Shortly following its announcement of sweeping changes to RADV audits, CMS shared industry guidance last week regarding upcoming deadlines for the submission of risk adjustment data corrections in advance of RADV sampling....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 May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced significant changes in its risk adjustment data validation (RADV) audits. The changes focus on speed, the volume of targeted contracts, and...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
In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds...more
In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds. She is...more
In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...more
3/12/2025
/ Acquisitions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Investors ,
Mergers ,
New Legislation ,
Private Equity ,
Regulatory Requirements ,
State and Local Government
In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...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
In the latest episode of Health Law Diagnosed, host Bridgette Keller dives into potential health care policy changes on the horizon following the November 2024 election. She is joined by Alex Hecht, ML Strategies Executive...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
In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, host...more
In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, host...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 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
On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining...more
4/24/2024
/ Agents ,
Beneficiaries ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Final Rules ,
Health Care Providers ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part C ,
Medicare Part D ,
Mental Health ,
Prescription Drugs ,
Social Security Act
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
In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, host...more
Insulin costs lowered to $35 dollars per month for many patients this year as three major insulin manufacturers — Sanofi, Novo Nordisk, and Eli Lilly — began offering price caps or savings programs.[1] This strategy was...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