American Society ofInterventional Pain Physicians®
"The Voice of Interventional Pain Management"
81 Lakeview Drive, Paducah, KY42001
Phone: (270) 554-9412 - Fax: (270) 554-5394
November 23, 2016
Health Evidence Review Commission
.
RE:Coverage Guidance: Low Back Pain – Corticosteroid Injections
On behalf of the American Society of Interventional Pain Physicians (ASIPP), Oregon Society of Interventional Pain Physicians, and the other 50 state interventional pain physician societies, including Puerto Rico, we would like to submit our strong opposition to coverage guidance for low back pain, and request that thisguidance be withdrawn from consideration immediately to avoid drastic implications regardingaccess to effective interventional therapies.
The guidance seems to be developed from the Agency for Healthcare Research and Quality (AHRQ) evidence assessment by Chou et al[1]. AHRQ is an organization facing extinction once again.AHRQ was createdwhenthe Agency for Health Care Policy and Research (AHCPR) in was abolished in 1999, just 10 years after itsinception. The same authors, Chou et al1, have published multiple systematic reviews in various journals with funding fromAHRQ.This is not only a blatant conflict and confluence of interest, but their reviews have been proven to have flawed design, poor methodologic assessment, and clinically irrelevant outcomes in determining the therapeutic role of epidural and other injections for low back pain and radiculopathy. These findings are in contrast to the findings ofmultiple well performed systematic reviews.[2],[3],[4],[5], The AHRQ document which formed the basis for multiple systematic reviews by Chou et al, which was preceded by multiple other manuscripts, have shown various flaws in design, inappropriate methodologic quality assessment, and inaccurate conclusions.2-[6]
The major flaw in the synthesis by Chou and colleagues is related to conversion of active-controlled trials into placebo-controlled trials, coupled with the biased assessment of methodologic quality and subsequent results. Chou et al didnot follow the appropriate principles established by the Institute of Medicine (IOM) for evidence synthesis.They also showed significant intellectual bias with their poorly designed research andmeta-analysis. Numerous other systematic reviews that employedexcellent methodologic quality assessment, utilizing appropriate active-control design, have shownpositive results, not only for epidural injections, but also for multiple other injection therapiesin managing spinal pain.2-5,[7],[8],[9],[10] These systematic reviews overwhelmingly have demonstrated, based on high quality, randomized, controlled trials, that a local anesthetic and/or local anesthetic with steroids areeffective, whereas sodium chloride solution or steroid alone areineffective. The only studies showing inferior results were published by the same authors as in Chou et al’s reviews.Those studies utilizedpoor methodologic quality and a short-term follow-up, which is not considered a pragmatic study.[11],[12]Similar results have been shown in managing axial low back pain, lumbar post surgery syndrome, as well as good results for epidural injections in the thoracic and cervical spines. Further, multiple systematic reviews of facet joint injections and sacroiliac joint injections have yielded similar results with diagnostic validity and long-term effectiveness of facet joint and sacroiliac joint injections with or without steroids.
These irrational assessments and decisions, specifically in Oregon, may spread to the entire country based on a flawed metaanalysis and intellectual bias.Such a mistake will result in draconian decisions to eliminate coverage of important modalities and force patients to succumb to unnecessary, expensive therapeutic options, including opioids, other drug therapies, and surgical interventions. In fact, the commission should be aware of the 2 studies funded by the National Health Services (NHS) showing the effectiveness of epidural injections and also the coverage policies of NHS for epidural, facet joint, and sacroiliac joint interventions.[13],[14]
Among various efforts by multiple organizations, ASIPP has started a national registry to meet the criteria of the Merit-based Incentive Payment System (MIPS) and include nationwide outcomes for injection therapies.Thisshould provide the appropriate basis for utilization of these techniques beyond randomized controlled trials and systematic reviews.
Consequently, we recommend that the agency withdraw the present recommendation and engage in a proper analysis of the literature,free fromintellectual bias or conflict and confluence of interest.Thismay avoid major issues for patients and the extinction of AHRQ.
If you have any further questions, please feel free to contact us.
Thank you,
Laxmaiah Manchikanti, MD
Chairman of the Board and Chief Executive Officer, ASIPP
Medical Director, PainManagementCenter of Paducah
Clinical Professor
Anesthesiology and Perioperative Medicine
University of Louisville, Kentucky
67 Lakeview Dr.
Paducah, KY42001
Phone: 270-554-8373 ext. 101
Fax: 270-554-8987
E-mail:
LM/tmh
To view some of Dr. Manchikanti's publications go to:
“Never forget who was there for you when no one else was.” Unknown
“There is no limit to what a man can do or where he can go if he doesn’t mind who gets the credit.” Ronald Reagan
1
[1]Chou R, et al. Agency for Healthcare Research and Quality; July 10, 2015.
[2]Manchikanti L, et al. Pain Physician 2016; 19:E365-E410.
[3]Manchikanti L, et al. Clin Orthop Relat Res 2015; 473:1940-1956.
[4]Manchikanti L, et al. Surg Neurol Int 2015; 6:S194-S235.
[5]Kaye AD, et al. Efficacy of epidural injections in managing chronic spinal pain: A best evidence synthesis. Pain Physician 2015; 18:E939-E1004
[6] Boswell MV, Manchikanti L. Ann Intern Med 2015; 163:373-381. Evid Based Med 2016; 21:89.
[7]Manchikanti L, et al. Pain Physician 2015; 18:E535-E582.
[8]Manchikanti L, et al. World J Orthop 2016; 7:315-337.
[9]Manchikanti L, et al. Postgrad Med 2016; 128:54-68.
[10]Simopoulos TT, et al. Pain Physician 2015; 18:E713-E756.
[11]Friedly JL, et al. N Engl J Med 2014; 371:11-21.
[12] Manchikanti L, et al. Pain Physician2014; 17:E475-E488.
[13]Lewis RA, et al. Health Technol Assess2011; 15:1-578.
[14]Lewis RA, et al. Spine J2015; 15:1461-1477.