$1.99 Million Settlement for False Billing of Genetic Tests

Case: In a case that began as a whistleblower suit filed by two ex-employees, GenomeDx Biosciences has agreed to shell out $1.99 million to settle charges of improperly billing Medicare for its Decipher Biopsy which predicts the probability of prostate cancer metastasizing after surgery and classifies the tumor’s aggressiveness. The feds claim that over a nearly two-year period, beginning in September 2015, the San Diego-based genetic testing company made claims for Decipher tests performed on patients who didn’t have risk factors making the tests medically necessary. The whistleblowers will get $350K of the settlement. Significance: Decipher, which is based on the level of expression for 22 RNA biomarkers involved in prostate cancer pathways, has gained favor with a growing number of payors, including Cigna. In 2015, Medicare approved coverage but only for a limited subset of patients, i.e., those with: i. pathological stage T2 disease with a positive surgical margin; ii. pathological stage T3 disease; or iii. rising prostate-specific antigen levels after an initial PSA nadir. The patients GenomeDx billed for allegedly lacked the risk factors spelled out in the coverage policy.