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| Linx Reflux Management System--Courtesy of Torax Medical |
Torax Medical's Linx Reflux Management System to treat gastroesophageal reflux disease will have its own Category 1 Procedural Terminology Code starting in 2017, paving the way for enhanced public and private reimbursement.
Despite gaining the FDA's stringent PMA approval in 2012, Torax CEO Todd Berg has previously said that Linx suffers from denial of coverage rulings claiming its device is experimental, which force healthcare providers trying to use the device to file an appeal to gain coverage. The delays and extra bureaucracy limit the income the device can generate.
It is implanted around the lower end of the esophagus, near its intersection with the stomach, to prevent the lower esophageal sphincter from allowing stomach acid and bile into the esophagus--or reflux, resulting in heartburn. It consists of a small flexible band of interlinked titanium beads with magnetic cores, according to the company website. Swallowing forces briefly break the magnetic bond, causing the device to expand so that food can enter the stomach.
Dr. Robert Ganz, chief of gastroenterology at Abbott Northwestern Hospital in Minneapolis, near Torax's St. Paul, MN headquarters, said in a release that gastroesophageal reflux disease leads to Barrett's esophagus and esophageal cancer, and that condition is not adequately controlled by medication.
He's the author of the new CPT code application. It was granted by the American Medical Association (AMA), which serves as the reimbursement system's gatekeeper.
"The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties," the AMA says on its website.
Category 1 designation means the Linx implantation procedure is performed by many physicians across the U.S., consistent with current medical practice and supported by clinical studies.
In September, Torax released results of a 5-year study which found that the first-line esophageal sphincter augmentation device reduced heartburn and freed many patients from daily proton pump inhibitor medications.
"The AMA's assignment of a specific code for esophageal sphincter augmentation not only validates the clinical need for the Linx device, but it also confirms that the procedure has achieved the necessary level of utilization and clinical evidence to be included in the U.S. healthcare coding system. Support for the new code came from both Gastroenterological and Surgical Specialty Societies, whose members treat patients with GERD and recognize the need for better treatment options. Importantly, this code will provide surgeons who perform anti-reflux procedures a specific means to communicate with payers when performing the Linx procedure," Berg said in a statement.
- read the release
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