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SI-BONE, Inc. Announces Centene Establishes Positive Coverage for MIS SI Joint Fusion including the Triangular iFuse Implant System
Источник: Nasdaq GlobeNewswire / 14 июл 2021 07:00:00 America/New_York
SANTA CLARA, Calif., July 14, 2021 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that Centene Corporation has established a positive coverage policy for minimally invasive SI joint fusion.
The new Centene policy considers minimally invasive sacroiliac joint fusion medically necessary for the treatment of low back and buttock pain when certain criteria are met. This decision was based upon the extensive amount of published clinical evidence and reviews demonstrating the safety and effectiveness of the iFuse Implant System.
Centene is a major intermediary for both government-sponsored and privately insured health care programs. It is focused on managed care for uninsured, underinsured, and low-income individuals. Centene has over 25 million members in the United States. The new policy, available at this link, https://ambetter.pshpgeorgia.com/content/dam/centene/policies/clinical-policies/CP.MP.126.pdf, is effective as of July 2021.
“This decision by Centene is an important step in providing greater access to the iFuse procedure for millions of eligible patients,” said Jeffrey Zigler, Vice President of Market Access and Reimbursement at SI-BONE. “We applaud organizations like Centene for continuing to evaluate the evidence for iFuse procedures, updating their policymaking and reaching decisions that improve patients’ access.”
About SI-BONE, Inc.
SI-BONE is a medical device company that pioneered minimally invasive surgery of the SI joint with the iFuse Implant System®. Studies have shown that the SI joint can be a source of pain in 15% to 30% of chronic low back pain. The iFuse implant, commercially available since 2009, is the only SI joint fusion device supported by multiple prospective clinical studies, including two randomized controlled trials, showing improved pain, patient function and quality of life resulting from treatment. There are over 95 peer-reviewed publications demonstrating the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse implant (www.si-bone.com/results). This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment stabilization and immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. In addition, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2021 SI-BONE, Inc. All Rights Reserved.
Investor Contact:
Matt Bacso, CFA
investors@SI-BONE.comMedia Contact:
Joe Powers
jpowers@si-bone.com