A Wichita, Kansas diabetes clinic and its Dallas-based owner have agreed to pay the U.S. $775,000 to resolve allegations that he submitted illegal Medicare and TRICARE claims for Trina Health's controversial "artificial pancreas" treatment.
In a press release, the that from September 2015 until May 2017, Trina Health-Wichita NW and owner Jack West sought government payments for the procedure, which prosecutors determined was "not medically reasonable or necessary and specifically not covered by the federal programs," and therefore violated the federal False Claims Act.
The Justice Department statement noted, however, that the settlement included "no determination of liability." Calls to West's cell phone and to his attorney requesting comment were not returned.
The treatment, performed in outpatient settings, was advertised as one that could resolve complications for people with diabetes through pulses of intravenous insulin delivered over 3-4 hours each week.
In 2009, the Centers for Medicare & Medicaid Services reviewed evidence for the procedure (on its own initiative) and determined that it that outpatient pulsed-insulin infusions were clinically beneficial, and denied national coverage.
West, who developed and operated , opened his Trina clinic in Wichita with media publicity, and credited Trina Health founder G. Ford Gilbert for coming up with the concept. West touted the Trina infusion procedure as a remedy for neuropathy and retinopathy, and hoped to build another 20 clinics throughout that state. But Medicare and private insurers eventually stopped paying, and the closed.
Kansas is the second state in which a Trina clinic got into trouble with federal authorities over allegations of fraud. In 2018, a federal grand jury in Alabama indicted Gilbert on seven counts of healthcare fraud and related public corruption charges for trying to bribe a state lawmaker.
In a settlement, Gilbert pleaded guilty to one count of bribery. He was followed by another six months in home detention. He was released from prison this past Friday.
Gilbert still faces a number of other legal actions, including a , former chairman of the department of endocrinology at the University of California Davis, who now runs the Aoki Diabetes Research Institute in Sacramento.
Aoki, who had been working with a pulsed insulin strategy in people with diabetes, claims that Gilbert, with whom he was once associated, took the promising concept and forged ahead with commercializing it before it could be scientifically tested in clinical trials without strict controls on which patients could benefit, and without Aoki's consent. A federal district judge is expected to rule on that case in coming months.
Two years ago, 乌鸦传媒 began an ongoing series on Gilbert's Trina Health enterprises. It chronicled the impact of the so-called artificial pancreas therapy (distinct from closed-loop hybrid infusion systems sometimes called that informally) on patients, and interviewed endocrinologists who were dismayed that patients were choosing these infusions over scientifically based diabetes therapies.
Gilbert said he sold franchises to dozens of investors and medical groups around the country, from Las Vegas to New York and from Miami to San Diego, giving them the right to offer the treatment in free-standing clinics -- often in strip malls or office buildings -- in exchange for several hundred thousand dollars each, plus other fees.
Most if not all of those clinics have now closed, or have rebranded to provide services other than Trina's artificial pancreas.