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Justice Department: Biotheranostics violated U.S. law when it billed Medicare for unnecessary tests

By Mark Iandolo | May 3, 2018

WASHINGTON (Legal Newsline) — The U.S. Department of Justice announced April 9 that Biotheranostics Inc. will pay $2 million after allegedly submitting false claims to Medicare for Breast Cancer Index (BCI) tests that were not necessary.

“Health care providers are responsible for ensuring that the services they provide to Medicare beneficiaries are both reasonable and necessary,” Chad A. Readler, acting assistant attorney general of the Justice Department’s Civil Division, said in a statement. “Laboratories that knowingly submit claims for non-reimbursable services will be held accountable. 

The Justice Department alleges Biotheranostics ignored published clinical trial data and clinical practice guidelines when it gave BCI tests to breast cancer patients. These patients had not been in remission for five years and were not taking tamoxifen as the data and guidelines mandated. Therefore, Biotheranostic violated federal law when it billed Medicare for those tests.

“Fighting health care fraud will continue to be a priority of this office,” U.S. attorney Adam L. Braverman for the Southern District of California, said in a statement. “As this settlement demonstrates, we will vigorously investigate and hold responsible laboratories and other providers that choose to submit claims to federal health care programs for unauthorized or unnecessary services.”

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U.S. Department of Justice