News & Analysis as of

Section 340B Medicare Administrative Procedure Act

Epstein Becker & Green

HRSA Seeks Applicants to Test 340B Rebate Model Pilot Program

On August 1, 2025, the U.S. Department of Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) issued a call for applications for a 340B Rebate Model Pilot Program (the “Pilot Program”)....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

Foley & Lardner LLP

DC District Court Holds that Medicare Payment Cuts for 340B Drugs Exceeded Agency’s Authority

Foley & Lardner LLP on

Last week, a federal district court held that the Secretary of the Department of Health and Human Services (HHS) exceeded his authority when he reduced Medicare outpatient prospective payment system (OPPS) reimbursement to...more

Jones Day

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

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