A New Hampshire-based medical device manufacturer and its owner are accused of violating the False Claims Act by encouraging providers to improperly reuse single-user rectal sensors and single-use catheters on multiple patients.
The U.S. Justice Department alleged in a May 17 news release that the Prometheus Group and its owner Richard Poore knew for years of the FDA's restrictions on the devices but instructed providers to reuse them as a way to reduce the overhead cost of the company's pelvic muscle rehabilitation systems.
The Justice Department alleges that the reuse of these devices unnecessarily exposed Medicare beneficiaries to risks of serious bacterial, fungal and viral infections. Prometheus allegedly made no attempt to determine if the probes worked effectively when re-used under those conditions.
The reuse of these devices was not reasonable or medically necessary and ineligible for Medicare coverage, according to the news release.