Doctors say ACOEM is a chronic pain. Threaten class action

[Guest guest]

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

Deer, MD, president of the Center for Pain Relief in ton,

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.â€

“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.â€

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

Deer, MD, president of the Center for Pain Relief in ton,

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.â€

“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

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.â€

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 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 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,â€

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.â€

Dr. Sitzman also described the ACOEM panel’s definition of pain—“a symptom

rather than a diseaseâ€â€”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.â€

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.â€

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.â€

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 Grindâ€

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.â€

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.â€

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.â€

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 harmâ€â€”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.

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

Trescot, MD, President American Society of Interventional Pain

Physicians

Milton Landers, DO, PhD, President International Spine Intervention

Society

Jaimie M. , MD, President North American Neuromodulation Society

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_

(http://www.neuromodulationaccess.org/) .

_Pain Medicine News_

(http://www.painmedicinenews.com/ViewArticle.aspx?d=Policy+ & +Management & d_id=83 & \

i=January+2008 & i_id=351 & a_id=9899)