Tuesday, October 9, 2012

PA Court Entertains Novel Concept: Risk to the Patient

Next month I deliver presentations to the American Academy of Orthopedic Surgeons who gather annually to get continuing education credits and to further their understanding of issues involved in workers' compensation.

The presentations are legally oriented with the intent to introduce some concepts to the physicians that they either are not aware of or need some context in which to put the knowledge to use.

One of the points I make is that workers' compensation is a political construct that uses legal fiction to obfuscate medical science to underwrite a financial proposition.

That it is a political construct can not be argued - there is no common law equivalent to workers' compensation. It is solely a statutory scheme derived from political bargaining where some aspects make sense, and other aspects have questionable validity but nevertheless become part of the system as a consequence of the bartering and deal making involved in politics.

California's recent reform legislation is a prime example.

There are several legal fictions. One is that disability can be measured in financial terms - that a certain body part's impairment results in the payment of indemnity.

Another is that a particular form of treatment is "reasonable and necessary to cure and/or relieve the injured worker from the effects of an industrial injury."

Lawyers love the terms "reasonable and necessary" because those terms can not be accurately measured - they are deliberately subjective to fit a myriad of factual patterns, an example of obfuscation of medical science.

Medical science is nearly inarguable that opioids in their various flavors are highly addictive, and not well suited to the treatment of back pain complaints, particularly when it is "off label" use.

Fentanyl is approved for the treatment of stage IV cancer patients with intractable, and irresolvable, complaints of pain as they await their final day. There is a high risk of addiction to the medication and other physical/mental consequences. If the patient is terminal, such as in a stage IV cancer situation, then the consequences are nominal relative to the overall outcome.

But if the patient is not terminal, then such powerful drugs can make the patient terminal prematurely.

Such is the case with thousands of opioid overdoses a year, which is why there has been such a public outcry over pain medication prescription and management.

The courts are tasked with orienting the subjective standard of "reasonable and necessary" to any given set of facts to make case law.

The Pennsylvania Commonwealth Court, in a decision last month, seized upon the highly addictive nature of the painkiller, as well as the availability of alternative forms of palliative treatment, to rule that fentanyl lozenges were not a reasonable and necessary course of treatment for a worker's back injury.

What was not reasonable and necessary about the prescription of fentanyl in the case was that, true to the nature of the drug, an intolerance level was achieved thus driving the injured worker to increasing dosages with no demonstrable benefit.

While Bedford Somerset MHMR v. WCAB (Turner), No. 1997 C.D.2011, is being appealed to the Pennsylvania Supreme Court, the question is not really whether fentanyl is proper, reasonable or necessary, but the standard upon which the underlying court made its factual determination.

Lawyers on the case are arguing over whether the medication meets that legal standard, but the facts of the case are that the utilization review doctor opined that the medication was not reasonable and necessary.

Turner had sustained an injury to her back in December 1987 while working for Bedford Somerset MHMR. She later underwent two surgeries, including a failed spinal fusion, and was diagnosed with arachnoiditis – an inflammation of the membranes that surround and protect the nerves of the central nervous system and various other conditions which all can be sources of severe pain.

Her doctor, Dr. Balkissoon Maharajh, prescribed her a topical form of fentanyl, to be administered every three days, and a lozenge form, to be taken four times daily.

Bedford requested utilization review of all of Maharajh's treatment. The reviewing doctor, Harold K. Gever, concluded that Turner's use of fentanyl in lozenge form was not a reasonable and necessary treatment because that medication is only approved for pain associated with cancer due to its highly addictive nature.

Turner sought review before a workers' compensation judge. At trial she testified that she had tried at least 12 different medications before the fentanyl lozenges, and they had all either been ineffective in controlling her pain or were not tolerated by her stomach.

She said she suffered from headaches, vomiting and gastrointestinal problems when taking Oxycontin, Oxycodone and MS Contin, and that she is allergic to morphine.

Maharajh, who is board-certified in internal medicine, said that he was closely monitoring Turner and that she was not abusing her medications [though Turner went from three pills a day to eight or nine per day in a matter of two years and ran up a pharmaceutical bill of $170,000 in 15 months]. He warned that Turner was likely to develop withdrawal symptoms if she had to stop taking the fentanyl, but that he thought he could develop an alternative medication regimen which did not include the drug, with the help of a pain specialist (which would cause me to ask, then why wasn't an alternative regimen attempted after nearly 2 years of increasing dosages without relief?).

Bedford presented the testimony of Dr. Marc Adelsheimer, who is board-certified in rehabilitative medicine, and opined Turner's use of the fentanyl lozenges was excessive. He said patients taking the drug quickly build up a tolerance and start to require increasingly higher doses, as demonstrated by Turner's use of the lozenges.

The workers' compensation judge accepted Adelsheimer's opinion and concluded the fentanyl lozenges were neither a reasonable nor necessary treatment for Turner's back condition.

The Workers' Compensation Appeals Board reversed the judge, stating that the "we do not believe that (Bedford) has put forth sufficient evidence to meet its burden of proving that the fentanyl lozenges were not reasonable and necessary."

The appellate court reversed, finding that the workers' compensation judge relied upon substantial evidence, that the board impermissably "retried" the case by ignoring the judge's factual findings, and that "(I)n determining the reasonableness and necessity of a prescribed medication, it is entirely appropriate for a UR reviewer to consider the risk to the patient."

Risk to the patient - what a novel concept.

A former workers' compensation judge whom I consider a good friend of mine once opened a talk with the observation that, "Workers' compensation is the only medical benefit delivery system where it is often expected that the patient will be worse off after treatment."

Fortunately the Commonwealth Court of Pennsylvania doesn't buy into that statement.

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