Highlights and Potential Implications

• • Issued on December 14, 2022, the Medicare Advantage (MA) and Part D proposed rule includes revisions to regulations on MA (Part C), Part D, Medicare cost plans, and Programs of All-Inclusive Care for the Elderly (PACE). Within this release, CMS proposed a range of modifications and additions to plan requirements aimed at increasing access, improving beneficiary protections, and promoting health equity. If finalized, these changes would require plans to add and modify select operational protocols and coverage policies but would also provide flexibility in areas such as formulary changes under certain circumstances. For MA beneficiaries, these proposals would aim to create additional transparency and a more consumer-friendly experience.
  • These proposed changes signal a continued focus from CMS to provide sponsor plans with regulatory flexibility while ensuring beneficiaries have equal access to care and health information. Through these proposals, CMS continues to align quality incentives across Medicare programs, advance a whole-person approach to care through expanded behavioral health access, and manage drug costs through formulary flexibility.
  • CMS notes that this proposed rule is informed by an estimated 4,000 responses the agency received in response to the July 2022 MA request for information.

Additional Details

Access and Beneficiary Protections

 

Utilization Management Requirements: In response to numerous concerns regarding the use of prior authorizations and the effect on beneficiary access within MA, CMS is proposing several refinements around how MA plans develop and use coverage criteria and utilization management processes. These proposals are designed to give beneficiaries additional protections by ensuring they receive the same access to medically necessary care that they would otherwise receive through traditional Medicare. The proposals also require MA plans to substantiate their policies and implement maintenance processes to ensure consistency. Overall, CMS is proposing several new requirements, including:

• Requiring that MA plans reference, and make publicly available, evidence or clinical literature when creating internal coverage criteria for situations where no Medicare regulation or National/Local Coverage Determination (NCD/LCD) establishes coverage requirements.
• Implementing a policy that once an enrollee is granted prior authorization approval, it will remain valid for the full course of treatment.
• Clarifying that prior authorization policies for coordinated care plans can only be used to confirm patient diagnoses, or other clinical criteria, and ensure an item or service is medically necessary.
• Requiring that plans provide at least a 90-day transition period when an enrollee is undergoing treatment and switches to a new MA plan.
• Requiring that all MA plans establish a Utilization Management Committee to review policies annually and ensure consistency with national and local coverage guidelines.

Marketing Requirements: To address concerns about potentially misleading marketing while ensuring beneficiary access to accurate information, CMS is proposing to prohibit ads that: 1) do not mention a specific plan name, 2) use words and imagery such as the Medicare name or logo, and thus suggest the ads are coming from the government, and 3) may confuse beneficiaries in ways that may be misleading or provide a misrepresentation of the plan.

• CMS is also proposing additional changes such as a ban on sales presentations following an educational event, requiring plans to report to CMS any agents who fail to adhere to regulations, requiring agents to disclose to beneficiaries all the plans the agent sells, and requiring the agent to ask a standardized list of questions to assess the beneficiary’s healthcare needs and current providers prior to enrolling them in a plan.

Behavioral Health Access: To ensure beneficiary access to behavioral health services, CMS is proposing to strengthen network adequacy requirements as well as the responsibility of MA plans to provide these services. CMS is proposing several changes, including:

• Adding several provider types (clinical psychologists, licensed clinical social workers, and prescribers of medication for opioid use disorder) to the list of specialties for which minimum standards will be established and thus be factored into CMS’s evaluation of an MA plan’s network. If finalized, this change would also make these provider types eligible for the existing 10 percentage point telehealth credit.
• Modifying general access to service standards to explicitly include the need for behavioral health services.
• Codifying standard appointment wait times for both primary care and behavioral health.
• Including stabilizing emergency behavioral health services within the category of emergency services that must not be subject to prior authorization.
• Requiring MA plans to notify beneficiaries if a behavioral health or primary care provider is dropped from the network midyear.
• Requiring that MA plans establish care coordination programs that include community, social, and behavioral health services.

Quality Programs

Star Ratings Program: To better align the MA Star Ratings Program with other CMS programs and to continue driving quality improvement, CMS is proposing several changes to the Star Ratings Program, including:

• Removing several measures such as Part C Diabetes Care–Kidney Disease Monitoring and the stand-alone Part C Medication Reconciliation Post-Discharge measure.
• Adding measures such as Part C Kidney Health Evaluation for Patients with Diabetes measure and Part D Concurrent Use of Opioids and Benzodiazepines measures.
• Reducing the weight of patient experience and access measures by half to align with other programs and place additional focus on quality outcomes.
• Removing guardrails that put caps on the upward and downward movement of measure-specific-thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures.
• Removing the 60% rule for extreme and uncontrollable circumstances, also known as the adjustment for disasters.
• CMS is also proposing a health equity index (HEI) reward beginning with the 2027 Star Ratings. The 2027 rewards would be determined using data from 2024 and 2025 measurement years.

Other Updates

Enrollee Notification for Contract Termination: In the interest of putting enhanced requirements around termination notices and to codify best practices, CMS is proposing a 45-day telephonic notice specific to primary care and behavioral health contract terminations. The telephonic notice is in addition to the standard written communication requirement.

• CMS is proposing to remove “good faith effort” for enrollee notifications in the case of no-cause terminations. By removing this standard, CMS is clarifying that it will be a requirement to notify enrollees of no-cause provider terminations.

Advancing Health Equity: To improve equity for historically underserved and marginalized populations, CMS is proposing various refinements to MA plan requirements, including:

• Adding further clarification to an existing requirement on offering culturally competent care by expanding the list of included populations.
• Requiring MA plans to develop and offer digital health education to enrollees to improve access to covered telehealth benefits.
• Requiring MA plans to include cultural and linguistic capabilities of providers within their provider directories.

Managing Drug Costs: To enable Part D plan sponsors to manage drug costs more effectively, CMS is proposing additional formulary flexibility. These proposals from CMS build upon current regulations that permit Part D plans (in certain instances) to remove a brand-name drug from a formulary and immediately substitute with its newly released generic equivalent. CMS is now proposing to permit Part D plans to immediately substitute:

• A new interchangeable biological for its corresponding reference product.
• A new unbranded biological product for its corresponding brand-name biological.
• A new authorized generic for its corresponding brand-name equivalent.

Medication Therapy Management (MTM) Programs: Part D plan sponsors are required to provide MTM programs to ensure appropriate use of drugs and reduce the risk of adverse events. Within this rule, CMS is proposing a variety of changes to the MTM program targeting criteria to expand access and equity. This includes:

• Expanding the list of core chronic diseases in regulation to include HIV/AIDS, for a total of 10 core chronic diseases.
• Revising the annual cost threshold methodology to reflect the average annual cost of 5 generic drugs.
• Lowering the maximum number of covered Part D drugs a sponsor can require from 8 to 5 and requiring all Part D maintenance drugs to be included in the targeting criteria.

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_{Edited by: Matt Maslin}