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.

The onus for reducing healthcare costs has been placed squarely in the middle of the backs of physicians. At the same time, physicians are being graded on how well they “satisfy” their patients. Rock, meet Hard Place. Hard Place, Rock.

Two recently published studies referenced pretty much everywhere have shown that individual patients specifically do NOT want to take cost into consideration when it comes to making decisions about their own care. In addition they also do not want their physicians to give any consideration to cost concerns when diagnosing or treating their own illness. Indeed, when given the choice between two treatments of nearly equal efficacy, study subjects overwhelmingly chose the more expensive option for themselves even when the difference in efficacy was very small.

While the authors of the articles citing these studies were shocked at these findings, the only surprise in my mind is that anyone is the least bit surprised by any of this.Think about it. You will personally pay little to none of the difference in cost of the treatment out of your own pocket for a treatment or a test that someone has labeled “better” or “more effective”. You’re telling me you’re not gonna choose that one? Please.

The two great forces aligned against one another in the “Healthcare Reform” debate advocate respectively: market-based incentives in which a patient is given better information in return for shouldering more of the financial decision-making and the importance of the quality of the exerience, and top-down command and control strategies in which both carrots and sticks are applied to doctors in an attempt to get them to provide better care with a more friendly consumer experience while at the same time spending less money. Physicians must provide more and better for less, and must do so under the same zero-sum malpractice game of “GOTCHA” rules we have now.

All of the responsibility for lowered costs with better outcomes and a better quality experience for the patients is shouldered by docs in Obamacare. Accountable Care Organizations (ACO) are lauded for paying physicians a set salary rather than by work done. Unless, that is, you do less work, quality notwithstanding. Getting great outcomes, following best practices, and receiving high satisfaction marks get you a pay cut if you see fewer patients, generate lower test fees, or do less surgery. The Rock.

Play by the rules, see your prescribed load of patients, get great outcomes and practice to the letter of evidence-based medicine, but fail to get those high customer satisfaction marks? Ah…welcome to the Hard Place. Your pay depends on satisfying your patients. Meeting their expectations both for their experience as well as their care. You know, those same patients who only care about the cost of someone else’s healthcare, not theirs. Fail to order the test that rules out the 0.00001% chance of that rare tumor on Anderson Cooper Live last night? BZZZZZT. Bad doctor. 1 out of 10 on the patient satisfaction survey and a trip to the principal’s office to learn about your pay cut.

Man. It wasn’t enough to be in the crosshairs of every plaintiff’s lawyer under the sun (so Doctor, isn’t it possible that you might have saved this patients vision if you’d ordered that MRI to evaluate her headache?). Nope, now we are responsible for balancing the Federal budget while simultaneously giving every patient whatever care they’ve seen on Dr. Oz (“PET Scans–your doctor KNOWS you need one if you have a headache! You could go BLIND!!”). It’s a lot to ask of your doctor.

Unless, of course, it’s someone ELSE’S headache.

I have been pretty generous in sharing my thoughts about some of the ills of our American Healthcare system, especially with regard to the barriers erected between physicians and patients. I find the various proposals now before our legislative bodies in Washington to be rather curious, even offensive. Since when does the United States of America adopt wholesale an economic solution from another country? Especially another country that is in some way otherwise riding the considerable coattails of the U.S. economy?

The “baby with the bathwater” approach in the halls of our Capitol and the editorial offices of our leading media outlets (WSJ excepted) is about as wrong-headed as you can get.  What we need is an AMERICAN solution to the challenges that we presently face with the economics of healthcare in the U.S., using our present system as the foundation.

Not surprisingly, I have some thoughts!

1) Malpractice tort reform. See my thoughts in “Tort Reform = Healthcare Reform”. Effective reform will dramatically reduce the scourge of defensive medicine with its attendant costs and risks to patients. Defensive medicine represents 15-25% of all medical costs in the U.S. That’s 15-25% of $2.5 Trillion. Do the math. While we’re at it, how is it good for the country to allow the tort bar to advertise for cases? Rake the muck in the hopes of unearthing errors or imagined?

2) Tax Reform #1: Remove the tax deduction for employer-offered health insurance. Provide a 100% TAX CREDIT to the lowest 60% of wage earners for the purchase of health insurance. Provide a progressive TAX DEDUCTION for the upper 40% of wage earners.

Tax Reform #2: Remove the tax deduction for advertising as a business expense for Hospitals. If we are concerned about unnecessary increased utilization of medical resources why are we allowing advertising by hospitals? For that matter, remove the tax-exempt status of any hospital or  provider that advertises. How is it appropriate to allow a hospital system to advertise to increase revenue, deduct that advertising as an expense, and still be not-for-profit? If it looks like a for-profit business, acts like a for-profit business, and sounds like a for-profit business, tax it like a for-profit business.

3) Insurance Reform #1: Reverse all of the for-profit conversions of previously not-for-profit health insurance companies. Who was the genius who thought THIS was a good idea? I don’t remember insurance premium increase that were quite so massive when all of the Blue Cross/Blue Shield plans were not-for-profit, do you? And while there were $Million execs in the non-profits I don’t recall any $10, $20, or $100 Million execs. Removing the need to answer to the stock market will create companies that will compete quite nicely with the for-profit companies without the horror of a government run system. Let the equivalent of NGO’s compete with the United Healthcares of the world.

Insurance Reform #2: Remove state-level coverage mandates and create a minimum federal set of mandates for comprehensive insurance policies. A REAL minimum. REAL medically necessary items. No Viagra or artificial  insemination coverage. Allow cross-state competition for the business. Real competition always drives prices lower.

Insurance Reform #3: Allow insurance companies (Medicare and Medicaid included) to discriminate IN FAVOR OF people who make healthy lifestyle choices (eg. no nicotine, no DUI, etc.). We are all so afraid of the stick that we refuse to allow any use of the Carrot.

4) Freedom of Speech/Restraint of Trade Reform #1: Abolish, once again, direct-to-consumer pharmaceutical advertising. There was a quantum leap in the utilization of all sorts of medications immediately following the 1997 rulings that allowed DTC pharmaceutical marketing. If it is so obvious that our ever-increasing levels of spending on medical care is a threat to the very existence of our fair Union, then DTC drug marketing is a version of yelling “FIRE” in a crowded theater.

Freedom of Speech/Restraint of Trade Reform #2: Begin a return to the professionalism of yesterday by prohibiting all forms of advertising by, or for, physicians. The AMA gets a lot of criticism, most of it well-deserved in my opinion, but the court and FTC rulings that prohibited the AMA from censoring physicians who advertised was a seminal event in the de-professionalism of doctoring and medicine. Doctors and other medical advertising was, is, and always will be wrong. While we’re at it, do the same thing for the rest of the lawyers and the practice of law.

5) Public Health. Finally, and most importantly, go to the true root of whatever “Crisis” we may have here in the United States, be it a “Healthcare Crisis” or a “Healthcare Finance Crisis” or what have you. We as a people are not healthy; certainly not as healthy as we ought to be. We are not healthy because of some wrong-headed previous Public Health decisions (simple-carbohydrate based diets, abolition of school phys-ed programs, tort-fearing closures of playgrounds, etc.). We are not healthy because our ability to treat the diseases that result  from poor lifestyle choices (cigarette smoking, alcohol abuse, preventable accidents, etc.) is SO GOOD that we are able to keep more and  more unhealthy people alive longer and longer, paying ever more to do so along the way.

This is where true leadership can make a difference. Remember JFK and the President’s Council on Fitness? I do. 8 pull-ups in the fifth grade for me. Polio, measles, smallpox and whooping cough were once the leading killers of children in the U.S. but are now historical footnotes due to Public Health initiatives. (A pox on all the cretins advocating against childhood immunization).

We lead the world in per capita alcohol related accidents and deaths, losing young lives by the thousands each year. We have ever more increasing numbers of truly obese citizens who go on to suffer the diseases caused by that obesity, and we pay ever more for their diabetes, hypertension, strokes and heart attacks. These lifestyle choices are root causes for our increased expenditures on Healthcare, much more so than all of the targets of Beltway demagoguery like insurance company expense ratios and pharmaceutical company profit margins. A solution to this issue, more than all of numbers 1 through 4 combined or any other proposal yet floated, is the true crux of the solution to any “Crisis” we may be facing. Everything else is only there to buy time. Time to get healthy.

Pick a number; choose an age. 40. 50. 60. Anyone under that age gets “Well-care” or “Get Healthy Care” starting right now. Over that age they can have “sick care” only if they wish, but under that age if you try to be healthy you get rewarded.

There are no votes to be had in making Americans healthier. Nothing but hard work on every side of the equation. Who will stand up and do the hard work? Who will lead?

Who will have the guts to not only say that the Emperor is naked,  but also drunk and fat and puffing away our economy.

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?