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
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
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
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
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
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
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
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 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
In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and...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
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 IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more
On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...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
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more
As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...more
In a significant development with far-reaching implications for health plans and pharmacy benefit managers (PBMs), Judge John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal...more
Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, we summarize many of the laws relevant to health facilities, a number of...more
12/21/2022
/ CDPH ,
Governor Newsom ,
Healthcare Facilities ,
Hospice ,
Hospitals ,
Licensing Rules ,
Long Term Care Facilities ,
Mental Health ,
New Legislation ,
Pharmacies ,
Skilled Nursing Facility ,
Substance Abuse
On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more
4/22/2022
/ Affordable Care Act ,
Drug Pricing ,
Governor Baker ,
Medicaid ,
Medicare ,
Medicare Part D ,
Penalties ,
Pharmacy Benefit Manager (PBM) ,
PHRMA ,
Price Inflation ,
Proposed Legislation ,
State Budgets