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Doctors are Threatening Class Action against Corporate Controlled ACOEM
by Submuloc
Saturday Jan 29th, 2011 6:27 AM
Pain Management Doctors are Threatening Class Action against Corporate Controlled ACOEM “The insurance companies will buy these guidelines and then cut and paste [the text] on their denials.”
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The pain management physicians are asking for transparency in ACOEM's drafting of guidelines, too. This is from Pain Medicine News. Pulled out some highlights. Complete writing at the end:

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:http://www.neuromodulationaccess.org.

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