Health Care Viewpoints from Mintz: IRA Update Q1 2024 – Second Edition


Mintz’s PBMs & Pharmacies practice is excited to unveil the latest edition of our Mintz IRA Update. This publication explores the recent developments under the inflation reduction act of 2022 (“IRA”) that are impacting the healthcare sector.

The Impact of the IRA

The IRA stands as a landmark legislation concerning prescription drug pricing and coverage, rivaling the significance of the creation of Medicare Part D. It has the potential to reshape the Medicare drug pricing landscape, affecting manufacturers, PBMs, payors, pharmacies, and federal healthcare program beneficiaries.

Staying Updated

For our clients looking to stay informed about the IRA, the Update offers in-depth analyses of current healthcare-related developments. These insights shed light on key issues directly impacting your business. Expect forthcoming editions of the Update and other valuable IRA-related resources throughout the year.

Key Highlights

This edition of the Update features discussions on various IRA initiatives, including negotiations between CMS and manufacturers under the Medicare Drug Price Negotiation Program. Additionally, it covers Part D benefit design changes, inflation rebate programs under Parts B and D, legal challenges against the Negotiation Program, the IRA’s small biotech exemption, the implications of removing the AMP-cap from the Medicaid Drug Rebate Program, and the Biden administration’s draft guidance on patent “march-in” rights.

Personalized Information Sessions

Recognizing the IRA’s significance, we offer clients personalized sessions to discuss the short- and long-term impacts of the legislation. To schedule a session, please reach out to Theresa Carnegie, Tara Dwyer, or Rachel Alexander using the contact information provided below.

Feedback and Subscription

We trust that you will find the Mintz IRA Update to be a valuable resource. Your feedback is important to us, so please share any suggestions for additional content you would like to see in future editions. Subscribe to receive upcoming editions here.

— Theresa Carnegie, Tara Dwyer, & Rachel Alexander


The IRA in 2024: The Medicare Drug Price Negotiation Program in Full Swing and Other Developments

Legal Challenges to the Medicare Drug Price Negotiation Program Continue

Demystifying the IRA’s Small Biotech Exemption

Removal of AMP-Cap on Medicaid Rebates Causes Insulin Price Decrease

Biden Administration Proposes Allowing Agencies to ‘March-In’ to Control Rising Drug Prices

PhRMA CEO Stephen Ubl, in conversation with Bloomberg Law, highlighted the evolving landscape where HHS is playing a more prominent role in product pricing. He also mentioned the potential for a new wave of lawsuits against the Medicare Drug Price Negotiation Program. Read more here.

What We Are Reading

The Battle over Prescription Drug Prices Is Heating Up Fast Company | February 12, 2024 Read here …

A Sweeping New Lawsuit Against J&J Asks: Are Employers Liable if They Overpay for Drugs? STAT | February 5, 2024 Read here …

Two Commentaries on the Implementation of the IRA-Mandated Medicare Drug Price Negotiation Program Value in Health | December 5, 2023 Read here …

How Trump Could Weaken Medicare Drug Pricing Negotiations Axios | February 7, 2024Read here …

The Lone Democrat Willing to Weaken Medicare’s Power to Negotiate Drug Prices STAT | February 5, 2024 Read here …

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Read More of this Story at – 2024-03-14 22:14:35

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