Earlier this month, ľֱ and San Diego-based partner inewsource reported on Trina Health, a chain of diabetes care clinics providing a controversial regimen of insulin infusions. That investigation focused on Trina's origins and marketing claims and on founder G. Ford Gilbert's business and legal troubles. Here we finish a two-part follow-up, the tragic story of a Montana couple who believed those claims and opened their own Trina clinic. Part 1 appeared Thursday.
On Jan. 20, 2015, Ron Briggs, the coroner of tiny Beaverhead County, Montana, signed a licensing agreement to operate the only Trina Health Artificial Pancreas Treatment clinic in the state. The arrangement included training, use of the proprietary procedure, recliners and a few of Gilbert's Bionica "Microburst" insulin pumps. Ron called it "kind of like a franchise."
Trina's headquarters in Sacramento, run by lawyer G. Ford Gilbert, handled the billing, submitting claims to Medicare and private insurance companies for an added 5% fee, said Julie Briggs, Ron's co-owner and wife.
Other expenses, such as staff and utilities, were up to the couple to cover.
Julie and Ron said they mortgaged the funeral home they ran 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, 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 weren't intending to run a charity either. They did it having been 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 and -- Montana's major insurance carrier -- that their clinic was approved as a healthcare 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 from as far as 550 miles away, from Great Falls and from the Fort Peck Indian Reservation.
Most patients didn't pay a thing out of pocket. No one, the couple insisted, ever suffered an adverse reaction.
The work, the stress and the expense were worth it to help so many people, Julie said. They had no idea that their clinic would not stay open long.
Reimbursements rejected
Medicare and insurance reimbursements became inconsistent. There were payment adjustments and reductions. There were 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 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.
No physician in Dillon would agree to be medical director, an oversight position they had to have, so they contracted with a family doctor 40 miles away in Sheridan to fill that role.
"That's part of the reason they approached me, because I was outside that [Barrett] hospital care system," said Roman Hendrickson, MD. He said he was rarely at the Dillon clinic.
The Briggses had initially approached Barrett Hospital in Dillon to work with them. But after looking into Trina's claims for the therapy, physicians and administrators there declined all involvement, telling ľֱ/inewsource that they didn't believe the Trina protocol could work.
Julie and Ron didn't know that reimbursement claims for Trina clinics in at least one other state were being denied, for essentially the same reasons cited by Barrett.
In Alabama, BlueCross BlueShield had for the treatments months before the couple opened their clinic, "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" said Trina must stop submitting claims for "Artificial Pancreas Treatment."
The insurance company's special investigations department manager, Therese Anderson, 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, verging on tears. 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.
"Duped"
Unbeknownst to Ron and Julie, Medicare officials back in 2009 that there was insufficient evidence that a broad category of outpatient IV insulin treatments benefited patients. 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 under codes health plans would deny. Instead, they billed for as many as 10 separate services. As far as Medicare and insurance companies knew, patients were receiving services such as office visits, generic infusions and blood glucose tests.
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 Gilbert with attempting to influence lawmakers to force insurance coverage of the Trina treatment. Gilbert, along with a lobbyist and a state legislator also charged, 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 the insurance plan on behalf of Ron and two other Dillon patients. On March 5, a Montana judge preliminarily 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 said he believed the problems in Alabama were unique, but that he said he sent letters about it to the clinics.
Quitting Trina
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."
The last time that hit her, Montie said, she was in the infusion chair, making an embarrassing mess.
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 "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 medication 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."
Linda Tedder sorts through medical bills she received as a former patient of Trina Health. Photographed on Dec. 2, 2017. (Photo credit: Megan Wood/inewsource)
"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
At Barrett Hospital, physicians Sandra McIntyre, MD, and John Madany, MD, 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."
"We sent in fraud documentation to Medicare," McIntyre said.
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 that, under Medicare, 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.
If patients believe their health is improving with Trina, other reasons may account for that, Madany and McIntyre added.
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 and the litigation, the four-hour sessions tailed off.
Too much to bear
Just before Christmas last year, 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. 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. He was taken by ambulance to s emergency room in Butte, 57 miles northwest.
At St. James, tests showed two arteries were 98% blocked and a third, 85% 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 , 230 miles east. There, doctors discovered a blood clot in his leg. 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, the falling out with the local doctors and hospital, Gilbert's indictment, and her serious financial woes -- despite all that, Julie said last week that it was 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."