Proposed Rule2022-00117
Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs
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
January 12, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule would revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This proposed rule would also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 8 (Wednesday, January 12, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Proposed Rules]
[Pages 1842-1960]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00117]
[[Page 1841]]
Vol. 87
Wednesday,
No. 8
January 12, 2022
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 422 and 423
Medicare Program; Contract Year 2023 Policy and Technical Changes to
the Medicare Advantage and Medicare Prescription Drug Benefit Programs;
Proposed Rule
Federal Register / Vol. 87 , No. 8 / Wednesday, January 12, 2022 /
Proposed Rules
[[Page 1842]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422 and 423
[CMS-4192-P]
RIN 0938-AU30
Medicare Program; Contract Year 2023 Policy and Technical Changes
to the Medicare Advantage and Medicare Prescription Drug Benefit
Programs
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would revise the Medicare Advantage (MA)
(Part C) program and Medicare Prescription Drug Benefit (Part D)
program regulations to implement changes related to marketing and
communications, past performance, Star Ratings, network adequacy,
medical loss ratio reporting, special requirements during disasters or
public emergencies, and pharmacy price concessions. This proposed rule
would also revise regulations related to dual eligible special needs
plans (D-SNPs), other special needs plans, and cost contract plans.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by March 7, 2022.
ADDRESSES: In commenting, please refer to file code CMS-4192-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="https://www.regulations.gov">https://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-4192-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
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-4192-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:
Marna Metcalf Akbar, (410) 786-8251, or Melissa Seeley, (212) 616-
2329--General Questions.
Jacqueline Ford, (410) 786-7767--Part C Issues.
<a href="/cdn-cgi/l/email-protection#1a4a7b686e597b747e5e496e7b68487b6e73747d695a79776934727269347d756c"><span class="__cf_email__" data-cfemail="f3a3928187b0929d97b7a0879281a192879a9d9480b3909e80dd9b9b80dd949c85">[email protected]</span></a>--Part C and D Star Ratings Issues.
Marna Metcalf-Akbar, (410) 786-8251--D-SNP Issues.
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="https://www.regulations.gov">https://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.
Acronyms
ACC Automated Criteria Check
ANOC Annual Notice of Change
ARB At-Risk Beneficiaries
BBA Bipartisan Budget Act
CAHPS Consumer Assessment of Healthcare Providers and Systems
CMS Centers for Medicare & Medicaid Services
COI Collection of Information
COVID-19 Coronavirus 2019 Disease
C-SNP Chronic Condition Special Needs Plan
DME Durable Medical Equipment
D-SNP Dual Eligible Special Needs Plan
EOC Evidence of Coverage
FFS Fee-for-Service
FIDE SNP Fully Integrated Dual Eligible Special Needs Plan
HEDIS Healthcare Effectiveness Data and Information Set
HHS Department of Health and Human Services
HIDE SNP Highly Integrated Dual Eligible Special Needs Plan
HOS Health Outcomes Survey
HPMS Health Plan Management System
HSD Health Service Delivery
ICR Information Collection Requirement
I-SNP Institutional Special Needs Plan
MA Medicare Advantage
MAC Medicare Administrative Contractor
MACPAC Medicaid and CHIP Payment and Access Commission
MA-PD Medicare Advantage Prescription Drug
MCO Managed Care Organization
MCMG Medicare Communications and Marketing Guidelines
MACPAC Medicaid and CHIP Payment and Access Commission
MedPAC Medicare Payment Advisory Commission
MIPPA Medicare Improvements for Patients and Providers Act
MLR Medical Loss Ratio
MMA Medicare Prescription Drug, Improvement, and Modernization Act
MMP Medicare-Medicaid Plan
MOC Model of Care
MOOP Maximum Out-of-Pocket
NAMBA National Average Monthly Bid Amount
NEMT Non-emergency Medical Transportation
NMM Network Management Module
OACT Office of the Actuary
OMB Office of Management and Budget
PACE Programs of All-Inclusive Care for the Elderly
PBP Plan Benefit Package
PDE Prescription Drug Event
PDP Prescription Drug Plan
PHE Public Health Emergency
PRA Paperwork Reduction Act
RFI Request for Information
RFA Regulatory Flexibilities Act
SAE Service Area Expansion
SB Summary of Benefits
SNP Special Needs Plan
SSA Social Security Administration
TPMO Third-Party Marketing Organization
I. Executive Summary
A. Purpose
Over 27 million individuals receive their Medicare benefits through
Medicare Advantage (MA or Part C), including plans that offer Medicare
Prescription Drug Benefit (Part D) coverage. Over 24 million
individuals receive Part D coverage through standalone Part D plans.
The primary purpose of this proposed rule is to implement changes to
the MA and Part D programs. The proposed provisions in this rule will
reduce out-of-pocket prescription drug costs; improve price
transparency and market competition under the Part D program;
strengthen consumer protections to ensure MA and Part D beneficiaries
have accurate and accessible information about their health plan
choices and benefits; strengthen CMS oversight of MA and Part D plans;
and improve the integration of Medicare and Medicaid programs for
individuals enrolled in dual eligible special needs plans (D-SNPs). The
proposed D-SNP provisions build on the Patient Protection and
Affordable Care Act of 2010 (Affordable Care Act) (Pub. L. 111-148),
the
[[Page 1843]]
Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115-123), CMS experience
administering the MA and Part D programs, and the experiences of
Medicare-Medicaid Plans (MMPs) to better align and integrate benefits
for dually eligible beneficiaries.
B. Summary of Major Provisions
1. Enrollee Participation in Plan Governance (Sec. 422.107)
Managed care plans derive significant value from engaging enrollees
in defining, designing, participating in, and assessing their care
systems.\1\ We are proposing to require that any MA organization
offering a D-SNP must establish one or more enrollee advisory
committees in each State to solicit direct input on enrollee
experiences. We also propose that the committee include a reasonably
representative sample of individuals enrolled in the D-SNP(s) and
solicit input on, among other topics, ways to improve access to covered
services, coordination of services, and health equity for underserved
populations. We believe that the establishment and maintenance of an
enrollee advisory committee is a valuable beneficiary protection to
ensure that enrollee feedback is heard by managed care plans and to
help identify and address barriers to high-quality, coordinated care
for dually eligible individuals.
---------------------------------------------------------------------------
\1\ Centers for Medicare & Medicaid Services. (n.d.). Person &
Family Engagement Strategy: Sharing with Our Partners. Retrieved
from <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-and-Family-Engagement-Strategy-Summary.pdf">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-and-Family-Engagement-Strategy-Summary.pdf</a>.
---------------------------------------------------------------------------
2. Standardizing Housing, Food Insecurity, and Transportation Questions
on Health Risk Assessments (Sec. 422.101)
Section 1859(f)(5)(A)(ii)(I) of Social Security Act (hereafter
known as the Act) requires each special needs plan (SNP) to conduct an
initial assessment and an annual reassessment of the individual's
physical, psychosocial, and functional needs. We codified this
requirement at Sec. 422.101(f)(1)(i) as part of the model of care
requirements for all MA SNPs. Certain social risk factors can lead to
unmet social needs that directly influence an individual's physical,
psychosocial, and functional status. Many dually eligible individuals
contend with multiple social risk factors such as homelessness, food
insecurity, lack of access to transportation, and low levels of health
literacy.\2\ Building on CMS's experience with other programs and model
tests, we propose to require that all SNPs include standardized
questions on housing stability, food security, and access to
transportation as part of their health risk assessments.
---------------------------------------------------------------------------
\2\ Medicaid and CHIP Payment and Access Commission, ``Report to
Congress on Medicaid and CHIP,'' June 2020. Retrieved from: <a href="https://www.macpac.gov/wp-content/uploads/2020/06/June-2020-Report-to-Congress-on-Medicaid-and-CHIP.pdf">https://www.macpac.gov/wp-content/uploads/2020/06/June-2020-Report-to-Congress-on-Medicaid-and-CHIP.pdf</a>.
---------------------------------------------------------------------------
Our proposal would result in SNPs having a more complete picture of
the risk factors that may inhibit enrollees from accessing care and
achieving optimal health outcomes and independence. We believe this
knowledge would better equip the MA organizations offering these SNPs
to meet the needs of their members. Our proposal would also equip MA
organizations with person-level information that would help them better
connect people to covered services and social service organizations and
public programs that can help resolve housing instability, food
insecurity, or transportation challenges. Our proposal also would have
the benefit of standardizing these data elements collected through
HRAs, which we believe would eventually facilitate better data exchange
among SNPs (when an individual transitions from one SNP to another) as
well as facilitate the care management requirements under section
1859(f)(5) of the Act.
3. Refining Definitions for Fully Integrated and Highly Integrated D-
SNPs (Sec. Sec. 422.2 and 422.107)
Dually eligible individuals have an array of choices for how to
receive their Medicare coverage. We propose several changes to how we
define fully integrated dual eligible special needs plan (FIDE SNP) and
highly integrated dual eligible special needs plan (HIDE SNP) to help
differentiate various types of D-SNPs, clarify options for
beneficiaries, and improve integration.
We propose to require, for 2025 and subsequent years, that all FIDE
SNPs have exclusively aligned enrollment, as defined in Sec. 422.2,
and cover Medicaid home health, durable medical equipment, and
behavioral health services through a capitated contract with the State
Medicaid agency. We propose to require that each HIDE SNP's capitated
contract with the State apply to the entire service area for the D-SNP
for plan year 2025 and subsequent years. Consistent with existing
policy outlined in sub-regulatory guidance, we also propose to codify
specific limited benefit carve-outs for FIDE SNPs and HIDE SNPs.
We believe these proposals will create better experiences for
beneficiaries and move FIDE SNPs and HIDE SNPs toward greater
integration, which we believe is a purpose of the amendments to section
1859(f) of the Act regarding integration made by section 50311(b) of
the BBA of 2018.
4. Additional Opportunities for Integration Through State Medicaid
Agency Contracts (Sec. 422.107)
Section 164 of Medicare Improvements for Patients and Providers Act
of 2008 (MIPPA) (Pub. L. 110-275) amended section 1859(f) of the Act to
require that a D-SNP contract with the State Medicaid agency in each
State in which the D-SNP operates to provide benefits, or arrange for
the provision of Medicaid benefits, to which an individual is entitled.
States have used these contracts to better integrate care for dually
eligible individuals. We propose to codify new pathways through which
States can use these contracts to require that certain D-SNPs with
exclusively aligned enrollment (a) establish contracts that only
include one or more D-SNPs within a State, and (b) integrate materials
and notices for enrollees. Where States choose to use this opportunity,
it would help individuals better understand their coverage. Because
Star Ratings are assigned at the contract level, this proposal would
also provide the State and the public with greater transparency on the
quality ratings for the D-SNP(s), helping CMS and States better
identify disparities between dually eligible beneficiaries and other
beneficiaries and target interventions accordingly.
We also propose mechanisms to better coordinate State and CMS
monitoring and oversight of certain D-SNPs when a State has elected to
require these additional levels of integration, including granting
State access to certain CMS information systems. Collectively, our
proposals would improve Federal and State oversight of certain D-SNPs
(and their affiliated Medicaid managed care plans) through greater
information-sharing among government regulators.
5. Attainment of the Maximum Out-of-Pocket Limit (Sec. Sec. 422.100
and 422.101)
In order to ensure that MA plan benefits do not discriminate
against higher cost, less healthy enrollees, MA plans are required to
establish a limit on beneficiary cost-sharing for Medicare Part A and B
services after which the plan pays 100 percent of the service costs.
Current guidance allows MA plans, including D-SNPs, to not count
Medicaid-paid amounts or unpaid amounts toward this maximum out-of-
pocket (MOOP) limit, which results in
[[Page 1844]]
increased State payments of Medicare cost-sharing and disadvantages
providers serving dually eligible individuals in MA plans. We propose
to specify that the MOOP limit in an MA plan (after which the plan pays
100 percent of MA costs for Part A and Part B services) is calculated
based on the accrual of all cost-sharing in the plan benefit,
regardless of whether that cost sharing is paid by the beneficiary,
Medicaid, other secondary insurance, or remains unpaid because of State
limits on the amounts paid for Medicare cost-sharing and dually
eligible individuals' exemption from Medicare cost-sharing. The
proposal would result in more equitable payment for MA providers
serving dually eligible beneficiaries. We project that our proposal
would result in increased bid costs for the MOOP for some MA plans. A
portion of those higher bid costs would result in increased Medicare
spending of $3.9 billion over 10 years. That cost is partially offset
by lower Federal Medicaid spending of $2.7 billion and the portion of
Medicare spending paid by beneficiary Part B premiums, which totals
$600 million over 10 years. The net 10-year cost estimate for the
proposal is $614.8 million.
6. Special Requirements During a Disaster or Emergency (Sec.
422.100(m))
In order to ensure enrollees have uninterrupted access to care,
current regulations provide for special requirements at Sec.
422.100(m) for MA plans during disasters or emergencies, including
public health emergencies (PHEs), such as requirements for plans to
cover services provided by non-contracted providers and to waive
gatekeeper referral requirements. The timeframe during which these
special rules apply can be very limited depending on the type or scope
of the disaster or emergency, while other situations, like the current
PHE for COVID-19, may have an uncertain end date. Currently, the
regulation states that a disaster or emergency ends (thus ending the
obligation for MA plans to comply with the special requirements) the
earlier of when an end date is declared or when, if no end date was
identified in the declaration or by the official that declared the
disaster or emergency, 30 days have passed since the declaration. This
has caused some confusion among stakeholders, who are unsure whether to
continue special requirements during a state of disaster or emergency
after 30 days, or whether those special requirements do not apply after
the 30-day time period has elapsed. This proposal would clarify the
period of time during which MA organizations must comply with the
special requirements to ensure access for enrollees to covered services
throughout the disaster or emergency period, especially when the end
date is unclear and the period renews several times. We also propose to
codify an additional condition for triggering the special requirements
imposed by Sec. 422.100(m)(1), specifically that there is a disruption
in access to health care at the same time as the disaster or emergency.
7. Amend MA Network Adequacy Rules by Requiring a Compliant Network at
Application (Sec. 422.116)
We are proposing to amend Sec. 422.116 to require applicants to
demonstrate that they meet the network adequacy standards for the
pending service area as part of the MA application process for new and
expanding service areas and to adopt a time-limited 10-percentage point
credit toward meeting the applicable network adequacy standards for the
application evaluation. Under our current rules, we require that an
applicant attest that it has an adequate provider network that provides
enrollees with sufficient access to covered services, and we will not
deny an application based on the evaluation of the MA plan's network.
Network adequacy reviews are a critical component for confirming that
access to care is available for enrollees. As such, we believe that
requiring applicants to meet network adequacy standards as part of the
application process will strengthen our oversight of an organization's
ability to provide an adequate network of providers to deliver care to
MA enrollees. This change would also provide MA organizations with
information regarding their network adequacy ahead of bid submissions,
mitigating current issues with late changes to the bid that may affect
the bid pricing tool. Finally, we understand that it may be difficult
for applicants to have a full network in place almost one year ahead of
the beginning of the contract as the proposed change for network
adequacy rules would require. Therefore, the proposal includes a 10-
percentage point credit towards the percentage of beneficiaries
residing within published time and distance standards for new or
expanding service area applicants. Once the contract is operational,
the 10-percentage point credit would no longer apply and MA
organizations would need to meet full compliance.
8. Allow CMS To Calculate Star Ratings for Certain Measures for 2023
Given Impacts of the COVID-19 Public Health Emergency (Sec. 422.166)
Due to the scope and duration of the COVID-19 public health
emergency, we codified a change to the 2022 Star Ratings methodology in
the interim final rule titled ``Medicare and Medicaid Programs,
Clinical Laboratory Improvement Amendments (CLIA), and Patient
Protection and Affordable Care Act; Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' (CMS-
3401-IFC; 85 FR 54820), published in the Federal Register and effective
on September 2, 2020, which included a change to our extreme and
uncontrollable circumstances policy at 42 CFR 422.166(i)(11) to make it
possible for us to calculate 2022 Star Ratings for MA contracts. We
propose making a technical change at Sec. 422.166(i)(12) to enable CMS
to calculate 2023 Star Ratings for three Healthcare Effectiveness Data
and Information Set measures that are based on the Health Outcomes
Survey. Specifically, these measures are Monitoring Physical Activity,
Reducing the Risk of Falling, and Improving Bladder Control. Without
this technical change, CMS will be unable to calculate measure-level
2023 Star Ratings for these measures for any MA contract.
9. Past Performance Methodology To Better Hold Plans Accountable for
Violating CMS Rules (Sec. Sec. 422.502 and 422.503)
In the previous rulemaking cycle, CMS modified the past performance
methodology, revising the elements that are reviewed to determine if
CMS should permit an organization to enter into or expand an existing
contract. The current regulatory language prohibits an organization
from expanding or entering into a new contract if it has a negative net
worth or has been under sanction during the performance timeframe. We
are proposing to include an organization's record of Star Ratings,
bankruptcy issues, and compliance actions in our methodology going
forward.
10. Marketing and Communications Requirements on MA and Part D Plans To
Assist Their Enrollees (Sec. Sec. 422.2260 and 423.2260, 422.2267 and
423.2267, 422.2274 and 423.2274)
CMS has seen an increase in beneficiary complaints associated with
and has received feedback from beneficiary advocates and stakeholders
concerned about the marketing practices
[[Page 1845]]
of third-party marketing organizations (TPMOs) who sell multiple MA and
Part D products. In 2020, we received a total of 15,497 complaints
related to marketing. In 2021, excluding December, the total was
39,617. We are unable to say that every one of the complaints are a
result of TPMO marketing activities, but based on a targeted search, we
do know that many are related to TPMO marketing. In addition, we have
seen an increase in third party print and television ads, which appears
to be corroborated by state partners. Through rulemaking, we will
address the concerns with TPMOs by means of the following three
proposed updates to the communications and marketing requirements under
42 CFR parts 422 and 423, subpart V: (1) We propose to define TPMOs in
the regulation at Sec. Sec. 422.2260 and 423.2260 to remove any
ambiguity associated with MA plans/Part D sponsors responsibilities for
TPMO activities associated with the selling of MA and Part D plans, (2)
we propose to add a new disclaimer that would be required when TPMOs
market MA plans/Part D products (Sec. Sec. 422.2267(e) and
423.2267(e)), and (3) we propose an update to Sec. Sec. 422.2274 and
423.2274 to require additional plan oversight requirements associated
with TPMOs, in addition to what is already required under Sec. Sec.
422.504(i) and 423.505(i) if the TPMO is a first tier, downstream or
related entity (FDRs).
CMS' January 2021 final rule (86 FR 5864) did not require notice
and taglines, based on the HHS Office for Civil Rights repeal of
certain notice and tagline requirements associated with section 1557 of
the Patient Protection and Affordable Care Act of 2010 (Affordable Care
Act). In the months since the publication of this rule, CMS gained
additional insight regarding the void created by the lack of
notification requirements. Based on the significant population (12.2
percent) of those 65 and older who speak a language other than English
in the home and complaints CMS received through our Complaint Tracking
Module, we propose to require MA and Part D plans create a multi-
language insert that would inform the reader, in the top fifteen
languages used in the U.S., that interpreter services are available for
free. As a note, CMS provides plans a list of all languages that are
spoken by 5 percent or more of the population for every county in the
U.S. We propose to require the inclusion of the multi-language insert
whenever a Medicare beneficiary is provided a CMS required material
(for example, Evidence of Coverage, Annual Notice of Change, enrollment
form, Summary of Benefits) as defined under Sec. Sec. 422.2267(e) and
423.2267(e). Finally, we propose codifying a number of current sub-
regulatory communications and marketing requirements that were
inadvertently not included during the previous updates to 42 CFR parts
422 and 423, subpart V.
11. Greater Transparency in Medical Loss Ratio Reporting (Sec. Sec.
422.2460 and 423.2460)
To improve transparency and oversight concerning the use of Trust
Fund dollars, we are proposing to reinstate the detailed medical loss
ratio (MLR) reporting requirements that were in effect for contract
years 2014 to 2017, which required reporting of the underlying data
used to calculate and verify the MLR and any remittance amount, such as
incurred claims, total revenue, expenditures on quality improving
activities, non-claims costs, taxes, and regulatory fees. In addition,
we are proposing the collection of additional details regarding plan
expenditures so we can better assess the accuracy of MLR submissions,
the value of services being provided to enrollees under MA and Part D
plans, and the impacts of recent rule changes that removed limitations
on certain expenditures that count toward the 85 percent MLR
requirement.
12. Pharmacy Price Concessions to Drug Prices at the Point of Sale
(Sec. 423.100)
The ``negotiated prices'' of drugs, as the term is currently
defined in Sec. 423.100, must include all network pharmacy price
concessions except those contingent amounts that cannot ``reasonably be
determined'' at the point-of-sale. Under this exception, negotiated
prices typically do not reflect any performance-based pharmacy price
concessions that lower the price a sponsor ultimately pays for a drug,
based on the rationale that these amounts are contingent upon
performance measured over a period that extends beyond the point of
sale and thus cannot reasonably be determined at the point of sale.
We are proposing to eliminate this exception for contingent
pharmacy price concessions. We are proposing to delete the existing
definition of ``negotiated prices'' at Sec. 423.100 and to adopt a new
definition for the term ``negotiated price'' at Sec. 423.100, which we
are proposing to define as the lowest amount a pharmacy could receive
as reimbursement for a covered Part D drug under its contract with the
Part D plan sponsor or the sponsor's intermediary (that is, the amount
the pharmacy would receive net of the maximum negative adjustment that
could result from any contingent pharmacy payment arrangement and
before any additional contingent payment amounts, such as incentive
fees). To implement the proposed change at the point of sale, Part D
sponsors and their pharmacy benefit managers (PBMs) would load revised
drug pricing tables reflecting the lowest possible reimbursement into
their claims processing systems that interface with contracted
pharmacies. The proposed changes would take effect on January 1, 2023,
meaning, if finalized, Part D sponsors would need to account for the
changes in the bids that they submit for contract year 2023.
We are also proposing to add a definition of ``price concession''
at Sec. 423.100. Although ``price concession'' is a term important to
the adjudication of the Part D program, it has not yet been defined in
the Part D statute, Part D regulations, or sub-regulatory guidance. We
are proposing to define price concession in a broad manner to include
all forms of discounts and direct or indirect subsidies or rebates that
serve to reduce the costs incurred under Part D plans by Part D
sponsors.
C. Summary of Costs and Benefits
BILLING CODE 4120-01-P
[[Page 1846]]
[GRAPHIC] [TIFF OMITTED] TP12JA22.000
[[Page 1847]]
[GRAPHIC] [TIFF OMITTED] TP12JA22.001
[[Page 1848]]
[GRAPHIC] [TIFF OMITTED] TP12JA22.002
[[Page 1849]]
[GRAPHIC] [TIFF OMITTED] TP12JA22.003
BILLING CODE 4120-01-C
II. Provisions of the Proposed Rule
A. Improving Experiences for Dually Eligible Individuals
1. Overview and Background
Over 11 million people are concurrently enrolled in both Medicare
and Medicaid. Beneficiaries who are dually eligible for both Medicare
and Medicaid can face significant challenges in navigating the two
programs, which include separate or overlapping benefits and
administrative processes. Fragmentation between the two programs can
result in a lack of coordination for care delivery, potentially
resulting in: (1) Missed opportunities to provide appropriate, high-
quality care and improve health outcomes; and (2) undesirable outcomes,
such as avoidable hospitalizations and poor beneficiary experiences.
Advancing policies and programs that integrate care for dually eligible
individuals is one way in which we seek to address such
fragmentation.\3\
---------------------------------------------------------------------------
\3\ For example, see chapter 1 of Medicaid and CHIP Payment and
Access Commission, Report to Congress on Medicaid and CHIP, June
2021, and chapter 12 of Medicare Payment Advisory Committee, June
2019 Report to the Congress: Medicare and the Health Care Delivery
System.
---------------------------------------------------------------------------
``Integrated care'' refers to delivery system and financing
approaches that--
<bullet> Maximize person-centered coordination of Medicare and
Medicaid services, across primary, acute, long-term, behavioral, and
social domains;
<bullet> Mitigate cost-shifting incentives, including total-cost-
of-care accountability across Medicare and Medicaid; and
<bullet> Create seamless experiences for beneficiaries.
There is a range of approaches to integrating Medicare and Medicaid
benefits or financing for dually eligible individuals, including
through demonstrations and existing programs. The most prevalent forms
of integrated care use capitated financing, including capitation of
health plans to cover the full range of Medicare and Medicaid services.
Some States have carefully married MA dual eligible special needs plans
(D-SNPs) with Medicaid managed care organizations (MCOs) to create
integrated care programs for dually eligible individuals. Researchers
have generally found positive results from such integrated care
approaches. For example, a study in Minnesota showed that enrollees in
fully integrated Medicare-Medicaid managed care plans had greater
primary care physician use and lower inpatient hospital and emergency
department use in comparison to service delivery when Medicare and
Medicaid-funded services were delivered independently. The study also
found that home and community-based service use was greater for the
fully integrated Medicare-Medicaid managed care plans than the
comparison population and nursing
[[Page 1850]]
facility use was no greater.\4\ A study in Oregon found that dually
eligible individuals enrolled in plans with aligned financial
incentives for Medicare and Medicaid experienced more improvement in
their care relative to those enrolled in nonaligned Medicare Advantage
and Medicaid managed care plans.\5\ Other studies have found that
integrated care programs foster high beneficiary satisfaction,\6\
perform better than non-integrated plans on certain quality metrics,\7\
and provide benefit flexibility needed to allow beneficiaries to
continue living in the community.\8\ Overall, the number of dually
eligible individuals in integrated care or financing models or both has
increased over time, now exceeding 1 million beneficiaries, but it
remains the exception rather than the rule in most States.\9\
---------------------------------------------------------------------------
\4\ Anderson, W.L., Feng, Z., & Long, S.K. Minnesota Managed
Care Longitudinal Data Analysis, prepared for the U.S. Department of
Health and Human Services Assistant Secretary for Planning and
Evaluation (ASPE) (March 31, 2016). Retrieved from: <a href="https://aspe.hhs.gov/report/minnesota-managed-care-longitudinal-data-analysis">https://aspe.hhs.gov/report/minnesota-managed-care-longitudinal-data-analysis</a>.
\5\ Kim, H., Charlesworth, C.J., McConnell, K.J., Valentine,
J.B., and Grabowski, D.C. ``Comparing Care for Dual-Eligibles Across
Coverage Models: Empirical Evidence from Oregon'', Medical Care
Research and Review, (November 15, 2017) 1-17. Retrieved from:
<a href="https://journals.sagepub.com/doi/abs/10.1177/1077558717740206">https://journals.sagepub.com/doi/abs/10.1177/1077558717740206</a>.
\6\ Health Management Associates. Value Assessment of the Senior
Care Options (SCO) Program (July 21, 2015). Retrieved from <a href="https://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf">https://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf</a>.
\7\ Medicare Payment Advisory Committee. ``Chapter 3, Care
coordination programs for dual-eligible beneficiaries.'' In June
2012 Report to Congress: Medicare and Health Care Delivery System
(June 16, 2012). Retrieved from <a href="https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/jun12_ch03.pdf">https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/jun12_ch03.pdf</a>.
\8\ Ibid.
\9\ CMS Medicare-Medicaid Coordination Office FY 2020 Report to
Congress, available at: <a href="https://www.cms.gov/files/document/reporttocongressmmco.pdf">https://www.cms.gov/files/document/reporttocongressmmco.pdf</a>.
---------------------------------------------------------------------------
An increasing number of dually eligible individuals are enrolled in
managed care plans. The broader trend toward managed care presents
opportunities for integrated care. It also presents risks for further
fragmentation and complexity. In fact, while enrollment in integrated
care has increased, it is also becoming increasingly likely that dually
eligible individuals are in one sponsor's Medicaid MCO and a
competitor's D-SNP. The result: Duplicative health risk assessments
(HRAs); multiple ID cards, handbooks, and provider and pharmacy
directories; strong incentives for cost-shifting where possible;
multiple care coordinators; more complex billing processes for
providers; and similar other fragmented care, burdens, or increased
costs.
The Medicare Payment Advisory Commission (MedPAC), Medicaid and
CHIP Payment and Access Commission (MACPAC), and a wide array of health
policy organizations have long pushed for greater CMS investment in
integrated care. Over the last few years, MedPAC and MACPAC have
written extensively on opportunities to promote integration through
managed care policies.\10\
---------------------------------------------------------------------------
\10\ Most recently, see MACPAC's June 2021 Report to Congress
and MedPAC's June 2019 Report to Congress.
---------------------------------------------------------------------------
Section 2602 of the Patient Protection and Affordable Care Act of
2010 (Pub. L. 111-148) (Affordable Care Act) established the Medicare-
Medicaid Coordination Office (MMCO) within CMS to better align and
integrate benefits for dually eligible individuals, including specific
responsibilities. Section 50311(b)(2) of the Bipartisan Budget Act
(BBA) of 2018 amended that provision to also charge MMCO with--
<bullet> Developing regulations and guidance related to the
integration or alignment of policy and oversight under Medicare and
Medicaid regarding D-SNPs; and
<bullet> Serving as the single point of contact for States on D-SNP
issues.
In two recent MA/Part D rulemakings, CMS has adopted regulations
\11\ to: (1) Promote better information sharing between States and D-
SNPs; (2) unify appeals processes across Medicare and Medicaid for
certain D-SNPs that are also capitated for Medicaid benefits; and (3)
phase out ``D-SNP look-alike'' plans that enroll a high percentage of
dually eligible individuals without meeting the requirements for D-
SNPs.\12\
---------------------------------------------------------------------------
\11\ For a discussion of codified requirements for information
sharing between States and D-SNPs and unified appeals processes, see
the final rule titled ``Medicare and Medicaid Programs; Policy and
Technical Changes to the Medicare Advantage, Medicare Prescription
Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE),
Medicaid Fee-For-Service, and Medicaid Managed Care Programs for
Years 2020 and 2021,'' (84 FR 15710 through 15717 and 84 FR 15720
through 15744) at: <a href="https://www.federalregister.gov/documents/2019/04/16/2019-06822/medicare-and-medicaid-programs-policy-and-technical-changes-to-the-medicare-advantage-medicare">https://www.federalregister.gov/documents/2019/04/16/2019-06822/medicare-and-medicaid-programs-policy-and-technical-changes-to-the-medicare-advantage-medicare</a>. For a
discussion of codified contract limitations on D-SNP look-alike
plans, see the final rule titled ``Medicare Program; Contract Year
2021 Policy and Technical Changes to the Medicare Advantage Program,
Medicare Prescription Drug Benefit Program, and Medicare Cost Plan
Program,'' (85 CFR 33805 through 33820) at: <a href="https://www.federalregister.gov/documents/2020/06/02/2020-11342/medicare-program-contract-year-2021-policy-and-technical-changes-to-the-medicare-advantage-program">https://www.federalregister.gov/documents/2020/06/02/2020-11342/medicare-program-contract-year-2021-policy-and-technical-changes-to-the-medicare-advantage-program</a>.
\12\ For a discussion of D-SNP look-alikes, see the proposed
rule titled ``Medicare and Medicaid Programs; Contract Year 2021 and
2022 Policy and Technical Changes to the Medicare Advantage Program,
Medicare Prescription Drug Benefit Program, Medicaid Program,
Medicare Cost Plan Program, and Programs of All-Inclusive Care for
the Elderly,'' (85 FR 9018 through 9025) at: <a href="https://www.govinfo.gov/content/pkg/FR-2020-02-18/pdf/2020-02085.pdf">https://www.govinfo.gov/content/pkg/FR-2020-02-18/pdf/2020-02085.pdf</a>.
---------------------------------------------------------------------------
Despite this recent work, additional actions are needed to maximize
the potential of D-SNPs to deliver person-centered integrated care--and
ultimately better health outcomes and independence in the community--
for dually eligible older adults, people with disabilities, and people
with end stage renal disease.
Maximizing the potential of D-SNPs to achieve these goals will
require a sustained effort over multiple years, including--
<bullet> Partnership with and technical assistance for States;
<bullet> Technical assistance and support for providers and health
plans, especially among the local not-for-profit plans that
disproportionately serve Medicaid beneficiaries;
<bullet> Monitoring and oversight that protects beneficiaries and
promotes person-centered coordination of care; and
<bullet> Federal rulemaking to raise the bar on integration without
excessive disruption for enrollees.
We are working to improve and increase options for more integrated
care in a variety of ways, including through D-SNPs and Medicare-
Medicaid Plans (MMPs).
a. Dual Eligible Special Needs Plans
Special needs plans (SNPs) are MA plans created by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L.
108-173) that are specifically designed to provide targeted care and
limit enrollment to special needs individuals. Under section 1859(b)(6)
of the Act, SNPs restrict enrollment to certain populations. The most
common type of SNP is a dual eligible special needs plan, or D-SNP, in
which enrollment is limited to individuals entitled to medical
assistance under a State plan under title XIX of the Act.
D-SNPs are intended to integrate or coordinate care for dually
eligible individuals more effectively than standard MA plans or the
original Medicare fee-for-service (FFS) program by focusing enrollment
and care management on this population. As of January 2021,
approximately 3.3 million dually eligible individuals (more than 1 of
every 4 dually eligible individuals) were enrolled in 627 D-SNPs.\13\
---------------------------------------------------------------------------
\13\ Centers for Medicare & Medicaid Services. SNP Comprehensive
Report (January 2021). Retrieved from <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html</a>.
---------------------------------------------------------------------------
[[Page 1851]]
Federal statute and implementing regulations have established
several requirements for D-SNPs in addition to those that apply to all
MA plans to promote coordination of care, including HRA requirements as
described in section 1859(f)(5)(A)(ii)(I) of the Act and at Sec.
422.101(f)(1)(i), evidence-based models of care (MOCs) as described in
section 1859(f)(5)(A)(i) of the Act and at Sec. 422.101(f), and
contracts with State Medicaid agencies as described in section
1859(f)(3)(D) of the Act and at Sec. 422.107. The State Medicaid
agency contracting requirement allows States to require greater
integration of Medicare and Medicaid benefits from the D-SNPs in their
markets.
Most recently, section 50311(b) of the BBA of 2018 amended section
1859 of the Act to add new requirements for D-SNPs, beginning in 2021,
including minimum integration standards, coordination of the delivery
of Medicare and Medicaid benefits, and unified appeals and grievance
procedures for integrated D-SNPs, the last of which we implemented
through regulation to apply to certain D-SNPs with exclusively aligned
enrollment, termed ``applicable integrated plans.'' These requirements,
along with clarifications to existing regulations, were codified in the
``Medicare and Medicaid Programs; Policy and Technical Changes to the
Medicare Advantage, Medicare Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service,
and Medicaid Managed Care Programs for Years 2020 and 2021'' final rule
(84 FR 15696 through 15744) (hereinafter referred to as the April 2019
final rule).\14\
---------------------------------------------------------------------------
\14\ See <a href="https://www.govinfo.gov/content/pkg/FR-2019-04-16/pdf/2019-06822.pdf">https://www.govinfo.gov/content/pkg/FR-2019-04-16/pdf/2019-06822.pdf</a>.
---------------------------------------------------------------------------
For a more comprehensive review of D-SNPs and legislative history,
see the proposed rule titled ``Medicare and Medicaid Programs; Contract
Year 2021 and 2022 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid
Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care
for the Elderly,'' (85 FR 9018 through 9021) which appeared in the
Federal Register on February 18, 2020 (hereinafter referred to as the
February 2020 proposed rule).\15\
---------------------------------------------------------------------------
\15\ See <a href="https://www.govinfo.gov/content/pkg/FR-2020-02-18/pdf/2020-02085.pdf">https://www.govinfo.gov/content/pkg/FR-2020-02-18/pdf/2020-02085.pdf</a>.
---------------------------------------------------------------------------
b. Medicare-Medicaid Plans
To test additional models of integrated care, we established the
Medicare-Medicaid Financial Alignment Initiative (FAI) in July 2011
with the goal of improving outcomes and experiences for full-benefit
dually eligible individuals while reducing costs for both States and
the Federal government. Although the FAI includes two models, the model
with the largest number of States participating is a capitated model
through which CMS, the State, and health plans (called Medicare-
Medicaid Plans or MMPs) enter into three-way contracts to coordinate
the full array of Medicare and Medicaid services for members.
Certain elements of the capitated model demonstrations vary by
State, but all MMPs include--
<bullet> A beneficiary advisory committee or governance board to
provide ongoing input on plan operations;
<bullet> An integrated set of member materials, including provider
directories, beneficiary notices, and a single ID card;
<bullet> Person-centered care planning, including HRAs and care
plans;
<bullet> Care coordination and assistance with care transitions;
<bullet> Aligned Medicare and Medicaid plan enrollment and
disenrollment effective dates;
<bullet> Medicare provider network adequacy standards specific to
the dually eligible individual population;
<bullet> Integrated grievance and appeal processes at the plan
level;
<bullet> Joint oversight by CMS and the States through contract
management teams;
<bullet> Benefit flexibility, an integrated medical loss ratio
(MLR), and other financing provisions intended to promote person-
centeredness and mitigate incentives for cost-shifting across programs;
and
<bullet> A set of CMS core and State-specific quality measures, a
subset of which are part of performance-based risk through a quality
withhold on the payment to the MMP.
CMS and States partnered with MMPs to create a seamless experience
for beneficiaries, but MMPs operate as both MA organizations and
Medicaid managed care organizations. As such, unless waived by CMS,
MMPs are required to comply with Medicaid managed care requirements
under 42 CFR part 438, with MA (also known as Part C) requirements in
title XVIII of the Act as well as 42 CFR part 422 and, with regard to
the Medicare prescription drug benefit, Part D requirements in title
XVIII of the Act and 42 CFR part 423. Section 1115A of the Act (as
added by section 3021 of the Affordable Care Act) authorizes waiver of
certain Medicare provisions and CMS used that authority to waive
several Medicare requirements for the FAI. For States participating in
the capitated model, CMS typically uses authority under section
1115(a), 1915(b), 1915(c), or 1932(a) of the Act to waive or exempt the
State from certain provisions of title XIX of the Act or establish the
authority to deliver Medicaid services through managed care.
As of July 2021, there are 39 MMPs in nine States serving
approximately 400,000 members.\16\
---------------------------------------------------------------------------
\16\ MMP enrollment as of December 2020. See CMS Monthly
Enrollment by Contract Report (December, 2020). Retrieved from
<a href="https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldatamonthly/enrollment-contract-2020-12">https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldatamonthly/enrollment-contract-2020-12</a>.
---------------------------------------------------------------------------
While an independent evaluation of the FAI is still underway, we
have already gleaned several lessons regarding integrated, managed care
from the capitated financial alignment model:
<bullet> Enrollee participation in governance helps identify and
address barriers to high-quality, coordinated care. Stakeholder
engagement has been an important tenet of the FAI since its inception.
We required participating States to work with a variety of
stakeholders, including beneficiaries and their advocates, as a
condition of demonstration approval and implementation processes. Some
have cultivated robust and impactful advisory bodies. For example,
Massachusetts developed a One Care Implementation Council,\17\ at least
half of whose membership is comprised of enrollees and/or their
representatives, charged with tracking quality of services, providing
support and input to the State, and promoting accountability and
transparency. The three-way contracts used in the capitated financial
alignment model require MMPs to establish enrollee advisory committees
and/or recruit enrollees to governing boards to ensure plans regularly
obtain enrollee input on issues of program management. These advisory
committees often provide input on enrollee materials, access to covered
services, outreach campaigns, and other topics. Not every advisory
committee operates at the same level, and many MMPs have had to
recalibrate their approaches to ensure robust participation over time,
but all have made strides toward seeking out and incorporating enrollee
feedback. We believe such mechanisms help MMPs
[[Page 1852]]
improve the experiences of dually eligible individuals.
---------------------------------------------------------------------------
\17\ For more information on the One Care Implementation
Council, see the Center for Consumer Engagement in Health Innovation
at Community Catalyst & the LeadingAge LTSS Center @UMass Boston.
``The One Care Implementation Council: Stakeholder Engagement Within
a Duals Demonstration Initiative.'' (June, 2018). Retrieved from
<a href="https://www.healthinnovation.org/resources/publications/body/One-Care-Implementation-Council-Review-June-2018-1.pdf">https://www.healthinnovation.org/resources/publications/body/One-Care-Implementation-Council-Review-June-2018-1.pdf</a>.
---------------------------------------------------------------------------
<bullet> Assessment processes are a vehicle for identifying and
addressing unmet need, particularly those related to social
determinants of health. MMPs are required to offer care coordination
services to each beneficiary, including an HRA of the enrollee's
physical, psychosocial, and functional status which meet all minimum
requirements for MA plans in section 1859(f)(5)(A)(ii) of the Act but
often include additional elements to assess social risk factors. As of
September 2020, MMPs had performed over 1.3 million HRAs, and in doing
so identified significant unmet need among members, particularly
related to food insecurity and housing instability.\18\ For example, we
commonly learn of HRAs identifying people with no regular source of
care, untreated chronic conditions, unsafe living conditions, and/or
imminent eviction or homelessness. By identifying these unmet needs
through the HRA process, MMPs are then able to address them with
interventions from care coordinators, connections to community
organizations, and by incorporating goals and actions into beneficiary
care plans.
---------------------------------------------------------------------------
\18\ MMP reported monitoring measure data. Measure data are
provided for informational purposes only and do not constitute
official evaluation results. Full measure specifications can be
found in the reporting requirements documents, available at: <a href="https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialAlignmentInitiative/MMPInformationandGuidance/MMPReportingRequirements.html">https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialAlignmentInitiative/MMPInformationandGuidance/MMPReportingRequirements.html</a>.
---------------------------------------------------------------------------
<bullet> Medicare-Medicaid integration correlates with high levels
of beneficiary satisfaction. MMP members report high levels of
satisfaction with their MMPs through member experience surveys. When
asked to rate their health plan on a scale from 0 to 10 (with 0 being
the worst possible and 10 being the best possible), 91 percent of
respondents rated their health plan and health care a 7 or higher in
2019, the most recent year for which data are available.\19\ Sixty-six
percent of all respondents rated their MMP a 9 or 10 in 2019, up from
59 percent in 2016.\20\ These ratings have improved continuously (by
five percentage points per year on average) since the MMPs started
reporting such data in 2015 and are on par with ratings in the broader
Medicare Advantage program.\21\
---------------------------------------------------------------------------
\19\ Centers for Medicare & Medicaid Services. Enrollee
Experiences in the Medicare-Medicaid Financial Alignment Initiative:
Results through the 2019 CAHPS Surveys. (October 2020) Retrieved
from <a href="https://www.cms.gov/files/document/faicahpsresults.pdf">https://www.cms.gov/files/document/faicahpsresults.pdf</a>.
\20\ Ibid.
\21\ CMS analysis of MMP and Medicare Advantage CAHPS data 2015-
2019.
---------------------------------------------------------------------------
<bullet> Carving in Medicaid behavioral health benefits helps
promote better coordination of behavioral health and physical health
services. Behavioral health conditions are pervasive among dually
eligible individuals. For example, nearly one-third of individuals who
are dually eligible for Medicare and Medicaid have been diagnosed with
a serious mental illness, such as schizophrenia, bipolar disorder, or
major depressive disorder, a rate almost three times higher than for
non-dually eligible Medicare beneficiaries.\22\ Fragmented physical and
behavioral health care, delivered across multiple providers and funding
sources, can decrease access to care and lead to poor health
status.\23\ MMPs in all capitated demonstration States except for
California and Michigan include Medicaid behavioral health benefits in
their plan benefit package. In California, specialty mental health
services and substance use disorder treatment covered by Medicaid are
financed and administered by county behavioral health departments, and
MMPs are required to coordinate with the counties for members served by
both entities. Coordination between the MMPs and the counties has
varied by county and has often been difficult; challenges include
confusion for plans over county-level variation on which services are
covered by the county or the MMP, limited behavioral health provider
resources to participate in interdisciplinary care teams, and legal and
communication barriers to sharing data between county providers and
MMPs.
---------------------------------------------------------------------------
\22\ Congressional Budget Office. ``Dual-Eligible Beneficiaries
of Medicare and Medicaid: Characteristics, Health Care Spending, and
Evolving Policies.'' (June, 2013). Retrieved from: <a href="https://www.cbo.gov/sites/default/files/113th-congress-2013-2014/reports/44308dualeligibles2.pdf">https://www.cbo.gov/sites/default/files/113th-congress-2013-2014/reports/44308dualeligibles2.pdf</a>. This report classified Medicare enrollees
as having a mental illness if they had a diagnosis from the previous
year of schizophrenia; major depressive, bipolar, and paranoid
disorders; or other major psychiatric disorders.
\23\ Medicaid and CHIP Payment and Access Commission.
``Integration of Behavioral and Physical Health Services in
Medicaid.'' (March, 2016). Retrieved from: <a href="https://www.macpac.gov/wp-content/uploads/2016/03/Integration-of-Behavioral-and-Physical-Health-Services-in-Medicaid.pdf">https://www.macpac.gov/wp-content/uploads/2016/03/Integration-of-Behavioral-and-Physical-Health-Services-in-Medicaid.pdf</a>.
---------------------------------------------------------------------------
<bullet> Integrated beneficiary communication materials can enhance
the beneficiary experience. The Medicare and Medicaid programs have
different, and sometimes inconsistent, requirements for how plans
communicate with individuals. CMS and partnering States, however,
require MMPs to provide a single set of integrated member materials
designed to meet Federal and State requirements and convey information
to members in a more streamlined fashion. CMS tested such materials
with beneficiaries to maximize readability and understanding.
<bullet> Effective joint oversight of integrated managed care
products is possible. Through the FAI, we have shown it is possible to
create a successful framework for joint State and CMS oversight and
contract management. Contract management teams (CMTs) consisting of
State Medicaid and CMS staff work hand in hand to assure compliance
with the relevant Medicare, Medicaid, and State requirements and MMP
three-way contract requirements, and to promote MMP performance in
meeting the needs and preferences of beneficiaries. Through each CMT,
State and CMS staff coordinate to jointly issue guidance and
operational clarification and, as needed, may coordinate to issue joint
CMS-State compliance actions. CMTs regularly meet with State ombudsman
organizations, State-convened advisory groups, and may also meet with
local stakeholders, such as beneficiary advocates, enabling more rapid
problem-solving and real-time feedback on plan performance and
beneficiary experience.\24\ CMS has also developed and refined audit
protocols specific to three-way contracts between CMS, the States, and
the MMPs, and CMS and State staff coordinate to avoid scheduling
conflicting Medicare and Medicaid audits that can cause a plan to split
resources between two regulators. Based on feedback from States and
MMPs and our own experiences for the last eight years, we believe these
joint oversight processes, along with having performance data specific
to the local MMPs, have improved communications and driven performance
improvement.
---------------------------------------------------------------------------
\24\ RTI International, ``Financial Alignment Initiative
Massachusetts Once Care: Third Evaluation Report,'' (April 2019),
Retrieved from: <a href="https://innovation.cms.gov/files/reports/fai-ma-thirdevalrpt.pdf">https://innovation.cms.gov/files/reports/fai-ma-thirdevalrpt.pdf</a>; RTI International, ``Financial Alignment
Initiative Michigan MI Health Link First Evaluation Report (Sept
2019), Retrieved from: <a href="https://innovation.cms.gov/files/reports/fai-mi-firstevalrpt.pdf">https://innovation.cms.gov/files/reports/fai-mi-firstevalrpt.pdf</a>; RTI International, ``Financial Alignment
Initiative MyCare Ohio: First Evaluation Report ``(Nov 15 2018),
Retrieved from: <a href="https://innovation.cms.gov/files/reports/fai-oh-firstevalrpt.pdf">https://innovation.cms.gov/files/reports/fai-oh-firstevalrpt.pdf</a>; RTI International, ``Financial Alignment
Initiative South Carolina Healthy Connections Prime: First
Evaluation Report (Sept 2019), Retrieved from: <a href="https://innovation.cms.gov/files/reports/fai-sc-firstevalrpt.pdf">https://innovation.cms.gov/files/reports/fai-sc-firstevalrpt.pdf</a>.
---------------------------------------------------------------------------
<bullet> Integrated care and joint oversight provide a platform for
quality improvement. The capitated model demonstrations have shown it
is
[[Page 1853]]
possible to effectively incentivize innovation and investment for
better serving the dually eligible population. MMPs and CMTs
collaborate on continuous performance improvement. Like MA plans, MMPs
report quality and performance data such as Consumer Assessment of
Healthcare Providers and Systems (CAHPS) and Healthcare Effectiveness
Data and Information Set (HEDIS) at the contract level. Because the MMP
is the only plan under the three-way contract, CMS and the State have
access to performance and quality data specific to each individual MMP.
(This is similar to how States generally approach Medicaid managed care
contracts and quality reporting. In contrast, a D-SNP may be one of
many plan benefit packages under a single MA contract, making it
difficult to get a true picture of a particular MA plan's performance.)
CMS routinely shares State and national performance data on CAHPS and
HEDIS metrics with States and MMPs to identify high and low performing
plans. Through the CMTs, State and CMS staff have worked with MMPs to
identify specific quality metrics to drive performance improvement and
have developed specific quality and performance improvement projects at
an MMP and/or demonstration level. These efforts have helped to drive
significant year-over-year improvement in CAHPS and HEDIS measures.
From 2016 to 2018, MMPs as a group improved performance on measures
related to care coordination like Care for Older Adults (by an average
of 17 percent across three separate measures) and Medication
Reconciliation Post-Discharge (by 54 percent), and on key outcome
measures like Controlling High Blood Pressure (by 16 percent) and Plan
All-Cause Readmissions (17 percent reduction for beneficiaries age 65
and over).\25\ Compared to MA plans as a group, MMPs improved at a
higher rate on these measures over the same time period. MA plans as a
group improved by an average of 5 percent across the Care for Older
Adults measures (although only D-SNPs report those measures) and by 32
percent on the Medication Reconciliation Post-Discharge measure, while
the Plan All-Cause Readmissions measure had a 16 percent reduction for
beneficiaries age 65 and over.\26\ Overall, MA plans saw no change to
performance on the Controlling High Blood Pressure measure.\27\
---------------------------------------------------------------------------
\25\ CMS analysis of the MMP performance on HEDIS data reported
2017-2019.
\26\ CMS analysis of Medicare Advantage performance on HEDIS
data reported 2017-2019.
\27\ Ibid.
---------------------------------------------------------------------------
<bullet> There is potential for market distortions in areas with
multiple options targeting the same population. The MMP experience has
shown that we can create a competitive market among MMPs with multiple
choices for beneficiaries in the same service area and maintain high
expectations for plans around care coordination and cost effectiveness.
However, it has also shown the potential for beneficiary confusion and
disruption in markets where MMPs are competing with other products
targeting dually eligible individuals, including D-SNPs and, more
recently, D-SNP look-alikes. For example, fully integrated D-SNPs (FIDE
SNPs) served the same population as MMPs that were under New York's
Fully Integrated Dual Advantage (FIDA) capitated model demonstration
and the FIDE SNPs were offered by the same parent organization as the
MMPs, creating confusion among beneficiaries and providers about each
program's role.\28\ Differences in Medicare capitation payments gave
parent organizations a financial incentive to prioritize enrollment in
FIDE SNPs over MMPs.\29\ In addition to the financial challenges, the
MMPs experienced low enrollment spread among a high number of MMPs \30\
due to providers not wanting to meet prescriptive care coordination
requirements and encouraging patients not to participate. In
California, D-SNP look-alikes emerged following the State's decision to
limit eligibility for D-SNPs to beneficiaries not otherwise eligible
for MMPs.\31\ In its June 2018 report to Congress, MedPAC describes
broker commissions as another factor incentivizing enrollment in the D-
SNP look-alike plans over the MMPs in States like California that
prohibit MMPs from using brokers.\32\ For a more thorough discussion of
market dynamics in New York and California, see MedPAC's June 2018
report to Congress.\33\ For a more comprehensive review of D-SNP look-
alike plans, see pages 9019-9021 in the February 2020 proposed
rule.\34\
---------------------------------------------------------------------------
\28\ Medicare Payment Advisory Committee. ``Chapter 9, Managed
care plans for dual eligible beneficiaries.'' In June 2018 Report to
Congress: Medicare and Health Care Delivery System (June 15, 2018).
Retrieved from <a href="https://www.medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0">https://www.medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0</a>.
\29\ Ibid.
\30\ Per MedPAC's June 2018 report, as of June 2017, 156,000
full-benefit dually eligible individuals were eligible to
participate in FIDA, but only 4,708 individuals (3 percent) were
enrolled among 14 MMPs.
\31\ Pursuant to Welfare and Institutions Code section
14132.277(d), for seven counties, DHCS only offered D-SNP contracts
(that is, contracts between the State and the D-SNP that are
required under 42 CFR 422.107 for an MA organization to offer a D-
SNP) to plans that were approved as of 1/1/13 and new enrollment
into those D-SNPs is limited to beneficiaries not otherwise eligible
for Medicare-Medicaid plans. The State also did not permit existing
D-SNPs to expand service area into the seven counties.
\32\ Medicare Payment Advisory Committee. ``Chapter 9, Managed
care plans for dual eligible beneficiaries.'' In June 2018 Report to
Congress: Medicare and Health Care Delivery System (June 15, 2018).
Retrieved from <a href="https://www.medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0">https://www.medpac.gov/docs/default-source/reports/jun18_ch9_medpacreport_sec.pdf?sfvrsn=0</a>.
\33\ Ibid.
\34\ As finalized in Sec. 422.514 by the ``Medicare Program;
Contract Year 2021 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program,
Medicaid Program, and Medicare Cost Plan Program'' (85 FR 33796
through 33911) (hereinafter referred as the May 2020 final rule),
CMS will no longer enter into a contract with a new D-SNP look-alike
beginning in CY 2022 or an existing D-SNP look-alike beginning in CY
2023.
---------------------------------------------------------------------------
<bullet> State investment is critical to successful implementation
of integrated care either through MMPs or D-SNPs. True integration of
Medicare and Medicaid requires long-term State participation. However,
interest and capacity in pursuing integrated care for dually eligible
individuals varies considerably from State to State, and sometimes from
year to year. One of the many lessons from the MMP experience has been
that standing up a demonstration of this scope requires significant
State resources. However, even outside of MMPs, many of the features of
integration also require significant State effort. States that have
successfully utilized D-SNP contracts to integrate or align Medicare
and Medicaid programmatic and administrative elements outside of the
FAI have also invested in building State capacity, including
establishing dedicated staff or contractors with Medicare knowledge and
expertise, building technical capacity to integrate Medicare and
Medicaid data, and creating analytic resources to support ongoing
program operations and oversight.\35\ For example, to maximize
integration opportunities, D-SNP members may also enroll in the same
organization's Medicaid plan. State investment in establishing
enrollment and assignment processes to enable alignment of Medicare and
Medicaid enrollment require upfront and ongoing monitoring resources.
---------------------------------------------------------------------------
\35\ A. Kruse and M. Herman Soper. State Efforts to Integrate
Care for Dually Eligible Beneficiaries: 2020 Update. Center for
Health Care Strategies, Inc., February 2020. Available at <a href="https://www.chcs.org/media/State-Efforts-to-Integrate-Care-for-Dually-Eligible-Beneficiaries_022720.pdf">https://www.chcs.org/media/State-Efforts-to-Integrate-Care-for-Dually-Eligible-Beneficiaries_022720.pdf</a>.
---------------------------------------------------------------------------
[[Page 1854]]
Since the outset of the FAI, our shared goal with State partners
has been to develop models that promote greater Medicare-Medicaid
integration that, if successful, could be implemented on a broader
scale. Below we propose to incorporate into the broader MA program many
of the MMP practices that successfully improved experiences for dually
eligible individuals.
2. Summary of D-SNP Proposals Related to MMP Characteristics
Many of the proposals that follow would incorporate certain MMP
policies into the regulations governing D-SNPs or, in several cases,
certain types of D-SNPs. We describe those proposals in greater detail
in this section of this proposed rule. Table 1 summarizes how our
proposals relate to MMP policies.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP12JA22.004
BILLING CODE 4120-01-C
3. Enrollee Participation in Plan Governance (Sec. 422.107)
CMS believes managed care plans derive significant value from
engaging enrollees in defining, designing, participating in, and
assessing their care systems.\36\ By soliciting and responding to
enrollee input, plans can better ensure that policies and procedures
are responsive to the needs, preferences, and values of enrollees and
their families and caregivers. One of the ways managed care plans can
engage dually eligible individuals is by including enrollees in plan
governance, such as establishing enrollee advisory committees and
placing enrollees on governing boards. Engaging enrollees in these ways
seeks to keep enrollee and caregiver voices front and center in plan
operations and can help plans achieve high-quality, comprehensive, and
coordinated care.\37\ Federal regulations for other programs, such as
the Programs of All-Inclusive Care for the Elderly and Medicaid managed
care plans that cover long-term services and supports (LTSS) include
requirements for stakeholder engagement and committees, including input
from beneficiaries. We describe these requirements later in this
section.
---------------------------------------------------------------------------
\36\ Centers for Medicare & Medicaid Services. (n.d.). Person &
Family Engagement Strategy: Sharing with Our Partners. Retrieved
from <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-and-Family-Engagement-Strategy-Summary.pdf">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Person-and-Family-Engagement-Strategy-Summary.pdf</a>.
\37\ 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/Member_Engagement/Video/Listening_to_Voices_of_Dually_Eligible_Beneficiaries">https://www.resourcesforintegratedcare.com/Member_Engagement/Video/Listening_to_Voices_of_Dually_Eligible_Beneficiaries</a>.
---------------------------------------------------------------------------
Stakeholder engagement has been an important tenet of the FAI since
its inception. As required by the three-way contracts between CMS,
States, and MMPs, all MMPs established enrollee advisory committees.
These enrollee advisory committees provide a mechanism for MMPs to
solicit feedback directly from enrollees, assisting MMPs in identifying
and resolving emerging issues, and ensuring they meet the needs of
dually eligible individuals. While three-way contract terms differ by
State, all three-way contracts require the enrollee advisory committees
to meet at least quarterly, be comprised of enrollees, family members,
and other caregivers that reflect the diversity of the demonstration
population, and provide regular feedback to the MMP's governing board.
MMPs have flexibility in conducting these meetings, including
determining how to recruit and train enrollees, number of participants,
[[Page 1855]]
discussion topics, and how feedback is disseminated and used.
CMS's contractor Resources for Integrated Care partnered with
Community Catalyst, a non-profit advocacy organization, to offer a
series of webinars and other written technical assistance to help
enhance MMPs' operationalization of these committees.\38\ In their
work, the Resources for Integrated Care and Community Catalyst
identified some practices leading to successful enrollee advisory
committees. These include MMP efforts to--
---------------------------------------------------------------------------
\38\ Resources for Integrated Care and Community Catalyst,
``Member Engagement in Plan Governance Webinar Series'', 2019.
Retrieved from: <a href="https://www.resourcesforintegratedcare.com/concepts/member_engagement">https://www.resourcesforintegratedcare.com/concepts/member_engagement</a>.
---------------------------------------------------------------------------
<bullet> Recruit enrollees through care coordinator referrals and
community outreach events;
<bullet> Listen to enrollee feedback;
<bullet> Be responsive to enrollee feedback by identifying
meaningful changes made because of comments shared and, if the plan is
not able to implement a suggestion, providing a rationale;
<bullet> Disseminate feedback to appropriate departments across the
plan;
<bullet> Promote consistent enrollee participation through supports
like transportation to the committee meetings, meals, and a stipend;
and
<bullet> Provide ongoing training to enrollees to help them feel
comfortable and empowered to provide feedback.\39\
---------------------------------------------------------------------------
\39\ 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/Member_Engagement/Video/Listening_to_Voices_of_Dually_Eligible_Beneficiaries">https://www.resourcesforintegratedcare.com/Member_Engagement/Video/Listening_to_Voices_of_Dually_Eligible_Beneficiaries</a>.
---------------------------------------------------------------------------
In late 2018, Federal and State officials led conversations with
MMPs to gain a better understanding of the enrollee advisory
committees, promising practices, challenges, and how plans are using
the feedback received from enrollees and caregivers. A significant
number of MMPs reported value from having an advisory committee and
that the committee contributes to operational improvements through: (1)
Understanding challenges with community resources and potential gaps in
services; (2) improving enrollee communications, including printed
materials and the website enhancements; (3) identifying barriers to
medication adherence and what adherence tools might be most useful to
enrollees; and (4) improving delivery of non-emergency transportation,
dental, vision, and over-the-counter benefits. A few MMPs reported a
neutral value of the advisory committee meetings, citing benefits from
enrollee feedback but also challenges in enrollee participation and
willingness to engage on issues beyond their personal circumstances.
Overall, though, the MMPs reported the committees provided a valuable
perspective that shapes the plan's approach to recovery, wellness, and
overall access to health care as well as prioritize areas where
additional assistance is needed for enrollees.
More recently, MMPs have utilized enrollee advisory committees to
gain insight into the effectiveness of specific enrollee materials. For
example, some MMPs have shared redacted care plans with enrollee
advisory committees for enrollee feedback. Other MMPs have shared draft
influenza vaccination outreach materials with their enrollee advisory
committees and used the quarterly meetings to discuss influenza
prevention. During 2020 and 2021, MMPs have used these committees to
discuss ways to educate enrollees about COVID-19 prevention and
vaccines. We have had the opportunity to observe some of these meetings
and found the dialogue between enrollees and their caregivers and the
MMPs to be open and constructive, with all parties interested in
sharing information, listening, and identifying solutions. Other
programs overseen by CMS include similar committees or mechanisms for
beneficiaries to provide feedback and have a role in plan
administration.
a. Participant Advisory Committees in PACE Organizations
In addition to MMPs, Programs of All-Inclusive Care for the Elderly
(PACE) organizations, per Sec. 460.62(b), must establish participant
advisory committees to advise the PACE organization governing body on
matters of concern to participants. The majority of the 51,000 PACE
participants are dually eligible individuals.\40\
---------------------------------------------------------------------------
\40\ CMS, Medicare Advantage, Cost, PACE, Demo, and Prescription
Drug Plan Contract Report--Monthly Summary Report (Data as of June
2021). Retrieved from: <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Contract-and-Enrollment-Summary-Report">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Contract-and-Enrollment-Summary-Report</a>.
---------------------------------------------------------------------------
CMS initially required PACE organizations to establish consumer
advisory committees as part of the Federal regulations codifying the
PACE program in a November 1999 interim final rule with comment period
(IFC) for PACE (64 FR 66234). The November 1999 IFC noted that consumer
participation through advisory committees is a ``well accepted
community organization vehicle to maximize the involvement of consumers
in a program designed to serve them'' and that through the use of a
consumer advisory committee consumers are also ``likely to feel a
greater stake in the operation of the program'' (64 FR 66242). The
original regulation, codified at Sec. 460.62, required PACE
participants and participant representatives to comprise the majority
of committee membership, but there was no Federal requirement relating
to how frequently PACE organizations were required to convene the
committees.
In a December 2006 final rule (71 FR 71244 through 71337), we made
minor revisions to the PACE consumer advisory committee regulation text
at Sec. 460.62, including changing the name to participant advisory
committee (71 FR 71265). We also clarified in the preamble that the
final rule was not specifying the size of the participant advisory
committee but that we expected each committee to be representative of
the size and population of the PACE organization's participants.
The requirements at Sec. 460.62 allow PACE organizations
flexibility in determining the frequency, scope, and participation on
these advisory committees. Through its many years of experience
overseeing PACE organizations, CMS has learned that PACE organizations
value the participant advisory committees as an important way to
receive direct feedback from PACE participants to improve program
policy and operations. Attendance at participant advisory committees
may include PACE organization leadership, including executive directors
and PACE center directors. Since PACE participants visit the PACE
center at least once per week, feedback provided by PACE participants
at the participant advisory committees is generally focused on
challenges with transportation between the PACE center and their
residences and preferences for meals and activities provided at the
PACE center. Per Sec. 460.62(c), PACE organizations must have a
participant representative on their governing body. These participant
representatives act in part as a liaison of the participant advisory
committee to the PACE organization governing body and the participant
advisory committee, presenting issues from the participant advisory
committee to the governing body. The link between the participant
advisory committee and the governing body helps to elevate issues
raised by participants to PACE organization leadership.
[[Page 1856]]
b. Member Advisory Committees in Medicaid Managed Care Plans
Medicaid managed care plans that cover long-term services and
supports (LTSS) are also required to solicit active member and other
stakeholder input through the use of a member advisory committee.
Recognizing that stakeholder engagement is an important member
protection and is critical to the success of Medicaid managed LTSS
programs, CMS requires certain Medicaid managed care plans providing
LTSS to establish and maintain a member advisory committee. Per 42 CFR
438.110, as adopted in the ``Medicaid and Children's Health Insurance
Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in
Managed Care, and Revisions Related to Third Party Liability'' final
rule (81 FR 27655 through 27658) (hereinafter referred to as the May
2016 final rule), when LTSS are covered under a risk contract between a
State and a Medicaid managed care plan (that is a Medicaid managed care
organization (MCO), prepaid inpatient health plan (PIHP), or prepaid
ambulatory health plan (PAHP)), each Medicaid managed care plan must
establish a member advisory committee. The committee must include at
least a reasonably representative sample of the LTSS population, or
other individuals representing those members, covered under the
contract with the Medicaid managed care plan. CMS designed this
requirement in a way that gives managed care plans covering LTSS
flexibility to work with their stakeholder communities to establish the
most effective member engagement process.
c. Proposal for D-SNP Enrollee Advisory Committees
We believe that the establishment and maintenance of an enrollee
advisory committee is a valuable beneficiary protection to ensure that
enrollee feedback is heard by D-SNPs and to help identify and address
barriers to high-quality, coordinated care for dually eligible
individuals. Therefore, we propose at Sec. 422.107(f) that any MA
organization offering one or more D-SNPs in a State must establish and
maintain one or more enrollee advisory committees to solicit direct
input on enrollee experiences. We also propose at Sec. 422.107(f) that
the committee include a reasonably representative sample of individuals
enrolled in the D-SNP(s) and solicit input on, among other topics, ways
to improve access to covered services, coordination of services, and
health equity for underserved populations.
We propose to establish the new paragraph at Sec. 422.107(f) under
our authority at section 1856(b)(1) of the Act to establish in
regulation other standards not otherwise specified in statute that are
both consistent with Part C statutory requirements and necessary to
carry out the MA program and our authority at section 1857(e) of the
Act to adopt other terms and conditions not inconsistent with Part C as
the Secretary may find necessary and appropriate. We believe that a
requirement for an MA organization offering one or more D-SNPs to
establish one or more enrollee advisory committees is not inconsistent
with either the Part C statute or administration of the MA program.
While current law does not impose such a requirement, our experience
with existing requirements for MMPs and PACE demonstrates that the use
of advisory committees improves plans' ability to meet their enrollees'
needs by providing plans with a deeper understanding of the communities
the plans serve and the challenges and barriers their enrollees face,
as well as serving as a convenient mechanism to obtain enrollee input
on plan policy and operational matters. Our experience also suggests
that advisory committees complement other mechanisms for enrollee
feedback--such as surveys, focus groups, and complaints--with most
advisory committees featuring longer-term participation by enrollees
who can share their lived experiences while also learning how to best
advocate over time for broader improvements for all enrollees. We
believe the performance of all D-SNPs would benefit from this new
requirement. Further, this requirement would be consistent with the
existing requirement at Sec. 438.110 for Medicaid plans to establish
member advisory committees when those Medicaid managed care plans cover
LTSS.
While we describe the proposed advisory committee at Sec.
422.107(f) as an enrollee advisory committee consistent with the use of
the term ``enrollee'' in MA regulations we note that ``enrollee'' under
the proposed Sec. 422.107(f) requirement for D-SNPs has the same
meaning as ``member'' under the Sec. 438.110 requirement for Medicaid
plans.
We believe that D-SNPs should work with enrollees and their
representatives to establish the most effective and efficient process
for enrollee engagement. We expect the evolution and adoption of
telecommunications technology, including as experienced during the
COVID-19 public health emergency, will mean that the most effective
modalities for enrollee input may change over time. Therefore, we
choose not to propose Federal requirements as to the specific
frequency, location, format, participant recruiting and training
methods, or other parameters for these committees beyond certain
minimum requirements. Further, our proposal includes flexibility for MA
organizations in how they structure their enrollee advisory
committee(s). Though we are choosing to be nonprescriptive on meeting
frequency, location, format, enrollee recruitment, training, and other
parameters, we encourage D-SNPs to adopt identified best practices \41\
to ensure advisory committee meetings are accessible to all enrollees,
including but not limited to enrollees with disabilities, limited
literacy (including limited digital literacy), and lack of meaningful
access technology and broadband.
---------------------------------------------------------------------------
\41\ Resources for Integrated Care and Community Catalyst,
``Engaging Members in Plan Governance'', 2019. Retrieved from:
<a href="https://www.resourcesforintegratedcare.com/node/433#PlanGov">https://www.resourcesforintegratedcare.com/node/433#PlanGov</a>.
---------------------------------------------------------------------------
First, we propose that the MA organization offering one or more D-
SNP(s) in a State must have one or more enrollee advisory committees
that serve the D-SNP(s) offered by the MA organization in that State.
Under our proposed rule, an MA organization would be able to choose
between establishing one single enrollee advisory committee for one or
multiple D-SNPs in that State or by establishing more than one
committee in that State to meet proposed Sec. 422.107(f).
Second, we propose that the advisory committee must have a
reasonably representative sample of enrollees of the population
enrolled in the dual eligible special needs plan or plans, or other
individuals representing those enrollees. By using the phrase
``representative sample'' in the regulation text, we intend D-SNPs to
incorporate multiple characteristics of the total enrollee population
of the D-SNP(s) served by the enrollee committee, including but not
limited to geography and service area, and demographic characteristics.
An MA organization that offers separate D-SNPs in multiple counties in
a State could decide to convene one enrollee advisory committee to
solicit feedback across the membership of all these D-SNP plans as long
as that committee's participants reasonably represent the totality of
the D-SNP membership. Alternatively, this MA organization could convene
an enrollee advisory committee for each D-SNP in each county where the
D-SNP is offered. The MA organization could also choose to implement a
combination
[[Page 1857]]
of the aforementioned approaches, such as establishing an enrollee
advisory committee that solicits enrollees from a D-SNP offered in one
county and establishing an enrollee advisory committee with enrollees
representing D-SNPs offered in more than one county. For example, a MA
organization that offers separate D-SNPs in Broward, Hillsborough, and
Orange counties in Florida could establish one enrollee advisory
committee that convenes membership representative of these distinct
regions of Florida via virtual communications methods, or it could
establish separate enrollee advisory committees in each county, or it
could implement some combination of these approaches. Similarly, for MA
organizations that offer separate D-SNPs serving full-benefit dually
eligible individuals and partial-benefit dually eligible individuals in
the same State, proposed Sec. 422.107(f) provides flexibility for MA
organizations to solicit enrollee input through one or more committees
where separate committees might represent specific eligibility groups.
Ensuring that the enrollee advisory committee is representative of the
covered population of the D-SNP(s) that are served by the committee is
key to achieving the goals of requiring an enrollee advisory committee.
Finally, we propose that the advisory committee must, at a minimum,
solicit input on ways to improve access to covered services,
coordination of services, and health equity among underserved
populations, which is a CMS priority aligned with Executive Order 13985
on Advancing Racial Equity and Support for Underserved Communities
Through the Federal Government (January 20, 2021). CMS encourages D-
SNPs to consider the CMS Office of Minority Health Disparities Impact
Statement as a potential tool to improve health equity for underserved
populations among their enrollment.\42\ Our proposal does not specify
other responsibilities or obligations for the committee, but we
encourage D-SNPs to solicit input from enrollees on other topics will
be part of the committee's responsibilities.
---------------------------------------------------------------------------
\42\ CMS Office of Minority Health, Health Equity Technical
Assistance. Retrieved from: <a href="https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/Health-Equity-Technical-Assistance">https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/Health-Equity-Technical-Assistance</a>.
---------------------------------------------------------------------------
Specifically, we propose the following amendments to Sec. 422.107:
<bullet> Revise the section heading from ``Special needs plans and
dual eligible: Contract with State Medicaid Agency'' to ``Requirements
for dual eligible special needs plans'' to reflect how, as amended,
Sec. 422.107 will address D-SNP requirements, such as the enrollee
advisory committee, in addition to the State Medicaid agency contracts
and their content; and
<bullet> Add new paragraph (f) to require that any MA organization
offering one or more D-SNPs in a State must establish and maintain one
or more enrollee advisory committees that serve the D-SNPs offered by
the MA organization, with at least a reasonably representative sample
of the population enrolled in the dual eligible special needs plan or
plans, or other individuals representing those enrollees, and solicit
input on, among other topics, ways to improve access to covered
services, coordination of services, and health equity for underserved
populations.
An MA organization that offers one or more D-SNPs and offers (or is
under a parent organization that offers) one or more Medicaid managed
care plans that cover long term services and supports--including the MA
organizations associated with all FIDE SNPs and most HIDE SNPs--would
be subject to our proposal and Sec. 438.110. In some circumstances,
especially among FIDE SNPs and HIDE SNPs, we expect that organizations
could meet the requirements in our proposal and Sec. 438.110 through
one enrollee advisory committee. Section 438.110(b) requires the member
advisory committees to include at least a reasonably representative
sample of the LTSS populations covered, but it does not preclude the
membership of other enrollees as well. Therefore, an advisory committee
could, in some cases, be reasonably representative of both the LTSS
population and the D-SNP, even if enrollment in the D-SNP is not
limited to LTSS users. Some State Medicaid agency contracts, such as
those in Idaho, Massachusetts, Minnesota, New Jersey, and Pennsylvania,
already require member advisory committees for FIDE SNPs that operate
in those States in compliance with Sec. 438.110, because the MCOs
affiliated with those FIDE SNPs cover LTSS. Therefore, based on our
review of State Medicaid agency contracts, we expect that a number of
FIDE SNPs and HIDE SNPs affiliated with Medicaid managed care plans
that cover LTSS already operate enrollee advisory committees that would
comply with our proposal and Sec. 438.110. The proposed regulation
permits an organization that operates a D-SNP that is affiliated with a
Medicaid managed care plan to use one enrollee advisory committee to
meet both the requirement under Sec. 438.110 and the requirement
proposed at Sec. 422.107(f), when all the criteria in both regulations
are met and the State permits this arrangement. In other circumstances,
it may not be feasible for an organization to operate a single enrollee
advisory committee that meets the requirements of our proposal and
Sec. 438.110. Those organizations would need to operate multiple
enrollee advisory committees.
Our experience with MMPs establishing and maintaining enrollee
advisory committees demonstrates that these plans have found the
committees useful and carefully consider feedback provided by enrollees
to inform plan decisions without prescriptive Federal requirements for
the committees. As a result, we are not proposing specific prescriptive
requirements for how D-SNPs must interact with and use these enrollee
committees. However, we solicit comments on our proposal, including
whether we should include more prescriptive requirements on how D-SNPs
select enrollee advisory committee participants, training processes on
creating and running a successful committee, the responsibilities of
the enrollee advisory committees, and additional topics for enrollee
input, and whether we should limit the enrollee advisory committee
proposed at Sec. 422.107(f) to a subset of D-SNPs. We also solicit
comments on whether our approach to allow MA organizations to meet the
requirements in proposed Sec. Sec. 422.107(f) and 438.110 through one
enrollee advisory committee could dilute the Sec. 438.110 requirement
by detracting from the focus on LTSS enrollees. Consistent with PACE,
if our proposal is finalized, we would update the CMS audit protocols
for D-SNPs to request documentation of enrollee advisory committee
meetings. As we learn about the implementation experiences of these
committees, if proposed Sec. 422.107(f) is finalized, we would
consider more prescriptive requirements in the future, if needed.
4. Standardizing Housing, Food Insecurity, and Transportation Questions
on Health Risk Assessment (Sec. 422.101)
Section 1859(f)(5)(A)(ii)(I) of the Act requires each SNP to
conduct an initial assessment and an annual reassessment of the
individual's physical, psychosocial, and functional needs using a
comprehensive risk assessment tool that CMS may review during oversight
activities, and ensure that the results from the initial assessment and
annual reassessment conducted for each individual enrolled in the plan
are addressed in the individual's
[[Page 1858]]
individualized care plan. We codified this requirement at Sec.
422.101(f)(1)(i) as a required component of the D-SNP's MOC. In
practice, we allow each SNP to develop its own HRA, as long as it meets
the statutory and regulatory requirements.\43\ In the final rule titled
``Medicare and Medicaid Programs; Contract Year 2022 Policy and
Technical Changes to the Medicare Advantage Program, Medicare
Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan
Program, and Programs of All-Inclusive Care for the Elderly'' (86 FR
5864) (hereinafter referred to as the January 2021 final rule), we
noted that D-SNPs also receiving capitation for Medicaid services may
combine their Medicare-required HRA with a State Medicaid-required HRA
to reduce assessment burden for enrollees (86 FR 5879). Certain social
risk factors can lead to unmet social needs that directly influence an
individual's physical, psychosocial, and functional status.\44\ This is
particularly true for food insecurity, housing instability, and access
to transportation. The following are examples of actions that CMS has
taken since 2014 to address social risk through the identification and
standardization of screening for risk factors:
---------------------------------------------------------------------------
\43\ In the CY 2016 Call Letter (an attachment to the
Announcement of Calendar Year (CY) 2016 Medicare Advantage
Capitation Rates and Medicare Advantage and Part D Payment Policies)
released on April 6, 2015, CMS encouraged SNPs to adopt the
components in the CDC's ``A Framework for Patient-Centered Health
Risk Assessments'' tool but did not mandate their use. Specifically,
CMS encouraged the use of elements that identify the medical,
functional, cognitive, psychosocial and mental health care needs of
enrollees.
\44\ Hugh Alderwick and Laura M. Gottlieb, ``Meanings and
Misunderstandings: A Social Determinants of Health Lexicon for
Health Care Systems: Milbank Quarterly,'' Milbank Memorial Fund,
November 18, 2019, <a href="https://www.milbank.org/quarterly/articles/meanings-and-misunderstandings-a-social-determinants-of-health-lexicon-for-health-care-systems/">https://www.milbank.org/quarterly/articles/meanings-and-misunderstandings-a-social-determinants-of-health-lexicon-for-health-care-systems/</a>.
---------------------------------------------------------------------------
<bullet> IMPACT Act of 2014. The Improving Medicare Post-Acute Care
Transformation Act of 2014 Section 2(a) (Pub. L. 113-185), hereinafter
referred to as the IMPACT Act, amended the Social Security Act (the
Act) by adding section 1899B to the Act. Section 1899B(b)(1) of the Act
requires, in part, that the Secretary require certain post-acute care
(PAC) providers to submit standardized patient assessment data with
respect to certain categories of data. CMS finalized several
standardized patient assessment data requirements, including on social
determinants of health.\45\
---------------------------------------------------------------------------
\45\ See the ``Medicare and Medicaid Programs: CY 2020 Home
Health Prospective Payment System Rate Update; Home Health Value-
Based Purchasing Model; Home Health Quality Reporting Requirements;
and Home Infusion Therapy Requirements'' final rule (84 FR 39151
through 39161) as an example. In the interim final rule with comment
period (IFC) ``Medicare and Medicaid Programs, Basic Health Program
and Exchanges; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency and Delay of
Certain Reporting Requirements for the Skilled Nursing Facility
Quality Reporting Program'' (85 FR 27550 through 27629), CMS delayed
the compliance dates for these standardized patient assessment data
under the Inpatient Rehabilitation Facility (IRF) Quality Reporting
Program (QRP), Long-Term Care Hospital (LTCH) QRP, Skilled Nursing
Facility (SNF) QRP, and the Home Health (HH) QRP due to the public
health emergency. In the ``CY 2022 Home Health Prospective Payment
System Rate Update; Home Health Value-Based Purchasing Model
Requirements and Model Expansion; Home Health and Other Quality
Reporting Program Requirements; Home Infusion Therapy Services
Requirements; Survey and Enforcement Requirements for Hospice
Programs; Medicare Provider Enrollment Requirements; and COVID-19
Reporting Requirements for Long-Term Care Facilities'' final rule
(86 FR 62240 through 62431), CMS finalized its proposals to require
collection of standardized patient assessment data under the IRF QRP
and LTCH QRP effective October 1, 2022, and January 1, 2023 for the
HH QRP.
---------------------------------------------------------------------------
<bullet> Accountable Health Communities (AHC) Model. The AHC Model,
which is being tested under section 1115A of the Act, tests whether
systematically screening for health-related social needs and referrals
to community-based organizations to resolve identified unmet needs will
improve healthcare utilization and reduce costs. Over a five-year
period, organizations implementing the AHC Model, known as Bridge
Organizations, are screening community-dwelling Medicare and Medicaid
beneficiaries to identify their health-related social needs and
providing navigation assistance to connect those beneficiaries with
community services.\46\ Some Bridge Organizations are also engaging key
stakeholders in community-level continuous quality improvement
activities to align the community service capacity with the community's
service needs. For purposes of the model, the CMS Innovation Center
developed the AHC Health-Related Social Needs (HRSN) Screening Tool.
The tool asks 10 standardized questions that identify a patient's HRSNs
in five core domains: Housing instability, food insecurity,
transportation problems, utility help needs, and interpersonal
safety.<SUP>47 48</SUP> The first AHC Model evaluation report,
assessing model implementation from 2017 to 2020,\49\ demonstrated high
prevalence of social risk factors among eligible high-need
beneficiaries. Food insecurity was the most commonly reported social
risk factor.
---------------------------------------------------------------------------
\46\ CMS Innovation Center, ``Findings at a Glance: Accountable
Health Communities: Evaluation of Performance Years 1-3 (2017-
2020).'' Retrieved from: <a href="https://innovation.cms.gov/data-and-reports/2020/ahc-first-eval-rpt">https://innovation.cms.gov/data-and-reports/2020/ahc-first-eval-rpt</a>-fg.
\47\ CMS Innovation Center, ``The Accountable Health Communities
Health-Related Social Needs Screening Tool.'' Retrieved from:
<a href="https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf">https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf</a>.
\48\ There are now Logical Observation Identifiers Names and
Codes (LOINC) terms available for the AHC HRSN Screening Tool, as of
June 2021. For more information, see: <a href="https://loinc.org/loinc/96777-8/">https://loinc.org/loinc/96777-8/</a>.
\49\ RTI International, ``Accountable Health Communities (AHC)
Model Evaluation First Evaluation Report,'' Dec 2020. Retrieved
from: <a href="https://innovation.cms.gov/data-and-reports/2020/ahc-first-eval-rpt">https://innovation.cms.gov/data-and-reports/2020/ahc-first-eval-rpt</a>.
---------------------------------------------------------------------------
Many dually eligible individuals contend with multiple social risk
factors such as food insecurity, homelessness, lack of access to
transportation, and low levels of health literacy.\50\ Nonetheless, we
have not previously required that SNP HRAs specifically collect
information about these issues. We believe requiring SNPs to include
standardized questions about social risk factors is appropriate in
light of the impact these factors may have on health care and outcomes
for the enrollees in these plans and that access to this information
will better enable SNPs to design and implement effective models of
care.
---------------------------------------------------------------------------
\50\ Medicaid and CHIP Payment and Access Commission, ``Report
to Congress on Medicaid and CHIP,'' June 2020. Retrieved from:
<a href="https://www.macpac.gov/wp-content/uploads/2020/06/June-2020-Report-to-Congress-on-Medicaid-and-CHIP.pdf">https://www.macpac.gov/wp-content/uploads/2020/06/June-2020-Report-to-Congress-on-Medicaid-and-CHIP.pdf</a>.
---------------------------------------------------------------------------
We propose to amend Sec. 422.101(f)(1)(i) to require that all SNPs
(chronic condition special needs plans, D-SNPs, and institutional
special needs plans) include one or more standardized questions on the
topics of housing stability, food security, and access to
transportation as part of their HRAs. These questions will help SNPs
gather the necessary information in order to conduct a comprehensive
risk assessment of each individual's physical, psychosocial, and
functional needs as required at Sec. 422.101(f)(1)(i) and will inform
the development and implementation of each enrollee's comprehensive
individualized plan of care as required at Sec. 422.101(f)(1)(ii).
Rather than include the specific questions in regulation text, we
propose that the questions be specified in sub-regulatory guidance.
This would afford us some flexibility to modify questions to maintain
consistency with standardized questions that are developed for other
programs while still providing MA organizations with clear
requirements; we intend to provide ample notice to MA organizations of
any changes in the questions over time. Should we finalize our
proposal, SNPs would comply with the new requirement added to Sec.
422.101(f) by
[[Page 1859]]
including in their HRAs the standardized questions on these topics that
we would specify in sub-regulatory guidance. At a minimum, we intend to
align selected questions with the Social Determinants of Health (SDOH)
Assessment data element \51\ established as part of the USCDI v2, when
finalized and where applicable.
---------------------------------------------------------------------------
\51\ For more information, see: <a href="https://www.healthit.gov/isa/taxonomy/term/1801/uscdi-v2">https://www.healthit.gov/isa/taxonomy/term/1801/uscdi-v2</a>.
---------------------------------------------------------------------------
While we are proposing that the regulation text specify that the
wording of individual questions would be established through sub-
regulatory guidance, we provide here examples of the questions on these
topics used in other Medicare contexts to provide better context on the
proposed requirement and to solicit public comment. These examples
include the transportation question in the post-acute care patient/
resident instruments and the housing and food insecurity questions from
the AHC Model HRSN Screening Tool: \52\
---------------------------------------------------------------------------
\52\ For the Accountable Health Communities Health-Related
Social Needs Screening Tool, see <a href="https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf">https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf</a>. The PAC assessment utilized the
same transportation question as the AHC HRSN Tool.
---------------------------------------------------------------------------
Housing. What is your living situation today? \53\
---------------------------------------------------------------------------
\53\ Adapted from National Association of Community Health
Centers and partners, National Association of Community Health
Centers, Association of Asian Pacific Community Health
Organizations, Association OPC, Institute for Alternative Futures.
(2017). PRAPARE. <a href="http://www.nachc.org/research-and-data/prapare/">http://www.nachc.org/research-and-data/prapare/</a>.
<bullet> I have a steady place to live
<bullet> I have a place to live today, but I am worried about losing it
in the future
<bullet> I do not have a steady place to live (I am temporarily staying
with others, in a hotel, in a shelter, living outside on the street, on
a beach, in a car, abandoned building, bus or train station, or in a
park)
Food. Some people have made the following statements about their
food situation. Please answer whether the statements were OFTEN,
SOMETIMES, or NEVER true for you and your household in the last 12
months. Within the past 12 months, you worried that your food would run
out before you got money to buy more.\54\
---------------------------------------------------------------------------
\54\ Adapted from Hager, E.R., Quigg, A.M., Black, M.M.,
Coleman, S.M., Heeren, T., Rose-Jacobs, R., Cook, J.T., Ettinger de
Cuba, S.E., Casey, P.H., Chilton, M., Cutts, D.B., Meyers A.F.,
Frank, D.A. (2010). Development and Validity of a 2-Item Screen to
Identify Families at Risk for Food Insecurity. Pediatrics, 126(1),
26-32. doi:10.1542/peds.2009-3146.
<bullet> Often true
<bullet> Sometimes true
<bullet> Never true
Within the past 12 months, the food you bought just didn't last and
you didn't have money to get more.
<bullet> Often true
<bullet> Sometimes true
<bullet> Never true
Transportation. Has lack of transportation kept you from medical
appointments, meetings, work, or from getting things needed for daily
living? \55\
---------------------------------------------------------------------------
\55\ National Association of Community Health Centers and
partners, National Association of Community Health Centers,
Association of Asian Pacific Community Health Organizations,
Association OPC, Institute for Alternative Futures. (2017). PRAPARE.
<a href="http://www.nachc.org/research-and-data/prapare/">http://www.nachc.org/research-and-data/prapare/</a>.
<bullet> Yes, it has kept me from medical appointments or from getting
my medications
<bullet> Yes, it has kept me from non-medical meetings, appointments,
work, or from getting things that I need
<bullet> No
Our proposal would result in SNPs having a more complete picture
for each enrollee of the risk factors that may inhibit accessing care
and achieving optimal health outcomes and independence. We believe that
these questions are sufficiently related to and provide information on
enrollees' physical, psychosocial, and functional needs to be
appropriate to include the HRA. Having knowledge of this information
for each enrollee would better equip MA organizations to develop an
effective plan of care for each enrollee that identifies goals and
objectives as well as specific services and benefits to be provided.
Our proposal would also equip SNPs with person-level information that
would help them better connect enrollees to covered services (for
example, non-emergency medical transportation, when capitated by
Medicaid or covered as a supplemental benefit) and to social service
organizations and public programs that can help resolve housing
instability, food insecurity, transportation needs, or other
challenges. Coordinating care along these lines is consistent with the
obligations under Sec. 422.112(b)(3) for MA organizations that offer
coordinated care plans.
We are not explicitly proposing that SNPs be accountable for
resolving all risks identified in these assessment questions, but Sec.
422.101(f)(1)(i) requires that the results from the initial and annual
HRAs be addressed in the individualized care plan. Results of the HRAs
do not require SNPs to provide housing or food insecurity supports, but
having the results means that SNPs would need to consult with enrollees
about their unmet social needs, which may include homelessness and
housing instability, for example, in developing each enrollee's care
plan. A SNP could demonstrate this in several ways, consistent with its
MOC. For example, a SNP may make a referral to an appropriate community
partner, consistent with the individual's goals and preferences, to
assist in meeting these needs. The SNP may also adapt communication
methods to fit the individual's circumstances and take steps to
maximize access to covered services that may meet the individual's
needs and preferences, especially for supplemental benefits that may
help with housing instability, food insecurity, or transportation.
SNPs currently report to CMS the number of completed HRAs, and, as
part of the Medicare Part C Program Audit Protocols for SNP Care
Coordination, we currently review a sample of HRAs and ICPs.\56\
However, we do not currently collect specific data elements from HRAs
for all SNP enrollees, in part because the data elements vary from plan
to plan. By standardizing certain data elements, our proposal would
make those data elements available for collection by CMS from the SNPs
for all enrollees. (States can also use their contracts with D-SNPs at
Sec. 422.107 to require reporting of these data elements in the HRA to
the State or its designee.) While we continue to consider whether, how,
and when we would have the SNPs actually report data to CMS, we believe
having such information could help us to better understand the
prevalence and trends in certain social risk factors across SNPs and
further consider ways to support SNPs in promoting better outcomes for
their enrollees. We believe standardizing these data elements could
also eventually facilitate better data exchange among SNPs (such as
when an individual changes SNPs).
---------------------------------------------------------------------------
\56\ For more information, see: <a href="https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/ProgramAudits">https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/ProgramAudits</a>.
---------------------------------------------------------------------------
We understand that some States may separately require that Medicaid
managed care plans collect similar information, potentially creating
inefficiencies and added assessment burden on dually eligible
individuals who are asked similar, but not identical information, in
multiple HRAs. We believe that the benefit gained by all SNPs having
standardized information about these social risk factors outweighs this
potential risk. These questions build on other work across CMS. Where
States are interested in requiring
[[Page 1860]]
assessment questions, we recommend that States consider conforming to
the standardized questions we implement for use under this proposed
rule and, for integrated care programs, ensuring that plans do not need
to ask the same enrollees similar or redundant questions. However, we
also seek input from States about what questions they are using and how
we can best minimize assessment burden while ensuring that SNPs and
States are capturing actionable information on social risk factors.
We are considering several alternatives to our proposal. We are
considering requiring fewer or more assessment questions on additional
topics related to social risk factors or different combinations of
questions from the post-acute care patient/resident assessment
instruments and AHC Model HRSN Screening Tool. For example, we are
considering requiring that SNPs use the post-acute care patient/
resident assessment instruments questions on health literacy (``How
often do you need to have someone help you when you read instructions,
pamphlets, or other written material from your doctor or pharmacy?'')
and social isolation (``How often do you feel lonely or isolated from
those around you?''). We believe these would provide valuable insight
but are not proposing to require HRAs to include standardized questions
in these areas out of parsimony. We focused on the proposed areas since
there is a large evidence base suggesting they have a particularly
significant influence on the physical, psychosocial, and functional
needs of the enrollees.\57\ For example, our experience with the FAI
demonstrations has shown that lack of transportation can have a large
impact in securing needed health care services. Our proposal would not
preclude SNPs from asking additional questions related to these areas
as long as the minimum standardized questions (specified in CMS sub-
regulatory guidance pursuant to the regulation) are included as part of
the HRA.
---------------------------------------------------------------------------
\57\ See Kushel MB, Gupta R, Gee L, Haas JS. Housing instability
and food insecurity as barriers to health care among low-income
Americans. J Gen Intern Med. 2006;21(1):71-7. doi: 10.1111/j.1525-
1497.2005.00278.x.
---------------------------------------------------------------------------
We considered soliciting comment in this preamble on different
examples of questions on housing, food, and transportation other than
the examples included above, such as the housing-related questions from
the U.S. Department of Veteran Affairs' Homelessness Screening Clinical
Reminder \58\ or the housing-, food-, and transportation-related
questions from the Medicare Current Beneficiary Survey.\59\ We also
considered simply proposing that all HRAs address certain domains (for
example, housing), without authorizing CMS to specify the standardized
questions to be used. However, we believe the benefit of flexibility
for SNPs is outweighed by the challenges posed by use of multiple
different questions used by different SNPs across the country. Having
different questions that touch on the same topics in different ways
would pose difficulties for interoperability, comparability, and
reporting on these risk factors. We are considering specifying that the
new questions only apply to certain enrollees and not others. For
example, we are considering whether the questions on housing insecurity
would be relevant for enrollees in congregate housing. However, because
people may move between settings, including from an institutional
placement to the community, we believe that such a proposal would add
complexity without obvious benefit.
---------------------------------------------------------------------------
\58\ For more information, see the U.S. Department of Veteran
Affairs, VA National Center of Homelessness Among Veterans March
2014 Research Brief ``Using a Universal Screener to Identify
Veterans Experiencing Housing Instability'' at <a href="https://www.va.gov/HOMELESS/Universal_Screener_to_Identify_Veterans_Experiencing_Housing_Instability_2014.pdf">https://www.va.gov/HOMELESS/Universal_Screener_to_Identify_Veterans_Experiencing_Housing_Instability_2014.pdf</a>.
\59\ For more information, see <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/MCBS">https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/MCBS</a>.
---------------------------------------------------------------------------
Finally, due to the processes associated with developing HRA tools,
approval of MOCs, and MOC implementation, we would not enforce this
requirement until contract year 2024. However, we are also considering
whether to have our proposed requirement take effect at a later date,
such as contract year 2025, to allow MA organizations more time to work
our proposed new questions into their existing SNP HRAs. We welcome
comments on our proposal and these potential alternatives including
adding questions regarding health literacy, social isolation, or other
areas. We also welcome comments on when CMS would need to issue sub-
regulatory guidance providing the specific questions to be included in
the HRA to ensure that MA organizations would have sufficient time to
incorporate the required questions.
5. Refining Definitions for Fully Integrated and Highly Integrated D-
SNPs (Sec. Sec. 422.2 and 422.107)
Dually eligible individuals have an array of choices for how to
receive their Medicare coverage, including Original Medicare with a
standalone prescription drug plan, non-SNP MA plans, multiple types of
SNPs, and Programs of All-inclusive Care for the Elderly. Those choices
can be complex and, for some, overwhelming. An average Medicare
beneficiary will have access to 54 MA plans in 2022, excluding MMPs and
PACE, compared to 39 MA plans in 2020.\60\ In one extreme example,
dually eligible individuals in Los Angeles have over 85 choices for
Medicare coverage for 2022, including 70 MA plans, nine D-SNPs, two
FIDE SNPs, and five MMPs--more Medicare options to choose from than
Medicare-only beneficiaries.\61\
---------------------------------------------------------------------------
\60\ Information from 2022 Landscape Source Files. Retrieved
from <a href="https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn">https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn</a>. Excludes EGWPs.
\61\ Ibid.
---------------------------------------------------------------------------
Our own terminology is complex too. While we have defined terms
through rulemaking in Sec. 422.2, there remains nuance and variation
that may make it difficult for members of the public--and even the
professionals who support them--to readily understand what may be
unique about a certain type of plan or what a beneficiary can expect
from any FIDE SNP, for example. We propose several changes to how we
define FIDE SNPs and HIDE SNPs that we believe will ultimately help to
differentiate various types of D-SNPs and clarify options for
beneficiaries. Our proposals would lay the groundwork for potential
future improvements to Medicare Plan Finder and other communications to
help beneficiaries better understand their options for integrated
coverage of Medicare and Medicaid benefits.
a. Exclusively Aligned Enrollment for FIDE SNPs
Section 422.2 defines the term ``fully integrated dual eligible
special needs plan,'' most recently updated in the May 2020 final rule.
Under the current definition, FIDE SNPs are plans that: (i) Provide
dually eligible individuals access to Medicare and Medicaid benefits
under a single entity that holds both an MA contract with CMS and a
Medicaid managed care organization (MCO) contract under section 1903(m)
of the Act with a State Medicaid agency, (ii) under the capitated
Medicaid managed care contract, provide coverage, subject to some
limited flexibility for carve-outs, of primary care, acute care,
behavioral health, and LTSS, and coverage of nursing facility services
for a period of at least 180 days during the plan year; (iii)
coordinate delivery of covered Medicare and Medicaid benefits using
aligned care management and specialty care network methods for high-
risk beneficiaries; and
[[Page 1861]]
(iv) employ policies and procedures approved by CMS and the State to
coordinate or integrate beneficiary communication materials,
enrollment, communications, grievance and appeals, and quality
improvement.
The current definition of a FIDE SNP does not require that the MA
contract limit enrollment to the individuals who are enrolled in the
affiliated MCO. One benefit of FIDE SNP designation for the MA
organization is that the MA plan may qualify for a frailty adjustment
as part of CMS's risk adjustment of its MA capitation payments under
section 1853(a)(1) of the Act and Sec. 422.308(c); FIDE SNPs with a
similar average level of frailty (as determined by the Secretary) as
the PACE program may qualify for the frailty adjustment, which may
result in increased aggregate payment from CMS.
Section 422.2 also defines the term ``aligned enrollment'' as
referring to when a full-benefit dually eligible individual is an
enrollee of a D-SNP and receives coverage of Medicaid benefits from the
D-SNP or from a Medicaid MCO that is: (1) The same organization as the
MA organization offering the D-SNP; (2) its parent organization; or (3)
another entity that is owned and controlled by the D-SNP's parent
organization. When State policy limits a D-SNP's membership to
individuals with aligned enrollment, Sec. 422.2 refers to that
condition as exclusively aligned enrollment.
Exclusively aligned enrollment is an important design feature for
maximizing integration of care for all the D-SNP's enrollees. It
facilitates the use of integrated beneficiary communication materials
(because all beneficiaries in the D-SNP are also in the companion
Medicaid MCO), clarifies overall accountability for outcomes and
coordination of care, and makes feasible the requirement (effective
January 1, 2021) that the plan use unified grievance and appeals
procedures for both Medicare and Medicaid benefits.
All MMPs operate with exclusively aligned enrollment, and several
States require exclusively aligned enrollment for FIDE SNPs that
operate in the State by including this requirement in the State
Medicaid agency contract that is required for D-SNPs by Sec.
422.107(b). However, the current regulatory definition of FIDE SNP
permits certain forms of unaligned enrollment between Medicare and
Medicaid coverage. That is, a beneficiary may be in one parent
organization's FIDE SNP for coverage of Medicare services but a
separate company's Medicaid managed care plan (or in a Medicaid FFS
program) for coverage of Medicaid services.
In 2021, there are 69 FIDE SNPs in 12 States, enrolling 264,146
beneficiaries as of January 2021.\62\ Fifty-seven of those 69 FIDE SNPs
have exclusively aligned enrollment. Only Arizona, Pennsylvania, and
Virginia currently contract with FIDE SNPs without requiring
exclusively aligned enrollment.
---------------------------------------------------------------------------
\62\ CY 2021 data is from CMS review of CY 2021 State Medicaid
agency contracts submitted by FIDE SNPs. 2016 data is from Verdier,
J., A. Kruse, R. Lester, et al. 2016. State contracting with
Medicare Advantage dual eligible special needs plans: Issues and
options. Washington, DC: Integrated Care Resource Center. Retrieved
from <a href="https://www.integratedcareresourcecenter.com/sites/default/files/ICRC_DSNP_Issues__Options.pdf">https://www.integratedcareresourcecenter.com/sites/default/files/ICRC_DSNP_Issues__Options.pdf</a>.
---------------------------------------------------------------------------
We propose to amend the definition of ``fully integrated dual
eligible special needs plan'' at Sec. 422.2 with a new paragraph (5)
that requires, for 2025 and subsequent years, that all FIDE SNPs have
exclusively aligned enrollment. Our proposed change would move FIDE
SNPs toward greater integration in the provision of Medicare and
Medicaid benefits for dually eligible individuals and make the options
available to these beneficiaries simpler to understand. Requiring all
FIDE SNPs to have exclusively aligned enrollment would simplify the
ways we, States, and benefit counselors communicate about FIDE SNPs by
eliminating some of the confusing scenarios related to unaligned
enrollment that our current definition permits. It would allow all
enrollees to have their Medicare and Medicaid benefits explained under
the FIDE SNP clearly, which is made more difficult when some enrollees
are, but others are not, also enrolled in the affiliated Medicaid MCO.
Our proposed change promotes higher levels of Medicare-Medicaid
integration by ensuring that that all FIDE SNPs can deploy integrated
beneficiary communication materials and unify appeals and grievance
procedures for all the Medicare and Medicaid benefits covered through
the FIDE SNP and affiliated Medicaid MCO; such unified procedures are
not feasible when some FIDE SNP members do not receive the Medicaid
benefits from the same organization.
Under our proposed definition, all FIDE SNPs would (1) be capitated
for Medicaid services, with some permissible exceptions proposed at
Sec. 422.107(g) and (h) and discussed later in this section, for all
of their enrollees, and (2) based on meeting the definition of
applicable integrated plans in Sec. 422.561, operate unified appeals
and grievance processes and continue delivery of benefits during an
appeal. Ultimately, we believe this change in the definition of a FIDE
SNP will help simplify options and provide a better plan experience for
dually eligible beneficiaries, as they will be able to receive all
their covered Medicare and Medicaid benefits through one organization.
In the absence of a State Medicaid policy change (to require or
facilitate exclusively aligned enrollment) in Arizona, Pennsylvania, or
Virginia, our proposal would result in 12 plans losing FIDE SNP status.
However, our proposal would not prohibit those States and plans from
operating as they currently do but would simply mean that the affected
plans would be HIDE SNPs rather than FIDE SNPs beginning January 1,
2025. (A HIDE SNP is another type of D-SNP defined at Sec. 422.2 which
we describe in more detail in section II.A.5.d. of this proposed rule.)
A consequence of this would be that these plans would not qualify for
the frailty adjustment, as described in Sec. 422.308(c)(4); however,
only six of the 12 potentially-affected FIDE SNPs qualify for the
frailty adjustment in 2021 because only those six plans have a similar
average level of frailty (as determined by the Secretary) as the PACE
program. States may also choose to require, through their State
Medicaid agency contracts under Sec. 422.107, that MA organizations
create separate plan benefit packages (that is, separate D-SNPs), with
one for exclusively aligned enrollment and the other for unaligned
enrollment, the former of which would meet our proposed criteria and
allow the organization to maintain FIDE SNP status for a share of its
current FIDE SNP enrollment while using one or more new, separate D-
SNPs for the unaligned enrollment. MA organizations would need to
submit a request to CMS for a crosswalk exception under Sec.
422.530(c)(4)(i), which we are proposing in section II.A.6.a. to
redesignate from Sec. 422.530(c)(4), for such enrollment transitions.
Finally, because the definition of aligned enrollment is specific
to full-benefit dually eligible individuals, our proposal would newly
preclude partial-benefit dually eligible individuals from enrolling in
FIDE SNPs. Like with unaligned enrollees, enrollment of partial-benefit
dually eligible individuals, who receive no Medicaid benefits other
than coverage of Medicare premiums and--in some cases--Medicare cost-
sharing, precludes a D-SNP from clearly communicating the Medicaid
benefits available through the FIDE SNP or using unified appeals and
grievance procedures for adjudication of both Medicare and Medicaid
benefits. For CY 2021, however, no FIDE SNPs
[[Page 1862]]
enroll partial-benefit dually eligible individuals. As such, we do not
believe this would have any meaningful impact for plans currently
operating as FIDE SNPs. Moving forward, we believe that the benefits to
be achieved with FIDE SNPs having exclusively aligned enrollment for
Medicare beneficiaries eligible for full Medicaid benefits, as proposed
here, and the associated greater levels of integration in the provision
and coverage of benefits and plan administration outweigh the potential
negative effects for partial-benefit dually eligible individuals, who
would be limited to enrollment in HIDE SNPs, coordination-only D-SNPs,
other MA plans, or the original Medicare FFS program.
b. Capitation for Medicare Cost-Sharing for FIDE SNPs and Solicitation
of Comments for Applying to Other D-SNPs
Section 1902(a)(10)(E) of the Act directs States to pay providers
for Medicare coinsurance and deductibles for dually eligible
individuals in the Qualified Medicare Beneficiary (QMB) program. Under
section 1905(p)(3) of the Act, ``Medicare cost-sharing'' includes costs
incurred with respect to a dually eligible individual in the QMB
program,\63\ ``without regard to whether the costs incurred were for
items and services for which medical assistance [Medicaid] is otherwise
available under the plan.'' For QMBs, Medicare cost-sharing amounts
include Medicare Parts A and B premiums, coinsurance, and deductibles,
and at State option, Medicare Advantage (MA) premiums. Section
1902(n)(2) of the Act permits the State to limit payment for Medicare
cost-sharing to the amount necessary to provide a total payment to the
provider (including Medicare, Medicaid State plan payments, and third-
party payments) equal to the amount a State would have paid for the
service under the Medicaid State plan.\64\ About 8.8 million dually
eligible individuals are enrolled in the QMB program.\65\ Some States
also elect to cover all Medicare cost-sharing for Medicare
beneficiaries eligible for full Medicaid benefits who are not QMBs.
This election means the State pays Medicare cost-sharing for a non-QMB
full-benefit dually eligible individual even if the Medicare service is
not covered under the Medicaid State plan. Absent such an election by
the State, the State would pay the Medicare cost-sharing for non-QMB
full-benefit dually eligible individual only if the Medicare service,
such as inpatient hospitalization, is also covered under the Medicaid
State plan. \66\ Typically, States allow FIDE SNP enrollment of both
QMB and non-QMB full-benefit dually eligible individuals.
---------------------------------------------------------------------------
\63\ Under 1905(p)(1) of the Act, a QMB is an individual who is
entitled to hospital insurance benefits under Part A of Medicare,
with income not exceeding 100 percent of the Federal poverty level,
and resources not exceeding three times the SSI limit, adjusted
annually by the Consumer Price Index. For more information about QMB
eligibility and benefits, see chapter 1, section 1.6.2.1 and
Appendices 1.A and 1.B of the Manual for the State Payment of
Medicare Premiums, found here: <a href="https://www.cms.gov/files/document/chapter-1-program-overview-and-policy.pdf">https://www.cms.gov/files/document/chapter-1-program-overview-and-policy.pdf</a>.
\64\ For example, if the Medicare (or MA) rate for a service is
$100, of which $20 is beneficiary coinsurance, and the Medicaid rate
for the service is $90, the State would only pay $10. If the
Medicaid rate is $80 or lower, the State would make no payment. This
is often referred to as the ``lesser of'' policy. Under the ``lesser
of'' policy, a State caps its payment of Medicare cost-sharing at
the Medicaid rate for a particular service.
\65\ CMS Medicare-Medicaid Coordination Office, ``Data Analysis
Brief: Medicare-Medicaid Dual Eligible Enrollment: 2006-2019''.
Retrieved from: <a href="https://www.cms.gov/files/document/medicaremedicaiddualenrollmenteverenrolledtrendsdatabrief.pdf">https://www.cms.gov/files/document/medicaremedicaiddualenrollmenteverenrolledtrendsdatabrief.pdf</a>.
\66\ See Chapter II, sections E.4 through E.6 of the Medicaid
Third Party Liability Handbook at <a href="https://www.medicaid.gov/medicaid/eligibility/downloads/cob-tpl-handbook.pdf">https://www.medicaid.gov/medicaid/eligibility/downloads/cob-tpl-handbook.pdf</a>.
---------------------------------------------------------------------------
CMS automatically forwards claims under the original Medicare FFS
program to State Medicaid agencies and other secondary payers to
adjudicate the claims for payment of any Medicare cost-sharing.\67\
This automatic claims crossover process greatly reduces provider burden
by eliminating the need for providers to submit separate claims to both
Medicare and the State Medicaid agency, or a Medicaid managed care
plan, such as a Medicaid MCO, prepaid inpatient health plan (PIHP), or
prepaid ambulatory health plan (PAHP), as defined at Sec. 438.2, for
payment of Medicare cost-sharing when it is covered by Medicaid. For
providers serving dually eligible individuals enrolled in MA plans,
including FIDE SNPs, HIDE SNPs, and other D-SNPs, there is no guarantee
of an automated crossover process to State Medicaid agencies or
Medicaid managed care plans to process Medicaid payment of Medicare
cost-sharing. This means the providers must submit claims to the MA
plan, then determine the responsible State Medicaid agency or Medicaid
managed care plan, and then submit another claim to the State Medicaid
agency or Medicaid managed care plan for adjudication of the claims for
Medicare cost-sharing.
---------------------------------------------------------------------------
\67\ State Medicaid agencies and Medicaid managed care plans
enter into a Coordination of Benefits Agreement (COBA) for the
purpose of coordinating health insurance benefits and facilitating
the proper payment of claims for beneficiaries enrolled in the
original Medicare FFS program. Within the COBA, State Medicaid
agencies and Medicaid managed care plans elect which COBA claims for
CMS to transfer. For more information, see: <a href="https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/COBA-Trading-Partners/Coordination-of-Benefits-Agreements/Coordination-of-Benefits-Agreement-page">https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/COBA-Trading-Partners/Coordination-of-Benefits-Agreements/Coordination-of-Benefits-Agreement-page</a>.
---------------------------------------------------------------------------
One way to alleviate provider burden and streamline claims
processing is for the State Medicaid agency to make a capitated payment
for Medicaid coverage of Medicare cost-sharing to the MA plan in which
a dually eligible individual (specifically, a QMB or other dually
eligible individual for which the State covers Medicare cost-sharing)
is enrolled. When the State contract with the MA plan includes
capitated payment for Medicaid coverage of Medicare cost-sharing, the
provider submits one claim to the MA plan, and the MA plan adjudicates
the claim for Medicare coverage of services and for Medicaid payment of
Medicare cost-sharing without the provider submitting separate claims
to the MA plan and the proper Medicaid entity (that is, State Medicaid
agency or Medicaid managed care plan). Additionally, this arrangement
reduces other potential obstacles, including determining the proper
Medicaid entity to bill for Medicare cost-sharing, determining a
beneficiary's applicable coverage of Medicare cost-sharing (for
example, in States that pay Medicare cost-sharing for Medicare
beneficiaries eligible for full Medicaid benefits who are not QMBs),
and the potential for improper QMB billing.
We propose to specify in Sec. 422.2 that FIDE SNPs are required to
cover Medicare cost- sharing as defined in section 1905(p)(3)(B), (C)
and (D) of the Act, without regard to how section 1905(n) limits that
definition to QMBs, as part of the FIDE SNP's coverage of primary and
acute care; this means that the proposed amendment would require FIDE
SNPs to cover Medicare cost -sharing for both QMB and non-QMB full-
benefit dually eligible FIDE SNP enrollees. We intend this revision to
encompass all cost-sharing, whether it is in the form of coinsurance,
copayments, or deductibles, for Medicare Part A and Part B benefits
covered by the D-SNP. The current definition of a FIDE SNP at Sec.
422.2 requires a FIDE SNP's capitated contract with the State Medicaid
agency to provide coverage, consistent with State policy, of specified
primary care, acute care, behavioral health, and LTSS, and provide
coverage of nursing facility services for a period of at least 180 days
during the plan year. Medicare covers most primary care and acute care
services and Medicare is always the primary payer for any Medicare-
covered services with Medicaid covering any Medicare cost-sharing in
such cases.
[[Page 1863]]
Under this proposal, a FIDE SNP would cover Medicare payment for
primary care and acute care covered by Medicare and the Medicaid
payment for any Medicare cost-sharing in such cases. In plan year 2021,
all 69 FIDE SNPs include Medicare cost-sharing in their capitated
contracts with the State Medicaid agency.\68\ Therefore, we do not
expect our proposal to have any impact on existing FIDE SNPs.
---------------------------------------------------------------------------
\68\ CMS Special Needs Plan Comprehensive Report, January 2021:
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-
Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-
Data#:~:text=Special%20Needs%20Plan%20%28SNP%29%20Data%20%20%20,%20%2
02021-03%20%206%20more%20rows%20.
---------------------------------------------------------------------------
We chose to propose this change only for FIDE SNPs because FIDE
SNPs are the only type of D-SNP that must cover Medicaid acute and
primary care benefits and are better equipped, compared to other D-
SNPs, to make improvements for coordination of benefits and
adjudication of claims. This is especially true when capitation for
Medicare cost-sharing is combined with a requirement for exclusively
aligned enrollment (as proposed in section II.A.5.a. of this proposed
rule to amend the FIDE SNP definition at Sec. 422.2). Under our
proposal, a provider serving a dually eligible individual enrolled in a
FIDE SNP with exclusively aligned enrollment would submit a single
claim to the FIDE SNP for both Medicare and Medicaid coverage of the
service; the FIDE SNP would adjudicate the claim for a covered service
for any applicable Medicare payment, Medicaid payment, and Medicaid
payment of Medicare cost-sharing. In this way, the proposed additions
to the definition of FIDE SNPs at Sec. 422.2 would ensure that all
FIDE SNPs include elements--capitation for Medicare cost-sharing and
exclusively aligned enrollment--that result in improved beneficiary and
provider experiences. This proposal furthers the level of integration
required for FIDE SNPs in a way that we believe would achieve those
improved experiences. In other types of D-SNPs, such as HIDE SNPs,
members may participate in the HIDE SNP for their Medicare benefits and
an unaffiliated Medicaid managed care plan or the State Medicaid FFS
program for their Medicaid acute and primary care benefits. When
Medicare and Medicaid plan enrollment is unaligned, as it is in many
HIDE SNPs, a provider serving a dually eligible individual enrolled in
a HIDE SNP would submit a claim to the HIDE SNP for Medicare payment of
the service, then submit a second claim to the Medicaid managed care
plan or the State Medicaid program for Medicaid payment of the covered
benefit.
Our proposal does not include Medicare Parts A and B premiums in
the requirement for FIDE SNPs to cover Medicare cost-sharing. We do not
believe that it is necessary to require FIDE SNPs (or other D-SNPs) to
pay premiums as there is a loss of efficiency and no additional
integration of benefits to be achieved by having a State pay a
capitation rate to an MA organization for the MA organization to cover
Medicare premiums. The State Medicaid agency will continue to pay the
Medicare Parts A and B premiums on behalf of dually eligible
beneficiaries in accordance with Sec. Sec. 406.26 and 406.32(g) and
part 407, subpart C, of the chapter. Therefore, we propose to
specifically exclude payment of Medicare premiums as a coverage
requirement for dually eligible beneficiaries enrolled in FIDE SNPs.
In addition to our proposal for FIDE SNPs, we encourage States to
include Medicaid coverage of Medicare Part A and Part B cost-sharing
(other than Medicare premiums) for dually eligible individuals in their
capitated contracts with all D-SNPs as a method of reducing provider
burden and improving access. We considered proposing a requirement that
all D-SNPs have a contract with States for capitation for Medicare
cost-sharing. Unlike FIDE SNPs with our proposed requirement for
exclusively aligned enrollment, applying a requirement to other D-SNPs
raises a number of complicating, but we believe solvable, problems. In
States that have capitated payment arrangements with Medicaid managed
care plans to cover Medicaid primary and acute services and behavioral
health, such coverage typically requires the Medicaid managed care plan
to cover Medicare cost-sharing when Medicare covers the service. That
means, when enrollment is not aligned between a D-SNP and the Medicaid
managed care plan, the result is not a streamlined payment process for
the provider. A contract with the D-SNP for capitated coverage of
Medicare cost-sharing--and a carve-out of Medicare cost-sharing
coverage from the Medicaid managed care contract--can put Medicare
coverage of services and Medicaid coverage of Medicare cost-sharing
under a single entity, but could be a complicated process for States to
implement. For States without Medicaid managed care programs for dually
eligible individuals, contracting (with capitation payments) with D-
SNPs for coverage of Medicare cost-sharing can be a more
straightforward process. We solicit feedback on the feasibility,
implementation, estimated time to enact, and impact of requiring
capitated Medicare cost-sharing for all D-SNPs to inform future
rulemaking.
In the CY 2020 Medicare Parts C and D Draft Call Letter, we
requested comments on the ways to extend the benefits of the automatic
claims crossover process for services provided to dually eligible
individuals in MA plans and discussed those comments in the CY 2020
Medicare Parts C and D Final Call Letter.\69\ Commenters described the
need for MA plans to have real-time Medicaid eligibility and enrollment
data to facilitate better coordination of care and Medicare cost-
sharing payment across MA plans and Medicaid MCOs. Therefore, we also
considered proposing a requirement for States to provide real-time
Medicaid managed care plan enrollment data to D-SNPs to enable better
coordination between the D-SNP and the State and/or Medicaid managed
care plan. We chose not to propose a requirement at this time to allow
more time for us to consider the operational challenges for States. We
solicit feedback on the pros and cons of requiring State Medicaid data
exchanges to provide real-time Medicaid FFS program and Medicaid
managed care plan enrollment data with D-SNPs, and the impact of such a
requirement on States, Medicaid managed care plans, D-SNPs, providers,
and beneficiaries.
---------------------------------------------------------------------------
\69\ CMS, Announcement of Calendar Year (CY) 2020 Medicare
Advantage Capitation Rates and Medicare Advantage and Part D Payment
Policies and Final Call Letter, April 1, 2019. Retrieved from:
<a href="https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf">https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf</a>.
---------------------------------------------------------------------------
c. Scope of Services Covered by FIDE SNPs
(1) Need for Clarification of Medicaid Services Covered by FIDE SNPs
CMS first defined the term ``fully integrated dual eligible special
needs plan'', or FIDE SNP, at Sec. 422.2 in the ``Medicare Program;
Changes to the Medicare Advantage and the Medicare Prescription Drug
Benefit Programs for Contract Year 2012 and Other Changes'' final rule
(76 FR 21432) (hereinafter referred to as the April 2011 final rule) to
implement section 3205(b) of the Affordable Care Act (which amended
section 1853(a)(1)(B)(vi) of the Act to add a frailty adjustment to the
risk adjustment payments for certain FIDE SNPs). That definition
provided that a FIDE SNP must have a capitated contract with a State
Medicaid agency that includes coverage of specified primary, acute, and
long-term care
[[Page 1864]]
benefits and services, consistent with State policy. We explained then
that the term ``consistent with State policy'' recognizes the
variability in the degree and extent to which Medicaid services are
covered from one State to the next (76 FR 21444). Section 1859(f)(3)(D)
of the Act, as added by section 164(c)(3)(D) of MIPPA, uses the phrase
``consistent with State policy'' to describe the Medicaid long-term
care services that the D-SNP may include in its contract with the State
Medicaid agency. As used in the definition of FIDE SNP, the term
``specifies'' acknowledges that States vary in the degree in which
Medicaid services are covered by the State under its Medicaid program
(encompassing the Medicaid State plan and any waivers) by only
requiring the FIDE SNP to cover those services specified by the State
Medicaid agency as covered in its Medicaid program. Further, in the
April 2011 final rule (76 FR 21444), we explained that the FIDE SNP
definition at Sec. 422.2 requires the plan to provide all Medicaid-
covered primary, acute, and long-term care services and supports (LTSS)
to beneficiaries, and not some combination thereof.
Despite this discussion in the 2011 final rule that FIDE SNPs would
provide all primary, acute, and long-term care services and benefits
covered by the State Medicaid program, we did not operationalize review
of State Medicaid agency contracts in that way. CMS determined D-SNPs
to be FIDE SNPs even where the State carved out certain primary care,
acute care, and LTSS benefits from the Medicaid coverage required from
the D-SNP. In effect, we allowed States flexibility in the coverage
provided by FIDE SNPs, not only to accommodate differences in the
benefits covered under various State Medicaid programs but to
accommodate differences in State contracting strategies for managed
care broadly, and for FIDE SNPs in particular. In the April 2019 final
rule (84 FR 15706 through 15707), we revised the FIDE SNP definition at
Sec. 422.2 to add Medicaid behavioral health services to the list of
services that a FIDE SNP must include in its capitated contract with
the State Medicaid agency. But, consistent with how we were
operationalizing this definition, we explained that our amendment would
allow plans to meet the FIDE SNP definition even where the State
excluded Medicaid behavioral health services from the capitated
contract.
The way we have applied the definition of FIDE SNPs has not enabled
us to ensure FIDE SNPs fully integrate Medicare and Medicaid services
for dually eligible individuals, which was the goal of the April 2011
final rule. We propose to revise paragraph (2) of the definition of a
FIDE SNP at Sec. 422.2 to clearly specify which services and benefits
must be covered under the FIDE SNP capitated contract with the State
Medicaid agency, and thus bring fuller integration of Medicaid benefits
to individuals enrolled in FIDE SNPs. Our proposal would revise
paragraph (2) of the existing definition into paragraphs (2)(i) through
(v), with each of the new paragraphs addressing specific coverage
requirements. We believe the proposed requirements described in this
section strike the appropriate balance between flexibility for
variations in State Medicaid policy and our goal of achieving full
integration in FIDE SNPs. In addition, as discussed more fully in
section II.A.5.e., our proposed revision of the definition, in
conjunction with a proposal to add Sec. 422.107(g) and (h), includes
flexibility for approval of some limited carve-outs of LTSS and
behavioral health services.
(2) Requiring FIDE SNPs To Cover All Medicaid Primary and Acute Care
Benefits
Primary and acute care benefits for dually eligible beneficiaries
are generally covered by Medicare as the primary payer rather than
Medicaid. We propose revisions to the FIDE SNP definition in paragraph
(2)(i) of Sec. 422.2 to limit the FIDE SNP designation to D-SNPs that
cover all primary care and acute care services and Medicare cost-
sharing--to the extent such benefits are covered for dually eligible
individuals in the State Medicaid program--through their capitated
contracts with State Medicaid agencies. Our proposal here means that
all primary and acute care services, including the Medicare cost-
sharing covered by the State Medicaid program (as discussed earlier in
section II.A.5.b. of this proposed rule) must be covered by the FIDE
SNP under the MCO contract between the State and the organization that
offers the FIDE SNP and the MCO. We seek comment on whether we should
allow for specific carve-outs of some of these benefits and services.
We welcome specific examples of primary and acute care benefits that
are either currently carved out of FIDE SNP capitated contracts with
State Medicaid agencies or should be carved out and request that
comments include the reason for the existing and proposed future carve-
outs.
We are clarifying here that Medicaid non-emergency medical
transportation (NEMT) as defined in Sec. 431.53 is not a primary or
acute care service included in the scope of this provision. We
recognize that Medicaid NEMT is a critical service for dually eligible
individuals to access primary and acute care services. However, we do
not consider NEMT coverage to be required for FIDE SNPs under the
current or proposed definition. We note that States are able to
contract with their D-SNPs, or the affiliated Medicaid managed care
plans, to cover NEMT. Such contracting might provide these plans with
useful tools to facilitate access to care for their members and make it
easier for States to coordinate Medicaid NEMT with overlapping services
provided by D-SNPs as Medicare supplemental benefits.
(3) Requiring FIDE SNPs To Cover Medicaid Home Health and Durable
Medical Equipment
We propose to require that, effective beginning in 2025, each FIDE
SNP must cover additional Medicaid benefits to the full extent that
those benefits are covered by the State Medicaid program. Those
benefits we are proposing to add are home health services, as defined
in Sec. 440.70, and durable medical equipment (DME) services, as
defined in Sec. 440.70(b)(3). We believe that FIDE SNPs should be
required to cover the Medicaid home health and DME benefits because
home health and DME are critical services for dually eligible
individuals, necessitate coordination due to being covered by both the
Medicare and Medicaid programs, and are not clearly captured under
other parts of the existing definition. Based on our review of State
coverage requirements for Medicaid MCOs affiliated with FIDE SNPs, all
current FIDE SNPs already cover Medicaid home health services and DME,
so we do not expect this proposal to impact any existing FIDE SNPs.
However, we propose that this change in the scope of required coverage
by FIDE SNPs would not apply until 2025 in case there are other
circumstances of which we are not aware that would necessitate
additional time to adapt to our proposal.
As such, we propose to add a new paragraph (2)(iv) of the FIDE SNP
definition at Sec. 422.2 related to scope of services to clarify that
a FIDE SNP's capitated contract with the State Medicaid agency must
include all Medicaid home health services as defined at Sec. 440.70.
Also, we propose to add a new paragraph (2)(v) of the FIDE SNP
definition at Sec. 422.2 related to scope of services to clarify that
a FIDE SNP's capitated contract with the State Medicaid agency must
include all Medicaid DME as defined at Sec. 440.70(b)(3).
[[Page 1865]]
(4) Requiring FIDE SNPs To Cover Medicaid Behavioral Health Services
Behavioral health needs are extensive among dually eligible
individuals. Nearly one-third of individuals who are dually eligible
for Medicare and Medicaid have been diagnosed with a serious mental
illness, such as schizophrenia, bipolar disorder, or major depressive
disorder, a rate almost three times higher than for non-dually eligible
Medicare beneficiaries.\70\ Full-benefit dually eligible individuals
experience higher rates of bipolar disorder and are more likely to use
at least one Medicare or Medicaid community mental health service than
partial benefit dually eligible individuals.\71\ Fragmented physical
and behavioral health care, delivered across multiple providers and
funding sources, can decrease access to care and lead to poor health
status.\72\ Some studies, such as the ``Improving Mood--Promoting
Access to Collaborative Treatment for Late-Life Depression'' study,
provide evidence that coordinated medical and behavioral health care
lead to better behavioral health outcomes.\73\
---------------------------------------------------------------------------
\70\ Congressional Budget Office. ``Dual-Eligible Beneficiaries
of Medicare and Medicaid: Characteristics, Health Care Spending, and
Evolving Policies.'' (June 2013). Retrieved from: <a href="https://www.cbo.gov/sites/default/files/113th-congress-2013-2014/reports/44308dualeligibles2.pdf">https://www.cbo.gov/sites/default/files/113th-congress-2013-2014/reports/44308dualeligibles2.pdf</a>. This report classified Medicare enrollees
as having a mental illness if they had a diagnosis from the previous
year of schizophrenia; major depressive, bipolar, and paranoid
disorders; or other major psychiatric disorders.
\71\ Integrated Care Resources Center, Working With Medicare
Webinar, <a href="https://www.integratedcareresourcecenter.com/sites/default/files/4.15.20%20WWM%20BH%20Slide%20Deck_for%20508%20Review.pdf">https://www.integratedcareresourcecenter.com/sites/default/files/4.15.20%20WWM%20BH%20Slide%20Deck_for%20508%20Review.pdf</a>.
\72\ Medicaid and CHIP Payment and Access Commission.
``Integration of Behavioral and Physical Health Services in
Medicaid.'' March 2016. Available at: <a href="https://www.macpac.gov/wp-content/uploads/2016/03/Integration-of-Behavioral-and-Physical-Health-Services-in-Medicaid.pdf">https://www.macpac.gov/wp-content/uploads/2016/03/Integration-of-Behavioral-and-Physical-Health-Services-in-Medicaid.pdf</a>.
\73\ Unutzer, et al., Journal of the American Medical
Association, ``Collaborative Care Management of Late-life Depression
in the Primary Care Setting: A Randomized Controlled Trial'',
December 11, 2002. Available at: <a href="https://aims.uw.edu/resource-library/collaborative-care-management-late-life-depression-primary-care-setting-randomized">https://aims.uw.edu/resource-library/collaborative-care-management-late-life-depression-primary-care-setting-randomized</a>.
---------------------------------------------------------------------------
We explained earlier in this section that, consistent with how we
were operationalizing the FIDE SNP definition since first adopting it
at Sec. 422.2 as established in the April 2011 final rule, we have
allowed plans to meet the FIDE SNP definition even where a State
excluded Medicaid behavioral health services from the capitated
contract with the State Medicaid agency. In the April 2019 final rule,
we added behavioral health services to the list of benefits that a D-
SNP must cover, consistent with State policy, to obtain the FIDE SNP
designation. We stated that complete carve out of behavioral health by
a State from the scope of the Medicaid coverage provided by a FIDE SNP
would be permissible (84 FR 15706-15707). We believe that a revision to
that policy is appropriate and propose to establish in a new paragraph
(2)(iii) in the FIDE SNP definition at Sec. 422.2 requiring that, for
2025 and subsequent years, the capitated contract with the State
Medicaid agency must include coverage of Medicaid behavioral health
services. This proposal would require the Medicaid MCO that is offered
by the same entity offering the FIDE SNP to cover all behavioral health
services covered by the State Medicaid program for the enrollees in the
FIDE SNP. Our proposal to require FIDE SNPs to cover Medicaid
behavioral health services is consistent with sections
1853(a)(1)(B)(iv) and 1859(f)(8)(D)(i)(II) of the Act. We propose the
2025 date to allow time for MA organizations and States to adapt to our
proposal.
Restricting FIDE SNP designation to plans capitated for Medicaid
behavioral health services, as well as other benefits, has two
advantages. First, it better comports with a common understanding of
being ``fully integrated''--the term used in sections 1853(a)(1)(B)(iv)
and 1859(f)(8)(D)(i)(II) of the Act--because of the importance of
behavioral health services for dually eligible individuals. Absent
coverage of Medicaid behavioral health services, a FIDE SNP would be
less able to effectively coordinate overlapping behavioral health
services covered by Medicare and Medicaid and would have an incentive
to steer beneficiaries toward Medicaid-covered services for which it is
not financially responsible. Coverage of Medicaid behavioral health
services also facilitates integrating behavioral health and physical
health services, which can result in improved outcomes for dually
eligible beneficiaries.\74\ In addition, our proposal would more
clearly distinguish a FIDE SNP--which would have to cover both LTSS and
behavioral health services--from a HIDE SNP--which must cover either
LTSS or behavioral health services. This would reduce confusion among
stakeholders.
---------------------------------------------------------------------------
\74\ Unutzer, et al., Journal of the American Medical
Association, ``Collaborative Care Management of Late-life Depression
in the Primary Care Setting: A Randomized Controlled Trial'',
December 11, 2002. Available at: <a href="https://aims.uw.edu/resource-library/collaborative-care-management-late-life-depression-primary-care-setting-randomized">https://aims.uw.edu/resource-library/collaborative-care-management-late-life-depression-primary-care-setting-randomized</a>.
---------------------------------------------------------------------------
Since codifying the definition of HIDE SNP in the April 2019 final
rule, we have received many questions from MA organizations and other
stakeholders about the difference between a FIDE SNP and HIDE SNP, and
we attempted to further explain the distinction in a January 17, 2020
Health Plan Management System memorandum titled, ``Additional Guidance
on CY 2021 Medicare-Medicaid Integration Requirements for Dual Eligible
Special Needs Plans'' (January 2020 memorandum).\75\ Requiring a FIDE
SNP to include Medicaid behavioral health services, with the exception
of limited carve-outs as proposed at Sec. 422.107(h) and described in
section II.A.5.e., would make the coordination continuum from HIDE SNP
to FIDE SNP easier to explain and understand since HIDE SNP designation
would allow for a carve-out in full or in part of either Medicaid
behavioral health services or LTSS while FIDE SNP designation would
allow for only limited carve-outs of Medicaid behavioral health
services (or, as discussed in section II.A.5.e., of LTSS). As proposed,
Sec. 422.107(h) would permit limited exclusions from coverage of
Medicaid behavioral health services by both FIDE SNPs and HIDE SNPs
while treating those plans as providing coverage of the category of
benefits. Under the proposal, the permissible carve-outs would be
limited to a minority of beneficiaries eligible to enroll in the D-SNP
and use Medicaid behavioral health services or constitute a small part
of the total scope of behavioral health services for which Medicaid is
generally the primary payer. Thus, under our proposal, FIDE SNPs would
cover the vast majority of Medicaid behavioral health benefits and
Medicaid LTSS benefits, and HIDE SNPs would cover the vast majority of
Medicaid behavioral health benefits or Medicaid LTSS benefits (or
potentially both categories of benefits).
---------------------------------------------------------------------------
\75\ CMS Medicare-Medicaid Coordination Office, ``Additional
Guidance on CY 2021 Medicare-Medicaid Integration Requirements for
Dual Eligible Special Needs Plans'', January 17, 2020. Retrieved
from: <a href="https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-5">https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-5</a>.
---------------------------------------------------------------------------
Most FIDE SNPs already have contracts with States to cover Medicaid
behavioral health benefits, indicating that the market has already
moved in this direction and relatively few FIDE SNPs would be impacted
by our proposal. Our review of State Medicaid agency contracts for FIDE
SNPs in CY 2021 indicates that States include full coverage of Medicaid
behavioral health services for 45 of the 69 FIDE SNPs.\76\ The FIDE
SNPs with contracts that carve
[[Page 1866]]
out Medicaid behavioral health include two FIDE SNPs in California, 17
FIDE SNPs in New York, and five FIDE SNPs in Pennsylvania.\77\ Based on
a New York State Medicaid policy change, we expect FIDE SNPs in New
York to cover Medicaid behavioral health services, effective January 1,
2023, so we do not anticipate our proposal will negatively impact FIDE
SNPs in New York.\78\ If the remaining FIDE SNPs in California and
Pennsylvania do not meet the proposed FIDE SNP definition at Sec.
422.2, they may still meet the HIDE SNP definition proposed at Sec.
422.2. We believe the benefit of restricting FIDE SNP designation to
plans that cover Medicaid behavioral health services in the capitated
contract with the State Medicaid agency outweighs the benefit of
continuing to allow FIDE SNP designation for plans that do not cover
these benefits.
---------------------------------------------------------------------------
\76\ CMS review of CY 2021 State Medicaid agency contracts for
FIDE SNPs.
\77\ See <a href="https://www.cms.gov/files/document/smacdsnpintegrationstatusesdata.xlsx">https://www.cms.gov/files/document/smacdsnpintegrationstatusesdata.xlsx</a>.
\78\ New York State Department of Health, New York State Office
of Mental Health, and New York State Office of Alcoholism and
Substance Abuse Services, ``Duals Integration: Adding Behavioral
Health Services into Medicaid Advantage Plus,'' December 2020.
---------------------------------------------------------------------------
Increasing the minimum scope of services that FIDE SNPs must cover
in an integrated fashion is consistent with how section 1859(f)(8)(D)
of the Act identifies Medicaid LTSS and behavioral health services as
key areas for the integration of services. While the statute generally
describes the increased level of integration that is required by
referring to coverage of behavioral health or LTSS or both, we believe
that exceeding that minimum standard is an appropriate goal for FIDE
SNPs. The most integrated D-SNPs--FIDE SNPs--should cover the broadest
array of Medicaid-covered services, including the behavioral health
treatment and LTSS that are so important to the dually eligible
population.
Further, increasing the minimum scope of services for FIDE SNPs is
not inconsistent with section 1853(a)(1)(B)(iv) of the Act, which
states that such plans are fully integrated with capitated contracts
with States for Medicaid benefits, including LTSS. While section
1853(a)(1)(B)(iv) does not specify coverage of behavioral health
services, it does not exclude coverage of behavioral health services
either given that the section speaks generally to FIDE SNPs having
fully integrated contracts with States for Medicaid benefits. As
discussed earlier in this section, behavioral health services are
critical for dually eligible individuals and benefit from coordination
with Medicare services and, we believe, coverage of Medicaid behavioral
health benefits by a D-SNP is key to achieving fully integrated status.
Specifically, we propose the following changes at paragraph (2) of
the FIDE SNP definition at Sec. 422.2 related to scope of services:
<bullet> Strike the words ``provides coverage consistent with State
policy of'' and replace them with ``requires coverage of the following
benefits, to the extent Medicaid coverage of such benefits is available
to individuals eligible to enroll in a FIDE SNP in the State, except as
approved by CMS under Sec. 422.107(g) and (h)'' to clarify the
services the FIDE SNP must include in its capitated contract with the
State Medicaid agency;
<bullet> Redesignate to a new paragraph (2)(i) the requirement that
a FIDE SNP's capitated contract with the State Medicaid agency must
include all primary care and acute care covered under the State
Medicaid program, and newly specify that these contracts must include
Medicare cost-sharing as defined in section 1905(p)(3)(B), (C), and (D)
of the Act, without regard to the limitation of that definition to
qualified Medicare beneficiaries;
<bullet> Redesignate to a new paragraph (2)(ii) the requirement
that a FIDE SNP's capitated contract with the State Medicaid agency
include all LTSS covered under State Medicaid policy, including
coverage of nursing facility services for a period of at least 180 days
during the plan year;
<bullet> Add new paragraph (2)(iii) to require that a FIDE SNP's
capitated contract with the State Medicaid agency must include Medicaid
behavioral health services for plan year 2025 and subsequent years;
<bullet> Add new paragraph (2)(iv) to require that a FIDE SNP's
capitated contract with the State Medicaid agency must include all
Medicaid home health services as defined at Sec. 440.70 for plan year
2025 and subsequent years; and
<bullet> Add new paragraph (2)(v) to require that a FIDE SNP's
capitated contract with the State Medicaid agency must include all
Medicaid DME as defined at Sec. 440.70(b)(3) for plan year 2025 and
subsequent years.
d. Clarification of Coverage of Certain Medicaid Services by HIDE SNPs
CMS first defined the term ``highly integrated dual eligible
special needs plan'', or HIDE SNP, at Sec. 422.2 in the April 2019
final rule. As currently defined at Sec. 422.2, a HIDE SNP is a type
of D-SNP offered by an MA organization that has--or whose parent
organization or another entity that is owned and controlled by its
parent organization has--a capitated contract with the Medicaid agency
in the State in which the D-SNP operates that includes coverage of
Medicaid LTSS, Medicaid behavioral health services, or both, consistent
with State policy. As stated in the April 2019 final rule (84 FR
15705), the HIDE SNP designation is consistent with section
1859(f)(8)(D)(i)(II) of the Act that recognizes a level of integration
that does not meet the requirements of the FIDE SNP with respect to the
breadth of services provided under a Medicaid capitated contract with
the State.
We propose to update the HIDE SNP definition at Sec. 422.2
consistent with proposed changes to the FIDE SNP definition described
earlier in section II.A.5.c. of this proposed rule to more clearly
outline the services HIDE SNPs must include in their contracts with
State Medicaid agencies. Similar to our proposal for the revised FIDE
SNP definition, we propose to move away from the current use of
``coverage, consistent with State policy'' language in favor of more
clearly articulating the minimum scope of Medicaid services that must
be covered by a HIDE SNP. Specifically, we propose the following at
paragraph (2) of the HIDE SNP definition at Sec. 422.2:
<bullet> Strike the words ``consistent with State policy, of long-
term services and supports, behavioral health services, or both'' and
instead require a HIDE SNP to have a capitated contract with the State
Medicaid agency that requires the HIDE SNP to cover, at a minimum,
Medicaid long-term services and supports or Medicaid behavioral health
services;
<bullet> Reorganize paragraphs (1) and (2) into paragraphs (1)(i)
and (ii) to outline that the capitated contract is between the State
Medicaid agency and the MA organization or between the State Medicaid
agency and the MA organization's parent organization, or another entity
that is owned and controlled by its parent organization;
<bullet> Redesignate paragraph (2) into paragraphs (2)(i) and (ii)
to state that the capitated contract requires coverage of LTSS,
including community-based LTSS and some days of coverage of nursing
facility services during the plan year, or behavioral health services
to the extent Medicaid coverage of such services is available to
individuals eligible to enroll in a HIDE SNP in the State; and
<bullet> To redesignated paragraph (2), add the words ``except as
approved by CMS under Sec. 422.107(g) or (h)'' such that the HIDE SNP
``requires coverage of the following benefits, to the extent Medicaid
coverage of such benefits is
[[Page 1867]]
available to individuals eligible to enroll in a HIDE SNP in the State,
except as approved by CMS under Sec. 422.107(g) or (h),'' to clarify
that the HIDE SNP must cover under its capitated Medicaid contract the
full scope of the Medicaid benefit for the specified LTSS or Medicaid
behavioral health services, except for limited carve-outs that CMS
permits under proposed Sec. 422.107(g) or (h); and
<bullet> Add new paragraph (3) to require that the capitated
Medicaid contract applies in the entire service area of the D-SNP for
plan year 2025 and subsequent plan years.
Later in this section, we describe in more detail our proposal to
require the capitated contract applies in the entire service area for
the D-SNP. Otherwise, our proposal is generally a reorganization and
clarification of the scope of Medicaid benefits that must be covered by
a HIDE SNP.
e. Medicaid Carve-Outs and FIDE SNP and HIDE SNP Status
As discussed earlier, we propose to require FIDE SNPs and HIDE SNPs
to cover the full scope of the Medicaid coverage under the State
Medicaid program of the categories of services that are specified as
minimum requirements for these plans as outlined in sections II.A.5.c.
and II.A.5.d. In both definitions, we propose that coverage of the full
scope of the specified categories of Medicaid benefits is subject to an
exception that may be permitted by CMS under Sec. 422.107(g) or (h).
We propose to codify at Sec. 422.107(g) and (h), respectively, current
CMS policy allowing limited carve-outs from the scope of Medicaid LTSS
and Medicaid behavioral health services that must be covered by FIDE
SNPs and HIDE SNPs. As discussed in section II.A.5.c.1. of this
proposed rule, CMS has historically determined D-SNPs to be FIDE SNPs
even where the State carved out certain primary care, acute care, LTSS,
and behavioral health services from the Medicaid coverage furnished by
the MCO offered by the FIDE SNP. CMS has similarly permitted carve-outs
of the scope of Medicaid coverage furnished in connection with HIDE
SNPs. We believe that codifying these policies would improve
transparency for stakeholders and allow us to better enforce our
policies to limit benefit carve-outs.
Our proposal is consistent with the policy described in a
memorandum CMS issued in January 2020,\79\ with some revisions to
improve clarity and avoid misinterpretations of our policy that might
result from language in the memorandum that differs in the allowed
carve-outs for LTSS and behavioral health services. Like the
memorandum, our proposal is designed to accommodate differences in
State Medicaid policy--for example, the desire to retain delivery
through the Medicaid FFS program of specific waiver services applicable
to a small, specified population, or to retain coverage in the Medicaid
FFS program for specific providers--without significantly undermining
the level of Medicaid integration provided by HIDE SNPs and FIDE SNPs.
While we generally favor integration and worry that Medicaid benefit
carve-outs work against integration, we believe our proposal strikes a
balance between the current realities of State managed care policy,
applicable statutory provisions, and our implementation of those
statutory provisions toward the goal of raising the bar on integration.
---------------------------------------------------------------------------
\79\ CMS, ``Additional Guidance on CY 2021 Medicare-Medicaid
Integration Requirements for Dual Eligible Special Needs Plans'',
January 17, 2020. Retrieved from: <a href="https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-5">https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-5</a>.
---------------------------------------------------------------------------
Currently and under our proposal to revise the definition, a D-SNP
may meet the criteria for designation as a HIDE SNP if it covers either
Medicaid LTSS or Medicaid behavioral health services under a State
Medicaid agency contract. The Medicaid contract may be between the
State and either the legal entity providing the D-SNP, the parent
organization of the D-SNP, or a subsidiary owned or controlled by the
parent organization of the D-SNP. As discussed in the April 2019 final
rule (84 FR 15705), the breadth of Medicaid LTSS coverage under a HIDE
SNP does not have to be as broad as the coverage of Medicaid benefits
provided by a FIDE SNP. For example, a HIDE SNP is not required to
provide at least 180 days of nursing facility coverage during the plan
year. If the HIDE SNP designation is based on coverage of Medicaid
LTSS, such capitated coverage must include both of the following:
Community-based LTSS, subject to permissible carve-outs, and
institutional LTSS. Institutional LTSS must include coverage of nursing
facility services with some days for which Medicaid coverage is primary
but, in contrast to a FIDE SNP, may be less than 180 days each plan
year. However, if a HIDE SNP designation is based on coverage of
Medicaid behavioral health services, the HIDE SNP can cover some
community-based and/or institutional LTSS or no LTSS.
We currently grant FIDE SNP status despite Medicaid LTSS carve-outs
of limited scope if such carved-out services (1) apply to a minority of
the full-benefit dually eligible LTSS users eligible to enroll in the
FIDE SNP who use long-term services and supports or (2) constitute a
small part of the total scope of Medicaid LTSS provided to the majority
of full-benefit dually eligible individuals eligible to enroll in the
FIDE SNP who use Medicaid LTSS. Examples of permissible LTSS carve-outs
for FIDE SNPs that apply to a minority of full-benefit dually eligible
LTSS users may include services specifically limited to individuals
with intellectual or developmental disabilities, individuals with
traumatic brain injury, or children. Carve-outs of specific Medicaid
LTSS would be permissible if the carved-out services would typically
only be a small component of the broad array of LTSS provided to the
majority of Medicaid LTSS users eligible to enroll in the FIDE SNP. We
would not, however, expect to approve carve-outs for LTSS services for
a specific population--for example, individuals with intellectual or
developmental disabilities--if enrollment in the FIDE SNP was limited
to individuals with those disabilities. For example, personal emergency
response systems or home modifications may be important supports for
participants in a Medicaid home and community-based waiver program.
However, those specific services would rarely constitute the
preponderance of an enrolled dually eligible individual's care plan
because most individuals receiving such services also receive other
types of in-home supports, such as personal care services. In contrast,
we would not expect to approve carve-outs of in-home personal care or
related services provided to older adults or people with disabilities
even if such services were limited to individuals meeting a nursing
home level of care.
D-SNPs can currently obtain the HIDE SNP designation with limited
carve-outs of Medicaid behavioral health services from their capitated
contracts. A behavioral health services carve-out would be of limited
scope if such service: (1) Applies primarily to a minority of the full-
benefit dually eligible users of behavioral health services eligible to
enroll in the HIDE SNP; or (2) constitutes a small part of the total
scope of behavioral health services provided to the majority of
beneficiaries eligible to enroll in the HIDE SNP. We specify that only
a small part of the Medicaid behavioral health services may be carved
out in order to ensure that the innovative services that many Medicaid
programs provide to individuals with severe and moderate
[[Page 1868]]
mental illness are covered through the D-SNP or the affiliated Medicaid
managed care plan. We believe that level of integrated coverage is a
minimum standard for a D-SNP to be considered highly or fully
integrated. It would be insufficient for a HIDE SNP or FIDE SNP to
solely cover the counseling services where Medicare is primary.
Examples of permissible carve-outs that apply to primarily a minority
of full-benefit dually eligible users of such services who are eligible
to enroll in the HIDE SNP include school-based services for individuals
under 21 years of age and court-mandated services. Examples of
permissible carve-outs that constitute a small part of the total scope
of Medicaid behavioral health services include inpatient psychiatric
facilities and other residential services, such as payment of Medicare
cost-sharing or coverage of days not covered by Medicare; substance
abuse treatment, such as payment of Medicare cost-sharing or coverage
of services not covered by Medicare; services provided by a Federal
Qualified Health Center or Rural Health Clinic; and Medicaid-covered
prescription drugs for treatment of behavioral health conditions. We
believe such carve-outs would still allow FIDE SNPs and HIDE SNPs to
meaningfully integrate Medicaid behavioral health coverage for their
enrollees. We seek comment on whether we have struck the right balance
in permitting such carve-outs, including for the examples cited
previously.
Specifically, we propose the following language at Sec. 422.107:
<bullet> Add new paragraph (g) to describe that a D-SNP may meet
the FIDE SNP or HIDE SNP definition at Sec. 422.2 even if the contract
between the State and the plan carves out some Medicaid LTSS, as long
as the carve-out, as approved by CMS, applies primarily to a minority
of beneficiaries eligible to enroll in the D-SNP who use long-term
services and supports or constitutes a small part of the total scope of
Medicaid LTSS provided to the majority of beneficiaries eligible to
enroll in the D-SNP;
<bullet> Add new paragraph (h) to describe that a D-SNP may meet
the FIDE SNP or HIDE SNP definition at Sec. 422.2 even if the contract
between the State and the plan carves out some Medicaid behavioral
health services, as long as the carve-out, as approved by CMS, applies
primarily to a minority of beneficiaries eligible to enroll in the D-
SNP who use behavioral health services or constitutes a small part of
the total scope of behavioral health services provided to the majority
of beneficiaries eligible to enroll in the D-SNP; and
<bullet> Redesignate paragraph (e) ``Date of Compliance'' as new
paragraph (i) due to the proposed new paragraphs (e) through (h).
We intend to administer this proposed regulation consistent with
our current policy and therefore anticipate little disruption to occur
because of this proposed change.
f. Service Area Overlap Between FIDE SNPs and HIDE SNPs and Companion
Medicaid Plans
MA organizations can achieve greater integration when they
maximally align their FIDE SNP and HIDE SNP service areas with the
service areas of the affiliated Medicaid managed care plan (meaning the
entities that offer capitated Medicaid benefits for the same members
under a capitated contract with the State). Service area alignment also
better comports with the minimum Medicare-Medicaid integration
standards established by section 50311(b) of the BBA of 2018, which
amended section 1859 of the Act and is codified at Sec. 422.2.
Currently, under Sec. 422.2, a D-SNP can meet the requirements to
be designated as a FIDE SNP and HIDE SNP even if the service area
within a particular State does not fully align with the service area of
the companion Medicaid plan (or plans) affiliated with their
organization.\80\ For FIDE SNP and HIDE SNP members outside the
companion Medicaid plan's service area, this lack of alignment does
little to integrate Medicare and Medicaid benefits as the D-SNP member
does not have the option to join the companion Medicaid plan. In its
June 2019 report to Congress, MedPAC illustrated service area
misalignment between D-SNPs and companion Medicaid managed LTSS plans,
finding a significant number of D-SNP members not in the same service
area as the D-SNP sponsor's Medicaid managed LTSS offering.\81\ In its
June 2021 report to Congress, MACPAC recommended States use the State
Medicaid agency contracts (required for D-SNPs by Sec. 422.107(b)) to
completely align service areas between a D-SNP and a Medicaid managed
care plan to better integrate coverage and care.\82\ We believe
requiring service area alignment in the definitions of FIDE SNP and
HIDE SNP would encourage MA organizations and States to create better
experiences for beneficiaries and move toward greater integration,
which would be consistent with the amendments to section 1859(f) of the
Act made by section 50311(b) of the BBA of 2018.
---------------------------------------------------------------------------
\80\ CMS has acknowledged this and encouraged MA organizations
to align these service areas in guidance issued on January 17, 2020,
regarding D-SNPs. See <a href="https://www.cms.gov/files/document/cy2021dsnpsmedicaremedicaidintegrationrequirements.pdf">https://www.cms.gov/files/document/cy2021dsnpsmedicaremedicaidintegrationrequirements.pdf</a>.
\81\ Medicare Payment Advisory Commission, ``Report to the
Congress: Medicare and the Health Care Delivery System,'' June 2019.
Retrieved from: <a href="https://medpac.gov/docs/default-source/reports/jun19_medpac_reporttocongress_sec.pdf">https://medpac.gov/docs/default-source/reports/jun19_medpac_reporttocongress_sec.pdf</a>.
\82\ MACPAC, Report to Congress on Medicaid and CHIP, ``Chapter
6: Improving Integration for Dually Eligible Beneficiaries:
Strategies for State Contracts with Dual Eigible Special Needs
Plan,'' June 2021. Retrieved at: <a href="https://www.macpac.gov/wp-content/uploads/2021/06/June-2021-Report-to-Congress-on-Medicaid-and-CHIP.pdf">https://www.macpac.gov/wp-content/uploads/2021/06/June-2021-Report-to-Congress-on-Medicaid-and-CHIP.pdf</a>.
---------------------------------------------------------------------------
Under our authority at section 1859(f)(8)(D) of the Act to require
that all D-SNPs meet certain minimum criteria for Medicare and Medicaid
integration, we are proposing to amend the definitions of FIDE SNP and
HIDE SNP at Sec. 422.2. We propose to amend the FIDE SNP definition by
adding new paragraph (6) and the HIDE SNP definition by adding new
paragraph (3) to require that the capitated contracts with the State
Medicaid agency cover the entire service area for the D-SNP for plan
year 2025 and subsequent years. Requiring the service area of the
Medicaid capitated contract to include at least the service area of the
D-SNP contract allows all FIDE SNP and HIDE SNP enrollees to access
both Medicare and Medicaid benefits from a single parent organization.
These proposed changes to Sec. 422.2 are in addition to the other
edits proposed to the definitions of FIDE SNP and HIDE SNP at Sec.
422.2 as described in this proposed rule.
Our proposal addresses an unintended loophole to the minimum D-SNP
integration criteria we have adopted as part of the definitions of FIDE
SNP and HIDE SNP: Where a D-SNP can qualify as either a FIDE SNP or
HIDE SNP by only having a small portion of its members in the same
service area as the companion Medicaid plan. Where the overlap in the
service areas for the separate MA D-SNP contract and the Medicaid
capitated contract is small, the opportunity for Medicare-Medicaid
integration is similarly limited as only enrollees in that overlapping
area have the potential to receive benefits from an integrated plan
with both MA and Medicaid managed care plan contracts under a single
parent organization. In such a FIDE SNP or HIDE SNP, the members
without access to the companion Medicaid plan might not benefit even
from the improved care coordination possible under the notification
requirement at Sec. 422.107(d) required for a D-SNP that is not a FIDE
SNP or HIDE SNP if the State has not imposed that requirement. We do
not believe that is consistent with the goals and purposes
[[Page 1869]]
of increasing integration for D-SNPs as a whole or particularly for
FIDE SNPs and HIDE SNPs, which are supposed to have more than a bare
minimum level of integration.
The proposal is not intended to limit State options for how they
contract with managed care plans for their Medicaid programs, but to
require the FIDE and HIDE SNPs to limit their MA service areas to areas
within the service areas for the companion Medicaid plan. Our proposal
would not limit the service area of the companion Medicaid plan to that
of the D-SNP service area. Therefore, the companion Medicaid plan may
have a larger service area than the D-SNP. States, in their contracting
arrangements for Medicaid managed care programs, may wish to limit the
service areas of the affiliated Medicaid managed care plans, but we
recognize that States have other policy objectives better met with
larger service areas in their Medicaid managed care programs.
In plan year 2021, all FIDE SNPs meet the service area requirement
being proposed. Most, but not all, HIDE SNPs also meet the proposed
requirement. As of June 2021, there were 1,302,505 HIDE SNP members
across 16 States in 186 HIDE SNP plan benefit packages and 89
contracts.\83\ In four States, 20 HIDE SNPs have service area gaps with
their affiliated MCOs, leaving 97,004 members in 174 counties with no
corresponding Medicaid plan.\84\ Approximately half the D-SNPs with
unaligned service area have over 50 percent of their enrollment in the
unaligned service area, and the vast majority of HIDE SNP members and
counties with unaligned service areas are concentrated in one State and
one parent organization. Therefore, we believe some HIDE SNPs have only
met the D-SNP integration requirements for a fraction of their
enrollment due to the unintended gap in integration that is created by
a lack of service area alignment.
---------------------------------------------------------------------------
\83\ CMS, SNP Comprehensive report, June 2021. Retrieved at:
<a href="https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldataspecial-needs/snp-comprehensive-report-2021-06">https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldataspecial-needs/snp-comprehensive-report-2021-06</a>.
\84\ Internal analysis based on data from: CMS, Monthly
Enrollment by Contract, March 2021. Retrieved from: <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Enrollment-by-Contract">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Enrollment-by-Contract</a>;
CMS, Monthly Enrollment by Contract/Plan/State/County, March 2021.
Retrieved from: <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Enrollment-by-Contract">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Monthly-Enrollment-by-Contract</a>-Plan-State-County; CMS, D-SNP Integration
Levels for CY 2021. Retrieved from: <a href="https://www.cms.gov/files/document/smacdsnpintegrationstatusesdata.xlsx">https://www.cms.gov/files/document/smacdsnpintegrationstatusesdata.xlsx</a>; and service area
information from State Medicaid agency websites.
---------------------------------------------------------------------------
If finalized, an MA organization impacted by our proposal would
have several options. First, the organization can work with the State
to expand their companion Medicaid plan service area to the full D-SNP
service area, thus increasing the opportunity for integrated care and
qualifying as a HIDE SNP under our proposal. Second, the MA
organization can request to crosswalk enrollees (using the crosswalk
exception currently at Sec. 422.530(c)(4), which we are proposing to
redesignate as Sec. 422.530(c)(4)(i) in section II.A.6.a.) from the
existing D-SNP that includes the service area outside of the companion
Medicaid plan service area into a new D-SNP; the end result is two
separate D-SNPs, one which qualifies as a HIDE SNP (because it has the
overlapping service area with the companion Medicaid plan and meets
other requirements) and another D-SNP that, because it is neither a
FIDE SNP nor a HIDE SNP, would need to meet the notification
requirement at Sec. 422.107(d). Third, the MA organization can keep
the existing service area for the existing D-SNP and contract with the
State as a non-HIDE D-SNP by meeting the notification requirement at
Sec. 422.107(d).
These options all require the MA organization to collaborate with
the State Medicaid agency. We believe that a State currently engaged
with MA organizations to integrate care through a HIDE SNP would likely
be willing to work with the MA organization to come into compliance
with the proposed rule. However, if the State was unwilling to engage
with the MA organization, the MA organization would need to end the
HIDE SNP plan benefit package in the unaligned service area. We seek
comment on whether this proposal would likely result in additional,
unintended disruption for current HIDE SNP membership, particularly if
such unintended disruption is for more than the initial year of
transition. We generally believe that the additional integration--and
the benefits from higher integration--outweigh the limited disruption
potentially caused by realignment of FIDE SNP and HIDE SNP service
areas to meet this proposed requirement by 2025.
We are considering an alternative of establishing a minimum
percentage of enrollment or service area overlap between the D-SNP
affiliated Medicaid plan and having FIDE SNPs and HIDE SNPs attest to
meeting the minimum overlap requirement. That is, a D-SNP would qualify
as a FIDE SNP or HIDE SNP if a minimum percentage of the D-SNP
enrollment resides in the companion Medicaid plan (or plans) service
area or if a minimum percentage of the D-SNP service area overlaps with
the companion Medicaid plan (or plans). We are also considering an
amendment to explicitly codify how the current requirements permit D-
SNPs to be designated as a FIDE SNP or HIDE SNP even if their service
area within a particular State does not fully align with the service
area of the companion Medicaid plan (or plans). We are not proposing
either of these alternative approaches because we believe these
alternatives create greater operational complexity (in the case of
establishing a minimum percentage overlap) and would fail to help us
achieve our objectives of clarifying options for beneficiaries and
creating better coordination of Medicare and Medicaid benefits for all
enrollees of the FIDE SNP or HIDE SNP compared to current practice. We
seek comment on these alternatives, including input on what an
appropriate percentage threshold of overlap in the services areas
should be, whether an attestation process would provide the necessary
level of oversight, and whether the status quo, with a clarification in
the regulation text, creates a sufficient level of integration for FIDE
SNPs and HIDE SNPs. We are interested in comments on whether the
alternatives create sufficient improvements in coordination of the
Medicare and Medicaid benefits compared to current practice or if the
alternatives would adequately address the policy goals outlined in this
proposal.
6. Additional Opportunities for Integration Through State Medicaid
Agency Contracts (Sec. 422.107)
Section 164 of MIPPA amended section 1859(f) of the Act to require
that each D-SNP contract with the State Medicaid agency to provide
benefits, or arrange for the provision of Med
[…truncated; see source link]Indexed from Federal Register on January 12, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.