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.