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Decision follows a final Local Coverage Determination for basivertebral nerve ablation that expanded access to more than 5M covered lives.
June 21, 2023
By: Michael Barbella
Cigna Healthcare has established national coverage for Relievant Medsystems’ Intracept Procedure. The coverage took effect June 15, and expands access to the procedure, when clinically appropriate, for patients in all 50 states as well as Washington, D.C., and Puerto Rico. “This positive coverage determination from Cigna Healthcare, one of the country’s leading health benefit providers, is vastly impactful in increasing patient and physician access to our treatment for vertebrogenic pain,” Relievant Medsystems President/CEO Tyler Binney said. “We look forward to further educating payers on the clinical benefits of the Intracept Procedure in providing significant and durable pain relief, as well as reducing overall healthcare utilization.” The decision from Cigna Healthcare follows Palmetto GBA’s publication in March of a final Local Coverage Determination (LCD) for basivertebral nerve (BVN) ablation that expanded access to more than 5 million covered lives. Palmetto GBA is a Medicare Administrative Contractor (MAC) covering Medicare patients in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia, “The evidence supporting the Intracept Procedure is clear, from the vast portfolio of published clinical evidence to the life-changing outcomes I have witnessed in my practice,” said Brian Durkin, D.O., division chief, New York Spine and Pain Specialists. “As awareness of vertebrogenic pain continues to grow, expanding insurance coverage is essential to help the millions of patients with this distinct condition achieve meaningful relief.” Of the 30 million U.S. residents with chronic low back pain, one in six are likely to have vertebrogenic pain, a distinct type of chronic low back pain caused by damage to vertebral endplates, the interface between the disc and the vertebral body. Patients typically have pain in the middle of their low back, which worsens when they bend over, sit for long periods of time, or when they are active. A physician can confirm a patient’s pain is vertebrogenic by observing Modic changes, a biomarker seen on standard MRI that indicates inflammation at the vertebral endplate. More than 10,000 patients have now been treated with Relievant Medsystems’ minimally invasive Intracept Procedure, the only U.S. Food and Drug Administration-cleared treatment for chronic vertebrogenic low back pain. The same-day outpatient procedure uses targeted radiofrequency energy to stop the BVN from transmitting pain signals to the brain and takes approximately one hour to perform. Based on existing data, patients typically experience minimal post-procedure discomfort and a quick recovery. The Intracept Procedure is supported by strong scientific evidence, including two Level I randomized clinical trials and data showing improvements are sustained more than five years post-procedure. Relievant Medsystems is a commercial-stage medical device company developing ways to diagnose and treat vertebrogenic pain, a form of chronic low back pain (CLBP), with the Intracept Procedure—a clinically proven and commercially available treatment designed to relieve lower back discomfort.
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