Rule2022-09375
Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 9, 2022
Effective
June 28, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This final rule will 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 final rule will also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans. This final rule finalizes certain 2021 and 2022 Star Ratings provisions that were included in two interim final rules with comment period (IFC) that CMS issued on April 6, 2020, and September 2, 2020; other policies from those interim final rules will be addressed in other rulemakings.
Full Text
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[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Rules and Regulations]
[Pages 27704-27902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09375]
[[Page 27703]]
Vol. 87
Monday,
No. 89
May 9, 2022
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 417, 422, and 423
Medicare Program; Contract Year 2023 Policy and Technical Changes to
the Medicare Advantage and Medicare Prescription Drug Benefit Programs;
Policy and Regulatory Revisions in Response to the COVID-19 Public
Health Emergency; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency; Final Rule
Federal Register / Vol. 87 , No. 89 / Monday, May 9, 2022 / Rules and
Regulations
[[Page 27704]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 417, 422, and 423
[CMS-4192-F, CMS-1744-F, and CMS-3401-F]
RIN 0938-AU30, 0938-AU31, and 0938-AU33
Medicare Program; Contract Year 2023 Policy and Technical Changes
to the Medicare Advantage and Medicare Prescription Drug Benefit
Programs; Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency; Additional Policy and Regulatory Revisions in
Response to the COVID-19 Public Health Emergency
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This final rule will 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 final rule
will also revise regulations related to dual eligible special needs
plans (D-SNPs), other special needs plans, and cost contract plans.
This final rule finalizes certain 2021 and 2022 Star Ratings provisions
that were included in two interim final rules with comment period (IFC)
that CMS issued on April 6, 2020, and September 2, 2020; other policies
from those interim final rules will be addressed in other rulemakings.
DATES:
Effective dates: These regulations are effective on June 28, 2022,
except for amendatory instructions 27 and 36 (regarding the definition
of ``negotiated price'' at Sec. Sec. 423.100 and 423.2305), which are
effective January 1, 2024.
Applicability dates: The applicability date of the provisions in
this rule is January 1, 2023, except as explained in SUPPLEMENTARY
INFORMATION.
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#7f2f1e0d0b3c1e111b3b2c0b1e0d2d1e0b1611180c3f1c120c5117170c51181009"><span class="__cf_email__" data-cfemail="86d6e7f4f2c5e7e8e2c2d5f2e7f4d4e7f2efe8e1f5c6e5ebf5a8eeeef5a8e1e9f0">[email protected]</span></a>--Part C and D Star Ratings Issues.
Marna Metcalf-Akbar, (410) 786-8251--D-SNP Issues.
<a href="/cdn-cgi/l/email-protection#4010213234041021392d252e34102f2c29233900232d336e2828336e272f36"><span class="__cf_email__" data-cfemail="87d7e6f5f3c3d7e6feeae2e9f3d7e8ebeee4fec7e4eaf4a9efeff4a9e0e8f1">[email protected]</span></a>--Part D Pharmacy Price Concession
Issues.
<a href="/cdn-cgi/l/email-protection#feb3b2ac8c9b8e918c8abe9d938dd096968dd0999188"><span class="__cf_email__" data-cfemail="763b3a2404130619040236151b05581e1e0558111900">[email protected]</span></a>--MLR Issues.
SUPPLEMENTARY INFORMATION:
Acronyms
ACC Automated Criteria Check
AHC Accountable Health Communities
AKS Anti-kickback Statute
ANOC Annual Notice of Change
ARB At-Risk Beneficiaries
BBA Bipartisan Budget Act
CAHPS Consumer Assessment of Healthcare Providers and Systems
CAI Categorical Adjustment Index
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
EGWP Employer Group Waiver Plan
EOC Evidence of Coverage
FAI Financial Alignment Initiative
FDR First-Tier Downstream and Related Entity
FFS Fee-for-Service
FIDE SNP Fully Integrated Dual Eligible Special Needs Plan
FQHC Federally Qualified Health Center
HEDIS Healthcare Effectiveness Data and Information Set
HHS Department of Health and Human Services
HIDE SNP Highly Integrated Dual Eligible Special Needs Plan
HIPAA Health Insurance Portability and Accountability Act of 1996
HOS Health Outcomes Survey
HPMS Health Plan Management System
HRA Health Risk Assessment
HSD Health Service Delivery
ICR Information Collection Requirement
IRE Independent Review Entity
I-SNP Institutional Special Needs Plan
LOI Letter of Intent
LTSS Long Term Services and Supports
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
MMCO Medicare-Medicaid Coordination Office
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
PAHP Prepaid Ambulatory Health Plan
PBP Plan Benefit Package
PDE Prescription Drug Event
PDP Prescription Drug Plan
PHE Public Health Emergency
PIHP Prepaid Inpatient Health Plan
PRA Paperwork Reduction Act
RFI Request for Information
RFA Regulatory Flexibilities Act
RHC Rural Health Clinic
SAE Service Area Expansion
SB Summary of Benefits
SDOH Social Determinants of Health
SHIP State Health Insurance Assistance Program
SNP Special Needs Plan
SSA Social Security Administration
SSBCI Special Supplemental Benefits for the Chronically Ill
TPMO Third-Party Marketing Organization
Additional information regarding the applicability dates: The Star
Ratings provision at Sec. 422.166(i)(12) is applicable to the
calculation of the 2023 Star Ratings released in October, 2022, as
discussed in section II.D.2. of this final rule. The definition of
``fully integrated dual eligible special needs plans (FIDE SNP)'' in
Sec. 422.2 at paragraphs (2)(i) and (iii) through (v), (5), and (6) as
discussed in section II.A.5 of this final rule are applicable beginning
January 1, 2025. The definition of ``highly integrated dual eligible
special needs plans'' in Sec. 422.2 at paragraph (3), as discussed in
section II.A.5.f. of this final rule, is applicable beginning January
1, 2025. The applicability date of the requirements at Sec. 422.101,
as discussed in section II.A.4. of this final rule, is January 1, 2024.
The requirements at Sec. 423.100, as discussed in section II.H. of
this final rule, are applicable beginning on January 1, 2024.
I. Executive Summary
A. Purpose
Over 29 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 23 million
individuals receive Part D coverage through standalone Part D plans.
The primary purpose of this final rule is to
[[Page 27705]]
implement changes to the MA and Part D programs. This final rule
implements 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 final rule also revises
regulations related to dual eligible special needs plans (D-SNPs),
other special needs plans, and Medicare cost contract plans.
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\ Through this final rule, we require that any MA
organization offering a D-SNP establish one or more enrollee advisory
committees in each State to solicit direct input on enrollee
experiences. We also establish that the committee must 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. Public comments on our proposal reinforced our
belief 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.
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\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>.
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2. Standardizing Housing, Food Insecurity, and Transportation Questions
on Health Risk Assessments (Sec. 422.101)
Section 1859(f)(5)(A)(ii)(I) of the 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. Building on CMS's experience with other programs and model
tests, and with broad support from public commenters, we are finalizing
a requirement that all SNPs include one or more questions from a list
of screening instruments specified in sub-regulatory guidance on
housing stability, food security, and access to transportation as part
of their health risk assessments (HRAs). However, based on public
comments, we are not finalizing our proposal that all SNPs use the same
specific standardized questions.
Our final rule will 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 will better equip the MA organizations offering these SNPs to
meet the needs of their members. Our final rule will also equip these
MA organizations with person-level information that will help them
better connect people to covered services, social service
organizations, and public programs that can help resolve housing
instability, food insecurity, or transportation challenges.
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 proposed 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 increase integration for these types of D-SNPs.
In this final rule, we are requiring, for 2025 and subsequent
years, that all FIDE SNPs have exclusively aligned enrollment, as
defined in Sec. 422.2, and cover Medicare cost-sharing and three
specific categories of Medicaid benefits: Home health services (as
defined in Sec. 440.70), medical supplies, equipment, and appliances
(as described in Sec. 440.70(b)(3)), and behavioral health services
through a capitated contract between the State Medicaid agency and the
Medicaid managed care organization that is the same legal entity as the
MA organization that offers the FIDE SNP. In addition, we are requiring
that, for plan year 2025 and subsequent years, each HIDE SNP have a
service area that completely overlaps the service area of the
affiliated Medicaid managed care plan with the capitated contract with
the State. Consistent with existing policy outlined in sub-regulatory
guidance, this final rule also codifies specific, limited carve-outs of
the Medicaid long-term services and supports and Medicaid behavioral
health services covered under the Medicaid capitated contract
affiliated with FIDE SNPs and HIDE SNPs.
We believe these policies 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. In this final rule we 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) use certain
integrated materials and notices for enrollees. Where States choose
this opportunity, it will help individuals better understand their
coverage. Because Star Ratings are assigned at the contract level, this
final rule will also provide a mechanism to provide States 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 codify 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 will improve Federal and State oversight of certain D-SNPs
(and their affiliated Medicaid managed care plans) through greater
information-sharing among government regulators.
[[Page 27706]]
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 increased State payments of
Medicare cost-sharing and disadvantages providers serving dually
eligible individuals in MA plans. In this final rule we 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) must be 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 (including cost-sharing that
remains unpaid because of State limits on the amounts paid for Medicare
cost-sharing and dually eligible individuals' exemption from Medicare
cost-sharing). The change will result in more equitable payment for MA
providers serving dually eligible beneficiaries. We project that our
requirement as finalized will result in increased bid costs for the
MOOP for some MA plans. A portion of those higher bid costs will 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 Federal 10-
year cost estimate for the finalized requirement is $614.8 million.
6. Special Requirements During a Disaster or Emergency for Medicare
Advantage Plans (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 specific depending on the type or scope
of the disaster or emergency, while other situations, like the 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. In this final rule, we clarify the period
of time during which MA organizations must comply with the special
requirements. Under this final rule, MA organizations must ensure
access for enrollees to covered services throughout the disaster or
emergency period, including when the end date is unclear and the period
renews several times, so long as there is a disruption of access to
healthcare.
7. Amend MA Network Adequacy Rules by Requiring a Compliant Network at
Application (Sec. 422.116)
We proposed 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 will 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 1 year ahead of
the beginning of the contract as the proposed change for network
adequacy rules will require. Therefore, the final rule 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 will no longer apply and MA
organizations will need to meet full compliance.
We are finalizing our proposal, with one modification; to allow
applicants to utilize Letters of Intent (LOIs) to meet network
standards in counties and specialty types as needed. Once the contract
is operational, MA organizations must have signed contracts with
providers and facilities to be in full compliance.
8. Part C and Part D Quality Rating System
Due to the scope and duration of the COVID-19 PHE, we adopted a
technical change to the 2022 Star Ratings methodology for extreme and
uncontrollable circumstances in the ``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''
published in the Federal Register and effective on September 2, 2020
(hereafter referred to as the ``September 2nd COVID-19 IFC''),\2\ (CMS-
3401-IFC; 85 FR 54820) at 42 CFR 422.166(i)(11) to make it possible for
us to calculate 2022 Star Ratings for MA contracts. We proposed 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
(87 FR 1842, January 12, 2022). 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. We are therefore finalizing Sec. 422.166(i)(12)
without modification. In this final rule, we also respond to comments
we received on the Medicare Advantage and Part D Star Ratings
provisions in the interim final rules titled ``Medicare and Medicaid
Programs; Policy and Regulatory Revisions in Response to the COVID-19
Public Health Emergency'' published in the Federal Register on April 6,
2020,
[[Page 27707]]
with a March 31, 2020 effective date (hereafter referred to as the
``March 31st COVID-19 IFC'') \3\ (85 FR 19230) and the September 2nd
COVID-19 IFC. As detailed in sections II.D.3. and II.D.4. of this final
rule, we are finalizing most of the Star Ratings provisions from the
March 31st COVID-19 IFC and the September 2nd COVID-19 IFC, but we are
not finalizing several Star Ratings provisions in those interim final
rules, regarding circumstances that did not happen, because they are
moot. CMS will address other provisions from the interim final rules in
other rulemakings.
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\2\ <a href="http://www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient">www.federalregister.gov/documents/2020/09/02/2020-19150/medicare-and-medicaid-programs-clinical-laboratory-improvement-amendments-clia-and-patient</a>.
\3\ <a href="http://www.federalregister.gov/documents/2020/04/06/2020-06990/medicare-and-medicaid-programs-policy-and-regulatory-revisions-in-response-to-the-covid-19-public">www.federalregister.gov/documents/2020/04/06/2020-06990/medicare-and-medicaid-programs-policy-and-regulatory-revisions-in-response-to-the-covid-19-public</a>.
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9. Past Performance Methodology to Better Hold Plans Accountable for
Violating CMS Rules (Sec. Sec. 422.502 and 422.503)
In a 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 a new contract 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. In this final rule, we 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
third-party marketing organizations (TPMOs) and has received feedback
from beneficiary advocates and stakeholders concerned about the
marketing practices of 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 is 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 this final rule, we will address the
concerns with TPMOs by means of the following three updates to the
communications and marketing requirements under 42 CFR parts 422 and
423, subpart V: (1) We 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 add a new disclaimer that
will be required when TPMOs market MA plans/Part D products (Sec. Sec.
422.2267(e) and 423.2267(e)); and (3) we update 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 (FDR).
CMS' January 2021 final rule, entitled ``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) 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 Affordable Care Act. In the months since the publication of this
rule, CMS gained additional insight regarding the void created by the
lack of these 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, in this final rule we are finalizing a
requirement that MA and Part D plans create a multi-language insert
that will inform the reader, in the top fifteen languages used in the
U.S., as well as any additional non-English language that is the
primary language of at least 5 percent of the individuals in a plan
benefit package service area, 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. As part of the finalized requirement, plans will be required
to include 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). We further note
that existing statutes, including Section 504 of the Rehabilitation Act
and 1557 of the Affordable Care Act, require the provision of any
auxiliary aids and services required for effective communication for
individuals with disabilities at no cost to the individual.
Finally, in this final rule we are 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 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, the new MLR reporting
templates will require 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. Sec. 423.100 and 423.2305)
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
proposed to eliminate this exception for contingent pharmacy price
concessions (87 FR 1842, January 12, 2022). We proposed 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 proposed to define as the lowest amount a pharmacy
could
[[Page 27708]]
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 will 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). We proposed to allow plans the flexibility to
determine how much of the pharmacy price concessions to pass through at
the point of sale for applicable drugs in the coverage gap phase of the
benefit. After consideration of the comments, we are modifying our
proposal to apply the new definition of ``negotiated price'' to all
phases of the Part D benefit, including the coverage gap phase. We are
also amending the definition of ``negotiated price'' at Sec. 423.2305
by revising paragraphs (1) and (2) of the definition of ``negotiated
price'' for the Coverage Gap Discount Program to be consistent with the
definition of ``negotiated price'' that we are adopting at Sec.
423.100 (that is, the lowest possible reimbursement such network entity
will receive, in total, for a particular drug). This policy takes
effect 60 days after publication of the final rule and is applicable
beginning on January 1, 2024. Part D sponsors will need to account for
these changes in the bids that they submit for contract year 2024.
In this final rule, we 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 had not yet been defined in the
Part D statute, Part D regulations, or sub-regulatory guidance. We
define price concession to include any form of discount, direct or
indirect subsidy, or rebate received by the Part D sponsor or its
intermediary contracting organization from any source that serves to
decrease the costs incurred under the Part D plan by the Part D
sponsor.
C. Summary of Costs and Benefits
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D. Background
We received approximately 6,179 timely pieces of correspondence
containing one or more comments for the provisions addressed in this
final rule from the proposed rule titled ``Medicare Program; Contract
Year 2023 Policy and Technical Changes to the Medicare Advantage and
Medicare Prescription Drug Benefit Programs'' which appeared in the
Federal Register on January 12, 2022 (hereafter referred to as the
January 2022 proposed rule, 87 FR 1842). Comments were submitted by MA
health plans, Part D sponsors, beneficiaries, MA enrollee and
beneficiary advocacy groups, trade associations, providers, pharmacies
and drug companies, States, telehealth and health technology
organizations, policy research organizations, actuarial and law firms,
MACPAC, MedPAC, Members of Congress, and other vendor and professional
associations.
The proposals we are finalizing in this final rule range from minor
clarifications to more significant modifications based on the comments
received. Summaries of the public comments received and our responses
to those public comments are set forth in the various sections of this
final rule under the appropriate headings.
We received an overarching comment related to the proposed rule,
which we summarize in the following paragraphs:
Comment: A commenter expressed a concern about the timing of the
provisions included in the proposed rule related to the deadline for
bid submissions, especially related to proposals with contract year
2023 effective dates. The commenter noted that several proposals would
require operational and technical changes for MA organizations as well
as additional resource allocations, and, as such, welcomed additional
time for implementation. The commenter suggested it could better align
and collaborate with CMS in the future if given more time to fully
understand and implement proposed changes.
Response: We understand and appreciate the commenter's concerns and
MA organizations and Part D sponsors' willingness to work to meet the
implementation date timeframes. In response to comments, we are
modifying the date on which some of the new and amended regulations in
this final rule become applicable. We describe these modifications in
further detail in the respective sections of the rule.
We also note that some of the public comments received for the
provisions implemented in this final rule were outside of the scope of
the proposed rule. As such, these out-of-scope public comments are not
addressed in this final rule. The following paragraphs summarize the
out-of-scope public comments.
A commenter noted that long-term care provider-led institutional
special needs plans (I-SNPs) offer a strong additional solution to
States in integrated efforts, especially for long-term care services
uses with complex, high risk needs.
We received a few comments related to D-SNP look-alikes, which are
addressed at Sec. 422.514(d). A commenter requested that CMS consider
reducing the threshold for a D-SNP look-alike from the current 80
percent of dually eligible individuals enrolled to 50 percent and
requiring the Medicare program to inform individuals that they are
enrolling in a non-integrated model where an integrated model exists.
Without such action, this commenter expressed that D-SNP look-alikes
could undermine progress on integration,
[[Page 27713]]
leading to the erosion of D-SNP enrollment over time and additional
beneficiary confusion. Another commenter requested that CMS reconsider
its current policy for States without a D-SNP option for partial-
benefit dually eligible individuals by either allowing these
individuals to enroll in FIDE SNPs or excluding them from the 80-
percent threshold calculation used to determine D-SNP look-alikes in
these States.
A few commenters encouraged CMS to consider applying other MMP
design elements to D-SNPs. These included extending contract management
teams to HIDE SNPs and FIDE-SNPs, D-SNPs with exclusively aligned
enrollment, and/or D-SNPs with a meaningful proportion of enrollees who
receive Medicaid benefits from a managed care plan affiliated with the
D-SNP; requiring D-SNPs to develop single case agreement policies to
enable enrollees to see out-of-network providers; applying MMP program
audit rules and protocols to D-SNPs with exclusively aligned
enrollment; and allowing beneficiaries to enroll in integrated plans on
a monthly basis rather than the roughly quarterly enrollment
opportunities under MA.
MACPAC noted that while the provisions in the proposed rule promote
integration in existing products, they do not necessarily increase the
availability of integrated models or enrollment in integrated plans and
urged CMS to look for ways to expand policies to promote integration
beyond D-SNPs with exclusively aligned enrollment in future rulemaking.
A commenter encouraged CMS to reconsider its approach to setting
separate requirements for D-SNPs and Medicaid managed care plans and to
align Federal regulations for FIDE SNPs with those that already exist
for Medicaid managed care.
A commenter recommended that CMS take steps to reduce limitations
on data sharing between plans and States and provide additional
guidance on creating a standardized and electronic method to integrate
information in model materials.
A few commenters recommended that CMS take steps to ensure that
quality measurement is appropriately targeted to the populations served
by each product and that measurement and related financial incentives
do not disproportionately penalize D-SNPs for serving populations with
greater risk factors. Other commenters urged CMS to require all States
to adopt standardized, disability-informed quality measurement tools so
that measures are collected and reported in a uniform format.
A few commenters expressed concern related to quality measurement
for D-SNPs more broadly. A commenter stated that because of the
challenges inherent to serving younger dually eligible beneficiaries
with disabilities who represent the most complex and at-risk Medicare
members with the most social risk factors, plans serving this
population have less quality bonus funding available to support
supplemental benefits tailored to the population.
A commenter suggested CMS consider revising the requirement that
the D-SNP and Medicaid managed care plan contract holder must be the
same legal entity in order to qualify as a FIDE SNP; instead, the
commenter recommended using the same requirement that is used for HIDE
SNPs that the contract holder is the same parent organization or
another entity that is owned and controlled by its parent organization.
A few commenters requested CMS consider additional financial
policies. A commenter encouraged CMS to require States to ensure that
the capitated payments for HIDE SNPs and FIDE SNPs are documented in
the State Medicaid agency contract. Another commenter noted that the
existing risk adjustment methodology is not sensitive to pick up all of
the nuances for D-SNPs that largely serve populations with more complex
care. A commenter requested that CMS consider clarifying elements of
the cost-sharing billing process during an enrollee's Medicare deeming
period, including prohibiting Medicare cost-sharing being billed to
dually eligible individuals during the Medicare deeming period.
A commenter requested guidance on how to handle cost-sharing for
supplemental benefits that may overlap with what is provided by
Medicaid.
A commenter expressed concern regarding the complaint resolution
process for dually eligible individuals, noting that it is fragmented
and confusing when some issues are handled by State Medicaid agencies
or plans while others are handled by CMS or MA plans. The commenter
noted that ``no wrong door'' policies for enrollee concerns are
critical to ensuring complaints are addressed.
A commenter urged CMS to consider the limited availability of
transportation options in rural communities when finalizing the
proposed rule.
A commenter expressed interest in additional research to better
understand fluctuations within dual eligibility and what may cause a
partial-benefit dually eligible individual to become a full-benefit
dually eligible individual and encouraged CMS to assess whether
integrated models can help prevent partial-benefit dual eligible
individuals from necessitating full-benefit status.
A commenter suggested that another approach to improving integrated
care is to establish a single program that would provide dually
eligible beneficiaries with their medical, long-term care, behavioral,
and social needs. They further suggested the program allow States to
contract with the administering entities, which would bear two-sided
risk to ensure accountability and eliminate incentives for cost-
shifting.
A commenter expressed concerns about the MA program overall,
including inadequate care provided to MA enrollees, low payments to
providers, and high MA payment rates compared to the original Medicare
fee-for-service (FFS) program.
CMS received a number of comments regarding extending the COVID-19
disaster adjustments that all contracts received for the 2022 Star
Ratings for measures other than HEDIS-HOS measures and reducing the
weight applied to the patient experience/complaints and access measures
for the 2023 Star Ratings.
CMS received many comments regarding network adequacy requirements
and policies that are outside of the scope of this rule. Some
commenters indicated that CMS should consider reinstating previous
network adequacy standards including returning to the 90 percent rate
of beneficiary requirements within time and distance standards for
micro, rural and counties with extreme access considerations, as well
as including dialysis facilities as a specialty type evaluated for
network adequacy under Sec. 422.116(b). Many commenters recommended
that CMS add criteria to our current network adequacy standards. For
example, commenters recommended that CMS add new provider and facility
specialty types, including sub-specialty types, to our list of those
which are evaluated for network adequacy standards under Sec.
422.116(b). Some commenters suggested that CMS increase the frequency
in which network adequacy formal reviews are conducted or align the
triennial network adequacy review timelines with the application
timeline. A commenter suggested that CMS integrate network adequacy
into Star Ratings measures. A few commenters suggested that CMS
consider how increased use of telehealth-provided services will impact
network adequacy, and that CMS should consider expanding the telehealth
credit in certain county types such as rural
[[Page 27714]]
counties. A few commenters recommended CMS establish policies to
enhance information available in MA plan network directories. A
commenter suggested that CMS consider changes and improvements to the
network adequacy exceptions and criteria process. A commenter provided
recommendations regarding how network adequacy standards should
recognize and address the unique needs of enrollees in I-SNPs. A
commenter recommended CMS develop network standards specific to the D-
SNP population. Additional topics out of scope of this rule include
requests to update timelines for release of the Reference and Sample
Beneficiary Files, make MA organizations' network adequacy review data
publicly available, and limit organization's ability to make changes to
network providers throughout the contract year.
CMS received some comments regarding special requirements during
emergency and disasters that are out of scope for this rule. A
commenter asked CMS to provide guidance about online or point-of-sale
processing of Part B out-of-network claims during a disaster or
emergency. Another commenter expressed concerns that these requirements
do not apply to Part D drugs.
A commenter suggested that we take a more holistic approach to past
performance. The commenter suggested we review all contracts for past
performance and not just applicants.
We received several out-of-scope comments related to the provision
on applying all pharmacy price concessions to the negotiated price at
the point of sale. A few commenters urged CMS to address pharmacy
benefit managers' (PBMs') formularies, specifically the preference for
brand medications over generics due to the rebates and with respect to
the use of biosimilars as they launch. Many commenters asked that CMS
address the ``reasonable and relevant'' contracting terms and
conditions between MA organizations/plan sponsors and pharmacies. A few
commenters expressed concern with vertical integration of PBMs and
pharmacies. A few commenters were concerned about the costs of COVID-19
tests and treatments. Some commenters stated that CMS should not make
the changes associated with this Pharmacy Price Concessions rule when
it should instead be working to wind down or officially incorporate
policies put in place during the COVID-19 PHE. Some commenters stated
that the proposal failed to address the root cause of high drug prices
and offered recommendations for regulating the pharmaceutical industry.
A few commenters stated that PBMs should not set drug prices and
encouraged CMS to make sweeping reforms including a patient bill of
rights and a pharmacy bill of rights. A few commenters stated that PBMs
cannot engage in sub-capitation arrangements that require pharmacies to
bear risk. Some commenters requested CMS re-evaluate its policy on U.S.
Food and Drug Administration (FDA)-approved anti-obesity medications.
Other commenters recommended that CMS do more to improve access to the
Part D Low-Income Subsidy (LIS) program, noting the program's
importance to improving health equity and the nearly three million
beneficiaries who are eligible for the program but not enrolled. This
commenter also requested that CMS track and report on the number of
complaints received regarding Part D plans charging individuals
enrolled in the full LIS program the higher plan copayment rather than
the established LIS copayment.
Unless otherwise noted, cites to regulations are to title 42 of the
CFR.
II. Provisions of the Proposed Rule and Analysis of and Responses to
Public Comments
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.\4\
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\4\ 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\5\ coordination of Medicare and
Medicaid services, across primary, acute, long-term, behavioral, and
social domains;
---------------------------------------------------------------------------
\5\ ``Person-centered care'' typically refers to focusing care
on the needs of the individual and ensuring that a person's
individual preferences, needs, and values guide care decisions. This
is in contrast to approaches to care in which the specific diagnosis
or illness drives care and treatment decisions. See the National
Center on Advancing Person-Centered Practices and Systems for
additional information: <a href="https://ncapps.acl.gov/home.html">https://ncapps.acl.gov/home.html</a>.
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<bullet> Mitigate cost-shifting incentives, including total-cost-
of-care accountability across Medicare and Medicaid; and
<bullet> Create seamless experiences for beneficiaries.
We described at 87 FR 1849 through 1850 of the proposed rule 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. 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.\6\
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\6\ 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>.
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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 managed care
organization (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.
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.
[[Page 27715]]
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.
At 87 FR 1850 of the proposed rule, we described recent MA/Part D
rulemaking to enhance D-SNPs. 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. We
are working to improve and increase options for more integrated care in
a variety of ways, including through D-SNPs.
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 \7\ 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 2022,
approximately 4.0 million dually eligible individuals (more than 1 of
every 4 dually eligible individuals) were enrolled in 729 D-SNPs.\8\
---------------------------------------------------------------------------
\7\ ``Care coordination'' typically refers to the managing of
care and sharing of information among medical and non-medical
providers and supports across the spectrum primary, acute,
behavioral health, long-term services and supports. See, for
example, <a href="https://www.ahrq.gov/ncepcr/care/coordination.html">https://www.ahrq.gov/ncepcr/care/coordination.html</a>, and
Barth, S., Silow-Carroll, S., Reagan, Russell, M., Simmons, T.
(2019) Care Coordination in Integrated Care Programs Serving Dually
Eligible Beneficiaries--Health Plan Standards, Challenges and
Evolving Approaches. Report to the Medicaid and CHIP Payment and
Access Commission. <a href="https://www.macpac.gov/wp-content/uploads/2019/03/Care-Coordination-in-Integrated-Care-Programs-Serving-Dually-Eligible-Beneficiaries.pdf">https://www.macpac.gov/wp-content/uploads/2019/03/Care-Coordination-in-Integrated-Care-Programs-Serving-Dually-Eligible-Beneficiaries.pdf</a>.
\8\ 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">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data</a>.html.
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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 42 CFR
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 42 CFR 422.101(f), and
contracts with State Medicaid agencies as described in section
1859(f)(3)(D) of the Act and at 42 CFR 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).\9\
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\9\ 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>.
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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.\10\
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\10\ 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>.
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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. This State-Federal partnership is tested using
authority under 1115A of the Act (as added by section 3021 of the
Affordable Care Act) and further described below. 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. Our proposed rule at 87 FR 1851 through 1854
summarized the key elements offered by MMPs under the capitated model
demonstrations.
As discussed in the proposed rule at 87 FR 1851, CMS and States
partnered with MMPs to create a seamless experience for beneficiaries,
but MMPs operate as both MA organizations offering Medicare Advantage
Prescription Drug (MA-PD) plans 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 January 2022, there are 39 MMPs in nine States serving
approximately 424,000 members.\11\
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\11\ MMP enrollment as of January 2022. See CMS Monthly
Enrollment by Contract Report (January, 2022). Retrieved from
<a href="https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldatamonthly/enrollment-contract-2022-01">https://www.cms.gov/research-statistics-data-and-systemsstatistics-trends-and-reportsmcradvpartdenroldatamonthly/enrollment-contract-2022-01</a>.
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As summarized at 87 FR 1851 through 1854 in our proposed rule,
while an independent evaluation of the FAI is still underway, we have
already gleaned several lessons regarding integrated,
[[Page 27716]]
managed care from the capitated financial alignment model:
<bullet> Enrollee participation in governance helps identify and
address barriers to high-quality, coordinated care;
<bullet> Assessment processes are a vehicle for identifying and
addressing unmet needs, particularly those related to social
determinants of health;
<bullet> Medicare-Medicaid integration correlates with high levels
of beneficiary satisfaction;
<bullet> Carving in Medicaid behavioral health benefits helps
promote better coordination of behavioral health and physical health
services;
<bullet> Integrated beneficiary communication materials can enhance
the beneficiary experience;
<bullet> Effective joint oversight of integrated managed care
products is possible;
<bullet> Integrated care and joint oversight provide a platform for
quality improvement;
<bullet> There is potential for market distortions in areas with
multiple options targeting the same population; and
<bullet> State investment is critical to successful implementation
of integrated care either through MMPs or D-SNPs.
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. We proposed 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 in the proposed rule would incorporate
certain MMP policies into the regulations governing D-SNPs or, in
several cases, certain types of D-SNPs. We included a table (87 FR
1854) summarizing how our proposals relate to MMP policies. Section
II.A.14 of this final rule includes an updated version of that table to
reflect the policies adopted in this final rule.
Comment: Several commenters, including MACPAC, described the
challenges dually eligible individuals and their providers and families
experience navigating separate and fragmented Medicare and Medicaid
delivery systems. A commenter noted suboptimal care coordination can
compromise patient care and increase overall program spending. A
commenter noted younger dually eligible individuals face health
inequities caused by institutional racism and other systematic
disadvantages. A few commenters encouraged full integration and MACPAC
cited recent Bipartisan Policy Center reports \12\ urging full
integration of Medicare and Medicaid services for all full-benefit
dually eligible individuals. Another commenter emphasized that coverage
of medical, behavioral health, and long-term services and supports
should be aligned and integrated care should be grounded in the
diversity of dually eligible enrollees, tailored to individuals' needs
and preferences, prioritize care coordination, simplify eligibility and
enrollment processes, minimize administrative burdens, and honor
enrollee choice of plan and providers.
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\12\ Bipartisan Policy Center, Guaranteeing Integrated Care for
Dual Eligible Individuals (2021) and A Pathway to Full Integration
of Care for Medicare-Medicaid Beneficiaries (2020).
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Response: We appreciate the comments and we agree that a fragmented
delivery system raises major issues, as we discussed in the proposed
rule (87 FR 1849 through 1850). We are committed to maximizing
opportunities for integration through the proposals finalized in this
rule and will continue to explore additional ways to better align the
Medicare and Medicaid programs in the future. We acknowledge the
comment about dually eligible individuals experiencing health
inequities caused by institutional racism and other systematic
disadvantages. Addressing such inequity is a major focus of CMS and
other Federal agencies, based in part on Executive Order 13985 on
Advancing Racial Equity and Support for Underserved Communities Through
the Federal Government (January 20, 2021).
Comment: Numerous commenters supported the overall focus of the
proposals to better integrate Medicare and Medicaid services,
incrementally strengthen and improve integration for D-SNPs, advance
health equity, and improve the beneficiary experience for older adults
and people with disabilities. A few commenters indicated these
proposals improve the potential for D-SNPs to provide person-centered
care and support enrollees to remain independent and manage their
health and daily activities. A few commenters indicated the proposals
provide States with greater D-SNP coordination and oversight
opportunities.
A few commenters believed the proposals would tighten and clarify
requirements for D-SNPs. A commenter indicated the proposals would help
simplify D-SNP offerings, and another commenter noted support for the
proposed rule's goal of strengthening consumer protections to ensure
dually eligible individuals have access to accurate and accessible
information about health plan choices and benefits. A few commenters
believed the proposals would help engage enrollees in designing and
participating in care. Another commenter indicated the proposals offer
the potential for both administrative and clinical integration at the
plan level.
A commenter encouraged CMS to couple implementation of the final
rule with guardrails to mitigate against potential unintended
consequences. Another commenter encouraged CMS to quickly adopt
regulations that reflect stakeholder recommendations in light of the
rapid growth of D-SNPs.
Several commenters expressed support for the package of D-SNP
proposals as useful incremental steps toward furthering integrated care
via D-SNPs. A commenter encouraged CMS to consider how steps taken now
build towards a broader long-term vision for integrated care. Another
commenter acknowledged that CMS did not want to be prescriptive but
encouraged CMS to provide sufficient detail with regard to the array of
D-SNP proposals when finalizing the rule given the recent growth in the
D-SNP landscape.
Response: We appreciate the widespread support for our proposals.
As discussed in the proposed rule (87 FR 1850), these proposals build
on two recent MA/Part D rulemakings and our experiences with MMP
policies. We believe this final rule will further 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.
As we discuss later in this section under specific proposals, we
will provide technical assistance, monitor implementation of the
finalized provisions, and consider future rulemaking as needed to
address any identified areas of concern. For example, information from
CMS audits will help us monitor the extent to which MA organizations
are meeting the enrollee advisory committee requirements at Sec.
422.107(f), and we may consider more prescriptive requirements, as
needed, based on implementation experience.
We acknowledge the request for additional detail related to some of
the D-SNP proposals. As we discuss in response to comments on specific
[[Page 27717]]
proposals later in this section, we aim to strike a balance between
providing MA organizations with flexibility in implementing various
finalized requirements versus being more prescriptive. We explain our
rationale further in responses to comments, including related to
requirements for enrollee advisory committees at Sec. 422.107(e), SDOH
questions in SNP HRAs at Sec. 422.101(f)(1)(i), and limited carve-outs
of Medicaid behavioral health services and long-term services and
supports (LTSS) at Sec. 422.107(g) and (h).
Comment: A number of commenters commended CMS for applying lessons
learned from MMPs to D-SNPs and providing a long-term strategy for D-
SNPs as an integrated plan option. A few commenters stated that the MMP
demonstrations created a gold standard for integrated care and have
given beneficiaries avenues for providing input on plan operations
though beneficiary advisory committees; enhanced the beneficiary
experience through integrated communications materials; scaled up
person-centered care planning and care coordination including
effectively combining medical and behavioral health benefits; and
delivered a platform for incentivizing innovation and investment to
improve quality of care for dually eligible individuals. Several
commenters noted the achievements of particular States and MMPs in the
FAI and expressed appreciation for the CMS goal of establishing a more
permanent mechanism to sustain integrated programs beyond the
demonstrations.
MACPAC expressed support for CMS for proposals to promote
integration by applying features of the MMPs operating under the FAI to
D-SNPs. MedPAC encouraged CMS to extend some of the proposals that
promote integration to HIDE SNPs too. A few commenters acknowledged the
role of nonmedical benefits in providing care to complex populations
and expressed appreciation for flexibilities in payment and benefit
design.
Response: We thank the commenters for the support for the proposals
that incorporate many of the early lessons learned from the MMP
experience into the broader MA program. We believe doing so will
improve experiences for dually eligible individuals.
Comment: A few commenters expressed support for the work of the CMS
Medicare-Medicaid Coordination Office (MMCO) to improve care for dually
eligible individuals, address needs around integration of care, focus
on social determinants of health, and promote equity, while another
commenter noted appreciation for MMCO efforts to lower health care
costs for beneficiaries, States, and Federal Government.
Response: We thank commenters for their support.
Comment: Several commenters noted that Federal support would be an
important component to helping States implement the necessary changes
and to facilitate further integration of D-SNPs. These commenters noted
that State officials often struggle with competing priorities, limited
Medicare knowledge, and limited staff capacity to develop and implement
integrated care initiatives for dually eligible individuals relative to
their other responsibilities. A few commenters acknowledged the wide
range of technical assistance that CMS has provided to date to help
navigate the complexities of the policy environment and expand State
ability to integrate and encouraged CMS to continue to bolster these
resources for States should the proposals in this rule become final.
Other commenters recommended that States would need additional Federal
funding to enhance State capacity and to further incentivize
integration.
Response: We thank the commenters for this feedback and agree that
States are an important partner in implementing many of the D-SNP
proposals in this rule. We are committed to continue working closely
with States to support their integration efforts and intend to utilize
and build from the technical assistance resources we already have in
place, including the Integrated Care Resource Center (see <a href="https://integratedcareresourcecenter.com">https://integratedcareresourcecenter.com</a>).
Comment: A few commenters noted the importance of robust oversight
to ensure that policies do not lead to higher spending without actually
benefiting people with Medicare and supported the increased oversight
of D-SNPs contained within the proposed rule. A commenter expressed
concern as to whether there was sufficient demographic data, especially
on disability and on social, racial, and economic status, or data on MA
supplemental benefit spending, access, and eligibility for such
oversight. Another commenter expressed concern that the Federal
Government lacks the capacity to conduct adequate oversight without
sharing responsibility with States.
Response: We thank the commenters for these comments. We agree that
oversight is an important component of providing person-centered, high
quality care and will continue to work with stakeholders to ensure
integrated programs do just that. We will consider opportunities for
improving the types and quality of available data necessary to support
such oversight in the future. We address issues related to expenditure
data on MA supplemental benefits as part of MLR reporting in section
II.G of this final rule.
Comment: A few commenters supported the focus on the D-SNP model
for deepening integration, pointing out the widespread availability and
growing enrollment in D-SNPs and the ongoing investments by plans and
States in supporting infrastructure. The commenter indicated the
provisions included in the proposed rule were a logical alternative to
other more radical integration proposals. A commenter specifically
appreciated CMS's focus on the experience of D-SNP enrollees given the
large number of enrollees in D-SNPs in certain States and the health
care needs of these individuals.
Response: We thank the commenters for this feedback. As we
discussed in the proposed rule at 87 FR 1888, the integrated care
landscape has changed substantially over the last 10 years. Key changes
include Congress making D-SNPs permanent, establishing new minimum
integration standards, and directing the establishment of unified
appeals and grievance procedures. Changes in MA policy have also
created a level of benefit flexibility that did not previously exist
outside of the capitated model demonstrations, with MA plans
increasingly offering supplemental benefits that address social
determinants of health and LTSS. These changes make D-SNPs an
attractive vehicle for integration for dually eligible individuals.
Comment: A few commenters stated that the proposals do not go far
enough to further integrated care. A commenter stated that the proposed
changes do not address the main factors that determine long-term
beneficiary satisfaction with integrated care, such as access to
providers, easily understood marketing or other materials to help
inform beneficiaries of their choices, and access to supplemental
benefits. Another commenter stated that while the proposed policy
changes promote integration in existing products, they do not
necessarily increase the availability of integrated models or
enrollment in integrated plans.
Response: We appreciate the feedback from these commenters. We
believe several of our proposals address factors that determine
beneficiary satisfaction--see, for example, our proposal at Sec.
422.107(e) related to using specified integrated materials--but we
appreciate that there remain many other
[[Page 27718]]
opportunities to improve experiences for dually eligible beneficiaries.
We will consider whether there are additional opportunities to address
these issues in the future.
Comment: A few commenters supported the overall effort to promote
care integration for dually eligible individuals but expressed concern
about the potential for increased administrative burden for State
Medicaid agencies, disruptions in care for members, and other
operational challenges. A commenter expressed concern that some of the
proposals would significantly curtail States' ability to customize
programs that meet the specific needs of their State programs and
constituents. Another commenter noted that the proposals are likely to
be most impactful for States that are relatively far along in their
integrated care strategies and recommended CMS continue its efforts
through the Medicare-Medicaid Coordination Office and the Integrated
Care Resource Center to promote integration for States newer to this
policy area. A commenter was concerned that the operational aspects of
some of the provisions would disadvantage new entrants to the MA
market, particularly those that target underserved populations. Another
commenter emphasized that CMS has an opportunity to ensure States do
not use the proposed changes to hinder new market entrants who may
offer more and better service to beneficiaries.
Response: We thank the commenters for these comments and
acknowledge the concerns they raise. It is important to note that none
of the provisions in the proposed rule would impose new requirements on
States; rather, States may choose whether or not to take advantage of
any of the proposals finalized here. We are committed to continue
working closely with States to support their integration efforts,
regardless of how far along they are, and intend to utilize and build
from the technical assistance resources we already have in place,
including the Integrated Care Resource Center. While some proposals
would impose new requirements of D-SNPs, we think on balance, the
advantages of increasing the overall level of integration outweigh the
potential downsides.
Comment: A commenter recommended allowing MA organizations to offer
D-SNPs without holding a Medicaid contract either directly or between
the parent company and the State Medicaid agency.
Response: We note that while State contracting policies may have
prevented sponsors from offering D-SNPs in some markets, section
1859(f)(3)(D) of the Act requires a D-SNP to have a contract with the
applicable State Medicaid agency. States are authorized to determine
which D-SNPs they will contract with, as described in section 164 of
the Medicare Improvement for Patients and Providers Act (MIPPA) (Pub.
L. 110-274), which amended section 1859(f) of the Act to add the
requirement for D-SNPs to have a contract with the State.
Comment: A commenter recommended that CMS further define terms such
as care coordination, person-centered care, and integrated care. This
commenter believes further definition of these terms is important to
gain trust among dually eligible individuals, especially those between
the ages of 21 and 65 years old.
Response: An important theme of our proposals is to improve
experiences for dually eligible beneficiaries who are enrolled in D-
SNPs. As part of that, we aim to streamline and simplify operations,
including the terminology we use. We appreciate these suggestions and
will consider them for the future. We believe that the terms care
coordination, person-centered care, and integrated care are
sufficiently clear in this final rule that additional regulatory
definitions are not necessary.
3. Enrollee Participation in Plan Governance (Sec. 422.107)
We believe managed care plans derive significant value from
engaging enrollees in defining, designing, participating in, and
assessing their care systems.\13\ 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.\14\ As described at 87 FR 1855 through 1856 of the
proposed rule, Federal regulations for other programs, such as the
Programs of All-Inclusive Care for the Elderly (PACE) and Medicaid
managed care plans that cover LTSS include requirements for stakeholder
engagement and committees, including input from beneficiaries.
---------------------------------------------------------------------------
\13\ 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>.
\14\ 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>.
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As required by the three-way contracts between CMS, States, and
MMPs, all MMPs established enrollee advisory committees. As described
at 87 FR 1854 through 1855 of the proposed rule, 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.
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 proposed 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 proposed 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 proposed 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 contract 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
[[Page 27719]]
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 and that this requirement is therefore necessary and
appropriate.
While we described 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 noted 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 to have a member advisory committee when LTSS are covered under a
Medicaid managed care plan's contract.
First, we proposed 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.
As proposed, 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 proposed 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. At 87 FR 1856 of the proposed
rule, we explained that, by using the phrase ``representative sample''
in the regulation text, we intended that D-SNPs 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. For MA organizations
that offer separate D-SNPs serving full-benefit dually eligible
individuals and partial-benefit dually eligible individuals in the same
State, we explained that our proposal would provide flexibility for MA
organizations to solicit enrollee input through one or more committees
where separate committees might represent specific eligibility groups.
Finally, we proposed 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). Our proposal did not
specify other responsibilities or obligations for the committee, but we
encouraged D-SNPs to solicit input from enrollees on other topics would
be part of the committee's responsibilities.
At 87 FR 1857 of the proposed rule, we described how our proposal
would relate to the requirement at Sec. 438.110 for Medicaid managed
care plans that cover long-term services and supports and how some
organizations may satisfy our proposed requirement at Sec. 438.110
with the same advisory committee.
Citing our belief that D-SNPs should work with enrollees and their
representatives to establish the most effective and efficient process
for enrollee engagement, we did not 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. However, we solicited comments on 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 committee
responsibilities, additional committee topics, and whether we should
limit the enrollee advisory committee proposed at Sec. 422.107(f) to a
subset of D-SNPs. We also solicited 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. We noted that, if our proposal were finalized, we would
update the CMS audit protocols for D-SNPs to request documentation of
enrollee advisory committee meetings.
Comment: Numerous commenters expressed strong support for our
proposal to require that an MA organization offering one or more D-
SNP(s) in a State have one or more enrollee advisory committees that
serve the D-SNP(s) offered by the MA organization in that State. Many
of these commenters noted direct input from enrollees helps to improve
plan quality, operations, and care coordination to better serve its
enrollees and can help advance health equity among dually eligible
individuals. A number of commenters stated that their support for our
proposal was informed by their experience with enrollee advisory
committees implemented by MMPs, Medicaid managed care plans, and D-
SNPs. Numerous commenters suggested that engagement of enrollees
representing the diversity of the dually eligible population in a State
is essential to providing meaningful person-centered care and
effectively coordinating and integrating care across Medicare and
Medicaid services in a manner that reflects individual's needs and
preferences. A commenter shared their experience implementing D-SNP
enrollee advisory committees, noting these committees are a chance to
build trust with enrollees, improve plan processes, address health
equity barriers, and empower enrollees as active contributors and co-
designers of programs and policies. Some commenters appreciated that
our proposal builds on existing Federal regulations that require
enrollee advisory processes among Medicaid LTSS managed care plans and
PACE and similar requirements for MMPs, which would create fewer
differences for State staff managing multiple integration efforts and
preserve flexibility in the design of these committees. MACPAC
expressed its support for the proposal and welcomes CMS modeling the
structure after the MMP committees to include beneficiaries, families,
and other caregivers. Some commenters viewed the proposed committee
requirement as an opportunity for States to cross-pollinate committee
input and activities across D-SNPs that operate in their State. Other
commenters appreciated the proposed requirement for the committee to
encompass a representative sample of D-SNP enrollees within a State and
noted that, because of this requirement, plans constructing these
committees would take efforts to recruit participants from the diverse
backgrounds of their enrollees.
Response: We appreciate the widespread support we received for our
proposal. These comments bolster our belief that the establishment and
maintenance of an enrollee advisory
[[Page 27720]]
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. We agree that the requirement that D-SNPs include a
reasonably representative sample of members will incentivize them to
consider diversity when recruiting for their enrollee advisory
committees.
Comment: A commenter applauded CMS's effort to create more
mechanisms for enrollee input in plan operations and consult enrollees
on issues related to health equity. But, this commenter believed
requiring each SNP to establish and maintain a separate advisory
committee could be redundant and duplicative with existing efforts. The
commenter offered the example that, in many regions, coalitions or
community groups already exist that can provide input on enrollee needs
and stated that in some cases the existing coalitions or community
groups are already prepared to inform plans about the challenges that
impact their enrollees. This commenter recommended that CMS require all
SNPs to have a mechanism to obtain diverse and representative enrollee
input on plan policy and operations rather than requiring all D-SNPs to
use the specific mechanism of enrollee advisory committees. Further,
the commenter suggested that where community groups do not already
exist, plans could then establish their own enrollee advisory
committees.
Response: We thank the commenter for this perspective. We would
like to take the opportunity to clarify that our proposal would not
apply to all SNPs but MA organizations with one or more D-SNPs in a
State. While C-SNPs and I-SNPs could benefit from enrollee advisory
committees and the type of engagement described by the commenter, and
we encourage them to do so, we are not requiring it at this time. Our
experience with such committees has been concentrated on plans
exclusively or mainly enrolling dually eligible individuals, so we have
chosen to apply this requirement to D-SNPs. Based on the D-SNP
experience with such committees, we may consider future rulemaking to
consider such a requirement for C-SNPs and I-SNPs.
We recognize that coalitions and groups serving local communities
can offer helpful perspectives to MA organizations and D-SNPs and our
proposal does not preclude MA organizations and D-SNPs from engaging
with other parties to gather feedback. But, 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, which is 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.
Comment: Several commenters requested technical assistance for MA
organizations and D-SNPs to help establish the proposed enrollee
advisory committees. A few of these commenters stated that establishing
robust enrollee advisory committees can be challenging. A commenter
emphasized that the existence of an advisory committee is not itself a
demonstration of enrollee input, but that these committees must be
intentionally designed, integrated into overall program structures to
be considered true enrollee engagement, and have decision-making
authority. Another commenter requested that CMS provide technical
assistance and guidance documents and/or training to plans, States, and
consumer advocates on effective and standardized practices for these
committees. A commenter suggested CMS leverage two existing resources
on the topic of consumer engagement in enrollee advisory committees as
technical assistance for plans regarding how to build a meaningful
advisory committee.\15\
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\15\ Community Catalyst, ``Meaningful Consumer Engagement: A
Toolkit for Plans, Provider Groups and Communities,'' March 2014.
Retrieved from <a href="http://www.advancingstates.org/hcbs/article/meaningful-consumer-engagement-toolkit-plans-provider-groups-and-communities">http://www.advancingstates.org/hcbs/article/meaningful-consumer-engagement-toolkit-plans-provider-groups-and-communities</a>; and Community Catalyst, ``Supporting Meaningful
Engagement through Community Advisory Councils,'' August 2020.
Retrieved from: <a href="https://www.healthinnovation.org/resources/publications/supporting-meaningful-engagement-through-community-advisory-councils">https://www.healthinnovation.org/resources/publications/supporting-meaningful-engagement-through-community-advisory-councils</a>.
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Response: We welcome this feedback and agree that technical
assistance to support the design and implementation of enrollee
advisory committees is important. CMS's contractor Resources for
Integrated Care partnered with Community Catalyst, a non-profit
advocacy organization, and offered a series of webinars and other
written technical assistance to help enhance MMPs' operationalization
of these committees in 2019.\16\ In the proposed rule at 87 FR 1855, we
outlined some of the best practices leading to successful enrollee
advisory committees. We also noted in the proposed rule (87 FR 1888)
that we intend to continue--focusing now on D-SNPs--many of the
technical assistance and quality improvement activities that we
initially developed for MMPs, including--
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\16\ Resources for Integrated Care and Community Catalyst,
``Member Engagement in Plan Governance Webinar Series'', 2019.
Retrieved from: <a href="https://www.resourcesforintegratedcare.com/article/member-engagement/">https://www.resourcesforintegratedcare.com/article/member-engagement/</a>.
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<bullet> Learning communities;
<bullet> Direct work with beneficiary advocates and other
stakeholders;
<bullet> Targeted efforts to improve outcomes and reduce
disparities; and
<bullet> Capacity building on topics like person centeredness,
disability-competent care, dementia, and behavioral health.
We expect these topics to also include a focus on enrollee advisory
committees.
Comment: We received numerous comments in favor of more
prescriptive requirements and numerous comments in favor of a less
prescriptive approach consistent with our proposal.
Among those in favor of more prescriptive requirements, numerous
commenters requested that we provide clarification or further
requirements on selection processes for enrollee advisory committees
and what we consider to be a reasonably representative sample of the
population enrolled in the D-SNP. Several commenters suggested that a
reasonably representative sample should include enrollee
characteristics such as race, ethnicity, language, disability status,
sexual orientation and gender identity, receipt of LTSS or behavioral
health services, geography and service area. A few commenters suggested
that we establish percentage thresholds, such as a majority of
committee participants are dually eligible individuals or a majority of
participants are non-white or non-English speaking. A commenter
recommended that enrollee advisory committees be composed of a majority
of participants based on the proportional representation of enrollees
with lived experiences and demographic identities, including
disability, while other commenters requested we provide specific
[[Page 27721]]
parameters on how D-SNPs might meet the definition of ``representative
sample''. Some commenters requested that we specify a minimum number of
participants for the enrollee advisory committees. A commenter
recommended that CMS establish a threshold for volume of D-SNP
enrollees that a single committee could represent, suggesting one
committee per D-SNP or per a certain number of D-SNP enrollees across
plans (for example, 20,000). This commenter also recommended that D-
SNPs be required to notify eligible enrollees of the opportunity to
participate. Another commenter suggested we relax the representative
sample requirement, as it is difficult for D-SNPs to engage all
populations enrolled to include representation on advisory committees.
Another commenter requested that CMS direct MA organizations to
work with stakeholders, such as patient advocacy groups, to ensure
enrollee advisory committees include a diverse and comprehensive
patient population. MACPAC expressed that these committees should be
developed by plans in partnership with advocates and should be
representative of the people served by integrated programs. A few
commenters noted that CMS should require D-SNPs to allow caregivers,
personal care attendants, interpreters, and others to attend to help
enrollees participate.
In making its case for more prescriptive requirements, a commenter
remarked that an analysis of MMP advisory committees indicates that,
despite requirements in most States that committee membership reflects
the diversity of the member body, the lack of guidance on what
diversity means or how to properly recruit leads to under-
representation of minority enrollees in committees. According to the
commenter, not defining ``reasonable sample'' of individuals enrolled
in D-SNPs increases the risk that the committee does not adequately
represent the D-SNP enrollees.
Response: We appreciate the commenters' suggestions for additional
specificity in requirements for establishing enrollee advisory
committees for MA organizations with one or more D-SNPs in a State.
Given the variation in State Medicaid program, D-SNPs, and dually
eligible populations across States and localities and the existence of
enrollee advisory committees established under Sec. 438.110, we
continue to believe that D-SNPs should work with enrollees and their
representatives to establish the most effective and efficient process
for enrollee engagement.
We appreciate comments regarding the need for more prescriptive
requirements with respect to enrollee advisory committee diversity, and
the need to more specifically define a reasonable sample of D-SNP
enrollment such that committee representation is an accurate reflection
of overall enrollment. We recognize that a key finding from the 2019
report ``The Role of Consumer Advisory Councils in the Financial
Alignment Initiative'' \17\ was the need for improved diversity of
enrollee advisory committee participation. The first annual report for
the Massachusetts Financial Alignment Initiative demonstration found
that attracting and retaining diverse stakeholder participation in the
Implementation Council was a challenge.\18\ The second annual report
indicated the Implementation Council was able to recruit additional
members, and one Implementation Council member noted that ``the
resulting diversity was both exciting and challenging''.\19\ While we
are choosing to be nonprescriptive in how a reasonable sample is
defined for the purposes of our new requirement, we may consider more
prescriptive requirements based on information regarding how MA
organizations implement committees and comply with the requirement that
the D-SNP enrollee committees be reasonably representative of the
enrolled population. Future technical assistance will include promising
practices for how plans can build a diverse committee membership.
---------------------------------------------------------------------------
\17\ Center for Consumer Engagement in Health Innovation, ``An
Exploration of Consumer Advisory Councils within Medicare-Medicaid
Plans Participating in the Financial Alignment Initiative'', 2019,
Retrieved from: <a href="https://www.healthinnovation.org/resources/publications/an-exploration-of-consumer-advisory-councils-within-medicare-medicaid-plans">https://www.healthinnovation.org/resources/publications/an-exploration-of-consumer-advisory-councils-within-medicare-medicaid-plans</a>.
\18\ RTI, ``Financial Alignment Initiative Annual Report: One
Care: MassHealth Plus Medicare, First Annual Report,'' September
2016 (updated July 2017). Retrieved from: <a href="https://innovation.cms.gov/files/reports/fai-ma-firstevalrpt.pdf">https://innovation.cms.gov/files/reports/fai-ma-firstevalrpt.pdf</a>.
\19\ RTI, ``Financial Alignment Initiative: Massachusetts One
Care Second Annual Report,'' April 2019. Retrieved from <a href="https://innovation.cms.gov/files/reports/fai-ma-secondevalrpt.pdf">https://innovation.cms.gov/files/reports/fai-ma-secondevalrpt.pdf</a>.
---------------------------------------------------------------------------
Comment: We received some comments from organizations requesting
that we specify how often the enrollee advisory committees must meet. A
few of these commenters encouraged CMS to establish minimum frequency
requirements but did not specify a meeting interval. Several commenters
recommended that we require enrollee advisory committees to meet at
least twice per year, and a commenter suggested quarterly convenings. A
few of these commenters expressed concern that, without a minimum
required frequency, plans would opt for annual meetings, which the
commenters indicated would have limited value.
A few commenters encouraged CMS to set training requirements for MA
organizations and D-SNPs as they establish these committees. A
commenter emphasized that CMS require D-SNPs to establish a process to
train D-SNP staff on collecting and incorporating advisory committee
feedback into plan operations and informing participants how enrollee
feedback was used. We also received a comment that States should be
given the authority to specify and require training components as part
of their contracting with plans.
Some commenters encouraged CMS to provide more specifics related to
training for enrollee advisory committee participants. A few of these
commenters recommended requirements to ensure MA organizations educate
enrollee advisory committee participants about the responsibilities of
these committees and ways to meaningfully engage in them, including
providing an understanding of D-SNP program design and organizational
structure. A commenter suggested that CMS include a requirement that
the enrollee advisory committee receives training on key health and
health care disparity concerns that affect the population served by the
D-SNP and a robust module be provided on disability inclusion in health
care, emphasizing intersectional identities. This commenter also
suggested that D-SNPs provide the committee basic information about the
right to request reasonable accommodations and policy modifications, an
overview of the D-SNPs' transparency and accountability mechanisms, and
local and State agencies and commissions with overlapping
responsibilities and interests. A few of the commenters suggested that
CMS create standards for training processes but did not provide further
details.
A few commenters suggested that CMS require enrollee advisory
committees to incorporate other parameters. A commenter recommended
that enrollees, not State authorities, should lead the committee
process. Another commenter stated that CMS should consider other
required feedback mechanisms for enrollee input beyond the proposed
committee structure, which--in their view--could have a limited number
of participants or may not include those who have voiced concerns about
the plan. Another commenter suggested that CMS require MA organizations
to implement best
[[Page 27722]]
practices to ensure enrollee advisory committee participant retention
and equity.
A few commenters urged CMS to issue additional sub-regulatory
guidance concerning its expectations of MA organizations and D-SNPs in
establishing these enrollee advisory committees.
Some commenters suggested specific topics the committee should be
required to focus on beyond the health equity topic included in the
proposed rule. A few commenters recommended that the committees focus
on concerns and priorities of the enrollees themselves. A commenter
supported additional topics be shared with committee participants for
their input but did not name any particular topics. Another commenter
did not specify any additional topics but suggested that the D-SNPs
provide information to alert the enrollee advisory committee
participants of the scope of potential topics, such as through a non-
exhaustive list of topics other advisory committees have tackled. A few
additional commenters identified specific topics for consideration,
such as medication adherence, D-SNP collection of self-identified
functional limitation data, and addition of self-identified functional
limitation data fields to electronic patient records.
Response: We appreciate the commenters' suggestions for additional
specificity in requirements for establishing enrollee advisory
committees. We continue to believe that giving D-SNPs flexibility in
structuring the enrollee advisory committees will permit D-SNPs--and
the enrollees participating on the advisory committees--to tailor these
committees based on the local needs of enrollees. As we stated in the
proposed rule, 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. 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 are
not finalizing any additional Federal requirements as to the specific
frequency, location, format, participant recruiting and training
methods, or other parameters for these committees beyond certain
minimum requirements; however, we may consider more prescriptive
requirements in future rulemaking based on D-SNP experience with
enrollee advisory committees.
Comment: Numerous commenters emphasized the importance for
transparency of these enrollee advisory committees and ensuring D-SNPs
are held accountable for adhering to established requirements. Several
commenters suggested that MA organizations create a feedback loop for
advisory committees to see how their feedback is being considered and
implemented and to share this information with enrollee advisory
committee participants. A few commenters welcomed information on how
CMS would evaluate the effectiveness of the enrollee advisory
committees, including any expected measurable outcomes, to better
understand how well the committees are achieving policy goals. Another
commenter requested that CMS consider whether there may be additional
Federal and State benefits to compiling the findings of these enrollee
advisory committees since this information may help inform future
policy duration for not only MA plans and SNPs but also for the
original Medicare FFS program.
Response: We appreciate the request for monitoring of enrollee
advisory committees against the requirements outlined at Sec.
422.107(f) and the interest in information gathered through these
convenings. We are not requiring that MA organizations publicly
distribute enrollee advisory committee meeting agendas or materials
since these committees will be addressing challenging topics related to
plans and their enrollees, including potentially market-sensitive
information related to potential changes in future plan benefits. We
are concerned that requiring plans to make these agendas and materials
publicly available could interfere with committee effectiveness. We
noted in the proposed rule that, if our proposal were finalized, we
would update the CMS audit protocols for D-SNPs to request
documentation of enrollee advisory committee meetings. Information from
CMS audits will help us monitor the extent to which MA organizations
are meeting the enrollee advisory committee requirements at Sec.
422.107(f), and we may consider more prescriptive requirements, as
needed, based on implementation experience.
Comment: Numerous commenters supported the flexibility CMS offered
in the structure of the proposed enrollee advisory committees and urged
CMS to require a less prescriptive approach to the enrollee advisory
committees, consistent with the proposed rule. Many of these commenters
favored a minimum set of requirements to give D-SNPs the flexibility to
implement and manage enrollee advisory committees that best meet the
needs of the local population and obtain meaningful input. Several
commenters stated that the design flexibilities encourage the
development of enrollee advisory committees to best reflect the
different types of D-SNPs (that is, fully integrated dual eligible
(FIDE) SNPs, highly integrated dual eligible (HIDE) SNPs, coordination-
only D-SNPs \20\) currently in place and the complexity of the dually
eligible populations enrolled, which can differ from one locale to
another. Some commenters noted that this flexibility would allow plans
that currently offer D-SNPs in multiple States to build a foundation
for an advisory committee that can be modeled and then refined to
address specific needs of populations represented in each committee.
Several commenters urged CMS not to be prescriptive with enrollee
advisory committee requirements, especially for plans that already have
such committees in place. These commenters emphasized that flexible
enrollee advisory committee requirements would allow plans to build on
experience and existing enrollee feedback approaches to best reflect
the nuance and complexity of the D-SNP plans offered and populations
served by those plans. Other commenters noted that this flexibility
allows MA organizations already implementing such committees to
continue existing operations without major changes, and the flexibility
would allow plans to avoid overlapping or duplicative requirements from
CMS and States as well as avoid beneficiary confusion. In supporting
this perspective, a commenter explained that its experience offering
FIDE SNPs, HIDE SNPs, and coordination-only D-SNPs across multiple
States suggested wide variation in the specific benefits covered and
populations served. Another commenter expressed concern that an overly
prescriptive approach would reduce the flexibility for innovation and
could stifle some of the positive strides already underway among
managed care plans.
---------------------------------------------------------------------------
\20\ Coordination-only D-SNPs are D-SNPs that neither meet the
FIDE SNP nor HIDE SNP definitions at Sec. 422.2.
---------------------------------------------------------------------------
Response: We thank the commenters for their perspectives. Based on
our experience with enrollee advisory committees operated by MMPs and
PACE, we believe that D-SNPs should work with enrollees and their
representatives to establish the most effective and efficient process
for the enrollee advisory committees.
[[Page 27723]]
Permitting flexibility for the enrollee advisory committees gives MA
organizations--and enrollees themselves--more opportunity to establish
committees that best meet the needs of enrollees.
State Medicaid agencies have broad authority to include more
prescriptive parameters for enrollee advisory committees in their
contracts with D-SNPs and could adopt some of the commenters'
suggestions appropriate to their State through these State Medicaid
agency contracts. As discussed in the proposed rule at 87 FR 1857, some
State Medicaid agencies already do this in applying Sec. 438.110.
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 \21\ 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. We note that compliance with Federal law
related to accessibility and effective communications for persons with
disabilities is a requirement under other statutes such as Section 504
of the Rehabilitation Act. We also clarify that the enrollee advisory
committees are not meant to preclude MA organizations and D-SNPs from
gathering enrollee feedback through other means. As we discussed at 87
FR 1856, our experience with existing requirements for MMPs and PACE
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.
---------------------------------------------------------------------------
\21\ Resources for Integrated Care and Community Catalyst,
``Engaging Members in Plan Governance'', 2019. Retrieved from:
<a href="https://www.resourcesforintegratedcare.com/article/member-engagement/">https://www.resourcesforintegratedcare.com/article/member-engagement/</a>.
---------------------------------------------------------------------------
Comment: Some commenters requested that CMS clarify what
documentation we will request as part of CMS audit protocols with
respect to enrollee advisory committees. Other commenters suggested we
audit enrollee advisory committees on the accuracy of committee
representation of the D-SNP enrollee membership, meeting frequency and
committee feedback to the D-SNP.
Response: Information requested as part of the CMS audit protocols
may be similar to that reported by MMPs as part of the reporting
requirement (for example, dates of meetings held, number of enrollees
invited, number of enrollees in attendance). As described in section
IV.B.1.b., prior to implementation of new audit protocols (under OMB
control number 0938-1395; CMS-10717), we will make them available to
the public for review and comment under the standard PRA process, which
includes the publication of 60- and 30-day Federal Register notices.
Comment: Several commenters questioned whether D-SNPs could
delegate the facilitation or operation of enrollee advisory committees
to first tier, downstream, or related entities.
Response: There is nothing in rule that precludes a D-SNP from
delegating the facilitation or operation of an enrollee advisory
committee to a first tier, downstream, or related entity.
Notwithstanding any relationship(s) that the D-SNP has with first tier,
downstream and related entities, the MA organization maintains the
ultimate responsibility for adhering to and otherwise fully complying
with all terms and conditions of its contract with CMS, per Sec.
422.504(i). All requirements with respect to the enrollee advisory
committee are still applicable in the event a D-SNP delegates
facilitation or operation of the enrollee advisory committee.
Comment: In addition to D-SNP enrollee advisory committees, some
commenters recommended CMS require States to create centralized, cross-
plan advisory councils, similar to the implementation councils
currently in place for the Massachusetts and Rhode Island
demonstrations under FAI. Commenters suggested these councils be
comprised of majority of D-SNP enrollees and their caregivers, and
expressed that such councils could provide additional transparency and
insight into D-SNP policy and operations. A commenter suggested CMS
provide Federal funding for these State-level advisory councils, and
another commenter suggested an implementation council was best
positioned to liaise and collaborate with other similar health services
and LTSS/HCBS (home and community-based services) county and State-
level committees including Olmstead committees, Money Follows the
Person advisory committees, and Medicaid advisory committees.
Response: While we acknowledge the utility of a centralized
advisory council, and commend the important work of the Massachusetts
One Care Implementation Council in particular, we defer to States to
decide whether to implement broader advisory councils in order to
solicit feedback more broadly on their Medicaid managed care programs
and the D-SNPs that operate in the State.
Comment: A commenter opposed the approach of allowing MA
organizations to meet the requirements proposed in Sec. Sec.
422.107(f) and 438.110 through one enrollee advisory committee,
acknowledging that, although there is overlap in the enrollees served,
there are important distinctions in the populations and topics relevant
for each stakeholder group.
Response: While we appreciate the commenter's perspective that
there are important distinctions in the populations served, and that
there may be distinct topics for each group, there may also be
instances in which populations align and therefore separate enrollee
advisory councils may be duplicative. We believe the best approach is
to be nonprescriptive and allow one enrollee advisory committee to
satisfy both requirements in the instances in which the minimum
requirements for Sec. Sec. 422.107(f) and 438.110 are both met. States
may choose to apply distinct requirements via their State Medicaid
agency contracts and their Medicaid managed care contracts, such that
plans would need distinct enrollee advisory committees for different
plan populations.
Comment: Many commenters suggested we delay the implementation of
the enrollee advisory committee provision to contract year 2024 or
suggested a phased-in approach that would require FIDE and HIDE SNPs to
implement the enrollee advisory committees starting in contract year
2023, with less integrated D-SNPs implementing in contract year 2024.
Commenters indicated the need for additional time to develop outreach
strategies, coordinate with States, and develop reasonable
representation recruitment strategies. A commenter noted D-SNPs will
need more than a few months to ensure membership represents the
different enrollee perspectives impacted by access, infrastructure,
clinical needs, economic status, and prevalence of social supports.
Response: While we acknowledge commenters concerns around potential
operational challenges to establishing and convening an enrollee
advisory committee, we are nonprescriptive on meeting committee
frequency, location, format, participant recruitment and training
methods. For this reason, we do
[[Page 27724]]
not believe a contract year 2023 implementation timeframe is
unreasonable. Given the implementation timing of this rule, D-SNPs will
have approximately 6 months prior to the effective date of January 1,
2023, to develop an enrollee advisory committee, and we are
nonprescriptive regarding when in calendar year 2023 the committee must
meet, as well as the number of meetings and meeting frequency. Further,
the regulation permits use of one committee per State, allowing for D-
SNPs to start with a single committee and develop more nuanced
committees over time. Additionally, while we have committed to
providing technical assistance to D-SNPs in this area, a number of
resources on establishing meaningful enrollee advisory committees are
currently available via the Resources for Integrated Care.\22\
---------------------------------------------------------------------------
\22\ Resources for Integrated Care ``Engaging Members in Plan
Governance'', Retrieved From: <a href="https://www.resourcesforintegratedcare.com/article/member-engagement/">https://www.resourcesforintegratedcare.com/article/member-engagement/</a>.
---------------------------------------------------------------------------
Comment: Numerous commenters requested clarification on how D-SNPs
could reimburse enrollee advisory committee members for their time and
expertise, and suggested D-SNPs be able to offer stipends,
transportation or transportation reimbursement for in-person meetings,
and food and drink.
Response: We acknowledge the advantages of reimbursing enrollee
advisory committee participants for their time and expertise, and prior
technical assistance in this area \23\ has cited incentives as a best
practice to recruit and retain enrollee advisory committee members. We
clarify that enrollee participation in an advisory committee is neither
a marketing activity nor a personal enrollee health-related activity
that would fall under Sec. 422.134, so the authorities and limits that
are specific to those activities under MA regulations would not apply.
However, MA organizations are prohibited from providing cash, gifts,
prizes, or other monetary rebates as an inducement for enrollment or
otherwise by sections 1851 and 1854 of the Act. D-SNPs should ensure
that any incentives be structured to avoid an inadvertent impact on
enrollee eligibility for public benefits. In addition, the provision of
stipends, transportation reimbursement, or anything else of value to D-
SNP enrollees serving on the enrollee advisory committee potentially
implicates the Federal Anti-kickback Statute (AKS), found in section
1128B(b) of the Act. Whether any particular arrangement violates the
AKS would be based on the specific facts and circumstances. D-SNPs must
ensure that the provision of reimbursement to these members complies
with the AKS and other applicable law. We will provide future technical
assistance to D-SNPs on this issue to help avoid unintended
consequences related to plan compliance or enrollee eligibility for
public programs.
---------------------------------------------------------------------------
\23\ Resources for Integrated Care ``Engaging Members in Plan
Governance'', Retrieved From: <a href="https://www.resourcesforintegratedcare.com/article/member-engagement/">https://www.resourcesforintegratedcare.com/article/member-engagement/</a>.
---------------------------------------------------------------------------
Comment: A number of commenters expressed concerns about
operationalizing an enrollee advisory council for a D-SNP that has low
enrollment. Commenters cited concerns about D-SNPs' ability to meet the
reasonably representative sample if overall plan enrollment is too
small, particularly for a newly established plan or a plan operating in
a rural service area. These commenters suggested CMS either set a
minimum enrollment threshold or allow for advisory committees to cross
geographies (for example, via multi-State consumer advisory councils).
A few commenters recommended we set the minimum D-SNP enrollment
threshold at 1,000 enrollees for the establishment of enrollee advisory
committees. A commenter requested we consider exempting new plans from
this requirement, while another recommended small plans be able to meet
the requirement via focus groups, surveys, or other methods.
Response: While we appreciate the commenters' recommendations with
respect to low-enrollment D-SNPs and the challenges low D-SNP
enrollment might present in operationalizing a consumer advisory
committee, we do not agree that the reasons cited create a significant
barrier for MA organizations to meet the new requirement. First, we
would like to clarify that an 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.
As proposed and finalized here, an MA organization would be able to
choose between establishing a single enrollee advisory committee for
one or more D-SNPs in that State or by establishing multiple committees
in that State to comply with Sec. 422.107(f). Thus, in situations
where an MA organization operates more than one D-SNP in a State, the
MA organization can, unless State Medicaid agency contracts dictate
otherwise, establish one or more committees that encompass multiple D-
SNPs in a State, which should help to address concerns related to low
enrollment in any given D-SNP. Second, a number of MMPs that
participated in FAI had low enrollment (that is, fewer than the
suggested 1,000 enrollee threshold) and were able to operationalize
meaningful enrollee advisory committees. Third, we are nonprescriptive
in this requirement regarding how an MA organization recruits committee
membership, the timing, frequency or number of advisory meetings an MA
organization must conduct in a calendar year, and the meeting's format
(for example, in person or virtual). The reasonably representative
requirement is also sufficiently flexible that small plans can meet the
standard. With this level of flexibility, we believe it is reasonable
for D-SNPs that may have low enrollment to meet the requirements
finalized at Sec. 422.107(f).
Comment: Some commenters asked us to clarify or confirm whether D-
SNPs have the flexibility to convene their advisory councils virtually.
A commenter noted current use of digital platforms, while other
commenters suggested virtual meetings may encourage greater enrollee
participation. A few commenters specifically welcomed the flexibility
in committee format (that is, in-person vs. virtual). A commenter
explained that while in-person meetings remain the gold-standard for
engagement, providing flexibility in how a D-SNP advisory committee
engages with enrollees would help maximize enrollee engagement and
provide flexibility for the D-SNP to evolve its processes as new
effective methods become available.
Response: We are not proposing Federal requirements regarding the
means by which enrollee advisory committees or committee meetings
convene (either in-person or virtually). We confirm that MA
organizations can meet the minimum requirements at Sec. 422.107(f) by
convening meetings virtually, provided they are not restricted from
doing so via their State Medicaid agency contract. However, we
reiterate our encouragement of D-SNPs to adopt identified best
practices to ensure advisory committee meetings are accessible to all
enrollees, including where lack of meaningful access to internet
technology and broadband may limit involvement.
Comment: In the proposed rule, we solicited comments on whether we
should limit enrollee advisory committees to a subset of D-SNPs. A few
commenters agreed that the new requirement should apply to all D-SNPs,
noting it to be the most comprehensive approach to soliciting feedback
from dually eligible enrollees,
[[Page 27725]]
while acknowledging some D-SNPs may already have enrollee advisory
councils that meet the new requirement. A commenter noted that while it
had encouraged applying enrollee advisory committees to FIDE SNPs in
the past, it also supported applying this approach more broadly to all
D-SNPs.
Response: We appreciate the comments of support and we agree that
applying an enrollee advisory committee requirement to D-SNPs broadly,
rather than a subset, is the better mechanism to solicit feedback
directly from enrollees and assist D-SNPs in identifying and resolving
emerging issues. We believe applying this requirement to all D-SNPs,
including those with a low level of integration, is the best approach
to elevate the voice of dually eligible enrollees across a wider array
of States and circumstances.
Comment: To increase transparency, oversight, and accountability, a
few commenters urged State Medicaid agency participation in D-SNP
enrollee advisory councils, or to give States access to the proceedings
and recommendations of the committees on at least a quarterly basis. In
contrast, a commenter suggested the inclusion of State participation on
enrollee advisory councils would add unnecessary complexity.
Response: Nothing in the proposed rule precludes State Medicaid
agencies from requiring, via the State Medicaid agency contracts
required by Sec. 422.107, D-SNPs to include State representatives in
their enrollee advisory council meetings. Additionally, through these
State Medicaid agency contracts, States could require D-SNPs to provide
additional reporting on D-SNP advisory councils as a means for
additional transparency, accountability, and oversight.
Comment: A few commenters suggested CMS allow MA organizations to
establish enrollee advisory committees on a regional or multi-State
basis, to overcome barriers to enrollee participation or when D-SNP
enrollment is small in any single State. A commenter suggested the MA-
PD's enrollee advisory committee within a State include enrollee
representatives of the plans' other Medicare products as another means
to encourage enrollee participation, while another requested to include
Medicaid-only participants on the advisory committee to meet the
existing Medicaid managed care advisory requirement at Sec. 438.110.
Response: Due to the variations in State Medicaid agency contracts
and Medicaid, we believe there is value in keeping enrollee advisory
councils specific to a State. This offers operational simplicity to MA
organizations to meet any State-specific advisory committee
requirements and would improve the effectiveness of an enrollee
advisory committee without combining committee membership across
States, where services, eligibility, and geography could vary greatly.
While we intend this new requirement to generate feedback based on the
unique experience of dually eligible enrollees via a D-SNP enrollee
advisory committee, we recognize that committees may not always be made
up solely of dually eligible enrollees, as organizations can use a
single advisory committee to meet the Medicaid managed care advisory
committee requirement at Sec. 438.110. However, we do not agree that
the enrollee advisory committee should include representatives from
Medicare products that do not focus on dually eligible enrollees. In
meeting the requirement proposed at Sec. 422.107(f), there is nothing
precluding MA organizations from establishing sub-committee
arrangements to established enrollee advisory committees. Also, the
proposed requirement does not preclude non-SNP MA plans from
establishing separate enrollee advisory committees.
Comment: Many commenters indicated that the minimum of a single
Statewide enrollee advisory committee across potentially multiple D-SNP
products was an insufficient approach in larger States, where D-SNPs
may have very large enrollment as well as geographically and
demographically diverse service areas. Commenters noted that a combined
enrollee advisory council in a large State would dilute the value of
the committee. A commenter suggested CMS require each D-SNP to
establish its own committee, and a few commenters requested flexibility
for States to further direct committee geographic scope, composition,
and other factors beyond the Federal minimum requirements, including
the ability to require multiple committees for specific enrollee
populations. Several other commenters asked CMS to clarify whether
enrollee advisory committees need to be at the plan benefit package
(PBP) level. Finally, a commenter expressed that even within a State
and D-SNP parent organization, many D-SNPs have similar plan names and
cover different benefits, which could lead to potential enrollee
confusion if an advisory committee is established Statewide across D-
SNP products.
Response: The new requirement established at proposed Sec.
422.107(f) does not preclude States from using their State Medicaid
agency contracts (as required by Sec. 422.107) to impose more
prescriptive requirements for D-SNP enrollee advisory committees based
on D-SNP enrollment, service area geography, or any other
characteristic. The new proposal does not require D-SNPs to implement
enrollee advisory committees at the PBP level, although they could
choose to do so. States could also require each D-SNP to develop its
own committee, either at the contract or the PBP level. Additionally,
organizations that operate multiple D-SNPs in a State could elect to
establish and maintain multiple enrollee advisory committees that best
represent their eligibility populations (for example, full- or partial-
benefit dually eligible beneficiaries) and/or service areas. We believe
this regulation sets a floor from which States and D-SNPs may work to
craft enrollee advisory committees that best meet local population and
plan needs without committee duplication or significant disruption of
current enrollee advisory committee operations, as required either by
States or Sec. 438.110.
Comment: Many commenters questioned whether D-SNPs could use
existing plan enrollee advisory committees--either FIDE SNP or
committees representing Medicaid managed care plans that cover long
term services and supports--to meet the new proposed requirement at
Sec. 422.107(f). A few commenters asked us to clarify that one
enrollee advisory committee could be used to meet the new requirements
in Sec. Sec. 422.107(f) and 438.110, noting that competing advisory
committees would be inefficient. Another commenter requested we provide
clarity on how the proposal should be implemented with respect to LTSS
and non-LTSS enrollee participants and corresponding council topics.
Other commenters recommended the use of subcommittees (either D-SNP
enrollee advisory committees specific to MLTSS or MLTSS advisory
committee with a subcommittee specific to dually eligible enrollees) as
a potential means to solicit more precise feedback on unique plan
subpopulations.
Response: We acknowledge some D-SNPs, or their affiliated Medicaid
managed care plans covering LTSS, are currently operating enrollee
advisory committees to meet existing State requirements; these existing
committees may satisfy the requirements at Sec. 422.107(f). As we
noted in the proposed rule, our proposal at Sec. 422.107(f) would
permit 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
[[Page 27726]]
proposed at Sec. 422.107(f), when all the criteria in both regulations
are met. However, a State may limit the ability of a D-SNP to use one
committee to meet both regulatory requirements. Finally, nothing in our
proposed requirement would preclude the use of subcommittees with
respect to unique D-SNP subpopulations. As discussed earlier in this
section, we are nonprescriptive on topics (for example, with respect to
LTSS) covered by enrollee advisory committees so long as the minimum
topics specified in the regulation (ways to improve access to covered
services, coordination of services, and health equity for underserved
populations) are addressed; however, we encourage D-SNPs and their
advisory committees to choose topics most relevant to the populations
served.
Comment: Numerous commenters requested we encourage or require D-
SNPs to operate their enrollee advisory committees with accessibility,
accommodations, and communications access in mind for enrollees with
disabilities, as well as enrollees with limited literacy, limited
digital literacy, lack of meaningful access to technology and broadband
and limited English proficiency. Other commenters recommended CMS
require D-SNPs provide interpretation and accommodation for individuals
with hearing and vision disabilities and impairments. Another commenter
recommended CMS require D-SNPs to conduct enrollee advisory committee
meetings in the preferred language of the region/county, when that
region's primary language preference is not English. A commenter noted
the need for committee meeting materials in alternate formats, while
another commenter urged CMS to require D-SNPs to provide accommodations
to committee enrollees who lack transportation or access to the
technology necessary to facilitate robust virtual participation.
Finally, a commenter recommended that CMS provide parameters regarding
the importance of D-SNPs facilitating access to enrollee advisory
committees via training, recruitment, and location and timing of
meetings that reflect the community and population to create a process
that allows enrollees to meaningfully participate in the committee.
Response: We agree with the commenters that it is vitally important
for MA organizations to facilitate meaningful enrollee access to their
enrollee advisory committees through accommodations for their
enrollees' needs in order to achieve a representative sample of
enrollee perspectives and meaningful feedback from the enrollee
advisory committees. Although we are choosing to be nonprescriptive on
meeting frequency, location, format, enrollee recruitment and training
methods, and other parameters, we encourage D-SNPs to adopt identified
best practices to ensure advisory committee meetings are accessible for
all enrollees. Ensuring that the enrollee advisory committee has a
reasonably representative sample of the covered population should
include taking steps to ensure access for enrollees with disabilities,
limited literacy (including limited digital literacy), and lack of
meaningful access technology and broadband, particularly to the extent
that these considerations are also relevant to improving access to
covered services and health equity. Where D-SNPs serve enrollees with
disabilities, limited literacy or limited English proficiency, we
expect those characteristics to be reflected in the D-SNP's enrollee
advisory committee membership. D-SNPs must comply with any applicable
civil rights law. We note that existing Federal civil rights
authorities such as Section 504 of the Rehabilitation Act of 1973, HHS'
implementing regulation at 45 CFR part 84, and Title VI of the Civil
Rights Act of 1964 and the implementing regulation at 45 CFR part 80
would likely apply to an MA organization's administrative functions,
such as enrollee advisory committees. We encourage D-SNPs to also
consider virtual accessibility and transportation accessibility for in
person meetings for their enrollee committee membership.
After considering the comments we received and for the reasons
outlined in the proposed rule and our responses to comments, we are
finalizing without modification our proposed requirement for D-SNPs to
establish and maintain enrollee advisory committees at Sec.
422.107(f).
4. Standardizing Housing, Food Insecurity, and Transportation Questions
on Health Risk Assessments (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 reassessments conducted for each individual enrolled in the plan
are addressed in the individual's 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.\24\ 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 integrated D-SNPs (by which we mean D-SNPs or their
affiliates under the same parent organization also receiving capitation
for Medicaid services) may combine their Medicare-required HRA with a
State Medicaid-required HRA so long as the applicable requirements for
the HRA under Sec. 422.101(f) are met, to reduce assessment burden (86
FR 5879).
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\24\ 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.
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Certain social risk factors can lead to unmet social needs that
directly influence an individual's physical, psychosocial, and
functional status.\25\ This is particularly true for food insecurity,
housing instability, and access to transportation. As summarized in our
proposal rule at 87 FR 1858, CMS in recent years has addressed social
risk through the identification and standardization of screening for
risk factors, including finalizing several standardized patient
assessment data requirements for post-acute care providers \26\ and
testing the Accountable
[[Page 27727]]
Health Communities (AHC) model under section 1115A of the Social
Security Act. The AHC model tests whether systematically screening for
health-related social needs and referrals to community-based
organizations will improve health care utilization and reduce costs,
and includes a CMS Innovation Center-developed AHC Health-Related
Social Needs (HRSN) Screening Tool.\27\
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\25\ 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>.
\26\ 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.
\27\ 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>.
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As discussed in the proposed rule at 87 FR 1858 through 1859, 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.\28\ We posited that
requiring SNPs to include standardized questions about social risk
factors would be 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 would better enable SNPs to design and
implement effective models of care.
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\28\ 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 proposed 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. We noted that these questions
would help SNPs gather the necessary information to conduct
comprehensive risk assessments of each individual's physical,
psychosocial, and functional needs as required at Sec.
422.101(f)(1)(i) and would 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 proposed 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 expressed our intent to provide ample
notice to MA organizations of any changes in the questions over time.
As discussed in the proposed rule, SNPs would comply with the new
requirement added to Sec. 422.101(f) by including in their HRAs the
standardized questions on these topics that we would specify in sub-
regulatory guidance. We described in the proposed rule our intent to,
at a minimum, align selected questions with the Social Determinants of
Health (SDOH) Assessment data element \29\ established as part of the
United States Core Data for Interoperability Standard (USCDI) v2, when
finalized and where applicable.
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\29\ 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 proposed that the regulation text specify that the wording
of individual questions would be established through sub-regulatory
guidance, we provided examples in the proposed rule 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 included the transportation question in the post-acute care
patient/resident instruments \30\ and the housing and food insecurity
questions from the AHC Model HRSN Screening Tool.\31\
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\30\ For more information, see: <a href="https://prapare.org/the-prapare-screening-tool">https://prapare.org/the-prapare-screening-tool</a>.
\31\ 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.
---------------------------------------------------------------------------
As discussed in the proposed rule at 87 FR 1859, 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
HRAs. 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 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 did not propose 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. As explained in the proposed rule at
87 FR 1859, results of the HRAs would 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. We explained that a
SNP could demonstrate this in several ways, consistent with its MOC,
including making referrals to appropriate community partners and taking
steps to maximize access to covered services that meet the individual's
needs.
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 HRAs
to the State or its designee.) In the proposed rule at 87 FR 1859, we
explained that, 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).
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,
[[Page 27728]]
questions in multiple HRAs. As we explained in the proposed rule, we
believe that the benefit gained by all SNPs having standardized
information about these social risk factors outweighs this potential
risk. Where States are interested in requiring assessment questions, we
recommended that States consider conforming to the standardized
questions we implement for use under this final rule and, for
integrated care programs, ensuring that plans do not need to ask the
same enrollees similar or redundant questions. However, we also
solicited 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.
As discussed in the proposed rule at 87 FR 1860, we considered
several alternatives to our proposal. We considered requiring fewer or
more assessment questions on additional topics related to social risk
factors or different combinations of questions, including questions on
health literacy and social isolation. We considered soliciting comment
on different examples of questions on housing, food, and transportation
other than the examples included in the proposed rule. We considered
simply proposing that all HRAs address certain domains (for example,
housing), without authorizing CMS to specify the standardized questions
to be used. We also considered specifying that the new questions only
apply to certain enrollees and not others. We explained our rationale
for not including these alternatives in the proposed rule at 87 FR
1860.
Finally, due to the processes associated with developing HRA tools,
approval of MOCs, and MOC implementation, we discussed applying our
proposed requirement beginning contract year 2024. However, we also
considered 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 solicited comments on our proposal and these potential alternatives.
We also solicited comments on when CMS would need to issue sub-
regulatory guidance providing the specific questions to be included in
the HRAs to ensure that MA organizations would have sufficient time to
incorporate the required questions.
We received the following comments on this proposal and respond to
them below:
Comment: Most commenters expressed support for our proposal to
require all SNPs to include questions on housing stability, food
security, and access to transportation as part of their HRAs. Some
commenters noted that inclusion of questions on these topics in HRAs
would improve insight into enrollee needs. Several commenters stated
that collection of information related to the SDOH can also better
inform plans of enrollees' challenges and reduce barriers to optimal
care and quality of life. A few commenters noted the importance of
SDOH-related information in the development of an individualized,
person-centered care plan. Some commenters expressed appreciation that
CMS's proposal acknowledged the influence of the SDOH on health
outcomes. Several commenters noted that social risk factors have a
significant impact on health outcomes for the SNP population in
particular. Several commenters noted that capturing social risk factors
in SNP HRAs can help plans develop targeted interventions and connect
enrollees to available supplemental benefits. A commenter believed
health plans are best suited to collect this information and have the
necessary resources to connect beneficiaries to social support
services. Another commenter believed awareness of SDOH information
improves care and lowers long-term costs. Other commenters noted that
identifying unmet social needs among SNP enrollees could help reduce
health disparities and advance health equity. A few commenters stated
that that answers to HRA questions help capture information on social
risk factors that is not only useful for individual enrollees, but also
can be curated for evaluation at the population level in a way that can
inform policy changes like payment reform. Another commenter believed
HRA data on social risk factors have the potential to inform SNP
supplemental benefit design and could be useful for incorporating
social risk factors into future risk adjustment.
Response: We appreciate the widespread support for inclusion of
questions on housing stability, food security, and access to
transportation as part of SNP HRAs. We agree that requiring SNPs to
collect information on these topics can allow SNPs to better understand
enrollees' needs and challenges. As we noted in the proposed rule, 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 also appreciate
the commenters' support for reducing health disparities and advancing
health equity more broadly. We agree that better identifying the needs
of SNP enrollees can be an important first step toward these larger
goals.
Comment: A number of commenters expressed support for the three
question topic areas included in the proposed rule (housing stability,
food security, and access to transportation). A commenter recommended
CMS require all three categories be added to the HRAs. A few commenters
noted these three topics are important indicators of social needs that
are linked to individual health outcomes. A commenter noted that these
three risk factors are issues that SNPs are well-positioned to address.
Another commenter noted they supported the proposal and were already
implementing an assessment tool that covered these three topics. Other
commenters expressed support for all three topics, but noted
transportation in particular. A commenter noted that problems with
transportation can seriously impact access to care, and that advocates
and beneficiaries report that these problems are widespread. Another
commenter noted the importance of transportation for rural populations
that may need to travel significant distances to providers. A commenter
stated that SNPs armed with the knowledge that, for example, many of
their members are experiencing access barriers due to a lack of
transportation may wish to expand the availability of transportation
benefits.
A commenter expressed support for all three proposed topics, but
noted particular support for the inclusion of one or more questions
about food security. The commenter believed that requiring screening
for food insecurity will allow plans to better understand the important
interplay between food insecurity and chronic illness in their enrollee
populations, and will better equip plans to connect enrollees to
critical responsive services such as medically tailored meals.
Response: We appreciate the support for our proposed HRA question
topics. As we outlined in the proposed rule, we focused on housing
stability, food security, and access to transportation because there is
a large evidence base suggesting they have a particularly significant
influence on the physical, psychosocial, and functional needs of the
enrollees. These comments reinforce our belief that these three topics
are the most important factors for which SNPs should be screening their
enrollees.
Comment: Some commenters expressed support for the three topic
[[Page 27729]]
areas included in the proposed rule but recommended that CMS include
questions on additional topics as well. Several commenters recommended
adding a question about family and unpaid caregiver support. A
commenter noted that understanding how much support a SNP member has at
home--or the caregiving responsibilities they may have--has direct
connections to health outcomes of SNP enrollees and may provide
information on the prevalence of family caregivers and the need to
better support them to help ensure members can continue to live in the
community. Another commenter believed that addressing this topic and
expanding supports for caregivers could reduce future reliance on
Medicaid-funded LTSS and limit growth in LTSS expenditures. A few
commenters suggested adding questions about caregiver burden in
particular, noting that early recognition of caregiver burden can lead
to targeted supports, and a lack of recognition of caregiver burden can
prompt an emergency department visit or hospitalization. A commenter
also suggested CMS add an assessment question about symptom burden,
noting that the SNP assessment can be a powerful opportunity to
identify poorly managed pain and symptoms and avoid crises like
potentially preventable emergency department visits. The commenter
recommended that, at minimum, questions about symptom burden as well as
caregiver burden be required for SNP enrollees with certain serious
illnesses, but also believed there are benefits to including those two
topics in HRAs for all SNP enrollees.
Another commenter recommended multiple additional domains such as
such as functional status, frailty, spoken language, and health
literacy. Several other commenters encouraged CMS to include one or
more questions on health literacy. A commenter noted that a question
related to health literacy gets at the individual's ability to
understand and ask questions about health information they receive,
which the commenter suggested could have a significant impact on health
outcomes.
Some commenters recommended CMS include questions on both health
literacy and social isolation. A commenter noted that these two health-
related social needs are prevalent among SNP populations and have
direct impacts on health outcomes and behaviors, and expressed support
for validated, concise screening tools on these topics, such as the
Single Item Literacy Screener and AHC Model HRSN Screening Tool.
Another commenter pointed to research showing that low health literacy
is associated with nonadherence to treatment plans and puts patients at
higher risk for hospitalization and mortality, and noted disparities in
health literacy among different racial and ethnic groups. The commenter
also believed the COVID-19 pandemic has highlighted weaknesses in the
social support systems of older adults and at-risk populations, and
noted that social isolation is associated with increased risk for
premature mortality and significantly influences physical, mental, and
cognitive health outcomes. A few commenters suggested CMS include a
question on social isolation. A commenter recommended CMS include a
question on social isolation rather than one on access to
transportation. The commenter believed transportation has not been as
high on the list of observed needs for SNP enrollees--they noted this
was perhaps because many SNPs provide transportation as a supplemental
benefit.
A few commenters recommended CMS include questions related to
disability and functional limitations. These commenters believed that
information related to the SDOH is not enough and that, without
information on disability status, the assessment is incomplete and will
perpetuate the disparities it seeks to uncover. Another commenter
recommended including questions about interpersonal violence and its
subdomains intimate partner violence and elder abuse, as well as
utilities insecurity, and noted that the AHC HRSN screening tool
includes these topics.
A commenter expressed support for CMS's three proposed topic areas,
but noted some populations may not have those specific needs depending
on individual circumstances or geographic location. The commenter
believed an exclusive focus on these three social needs could miss
other critical social needs that are more relevant, and noted that the
relevance of different social needs questions will vary depending on
individual circumstances, geographic location, populations served, and
resource availability, among other factors. Another commenter noted
that once the proposed HRA questions have been implemented
successfully, CMS could consider adding new questions or expanding to
other social needs topics, such as social isolation and access to
telehealth.
Response: We appreciate the commenters' suggestions and acknowledge
that the domains these commenters suggested are all important
indicators of unmet enrollee needs. However, we maintain that the three
topics we proposed have the strongest currently available evidence base
\32\ suggesting they have a particularly significant influence on
health outcomes, and we still value parsimony in establishing new HRA
requirements. Furthermore, the three topics on which SNP HRAs will be
required to solicit information align with other efforts in this arena,
such as the National Committee for Quality Assurance (NCQA) proposed
Social Need Screening and Intervention HEDIS measure, which measures
the percent of enrollees who were screened for unmet food, housing, and
transportation needs, and received a corresponding intervention if they
screened positive.\33\ As we discuss in more detail later in this
section, the requirement we are finalizing at Sec. 422.101(f)(1)(i)
allows SNPs flexibility to include questions from a list of screening
instruments specified by CMS in sub-regulatory guidance on housing
stability, food security, and access to transportation. The amendment
we are finalizing to Sec. 422.101(f)(1)(i) does not preclude SNPs from
including additional questions in their HRAs as appropriate for their
enrollee populations. The broad language at section 1859(f)(5)(A) of
the Act and at Sec. 422.101(f) provide SNPs a great deal of
flexibility in developing their HRA tools to gather information about
the unique physical, psychosocial, and functional needs of their
enrollee populations in order to better meet those needs and coordinate
care for the specific special needs population enrolled in the plan.
Additionally, we may consider adding more, specific question topics in
future rulemaking. We note that current regulations do not contain any
specific requirements similar to what we are adopting in this rule, and
we believe it is appropriate to first assess experiences implementing
the change we are finalizing in this rule before proposing to require
questions on other topics.
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\32\ See, for example, Kushel M.B., Gupta R., Gee L., Haas J.S..
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.
\33\ <a href="https://www.ncqa.org/blog/hedis-public-comment-period-is-now-open/">https://www.ncqa.org/blog/hedis-public-comment-period-is-now-open/</a>.
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Comment: Some commenters recommended that CMS require collection of
patient demographic information as part of the HRA, including a variety
of factors, such as race, ethnicity, sex, gender, gender identity,
sexual orientation, language, disability, and others. A few of these
commenters noted collecting this information is important to
understanding how demographic
[[Page 27730]]
characteristics interact with each other intersectionally as well as
with health outcomes, and is important to identifying disparities
within a plan and in the SNP population more broadly. A commenter noted
that collecting demographic information should be accompanied by
quality improvement initiatives to reduce health disparities, such as
improving a plan's ability to provide primary care in a culturally and
linguistically appropriate manner. A commenter noted that demographic
information can help facilitate a culturally sensitive care planning
process for SNP enrollees. Another commenter expressed support for the
proposal, but urged CMS to add safeguards to ensure the questions are
framed and presented, and the answers are received, in respectful and
culturally competent ways. The commenter encouraged all such questions
to be posed only by people who have had training to combat implicit
bias.
A commenter recommended ensuring that SDOH data standards are
inclusive so there is not exclusion and further marginalization of
populations due to limited definitions such as gender being defined as
binary male or female, excluding individuals of other genders including
nonbinary, agender, and transgender. Another commenter believed there
is a need to move beyond individual SDOH factors to incorporate factors
at the neighborhood, community, and zip code level, such as housing
discrimination, to identify systematic and institutionalized forms of
discrimination that may affect health.
A few commenters recommended that CMS include an option for an
enrollee to choose not to respond to the proposed HRA questions to
protect enrollee choice and privacy.
Response: We appreciate the commenters' input and agree that
collecting enrollee demographic and other information can provide the
plan with a more complete picture of the enrollee. We believe that many
SNPs are already collecting demographic and other information as
described in the comments, and therefore we have chosen to focus on the
three topics we proposed for parsimony. The amendment we are finalizing
at Sec. 422.101 requires SNPs to include one or more questions on
housing stability, food security, and access to transportation using
questions from a list of screening instruments specified by CMS in sub-
regulatory guidance. We believe this approach allows SNPs enough
flexibility to choose questions that are the most appropriate for their
enrollee populations while still maintaining some of the benefits of
standardization. We encourage SNPs to ensure HRAs are conducted in a
culturally sensitive manner. We also clarify that enrollees always have
the option to refuse to answer an HRA question if they choose.
Comment: Some commenters suggested CMS require alternative or
additional questions from those discussed in the proposed rule at 87 FR
1859 that cover the same three proposed topics or closely related
topics. A commenter suggested CMS consider the National Comprehensive
Cancer Network's Distress Thermometer assessment, a well-known
screening tool among oncology providers, that includes housing, food
security, and transportation among other topics. Another commenter
noted examples of questions covering these three topics that are
required for D-SNPs in the commenter's State. A commenter believed the
examples in the proposed rule provided a good starting point for the
subsequent sub-regulatory guidance, but also offered additional
questions for consideration on topics related to those in the proposed
rule, including questions about fall risk in the home, barriers to
shopping for healthy food, and whether lack of access to transportation
is persistent or infrequent, among other questions. Another commenter
recommended CMS require SNPs to include in their HRAs questions across
three specific housing specific domains, not just the proposed topic of
housing stability: Homelessness, housing instability, and inadequate
housing, noting that the AHC HRSN screening tool identifies all three
housing topics. A commenter cautioned CMS against utilizing questions
from the PAC assessment instruments. The commenter noted the patient
assessment instruments used in each of the PAC settings are based on a
``medical'' model designed to determine medical care needs and
associated resource use, and believed the information collected in the
PAC assessments is insufficient to address ongoing social or medical
needs.
Response: We appreciate the commenter's suggestions. As discussed
in more detail later in this section, we are finalizing language at
Sec. 422.101(f)(1)(i) to require SNPs to include one or more questions
from a list of screening instruments specified by CMS sub-regulatory
guidance that complies with the Paperwork Reduction Act on housing
stability, food security, and access to transportation (rather than
requiring that all SNPs use the same specific standardized questions on
these topics as proposed). We recognize that a variety of HRA questions
on these topics could allow SNPs to collect meaningful information on
their enrollees' needs. The requirement we are finalizing in this rule
provides SNPs with some flexibility to select the specific questions on
these topics that are most appropriate for their enrollees from the
list of screening tools specified by CMS in sub-regulatory guidance. We
remind SNPs that they may also choose to include additional questions
that are related to the three required topics, but not exactly the
same, such as fall risk in the home, for example.
Comment: A number of commenters expressed concern that the addition
of the proposed questions to HRAs would make the assessments too long
and burdensome. Several commenters suggested that CMS limit the number
of questions SNPs must include in their assessments. A commenter
recommended CMS limit the number of required questions to one question
on each of the three proposed domains. A few commenters stated CMS
should start with just a few questions and/or interoperable codes
relating to housing, food, and transportation. Other commenters
believed adding the proposed questions could reduce HRA completion
rates.
Response: We appreciate the commenters' perspective on this issue.
We believe that the potential benefit of SNPs having a more complete
picture their enrollees' physical, psychosocial, and functional needs
as required at Sec. 422.101(f)(1)(i) outweighs the potential burden of
including these questions in an assessment. Furthermore, because the
requirement we are finalizing allows SNPs some flexibility to choose
questions on housing stability, food security, and access to
transportation from a list of screening tools specified by CMS in sub-
regulatory guidance, SNPs can potentially continue using existing
questions on these topics they already include in their HRAs if they
are from the CMS-specified list, reducing the potential for
administrative burden. We anticipate that the list of tools included in
the CMS sub-regulatory guidance will likely include screening tools
that are widely used in the industry and that SNPs may already be using
for their HRAs. We will seek input on the list of screening instruments
and comply with the Paperwork Reduction Act.
Comment: A commenter suggested that, instead of questions on the
three proposed domains, CMS use a one-to-two-question pre-screener that
asks enrollees their needs or challenges across a wider range of social
needs (such as social isolation, employment, safety, legal needs,
assistance with
[[Page 27731]]
utilities, issues with a person's living or home environment, material
security, and digital access, in addition to housing, food and
transportation). While the commenter recognized that social needs pre-
screeners have not been widely used or vetted, the commenter believed
pre-screeners could allow for a more holistic assessment of enrollee
needs, which can then be followed up by additional questions if needed
and be used to better inform care.
Response: We appreciate the commenter's suggestion; however, as the
commenter noted, this approach has not been widely used or vetted. We
prefer that SNPs use questions from validated or otherwise widely used
assessment instruments (including any required by States), because we
believe they will allow SNPs to collect high-quality, actionable
information on their enrollees--at the individual level as well as at
the population level--to more holistically understand the barriers to
care enrollees face. While we are not familiar with exactly what type
of questions would be included in such a pre-screener, we do not
believe that a question that asks enrollees about their needs across
such a wide range of domains is likely to receive useful responses.
Because we believe using validated or otherwise widely used assessment
instruments is important to understanding and addressing enrollee
needs, we are finalizing a requirement at Sec. 422.101(f)(1)(i) that
SNPs include one or more questions from a list of screening instruments
specified by CMS in sub-regulatory guidance on housing stability, food
security, and access to transportation.
Comment: A few commenters opposed requiring questions about social
risk factors as part of SNP HRAs. A commenter recommended CMS give
health plans the choice to include these questions on their HRAs to
preserve assessment completion rates. Another commenter suggested CMS
consider providing a list of standardized optional HRA questions, and
noted that States could choose to require D-SNPs to include one or more
optional questions in their HRAs, and individual plans could decide to
include them as well. The commenter noted that plans using the optional
questions could provide feedback to CMS on ease of use to help inform a
future CMS decision about requiring these additional questions.
Response: We disagree with the recommendation to make questions
about social risk factors optional for SNPs. We believe it is necessary
to require SNPs to include questions about housing stability, food
security, and access to transportation in order to have a more complete
understanding of enrollees' physical, psychosocial, and functional
needs. Though we are aware that many SNPs may already be asking their
enrollees various questions related to SDOH, we want to ensure that, at
minimum, SNPs are collecting information on these three key topics that
are among the most influential to an enrollee's health outcomes. We
remind commenters that SNPs currently have the option to include
questions about social risk factors on their HRAs; making the proposed
questions optional would not necessarily expand the screening of SNP
enrollees for social risk factors from the level of screening that SNPs
are doing currently.
Comment: A significant number of commenters expressed support for
requiring standardized questions on the proposed topics. A commenter
noted that standardized questions would streamline and facilitate ease
in reporting, leading to improved data collection and higher quality
data that more reliably measures impact and progress across
populations. Another commenter believed that a lack of standardized
data has impaired the ability of policymakers to fully understand the
links between social risk factors and health inequities. Other
commenters believed standardization would better ensure beneficiary
needs are systematically identified and enable SNPs to develop and
implement models of care to address those needs.
Several commenters noted standardized questions could improve SNPs'
ability to understand prevalence and trends in social risk factors
among enrollees. Several commenters also noted that standardized
questions would enhance both SNPs' and CMS's ability to collect,
analyze, and publicly report disparity- and equity-related data.
Another commenter noted that developing standards for collecting and
sharing SDOH-related data can result in actionable insights into
disparities while improving data sharing across sectors. A commenter
noted the importance of standardized data on food security in
particular, stating that the use of standardized screening questions
would provide data needed to better understand the impact of food
insecurity and chronic illness across SNPs as a whole. A few commenters
noted the importance of standardized assessment questions to data
exchange between SNPs.
A commenter noted that there is a key need for standardized data on
SDOH for interoperability purposes, the importance of which has been
further amplified during the COVID-19 pandemic. A few commenters
applauded CMS's intent to align the selected HRA questions with the
SDOH data elements established as part of the USCDI v2. A commenter
noted, however, there is still clarification needed to make certain the
USCDI v2 questions would integrate seamlessly with traditional health
information and result in successful interoperability.
A few commenters stated that implementing standardized questions
such as those from the AHC Model screening tool would ensure that plans
are using screening questions that have been tested for validity and
reliability and to maximize opportunities to compare data across
settings. Another commenter stated that SDOH-related information should
be standardized across plans and Medicare programs to ensure the
screening tools health plans are utilizing to capture this information
are uniformly adopted across SNP, MA, Health Exchange and Medicaid
plans.
A health plan commenter noted that they are already utilizing
questions from the AHC HRSN screening tool to assess their enrollees
and track their needs. The commenter noted that using this standardized
tool has informed how they invested in internal capabilities and formed
community partnerships to meet enrollee needs and improve their health.
A few commenters stated that standardized questions would support
plans' ability to address enrollee needs directly or to make referrals
to social service organizations and programs. Another commenter
believed that SNPs are in a unique position to meet enrollee needs
because they have the flexibility to create unique benefit packages
which can get to the root of many of the most important SDOH.
A commenter noted that they did not have a preference to which
questions are specified (that is, from which standardized screening
tool), but they strongly encouraged CMS to include standardized
questions in sub-regulatory guidance and recommended that CMS
coordinate with other HHS agencies to require the same set of
standardized questions.
A commenter requested that CMS consider standardizing all questions
on SNP HRAs to increase care coordination. Another commenter suggested
CMS should provide clear definitions of housing, food, and
transportation insecurity and word questions in a way to limit any
ambiguity of the responses to increase the probability that MA plans
get quantifiable, actionable data. They encourage CMS to reference
existing tools and assessment questions when developing the
standardized questions so that there is consistency with
[[Page 27732]]
screening tools already in use by providers and social services
organizations.
Response: We appreciate the commenters' support for our proposal to
require standardized questions, and the commenters' perspective that
standardizing the collection of information on SNP enrollees' social
risk factors would improve SNPs' ability to understand their enrollees'
needs, track those needs over time, and improve interoperability and
data exchange between plans as well as between plans and CMS, should
CMS require the SNPs to report this data. We are finalizing an
amendment at Sec. 422.101(f)(1)(i) to require SNPs to include one or
more questions from a list of screening instruments specified by CMS in
sub-regulatory guidance on housing stability, food security, and access
to transportation in their HRAs. However, we are not finalizing the
part of our proposal that required SNPs to use specific standardized
questions identified by CMS. We believe this middle-ground approach
will retain some of the benefits of standardization while mitigating
the potential downsides of using standardized questions, such as
possibly (and unintentionally) limiting the opportunity to adopt
questions that maximize cultural competence, potential increases in
administrative burden and cost, and the potential for redundancy in
States that have similar (but not fully aligned) requirements in their
Medicaid programs. Requiring questions on the three topics from a CMS-
specified list of screening tools, rather than specific standardized
questions, will allow SNPs to choose questions from the specified tools
on these topics that are most relevant to their enrollee populations.
We considered concerns about the administrative burden associated
with modifying an HRA, as discussed in response to comments later in
this section. We recognize that it could be burdensome for a SNP that
is already asking questions on these topics in its current HRA to
replace those questions with new ones from a CMS-specified list of
screening tools. However, we believe that some degree of
standardization helps ensure that SNPs are using validated questions
and gathering high-quality, actionable responses from enrollees.
Therefore, we are finalizing a requirement at Sec. 422.101(f)(1)(i)
for SNPs to include one or more questions from a list of screening
instruments specified by CMS in sub-regulatory guidance on housing
stability, food security, and access to transportation in their HRAs.
In response to commenters who expressed support for standardization
because of its potential for improved data collection and exchange, we
recognize there is a need for greater interoperability in this area.
Though we are not limiting SNPs to specific questions identified by
CMS, we are requiring SNPs to use questions from a list of screening
instruments specified by CMS in sub-regulatory guidance. While this
provides a measure of flexibility for SNPs, by limiting the scope of
available questions on these three domains to specified instruments, we
expect there will be some degree of standardization. We anticipate
including validated, health IT-enabled assessment tools on the CMS-
specified list in order to maximize opportunities for standardized data
collection and analysis. We also anticipate our sub-regulatory guidance
will include screening instruments that have been developed with clear
definitions of housing stability, food security, and access to
transportation and that word questions in a way to limit any ambiguity
of the responses and increase the probability that SNPs gather
quantifiable, actionable data. As we develop the CMS-specified list in
sub-regulatory guidance, we will consider existing requirements in
other HHS programs, and will coordinate with agency partners to
identify opportunities for burden reduction. In addition, the sub-
regulatory guidance will include the option to use State-required
Medicaid screening instruments that include questions on these domains.
In response to the commenter who requested that CMS consider
standardizing all HRA questions, we note that we do not currently
require any specific questions on SNP HRAs, and implementing such a
large-scale requirement is outside the scope of this rulemaking.
We clarify that this requirement only applies to SNP HRAs, though
other MA plans are free to include questions on these topics on the
one-time HRAs they are required to make a best effort to complete
within 90 days of enrollment under Sec. 422.112(b)(4)(i).
Comment: Numerous commenters opposed the requirement to include
standardized questions specified by CMS. A number of commenters
recommended that CMS instead set more flexible guidelines that allow
plans to select their own assessment questions, such as requiring
questions on certain topics rather than dictating the questions
themselves. Some commenters asked CMS to consider allowing SNPs that
are already collecting information on the proposed topic areas in their
HRAs to continue using their existing questions. Another commenter
believed flexibility to select and customize assessment instruments and
questions is the best approach to encourage screening for a broad array
of needs and identifying an enrollee's most salient needs.
A commenter believed that requiring standardized questions would be
expensive and cumbersome to change HRA questionnaires to match the CMS-
specified question wording for plans that already actively work with
SDOH assessment software vendors. Another commenter noted there is
already a robust data collection environment in this area, and that
payers and providers may have existing interoperable systems with their
own definitions and language that encode social needs questions in HRAs
and electronic health records (EHRs). The commenter believed the CMS
proposal could require multiple organizations to modify data collection
and IT systems and have significant spillover impacts into provider
EHRs. Another commenter believed that prescriptive HRA elements would
disrupt SNP operations and have an adverse impact on overall HRA
completion rates. The commenter did not believe that the HRA questions
themselves must be standardized in order for SNPs to have a more
complete picture of their enrollees' risk factors.
A few commenters noted concerns about continuity in HRA data. A
commenter expressed concern that, in the case of States and SNPs that
have already been collecting this information, existing and baseline
data could be lost or marginalized. Another commenter expressed concern
that changes to their existing HRA would prevent them from doing
effective historical data analysis.
Several commenters believed that requiring standardized questions
would be burdensome for SNP enrollees, citing that enrollees may
already be answering similar but slightly different questions in other
assessments, such as in Medicaid programs. A commenter noted that most
D-SNPs actively work with State partners to simplify data collection
tools so that beneficiaries do not have to answer multiple questions
with similar responses, and suggested that this proposal could get in
the way of that coordination and lead to assessment burden among
enrollees. A commenter expressed concern that beneficiaries would be
required to answer multiple related questions solely as a result of
this requirement.
Other commenters believed SNPs should be able to continue using
their own assessment questions on topics
[[Page 27733]]
related to social risk factors because they tailored them to their
specific enrollee populations and developed them over time to obtain
more detailed information from enrollees. A commenter believed that
standardized questions can lead to enrollees not feeling comfortable
sharing information. Another commenter believed that CMS's proposal
would prevent organizations from using validated questions they have
determined work best to elicit information that is most effective in
developing individualized plans of care for their enrollees. Another
commenter believed plans are in the best position to review and revise
their current HRAs to ensure collection of information and avoid
overlap or unnecessary burden on enrollees.
A few commenters expressed concern about standardized assessment
questions needing to be translated. A commenter stated that
expectations of enrollees may differ in certain SNP service areas due
to a range of cultural, linguistic, social, geographic, and economic
factors, and believed that CMS should consider giving plans flexibility
so that information on housing stability, food security, and access to
transportation can be sought in a manner that is culturally and
linguistically appropriate.
Response: We appreciate the commenters' concerns about requiring
standardized questions in SNP HRAs. We recognize the challenge that
CMS-specified standardized questions can pose to SNPs in terms of plan
administrative burden and to enrollees in terms of potentially being
asked multiple similar questions, and we acknowledge the commenters'
perspective that SNPs are best-suited to develop questions that are
most appropriate to their specific enrollee populations. We are also
particularly sensitive to concerns about cultural and linguistic
competence in HRAs. We agree with the commenter who stated that
enrollee expectations may differ in different SNP service areas, and
understand that an assessment question that is appropriate for one
group of enrollees may be irrelevant or insensitive to another group.
As discussed earlier in this section, we believe that the downsides of
requiring specific standardized questions, including the potential
administrative burden and duplication of existing efforts, outweigh the
potential benefits of requiring specific standardized questions.
However, we believe some degree of standardization helps ensure that
SNPs are collecting high-quality, actionable responses from enrollees.
We also believe using questions from a CMS-specified list of screening
instruments increases the likelihood of SNP HRA data being shared in a
meaningful way because the answers can be comparable across populations
that are using the same questions. Therefore, we are finalizing
language at Sec. 422.101(f)(1)(i) that requires SNPs to include one or
more questions from a list of screening tools specified by CMS in sub-
regulatory guidance on housing stability, food security, and access to
transportation in their HRAs. The sub-regulatory guidance will include
the option to use State-required Medicaid screening instruments that
include questions on these domains. We believe the requirement we are
finalizing allows SNPs enough flexibility to choose questions that are
appropriate for their enrollee population, given that they will be able
to choose from a CMS-specified list of assessment tools. We also
believe the requirement we are finalizing addresses commenters'
concerns about the need to make burdensome changes to information
technology (IT) and EHR systems to utilize CMS-specified standardized
questions. We aim to include validated, widely available screening
tools in our sub-regulatory guidance, similar to the tools included in
the proposed NCQA Social Need Screening and Intervention HEDIS measure.
We believe many plans may already be using questions from one or more
of these types of screening tools. As a result, relative to our
proposal, we believe there will be less need for systems, IT, and EHR
changes.
[…truncated; see source link]Indexed from Federal Register on May 9, 2022.
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