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PBM Policy and Legislative Update — Fall 2024

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

[Podcast] Health Law Diagnosed – Women Leaders in Health Care: Investing in Women’s Health

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

Health Law Diagnosed – Women Leaders in Health Care: Investing in Women’s Health

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

PBM Policy and Legislative Update — Summer 2024

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

PBM Update: Special Edition - FTC 6(b) Interim Staff Report and Activity

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

PBM Policy and Legislative Update — Winter 2024

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

CMS Publishes Final Rules Implementing Part C and Part D Program Changes

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

PBM Policy and Legislative Update - Winter 2024

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

Health Law Diagnosed – Women Leaders in Health Care: The Emerging Role of AI in Health Care

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 IRA Update — Removal of AMP-Cap on Medicaid Rebates Causes Insulin Price Decrease

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 IRA Update — Second Edition: Q1 2024

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

Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more

Health Law Diagnosed — Mintz Health Law Team: Reflecting on What We Are Grateful For

As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and...more

Health Law Diagnosed – Women Leaders in Health Care: The Role and Importance of Mentorship

In this episode, host Bridgette Keller introduces a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series will bring together women leaders for discussions on timely key issues and...more

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

Bipartisan legislative activity related to pharmacy benefit manager (PBM) oversight is at an all-time high in both the House and Senate. As we noted last week, several bills that address PBM activities are moving through the...more

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

Senate HELP Committee Eyes Drug Pricing and PBM Regulation Beyond Federal Programs

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more

PBM Regulatory Roundup (Fall 2022): State Medicaid Enforcement Efforts Continue As Legislative Activity Slows Down

Though the flurry of state PBM-focused legislation slowed down with the summer recess, there has still been plenty of noteworthy PBM news. This roundup focuses on state Medicaid enforcement activities involving Centene and...more

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more

PBM Regulatory Roundup (Summer 2022): States Continue PBM Oversight Activities

2022 continues to see a surge in state-led PBM enforcement efforts. This roundup provides a brief summary of Louisiana’s complaint against United Healthcare and OptumRx related to its Medicaid program and recent state...more

PBMs Continue to Draw Federal Scrutiny: PBM Transparency Act of 2022

As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit...more

CMS Moves Forward with its D-SNP Proposals in its CY 2023 Medicare Advantage and Part D Final Rule

Continuing our series discussing the CY 2023 Medicare Advantage and Part D Final Rule (Final Rule), this post focuses on the D-SNP related provisions under the Final Rule. As we discussed, the Centers for Medicare & Medicaid...more

Final Medicare Advantage and Part D Rule will Likely Require Medicare Advantage Plans to Update 2023 Bids under Maximum...

The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last...more

OIG Says that Increasing Use of Biosimilars Could Reduce Part D Spending

Last month, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a report finding that Medicare Part D, and Medicare beneficiaries, could reduce spending with increased use of...more

PBM Regulatory Roundup (Spring 2022): The 8th Circuit Rules and More States Issue Regulations

As states move forward with their 2022 legislative sessions in earnest, we have been examining whether the Pharmaceutical Care Management Association (PCMA) v. Wehbi decision has had any initial effects on PBM-focused...more

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