The U.S. Health Resources and Services Administration has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.
HRSA posted its audit findings Nov. 15. “KVK-Tech failed to refund covered entities for charges that were more than the 340B ceiling price,” it said.
The wording HRSA used was unique. HRSA did not say it found that the company charged more than the 340B ceiling price. Rather, it said it found that KVK Tech “failed to refund covered entities” for charges above the ceiling price. HRSA has never before issued such a finding. When the overcharges occurred in relation to the failure to provide refunds, and whether HRSA previously told the company it had overcharged entities, is unclear.
HRSA also said KVK Tech had an incorrect record in the 340B program database, 340B OPAIS.
When HRSA releases manufacturer audit findings, it provides no information about the scope of overcharges. KVK Tech did not respond yesterday to an emailed request for comment.
HRSA now has released the results of all five manufacturer audits it conducted in fiscal year 2022. Three companies had to make repayments to entities.
AstraZeneca drug replenishment announcement
In an unrelated development, HRSA yesterday posted a notice from AstraZeneca to covered entities about the discontinuation of a tablet formulation of a cancer drug and its substitution with a capsule formulation.
The company said entities using virtual inventories could count accumulations of Calquence capsule NDC 0310-0512-60 toward replenishment of equal quantities of the corresponding Calquence tablet NDC 0310-3512-60.