News & Analysis as of

Final Rules Prescription Drugs Pharmacy Benefit Manager (PBM)

Goodwin

Health Headlines: July 2025

Goodwin on

Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

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The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

King & Spalding

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

King & Spalding on

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

Wiley Rein LLP

Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?

Wiley Rein LLP on

In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more

Wiley Rein LLP

Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?

Wiley Rein LLP on

In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...more

White & Case LLP

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

White & Case LLP on

The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

Mintz - Health Care Viewpoints

HHS Issues Controversial Drug Rebate Reform Final Rule

Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...more

K&L Gates LLP

K&L Gates Triage: Looking Ahead to 2020: Developing Issues in Pharmacy Law and the 340B Drug Pricing Program

K&L Gates LLP on

In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Mintz - Health Care Viewpoints

CMS Finalizes Medicare Advantage and Part D Drug Pricing Rule

Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more

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