This practice continued even though “Biotronik’s compliance and training departments warned that Biotronik’s salespeople had too much influence in the selection of Training Physicians, that the Training program and resulting payments were being overutilized, and that the goal of educating Biotronik employees could be achieved without paying Training Physicians.” Biotronik would, “in certain circumstances,” allow “trainees to attend an excessive number of training procedures for which Training Physicians received payment from Biotronik” without an initial assessment of if the trainees needed more training. alleged that “Biotronik knowingly paid excessive payments to physicians with a purpose of inducing and rewarding their use of Biotronik’s pacemakers, defibrillators, and other cardiac devices.” In particular, Biotronik allegedly “abused its new employee training program by knowingly paying some of its physician customers to provide excessive employee trainings.” The settlement agreement states that according to written agreements between Biotronik and the physician customers, the physicians, or Training Physicians, “were to be paid a fixed fee of approximately $400.00 each time a Biotronik employee trainee received training during one of the Training Physicians’ CRM implant procedures.” government intervened in the whistleblowers’ case in June of 2021. They alleged that Biotronik “knowingly caused the submission of false claims for payment to federal healthcare programs by providing remuneration to physicians to induce them to use Biotronik’s” cardiac rhythm management (CRM) devices, according to the settlement agreement. Jeffrey Bell and Andrew Schmid, who were both former “independent sales representatives for Biotronik,” filed a whistleblower lawsuit in March of 2018. Biotronik will “resolve allegations that it violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce their use of Biotronik’s implantable cardiac devices, such as pacemakers and defibrillators.” On July 22, the DOJ announced a $12.95 million settlement with Biotronik, Inc., an Oregon-based medical manufacturer. Companies that engage in this fraudulent conduct will be held accountable.” Biotronik Inc. “Prioritizing profit over complying with the law wastes hard earned taxpayer dollars. “Laboratories that bill for medically unnecessary tests drain funds from Medicare and other federally funded health care programs,” said U.S. The press release contains additional information, stating that with the settlement, “Inform admits that, between 20, it routinely and automatically conducted additional tests on biopsy specimens prior to a pathologist’s review and without an individualized determination regarding whether additional tests were medically necessary.” Thus, the government alleged that Inform caused false claims to be submitted to federal health care programs because some of the testing was medically unnecessary.įor their role in the case, the whistleblower will receive $2,720,000 from the U.S. According to the settlement agreement, a whistleblower filed a qui tam lawsuit in January of 2019 and alleged that Inform “violated the federal False Claims Act by submitting false claims to Medicare and other federally funded healthcare programs for non-payable, nonallowable laboratory services conducted without a treating physician’s order.” The whistleblower alleged that this behavior was “part of an improper upfront, preorder testing scheme.”Īccording to the whistleblower, “rather than perform only the test(s) ordered by the treating physician, Inform automatically and systematically ran additional tests, including special stains, without the treating physician’s knowledge, consent, or order, and without a pathologist’s determination of medical necessity.”
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