Hustling Hope: Doctors debunk diabetes treatment as fraud charges hit clinic executive

Just imagine: A nonsurgical treatment that helps millions of people with complications from diabetes restore vision, repair damaged kidneys, and reverse heart disease and cognitive decline. A treatment that heals wounds in their legs and feet, repairs damage from stroke, and eliminates a common type of diabetic nerve pain called neuropathy.

That’s what lawyer G. Ford Gilbert and his network of Trina Health clinics have been promising with his IV insulin infusions offered through his Sacramento-based company. The Trina CEO calls the procedure “miraculous,” and the first “real change” in treatment for people with Type 1 or Type 2 diabetes since the 1921 discovery of insulin.

Gilbert has not been deterred by the nation’s top experts in diabetes who aggressively debunk his procedure, calling it outright fraud and a scam. Nor has he seemed daunted by Medicare and some private insurance companies, which have refused to pay for outpatient insulin infusion procedures because they lack sufficient evidence of medical benefit.

The American Diabetes Association dissuades patients from seeking Gilbert’s branded Artificial Pancreas Treatment, saying people with diabetes are a particularly vulnerable population.

Despite these obstacles, Gilbert has openly marketed his infusion protocols for years, expanding across 17 states, even as investigations, audits and payment denials have shut down many of his clinics.

Now his Trina Health operation faces a new threat. A federal grand jury in Alabama indicted Gilbert on charges of fraud and bribery in a failed scheme that prosecutors said was intended to get a state law passed to force coverage of Trina infusions. Since the indictment was unsealed on Monday, the clinic in the Bronx has taken the Trina logo off its website and the Las Vegas clinic stopped offering the treatments.

Over the years, Gilbert and his clinics have billed Medicare and private insurers untold millions of dollars using a method that regulators and health plans said was incorrect and played a role in the Alabama criminal charges.

Battles over coverage of new treatments and drugs are not uncommon, but what makes the Trina Health conflict unusual is how its network of clinics has thrived despite disagreements over their worth.

All the while, Gilbert has used his evangelical zeal to persuade investor and clinician groups to buy his protocols and open more than two dozen clinics, from Miami to the Bronx and from Las Vegas to San Diego. Each clinic pays Gilbert about $300,000 or more in start-up costs, depending on the size of the operation.

Video: G. Ford Gilbert, Trina Health

Trina Health also has looked to expand beyond the United States. The company website says there is a clinic in India, and Gilbert said he is in talks to launch others in Indonesia and Thailand. He said four clinics would soon open in the U.S. territory of Puerto Rico, with coverage from Medicaid.

“It’s basically a land rush to open clinics, because people see that we help their very ill diabetic patients,” Gilbert said, insisting virtually every patient who has undergone the infusions has seen a dramatic reversal of diabetes complications.

To his detractors, Gilbert replied: “Not one doctor who has ever treated patients said it doesn’t work.” And, he said, no experts who “came back, after taking the time to look at what we did (said) no, no, no, Ford, you’re missing it. … And I think we’re up to about 800 doctors now.”

Trina’s ‘miraculous’ results questioned

Diabetes specialists, including many who learned their patients were undergoing the infusions, vehemently disagree.

More than a dozen interviewed by inewsource said Trina Health’s “artificial pancreas” procedure lacks scientific evidence. Most said it is no more than a business scam that wastes dollars and resources — through Medicare and private insurance — and at least four hours of patients’ time for each infusion session.

What’s more, some said, Trina’s marketing messages convey false hope and have endangered patients’ health because they discount the fundamental strategy of controlling blood sugar levels. Some patients who have undergone infusions said they suffered side effects such as cramping and diarrhea.

The idea behind the Trina infusions has been around for several decades but without good data showing it works, said Dr. Steven Russell, a bionic pancreas researcher and diabetes expert at Harvard Medical School and Massachusetts General Hospital.

“Trina is banking on the impracticality of proving that their therapy doesn’t work (that would take a very long study to prove) and the availability of a ‘sucker born every minute,’ as P.T. Barnum is famously supposed to have said,” willing to sign up, Russell wrote in an email.

Dr. Daniel Einhorn, a La Jolla endocrinologist who is medical director of the Scripps Whittier Diabetes Institute and past president of the American College of Endocrinology, said Trina’s “claims, hype and advertising (sound) as if it’s a seeming cure.”

If the insulin infusions “really offered” such stunning results, “wouldn’t we all be doing this?”

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.

Many diabetes experts are alarmed by this claim on Trina Health websites: “Most insurance carriers are providing coverage, including Medicare.” That implies the procedure is considered a federally approved standard of care for people with diabetes, which it is not. One of the newest clinics, which as of Friday had removed “Trina” from its webpage, is Diabetes Relief Center South Bronx in New York. It claims Medicaid — a federal health program for low-income Americans — 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.

A clinic in Charlotte, N.C., closed, Gilbert said, because of “a bitter dispute” between two owners. He said the facility’s physician wants to open another clinic there, but “we are not going to do that until we have a resolution of the Medicare issue or the doctor elects to not take Medicare.”

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.

In Alabama, Gilbert faces criminal charges of fraud and bribery in connection with three Trina Health clinics that have closed. Federal prosecutors allege Gilbert tried to pay off legislators to change medical reimbursement policies so health plans would be forced to cover his infusion treatments.

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 also 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 of the Trina procedure.

Neither Gilbert nor his attorney have responded to inewsource inquiries since the indictment in Alabama was unsealed on Monday.

Gilbert fights back

All the talk about lawsuits and payment denials and unhappy clinic investors makes Gilbert angry. He calls his critics “idiots,” “drive-by naysayers” and “stupid.” He disparages one critic in particular as “a self-pontificating, self-aggrandizing narcissistic oaf.” Anyone who says Trina is a scam, he said, well, that’s “bovine scatatorium.”

Video: G. Ford Gilbert, Trina Health

“We restore health to the worst of the worst of the worst. To the people who are literally train wrecks,” he said, describing “train wrecks” as those with dementia, retinopathy, unhealing wounds, painful neuropathy and many other diabetes complications.

Gilbert said the reason doctors who treat people with diabetes don’t recognize the benefits of the Trina procedure is because “there’s a lot of inertia involved in medicine.”

Though branded as an Artificial Pancreas Treatment, a Trina infusion does not replace the pancreas, an aspect of Gilbert’s marketing campaign that he acknowledges is confusing.

Simply put, Gilbert said his procedure involves infusing insulin into a patient’s bloodstream to the liver in bursts, every four to six minutes, to stimulate the liver to release enzymes for proper metabolism. Gilbert said the procedure repairs damaged organs and restores vitality.

Each infusion session lasts about four hours. Patients sit in recliners, where they can watch a movie on their electronic tablet or chat with fellow patients. Some take a nap. Typically, the sessions are weekly for the first 12 weeks to six months, and less frequently afterward.

During the sessions, patients intermittently drink two glucose mixtures resembling two typical meals and undergo breathing tests to measure metabolism.

John McCreary, 69, of Poway, has been getting weekly infusions since last summer, and said he’s seen benefits. “I would say 80 percent of the neuropathy in my hands has disappeared at this point. Before (Trina) it literally felt like I was constantly grabbing on to a barrel cactus.”

The 70-year-old Gilbert said he undergoes infusions, too, and has for years “because I get an energy ability that I do not otherwise have.”

Diabetes expert calls Trina procedure a ‘scam’

One of Trina Health’s outspoken critics is a nationally known diabetes expert who extensively reviewed the Trina procedure with Gilbert.

Dr. John Buse, past president of the board of medicine and science for the American Diabetes Association, looked into the evidence behind the infusions in mid-2016. He did so at the request of a North Carolina businessman who was considering opening a Trina clinic. After spending 10 to 15 hours analyzing about 50 articles Gilbert had sent him, and after an hour-long conference call with Gilbert and his team, Buse concluded:

“The advice that I gave the businessman from North Carolina … is that he probably could make money on it, but to me it’s sort of — it was a scam. It’s just not backed up by medical evidence that he would meet his objective of helping people with diabetes in North Carolina.”

In a lengthy email exchange with Gilbert after his analysis, Buse, who is chief of endocrinology at the University of North Carolina, wrote to him: “I tell you what has me hung up. Your uncontrolled studies and slides suggest that everyone gets better and no adverse events occur. I have treated several thousand patients with diabetes and participated or run several hundred trials and that never happens.”

Video: Dr. John Buse

Buse added, “if there is any controlled data of (clinical) trials of more than 30 people for more than a year that I missed, please point it out to me.”

Gilbert initially denied ever having spoken with Buse, then later challenged the doctor’s credibility, saying Buse had not used the Trina protocol on any patients so he wasn’t qualified to give an opinion.

The science behind pulsed insulin infusions “is not preposterous,” Buse said.

But a patient would have to endure much longer infusions every day, or every other day, to get an effect, Buse said. Plus, he said, the claims Trina Health makes about its procedure involve “improving complications, and there’s just no evidence that that happens.”

Patients could be experiencing placebo effect

Many who specialize in treating people with diabetes, including Buse, note that if patients think Trina is reversing their diabetes complications, they may instead be experiencing a placebo effect that frequently accompanies longer, more intense medical interventions and attention.

If patients do appear to be improving, the experts said, it’s likely due to interventions by other providers, such as new glucose management medications and monitoring devices that have come on the market during the same years that Trina Health has been expanding.

“I do not think there is any reason to cave into the notion that there is some benefit (from Trina) and that people appear to get better,” Buse said.

Gilbert’s pronouncements about Trina do not acknowledge that some patients stop coming for infusions or that some suffer side effects after the procedure.

Three patients who received infusions at the Trina clinic in Dillon, Montana, told inewsource they experienced mild to severe diarrhea after their sessions.

“I decided to bag it because it just wasn’t working for me,” said Leonard Shumski, 75, who drove about 200 miles from his home in Great Falls for three months to get the infusions.

His diarrhea bouts, which he said his doctors attributed to the infusions, made his long drive home even longer.

Another Dillon clinic patient, Linda Tedder, said she didn’t notice any benefit from the infusions, and she also had some diarrhea. For a time, she replaced her cardiac rehabilitation with the Trina procedures until her doctor stepped in.

“Dr. (Sandra) McIntyre would say, ‘Linda, you need to quit Trina because it’s not doing you any good, and you need to go back to rehab.’ So I finally listened to her,” Tedder said.

Video: Linda Tedder, Trina Health patient

Gilbert said each clinic is responsible for checking on patients’ welfare after they leave their clinics. What’s more, for all Trina clinics, he said, all patients’ encounter notes “go through here,” meaning Trina’s Sacramento headquarters.

“That’s how we know we don’t have problems. … We’re watching. I would know if we had any wholesale problem,” Gilbert said.

Rural Mississippi loses Trina

Despite doubts about the benefits of infusion treatments, Trina clinics have continued to open, including in impoverished areas of Mississippi.

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 it hasn’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 of 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.

“It looks to me like 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 infusion method dates back more than 30 years to when Gilbert was an attorney for Dr. Thomas Aoki, then a University of California Davis endocrinologist, who developed his pulsed insulin infusion protocols called Metabolic Activation Therapy, or MAT.

Aoki’s clinic tried the therapy on Gilbert’s then 5-year-old daughter, Trina, whom Gilbert said suffered from life-threatening complications of Type 1 diabetes. Gilbert said the infusions restored her health.

About 15 years ago, Gilbert and Aoki had a serious falling out, with Aoki claiming, in effect, that Gilbert stole his idea and created Trina Health. The disagreement is the subject of a patent and copyright infringement and trade secret infringement lawsuit to be heard this summer.

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.

Video: G. Ford Gilbert, Trina Health

But 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 Montana court decision involving the Dillon clinic, 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.”

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 recently opened in Pounding Mill, Virginia, Gilbert said, with more on the way in La Jolla, Calexico, Mount Laurel, N.J., and one in Tennessee.

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.

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Cheryl Clark is a senior healthcare reporter at inewsource and at MedPage Today. inewsource is an independent, investigative journalism nonprofit in San Diego that is supported by foundations, philanthropists and individual donors.