The largest commercial payers in Illinois, Texas, New Mexico, and Oklahoma have adopted Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria, which deems one- and two-level lumbar total disc replacement (TDR) medically necessary and expands coverage to over 14 million additional covered lives.
The largest commercial payer in North Carolina (2.8 million covered lives) has recently adopted Carleon’s Guidelines, as well—deeming one- and two-level lumbar total disc replacement (TDR) medically necessary.
This update comes on top of the recent announcement that Michigan’s largest commercial payer (5.8 million covered lives) has established positive coverage for one- and two-level lumbar TDR.
Centinel Spine’s prodisc L is the only TDR system in the U.S. approved for two-level use in the lumbar spine.
WEST CHESTER, Pa., November 14, 2023 – Centinel Spine®, LLC, (“the Company”) a leading global medical device company addressing cervical and lumbar spinal disease by providing the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced the adoption of Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria by the largest payers in Illinois, Texas, New Mexico, and Oklahoma—representing over 14 million covered lives. Because prodisc L is the only lumbar TDR device with FDA approval for two-level use, these guidelines only apply to the use of prodisc L lumbar TDR in these states.
This major positive coverage update became effective in August 2023 and continues the trend towards significant coverage for two-level lumbar TDR. In September, the largest commercial payer in Michigan added one and two-level lumbar TDR coverage, providing 5.8 million covered lives with access to lumbar TDR. Then, in October, the largest commercial payer in North Carolina adopted Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria for lumbar TDR, as well—adding 2.8 million covered lives. With this recent coverage expansion in these four states, it is estimated that over 30% of commercially-covered lives in the U.S now have access to two-level lumbar TDR, while coverage for one-level lumbar TDR has grown from 50% in 2017 to a currently estimated 94% of covered lives.
The adoption of Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria specifically excludes devices lacking FDA approval for two-level TDR and explicitly references Centinel Spine’s prodisc L system as being the only TDR system in the U.S. approved for two-level use in the lumbar spine. Additional policy guidelines restrict coverage for the L3-L4 lumbar level to only devices FDA-approved for that use; prodisc L remains the only TDR system in the U.S. approved for use at the L3-L4 level.
According to Osama Ahmed, MD, Neurosurgeon at Brain and Spine Institute of San Antonio, “It’s a huge advancement in patient care that BCBS will now approve two-level lumbar disc replacements. Motion preservation surgery is medically proven and should become more readily available as the paradigm shift away from traditional fusions continues.”
Centinel Spine CEO Steve Murray adds, “The #1 payer in four large states has now provided much needed two-level lumbar TDR access to a significant number of individuals. We look forward to other payers recognizing the clinical benefits of lumbar TDR enabling patients to maintain spinal motion and potentially avoid adjacent segment disease.”
About Centinel Spine, LLC
Centinel Spine®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust total disc replacement (TDR) technology platform in the world (prodisc®). The Company’s prodisc technology is the most studied and clinically-proven TDR system across the globe, validated by over 540 published papers and 250,000 implantations worldwide.
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. The prodisc platform remains the only technology with multiple motion-preserving anatomic solutions allowing the surgeon to Match-the-Disc™ to each patient’s anatomy for both cervical and lumbar total disc replacement.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380