At the Cuyuna Regional Medical Center in Crosby, a 145-bed hospital on the Iron Range, Dr. Paul Severson and Dr. Howard McCollister are two of only four surgeons in Minnesota implanting Linx, a small device made of wire and tiny magnetic beads to help treat chronic acid reflux disease.
While the procedure is FDA-approved, reversible and gaining doctor converts like Severson and McCollister, the number of patients with Linx remains small. The reason? The product, made by Shoreview-based Torax Medical Inc., has not won reimbursement from insurers like Blue Cross and Blue Shield of Minnesota, which classify it as "investigational."
"We have to fight for each and every single patient," McCollister said.
Linx costs about $5,000, with related expenses increasing the total. That means doctors and patients must appeal the decisions of their insurers who deny coverage, or do without a technology that studies have shown is effective in patients for whom medication doesn't work. More than 23 million Americans have gastroesophageal reflux disease (GERD) and spend billions on medicines to treat it.
Todd Berg, Torax president and CEO, said it's not as if insurance reimbursement would open the patient floodgates. Linx is not for everyone, and the company has been conservative in training surgeons. But he said the blanket denial of a product deemed effective by the FDA is unfair to people whose disease has progressed beyond medication.
"The private insurance side is certainly a limitation, it's a problem for any innovation and for patients to have access," Berg said. "The final authority is not the FDA or the physician. It is the private insurance company. And there is no real process there."
Officials at Blue Cross said the insurer had a committee of physicians evaluate the device, but it still classifies the product as investigational because there is "a lack of evidence demonstrating an impact on improved health outcomes."
But McCollister and Severson said a recent study by the New England Journal of Medicine showed most patients with Linx had their reflux eliminated and no longer needed medication.
GERD is a chronic disease that occurs when stomach acid flows back into the esophagus, which irritates the lining. While most people suffer from occasional heartburn, doctors classify it as GERD if symptoms occur a couple of times a week or interfere with daily life.
For many, lifestyle changes, weight loss or over-the-counter medications can control it. But for those with severe, unrelenting symptoms, surgery is an option. The downsides to surgery are uncomfortable side effects, such as an inability to burp or vomit. It's also expensive, costing $15,000 to $25,000.
"We have tried to reserve that for patients who cannot be treated any other way," McCollister said. "And that leaves a gap. In the middle there are 30 to 40 percent of patients for whom medication just isn't enough and surgery is too much."
That is where Torax, a 60-employee private company in Shoreview, and Linx come in.
Berg, who said Torax has spent $70 million over the past decade developing and winning government approval for Linx, said the device is designed for patients whose GERD is progressing to dangerous levels. For those people, the sphincter that closes the stomach from the esophagus has weakened and is starting to fail. Not only is their esophagus damaged, they may also be at a higher risk for esophageal cancer, McCollister and Severson said.
Linx bolsters the failing sphincter. A small flexible band of linked, magnetic titanium beads encircles where the esophagus meets the stomach. The magnetic attraction between the beads helps keep the opening closed. Swallowing temporarily forces the magnetic bond to break, allowing food and liquid to pass through, but closes again afterward.
"They get this treatment, and it changes their lives," Berg said of Linx's 2,000 patients, half of whom live in the United States. In addition to the Cuyuna Regional Medical Center in Crosby, the Linx procedure is also performed at the Mayo Clinic in Rochester and Abbott Northwestern Hospital in Minneapolis.
Gary Norwood had Linx implanted in June 2013. The 45-year-old had been taking Nexium daily for four or five years. Sometimes it worked. Sometimes it wouldn't. "Then it started getting worse, just about every single day and every time I ate," he said.
Norwood's wife works for McCollister and Severson. When she mentioned her husband's trouble, they suggested he come in. He was the first patient to receive the device at Cuyuna's Minnesota Institute for Minimally Invasive Surgery. He had the surgery on a Friday, was out of the hospital on Sunday and back at work excavating Monday. He wouldn't recommend that. "I was pretty sore," he said.
Now? No reflux. And no medication. "You gotta eat a little slower. You have to eat slightly smaller portions," he said. "If I eat too fast, I feel a little cramping pain because the magnet doesn't release pressure fast enough."
Berg acknowledged that the future of Linx may depend on how the cost of the technology compares to a lifetime of taking pills that may only mask the symptoms but do nothing to stop reflux. Torax is gathering data to show that, over time, Linx could save money. Torax has just bought a database of 80 million GERD patients to better break down the costs of the disease, Berg said.
The idea is to try to identify those patients for whom Linx makes economic sense. In the meantime, patients will continue to appeal insurance denials; many prevail, Berg said, but the process is time-consuming and limiting.
Blue Cross and Blue Shield of Minnesota had shown interest in working with Torax to conditionally approve Linx as part of a broader study. But the company reversed course earlier this year and decided not to participate.
In a letter to Berg, a Blue Cross official said the company was "not willing to create an exception" to its policy of not covering the device for purposes of a study. Blue Cross' position on Linx, the official said, "is consistent with the position of other local health plans."