Centinel Spine®, LLC, a prominent global medical device company specializing in cervical and lumbar spinal disease solutions through its proven total disc replacement (TDR) technology platform, prodisc®, has announced the integration of Carleon's Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria. This adoption has been embraced by major payers in Illinois, Texas, New Mexico, and Oklahoma, collectively covering a population of over 14 million individuals. Importantly, this endorsement is exclusive to prodisc L, the only lumbar TDR device with FDA approval for two-level use in these specified states.

The positive coverage update, effective since August 2023, signifies a growing trend towards expanded coverage for two-level lumbar TDR. In September, Michigan's primary commercial payer extended coverage to both one and two-level lumbar TDR, benefiting 5.8 million lives. Following suit, in October, North Carolina's largest commercial payer also adopted Carleon's Clinical Appropriateness Guidelines for lumbar TDR, providing access to 2.8 million lives.

With this recent expansion across the four states, it is estimated that over 30% of commercially-covered lives in the U.S. now have access to two-level lumbar TDR. Additionally, coverage for one-level lumbar TDR has increased from 50% in 2017 to an estimated 94% of covered lives today. The adoption of Carleon's guidelines explicitly recognizes Centinel Spine's prodisc L system as the sole FDA-approved TDR system for two-level use in the lumbar spine. Further guidelines specify coverage for the L3-L4 lumbar level exclusively for FDA-approved devices, with prodisc L being the only FDA-approved TDR system for use at the L3-L4 level.

This significant development is seen as a substantial advancement in patient care, particularly with Blue Cross Blue Shield's approval of two-level lumbar disc replacements. The acknowledgment of motion preservation surgery aligns with medical evidence, indicating a shift away from traditional fusions in favor of more readily available and proven alternatives.

Source: prnewswire.com