April 16, 2020 - Revised: 05.20.20

Medicare Administrative Contractors (MACs) Will Host a Multi-jurisdictional Contractor Advisory Committee (CAC) Meeting Regarding Facet Joint and Medial Nerve Branch Procedures on May 28th, 2020 from 1-4 pm CST

Due to the COVID-19 Pandemic the decision has been made to hold the meeting via Teleconference/Webinar ONLY. All other information remains the same.

The purpose of the meeting is to obtain advice from CAC members and subject matter experts (SMEs) regarding the strength of published evidence on Facet Joint and Medial Nerve Branch Procedures. In addition to discussion, the CAC and SME panel will vote on pre-distributed questions. The public is invited to attend as observers.

CAC panels do not make coverage determinations, but MACs benefit from their advice.

The meeting will be hosted by seven Medicare Administrative Contractors.  After closely monitoring the COVID-19 pandemic, it was decided to hold the meeting via teleconference/webinar only.

Complete details are below (background material, questions, agenda, time, and place). Teleconference/webinar link for registration here.

Contractor Medical Directors (CMD) Workgroup

Meredith Loveless, M.D., CGS Administrators, J15
Neil Sandler, MD, CGS Administrators, J15
Leslie Stevens, M.D., First Coast Service Options, JN
Leland Garrett, MD. Palmetto GBA, JJ and JM
Jason Stroud, M.D. Palmetto GBA, JJ and JM
Judith Volkar, M.D., Palmetto GBA, JJ and JM
Marc Duerden, M.D., National Government Services, J6 and JK
Arthur Lurvey, M.D., Noridian Healthcare Solutions, JE and JF
Eileen Moynihan, M.D., Noridian Healthcare Solutions, JE and JF
Leslie Stevens, M.D., Novitas Solutions, Inc., JH and JL
Robert Kettler, M.D., Wisconsin Physician Services Insurance Corporation, J5 and J8

Agenda

1:00-1:15pm	Welcome and Introductions
1:15-1:45pm	Section 1 questions & voting
1:45-2:40pm	Section 2 questions & voting
2:40-3:30pm	Section 3 questions & voting
3:30-4:00pm	Final discussion, questions and closing remarks

Multi-jurisdictional Contractor Advisory Committee (CAC) meeting regarding facet joint and medial nerve branch procedures article list

1. Boswell MV, Manchikanti L, Kaye AD, et al. A Best-Evidence Systematic Appraisal of the Diagnostic Accuracy and Utility of Facet (Zygapophysial) Joint Injections in Chronic Spinal Pain. Pain Physician. 2015;18(4):E497-533.
2. Campos WK, Linhares MN, Sarda J, et al. CATASTROPHIZING PREDICTS THE PAIN RECURRENCE AFTER LUMBAR FACET JOINT INJECTIONS. J Frontiers in Neuroscience. 2019;13:958.
3. Cohen SP, Doshi TL, Constantinescu OC, et al. Effectiveness of lumbar facet joint blocks and predictive value before radiofrequency denervation: the facet treatment study (FACTS), a randomized, controlled clinical trial. J Anesthesiology. 2018;129(3):517.
4. Do KH, Ahn SH, Cho YW, Chang MC. Comparison of intra-articular lumbar facet joint pulsed radiofrequency and intra-articular lumbar facet joint corticosteroid injection for management of lumbar facet joint pain: A randomized controlled trial. Medicine (Baltimore). 2017;96(13):e6524.
5. Juch JN, Maas ET, Ostelo RW, et al. Effect of radiofrequency denervation on pain intensity among patients with chronic low back pain: the mint randomized clinical trials. J Jama. 2017;318(1):68-81.
6. Kennedy DJ, Fraiser R, Zheng P, et al. Intra-articular Steroids vs Saline for Lumbar Z-Joint Pain: A Prospective, Randomized, Double-Blind Placebo-Controlled Trial. Pain Med. 2019;20(2):246-251.
7. Kennedy DJ, Huynh L, Wong J, et al. Corticosteroid injections into lumbar facet joints: a prospective, randomized, double-blind placebo-controlled trial. J American journal of physical 2018;97(10):741-746.
8. Kim BR, Lee JW, Lee E, Kang Y, Ahn JM, Kang HS. Intra-articular facet joint steroid injection–related adverse events encountered during 11, 980 procedures. J European Radiology. 2020;30(3):1507-1516.
9. Kwak DG, Kwak SG, Lee AY, Chang MC. Outcome of intra-articular lumbar facet joint corticosteroid injection according to the severity of facet joint arthritis. Exp Ther Med. 2019;18(5):4132-4136.
10. Lakemeier S, Lind M, Schultz W, et al. A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: a randomized, controlled, double-blind trial. Anesth Analg. 2013;117(1):228-235.
11. Lee CH, Chung CK, Kim CH. The efficacy of conventional radiofrequency denervation in patients with chronic low back pain originating from the facet joints: a meta-analysis of randomized controlled trials. Spine J. 2017;17(11):1770-1780.
12. Manchikanti L. A systematic review and best evidence synthesis of effectiveness of therapeutic facet joint interventions in managing chronic spinal pain. J Pain physician. 2015;18:E535-E582.
13. Manchikanti L, Hirsch JA, Falco FJ, Boswell MV. Management of lumbar zygapophysial (facet) joint pain. World J Orthop. 2016;7(5):315-337.
14. Manchikanti L, Hirsch JA, Kaye AD, Boswell MV. Cervical zygapophysial (facet) joint pain: effectiveness of interventional management strategies. Postgrad Med. 2016;128(1):54-68.
15. Manchikanti L, Sanapati MR, Pampati V, et al. Update of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain from 2000 to 2018 in the US Fee-for-Service Medicare Population. Pain Physician. 2020;23(2):E133-E149.
16. Rambaransingh B, Stanford G, Burnham R. The effect of repeated zygapophysial joint radiofrequency neurotomy on pain, disability, and improvement duration. Pain Med. 2010;11(9):1343-1347.
17. Lee DG1, Ahn SH2, Cho YW1, Do KH3, Kwak SG4, Chang MC1. Comparison of Intra-articular Thoracic Facet Joint Steroid Injection and Thoracic Medial Branch Block for the Management of Thoracic Facet Joint Pain. Spine. 2018 Jan 15;43(2):76-80.
18. Manchikanti L1, Singh V, Falco FJ, Cash KM, Fellows B. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, double-blind, controlled trial with one-year follow. Spine. 2008 Aug 1;33(17):1813-20.
19. Derby R1, Melnik I, Choi J, Lee JE. Indications for repeat diagnostic medial branch nerve blocks following a failed first medial branch nerve block. Pain Physician. 2013 Sep-Oct;16(5):479-88
20. Derby R1, Melnik I, Lee JE, Lee SH. Correlation of lumbar medial branch neurotomy results with diagnostic medial branch lock cutoff values to optimize therapeutic outcome. Pain Med. 2012 Dec;13(12):1533-46. doi: 10.1111/j.1526-4637.2012.01500.x. Epub 2012 Nov 5.

Medicare Administrative Contractors (MACs) will host a Multi-jurisdictional Contractor Advisory Committee (CAC) meeting regarding facet joint and medial nerve branch procedures. The purpose of this meeting is to obtain recommendations regarding zygapophyseal (aka facet) joint injection management of chronic, nonresponsive, and nonmalignant cervical, thoracic, and lumbar spinal pain of facet joint origin to relieve pain and improve functioning in Medicare beneficiaries.

Voting Questions:

For each voting question, please use the following scale identifying your level of confidence – with a score of 1 being low or no confidence and 5 representing high confidence.

Using this scale, please rate your confidence in the clinical literature for each question and cite the literature and rationale for your score. A score of ≥2.5 is considered intermediate confidence that there is robust clinical literature to support the question.

Section One: Procedure Efficacy

This section is to access the evidence for the efficacy of the various facet joint interventions.

1. What is your level of confidence there is robust clinical literature to support the use of diagnostic facet joint injections? Score (1-5): ____
2. What is your level of confidence; there is robust clinical literature to support the use of therapeutic facet joint injections to relieve pain and improve functioning? Score (1-5): ____
3. Does the clinical literature support the use of therapeutic intra-articular facet joint injections as robustly as medial branch block facet joint injections? Score (1-5): ____
4. Does the clinical literature support the safety of repeat facet joint injections with steroids beyond three injections per year? Score (1-5): ____
5. What is your confidence in the clinical literature to support the efficacy of facet joint interventions in each of the following regions?
   1. Cervical Facet (1-5): ____
   2. Lumbar Facet (1-5): ____
   3. Thoracic Facet (1-5): ____

Section 2: Patient Selection

The purpose of this section is to evaluate the evidence to determine who are the right patients for the procedures and criteria can help us determine if patients are selected appropriately.

1. Does the literature support the statement: rigorous beneficiary selection and inclusion criteria are necessary to reduce false-positive diagnoses and/or false-positive error rates when using facet joint injections and procedures?____YES ____NO

The following questions are to access your level of confidence in the clinical literature for each of the following inclusion criteria for consideration of facet joint blocks for Medicare beneficiaries with chronic, axial, nonresponsive, nonmalignant cervical, thoracic, and lumbar spinal pain of facet joint origin:

2. The use of non-specific assessment of subjective "pain reduction" reported by a beneficiary with nonspecific chronic axial spine pain (not associated with radiculopathy or myelopathy) is a reliable and valid measure of improvement in pain following a facet injection or medial branch block injection? Score (1-5): ____
3. Do you have intermediate confidence (≥2.5) that there is adequate clinical literature to support a minimal numeric "pain level" (Numerical Rating Scale [NRS], visual analog score [VAS] or similar) threshold (i.e., 6/10) to identify an individuals' pain level before a Medicare beneficiary is eligible for a facet joint injection or procedure? ____YES ____NO
   1. If Yes, what scoring system and the minimal score best supported by the literature?
4. If the answer to the above question is no, do you have at least intermediate confidence (≥ 2.5) the evidence support that inclusion criteria terminology indicate that the Medicare beneficiary's chronic, nonresponsive, and nonmalignant spinal pain be documented to be severe enough to cause some degree of moderate to severe functional deficit? ____YES ____NO
   
   If yes, how does the evidence best define functional deficit?
   
   
5. Does the clinical literature support conservative treatment for a minimum of 3 months as a prerequisite before facet injections and/or medial branch block injections? Score (1-5): ____
6. Do you agree the following modalities are considered conservative treatment?
   1. Integrative treatments (such as acupuncture and spinal manipulation) ____YES ____NO
   2. Physical treatments (usually through physical therapy and include exercise, heat and cold modalities, massage) ____YES ____NO
   3. Medications (such as NSAIDs, antidepressants) ____YES ____NO
   4. Others (nutrition, weight loss, sleep hygiene) ____YES ____NO
7. Does the clinical literature support the use of inclusion criteria for facet blocks for with subjective chronic axial spine pain of greater than three months duration? Score (1-5): ____
8. Does the clinical literature support at least intermediate confidence (≥ 2.5) that history and physical examination can be used to identify a painful facet joint as the primary source of pain? ____YES ____NO
9. Does the clinical literature support with at least intermediate confidence (≥ 2.5) a requirement for imaging before prognostic blocks? ____YES ____NO
   
   If yes, what imaging studies are best supported in the literature?
10. Does the clinical literature support with at least intermediate confidence (≥ 2.5) objective documentation (e.g., a daily pain diary) should be required to measure the sustained percentage of improvement following facet joint injections to relieve pain and improve function? ____YES ____NO
11. I am confident that there is at least intermediate confidence (≥ 2.5) in the clinical literature to support the terminology of temporary pain relief, long-lasting pain relief, and permanent pain relief is a reasonable, reliable, and meaningful health outcome terms to provide an objective clinical assessment for facet-mediated pain relief? ____YES ____NO
12. Does the clinical literature support the definitions for the following terms?
    
    
    1. Temporary pain relief is defined as pain relief greater than 80% based on the minimum duration of action/relief consistent with the local anesthetic agent employed during the therapeutic zygapophyseal joint injection procedure and/or medial branch blocks? ____YES ____NO
       
       If NO, what percentage would the literature recommend?
       
       
    2. Long-lasting pain relief is defined as pain relief consistent greater than 50% pain relief for at least twelve (12) weeks from the prior therapeutic zygapophyseal joint injection procedure and/or medial branch blocks ____YES ____NO
       
       If NO, what duration of weeks would the literature support?
       
       
    3. Permanent pain relief is defined as pain relief consistent greater than 50% pain relief for at least twenty-six (26) weeks from the prior therapeutic zygapophyseal joint injection procedure and/or medial branch blocks ____YES ____NO
       
       If NO, what duration of weeks would the literature support?
       
       
13. Please rank your confidence in the clinical literature to support exclusion criteria for facet joint procedures:

    a. I have at least intermediate confidence (≥ 2.5) that there is clinical literature to support that a Medicare beneficiary with mild pain or mild functional deficits should not be treated with facet joint procedure? ____YES ____NO

    b. I have at least intermediate confidence (≥ 2.5) that there is not sufficient clinical literature to support the use of zygapophyseal joint injection procedures for the management of spinal pain in Medicare beneficiaries with clinical findings of centralized pain syndrome(s) with widespread diffuse pain? ____YES ____NO
    
    If no, I have at least intermediate confidence (≥ 2.5) that there is clinical literature to support that a physician must include a rigorous beneficiary evaluation and apply selection criteria to those Medicare beneficiaries with centralized pain syndrome(s) with widespread diffuse pain before the use of providing zygapophyseal joint injection procedures for the management of chronic, axial, nonresponsive, and nonmalignant spinal pain. ____YES ____NO
    
    If yes, what criteria are supported?
    

14. Is there clinical evidence to support additional inclusion or exclusion criteria? ____YES ____NO
    

Section 3: Procedure Related Questions

1. What is your level of confidence (1-5) based on the clinical literature to support that the following procedures should not be used in the same or close location and in conjunction with a zygapophyseal joint injection procedure to reduce false-positive diagnoses and/or false-positive error rates in Medicare beneficiaries with spinal pain of facet joint origin?
   1. Trigger point injections Score (1-5): ____
   2. Epidural injections Score (1-5): ____
   3. SI joint injections Score (1-5): ____
   4. Selective nerve root blocks Score (1-5): ____
   5. Sympathetic ganglion blocks Score (1-5): ____
   6. Other injections, celiac plexus blocks, trigeminal nerve blocks, etc. Score (1-5): ____
2. I am confident that there is clinical literature to support the use of a series of two (2) medial branch blocks [MBBs] are needed to diagnose facet pain and establish consistency of test results due to high false-positive rate of a single MBB injection? Score (1-5): ____

   1. a. What is your level of confidence the clinical literature supports the use of two (2) medial branch blocks [MBBs] test results need to have objective documentation (e.g., a pain diary) to support the Medicare beneficiary had a minimum of 80% temporary pain relief of first and second MBB pain levels (with the duration of relief being consistent with the agent used) or objective documentation (i.e., a pain diary) to support a minimum of at least 50% sustained improvement in pain and the ability to perform previously painful movements and ADLs? Score (1-5): ____

3. What is your level of confidence based on the clinical literature to support subsequent therapeutic intraarticular injections or medial branch blocks at the previously injected facet joints or medial branch blocks (i.e., the same anatomic site) are effective to reduce pain and improve function? Score (1-5): ____
   1. What is your level of confidence based on the clinical literature if the subsequent facet joint intraarticular injections or medial branch blocks need to have objective documentation (e.g., a pain diary) to show a minimum of 80% sustained relief of the first and second MBB pain levels (with the duration of relief being consistent with the agent used)? Score (1-5): ____
   2. What is your level of confidence based on the clinical literature if the subsequent facet joint intraarticular injections or medial branch blocks need to have objective documentation (e.g., a pain diary) to support a minimum of at least 50% sustained improvement in pain and in the ability to perform previously painful movements and ADLs for at least three months? Score (1-5): ____
4. What is your level of confidence based on the clinical literature regarding the frequency of repeat injections?
   1. Diagnostic injections should be a minimum of 28 days apart? Score (1-5): ____
   2. Therapeutic injections should be a minimum of 3 months apart? Score (1-5): ____
   3. Interventional procedures at different regions should be performed a minimum of 2 weeks apart? Score (1-5): ____
   4. In the treatment phase, interventional procedures should be repeated only if medically necessary and not to exceed four times in one year? Score (1-5): ____
   5. For facet joint neurolysis frequency would be only of medically necessary at a minimum of 6 months apart? Score (1-5): ____
5. What is your confidence in the clinical literature to support facet injection or medial branch blocks being allowed for three (3) spinal levels per anatomic regions (diagnostic or therapeutic) in one session? Score (1-5): ____
6. What is your level of confidence (1-5) the clinical literature supports that when subsequent thermal medial branch radiofrequency neurotomies at the same anatomic site are considered medically reasonable and necessary if the facet joint denervation has objective documentation (e.g., a pain diary) to show a minimum of 80% from diagnostic injections (with the duration of relief being consistent with the agent used) or objective documentation (e.g., a pain diary) to show a minimum of at least 50% sustained improvement in pain and in the ability to perform previously painful movements and ADLs for at least six months. Score (1-5): ____
   1. Does the literature support repeat imaging for repeat thermal medial branch radiofrequency neurotomies? Score (1-5): ____
   2. Does the literature support a requirement to have repeat diagnostic injections prior to repeating thermal medial branch radiofrequency neurotomies? Score (1-5): ____
7. Are there any evidence-based strategies to improve the safety and reduce complications associated with facet joint injections and procedures? ____YES ____NO
8. What is your confidence in the clinical literature to support a limitation of injection volume <0.5 ml for medical branch block and volumes <1.5ml for intraarticular injections? Score (1-5): ____
9. What is your confidence in the clinical literature to support that facet joint interventions (diagnostic or therapeutic) must be performed under fluoroscopic or CT guidance? Score (1-5): ____
10. What is your confidence that there is sufficient clinical literature to support facet joint interventions (diagnostic or therapeutic) can be performed under ultrasound guidance? Score (1-5): ____
11. What is your confidence based on the clinical literature to support to use of a facet joint cyst rupture to provide facet mediated pain relief? Score (1-5): ____
12. What is your confidence based on existing literature in the placement of intrafacet implants? Score (1-5): ____