Thursday, March 29, 2012

The People’s Advocate at the Supreme Court Bar

H. Bartow Farr, III, Esq.
The Patient Protection and Affordable Care Act (PPACA) has finally met its challengers in the highest Court in the land and following the three days showdown, there’s nothing left but watchful waiting for the Supreme Court to hand down its final decision. All media outlets from left, right and supposedly middle are covering the events and hundreds of experts are ready to make predictions based on the inflections in one Justice’s voice. I made a point to not read any of that, and if you are an informed citizen who still insists on making his/her own mind, the very impartial SCOTUS blog is the place to go for links to the audio and transcripts of all oral arguments and all briefs submitted to the Court. By this logic you should probably not read what follows below either, but if you do, this is an unorthodox (neither left nor right) look at the proceedings from a citizen's point of view, a perspective that struck me as lacking in the proceedings themselves.

The main contenders were the Republican Governments of 26 States against a Federal Government controlled by a Democratic administration. There were also some private plaintiffs with a strong Libertarian argument, but their contribution to the subject is not clear to me, and is probably just a largely inconsequential sideshow. Generally speaking local governments were wrestling with central government in an outdated Federalist argument, where the people themselves have no standing.

The main event took place on Tuesday, March 27, where the constitutionality of the individual mandate, requiring every American to buy health insurance or pay a penalty, was argued, with the Federal Government arguing that its power to regulate interstate commerce includes the right to mandate that everybody buys health insurance, and if not, then the penalty should be viewed as a tax. The State Governments argued as expected that this gives the Feds unlimited power and a penalty is not a tax. The lively debate came complete with broccoli, burial insurance and babies being denied care at the hospital, hypotheticals. But here is what I found interesting: at the heart of the Federal Government argument was the contention that the uninsured are basically offloading their health care costs on the insured and society in general, therefore we must mandate that they buy insurance and pay their fair share. The States on the other hand, argued that forcing healthy people who don’t want to buy insurance to subsidize the sick is really not fair. Most Americans, as everybody agreed, are already purchasing health insurance, so who are these freeloading uninsured?

Well, it seems that 68% of the uninsured are under 140% of the Federal Poverty Level (FPL), and 95% of them are below 400% FPL. A full 45% of poor adults and 17% of poor children (under 100% FPL) are uninsured. Are these our freeloaders? Are these our interstate frequent travelers who impose huge uncompensated expenses on States where they don’t live? Are these poor people without insurance seeking out States that enacted guaranteed-issue and community rating insurance laws and move there en-masse? Is anybody else doing that? Do we even know what problem we are trying to solve?

Another pearl from the March 27 arguments was the realization that the States concede that the Federal Government has the power to require that people pay for health care with insurance. They only differ on the timing of buying the necessary insurance instrument, with the State Governments insisting that a free citizenry should have the right to purchase insurance en route to the ER, if they so choose, and the Feds arguing that they must buy insurance the day they are born. Does that mean that one cannot pay for health care with cash, or chickens? Will they check to see if you have insurance and if so, cash payments will be disallowed? What do you do if you’re one of the penalized? Do you get to pay cash, or do you get some services in return for all those penalties you paid into the system?

As interesting as the constitutionality arguments were, I found the session on severability to be most enlightening. On Wednesday, March 28, the Court grappled with the next steps, if the individual mandate is by any chance found to be an unprecedented and unlimited expansion of Congress powers and thus ruled unconstitutional. The 26 Republican governed States argued that the Court should throw out the entire Obamacare legislation with the mandate, because everything else in the PPACA is either hinging on the offending mandate or is unimportant. This is not surprising, since the war on the individual mandate, which is the brainchild of an ultraconservative foundation, is just a battle in a much larger war to remove the current Democratic President from office. The Federal Government began its arguments by mentioning the millions of citizens that are not standing before the Court and how the Court should nevertheless give them consideration. That was beautiful, but it didn’t last long, because eventually it became clear that the Federal Government is asking the Court to strike down both guaranteed-issue and community rating clauses along with the individual mandate, if found unconstitutional.

The Federal Government, true to form, was arguing on behalf of its insurance companies patrons. Unless the Feds can guarantee a certain number of customers, there is no way that insurers will agree to sell their wares in a non-discriminatory manner, because discrimination is how insurers make money, and no government should infringe upon basic rights of corporations. It fell to an attorney independently appointed by the Supreme Court to argue for the people, and (very eloquently) make the simple point that the purpose of the PPACA was not to provide customers to insurers, but to make health care affordable to all Americans, including poor and sick ones. The individual mandate is just one tool in an arsenal of tools to accomplish that end. It may be a very useful tool, but it’s not the only tool, and therefore if it is found unacceptable, it should be severed from the legislation and removed without throwing out the baby with the bathwater.

So the People finally got their 15 minutes in Court, represented by Court appointed counsel, as paupers usually are. Whatever the Court decides in this case, I will forever be grateful to the Supreme Court of the United States, the nine unelected Justices, who saw fit to solicit someone to speak for the People, something that neither States nor Federal Governments seemed to be too terribly inclined to do. And I am grateful that the Court chose H. Bartow Farr, III, Esq. to represent us in this matter, since his oral arguments were second to none, and may God grant the Court the wisdom to do what Mr. Farr advocated that they do, and the People shall prevail.

Sunday, March 25, 2012

I Don’t Want To Be Digitized

I live in a bubble where everybody seems to be obsessed with Health Information Technology (HIT). The average man or woman you meet on any American street has no idea and no concern about the insurmountable difficulties associated with Electronic Health Records (EHR) and other HIT initiatives. I know because I asked random folks I encounter at the gas station, the dry cleaners, the supermarket, Starbucks, the grocery store and other mundane locations. It’s not a scientific survey, but it is disconcerting for me to realize that my days are consumed by something nobody cares about. I’d like to think that, although obscure, my endeavor could somehow better the condition of human kind, at least the portion of human kind that I can touch. To that end I come up with visions of a future where HIT enables millions of people to receive state of the art, truly personalized health care in thousands of small intimate locations filled with expertise and compassion, where everybody knows your name, and the computer knows your genome. Other folks in my bubble, probably for the same reason, are conjuring futuristic images of implantable sensors and long distance care delivered by artificial intelligence, with the occasional, and mostly preventable, acute episode addressed by robotic devices, supported by super computers in an operating room of the future.

Steve Jobs was an implementer. Gene Roddenberry was a visionary. There isn’t much technology out there today that was not envisioned by Mr. Roddenberry in his sci-fi odyssey through the infinite universe, and the most forward thinking idea tossed around now is Gene Roddenberry’s half century old notion of a tricorder, a hand held device that can evaluate health and diagnose disease in noninvasive ways. The Star Trek ethos presumes the existence of EHRs and HIT, just like it presumes the availability of all information ever recorded (Big Data?) in the all-powerful computer that speaks with Mrs. Roddenberry’s voice. We have a long way to go before the technology vision is fulfilled, but we have an even longer trek ahead of us before Earth becomes the hunger free, poverty free, greed free, egalitarian planetary bliss, where Mr. Roddenberry envisioned his technology to be operating for the common good.

The other day I was watching a recording of Dr. Eric Topol speaking to a group of Google engineers. The charismatic and super credentialed Dr. Topol has a new book out, and a vision of digitizing human beings in order to prevent and cure disease. Humanity has been engaged in a quest to prevent and cure disease since the dawn of civilization, and probably long before that. While the means to that end have steadily advanced from a patriarch blessing, to magic bracelets, secret potions and finally to chemicals and HIT, the goal remains the same: we don’t want to suffer and we don’t want to die, unless we choose to do so for a higher cause. While the word of God was usually identified as that higher cause, individual Liberty is the modern day call to arms, considered to be worth both suffering and death, but this too may change, because what is now mockingly referred to as “rugged individualism” is quickly giving way to consumers neatly aggregated in analytic hives of predictive similarity.

In the course of his Google presentation, Dr. Topol displayed a variety of cool technologies coming closer and closer to Gene Roddenberry’s tricorder, some that are already available to use and others still lurking in research labs. My fellow residents of the HIT bubble have probably heard of most of these iPhone enabled little miracles allowing one to turn his mobile phone into an ambulatory Intensive Care Unit to constantly monitor vital signs, activity, sleep patterns, items ingested and items excreted. Still in the making are widgets that can monitor your brain waves, your thoughts and other implantables capable of predicting disease before it actually manifests. A broad new horizon is opening up for Ari, an old friend of mine, who is a diagnosed hypochondriac, and until now was costing the socialized health care system in his country tens of thousands of dollars every year for EKGs alone, sometimes in the ER, and most of the time in an endless string of cardiology appointments.

In order for these things to be useful to more folks than just my old friend, they must be somehow tethered to a central command center, where the data is continuously analyzed and either the malfunctioning unit is warned of impending disaster, or better yet, actions are triggered to address the malfunction and restore the unit to normal operating parameters, based on individualized genomic data, other environmental and historical factors, and similar data points from millions of other humans. Obviously, engaging in such complex research and analytics requires that all monitoring data of all people is aggregated and considered by as many intellects as possible, which would be all of us in a sweeping wave of democratization of science placing the infallible wisdom of the collective above the fallible wisdom of any one individual. This is above and beyond Roddenberry’s wildest dreams. Or is it?

I’m afraid (truly afraid) that the glory must once again go to Gene Roddenberry and his crew. Although it took them a bit longer than the tricorder, they composed a detailed picture of a future where humanoids are outfitted with monitoring devices from birth and where crowdsourcing is the prevailing mechanism for collective governance and operations. They named those fictional people The Borg.

Monday, March 19, 2012

Where is Health Care’s Big Data?

The world of health care is abuzz with heated discussions about health information exchange, data liberation and the beneficial consequences of these actions to all stakeholders who use, deliver, regulate or profit from the one fifth of the U.S. economy devoted to medical care. While the efforts to liquefy health information from its solid paper state to a fluid stream of zeros and ones are hardly new, the release of the Meaningful Use Stage 2 proposed rules, has triggered a renewed Pavlovian response to the prospect of having people’s health information flowing freely over the Internet creating massive amounts of Big Data. Before the frenzy gets way ahead of itself, perhaps we should take a closer look at how health information is created, where it resides, how it is shared and what Meaningful Use Stage 2 is targeting for change. In short, let’s follow the Data…

Health Care Data Creation
Health information about an individual begins accumulating from the moment of birth, which is duly recorded when a tiny new consumer emerges into the world. Over one’s life, encounters with the medical system are carefully recorded and now, most of those encounters will be computerized. The following are the main sources of health data:
  • Medical Care Providers – Hospitals, physicians, pharmacists, nurses, therapists and eventually long term care facilities are recording medical encounter information both for treatment and for financial purposes. The data created by health care providers is very rich in clinical information and also contains a significant amount of socio-economic details. Currently, medical information is scattered amongst all providers of health care encountered during a lifetime, and is mostly maintained on paper. Portions of it may or may not be exchanged in an ad-hoc fashion when people seek care at various medical facilities.
  • Public and Private Payers – For the overwhelming majority of Americans who utilize insurance instruments to finance medical care, a lower fidelity version of health information is being maintained by the payer, mostly in electronic format, tallying ailments, therapies and everything else that has a dollar value associated with it.
  • Ancillary Providers – From pharmacies to laboratories and imaging facilities, ancillary service providers are also maintaining lists of medical services and products provided to people and when pertinent, clinical results and invoicing information. This information is also largely maintained in electronic format.
  • Personal Health – Although largely confined to a tiny minority of healthy, educated and tech savvy people, the results of personal monitoring of health indicators are beginning to accumulate in various private information systems. Currently most of this data is created by individuals outside the traditional medical system and is maintained and controlled by new and rather small technology vendors in electronic format.
Health Care Data Whereabouts
Obviously entities that create health data are also maintaining complete copies of said data for their records. However, large amounts of data are being exchanged currently between facilities of care, payers, diagnostic companies and government agencies, mostly in electronic format. As data moves around, and it does move, new repositories of data also emerge.
  • Health Data Creators – Medical care providers, ancillary services providers and payers of all stripes store, maintain and supposedly own practically all health data created by their various business units and all copies of data created by others and transmitted to them during the course of business. There are significant overlaps between various data creators. For example, while payers do create financial data, all clinical information they possess is created and also stored by others.
  • Public Health Agencies – Registries (e.g. immunizations, cancer, etc.) and other regulatory reporting repositories are also storing pieces of information transmitted to them by health data creators as required by State laws and vary greatly in availability and capabilities, but most information is electronically maintained.
  • Clearinghouses – The facilitators of information exchange, mostly medical claims and payment data, medications, and to a lesser extent laboratory data, are also accumulating copies of whatever information is flowing through their systems in electronic format.
  • Health Information Organizations – A special case of the clearinghouse model, these entities are mostly concerned with facilitating communications among regional health care providers, and in some cases are also undertaking data analysis services on behalf of their clients. As such, these organizations in many instances accumulate some portions of medical records data for some segments of the population in their geographical catchment areas.
  • Technology Vendors – Those who supply electronic means to health data creators, and particularly the vendors who offer their technology in a remote service model, retain full access to their customers data, and for smaller customers, such as physicians in private practice, technology vendors are contractually reserving rights to make use of health data in a manner consistent with HIPAA regulations.
  • Consumers – Aside from the emerging personal health monitoring devices and applications, a small minority of savvy consumers is also maintaining personal health records separately from their medical services providers, usually in remotely stored and web accessible repositories.
Meaningful Health Information Exchange
While Meaningful Use Stage 1 did not introduce any tangible breakthroughs in health information exchange beyond what was already occurring, the proposed Stage 2 measures are attempting to spur exchange of health data in several ways.
  • Increase of exiting exchange – All thresholds for information exchange already in place, such as prescription data and laboratory results data, have been increased.
  • Public Health Reporting – Actual reporting of data to government agencies is now required.
  • Provider-to-provider – Some ad-hoc, point-to-point, standardized exchange of clinical summaries between various health care providers will be required.
  • Provider-to/from-patient – In addition to requiring that physicians and hospitals provide health information to patients in electronic format, Meaningful Use Stage 2 places requirements on patients to contact their doctors by email and to access their electronic medical records online. The proposed rules stop short of mandating that patients actually copy their medical records themselves, or ship a copy to a third party recipient, but we have Stage 3 and onwards to look forward to. Either way, technology must be enabled to allow patients, or authorized entities (family, friends, other software, etc.) to extract copies of health information from the HIPAA covered entities where the data was created.
So where is the Big Data of health care? It is very likely that Meaningful Use Stage 2, along with accelerated Electronic Health Records adoption, will increase the size and number of current health data repositories, as well as the ad-hoc exchange of information between them. Changes in reimbursement models will also spur the slicing and dicing of health data, particularly for the purpose of risk management, but there is nothing in the proposed Meaningful Use Stage 2 rules to suggest wholesale merging of health data repositories, and on their own, none of them could be considered Big Data. What if we endeavor to index the contents of all repositories, per the PCAST model, and allow government, or other legitimate “stakeholders”, access to query every indexed and networked health data repository in the land? Is this the much touted and feverishly anticipated Big Data of health care? Meh… Something is still missing.

Big Data is not just lots and lots of data. Big Data is indeed big, but it is also very difficult to accommodate in traditional relational database systems. Big Data is very dynamic and changes fast, furiously and continuously, and Big Data is usually a combination of multiple unrelated sources; it is messy, inaccurate and needs lots of cleaning, processing and culling before it can be used. Well, we all know health care data is a royal mess, but other than that it has no other characteristics of Big Data. Some forward thinking clinical researchers, concerned with the ability of “decision makers” to make decisions for us, are suggesting that we make the data bigger by adding patient reported “psychosocial issues and health behavior”, which are usually outside the realm of medical care. They boldly envision doctors administering questionnaires to their patients to enrich the data sets obtainable by tying together “millions of encounters in real-world settings”. Not sure how you do that over disparate repositories without fully identifying each patient, but those are just details, and surely patients will see the value in allowing decision makers to assess our quality of life for comparative-effectiveness purposes. Anyway, adding some very patient-centered fields, quantifying your happiness or sadness, to the medical record is not going to elevate health care data to the status of Big Data. In order for health care data to become truly Big Data, it will have to be combined with other data sources, such as social media data, Internet search data, financial data, census data, shopping data, cell phone data, and the list goes on. And herein lies the Big excitement.

Of course, once we throw health care data into the boiling cauldron of Big Data, many wondrous things can emerge along with some nightmarish ones too. The only (legal) tool for extracting health care data from the HIPAA covered ecosystem today is the patient, because the patient is the only one who can legally “transmit” data from a covered entity to one that is not hampered by such details, like the various standalone Personal Health Records provided by private companies and all sorts of other health and wellness tools built by eager entrepreneurs. Once those shiny new “Transmit” buttons are added to patient portals, per Meaningful Use Stage 2 rules, there will no doubt be dozens of tools competing for “informed permission” from patients to crawl health care providers’ portals and auto extract everything possible and aggregate it “on behalf” of the patient. Will patients cooperate and donate personal health records to the Big Data enterprise? Perhaps a few, but not enough to make the bells ring. There will need to be a few more rounds of rulemaking before patient data can be truly liberated from those antiquated HIPAA protections, and properly used to build a few fortunes and to improve the quality and accuracy of the coupons we receive in the mail.

Saturday, March 10, 2012


I love persimmons with their luscious flavor and their rich exotic texture, but parsimony has nothing to do with persimmons. For the 99% of Americans who are less familiar with the term parsimonious than they are with the rare persimmon fruit, here are the suggested synonyms to parsimonious, according to the Merriam Webster dictionary: “cheap, chintzy, close, closefisted, mean, mingy, miserly, niggard, niggardly, stingy, penny-pinching, penurious, pinching, pinchpenny, spare, sparing, stinting, tight, tightfisted, uncharitable, ungenerous”.

In the sixth edition of its Ethics Manual, the American College of Physicians (ACP) is stating the following: “Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available” [emphasis added]. If you don’t use the term parsimonious in casual conversation, feel free to substitute any of the Merriam Webster synonyms, so you can enjoy the full flavor of this recommendation. We should note that the President of the ACP, Dr. Virginia Hood, while acknowledging that “it has some connotations where people think frugality or being parsimonious is the same as being mean or inadequate”, she does not “think that is the real meaning of that word". According to Dr. Hood “Parsimonious is a good word in the sense that it means that you use only what's necessary". Unfortunately she stopped short of defining “necessary”.

But the term parsimonious can be understood in a different way too. From the Latin “lex parsimoniae”, parsimonious, when scientifically understood could be a reference to Occam’s razor principle “requiring that the simplest of competing theories be preferred to the more complex or that explanations of unknown phenomena be sought first in terms of known quantities”. So perhaps the ACP is advising doctors to refrain from seeking zebras each time they hear galloping hooves, which may be fine medical advice up to the point where it requires respectful consideration for “resources”, which is just a polite term for money. When money is inserted into the scientific equation, we are drawn back to the penny-pinching definition, and since nobody wants to go on record advocating cheap care, we are back to parsimonious and the comfortable ambiguity cover it provides.

As noted in a recent New York Times article, despite this ambiguity, and perhaps precisely because of it, parsimonious care is quickly becoming a very popular term in the industry. In a NEJM article on costs of health care, Peter J. Neumann dares to ask the question and proceeds to answer it too: “Is “parsimonious” the right word? Perhaps there are better ones, but “frugal,” “prudent,” “thrifty,” “cost-conscious,” and others would also raise objections. … Calling it parsimonious is a reasonable start.” Yes, we can’t really call it what it is because it would raise objections. Similarly, we can’t call something a “tax” because it would raise objections, so we call it “penalty” instead, and this too is a reasonable start.

So what does parsimonious care look like? There are no exact descriptions, presumably because they too would raise “objections”, but there are philosophical principles involved. Dr. Zeke Emanuel, for example, is thrilled with the ACP daring to be “a professional society unafraid of advocating the principle of cost-effectiveness”. Cost-effectiveness, which has been in wide use before parsimonious came into vogue, is best examined at the edges where costs differ widely and effectiveness is held constant, or vice versa. It is prudent to stay away from instances where both costs and effectiveness vary widely in direct proportion to each other, because close scrutiny may raise objections. Perhaps this is where parsimonious care kicks in, invoking the renowned 80-20 business rule. If you get injured in an accident and we can restore you to 80% functionality for 20% of the cost, should we really spend the remainder 80% of the money for a measly 20% in diminishing returns to society? 

We may be able to gain additional insight by understanding what parsimonious care is not. A much debated recent study published in Health Affairs concludes that for office-based physicians, electronic access to imaging and lab results does not reduce the frequency of test orders, and advises that “[i]nsurers and health care providers should also be wary of claims that computerization alone will lead to a more parsimonious practice style”. Disregarding the policy implications and the validity of these conclusions, along with the vigorous rebuttals, and sticking with our largely semantic analysis, we may conclude that a reduction in ordering of expensive tests is a characteristic of parsimonious care. Examining the data in this study, which has not been questioned by those taking issue with the conclusions, one should be immediately struck by the fact that doctors in private solo practice are about four times less likely to order expensive imaging tests than physicians employed by hospitals, and significantly less likely to do so than doctors practicing in large group settings.

Since this particular study took the liberty of making some pretty wild assumptions, and since the rebuttals engaged in similarly wild predictions, perhaps it would be beneficial to disregard the multitude of controversial trees and observe the forest in plain view, which reveals that parsimonious care is more likely to be delivered in small private practice. The obligatory implications to policy makers would be to quit the mindless herding of doctors into unparsimonious hospital employment and consolidation, and to conduct some studies of readily available data on the parsimony, or cheapness, of care in various practice settings. The definition of parsimonious care, at least for ambulatory practice, as that which is offered in small private practice settings, and the promotion of the same, is guaranteed to not raise any objections from the public. The alternative would be to continue using terminology nobody understands to make policy nobody understands, while engaging in esoteric conversations for the illuminati who possess the encryption keys to public discourse.

Addendum: For the sake of completeness, here is the brand new response from the authors of the Health Affairs study on imaging, to the ONC rebuttal. (3/12/2012)