Medical Policy: 07.01.39
Original Effective Date: January 2008
Reviewed: July 2020
Revised: July 2020
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 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.
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. The former category includes 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™.
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.
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 has 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 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 has 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 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.
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.
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.
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.
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.
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)
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”.
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. 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.
Patients who have all of the following criteria may be eligible for minimally invasive SIJ fusion:
Minimally invasive SIJ fusion is NOT indicated for patients with the following:
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.
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 some 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).
For individuals who have SIJ pain who receive SIJ fusion, the evidence includes 2 RCTs of minimally invasive fusion and a number of case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Both nonblinded RCTs reported superior short-term results for fusion, but there is potential for bias because of unblinded controls and because the trials used self-reported outcomes. Three case series of reasonable size and good follow-up showed that benefits obtained at 6 months persist to 2 years. One small case series showed good outcomes persist to 5 years. The case series are consistent with durability of treatment benefit, but only if there is a true benefit of treatment. Reports from adverse effects monitoring, registries, and administrative data raise uncertainty about net health outcome achievable in clinical practice. The evidence is insufficient to determine the effects of the technology on health outcomes.
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:
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.
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).
Open Sacroiliac joint fusion procedures are considered medically necessary for any of the following indications:
Open sacroiliac joint fusion for all other conditions are considered investigational including, but not limited to:
Unilateral percutaneous minimally invasive fusion/stabilization of the sacroiliac joint, with a maximum of 3 implants per joint, may be considered medically necessary when ALL of the following criteria is met:
*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.
Lack of clinical documentation for support of all criteria points above will result in the procedure being denied as not medically necessary.
Percutaneous minimally invasive fixation/fusion of the sacroiliac joint for the treatment of back pain presumed to originate from the sacroiliac joint is considered investigational with any devices not FDA approved.
Image-guided minimally invasive decompression for the treatment of spinal stenosis is considered investigational due to a lack of clinical evidence demonstrating an impact on improved health outcomes.
The available evidence is insufficient to determine the efficacy of image-guided minimally invasive lumbar decompression compared with placebo (control) or to determine the efficacy of image-guided minimally invasive lumbar decompression compared with open decompression. In addition, the complication rates and reoperation rates for this procedure compared with those of decompression surgery is unknown. Trials with relevant control groups could provide greater certainty on the risk and benefits of this procedure.
There is no evidence to inform conclusions about the use of image-guided minimally invasive cervical or thoracic decompression to treat cervical or thoracic spinal stenosis.
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™, are considered investigational as techniques of disc decompression and the treatment of associated pain.
There is insufficient evidence to permit conclusions on net health outcomes in the absence of well-designed and executed randomized controlled trials with adequate follow-up. There are no high-quality trials addressing the use of thoracic and cervical percutaneous discectomy at this time.
Clinical studies have not established any clinically significant benefit of use of a laser over use of a scalpel for percutaneous lumbar, thoracic, and cervical discectomy.
Percutaneous lysis of epidural adhesions, with or without endoscopic guidance, are considered investigational. Techniques used either alone or in combination include mechanical disruption with a catheter and/or injection of hypertonic solutions with steroids, analgesics, or hyaluronidase.
Vertebral body stapling and vertebral body tethering is considered investigational including but not limited to the treatment of scoliosis.
Evidence on the use of vertebral body stapling for patients with idiopathic scoliosis consists of a nonrandomized comparative study and several small case series. The use of vertebral body tethering is not fully FDA approved at this time. For both vertebral body stapling and vertebral body tethering there is limited published evidence and lack of long-term outcomes.
Clinical evidence comparing conventional (open approach) procedures to endoscopic procedures including, but not limited to, discectomy, disc decompression, and image-guided minimally invasive decompression are needed. High quality randomized controlled trials with sufficiently large sample sizes and longer follow-up periods are needed to determine if percutaneous and endoscopic spinal surgery procedures are more effective than conventional (open approach) procedures. There are no published trials comparing other minimally invasive techniques (eg, laser-assisted discectomy) versus open discectomy, microdiscectomy, or nonsurgical therapy. There remains substantial uncertainty due to insufficient evidence comparing the mild procedure with other minimally invasive surgical procedures currently.
For minimally invasive sacroiliac fusions ONLY:
Clinical notes indicating ALL of the following:
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’s test 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’s 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.
To report provider services, use appropriate CPT codes, HCPCS codes, Revenue codes, and/or ICD diagnostic codes.
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*CPT® is a registered trademark of the American Medical Association.