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
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
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
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
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
On July 21, 2025, the U.S. District Court for the Southern District of Iowa issued a comprehensive preliminary injunction blocking enforcement of key provisions of Iowa Senate File 383 (the Act), a sweeping law aimed at...more
On June 11, 2025, Iowa enacted Senate File 383 (the Act), a comprehensive bill aimed at regulating pharmacy benefit managers (PBMs) with the stated goals of increasing transparency, supporting independent pharmacies, and...more
7/9/2025
/ Appeals ,
Constitutional Challenges ,
Drug Pricing ,
Healthcare Reform ,
Judicial Authority ,
New Legislation ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Preliminary Injunctions ,
Rebates ,
Reimbursements ,
State and Local Government ,
Transparency
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
Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...more
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
Last year was a pivotal year for the pharmaceutical industry. Under the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), the US government negotiated the prices of 10 selected high-expenditure,...more
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
The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more
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
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
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
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
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
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
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
9/18/2024
/ Compliance ,
Consumer Protection Act ,
Dispute Resolution ,
Drug Pricing ,
Healthcare Reform ,
HRSA ,
Pharmaceutical Industry ,
Pharmacies ,
PHRMA ,
Prescription Drugs ,
Section 340B ,
Unfair or Deceptive Trade Practices
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
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more
5/17/2024
/ Administrative Law Judge (ALJ) ,
Affordable Care Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Rules of Civil Procedure ,
Federal Rules of Evidence ,
Final Rules ,
HRSA ,
Office of Pharmacy Affairs (OPA) ,
Section 340B
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
The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task...more
4/19/2024
/ Anti-Kickback Statute ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare ,
Investigations ,
Legislative Agendas ,
Medicaid ,
Medicare ,
New Legislation ,
Qui Tam
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