NEW YORK (GenomeWeb) – GenomeDx Biosciences has agreed to pay $1.99 million to settle charges that it improperly billed Medicare for its Decipher Biopsy prostate cancer genomic classifier, the US Attorney's Office for the Southern District of California announced on Monday.
The federal government alleged that GenomeDx submitted claims to Medicare between September 2015 and June 2017 for the Decipher test that were not medically reasonable and necessary, in violation of the False Claims Act. According to the US Attorney's Office, the patients that GenomeDx submitted the claims on behalf of did not have risk factors that required the test. Specifically, they did not have pathological stage T2 disease with a positive surgical margin, pathological stage T3 disease, or rising prostate-specific antigen levels after an initial PSA nadir.
The allegations arose from a whistleblower lawsuit filed by two former employees of GenomeDx, Stephanie LaFleur and Corrine Vause, who will receive about $350,000 of the $1.99 million settlement.
GenomeDx is based in Vancouver, British Columbia, but also has operations in San Diego. The company did not respond to a request for comment.