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
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
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
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
Today, the Centers for Medicare & Medicaid Services (CMS) released the first 10 drugs (“Listed Drugs”) that will be included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (“Negotiation Program”)....more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
9/13/2021
/ Biden Administration ,
Biosimilars Action Plan (BAP) ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Pharmaceutical Industry ,
Prescription Drugs
PCMA's lawsuit over the legality of the Trump-era drug price transparency rules is yet another battle in the on-going war in Washington over how to effectively address high drug prices. While Congress grapples with how to...more
On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more
7/20/2021
/ Antitrust Provisions ,
Biden Administration ,
Biosimilars ,
Competition ,
CREATE Act ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Pharmaceutical Industry ,
USPTO
On April 28, 2021, President Biden gave his first address to Congress and announced the American Families Plan (AFP or the Act). The AFP follows the 1.9 trillion-dollar stimulus, the American Rescue Plan Act, signed into law...more
President Trump has followed through on his threat to pharmaceutical manufacturers, signing new executive orders on Sunday that take a preliminary step toward the President’s goal of tying domestic drug prices to the prices...more
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
7/12/2019
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Safe Harbors ,
Secretary of HHS ,
Trump Administration
On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more
7/24/2018
/ Anti-Kickback Statute ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more
5/14/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
REMS ,
Section 340B ,
Trump Administration
Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices. CMS proposed to...more
Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would...more