Mintz IRA Update — Second Edition: Q1 2024

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associated with removing the AMP-cap from the Medicaid Drug Rebate Program, and the Biden administration’s proposed draft guidance on patent “march-in” rights.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

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

Overheard

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 ...

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Mintz IRA Update — Inaugural Edition

September 20, 2023| Blog|

Authors

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 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 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.

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 focuses his practice on complex commercial litigation, antitrust matters, and class actions in federal and state courts.

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.

Stephnie advises clients across the health care industry on regulatory, transactional, and compliance matters.

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.

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 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.

Mintz IRA Update — Second Edition: Q1 2024

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