WEST CHESTER, PA — Centinel Spine®, LLC, has announced a significant coverage expansion for its prodisc® L total disc replacement (TDR) system. The largest commercial payers in Illinois, Texas, New Mexico, and Oklahoma have adopted Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria. This development deems one- and two-level lumbar TDR medically necessary, extending coverage to over 14 million additional lives.
The prodisc L system from Centinel Spine holds an exclusive position in the U.S. market as the only TDR system approved by the FDA for two-level use in the lumbar spine. As such, the new guidelines are specifically applicable to this product in the mentioned states.
This coverage update, effective since August 2023, continues the trend towards broader coverage for two-level lumbar TDR. In September, Michigan’s largest commercial payer established positive coverage for one- and two-level lumbar TDR, granting access to 5.8 million covered lives. In October, North Carolina’s largest commercial payer, covering 2.8 million lives, followed suit. With the recent expansion in Illinois, Texas, New Mexico, and Oklahoma, it is estimated that over 30% of commercially-covered lives in the U.S. now have access to two-level lumbar TDR. Meanwhile, coverage for one-level lumbar TDR has surged from 50% in 2017 to an estimated 94%.
The adoption of Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria excludes devices without FDA approval for two-level TDR, explicitly referencing Centinel Spine’s prodisc L system. Additional policy guidelines restrict coverage for the L3-L4 lumbar level to devices FDA-approved for that use, once again highlighting the unique position of prodisc L.
Dr. Osama Ahmed, a Neurosurgeon at the Brain and Spine Institute of San Antonio, hailed this development as a “huge advancement in patient care.” He added, “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 echoed these sentiments, stating, “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 avoid adjacent segment disease.”
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