Clinical Policy Title: Radiofrequency ablation treatment for spine pain Clinical Policy Number: 03.02.02 Effective Date: June 1, 2013 Initial Review Date: March 21, 2013 Most Recent Review Date: March 18, 2015 Next Review Date: March 2016 Policy contains: Non-pulsed radiofrequency ablation (NRFA). Related Policies: 03.03.01 Spinal Cord Stimulators 03.03.03 Spinal surgeries 03.03.04 Spine Pain--Epidural Pain 03.03.05 IV Lidocaine Infusion for Neuropathic Pain 03.03.06 Biofeedback 03.03.07 Spine Pain--Facet Joint Injection 03.03.08 Spine Pain--Trigger Point Injection Pending Radiofrequency ablation uterine fibroids ABOUT THIS POLICY: Keystone VIP Choice has developed clinical policies to assist with making coverage determinations. Keystone VIP Choice 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 Keystone VIP Choice 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. Keystone VIP Choice 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. Keystone VIP Choice clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone VIP Choice will update its clinical policies as necessary. Keystone VIP Choice clinical policies are not guarantees of payment. Coverage policy Keystone VIP Choice considers the use of non-pulsed radiofrequency ablation (NRFA) for cervical and lumbar facet joints to be clinically proven and, therefore, medically necessary when the following criteria are met: A lumbar facet joint origin of pain is suspected and medial branch block/injection of facet joint with local anesthetic results in the marked decrease in intensity or elimination of pain. The spinal pain is exacerbated by extension and rotation or associated with lumber rigidity. 1
The individual continues to have pain unresponsive to conservative medical management with conventional therapies which limits activities of daily living for at least a continuous three-month period. The individual does not have a history of spinal fusion surgery in the specific vertebral areas where the NRFA treatment will be applied. Other clinical findings and imaging studies are not indicative of other causes of spine pain, including, but not limited to, disc degeneration or herniation, infection, fracture or malignancy. Limitations: As pain relief from denervation may not be permanent, repeat NRFA to the same levels of the spine may be considered medically necessary as follows: When prior treatment has been successful, as evidenced in the achievement of a 50 percent or more reduction in pain for 10 to 12 weeks and concurrent functional improvement. When more than six months have elapsed since the last treatment per level, per side. NRFA for the spine is considered unproven and not medically necessary for certain indications. This list of indications includes, but is not limited to, the following: The pain is of cervical or thoracic origin. Instances of no improvement in pain after a medical branch block injection. Less than a six-month interval between treatments at the same anatomical site. More than two treatments at the same anatomical site within a twelve-month period. Additionally, NRFA is not to be used in the presence of the following: Any neurological deficits. Diabetic neuropathies. Regional pain disorders and syndromes in the absence of spinal pain. Clinically diagnosed causes of spinal pain that require other specific treatment, including but not limited to disc herniation, infection, malignancy and trauma. NRFA for the thoracic spine and sacroiliac (SI) joint is considered unproven and not medically necessary, as no evidence for its use has been established in peer-reviewed professional literature. Long term, maintenance denervation by NRFA is considered unproven and not medically necessary for any indication, as its use has not been established in peer-reviewed professional literature. Pulsed radiofrequency ablation (PRFA) for all indications is not considered to be evidence-based, as its use is unsupported in peer-reviewed professional literature, and is not a covered service. All other uses of NRFA therapies are not medically necessary. Alternative covered services: Pharmaceutical therapy, e.g., analgesics. Physical and occupational therapy. Background Chronic pain affects the health of a large segment of the population. Demographic data shows a greater incidence and severity of spine pain in populations with less education. Although most cases of back pain are resolved with conservative treatment such as rest and physical therapy, in certain instances back pain 2
may become a chronic condition. Primary areas of chronic pain may be located in the upper and lower spine. Effective treatment may be difficult without a clear cause of the pain. Nerve block studies may be used for chronic neck and back pain, with findings pointing to a disorder of the facet joint. Individuals with a confirmed ability for pain relief following a nerve block study may be considered for NRFA treatment. There are two types of radiofrequency ablation (RFA): non-pulsed and pulsed. Typically, NRFA systems are made of three components: a generator, needle electrodes and grounding pads. NRFA uses the placement of an electrode and an undisrupted high-voltage, high-frequency electrical current for a predetermined amount of time to disrupt pain signals sent to the brain from a specific body area. The current produces heat and coagulation, causing denervation in the targeted tissue sites. Denervation is thought to be achieved by selectively destroying sensory afferent pain fibers without causing untoward motor dysfunction, sensory loss or other complications. Treatment should be directed to at least two levels of a single joint for successful denervation. Destruction of nerve fibers may be temporary or permanent. In some cases the treated nerve repairs itself and becomes less irritable, resulting in continued pain abatement. In other cases where the pain returns, the procedure may be repeated. NRFA has been studied as a treatment modality for patients with a variety of chronic spinal pain syndromes, including SI pain, facet joint pain and discogenic pain not associated with disc herniation. NRFA may be used for pain reduction in individuals with upper and lower spine pain unresponsive to conservative therapies when there is no definitive indication for surgery. The other type of radiofrequency ablation is PRFA. It delivers short bursts of radiofrequency (RF) current, instead of the continuous flow of RF current produced by continuous RF generators. The interrupted, short bursts of high voltage electrical current allow the tissue to cool, resulting in lower maximum temperatures than NRFA, and do not cause tissue coagulation. PRFA has been introduced as a non-ablative alternative to NRFA; however, it has not been studied in large prospective clinical trials, and there is a paucity of peerreviewed professional literature addressing its therapeutic effectiveness. Guidelines from medical professional societies and studies from peer-reviewed professional literature indicate that non-pulsed radiofrequency ablation (NRFA) therapy does provide evidence of effectiveness when applied to specific areas of the spine. Professional literature suggests NRFA to a facet joint of the cervical and lumbar regions provides pain relief by interruption or denervation, and the success rate is dependent on the careful selection of individuals to receive the treatment. The 2010 American Society of Anesthesiologists (ASA) practice guidelines support the use of conventional NRFA of the medial branch nerves to the facet joint for low back (medial branch) pain when previous diagnostic or therapeutic injections of the joint or medial branch nerve have provided temporary relief. Conventional NRFA may also be considered for neck pain. The American Society of Interventional Pain Physicians (ASIPP, 2009) practice guidelines state the suggested therapeutic frequency for treatment should remain at intervals of at least six months per each region (maximum of twice per year), provided that 50 percent 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). This policy reviews the effectiveness of radiofrequency ablation to regions of the spine. Methods: Searches: 3
Keystone VIP Choice searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidencebased practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on March 11, 2015, using the terms radiofrequency ablation and radiofrequency neurotomy. 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 Cervical: Professional literature investigating therapeutic interventions with the use of RFA for the management of chronic cervical neck pain is limited. Early studies assessed participants for when pain returned to 50 percent or more of pretreatment levels. An average return of pain after a three-month period was assessed by functional status. A current, systemic review of therapeutic interventions for cervical facet joint interventions (Falco et al., 2012) provides a final analysis of four randomized trials and six observational studies that indicate the evidence for cervical radiofrequency neurotomy is only fair, as is that of cervical medial branch blocks. There is inadequate evidence of significant impact of radiofrequency ablation for cervical disease. Thoracic: A systemic review to determine the clinical utility of therapeutic thoracic interventions for the management of chronic pain in the upper and mid spine area identified a total of four studies that met inclusion criteria for methodological quality assessment. The primary outcome measure was pain relief; the secondary outcome measures were improvement in functional and psychological status, reduction in analgesic intake, and return to work. The evidence was fair for therapeutic thoracic facet joint nerve blocks and limited for radiofrequency therapy. The review concluded that the evidence for the use of radiofrequency therapy for the thoracic spine was limited due to lack of peer-reviewed professional literature (Manchikanti et al., 2012). Lumbar: A randomized controlled study of NRFA was conducted in patients with chronic low back pain (20 active and 20 controls). Inclusion criteria were three separate positive diagnostic blocks, and subjects were examined before and after the treatment (sham or active). The active treatment group showed statistically significant improvement in back and leg pain and also back and hip movement. There was significant improvement in quality of life variables, global perception of improvement and generalized pain. The improvement noted in the active group was significantly greater than that of the placebo group. None of the study participants had complications other than transient post-procedure pain. The study concluded that radiofrequency facet denervation could be used in the treatment of carefully selected patients with chronic low back pain (Nath, 2008). Sacroiliac: The SI joint has been identified as a primary source of chronic low back pain. Studies provide limited evidence regarding the efficacy and safety of RFA for individuals with SI joint pain, and contain insufficient data to allow for definitive conclusions. Studies suggest that NRFA may provide three- to six- 4
month (short-term) pain relief. To date, there are no definitive patient selection criteria for the use of RFA for SI joint pain. Based on the available evidence, Hayes, Inc. assigns a level C rating for the use of NRFA for treatment of SI joint pain (Hayes, 2012). ASIPP 2010 practice guidelines for chronic spinal pain site that the use of radiofrequency of medial branches also state the evidence for NRFA and PRFA of the SI joint is limited. These guidelines also state the evidence for PRFA for SI pain is inconclusive (Boswell et al., 2007). Quality of evidence and additional research: According to Hayes, Inc., clinical studies for the use of RFA for chronic spinal pain have significant methodological limitations that may impact the interpretation of data. Few randomized controlled or comparative trials of RFA with adequate sample size and follow-up duration have been published; the majority of evidence is taken from small randomized controlled trials, prospective uncontrolled studies, case series and retrospective chart analyses. Uncertainties regarding several aspects of RFA for spinal pain necessitate additional research. Questions remain about the etiology of facet joint syndrome, the prognostic validity of diagnostic nerve blocks, standard outcome measures, the role of the placebo effect in treatment success and the radiofrequency denervation technique. The validation of radiofrequency for chronic spinal pain management relies upon the resolution of these technical issues as well as issues regarding patient selection and long-term efficacy (Hayes, 2012). As of the writing of this policy, the Centers for Medicare and Medicaid Services (CMS) has not developed a national coverage determination for RFA for chronic spine pain. Summary of clinical evidence: Citation Hooten (2005) Niemisto (2003) Content, Methods, Recommendations Key Point: Meta-analysis of the three RCTs and two systemic reviews. Significant methodological problems exist with patient selection and study design. As a result, the studies have an error in published impact of the effectiveness of RFA. Key Point: Limited evidence that radiofrequency denervation offers short-term relief for chronic neck pain of zygapophysial joint origin and for chronic cervicobrachial pain. Conflicting evidence for its effectiveness for lumbar zygapophysial joint pain. Limited evidence suggesting intradiscal radiofrequency may not be effective in relieving discogenic low back pain. Glossary Chronic back pain Back pain present for more than three months. Denervation The selective destruction of sensory pain fibers in a nerve. Facet joint The space between the articular processes (zygapophytes) of the spine bones. 5
Pulsed radiofrequency ablation (PRFA) PRFA delivers short, interrupted bursts of high voltage electrical current that does not cause tissue coagulation. Non-pulsed radiofrequency ablation (NPRA) Undisrupted, continuous high-voltage electrical current that does not cause tissue coagulation for a prescribed, predetermined amount of time. Radiofrequency ablation (RFA) A technique that uses high-frequency current to produce heat and tissue coagulation. RFA may be referenced by other terms, such as radiofrequency coagulation, radiofrequency denervation, radiofrequency lesioning, radiofrequency neuroablation, radiofrequency neurotomy, percutaneous radiofrequency neuroablation, articular rhizolysis or rhizotomy. Related policies Keystone VIP Choice Utilization Management program description. References Professional society guidelines/other: American Chronic Pain Association (ACPA). Office of Disease Prevention and Health Promotion. Web site. 2004. Available at: http://www.healthfinder.gov/orgs/hr2428.htm. Accessed March 29, 2014. American Society of Anesthesiologists (ASA). Practice Guidelines for Chronic Pain Management. An Updated Report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology 2010;112:810 33. http://www.asahq.org/. Accessed March 29, 2014. Manchikanti L, Boswell M, Singh V, et al.; American Society of Interventional Pain Physicians (ASIPP). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009;12:699 802. [ASIPP Web site]. Available at: http://www.painphysicianjournal.com/2009/july/2009;12;699-802.pdf. Accessed March 29, 2014. Chou R, Qaseem A, Snow V, et al. Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2 October 2007;147(7):478 491. Available at: http://annals.org/article.aspx?articleid=736814. Accessed March 29, 2014. Peer-reviewed references: Boswell MV, Shah RV, Everett CR, et al. Interventional techniques in the management of chronic spinal pain: evidence-based practice guidelines. National Guideline Clearinghouse. Pain Physician. 2007 Jan; 10(1):7 111. Agency for Healthcare Research and Quality (AHRQ). [AHRQ Website.] http://www.guideline.gov/content.aspx?id=45379. Accessed March 29, 2014. Boswell MV, Colson JD, Sehgal N, Dunbar EE, Epter R. A systematic review of therapeutic facet joint interventions in chronic spinal pain. Pain Physician. 2007 Jan;10(1):229 53. Cox RC, Fortin JD. The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. Pain Physician. 2014 Sep Oct;17(5):459 64. 6
Falco, F., Manchikanti, L., Datta, S., et al Systematic review of the therapeutic effectiveness of cervical facet joint interventions: an update. Pain Physician. 2012 Nov Dec; 15(6):E839 68. Falco FJ, Manchikanti L, Datta S, et al. An update of the effectiveness of therapeutic lumbar facet joint interventions. Pain Physician. 2012 Nov Dec; 15(6):E909 53. Hooten WM, Martin DP, Huntoon MA. Radiofrequency neurotomy for low back pain: evidence-based procedural guidelines. Pain Med. 2005 Mar Apr; 6(2):129 38 Manchikanti K, Atluri S, Singh V, et al. An update of evaluation of the therapeutic thoracic facet joint interventions. Pain Physician. 2012 Jul Aug;15(4):E463 81. Manchikanti L, Boswell M, Singh V, et al. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul Aug; 12(4):699 802. Agency for Healthcare Research and Quality (AHRQ). [AHRQ Website.] Available at: http://www.guideline.gov/content.aspx?id=15136&search=guidelines+for+chronic+spinal+pain. Accessed March 29, 2014. Nath S, Nath C, Pettersson K. Percutaneous lumber zygapophyseal (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain: a randomized double-blind trial. Spine. 2008 May 20;33(12);129107. Niemisto L, Kalso EA, Malmivaara A, Seitsalo S, Hurri H, Cochrane Collaboration, Back Review Group. Radiofrequency denervation for neck and back pain: a systematic review within the framework of the Cochrane collaboration back review group. Spine. 2003 Aug 15;28(16):1877 88. Patel N. Twelve-month follow-up of a randomized trial assessing cooled radiofrequency denervation as a treatment for sacroiliac region pain. Pain Pract. 2015 Jan 7. Hayes, Inc. Medical Technology Directory. Radiofrequency Ablation for Sacroiliac Joint Pain. Lansdale, PA: Hayer, Inc. August 21, 2012. Clinical trials: SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain, Relievant Medsystems Inc. NCT01446419 Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction NCT01104051 Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD): As of the writing of this policy, there are no NCDs for radiofrequency for the treatment of spinal pain. Local coverage determinations (LCDs): Wisconsin Physicians Service (WPS) Insurance Corporation (08101 - MAC - Part A). L30483. Paravertebral Facet Joint Block and Facet Joint Denervation. Original March 18, 2010. Revision effective October 1, 2013. Centers for Medicare (CMS) website. Available at: http://www.cms.gov/medicare-coveragedatabase/details/lcd-details.aspx?lcdid=30483&contrid=264. Accessed March 11, 2015. 7
Medicare, WPS, and LCD: L30483: The effects of denervation should last from six months to one year or longer. In some instances the effects may be permanent. Repeat denervation procedures at the same joint/nerve level will only be considered medically necessary when the patient has had significant improvement of pain after the initial facet joint nerve destruction that lasted an appropriate period of time (greater than or equal to six months). http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?lcdid=30483&contrid=266. Accessed March 11, 2015 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 accordingly. CPT Code Description Comment 64633 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint 64634 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) 64635 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) 64636 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) ICD-9 Code Description Comment 721.0 Cervical spondylosis with myelopathy 721.1 Cervical spondylosis without myelopathy 721.3 Lumbosacral spondylosis without myelopathy 721.42 Spondylosis with myelopathy 721.90 Spondylosis of unspecified site without myelopathy 723.1 Cervicalgia 723.9 Unspecified musculoskeletal disorders and symptoms referable to neck 724.2 Lumbago 724.9 Other specified back disorders ICD-10 Code Description Comment M25.50 Pain in unspecified Joint M43.00 Spondylolysis, site unspecified M43.02 Spondylolysis, cervical region M43.06 Spondylolysis, lumbar region 8
M43.10 Spondylolisthesis, site unspecified M43.12 Spondylolisthesis, cervical region M43.16 Spondylolisthesis, lumbar region M43.20 Fusion of spine, site unspecified M43.22 Fusion of spine, cervical region M43.26 Fusion of spine, lumbar region M43.8X9 Other specified deforming dorsopathies, site unspecified M46.00 Spinal enthesopathy, site unspecified M46.02 Spinal enthesopathy, cervical region M46.06 Spinal enthesopathy, lumbar region M47.012 Anterior spinal artery compression syndromes, cervical region M47.016 Anterior spinal artery compression syndromes, lumbar region M47.019 Anterior spinal artery compression syndromes, site unspecified M47.022 Vertebral artery compression syndromes, cervical region M47.029 Vertebral artery compression syndromes, site unspecified M47.10 Other spondylosis with myelopathy, site unspecified M47.12 Other spondylosis with myelopathy, cervical region M47.16 Other spondylosis with myelopathy, lumbar region M47.20 Other spondylosis with radiculopathy, site unspecified M47.22 Other spondylosis with radiculopathy, cervical region M47.26 Other spondylosis with radiculopathy, lumbar region Spondylosis without myelopathy or radiculopathy, occipitoatlanto-axial M47.811 region Spondylosis without myelopathy or radiculopathy, cervical M47.812 region Spondylosis without myelopathy or radiculopathy, lumbar M47.816 region Spondylosis without myelopathy or radiculopathy, site M47.819 unspecified M47.892 Other spondylosis, cervical region M47.896 Other spondylosis, lumbar region M47.899 Other spondylosis, site unspecified M47.9 Spondylosis, unspecified M53.80 Other specified dorsopathies, site unspecified M53.82 Other specified dorsopathies, cervical region M53.9 Dorsopathy, unspecified M54.2 Cervicalgia M54.5 Low back pain HCPCS Level II N/A Description Comment 9
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