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SI-BONE, Inc. Announces Wellmark Blue Cross Blue Shield Establishes Positive Coverage for MIS SI Joint Fusion Using iFuse

SANTA CLARA, Calif., Sept. 03, 2019 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacro-pelvic anatomy, today announced that Wellmark Blue Cross Blue Shield (BCBS) has established positive coverage for MIS SI joint fusion, providing access to the iFuse Implant System for its 1.5 million members in South Dakota and Iowa. The policy became effective July 1, 2019. In addition, effective September 1, 2019 Health New England has updated its MIS SI joint fusion medical policy to cover only the iFuse Implant System, when performed by a surgeon, for its approximately 200,000 members in Massachusetts.

“We are encouraged to see a significant number of U.S. health plans now recognize the benefits of MIS SI joint fusion, as demonstrated by the more than 75 peer-reviewed publications specific to iFuse, and establish positive coverage policies,” said Jeffrey Dunn, President, Chief Executive Officer, and Chairman at SI-BONE. “We are also pleased that a growing number of payers, such as Health New England, have differentiated the unique characteristics of iFuse, that include its triangular shape and long-term follow-up from 2 RCTs, to establish policies specific to the iFuse Implant System.”

SI-BONE is a medical device company that pioneered the iFuse Implant System, a minimally invasive surgical system for fusion of the sacroiliac joint to treat sacroiliac joint dysfunction. The SI joint is believed to be the last major joint with a clinically proven surgical treatment. The iFuse Implant, commercially available since 2009, is believed to be the only SI joint fusion device supported by multiple prospective clinical studies showing improved pain, patient function and quality of life resulting from treatment. There are over 75 peer-reviewed publications supporting the safety, effectiveness, and biomechanical and economic benefits unique to the iFuse Implant. This body of evidence has enabled multiple government and private 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 immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. 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. ©2019 SI-BONE, Inc. All Rights Reserved. 10506.090319

Media Contact:
Joe Powers, Vice President of Marketing

Investor Contact:
Lynn Lewis or Carrie Mendivil

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One of the most common and unpredictable limitations a company or product will face is the headwinds created by the payor. There are several technologies that lack sufficient clinical data and ultimately get a T-code or non-coverage decision based on it being classified as “experimental”. For some companies, like Paradigm Spine, this can be cripling and ultimately force its acquisition. Time will tell if the acquirer can figure that puzzel out. For others, like SI Bone, a well constructed reimbursement policy has been implemented providing a competitive advantage for the particular product. As an advice to companies with new or potentially disruptive products, don’t underestimate the need to have a proper reimbursement strategy, even prior to your FDA approval. Know what your risks are and do your best to avoid them… especially if your product increases the cost of the overall procedure. Increasing costs greater than $500 without additional reimbursement is almost always a death sentence.

Josh sandberg, president and ceo

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