The Trina Health sign in Dillon, Montana, is shown here on Nov. 30, 2017. (Brandon QUester/inewsource)
By Cheryl Clark | inewsource
Ron Briggs used to call himself a “good cash cow for the medical industry.” That’s because every few weeks, an ambulance would rush across the rugged, cowboy town of Dillon, Montana, sirens blaring, to revive him from a diabetic coma.
[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]Why This Matters – The nation has a limited supply of healthcare dollars to spend on drugs and services, which is why the government and health plans require scientific evidence of patient benefit. This is especially important for the 30.3 million people in the U.S. with diabetes, whose medical costs in 2012 totaled $245 billion.[/perfectpullquote]
He and his wife, Julie, a strong and mothering woman where Ron is concerned, get choked up when they talk about those days, some four years ago. Those days before they found their “miracle” for treating his disease — the same miracle that would be at the heart of a criminal indictment, embroil them in a lawsuit and lead to their financial ruin.
Ron, then 57, had been struggling with Type 1 diabetes since he was 5, and his condition was getting worse, as was his pain and his frustration. As Beaverhead County’s coroner and deputy coroner, and owners of the only funeral home in Dillon, Julie and Ron understood the signs of death and realized they’d soon apply to him.
His complexion was gray. He could barely walk because neuropathy in his feet made him feel like he was stepping on shards of glass. He couldn’t think straight. The prescription insulin he took for his diabetes didn’t seem to keep his blood sugar under control.
His doctor recommended pain medication and antidepressants, and told him to watch his diet. He refused to take those pills. As for his diet, given how much he was on the road for his job, eating healthy meals was, well, impossible in his mind.
Ron and Julie Briggs. Video produced by Megan Wood and Brandon Quester.
So Ron bought a video camera. He staged himself in the back of the mortuary and was practicing goodbye messages to each of his five children when Julie walked in. She was aghast.
“Don’t you dare,” she yelled, throwing the books in her arms to the floor. She wasn’t ready for him to die.
Julie and Ron had been together nearly 20 years, after what Julie described as nasty divorces. He was the love of her life, her soulmate, her partner.
She told Ron to go home. And don’t wait up.
For hours, Julie searched online for the words “diabetes,” “neuropathy” and “pancreas.” She even contacted people in Switzerland and Germany, anywhere she saw treatments for diabetes.
At some point in the middle of the night, she found “Trina.”
Too good to be true
Dillon is a flat, 1.76-square-mile town in southwestern Montana in a county with far more cows than people. It’s nestled in Beaverhead Valley, about 100 miles — as the crow flies — northwest of Yellowstone Park. Tumbleweed stampedes bounce across the landscape on windy days.
Its remoteness is its attraction. The nearest city with more than 30,000 people is Butte, an hour’s drive away, weather permitting.
(Megan Wood/inewsource)” width=”744″ height=”372″> A scenic overview of Dillon, a rural town of about 4,200 people in western Montana’s Beaverhead Valley. Photographed Dec. 1, 2017. (Megan Wood/inewsource)Dillon’s 4,200 residents boast two intersections with stop lights, although years ago a hay truck knocked down another one and no one saw the need to put it back. The town has at least 11 active churches, and it seems everybody knows everybody else.
A downside of life in a remote town can be limited options, and Ron wasn’t happy with his health care. Julie figured there were better remedies to keep her husband alive that Dillon’s tight-knit medical community hadn’t considered.
As she searched online that night, Julie scoured the website for Trina Health and its “Artificial Pancreas Treatment.” She read about a series of insulin infusions said to improve the body’s ability to metabolize carbohydrates, resolving multiple complications from diabetes. The website said Sacramento lawyer G. Ford Gilbert developed the infusion protocol.
Gilbert claimed that 30 years ago the treatments alleviated his daughter Trina’s complications from Type 1 diabetes, saving her life. The daughter said she’s still healthy today because of weekly Trina infusions.
Julie urged her husband to call Trina Health. Now.
Ron said a clinic manager named Danny in Trina’s Sacramento headquarters got on the phone. He called him “Mr. Briggs,” Ron said, and assured him that 100 percent of their patients “claim they feel better.”
It sounded too good to be true.
But it was 2014, and Julie and Ron were desperate. Trina treatments were offered at a clinic in Scottsdale, Arizona, and BlueCross BlueShield of Montana, the mortuary’s health plan, would pay for them.
Julie flew with her husband to Scottsdale.
Trina believers
Getting to the Scottsdale clinic meant a 15-hour trip: a two-hour drive to the Bozeman, Montana, airport, a change of planes to Phoenix, and a rental car to a Scottsdale hotel.
Each of Ron’s Trina treatment sessions lasted four hours and involved an intravenous, pulsed infusion of insulin. Ron sat in a recliner, drinking a glucose beverage at certain intervals and then undergoing tests that measured how he was metabolizing carbohydrates.
It was the fourth trip to Arizona when Ron, who was by then managing the trek alone, decided he couldn’t live without Trina.
“You’re supposed to have some exercise right after the treatment, and I was in the swimming pool at the hotel … bobbing up and down,” he said. “I finally went over to the edge of the pool and I had tears in my eyes.” He said he called Julie on his cellphone and told her he didn’t know how he would manage such long trips each week, but he needed to keep coming back.
“My vision started clearing up. And my head started working better, thinking-wise. And then all of a sudden, I just, as a whole, my energy level went up and I started feeling better.”
Trina “was like a miracle, a godsend,” Julie said.
It seemed like everyone in Dillon noticed: Ron was a new man. And that got Ron and Julie wondering: Why can’t Trina Health come to their town?
Julie put a “Please Help” notice in the local newspaper, the Dillonite, urging readers to call Trina Health in Sacramento. It said, let Trina Health “know that you support us getting a clinic in our community, either for Ron or if you know anyone that could benefit from the treatment.”
As coroners and funeral home owners in a small town, Ron and Julie have a lot of friends. Julie estimated “probably hundreds” of people around Beaverhead County called Trina’s Sacramento office.
As it happened, Gilbert was in an expansion mode. In June 2014, web archives for Trina Health show nine clinics were operating in six states.
Gilbert is an attorney, not a medical doctor. But he told inewsource that people call him “Doctor Gilbert,” because he has a PhD, which his LinkedIn page says is in health sciences. He said he received it from the online Ashley University.
He has been his company’s biggest promoter and salesman.
Gilbert talks nonstop for hours about Trina, barely taking a breath. He gets agitated and even angry at any suggestion that Trina Health isn’t the best thing for people with diabetes since the discovery of insulin in 1921.
The infusion puts “extra energy back into the cells,” Gilbert said, adding that it saves lives for people with diabetes, and any other condition related to “metabolic dysfunction,” including prediabetes.
Gilbert and his Trina Health website make other claims, too. They say the infusions restore kidney function, reduce congestive heart failure and improve heart function.
The procedure relieves gastrointestinal fatigue, increases energy in patients with chronic fatigue or muscle fatigue and reduces hypertension in 90 days, they say. Gilbert said some women undergo Trina infusions to improve their sexuality, and for men the procedure can reverse erectile dysfunction.
G. Ford Gilbert. Video produced by Megan Wood.
All those claims were impressive, Ron and Julie thought.
Ron remembers exactly the moment when Gilbert responded to the Dillon residents’ pleas. He was in Scottsdale and had just finished his treatment when his cellphone rang.
Gilbert told him his Sacramento phones were “ringing off the hook” with eager patients, Ron recalled, and said “I’m going to tell you what. Let’s put a Trina in Dillon.”
To get it set up, Ron and Julie would need to pay Gilbert about $300,000. They knew they would make that happen, whatever it took.
The couple’s determination brought them into a network of investors and clinicians who each paid Gilbert and his company hundreds of thousands of dollars to open Trina Health clinics in 17 cities. If the upfront costs at other clinics were what Julie and Ron paid, Gilbert has collected millions.
It’s an open question what these investors knew before they made their deals with Gilbert. Were they aware of his reputation with leading medical groups or his battles with Medicare and private insurance companies? Did they see the infusion as a medical miracle, or did they primarily see their clinic as an opportunity for profit?
They certainly didn’t imagine that in early 2018, Gilbert would be at the center of a political corruption scandal, accused of bribery and health care fraud.
Snake oil?
Julie and Ron were business people, but they’d never run a medical clinic. They asked for help from leaders at Barrett Hospital, an 18-bed facility a mile from the couple’s house. That’s where emergency room physicians had so often revived Ron from a diabetic coma.
Initially, Ron and Julie said hospital officials seemed interested.
But weeks passed. Nothing happened.
Those administrators had handed over Ron and Julie’s proposal to the hospital’s medical staff, to physicians who would see what the evidence was and whether Trina really could help their patients.
A meeting was held, but it did not go well.
The couple recalled that one of the doctors told them straight out: If Ron Briggs thought this treatment was helping him, “it’s a placebo.” It was all in his head.
Some Dillon doctors had used words like “scam,” “fraud” and “snake oil.” Ron and Julie said one patient told them his doctor said he’d have to find another physician if he went to the Trina clinic.
Ron didn’t buy it. Those medical naysayers were just nervous, he said, afraid that if Trina Health came to town, their patients with diabetes would no longer need their services.
“Less ambulance runs, less need for the doctor, less need for the hospital. Guess what? This will cost that hospital money,” Ron said with disgust. “It breaks my heart that the almighty dollar is more important.”
Physicians Sandra McIntyre and John Madany remembered that time very differently. They said they did their best, studying and talking about Trina Health for weeks, and were respectful to Ron and Julie, even though, as doctors, they couldn’t see how Trina reversed diabetes complications.
“There’s nothing about what they’re describing that makes physiologic sense,” McIntyre said. “At the end of the day, that’s our job. Our job is to make sure that we vet that kind of treatment. That we vet: Does it make sense? Is there data to support this? Could it cause harm? And then, in the context of Medicare dollars, is this money well spent?”
Their conclusion, she said: “This treatment — we don’t see anything to suggest that this is money well spent for anybody.”
McIntyre said, “The consensus among our entire medical group was, let’s not. … And our administrative leadership appropriately said, if the medical providers aren’t interested, we as an organization aren’t interested.”
It’s common for patients to seek out unproven remedies such as hemp oil, and that’s fine as long as they’re willing to pay for it with their own money, Madany said. What made the Trina infusion different is that federal Medicare dollars and private insurance were paying for it.
That attitude infuriated Ron and Julie, and fostered in them a tremendous distrust of doctors associated with Barrett Hospital.
Gilbert and Trina Health’s corporate leaders reassured them the infusion was legitimate, with no complications. Besides, Medicare and private insurance were covering it, they were told, so it must be OK.
The couple decided to go it alone.
Every dime they had
On Jan. 20, 2015, Ron Briggs signed a licensing agreement with Gilbert to operate the only Trina Health Artificial Pancreas Treatment clinic in Montana. The arrangement included training, use of the proprietary procedure, recliners and a few of Gilbert’s Bionica “Microburst” insulin pumps. Ron Briggs called it “kind of like a franchise.”
Trina’s headquarters in Sacramento handled the billing and submitted the claims to Medicare and private insurance companies for an added 5 percent fee, Julie said.
Other expenses, though, such as staff and utilities, were up to Julie and Ron to cover.
She and Ron said they mortgaged their funeral home to buy a building — just down the street from the town’s Pizza Hut — to house the clinic. For months they worked to convert what had been an insurance office to a medical clinic.
They had to get health permits, liability coverage, equipment and training, hire staff, order utilities, arrange hazardous waste pickup, and make the structure suitable for people with disabilities.
“We spent every dime we had,” Ron recalled in November, later pegging the total at more than $750,000.
Although the couple repeatedly insisted they didn’t open the Trina clinic for profit, they were assured Medicare and health plans would reimburse them. Billing statements show Medicare reimbursed varying amounts, some around $400 per treatment. Private insurance paid somewhat more. The money went directly into their bank account.
Just as they opened their doors in the fall of 2015, the couple received word from Medicare and BlueCross BlueShield, Montana’s major insurance carrier, that their clinic was approved as a health care provider. And patients — with diabetes, heart disease and a number of other conditions — started lining up.
Barry Briggs, 63, a Dillon building contractor and no relation to Ron, would be one of their first patients. He helped put up a 35-foot high sign for the town’s new business:
“Trina Health of Montana Welcomes You.”
And it did, for 10 to 15 patients. People came from across Montana, traveling some 200 miles from Great Falls and some 550 miles from Fort Peck Indian Reservation.
Most patients didn’t pay a thing out of pocket, and no one, the couple insisted, ever suffered an adverse reaction.
Ron and Julie Briggs. Video produced by Megan Wood and Brandon Quester.
The work, the stress and the expense were worth it to help so many people, Julie said. Little did she and Ron know that their clinic would not stay open very long.
Reimbursements rejected
Medicare and insurance reimbursements were inconsistent for Ron and Julie’s clinic. There were payment adjustments and reductions. And logjams. Some claims were rejected because of billing “mistakes,” Julie said, and had to be resubmitted. When the money finally came through, it never seemed to cover all of the costs.
“They never have paid like they should have been paying,” Ron Briggs said. “We had to put money into this thing every day since we opened.”
They had no idea running a clinic would be so hard. “We’re just dumb old country bumpkins, to be honest with you,” Ron said.
What Julie and Ron also didn’t know was that reimbursement claims for Trina clinics in at least one other state were being denied.
In Alabama, BlueCross BlueShield had stopped paying for the treatments months before the couple opened their clinic, citing “insufficient medical evidence to show improvement patterns in patients.” Two clinics in Alabama shut down.
A major blow to Ron and Julie came a year ago, roughly 18 months after they opened their clinic. BlueCross BlueShield of Montana, which covered Ron and two other patients, stopped payment for similar reasons. The “cease and desist” letters said Trina must stop submitting claims for “Artificial Pancreas Treatment.”
The insurance company’s special investigations department manager, Therese Anderson, warned clinic staff to tell patients that going forward patients “will be fully responsible for the cost of such treatments.”
Medicare also stopped paying. Last fall, months after the clinic closed, the agency sent former patients in Dillon statements saying that previously paid claims were now being adjusted to zero. Julie said the agency was asking Ron and her to pay back “a scary amount” — more than $100,000 — of the money they were paid.
“We are in debt. Major debt,” Julie said in November, as she started to cry. She said the couple’s obligations had piled up to more than $1 million. They feared they would lose everything and be forced to leave town. The clinic remains closed.
Couple feels ‘duped’
Unbeknownst to Ron and Julie, Medicare officials decided in 2009 that there was insufficient evidence that a broad category of outpatient IV insulin treatments benefited patients, and therefore, they wouldn’t be reimbursed. Insurance companies often follow the agency’s decisions.
Gilbert insists his infusion procedure is entirely different from what Medicare reviewed.
So Trina clinics did not bill a code that health plans will deny. Instead, they billed for as many as 10 separate services. As far as Medicare and insurance companies knew, patients were receiving office visit services, generic infusions and blood glucose tests, for example.
As Gilbert’s network of clinics expanded, Medicare and some insurance companies have denied payment, saying there is little or no evidence it benefits patients. Clinics eventually shut down in Mississippi, California and several other states.
In Alabama, a federal indictment unsealed on April 2 charged Gilbert with attempting to influence lawmakers into changing policy so it would force insurance coverage of the Trina treatment there. Gilbert, a lobbyist and a politician have all pleaded not guilty. They could face prison terms if convicted.
Back in Montana, Ron and Julie battled BlueCross BlueShield and Medicare. Gilbert helped by hiring a lawyer, Erin MacLean, who sued the insurance plan on behalf of Ron Briggs and two other Dillon patients. On March 5, a Montana judge preliminarily ruled against requiring BlueCross BlueShield to pay for Trina infusions. Attorney Mac Smith, who is representing Julie, said the litigation is ongoing.
The couple said they’re not blaming anyone for their troubles. But Ron said, “I feel like I’ve been duped.”
He said he and Julie should have been told that Medicare had ruled against paying for outpatient insulin therapy, and that other clinics like those in Alabama had closed after insurance plans denied reimbursements.
Gilbert responded that he thought the problems in Alabama were unique, but that he said he sent letters about it to the clinics. Julie replied, “No, he did not.”
Quitting Trina
As it turns out, Trina treatments aren’t without their complications, as Ruby Montie, 77, of Dillon can attest.
A slight woman diagnosed a few years ago with Type 1 diabetes, Montie thought the Trina insulin infusions might relieve nighttime burning in her feet. She endured the treatments for three months, even though they wiped her out.
During the sessions, Montie said, “They give you glucose to drink … and it began making me really nauseated. … And then the horrible thing started where I had, it was more than severe diarrhea,” and she became severely dehydrated.
The last time that hit her, Montie said, she was in the infusion chair, making an embarrassing mess.
Ruby Montie. Video produced by Megan Wood and Brandon Quester.
Linda Tedder, 71, who has had two heart attacks related to her Type 2 diabetes, saw the Dillonite newspaper article that said Trina infusions had done Ron Briggs “so much good.” She went to a welcoming event when the clinic opened in 2015 and was impressed with Ford Gilbert.
Tedder said she was told the insulin infusions would reduce her need for medications and help her lose some weight.
So from 6 to 11 a.m., one day a week for more than a year, she sat in a big, comfy recliner in a room with three or four other people getting infusions, talking about “a lot of things going on around town.”
“I think really that’s partly why I kept going … because I got to know more about the town than I ever did,” Tedder said. “As far as the treatments go, I honestly, honestly, cannot say I saw any improvement.”
Heart wrenching
About two miles down the road from the Trina clinic, physicians McIntyre and Madany talked about their frustration every time they heard their patients talk about all the benefits from Trina.
“It’s heart wrenching to me to see my patients hanging on to this. I think to some degree convincing themselves they’re better when there’s really nothing to explain why that would be. … There’s nothing objectively that tells me that their illness is better,” McIntyre said.
She and Madany called it “snake oil.” McIntyre said, “We sent in fraud documentation to Medicare.”
McIntyre said her staff spends hours on the phone with insurance companies trying to get them to cover diabetes basics, like prescription insulin or testing strips. “Somehow, we’ve got patients, many patients signed up and getting what we believe is an ineffective and kind of a scam treatment, and Medicare is writing the checks,” she said.
The idea that Dillon’s doctors don’t like Trina because it would eat into their revenue is laughable, Madany and McIntyre said. Barrett participates in a Medicare payment model that financially rewards the health system and its physicians for keeping patients healthy and out of the hospital. More hospitalizations could result in lower Medicare payments, which means a loss of money, they said.
Sandra McIntyre and John Madany. Video produced by Megan Wood and Brandon Quester.
If patients believe their health is improving with Trina, other reasons may account for that, Madany and McIntyre added.
Dillon has an aggressive diabetes program that has put many patients on more effective drugs and diabetes prevention dietary regimens.
In recent years, many insurance plans have started covering continuous glucose monitoring devices like the Dexcom, which sends alerts designed to prevent blood sugar irregularities that can send patients to the hospital in a diabetic coma.
Case in point: Ron Briggs.
Julie said her husband began such as the Dexcom G4 in late May 2014, just weeks before he started going to Scottsdale to get Trina infusions.
With Dillon’s Trina clinic closed, Julie started administering Ron’s infusions because they still had the insulin and the pumps they bought from Gilbert. She said she was not a medical professional, and with the holidays, the funeral home to run and the litigation, the four-hour sessions tailed off.
Too much to bear
Just before Christmas, Ron’s health began to decline again.
On Friday evening Dec. 22, Ron told Julie he didn’t think he’d make it through the night. She had to get him to a hospital.
But Ron refused to go to nearby Barrett, Julie said, because the fact the hospital hadn’t supported their Trina clinic had left such a bitter taste. “He was afraid, in his word, they would kill him. I had to take him to Sheridan in a blinding snowstorm.”
So she drove 90 minutes to Ruby Valley Hospital. A blood test indicated Ron may be having a heart attack, so he was taken by ambulance to St. James Healthcare’s emergency room in Butte, 57 miles northwest.
At St. James, tests showed two arteries were 98 percent blocked and a third, 85 percent blocked, Julie said. Ron needed bypass surgery, which St. James couldn’t perform.
On Christmas Eve, he was flown in a fixed wing plane to Billings Clinic Hospital, 230 miles east. There, doctors discovered a blood clot in his leg, and his kidneys were failing. Julie was told he wouldn’t survive heart surgery.
On Dec. 27, Ron died. He was 61.
“I have to tell you something,” Julie Briggs said in tears, 12 days after his death.
“I do believe with all of my heart that if this clinic had not closed, if Ron had been able to get his treatments, then we would not be where we are today.”
Julie said Gilbert called to offer condolences. “He said he just wanted to let me know that if there was anything I needed, just to call. You know, the typical thing that everybody says.”
Julie was sworn in as Beaverhead County coroner on Jan. 16, taking her husband’s place. She will try to run the funeral home by herself.
She was resolved to continue her legal fight to reopen the Trina clinic. “That would be Ron’s legacy,” she said.
But on March 29, Gilbert arrived in Dillon and met with Julie, her attorney and at least one patient. Emotionally and physically, it was just too much to bear. Julie now hopes to sell the clinic.
Despite the stress, the lawsuit and their falling out with their doctors and their hospital, Gilbert’s indictment, and her serious financial woes, Julie said last week that it was all worth it. She maintains her belief that Trina kept her husband alive.
“I had three healthy years with my husband because of this treatment that I wouldn’t have had otherwise. I would walk through the gates of hell for that. Wish Dillon could have been open so that he might still be here.”
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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.
