[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





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Centers for Medicare & Medicaid Services





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42 CFR Parts 433, 437, and 457





Medicaid 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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \17\ CMS Behavioral Health Strategy: https://www.cms.gov/cms-behavioral-health-strategy.
---------------------------------------------------------------------------

    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.''
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \20\ https://www.medicaid.gov/medicaid/quality-of-care/downloads/annual-core-set-review-11102022.pdf.
    \21\ https://www.mathematica.org/features/maccoresetreview.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \22\ https://www.medicaid.gov/medicaid/access-care/index.html.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \26\ https://www.cms.gov/files/document/2024-advance-notice-pdf.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \30\ To join the Core Set listserv email: 
[email protected].
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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/.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \34\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \35\ Technical Assistance Fact Sheet: https://www.medicaid.gov/medicaid/quality-of-care/downloads/tafactsheet.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \41\ CMS Cell Suppression Policy: https://www.hhs.gov/guidance/document/cms-cell-suppression-policy.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \49\ https://aspe.hhs.gov/reports/gaps-strategies-improving-american-indianalaska-nativenative-american-data#TOC.
    \50\ https://www.gao.gov/products/gao-22-104698.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \52\ Fact Sheet 2012: https://www.medicaid.gov/medicaid/quality-of-care/downloads/cahpsfactsheet.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \58\ See section 1905(ff) of the Act.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \59\ https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//176806/VOT.pdf.
    \60\ https://fred.stlouisfed.org/series/LEU0252881500A.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \61\ Core Set Measure lists: https://www.medicaid.gov/medicaid/quality-of-care/index.html.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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