To: Manuel Suarez, M.D. Medical Director Neighborhood Health Plan Management Department 5757 Plaza Dr. Cyprus, CA Mailstop: CA

Transcription

1 To: Manuel Suarez, M.D. Medical Director Neighborhood Health Plan Management Department 5757 Plaza Dr. Cyprus, CA Mailstop: CA Subject: Denial of Cervical Spinal Injection Procedures Dear Dr. Suarez, This letter is in reference to Neighborhood Health Plans Policy regarding the denial of cerivical spinal injections. Specifically, Neighborhood has developed draconian guidelines which have caused the denial of cervical facet and epidural injections. Specifically, we have received feedback from our membership with regard to the treatment of chronic cervical pain: 1. Cervical epidural injections are denied based on lack of evidence 2. Cervical facet injections limited to one set per lifetime 3. Cervical medial branch nerve blocks are denied Please read the attached Epidural Position Statement which was written by the Florida Society of Interventional Pain Physicians (FSIPP) and recently presented to the Surgeon General of Florida. This position statement was based on rigorous evidence-based guidelines developed by the American Society of Interventional Pain Physicians (ASIPP). In addition, I have included references from Official Disability Guidelines and AHRQ guidelines regarding cervical epidural and facet injections. Interlaminar Epidural Injections (ASIPP analysis) The indicated evidence for cervical interlaminar epidural steroid injections is Level II Benyamin RM, Singh V, Parr AT, Conn A, Diwan S, Abdi S.; Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain. Pain Physician Jan-Feb;12(1):

2 Official Disability Guidelines (ODG) Epidural steroid injection (ESI) Recommended as an option for treatment of radicular pain (defined as pain in dermatomal distribution with corroborative findings of radiculopathy). See specific criteria for use below. In a recent Cochrane review, there was one study that reported improvement in pain and function at four weeks and also one year in individuals with chronic neck pain with radiation. (Peloso-Cochrane, 2006) (Peloso, 2005) Other reviews have reported moderate short-term and long-term evidence of success in managing cervical radiculopathy with interlaminar ESIs. (Stav, 1993) (Castagnera, 1994) Some have also reported moderate evidence of management of cervical nerve root pain using a transforaminal approach. (Bush, 1996) (Cyteval, 2004) A recent retrospective review of interlaminar cervical ESIs found that approximately two-thirds of patients with symptomatic cervical radiculopathy from disc herniation were able to avoid surgery for up to 1 year with treatment. Success rate was improved with earlier injection (< 100 days from diagnosis). (Lin, 2006) These reports were in contrast to a retrospective review of 1,036 injections that showed that there were no catastrophic complications with the procedure. (Ma, 2005) The American Academy of Neurology recently concluded that epidural steroid injections may lead to an improvement in radicular lumbosacral pain between 2 and 6 weeks following the injection, but they do not affect impairment of function or the need for surgery and do not provide long-term pain relief beyond 3 months, and there is insufficient evidence to make any recommendation for the use of epidural steroid injections to treat radicular cervical pain. (Armon, 2007) There is evidence for shortterm symptomatic improvement of radicular symptoms with epidural or selective root injections with corticosteroids, but these treatments did not appear to decrease the rate of open surgery. (Haldeman, 2008) (Benyamin, 2009) Epidural steroid injections should be reserved for those who may otherwise undergo open surgery for nerve root compromise. (Bigos, 1999) Intramuscular injection of lidocaine for chronic mechanical neck disorders (MND) and intravenous injection of methylprednisolone for acute whiplash were effective treatments. There was limited evidence of effectiveness of epidural injection of methyl prednisolone and lidocaine for chronic MND with radicular findings. (Peloso-Cochrane, 2006) AHRQ Guidelines What is the role of epidural steroid injections for the treatment of cervical radiculopathy from degenerative disorders? Transforaminal epidural steroid injections using fluoroscopic or CT guidance may be considered when developing a medical/interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to the potential complications. Grade of Recommendation: C (limited or poor quality studies) This level of evidence is specific for cervical transforaminal epidural steroid injections, because there is a lack of high level studies (level 1-2). However, AHRQ does not state "not recommended". The interventional pain management community is well aware of the risks associated with cervical transforaminal epidural steroid injections.

3 With regard to interlaminar epidural steroid injections however, the recommendations are positive and the level of evidence is high. Cervical Facet Injections Medial Branch Blocks The medial branch facet nerve innervated the facet joint. It is typically block with a very small (< 1 ml) of local anesthetic outside of the facet joint. It is not an intraarticular injection. Based on Guyatt et al s criteria 2 (Table 1) the recommendation is strong (1B or 1C) for the use of therapeutic cervical, thoracic, and lumbar facet joint nerve blocks to provide both short-term and long-term relief in the treatment of chronic facet joint pain. The evidence for diagnosis of cervical facet joint pain is Level I or II-1 based on the USPSTF criteria (Table 2). 3 Intraarticular Facet Injections The evidence for cervical intraarticular injections is lacking. There was no evidence available for thoracic intraarticular facet joint injections. Recommendations Based on the present comprehensive evaluation (ASIPP) 4 diagnostic cervical facet joint nerve blocks are recommended in patients with the following criteria: Patients suffering with somatic or non-radicular neck pain or headache and upper extremity pain, with duration of pain of at least 3 months. Average pain levels of greater than 6 on a scale of 0 to 10. Pain is at least intermittent or continuous causing functional disability. Problem has failed to respond and has not resolved with more conservative management, including physical therapy modalities with exercises, chiropractic management, and non-steroidal antiinflammatory agents. Lack of preponderance of evidence of discogenic pain, disc herniation, or evidence of radiculitis. There is no evidence of contraindications for the needle placement and injection of local anesthetics. Contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate non-steroidal anti-inflammatory drugs. A positive response is based on the following evidence: Patient has met the above indications. Patient responds positively to controlled local anesthetic blocks either with placebo control or comparative local anesthetic blocks with appropriate response to each local anesthetic with < 1 ml of local anesthetic. 2 Guyatt G, Gutterman D, Baumann MH, Addrizzo-Harris D, Hylek EM, Phillips B, Raskob G, Lewis SZ, Schünemann H. Grading strength of recommendations and quality of evidence in clinical guidelines. Report from an American College of Chest Physicians task force. Chest 2006; 129: Berg AO, Allan JD. Introducing the third U.S. Preventive Services Task Force. Am J Prev Med 2001; 20:S3-S4. 4 Laxmaiah Manchikanti, MD et al; Comprehensive Evidence-Based Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain; Pain Physician 2009; 12:

4 At least 80% relief as criterion standard with ability to perform previously painful movement without deterioration of the relief (i.e., extension, overhead activity, lateral rotation, flexion, etc.). The patient s response should be recorded independently by the assessor - generally a registered nurse familiar with patient or another physician. Cervical Medial Branch Neurotomy Based on USPSTF criteria, the indicated evidence for cervical medial branch radiofrequency neurotomy is Level II-1 to Level II-2, Level II-2 to II-3 for lumbar radiofrequency neurotomy. Based on Guyatt et al s criteria for cervical radiofrequency neurotomy and lumbar radiofrequency neurotomy, the recommendation is 1C/strong recommendation. AHCR The treatment is chronic cervical pain under AHCR guidelines defers to ASIPP guidelines 5. Official Disability Guidelines (ODG) Facet joint diagnostic blocks Recommended prior to facet neurotomy. Diagnostic blocks are performed with the anticipation that if successful, treatment may proceed to facet neurotomy at the diagnosed levels. Current research indicates that a minimum of one diagnostic block be performed prior to a neurotomy, and that this be a medial branch block (MBB). Although it is suggested that MBBs and intra-articular blocks appear to provide comparable diagnostic information, the results of placebo-controlled trials of neurotomy found better predictive effect with diagnostic MBB. In addition, the same nerves are tested with the MBB as are treated with the neurotomy. The use of a confirmatory block has been strongly suggested due to the high rate of false positives with single blocks (range of 27% to 63%) but this does not appear to be cost effective or to prevent the incidence of false positive response to the neurotomy procedure itself. Technique: The described technique of blocking the medial branch nerves in the C3-C7 region (C3-4, C4-5, C5-6, and C6-7) is to block the named medial branch nerves (two injections). Authors have described blocking C2-3 by blocking the 3 rd occipital nerve. Another technique of blocking C2-3 is to block at three injection points (vertically over the joint line, immediately above the inferior articular facet at C2 and immediately below the superior articular facet at C3). (Barnsley, 1993) The medial branch nerve innervates the facet joint, facet capsular ligaments, the interspinous and supraspinous ligaments, spinous processes and paraspinal muscles. Relief of pain could be due to blockade of nociceptive input from any combination of these. It is suggested that the volume of injectate for diagnostic medial branch blocks be kept to a minimum (a trace amount of contrast with no more than 0.5 cc of injectate) as increased volume may anesthetize these other potential areas of pain generation and confound the ability of the block to accurately diagnose facet pathology. A recent study has recommended that the volume be limited to 0.25 cc. Epidemiology of involved levels: Using cadaver evidence facet arthrosis most commonly affects the upper cervical levels, and increased with age, and was very rare in patients less than 40 years of age. C4-5 is the most common level followed by C3-4 and C2-3. This study did not attempt to identify number of levels of involvement. (Lee, 2009) Number of levels of involvement: In a randomized controlled trial of therapeutic cervical medial branch blocks it was stated that 48% of patients had 2 joints involved and 52% had three joints involved. (Manchikanti, 2008) These levels were identified by the pain pattern, local or paramedian tenderness over the area of the facet joint, and reproduction of pain to deep pressure. (Manchikanti, 2004) Other prevalence studies from this group also indicated that the majority of patients with cervical involvement were treated at three joints. Target joints were identified as noted above. (Manchikanti, 2004). There are no studies that have actually tested levels of 5 Manchikanti L, et al; An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations Pain Physician 2009 Jul-Aug;12(4):

5 involvement using individual injections for diagnostic verification. Criteria for the use of diagnostic blocks for facet nerve pain: ODG Clinical presentation should be consistent with facet joint pain, signs & symptoms. 1. One set of diagnostic medial branch blocks is required with a response of 70%. The pain response should be approximately 2 hours for Lidocaine. 2. Limited to patients with cervical pain that is non-radicular and at no more than two levels bilaterally. 3. There is documentation of failure of conservative treatment (including home exercise, PT and NSAIDs) prior to the procedure for at least 4-6 weeks. 4. No more than 2 joint levels are injected in one session (see above for medial branch block levels). 5. Recommended volume of no more than 0.5 cc of injectate is given to each joint, with recent literature suggesting a volume of 0.25 cc to improve diagnostic accuracy. 6. No pain medication from home should be taken for at least 4 hours prior to the diagnostic block and for 4 to 6 hours afterward. 7. Opioids should not be given as a sedative during the procedure. 8. The use of IV sedation may be grounds to negate the results of a diagnostic block, and should only be given in cases of extreme anxiety. 9. The patient should document pain relief with an instrument such as a VAS scale, emphasizing the importance of recording the maximum pain relief and maximum duration of pain. The patient should also keep medication use and activity logs to support subjective reports of better pain control. 10. Diagnostic facet blocks should not be performed in patients in whom a surgical procedure is anticipated. 11. Diagnostic facet blocks should not be performed in patients who have had a previous fusion procedure at the planned injection level. 12. It is currently not recommended to perform facet blocks on the same day of treatment as epidural steroid injections or stellate ganglion blocks or sympathetic blocks or trigger point injections as this may lead to improper diagnosis or unnecessary treatment To summarize: Cervical epidural steroid injections are effective for the treatment of chronic cervical pain secondary to radiculopathy, degenerative disease or disc herniations. They have been demonstrated to reduce the need for cervical intervention. Cervical intra-articular facet injections lack significant evidence. However, cervical medial branch nerve blocks demonstrate strong evidence for the diagnosis of cervical pain. Subsequent cervical medial branch neurotomy (through radiofrequency, etc.} demonstrate strong evidence for the treatment of

6 chronic cervical pain. Therapeutic cervical medial branch blocks also demonstrate relatively strong evidence for the treatment of chronic cervical pain It should be pointed out that the CPT code for both cervical intra-articular facet injections and medial branch blocks is the same; Therefore, if you are denying intra-articular facet injections based on the CPT code, then you are inappropriately denying cervical medial branch nerve blocks as well. We therefore believe that your analysis is flawed in denying both cervical epidural steroid injections and facet injections. The claim that Neighborhood has made that there is insufficient evidence to justify these procedures is a direct contradiction to major evidence-based guidelines that have been developed. I would appreciate any communication regarding your decision with respect to cervical epidural steroid injections or any other interventional pain management procedure. Sincerely, Sanford M. Silverman, M.D. President, Florida Society of Interventional Pain Physicians

7 Table 1- Level of Evidence based on Guyatt et al. Table 2 - Adapted from U.S. Preventive Services Task Force (USPSTF)