Latest Review Date: December 2024

Category: Surgery                                                                  

POLICY:

Minimally invasive fusion/stabilization of the sacroiliac joint using an FDA approved device may be considered medically necessary when ALL of the following criteria are met:

1. Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; AND
2. There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); AND
3. Patients have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program; AND
4. Pain is caudal to the lumbar spine (L5 vertebra), localized over the posterior sacroiliac joint, and consistent with sacroiliac joint pain; AND
5. A thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere; AND
6. There is a positive response to a cluster of 3 provocative tests (e.g., thigh thrust test, compression test, Gaenslen sign, distraction test, Patrick test, posterior provocation test); AND
7. Diagnostic imaging studies include ALL of the following:
   1. Imaging (plain radiographs and computed tomography or magnetic resonance imaging) of the sacroiliac joint excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy of the sacroiliac joint; AND
   2. Imaging of the pelvis (anteroposterior plain radiograph) rules out concomitant hip pathology; AND
   3. Imaging of the lumbar spine (computed tomography or magnetic resonance imaging) is performed to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; AND
   4. Imaging of the sacroiliac joint indicates evidence of injury and/or degeneration; AND
8. There is at least a 75% reduction in pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular sacroiliac joint injection on 2 separate occasions; AND
9. A trial of a therapeutic sacroiliac joint injection (i.e., corticosteroid injection) has been performed on at least once.

Minimally invasive fusion/stabilization of the sacroiliac joint is considered investigational for all other indications.

Sacroiliac joint fusion, performed by an open procedure, may be considered medically necessary when ONE of the following criterion is met:

• as an adjunct to sacrectomy or partial sacrectomy related to tumors involving the sacrum; OR
• as an adjunct to the medical treatment of sacroiliac joint infection (e.g., osteomyelitis; pyogenic sacroiliitis) or sepsis;

OR

• as a treatment for severe traumatic injuries associated with pelvic ring fracture.

Sacroiliac joint fusion performed by an open procedure for any other indication not listed above is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Sacroiliac joint fusion is a surgical procedure which fuses the iliac bone (pelvis) to the spine (sacrum) for stabilization. It is performed for a variety of conditions including trauma, infection, cancer, and spinal instability. Similar to other structures in the spine, it is assumed that the sacroiliac joint may be a source of low back pain. Fusion of the sacroiliac joint was initially described as a treatment option for low back pain in 1925. Given the depth of and anatomic location of the SI joint, significant morbidity was associated with open fusion approach and limited usage of these procedures.

Research into sacroiliac joint pain has been thwarted by any criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, 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 pain descriptions by the patient. Further confounding study of the sacroiliac joint is that multiple structures, such as posterior facet joints and lumbar discs, may refer pain to the area surrounding the sacroiliac joint.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy (refer to policy # 235 Prolotherapy), corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. For indications and coverage criteria related to diagnosis and other treatments of SIJ pain, refer to policy #558 Diagnosis and Treatment of Sacroiliac Joint Pain.

Over the past few decades, techniques utilizing transiliac approaches to fuse the sacroiliac joint have been developed. Minimally invasive technology has been applied to these approaches and has resulted in the development of percutaneous SI joint fusion procedures in recent years. A 2021 review identified 33 different devices that could be implanted using either a lateral transiliac approach (n=21), posterior allograft approach (n=6), posterolateral approach (n=3), or a combination of the approaches (n=3). The iliosacral and posterolateral approaches use up to 3 implants that pass through the ilium, while the posterior approach involves inserting implants directly into the SIJ. Many of the devices are intended to be used with allograft bone. Implants composed entirely of allograft bone are typically inserted through a posterior approach. The authors found no published evidence for 23 of the 33 devices identified. Devices for SIJ fixation/fusion that promote bone ingrowth to fixate the implants include a triangular implant (iFuse Implant System) and cylindrical threaded devices (Rialto, SImmetry, Silex, SambaScrew, SI-LOK). Some devices also have a slot in the middle where autologous or allogeneic bone can be inserted. This added bone is intended to promote fusion of the SIJ.

Some procedures have been referred to as SIJ fusion but may be more appropriately called fixation (this is because there is little to no bridging bone on radiographs). This posterior approach involves inserting implants into the ligamentous recess between the sacrum and ilium and may be called distraction arthrodesis as the implants increase the joint space and create tension on the ligaments, repositioning the joint surfaces. The devices are intended to be used with allograft bone or are composed entirely of allograft bone that are not specifically indicated/approved for SI joint fusion. According to the 2020 International Society for the Advancement of Spine Surgery (ISASS) policy update, the posterior dorsal approach has “fallen out of favor secondary to problems with both allografts (pseudarthrosis secondary to graft fracture or resorption) and cages (migration and subsidence, loss of lumbar lordosis, high pseudarthrosis rates, and the established need for supplemental spinal fixation)”.

KEY POINTS:

The most recent literature review was performed through September 23, 2024. Following is a summary of key references to date.

Summary of Evidence

For individuals who have SIJ pain who receive SIJ fixation/fusion with a transiliac triangular implant, the evidence includes 1 meta-analysis, 1 blinded sham-controlled trial, 2 nonblinded RCTs of minimally invasive fusion, prospective cohorts with more than 85% follow-up, and case series. Relevant outcomes are symptoms, functional outcomes, QOL, medication use, and treatment-related morbidity. The sham-controlled RCT found no significant difference in the primary outcome of pain reduction or in any secondary outcomes through 6 months of follow-up. Both nonblinded RCTs have reported outcomes past 6 months, after which crossover was allowed. Both studies reported significantly greater reductions in visual analog scale pain scores and Oswestry Disability Index scores in SIJ fusion patients than in control groups. The reductions in pain and disability observed in the SIJ fusion group at 6 months were maintained out to 1 year compared with controls who had not crossed over. The RCTs were nonblinded without a placebo or an active control group. Prospective cohorts and case series with sample sizes ranging from 45 to 149 patients and low dropout rates (<15%) also showed reductions in pain and disability out to 5 years. The cohort studies and case series are consistent with the durability of treatment benefit. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. The meta-analysis pooled data from 3 RCTs and found that SIJ fusion with triangular titanium implants resulted in statistically significant improvements in pain, disability, quality of life, and opioid use compared to nonsurgical management for SIJ dysfunction, with similar adverse event rates between groups, though long-term data beyond 12 months was limited to a single trial.

For individuals who have SIJ pain who receive SIJ fusion/fixation with an implant other than a transiliac triangular implant, theevidence includes 4 prospective cohort studies and retrospective case series. Three prospective cohorts were conducted with transiliac screws and the third with a device inserted through a posterior approach. Meta-analyses of the available prospective and retrospective studies indicate improvement in subjective outcomes from before surgery to follow-up, but with a possible difference in outcomes between the more well studied triangular transiliac implant and other implant designs and approaches. No controlled studies were identified.

There is limited clinical evidence evaluating the safety and effectiveness of distraction or posterior (dorsal) SIJ fusion. The majority of the published studies have evaluated SI joint fusion outcomes using a lateral transiliac approach with device placement through the ileum and across the SI joint. Few authors have reported outcomes using a direct dorsal approach, which involves the placement of bone allograft products or devices into the ligamentuous portion of the joint, involving dissection of the muscle and the removal of a portion of the ligaments covering the outer posterior surface of the joint. A qualitative systematic review by the ISASS found evidence on fusion was limited to 1 prospective multicenter study, no comparative studies, and a small number of case series. Due to distinct differences between the transiliac and posterior approaches, data from studies of lateral minimally invasive transiliac SIJ fusion with transfixing devices are likely not generalizable to the posterior (dorsal) MIS SIJ fusion procedures. Minimally invasive posterior (dorsal) SIJ fusion is not recommended.

Practice Guidelines and Position Statements

In response to requests, focused input on SIJ fusion was received from 5 physician specialty societies and 3 academic medical centers while this policy was under review in 2015. A majority of reviewers considered SIJ fusion to be investigational.

American Society of Pain and Neuroscience

In 2021, the American Society of Pain and Neuroscience (ASPN) published practice a guideline on radiofrequency neurotomy. All of the workgroup members utilized radiofrequency neurotomy in clinical practice. A consensus statement, based on Grade II-1 evidence (well-designed, controlled, nonrandomized clinical trial), was that "lateral branch radiofrequency neurotomy may be used for the treatment of posterior sacral ligament and joint pain following positive response to appropriately placed diagnostic blocks."

In 2024, ASPN published guidance on the treatment of sacroiliac disorders.

The following recommendations were provided concerning SIJ injections, minimally invasive sacroiliac joint fixation and sacroiliac radiofrequency ablation:

• Best Practice Statement on Diagnostic Intra-Articular Injection of the SIJ: The patient should experience greater than 50%relief when an appropriately performed local anesthetic only injection is completed that is consistent with duration of the local anesthetic utilized. A second confirmatory local anesthetic injection can be considered, but not mandatory, when using diagnostic injections to determine candidacy for surgical treatment.
• Best Practice Statement on Conservative Care: Appropriate conservative care should be considered and when acceptable attempted prior to interventional or surgical treatment of sacroiliac dysfunction.
• Best Practice Statement on Intra-Articular Corticosteroid Injections for SIJ Pain: Image-guided, intra-articular corticosteroid injections are recommended for persistent SIJ pain that has persisted despite conservative measures for 4weeks. Fluoroscopic and CT guided injections are the preferred imaging modality of choice, although ultrasound guidance can be considered in situations where radiation exposure may be problematic.
• Best Practice Statement on Neuroablative Technique and Approach for SI Pain: RFA of the SIJ should be performed by an established and researched method and repeated no more than at six-month intervals when an improvement of 50% pain relief and functional improvement is seen.
• Best Practice Statement on Surgical Treatment for SIJ Pain: Minimally invasive surgical treatment can be considered when patients have failed 6 months of conservative treatment and the diagnosis has been confirmed via history, physical exam, and greater than 50% pain relief after a diagnostic, image guided, SIJ injection. Currently, there is no comparative evidence to claim superiority of one minimally invasive technique over another. The recommendation is to choose the safest approach with the greatest chance of clinical success. Approach and implants used should have peer reviewed prospective clinical evidence which demonstrate clinical efficacy and safety.
• Best Practice Statements on Minimally Invasive Sacroiliac Fusion: Minimally invasive posterior SI stabilization with allograft is considered medically necessary when the appropriate clinical criteria have been met. (Grade, A; Level, I-B; Level of certainty, High)
  • Including:
    • A failure of conservative measures to at least include physical therapy and injections.
    • Pain persisting a minimum of 6 months that interferes with functional activities as documented by both a pain score of VAS/NRS of 5 or greater and an ODI of 30 or more.
    • Failure of at least one therapeutic sacroiliac joint injection (less than 50% pain relief for three months duration).
    • 4) Predominant pain pattern consistent with sacroiliac joint pathology.
    • 5) Positive response from at least three validated maneuvers for sacroiliac joint dysfunction.
    • 6) Positive Fortin finger test.
    • 7) Diagnostic imaging: either CT or MRI that excludes destructive lesions of the sacroiliac joint.
    • 8) Diagnostic confirmation of the SI joint as the pain generator demonstrated by at least one image-guided(CT or fluoroscopy) intraarticular injection of the SI joint with 50% or greater pain relief for the expected duration of the local anesthetic.
  • Excluding:
    • Infection or fracture (unrelated to implant)
    • Tumor
    • Acute traumatic instability
• Minimally invasive SI fusion with lateral transfixing devices is considered medically necessary when the appropriate clinical criteria have been met (as above) (Grade, A; Level, I-A; Level of certainty, High)
• Minimally invasive SI fusion implants should be used according to FDA labeling (Grade, A; Level, I-A; Level of certainty, High)
• The use of implants composed of human cell and tissue products for sacroiliac fusion is considered medically necessary only if the guidelines set forth by the FDA Regulation of Human Cells and Tissue is followed and should be registered in the FDA Human Cell and Tissue Establishment Registration. (Grade, A; Level, NA; Level of certainty, High)
• ASPN supports the utilization of sacroiliac fusion and stabilization devices with published, peer-reviewed, multi-center, prospective evidence of at least 6 months duration to assess efficacy and safety. (Grade, A; Level, I-A; Level of certainty, High)
• The current evidence is insufficient to determine the medical necessity of emerging techniques for minimally invasive sacroiliac fusion such as posterior-transfixing, and hybrid approaches. (Grade, I; Level, II; Level of certainty, Low)

International Society for the Advancement of Spine Surgery (ISASS)

In 2020, the International Society for the Advancement of Spine Surgery provided guidance on indications for minimally invasive SIJ fusion with placement of lateral transfixing devices.

The Society recommended that "patients who have all of the following criteria may be eligible for lateral MIS SIJF with placement of lateral transfixing devices:

• "Chronic SIJ pain (pain lasting at least 6 months)
• Significant SIJ pain that impacts QOL or significantly limits activities of daily living
• SIJ pain confirmed with at least 3 physical examination maneuvers that stress the SIJ [list provided above] and reproduce the patient’s typical pain
• Confirmation of the SIJ as a pain generator with > 50% acute decrease in pain upon fluoroscopically guided diagnostic intra-articular SIJ block using a small volume (< 2.5 mL) of local anesthetic......
• Failure to respond to nonsurgical treatment consisting of NSAIDs and a reasonable course (4–6 weeks) of PT. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability"

North American Spine Society

The North American Spine Society (NASS) published coverage recommendations for percutaneous sacroiliac joint (SIJ) fusion in 2015. NASS indicated that there was relatively moderate evidence. In the absence of high-level data, NASS policies reflect the multidisciplinary experience and expertise of the committee members in order to present reasonable standard practice indications in the United States. NASS recommended coverage when all of the following criteria are met:

1. “[Patients] have undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program.
2. Patient’s report of typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain.
3. A thorough physical examination demonstrating localized tenderness with palpation over the sacral sulcus (Fortin’s point, i.e., at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g., greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist.
4. Positive response to a cluster of 3 provocative tests (e.g., thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test). Note that the thrust test is not recommended in pregnant patients or those with connective tissue disorders.
5. Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia).
6. Diagnostic imaging studies that include ALL of the following:
   1. Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SI joint that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion.
   2. Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology.
   3. Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain.
   4. Imaging of the SI joint that indicates evidence of injury and/or degeneration.
7. At least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on 2 separate occasions.
8. A trial of at least one therapeutic intra-articular SIJ injection (i.e., corticosteroid injection).”

NASS posted a protocol for a forthcoming systematic review and guideline on SIJ pain, "Diagnosis and Treatment of Adults with Sacroiliac Joint Pain: A Protocol for a Systematic Review and Clinical Guideline by the North American Spine Society" in February, 2023. The review aims to provide evidence-based recommendations to address critical clinical questions surrounding diagnosing and treating adult patients with sacroiliac joint pain. No estimated date of publication was provided.

National Institute for Health and Care Excellence

National Institute for Health and Care Excellence guidance was published in 2017 on minimally invasive SIJ fusion surgery for chronic sacroiliac pain. The recommendations included:

• “Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure…. provided that standard arrangements are in place for clinical governance, consent and audit.
• Patients having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.
• This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain.”

In 2022, NICE published medical technology guidance on using the iFuse implant system for treating chronic sacroiliac joint pain. It provided the following recommendations:

• iFuse implant system is recommended as an option for treating chronic sacroiliac joint pain.
• iFuse should be considered for use in people with a confirmed diagnosis of chronic sacroiliac joint pain (based on clinical assessment and a positive response to a diagnostic injection of local anaesthetic in the sacroiliac joint) and whose pain is inadequately controlled by non-surgical management.

U.S. Preventive Services Task Force Recommendations

Not Applicable.

KEY WORDS:

Sacroiliac Joint Arthrodesis, SInergy, SI sacroiliac joint stabilization for arthrodesis, SI-FIX Sacroiliac Joint Fusion System, IFUSE Implant System, SImmetry Sacroiliac Joint Fusion System and the SI-LOK, Minimally invasive sacroiliac joint fusion, percutaneous sacroiliac joint fusion, Silex, XTANT, SambaScrew, Si Bone, titanium triangular implant, iFuse-3D, FIREBIRD, SIimpact, Siros, Triton SI Joint Fixation System, Rialto, SacroFuse, SIJFuse, Catamaran, CornerLoc, PainTEQ, LinQ, SI Joint Stabilization NADIA, DIANA, PsiF, SIFix System, TransFasten Posterior Sacroiliac Fusion, dorsal sacroiliac fusion, iFuse TORQ, iFuse TORQ TNT, iFuse Bedrock Granite, UNITY, T-FIX, PathLoc, SI-Cure, Integrity-SI, Sacrix, TORPEDO, Liberty SI Lateral, SILO TFX MIS, Camber, BowTie, CATAMARAN, TiLink-P, Invictus, VyLink Spinal Screw, Patriot-SI Posterior, Huvex, SI-DESIS X

APPROVED BY GOVERNING BODIES:

A number of percutaneous or minimally invasive fixation/fusion devices have been cleared for marketing by the FDA through the 510(k) process. Examples of types of commercially available SIJ fusion devices are listed in the table below.

HCT/P: Human Cell and Tissue Product; N/A: not applicable; N: no; Y: yes.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

Previous Coding: 

CPT Codes:

REFERENCES:

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50. Sachs D, Capobianco R. One-year successful outcomes for novel sacroiliac joint arthrodesis system. Ann Surg Innov Res 2012; 6(1):13.
51. Sachs D, Capobianco R, Cher D, et al. One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis. Med Devices (Auckl). 2014; 7:299-304.
52. Sachs D, Kovalsky D, Redmond A, et al. Durable intermediate-to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2016; 9:213-222.
53. Sayed D, Deer TR, Tieppo Francio V, et al. American Society of Pain and Neuroscience Best Practice (ASPN) guideline for the treatment of sacroiliac disorders. J Pain Res. 2024; 17: 1601-1638.
54. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. J Pain Res. 2022; 15: 3729-3832.
55. Schoell K, Buser Z, Jakoi A, et al. Postoperative complications in patients undergoing minimally invasive sacroiliac fusion. Spine J. Nov 2016; 16(11):1324-1332.
56. Smith AG, Capobianco R, Cher D et al. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes. Ann Surg Innov Res. Oct 30 2013; 7(1):14.
57. Spain K, Holt T. Surgical revision after sacroiliac joint fixation or fusion. Int J Spine Surg. Apr 2017; 11:5.
58. Spiker WR, Lawrence BD, Raich AL et al. Surgical versus injection treatment for injection-confirmed chronic sacroiliac joint pain. Evid Based Spine Care J 2012; 3(4):41-53.
59. Splitt T, Pflugmacher R, Soliman O, et al. Surgical Treatment of Patients with Sacroiliac Joint Syndrome: Comparative Study of Two Implants. Z Orthop Unfall. Nov 22 2023.
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POLICY HISTORY:

Medical Policy Panel February 2014

Medical Policy Group, February 2014

Medical Policy Administration Committee, February 2014

Available for comment March 7 through April 20, 2014

Medical Policy Group, June 2014 (4): Added more References

Medical Policy Panel, May 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Key Points, Key Words, Governing Bodies & References; no change in policy statement

Medical Policy Group, November 2014: 2015 Annual Coding Update – verbiage change to code 27280 to add ‘open’ and ‘including instrumentation when performed’. Also added code 27279 to current coding and created Previous Coding section to include deleted code 0334T.

Medical Policy Panel, May 2015

Medical Policy Group, September 2015 (2): 2015 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (2): 2015 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, October 2016

Medical Policy Group, October 2016 (7): 2016 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, December 2017

Medical Policy Group, January 2018 (7): 2018 Updates to Key Points, Key Words, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, January 2019 (7): Updated Policy Statement- coverage statement added for minimally invasive fusion/stabilization of the sacroiliac joint. Added Keywords: Si Bone, titanium triangular implant. Updated References. Removed Previous Coding section- 0334T was deleted effective 1/1/15. Available for comment February 1, 2019 through March 17, 2019.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (7): Updates to Key Points and References; no change to policy statement.                                                                                                                                           

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (7): Updates to Key Points and References; no change to policy statement. Added Key Words: iFuse-3D, FIREBIRD, SIimpact.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (7): Updates to Key Points, Approved by Governing Bodies, and References. Removed “not medically necessary” verbiage from Policy Statement. No change in intent.

Medical Policy Group, March 2022 (7): Updates to Description, Key Points, and References. No change in Policy Statement.

Medical Policy Panel, November 2022

Medical Policy Group, December 2022: Minor update to Key Points. Removed previous policy statement prior to March 2019. No change in Policy Statement. Keywords added: “Siros, Triton SI Joint Fixation System, Rialto, SacroFuse, SIJFuse, Catamaran, CornerLoc, PainTEQ, LinQ, SI Joint Stabilization NADIA, DIANA, PsiF, SIFix System, TransFasten Posterior Sacroiliac Fusion, dorsal sacroiliac fusion.” 2023 Annual Coding Update- Added CPT code 0775T to the Current coding section.

Medical Policy Group, May 2023: 2023 Quarterly Coding Update - Added CPT code 0809T to the Current coding section.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (7): Updates to Description, Key Points and References. 2024 Coding Update- Added new codes 27278 to Current Coding. Codes 0775T and 0809T deleted and added to Previous Coding section.

Medical Policy Panel, November 2024

Medical Policy Group, December 2024 (7): Updates to Key Points, Approved by Governing Bodies, and References. Added Key Words- “iFuse TORQ, iFuse TORQ TNT, iFuse Bedrock Granite, UNITY, T-FIX, PathLoc, SI-Cure, Integrity-SI, Sacrix, TORPEDO, Liberty SI Lateral, SILO TFX MIS, Camber, BowTie, CATAMARAN, TiLink-P, Invictus, VyLink Spinal Screw, Patriot-SI Posterior, Huvex, SI-DESIS X.” No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.