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8/5/2016 in Blog Categories, News

We have written about the potential to use stem cells to regenerate articular cartilage in this space before.  Now researchers at Washington University in St. Louis have grown articular cartilage using a person’s own stem cells in a moldable 3D synthetic scaffold.  The development is exciting because the scaffold can be molded around the shape of an arthritic femoral head, thus potentially replacing a person’s damaged articular cartilage with healthy cartilage.  If this potential treatment becomes a reality, it could offer an alternative to total hip replacement surgery.  This would be particularly beneficial for patients under 50 years of age with advanced hip arthritis since most prostheses last less than 20 years and replacing a prosthetic hip carries with it greater complications than the original replacement.  While the research is preliminary and has not yet been tested in animals (let alone humans), it is exciting and worth following, especially considering the fact that 322,000 hip replacements are performed annually in the United States alone.

7/29/2016 in Blog Categories, News

What do a 2,200 year-old Egyptian mummy and many Americans have in common?  Sedentary lifestyles.  And the effects are not pretty in either case.  Scholars who examined the mummy using CT scans determined that the man suffered from osteoporosis and tooth decay despite only being 30-40 years old when he died and having lived at a time when both ailments were rare.  They believe his poor health is explained by the fact that he was a priest, which allowed him to be sedentary, avoid manual labor in the sun, and eat a carbohydrate-heavy diet. 

A recent study published in the European Journal of Preventative Cardiology and reported on in numerous news outlets demonstrates how perilous the effect of a sedentary lifestyle is even today:  researchers concluded that the effect of being unfit “on mortality was a strong predictor in our population, second only to smoking.”  So deleterious were the effects of unfitness that researchers found men who were fit but suffering from high blood pressure and high cholesterol were less likely to die prematurely than men with normal blood pressure and normal cholesterol who were unfit. 

The study involved 792 men who were followed for 45 years starting when they were 50 years old.  Researchers measured the participants’ maximum oxygen uptake capacity, known as VO₂ max, to establish baseline fitness.  VO₂ max is a useful proxy for fitness because it is partly influenced by genetics but increases with increasing aerobic fitness.  The men were divided into three groups:  low VO₂ max, mid VO₂ max, and high VO₂ max.  The men were followed every 10 years, with analysis of cause of death among participants who passed away.  Researchers concluded that the mid VO₂ max group was 21% less likely to die of premature causes than the low VO₂ max group and that the high VO₂ max was 42% less likely to die of premature causes than the low VO₂ max group.  The results remained even when controlling for blood pressure and serum cholesterol.  Lead author Dr. Per Ladenvall summarized the findings thus:

We found that low aerobic capacity was associated with increased rates of death. The association between exercise capacity and all-cause death was graded, with the strongest risk in the tertile with the lowest maximum aerobic capacity. The effect of aerobic capacity on risk of death was second only to smoking.

The findings should give us pause to consider how we approach health care and maintenance.  Rather than relying on pharmaceutical or surgical interventions to control the effects of unfitness, perhaps we ought to insist on interventions that increase fitness.  If being unfit causes premature death and disease, it would seem wise to treat the cause rather than the effects.  As a corollary benefit, the treatment for being unfit, i.e. being physically active, is certainly cheaper than treating the effects, i.e. weight-loss surgery, prescription statins, diabetes medications, blood pressure medications, cardiac bypass surgery, joint replacement surgery, etc.  No doubt increasing fitness in the general population would also have a positive effect on medico-legal claims, since some injuries would likely be prevented and recovery from those that occur would be better in a fit population than an unfit one.

Employment-related meniscus tears are among the more common worker’s compensation claims.  The reasons are myriad but are influenced by the fact that most people develop degenerative meniscus tears as they age and the mechanism of injury for an acute tear merely involves twisting the knee, which can occur in even the lightest and most sedentary occupations because all workers who are not wheelchair-bound walk which means all workers are at risk of twisting their knee in a slip, trip, or fall at the workplace.  Setting aside the possibility that such an event is idiopathic, if a worker seeks medical treatment for knee pain following an industrial event and a meniscus tear is discovered on an MRI the treating physician usually relates the tear to the event.  Standard treatment in most such cases is usually surgical excision of the loose or torn meniscal tissue, more commonly known as a meniscectomy.  The assumption driving the surgery is that the meniscus tear is causing the knee pain and resecting the tear will eliminate the pain.  The problem with this scenario is that most meniscus tears are degenerative and there is no high quality research demonstrating that meniscectomy is an effective treatment for degenerative meniscus tears.  In fact, when researchers recently studied the question they found that exercise was equally effective as meniscectomy to treat knee pain in the presence of a degenerative meniscus tear, according to results published in the British Medical Journal (“BMJ”).

In the worker’s compensation setting, the argument is often made that an industrial event extended a preexisting degenerative meniscus tear in order to justify the surgical intervention (and coverage of the procedure under a worker’s compensation insurance policy).  The cost of meniscectomies to the worker’s compensation system is substantial.  The medical expenses alone are significantly higher for surgery than for conservative care.  In addition, meniscectomies often result in some permanent partial disability.  For example, a meniscectomy in Wisconsin carries with it a 5% minimum PPD rating to the lower extremity at the level of the knee and under the AMA Guides a meniscectomy typically results in at least a 1% impairment rating.  Surgery also typically necessitates a period of temporary total disability in non-sedentary workers.  The findings of the BMJ study should give every employer and worker’s compensation insurer pause and an editorial advocating systemic prohibition of using arthroscopy to treat knee pain that appears in the same issue should spur change.

First, a few things about the study itself.  The BMJ study is a level 1, properly designed randomized controlled trial.  This is the highest category of medical studies and is considered to produce the best and most reliable evidence available.  The BMJ study was conducted in Norway and was a randomized control trial with two parallel intervention groups of 70 patients per group.  One group received exercise alone and the other group received partial meniscectomy alone.  The participants were 35-60 year old persons of both sexes with a 2+ month history of unilateral knee pain without a major trauma but with a verified medial meniscus tear verified on MRI and no worse than grade 2 arthritic changes on x-ray.  The study found that there was no difference in outcomes between the two groups at 3 months and 24 months post-intervention.  The meniscectomy group reported better function and greater participation in sports and recreation at 12 months post-intervention, but the effect was gone by 24 months.  The authors could “not exclude the possibility that the greater placebo effect from surgery on patient outcomes” may have “mask[ed] the ‘real’ difference in treatment between the groups,” which they postulated could explain the temporary effects observed in the meniscectomy group.

More striking even than the study findings is the accompanying editorial.  The authors of the editorial call for a systemic level rule to prevent unnecessary knee arthroscopies from being performed to treat knee pain.  As they note, in the last decade:

A series of rigorous trials, summarized in two recent reviews and meta-analyses, provide compelling evidence that arthroscopic knee surgery offers little benefit for most patients with knee pain.  The latest nail into what should be a sealing coffin appears in a linked paper by Kise and colleagues (doi:10.1136/bmj.i3740):  a rigorous comparison between exercise alone and arthroscopic partial meniscectomy alone (without any postoperative rehabilitation) in adults with degenerative meniscus tear.  The authors found no between group difference in patient reported function at the two year follow-up…

The editorial authors note there has never been high quality research supporting meniscectomy in an older population with degenerative meniscus tears, but that the procedure was extended to this population based on unverified assumptions:

With no support aside from biological rationale, the indication crept from locked knees in young patients to all patients of all ages with knee pain and meniscus tears of any sort; tears which, on magnetic resonance imaging, have proved poorly associated with symptoms. 

The conclusion they reach is both astonishing and harsh:

We are at the point where any careful scrutiny, by, for instance, public health administrators or officials of an insurance company, would conclude that the estimated two million arthroscopic partial meniscectomies undertaken globally each year at a cost of several billion US dollars is potentially nothing but medical waste. Because frontline practitioners and local commissioners have not responded appropriately to the evidence, it follows that system level measures that result in more appropriate use of scarce medical resources are necessary—and perhaps urgently required.

In short, the authors believe the evidence against arthroscopy to treat knee pain is so strong and the evidence for it is so weak that health systems as a whole should stop paying for these procedures.  Such a rule would have a significant impact on worker’s compensation claims where meniscectomies are routinely performed to treat degenerative meniscus tears.

Choosing the right IME doctor can be challenging, especially in complex claims or those with unusual injuries.  Numerous factors influence the decision-making process.  However, two of the most important factors include familiarity with the injury or condition at issue and knowing the precise claims at issue.  These factors are particularly important because many injuries or conditions can be treated by different specialists and it can be difficult in these cases to figure out which specialist is truly the most qualified and credible for the claim at hand.   In simple terms, merely knowing the diagnosis is not enough.

For example, an orthopedic surgeon may amputate toes in a diabetic foot infection claim, but if the cause of the infection is themain issue an endocrinologist, infectious disease specialist, or podiatrist may be better able to write a detailed, credible report as to what caused the infection.  The reason is simple:  orthopedic surgeons do not treat diabetic foot problems unless amputation is required.  The treatment of diabetes, infection risk, and diabetic foot infection management are handled by other specialists.  On the other hand, if permanent impairment is the main issue then an orthopedic surgeon may well be the best expert to use because they are uniquely qualified to evaluate the effects of surgeries they perform.

A similar situation arises in the context of moderate to severe traumatic brain injury.  A neurosurgeon will typically treat the initial injury, but once the condition has stabilized and requires no further surgical management care is usually transferred to a rehabilitation specialist (or more than one).  Once rehabilitation and recovery are complete, care is transferred again, often to a neurologist and a psychiatrist.  In addition, neuropsychologists are often involved in the rehabilitation and recovery process to assess mental functioning.  If the main issue in the claim is the extent of permanency and the type and nature of future care, a neurosurgeon would be of limited value.  However, if the issue is the appropriateness of care in the critical post-traumatic period, a neurosurgeon would obviously be the most qualified expert.  Yet another iteration may involve questions over the extent of mental impairment, in which case a neuropsychologist would be the most qualified expert. 

Facial injuries involving the eye can be difficult also.  The initial treatment may involve an ophthalmologist and a plastic surgeon.  Once the emergency treatment is completed, care may be transferred to a different ophthalmologist for treatment and management of long term vision issues.  Severe ocular injuries can precipitate neurological issues as well, especially headaches.  Sinus and nasal problems can also be present.  In such complicated cases, the actual issues must be examined to assess which experts to use.  For example, in a penetrating eye injury where the patient claims he cannot return to work an ophthalmologist may not be the best choice where the failure to return to work is unrelated to vision loss.  In penetrating eye injuries, the loss of intraocular pressure can precipitate headaches with position changes.  If the claimant was a laborer who routinely has to bend over or look up, a neurologist may very well be the best expert to assess whether the work conditions would in fact precipitate headaches that would prevent the claimant from returning to his employment.  Again, knowledge of both the injury and the actual claim being made are necessary to make the best doctor choice.

Choosing the right doctor is often vexing.  Making the most informed doctor choice not only requires knowledge of the type of injury or condition, but also the precise issues or claims being made in relation to the injury or condition.  To make an informed doctor choice, it is important to recognize that the seemingly obvious specialist might not actually be the best choice depending on what exactly is at issue.  Hence, being familiar with both the injury or condition and the precise issues involved in the claim are necessary to make the best doctor choice.

Claims for worker’s compensation benefits or personal injury damages require a health condition and a mechanism of injury that caused it.  Too often the connection between the health condition complained of and the alleged injury is weak and unscientific.  A large part of the problem is that we don’t perform large-double-blinded prospective studies on what occupational movements, activities, or exposures cause injuries and adverse health conditions.  As a result, most medical experts have little academic literature to rely on when determining whether a particular mechanism caused a particular injury or health condition.  Instead, most experts rely on their experience and training alone to evaluate causation.  In so doing, most experts make logical analyses that would be considered common sense conclusions drawn from the available facts.  This is problematic because what we intuitively believe to be correct based on logical analysis is often incorrect.

How do we know that our intuition is often wrong?  We know because the medical literature is replete with instances in which commonsense, logical assumptions were proven wrong once they were actually tested.  One example is the long-held and erroneous belief that running is bad for one’s knees.  For many years, there was near consensus among medical professionals that long distance running would cause arthritic changes in the knees because of the increased load that running placed on them.  Logically this makes sense because running does radically increase the load on the knees and many things respond to increased load by wearing faster.  A car engine that constantly revs higher than another will wear out faster.  Rapid, hard braking wears brake pads faster than gentle braking from slower speeds.  The problem is that studies found that long distance running does not cause premature arthritic changes in the knees.  How do we know this?  Studies have been done which demonstrate that the incidence of osteoarthritis of the knee is the same in long distance runners as it is in non-runners.   Commonsense logic was wrong.

The link between consuming butter and heart disease is another example of how commonsense logical analysis and intuition proved to be wrong.  We know and have known for a long time that serum cholesterol (the cholesterol in our blood) is associated with a higher incidence of heart disease.  What we assumed is that foods high in cholesterol would cause an increase in serum cholesterol.  Why did we make this assumption?  Because it is logical.  We assumed that serum cholesterol had to come from somewhere and the logical source must be our diets.  Unfortunately, this assumption was wrong.  According to the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report), “Available evidence shows no appreciable relationship between consumption of dietary cholesterol and serum (blood) cholesterol.”  A more recent study concluded that butter had no effect on heart disease.  So what does cause high cholesterol?  According to Dr. Steven Nissen, Chair of Cardiovascular Medicine at the Cleveland Clinic, “Most circulating cholesterol is produced by the liver. Dietary cholesterol accounts for only about 15 to 20 percent of blood cholesterol. Changing the diet typically has only a modest effect on serum cholesterol levels.”  The bottom line is that commonsense logic was wrong, again.

The challenge is how to change the way medical experts evaluate medical causation.  To the extent that medical literature does exist, it would seem that developing standards consistent with sound scientific evidence is appropriate.  For example, “The Twin Study” (subscription required) analyzed degenerative lumbar disc changes among twins with different environmental exposures.  The study was multinational and multidisciplinary, taking place at research centers in Canada, Finland, and the United States.  The study concluded that,

The once commonly held view that disc degeneration is primarily a result of aging and “wear and tear” from mechanical insults and injuries was not supported by this series of studies. Instead, disc degeneration appears to be determined in great part by genetic influences. Although environmental factors also play a role, it is not primarily through routine physical loading exposures (eg, heavy vs. light physical demands) as once suspected. (Emphasis added)

In essence, the research found that occupational exposure to lifting does not cause lumbar disc degeneration.  Nevertheless, medical experts routinely attribute degenerative lumbar disc changes to wear and tear due to an occupational history of heavy lifting.  Commonsense logic suggests this should be so, the actual science does not. 

Many claims, however, fall outside areas in which there is clear scientific evidence.  In these cases, it would seem appropriate to demand medical experts issue opinions that go beyond mere conclusion.  For example, in many rotator cuff tear claims there is a significant degenerative component.  Frequently the medical experts simply state that the alleged mechanism of injury caused the tear or conversely that the tear is solely related to a preexisting degenerative condition.  These opinions are not particularly useful.  Instead, one would like to see the medical expert offer an explanation based on how the alleged injury would impact the anatomy of a shoulder with a degenerated rotator cuff.  This would ideally involve an analysis of the forces involved and how they would stress the tendon fibers that actually tear.  The rotator cuff is made up of four tendons that surround the humeral head.  Presumably specific forces to specific parts of the shoulder would be required to cause injury to the different tendons.  If the supraspinatus is torn, which is the usual suspect, then it would be helpful to have an explanation of how the alleged injury caused the tear or conversely how the alleged injury could not have caused the tear.

So how do we get such an opinion?  The simplest answer is to ask for it.  Instead of simply asking whether an alleged injury caused a condition, ask for an explanation as to why the mechanism of injury was sufficient or insufficient to cause the condition, including an explanation of the anatomical forces involved.  Not every medical expert will give the best answer, but at least if they are asked for an explanation one will typically be given.  Also, it makes sense to ask the expert to identify support for his or her conclusion in the relevant medical literature.  This way, we can inject reason into the process instead of dealing purely with assumptions and conclusions.  

In many claims, the recorded statement is the first and only time a claims professional has to hear what the claimant has to say about the incident precipitating the claim without the presence of counsel.  As such, it provides a unique opportunity to gather information and develop a record of sorts against which the facts of the claim can be judged.  Unfortunately, recorded statements are often cursory, covering a checklist of questions without securing much in the way of detail about the incident and the claimant’s level of functioning pre- and post-incident.  Part of the reason is the checklist of questions.  They are often slavishly adhered to rather than used as a guide for areas that the claims professional wants the claimant to discuss.  In addition, the checklist often becomes an unnecessary attentional anchor for the interviewer, causing him to interrupt the claimant and direct her answers toward staying on script.  This is problematic because most of the academic literature and the most cutting edge law enforcement practices find that the best form of questioning is open-ended, allowing the person being interviewed to describe things in at most a lightly interrupted narrative form.

Wired Magazine recently published an article on the changes being implemented at the federal level and in some local police departments to the traditional mode of interrogation.  The article holds insights for conducting recorded statements.  Obviously the stakes are higher in capital criminal cases such as the one profiled in the article, but the lessons apply to all forms of interviewing witnesses.  The author reports that a huge problem with modern interviewing is that “standard interrogation technique can be an ineffective tool for gathering lots of useful and accurate information” because many witnesses “clam up.”  If the person being interviewed feels like they are being interrogated, they will offer as little information as possible.  This is problematic because the purpose of a witness interview, whether of a claimant in a civil case, a suspect in a criminal case, or a third party witness in either case, is to gather as much information as possible.  As the article puts it, the more a witness says, “the more that can be checked against the record.” 

So how would you go about doing this?  It is really quite simple.  The gist “is this:  If you want accurate information, be as non-accusatorial as possible.”  In other words, build rapport with the witness and remember that the purpose of the interview should be “ geared … toward the pursuit of information.”  Other interesting findings from current research is that asking witnesses to describe events in reverse chronological order is harder to do when they are lying.  It is believed that the increased cognitive load of fabricating a story or facts makes descriptions in reverse chronological order particularly difficult.  In addition, when witnesses lie or fabricate they are not able to provide the same level of detail as truth tellers.  According to Steven Kleinman, who works with the High Value Detainee Interrogation Group, a joint effort between the FBI, CIA, and Pentagon, “No matter how good the cover story is, it’s not going to be as rich as a real-life story.”

The article explains how the new interrogation techniques were put to use to solve a crime in Los Angeles.  In that case, a man, Gabriel Campos-Martinez, was suspected of killing his partner, but the evidence was too circumstantial to allow for charges to be brought against him.  Just over two years after the crime was committed, two LA detectives again interviewed Campos-Martinez, this time using non-accusatory, rapport-building interview techniques.  As a result, the suspect spent 5 hours with the detectives after telling them he only had a short time to speak with them.  It seemed “almost like [the suspect] appreciated the chance to talk. As the hours went on, the conversation started to go in unpredictable directions.”  He eventually revealed critical details that ultimately led to charges and his conviction for the murder.  During the course of the interrogation, the suspect “started to reminisce” about walks he and his partner used to take in the area where the body was discovered, which was new information.  In addition, the suspect described a plant that is used to make herbal tea but in greater quantities can be used to incapacitate, which proved crucial to his conviction.  

It is possible for claims professionals to accomplish the same thing when taking recorded statements.  Build rapport and let the witness talk.  There will always be time for wrap-up questions to ensure that the basic identifying information makes it onto the statement.  But instead of going through a checklist from the start, it might be better to ask open-ended questions that let the witness open up.  Instead of asking a witness if they have hobbies, which is sort of an antiquated term anyway, ask her what does she like to do?  Try having the witness start from a point away from the incident and ask them to describe what happened working backwards.  Pay attention to the detail provided.  The point is that people like to talk when they don’t feel like they are being interrogated.  Build rapport.  Don’t accuse.  Get to the truth (or ferret out the lie).

5/20/2016 in Blog Categories, News, Treatment

We are inundated with messages about the opioid crisis in America.  According to the CDC 28,000 people died due to opioid overdose in 2014, at least half of which occurred while using prescription painkillers.  There is also evidence that heroin use is increasing as prescription opioids become harder to obtain.  In fact, the CDC reports that prescription opioid painkiller use is strongest risk factor for heroin addiction.  Those in the worker’s compensation field have seen firsthand the devastation addiction to prescription opioids can cause.  In addition to the tragic human costs, cases involving long term prescription opioid painkiller use often have high economic costs that include significant lost time and failure to return to work in addition to the cost of the prescriptions themselves.  And this doesn’t begin to touch on the cost that are imposed on the social safety net when long term opioid painkiller use turns into permanent disability.  The bottom line is that an effective alternative to prescription opioid painkiller use in chronic pain cases would improve lives, improve society, and most importantly save lives.

The Journal of the American Medical Association (“JAMA”) recently published a report addressing whether mindfulness-based stress reduction might be that effective alternative.  The report notes that the CDC recommends physicians “try nonpharmacologic and nonopioid therapies first,” before using opioid painkillers.  Hence, it is becoming imperative for physicians to explore alternatives to simply prescribing painkillers.  According to the report,  “limited research indicates that mindfulness meditation for pain management therapy has promise.”  For example, a recent study found that adding mindfulness meditation to a standard pain treatment program increased the percentage of patients who reported meaningful pain reduction from 26.6% to 44.9%.  Obviously this is a significant finding.  Unfortunately, there are no studies that compare mindfulness-based stress reduction directly with opioid use.  The report stresses the importance of performing direct comparison, double-blinded, randomized studies to measure the effectiveness of mindfulness-based stress reduction compared to prescription opioid painkillers.

So why does mindfulness-based stress reduction appear to help at all?  There are a number of reasons, but chief among them is the understanding that “pain is a complex phenomenon involving more than a direct nerve impulse from the affected tissue or limb to the somatic sensory cortex” and that “a person’s thoughts and emotions also play a role in pain perception.”  This has helped physicians to focus on treatment modalities that “shift chronic pain treatment from a ‘biomedical disease model’ to a ‘patient-centered’ model focused on ‘patient engagement in daily self-management.’”  The key is shift between improved quality of life versus elimination of pain, which is often impossible.  This turns the patient’s attention away from pain and disability and toward behavioral and psychological interventions and techniques to improve her quality of life.  In the words of a mindfulness meditation study participant, “I felt the pain was there, but I was able to let it go. I didn’t dwell on it so much.”

Whether mindfulness-based stress reduction will prove to be a substitute or an effective alternative to prescription opioid painkillers remains to be seen.  Nevertheless, the growing awareness that chronic pain is different from and needs to be treated differently than acute pain is positive.  The trend is moving toward interventions in chronic pain patients that focus on learning strategies to cope with their pain which in turn increases their ability to function at higher levels.  And higher levels of functioning mean less catastrophizing, less disability, and ultimately, less death.  A happy coincidence is that it also means a reduction in worker’s compensation costs. 

5/13/2016 in Blog Categories, News

Compound or compounded medications, especially those used to “treat” pain, have been on the rise in medico-legal claims for several years.  Often compounded medications use ordinary and inexpensive drugs in a topical solution but cost an extraordinary amount when compared to their pill-form counterparts.  A CBS News investigation examined the cost of compounded medications.  One patient, Michael Picard, received a one month supply of compounded creams for pain, migraines, and scar reduction.  The total cost for a 30 daily supply of the creams was $18,680.  The scar gel alone cost over $12,500 and contained ordinary medications such as fluticasone proprionate (Cutivate, a corticosteroid), gabapentin (Neurontin), prilocaine HCL (a topical anesthetic), and levocetirizine dihydochloride (a third generation antihistamine).  Only one medication, Freedom silomac anhydrous gel, is actually medication targeted to lessen the appearance of scars.  Inclusion of anti-seizure medication (gapabentin), an antihistamine, a topical anesthetic, and a corticosteroid for scar reduction strains credulity.  Charging over $12,500 for these medications in cream form simply shocks the conscience.

Before delving further into the problems of compounded medication in medico-legal claims, it helps to know a bit of background on what compounded medications are, why they were developed, and why they fall outside of the FDA’s regulatory purview.  The terms “compound” or “compounded” medications refer to medications that pharmacies or pharmacists create which use nonstandard formulations of drugs tailored to individual patient needs.  The original purpose for compounded medications was to provide medication in a form or formulation for patients that otherwise could not use standard formulary drugs.  For example, a medication may need to be compounded for a patient who is allergic to an ingredient in the standard formulary drug or a medication might need to be produced in liquid form for a patient who cannot swallow the standard pill formulary.  Compounded medications in these situations obviously make sense and serve an undoubtedly legitimate purpose.  Unfortunately, compounded medications have come to be used in cases where their utility and necessity are questionable.

The FDA does not regulate compounded medications because the medications are supposed to be formulated on a patient-by-patient basis to be specifically tailored to individual needs.  This means that compounded medications are not standardized.  Hence, the FDA simply lacks the resources to evaluate compounded medications because there is no standard formulary to be evaluated.  When the FDA evaluates a drug for approval, the testing process goes through a number of phases all of which are designed to determine that the drug is both safe and effective.  This is a complicated, labor-intensive process that only works in the case of standard formularies.  It would not be feasible for the FDA to test or require compounded medications to go through this process because the agency could never test all the compounded medications and the pharmacies making them would never be able to afford running the drugs through the approval process. 

This lack of oversight has been exploited as an opportunity by some pharmacies and physicians as a way to increase profits by using compounded medications, for which they can charge more than if they prescribed standard formularies, without being subject to the same oversight for efficacy that would be the case if they were attempting to create a new standardized formulary drug.  The medico-legal world, especially worker’s compensation, is especially vulnerable to the increasing costs of compounded medication because many worker’s compensation laws do not allow for preapproval of medical treatment, including prescription medication.   In California, worker’s compensation billing for compounded medications increased from $10 million in 2006 to $145 million in 2013, an increase of 1,400%.  In some cases, the temptation to reap exorbitant profits has been so great as to spawn criminal conspiracies.  The prosecutor in a California case noted that “workers’ compensation insurers would be billed in ‘the $1,500 to $3,000 range’ for creams that had a resale value of about $70.”  The markup prompted a sophisticated kick-back scheme in which $25 million was paid out to pharmacists, doctors, and chiropractors.  The conspiracy was estimated to have resulted in $100 million overbilling to the California worker’s compensation system.

California is not alone.   The U.S. Military’s health insurance plan, Tricare, paid $1.75 billion for compounded drugs during its 2015 fiscal year (subscription required).  According to a Wall Street Journal, this was “18 times the amount paid three years earlier.”  Certainly we are seeing increased questions about compounded medications here at Medical Systems as well.    Part of the problem is the way bills are processed in many worker’s compensation cases.  According to Phil Walls, chief clinical and compliance officer with myMatrixx, a pharmaceutical management company in Florida, compounded creams are common in worker’s compensation cases “because other systems – such as Medicare – have built in controls such as deductibles and preauthorizations for medications, and worker’s compensation doesn’t.”  To combat the problem, Express Scripts stopped covering many of the creams because there is no evidence that they actually work.  Dr. Steve Miller, Express Scripts chief medical officer told CBS News, “If you talk to almost any pain expert, they'll tell you these things are working strictly through a placebo response and not through a physiological response through the pain receptors.” 

So what can be done about compounded medications and creams in worker’s compensation cases?  Independent experts could be engaged early in the process to review the reasonableness and necessity of the medication early on.  In addition, if the compounded creams do not result in any functional improvement, an independent evaluation may be useful.  Employers and insurers that use pharmacy benefit services such as Express Scripts may have some leverage in compounded medication claims.  The bottom line is that the earlier in the process that compounded medications can be dealt with, the better. 

Any person who spends time in claims has run into files in which a patient with back pain has undergone “provocative discography.”  The procedure involves injecting intervertebral discs suspected of causing the claimant’s pain with fluid along with “healthy control” discs.  Purportedly, if the claimant feels an increase of pain in the suspected disc compared to the “control” discs, then the suspected disc is confirmed as being the cause of the claimant’s back pain.  The problem is threefold.  First, studies have determined that provocative discography cannot do what it is supposed to do.  It cannot identify “discogenic pain.”  Second, studies have definitively concluded that not only is provocative discography an ineffective diagnostic tool but also that it causes the degeneration of injected intervertebral discs to accelerate.  Third, a recent study published in The Spine Journal (subscription required) found in a 10 year study that provocative discography performed on persons without back complaints actually led to back pain and surgical intervention.  Healthnewsreviews.org has an outstanding piece about the study and the lack of coverage in the health news media.  This is important because even today, with knowledge that provocative discography is an ineffective diagnostic tool, 70,000 procedures are performed annually in the United States.  Anyone involved in medico-legal claims should read the Healthnewsreviews.org piece.  Here are some of the highlights:

Experts say that provocative discography has no proven benefit for identifying symptomatic discs and has previously been shown on magnetic resonance imaging to be associated with faster degeneration of injected discs. The new study followed 75 patients who received the injections and compared them to 75 matched controls. The point of the new study was to see whether the disc degeneration seen on MRI would translate into clinically important back pain symptoms.

There was no significant history of back pain in either group when the study began. But the new 10-year data showed that there were more back pain surgeries (16 vs. 4); more frequent sciatica and back pain syndromes, and greater work loss and doctor visits for low back pain in the punctured discs compared to controls.

Such is the import of this study that an orthopedic surgeon interviewed as part of the article flat out stated:

“But readers should be aware that a trial of this sort with 10 years of follow up is very compelling evidence of discography’s potential problems,” Rickert says. “Such long term studies are rare,” he adds, and this one should tell readers: “Do not go undergo provocative discography.”

Perhaps the best summary was provided by another doctor consulted for the article.  Steven Atlas, MD, MPH, told Healthnewsreviews.org:

So, not surprisingly, results are not very reliable. We also know that patients who have fusion based upon findings of provocative discography don’t do any better than individuals who have surgery but don’t undergo this test. We also know that patients can report more pain after the procedure, including pain they didn’t have before the procedure. And now we know that there are long-term risks associated with discography.

The article is worth reading in its entirety.  One hopes that discography and its costs, both direct and indirect, will soon disappear from the health care landscape.  In the meantime, claims professionals should expect their IME doctors on back pain cases to be familiar with the study and use it in their reports when treating physicians recommend or actually perform provocative discography and use it to diagnose the cause of back pain and the need for surgery.

Medical Systems recently held a lunch and learn at Lombardi’s Steakhouse in Appleton, Wisconsin at which hand surgery expert Jan Bax, M.D. discussed common hand injuries.  During his presentation, Dr. Bax alerted attendees to a recent white paper from the American Academy of Orthopaedic Surgeons (“AAOS”) that reports a moderate level of medical evidence links computer use to the development of carpal tunnel syndrome (see p. 222).  As Dr. Bax pointed out, the paper was published in the last couple of months so its ultimate effect in the worker’s compensation arena is undetermined.  Nevertheless, Dr. Bax expressed concern that the paper will lead to renewed carpal tunnel syndrome claims based on repetitive computer use (keyboarding and mouse use).  He noted this is especially troublesome because the hand surgery section of the AAOS considers it a settled issue that computer use does not cause carpal tunnel syndrome.

The white paper assigns levels of evidence supporting the various factors that are sometimes alleged to cause carpal tunnel syndrome.  The highest level of evidence is “strong,” which requires consistent evidence from two or more high quality studies.  The second highest level of evidence is “moderate,” which requires consistent evidence from two or more moderate quality studies or evidence from a single high quality study.  This is the level of evidence the AAOS finds for the position that computer use causes carpal tunnel syndrome.  The second lowest level of evidence is “limited,” which requires consistent evidence from two or more low quality studies, one moderate study, or insufficient/inconsistent evidence recommending for or against the diagnosis.  The lowest level of evidence is “consensus,” which requires that there is no reliable evidence but rather is based on unsupported clinical opinion.

As Dr. Bax noted, finding that moderate evidence supports the link between computer use and carpal tunnel syndrome is troubling because it is actually is a high level of evidence and may sway triers of fact despite the nearly uniform position of actual hand surgery specialists that there is no such causal link.  This is especially true given the findings in some of the research cited.  Coggon, et al., specifically stated that there was an “absence of association with the use of computer keyboards” and noted this “is also consistent with the findings overally from other research.”  The researchers concluded that “obesity and diabetes, and the physical stresses to tissues from the use of hand-held vibratory tools and repeated forceful movements of the wrist and hand, all cause impaired function of the median nerve” but that computer keyboard probably only focuses attention on symptoms without being injurious to the tissues of the wrist.  Coggon, et al. seem to support a more nuanced relationship between computer keyboard use and carpal tunnel syndrome than is portrayed in the AAOS white paper.  Likewise, Eleftheriou, et al. studied the link between computer keyboard use and carpal tunnel syndrome but related the following disclaimer:

One limitation is related to [the study’s] cross-sectional design which does not allow us to conclude if the association between cumulative exposure to key-board use is of causative nature.  The study included workers present when the study was formed, which implies a possible selection bias as is the case in all cross-sectional studies, especially if the study population was affected by high turn-over.  It’s a limitation of our study that we don’t have data on actual turn-over of the staff…Further, we didn’t control for possible confounding factors like anthropometric characteristics of the wrist… 

Eleftheriou, et al. reported only “a possible association between cumulative exposure to keyboard strokes and the development of [carpal tunnel syndrome]…”  They specifically noted that additional studies need to be done to verify their results and to address causality.

The AAOS white paper is a troubling development in carpal tunnel syndrome worker’s compensation cases since it potentially throws into question the settled opinion among hand surgery specialists that keyboard use does not cause carpal tunnel syndrome.  As Dr. Bax noted at the recent Medical Systems lunch and learn, it is too early to tell exactly what the effects of the paper will be, though they are not likely to be positive.  In the event that the AAOS white paper is cited to support work-related carpal tunnel syndrome cases among keyboard users, it will be critical to choose experts who understand and can explain the limitations of the evidence on which the paper relies.  Without an expert who will vigorously question and thoroughly refute the evidence, the AAOS white paper is likely to carry more weight in keyboard-related carpal tunnel syndrome claims than it otherwise should.  

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