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Trump Administration Issues Drug Pricing Executive Order

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including...more

What to Take Away from CMMI’s Early Termination of Four Demonstration Models

On March 12, 2025, in one of the Trump Administration’s first actions with respect to the Center for Medicare and Medicaid Innovation (CMMI), CMMI announced that it would prematurely terminate four alternative payment model...more

Mintz IRA Update — A Circuit Win and the End of Chevron Deference Could Shift Tides in Drug Price Negotiation Program Challenges

As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more

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...more

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

[Podcast] Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of...more

Health Law Diagnosed – New Year's Gratitude

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead....more

PBM Policy and Legislative Update — Fall 2024

Mintz’s PBM practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from July through September that affects the PBM industry....more

Unpacking Johnson & Johnson’s Lawsuit Over 340B Rebate Model

On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the United States District Court for the District of Columbia. The lawsuit...more

Stakeholders Raise 340B Concerns in Medicaid Drug Rebate Program Final Rule; CMS, With Hands Tied, Shrugs

On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). While not the focus of the agency’s rulemaking, stakeholders...more

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more

Mintz IRA Update — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more

The Uncertain Landscape of Medicare Agent/Broker Compensation Rules

In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and...more

PBM Policy and Legislative Update — Winter 2024

The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry. Our team actively...more

PBM Policy and Legislative Update - Winter 2024

The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry. Our team actively...more

Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program Continue

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more

Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception

On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more

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...more

Safeguarding Reproductive Rights

In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more

HHS Court Filings Indicate that Agency Intends to Preserve Copay Accumulators

As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...more

Court Strikes Down HHS Rule on Copay Accumulators: Implications for Health Plans and PBMs

In a significant development with far-reaching implications for health plans and pharmacy benefit managers (PBMs), Judge John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal...more

California Legislative Update Part II: Upcoming Changes for Health Facilities

Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, we summarize many of the laws relevant to health facilities, a number of...more

With Proposal to Cap Drug Price Increases, Massachusetts Once Again Takes Center Stage in the Drug Pricing Debate

On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more

Connecticut Proposal to Cap Drug Price Increases Could Portend a Shift in the Drug Pricing Debate

On March 15, 2022, a drug pricing bill proposed by Connecticut Governor Ned Lamont’s (S.B. 13) was referred to the state legislature’s nonpartisan legal counsel responsible for drafting and processing official legislation....more

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