Caris Life Sciences, Inc. has agreed to pay $2,886,674.86 to resolve allegations that it violated the False Claims Act in an alleged nationwide scheme to improperly bill Medicare for laboratory tests known as “Caris Molecular Intelligence” and the “ADAPT Biotargeting System.” Caris, a molecular science company headquartered in Texas, developed a series of laboratory tests primarily for cancer patients to detect the activity of certain genes within a breast cancer tumor to predict the risk of breast cancer recurrence in patients. These predictive genetic marker tests are used by oncologists and other physicians to assist in determining appropriate treatment options for cancer patients.
During the time period covered by the settlement, Medicare’s 14-Day Rule prohibited laboratories from separately billing Medicare for tests performed on specimens if a physician ordered the test within 14 days of the patient’s discharge from a hospital stay either in an outpatient or inpatient setting. However, if the test was performed more than 14 days after discharge, then Medicare’s 14-Day Rule permitted laboratories to bill Medicare directly for the test. The United States contends that Caris perpetrated a scheme to evade Medicare regulations when submitting claims to the Centers for Medicare & Medicaid Services (CMS) for its predictive marker tests to circumvent Medicare’s 14-Day Rule (which establishes who may bill Medicare for certain laboratory services) in three ways.
