These changes may enhance access to prescription drugs and care for older, low-income, and medically vulnerable individuals, reducing financial burden and improving continuity of care. By codifying protections and cost-sharing reforms, the rule helps ensure marginalized populations under Medicare maintain stable coverage. However, effectiveness will depend on plan-level implementation and disparities may persist if providers or insurers limit access to needed medications or services in underserved areas. Additionally, CMS states it does not intend to finalize proposals related to coverage of anti-obesity medications, requirements of health equity analysis of utilization management, and guardrails on the use of Artificial Intelligence to ensure equitable access to services. This rule also notably does not include beneficiary protection (education, directories, marketing oversight), administration of supplemental benefits through debit cards, cost-sharing for behavioral health benefits, or transparency of in-contractors in directories.
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A legally binding directive issued by a federal agency to implement, interpret, or enforce laws passed by Congress. Rules go through a formal rulemaking process, including public notice and comment, before taking effect.
Who It Impacts: Businesses, organizations, and individuals subject to federal agency oversight. For example, a new environmental regulation could impact manufacturing companies, or a healthcare rule could affect providers and insurers.
Who Is Not Impacted: People or entities not subject to the agency’s jurisdiction. For example, a rule by the Environmental Protection Agency (EPA) regulating industrial emissions would not directly impact a restaurant owner unless they operate in an affected industry.
Summary
The CY 2026 final rule updates Medicare Advantage, Part D drug plans, insulin cost-sharing, Medicare cost plans and PACE, revising payment policies, codifying drug-price and prescription-coverage adjustments under the Inflation Reduction Act, and adding transparency and technical changes to improve plan operations and beneficiary protections.
Impact Analysis
Legal Challenges
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Take Institutional Action
- Health care providers can review how CMS payment and coverage changes affect reimbursement rates and drug formularies; ensure patients are supported through transitions and benefit changes, especially older or low-income beneficiaries. Consider updating networks and contracts to comply with new requirements under the Part D redesign and drug-price negotiation modules.
- Monitor implementation to ensure equitable drug access and that cost savings or coverage improvements reach underserved seniors, people with disabilities, and low-income communities.
- Monitor for future rules issued which may address proposals that were not included in this rule.
Associated or Derivative Policies
The finalization implements changes required under the Inflation Reduction Act (IRA), including adjustments to the Part D benefit structure and drug-price negotiation mechanisms.
Policy Prior to 2025
Before this rule, Medicare Advantage and Part D operated under earlier payment, coverage, and benefit policies; certain protections and reforms (e.g., related to Part D restructuring under IRA) were not yet codified, and provider-directory transparency was more limited.
