On December 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would revise regulations governing Medicare Advantage (MA or Part C), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans, and Programs of All-Inclusive Care for the Elderly (PACE). The proposed rule aims to improve beneficiary protections, increase access to care, and promote equity in coverage and care.

Prior Authorization

CMS has proposed changes to prior authorization (PA) requirements in the MA program in response to concerns from the Association for Clinical Oncology (ASCO), the Office of the Inspector General, and other stakeholders that current PA policies limit beneficiary access to care. CMS has proposed the following changes:

• If Medicare statute is not explicit and an item or service doesn’t have a national or local coverage determination, MA plans must consider widely used treatment guidelines when creating internal clinical coverage criteria
• Coverage determinations must be reviewed by professionals with relevant medical expertise before a plan may deny coverage
• When an enrollee is granted prior authorization approval it will remain valid for the full course of treatment
• Plans must provide a minimum 90-day transition period when an enrollee currently undergoing treatment switches to a new MA plan
• MA plans must establish a Utilization Management Committee to review policies annually and ensure consistency with Traditional Medicare’s national and local coverage decisions and guidelines

Drug Pricing and Access in Part D

CMS proposes to permit Part D sponsors to make immediate formulary changes by substituting:

• 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

Part D sponsors meeting certain requirements could provide notice of these specific changes, including direct notice to affected beneficiaries, after they take place and would not need to provide a transition supply of the substituted drug.

The Inflation Reduction Act states that individuals with incomes up to 150% of the Federal Poverty Level (FPL) and who meet statutory resource requirements will qualify for full low-income subsidies in Part D beginning Jan. 1, 2024. CMS proposes to expand eligibility for full low-income subsidies to also include individuals who currently qualify for partial low-income subsidies.

Marketing Requirements

CMS has proposed several changes aimed at eliminating confusing and potentially misleading marketing practices. CMS has proposed to:

• Prohibit ads that do not mention a specific plan name and that use words and imagery, such as the Medicare name or logo, that may confuse beneficiaries in a way that is misleading, confusing, or misrepresents the plan
• Codify past guidance against high-pressure, predatory, and misleading marketing that pressures beneficiaries into enrolling in certain plans or attending enrollment events, including:
  • Banning sales presentations immediately following an educational event
  • Prohibiting agents from conducting a sale and/or enrollment meeting with a beneficiary within 48 hours of a beneficiary’s consent
  • Prohibiting use of Medicare language or logos in advertisements that mislead Medicare enrollees into believing these advertisements are from the government
• Adopt requirements that promote beneficiary receipt of accurate and thorough information about all Medicare coverage, including Traditional Medicare, and:
  • Requiring agents to disclose to beneficiaries all plans the agent sells
  • Requiring agents to inform beneficiaries that they can obtain complete Medicare options/information from 1-800-MEDICARE, State Health Insurance Assistance Programs (SHIPs), or Medicare.gov
  • Requiring agents to ask a standardized list of questions that address a beneficiary’s health care needs including current providers and prescriptions prior to enrolling a beneficiary into a plan
  • Requiring agents to provide the pre-enrollment checklist to prospective enrollees, which would include the effect on current coverage if he or she changes plans

Health Equity

CMS has proposed a variety of provisions related to addressing health equity in MA including:

• A health equity index reward, beginning with the 2027 Star Ratings, to encourage MA and Part D plans to improve care for enrollees with certain social risk factors (dual eligibility, low-income subsidies, and disability)
• Requiring MA plans to provide culturally competent care to an expanded list of populations adversely affected by persistent poverty or inequality
• Requiring MA organizations to develop and maintain procedures to offer digital health education to enrollees to improve access to medically necessary covered telehealth benefits
• Requiring MA organizations to include providers’ cultural and linguistic capabilities in provider directories

Read the proposed rule and CMS’ fact sheet.

Bookmark ASCO in Action for updates as well as news, advocacy and analysis on cancer policy.