Mintz Health Care: Q1 2024 IRA Update – Second Edition

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TL/DR –

The Mintz law firm’s second edition of the Mintz IRA Update covers recent developments under the Inflation Reduction Act of 2022 (IRA) which greatly impacts the health care industry, particularly prescription drug pricing. The publication provides analysis of current health care-related matters such as the status of negotiations between CMS and manufacturers, drug pricing initiatives, and legal challenges against the Negotiation Program. Additionally, it offers overviews of the IRA’s small biotech exemption, implications of removing the AMP-cap from the Medicaid Drug Rebate Program, and the Biden administration’s proposed draft guidance on patent “march-in” rights.


Mintz’s PBMs & Pharmacies Practice Offers Insightful Updates on IRA Developments

Mintz’s PBMs & Pharmacies practice shares the second edition of the Mintz IRA Update, an insightful publication focusing on developments under the Inflation Reduction Act of 2022 (“IRA”) that influence the health care industry.

The IRA is transformative legislation for prescription drug pricing and coverage since the inception of Medicare Part D. It has the potential to reshape the Medicare drug pricing landscape, impacting manufacturers, PBMs, payors, pharmacies, and federal health care program beneficiaries.

The Update provides in-depth analysis of current health care-related developments, offering expert insights on the IRA issues affecting your business. Watch out for future editions of the Update and other IRA-related resources throughout the year.

In this edition, you’ll find a discussion on the status of CMS and manufacturers negotiations under the Medicare Drug Price Negotiation Program; analyses of other drug pricing-related IRA initiatives; a status update on legal challenges against the Negotiation Program; and overviews of the IRA’s small biotech exemption, removal of the AMP-cap from the Medicaid Drug Rebate Program, and the Biden administration’s proposed draft guidance on patent “march-in” rights.

Due to the IRA’s significance, we offer personalized, one-on-one information sessions on the IRA’s short- and long-term impacts. For more information, please contact Theresa Carnegie, Tara Dwyer, or Rachel Alexander.

Subscribe to the Mintz IRA Update here for future editions.

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

What We Are Reading

The Battle over Prescription Drug Prices Is Heating Up
Read here…

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

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