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GSK for the third time this year has announced refunds for overcharging 340B covered entities, this time for purchases during Q3 2020.

GSK Announces Third Round of Refunds This Year for 340B Overcharges

Drug manufacturer GlaxoSmithKline for the third time this year has announced refunds for overcharging 340B covered entities, this time for purchases of 16 NDCs during Q3 2020.

The U.S. Health Resources and Services Administration (HRSA) posted GSK’s notice to entities yesterday on the Office of Pharmacy Affairs website. The company said it recalculated its 340B ceiling prices for the products as a result of revised Medicaid drug rebate pricing data submitted to the Centers for Medicare & Medicaid Services.

The refunds are for NDCs of the inhaled medicines Anoro Ellipta (2), Arnuity Ellipta (5), Breo Ellipta (4), Incruse Ellipta (2), Trelegy Ellipta (2), and the injectable type 2 diabetes treatment Tanzeum (1).

GSK said in the notice it will send refund checks to entities owed $100 or more in aggregate. The notice includes contact information for entities that may be owed less than $100.

GSK this year previously announced refunds for overcharges on purchases of 16 NDCs during Q2 2020 and nine NDCs during Q1 2020.

In 2021 GSK announced refunds for overcharges on purchases of 17 NDCs during Q4 2019 and 26 NDCs during Q1 2019.

GSK is one of the 18 drug manufacturers that have imposed limits on 340B pricing when covered entities contract with outside pharmacies to dispense 340B-purchased drugs. It announced its policy in February.

In April 2019 HRSA launched a long-delayed secure website that gave entities access to manufacturers ceiling prices for covered outpatient drugs. HRSA launched the site in conjunction with its 2017 ceiling price calculation and manufacturer civil monetary penalties final rule. That rule took effect Jan. 1, 2019.

The number of manufacturer refund notices posted on the OPA website has increased each year since the final rule took effect and the pricing website went live: 8 notices in 2019, 15 in 2020, 18 in 2021, and 25 so far this year.

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