Mintz IRA Update — Third Edition: Q2 2024
Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Third Edition: Q2 2024’ 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.
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 drug pricing landscape with provisions that impact manufacturers, PBMs, payers, pharmacies, and plan beneficiaries. To help our clients track and stay up to date with the impacts of the IRA, the Mintz IRA Update analyzes current pharmacy supply chain related developments and 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 July 1, 2024, you’ll find the following articles:
- Learning From Experience: Medicare Drug Price Negotiation Program Updates
A discussion on the lessons learned by CMS and other industry stakeholders from the initial rollout of the Medicare Drug Price Negotiation Program and how it is expected to be revised for next year. - IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program
A status update on the current legal challenges and court decisions relating to the Negotiation Program. - The Consequences and Costs of Redesigning the Part D Program
An overview of the Part D benefit redesign and its consequences for Part D plans and drug manufacturers. - Opposition to the Use of March-In Rights to Lower Drug Prices
An update on the Biden administration’s controversial proposed draft guidance of “march-in” rights. - The Growing Use of State Prescription Drug Affordability Boards
An analysis of how state-mandated prescription drug affordability boards are being leveraged in the fight against high drug costs.
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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.
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.
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.
David R. Gilboa
Associate
David R. Gilboa is an Associate at Mintz whose practice encompasses transactional, compliance, privacy, and regulatory matters. He represents a broad spectrum of health care clients, including health care systems, hospitals, digital health companies, clinical laboratories, nursing homes, home care agencies, physician practices, and pharmacies.
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.
Stephnie A. John
Associate
Stephnie advises clients across the health care industry on regulatory, transactional, and compliance matters.
Bridgette A. Keller
Of Counsel
Bridgette advises health care providers, ACOs, health plans, PBMs, and laboratories on regulatory, fraud and abuse, and business planning matters, applying her experience in health system administration and ethics in health care to her health law practice.
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.
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.
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.