Diagnostic Lab Testing Company to Pay $2 Million to Settle False Claims Act Allegations Related to Unnecessary Breast Cancer Testing
Seattle Whistleblower Attorneys report that diagnostic laboratory testing company, Biotheranostics Inc., agreed to pay $2 million to resolve allegations that it submitted and caused the submission of false claims to Medicare for Breast Cancer Index (BCI) tests that were not reasonable and necessary for the diagnosis and treatment of breast cancer.
By statute, Medicare can only pay for laboratory tests that are reasonable and necessary for the diagnosis or treatment of a patient’s illness or injury. The United States alleged that Biotheranostics knowingly promoted and performed the BCI test for breast cancer patients who had not been in remission for five years and who had not been taking tamoxifen, and thus for whom the test was not reasonable and necessary based on published clinical trial data and clinical practice guidelines.
The claims settled by this agreement are allegations only; there has been no determination of liability.
Source: Dept. of Justice
By statute, Medicare can only pay for laboratory tests that are reasonable and necessary for the diagnosis or treatment of a patient’s illness or injury. The United States alleged that Biotheranostics knowingly promoted and performed the BCI test for breast cancer patients who had not been in remission for five years and who had not been taking tamoxifen, and thus for whom the test was not reasonable and necessary based on published clinical trial data and clinical practice guidelines.
The claims settled by this agreement are allegations only; there has been no determination of liability.
Source: Dept. of Justice