by Ben Vernia | April 20th, 2018
On April 19, the Department of Justice announced that San Diego, California-based Biotheranostics, Inc., had agreed to pay $2 million to resolve civil False Claims Act charges over the company’s breast cancer tests.
Biotheranostics Inc. has 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, the Department of Justice announced today. Biotheranostics is a diagnostic laboratory testing company located in San Diego, California.
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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.
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The case apparently arose from a government investigation, and not from a whistleblower’s qui tam lawsuit.
