This is the second installment in a two-part investigation of Trina Health, a national clinic chain offering a unique and some say unproven treatment for patients with diabetes, whose founder and chief executive is now caught up in a federal prosecution. Click here to read part one.
For years, Trina Health appeared to be a success, with investors clamoring to open their own clinics to serve the vast population of patients desperate for relief of diabetic complications -- relief that Trina founder and CEO G. Ford Gilbert was promising for every patient.
Christopher David Jones was vice president and one of 14 shareholders in a Trina clinic that opened in June 2016 in Booneville, a city of 8,700 people in northern Mississippi. It eventually drew 120 patients per week, said Jones, a certified public accountant. The clinic billed health plans and Medicare. One patient's insurance reimbursed as much as $700 per session, he said.
Jones said he and his fellow investors paid about $450,000 to Trina corporate to open a clinic. He estimated that of that, $180,000 to $240,000 were in "franchise fees," and the rest was for other items such as equipment and chairs.
Although the clinic grossed about $1 million during its operation, Jones said, the investors are now out about $400,000 after a Medicare contractor, AdvanceMed, questioned the clinic's billing claims in March 2017. By June, he said, the clinic was basically shut down.
"They just kept denying, denying, denying because they didn't believe it was medically necessary," Jones said.
Medicare paid for infusions during much of the time the clinic was open. "Yes, Medicare was paying, but Medicare didn't know they were paying," Jones said. Now Medicare could ask for its money back, but he said they haven't yet.
"It was represented to us by Trina corporate that Medicare had approved this procedure," Jones said, adding that he was specifically referring to Gilbert. That, he said, "wasn't entirely accurate."
"I would have never sold any franchises until Medicare approved this, because now you've got several dozen clinics scattered around [with] people who have put millions of dollars into this, and they're just on hold," Jones said.
North Sunflower Medical Center, a 25-bed critical access hospital in Ruleville, a city of 2,800 people in northeastern Mississippi, had a similar experience. The county where it is located is among the 50 poorest in the United States, excluding Puerto Rico, according to the Census Bureau.
Impressed with the Booneville clinic's initial success, North Sunflower opened its Trina clinic in November 2016 after paying Gilbert and Trina Health about $250,000, said the hospital's executive director, Billy Marlow.
Early on, the center was treating about 90 patients, according to board meeting minutes. But a few months later, in February 2017, BlueCross BlueShield of Mississippi stopped some reimbursements. Medicare denied payments in June.
Now, it is $300,000 in the hole, and the clinic is closed, Marlow said.
"Ford has taken a lot of money from a lot of people," Marlow said. "I feel like Ford has misled us."
Joanie Perkins, North Sunflower's chief compliance officer, added: "The piece I didn't realize is that he did not have an approved clinical trial going on for this therapy."
It's particularly sad for the patients who are now turned away, Marlow, Perkins and Jones said, because they say they have seen patients' diabetes complications significantly abate when they received regular infusions.
North Sunflower officials are discussing the possibility of litigation against Trina Health and Gilbert, Marlow said.
2009 Medicare decision trips up Trina
The reason Trina Health clinics are being denied payment for insulin infusions is rooted in a national Medicare decision in December 2009. That's when the Centers for Medicare & Medicaid Services, which evaluates whether a health service has the scientific backing to justify reimbursement, concluded there was insufficient evidence an outpatient intravenous insulin procedure benefits patients.
If a health provider offers "outpatient IV insulin therapy," or OIVIT, it is supposed to use a special G9147 payment code, and Medicare would deny such claims.
Gilbert and Trina clinics have found a way around that policy. In emails and interviews with inewsource, Gilbert repeatedly insisted that Trina infusions are not OIVIT because he has modified and improved the infusion protocol.
Therefore, he argued, Trina clinics don't submit bills for the G9147 code. Instead, they submit separate reimbursement claims for each service performed during an infusion.
In the United States, there is a long history of people receiving experimental treatments before they have passed rigorous scientific testing, but patients usually have to pay for those procedures out of pocket.
As with the Trina insulin infusions, Medicare and insurance companies can write their policies to refuse to pay for treatments for which there is insufficient scientific evidence of effectiveness.
Clinic network expands amid billing controversy
With Gilbert's argument that his Artificial Pancreas Treatment is not outpatient IV insulin therapy, Trina Health clinics do not mention this procedure on reimbursement claims submitted to Medicare and insurance companies. They list only the individual services provided during each session.
In a recent court decision involving a clinic in Dillon, Mont., the judge wrote that the Trina facility submitted bills where the Artificial Pancreas Treatment "was not identified as the actual service, and instead multiple individual fragments of the treatment were coded separately."
MedPage Today/inewsource also obtained benefit statements from several patients who have undergone the Trina procedure. Those documents charged for services such as "refilling and maintenance of portable pump," "infusion into a vein for therapy," and "established patient office or other outpatient visit, typically 25 minutes."
The payment amounts ranged from $400 to $630 per session. They were reimbursed by private insurance plans or Medicare, by a supplemental insurance plan if the patient had one or the patient's co-payment.
Savvy billing coders for Medicare and insurance companies eventually caught on, however, noting patterns of billing that sounded an alarm and triggered investigations.
Gilbert's critics have not muted his enthusiastic expansion. He claims that new clinics are on contract around the nation and the globe. A center opened last year in Pounding Mill, Va., with more on the way in California, New Jersey, and Tennessee, according to Gilbert.
Asked how he will persuade health plans and Medicare that Trina infusions are worthy of financial reimbursement, Gilbert claimed that he has had multiple meetings with officials at the highest levels of the agency.
"They were impressed," he said of a recent meeting, adding that it led to a telephone call with 17 people. As a result, Gilbert said, "they're no longer aggressive" with audits and denials and requests for files.
Officials for Medicare denied repeated requests for comment.
Investors suffer losses
At Trina clinics across the country, investors have absorbed hundreds of thousands of dollars in financial losses as Medicare and private insurers have cut off reimbursement. Many clinics have closed as a result.
Trina Health websites make this claim: "Most insurance carriers are providing coverage, including Medicare."
Experts say that implies the procedure is considered a federally approved standard of care for people with diabetes. It is not. One of the newest clinics, which as of last week had removed "Trina" from its webpage, is Diabetes Relief Center South Bronx in New York. It claims Medicaid also pays for Trina infusions.
Officials for Medicare and private insurance companies did not respond to inquiries about why Trina clinics in some states continue to be reimbursed, while clinics in other states have been denied coverage.
In recent years, private health plans have ordered clinics to stop billing for "artificial pancreas" treatments, and Medicare has issued statements to patients saying their providers have "been asked to repay" the government. At least 13 of Trina's clinics have suspended operations or closed, most in the wake of reimbursement denials, audits or fraud investigations of facilities in Montana, Mississippi, Kansas and Alabama.
BlueCross BlueShield of Kansas has issued a fraud alert and federal regulators working with Medicare are investigating Trina billing practices, according to testimony in a Montana court case. Marie Cocco, a national spokeswoman for the BlueCross BlueShield Association, declined comment.
Additionally, an investor group that paid Gilbert $782,600 to offer the Trina brand in a start-up clinic in Birmingham sued. The group claims Gilbert neglected to disclose that Medicare and insurers had previously denied coverage. It alleges Gilbert understated the potential for litigation involving the Artificial Pancreas Treatment, and overstated the clinical tests and peer reviewed research that he said substantiated the benefits.
Talk of lawsuits, payment denials and unhappy clinic investors makes Gilbert angry.
In discussions with inewsource/MedPage Today, he called his critics "idiots," "drive-by naysayers" and "stupid." He disparaged one critic in particular as "a self-pontificating, self-aggrandizing narcissistic oaf." Anyone who says Trina is a scam, well, that's "bovine scatatorium," he said.
That was before a federal indictment was handed up in Alabama last week. In it, prosecutors described a scheme hatched by Gilbert to force Alabama Blue Cross Blue Shield to cover Trina treatments after the insurer refused. Gilbert allegedly gave money to House Majority Leader Mickey Hammon in exchange for help in moving legislation that would require coverage.
Indicted along with Gilbert were state Rep. Jack D. Williams, chairman of the House Commerce and Small Business Committee, and Marty Connors, a lobbyist who formerly headed the Alabama Republican Party. Prosecutors said both men knew about the payment to Hammon and worked on behalf of the bill, which ultimately failed to pass. Hammon was not indicted because he had already been convicted on corruption charges in an unrelated case.
Following publication of a version of this story on inewsource’s website, Gilbert responded, “I don’t believe that you are being fair…. I believe you have hurt a lot of people whom you’ll never even meet. It isn’t about me, it’s about helping people.â€
He continued, “You should be embarrassed about how lopsided and inaccurate you have been. You still haven’t found a single clinical practitioner who says the treatment doesn’t work.â€
This investigation was conducted by San Diego-based inewsource in partnership with MedPage Today.