Monday, August 24, 2015

Measuring the Doctor-Patient Relationship

Sixty years ago, before he became a controversial figure in the field of psychiatry, Dr. Thomas S. Szasz co-authored an article for the Archives of Internal Medicine (now JAMA Internal Medicine) on “The Basic Models of the Doctor-Patient Relationship”, which is well worth reading today, particularly for those who believe that patient empowerment/engagement is a novel and disruptive innovation of our digital times. The paper is describing three distinct relationship models (i.e. active-passive, guidance-cooperation, mutual participation) and how they flow and morph into each other based on patient ability/preferences, physician characteristics, and illness circumstances. Dr. Szasz is addressing all the contemporary hot buttons of paternalistic doctors, patient values and shared decision making, but more important is the realization that doctor-patient relationships were a concept debated before most of us were born, in much the same way they are debated today.

Since Dr. Szasz made his contribution to the philosophy of medicine before hidden agendas and political correctness dictated how ideas are phrased, he was free to observe that “each of the three types of therapeutic relationship is entirely appropriate under certain circumstances and each is inappropriate under others”, without the compulsory need to assign blame to either the patient who prefers passivity or the physician who complements those preferences in “an interlocking integration of the sick and his healer”. And when a mismatch arises between the preferences of doctor and patient, the relationship is dissolved, “and so life goes on”. But the days of laissez-faire medicine are over, and today we feel compelled to define the, one and only, ideal physician-patient relationship.

As the managed care era descended upon us in the 1990s, Dr. Ezekiel Emanuel felt it necessary to define an aspirational goal for the ideal physician-patient relationship based on six fundamental components (the six C’s):
  1. Choice – For patients, this means choice of practice type and setting, choice of primary care physician, choice of specialist or facility for emergencies and special conditions, and choice among treatment alternatives.
  2. Competence – Physicians should stay up to date, have good technical and diagnostic skills, exhibit good clinical judgement and be cognizant of their own limitations.
  3. Communication – First, physicians should listen and understand symptoms, values, family, jobs and other health related patient concerns. Second, physicians should be able to explain the disease, the diagnosis, treatment alternatives and how those affect patient values, guiding patients through issues raised by their illness, while respecting patients’ preferences for how much they want to know.
  4. Compassion – This is about empathy and helping patients feel supported.
  5. Continuity – Here the paper recognizes that the “ideal physician-patient relationship requires a significant investment of time”, and that frequent changes of physicians undermines such relationship. It also acknowledges that “relationships that endure over time may be more efficient” both by helping doctors treat the patient in more appropriate manner and by fostering patient trust and confidence.
  6. (non) Conflict of interest – Personal and financial interests are emphasized, but the expectation seems to be that “a physician’s primary concern will be his or her patient’s well-being, even though physicians may have obligations that conflict”.
The remainder of his paper explores the many ways in which managed care is positioned to attack all six components, and concludes by stating that “the physician-patient relationship is the cornerstone for achieving, maintaining, and improving health”.

Dr. Emanuel’s definition of the doctor-patient relationship is very broad, and with a few minor additions and deletions, it can also serve as a definition for what we now call patient-centered care. Perhaps it is not by accident that the term “patient-centered medicine” was introduced into common parlance by Enid Balint, the wife and collaborator of Michael Balint who was one of the earliest researchers of the dynamics between doctors, patients and illnesses. Michael Balint went as far as to suggest that the doctor himself was actually a therapeutic “drug”, while Enid Balint envisioned the skills needed in the practice of patient-centered medicine to be “in the way that the doctor allows the patient to use him, rather than in the way the doctor responds to the patient by his interpretations and theories”.

Whereas the contemporary definition of the physician-patient relationship (and subsequently patient-centered care) consists of a rigid set of presumably ideal physician characteristics, the Balints, and to a certain extent Dr. Szasz, saw the physician as a tool to be personalized by each patient and further customized for each illness situation. It is difficult to imagine a more egalitarian or participatory relationship than this one. In fact, Dr. Emanuel’s six C’s can be seen as just one particular facet of the malleable relationship proposed by Enid Balint. In a perfect world, we would concentrate on creating an environment where physicians are able to allow themselves to be used by patients, and trust that good things will happen to both parties as a result.

But in our current world of ingrained distrust and defensive measurements, we feel compelled to digitize, tabulate, rank and rate the doctor-patient relationship, just like we measure everything else. First, the ubiquitous patient experience surveys provide a coarse measure of how patients experience the communications component of the relationship. It is interesting to note that patients are not asked about their preferences, but whether the “provider” did this or did that, presuming that this or that are what the patient wants the “provider” to do in all situations. Can we infer from a highly scored experience survey that the patient has a useful relationship with her doctor? Not really.

Then we have the periodic surveys asking patients to rank the importance of physician attributes, which always include physician compassion and communication patterns, but rarely other components of Dr. Emanuel’s six C’s, and never the chameleon abilities proposed by Ms. Balint. The presumed intent here is to impress upon physicians that they should focus on the highest ranked attributes of the relationship because they matter more often to more people. Some researchers went as far as to define frameworks for measuring the relationship itself, and formal screening instruments to score it from a patient perspective. Those tools seem a bit more pertinent since the questions are about the patient and her perceptions, instead of inquiries about sanctioned physician activities, and because no assumptions are being made regarding the “right” kind of relationship (a Dutch example is depicted below).


Perhaps a combination of the former and the latter, along with objective information, such as assessment of choice, conflict of interest and competency, can get us closer to a meaningful measure of the doctor-patient relationship. Careful analysis of result sets would allow us to answer two basic questions: are patients getting what they value most, and are those fortunate enough to have the relationship they desire experiencing better medical outcomes. Examining the characteristics of both patients and doctors, could yield actionable insights into optimal practice models. Strangely though, in spite of the billions of dollars spent on “patient-centered” research to date, I am not aware of any such study, or serious attempts at anything remotely similar. One can only wonder why.

Although there is ample rhetoric about the doctor-patient relationship and patient-centered everything, much of what we do in health care today is in stark contradiction to Dr. Emanuel’s ideal six C’s, not to mention the revolutionary ideas of the Balints. Patient choice is being curtailed by a bewildering array of narrow network health plans and wholesale clinical decisions made by corporate CEOs. Competence is being redefined to include care provided by non-physicians, non-clinicians, and algorithmic software. Continuity of care is being discouraged in favor of cheapness, convenience and continuity of medical records, while conflict of interest is inherent in all so called value-based arrangements. Compassion has been scripted by marketers, and communication, precisely codified for the eclectic, self-managing, highly educated, financially secure, and largely healthy, patient segment, has become the second most important factor defining the interaction between patients and the health system. The premier factor is of course, access to all of the above.

I don’t think I can agree with Dr. Emanuel’s opinion that the physician-patient relationship is the “cornerstone” of health, but it might very well be the cornerstone of healing. I don’t know how healing the sick affects the myriad measures we are currently collecting, reporting and analyzing with such zest. Some argue that a satisfactory doctor-patient relationship is conducive to patient adherence, increased ability for self-management, and decreased utilization of hospitals and emergency services. If these assertions are even partially true, then the doctor-patient relationship has serious implications for the most important aspect of health care in this country: money. And as such, defining, supporting, and, yes, formally measuring and analyzing the doctor-patient relationship may present a rare confluence of interests between corporate greed and basic human dignity.

Monday, August 3, 2015

The DoD EHR: Ah Hell, Let's Try Again

The health information technology (HIT) world has been hit by a watershed event like no other. The Department of Defense (DoD), widely respected for its indiscriminate generosity to contractors, has awarded the most coveted prize in recent HIT memory – the Defense Healthcare Management Systems Modernization (DHMSM) contract. And the winner is... Leidos, the contractor formerly known as SAIC. A couple of years ago, when the race for the DoD contract began, Leidos/SAIC selected Cerner as its EHR of choice for this contract. The smart money though was on Epic and its Big Blue partner because they are and seemingly always have been the safest procurement choices for top brass in any large organization.

A stunned HIT “community” initiated its favorite game of providing post facto authoritative explanations ranging from cute to grotesque. Here are the most common and least specious opinions. The interoperability lobby offered Cerner’s recent and vocal leadership in organizing a national information exchange as the reason for the DoD choice. Others, who may have been bothered in the past by the prices Epic was able to command, suggested that the relative cheapness of Cerner must have tilted the balance. The technically inclined opined that the Cerner architecture is more modular and hence a better fit for DoD needs. These theories and more may all hold some truth, but what we all seem to forget is that the DHMSM contract was awarded to Leidos, and Cerner is just a subcontractor.

In September 2013 the Science Applications International Corporation (SAIC), one of the largest defense contractors in the U.S., changed its name to Leidos Holdings, Inc. and spun off a smaller entity that retained the SAIC name. The split was explained as a way to avoid conflict of interests and get more business. The classic SAIC expose, written by Donald L. Barlett and James B. Steele, and published in Vanity Fair in 2007, should be required reading for anyone trying to understand why the DHMSM contract award was pretty much preordained. Epic lost the day it partnered with IBM, and Cerner won the day it selected, or was selected by, SAIC.

Back in 1988 SAIC was awarded a $1 billion dollar initial contract to design, develop, and implement the Composite Health Care System (CHCS). When the first version of the CHCS turned out to be lacking, SAIC was awarded a contract to replace it with CHCS II. Over 27 years SAIC has evolved the CHCS into the current Armed Forces Health Longitudinal Technology Application (AHLTA) through design, redesign, rip-and-replace, integration and deployments in military facilities of all types around the globe. The DoD was very proud of the new $1.2 billion AHLTA back in 2005, but in time it became fondly known as an acronym for “Ah Hell, Let's Try Again”. Nevertheless, SAIC kept raking in support and development contracts for AHLTA, since according to the DoD, SAIC “is the only vendor capable of supporting functional and technical system changes due to their unique experience and familiarity with the system”.

After CHCS and AHLTA, now comes DHMSM, and there is absolutely no reason to believe that the DoD changed its opinion regarding SAIC’s unique capabilities. Spending billions of dollars on one failed solution after another does not seem to be a problem for defense contractors, or government contractors in general, and in all fairness SAIC does have decades of experience in the unique deployment needs of the military, which are vastly different than your typical posh academic center in the homeland. Perhaps throwing a decent commercial EHR in the mix will finally break the perpetual cycle of failure the DoD has become accustomed to paying for. One can only hope.

The more interesting question for non-military HIT is how the DHMSM contract will affect the orders of magnitude larger commercial EHR market. Will Cerner leapfrog Epic and become the EHR of choice for large health systems? Will Cerner be so bogged down in military work that it will start losing ground in the private market? Will Epic repent and submit itself to the Cerner led CommonWell interoperability (data collection) bandwagon? Or alternatively, will Epic snap out of its self-imposed silence and mount an aggressive marketing and PR campaign? Will distant competitors somehow be able to take advantage of the turmoil and take the market by storm? Or maybe, just maybe, once the headlines die down in a few weeks, and we move to the next big thing, nothing will have changed.

The DHMSM contract is very large by comparison to private EHR contracts, but it is not as large as it looks. The initial award is for $4.3 billion over the next 10 years. Multiplying by at least 2, since after all this is a Pentagon contract custom built for SAIC, we are looking at approximately $860 million per year on average, over the next decade for SAIC, Cerner and dozens of other subcontractors. An optimistic estimate of Cerner revenue would be around $80 million per year (HIStalk estimates a more conservative, and probably more realistic, $40 million per year). To mere mortals this may seem like a lot of money, but considering that typical hospital EHR implementations run anywhere between tens to many hundreds of millions of dollars, and considering that Cerner has annual revenues of around $4 billion, the DoD contract seems like a modest contribution to an already gigantic EHR powerhouse.

Speaking of money, it does seem rather excessive to spend so many billions of dollars on a piece of software. Nobody knows how many billions will end up being spent, but we do know that $4.3 billion is the absolute minimum over the next 10 years. Is that a lot? The DoD has 55 hospitals and more than 600 clinics, and it has aircraft carriers, submarines, helicopters and all sorts of personnel carrying vehicles where the EHR will need to be used, not to mention remote caves in foreign lands, and theaters of full blown war. Neither Cerner nor any existing EHR, including VistA, has those capabilities out of the box. Certainly lots of new code will need to be written by Cerner, but the bulk of the money will go to integration and deployment. That money is SAIC money and is independent of EHR choice (this is a good place to go back and read that Vanity Fair article).

There is however no doubt that the DoD contract is a huge marketing win for Cerner, and this is amplified by the fact that Epic does little to no public marketing of its own. The Cerner award will also have beneficial effects on the CommonWell data exchange platform. The already significant influence Cerner exerts on government agencies, such as ONC, will likely increase and that’s a very good thing for Cerner’s commercial business. More important though is Cerner’s foot in the door at the Department of Veteran Affairs (VA), just in case they decide (or are forced to decide) to keep up with the DoD and replace their VistA EHR.

So far the experts and the media have been kind to Cerner, and will continue to be so as long as the DHMSM project moves successfully through its milestones. However, as a subcontractor, Cerner has limited control over the project as a whole, and considering that in the world of SAIC, success is defined as extracting the largest possible annuities from the government, whether its deliverables are fit for purpose or not so much, Cerner is running a significant risk of having its otherwise respectable reputation tarnished through no fault of its own. Not sure why, but my feeling is that Cerner has a much better chance of surviving inside the shadowy defense contractor culture than Epic would have ever had, so things may turn out just fine.

Health care nowadays is like the ticker tape of a hyperactive stock market gone mad. Everything is huge, disruptive and transformative for a few days until the next seismic shock rolls in. Since nothing means anything in particular, everything means exactly what each expert wishes it would mean. For some the DHMSM exemplifies the triumph of interoperability and the demise of information blockers. For others it is clear proof that the future belongs to platforms and substitutable modules. Many are just thrilled to see a previously unbeatable contender take one squarely on the chin. And a few feel personally persecuted because a big iron EHR vendor was selected instead of something from the app store. Truth is that the DHMSM means very little to anybody in the EHR industry, other than Cerner of course.

Sunday, August 2, 2015

Excerpts from a Doctor's Personal Journal

Guest Post by ANONYMOUS PHYSICIAN

4/18/13 …finally certified as a PCMH with NCQA. We’re meeting Meaningful Use requirements and are busier than ever. It seems I’m staying at the office later and I haven’t seen any of the expected profit yet, most of the increased reimbursements have barely offset the added costs as far as personnel and IT, but now we can prove the quality of the care we provide…

4/25/13 …at dinner with the family I realized how chaotic my home life is, no structure like at work. I was late getting dinner ready, Thursday is my night to cook, and I didn’t have all the ingredients so I had to run to town and still forgot to buy milk. I needed to pay bills but hadn’t transferred any money to the checking account and had used up the last of the checks without ordering more…That night the twins Annie and Amy were pestering my wife Kate about soccer camp, and Glen was talking about his latest baseball game, he made the varsity baseball team as a sophomore playing first base. Kate, who runs her own business as a florist, observed that at work she has systems to track orders and deliveries, but at home we can run out of milk and no one says anything. It got me thinking…

5/16/13 …after dinner the kids had finished their homework and were starting a game of Monopoly and Kate was about to settle down with her book when I called everybody together for an impromptu family meeting. I proposed that we build a Family Centered Personal Home (FCPH) based on the same principles of the PCMH I had learned at work. I suggested we could have written family procedures and protocols for all the important stuff, and we could track our progress if we digitized and automated as much of it as possible. We would develop a team approach with everyone functioning at the top of their abilities. The kids were excited when I told them we would each need our own IPad connected with the home computer, but Kate was skeptical and wondered how it would help and what it would cost.  Eventually my enthusiasm prevailed and Kate agreed to try. I know that if we can collect enough data and use the right quality metrics we can optimize the FCPH…

8/22/13 …it’s taken all summer but I think we’re ready to begin in time for the start of the new school year. I used all the spare time I had this summer writing protocols for everything from paying bills to homework and piano lessons. I took the money we would have spent on weekend outings and invested in a new home computer and IPads for everyone. I had an IT guy at work help me modify some basic software and spreadsheets to structure our initial data collection, later I’ll need to invest in better software to help interpret the data we collect…

8/29/13 …Ready to roll! I explained tonight that the new computers are tools and not toys, we’re going to use them to track our progress. I showed each of the children how to use the preloaded spreadsheets to track their time spent on homework, chores, piano and violin practice, school attendance using GPA as an outcome metric, and so forth. I included detailed procedures for everything from teeth brushing to basic hygiene and meal prep, expectations for laundry, vacuuming, dishwashing, and lawn mowing... Glen was excited to see I’d included a program to track his baseball batting average. It’s important for children to have some unstructured time to pursue their own interests and hobbies so I built that into the detailed preloaded schedules customized for each of them. For Kate and me, we have the added responsibility of tracking household finances, kitchen and pantry inventory, transportation expenses maintenance and repair, etc. I mirrored some of the children’s software on our computers too so we can have reminders of important events like recitals and soccer games….

8/30/13 …today I introduced the family to the rest of the team, just as with the PCMH Kate and I can’t be expected to do it all, so I’ve hired some surrogate help in the form of tutors, nanny, personal trainers, gardener, and housekeeper. I have outsourced accounting, IT development and most home maintenance responsibilities. Extended family can step in to fill some functions when Kate or I aren’t available. I’ve had to forgo any retirement savings this year and we might miss a mortgage payment or two, but it will be worth it in the name of quality…

9/2/13 …I had to password protect the Intimate Relations protocol and data set on the shared server, it was generating too much interest. I need to talk to Kate about measuring quantity as well as quality as a metric…

10/10/13 …pulled Amy aside tonight and had a stern father-daughter chat, she just hasn’t been tracking her data like the rest of us. She complained it was too much work, that all the data entry was actually keeping her from performing the tasks she is supposed to track. I explained that I completely understand, and that based on my experiences at work the documentation is always more important than anything else so sometimes you have to fudge a little bit in order to get everything done. Without the data we can’t measure how well we’re doing and if we can’t measure it how can we improve? She cried and tried to argue that sometimes the intangible things in life are more important, but in the end she saw things my way and promised to try harder…

12/12/13 …During dinner tonight everyone was quiet, the cacophony of conversations we would have heard last year at this time is gone, instead everyone has their head down rapidly pecking away at their computer screens documenting their activities of the day…we don’t seem to be interacting nearly as much but the pantry is well stocked and the oil/filter in the pickup was changed on time for once…

1/16/14 …reviewed the children’s report cards from fall term and Annie’s grades have fallen. Looking through the automated reporting features of our user friendly software it appears she has been keeping up with her homework, and the chore tracking feature reveals 100% performance, everyone else is tracking around 65% to 80% with a performance incentive set at 72.3%. My personal observations make me question the veracity of Annie’s outcomes, but it’s hard to dispute the data…

2/13/14…Glen is in the front yard playing catch with Nathan his personal trainer, the twins are at the kitchen table with Brenda their mentor working on their algebra, both tasks I used to have to do. This has freed me up to do more important things… I just discovered all the tires on our mountain bikes are flat, they’ve probably been that way for months and nobody noticed, I’ll need to add a bicycle tire pressure monitoring protocol to Glen’s garage inventory and maintenance duties, maybe I should sell the bikes, we haven’t used them in almost a year…

3/27/14 …spent the first couple of days of spring break tweaking our protocols and procedures for the FCPH and letting the kids catch up on their reporting. Was surprised to learn that Glen isn’t going out for baseball this year, he says he just doesn’t have the time…

5/15/14 …Amy is still having a hard time, tonight she complained that our relationships are suffering, she observed that we haven’t played a game of Monopoly in over six months and our dinner conversations are curtailed as we all rush to finish the meal and clean up so we can complete all the documentation needed for the FCPH. It was difficult for me but I had to explain to Amy that in any endeavor like this sacrifices are necessary. At the office before we became a PCMH I used to think that my relationship with my patient was paramount and that I could effect a better outcome by getting to know and bonding with my patients respectfully. Our transformation to the PCMH taught me that I wasn’t doing such a good job. Some of my patients that I’d been treating for years weren’t following my advice and were skewing the metrics used to incentivize me so they had to be discharged from care. I explained to Amy that just as I’ve had to sacrifice any antiquated notions about relationship building in clinical medicine in order to optimize my outcomes, so too must she jettison any such unreasonable expectations as we perfect the FCPH…

6/18/15 …our household is running like a well-oiled machine, and I can prove it! We had to let the housekeeper and gardener go so we still have some issues in those realms, but everyone has very well defined roles and responsibilities… sometimes there can be a lot of finger pointing when things go wrong. I haven’t talked to Amy in weeks, there are still some discrepancies in Annie’s data and actual outcomes I haven’t put my finger on yet, and Kate seems more distant somehow. Glen no longer talks about going to medical school after college. On the computer I can show you how we’ve improved on so many metrics in the last two years, I can’t imagine trying to run a household without the FCPH…

The author is a family physician in solo practice.

Opinions expressed by "On Health Care Technology" guest bloggers are their own.

Tuesday, July 28, 2015

Back to the Future Garden of Eden

The very first thing Adam and Eve did after acquiring the wisdom to distinguish between good and evil was to cover themselves up and hide from view. Privacy was the first concern of a newly enlightened humanity. The punishment for acquiring this peculiarly human self-awareness was harsh, swift and unforgiving. Yes, it is legend, but you should never underestimate the genius of an author whose collection of stories has been the number one global bestseller for almost six millennia and counting. Today, a new legend is forming. If we agree to take off our loincloth and step out from the shadows of our privacy, the eternal punishment of blood, toil, sweat and tears will be rescinded by a new generation of supreme beings.

Is it possible for us to unbite the proverbial apple? Is it possible for us to revert to naked grazing among the magnificent bounty offered by the new gods, completely oblivious to benevolent surveillance and unobtrusive discipline? Our government thinks so. The billionaire class thinks so. And many of us agree and think it’s for the best. After all, honest people have nothing to hide, nothing to be ashamed of, and privacy has no tangible benefits anyway. Better yet, a little less privacy, and a little more supervision, for criminal elements and people we don’t like, is probably a good thing. Insisting on an archaic “right to be let alone” in a globally interconnected world, other than being laughable, is hindering the democratization, simplification, cheapification and commoditization of all life’s endeavors, including prevention of disease and curing cancer. Privacy is the last barrier to an eternal life of leisure and joy.

There is currently a well-coordinated, well-funded and extremely successful campaign to help us shed the ball and chains of privacy. Whereas three quarters of a century ago we realized that work made us free, today we recognize that sharing our private information will bring us personal liberty. Freedom and liberty, contrary to what you may have learned in kindergarten, are earned by hard work and individual publicness. Since the innocent days of prancing naked on the banks of the Euphrates, we learned the hard way that free markets are the engine, the heart and soul, of humanity, and free markets are hampered by the original sin of privacy, which introduces an information asymmetry that makes the markets anything but free. To liberate ourselves, we must liberate our markets first.  

America, as usual, is leading the way in liberating international markets. Our unique form of government with its three famous branches of corporate, lobbyist and executive is best suited for freeing humanity, because our government has evolved from representing a small group of citizens to representing global markets. For those too old to see the glory, rest assured that there are large checks flowing freely between the three government branches and balances are meticulously calculated by our leaders. The Singularity, you see, is not a nebulous prophecy about cyborgs. The Singularity is here and now, as this is the precise moment in human history where governance, technology, apathy and savvy leadership are perfectly aligned to take us back to the future Garden of Eden.

On Friday, July 10, 2015 the 21st Century Cures Act was passed by the House of Representatives of the U.S. Congress with overwhelming bipartisan support. Relatively speaking, the bill is rather short and concise at 362 pages, so one can be certain that our wise representatives have read every syllable and understood all the technical intricacies of this groundbreaking legislation before casting a vote. Having been a skeptic in the past, I must admit that I am particularly awed by the mathematical prowess of our legislators who empowered the Secretary of Health and Human Services to require that scientists use Bayesian statistics in their pharmaceutical research.

The Act that will cure us in the present century is the culmination of a gigantic effort by the corporate and lobbyist branches of our government to bring potentially lifesaving medicines to the market faster, in larger numbers and at lower costs to the manufacturers. To accomplish this the Act is cutting through the useless regulatory red tape of the Food and Drug Administration (FDA) and bypassing the obsessive scientific insistence on rigorous clinical trials, which can take decades to produce an approved medication, while people continue to needlessly die. Instead, an iterative and more agile process is being put in place by the Act. Do a little research, a little testing, a little checking and regulating, fail soon, fail often, and pivot quickly based on post-market laboratory surveillance.

Sure, people will continue to die (not necessarily the same ones and perhaps a few more), but now they will die for a good cause. The road to heaven, you know, is paved with necessary atrocities. Privacy of course is not congruent with the needs of a learning laboratory system, and the Act has taken the first steps to remove some of the anachronistic obstacles erected by the privacy sections of HIPAA. Once the Cures Act becomes the law of the land, personal health information will become shareable for research purposes, and the cumbersome need to obtain informed consent from human research subjects will be waived if illustrious researchers estimate that the experiment poses “minimal risk” to those experimented upon. Illustrious researchers have always been humanitarians first, and scientists second (savage sadists was a distant third), so we should be fine.

Less than a fortnight after the Cures Act swished through Congress, the lobbyist branch came up with a whitepaper to guide the next steps in our road to redemption.  Calling it as Oracle, IBM, Intel and PhRMA, all esteemed members of the corporate branch, see it, the lobbyist prescription is to dismiss any shreds of privacy and self-determination laws left standing, including the Common Rule which protects the rights of human subjects of medical research. The Common Rule is the American implementation of the Declaration of Helsinki, which was developed by the World Medical Association, following the peculiar events that led to the creation of the Nuremberg Code. The Common Rule is thus a relic, an overreaction to a bunch of idiots who thought they could somehow engineer a perfect race of humans, and among other things engaged in ample exploratory research. Stuff like that cannot happen anymore, because now we have Internet, so it’s time to get over it, put it all behind us and move forward.

Privacy rules, you see, have “opportunity costs” for the corporate branch of government, and as such are strongly affecting the movement of checks between the branches, and the size of balances everywhere. The lobbyist whitepaper is making an exceedingly compelling argument for permitting unchecked collection and trade in all sorts of personal information, not just medical or genomic. The banks have been doing it forever and it's all working just fine, other than a little innocuous leakage into marketing databases. Why should other corporate clients be treated differently than the banks? It’s simply not fair, and “lives are being lost” because of our failure to equally protect all corporate members from undue regulatory burdens. A stark example of unfairness is the preferential treatment afforded to the Centers for Medicare and Medicaid Services (CMS). 

On November 13, 2014, the CMS published a final rule regarding its physician fee schedule for 2015. Tucked neatly inside it, there is a little section promising to “provide clear legal authority for Health Insurance Portability and Accountability Act (HIPAA) Covered Entities to disclose any required protected health information” to the CMS. The “required” disclosure is for information ranging from clinical to “health behaviors” to a catchall “other data”, such as “participant employment status, participant educational degrees pursued/achieved, and income”, all “with identifiers that allow linkages across time and datasets”. The subjects of said disclosure are all entities “participating in the testing of past, present, and future models” funded by the CMS, including people not covered by the CMS, which is pretty much all people in this country.

The CMS needs the information to evaluate results of research projects, which by its own admission could have adverse effects on participants, with no mention of informed consent being needed from test subjects. How is this fair? If the CMS is asserting such latitude, why shouldn’t the corporate branch enjoy equal opportunities? What has the CMS done for you lately? If you are going to trust someone, why not trust a good solid brand-name, like say, the Coca-Cola polar bear, or the Marlborough man? If somehow doctors came to your mind in this context, the lobbyist whitepaper is quick to point out that, by winning Jeopardy, IBM’s Watson proved once and for all that “doctors are no longer the experts they once were”. And no whitepaper can be complete without reminding us that if we don’t get our act together quickly, China is going to eat us for lunch.

So that as they say is that. We must comply. Yes, for some of us it will be a little awkward in the beginning, but many have already made the transition, and frankly they seem to be just fine. This is after all an inevitable stage in human development. After losing our innocence, we began eking out a meager and perilous living by scratching food from the dirt beneath our feet. We looked underneath the dirt and discovered carbonized dead vegetation and digging deeper we found other fossilized lifeforms. We sustained ourselves comfortably on the dead bodies of those who came before us. For a brief moment, we looked up and considered the infinite bounty of the universe, but that seemed too hard.  The disruptive innovation of our times is to fast forward to a distant past and turn on each other to extract untold fortunes from mass digital cannibalism.

Tuesday, July 14, 2015

Health Care Viewed from Alpha Centauri

If someone was sitting on a veranda somewhere in the Alpha Centauri system, reading about health care in America of planet Earth, one would most likely conclude that the family of viruses known as the common cold are destroying a health system already crippled by a glut of poorly educated physicians practicing their miserable craft on a slow-moving and slow-thinking bovine population. One would also be likely to feel optimistic, because, America is bravely tackling its health care problems head on, and a resolution is all but imminent. Relieved, the sympathetic observer would take another sip from his refreshingly molten krillonade, and fast forward to the intergalactic sports section.

As our Alpha Centauri Aamericanophile surely gleaned from far away media reports, retail medicine is the fastest growing and most talked about innovation in American health care. Retail medicine comes in two closely related, yet very different flavors: cramped little rooms in the back of brick and mortar convenience stores, and cramped little apps from forever scrolling websites on mobile Internet devices. There are also hybrid solutions that combine the store backroom with the Internet in one glorious health care kiosk. Nurse practitioners or physician assistants are always provided, but for now, physicians are offered for sale exclusively through the Internet.

All three models address the most immediate and most prevalent health issues at a fraction of the costs and the hassles of traditional medicine. As the public gets educated on the endless possibilities afforded by these innovations, health care should become integral to everyday life to provide much needed safety and peace of mind. For example, say you are at your desk at 3pm and get one of those annoying eye twitches for no apparent reason. One push of a button will get you in front of a smiling doctor to allay your worst fears. A few hours later, while changing the baby, you notice a faint rash. Will it get worse? Is it infected? One click of a button and strategic placement of your mobile device will allow a board certified dermatologist to answer all your questions. Next morning, your eight year old refuses to get dressed because his tummy hurts and he is not feeling well. Why gamble? Another easy click and a pediatrician will look at little Jimmy right then and there in his bedroom, and see that he gets to school on time.  

You would certainly not click that button if the baby was burning up and wheezing, or if Jimmy slipped in the bathtub and cut his forehead, but you know, for the little things, the doctor button is a life saver. It makes you feel safe, like you’re never alone, and that’s worth every penny for a busy working mom.  And not just working moms. There are hundreds of millions of little health things happening every day in America, and if everybody used the doctor button on their phone for each one, America would save billions of dollars, because traditional doctor visits and emergency room visits are two to ten times more expensive than doctor apps. Of course, it will take time to build virtual capacity, but seeing how entrepreneurs are knocking each other out in a mad rush to help the country, it won’t be much longer before every American is safe from worry.

When our technology is as good as that of Alpha Centauri, virtual medicine will be all we need, but in the interim there are other little things that sadly require physical proximity to certain apertures and chemical compounds. For that we have brick and mortar retail clinics, conveniently located at the corner of every street, or so it seems. Retail clinics can do more than virtual doctors in the way of blood tests and physicals, but the most important benefit is the immediate access to pharmacies, and other stuff people often purchase. Retail clinics will eventually go the way of the old doctor’s office, but until then they will pitch in and help us save billions of dollars more by covering all remaining little health things that are not yet virtualized.

You may wonder about the big things in health care, those that are consuming all our resources right now, but from the Alpha Centauri vista, the big things don’t look so big. First, big things are rather rare as it is, and are affecting mostly non-productive members of society. Productivity, as Earthlings are about to discover soon, is what makes the Cosmos tick. Second, as America begins to invest its resources in waves of little things, a resonant frequency will be achieved. The incremental effects of successively applied inconsequential actions are cumulative, and will eventually give birth to infinite natural health amplitudes. The process is called prevention, and it is a fundamental law of interstellar biophysics, which causes big things to gradually evaporate. 

Now that we know how wonderful things will turn out to be for us in the future, the only remaining question is what we should do with the doctors. They served a noble cause and they were instrumental in bringing us to the cusp of an unprecedented quantum leap in human health. But just like freedom fighters everywhere, and our own olden days militias, once the goals are achieved, there comes a time when rugged individual heroism must be replaced by well oiled machines to protect those achievements.  We will always look back fondly on Paul Revere, Ralph Steinman, John Paul Jones, Eugene Braunwald, Joseph Warren and all other heroes of past struggles, but we won, and now we must build armies of uniformed and rigorously disciplined soldiers.

Preventive health will need its generals to be sure, but our future health workforce will consist mostly of “virtualists”, to borrow an Alpha Centauri term. A virtualist is what you see and hear when you push the doctor button on your mobile device.  A virtualist is a doctor trained in the intricacies of health’s little things. He or she is supported by precise protocols and a vast array of technologies interconnected by the Internet of Things (IoT). This will save America billions of dollars in education and training, while adding a decade of productivity to each doctor. We will keep the doctor title because its original meaning of teacher is even more accurate in the new order, than it was during revolutionary times. It will be a health doctor, or HD, instead of MD, because medicine is only needed when health fails, and once we reach the resonant frequencies of prevention, health will never fail us again. 

So what’s to become of our doctors? They will adapt. They are adapting. Some are already virtualists. Many are hooked to the doctor button part of the time. The majority will follow suit. But, as is the case for any reorganization that demands strict discipline and obedience, some old warriors will be unable to make a successful transition. A few will die tilting at the windmills of progress, while others will become doctors of fortune, selling their very particular set of skills to discerning customers. Two, three, four, perhaps five generations, a mere blink of an eye for our Alpha Centauri observer, and it will all be over.

Monday, June 22, 2015

A Proposal for Disruptive Regulation of EHRs

The latest salvo in the interoperability and information-blocking debate comes from two academic experts in the field of informatics, and was recently published in JAMIA. In the brief article, Sittig and Wright are endeavoring to describe the prerequisites for classifying an EHR as “open” or interoperable. I believe the term “open” is a much better fit here, and if the EHR software happens to come from a business dependent on revenues, as opposed to grant funding from the government, bankrupt may be a more accurate description. Since innovation in the EHR market seems to lack any disruptive effects, perhaps a bit of disruptive regulation would help push everything over the edge.

Although the article seems to be just another shot at Epic, the currently #1 EHR in the country, which is privately owned and run by a woman (a seemingly irritating anomaly in the EHR world), it does have some interesting points worth exploring. The authors propose five overlapping use cases to describe functionality that is important to five stakeholder groups: clinicians, researchers, administrators, software developers and lastly, patients. Let’s look at each one in more detail (pay attention, since we’ll have a quiz at the end), and keep in mind that these requirements are meant to be enforced on all EHRs, including the relatively cheap little one you have in your office.

Use case 1: Extract

The first use case states that a client facility should be able to extract patient records from an EHR, while maintaining granularity of structured data, with the goal of creating “a new secondary-use database”  for internal purposes, or most likely for research. To enable the client to extract data and migrate it to a different database structure, the EHR vendor is required to provide the client with its “data dictionary”. A data dictionary is a detailed description of the EHR database schema, all its tables, views, data types, what the data means, how it connects to other tables, constraints, references, packages, procedures, and a whole lot more.

For the less technically inclined among us, the database structure, or the model, of a serious transactional software application is its heart and soul. The user interface, which is what you as a user see every day, is secondary and easily changed. Chances are that if you used the same EHR for a few years, you have witnessed such changes multiple times. You can certainly build a horrific user interface on top of an excellent model, but you can never build a great user experience on top of a lousy data model. The database structure is not written in stone either, but changes to the model entail excruciating effort and huge expenditures. The data dictionary, if done well, is both description and recipe for recreating the entire application, and as such it is the main portion of a vendor’s intellectual property.

Data dictionaries are usually provided to large clients that host their EHR onsite, and are mostly used to build interfaces with other systems. As health insurers continue to dump risk on health systems, database extractions are increasingly being used for other purposes as well. In the ambulatory market, data dictionaries are not usually shared with customers, since small practices have little to no ability to do independent software development. If your EHR is hosted in some cloud, in truly multi-tenant software as a service (i.e. data from multiple customers is stored in one database structure), you will not get any dictionary and you will never be allowed to access the vendor database, and rightfully so. The best you can hope for in this case is a data dump from your vendor.   

Use case 2: Transmit

This use case is a slightly expanded version of the current Meaningful Use requirement to generate and transmit clinical information in standard format (e.g. C-CDA) to another clinical facility or to an external personal health record (PHR). The goal here is to facilitate referrals or other transitions of care, and to prop up third party PHRs that nobody is interested in using.

Use case 3: Exchange

Here EHRs are required to be available 24/7 to accept programmatic requests from other EHRs for patient records. I am not sure what the significance of 24/7 is in this context, but basically the EHR should be able to respond to ad-hoc queries from any other EHR, locate the requested records, if any, and return a standard based response to the requestor. This use case is supposed to facilitate EHR agnostic community-wide health-information exchange, presumably (and strangely) without using a health information exchange (HIE) entity as mediator. Another peculiarity is the completely superfluous demand that the responding EHR should make its data dictionary available to all querying EHRs, which boils down to publishing the whole thing online, or on demand, for all competing (and aspiring) EHR vendors to enjoy, and to further democratize the hacking industry.

Use case 4: Move

This use case is intended to reduce costs of switching EHR vendors, while ensuring that all data in the old EHR, including metadata and transactional histories are transferred to the new system. To better understand this noble requirement, let’s look at how easily a health system can switch banks. If an organization uses say, US Bank for ten years, and then wishes to transition their accounts, to say, Bank of America, US Bank will first provide its complete data dictionary to the switching organization to be shared with Bank of America developers. Then US Bank will provide an extract of all financial data, including historical transactions and all metadata (e.g., timestamps, source, and authors) so everything is migrated and preserved in the Bank of America system. Other than the logos, the organization would not see any difference really, and this will all be done for little to no cost to the switching health system. If this has not been your experience, then you should call the banks and complain.

Use case 5: Embed

The fifth and last use case is about application programming interfaces (APIs) on steroids, and it enables health systems to develop new EHR features or functionality and seamlessly incorporate those into the EHR. This implies full access to read, edit and delete database content, as well as ability to augment database structures, while the original EHR is expected to incorporate these changes automatically into its basic services such as security and privacy. Essentially, an EHR should become a development platform with functionality exceeding that of the best operating systems out there. For example, if an EHR lacks the ability to collect and process PHQ-9 data, an institution could develop such functionality independently, while the EHR will be expected to incorporate the functionality in its own workflows, screens, decision support, and HIPAA protections, practically out of the box.

Putting all five use cases together and using a tortured way to come up with an acronym, the authors dubbed their framework for defining an open and interoperable EHR, EXTREME, and extreme it is. The framework is written from the point of view of a large health system dealing with a large EHR vendor, and understandably so, since this seems to be the authors’ natural habitat. Applying this framework to the hundreds of EHRs and EHR modules that have been certified by the government to date will ensure that this big business habitat is the only model left standing. There is a cost to transitioning a software package from being a product or a service, to being a development platform. That cost is beyond the reach of most existing EHR companies. For the remaining few, the cost will eventually be passed down to current customers, as was the case with all government mandates imposed on EHRs. Small practices and small hospitals, already struggling to stay afloat, will be dealt the final coup de grĂ¢ce.

The authors state that this upheaval is necessary “if we are to realize the enormous potential of an EHR- enabled health care system”. Six years and billions of dollars since we embarked on this journey and all we can come up with is some elusive “potential” that will certainly materialize if only we could spend a little more money, and if only we could drive a few more people out of this business, and only if we take the necessary next step, which we are told is to dismantle “the myriad socio-legal barriers to widespread health information exchange”, which is newspeak for removing any and all remaining privacy and informed consent protections for individuals, whether they like it or not. The truth is that we have no research, no proof and no reason to believe that the mythical “potential” even exists, let alone that the bigger-is-better, top-down model of health surveillance is best suited to unlock this “potential”.

I have to confess here that I have no idea what an open and interoperable EHR is. I also don’t know what a high usability EHR looks like. I do however know what a good EHR is, not a perfect one, but a good enough EHR. Just like any other piece of software, from Microsoft Office to Oracle Financials, a good EHR is one that people choose to purchase. If other people think there are better ways, then by all means, they should build amazing new software and fairly compete in the EHR market, instead of engaging in armchair quarterbacking of rules and regulations to advance theoretical concepts that captured neither market interest nor customer dollars on their own merit.

Quiz Question: Of the 5 stakeholders listed at the top, which one is absent, from all EXTREME use cases? Answer: The patient. Even in the tangential use case where data may be transmitted to a PHR, the patient is a passive entity, while the “organization” decides when, if and what to transmit. At some point, the few patient advocates who have not yet been thoroughly corrupted by the deluge of cash and fame, will have to come to terms with the grim realization that everything done and said nowadays is not intended to benefit the people, and health care is no longer an exception.

Thursday, June 4, 2015

How to Use CPT 99490 for Healing the Sick

The Medscape Physician Compensation Report puts primary care physicians at the bottom of the heap, with a median earning of less than $200,000 per year in 2014. What if the largest insurer of older Americans took those numbers to heart and decided to give primary care a pay raise of 25%, in recognition of and better support for the hard work involved in caring for the very old and the very sick? This is the general idea behind the brand new Chronic Care Management (CCM) fee introduced by Medicare on January 1st 2015. Three cheers for Medicare!

Unfortunately, Medicare structured its fees based on the now prevailing assumption that all doctors are charlatans, and hence every penny paid to them must be justified by at least one thousand pages of legal size, single spaced, dated and notarized documentation, or the electronic equivalent thereof. Furthermore, as is customary in our nation’s capital, every law or regulation that may be beneficial to the public, comes adorned with a wealth of gifts for special interests, which often render the original intent null and void for all practical purposes. The CCM is no different.

Medicare could have settled on a simple capitation fee for chronic care to provide payment for currently uncompensated care management and to expand such services to patients who can benefit from additional attention. By piling on reams of preconditions and micro-specifications, Medicare all but ensured that none of the money it plans to spend on CCM will actually benefit chronically ill patients. Complex regulatory frameworks benefit those who provide services to alleviate administrative complexity, in this case computer and software vendors, and garden variety consultants turned experts at chronic care management practically overnight. However, with a little bit of ingenuity, you can get and keep some of the CCM money, and with a bit more effort, actually use it to help the sick, if you are so inclined.

What you need to know

The first and most important thing you need to know is that if something sounds too good to be true, it usually is. The bogus CCM calculators you see on vendor websites, advertising that you can make a quarter million dollars per year in CCM fees are completely false, unless of course you are willing to fraudulently bill Medicare for CCM services, and even then, the projected revenues are overstated. Medicare will pay you approximately $40 per month for at least 20 minutes of non-face-to-face care management activities performed by clinical staff (including MAs) for patients with at least two severe chronic conditions. The fee is subject to standard copays and deductibles, and the service requires informed consent from the patient, above and beyond the general consent for treatment that you already have on file. CCM fees are for traditional Medicare patients only, and only if you bill under the Medicare Physician Fee Schedule (community health centers and rural health clinics are currently excluded).

Unless you are a geriatrician chances are that you will not have 491 traditional Medicare patients with two or more chronic conditions that “place the patient at significant risk of death, acute exacerbation, decompensation or functional decline”, and even if you do, many will be under the management of one or more specialists. Specialists can also bill for CCM, and only one physician can bill in any given month. From whatever number of patients you come up with, you should subtract those who will not consent to such nebulous service. Then you have to account for the copays you will not be able to collect, and the months when those presumably very sick individuals are discharged from a hospital, and you bill the much higher transitional care management (TCM) codes instead.

Bottom line is that if you get an extra $60,000 per year in Medicare CCM fees, you should consider yourself very lucky. To obtain this revenue, you will have to incur additional expenses. A good chunk of those expenses will be sunk costs if you are routinely managing your sickest patients pretty well. The added expenses involve mostly tracking time and billing, both of which can be optimized with a bit of Yankee ingenuity. You should be able to keep approximately $45,000 per year, if you have 150 consenting patients who fit the CCM requirements (or $300 per patient per year).

What you need to have

You need not attest to meaningful use, but you must have (and use) a meaningful use certified EHR. This is just a small gift to the tech industry. You must have a care plan for each patient that your staff (and your staff only) can access online at all times. You must provide these very sick patients with a way to access you or on-call staff (a person, not a machine) 24/7. You should have a reasonably accessible schedule for in person appointments, such as same-day availability. Although, Medicare does not specifically mention this, it would be very helpful if you were able to establish good channels of communications with hospitals, specialists, home-care agencies and long term care facilities. You will also need a good amount of patience and a sense of humor, but you will not need more expensive technology (e.g. population management, analytics, etc.).

What you need to do

I am certain that as you read this, you can come up with ten or twenty patients who fit the Medicare criteria, off the top of your head. That’s as good a place to start as any.
  1. Make a list of CCM candidates. Keep it small, particularly if you have minimal staff and if the patients are very sick. You could select by disease type, or better yet pick patients for whom you already provide significant amounts of uncompensated care between visits. Use this group as your pilot experiment.
  2. Schedule appointments with each one and obtain consent for CCM from as many as possible. Update, or formally create a care plan for each one. Hand them a copy (paper is fine), and place a copy in your Internet accessible EHR. Make sure that whoever takes call after hours has access to the EHR from home.
  3. Now comes the hard part. You need to track the time you or your staff spends interacting with each patient, or on behalf of each patient, each month (office visits excluded). You could simply use a paper timesheet, or you could find a way to use your EHR. Here is an idea that even the dumbest EHR can accommodate. Start a visit note for each patient on the 1st of each month. Leave it open and keep adding a brief note to it (including amount of time spent), each time you or your staff do something for the patient. Add the pertinent ICD codes and the CCM CPT and sign all the notes at the end of the month. Your biller can take it from there. Revise and tweak your process to make it as efficient as possible. This is why you should start small and grow the program over time.
  4. Twenty minutes is not a lot of time. One call with the patient (or caregiver) may just fill the entire allotted time. Other activities that are beneficial and can be counted are, talking to specialists, obtaining and reviewing consult notes and test results, arranging referrals, coordinating with home-care, reconciling medications and pretty much everything you usually do for these patients.
  5. Run your little pilot for a few months and see where it takes you. You have nothing to lose, and may end up pleasantly surprised.

What you should not do

Billing Medicare for CPT 99490 is cumbersome, but it is not as difficult as you are deliberately being led to believe. The Medicare CCM regulations were written in a way that allows, and encourages, outsourcing of services to third party vendors. The “market” responded with a wealth of fancy semiautomatic software products purporting to manage chronically ill patients remotely through interactive apps and “clinical” reviews of collected data. The going prices for these “services” are approximately what Medicare pays you, minus the copay, and you still have to do the actual billing. It’s a horrendously bad deal from a financial perspective, but it’s an even worse deal from an ethical perspective.

You should not outsource the management of your most complex and most vulnerable patients. You should not allow yourself to be used as a conduit for diverting Medicare funds to technology companies. Signing up a frail 85 year old gentleman with heart disease and Alzheimer’s for a monitored iPhone app, may meet the Medicare CCM regulations, but most certainly does not meet the clinical definition of care management. Chronic care management is not a $17 billion market. It is the ethical practice of continuous, comprehensive and compassionate medicine. If you outsource that, you might as well outsource your professional license and your very own soul.