WASHINGTON – Medtronic Inc. of Fridley, Minn., has agreed to pay the United States $23.5 million to resolve allegations that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the company’s pacemakers and defibrillators, the Justice Department announced today.
Post-market studies are intended to assess the clinical performance of a medical device or drug after that device or drug has been approved by the Food and Drug Administration. Registries are collections of data maintained by a device manufacturer concerning its products that have been sold and implanted in patients.
The United States contends that Medtronic caused false claims to be submitted to Medicare and Medicaid by using two post-market studies and two device registries as vehicles to pay participating physicians illegal kickbacks to induce them to implant Medtronic pacemakers and defibrillators. Although Medtronic collected data and information from participating physicians, each of the studies and registries required a new or previous implant of a Medtronic device in each patient, and in each case Medtronic paid participating physicians a fee ranging from approximately $1,000 to $2,000 per patient. The United States contends that Medtronic solicited physicians for the studies and registries in order to convert their business from a competitor’s product and/or persuade the physicians to continue using Medtronic products.
“Patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,” said Tony West, Assistant Attorney General for the Civil Division. “Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.”
“Medicare and Medicaid beneficiaries depend on their physicians to make decisions based on sound medical judgment, especially when they are choosing which pacemaker or defibrillator to implant,” said B. Todd Jones, U.S. Attorney for the District of Minnesota. “Medical device manufacturers must not be permitted to use improper payments to cloud that judgment.”
“Today’s settlement highlights one of the key purposes of the Anti-Kickback law – to ensure that the judgment exercised by health care providers in treating Medicare and Medicaid patients is not influenced by unlawful payments,” said Benjamin Wagner, U.S. Attorney for Eastern District of California.
“Patients trust that decisions to implant certain pacemakers or other medical devices are based on their own health interests and not influenced by kickbacks,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “Companies distorting medical decision-making through kickbacks can expect that OIG investigators and our law enforcement partners will actively investigate and prosecute such unlawful conduct.”
The settlement resolves allegations contained in two whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in Minnesota and California, respectively. As part of today’s resolution, the whistleblowers will receive payments totaling more than $3.96 million from the federal share of the recovery.
This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover nearly $6.5 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are more than $8.5 billion.
This settlement was the result of an investigation by the Justice Department’s Civil Division, the U.S. Attorney’s Office for the District of Minnesota, the U.S. Attorney’s Office for the Eastern District of California, the Office of Inspector General at the U.S. Department of Health and Human Services and the FBI.