Does not apply to Medicare Advantage
DESCRIPTION
Similar to other structures in the spine, it is assumed that the sacroiliac joint may be a source of low back pain. Sacroiliac joint pain is typically without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for sacroiliac joint pain may include various movement tests, palpation to detect tenderness and description of the pain. Inconsistent information obtained from history and physical exam and the potential for referred pain from posterior facet joints and lumbar discs make sacroiliac joint dysfunction difficult to diagnose.
Proposed treatment options include the use of image-guided anesthetic injection into the sacroiliac joint, radiofrequency ablation (e.g., Sinergy®), and stabilization or minimally invasive arthrodesis (e.g., iFuse Implant System, SI-FIX Sacroiliac Joint Fusion System, Slmmetry Sacroiliac Joint Fusion System, and SI-LOK).
This policy does not address the treatment of sacroiliac joint pain due to infection or neoplasm.
POLICY
Sacroiliac joint injection for the purpose of diagnosing and treating sacroiliac joint pain is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Minimally invasive fusion/stabilization of the sacroiliac joint is considered medically necessary if medical appropriateness criteria are met. (See Medical Appropriateness below.)
Arthrography of the sacroiliac joint is considered investigational.
Radiofrequency denervation of the sacroiliac joint is considered investigational.
Fusion/stabilization of the sacroiliac joint for the treatment of back pain presumed to originate from the sacroiliac joint under all other conditions and with devices other than titanium triangular implants (i.e., iFuse implant system) is considered investigational.
MEDICAL APPROPRIATENESS
Diagnosis and/or treatment of sacroiliac joint pain is considered medically appropriate for ANY ONE of the following:
Injection of anesthetic for the purpose of diagnosing sacroiliac joint pain if ALL of the following criteria are met:
Pain has been unresponsive to a minimum three (3) months of conservative treatment (e.g., oral medications, manipulation, physical therapy)
Dual (controlled) diagnostic blocks with two (2) anesthetic agents with differing duration of action are used
Injections are performed under imaging guidance
Injection of corticosteroid for the purpose of treating sacroiliac joint pain if ALL of the following criteria are met:
Pain has been unresponsive to a minimum three (3) months of conservative treatment (e.g., oral medications, manipulation, physical therapy)
Injection is performed under imaging guidance
Does not exceed three (3) injection sessions within a rolling twelve-month period
Minimally invasive fusion/stabilization using transiliac placement when ALL of the following are met:
Titanium triangular implant is used (i.e. iFuse implant system)
Pain is a minimum of 5 on a 0 to 10 rating scale
Pain impacts quality of life or limits activities of daily living
Pain is caudal to the lumbar spine (L5 vertebra), localized over the poster sacroiliac joint and is consistent with sacroiliac joint pain
Localized tenderness demonstrated with palpation over the sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere
Positive response to a cluster of three (3) provocative tests (e.g., thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test)
Pain has been unresponsive to a minimum six (6) months of intensive nonoperative treatment that includes ALL of the following:
Medication optimization (i.e. prescription strength analgesics)
Activity modification
Bracing
Participation in at least six (6) weeks of physical therapy (i.e., active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint and hip)
Home exercise program
Diagnostic imaging studies include ALL of the following:
Imaging of sacroiliac joint (plain radiographs and CT or MRI)
Imaging of the pelvis (anteroposterior plain radiograph)
Imaging of the lumbar spine (CT or MRI)
Imaging of sacroiliac joint indicates evidence of injury and/or degeneration
Diagnostic confirmation of the sacroiliac joint as a pain generator of at least 75% reduction in pain following fluoroscopically guided intra-articular block using local anesthetic on two separate occasions
A trial of at least one therapeutic sacroiliac joint injection (i.e., corticosteroid injection)
ABSENCE of ALL the following:
Generalized pain behavior (e.g., somatoform disorder)
Generalized pain disorder (e.g., fibromyalgia)
Presence of destructive lesions (e.g., tumor, infection) of sacroiliac joint
Inflammatory arthropathy of the sacroiliac joint
Concomitant hip pathology
Neural compression or other degenerative condition of lumbar spine that could be source of low back pain
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
Does not apply to Medicare Advantage
ADDITIONAL INFORMATION
There is insufficient evidence to determine the effects of arthrography and radiofrequency ablation of the sacroiliac joint on health outcomes. Evidence is insufficient to determine the effects of SI joint fusion/fixation with a cylindrical threaded implant. Controlled trials and longer follow-up are needed to evaluate this type of implant.
SOURCES
American Academy of Pain Medicine / Spine Intervention Society. (2017). Appropriate use criteria for fluoroscopically-guided diagnostic and therapeutic sacroiliac interventions: results from the spine intervention society-convened multispecialty collaborative. Pain Medicine, 18, 2081-2085. Retrieved November 29, 2018 from https://www.ipsismed.org/.
BlueCross BlueShield Association. Evidence Positioning System. (12:2023). Diagnosis and treatment of sacroiliac joint pain (6.01.23). Retrieved January 10, 2024 from https://www.bcbsaoca.com/eps/. (54 articles and/or guidelines reviewed)
Duhon, B.S., Bitan, F., Lockstadt, H., Kovalsky, D., Cher, D., & Hillen, T. (2016). Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up from a prospective multicenter trial. International Journal of Spine Surgery, 10 (13). DOI: 10.14444/3013. (Level 3 evidence)
Heiney, J., Capobianco, R., & Cher, D. (2015). A systematic review of minimally invasive sacroiliac joint fusion utilizing a lateral transarticular technique. International Journal of Spine Surgery, 9 (40), 1-16. (Level 4 evidence)
International Spine for the Advancement of Spine Surgery. (2022). ISASS policy statement - minimally invasive sacroiliac joint fusion. International Journal of Spine Surgery, doi: 10.14444/1025.
Kennedy, D., Engel,A., Kreiner, D., Nampiaparampil, D., Duszynski, B., & MacVicar, J. (2015). Fluoroscopically guided diagnostic and therapeutic intra-articular sacroiliac joint injections: a systematic review. Pain Medicine, 19 (8), 1500-1508. (Level 1 evidence)
Lee, D.W., Pritzlaff, S., Jung, M.J., Ghosh, P., Hagedorn, J.M., Tate, J., & et al. (2021). Latest evidence-based application for radiofrequency neurotomy (LEARN): best practice guidelines from the american society of pain and neuroscience (ASPN). Journal of Pain Research, 14, 2807-2831. (Level 4 evidence)
Leggett, L., Soril, L., Lorenzetti, D., Noseworthy, T., Steadman, R., Tiwana, S., & Clement, F. (2014). Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials. Pain and Research Management, 19 (5), e146-e153. (Level 2 evidence)
Lingutla, K., Pollock, R., & Ahuja, S. (2016). Sacroiliac joint fusion for low back pain: a systematic review and meta-analysis. European Spine Journal, 25 (6), 1924-1931. Abstract retrieved July 5, 2017 from PubMed database.
National Institute for Health and Care Excellence. (2017). Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. Retrieved May 15, 2017 from www.nice.org.uk/guidance/ipg578.
National Institute for Health and Care Excellence. (2022). iFuse for treating chronic sacroiliac joint pain. Retrieved August 30, 2022 from www.nice.org.uk/guidance/mtg39.
Polly, D., Swofford, J., Whang, P., Frank, C., Glaser, J., Limoni, R., et al. (2016). Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction. International Journal of Spine Surgery, 10 (28), 1-22. (Level 2 evidence)
Rappoport, L.H., Luna, I.Y., & Joshua, G. (2017). Minimally invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw: preliminary 1-year clinical and radiographic results of a 2-year prospective study. World Neurosurgery, 101, 493-497. Abstract retrieved December 29, 2017 from PubMed database.
Sachs, D., & Capobianco, R. (2012). One year successful outcomes for novel sacroiliac joint arthrodesis system. Annals of Surgical Innovation and Research, 2012, 6, 13. (Level 4 evidence)
Simopoulos, T., Manchikanti, L., Gupta, S., Aydin, S., Kim, C.H., Solanki, D., et al. (2015). Systematic review of the diagnostic accuracy and therapeutic effectiveness of sacroiliac joint interventions. Pain Physician, 2015 (18), E713-E756. (Level 1 evidence)
Tran, Z.V., Ivashchenko, A., & Brooks, L. (2019). Sacroiliac joint fusion methodology - minimally invasive compared to screw-type surgeries: A systematic review and meta-analysis. Pain Physician, 22 (1), 29-40. (Level 1 evidence)
U. S. Food and Drug Administration. (2008, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K101372 (iFuse™). Retrieved September 2, 2016 from http://www.accessdata.fda.gov.
Vanaclocha, V., Herra, J., Sáiz-Sapena, N., Rivera-Paz, M., & Verdú-Lόpez, F. (2017). Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-year comparative case series. Neurosurgery, doi: 10.1093/neuros/nyx185. [Epub ahead of print]. (Level 4 evidence)
Whang, P.G., Darr, E, Meyer, S.C., Kovalsky, D., Frank, C., Lockstadt, H., et al. (2019). Long-term prospective clinical and radiographic outcomes after minimally invasive lateral transiliac sacroiliac joint fusion using triangular titanium implants. Medical Devices: Evidence and Research, 12, 411-422. (Level 2 evidence)
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, September; last update search August 2023). Minimally invasive sacroiliac joint fusion using triangular titanium implants (iFuse Implant System, SI-Bone Inc.). Retrieved November 17, 2023 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, September; last update search August 2023). Minimally invasive sacroiliac joint fusion using cylindrical threaded implants. Retrieved November 17, 2023 from www.Hayesinc.com/subscribers. (34 articles and/or guidelines reviewed)
Zaidi, H. A., Montoure, A., J., & Dickman, C. A. (2015). Surgical and clinical efficacy of sacroiliac joint fusion: a systematic review of the literature. Journal of Neurosurgical Spine, 23 (1), 59-66. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 8/1/2002
MOST RECENT REVIEW DATE: 1/11/2024
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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