News & Analysis as of

Manufacturers Rebates

Jones Day

HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models

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The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Goodwin

Federal Court Affirms HRSA Authority to Preapprove 340B Rebate Models but Urges HRSA to Reconsider Rejection of Rebate Model

Goodwin on

In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more

Quarles & Brady LLP

The 340B Program in 2024: A Tumultuous Year in Review

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The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more

Mintz - Health Care Viewpoints

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

Stevens & Lee

FTC Files Suit Against the Three Largest Pharmacy Benefit Managers

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The Federal Trade Commission (FTC) recently sued the three largest pharmacy benefit managers (PBMs) – Caremark Rx, Express Scripts (ESI) and OptumRx – alleging that the PBMs and their related group purchasing organizations...more

Mintz - ML Strategies

Businesses to Get Boost from $8.8B Home Energy Rebates Program — Home Energy Rebates Demystified (Part 1)

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For firms in the United States, the Inflation Reduction Act (IRA) has released a flood of funding for clean energy demonstration and deployment. Tens of billions of dollars in the form of direct grants and loans have been...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

Ankura on

On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases First Set of Part B Rebatable Drugs for Coinsurance Adjustment Under IRA

The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the...more

Foley & Lardner LLP

Tax Credits in the Inflation Reduction Act Aim to Build a More Equitable EV Market

Foley & Lardner LLP on

In February of this year, it was high time for me to buy a new car. I had driven the same car since 2008, and getting this-or-that replaced was costing more and more every year. As a first-time car buyer, I had two criteria:...more

Parker Poe Adams & Bernstein LLP

South Carolina Passes Targeted Tax Reform Legislation

The South Carolina General Assembly passed tax reform legislation providing targeted relief to individuals and to manufacturers, including (i) a one-time rebate of up to $700 in 2021 taxes for individuals; (ii) cuts to the...more

Cozen O'Connor

Mississippi AG Sues Manufacturers Over Alleged Insulin Pricing Scheme

Cozen O'Connor on

Mississippi AG Lynn Fitch sued drug manufacturers and pharmacy benefit managers (“PBMs”) for allegedly working together to manipulate and inflate insulin prices in violation of the Mississippi Consumer Protection Act and...more

Rivkin Radler LLP

Bristol-Myers Squibb Settles MDRP Underpayment Claim For $75 Million

Rivkin Radler LLP on

The U.S. Department of Justice recently announced that Bristol-Myers Squibb (BMS) agreed to pay $75 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate...more

Patterson Belknap Webb & Tyler LLP

Two District Courts Address Challenges to EpiPen Manufacturer Rebates

Recent decisions in two different antitrust cases involving price increases and marketing practices for the EpiPen address a relationship solidly embedded in the current architecture of pharmaceutical drug markets: payments...more

Eversheds Sutherland (US) LLP

Electric vehicle incentives in Georgia

With interest and investment in electric vehicle (EV) technology increasing steadily, it is important for OEMs, suppliers, dealers, and consumers to be aware of federal and state incentives that may subsidize their particular...more

Foley Hoag LLP - Medicaid and the Law

CMS Reneges on Historic “Grand Bargain” with Manufacturers in Tennessee Wavier Approval

Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more

Patterson Belknap Webb & Tyler LLP

Does HHS’s Elimination of the Safe Harbor for Manufacturer Rebates Leave Manufacturers with Increased Antitrust Risk?

On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...more

K&L Gates LLP

OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts...

K&L Gates LLP on

On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more

Baker Donelson

HHS/OIG Finalizes Rule Stripping PBM Rebates of Safe Harbor Protection

Baker Donelson on

On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

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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

Burr & Forman

South Carolina Issues Sales Tax Ruling Taxing Tobacco Rebates/Refunds

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The South Carolina Department of Revenue (DOR) has issued a proposed Revenue Ruling which will have a significant impact on South Carolina tobacco retailers, if finalized in its present form. The proposed Revenue Ruling, to...more

Foley & Lardner LLP

Driving the Future of Automotive Technology

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Powering the future is now! Electric vehicles (EVs) and self-driving cars (AVs) are two of the most innovative technologies in the history of the automotive industry....more

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