Tuesday, April 22, 2014

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….

Thursday, April 10, 2014

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’… 

Wednesday, March 26, 2014

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!

Tuesday, March 18, 2014

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.

Wednesday, March 5, 2014

Post Removed by Author

This blog post has been removed.

My sincere apologies for the inconvenience.

Monday, February 17, 2014

What the Heck is mHealth?

Wanted: White knight (shiny amour optional) to save us from ourselves and the wretched lifestyles we choose.

Your coffeemaker went dead on you this morning, and while lamenting your drowsiness at work, your friend Denise mentions that she just bought a new coffeemaker at Target and she absolutely loves it. You take your coffee the same way Denise does, black, strong, and all day long, so you decide to buy one for yourself. You are a busy professional and you don’t have time to go to Target, search for a good parking spot, walk to the store, walk around until you find the small appliances, pick it up, stand in line, walk back to the car, struggle to back out from the too narrow parking space, and drive home through congested intersections. It could easily take half an hour out of your already busy day. So you decide to buy it online in the evening. You get home, feed the kids, answer a couple of urgent emails from your boss, and after everybody goes to bed, you settle down to finish those spreadsheets you meant to complete at your office, but ran out of time. In between emails and spreadsheets, you remember your coffeemaker, browse to Amazon.com, search for it, find it, and are getting ready to order when you notice that the ratings are not stellar. It seems that 347 shoppers, just like you, gave it only 3 stars. Surely you can do better than that. So you search for coffeemakers in general, find a whole bunch, sift through ratings after ratings, and learn that people that bought a coffeemaker also bought filters and funny little measuring spoons. An hour later, you settle on some other coffeemaker, throw in a gold filter that never needs replacing, some organic rainforest coffee, and a box of genuine Italian biscotti that the raters say go great with your green coffee, and order the whole bunch from Amazon, which gives you free two days shipping with one click of a button. You feel very efficient and very accomplished. You just spent twice as much time as shopping at Target would have taken, sitting on your chair in the comfort of your home, spent twice as much as you intended, and for the next three months or so, every time you open a browser, some well-meaning retailer will be providing you advice on what else you need to buy to make your coffeemaker happy. You have proven that you are a good and savvy consumer, and now you can advance to the next level, and try your hand at consuming health care.

The first order of business is to place health care at your fingertips so you can shop for it while sitting motionless on a chair, in the comfort of your home. Going to an actual doctor is as inconvenient and as detrimental to your worker productivity as going to an actual store, and probably much worse, because once you enter the doctor’s office, you are denied the freedom of choice that comes from being able to compare ratings and opinions of other savvy shoppers like you, and barred from accessing the benevolent advice freely available on websites. Health care shopping is the ultimate level in this game, so it requires new tools, collectively known as mHealth, or mobile health. Mobile, not because God forbid you may have to move to use them, but because these sophisticated tools do all the moving for you, much better than the old fashioned Amazon.com ever did. mHealth can attach itself to your pocket, your clothes, your wrist, your underwear, your skin, your eyes, and can even nestle comfortably inside your body. mHealth does not need you to summon it into existence like Amazon.com did. mHealth is always there, tirelessly working on your behalf, anticipating every muscle twitch, every thought and every desire you may have, providing you with healthy advice and support in your times of need, even in your sleep. Like a good butler of days gone by, mHealth makes it its business to quietly learn everything there is to know about you, so it can provide you with a level of personalized service, once only available to fabulously wealthy individuals, and now available for free to every convenience seeking pauper.

As of February 10, 2014, the Apple iStore contains 29,504 health & fitness apps, and 23,420 medical apps. Together, these apps are known as mHealth. Most are free, some cost a few cents and some have substantial pricing. Most are standalone, simple things, and a few are part of larger elaborate systems of smart hardware, some wearable, others to be used at certain times only. They range in scope from expert advice on where to buy pesticide free eggplant to FDA approved medical devices for measuring the function of your heart. There is only one thing all mHealth apps have in common: they all collect information about you. Collectively, mHealth knows when you are sleeping and knows when you’re awake. It knows what you are eating, when you eat it, and where you are while you eat it. It knows if you are walking or running or just sitting down. It knows your vital signs, your mood, your diagnosed ailments and all the medications you are taking. It knows who your friends are, what they look like and sometimes what they are eating too. It knows more about you than your spouse, your mother or your children. And since mHealth is a social animal, it is happy to share all that knowledge with the world, so the world can better cater to your specific needs. And the world is eager to reciprocate and share everything it knows about you with your mHealth. From Amazon.com to Target, the IRS, the DMV, MasterCard, the Department of Homeland Security, your alma mater and even your own car, everybody will be joining forces to serve your health in more and better ways.

There is one small problem though, and that’s your secretive relationship with your doctor. For some reason, doctors insist on talking to you alone, behind closed doors, like criminals. They say things, you say things, maybe you all look at things, and nothing gets transmitted to your mHealth. The world and mHealth can’t really help you if you keep secrets from them. The government, acting on behalf of the world at large, is now installing computers in doctors’ offices and mandating disclosure of your secretive conversations. That’s a good first step, but the ill-fitting EHR technology is still unable to communicate with the world, let alone your mHealth. To speed things up a little, the government is paying doctors to make you manually transmit your previously secret information to your mHealth. With one click of a blue button, you can liberate decades of your most private secrets, and send them to roam free through all the mHealth apps out there and combine themselves in most fortuitous ways with data from Amazon, Target, Verizon and all other agents toiling on your behalf.

And if you think this is some sort of utopian wishful thinking, I suggest you read the recent issue brief from the Office of the National Coordinator for Health Information Technology (ONC), about the government’s plans on “Using Health IT to Put the Person at the Center of Their Health and Care by 2020”. It’s only eight pages long, with large fonts and soaring rhetoric that mentions the word physician only once and makes no reference to doctors, because this is all about you, the person and future patient. By 2020, the ONC envisions that “The power of each individual is developed and unleashed to be active in managing their health and partnering in their health care, enabled by information and technology.” You get goosebumps just thinking about the tens of thousands of elderly folks with heart disease, cancer, and dementia, suffering in silence and yearning since the Second World War to have their powers developed and unleashed.

This wonderfully clear ONC manifesto, lays out a roadmap to a “brighter, more inclusive future”, enabled by the “emergence of health IT, including consumer eHealth tools” (a.k.a. mHealth).
  • A future where: “Individual self-determination and the public good are both optimized”
  • A future where we: “Motivate policymakers, employers, and other stakeholders to establish guidelines and environments that promote and support healthy behavior”
  • A future where we: “Soften or erase the boundaries between what occurs inside and outside of the health care system by promoting increased information flow”
  • A future where we: “Encourage providers to value patients and their data”
  • A future where we: “Build appreciation for and competence in technology-enabled self- and shared management of health and health care, by both providers and individuals”
  • A future where we: “Encourage interaction in online communities via social media”
  • A future where we: “Facilitate the aggregation of health and health care information for individuals and populations from diverse sources, including non-clinical information if desired”
  • A future where we: “Promote technology that shows trends in diverse health status measures, including deviations from normal for the given individual”
  • A future where we: “Promote easy-to-use technologies that integrate individuals’ health activities and treatment into the rest of their lives, where and how they already live, work, and play”
This is just a happy roadmap and ONC is not certain if “consumers and providers will fully embrace the resulting cultural shift”, but they are “optimistic that stakeholders will rise to these challenges”. I am too, and Mr. Kurt Vonnegut was already optimistic back in the middle of the previous century. Unfortunately, Mr. Vonnegut died before his power could be developed and unleashed, and thus was spared the joy of watching the stakeholders rise with the shifting cultures, but wherever you are Kurt, here is a rainforest coffee toast to your prescience. Amen.

Thursday, February 6, 2014

10 Misfortunes We Shouldn’t Blame Obamacare For

There is a new report out from the Congressional Budget Office (CBO) titled “The Slow Recovery of the Labor Market”, and as its title implies, it predicts a slow recovery from a labor perspective. Among other things, the CBO report is now making headlines in the political game of Obamacare because it forecasts a 2.5 million job reduction by 2024 due to the effects of the health care law. You should read the report itself (it’s not very long and it has lots of pictures), because it is practically impossible to find objective coverage of its contents in today’s media, which is full of ideology driven experts and completely devoid of old school reporters. I don’t know about you, but I for one am growing tired of the incessant drumroll crediting or blaming Obamacare for everything from the price of gas at the pump to the demise of penguins in Argentina, so let’s show some magnanimity and absolve Obamacare from, at least, the following 10 naturally occurring phenomena.

Number 10: The CBO labor forecasts – Starting with the most recent development, we should observe that the CBO report is not stating that Obamacare will create a shortage of jobs or increase unemployment, which will remain high independent of Obamacare. These 2.5 million jobs are projected to be voluntarily forgone by people, or as the White House press secretary put it, “Americans would no longer be trapped in a job just to provide coverage for their families, and would have the opportunity to pursue their dreams”.  And for 2.5 million able bodied folks, those dreams are projected by the CBO to include no work. Instead of having to toil from dawn to dusk in large offices or start small businesses of their own, Americans now have a choice, and we should rejoice in utter disbelief that in a country where one in five children is living in poverty and unemployment is rampant, citizens finally have the liberty to earn no income.

Number 9: Health insurance cancellations – Much ado about nothing was made of millions of insurance cancellations sent in bulk to those who purchased health insurance on the individual market. In case you weren’t aware of it, this type of mass turnover has been occurring in this hapless segment of the market since the beginning of time. Every year, all insurance companies rescinded all policies for all their customers. If your experience is different, then you are definitely an outlier. Besides, it is a well-known fact that individual market policies, as opposed to those issued by benevolent employers, such as Walmart or McDonald's, were pure garbage before Obamacare, as any retired executive, or middle class family can tell you.

Number 8: Health insurance premium hikes – Seriously? We wouldn’t be having Obamacare if insurance premiums wouldn’t have crippled our economy, impoverished the nation and rendered Apple and Google incapable of competing in the global markets. It is true that Obamacare is forcing insurers to pay out a fixed share of revenues to doctors and hospitals, but Obamacare is also delivering millions of fully subsidized customers to private insurers, allowing revenues to grow through volume in addition to the customary growth in unit margin. This should help avoid wanton increases in premiums beyond originally projected ones.

Number 7: Price of Care – Yes, prices for medical services are exceedingly high in the U.S., but Obamacare was obviously not the catalyst for those. The hospitals started this trend many years ago, and private insurers who like any honest enterprise, get to keep a percent of their revenues, had little incentive to curb the hospitals’ enthusiasm. It is true that Obamacare is providing incentives to hospitals to consolidate into price gauging monopolies, but aren’t monopolies the natural outcome of a free market? The cost of health care in the U.S. was almost double its nearest European competitor before Obamacare, and it still is, and Obamacare had absolutely no ill effects, or any other effects, on that sad statistic.

Number 6: Narrow networks – It seems that people signing up for new Obamacare plans are having trouble getting to see their old doctors, because health insurance companies have concluded (based on extensive and nonexistent research) that folks prefer cheap insurance over actual medical care. Thus, all consumer centered benefit designs include less doctors, less hospitals (particularly popular ones), less of what consumers don’t need or want, and more insurance stuff, such as peace of mind. This cost containment strategy has been initiated long before Obamacare was even contemplated (remember the nineties?), and it worked exceedingly well when combined with #8 above. All Obamacare did, was to create the healthy transparency needed for us to observe this highly beneficial trend towards value for our most esteemed citizens, such as AARP and United Healthcare.

Number 5: Shortage of doctors – Ah, the scare tactics of the rabid right are at work again. Supposedly, Obamacare and its millions of uninsured will be flooding doctors and hospitals, squeezing paying customers out of their place in line. Nothing could be farther from the truth. First, as any Obamacare advocate can tell you, we’ve been having a shortage of doctors long before Obamacare kicked in a month ago, so this has nothing to do with the health care law. Second, Obamacare contains many provisions aimed at finding ways to liberate doctors from the practice of medicine, and to liberate medicine from practicing physicians, so consumers can avail themselves of health care uninhibited by ancient guilds. Also, when insurance plans are firing doctors from their networks by the thousands (see #6 above), how can any free-marketer in his right mind suggest that there is a shortage of doctors?

Number 4: The insurance gap – This is the bleak spectrum of folks who are not poor enough, old enough, young enough, or otherwise demographically endowed enough, to enjoy the opportunity of pursuing their dreams of not working while having the peace of mind that comes with an insurance card. Obamacare tried its hardest to liberate these folks, but a conservative Supreme Court and recalcitrant Governors in red States have come together to obstruct the expanded Obamacare subsidies in many States. It looks like the Governors are beginning to soften their stance though, so we should see more Medicaid cards issued soon. Either way, Obamacare did not cause folks to be in this category to start with, and if you must blame someone, blame the Governor or the judicial branch of government.

Number 3: The Website – We’re talking about a website, a minor technical detail that has absolutely nothing to do with the essence of Obamacare. Yes, Healthcare.gov and several other local health insurance exchanges have been a good example of how not to build and deploy software. It was a learning experience for the nation, and there is clear value in that. As any entrepreneur can recite in his sleep, failing early and failing often is the only way to achieve success. And the website seems to have accomplished that, at the modest cost of less than half of what it would cost to build, say, a new Space Shuttle.

Number 2: Redistribution of wealth – Yes, Obamacare is providing subsidized insurance to the poor, and yes, Obamacare is forcing the young and healthy to pay more so that the old and sick can be charged less, and if you look at the chart published by the Brookings Institute, your heart will sing with joy at the sight of two huge positive columns of gains for the very poor, and the tiny loss columns for everybody else. Until you read the full report, that is. Those huge income gains for the poor, you see, include the money paid by the government on their behalf to insurance companies, and as Brookings wisely shifts the terminology, these are gains in “well-being”, not cash in your pocket. We could use similar logic to divvy up what the government pays defense contractors, agribusinesses, all foreign aid, government salaries, and pretty much the entire federal budget, and show a vast increase in “well-being” for the poor. The President’s recent lukewarm inequality rhetoric notwithstanding, rest assured that Obamacare is not even remotely trying to alter the Darwinian redistribution of wealth in use today.

Number 1: Dysfunctional government – Obamacare, although the most hotly debated federal undertaking in recent memory, cannot be blamed for the present impotence of our federal government, no matter what they tell you from the right or left side of the aisle, or the TV.  If President Truman were alive today, he could write volumes on his own “Do Nothing” Congress. Obamacare is actually the one rare incident where a significant law has been passed in the five years following the election of President Obama. It is testimony that Congress can indeed legislate, and it is proof that our government is working as redesigned by an invisible hand. Sure, Obamacare has been the favorite football for the biggest exhibition game on earth right now, but you don’t usually blame the football if your team just doesn’t show up in New Jersey.