Medical Policy: 07.01.39
Original Effective Date: January 2008
Reviewed: July 2016
Revised: July 2016
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, and most recently plasma disc decompression using radiofrequency energy, often referred to using the proprietary terms Coblation® or DISC nucleoplasty™.
Automated percutaneous lumbar discectomy (APLD) 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.
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.
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 theAmerican Pain Society (APS),).
Automated percutaneous lumbar discectomy, laser discectomy and intervertebral disc decompression using radiofrequency energy, including but not limited to Coblation® and DISC nucleoplastyTM, 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.
Clinical studies have not established any clinically significant benefit of use of a laser over use of a scalpel for percutaneous lumbar 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.
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.
Open Sacroiliac joint fusion procedures are considered medically necessary for any of the following indications:
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.
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
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.