Medical Policy: 07.01.39 

Original Effective Date: January 2008 

Reviewed: July 2021 

Revised: July 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

A variety of minimally invasive techniques have been investigated over the years as a treatment of low back pain related to disc disease. Techniques can be broadly divided into techniques that are designed to remove or ablate disc material and thus decompress the disc or those that are designed to alter the biomechanics of the disc annulus which include automated percutaneous lumbar discectomy, laser discectomy, percutaneous laminectomy, percutaneous endoscopic discectomy (PELD), endoscopic discectomy, and most recently plasma disc decompression using radiofrequency energy, often referred to using the proprietary terms Coblation® or DISC nucleoplasty™.

 

Spinal decompression

Image-guided minimally invasive spinal decompression is a percutaneous procedure for decompression of the central spinal canal in patients with spinal stenosis and hypertrophy of the ligamentum flavum. Spinal stenosis can occur in the cervical, thoracic, or lumbar regions of the spine. In spinal stenosis, the space around the spinal cord narrows, compressing the spinal cord and its nerve roots. Narrowing is most often caused by osteophyte formation, herniated discs or thickened ligaments (ligamentum flavum). Spinal stenosis is often linked to age-related changes in disc height and arthritis of the facet joints. The goal of surgical treatment is to "decompress" the spinal cord and/or nerve roots. Image-guided minimally invasive spinal decompression is proposed as an alternative to existing posterior decompression procedures.

 

Vertos mild® instructions for use state that the devices are not intended for disc procedures but rather for tissue resection at the perilaminar space, within the interlaminar space, and at the ventral aspect of the lamina. These devices are not intended for use near the lateral neural elements and remain dorsal to the dura using image guidance and anatomical landmarks.

 

Discectomy

Cervical Discectomy

The most common procedure for cervical discectomy is anterior cervical discectomy. This is an open procedure in which the cervical spine is approached through an incision in the anterior neck. Soft tissues and muscles are separated to expose the spine. The disc is removed using direct visualization. This procedure can be done with or without spinal fusion, but most commonly it is performed with fusion. There have been recent procedures developed to provide cervical discectomy percutaneously and endoscopically. These procedures do not have high-quality comparative trials vs standard discectomy and will therefore not be considered as true alternatives to discectomy.

 

Lumbar Discectomy

Lumbar discectomy can be performed by a variety of surgical approaches. Open discectomy is the traditional approach. In open discectomy, a 2- to 3-cm incision is made over the area to be repaired. The spinal muscles are dissected, and a portion of the lamina may be removed to allow access to the vertebral space. The extruded disc is removed either entirely or partially using direct visualization. There have been recent procedures developed to provide lumbar discectomy percutaneously and endoscopically. These procedures do not have high-quality comparative trials vs standard discectomy and will therefore not be considered as true alternatives to discectomy.

 

Automated Percutaneous Discectomy

Automated percutaneous lumbar discectomy (APLD), also called arthroscopic microdiscectomy, is a minimally invasive surgical technique for treatment of herniated intervertebral discs. For this procedure, a thin, blunt-tipped suction and cutting probe such as the Stryker Dekompressor® Percutaneous Discectomy Probe, or the Endius® MDS MicroDebrider System, is inserted percutaneously and the terminal portion of the probe is placed into the herniated disc using fluoroscopic guidance. The device is used to suction out some or all of the degenerated central disc tissue.

 

Automated Endoscopic Discectomy

Endoscopic techniques may be intradiscal or may involve extraction of noncontained and sequestered disc fragments from inside the spinal canal using an interlaminar or transforaminal approach. Following insertion of the endoscope, decompression is performed under visual control.

 

Laser Discectomy

A variety of different lasers have been investigated for laser discectomy, including YAG, KTP, holmium, argon, and carbon dioxide lasers. Regardless of the type of laser, the procedure involves placement of the laser within the nucleus under fluoroscopic guidance and then activated. Due to differences in absorption, the energy requirements and the rate of application differ among the lasers. In addition, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary according to the length of treatment, but typically the laser is activated for brief periods only.

 

Coblation

The Disc nucleoplasty™ procedure uses bipolar radiofrequency energy in a process referred to as Coblation technology. The technique consists of small, multiple electrodes that emit a fraction of the energy required by traditional radiofrequency energy systems. The result is that a portion of nucleus tissue is ablated not with heat, but with a low-temperature plasma field of ionized particles. These particles have sufficient energy to break organic molecular bonds within tissue, creating small channels in the disc. The proposed advantage of this Coblation technology is that the procedure provides for a controlled and highly localized ablation, resulting in minimal therapy damage to surrounding tissue.

 

Percutaneous Lysis of Adhesions

Lysis of epidural adhesions, also called the Racz procedure, involves passage of a catheter (Racz catheter) endoscopically or percutaneously, using fluoroscopic guidance, with epidural injections of hypertonic saline in conjunction with corticosteroids and analgesics, has been investigated as a treatment option. Theoretically, the use of hypertonic saline results in a mechanical disruption of the adhesions. It may also function to reduce edema within previously scarred and/or inflamed nerves. Finally, manipulating the catheter at the time of the injection may disrupt adhesions. Spinal endoscopy has been used to guide the lysis procedure, but the procedure is more commonly performed percutaneously using epidurography to guide catheter placement and identify nonfilling adhesions that indicate epidural scarring. Using endoscopy guidance, a flexible fiberoptic catheter is inserted into the sacral hiatus, providing 3-D visualization to steer the catheter toward the adhesions, to more precisely place the injectate in the epidural space and onto the nerve root. Various protocols for lysis have been described; in some situations, the catheter may remain in place for several days for serial treatment sessions.

 

Percutaneous Intradiscal and Intraosseous Radiofrequency Procedures of the Spine

Electrothermal intradiscal annuloplasty therapies use radiofrequency energy sources to treat discogenic low back pain arising from annular tears. These annuloplasty techniques are designed to decrease pain arising from the annulus by thermocoagulating nerves in the disc and tightening of annular tissue.

 

A number of electrothermal intradiscal procedures have been introduced to treat discogenic low back pain; they rely on various probe designs to introduce radiofrequency (RF) energy into the disc. It has been proposed that heat-induced denaturation of collagen fibers in the annular lamellae may stabilize the disc and potentially seal annular fissures and that pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.

 

The intradiscal electrothermal annuloplasty (IDEA) procedure, a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. Using indirect radiofrequency energy, electrothermal heat is generated within the thermal resistive coil at a temperature of 90 degrees centigrade; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with IDEA include precise temperature feedback and control, and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct radiofrequency needle.

 

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) uses direct application of radiofrequency energy. With PIRFT, the radiofrequency probe is placed into the center of the disc, and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics RF Disc Catheter System has been specifically designed for this purpose.

 

Intradiscal biacuplasty involves the use of two cooled radiofrequency electrodes placed on the posterolateral sides of the intervertebral annulus fibrosus. It is believed that by cooling the probes a larger area may be treated than could occur with a regular needle probe.

 

Annuloplasty using a laser-assisted spinal endoscopy (LASE) kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty or PELA) has also been described.

 

Vertebral body endplates have been proposed as a source of lower back pain, caused by intraosseous nerves. The basivertebral nerve (BVN) enters the posterior vertebral body and sends branches to the superior and inferior endplates. Vertebrogenic pain, transmitted via the BVN, has been purported to occur with endplate damage or degeneration.

 

Summary of Evidence

For individuals who have discogenic back pain who receive intradiscal thermal annuloplasty, the evidence includes a small number of randomized controlled trials (RCTs). Two RCTs on intradiscal electrothermal annuloplasty reported conflicting results, with one reporting benefit for intradiscal electrothermal annuloplasty and the other reporting no benefit. Further study in a sham-controlled trial with a representative population of patients is needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

For individuals who have discogenic back pain who receive intradiscal radiofrequency annuloplasty, the evidence includes two RCTs. Neither RCT found evidence of  benefit with the treatment. More sham-controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

For individuals who have discogenic back pain who receive intradiscal biacuplasty, the evidence includes two industry-sponsored RCTs. One trial reported significant improvements at 6 months posttreatment, but not at 1 and 3 months. The other trial also showed a significant reduction in visual analog scale (VAS) scores at 6 months that appeared to continue to the 12-month follow-up; however, it is unclear whether this trial was sufficiently powered. More sham-controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

Vertebral Body Tethering/Vertebral Body Stapling

Vertebral body stapling and vertebral body tethering are fusionless surgical procedures that have been investigated as an alternative to bracing as an intervention for scoliosis. Nickel-titanium alloy staples with shape memory are applied to the convex (outer) side of the spinal curve. In tethering, titanium pedicle screws are placed on the convexity of the vertebrae that are causing the scoliosis; a tether (a white polyethylene-terephthalate flexible cord) is attached to each of the bone screws in the vertebral bodies of the spine. When the tether is tightened, it compresses the adjacent screws to help straighten the spine. The goal of vertebral body stapling and vertebral body tethering is to unilaterally reduce the rate of spine growth thus allowing the other side to “catch up”.

 

An assessment by the ECRI Institute regarding vertebral body tethering system for treating scoliosis states there is limited evidence from 1 small cohort study in Tether’s FDA Humanitarian Device Exemption (HDE) application suggests the Tether reduced spinal curvature and maintained the curvature correction through 24-month follow-up; however, the study has a high risk of bias and includes too few data on patient-centered outcomes (e.g., disability, quality of life). Larger, multicenter studies that follow patients until skeletal maturity are needed to validate these findings and compare the Tether to spinal fusion surgery.

 

Sacroiliac Joint Fusion

Sacroiliac joint fusion, whether performed as an open or minimally invasive (percutaneous) surgical procedure, with or without bone grafts and other metal implant devices, has been proposed as a treatment for individuals who are unresponsive to or cannot tolerate other therapy for chronic low back pain due to sacroiliac joint syndrome and other pain-related sacroiliac conditions.

 

Sacroiliac Joint Syndrome-Sacroiliac joint problems are referred to by varying terms, including sacroiliac joint dysfunction, sacroiliac joint inflammation, sacroiliac joint strain, and sacroiliac joint syndrome. Each of these terms refers to a condition that causes pain in the sacroiliac joint area from a variety of causes. Individuals often experience pain in the lower back and hips, but pain may also be present in the groin and thighs; this pain is often aggravated by any form of movement including sitting, lifting, running or walking.

 

In practice, it is very difficult to diagnose patients with sacroiliitis and it’s often mistaken for other types of back pain, as the studies indicate. The cause of sacroiliac joint inflammation and pain can be difficult to diagnose since the sacroiliac joint is not easily palpated or manipulated, radiographs or other imaging studies are often normal, and other conditions (for example, degenerative arthritis, lower back pain, sciatica) can cause similar symptoms. The diagnosis is frequently verified as originating from the SI joint via provocative physical exam maneuvers/tests including (for further informaton on individual testing see Policy Guidelines)

  • Thigh thrust test
  • Compression test
  • Gaenslen maneuver
  • Distraction test
  • Patrick sign/Fabere

 

Clinical Context and Therapy Purpose

The purpose of sacroiliac joint (SIJ) fixation/fusion with a cylindrical threaded implant is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

 

Populations

The relevant population of interest is individuals with SIJ pain.

 

Interventions

The therapy being considered is SIJ fixation/fusion with a cylindrical threaded implant.

 

Comparators

The following therapy is currently being used to treat SIJ pain: conservative therapy.

 

Outcomes

The general outcomes of interest are symptoms (eg, reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up from 1 to 5 years is of interest to monitor outcomes.

 

In 2017, the BCBSA sought clinical input from physician specialty societies and academic medical centers to help determine whether the use of sacroiliac joint (SIJ) fusion for individuals with SIJ pain would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice.  In response to requests, clinical input was received from 10 respondents, including 5 specialty society-level responses from 7 specialty societies (2 were joint society responses) and 5 physician-level responses from 4 academic centers while this policy was under review in 2017.

 

For carefully selected patients as outlined in statements from the North American Spine Society who have SIJ pain who receive percutaneous and minimally invasive techniques of SIJ fusion, the clinical input supports that this use provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

 

Practice Guidelines and Position Statements

In April 2013, the American Society of Interventional Pain Physicians published a guideline update titled “An Update of Comprehensive Evidence-based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part II: Guidance and Recommendations” in the journal Pain Physician. In this update, authors assessed the recommendation for a number of variations of percutaneous lumbar discectomy. The recommendations state: "The evidence for various modes of percutaneous disc decompression is limited to fair for nucleoplasty and limited for [automated percutaneous lumbar discectomy] APLD, percutaneous lumbar disc decompression, and decompressor."

 

International Society for the Advancement of Spine Surgery (2015)

Patients who have all of the following criteria may be eligible for minimally invasive SIJ fusion:

  • Significant SIJ pain (e.g., pain rating at least 5 on the 0-10 numeric rating scale where 0 represents no pain and 10 represents worst imaginable pain) or significant limitations in activities of daily living;
  • SIJ pain confirmed with at least 3 physical examination maneuvers that stress the SIJ and cause the patient’s typical pain.
  • Confirmation of the SIJ as a pain generator with ≥ 75% acute decrease in pain upon fluoroscopically guided diagnostic intra-articular SIJ block using local anesthetic.
  • Failure to respond to at least 6 months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or opioids (if not contraindicated) and one or more of the following: rest, physical therapy, SIJ steroid injection. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability;
  • Additional or alternative diagnoses that could be responsible for the patient’s ongoing pain or disability have been ruled out (e.g., L5/S1 compression, hip osteoarthritis).

 

Minimally invasive SIJ fusion is NOT indicated for patients with the following:

  • Less than 6 months of back pain;
  • Failure to pursue conservative treatment of the SIJ (unless contra-indicated);
  • Pain not confirmed with a diagnostic SIJ block;
  • Existence of other pathology that could explain the patient’s pain.

 

In rare instances, bilateral SIJ pain can occur. Diagnosis of bilateral SI joint pain must be made on the basis of a history of bilateral pain, bilateral elicitation of pain on physical examination maneuvers that stress each SIJ, and acute bilateral decrease in pain upon fluoroscopically-guided intra-articular SI joint block with local anesthetic.

 

Bilateral SIJ fusion is probably best performed serially to ensure that fusion of both joints is necessary (i.e., pain/disability continues after the first fusion in spite of conservative treatment and a nerve block of the unfused joint results in more than 75% reduction in pain). If bilateral fusion is performed at the same operative session, the surgeon must document both medical necessity and why serial fusion is not indicated in the patient.

 

It is expected that a person would not undergo more than one SIJ fusion per side per lifetime except in the rare case that a revision is needed.

 

North American Spine Society

In 2015 North American Spinal Society wrote a positive guideline: Due to the relatively moderate evidence, it is particularly critical that inclusion criteria are scrutinized, and patient selection is executed with vigilance. The procedure itself has proven to be relatively safe. There is a valid concern for bias in that the overwhelming majority of the data produced so far has been industry-sponsored and generally composed of case series. However, there are data on five-year outcomes that demonstrate sustained benefit that does not appear to degrade from 1 year to 5 year time-points. The committee will revisit the quality of forthcoming evidence as it is produced in re-evaluations of the indications and coverage of this procedure.

 

At this time, no evidence-based guidelines regarding sacroiliac spinal fusion procedures are available from the American Association of Neurological Surgeons (AANS), American Academy of Orthopaedic Surgeons (AAOS) or the American Pain Society (APS).

 

National Institute for Health and Care Excellence (NICE)

National Institute for Health and Clinical Excellence’s guideline on “Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain” (NICE, 2018) provides the following recommendations:

  • 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.
  • Conservative treatments for SI joint pain include analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, manipulative therapy, intra-articular SI joint corticosteroid injections, periarticular injections, botulinum toxin injections and radiofrequency denervation. Surgical treatment is considered for persistent chronic symptoms that are unresponsive to conservative treatment. Surgical techniques include open SI joint fusion surgery or minimally invasive SI joint fusion using percutaneous implants to stabilize the joint and treat joint pain.

 

Regulatory Status

The mild® tool kit (Vertos Medical Inc., San Jose, CA) initially received 510(k) marketing clearance as the X-Sten MILD Tool Kit (X-Sten Corp.) from the US Food and Drug Administration (FDA) on December 19, 2006, as a class II device with intended use as a set of specialized surgical instruments to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions. A subsequent approval for the Vertos Medical mild® Device Kit (Vertos Medical Inc.) was given by the FDA on February 4, 2010.

 

A number of percutaneous or minimally invasive fixation/fusion devices have been cleared for marketing by the FDA through the 510(k) process. They include the iFuse® Implant System (SI Bone), the Rialto™ SI Joint Fusion System (Medtronic), SIJ-Fuse (Spine Frontier), the SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies), Silex™ Sacroiliac Joint Fusion System (STANT Medical), SambaScrew® (Orthofix), and the SI-LOK Sacroiliac Joint Fixation System (Globus Medical).

 

SI-Bone, Inc. originally received FDA 510K marketing clearance for the iFuse system in November 2008 for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac join disruptions and sacroiliitis. In March 2011, the FDA removed “fracture” from the intended use and gave marketing clearance for the iFuse system for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

 

Several other percutaneous or minimally invasive fixation/fusion devices have been cleared for marketing by the federal Food and Drug Administration. They include the SI-FIX Sacroiliac Joint Fusion System (Medtronic), the SImmetry® Sacroiliac Joint Fusion System (Zyga Technologies), Silex® Sacroiliac Joint Fusion System (Xtant Medical) and the SI-LOK® Sacroiliac Joint Fixation System (Globus Medical).

 

A variety of radiofrequency (RF) coagulation devices are cleared for marketing by the U.S. Food and Drug Administration (FDA), some of which are designed for disc nucleotomy. In 2002, the Oratec Nucleotomy Catheter (ORATEC Interventions, Menlo Park, CA, acquired by Smith & Nephew in 2002) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. Radionics (a division of Tyco Healthcare group) RF (Radiofrequency) Disc Catheter System received marketing clearance through FDA’s 510(k) process in 2000.

 

The Baylis Pain Management Cooled Probe received marketing clearance through the FDA’s 510(k) process in 2005. It is intended for use “in conjunction with the Radio Frequency Generator to create radiofrequency lesions in nervous tissue.”

 

The Intracept Intraosseous Nerve Ablation System “is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care”. FDA reviewed the device and issued a substantially equivalent designation in August 2017 (K170827).

 

Prior Approval:

Not applicable

 

Policy:

Sacroiliac Joint (SIJ) Fusion Surgery

Open Sacroiliac joint (SIJ) fusion is considered medically necessary for any of the following indications:

  1. As an adjunct to sacrectomy or partial sacrectomy related to tumors involving the sacrum; or
  2. As an adjunct to the medical treatment of sacroiliac joint infection/sepsis; or
  3. Severe traumatic injuries associated with pelvic ring fracture; or
  4. During multisegment spinal constructs (for example, correction of deformity in scoliosis or kyphosis surgery) extending to the ilium.

 

Open sacroiliac joint (SIJ) is considered investigational when the above criteria is not met and including, but not limited to the following because the evidence is insufficient to determine the effects of this technology on net health outcomes:

  • mechanical low back pain
  • sacroiliac joint syndrome
  • degenerative sacroiliac joint
  • radicular pain syndromes 

 

Minimally Invasive Sacroiliac Joint (SIJ) Fusion

Unilateral percutaneous or minimally invasive fusion or stabilization of the sacroiliac joint, with a maximum of 3 titanium triangular implants per joint, may be considered medically necessary when ALL of the following criteria is met:

  1. Individual is at least 18 years old; and
  2. Individual has undergone and failed a minimum 6 months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise (physical therapy*) targeted at the lumbar spine, pelvis, sacroiliac joint, and hip, including a home exercise program; and
  3. Pain is consistently at least a 5 on a 0 to 10 rating scale, that impacts quality of life (QOL) and limits activities of daily living (ADLs); and
  4. There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); and
  5. Individuals pain is reported as non-radiating, unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain; and
  6. On physical examination documented in the individuals medical records demonstrates localized tenderness with palpation over sacral sulcus (Fortin’s point) in the absence of tenderness of similar severity elsewhere (e.g., greater trochanter, lumbar spine, coccyx); and
  7. There is a positive response to 3 provocative tests:
    1. Thigh thrust test
    2. Compression test
    3. Gaenslen sign
    4. Distraction test
    5. Patrick test; and
  8. 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
  9. There is at least a 75% reduction in pain following an image-guided intra-articular sacroiliac joint injection on 2 separate occasions within the last 12 months; and
  10. A trial of therapeutic sacroiliac joint injection (i.e., corticosteroid injection) has been performed on at least once within the last 12 months.

 

*Note: Formal physical therapy, at least six visits over a six-week course, including active muscle conditioning is required. The requirement for physical therapy will not be met if there is a failure to complete prescribed physical therapy for non-clinical reasons. Documentation of formal physical therapy would be the therapist’s notes.

 

Unilateral percutaneous or minimally invasive fusion or stabilization of the sacroiliac joint not meeting the above criteria will be considered not medically necessary.

 

Required Documentation for Minimally Invasive Sacroiliac Fusions ONLY:

Medical records submitted for review need to include ALL of the following:

  1. Specific device to be implanted; and
  2. History of moderate to severe pain of at least 6 months duration including date of onset; and
  3. Location and description of pain, and at least 3 provocative tests and results indicating pain arising from the sacroiliac joint; and
  4. Documentation of the absence of generalized pain behavior or generalized pain disorders; and
  5. Procedure report describing at least TWO SI joint anesthetic injections and follow-up reports on the percent change in the level of pain, for the duration of the specific local anesthetic used; and
  6. Trial of therapeutic injection (e.g. corticosteroid) including response; and
  7. Conservative non-surgical therapy:
    • Medical management with NSAIDs or other analgesics; and
    • Physical therapy or documentation must include clinical notes from the physical therapist describing the patient's inability to complete PT; and
  8. Radiology reports (plain radiographs and a CT OR MRI) of the following:
    • Hip/pelvis
    • Lumbar spine
    • Sacroiliac joint

 

The following procedures are considered investigational for all indications, because the evidence is insufficient to determine the effects of this technology on net health outcomes: 

  • Image-guided minimally invasive decompression for the treatment of spinal stenosis
  • Discectomy
    • Automated percutaneous lumbar, thoracic and cervical discectomy
    • Percutaneous endoscopic discectomy (PELD)
    • Laser discectomy and intervertebral disc decompression using radiofrequency energy, including but not limited to Coblation® and DISC nucleoplasty
  • Percutaneous lysis of epidural adhesions, with or without endoscopic guidance
  • Vertebral body stapling and vertebral body tethering
  • Intradiscal annuloplasty including but not limited to the following:
    • Intradiscal electrothermal annuloplasty (IDEA)
    • Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)
    • Intradiscal biacuplasty
  • Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept system)

 

Policy Guidelines

Provocative tests of the sacroiliac region may indicate sacroiliac joint dysfunction when at least 3 different tests reproduce the patient’s typical pain in the SI region, including: 

  • Thigh thrust: Test involves the examiner applying downward pressure along the femur with the patient supine. Pain at the ilium or SI joint suggests SI joint dysfunction.
  • Compression test: Also called the approximation test, stresses the SI joint structures, in particular the posterior SI joint ligament, to attempt to replicate the patient’s symptoms.
  • Gaenslen sign: Is accomplished with the patient supine. One hip is flexed by pushing the patient’s knee to their chest, while simultaneously extending the opposite hip joint. This maneuver stresses both sacroiliac joints. Posterior pelvic pain indicates a positive test. 
  • Distraction test: Also known as the gaping test, is positive for pain sacroiliac joint dysfunction or other pelvic abnormalities when downward pressure is applied simultaneously to the iliac crest when the patient is in supine position. 
  • Patrick sign is also referred to as the Fabere test: The examiner Flexes, Abducts, Externally Rotates, and Extends the affected leg so that the ankle of that leg is on top of the opposite knee (a figure of 4 configuration). The affected leg is then slowly lowered toward the examining table. A negative result occurs when the test leg falls at least parallel to the opposite leg. A positive test result occurs when the affected leg remains above the opposite leg and pain arises unilaterally in the active hip.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT codes, HCPCS codes, Revenue codes, and/or ICD diagnostic codes.

  • C2614 Probe, percutaneous lumbar discectomy
  • C9752 Destruction of intraosseous basivertebral nerve bodies, including imaging guidance (e.g. fluoroscopy), lumbar/sacrum
  • C9753 Destruction of intraosseous basivertebral, each additional vertebral body, including imaging guidance (e.g. fluoroscopy), lumbar/sacrum (list separately in addition to code for primary procedure)
  • C9757 Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and excision of herniated intervertebral disc, and repair of annular defect with implantation of bone anchored annular closure device, including annular defect measurement, alignment and sizing assessment, and image guidance; 1 interspace, lumbar
  • G0276 Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trila
  • S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar
  • 0274T Percutaneous laminotomy/laminectomy (intralaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy) any method under indirect image guidance (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; cervical or thoracic
  • 0275T Percutaneous laminotomy/laminectomy (intralaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy) any method under indirect image guidance (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar
  • 0656T Vertebral body tethering, anterior; up to 7 vertebral segments
  • 0657T Vertebral body tethering, anterior; 8 or more vertebral segments
  • 22526 Percutaneous intradiscal electrotherapy annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level
  • 22527 Percutaneous intradiscal electrotherapy annuloplasty, unilateral or bilateral including fluoroscopic guidance; 1 or more additional levels (list separately in addition to code for primary procedure)
  • 27279 Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device
  • 27280 Arthrodesis, open, sacroiliac joint, including obtaining bone graft, including instrumentation, when performed
  • 22899 Unlisted procedure, spine
  • 27299 Unlisted procedure, pelvis or hip joint
  • 62263 Percutaneous lysis of epidural adhesions using solution injection (eg, hypertonic saline, enzyme) or mechanical means (eg, catheter) including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 2 or more days
  • 62264 Percutaneous lysis of epidural adhesions using solution injection (eg, hypertonic saline, enzyme) or mechanical means (eg, catheter) including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 1 day
  • 62287 Aspiration or decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (eg, manual or automated percutaneous discectomy, percutaneous laser discectomy)
  • 62380 Endoscopic decompression of spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar

 

Selected References:

  • Boswell MV, Trescot AM, et al.  Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain.  Pain Physician 2007; 10:7-111.
  • Singh V, Manchikanti L, Calodney AK et al. Percutaneous lumbar laser disc decompression: an update of current evidence. Pain Physician 2013; 16(2 Suppl):SE229-60.
  • Manchikanti L, Falco FJ, Benyamin RM et al. An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty. Pain Physician 2013; 16(2 Suppl):SE25-54.
  • ECRI Institute Percutaneous discectomy for treating herniated lumbar disc. ECRI Health Technology Information Service; 2013 December 27. [Hotline Response].
  • Vleeming A, Albert HB, Ostgaard HC, et al. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008; 17(6):794-819.
  • U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. SImmetry™ Sacroiliac Joint Fusion System Summary of Safety and Effectiveness. No. K11051 Rockville, MD: FDA. March 23, 2011.
  • North American Spine Society (NASS). NASS coverage policy recommendations: Percutaneous sacroiliac joint fusion. 2015; North American Spine Society
  • Zheng Y, Gu M, Shi D, et al. Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for ankylosing spondylitis: a open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014;34(9):1195-1202. PMID 24518967
  • Althoff CE, Bollow M, Feist E, et al. CT-guided corticosteroid injection of the sacroiliac joints: quality assurance and standardized prospective evaluation of long-term effectiveness over six months. Clin Rheumatol. Jun 2015;34(6):1079-1084. PMID 25896531
  • Hayes, Winifred S. Health Technology Brief. iFuse Implant System (SI-BONE Inc.) for sacroiliac joint fusion for treatment of low back pain. October 8, 2015.
  • Miller, LE, Reckling, WC, and Block, JE. Analysis of postmarket complaints database for the iFuse SI Joint Fusion System(R): a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Med Devices (Auckl). 2013;677-84. PubMed 23761982 [PMID]
  • Zaidi, HA, Montoure, AJ, and Dickman, CA. Surgical and clinical efficacy of sacroiliac joint fusion: a systematic review of the literature. J Neurosurg Spine. 2015;23(1):59-66. PubMed 25840040
  • Lingutla, KK, Pollock, R, and Ahuja, S. Sacroiliac joint fusion for low back pain: a systematic review and meta-analysis. Eur Spine J. 2016.PubMed 26957096
  • Cher DJ, Reckling WC, Capobianco RA. Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System((R)). Med Devices (Auckl). 2015;8:485-492. PMID 26648762
  • Blue Cross and Blue Shield Association Evidence street, Diagnosis and Treatment of Sacroiliac Joint Pain. December 2016.
  • Polly DW, Swofford J, Whang PG, 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. Int J Spine Surg. 2016;10:28. PMID 27652199
  • Whang P, Cher D, Polly D, et al. Sacroiliac joint fusion using triangular titanium implants vs. non-surgical management: six-month outcomes from a prospective randomized controlled trial. Int J Spine Surg. 2015;9:6. PMID 25785242
  • Duhon BS, Bitan F, Lockstadt H, et al. Triangular titanium implants for minimally invasive sacroiliac joint fusion: 2-year follow-up from a prospective multicenter trial. Int J Spine Surg. 2016;10:13. PMID 27162715
  • 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. PMID 27471413
  • Bina RW and Hurlbert RJ(2017) Sacroiliac fusion: another "Magic Bullet" destined for disrepute. Neurosurg Clin N Am. 2017 Jul;28(3):313-320.
  • Sturesson B, Kools D, Pflugmacher R, et al. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. 2017; 26(3):708-719.
  • Dengler JD, Kools D, Pflugmacher R, et al. 1-year results of a randomized controlled trial of conservative management vs. minimally invasive surgical treatment for sacroiliac joint pain. Pain Physician. 2017; 20(6):537-550.
  • Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-year comparative case series. Neurosurgery. 2018; 82(1):48-55.
  • Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). May 1 2009;34(10):1066-1077. PMID 19363457
  • Kancherla VK, McGowan SM, Audley BN, et al. Patient reported outcomes from sacroiliac joint fusion. Asian Spine J. 2017;11(1):120-126.
  • National Institute for Health and Clinical Excellence (NICE). Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. Interventional Procedures Guidance 578. London, UK: NICE; April 5, 2017
  • Bornemann R, Roessler PP, Strauss A, et al. 2-year clinical results of patients with sacroiliac joint syndrome treated by arthrodesis using a triangular implant system. Technol Health Care. 2017;25(2):319-325.
  • Scoliosis Research Society (SRS). Adolescent Idiopathic Scoliosis. n.d.
  • Cuddihy L, Danielsson AJ, Cahill PJ, et al. Vertebral body stapling versus bracing for patients with high-risk moderate idiopathic scoliosis. Biomed Res Int. Dec 2015;2015:438452. PMID 26618169
  • Bumpass DB, Fuhrhop SK, Schootman M, et al. Vertebral body stapling for moderate juvenile and early adolescent idiopathic scoliosis: cautions and patient selection criteria. Spine (Phila Pa 1976). Dec 2015;40(24):E1305-1314. PMID 26655807
  • Betz RR, Ranade A, Samdani AF, et al. Vertebral body stapling: a fusionless treatment option for a growing child with moderate idiopathic scoliosis. Spine. Jan 15 2010;35(2):169-176. PMID 20081512
  • Samdani AF, Ames RJ, Kimball JS, et al. Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: one-year results on the first 32 patients. Eur Spine J. Jul 2015;24(7):1533-1539. PMID 25510515
  • Cong L, Zhu Y, Tu G. A meta-analysis of endoscopic discectomy versus open discectomy for symptomatic lumbar disk herniation. Eur Spine J. 2016;25(1):134-143.
  • Gibson JN, Subramanian AS, Scott CE. A randomised controlled trial of transforaminal endoscopic discectomy vs microdiscectomy. Eur Spine J. Mar 2017;26(3):847-856. PMID 27885470
  • Sun HH, Zhuang SY, Hong X, et al. The efficacy and safety of using cooled radiofrequency in treating chronic sacroiliac joint pain: A PRISMA-compliant meta-analysis. Medicine (Baltimore). Feb 2018;97(6):e9809. PMID 29419679
  • Cross WW, Delbridge A, Hales D, Fielding LC. Minimally invasive sacroiliac joint fusion: 2-year radiographic and clinical outcomes with a principles-based SIJ fusion system. Sacroiliac Joint Fusion. Open Orthop J. 2018;12:7-16.
  • Darr E, Meyer SC, Whang PG, et al. Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2018;11:113–121. Published 2018 Apr 9. doi:10.2147/MDER.S160989
  • Duhon BS, Bitan F, Lockstadt H, et al. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:13. Published 2016 Apr 20. doi:10.14444/3013
  • Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally invasive sacroiliac joint fusion, radiofrequency denervation, and conservative management for sacroiliac joint pain: 6-year comparative case series. Neurosurgery. 2018;82(1):48-55.
  • National Institute for Health and Clinical Excellence (2018) iFuse for treating chronic sacroiliac joint pain, medical technologies guidance 2 October 2018
  • Staats PS, Chafin TB, Golovac S, et. al. Long-term safety and efficacy of minimally invasive lumbar decompression procedure for the treatment of lumbar spinal stenosis with neurogenic claudication: 2 year results of MiDAS ENCORE. Reg Anesth Pain Med 2018 Oct:43(7):789-794. PMID 30199512  
  • Benyamin RM, Staats PS, MiDAS Encore. MILD ® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE randomized controlled trial. Pain Physician May 2016;19(4):229-242. PMID 27228511
  • Kreiner DS, MacVicar J, Duszynski B, et. al. The mild procedure: a systematic review of the current literature. Pain Med 2014 Feb;15(2):196-205. PMID 24308292
  • Chopko BW, Long-Term Results of Percutaneous Lumbar Decompression for LSS: Two Year Outcomes, Clin J Pain 2013 Nov;29(11):939-43
  • National Guideline Clearing House. North American Spine Society, Diagnosis and Treatment of Lumbar Spondylolisthesis. Also available at North American Spine Society (NASS) 2014, p.119
  • CMS National Coverage Determination (NCD) for Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (150.13).
  • Chen CH, Weng PW, Wu LC et al.(2019) Radiofrequency neurotomy in chronic lumbar and sacroiliac joint pain: A meta-analysis. Medicine (Baltimore), 2019 Jul 3;98(26). PMID 31261580
  • Tran ZV, Ivashchenko A, Brooks L.(2019) Sacroiliac Joint Fusion Methodology - Minimally Invasive Compared to Screw-Type Surgeries: A Systematic Review and Meta-Analysis. Pain Physician, 2019 Feb 1;22(1). PMID 30700066
  • Deer TR, Grider JS, Pope JE et al. The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment. Pain Pract. 2019 Mar;19(3). PMID 30369003
  • Lingutla, K.K., Pollock, R. & Ahuja, S. Sacroiliac joint fusion for low back pain: a systematic review and meta-analysis. Eur Spine J. Jun 2016;25(6):1924-1931. PMID 26957096
  • Dengler J, Duhon B, Whang P, et al; INSITE, iMIA, SIFI study groups. Predictors of outcome in conservative and Diagnosis and Treatment of Sacroiliac Joint Pain 6.01.23 No. Yes/No Citations of Missing Evidence minimally invasive surgical management of pain originating from the sacroiliac joint: a pooled analysis. Spine (Phila Pa 1976). 2017 Mar 27. [Epub ahead of print] PMID: 28350586
  • Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;10.1007/s00586-020-06448
  • Fischgrund JS, Rhyne A, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. International Journal of Spine Surgery 2019; 13: 110-119
  • Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. The Spine Journal 2019; 19: 1620-1632
  • Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-1156

 

Policy History:

  • July 2021 - Annual Review, Policy Revised
  • July 2020 - Annual Review, Policy Revised
  • October 2019 - Interim Review, Policy Revised
  • July 2019 - Annual Review, Policy Revised
  • July 2018 - Annual Review, Policy Revised
  • July 2017 - Annual Review, Policy Revised
  • July 2016 - Annual Review, Policy Revised
  • October 2015 - Interim Review, Policy Revised
  • August 2015 - Annual Review, Policy Revised
  • September 2014 - Annual Review, Policy Revised
  • October 2013 - Annual Review, Policy Revised
  • November 2012 - Annual Review, Policy Renewed
  • November 2011 - Annual Review, Policy Renewed
  • October 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.