Novartis is putting conditions on refunds to 340B hospitals for overcharges on its second-best selling drug.

HRSA Posts Novartis Notice About 340B Refunds on a Top-Selling Drug—With Contract Pharmacy Strings Attached (Updated)

UPDATE Tuesday, July 27, 2021, 1:45 p.m. Eastern—Drug manufacturer Novartis provided the following statement:

“Novartis recently notified the Health Resources and Services Administration (HRSA) that we inadvertently neglected to offer the 340B ceiling price to covered entity types added by the Affordable Care Act (ACA) dispensing Gilenya (fingolimod) .5 mg capsules following our voluntary removal of Gilenya from the Orphan Drug Designation List on December 9, 2020. Novartis is now offering refunds to qualified covered entities that purchased .5 mg Gilenya capsules from December 9, 2020, to June 30, 2021, and will make the 340B ceiling price available to such entities on a going-forward basis as well.

The U.S. Health Resources and Services Administration (HRSA) has posted drug manufacturer Novartis’ public notice to certain 340B hospitals that they might be eligible for refunds for overcharges on the company’s second-best selling drug—but only if the purchases comport with Novartis’ 340B contract pharmacy policy, which HRSA has said is illegal.

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