Medical Policy: 07.01.39
Original Effective Date: January 2008
Reviewed: July 2021
Revised: July 2021
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 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™.
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 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 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 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.
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.
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 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, 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)
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.
The relevant population of interest is individuals with SIJ pain.
The therapy being considered is SIJ fixation/fusion with a cylindrical threaded implant.
The following therapy is currently being used to treat SIJ pain: conservative therapy.
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.
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."
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 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 Clinical Excellence’s guideline on “Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain” (NICE, 2018) provides the following recommendations:
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).
Open Sacroiliac joint (SIJ) fusion is considered medically necessary for any of the following indications:
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:
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:
*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.
Medical records submitted for review need to include ALL of the following:
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:
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:
To report provider services, use appropriate CPT codes, HCPCS codes, Revenue codes, and/or ICD diagnostic codes.
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