[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Proposed Rules]
[Pages 51303-51329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 433, 437, and 457

[CMS-2440-P]
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: Proposed rule.

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SUMMARY: This proposed rule would establish the requirements for 
mandatory annual State reporting of the Core Set of Children's Health 
Care Quality Measures for Medicaid and 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. This proposed rule would also 
establish compliance requirements.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 21, 2022.

ADDRESSES: In commenting, please refer to file code CMS-2440-P. 
Comments, including mass comment submissions, must be submitted in one 
of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-2440-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-2440-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

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 
Dual Eligible (Medicaid and Medicare) Beneficiaries

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

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. Over the ensuing years, coverage under Medicaid has 
been extended to additional low-income populations. In addition, 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. Today, Medicaid and CHIP 
provide health coverage to approximately 88 million beneficiaries, 
approximately half of whom are children (40.4 million).\1\ Medicaid and 
CHIP provide

[[Page 51304]]

health care for some of the most vulnerable Americans, including 
individuals with very low incomes, pregnant women and children, and 
people with physical, cognitive, mental, and other disabilities who 
require long term services and supports (LTSS).
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    \1\ March 2022 Medicaid and CHIP Enrollment data: https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/march-2022-medicaid-chip-enrollment-trend-snapshot.pdf.
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    Despite the significant role that Medicaid and CHIP play in 
America's health care system, this regulation would require--for the 
first time--States, the District of Columbia (DC) and territories to 
mandatorily report on measures of the quality of health care provided 
to Medicaid and CHIP beneficiaries. Until the reauthorization of CHIP 
in 2009 by the Children's Health Insurance Program Reauthorization Act 
of 2009 (CHIPRA) (Pub. L. 111-3, enacted February 4, 2009), there were 
no Federal requirements regarding quality measurement to assess the 
care delivered to beneficiaries. Some quality measurement occurred at 
the State-level, but there was wide variation in the reliability and 
completeness of the data, as well as the types of measures reported. 
Different States focused on different health domains, and significant 
differences existed in the amount of State resources directed toward 
quality measurement, the data collection systems and capabilities for 
measuring quality in each State, and each State's priorities for 
quality improvement.
    Since the establishment of CHIP, participating States have been 
required to report annually on the operation of their CHIP State plan 
and progress in reducing the number of uninsured children under section 
2108 of the Act. Section 2108 of the Act also requires States to report 
data about enrollee access to networks of care, such as access to 
primary and specialty services and care coordination, using quality and 
satisfaction measures included in the Consumer Assessment of Healthcare 
Providers and Systems (CAHPS) survey.
    CHIPRA expanded upon these initial requirements. Not only were 
State reporting requirements for CHIP enhanced, but CHIPRA also 
required the Federal government to begin monitoring the quality of care 
and health outcomes for children enrolled in 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. Section 1139A of the Act directed the Secretary to 
publish for general comment an initial recommended core set of child 
health quality measures set 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. Following several 
rounds of review by the initial interested parties and comments from 
the public, CMS released the initial Child Core Set consisting of 24 
measures in 2009, with voluntary State-level reporting to begin in 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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    The importance of quality reporting was emphasized by Congress 
again in 2010 when section 2701 of the Affordable Care Act \3\ 
established a new section 1139B of the Act, extending the measurement 
of health care quality to Medicaid eligible adults. Like the Child Core 
set, the initial Core Set of Adult Health Care Quality Measures for 
Medicaid (Adult Core Set) was designed to reflect the health needs of 
adults enrolled in Medicaid, with measures capturing cancer screenings 
and management of chronic conditions. 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 this proposed rule). The initial Adult 
Core Set also included five behavioral health measures to capture use 
of preventive and treatment services for mental health and substance 
use disorders. CMS issued the initial Adult Core Set consisting of 26 
quality measures in 2012, and voluntary reporting of these measures 
began in FFY 2013.\4\
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    \3\ The Patient Protection and Affordable Care Act of 2010 (Pub. 
L. 111-148) was enacted on March 23, 2010. The Healthcare and 
Education Reconciliation Act of 2010 (Pub. L. 111-152), which 
amended and revised several provisions of the Patient Protection and 
Affordable Care Act, was enacted on March 30, 2010. In this 
rulemaking, the two statutes are referred to collectively as the 
``Affordable Care Act'' or ``ACA.''
    \4\ Initial Adult Core Set: https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/cib-01-04-12.pdf.
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    Congress has continued to advance quality reporting in Medicaid and 
CHIP by extending the appropriations for Core Sets reporting on a 
regular basis. The Protecting Access to Medicare Act of 2014 (PAMA), 
(Pub. L. 113-93, enacted April 1, 2014), the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA), (Pub. L. 114-10, enacted April 16, 
2015) and the Helping Ensure Access for Little Ones, Toddlers, and 
Hopeful Youth by Keeping Insurance Delivery Stable Act of 2017 (HEALTHY 
KIDS Act) (Pub. L. 115-120, enacted January 22, 2018) all directed 
funding to the continued development, submission, and reporting of 
health care quality measures in Medicaid and CHIP for the Child Core 
Set.\5\
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    \5\ The HEALTHY KIDS Act was enacted as part of H.R. 195, the 
Fourth Continuing Appropriations for Fiscal Year 2018, Federal 
Register Printing Savings, HEALTHY Kids, Health-Related Taxes, and 
Budget Effects (Pub. L. 115-120).
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    This regulation would implement 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 (SUPPORT) for 
Patients and Communities Act (SUPPORT Act), (Pub. L. 115-271, enacted 
October 24, 2018).

B. Quality Measurement of the Medicaid Health Homes Benefits Under 
Sections 1945 and 1945A of the Act

    In addition to requiring reporting on the Child Core Set and 
specified measures on the Adult Core Set, this proposed rule would 
establish 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. Sections 1945 (added by section 2703 of the 
ACA and later amended by section 1006(a) of the SUPPORT Act) and 1945A 
(added by section 3 of the Medicaid Services Investment and 
Accountability Act of 2019) \6\ give States options for implementing 
two different Medicaid health home State plan benefits. The section 
1945 health home benefit is for Medicaid-eligible individuals with two 
or more chronic conditions, with at least one chronic condition and who 
are at risk for a second, or with at least one serious and persistent 
mental health condition. Chronic conditions are defined in section 
1945(h)(2) of the Act to include mental health conditions, substance 
use disorders, asthma, diabetes, heart disease, and being overweight 
(body

[[Page 51305]]

mass index over 25).\7\ 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.\8\ States were able to begin 
covering the section 1945 health home benefit on January 1, 2011. 
States will be able to begin covering the section 1945A health home 
benefit on October 1, 2022.
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    \6\ Public Law 116-16, enacted April 18, 2019.
    \7\ 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.
    \8\ On August 1, 2022, we issued State Medicaid Director (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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    Under both of these optional Medicaid benefits, a health home is a 
designated provider (including a provider that operates in coordination 
with a team of health care professionals) or a health team that is 
selected to provide health home services by a person who is eligible 
for the optional benefit. See sections 1945(h)(3) and section 
1945A(i)(3) of the Act. Sections 1945 and 1945A of the Act also define 
health home services similarly. Section 1945 health home services are 
defined at section 1945(h)(4) of the Act as comprehensive care 
management; care coordination and health promotion; comprehensive 
transitional care, including appropriate follow-up, from inpatient to 
other settings; patient and family support (including authorized 
representatives); referral to community and social support services, if 
relevant; and the use of health information technology to link 
services, as feasible and appropriate. Section 1945A(i)(4) of the Act 
defines health home services as comprehensive care management; care 
coordination, health promotion, and providing access to the full range 
of pediatric specialty and subspecialty medical services, including 
services from out-of-State providers, as medically necessary; 
comprehensive transitional care, including appropriate follow-up, from 
inpatient to other settings; patient and family support (including 
authorized representatives); referrals to community and social support 
services, if relevant; and use of health information technology to link 
services, as feasible and appropriate.
    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. Additionally, section 
1945(c)(4)(B) of the Act requires certain States with an approved 
substance use disorder (SUD)-focused section 1945 health home State 
plan amendment (SPA) to report to the Secretary on the following with 
respect to SUD-eligible individuals provided health home services under 
the SUD-focused health home SPA: (1) the quality of health care 
provided to these individuals, with a focus on outcomes relevant to the 
recovery of each such individual; (2) the access of these individuals 
to health care; and (3) the total expenditures of these individuals for 
health care. Section 1945(c)(4)(B) 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]. CMS has 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.\9\ 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, CMS has 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).\10\
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    \9\ 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.
    \10\ https://www.medicaid.gov/federal-policy-guidance/downloads/smd-13-001.pdf.
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    The new optional section 1945A health home benefit also requires 
providers of that benefit to report to States on quality measures as a 
condition of payment. As a condition of receiving payment for section 
1945A health home services, 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. CMS interprets 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.
    CMS published an initial core set of section 1945 health home 
quality measures (section 1945 Health Home Core Set) on January 15, 
2013, in SMD letter #13-001, regarding ``Health Home Core Quality 
Measures.'' In developing the initial section 1945 Health Home Core 
Set, we consulted with States considering implementing the section 1945 
health home benefit, conducted technical assistance calls, 
presentations, and webinars, and worked with Federal partners, 
including the Office of the Assistant Secretary for Planning and 
Evaluation and the Substance Abuse and Mental Health Services 
Administration (SAMHSA). SMD letter #13-001 provided a recommended list

[[Page 51306]]

of 8 core measures that were chosen because they reflected key priority 
areas such as behavioral health and prevention measures.\11\ CMS also 
explained in that SMD letter 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.
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    \11\ https://www.medicaid.gov/federal-policy-guidance/downloads/
SMD-13-001.pdf.
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    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, CMS has generally tried to align it with the 
Child and Adult Core Sets. In November 2019, CMS released a 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.\12\
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    \12\ https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf
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    One feature of the section 1945 Health Home Core Set that differs 
from the Child and Adult Core Sets is that States collect provider-
specific data on health home program beneficiaries from providers as a 
condition of payment (per section 1945(g) of the Act) and then 
aggregate that data at the health home program (that is, SPA) level for 
reporting to CMS rather than reporting State-level data as is done for 
the Child and Adult Core Sets. States with multiple home health 
programs submit a separate report for each program to CMS. Program 
level reporting is necessary as a result of flexibilities in section 
1945 of the Act, which allows States to provide health home services on 
a less than statewide basis, allowing coverage of section 1945 health 
home services to be targeted to specific geographic areas within the 
State.
    This proposed rule would establish the following requirements for 
States electing to implement the benefit under sections 1945 or 1945A 
of the Act. CMS proposes to require States that have implemented the 
section 1945 and/or 1945A health home benefit to 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 to require their health 
home providers to report to the State on those measures. CMS proposes 
that 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 SUD-focused section 1945 health 
homes). For States covering the section 1945 health home benefit, this 
requirement would be 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 would also be 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 the proposals do 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 would be further 
supported by the language in 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 would be 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 proposed rule addresses 
part of the reporting required under section 1945A(g)(2)(A) of the Act 
(specifically, the proposed rule would implement 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 proposed 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, Adult, and section 1945 Health Home 
Core Sets represented 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. For 
instance, through the Child Core Set, data are collected on the 
percentage of children who receive preventive dental services and 
through the Adult and section 1945 Health Home Core Sets, data are 
collected on the number of adult beneficiaries who have their blood 
pressure under control. The Core Sets also have the potential to assess 
changes in the quality of and access to health care provided by State 
Medicaid and CHIP programs over time, and to make comparisons across 
States and health home programs. For example, the Core Sets capture 
data on the numbers of child and adult beneficiaries who have been seen 
by a provider following a hospitalization for mental illness--follow-up 
care that is critical to improving health outcomes for individuals 
suffering from mental illness. The ability to assess the quality of and 
access to care furnished by State Medicaid and CHIP programs is 
critical given the large number of vulnerable Americans who receive 
coverage in Medicaid and CHIP and the significant Federal and State 
resources needed to fund these programs.
1. Development of Core Sets
    To ensure that the measures included in the Core Sets reflect the 
needs of Medicaid and CHIP beneficiaries and provide the types of 
information necessary for true quality improvement, sections 1139A and 
1139B of the Act establish a number of specific parameters for the 
development of these core sets. As described in section 1139A(b)(2) of 
the Act, the measures included in the Child Core Set measures must be, 
at a minimum: (1) evidence-based and risk-adjusted, (2) designed to 
identify and eliminate racial and ethnic disparities in child health 
and the provision of health care; (3) designed to 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; (4) periodically updated; and (5) responsive to the 
child health needs, services, and domains of health care quality 
described in sections 1139A(a)(6)(A) (i), (ii), and (iii) of the Act 
(that is, preventive health services, acute care, chronic health care 
services, clinical care, health care safety, and family user 
experience). Section 1139B(a) of the Act requires the Secretary to 
utilize similar parameters for establishing the Adult Core Set.

[[Page 51307]]

    To ensure the continued relevance of the Core Sets and allow the 
measures to grow and change as the health care system changes, sections 
1139A and 1139B of the Act require the Secretary to create a Pediatric 
Quality Measurement Program and a Medicaid Quality Measurement Program 
and establish an annual, consensus-based process for identifying gaps 
in existing measures and establishing priorities for the development 
and advancement of new measures to address these gaps. Section 
1139A(b)(3) of the Act requires the Secretary to consult a broad range 
of interested parties, including States; pediatricians; children's 
hospitals; other primary and specialized pediatric health care 
professionals and dental professionals; providers that furnish health 
care to children and families in urban and rural medically underserved 
communities or who are members of distinct population sub-groups at 
heightened risk for poor health outcomes; national organizations 
representing children, including children with disabilities and 
children with chronic conditions; national organizations representing 
consumers and purchasers of children's health care; national 
organizations and individuals with expertise in pediatric health 
quality measurement; and voluntary consensus standards setting 
organizations and other organizations involved in the advancement of 
evidence-based measures of health care. Section 1139A(b)(5) of the Act 
directs the Secretary, beginning no later than January 1, 2013, and 
annually thereafter to publish recommended changes to the core measures 
described in section 1139A(a) of the Act that shall reflect the 
testing, validation, and consensus process for the development of 
pediatric quality measures described in paragraphs (1) through (4) of 
section 1139A(b) of the Act. Section 1139B(b)(5)(B) of the Act requires 
that the Secretary engage in a comparable process to annually update 
the Adult Core Set.
    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. CMS established 
the initial section 1945 Health Home Core Set quality measures for 
Medicaid-eligible children and adults following consultation with 
Federal partners and States considering health homes, technical 
assistance calls, presentations, and webinars. CMS selected the 
recommended core set of health home measures because they reflect key 
priority areas such as behavioral health and preventive care; and 
because they aligned with the initial Adult Core Set, the Medicaid 
Electronic Health Record (EHR) incentive program ``Meaningful Use'' 
measures, and with the National Quality Strategy. CMS has updated the 
section 1945 Health Home Core Set annually since 2013, and in 2021 CMS 
established a Health Home Annual Review Workgroup to align this update 
process with how CMS updates the Child and Adult Core Sets (as further 
discussed below). The updates have generally reflected the same 
considerations and followed the same process as applied to the 
development of the initial set.
    We have worked diligently with States and other interested parties 
through the formation of a joint Child and Adult Core Set Annual Review 
Workgroup to implement the statutory requirements and to ensure that 
measures in the Core Sets are meaningful for States and interested 
parties, feasible for State-level reporting, and represent minimal 
additional burden.\13\ In 2021, we established a separate Health Home 
Annual Review Workgroup 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 Set Annual Review Workgroup and the Health Home Annual 
Review Workgroup (``Workgroups'') are convened annually to 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. 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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    Workgroup members are able to recommend measures for addition or 
removal from the core sets.14 15 The measures that are 
recommended for addition need to meet criteria that include whether the 
measure has detailed technical specifications that enable production at 
the State-level or health home program level (as appropriate), and are 
available free of charge for State Medicaid and CHIP programs; and 
whether the measure has been tested or is currently in use by a State 
Medicaid or CHIP program. Measures that meet the criteria are presented 
for consideration at Workgroup meetings. A recommendation for addition 
or removal of a measure requires an affirmative vote from at least two-
thirds of eligible Workgroup members. When making recommendations, the 
Workgroups are asked to balance a number of considerations including 
the technical feasibility of measures, the desirability of measures for 
Medicaid and CHIP interested parties, and the operational viability for 
States and to focus on measures that meet all of them. In considering 
whether a new measure would meet the needs of interested parties and 
provide meaningful feedback, the Workgroups may consider how a measure 
would contribute to estimating the overall national quality of health 
care in Medicaid and CHIP together with other Core Set measures, 
whether it would provide useful and actionable results to drive 
improvement in care delivery and health outcomes, and whether it would 
address a strategic performance measurement priority. Other 
considerations evaluated by the Workgroups include alignment with 
measures used by other CMS and HHS programs and whether the prevalence 
of the condition or outcome being measured will produce meaningful and 
reliable results across States or health home programs (for example, 
are there enough beneficiaries with a specific medical diagnosis to 
allow a State to report on measures related to that diagnosis without 
jeopardizing the privacy of individual beneficiaries).
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    \14\ Child and Adult Core Sets Annual Report: https://www.mathematica.org/features/maccoresetreview.
    \15\ Health Home Core Set Annual Review: https://www.mathematica.org/features/hhcoresetreview.
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    Following each Workgroup meeting, a draft report summarizing the 
Workgroup recommendations is published for public comment. The public 
comments are then incorporated into the final report for each 
Workgroup, which is submitted to CMS.\16\ CMS then reviews the final 
report and obtains additional input from other Federal programs and 
States regarding priority health topics, areas for future measure 
development, and measure alignment across programs wherever possible, 
before making a final decision on which recommendations to accept. CMS 
announces the annual updates through a CIB (a combined CIB for the 
Child and Adult Core Sets and a separate CIB for the section 1945 
Health Home Core Set), which is also available on Medicaid.gov.
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    \16\ The public comment period for the Annual Workgroup report 
is 30 days.
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2. Strengthening Voluntary Reporting by States
    State reporting on both the Child and Adult Core Sets under 
sections 1139A

[[Page 51308]]

and 1139B of the Act, respectively, and on the specific measures in the 
section 1945 Health Home Core Set, has been voluntary since the 
inception of these Core Set reporting programs. For almost a decade we 
have worked closely with every State to improve annual reporting of 
measures. The number of measures voluntarily reported to CMS has 
increased every year, with the majority of States now reporting on at 
least one measure from the Child and Adult Core Sets.
    To effectuate meaningful quality improvement both within and across 
States, it is essential for States not only to report on the Core Sets 
measures, but to report on them in a clear and consistent manner. 
Sections 1139A(a)(4) and 1139B(b)(3) of the Act require the Secretary 
to develop a standardized format and reporting procedures for reporting 
of the Child and Adult Core Sets. Section 1945(g) of the Act provides 
that section 1945 health home providers must report quality measures to 
the State in accordance with such requirements as the Secretary shall 
specify. Section 1945(c)(4)(B) of the Act provides that the Secretary 
shall specify all applicable measures for quality reporting required 
under that provision. Section 1945A(g)(2)(A) of the Act provides that 
States with an approved section 1945A SPA must report certain 
information to the Secretary, including quality measures reported to 
the State under section 1945A(g)(1)(B) of the Act by section 1945A 
health home providers, in such form and manner determined by the 
Secretary to be reasonable and minimally burdensome. In addition, 
section 1902(a)(6) of the Act requires State Medicaid agencies to make 
such reports, in such form and containing such information, as the 
Secretary may from time to time require.
    Each year, we publish updated reporting guidance for the Child, 
Adult, and section 1945 Health Home Core Sets, which includes a summary 
of updates, as well as updated reporting tools, technical 
specifications and resource manual, data quality checklist, and 
measurement period table. However, considering the voluntary nature of 
State reporting, we have accepted reporting that does not comply with 
the reporting guidance, and we note in our annual reporting where 
States have deviated from measure specifications. After the section 
1945A Health Home Core Set is developed, CMS also expects to provide 
annual updates and other information about this core set through annual 
reporting guidance.
    We publicly report individual measures when 25 or more States 
report on that Child or Adult Core Sets measure using our published 
reporting guidance and the data meets standards for data quality. The 
first year of State reporting was FFY 2010 for the Child Core Set and 
FFY 2013 for the Adult Core Set. In the first year of Child Core Set 
reporting (FFY 2010), we publicly reported five measures. In FFY 2014, 
the first year of public reporting for the Adult Core Set, we reported 
10 Adult Core Set measures and 19 Child Core Set measures. In the most 
recent reporting year (FFY 2020), 21 of the 24 Child Core Set measures 
and 28 of the 33 Adult Core Set measures met our threshold for public 
reporting of State-specific results.17 18
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    \17\ Child Core Set Reporting: https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html.
    \18\ Adult Core Set Reporting: https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-care-quality-measures/index.html.
---------------------------------------------------------------------------

    Despite these improvements, however, not all measures meet the 
public-reporting threshold of 25 States and, even those that do, remain 
unreported for many States. The average State is reporting 73 percent 
of Child Core Set and 67 percent of Adult Core Set measures, the median 
number of measures reported by States for FFY 2020 is 17.5 for the 
Child Core Set and 22 for the Adult Core Set. Several important 
measures remain completely unreported, such as Screening for Depression 
and Follow-Up Plan (on both the Child and Adult Core Sets). In 
addition, not all States adhere to the technical specifications for the 
measures developed by CMS, and most States do not report measures for 
all their beneficiaries. State variation in reporting has left some 
populations behind in quality improvement efforts and has made 
meaningful comparisons across States difficult.
    As of June 2022, 19 States and D.C. have 34 different approved 
health home programs (that is, SPAs) targeting different populations. 
We publicly report all section 1945 Health Home measures voluntarily 
submitted by States, if they are reported by at least 15 section 1945 
health home programs using our published reporting guidance and the 
data meets standards for data quality, following data suppression rules 
when applicable. Of the 37 health home programs on which CMS encouraged 
States to report the section 1945 Health Home Core Set measures for FFY 
2020 based on program effective date, States voluntarily reported at 
least one measure for 34 of those programs.\19\ For each reporting 
cycle since FFY 2017, both the number of health home programs that CMS 
encouraged States to report on and the number of health home programs 
for which States voluntarily reported at least one section 1945 Health 
Home Core Set measure have increased. In the most recent reporting data 
available, FFY 2020, the median number of measures reported by States 
were 9 (of 12) measures for the section 1945 Health Home Core Set. One 
example of information ascertained from voluntary Health Home Core Set 
reporting is that emergency department visits decreased significantly 
between FFY 2017 and FFY 2020 on the ``Ages 18 to 64'' rate, the ``Age 
65 and older'' rate, and the total rate among those States that 
reported these rates all three years, representing better performance 
because lower rates are better on this measure.
---------------------------------------------------------------------------

    \19\ Section 1945 health home programs that have been in effect 
and implemented for a minimum of 6 months are encouraged to report 
on the 1945 Health Home Core Set annually to CMS.
---------------------------------------------------------------------------

    This data collection and reporting process is a critical foundation 
to driving improvement in the quality of care for Medicaid and CHIP 
beneficiaries, and we have worked extensively with States to encourage 
the use of Core Sets measure results to improve the quality of care 
delivered to their beneficiaries. We provide ongoing technical 
assistance to States to improve measure reporting, measure performance, 
quality of care delivered to beneficiaries, and the use of measures to 
gauge the effectiveness of quality improvement efforts. One-on-one 
technical assistance is offered directly to States, and CMS regularly 
hosts webinars and learning collaboratives in specific quality areas, 
such as oral health care, maternal and infant health, behavioral 
health, primary care and prevention, and care of chronic conditions. 
Through learning collaboratives, State Medicaid and CHIP agencies and 
their State partners have the opportunity to expand their knowledge of 
evidence-based interventions; improve their ability to conduct quality 
improvement projects; and engage in State-to-State learning on topics 
identified by States and other interested parties as most critical to

[[Page 51309]]

serving their beneficiaries, including asthma, oral health, and 
maternal and infant health.20 21 22 23  Core Sets reporting 
is also used to develop CMS's Medicaid and CHIP Scorecard; to measure 
the quality of care authorized through State section 1115 demonstration 
projects and Center for Medicare and Medicaid Innovation models focused 
on Medicaid; and in Medicaid managed care quality work to monitor 
plans' performance and drive improvement.24 25
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    \20\ Quality Improvement Initiatives: https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/index.html.
    \21\ Asthma Learning Collaborative: https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/improving-asthma-control-learning-collaborative/index.html.
    \22\ Oral Health Learning Collaborative: https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/advancing-prevention-and-reducing-childhood-caries-medicaid-and-chip-learning-collaborative/index.html.
    \23\ Maternal and Infant Health Quality Initiative: https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/maternal-infant-health-care-quality/index.html.
    \24\ Scorecard: https://www.medicaid.gov/state-overviews/scorecard/state-health-system-performance/index.html.
    \25\ Medicaid Managed Care Quality: https://www.medicaid.gov/medicaid/quality-of-care/medicaid-managed-care-quality/index.html.
---------------------------------------------------------------------------

D. Shifting From Voluntary to Mandatory Reporting

    In 2018, two bills were signed into law 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 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 fiscal year 2024. Specifically, section 1139A(a)(4)(B) of the 
Act states that beginning with the annual State report on fiscal year 
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, the SUPPORT Act, added a new subparagraph (B) to section 
1139B(b)(3) of the Act, 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 fiscal year 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 in this proposed rule, section 1945 of the 
Act, as initially enacted in 2010, required section 1945 health home 
providers to report information to States about implementation of the 
section 1945 health home benefit, but did not require States to submit 
reports to CMS about implementation of the section 1945 health home 
benefit. In 2018, the SUPPORT Act made State reporting of certain 
information about certain SUD-focused section 1945 health homes 
mandatory. Section 1945A of the Act also requires certain State 
reporting for that health home benefit. As discussed previously in this 
proposed rule, we are now proposing to require States that have opted 
to implement the section 1945 or section 1945A health home benefit to 
report to the Secretary on any measures identified by the Secretary 
through guidance as mandatory in either a section 1945 Health Home Core 
Set or a new section 1945A Health Home Core Set, or both (depending on 
which health home benefit(s) the State has elected to implement). The 
section 1945 Health Home Core Set would include measures that are 
required for State reporting under section 1945(c)(4)(B) of the Act for 
certain SUD-focused health homes. To enable States to provide these 
reports to CMS, we are also proposing to require States to require 
their health home providers to report on these measures to the State. 
These requirements would be authorized under section 1902(a)(6) of the 
Act, section 1945(c)(4)(B) and (g) of the Act, and section 1945A(g) of 
the Act, as discussed previously in this proposed rule. By establishing 
requirements for reporting on both Health Home Core Sets concurrently 
with the requirements for reporting on the Child and behavioral health 
measures in the Adult Core Sets, we can significantly improve alignment 
between the measures under all these quality reporting programs and 
ensure that States do not have to navigate multiple reporting processes 
and standards for these measures.

II. Provisions of the Proposed Rule

A. Basis, Scope, Purpose and Applicability

    This proposed rule would implement sections 1139A and 1139B of the 
Act, as amended, which set forth requirements for mandatory reporting 
on a core set of measures which assess the quality of care provided to 
child beneficiaries in Medicaid and CHIP and the quality of behavioral 
health care for Medicaid eligible adults. In Medicaid, the Adult and 
Child Core Set proposals are also authorized under 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. This proposed rule would help to fulfill 
the Secretary's obligation to establish and update a Child Core Set and 
Adult Core Set and to establish a standardized format and reporting 
procedures for States to use when reporting on these Core Sets and to 
publicly report this data. The proposals for the Health Home Core sets 
would implement sections 1902(a)(6), 1945(c)(4)(B), 1945(g), and 
1945A(g) of the Act, which require or (in the case of section 
1902(a)(6) of the Act) authorize the Secretary to require State 
reporting of health home quality measures and to set form and manner 
requirements for that reporting, and which also give the Secretary the 
authority to require States to require their health home providers to 
report on the same measures. The proposed rule would establish 
requirements for section 1945 health home quality measure reporting by 
providers, consistent with section 1945(g) of the Act, and would 
establish a process through which the Secretary would establish the 
form and manner of State reporting to CMS on section 1945A health home 
quality measures under section 1945A(g)(2)(A)(i) of the Act. Proposed 
Sec.  437.1(a) and (b) would set forth the basis and scope for these 
proposed requirements. The proposed rule would also set forth the 
process through which CMS would develop and update the Child Core Set, 
Adult Core Set, and the Health Home Core Sets (sections 1945 and 1945A) 
and the process through which CMS would establish requirements that 
State agencies would have to meet when reporting on the measures 
included in these Core Sets.
    The Child, Adult, and both Health Home Core Sets have tremendous

[[Page 51310]]

potential to assist States in monitoring and improving the quality of 
care provided to Medicaid and CHIP beneficiaries. As States see the 
actual impacts of the care provided to their beneficiaries and to 
compare the health outcomes of their beneficiaries to the outcomes 
achieved in other States, and for other Health Homes programs, their 
successes and the areas in which they need to improve will become 
clearer. As certain Medicaid and CHIP programs begin to stand out as 
models of care in specific areas, other States will be able to learn 
from them and adopt new models that are likely to improve the quality 
of care provided to their beneficiaries as well. With this in mind, we 
propose at Sec.  437.1(c)(1) to establish the purpose of the Child and 
Adult Core Sets. 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. At Sec.  437.1(c)(2), we 
propose to establish the purpose of the section 1945 and section 1945A 
Health Home Core Sets. The purpose of these 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 optional State plan 
benefits, monitor performance of these benefits at the program level, 
and improve the quality of health care. We believe these stated 
purposes would set a high bar for effective measurement of the quality 
of health care provided to millions of Americans every year and that 
resulting improvements in the health and well-being of Medicaid and 
CHIP beneficiaries would lead to better health for the entire nation.
    Applicability of the provisions in subpart A of part 437 differs 
based on the statutory basis for the Core Set reporting. The 
requirements for the Child and Adult Core Sets are described in Title 
XI of the Act, while the requirements for the Health Home Core Sets are 
described in Title XIX of the Act, and for purposes of section 1945A of 
the Act should include, to the extent applicable, child health quality 
measures and measures for centers of excellence for children with 
complex needs developed under Titles XIX and XXI and section 1139A of 
the Act. Section 1101(a)(1) of the Act defines a State, for purposes of 
Title XI, to include D.C., the Commonwealth of Puerto Rico, the Virgin 
Islands, and Guam. For purposes of Title XIX, American Samoa and the 
Mariana Islands are also included in the definition of State under 
section 1101(a) of the Act. Therefore, we propose at Sec.  437.1(d)(1) 
that the requirements for Child and Adult Core Sets reporting would 
apply to the 50 States, D.C., Puerto Rico, the Virgin Islands, and 
Guam; and throughout the proposed rule the term ``States'' is used to 
reflect these entities when CMS is 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 Sets measures. We propose 
at Sec.  437.1(d)(2) that 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. When 
CMS refers to a ``State'' when discussing the Health Home Core Sets in 
this proposed rule, this is the definition that CMS means. States that 
implement the section 1945 health home benefit would report on the 
section 1945 Health Home Core Set, States that implement the section 
1945A health home benefit would report on the section 1945A Health Home 
Core Set, and States that implement both benefits would report on both 
Health Home Core Sets. For all Child, Adult, and Health Home Core Sets 
measures, proposed Sec.  437.1(e) would provide that the requirements 
in subpart A apply no later than State reporting on the 2024 Core Sets 
by December 31, 2024.

B. Definitions

    Proposed Sec.  437.5 would establish definitions related to quality 
measurement and reporting. We propose to define the terms ``Child Core 
Set,'' ``Adult Core Set,'' ``Core Sets,'' ``Health Home Core Sets,'' 
``1945 Health Home Core Set,'' and ``1945A Health Home Core Set,'' to 
include the health care quality measures established and updated 
annually by the Secretary through subregulatory guidance, as described 
in proposed Sec.  437.10(a) and discussed in section I.C.1. of this 
proposed rule.
    We also propose to define ``behavioral health,'' and ``behavioral 
health measure'' at Sec.  437.5. Section 1139B(b)(5)(C) of the Act 
requires States 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.\26\ However, the statute does not define 
``behavioral health'' or ``behavioral health measures.'' We currently 
do not have a definition of behavioral health for use in the Adult Core 
Set for voluntary reporting and not all measures that are relevant to 
behavioral health are included in the behavioral health domain of the 
Adult Core Set, because such measures span multiple domains. For 
example, the ``Screening for Depression and Follow-up Plan'' measure is 
in the ``Primary Care Access and Preventative Care'' domain on the 
Adult Core Set because it is provided in the primary care setting. 
However, we believe this is clearly a behavioral health measure as 
well.
---------------------------------------------------------------------------

    \26\ Section 1139B of the Act: https://www.ssa.gov/OP_Home/ssact/title11/1139B.htm, Public Law 115-271, section 5001, amended 
paragraph (3) to include subparagraph (B). Effective October 24, 
2018.
---------------------------------------------------------------------------

    While the definitions differ slightly, other Department of Health & 
Human Services (HHS) agencies generally define behavioral health as 
including mental health and the identification of and treatment for 
SUD. In its criteria for certification of Certified Community 
Behavioral Health Clinics, SAMHSA defines behavioral health as ``the 
promotion of mental health, resilience and wellbeing; the treatment of 
mental and substance use disorders; and the support of those who 
experience and/or are in recovery from these conditions, along with 
their families and communities.'' \27\ The Public Health Service Act 
(Pub. L. 78-410) requires health centers under the Health Resources & 
Services Administration's (HRSA) Bureau of Primary Health Care to 
provide additional health services . . . including (A) behavioral and 
mental health and substance use disorder services.\28\ The Indian 
Health Care Improvement Act, the underlying authority for the Indian 
Health Service (IHS) provides, ``(A) In general the term ``behavioral 
health'' means the blending of substance (alcohol, drugs, inhalants, 
and tobacco) abuse and mental health disorders prevention and treatment 
for the purpose of providing comprehensive services.'' \29\
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    \27\ Definition of behavioral health for Certified Community 
Behavioral Health Clinics: https://www.samhsa.gov/sites/default/files/programs_campaigns/ccbhc-criteria.pdf.
    \28\ Health Center Program Statute: Section 330 of the Public 
Health Service Act (42 U.S.C. 254b).
    \29\ Indian Health Services statute: 25 U.S.C. 1603 (2): https://www.law.cornell.edu/uscode/text/25/1603#2_A, https://www.govinfo.gov/content/pkg/USCODE-2011-title25/pdf/USCODE-2011-title25-chap18.pdf.
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    The only CMS regulation that currently defines ``behavioral 
health'' can be found in the requirements for long term care facilities 
at Sec.  483.40, relating to the conditions of participation for 
skilled nursing facilities participating in Medicare and nursing 
facilities participating in

[[Page 51311]]

Medicaid. This regulation defines ``behavioral health'' as encompassing 
a resident's whole emotional and mental well-being, which includes, but 
is not limited to, the prevention and treatment of mental and substance 
use disorders. CMS resources for behavioral health of American Indians 
and Alaska Natives similarly explain that, ``Behavioral health includes 
the emotions and behaviors that affect your overall well-being. 
Behavioral health is sometimes called mental health and often includes 
substance use.'' \30\
---------------------------------------------------------------------------

    \30\ https://www.cms.gov/outreach-education/american-indianalaska-native/aian-behavioral-health.
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    While few programs appear to have formal definitions codified in 
statute, regulations or otherwise, there appears to be a general 
consensus that behavioral health services include services to address 
mental health conditions as well as SUDs. Some extend further to 
embrace psychological or emotional well-being. As such, at Sec.  437.5, 
we propose definitions of ``behavioral health'' and ``behavioral health 
measure'' for purposes of quality reporting by Medicaid and CHIP 
agencies that are derived from the definition at Sec.  483.40. We 
propose to define ``behavioral health'' as a beneficiary's whole 
emotional and mental well-being, which includes, but is not limited to, 
the prevention and treatment of mental disorders and substance use 
disorders. A ``behavioral health measure'' would be defined as 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).

C. The Child, Adult, and Health Home Core Sets

    As discussed in section I.A. of this proposed rule, the Secretary 
published the initial Child and Adult Core Sets in 2009 and 2012 
respectively. These initial core sets were developed with input from 
States and interested parties and comments from the public. The first 
updates to the Core Sets were published in 2013 (Child Core Set) and 
2014 (Adult Core Set). After receiving input from States and other 
interested parties, CMS has updated the Core Sets annually through a 
CIB.
    The section 1945 Health Home Core Set was initially introduced in 
2013, in SMD letter #13-001. Prior to the 2021 implementation of the 
Health Home Annual Review Workgroup process, CMS updated the 1945 
Health Home Core Set annually through a web posting, based on agency 
wide efforts to align quality measures across CMS programs.\31\ 
Currently, updates to the 1945 Health Home Core Set are conducted 
through an Annual Review Workgroup process that aligns with how similar 
workgroups are used to develop updates to the Child and Adult Core Set. 
Annual updates to the 1945 Health Home Core Set are currently developed 
through the Health Home Annual Review Workgroup review process and CMS 
releases the updates through a CIB. CMS anticipates developing and 
updating the section 1945A Health Home Core Set through this same 
workgroup process.
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    \31\ See, for example, Meaningful Measures: https://www.cms.gov/medicare/meaningful-measures-framework/meaningful-measures-20-moving-measure-reduction-modernization. https://www.cms.gov/medicare/meaningful-measures-framework/meaningful-measures-20-moving-measure-reduction-modernization.
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    In revising sections 1139A and 1139B of the Act to require State 
reporting on the Child Core Set and behavioral health measures on the 
Adult Core Set, neither CHIPRA nor the SUPPORT Act altered the 
statutory requirements regarding the annual updates to the Core Sets 
described in section I.C. of this proposed rule. As such, we propose at 
Sec.  437.10(a)(1) that we continue the existing annual process of 
identifying and updating the child health quality measures and adult 
health quality measures to be included in the Child and Adult Core 
Sets. We also propose to apply this annual process when identifying and 
updating the health home quality measures to be included in both Health 
Home Core Sets.
    At Sec.  437.10(a)(2), we propose that the Secretary consult 
annually with States and other interested parties identified in 
paragraph Sec.  437.10(e) to establish priorities for the development 
and advancement of the Child, Adult, and both Health Home Core Sets; to 
identify any gaps in the measures included in each Core Set; to 
identify measures which should be removed because they no longer 
strengthen the Core Sets; and to 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, are feasible for State-level and/or health-home program level 
reporting as appropriate, and represent minimal additional burden to 
States.
1. Annual Reporting Guidance
    As discussed in section I.C.2. of this proposed rule, sections 
1139A(a)(4) and 1139B(b)(3) of the Act require States to use the 
standardized format and procedures established by the Secretary when 
reporting on the Child and Adult Core Sets. In addition, section 
1945(g) of the Act provides that reporting by section 1945 health home 
providers to the State on quality measures must be in accordance with 
such requirements as the Secretary shall specify. Section 1945(c)(4)(B) 
of the Act provides that the Secretary shall specify all applicable 
quality measures that certain States with SUD-focused section 1945 
health homes must report under that provision. Section 1945A(g)(2)(A) 
of the Act provides that States with an approved section 1945A SPA must 
report certain information to the Secretary, including quality measures 
reported to the State by section 1945A health home providers, in such 
form and manner determined by the Secretary to be reasonable and 
minimally burdensome. Section 1902(a)(6) of the Act 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. At proposed Sec.  437.10(a)(3), we propose that the Secretary 
would develop and annually update reporting guidance needed by States 
to report on all Core Sets on which States would be required to report 
under this proposed rule.
    Providing States with clear and detailed guidance for reporting on 
measures in the Core Sets is essential to facilitating consistent 
reporting across States. Only with consistent, accurate reporting from 
States can we conduct meaningful analysis of quality measures, make 
comparisons across States, and support more effective quality 
improvement. Proposed Sec.  437.10(b) describes the components of the 
annual reporting guidance to be issued by CMS.
    As described at Sec.  437.10(b)(1), the first part of the reporting 
guidance would be the identification of quality measures in the Child 
Core Set, Adult Core Set, and the two Health Home Core Sets.\32\ As 
described in proposed Sec.  437.10(b)(1)(i) through (v), this would 
include: measures newly added to the Core Sets and measures removed 
from the prior year's Core Sets; measures included in the Adult Core 
Set that are identified as behavioral health measures; the specific 
Core Sets measures for which reporting is mandatory for the Child, 
Adult, and both Health Home Core Sets; the measures for which the 
Secretary would

[[Page 51312]]

complete reporting on behalf of States; and the measures for which 
States may elect to have the Secretary report on their behalf (see 
additional discussion in section II.D. of this proposed rule); as well 
as the measures (if any) for which the Secretary would provide States 
with additional time to report, along with the amount of additional 
time that would be provided.
---------------------------------------------------------------------------

    \32\ Core Set Measure lists are available at https://www.medicaid.gov/medicaid/quality-of-care/index.html.
---------------------------------------------------------------------------

    The second part of the reporting guidance, described at proposed 
Sec.  437.10(b)(2) through (b)(7), would specify the form and manner 
requirements for reporting. This includes information on how to collect 
and calculate the data on the Core Sets (Sec.  437.10(b)(2)) and the 
standardized format and procedures for reporting Core Sets measure data 
(Sec.  437.10(b)(3) and (4)).
    As described at proposed Sec.  437.10(b)(5) and (6), the reporting 
guidance would also identify the populations for which States must 
report on each measure and the attribution rules for reporting on 
beneficiaries who are included in more than one population during the 
reporting period. Proposed Sec.  437.10(b)(5) specifically notes three 
types of populations about which the Secretary would provide guidance: 
(1) beneficiaries receiving services through specified delivery systems 
(such as managed care or fee-for-service (FFS)), (2) beneficiaries 
receiving care through specified health care settings and/or provider 
types, and (3) beneficiaries who are dually eligible for Medicare and 
Medicaid. See additional discussion of this proposal in section II.D.3. 
of this proposed rule. We anticipate that, for State reporting on the 
Adult and Child Core Sets, the guidance on attribution rules described 
at proposed Sec.  437.10(b)(6), would call for inclusion in quality 
reporting 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 the guidance, we anticipate that we would 
set attribution rules to address transitions between Medicaid and CHIP 
or between different Medicaid eligibility groups, delivery systems, 
managed care plan assignment, etc. within a reporting year, for 
example, based on the length of time the child or adult was enrolled in 
each. For State reporting on the section 1945 and section 1945A Health 
Home Core Sets, we anticipate that the guidance on attribution rules 
described at proposed Sec.  437.10(b)(6) would call for inclusion in 
quality reporting based both on a beneficiary's continuous enrollment 
in Medicaid and their enrollment in an approved health home program. 
States would be expected to report on the applicable Health Home Core 
Set(s) when the applicable approved health home program has been in 
effect and implemented for 6 or more months of the measurement period 
(see discussion of proposed Sec.  437.15 below). If a State has 
recently changed or expanded an existing health home program through a 
SPA, we anticipate that it would be expected to include data related to 
the changed or expanded program with data from the original (that is, 
unchanged or unexpanded) health home program when the SPA has been in 
effect and implemented for 6 or more months of the measurement period.
    As described at proposed at Sec.  437.10(b)(7), the reporting 
guidance would also provide information on the stratification of 
certain measures by factors such as race, ethnicity, sex, age, rural/
urban status, disability, language, or such other factors as may be 
specified by the Secretary. Core Sets data stratification would be 
consistent with the statutory requirements outlined in section 
1139A(b)(2) of the Act and the goals of the Executive Order on 
Advancing Racial Equity and Support for Underserved Communities Through 
the Federal Government.\33\ At proposed Sec.  437.10(d), we propose 
that in specifying the measures for which data must be stratified and 
the factors by which such data must be stratified, the Secretary shall 
take into account 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 in the measures, and such other factors as the Secretary 
determines appropriate.
    Proposed Sec.  437.10(c) would provide the Secretary with 
discretion to provide a phase-in period for mandatory reporting of 
certain measures and certain populations for all the Core Sets. This 
phase-in is discussed in more detail in sections II.D.2. and II.D.3. of 
this proposed rule.
2. Advancing Health Equity Through Data Stratification
    Measuring and reporting health disparities is a cornerstone of 
CMS's approach to advancing health equity. Stratification of Child and 
Adult Core Sets data (sections 1139A and 1139B of the Act) and of data 
from the two Health Home Core Sets (sections 1945 and 1945A of the Act) 
is key to identifying health disparities among Medicaid and CHIP 
beneficiaries regarding those measures. Stratified data would allow us 
to monitor health outcomes for disparities between groups of patients 
who may have different determinants of 
health.34 35 36 37 These determinants of health 
include access to timely, high quality health care in addition to other 
social determinants of health such as a home environment that promotes 
health, and access to transportation and nutritious 
foods.38 39 40 Without this stratified data, disparities in 
health outcomes may be hidden, limiting opportunities for interventions 
to improve health outcomes and reduce health 
inequity.41 42 43
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    \34\ Racism and Health. Centers for Disease Control. https://www.cdc.gov/healthequity/racism-disparities/index.html.
    \35\ Improving Data Collection across the Health Care System. 
Content last reviewed May 2018. Agency for Healthcare Research and 
Quality, Rockville, MD. https://www.ahrq.gov/research/findings/final-reports/iomracereport/reldata5.html.
    \36\ Berg S. Improve health equity by collecting patient 
demographic data. American Medical Association. 2018. https://www.ama-assn.org/delivering-care/population-care/improve-health-equity-collecting-patient-demographic-data.
    \37\ Dorsey R., Graham G., Glied S., Meyers D., Clancy C., Koh 
H. Implementing Health Reform: Improved Data Collection and the 
Monitoring of Health Disparities. Annual Review of Public Health 
2014 35:1, 123-138. https://www.annualreviews.org/doi/full/10.1146/annurevpublhealth-032013-182423.
    \38\ Social Determinants of Health. Healthy People 2030. https://health.gov/healthypeople/objectives-and-data/social-determinants-health.
    \39\ CMS, State Health Official Letter #21-001, Opportunities in 
Medicaid and CHIP to Address Social Determinants of Health, Jan 7 
2021. https://www.medicaid.gov/federal-policy-guidance/downloads/sho21001.pdf.
    \40\ Hood, C., Gennuso K., Swain G., Catlin B. (2016). County 
Health Rankings: Relationships Between Determinant Factors and 
Health Outcomes. Am J Prev Med. 50(2):129-135. doi:10.1016/
j.amepre.2015.08.02.
    \41\ Bhalla R., Yongue B.G., Currie B.P. Standardizing Race, 
Ethnicity, and Preferred Language Data Collection in Hospital 
Information Systems: Results and Implications for Healthcare 
Delivery and Policy. Journal for Healthcare Quality. 2012;34(2):44-
52. doi: https://doi.org/10.1111/j.1945-1474.2011.00180.x.
    \42\ Office of the Assistant Secretary for Planning and 
Evaluation, Building the Evidence Base for Social Determinants of 
Health Interventions, Sep 23 2021. https://aspe.hhs.gov/reports/building-evidence-base-social-determinants-health-interventions.
    \43\ CMS Office of Minority Health. (Updated August 2018). Guide 
to Reducing Disparities in Readmissions. Baltimore, MD: Centers for 
Medicare & Medicaid Services. https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.

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[[Page 51313]]

    This approach to data reporting and stratification is aligned with 
Executive Order 13985, which calls for advancing equity for underserved 
populations.\44\ Stratified data would enable CMS and States to 
identify the health outcomes of those underserved populations and 
potential differences in health outcomes between such populations in 
these measures. By providing data pertaining to health outcomes for 
specific underserved populations, this proposal also aligns with the 
CMS Strategic Priorities.45 46
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    \44\ 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/.
    \45\ CMS Framework for Health Equity 2022-2032: https://www.cms.gov/files/document/cms-framework-health-equity.pdf.
    \46\ CMS Strategic Plan 2022: https://www.cms.gov/cms-strategic-plan.
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    Therefore, we propose at Sec.  437.10(b)(7) that the annual 
reporting guidance would identify the measures in the Child Core Set, 
the measures among the behavioral health measures of Adult Core Set, 
and the measures in the Health Homes 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 that 
this set of measures would be informed by annual consultation with 
States and other interested parties in accordance with proposed Sec.  
437.10(a)(2) and (d). We considered giving States the flexibility to 
choose which measures they would stratify and by what factors; however, 
more consistent measurement of differences in health outcomes between 
different groups of beneficiaries is essential to identifying areas for 
intervention and evaluation those interventions.\47\ This consistency 
could not be achieved if each State made its own decisions about which 
data it would stratify and by what factors.48 49
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    \47\ Schlotthauer A.E., Badler A., Cook S.C., Perez D.J., Chin 
M.H. Evaluating Interventions to Reduce Health Care Disparities: An 
RWJF Program. Health Aff (Millwood). 2008;27(2):568-573.
    \48\ Centers for Medicare & Medicaid Services (CMS) Office of 
Minority Health (OMH). Stratified Reporting. 2022; https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
    \49\ National Quality Forum. A Roadmap for Promoting Health 
Equity and Eliminating Disparities. Sep 2017. https://www.qualityforum.org/Publications/2017/09/A_Roadmap_for_Promoting_Health_Equity_and_Eliminating_Disparities__The_Four_I_s_for_Health_Equity.aspx.
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    We believe that this proposed stratification of data in the Child 
Core Set, Adult Core Set, and Health Homes Core Sets measures would be 
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 CMS. 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, and 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 recognize that States may be constrained in their ability to 
stratify Core Sets measures and that data stratification would require 
additional State resources. There are several challenges to 
stratification of measure reporting. First, the validity of 
stratification is threatened when the demographic data are incomplete. 
Complete demographic information is often unavailable to CMS and States 
due to several factors, including the fact that Medicaid and CHIP 
applicants and beneficiaries are not required to provide race and 
ethnicity data. Second, when States with smaller populations and/or 
that are more homogeneous stratify data, it may be possible to identify 
individual data because there are fewer individuals in each demographic 
category, raising privacy concerns. Therefore, if the sample sizes are 
too small, the data would be suppressed, in accordance with the CMS 
Cell Size Suppression Policy and the data suppression policies for 
associated measure stewards, and therefore, not publicly reported to 
avoid a potential violation of privacy.\50\
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    \50\ CMS Cell Size Suppression Policy, Issued 2020: https://www.hhs.gov/guidance/document/cms-cell-suppression-policy.
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    CMS's ability to stratify measures for which it is able to report 
on behalf of States will be dependent on whether the original dataset 
or survey instrument (1) collects the demographic information or other 
variables needed and (2) has a large enough sample size. There may be 
opportunities to supplement missing information to allow additional 
stratification, for example, using techniques such as ``geocoding'' 
that can be used to impute values for the stratification variables to 
the reported data. The Transformed Medicaid Statistical Information 
System (T-MSIS), for example, currently has the capability to stratify 
some Core Sets measures by sex and urban/rural status, but not by race, 
ethnicity, or disability status. This is because applicants provide 
information on sex and urban/rural address, which is reported to T-MSIS 
by States, whereas applicants are not required to provide information 
on their race and ethnicity or disability status, and often do not do 
so. However, CMS is developing the capacity to impute race and 
ethnicity from claims based on the name and home address of the 
beneficiary, and anticipates being able to stratify by race and 
ethnicity, urban/rural status, and sex by the end of 2022. While 
complete demographic information for beneficiaries would always be 
preferable to using imputed model values, reliable techniques to impute 
values is a substitute to enable identification and analysis of health 
disparities.
    With these challenges in mind, we propose at Sec.  437.10(d) that 
stratification of State reporting of Core Set data would be implemented 
through a phased-in approach in which the Secretary would specify, 
through the annual reporting guidance, which measures and by which 
factors States must stratify reported measures consistent with Sec.  
437.10(b)(7). The Secretary would take into account whether 
stratification can be accomplished based on valid statistical methods 
and without risking

[[Page 51314]]

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. States would 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 Homes 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 
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 
proposed Sec.  437.10(b)(7) such as race and ethnicity, sex, age, 
rural/urban, disability and language.
    We have determined that this proposed phased-in approach to data 
stratification would be reasonable and minimally burdensome, and thus 
consistent with section 1945A(g)(2)(A) of the Act, because we are 
balancing the importance of being able to identify differences in 
health outcomes between populations under these measures with the 
potential operational challenges that States may face in implementing 
these proposed requirements.
    We considered other timelines for phasing in mandatory 
stratification of the Child Core Set, behavioral health measures on the 
Adult Core Set, and Health Homes Core Sets from as short as 1 year to 7 
years, or up to 10 years. We are seeking to balance the changes needed 
to implement this new requirement with the urgent need to collect 
stratified data related to health care disparities. We determined that 
a shorter phase-in period for stratified reporting of the measures 
identified by the Secretary within the Child Core Set, behavioral 
health measures on the Adult Core Set, and Health Homes Core Sets, such 
as between 1 and 4 years, would not likely be operationally feasible 
and practicable because of the potential systems and contracting 
changes that States may be required to make in order to collect this 
data, but allowing implementation to extend beyond 5 years would delay 
the reporting of stratified data for Core Set measures much longer than 
would be necessary and would delay the time in which information about 
health disparities across these measures would be available for 
analysis . In addition, CMS anticipates 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 seek comment on 
whether 5 years is sufficient for phasing in required stratification of 
the Child Core Set, behavioral health measures of Adult Core Set, and 
Health Homes Core Sets, and whether States, providers, and other 
interested parties would need more, or less, time.
    We would provide technical assistance to assist States in improving 
their ability to collect the information required to allow for valid 
stratification. In Medicaid, enhanced Federal Financial Participation 
(FFP) is available at 90 percent for the design, development, 
installation, or enhancement 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.\51\ Receipt of these enhanced Federal Medicaid matching 
funds is conditioned upon States meeting a series of standards and 
conditions.\52\ 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. 
To the extent these system costs 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 cost, States can claim at a State's CHIP enhanced FMAP 
(EMAP) available under section 2105(b) of the Act. CHIP administrative 
funding is limited to 10 percent of either a State's total computable 
allotments for a fiscal year or its total expenditures reported for a 
fiscal year, whichever is lower.\53\
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    \51\ See Section 1903(a)(3)(A)(i) and (B) of the Act, Sec.  
433.15(b)(3) and (4), and subpart C of part 433.
    \52\ 42 CFR 433.112(b)(1) through (22) and 42 CFR 433.116.
    \53\ See 42 CFR 457.618(e)(1).
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    In addition to the factors discussed above, we are considering 
whether the annual reporting guidance would require States to also 
stratify data based on delivery system for the Child Core Set and 
behavioral health measures on the Adult Core Set. If we did require 
this, States would be required to identify whether a beneficiary 
received services on a FFS basis versus or through a managed care 
organization, including stratifying by health plan. This reporting 
would allow States to compare the differences in care provided to 
beneficiaries through different delivery mechanisms, and identify more 
focused interventions and policies to improve care. Given this benefit, 
CMS would like to include delivery system among stratification factors 
if feasible. However, due to the smaller sample size that generally 
would be reported for section 1945 and section 1945A health home 
programs, we are not considering requiring stratification of data based 
on delivery system for the Health Home Core Sets, as doing so would 
likely result in data suppression.
    We seek comment on the feasibility and the potential burden of 
requiring stratification through the guidance that would be issued 
under proposed Sec.  437.10(b)(7) based on delivery system, health 
plan, and population subgroup for the Child and Adult Core Sets and by 
population subgroup for both the section 1945 and section 1945A Health 
Home Core Sets. In addition, we seek comment on the potential burden of 
stratified measure reporting by race, ethnicity, and other demographic 
factors, as well as on the technical assistance that would be needed to 
support stratified State reporting.

D. Annual Reporting on the Child, Adult, and Health Home Core Sets

    At proposed Sec.  437.15, we propose the key requirements and 
procedures for States in the reporting of both mandatory and voluntary 
measures. At Sec.  437.15(a)(1)(i), we propose to require States to 
report annually, by December 31st, on the measures in the Child Core 
Set and the behavioral health measures in the Adult Core Set that are 
identified by the Secretary pursuant to proposed Sec.  
437.10(b)(1)(iii). Proposed Sec.  437.15(a)(1)(ii) would require States 
to 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 State 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. Proposed Sec.  
437.15(a)(1)(iii) provides that reporting of all Adult and Health Home 
Core Sets measures not identified as mandatory by the Secretary 
pursuant to Sec.  437.10(b)(1)(iii) would be optional (but CMS 
anticipates that it would strongly encourage States to report on these 
measures). Other exceptions to these mandatory reporting requirements 
are proposed at

[[Page 51315]]

Sec.  437.15(a)(4) and discussed in sections II.D.2. and II.D.3. of 
this proposed rule.
    As described at proposed Sec.  437.15(a)(2), certain measures would 
be reported by CMS on behalf of States. We currently report measures 
such as Live Births Weighing Less Than 2,500 Grams and Low-Risk 
Cesarean Delivery on behalf of States. As noted above, and as specified 
at proposed Sec.  437.10(b)(1)(iv), our annual reporting guidance would 
identify the measures for which we would complete annual reporting on 
behalf of States and the measures for which States may elect to have 
CMS report on their behalf. While the measures which we report on 
States' behalf are subject to change, any such measures would not be 
subject to the general reporting requirement at Sec.  437.15(a)(1)(i) 
and (ii).
    In an effort to streamline measure reporting and assist States in 
reporting overall, we have been assessing whether there are alternate 
data sources that can be used to calculate specific measures. For 
example, CMS is currently using pilot testing to determine the 
applicability of generating measure specific reporting from State data 
reported to CMS T-MSIS. However, even if CMS determines that T-MSIS 
Analytic Files (TAF) could be used to generate measure specific 
reporting, there may be issues which could prevent the use of T-MSIS 
TAF or reasons why States may prefer to continue to report the 
measures. For example, measures with a long lookback period may require 
more years of TAF data than are available. In addition, CMS may be 
required to enter into licensing agreements with measure stewards for 
specific measures. We have also been working with Federal partners to 
assess whether other Federal data sources could be used to report 
measures for States, including CDC's Wide-ranging Online Data for 
Epidemiologic Research (WONDER) databases and CAHPS survey measures 
from Agency for Healthcare Research and Quality. We seek comment on the 
use of T-MSIS TAF or other alternate data sources for Core Sets 
reporting and on CMS reporting on States' behalf.
1. Adherence to Reporting Guidance
    As discussed in section II.C.1. of this proposed rule, the 
Secretary, in consultation with States, updates reporting guidance for 
all measures annually.\54\ This reporting guidance includes a 
standardized format and procedures for State reporting of Core Sets 
measures. Not all States consistently adhere to the specifications and 
reporting formats prescribed by the Secretary. Each year, we spend 
several months working with States to resolve data quality issues and 
confirm any deviations from the reporting guidance. If all States 
adhere to the CMS reporting guidance, data quality would improve, data 
analysis would be streamlined and more meaningful, and annual data 
products would be available for use more quickly. Therefore, we propose 
at Sec.  437.15(a)(3) that, except as described in Sec.  437.15(a)(4), 
all State Core Set measure reporting would need to be in accordance 
with the guidance developed by the Secretary pursuant to proposed Sec.  
437.10(b), including the guidance developed by the Secretary under 
Sec.  437.10(b)(3) and (4) about a standardized format for reporting 
measure data and procedures State agencies must follow in reporting 
measure data.
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    \54\ Child and Adult Core Set reporting guidance: https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/index.html.
    Health Home Core Set reporting guidance: https://www.medicaid.gov/resources-for-states/medicaid-state-technical-assistance/health-home-information-resource-center/health-home-quality-reporting/index.html.
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    We recognize that adherence to CMS-issued reporting guidance as 
described in proposed Sec.  437.15(a)(3) would be a substantial change 
from the way some States currently report measures, which is based on 
either their own programming specifications or that of their 
contractors. Therefore, States may need to reprogram their reporting 
systems to adhere to the reporting guidance. As such, we considered not 
requiring use of the reporting guidance at all. However, we believe 
that adherence to the reporting guidance is the best way to provide 
true comparisons across States on quality measure performance and to 
derive national performance rates of the care provided to Medicaid and 
CHIP beneficiaries. In addition, we are actively working to reduce 
State burden by streamlining reporting and developing alternate methods 
of reporting measures, including methods described above, by which CMS 
will obtain data and complete reporting on behalf of States. We seek 
comments on this approach, as well as strategies that CMS may implement 
to provide the best technical assistance to States as they transition 
to standardized reporting and what States have found helpful in the 
past, such as one-on-one sessions, written guidance, measure 
specification and coding assistance, site visits, webinars, learning 
collaboratives, and other opportunities to hear best practices and from 
other States, or any other ideas not listed here.
2. Phased-in Reporting for Certain Mandatory Measures
    As noted above, proposed Sec.  437.10(c) would allow the Secretary 
to establish a phase-in period for reporting of certain measures, 
depending on their complexity, and proposed Sec.  437.15(a)(4) provides 
exceptions to the mandatory reporting requirements at Sec.  
437.15(a)(1) for measures to be phased-in. The Core Sets include more 
than one type of quality measure, with differing data collection 
processes and requirements. We recognize that some types of data 
collection are more administratively burdensome than others.
    Some measures, often referred to as ``administrative measures,'' 
are typically calculated from information included in claims. These 
measures, which typically are the easiest for States to report, 
generally focus on health care utilization and cost. Measures which 
focus on health outcomes for beneficiaries, often referred to as 
``outcomes measures'' or ``hybrid measures,'' typically require 
clinical information from medical records as well as administrative 
data from claims. Clinical information may be obtained from chart 
reviews or information stored in electronic health records (EHRs). 
Other measures on the Core Sets are calculated from surveys such as 
CAHPS.
    While measures of health outcomes are often the most meaningful 
types of measures, they can also be the most challenging to report. 
States often struggle with collecting data for measures that depend on 
either non-claims sources, hybrid specifications, or EHRs. Chart 
reviews have been a common method of obtaining the clinical information 
needed for hybrid measures that is not available from claims, such as 
referral to treatment or blood pressure rates. However, chart reviews 
are expensive, and require a trained reviewer to manually review and 
obtain needed information on a set number of charts. Other methods of 
data collection, such as obtaining clinical information from EHRs, may 
require complex computerized patient matching processes that take time 
and resources to develop, as well as negotiation of appropriate data 
use agreements between State Medicaid and CHIP agencies and other State 
agencies or private entities (for instance, EHR vendors). We seek 
comments on how best to phase-in reporting of health outcome and survey 
measures for Medicaid and CHIP and the frequency of reporting these 
measures. In addition, to support States in meeting the

[[Page 51316]]

proposed mandatory reporting requirements, we seek comment on the 
technical assistance States might need from CMS to be able to report on 
health outcomes and survey measures. We also seek comments on promising 
practices and approaches for accurate electronic data capture of race 
and ethnicity and other demographics; programmatic requirements; and 
best practices and lessons learned from linking records from disparate 
data sources for measure calculation and reporting.
    New and modified measures pose additional challenges. When a new 
measure is added to the Core Sets, or the measure specification 
changes, States must adjust their collection processes, which may 
require corresponding contractual updates. As such, it may not always 
be possible for States to report measures to CMS in the first year 
after they are added to the Core Sets, even when they rely on claims 
data alone but especially when they require other types of data.
    Thus, while mandatory reporting would be required, as described at 
proposed Sec.  437.10(b)(1)(iii) and Sec.  437.15(a)(1), beginning with 
FFY 2024 reporting, we propose at Sec.  437.15(a)(4)(i) that reporting 
of measures identified by the Secretary for phase-in under Sec.  
437.10(c) would be optional for FFY 2024 and subsequent years as 
identified in the reporting guidance, but not required. Similarly, when 
a new measure is added to the Child Core Set, a new behavioral health 
measure is added to the Adult Core Set, or a new measure is added to 
either of the Health Home Core Sets, reporting of the new measure may 
not be required immediately. Per proposed Sec.  437.10(c), in 
determining which measures would be subject to a phase-in period and 
how long such phase-in period would be, the Secretary would take into 
account the level of complexity required for States to report the 
measure. As also proposed in Sec.  437.10(b)(1)(v) and (c), the 
Secretary would specify any such phase-in periods in the annual 
reporting guidance described in proposed Sec.  437.10(b). We believe 
that giving States more time to refine their data collection and 
reporting systems for ``difficult to report'' measures, would improve 
the accuracy of State reporting. Recognizing that the hard-to-report 
outcomes measures are often the most meaningful measures, we plan to 
provide intensive technical assistance to assist States in successfully 
reporting on such measures.
3. Phased-in Reporting for Certain Populations
    We propose at Sec.  437.10(b)(5) that the Secretary would identify, 
through annual reporting guidance, those populations for which States 
would be required to report measure data for a given year. Recognizing 
the challenges that States face in reporting measure data for certain 
populations, proposed Sec.  437.10(c) provides that the Secretary would 
also be authorized to provide, in the annual reporting guidance, that 
mandatory State reporting for certain populations could be phased in 
over a specified period of time, and that the Secretary's 
identification of such populations would take into account the level of 
complexity required for States to report the measure for different 
populations. Historically, due to the voluntary nature of reporting on 
measures in the Core Sets, States have not included all the populations 
identified in the measure specifications when reporting Core Sets 
measures to CMS. For example, some States currently report Medicaid 
beneficiaries but not CHIP beneficiaries. Other States include only 
beneficiaries enrolled in managed care but not FFS beneficiaries or 
omit reporting for beneficiaries enrolled in both Medicaid and 
Medicare.
    Under this proposal, the Secretary would specify each year, in the 
reporting guidance issued under Sec.  437.10(b), the populations on 
which States would be required to report the Core Set measures, and 
whether mandatory reporting for certain populations could be phased in 
over time. CMS anticipates that this annual guidance would take the 
following statutory language into consideration. The statutory language 
in section 1139A(a)(4)(B) of the Act requires mandatory reporting of 
measures on the Child Core Set for pediatric health care under Titles 
XIX and XXI of the Act. Section 1139B(b)(3)(B) of the Act provides for 
development of a core set of adult health quality measures for Medicaid 
eligible adults and requires that States report on all behavioral 
health measures included in the Adult Core Set starting in 2024. To 
improve the quality of care delivered to all Medicaid and CHIP 
beneficiaries, we interpret this language as requiring that reporting 
for the Child Core Set include all beneficiaries covered by Medicaid 
and CHIP and reporting for the behavioral health measures in the Adult 
Core Sets include all beneficiaries covered by Medicaid. This includes 
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.
    With respect to health home measure reporting, section 1945(g) of 
the Act provides that section 1945 health home providers must report to 
the State, in accordance with such requirements as the Secretary shall 
specify, on all applicable measures for determining the quality of 
section 1945 health home services. Section 1945(c)(4)(B) of the Act 
specifies that the reporting required under that provision should be 
with respect to SUD-eligible individuals provided health home services 
under the applicable SPA. Section 1945A(g)(1)(B) of the Act requires 
health home providers to report to the State information on all 
applicable measures for determining the quality of section 1945A health 
home services delivered by the provider. Section 1945A(g)(2)(A)(i) of 
the Act requires a State implementing the section 1945A health home 
benefit to report to the Secretary all quality information that the 
State received from its health home providers under section 
1945A(g)(1)(B) of the Act. In addition, section 1902(a)(6) of the Act, 
on which CMS also relies for these proposals, provides that State 
Medicaid agencies must make such reports, in such form and containing 
such information, as the Secretary may from time to time require. Taken 
together, these provisions would support guidance under Sec.  437.10(b) 
that requires State reporting for the Health Home Core Sets to include 
all beneficiaries enrolled in the applicable health home program. 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. We would 
anticipate that health home programs would have to report on 
beneficiaries who have received Medicaid-covered services in FQHCs, 
RHCs, and facilities operated by IHS, Tribes and Tribal Organizations, 
and Urban Indian Organizations only if a beneficiary who

[[Page 51317]]

is enrolled in the applicable health home program received Medicaid-
covered services in one of these settings during the measurement 
period.
    Currently, most States do not include all their Medicaid and CHIP 
population in their Core Set reporting; most States report only on a 
subset of their entire Medicaid and CHIP population when reporting on 
the Child and Adult Core Sets, and do not report on the entire 
population of health home program beneficiaries when reporting on the 
section 1945 Health Home Core Set. Populations for which many States do 
not currently report Core Sets measure data include: (1) beneficiaries 
who are dually-eligible for Medicare and Medicaid; (2) beneficiaries 
served by IHS, Tribes and Tribal Organizations, or Urban Indian 
Organizations; (3) beneficiaries served by FQHCs, and (4) beneficiaries 
receiving services on a FFS basis in a State where most beneficiaries 
are enrolled in a managed care plan.
    Some States do not include in their reporting FFS dually eligible 
beneficiaries because such reporting often requires additional work to 
obtain and analyze Medicare utilization data. In 2019, there were 12.3 
million individuals simultaneously enrolled in Medicare and Medicaid, 
also known as dually eligible beneficiaries.\55\ This includes 
beneficiaries who receive full Medicaid benefits and beneficiaries 
whose Medicaid coverage is limited to payment of Medicare premiums and/
or cost sharing. Forty-one percent of dually eligible beneficiaries 
have at least one mental health diagnosis, and 60 percent have multiple 
chronic physical and/or mental health conditions.56 57 Since 
Medicare is the primary payer for dually eligible beneficiaries for 
services covered by both Medicare and Medicaid, we believe State 
Medicaid data may be insufficient to perform analysis on certain Core 
Set measures for dually eligible beneficiaries. For example, Medicare 
utilization data, along with State Medicaid data, is necessary to 
report on 12 of the 13 behavioral health measures on the Adult Core Set 
for dually eligible beneficiaries. Therefore, based on the current 
measure specifications, we believe States need Medicare utilization 
data combined with State Medicaid data to fulfill reporting completely 
and accurately on Core Sets measures for dually eligible beneficiaries. 
Via the Medicare-Medicaid Data Sharing Program, CMS makes available 
certain Medicare data to States free of charge, which States can use to 
help fulfill reporting on Core Sets measures for this population.\58\ 
While we currently provide technical assistance, and will continue to 
do so, including written instruction, to assist States in requesting 
and analyzing Medicare data, we solicit comment on additional 
considerations and technical assistance that would help States more 
easily obtain and use the Medicare data to calculate the Core Sets 
measures for dually eligible beneficiaries.
---------------------------------------------------------------------------

    \55\ https://www.cms.gov/files/document/medicaremedicaiddualenrollmenteverenrolledtrendsdatabrief.pdf.
    \56\ Physical and Mental Health Condition Prevalence and 
Comorbidity among Fee-For-Service Medicare-Medicaid Enrollees. 
Centers for Medicare & Medicaid Services, September 2014. Available 
at https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/Dual_Condition_Prevalence_Comorbidity_2014.pdf.
    \57\ Medicare-Medicaid Enrollee Information, National 2012. 
Available at https://www.cms.gov/Medicare-Medicaid-Coordination/
Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-
Office/Downloads/
NationalProfile_2012.pdf#:~:text=Nationally%2C%20in%202012%2C%20among
%20Medicare-
%20Medicaid%20FFS%20enrollees%3A,%26%20Medicaid%20Services%20%7C%20Me
dicare-Medicaid%20Coordination%20O%EF%AC%83ce%204.
    \58\ For more information on the Medicare-Medicaid Data Sharing 
Program please see here https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/StateAccesstoMedicareData or contact the State 
Data Resource Center at https://www.statedataresourcecenter.com/home/contact-us.
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    Similarly, States might not include in their reporting measure data 
for beneficiaries receiving health care services at FQHCs, RHCs, or 
from IHS, Tribes and Tribal Organizations, or Urban Indian 
Organizations, because State Medicaid agencies may not receive claims 
data needed for measure reporting from those facilities. In 2018, more 
than 1.8 million American Indians and Alaska Natives were enrolled in 
coverage through Medicaid and CHIP.\59\ Currently, there is no national 
database for health care services provided at Tribal facilities. Each 
Tribal entity is responsible for reporting its own claims and the level 
of detail provided, such as type of clinical service provided or 
diagnosis, varies by facility and by State; each State establishes its 
own guidance for health care facilities operated by IHS, Tribes and 
Tribal Organizations, and Urban Indian Organizations. While we are 
currently working with IHS to determine best practices, we solicit 
comment on additional considerations and technical assistance support 
that would help States more easily obtain and use the health care 
facility data from IHS, Tribes and Tribal Organizations, and Urban 
Indian Organizations that would be needed to calculate the Core Sets 
measures.
---------------------------------------------------------------------------

    \59\ https://www.medicaid.gov/medicaid/indian-health-medicaid/index.html.
---------------------------------------------------------------------------

    FQHCs, defined for Medicaid purposes at section 1905(l)(2)(B) of 
the Act, are (1) community-based health care providers that either 
receive grant awards from the HRSA Health Center Program under section 
330 of the Public Health Service Act to provide primary care services 
in underserved areas or are designated by HRSA as Health Center Program 
look-alikes; or (2) outpatient health programs or facilities operated 
by a tribe or tribal organization under the Indian Self-Determination 
Act (Pub. L. 93-638, enacted January 4, 1975) or by an Urban Indian 
Organization receiving funds under Title V of the Indian Health Care 
Improvement Act for the provision of primary health services. FQHC 
clients may include but are not limited to Medicaid and CHIP 
beneficiaries. HRSA's Health Center Program includes approximately 
1,400 health centers with more than 10,000 delivery sites in the U.S., 
DC, Puerto Rico, the Virgin Islands, American Samoa, Guam, the 
Federated States of Micronesia, Marshall Islands, and the Northern 
Mariana Islands.\60\ While Health Center Program awardees and look-a-
likes report to a Uniform Data System (UDS), which contains clinical 
quality measures that align with CMS's electronic-specified Clinical 
Quality Measures (e-CQMs), not all Core Set measures are currently able 
to be calculated using data from the UDS. Additionally, States vary in 
their access to these data and therefore inclusion in Core Sets 
reporting. We are working with HRSA to determine best practices and 
will then provide technical assistance to States and territories on how 
to include these data in Core Set reporting. We solicit comment on 
additional considerations and technical assistance support that would 
help States and territories more easily obtain and use the FQHC and RHC 
data needed to calculate the Core Sets measures.
---------------------------------------------------------------------------

    \60\ HRSA UDS https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/reporting/2019-uds-manual.pdf.
---------------------------------------------------------------------------

    FFS Medicaid beneficiaries in managed care States often are not 
included in Core Sets reporting because States rely on data collected 
by their managed care organizations and States have not invested in the 
infrastructure needed to report data from their smaller FFS 
populations. Omission of these populations from measure reporting 
limits the ability to evaluate the quality of care provided to the 
entirety of a State's Medicaid and CHIP population (or health home 
program), to determine

[[Page 51318]]

potential health care disparities across delivery systems and 
subpopulations, and to compare the quality of care across States.
    As discussed, reporting guidance published by the Secretary under 
proposed Sec.  437.10(b) would, per Sec.  437.10(b)(5), identify the 
populations for which States must report quality measures, and under 
proposed Sec.  437.10(c) may provide that mandatory State reporting for 
certain measures and reporting for certain populations of beneficiaries 
will be phased in over a specified period of time. Per proposed Sec.  
437.15(a)(3), which would require States to adhere to the reporting 
guidance issued by the Secretary under Sec.  437.10(b) when reporting 
on Core Sets Measures (except as described in Sec.  437.15(a)(4)), 
reporting on the Child Core Set and the behavioral health measures in 
the Adult Core Set, as required at proposed Sec.  437.15(a)(1)(i), 
would have to include all beneficiary populations identified by the 
Secretary under proposed Sec.  437.10(b)(5). Reporting on both Health 
Home Core Sets, as required at proposed Sec.  437.15(a)(1)(ii), would 
have to include all beneficiary populations identified by the Secretary 
under proposed Sec.  437.10(b)(5). Proposed Sec.  437.15(a)(4)(ii) 
would exempt States from having to report on populations for whom 
reporting is not yet phased in. States would initially be encouraged, 
but not required, to report on populations for whom mandatory reporting 
is not yet phased in.
    We are developing strategies to improve State access to Medicaid 
data in order to improve reporting capabilities. For example, we are 
developing strategies to improve reporting for beneficiaries served by 
IHS, Tribes and Tribal Organizations and Urban Indian Organizations. 
Some States have been able to leverage their Health Information 
Exchanges to accomplish more complete reporting of entire Medicaid and 
CHIP populations, and we are planning to work with those States to 
identify and share best practices with other States and facilitate 
peer-to-peer learning. Finally, we are currently piloting technical 
assistance work with States with the idea of providing written 
resources and guidance.
    Ultimately, as we continue to provide technical assistance and 
States continue to build capacity, we expect to require States to 
report on the populations discussed above for each Core Set through the 
annual reporting guidance. This will help achieve data consistency 
across States and provide useful and actionable quality measurement 
data to identify disparities and support efforts to improve the quality 
of healthcare provided by State Medicaid and CHIP agencies for all 
beneficiaries.
    In developing these proposals, we considered proposing to require 
States to report the measures on the Child Core Set for all populations 
served by Medicaid and CHIP, and the behavioral health measures on the 
Adult Core Set for all Medicaid adult populations beginning in FFY 
2024, with no provision for the Secretary to allow a phased-in 
approach. We also considered proposing to require States to report the 
measures for both Health Home Core Sets for all beneficiaries enrolled 
in approved health home programs beginning in FFY 2024, with no phased-
in approach. However, we are concerned that it may not be feasible for 
States to begin reporting on all populations by the FFY 2024 reporting 
year. A flexible approach to identifying mandatory populations in 
annual guidance that permits phasing in mandatory reporting for certain 
populations, as proposed in Sec.  437.10(b)(5) and (c) and Sec.  
437.15(a), would give States time to develop the infrastructure and 
resources to allow them to report on all Medicaid, CHIP, and health 
home program beneficiary populations. We seek comments on how best to 
provide technical assistance to assist States so they can report on all 
populations specified by the Secretary each year for the Medicaid, 
CHIP, and Health Home Core Sets, and ultimately, so that they can 
report on all Medicaid, CHIP, and health home program beneficiary 
populations, as well as on how long States might need to be able to 
report on all Medicaid, CHIP, and health home program beneficiary 
populations.
4. Separate Reporting of the Child Core Set for Medicaid and CHIP 
Beneficiaries
    Currently, some States report the Child Core Set for their Medicaid 
population, but not for their CHIP population, while other States 
report these populations together. As discussed previously, it is 
important that Child Core Set measures are reported for all populations 
covered in both Medicaid and CHIP. We believe it is also important to 
monitor and analyze quality performance in separate CHIPs independently 
from Medicaid programs to allow for comparison of performance between 
the programs. Therefore, we propose at Sec.  437.15(b) 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).
    Most States currently report measures separately for the two 
programs, yet their methods of collecting and reporting the measures 
may differ. Under this proposed rule, State Medicaid programs and CHIPs 
would be required to use the same reporting guidance, as described at 
proposed Sec.  437.15(a)(3) and proposed Sec.  457.770 respectively, 
including technical specifications (that is, hybrid, administrative, 
etc.), for reporting quality measures for both Medicaid beneficiaries 
and separate CHIP beneficiaries. The use of consistent methodologies 
would allow the Medicaid and CHIP rates to be validly combined by CMS 
for an overall State rate.
    We recognize that it is not uncommon for children to move between 
Medicaid and CHIP as their family income fluctuates. Because many 
measure specifications require 12 months of continuous eligibility to 
be included in the data reported, there is potential for children who 
move between the programs during a 12 -month period to not be captured 
when the programs report separately. Under this proposed rule, States 
would capture children who transfer between the two programs through 
common reporting guidance. The reporting guidance would include 
attribution rules, as described at proposed Sec.  437.10(b)(6), for 
example, based on the length of time the child was enrolled in each 
program, the attribution rules would clarify in which program (Medicaid 
or CHIP) a State would count a child who transitioned between programs 
within a reporting year.
    Reporting in this manner would (1) maximize the number of children 
captured in the data; (2) support production of a median overall 
combined State performance rate to compare the quality of care across 
States; (3) enable comparisons of performance between Medicaid and CHIP 
programs; and (4) identify health disparities in Medicaid and CHIP 
populations both within a State and nationally.
    We considered requiring States with separate CHIPs to report on the 
Child Core Set measures for all Medicaid and separate CHIP-covered 
children together to ensure that children who transition between 
programs would not be lost and, if so, the attribution rules to 
determine in which program a child who transitioned between Medicaid 
and CHIP during the reporting period should be included. We seek 
comment on how best to provide technical assistance to

[[Page 51319]]

assist States in resolving data issues when a State with separate CHIP 
collects Child Core Set measures using different reporting guidance or 
data sources from those used for the collection of Child Core Set 
measures in their Medicaid population. We also seek comment on whether 
States with separate CHIPs should combine Medicaid and separate CHIP 
Child Core Set reporting in order to ensure that children who 
transition between programs are not lost and, if so, the attribution 
rules to determine in which program a child who transitioned between 
Medicaid and CHIP during the reporting period should be included.

E. Application to CHIP for the Child and Adult Core Sets

    Section 1139A(a)(1) of the Act requires the Secretary to develop a 
core set of measures for reporting on the quality of health care 
provided to children by State programs administered under titles XIX 
and XXI. Beginning with the FFY 2024 annual report, section 
1139A(a)(4)(B) of the Act requires State reporting on the quality of 
pediatric health care provided under both title XIX and title XXI 
utilizing the standardized format and procedures established by the 
Secretary. Section 1139B(a) of the Act requires the Secretary to 
develop a core set of measures for reporting on the quality of health 
care provided to adults under title XIX in the same manner as that used 
to develop the Child Core Set. However, 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 such, a separate CHIP is encouraged, but 
not required, to report on the measures in the Adult Core Set.
    At Sec.  457.700, we propose to add sections 1139A and 1139B of the 
Act as additional bases for quality reporting in CHIP. Under these 
statutory provisions, we propose at Sec.  457.770(a) to require that 
separate CHIPs report on all measures in the Child Core Set in 
accordance with the requirements in part 437. Because each measure in 
the Child Core Set (as well as the Adult Core Set) has its own age 
requirements, which are established by the measure steward, the State 
would be required to report on the quality of care provided to all CHIP 
beneficiaries who fall within the age range for each measure in the 
Child Core Set, not just those beneficiaries covered as a targeted low-
income child. For example, the 2022 Child Core Set includes a measure 
on asthma medication, which is applicable to individuals between the 
ages of 5 and 18. In a State that covers both targeted low-income 
children and targeted low-income pregnant individuals, the State would 
be required to report on the asthma medication measure for all 
beneficiaries aged 5 through 18 who are eligible as either a targeted 
low-income child or a targeted low-income pregnant individual.
    At proposed Sec.  457.770(b), we strongly encourage States to also 
follow the requirements of part 437 for any voluntary reporting on the 
measures in the Adult Core Set. As such, if a State elected to report, 
for example, on the 2022 Adult Core Set Measure of flu vaccinations for 
individuals ages 18 to 64, the State would report on this measure with 
respect to targeted low-income children who are age 18 and targeted 
low-income pregnant individuals, if covered by the State, who are 
within the age range for this measure.
    States also have the option to extend special CHIP child health 
assistance for the duration of pregnancy (also referred to as the 
``unborn option'') in compliance with applicable eligibility criteria 
for coverage under the CHIP State plan, thereby providing coverage to 
pregnant individuals who themselves are not eligible for Medicaid or 
CHIP. States that provide coverage for the duration of pregnancy would 
be required, in accordance with Sec.  457.770(a), to include this 
population of CHIP beneficiaries when reporting on quality measures in 
the Child Core Set. If such State reports on the behavioral health 
measures in the Adult Core Set, or any other Adult Core Set measures 
for their CHIP population, pregnant individuals receiving coverage for 
the duration of pregnancy would be included in such reporting if they 
meet the age parameters for the measure. We believe that reporting on 
the quality of health care provided to the pregnant individual for the 
duration of their pregnancy, based on the age of that individual, would 
provide a more accurate picture of the specific needs of this 
population and the quality of critical health care services received by 
pregnant individuals in CHIP. We seek comment on including pregnant 
individuals receiving coverage under the special CHIP child assistance 
in the requirements for mandatory reporting of measures in the Child 
Core Set as described previously in this proposed rule, based on the 
age of the pregnant individual.
    To ensure that States and CMS can measure and improve the quality 
of care provided to all CHIP beneficiaries, in States that have 
extended CHIP coverage to targeted low-income pregnant women, we 
encourage reporting on not only the behavioral health measures, but all 
measures in the Adult Core Set. In light of the increasing rates of 
maternal morbidity and mortality in the United States, highlighted, but 
not limited to, non-Hispanic black women whose rate of maternal 
mortality was 55.3 deaths per 100,000 live births, 2.9 times the rate 
for non-Hispanic white women in 2020, it is more important than ever to 
collect information on the health of pregnant and postpartum women in 
CHIP and the care provided to them.\61\
---------------------------------------------------------------------------

    \61\ https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/maternal-mortality-rates-2020.htm.
---------------------------------------------------------------------------

F. Ensuring Compliance With the Mandatory Reporting Requirements

    Section 1904 of the Act and implementing regulations at Sec.  
430.35 allow CMS to withhold Federal Medicaid payments, in whole or in 
part, from a State that is non-compliant with Federal requirements 
under section 1902 of the Act. The mandate to begin reporting Child and 
Adult Core Sets measures is set forth in sections 1139A and 1139B of 
the Act, and it is not cross-referenced in section 1902 of the Act. 
Similarly, sections 1945 and 1945A of the Act, which authorize the two 
Medicaid health home benefits to which this proposed rule would apply, 
are not cross-referenced in section 1902 of the Act. However, section 
1902(a)(6) of the Act requires the Medicaid State plan to provide that 
the State agency will make such reports, in such form and containing 
such information, as the Secretary may from time to time require, and 
comply with such provisions as the Secretary may from time to time find 
necessary to assure the correctness and verification of such reports. 
And, as discussed previously in this proposed rule, section 1902(a)(6) 
of the Act also forms part of the authority for our proposed State 
reporting requirements related to the Child, Adult, and Health Homes 
Core Sets. Based on our authority at section 1902(a)(6) of the Act, we 
propose at Sec.  437.20(a) to require the Medicaid State plan to 
include language attesting that the agency would report on the Child, 
Adult, and Health Home Core Sets in accordance with the requirements in 
Sec.  437.15. Health Home SPAs, under proposed Sec.  437.20(a)(3), 
would also be required to include an attestation that the State would 
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

[[Page 51320]]

Act to withhold Federal Medicaid payments if an agency fails to comply 
with the Medicaid reporting requirements.
    Current Sec.  457.204 provides for financial withholding in the 
event of noncompliance with CHIP regulations at part 457. Thus, once 
the mandatory quality Child Core Set reporting requirement is codified 
at Sec.  457.770, CMS would be able to withhold Federal funds under 
Title XXI for noncompliance with the reporting requirement in CHIP.
    To meet the quality measures reporting requirements proposed in 
this rule at Sec.  437.10 through Sec.  437.20, States may need to make 
changes to one or more State systems. As such, we also propose to 
revise the requirements set out at Sec.  433.112 that States must meet 
in order to receive enhanced Federal Medicaid match for systems 
development (at a 90 percent matching rate) and operations (at a 75 
percent matching rate). We propose to add to the requirements at Sec.  
433.112 that States must comply with the standards and protocols for 
reporting on the Child, Adult, and Health Home Core Sets as adopted by 
the Secretary under sections 1139A, 1139B, 1902(a)(6), 1945(c)(4)(B) 
and (g), and 1945A(g) of the Act and 42 CFR part 437 subpart A. As 
noted above, State expenditures on systems development or modifications 
necessary for efficient collection and reporting on the Child Core Set 
are matched at the State's FMAP under section 1905(b) of the Act.
    We believe this proposed requirement would not only incentivize 
adequate systems development to achieve compliance with the proposed 
quality reporting requirements, but would also improve States' ability 
to comply with the proposed reporting requirements. Availability of 
financial penalties would provide us with leverage to enforce quality 
measure reporting, which is foundational to improving the quality and 
health outcomes for Medicaid and CHIP beneficiaries. While enhanced 
match for systems development and maintenance is not available for 
CHIP, it is likely that compliance in CHIP and Medicaid would occur in 
tandem, as States generally use the same system for reporting measures 
for both programs. In the event this does not happen in a given State, 
withholding Federal funds under the CHIP regulations would remain an 
option for CMS to pursue.
    We also propose other changes to Sec.  433.112. These proposed 
changes 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 transactions standards under 45 CFR part 162, and the 
health information technology standards under 45 CFR part 170 subpart B 
to the Core Sets. In 1996, Congress enacted HIPAA,\62\ which included 
Administrative Simplification provisions requiring the establishment of 
national standards \63\ to protect the privacy and security of 
individuals' health information, establishing civil money and criminal 
penalties for violations of the requirements, and electronic 
transactions standards, among other provisions.\64\ The Administrative 
Simplification provisions and implementing regulations apply to covered 
entities, which are health care providers who conduct covered health 
care transactions electronically, health plans, and health care 
clearinghouses.\65\ The Health Information Technology for Economic and 
Clinical Health Act of 2009 (HITECH Act) \66\ added breach notification 
requirements and created penalty tiers for HIPAA violations and also 
authorized the health information technology standards promulgated at 
45 CFR part 170 subpart B.
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    \62\ See Public Law 104-191, 110 Stat. 1936 (August 21, 1996).
    \63\ See also sec. 264 of HIPAA (codified at 42 U.S.C. 1320d-2 
note).
    \64\ See 42 U.S.C. 1320d-1-1320d-9. With respect to privacy 
standards, Congress directed the Department to address at least the 
following: (1) The rights that an individual who is a subject of 
individually identifiable health information should have. (2) The 
procedures that should be established for the exercise of such 
rights. (3) The uses and disclosures of such information that should 
be authorized or required. 42 U.S.C. 1320d-2 note.
    \65\ See 42 U.S.C. 1320d-1 (applying Administrative 
Simplification provisions to covered entities); 45 CFR 160.103 
(definition of ``Covered entity'').
    \66\ Title XIII of Division A and Title IV of Division B of the 
American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-
5).
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    Additionally, we propose to refer to ``standards and implementation 
specifications for health information technology'' rather the existing 
term, ``industry standards.'' The present text refers to ``industry 
standards'' that have been adopted in accordance with 45 CFR part 170, 
subpart B. Subpart B of part 170 is titled ``Standards and 
Implementation Specifications for Health Information Technology,'' so 
we propose this change to Sec.  433.112 to conform to that title.

III. Solicitation of Public Comment

    Throughout sections I. and II. of this proposed rule, we have 
identified a number of technical implementation considerations and 
requested comment on the appropriateness of the processes described to 
fulfill the proposed requirements for mandatory reporting. 
Additionally, we have requested input on the types of technical 
assistance and support which would be most useful for States in meeting 
the proposed requirements for mandatory reporting. We are seeking both 
general comments on the proposed rule as well as comments on specific 
topic areas identified in sections I. and II. of this proposed rule.
    Specifically, we are requesting comments on:
    1. The proposed phased-in approach to stratifying measures, and 
whether 5 years is the right amount of time to phase-in stratification. 
Also, whether the Secretary should establish which measures would have 
to be stratified each year and by what factors or if States should 
decide what measures and factors for which they would submit stratified 
data. (Section II.C.2. of this proposed rule.)
    2. The burden of requiring stratification based on delivery system, 
health plan, and population subgroup for the Child and Adult Core Sets 
and by population subgroup for both the section 1945 and section 1945A 
Health Home Core Sets, and the burden of stratified reporting by race, 
ethnicity, and other demographic factors for all Core Sets. In 
addition, we seek comments on the technical assistance that would be 
needed to support stratified State reporting. (Section II.C.2. of this 
proposed rule.)
    3. The use of T-MSIS TAF or other alternate data sources for Core 
Sets reporting and on CMS reporting on States' behalf. (Section II.D. 
of this proposed rule.)
    4. Requiring adherence to reporting guidance outlined in section 
II.D.1. of this proposed rule.
    5. The most effective technical assistance CMS could provide to 
States to support their transition to standardized mandatory reporting, 
including:
    a. What technical assistance States have found helpful in the past, 
such as one-on-one sessions, written guidance, measure specification 
and coding assistance, site visits, webinars, learning collaboratives, 
opportunities to hear best practices and from other States, or any 
other ideas. (Section II.D.1. of this proposed rule.)
    b. The type of technical assistance needed in order for States to 
report both health outcomes and survey measures. (Section II.D.2. of 
this proposed rule.)
    c. Whether the identification of promising practices and lessons 
learned would assist States in accurately reporting race, ethnicity, 
and other

[[Page 51321]]

demographic data; data linkages; and programmatic requirements. 
(Section II.D.2. of this proposed rule.)
    d. What technical assistance would most assist States so they can 
report on all populations specified by the Secretary each year for the 
Medicaid, CHIP, and Health Home Core Sets, and ultimately, so that they 
can report on all Medicaid, CHIP, and health home program beneficiary 
populations, as well as on how long States might need to be able to 
report on all Medicaid, CHIP, and health home program beneficiary 
populations. (Section II.D.3. of this proposed rule.)
    e. How best to provide technical assistance to States to address 
data issues related to different reporting guidance or data sources 
between separate CHIP and Medicaid. (Section II.D.4. of this proposed 
rule.)
    6. How best to phase-in reporting of health outcomes and survey 
measures for Medicaid and CHIP and the frequency of reporting these 
measures (that is, annually or biennially). (Section II.D.2. of this 
proposed rule.)
    7. Whether States with separate CHIPs should combine Medicaid and 
separate CHIP Child Core Set reporting in order to ensure that children 
who transition between programs are not lost and, if so, the 
attribution rules to determine in which program a child who 
transitioned between Medicaid and CHIP during the reporting period 
should be included. (Section II.D.4. of this proposed rule.)
    8. Include in the requirements for mandatory reporting of measures 
in the Child Core Set pregnant individuals receiving coverage under the 
special CHIP child assistance. (Section II.E. of this proposed rule.)

IV. 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 purposes 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.
    We are soliciting public comment on each of these issues for the 
following sections of this rule that contain information collection 
requirements.

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2020 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 overhead (calculated at 100 percent of salary) and our 
adjusted hourly wage.

                          Table 1--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code         wage ($/hr)    overhead ($/   hourly wage ($/
                                                                                        hr)             hr)
----------------------------------------------------------------------------------------------------------------
Business Operations Specialists.................         13-1000           37.66           37.66           75.32
Chief Executives................................         11-1011           95.12           95.12          190.24
Computer Programmers............................         15-1251           45.98           45.98           91.96
Data Entry/Information Processing Workers.......         43-9020           17.96           17.96           35.92
General Operations Manager......................         11-1021           60.45           60.45          120.90
Statistician....................................         15-2041           46.72           46.72           93.44
----------------------------------------------------------------------------------------------------------------

    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 take into 
account the Federal government's contribution to the cost of 
administering the Medicaid and CHIP programs. The Federal government 
provides funding based on a 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, in that the FMAP for each territory 
under Medicaid is statutorily set at 55 percent, though the rate has 
been increased temporarily in recent years, and annual funding is 
capped.\67\ For Medicaid, all States (including the territories) 
receive a 50 percent Federal Financial Participation (FFP) for 
administration. As noted previously, States also receive higher Federal 
matching rates for certain services and for certain systems 
improvements, redesign, or operations. As such, in taking into account 
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.
---------------------------------------------------------------------------

    \67\ Section 1905(b) of the Act: https://www.ssa.gov/OP_Home/ssact/title19/1905.htm.
---------------------------------------------------------------------------

    To derive average costs for individuals, we used U.S. census data 
to assume an average household income of $41,664, or 200 percent of the 
poverty threshold of $20,832 for a family of three. Assuming 2,088 work 
hours per year, this translates to an hourly rate of $19.95/hr. Unlike 
our private sector adjustment to the respondent hourly wage, we are not 
adjusting this figure for fringe benefits and overhead since the 
individuals' activities would occur outside the scope of their 
employment.

[[Page 51322]]

B. Proposed Information Collection Requirements (ICRs)

    The following proposed collection of information requirements and 
burden will be submitted to OMB for review under control number 0938-
1188 (CMS-10434 #26 for the Child Core Set and the Adult Core Set and 
#47 for the Health Home Core Sets) and applies to the burden associated 
with mandatory reporting. The burden for reporting Adult Core Set 
measures (outside of behavioral health measures) which remain voluntary 
for States to report is not included in the ICRs. Subject to renewal, 
the control number is currently set to expire on July 31, 2023. The 
burden to health home providers for reporting Health Home Core Sets 
data to States is not included in the ICRs but is included in control 
number 0938-1188 (CMS-10434 #22) which is in the process of being 
updated to cover additional benefits and requirements that have been 
added under section 1945A of the Act.
    Under sections 1139A, 1139B, and 1902(a)(6) of the Act, we are 
granted the authority to collect quality metrics on State-specific 
Medicaid and CHIP programs with 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, we are also proposing to require States 
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 would 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.
    At the current time, Child, Adult, and section 1945 Health Home 
Core Sets reporting is voluntary but highly encouraged. Under this 
proposed rule, our voluntary annual reporting requirements would become 
mandatory 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).\68\ This proposed rule does not add, remove, or revise any of the 
existing measures in the current Core Sets. Annual updates to the Core 
Sets would continue to be made as required by sections 1139A and 1139B 
of the Act for the Child and Adult Core Sets and as proposed to be 
applied to both Health Home Core Sets as described in section I.C. of 
this proposed rule. Mandatory reporting of the Child Core Set and 
behavioral health measures on the Adult Core Set would impact all 50 
States, DC, Puerto Rico, Guam, and the Virgin Islands as described in 
section II.A. of this proposed rule. The Health Home Core Sets 
requirements would 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, 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 Health Home SPAs.
---------------------------------------------------------------------------

    \68\ Core Set Measure lists: https://www.medicaid.gov/medicaid/quality-of-care/index.html.
---------------------------------------------------------------------------

    Under this proposed 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 proposed rule. This is 
due to the mandatory nature of the proposed 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, CMS has 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 would become mandatory, two 
of which CMS currently reports for States and Puerto Rico using 
alternate data sources, and the remainder would remain voluntary for 
States to report. CMS is currently assessing whether T-MSIS could be 
used to report any of the remaining measures. If so, this would reduce 
the number of measures that States would be required to calculate.
    The data fields included in Core Set reporting templates are 
determined by the measure stewards who own the measures. CMS is not the 
measure steward for most measures, and therefore does not control the 
actual data fields for most of the measures on the Core Sets. As a 
result, the templates used for Core Sets reporting will not be 
published for public comment. Measure stewards implement a separate 
process for public comment during measure development and measurement 
updates. CMS also has recommendations in the CMS Measures Management 
System Blueprint for a similar process for public comment during 
measure development.\69\
---------------------------------------------------------------------------

    \69\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.
---------------------------------------------------------------------------

1. ICRs Regarding Attestation of Mandatory Reporting (Sec.  437.20(a))
    The following proposed changes will be submitted to OMB for their 
review under control number 0938-1188 (CMS-10434 #26 and CMS-10434 
#47).
    With the changes outlined in this proposed rule, each of the 54 
States and territories that would be subject to the proposed Child and 
Adult Core Set reporting requirements would need to submit a single SPA 
attesting: that the agency would 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 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 in accordance with the 
requirements in Sec.  437.20(a).
    We estimate it would take a business operations specialist 2 hours 
at $75.32/hr and a general operations manager 1 hour at $120.90/hr to 
update and submit the State or territory SPA to CMS for review. We 
estimate a one-time burden of 162 hours (54 States and territories x 3 
hr/response) at a cost of $14,688 (54 States and territories x ([2 hr/
response x $75.32/hr] + [1 hr/response x $120.90/hr])). Taking into 
account the Federal contribution to Medicaid and CHIP program 
administration, the estimated State share of this cost would be $7,332 
($14,663 x 0.50).
    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 proposed changes will be submitted to OMB for their 
review

[[Page 51323]]

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 fiscal year 2024. As referenced in in 
section II.A. of this proposed rule, mandatory reporting of the Child 
Core Set would be required for all 50 States, DC, Puerto Rico, Guam, 
and the Virgin Islands. The data collection, as explained in section 
II.C.1 of this proposed rule, would 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.\70\ 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.\71\ 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.
---------------------------------------------------------------------------

    \70\ https://www.medicaid.gov/chip/downloads/chip-map.pdf.
    \71\ 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: 
118 hours at $91.96/hr for a computer programmer to re-program and 
synthesize the data; 20 hours at $93.44/hr for a statistician to 
conduct data sampling; 79 hours at $120.90/hr for a general operations 
manager to analyze the data; 210.5 hours at $35.92/hr for a data entry 
worker to input the data; and 8.75 hours at $190.24/hr for a chief 
executive to verify, certify, and approve a State data submission to 
CMS.\72\ We estimate an annual burden of 6,108 hours (436.25 hr x 14 
responses) at a cost of $440,957 (14 responses x ([118 hr x $91.96/hr] 
+ [20 hr x $93.44/hr] + [79 hr x $120.90/hr] + [210.5 hr x $35.92/hr] + 
[8.75 hr x $190.24/hr])).
---------------------------------------------------------------------------

    \72\ 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 $120.90/hr for a general operations 
manager to draft a vendor contract and 2 hours at $190.24/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 $15,482 (14 responses x ([6 hr x $120.90/hr] + [2 hr x 
$190.24/hr])).
    In aggregate, for States with Medicaid expansion CHIP only, we 
estimate an annual State burden of 6,220 hours (6,108 hr + 112 hr) at a 
cost of $456,439 ($440,957 + $15,482).
    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: 211 hours at $91.96/hr for a computer programmer 
to collect and synthesize the data; 40 hours at $93.44/hr for a 
statistician to conduct data sampling; 133 hours at $120.90/hr for a 
general operations manager to analyze the data; 419 hours at $35.92/hr 
for a data entry worker to input the data; and 13 hours at $190.24/hr 
for a chief executive to verify, certify, and approve a State data 
submission to CMS. We estimate an annual burden of 32,640 hours (816 hr 
x 40 responses) at a cost of $2,269,778 (40 responses x ([211 hr x 
$91.96/hr] + [40 hr x $93.44/hr] + [133 hr x $120.90/hr] + [419 hr x 
$35.92/hr] + [13 x $190.24/hr])).
    Additionally, we expect the new reporting mandate would require 
vendor contract modifications. We expect the contract modifications to 
take 6 hours at $120.90/hr for a general operations manager to draft a 
vendor contract and 2 hours at $190.24/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 $44,235 (40 
responses x ([6 hr x $120.90/hr] + [2 hr x $190.24/hr])).
    In aggregate, for States with separate CHIPs and States with both 
Medicaid Expansion and separate CHIPs, we estimate an annual State 
burden of 32,960 hours (32,640 hr + 320 hr) at a cost of $2,314,013 
($2,269,778 + $44,235).
    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 $19.95/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 would 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) at a cost of $2,713 (136 hr x $19.95/hr).
    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 822 beneficiary responses/
State) at a cost of $5,406 (271 hr x $19.95/hr).
    For States to administer the survey, we estimate an ongoing 
aggregate beneficiary burden of 12,749 hours [(136 hours x 14 
responses) + (271 hours x 40 responses)] at a cost of $254,243 [($2,713 
x 14 responses) + ($5,406 x 40 responses)].
3. ICRs Regarding Core Set of Adult Health Care Quality Measures for 
Medicaid (Adult Core Set) (Part 437, Subpart A)
    The following proposed changes will be submitted to OMB for their 
review under control number 0938-1188 (CMS-10434 #26).

[[Page 51324]]

    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 fiscal year 2024. As referenced in 
section II.A. of this proposed rule, mandatory reporting of the Adult 
Core Set would be required for all 50 States, DC, Puerto Rico, Guam, 
and the Virgin Islands. The data collection, as explained in section 
II.C.1 of this proposed rule, would 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.
    For the behavioral health measures on the Adult Core Set, 
consisting of approximately 13 measures, we estimate it would take: 85 
hours at $91.96/hr to for a computer programmer to re-program and 
synthesize the data; 20 hours at $93.44/hr for a statistician to 
conduct data sampling; 46 hours at $120.90/hr for a general operations 
manager to analyze the data; 207 hours at $35.92/hr for a data entry 
worker to input the data; and 4 hours at $190.24/hr for a chief 
executive to verify, certify, and approve a State data submission to 
CMS.\73\ We estimate an annual burden of 19,548 hours (362 hr/response 
x 54 responses) at a cost of $1,265,933 (54 responses x ([85 hr x 
$91.96/hr] + [20 hr x $93.44/hr] + [46 hr x $120.90/hr] + [207 hr x 
$35.92/hr] + [4 x $190.24/hr])).
---------------------------------------------------------------------------

    \73\ 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 $120.90/hr for a general operations manager to draft a 
vendor contract and 2 hours at $190.24/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 $59,718 (54 
responses x ([6 hr x $120.90/hr) + [2 hr x $190.24/hr])).
    In aggregate, we estimate an annual State burden of 19,980 hours 
(19,548 hr + 432 hr) at a cost of $1,325,650 ($1,265,933 + $59,718).
    The CAHPS measure is the only mandatory measure on the Adult Core 
Set which would include a burden on beneficiaries.\74\ We estimate it 
would take 20 minutes (0.33 hr) at $19.95/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 $2,713 (136 hr x $19.95/hr). 
For States to administer the survey, In aggregate, we estimate an 
annual beneficiary burden of 7,324 hours (136 hr/State x 54 States) at 
a cost of $146,513 ($2,713 per State x 54 States).
---------------------------------------------------------------------------

    \74\ The Agency for Healthcare Research and Quality is the 
measure steward for the CAHPS survey (CAHPS health plan database OMB 
Control No.: 0935-0165).
---------------------------------------------------------------------------

4. ICRs Regarding Core Sets of Health Home Quality Measures for 
Medicaid (Health Home Core Sets) (Part 437, Subpart A)
    The following proposed changes will be submitted to OMB for their 
review 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 and is covered under control number 0938-1188 
(CMS-10434 #22); however, we will be submitting a revision to that 
burden estimate to cover additional benefits and requirements that have 
been added under section 1945A of the Act.
    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 CMS relies 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 would 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 proposed 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.1 
of this proposed rule, would be required to include: reporting on all 
mandatory measures following the reporting guidance provided by CMS; 
populations on which States must report for each measure; 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 
$91.96/hr for a computer programmer to collect and synthesize the data; 
52 hours at $120.90/hr for a general operations manager to analyze the 
data; 6.5 hours at $35.92/hr for a data entry worker to input the data; 
and 6.5 hours at $190.24/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 $501,560 (40 
responses x ([52 hr x $91.96/hr] + [52 hr x $120.90/hr] + [6.5 hr x 
$35.92/hr] + [6.5 x $190.24/hr])).
    Additionally, we expect the new reporting mandate would require 
vendor contract modifications. We expect the contract modifications to 
take 6 hours at $120.90/hr for a general operations manager to draft a 
vendor contract and 2 hours at $190.24/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 $44,235 (40 
responses x ([6 hr x $120.90/hr) + [2 hr x $190.24/hr])).
    In aggregate, we estimate an annual burden of 5,000 hours (5,680 hr 
+ 320 hr) at a cost of $545,795 ($501,560 + $44,235).
    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.
    Section 1945A Authority: CMS anticipates that the section 1945A 
Health Home Core Set for section 1945A

[[Page 51325]]

programs would consist of approximately 7 measures. For each respondent 
with this program, we estimate it would take: 28 hours at $91.96/hr for 
a computer programmer to collect and synthesize the data; 28 hours at 
$120.90/hr for a general operations manager to analyze the data; 3 
hours at $35.92/hr for a data entry worker to input the data; and 3 
hours at $190.24/hr for a chief executive to verify, certify, and 
approve a State data submission to CMS. We estimate an annual State 
burden of 620 hours (62 hr/response x 10 responses) at a cost of 
$66,386 (10 responses x ([28 hr x $91.96/hr] + [28 hr x $120.90/hr] + 
[3 hr x $35.92/hr] + [3 x $190.24/hr])).
    Additionally, we expect the new reporting mandate would require 
vendor contract modifications. We expect the contract modifications to 
take 6 hours at $120.90/hr for a general operations manager to draft a 
vendor contract and 2 hours at $190.24/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 $11,059 (10 
responses x ([6 hr x $120.90/hr) + [2 hr x $190.24/hr])).
    In aggregate, we estimate an annual State burden of 700 hours (620 
hr + 80 hr) at a cost of $77,444 ($66,386 + $11,059).
    Note that CMS anticipates 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.

C. Summary of Proposed Requirements and Annual Burden Estimates

    Table 2 sets out our proposed annual burden estimates.

                                                   Table 2--Summary of Annual Requirements and Burden
                                                            [(OMB Control Number: 0938-1188]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Time per                                                     Adjusted  cost
  Section 437 under Title 42 of the CFR      Number of         Total         response       Total time    Labor cost  ($/   Total cost    ($)  (50% FMAP
                                            respondents      responses        (hours)         (hours)           hr)             ($)           or FFP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      CMS-10434 #26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   437.20 One-time SPA Submission *.              54              54               2             108             181           9,774           4,887
Sec.   437.15 (Child Core Set)..........              54              54          Varies          39,180          Varies       2,770,452       1,385,226
Sec.   437.15 (Adult Core Set)..........              54              54             370          19,980          24,549       1,325,650         662,825
Subtotal (#26)..........................              54              54          Varies          59,268          Varies       4,105,876       2,052,938
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      CMS-10434 #47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   437.20 One-time SPA Submission *.              54              54               1              54              91           4,914           2,457
Sec.   437.15 (1945 Health Home Core                  40              40             125           5,000          13,645         545,795         272,898
 Set)...................................
Sec.   437.15 (1945A Health Home Core                 10              10              70             700           7,744          77,440          38,720
 Set)...................................
Subtotal (#47)..........................              50              50          Varies           5,754          Varies         628,149         314,075
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................          Varies              54          Varies          65,022          Varies       4,734,025       2,367,013
--------------------------------------------------------------------------------------------------------------------------------------------------------
* States will be required to submit a single 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.

D. Submission of PRA-Related Comments

    We have submitted a copy of this proposed rule to OMB for its 
review of the rule's information collection requirements and burden. 
The requirements are not effective until they have been approved by 
OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections discussed above, please visit the CMS 
website at www.cms.hhs.gov/PaperworkReductionActof1995, or call the 
Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements. If you wish to comment, please submit your comments 
electronically as specified in the DATES and ADDRESSES section of this 
proposed rule and identify the rule (CMS-2440-P) the ICR's CFR 
citation, and OMB control number.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. 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), 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). A regulatory impact analysis (RIA) 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). This rule does not reach the 
economic threshold and thus is not considered a major rule. 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

[[Page 51326]]

States are not included in the definition of a small entity. This 
proposed 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 proposed 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 603 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 proposed rule with comment period 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 2021, that 
threshold is approximately $165 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 July 5, 2022.

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 proposes to amend 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 of

[[Page 51327]]

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--
    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 and 
treatment 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.
    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).


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 Core Sets;
    (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; are feasible for 
State-level and/or Health Home program level reporting as appropriate; 
and represent minimal additional burden to States.
    (3) In consultation with States, develop and update annually the 
reporting guidance described in paragraph (b) of this section.
    (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 measures, if any, for which the Secretary will provide 
States with additional time to report, as well as how much additional 
time the Secretary will provide, in accordance with paragraph (c) of 
this section.
    (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 must report 
the measures identified by the Secretary under paragraph (b)(1) of this 
section, including, but not limited to beneficiaries--
    (i) Receiving services through specified delivery systems, such as 
those enrolled in a managed care plan or receiving services on a fee-
for-service basis;
    (ii) Receiving services through specified health care settings and/
or provider types, such as hospitals, outpatient facilities, Federally 
Qualified Health Centers and other safety-net providers, rural health 
clinics, Indian Health Service, Tribes and Tribal Organizations, or 
Urban Indian Organizations; and
    (iii) Who are dually eligible for Medicare and Medicaid, including 
beneficiaries whose medical assistance is limited to payment of 
Medicare premiums and/or cost sharing.
    (6) Attribution rules for determining how States must report on 
measures for beneficiaries who are included in more than one 
population, as described in paragraph (b)(5) of this section, during 
the reporting period.
    (7) The subset of measures among 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 mandatory State reporting for 
certain measures and reporting for certain populations of beneficiaries 
will be phased in over a specified period of time, taking into account 
the level of complexity required for such State reporting; and
    (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 take into account 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 will require 
stratification of 25 percent of the measures on each of the Core Sets 
(the Child Core Set, behavioral health

[[Page 51328]]

measures within the Adult Core Set, and Health Homes 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; and
    (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 paragraph (a)(2) and 
(4) of this section, the agency--
    (i) 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) of this subpart;
    (ii) 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) of this subpart, 
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
    (iii) May report on all other measures in the Adult Core Set and 
Health Home Core Sets 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 Core Sets measures, the agency may, but is 
not required to:
    (i) Report on the measures identified by the Secretary pursuant to 
Sec.  437.10(c) for which reporting will be, but is not yet required 
(that is, reporting has not yet been phased-in).
    (ii) Report on the populations identified by the Secretary pursuant 
to Sec.  437.10(c) for whom reporting will be, but is not yet required.
    (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) Individuals enrolled in Medicaid who are within the measure 
specified age range for each measure (inclusive of individuals for whom 
the State claims the enhanced Federal Medicaid Assistance Percentage 
under Sec.  433.11(a) of part 433 of this subchapter) as per reporting 
guidance described in paragraph Sec.  437.10(b)(2); and
    (ii) Individuals who are in the measure specified age range for 
each measure who are enrolled in Medicaid or the State's separate CHIP 
beneficiaries 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; and;
    (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 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) removing the period at the end of the paragraph 
and adding in its place ``; and''; and
0
c. Adding new 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 subpart G 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

[[Page 51329]]

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 both separately from and combined with Medicaid 
beneficiaries (including title XXI funded Medicaid beneficiaries) in 
accordance with Sec.  437.15(b) of this chapter.

    Dated: August 15, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-17810 Filed 8-18-22; 4:15 pm]
BILLING CODE 4120-01-P