Building upon prior issues and summarizing activity from July through September, the Fall 2024 PBM Update highlights federal legislative activity and oversight, state legislative activity and oversight, and other noteworthy events and trends affecting the PBM industry.

Read about the 2025 redesign of the Medicare Part D program pursuant to the Inflation Reduction Act of 2022 and how those changes impact Medicare Part D plan sponsors, beneficiaries, and manufacturers.

In ‘Third Edition: Q2 2024’ of the Mintz IRA Update, we cover updates to the Medicare Drug Price Negotiation Program being considered by CMS, developments in litigation challenging the program, the consequences and costs of redesigning the Part D program, opposition to the use of march-in rights to lower drug prices, and the growing use of state prescription drug affordability boards.

On July 9, 2024, the Federal Trade Commission (FTC) Office of Policy Planning released an Interim Staff Report titled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. The Interim Staff Report reflects the FTC’s work since it began its 6(b) study of PBMs in June 2022.  Mintz’s Health and Antitrust teams actively monitor federal and state regulatory and legislative developments in the PBM space, including those from the FTC. In this Special Edition of the PBM Policy and Legislative Update, the Mintz Health team partnered with our Antitrust colleagues to analyze the Interim Staff Report including Commissioner Melissa Holyoak’s dissenting statement.  We also highlight upcoming Congressional testimony by CEOs of the three largest PBMs, as well as media reports of a forthcoming FTC action related to PBM insulin rebate practices.

As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized a number of regulatory changes relating to how Medicare Advantage (MA) plans offer supplemental benefits and how they communicate such benefits to plan members. As previewed in the Proposed 2025 Rules, the Final Rule outlines CMS’s intentions to (i) more closely monitor the supplemental benefits that a Medicare Advantage organization (MAO) offers and categorizes as "Special Supplemental Benefits" for the Chronically Ill (SSBCI) and (ii) require MA plans to send annual notices to MA plan enrollees regarding their available supplemental benefits.