July 1, 2020

Genetic testing company Agendia, Inc., which offers the MammaPrint test analyzing genes within breast cancer tumors to predict recurrence, will pay $8.25 million to resolve claims of Medicare fraud in a case brought by a whistleblower under the False Claims Act.  Agendia was alleged to have conspired with hospitals to delay the performance of MammaPrint tests for patients discharged from those hospitals.  Under the Medicare 14-Day Rule in effect during the relevant time period, Agendia was allowed to bill Medicare directly for the test if it was performed more than 14 days after the patient was discharged from the hospital; if the test was performed within 14 days of discharge, then it would be billed through the hospital.  If Agendia received a physician’s order for a Medicare patient within 14 days of the patient’s discharge, it would either cancel the order and require the physician to resubmit it, or otherwise improperly delay the test and claim it was ordered and performed on a later date.  The whistleblower was a former employee of a Kentucky hospital, Mercy Health- Lourdes, which worked with Agendia to allow it to separately bill Medicare for the test, including by holding tissue specimens for 14 days or longer after patients were discharged. The hospital previously paid $211,039 to settle its liability.  No reward amount for the whistleblower was made public.  USAO WDKY

Tagged in: Bundling and Unbundling, FCA Federal, Healthcare Fraud, Laboratory and IDTF, Medical Billing Fraud, Whistleblower Case,