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.

Mintz is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from October through December 2023 that affects the PBM industry and will specifically highlight (i) federal legislative and enforcement updates, (ii) state legislative updates and litigation, (iii) other industry news, and (iv) Inflation Reduction Act (IRA) updates.

On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program…et al. These sweeping final rules finalized many changes that were introduced in the Proposed 2025 Rules and other changes that were proposed in the Proposed 2024 Rules. The rules will implement changes related to many areas, including, for example, Star Ratings, marketing and communications standards and requirements, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), Part D formularies, utilization management, and the Medicare Advantage and Part D application process.

In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, host Bridgette Keller is joined by women leaders in health care to discuss the emerging role of artificial intelligence (AI) in health care. This is the second episode of Mintz’s Women Leaders in Health Care – a series that highlights women leaders in the health care industry.  In this episode, Jane Moran, Chief Information and Digital Officer at Mass General Brigham; Rebecca Mishuris, Chief Medical Information Officer and Vice President at Mass General Brigham; and Carina Edwards, Chief Executive Officer at Kipu Health discuss opportunities for enhanced patient-provider interactions and improvements in health care delivery through the use of AI.

Get to know Jane, Rebecca, and Carina as they answer questions on their career, their advice for women in the health care industry, and the meaning of success and mindfulness. 

In this edition of the Mintz IRA Update, we cover the status of the negotiations underway between CMS and manufacturers pursuant to the Medicare Drug Price Negotiation Program and current legal challenges to the program, other drug pricing–related IRA initiatives, the IRA’s small biotech exemption, implications associated with removing the average manufacturer price cap on Medicaid rebates, and the Biden administration’s proposed draft guidance on patent “march-in” rights.

Read about how the removal of the average manufacturer price (AMP) cap on Medicaid rebates prompted manufacturers to cut insulin prices to avoid significant payments to Medicaid.

Mintz recently launched a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series highlights women leaders in the health care industry and includes discussions on key issues in the health care industry, women leaders’ reflections on their career, and the impact of mentorship. In our inaugural episode, Leah Pollema, Vice President and General Counsel at InhibRx, and Serene Katranji, Chief Operating Officer, Chief Compliance Officer, and Corporate Counsel at Orchard Laboratories, join host Bridgette Keller to share personal stories about their experiences as both mentees and mentors, shedding light on the invaluable impact mentorship has had on their professional journeys.

Mintz’s PBM & Pharmacy practice is proud to present the Mintz IRA Update, a regular publication that delves into the spectrum of developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health care industry.