D.C. Cir. Affirms Dismissal of Medical Product Maker’s Lawsuit

A three-judge federal appeals court panel on Friday affirmed a lower court’s decision to dismiss a medical product manufacturer’s lawsuit claiming the HHS improperly classified and reimbursed for company products without following proper procedures.

The decision by the US Court of Appeals for the District of Columbia held that the court didn’t have jurisdiction to decide the complaint by Regenative Labs, and that it should be “channeled through the Secretary’s administrative processes.”

Regenative Labs manufacturers products that contain human cells, tissues, and cellular or tissue-based products known as HCT/Ps.

In March 2022, the company sued Health and Human Services Secretary ...