Monday, December 8, 2014

JASON: The Great American Experiment

The distinguished JASON group of anonymous scientists and academics that provides consulting services to the U.S. government on matters of defense science and technology, just published a sequel to the 2013 best seller, “A Robust Health Data Infrastructure”. The new report is titled “Data for Individual Health”, and it has two purposes. The first and foremost purpose is to backtrack on the searing criticism leveled at government efforts to promote health information technology, which evoked much angst and indignation earlier this year. The second purpose is to expound upon the exact nature of personal data required to feed the robust infrastructure laid out in the first JASON report, complete with illustrations and examples of breakthrough benefits to humanity, such as helping city planners design bicycle paths. Yes, bicycle paths. And if you didn’t know that the number one health care problem in this country is the layout of bicycle paths, then you are a Luddite, and luckily your generation will soon be dead.

After dutifully observing that only a tiny percentage of Americans use medical services of any kind, JASON is informing us that the government agencies that funded its work “specifically” asked the group “to address how to bridge, on the national scale, to a system focused on health of individuals rather than care of individuals” [italics in the original]. It seems that the overdetermined triple aim of health care reform, better health for populations, better care for individuals, at lower per capita costs, is finally being reformulated into a solvable optimization problem by removing the unprofitable constraints on caring for the sick.

As was the case with the previous JASON report, the group was briefed by a diverse array of researchers and technology experts, including the great new hope of health, our most beloved, innovative, tax evading, and slave labor supported, Apple Inc. The content of briefing sessions is not available to mere mortals, but one in particular is rather enlightening in its title: “Disrupting the Status Quo: Putting Healthy People First”. Never since the dawn of medicine, from Hippocrates, to Florence Nightingale, to Mother Teresa and today’s Doctors Without Borders, have we experienced greater disruption in the status quo.

Similar to the first JASON report, the second offering is chockfull of technical recommendations for the “collection, assimilation, and exchange” of quantifiable “data streams” emanating from living things, whether in traditional medical surroundings or as people go about living their healthy lives. There is nothing earth shattering in the JASON findings or recommendations, but some finer points may be worth mentioning anyway.

Phenotypes - After providing us with a crash course in genomic sequencing and the workings of RNA and other protein molecules in the first report, JASON argued that the “biomedical research community will be a major consumer of data from an interoperable health data infrastructure”, hence the government “should solicit input from the biomedical research community to ensure that the health data infrastructure meets the needs of researchers”. In the second installment, JASON is reiterating its obviously very strong interest in genotype-phenotype relationships and their assimilation into the IT system they are recommending we build. Luckily, some of the JASON briefers happened to hail from academic centers renowned for grant funded genomic research in general, and efforts to “develop algorithms and methods to convert EHR data into meaningful phenotypes” in particular.

In Vivo - I have to admit that compared to run of the mill interoperability papers, which deal with unconscious patients in the ER, or people irritated by having to fill out paper forms, the JASON report is much more interesting. Here is another supercool futuristic development that we absolutely must consider when creating an IT infrastructure to collect data for health related research, which is essentially the main concern of the JASON group. It seems that the Defense Advanced Research Projects Agency (DARPA) is working on in vivo nanoplatforms. Something about “ultra-small scaffolds inserted directly into the body” and “fluorescent nanospheres that are functionalized to detect biomarkers of interest”. The purpose seems to be “continuous physiological monitoring for the warfighter”. We do of course want to support our troops, so these cute little nanites must also be part of our robust health data infrastructure.

FHIR - In this report JASON is taking an unequivocal stand behind a new HL7 standard for clinical information exchange, the Fast Healthcare Interoperability Resources (FHIR), which is actually pretty neat, and has been in development for approximately three years. FHIR is envisioned as a replacement for the C-CDA, which replaced the CCD, which replaced the CCR, which replaced an array of HL7 2.x messages. JASON is recommending that government “policies should make it advantageous for one or more leading EHR vendors to be the first to propose such standards”. Lo and behold, two days after the JASON report was published, a group of leading vendors and institutions, several of which briefed JASON, and some who are helping the government implement JASON’s recommendation, launched the Argonaut Project for precisely this “advantageous” purpose.

FDA - For some reason the JASON report is engaging in a lengthy and strangely passionate litigation of the 23andMe (a DNA analysis service) tiff with the Food and Drug Administration (FDA) from a year or so ago, concluding with a recommendation that the FDA should take a “more nuanced approach” to its regulation of apps that could be construed as “practicing medicine”. The FDA regulatory authority over medical software has been in the crosshairs of corporate lobbyists (tech, pharma, telecom, etc.) for a couple of years now, with a variety of bipartisan deregulation bills introduced, or almost introduced, unsuccessfully in Congress. Coincidentally, two days after the publication of the JASON report, Senators Bennet (D-CO) and Hatch (R-UT) introduced the MEDTECH Act, the most serious attempt so far to restrain the FDA’s regulatory abilities.  

Non-profits – JASON is recommending that non-profit organizations, either those that are disease specific or general in nature, “should be encouraged to assess their goals with respect to health data streams, and to provide “stamps of approval” for applications (apps) and other consumer tools”. In other words non-profit organizations should leverage the trust of their communities to monetize their members’ health data. JASON also recommends that private foundations should help the government by creating cash prizes to entice entire communities into participation in data wellness games. This is brilliant thinking, which leads me to hypothesize that at least one of the JASON members must be a Nobel laureate in marketing.

In this era of “transparency”, where every dollar from every pharmaceutical company or government agency, paid to every doctor and hospital, comes under relentless public scrutiny, why should JASON be exempt? Shouldn’t the JASON reports be accompanied by full disclosures of conflict of interest, both for JASON members and the various briefers whose pet projects populate every page of every report? Where is the media when a group of secretive researchers and private corporations are steering almost 20% of our economy towards endeavors immediately beneficial first and foremost to themselves?

When you read the JASON reports back to back, you are left with the impression that the group’s overarching goal is to create an international distributed repository of genetic materials tied to individual, environmental, behavioral and disease specific manifestations for all people on this planet. There is no doubt in my mind that a structure of this type and magnitude can facilitate an infinite number of perhaps beneficial research projects, and maybe even an IPO here and there. But if taxpayers are expected to fund the infrastructure for such expansive research, shouldn’t they be asked, or at the very least clearly informed?

And why rob the President of the United States of a legacy-defining “We choose to go to the moon” speech? It could go something like this: My fellow Americans, by 2025 every American will have his or her DNA collected and catalogued, and by 2025 every movement and every breath of every American man woman and child will be associated with their genomic sample, launching the grandest experiment in the history of mankind. From the ashes of the Great American Experiment, we will bring you more than freedom, more than liberty and more than a futile pursuit of happiness. We will bring you, Health. Download it for free from iTunes today.

In 1802, Thomas Jefferson wrote in a letter to David Hall: “We have no interests nor passions different from those of our fellow citizens. We have the same object: the success of representative government. Nor are we acting for ourselves alone, but for the whole human race. The event of our experiment is to show whether man can be trusted with self-government. The eyes of suffering humanity are fixed on us with anxiety as their only hope, and on such a theatre, for such a cause, we must suppress all smaller passions and local considerations.” Whatever.

Monday, November 24, 2014

Teachable Moments: Be Thankful for Gruber

So there is this guy from MIT or Harvard, or some other place where they teach our leaders how to lead, and his name is Jonathan Gruber. Mr. Gruber, it seems, was hired to consult with the Obama administration during the time the Affordable Care Act (ACA) was created because of his extensive expertise in designing the Massachusetts health care system. In recent weeks, people who don’t particularly like our President, and his Obamacare health insurance reform, began floating video snippets of Mr. Gruber publicly discussing the stupidity of the American electorate and the purposeful lack of transparency that in his learned opinion enabled the enactment of the ACA.

The rightwing conservative media savored their “I told you so” moment with great gusto. The leftwing media immediately rose to the occasion reiterating the litany of Obamacare benefits, which should not be forgotten just because this one guy said that we are all idiots. Mr. Gruber himself expressed “regret” for his “off the cuff” remarks. Perhaps they don’t teach linguistics at MIT, but “off the cuff” is not a synonym for erroneous. David Axelrod declared on Twitter that Mr. Gruber is the one who is stupid and the White House assured us that nobody there shares Mr. Gruber’s opinions. Some Congressional leaders, seemingly afflicted by the Iran-Contra syndrome, couldn’t remember who Mr. Gruber was, while others decided to bring Mr. Gruber in for questioning. Reality TV doesn’t get much better than this.

But what if Mr. Gruber is right? What if we are stupid? Not each and single one of us, and not all day, every day, but every two years or so when we come together to form the American electorate. Here is a dirty little public secret: many of us share Mr. Gruber’s opinion, albeit in a more eclectic format, and many of us have no problem publicly broadcasting our views. Liberals believe conservatives are too stupid to understand that Medicare is a Government run program, too stupid to understand scientific concepts, and stupid enough to go to war over imaginary threats. Conservatives believe liberals are too stupid to understand the Constitution, too stupid to grasp the basic concepts of freedom & liberty, and stupid enough to hand over our democracy to a fascist communist Islamic emperor on a platinum fundraising event platter.

Perhaps instead of gleefully watching the Gruber spectacle, we would be better served by trying to figure out why our collective actions look stupid when viewed from the elevated vistas of our rarefied intelligentsia. Using health care reform as an example, although there are many more equally instructive subjects, here are a couple of recent teachable moments that could explain our tarnished image.

California Proposition 45

On November 4th, California voters “soundly rejected” a proposition “that would have halted excessive health care insurance rates”. It seems that California voters like paying excessive prices for their health insurance, and if you like your excessive prices, you should be able to keep them. Alternatively, one could be tempted to surmise that California voters are too stupid to understand what they are voting for. Earlier this year, Californians expressed massive support for Proposition 45. Between then and Election Day a $43 million media blitz, financed mostly by insurance companies, descended upon California to convince voters that allowing health insurance corporations to steal their money, unencumbered by public regulations, is a good thing. It worked.

It may be worth mentioning that the non-profit Kaiser Permanente poured almost $15 million of its tax exempt revenues into defeating Proposition 45. Back in 2009, while the Affordable Care Act was being shaped, President Obama held out Kaiser Permanente as “one of the models of high-quality, cost-efficient care” that “would have solved our problems”, based on the experience of his grandmother in Hawaii. We may need to broaden the usage of epithets beyond the plebeian electorate.

But the one thing that breaks my heart in the Proposition 45 surreal, yet typical, chain of events is that almost without exception, California medical associations chose to align with and actively support the insurance industry. The same insurance industry that is treating doctors like commodities, firing them from networks at will, and is routinely robbing them of professional autonomy. TV commercials featuring real physicians, sporting white coats and stethoscopes, abusing their trusted relationships, reciting outlandish prophecies that no one can verify, littered the public airwaves in California this fall. Practically every organization whose members are paid with health care dollars threw its support behind this willfully deceptive campaign to defraud the people of California.

Insider Trading

Back at the start of 2013, the Centers for Medicare and Medicaid Services (CMS) indicated that payments to Medicare Advantage plans are “likely to decline by 2.3 percent in 2014”. On April 1st of 2013, CMS reversed its decision and released final Medicare Advantage rates for 2014 that showed an increase in payments following a “change in methodology”. Turns out that a Congressional staffer provided information to a lobbyist, who passed it on to an analyst, triggering a buying spree of health insurance stocks prior to the CMS announcement and lots of rich people got richer. The New York Times dutifully published an article in its business section outlining the insider trading investigation recently initiated by the Securities and Exchange Commission for this event.

Leaving this particular outrage aside, one might wonder about the nature of this “change in methodology” that triggered an increase in Medicare Advantage payments. Did the CMS revise its calculations? Did the original figures contain arithmetic errors? As it turns out, this is not about math. An email from the lobbyist to the analyst indicates that rates were changed because “a deal has been hatched to increase Medicare Advantage rates in order to smooth the confirmation of Marilyn Tavenner as the new head of Medicare”.

Unlike her predecessor, Dr. Donald Berwick, who is a staunch liberal with a long record of public statements to that effect, Ms. Tavenner was an uncontroversial appointee, with no political (or any other) damning baggage, and as such enjoyed the support of large swaths of the industry, as well as powerful Republican officials, such as Sen. Chuck Grassley and Rep. Eric Cantor. But that was hardly enough. It seems that today in America, the lawfully elected President of the United States, and the lawfully elected Congress, in order to perform the most mundane functions of their respective offices, must first grease the palms of health insurance companies. And the saddest part is that neither The New York Times, nor any other media outlet, thought this to be newsworthy.

Other Grubers

Mr. Gruber is just the latest public figure to express regret for being caught. Back in 2012, Gov. Romney had to stage a tortured apology for calling half the country irresponsible bums. Last year, the powerful Director of National Intelligence James Clapper, apologized for blatantly and intentionally lying to Congress about covert surveillance of most Americans. Just a few days ago, Uber’s CEO Travis Kalanick, staged a ridiculous Twitter apology for explicit threats to unfriendly journalists made by another Uber executive behind closed doors. Facebook apologized for experimenting on its users and Google constantly apologizes for snooping around without permission. We now have an entitled class that regrets only the inconvenience of having its business and opinions exposed, and subsequently used by their opponents in the power games played by the rich and famous.

Mr. Gruber rightfully did not apologize for his remarks, because they were authentic and truthful as most “off the cuff” utterances are. From the vantage point of our elected government and its diverse assortment of greedy consultants, the American electorate must indeed look pretty stupid. And from the higher perches of billionaires and corporate interests, both American voters, and their seemingly elected officials, must appear as the sheer embodiment of laughable stupidity. Instead of reflexively shooting the unsavory messenger, perhaps we should thank him for the heads up, look at ourselves in the mirrors held by great power and great wealth, and take stock of what we have become as a nation. We can do this, precisely because in spite of acting like a bunch of idiots lately, we are not, and never have been, stupid.

Tuesday, November 18, 2014

Quick Medicine

By the time the next decade rolls in there will be no paper charts. There will probably still be paper floating around in various capacities, but there will be no one charting on paper. The term “charting” itself may become obsolete, like yonder or popinjay. The term EHR, which is what replaces the paper chart, won’t last either because it doesn’t roll easily off the tongue like say, email instead of letter or missive. EHRs don’t do anything else easily, so chances are EHRs themselves won’t last much longer, relatively speaking. Sooner or later, the national spotlight will shift to something other than health care, and other electronic critters will emerge from the shadows.  What will they be? What should they be? Those could be two very different answers.

What Should Be

Have you noticed how people advocating for EHRs use the word quickly in practically every sentence? Mega EHR allows you to quickly document XYZ, and Super EHR can quickly gather all historical data and display it in a summary dashboard which allows you to quickly assess the status of the patient. You can quickly send prescriptions to pharmacies, quickly order a bunch of tests, and quickly print out (the horror!) education materials. Your staff can quickly schedule patients, quickly answer questions, quickly verify eligibility and quickly drop claims. Your patients can quickly get answers, quickly schedule visits and quickly have their concerns resolved.

Of course, most of these things are aspirational at this point, but the language is indicative of the thought process behind EHR design: hurry up and get it over with. Time is money and quickly disposing of each patient is absolutely imperative in a high functioning health system. You could argue that there is nothing wrong with speeding up, or even eliminating, administrative tasks, and you would be right. But is reviewing historical information on a patient and documenting today’s encounter an administrative task? When reviewing histories is compressed into briefly glancing at a bunch of sparklines like they have for the stock market, it may seem like you are engaging in an administrative task. Buried somewhere deep in the dark chart though, there may be a note you made about Mary’s difficulties to navigate the front porch stairs last year.

Why did you make that old note? It’s not required for billing. It’s not demanded by insurers. What made you type that in? Do you usually make notes about irrelevant things that you fully expect to never see again? When you used paper charts, you had to flip through many pages to gather the information you can now quickly glean from your infographic patient dashboard. And while you were paging back and forth through that chart, chances are you would have stumbled upon that little note that seemed important enough for you to scribble down last year. And maybe you would discover other little notes too.

Is reading a book the same as reading the SparkNotes? Oh, you will pass the test either way, and may even get better scores with the SparkNotes version, but is it the same? Is reading this: “Ultimately, he is unable to bear the psychic consequences of his atrocities”, the same as reading this: “Tomorrow, and tomorrow, and tomorrow, /Creeps in this petty pace from day to day, /To the last syllable of recorded time; /And all our yesterdays have lighted fools /The way to dusty death. Out, out, brief candle! /Life's but a walking shadow, a poor player, /That struts and frets his hour upon the stage, /And then is heard no more. It is a tale /Told by an idiot, full of sound and fury, /Signifying nothing.”? Which version leaves you better equipped to address the story at hand, and the story-teller himself as a whole person? And which version makes you, the reader, feel more like a whole person?

Whatever else the EHR of the future might do, it should quit trying to quantify, summarize, highlight and decontextualize the soul out of the medical record. Disposing of patients quickly should not be our goal. Other than being demeaning and dehumanizing for all involved, seeing patients quickly is the root of all our health care woes. In an environment increasingly hostile to human interaction, EHRs should ferociously fight to create more time for patients to spend with their doctors. EHRs should automate the business of medicine and eventually the science of medicine, while protecting the art of medicine. And by art, I don’t mean compassion and advocacy. I mean the application of professional judgment, without which the science is incomplete and will always be incomplete, regardless of how many genes we can map or how many bots we can implant in ourselves.

Assuming that the business of health care will be marching along the glorious path currently laid out by our betters, the EHR of the future should endeavor to become a silent background processing machine. Natural language processing should be the first and foremost feature to be implemented to perfection. The EHR should parse and extract useful information from doctor-patient interactions to maximize physician reimbursement by maximizing claim values (yep, I just said that), and by scouring all opportunities to obtain incentives and bonuses from the overlords, and automatically applying for all, without user intervention. Not an easy task, but IBM Watson could drop out of medical school and take this on.

The flip side of maximizing revenue is to cut overhead. No practice needs a scheduler. Let patients schedule themselves online or on the phone. Let them check in and let them room themselves (think about those little restaurant gizmos that beep when your table is ready). Let them take their own vitals and answer all those preliminary questions on their own. For the outliers, the frail and the elderly, one medical assistant can cover these tasks for bigger practices. It doesn’t sound much like an EHR because it isn’t.

What else costs money, but has practically nothing to do with medicine? All the school notes, the back to work notes, the disability forms, trade forms and all other forms, authorizations, pre-authorizations, eligibility checks, statements and everything in between, can be delegated to computerized self-service. Get the medical records online and let patients have at it. Make it user friendly like all other trivial consumer facing apps that have absolutely no bearing on enterprise technologies. Make them colorful and fun. Show pictures, animations and ads. Put them on the iPhone. Monetize the heck out of everything, and remove this purely administrative burden from the practice.

And then comes a moment when restraint needs to be religiously exercised. Stay the heck away from the exam room. Let people say whatever they want to say. Let doctors ask whatever they want to ask. Forget about boxes, no matter how useful they look. Forget about structure too, because Watson will be taking care of that. Don’t make documentation easy, because taking notes is not just about documentation. It is mostly about the background thought process that makes one decide what to note and what to discard. Remember, the way you would use different styles of handwriting and text of different sizes or boldness, and how you added critical notes in the margins, or big pointy arrows? Actively taking notes helps you synthesize information, internalize, memorize and understand the narrative (programmers, think back to your college days).

If EHRs want to be helpful, let them be secretaries. Arrange the notes in a way conducive to better information retrieval. Don’t summarize and don’t impose your (or your machine’s) notions of what is or is not important. Collate and bind everything into a patient book. Remember that this is a reference book and the user can read at a 30th grade level. It is not a cookbook and it is certainly not a picture book. Add a table of contents. Use the computer to make it dynamic. Make it easy to flip pages in an electronic context. Make the fonts nice and large, and do learn from beautifully maintained old paper charts. Go out and look at some before they are extinct. You can’t improve that which you don’t know.

What Will Be

Of course none of the above is going to materialize in a meaningful way, except maybe the infantilized consumer facing EHR. Health care is going retail and health care will care about its customers precisely as much as Walmart and Amazon do. And health care will care for its employees as much as Walmart and Amazon do. When providers are all transitioned to having their employer paid for value, EHRs will become very easy to use. A few big buttons, at the bottom of pages prefilled with stereotypes and sprinkled with colored sparklines, should quickly do the job (i.e. Order, Refer, or Deny). There will be nothing for you to document and nothing for the patient to convey because the system already knows everything there is to know. Eventually, it will dispense with the buttons altogether, and your job will be to quickly explain to your customer why the system did what it did. And you will never have to use a computer ever again. Mission quickly accomplished.

Monday, November 10, 2014

Technology for Onesies Twosies

“We’re not really set up to service onesies twosies… Oh, I’d say at least fifty to even begin a conversation… There’s no money there, and support is a nightmare. You know what I mean… Besides, there aren’t many left anyway…”

According to the American Medical Association, there were approximately 685,000 physicians in patient care, post-residency, not employed by the federal government, in 2012. 60% of these physicians practiced in independent private practice, and 84% were working in small to medium size practices. Assuming that the trend to employment of doctors by health systems continued unabated to this day, over half of practicing physicians are still in private practice and the overwhelming majority is working in small to medium practices. Let’s pause, and allow this simple fact to sink in.

When it comes to EHRs and health IT in general, you are the omnipotent consumer. Unfortunately, the best and brightest seem to consume just like the worst and dumbest do. Would you buy 10 magazines for a chance in hell to “win” $100 million? Would you open a bank account if I give you “free” checking? Would you use my credit card if I give you 1 cent back on each purchase? Would you click this shiny button if I let you use my “free” software? And what would you do for a Klondike bar?

Case in point: Meaningful Use is a voluntary program. The maximum incentive per Medicare physician is equivalent to seeing one more patient per week. The maximum penalty for a typical Medicare physician can be recuperated by seeing one more patient per week. The cost of using a Meaningful Use EHR, in both cash and physician time, far exceeds one weekly visit. Can someone please enlighten me on why there is no market (and trust me, there isn’t) for non-government sanctioned technology that is purposely built to serve doctors? Remember, you own more than half the market.

After swallowing Meaningful Use, hook, line and sinker, here comes desert. The goal of Meaningful Use was to collect enough information about your patients, so you, and every Silicon Valley funded techie, can process the health of large populations in bulk. As any United States Postal Office clerk can tell you, bulk processing of things is much cheaper than first class processing of the same, but bulk processing requires specialized machinery beyond the simple collection of items to be processed. The bottom line is that in order to stay competitive you will have to buy more technology. In light of your previous shopping history, we know exactly what’s going to transpire. You will buy whatever junk the government subsidizes. And you will use it in the prescribed manner, while complaining that it is taking the joy out of medicine, the quality out of patient care and the profit out of your practice.

You will be using your EHR to dutifully collect the meaningful dataset each time a patient walks through your door. Your interoperable EHR will then feed the data to a population management software product, which processes the data to yield such insights as the exact size of the diabetic population in your practice, tagged with the exact levels of Hemoglobin A1c results for each item. The artificial intelligence embedded in the population management software then performs some very complex analytic tasks, which are beyond the capacity of the human brain, to highlight the items outside normal parameters (e.g. A1c > 9), and very advanced analytic software may even suggest that these outlier sub-populations need additional management (e.g. behavior modification to eat less candy).

But wait, there is more. Population management machines can actually predict the future of mankind, one man at a time. The superhuman intelligence embedded in these software products can take advantage of massive genomic data and situational data to predict the future health of any given person, which is something that a mere country doctor could never, ever accomplish by his lonesome self. For example, you can be alerted in real time that the 30 year old guy with a recorded BP of 140/100, who is 50 lb overweight, smokes a pack of cigarettes per day, works in a call center 10 hours every day, and whose hobbies consist of watching reality TV and playing video games, will be developing some very expensive diseases in the future, and you’d better do something about that. 

This is truly amazing stuff, but sadly these exquisitely useful population management machines are also exquisitely expensive. The global market for population processing products is projected to reach $40.6 billion within the next three years (probably a gross underestimation), and there is no assurance that you will be included in this booming market, because without government assistance, selling technology to onesies, twosies is like herding cats for no reason. Onesies, twosies is a term of endearment in the industry for small independent practices that find it difficult to part with their money, and where physicians are obsessed with “seeing patients”, instead of schmoozing with disruptive innovators. Luckily, and right on cue, the government is jumping in to lend a helping hand.

For the already tech savvy, but cash poor private practice, CMS is now offering to pay upfront for your technology investments, if you agree to assume risk for the health and happiness of your populations. You would have to band together with other likeminded practices to form an Accountable Care Organization, and CMS will in turn advance you enough cash to pay for population processing infrastructure. You pay CMS back with several years of hard labor to reduce expenditures for your population. If you fail to save CMS money, or if you decide to walk away, you will have to return the entire cash investment to CMS. Your technology vendor is not likely to be encumbered by such medieval arrangements.

For the laggards and procrastinators, starting on January 1st 2015, the Medicare physician fee schedule will include a new CPT code for Chronic Care Management (CCM) that will pay you $42 per month, to provide 20 minutes of non-face-to-face services to people with two or more chronic conditions who agree to pay $8 copays for the privilege. After decades of silent complicity in the destruction of primary care, Medicare is placing a significant amount of money on the table for you, with the understanding that this too requires certified EHRs and a roadmap to population management infrastructure that will enable you to eventually assume risk for your empowered patients.

Disruptive innovation, according to the grand priest of innovation, Prof. Clayton Christensen, “is a technology that brings a much more affordable product or service that is much simpler to use into a market. And so it allows a whole new population of consumers to afford to own and have the skill to use a product or service, whereas historically, the ability to access was limited to people who have a lot of money or a lot of skill”. This definition does not seem to fit the, taxpayer funded, successive layering of complex and increasingly expensive big iron technology products, on an already unaffordable industry sector. A more modern interpretation of Prof. Christensen’s definition seems to be in order.

Let’s define consumers to be health insurance companies, and in their world affordability means profitability. The products are the covered lives and the services are your labor. Now we have a technology that brings much more profitable covered lives and medical services that are much simpler to manage for health insurance companies. And so it allows a whole new breed of insurance plans to profitably enroll covered lives and have the skills to manage physician labor, whereas historically, the ability to do so was limited to insurers with particularly savvy business models and a lot of manipulative skills. Here is your disruptive innovation. The end game of course is to remove actuarial risk from health insurance stakeholders and transfer it all to you.

Theoretically, you, and all other onesies twosies, or even twenties and fifties, who form the (still) independent majority, could stand up and stop the madness. Theoretically.

Tuesday, October 28, 2014

Public APIs: The Ultimate Silver Bomb

Congratulations! We have a new buzzword trending in health care IT - Public APIs.  You can say public APIs everywhere you used to say interoperability. You can also replace the very unprofessional “EHRs can’t talk to each other” with “EHRs lack public APIs”. People will nod in solemn agreement, and you will sound very informed and up to date on the latest developments, but just in case you encounter the quintessential child inquiring about the king’s rather scant wardrobe, here is a little background information.

(Very) Brief Introduction to Public APIs

API stands for application programming interface. Yes, interface, like the ones you have with your claims clearinghouse or your lab service provider or pharmacies. There are several ways to classify APIs, but for our discussion, we only need to consider two types of APIs: data APIs and services APIs. Data APIs are the simplest, and go something like this: software A sends a request for information to software B, and software B sends back the required information. Another way is for software A to send unsolicited, but previously agreed upon, information to software B, which will then send back a brief thank you note to software A.

For this exchange to work well, both software A and software B need to agree on a communication protocol and both should share a common understanding of the data. This common understanding of data is called a standard. Standards usually emerge from non-profit organizations dedicated to defining such standards, so for example, your claims interface uses something called ANSI X12 as its exchange standard, your lab interface uses the HL7 standard and your pharmacy interface uses something called NCPDP Script. Turns out you’ve been using APIs all along…

Service APIs are less common in health care, although if you look at the big picture, you could say that claims clearinghouses, labs and electronic prescribing are all really services. A simple example of a pure service API, where software A invokes a piece of code executed by software B, is a warfarin dosing calculator. Here software A sends a few agreed upon parameters (i.e. demographics, diagnosis, medications, INR, genomics, etc.) to software B. Software B performs a highly specialized calculation using those parameters and sends the result back to software A.

APIs are deemed to be public, or open, if the specifications are publicly available on the Internet for anyone to use. Health care APIs are not usually public, and formal business relationships need to be established before any one software developer can use another’s APIs. Google Maps APIs, for example, are said to be public, and so are MapQuest APIs. Note however, that although both serve basically the same purpose, they are not identical or interchangeable, and they are not validated or certified by a public agency. Both Google and MapQuest publish APIs to their mapping software, because it makes business sense for Google and MapQuest to do so.

Why Now?

JASON (as in Jason and the Argonauts) “is an independent scientific advisory group that provides consulting services to the U.S. government on matters of defense science and technology”. JASON was established in 1960 and it “has conducted studies under contract to the Department of Defense (frequently DARPA and the U.S. Navy), the Department of Energy, the U.S. Intelligence Community, and the FBI. Approximately half of the resulting JASON reports are unclassified.” The latest unclassified JASON report, A Robust Health Data Infrastructure, was commissioned by the Department of Health and Human Services (HHS) “to address the nationally significant challenge of developing comprehensive clinical datasets, collected in real world environments and accessible in real time, to support clinical research and to address public health concerns. These datasets could be used to guide clinical research, enhance medical decision-making, and respond quickly to public health challenges.”

The identity of JASON group members is secret, but rumor has it that these are some of the best and brightest scientists in the country and have over the years included several Nobel Prize winners. Although we don’t know who JASON is (or are, or however one refers to an anonymously unaccountable group of advisers), we should note that JASON was introduced to the subject by 18 expert briefers (8 from research and academia, 2 from Microsoft, 2 from IBM, 1 videogames developer, 1 from HIMSS, 1 from Deloitte, 1 from Kaiser, 1 from the White House and 1 from NQF). These representatives of medicine in America guided JASON to useful materials about information technology in health care, and actively participated in subsequent JASON discussions.

Similar to a report put forward by the President’s Council of Advisors on Science and Technology (PCAST) four years ago, JASON recommends that massive amounts of clinical data be collected at the point of care in a format suitable for extraction and combination with non-clinical data, to facilitate large scale “biomedical” research. To that end, HHS should actively engage in the creation of a national clinical data exchange architecture, based on nationally enforced standards and public APIs implementing those standards, and it should engage in these activities immediately and with the full force of a government agency. All the work done to date by HHS and its various initiatives resulted in inadequate proliferation of legacy health IT systems, which should be replaced now, and the aggressive migration path suggested by JASON begins with using those public APIs to extract and reformat clinical data from the vast repositories of legacy systems.

To date, HHS has spent over $25 billion of taxpayer money on partially reimbursing hospitals and physicians for the purchase of health IT systems. The much larger remaining costs of buying, implementing and using these systems is unknown. According to the CMS data, there are close to half a million clinicians and almost five thousand hospitals registered to participate in the Meaningful Use program, all using certified EHRs. Practically all these legacy EHRs have found ways to routinely exchange billing information, medications information, laboratory and imaging information, and more recently, referral information, immunizations information, generic messaging and a host of other document based notifications. This may be a great start for patient care delivered by people who can read, but it is totally and completely unacceptable for global biomedical research.

Faced with distinguished panels of scientists and technology experts stating that medical care is basically a gigantic experimental research project, and a government thoroughly convinced that peace, prosperity and good health are a direct function of the amount of information collected about each and single one of us, what should we do next? Should we immediately start ripping and replacing the brand new legacy systems in use by 80% to 90% of doctors and hospitals, because more powerful vendors would also like to make money in health care? Or should we take a subtler approach and slap a host of new regulations on legacy vendors forcing them to build and maintain a public API infrastructure to benefit all newcomers? After vigorously protesting the JASON findings, the government seems to have chosen the latter.

As Microsoft, IBM, Apple, Google, Facebook, Verizon, Salesforce (I kid you not), and everybody with a registered web address, join the health care feast, you should expect more colorful user interfaces, with interminable scrolling screens filled with extra-large fonts, big flat smoky colored buttons, eye-popping images and practically no functionality, as is fashionable in consumer websites. Most of this “software” will be geared towards your patients, the ultimate generators of marketable biomedical research data. Your current EHR vendor will be exhausting all its resources on creating, maintaining, testing, certifying and publishing mostly data APIs, but in the short term also services APIs, to pave the road for giant technology aggregators and tiny app builders.

If your certified EHR vendor is small to medium in size, expect it to fail and go bankrupt in the next few years. If your EHR vendor is large, expect it to be acquired and decimated by a global corporation. Barring a miracle, the passive-aggressive grumbling of physicians will finally subside, and the march to defragmentation of our “broken”, “stove-piped”, “siloed”, “walled-garden” system (a.k.a. competitive, free-market, let the best man win, type of system), will continue at a brisk pace.

For better or worse, we need to recognize that in this country health care is a business, a very large and profitable business. Perhaps it shouldn’t be, but it is. Health care is being told day in and day out that it should learn from other industries. Well then, how would the banking industry react to a requirement to create public APIs allowing wholesale extraction of fully identified transactional data of their customers and all the communications conducted around such transactions between the banks and their clients? What would be the response of airlines, car manufacturers, restaurants, or even Google and Apple, if the government demanded that they invest in infrastructure solely intended to help other companies put them out of business? Take a wild guess...

Monday, October 6, 2014

How Health Care Went Tabloid

Physicians, whether practicing medicine or not, should not be involved in clinical research. They should never be consulted on development of new drugs and medical devices. Doctors should not invent new treatments, and should never supervise clinical trials. They should not travel to or speak at conferences either, and they should banish all entrepreneurial notions out of their heads. If they insist on engaging in these activities, they should do it all for free, out of the goodness of their Hippocratic heart. A medical degree should immediately disqualify you from making money in the health care industry, which is a privilege reserved for technocrats, business executives and garden variety ex-political appointees.

Matt Bai, a veteran political journalist, wrote a new book titled “All The Truth Is Out: The Week Politics Went Tabloid”, where he is attempting to pinpoint the demise of serious political journalism to the Gary Hart scandal of 1987. If you recall, Mr. Hart, the all but certain Democratic candidate for President of the United States at that time, was railroaded out of politics by a romantic dalliance with, of all people, a very pretty pharmaceutical saleswoman. Matt Bai goes on to assert that since the Gary Hart affair “the entire ethos of political journalism has really changed. Because all the attention, all the kudos, is in taking someone down, is in finding hypocrisy”. Political journalism is arguably the heart of journalism, and as the heart goes, so goes the lesser journalistic body, health care reporting included.

This week, the CMS released a new "trove" of information about payments made by pharmaceutical companies and medical devices manufacturers to physicians and hospitals. The dataset includes millions of records ranging from payments of $0.00 (?) to millions of dollars. Some of the records specify the recipient while others do not, and most list the reason for payment. The data is preliminary at best and lots of cleanup activities are to be expected, since various recipients of funds have discovered errors large and small. A database like this one could eventually be useful for example for cross checking disclosures for published papers and education materials, or for people who are studying the financials of life science sectors of the economy. As expected though, the health care media saw things differently, because these data present ample opportunity to find hypocrisy and take someone down.

To put things in perspective, here is a brief summary of the data from an angle nobody saw fit to print. Below is a breakdown of amounts received by named physicians for the largest category of general payments, which includes food, travel, honoraria, consulting, royalties, licensing fees, and a host of other frivolous activities. In addition to this dataset, there are two smaller sets, one for research payments and one for ownership, or equity, in life science companies. And then there are three parallel datasets where the CMS decided to withhold the names of recipients due to uncertainties regarding data validity. We will disregard the list of payments made to unidentified entities, and concentrate on the largest dataset of payments to doctors. There are 358,686 named physicians in this dataset, and this is how total payments are distributed.

It looks like the median payment value is approximately $100, and 9 out of 10 docs who received anything, received less than $1,000 worth of goods, services and sometimes even cash. The big money went to a fraction of a percent at the top, mostly for royalties and licensing of things they designed or invented. I randomly picked a couple of these folks and looked them up on Google. The first one turned out to be a world famous vascular surgeon who invented multiple devices to fix aneurysms, pioneered various types of surgeries, and even got himself a Medal from the Society for Vascular Surgery. The second fellow is an orthopedic surgeon, also world famous who specializes in acute trauma and posttraumatic reconstruction of feet and ankles, and is the inventor of all sorts of plating and nailing systems for his specialty. He has more credentials than you can count and some very prestigious awards to go with that. At this point I stopped searching.

Now let’s look at how the New York Times reported this data release. The first article came one day before the data was published, giving us a heads up on the impending release, educating us on already existing resources, such as the subtly titled Dollars for Docs database, and plainly stating that “most physicians that are in private practice are touched in some way” by the industry. Yes, only private practice docs are “touched” by the scourge. The next article was just a kneejerk litany of complaints about the CMS database functionality, which by the way, I found to be surprisingly nice.

The third New York Times article was cleverly titled “Detailing Financial Links of Doctors and Drug Makers”, a title as innocent as the 1987 Miami Herald story “Miami woman is linked to Hart”. Linkage implies secretive impropriety about to be exposed. You don’t often see headlines saying “Fireman linked to saving baby from burning building”. The article itself is fraught with equally innocent language such as “doctors reaping over half a million dollars each”, “murky financial ties between physicians and the health care industry”, “lucrative arrangements are just some of the findings”, and in a surreal tale of the doomed, a righteous Cleveland Clinic physician is contesting his own listing because “he had spoken at the event but deliberately skipped the lunch”.

The most recent New York Times article is titled “Financial Ties Between Doctors and Health Care Firms Are Detailed”, just in case you missed the “detailing” pun the first time around. This article opens with a series of dramatic one sentence paragraphs. “For some doctors, treating patients isn’t the only way to make money”. You can pretty much hear the thriller music in your head. “A Michigan plastic surgeon was paid more than $300,000 to travel the world teaching doctors about new cosmetic products like a breast implant”. Impropriety is best served with female body parts. “The retired chief executive of the Mayo Clinic, who once helped write its conflict of interest policy, received more than $237,000 in compensation for serving on multiple corporate boards”. Wow, a retired doctor sits on corporate boards. Even the venerable Mayo Clinic has no ethics.

Following the boilerplate “murky financial ties between physicians and the health care industry”, we are informed that “the typical doctor earned only about $1,750 from August to December 2013”. Actually, the “typical” doctor barely eked out a hundred bucks worth of crappy conference food, unless he or she skipped lunch altogether, or maybe just refused the fake ├ęclairs at the end, but math is a very flexible thing.  And on and on goes the litany of naming names, like a bad Seinfeld take on the McCarthy era.

The rationale for this abject witch hunt is that physicians who ingest pharmaceutically sponsored food are likely to return the favor and prescribe expensive brand name drugs instead of cheap generics. According to an IMS report from April 2014, generic medicines are now representing 86% of prescriptions, and have been steadily increasing over recent years. I seriously doubt that the numbers can get much better, and either way during these days of high deductibles and narrow formularies, doctors are rarely at liberty to prescribe brand name drugs when generics are available. Not to mention that as physicians are increasingly losing their independence, pharmaceutical companies are turning their efforts to hospitals, which are much better at financial wheeling and dealing. And yet, all the headlines and all the articles are about doctors, because taking down a person with a name and a face, using innuendos and baseless allegations, is so much easier than picking on a lawyered up corporation, and it is equally fulfilling, it seems.

Monday, September 29, 2014

Are You an Information Blocker?

The Senate Appropriations Committee has defined a new transgression perpetrated in the committee’s expert opinion by vendors of certified EHRs, as well as “eligible hospitals or providers”. Since the committee has no data or evidence of any kind that this transgression is actually occurring, it requires the Office of the National Coordinator for Health Information Technology (ONC) to embark on a fishing expedition to locate all perpetrators of “information blocking” and devise a “comprehensive strategy on how to address the information blocking issue”. The committee is recommending that “ONC should take steps to decertify products that proactively block the sharing of information”. The Senate committee does not specify which information should be shared, but it unequivocally states that information blocking practices “frustrate congressional intent”.

Interoperability is the means by which computers communicate with each other. It is not necessarily the means by which people use computers to communicate. Lack of interoperability does not mean that patients cannot access their medical records, and it does not imply that physicians are unable to obtain pertinent information at the point of care. Interoperability means that communications between human beings are mediated by a computer that has the ability to parse, process, combine and use exchanged information in multiple ways. It therefore means that the information is formatted as structured and universally standardized atomic elements, translatable into identical 0 and 1 bits of electric current by all computers. Talking on the phone, faxing pieces of paper, exchanging electronic messages and documents, or sending data elements in a proprietary format, do not qualify as interoperability. There is no interoperability, unless all computers everywhere have a thorough “understanding” of everything people wish to say to each other.

Machine interoperability is being touted as the silver bullet in our quest to improve care coordination, and rightfully so. Interoperable computers are the ultimate population managers. There is no better way to ensure that people don’t fall through the cracks of an increasingly fragmented system where continuity of care is being replaced by electronic coordination of services. Computers that are interoperable are immensely better at “remembering” all the services that are needed and the dates when services are due for each individual patient. Computers can also generate reminders and alerts to make sure that everybody is adherent to recommended therapies, and keep track of results and outcomes, particularly for patients with chronic disease and multiple comorbidities. Proper care coordination can thus reduce complications, errors of omission, preventable hospital admissions and unnecessary readmissions, saving the system boatloads of wasted money. No wonder then that the United States Senate and practically all experts in the field are adamant that interoperability should be our number one priority.

The following assessment of financial waste in health care comes from the man who invented the Triple Aim and introduced the patient-centered concept into mainstream conversation, Dr. Donald Berwick, a staunch supporter of the Affordable Care Act who was chosen by the Obama administration to lead the Centers for Medicare and Medicaid Services (CMS), a physician who actually practiced medicine, and a New England liberal.

If you tilt your head to the left at just the right angle, and squint a little while looking at this graphic, you will notice the comparatively negligible waste created by failure to coordinate care.  You will also notice that the majority of wasted health care dollars have almost nothing to do with actual patient care, whether it is coordinated or not.

Nevertheless, care coordination and its managed care alter ego, provided by interoperable machines, has become the battle cry of health care reform. Hospital consolidation, accountable care organizations, vertical integration, narrow networks, the proliferation of managed care, particularly for those dually eligible for Medicare and Medicaid, bundled payments, incentives and team care, all proclaim their goal to be better care coordination. Hundreds of billions of dollars are flying around, in a dizzying Triple Aim dance led by the falsetto of the interoperability orchestra.  Interoperability, and the incessant regulatory deluge aimed at promoting the so called data liquidity necessary for clinical information to flow in a thousand directions, contributes almost nothing to reductions in five of Dr. Berwick’s six wedges of waste, and for administrative complexity, which is the biggest waste of all, it actually makes things infinitely worse.

So why are our government and the overwhelming majority of our industry obsessed with interoperability? Because uniformly standardized machine interoperability is the one prerequisite to the creation and accumulation of Big Data for health care in particular, and for all other surveillance purposes in general.  Once enough Big Data is generated and dutifully allowed to flow uninhibited to entities beyond traditional health care organizations and their old and tired legacy systems, the fresh ideas from innovative entrepreneurs will sweep health care off its feet and transform it into a lean and mean transparent, effective and efficient machine that keeps us all safe and healthy at a fraction of today’s costs, or something like that. And, knock on wood, even immortality is now a tangible option trickling down from deranged Silicon Valley billionaires.

Back on Earth, there are early indications of how this free-flowing Big Data business will actually work. Setting an example for one and all, Medicare has begun releasing huge datasets to the public. A good illustration is the recent release of its physician payment data. The headlines triggered by this liberating act were swift and abundant: “Medicare Millionaires Emerge in Data on Doctor Payments”, “Top Medicare Ripoff Doc Is Dominican”, “Political Ties of Top Billers for Medicare”, “Sliver of Medicare Doctors Get Big Share of Payouts”, “Medicare pays hundreds of millions to Maryland providers”, “Florida has most doctors with $3 million in Medicare claims”, “Millions paid to Medicare doctors in Memphis”, “Is your doctor one of the 340 in Texas to make more than $1 million from Medicare?”, and my personal favorite, “Medicare Records Provide Tantalizing New Details Of Payments To Doctors”, plus thousands of more of the same.

Being tantalized is an integral part of being safe and healthy, and it seems that a good old fashioned witch-hunt is also highly recommended for rabble morale, not to mention the ad revenues generated by all this mindless click bait. Once interoperability is widespread and data flows freely, entrepreneurial companies may decide that it is in the public interest to be tantalized not only by millionaire doctors, but also by the million dollar babies who are feeding their habit. And since this is after all Big Data from certified EHRs, we can build very nifty HIPAA compliant databases to shed some light on the demographics of top health care spenders (e.g.  “Millions Paid by Medicaid for Out of Wedlock Births in Mississippi”, “Sliver of Children Spend Big Share of Health Care Dollars”, “Retired Millionaires Deplete the Medicare Trust Fund “, “Sexual Preferences of Top Spenders for Medicaid”, etc.).

If I may venture a guess though, wide scale interoperability is not blocked by antiquated moral or ethical concerns some of us may have. It is blocked by money. All serious EHR vendors are perfectly willing and fully capable of opening the database floodgates to release most clinical information out into the wilderness, but doing that costs lots of money. There are labor costs, hardware costs, maintenance costs, various certification costs, and practically no return on investment, and no other tangible benefits, for their clients or their clients’ patients. Industry captains, who beat the data liberation drums the loudest, charge small fortunes for interoperability, including transaction fees for every liberated medical record. Contrary to popular belief, interoperability is good for EHR vendors’ business, and it does not alleviate the so called “vendor lock in” problem one bit, which may explain why the most respected interoperability experts hail from the largest EHR companies.

So who are the true information blockers? You are. You, and all other people who are stubbornly refusing to pay EHR vendors for allowing you to collect irrelevant data, and for transferring these data to those who are creating a tantalizing new market for the personal information of your patients, are frustrating congressional intent. You should expect stiff penalties and punishments for noncompliance, because interoperability is not about technology or the sharing of pertinent clinical information at the point of care. Universal and comprehensive interoperability of machines is about the transfer of power and wealth, from patients and doctors, to large corporations.