Clinical Policy Title: Discography

Transcription

1 Clinical Policy Title: Discography Clinical Policy Number: Effective Date: January 1, 2017 Initial Review Date: October 19, 2016 Most Recent Review Date: October 19, 2017 Next Review Date: October 2018 Policy contains: Provocative discography Related policies: CP# CP# CP# CP# CP# Spinal cord stimulators for chronic pain Radiofrequency ablation treatment for spine pain Spinal surgeries Spine pain facet joint injections Spine pain trigger point injections ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas considers the use of discography to be investigational and, therefore, not medically necessary (Xi 2016, Kim 2015, Hayes 2014, Manchikanti 2013, Onyewu 2012, Singh 2012, Lopez 2012). Limitations: AmeriHealth Caritas considers all other uses of discography to be investigational and, therefore, not medically necessary. Alternative covered services: Primary care and specialty physician (including surgical) evaluation and management

2 Background Discography is a diagnostic radiology test in which contrast is injected under fluoroscopy into the nucleus of a disc thought to be the cause of a patient's low back (or other spinal) pain, with a positive test based on the replication of the patient s pain (termed concordant pain). Its reliability is controversial because of the absence of a clearly defined gold-standard reference test and false positive results in patients without spinal back pain. Searches AmeriHealth Caritas searched PubMed and the databases of: UK National Health Services Center for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on September 19, Searched terms were: " discogram (MeSH)"," provocative discography (MeSH)" and "concordant pain." We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Deyo (2004) writing in a seminal article published in the New England Journal of Medicine about the rising use of spinal fusion surgery in American concluded that discography is unreliable especially when it is used to determine which patients are to receive spinal fusion, a procedure that is associated with an impressively high complication rate, widespread abuse, and high cost. Carragee (2005) classically described the attempts that have been made to use provocative injections and anesthetic blockade as tests to identify a primary symptomatic structure or pain generator. The tests involve injecting dye or local anesthetic into the intervertebral disc as a preoperative measure to direct invasive therapy. Proponents suggest that if injection into the disc reproduces a patient s usual low back pain, then that disc must be the cause of the pain. However, injection can simulate the quality 2

3 and location of pain known not to originate from that disc. Further, injections are painful 30 to 80 percent of the time for patients who do not have symptomatic disc disease but who have had 1.) previous disc surgery or psychogenic distress, 2.) remote chronic pain or 3.) disputed compensation claims. Outcomes of spinal fusion with discography which was or was not used in the preoperative evaluation showed no differences between the two groups. Carragee (2006) laid another cornerstone when he renewed his criticism of discography in an assessment of surgical treatment for primary back pain associated with disc changes (discogenic pain) in a narrative review that found randomized trials of lumbar fusion compared with various nonsurgical strategies showed neither consistently good outcomes with surgery nor clear benefit over nonsurgical treatment Lopez (2012) in a retrospective cohort study of 20 patients and 33 discographies used magnetic resonance imaging (MRI) findings to evaluate degenerative disc disease. All examinations were performed in the lumbar spine between L3 and S1. Fourteen discographies (42 percent) were positive and 19 (58 percent) were negative. Patients with lower back pain alone had reduced odds of a positive discography compared with those with lower back pain and sciatica (OR =.5; 95 percent CI: ); however, this association was not statistically significant. Patients with more than four previous episodes of pain versus patients with one to four episodes had greater odds of a positive discography (OR = 3.8; 95 percent CI: ); but this association was not statistically significant. Patients with various pathologies on MRI had greater odds of a positive discography; however, these associations were not statistically significant. The authors concluded that patients with a chief complaint of lower back pain associated with sciatica, with more than four episodes of previous lower back pain exacerbations and the presence of a high intensity zone on MRI have a higher rate of positive discography. These findings are not statistically significant due to a small sample size. Singh (2012) assessed two clinical studies evaluating the diagnostic accuracy of provocative thoracic discography with respect to chronic, function limiting, thoracic or extra-thoracic pain. The authors concluded that based on limited evidence, thoracic provocation discography is rarely indicated for the diagnosis of discogenic pain in the thoracic spine. Onyewu (2012) in a systematic review of 41 randomized controlled trials evaluated the diagnostic accuracy of cervical discography for chronic neck pain. The authors concluded that there is limited evidence for the diagnostic accuracy of cervical discography; however, in the absence of any other means to establish a relationship between pathology and symptoms, cervical provocation discography may be an important evaluation tool in certain contexts (e.g., as an affirmative test where a radiologic or clinical assessment suggests discogenic pain) to identify a subset of patients with chronic neck pain secondary to intervertebral disc disorders. The authors also suggested that cervical discography may help prevent unnecessary surgical intervention. Manchikanti (2013) conducted a systematic review of 160 randomized controlled trials to assess the diagnostic accuracy of lumbar provocative discography. Of these, 33 studies compared discography with 3

4 other diagnostic tests, 30 studies assessed the diagnostic accuracy of discography, 22 studies assessed surgical outcomes for discogenic pain, and 3 studies assessed the prevalence of lumbar discogenic pain. The quality of the overall evidence supporting the use of provocation discography was adjudged to be fair. The authors concluded that discography may be a useful tool for evaluating chronic lumbar discogenic pain. Hayes (2014) indicated that lumbar discography can result in high false-positive rates in identifying painproducing discs, although pressure-controlled injection and strict classification of results can reduce the false-positive rate to 10 percent. When surgical outcome was used as the reference standard, some studies found a high degree of correlation between discography findings and degree of pain relief following surgery, while others failed to find any contribution of discography to surgical outcome. Inconsistencies among studies may relate to the variable results of these surgical approaches and/or to differences in discography protocol. In the only study comparing discography with an alternate diagnostic approach, outcome after spinal fusion was worse in patients undergoing discography than in patients undergoing discoblock (intradiscal anesthesia); however, the source of pain differed in the discography and discoblock groups. Hayes concluded that available data do not clearly establish the efficacy of lumbar discography or the comparable value of lumbar discography relative to other methods in identifying the source of low back pain or determining surgical candidacy, nor do they clarify whether a positive discogram is sufficient to warrant surgery, particularly when using updated standards for defining positive discograms. The evidence does suggest that lumbar discography, as currently performed, is not commonly associated with serious adverse effects. Hayes assigned the following ratings of efficacy for discography: C for potential but unproven benefit in that some published evidence suggests that safety and impact on health outcomes are at least comparable to standard treatment/testing. However, substantial uncertainty remains about safety and/or impact on health outcomes because of poor-quality studies, sparse data, conflicting study results, and/or other concerns. C minus for lumbar discography using pressure-controlled injection and updated criteria for positive discograms in patients with chronic severe low back pain who are potential candidates for spinal surgery, when conservative care has failed, and other diagnostic tests have not clearly confirmed a suspected disc as the source of pain. D for no proven benefit, with a note that published evidence shows that the technology does not improve health outcomes or patient management for the reviewed application(s) or is unsafe; and there is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management. 4

5 D minus for lumbar discography in patients who have a contraindication to the procedure in acknowledgment to concerns regarding the safety of the procedure in these patients. Kim (2015) studied 72 patients with chronic (>6 months) low back pain refractory to medical therapy and a total of 183 intervertebral discs with discography performed using a pressure-controlled manometric technique. The pain reaction during discography at each level was recorded as follows: no pain, dissimilar pain, similar pain, or concordant pain. Discs with similar or concordant pain were classified as positive. Higher general degeneration and annular disruption grades also had higher positive rates of discography; however, annular disruption alone was independently associated with positive discography. The grade of general degeneration was associated with age, but it was not correlated with positive discography and prognosis. In addition, a high grade of annular disruption correlated with positive discography. Xi (2016) studied the efficacy of discography combined with computerized tomography (CT) in identifying surgical candidates for lumbar fusion. Forty-three consecutive patients between 2006 and 2013 who presented with refractory low back pain and underwent discography and CT were enrolled in the study. Concordant pain with discography was reported by 9 (20.9 percent) patients at L3-L4, 21 (50.0 percent) at L4-L5, and 34 (82.9 percent) at L5-S1. Pain occurred significantly more often in discs where CT identified annular tears than those without (p<0.001). The authors concluded that lumbar discography and CT can be an effective method to evaluate patients with discogenic back pain refractory to non-operative treatments. Those patients with one- or two-level high concordant pain scores with associated annular tears and a negative control disc study represent good surgical candidates for lumbar interbody spinal fusion. Burnham (2016) offers that in the eyes of some consultants discography is considered a marker for overuse of spinal procedures. He adds that Manchikanti s review of discography is an interesting read, in that he takes a very negative meta-analysis and looks at it through rose-colored glasses. Policy updates: None. Summary of clinical evidence: Citation Xi (2016) Using Provocative Discography and Computed Tomography to Select Patients with Refractory Content, Method, Recommendations Studied the efficacy of discography combined with CT in assessing 43 surgical candidates for lumbar fusion. Concordant pain with discography was reported by 9 (20.9%) patients at L3-L4, 21 (50.0%) at L4-L5, and 34 (82.9%) at L5-S1. Pain occurred significantly more often in discs where CT identified annular tears than those without (p<0.001). 5

6 Citation Discogenic Low Back Pain Kim (2015) Content, Method, Recommendations The authors concluded that lumbar discography and CT can be an effective method to evaluate patients with discogenic back pain refractory to non-operative treatments. Analysis of the Correlation Among Age, Disc Morphology, Positive Discography and Prognosis Hayes (2014) Studied 72 patients with chronic (>6 months) low back pain refractory to medical therapy Total of 183 intervertebral discs evaluated with discography performed using a pressure-controlled manometric technique and CT of the involved spine. Discs with similar or concordant pain were classified as positive. Higher general degeneration and annular disruption grades had higher positive rates of discography; however, annular disruption alone was independently associated with positive discography. The grade of general degeneration was associated with age, but it was not correlated with positive discography and prognosis. A high grade of annular disruption correlated with positive discography. Discography for diagnosis of low back pain Manchikanti (2013) An update of the systematic appraisal of the accuracy and utility of lumbar discography Onyewu (2012) C for lumbar discography safety o Evidence suggests that safety is at least comparable to standard treatment/testing. C minus for lumbar discography for diagnosis o Constrained to pressure-controlled injection and updated criteria for positive discograms D for no proven benefit of lumbar discography in health outcomes or management of disease o Evidence shows that the technology does not improve health outcomes or patient management o Has potential but as yet unproven benefit D minus for lumbar discography in patients who have a contraindication to the procedure. Systematic review of 160 randomized controlled trials to assess the diagnostic accuracy of lumbar provocation and analgesic discography. Of these, 33 studies compared discography with other diagnostic tests, 30 studies assessed the diagnostic accuracy of discography, 22 studies assessed surgical outcomes for discogenic pain, and 3 studies assessed the prevalence of lumbar discogenic pain. The authors concluded that discography may be a useful tool for evaluating chronic lumbar discogenic pain. The quality of the overall evidence supporting the use of provocation discography was adjudged to be fair. An update of the appraisal of the accuracy and utility of cervical discography in chronic neck pain Systematic review of 41 randomized controlled trials evaluated the diagnostic accuracy of cervical discography for chronic neck pain. The authors concluded that there is limited evidence for the diagnostic accuracy of cervical discography Cervical provocation discography may be an important evaluation tool in certain contexts (e.g., as an affirmative test where a radiologic or clinical assessment suggests discogenic pain) The authors suggested that cervical discography may help prevent unnecessary surgical intervention. 6

7 Citation Singh (2012) An update of the appraisal of the accuracy of thoracic discography as a diagnostic test Lopez (2012) Clinical and radiological association with positive lumbar discography Carragee (2006) Persistent Surgical Treatment of Lumbar Disk Disorders Carragee (2005) Persistent Low Back Pain Deyo (2004) Content, Method, Recommendations Review of two clinical studies evaluating the diagnostic accuracy of provocative thoracic discography The authors concluded that based on limited evidence, thoracic provocation discography is rarely indicated for the diagnosis of discogenic pain in the thoracic spine. Retrospective cohort study of 20 patients and 33 discographies used MRI findings to evaluate DDD. Fourteen discographies (42 %) were positive and 19 (58 %) were negative. Patients with lower back pain alone had reduced odds of a positive discography compared with those with lower back pain and sciatica (OR =.5; 95 % CI: ) Patients with more than four previous episodes of pain versus patients with one to four episodes had greater odds of a positive discography (OR = 3.8; 95 % CI: ) Patients with various pathologies on MRI had greater odds of a positive discography. The authors concluded that patients with a chief complaint of lower back pain associated with sciatica, with more than four episodes of previous lower back pain exacerbations and the presence of a high intensity zone on MRI have a higher rate of positive discography. Renewed criticism of discography in an assessment of surgical treatment for primary back pain associated with disc changes (discogenic pain). Found randomized trials of lumbar fusion compared with various nonsurgical strategies showed neither consistently good outcomes with surgery nor clear benefit over nonsurgical treatment Assessed provocative injections and anesthetic blockade to identify a primary symptomatic structure or pain generator. Used to direct invasive therapy proponents suggest that if injection into the disk reproduces a patient s usual low back pain then that disk must be the cause of the pain. However, injection can simulate the quality and location of pain known now to original from that disc. Injections are painful 30 80% of the time for patients who do not have symptomatic disc disease but who have had: o Previous disk surgery or psychogenic distress o Remote chronic pain o Disputed compensation claims. Outcomes of spinal fusion with discography in which the test was or was not used in the preoperative evaluation showed no differences between groups. Spinal-Fusion Surgery Concluded that discography is unreliable especially when it is used to determine which patients are to receive spinal fusion Associated with an impressively high complication rate, widespread abuse, and high cost. References Professional society guidelines/other: 7

8 Hayes Inc., Hayes Medical Directory Report. Discography for diagnosis of low back pain. Lansdale, Pa. Hayes Inc.; March, Newman JS, Weissman BN, Angevine PD, et. al. Expert Panel on Musculoskeletal Imaging. ACR Appropriateness Criteria chronic neck pain. Reston (VA): American College of Radiology (ACR); Patel ND, Broderick DF, Burns J, et. al., American College of Radiology (ACR) Expert Panel on Neurologic Imaging. ACR Appropriateness Criteria low back pain. Reston (VA): American College of Radiology (ACR); Personal correspondence: William Burnham MD FAAFP CPE. Regional UM Medical Director, Region 1; AmeriHealth Caritas Family of Companies. Charleston, SC. Peer-reviewed references: Carragee E. Persistent Low Back Pain. NEJM. 2005;352(18): Carragee E. Persistent Surgical Treatment of Lumbar Disk Disorders. JAMA. 2006;296(20): Deyo R, Nachemson A, Mirza S. Spinal-Fusion Surgery The Case for Restraint. NEJM. 2004;350(7): Kim S-M, Lee S-H, Lee B-R, Hwang J-W. Analysis of the Correlation Among Age, Disc Morphology, Positive Discography and Prognosis in Patients With Chronic Low Back Pain. Annals of Rehabilitation Medicine. 2015;39(3): López WO, Vialle EN, Anillo CC, et. al. Clinical and radiological association with positive lumbar discography in patients with chronic low back pain. Evid Based Spine Care J. 2012;3(1): Manchikanti L, Benyamin RM, Singh V, et. al. An update of the systematic appraisal of the accuracy and utility of lumbar discography in chronic low back pain. Pain Physician. 2013;16(2 Suppl):SE Onyewu O, Manchikanti L, Falco FJ, et al. An update of the appraisal of the accuracy and utility of cervical discography in chronic neck pain. Pain Physician. 2012;15(6):E777-E806. Singh V, Manchikanti L, Onyewu O, et al. An update of the appraisal of the accuracy of thoracic discography as a diagnostic test for chronic spinal pain. Pain Physician. 2012;15(6):E757-E775. Xi MA, Tong HC, Fahim DK, Perez-Cruet M. Using Provocative Discography and Computed Tomography to Select Patients with Refractory Discogenic Low Back Pain for Lumbar Fusion Surgery. Muacevic A, Adler JR, eds. Cureus. 2016;8(2):e514. 8

9 CMS National Coverage Determination (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals. CPT Code Description Comment Injection procedure for discography, each level; lumbar Injection procedure for discography, each level; cervical or thoracic Discography, cervical or thoracic, radiological supervision and interpretation Discography, lumbar, radiological supervision and interpretation ICD-10 Code Description Comment M54.2 Cervicalgia M M54.42 Lumbago with sciatica M54.5 Low back pain M54.6 Pain in thoracic spine M54.9 Dorsalgia HCPCS Level II Code N/A Description Comment 9