Issue: November 2006
November 01, 2006
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Peer review: now more intrusive than ever before

Learn to manage the stricter peer review systems coming soon via a regulatory system near you.

Issue: November 2006
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Peer review is changing for a reason, and the California workers’ compensation reform has fast-forwarded this process. Aspects of these changes will impact you and your care of patients.

These new reviews may have already come to your area. In keeping with the tradition of learning from each other in orthopedics, I organized this round table of experts to share their insight and experience with you.

Such patient-management issues are impacting us all. Over the past year I have listened and talked to workers’ compensation administrators, a judge, attorneys, insurance executives, physicians and patients regarding the changes within the peer review process in California. This is a summary of some of the reasons expressed to me that caused and were used to change the current “practice as usual.”

(1) Treating physicians are often are biased in favor of the patient in considering cost effective medical care, including disability ratings.

(2) Treating physicians often order unnecessary and/or unproven tests and treatments. In addition, many ancillary tests and services were being done to benefit physicians (conflict of interests) and to protect against medical legal issues.

(3) Guidelines in California that were adapted for acute treatment of musculoskeletal injuries are “presumed correct”. Yet, they were set up with minimal input by surgeons. Guideline developers and contributors were primarily occupational medicine physicians.

(4) Guidelines were designed for the treatment of acute injuries but are often applied to chronic injuries and there is too little literature supporting these applications.

(5) Because there is often a lack of strong research-based evidence for a given treatment, the reviewer will deny a requested treatment.

A denial of a test or treatment can be aggravating to a busy physician and difficult to explain to the patient. The time necessary to appeal either in writing or matching up with the reviewer on the phone is often exasperating.

Douglas W. Jackson, MD
Chief Medical Editor

Moderator:

Douglas W. Jackson, MD  [photo]Douglas W. Jackson, MD
Orthopedics Today Chief Medical Editor,
Memorial Ortho Surgical Group
Long Beach, Calif.

Round Table Participants:

Roger M. Belcourt, MD, MPH [photo]Roger M. Belcourt, MD, MPH
Director of Occupational Medicine Services
Specialty Health, Inc.
Reno, Nev.

Vert Mooney, MD
U.S. Spine & Sport
San Diego, Calif.

E. James Greenwald, MD
Surgical Director
Specialty Health Inc.
Reno, Nev.

James B. Talmage, MD
Occupational Health Center
Cookeville, Tenn.

Douglas W. Jackson, MD: What is a definition of “practice guidelines?”

Roger Belcourt, MD, MPH: Practice guidelines are systematically developed statements to assist practitioner decisions about appropriate health care for specific clinical circumstances. These can simply be broad statements or they can be very detailed based on literature review as well as expert opinion. Typically, clinical guidelines reflect more than local consensus regarding appropriate diagnosis and treatment of a condition. Clinical guidelines also can be developed to describe the indications for procedures and the process of care.

Jackson: What are the American College of Occupational and Environmental Medicine (ACOEM) guidelines? How were they developed and by what groups or individuals?

Belcourt: The ACOEM Guidelines are the only evidence-based guidelines that focus on returning employees to work within 90 days of a workplace injury/illness. The guidelines mainly focus on the first 90 days since approximately 90% of such injuries are resolved in this time period. However, issues outside of the 90-day range are also addressed by the guidelines.

Presenting essential consensus and evidence-based information, the guidelines focus on addressing the injured worker’s functional impairment to safely return him or her to work. The treatment approach encompasses the medical, psychosocial and functional outcomes of the injured worker. The guidelines contain two sections, “Foundations of Occupational Medicine Practice,” and “Presenting Complaints.”

The foundations section reviews prevention; the general approach to initial assessment and documentation; initial approaches to treatment; work-relatedness; cornerstones of disability prevention and management; pain, suffering, and the restoration of function; and independent medical examinations and consultations.

Presenting complaints include those of the neck and upper back; shoulder; elbow; forearm, wrist, and hand; low back; knee; ankle and foot; and eye. A chapter is also devoted to stress-related conditions. The first edition was published in 1997 and the second edition in 2004.

ACOEM’s Occupational Medicine Practice Guidelines, 2nd Edition, was adopted by the State of California. California Labor Code 4600 states, in part, “Occupational Medicine Practice Guidelines, 2nd Edition are ‘presumptively correct’ on the issue of extent and scope of medical treatment unless the requester can prove that the guidelines are erroneous, irrelevant, or legally incompetent. As well, for all injuries not covered by ACOEM, authorized treatment shall be in accordance with evidence-based medical treatment guidelines generally recognized by the medical community.”

ACOEM has attempted to be inclusive of diverse specialties as it relates to contributions to the guidelines. The goal is to be guided by high-grade scientific evidence wherever possible. Since this evidence does not always exist, consensus opinion becomes requisite, and for these decisions, input from multiple specialties (eg, orthopedics, neurosurgery, physiatry, chiropractic, physical therapy, etc.) becomes very important in the construction of these consensus statements.

The American Academy of Orthopaedic Surgeons (AAOS) participated in the creation of the 1st Edition of the ACOEM Guidelines in 1997 approximately 5 years earlier. That contribution has not been diminished by the passage of time according to Lee Glass, MD, JD, who served as editor of the 2nd Edition.

However, AAOS did not respond to repeated invitations to participate in the current (2nd) edition and therefore did not participate in the updating of the ACOEM guidelines.

Personally, I consider this non-participation by AAOS as unfortunate. Of course, expert orthopedic opinion was solicited and included in the Guidelines, however, AAOS speaking as an organization could potentially have been much more powerful.

Jackson: What if a treating physician disagrees with the guidelines?

James B. Talmage, MD: As a patient advocate, if the treating physician disagrees with a treatment recommendation denial that was based on guidelines, the treating physician should appeal the denial decision, and in the appeal articulate why this particular patient is an exception to the guidelines. Examples of this would be asking, ‘How will the requested test change treatment?’ or ‘Why will the requested treatment likely be effective?’

Attacks on the concept of guidelines in general are unlikely to sway a reviewer if the reviewer is asked to evaluate the appeal based on guidelines.

In a workers’ compensation situation, if the state system regulations requires decisions to be made utilizing a particular guideline, generic attacks on that guideline are not likely to change a state mandate.

Most often, when a treating physician articulates his or her thought process, it is logical and permits a reviewing physician to agree with the treating physician. Most often when a treating physician merely attacks the concept of guidelines without providing the requested additional clinical information about his or her particular patient, reviewing physicians have no basis to agree with the treating physician.

“Practice guidelines are systematically developed statements to assist practitioner decisions about appropriate health care for specific clinical circumstances.”
— Roger Belcourt, MD, MPH

Jackson: What are the basics for a reasonable request for a test or treatment?

Belcourt: A reasonable request is one based on evidence, to the greatest extent possible. It also encompasses logic, conformity to evidence-based and consensus peer reviewed guidelines, as well as art. This does not necessarily mean that a request is denied if it does not fit within ACOEM or any other guideline. The key issue is that when proposed treatment does not fit in such a guideline, it is incumbent upon the requestor to present an argument as to why the proposed intervention is warranted in the case at hand.

Jackson: What suggestions could you make to us as orthopedic surgeons in providing evidence-based medical and surgical treatments to our patients?

Belcourt: For several decades now, physicians have been keeping medical records in a manner that could successfully defend them in a malpractice case. We all bellyached about it but eventually got over it and did what we needed to do to limit our liability. Adherence to an evidence-based model is probably the greatest defense in any malpractice claim. With this background, I have several suggestions for orthopedic surgeons.

First, I would encourage each orthopedist to know and apply the evidence as it relates to their specialty. Every attempt should be made to limit anecdote or cite one’s curriculum vitae as the basis for procedural approval. Next, the orthopedist should become very familiar with whatever guideline has governance in their region. In California, for example, this is the ACOEM Guidelines, and I would encourage California orthopedists to have a copy in their office and refer to it frequently.

Lastly, include discussion about why your request is proper and necessary under evidence-based medicine. Instead of composing your reporting for a malpractice attorney, consider what a Utilization Review Physician would need to approve your request and address these issues.

Not only does it limit your malpractice liability, but will result in more of your requests being expeditiously approved. When I review a request, I search for indications in the medical record provided in an attempt to approve the proposed intervention. Some orthopedists excel in documentation and approving a procedure requested by these physicians is quite easy. However, when the discussion is not present in the medical record, it becomes very difficult to approve anything.

Jackson: Would you comment on the paucity of “strong research evidence-based literature” in orthopedics? How are guidelines developed and accepted without it?

Talmage: Ideally guidelines are based on strong evidence. However, in musculoskeletal disorders many times strong evidence does not exist. The more recent orthopedic literature generally does contain stronger evidence. Review of evidence-based medicine published in the Journal of the American Academy of Orthopaedic Surgeons in 2004 indicates that in recent years 7% of articles published in Journal of Bone and Joint Surgery and Clinical Orthopaedics and Related Research are randomized control trials and 1% are prospective cohort studies. These study designs are the strongest evidence available, and are the evidence generally desired for creation of guidelines.

The ACOEM Guidelines, and others like it, state the level of evidence behind recommendations. Many of the recommendations have footnotes indicating they are based only on limited evidence, meaning no randomized controlled trials, or are based on expert consensus. Where there is no high quality scientific evidence, guidelines by default must be based on expert consensus.

Jackson: What about guidelines from other organizations such as AAOS or American Society of Interventional Pain Physicians (ASIPP)? Do any of these contribute to the body of evidence-based medicine?

Talmage: Many organizations are publishing guidelines. The National Guidelines Clearing House is a useful resource to obtain many musculoskeletal guidelines.

The AAOS in the past published guidelines on many topics, but currently the only supported published guideline is on the foot. They are in the process of writing two new guidelines that have yet to be published.

The ASIPP has published practice guidelines. In the methodology section they do not define words like “strong evidence” or “moderate evidence.”

Their conclusions about the evidence for lumbar facet injections, IDET, etc. are radically different than reviewers like the Cochrane Collaboration, the British Medical Journal Publishing Group’s Clinical Evidence, and the European Chronic Low Back Pain Guidelines. The definition of “evidence” used in a guideline is a key fact to understand.

Guidelines that explicitly state methodology and that demand high quality evidence should come to consistent conclusions about the evidence.

Thus, there is a remarkable correlation between the European chronic low back pain guidelines, the Cochrane Collaboration reviews, and the British Medical Journal Publishing Group reviews. When multiple organizations use the same methodology and come to the same conclusion, it should give orthopedists more confidence in the validity of the conclusions.

Jackson: Where is the orthopedic literature supporting spine fusions in the workers’ compensation setting?

Vert Mooney, MD: Most literature attributes back pain to various anatomic causes, but few studies clarify these issues. It is difficult to always identify the appropriate patient. Certainly decompression, which may be so extensive that stabilization is necessary, and demonstrable instability radiographically benefit from fusion. On the other hand, patients lacking justification for decompression or evidence of instability frequently do not benefit from fusion.

This is especially true if there are psychological factors. Of course, there are many workers near the end of their careers who have little hope of maintaining their physical capacity, perhaps in the environment of an unfriendly workplace, who see little reason to get better.

If returning to work is considered a valid endpoint in treating workers’ compensation cases, then fusion offers little potential. Even in one of the best fusion studies — recently presented by Fritzell and colleagues from Sweden on highly selected degenerative disc and spondylolisthesis patients — only one-third of these patients went back to work. I am unaware of any study restricted to patients who do not need decompression or who do not demonstrate instability that has a better track record. Mannion and Elfring recently presented an excellent study defining all of the variables. Classification of the ideal patient is nearly impossible.

Jackson: Should a spine surgeon be involved in the acute care of a work injury?

Mooney: I certainly am aware that many spine surgeons consider that other clinicians should handle early nonoperative care. The practical reason for this opinion is that most nonfracture spine problems resolve without the need for surgical care, and thus the number of surgeries available vs. the number of patients seen is very small. It’s not cost effective from the surgeon’s standpoint.

“Where there is no high quality scientific evidence, guidelines by default must be based on expert consensus.”
— James B. Talmage, MD

On the other hand, when asked if a spinal surgeon should be competent in nonoperative care, either in a deposition or in the form of board examinations, the answer is: Of course. We can’t have it both ways.

Certainly, for a surgeon to make the appropriate judgment to identify the right surgery for the right patient, some awareness of the personality and response to previous treatment should be a necessary component of decision making.

This cannot be achieved if the surgeon only agrees to see the patient when he or she has been defined as a surgical candidate. Would you rather be treated by just a surgical craftsman or a competent clinician with well-trained surgical skills? There is no basis to avoid responsibility for nonoperative care, even in the acute phase.

Jackson: What are the basic indications for an MRI in patients with back complaints?

Mooney: We, of course, are talking about patients who are not undergoing deteriorating neurologic status or with significant neurologic deficits. The MRI is necessary here but most patients have leg and back pain without true neurologic deficit or evidence of significant radiculopathy. These are the ones where an MRI is of questionable benefit. Given the age group of the particular patient, there will be abnormalities seen on the MRI, some of which may be quite significant. However, many studies have demonstrated that even the significant abnormalities may not be associated with symptoms as they occur in individuals who have no complaints at all. Thus, for the large group of patients with no hard neurologic findings suggesting the need for early decompression, the appropriate time for an MRI is after failure of a rational, nonoperative program. In that there are multiple studies indicating that, following lumbar soft tissue injury, inhibition of especially extensor musculature occurs, a rational nonoperative program should include a progressive resistance exercise program. This should be especially focused at the lumbar extensors but should include general conditioning along with aerobic activity. In that such a program expects to achieve physiologic changes, baseline and milestone measurements should be available to document that it has been an effective program. If such a program fails, an MRI may provide some insight. Even then, as all surgeons are aware, the findings may be misleading. It cannot serve as the only decision-making mechanism.

Jackson: What are the practical points for requesting spine surgery?

Mooney: Certainly decompression done sooner than later offers a better potential. Correlation of clinical findings, imaging studies and perhaps even electrodiagnostic studies should allow appropriate patient selection. Proper patient selection becomes blurred when mainly backache with some referred leg pain is the problem.

The burden of selection comes to the nonoperative care. We have got to recognize that the spine functions with similar physiology to the knee. What is the appropriate nonoperative care for a sprained knee? Ultrasound? Hot packs? Exercise to other parts of the body? No. Progressive resistance exercises are standard care. Why not for the spine? Patient compliance and willingness to take responsibility for their own care is a major factor in decision making as to the appropriate surgical candidate for a fusion for back pain.

Those factors can only be determined if the patient actively participates in their nonoperative care. Their level of disability is merely reinforced if all they have is palliative passive care that offers only several hours of benefit. They slowly get the impression that they are incurable. Why not treat a back like a knee?

Jackson: What is the current thinking on the limitation of physical therapy sessions?

Belcourt: A few years ago, in response to out-of-control workers’ compensation costs in California, an administrative mandate was imposed, capping physical therapy and chiropractic visits at 24 for the life of the claim. It is important to note that this is not evidence-based medicine. It is an artificial cut off put forth by a state bureaucracy. In the bigger picture, this should serve as a reminder to organized medicine that if we do not police ourselves, someone else is going to do it for us and we probably will not like it. In some cases (eg, PT trial ending in failed conservative treatment and ultimate surgery with appropriate postoperative PT), utilization review could very well allow for visits over this arbitrary cap, allowing the patient to receive what they needed. To my thinking, it is far better to base our care on the best available evidence, rather than legal mandate.

Jackson: Please comment on the surgical treatment of “mild” carpal tunnel syndrome. Is there a role for workup of comorbidities? If so, how should this be done? What are some of the common pitfalls using electrodiagnostics in this diagnosis?

Talmage: The surgical treatment of real carpal tunnel syndrome should result, absent complications, in excellent results. Decompression of a mildly compressed nerve should eliminate the problem. Decompression of a partially dead nerve in late carpal tunnel syndrome obviously could lead to incomplete recovery.

A problem not well publicized is that electrodiagnostic studies over-diagnose carpal tunnel syndrome (false positive tests). There are many reasons for this. There is no national organization that defines a normal nerve conduction test. Imagine the chaos if each physician chose his or her own blood sugar definition of diabetes.

Most of the published definitions of “normal” nerve conduction studies use two standard deviations from the mean as the definition of abnormal. This means 2.5% of the population would be abnormal on a given test. It is not clear that 2.5% of the population should have diabetes, hypertension, carpal tunnel syndrome or acromegaly, and yet 2.5% of the population will have test results for blood sugar, blood pressure, nerve conduction or growth hormone level that are 2.5 standard deviations from the mean.

The published definitions of normal nerve conductions almost always are based on “convenience controls” or people readily accessible to a university electrodiagnostic testing center. These individuals may not be representative of the population at large.

Many electromyographers diagnose carpal tunnel syndrome despite normal nerve conductions by doing comparison testing of the median nerve to the ulnar nerve or radial nerve. If your left eye does not see quite as well as your right eye, and yet both eyes see better than 20/20, is your left eye diseased?

There are also numerous sources of error in nerve conduction testing. Many error sources are technical and require more time to discuss than this round table permits. In nerve conduction testing, distal latencies are usually reported to 0.1msec (for example, my definition of a medial nerve distal motor latency for an 80-mm distance is 4.3msec or below). A latency that is 0.1msec slower than normal is 1/10,000 sec slower than “normal.”

If there are many potential sources of error in the testing that can introduce easily a 0.2 or 0.3msec error, then test results that are “normal,” but close to abnormal, or that are “abnormal,” but close to normal, are very difficulty to interpret.

“I was amazed to find out how much the employers and the third party administrators knew about individual physicians and their practice patterns.”
— James B. Talmage, MD

The two published studies that have correlated surgical outcome with median nerve distal motor latency with wrist stimulation have indicated there is a predictable good outcome if the median nerve distal motor latency is at least 1.0 msec greater than normal, or is at least 6.0 msec. This conduction delay level is significant enough that surgeons can be sure carpal tunnel syndrome is actually present.

Very mild degrees of conduction delay may indicate that very mild carpal tunnel syndrome is present or may be false positive tests. Thus, the population with these very mild conduction delays contains many individuals who do not have carpal tunnel syndrome and who do not do well with carpal tunnel release. (Surgery for a disease the patient doesn’t have usually doesn’t help much.)

In cases of moderate (conduction block) or severe (axon loss) carpal tunnel syndrome by electrodiagnostic testing definitions, surgical treatment is clearly indicated to save axons. In cases of mild carpal tunnel syndrome with only conduction delay present on electrodiagnostic testing, there probably is a role for evaluation of comorbidities and a trial of nonoperative treatment. These steps require multiple office visits, which allow the orthopedist to know the patient better and check for the consistency of the history. In these very mild cases, the diagnosis of carpal tunnel syndrome is still a clinical diagnosis.

Jackson: In 2003, I wrote an editorial describing certain individuals in our profession who overtreat, order too many tests and do surgery with marginal indications. These physicians were running workers’ compensation mills. From your experience, what are some generic examples of what you have seen when you’re doing reviews?

Jim Greenwald, MD: As far as ordering too many tests, the most common example would be the early and repeated ordering of MRIs. I agree with Drs. Wiesel and Boden who in 1994, in the Journal of the Academy of Orthopaedic Surgeons, described the problems with the early orderings of MRIs in injured workers and the difficulties that ensued: “… Thus, the imaging study could lead to the erroneous conclusion that the patient’s symptoms are related to a finding of no clinical significance.” There were also problems with the early and frequent use of discography that lead patients down a surgical path.

We saw many cases where epidural steroids were done for very high costs, ie, $10,000 per procedure and where patients were referred to injection clinics and repeatedly treated with trigger point injections, facet injections or Botox, etc. and, of course, narcotic abuse, especially OxyContin (oxycodone, Purdue Pharma). Fibromyalgia diagnoses were made and were alleged to be work-related leading to multiple interventions.

“Correlation of clinical findings, imaging studies and perhaps even electrodiagnostic studies should allow appropriate patient selection”
— Vert Mooney, MD

There were multiple claims of chiropractic abuse where hundreds of treatments per patient had already occurred and more were being requested. The most serious problems by far centered on lumbar spine fusions, which have had a dismal track record, in many cases with repeat operations.

For example, fusions were done for back pain only, for the chronic pain patient and in patients who were psychologically impaired. This procedure caused more problems in the California workers’ compensation system than any other.

You mentioned surgery with marginal indications – how about surgery with no indication? One classic example is the repeated incidental decompression of the ulnar nerve when a carpal tunnel procedure was being done and the ulnar nerve was electromyographically normal and gets decompressed anyway. These are just a few examples.

Jackson: It is my impression that a major motivation of all of these changes in the system was to use utilization review to try to limit some of the abusers. Given what you’ve seen, do you agree?

Greenwald: Yes, that’s exactly what we’ve seen in California and that’s exactly what I think has been going on. Once Governor Schwarzenegger signed the reforms and we began to see reviews, there was a heavy concentration of reviews from people who had been identified as abusers.

I was amazed to find out how much the employers and the third party administrators knew about individual physicians and their practice patterns. It is difficult to adequately describe the degree of hostility that employers had towards the individuals who were identified as abusers. In essence, ACOEM became the bible for the claims examiners who took the initial look at the requests. If a request was felt to be incompatible with ACOEM, it would be forwarded for review.

That’s why I think it’s important that organized orthopedics gets involved in upgrading guidelines that accurately reflect our thoughts on the management of musculoskeletal conditions.

Jackson: Should our national organizations be more involved in educating, interceding or reprimanding flagrant abusers of the system?

Greenwald: I think this is a critical question. Many innocent patients have found their lives more complicated because of the abusers. In addition it has impacted all other orthopedic surgeons in California seeing the injured worker. With the real abusers, it isn’t a matter of more education, I’m sure of that. These aren’t uneducated people. I’ve come to the conclusion that actually they are quite smart. They are also devious, articulate and highly organized. They keep up with techniques that are in fashion.

What comes to mind were the IDETs that were frequently used and now some of the requests we’re seeing for the artificial disc. Often their operative notes are extremely detailed, very long and complex. It is only when you have a chance to evaluate a series of patients and see that the operative notes are identical from patient to patient for unusual or rare orthopedic conditions that you understand what is really going on.

I would encourage the academy if it were serious about reprimanding the flagrant abusers – these individuals can be identified. I believe the effort would enhance our reputation, but it would be difficult. The people we’re talking about have probably made an awful lot of money over the years and certainly have a close relationship with the attorneys, so taking them on in an organized fashion might be challenging. Picket’s charge comes to mind – we would be Picket. What California has done is establish networks and used the networks to eliminate the flagrant abusers from the system. At this time, that’s probably the most effective way to deal with them by cutting off their access to the patient in the first place.

For more information:
  • Fritzell P, Hägg O, Wessberg P, Nordwall A. 2001 Volvo Award in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: A multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group. Spine. 2001:26;2521-32
  • Mannion AF, Elfring A: Predictors of Surgical Outcomes and their assessment. Euro Spine J. 2006:15(supp 1)S93-S108.
  • Dr. Talmage has indicated that he is a paid orthopedic reviewer for Specialty Health MCO.