Surgeons and Spine Societies Increase Patient Access to Barricaid® for Discectomy Surgery Following Recent Coding Successes and Recognition in Updated Guidelines
WOBURN, Mass., June 2, 2020 /PRNewswire/ -- Intrinsic Therapeutics, Inc., a medical device company focused on delivering safe treatments to improve surgical efficacy, today announced growing enthusiasm among physicians for its Barricaid technology, which manages lumbar disc herniation. While elective surgeries have been put largely on hold throughout the country as a result of the COVID-19 public health emergency, expert surgeons have been working behind the scenes to build on recent coding successes and recognition of the Barricaid procedure in key clinical specialty guidelines. As leading surgeons and spine specialty societies take steps to increasing patient access to the Barricaid technology, Intrinsic is offering virtual and hands-on training sessions to support surgeons as elective surgeries resume across the nation.
Barricaid is the only FDA-approved device that effectively treats large defects in the annulus with implantation of a bone-anchored annular closure device following lumbar discectomy. It is indicated to reduce incidence of reherniation and reoperation. Effective January 1, 2020, the Centers for Medicare & Medicaid Services (CMS) established a new code for the Barricaid device, C9757, which hospital outpatient departments and ambulatory surgical centers can use to report repair of the annular defect following lumbar discectomy and implantation of the Barricaid device. This is a significant step for the technology, since it provides for standard payment through the code's inclusion in Medicare's hospital outpatient and ASC national fee schedules.
Shortly after the CMS coding announcement, the International Journal of Spine Surgery – the official publication of the International Society for the Advancement of Spine Surgery (ISASS) – issued policy guidance that supports both coverage and coding for the Barricaid technology in appropriately selected patient populations.1 Principal author Morgan Lorio, MD, FACS, observed that "Our evidence review determined that the only annular repair technique that is supported by high-level clinical evidence is the Barricaid bone-anchored annular closure used for patients with large annular defects. For these patients, bone-anchored annular closure – with the Barricaid device – improves the probability of avoiding recurrent lumbar disc herniation and sustaining the treatment benefits of discectomy."
The importance of a cost-effective treatment option for patients with large annular defects is underscored by a published Level IA expert review and meta-analysis of four comparative studies (n=801 patients) including two randomized-controlled trials involving more than 600 patients. The analysis determined that at two years, the risk of symptomatic reherniation and reoperation were approximately 50 percent lower in patients who had the Barricaid implanted following lumbar discectomy.2 R. Todd Allen, MD, PhD, Associate Professor of Orthopaedic Surgery at UC San Diego Health System, commented that "This meta-analysis clearly indicates that large annular defects heighten the risk of recurrence and reoperation after lumbar discectomy. This is actionable information, given the evidence supporting use of bone-anchored annular closure for such patients."
With the new CMS coding available and ISASS guidance in hand, and recognizing the clinical importance of annular defect size, spine surgeons have been working to develop ICD-10 diagnosis codes to enable more granular identification of annular defects based on defect size within the lumbar region. Joshua Ammerman, MD, FAANS, FACS, Chair of the Department of Surgery at Sibley Memorial Hospital and Chief of the Neurosurgery Section, a leading researcher and expert on minimally invasive spine surgery, commented, "As evidence mounts about the benefits of bone-anchored annular closure for large annular defects, an ICD-10 diagnosis code application is being submitted. These codes will give providers the tools they need to more precisely report these annular defects on claims. This will enhance our knowledge of patient outcomes, which in turn will help guide patient selection and ultimately lead to better patient care." The ICD-10 coding application, expected to be considered later this year, is supported by ten years of clinical history and more than 50 peer-reviewed published studies (including two randomized controlled trials).
"We appreciate all the progress that is being made on patient access to Barricaid by leading surgeons and spine speciality societies," added Intrinsic Therapeutics CEO and President Cary Hagan. "With more than 20 insurers now covering Barricaid, together with the support of surgeons and specialty societies, and more than 50 peer reviewed manuscripts, we are confident in our ability to continue delivering needed and cost-effective care for lumbar discectomy patients with large annular defects."
Intrinsic continues to respond to surgeons' requests for training sessions by conducting virtual training to be followed by hands-on training and the proctoring of cases as elective surgery resumes. Surgeons can register for training at https://www.barricaid.com/webinar/.
About Intrinsic Therapeutics
Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following a lumbar discectomy surgery. The Barricaid bone-anchored annular closure device received FDA PMA-approval following completion of a 554-patient randomized controlled trial that achieved superiority at two years. Survival analyses have indicated statistical significance in reducing reherniations and reoperations through five years. See http://www.barricaid.com for complete benefit-risk information.
Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.
Ivo Scheepens, Vice President of Marketing
Intrinsic Therapeutics, Inc.
1 Lorio M, Kim C, Araghi A, Inzana J, Yue J International Society for the Advancement of Spine Surgery Policy 2019—Surgical Treatment of Lumbar Disc Herniation with Radiculopathy International Journal of Spine Surgery, Vol. 14, No. 1, 2020, pp. 1–17.
2 Miller LE, Allen RT, Duhon B, Radcliff KE. Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation. Expert Review of Medical Devices, DOI: 10.1080/17434440.2020.1745061
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SOURCE Intrinsic Therapeutics, Inc.