Posted by Sharon Kramer on 1/28/11

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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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