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CGS Administrators, LLC 2 Vantage Way – Metro Center Nashville, TN 37228 May 19, 2020 Earl Berman, MD via Email: [email protected] Meredith Loveless, MD via Email: [email protected] Neil Sandler, MD via Email: [email protected] CGS Administrators, LLC 2 Vantage Way – Metro Center Nashville, TN 37228 Dear Drs. Berman, Loveless, and Sandler: The undersigned medical specialty societies, comprising physicians who utilize and/or perform interventional spine procedures to accurately diagnose and treat patients suffering from spine pathologies, would like to take this opportunity to express our strong support for coverage of facet joint and medial branch nerve procedures, and provide a detailed explanation of their importance to Medicare patients’ quality of life. Our societies have a strong record of working to eliminate fraudulent, unproven, and inappropriate procedures. At the same time, we are equally committed to assuring that appropriate, effective, and responsible treatments are preserved. Significant relief of neck and back pain, improved quality of life, with restoration of function and return to work, as well as decreased utilization of other healthcare resources is an outcome that should be readily available to patients covered by Medicare. When facet interventions are performed in a disciplined, responsible manner, they achieve outcomes that are clinically, socially, and economically worthwhile 1,2. MEDIAL BRANCH PROCEDURES Medial branch thermal radiofrequency neurotomy (MBTRFN) is a validated treatment for facet joint pain. Long-term follow-up demonstrates that treatment effects are durable and reproducible if symptoms return.3-7 Several systematic reviews have been published that address the body of evidence related to cervical and lumbar medial branch radiofrequency neurotomy.3-6,7, The quality of reviews vary, and we are highlighting significant issues with one high profile Cochrane review in order to illustrate the importance of appreciating technical aspects of the procedures and the importance of patient selection criteria.7 A 2015 Cochrane systematic review by Maas et al poorly serves the needs of payers and patients because it does not consider correct performance or appropriate patient selection for MBTRFN.7 While such reports apply the basic requirements of systematic reviews, their depiction of the evidence is flawed due to lack of insight into these critical clinical practice parameters inherent to the procedures being assessed. The literature on MBTRFN must be meticulously stratified by technique, selection, and outcome. Such a rigorous assessment of the evidence was accomplished in several systematic reviews.3-6 Two of these reviews present the outcomes reported in the literature, stratified by technique and selection criteria, and conclude that effectiveness differs according to how patients are selected and how MBRFN is performed.4,6 The use of single blocks for selection and perpendicular MBRFN technique results in inferior outcomes that may not be greater than sham treatments. In comparison, superior outcomes are evident with the use of two blocks for selection and a parallel MBRFN technique. For a variety of reasons, practitioners use different techniques (e.g. MBTRFN, pulsed RF), yet call their procedures by the same name. These procedures are not the same and must be assessed separately. Likewise, different clinical conditions result in different targets (e.g. medial branch nerves, dorsal root ganglion, sacroiliac joint) and must be assessed separately. Hereafter, our comments focus solely on evidence addressing MBTRFN technique, selection, and outcome. Technique For MBTRFN to have face validity and be capable of achieving the desired outcome, a thermal lesion must be made of sufficient size to cause ablation of a segment of the target nerve. The lesion size, which is influenced by active tip length, cannula diameter, temperature, and lesion time, should be made as large as possible.8,9 Next, the electrode must be accurately placed for the resulting thermal lesion to optimally capture the target nerve. Basic science studies indicate that lesions from perpendicular electrode placements for MBTRFN either fail to reach the target nerve or capture only a small segment, while lesions from parallel electrode placements reliably capture the target nerve and do so along a substantial length of the nerve.1,10-12 Thus, the orientation of the electrode is pivotal to clinical outcome, with perpendicular placements expected to have lower success rates and shorter durations of effect compared to parallel placements with greater success rates for longer periods. Indeed, this is borne out in the literature. This issue is best illustrated by examining the larger evidence base available for lumbar MBRFN (LMBTRFN). Several RCTs do not qualify as providing evidence of efficacy because their active treatment arm lacked face validity by using the insufficient perpendicular technique.13-16 The highly publicized randomized controlled trials by Juch et al13 were irredeemably flawed by study design, patient selection, procedural technique, and data analysis.17-22 The study employed small-gauge electrodes, which generated small lesions. The published images demonstrated that the electrode placements were perpendicular and lateral to the target nerves, and the lesions made by the electrodes would fail to reach the nerves. Censoring these studies leaves only those of Nath 2008, Tekin 2007, and van Kleef 1999 eligible to provide evidence related to the efficacy of LMBTRFN.23-25 These three studies, taken together, provide evidence of significantly beneficial outcomes for patients in terms of pain relief, functional improvement, decreased consumption of analgesics, and improved overall quality of life. Selection Sufficient pain relief following appropriately performed diagnostic medial branch nerve blocks determines patient selection for MBTRFN. Dual comparative medial branch blocks employ two local anesthetics with different durations of action, administered at two different sessions. Patients who obtain relief consistent with the different durations of action of the local anesthetics are considered positive. Dual comparative blocks are advocated as a means of identifying true-positive cases and excluding placebo responders and have been shown to have a sensitivity of 100% and a specificity of 65%.26 Cervical MBTRFN Evidence from high quality systematic reviews supports reliance on dual diagnostic blocks with 100% relief of the index pain to select patients for the procedure.3,4 § More than 60% of patients selected based upon 100% relief of the index pain were pain free at 6 months and nearly 40% were pain free at 1 year with restoration of activities of daily living and no need for other health care for neck pain. 2 § There is no admissible evidence that patients selected based on response to intra-articular blocks or single medial branch blocks will achieve this rate of good outcomes after cervical MBTRFN (CMBTRFN). For patients selected using dual comparative blocks with ≥50% or ≥75% relief of pain: 68% achieve ≥50% relief of pain, 43% achieve ≥80% relief, and 29% achieve complete relief. Thus, patients also see significant benefits even with less restrictive criteria for selection. Lumbar MBTRFN There are different schools of thought within the interventional pain community about whether to rely on a single block with 50% relief or require dual blocks with 80% relief to select patients for LMBTRFN. § 50% Relief, Single Lumbar Medial Branch Block A recently published multisociety consensus guideline advocates for use of at least 50% relief from a single diagnostic block as an appropriate threshold to select patients for LMBTRFN.27 This recommendation prioritizes the optimization of the number of patients who are provided pain relief over the optimization of the treatment success rate. While evidence shows the treatment success rate of LMBTRFN is higher using the more stringent criteria of 80% relief from dual blocks, it also shows that some patients who do not meet this criteria but who do achieve at least 50% relief from a single block can obtain some degree of relief from LMBTRFN. A meta-analysis found that 57% (95% CI: 52-62%) of patients selected on the basis of 50% relief from a single medial branch block and treated with electrodes placed parallel to the target nerve achieved at least 50% relief of pain at 6 months.6 At times, this treatment may be the best available option for patients who have failed more conservative treatments and who wish to avoid the alternative treatments available to them (e.g. opioids, surgery). § 80% Relief, Dual Medial Branch Blocks Conversely 50% pain relief from a single diagnostic block is viewed by some as an unacceptable selection method due to high false-positive rates. Specifically, the single block false-positive rate is between 25-45%, and this is significantly reduced by performance of a second comparative block.28-35 Thus, the recommendation to select patients for LMBTRFN using dual blocks with a higher pain relief threshold prioritizes treatment success in the smaller number of selected patients. Accordingly, the two benchmark studies of LMBTRFN used 80% to 100% relief thresholds following dual comparative local anesthetic blocks and a parallel treatment technique 36,37 – the selection criteria recommended by current LCDs and supported by many physicians and societies. Both studies achieved the best results heretofore reported in the literature. The first study reported 60% of patients maintaining at least 80% relief
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