Mintz’s PBMs & Pharmacies practice is pleased to present the second edition of our Mintz IRA Update, a regular publication that delves into developments under the Inflation Reduction Act of 2022 (“IRA”) impacting 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 — and has the potential to fundamentally change the Medicare drug pricing landscape with provisions that impact manufacturers, PBMs, payors, pharmacies, and federal health care program beneficiaries.
To help our clients track and stay up-to-date with the IRA, the Update analyzes current health care–related developments and provides informed and insightful analyses of the issues that directly affect your business. Look for future editions of the Update and other IRA-related resources throughout the year.
In this edition of the Update, you’ll find (i) a discussion of the status of the negotiations underway between CMS and manufacturers pursuant to the Medicare Drug Price Negotiation Program; (ii) analyses of other drug pricing–related IRA initiatives, including Part D benefit design changes going into effect this year and the inflation rebate programs under Parts B and D; (iii) a status update on the current legal challenges against the Negotiation Program; and (iv) overviews of the IRA’s small biotech exemption, the implications associated with removing the AMP-cap from the Medicaid Drug Rebate Program, and the Biden administration’s proposed draft guidance on patent “march-in” rights.
We also note that given the IRA’s importance, we offer clients personalized, one-on-one information sessions regarding the short- and long-term impacts of the IRA. If you are interested, please contact Theresa Carnegie, Tara Dwyer, or Rachel Alexander (contact information included further below).
We hope you find the Mintz IRA Update to be a useful resource. If you have any recommendations on additional content that would be helpful to see in future editions, please do not hesitate to reach out to our team to let us know.
We hope you enjoy, and please subscribe to receive future editions!
— Theresa Carnegie, Tara Dwyer, & Rachel Alexander
Contents
PhRMA CEO Stephen Ubl, speaking to Bloomberg Law, stated that “barring litigation or other substantial change,” the pharmaceutical industry is entering a phase where the HHS appears to be taking on a “much larger role” in the process for pricing products. “There is likely to be a second wave” of lawsuits against the Medicare Drug Price Negotiation Program, he noted, as reported 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, 2024
Read here ...
The Lone Democrat Willing to Weaken Medicare’s Power to Negotiate Drug Prices
STAT | February 5, 2024
Read here ...
[View source.]
