“Artificial Pancreas” Clinic CEO Indicted

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Trina Health founder G. Ford Gilbert has been accused by the federal government of conspiring with Alabama lawmakers to get insurance coverage for his company’s unproven treatment.

-by Craig Idlebrook, Glu community and content manager/GluCraig

The owner of a company that touts a controversial “artificial pancreas” in-clinic treatment has been indicted on charges related to an alleged public corruption scheme, according to a press release by the U.S. Department of Justice.

Ford Gilbert, owner and CEO of Trina Health, has been indicted, along with an Alabama state senator and another Alabama political figure, for what the Justice Department alleges was a corrupt scheme to push for legislation to force Blue Cross and Blue Shield of Alabama to provide insurance coverage for the treatments in the state.

Trina Health runs a series of in-patient clinics that provide what is characterized by insurance officials as “outpatient intravenous insulin therapy” for people with diabetes. This treatment, which goes by many names depending on the company providing treatment, is also called an “artificial pancreas treatment” and a “microburst insulin infusion” in Trina Health promotional literature.

The Justice Department indictment characterizes the treatment in this manner: “This process required the patient to spend three hours in a chair at a Trina Health outpatient clinic. During those three hours, the patient received, through intravenous injection, a series of injections of insulin. The Bionca pump was used to administer these intravenous insulin injections. Trina Health recommended that a patient undergo this artificial pancreas treatment once per week in order for the patient to see beneficial health outcomes.”

Trina Health officials claim the treatment provides an insulin infusion which causes the liver to produce enzymes that process carbohydrates more efficiently. They claim this treatment can prevent or reverse complications from diabetes.

However, federal health regulators have not been convinced there is evidence of the validity of the treatment, and many have refused to cover it. In 2009, The Centers of Medicare and Medicaid Services announced that “evidence does not support a conclusion that outpatient intravenous insulin therapy improves health outcomes in Medicare beneficiaries.” Major insurers have followed suit, with aetna declaring that the treatment was “experimental and investigational for the management of diabetes mellitus and all other indications because its clinical value has not been established.” Blue Cross and Blue Shield of Alabama stated it would not cover the treatment because of lack of “strong clinical and scientific evidence” of its effectiveness, according to a report in Al.com.

When Trina Health-affiliated clinics opened in Alabama in and around 2014, the indictment states that Blue Cross and Blue Shield of Alabama would not reimburse the complete treatment. Instead, the indictment alleges, Trina Health billing employees used deceptive billing codes to successfully bill for the treatment in parts. In 2015, according to the indictment, Blue Cross and Blue Shield of Alabama caught on to this alleged scheme, cut off payment, and demanded reimbursement for the improper billing.

The Department of Justice alleges that Gilbert devised a plan to push a bill through the Alabama legislature to require Blue Cross and Blue Shield of Alabama cover the treatment. He then allegedly “made payments to State of Alabama House Majority Leader Micky Hammon in exchange for his efforts on behalf of the bill.” The Justice Department also alleges that lobbyist Martin J. Connors was retained by Trina and that Connors recruited state representative Jack D. Williams to aide in the bill’s passage; both these men knew of the arrangement between Hammon and Trina’s Gilbert, alleges the Justice Department. (Hammon had already been convicted in federal court on other charges and was not included in this indictment.) Gilbert, along with the two co-defendants, have been charged with conspiracy to commit bribery related to federal programs, conspiracy to commit honest services wire fraud, and honest services wire fraud under the indictment.

As of late evening on April 2, 2018, Trina Health has not released a statement about the indictment on its social media channels. Initial arraignments for the case have been set for April.

You can read the full indictment here:

https://docs.google.com/viewerng/viewer?url=http://WSFA.images.worldnow.com/library/7c5c824d-a3d1-4a29-8734-3dee118a0dc4.pdf

And a press release of the indictment here:

https://www.justice.gov/usao-mdal/pr/alabama-legislator-alabama-lobbyist-and-owner-california-company-charged-public

For more reading on the case, click here:

http://www.al.com/business/index.ssf/2018/04/who_is_ford_gilbert_california.html

http://www.wistv.com/story/37860070/al-representative-lobbyist-healthcare-ceo-arrested-by-fbi-on-bribery-charges

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=231&fromdb=true

http://www.aetna.com/cpb/medical/data/700_799/0742.html

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