Known for its aesthetics and wellness culture, California continues to be a leading destination for new wellness and medical aesthetics practices (collectively, medical spas). Yet, unlike other states previously discussed in...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
California legislative activity focused upon private equity (PE) group and hedge fund health care transactions has continued notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129...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
In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate Hassan Shaikh for a discussion on noteworthy developments relating to the IRA and drug pricing. Together, Bridgette and Hassan...more
In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate Hassan Shaikh for a discussion on noteworthy developments relating to the IRA and drug pricing....more
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
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On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for the third cycle of the IRA’s Medicare Drug Price Negotiation Program (Negotiation Program). This draft guidance (Draft Guidance)...more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
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
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
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 January 13, 2025, California Attorney General Rob Bonta (the California AG) issued two Legal Advisories regarding the utilization of artificial intelligence (AI). The first Legal Advisory provides guidance to consumers and...more
1/23/2025
/ Artificial Intelligence ,
California ,
Compliance ,
Data Privacy ,
Health Insurance ,
Healthcare ,
Patient Privacy Rights ,
Privacy Laws ,
State Attorneys General ,
Transparency ,
Unfair Competition Law (UCL)
Governor Newsom signed over 1300 bills and vetoed almost 190 bills in 2024. Consistent with prior years, in 2024, California enacted multiple laws significantly impacting the health care industry. From artificial intelligence...more
12/27/2024
/ Artificial Intelligence ,
California ,
CLIA ,
Compliance ,
Enforcement Actions ,
Healthcare ,
Legislative Agendas ,
Medicaid ,
Medical Debt ,
Medicare ,
Prior Authorization
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
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
The Federal Trade Commission (FTC) Office of Policy Planning released an Interim Staff Report titled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies (the Interim...more
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