The United States government has reached a settlement with The Prometheus Group, a New Hampshire-based manufacturer of medical devices, and its owner, Richard Poore. The settlement resolves a civil lawsuit in which Prometheus was accused of violating the False Claims Act. The company and Poore have agreed to pay $550,000 to resolve the allegations.
The accusations against Prometheus include instructing healthcare providers to bill Medicare for services where single-user rectal sensors and single-use catheters were improperly reused on multiple patients. Acting U.S. Attorney for the Western District of Michigan, Andrew B. Birge, commented, "Medicare beneficiaries deserve treatment that is reasonable and safe. Device manufacturers and medical practitioners cannot flaunt the rules and jeopardize the wellbeing of patients in our community."
Mario M. Pinto, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General – Chicago Region, emphasized the necessity of using medical devices in compliance with federal regulations to ensure patient safety. In his words, "Our agency, working in conjunction with our law enforcement partners, will always work to hold those accountable who jeopardize patient safety or submit false claims to Federal health care programs."
Cheyvoryea Gibson, Special Agent in Charge of the FBI in Michigan, stated that the FBI is committed to investigating malpractice and protecting public health from individuals who prioritize personal gains over safety.
Prometheus produces device systems for pelvic muscle rehabilitation (PMR), with a focus on non-surgical therapies for pelvic floor disorders. These devices include the Pathway CTS 2000 Pelvic Floor Training System and the Morpheus System. Both systems utilize a rectal pressure probe, which is meant for single-user usage only, per FDA guidelines. However, the complaint alleges that Prometheus encouraged the reuse of these probes, covered with gloves or condoms, to save costs.
The U.S. Food and Drug Administration had previously cleared these rectal pressure sensors for single-use only due to potential bio-hazard risks. The lawsuit suggested that Prometheus's actions exposed patients to heightened risks of infections and that such reuse was not reasonable or necessary for Medicare coverage.
The resolution of this matter involved various branches of the Justice Department, including the Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Western District of Michigan. Additional assistance was provided by the Department of Health and Human Services, the FDA’s Office of Criminal Investigations, and the FBI.
The settlement underscores the government's ongoing efforts to combat healthcare fraud under the False Claims Act. While the allegations have been resolved, there has been no admission of liability by Prometheus. Complaints regarding potential fraud or abuse can be reported to the Department of Health and Human Services.
The case, filed in the U.S. District Court for the Western District of Michigan, is titled United States v. The Prometheus Group., et al., No. 22-cv-446 (W.D. Mich.).
The claims resolved by the settlement are allegations only, and there has been no determination of liability.
