Timeout for Measurement

These are exciting times for anyone involved in the Health Information Technology (HIT) industry. HIT has evolved from an obscure endeavor, with mild success, to a National priority. After all, how many industries can list the President of the United States as one of their most ardent champions? Two - clean energy and health IT. We have arrived. Federal funds are constantly flowing into the industry and ONC does a tremendous marketing and messaging job to increase sales of everything from small EHRs to large HIE platforms, and an amazing large number of industry leaders and very talented folks are exceedingly busy setting standards, policies and certifications. Publicly traded HIT companies are surpassing projected earnings and stock prices are on a healthy upwards trajectory. I suspect private enterprises are doing equally well, if not better.

Meaningful Use Stage 1 is pretty much a done deal with Stage 2 and 3 coming up fast. The Nationwide Health Information Network (NHIN) is slowly coming to life and so is its little cousin Project Direct (formerly known as NHIN Direct). Health Information Exchanges are sprouting up in every state due to Federal largesse or private efforts and according to Dr. Blumenthal the vast majority of hospitals and physicians are on board, or planning to be any day now. The crowds are cheering. First down and ten, at the 50 yard line! Or is it? Would it be too much trouble to ask for a measurement before we move the chains? I am starting to have an uneasy feeling that some adjustments may be necessary if we aim to “win the future”.

The current issue of Archives of Internal Medicine contains a study by Romano & Stafford titled “Electronic Health Records and Clinical Decision Support Systems” (CDS). The study period is from 2005 to 2007 and it is focused on ambulatory visits of over a quarter million patients nationwide. The findings “indicate no consistent association between EHRs and CDS and better quality”. The “rebuttal” comment is quoting the famous 2005 Garg et al. study which reached different conclusions. The Garg review is aggregating studies from the early seventies all the way to 2004 and concludes that “Many CDSSs improve practitioner performance. To date, the effects on patient outcomes remain understudied and, when studied, inconsistent.” I would agree that Romano and Stafford considered rather older technology, but whatever is sold to ambulatory offices today bears almost no resemblance to what Garg et al. studied.

Also this month, a U.K. based study published by the Public Library of Science (PLoS) and examining international publications, including the U.S., from 1997 to 2010, concludes that “There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated”. A month earlier, the American Journal of Managed Care published a study funded by the RAND Corporation which examined “the relationship between quality improvement and electronic health record (EHR) adoption in US hospitals”. Using data collected between 2003 and 2007, the authors concluded that “Mixed results suggest that current practices for implementation and use of EHRs have had a limited effect on quality improvement in US hospitals”.

At the very least, it seems that so far EHRs and perhaps even CDS are not making much difference to quality of care. Perhaps we are not measuring the right things. Perhaps all these studies suffer from flawed methodology. Perhaps Meaningful Use certified EHRs are much better than their predecessors. Perhaps when “meaningfully used” EHRs will yield better outcomes. Perhaps our assumptions, and associated expectations, are incorrect. If this is to be a “learning system”, shouldn’t we start learning?

In the January issue of Health Affairs, Advocate Physician Partners of Illinois is describing their model for creating an Accountable Care Organization (ACO), which includes quality improvements and cost reduction. It seems that Advocate had pretty good success with several quality initiatives. Oh yes, Advocate is using lots of HIT and EHRs to collect data, share information, coordinate care and measure progress. A case study for the Rhode Island Quality Institute (RIQI) published by the Commonwealth Fund in December 2010 describes RIQI efforts at improving quality of care in the state. According to the study, RIQI decided in 2005 to reduce ICU complications. By 2009 significant improvements have been achieved and associated costs were reduced by over $3M through a well-planned and massive collaborative effort of all hospitals in the state. There is a nice data table in the report quantifying these improvements. Next, as part of an HIT adoption program, “RIQI chose to increase electronic prescribing by providers as a strategy to reduce prescription errors.” The report goes on to list the impressive eRx adoption rates in Rhode Island, but there is no table for illustrating either reduction in prescription errors or savings associated with such effort. In 2003 Kaiser Permanente embarked on a quality improvement effort dubbed ALL (aspirin, lovastatin and lisinopril) to reduce incidence of heart attacks and strokes in people with diabetes or heart disease. The results as reported in 2009 were very favorable. Somewhere towards the bottom of the report, the Kaiser EHR is mentioned as the means by which patients were identified and collaboratively monitored.

There are many more such examples of quality improvements and cost savings achieved by health systems and physicians with assistance from HIT, with the most recent example of significant savings and health improvements being Dr. Atul Gawande’s latest article in the New Yorker describing cost reductions precisely by providing more and better care to those with highest utilization rates. “Care” in the context of this article refers to sitting with patients in hospital rooms and getting to know them, visiting their homes, assisting them beyond medical care and sometimes speaking to them with a nagging authoritative tone as their mother used to do when they were young. Rather peculiar approach in this day and age where relationships are defined through an Internet browser page. The doctors in the New Yorker article didn’t just stumble upon this archaic way of caring for unfortunate people. They planned, researched and implemented and, yes, they do use computers and data and EHRs. Are we learning yet?

We have reports and studies describing successful quality improvement projects that use HIT as one of the many tools employed by the organization, and we have studies of widespread implementations of HIT, mostly for the sake of implementing HIT, that show no benefits whatsoever. The Meaningful Use project is paying doctors to buy and use HIT in a prescriptive way. There are no stated quality or effectiveness goals, but the architects of Meaningful Use remind us that by 2015, we will be paying physicians for actual outcomes. Outcomes which would be facilitated and measured by all the HIT tools we are now putting in place. So by the time Meaningful Use Stage 3 comes about CMS will be resurrecting a Pay for Performance (P4P) program on steroids. Unfortunately, a new study from the U.K. which tracked half a million patients from 2000 to 2007, concludes that paying doctors for performance does not improve performance, as the chief researcher, Brian Serumaga, told the New York Times, “It seems policy is heading in one direction, while the evidence is heading in another direction”. The most succinct explanation to these findings is provided by an anonymous physician commenting on the study at kevinmd.com: “We are doing the best we can, given the situation we find ourselves in. If you incentivize us, we will still do the best we can given the situation we find ourselves in. Output change: virtually zero.”

We need to change “the situation we find ourselves in” before we can expect any improvements to health care. HIT and EHRs are only as powerful as the people employing them and those people are bound by the situation they find themselves in. The doctors in Rhode Island and those at Advocate and even those working for Kaiser were in a different situation than most. Dr. Jeffrey Brenner featured in the New Yorker story is an outlier who created his own “situation” and is currently operating on the edges of insolvency while saving boatloads of money to the system. There are probably many others out there, but to affect change on a national scale, they need support on a national scale. CMS would be well advised to shift its focus from micromanaging physicians’ tools to creating innovation where it really counts – health care delivery and reimbursement, particularly for Primary Care. Sadly, it’s only fourth down and inches. Do we predictably punt, or do we cleverly adjust a bit and go for it?

EHR Product Management

It has become politically incorrect to refer to EHRs as products. Instead, EHRs are now “technologies” as evident in all ONC and CMS published rules and regulations. This subtle change in terminology was intended to encourage, yes you guessed it, Innovation. It was supposed to signal an open market for alternatives to existing EHR products in the form of modular approaches, open platforms, mobile applications and web-based software-as-a-service. Naturally, the industry is obliging and all efforts now are geared towards creating stuff that runs on iPads, preferably “cloud” based and with minimal utility. The new stuff looks very cool and promises to become even cooler, so what’s the problem?

The problem is that these new things do not solve any problems. Traditional product innovation concentrated on identifying problems, designing solutions and then selecting technologies that were capable of enabling those solutions. New technologies were usually born out of the necessity to solve a burning problem and those with enough applicability to larger markets became blockbusters. Every frying-pan today sports technology first invented in the process of creating refrigerants and later used for nuclear destruction (Teflon). Every large enterprise embarking on cost cutting, new markets acquisition, or general improvements, should know all too well that selecting a “cool” technology first, and then attempting to find a good use for it, is recipe for failure. As a former good friend of mine used to say, “There are three types of companies: engineering driven, sales driven and successful”. Successful companies are market driven – they look for those needs and problems that people are willing to pay to have resolved. Very successful companies create their own new markets by creating new needs that people didn’t even know they had. Sometimes, during this process, new technologies are invented for the purpose of creating products that solve people’s problems. Customers usually buy products and services. Rarely, if ever, do they buy “technology”. Moreover, technology should be transparent to the user and really good technology should feel like magic.

Back to EHRs, we are now trying to convince physicians and hospitals to buy cutting edge EHR technology, some of which has not been invented just yet. We are asking them to buy open platforms, clouds, information networks and more recently search-engine optimized data architecture. And when they drag their feet in utter confusion, we label them Luddites and technophobes. Furthermore, those supposedly concentrating on the “next generation” of health care computer tools are designing them in deference to the same cutting edge technology requirements with almost no consideration for business process. And when the business model gets in the way of the chosen technology, then the business model must go. This is why you always find criticism of our “fragmented” mom-and-pop health care system and vilification of the fee-for-service model in most health care technology reports. We have moved from the pre-HITECH sales driven approach to EMR (with an M), to an engineering driven effort to increase EHR technology adoption. I would like to suggest a third option: the market driven Product Management route.

Forget about EHR and databases and servers and networks. What problems do physicians and hospitals face today? This of course is a huge question and the answer will vary based on many factors. Hospitals are different than individual physicians; large hospitals are nothing like small rural ones; physicians’ problems vary with specialty, practice location, practice type and time of day. But why start with providers? If this is a National discussion, shouldn’t we primarily consider what Government and consumers need? Unless you are aiming at selling something to the U.S. Government, or to individual patients, my answer would be a resounding, and unpopular, No. Of course, providers’ problems will be inextricably tied to constraints placed upon them by both Government and their own customers, but the paying customer for our imaginary Product is the provider, and as all other industries that we so eagerly want to copy, already know: The Customer is King.

At this point, you would go out and talk to your customers, potential customers and non-customers. Most existing provider surveys are asking people about barriers to EHR adoption and why providers would be interested in paying for an EHR. This is not a very “innovation fostering” approach. Considering the large spectrum of customers we are exploring here, if you asked an open-ended question about pressing problems, you would most often elicit two general responses: inadequacy of reimbursement and a perpetual desire to provide better care. These two overarching requirements translate into different things for different market segments. The reimbursement issue, for example, can be looked at in two ways. How do I get more money from payers? How do I cut my costs down so I decrease overhead and increase profit? Providing better care is an even larger subject and more controversial too. For a primary care doc, this could translate into a desire for more time with each patient. For a hospital, it could mean reducing complications. For both these examples, the computer would be required to actively do something that either consumes time now, or something that is so time consuming that it is not done at all. Writing for The Health Care Blog, Dr. Steve Sanders describes a very simple vision of how computers, integrated into operations, could reduce falls in hospitals by triggering well defined sequences of human actions. This is how computers are used in manufacturing and supply chain operations.

Identifying business problems and suggesting adequate solutions requires careful examination of workflows, identification of commonalities and opportunities and constraints posed by conflicting requirements and external factors. Then, and only then, comes the time to select, or build, technologies capable of supporting your customer’s business goals. In 2006, a computer scientist thought that putting medical records on mobile phones would be pretty cool. In 2009, Eric Schmidt had the same thought, this time involving a motorcycle trip to Mongolia. In 2011, someone else had a similar epiphany. It’s not catching on. Although, the concept is very cool, it is only incrementally cooler than flinging “Angry Birds” on your cell phone and nobody has been able to locate a market segment willing to pay for implementing this concept because “pay it forward” is not a viable business strategy.

How about National strategies? After all, introduction of computers into the health care system is now a centralized Federal enterprise. On the surface, Government’s goals are very similar to providers’ goals: cutting costs and improving care by measuring outcomes, with the added lofty goal of conducting research. There is, however, a “slight” problem here because Government’s costs translate into providers’ revenue and you will be hard pressed to find a paying customer interested in software that will decrease revenues. As to measuring outcomes, just imagine trying to sell people software tools that would allow the IRS to better and more intimately measure their tax liabilities. Not much of a market there. As to research, while everybody probably agrees that clinical research is worthwhile, very few businesses, in any industry, would volunteer funds and effort to advance national research initiatives with no immediate and tangible ROI to the business itself.

We have reached a fork in the road. Either EHRs are built and sold according to free market rules, with some Government oversight and regulation, or they become regulatory, Government mandated and Government designed tools, required to be purchased and used in prescribed ways as a condition of licensure to provide health care in this country. The latter option, which seems to be where we are headed, will add another painful customer problem in need of solving: minimizing Government intrusion. For savvy HIT Product Managers, it is time to formally design a solution and begin the search for the best technology to minimize the pain created by, the yet to be agreed upon, Government technology. HIT is now a self sustaining enterprise.

Comment on the PCAST Report

The public comment period for the PCAST report is now closed. Since those comments are public anyway, I thought I'd post here what I submitted to ONC (with minor formatting changes to fit the blog).

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This comment is not in response to the specific questions posed by ONC, which seem to presume a certain validity of the PCAST report. This comment is respectfully raising several basic questions, which in my opinion, the PCAST reports either did not address or circumvented. With this in mind, you may choose to continue reading, or not.

I would like to start by clarifying that I am now, and always have been, a strong proponent and supporter of appropriate computerization of medical records, HIT in general and the resulting opportunities for expanded clinical research. For the purpose of full disclosure, I have no financial or any other, interests in any HIT vendor.

1. Where does clinical data reside today?

• Providers - As we all know, there are massive amounts of paper based medical records residing within the walls of providers of all shapes and types. In addition to paper based records, there is a significant (and growing) amount of medical records maintained in electronic format by mostly large providers, but smaller ones as well. The vast majority of these records are created and stored in document format (scanned, dictated, typed, annotated, handwritten, transcribed, etc.). A small portion of this data is stored in structured format, mostly if not all, in relational databases. The most common discrete data elements are demographics, insurance details, diagnoses (ICD-9), procedures (CPT), vitals, and here and there lab results, immunizations, medications, some histories and relatively rarely, findings.
• Payers (including public ones) – Payer databases dwarf provider databases by orders of magnitude. Payer databases include demographic information collected whenever people enroll in a particular plan, which includes everything providers have and probably much more. Payer databases include every data element (structured) in an X12-837 EDI claim transaction, i.e. diagnoses (ICD-9), procedures (CPT) – including labs, imaging, immunizations, visits, treatments, hospitalizations, etc., places of service, durable medical equipment, extended care, home care, and through PBMs, all medications filled at pharmacies and billed to insurance. Payers do not have test results and imaging studies results.
• Laboratories and Imaging Centers – Everything payers lack is stored in the equally large databases of testing facilities and for most Lab results, the data is stored in structured format. According to the FTC, the two leading national reference labs (LabCorp and Quest) control approximately 89% of the market [1], which means that 89% percent of discrete lab results are maintained in structured format by two centralized authorities. Radiology and imaging studies are infinitely less centralized, although highly computerized as well.

2. How should clinical data be collected for clinical research?

• I don’t think anybody will disagree that it is much easier to extract data from a few centralized databases than it is to extract it from tens of thousands of smaller and diverse ones. The set of data elements contained in the union of payers, laboratories, radiology and imaging centers databases is lacking very little that can be provided from mining provider generated clinical data. As an aside, I would like to clarify that, contrary to common mythology, there should be no distinction between payers “billing codes” and provider maintained codified “problem lists”. If there is a discrepancy, it is either due to incompetency or plain fraud. Provider databases may contain longitudinal vital signs and perhaps more up to date allergies, smoking and drinking status. So why is the research effort concentrated on providers EHRs which, under best circumstances, are practically mirrors of already aggregated and analytics ready repositories?
• With very few exceptions, population level research data need not be available in real time and need not be extracted in milliseconds. While web crawling enabled technologies and infrastructures are very appealing, the cost of retrofitting every data repository with the means to bypass a Service Oriented Architecture (SOA) seems a bit unjustified and the benefits seem unclear to me in view of the multitude of algorithms continuously executing in payer databases with obvious benefits to that industry. As an additional note, I believe the report severely underestimates the costs to the industry to migrate to a web-based, data-element centric architecture, which will involve major changes to all payer, laboratory, pharmacy, clearinghouse, intermediaries, HIE, CDS, drug database providers, etc., in addition to the obvious impact on providers and their EHRs.

3. Does a browser based, research oriented infrastructure benefit health and health care?

• There is no question in my mind that a “universal language” for health care information exchange is necessary. Languages are composed of syntax and semantics.
• Syntax - There has been increasing agreement in the U.S. and other countries as well, that HL 7 v3, which is XML based, is capable of providing a universal syntax for data exchange either through messaging or through exchange of “documents”. Both messages and documents are based on extensible structures, with the added benefit that CDA is compatible with the needs of those who do not own and cannot process individual data elements. Those needs will be around for a very long time. Additionally, the CDA automatically provides context for all data elements it contains. One may argue that metadata tags can contain all contextual information required to recreate the CDA, in which case the question is why disaggregate the document in the first place? For illustration purposes, let’s assume that an MRI order is represented by a metadata tagged element. For a given physician, treating a given patient, seeing that an MRI was ordered sometime in the past is rather meaningless without the context of a progress note containing diagnoses, subjective and objective findings and perhaps other diagnostic tests. However, I can easily see a “measurement” being created from the proposed atomic data elements, to calculate all the MRIs ordered by Dr. X in a certain period of time. Dr. X would probably be rewarded or wrist-slapped if he ordered less-than/more-than the “norm”. Without the proper context this measurement would, of course, be meaningless. Obtaining the proper context would pretty much require the assembly of the CDA and application of appropriate logic to the query. This is a bit more complex than what a web-crawler is required to do.
• Semantics – Here too I believe the report underestimates the complexities involved in using multiple vocabularies, translated at the edges by some type of “middleware”. If you ever clicked on the “Translate this page” link in Google, or used an online translator to obtain a nice Latin quote, you should know that using arguments like “my middleware speaks more vocabularies than yours”[2 slide 6] cannot be taken seriously by anybody with any exposure to UMLS and SNOMED-CT.
• I have no doubt that creating a health care ecosystem based on atomic data elements is conducive to a plethora of research activities. Perhaps even clinical research. I am not certain though, that such activities will either improve health or reduce cost of health care. If you happened to read Dr. Gawande’s latest article[3], you should realize that health care is best AND most cost effectively delivered one patient at a time with very high-touch methodologies. Patient-centric was never meant to be interpreted as data-centric. Yes, computerized records can help tremendously, but I could not identify a single use case in the report that requires atomic data elements, or even benefits incrementally from such strategy.
• Both physicians and patients need to exchange meaningful information. I cannot identify with certainty one optimal way for such exchange. The Direct Project looks to me as very promising. However, if I may be allowed one more illustration, medical records are very similar to books, mostly collections of short stories. Patients and their primary care providers may want to have a copy of the entire book. Other providers may want a chapter or two, or even just an abstract, but nobody has any use for just words or sentences being moved across the wire. Most books do have an index, but that index serves as a pointer to contextual information. There can be no understanding without the context. If I say that my book contains an index to “death panels” which appears 50 times in the book, you still have no idea if this is a liberal book, a Tea Party manifesto, a history book about ancient tribunals, a critique of the NHS, or Mr. Boehner’s latest interview. Yes, we do know how to efficiently crawl around the web and aggregate billions of indexed locations with no particular context in mind, but just because we have a hammer…..

4. What is Government’s proper role in technology?
This is not about Meaningful Use, incentives, vision for a better future, or any lofty goals. This is about capriciously and arbitrarily influencing industries and markets.

• I do understand how technology serves manufacturing, retail and financial industries exceedingly well, but there is a reason why health care did not take the same path. As I wrote elsewhere, medicine is very different than other “industries” in that it lacks 100% repeatable processes. For example, the entire process of manufacturing, packaging, ordering, delivering, stocking and selling a box of Fruit Loops is exactly the same for every single Fruit Loops box. Automation of such process is easy. Unfortunately, people are not very similar to Fruit Loops boxes, and paradoxically, the lack of appeal and utility of current EHRs is in large part due to EHR designers thinking about Fruit Loops instead of the many ways in which people express pain and suffering. The legal industry is even less computerized than health care for the same exact reason. I do understand the frustration of technical folks and research oriented scholars with the slow adoption of HIT by physicians, but the answer is not to decree exactly how medicine should be practiced, and how it should be paid for, just so that it accommodates existing technologies, no matter how cutting edge their inventors seem to think those are.
• I am familiar with the various theories of innovation, disruptive innovation, fostering innovation, stifling innovation and all other derivatives of what has become a meaningless term. I don’t see how Government’s role extends to arbitrarily deciding that some products are “legacy” and others, yet to be invented are not, and to creating a “vibrant market of innovators”. “Vibrant market” should suffice. Is Government engaged in similar efforts in other “industries”, whether those are technically advanced or not? Yes, there is a host of incumbent technology vendors in HIT, and yes, they are well entrenched and getting more so as adoption rates are increasing, and yes, their products are well positioned for improvement. Has the Government decided that these vendors are unable to be “innovative”? Has anybody done a bit of “longitudinal” research on how products have changed in the last few years? I do understand there is significant private capital on the sidelines, waiting impatiently to enter the “market” [2 slide 3], but is it proper for the U.S. Government to “pave the way” by imposing new regulations on the industry, which may or may not be appropriate, just so that room is made for those who could not enter, or gain enough share of the market on merit alone? Is this what we now consider innovation?
• We will probably be better served if Government, or CMS, just defined what the outputs and inputs should be, what the rewards and penalties are, and let physicians, hospitals, HIT and the rest of the industry figure out how best to deliver. You would probably see some serious and true innovation right there.

Thank you for reading what has ballooned to 5 times what I intended it to be.

[1] http://www.ftc.gov/opa/2010/12/labcorp.shtm
[2] http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_0_8069_3354_21743_43/http%3B/wci-pubcontent/publish/onc/public_communities/_content/files/brieftooncworkgroup20110114.pdf
[3] http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html

That Which We Call a Rose

What’s in a name? Sometimes nothing much. Sometimes a shift in paradigm.

The Medical Record in its current format was created over a century ago by Dr. Henry Stanley Plummer at the Mayo Clinic. When in the course of human events the Medical Record began migrating from paper folders to computer files, the Institute Of Medicine naturally named the new invention Computer-based Patient Record System (CPRS). The Medical Records Institute chose the term Electronic Patient Record (EPR). Somewhere along the line the “patient” got dropped from the concept and the software used to compose and store medical records became known as Electronic Medical Record and the name EMR stuck.

As the EMR software evolved and started exhibiting rudimentary information exchange abilities and some semblance of “intelligence”, it was felt that a name change was in order. To differentiate the newer and smarter software from the original EMR, the term Electronic Health Record (EHR) was introduced and is now enthusiastically supported by the Federal Government. The term EHR is used in acts of Congress, rule makings from CMS and ONC and Presidential speeches. Since EMR has been around for quite some time, most industry veterans, as well as most doctors, are a bit confused about the new terminology. Is it EMR or is it EHR? Is it just semantics? Would an EMR by any other name smell as sweet (bitter)?

In a recent ONC blog, Peter Garrett and Joshua Seidman argue that there is a significant difference between EMR and EHR. The former is just “a digital version of the paper charts” and “not much better than a paper record”, while the latter is “designed to be accessed by all people involved in the patients care”, including patients, and generally “represents the ability to easily share medical information among stakeholders and to have a patient’s information follow him or her through the various modalities of care engaged by that individual”. This dramatic difference stems from replacing the word “Medical”, which implies disease, with the word “Health” which is “the general condition of the body”. Note that the word “Patient” is still absent. However, Health is supposedly from cradle to grave, while Medical is episodic in nature. Since, no matter what you call it, clinicians are the primary users of this software, would we say that doctors provide Medical Care or Health Care?

When we say that cost of Health Care is sky-rocketing, we don’t usually include costs for clean air, clean water, car seatbelts and gym memberships, and although we all know that an apple a day keeps the doctor away, the cost of apples is not included in our Health Care expenditures. To be sure, Medicine, “the science and art dealing with the maintenance of health and the prevention, alleviation, or cure of disease”, does include costs for direct prevention of specific diseases (immunizations) and efforts for early diagnosis of others (screenings). Historically, doctors, nurses and their less formally educated predecessors have been tending to the very sick. It is with this goal in mind that Dr. Plummer’s collaborative Medical record was created, and it is for this purpose that the American Academy of Pediatrics advocated for a Medical home for sick children, and it is Medical care for the sick which the EMR attempted to facilitate, one patient at a time. The EHR represents quite a different philosophy and places new and expanded responsibilities on the Medical profession.

The EHR is intended to serve the healthy as well as the sick, and the President’s vision is that every American should have one, whether that particular American is healthy or not. The ONC vision, shared by many innovators in the field, is that “EHRs focus on the total health of the patient—going beyond standard clinical data collected in the provider’s office and inclusive of a broader view on a patient’s care”. That broader view will presumably include lifestyle habits, diet and exercise and everything one may wish to record which pertains to one’s general health status. If and when a person becomes ill and is transformed into a patient, the various clinicians and care providers will contribute their documentation to the EHR, and since EHRs are easily shareable, all Medical care will be coordinated through the EHR and collaboration will flourish, as it should. This sounds almost exactly the same as what a Personal Health Record (PHR) is supposed to be. Is an EHR really a PHR?

No. EHRs include one feature that is not possible in a PHR: the ability to aggregate individual patients into populations. When physicians write introspectively about their work, you usually find stories about this or that particular patient, pondering whether they did too much for the 90-year-old Alzheimer’s victim, or too little for the misdiagnosed 40-year-old ovarian cancer patient. They talk about emotions, or lack thereof, about small victories and exasperatingly “non-compliant” middle aged executives who should know better. Each story has a patient with a name, physical details and most often character description. For those inclined to self-assessment, the day-in and day-out tally of these personal episodes is the decisive yardstick. When people recommend a doctor to a friend, they usually talk about “nobody could figure out what was wrong with Katie; he took one look at her and knew right away” or “you can get in today or tomorrow and she is so nice and patient ; always takes my phone calls and you know I can be a pain (giggle)” or “when Adam had that knee problem, he fixed it like magic and he did surgery on cousin Joe’s shoulder; as good as new, and I think he takes care of the Cardinals too; he is definitely the best in town”.

This unscientific, anecdotal method of both performing and assessing one’s work will be replaced by the broader view of EHR enabled population indicators and considerations. Instead of dealing with Mr. Wilson’s gout and Mrs. Wilson’s incontinence, you are now the keeper of the Health of Populations. The EHR can tell you that half of your under 40 patients are obese and doing absolutely nothing about it. You, or your team, will need to intervene because an ounce of prevention today will lead to healthier lives for this population, and lower costs for society. While managing Mrs. Wilson’s neuropathy is important (especially to Mrs. Wilson), having your population of 300 diabetics controlled within acceptable cost effective parameters will become the main focus of your practice. EHRs will provide you with the intelligence (information) to manage your numbers and with ongoing measurements to assess your performance against goals, and EHRs will continuously collect data for ground-breaking research and more effective recommendations.

EHRs, as imperfect, ineffective and downright primitive, as they are today may be our first glimpse of a future where curing or treating disease is largely a thing of the past. If populations are proactively managed and everybody gets their shots and recommended genetic therapy, or whatever they will come up with next, Medical care will be limited to trauma and exotic ailments that have not been researched just yet. While our generation will not be crossing the River into the Promised Land of perpetual Health, it is up to us to manage this transition so human dignity is preserved and collateral damage is minimized in the process of industrializing medicine, a process which starts with changing the M in EMR to the H in EHR.

Failure is Not an Option

2010 is drawing to an end amongst a flurry of activities in the Health IT field. In a few short days 2011, the year of the Meaningful Use, will be upon us and the stimulus clocks will start ticking furiously. In addition to the yearlong visionary activities from ONC, December 2010 brought us two landmark opinions on the future of medical informatics. The first report, from the President’s Council of Advisors on Science and Technology (PCAST), recommended the creation of a brand new extensible universal health language, along with accelerated and increased government spending on Health IT. Exact dollar amounts were not specified. The second report from the Institute of Medicine (IOM) is a preliminary summary of a three-part workshop conducted by the Roundtable on Value & Science-Driven Health Care with support from ONC, and titled “Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care”. The IOM report, which incorporates the PCAST recommendations by reference, is breath taking in its vision of an Ultra-Large-System (ULS) consisting of a smart health grid spanning the globe, collecting and exchanging clinical (and non-clinical) data in real-time. Similar to PCAST, the IOM report focuses on the massive research opportunities inherent in such global infrastructure, and like the PCAST report, the IOM summary makes no attempt to estimate costs.

Make no mistake, the IOM vision of a Global Health Grid is equal in magnitude to John Kennedy’s quest for “landing a man on the moon and returning him safely to the earth” and may prove to be infinitely more beneficial to humanity than the Apollo missions were. However, right now, Houston, we’ve had a problem here:

1. The nation spent upwards of $2.5 trillion on medical services this year
2. Over 58 million Americans are poor enough to qualify for Medicaid 
3. Over 46 million Americans are old enough to qualify for Medicare 
4. Another 50 million residents are without any health insurance
5. The unemployment rate is at 9.8% with an additional 7.2% underemployed
6. This year’s federal deficit is over $1.3 trillion and the national debt is at $13.9 trillion

In all fairness, the recent Federal investments in Health IT were spurred by the HITECH Act, which was a part of the ARRA, a recession stimulus bill aimed at injecting money into an ailing economy and creating jobs, while improving national infrastructure. It was not explicitly intended to reduce health care costs or improve access and affordability (that came later with PPACA). Perhaps adding an EHR to every doctor’s office was viewed as the first step towards building the Learning Health System. However, somewhere along the road to fame EHRs were magically endowed with powers to provide patients “with improved quality and safety, more efficient care and better outcomes”. Perhaps these claims came from EHR vendors’ glossy marketing collateral, or perhaps it was just wishful thinking, or perhaps this was a forward looking statement for the fully operational grid of a Learning Health System, or maybe this is just incorrect use of terminology. Health IT is much more than EHRs and Health IT can indeed help improve efficiency, i.e. cut costs, in several ways.

Administrative Simplifications

Section 1104 of the PPACA contains a roadmap for administrative simplifications “to reduce the clerical burden on patients, health care providers, and health plans”. Eligibility transactions must be standardized and deployed by 2012, electronic payments by 2014 and claims, certifications and authorizations by 2016. Physicians spend about 14% of revenue on billing and insurance related functions, while hospitals spend 7% - 11% and health plans spend around 8%, not to mention the aggravation involved. Why do we have to wait 6 years before this particularly wasteful activity is completely addressed? If there is a place where health care can learn from other industries, this is the one. Both the banking and retail industries have solved this problem many years ago. It is trivial to imagine swiping a magnetic card at the doctor’s office to verify eligibility, obtain authorization, and exact dollar amounts for patient responsibility, while initiating a real time payment transaction from insurer to provider. The complexities of a thousand different plans can be easily accommodated by computer algorithms and the technology is available in every supermarket and every gas station. For all those joining Congress in 2011 with the intent of altering PPACA, could we alter Section 1104 and shorten the timeline by a few years?

Fraud

The National Health Care Anti-Fraud Association estimates the costs of health care fraud to be 3% to 10% of expenditures. Despite all the publicity, credit card fraud is estimated to cost 7 cents per each $100 in transactions, or 0.07%, with issue resolution times estimated at 21 hours. This is yet another lesson health care can learn from the financial industry. Granted, purchase patterns in health care are different than the market at large, so the anti-fraud algorithms will need to be tweaked and specialized. Computers are very good at this and from watching the President’s bi-partisan meeting on health care reform last year, I thought this is one area where everybody agrees that something needs to be done. There is nothing tangible in PPACA regarding the use of Health IT for fraud reduction.

Duplication of Tests

If you prescribe electronically through Surescripts, you can see a patient’s medications list courtesy of the PBM. PBMs and insurers know exactly what medications they paid for. They also know exactly what procedures, tests and visits they paid for, and who performed them. Would it be a huge stretch of imagination to envision a display of the last 6 months of tests paid by the insurer every time you attempt to order a test? No, insurers don’t have the results, but if you saw that the patient had an MRI last week, would you order another one today? Or would you call the facility for a copy? When you prescribe electronically, the PBM insists on showing you the formulary and drug price for the individual patient. Why not show you prices for the tests you are about to order, and help you and the patient choose lower priced facilities, just like they steer folks to prescribe generics? This has nothing to do with clinical decision support or changing the way medicine is practiced. These are examples of very simple, common-sense, immediate solutions for reigning in costs without disturbing quality of care.

The Global Learning Health System presents a compelling vision. I wish that the President would commission the necessary budget estimations, go before Congress and in a JFK style oration request appropriations for defeating Cancer (or some other scary thing), appropriations which will include funding for the Learning Health System global grid. It is possible that if such Learning Health System existed today, or could be quickly deployed, it would provide solutions for most health care problems we currently have. However, it is pretty clear that such a system will take many years and many billions of dollars to build. In the meantime we have an immediate problem, which requires an immediate solution with immediately available tools, and no, failure is still not an option.

Health IT and the Carob Tree

At a certain point in time, somewhere in America, someone stated that people should all have lifetime, complete medical records. Sounds reasonable and I presume nobody ever asked, “Why?” As time goes by and health care services in America are approaching an unsustainable 18% GDP, the mythical lifetime record is quickly becoming panacea to the obvious problem health care has become. Americans accustomed to thinking about their health care as “the best in the world” are now being instructed that American health care is fraught with errors, needless deaths, unsafe treatments, uninformed physicians, unsanitary hospitals and basically stuck in the stone age of technology. And all this while sucking inordinate amounts of cash from simple-minded folks who have “no skin in the game” and thus completely oblivious to being robbed, bankrupted, maimed and killed by greedy health care providers and industry financiers. Don’t know about anybody else, but I am positively terrified... mortified... petrified... stupefied... by this.

Enter the aforementioned lifetime health record, a.k.a. “EHR for every American by 2014”.  EHR in this context denotes collections of information or data, not a software product. Instead of overstuffed manila folders and oversized yellow envelopes, each one of us will have a complete electronic dossier, stored somewhere TBD later, chock full of every lab result and imaging study we ever had, all blood pressure, weight, height, temperature, etc. ever taken, all pre-op, post-op, consultation and progress notes ever written, all diagnoses and medications, all cuts and bruises, all chief complaints and histories and all treatment plans that we followed and even those that we did not. When our EHR is ready for use, doctors will be making fewer errors, order fewer unnecessary tests, make more informed decisions, prescribe safer treatments and charge less money for more thorough work. Well, maybe the last one is a bit of a stretch….

Problem #1: Do we really need a comprehensive lifetime health record? Here and there, particularly for small children with chronic conditions, such record will be clinically meaningful. For the vast majority of Americans, a lifetime EHR may be a cute thing to have but not really a necessity. One may need records for recent years if managing chronic disease or battling a potentially fatal diagnosis, but for everybody else, including the exotic case of someone ending up in the ER unconscious, buck naked and all alone, the most you will need is a brief summary of vital information. So if we don’t need our pre-school growth charts and we don’t need an itemized litany of every URI we ever had, every story we told our doctor and every “RRR, normal S1, S2 and without murmur, gallop, or rub” ever recorded, what is it that we do need? I guess a reasonably healthy 40-year-old could derive some joy from perusing his comprehensive lifetime record – “Look honey, that awful cold I had in the winter of 87’ when we went skiing for the first time was really pneumonia. No wonder I broke my leg the next day… It’s all here. Isn’t this great?”  When the same 40-year-old goes to see his new family doc the next day for persistent “heartburn”, his 87’ adventure would be largely irrelevant, and if he ends up unconscious and naked at the ED that night, they may be interested in his recent “heartburn”, but still have no use for information on his hapless skiing vacation 23 years ago.

As Dr. David Kibbe aptly observed, what we, or our health care providers need, very much depends on the context. Defining a relevant superset of information should of course be left to practicing physicians, but if I had to define such superset, I would go with immunizations, problem list and medications (current, with option to view historical), allergies, a couple of years of lab results and imaging studies (longer for certain studies), standard major medical and family histories and for chronic or serious conditions, the last few physician notes. Interestingly enough, these data elements are already being captured in structured and codified manner by most currently available technologies. If money were no object, I don’t see a downside to cataloging and retaining every tiny piece of information, provided that it can be contextually filtered for different circumstances. But judging by the billions of dollars being spent on HIT, money is a very big object indeed and either way, those who care for unconscious, naked people presenting at the ED in the middle of the night, should not be expected to peruse lifetime records.

Problem #2: How do we get access to either comprehensive or contextually appropriate information? As we all know, our “fragmented” health care system is nothing but a collection of data “silos” maintained mainly on paper under lock and key by greedy providers, no doubt purposely so in order to maintain a competitive advantage in a brutal health care market where an overabundance of physicians are fiercely competing for an ever dwindling number of patients . Or maybe not…. Perhaps traffic of clinical information has been severely hampered by that one antiquated oath physicians still take which commands doctors to keep patient information downright secret. Either way, since in most instances people are treated by multiple providers, medical information must be shared between providers and certainly must be available to patients electronically (faxing, copying and phone calls are so uncool). Unfortunately, we don’t have a national healthcare system where all providers are employed by one entity, conform to one set of policies, use one technology platform and clinical data is easily shared. We do, however, have a few “look alike” entities such as Kaiser and the VA. Why not do away with the remaining “fragments” and consolidate our health care in a handful (a single one would be too Socialist) of fully integrated systems? It would certainly simplify things for HIT grand-designers and programmers.

The financial system, our beacon of informatics wisdom, has resolved this pesky problem long ago, as evident in the world-spanning network of ATMs, where card carrying customers with unique identifiers can exchange several bytes of information with their remote financial institution. For those desiring comprehensive financial records, there is Yodlee and Mint, which will aggregate all your financial accounts in one cloud based dashboard free of charge (any takers?). Strangely enough this hallmark interoperability accomplishment did not require federal funding, government committees or a compulsory “universal financial language” (arithmetic seldom does). One can never be certain, but it is possible that financial IT experts were less obsessed with fostering/stifling innovation and more concerned with providing pragmatic solutions to real problems without requiring that banks change the way “financial services are delivered” or that smaller banks cease to exist in order to simplify software programming.

Problem #3: Should we plant a carob tree? Legend has it that carob trees require 70 years to reach maturity and bear fruit (more like 7 really), thus planting a carob tree is a selfless act to benefit posterity. There is a remarkable disconnect between the voice of physicians who treat twenty, thirty patients every day, one patient at a time, and physicians in the academia and those in “leadership” roles who routinely converse about population health, bio-surveillance and clinical research. Doctors who make a living by touching patients today, not tomorrow and not after Meaningful Use Stage 5 has been achieved, usually find that an EHR has very little to contribute to the quality of care they deliver to the one patient in front of them. Health IT is promising them a paperless future, devoid of software and hardware both, where every metadata tagged digital piece of information about their patient is “a click of a button” away. Health care delivery will become well informed, efficient and flawless to the point that the patient may not even need to be “seen” in order to be treated. Magically frightening? No; just futuristic technology which may come to fruition in, say, 70 years. Perhaps EHRs are our carob trees.

Moral: If you insist on planting nothing but carob trees, you will starve to death and there will be no one left to enjoy the fruits of the carob tree.

Thoughts on the PCAST Report

The President’s Council of Advisors on Science and Technology (PCAST) released a report this month ambitiously titled “REALIZING THE FULL POTENTIAL OF HEALTH INFORMATION TECHNOLOGY TO IMPROVE HEALTHCARE FOR AMERICANS: THE PATH FORWARD”, complete with current state of HIT analysis and authoritative recommendations to ONC, CMS and HHS on how to proceed going forward. Initially, I skimmed through the 90 pages of the report and very much liked what I saw. PCAST is recommending a federated model for health information, with medical records stored where they are created and a comprehensive view aggregated on the fly on an as-needed basis by authorized users, including patients and their families. PCAST is urging ONC to significantly accelerate efforts in this direction.  Perfect. And then I took a deeper dive into the details of the report, and disappointingly came across a series of misconceptions and questionable assumptions surrounding what is basically a very good, albeit expensive, strategy.

The State of Affairs

The classic opening to all HIT reports seems to be the obligatory comparison to “other industries”: “Information technology, along with associated managerial and organizational changes, has brought substantial productivity gains to manufacturing, retailing, and many other industries. Healthcare is poised to make a similar transition, but some basic changes in approach are needed to realize the potential of healthcare IT”. While this is true, we should also recognize that medicine is very different than other “industries” in that it lacks 100% repeatable processes. For example, the entire process of manufacturing, packaging, ordering, delivering, stocking and selling a box of Fruit Loops is exactly the same for every single Fruit Loops box. Automation of such process is easy. Unfortunately, people are not very similar to Fruit Loops boxes, and paradoxically, the lack of appeal and utility of current EHRs is in large part due to EHR designers thinking about Fruit Loops instead of the many ways in which people express Severity or Location.

The PCAST report continues with the common mantra regarding our “fragmented” health care system and the fee-for-service model which is preventing the availability of complete health information at the point of care and the advantages of larger health systems which, unlike small practices, “have an incentive to provide care efficiently and reduce duplication or extraneous services when possible”. They must be referring to Integrated Delivery Systems (IDN), since large hospitals and multi-specialty groups have many incentives, but reducing extraneous services is not one of them and if there is an entity which lives or dies by achieving efficiency, it is the solo or small practice operating on abysmal margins. Either way, we need technology recommendations for an existing health care system, not so much for some utopian system were payers and providers cheerfully align their interests with patients and tax payers in general.

Legacy and Condensed Water Vapors

Unsurprisingly the overarching thread in the report is describing current EHR systems as “legacy” systems, which will eventually become obsolete and make room for “innovative” technologies delivered via the Clouds. I can see how using centrally deployed and managed applications (not really a new concept) can be easier and more cost effective for most providers, but does the software have to reside in a vendor datacenter in order to qualify for a “no more software” stamp of approval? Would the many Epic installations accessed remotely by physicians qualify as Clouds? Or must they be deployed in an Epic owned datacenter, and be natively browser based, in order for the software to mysteriously vanish? Or perhaps Epic is too large and thus too heavy to ascend to the clouds? Epic, the fastest selling EHR system in the country, is a “legacy” product built on the 1960s MUMPS programming language, and so is VistA, the Veterans Affairs (VA) EMR, which seems to be a physicians’ all-time favorite. Perhaps the European Space Agency knows something we don’t, since they are taking MUMPS straight through the clouds and all the way up into outer space to map the Milky Way Galaxy.

After affixing the “legacy” label on the EHR industry incumbents, the PCAST report repeatedly emphasizes the government’s role in creating a “vibrant market of innovators”, particularly the “disruptive” type, citing the example of ARRA incentives leading to “substantial innovation and competition” and “more affordable systems and improved products”. This is pure fantasy. Some of the smaller, previously most affordable, EHRs have been forced to double their prices in order to comply with regulations. Most of the larger (legacy?) products have maintained their pre-ARRA pricing, or increased them. And then there are the literally all cloud, and no software to speak of, vendors, who preyed on physicians before ARRA and are continuing to do so after. It seems that Apple and its iTunes App Store has created the illusion that any kid with a completed “Programming for Dummies” curriculum can whip up a useful clinical decision support application in a couple of weeks, sell it on the App Store for $0.99 and help us all get healthy, if we would only give him access to mountains of personal medical records.

Privacy or Lack Thereof

The beauty of the PCAST recommended solution for health information exchange (details below) is that privacy preferences are built into each data element. Anyone attempting to access personal health information would be required to authenticate and validate that the patient’s privacy policy allows access to the requested data element. Moreover, all data will be encrypted both at rest and in transit between users, thus barring all intermediaries from reading or storing any personal information. Rock solid plan; that is until you run into this statement: “It seems likely that the modifications to HIPAA enacted in Subtitle D of the HITECH Act—in particular those that require covered entities to track all disclosures to associates—will further stifle innovation in the health IT field while offering little additional real-world privacy protection”. The PCAST authors seem to dislike the idea of tracking disclosures of personal health information.  Somehow, uninhibited disclosure (or outright wholesale) of patients’ private information to “associates” is a necessary condition for “innovation”. Makes you wonder what exactly is meant by “innovation”.

The Grand Solution

Let me say this again. I love the distributed data concept at the heart of PCAST’s recommendations. No big databases in the sky here. All the pieces of one’s medical record are housed by the institution that created each piece. When someone needs access to a record, or part of a record, an authorized query is issued (think Google search) and the requested information is located and aggregated across multiple data stores and displayed on the requestor’s computer screen (think Google again). The mechanism to achieve such wondrous task is by and large the same one Google uses, with added layers of security and privacy. These tools are dubbed "data element access services (DEAS)" which are nothing more than customized search engines for health information, maintained and operated by large health systems or purposefully built entities. As is the case with Google search, medical records will need to be indexed if the DEAS are going to find them. For this purpose, PCAST suggests “a universal extensible language for the exchange of health information based on “metadata-tagged data elements””. In plain English, medical records will be broken into atomic data elements, each having attached information describing the element (patient identifiers, what it is, when recorded, how, by whom, etc.) and most importantly who can access it (patient directed privacy rules). The search engines will presumably use these metadata tags to locate actual data elements, without ever needing to read the data itself, and return the results to the querying user. Of course, there are more questions than answers at this point, and some interesting discussions too, but the general concept is sound and very innovative.

Beware the Legacy Giants

While PCAST was deliberating and formulating its recommendations, at least one “legacy” EHR vendor was implementing the solution. During its user conference in October, Cerner unveiled “Chart Search”, which is a semantic search engine using Natural Language Processing (NLP) and a specific ontology to allow users to intelligently search a patient’s chart. As in PCAST’s recommendations, Cerner is indexing all medical records and is storing the indices in its own datacenter (cloud). The use of NLP and clinical terminologies, such as SNOMED, allows Cerner to perform contextual searches by concepts (searching for beta-blocker will return all occurrences of Atenolol, Metoprolol, etc.) and rank the most clinically pertinent results on top. You can view a very brief presentation of this feature, shown by my favorite family doc, Dr. Karl Kochendorfer, here. The Cerner semantic search is different than PCAST’s recommended solution in many ways and of course, right now it is limited to Cerner charts in one physical location, but it is real and currently used by actual physicians. Looks like those old “legacy” giants are still packing some punch after all.

In summary, PCAST’s basic concept of where HIT should be headed is very appealing and properly ambitious. The serious considerations given to privacy, security and patient preferences are refreshing, but in order to support the fascinating research agenda proposed in the report, government will at some point need to step in and curb the enthusiasm of Cloud owners, severely curtailing the commerce of medical records. I would have preferred that PCAST refrained from the fashionable and rather baseless assumptions on how innovation occurs and the equally worn-out subtle advocacy for unproven changes to our health care delivery system. Other than that, very interesting report.

Full disclosure: I have no financial interests in Epic, Cerner or any other EHR vendor