Cigna Healthcare, one of the largest health insurance companies in the United States, has issued a positive coverage policy for the Barricaid® Bone-Anchored Annular Closure device.
CIGNA Covers Barricaid – to Prevent Re-Herniation
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#barricaid#intrinsictherapeuticsSecondary#cigna
Cigna Healthcare’s expanded coverage policy went into effect on June 15, 2023. This expanded coverage will provide discectomy patients with large annular defects access to the Barricaid device.
Intrinsic Therapeutics, Inc., a Woburn, Massachusetts-based medical device company, submitted the device for U.S. Food and Drug Administration (FDA) Pre-Market Approval. It received FDA Pre-Market Approval in 2019.
Per the 2019 FDA Approval Order Statement, the Barricaid Annular Closure Device is “indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large annular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.”
Intrinsic Therapeutics Founder Greg Lambrecht commented, “Twenty years ago I set out to find a solution to save others from the heartbreak I witnessed with my mother’s failed spinal operations.”
Lambrecht continued, “This new coverage policy will give Cigna members access to the Barricaid technology and help to reduce the burden of reherniation and reoperation for discectomy patients when deemed medically necessary by their surgeon.”
Over ten thousand patients have already received the Barricaid implant. Per the company’s press release, Barricaid is “supported by clinical studies in 8 distinct patient populations, including two randomized controlled trials and six single armed trials.”
In the press release, Betsy Grunch, M.D., FAANS, FACS, a board-certified neurosurgeon at The Longstreet Clinic in Gainesville, Georgia, commented in part, “I applaud Cigna’s rigorous clinical review and their decision to issue this positive policy.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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