SAN JOSE, Calif., May 12, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced that the Medicare Administrative Contractor (MAC) Novitas Solutions, Inc. will begin covering MIS SI joint fusion on a case-by-case basis, including use of the iFuse Implant System effective May 8, 2014. Specifically, Novitas has removed the CPT® code 0334T, which is used by physicians to report the iFuse procedure, from their list of "Services That Are Not Reasonable and Necessary." Novitas is one of eight Part A/B MACs in the United States and the second MAC to make this decision, following Palmetto's decision on February 20th, to remove CPT code 0334T from their list of non-covered services. The change by Novitas will enable over 11 million Medicare beneficiaries to have access to the iFuse procedure if it is medically necessary in the following eleven states: Arkansas, Colorado, Delaware, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, Texas, and the District of Columbia. These eleven states and the District of Columbia along with the Palmetto states of North Carolina, South Carolina, Virginia and West Virginia bring the total number of states where Medicare may cover MIS SI joint fusion to fifteen plus D.C. and the total number of Medicare beneficiaries who have access to this procedure to almost 15 million.
"We are delighted to learn that Novitas has joined Palmetto in making MIS SI joint fusion available to Medicare beneficiaries for whom the procedure is medically necessary. This decision by Novitas provides further validation that MIS SI joint fusion is supported by strong clinical evidence and confirms that the procedure is consistent with generally accepted standards of medical practice in the medical community and is safe and effective. We expect significant additional clinical publications over the next 12 months with long term data," said Michael Mydra, Vice President of Health Outcomes and Reimbursement.
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the "SI Joint Fusion System") for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients.1 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of post-lumbar fusion, so-called "failed back surgery," patients.2 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved. 8810.051214
1 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2 DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.
SOURCE SI-BONE, Inc.