GENERAL INFORMATION 
It is an expectation that all patients receive care/services from a licensed clinician. All appropriate supporting documentation, including recent pertinent office visit notes, laboratory data, and results of any special testing must be provided.  If applicable: All prior relevant imaging results and the reason that alternative imaging cannot be performed must be included in the documentation submitted.   

Policy 
Note: Any injection performed at least two years from prior injections in the same region will be considered a new episode of care and the INITIAL injection requirements must be met for approval. Events such as surgery on the same spinal region or any new pathology would also prompt a new episode of care.

INDICATIONS FOR EPIDURAL SPINE INJECTIONS OR SELECTIVE NERVE BLOCKS (Caudal, Interlaminar, Transforaminal) 

For the treatment of acute pain or exacerbation of chronic radicular pain1 ALL of the following must be met:

• Neck or back pain with acute radicular symptoms²
• Pain causing functional disability or average pain level of ≥ 6 on a scale of 0 to 10^2,3,4,5
• Duration of pain < 3 months
• Failure to respond to non-operative conservative therapy targeting the requested spinal region for a minimum of 2 weeks unless the medical reason this treatment cannot be done is clearly documented (active therapy components not required)^2,3

For the treatment of spinal stenosis causing axial or radicular pain1 ALL of the following must be met:

• Pain causing functional disability or average pain level of ≥ 6 on a scale of 0 to 10 ^2,3,4,5
• Failure to respond to non-operative conservative therapy* targeting the requested spinal region for a minimum of 6 weeks in the last 6 months unless the medical reason this treatment cannot be done is clearly documented; OR details of engagement in ongoing non-operative conservative therapy* if the individual has had prior spinal injections in the same region^2,3 

For the treatment of failed back surgery syndrome or epidural fibrosis causing axial^6,7 or radicular pain¹ ALL of the following must be met:

• Pain causing functional disability or average pain level of ≥ 6 on a scale of 0 to 10^2,3,4,5
• Documentation of a medical reason that clearly indicates why an injection is needed (not typically done immediately post-surgery)³
• Failure to respond to non-operative conservative therapy* targeting the requested spinal region for a minimum of 6 weeks in the last 6 months unless the medical reason this treatment cannot be done is clearly documented; OR details of engagement in ongoing non-operative conservative therapy* if the individual has had prior spinal injections in the same region^2,3 

For a diagnostic transforaminal injection to identify the pain generator for surgical planning ALL of the following must be met:

• Pain causing functional disability or average pain level of ≥ 6 on a scale of 0 to 10^2,3,4,5
• Documentation of a pre-operative evaluation and plan for surgery

NOTE: No more than 2 levels of transforaminal blocks should be done in one day.⁸ 

INDICATIONS FOR REPEAT INJECTIONS 
Epidural injections may be repeated only considered MEDICALLY NECESSARY. Each epidural injection requires an authorization, and the following criteria must be met for repeat injections:

• Up to 3 epidural injections may be performed in the initial treatment phase, no sooner than 2 weeks apart, provided that at least 30% pain relief or significant documented functional improvement is obtained⁵ 
• If an injection during the initial treatment phase is unsuccessful, another injection may be performed at a different level in the same spinal region or with a change in technique given there is a question about the pain generator or evidence of multi-level pathology
• Epidural injections may only be repeated after the initial treatment phase if the individual has had at least 50% pain relief or significant documented functional improvement for a minimum of 2 months after each therapeutic injection³
• The individual continues to have pain causing functional disability or average pain level ≥ 6 on a scale of 0 to 10^2,3,5 
• The individual is engaged in ongoing active conservative therapy*, unless the medical reason this treatment cannot be done is clearly documented^{2, 9}
• In the first year of treatment, a total of 6 epidural injections may be performed per spinal region (this includes a series of 3 injections in the initial treatment phase and 3 additional therapeutic injections).³
• After the first year of treatment, a maximum of 4 epidural injections may be performed in a 12-month period per spinal region.^3,5 If special circumstances are documented (e.g., elderly individual with severe spinal stenosis and not an operative candidate), then repeat injections are limited to a maximum of 6 epidural injections in a 12-month period per spinal region.⁵
• If different spinal regions are being treated, injections should be administered at intervals of no sooner than 7 days unless a medical reason is provided to necessitate injecting multiple regions on the same date of service (see NOTE).³

NOTE: It is generally considered NOT MEDICALLY NECESSARY to perform multiple interventional pain procedures on the same date of service. Documentation of a medical reason to perform injections in different regions on the same day can be provided and will be considered on a case-by-case basis (e.g., holding anticoagulation therapy on two separate dates creates undue risk for the patient). Different types of injections in the same spinal region (cervical, thoracic, or lumbar) should not be done on the same day with the exception of a facet injection and ESI performed during the same session for a synovial cyst confirmed on imaging.

EXCLUSIONS
These requests are excluded from consideration under this guideline:

• Intrathecal injections for pain or spasticity prior to permanent pump insertion
• Implantation of intrathecal catheters or ports for chemotherapy
• Post-operative pain control
• Caudal or spinal anesthesia for surgery

CONTRAINDICATIONS FOR EPIDURAL INJECTIONS

• Active systemic or spinal infection
• Skin infection at the site of needle puncture
• Severe spinal stenosis resulting in intraspinal obstruction

Rationale
Therapeutic Spinal Epidural Injections or Select Nerve Root Blocks (Transforaminal) are types of interventional pain management procedures. The therapeutic use of epidural injections is for short-term pain relief associated with acute back pain or exacerbation of chronic back pain. With therapeutic injections, a corticosteroid is injected close to the target area with the goal of pain reduction. Epidural injections should be used in combination with other active conservative treatment* modalities and not as stand-alone treatment for long-term back pain relief. Different approaches used when administering spinal epidural injections13 include: 

• Interlaminar epidural injections, with steroids, access the epidural space between two vertebrae (Interlaminar) to treat cervical, lumbar, or thoracic pain with radicular pain.¹⁴ These procedures should be performed using fluoroscopic guidance.^15,16 Interlaminar epidural injections are the most common type of epidural injection.
• Transforaminal epidural injections (also called selective nerve root blocks) access the epidural space via the intervertebral foramen where the spinal nerves exit (cervical, lumbar/sacral, or thoracic region). It is used both diagnostically and therapeutically. Some studies report lack of evidence and risks of transforaminal epidural injections.¹⁷  These procedures are always aided with fluoroscopic guidance.^{1,16,18,19,20,21} 
• Caudal epidural injections, with steroids, are used to treat back and lower extremity pain, accessing the epidural space through the sacral hiatus, providing access to the lower nerve roots of the spine. These procedures should be performed using fluoroscopic guidance. Failed back surgery syndrome is the most common reason for the caudal approach.^{3,16,21,22,23} 

The rationale for the use of spinal epidural injections is that the sources of spinal pain, e.g., discs and joints, are accessible and amendable to neural blockade. 

Medical necessity management for epidural injections includes an initial evaluation including history and physical examination as well as a psychosocial and functional assessment. The following must be determined: nature of the suspected organic problem; non-responsiveness to active conservative treatment*; level of pain and functional disability; conditions which may be contraindications to epidural injections; and responsiveness to prior interventions.

Interventional pain management specialists do not agree on how to diagnose and manage spinal pain; there is a lack of consensus with regards to the type and frequency of spinal interventional techniques for treatment of spinal pain. The American Society of Interventional Pain Physicians (ASIPP) guidelines recommend an algorithmic approach which provides a step-by-step procedure for managing chronic spinal pain based upon evidence-based guidelines.^1,3 This approach is based on the structural basis of spinal pain and incorporates acceptable evidence of diagnostic and therapeutic interventional techniques available in managing chronic spinal pain. 

The guidelines and algorithmic approach referred to above include the evaluation of evidence for diagnostic and therapeutic procedures in managing chronic spinal pain and recommendations for managing spinal pain. The indications and contraindications presented within this document are based on the guidelines and algorithmic approach. Prior to performing this procedure, shared decision-making between patient and physician must occur, and the patient must understand the procedure and its potential risks and results (moderate short-term benefits, and lack of long-term benefits).

OVERVIEW

*Conservative Therapy: Non-operative treatment should include a multimodality approach consisting of a combination of active and inactive components. Inactive components can include rest, ice, heat, modified activities, medical devices, acupuncture, stimulators, medications, injections, and diathermy. Active modalities should be region-specific (targeting the cervical, thoracic, or lumbar spine) and consist of physical therapy, a physician-supervised home exercise program**, or chiropractic care.^2,9,24

**Home Exercise Program (HEP): The following two elements are required to meet guidelines for completion of conservative therapy: 

• Documentation of an exercise prescription/plan provided by a physician, physical therapist, or chiropractor^9,25,26 ; AND
• Follow-up documentation regarding completion of HEP after the required 6-week timeframe or inability to complete HEP due to a documented medical reason (i.e., increased pain or inability to physically perform exercises). Closure of medical offices, closure of therapy offices, patient inconvenience, or noncompliance without explanation does not constitute “inability to complete” HEP.^2,9

Terminology - Interlaminar Epidural; Selective Nerve Root Injection (transforaminal only); Transforaminal Injection; Injections of Spinal Canal

Hip-spine syndrome^27,28,29: Hip-spine syndrome is a condition that includes both debilitating hip osteoarthritis and low back pain. Abnormal spinal sagittal alignment and difficulty in maintaining proper balance, as well as a wobbling gait, may be caused by severe osteoarthritis of the hip joint. Epidural injections are used to determine a primary pain generator in this condition. 

Spondylolisthesis and nerve root irritation^{13, 30-33} - Degenerative lumbar spondylolisthesis is the displacement of a vertebra in the lower part of the spine; one lumbar vertebra slips forward on another with an intact neural arch and begins to press on nerves. The most common cause, in adults, is degenerative disease; although, it may also result from bone diseases and fractures. Degenerative spondylolisthesis is not always symptomatic. Epidural injections may be used to determine a previously undocumented nerve root irritation because of spondylolisthesis.

Lumbar spinal stenosis with radiculitis^13,34,35: Spinal stenosis is narrowing of either the spinal column or of the neural foramina where spinal nerves leave the spinal column, causing pressure on the spinal cord. The most common cause is degenerative changes in the lumbar spine. Neurogenic claudication is the most common symptom, with leg symptoms including the buttock, groin, and anterior thigh; however, symptoms may also radiate down along the posterior leg to the foot. In addition to pain, leg symptoms can include fatigue, heaviness, weakness, or paresthesia. Some individuals may also suffer from accompanying back pain. Symptoms are worse when standing or walking and are relieved by sitting. Lumbar spinal stenosis is often a disabling condition, and it is the most common reason for lumbar spinal surgery in adults over 65 years. The most common levels of stenosis are L3 through L5, but it may occur at multilevel in some individuals. Radiculitis is the inflammation of a spinal nerve root that causes pain to radiate along the nerve paths. Epidural injections help to ascertain the level of the pain generator in this condition.

Lumbar herniated disc^36,37,38,39: Epidural steroid injections have been proven to be effective at .reducing symptoms of lumbar herniated discs. Observation and epidural steroid injection are effective nonsurgical treatments for this condition. 

Postoperative epidural fibrosis^40,41,42: Epidural fibrosis is a common cause of failed back surgery syndrome. With the removal of a disc, the mechanical reason for pain may be removed, but an inflammatory condition may continue after the surgery and may cause pain. Epidural corticosteroids, with their anti-inflammatory properties, are used to treat postoperative fibrosis and may be used along with oral Gabapentin to reduce pain.

Failed back surgery syndrome (FBSS)^21,43: Failed back surgery syndrome is characterized by persistent or recurring low back pain, with or without sciatica, following lumbar surgery. The most common cause of FBSS is epidural fibrosis triggered by a surgical procedure such as discectomy. The inflammation resulting from the surgical procedure may start the process of fibrosis and cause pain. Epidural steroid injections are administered to reduce pain.

References

1. Manchikanti L, Knezevic NN, Navani A, et al. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. Jan 2021;24(S1):S27-s208. 
2. Summers J. International Spine Intervention Society Recommendations for treatment of Cervical and Lumbar Spine Pain. 2013.
3. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013;16(2 Suppl):S49-283. 
4. Kreiner DS, Hwang S, Easa J, et al. Clinical guidelines for diagnosis and treatment of lumbar disc herniation with radiculopathy. North American Spine Society (NASS). Updated 2012. Accessed January 19,  2022.   https://chiro.org/LINKS/GUIDELINES/Clinical_Guideline_for_the_Diagnosis_and_Treatment_of_Lumbar_Disc_Herniation_with_Radiculopathy.pdf
5. Akuthota V, Bogduk N, Easa JE, et al. Lumbar Transforaminal Epidural Steroid Injections: Review and Recommendation Statement. North American Spine Society (NASS). Updated January 2013. Accessed January 19, 2022. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/LTFESIReviewRecStatement.pdf
6. Daniell JR, Osti OL. Failed Back Surgery Syndrome: A Review Article. Asian Spine J. Apr 2018;12(2):372-379. doi:10.4184/asj.2018.12.2.372
7. Orhurhu VJ, Chu R, J G. Failed Back Surgery Syndrome. StatPearls Publishing. May 22, 2023. Updated May 8, 2022. Accessed March 30, 2023. https://www.ncbi.nlm.nih.gov/books/NBK539777/
8. Singh JR, Cardozo E, Christolias GC. The Clinical Efficacy for Two-Level Transforaminal Epidural Steroid Injections. Pm r. Apr 2017;9(4):377-382. doi:10.1016/j.pmrj.2016.08.030
9. Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Apr 4 2017;166(7):514-530. doi:10.7326/m16-2367
10. Authority WSHC. Health Technology Reviews - Spinal Injections. Washington State Health Care Authority. Accessed May, 2023. https://www.hca.wa.gov/about-hca/programs-and-initiatives/health-technology-assessment/spinal-injections
11. Authority WSHC. Health Technology Assessment Spinal Injections. Washington State Health Care Authority. May 25, 2023. Updated May 20, 2016. Accessed May 25, 2023. https://www.hca.wa.gov/assets/program/spinal_injections-rr_final_findings_decision_060216.pdf
12. Authority WHC. About the Health Care Authority (HCA). Washington Health Care Authority. May, 2023. Accessed May, 2023. https://www.hca.wa.gov/about-hca
13. Hassan KZ, Sherman AL. Epidural Steroids. StatPearls Publishing Copyright © 2022, StatPearls Publishing LLC. Updated January 2, 2022. Accessed April 13, 2022. https://www.ncbi.nlm.nih.gov/books/NBK537320/
14. Knezevic NN, Paredes S, Cantillo S, Hamid A, Candido KD. Parasagittal Approach of Epidural Steroid Injection as a Treatment for Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Front Pain Res (Lausanne). 2021;2:676730. doi:10.3389/fpain.2021.676730
15. Manchikanti L, Knezevic E, Knezevic NN, et al. Epidural Injections for Lumbar Radiculopathy or Sciatica: A Comparative Systematic Review and Meta-Analysis of Cochrane Review. Pain Physician. Aug 2021;24(5):E539-e554. 
16. North American Spine Society (NASS). Five things physicians and patients should question: Don’t perform elective spinal injections without imaging guidance, unless contraindicated. ABIM. Updated 2021. Accessed April 21, 2022. https://www.choosingwisely.org/clinician-lists/north-american-spine-society-elective-spinal-injections-without-imaging-guidance/
17. Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of low back pain. North American Spine Society(NASS). Updated 2020. Accessed April 13, 2022. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf
18. Manchikanti L, Knezevic E, Knezevic NN, et al. A Comparative Systematic Review and Meta-Analysis of 3 Routes of Administration of Epidural Injections in Lumbar Disc Herniation. Pain Physician. Sep 2021;24(6):425-440. 
19. Yang C, Kim NE, Beak JS, Tae NY, Eom BH, Kim BG. Acute cervical myelopathy with quadriparesis after cervical transforaminal epidural steroid injection: A case report. Medicine (Baltimore). Dec 2019;98(50):e18299. doi:10.1097/md.0000000000018299
20. Zhang X, Shi H, Zhou J, et al. The effectiveness of ultrasound-guided cervical transforaminal epidural steroid injections in cervical radiculopathy: a prospective pilot study. J Pain Res. 2019;12:171-177. doi:10.2147/jpr.S181915
21. Celenlioglu AE, Sencan S, Bilim S, Sancar M, Gunduz OH. Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post Lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Trial. Pain Physician. Mar 2022;25(2):161-169. 
22. Hashemi M, Dadkhah P, Taheri M, Ghasemi M. Effects of Caudal Epidural Dexmedetomidine on Pain, Erythrocyte Sedimentation Rate and Quality of Life in Patients with Failed Back Surgery Syndrome; A Randomized Clinical Trial. Bull Emerg Trauma. Jul 2019;7(3):245-250. doi:10.29252/beat-070306
23. Chang MC, Lee DG. Clinical effectiveness of caudal epidural pulsed radiofrequency stimulation in managing refractory chronic leg pain in patients with postlumbar surgery syndrome. J Back Musculoskelet Rehabil. 2020;33(3):523-528. doi:10.3233/bmr-170981
24. American College of Radiology. ACR Appropriateness Criteria® Low Back Pain. American College of Radiology (ACR). Updated 2021. Accessed November 10, 2021. https://acsearch.acr.org/docs/69483/Narrative/
25. Sculco AD, Paup DC, Fernhall B, Sculco MJ. Effects of aerobic exercise on low back pain patients in treatment. Spine J. Mar-Apr 2001;1(2):95-101. doi:10.1016/s1529-9430(01)00026-2
26. Durmus D, Unal M, Kuru O. How effective is a modified exercise program on its own or with back school in chronic low back pain? A randomized-controlled clinical trial. J Back Musculoskelet Rehabil. 2014;27(4):553-61. doi:10.3233/bmr-140481
27. Miyagi M, Fukushima K, Inoue G, et al. Hip-spine syndrome: cross-sectional-study of spinal alignment in patients with coxalgia. Hip Int. Jan 2019;29(1):21-. doi:10.1177/1120700018803236
28. Devin CJ, McCullough KA, Morris BJ, Yates AJ, Kang JD. Hip-spine syndrome. J Am Acad Orthop Surg. Jul 2012;20(7):434-42. doi:10.5435/jaaos-20-07-434
29. Younus A, Kelly A. Hip spine syndrome – A case series and literature review. Interdisciplinary Neurosurgery. 2021/03/01/2021;23:100960. doi:https://doi.org/10.1016/j.inat.2020.100960
30. Sindhi V, Lim CG, Khan A, Pino C, Cohen SP. Dural puncture during lumbar epidural access in the setting of degenerative spondylolisthesis: case series and risk mitigation strategies. Reg Anesth Pain Med. Nov 2021;46(11):992-996. doi:10.1136/rapm-2021-102963
31. Reitman CA, Cho CH, Bono CM, et al. Management of degenerative spondylolisthesis: development of appropriate use criteria. Spine J. Aug 2021;21(8):1256-1267. doi:10.1016/j.spinee.2021.03.005
32. Gerling MC, Bortz C, Pierce KE, Lurie JD, Zhao W, Passias PG. Epidural Steroid Injections for Management of Degenerative Spondylolisthesis: Little Effect on Clinical Outcomes in Operatively and Nonoperatively Treated Patients. J Bone Joint Surg Am. Aug 5 2020;102(15):1297-1304. doi:10.2106/jbjs.19.00596
33. Demir-Deviren S, Ozcan-Eksi EE, Sencan S, Cil H, Berven S. Comprehensive non-surgical treatment decreased the need for spine surgery in patients with spondylolisthesis: Three-year results. J Back Musculoskelet Rehabil. 2019;32(5):701-706. doi:10.3233/bmr-181185
34. Manchikanti L, Knezevic NN, Boswell MV, Kaye AD, Hirsch JA. Epidural Injections for Lumbar Radiculopathy and Spinal Stenosis: A Comparative Systematic Review and Meta-Analysis. Pain Physician. Mar 2016;19(3):E365-410. 
35. Wu L, Cruz R. Lumbar Spinal Stenosis. StatPearls Publishing LLC. Updated August 25, 2021. Accessed April 14, 2022. https://pubmed.ncbi.nlm.nih.gov/30285388/
36. Bhatia A, Flamer D, Shah PS, Cohen SP. Transforaminal Epidural Steroid Injections for Treating Lumbosacral Radicular Pain from Herniated Intervertebral Discs: A Systematic Review and Meta-Analysis. Anesth Analg. Mar 2016;122(3):857-870. doi:10.1213/ane.0000000000001155
37. Lee JH, Kim DH, Kim DH, et al. Comparison of Clinical Efficacy of Epidural Injection With or Without Steroid in Lumbosacral Disc Herniation: A Systematic Review and Meta-analysis. Pain Physician. Sep 2018;21(5):449-468. 
38. Lee JH, Shin KH, Park SJ, et al. Comparison of Clinical Efficacy Between Transforaminal and Interlaminar Epidural Injections in Lumbosacral Disc Herniation: A Systematic Review and Meta-Analysis. Pain Physician. Sep 2018;21(5):433-448. 
39. Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up. Pain Physician. Jul-Aug 2012;15(4):273-86. 
40. Masopust V, Häckel M, Netuka D, Bradác O, Rokyta R, Vrabec M. Postoperative epidural fibrosis. Clin J Pain. Sep 2009;25(7):600-6. doi:10.1097/AJP.0b013e3181a5b665
41. Häckel M, Masopust V, Bojar M, Ghaly Y, Horínek D. The epidural steroids in the prevention of epidural fibrosis: MRI and clinical findings. Neuro Endocrinol Lett. Mar 2009;30(1):51-5. 
42. Braverman DL, Slipman CW, Lenrow DA. Using gabapentin to treat failed back surgery syndrome caused by epidural fibrosis: A report of 2 cases. Arch Phys Med Rehabil. May 2001;82(5):691-3. doi:10.1053/apmr.2001.21867
43. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. Nov-Dec 2010;13(6):509-21. 

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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