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JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO ACTION: ☐ New Policy ☒ Revising Policy Number: CMS18.05 ☐ Superseding Policy Number ☐ Archiving Policy Number ☐ Retiring Policy Number Policy Number CMS18.05 Page 1 of 9 Effective Date: 03/06/2015 Review Dates: 03/06/15, 03/04/16 Johns Hopkins HealthCare (JHHC) provides a full spectrum of health care products and services for Employer Health Programs, Priority Partners, and US Family Health Plan. Each line of business possesses its own unique contract and guidelines which, for benefit and payment purposes, should be consulted to know what benefits are available for reimbursement. Specific contract benefits, guidelines or policies supersede the information outlined in this policy. POLICY: For US Family Health Plan see TRICARE Policy Manual 6010.57-M, February 1, 2008, Nervous System: Chapter 4, Section 20.1. This policy will focus on the following procedures for the treatment of back pain: Facet blocks Radiofrequency Ablation Percutaneous Vertebroplasty Percutaneous Kyphoplasty Percutaneous Sacroplasty I. Facet Blocks [back to top] A. When benefits are provided under the member’s contract, JHHC considers facet blocks medically necessary for the diagnosis of facet pain in persons with moderate to severe chronic* back or neck pain lasting more than 3 consecutive months when ALL of the following criteria are met: 1. Low back (lumbar/sacral), neck (cervical), or sacroiliac pain, suggestive of facet joint origin as evidenced by absence of nerve root compression as documented in the medical record on history, physical and radiographic evaluations; AND 2. Pain has failed to respond to three months of conservative management which may consist of therapies such as physical therapy, manipulation, nonsteroidal antiinflammatory medications, acetaminophen, or a home exercise program. 3. A maximum of 1 set of diagnostic facet joint injections per spinal region (cervical or lumbar/sacral) per side are considered medically necessary as a diagnostic test of facetogenic back pain and a prognostic test for radiofrequency ablation therapy. 4. Up to 3 facet joint injections (intra-articular or medial branch blocks) per sitting constitute a “set” of facet joint injections. 5. If 50% pain reduction is documented with the first set of injections using the visual analog scale (See Appendix Figure 1) before and after the procedure, injections may be repeated once to confirm the diagnosis of facetogenic back pain at least one week JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS18.05 Page 2 of 9 (ideally two weeks) after the first block. Once a structure is proven to be negative as a pain generator, no repeat injections should be directed at that structure unless there is a new clinical presentation with symptoms, signs, and diagnostic studies of known reliability and validity which implicate that structure. 7. Fluoroscopic and CT guidance are included in the procedure consistent with CPT Coding rules and may not be billed separately with or without a modifier 59. Unless specific benefits apply, facet joint injections (intra-articular and medial branch blocks) are considered investigational as a therapeutic intervention (non-diagnostic) for back and neck pain and for all other indications as the effectiveness of this modality, other than as a diagnostic tool, has not been established. 6. B. II. Radiofrequency Ablation (RFA): [back to top] For the purpose of this policy, discussion of RFA refers to techniques that address pain attributed to facet or sacroiliac joints or radicular pain without a definitive cause. A. When benefits are provided under the member’s contract, JHHC considers radiofrequency ablation medically necessary for patients who meet ALL of the following criteria: 1. Pain is categorized as refractory† or severe*; AND 2. Low back (lumbar/sacral) or neck (cervical) pain is suggestive of facet joint origin as evidenced by absence of nerve root compression as documented in the medical record on history, physical and radiographic evaluations; AND 3. Pain has failed to respond, as documented in the medical record, to three months of conservative management which may consist of therapies such as nonsteroidal antiinflammatory medications, acetaminophen, manipulation, physical therapy, or a home exercise program. 4. No prior spinal fusion surgery in the area being treated; AND 5. Pain is not radicular, (arising in the back and radiating into the limbs); AND 6. A diagnostic, temporary block with local anesthetic of the facet nerve (medial branch block) or injection under fluoroscopic guidance into the facet joint has resulted in at least a 50% reduction in pain. 7. Pain management and pain measurement must be documented using a Pain Intensity Instrument such as the NIH Warren Grant Magnuson Clinical Center Scale, (Figure 1). B. Only 1 treatment procedure per level per side is medically necessary and covered in a 6month period, per American Society of Interventional Pain Physicians (ASIPP). Therapeutic frequency for medial branch neurotomy should remain at intervals of at least 6 months or longer per each region (maximum of 2 times per year) between each procedure, provided that 50% or greater relief is obtained for 10 to 12 weeks. It is further suggested that all regions be treated at the same time, provided all procedures are performed safely. (Manchikanti et al. 2009). C. Unless specific benefits apply, JHHC considers Radiofrequency denervation investigational for the treatment of chronic spinal/back pain without definitive cause, as it does not meet TEC criteria #2-5. D. Unless specific benefits apply, JHHC considers Radiofrequency denervation investigational for the treatment of headaches, as it does not meet TEC criteria #2-5. JOHNS HOPKINS HEALTHCARE Policy Number CMS18.05 Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Page 3 of 9 E. Unless specific benefits apply, JHHC considers pulsed radiofrequency investigational, as it does not meet TEC criteria #2-5. F. Unless specific benefits apply, JHHC considers thoracic RFA investigational, as it does not meet TEC criteria #2-5. III. Percutaneous Vertebroplasty [back to top] A. When benefits are provided under the member’s contract, JHHC considers percutaneous vertebroplasty medically necessary for the management of patients with osteolytic metastatic cancer or advanced osteoporosis. B. Unless specific benefits are provided, JHHC considers percutaneous vertebroplasty investigational for all other indications, as it does not meet TEC criteria #2-5. IV. Percutaneous Kyphoplasty [back to top] A. When benefits are provided under the member’s contract, JHHC considers percutaneous kyphoplasty medically necessary for the management of patients with osteolytic metastatic cancer or advanced osteoporosis. B. Unless specific benefits are provided, JHHC considers percutaneous kyphoplasty investigational for all other indications, as it does not meet TEC criteria #2-5. V. Percutaneous Sacroplasty [back to top] A. Unless specific benefits are provided, JHHC considers percutaneous sacroplasty investigational for all indications, as it does not meet TEC criteria #2-5. Consistent with the Statement on Anesthetic Care during Interventional Pain Procedures for Adults (2010) from the Anesthesia Society of America, general anesthesia and monitored anesthesia for the majority of minor pain procedures should not be used and are not considered medically necessary in the absence of medical documentation of unusual medical circumstances. APPENDIX I. Visual Analog Scale for Pain (Figure1): NIH Warren Grant Magnuson Clinical Center scale Indications: Adults and children (>9 years old) in all patient care settings who are able to use numbers to rate the intensity of their pain. (Figure and pain categories from National Institutes of Health Warren Grant Magnuson Clinical Center) JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS18.05 Page 4 of 9 II. Definitions *Moderate to severe pain is defined by consistent documentation using a Pain Intensity Instrument such as the NIH Warren Grant Magnuson Clinical Center scale, (Figure 1). *Chronic or persistent pain is defined as pain which lasts beyond the ordinary duration of time that an insult or injury to the body needs to heal. †Refractory pain is defined as pain that has failed to respond to three (3) months of conservative medical management as documented in the medical record including, BOTH: Therapeutic doses of pain medications including non-steroidal anti-inflammatory medications, acetaminophen, and/or opiates; AND Physical therapy as part of a comprehensive back program. III. Documentation 1. 2. 3. 4. 5. 6. Comprehensive Pain Evaluation (includes H&P and documents that other medical causes of chronic back pain have been identified and adequately treated) Imaging (report of MRI done within one year) Physical Therapy within 24 months documenting patient was compliant with at least 3 months of program for treating back pain; OR documentation of chiropractic intervention For RFA, documentation that patient has found pain relief after facet blocks Pain log or diary kept by patient using a communication tool such as The American Chronic Pain Association Pain Log at a frequency commensurate with the treatment offered. If diagnostic by use of short acting agents such as lidocaine, pain will be documented on an hourly basis for the first twenty-four hours after injection. For longer acting treatments, pain will be documented on an ongoing daily basis to determine treatment efficacy. Documentation is to follow standards outlined in the JHHC Medical Record Documentation Standards Policy, COR.026. http://www.hopkinsmedicine.org/johns_hopkins_healthcare/downloads/cor_026_medical_re cord_documentation_standards_2014.pdf BACKGROUND: Facet joint injections (intra-articular and medial branch blocks) are percutaneous procedures in which sensory afferent nerve fibers are blocked by short-acting local anesthetics or steroids in order to reduce pain. This procedure can be used to diagnose facet joint syndrome as the cause of chronic back pain when there is temporary or prolonged abolition of back pain following facet joint injection. Facet injections have been accepted as a diagnostic modality for patients with a variety of chronic spinal pain syndromes. Facet joint injections must be performed under imaging guidance to assure accurate placement of the needle in the facet joint or on the medial nerve branch of the facet joint. After a satisfactory block has been obtained, the patient is asked to indulge in activities that usually aggravated his/her pain and to record his/her impressions of the effect of the procedure 4-8 hours after the injection.2 Radiofrequency Ablation (RFA) is a percutaneous procedure in which an electrical current is used to heat up an area of nerve tissue, thereby decreasing pain from that specific area. RFA has been investigated and JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS18.05 Page 5 of 9 proven to be safe and effective as a treatment modality for patients with a variety of chronic spinal/back/neck pain syndromes resulting from arthritis and joint degeneration.1 Treatment objectives are to eliminate pain, reduce the likelihood of recurrence, and prolong the time to recurrence by selectively destroying pain fibers without inducing excessive sensory loss, motor dysfunction, or other complications.3 Percutaneous vertebroplasty (VP) is a therapeutic, interventional radiologic procedure for patients with painful vertebral compression fractures (VCFs) due to primary or secondary osteoporosis. It involves injection of bone cement into an osteolytic or osteoporotic fracture and is intended to relieve pain, improve mobility, and prevent further collapse of the bone.5,1 Percutaneous kyphoplasty (KP) is a therapeutic, interventional radiological procedure for patients with painful vertebral compression fractures (VCFs) due to primary or secondary osteoporosis or myeloma. It involves expansion of the partially collapsed vertebral body with an inflatable bone tamp, followed by injection of an acrylic polymer, which then hardens to maintain reduction of the fracture. Kyphoplasty is intended to relieve pain, restore vertebral body height, and provide stability.13 Percutaneous sacroplasty is a variation of the vertebroplasty technique for treating sacral insufficiency fracture (SIF) to restore the mechanical integrity and stability of the sacrum and, thereby, relieve pain and restore mobility. Percutaneous sacroplasty, including sacral kyphoplasty, involves the injection of acrylic (polymethylmethacrylate [PMMA]) or bioceramic bone cement into the SIF under the guidance of computed tomography (CT).14 CODING INFORMATION: CPT Copyright 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Note: The following CPT/HCPCS codes are included below for informational purposes. Inclusion or exclusion of a CPT/HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. The member's specific benefit plan determines coverage and referral requirements. All inpatient admissions require pre-authorization. PRE-AUTHORIZATION REQUIRED Compliance with the provision in this policy may be monitored and addressed through post-payment data analysis and/or medical review audits Employer Health Programs (EHP) **See Specific Summary Plan Description (SPD) CPT ® CODES 22510 Priority Partners (PPMCO) refer to COMAR guidelines and PPMCO SPD then apply policy criteria US Family Health Plan (USFHP), TRICARE Medical Policy supersedes JHHC Medical Policy. If there is no Policy in TRICARE, apply the Medical Policy Criteria DESCRIPTION Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO Policy Number CMS18.05 Page 6 of 9 unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic 22511 22512 22513 22514 22515 64490 64491 64492 64493 64494 64495 64633 64634 Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure) Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body (List separately in addition to code for primary procedure) Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; single level Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; second level (List separately in addition to code for primary procedure) Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; third and any additional level(s) (List separately in addition to code for primary procedure) Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; single level Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; second level (List separately in addition to code for primary procedure) Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third and any additional level(s) (List separately in addition to code for primary procedure) Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional facet joint (List separately in addition to code for primary procedure) JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO 64635 64636 Policy Number CMS18.05 Page 7 of 9 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, single facet joint Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional facet joint (List separately in addition to code for primary procedure) REVENUE DESCRIPTION CODES Operating Room Services-General-Hospital; outpatient 0360 Ambulatory Surgical Care-General-Hospital; outpatient 0490 NOT COVERED CPT ® CODES 0200T 0201T DESCRIPTION Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles, includes imaging guidance and bone biopsy, when performed Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles, includes imaging guidance and bone biopsy, when performed ICD10 CODES ARE FOR INFORMATIONAL PURPOSES ONLY Employer Health Programs (EHP) **See Specific Summary Plan Description (SPD) ICD10 CODES C41.2 C41.4 C79.51C79.52 M50.2M50.93 M51.0M51.37 M53.81M53.83 M54.2 M54.3 Priority Partners (PPMCO) refer to COMAR guidelines and PPMCO SPD then apply policy criteria US Family Health Plan (USFHP), TRICARE Medical Policy supersedes JHHC Medical Policy. If there is no Policy in TRICARE, apply the Medical Policy Criteria DESCRIPTION Malignant neoplasm of vertebral column Malignant neoplasm of pelvic bones, sacrum and coccyx Secondary malignant neoplasm of bone and bone marrow Cervical disc disorder Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders Other specified dorsopathies [cervical region] [covered for the diagnosis of facet pain with chronic back or neck pain lasting more than 3 consecutive months] Cervicalgia [covered for the diagnosis of facet pain with chronic back or neck pain lasting more than 3 consecutive months] Sciatica JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO M54.5 M54.6 M54.9 M81.0M81.8 Policy Number CMS18.05 Page 8 of 9 Low back pain [lumbago] Pain in thoracic spine [covered for the diagnosis of facet pain with chronic back or neck pain lasting more than 3 consecutive months] Dorsalgia, unspecified Osteoporosis REFERENCES STATEMENT: Analyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCare Medical Policy Team during the development and implementation of this medical policy. Per NCQA standards, the Medical Policy Team will continue to monitor and review any newly published clinical evidence and adjust the references below accordingly if deemed necessary. CLINICAL 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Derrer D. (2013, October 1). Radiofrequency Ablation for Chronic Pain. Reviewed January 2, 2015. Retrieved from: http://www.webmd.com/pain-management/radiofrequencyablation?page=3 Schutz U, Cakir B, et al. (2011) Diagnostic Value of Lumbar Facet Joint Injection: A Prospective Triple Cross-Over Study. PLoS ONE 6(11): e27991. Bicket M, Horowitz J, et al. Epidural Injections in Prevention of Surgery for Spinal Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials. The Spine Journal (2014); pii:S1529-9430(14)-1569-1. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: A Review of the Evidence for an American Pain Society Clinical Practice Guideline. Spine. 2009;34(10):1078-1093. Yang SC, Chen HS, et al. Clinical Evaluation of Percutaneous Vertebroplasty for Symptomatic Adjacent Vertebral Compression Fracture. Journal of Spinal Disorder and Technology. 2013; 24(4); p. 130-136. Niemisto L., Kalso E., Malmivaara A., et al. Radiofrequency Denervation for Neck and Back Pain: A Systematic Review within the Framework. Cochrane Collaboration Back Review Group. Reviewed: January 2, 2015. Retrieved from: http://www.bestbets.org/bets/bet.php?id=992 Cohen SP, Strassels SA, et al. Outcome Predictors for Sacroiliac Joint (lateral branch) Radiofrequency Denervation. Reg. Anesthesia and Pain Medicine (2009): Retrieved from: http://www.ncbi.nlm.nih.gov/pubmed/19587617 Cohen SP, Huang JHY, Brummett C. Facet joint pain—advances in patient selection and treatment. Nature Reviews (2013); 9:101-116. Cohen SP, Raja SN. Pathogenesis, Diagnosis, and Treatment of Lumbar Zygapophysial Joint Pain. Anesthesiology (2007); 106(3):591-614. American Chronic Pain Association. Communication Tools. http://www.theacpa.org/Communication-Tools Molina HealthCare. Radiofrequency Ablation for Chronic Low Back Pain. Reviewed January 2, JOHNS HOPKINS HEALTHCARE Medical Policy: Back Pain – Invasive Procedures Department: Medical Management Lines of Business: EHP, USFHP, PPMCO 12. 13. 14. 15. 16. 17. 18. 19. Policy Number CMS18.05 Page 9 of 9 2015. Retrieved from: http://www.molinahealthcare.com/providers/sc/medicaid/PDF/Radiofrequency-Ablation-forchronic-back-pain-MCG-085.pdf Hayes. Epidural Steroid Injections for Low Back Pain and Sciatica. https://www.hayesinc.com/subscribers/subscriberHome.do Hayes. Percutaneous Vertebroplasty. https://www.hayesinc.com/subscribers/subscriberHome.do Hayes. Percutaneous Kyphoplasty: https://www.hayesinc.com/subscribers/subscriberHome.do Hayes. Percutaneous Sacroplasty. https://www.hayesinc.com/subscribers/subscriberHome.do Aetna Clinical Policy Bulletin. Clinical Policy Bulletin No. 0735. Pulsed Radiofrequency. Reviewed on January 2, 2015. Retrieved from: http://www.aetna.com/cpb/medical/data/700_799/0735.html Aetna Clinical Policy Bulletin. Clinical Policy Bulletin No. 0016. Back Pain – Invasive Procedures. Last Review January 2, 2015. Retrieved from: http://www.aetna.com/cpb/medical/data/1_99/0016.html United HealthCare Policy. Radiofrequency Ablation for Orthopedic Pain. Retrieved from: https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/enUS/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20 and%20Protocols/Medical%20Policies/Medical%20Policies/Ablative_Treatment_for_Spinal_Pa in.pdf United HealthCare Policy. Epidural Steroid and Facet Injections for Spinal Pain. Retrieved from: https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/enUS/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20 and%20Protocols/Medical%20Policies/Medical%20Policies/Epidural_Steroid_and_Facet_Inject ions_for_Spinal_Pain.pdf REGULATORY 20. 21. 22. 23. TRICARE Policy Manual 6010.57-M, February 1, 2008, Surgery: Chapter 4, Section 20.1, Nervous System. Retrieved from: http://manuals.tricare.osd.mil TRICARE Policy Manual 6010.57-M, February 1, 2008, Surgery: Chapter 4, Section 6.1, Musculoskeletal System. Retrieved from: http://manuals.tricare.osd.mil TRICARE Policy Manual 6010.57-M, February 1, 2008, Radiology: Chapter 5, Section 1.1, Diagnostic Radiology (Diagnostic Imaging). Retrieved from: http://manuals.tricare.osd.mil TRICARE Policy Manual 6010.57-M, February 1, 2008, Radiology: Chapter 5, Section 2.1, Diagnostic Radiology (Diagnostic Ultrasound). Retrieved from: http://manuals.tricare.osd.mil