Random Thoughts from a Restless Mind

If you practice Evidence-Based Medicine (EBM), or religiously follow a Preferred Practice Pattern (PPF) such as one published in a white paper by a specialty society or organization, you and your patients can be assured of one very important fact: you are providing care that is neither up to date nor care that can be described as “Best Practices”.

You might be increasing the likelihood that your patient’s medical insurance will pay for their care, in part because insurance companies have already figured out how to make money on older treatments and protocols. I guess you can feel good about that, or at least feel good that your staff won’t be forced to fill out all of those appeals forms when state of the art care is denied. So you’ve got that going for you. What used to be considered good enough care might feel better to you if your patient isn’t avoiding the older treatment because of payment issues like they do with the newer. Adherence to some care is better than non-adherence to “Best Practices”, right?

There are certainly some of you out there in doctor land who think that citing EBM or fidelity to a PPP will inoculate you from medical malpractice tort. Sadly, nothing is further from the truth. Not only will your adversary nullify a PPP by citing a “Standard of Care” that is up to the minute when it comes to how to treat literally anything (though as we know “Standard of Care” is neither Best Practices nor EBM), but there are so many instances of EBM not allowed as evidence at trial that it’s nearly useless to try. Even the strongest body of research can be nullified at trial by introducing a single non-peer reviewed study with opposite findings to a naive jury of lay people.

EBM and PPP are the result of years of studies that were launched based on prevailing thoughts at that time. They are subject not only to what is fashionable among the medical intelligentsia, but also what is fundable. The potential ROI from the industry side of the medical pie has a direct impact on not only what is studied but what treatments are available at all. A company with a blockbuster drug that has years of patent protection remaining will be unlikely to support the study and use of its own competitor or successor until under the gun of generic competition. Governmental funding of maladies without either a popular champion or sympathetic victim is slow in coming, if it arrives at all. Both EBM and PPP enter the public arena only after months or years of time spent “in committee” with old data.

At the end of the clinic day both EBM and various PPP’s suffer from being out of date on the day they are published. Because of this they create at least as many problems as they attempt to solve. In addition to providing ammunition to insurers all too happy to avoid paying for newer, more effective care that might be more expensive, the wide dissemination of various articles on EBM or PPP’s can sow confusion and doubt in the minds of those patients most in need of Best Practices, particularly those with severe or complex problems.

Any specialty in medicine could provide examples, but since I’m an eye doc let me offer one that illustrates most of the nuances involved. We’ve long known that elevated tear osmolarity (salt content) is a component of dry eye (DES). Prior to 2009 testing the osmolarity of human tears required a complex, time-consuming process that also suffered from the twin-blade cut of being both expensive and not covered by any insurance plans. Consequently the use of tear osmolarity as a core diagnostic test in the care of DES was pretty much a non-starter.

In 2009 TearLab introduced a much simpler, much less expensive test that could be done in the course of a regular office visit, and in 2010 the company received a waiver from the FDA which allowed doctors to use the test in an office setting without being certified as a clinical laboratory. Approval for payment by insurance companies, including Medicare, came shortly thereafter. As with any new test that becomes widely available it took a couple of years for clinicians to figure out the full extent of the meaning and application of the results. The short version of this part of the story is that tear osmolarity testing has become an integral part in both the diagnostic work-up and ongoing follow-up of DES patients in any advanced DES clinic due to its clear therapeutic value. It also fits into the prevailing financial model and patient mindset in which diagnostic testing is an insurance covered benefit.

What’s the problem then? Our largest professional organization, the American Association of Ophthalmology (AAO) publishes a series of PPP’s addressing many common entities in eye care, and DES is one of them. The latest version was published in 2013 after more than a year of discussion in committee based on practice patterns  and publications from 2011 when Tear Osmolarity was not yet in widespread use. The PPP made much of the fact that this at the time new test had not yet been widely adopted and that there was still some discussion about its true clinical worth. BOOM! In rushed a Medicare administrator in January 2015 with a proposal to withdraw payment for this “non-essential” test of “unproven” value.

The problem, of course, is that Tear Osmolarity is now widely and quite rightly accepted as a part of today’s “Best Practices” of DES care. Ironically, the use of Tear Osmolarity is actually an example of EBM, but that evidence has emerged subsequent to the initiation of the PPP process. Removing insurance payments will erect a barrier between patients and their best chance at treating their disease.

Thought leaders in my field as well as other, more nimble professional organizations than the AAO have offered assistance to TearLab to prevent a change in the insurance payment for tear osmolarity testing. Both eye doctors and their patients will likely survive this misguided attack on an extremely useful technology. It does make one wonder how many other instances exist where a seemingly good idea (PPP, EBM) is misused in the eternal battle between those who provide medical care and those who are charged with allocating the monies used to pay for that care. Funny, isn’t it, how the medical powers that be, professional organizations like the AAO, are always a bit behind the times, and the payment powers that be (and often plaintiff’s attorneys) use that to their advantage?

Preferred Practice Patterns and many examples of Evidence Based Medicine need to come with an expiration date, or at least a warning that using them cannot be construed as either “Best Practices” or cutting edge. Even at the time they are first published.

They got it half right. The jury that is. The jury in the malpractice case in which I just served as an expert witness got it exactly half right. Kind of like our whole medical malpractice court system if you think about it. A young woman had a bad outcome in one of her eyes following eye surgery, an outcome that has caused her quite a lot of unhappiness, quite a lot of difficulty. The jury was quite correct in recognizing this, and also quite correct in recognizing that this woman was going to need some financial help in order to make this difficult situation even a little bit better. In order to make this happen the jury found the doctor who performed the surgery guilty of medical malpractice.

Only one problem with that, though: no true malpractice actually occurred.

Herein lies the essential, fundamental problem with our medical malpractice tort system as it is presently constituted. Every single malpractice case is a “zero–some game” in which the only way that an individual who has been injured or otherwise suffered a bad outcome from some medical experience can receive financial help is for some doctor (or hospital) to lose a malpractice case. As an aside, the plaintiff’s attorneys, the lawyers who represent the victims of medical misadventure, must win the case in order to be paid. (The full–disclosure necessary here is that the only people who are guaranteed to be paid are the defense attorneys and the expert witnesses on both sides of the case.)

I’ve actually been up at night, literally losing sleep every night since the conclusion of this trial. That’s actually kind of odd, and doesn’t really make any sense at all because I received rave reviews for not only my testimony but also for the strategy suggestions I made over the four years it took to bring this case to its conclusion. Indeed, even the court reporter went out of her way to tell the defense team what a great job I had done. It’s kind of like getting all kinds of pats on the back for making 10 receptions for 200 yards in a football game your team goes on to lose–pretty empty feeling despite the fact that you did your part well.

What then, exactly, is medical malpractice? In the civil court system in the United States medical malpractice requires that two things have occurred. First, a doctor (or hospital) must commit an act of COMMISSION (do something) or an act of OMISSION (fail to do something) that falls below the Standard Of Care. This failure to meet the Standard Of Care must then result in some kind of harm to an individual. To be extremely technical and to–the–letter correct, the failure to meet the Standard Of Care is malpractice, and the resulting harm is malpractice liability. No need to get all tied up in that kind of detail; let’s just call the whole thing medical malpractice.

The Standard Of Care is a difficult concept. In effect, the Standard Of Care is defined as that care or medical decision-making that a preponderance of (most) similar practitioners would provide in similar circumstances at that time. Pretty nebulous, huh? Not a terribly rigid, hard, easy to put your hands around definition, and it’s a moving target on top of that. The Standard Of Care is an ever–evolving thing; new research findings, new technology, and new patterns of care will all combine to create a Standard Of Care that may be different today than it was even last year.

In this particular case there was never any question that it was a medical procedure that caused this patient to have such a bad outcome. There was never really even any question about the technical quality of the work performed by the doctor. No, what it all came down to was a question of whether or not the surgery should have been performed in the first place, and thus came into play that subtle little part of the Standard Of Care, the difficulty in describing to a jury of non-–physicians the difference between the Standard Of Care today and that of some years ago. The lawyers for the patient did a brilliant job of burying the jury with the details of HOW the complication arose, the difficulties that have arisen because of the complications, and the uncomfortable interactions that occurred between doctor and patient in the months following the surgery. They confused the jury about the difference between “could have done” (more than the Standard Of Care) and “should have done” (Standard Of Care). The lawyers were able to bury the fact that the Standard Of Care was followed by the doctor in question because at the time of surgery the PREPONDERANCE of similar physicians in similar circumstances at that time would have done the SAME THING.

The jury got it half right.

There, in a nutshell, is everything that’s wrong with our present medical malpractice tort system. In order for this woman, obviously harmed by this procedure, to receive some award so that she can do certain things that will make her life easier, she and her team had to “beat” a doctor and win in court. And oh yeah, she’ll also have to give 40% of whatever her award might have been to her lawyers. I think that’s a big part of why I’ve been having trouble sleeping. Not the lawyer payment thing, but the fact that a doctor who (in my opinion) practiced within the standard of care must now have a black mark against his name so that a patient can get some money that I frankly think she deserves.

Maybe a better analogy of my role in this “competition” would be something more like this: I was the consulting coach brought in to suggest an additional element to a figure skater’s program. Assuming that everyone in the competition was as conversant with the subtleties of the rules involved I suggested that the skater add an elegant, understated movement that would be obvious to any experts on the panel of judges, the jury as it were. Unfortunately, in our American system of medical malpractice, that’s not the case, and the opponents eschewed subtle elegance in favor of multiple quad jumps. The skater I assisted performed totally within the letter of the rules, but was penalized because the jury, the panel of judges, was not really an expert panel and missed the added element. And so he lost.

I DO wonder though what my reaction would have been if the opposing skater who landed all those quads had been the one who lost. Would I be up at night over that, too?