Xavier Hardy at Mintz

Mintz IRA Update — 340B Roundup: States and Manufacturers Continue to Battle over 340B Contract Pharmacies

Over the last two and a half years, the management of the 340B program has increasingly come under legislative and regulatory scrutiny as hospitals and manufacturers dispute the role of contract pharmacies. As we’ve...more

9/16/2025 / Appellate Courts , Department of Health and Human Services (HHS) , Drug Pricing , Enforcement Actions , Manufacturers , Pharmaceutical Industry , Pharmacies , Section 340B , State and Local Government , State Legislatures

Mintz IRA Update — Still Undefeated: Government Notches Three More Victories in Negotiation Program Lawsuits

As we wrote in May, the Third Circuit handed down the first appellate decision on the merits of manufacturers’ claims. In affirming the trial court and rejecting claims by AstraZeneca that the Negotiation Program violated its...more

9/16/2025 / Administrative Procedure Act , Appeals , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Drug Pricing , First Amendment , Inflation Reduction Act (IRA) , Medicare , Pharmaceutical Industry , Takings Clause

Mintz IRA Update — 340B Roundup: CMS Proposes Steeper OPPS Clawbacks, Launches Drug Cost Survey with Public Comment

In July 2025, CMS issued its 2026 Hospital Outpatient Prospective Payment System (OPPS) proposed rule, which includes two significant 340B policies. First, it includes cuts in the OPPS rates paid to hospitals to accelerate...more

9/16/2025 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Care Providers , Hospitals , Medicare , Outpatient Prospective Payment System (OPPS) , Proposed Rules , Public Comment , Rulemaking Process , Section 340B

Mintz IRA Update — Under Pressure: The Trump Administration’s Drug Pricing Executive Orders

On January 29, 2025, the Center for Medicare & Medicaid Services (CMS) released a statement highlighting that “[l]owering the cost of prescription drugs for Americans is a top priority of President Trump and his...more

9/16/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Inflation Reduction Act (IRA) , Medicaid , Medicare , Most-Favored Nations , Pharmaceutical Industry , Trump Administration

Mintz IRA Update — 340B Roundup: HRSA Launches 340B Rebate Model Pilot Program Amid Ongoing Legal and Regulatory Shifts

On July 31, 2025, the Health Resources and Services Administration (HRSA) released long-awaited guidance establishing a 340B Rebate Model Pilot Program (Pilot Program). The announcement marks a pivotal moment in the evolution...more

9/16/2025 / Centers for Medicare & Medicaid Services (CMS) , Covered Entities , Department of Health and Human Services (HHS) , Drug Pricing , HRSA , Inflation Reduction Act (IRA) , Manufacturers , Medicare Part D , New Guidance , Section 340B

Mintz IRA Update — 340B Roundup: Senate HELP Committee’s Long-Awaited 340B Report Highlights Ongoing Problems but Provides Few...

On April 24, 2025, the Senate Health, Education, Labor & Pensions (HELP) Committee, led by Sen. Bill Cassidy (R-La.), released a report on its investigation into the 340B program. The investigation, which began in 2023,...more

9/16/2025 / Covered Entities , Department of Health and Human Services (HHS) , Drug Pricing , Healthcare , HRSA , Pharmaceutical Industry , Pharmacies , Pharmacy Benefit Manager (PBM) , Reporting Requirements , Section 340B

PBM Policy and Legislative Update — Spring 2025

Mintz’s Managed Care Practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition breaks down the key federal and state legislative developments shaping the PBM landscape this...more

6/11/2025 / Drug Pricing , New Legislation , Pharmacy Benefit Manager (PBM) , Regulatory Reform , State and Local Government

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

5/13/2025 / Administrative Procedure Act , Appeals , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Drug Pricing , Inflation Reduction Act (IRA) , Judicial Review , Medicare , Pharmaceutical Industry , Prescription Drugs

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

5/1/2025 / Department of Health and Human Services (HHS) , Department of Labor (DOL) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicaid , Medicare , Pharmacy Benefit Manager (PBM) , Trump Administration

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

3/25/2025 / Affordable Care Act , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , DACA , Department of Health and Human Services (HHS) , Enrollment , Federal Poverty Line , Gender Identity , Health Insurance , Healthcare Reform , Inflation Reduction Act (IRA) , Insurance Industry , Out-of-Pocket Expenses , Proposed Rules , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

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

3/20/2025 / Alternative Payment Models (APM) , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , CMMI , ESRD , Healthcare Reform , Medicaid , Medicare , MedPAC , Trump Administration , Value-Based Care

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

2/14/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Chevron Deference , Constitutional Challenges , Loper Bright Enterprises v Raimondo , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , SCOTUS

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

2/14/2025 / Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Regulatory Agenda , Regulatory Requirements , Supply Chain

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

2/12/2025 / Compliance , Federal Trade Commission (FTC) , Final Rules , Health Insurance , Healthcare , Legislative Agendas , Medicaid , Medicare , Pharmacy Benefit Manager (PBM) , Proposed Rules , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

[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

2/4/2025 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Health Insurance , Medicare , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Regulatory Requirements , Value-Based Care

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

2/4/2025 / Centers for Medicare & Medicaid Services (CMS) , Health Insurance , Healthcare , Pharmacy Benefit Manager (PBM) , Regulatory Requirements , Value-Based Care

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

11/25/2024 / Audits , CVS , Drug Pricing , Federal Trade Commission (FTC) , Pending Litigation , Pharmacy Benefit Manager (PBM) , PHRMA , Policies and Procedures , Prescription Drugs , Proposed Legislation , Rebates , Settlement , Transparency

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

11/20/2024 / American Hospital Association , Audits , Department of Health and Human Services (HHS) , HRSA , Johnson & Johnson , Medicare , Medicare Part B , Section 340B

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

10/30/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Manufacturers , Medicaid , Prescription Drugs , Rebates , Section 340B

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

8/1/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Supply Chain , Telehealth , Transparency

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

7/16/2024 / AstraZeneca , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Dismissals , Drug Pricing , Fifth Amendment , Inflation Reduction Act (IRA) , Infringement , Medicare , Negotiations

Xavier Hardy

Mintz

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