ࡱ> '` bjbj >*&1***>8¢fT>&eƩƩ"```ccccccc$ghnil?c*^?cdKKK8*cKcKK:,*W pYL  J4d0&e).iiWWBi*L_`rKr\ο```?c?c^```&e>>f$>>f>>> December 28, 2009 Lonny Reisman, MD Senior Vice President and Chief Medical Officer Aetna, Inc. 151 Farmington Avenue Hartford, CT 06156 Re: Clinical Policy Bulletin: Back Pain Invasive Procedures, Number: 0016 Dear Dr. Reisman: On behalf of the American Society of Interventional Pain Physicians (ASIPP), we would like to thank you for publishing updated guidelines for invasive procedures. Since these guidelines have elicited significant confusion and the society has received multiple requests to comment. On behalf of the ASIPP Board and membership, the Executive Committee would like to provide comments for your clinical policy bulletin to be able to provide these procedures appropriately and also maintain access to patients insured by Aetna. ASIPP is a not-for-profit professional organization comprised of nearly 4,000 interventional pain physicians and other practitioners who are dedicated to ensuring safe, appropriate and equal access to essential pain management services for patients across the country suffering with chronic and acute pain. There are approximately 7,000 physicians practicing interventional pain management in the United States. Interventional pain management is defined as the discipline of medicine devoted to the diagnosis and treatment of pain related disorders principally with the application of interventional techniques in managing sub acute, chronic, persistent, and intractable pain, independently or in conjunction with other modalities of treatment.1 Interventional pain management techniques are minimally invasive procedures, including percutaneous precision needle placement, with placement of drugs in targeted areas or ablation of targeted nerves; and some surgical techniques such as laser or endoscopic diskectomy, intrathecal infusion pumps and spinal cord stimulators, for the diagnosis and management of chronic, persistent or intractable pain.2 I. MEDICALLY NECESSARY PROCEDURES 1. FACET JOINT INJECTIONS: The confusion starts with a set of facet joint injections means up to 6 injections per sitting which can be repeated up to 4 times to establish the diagnosis and achieve therapeutic effect. Policy also states limited to 2 sets in 3 years. Up to 6 injections is too many and it only increases waste, abuse, and fraud. As you are aware, OIG report3 evaluating 2006 Medicare facet joints showed to have paid over $2 billion in 2006 for interventional pain management procedures. The report also showed that Medicare payments for facet joint injections increased from $141 million in 2003 to $307 million in 2006. Further, 63% of facet joint injection services allowed by Medicare in 2006 did not meet Medicare program requirements, resulting in approximately $130 million in improper payments for physicians and facilities. This report illustrated that facet joint injection services provided in an office were more likely to have an error than those provided in an ambulatory surgery center or hospital outpatient department. The OIG report also illustrated that 35% of Medicare facet joint injections were performed by non-interventional pain physicians; 19% by general practitioners, internists, and family practice physicians; while the remaining 16% were performed by orthopedic surgeons, neurologists, and rheumatologists. Manchikanti et al4 showed that overall interventional techniques increased significantly in Medicare beneficiaries. They also showed that the proportion of patients receiving interventional pain management services per 100,000 Medicare population increased by 137%, the number of visits increased by 144%, and services increased 197%. The increases were 117% in Medicare patients for epidural procedures from 1997 to 2006, whereas for facet joint inventions, the increases were 624%, along with a 596% increase for spinal cord stimulation, with a total increase of 197%. There were significant geographic differences noted with a 11.6-fold difference (431% vs. 37% increase) between Florida and California in 2006. The differences were also significant in that patients under 65 years of age showed an increase of 504% per 100,000 Medicare population compared to 355% for those over 65 years for facet joint injections. Utilization of facet joint interventions by specialties was very interesting; overall a 122% increase was seen for interventional pain management professionals (anesthesiology, pain management, neurology, neurosurgery, orthopedic surgery, physical medicine and rehabilitation, and psychiatry), the increases were 398% for nurse practitioners and CRNAs, and 1,109% for general physicians (general practice, family, and internal medicine), giving a 100% annual increase for nurse practitioners and CRNAs and 277% annual increase for general physicians. The fluoroscopy utilization was also based on the specialty with an increase seen in all specialties, but with lowest utilization of fluoroscopy was by general physicians. Thus, fluoroscopy was utilized by 86% of the pain physicians and only 19% of general physicians with an overall utilization of fluoroscopy in 63% of the patients. Some of these may be addressed with the new codes which incorporate fluoroscopy and limit injections to a maximum of 3 per region (CPT 64490, 64491, 64492 for cervical and thoracic; CPT 64493, 64494, 64495 for lumbar). 1.1 Diagnostic Medial Branch Blocks The role of controlled diagnostic blocks in the diagnosis of facet joint pain has been described in multiple publications.5-8 It has been established that the diagnosis can only be furnished appropriately with 80% pain relief with concordant duration based on the local anesthetic injected with comparative local anesthetic blocks or placebo controlled blocks with ability to perform previously painful movements. ASIPP guidelines9 published in July/August 2009 utilized a comprehensive review process. Based on the systematic review by Datta et al8 utilizing 7 studies meeting inclusion criteria with 80% pain relief and ability to perform previously painful movements with controlled diagnostic blocks of lumbar facet joint nerves showed evidence of Level I or II-1 based on the United States Preventive Services Task Force (USPSTF) criteria.10 Similarly Falco et al7 utilizing similar criterial of 80% relief with controlled diagnostic blocks with ability to perform previously painful movements utilized 9 studies meeting inclusion criteria and showed Level I or II-1 evidence based on the USPSTF criteria. Atluri et al6 utilizing 3 studies showed Level II-1 evidence based on USPSTF criteria. Validity of facet joint nerve blocks in the diagnosis of facet joint pain has been established with multiple variables including with establishment of long-term follow-up,11,12 influence of sedation,13-17 psychological variables,18,19 opioid intake,20 and post-surgery.21,22 Further, Rubinstein and van Tulder23 in a best-evidence review of diagnostic procedures for low-back pain concluded that there is strong evidence for the diagnostic accuracy of facet joint nerve blocks. In summary, the 3 systematic reviews showed prevalence of lumbar facet joint pain in 21% to 40% in heterogenous population with chronic low back pain and 16% in post-lumbar surgery syndrome with an overall prevalence of 31%8 (Table 1), 36% to 67% in patients with chronic neck pain with an average prevalence of 49%7 (Table 2), and 34% to 42% in patients with chronic thoracic pain6 (Table 3). These studies also showed false-positive rates of 17% to 49% with an overall false-positive rate of 30% in the lumbar spine,8 27% to 63% in the cervical spine with an average of 49%,7 and 42% to 55% in the thoracic spine.6 We agree with the evaluation of intraarticular facet joint injections that there is not significant literature however, the reviews quoted are flawed and biased from the American College of Occupational and Environmental Medicine which is not peer reviewed24 and Chou et al25 which are also not current. The extensive criticism has been provided for ACOEM guidelines. The Cochrane review by Staal et al26 is also incomplete. The inclusion criteria by these 3 reviews is deficient, inconsistent methodology of review of individual articles and quality assessment was deficient and biased without understanding the clinical parameters. The above mentioned systematic reviews and ASIPP guidelines clearly describe these deficiencies. Table 1. Data of prevalence with controlled diagnostic blocks and false-positive rates in the lumbar region. Study Methodological Criteria *ParticipantsPrevalenceFalse-Positive RateManchikanti et al 2002277512040% (95% CI 31%49%)30% (95% CI 20%40%)Manchikanti et al 200428 7539731% (95% CI 27%36%)27% (95% CI 22%32%)Manchukonda et al 2007297530327% (95% CI 22%33%)45% (95% CI 36%53%)Schwarzer et al 1995 #30 756340% (95% CI 29%53%)NAManchikanti et al 2001317512040% (95% CI 31%49%)47% (95% CI 35%59%)Manchikanti et al 200332 75300I. 21% (95% CI 14%27%) II. 41% (95% CI 33%49%)I. 17% (95% CI 10%24%) II. 27% (95% CI 18%36%)Manchikanti et al 2007227511716% (95% CI 9%23%)49% (95% CI 39%59%)Overall 1,42031% (95% CI; 28%33%)30%# (95% CI; 27%33%)CI = confidence interval; NA =not available; # Schwarzer et al30 was without evaluation of false-positive rates. *Methodologic quality assessment adapted and modified from West S et al. Systems to Rate the Strength of Scientific Evidence, Evidence Report, Technology Assessment No. 47. AHRQ Publication No. 02-E016. Source: Datta S et al. Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions. Pain Physician 2009; 12:437-460.8 Table 2. Data of prevalence and false-positive rates of cervical diagnostic facet joint blocks. Study Methodologic Criteria # of Subjects Prevalence Estimates False-Positive Rate Barnsley et al 199533755054% (95% CI, 40%, 68%).NABarnsley et al 1993347555NA27% (95% CI, 15%, 38%)Lord et al 199635756860% (95% CI, 46%, 73%)NAManchikanti et al 200227 7512067% (95% CI, 58%,75%)63% (95% CI 48%, 78%)Manchikanti et al 20042875255 of 50055% (95% CI, 49%, 61%)63% (95% CI 54%, 72%)Manchukonda et al 20072965251 of 50039% (95% CI, 32%, 45%)45% (95% CI 37%, 52%)Manchikanti et al 20082165Non-Surgery: 206 Post-Surgery: 45Non-Surgery 39% (95% CI, 33%, 46%) Post-Surgery 36% (95% CI, 22%, 51%)Non-Surgery 43% (95% CI 35%, 52%) Post-Surgery 50% (95% CI 32%, 68%)Speldewinde et al 200136509736% (95% CI, 27%, 45%)NAYin and Bogduk 2008376084 of 14342%# (95% CI, 31%, 52%)NAOVERALL 98049% (95% CI, 45%, 52%)49% (95% CI, 44%, 54%)# Authors reported adjusted prevalence as 55% (95% CI, 38%, 62%) and crude prevalence as 24%. NA = not available or not applicable; CI = confidence interval Source: Falco FJE et al. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician 2009; 12:323-344.7 Table 3. Data of prevalence with controlled diagnostic blocks and false-positive rates in thoracic region. Study Methodological Quality Scoring (AHRQ) Participants Prevalence False-Positive Rate Manchikanti et al 20023870 46 48% (95% CI 34%62%) 58% (95% CI 38%78%) Manchikanti et al 20042870 72 42% (95% CI 30%53%) 55% (95% CI 39%78%) Manchukonda et al 20072960 65 34% (95% CI 22%47%) 42% (95% CI 26%59%) COMBINED RESULTS (AVERAGE) 173 40% (95% CI 33%-48%) 42% (95% CI 33%51%) AHRQ=Agency for Healthcare Research and Quality; CI = confidence interval Source: Atluri S et al. Systematic review of diagnostic utility and therapeutic effectiveness of thoracic facet joint interventions. Pain Physician 2008; 11:611-629.6 1.2 Therapeutic Medial Branch Blocks The evidence assessment for medial branch blocks was recently published in ASIPP guidelines with 3 systematic reviews6-9,39 evaluating the effectiveness of therapeutic facet joint nerve blocks (Table 4). The previous systematic reviews by ACOEM,24 Chou et al,25 and Staal et al26 are not only outdated, but also they have failed to utilize appropriate criteria meeting inclusion. Thus, ASIPP guidelines and the 3 systematic reviews are superior in consideration of the evidence and utilization of sound methodology. Further, additional evidence which has been available since the publication of these guidelines and systematic reviews also confirms the analysis with 2-year follow-up. Table 4. Results of published reports of effectiveness of cervical, thoracic, and lumbar medial branch blocks. Study Study Characteristics Methodological Quality Score(s) No. of Patients 3 mos.Long-term ReliefResults 6 mos. 12 mos. Short-term relief d" 6 mos. Long-term relief > 6 mos.CERVICALManchikanti et al 200840RA, DB 76 76 83% vs 85% 87% vs 95% 85% vs 92% P P Manchikanti et al 200441O 69 100 92% 82% 56% P P THORACICManchikanti et al 200842RA, DB 60 Group I - no steroid=24 Group II - steroid=24 79% vs 83% 79% vs 81% 79% vs 79% P P Manchikanti et al 200643O 69 55 71% 71% 76% P P LUMBARManchikanti et al 200844RA, DB 73 Group I - no steroid = 60 Group II - steroid = 60 83% vs 82% 83% vs 93% 82% vs 85% P P Manchikanti et al 200145RA 59 73 100% 82% 21% P P RA = randomized; DB = Double-blind; O = observational; vs = versus; P = positive; N = negative Source: Falco FJE et al. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician 2009; 12:323-344.7 Atluri S et al. Systematic review of diagnostic utility and therapeutic effectiveness of thoracic facet joint interventions. Pain Physician 2008; 11:611-629.6 Datta S et al. Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions. Pain Physician 2009; 12:437-460.8 It is essential for the methodologists and clinicians to accurately follow the requirements of evidence-based medicine in conducting systematic reviews of diagnostic accuracy studies which was deficient in all 3 reviews by ACOEM,24 Chou et al,25 and Staal et al.26 The systematic reviews and ASIPP guidelines utilized 4 randomized trials evaluating the effectiveness of facet joint nerve blocks and meeting the inclusion criteria utilizing active control design.6-9 These studies are referred to as non-inferiority or equivalence trials, consequently, they lack placebo. However, active control design show the existence of effect and compare the therapies comparative effectiveness which is promoted in the United States. These studies also were conducted based on consolidated standards of reporting trials (CONSORT) criteria.46 All the studies except the earliest one45 were double-blind, randomized, and controlled trials with inclusion of outcome assessments with numeric pain scores, Oswestry or Neck Pain Disability Index, opioid intake, and work status reported at baseline, 3 months, 6 months, and 12 months. Twenty-four month data is also under consideration for publication for cervical medial branch blocks and lumbar facet joint nerve blocks, however, the study on thoracic medial branch blocks has not been completed yet. In these studies, they considered significant relief as 50% or greater and significant functional status improvement as 40% or more robust measures. The inclusion criteria involved confirmation of the existence of facet joint pain based on 80% relief with controlled local anesthetic blocks. All the studies showed positive results with 71% to 90% of the patients showing positive results on a long-term basis of one-year for thoracic facet joint blocks and 2 years for cervical and lumbar facet joint nerve blocks. As touted by many, the limitations of these studies include lack of placebo, non-academic setting, and single-center studies. The same authors also published prospective studies which have been mentioned before, however, results of randomized studies were shown to be superior. The cost-effectiveness of lumbar facet joint nerve blocks was also evaluated45 with one-year improvement of quality of life at $3,461 which was superior to multiple other treatments. Consequently, the 3 systematic reviews concluded that the indicated level of evidence based on USPSTF criteria10 for lumbar, thoracic, and cervical facet joint nerve blocks as Level II-1 or II-2. They also yielded based on Guyatt et als criteria47 the recommendation as 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. Thus, we believe that facet joint nerve block effectiveness was not appropriately evaluated. 1.3 Radiofrequency Facet Denervation We agree that success rate depends on careful selection and appropriate technique. The evidence by 3 systematic reviews and ASIPP guidelines,6-9 based on USPSTF criteria,10 showed Level II-1 to Level II-2 for cervical medial branch radiofrequency neurotomy, and Level II-2 to II-3 for lumbar radiofrequency neurotomy, with and with no evidence available for thoracic medial branch radiofrequency neurotomy. (Table 5) Table 5. Published results of studies of cervical and lumbar facet joint nerve neurotomy. StudyStudy CharacteristicsMethodological Quality Score(s)Number of PatientsPain Relief (months)Results6 mos.12 mos.Short-term reliefLong-term relief d" 6 mos. > 6 mos. Cervical Lord et al 199648RA, DB 67 24-control 24-active 1 of sham 7 of active 58% in active treatment group P P Sapir and Gorup 200149O 87 46 NA Mean VAS change 4.6 1.8 P P McDonald et al 199950O 65 28 NA 71% P P Barnsley 200551O 54 35 NA 74% P P Lumbar Nath et al 200852RA, DB 50 20-control 20-active SI NA P NA Gofeld et al 200753O 63 174 68% NA P P Dreyfuss et al 200054O 73 15 87% 87% P P RA = randomized; DB = double blind; O = Observational; NA = not available; SI = significant improvement; VAS = visual analog scale; P = positive; N = negative Source: Falco FJE et al. Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions. Pain Physician 2009; 12:323-344.7 Datta S et al. Systematic assessment of diagnostic accuracy and therapeutic utility of lumbar facet joint interventions. Pain Physician 2009; 12:437-460.8 The recommendation yielded 1C/strong evidence based on Guyatt et als criteria.47 1.4 Indications and Medical Necessity Medical necessity must be established for each and every procedure and encounter. General documentation requirements for spinal interventional techniques for indications and medical necessity are as follows: 1. Complete initial evaluation including history and physical examination. 2. Physiological and functional assessment, as necessary and feasible. 3. Definition of indications and medical necessity, as follows: ( Suspected organic problem. ( Non-responsiveness to conservative modalities of treatment. ( Pain and disability of moderate-to-severe degree. ( No evidence of contraindications such as severe spinal stenosis resulting in intraspinal obstruction, infection, or predominantly psychogenic pain. ( Responsiveness to prior interventions with improvement in physical and functional status for repeat blocks or other interventions. ( Repeating interventions only upon return of pain and deterioration in functional status. ( Common indications for diagnostic facet joint interventions are as follows: ( Somatic or nonradicular neck, mid back, upper back or low back and headache, upper extremity pain, chest wall pain or lower extremity pain. ( Duration of pain of at least 3 months. ( Average pain levels of e" 6 on a scale of 0 to 10. ( Intermittent or continuous pain causing functional disability. ( Failure to respond to more conservative management, including physical therapy modalities with exercises, chiropractic management, and nonsteroidal anti-inflammatory agents. ( Lack of evidence, either for discogenic or sacroiliac joint pain. ( Lack of disc herniation or evidence of radiculitis. ( No contraindications with understanding of consent, nature of the procedure, needle placement, or sedation. ( No history of allergy to contrast administration, local anesthetics, steroids, Sarapin, or other drugs potentially utilized. ( Contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate nonsteroidal anti-inflammatory drugs. ( Common indications for therapeutic facet joint interventions are based on the above indications and positive response to controlled local anesthetic blocks (<1 mL per nerve) with a criterion standard of 80% pain relief with ability to perform prior painful movements without any significant pain. Frequency of Interventions: ( In the diagnostic phase, a patient may receive 2 procedures at intervals of no sooner than one week or preferably 2 weeks, with careful judgment of response. ( In the therapeutic phase (after the diagnostic phase is completed), the suggested frequency would be 2-3 months or longer between injections, provided that e" 50% relief is obtained for 8 weeks. ( If the interventional procedures are applied for different regions, they may be performed at intervals of no sooner than one week or preferably 2 weeks for most types of procedures. ( It is suggested that therapeutic frequency remain at least a minimum of 2 months for each region, it is further suggested that all the regions be treated at the same time provided that all procedures can be performed safely. ( In the treatment or therapeutic phase, the interventional procedures should be repeated only as necessary according to the medical necessity criteria, and it is suggested that these be limited to a maximum of 4 times for local anesthetic and steroid blocks over a period of one year, per region. ( Under unusual circumstances with a recurrent injury or cervicogenic headache, procedures may be repeated at intervals of 6 weeks after stabilization in the treatment phase. ( For medial branch neurotomy, the suggested frequency would be 6 months or longer (maximum of 2 times per year) between each procedure, provided that 50% or greater relief is obtained for 10 to 12 weeks. ( The therapeutic frequency for medial branch neurotomy should remain at intervals of at least 6 months per each region with multiple regions involved. It is further suggested that all regions be treated at the same time, provided all procedures are performed safely. ( Cervical and thoracic are considered as one region and lumbar and sacral are considered as one region for billing purposes. Change of language will not only reduce waste, fraud and abuse, but also improve the access and provide quality care. 2. TRIGGER POINT INJECTIONS No comment 3. SACROILIAC JOINT INJECTIONS There is no significant evidence with regards to the therapeutic effectiveness of sacroiliac joint interventions as rightly showed in your evaluation and all other guidelines and systematic reviews. Rupert et al55 in a systematic review provided the latest evidence with prevalence of sacroiliac joint pain to range between 10% and 38% with a false-positive rate of 20% to 54%. The evidence was Level II-3 or limited for therapeutic interventions with a weak recommendation. Thus, these procedures may be approved with the same frequency limiting to a maximum of 4 therapeutic procedures per region lumbar, with appropriate documentation if they meet indications and medical necessity as described above and the following indications utilizing appropriate frequency of interventions. ( Common indications are as follows: ( Somatic or nonradicular low back and lower extremity pain below the level of L5 vertebra. ( Duration of pain of at least 3 months. ( Average pain levels of e" 6 on a scale of 0 to 10 ( Intermittent or continuous pain causing functional disability. ( Failure to respond to more conservative management, including physical therapy modalities with exercises, chiropractic management, and non-steroidal anti-inflammatory agents. ( Lack of obvious evidence for disc-related or facet joint pain. ( No contraindications with understanding of consent, nature of the procedure, needle placement, or sedation. ( No history of allergy to contrast administration, local anesthetics, steroids, Sarapin, or other drugs potentially utilized. ( Contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate nonsteroidal anti-inflammatory drugs. ( For therapeutic sacroiliac joint interventions with intraarticular injections or radiofrequency neurotomy, the joint should have been positive utilizing controlled diagnostic blocks. Recommendation for frequency of interventions are as follows: ( In the diagnostic phase, a patient may receive 2 procedures at intervals of no sooner than one week or preferably 2 weeks. ( In the therapeutic phase (after the diagnostic phase is completed), the suggested frequency would be 2 months or longer between injections, provided that > 50% relief is obtained for 6 weeks. ( If the procedures are done for different joints, they should be performed at intervals of no sooner than one week or preferably 2 weeks. It is suggested that therapeutic frequency remain at 2 months for each joint. It is further suggested that both joints be treated at the same time, provided the injections can be performed safely. ( In the treatment or therapeutic phase, the interventional procedures should be repeated only as necessary according to the medical necessity criteria, and it is suggested that they be limited to a maximum of 4 times for local anesthetic and steroid blocks over a period of one year, per region. ( Under unusual circumstances with a recurrent injury, procedures may be repeated at intervals of 6 weeks after stabilization in the treatment phase. ( For sacroiliac joint radiofrequency neurotomy, the suggested frequency is 3 months or longer between each procedure (maximum of 3 times per year), provided that >50% relief is obtained for 10 to 12 weeks. 4. EPIDURAL INJECTIONS The document states that epidural injections are approved only as part of a comprehensive management program which included physical therapy, patient education, psychosocial support, and oral medications, where appropriate, will become very expensive. Essentially epidural injections must be performed under fluoroscopy only. Further indications should be defined separately as the evidence is variable for disc herniation and radiculitis, discogenic pain, post-laminectomy syndrome, spinal stenosis, and technique-caudal, interlaminar, transforaminal, and per region cervical and thoracic, lumbar and sacral. The review utilized by Armon et al56 from American Academy of Assessment is considered highly flawed. Even Chou et al25 considered this evidence as low quality. In contrast, ASIPP guidelines and multiple systematic reviews9,57-60 of caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections showed variable evidence based on each condition.61-65 4.1 Caudal Epidural Injections Conn et al57 in a systematic review evaluating the effect of caudal epidural injections with or without steroids in managing various types of chronic low back and lower extremity pain emanating as a result of disc herniation or radiculitis, post-lumbar surgery syndrome, spinal stenosis, and chronic discogenic pain without disc herniation or radiculitis has shown Level I evidence for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis and discogenic pain without disc herniation or radiculitis. Further, this systematic review also provided an indicated level of evidence of II-1 or II-2 for caudal epidural injections in managing chronic pain of post-lumbar surgery syndrome and spinal stenosis. The results of this systematic review were provided utilizing contemporary systematic review methodology utilizing randomized trials and observational studies, even though most of the evidence was derived from randomized trials. Table 6 illustrates the studies utilized in managing lumbar disc herniation or radiculitis with caudal epidural injection.66-71 More recently another manuscript was published in Spine72 which was not included in this analysis. The only study included in Conn et als57 analysis by Manchikanti et al66 was performed with fluoroscopic visualization. Table 6. Results of randomized trials of effectiveness of caudal epidural steroid injections in managing pain of lumbar disc herniation/radiculitis. Study Study Characteristics Methodological Quality Scoring Participants Pain Relief Results 3 mos. 6 mos. 12 mos. Short-term relief d" 6 mos. Long-term relief > 6 mos. Manchikanti et al 200866* RA, DB 72 84 81% 86% 79% to 81% P P Dashfield et al 200567* RA, DB 50 Caudal = 30 Endoscopy = 30SI SI NA P NA Bush and Hillier 199168 RA, DB 55 23 SI NSI NSI P N Mathews et al 198769 RA, DB 62 C = 34 T = 23SI SI SI N P Hesla and Breivik 197970 RA, DB 58 69 patients: crossover design 77% vs 29% 59% vs 25% 59% vs 25% P P Breivik et al 197671 RA, DB 68 C = 19 T = 1620% vs 50% 20% vs 50% NA P NA *Indicates use of fluoroscopy RA = randomized; DB = double blind; C = control; T = treatment; NA = not available; SI = significant improvement; NSI = no significant improvement; vs = versus; P = positive; N = negative Adapted and modified from Conn A et al. Systematic review of caudal epidural injections in the management of chronic low back pain. Pain Physician 2009; 12:109-135.57 Conn et al57 showed the evidence as illustrated in Table 7. Only one study was performed under fluoroscopy.73 Table 8 shows the evidence in managing spinal stenosis again with only study being performed under fluoroscopy.74 Table 9 illustrates results of studies of effectiveness of caudal epidural injections in managing discogenic pain. Table 7. Results of randomized trials in managing low back pain of post-surgery syndrome with caudal epidural injections. Study Study Characteristics Methodological Quality Scoring Participants Pain Relief Results 3 mos. 6 mos. 12 mos. Short-term relief d" 6 mos.Long-term relief > 6 mos.Manchikanti et al 200873* RA, DB 70 40 65% to. 70% 60% 60% to 65% P P Revel et al 199675 RA 62 Forceful injection = 29 Regular = 31NA 49% vs 19% NA P P Hesla and Breivik 197970 RA, DB 58 69 patients: crossover design 77% vs 29% 59% vs 25% 59% vs 25% P P *Indicates use of fluoroscopy RA = randomized; DB = double blind; NA = not available; vs = versus; P = positive; N = negative Adapted and modified from Conn A et al. Systematic review of caudal epidural injections in the management of chronic low back pain. Pain Physician 2009; 12:109-135.57 Table 8. Results of effectiveness in evaluation in managing spinal stenosis. Study Study Characteristics Methodological Quality Scoring Participants Pain Relief Results 3 mos. 6 mos. 12 mos. Short-term relief d" 6 mos. Long-term relief > 6 mos. Manchikanti et al 200874* RA, DB 70 40 50% to 65% 60% to 65% 55% to 65% P P Ciocon et al 199476 O 57 30 SI SI NA P NA Botwin et al 200777* O 61 34 65% 62% 54% P P *Indicates use of fluoroscopy RA = randomized; DB = double blind; O = observational; NA = not available; SI = significant improvement; vs = versus; P = positive; N = negative Adapted and modified from Conn A et al. Systematic review of caudal epidural injections in the management of chronic low back pain. Pain Physician 2009; 12:109-135.57 Table 9. Results of randomized and observational studies of effectiveness of caudal epidural steroid injections in managing discogenic pain. Study Study Characteristics Methodological Quality Scoring Participants Pain Relief Results 3 mos. 6 mos. 12 mos. Short-term relief d" 6 mos. Long-term relief > 6 mos.Manchikanti et al 200878 RA, DB 72 64 78% 75% to 81% 72% P P Manchikanti et al 200179* O 76 70 95% 85% 61% to 73% P P Manchikanti et al 200280* O 73 62 86% 60% NA P NA *Indicates use of fluoroscopy RA = randomized; DB = double blind; O = observational; NA = not available; P = positive; N = negative Adapted and modified from Conn A et al. Systematic review of caudal epidural injections in the management of chronic low back pain. Pain Physician 2009; 12:109-135.57 4.2 Interlaminar Epidural Injections As shown repeatedly multiple systematic reviews provided negative opinions for lumbar interlaminar epidural injections. However, recently 2 systematic reviews were performed evaluating lumbar and cervical interlaminar epidurals.58,59 They arrived at conflicting conclusions with systematic review of the effectiveness of the cervical epidurals in the management of chronic neck pain illustrating Level II-1 evidence in managing chronic neck and upper extremity pain,59 whereas, the evidence if Level II-2 for short-term relief of pain of disc herniation or radiculitis utilizing blind interlaminar epidural steroid injections with lack of evidence for long-term relief. However, all lumbar interlaminar and cervical interlaminar studies were performed without fluoroscopy. There are studies being conducted with fluoroscopy which may change the results. Presently the evidence for blind lumbar interlaminar epidurals disc herniation and radiculitis with lumbar interlaminar is negative.58 Thus, these should be mandated to be performed under fluoroscopy and we believe that the results will be similar to caudal and transforaminal when performed appropriately. The evidence was also negative for chronic low back pain of discogenic origin without radiculitis or disc herniation and no evidence is available in spinal stenosis. We do not recommend lumbar interlaminar epidural injections in post-surgery syndrome unless the needle placement and epidural entry can be performed below the level of the scar to avoid complications. The recent systematic review of cervical epidural injections59 also utilized blind cervical epidural studies with significant evidence as shown in Table 10. However, none of the studies were performed under fluoroscopy and such studies are awaiting publication. Table 10. Results of published studies of effectiveness of cervical interlaminar epidural steroid injections. Study Study Characteristics Methodological Quality Scoring Participants Pain Relief Results 3 mos. 6 mos. 12 mos. Short-term relief d" 6 months Long-term relief > 6 months Castagnera et al 199481 RA 55 Local anesthetic with steroids =14 Local anesthetic with steroids and morphine =1079% 79% 79% P P Stav et al 199382 RA 50 C = 17 T = 2512% vs 68% 12% vs 68% 12% vs 68% P P Pasqualucci et al 200783 RA 56 Single = 20 Continuous = 20 Over 180 daysNA 58% vs 74% NA P NA RA = randomized; C = control; T = treatment; vs = versus; P = positive; N = negative; NA = not available Adapted from Benyamin RM et al. Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain. Pain Physician 2009; 12:137-157.59 4.3 Lumbar Transforaminal Epidural Injections The systematic review by Buenaventura et al60 indicated the evidence is Level II-1 for short-term relief and Level II-2 for long-term relief in managing chronic low back and lower extremity pain. Table 11 illustrates randomized trials of effectiveness of lumbar transforaminal epidural injections. Table 11. Results of randomized trials of effectiveness of lumbar transforaminal epidural injections. Study Study Characteristics Methodological Quality Scoring Participants Pain Relief Results 3 mos. 6 mos. 12 mos. Short-term relief d" 6 mos. Long-term relief > 6 mos. Karppinen et al 2001/200184,85 RA, DB 81 C = 80 T = 80 SICH NSI NSI P N Riew et al 2000/ 200686,87 P, RA, DB 68 55 NA NA 33% vs. 71% (avoided surgery)P P Jeong et al 200788 RA, DB 63 239 PG 99 of 112 G 90 of 127PG 64 of 106 G 78 of 116NA P NA Vad et al 200289 RA 58 48 NA NA 48% vs. 84% P P RA = randomized; DB = double blind; P = prospective; C = control; T = treatment; PG = pre-ganglionic; G = ganglionic; SICH = significant improvement in contained disc herniation; NSI = no significant improvement; vs. = versus; NA = not available; P = positive; N = negative. Adapted from Buenaventura RM et al. Systematic review of therapeutic lumbar transforaminal epidural steroid injections. Pain Physician 2009; 12:233-251.60 4.4 Indications and Medical Necessity All in all, epidural injections must be recommended with 2 treatments in the diagnostic phase and 4 therapeutic interventions per region per year after the diagnostic phase is completed they meet indications and medical necessity and it is well documented. ( Common indications for caudal epidural injections are as follows: ( Chronic low back and/or lower extremity pain which has failed to respond or poorly responded to noninterventional and nonsurgical conservative management resulting from: ( Disc herniation/lumbar radiculitis ( Lumbar spinal stenosis ( Post lumbar surgery syndrome ( Epidural fibrosis ( Degenerative disc disease/discogenic low back pain ( Other causes ( Absence of facet joint pain determined by controlled local anesthetic blocks. ( Intermittent or continuous pain causing functional disability. ( Average pain level of e" 6 on a scale of 0 to 10. ( Indications for lumbar interlaminar are same as for caudal epidural injections, except for post-surgery syndrome. ( Caudal epidural is the modality of choice for post-surgery syndrome. ( Common indications for cervical interlaminar are as follows:| ( Chronic neck and/or upper extremity pain which has failed to respond or poorly responded to non-interventional and non-surgical conservative management resulting from: ( Herniated, protruded, or extruded disc with or without radiculitis ( Cervical spinal stenosis ( Post cervical surgery syndrome ( Degenerative disc disease ( Other causes ( Absence of facet joint pain determined by controlled local anesthetic blocks. ( Intermittent or continuous pain causing functional disability. ( Average pain level of e" 6 on a scale of 0 to 10. ( Common indications for thoracic interlaminar are as follows: ( Chronic mid back or upper back pain which has failed to respond or poorly responded to non-interventional and non-surgical conservative management resulting from: ( Herniated, protruded, or extruded disc with or without radiculitis ( Thoracic spinal stenosis ( Thoracic post-surgery syndrome ( Degenerative disc disease ( Other causes ( Common indications for lumbar transforaminal epidurals are provided for diagnostic and therapeutic purposes. Diagnostic indications: ( To identify an inflamed nerve root in a patient with a history of radicular pain when results of visual anatomic studies and neurophysiologic studies are not collaborative. ( To identify the pain generator when patients have multiple abnormalities on visual anatomic studies. ( To determine the symptomatic level in multilevel disc herniation. ( To determine a primary pain generator in the spine-hip syndrome. ( To determine a previously undocumented nerve root irritation as a result of spondylolisthesis. ( To determine the symptomatic level in multilevel stenosis. ( To determine the symptomatic root in patients with documented postoperative fibrosis. Therapeutic indications: ( Average pain levels of e" 6 on a scale of 0 to 10 ( Intermittent or continuous pain causing functional disability ( Chronic low back and/or lower extremity pain which has failed to respond or poorly responded to non-interventional and non-surgical conservative management ( Chronic low back and/or lower extremity pain resulting from: ( Disc herniation ( FBSS without extensive scar tissue and hardware ( Spinal stenosis with radiculitis ( Discogenic pain with radiculitis 4.4.1 Frequency of Interventions ( Guidelines of frequency of interventions apply to epidural injections caudal, interlaminar, and transforaminal. ( In the diagnostic phase, a patient may receive 2 procedures at intervals of no sooner than one week or preferably 2 weeks except in cancer-related pain or when a continuous administration of local anesthetic is employed for CRPS. ( In the therapeutic phase (after the diagnostic phase is completed), the suggested frequency of interventional techniques should be 2 months or longer between each injection, provided that >50% relief is obtained for 8 weeks. ( If the neural blockade is applied for different regions, they may be performed at intervals of no sooner than one week and preferably 2 weeks for most types of procedures. The therapeutic frequency may remain at intervals of at least 2 months for each region. It is further suggested that all regions be treated at the same time, provided all procedures can be performed safely. ( In the treatment or therapeutic phase, the epidural injections should be repeated only as necessary according to medical necessity criteria, and it is suggested that these be limited to a maximum of 4 times per year. ( Under unusual circumstances with a recurrent injury, cancer-related pain, or CRPS, blocks may be repeated at intervals of 6 weeks or less after diagnosis/stabilization in the treatment phase. ( Cervical and thoracic regions are considered as one region and lumbar and sacral are considered as one region. 5. CHYMOPAPAIN CHEMONUCLEOLYSIS This technique is not available in the United States. 6. PERCUTANEOUS LUMBAR DISCECTOMY No comment. 7. NONPULSED RADIOFREQUENCY FACET DENERVATION This has been described above under facet joint interventions along with indications. 8. IMPLANTABLE INFUSION PUMPS No comment. 9. PEDICLE SCREWS No comment. 10. INTERVERTEBRAL BODY FUSION DEVICES No comment. 11. PERCUTANEOUS POLYMETHYLMETHACRYLATE VERTEBROPLASTY It appears to be significant confusion with regards to vertebroplasty. The document section XI on page 5 of 65 shows it as an approved procedure with multiple indications. Further, on pages 11 to 13 also provides an impression that this is a covered procedure. However, policy and practice updates bulletin states that effective 03/01/2010 vertebroplasty, kyphoplasty, and vesselplasty (e.g., Vessel-X) will be considered experimental and investigational as noted in Clinical Policy Bulletin #0016. These are contradictory statements. We are confident that this is just a oversight and a mistake. Even NICE has approved this treatment for clinical use. II. EXPERIMENTAL AND INVESTIGATIONAL INTERVENTIONS We will comment only on the relevant procedures. Number IV and IX percutaneous adhesiolysis. This document utilized older studies and also misinterpreted and misguided evaluations. ASIPP guidelines9 and systematic review performed by Epter et al90 utilizing 7 studies,91-97 3 of which were randomized,91-93 concluded that the indicated level of evidence is I or II-1 for short- and long-term relief of percutaneous adhesiolysis in post-lumbar surgery syndrome. At the time of this systematic review no evidence was available for spinal stenosis. Table 12 shows the evidence synthesis for post-laminectomy syndrome. In addition to this, stronger evidence is available now with 2 randomized trials evaluating either post-surgery syndrome or spinal stenosis.98,99 In the study of post-lumbar surgery syndrome, Manchikanti et al98 in a randomized double-blind trial evaluated 60 patients in each group showing significant improvement of pain ((50%) and function ((40%) with Oswestry in 73% of patients compared to 12% in the caudal epidural group with catheter positioned at S3. Table 12. Results of published studies effectiveness of percutaneous lysis of lumbar epidural adhesions. Study Study Characteristics Participants Pain Relief Results d" 3 mos. 3 mos. 6 mos. 12 mos. Short-term d" 6 mos. Long-term >6 mos. Manchikanti et al 200491 RA, DB G1 = 25 G2 = 25 G3 = 25 G1 = 33% G2 = 64% G2 = 72% G1 = 0% G2 = 64% G3 = 72% G1 = 0% G2 = 60% G3 = 72% G1 = 0% G2 = 60% G3 = 72% P P Heavner et al 199992RA, DB 59 83% 49% 43% 49% P P Veihelmann et al 200693RA 99 SI SI SI SI P P Manchikanti et al 200194O G1 = 15 G2 = 3097% 93% 47% P P Manchikanti et al 199995O 60 100% 90% 72% 52% P P Manchikanti et al 199996O 129 79% 68% 36% 13% P N Gerdesmeyer et al 200597O 61 SI SI SI SI P P  RA = randomized; DB = double blind; O = observational; G = group; SI = significant improvement; P = positive; N = negative Adapted from Epter RS et al. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician 2009; 12:361-378.90 This solidifies the results of previous studies and provides better evidence. Thus, Aetna should cover this procedure definitely for post-surgery syndrome. Spinal stenosis also has been studied in a randomized, double-blind, controlled trial.92 The preliminary results of 25 patients in each group showed significant pain relief (> 50%) in 76% of the patients at one year follow-up in the adhesiolysis group compared to 4% of the patients in the control group. They concluded with significant pain relief in 76% of patients, percutaneous adhesiolysis utilizing local anesthetic, steroids, and hypertonic sodium chloride solution may be effective in patients with chronic function-limiting low back and lower extremity pain with spinal stenosis. Thus percutaneous adhesiolysis on a one-day protocol may be approved when the patients meet appropriate indications and medical necessity are documented. Further, the indications for percutaneous adhesiolysis are as follows: ( Common indications are as follows: ( Chronic low back and/or lower extremity pain resulting from: ( Failed back surgery syndrome/epidural fibrosis ( Spinal stenosis ( Disc herniation with radiculitis ( Duration of pain of at least 6 months. ( Intermittent or continuous pain causing functional disability. ( Average pain levels of e" 6 on a scale of 0 to 10. ( Failure to respond or poor response to noninterventional and non-surgical conservative management and fluoroscopically-directed epidural injections ( Absence of facet joint pain determined by controlled local anesthetic blocks Recommend frequency for percutaneous adhesiolysis is as follows: ( The number of procedures are preferably limited to: ( 4 interventions per year, with a one-day protocol. 1. PERCUTANEOUS DISC DECOMPRESSION Laser disc decompression has been described under experimental category for non-coverage, however, in patients who are selected appropriately automated percutaneous lumbar discectomy (APLD) and percutaneous lumbar laser discectomy (PLLD) will be appropriate and deserve coverage. Even though Cochrane review by Gibson and Waddell100 stated that any form of discectomy other than traditional open discectomy is unresolved, considering the cost effectiveness APLD and APLLD will be appropriate and highly cost effective. 1.1 Automated Percutaneous Lumbar Discectomy (APLD) The systematic review by Hirsch et al101 and ASIPP guidelines9 utilizing a combination of randomized trials and observational studies with only one randomized trial meeting inclusion criteria for evidence synthesis102 and with 10 observational studies meeting inclusion criteria for evidence synthesis concluded that the indicated level of evidence is Level II-2 in properly selected patients with contained lumbar disc prolapse. The recommendation is 1C/strong recommendation however, patients must be selected appropriately with indications as follows and documentation of medical necessity as described earlier. ( Indications of percutaneous mechanical disc decompression include the following: ( Unilateral leg pain greater than back pain. ( Radicular symptoms in a specific dermatomal distribution that correlates with MRI findings. ( Positive straight leg raising test or positive bowstring sign, or both. ( Neurologic findings or radicular symptoms. ( No improvement after 6 weeks of conservative therapy. ( Imaging studies (CT, MRI, discography) indicating a subligamentous contained disc herniation. ( Well maintained disc height of 60%. 1.2 PERCUTANEOUS LUMBAR LASER DISCECTOMY (PLLD) Singh et al103 in a systematic review of current evidence which included only observational studies, indicated the level of evidence for PLLD as Level II-2 for short- and long-term relief with a 1C/strong recommendation for PLLD. The evidence for nucleoplasty and mechanical high RPM device or Dekompressor is limited. Indications for APLLD are the same as APLD. At this time, we request Aetna to consider this basically non-invasive and inexpensive modality which is covered by Medicare and other insurers. If Aetna considers laser discectomy as not effective at all they should at least cover APLD and accumulate the results for future coverage until randomized or comparative effectiveness trials appear. 2. SPINAL CORD STIMULATION Spinal cord stimulation has not been described. The systematic review by Frey et al104 and ASIPP guidelines9 indicated the evidence to be Level II-1 or II-2 for clinical use on a long-term basis in relieving chronic intractable pain of failed back surgery syndrome. Cost effectiveness also has been published. Further, NICE and other organizations have shown that there is significant evidence for spinal cord stimulation in neuropathic pain. Frey et al104 provided Level II-1 or II-2 for long-term relief in managing patients with failed back surgery syndrome with 1B or 1C/strong recommendation for clinical use on a long-term basis. Indications and medical necessity must be appropriately documented and proper trial is documented. III. CODING SECTION 1. Facet joint injection codes are old codes, these have to be updated as follows: 64490, 64491, 64492 for cervical and thoracic and 64493, 64494, 64495 for lumbar. The new 6 codes are inclusive of fluoroscopy whereas, radiofrequency codes seem to not include fluoroscopy at the present time in their pricing (77003). ICD-9 codes for facet joint interventions do not include facet joint pain in multiple regions: 721.0, 721.2, and 721.3. Facet joint interventions are not indicated for sciatica. For sacroiliac joint injections 720.2 (Sacroiliitis, not elsewhere classified, Inflammation of sacroiliac joint NOS) is the most commonly utilized sacroiliac joint arthropathy code and is not listed under ICD-9 codes. Sacroiliac joint injections must not be performed for pain in the thoracic spine or plain lumbago, or sciatica. 2. The CPT codes for epidural injections should also include transforaminal epidural codes 64483 and 64484. For epidural injections ICD-9 codes should include disc herniation, radiculitis, sciatica, and degenerative disc disease as follows: 722.10 for lumbar disc herniation and 724.4 for radiculitis Other diagnostic codes include post laminectomy syndrome and spinal stenosis 722.81, 722.82, 722.83, and for spinal stenosis 723.0, 724.01, and 724.02. Epidural injections may be also indicated for disc displacement with myelograph 722.71, 722.72, and 722.73. Other indicated codes are cervical disc herniation and thoracic disc herniation 722.0 and 722.11 along with cervical or thoracic radiculitis 723.4 and 724.4. The indications listed as cervicalgia, lumbago, backache, etc. are inappropriate for epidural injections. Only the sciatica is appropriate indication. 3. Radiofrequency neurotomy for facet joint pain, codes should include 721.0, 721.2, and 721.3. There is no role for radiofrequency neurotomy in sciatica. Further, once a diagnosis of facet joint pain is made, there is no necessity to use non-specific diagnosis as pain the spine, cervicalgia, cervicocranial syndrome, etc. 4. CPT and ICD-9 codes for percutaneous adhesiolysis are CPT 62264 and 62263. ICD-9 diagnostic codes are 722.83 and 724.02. 5. Spinal cord stimulation codes may be added for lead placement along with diagnostic codes with indications. Thank you for your consideration. If you have any questions please feel free to contact us. Laxmaiah Manchikanti, MD Chief Executive Officer and Chairman of the Board, ASIPP and SIPMS Ramsin Benyamin, MD President, ASIPP Joshua Hirsch, MD Board of Directors, ASIPP Vijay Singh, MD Executive Committee Chairman, Lifetime Director, ASIPP Allan Parr, MD President-Elect, ASIPP Standiford Helm, MD Executive Vice President, ASIPP Frank Falco, MD Vice President Financial Affairs, ASIPP David Caraway, MD Vice President Strategic Planning, ASIPP LM/den 1. The National Uniform Claims Committee. Specialty Designation for Interventional Pain Management- 09. 2. Medicare Payment Advisory Commission. 2001. Report to the Congress: Paying for interventional pain services in ambulatory settings. Washington, DC: MedPAC. December. 3. Department of Health and Human Services. Office of Inspector General (OIG). Medicare Payments for Facet Joint Injection Services (OEI-05-07-00200). September 2008. 4. Manchikanti L, Singh V, Pampati V, Smith HS, Hirsch JA. 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