Mintz IRA Update — Fourth Edition: Q1 2025
Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022 (IRA) and their impact on pharmaceutical supply chain stakeholders.
To help our clients track and stay up to date with the developments related to the IRA, the Mintz IRA Update provides informed and insightful analyses on the issues that directly affect your business.
In this edition of the Mintz IRA Update, which covers developments through January 2025, you’ll find the following articles:
- The IRA in 2025: The Future of Medicare Part D
A discussion on the impacts seen from the implementation of initial elements to the Medicare Part D redesign, plus an overview of Part D redesign changes to watch for in 2025. - The Future of the Medicare Drug Price Negotiation Program
An exploration of changes made by CMS to the Medicare Drug Price Negotiation Program (Negotiation Program) following the inaugural round of negotiations, industry stakeholder reactions to such changes, and potential paths forward for the program under a second Trump administration. - A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges
A detailed summary of developments in several Negotiation Program lawsuits and an analysis of the impact Loper Bright and the second Trump administration may have on the Negotiation Program and its challenges. - Duplicate Discounts Between the 340B Drug Program & Medicare Drug Price Negotiation Program
An overview of the nonduplication challenges manufacturers and other stakeholders may face when administering the Maximum Fair Price requirements of the Negotiation Program and 340B pricing requirements. - Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program
A summary detailing certain clarifications made by CMS regarding the Medicare Prescription Payment Plan program and an overview of the final rule for the Medicare Inflation Rebate Program. - From the Desk of ML Strategies: The Medicare Drug Price Negotiation Program Under the Second Trump Administration
A discussion about how Donald Trump’s second presidency and Republican control in the 119th Congress could impact the IRA’s Medicare Drug Price Negotiation Program.
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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 Rachel Alexander, Theresa Carnegie, Tara Dwyer, or Lauren Moldawer for more information.
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!
— Rachel A. Alexander, Theresa C. Carnegie, Tara E. Dwyer, & Lauren M. Moldawer
Authors
Rachel A. Alexander
Member
Rachel A. Alexander, a Member at Mintz, is a seasoned health law attorney and litigator who represents health plans, payors, and managed care entities in all aspects of managed care and payor regulatory, transactional, and litigation matters. She has a specialized focus on pharmacy benefit and drug pricing–related issues. She is regularly called on to help clients navigate pharmacy benefit manager (PBM) contract negotiation, administration, and procurement matters and provide guidance on compliance with federal law.
Theresa C. Carnegie
Member
Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.
Tara E. Dwyer
Member
Tara advises managed care organizations, pharmaceutical services providers such as PBMs, and integrated delivery systems, and companies that invest in them, on matters relating to compliance with federal health care program regulations, federal and state fraud, waste and abuse laws and plan benefits.
Lauren M. Moldawer
Member
Lauren advises pharmacies, PBMs, managed care organizations, and other payors on transactional, regulatory, and fraud and abuse matters, drawing upon her experience working for the Federal Coordinated Health Care Office.
Hassan Shaikh
Associate
Hassan advises a broad range of clients across the health care industry—including health care systems, pharmacies, and private equity firms investing in health care companies—in complex industry transactions and compliance and regulatory matters.
Stephnie A. John
Associate
Stephnie advises clients across the health care industry on regulatory, transactional, and compliance matters.
Madison M. Castle
Associate
Madison M. Castle is an Associate at Mintz who focuses her practice on health care regulatory, transactional, and enforcement defense matters. She represents clients across the health care sector, including hospitals, physician organizations, and health care systems.
Mitchell J. Clough
Associate
Mitchell focuses his practice on complex commercial litigation, antitrust matters, and class actions in federal and state courts.
Xavier G. Hardy
Associate
Xavier represents clients in the health care and life sciences fields on health care regulatory and fraud and abuse matters. He also handles Medicare and Medicaid reimbursement issues in transactions and business arrangements.
Samantha Hawkins
Associate
Samantha Hawkins is an Associate at Mintz whose practice encompasses a broad range of complex transactions, compliance and regulatory issues, and governance matters for clients across the health care sector, with an emphasis on pharmacy benefit manager (PBM) contract negotiation.
Alexander Hecht
ML Strategies - Executive Vice President & Director of Operations
Alexander Hecht is Executive Vice President & Director of Operations of ML Strategies, Washington, DC. He's an attorney with over a decade of senior-level experience in Congress and trade associations. Alex helps clients with regulatory and legislative issues, including health care and technology.
Abdie Santiago
Associate
Abdie Santiago is an Associate at Mintz who represents life sciences and health care companies in a broad spectrum of regulatory, fraud and abuse, and transactional matters. He assists clients with government drug pricing mandates, Medicare and Medicaid coverage requirements, Anti-Kickback Statute and False Claims Act investigations, and due diligence for health care practice transactions.