GREENSBORO, N.C. - Bioventus, LLC, a global medical technology company, has agreed to pay the government $3,609,087.00 to resolve allegations that Bioventus violated the False Claims Act by submitting improperly completed certificates of medical necessity (CMN) for medically unnecessary devices from October 1, 2012 through December 31, 2018, U.S. Attorney Matthew G. T. Martin for the Middle District of North Carolina announced.
This settlement results from a self-disclosure to the Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG), which was later transferred to the U.S. Attorney’s Office for the Middle District of North Carolina. Bioventus made the written self-disclosure on November 30, 2018 relating to its Exogen device, an ultrasonic bone growth stimulator. Bioventus disclosed that it had discovered its sales representatives were sometimes completing Section B of the CMN for Exogen devices from October 1, 2012 through September 30, 2018. Medicare requires that Section B of the CMN be completed by the treating physician or the physician’s office. Bioventus completed a review of such claims with improperly completed CMNs to verify the medical records supported the medical necessity of the Exogen devices. Bioventus fully cooperated with the government’s investigation of the self-disclosure.
“Medicare funds must only be appropriately dispensed for medically necessary purposes and to those who comply with all rules and regulations,” said Matthew G.T. Martin, United States Attorney for the Middle District of North Carolina. “We appreciate Bioventus’s disclosure of these issues and hope this matter reminds other Medicare enrollees that they must have internal controls in place to ensure proper compliance with Medicare. Better to catch it and self-disclose than for us to discover it and come calling”
The settlement in this matter was the result of a coordinated effort by the U.S. Attorney’s Office for the Middle District of North Carolina and HHS-OIG.
“Medicare rules on medical necessity are enforced to protect patients and the integrity of this federal health care program,” said Derrick L. Jackson, Special Agent in Charge for HHS-OIG. “We encourage providers to voluntarily disclose evidence of potential fraud, as in this case, to resolve these matters.”
Medicare enrollees may self-disclose evidence of potential fraud to HHS-OIG. The Provider Self-Disclosure Protocol (SDP) provides Medicare enrollees with a framework for disclosing, coordinating, evaluating, and resolving potential instances of fraud involving Federal health care programs.