A 25-bed critical access hospital in a rural Texas town with 4,200 people probably isn't the first place one would expect to find a "cutting edge" infusion that relieves symptoms of metabolic syndrome, rheumatoid arthritis, Parkinson's, gout, macular degeneration, Crohn's disease, and more.
But that is indeed what is being touted by leaders of , 140 miles southwest of Dallas.
"People love it, and they feel better. They have energy. They sleep better. It helps with their inflammatory state. It's crazy what it does for psoriasis to neuropathy, kidney failure," hospital chief of staff Dwayne Miller, MD, told those gathered for a town hall on May 22.
"We've had people with trigeminal neuralgia -- this terrible pain in the jaw. They've gotten better. People with MS and other inflammatory states. It's great in Parkinson's and it's unbelievable how it helps people. So we don't deny anybody help with this."
It's kept at least four of Miller's patients off dialysis, he said during the town hall, a video of which was posted on YouTube but subsequently taken down. "It's crazy what it does for five major cancers."
"This needs to be in every hospital in the United States."
Comanche CEO Larry Troxell said that when the hospital launched the infusions 2 years ago, he was one of the first 50 patients to get them, and the only one who didn't have diabetes. "I got improvement in my eyesight," Troxell said. "When you're losing your eyesight, and you think you're gonna be blind, to start getting that rolled back and go the other direction, it really means something."
The intervention Comanche's leaders are raving about -- and have now administered to 215 patients -- is something they call "Physiologic Insulin Resensitization," or PIR. During 3-hour sessions as often as twice weekly, patients receive boluses of IV insulin and saline every 4 to 8 minutes, offset with glucose given as sugar water, pretzels, or a Coke, Troxell said in a phone interview.
And, Troxell said, "we're getting reimbursed" by payors, including Medicare -- about $500 per session -- and have been for 2 years. So far, he continued, "It is profitable." He said many payments are made under Medicare's prospective payment system.
When asked if physicians and other hospitals should offer it too, Troxell said, "they will see a return on investment that they're gonna be happy with."
If the concept of giving patients insulin infusions rings a bell, that's because PIR sounds remarkably like another venture launched several years ago.
In 2018, 番茄社区 and inewsource published a series of stories about "Trina," a branded network of clinics touting similar infusions that aimed to relieve patients from complications of diabetes and other metabolic conditions.
Leading endocrinology experts labeled the Trina business a "scam."
Medicare researched the data on outpatient intravenous insulin therapy, or OIVIT, and in 2009 issued a that there was no evidence of benefit and refused to cover them. When payors discovered Trina was OIVIT, they stopped paying, clinics folded, and Trina's owner went to prison in 2019 for attempting to bribe a state lawmaker.
Now, leaders of of Houston, which distributes special "precision" infusion pumps and licenses PIR under the names , and , insist PIR is nothing like Trina. But numerous endocrinology experts raised similar alarms that PIR, like Trina, has no evidence behind it and may not be helping patients at all.
Concerned residents of Comanche County in Texas brought the issue to 番茄社区's attention out of concerns that the infusion clinic could fall apart just like Trina's clinics, making their hospital's investment worthless and hurting its financial health.
Full Speed Ahead
Comanche's clinic isn't the only place offering PIR.
A Google search finds PIR advertised by several dozen clinics in eight other states, from and to and and Georgia -- in and and at in Ocilla. Web pages say PIR is available in , Florida; ; Greenville, Mauldin, and Spartanburg, ; and Marks, .
"Well Cell's technology enables physicians to individualize insulin infusion so that the medical professional can build upon 70 years of research ... and implement improved physiologic techniques based on current literature and accepted medical practices," Well Cell partner/owner Glenn Massey said in an . "Well Cell is not involved in direct patient treatment."
Well Cell's website and Comanche hospital's PIR marketing materials (, , , , , ) provided by Comanche area residents boast remarkable benefits: 95% elimination or significant improvement in neuropathy, 76% improvement in at least one diabetic complication, 63% reported HbA1c reduction, and 41% reduced need for at least one medication.
At the May 22 Comanche town hall, held in the hospital cafeteria, Well Cell Global co-founder and CEO Scott Hepford was the guest of honor. He described PIR as "absolutely cutting edge for sure," and growing rapidly. "We just crested a little over 290,000 infusions."
Clinics offering PIR are "simply just using insulin as a hormone ... exactly the way your body has used it your entire life. They're just using it optimally in a way that doesn't get the side effects that come with using insulin as a drug," Hepford said.
PIR provides a way to "custom deliver a technique that gives you the ability to take your metabolism back a few generations to where your body is repairing and regenerating tissue as fast as time."
The various clinics worldwide, he said, are improving patients with conditions "from diabetes all the way to things like Parkinson's. The reason why that's possible, why it helps with inflammation and why it helps with psoriasis and just all these things, is because we're literally creating energy in every single cell in the entire human body."
Well Cell's references four papers (, , , ) published in open-access journals that Hepford and Troxell believe validate benefit for patients, although just a handful of patients were described.
Each paper lists between two and six authors who hold or held Well Cell or staff positions or run PIR infusion clinics.
Experts Skeptical
Leading endocrinology researchers and scientists who reviewed Well Cell's literature questioned why they had not seen any rigorous randomized controlled clinical trials testing any of the medical benefits Well Cell or its licensees claim.
David Nathan, MD, director of the Diabetes Center at Massachusetts General Hospital and a world-renowned leader in diabetes research, looked over the papers and brochures describing PIR's medical benefits and called it "advertising. Advertising is different than data, and I've not seen any data to suggest that it's good for anything."
By data, he wants a controlled clinical trial of high quality, where people with a certain condition are subjected to an intervention, the results from which are compared with results in a similar cohort of participants who received conventional therapy, and both are followed for the long term and powered with enough participants so you can see true differences.
"You know, if this were true, it would be in a major medical journal," Nathan said.
"I just find it frankly offensive for people to be selling a treatment that has not been established," he continued. "I also find it offensive that it gets paid for by public dollars. We have limited resources to do the things we know work."
John Buse, MD, director of the University of North Carolina Diabetes Care Center, also weighed in. "I have not been able to find well-conducted controlled randomized clinical trials to substantiate their claims. What I am concerned about is the evidence of efficacy of the process."
"I do hope someone does a proper study one day," he said.
Mrinalini Kulkarni-Date, MD, chief of endocrinology at Dell Medical School in Austin, Texas, said "we are not very familiar with PIR, and don't advocate its use as a therapy for diabetes."
Decades ago, she was on the faculty of the University of California Davis where endocrinologist Tom Aoki, MD, tested an insulin infusion protocol for people with type 1 diabetes called MAT, or metabolic activation therapy. She said the university discontinued it "as there was insufficient data that supported the use of this therapy."
She added, "my own personal experience with just a handful of patients that I cared for who had received this therapy [MAT] was that they did not have improved HbA1c, or improvement in diabetes complications," she said, although she added they may have been in a subset that failed or stopped the infusions. "The bottom line is that there have been no randomized controlled trials evaluating this therapy in the treatment of type 2 diabetes, and until then, this treatment is difficult to endorse."
Robert Eckel, MD, a past president of medicine and science for the American Diabetes Association and emeritus professor at the University of Colorado Anschutz Medical Campus, said PIR seems "fraught with deception."
"This is a money-making operation and a very concerning practice of medicine," Eckel said. "The unfortunate thing is that there is the placebo effect, where people think they're getting something that they're not."
"I'm not closing the door on the possibility that pulsatile insulin delivery, particularly soon after diagnosis of type 2 diabetes, could have some benefit for residual insulin secretion and diabetes control," he said. "But the burden of proof is on them to show this works in an objective and randomized controlled trial manner."
"This certainly seems to be a way to extract cash from the credulous rather than the medical breakthrough it claims to be," said Steven J. Russell, MD, PhD, associate professor of medicine at Massachusetts General Hospital.
"There is clearly very limited data on this treatment and we are concerned that people with diabetes may be misled to opt for an unproven therapy," said Robert Gabbay, MD, chief scientific and medical officer with the American Diabetes Association and chief medical officer and senior vice president at Joslin Diabetes Center in Boston.
'This Is Not Snake Oil'
In response to 番茄社区's questions, Hepford acknowledged in an that PIR doesn't have clinical trial results yet.
"Such things do not happen quickly," he wrote. But he expects results will be published in 12 to 18 months. He said the four open-access papers "represent fundamental truths of physiology that merit further scientific exploration."
Asked why there was no mention of PIR studies on ClinicalTrials.gov, he said there soon will be.
Comanche hospital, on its own, is trying to gather data on patient outcomes as a research project, and Troxell, who has a degree in health administration from the Medical University of South Carolina, said he has taken on the task himself. He said he's been tracking 90 metrics on its 215 patients, including their diagnoses and whether each patient is realizing their expectations.
Asked who the principal investigator is, he replied, "you're talking to him."
At first, he seemed willing to share his data, but then referred the request to Well Cell.
During the May town hall, Miller acknowledged resistance from outside doctors who don't understand PIR or don't believe it works.
"Trying to educate physicians has been kind of hard. It's been pretty brutal," he said. So he told patients considering the infusions not to ask their doctors about it beforehand.
"If you've got a doctor outside of here, I don't want you to tell your doctor that you're doing this. We've had patients that, they go back and tell their doctor that they're coming to this clinic, and they think we're taking over their healthcare and it's snake oil. This is not snake oil. We've proven that and it's proven around the world," said Miller.
"Unfortunately, the endocrinologists don't know about it, so you're going to hurt his feelings because you're going to know more than he does." Instead, patients should let him or Hepford educate their doctors about PIR, he said.
Miller said that after patients submit their insurance information and undergo an exam to qualify for PIR, he will write to their doctors, send them Well Cell literature, and explain the infusion procedure. "We don't tell them how to practice," Miller said, but he will work with outside physicians to lower doses of medications for issues such as high blood pressure, which, after the infusions, they may not need as much, he said.
Troxell said patients are driving as long as 4 hours one way for the infusions.
"Right now it's going to be difficult to keep up with demand," he said, even as the hospital has expanded to about 30 chairs, with additional clinics in Brownwood, Abilene, and Stephenville.
Trina Redux?
番茄社区's previous series on Trina told how a now-disbarred Sacramento lawyer G. Ford Gilbert, who endocrinologist Aoki had hired for legal help, broke off and began offering insulin infusions he marketed as "Trina" or "artificial pancreas." He sold pumps and protocols to several dozen investors, including a hospital, for $300,000 or more. Gilbert promised that insurance reimbursements would more than make them whole.
And they did, at first.
As time passed, audits prompted payors to realize the claims were for OIVIT and they stopped paying. In some cases, they clawed back, leaving investors, including leaders of a critical access hospital in rural Ruleville, Mississippi, devastated and angry.
Gilbert in 2019 on a federal charge of trying to bribe an Alabama lawmaker to require Blue Cross Blue Shield to cover these infusions after the insurer had stopped.
Gilbert insisted repeatedly that his Trina process was different than OIVIT and different than Aoki's MAT. But in May of 2021, A U.S. District Court judge in Sacramento heard arguments in a 10-year-old Aoki had filed against Gilbert claiming patent and copyright infringement and false advertising.
The judge awarded Aoki $8 million, saying Gilbert had gained access to Aoki's technology and infringed on his patents. According to Aoki's attorney, he has not been paid.
番茄社区 recently talked with Billy Marlow, former executive director of rural North Sunflower Medical Center in Ruleville, Mississippi, which had purchased the Trina protocols and pumps years ago but had to close down the clinic after insurance companies and Medicare stopped paying. "Our losses came from paying Gilbert for the territory and the machines, the pumps" they can no longer use.
Marlow said some patients felt the infusions had helped them, but asked if he would do it again, he said no. "It would have to be specifically approved by the U.S. Food and Drug Administration and Medicare," he said. "Otherwise I'm going to stay away from it."
Paying for PIR
If Medicare and insurance companies won't pay for outpatient insulin infusions, how then are clinics getting reimbursed?
番茄社区 obtained claims documents for patients' infusions showing that Medicare and private insurance reimbursed several hundred dollars under CPT codes 99214-25 (established patient office or other outpatient visit, typically 25 minutes), 96365 (infusion into a vein for therapy, prevention, or diagnosis up to 1 hour), and 96366 (infusion into a vein for therapy prevention or diagnosis), for each infusion session. Documents also showed that Medicare supplemental insurance paid patient copays.
There is no mention of PIR or OIVIT on the claims.
Hepford was asked to reference any Centers for Medicare & Medicaid Services (CMS) policy that exempts PIR from Medicare's non-coverage determination.
His leaned on one sentence from page 46 of the 80-page decision: "CMS does not believe that the available data [in 2009] from OIVIT studies have established its clinical benefit" for the purpose of providing reimbursement. That, Hepford said, meant that "no conclusion was reached that the converse was true; i.e., that the evidence established that OIVIT provides no benefit to patients or that it lacked scientific basis," he wrote.
Troxell also was asked how PIR differs from OIVIT. "That is a completely different application," he said. "You're getting into an area now that I'm not comfortable with." He referred questions to Hepford and Massey. "They know how to get down into the nuts and bolts of it."
CMS was shown studies and marketing material describing PIR and was asked whether the OIVIT decision remains active. A spokeswoman with a reference to the 2009 decision.
"Effective Dec. 23, 2009, CMS determined that the evidence is adequate to conclude that OIVIT does not improve health outcomes in Medicare beneficiaries. OIVIT is not reasonable and necessary for any indication under the Medicare statute. Services comprising an OIVIT regimen are nationally non-covered under Medicare when furnished pursuant to an OIVIT regimen," she wrote.
"Individual components of OIVIT may have medical uses in conventional treatment regimens for diabetes and other conditions," she added.
Concerned Citizens of Comanche
Comanche residents contacted 番茄社区 to express their fears about their hospital's financial future if Medicare and private insurance plans change their minds, linking the infusions with the OIVIT decision.
"I am concerned that we have some liability in the future if this goes south," one patient said. "If Medicare comes in and says, 'We want our money back' or Blue Cross comes in or whoever the insurance is for every other patient, then I'm concerned that we have a liability."
Non-profit Comanche County Medical Center had gross receipts of just under in 2021, according to its tax filing.
Said another concerned citizen: "They're so deep into this now that if something were to occur, and then sort of go away, there would be people who would lose their jobs."
Residents who spoke with 番茄社区 declined to be identified for this story saying they feared retaliation. Some have family members who are employed by or get care from the hospital. Others just said they didn't want to appear disloyal.
番茄社区 tried to contact several hospital-affiliated physicians as well as practitioners in non-affiliated medical groups to seek their thoughts on PIR, but none responded. A nurse for one physician said, "he doesn't want to talk about it, but he doesn't think it works."
One licensed provider couldn't get on board with the infusions, but didn't want to hurt the hospital by being publicly critical. To a reporter asking for data, the provider said, "It sounds like you're on the right path."
"They're all scared," said another.
Hepford repeatedly insisted PIR is not Trina. "Trina was a medical business that administered billing, advised clinicians about what they should charge, and otherwise dictated aspects of patient care," he wrote in an . "Well Cell does none of those things. Rather, Well Cell provides clinicians with FDA-cleared medical pumps and cassettes" that are different than what was used for Trina.
In another , he wrote, "Clinicians, not Well Cell, determine what to bill, how much to charge and whether the pumps and cassettes supplied by Well Cell are appropriate for use in connection with the clinician's assessment of the patient's medical needs."
In a company Well Cell emphasized that "its modality and business is nothing like Trina. Any statement made or implying as such is false and damaging."
Hepford is well aware of Trina. A Better Business Bureau from October of 2014 lists Hepford and Hunter Carr of Houston as owners of the West Houston Trina Clinic. TrinaHealth.com's listed a Trina Clinic in the same building as Well Cell's current headquarters.
Hepford's : "It is true that Trina approached my former business partner and me years ago with a business proposition," but after due diligence, they "declined to go through with the transaction." The bureau's filing is incorrect, he said.
Asked what his hospital will do if reimbursements for PIR stop coming, Comanche administrator Troxell replied: "I will be on the first plane to Washington, because I know what we're doing out here."
"I told congressional leaders in 2016 that we needed to reduce chronic conditions, and I got their attention then. ... I'm going to tell them that we're doing it now. So you talk about an advocate on this. They've got one," Troxell continued. "I can't go at this from a position of fear. We are helping our patients and we're going to continue doing that. If there's ever an issue, we'll address it at that time."
Growing the availability of PIR, Troxell said, is "a passion for us. It's a mission that we want to try to help as many people as we can. Because there's a lot of people with chronic conditions that are looking at a hopeless situation. But we are providing hope. We are making a difference here."
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