News & Analysis as of

Covered Entities Rebates Drug Pricing

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

King & Spalding

OPA Announces 340B Rebate Model Pilot Program

King & Spalding on

On July 31, 2025, HRSA’s Office of Pharmacy Affairs (OPA) announced a voluntary 340B Rebate Model Pilot Program (Pilot Program). Currently, under the 340B program, covered entities purchase outpatient drugs at a discounted...more

Polsinelli

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

Polsinelli on

Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

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

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

Dinsmore & Shohl LLP on

On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...more

K&L Gates LLP

K&L Gates Triage: 340B Update: State Medicaid 340B Billing Requirements

K&L Gates LLP on

In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These...more

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