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This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.
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Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline
Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.
Coverage Rationale Epiduroscopy (including spinal myeloscopy) is unproven for the diagnosis of back pain. There is insufficient evidence to conclude that epiduroscopy can improve patient management or disease outcomes. The available studies primarily evaluated the feasibility of the procedure and the ability to visualize normal and pathological structures with an epiduroscope. None of the studies systematically evaluated the accuracy of epiduroscopy for diagnosis of causes of back pain and neurological signs.
Functional anesthetic discography (FAD) is unproven for the diagnosis of back pain. Although researchers are presently investigating the use of FAD for diagnosing discogenic pain, there is insufficient evidence at this time to draw conclusions.
Percutaneous and endoscopic epidural lysis of adhesions are unproven for the treatment of back pain.
There is insufficient evidence to conclude that epidural lysis of adhesions can provide sustained reduction in chronic back pain in patients with a presumptive diagnosis of epidural adhesions.
Studies suggest that epidural adhesiolysis provides limited, relatively short-term reductions in back pain and disability. No published studies have evaluated this procedure relative to open surgical procedures for chronic back pain. Further validation with larger study populations and long term follow up is needed to verify the effectiveness of epidural adhesiolysis in the treatment of back pain.
Regulatory Requirements U. S. Food and Drug Administration (FDA): Endoscopes, catheters, and needles that can be used for epidural lysis of adhesions are regulated by the FDA as Class II devices and a number of these devices have been approved via the FDA 510(k) process. The Racz Catheter received FDA approval on October 8, 1996 (K954584). The Myelotec Myeloscope received 510(k) approval on September 4, 1996 (K960194).
Additional information, product codes HRX, BSO, and BSP, is available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed March 31, 2009.
The FAD System (originally developed by InnoSpine, Inc., Palo Alto, CA, and later acquired by Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline Kyphon Inc., Sunnyvale, CA) received 510(k) approval through the U.S. Food and Drug Administration (FDA) in April 2005 (FDA, K043500). According to the FDA, the intended use of the system is to deliver either a single dose or continuous administration of radiopaque contrast, local
anesthetics, and/or saline solution to the intradiscal space. Additional information is available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf4/K043500.pdf. Accessed March 31, 2009.
Research Evidence Background Functional Anesthetic Discography (FAD) is a diagnostic procedure that involves injecting an anesthetic agent directly into a spinal disc. Proponents suggest FAD can be used to confirm the presence of injured discs as the source of the patient's low back pain symptoms. According to the manufacturer, FAD is designed to diagnose and potentially treat low back pain caused by degenerative disc disease. If the test does not relieve the patient's pain, the physician can investigate other possible causes of pain.
Epiduroscopy involves the percutaneous insertion of a fiberoptic endoscope into the epidural space and has been proposed as a technique to identify pathological structures such as epidural adhesions, fibrosis, and scars. This is also done with a myeloscope which is a video-guided catheter system and introducer system.
Epidural adhesiolysis typically involves injection of an anesthetic at the site of adhesions, injection of normal saline to distend and decompress the epidural space, and mechanical manipulations of the fiberoptic endoscope to cause direct disruption of fibrosis, scar tissue, or adhesions. Endoscopic and percutaneous epidural adhesiolysis may also involve injection of steroids, hypertonic saline solutions, and/or hyaluronidase into the epidural space. Another variation of this procedure involves the use of the Racz® Catheter and RK® Needle.
Research Evidence Epiduroscopy Results of earlier feasibility/observational studies suggest that epiduroscopy can aid in the visualization of the anatomy and pathology of spinal structures; in particular, the cauda equina and epidural space. However, none of these studies evaluated the impact of epiduroscopy on clinical management or patient outcomes.
Two studies concluded that epiduroscopy could identify the cause of pain and other neurological signs in some patients who had been either undiagnosed or incorrectly diagnosed by radiography or magnetic resonance imaging (MRI). Uchiyama et al. reported that in 4 out of 18 patients, epiduroscopy identified a spinal cord mass that had been diagnosed radiographically as a cyst or herniation of the spinal cord (Uchiyama, 1998). In another study, Geurts et al. reported that epiduroscopy outperformed MRI in 8 out of 20 patients with chronic sciatica with or without FBSS (Geurts, 2002). In this study, MRI findings agreed with epiduroscopy observations in 11 patients, Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline while epiduroscopy identified an adhesion on the nerve root in 8 patients in whom MRI detected no abnormalities of the spinal structures. However, this study was very small and no conclusions regarding the relative accuracy of epiduroscopy versus MRI for diagnosis of spinal cord or epidural pathology can be drawn. In this study, patients with adhesions were treated with a combination of hyaluronidase, steroid, and clonidine; this therapy appeared to provide significant pain relief in some patients, although the effect diminished within 12 months. These results were similar to those reported earlier by Richardson et al., who described reductions in pain and disability in patients with adhesions who were treated with steroids and clonidine during epiduroscopy examinations (Richardson, 2001).
Igarashi et al. conducted a study of 58 patients with degenerative lumbar spinal stenosis who were placed into 2 groups, a monosegmental or multisegmental group, based on leg symptoms (Igarashi, 2004). All patients underwent epiduroscopy with epidural injection of steroid or local anesthetic. The findings of epiduroscopy corresponded to the symptoms, and the study results demonstrated positive effects of epiduroscopy on low back pain for up to 1 year in both groups.
Professional Societies and Organizations National Institute for Health and Clinical Excellence (NICE): An assessment by NICE concluded that "current evidence on the safety and efficacy of endoscopic epidural procedures does not appear adequate for these procedures to be used without special arrangements for consent and for audit or research." The NICE assessment found that "The studies identified were small and uncontrolled.
Some measures used in these studies to assess outcomes, such as scores of pain and function, were of unknown validity." (NICE, 2004) Royal Australian College of Surgeons: The 2003 Australian Safety and Efficacy Register of New Interventional Procedures concluded "there is little high-quality evidence available on the safety and efficacy of epiduroscopically guided surgery/drug delivery. More studies are needed to compare the safety and efficacy of epiduroscopy relative to other procedures." (RACS, 2003) Functional Anesthetic Discography (FAD) No published abstracts related to functional anesthetic discography (FAD) for the diagnosis of discogenic pain were found. One group of researchers at a specific institution are investigating the use of FAD but no results have been published from any clinical trials. The same researchers have also been investigating provocative discography for several years; however, no trials comparing provocative discography with FAD were found. There is insufficient evidence to assess the safety and efficacy of FAD for the diagnosis of discogenic pain; cannot recommend adoption or use at this time. (Hayes, 2009) Luchs et al., presented their preliminary experience with FAD in the evaluation of patients with suspected discogenic low back pain at the 2007 American Roentgen Ray Society Annual Meeting (
#152, May 8th) (Luchs, 2007). For the study, investigators performed FAD in 19 patients Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline (13 men, 6 women; mean age 47.2 years) who underwent lumbar discography for suspected discogenic low back pain. A total of 29 discs were injected with anesthetic and then studied using discography and CT examination. In addition, patients were asked to perform maneuvers that would typically elicit their pain symptoms. Nineteen of the 29 (65.5%) injected discs showed a favorable response (pain relief greater than 3 visual analog pain scale units) compared with ten (34.5%) injected discs that did not show a favorable response. In those patients with a favorable FAD response, 19 discs showed a provocative response during discography and 18 discs showed the presence of disc pathology on CT examination. In patients with an unfavorable FAD response, 8 discs showed a provocative discographic response, and 6 discs showed the presence of disc pathology on CT examination.The authors cautioned that even though FAD seemed to work in some cases, it often actually raised more questions as to diagnosis.
Professional Societies and Organizations American College of Radiology (ACR): Appropriateness Criteria for Evaluation of Patients with Acute Low Back Pain-Radiculopathy: Discography is not warranted in view of the efficacy of other less invasive imaging procedures. The discography may be helpful when other procedures fail to localize the pain because the injection itself may reproduce the patient's pain and aid in diagnosis.
(Bradley, 2005) Congress of Neurological Surgeons: In the 2005 guideline published regarding magnetic resonance imaging and discography for patient selection for lumbar fusion, Resnick et al. state that discography is a sensitive but non specific diagnostic test for the diagnosis of discogenic low-back pain. The restriction of the definition of a positive discographic study to one that elicits concordant pain from a morphologically abnormal disc improves the definition's accuracy. Fusion surgery based on discography alone, however, is not reliably associated with clinical success. Therefore, discography is not recommended as a standalone test for treatment decisions in patients with low-back pain.
Magnetic resonance imaging is a sensitive and noninvasive test for the presence of degenerative disc disease. Discography should not be attempted in patients with normal lumbar MR images.
Discography appears to have a role in the evaluation of patients with low-back pain, but it is best limited to the evaluation of abnormal interspaces identified on MR imaging, the investigation of adjacent-level disc disease, and as a means to rule out cases of nonorganic pain from surgical consideration. (Resnick, 2005) North American Spine Society (NASS): In 1995 the NASS published a position statement regarding discography. According to the position statement, this procedure is indicated for patients with persistent pain in whom disc abnormality is suspect, but noninvasive tests have not provided sufficient diagnostic information or the images need to be correlated with clinical symptoms. It is also recommended for the assessment of discs in patients considering lumbar fusion, who have previously undergone surgery but continue to experience significant pain, and to confirm contained disc herniation. (Guyer, 1995) Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline In 2003 NASS conducted a comprehensive literature review of lumbar discography to update the 1995 position statement on discography Their review concluded that most of the literature does support the use of discography in selected patients. Several authors evaluated in the review compared discography to myelography, CT and MRI. Compared to myelography, the authors report that literature supports discography as more accurate based on surgical confirmation of findings. When compared to CT, discography was shown to provide essential information. Reports comparing discography to MRI provided variable conclusions. Some authors reported MRI to be as good as discogram while others identified abnormal discography in patients with normal or equivocal MRI.
NASS further concluded that discography is indicated for the following conditions (Guyer, 2003):