As Health Care Learns and Grows…

While grappling with the costs and imperfections of our health care system in recent years, a multitude of experts in the field found it useful and enlightening to compare health care to a variety of more familiar industries, and to suggest that health care should adopt operational models that have been shown to work well in those other industries. From the financial industry, we learned that health care must be computerized. From the restaurant industry, we learned that health care must be standardized. Observing Starbucks, we concluded that clinicians must be taught a few things about customer service. Aviation brought us safety manuals for medical procedures, and NASCAR informed us about the superior power of disciplined teams of workers. The history of agriculture provided important lessons on government’s role in creating bigger and more efficient producers, and from the history of manufacturing we learned everything else we needed to know, from Six Sigma to Lean Toyota to focused factories, and how innovation must begin with cheap products and services that are good enough for all but the wealthy and the narrow minded.

As many of the lessons learned from these industries are being applied to health care, the results are starting to come in and most are shockingly disappointing. A group of researchers from Stanford University is reporting in the May issue of Health Affairs that “an increase in the market share of hospitals with the tightest vertically integrated relationship with physicians—ownership of physician practices—was associated with higher hospital prices and spending”.  A Harvard University paper in the same issue of Health Affairs is predicting that “ACA reforms could result in an additional 4.4-percentage-point increase in profit margins for hospital-based EDs compared to what could be the case without the reforms”. A very large study in Canada recently published in NEJM, found that “[i]mplementation of surgical safety checklists in Ontario, Canada, was not associated with significant reductions in operative mortality or complications”.  And yet both vertical integration and ACA reforms are continuing at a brisk pace.

Back in 2012, a large national study from UC Davis, published in JAMA Internal Medicine, found that “higher patient satisfaction was associated with less emergency department use but with greater inpatient use, higher overall health care and prescription drug expenditures, and increased mortality”. A more recent JAMA Surgery study from Johns Hopkins “suggests that patient satisfaction is not related to standard process-of-care measures that have long been used as markers of surgical quality”.  Also in JAMA Internal Medicine, researchers from the University of Chicago reported that in their study “71.1% of patients preferred to leave medical decision making to their physician” and the remaining 28.9 % of patients who preferred to make their own decisions “had increased LOS of 0.26 day and increased costs of $865”. Patient experience surveys are quickly becoming mandatory and the “patient decision aids” industry is booming.

Yes, the findings in almost every article cited above have been disputed, and a few generated notable literary altercations, none more acrimonious though, than the technology wars. Two years ago a study funded by the Agency for Healthcare Research and Quality (AHRQ) found that physicians in hospitals spent approximately an hour and a half each day interacting with EHRs, and that 16% of their notes along with 38% of nursing notes were never read by anybody. A year later, the American Journal of Emergency Medicine published a study showing that great strides have been made, and in the ED, 43% of physician time was spent interacting with EHRs and 28% was spent interacting with flesh and blood patients. A fascinating new paper from researchers at Northwestern University studied the gazing patterns of doctors during office visits and found that “physicians with EHRs in their exam rooms spend one-third of their time looking at computer screens, compared with physicians who use paper charts who only spent about 9% of their time looking at them”. The market for analyzing all the data collected in lieu of patient care is “poised to skyrocket” from the current $4.4 billion to well over $21 billion by 2020.

In a hot off the presses opinion piece in JAMA Internal Medicine, paid for by a charitable organization controlled by Sutter Health, the venerable Dr. Thomas Bodenheimer is advocating more substantive delegation of clinical tasks to medical assistants who, as a group, are “ethnically and linguistically diverse, and culturally concordant with a variety of patient populations” (I absolutely adore the English language), in order to meet increased demand for primary care and allow clinicians to “see more patients per day”. Predictably, Dr. Bodenheimer concludes that the “enhanced roles for medical assistants is an innovative approach”. Another innovation that is so new and exciting that University of Chicago researchers decided to write a Health Affairs paper about it even before study results were available, consists of primary care doctors who will be admitting and caring for their own patients when hospitalized. The grand innovation here seems to be that patients must first become very sick, presumably for lack of proper medical care, and then and only then, do they get a Comprehensive Care Physician to follow them through the numerous hospitalizations awaiting them. It is comforting to read that this oddly retrograde approach is not posing any theological difficulties with the Holy Scripture of health care reform – The Innovator’s Prescription – which is the embodiment of all we need to learn from retail, manufacturing, technology, etc.

There is no need to shake your head in utter disbelief, because there are very simple explanations to this cacophony of Casino style fun and games, where we all serve as chips and tokens. Yes, money is one explanation, but not the only one. It seems that in a headlong rush to fix things, many people with basically good intentions overlooked a few salient linguistic details.
First, the Marx-Schumpeter paradigm for capital accumulation is called “creative destruction”, not destructive creation, which means that before you take the wrecking ball to what is already there, you must have the new and tremendously improved stuff, working and spreading like wildfire. 
Second, “disruption” is a retrospectively affixed label to a novel business idea that worked surprisingly well, not a prospectively self-ascribed title used for everything people do after they have coffee in the morning. 
Third, business models conceived with an intention to defraud the public are commonly referred to as embezzlement, corruption, larceny or felony in general, and only rarely are they hailed as “innovations”. 
With so many divergent opinions on what ails health care and how to best provide a cure, can we maybe start by agreeing on the terminology we use to disagree with each other?

Translucency with Turbid Clouds

Did you ever read a seemingly inconsequential sentence somewhere and it then just refused to leave your mind for days on end, triggering avalanches of thoughts way beyond the original intent, if there even was one? It just happened to me a few days ago when I read one more industry article about the recent Medicare data dump. The following remark was attributed to a primary care doctor: “The U.S. is entering an era of more accountability and transparency in all aspects of people's personal and professional lives and “medicine cannot be excluded,” he said”.  Back in 1996 a science fiction author by the name of David Brin, published an article in Wired Magazine, where he too prophetically argued that the era of transparency is no longer preventable. Ignoring an entire branch of physics, Mr. Brin suggested that the only antidote to the floodlights shining on each individual consists of a “flashlight” we can use to point at the elites running the lightshows. But Mr. Brin forgot another time honored use of flashlights: we can start pointing them at each other, no doubt to the great amusement of floodlight operators. This has the twofold benefit of keeping us from staring at the floodlights overhead, and of illuminating any subatomic particles that may have eluded the big lights. And there is no better, or more entertaining, place to begin playing with flashlights than medicine.

I won’t belabor personal transparency, since it is tantamount to invasion of privacy, which should be illegal, but it is not. Invasion of privacy in the U.S. is becoming a business model and a method of governance. If you missed the 60 Minutes segment on data brokers on April 9th, here is a link. In the now customary incestuous relationship between big business and government, the Institute of Medicine (IOM) is proposing to help data brokers clean up the dossiers they are compiling on people. Utilizing the Meaningful Use program lever, the IOM will be delegating this task to physicians, so a doctor visit will include detailed interrogation regarding such things as the ethnic/racial composition of the neighborhood you live in (geocodable, of course), sexual practices, exposure to fire arms, employment, country of origin, previous incarceration, and all sorts of important stuff for the Internet business. It will also help employers do a much better job with hiring good people since your doctor will have to note now if you are a conscientious, optimistic fellow, or alternatively a stressed out hostile, angry and dissatisfied individual. The IOM would have liked to add more of these hard to get data points, but they couldn’t find the faintest indication that those things have anything to do with medicine at this time. I’m sure they eventually will.

Professional transparency on the other hand, is a much more complicated issue. If you offer to sell a service or a product, you should expect some scrutiny of the value you provide for the buyer, unless of course, you have the means by which to force people to purchase your service or product. Legal systems have always endeavored to create moral frameworks for protecting buyers from unsavory sellers, and vice versa. The best buyer protection is full disclosure, or transparency, regarding the service or product being sold, coupled with legal accountability for negligent and intentionally fraudulent practices. With this in mind, shouldn’t it be the government’s responsibility, indeed its duty, to provide the public with as much information as possible regarding services provided by physicians? Particularly since medical services are most often not elective, and one could argue that the medical profession, as a whole, has the ability to force people into buying its services under duress. Let’s assume for a moment that the answer to this question is affirmative, and move on to a couple of more specific questions.

First, what is it that people buy from doctors? Roughly two types of things: expert advice or skilled repairs. When you are considering the purchase of these services, it would be very helpful to have an independent assessment of the level of expertise and proficiency at repairing items similar to yours. And of course, you would want to know how much the service is going to cost. In the pre-transparency era, we did our best to infer the level of physician expertise or skills by asking very simple questions: Where did he go to school? How long has she been in practice? What do my friends think about this doctor? Is he “affiliated” with the shiniest academic center in town? Are his other patients smart, educated people, or maybe even doctors themselves? We didn’t ask about cost, but more often we did ask if the doctor accepts our insurance, because doctor fees were a sunk cost for most people with health insurance.

You don’t have to have a Masters in Health Administration to see that even if we managed to obtain answers to all our questions, the dataset would be incomplete and fraught with inconclusive and even misleading subjective information. The Internet made it easier to both ask and get answers to some of our questions, but hasn’t done a thing to improve the quality of information available to us, and maybe the opposite is true, seeing how we are all perfectly willing to take advice from anonymous strangers who have nothing better to do other than to rate things online (when is the last time you rated something on a vendor site?). If the government is to step in and help us pick doctors, it would have to do much better than facilitate availability of social media gossip about this or that physician.

For example, what type of information could assist young parents with picking a pediatrician? Let’s be honest and admit that in addition to simple facts, such as education, years in practice, location, hospital affiliation, you would want to know what other parents think about this doctor, and what other doctors think about her as well. But in order to provide context to these opinions, you would need some objective measures. Do I get the doctor on the phone if I call with a concern, or do I get someone else? Will she always see my kid, or will we have to deal with a bunch of random people? Does she offer well-child appointments that fit my work schedule?  How difficult it is to get an appointment? If my child needs hospitalization, will she be there, or will I be on my own? How good are the physicians that cover for her? How good are the specialists she usually refers to? How often does she refer and for what reasons? How much time will she spend with my child?

And here are the things we wouldn’t need to know, not because these things are not important, but because they are largely implied and too granular to be indicative of substance. How many kids is she testing for pharyngitis and is she properly treating them? How many kids get weighted and have their height measured? How many are asked about smoking or whether they are depressed? How many girls are screened for Chlamydia and how many kids in her practice got all their shots?  And yet, the government is in full swing to deliver exactly this nitty-gritty information, and absolutely none of the answers most people seek, not because the answers we want are not available, or impossible to generate, but because keeping everybody busy looking at the trees may just be enough to detract our attention from the massive forest being erected in our health care backyard. 

You can easily extrapolate this example to adult primary care and specialty care of all types, including tertiary care. How about prices though? Since health insurance has evolved into indemnity insurance for errors in lifestyle, doctor fees are no longer a sunk cost for the majority of Americans.  Most everybody now, has to pay full price or at the very least a percentage of physicians’ fees in addition to insurance premiums. Our young parents may want to factor the cost of seeing a pediatrician into their decision making process for a variety of good reasons, not just because they are looking to care for their baby on the cheap. And here is where the most absurd facet of our health care system makes its appearance. The prices for seeing a doctor are meticulously defined and used by insurers, but doctors are prohibited from divulging them, and the government is doing absolutely nothing to change that.

What the parents in our example need is a simple table with rows listing all the pediatricians they are considering, and columns across, listing what each insurance plan in their area has decided that parents will have to pay each doctor, at least for the most common services (including facility fees, if any). Using this and similar tables for their own health care needs, our little family could make an informed decision not only about which doctors to see, but also which insurance plan they should enroll in. Unfortunately for them, and for their doctors, and for us all, such tables are detrimental to the moneyed interests of big health care businesses, and therefore will not be forthcoming anytime soon. Instead, the government is throwing out bunches of dollar numbers that have nothing to do with anything, implying that there is great wisdom to be found in partial truths, and that we should get busy trying to find the secret keys to said wisdom. 

Armed with irrelevant quality measures about their doctors and deliberately misrepresented price information, patients recently turned consumers are expected to take on the medical industrial complex, very much like mice are expected to attack the cat amusing itself before dinner. Transparency, we are told is a very powerful tool for an enlightened citizenry, and it is. Translucency by design, and turbidity by negligence, which is what we are being served here, are very powerful tools too. Different objectives though….

Our Cheap and Productive Lives

So you think there is a war on doctors, don’t you? It certainly looks that way from your particular vantage point. The government is deftly intruding into your professional life with a computerized fifth column that is extracting information on your every move, and to add insult to injury, it forces you to actually collect the data which is to be used against you in the court of public opinion. Media outlets are stepping all over each other to be first in line with sensational headlines implying reckless abandonment to greed in a profession believed to hold higher ethical standards than most. And the ever louder calls to rein in the seemingly rampant waste, fraud and abuse in health care, are becoming synonymous to reining in doctors’ irresponsible conduct.  The art of rabble rousing has always included oblique references to how the mighty have fallen. What is unique about the modern day twilight of the doctors is that it has practically nothing to do with the doctors themselves.

There really is no war on doctors. There is a war on patients, and doctors are merely collateral damage. You are an exploitable asset, to be bought and sold like cattle, and with you, the “covered lives” that you “control”. In a perfect world the price of acquisition would include orderly transfer of said control to the new owner, but the world is not yet perfect, so for the time being you must be retained as a proxy for the controlling interests in covered lives. You will have to learn new skills because the management of many covered lives is different than the management of the few, or the one. You will be held accountable for the health of your populations, and you will need to exhibit financial stewardship of the scarce resources allotted by the owners. In other words, your job now is to increase the productivity of the covered lives assigned to you, at the lowest possible cost to your employer, and the clients of your employer. These are classic key performance indicators (KPIs) in any business, and health care is no different.

The established leadership of the medical profession is currently on an all-out crusade to prepare the rank and file for their evolving position in this new world order. In April, NEJM published the recording of a roundtable discussion, moderated by Dr. Atul Gawande, which concluded with the heralding of a “new culture in practicing medicine” where doctors “prioritize our responsibilities as shepherds of scarce social resources to the same extent that we’ve historically prioritized our responsibilities for providing benefit to our specific patients”. To reinforce the argument, Dr. Peter Ubel, in an opinion piece titled “Promoting Population Health through Financial Stewardship”, is proposing to take the ABIM Choosing Wisely campaign to new levels and have doctors “contemplate trading off small clinical benefits for individual patients in order to promote more general societal welfare”. Since institutions have a business imperative “to reduce the amount of care they provide to patients” because of new payment models, Dr. Ubel keenly observes that “[i]f physicians resist these efforts because they feel they owe it to their patients to provide the best care regardless of costs, hospitals may look for other ways to trim expenditures, such as by reducing nursing staff”. If you are a doctor, and especially if you are a patient, the enormity of this statement should give you monumental pause.

Why wouldn’t hospitals auction off original artwork hanging in the lobby instead of firing nurses, is largely beyond me, but this particular flavor of financial stewardship, which is benefiting society by limiting clinical benefits available to its members, is all the rage now. Did you ever wonder why insurance companies seemed to not mind Obamacare requirements to place no limits on lifetime or even yearly maximums? Wonder no more. Last month the American College of Cardiology and the American Heart Association published the “ACC/AHA Statement on Cost/Value Methodology in Clinical Practice Guidelines and Performance Measures”. It seems that clinical guidelines are going to sport new value ratings that can be used to inform insurers and policy makers engaged in coverage determinations. Based on the World Health Organization (WHO) methodology, spending over $150,000 per quality adjusted life year (QALY) will be designated as low value care. The American Society of Clinical Oncology is working on its own financial stewardship guidelines, coming soon to your iPhone. Obviously insurers could just restrict coverage based on these ratings, but oh how much better it would be if doctors just refrained from prescribing these treatments on the QT.

For their part, distinguished economists, who practice their dismal science in the health care domain, are also searching for tools to help doctors manage their assigned populations. Writing for the New York Times, Prof. Uwe Reinhardt is lambasting Congress for its reticence to assign formal monetary value to the lives of people. There is implicit bulk valuation when covered lives are transacted, of course, but what you need at the bedside is patient-centered, personalized value estimates for each patient profile. How else will you decide if there is acceptable ROI when contemplating small clinical benefits? There is a rather humorous exercise in demagoguery, mistakenly attributed to George Bernard Shaw, which states that our seemingly moral convictions are not based on principles, as much as they are based on the amounts paid to us for transgressions. Following this irrefutable logical argument, Prof. Reinhardt is suggesting that it’s time for Congress to stop feigning indignation, and that it should take a lesson from the venerable Milton Friedman and put a price on every human head.

Walmart is promising to bring organic food to the masses. Walmart will make organic food affordable for the poor. What a wonderful idea! For Walmart that is. Small organic farmers are going to be forced to accept cheap Walmart prices and increase their “productivity”, or agree to sell their farms to industrial farming corporations. Maybe former organic farmers can get a job at Walmart, stocking shelves with pseudo-organic foods. Before you know it what passes as organic foods will be as lousy as regular foods, only a bit more expensive. Walmart is the future of all commerce because Walmart doesn’t just sell cheap replicas to unsuspecting poor people. Walmart is also nurturing and growing the poverty necessary to attract new customers. And this travesty is precisely the model chosen as the blueprint for fixing health care in America.

Caveat Emptor

For the longest time now I was of the opinion that the entire patient engagement movement is much ado about nothing, either stating the obvious, or demanding the impossible. I changed my mind. The emerging realities of health care in the U.S. are rendering patient engagement imperative, except for those patients who are participating in programs like, say, Penn Passport, a Penn Medicine product advertised as “a great resource for people who value their health care”, which includes Pavilion services complete with “warm cherry cabinetry, soothing earth-toned fabrics, comfortable elegant furnishings and convenient in-room safe” (the safe did it for me). For all others, it will be up to each and single one of us to advocate for ourselves in an essentially adversarial system. Perhaps a new profession will emerge, and perhaps patients would be best advised to bring an attorney to the exam room.

Dear Mr. and Mrs. Average Patient, since you are unwilling or unable to properly value your health care, the system will do the valuation for you. To ensure that the services you receive at industry venues are clinically appropriate for your situation, you must engage in independent and sustained research of your condition. This is particularly important if you are poor, old, disabled, very sick, or illiterate. Most of your research can be done on the Internet. If you can’t afford a computer, the public library will provide one for you. If you don’t have a car, most buses will have a stop in proximity to a public library. It is imperative that you keep notes and actively question all therapies offered to you and most importantly, those that are not. You should insist on real-time, online access to your medical records. Not some generic summary, but the full notes outlining the thoughts (if any), differentials and considerations made by those in charge of shepherding your scarce resources.

You could try to find a tiny private practice that is “in-network” with your insurer and pray that they take new patients, or you could scrounge together a few dollars, and go find a cash-only physician that may be willing to advocate for you. But the best thing you can do is to take a more expansive approach to patient engagement, and stand up for yourself and your family in this abject, immoral and underhanded war on the American people. The only thing that stands between you and cheap pseudo-medicine that looks fine from a distance, and full of holes upon closer inspection, is your doctor. No, doctors are not saints, and a few are outright villains, but taking away the ability of your doctor to exercise independent judgment on your behalf, is not intended to benefit you, or society for that matter, unless by society, you mean the six Walmart heirs, and their peers. You may be tempted to think that physicians are wealthy enough and powerful enough to ward off attacks from without and from within on their own. You would be very wrong. And is this really a health risk you are willing to assume? It’s time to engage….

Brace Yourself for Transparency

It’s here. For the first time in 35 years (or 33, depending on which click bait headline you clicked on), the much anticipated data on Medicare payments to physicians, has been released to the public, on the historic date of April 9th, 2014. “Data trove shows U.S. doctors reap millions from Medicare”, according to the distinguished Reuters news service. The Washington Post will tell you “[e]verything you need to know about today’s unprecedented Medicare pricing data dump” and Pro Publica, which specializes in rendering doctors transparent, is announcing more tools for picking doctors coming soon, based on these data. If you want to read juicy stories about a handful of crooks who happen to have a medical license, and who were already under investigation by Medicare, click on some of the links above or below. If you want to understand what this all means to you, stay with me and keep reading.

The data released by Medicare includes the doctor’s name, address and specialty. For each physician, there is a list of CPTs performed for more than 10 patients during CY 2012, and for each CPT there is the number of unique patients billed for the procedure, the number of times the procedure was performed (or billed to Medicare), the average charge per CPT and the average payment for the same. There are over 800,000 names on the list (not just physicians), so chances are good that unless you are a pediatrician or a concierge doc, your name is on it. Of course, this is just the preliminary raw list, but given enough time and innovative efforts, many, many sub-lists will be evolving. Even before the list was released to the public, several publications with advanced media access, managed to quickly produce high-spender lists, so stay tuned to your favorite news outlet for more to come. Until then, the New York Times has the best search tool, so go ahead, look yourself up. It’s OK; everybody else is doing it.

One thing to note is that the data does not include Medicare Advantage patients, so right off the bat almost a third of Medicare patients are excluded from this data trove, not to mention the exclusion of Medicare Advantage bonuses from our newfound transparency. So if you find a geriatrician that reaped only $2,056 from Medicare, try not to worry too much. Chances are the guy or gal is fully loaded with Medicare Advantage patients. Commercial payers are obviously not on the list, but neither is Medicaid. We all know that Medicare payments are just the tip of the iceberg and doctors get additional boatloads of money from private insurance, and if we don’t know, I’m sure we will be so advised by the media in the next few days. But in the interest of full transparency, wouldn’t it be enlightening to see Medicaid’s relative contribution to doctors’ wealth? I mean defrauding the elderly is pretty bad, but defrauding hungry children, should give the upcoming three-part expose pieces so much more oomph….

On the White House blog, Todd Park is telling us that “New Medicare Data Offers Unprecedented Transparency for Consumers”.  Considering that the Medicare physician fee schedule was always public and anyone could see the price of any service in any locale, and considering that the total amount Medicare is paying out to doctors is also a fairly well known number, what is it we didn’t know? Lots of stuff. First, we didn’t have an itemized list of how much Medicare is paying each doctor for each individual service. Now that we do, we can learn, for example, that Dr. X in St. Louis has billed Medicare 200 times for venipuncture (at $3 apiece) for 100 patients and also billed for about 200 office visits for 100 patients. It seems that if you go see this doctor, you will invariably end up with a needle in your arm, so better find someone else who is not going to hurt you just because you showed up, and have all sorts of unnecessary tests done on you. See how helpful data can be to an informed consumer? Don’t worry; you won’t have to engage in such complex analysis for much longer, because journalists and unemployed technologists are busy building 4th grade literacy level tools and decision aids for us all.

But that’s nothing compared to the power of implied impropriety. There are two dollar columns in this unprecedented trove of data, one is what the doctors billed Medicare and the other is what Medicare paid. A while back Medicare released a smaller unprecedented trove of similar data for hospitals with the same two columns. That too was hailed as a new era for informed consumers who will now have the ability to choose hospitals based on the value they provide. Fast forward to today, and all that remains from that particular trove are a bunch of articles highlighting the immoral variations between hospital charge master prices and their effects on the uninsured. Since physicians’ data exhibits the same discrepancy between what is billed and what is paid, and since nobody cares to understand why and how those charges end up on claims, you can expect similar stories about uninsured people being charged “sticker prices”. On a side note though, how come people are uninsured? Isn’t it illegal to be uninsured? Shouldn’t you just head over to Healthcare.gov and get affordable insurance instead of complaining about prices for the uninsured?  Yes, you will end up with a high deductible, but you won’t have to pay sticker price, and I’m sure there will be some in-network facility within driving distance that can treat chest pain, and if there isn’t, maybe as an engaged patient, you should buy one of those iPhone defibrillators Dr. Eric Topol is using on airplanes, or was it an Android EKG, not sure. But I digress.

What else can we do, or are expected to do, with this data treasure? Well, it seems that CMS is asking all of us to grab a magnifying glass and play “Where is Waldo?” with this unprecedented trove of clues for how Medicare is being defrauded by doctors. CMS, it seems, has no ability to systematically flag the Chiropractor who bills upwards of 150 manipulations per patient per year, so it keeps paying and paying ad infinitum. In lieu of building a few cheap algorithms, why not throw the entire database out there and see if taxpayers can obtain some free fraud detection from the public at large? Sort of like the Sheriff used to put together a citizen posse to chase and apprehend criminals in the old west…. The criminals, particularly the ones not guilty of any crime, should adapt and learn how to use Big Data troves to defend themselves, with the added benefit of accelerating “trends toward large medical groups and doctors working as employees instead of in small practices”, per the Huffington Post. That is a good thing too, because dealing with organized crime is so much better for society than dealing with petty theft.

Where does this leave individual physicians? Well, you could run for the nearest rock and crawl under it until this too shall pass. Alternatively, you could start generating some educational content of your own, trying to explain to your patients what the troves of data mean, and what they don’t. You could put together more complete data, at least for your own patients, and address the clinical rationale for those completely out of context data points. You could write for larger audiences, and you could contact your local media offering to provide some balance to the tabloid stories about millionaires injecting people in the eyeballs with Lucentis.

The one thing I would recommend you don’t do, is to seize this opportunity to vent your frustrations with higher paid specialties, because the media is already doing that, and because this is exactly what they want you to do, and because in the eyes of the public there is no difference between this or that specialty. It’s hunting season for all doctors, and you will not save your neck, or your specialty, by joining in the hunt for other species. And finally, considering that the median amount of money doctors were reaping from the program for the elderly and the disabled was around $30,000 per year, I can’t help but wonder if some business decisions are not highly overdue, for some people. Just sayin’… 

Health Care is Like Katz’s Deli

Sometime during the last year of the second millennium, I wrote my last letter in response to the last letter I have ever received. It’s been email ever since. I don’t recall making a conscious decision to stop writing letters. It just happened. I cannot pinpoint the exact date when my work memos, agendas, proposals and various notes, disappeared from my desk as if swallowed whole by my laptop. They just did. I still have lots of papers lying around, but I recently noticed that I don’t have any pens. Now, I will let you in on a little secret. I can’t type. I have written tens of thousands of lines of code, thousands of emails, business plans, presentations, contracts, white papers and blogs, typing with one finger. I like it this way. I use everything Microsoft Office has to offer, but only ten percent of functionality, or maybe even less, and I use it all day long. I don’t know anybody that uses computers the way I do. There are times when I have to interact with proprietary software that I did not choose, to complete tasks I don’t care about, and invariably, no matter how slick that software is, I hate it. Basically, I hate everything other people make me do.

There is a mantra that never fails to materialize whenever EMRs are discussed, which says that EMRs were built for billing, and that’s the reason why so many doctors dislike their EMR. I beg to differ. The template option of documenting a patient encounter was built for billing, but the remaining 90% of the EMR was not. When you first open your EMR, what do you see? A list of today’s schedule? That wasn’t built for billing. A “to do” list? That wasn’t built for billing. When you select a patient record in your EMR, what displays on your screen? A “summary” page for that patient? That wasn’t built for billing. Everything you see on your screen when you prescribe medications, order labs, review results, send a task or a message to staff or patients, generate referrals, change your password, maybe take a blood pressure measurement here or there, was not built for billing. It was not built for billing because you don’t bill for any of those things, so it couldn’t possibly have been built for billing.

But then, most of what doctors do with EMRs is documenting encounters with patients, and when you get ready to do that, invariably the dreaded screen, full of checkboxes and drop down lists, opens up in its unparalleled glory. This was built for billing. Look at that screen a bit closer, and you will discover that everything that was built for billing is actually optional. You could type, with one finger if you wish, three sentences, and be done. In most cases you could dictate five sentences right then and there and be done. The computer is not going to detonate on your desk if you don’t click the “normal” box to load seventeen pages of PERRLA EOMI into the note, and the police are not going to barge through the door if you don’t choose medically necessary ICD-10 and CPT codes. You could document your encounter precisely the same way you documented it twenty years ago, maybe using Dragon instead of a little dictation gizmo, and heck, you could use a pen on a piece of paper and let Mary “attach” it to the visit note later, because the EMR will let you do that too. You got paid before you ever laid eyes on an EMR template, and you will continue to get paid if you never use one. You could use your EMR the same way I use Microsoft Office picking and choosing the ten percent that makes your life easier and ignoring the rest. And your colleague down the hall could choose a different ten percent that makes her happy, and we could all dispense with the drama.

Yeah, well, no, you really can’t do that. Why? Because “other people” are making you do things you don’t want to do, things you don’t care about, and they are using your EMR to enforce their will on you. And if you are anything like me, you will hate that EMR, no matter how much usability and functionality has been baked into it. This probably explains a good chunk of EMR dissenters, but it does not explain everything, because just like most things in life, righteous opinions have more to do with luck and random events than with absolute truths.

First thing to observe is that medicine is, or was until recently, a complex set of personal services. A personal service is a service provided by one human being to another, and as such differs greatly across endless dyads of people engaged in providing and receiving a service, and across the spectrum of services (think hairstyling). When you attempt to mediate a personal service with a canned computer program, you will find that sometimes the software fits in like a glove, and other times it fits in like an elephant in a china store. The rest is just a matter of degrees. Simple probability ensures that there will be doctors for whom a given EMR is perfect, in most cases right out of the box. If luck has it, and they happen to buy, or be given, that one EMR, they will be content. If in addition to lucking out on their EMR choice, their personal style of service happens to match those things that “other people” want them to do now with their EMR, you will have a bunch of very happy campers. And extremely happy campers have a tendency to turn into evangelists.

At the other end, you have the folks who drew the wrong fitting EMR, and whose personal service style is diametrically opposed to the new paradigms, sometimes to the point of completely eliminating EMRs from consideration. This group is where the prophets of doom reside, along with a silent majority keeping their heads down, constantly looking for escape hatches. In between the singers of odes to joy and those contemplating professional suicide, there are hundreds of thousands of physicians with milder feelings about this entire state of affairs, and some are eloquently vocal. The ones I find most intriguing are the producers of bi-polar and often schizophrenic narratives about the grim reality of being turned into “data entry clerks” by mandated use of technology that “is not ready for prime time”, while wholeheartedly supporting the speedy transformation of medicine into a Big Data business, which is the multifactorial silver bullet for all that ails humanity.

And this magic silver bullet is blocked from firing because of the second EMR mantra which states that EMRs “can’t talk to each other”. Presumably once EMRs begin talking to each other, physicians would be free to enjoy the wisdom of Big Data without the inconvenience of generating it. Sort of like having your cake and eating it too. Alas, Big Data’s elements are the building blocks of EMR linguistics and are a prerequisite to having EMRs talk to each other. Thus the agony of collecting mountains of structured data elements for payment purposes is being replaced now with the misery of collecting troves of structured data elements, which include, but are not limited to, what is required for billing. One would think that we could slow down and let technology evolve at its normal pace, and let doctors pick and choose how much EMR they want to have for breakfast, but we really can’t do that anymore, because we no longer control the process. Big Data business does.

I just looked up from my keyboard and saw my son watching a TV program where folks seemed to be searching for the best sandwiches in America. They were at Katz’s Delicatessen in New York. Katz’s Deli is a family business, established in 1888 and passed down through several generations. They make and serve pastrami exactly like they did in 1888. They even slice the meat with a knife instead of the latest slicing machine and insist that it’s better that way. Katz’s Deli, and the handful of other establishments like it, managed to survive the mass destruction of the mom & pop sandwich business by the mass creativity of Subway. Maybe they were lucky and maybe they were also a bit smarter. Every owner of every shop on that TV show was wearing an apron, serving customers and addressing them by their first names. Every owner, and every interviewed customer, said that deli meats are really about long term relationships and pride in handmade personal service.

During WWII Katz’s Deli began a tradition of sending salami to the boys in the army. Today, Katz’s Deli will “Send a Salami to Your Boy in the Army” straight from your computer screen, because Katz’s Deli has a website and you can shop online for some things. I am certain they have computerized cash registers too, but they insist on marinating, spicing and smoking and slicing every bit of pastrami by hand, right there on Houston Street. See, Katz’s Deli uses computers like I do. They take the ten percent that seems useful, the ten percent that doesn’t alter the essence of their art, and never bother with the rest. And business is booming, because Katz’s Deli discovered the only way to survive Schumpeter’s gale (which by the way describes how capitalism dies by marching from crisis to crisis in a doomed quest for more thorough exploitation of the masses), and beat back the armies of creative destructionists with a stick. You have to be really good at what you do, and you have to want to be the best at what you do, and you have to carefully add a dash of good technology to bring your personal flavor out.

I’m going to surprise my boy now and order some handmade pastrami… Ess gesunt!

Is the Nuremberg Code Obsolete?

Long ago and far away, at the conclusion of a worldwide armed conflict, the winning side was shaken to its moral core by the discovery that massive and cruel medical experimentation has been routinely conducted on human beings.  The perpetrators were brought to trial and the verdict included not just punishment for the guilty, but also a message for posterity intended to prevent future atrocities. It was a code of ethics, very brief and written in plain language, and it was named after the city where the trials were held. The Nuremberg Code eventually became the basis for U.S. federal laws governing research on human subjects and known today as the Common Rule. The first article of the Nuremberg Code is about consent:

“The voluntary consent of the human subject is absolutely essential. 

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.”

Some 67 years later, a generation of medical researchers with no first hand memories of either Nuremberg or what preceded it, are finding the absolute nature of this ethics code to be a hindrance in their morally superior efforts to save the world from health care system inefficiencies. In this day and age of readily and abundantly available electronic data, the antiquated processes of obtaining proper consent from experimental subjects one by one, for simple things like comparative effectiveness research (CER) or quality improvements (QI), are slowing down the computerized trains of progress. After all, we are not talking about hacking people with machetes or purposely infecting them with horrible diseases or any of the nightmarish scenarios that brought about the terror embedded in the Nuremberg Code. We are talking about a clearly beneficent learning system, made possible by health information technology, where every patient is a research subject and every doctor is a research assistant, and we all cheerfully share and cooperate to advance our collective medical knowledge and to make health care better and cheaper. The inconsequential details can be safely left to our betters, who are now, always will be, and in America always have been, on the side of angels.

Following the controversy surrounding the National Institutes of Health (NIH) funded SUPPORT trial, which tested the effects of different oxygen saturation targets for premature infants (within acceptable “standard of care” limits), the Office for Human Research Protections (OHRP) held a public hearing in August 2013 regarding the nature of informed consent for randomized clinical trials. Leaving the SUPPORT controversy aside, two very distinct opinions regarding consent emerge from reading the various testimonies before the committee. The traditional opinion argues that there is a difference between treatment and research and that informed consent is required for both, including study of “standard care” interventions, CER and QI; that randomization always deprives research subjects of the judgment of their physician and that these issues are governed by law (e.g. the Constitution and such). The progressive view, presented by testimony from members of the Institute of Medicine (IOM), its Clinical Effectiveness Research Innovation Collaborative (CERIC), NIH and other research establishments, posits that randomization of “standard care” interventions poses no additional risks to patients, since doctors’ decisions are essentially like flipping a coin anyway, and therefore patients in this new learning system may be subjected to randomized CER and QI experiments without explicit consent and with minimal, if any, information (e.g. “something posted on the door”).

The notion of a Learning Health Care System has been introduced by IOM, and it forms the basis of the Federal Health IT Strategic Plan published and maintained by the Office of the National Coordinator for Health Information Technology (ONC). ONC describes the vision of a learning system to be “an environment where a vast array of health care data can be appropriately aggregated and analyzed, turning data into knowledge that can be put to immediate use”. The immediate concern with this utopian structure is of course privacy of the observed, and the basic individual right to not be observed. However, as the IOM/ONC thought process evolves, and as evident from the OHRP hearing and subsequent articles recently published by IOM and research industry affiliated individuals (here and here), the learning system is not only assuming that patients should be observed without explicit consent, but that they should also be subjected to randomized experimentation without explicit consent, if the designers of experiments classify their activities as CER or QI, all within the boundaries of “standard care”.

Furthermore, a Hastings Center Report, briefly mentioned in the OHRP hearing, introduces the idea that all patients have a “duty” to subject themselves (and their children) to health system “learning activities”, which include randomized experiments, with or without informed consent, depending on the nature of the experiment, the level of difficulty in obtaining consent and the judgment of the health system. The duty of course is to contribute to the common good. The implicit assumption being made here is that “The System” is experimenting on people solely for the common good as well, and that we can trust the beneficence of “The System” in perpetuity, or until we discover otherwise. This line of thought is indeed congruent with the modern trend to manage the health of populations, which is quickly replacing the old fashioned view of medicine as a personal service, where the locus of trust was the individual physician and the overriding interest was the individual patient.

So how do we get from here to there? The old HIPAA law grants permission to health care facilities to use and disclose health care information for the purpose of treatment, payment, and health care operations, and patients must sign HIPAA consent forms prior to obtaining any type of treatment (exclusive of true emergencies where consent is implied). If we “broaden” the meaning of health care operations, which is already broad enough to drive a truck through, to include “learning activities”, and if we define “learning activities” to include randomized clinical research on human subjects that poses only incremental risk to patients, compared to doctors flipping coins, then we have the ability to monitor, collect and analyze any and all data on every single patient. To complete the task, the Secretary of Health and Human Services (HHS) will need to provide additional regulatory “guidance” on how the Common Rule can be ever so slightly relaxed to exclude certain “learning activities”, and hence the OHRP hearings (OHRP is part of HHS).

I do understand that this is a complex subject and opinions may differ, so a vigorous debate is healthy. But this debate cannot take place in obscure OHRP hearing rooms, or on the pages of the New England Journal of Medicine, or even in multi-stakeholder IOM round table meetings. With all due respect to distinguished researchers, bioethicists and political appointees, this subject is above and beyond the pay grade of all currently involved in it. This debate is not about paperwork or IRB management techniques. This debate is about diminishing those humanitarian protections that inconvenience the electronic age of Big Data and little people, and no amount of patient-centered terminology (or David Hume quotes), will change that. This debate should take place on the front page of the New York Times, the Wall Street Journal, CNN, MSNBC, Fox News, and the floors of Congress, and eventually in front of the Supreme Court. This debate is ours to settle. Vox populi, vox Dei.

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