Medical Policy: 07.01.39
Original Effective Date: January 2008
Reviewed: July 2018
Revised: July 2018
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™.
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. 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.
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.
In 2012, the North American Spine Society released “Clinical Guidelines for Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy.” Recommendations state: There is insufficient evidence to make a recommendation for or against the use of tubular discectomy compared with open discectomy to improve the outcomes.
In 2015 North American Spinal Society wrote a positive guideline, the NASS coverage policy also included: 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.
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:
The current evidence on sacroiliac joint fusion is insufficient to permit conclusions regarding the clinical effectiveness of the procedures, whether performed as an open or minimally invasive (percutaneous) surgical procedure, with or without bone grafts and other metal implant devices, for individuals who are unresponsive to or cannot tolerate other therapy for chronic low back pain due to sacroiliac joint syndrome, sacral insufficiency fractures, and other pain-related sacroiliac conditions. Assessment of the data is mixed and insufficient to support long-term efficacy and safety of open sacroiliac joint fusion for the treatment of chronic back pain, or to establish its effectiveness compared with more conservative alternatives. Prospective trials with standardized selection criteria are needed to identify the role of sacroiliac joint fusion procedures in the management of individuals with these conditions refractory to conservative management.
Minimally invasive sacroiliac joint fusion and percutaneous sacroiliac joint fusion procedures, including the use of iFuse, ISymmetry, or other devices are considered investigational for all indications, including but not limited to: sacral insufficiency fractures, sacroiliac (SI) joint pain and chronic back pain. High-quality evidence supporting the effectiveness of joint implants are limited. The majority of literature consists largely of retrospective case series involving small sample groups evaluating short-term to mid-term outcomes, a systematic review and few randomized controlled trials are available. Trials evaluating safety and effectiveness are limited in number and longevity. Frequently, within the clinical information available there is a lack of comparison groups, adequate blinding, a decrease in opioid medication or evaluation and lack of long-term follow up.
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.
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.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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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