Re: Pain Mgmt Doctors Threaten ACOEM w/Class Action
Posted by Deborah on 1/29/11
Now this might get their attention and some elected officials too. On 1/28/11, Sharon Kramer wrote: > Experts Predict Harm to Patients > > Timothy Deer, MD, president of the Center for Pain Relief > in Charleston, W.Va., and chair of the American Society of > Anesthesiologists pain committee, said that if adopted in > their current form, the ACOEM guidelines would adversely > affect patients. > > �We�ve gone to general quarters on this,� one society > official told Pain Medicine News. �We�re talking > litigation. We�re talking class action. We see this as > pandering to the insurance companies,� said the clinician, > who did not want to be identified. �The insurance companies > will buy these guidelines and then cut and paste [the text] > on their denials.� > > �We don�t want this to be the de facto standard of care > nationwide,� said B. Todd Sitzman, MD, MPH, president of > the American Academy of Pain Medicine (AAPM). > > ACOEM itself has come under recent scrutiny for its ties to > business. The 5,000-member group, once called the > Industrial Medical Association, was the subject of a > January 2007 article in The Wall Street Journal that > questioned the objectivity of an ACOEM report rejecting a > link between mold and serious worker illness. The authors > of the report, according to the newspaper, were researchers > who frequently receive money to testify for companies named > in mold suits�a fact not disclosed in the report or by > ACOEM. > > Similar accusations were raised in a recent article in the > International Journal of Occupational and Environmental > Health (2007;13:404-426), which labeled ACOEM �a > professional association in service to industry� and said > that corporate �money and influence permeate every aspect > of occupational and environmental medicine.� > > > > Proposed Guidelines for Workers� Comp Patients Roil Pain > Specialists > > The nation�s pain groups have taken aim at proposed > guidelines for the treatment of chronic pain that discount > the utility of several staple interventional and > noninterventional therapies, such as certain medications, > epidural injections and spinal cord stimulation. > > If approved, the guidelines, from the American College of > Occupational and Environmental Medicine (ACOEM), could > affect the willingness of health insurers to pay for the > procedures in question, experts said. In the rationale > sections of its recommendations, the document frequently > comments on the cost-effectiveness of a given therapy. > Although interventional pain medicine is a relatively new > field, the growth of these procedures has been strong. > Medicare spent roughly $2 billion in 2005 on interventional > remedies. > > Experts Predict Harm to Patients > > Timothy Deer, MD, president of the Center for Pain Relief > in Charleston, W.Va., and chair of the American Society of > Anesthesiologists pain committee, said that if adopted in > their current form, the ACOEM guidelines would adversely > affect patients. > > �Some need minimally invasive procedures who won�t be > allowed to get those procedures,� Dr. Deer said. �They will > get more back surgery�which is not supported by the data�or > they will be on lifelong medications, including high-dose > opioids. There will be more failed surgeries, an increased > potential for addiction, worse outcomes, at more expense� > to the health care system. > > �We�ve gone to general quarters on this,� one society > official told Pain Medicine News. �We�re talking > litigation. We�re talking class action. We see this as > pandering to the insurance companies,� said the clinician, > who did not want to be identified. �The insurance companies > will buy these guidelines and then cut and paste [the text] > on their denials.� > > �We don�t want this to be the de facto standard of care > nationwide,� said B. Todd Sitzman, MD, MPH, president of > the American Academy of Pain Medicine (AAPM). > > After ACOEM released its guidelines for the treatment of > low back pain in 2004, California legislators mandated that > doctors in the state use the group�s recommendations� > outraging many physicians in the process. �We do not want > to happen what occurred in California, where physicians� > treatment of workers� compensation patients is dictated by > legislation to follow ACOEM guidelines,� Dr. Sitzman said > in an interview. (A California appeals court judge in June > 2007 ruled that the guidelines could apply only to acute > low back pain [LBP].) > > Squeaky Wheels? > > The societies� aggressive lobbying efforts may have paid > off�at the very least, the push bought pain specialists a > hearing. After initially declaring the review process > closed, ACOEM agreed to extend its evidence review another > six weeks, until late January, according to pain group > officials who participated in a Dec. 5 conference call with > ACOEM. > > One pain society head who sat in on the call described > ACOEM�s tone as �more conciliatory than we anticipated. > They informed us that they would reply to every comment > individually.� ACOEM representatives also suggested that > they would incorporate �substantive� comments�presumably > those supported by evidence�into the final version of the > guidelines, although the precise meaning of this concession > was not clear. > > The 455-page document, a copy of which, > marked �confidential,� was obtained by Pain Medicine News, > reviews the quality of the evidence available for therapies > and diagnostic tests for various forms of chronic pain, > such as chronic regional pain syndrome (CRPS), fibromyalgia > and LBP. The panel�consisting mainly of physicians but > including no specialists in interventional pain�broke each > therapy into three categories: recommended, no > recommendation and not recommended. > > Recommended treatments for CRPS include acetaminophen, > nonsteroidal anti-inflammatory drugs and tricyclic > antidepressants, which are also endorsed for neuropathic > pain. > > Not making the cut, however, were a litany of > interventional techniques: epidural steroid injections for > chronic LBP lacking �significant radicular symptoms� or as > a �first or second line treatment in individuals with LBP > symptoms that predominate over leg pain,� steroids for > trigger or tender point injections, facet joint injections > with hyaluronic acid, pain pumps, guanethidine and > methylprednisolone for CRPS and others. The guidelines also > reject the use of spinal cord stimulators�despite the > recent publication in the journal Pain of a randomized > controlled trial of the technology in patients with failed > back surgery syndrome (2007;132:179-188). > > Time Pressures > > Andrea Trescot, MD, president of the American Society of > Interventional Pain Practitioners (ASIPP), said her group > had received a copy of the draft guidelines for comment but > were told that the document would become official within a > matter of days. �It was clear they were not looking for > actual input,� said Dr. Trescot, director of the pain > fellowship at the University of Florida College of Medicine > in Gainesville. �If you truly want our input, then give us > time to make a reasonable and measured response.� > > Another flaw in the process, Dr. Trescot said, is that the > guidelines panel did not include any interventionalists, > although two physicians, Gerald Aronoff, MD, and Steven D. > Feinberg, MD, MPH, who served as consultants to the panel > are AAPM members. Dr. Aronoff was president of the group in > the mid-1980s. > > Still, the presence of those two specialists did not > produce a document that satisfied their society colleagues. > > In a Nov. 16, 2007, letter to ACOEM President Robert K. > McLellan, MD, MPH, Dr. Sitzman observed that the > guidelines �are often adopted by Workers� Compensation > carriers nationwide as part of their utilization review > process to make coverage decisions. Failure to provide a > fair, balanced and consistent approach could potentially > jeopardize the care of injured workers nationwide and > compromise the ability of Pain Medicine physicians to care > for those workers with chronic pain.� In the letter, Dr. > Sitzman laid out his group�s �several concerns� about the > guidelines process and the recommendations themselves. > > �The document does not present a balanced view of pain > management strategies but is clearly weighted toward non- > interventional/non-opioid strategies,� the letter > reads. �Rather than stating in the introduction that there > may be roles for interventional techniques or medication > therapy, the authors state explicitly that such approaches > are to be avoided.� > > Dr. Sitzman also described the ACOEM panel�s definition of > pain��a symptom rather than a disease��as �dogmatic.� > Although perhaps true for some patients, he said, this > definition ignores patients, such as those with CRPS or > certain neuropathic pain conditions, whose pain has a > neurobiological basis. �Unfortunately,� the letter > adds, �this statement seems to set the tone for much of the > document.� > > Lack of RCT Does Not Equal Lack of Evidence > > Other objections, according to Dr. Sitzman�s letter, > include the rejection of �expert consensus opinion� as a > valid form of scientific evidence and an unrealistic view > of data�or lack thereof�from randomized controlled trials > (RCTs): �There is an underlying theme that the lack of RCTs > [for a given therapy] equates with no evidence of > therapeutic efficacy and hence is �not recommended.� > Absence of proof is not proof of absence.� > > Dr. Aronoff, who is medical director of the Carolina Pain > Institute in Charlotte, N.C., said he did not agree with > every provision of the ACOEM guidelines. But he defended > the process and the end product as appropriate and > unbiased. And although Dr. Aronoff said that he often urged > panelists to consider the subjectivity of pain�and the > paucity of gold-standard studies for certain interventions� > in its deliberations, he was convinced that the guidelines > were not arbitrary. > > �If the review from ACOEM shows, by citing numerous > studies, that the data is very critical of a specific > procedure, practitioners may have reason to rethink their > use of that procedure,� Dr. Aronoff said. > > In the end, Dr. Aronoff added, clinicians need to keep in > mind that the guidelines are not laws, merely practice > recommendations, and that they will have little or no > impact on pain specialists who treat few or no workers� > compensation patients. �A physician is able to not use the > guidelines,� he said, �although if they do that, they would > need to explain why.� > > The editor of the guidelines was Kurt T. Hegmann, MD, MPH, > a specialist in occupational medicine at the University of > Utah School of Medicine in Salt Lake City. Dr. Hegmann is > named as a researcher on the document, along with a dozen > other people. > > Dr. McLellan, of ACOEM, said his group had so far received > letters from four pain societies�ASIPP, AAPM, the > International Spine Intervention Society and the North > American Neuromodulation Society. �The editor has seen > these letters and has incorporated some of the suggestions > in the most recent version of the chapter, which is still > being finalized,� Dr. McLellan said in an interview. The > final version of the document may be ready by the beginning > of the new year, he said. > > ACOEM: �No Ax To Grind� > > In addition, said Dr. McLellan, an occupational medicine > specialist at Dartmouth-Hitchcock Medical Center in > Lebanon, N.H., ACOEM has tried to extend an olive branch to > the pain groups, asking for a face-to-face meeting to > discuss the guidelines. �Needless to say, when current > practice is questioned people get concerned. I�m not > shocked, but our goal here is to provide the best-quality > care. We don�t have another ax to grind.� > > The chronic pain guidelines are not the first time ACOEM > has angered pain specialists. The group�s recommendations > on LBP, published as a chapter in its 2004 guidelines, were > widely seen in the field as a significant blow. > > Some Say Group Is Overcozy With Industry > > ACOEM itself has come under recent scrutiny for its ties to > business. The 5,000-member group, once called the > Industrial Medical Association, was the subject of a > January 2007 article in The Wall Street Journal that > questioned the objectivity of an ACOEM report rejecting a > link between mold and serious worker illness. The authors > of the report, according to the newspaper, were researchers > who frequently receive money to testify for companies named > in mold suits�a fact not disclosed in the report or by > ACOEM. > > Similar accusations were raised in a recent article in the > International Journal of Occupational and Environmental > Health (2007;13:404-426), which labeled ACOEM �a > professional association in service to industry� and said > that corporate �money and influence permeate every aspect > of occupational and environmental medicine.� > > In a letter on ACOEM�s Web site, Dr. McLellan rejected > those accusations, calling them a �conspiracy theory� > that �inaccurately and unfairly characterize ACOEM�s > historical role and current activities in occupational and > environmental medicine and are based largely on unfounded > and irresponsible accusations.� > > ACOEM Defends Pain Guidelines > To The Editor: > > The American College of Occupational and Environmental > Medicine respectfully disagrees with comments in the recent > article �Draft Guidelines for Workers� Comp Care Roil Pain > Field,� (Pain Medicine News, January 2008, page 1) > suggesting that our Practice Guidelines for Chronic Pain > are biased against pain interventionalists. > > We believe that our process, which adheres to standards for > the development of guidelines established by the AGREE > Collaboration, the Institute of Medicine and the American > Medical Association, was fairly and consistently applied in > the compilation of our new chapter on chronic pain. The > Chronic Pain Panel was convened with representation from a > broad variety of specialties, including senior pain > specialists (two of whom are past presidents of the > American Academy of Pain Medicine), pain interventionalists > and a cross-section of pain-related societies. The opinions > and judgments of pain interventionalists serving on the > panel were heavily relied on during the development of the > Chronic Pain guidelines. > > External peer review by a diverse cross-section of > organizations and health practitioners is an essential > component of our guideline development process and it was > fully utilized in this case. It is also important to note > that the guidelines reviewed by Pain Medicine News and peer > organizations are in draft form, and have not been > published. ACOEM�s recommendations remain under discussion > and external comments are being considered as a part of the > standard external peer-review process. External peer-review > comments are considered and incorporated whenever > consistent with our published evidence-based methodology. > > Regarding the quality of our evidence, as a physician-led, > science-based organization with a focus on improving the > health and safety of our nation�s workers, our philosophy > has been to rely on only the highest-quality evidence in > support of optimal health outcomes for those in the > workplace. Appropriately, we take a fundamentally > conservative approach to care that is built on the primary > tenet of medicine��first, do no harm��and relies on a > widely and internationally accepted standard for what is > considered quality evidence. Our process for applying these > criteria is clearly articulated in our methodology > statements, which are publicly available, and it has been > accepted as reasonable and satisfactory by the many > organizations that have participated as peer reviewers of > our guidelines. We have taken every reasonable step to > ensure that the best evidence underlies our recommendations. > > Finally, ACOEM�s Practice Guidelines are not published in > order to rigidly mandate treatments and, in fact, the > guidelines fully acknowledge that in some cases alternative > treatments outside the recommended course of action may be > warranted. We are publicly on record with this position. > > Robert K. McLellan, MD, MPH, ACOEM president > > > > > > Pain Group Heads Respond > > Dear Editor: > > As presidents and past presidents of leading interventional > pain societies, we are writing to disagree with a recent > response by the American College of Occupational and > Environmental Medicine (ACOEM) to concerns we have raised > regarding ACOEM�s recently published revision to its Low > Back Chapter and soon-to-be published Chronic Pain Chapter. > > First, ACOEM�s process has excluded the very experts > qualified to evaluate a wide range of interventional pain > therapies. Despite ACOEM�s contention that its chronic pain > panel �was convened with representation from a broad > variety of specialties to cover the diverse needs of pain > patients,� the process included only two pain physicians > with uncertain expertise in interventional pain medicine. > > Significantly, it also omitted two leading pain > intervention societies in its external review�the American > Society of Interventional Pain Physicians (ASIPP) and the > International Spine Intervention Society (ISIS). Further, > only one of our organizations, the North American > Neuromodulation Society (NANS), was invited to formally > participate in the Low Back Chapter revision; none of NANS� > substantive recommendations was included in the final, > published version of that document. > > Given the extensive number of interventions evaluated by > ACOEM�including highly complex subspecialty areas such as > neuromodulation�it is difficult to understand how such > limited representation constitutes a sufficient external > review process. > > Second, ACOEM contends that its practice guidelines �are > not published in order to rigidly mandate treatments.� > However, the efforts by ACOEM to achieve official > recognition of its guidelines as a presumptive standard for > medical necessity and utilization review by state workers� > compensation programs are well known�promoting the > practical and legal effect of rigidly mandating treatments. > > Third, ACOEM contends that it takes �a fundamentally > conservative approach to care that is built upon the > primary tenet of medicine��first, do no harm.�� However, in > recommending against therapies such as oral opioids and > spinal cord neurostimulators (Low Back Chapter)�therapies > with a long and established role in treating certain forms > of chronic, intractable pain�ACOEM assumes that such > interventions do harm. We strongly challenge this judgment > because of the substantial evidence that they can alleviate > the often unbearable suffering of well-selected pain > patients. > > Finally, we question ACOEM�s fee-for-access approach to > guidelines, which stands in contrast to leading medical > societies that routinely disseminate clinical guidelines > online, without charge, on topics within their clinical > expertise. > > Unfortunately, substantial disagreements remain over the > process used to create the ACOEM Low Back and Chronic Pain > Guidelines. We certainly invite a continuation of this > dialogue; however, without a substantial change in ACOEM�s > process of guideline development and dissemination, we have > no choice but to oppose their use by public and private > payers. > > Todd Sitzman, MD, MPH, Immediate Past President American > Academy of Pain Medicine > > Andrea Trescot, MD, President American Society of > Interventional Pain Physicians > > Milton Landers, DO, PhD, President International Spine > Intervention Society > > Jaimie M. Henderson, MD, President North American > Neuromodulation Society > > Joshua Prager, MD, Immediate Past President North American > Neuromodulation Society Chair, Neuromodulation Therapy > Access Coalition > > The authors have responded to directly to ACOEM and have > made their more detailed comments available through the > Neuromodulation Therapy Access Coalition�s Web site: > www.neuromodulationaccess.org. > > > Pain Medicine News
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