Proposed Rule2023-08959
Medicaid Program; Ensuring Access to Medicaid Services
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
May 3, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule takes a comprehensive approach to improving access to care, quality and health outcomes, and better addressing health equity issues in the Medicaid program across fee-for-service (FFS), managed care delivery systems, and in home and community-based services (HCBS) programs. These proposed improvements seek to increase transparency and accountability, standardize data and monitoring, and create opportunities for States to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care.
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<title>Federal Register, Volume 88 Issue 85 (Wednesday, May 3, 2023)</title>
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[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Proposed Rules]
[Pages 27960-28089]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08959]
[[Page 27959]]
Vol. 88
Wednesday,
No. 85
May 3, 2023
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 431, 438, et al.
Medicaid Program; Ensuring Access to Medicaid Services; Proposed Rule
Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 /
Proposed Rules
[[Page 27960]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 431, 438, 441, and 447
[CMS-2442-P]
RIN 0938-AU68
Medicaid Program; Ensuring Access to Medicaid Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule takes a comprehensive approach to improving
access to care, quality and health outcomes, and better addressing
health equity issues in the Medicaid program across fee-for-service
(FFS), managed care delivery systems, and in home and community-based
services (HCBS) programs. These proposed improvements seek to increase
transparency and accountability, standardize data and monitoring, and
create opportunities for States to promote active beneficiary
engagement in their Medicaid programs, with the goal of improving
access to care.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by July 3, 2023.
ADDRESSES: In commenting, please refer to file code CMS-2442-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-2442-P, P.O. Box 8016,
Baltimore, MD 21244-1850.
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-2442-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:
Karen LLanos, (410) 786-9071, for Medical Care Advisory Committee.
Jennifer Bowdoin, (410) 786-8551, for Home and Community-Based
Services.
Jeremy Silanskis, (410) 786-1592, for Fee-for-Service Payment.
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. Overview
Title XIX of the Social Security Act (the Act) established the
Medicaid program as a joint Federal and State program to provide
medical assistance to eligible individuals, including many with low
incomes. Under the Medicaid program, each State that chooses to
participate in the program and receive Federal financial participation
(FFP) for program expenditures, establishes eligibility standards,
benefits packages, and payment rates, and undertakes program
administration in accordance with Federal statutory and regulatory
requirements. The provisions of each State's Medicaid program are
described in the Medicaid ``State plan'' and, as applicable, related
authorities, such as demonstration projects and waivers of State plan
requirements. Among other responsibilities, CMS approves State plans,
State plan amendments (SPAs), demonstration projects authorized under
section 1115 of the Act, and waivers authorized under section 1915 of
the Act; and reviews expenditures for compliance with Federal Medicaid
law, including the requirements of section 1902(a)(30)(A) of the Act
relating to efficiency, economy, quality of care, and access to ensure
that all applicable Federal requirements are met.
As of December 2022, the Medicaid program provides essential health
care coverage to more than 85 million \1\ individuals, and, in 2021,
accounted for 17 percent of national health expenditures.\2\ The
program covers a broad array of health benefits and services critical
to underserved populations,\3\ including low-income adults, children,
parents, pregnant individuals, older adults, and people with
disabilities. For example, Medicaid pays for approximately 41 percent
of all births in the U.S.\4\ and is the largest payer of long-term
services and supports (LTSS),\5\ the largest, single payer of services
to treat substance use disorders,\6\ and services to prevent and treat
the Human Immunodeficiency Virus.\7\
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\1\ December 2022 Medicaid and CHIP Enrollment Snapshot.
Accessed at <a href="https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/December-2022-medicaid-chip-enrollment-trend-snapshot.pdf">https://www.medicaid.gov/medicaid/national-medicaid-chip-program-information/downloads/December-2022-medicaid-chip-enrollment-trend-snapshot.pdf</a>.
\2\ CMS National Health Expenditure Accounts. National Health
Expenditures 2020 Highlight. Accessed at <a href="https://www.cms.gov/files/document/highlights.pdf">https://www.cms.gov/files/document/highlights.pdf</a>.
\3\ 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>.
\4\ National Center for Health Statistics. Key Birth Statistics.
Accessed at <a href="https://www.cdc.gov/nchs/nvss/births.htm">https://www.cdc.gov/nchs/nvss/births.htm</a>.
\5\ Colello, Kirsten J. Who Pays for Long-Term Services and
Supports? Congressional Research Service. Updated June 15, 2022.
Accessed at <a href="https://crsreports.congress.gov/product/pdf/IF/IF10343">https://crsreports.congress.gov/product/pdf/IF/IF10343</a>.
\6\ Soni, Anita. Health Care Expenditures for Treatment of
Mental Disorders: Estimates for Adults Ages 18 and Older, U.S.
Civilian Noninstitutionalized Population, 2019. Statistical Brief
#539, pg 12. February 2022. Agency for Healthcare Research and
Quality, Rockville, MD. Accessed at <a href="https://meps.ahrq.gov/data_files/publications/st539/stat539.pdf">https://meps.ahrq.gov/data_files/publications/st539/stat539.pdf</a>.
\7\ Dawson, L. and Kates, J. Insurance Coverage and Viral
Suppression Among People with HIV, 2018. September 2020. Kaiser
Family Foundation. Accessed at <a href="https://www.kff.org/hivaids/issue-brief/insurance-coverage-and-viral-suppression-among-people-with-hiv-2018/">https://www.kff.org/hivaids/issue-brief/insurance-coverage-and-viral-suppression-among-people-with-hiv-2018/</a>.
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On January 28, 2021, the President signed Executive Order (E.O.)
14009,\8\ ``Strengthening Medicaid and the Affordable Care Act'' which
established the policy objective to protect and strengthen Medicaid and
the Affordable Care Act and to make high-quality health care accessible
and affordable for every American and directed executive departments
and agencies to review existing regulations, orders, guidance
documents, and policies to determine whether such agency actions are
inconsistent with this policy. On April
[[Page 27961]]
5, 2022, E.O. 14070,\9\ ``Continuing To Strengthen Americans' Access to
Affordable, Quality Health Coverage,'' directed Federal agencies with
responsibilities related to Americans' access to health coverage to
review agency actions to identify ways to continue to expand the
availability of affordable health coverage, to improve the quality of
coverage, to strengthen benefits, and to help more Americans enroll in
quality health coverage. This proposed rule aims to fulfill E.O.s 14009
and 14070 by helping States to strengthen Medicaid and improve access
to and quality of care provided.
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\8\ Executive Order 14009: <a href="https://www.federalregister.gov/documents/2021/02/02/2021-02252/strengthening-medicaid-and-the-affordable-care-act">https://www.federalregister.gov/documents/2021/02/02/2021-02252/strengthening-medicaid-and-the-affordable-care-act</a>.
\9\ Executive Order 14070: <a href="https://www.federalregister.gov/documents/2022/04/08/2022-07716/continuing-to-strengthen-americans-access-to-affordable-quality-health-coverage">https://www.federalregister.gov/documents/2022/04/08/2022-07716/continuing-to-strengthen-americans-access-to-affordable-quality-health-coverage</a>.
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Ensuring that beneficiaries can access covered services is
necessary to the basic operation of the Medicaid program. Depending on
the State and its Medicaid program structure, beneficiaries access
their health care services using a variety of care delivery systems
(for example, FFS, fully-capitated managed care, partially capitated
managed care, etc.), including through demonstrations and waiver
programs. In 2020, 70 percent of Medicaid beneficiaries were enrolled
in comprehensive managed care plans; \10\ the remaining individuals
received all of their care or some services that have been carved out
of managed care through FFS.
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\10\ MACPAC 2022 Analysis of T-MSIS data February 2022. Exhibit
30. Percentage of Medicaid Enrollees in Managed Care by State and
Eligibility Group <a href="https://www.macpac.gov/wp-content/uploads/2022/12/EXHIBIT-30.-Percentage-of-Medicaid-Enrollees-in-Managed-Care-by-State-and-Eligibility-Group-FY-2020.pdf">https://www.macpac.gov/wp-content/uploads/2022/12/EXHIBIT-30.-Percentage-of-Medicaid-Enrollees-in-Managed-Care-by-State-and-Eligibility-Group-FY-2020.pdf</a>.
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Current access regulations are neither comprehensive nor consistent
across delivery systems or coverage authority (for example, State plan
and demonstration authority). For example, regulations at 42 CFR
447.203 and 447.204 relating to access to care, service payment rates,
and Medicaid provider participation in rate setting apply only to
Medicaid FFS delivery systems and focus on ensuring that payment rates
are consistent with the statutory requirements in section
1902(a)(30)(A) of the Act. The regulations do not apply to services
delivered under managed care. These regulations are also largely
procedural in nature and rely heavily on States to form an analysis and
reach conclusions on the sufficiency of their own payment rates.
With a program as large and complex as Medicaid, access regulations
need to be multi-factorial to promote consistent access to health care
for all beneficiaries across all types of care delivery systems in
accordance with statutory requirements. Strategies to enhance access to
health care services should reflect how people move through and
interact with the health care system. We view the continuum of health
care access across three dimensions of a person-centered framework: (1)
enrollment in coverage; (2) maintenance of coverage; and (3) access to
services and supports. Within each of these dimensions, accompanying
regulatory, monitoring, and/or compliance actions may be needed to
ensure access to health care is achieved and maintained.
In the spring of 2022, we released a request for information (RFI)
\11\ to collect feedback on a broad range of questions that examined
topics such as: challenges with eligibility and enrollment; ways we can
use data available to measure, monitor, and support improvement efforts
related to access to services; strategies we can implement to support
equitable and timely access to providers and services; and
opportunities to use existing and new access standards to help ensure
that Medicaid and CHIP payments are sufficient to enlist enough
providers.
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\11\ CMS Request for Information: Access to Coverage and Care in
Medicaid & CHIP. February 2022. For a full list of question from the
RFI, see <a href="https://www.medicaid.gov/medicaid/access-care/downloads/access-rfi-2022-questions.pdf">https://www.medicaid.gov/medicaid/access-care/downloads/access-rfi-2022-questions.pdf</a>.
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Some of the most common feedback we received through the RFI
related to ways that we can promote health equity through cultural
competency. Commenters shared the importance that cultural competency
plays in how beneficiaries access health care and in the quality of
health services received by beneficiaries. The RFI respondents shared
examples of actions that we could take, including collecting and
analyzing health outcomes data by sociodemographic categories;
establishing minimum standards for how States serve communities in ways
that address cultural competency and language preferences; and reducing
barriers to enrollment and retention for racial and ethnic minority
groups.
In addition to the topic of cultural competency, commenters also
commonly shared that they viewed reimbursement rates as a key driver of
provider participation in Medicaid and CHIP programs. Further,
commenters noted that aligning payment approaches and setting minimum
standards for payment regulations and compliance across Medicaid and
CHIP delivery systems, services, and benefits could help ensure that
beneficiaries' access to services is as similar as possible across
beneficiary groups, delivery systems, and programs.
As mentioned previously in this proposed rule, the first dimension
of access focuses on ensuring that eligible people are able to enroll
in the Medicaid program. Access to Medicaid enrollment requires that a
potential beneficiary know if they are or may be eligible for Medicaid,
be aware of Medicaid coverage options, and be able to easily apply for
and enroll in coverage. The second dimension of access in this
continuum relates to maintaining coverage once the beneficiary is
enrolled in the Medicaid program initially. Maintaining coverage
requires that eligible beneficiaries are able to stay enrolled in the
program without interruption, or that they know how to and can smoothly
transition to other health coverage, such as CHIP, Exchange coverage,
or Medicare, when they are no longer eligible for Medicaid coverage but
have become eligible for other health coverage programs. In September
2022, we published a proposed rule, Streamlining the Medicaid,
Children's Health Insurance Program, and Basic Health Program
Application, Eligibility, Determination, Enrollment, and Renewal
Processes (87 FR 54760; hereinafter the ``Streamlining Eligibility &
Enrollment proposed rule'') to simplify the processes for eligible
individuals to enroll and retain eligibility in Medicaid, CHIP, and the
Basic Health Program (BHP).
The third dimension, which is the focus of this proposed rule, is
access to services and supports. This rule is focused on addressing
additional critical elements of access: (1) potential access, which
refers to a beneficiary's access to providers and services, whether or
not the providers or services are used; (2) beneficiary utilization,
which refers to beneficiaries' actual use of the providers and services
available to them; and (3) beneficiaries' perceptions and experiences
with the care they did or were not able to receive. These terms and
definitions build upon previous efforts to examine how best to monitor
access.\12\
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\12\ Kenney, Genevieve M., Kathy Gifford, Jane Wishner, Vanessa
Forsberg, Amanda I. Napoles, and Danielle Pavliv. ``Proposed
Medicaid Access Measurement and Monitoring Plan.'' Washington, DC:
The Urban Institute. August 2016. Accessed at <a href="https://www.urban.org/sites/default/files/publication/88081/2001143-medicaid-access-measurement-and-monitoring-plan_0.pdf">https://www.urban.org/sites/default/files/publication/88081/2001143-medicaid-access-measurement-and-monitoring-plan_0.pdf</a>.
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We are engaging in an array of regulatory activities, including
three rulemakings that are currently underway (more specifically, the
Streamlining Eligibility & Enrollment proposed rule, a proposed rule,
entitled
[[Page 27962]]
Medicaid and Children's Health Insurance Program (CHIP) Managed Care
Access, Finance, and Quality, on managed care including matters of
access, and this proposed rule on access). Additionally, we are taking
non-regulatory activities to improve beneficiary access to care (for
example, best practices toolkits and technical assistance to States) to
improve access to health care services across Medicaid delivery
systems.
As noted earlier, we issued the Streamlining Eligibility &
Enrollment proposed rule to address the first two dimensions of access
to health care: (1) enrollment in coverage and (2) maintenance of
coverage. Through that proposed rule, we sought to streamline Medicaid,
CHIP and BHP eligibility and enrollment processes, reduce
administrative burden on States and applicants/enrollees toward a more
seamless eligibility and enrollment process, and increase the
enrollment and retention of eligible individuals.
The managed care proposed rule seeks to improve access to care and
quality outcomes for Medicaid and CHIP beneficiaries enrolled in
managed care by: creating standards for timely access to care and
States' monitoring and enforcement efforts; reducing burden for some
State directed payments and certain quality reporting requirements;
adding new standards that would apply when States use in lieu of
services and settings (ILOSs) to promote effective utilization, and
specifying the scope and nature of ILOS; specifying medical loss ratio
(MLR) requirements, and establishing a quality rating system for
Medicaid and CHIP managed care plans.
Through the managed care proposed rule and this proposed rule
(Ensuring Access to Medicaid Services), we propose additional
requirements to address the third dimension of the health care access
continuum: access to services. The proposed requirements outlined later
in this section focus on improving access to services in Medicaid by
utilizing tools such as FFS rate transparency, standardized reporting
for HCBS, and improving the process for interested parties, especially
Medicaid beneficiaries, to provide feedback to State Medicaid agencies
and for Medicaid agencies to respond to the feedback (also known as a
feedback loop).
Through a combination of these three proposed rules, we seek to
address a range of access-related challenges that impact how
beneficiaries are served by Medicaid across all of its delivery
systems. FFP would be available for expenditures that might be
necessary to implement the activities States would need to undertake to
comply with the provisions of the proposed rules, if finalized.
Finally, we also believe it is important to acknowledge the role of
health equity within this proposed rule. Medicaid plays a
disproportionately large role in covering health care for people of
color in this country.\13\ Consistent with E.O. 13985 on Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government (January 20, 2021),\14\ which calls for advancing
equity for underserved populations, we are working to ensure our
programs consistently provide high-quality care to all beneficiaries,
and thus advance health equity, consistent with the goals and
objectives we have outlined in the CMS Framework for Health Equity
2022-2032 \15\ and the HHS Equity Action Plan.\16\ That effort includes
increasing our understanding of the needs of those we serve to ensure
that all individuals have access to equitable care and coverage.
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\13\ Guth, M. and Artiga, S. Medicaid and Racial Health Equity
March 2022. Accessed at <a href="https://www.kff.org/medicaid/issue-brief/medicaid-and-racial-health-equity/">https://www.kff.org/medicaid/issue-brief/medicaid-and-racial-health-equity/</a>.
\14\ 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>.
\15\ 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>.
\16\ HHS Equity Action Plan. April 2022. Accessed at <a href="https://www.hhs.gov/sites/default/files/hhs-equity-action-plan.pdf">https://www.hhs.gov/sites/default/files/hhs-equity-action-plan.pdf</a>.
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We recognize that each State faces a unique set of challenges
related to the resumption of its normal program acvitities after the
end of the COVID-19 public health emergency (PHE). More specifically,
the expiration of the continuous enrollment condition authorized by the
Families First Coronavirus Response Act (FFCRA) presents the single
largest health coverage transition event since the first open
enrollment period of the Affordable Care Act. As a condition of
receiving a temporary 6.2 percentage point Federal Medical Assistance
Percentage (FMAP) increase under the FFCRA, States have been required
to maintain enrollment of nearly all Medicaid enrollees. This
continuous enrollment condition expired on March 31, 2023, and States
now have 12 months to initiate and 14 months to complete renewals for
all individuals enrolled in Medicaid, CHIP and the Basic Health
Program. Additionally, many other temporary authorities adopted by
States during the COVID-19 PHE will expire at the end of the PHE, and
States will be returning to regular operations across their programs.
The resumption of normal Medicaid operations is generally referred to
as ``unwinding'' and the 12-month period for States to initiate all
outstanding eligibility actions that were delayed because of the FFCRA
continuous enrollment condition is called the ``unwinding period.'' CMS
considered States' unwinding responsibilities when proposing the
effective dates for the proposals in this rule, but, as noted below, we
seek State feedback on whether our proposals strike the correct
balance.
As we contemplate the timing of a final rule, we are considering
adopting an effective date of 60 days following publication of the
final rule and separate compliance dates for various provisions, which
we note where relevant in our discussion of specific proposals in this
proposed rule. We seek comment on whether an effective date of 60 days
following publication would be appropriate when combined with later
dates for compliance for some provisions. We also seek comment on the
timeframe that would be most achievable and appropriate for compliance
with each proposed provision and whether the compliance date should
vary by provision.
B. Medical Care Advisory Committees (MCAC)
We obtained feedback during various public engagement activities
conducted with States and other interested parties, which supports
research findings that the beneficiary perspective and lived Medicaid
experience \17\ should be considered when making policy decisions
related to Medicaid programs.<SUP>18 19</SUP> A 2022 report from the
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HHS Assistant Secretary of Planning and Evaluation (ASPE) noted that
including people with lived experience in the policy-making process can
lead to a deeper understanding of the conditions affecting certain
populations, facilitate identification of possible solutions, and avoid
unintended consequences of potential policy or program changes that
could negatively impact the people the program aims to serve.\20\ We
have concluded that beneficiary perspectives need to be central to
operating a high-quality health coverage program that consistently
meets the needs of all its beneficiaries.
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\17\ Lived experience refers to ``representation and
understanding of an individual's human experiences, choices, and
options and how those factors influence one's perception of
knowledge'' based on one's own life. In this context, we refer to
people who have been enrolled in Medicaid currently or in the past.
Accessed at https://aspe.hhs.gov/lived-
experience#:~:text=In%20the%20context%20of%20ASPE%E2%80%99s%20researc
h%2C%20people%20with,programs%20that%20aim%20to%20address%20the%20iss
ue%20%28s%29.
\18\ Zhu JM, Rowland R, Gunn R, Gollust S, Grande DT. Engaging
Consumers in Medicaid Program Design: Strategies from the States.
Milbank Q. 2021 Mar;99(1):99-125. doi: 10.1111/1468-0009.12492. Epub
2020 Dec 15. PMID: 33320389; PMCID: PMC7984666. Accessed at <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984666/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984666/</a>.
\19\ Key Findings from the Medicaid MCO Learning Hub Discussion
Group Series and Roundtable--Focus on Member Engagement and the
Consumer Voice. NORC at the University of Chicago. Jan 2021.
Accessed at <a href="https://www.norc.org/PDFs/Medicaid%20Managed%20Care%20Organization%20Learning%20Hub/MMCOLearningHub_MemberEngagement.pdf">https://www.norc.org/PDFs/Medicaid%20Managed%20Care%20Organization%20Learning%20Hub/MMCOLearningHub_MemberEngagement.pdf</a>.
\20\ Syreeta Skelton-Wilson et al., ``Methods and Emerging
Strategies to Engage People with Lived Experience,'' Office of the
Assistant Secretary for Planning and Evaluation (ASPE), U.S.
Department of Health and Human Services, January 4, 2022, <a href="https://aspe.hhs.gov/reports/lived-experience-brief">https://aspe.hhs.gov/reports/lived-experience-brief</a>.
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However, effective community engagement is not as simple as
planning a meeting and requesting feedback. To create opportunities
that facilitate true engagement, it is important to understand and
honor strengths and assets that exist within communities; recognize and
solicit the inclusion of diverse voices; dedicate resources to ensuring
that engagement is done in culturally meaningful ways; ensure
timelines, planning processes, and resources that support equitable
participation; and follow up with communities to let them know how
their input was utilized. Ensuring optimal health outcomes for all
beneficiaries served by a program through the design, implementation,
and operationalization of policies and programs requires intentional
and continuous effort to engage people who have historically been
excluded from the process.
Section 1902(a)(4) of the Act is a longstanding statutory provision
that, as implemented in part in regulations currently codified at 42
CFR 431.12,\21\ requires States to have a Medical Care Advisory
Committee (MCAC) in place to advise the State Medicaid agency about
health and medical care services. Under section 1903(a)(7) of the Act,
expenditures made by the State agency to operate the MCAC are eligible
for Federal administrative match.
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\21\ The regulatory provision was originally established in 36
FR 3793 at 3870.
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The current MCAC regulations at Sec. 431.12 require States to
establish such a committee, and describe high-level requirements
related to the composition of the committee, the scope of topics to be
discussed, and the support the Committee can receive from the State in
its administration. Due to the lack of specificity in the current
regulations, these regulations have not been consistently implemented
across States. For example, there is no mention of how States should
approach meeting periodicity or meeting structure in ways that are
conducive to including a variety of Medicaid interested parties. There
is also no mention in the regulations about how States can build
accountability through transparency with their interested parties by
publicly sharing meeting dates, membership lists, and the outcomes of
these meetings. The regulations also limit the MCAC discussions to
topics about health and medical care services--which in turn limits the
benefits of using the MCAC as a vehicle that can provide States with
varied ideas, suggestions, and experiences on a range of issues
(medical and non-medical) related to the effective administration of
the Medicaid program.
As such, we have determined the requirements governing MCACs need
to be more robust to ensure all States are using these committees
optimally to realize a more effective and efficient Medicaid program
that is informed by the experiences of beneficiaries, their caretakers,
and other interested parties. The current regulations have been in
place without change for over 40 years.\22\ Over the last four decades,
we have learned that the current MCAC requirements are insufficient in
ensuring that the beneficiary perspective is meaningfully represented
on the MCAC. Recent research regarding soliciting input from
individuals with lived experience, including our recent discussions
with States about their MCAC, provide a unique opportunity to re-
examine the purpose of this committee and update the policies to
reflect four decades of program experience.
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\22\ 43 FR 45091 at 45189.
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In 2022, we gathered feedback from various public engagement
activities conducted with States, other interested parties, and
directly from a subset of State Medicaid agencies that described a wide
variation in how States are operating MCACs today. The feedback
suggested that some MCACs operate simply to meet the broad Federal
requirements. As discussed previously in this section, we have
discovered that our current regulations do not further the statutory
goal of meaningfully engaging Medicaid beneficiaries and other low-
income people in matters related to the operation of the Medicaid
program. Meaningful engagement can help develop relationships and
establish trust between the communities served and the Medicaid agency
to ensure States receive important information concerning how to best
provide health coverage to their beneficiary populations. The current
MCAC regulations establish the importance of broad feedback from
interested parties, but they lack the specificity that can ensure
States use MCACs in ways that facilitate that feedback.
The current regulation requires that MCACs must include Medicaid
beneficiaries as committee members. However, the regulations do not
mention or account for the reality that other interested parties can
stifle beneficiary contribution in a group setting. For example, when
there are a small number of beneficiary representatives in large
committees with providers, health plans, and professional advocates, it
can be uncomfortable and intimidating for beneficiaries to share their
perspective and experience. Based on these reasons, several States
already use beneficiary-only groups that feed into larger MCACs.
Improvements to the MCACs are critical to ensuring a robust and
accurate understanding of beneficiaries' challenges to health care
access. The current regulations value State Medicaid agencies having a
way to get feedback from interested parties on issues related to the
Medicaid program. However, the current regulations lack specificity
related to how MCACs can be used to benefit the Medicaid program more
expressly by more fully promoting the beneficiary voice. MCACs need to
provide a forum for beneficiaries and people with lived experience with
the Medicaid program to share their experiences and challenges with
accessing health care, and to assist States in understanding and better
addressing those challenges. These committees also represent unique
opportunities for States to include representation by members that
reflect the demographics of their Medicaid program to ensure that the
program is best serving the needs of all beneficiaries, but not all
States are utilizing that opportunity.
The proposed rule seeks to strike a balance that reflects how
States currently use advisory committees (such as MCACs or standalone
beneficiary groups). We know that some States approach these committees
as a way to meet a Federal requirement while other States are using
them in much more innovative ways. As a middle ground, the proposed
rule seeks to: (1) address the gaps in the current regulations
described previously in this section; and (2) establish requirements to
implement
[[Page 27964]]
more effective advisory committees. States would select members in a
way that reflects a wide range of Medicaid interested parties (covering
a diverse set of populations and interests relevant to the Medicaid
program), place a special emphasis on the inclusion of the beneficiary
perspective, and create a meeting environment where each voice is
empowered to participate equally.
The changes we propose in this rule are rooted in best practices
learned from experience and from current State examples of community
engagement that support getting the type of feedback and experiences
from beneficiaries, their caretakers, providers, and other interested
parties that can then be used to positively impact care delivered
through the Medicaid program.
Accordingly, the proposed rule includes changes that, if finalized,
would support the implementation of the principles of bi-directional
feedback, transparency, and accountability. We propose changes to the
features of the new committee that could most effectively ensure member
engagement, including the staff and logistical support that is required
for beneficiaries and individuals representing beneficiaries to
meaningfully participate in these committees. We also propose changes
to expand the scope of topics to be addressed by the committee, address
committee membership composition, prescribe the features of
administration of the committee, establish requirements of an annual
report, and underscore the importance of beneficiary engagement through
the addition of a related beneficiary-only group.
C. Home and Community-Based Services (HCBS)
While Medicaid programs are required to provide medically necessary
nursing facility services for most eligible individuals age 21 or
older, coverage for home and community-based services (HCBS) is a State
option.\23\ As a result of this ``institutional bias,'' Medicaid
reimbursement for LTSS was primarily spent on institutional care,
historically, with very little spending for HCBS.\24\ However, over the
past several decades, States have used several Medicaid
authorities,\25\ as well as CMS-funded grant programs,\26\ to develop a
broad range of HCBS to provide alternatives to institutionalization for
eligible Medicaid beneficiaries and to advance person-centered care.
Consistent with many beneficiaries' preferences for where they would
like to receive their care, HCBS have become a critical component of
the Medicaid program and are part of a larger framework of progress
toward community integration of older adults and people with
disabilities that spans efforts across the Federal government. In fact,
total Medicaid HCBS expenditures surpassed the long-standing benchmark
of 50 percent of LTSS expenditures in FY 2013 and has remained higher
than 50 percent since then, reaching 55.4 percent in FY 2017 and 58.6
percent in FY 2019.\27\ A total of 30 States spent at least 50 percent
of Medicaid LTSS expenditures on HCBS in FY 2019.
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\23\ Murray, Caitlin, Alena Tourtellotte, Debra Lipson, and
Andrea Wysocki. ``Medicaid Long Term Services and Supports Annual
Expenditures Report: Federal Fiscal Year 2019.''Chicago, IL:
Mathematica, December, 2021. Accessed at <a href="https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltssexpenditures2019.pdf">https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltssexpenditures2019.pdf</a>.
\24\ Centers for Medicare and Medicaid Services. November 2020.
Long-Term Services and Supports Rebalancing Toolkit. Accessed at
<a href="https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf">https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf</a>.
\25\ These authorities include Medicaid State plan personal care
services and Social Security Act (the Act) section 1915(c) waivers,
section 1915(i) State plan HCBS, section 1915(j) self-directed
personal assistant services, and section 1915(k) Community First
Choice. See <a href="https://www.medicaid.gov/medicaid/home-community-based-services/home-community-based-services-authorities/index.html">https://www.medicaid.gov/medicaid/home-community-based-services/home-community-based-services-authorities/index.html</a> for
more information on these authorities. Some States also use
demonstration authority under section 1115(a) of the Act to cover
and test home and community-based service strategies. See <a href="https://www.medicaid.gov/medicaid/section-1115-demonstrations/index.html">https://www.medicaid.gov/medicaid/section-1115-demonstrations/index.html</a> for
more information.
\26\ Federally funded grant programs include the Money Follows
the Person (MFP) demonstration program, which was initially
authorized by the Deficit Reduction Act of 2005 (Pub. L. 109-171).
The MFP program was recently extended under the Consolidated
Appropriations Act, 2021 (Pub. L. 116-260), which allowed new States
to join the demonstration and made statutory changes affecting MFP
participant eligibility criteria, allowing grantees to provide
community transition services under MFP earlier in an eligible
individual's inpatient stay.
\27\ Murray, Caitlin, Alena Tourtellotte, Debra Lipson, and
Andrea Wysocki. ``Medicaid Long Term Services and Supports Annual
Expenditures Report: Federal Fiscal Year 2019.'' Chicago, IL:
Mathematica, December 9, 2021. Accessed at <a href="https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltssexpenditures2019.pdf">https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltssexpenditures2019.pdf</a>.
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Furthermore, HCBS play an important role in States' efforts to
achieve compliance with the Americans with Disabilities Act (ADA) of
1990, section 504 of the Rehabilitation Act of 1973 (section 504),\28\
section 1557 of the Affordable Care Act, and the Supreme Court's
decision in Olmstead v. L.C.,\29\ in which the Court held that
unjustified segregation of persons with disabilities is a form of
unlawful discrimination under the ADA \30\ and States must ensure that
persons with disabilities are served in the most integrated setting
appropriate to their needs.\31\ Section 9817 of the American Rescue
Plan Act of 2021 (ARP) (Pub. L. 117-2) recently provided a historic
investment in Medicaid HCBS by providing qualifying States with a
temporary 10 percentage point increase to the FMAP for certain Medicaid
expenditures for HCBS that States must use to implement or supplement
the implementation of one or more activities to enhance, expand, or
strengthen HCBS under the Medicaid program.\32\
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\28\ HHS interprets section 504 and Title II of the ADA
similarly regarding the integration mandate and the Department of
Justice generally interprets the requirements under section 504
consistently with those under Title II of the ADA.
\29\ 527 U.S. 581 (1999).
\30\ Medicaid and the Olmstead Decision. Accessed at <a href="https://www.medicaid.gov/about-us/program-history/medicaid-50th-anniversary/entry/47688">https://www.medicaid.gov/about-us/program-history/medicaid-50th-anniversary/entry/47688</a>.
\31\ Medicaid and the Olmstead Decision. Accessed at <a href="https://www.medicaid.gov/about-us/program-history/medicaid-50th-anniversary/entry/47688">https://www.medicaid.gov/about-us/program-history/medicaid-50th-anniversary/entry/47688</a>.
\32\ Information on State activities to expand, enhance, or
strengthen HCBS under ARP section 9817 can be found on <a href="http://Medicaid.gov">Medicaid.gov</a>
at <a href="https://www.medicaid.gov/medicaid/home-community-based-services/guidance/strengthening-and-investing-home-and-community-based-services-for-medicaid-beneficiaries-american-rescue-plan-act-of-2021-section-9817/index.html">https://www.medicaid.gov/medicaid/home-community-based-services/guidance/strengthening-and-investing-home-and-community-based-services-for-medicaid-beneficiaries-american-rescue-plan-act-of-2021-section-9817/index.html</a>.
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Medicaid coverage of HCBS varies by State and can include a
combination of medical and non-medical services, such as case
management, homemaker, personal care, adult day health, habilitation
(both day and residential), and respite care services. HCBS programs
serve a variety of targeted population groups, such as older adults,
and children and adults with intellectual or developmental
disabilities, physical disabilities, mental health/substance use
disorders, and complex medical needs. HCBS programs provide
opportunities for Medicaid beneficiaries to receive services in their
own homes and communities rather than in institutions.
CMS and States have worked for decades to support the increased
availability and provision of high-quality HCBS for Medicaid
beneficiaries. While there are quality and reporting requirements for
Medicaid HCBS, the requirements vary across authorities and are often
inadequate to provide the necessary information for ensuring that HCBS
are provided in a high-quality manner that best protects the health and
welfare of beneficiaries. Consequently, quality measurement and
reporting expectations are not consistent across and within services,
but instead vary depending on the authorities under which States are
delivering services. Additionally, States have flexibility to determine
the quality measures they use in their HCBS programs. While we support
State flexibility, a lack of
[[Page 27965]]
standardization has resulted in thousands of metrics and measures
currently in use across States, with different metrics and measures
often used for different HCBS programs within the same State. As a
result, CMS and States are limited in the ability to compare HCBS
quality and outcomes within and across States or to compare the
performance of HCBS programs for different populations.
In addition, although there are differences in rates of disability
among demographic groups, there are very limited data currently
available to assess disparities in HCBS access, utilization, quality,
and outcomes. Few States have the data infrastructure to systematically
or routinely report data that could be used to assess whether
disparities exist in HCBS programs. This lack of available data also
prevents CMS and States from implementing interventions to make
improvements in HCBS programs designed to consistently meet the needs
of all beneficiaries.
Compounding these concerns have been notable and high-profile
instances of abuse and neglect in recent years, which have been shown
to result from poor quality care and inadequate oversight of HCBS in
Medicaid. For example, a 2018 report, ``Ensuring Beneficiary Health and
Safety in Group Homes Through State Implementation of Comprehensive
Compliance Oversight,'' \33\ (``Joint Report''), which was jointly
developed by the US Department of Health and Human Services'
Administration for Community Living (ACL), Office for Civil Rights
(OCR), and the Office of Inspector General (OIG), found systemic
problems with health and safety policies and procedures being followed
in group homes and that failure to comply with these policies and
procedures left beneficiaries in group homes at risk of serious harm.
In addition, while existing regulations provide safeguards for all
Medicaid beneficiaries in the event of a denial of Medicaid eligibility
or an adverse benefit determination by the State Medicaid agency and,
where applicable, by the beneficiary's managed care plan, there are no
safeguards related to other issues that HCBS beneficiaries may
experience, such as the failure of a provider to comply with the HCBS
settings requirements or difficulty accessing the services in the
person-centered service plan unless the individual is receiving those
services through a Medicaid managed care arrangement.
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\33\ Ensuring Beneficiary Health and Safety in Group Homes
Through State Implementation of Comprehensive Compliance Oversight.
US Department of Human Services, Office of the Inspector General,
Administration for Community Living, and Office for Civil Rights.
January 2018. Accessed at <a href="https://oig.hhs.gov/reports-and-publications/featured-topics/group-homes/group-homes-joint-report.pdf">https://oig.hhs.gov/reports-and-publications/featured-topics/group-homes/group-homes-joint-report.pdf</a>.
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Finally, through our regular interactions with State Medicaid
agencies, provider groups, and beneficiary advocates, we observed that
all these interested parties routinely cite a shortage of direct care
workers and high rates of turnover in direct care workers among the
greatest challenges in ensuring access to high-quality, cost-effective
HCBS for people with disabilities and older adults. Some States have
also indicated that a lack of direct care workers is preventing them
from transitioning individuals from institutions to home and community-
based settings. While workforce shortages have existed for years, they
have been exacerbated by the COVID-19 pandemic, which has resulted in
higher rates of direct care worker turnover (for instance, due to
higher rates of worker-reported stress), an inability of some direct
care workers to return to their positions prior to the pandemic (for
instance, due to difficulty accessing child care or concerns about
contracting COVID-19 for people with higher risk of severe illness),
workforce shortages across the health care sector, and wage increases
in types of retail and other jobs that tend to draw from the same pool
of workers.<SUP>34 35 36</SUP>
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\34\ MACPAC Issue Brief. State Efforts to Address Medicaid Home-
and Community-Based Services Workforce Shortages. March 2022.
Accessed at <a href="https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf">https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf</a>.
\35\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\36\ American Network of Community Options and Resources
(ANCOR). 2021. The state of America's direct support workforce 2021.
Alexandria, VA: ANCOR. Accessed at <a href="https://www.ancor.org/sites/default/files/the_state_of_americas_direct_support_workforce_crisis_2021.pdf">https://www.ancor.org/sites/default/files/the_state_of_americas_direct_support_workforce_crisis_2021.pdf</a>.
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To address the list of challenges outlined in this section, we are
proposing new Federal requirements in this proposed rule to improve
access to care, quality of care, and health and quality of life
outcomes; promote health equity for people receiving Medicaid-covered
HCBS; and ensure that there are safeguards in place for beneficiaries
who receive HCBS through FFS delivery systems. We seek comment on other
areas for rulemaking consideration. The proposed requirements are also
intended to promote public transparency related to the administration
of Medicaid HCBS programs.
D. Fee-for-Service (FFS) Payment
Section 1902(a)(30)(A) of the Act requires States to ``assure that
payments are consistent with efficiency, economy, and quality of care
and are sufficient to enlist enough providers so that care and services
are available under the plan at least to the extent that such care and
services are available to the general population in the geographic
area.'' Regulations at Sec. 447.203 require States to develop and
submit to CMS an access monitoring review plan (AMRP) for a core set of
services. Currently, the regulations rely on available State data to
support a determination that the State's payment rates are sufficient
to ensure access to care in Medicaid FFS that is at least as great for
beneficiaries as is generally available to the general population in
the geographic area, as required under section 1902(a)(30)(A) of the
Act.
In the May 6, 2011, Federal Register, we published the ``Medicaid
Program; Methods for Assuring Access to Covered Medicaid Services''
proposed rule (76 FR 26341; hereinafter ``2011 proposed rule''), which
outlined a data-driven process for States with Medicaid services paid
through a State plan under FFS to follow in order to document their
compliance with section 1902(a)(30)(A) of the Act. We finalized the
2011 proposed rule in the November 2, 2015, Federal Register when we
published the ``Medicaid Program; Methods for Assuring Access to
Covered Medicaid Services'' final rule with comment period (80 FR
67576; hereinafter ``2015 final rule with comment period''). Among
other requirements, the 2015 final rule with comment period required
States to develop and submit to CMS an AMRP for certain Medicaid
services that is updated at least every 3 years. Additionally, the rule
required that when States submit a SPA to reduce or restructure
provider payment rates, they must consider the data collected through
the AMRP and undertake a public process that solicits input on the
potential impact of the proposed reduction or restructuring of Medicaid
FFS payment rates on beneficiary access to care. We published the
``Medicaid Program; Deadline for Access Monitoring Review Plan
Submissions'' final rule in the April 12, 2016 Federal Register (81 FR
21479; hereinafter ``2016 final rule'') with a revised deadline for
States' AMRPs to be submitted to us.
Following enactment, numerous States have expressed concern
regarding the administrative burden associated with the 2015 final rule
with comment period requirements, especially those
[[Page 27966]]
States with high rates of beneficiary enrollment in managed care. In an
attempt to address some of the States' concerns regarding unnecessary
administrative burden, we issued a State Medicaid Director letter
(SMDL) on November 16, 2017 (SMDL #17-004), which clarified the
circumstances in which provider payment reductions or restructurings
would likely not result in diminished access to care, and therefore,
would not require additional analysis and monitoring procedures
described in the 2015 final rule with comment period.\37\ Subsequently,
in the March 23, 2018 Federal Register, we published the ``Medicaid
Program; Methods for Assuring Access to Covered Medicaid Services-
Exemptions for States With High Managed Care Penetration Rates and Rate
Reduction Threshold'' proposed rule (83 FR 12696; hereinafter ``2018
proposed rule''), which would have exempted States from requirements to
analyze certain data or monitor access when the vast majority of their
covered beneficiaries receive services through managed care plans. That
proposed rule, if it had been finalized, would have provided similar
flexibility to all States when they make nominal rate reductions or
restructurings to FFS payment rates. Based on the responses received
during the public comment period, we decided not to finalize the
proposed exemptions.
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\37\ State Medicaid Director Letter #17-0004 Re: Medicaid Access
to Care Implementation Guidance. Accessed at <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/smd17004.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/smd17004.pdf</a>
(November 2017).
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In the July 15, 2019 Federal Register, we published the ``Medicaid
Program; Methods for Assuring Access to Covered Medicaid Services-
Rescission'' proposed rule (84 FR 33722; hereinafter ``2019 proposed
rule'') to rescind the regulatory access requirements at Sec. Sec.
447.203(b) and 447.204, and concurrently issued a CMCS Informational
Bulletin \38\ stating the agency's intention to establish a new access
strategy. Based on the responses we received during the public comment
period, we decided not to finalize the 2019 proposed rule, and instead
continue our efforts and commitment to develop a data-driven strategy
to understand access to care in the Medicaid program.
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\38\ CMCS Informational Bulletin: Comprehensive Strategy for
Monitoring Access in Medicaid, Accessed at <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/CIB071119.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/CIB071119.pdf</a> (July 2019).
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States have continued to question whether the AMRP process is the
most effective or accurate reflection of access to care in a State's
Medicaid program, and requested we provide additional clarity on the
data necessary to support compliance with section 1902(a)(30)(A) of the
Act. In reviewing the information that States presented through the
AMRPs, we also have questioned whether the data and analysis
consistently address the primary access-related question posed by
section 1902(a)(30)(A) of the Act--namely, whether rates are sufficient
to ensure access to care at least as great as that enjoyed by the
general population in geographic areas. The unstandardized nature of
the AMRPs, which largely defer to States to determine appropriate data
measures to review and monitor when documenting access to care, have
made it difficult to assess whether any single State's analysis
demonstrates compliance with section 1902(a)(30)(A) of the Act.
While the AMRPs were intended to be a useful guide to States in the
overall process to monitor beneficiary access, they are generally
limited to access in FFS delivery systems and focus on targeted payment
rate changes rather than the availability of care more generally or
population health outcomes (which may be indicative of the population's
ability to access care). Moreover, the AMRP processes are largely
procedural in nature and not targeted to specific services for which
access may be of particular concern, requiring States to engage in
triennial reviews of access to care for certain broad categories of
Medicaid services--primary care services, physician specialist
services, behavioral health services, pre and post-natal obstetric
services, and home health services. Although the 2016 final rule
reasonably discussed that the selected service categories intended to
be indicators for available access in the overall Medicaid FFS system,
the categories do not easily translate to the services authorized under
section 1905(a) of the Act, granting States deference as to how broadly
or narrowly to apply the AMRP analysis to services within their
programs. For example, the category ``primary care services'' could
encompass several of the Medicaid service categories described within
section 1905(a) of the Act and, without clear guidance on which section
1905(a) services categories, qualified providers, or procedures we
intended States to include within the AMRP analyses. States were left
to make their own interpretations in analyzing access to care under the
2016 final rule.
Similarly, a number of the AMRP data elements, both required and
suggested within the 2016 final rule, may be overly broad, subject to
interpretation, or difficult to obtain. Specifically, under the 2016
final rule provisions, States are required to review: the extent to
which beneficiary needs are fully met; the availability of care through
enrolled providers to beneficiaries in each geographic area, by
provider type and site of service; changes in beneficiary utilization
of covered services in each geographic area; the characteristics of the
beneficiary population (including considerations for care, service and
payment variations for pediatric and adult populations and for
individuals with disabilities); and actual or estimated levels of
provider payment available from other payers, including other public
and private payers, by provider type and site of service. Though
service utilization and provider participation are relatively easy
measures to source and track using existing Medicaid program data, an
analysis of whether beneficiary needs are fully met is at least
somewhat subjective and could require States to engage in a survey
process to complete. Additionally, while most Medicaid services have
some level of equivalent payment data that can be compared to other
available public payer data, such as Medicare, private pay information
may be proprietary and difficult to obtain. Therefore, many States
struggled to meet the regulatory requirement comparing Medicaid program
rates to private payer rates because of their inability to obtain
private payer data.
Due to these issues, States produced varied AMRPs through the
triennial process that were, as a whole, difficult to interpret or to
use in assessing compliance with section 1902(a)(30)(A) of the Act. In
isolation, a State's specific AMRP most often presented data that could
be meaningful as a benchmark against changes within a State's Medicaid
program, but did not present a case for Medicaid access consistent with
the general population in geographic areas. Frequently, the data and
information within the AMRPs were presented without a formal
determination or attestation from the State that the information
presented established compliance with section 1902(a)(30)(A) of the
Act. Because the States' AMRPs generally varied to such a great degree,
there was also little to glean in making State-to-State comparisons of
performance on access measures, even for States with geographic and
demographic similarities.
Based on results of the triennial AMRPs, we were uncertain of how
to make use of the information presented within them other than to make
them publicly available. We published the
[[Page 27967]]
AMRPs on <a href="http://Medicaid.gov">Medicaid.gov</a> but had little engagement with States on the
content or results of the AMRPs since much of the information within
the plans could not meaningfully answer whether access in Medicaid
programs satisfied the requirements of section 1902(a)(30)(A) of the
Act. Additionally, we received little feedback from providers,
beneficiaries, or advocates on whether or how interested parties made
use of the triennial AMRPs. However, portions of the 2016 final rule
related to public awareness and feedback on changes to Medicaid payment
rates and the analysis that we received from individual States
proposing to make rate changes was of great benefit in determining
approvals of State payment change proposals. Specifically, the portion
of the AMRP process where States update their plans to describe data
and measures to serve as a baseline against which they monitor after
reducing or restructuring Medicaid payments allows States to document
consistency with section 1902(a)(30)(A) of the Act at the time of SPA
submission, usually as an assessment of how closely rates align with
Medicare rates, and to understand the impact of reductions through data
monitoring after SPA approval.
Under this proposed rule, we are proposing to balance elimination
of unnecessary Federal and State administrative burden with robust
implementation of the Federal and State shared obligation to ensure
that Medicaid payment rates are set at levels sufficient to ensure
access to care for beneficiaries consistent with section 1902(a)(30)(A)
of the Act. The provisions of this proposed rule, as discussed in more
detail later, would better achieve this balance through improved
transparency of Medicaid FFS payment rates, through publication of a
comparative payment rate analysis to Medicare and payment rate
disclosures, and through a more targeted and defined approach to
evaluating data and information when States propose to reduce or
restructure their Medicaid payment rates. Payment rate transparency is
a critical component of assessing compliance with section
1902(a)(30)(A) of the Act. In addition, payment rate transparency helps
to ensure that interested parties have basic information available to
them to understand Medicaid payment levels and the associated effects
of payment rates on access to care so that they may raise concerns to
State Medicaid agencies via the various forms of public processes
discussed within this proposed rule. Along with improved payment rate
transparency and disclosures as well as comparative payment rate
analyses, we are proposing a more efficient process for States to
undertake when submitting rate reduction or restructuring SPAs to CMS
for review. As we move toward aligning our Medicaid access to care
strategy across FFS and managed care delivery systems, we will consider
additional rulemaking to help ensure that Medicaid payment rate
information is appropriately transparent and rates are fully consistent
with broad access to care across delivery systems, so that interested
parties have a more complete understanding of Medicaid payment rate
levels and resulting access to care for beneficiaries.
II. Provisions of the Proposed Regulations
A. Medicaid Advisory Committee and Beneficiary Advisory Group (Sec.
431.12)
Current Sec. 431.12 requires States to have a MCAC to advise the
State Medicaid agency about health and medical care services. The
current regulations are intended to ensure that State Medicaid agencies
have a way to receive feedback from interested parties on issues
related to the Medicaid program. However, the current regulations lack
specificity related to how these committees can be used to ensure the
proper and efficient administration of the Medicaid program more
expressly by more fully promoting beneficiary perspectives.
Under the authority of section 1902(a)(4) of the Act, section
1902(a)(19) of the Act, and our general rulemaking authority in section
1102 of the Act, we propose to update Sec. 431.12 to replace the
current MCAC requirements with a committee framework designed to ensure
the proper and efficient administration of the Medicaid program and to
better ensure that care and services under the Medicaid program will be
provided in a manner consistent with the best interests of the
beneficiaries. If finalized, States would be required to establish and
operate the newly named Medicaid Advisory Committee (MAC) and a
Beneficiary Advisory Group (BAG). The MAC and its corresponding BAG
would serve as vehicles for bi-directional feedback between interested
parties and the State on matters related to the effective
administration of the Medicaid program. With this proposal, FFP, or
Federal match, for Medicaid administrative activities would remain
available to States for expenditures related to MAC and BAG activities
in the same manner as the former MCAC.
We propose to amend the title and paragraph (a) of Sec. 431.12 to
update the name of the existing MCAC to the MAC, and to add the
requirement for States to establish and operate a dedicated advisory
group comprised of Medicaid beneficiaries, the BAG. Our goal is that
the committee and its corresponding advisory group would advise the
State not only on issues related to health and medical services, as the
MCAC did, but also on matters related to policy development and to the
effective administration of the Medicaid program consistent with the
language of section1902(a)(4)(B) of the Act, which requires a State
plan to meaningfully engage Medicaid beneficiaries and other low-income
people in the administration of the plan. While the Medicaid program
covers medical services, the program is increasingly also covering
services designed to address beneficiaries' social determinants of
health and their health-related social needs more generally. Therefore,
having a discussion with the MAC about topics that are not directly
related to covered services may be necessary to ensure that
beneficiaries are able to meaningfully access these services. Expanding
the scope of the current committee is necessary to align the actions of
the committee with the expanding scope of the Medicaid program,
consistent with section 1902(a)(4)(B) of the Act, because the MAC
creates a formalized way for interested parties and beneficiary
representatives to provide feedback to the State about issues related
to the Medicaid program and the services it covers and to help ensure
that the program operates efficiently and as it was designed to
operate.
Every State will vary in the types of topics that would benefit
from the interested parties' feedback, so discretion on which topics
will be discussed with the MAC will be left to the State. Depending on
the priorities of the State in a given year, States may find it helpful
to bring to the MAC issues related to, for example, grievances,
consumer experience survey ratings, design of a new program, or other
like topics. Proposed mandates for these entities are described later
in this section under proposed paragraph (g). We further propose
conforming updates to paragraph (b) regarding the State plan
requirements, to reflect the proposed MAC and BAG and the expanded
mandate proposed in this proposed rule. The interested parties advisory
group, proposed and described in the FFS sections of this proposed
rule, to advise States on rate setting for certain HCBS
[[Page 27968]]
is not related to the MAC or BAG outlined here. We note in that section
that a State would be able utilize its MAC and BAG to provide
recommendations for payment rates, thereby satisfying the requirements
of that proposal. However, the MAC and BAG requirements proposed here,
if finalized, are wholly separate from the interested parties advisory
group, regardless of whether that proposal is finalized as well.
We propose to update paragraph (c) of Sec. 431.12 regarding
appointment of committee members to specify that the members of the MAC
and BAG must be appointed by the agency director or higher State
authority on a rotating, continuous basis. Under our proposals,
committee and advisory group members would serve a specific amount of
time, the length of which will be determined by each State and noted in
its bylaws. After a committee or advisory group member term has been
completed, the State will appoint a new member, thus ensuring that MAC
and BAG memberships rotate continuously. We propose the State be
required to make public its process and bylaws for recruitment and
appointment of members of the MAC and BAG and post the list of both
sets of members on the State's website. Under our proposal, the website
page where this information is located must be easily accessible by the
public. These updates align with how advisory committees similar to the
MAC and BAG are run, and the changes are designed to provide additional
details to support States' operation of the MAC and BAG. Further, these
updates facilitate transparency, improving the current regulations,
which do not mention nor promote transparency of information related
the MCAC with the public. We believe that transparency of information
can lead to enhanced accountability on the part of the State to making
its MAC and BAG as effective as possible.
Advisory committees and groups can be most effective when they
represent a wide range of perspectives and experiences. The current MAC
regulations only provide high level descriptions of types of members
that should be selected. Since we know that each State environment is
different, in the proposed rule, we continue to provide the State with
discretion on how large the MAC and BAG should be, but we outline in
more detail the types of categories of members that can best reflect
the needs of a Medicaid program. We believe that diversely populated
MACs and BAGs can provide States with access to a broad range of
perspectives, and importantly, beneficiaries' perspective, which can
positively impact the administration of the Medicaid program.
We encourage States to take into consideration, as part of their
member selection process, the demographics of the Medicaid population
in their State. Keeping diverse representation in mind as a goal for
the MAC membership can be a way for States to acknowledge that specific
populations and those receiving critically important services be
appropriately represented on the MAC. For example, in making the MAC
appointments, the State may want to balance the representation of the
MAC according to geographic areas of the State and the demographics of
the Medicaid program of the State. The State may want to consider
geographical diversity (for example, urban, rural, tribal) when making
its membership selections. The State could also consider demographic
representation of its membership by including members representing or
serving Medicaid beneficiaries the following categories: (1) children's
health care; (2) behavioral health services; (3) preventive care and
reproductive health services; (4) health or service issues pertaining
specifically to people over age 65; and (5) health or service issues
pertaining specifically to people with disabilities. By offering these
considerations, we seek to support States in their efforts to eliminate
differences in health care access and outcomes experienced by diverse
populations enrolled in Medicaid. Our aim is to support several of the
priorities for operationalizing health equity across CMS programs as
outlined in the CMS Framework for Health Equity (2022-2032) and the HHS
Equity Action Plan which is consistent with E.O. 13985 which calls for
advancing equity for underserved populations.
As we considered effective ways to better integrate the beneficiary
perspective into decisions related the Medicaid program, we also
recognized that a diverse and representative set of interested parties
should be reflected in the composition of each State's MAC. We propose
to amend paragraph (d) of Sec. 431.12 regarding committee membership
to account for both membership and composition, and to require the MAC
membership include members from the BAG, described later in this
section, who are currently or have been Medicaid beneficiaries, and
individuals with direct experience supporting Medicaid beneficiaries
(for example, family members or caregivers \39\ of those enrolled in
Medicaid); as well as advocacy groups; providers or administrators of
Medicaid services; representatives of managed care plans or State
health plan associations representing such managed care plans; and
representatives from other State agencies that serve Medicaid
beneficiaries. This proposal is consistent with the language of section
1902(a)(4)(B) of the Act, which requires a State plan to meaningfully
engage Medicaid beneficiaries and other low-income people in the
administration of the plan. The change we propose would support States
to set up MACs that align with section 1902(a)(4)(B) of the Act since
they would now have to select the membership composition to reflect the
community members who represent the interests of Medicaid
beneficiaries. The State also benefits from having a way to hear how
the Medicaid program can be responsive to its beneficiaries' and the
Medicaid community's needs.
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\39\ Caregivers can be paid or unpaid.
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Specifically, in paragraph (d)(1) of Sec. 431.12, we propose that
at least 25 percent of the MAC must be individuals with lived Medicaid
beneficiary experience from the BAG. This means that the BAG would be
comprised of people who: (1) are currently or have been Medicaid
beneficiaries and (2) individuals with direct experience supporting
Medicaid beneficiaries (family members or caregivers of those enrolled
in Medicaid). We selected 25 percent as a threshold to reflect the
importance of including the beneficiary perspective in the
administration of the Medicaid program and to ensure that the
beneficiary perspective has equitable representation in the feedback
provided by the MAC. We did not select a higher percentage because we
acknowledge that States will benefit from a MAC that includes
representation from a diverse set of interested parties who work in
areas related to Medicaid but are not beneficiaries, their family
members or their caregivers. We seek comment on the 25 percent
requirement.
As noted earlier, representation from the remaining committee
members would be left to the States' discretion. Rather than
prescribing specific percentages for each category, we only propose to
require representation from each category as part of the MAC. The
specific percentage of each of category (other than the BAG members)
relative to the whole committee can be determined by each State. This
approach would provide States with flexibility to determine how to best
represent the unique landscape of each State's Medicaid program. We
seek comment on what should be the minimum percentage requirement that
MAC members be current/past Medicaid
[[Page 27969]]
beneficiaries or individuals with direct experience supporting Medicaid
beneficiaries (such as family members or caregivers of those enrolled
in Medicaid).
States need to know how to deliver care to its beneficiaries. In
addition to hearing directly from beneficiaries, the State can gain
insights into how to effectively administer its program, from other
groups of the Medicaid community. Categorically, we propose in
paragraph (d)(2) that the rest of the MAC must include representation
from each category: (1) members of State or local consumer advocacy
groups or other community-based organizations that represent the
interests of, or provide direct service, to Medicaid beneficiaries; (2)
clinical providers or administrators who are familiar with the health
and social needs of Medicaid beneficiaries and with the resources
available and required for their care; (3) representatives from
participating Medicaid managed care plans or the State health plan
association representing such plans, as applicable; and (4)
representatives from other State agencies serving Medicaid
beneficiaries, as ex-officio members.
States are determining which types of providers to include under
the clinical providers or administrators category, we recommend they
consider a wide range of providers or administrators that are
experienced with the Medicaid program including, but not limited to:
(1) primary care providers (internal or family medicine physicians or
nurse practitioners or physician assistants that practice primary
care); (2) behavioral health providers (that is, mental health and
substance use disorder providers); (3) reproductive health service
providers, including maternal health providers; (4) pediatric
providers; (5) dental and oral health providers; (6) community health,
rural health clinic or Federally Qualified Health Center (FQHC)
administrators; (7) individuals providing long-term care services and
supports; and (8) direct care workers \40\ who can be individuals with
direct experience supporting Medicaid beneficiaries (such as family
members or caregivers). Direct care workers also include community
health workers who assist Medicaid beneficiaries in navigating access
to needed services and care managers, care coordinators, or service
coordinators who assist Medicaid beneficiaries with complex care needs.
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\40\ CMS defines direct care workers as: a registered nurse,
licensed practical nurse, nurse practitioner, or clinical nurse
specialist who provides nursing services to Medicaid-eligible
individuals receiving home and community-based services; (2) A
licensed or certified nursing assistant who provides such services
under the supervision of a registered nurse, licensed practical
nurse, nurse practitioner, or clinical nurse specialist; (3) A
direct support professional; (4) A personal care attendant; (5) A
home health aide; or (6) Other individuals who are paid to provide
services to address activities of daily living or instrumental
activities of daily living, behavioral supports, employment
supports, or other services to promote community integration
directly to Medicaid-eligible individuals receiving home and
community-based services.
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We have also identified health plans as an important contributor to
the MAC, but we acknowledge that not all States that have managed care
delivery systems. We know many Medicaid health plans administer similar
committees and thus allow for States to tailor health plan
representation based on its managed care market. For example, States
can fulfil this category with only one or with multiple plans operating
in the State. In addition, we also give States the flexibility to meet
the health plan representation requirements with either participating
Medicaid managed care plans or the State health plan association
representing such plans, as applicable.
The proposed language in paragraph (d)(2)(D) broadens the type of
representatives from other State agencies that are required to be on
the committee from the similar MCAC requirement. The current MCAC
regulation requires membership by ``the director of the public welfare
department or the public health department, whichever does not head the
Medicaid agency.'' By expanding the definition of external agency
representation to be broader than the welfare or public health
department, we would give States more flexibility in representing the
Medicaid program's interests based on States' unique circumstances and
organizational structure. States can work with sister State agencies to
determine who should participate in the MAC (for example, foster care
agency, mental health agency, department of public health). We also
propose that these representatives be part of the committee as ex-
officio members, not as full members of the MAC. While we believe it
will be essential to have these State-interested parties present for
program coordination and information-sharing, we believe the formal
representation of the MAC should be comprised of beneficiaries,
advocates, community organizations, and providers that serve Medicaid
beneficiaries.
We propose to replace paragraph (e) of Sec. 431.12; in paragraph
(e) to require that States create a BAG, a dedicated beneficiary
advisory group that will meet separately from the MAC. Currently, the
requirements governing MCACs require the presence of beneficiaries in
committee membership but do little to ensure their contributions are
considered or their voices heard. For example, current paragraph (e)
describes committee participation and requires the committee
``[further] the participation of beneficiary members in the agency
program.'' This requirement provides little guidance toward this goal
and creates an environment where a beneficiary may not feel comfortable
participating despite the opportunity being afforded in its technical
sense. We believe adding the creation of the BAG will result in
providing the State with increased access to the beneficiary
perspective. This proposal directly addresses and provides the
mechanism (the BAG) through which States can meet the language of
section 1902(a)(4)(B) of the Act, which requires a State plan to
meaningfully engage Medicaid beneficiaries and other low-income people
in the administration of the plan.
As such, the creation of a separate beneficiary-only advisory group
aligns with what we learned from multiple interviews with State
Medicaid agencies and other Medicaid interested parties (for example,
Medicaid researchers, former Medicaid officials) conducted over the
course of 2022 on the effective operation of the existing MCACs.
Interested parties described the importance of having a comfortable,
supportive, and trusting environment that facilitates beneficiaries'
ability to speak freely on matters most important to them. It is
equally important that the BAG have a subset of its members that also
sit on the State's MAC to ensure that the beneficiary perspective and
experience are heard directly. We noted earlier that some States may
already have highly effective BAG-type groups operating as part of
their Medicaid program. These groups may represent specific
constituencies such as children with complex medical needs or older
adults or may be participants in a specific waiver. In these instances,
States may utilize these groups to satisfy the proposed requirements of
this rule, provided the BAG-type group membership includes the MAC
members described in paragraph (d)(1). Those States must appoint
members from the BAG-type group to serve on the MAC to facilitate this
crossover.
Specifically, at paragraph (e)(1), we propose that the MAC members
described in proposed paragraph (d)(1) must also be members of the BAG.
This proposed requirement would facilitate the bi-directional
communication essential to effective beneficiary
[[Page 27970]]
engagement and allow for meaningful representation of diverse voices
across the MAC and BAG. In paragraph (e)(2), we propose that the BAG
meetings occur in advance of each MAC meeting to ensure BAG member
preparation for each MAC discussion. BAG meetings would also be subject
to requirements we propose in paragraph (f)(5), described later in this
section, that the BAG meetings must occur virtually, in-person, or
through a hybrid option to maximize member attendance. We plan to
expound on best practices for engaging beneficiary participation in
committees like the MAC in future guidance.
We propose at subsection (f) an administrative framework for the
MAC and BAG to ensure transparency and a meaningful feedback loop to
the public and among the members of the committee and group. Interested
parties' feedback and recent reports <SUP>41 42</SUP> published on
meaningful beneficiary engagement illuminate the need for more
transparent and standardized processes across States to drive
participation from key interested parties and to facilitate the
opportunity for participation from a diverse set of members and the
community. Further, we believe that in order for the State to comply
with the language of section 1902(a)(4)(B) of the Act, which requires a
State plan to meaningfully engage Medicaid beneficiaries and other low-
income people in the administration of the plan, it needs to be
responsive to the needs of its beneficiaries. To be responsive to the
needs of its beneficiaries, the State needs to be able to gather
feedback from a variety of people that touch the Medicaid program, and
the MAC and BAG will serve as the vehicle through which States can
obtain this feedback.
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\41\ Resources for Integrated Care and Community Catalyst,
``Listening to the Voices of Dually Eligible Beneficiaries:
Successful Member Advisory Councils'', 2019. Retrieved from <a href="https://www.resourcesforintegratedcare.com/listening_to_voices_of_dually_eligible_beneficiaries/">https://www.resourcesforintegratedcare.com/listening_to_voices_of_dually_eligible_beneficiaries/</a>.
\42\ Centers for Medicare & Medicaid Services.(n.d.). Person &
Family Engagement Strategy: Sharing with Our Partners. Retrieved
from: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-
and-Family-Engagement-Strategic-Plan-12-12-
16.pdf#:~:text=person%E2%80%99s%20priorities%2C%20goals%2C%20needs%20
and%20values.%E2%80%9D%20Using%20these,to%20guide%20all%20clinical%20
decisions%20and%20drives%20genuine.
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Specifically, in paragraph (f)(1), we propose to require State
agencies to develop and post publicly on their website bylaws for
governance of the MAC and BAG, current lists of MAC and BAG
memberships, and past meeting minutes for both the committee and group.
In paragraph (f)(2), we propose to require State agencies to develop
and post publicly a process for MAC and BAG member recruitment and
appointment, and for selection of MAC and BAG leadership. In paragraph
(f)(3), we propose to require State agencies to develop, publicly post,
and implement a regular meeting schedule for the MAC and BAG. The
requirement specifies the MAC and BAG must each meet at least once per
quarter and hold off-cycle meetings as needed. In paragraph (f)(4), we
propose that, at least two MAC meetings per year must be opened to the
public. For the MAC meetings that are open to the public, the meeting
agenda must include a dedicated time for public comment to be heard by
the MAC. Further, the State must also adequately notify the public of
the date, location, and time of these type (public) of MAC meetings at
least 30 calendar days in advance. None of the BAG meetings are not
required to be open to the public, unless the State's BAG members
decide otherwise. The same requirements would apply to States whose BAG
meetings were determined, by its membership, to be open to the public.
We seek comment on this approach.
In paragraph (f)(5), we propose to require that States offer in-
person and virtual attendance options to maximize member participation
at MAC and BAG meetings. We acknowledge that interested parties may
face a range of technological and internet accessibility limitations,
and that at a minimum, States will need to provide a telephone dial-in
option for MAC and BAG meetings. While we understand that in-person
interaction can sometimes assist in building trusted relationships, we
also recognize that accommodations for members and the public to
participate virtually is important, particularly since the beginning of
the COVID-19 pandemic. We invite comment on ways to best strike this
balance. We address technical and logistical challenges in paragraph
(f)(5) and address effective communication and language access and
meeting accessibility in subsequent paragraphs.
With respect to in-person meetings, we propose in paragraph (f)(6)
to require that States ensure meeting times and locations for MAC and
BAG meetings are selected to maximize participant attendance, which may
vary by meeting. For example, States may determine, by consulting with
its MAC and BAG members that holding meetings in various locations
throughout the State may result in better attendance. In addition, they
may ask the committee and group members about which times and weekdays
may be more favorable than others and hold meetings at those times
accordingly. States must also use the publicly posted meeting minutes,
which lists attendance by members, as a way to gauge which meeting
times and locations garner maximum participate attendance. Finally, in
paragraph (f)(7), we propose to require State agencies to facilitate
participation of beneficiaries by ensuring that meetings are accessible
to people with disabilities, that reasonable modifications are provided
when necessary to ensure access and enable meaningful participation,
that communication with individuals with disabilities is as effective
as with others, that reasonable steps are taken to provide meaningful
access to individuals with Limited English Proficiency, and that
meetings comply with the requirements at Sec. 435.905(b) and
applicable regulations implementing the ADA, section 504 of the
Rehabilitation Act, and section 1557 of the Affordable Care Act at 28
CFR part 35 and 45 CFR parts 84 and 92.
We propose to revise paragraph (g) to detail an expansion of the
topics on which the MAC and BAG should provide feedback to the Medicaid
agency from the prior MCAC requirements. In researching other States'
MACs, we know that some already use the MACs to get feedback from
interested parties, including beneficiaries, on a variety of topics
relating to the effective and efficient administration of the Medicaid
program. The changes we propose aim to strike a balance that reflects
some States' current practices without putting strict limitations on
specific topics for discussion to all States. Broadening the scope of
the topics that the MAC and BAG discuss will benefit the State by
giving greater insight into how it is currently delivering care for its
beneficiaries and thereby assist in identifying ways to improve the way
the Medicaid program is administered.
The State will use this engagement with the MAC and BAG to ensure
that the beneficiary and interested parties' voices are considered and
to allow the opportunity to adjust course based on the feedback
provided by the committee and group members. Topics of discussion are
to be based on State need and determined in collaboration with the MAC
to address matters related to policy development and matters related to
the effective administration of the Medicaid program. These topics
could include new policy or program developments; changes to services;
coordination of care and quality of
[[Page 27971]]
services; eligibility, enrollment, and renewal processes; the review of
communications to beneficiaries by the State Medicaid agency and
Medicaid managed care plans; the provision of culturally and
linguistically appropriate services, health equity, disparities, and
biases in the Medicaid program; and other issues that impact the
provision or outcomes of health and medical care services in the
Medicaid program as identified by the MAC, the BAG, or the State.
We propose new paragraph (h) to expand on existing State
responsibilities for managing the MAC and BAG regarding staff
assistance, participation, and financial support. We understand from
States and other interested parties, that many States already provide
staffing and financial support to their MACs in ways that meet or going
beyond what we propose through our updated requirements. We believe
that expanding upon the current standards regarding State
responsibility for planning and executing the functions of the MAC and
BAG will ensure consistent and ongoing standards to further
beneficiaries' and interested parties' engagement. For example, we know
that when any kind of interested parties group meets, all members of
that group need to fully understand the topics being discussed in order
to meaningfully engage in that discussion. This is particularly
relevant when the topics of discussion are complex or based in specific
terminology as Medicaid related issues often can be.
We believe that when States provide their MACs and BAGs with
additional staffing support that can explain, provide background
materials, and meet with the members in preparation for the larger
discussions, the members have a greater chance to provide more
meaningful feedback and ensure that members are adequately prepared to
engage in these discussions. The proposed changes to the requirements
seek to create environments that support meaningful engagement by the
members of these groups whose feedback can then be used by States to
support the efficient administration of their Medicaid program. We
anticipate providing additional guidance on model practices,
recruitment strategies, and ways to facilitate beneficiary
participation, and we invite comments on effective strategies to ensure
meaningful interested parties' engagement that in turn can facilitate
full beneficiary participation.
Under the current MCAC regulations in Sec. 431.12(f), each State
is required to provide the committee with staff assistance from the
agency, independent technical assistance as needed to enable it to make
effective recommendations, and financial arrangements, if necessary, to
make possible the participation of beneficiary members. The changes we
propose include adding requirements regarding recruitment, meeting
scheduling, recordkeeping, and support for beneficiary members. The
overlap with the current regulation would mean much of the work to
implement our proposals, if finalized, would already be occurring.
The proposed requirement for beneficiary support, including
financial support, is similar to current requirements, such as using
dedicated staff to support beneficiary attendance at both the MAC and
BAG meetings and providing financial assistance to facilitate meeting
attendance by beneficiary members, as needed. Staff may support
beneficiary attendance through outreach to the Medicaid beneficiary MAC
and BAG members throughout the membership period to provide information
and answer questions; identify barriers and supports needed to
facilitate attendance at MAC and BAG meetings; and facilitate access to
those supports. We are not proposing changes to existing financial
support requirements. However, we are proposing an additional
requirement that at least one member of the State agency's executive
staff attend all MAC and BAG meetings to provide an opportunity for
beneficiaries and representatives of the State's leadership to interact
directly.
In the spirit of transparency and to ensure compliance with the
updated regulations, we propose new paragraph (i) to require that the
MAC, with support from the State and in accordance with the
requirements proposed at this section, submit an annual report to the
State. The BAG perspective and feedback will be embedded in the report,
since the Group is represented on the MAC. The State, in turn, would be
required to review the report and include responses to recommendations
in the report. Prior to finalizing the report, the State must allow the
MAC to perform a final review. Once the MAC completes its final review,
the State must publish it by posting it on its website. The proposed
requirements of this section seek to both ensure transparency while
also facilitating a feedback loop and view into the impact of the
committee and group's recommendations. We invite comment on additional
ways to ensure that the State can create a feedback loop with the MAC
and BAG.
Finally, we propose no changes to, and thus maintain, the current
regulatory language on FFP from current paragraph (g) to support
committee and group administration, to appear in new paragraph (j) with
conforming edits for new committee and group names.
This requirement, if finalized, would be effective 60 days after
the effective date of the final rule, which would provide States with 1
year to implement these requirements. We seek comment on whether 1 year
is too much or not enough time for States to implement the updates in
this regulation in an effective manner. We understand that States may
need to modify their current MCACs to reflect the updated requirements
and may also need to create the BAG and recruit members to participate,
if they do not already have a similar entity already in place.
B. Home and Community-Based Services (HCBS)
We are proposing both to amend and add new Federal HCBS
requirements to improve access to care, quality of care, and
beneficiary health and quality of life outcomes, while consistently
meeting the needs of all beneficiaries receiving Medicaid-covered HCBS.
This preamble discusses our proposed changes in the context of current
law.
We have previously received questions from States with
demonstration projects under section 1115 of the Act that include HCBS
about the applicability of other HCBS regulatory requirements. As a
result, we are identifying that, consistent with the applicability of
other HCBS regulatory requirements to such demonstration projects, the
proposed requirements for section 1915(c) waiver programs and section
1915(i), (j), and (k) State plan services included in this proposed
rule, if finalized, would apply to such services included in approved
section 1115 demonstration projects, unless we explicitly waive one or
more of the requirements as part of the approval of the demonstration
project. We are not proposing to apply the requirements for section
1915(c) waiver programs and section 1915(i), (j), and (k) State plan
services in this proposed rule to the Program of All-Inclusive Care of
the Elderly (PACE) authorized under sections 1894 and 1934 of the Act,
as the existing requirements for PACE either already address or exceed
the requirements outlined in this proposed rule, or are substantially
different from those for section 1915(c) waiver programs and section
1915(i), (j), and (k) State plan services.
[[Page 27972]]
1. Person-Centered Service Plans (42 CFR 441.301(c), 441.450(c),
441.540(c), and 441.725(c))
Section 1915(c)(1) of the Act requires that services provided
through section 1915(c) waiver programs be provided under a written
plan of care (hereinafter referred to as ``person-centered service
plans'' or ``service plans''). Existing Federal regulations at Sec.
441.301(c) address the person-centered planning process and include a
requirement at Sec. 441.301(c)(3) that the person-centered service
plan be reviewed and revised, upon reassessment of functional need, at
least every 12 months, when the individual's circumstances or needs
change significantly, or at the request of the individual.
In 2014, we released guidance for section 1915(c) waiver programs
\43\ (hereinafter the ``2014 guidance'') that included expectations for
State reporting of State-developed performance measures to demonstrate
compliance with section 1915(c) of the Act and the implementing
regulations in part 441, subpart G, through six assurances, including
assurances related to person-centered service plans. The 2014 guidance
indicated that States should conduct systemic remediation and implement
a Quality Improvement Project when they score below an 86 percent
threshold on any of their performance measures. The six assurances
identified in the 2014 guidance were the following:
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\43\ Modifications to Quality Measures and Reporting in Sec.
1915(c) Home and Community-Based Waivers. March 2014. Accessed at
<a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/3-cmcs-quality-memo-narrative_0_2.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/3-cmcs-quality-memo-narrative_0_2.pdf</a>.
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1. Level of Care: The State demonstrates that it implements the
processes and instrument(s) specified in its approved waiver for
evaluating/reevaluating an applicant's/waiver participant's level of
care consistent with care provided in a hospital, nursing facility, or
Intermediate Care Facility for Individuals with Intellectual
Disabilities;
2. Service Plan: The State demonstrates it has designed and
implemented an effective system for reviewing the adequacy of service
plans for waiver participants;
3. Qualified Providers: The State demonstrates that it has designed
and implemented an adequate system for assuring that all waiver
services are provided by qualified providers;
4. Health and Welfare: The State demonstrates it has designed and
implemented an effective system for assuring waiver participant health
and welfare;
5. Financial Accountability: The State demonstrates that it has
designed and implemented an adequate system for insuring financial
accountability of the waiver program; and
6. Administrative Authority: The Medicaid Agency retains ultimate
administrative authority and responsibility for the operation of the
waiver program by exercising oversight of the performance of waiver
functions by other State and local/regional non-State agencies (if
appropriate) and contracted entities.\44\
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\44\ Performance measures were required for delegated functions
unless the delegated functions were covered by performance measures
associated with other assurances.
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We are proposing a different approach for States to demonstrate
that they meet the statutory requirements in section 1915(c) of the Act
and the regulatory requirements in part 441, subpart G, including the
requirements regarding assurances around service plans. The proposed
approach is based on feedback CMS obtained during various public
engagement activities conducted with States and other interested
parties over the past several years about the reporting discussed in
the 2014 guidance, as well as feedback received through the RFI \45\
discussed earlier about the need to standardize reporting and set
minimum standards for HCBS. Accordingly, the proposed HCBS requirements
in this rulemaking are intended to establish a new strategy for
oversight, monitoring, quality assurance, and quality improvement for
section 1915(c) waiver programs. The proposed approach focuses on
priority areas that have been identified by States, oversight entities,
consumer advocacy organizations, and other interested parties. The
priority areas are person-centered planning, health and welfare,
access, beneficiary protections, and quality improvement. As part of
this approach, we propose to establish new minimum performance
requirements and new reporting requirements for section 1915(c) waiver
programs that are intended to supersede and fully replace the reporting
requirements and the 86 percent performance level threshold for
performance measures described in the 2014 guidance. Further, to ensure
consistency and alignment across HCBS authorities, we propose to apply
the proposed requirements for section 1915(c) waiver programs to
section 1915(i), (j), and (k) State plan services as appropriate.
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\45\ CMS Request for Information: Access to Coverage and Care in
Medicaid & CHIP. February 2022. For a full list of question from the
RFI, see <a href="https://www.medicaid.gov/medicaid/access-care/downloads/access-rfi-2022-questions.pdf">https://www.medicaid.gov/medicaid/access-care/downloads/access-rfi-2022-questions.pdf</a>.
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Under section 1902(a)(19) of the Act, States must provide
safeguards to assure that eligibility for Medicaid-covered care and
services will be determined and provided in a manner that is consistent
with simplicity of administration and that is in the best interest of
Medicaid beneficiaries. While the needs of some individuals who receive
HCBS may be relatively stable over some time periods, individuals who
receive HCBS experience changes in their functional needs and
individual circumstances, such as the availability of natural supports
or a desire to choose a different provider, that necessitate revisions
to the person-centered service plan to remain as independent as
possible or to prevent adverse outcomes. The requirements to reassess
functional need and to update the person-centered service plan based on
the results of the reassessment, when circumstances or needs change
significantly, or at the request of the individual are important
safeguards that are in the best interest of beneficiaries because they
ensure that an individual's section 1915(c) waiver program services
change to meet the beneficiary's needs most appropriately as those
needs change. Section 2402(a) of the Affordable Care Act (Pub. L. 111-
148 and Pub. L. 111-152) requires the Secretary of HHS to ensure that
all States receiving Federal funds for HCBS, including Medicaid,
develop HCBS systems that are responsive to the needs and choices of
beneficiaries receiving HCBS, maximize independence and self-direction,
provide support and coordination to facilitate the participant's full
engagement in community-life, and achieve a more consistent and
coordinated approach to the administration of policies and procedures
across public programs providing HCBS.\46\ In particular, section
2402(a)(1) of the Affordable Care Act requires States to allocate
resources for services in a manner that is responsive to the changing
needs and choices of beneficiaries receiving HCBS and to provide
strategies for beneficiaries receiving such services to maximize their
independence, while section 2402(a)(2) of the Affordable Care Act
requires States to provide beneficiaries who need HCBS with the support
and coordination needed to design a plan based on individual
preferences and
[[Page 27973]]
personal goals that support their full engagement in community life.
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\46\ Section 2402(a) of the Affordable Care Act--Guidance for
Implementing Standards for Person-Centered Planning and Self-
Direction in Home and Community-Based Services Programs. Accessed at
<a href="https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf">https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf</a>.
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Effective State implementation of the person-centered planning
process is integral to ensuring compliance with section 2402 of the
Affordable Care Act. This is because this process is how States
identify and document the service needs and choices of people receiving
HCBS, plan for delivering individualized services that promote
independence and self-direction, effectively coordinate services and
supports necessary for community living, and ensure that the services
and supports that people receive are responsive to their changing needs
and choices. Each component of the person-centered planning process,
including the functional assessment, developing and implementing the
person-centered service plan, and periodically reassessing and updating
of the service plan, are essential to ensuring States' compliance with
sections 2402(a)(1) and (2) of the Affordable Care Act.
Since the release of the 2014 guidance, we have received feedback
from States, the OIG, ACL, and OCR, and other interested parties on how
crucial person-centered planning is in the delivery of care and the
significance of the person-centered service plan for the assurance of
health and welfare for section 1915(c) waiver program participants. The
importance of the person-centered planning process to the assurance of
health and welfare is supported by the existing regulatory requirements
for section 1915(c) waivers, which indicate, at Sec.
441.301(c)(2)(vi), that person-centered service plans must ``reflect
risk factors and measures in place to minimize them, including
individualized back-up plans and strategies when needed'' and, at Sec.
441.301(c)(2)(xiii)(H), that person-centered service plans must
``include an assurance that interventions and supports will cause no
harm to the individual.'' As such, if States fail to conduct the
required reassessment and updating of the person-centered service plan,
they could increase the risk of harm for beneficiaries by not
identifying risk factors and measures to minimize them and by not
taking the steps necessary to assure that interventions and supports
will not cause harm.
To ensure a more consistent application of person-centered service
plan requirements across States and to protect the health and welfare
of section 1915(c) waiver participants, we propose under our authority
at sections 1915(c)(1) and 1902(a)(19) of the Act and section
2402(a)(1) and (2) of the Affordable Care Act, to codify a minimum
performance level to demonstrate that States meet the requirements at
Sec. 441.301(c)(3). Specifically, at new Sec. 441.301(c)(3)(ii)(A),
we propose to require that States demonstrate that a reassessment of
functional need was conducted at least annually for at least 90 percent
of individuals continuously enrolled in the waiver for at least 365
days. We also propose, at new Sec. 441.301(c)(3)(ii)(B), to require
that States demonstrate that they reviewed the person-centered service
plan and revised the plan as appropriate based on the results of the
required reassessment of functional need at least every 12 months for
at least 90 percent of individuals continuously enrolled in the waiver
for at least 365 days.
We considered whether to propose to codify the minimum 86 percent
performance level that was outlined in the 2014 guidance, instead of
the minimum 90 percent performance level we are now proposing. The
minimum 86 percent performance level was intended to provide States
with a reasonable threshold for demonstrating compliance with the
requirements at Sec. 441.301(c)(3). However, since we released the
2014 guidance, we have heard from many interested parties that a
minimum 86 percent performance level may not be sufficient to
demonstrate that a State is meeting these requirements. The key concern
expressed is that this performance level provides States with more
latitude than is necessary to account for unexpected delays in the
timeframe for conducting reassessments and updating service plans, as
States should assume that some delays are likely and account for them
as part of their reassessment and service planning processes. Further,
media and anecdotal reports indicate that re-assessment and care
planning processes are often delayed without valid reasons, which
suggests that beneficiaries may be at risk for preventable harm due to
unnecessary delays in person-centered planning processes and that we
should establish a more stringent threshold for States to demonstrate
compliance with the requirements at Sec. 441.301(c)(3). In response to
the feedback we have received since 2014, we are proposing a slight
increase to the minimum performance level outlined in the 2014
guidance. This proposed minimum performance level is intended to
strengthen person-centered planning requirements based on feedback we
have received, while also recognizing that there may be legitimate
reasons why assessment and care planning processes occasionally are not
completed timely in all instances.
We also considered whether to propose allowing good cause
exceptions to the minimum performance level in the event of a natural
disaster, public health emergency, or other event that would negatively
impact a State's ability to achieve a minimum 90 percent performance
level. In the end, we decided not to propose good cause exceptions
because the minimum 90 percent performance level is intended to account
for various scenarios that might impact a State's ability to achieve
these minimum performance levels. Further, there are existing disaster
authorities that States could utilize to request a waiver of these
requirements in the event of a public health emergency or a disaster.
We invite comment on these proposals.
At Sec. 441.301(c)(3), we are also proposing to move the sentence
beginning with ``The person-centered service plan must be reviewed . .
.'' to a new paragraph at Sec. 441.301(c)(3)(i) and to reposition the
regulatory text under the proposed title, Requirement. In addition, we
are proposing to revise the regulatory text at the renumbered
paragraph, which currently says, ``The person-centered service plan
must be reviewed, and revised upon reassessment of functional need as
required by Sec. 441.365(e), at least every 12 months, when the
individual's circumstances or needs change significantly, or at the
request of the individual'' to read, ``The State must ensure that the
person-centered service plan is reviewed, and revised, as appropriate,
based upon the reassessment of functional need as required by Sec.
441.365(e), at least every 12 months, when the individual's
circumstances or needs change significantly, or at the request of the
individual.'' We are proposing this revision to the regulatory text so
that it is clearer that the State is the required actor under Sec.
441.301(c)(3). We are also proposing this revision to the regulatory
text so that it is clear that changes to the person-centered service
plan are not required if the reassessment does not indicate a need for
changes. With this proposed revision to the regulatory text, a State
could, for instance, meet the requirement that the person-centered
service plan was reviewed and revised as appropriate based on the
results of the required reassessment of functional need by documenting
that there were no changes in functional needs or the individual's
circumstances upon reassessment that necessitated changes to the
service plan.
[[Page 27974]]
Section 2402(a)(3)(A) of the Affordable Care Act requires States to
improve coordination among, and the regulation of, all providers of
Federally and State-funded HCBS programs to achieve a more consistent
administration of policies and procedures across HCBS programs. In the
context of Medicaid coverage of HCBS, it should not matter whether the
services are covered directly on an FFS basis or by a managed care
entity to its enrollees. The requirement for ``consistent
administration'' should require consistency between these two modes of
service delivery. Accordingly, we are proposing to specify that a State
must ensure compliance with the requirements in Sec. 441.301(c)(3),
with respect to HCBS delivered under both FFS and managed care delivery
systems. To ensure consistency in person-centered service plan
requirements between FFS and managed care delivery systems, we propose
to add the requirements at Sec. 441.301(c)(3) to 42 CFR 438.208(c).
We also propose updates to existing language describing the person-
centered planning process specific to section 1915(c) waivers. Current
language describes the role of an individual's authorized
representative as if every waiver participant will require an
authorized representative, which is not the case and has been a source
of confusion for States and providers. We propose to remove extraneous
language from the regulation text at Sec. 441.301(c)(1) to now read:
``The individual, or if applicable, the individual and the individual's
authorized representative, will lead the person-centered planning
process. When the term `individual' is used throughout this section, it
includes the individual's authorized representative if applicable. In
addition, the person-centered planning process: . . .'' This proposed
language brings the section 1915(c) waiver regulatory text in line with
person-centered planning process language in both the section 1915(j)
and (k) State plan options.
We recognize that many States may need time to implement these
proposed requirements, including time to amend provider agreements or
managed care contracts, make State regulatory or policy changes,
implement process or procedural changes, update information systems for
data collection and reporting, or conduct other activities to implement
these requirements. As a result, we are proposing at Sec.
441.301(c)(3)(iii) to make the performance levels under Sec.
441.301(c)(3)(ii) effective 3 years after the effective date of Sec.
441.301(c)(3) (in other words, 3 years after the effective date of the
final rule) in FFS delivery systems. For States with managed care
delivery systems under the authority of sections 1915(a), 1915(b),
1932(a), or 1115(a) of the Act that include HCBS in the managed care
organization's (MCO), prepaid inpatient health plan's (PIHP), or
prepaid ambulatory health plan's (PAHP) contract, we are proposing to
provide States until the first managed care plan contract rating period
that begins on or after 3 years after the effective date of the final
rule to implement these requirements. This time period is based on
feedback from States and other interested parties that it could take 2
to 3 years to amend State regulations and work with their State
legislatures, if needed, as well as to revise policies, operational
processes, information systems, and contracts to support implementation
of the proposals outlined in this section. We also considered this
proposed timeframe based on all of the HCBS proposals outlined in this
proposed rule as whole. We invite comments on whether this timeframe is
sufficient, whether we should require a shorter timeframe (2 years) or
longer timeframe (4 years) to implement these provisions, and if an
alternate timeframe is recommended, the rationale for that alternate
timeframe. As noted previously, the proposed requirements at Sec.
441.301(c)(3), in combination with new proposed reporting requirements
at Sec. 441.311(b)(3) and other proposed requirements identified
throughout this proposed rule, are intended to supersede and fully
replace the reporting requirements and the required minimum 86 percent
performance level for performance measures described in the 2014
guidance. We expect that States may implement some of the requirements
proposed in this proposed rule in advance of the effective date. We
will work with States to phase-out the requirements in the 2014
guidance as they implement the future requirements that become part of
the final rule to reduce unnecessary burden and to avoid duplicative or
conflicting reporting requirements.
As discussed earlier in this section of the preamble, section
2402(a)(3)(A) of the Affordable Care Act requires States to improve
coordination among, and the regulation of, all providers of Federally
and State-funded HCBS programs to achieve a more consistent
administration of policies and procedures across HCBS programs. In
accordance with the requirement of section 2402(a)(3)(A) of the
Affordable Care Act for States to achieve a more consistent
administration of policies and procedures across HCBS programs and
because HCBS State plan options have similar person-centered planning
and service plan requirements, we are proposing to incorporate these
new requirements within the applicable HCBS regulatory sections.
Specifically, we propose to apply the proposed requirements at Sec.
441.301(c)(3) to section 1915(j), (k), and (i) State plan services by
cross-referencing at Sec. Sec. 441.450(c), 441.540(c), and 441.725(c),
respectively. Consistent with our proposal for section 1915(c) waivers,
we propose these requirements under section 1902(a)(19) of the Act,
which authorizes safeguards necessary to assure that eligibility for
care and services under the Medicaid program will be determined, and
such care and services will be provided, in a manner consistent with
the best interest of beneficiaries. We believe the same reasons for
proposing these requirements for section 1915(c) waivers are equally
applicable for these other HCBS authorities and are also responsive to
feedback we have received from States and interested parties over the
years requesting consistency of requirements across HCBS authorities.
We request comment on the application of these provisions to section
1915(i), (j), and (k) authorities.
Finally, we considered whether to also apply these proposed
requirements to section 1905(a) ``medical assistance'' State plan
personal care, home health, and case management services. However, we
are not proposing that these requirements apply to any section 1905(a)
State plan services at this time, based on State feedback that States
do not have the same data collection and reporting capabilities for
these services as they do for other HCBS at section 1915(c), (i), (j),
and (k), and because the person-centered planning and service plan
requirements for section 1905(a) services are substantially different
from those for section 1915(c), (i), (j), and (k) services.
Specifically, there are requirements for a ``comprehensive assessment
and periodic reassessment of individual needs'' and ``development (and
periodic revision) of a specific care plan based on the information
collected through the assessment'' under Sec. 440.169(d) for the
provision of case management services. There are also requirements for
a ``plan of treatment'' (or, at the option of the State, a ``service
plan'') under Sec. 440.167 for the provision of personal care
services. However, Sec. Sec. 440.169(d) and 440.167 do not include
specific timeframes that could be used to establish minimum
[[Page 27975]]
performance thresholds that would be similar to those proposed for
section 1915(c) waivers. A face-to-face encounter within the 90 days
before or within the 30 days after the start of the services is
required at Sec. 440.70(f)(1) for the initiation of home health
services, and a written plan of care that the ordering practitioner
reviews every 60 days for services is required under Sec. 440.70(a)(2)
for the provision of home health services. However, the proposed
minimum thresholds for section 1915(c) waiver services would be
incompatible with the required timeframes under Sec. 440.70(a)(2) and
(f)(1). Person-centered planning and service plan requirements are not
required by Medicaid for other section 1905(a) services, although we
recommend that States implement person-centered planning process for
all HCBS. We note that the vast majority of HCBS is delivered under
section 1915(c), (i), (j), and (k) authorities, while only a small
percentage of HCBS nationally is delivered under section 1905(a) State
plan authorities. However, the small overall percentage includes large
numbers of people with mental health needs who receive case management.
We request comment on whether we should establish similar person-
centered planning and service plan requirements for section 1905(a)
State plan personal care, home health, and case management services.
2. Grievance System (Sec. Sec. 441.301(c)(7), 441.464(d)(2)(v),
441.555(b)(2)(iv), and 441.745(a)(1)(iii))
As discussed earlier in section II.B.1., of this preamble, section
2402(a) of the Affordable Care Act requires the Secretary of HHS to
ensure that all States receiving Federal funds for HCBS, including
Medicaid HCBS, develop HCBS systems that are responsive to the needs
and choices of beneficiaries receiving HCBS, maximize independence and
self-direction, provide support and coordination to assist with a
community-supported life, and achieve a more consistent and coordinated
approach to the administration of policies and procedures across public
programs providing HCBS.\47\ Among other things, section
2402(a)(3)(B)(ii) of the Affordable Care Act requires development and
monitoring of an HCBS complaint system. Further, section 1902(a)(19) of
the Act requires States to provide safeguards to assure that
eligibility for Medicaid-covered care and services will be determined
and provided in a manner that is consistent with simplicity of
administration and the best interest of Medicaid beneficiaries.
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\47\ Section 2402(a) of the Affordable Care Act--Guidance for
Implementing Standards for Person-Centered Planning and Self-
Direction in Home and Community-Based Services Programs. Accessed at
<a href="https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf">https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf</a>.
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Federal regulations at 42 CFR part 431, subpart E require States to
provide Medicaid applicants and beneficiaries with an opportunity for a
fair hearing before the State Medicaid agency in certain circumstances,
including for a termination, suspension, or reduction of Medicaid
eligibility, or for a termination, suspension, or reduction in benefits
or services. These fair hearing rights apply to all Medicaid applicants
and beneficiaries, including those receiving HCBS regardless of the
delivery system. Under 42 CFR part 438, subpart F, Medicaid managed
care plans must have in place: an appeal system that allows a Medicaid
managed care enrollee to request an appeal, which is a review by the
Medicaid managed care plan of an adverse benefit determination issued
by the plan; and a grievance system, which allows a Medicaid managed
care enrollee to file an expression of dissatisfaction with the plan
about any matter other than an adverse benefit determination. Note that
if a Medicaid managed care enrollee exhausts the Medicaid managed care
plan's appeals process, the enrollee may request a fair hearing before
the State Medicaid agency. Medicaid managed care enrollees cannot
request a fair hearing for grievances because grievances are not
generally related to the direct provision of services. Section
1902(a)(3) of the Act provides for the opportunity for a State fair
hearing when a ``claim for medical assistance under the plan is denied
or is not acted upon with reasonable promptness.'' This structure
creates a disparity for FFS HCBS beneficiaries, as it does not provide
for a venue to raise concerns about issues that HCBS beneficiaries may
experience which are not subject to the fair hearing process, such as
the failure of a provider to comply with the HCBS settings requirements
at Sec. 441.301(c)(4) (note that these are issues for which a managed
care enrollee could file a grievance with their plan).
Under our authority at section 1902(a)(19) of the Act and section
2402(a)(3)(B)(ii) of the Affordable Care Act, we propose to require at
new Sec. 441.301(c)(7) that States establish grievance procedures for
Medicaid beneficiaries receiving section 1915(c) waiver program
services through an FFS delivery system. Specifically, we propose at
Sec. 441.301(c)(7) that States must establish a procedure under which
a beneficiary can file a grievance related to the State's or a
provider's compliance with the person-centered planning and service
plan requirements at Sec. Sec. 441.301(c)(1) through (3) and the HCBS
settings requirements at Sec. Sec. 441.301(c)(4) through (6). This
proposal is based on feedback obtained during various public engagement
activities conducted with interested parties over the past several
years about the need for beneficiary grievance processes in section
1915(c) waiver programs related to these requirements. However, to
avoid duplication with the grievance requirements at part 438, subpart
F, we are not proposing to apply this requirement to establish a
grievance procedure to managed care delivery systems. We note, though,
that the proposals in this section are similar to requirements for
managed care grievance requirements found at part 438, subpart F, with
any differences reflecting changes appropriate for FFS systems. The
proposed requirements included at Sec. 441.301(c)(7) in this proposed
rule are focused specifically on grievance systems and do not establish
new fair hearing system requirements, as appeals of adverse eligibility
and/or benefit or service determinations are addressed by existing fair
hearing requirements at 42 CFR part 431, subpart E. We welcome comments
on any additional changes we should consider in this section.
As discussed earlier in this section of the preamble, section
2402(a)(3)(B)(ii) of the Affordable Care Act requires development and
monitoring of an HCBS complaint system. In addition, section
2402(a)(3)(A) of the Affordable Care Act requires the Secretary of HHS
to ensure that all States receiving Federal funds for HCBS, including
Medicaid HCBS, develop HCBS systems that achieve a more consistent and
coordinated approach to the administration of policies and procedures
across public programs providing HCBS. As such, we believe the
requirement for States to establish grievance procedures for Medicaid
beneficiaries receiving section 1915(c) waiver program services through
a FFS delivery system are necessary to comply with the HCBS complaint
system requirements at section 2402(a)(3)(B)(ii) and to ensure
consistency in the administration of HCBS between managed care and FFS
delivery systems. Further, in the absence of a grievance system
requirement for FFS HCBS programs, States may not have established
processes and systems for people receiving section 1915(c) waiver
program services through FFS delivery
[[Page 27976]]
systems to express dissatisfaction with or voice concerns related to
States' compliance with the person-centered planning and service plan
requirements at Sec. 441.301(c)(1) through (3) and the HCBS settings
requirements at Sec. 441.301(c)(4) through (6), as such concerns are
not subject to the existing fair hearing process at 42 CFR part 431
subpart E. As a result, we believe the proposal for a grievance system
for FFS HCBS programs is necessary to assure that care and services
will be provided in a manner that is in the best interests of the
beneficiaries, as required by section 1902(a)(19) of the Act.
We have specifically focused this requirement on States' and
providers' compliance with the person-centered planning and service
plan requirements at Sec. 441.301(c)(1) through (3) and the HCBS
settings requirements at Sec. 441.301(c)(4) through (6) because of the
critical role that person-centered planning and the service plan play
in appropriate care delivery for people receiving HCBS. Additionally,
we have focused the grievance system requirements on the HCBS settings
requirements because of the importance of the HCBS settings
requirements to ensuring that HCBS beneficiaries have full access to
the benefits of community living and are able to receive services in
the most integrated setting appropriate to their needs. Beneficiary
advocates and other interested parties have also indicated to us that
these are especially important areas for which to ensure that grievance
processes are in place for all Medicaid beneficiaries receiving HCBS.
Further, focusing the grievance systems requirements on the person-
centered planning and service plan requirements at Sec. 441.301(c)(1)
through (3) and the HCBS settings requirements at Sec. 441.301(c)(4)
through (6) helps to ensure that the proposed grievance requirements do
not duplicate or conflict with existing fair hearing requirements at
part 431, subpart E, as HCBS settings requirements and person-centered
planning requirements are outside the scope of the fair hearing
requirements.
At Sec. 441.301(c)(7)(ii)(A), we propose to define ``grievance''
as an expression of dissatisfaction or complaint related to the State's
or a provider's compliance with the person-centered planning and
service plan requirements at Sec. 441.301(c)(1) through (3) and the
HCBS settings requirements at Sec. 441.301(c)(4) through (6),
regardless of whether the beneficiary requests that remedial action be
taken to address the area of dissatisfaction or complaint. At Sec.
441.301(a)(7)(ii)(B), we also propose to define ``grievance system'' as
the processes the State implements to handle grievances, as well as the
processes to collect and track information about them. To ensure
consistency in the administration of HCBS between managed care and FFS
delivery systems, we based these definitions on the definitions at part
438, subpart F.
At Sec. 441.301(c)(7)(iii)(A) through (C), we propose new general
requirements for States' grievance procedures. Specifically, at Sec.
441.301(c)(7)(iii)(A), we propose to require that a beneficiary or
authorized representative be permitted to file a grievance. Under the
proposal, another individual or entity may file a grievance on a
beneficiary's behalf, so long as the beneficiary or authorized
representative provides written consent. Our proposal would not permit
a provider to file a grievance that would violate conflict of interest
guidelines, which States are required to have in place under Sec.
441.540(a)(5). At Sec. 441.301(c)(7)(iii)(A), we also propose to
specify that all references to beneficiary in the regulatory text of
this section includes the beneficiary's representative, if applicable.
At Sec. 441.301(c)(7)(iii)(B)(1) through (7), we propose to
require States to:
<bullet> Have written policies and procedures for their grievance
processes that at a minimum meet the requirements of this proposed
section and serve as the basis for the State's grievance process;
<bullet> Provide beneficiaries with reasonable assistance in
completing the forms and procedural steps related to grievances and to
ensure that the grievance system is consistent with the availability
and accessibility requirements at Sec. 435.905(b);
<bullet> Ensure that punitive action is not threatened or taken
against an individual filing a grievance;
<bullet> Accept grievances, requests for expedited resolution of
grievances, and requests for extensions of timeframes from
beneficiaries;
<bullet> Provide beneficiaries with notices and other information
related to the grievance system, including information on their rights
under the grievance system and on how to file grievance, and ensure
that such information is accessible for individuals with disabilities
and individuals who are limited English proficient in accordance with
Sec. 435.905(b);
<bullet> Review grievance resolutions with which beneficiaries are
dissatisfied; and
<bullet> Provide information on the grievance system to providers
and subcontractors approved to deliver services under section 1915(c)
of the Act.
At Sec. 441.301(c)(7)(iii)(C)(1) through (5), we propose to
require that the processes for handling grievances must:
<bullet> Allow beneficiaries to file a grievance either orally or
in writing;
<bullet> Acknowledge receipt of each grievance;
<bullet> Ensure that decisions on grievances are not made by anyone
previously involved in review or decision-making related to the problem
or issue for which the beneficiary has filed a grievance or a
subordinate of such an individual, are made by individuals with
appropriate expertise, and are made by individuals who consider all of
the information submitted by the beneficiary related to the grievance;
<bullet> Provide beneficiaries with a reasonable opportunity, face-
to-face (including through the use of audio or video technology) and in
writing, to present evidence and testimony and make legal and factual
arguments related to their grievance;
<bullet> Provide beneficiaries, free of charge and in advance of
resolution timeframes, with their own case files and any new or
additional evidence used or generated by the State related to the
grievance; and
<bullet> Provide beneficiaries, free of charge, with language
services, including written translation and interpreter services in
accordance with 435.905(b), to support their participation in grievance
processes and their use of the grievance system.
At Sec. 441.301(c)(7)(iv)(A), we propose to require that the
beneficiary be able to file a grievance at any time. At Sec.
441.301(c)(7)(iv)(B), we propose to require that beneficiaries be
permitted to request expedited resolution of a grievance, whenever
there is a substantial risk that resolution within standard timeframes
will adversely affect the beneficiary's health, safety, or welfare,
such as if, for example, a beneficiary cannot access personal care
services authorized in the person-centered service plan.
At Sec. 441.301(c)(7)(v), we propose resolution and notification
requirements for grievances. Specifically, at Sec.
441.301(c)(7)(v)(A), we propose to require that States resolve and
provide notice of resolution related to each grievance as quickly as
the beneficiary's health, safety, and welfare requires and within
State-established timeframes that do not exceed the standard and
expedited timeframes proposed in Sec. 441.301(c)(7)(v)(B). At Sec.
441.301(c)(7)(v)(B)(1), we propose to require that standard resolution
of a grievance and notice to affected parties must occur within 90
calendar days of receipt of the grievance. At
[[Page 27977]]
Sec. 441.301(c)(7)(v)(B)(2), we propose to require that expedited
resolution of a grievance and notice must occur within 14 calendar days
of receipt of the grievance.
At Sec. 441.301(c)(7)(v)(C), we propose that States be permitted
to extend the timeframes for the standard resolution and expedited
resolution of grievances by up to 14 calendar days if the beneficiary
requests the extension, or the State documents that there is need for
additional information and how the delay is in the beneficiary's
interest. At Sec. 441.301(c)(7)(v)(D), we propose to require that
States make reasonable efforts to give the beneficiary prompt oral
notice of the delay, give the beneficiary written notice, within 2
calendar days of determining a need for a delay but no later than the
timeframes in paragraph (c)(7)(v)(B), of the reason for the decision to
extend the timeframe, and resolve the grievance as expeditiously as the
beneficiary's health condition requires and no later than the date the
extension expires, if the State extends the timeframe for a standard
resolution or an expedited resolution.
We note that the proposed requirements at Sec.
441.301(c)(7)(iv)(B) that beneficiaries be permitted to request
expedited resolution of a grievance and at Sec. 441.301(c)(7)(v)(B)(2)
related to the timeframe for expedited resolution of a grievance and
notice differ from the current grievance system requirements for
Medicaid managed care plans at part 438, subpart F, which do not
include specific requirements for an expedited resolution of a
grievance. We invite comment on whether part 438, subpart F should be
amended to include the proposed requirements at Sec.
441.301(c)(7)(iv)(B) and at Sec. 441.301(c)(7)(v)(B)(2).
Proposed Sec. 441.301(c)(7)(vi) describes proposed requirements
related to the notice of resolution for beneficiaries. Specifically, at
Sec. 441.301(c)(7)(vi)(A), we propose to require that States establish
a method for written notice to beneficiaries and that the method meet
the availability and accessibility requirements at Sec. 435.905(b). At
Sec. 441.301(c)(7)(vi)(B), we propose to require that States make
reasonable efforts to provide oral notice of resolution for expedited
resolutions.
Proposed Sec. 441.301(c)(7)(vii) lists proposed recordkeeping
requirements related to grievances. Specifically, at Sec.
441.301(c)(7)(vii)(A), we propose to require that States maintain
records of grievances and review the information as part of their
ongoing monitoring procedures. At Sec. 441.301(c)(7)(vii)(B)(1)
through (6), we propose to require that the record of each grievance
must contain the following information at a minimum: a general
description of the reason for the grievance, the date received, the
date of each review or review meeting (if applicable), resolution and
date of the resolution of the grievance (if applicable), and the name
of the beneficiary for whom the grievance was filed. Further, at Sec.
441.301(c)(7)(vii)(C), we propose to require that grievance records be
accurately maintained and in a manner that would be available upon our
request.
We recognize that many States may need time to implement these
requirements, including to amend provider agreements, make State
regulatory or policy changes, implement process or procedural changes,
update information systems for data collection and reporting, or
conduct other activities to implement these requirements. However, we
also recognize that the absence of a grievance system in FFS HCBS
systems poses a substantial risk of harm to beneficiaries. As a result,
we are proposing at Sec. 441.301(c)(7)(viii) that the requirement at
Sec. 441.301(c)(7) be effective 2 years after the effective date of
the final rule. A 2-year time period after the effective date of the
final rule for States to implement these requirements reflects our
attempt to balance two competing challenges: (1) the fact that there is
a gap in existing regulations for FFS HCBS grievance processes related
to important HCBS beneficiary protection issues involving person-
centered planning and HCBS settings requirements; and (2) feedback from
States and other interested parties that it could take 1 to 2 years to
amend State regulations and work with their State legislatures, if
needed, as well as to revise policies, operational processes,
information systems, and contracts to support implementation of the
proposals outlined in this section. We also considered all of the HCBS
proposals outlined in this proposed rule as whole. We invite comments
on overall burden for States to meet the requirements of this section,
whether this timeframe is sufficient, whether we should require a
shorter timeframe (1 year to 18 months) or longer timeframe (3 to 4
years) to implement these provisions, and if an alternate timeframe is
recommended, the rationale for that alternate timeframe.
As discussed earlier in section II.B.1. of this preamble, section
2402(a)(3)(A) of the Affordable Care Act requires States to improve
coordination among, and the regulation of, all providers of Federally
and State-funded HCBS programs to achieve a more consistent
administration of policies and procedures across HCBS programs. In
accordance with the requirement of section 2402(a)(3)(A) of the
Affordable Care Act for States to achieve a more consistent
administration of policies and procedures across HCBS programs and
because HCBS State plan options also must comply with the HCBS Settings
Rule and with similar person-centered planning and service plan
requirements, we are proposing to incorporate these grievance
requirements within the applicable regulatory sections. Specifically,
we propose to apply these proposed requirements in Sec. 441.301(c)(7)
to sections 1915(j), (k), and (i) State plan services by cross-
referencing at Sec. Sec. 441.464(d)(2)(v), 441.555(b)(2)(iv), and
441.745(a)(1)(iii), respectively.
Consistent with our proposal for section 1915(c) waivers, we
propose to apply the proposed grievance requirements in Sec.
441.301(c)(7) to sections 1915(j), (k), and (i) State plan services
based on our authority under section 1902(a)(19) of the Act to assure
that there are safeguards for beneficiaries and our authority at
section 2402(a)(3)(B)(ii) of the Affordable Care Act to require a
complaint system for beneficiaries. We believe the same arguments for
proposing these requirements for section 1915(c) waivers are equally
applicable to these other HCBS authorities. We request comment on the
application of the grievance system provisions to section 1915(i), (j),
and (k) authorities. We note that in the language added to Sec.
441.464(d)(2)(v), we identify that the proposed grievance requirements
apply when self-directed personal assistance services authorized under
section 1915(j) include services under a section 1915(c) waiver
program. As described later in this section of this proposed rule, we
have not proposed to apply these requirements to section 1905(a)
services; section 1905(a) personal care services are the other service
authorized under section 1915(j) authorities to be self-directed.
[[Page 27978]]
We considered whether to also apply the proposed requirements to
section 1905(a) ``medical assistance'' State plan personal care, home
health, and case management services. However, we are not proposing
that these requirements apply to any section 1905(a) State plan
services because section 1905(a) services are not required to comply
with HCBS settings requirements and because the person-centered
planning and service plan requirements for most section 1905(a)
services are substantially different from those for section 1915(c),
(i), (j), and (k) services. Further, the vast majority of HCBS is
delivered under section 1915(c), (i), (j), and (k) authorities, while
only a small percentage of HCBS nationally is delivered under section
1905(a) State plan authorities. We request comment on whether we should
establish grievance requirements for section 1905(a) State plan
personal care, home health, and case management services.
3. Incident Management System (Sec. Sec. 441.302(a)(6), 441.464(e),
441.570(e), and 441.745(a)(1)(v))
Section 1902(a)(19) of the Act requires States to provide
safeguards as may be necessary to assure that eligibility for care and
services will be determined, and that ``such care and services will be
provided,'' in a manner consistent with simplicity of administration
and ``the best interests of the recipients.'' Section 1915(c)(2)(A) of
the Act and current Federal regulations at Sec. 441.302(a) require
that States have in place necessary safeguards to protect the health
and welfare of individuals receiving section 1915(c) waiver program
services. Further, as discussed previously in section II.B.1. of this
preamble, section 2402(a) of the Affordable Care Act requires the
Secretary of HHS to ensure that all States receiving Federal funds for
HCBS, including Medicaid, develop HCBS systems that are responsive to
the needs and choices of beneficiaries receiving HCBS, maximize
independence and self-direction, provide support and coordination to
assist with a community-supported life, and achieve a more consistent
and coordinated approach to the administration of policies and
procedures across public programs providing HCBS.\48\ Among other
things, section 2402(a)(3)(B)(ii) of the Affordable Care Act requires
development and oversight of a system to qualify and monitor providers.
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\48\ Section 2402(a) of the Affordable Care Act--Guidance for
Implementing Standards for Person-Centered Planning and Self-
Direction in Home and Community-Based Services Programs. Accessed at
<a href="https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf">https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf</a>.
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As noted earlier in section II.B.1. of this preamble we released
guidance for section 1915(c) waiver programs in 2014 which noted that
States should report on State-developed performance measures to
demonstrate that they meet six assurances, including a Health and
Welfare assurance for States to demonstrate that they have designed and
implemented an effective system for assuring waiver participant health
and welfare. Specifically, the 2014 guidance highlighted, related to
the Health and Welfare assurance, the following:
<bullet> The State demonstrates on an ongoing basis that it
identifies, addresses, and seeks to prevent instances of abuse,
neglect, exploitation, and unexplained death;
<bullet> The State demonstrates that an incident management system
is in place that effectively resolves incidents and prevents further
similar incidents to the extent possible;
<bullet> The State policies and procedures for the use or
prohibition of restrictive interventions (including restraints and
seclusion) are followed;
<bullet> The State establishes overall health care standards and
monitors those standards based on the responsibility of the service
provider as stated in the approved waiver.
Consistent with the expectations for other performance measures,
the 2014 guidance noted that States should conduct systemic remediation
and implement a Quality Improvement Project when they score below 86
percent on any of their Health and Welfare performance measures.
Despite States implementing these statutory and regulatory
requirements to protect the health and welfare of individuals receiving
section 1915(c) waiver program services, and States' adherence to
related subregulatory guidance, there have been notable and high-
profile instances of abuse and neglect in recent years that highlight
the risks associated with poor quality care and with inadequate
oversight of HCBS in Medicaid. For example, a 2018 report, ``Ensuring
Beneficiary Health and Safety in Group Homes Through State
Implementation of Comprehensive Compliance Oversight,'' \49\ (referred
to as the Joint Report, developed by ACL, OCR, and the OIG), found
systemic problems with health and safety policies and procedures being
followed in group homes and that failure to comply with these policies
and procedures left beneficiaries in group homes at risk of serious
harm.
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\49\ Ensuring Beneficiary Health and Safety in Group Homes
Through State Implementation of Comprehensive Compliance Oversight.
US Department of Human Services, Office of the Inspector General,
Administration for Community Living, and Office for Civil Rights.
January 2018. Accessed at <a href="https://oig.hhs.gov/reports-and-publications/featured-topics/group-homes/group-homes-joint-report.pdf">https://oig.hhs.gov/reports-and-publications/featured-topics/group-homes/group-homes-joint-report.pdf</a>.
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In addition, in 2016 and 2017, OIG released several reports on
their review of States' compliance with Federal and State requirements
regarding critical incident reporting and monitoring.
<SUP>50 51 52</SUP> OIG found that several States did not comply with
Federal waiver and State requirements for reporting and monitoring
critical incidents involving individuals receiving HCBS through
waivers. In particular, they reported that:
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\50\ HHS OIG. ``Connecticut did not comply with Federal and
State requirements for critical incidents involving developmentally
disabled Medicaid beneficiaries.'' May 2016. Accessed at <a href="https://oig.hhs.gov/oas/reports/region1/11400002.pdf">https://oig.hhs.gov/oas/reports/region1/11400002.pdf</a>.
\51\ HHS OIG. ``Massachusetts did not comply with Federal and
State requirements for critical incidents involving developmentally
disabled Medicaid beneficiaries.'' July 2016. Accessed at <a href="https://oig.hhs.gov/oas/reports/region1/11400008.pdf">https://oig.hhs.gov/oas/reports/region1/11400008.pdf</a>.
\52\ HHS OIG. ``Maine did not comply with Federal and State
requirements for critical incidents involving Medicaid beneficiaries
with developmental disabilities.'' August 2017. Accessed at <a href="https://oig.hhs.gov/oas/reports/region1/11600001.pdf">https://oig.hhs.gov/oas/reports/region1/11600001.pdf</a>.
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<bullet> Critical incidents were not reported correctly;
<bullet> Adequate training to identify appropriate action steps for
reported critical incidents or reports of abuse or neglect was not
provided to State staff;
<bullet> Appropriate data sets to trend and track critical
incidents were not accessible to State staff; and
<bullet> Critical incidents were not clearly defined, making it
difficult to identify potential abuse or neglect.
In 2016, we conducted three State audits based at least in part on
concerns regarding health and welfare and media coverage on abuse,
neglect, or exploitation issues.\53\ We found that these three States
had not been meeting their section 1915(c) waiver assurances, similar
to findings reported by the OIG. In two cases, for the incidents of
concern, tracking and trending of critical incidents were not present.
Further, in at least two of the States, staffing at appropriate levels
was identified as an issue.
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\53\ Presentation by CMS for Advancing States: Quality in the
HCBS Waiver--Health and Welfare. See: <a href="http://www.nasuad.org/sites/nasuad/files/Final%20Quality%20201.pdf">http://www.nasuad.org/sites/nasuad/files/Final%20Quality%20201.pdf</a>.
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In January 2018, the United States Government Accountability Office
(GAO) released a report on a study of 48 States that covered assisted
living services.\54\ The GAO found large
[[Page 27979]]
inconsistencies between States in their definition of a critical
incident and their system's ability to report, track, and collect
information on critical incidents that have occurred. States also
varied in their oversight methods as well as the type of information
they were reviewing as part of this oversight. The GAO recommended that
requiring States to report information on incidents (such as the type
and severity of incidents and the number of incidents) would strengthen
the effectiveness of State and Federal oversight.
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\54\ Government Accountability Office. ``Medicaid assisted
living services--improved Federal oversight of beneficiary health
and welfare is needed.'' January 2018. Accessed at <a href="https://www.gao.gov/assets/690/689302.pdf">https://www.gao.gov/assets/690/689302.pdf</a>.
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In July 2019, we issued a survey to States that operate section
1915(c) waivers, requesting information on their approach to
administering incident management systems. The goal of the survey was
to obtain a comprehensive understanding of how States organize their
incident management system to best respond to, resolve, monitor, and
prevent critical incidents in their waiver programs. The survey found
that:
<bullet> Definitions of critical incidents vary across States and,
in some cases, within States for different HCBS programs or
populations;
<bullet> Some States do not use standardized forms for reporting
incidents, thereby impeding the consistent collection of information on
critical incidents;
<bullet> Some States do not have electronic incident management
systems, and, among those that do, many use systems with outdated
electronic platforms that are not linked with other State systems,
leading to the systems operating in silos and the need to consolidate
information across disparate systems; and
<bullet> Many States cited the lack of communication within and
across State agencies, including with investigative agencies, as a
barrier to incident resolution.
Additionally, during various public engagement activities conducted
with interested parties over the past several years, we have heard that
ensuring access to HCBS requires that we must first ensure health and
safety systems are in place across all States, a theme underscored by
the Joint Report.
Based on these findings and reports, under the authorities at
sections 1902(a)(19) and 1915(c)(2)(A) of the Act and section
2402(a)(3)(B)(ii) of the Affordable Care Act, we propose a new
requirement at Sec. 441.302(a)(6) to require that States provide an
assurance that they operate and maintain an incident management system
that identifies, reports, triages, investigates, resolves, tracks, and
trends critical incidents. This proposal is intended to ensure
standardized requirements for States regarding incidents that harm or
place a beneficiary at risk of harm and is based on our experience
working with States as part of the section 1915(c) waiver program and
informed by the incident management survey described previously in this
section of the proposed rule. In the absence of an incident management
system, people receiving section 1915(c) waiver program services are at
risk of preventable or intentional harm. As such, we believe that such
a system to identify and address incidents of abuse, neglect,
exploitation, or other harm during the course of service delivery is in
the best interest of and necessary for protecting the health and
welfare of individuals receiving section 1915(c) waiver program
services.
At Sec. 441.302(a)(6)(i)(A) through (G), we propose new
requirements for States' incident management systems. Specifically, at
Sec. 441.302(a)(6)(i)(A), we propose to establish a minimum standard
definition of a critical incident to include, at a minimum, verbal,
physical, sexual, psychological, or emotional abuse; neglect;
exploitation including financial exploitation; misuse or unauthorized
use of restrictive interventions or seclusion; a medication error
resulting in a telephone call to or a consultation with a poison
control center, an emergency department visit, an urgent care visit, a
hospitalization, or death; or an unexplained or unanticipated death,
including but not limited to a death caused by abuse or neglect.
Currently, there is no standardized Federal definition for the type of
events or instances that States should consider a critical incident
that must be reported by a provider to the State and considered for an
investigation by the State to assess whether the incident was the
result of abuse, neglect, or exploitation, and whether it could have
been prevented. The proposed definition at Sec. 441.302(a)(6)(i)(A) is
based on internal analyses of data and information obtained through a
CMS survey of States' incident management systems, commonalities across
definitions, and common gaps in States' definitions of critical
incidents (for instance, that many States do not consider sexual
assault to be a critical incident). We request comment on whether there
are specific types of events or instances of serious harm to section
1915(c) waiver participants, such as identity theft or fraud, that
would not be captured by the proposed definition and that should be
included, and whether the inclusion of any specific types of events or
instances of harm in the proposed definition would lead to the
overidentification of critical incidents.
At Sec. 441.302(a)(6)(i)(B), we propose to require that States
have electronic critical incident systems that, at a minimum, enable
electronic collection, tracking (including of the status and resolution
of investigations), and trending of data on critical incidents. We
request comment on the burden associated with requiring States to have
electronic critical incident systems and whether there is specific
functionality, such as unique identifiers, that should be required or
encouraged for such systems. Although we are not proposing to require
States to do so, States are also encouraged to advance the
interoperable exchange of HCBS data and support quality improvement
activities by adopting standards in 45 CFR, part 170 and other relevant
standards identified in the Interoperability Standards Advisory
(ISA).\55\ We also remind States that enhanced FFP is available at a 90
percent FMAP for the design, development, or installation of
improvements of mechanized claims processing and information retrieval
systems, in accordance with applicable Federal requirements.\56\
Enhanced FFP at a 75 percent FMAP is also available for operations of
such systems, in accordance with applicable Federal requirements.\57\
However, we note that receipt of these enhanced funds is conditioned
upon States meeting a series of standards and conditions to ensure
investments are efficient and effective.\58\
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\55\ Relevant standards adopted by HHS and identified in the ISA
include the USCDI (<a href="https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi">https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi</a>), eLTSS (<a href="https://www.healthit.gov/isa/documenting-care-plans-person-centered-services">https://www.healthit.gov/isa/documenting-care-plans-person-centered-services</a>), and Functional
Assessment Standardized Items (<a href="https://www.healthit.gov/isa/representing-patient-functional-status-andor-disability">https://www.healthit.gov/isa/representing-patient-functional-status-andor-disability</a>).
\56\ See section 1903(a)(3)(A)(i) and Sec. 433.15(b)(3), 80 FR
75817-75843; <a href="https://www.medicaid.gov/state-resourcecenter/faq-medicaid-and-chip-affordable-care-act-implementation/downloads/affordable-care-act-faq-enhancedfunding-for-medicaid.pdf">https://www.medicaid.gov/state-resourcecenter/faq-medicaid-and-chip-affordable-care-act-implementation/downloads/affordable-care-act-faq-enhancedfunding-for-medicaid.pdf</a>; <a href="https://www.medicaid.gov/federal-policy-guidance/downloads/SMD16004.pdf">https://www.medicaid.gov/federal-policy-guidance/downloads/SMD16004.pdf</a>.
\57\ See section 1903(a)(3)(B) and Sec. 433.15(b)(4).
\58\ See Sec. 433.112 (b, 80 FR 75841; <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-C/part-433/subpart-C">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-C/part-433/subpart-C</a>.
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At Sec. 441.302(a)(6)(i)(C), we propose to require States to
require providers to report to States any critical incidents that occur
during the delivery of section 1915(c) waiver program services as
specified in a waiver participant's person-centered service plan, or
any critical incidents that are a result of the
[[Page 27980]]
failure to deliver authorized services. Based on the findings of the
Joint Report, as well as the OIG and GAO reports cited earlier,
settings in which residential habilitation and day habilitation
services are provided, and services provided in a beneficiary's private
home by a provider should be of particular focus. We believe that such
a requirement will help to specify provider expectations for reporting
critical incidents and to ensure that harm that occurs because of the
failure to deliver services will be appropriately identified as a
critical incident.
At Sec. 441.302(a)(6)(i)(D), we propose to require that States use
claims data, Medicaid Fraud Control Unit data, and data from other
State agencies such as Adult Protective Services or Child Protective
Services to the extent permissible under applicable State law to
identify critical incidents that are unreported by providers and occur
during the delivery of section 1915(c) waiver program services, or as a
result of the failure to deliver authorized services. We believe that
such data can play an important role in identifying serious instances
of harm to waiver program participants, which may be unreported by a
provider, such as a death that occurs as a result of choking of an
individual with a developmental disability residing in a group home, or
a burn that occurs because a provider failed to appropriately supervise
someone with dementia and that results in an emergency department
visit. We request comment on whether States should be required to use
these data sources to identify unreported critical instances, and
whether there are other specific data sources that States should be
required to use to identify unreported critical incidents.
At Sec. 441.302(a)(6)(i)(E), we propose to require that States
share information, consistent with the regulations in 42 CFR part 431,
subpart F, on the status and resolution of investigations. We expect
this data sharing could be accomplished through the use of information
sharing agreements, with other entities in the State responsible for
investigating critical incidents, if the State refers critical
incidents to other entities for investigation. We also propose, at
Sec. 441.302(a)(6)(i)(F), to require States to separately investigate
critical incidents if the investigative agency fails to report the
resolution of an investigation within State-specified timeframes. These
proposed requirements are intended to ensure that the failure to
effectively share information between State agencies or other entities
in the State responsible for investigating incidents does not impede a
State's ability to effectively identify, report, triage, investigate,
resolve, track, and trend critical incidents, particularly where there
could be evidence of serious harm or a pattern of harm to a section
1915(c) waiver program participant for which a provider is responsible.
As noted in section II.B.1. of this proposed rule, in 2014, we
released guidance for section 1915(c) waiver programs in which we
indicated that States should report on State-developed performance
measures across several domains, including to demonstrate that the
State designed and implemented an effective system for assuring waiver
participant health and welfare. Specifically, the 2014 guidance noted
that States should demonstrate: on an ongoing basis that they identify,
address, and seek to prevent instances of abuse, neglect, exploitation,
and unexplained death; that an incident management system is in place
that effectively resolves those incidents and prevents further similar
incidents to the extent possible; State policies and procedures for the
use or prohibition of restrictive interventions (including restraints
and seclusion) are followed; and overall health care standards are
established and monitored. The 2014 guidance also indicated that States
should conduct systemic remediation and implement a Quality Improvement
Project when they score below 86 percent on any of their performance
measures.
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. Under our
authority at section 1902(a)(6) of the Act, we propose to modernize the
health and welfare reporting by requiring all States to report on the
same Federally prescribed quality measures as opposed to the State-
developed measures, which naturally vary State by State. Specifically,
at new Sec. 441.302(a)(6)(i)(G), we propose to require that States
meet the reporting requirements at Sec. 441.311(b)(1) related to the
performance of their incident management systems. We discuss these
reporting requirements in our discussion of proposed Sec.
441.311(b)(1). Further, under our authority at sections 1915(c)(2)(A)
and 1902(a)(19) of the Act, we propose to codify a minimum performance
level to demonstrate that States meet the requirements at Sec.
441.302(a)(6). Specifically, at new Sec. 441.302(a)(6)(ii)(A) through
(C), we propose to require that States demonstrate that an
investigation was initiated, within State-specified timeframes, for no
less than 90 percent of critical incidents; an investigation was
completed and the resolution of the investigation was determined,
within State-specified timeframes, for no less than 90 percent of
critical incidents; and corrective action was completed, within State-
specified timeframes, for no less than 90 percent of critical incidents
that require corrective action.
While we expect States to meet State-specified timeframes for
initiating investigations, completing investigations and determining
resolution, and completing corrective action plans for all critical
incidents, we are proposing to establish a minimum 90 percent
performance level in each of these areas in recognition of the various
scenarios that may impact a State's ability to meet these timeframes
for each critical incident (for example, some critical incidents may
require more complex investigations than others, an illness may delay
the interview of an important witness to the incident).
We considered whether to codify the minimum 86 percent performance
level that was established in the 2014 guidance, instead of the minimum
90 percent performance level we have proposed. The minimum 86 percent
performance level was intended to provide States with a reasonable
threshold for demonstrating compliance with the requirements at Sec.
441.302(a)(6). However, we have conducted extensive oversight and
received significant feedback from external parties since we released
the 2014 guidance. Our findings from the oversight and feedback have
led us to conclude that the minimum 86 percent performance level may
not be sufficient to demonstrate a State is meeting these requirements
because it provides States with more latitude than is necessary to
account for unexpected delays in the timeframes for investigating and
addressing critical incidents. Further, findings from our 2016 audits
and 2019 survey, feedback from States, OIG, ACL, OCR, and other
interested parties, and media and anecdotal reports document the harm
that beneficiaries can experience when States fail to investigate and
address critical incidents and indicate that we should establish a more
stringent threshold for States to demonstrate compliance with the
requirements at Sec. 441.302(a)(6). As a result, we are proposing an
increase to the minimum performance level in the 2014 guidance. This
proposed minimum performance level is intended to
[[Page 27981]]
strengthen health and welfare reporting requirements based on feedback
and evidence we have received, while also recognizing that there may be
legitimate reasons for delays in investigating and addressing critical
incidents.
We also considered whether to propose allowing good cause
exceptions to the minimum performance level in the event of a natural
disaster, public health emergency, or other event that would negatively
impact a State's ability to achieve a minimum 90 percent performance
level. In the end, we are not proposing good cause exceptions because
the minimum 90 percent performance level is intended to account for
various scenarios that might impact a State's ability to achieve these
performance levels. Further, as noted earlier with the person-centered
service plan requirements in section II.B.1. of this preamble, there
are existing disaster authorities that States could utilize to request
a waiver of these requirements in the event of a public health
emergency or a disaster.
At Sec. 441.302(a)(6)(iii), we propose to apply these requirements
to services delivered under FFS or managed care delivery systems. As
discussed earlier in section II.B.1. of this preamble, section
2402(a)(3)(A) of the Affordable Care Act requires States to improve
coordination among, and the regulation of, all providers of Federally
and State-funded HCBS programs to achieve a more consistent
administration of policies and procedures across HCBS programs. In the
context of Medicaid coverage of HCBS, it should not matter whether the
services are covered directly on a FFS basis or by a managed care
entity to its enrollees. The requirement for ``consistent
administration'' should require consistency between these two modes of
service delivery. We accordingly are proposing to identify that a State
must ensure compliance with the requirements in Sec. 441.302(a)(6)
with respect to HCBS delivered both under FFS and managed care delivery
systems.
As noted throughout the HCBS proposals in this rule, we recognize
that many States may need time to implement these requirements,
including to amend provider agreements or managed care contracts, make
State regulatory or policy changes, implement process or procedural
changes, update information systems for data collection and reporting,
or conduct other activities to implement these requirements. As a
result, we are proposing at Sec. 441.302(a)(6)(iii) to provide States
with 3 years to implement these requirements in FFS delivery systems
following effective date of the final rule. For States with managed
care delivery systems under the authority of sections 1915(a), 1915(b),
1932(a), or 1115(a) of the Act and that include HCBS in the MCO's,
PIHP's, or PAHP's contract, we are proposing to provide States until
the first managed care plan contract rating period that begins on or
after 3 years after the effective date of the final rule to implement
these requirements. This time period is based on feedback from States
and other interested parties that it could take 2 to 3 years to amend
State regulations and work with their State legislatures, if needed, as
well as to revise policies, operational processes, information systems,
and contracts to support implementation of the proposals outlined in
this section. We also considered all of the HCBS proposals outlined in
proposed rule as whole. We invite comments on whether this timeframe is
sufficient, whether we should require a shorter timeframe (2 years) or
longer timeframe (4 years) to implement these provisions, and if an
alternate timeframe is recommended, the rationale for that alternate
timeframe.
Again, the proposed requirements at Sec. Sec. 441.302(a)(6)(iii)
and 441.311(b)(1), in combination with other proposed requirements
identified throughout this proposed rule, are intended to supersede and
fully replace the reporting expectations and the minimum 86 percent
performance level for State's performance measures described in the
2014 guidance. We expect that States may implement some of the
requirements proposed in this proposed rule in advance of the effective
date. To reduce unnecessary burden and to avoid duplicative or
conflicting reporting requirements, we will work with States to phase-
out the 2014 guidance as they implement these proposed requirements
should a final rule be adopted.
Additionally, as discussed earlier in section II.B.1. of this
preamble, section 2402(a)(3)(A) of the Affordable Care Act requires
States to improve coordination among, and the regulation of, all
providers of Federally and State-funded HCBS programs to achieve a more
consistent administration of policies and procedures across HCBS
programs. In accordance with the requirement of section 2402(a)(3)(A)
of the Affordable Care Act for States to achieve a more consistent
administration of policies and procedures across HCBS programs and
because of the importance of assuring health and welfare for other HCBS
State plan options, we are proposing to incorporate these incident
management requirements within the applicable regulatory sections.
Specifically, we propose to apply the proposed requirements Sec.
441.302(a)(6) to section 1915(j), (k), and (i) State plan services by
cross-referencing at Sec. Sec. 441.570(e), 441.464(e), and
441.745(a)(1)(v), respectively. Consistent with our proposal for
section 1915(c) waivers, we propose these requirements based on our
authority under section 1902(a)(19) of the Act to assure that there are
safeguards for beneficiaries. We believe the same arguments for
proposing these requirements for section 1915(c) waivers are equally
applicable for these other HCBS authorities. We request comment on the
application of these provisions across section 1915(i), (j), and (k)
authorities. To accommodate the addition of new language at Sec.
441.464(e) and (f) (discussed later in section II.B.5. of this proposed
rule), we are proposing to renumber existing Sec. 441.464(e) as Sec.
441.464(g) and existing Sec. 441.464(f) as Sec. 441.464(h).
Finally, we considered whether to also apply the proposed incident
management system and critical incident reporting and performance
threshold requirements to section 1905(a) ``medical assistance'' State
plan personal care, home health, and case management services. However,
we are not proposing that these requirements apply to any section
1905(a) State plan services based on State feedback that they do not
have the same data collection and reporting capabilities in place for
section 1905(a) services as they do for section 1915(c), (i), (j), and
(k) services. Further, the vast majority of HCBS is delivered under
section 1915(c), (i), (j), and (k) authorities, while only a small
percentage of HCBS nationally is delivered under section 1905(a) State
plan authorities. We request comment on whether we should establish
similar health and welfare requirements for section 1905(a) State plan
personal care, home health, and case management services.
4. Reporting (Sec. 441.302(h))
Proposed Sec. 441.311, described in section II.B.7. of this
proposed rule, establishes a new Reporting Requirements section. As
discussed earlier in section II.B.1. of this preamble, section
2402(a)(3)(A) of the Affordable Care Act requires HHS to promulgate
regulations to ensure that States develop HCBS systems that are
designed to improve coordination among, and the regulation of, all
providers of Federally and State-funded HCBS programs to achieve a more
consistent administration of policies and procedures across HCBS
programs.
[[Page 27982]]
In addition to supporting States with achieving a more consistent
administration of policies and procedures across HCBS programs in
accordance with the requirement of section 2402(a)(3)(A) of the
Affordable Care Act, we believe that standardizing reporting across
HCBS authorities will streamline and simplify reporting for providers,
improve States' and CMS's ability to assess HCBS quality and
performance, and better enable States to improve the quality of HCBS
programs through the availability of comparative data. Further, 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.
To avoid duplicative or conflicting reporting requirements at Sec.
441.302(h), we propose to amend Sec. 441.302(h) by removing the
following language: ``annually''; ``The information must be consistent
with a data collection plan designed by CMS and must address the
waiver's impact on -''; and by removing paragraphs (1) and (2) under
Sec. 441.302(h). Further, we propose to add ``, including the data and
information as required in Sec. 441.311'' at the end of the new
amended text, ``Assurance that the agency will provide CMS with
information on the waiver's impact.'' By making these changes, we are
consolidating reporting expectations in one new section at proposed
Sec. 441.311, described in section II.B.7. of this proposed rule,
under our authority at section 1902(a)(6) of the Act and section
2402(a)(3)(A) of the Affordable Care Act. As noted earlier in section
II.B.1. of this proposed rule, this reporting will supersede existing
reporting for section 1915(c) waivers and standardize reporting across
section 1915 HCBS authorities.
5. HCBS Payment Adequacy (Sec. Sec. 441.302(k), 441.464(f),
441.570(f), 441.745(a)(1)(vi))
Section 1902(a)(30)(A) of the Act requires State Medicaid programs
to ensure that payments to providers are consistent with efficiency,
economy, and quality of care and are sufficient to enlist enough
providers so that care and services are available to beneficiaries at
least to the extent as to the general population in the same geographic
area. Access to most HCBS generally requires hands-on and in-person
services to be delivered by direct care workers. Direct care workers
are referred to by various names, such as direct support professionals,
personal care attendants, and home health aides, within and across
States. They perform a variety of roles, including nursing services,
assistance with activities of daily living (such as mobility, personal
hygiene, eating) and instrumental activities of daily living (such as
cooking, grocery shopping, managing finances), behavioral supports,
employment supports, and other services to promote community
integration for older adults and people with disabilities. We discuss
the definition of direct care workers in more detail below in the
context of our proposed definition of direct care workers.
Direct care workers typically earn low wages and receive limited
benefits,<SUP>59 60 61</SUP> contributing to a shortage of direct care
workers and high rates of turnover in this workforce, which can limit
access to and impact the quality of HCBS. Workforce shortages can also
reduce the cost-effectiveness of services for State Medicaid agencies
that take into account the actual cost of delivering services when
determining Medicaid payment rates, such as by increasing the reliance
on overtime and temporary staff, which have higher hourly costs than
non-overtime wages paid to permanent staff. Further, an insufficient
supply of HCBS providers can prevent individuals from transitioning
from institutions to home and community-based settings and from
receiving HCBS that can prevent institutionalization. HCBS is, on
average, less costly than institutional services,<SUP>62 63</SUP> and
most older adults and people with disabilities strongly prefer to live
in the community. Accordingly, limits on the availability of HCBS
lessen the ability for State Medicaid programs to deliver LTSS in a
cost-effective, beneficiary friendly manner.
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\59\ MACPAC Issue Brief. State Efforts to Address Medicaid Home-
and Community-Based Services Workforce Shortages. March 2022.
Accessed at <a href="https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf">https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf</a>.
\60\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\61\ We recognize that there are workforce shortages that may
impact access to other Medicaid-covered services aside from HCBS. We
are focusing in this proposed rule on addressing workforce shortages
in HCBS and continue to assess the feasibility and potential impact
of other actions to address workforce shortages in other parts of
the health care sector.
\62\ Reaves, E.L., & Musumeci, M.B. December 15, 2015. Medicaid
and Long-Term Services and Supports: A Primer. Kaiser Family
Foundation. Accessed at <a href="https://www.kff.org/medicaid/report/medicaid-and-long-term-services-and-supports-a-primer/">https://www.kff.org/medicaid/report/medicaid-and-long-term-services-and-supports-a-primer/</a>.
\63\ Kim, M-Y, Weizenegger, E., & Wysocki, A. July 22, 2022.
Medicaid Beneficiaries Who Use Long-Term Services and Supports:
2019. Chicago, IL: Mathematica. Accessed at <a href="https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-user-brief-2019.pdf">https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-user-brief-2019.pdf</a>.
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Shortages of direct care workers and high rates of turnover also
reduce the quality of HCBS. For instance, workforce shortages can
prevent individuals from receiving needed services and, in turn, lead
to poorer outcomes for people who need HCBS. Insufficient staffing can
also make it difficult for providers to achieve quality standards.\64\
High rates of turnover can reduce quality of care,\65\ including
through the loss of experienced and qualified workers and by reducing
continuity of care people receiving HCBS,\66\ which is associated with
the reduced likelihood of improvement in function among people
receiving home health aide services.\67\
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\64\ American Network of Community Options and Resources
(ANCOR). 2021. The state of America's direct support workforce 2021.
Alexandria, VA: ANCOR. Accessed at <a href="https://www.ancor.org/sites/default/files/the_state_of_americas_direct_support_workforce_crisis_2021.pdf">https://www.ancor.org/sites/default/files/the_state_of_americas_direct_support_workforce_crisis_2021.pdf</a>.
\65\ Newcomer R, Kang T, Faucett J. Consumer-directed personal
care: comparing aged and non-aged adult recipient health-related
outcomes among those with paid family versus non-relative providers.
Home Health Care Serv Q. 2011;30(4):178-97.
\66\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\67\ Russell D, Rosati RJ, Peng TR, Barr[oacute]n Y,
Andreopoulos E . Continuity in the provider of home health aide
services and the likelihood of patient improvement in activities of
daily living. Home Health Care Manage Pract. 2013;25(1):6-12.
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While workforce shortages have existed for years, the COVID-19
pandemic has exacerbated the problem, leading to higher rates of direct
care worker turnover (for instance, due to higher rates of worker-
reported stress), an inability of some direct care workers to return to
their positions prior to the pandemic (for instance, due to difficulty
accessing child care or concerns about contracting COVID-19 for people
with higher risk of severe illness), workforce shortages across the
health care sector, and wage increases in retail and other jobs that
tend to draw from the same pool of workers as some
HCBS.<SUP>68 69 70</SUP>
[[Page 27983]]
Further, demand for direct care workers is expected to continue rising
due to the growing needs of the aging population, the changing ability
of aging caregivers to provide supports, a broader societal shift away
from institutional services and towards services that are integrated in
the community, and a decline in the number of younger workers available
to provide services.<SUP>71 72 73</SUP> As discussed previously in
section II.B.1. of this proposed rule, section 2402(a) of the
Affordable Care Act requires the Secretary of HHS to ensure that all
States receiving Federal funds for HCBS, including Medicaid, develop
HCBS systems that are responsive to the needs and choices of
beneficiaries receiving HCBS, maximize independence and self-direction,
provide coordination for and support each person's full engagement in
community life, and achieve a more consistent and coordinated approach
to the administration of policies and procedures across public programs
providing HCBS.\74\ In particular, section 2402(a)(1) of the Affordable
Care Act requires States to allocate resources for services in a manner
that is responsive to the changing needs and choices of beneficiaries
receiving HCBS, while section 2402(a)(3)(B)(iii) of the Affordable Care
Act requires States to oversee and monitor HCBS system functions to
assure a sufficient number of qualified direct care workers to provide
self-directed personal assistance services. To comply with sections
2402(a)(1) and 2402(a)(3)(B)(iii) of the Affordable Care Act, States
must have a sufficient direct care workforce to be able to deliver
services that are responsive to the changing needs and choices of
beneficiaries, and, specifically, a sufficient number of qualified
direct care workers to provide self-directed personal assistance
services.
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\68\ MACPAC Issue Brief. State Efforts to Address Medicaid Home-
and Community-Based Services Workforce Shortages. March 2022.
Accessed at <a href="https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf">https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf</a>.
\69\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\70\ American Network of Community Options and Resources
(ANCOR). 2021. The state of America's direct support workforce 2021.
Alexandria, VA: ANCOR. Accessed at <a href="https://www.ancor.org/sites/default/files/the_state_of_americas_direct_support_workforce_crisis_2021.pdf">https://www.ancor.org/sites/default/files/the_state_of_americas_direct_support_workforce_crisis_2021.pdf</a>.
\71\ MACPAC Issue Brief. State Efforts to Address Medicaid Home-
and Community-Based Services Workforce Shortages. March 2022.
Accessed at <a href="https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf">https://www.macpac.gov/wp-content/uploads/2022/03/MACPAC-brief-on-HCBS-workforce.pdf</a>.
\72\ Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales.
2021. Caring for the future: The power and potential of America's
direct care workforce. Bronx, NY: PHI <a href="http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf">http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf</a>.
\73\ Centers for Medicare and Medicaid Services. November 2020.
Long-Term Services and Supports Rebalancing Toolkit. Accessed at
<a href="https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf">https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf</a>.
\74\ Section 2402(a) of the Affordable Care Act--Guidance for
Implementing Standards for Person-Centered Planning and Self-
Direction in Home and Community-Based Services Programs. Accessed at
<a href="https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf">https://acl.gov/sites/default/files/news%202016-10/2402-a-Guidance.pdf</a>.
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Consistent with section 1902(a)(30)(A) of the Act and sections
2402(a)(1) and 2402(a)(3)(B)(iii) of the Affordable Care Act, we
propose to require that State Medicaid agencies demonstrate that
payment rates for certain HCBS authorized under section 1915(c) of the
Act are sufficient to ensure a sufficient direct care workforce
(defined and explained later in this section of the proposed rule) to
meet the needs of beneficiaries and provide access to services in
accordance with the amount, duration, and scope specified in the
person-centered service plan, as required under Sec. 441.301(c)(2). We
believe that this proposal supports the economy, efficiency, and
quality of HCBS authorized under section 1915(c) of the Act, by
ensuring that a sufficient portion of State FFS and managed care
payments for HCBS go directly to compensation of the direct care
workforce. While many States have already voluntarily established such
minimums for payments authorized under section 1915(c) of the Act,\75\
we believe a Federal standard would support ongoing access to, and
quality and efficiency of, HCBS.
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\75\ For instance, as part of their required activities to
enhance, expand, or strengthen HCBS under ARP section 9817, some
States have required that a minimum percentage of rate increases and
supplemental payments go to the direct care workforce. See <a href="https://www.medicaid.gov/medicaid/home-community-based-services/guidance/strengthening-and-investing-home-and-community-based-services-for-medicaid-beneficiaries-american-rescue-plan-act-of-2021-section-9817/index.html">https://www.medicaid.gov/medicaid/home-community-based-services/guidance/strengthening-and-investing-home-and-community-based-services-for-medicaid-beneficiaries-american-rescue-plan-act-of-2021-section-9817/index.html</a> for more information on ARP section 9817.
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This proposal is designed to affect the inextricable link between
sufficient payments being received by the direct care workforce and
access to and, ultimately, the quality of HCBS received by Medicaid
beneficiaries. We believe that this proposal would not only benefit
direct care workers but also individuals receiving Medicaid HCBS
because supporting and stabilizing the direct care workforce will
result in better qualified employees, lower turnover, and a higher
quality of care. The direct care workforce must be able to attract and
retain qualified workers in order for beneficiaries to access providers
of the services they have been assessed to need and for the direct care
workforce to be comprised of workers with the training, expertise, and
experience to meet the diverse and often complex HCBS needs of
individuals with disabilities and older adults. Without access to a
sufficient pool of direct care providers, individuals are forced to
forgo having their needs met or addressed by workers without sufficient
training, expertise, or experience to meet their unique needs, both of
which could lead to worsening health and quality of life outcomes, loss
of independence, and institutionalization.<SUP>76 77 78 79</SUP>
Further, we believe that ensuring adherence to a Federal standard of
the percentage of Medicaid payments going to direct care workers is a
concrete step in recruitment and retention efforts to stabilize this
workforce by enhancing salary competitiveness in the labor market. In
the absence of such requirements, we are unable to support and
stabilize the direct care workforce because we are unable to ensure
that the payments are used primarily and substantially to pay for care
and services provided by direct care workers. Therefore, at Sec.
441.302(k)(3)(i), we propose to require that at least 80 percent of all
Medicaid payments, including but not limited to base payments and
supplemental payments, with respect to the following services be spent
on compensation
[…truncated; see source link]Indexed from Federal Register on May 3, 2023.
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