Insights

In June 2026, federal regulators and lawmakers continued their efforts to improve drug affordability through targeted reforms. These recent developments will primarily impact pharmaceutical manufacturers, managed care organizations, and pharmacy benefit managers (PBM) serving Medicare Part D program members. PBMs, Medicare Advantage organizations, and Part D sponsors should monitor these changes in the interest of maintaining compliance and providing input on regulatory proposals that may influence their business operations or compensation structures in the future.

On Wednesday, June 3, 2026, the Department of Health and Human Services (HHS) published an interim final rule with comment (IFC) instructing all state Medicaid agencies to incorporate “community engagement” as an eligibility condition for program participation by no later than January 1, 2027. The rule (Medicaid Program; Community Engagement Requirement for Certain Individuals) does not impose affirmative operational obligations for Medicaid managed care plans, as it focuses primarily on equipping the states to administer the community engagement requirement. However, it does establish a few specific guardrails to govern the role managed care organizations, prepaid inpatient health plans, and prepaid ambulatory health plans may — and may not — play in that administration.

On April 10, 2026, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (2026 CMS Interoperability Standards and Prior Authorization for Drugs, or CMS-0062-P) outlining the agency’s plans to impose new interoperability requirements on payors participating in certain Medicare and Medicaid programs. As described by the agency in a recent press release, the proposed rule “builds on” prior rulemaking by clarifying and enhancing interoperability requirements for payors’ prior authorization processes, specifically those associated with coverage requests for pharmaceutical therapies.