Medical Policy: 07.01.39
Original Effective Date: January 2008
Reviewed: October 2019
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.
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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.
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.
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 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.
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.
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.
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:
- Thigh thrust test
- Compression test
- Gaenslen’s maneuver
- Distraction test
- FABER/Patrick’s sign
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).
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”.
Clinical Guidelines and Recommendations
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.
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%(3,4) 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 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).
Blue Cross and Blue Shield Evidence Street (2016)
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 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.
Sacroiliac Joint Fusion Surgery
Open Sacroiliac joint fusion procedures are considered medically necessary for any of the following indications:
- 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/sepsis; OR
- Severe traumatic injuries associated with pelvic ring fracture; OR
- During multisegment spinal constructs (for example, correction of deformity in scoliosis or kyphosis surgery) extending to the ilium.
Open sacroiliac joint fusion for all other conditions are considered investigational including, but not limited to:
- mechanical low back pain
- sacroiliac joint syndrome
- degenerative sacroiliac joint
- radicular pain syndromes
Minimally Invasive SI Joint Fusion
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:
- Member is at least 18 years old;
- Member is more than one year post-partum;
- Pain is consistently at least a 5 (on a 0 to 10 rating scale), that impacts quality of life and limits activities of daily living;
- Member must have undergone and failed a minimum six months of intensive non-operative treatment that must include all of the following :medication optimization, activity modification, and formal physical therapy*;
- Patient’s report of non-radiating, unilateral pain that is caudal to the lumbar spine (L5 vertebrae), localized over the posterior SIJ, and consistent with SIJ pain;
- Localized tenderness with palpation of the posterior SIJ in the absence of tenderness of similar severity elsewhere (e.g., greater trochanter, lumbar spine, coccyx) and other obvious sources for their pain do not exist;
- Positive response to the thigh thrust test OR compression test AND 2 of the following additional tests: Gaenslen’s test, distraction test, Patrick’s sign;
- Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia);
- 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;
- Absence in the spinal column of infection, tumor, osteoporosis, or fracture;
- There is at least a 75% reduction in pain following an image-guided intra-articular sacroiliac joint injection on 2 separate occasions over the last year
*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 spinal decompression
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 diskectomy.
Lysis of Adhesions
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 Tethering/Vertebral Body Stapling
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.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT codes, HCPCS codes, Revenue codes, and/or ICD diagnostic codes.
- 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
- C2614 Probe, percutaneous lumbar discectomy
- 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
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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.
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