On November 5, 2025, CMS published the CY 2026 Physician Fee Schedule Final Rule (Final Rule), which includes changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) in the context of Average Sales Price...more
On October 11, 2025, California Governor Gavin Newsom signed Senate Bill 41 (SB-41) into law, introducing a comprehensive set of new regulations for pharmacy benefit managers (PBMs) operating in the state. As part of the...more
The first week of October 2025 marked a significant shift in U.S. drug pricing policy as the Trump administration unveiled a series of sweeping actions to deliver on his promise to lower drug prices. From President Trump’s...more
10/8/2025
/ Direct to Consumer Sales ,
Drug Pricing ,
Executive Orders ,
International Trade ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Supply Chain ,
Tariffs ,
Trump Administration
As we discussed in a recently published post, the CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when...more
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
While the pharmaceutical industry has reacted negatively to President Trump’s May 12 “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order), manufacturers appear to...more
9/16/2025
/ Advertising ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Telehealth ,
Trump Administration
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
GLP-1 receptor agonists (GLP-1s) such as semaglutide, and dual agonists like tirzepatide, are transforming obesity treatment and reshaping the US health care landscape. Originally developed to manage type 2 diabetes, these...more
As US pharmaceutical manufacturers continue to lead biopharmaceutical research and development, they find themselves increasingly at odds with the nation’s shifting regulatory landscape — a reality underscored in a 2025...more
In follow-up to the May 12th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for...more
In a significant legal development, a federal judge has temporarily blocked Arkansas from enforcing Act 624. Act 624 prohibits pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state, effectively...more
The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...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
On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s...more
After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...more
On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or...more
5/7/2025
/ Acquisitions ,
Anti-Competitive ,
Competition ,
Drug Pricing ,
Healthcare ,
New Legislation ,
Permits ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
State and Local Government
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
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 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
On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more
1/27/2025
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Medicaid ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Requirements ,
Reporting Requirements ,
Transparency
On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more
1/24/2025
/ Competition ,
Cost-Sharing ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Health Insurance ,
Life Sciences ,
Mergers ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Reimbursements