Endoscopy at the hospital. Doctor holding endoscope before gastroscopy. Instrument for endoscopy in the doctor's hands.
An official complaint was filed by the US Department of Justice in Western Michigan against a New Hampshire manufacturer of pelvic muscle therapeutic systems and rectal probes.
The complaint alleges that The Prometheus Group, and Richard Poore (president and owner), violated the False Claims Act by causing health care providers to bill Medicare for services in which the providers improperly re-used single-user rectal sensors and single-use catheters on multiple patients.
Reuse of these devices on multiple patients unnecessarily exposed vulnerable Medicare beneficiaries to the risks of serious bacterial, fungal and viral infections, the DOJ points out.
“The department will hold parties accountable for causing the use of unsafe procedures that may put patients’ health at risk,” Brian M. Boynton, assistant attorney general, said in a statement.
“The Medicare Program is designed to serve an already-vulnerable population,” Mark Totten, United States attorney for the Western District of Michigan, added in his own statement. “Device manufacturers must not train providers who bill Medicare for services to use devices in a way that fails to protect patient health.”
According to the FDA, instructions for use identify the rectal pressure sensor as “a potential bio-hazard” and state: “This sensor is restricted for single person use only. Use by another person is strictly prohibited by Federal Regulations.” Similarly, the anorectal manometry catheter was cleared by the FDA as a disposable single-use device, with packaging that states: “Do not re-use.”
The DOJ says The Prometheus Group knew of these restrictions, but for years encouraged and instructed health care providers to reuse the rectal pressure sensors and anorectal manometry catheters on multiple patients, using a glove or condom to cover the probes, as a way to reduce the overhead costs associated with Prometheus’s systems.
Dominic Genetti was born and raised in St. Louis and has been in the media industry since 2003. He holds a bachelor's degree in journalism from Northwest Missouri State University, and has covered a variety of subjects including hard news, courts, enterprise features, and sports. From 2011 to 2013, Genetti wrote a syndicated baseball column that published daily throughout the country. He was also awarded the "Community Service" award from the Missouri Press Association for his efforts to bring light to a historic cemetery in disrepair in Hannibal, Missouri. Multimedia coverage is also part of Genetti's repertoire. In 2011 he was named the GateHouse Media Videographer of the Year. Genetti has worked for newspapers in Missouri, Iowa, Texas, and Illinois.