The 957-page rule includes proposals to improve protections for people with Medicare, expand access to behavioral health care, promote equity in coverage, and make prescription drugs more affordable for low-income individuals.
The Centers for Medicare & Medicaid Services (CMS) on Wednesday released the 2024 Medicare Advantage (MA) proposed rule, which is scheduled to be published in the Federal Register on December 27. The proposals include changes to the MA program, including coverage guidelines, improvements to prior authorization, and plan marketing requirements. Comments on the proposed rule are due by February 13, 2023.
“CMS released a proposed rule today that takes important steps to hold Medicare Advantage plans accountable for providing high quality coverage and care to enrollees,” said CMS Administrator Chiquita Brooks-LaSure in an announcement. “The rule also strengthens Medicare prescription drug coverage and implements an important provision of the Inflation Reduction Act to help more people with Medicare who have modest incomes afford their prescriptions.”
Here’s a summary of key changes included in the rule:
Adds health equity to Star ratings, drops weight of patient experience measures
CMS has committed to advancing health equity and to help achieve that goal proposes to establish a health equity index in the Star ratings program that would reward MA and Medicare Part D plans for providing excellent care to underserved populations. If finalized, the health equity index reward would begin with the 2027 Star ratings using measure data from the 2024 and 2025 measurement years and aims to encourage MA and Part D plans to improve care for enrollees with certain social risk factors, such as dual eligibility, low-income subsidies, and disability.
The agency also wants to reduce the weight of patient experience/complaints and access measures by half (from four to two) to further align with other CMS quality programs and the current CMS Quality Strategy that promotes quality outcomes.
It also intends to:
- Remove guardrails (bi-directional caps that restrict upward and downward movement of a measure’s cut points compared to the prior year) when determining measure-specific-thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures
- Modify the Improvement Measure hold harmless policy
- Include an additional rule for the removal of Star ratings measures
- Remove the 60 percent rule that is part of the adjustment for extreme and uncontrollable circumstances
- Remove the Part C Diabetes Care– Kidney Disease Monitoring and the stand-alone Medication Reconciliation Post- discharge measures
- Add the Part C Kidney Health Evaluation for Patients with Diabetes and the updated Colorectal Cancer Screening and Care for Older Adult –Functional Status Assessment measures
- Add the Part D Concurrent Use of Opioids and Benzodiazepines, Polypharmacy Use of Multiple Anticholinergic Medications in Older Adults, and Polypharmacy Use of Multiple Central Nervous System Active Medications in Older Adults measures
- Update the Part D Medication Adherence for Diabetes Medications, Medication Adherence for Hypertension (RAS Antagonists), and Medication Adherence for Cholesterol (Statins) measures
- Make technical clarifications related to the disaster adjustment, Quality Bonus Payment appeals processes, treatment of ratings for contracts after consolidation, weighting of measures with a substantive specification change, and addressing the codification error related to use of Tukey outlier deletion
The proposed rule, HHS said in the announcement, would balance the emphasis between patient experience, complaints, and access Star ratings measures and health outcomes Star ratings measures to focus more effectively both on patient-centric care and on improving clinical outcomes.
Changes to coverage criteria, including more adjustments to prior authorization
The rule proposes clarifications and revisions to regulations governing when and how MA plans develop and use coverage criteria and utilization management policies to ensure enrollees receive the same access to medically necessary care they would receive in Traditional Medicare.
In situations when no applicable Medicare statute, regulation, National Coverage Determinations (NCD), or Local Coverage Determinations establishes when an item or service must be covered, MA organizations must include current evidence in widely used treatment guidelines or clinical literature made publicly available to CMS, enrollees, and providers when creating internal clinical coverage criteria. CMS said that these proposed changes, including requiring that the physician or other health care professional used by the MA plan have expertise in the field of medicine that is appropriate for the service be involved before the MA plan can deny coverage, would help ensure enrollees have consistent access to medically necessary care.
CMS also proposes additional policies to streamline prior authorization requirements and reduce disruption for enrollees. If finalized, the rule would require:
- Granted prior authorization approval remain valid for an enrollee’s full course of treatment
- Policies for coordinated care plans be used only to confirm the presence of diagnoses or other clinical criteria and/or ensure that an item or service is medically necessary
- Plans to provide a minimum 90-day transition period when an enrollee currently undergoing treatment switches to a new MA plan
- MA plans establish a Utilization Management Committee to annually review utilization management policies
- Professionals with relevant expertise to review coverage determinations
Aims to curtail misleading MA marketing
CMS also wants to protect people exploring MA and Part D coverage from confusing and potentially misleading marketing while also ensuring access to accurate and necessary information to make coverage choices.
The spike in certain television advertisements generically promoting Medicare Advantage enrollment has been a topic of concern for the past year. To address this problem, CMS wants to prevent predatory marketing and prohibit ads that do not mention a specific plan name as well as ads that use words and imagery that may be confusing or use language or logos, such as the Medicare name or logo in a way that is misleading, confusing, or misrepresents the plan.
CMS also proposes to codify guidance protecting people with Medicare or exploring Medicare coverage from misleading marketing and ensure they are not pressured into enrolling into plans that may not best meet their needs or attending events. Further, CMS is proposing to strengthen the role of plans in monitoring agent and broker activity.
The proposals include bans on:
- Sales presentations that immediately follow an educational event
- Agent distribution and collection of scope of appointment and business reply to cards at educational events
- Agents from conducting a sale and/or enrollment meeting with a beneficiary within 48 hours after a beneficiary’s consent
- Use of Medicare language or logos in advertisements that mislead Medicare enrollees into believing these advertisements are from the governments
To ensure that Medicare enrollees receive accurate information about Medicare coverage, CMS wants to require agents to:
- Disclose to beneficiaries all the plans the agent sells
- Inform beneficiaries that they can obtain complete Medicare options/information from 1-800-MEDICARE, SHIPs, or Medicare.gov
- Ask a standard list of questions that address a beneficiary’s health care needs, current providers, and prescriptions before enrolling a beneficiary into a plan
- Provide the pre-enrollment checklist to prospective enrollees, which would include the effect on current coverage if they change plans
- Thoroughly review the pre-enrollment checklist with prospective enrollees during telephonic enrollments before completing enrollments
Improve access to behavioral health
To address the national mental health crisis, CMS wants to improve behavioral health network adequacy by adding clinical psychologists, licensed clinical social workers, and prescribers of medication for opioid use disorder to the list of evaluated specialties. In addition, the agency pitches new minimum wait time standards for behavioral health and primary care services and more specific notice requirements from plans to patients when these providers are dropped from their networks. CMS also proposes to require most types of MA plans to include behavioral health service in care coordination programs, ensuring that behavioral health care is a core part of person-centered care planning.
Culturally competent care clarifications
To further address health equity, CMS proposes further clarification of a current requirement for MA plans to provide culturally competent care by expanding the list of populations that MA organizations must provide services to in a culturally competent manner. This includes people:
- with limited English proficiency or reading skills
- of ethnic, cultural, racial, or religious minority groups
- with disabilities
- who identify as lesbian, gay, bisexual, or other diverse sexual orientations
- who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex
- who live in rural areas and other areas with high levels of deprivation
- otherwise adversely affected by persistent poverty or inequality
CMS said that studies demonstrate that low digital health literacy, especially among populations experiencing health disparities, continues to impede telehealth access and worsen care gaps particularly among older adults. To address this, CMS wants to require MA organizations to develop and maintain procedures to offer digital health education to enrollees to improve access to medically necessary covered telehealth benefits. In addition, it proposes building on current best practices by requiring MA organizations to include providers’ cultural and linguistic capabilities in provider directories. If finalized, this change would improve the quality and usability of provider directories, particularly for non-English speakers, limited English proficient individuals, and enrollees who use American Sign Language.
Finally, CMS proposes that MA organizations must address health disparities as part of existing requirements to develop and maintain quality improvement programs.
Improve drug affordability and access in Part D
To provide Part D sponsors with additional tools to manage drug costs, CMS proposes greater formulary flexibility for certain biological products and authorized generics. While certain formulary changes are subject to CMS approval and 30 days’ advance notice to affected beneficiaries, current regulations permit Part D sponsors to immediately remove from the formulary a brand name drug and substitute its newly released generic equivalent. Part D sponsors meeting these requirements can provide notice of specific changes, including direct notice to affected beneficiaries, after they take place and do not need to provide a transition supply of the substituted drug. Consistent with these requirements, CMS proposes to permit Part D sponsors to immediately substitute:
- a new interchangeable biological product for its corresponding reference product
- a new unbranded biological product for its corresponding brand name biological product
- a new authorized generic for its corresponding brand name equivalent
Updates to Medicare Part D MTM program
CMS also wants to make updates to the Medicare Part D medication therapy management (MTM) program to improve access. Among the proposals:
- Require plans to include all 10 core chronic diseases identified by CMS—including HIV/AIDS—in their MTM targeting criteria
- Lower the maximum number of covered Part D drugs a sponsor may require from eight to five drugs and require sponsors to include all Part D maintenance drugs in their targeting criteria
- Revising the methodology for calculating the cost threshold ($4,935 in 2023) to be commensurate with the average annual cost of five generic drugs ($1,004 in 2020)