Effective Date: 7/1/2018 Section: MED Policy No: 123 Medical Officer 7/1/18 Date Technology Assessment Committee Approved Date: 10/10; 12/15 Medical Policy Committee Approved Date: 8/94; 7/96; 8/97; 4/98; 4/99; 4/00; 8/01; 12/02; 2/03; 8/03; 7/04; 7/06; 9/08; 10/10; 11/12;1/13; 10/14; 11/2014; 1/15; 3/15; 4/15; 9/15; 9/16; 6/17; 6/18 APPLIES TO: See Policy CPT/HCPCS CODE section below for any prior authorization requirements All lines of business except Medicare BENEFIT APPLICATION Medicaid Members Oregon: Services requested for Oregon Health Plan (OHP) members follow the OHP Prioritized List and Oregon Administrative Rules (OARs) for coverage determinations. For other lines of business, refer to the Policy Criteria section below: CRITERIA I. Epidural steroid injections may be considered medically necessary and covered as a treatment of back or neck pain when all of the following criteria (A.-C.) are met: A. A maximum of 3 injections per spinal region (cervical, thoracic, or lumbar) may be allowed per year, with 4 weeks between injections. Approval of subsequent injections is dependent on the success of the initial injections; and B. There must be recent MRI and/or CT imaging documenting severe foraminal stenosis or disc protrusion with nerve impingement resulting in radicular pain. There must be a corresponding dermatomal distribution of the pain. The injection must be targeted to documented impingement; and C. There must be a failure of less invasive interventions for persistent pain or for avoiding surgery including physical therapy and/or chiropractic care and at least one of the following within the last 6 months: 1. Medications such as: narcotic analgesics, muscle relaxants, non-steroidal antiinflammatory drugs; or 2. Interdisciplinary pain management program with physical therapy if available. Page 1 of 6
Note: Neither conscious sedation nor Monitored Anesthesia Care (MAC) is routinely necessary for epidural steroid injections and are not routinely reimbursable. Individual consideration may be given for payment in rare unique circumstances if the medical necessity of sedation is unequivocal and clearly documented. II. Epidural steroid injections are considered experimental/investigational and are not covered as a treatment of central spinal stenosis. III. Caudal epidural steroid injections are considered experimental/investigational and are not covered as a treatment of back pain. BILLING GUIDELINES Convenience kits, such as Dyural 80, are not covered. Physicians are to bill for the steroid medication only. All other costs are procedural expenses. Epidural steroid injections using ultrasound guidance is not covered. Therefore, ESI may not be billed using codes 0228T-0231T. CPT/HCPCS CODES All Lines of Business Except Medicare Prior Authorization Required 62320 Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance 62321 Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; with imaging guidance (ie, fluoroscopy or CT) 62322 Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging guidance 62323 Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); with imaging guidance (ie, fluoroscopy or CT) 64479 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level 64480 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging Page 2 of 6
guidance (fluoroscopy or CT); cervical or thoracic, each additional level (List separately in addition to code for primary procedure) 64483 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level 64484 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level (List separately in addition to code for primary procedure) Unlisted Codes All unlisted codes will be reviewed for medical necessity, correct coding, and pricing at the claim level. If an unlisted code is billed related to services addressed in this policy then prior-authorization is required. J3490 Unclassified drugs DESCRIPTION Epidural Injection involves the placement of saline, anesthetic or steroids into the epidural space to decrease lower back pain or neck pain associated with radicular symptoms. Local anesthetic injections have also been proposed to diagnose and locate the source of spinal pain. In addition, the use of steroid injections has been suggested as a treatment of refractory nerve root irritation from impingement due to an extruding or bulging disc. REVIEW OF EVIDENCE A review of the ECRI, Hayes, Cochrane, and PubMed databases was conducted regarding the use of epidural steroid injection (ESI) as a diagnostic tool or treatment for back and neck pain. Below is a summary of the available evidence identified through July of 2016: ESI for Cervical Radiculopathy The 2016 Hayes report regarding cervical radiculopathy indicated the evidence does not support any beneficial effect of epidural steroids. 1 The benefit may be from the anesthetic administered with the steroids. Hayes indicated that the quality of evidence was low to moderate based on the lack of double blinding, small study sizes, and limited follow up periods. None of the studies included placebo comparison groups. There was also limited consistency in the types of injection procedures used. ESI for Low Back Pain and Sciatica The 2016 Hayes report regarding epidural steroid injections to treat low back pain and sciatica indicated ESI may offer temporary pain relief; however, it is unclear if treatment effect may be attributed to the anesthetic administered with the steroids or the steroids themselves. 2 Hayes indicated that the quality of evidence was low to moderate due to small study sample sizes and limited follow-up; thus making it difficult to assess efficacy. ESI for Central Spinal Stenosis Page 3 of 6
Per Hayes archived report in 2015 there was sufficient evidence to evaluate the use of ESI for the treatment of central spinal stenosis, but the evidence presented conflicting findings as to the efficacy of this treatment. 3 Due to mixed study results, conclusions regarding safety and efficacy could not be made; therefore, it is considered experimental and investigational. Caudal Injections The 2016 Hayes report regarding epidural steroid injections to treat low back pain and sciatica indicated that transforaminal injections appear to provide better relief of pain than caudal injections in both the long and short term studies. 2 Other studies reviewed agreed with this conclusion. 4-7 The largest study reviewed included 240 patients followed over a 24 month period. EVIDENCE SUMMARY Although there is limited evidence regarding the use of epidural steroid injections as a treatment for cervical radiculopathy, low back pain, and sciatica, they have become a standard of care treatment for these conditions. Larger, randomized controlled trials are needed to examine the caudal approach for epidurals and determine if they provide better relief of pain and decreased side effects compared to transforaminal injections. CLINICAL PRACTICE GUIDELINES Colorado Division of Workers Compensation The 2014 Colorado Division of Workers Compensation evidence-based clinical practice guideline for low back pain medical treatment stated there is strong evidence that epidural steroid injections have a small average short term benefit for leg pain and disability for those with sciatica. 8 The guideline also concluded there is good evidence that the addition of steroids to a transforaminal injection has a small effect on patient reported pain and disability. Lastly, the guideline stated there is strong evidence that epidural steroid injections do not, on average, provide clinically meaningful long-term improvements in leg pain, back pain, or disability in patients with sciatica (lumbar radicular pain or radiculopathy). 8 North American Spine Society (NASS) The 2012 NASS evidence-based clinical practice guideline on the diagnosis and treatment of cervical radiculopathy from degenerative disorders recommended transforaminal epidural steroid injections for short term (2-4 weeks) relief of pain from lumbar disc herniation with radiculopathy. 9 The NASS indicated that there was insufficient evidence to make a recommendation about the efficacy in pain relief over a 12 month time frame, although it was also indicated that there is evidence that suggests ESI injections improve functional outcomes in a majority of patients. The NASS guidelines indicated there was no evidence to determine the effectiveness of one injection approach (interlaminar, transforaminal or caudal) over another. 9 Page 4 of 6
Institute for Clinical Systems Improvement (ICSI) The 1994 (Updated 2012) ICSI evidence-based clinical practice guideline for adult acute and subacute low back pain recommended the following: 10 Epidural steroid injections may be used for acute low back pain with a radicular component to assist with short-term pain relief (Weak Recommendation, Moderate Quality Evidence) Epidural steroid injections should only be considered after an initial appropriate conservative treatment program It is a matter of clinical judgement for determining how long to wait before offering an epidural steroid injection (i.e., in cases of severe symptoms, injections are often performed earlier in the treatment course) Epidural steroid injections should not be used as a monotherapy Patients should be made aware of the risks of short- or long-term steroid use INSTRUCTIONS FOR USE Providence Health Plan (PHP) Medical Policies serve as guidance for the administration of plan benefits. Medical policies do not constitute medical advice nor a guarantee of coverage. PHP Medical Policies are reviewed annually and are based upon published, peer-reviewed scientific evidence and evidence-based clinical practice guidelines that are available as of the last policy update. PHP reserve the right to determine the application of Medical Policies and make revisions to its Medical Policies at any time. Providers will be given at least 60-days notice of policy changes that are restrictive in nature. The scope and availability of all plan benefits are determined in accordance with the applicable coverage agreement. Any conflict or variance between the terms of the coverage agreement and PHP Medical Policy will be resolved in favor of the coverage agreement. REGULATORY STATUS Mental Health Parity Statement Coverage decisions are made on the basis of individualized determinations of medical necessity and the experimental or investigational character of the treatment in the individual case. REFERENCES 1. Hayes Medical Technology Directory: Epidural Steroid Injections for Cervical Radiculopathy. 2013; https://www.hayesinc.com/subscribers/displaysubscriberarticle.do?articleid=15639&searchsto re=%24search_type%3dall%24icd%3d%24keywords%3depidural%2csteroid%2cinjection%24sta tus%3dactive%24page%3d1%24from_date%3d%24to_date%3d%24report_type_options%3d% Page 5 of 6
24technology_type_options%3D%24organ_system_options%3D%24specialty_options%3D%24o rder%3dasearchrelevance. Accessed 6/6/2017. 2. National Guideline C. Clinical guideline: management of gastroparesis. 2013. 3. Centers for Medicare & Medicaid Services Local Coverage Determination: Lumbar Epidural Injections (L34980). 2015; https://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=34980&ver=10&searchtype=advanced&coverageselection=both&ncselecti on=nca%7ccal%7cncd%7cmedcac%7cta%7cmcd&articletype=sad%7ced&policytype=both &s=44&keyword=epidural&keywordlookup=doc&keywordsearchtype=exact&kq=true&bc=ia AAACAAAAAAAA%3d%3d&. Accessed 6/6/2017. 4. Kamble PC, Sharma A, Singh V, Natraj B, Devani D, Khapane V. Outcome of single level disc prolapse treated with transforaminal steroid versus epidural steroid versus caudal steroids. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2016;25(1):217-221. 5. Manchikanti L, Falco FJ, Pampati V, Hirsch JA. Lumbar interlaminar epidural injections are superior to caudal epidural injections in managing lumbar central spinal stenosis. Pain physician. 2014;17(6):E691-702. 6. Manchikanti L, Pampati V, Benyamin RM, Boswell MV. Analysis of efficacy differences between caudal and lumbar interlaminar epidural injections in chronic lumbar axial discogenic pain: local anesthetic alone vs. local combined with steroids. International journal of medical sciences. 2015;12(3):214-222. 7. Ploumis A, Christodoulou P, Wood KB, Varvarousis D, Sarni JL, Beris A. Caudal vs transforaminal epidural steroid injections as short-term (6 months) pain relief in lumbar spinal stenosis patients with sciatica. Pain medicine (Malden, Mass). 2014;15(3):379-385. 8. Colorado Division of Workers' Compensation: Low Back Pain Medical Treatment Guidelines. 2014; https://www.guideline.gov/summaries/summary/49020/low-back-pain-medicaltreatment-guidelines?q=epidural+steroid+injection. Accessed 6/6/2017. 9. Bono CM, Ghiselli G, Gilbert TJ, et al. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. The spine journal : official journal of the North American Spine Society. 2011;11(1):64-72. 10. Institute for Clinical Systems Improvement: Adult Acute and Subacute Low Back Pain. 1994 (Revised 2012); https://www.guideline.gov/summaries/summary/39319/adult-acute-andsubacute-low-back-pain?q=epidural+steroid+injection. Accessed 6/6/2017. Page 6 of 6