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Stakeholders Raise 340B Concerns in Medicaid Drug Rebate Program Final Rule; CMS, With Hands Tied, Shrugs

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

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 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

Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception

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 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

HHS Court Filings Indicate that Agency Intends to Preserve Copay Accumulators

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

Trump Administration Releases Series of Executive Orders on Drug Pricing

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more

CMS Proposes Changes to Medicare Advantage Program for CY 2020

CMS recently proposed several important changes for the Medicare Advantage ("MA") program that relate to payment, benefit design, and new actions to combat the opioid crisis. These changes, among others, were proposed in...more

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