Mintz IRA Update: Second Edition for Q1 2024 – Perspectives on Healthcare from Mintz

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TL/DR –

Mintz’s PBMs & Pharmacies practice has released the second edition of its Mintz IRA Update, discussing the recent developments under the Inflation Reduction Act of 2022 (IRA) that impact the health care industry. The IRA is the most significant legislation relating to prescription drug pricing and coverage since the creation of Medicare Part D. The update covers various topics including the status of the negotiations between CMS and manufacturers, changes to Part D benefit design, the inflation rebate programs under Parts B and D, and the Biden administration’s proposed draft guidance on patent “march-in” rights.


Mintz’s PBMs & Pharmacies Practice Unveils Second Mintz IRA Update

Presenting the second edition of the Mintz IRA Update, an authoritative source on the Inflation Reduction Act of 2022 (“IRA”). This legislation, impacting prescription drug pricing and coverage, holds the potential to effect a paradigm shift in the Medicare drug pricing landscape, affecting manufacturers, PBMs, payors, pharmacies, and federal healthcare program recipients.

Tracking Developments with the Inflation Reduction Act

We analyze health care-related IRA developments to help businesses stay informed. This edition discusses the status of CMS’ negotiations with manufacturers, other drug-pricing IRA measures, the status of legal challenges against the Negotiation Program, and overviews of IRA’s small biotech exemption, AMP-cap removal implications for the Medicaid Drug Rebate Program, and the proposed draft guideline on patent “march-in” rights.

Personalized Information on IRA Impact

Given the IRA’s reach, we offer custom information sessions about the IRA’s short and long-term effects. To register, contact Theresa Carnegie, Tara Dwyer, or Rachel Alexander. We value your suggestions for future Mintz IRA Update issues – please subscribe to receive them!

Contents

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

Industry News

PhRMA CEO Stephen Ubl predicts a second wave of lawsuits against the Medicare Drug Price Negotiation Program, as mentioned here.

Recommended Reading

The Battle over Prescription Drug Prices Is Heating Up

A Sweeping New Lawsuit Against J&J Asks: Are Employers Liable if They Overpay for Drugs?

Two Commentaries on the Implementation of the IRA-Mandated Medicare Drug Price Negotiation Program

How Trump Could Weaken Medicare Drug Pricing Negotiations

The Lone Democrat Willing to Weaken Medicare’s Power to Negotiate Drug Prices

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