Drug manufacturer Merck is providing refunds for charges above 340B ceiling prices on 23 NDCs purchased during Q4 2019, Q3 2021, and Q2 2022.
The U.S. Health Resources and Services Administration posted Merck’s Nov. 21 notice about the repayments on its website late last week. Merck said the refunds are due to revised pricing data submitted to the Centers for Medicare & Medicaid Services.
The products are a mix of oral and injectable drugs. They include the muscle relaxant reversal agent Bridion, one of Merck’s most profitable products ($762 million in U.S. sales in 2021).
Merck said covered entities owed an aggregate refund of $10 or more would be contacted about how the refund would be processed. The notice includes contact information for entities that believe they are owed a refund but that do not get a communication from Merck. Merck earlier this year announced refunds for 340B overcharges during Q1, Q2, and Q3 2019. It is one of the 19 manufacturers that have placed restrictions on the use of 340B discounts in the contract pharmacy setting. HRSA has told Merck its policy is illegal and Merck has sued in federal court to have HRSA’s violation letter struck down. Its cases has been stayed pending the outcome of a related case before a federal circuit court.