Drug manufacturer Mallinckrodt’s SpecGx generic pharmaceutical subsidiary is providing refunds for 340B overcharges on 22 NDCs for purchases from Q3 2019 through Q2 2020.
This is the third time this month that a drug manufacturer has announced 340B refunds for overcharges. Amgen and GlaxoSmithKline were the others.
Mallinckrodt announced the refunds on a notice posted this week on the U.S. Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) website. It said the repayments are “due to revisions to the Medicaid pricing data for the period Q1 2019 through Q4 2019.”
Mallinckrodt, like Amgen and GSK, is issuing refunds on its own accord only if determines that an entity is owed refunds adding up to a threshold sum—in Mallinckrodt’s case, $50 or more (Amgen set the baseline at $25 and GSK at $100).
“If any entity believes it is owed a refund in the aggregate of less than $50.00 for 340B purchases of the impacted products set forth below for the restatement period and would like to request a refund, the entity should send an email to 340BRefunds@mnk.com,” Mallinckrodt’s notice said. “All refund submissions are requested by July 31, 2022, specifying the 340B ID, entity name and address, applicable NDC(s), purchase volume(s), purchase price(s) and time period(s). Upon validation of a refund submission, SpecGx will refund any overcharges.”
Mallinckrodt also said it “is not seeking reimbursement or repayment where covered entities paid a lower price than the recalculated 340B ceiling prices for the restatement period
and is not using any such amounts as offsets in determining the aggregate amount of any refund due.” Other manufacturers have begun adding similar language to their 340B refund notices about forgoing offsets when price restatements show entities paid below the recalculated ceiling prices.
Mallinckrodt’s SpecGx subsidiary last year provided refunds for 340B overcharges on about 150 NDCs purchased between Q1 2017 and Q1 2020. Mallinckrodt, which was once the nation’s leading seller of opioids, filed for bankruptcy protection in October 2020.
That same month, Mallinckrodt announced it was settling with the U.S. Department of Justice for $260 million over allegations the company evaded paying additional Medicaid rebate amounts due when a drug’s average manufacturer price (AMP) rises faster than inflation. The same inflation penalty also can cause a drug’s 340B ceiling price to fall, sometimes to a floor of $0.01. The payments will be allocated to states over seven years. 340B providers were not included in the settlement.