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.

Uncle. I give up. Full surrender. Total capitulation. I cannot beat the takers.

It’s funny because my first three drafts of this missive started out “stop the madness”, but I can’t. It won’t stop. The “Do-Gooders” and “We Shoulders” who make the decisions because “they think” or “we feel” have beaten me. Beaten everyone like me. The white flag is up. Turns out the windmill is really a dragon, and contrary to what it says in all the fairy tales the dragon always wins.

You see I, Dr. Quixote as it turns out, thought that being right made a difference. I thought that data, precedent, FACTS would rule the day. Silly me. Silly, sorry sad little me. I thought it was about patients, patient outcomes, statistics, but all along it’s been about the system and protecting the system, protecting it from the very possibility of theoretic risk, protecting it from…patients.

Here I was looking at yet another cost being added to the experience of my surgical patients and asking why a change was being made. Why were we opening a new bottle of $13.00 eye drops for each laser patient, when each bottle held enough medicine for 100 patients? Why were we using a new vial of antibiotic to be injected into the infusion bottle of each case, when each vial held enough medicine for 5 cases? Why, indeed, when there had never…not once…been a reported case of acquired infection, ever, from using one bottle or one vial. Ever. When eye doctors in their offices use and have used, bottles of eyedrops until they can’t squeeze our a single extra molecule. Why?

I blanched at the waste. Plastic baggies of bottles full of drops carted to the trash. Vials of man’s best antibiotics less the microliters used for one surgery crowding the sharps buckets. It was unconscionable, an insult to Puritan and non-adherent alike. The amount of waste nothing short of vulgar.Did no one else see this? I mean, here we are in the supposed throes of a healthcare crisis born of excess and waste, and yet I, Dr. Quixote, flailed alone?

Data…surely data would prevail. Look at the cost, I cried. Never mind the insult to the Puritan ethic, simply look at the cost! You can’t bill the patient, though Lord knows you’ve “mistakenly” done so innumerable times. It’s a cost. It decreases “revenue in excess of expenses” (you’re a non-profit…I get it…we can’t call it profit). I even understand why you’ve spurned my entreaties about Pre-Admission Testing even though there was an article in the New England Journal of Medicine that said PAT is unnecessary. The NEJM is the only medical journal that God reads, and even SHE knew I wouldn’t win THAT one because you can get PAID for PAT. I get that one.

You’ve beaten me. Today I see it. You sent in the REAL decision maker, one of the people who make the decisions in this new age of medicine. I was still under the illusion that maybe I, a doctor, was a decision maker. That I, a doctor who looked at and liked real data, had a vote, some skin in the game. No, today you sent in The One From Pharmacy. I have seen the One With Power and now I know that I am beaten.

The One From Pharmacy has all the words. He has all the weapons. “It’s only fair that each patient receive the same freshly opened bottle/vial.” “What if we have an infection and we re-used a bottle? How could we ever face that patient?” “Here’s an article by a pharmacist that says you could possible have contamination of an open bottle.” “Should we ignore this article that discusses the theoretic possibility of infection?” I also know from prior conversations with The Hospital Administrator that The One From Pharmacy cannot abide not knowing the destination of each drop, cannot abide not having the option of charging each individual patient (if only he could) for each medicine, and that a new bottle must be opened and assigned to each patient for this purpose. This I know.

Oh, I tried. I really did. I tried to point out that each of the articles the The One From Pharmacy shared with me were nothing more than opinion pieces, essays that were little more than editorials sharing one author’s thoughts. His or her feelings. “I think,” therefore it must be. But…but…but…there’s no DATA. No evidence. Nothing to refute decades of experience in the operating room. No results or reviews showing that the status quo is dangerous, only some somebody who managed to get what “they think” into some non-peer reviewed journal.

“Doctor, are you saying that we should just IGNORE these articles? You would have us simply continue with business as usual? The governing bodies ALL say this COULD happen. Are you saying that we should ignore what they THINK?” I confess, I had no answer. I was paralyzed, caught between my horror at the thought that decades of success, as well as common sense so obvious it made stomach hurt, were to be tossed aside because of some someone’s feelings, and my fascination at the sheer revulsion registering on the face of The One From Pharmacy. Funny, he wasn’t anything at all like what I thought the dragon would look like.

I stood there for a moment, bleeding, as the realization slowly came to me that I was defeated. Vanquished. It’s a shame, really, because doctors of my generation are the last, best hope for all of us. We bridge the divide between the ancients who lived through the Golden Age of Medicine–the Giants who cured polio, discovered antibiotics, replaced joints–and the moderns, the nextgen who will live through the silicon age of medicine–Dwarfs who will serve a system, cure the economics, replace care.

I felt small, diminished, inconsequential, a failure, a disappointment. It was hard, frankly, to haul my carcass to the operating room to begin my work day. Yet that’s exactly what I did. I mounted my steed and raised my lance; slowly, ever so slowly, we rode alone to the operating theater.

A white flag, attached to my lance, waving in the breeze.