Home/Federal/Federal Register/2022-17810

Proposed Rule2022-17810

Medicaid Program and CHIP; Mandatory Medicaid and Children's Health Insurance Program (CHIP) Core Set Reporting

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published

August 22, 2022

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

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.

Full Text

<html>
<head>
<title>Federal Register, Volume 87 Issue 161 (Monday, August 22, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17810]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> 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).
---------------------------------------------------------------------------

\1\ March 2022 Medicaid and CHIP Enrollment data: <a href="https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/march-2022-medicaid-chip-enrollment-trend-snapshot.pdf">https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/march-2022-medicaid-chip-enrollment-trend-snapshot.pdf</a>.
---------------------------------------------------------------------------

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

\2\ Initial Child Core Set: <a href="https://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/SHO11001.pdf">https://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/SHO11001.pdf</a>.
---------------------------------------------------------------------------

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

\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: <a href="https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/cib-01-04-12.pdf">https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/cib-01-04-12.pdf</a>.
---------------------------------------------------------------------------

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

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

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

\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 <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/SMD10024.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/SMD10024.pdf</a>.
\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 <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/smd22004.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/smd22004.pdf</a>.
---------------------------------------------------------------------------

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

\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),'' <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/cib050719.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/cib050719.pdf</a>. 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, <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf</a>.
\10\ <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/smd-13-001.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/smd-13-001.pdf</a>.
---------------------------------------------------------------------------

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

\11\ https://www.medicaid.gov/federal-policy-guidance/downloads/
SMD-13-001.pdf.
---------------------------------------------------------------------------

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

\12\ <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf</a>
---------------------------------------------------------------------------

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

\13\ Annual Review and Selection Process: <a href="https://www.medicaid.gov/medicaid/quality-of-care/downloads/annual-core-set-review.pdf">https://www.medicaid.gov/medicaid/quality-of-care/downloads/annual-core-set-review.pdf</a>.
---------------------------------------------------------------------------

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

\14\ Child and Adult Core Sets Annual Report: <a href="https://www.mathematica.org/features/maccoresetreview">https://www.mathematica.org/features/maccoresetreview</a>.
\15\ Health Home Core Set Annual Review: <a href="https://www.mathematica.org/features/hhcoresetreview">https://www.mathematica.org/features/hhcoresetreview</a>.
---------------------------------------------------------------------------

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 <a href="http://Medicaid.gov">Medicaid.gov</a>.
---------------------------------------------------------------------------

\16\ The public comment period for the Annual Workgroup report
is 30 days.
---------------------------------------------------------------------------

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
---------------------------------------------------------------------------

\17\ Child Core Set Reporting: <a href="https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html">https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html</a>.
\18\ Adult Core Set Reporting: <a href="https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-care-quality-measures/index.html">https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-care-quality-measures/index.html</a>.
---------------------------------------------------------------------------

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
---------------------------------------------------------------------------

\20\ Quality Improvement Initiatives: <a href="https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/index.html">https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/index.html</a>.
\21\ Asthma Learning Collaborative: <a href="https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/improving-asthma-control-learning-collaborative/index.html">https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/improving-asthma-control-learning-collaborative/index.html</a>.
\22\ Oral Health Learning Collaborative: <a href="https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/advancing-prevention-and-reducing-childhood-caries-medicaid-and-chip-learning-collaborative/index.html">https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/advancing-prevention-and-reducing-childhood-caries-medicaid-and-chip-learning-collaborative/index.html</a>.
\23\ Maternal and Infant Health Quality Initiative: <a href="https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/maternal-infant-health-care-quality/index.html">https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/maternal-infant-health-care-quality/index.html</a>.
\24\ Scorecard: <a href="https://www.medicaid.gov/state-overviews/scorecard/state-health-system-performance/index.html">https://www.medicaid.gov/state-overviews/scorecard/state-health-system-performance/index.html</a>.
\25\ Medicaid Managed Care Quality: <a href="https://www.medicaid.gov/medicaid/quality-of-care/medicaid-managed-care-quality/index.html">https://www.medicaid.gov/medicaid/quality-of-care/medicaid-managed-care-quality/index.html</a>.
---------------------------------------------------------------------------

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: <a href="https://www.ssa.gov/OP_Home/ssact/title11/1139B.htm">https://www.ssa.gov/OP_Home/ssact/title11/1139B.htm</a>, 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\
---------------------------------------------------------------------------

\27\ Definition of behavioral health for Certified Community
Behavioral Health Clinics: <a href="https://www.samhsa.gov/sites/default/files/programs_campaigns/ccbhc-criteria.pdf">https://www.samhsa.gov/sites/default/files/programs_campaigns/ccbhc-criteria.pdf</a>.
\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): <a href="https://www.law.cornell.edu/uscode/text/25/1603#2_A">https://www.law.cornell.edu/uscode/text/25/1603#2_A</a>, <a href="https://www.govinfo.gov/content/pkg/USCODE-2011-title25/pdf/USCODE-2011-title25-chap18.pdf">https://www.govinfo.gov/content/pkg/USCODE-2011-title25/pdf/USCODE-2011-title25-chap18.pdf</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.cms.gov/outreach-education/american-indianalaska-native/aian-behavioral-health">https://www.cms.gov/outreach-education/american-indianalaska-native/aian-behavioral-health</a>.
---------------------------------------------------------------------------

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

\31\ See, for example, Meaningful Measures: <a href="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</a>. <a href="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</a>.
---------------------------------------------------------------------------

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 <a href="https://www.medicaid.gov/medicaid/quality-of-care/index.html">https://www.medicaid.gov/medicaid/quality-of-care/index.html</a>.
---------------------------------------------------------------------------

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
---------------------------------------------------------------------------

\34\ Racism and Health. Centers for Disease Control. <a href="https://www.cdc.gov/healthequity/racism-disparities/index.html">https://www.cdc.gov/healthequity/racism-disparities/index.html</a>.
\35\ Improving Data Collection across the Health Care System.
Content last reviewed May 2018. Agency for Healthcare Research and
Quality, Rockville, MD. <a href="https://www.ahrq.gov/research/findings/final-reports/iomracereport/reldata5.html">https://www.ahrq.gov/research/findings/final-reports/iomracereport/reldata5.html</a>.
\36\ Berg S. Improve health equity by collecting patient
demographic data. American Medical Association. 2018. <a href="https://www.ama-assn.org/delivering-care/population-care/improve-health-equity-collecting-patient-demographic-data">https://www.ama-assn.org/delivering-care/population-care/improve-health-equity-collecting-patient-demographic-data</a>.
\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. <a href="https://www.annualreviews.org/doi/full/10.1146/annurevpublhealth-032013-182423">https://www.annualreviews.org/doi/full/10.1146/annurevpublhealth-032013-182423</a>.
\38\ Social Determinants of Health. Healthy People 2030. <a href="https://health.gov/healthypeople/objectives-and-data/social-determinants-health">https://health.gov/healthypeople/objectives-and-data/social-determinants-health</a>.
\39\ CMS, State Health Official Letter #21-001, Opportunities in
Medicaid and CHIP to Address Social Determinants of Health, Jan 7
2021. <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/sho21001.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/sho21001.pdf</a>.
\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: <a href="https://doi.org/10.1111/j.1945-1474.2011.00180.x">https://doi.org/10.1111/j.1945-1474.2011.00180.x</a>.
\42\ Office of the Assistant Secretary for Planning and
Evaluation, Building the Evidence Base for Social Determinants of
Health Interventions, Sep 23 2021. <a href="https://aspe.hhs.gov/reports/building-evidence-base-social-determinants-health-interventions">https://aspe.hhs.gov/reports/building-evidence-base-social-determinants-health-interventions</a>.
\43\ CMS Office of Minority Health. (Updated August 2018). Guide
to Reducing Disparities in Readmissions. Baltimore, MD: Centers for
Medicare & Medicaid Services. <a href="https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf">https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf</a>.

---------------------------------------------------------------------------

[[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
---------------------------------------------------------------------------

\44\ Executive Order 13985: <a href="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/">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/</a>.
\45\ CMS Framework for Health Equity 2022-2032: <a href="https://www.cms.gov/files/document/cms-framework-health-equity.pdf">https://www.cms.gov/files/document/cms-framework-health-equity.pdf</a>.
\46\ CMS Strategic Plan 2022: <a href="https://www.cms.gov/cms-strategic-plan">https://www.cms.gov/cms-strategic-plan</a>.
---------------------------------------------------------------------------

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
---------------------------------------------------------------------------

\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; <a href="https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting">https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting</a>.
\49\ National Quality Forum. A Roadmap for Promoting Health
Equity and Eliminating Disparities. Sep 2017. <a href="https://www.qualityforum.org/Publications/2017/09/A_Roadmap_for_Promoting_Health_Equity_and_Eliminating_Disparities__The_Four_I_s_for_Health_Equity.aspx">https://www.qualityforum.org/Publications/2017/09/A_Roadmap_for_Promoting_Health_Equity_and_Eliminating_Disparities__The_Four_I_s_for_Health_Equity.aspx</a>.
---------------------------------------------------------------------------

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

\50\ CMS Cell Size Suppression Policy, Issued 2020: <a href="https://www.hhs.gov/guidance/document/cms-cell-suppression-policy">https://www.hhs.gov/guidance/document/cms-cell-suppression-policy</a>.
---------------------------------------------------------------------------

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

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

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

\54\ Child and Adult Core Set reporting guidance: <a href="https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/index.html">https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/index.html</a>.
Health Home Core Set reporting guidance: <a href="https://www.medicaid.gov/resources-for-states/medicaid-state-technical-assistance/health-home-information-resource-center/health-home-quality-reporting/index.html">https://www.medicaid.gov/resources-for-states/medicaid-state-technical-assistance/health-home-information-resource-center/health-home-quality-reporting/index.html</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.cms.gov/files/document/medicaremedicaiddualenrollmenteverenrolledtrendsdatabrief.pdf">https://www.cms.gov/files/document/medicaremedicaiddualenrollmenteverenrolledtrendsdatabrief.pdf</a>.
\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 <a href="https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/Dual_Condition_Prevalence_Comorbidity_2014.pdf">https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/Dual_Condition_Prevalence_Comorbidity_2014.pdf</a>.
\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 <a href="https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/StateAccesstoMedicareData">https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/StateAccesstoMedicareData</a> or contact the State
Data Resource Center at <a href="https://www.statedataresourcecenter.com/home/contact-us">https://www.statedataresourcecenter.com/home/contact-us</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.medicaid.gov/medicaid/indian-health-medicaid/index.html">https://www.medicaid.gov/medicaid/indian-health-medicaid/index.html</a>.
---------------------------------------------------------------------------

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 <a href="https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/reporting/2019-uds-manual.pdf">https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/reporting/2019-uds-manual.pdf</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/maternal-mortality-rates-2020.htm">https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/maternal-mortality-rates-2020.htm</a>.
---------------------------------------------------------------------------

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

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

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:
<bullet> The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
<bullet> The accuracy of our estimate of the information collection
burden.
<bullet> The quality, utility, and clarity of the information to be
collected.
<bullet> 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 (<a href="http://www.bls.gov/oes/current/oes_nat.htm">http://www.bls.gov/oes/current/oes_nat.htm</a>). 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: <a href="https://www.ssa.gov/OP_Home/ssact/title19/1905.htm">https://www.ssa.gov/OP_Home/ssact/title19/1905.htm</a>.
---------------------------------------------------------------------------

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: <a href="https://www.medicaid.gov/medicaid/quality-of-care/index.html">https://www.medicaid.gov/medicaid/quality-of-care/index.html</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.medicaid.gov/chip/downloads/chip-map.pdf">https://www.medicaid.gov/chip/downloads/chip-map.pdf</a>.
\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: <a href="https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html">https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/childrens-health-care-quality-measures/index.html</a>.
---------------------------------------------------------------------------

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\ <a href="https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-care-quality-measures/index.html">https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-care-quality-measures/index.html</a>.
---------------------------------------------------------------------------

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 <a href="http://www.cms.hhs.gov/PaperworkReductionActof1995">www.cms.hhs.gov/PaperworkReductionActof1995</a>, 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 deter

[…truncated; see source link]

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on August 22, 2022.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.