burden of
data collection and reporting, particularly on consumers. Multiple
commenters recommended that CMS use imputed data sparingly, with some
suggesting that CMS share any imputed data with States for review prior
to publication, or not publicly report the results of stratification
based on imputed data given the lack of validity of such data.
Commenters noted it is critical that CMS provide details on what
specific imputation methods would be used to stratify the Medicaid
data, as many methods have been developed based on Medicare data and
may not yield as accurate results in the Medicaid population.
Additionally, one commenter recommended use of standardized imputation
methods across the industry.
Response: We agree that self-reported beneficiary data should be
used whenever possible, and that it is important to undertake efforts
to improve data quality. To that end, in our efforts to improve the
quality of race and ethnicity data, we have: issued guidance on
reporting race and ethnicity in Transformed Medicaid Statistical
Information System (T-MSIS); \36\ provided State technical assistance
on identifying and investigating data quality issues based on
unspecified, unknown, missing or invalid race and ethnicity data and
worked with States to improve data quality and completeness; and
published data quality assessments in the Medicaid Data Quality (DQ)
Atlas. Complete demographic information from beneficiaries is the
optimal source of data for stratification, and our development of
imputation models is intended to complement this source with a reliable
method to identify disparities in the face of missing or inaccurate
data.\37\ We will release detailed documentation about the methodology
used to develop imputations prior to the release of these data. We will
take these suggestions into consideration and will consult with States
on the use of imputed race and ethnicity when developing annual
reporting guidance, technical assistance, and other resources for
States.
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\36\ https://www.medicaid.gov/medicaid/data-and-systems/macbis/tmsis/tmsis-blog/109701.
\37\ Elliott, Marc N., et al. ``Using the Census Bureau's
surname list to improve estimates of race/ethnicity and associated
disparities.'' Health Services and Outcomes Research Methodology 9.2
(2009): 69-83.
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Comment: We received several comments about other sources of
demographic data. Several commenters recommended that CMS use
demographic data collected on the Medicaid and CHIP eligibility
application and provide guidance that covers the entire process of data
collection, reporting, and sharing. In reference to self-reported data,
one commenter suggested CMS ensure that consumers are aware of the
reasons why the data are being collected, that the process is
voluntary, that no adverse action will result for failing to provide
the data (that is, no loss of health benefits or access to services),
and of how the data may be used, shared, and disclosed. Multiple
commenters recommended that the CMS Single, Streamlined Online
Application be revised to allow beneficiaries to select a ``decline to
answer'' option in response to demographic questions. Other commenters
suggested using State administrative data to supplement missing
demographic information, and the use of electronic data in general, and
recommended that CMS provide technical assistance on how to report
measures for individuals with ``unknown'' race/ethnicity. One commenter
suggested providing detailed measure information, such as indicating
the data source or imputation methodology for demographic and
performance data.
Response: Modifications to the Single Streamlined Application and
State eligibility forms are outside the scope of this rulemaking;
however, we will take the suggestions into consideration when making
updates to the Single Streamlined Application. The Single Streamlined
Application follows the OMB data standards for collection of race and
ethnicity data, and use of this application is optional for States.\38\
When developing their own applications, States are encouraged to use
the same standards and must ensure that questions asking about race and
ethnicity are optional. The Single Streamlined Application eligibility
application available through HealthCare.gov includes the following
language alongside questions about race and ethnicity: ``Selecting this
person's race and ethnicity helps the U.S. Department of Health and
Human Services improve service to all people using the Marketplace. We
use this information to make sure everyone gets fair access to
coverage. Providing this information won't impact eligibility, plan
options, or costs.'' \39\ State Medicaid and CHIP agencies have the
flexibility to choose to include similar language in their eligibility
applications and are better positioned than CMS to collect this data
directly.\40\
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\38\ The categories for HHS data standards for race and
ethnicity are based on the disaggregation of the OMB standard:
https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=53.
\39\ Health Insurance Marketplace Application Instructions:
https://www.healthcare.gov/downloads/marketplace-application-for-family-instructions.pdf.
\40\ States could adopt this or similar language in their
application, regardless of the modality (paper, online, phone).
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Comment: Several commenters recommended that CMS acknowledge that
States with smaller and/or more homogeneous populations may not be able
to report data for a sufficient number of individuals for some
stratification categories, such that CMS will need to suppress data to
ensure privacy protections.
Response: We agree with the need to protect beneficiary privacy. We
noted in the proposed rule that we will follow data suppression
policies for measure stewards in addition to the CMS Cell Size
Suppression Policy such that if sample sizes are too small, data will
not be publicly reported to avoid a potential violation of privacy. We
are finalizing Sec. 437.10(d) generally as proposed.\41\ We plan to
provide technical assistance to
[[Page 60291]]
States as needed and will publish data suppression guidance in annual
reporting guidance.
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\41\ CMS Cell Suppression Policy: https://www.hhs.gov/guidance/document/cms-cell-suppression-policy.
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Comment: One commenter recommended establishing minimum
denominators to identify statistically significant changes in
disparities.
Response: We will take this comment into consideration for future
guidance regarding health disparity analysis.
Comment: Some commenters suggested methods for CMS to align with
other measure sets and organizations. Several commenters requested that
CMS align with NCQA HEDIS as much as possible, including stratification
categories and age ranges, and that other stratification factors be
phased in after race and ethnicity. One commenter recommended that CMS
explore using data submitted to NCQA for accreditation to ease burden
on providers, plans, and States. Another commenter recommended that CMS
encourage States to use the NCQA Electronic Clinical Data System (ECDS)
reporting method for applicable measures. One commenter suggested the
Federal government streamline efforts and standardize measures sets
across all payers, and that CMS, Health Resources and Services
Administration (HRSA), and HHS provide available data when possible to
reduce burden to States and providers. Another commenter suggested CMS
explore opportunities to get a broader view of child health by
connecting different Federal databases, including those that collect
data for Title V, public health, child welfare and children's mental
health programs, and encourage these same connections at the State
level.
Response: We will take these ideas into consideration when
developing annual reporting guidance. We agree with the commenters on
the importance of parsimony, alignment, and harmonization in quality
measurement to the extent possible. Throughout the annual Core Set
review process, we actively engage with a variety of internal and
external interested parties, Federal partners, other reporting agencies
related to Medicaid and CHIP, and Medicare and Marketplace. This
process facilitates measure alignment as appropriate, noting areas of
needed divergence due to differences in reporting levels.
Comment: Several commenters recommended that CMS work with other
Federal agencies on Fast Healthcare Interoperability Resources (FHIR)
application programming interfaces (API) standards, stating that
aligning with FHIR standards would resolve many of the challenges in
accessing both administrative and clinical data required to report Core
Set measures, including demographic data required for stratification.
These commenters encouraged CMS to explore ways to leverage the current
interoperability and information sharing regulations to promote data
sharing across systems and minimize the reporting burden on consumers.
One commenter recommended that CMS undertake an assessment of the
barriers and opportunities to enable data exchange and information
systems interoperability in order to help report outcomes-based
measures. Another commenter noted that simply relying on Electronic
Health Record (EHR) vendors to implement FHIR and United States Core
Data for Interoperability (USCDI) standards will not be enough to
ensure complete and accurate data. One commenter noted challenges with
sharing data across systems with different EHRs. Several commenters
expressed concern about data entry errors creating an increased State
burden and recommended that CMS consider technical interventions such
as open-source tools or use of structured electronic data files,
standardized spreadsheets, API or other upload options to reduce burden
and errors created through manual data entry.
Response: We will take these comments into consideration when
developing annual reporting guidance, technical assistance, and other
resources for States.
D. Annual Reporting on the Child, Adult, and Health Home Core Sets
As discussed in section II.D. of the proposed rule, we proposed in
Sec. Sec. 437.10 and 437.15 the key requirements and procedures for
States in reporting both mandatory and voluntary measures, including
the procedures to identify measures that States would report, measures
that we would report on behalf of States, and measures for which States
may elect to have us report on their behalf. We also solicited comments
on what technical assistance we should provide to support these
activities.
We received public comments on the process proposed in Sec. Sec.
437.10 and 437.15, and in general, commenters supported the proposed
process. We are finalizing these provisions with revisions to
Sec. Sec. 437.10 and 437.15. We describe in section II.D.2. of this
final rule our revisions to Sec. Sec. 437.10 and 437.15 regarding
reporting of mandatory measures, in addition to a revision regarding
survey-based measures in Sec. 437.10(b)(1)(v). We describe in section
II.D.3. of this final rule our revisions to Sec. Sec. 437.10 and
437.15 regarding populations required for mandatory reporting. Below is
a summary of the public comments we received regarding this section and
our responses.
Comment: Several commenters recommended that CMS allow States the
option to self-report; or allow other alternate data sources such as
Transformed Medicaid Statistical Information System (T-MSIS) Analytic
Files (TAF) to be used to calculate measures on States' behalf.
However, these and other commenters requested additional information on
the use of T-MSIS/TAF and noted that alternate data sources should be
used only under certain conditions, namely: that States are allowed to
opt-out; that States are provided the opportunity to review and confirm
results; and that the calculation methodology adheres to the measure
specifications including use of denied claims, among other
stipulations. One commenter also requested that CMS provide States with
assistance in investigating data discrepancies or measurements that
seem to be in error.
Response: We will continue to assess whether T-MSIS/TAF or other
alternate data sources can be used to calculate Core Set measures on
behalf of States. As stated in Sec. 437.10(b)(1)(iv), we will continue
to calculate selected measures on States' behalf using alternative data
sources and, in these cases, we anticipate providing States with an
opportunity to preview data. For other selected measures, as stated in
Sec. 437.10(b)(1)(iv), we will allow States the option to either self-
report (if they adhere to CMS-issued reporting guidance as per Sec.
437.15(a)(3)), or allow the measures to be calculated on States' behalf
using alternate data sources. We currently provide States an
opportunity to preview data for any measure calculated utilizing
alternate data sources such as ``Live Births Weighing Less Than 2,500
Grams'' on the Child Core Set and ``National Core Indicators Survey''
on the Adult Core Set and intend to continue doing so. We are
finalizing Sec. Sec. 437.10(b)(1)(iv) as proposed and Sec.
437.15(a)(3) with a minor wording change.
Comment: Several commenters raised concerns with the use of T-MSIS/
TAF data to calculate Core Set data or for stratification, as there may
be issues with the data validity for many States, and recommended that
CMS not use T-MSIS for reporting on behalf of States. For example, some
measures may require more years of data than are available through T-
MSIS, or data reported through T-MSIS may be incomplete.
Response: We assess each Core Set measure individually to determine
if it is able to be calculated using T-MSIS/
[[Page 60292]]
TAF data, based on the technical specifications, considering the years
of data available in T-MSIS and also the types of data required to
accurately calculate that measure. As stated previously in this final
rule preamble, we also intend to allow States to preview all Core Set
data generated by T-MSIS.
Comment: One commenter recommended that CMS develop a third-party
validation process that certifies State measure logic and audits
Information Technology (IT)/measurement systems in a standardized way.
This commenter also suggested validating supplemental data from the
source, providing the example of NCQA's Data Aggregatory Validation
program. Another commenter recommended that CMS test and validate
stratified results to ensure they are accurate.
Response: We agree with the commenter on the importance of data
quality in Core Set reporting. We have built a pre-publication quality
assurance process into the review of all Core Sets data. Through this
process, we work with States to resolve data quality issues and confirm
any deviations from the reporting guidance. Sections 1139A and 1139B of
the Act require the Secretary to collect, analyze, and make publicly
available the information reported by States; however, these sections
do not require the levels of data validation recommended by these
commenters. While sections 1945(g) and 1945A(g) of the Act give the
Secretary the authority to establish requirements related to the form
and manner of health home quality reporting, they do not specify that
the Secretary must require data validation of submissions. We will
continue to evaluate data validation needs in developing resources for
Core Set reporting.
Comment: One commenter recommended that CMS maximize the use of
performance data that can be collected and transmitted electronically,
and to minimize manual data collection. We understand the commenter to
be recommending that the measures on the Core Sets primarily be those
that can be calculated using only administrative or EHR data versus
those that require manual chart reviews or in-person surveys.
Response: We appreciate the submission of these comments and will
take this feedback into consideration in the subregulatory measure
review process.
Comment: One commenter noted that if Health Homes are required to
report to the State, each Health Home will require extensive technical
assistance, funding for technical assistance and result validation,
expertise in quality measure specifications, and staff. Some commenters
noted that Health Home programs and their providers of Care Management
do not have reliable, current, and consistent access to claims,
encounter, and clinical data to effectively report on these measures.
They further stated that Health Home care management is not itself a
clinical protocol model of care management, but rather a set of care
management practices that facilitate clinical care, address social care
needs, provide education, increase member health literacy, and address
health equity and disparities to improve health outcomes, all of which
makes it challenging to report on the Health Home Core Sets.
Response: This final rule implements statutory reporting
requirements for providers of section 1945 and section 1945A health
home services at sections 1945(g) and 1945A(g)(1)(B) of the Act.
Providers of section 1945 health home services are required to meet the
reporting requirements specified at section 1945(g) of the Act, and
providers of section 1945A health home services are required to meet
reporting requirements specified at section 1945A(g)(1)(B) of the Act.
If a Health Home provider is submitting data into a State-based system
that the State is then using to calculate and report the Health Home
Core Sets measures to us, those data submissions from the provider to
the State would satisfy the statutory requirements under sections
1945(g) and 1945A(g)(1)(B) of the Act. Comprehensive care management
services are not a set protocol but rather one of the six services
included in both the section 1945 and section 1945A Health Home
benefits, as specified at sections 1945(h)(4)(B)(i) and
1945A(i)(4)(B)(i) of the Act. We have provided additional information
about how we interpret this component of the section 1945 benefit in
frequently asked questions (FAQs).\42\ Health Home quality measure
reporting has always been mandatory for participating providers under
both sections 1945 and 1945A of the Act (even if using CMS' recommended
measures has not been mandatory), and health home providers will need
to coordinate with the State Medicaid Agency to seek assistance with
Core Set reporting. We understood the comment to express the belief
that the Health Home Core Set measures will be challenging to report,
because the health home model does not provide direct, clinical care
services to patients. This health home benefit is designed to be a care
coordination model, and we recognize that implementing a service model
that is separate from the provision of direct, clinical care services
to patients may be a shift for some providers and States from models
that provide direct, clinical care services, and that data sources may
be different between the two types of models. We are available to
provide technical assistance to States to navigate any challenges they
may have when reporting Health Home Core Sets, and as such, we do not
believe the reporting burden on States and providers is
unreasonable.\43\
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\42\ Health Home FAQs (January 21, 2016), https://www.medicaid.gov/sites/default/files/2020-02/health-homes-section-2703-faq.pdf.
\43\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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Comment: One commenter recommended allowing a minimum of 18 months
to develop, test, and deploy new reporting requirements from a health
IT standpoint once a State provides technical specifications to
developers. Another commenter proposed that CMS consider that whenever
multiple mandatory hybrid and survey measures are introduced in 1 year,
staffing constraints, contractual agreements, procurement cycles, and
similar issues may have an impact on States' abilities to gather data
and calculate rates.
Response: We will take these comments into consideration when
determining additions to the Core Sets for mandatory reporting.
Comment: One commenter requested that we explain whether the
reporting requirements would increase the reporting burden on States
and would not increase the burden on Indian Health Service (IHS) or
Tribal facilities. They further recommended that if there was a
reporting burden on IHS or Tribes and Tribal Organizations that CMS
provide the same technical assistance to Tribes as it provides to
States.
Response: We will provide States with technical assistance \44\
related to Core Set reporting and will encourage States to work with
Tribes and Tribal Organizations to improve data sharing. We recognize
that States and Tribes establish individual contractual agreements that
might affect the availability of Tribal data for Core Sets reporting.
Given the different responsibilities for reporting that States and
health care providers (such as those operated by IHS, Tribes, and
Tribal Organizations) will have and the
[[Page 60293]]
differences in resources available to them, it is hard to gauge for
whom the burden of reporting will be greater or lesser. States should
undertake Tribal Consultation related to reporting of Core Set
measures, and are encouraged to coordinate with IHS, Tribes, and Tribal
Organizations, to support data sharing.
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\44\ About the Medicaid and CHIP Core Set Technical Assistance
and Analytic Support Program: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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Comment: One commenter noted a need for technical assistance
incorporating States' Immunization Registry into their data warehouse,
with tasks such as mapping individuals from the registry against
Medicaid members and identifying the percent match rate. This commenter
also stated that their State may need assistance with including CHIP
enrollees' birth and mortality records from the State's Vital
Statistics Office into their Medicaid and CHIP data warehouse.
Response: We will take this feedback into consideration when
developing technical assistance resources and reporting guidance for
Core Set reporting.
Comment: Multiple commenters recommended that CMS continue to offer
technical assistance using a variety of formats including written
guidance, standard templates, FAQs, measure specification and coding
assistance, sharing of best practices, one-on-one State-specific
technical assistance, learning collaboratives, direct communication
with the technical assistance contractor, and instructional webinars
that allow for questions. Commenters noted these have been effective
mechanisms and will be needed in the future to meet mandatory reporting
requirements. One commenter recommended templates and examples as part
of technical assistance, while another recommended further
clarification, structuring, and additional details in the reporting
guidance to help streamline reporting and reduce error, but also to
help States conduct quality assurance for their results. Additionally,
several commenters requested technical assistance on data sharing with
Federal and commercial partners, data stratification requirements, and
how to address data limitations such as small sample sizes.
Response: We thank the commenters for their feedback on technical
assistance methods and needs. We will provide technical assistance and
will consider the suggestions when developing future technical
assistance resources.
1. Adherence to Reporting Guidance
As discussed in section II.D.1. of the proposed rule, we proposed
in Sec. 437.15(a)(3) to require States to report on the Core Sets in a
manner that adheres to CMS-issued reporting guidance described in Sec.
437.10(b), which we proposed would include procedures and standardized
formats for reporting measure data.
In general, commenters supported these proposals, and we are not
making any changes to them in response to these comments. Below is a
summary of the public comments we received regarding specific
components of these proposals and our responses.
Comment: Multiple commenters concurred with CMS requiring States to
adhere to the annual reporting guidelines to enable comparisons across
States on quality performance and to calculate national performance
rates for quality of care. Other commenters noted that standardized
reporting should be the minimum requirement, and expectations for
reporting should increase over time.
Response: We agree that requiring States to adhere to the reporting
guidance, which we are finalizing in Sec. 437.15(a)(3), is essential
to provide effective comparisons across States on quality measure
performance and to derive national performance rates for the care
provided to Medicaid and CHIP beneficiaries. We also recognize that
adherence to CMS-issued reporting guidance as described would be a
substantial change from current reporting for some States. Recognizing
the challenges that States may face in reporting stratified measure
data and data for certain populations, we are finalizing in this
rulemaking a phase-in approach for both the required stratification in
Sec. 437.10(d) and the reporting for certain populations in Sec.
437.10(c), with stratified reporting of all mandatory measures required
in the fifth year of annual reporting after the effective date of part
437 of this final rule.
Comment: Multiple commenters expressed concerns regarding strict
adherence to reporting guidance as some deviations are the result of
underlying differences in how State Medicaid programs or their data
systems are structured. For example, some States limit the number of
diagnosis codes that MCOs can submit, which may result in an eligible
beneficiary being excluded from, for example, a diabetes measure if
diabetes was not one of the highest diagnosis codes submitted for a
visit in which multiple conditions were addressed. Another commenter
requested that allowances be made for States to use the most reliable
data source available, stating for example, the use of birth/vital
records data vs. claims data for pregnancy/birth-related measures
provides more specific information than can be found in claims data
alone. One commenter proposed that if adherence is required, States
should be permitted to explain any underlying systems differences that
result in un-representative rates, and CMS should include this
information with public reporting.
Response: Adherence to the reporting guidance is essential to
provide effective comparisons across States on standardized quality
measure performance and to derive national performance rates for the
care provided to Medicaid and CHIP beneficiaries. As such, we are
finalizing Sec. 437.15(a)(3) to require that States adhere to
reporting guidance issued by CMS. We will provide technical assistance
to States to support their ability to do so.
Comment: Several commenters requested that reporting guidance
address the level of data completeness required to ensure that the
stratified rate would be considered valid. Another commenter
recommended that technical assistance be focused first on improving
data quality.
Response: We will take these ideas into consideration when
developing technical assistance resources and reporting guidance for
Core Set reporting.
Comment: Several commenters requested that CMS reporting guidance
for the Core Sets be identical to the measure developers'
specifications to allow organizations to report measures used in
multiple programs consistently. Several commenters made this
recommendation specifically due to the burden associated with reporting
measures that deviate from NCQA HEDIS specifications, while others also
recommended this approach specifically if deviation from CMS guidance
is no longer permitted. One commenter also recommended that CMS
continue allowing States to report using audited MCO NCQA HEDIS rates.
Response: We will consider these comments when developing reporting
guidance. Core Set reporting is State-level or health home program-
level reporting, while NCQA HEDIS is plan-level reporting, and
therefore, measure adaptations are necessary for us to provide guidance
to States for State- or Health Home program-level reporting. In making
measure adaptations, we work closely with measure stewards, including
NCQA, to develop reporting guidance and to make as few adaptations to
the technical specifications as possible. Such adjustments generally
are limited to adjusting the age ranges of a measure to align with
either the Child or Adult Core Sets.
[[Page 60294]]
Comment: One commenter encouraged CMS to be mindful of
implementation timelines, which may overlap with States' work related
to the restoration of eligibility and enrollment operations, including
terminations of enrollment, following the end of the continuous
enrollment condition under section 6008(b)(3) of the Families First
Coronavirus Response Act, as amended by the CAA, 2023, a process
referred to as ``unwinding.''
Response: The timeline for mandatory reporting was statutorily
established in 2018 to implement mandatory annual reporting of the
Child Core Set and the behavioral health measures on the Adult Core
Set, and these statutes do not include any provisions allowing us to
modify the implementation timeline. We interpret the language in the
Bipartisan Budget Act of 2018 and the SUPPORT Act to mandate annual
reporting of these Core Sets beginning with the annual State report on
FFY 2024 and align with State reporting of the 2024 Core Sets,
currently projected to occur in Fall 2024. However, consistent with
Sec. 437.10(c) and (d), to minimize State burden, we plan to phase in
requirements for measure stratification and Child and Adult Core Sets
reporting for populations for which States do not have data access.
2. Reporting of Mandatory Measures
As discussed in section II.D.2. of the proposed rule, we proposed a
methodology to phase in reporting of certain measures, including those
that may be complex or difficult to report, those that are newly added
to the Core Sets, or those that had significant updates to technical
specifications from the prior year. We also asked for comment on how
best to phase in reporting, the optimal frequency for reporting of
outcome and survey-based measures, technical assistance States may
need, and promising practices and approaches for data collection and
data linkages.
We received comments stating that the Secretary does not have the
statutory authority to delay the reporting of selected measures for any
of the Core Sets, in addition to many comments supporting the proposed
phased-in reporting process for mandatory measures. Upon additional
review, we have determined that all of the measures currently on the
Child Core Set and all of the behavioral health measures on the Adult
Core Set should be subject to mandatory reporting in 2024. The majority
of the measures proposed for the initial mandatory measure set for
these Core Sets can be calculated using administrative data and have
been on these Core Sets for many years, specifically, a median of 7
years for the Child Core Set and 10 years for the behavioral health
measures on the Adult Core Set. Based on this analysis, and the fact
that we have already released the list of measures included in the 2024
Child and Adult Core Sets,\45\ allowing States significant time to
prepare to report on these measures, we believe that all measures on
the 2024 Child Core Set and all behavioral health measures on the 2024
Adult Core Set can be reported by States and, in this final rulemaking,
are requiring that States report on all of them.
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\45\ CMS released both the 2023 and 2024 Child and Adult Core
Sets in November 2022 and the 2023 and 2024 section 1945 Health Home
Core Set in December 2022.
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We have similarly determined that States and health home providers
must report on all measures in the section 1945 and/or 1945A Health
Home Core Sets, to better inform CMS evaluations of these health home
programs and help us to analyze health home measures. Section 1945(g)
of the Act specifies that, as a condition for receiving payment for
section 1945 health home services, a health home provider shall report
to the State, in accordance with such requirements as the Secretary
shall specify, on all applicable measures for determining the quality
of such services. Section 1945A(g)(1)(B) of the Act states that to
receive payments for section 1945A health home services from the State
a health home provider shall report to the State information on all
applicable measures for determining the quality of health home services
provided by such provider, including, to the extent applicable, child
health quality measures and measures for centers of excellence for
children with complex needs developed under title XIX, title XXI, and
section 1139A of the Act. Additionally, section 1945A(g)(1)(C) of the
Act requires section 1945A health home providers to report to the State
such other information as the Secretary shall specify in guidance. In
sum, both health home program statutes require health home providers to
report to States on all applicable health home quality measures and
give the Secretary discretion to identify the measures required for
reporting each year. Since the inception of the section 1945 health
home benefit, we have strongly encouraged States implementing that
benefit to report on all applicable Health Home Core Set measures
specified by the Secretary, and most have done so. Although prior to
this rule, Health Home Core Set reporting has not been mandatory, we
have no indication that States currently reporting the section 1945
Health Home Core Set measures have faced major burdens in doing so, and
100 percent of the current section 1945 Health Home Core Set measures
can be reported using administrative claims only. When selecting
measures to add to the Health Home Core Sets, we have been careful to
ensure States and providers are able to report on all selected
measures, and to ensure that the data provided when reporting on the
measure would be useful for monitoring program performance and the
quality of services provided to beneficiaries enrolled in the health
home program. Based on the high rate of voluntary health home measure
submission thus far, and the careful consideration we have given to
measure selection, it is reasonable for CMS to expect States to comply
with mandatory reporting for all measures on both of the Health Home
Core Sets in the future. Additionally, since both sections 1945 and
1945A state that health home providers are statutorily required to
report to the State as a condition of payment, States should have these
data readily available for reporting to us. Finally, reporting of all
measures on the Health Home Core Sets would inform CMS evaluation of
both health home programs, assist us to identify racial, socioeconomic
and geographical disparities in health outcomes, and inform future
quality-related decisions about national policy for Medicaid health
home programs by providing more uniform national data. Therefore, via
this rule, we are mandating that both States and health home providers
report on all Health Home Core sets measures, consistent with the
Secretary's authority under sections 1945, 1945A, and 1902(a)(6) of the
Act.
We therefore are revising the final rule as it pertains to the
Child, Adult, and Health Home Core Sets as follows. We are removing
proposed Sec. 437.10(b)(1)(v), which provided States with additional
time to report selected measures. We are replacing that proposed
paragraph, in response to public comment, with language specifying that
the frequency of reporting survey-based measures will be no more than
annual. Additionally, we are revising Sec. 437.10(c) to remove
reference to phasing in measures and adding Sec. 437.15(a)(1)(i) to
require reporting on all measures in the 2024 Child Core Set and the
behavioral health measures in the Adult Core Set. Mandatory reporting
of the Health Home Core Sets is required only for an approved health
home SPA that has an
[[Page 60295]]
effective date and has been implemented more than 6 months prior to the
December 31st reporting deadline. This means that, for the States with
approved health home program 1945 SPAs that were effective and
implemented prior to June 30, 2023, the section 1945 Health Home Core
Set would become mandatory in 2024. For both 1945 and 1945A SPAs that
were effective and implemented starting July 1, 2023 through June 30,
2024, reporting the section 1945 and 1945A Core Set(s) would become
mandatory in 2025.
Future new mandatory measures will be added to the Core Sets
through the subregulatory process described in this rule. Below is a
summary of the public comments we received regarding this section and
our responses.
Comment: Several commenters recommended that all States be required
to report all Child and Adult Core Sets quality measures, as specified
in statute at sections 1139A(a)(4)(B) and 1139B(b)(3)(B) of the Act, in
the 2024 reporting year. Many commenters stated that they did not agree
that the Secretary has the statutory authority to delay the reporting
of selected measures for any of the Core Sets. One commenter
recommended that mandatory State reporting should be required for all
Child and Adult Core Sets required in statute, but that CMS could
create an exceptions process for States that demonstrated that the
requirement would generate unreliable data. This commenter requested
that CMS ensure that States operating under such an exception report at
least a standardized minimum set of measures to ensure valid
comparisons across all States.
Response: Upon additional review, we agree that all of the measures
on the Child Core Set and the behavioral health measures on the Adult
Core Set should be subject to mandatory reporting in 2024, consistent
with sections 1139A(a)(4)(B) and 1139B(b)(3)(B) of the Act.
Comment: Some commenters supported a phased-in approach to the
inclusion of measures in mandatory reporting. One commenter recommended
that CMS collect feedback from impacted interested parties on the most
feasible reporting timeframe for specific measures while another
recommended that States be allowed at least 2 years to begin reporting
on new measures. One commenter recommended that the ``Screening for
Depression and Follow-up Plan'' measure that is on both the Child and
Adult Core Sets be required no earlier than the 2026 Core Sets. Another
commenter recommended that CMS begin mandatory reporting of outcome
measures using measures that only require administrative data and do
not require supplementary data from other sources. Other commenters
suggested several years of optional reporting for outcome and survey
measures, and for measures that require EHR data.
Response: Upon additional review, we have determined that the
statute requires that all of the measures on the Child Core Set and the
behavioral health measures on the Adult Core Set should be subject to
mandatory reporting in 2024. We recognize that some types of data
collection are more burdensome than others, and States often struggle
with collecting data for measures that depend on non-claims sources,
hybrid specifications, or EHRs. We will provide technical assistance
including one-on-one support to assist States with mandatory
measures.\46\ The outcomes of this process would be published in annual
subregulatory guidance, as finalized in Sec. 437.10(b) and (c) of this
final rule.
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\46\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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Comment: One commenter recommended allowing States flexibility to
determine the approach for hybrid- and survey-based measures based on
their delivery system and not limiting reporting to one survey type,
noting that a survey from an MCO that only serves beneficiaries with
serious mental illness would not be comparable to other survey
populations.
Response: We appreciate that there is considerable variability
between States in how populations are served within their delivery
systems and programs and how these populations are represented in
State-level and health home program-level reporting. Despite these
differences we believe the use of standardized quality measures,
reporting guidance, and reporting is needed to accurately assess and
compare data across populations and time and to allow for
identification of more specific quality improvement opportunities. Use
of alternative measures or survey types would undermine this goal.
Therefore, we are not making any changes to Sec. 437.10(b) in response
to this comment.
Comment: Several commenters made recommendations regarding the
survey-based measures in the Child and Adult Core Sets, such as those
based on the CAHPS survey. A few commenters recommended that CMS
require States to report data biennially (that is, once every 2 years)
for all health outcome and survey-based measures. However, one
commenter stated that they preferred annual reporting due to the loss
of measure consistency, need to monitor quality improvement projects,
and staffing and training issues. One commenter recommended that CMS
consider the impact of declining response rates to surveys on Core Set
reporting, and avoid duplicating efforts, noting that MCOs are also
required to conduct CAHPS surveys. Some commenters encouraged CMS to
explore alternative patient experience measures before phasing-in
mandatory reporting of CAHPS-based measures.
Response: We intend to require annual reporting of health outcome
and survey-based measures, which aligns with CHIP reporting
requirements in section 2108(e) of the Act, as implemented through
section 402 of CHIPRA. Specifically, Title XXI programs are required to
annually submit to CMS data regarding access to primary and specialty
services, access to networks of care, and care coordination provided
under the State child health plan, using quality of care and consumer
satisfaction measures included in the CAHPS survey. However, we
appreciate the concerns raised regarding barriers to annual reporting
of these measures and believe it is important for us to have the
flexibility to reconsider frequency as needed based on State feedback.
Therefore, we have revised Sec. 437.10 to replace paragraph (b)(1)(v),
which now specifies that survey-based measures will be required no more
frequently than annually, allowing flexibility to respond to State
needs in the future.
3. Populations Required for Mandatory Reporting
In section II.D.3. of the proposed rule, we explained that we
interpret sections 1139A and 1139B of the Act to require that reporting
for the Child Core Set include all beneficiaries covered by Medicaid
and CHIP and to require that reporting for the behavioral health
measures in the Adult Core Sets include all beneficiaries covered by
Medicaid. We further explained that this would include beneficiaries
enrolled in all Medicaid and CHIP delivery systems as well as services
received in all applicable health care settings, such as hospitals,
outpatient settings, Federally Qualified Health Centers (FQHCs), rural
health clinics (RHCs), and facilities operated by IHS, by Tribes and
Tribal Organizations under the Indian Self-Determination and Education
Assistance Act, and by Urban Indian Organizations under Title V of the
Indian Health Care Improvement Act.
[[Page 60296]]
We also explained in section II.D.3. of the proposed rule that
sections 1945(g), 1945(c)(4)(B), 1945A(g)(1)(B), and 1945(g)(2)(A)(i)
of the Act, together with section 1902(a)(6) of the Act, support CMS
guidance requiring State reporting on the Health Home Core Sets to
include all beneficiaries enrolled in the applicable health home
program. We further explained that this would include health home
program beneficiaries receiving services through all Medicaid delivery
systems, as well as health home program beneficiaries who received
Medicaid-covered services in all applicable health care settings, such
as hospitals, outpatient settings, FQHCs, RHCs, and facilities operated
by IHS, Tribes and Tribal Organizations, and Urban Indian
Organizations, during the measurement period. Further, we explained
that we anticipated that health home programs would have to report on
beneficiaries who have received Medicaid-covered health home services
in FQHCs, RHCs, and facilities operated by IHS, Tribes and Tribal
Organizations, and Urban Indian Organizations only if a beneficiary who
is enrolled in the applicable health home program received Medicaid-
covered health home services in one of these settings during the
measurement period.
As explained in the proposed rule, we ultimately expected to
require States to report on the populations discussed previously in
this final rule for each Core Set through the annual reporting
guidance; however, we did not propose to require this to begin with
2024 Core Set reporting in light of concerns about whether it would be
feasible for States to begin reporting on all populations as soon as
the rule would apply. Therefore, we proposed that the Secretary could,
through the annual reporting guidance, phase in reporting on certain
populations. Specifically, we proposed at Sec. 437.10(b)(5) that
annual reporting guidance would identify those populations for which
States would be required to report measure data for a given year, and
also proposed at Sec. 437.10(c) that this annual guidance might
provide that mandatory State reporting for certain populations of
beneficiaries would be phased in over a specified period of time. These
proposals applied to all Core Set reporting: Child, Adult, and Health
Home. We solicited comment on how best to provide technical assistance
to support States in reporting on all populations as well as on how
long States may need to be able to report on all Medicaid, CHIP, and
Health Home program beneficiary populations.
Comment: We received several comments supporting full mandatory
reporting for all populations. However, many comments about these
proposals noted concerns and challenges with reporting for specific
populations of beneficiaries, such as those who are dually eligible for
Medicare and Medicaid; those whose Medicaid or CHIP coverage is limited
to payment of premiums and/or cost sharing, which may include those
with private insurance; and those who receive services through Tribes
and Tribal Organizations. We also received comments encouraging CMS to
consider allowing States the ability to identify specific populations
where reporting is difficult due to unique State circumstances.
Response: Although the majority of comments addressed concerns with
including specific discrete populations in reporting of the Child and
Adult Core Sets, we continue to believe that the intention of the
statute is to provide the most comprehensive quality information on as
much of the population as possible. Our view is that Congress'
requirement for a mandatory reporting regime emphasizes their intent to
ensure that all Medicaid and CHIP populations are aware of the quality
of care in their state. Therefore, we have revised Sec. 437.15(a)(4)
of this final rule to require State reporting of mandatory Child and
Adult Core Set measures for all Medicaid and CHIP beneficiaries,
including those enrolled in fee-for-service and managed care, unless
the Secretary specifies in annual guidance that the population is not
required to be reported in accordance with Sec. 437.10(b)(5) or CMS
grants a State exemption for the population for one or more Child or
Adult Core Set measures in accordance with Sec. 437.15(a) of this
rule. This differs somewhat in approach from the proposed rule, in
which subregulatory guidance would identify populations for which
States would be required to report; however, the final rule provisions
are generally consistent with those commenters who supported
comprehensive reporting of quality information for all Medicaid and
CHIP populations, and with the proposed rule preamble's discussion of
the proposed policy for the Child and Adult Core Sets. Rather than
using subregulatory guidance to identify the populations for which
States must report the Child and Adult Core Sets, as we proposed, we
will instead use the guidance to identify specific difficult-to-report
populations which will be, for a given reporting year, optional for
states to include in reporting of the Child and Adult Core Sets.
With respect to the Health Home Core Sets, for the following
reasons, we have determined that States with section 1945 or 1945A
health home programs must report on all beneficiaries enrolled in the
applicable health home program or programs, with no exceptions.
Reporting on all populations served in health home programs will
provide us with more accurate and comprehensive data that will help
inform us of the effect of the health home benefits on coordination of
care and aid us in identifying ethnic, racial and socioeconomic
disparities. Also, reporting on all beneficiaries allows improved
analysis of the quality of services rendered to persons enrolled in
health home programs; such reporting can be utilized as a tool for the
Annual Core Set Measures Workgroup when evaluating how a measure is
contributing to the overall CMS mission of quality improvement for all
populations served. Additionally, States will have Health Home Core Set
measure data on all populations enrolled in the applicable health home
from their health home providers, which are required to provide it to
the State as a condition of payment under sections 1945(g) and 1945A(g)
of the Act. Since the requirement for providers to report the data
collected at the program level to States has been in effect from the
beginning of both benefits, most states that have implemented the 1945
health home benefit have been voluntarily reporting on the health home
core set for all populations. The 1945A health home benefit has not
been in effect long enough to have data on a reporting cycle.
Additionally, the population enrolled in health home programs is
usually small and easily identifiable through existing data collected
at the program level. Therefore, we have added Sec. 437.15(a)(5) to
the final rule, to require State reporting of sections 1945 and 1945A
Health Home Core Sets measures for all beneficiaries enrolled in an
approved health home program. This includes those beneficiaries that
received Medicaid-covered health home services in FQHCs, RHCs, and
facilities operated by IHS, Tribes and Tribal Organizations, and Urban
Indian Organizations, if the beneficiary who is enrolled in the
applicable health home program received Medicaid-covered health home
services in one of these settings during the measurement period.
Because reporting on the Health Home Core Sets is required for all
beneficiaries enrolled in an approved health home
[[Page 60297]]
program, we also have revised Sec. 437.10(b)(5) and (c) of this final
rule to specifically reference only the Child and Adult Core Sets. The
revisions to Sec. 437.10(b)(5) required us to remove the wording, ``as
described in paragraph (b)(5) of this section'' from Sec. 437.10(b)(6)
as annual reporting guidance on attribution rules applies to the Child,
Adult, and Health Home Core Sets.
We address concerns about the feasibility of Child and Adult Core
Sets reporting for specific populations in the final rule in two ways.
First, because we recognize that there are certain populations for
which all States potentially face difficulties in obtaining data, we
are revising Sec. 437.10(b)(5) and (c) of this final rule to provide
that we will use the annual subregulatory guidance to identify specific
populations which will be optional (that is, not mandatory) for States
to include in reporting of the Child and Adult Core Sets for a given
reporting year. For example, all States that commented on the proposed
rule (including those States that currently participate in the
Medicare-Medicaid Data Sharing program) requested more time to obtain,
link, and analyze Medicare FFS claims and Part D events data. Further,
States do not have access to the Medicare Part C data required to
report on dually eligible beneficiaries who have enrolled in Medicare
Advantage. Given these concerns with data access and experience, this
could be an example of a population that the Secretary may exempt in
subregulatory guidance issued prior to mandatory reporting. We note
that these data access concerns do not impact the States' ability to
report on Health Home Core Set measures since these measures do not
require Medicare data. As stated previously, States will have Health
Home Core Sets measure data on all populations enrolled in the
applicable health home from their health home providers, which are
required to provide it to the State as a condition of payment under
sections 1945(g) and 1945A(g) of the Act. In addition, all the measures
in the 2023 and 2024 section 1945 Health Home Core Set as well as all
of the measures under consideration for the section 1945A Health Home
Core Set can be reported using administrative claims data. Therefore,
reporting on all populations for the Health Home Core Sets should not
pose an excessive burden on States in the absence of any exceptions.
Second, as set forth in Sec. Sec. 437.10(b)(5)(i) and 437.15(a)(4)
and (6) of this final rule, we allow States to request a 1-year
exemption from reporting for specific populations for one or more Child
and/or Adult Core Set measures where those populations have not already
been exempted by the Secretary for that year in the annual
subregulatory guidance. The State would be eligible for such a 1-year
exemption if it demonstrates to CMS that, despite reasonable efforts,
it is not able to obtain access to data required to report for the
population; for example, that it is unable to obtain needed third party
data or to finalize a necessary data-sharing agreement between parties
before the reporting deadline. The State must request the exemption
from us by September 1st of the applicable reporting year, the
exemption would be only for that year's reporting, and it would apply
only to the specific population for which the State receives an
exemption. We do not expect that this population-based exemption
process will create an avenue for states to request an exemption from
reporting one or more measure(s) in their entirety as most states are
already reporting the majority of Core Sets measures for most of the
beneficiaries in Medicaid and CHIP. The State will be required to
explain why this exemption is necessary and provide a reasonable
timeline of the actions underway to resolve the data access issue. In
addition, as previously stated in this final rule, the State must
demonstrate to us that it has made a reasonable effort to obtain the
required data by the reporting deadline. We plan to respond to the
State's request before the close of the mandatory reporting period to
ensure that the State has time to complete reporting by December 31st.
If we deny a State's request for exemption, the State will be expected
to include the relevant population in that year's annual Child and
Adult Core Sets reporting. Additionally, a State may re-apply in
subsequent years to extend an exemption that has been granted. As
stated in Sec. 437.10(b)(5)(i), annual subregulatory guidance will
provide information about how States can request an exemption.
Below is a summary of the public comments we received regarding
this section and our responses.
Comment: Several commenters supported the requirement that States
include populations that are harder to report in Core Set reporting, as
outlined in the proposed rule, including those who are dually eligible
for Medicare and Medicaid, those who use long-term services and
supports, people with substance use disorders, and people in FFS
Medicaid, including in States that enroll most people in managed care.
Response: We thank these commenters for their support of required
reporting for these populations.
Comment: Multiple commenters requested additional clarification
from CMS on how States should allocate beneficiaries who experience
gaps in coverage or who are enrolled in multiple plans during the
reporting period. Specifically, in some States, commenters noted that
FFS enrollment is temporary until a beneficiary selects a managed care
plan. In other States, FFS populations may comprise a very small
percentage of total Medicaid enrollment. The commenters recommended
that CMS consider whether the inclusion of the beneficiaries
temporarily enrolled in FFS in Core Set reporting is an appropriate use
of significant State resources.
Response: As discussed in section II.D.3. of this final rule, we
interpret sections 1139A and 1139B of the Act to require reporting of
all beneficiaries covered by Medicaid and CHIP for the Child Core Set,
and to require reporting for the behavioral health measures in the
Adult Core Set of all beneficiaries covered by Medicaid. Additionally,
as discussed previously in this section of this final rule, we are
requiring in this final rule that reporting for the Health Home Core
Sets include all beneficiaries enrolled in the applicable health home
program. Attribution of performance and quality data poses challenges
for the health care field, and Medicaid and CHIP in particular, as it
requires striking a balance between the person-centered goal of
measuring quality of care for a beneficiary regardless of delivery
system and feasibility for providers, plans, health systems, and
States. Our intent in implementing mandatory reporting requirements is
for the data collected to be as inclusive of all beneficiaries as
possible. However, when developing annual guidance, we will consider
what distinctions between delivery systems are meaningful, being
mindful of short-term transitions.
Comment: Multiple commenters supported a phased-in approach to the
inclusion of populations in mandatory reporting but provided different
recommendations about the approach CMS should take. One commenter
recommended that CMS collect feedback from affected and interested
parties on the most feasible reporting timeframe for specific
populations. Another commenter requested that States have the
flexibility to make the decisions about phasing in reporting of
populations that are challenging to report on a timeframe that is
feasible for each State. One commenter recommended that phasing in
reporting for any given population should be limited to no more than 3
years, while
[[Page 60298]]
others noted that 2 to 5 years is the minimum amount of time needed.
One commenter recommended that CMS extend the phase-in period beyond 5
years, proposing up to 7 years to phase in fully reporting all measures
for all populations. Several commenters recommended allowing more time
before CMS phases in mandatory reporting for other populations, such as
dually eligible beneficiaries; recommendations varied from as soon as 3
years to 10 years.
Response: Commenters had varying preferences regarding the amount
of time that we should provide for phasing in mandatory reporting on
specific populations; some commenters recommended that we give States
the flexibility to decide what populations they are able to report on,
based on their unique circumstances. While reporting on standardized
populations will help us achieve data consistency across States and
provide actionable data to identify disparities and support efforts to
improve the quality of health care, we recognize, based on the range of
years supported in public comments, that the ability of States to
report on the Child and Adult Core Sets for certain populations may
vary, and there are unique circumstances which may result in States'
inability to report on certain populations in a given year. As
discussed previously in this final rule, we have revised Sec.
437.10(b)(5) and (c) to specify that the Secretary will identify in
annual guidance the populations for which States may voluntarily, but
are not required to, report the Child and Adult Core Set measures for a
specific year. As further discussed previously in this final rule, this
same flexibility is not needed for the Health Home Core Sets due to the
ready availability of provider data, small population size, and ease of
measure calculation. In Sec. Sec. 437.10(b)(5)(i), 437.15(a)(4), and
(6) we also added an opportunity for States to request a 1-year
exemption from reporting mandatory populations for the Child and Adult
Core Sets for one or more Child or Adult Core Set measures if the State
demonstrates an inability to obtain access to data required to report
on the measure(s) for the population--for example, if a State is unable
to obtain a necessary data-sharing agreement between parties before the
reporting deadline. We will consider renewing exemptions for specific
populations on an annual basis. Additionally, we revised Sec.
437.15(a)(4) to specify that mandatory reporting would include both
fee-for-service and managed care delivery systems unless the population
is otherwise specified by the Secretary pursuant to Sec. 437.10(b)(5)
or the State has received an exemption. We will work collaboratively
with States to provide the technical assistance and reporting guidance
necessary to support improvements in reporting for certain populations.
We have also revised Sec. Sec. 437.10(b)(5), (c), and 437.15(a)(4)
of this final rule to specifically reference only the Child and Adult
Core Sets. This is because, as discussed previously, under this final
rule, Health Home Core Set reporting must include reporting on all
beneficiaries enrolled in an approved health home program.
Comment: Multiple commenters noted concerns with accessing claims
data for beneficiaries who may be enrolled in Medicaid only for premium
assistance programs. Multiple commenters requested that CMS provide
clarification that the rule would not apply to individuals who have
both Medicaid coverage and private insurance coverage, as the Medicaid
agency would not have access to claims information from the member's
private plan.
Response: We agree with the commenters that reporting Child and
Adult Core Set measures for beneficiaries whose Medicaid or CHIP
coverage is limited to payment of private insurance premiums and/or
cost sharing may be challenging, as States currently do not have
consistent access to data needed from the liable third-party payer, and
as discussed previously in this final rule, we are revising Sec.
437.10(b)(5) such that the Secretary will identify in annual guidance
populations for which States may, but are not required to, report the
Child and Adult Core Set measures. We will work with States to
determine reporting feasibility and the technical assistance needed for
mandatory Child and Adult Core Sets reporting on such beneficiaries,
and will update reporting guidance and mandatory reporting requirements
based on these assessments. Reporting for populations who are dually
eligible for Medicare and Medicaid is discussed below. We further note
that the process for delaying reporting under Sec. 437.10(b)(5) does
not apply to the Health Home Core Sets as discussed previously in this
final rule. As discussed previously, States are expected to have the
data they need to report on the Health Home Core Sets from health home
providers, and therefore, are not expected to experience the challenges
in reporting for beneficiaries whose Medicaid or CHIP coverage is
limited to payment of private insurance premiums and/or cost sharing
discussed above.
Comment: Several commenters opposed mandatory State reporting for
the dually eligible population and suggested that CMS should be the
responsible party for reporting on the dually eligible population as
Medicare is the primary payer for most benefits and services for these
beneficiaries. A few commenters recommended that CMS should limit
mandatory State reporting for dually eligible beneficiaries to delivery
systems or measures where the State is directly accountable. One
commenter recommended limiting reporting to States that operate
Statewide, fully-integrated models for dually eligible beneficiaries
(for example, fully integrated dual eligible special needs plans), and
one commenter recommended limiting reporting on Core Set measures for
dually eligible beneficiaries to measures for which the State is
directly accountable so that the quality reporting on dually eligible
beneficiaries is reflective of the payer of services.
Response: We recognize the concerns about States' ability to report
on the dually eligible population when States are not the primary payer
for most health care services for this population. We disagree that
States should not report on all dually eligible individuals in the
States' reporting of Core Sets measures. Dually eligible individuals
experience the health care system and incur health outcomes as
individuals, regardless of whether Medicare or Medicaid pays for the
service. The purpose of the Child and Adult Core Sets is to measure the
overall national quality of care for beneficiaries, which is not
limited to services reimbursed by Medicaid or CHIP. The main goal of
the health home programs is to improve health outcomes for
beneficiaries through care coordination that is intended to better link
primary, behavioral health, and long-term services and supports for
beneficiaries served by the health home program. The Health Home Core
Sets will be used for ongoing monitoring and evaluation purposes across
all State health home programs to measure this goal. As discussed
previously, States are expected to have the data they need to report on
the Health Home Core Sets from health home providers and therefore are
not expected to experience challenges in reporting for dually eligible
individuals. We recognize that States must obtain, link, and analyze
Medicare data in order to report the Child and Adult Core Sets of
measures for fee-for-service beneficiaries, and that States do not have
access to encounter
[[Page 60299]]
data for Medicare Part C (Medicare Advantage), and we expect to phase
in required reporting of Child and Adult Core Set measures for dually
eligible beneficiaries. We will include information, including
available technical assistance, on mandatory Child and Adult Core Sets
reporting for this population in annual reporting guidance. Since all
States that commented on the proposed rule, including those States that
currently participate in the Medicare-Medicaid Data Sharing Program,
requested more time to obtain, link, and analyze Medicare data, we will
work with States and interested parties to identify the timeframe for
which mandatory Child and Adult Core Sets reporting for dually eligible
beneficiaries will be required. Additionally, we will continue to
assess whether we can use T-MSIS or other alternative data sources to
calculate Child, Adult, and Health Home Core Sets measures on behalf of
States.
Comment: Several commenters expressed concern about access to and
the availability of assistance with using the Medicare FFS claims and
Part D events data that are needed to report on dually eligible
beneficiaries and were concerned that States would require extensive
resources to utilize the data. They further commented that CMS is
disadvantaging States, as this data is very difficult to obtain and out
of their control. A few commenters encouraged CMS to facilitate State
participation in the Medicare-Medicaid Data Sharing Program. A
commenter recommended CMS establish a standardized data license/sharing
agreement to facilitate Medicare data requests for the dually eligible
population.
Response: Since 2011, we have provided States access to Medicare
FFS claims and Part D events data for dually eligible beneficiaries,
including dually eligible beneficiaries whose Medicaid or CHIP coverage
is limited to payment of premiums and/or cost sharing (also known as
partial-benefit dually eligible beneficiaries), free-of-charge via the
Medicare-Medicaid Data Sharing Program. Information on the Medicare-
Medicaid Data Sharing Program, including how to request data and the
standard data sharing agreements, is available through the State Data
Resource Center. We acknowledge that not all States currently request
Medicare claims and events data, and that those States that do not
currently request Medicare claims and events data may need additional
time to request and effectively utilize these data. We also acknowledge
that the Medicare-Medicaid Data Sharing Program does not currently make
available Medicare Part C encounter data, as discussed in the response
below. Since all States that commented on the proposed rule, including
those States that currently participate in the Medicare-Medicaid Data
Sharing Program, requested more time to obtain, link, and analyze
Medicare FFS data, and in light of the systematic Medicare Part C data
access challenges, we anticipate that the Secretary's subregulatory
guidance issued under Sec. 437.10(b) may specify that mandatory Child
and Adult Core Sets reporting will not be required initially for dually
eligible beneficiaries. This approach will address concerns for States
that are not currently requesting Medicare claims and events data,
providing them additional time to gain familiarity with the available
claims and events data. Subregulatory reporting guidance will also
consider care delivery systems and data availability. Specific to
Health Home Core Sets, States collect data from the provider at the
program level for this population to inform the health home measures,
and therefore the health home measures do not rely on Medicare claims
data. Health home programs are an optional State benefit, and there is
the possibility that a dually eligible beneficiary could be enrolled in
both Medicare and a State health home program if the dually eligible
beneficiary has full Medicaid coverage (that is, a ``full-benefit
dually eligible beneficiary''). If a full-benefit dually eligible
beneficiary is enrolled in both a State health home program and
Medicare, the provider would submit data for health home measures to
the State, and the State would include this population in Health Home
Core Sets reporting. We will consider implications of data access when
reviewing measures for possible addition to the Health Home Core Sets
in future years.
Information on the Medicare-Medicaid Data Sharing Program,
including on how to request data and the standard data sharing
agreements, is available at https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/StateAccesstoMedicareData or by contacting the
State Data Resource Center at https://www.statedataresourcecenter.com/home/contact-us. We will take under advisement the commenters'
recommendations on additional technical assistance and resources for
using Medicare FFS data, and we will consider Medicare data
availability and ease of use when determining the Child and Adult Core
Sets reporting schedule for the dually eligible population in general.
Comment: Multiple commenters supported provision of technical
assistance to States on inclusion of those dually eligible for Medicare
and Medicaid and recommended that CMS provide open-source tools,
opportunities for shared learning, assistance in developing data
infrastructure, guidance on how to link Medicaid and Medicare data,
data infrastructure, model analysis with T-MSIS data, and standardized
Medicare data packages tailored to Core Set analysis. A commenter
recommended considering the work of the NQF Measure Application
Partnership (MAP) Dual Eligible Beneficiaries Workgroup when
considering measures for the Core Sets and data availability.
Response: We plan to provide technical assistance on Child, Adult,
and Health Home Core Sets reporting for dually eligible beneficiaries
and will take these ideas into consideration when developing technical
assistance resources and learning opportunities.
Comment: Several commenters were concerned about the lack of
available Medicare Part C encounter data. These commenters explained
that States cannot report on dually eligible beneficiaries enrolled in
Medicare Part C without these data.
Response: We recognize that we do not currently make available
Medicare Advantage data to States free-of-charge via the Medicare-
Medicaid Data Sharing Program. We are looking into how to address this
issue. We do not intend to require that States report Child and Adult
Core Set measures on dually eligible beneficiaries enrolled in Medicare
Part C (that is, in Medicare Advantage) until such data are available.
Specific to Health Home Core Sets, States collect data from the
provider at the program level for this population to inform the health
home measures, and therefore the health home measures do not rely on
Medicare claims data. We will consider implications of data access when
reviewing measures for possible addition to the Health Home Core Sets
in future years.
Comment: One commenter expressed concern with reporting of Medicaid
FFS beneficiaries in their State, as they may not meet continuous
enrollment requirements for quality measurement. Another commenter
noted that there is a significant burden for including Medicaid FFS
beneficiaries in State-wide reporting of hybrid measures.
Response: The purpose of the Child and Adult Core Sets, as
suggested by sections 1139A and 1139B of the Act, is
[[Page 60300]]
to measure the overall national quality of care for beneficiaries,
monitor performance at the State level, and improve the quality of
health care. The main goal of the health home programs is to improve
health outcomes for beneficiaries through care coordination that is
intended to better link primary, behavioral health, and long-term
services and supports for beneficiaries served by the health home
program.47 48 The Health Home Core Sets will be used for
ongoing monitoring and evaluation purposes across all State health home
programs to measure progress towards this goal. While we recognize the
additional burden to States that may not currently include Medicaid FFS
beneficiaries in their reporting, in order to improve the quality of
care delivered to all beneficiaries, States must include in reporting
the entire population covered by Medicaid and CHIP (or served by the
applicable health home program), including Medicaid FFS beneficiaries,
except to the extent the Secretary exempts a population from reporting
for Child and/or Adult Core Sets measures in annual guidance or grants
a state exemption for a specific population for a specific reporting
year, as discussed in detail previously in this section. We have
revised Sec. 437.15(a) accordingly. The vast majority of measures on
the Core Sets (84 percent of the 2023 and 2024 Child Core Set and
behavioral health measures on the Adult Core Set can be calculated
using administrative claims or survey data. One hundred percent of the
2023 and 2024 section 1945 Health Home Core Set as well as 100 percent
of the measures under consideration for the section 1945A Health Home
Core Set) can be calculated using administrative claims data. We are
assessing the resources and technical assistance to support States in
using other data sources more widely. In order to be included in Core
Set reporting, beneficiaries must still meet enrollment requirements
for quality measurement, which are established by the measure stewards
for each measure and based on a beneficiary's continuous enrollment in
Medicaid and CHIP. Additionally, for Health Home Core Sets a
beneficiary must also be enrolled in an approved health home program.
FFS or other beneficiaries who do not meet the enrollment requirements
for a given measure would not be included in a State's report.
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\47\ https://www.medicaid.gov/resources-for-states/medicaid-state-technical-assistance/health-home-information-resource-center/index.html.
\48\ https://www.medicaid.gov/resources-for-states/medicaid-state-technical-assistance/health-home-information-resource-center/1945a-health-home-resources/index.html.
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Comment: One commenter suggested CMS test the validity of mandatory
measures that have been expanded to include additional populations,
specifically populations that may be more difficult to include, prior
to public reporting, and that CMS ensure that risk adjustment models of
mandatory measures are robust enough to provide fair comparisons when
including expanded populations. This commenter further recommended that
CMS work with measure developers to evaluate the fit of the risk
adjustment models for mandatory measures prior to reporting results
publicly to ensure they generate meaningful information and allow for
fair comparisons.
Response: We anticipate that our Core Set reporting guidance will
align with measure steward technical specifications with regard to
defining the populations included in the measure and to risk
adjustment. If the measure steward includes risk adjustment for a
measure on the Core Sets, we will include risk adjustment for that
measure. We work with measure stewards to adapt measures for State
level reporting and provide appropriate reporting guidance. The issue
of validity testing of mandatory measures is outside the scope of this
rulemaking.
Comment: Several commenters noted that decisions about whether to
submit health care data necessary to calculate Core Set measures for
beneficiaries receiving care from Indian Health Care Providers (IHCPs)
rest with the Tribes and Tribal Organizations, and any CMS rules about
data completeness must respect Tribal sovereignty and Tribes' decisions
about whether to submit health care data. One commenter noted that the
addition of health care facility data from IHS, Tribes, and Tribal
Organizations would require significant technical assistance and
funding from CMS to facilitate the development of needed infrastructure
to support these providers' readiness to capture required data
elements, and to assist with data transmission.
Response: We understand that Tribes and Tribal providers take
seriously their role in protecting the confidentiality of American
Indian/Alaska Native (AI/AN) data and note that State Core Set data is
de-identified before it is submitted to us for Core Set reporting. We
also recognize that States enter into individual contractual and data
use agreements with Tribes and Tribal providers that may affect the
availability of Tribal data for Core Sets reporting. States might
choose to require their Medicaid providers to report certain data to
the State as a condition of receiving Medicaid payment, if doing so
would help the State comply with the Core Sets reporting requirements.
We strongly encourage States to consult with Tribes and to coordinate
with IHS, and Tribes and Tribal Organizations, to discuss reporting of
Child and Adult Core Set measures regarding the services provided by
IHS and Tribal health care providers in their State. Collaborative
relationships between government entities and Tribes are essential to
responsible and effective data use and to understanding and addressing
the gaps in these data,\49\ which limit analyses that support public
health decision-making in AI/AN communities.\50\ Any delay of reporting
data for AI/AN beneficiaries will impede efforts to improve health
outcomes for these populations, and we encourage Tribes to report Core
Set data to their respective States to help improve the quality of
their State's Medicaid program, and ultimately the quality of health
care provided to AI/AN individuals.
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\49\ https://aspe.hhs.gov/reports/gaps-strategies-improving-american-indianalaska-nativenative-american-data#TOC.
\50\ https://www.gao.gov/products/gao-22-104698.
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As discussed previously in this final rule, States are required to
report Child and Adult Core Sets quality measure data for all
populations, unless a population is identified as optional in annual
subregulatory guidance to be issued by CMS, and States may request a 1-
year exemption from reporting mandatory populations for one or more
measures on the Child and Adult Core Sets if the State demonstrates an
inability to obtain access to data, which may include for example, an
inability to obtain needed third-party data or to finalize a necessary
data-sharing agreement between parties before the reporting deadline.
Moreover, this final rule requires States and health home providers to
report data on all populations enrolled in the applicable health home.
If Tribes or Tribal Organizations are providing section 1945 or section
1945A health home services, sections 1945 and 1945A of the Act require
them to report data to the State as a condition of payment for these
health home services, as discussed in more detail previously in this
final rule.
E. Application of the Child and Adult Core Sets to CHIP
As discussed in section II.E. of the proposed rule, in Sec. Sec.
437.15(b), 457.700 and 457.770 we proposed the following requirements
for CHIP programs: to require that separate CHIPs report on all
measures in the Child Core Set in
[[Page 60301]]
accordance with the requirements outlined in the proposed rule and
include all CHIP beneficiaries in State reporting, including pregnant
individuals receiving child health assistance coverage for the duration
of pregnancy in States that elect to provide coverage through the group
known as the `unborn option'. Separate CHIP programs are encouraged,
but not required, to report on the measures in the Adult Core Set.
We received public comments on the application of mandatory
reporting to CHIP, and in general, commenters supported the proposed
process. We are finalizing these provisions with revisions to
Sec. Sec. 437.15(b)(1) and 457.770(c) as discussed in section II.E.1.
of this final rule. Below is a summary of the public comments we
received regarding this section and our responses.
Comment: Several commenters supported CMS' proposal, in section
II.E. of the proposed rule, to include pregnant individuals receiving
coverage under CHIP, including those provided CHIP child health
assistance for the duration of pregnancy (also referred to as the
``unborn option''), in the mandatory reporting requirements for the
Child Core Set, if the pregnant individual meets the age parameters for
the measures. One commenter requested guidance on whether States would
be required to report quality measures for pregnant individuals
receiving coverage through the option to extend special CHIP child
health assistance for the duration of pregnancy and whether States
would be required to include this population in Adult Core Set
reporting.
Response: We appreciate the support from these commenters. We are
finalizing the mandatory reporting requirements as proposed in Sec.
457.770(a) to require States to include this population of CHIP
beneficiaries when reporting on quality measures in the Child Core Set.
States that provide coverage for the duration of pregnancy under CHIP
would be required to include this population in reporting of the Child
Core Set if the participants meet the age parameters for the measures
referenced in Sec. 457.770(a) of this final rule. Reporting on the
Adult Core Set is encouraged, but voluntary, for beneficiaries enrolled
in CHIP in Sec. 457.770(b) of this final rule.
Comment: One commenter recommended that individuals receiving
coverage under CHIP should also be included in reporting for any
measures from the Adult Core Set that the State reports on for their
CHIP population.
Response: Section 1139B(b)(3)(B) of the Act makes reporting by
States on the Adult Core Set measures mandatory only with respect to
the quality of behavioral health care provided to Medicaid-eligible
adults. As a result, States are encouraged, but not required, to report
on the measures in the Adult Core Set for beneficiaries in separate
CHIP programs as per Sec. 457.770(b) of this final rule.
Comment: One commenter requested guidance on whether CMS would give
States the option to report by combining the Child Core Set State-level
data and section 1945 health home program data.
Response: We will provide technical assistance and further details
on how small population sizes should be handled through our reporting
guidance. Under this final rule, data would be reported separately at
the health home program level for the Health Home Core Sets and the
State level for the Child and Adult Core Sets. Given these different
denominators for these obligations, we do not plan to combine these
reporting requirements.
Comment: One commenter noted that their State enrollment under the
special CHIP child assistance option for pregnant individuals is very
low and reporting on it will have little impact on the overall rate.
Another commenter noted that many individuals who receive special CHIP
child assistance for pregnant individuals would not meet the
eligibility requirements for reporting, such as receiving CHIP for the
duration of the pregnancy or age requirements, and as such, collection
of the data may not be a good use of data resources.
Response: While the special CHIP child assistance for pregnant
individuals is reflective of a very specific and relatively small
population, we believe it is important to gather data for as many
populations as possible. In some cases of small population sizes, core
set measure data would not be reported separately, but would be
included in reports of larger populations. We will provide technical
assistance and further details on how small population sizes should be
handled through our reporting guidance. We will follow data suppression
policies for measure stewards in addition to our Cell Size Suppression
Policy such that if sample sizes are too small, data will not be
publicly reported to avoid a potential violation of privacy.\51\
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\51\ CMS Cell Suppression Policy: https://www.hhs.gov/guidance/document/cms-cell-suppression-policy.
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Comment: One commenter encouraged CMS to adhere to measure steward
specifications and urged that if CMS expands the denominator beyond
those specifications, such as including individuals without 12 months
of data, CMS should assess the validity and actionability of the
measures.
Response: We will take this feedback into consideration when
developing Core Set reporting guidance. We will provide technical
assistance and further details on enrollment requirements for inclusion
of beneficiaries in Core Set reporting through our reporting guidance.
In order to be included in Core Set reporting, beneficiaries must still
meet enrollment requirements for quality measurement, which are
established by the measure stewards for each measure and based on a
beneficiary's continuous enrollment in Medicaid and CHIP. This would
ensure that the State has enough time to render services during the
measurement period and would be based on a beneficiary's enrollment
date in Medicaid and CHIP (not inclusive of retroactive eligibility).
In making measure adaptations, we work closely with measure stewards to
develop reporting guidance and to make as few adaptations to the
technical specifications as possible.
1. Separate Reporting of the Child Core Set for Medicaid and CHIP
Beneficiaries
As discussed in section II.D.4. of the proposed rule, in Sec. Sec.
437.15(b) and 457.770(c), we proposed that States with a separate CHIP
report on Child Core Set measures in three categories: Medicaid and
CHIP combined; Medicaid inclusive of CHIP-funded Medicaid expansion
(Titles XIX and XXI); and separate CHIP (Title XXI). We also proposed
that reporting guidance would include attribution rules, to specify in
which program (Medicaid or CHIP) a State would count a child who
transitioned between programs within a reporting period.
In response to comments received, we have revised Sec. Sec.
437.15(b)(1)(i) and (ii), and 457.770(c), to specify that States with
separate CHIP programs report on the Child Core Set measures in two
categories instead of three as originally proposed: (1) separate CHIP
(Title XXI) and (2) Medicaid inclusive of CHIP-funded Medicaid
expansion (Titles XIX and XXI). Below is a summary of the public
comments we received regarding this section and our responses.
Comment: Several commenters supported the proposed rule proposal to
require adherence to the same reporting guidance for Medicaid (funded
through Title XIX and Title XXI) and separate CHIP programs, and
recommended that the proposed language at Sec. 437.15(b) be revised to
clearly articulate that States with a separate CHIP program report on
[[Page 60302]]
Child Core Set measures in three categories: Medicaid and CHIP
combined; Medicaid inclusive of CHIP-funded Medicaid expansion (Titles
XIX and XXI); and separate CHIP (Title XXI). Several other commenters
recommended that CMS simplify the reporting categories to instead only
require reporting on two categories for Medicaid inclusive of CHIP-
funded Medicaid expansion (Titles XIX and XXI) and separate CHIP (Title
XXI).
Response: In response to public comment, we have revised Sec. Sec.
437.15(b)(1)(i) and (ii), and 457.770(c), to specify that States with
separate CHIP programs will be required to report on the Child Core Set
measures in two categories, instead of three as originally proposed.
The category of Medicaid inclusive of CHIP-funded Medicaid expansion
includes all Medicaid enrollees, regardless of whether they are funded
by Title XIX or XXI. We will aggregate the separate CHIP and Medicaid
inclusive of CHIP-funded Medicaid expansion data to create the Medicaid
and CHIP combined category, alleviating the burden on States to create
and report that data. We believe the change from the three originally
proposed reporting categories to the two reporting categories described
previously in this final rule maintains the intent of the proposed
rule.
Comment: Several commenters did not support separate reporting of
children in Medicaid and CHIP. They thought that it added little value
and would result in an additional reporting burden, as combined
reporting more closely aligns with how services are provided. Instead,
one commenter recommended combining reporting for Medicaid and CHIP,
and using attribution to determine to which program beneficiaries
should be assigned. One commenter recommended CMS allow aggregate
reporting to align with current State practices, while another
commenter asked if separate or combined reporting of CHIP could be
determined at the State level.
Response: Separate CHIP programs have different service
requirements than Medicaid. Therefore, we expect that results for
certain measures could vary within States for separate CHIP and
Medicaid. We believe these differences are important to document, and
therefore are maintaining the requirement at Sec. Sec. 437.15(b) and
457.770(c) that States with a separate CHIP report separate CHIP data
separately from Medicaid data. Meanwhile, we have updated the reporting
categories to incorporate both Title XIX and Title XXI-funded Medicaid
under one category to reduce State burden and to reflect the fact that
the source of funds (Title XIX or Title XXI) providing the Federal
match for a child enrolled in Medicaid does not impact which or how
services are provided. We will also aggregate the separate CHIP and
Medicaid data to obtain the combined Medicaid and CHIP results, rather
than requiring States to report the combined results, to reduce State
burden.
Comment: One commenter suggested that any separate CHIP reporting
should be limited to administrative measures that are in the control of
MCOs.
Response: The Core Sets are State-level and health home program-
level reporting programs, not managed care or health plan-level
reporting programs. One of the goals of mandatory reporting is to
provide inclusive data on quality and performance for all
beneficiaries, regardless of delivery system. We will provide technical
assistance to address the needs of States and State partners to report
the Core Sets.
Comment: Several commenters noted that if States were required to
report results for Medicaid and CHIP separately, a separate CAHPS
survey for CHIP would be required. Multiple surveys would result in
significant cost increases, require additional time to implement, and
increase the potential for insufficient sample sizes.
Response: We will take this feedback into consideration as part of
the guidance process that is discussed in the rule. Section 2108(e)(4)
of the Act requires states to collect and report CAHPS survey results
for Title XXI CHIP programs (see CHIPRA section 402(a)(2)) as part of
their annual reports to the Secretary. Reporting CAHPS survey results
separately currently is encouraged for voluntary Core Set reporting,
and several States successfully do so. We note that previous CMS
guidance outlines how States can sample and report CHIP and Medicaid
results separately for CAHPS.\52\
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\52\ Fact Sheet 2012: https://www.medicaid.gov/medicaid/quality-of-care/downloads/cahpsfactsheet.pdf.
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Comment: One commenter supported the proposal that CMS include
attribution rules in reporting guidance for counting children who move
between Medicaid and separate CHIP. One commenter recommended that
States be required to include children that meet continuous enrollment
criteria in reporting for CHIP, as is required for Medicaid reporting
and enrollment criteria, in order to allow for better comparisons. This
commenter requested a separate population category for enrollees
transitioning from Medicaid to CHIP if CMS were to require reporting on
this group, noting that combining these data for children who
transition between programs would be burdensome. Multiple commenters
acknowledged the need to include children in Child Core Set reporting
who transition between Medicaid and CHIP in order to promote
consistency and prevent duplicative reporting. Some commenters raised
concerns that inconsistencies in Medicaid and CHIP requirements could
make it difficult to combine these two groups for reporting.
Response: We plan to provide detailed guidance about attribution
rules in the annual reporting guidance required under Sec. 437.10(b),
as finalized in Sec. 437.10(b)(6) of this rulemaking with minor
changes. We note the importance of capturing data for the population of
children who transition between Medicaid and CHIP, given the
implications of insurance churn on health care quality.
Comment: One commenter noted that some States with small separate
CHIP programs may have difficulty reporting on their CHIP population
and requested technical assistance and support from CMS to address data
collection and calculation challenges.
Response: We appreciate these comments and concerns and will
provide technical assistance to meet the needs of States and State
partners.\53\
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\53\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
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F. Ensuring Compliance With the Mandatory Reporting Requirements
As discussed in section II.F. of the proposed rule, in Sec.
437.20, we proposed to require that States submit a Medicaid SPA
attesting that the State agency would report on the Child, Adult, and
Health Home Core Sets in accordance with the requirements in the final
rule. Health Home SPAs would also include an attestation that the State
will require its providers of health home services to report to the
State on the measures that the State has to report. With these
attestations in the State plan, we would have authority under section
1904 of the Act to withhold Federal Medicaid payments, in whole or in
part, if an agency fails to comply with the Medicaid reporting
requirements.
We also proposed changes to Sec. 433.112 which would apply
existing Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy, Security, Breach Notification, and Enforcement Rules
under 45 CFR parts 160 and 164, the HIPAA electronic
[[Page 60303]]
transactions standards under 45 CFR part 162, and the health
information technology standards under 45 CFR part 170 subpart B to the
Core Sets.
We received public comments on compliance requirements, and in
general, commenters supported the proposed process. We are finalizing
these provisions with a minor wording change to Sec. 437.20(a) to
clarify that reporting on Health Home Core Sets measures applies to all
populations served by the health home and other minor wording changes
to clarify cross-references within the same subpart. Below is a summary
of the public comments we received regarding this section and our
responses.
Comment: Several commenters supported the proposed standards that
States must meet to qualify for enhanced Federal matching funds for
Medicaid systems and encouraged the Secretary to use this authority to
enforce compliance with mandatory reporting of the Core Set measures.
One commenter asked for more information on Federal matching funds for
systems.
Response: We thank the commenters for their support for our
proposal to use these Federal authorities to enforce compliance with
Core Set requirements. CMS regulations at 42 CFR part 433, subpart C
specify conditions that State Medicaid systems must meet in order for
the State's expenditures on mechanized claims processing and
information retrieval systems to be matched at the 90 and 75 percent
rates described in section 1903(a)(3)(A)(i) and (B) of the Act. These
conditions include industry standards described in Sec.
433.112(b)(12), which with the publication of this final rule now
include standards and protocols for reporting on the Child and Adult
Core Sets and the Health Home Core Sets, as relevant to the specific
State Medicaid system or module. Under these regulations, which
implement section 1903(a)(3)(A)(i) and (B) of the Act, enhanced FFP is
available at 90 percent for State expenditures for the design,
development, and installation (including of enhancements) of qualifying
State Medicaid systems, and at 75 percent for State expenditures for
operations of such systems, once approved by CMS, in accordance with
applicable Federal requirements.\54\ Furthermore, in accordance with
regulations at Sec. Sec. 433.117 and 433.119, we may not approve
replacement State systems or may not reapprove existing State systems
if the State does not meet Core Set reporting requirements that are now
described in Sec. 433.112(b)(12) and cross-referenced in Sec.
433.116(c), which means that we would not approve or reapprove a
Federal matching percentage of 75 percent under section 1903(a)(3)(B)
of the Act for such systems.\55\
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\54\ See section 1903(a)(3)(A)(i) and (B) of the Act, 42 CFR
433.15(b)(3) and (4), subpart C of 42 CFR part 433, and State
Medicaid Director Letter (SMDL) #22-001.
\55\ Medicaid Enterprise Systems Compliance and Reapproval
Process for State Systems with Operational Costs Claimed at the 75
Percent Federal Match Rate CIB at https://www.medicaid.gov/federal-policy-guidance/downloads/cib052423.pdf.
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Additional information about FFP rates for State Medicaid system
design, development, and installation (including of enhancements) and
operation available under section 1903(a)(3)(A)(i) and (B) of the Act
can be found in the Mechanized Claims Processing and Information
Retrieval Systems regulations at 42 CFR part 433, subpart C.
Separately, under section 1903(a)(3)(A)(iii) of the Act, State
expenditures for Medicaid system development and modifications
necessary for collecting and reporting on child health quality measures
are matched at the State's FMAP rate as defined in section 1905(b) of
the Act.
Comment: Some commenters suggested CMS should develop more explicit
guidance outlining specific, graduated enforcement mechanisms for
States that remain out of compliance with quality reporting
requirements, in order to ensure clear enforcement action is taken
against States and other entities that fail to comply and encourage
State corrective action.
Response: As noted previously in this final rule, States will be
required to submit a Medicaid SPA attesting that the State agency will
report on the Child, Adult, and Health Home Core Sets in accordance
with the requirements in 42 CFR part 437, as finalized in Sec. 437.20.
Since States have to attest that they will meet the mandatory reporting
requirements, we will be able to withhold Federal Medicaid payments, in
whole or in part, from a State that is non-compliant with these
reporting requirements in accordance with section 1904 of the Act and
implementing regulations at 42 CFR 430.35. We will be able to withhold
Federal funds under Title XXI for noncompliance with the reporting
requirements for CHIP in accordance with Sec. 457.204 once Sec.
457.770 is codified. The requirement at Sec. 437.20 to submit a SPA
does not apply to the CHIP agency. The CHIP State plan already includes
an attestation in section 9.4 that ``the State assures it will collect
all data, maintain records and furnish reports to the Secretary at the
times and in the standardized format that the Secretary requires.'' All
States have made this attestation in the current version of their State
plan. Graduated enforcement mechanisms for compliance with Core Sets
reporting requirements due to issues with State data systems will align
with existing CMS policy regarding State corrective action plans.\56\
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\56\ Medicaid Enterprise Systems Compliance and Reapproval
Process for State Systems with Operational Costs Claimed at the 75
Percent Federal Match Rate CIB at https://www.medicaid.gov/federal-policy-guidance/downloads/cib052423.pdf.
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Comment: Several commenters supported the proposed requirement that
States amend their State Plans to indicate that they would report on
the Core Sets in order to give CMS clear authority to enforce the Core
Set reporting requirements by withholding Federal Medicaid payments
under section 1904 of the Act in the event of noncompliance by a State.
One commenter requested clarification on the deadline for submission of
the SPA.
Response: We appreciate the support for this proposed Medicaid
requirement at Sec. 437.20, which we are finalizing as proposed in
this rulemaking. We plan to discuss details of changes to the SPA,
including the deadline for submission, in annual reporting guidance.
Comment: Several commenters suggested that requiring Health Home
programs to submit Core Set measures to the State as a condition of
receiving payment, in addition to the State reporting to CMS, is
duplicative and redundant.
Response: While we appreciate the submission of these comments, the
proposed rule implements statutory reporting requirements that health
home providers must meet, as a condition of payment, under sections
1945(g) and 1945A(g)(1) of the Act. If a Health Home provider is
submitting all required data into a State-based system that the State
is then using to calculate and report the Health Home Core Sets
measures to CMS, that would satisfy the statutory requirement for
providers under sections 1945(g) and 1945A(g)(1) of the Act.
Comment: A few commenters recommended that CMS change 42 CFR
431.16, which implements section 1902(a)(6) of the Act, to specify that
the State plan requirements include the reporting of the Core Sets and
underscore the importance of State compliance with Core Sets reporting.
Response: Section 431.16 requires that States comply with all
reporting requirements established by the Secretary and that their
State plans reflect that the State will do so. Section
[[Page 60304]]
431.16 does not list any specific reports that States are required to
submit, and we do not believe it would be appropriate to single out
Core Sets reporting alone. Further, it is not necessary to do so, as
the current language of Sec. 431.16 is broad enough to encompass these
newly finalized Core Sets reporting requirements (as they pertain to
Medicaid), and because Sec. 437.20 of this final rule sets forth the
requirement for States to submit a State plan amendment attesting to
compliance with the Core Sets reporting requirements.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
seq.), 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. For the purpose of the PRA and this section of
the preamble, collection of information is defined under 5 CFR
1320.3(c) of the PRA's implementing regulations.
To fairly evaluate whether an information collection must be
approved by OMB, section 3506(c)(2)(A) of the PRA 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 our August 22, 2022 (87 FR 51303) proposed rule, we solicited
public comment on each of these issues for the following provisions
that contain information collection requirements. As stated in section
II. of this final rule, we received 93 public comments on the proposed
rule, but only one of those comments was related to the rule's
collection of information requirements. The comment and our response
can be found in section III.C. of this preamble.
A. Wage Estimates
Private Sector, States, and Territories: To derive average costs,
we used data from the U.S. Bureau of Labor Statistics' May 2022 \57\
National Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/oes_nat.htm). Table 1 presents BLS' mean hourly
wage along with our estimated cost of fringe benefits and other
indirect costs (calculated at 100 percent of salary) and our adjusted
hourly wage.
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\57\ The costs associated with our August 22, 2022, proposed
rule differ from the costs in this final rule since the proposed
rule used BLS' May 2020 mean hourly wages whereas this final rule
uses BLS' 2022 wage estimates.
Table 1--National Occupational Employment And Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
Occupation title code wage ($/hr) other indirect hourly wage ($/
costs ($/hr) hr)
----------------------------------------------------------------------------------------------------------------
Business Operations Specialists................. 13-1000 40.04 40.04 80.08
Chief Executives................................ 11-1011 118.48 118.48 236.96
Computer Programmers............................ 15-1251 49.42 49.42 98.84
Data Entry/Information Processing Workers....... 43-9020 18.97 18.97 37.94
General Operations Manager...................... 11-1021 59.07 59.07 118.14
Statistician.................................... 15-2041 50.73 50.73 101.46
----------------------------------------------------------------------------------------------------------------
As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, we believe that doubling
the hourly wage to estimate total cost is a reasonably accurate
estimation method.
To estimate the burden on States, it was important to consider the
Federal government's contribution to the cost of administering the
Medicaid and CHIP programs. The Federal government provides Federal
Medicaid funds for medical assistance based on an FMAP that is
established for each State, based on the per capita income in the State
as compared to the national average. FMAPs range from a minimum of 50
percent in States with higher per capita incomes to a maximum of 83
percent in States with lower per capita incomes. States receive an
``enhanced'' FMAP for administering their CHIP programs, ranging from
65 to 85 percent. Medicaid funding for U.S. territories works a bit
differently than funding for the 50 States and District of Columbia.
Section 5101 of subtitle A of title V of division FF of the CAA, 2023
permanently set the FMAP for the four smaller territories (the Virgin
Islands, Guam, the Northern Mariana Islands, and American Samoa) under
Medicaid at 83 percent. Puerto Rico's FMAP under Medicaid is
statutorily set at 55 percent but has been temporarily increased to 76
percent until September 30, 2027.\58\ For each territory, the annual
amount of available Federal matching funds is capped. For Medicaid, all
States (including the territories) receive a 50 percent Federal
matching rate for activities found necessary by the Secretary for the
proper and efficient administration of the Medicaid program. As noted
previously in this final rule, States may receive higher Federal
matching rates for expenditures on certain services and for certain
systems improvements, redesign, or operations, up to 90 percent. As
such, in considering the Federal contribution to the costs of
administering the Medicaid and CHIP programs for purposes of estimating
State burden with respect to collection of information, we elected to
use the higher end estimate that the States would contribute 50 percent
of the costs, even though the burden would likely be much smaller.
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\58\ See section 1905(ff) of the Act.
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Beneficiaries: We believe that the cost for beneficiaries
undertaking administrative and other tasks on their own time is a post-
tax wage of $21.98/hr. The Valuing Time in U.S. Department of Health
and Human Services Regulatory Impact Analyses: Conceptual Framework and
Best Practices \59\ identifies the approach for valuing time when
individuals undertake activities on their own time. To derive the costs
for beneficiaries, a measurement of the usual weekly
[[Page 60305]]
earnings of wage and salary workers of $1,059 \60\ for 2022, divided by
40 hours to calculate an hourly pre-tax wage rate of $26.48/hr. This
rate is adjusted downwards by an estimate of the effective tax rate for
median income households of about 17 percent or $4.50/hr ($26.48/hr x
0.17), resulting in the post-tax hourly wage rate of $21.98/hr.
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\59\ https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//176806/VOT.pdf.
\60\ https://fred.stlouisfed.org/series/LEU0252881500A.
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Unlike our State and private sector wage adjustments, we are not
adjusting beneficiary wages for fringe benefits and other indirect
costs since the individuals' activities, if any, would occur outside
the scope of their employment.
B. Information Collection Requirements (ICRs)
The following collection of information requirements and burden
estimates were posted for public review and submitted to OMB for review
under control number 0938-1188 (CMS-10434 #26 for the Child Core Set
and the Adult Core Set and CMS-10434 #47 for the Health Home Core Sets)
in association with the August 22, 2022 proposed rule.
Under sections 1139A, 1139B, and 1902(a)(6) of the Act, we have the
authority to collect quality metrics on State-specific Medicaid and
CHIP programs for the purpose of: measuring the overall national
quality of care for Medicaid and CHIP beneficiaries, monitoring
performance at the State-level, and improving the quality of health
care. Under sections 1902(a)(6), 1945(c)(4)(B), 1945(g), and 1945A(g)
of the Act, in this final rule, we are requiring States that are
implementing the section 1945 and/or section 1945A health home benefits
to report on certain quality measures to the Secretary and to require
their health home providers to report on these same measures to the
State. The reported data is intended to provide a comprehensive
landscape of the quality of care provided by Medicaid and CHIP, because
the measures focus on a range of topics including access to primary and
preventive care, maternal and perinatal health care, care of acute and
chronic conditions, behavioral health care, dental and oral health
care, long term services and supports, and overall experience of care.
Currently, Child, Adult, and section 1945 Health Home Core Sets
reporting is voluntary for States but highly encouraged. Under this
final rule, our voluntary annual reporting requirements will become
mandatory for States for the: Child Core Set (CMS-10434 #26),
behavioral health measures in the Adult Core Set (also CMS-10434 #26),
and the section 1945 and forthcoming section 1945A Health Home Core
Sets (CMS-10434 #47).\61\ This final rule does not add, remove, or
revise any of the existing measures in any of the aforementioned Core
Sets. Annual updates to the Core Sets will continue to be made as
required by sections 1139A and 1139B of the Act for the Child and Adult
Core Sets and this annual update process will also be applied to both
Health Home Core Sets as described in section I.C. of this preamble and
Sec. Sec. 437.10(a)(2) and (e). Mandatory reporting of the Child Core
Set and behavioral health measures on the Adult Core Set will impact
all 50 States, DC, Puerto Rico, Guam, and the Virgin Islands as
described in section II.A. of this final rule and in Sec. 437.1. The
Health Home Core Sets requirements will apply if a State (as defined
under section 1101 of the Act for purposes of Title XIX) has an
approved Health Home SPA under section 1945 or 1945A of the Act (see
Sec. 437.1(d)(2)), and the burden associated with the mandatory
reporting requirement is not expected to influence the number of health
home SPAs. Currently, 19 States and DC have a total of 34 section 1945
Health Home SPAs.
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\61\ Core Set Measure lists: https://www.medicaid.gov/medicaid/quality-of-care/index.html.
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Under this final rule, we anticipate that the mandatory reporting
burden for States would increase in comparison to the current voluntary
Core Set reporting burden, including anticipated burden to States for
system changes as a result of this final rule. This is due to the
mandatory nature of the data collection which may increase: the number
of measures reported by States, adherence to the reporting guidance
provided by CMS, and stratification of data by delivery system and
demographic characteristics. However, many of the mandatory measures
can be calculated from alternate data sources. For example, we have
been working to use T-MSIS (CMS-R-284, OMB 0938-0345) reporting to
generate measure reporting on behalf of States. Among the three Core
Sets, approximately 50 measures will become mandatory (the Child Core
Set measures, behavioral health measures on the Adult Core Set, and the
1945 and 1945A Health Home Core Sets of measures for States with a
health home program), two of which we currently report for States and
Puerto Rico using alternate data sources. The remaining non-behavioral
health Adult Core Set measures will remain voluntary for States to
report. The burden to report voluntary measures is not included in this
final rule but is submitted annually to OMB for their approval under
control number 0938-1188 (CMS-10434 #26). We are currently assessing
whether T-MSIS could be used to report any of the remaining measures.
If so, this will reduce the number of measures that States will be
required to calculate.
The data fields included in Core Set reporting templates are
determined by the measure stewards who own the measures. We are not the
measure steward for most measures, and therefore, do not control the
actual data fields for most of the measures in the Core Sets. As a
result, the templates used for Core Sets reporting will not be
published for public comment. Instead, measure stewards implement a
separate process for public comment during measure development and
measurement updates. We also have recommendations in the CMS Measures
Management System Blueprint for a similar process for public comment
during measure development.\62\
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\62\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.
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We are adding SPA preprints to the final rule package under control
number 0938-1188 (CMS-10434 #26) for the Child Core Set and the Adult
Core Set and CMS-10434 #22, entitled: ``Health Home State Plan
Amendment (SPA)'') for the Health Home Core Sets. These preprints were
excluded from the proposed rule package, but the contents of the
preprints were described under the collection of information
requirements, and the burden estimates were included under ICR #1 in
the proposed rule. The final rule's preprint does not deviate from
those descriptions: ``that the agency would report on the Child and
Adult Core Sets in accordance with the requirements in Sec.
437.20(a)'' and that States would need ``to submit a SPA attesting that
the agency would report on the Health Home Core Sets in accordance with
the requirements in Sec. 437.20(a).'' Additionally, we are changing
the package under which the Health Home Core Sets SPA preprint is
associated from control number 0938-1188 (CMS-10434 #47) to 0938-1188
(CMS-10434 #22, entitled: ``Health Home State Plan Amendment (SPA)''),
as this package (CMS-10434 #22) is associated with the health home
program State plan requirements. The requirements for the SPA are the
same, and the burden set out in the proposed rule is the same as in the
final rule (at 54 responses x 1
[[Page 60306]]
hour/response = 54 hours total time); only the location is being
changed.
Subsequent to the proposed rule we have revised Sec. Sec.
437.10(b)(5)(i) and 437.15(a)(4) and (6) in this final rule to allow
States to request a 1-year exemption from Child and Adult Core Sets
reporting for specific populations that have not already been exempted
by the Secretary for the year in question in the annual subregulatory
guidance. Our assessment of the burden of the exemption request process
has been added under ICR #5 (54 responses x 4 hour/response = 216 hours
total time). This option is available to all States, and the burden
includes all States and Territories subject to mandatory reporting
requirements for the Child and Adult Core Sets who may submit an
exemption request. As required by the PRA, we will solicit public
comment via 60-day and 30-day notices that we will issue in the Federal
Register separate from this rulemaking document as this voluntary
requirement takes effect September 1, 2024.
As noted previously in this rule, we received one public comment
related to the collection of information requirements calculation of
the burden estimate, which applied to the estimates provided for
reporting the Child, Adult, and Health Home Core Sets. The comment, and
our response can be found in section III.C. of this final rule.
The burden for reporting voluntary Adult Core Set measures (the
measures outside of behavioral health measures) for States to report is
not included in this rule's ICR discussions as the mandatory reporting
requirements being implemented with this final rule do not apply to the
voluntary measures; however, these costs will be included under control
number 0938-1188 (CMS-10434 #26). The burden to health home providers
for reporting section 1945 and section 1945A Health Home Core Sets data
to States is not included in this rule's ICR discussions or under
control number 0938-1188 (CMS-10434 #47) as this final rule outlines
State requirements to comply with reporting the Health Home Core Sets.
The burden to health home providers for reporting the section 1945 and
section 1945A Health Home Core Sets along with the development of a
Health Home SPA is approved by OMB under control number 0938-1188 (CMS-
10434 #22, entitled: ``Health Home State Plan Amendment (SPA)'').
1. ICRs Regarding Attestation of Mandatory Reporting (Sec. 437.20(a))
The following changes will be submitted to OMB for their approval
under control number 0938-1188 (CMS-10434 #26 and CMS-10434 #22). As
noted previously in this final rule, we are changing the package under
which the Health Home Core Sets SPA preprint is associated from control
number 0938-1188 (CMS-10434 #47) to 0938-1188 (CMS-10434 #22, entitled:
``Health Home State Plan Amendment (SPA)'') as this package (CMS-10434
#22) is associated with the health home program State plan
requirements.
With the changes outlined in this final rule, the 50 States, DC,
Puerto Rico, Guam, and the Virgin Islands that will be subject to the
Child and Adult Core Sets reporting requirements will need to submit a
single SPA attesting that the agency will report on the Child and Adult
Core Sets in accordance with the requirements in Sec. 437.20(a). The
approximately 20 States (with approximately 40 health home programs)
with section 1945 Health Home SPAs and the approximately 10 States
estimated to apply for section 1945A Health Home SPAs would need to
submit a SPA attesting that the agency would report on the Health Home
Core Sets in accordance with the requirements in Sec. 437.20(a).
Health Home SPAs will also include an attestation that the State will
require its providers of health home services to report to the State on
the measures that the State has to report in accordance with the
requirements in Sec. 437.20(a).
We estimate it would take a business operations specialist 2 hours
at $80.08/hr and a general operations manager 1 hour at $118.14/hr to
update and submit the State or territory SPA to us for review. We
estimate a one-time burden of 162 hours (54 States and territories x 3
hr/response) at a cost of $15,028 (54 States and territories x ([2 hr/
response x $80.08/hr] + [1 hr/response x $118.14/hr])). Taking into
account the Federal contribution to Medicaid and CHIP program
administration, the estimated State share of this cost is approximately
$7,514 ($15,028 x 0.50). CMS is attributing \2/3\ of this burden
($5,009 State share and 108 hr) to Child and Adult Core Sets reporting
and \1/3\ to Health Home Core Sets reporting ($2,505 State share and 54
hr). CMS is attributing additional burden to Child and Adult Core Sets
reporting (versus Health Home Core Sets reporting) due to additional
effort to coordinate attestation of State Core Sets reporting across
State Medicaid and CHIP programs.
Table 2--Attestation Requirements and Burden Under OMB Control Number 0938-1188
[CMS-10434 #26, Child Core Set and the Adult Core Set]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Time per Adjusted cost
Regulatory section(s) under Number Total number response Total time (hr) Labor cost ($/hr) Total cost ($) (50% FMAP
Title 42 of the CFR respondents of responses (hr) ($) or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.20--One-time SPA 54 54 2 108 (162 hr x \2/3\)..... Varies............ 10,019 5,009
Submission *.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* States will be required to submit a SPA that attests that the State will be in compliance with Child, Adult, and Health Home Core Sets reporting.
Every State would complete the SPA and States with a Health Home would only have to identify as applicable.
Table 3--Attestation Requirements and Burden Under OMB Control Number 0938-1188
[CMS-10434 #22, Health Home SPA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Time per Adjusted cost
Regulatory section(s) under Number Total number response Total time (hr) Labor cost ($/hr) Total cost ($) (50% FMAP
Title 42 of the CFR respondents of responses (hr) ($) or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.20--One-time SPA 54 54 1 54 (162 hr x \1/3\)...... Varies............ 5,009 2,505
Submission *.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* States will be required to submit a SPA that attests that the State will be in compliance with Child, Adult, and Health Home Core Sets reporting.
Every State would complete the SPA and States with a Health Home would only have to identify as applicable.
[[Page 60307]]
2. ICRs Regarding Core Set of Children's Health Care Quality Measures
for Medicaid and CHIP (Child Core Set) (Part 437, Subpart A)
The following will be submitted to OMB for their approval under
control number 0938-1188 (CMS-10434 #26).
As required by section 50102(b) of the Bipartisan Budget Act of
2018, a new subparagraph (B) was added to section 1139A(a)(4) of the
Act to mandate annual reporting of the Child Core Set beginning with
the annual State report on FFY 2024. As referenced in section II.A. of
this final rule, mandatory reporting of the Child Core Set will be
required for all 50 States, DC, Puerto Rico, Guam, and the Virgin
Islands. The data collection, as explained in section II.C. of this
final rule, will be required to include: reporting on all mandatory
measures following the reporting guidance provided by CMS; populations,
identified by CMS, for which States must report on each measure such as
specified delivery systems, health care settings, and beneficiaries
dually eligible for Medicare and Medicaid; and the stratification of
certain measures by factors such as race, ethnicity, sex, age, rural/
urban status, disability and language.
The burden for each respondent is dependent on the State reporting
structure and the status of the State's Medicaid and CHIP programs.
Currently, there are 14 States and territories with Medicaid expansion
CHIP only, 2 States with separate CHIPs, and 38 States with both
Medicaid expansion and separate CHIPs.\63\ We expect the burden for
States with separate CHIPs or both types of CHIPs to be higher than for
States with Medicaid expansion CHIP only. This is because States with
separate CHIPs or both types of CHIPs would have to report data for
children enrolled across both Medicaid and CHIP. This would result in
more complex data sets and would require the State to conduct the
Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey
twice, once for Medicaid and once for CHIP.\64\ To account for the
added reporting and survey effort for States with separate CHIP or with
both Medicaid expansion and separate CHIPs, we have applied a
multiplier of 1.5 to the burden hours for Child Core Set measure
reporting and a multiplier of 2 to the burden estimate for conducting
and reporting CAHPS survey data.
---------------------------------------------------------------------------
\63\ https://www.medicaid.gov/chip/downloads/chip-map.pdf.
\64\ The Agency for Healthcare Research and Quality is the
measure steward for the CAHPS survey (CAHPS health plan database OMB
Control No.: 0935-0165).
---------------------------------------------------------------------------
For the 14 States with Medicaid expansion CHIP only, we expect that
the reporting of approximately 25 Child Core Set measures would take:
154 hours at $98.84/hr for a computer programmer to re-program and
synthesize the data; 20 hours at $101.46/hr for a statistician to
conduct data sampling; 115 hours at $118.14/hr for a general operations
manager to analyze the data; 216.5 hours at $37.94/hr for a data entry
worker to input the data; and 11.75 hours at $236.96/hr for a chief
executive to verify, certify, and approve a State data submission to
CMS.\65\ We estimate an annual burden of 7,242 hours (517.25 hr x 14
responses) at a cost of $585,689 (14 responses x ([154 hr x $98.84/hr]
+ [20 hr x $101.46/hr] + [115 hr x $118.14/hr] + [216.5 hr x $37.94/hr]
+ [11.75 hr x $236.96/hr])).
---------------------------------------------------------------------------
\65\ Child Core Set: https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html.
---------------------------------------------------------------------------
Additionally, we expect the new reporting mandate to require vendor
contract modifications in all 14 States. We expect the contract
modifications would take 6 hours at $118.14/hr for a general operations
manager to draft a vendor contract and 2 hours at $236.96/hr for a
chief executive to review and approve a modified vendor contract. We
estimate an annual burden of 112 hours (8 hr/response x 14 responses)
at a cost of $16,559 (14 responses x ([6 hr x $118.14/hr] + [2 hr x
$236.96/hr])).
In aggregate, for States with Medicaid expansion CHIP only, we
estimate an annual State burden of 7,354 hours (7,242 hr + 112 hr) at a
cost of $602,248 ($585,689 + $16,559). Taking into account the Federal
contribution to Medicaid and CHIP program administration, the estimated
State share of this cost is approximately $301,124 ($602,248 x 0.50).
For the 40 States (with separate CHIPs (2) and States with both
Medicaid Expansion and separate CHIPs (38)) we expect a higher burden,
because States with separate CHIP programs or combination CHIP programs
would have to report data for children enrolled across both Medicaid
and CHIP programs. We expect the Child Core Set of approximately 25
measures would take: 264.5 hours at $98.84/hr for a computer programmer
to collect and synthesize the data; 40 hours at $101.46/hr for a
statistician to conduct data sampling; 186.5 hours at $118.14/hr for a
general operations manager to analyze the data; 427.75 hours at $37.94/
hr for a data entry worker to input the data; and 18 hours at $236.96/
hr for a chief executive to verify, certify, and approve a State data
submission to CMS. We estimate an annual burden of 37,480 hours (937 hr
x 40 responses) at a cost of $2,909,152 (40 responses x ([264.5 hr x
$98.84/hr] + [40 hr x $101.46/hr] + [186.5 hr x $118.14/hr] + [427.75
hr x $37.94/hr] + [18 x $236.96/hr])).
Additionally, we expect the new reporting mandate would require
vendor contract modifications. We expect the contract modifications to
take 6 hours at $118.14/hr for a general operations manager to draft a
vendor contract and 2 hours at $236.96/hr for a chief executive to
review and approve a modified vendor contract. We estimate an annual
burden of 320 hours (8 hr x 40 responses) at a cost of $47,310 (40
responses x ([6 hr x $118.14/hr] + [2 hr x $236.96/hr])).
In aggregate, for States with separate CHIPs and States with both
Medicaid Expansion and separate CHIPs, we estimate an annual State
burden of 37,800 hours (37,480 hr + 320 hr) at a cost of $2,956,462
($2,909,152 + $47,310). Taking into account the Federal contribution to
Medicaid and CHIP program administration, the estimated State share of
this cost is approximately $1,478,231 ($2,956,462 x 0.50).
The CAHPS measure is the only mandatory measure on the Child Core
Set which would include a burden on beneficiaries. We estimate it would
take 20 minutes (0.33 hr) at $21.98/hr for a Medicaid or CHIP
beneficiary to complete the CAHPS Health Plan Survey (Child Core Set
includes: Child version including Medicaid and Children with Chronic
Conditions Supplemental Items). The collected survey data are
incorporated into a Child Core Set measure.
For the 14 States with Medicaid expansion CHIP programs only, the
survey will be conducted once each year. We estimate an annual per
State beneficiary burden of 136 hours (0.33 hr per response x 411
beneficiary responses/State x 1 survey/yr) at a cost of $2,989 (136 hr
x $21.98/hr).\66\ In aggregate, for States with Medicaid expansion CHIP
only, we estimate an annual beneficiary burden of 1,904 hours (136 hr x
14 States) at a cost of $41,846 ($2,989 x 14 States). We estimate a
total of 5,754 beneficiary
[[Page 60308]]
responses (14 States x 411 beneficiary responses).
---------------------------------------------------------------------------
\66\ Per CAHPS Health Plan Survey 5.1H Guidelines: The sample
needs to be large enough to achieve a goal of 411 completed surveys
per reporting unit (for example, health plan or State).
---------------------------------------------------------------------------
States with combination CHIP programs or separate CHIP program only
would conduct the survey twice each year to account for the separate
Medicaid and CHIP populations. There are 40 States and territories with
this program structure. We estimate an annual per State beneficiary
burden of 271 hours (0.33 hr per response x 411 beneficiary responses/
State x 2 surveys/yr) at a cost of $5,957 (271 hr x $21.98/hr).\67\ In
aggregate, for States with combination CHIP programs or separate CHIP
program only, we estimate an annual beneficiary burden of 10,840 hours
(271 hr x 40 States) at a cost of $238,280 ($5,957 x 40 States). We
estimate a total of 32,880 beneficiary responses (40 States x 411
beneficiary responses x 2 surveys/year).
---------------------------------------------------------------------------
\67\ Per CAHPS Health Plan Survey 5.1H Guidelines: The sample
needs to be large enough to achieve a goal of 411 completed surveys
per reporting unit (for example, health plan or State).
---------------------------------------------------------------------------
For States to administer the survey, we estimate an ongoing
aggregate beneficiary burden of 12,744 hours (1,904 + 10,840 hr) at a
cost of $280,126 ($41,846 + $238,280).
Table 4--Child Core Set Requirements and Burden Under OMB Control Number 0938-1188
(CMS-10434 #26, Child Core Set and the Adult Core Set)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Adjusted cost
Regulatory section(s) under Title 42 Number number of Time per response (hr) Total time Labor cost ($/hr) Total cost ($) (50% FMAP
of the CFR respondents responses (hr) ($) or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15--Medicaid Expansion 14 14 525.25................ 7,354 Varies................ 602,248 301,124
CHIP Programs.
Sec. 437.15--States with 40 40 945................... 37,800 Varies................ 2,956,462 1,478,231
combination CHIP programs or
separate CHIP programs only.
-------------------------------------------------------------------------------------------------------------------
Subtotal: States................ 54 54 Varies................ 45,154 Varies................ 3,558,710 1,779,355
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15--CAHPS survey: 5,754 5,754 0.33.................. 1,904 21.98................. 41,846 NA
Medicaid Expansion CHIP Programs.
Sec. 437.15--CAHPS survey: States 32,880 32,880 0.33.................. 10,840 21.98................. 238,280 NA
with combination CHIP programs or
separate CHIP programs only.
-------------------------------------------------------------------------------------------------------------------
Subtotal: CAHPS Survey 38,634 38,634 Varies................ 12,744 21.98................. 280,126 NA
beneficiary.
-------------------------------------------------------------------------------------------------------------------
Total....................... 38,688 38,688 Varies................ 57,898 Varies................ 3,838,836 1,779,355
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. ICRs Regarding Core Set of Adult Health Care Quality Measures for
Medicaid (Adult Core Set) (Part 437, Subpart A)
The following changes will be submitted to OMB for their approval
under control number 0938-1188 (CMS-10434 #26).
As required by the SUPPORT Act, a new subparagraph (b)(3)(B) was
added to section 1139B of the Act, to make mandatory the annual
reporting of behavioral health measures in the Adult Core Set beginning
with the annual State report on FFY 2024. As referenced in section
II.A. of this final rule, mandatory reporting of the Adult Core Set
will be required for all 50 States, DC, Puerto Rico, Guam, and the
Virgin Islands. The data collection, as explained in section II.C. of
this final rule, is required to include: reporting on all mandatory
measures following the reporting guidance provided by CMS; populations,
identified by CMS, for which States must report on each measure such as
specified delivery systems, health care settings, and beneficiaries
dually eligible for Medicare and Medicaid; and the stratification of
certain measures by factors such as race, ethnicity, sex, age, rural/
urban status, disability and language.
For the behavioral health measures on the Adult Core Set,
consisting of approximately 13 measures, we estimate it would take: 115
hours at $98.84/hr for a computer programmer to re-program and
synthesize the data; 20 hours at $101.46/hr for a statistician to
conduct data sampling; 76 hours at $118.14/hr for a general operations
manager to analyze the data; 212 hours at $37.94/hr for a data entry
worker to input the data; and 6.5 hours at $236.96/hr for a chief
executive to verify, certify, and approve a State data submission to
CMS.\68\ We estimate an annual burden of 23,193 hours (429.5 hr/
response x 54 responses) at a cost of $1,725,730 (54 responses x ([115
hr x $98.84/hr] + [20 hr x $101.46/hr] + [76 hr x $118.14/hr] + [212 hr
x $37.94/hr] + [6.5 x $236.96/hr])).
---------------------------------------------------------------------------
\68\ https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-care-quality-measures/index.html.
---------------------------------------------------------------------------
Additionally, we expect the new reporting mandate would require
vendor contract modifications. We expect the contract modifications to
take 6 hours at $118.14/hr for a general operations manager to draft a
vendor contract and 2 hours at $236.96/hr for a chief executive to
review and approve a modified vendor contract. We estimate a one-time
burden of 432 hours (8 hr x 54 responses) at a cost of $63,869 (54
responses x ([6 hr x $118.14/hr) + [2 hr x $236.96/hr])).
In aggregate, we estimate an annual State burden of 23,625 hours
(23,193 hr + 432 hr) at a cost of $1,789,599 ($1,725,730 + $63,869).
Taking into account the Federal contribution to Medicaid and CHIP
program administration, the estimated State share of this cost is
approximately $894,800 ($1,789,599 x 0.50).
The CAHPS measure is the only mandatory measure on the Adult Core
Set which would include a burden on beneficiaries.\69\ We estimate it
would take 20 minutes (0.33 hr) at $21.98/hr for a Medicaid beneficiary
to complete a CAHPS Health Plan survey. The collected survey data is
incorporated into one of the behavioral health measures on the Adult
Core Set. For each State Medicaid program, we estimate an annual per
State beneficiary burden of 136 hours (0.33 hr/response x 411
beneficiary responses/State) at a cost of $2,989 (136 hr x $21.98/
hr).\70\ For States to administer the survey, in aggregate, we estimate
an annual beneficiary burden of 7,344 hours (136 hr/State x 54 States)
at a cost of $161,406 ($2,989 per State x 54 States). We estimate a
total of 22,194 beneficiary
[[Page 60309]]
responses (54 States x 411 beneficiary responses).
---------------------------------------------------------------------------
\69\ The Agency for Healthcare Research and Quality is the
measure steward for the CAHPS survey (CAHPS health plan database OMB
Control No.: 0935-0165).
\70\ Per CAHPS Health Plan Survey 5.1H Guidelines: The sample
needs to be large enough to achieve a goal of 411 completed surveys
per reporting unit (for example, health plan or State).
Table 5--Adult Core Set Requirements and Burden Under OMB Control Number 0938-1188
[CMS-10434 #26, Child Core Set and the Adult Core Set]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted
Regulatory section(s) under Total Time per response Total time Total cost cost ($)
Title 42 of the CFR Number respondents number of (hr) (hr) Labor cost ($/hr) ($) (50% FMAP
responses or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15--(Adult Core Set) 54 States............ 54 437.5................ 23,625 Varies............... 1,789,599 894,800
States.
Sec. 437.15--CAHPS Survey 22,194............... 22,194 0.33................. 7,344 21.98................ 161,406 NA
(Beneficiaries).
------------------------------------------------------------------------------------------------------------------------
Total...................... 22,248............... 22,248 Varies............... 30,969 Varies............... 1,951,005 894,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. ICRs Regarding Core Sets of Health Home Quality Measures for
Medicaid (Health Home Core Sets) (Part 437, Subpart A)
The following changes will be submitted to OMB for their approval
under control number 0938-1188 (CMS-10434 #47). The burden associated
with health home providers submitting data to the States is not
included in this ICR as the burden estimate for the 1945 and 1945A
health home programs is already included in control number 0938-1188
(CMS-10434 # 22). Including the provider burden in this estimate would
be duplicative.
Sections 1945(g) and 1945A(g)(1)(B) of the Act require health home
providers to report to States on measures for determining the quality
of health home services provided, as a condition for payment of such
services. Sections 1945(c)(4)(B) and 1945A(g)(2) of the Act require
States to report on certain health home information to the Secretary,
and we rely on these authorities, as well as on section 1902(a)(6) of
the Act, in proposing to require all States implementing the section
1945 or section 1945A health home benefits to report on mandatory
measures in the Health Home Core Sets. Additionally, to enable this
State reporting, States will be required to require their health home
providers to report on these measures too, consistent with sections
1945(g) and 1945A(g)(1)(B) of the Act. As discussed in section II.A. of
this final rule, State reporting of the Health Home Core Sets would be
required only if the State (as defined in section 1101 for purposes of
Title XIX) has an approved health home SPA under sections 1945 or 1945A
of the Act. The data collection, as explained in section II.C. of this
final rule, will be required to include: reporting on all mandatory
measures following the reporting guidance provided by CMS; all
beneficiaries served in each State's relevant health home program; and
the stratification of data under certain measures by factors such as
race, ethnicity, sex, age, rural/urban status, disability and language.
The burden for each respondent is dependent on the State's adoption
of Health Home programs. We expect approximately 20 States to operate
approximately 40 Health Home programs under section 1945 authority and
approximately 10 States to operate Health Home programs under section
1945A authority.
Section 1945 Authority: The section 1945 Health Home Core Set for
section 1945 programs consists of approximately 13 measures. For each
respondent with this program, we estimate it would take: 52 hours at
$98.84/hr for a computer programmer to collect and synthesize the data;
52 hours at $118.14/hr for a general operations manager to analyze the
data; 6.5 hours at $37.94/hr for a data entry worker to input the data;
and 6.5 hours at $236.96/hr for a chief executive to verify, certify,
and approve a State data submission to CMS. We estimate an annual
burden of 4,680 hours (117 hr x 40 responses) at a cost of $522,792 (40
responses x ([52 hr x $98.84/hr] + [52 hr x $118.14/hr] + [6.5 hr x
$37.94/hr] + [6.5 x $236.96/hr])).
Additionally, we expect the new reporting mandate would require
vendor contract modifications. We expect the contract modifications to
take 6 hours at $118.14/hr for a general operations manager to draft a
vendor contract and 2 hours at $236.96/hr for a chief executive to
review and approve a modified vendor contract. We estimate a one-time
burden of 320 hours (8 hr x 40 responses) at a cost of $47,310 (40
responses x ([6 hr x $118.14/hr) + [2 hr x $236.96/hr])).
In aggregate, for States with a 1945 health home program, we
estimate an annual burden of 5,000 hours (4,680 hr + 320 hr) at a cost
of $570,103 ($522,792 + $47,310). Taking into account the Federal
contribution to Medicaid program administration, the estimated State
share of this cost is approximately $285,052 ($570,103 x 0.50).
Note that the section 1945 Health Home Core Set does not include a
survey-based measure; thus, there are no burden and cost estimates
associated with a survey, such as the costs of a statistician to
conduct sampling and weighting for the survey.
Table 6--1945 Adult Core Set Requirements and Burden Under OMB Control Number 0938-1188
[CMS-10434 #47, Health Home Core Sets]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted
Regulatory section(s) under Title 42 Number Total number Time per Total time Total cost cost ($)
of the CFR respondents of responses response (hr) Labor cost ($/hr) ($) (50% FMAP or
(hr) FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15--(1945 Health Home Core 40 40 125 5,000 Varies...................... 570,103 285,052
Set).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 1945A Authority: We anticipate that the section 1945A
Health Home Core Set for section 1945A programs would consist of
approximately 7 measures. For each respondent with this program, we
estimate it would take: 28 hours at $98.84/hr for a computer programmer
to collect and synthesize the data; 28 hours at $118.14/hr for a
general operations manager to analyze the data; 3 hours at $37.94/hr
for a data entry worker to
[[Page 60310]]
input the data; and 3 hours at $236.96/hr for a chief executive to
verify, certify, and approve a State data submission to us. We estimate
an annual State burden of 620 hours (62 hr/response x 10 responses) at
a cost of $69,001 (10 responses x ([28 hr x $98.84/hr] + [28 hr x
$118.14/hr] + [3 hr x $37.94/hr] + [3 x $236.96/hr])).
Additionally, we expect the new reporting mandate would require
vendor contract modifications. We expect the contract modifications to
take 6 hours at $118.14/hr for a general operations manager to draft a
vendor contract and 2 hours at $236.96/hr for a chief executive to
review and approve a modified vendor contract. We estimate a one-time
burden of 80 hours (8 hr x 10 responses) at a cost of $11,828 (10
responses x ([6 hr x $118.14/hr) + [2 hr x $236.96/hr])).
In aggregate, for States with a 1945A health home program, we
estimate an annual State burden of 700 hours (620 hr + 80 hr) at a cost
of $80,829 ($69,001 + $11,828). Taking into account the Federal
contribution to Medicaid program administration, the estimated State
share of this cost is approximately $40,415 ($80,829 x 0.50).
Note that we anticipate that the section 1945A Health Home Core Set
would not include a survey-based measure; thus, there are no burden and
cost estimates associated with a survey, such as the costs of a
statistician to conduct sampling and weighting for the survey.
Table 7--1945A Adult Core Set Requirements and Burden Under OMB Control Number 0938-1188
[CMS-10434 #47, Health Home Core Sets]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted
Regulatory section(s) under Title 42 Number Total number Time per Total time Total cost cost ($)
of the CFR respondents of responses response (hr) Labor cost ($/hr) ($) (50% FMAP or
(hr) FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15--(1945A Health Home Core 10 10 70 700 Varies...................... 80,829 40,415
Set).
--------------------------------------------------------------------------------------------------------------------------------------------------------
5. ICRs Regarding Optional Request for Exemption From Mandatory Child
and Adult Core Sets Reporting for Specific Populations (Child and Adult
Core Sets (Part 437, Subpart A))
With the changes outlined in this final rule, the 50 States, DC,
Puerto Rico, Guam, and the Virgin Islands that will be subject to the
Child and Adult Core Sets reporting requirements will have an
opportunity each year to request a 1-year exemption from reporting data
for one or more mandatory populations for the Child and Adult Core Sets
if the State demonstrates an inability to obtain access to data
required to report on the Child and Adult Core Sets in accordance with
the requirements in Sec. Sec. 437.10(b)(5), 437.15(a)(4)(ii), and (6).
We have added this option to address concerns about the feasibility of
Child and Adult Core Sets reporting for specific populations. A State
that needs an exemption must request the exemption from CMS by
September 1st of the applicable reporting year, the exemption would be
only for that year's reporting, and it would apply only to the specific
population for which the State receives an exemption for reporting that
population in one or more measures. The State would be required to
define the specific population for which exemption from reporting is
sought and to which measure(s) the request applies. The State will be
required to explain why this exemption is necessary (that is, why the
State agency was not able to obtain access to the data required to
report on the relevant population) and what actions are underway to
resolve the data access problems. In addition, the State must
demonstrate to us that it has made a reasonable effort to obtain the
required data by the reporting deadline. As discussed previously in
this final rule, we will solicit public comment via 60-day and 30-day
Paperwork Reduction Act notices that we will issue in the Federal
Register separate from this rulemaking document before this voluntary
requirement takes effect September 1, 2024.
The process to request an exemption from reporting one or more
mandatory populations for the Child and Adult Core Sets will require
the state to submit an exemption request to us. We estimate it would
take a business operations specialist 1 hour at $80.08/hr to determine
which populations the state is unable to report, a general operation
manager 2 hours at $118.14/hr to draft an exemption request and 1 hour
at $236.96/hr for a chief executive to review, approve, and submit the
exemption request. We estimate an annual burden of 216 hours (54 States
and territories x 4 hr/response) at a cost of $29,879 (54 States and
territories x ([1 hr/response x $80.08/hr] + [2 hr/response x $118.14/
hr]) + [1 hr/response x $236.96/hr])). Taking into account the Federal
contribution to Medicaid and CHIP program administration, the estimated
State share of this cost is approximately $14,940 ($29,879 x 0.50).
Table 8--Request for Exemption From Reporting Specific Populations
[Child/Adult Core Sets only]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Time per Adjusted cost
Regulatory section(s) under Title Number Total number response Total time (hr) Labor cost ($/hr) Total cost ($) (50% FMAP
42 of the CFR respondents of responses (hr) ($) or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15(a)(6)--Annual 54 54 4 216 hrs.............. Varies.............. 29,879 14,940
Exemption Request *.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* States will have the option to submit a request for exemption from reporting one or more mandatory populations. Exemption requests only apply to Child
and Adult Core Sets reporting.
C. Summary of Annual Requirements and Annual Burden Estimates
As stated in section II. of this final rule, we received 93 public
comments on the proposed rule, but only one of those comments was
related to the rule's collection of information requirements.
Comment: One commenter noted that in their experience with the
Child and Adult Core Sets, the time to convert the reporting guidance
into analytic code is underestimated in the COI (by 3-4 times) and the
time to input the data is an overestimate.
[[Page 60311]]
Response: As the COI estimate reflects the average costs for all
States that are required to comply with mandatory Core Set reporting
requirements, it is expected that there will be variation in time
estimates experienced by individual States. Upon additional review, we
have revised the COI estimate for the Child and Adult Core Sets to
reflect the issue raised by this public comment and added additional
time to program, synthesize, analyze, and review the data. We are
working with States to develop strategies to reduce the burden of
implementing reporting guidance and for FFY 2021 reporting introduced a
new reporting system to help reduce the burden of Core Set reporting.
We will continue to work with States to identify best practices and
strategies to further reduce this burden and incorporate this
information into reporting guidance and technical assistance materials.
Table 9 sets out our annual burden estimates.
Table 9--Summary of Annual Requirements and Burden
[OMB Control Number: 0938-1188]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted cost
Section 437 under Title 42 of the Number of Total Time per response Total time Labor cost ($/hr) Total cost ($) (50% FMAP
CFR respondents responses (hours) (hours) ($) or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CMS-10434 #26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.20--One-time SPA 54.................. 54 2.................. 108 Varies............. 10,019 5,009
Submission *.
Sec. 437.15--Medicaid Expansion 14.................. 14 525.25............. 7,354 Varies............. 602,248 301,124
CHIP Programs.
Sec. 437.15--CAHPS survey: 5,754............... 5,754 0.33............... 1,904 21.98.............. 41,846 NA
Medicaid Expansion CHIP Programs.
Sec. 437.15--States with 40.................. 40 945................ 37,800 Varies............. 2,956,462 1,478,231
combination CHIP programs or
separate CHIP programs only.
Sec. 437.15--CAHPS survey: 32,880.............. 32,880 0.33............... 10,840 21.98.............. 238,280 NA
States with combination CHIP
programs or separate CHIP
programs only.
Sec. 437.15--(Adult Core Set).. 54.................. 54 437.5.............. 23,625 Varies............. 1,789,599 894,800
Sec. 437.15--CAHPS: (Adult Core 22,194.............. 22,194 0.33............... 7,344 21.98.............. 161,406 NA
Set).
----------------------------------------------------------------------------------------------------------------------
Subtotal (#26)............... .................... 60,990 Varies............. 88,975 Varies............. 5,799,860 2,679,164
--------------------------------------------------------------------------------------------------------------------------------------------------------
CMS-10434 #22
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.20--One-time SPA 54.................. 54 1.................. 54 Varies............. 5,009 2,505
Submission *.
----------------------------------------------------------------------------------------------------------------------
Subtotal (#22)............... 54.................. 54 1.................. 54 Varies............. 5,009 2,505
--------------------------------------------------------------------------------------------------------------------------------------------------------
CMS-10434 #47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15--(1945 Health Home 40.................. 40 125................ 5,000 Varies............. 570,103 285,052
Core Set).
Sec. 437.15--(1945A Health Home 10.................. 10 70................. 700 Varies............. 80,829 40,415
Core Set).
----------------------------------------------------------------------------------------------------------------------
Subtotal (#47)............... 50.................. 50 Varies............. 5,700 Varies............. 650,932 325,467
--------------------------------------------------------------------------------------------------------------------------------------------------------
CMS-10867
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 437.15(a)(6)--Annual 54.................. 54 4.................. 216 Varies............. 29,879 14,940
Exemption Request *.
----------------------------------------------------------------------------------------------------------------------
Total.................... Varies.............. 61,148 Varies............. 94,945 Varies............. 6,485,680 3,022,076
--------------------------------------------------------------------------------------------------------------------------------------------------------
* States will be required to submit a SPA that attests that the State will be in compliance with Child, Adult, and Health Home Core Sets reporting.
Every State would complete the SPA and States with a Health Home would only have to identify as applicable.
IV. Regulatory Impact Statement
We have examined the impact 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), Executive Order 14094 on Modernizing Regulatory
Review (April 6, 2023), 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 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 as amended by Executive Order 14094 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 $200 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;
(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 legal
or policy issues for which centralized review would meaningfully
further the President's priorities, or the principles set forth in the
Executive Order. OIRA has determined that this final rule is
significant, and it was accordingly reviewed by OMB.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, small pharmaceutical
manufacturers participating in the Medicaid Drug Rebate Program, and
small governmental jurisdictions. Most hospitals and most other
providers and suppliers are small entities, either by nonprofit status
or by having revenues of less than $8.0 million to $41.5 million in any
1 year. Individuals and States are not included in the definition
[[Page 60312]]
of a small entity. This final rule applies to new mandatory reporting
requirements for information collection from State Medicaid and CHIP
agencies who do not meet the definition of a small business. Therefore,
we are not preparing an analysis for the RFA because we have
determined, and the Secretary certifies, that this final rule would not
have a significant economic impact on any small entities. In addition,
section 1102(b) of the Act requires us to prepare an RIA if a rule may
have a significant impact on the operations of a substantial number of
small rural hospitals. This analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a Metropolitan Statistical Area for Medicare payment regulations and
has fewer than 100 beds. This proposed rule applies to State Medicaid
and CHIP agencies and would not add requirements to rural hospitals or
other small providers. Therefore, we are not preparing an analysis for
section 1102(b) of the Act because we have determined, and the
Secretary certifies, that this final rule would not have a significant
impact on the operations of small rural hospitals. Section 202 of the
Unfunded Mandates Reform Act of 1995 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 2023, that threshold is approximately $177
million. This rule would have no consequential effect on State, local,
or tribal governments or on the private sector. Executive Order 13132
establishes certain requirements that an agency must meet when it
issues a proposed rule (and subsequent final rule) that imposes
substantial direct compliance costs on State and local governments,
preempts State law, or otherwise has federalism implications. Since
this regulation does not impose any substantial direct compliance costs
on State or local governments, preempt State law, or otherwise have
federalism implications, the requirements of Executive Order 13132 are
not applicable. In accordance with the provisions of Executive Order
12866, this regulation was reviewed by the Office of Management and
Budget.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on August 23, 2023.
List of Subjects
42 CFR Part 433
Administrative practice and procedure, Child support, Claims, Grant
programs--health, Medicaid, Reporting and recordkeeping requirements.
42 CFR Part 437
Administrative practice and procedure, Claims, Grant programs--
health, Medicaid, Reporting and recordkeeping requirements.
42 CFR Part 457
Administrative practice and procedure, Grant programs-health,
Health insurance, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 433--STATE FISCAL ADMINISTRATION
0
1. The authority citation for part 433 continues to read as follows:
Authority: 42 U.S.C. 1302.
0
2. Amend Sec. 433.112 by revising paragraph (b)(12) to read as
follows:
Sec. 433.112 FFP for design, development, installation or enhancement
of mechanized processing and information retrieval systems.
* * * * *
(b) * * *
(12) The agency ensures alignment with, and incorporation of,
standards and implementation specifications for health information
technology adopted by the Office of the National Coordinator for Health
IT in 45 CFR part 170, subpart B. The agency also ensures alignment
with: the HIPAA privacy, security, breach notification and enforcement
regulations in 45 CFR parts 160 and 164; and the transaction standards
and operating rules adopted by the Secretary under HIPAA and/or section
1104 of the Affordable Care Act. The agency meets accessibility
standards established under section 508 of the Rehabilitation Act, or
standards that provide greater accessibility for individuals with
disabilities, and compliance with Federal civil rights laws; standards
and protocols adopted by the Secretary under section 1561 of the
Affordable Care Act; standards and protocols for reporting on the Child
and Adult Core Sets as adopted by the Secretary under sections 1139A,
1139B, and 1902(a)(6) of the Act, and 42 CFR part 437 subpart A; and
standards and protocols for reporting on the Health Home Core Sets as
adopted by the Secretary under sections 1902(a)(6), 1945(c)(4)(B) and
(g), and 1945A(g) of the Act and 42 CFR part 437 subpart A.
* * * * *
0
3. Part 437 is added to read as follows:
PART 437--MEDICAID QUALITY
Subpart A--Child, Adult, and Health Home Health Care Quality Measures
Sec.
437.1 Basis, scope, purpose, and applicability.
437.5 Definitions.
437.10 Child, Adult, and Health Home Core Sets.
437.15 Annual reporting on the Child, Adult, and Health Home Core
Sets.
437.20 State plan requirements.
Subpart B [Reserved]
Authority: 42 U.S.C. 1320b-9a, 42 U.S.C. 1320b-9b, 42 U.S.C.
1396a(a)(6), 42 U.S.C. 1396w-4, and 42 U.S.C. 1396w-4a.
Subpart A--Child, Adult, and Health Home Health Care Quality
Measures
Sec. 437.1 Basis, scope, purpose, and applicability.
(a) Statutory basis. This subpart is based on sections 1139A,
1139B, 1902(a)(6), 1945(c)(4)(B), 1945(g), and 1945A(g) of the Act.
(b) Scope. This subpart sets forth specifications for issuance and
updates to the Core Set of Children's Health Care Quality Measures for
Medicaid and CHIP (Child Core Set), the Core Set of Adult Health Care
Quality Measures for Medicaid (Adult Core Set), and the 1945 and 1945A
Core Sets of Health Home Quality Measures for Medicaid (Health Home
Core Sets) by the Secretary. It also sets forth requirements related to
annual reporting by States of measures in all of the Core Sets, and
requirements related to provider reporting to States on the Health Home
Core Sets.
(c) Purpose. (1) The purpose of the Medicaid and CHIP Child Core
Set and the Medicaid Adult Core Set is to measure the overall national
quality of care for beneficiaries, monitor performance at the State-
level, and improve the quality of health care.
(2) The purpose of the Health Home Core Sets is to measure the
overall program quality of health home services for Medicaid
beneficiaries enrolled in a health home program under section 1945 or
1945A of the Act, monitor the impact of these two optional State plan
benefits, monitor performance of these two benefits at the program
level, and improve the quality of health care.
(d) Applicability. The provisions of this subpart apply as follows:
(1) For the Child and Adult Core Sets, State includes the 50
States, the District
[[Page 60313]]
of Columbia, Puerto Rico, the Virgin Islands, and Guam.
(2) For the Health Home Core Sets, State includes any State (as
defined under section 1101 of the Act for purposes of Title XIX of the
Act) with an approved Medicaid Health Home State Plan Amendment under
section 1945 or 1945A of the Act.
(e) Applicability dates. States must comply with the requirements
of this subpart by no later than State reporting on the 2024 Core Sets,
which must be submitted and certified by December 31, 2024.
Sec. 437.5 Definitions.
As used in this subpart--
1945 Health Home Core Set means the Core Set of Health Home Quality
Measures related to the Medicaid health home benefit under section 1945
of the Act, established and updated annually as described in Sec.
437.10(a).
1945A Health Home Core Set means the Core Set of Health Home
Quality Measures related to the Medicaid health home benefit under
section 1945A of the Act, established and updated annually as described
in Sec. 437.10(a).
Adult Core Set means the Core Set of Adult Health Care Quality
Measures for Medicaid established and updated annually as described in
Sec. 437.10(a).
Attribution rules means the process Medicaid and CHIP and other
payers use to assign beneficiaries to a specific health care program or
delivery system for the purpose of calculating the measures on the Core
Sets.
Behavioral health means a beneficiary's whole emotional and mental
well-being, which includes, but is not limited to, the prevention,
treatment, and recovery of mental disorders including substance use
disorders.
Behavioral health measure means a quality measure that could be
used to evaluate the quality of and improve the health care provided to
beneficiaries with, or at-risk for a behavioral health disorder(s).
Child Core Set means the Core Set of Health Care Quality Measures
for Children in Medicaid and CHIP, established and updated annually as
described in Sec. 437.10(a).
Core Sets means the Child Core Set, the Adult Core Set, the section
1945 Health Home Core Set, and the section 1945A Health Home Core Set,
collectively.
Health Home Core Sets means, collectively, the two Core Sets of
Health Home Quality Measures related to the two Medicaid health home
benefits under sections 1945 and 1945A of the Act, established and
updated annually as described in Sec. 437.10(a).
Standardized format means the format provided by the reporting
system that States are required to utilize to submit Core Sets data to
CMS.
Sec. 437.10 Child, Adult, and Health Home Core Sets.
(a) The Secretary shall--
(1) Identify, and annually update, the quality measures to be
included in the Child, Adult, and Health Home Core Sets; and update the
Child and Adult Core Sets beginning no later than January 1, 2024 and
annually no later than January 1 thereafter.
(2) Consult annually with States and other interested parties
identified in paragraph (e) of this section to--
(i) Establish priorities for the development and advancement of the
Core Sets;
(ii) Identify any gaps in the measures included in the Core Sets;
(iii) Identify measures which should be removed as they no longer
strengthen the Core Sets; and
(iv) Ensure that all measures included in the Core Sets reflect an
evidence-based process including testing, validation, and consensus
among interested parties; are meaningful for States; and are feasible
for State-level and/or Health Home program level reporting, as
appropriate.
(3) In consultation with States, develop and update annually the
reporting guidance described in paragraph (b) of this section.
(4) Not later than September 30, 2025 and annually by September 30
thereafter, collect, analyze, and make publicly available the
information reported by States on the Child and Adult Core Sets as
described in Sec. 437.15.
(5) Annually, collect, analyze, and make publicly available the
information reported by States on the Health Home Core Sets as
described in Sec. 437.15.
(b) Annual reporting guidance will include all of the following:
(1) Identification of all measures in all the Core Sets, including:
(i) Measures newly added and measures removed from the prior year's
Core Sets;
(ii) Measures included in the Adult Core Set that are identified as
behavioral health measures;
(iii) The specific measures for which reporting is mandatory for
the Child, Adult, and 1945 and 1945A Health Home Core Sets;
(iv) The measures for which the Secretary will complete reporting
on behalf of States and the measures for which States may elect to have
the Secretary report on their behalf; and
(v) The frequency of reporting for survey-based measures, which
will be no more frequent than annually.
(2) Guidance to States on how to collect and calculate the data on
the Core Sets.
(3) Standardized format for reporting measure data required under
this subpart.
(4) Procedures that State agencies must follow in reporting measure
data required under this subpart.
(5) Identification of the populations for which States may, but are
not required to, report the Child and Adult Core Set measures
identified by the Secretary under paragraph (b)(1) of this section for
a specific year in accordance with paragraph (c) of this section.
(i) Additionally, CMS will include guidance to States on how to
request a 1-year exemption from reporting one or more Child and/or
Adult Core Set measures for specific populations in accordance with
Sec. 437.15(a)(4)(ii) and (6) of this part.
(ii) [Reserved]
(6) Attribution rules for determining how States must report on
measures for beneficiaries who are included in more than one
population, during the reporting period.
(7) The subset of measures within the measures in the Child Core
Set, among the behavioral health measures in the Adult Core Set, and
among the measures in the Health Home Core Sets that must be stratified
by race, ethnicity, sex, age, rural/urban status, disability, language,
or such other factors as may be specified by the Secretary and informed
by annual consultation with States and interested parties in accordance
with paragraphs (a)(2) and (d) of this section.
(c) In issuing the guidance described in paragraph (b) of this
section, the Secretary may provide that Child and Adult Core Sets
reporting for certain populations of beneficiaries described in
paragraph (b)(5) of this section will be voluntary for a specific year,
considering the level of difficulty in accessing the data required for
such Child and Adult Core Sets State reporting.
(d) In specifying which measures, and by which factors, States must
report stratified measures consistent with paragraph (b)(7) of this
section, the Secretary will consider whether stratification can be
accomplished based on valid statistical methods and without risking a
violation of beneficiary privacy and, for measures obtained from
surveys, whether the original survey instrument collects the variables
necessary to stratify the measures, and such other factors as the
Secretary determines appropriate; the Secretary
[[Page 60314]]
will require stratification of 25 percent of the measures on each of
the Core Sets (the Child Core Set, behavioral health measures within
the Adult Core Set, and Health Home Core Sets) for which the Secretary
has specified that reporting should be stratified by the second year of
annual reporting after the effective date of these regulations, 50
percent of such measures for the third and fourth years of annual
reporting after the effective date of these regulations, and 100
percent of measures beginning in the fifth year of annual reporting
after the effective date of these regulations.
(e) For purposes of paragraph (a)(2) of this section, the Secretary
must consult with interested parties as described in this paragraph to
include the following:
(1) States;
(2) Pediatricians, children's hospitals, and other primary and
specialized pediatric health care professionals (including members of
the allied health professions) who specialize in the care and treatment
of children and adolescents, particularly children with special
physical, mental, and developmental health care needs;
(3) Dental professionals, including pediatric dental professionals;
(4) Health care providers that furnish primary health care to
children and families who live in urban and rural medically underserved
communities or who are members of distinct population sub-groups at
heightened risk for poor health outcomes;
(5) National organizations representing children and/or
adolescents, including children with disabilities and children with
chronic conditions;
(6) National organizations representing consumers and purchasers of
children's health care;
(7) National organizations and individuals with expertise in
pediatric health quality measurement;
(8) Voluntary consensus standards setting organizations and other
organizations involved in the advancement of evidence-based measures of
health care;
(9) With respect only to guidance on the Health Home Core Sets,
providers of health home services under sections 1945 and 1945A of the
Act;
(10) Such other interested parties as the Secretary may determine
appropriate.
Sec. 437.15 Annual reporting on the Child, Adult, and Health Home
Core Sets.
(a) General rules. (1) Except as provided in paragraphs (a)(2) and
(a)(4) of this section, the agency--
(i) Must report by December 31, 2024, on all measures on the 2024
Child Core Set and the behavioral health measures in the Adult Core
Set;
(ii) In subsequent years, must report annually, by December 31st,
on all measures on the Child Core Set and the behavioral health
measures in the Adult Core Set that are identified by the Secretary
pursuant to Sec. 437.10(b)(1)(iii);
(iii) Must report annually, by December 31st, on all measures in
the 1945 or 1945A Health Home Core Sets (as applicable) that are
identified by the Secretary pursuant to Sec. 437.10(b)(1)(iii), if the
agency has elected to offer health home services under the State plan
under section 1945 or section 1945A of the Act, and if the applicable
health home program has an effective date and has been implemented more
than 6 months prior to the December 31st reporting deadline; and
(iv) May report on all other measures in the Adult Core Set that
are not described in paragraphs (a)(1)(i) and (ii) of this section.
(2) Measures identified per Sec. 437.10(b)(1)(iv) will be reported
by the Secretary on behalf of the agency.
(3) The agency must adhere to the reporting guidance described in
Sec. 437.10(b), except as described in paragraph (a)(4) of this
section, when reporting on measures in the Core Sets.
(4) In reporting on all Child and Adult Core Set measures, the
agency is required to report on all Medicaid and CHIP beneficiaries,
including those enrolled in fee-for-service and managed care, unless--
(i) The Secretary specifies in annual guidance that the population
is not required to be reported in accordance with Sec. 437.10(b)(5);
or
(ii) The Secretary grants the agency an exemption from reporting
one or more Child and Adult Core Set measures for a specific population
in accordance with paragraph (a)(6) of this section.
(5) In reporting on all 1945 and 1945A Health Home Core Sets
measures, the agency is required to report on all beneficiaries
enrolled in an approved health home program.
(6)(i) The agency may request a 1-year exemption from reporting for
a specific population defined by the State for one or more Child and/or
Adult Core Set measures if the agency demonstrates that it:
(A) Is unable to obtain access to data required to report the
relevant Child and Adult Core Set measure or measures for that
population despite making reasonable efforts to do so; and
(B) Has a reasonable timeline of actions underway to resolve data
access problems.
(ii) The agency must submit a request for an exemption by September
1st of the applicable reporting year.
(iii) If the Secretary determines that the agency satisfies the
conditions set forth in paragraph (6)(i) of this section, the Secretary
will approve the exemption only for that year's Child and/or Adult Core
Set reporting and the exemption will apply only for the specific
population for which the State requests an exemption. If the Secretary
determines that the agency does not satisfy the conditions set forth in
paragraph (a)(6)(i) of this section, the Secretary will communicate a
denial of the exemption request to the agency, and the agency will be
expected to include the relevant population in that year's Child and
Adult Core Sets reporting.
(iv) The agency may request an exemption to reporting Child and
Adult Core Set measures for the same population in accordance with this
paragraph in more than one reporting year.
(b) Reporting of Medicaid and CHIP beneficiaries. In States that
have implemented a separate child health program (``separate CHIP'')
under part 457 of this chapter:
(1) The agency must report, in accordance with attribution rules
established by the Secretary pursuant to Sec. 437.10(b)(6), on
measures included in the Child Core Set for--
(i) The Medicaid beneficiaries (including those for whom the State
claims Federal financial participation under both Title XIX and Title
XXI) in the age range to which the measure applies, as per reporting
guidance described in paragraph Sec. 437.10(b)(2); and
(ii) The beneficiaries in the State's separate CHIP in the age
range to which the measure applies, as per reporting guidance described
in paragraph Sec. 437.10(b)(2).
(2) If the separate CHIP elects to report on Adult Core Set
measures for individuals enrolled in their separate CHIP, the agency
must report on individuals described in paragraphs (b)(1)(i) and (ii)
of this section.
Sec. 437.20 State plan requirements.
(a) The State plan must specify that:
(1) The agency will report on the Child and Adult Core Sets in
accordance with Sec. 437.15.
(2) If health home services are covered under the State plan
pursuant to section 1945 or 1945A of the Act, the agency will report on
the applicable Health Home Core Set or Sets in accordance with Sec.
437.15 of this subpart.
[[Page 60315]]
(3) If health home services are covered under the State plan
pursuant to section 1945 or 1945A of the Act, the agency requires
health home services providers to report to the agency on all
populations served by the health home providers and on the measures in
the applicable Health Home Core Set or Sets that are identified by the
Secretary pursuant to Sec. 437.10(b)(1)(iii), as a condition for
receiving payment for health home services.
(b) [Reserved]
PART 457--ALLOTMENTS AND GRANTS TO STATES
0
4. The authority citation for part 457 continues to read as follows:
Authority: 42 U.S.C. 1302.
0
5. Amend Sec. 457.700 by
0
a. In paragraph (a)(2) removing the word ``and'' at the end of the
paragraph;
0
b. In paragraph (a)(3) by removing the period at the end of the
paragraph and replacing it with ``; and''; and
0
c. Adding paragraph (a)(4).
The addition reads as follows:
Sec. 457.700 Basis, scope, and applicability.
* * * * *
(a) * * *
(4) Section 1139A and 1139B of the Act, which set forth the
requirements for child and adult health quality measures and reporting.
* * * * *
0
6. Add Sec. 457.770 to read as follows:
Sec. 457.770 Reporting on Health Care Quality Measures.
(a) Reporting the Child Core Set. The State must report on the Core
Set of Health Care Quality Measures for Children in Medicaid and CHIP
(Child Core Set) for a separate child health program in accordance with
part 437 of this chapter.
(b) Reporting the Adult Core Set. The State may elect to report on
the Core Set of Adult Health Care Quality Measures in Medicaid (Adult
Core Set) established by the Secretary in accordance with part 437 of
this chapter. If the State reports measures on the Adult Core Set, such
reporting must be in accordance with part 437 of this chapter, except
that reporting on behavioral health measures on the Adult Core Set is
not mandatory.
(c) Reporting of Medicaid and CHIP beneficiaries. The State must
report measures included in the Child Core Set and, if applicable,
Adult Core Set for individuals enrolled in a separate CHIP separately
from individuals enrolled in Medicaid in accordance with Sec.
437.15(b) of this chapter, regardless of whether the State claims
Federal financial participation for such Medicaid-enrolled individuals
under title XIX or title XXI of the Act.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-18669 Filed 8-28-23; 4:15 pm]
BILLING CODE 4120-01-P
