LCD L39475: Sacroiliac Joint Injections and Procedures

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Low back pain (LBP) is highly prevalent in the Medicare population with reports of 50 to 84% of adults experiencing back pain at some point and is the highest cause of disability globally. Approximately 15% to 30% of patients with persistent mechanical LBP below L5 have pain arising from their sacroiliac joints (SIJ). SIJ dysfunction is common after spinal fusion; and reported in up to 40% in some studies. 1 The SIJ is a complex structure; it is a diarthrodial joint with matching articulate surfaces between the sacrum and ilium separated by synovial fluid and surrounded by a fibrous capsule. It is only a true synovial joint in the anterior portion, due to discontinuity of the posterior capsule. It serves as the biomechanical mediator between the spine and the pelvis. The joint is responsible for flexion and extension of the sacrum with counterrotation of the ileum and there is only a small amount of movement. The complexity of the joint is in the small degree of movement of the joint and the functional supporting structures of the joint (mainly the muscles, fascia and ligamentous connections).

The sacroiliac (SI) joint goes through many changes throughout life. In early childhood, the surfaces of the joint are smooth and allow gliding motions in many directions. After puberty, the surface of the ilium becomes rougher and coated with fibrous plaques that will restrict motion significantly. These age-related changes will increase in the third and fourth decade and by the sixth decade motion may become noticeably restricted. By the eighth decade, plaque will form and erosions will be present. 2 The SI joint has variable joint capacity as the SI joint degenerates with age and has varied from 0.5-2.5 ml.

The exact pattern of innervation of the joint is unclear, but the subchondral bone, capsule and surrounding ligaments are innervated by spinal nerves with nociceptor and proprioceptors and therefore can be a source of pain. Pain from the SIJ complex may arise from the posterior extraarticular elements that are innervated by the lateral branches of S1-S3 and L5 dorsal ramus or the anterior complex innervated by spinal nerves, branches of the gluteal and obturator nerves and lumbosacral trunks known as the intra-articular elements. 1 The spectrum of pain and dysfunction from SIJ pain is variable but can be debilitating.

In addition to conservative and surgical modalities, interventional procedures are used for treatment of SIJ pain. This includes SIJ injections and radiofrequency (RFA) ablation of the SIJ joint. Injections typically are intra-articular and contain anesthetic and corticosteroids. Ablation relies on radiofrequency-generated thermal energy to ablate the sensory nerve fibers of the sacroiliac joint, thereby interrupting nociceptive signals.

The treatment of individuals with spinal disorders, including pain, can be complex, and it is recommended that all individuals being considered for interventional spinal procedures undergo a thorough evaluation and be treated following development of a comprehensive care plan.

Covered Indications

A. Sacroiliac joint injections (SIJI) will be considered medically reasonable and necessary when all the following requirements are met:

• Moderate to severe low back pain primarily experienced over the anatomical location of the SI joints between the upper level of the iliac crests and the gluteal fold, AND

• Low back pain duration of at least 3 months, AND

• Low back pain below L5 without radiculopathy, AND

• Clinical findings and/or imaging studies do not suggest any other diagnosed or obvious cause of the lumbosacral pain (such as central spinal stenosis with neurogenic claudication/myelopathy, foraminal stenosis or disc herniation with concordant radicular pain/radiculopathy, infection, tumor, fracture, pseudoarthrosis, or pain related to spinal instrumentation), AND

• At least 3 positive findings with provocative maneuvers: FABER, Gaenslen, Thigh Thrust or Posterior Shear, SI Compression, SI Distraction and Yeoman Tests, 3,4 AND

• Low back pain persists despite a minimum of 4 weeks of conservative therapies. 5

B. Diagnostic Sacroiliac Joint Injections

Diagnostic SIJI is used to determine if the etiology of pain is from the sacroiliac joint complex. 3

Diagnostic SIJI are considered reasonable and necessary for patients who meet ALL the following criteria:

• The patient must meet the above criteria for Covered Indications for SIJI, AND

• The SI joint injections must be performed under CT or fluoroscopy image guidance with contrast, except ultrasound guidance may be considered reasonable and necessary when there is a documented contrast allergy or pregnancy, since the accuracy with ultrasound guidance is inferior to fluoroscopic guidance, 6 AND

• SI joint injections are not performed with other musculoskeletal injections in the lumbosacral spine, AND

• The documentation should show direct causal benefit from the SI joint injection and not from other musculoskeletal injections or treatments, AND

• The diagnostic SIJI provided a minimum of 75% relief of primary (index) pain with the diagnostic SIJI (a positive diagnostic response is defined as ≥75% sustained and constant pain relief for the duration of the local anesthetic and ≥75% sustained and constant pain relief for the duration of the anti-inflammatory steroid) was measured by the SAME pain scale* at baseline. The measurements of pain must be taken pre-injection on the day of the SIJ injection, post-intervention on the day of the injection, and the days following the injection to substantiate and corroborate the pain scores consistent with the pain relief for the duration of the local anesthetic and/or steroid used.

Limitation: No more than 2 diagnostic joint sessions, unilateral or bilateral. To clarify, 2 unilateral sessions, if performed on 1 side at one session and on the opposite side at a different session, would meet the limitation of 2 diagnostic sessions.

C. Therapeutic SIJI:

Therapeutic SIJI will be considered medically reasonable and necessary for patients who meet ALL the following criteria:

• The patient must meet the above criteria of Covered Indications for SIJI, AND

• The diagnostic SIJI provided a minimum of 75% relief of primary (index) pain with the diagnostic SIJI (a positive diagnostic response is defined as ≥75% sustained and constant pain relief for the duration of the local anesthetic and ≥75% sustained and constant pain relief for the duration of the anti-inflammatory steroid) was measured by the SAME pain scale* at baseline. The measurements of pain were taken pre-injection on the day of the diagnostic SIJ injection, post-intervention on the day of the diagnostic injection, and the days following the diagnostic SIJ injection to substantiate and corroborate consistent pain relief for the duration of the local anesthetic and/or steroid used, AND

• Subsequent therapeutic SIJI are considered medically reasonable and necessary when the subsequent SIJI are provided at the same anatomic site as therapeutic SIJI, AND the therapeutic SIJI produced at least consistent 50% pain relief or at least 50% consistent improvement in the ability to perform previously painful movements and activities of daily living (ADLs) for at least 3 months from the proximate therapeutic SIJI procedure and compared to baseline measurements for ADLS and painful movements or pain relief using the same pain scale* AND

• The SI joint injections must be performed under CT or fluoroscopy image guidance with contrast, except ultrasound guidance may be considered reasonable and necessary when there is a documented contrast allergy or pregnancy, since the accuracy with ultrasound guidance is inferior to fluoroscopic guidance, 6

Limitations: No more than 4 therapeutic SIJI sessions, unilateral or bilateral, will be reimbursed per rolling 12 months. To clarify, a therapeutic SIJI session if performed on one side first and then on the opposite side at a different session would qualify as 2 sessions for the limitation of 4 therapeutic SIJ sessions per rolling 12 months.

D. SIJ Denervation (also called Radiofrequency Ablation or RFA) is not considered reasonable and necessary.

*Note: The scales used to measure of pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.

E. Requirements

• The SIJI must be performed under CT or fluoroscopy image guidance with contrast, unless the patient has a documented contrast allergy or pregnancy where ultrasound guidance without contrast may be considered. 6

• The SIJ procedure(s) should be performed in conjunction with conservative treatments. 7

• Patient should be part of an ongoing, and be actively participating in a rehabilitation program, home exercise program or functional restoration program. 8,9

• SIJ primary index pain must be measured prior to the injection at the beginning of the session.

• The post procedure pain level must be measured after the SIJ injection at the conclusion of the session.

• SIJI may be performed unilateral or bilateral if clinically indicated within the same session.

• The documentation must have the radiographic films (i.e. fluoroscopy images) of the procedure in at least 2 views (i.e., the pre and post contrast injection views in the AP and oblique planes) to confirm intraarticular injection of contrast and the treatment agent(s) used.

• When documenting the percentage of pain relief from the primary (index) pain compared to the post-injection pain levels, it is insufficient to report only a percentage of pain relief and/or a nonspecific statement of the duration of pain relief. The documentation should include a specific assessment of the duration of relief being consistent or inconsistent with the agent used for the injection and the specific dates the measurements were obtained using the SAME pain scale* used at baseline.

• When documenting the ability to perform previously painful movements and activities of daily living (ADLs) it is insufficient to provide a vague or nonspecific statement regarding the improvement of previously painful movements and activities of daily living (ADLs). The documentation should include a functional assessment to show clinically meaningful improvement with painful movements and ADLs, if this metric is used to justify the efficacy of the SIJI procedure. Providers should use established and measurable goals and objective scales to assess functionality and ADLs measures.

Limitations

• Injections performed without radiographic image guidance are not considered reasonable and necessary. 6

• A SIJI involves the use of an anesthetic, corticosteroid, and contrast agent and does not include injections of biologics (e.g., platelet rich plasma, stem cells, amniotic fluid, etc.) and/or any other injectates.

• It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks, trigger point injections, etc.) during the same session as SIJs injections and during the post SIJ injection efficacy assessment period.

• Use of Moderate or Deep Sedation, General Anesthesia, and Monitored Anesthesia Care (MAC) is usually unnecessary or rarely indicated for SIJ injections and therefore not considered medically reasonable and necessary. 10 Even in patients with a needle phobia and anxiety, typically oral anxiolytics suffice. 9

• SIJIs to treat non-specific low back pain (LBP), axial spine pain primary above the level of L5, complex regional pain syndrome, widespread diffuse pain, chronic pain syndrome, and pain from neuropathy are considered investigational and therefore are not considered medically reasonable and necessary.

• SIJIs used as part of a series of lumbar spine and musculoskeletal injections to treat nonspecific or chronic low back pain is not considered reasonable and necessary.

• In patients with implanted electrical devices, (i.e., spinal cord stimulation, peripheral nerve stimulation, cardiac devices, etc.) and intrathecal pump delivery devices, providers should follow manufacturer instructions and extra planning as indicated to ensure safety of the procedure.

• Patients with coexisting psychological conditions or depression related illness should be treated and stabilized prior to proceeding with interventional procedures. 11 Multidisciplinary biopsychosocial rehabilitation principles should be provided to these patients.

• It generally would not be considered medically reasonable and necessary for treatment with SIJIs to extend beyond 12 months. Frequent continuation of SIJIs injections over 12 months may trigger a focused medical review. Use beyond twelve month requires the following:

• Pain is severe enough to cause a significant degree of functional disability or vocational disability and providers use established and measurable goals and objective scales to assess functionality and ADLs measures.

• SIJIs provides at least 50% sustained and consistent improvement of pain and/or 50% sustained and consistent objective improvement in function (using same scale as baseline) for at least 3 months.

• Rationale for the continuation of SIJIs including but not limited to patient who are high-risk surgical candidates, the patient does not desire surgery, and/or the recurrence of pain in the same location was sustained and consistently relieved with the SIJIs for at least 3 months.

• The primary care provider should be notified regarding continuation of procedures and prolonged repeat steroid use to allow for systematic care delivery treatment surveillance and multidisciplinary biopsychosocial rehabilitation (MBR).

• A subsequent diagnostic SIJI is not reasonable and necessary when the initial diagnostic block does not produce a positive response of ≥ 75% pain reduction.

• A subsequent therapeutic SIJI is not reasonable and necessary when the proximate SIJI did not provide at least a consistent 50% pain relief or at least a 50% consistent improvement in the ability to perform previously painful movements and activities of daily living (ADLs) for at least 3 months compared to baseline objective measurements for ADLS and painful movements or pain relief using the same pain scale*

Provider Qualifications

The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

Patient safety and quality of care mandate that healthcare professionals who perform SIJ injections/procedures for chronic pain (not surgical anesthesia) are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings. 12

All aspects of care must be within the provider’s medical licensure and scope of practice. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this policy only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging, ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.

Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.

Definitions

Acute Pain – an unpleasant sensory and emotional experience associated with actual or potential tissue damage which is present for up to 6 weeks. 13

Baseline Pain – An initial measurement of the pain which is taken at a specified time point and used for comparison over time to look for changes in the pain levels.

Chronic Pain – The temporal definition of pain persisting at least 12 weeks after the onset of the acute pain.