Drug manufacturers Bristol Myers Squibb (BMS) and Merck are giving 340B covered entities refunds for overcharges on select products, according to public notices by the companies posted on the U.S. Health Resources and Services Administration (HRSA) website.
For the second time this year, BMS has notified 340B entities about refunds on a new dosage form of Opdivo, its infused immunotherapy treatment for several types of cancer. Its first notice came in March. The new notice is dated May 20.
The new refunds cover Opdivo purchases made during Q4 2021. BMS said it recalculated its provisional 340B ceiling price for the product for the quarter to incorporate actual Medicaid pricing that was unavailable at the time of the new NDC’s launch.
BMS said it determined the amount it owed to each affected entity and will provide them with wholesaler credits. The notice includes contact information for entities that believe they are due a refund but that do not get a credit by June 28.
Under a new policy that took effect March 1, BMS lets hospitals that lack an entity-owned pharmacy designate just one contract pharmacy to access 340B pricing on Opdivo and most other BMS medicines.
Merck, also for the second time this year, has notified 340B entities about refunds for overcharges on select products. All nine affected NDCs were sold during Q2 2019. Merck said its recalculated 340B ceiling prices are due to revised pricing data submitted to the U.S. Centers for Medicare & Medicaid Services. Merck’s first refund notice of 2022 was in February.
The company said it will contact entities if they are owed more than $10.00 across all the applicable NDCs. If an entity does not hear from Merck and believes it is owed a refund, Merck said it should contact the company at an email address listed in the notice.
Eight of the nine NDCs are for injection or infusion. The ninth, for Belsomra 5 mg tablets (for insomnia), appears to be covered under Merck’s conditions on 340B pricing when entities use contract pharmacies. Merck says that policy applies to drugs “predominantly dispensed through retail, specialty, and outpatient pharmacies.”