The United States has reached a settlement with The Prometheus Group and its president, Richard Poore, over allegations of violating the False Claims Act. The company, located in New Hampshire, is accused of causing healthcare providers to bill Medicare for services where single-user rectal sensors and single-use catheters were improperly reused.
Acting U.S. Attorney for the Western District of Michigan Andrew B. Birge remarked, "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 importance of compliance, stating, "Manufacturers and providers must ensure that medical devices are utilized in a manner that ensures the safety of patients and complies with Federal laws and regulations."
Cheyvoryea Gibson, Special Agent in Charge of the FBI in Michigan, stated, "The FBI is committed to investigating bad actors and protecting the public from healthcare professionals and top executives who exploit the trust of patients by prioritizing greed and convenience over safe health practices."
The Prometheus Group, known for its pelvic muscle rehabilitation systems, allegedly encouraged the reuse of devices meant for single use, going against FDA regulations. This reuse was reportedly proposed to reduce overhead costs. These devices, specifically the Pathway CTS 2000 Pelvic Floor Training System and the Morpheus System, use rectal pressure probes and anorectal manometry catheters, which are considered a bio-hazard if reused, according to FDA guidelines.
The lawsuit suggests that Prometheus and its president were aware of these reuse restrictions yet advised healthcare providers to bypass them. Allegedly using barriers such as gloves or condoms to cover the probes exposed patients to a possible risk of infection and was not covered by Medicare as it was deemed unnecessary.
The lawsuit, United States v. The Prometheus Group., et al., No. 22-cv-446, was filed in the U.S. District Court for the Western District of Michigan. It was handled by Senior Trial Counsel Jay D. Majors and former Assistant U.S. Attorney Andrew J. Hull. Noteworthy is that the claims resolved by the settlement are allegations only, and there has been no determination of liability.
This outcome highlights the U.S. government's commitment to addressing healthcare fraud. The Department of Health and Human Services invites reports of potential fraud to 800-HHS-TIPS (800-447-8477). The investigation and resolution were a collaborative effort involving multiple federal agencies aiming to ensure the integrity of the medical system.
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