Healthcare Industry News: HSMN NewsFeed
News Release - May 8, 2017
SI-BONE, Inc. Announces U.S. Military's TRICARE Now Covers MIS SI Joint FusionPositive Coverage Policy Provides 9.4 Million Uniformed Service Members and Their Families Access to the iFuse Implant System®
Includes Access to 55 Military Hospitals and 373 Military Clinics
SAN JOSE, Calif., May 8, 2017 -- (Healthcare Sales & Marketing Network) -- SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® ("iFuse"), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that TRICARE has established a written coverage policy for minimally invasive SI joint fusion surgery. TRICARE is a regionally managed health care program for active duty and retired members of the uniformed services, their families, and their survivors. The policy provides coverage for the 9.4 million members of the United States military's health care system, including access to 55 military hospitals and 373 military clinics, and states that "minimally invasive surgery (CPT® procedure code 27279) for the treatment of sacroiliac joint pain is proven." The positive coverage policy is retroactive to August 23, 2016 and was established based on the high quality prospective clinical evidence published on the iFuse ImplantTM.
"It gives me great pride to announce that the iFuse ProcedureTM is considered a proven treatment by the United States Defense Health Agency and can now be appropriately offered to active and retired military personnel and their family members," said Michael Mydra, SI-BONE's Vice President, Health Outcomes & Reimbursement. "SI-BONE is pleased to be able to help all the brave men and women in our armed forces for their service to our country."
"Earlier this year, we met with Colonel Stephen C. Phillips, DO, MPH and his staff at the Defense Health Agency in Washington, D.C. and reviewed the extensive published clinical evidence for the iFuse Implant. Following that meeting, the TRICARE policy team determined that coverage for MIS sacroiliac joint fusion was appropriate and warranted," said Tony Recupero, Chief Commercial Officer at SI-BONE. "We are now fully engaged with physicians at military facilities across the country to assist them in providing iFuse to appropriately diagnosed military personnel."
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.
SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.
The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse ImplantTM was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer reviewed publications including two level 1 randomized controlled trials.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.
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. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
CPT copyright 2017 America Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved.
1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
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