prodisc® L Lumbar Total Disc Replacement system by Centinel Spine shows a significant expansion to patient access. This represents an additional 9.2 million covered lives and is a result of an update to medical necessity guidelines by National Imaging Associates (NIA), a Magellan Health Company, to now include a positive coverage policy recommendation for lumbar TDR.
NIA Magellan provides third-party prior authorization services to U.S. insurers. Nine major commercial payers that follow NIA Magellan’s clinical coverage guidelines have now started to cover lumbar TDR, including BCBS of Florida & S. Carolina, Harvard Pilgrim and Tufts, among others. Centinel Spine remains the only company in the world with an FDA-approved lumbar TDR device that has been clinically reviewed and found safe and effective for two-level use.
“This recent announcement of expanded coverage for lumbar TDR demonstrates the important progress being made in this area,” stated Centinel Spine CEO Steve Murray. “We are encouraged that NIA Magellan recognizes the large body of clinical evidence that demonstrates lumbar TDR to be a safe and effective procedure for select patients,” continued Murray. “This coverage expansion represents an excellent opportunity for surgeons to provide more patients with a broader spectrum of treatment options and ensure the delivery of the best spine care possible.”
Centinel Spine stands alone as the only company with FDA-approved cervical and lumbar total disc replacement devices. New developments to the family of products include the recent FDA approval of two-level indications for the prodisc L Lumbar Total Disc Replacement system and a recently-initiated clinical trial comparing the prodisc C Vivo and prodisc C SK devices with an approved cervical TDR product as a control, in order to validate their safety and effectiveness in an FDA IDE study.