Tuesday, December 28, 2010

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 qu`lity 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.

Wednesday, December 22, 2010

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.

Thursday, December 16, 2010

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 ard 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

Sunday, December 12, 2010

Selecting an EHR for the Patient Centered Medical Home

The conceptual definition of a Patient Centered Medical Home (PCMH) speaks of a physician directed medical practice, oriented to the whole person, where patients have enhanced access to a personal physician and care is coordinated and integrated focusing on quality and safety, nothing more and nothing less, other than appropriate payment to physicians for all activities.

Since concepts are rarely enough, the National Committee for Quality Assurance (NCQA) took it upon itself to provide concrete requirements and formal certification for medical practices desirous of being recognized as Patient Centered Medical Homes. The NCQA PCMH definition consists of nine Standards used to score the practice. This is NCQA’s attempt at translating the original PCMH concept into measurable activities and here is where Health Information Technologies (HIT) and EHR in particular, are formally associated with the PCMH concept. Conspicuously absent from the NCQA standard are the “personal physician” and unless you consider the assessment of language barriers sufficient, so is the “whole person orientation". Most NCQA PCMH elements are geared towards data collection, data analysis, tracking and reporting. Theoretically, you could earn NCQA PCMH designation without an EHR, but the amount of typing, writing, filing and calculating would easily consume your entire day. If you are serious about PCMH designation, you will need an EHR. But which one should you get? Are some technologies better than others for PCMH purposes?

Unfortunately, no one is trying to answer these questions and perhaps this is one of the reasons for the initial mixed results observed in PCMH implementations. The HITECH Act put in motion a monumental rush towards Meaningful Use and associated financial incentives. The Patient Protection and Affordable Care Act (ACA) is initiating another rush, this time towards new payment models and PCMH seems to be at the heart of all innovations. So what should we do first, buy HIT and become Meaningful Users, or transform our practices into an NCQA PCMH? Some would say, let’s do both and others, mostly primary care physicians in small private practice, would say, let’s do neither. In reality, Meaningful Use trumps PCMH right now, since it has hard due-dates and specific dollar amounts associated with it. Moreover, the pervasive opinion amongst PCMH consultants (yes, they have those already) is to get the HIT part over with, before engaging in the complex PCMH "culture transformation". And this is yet another recipe for failure, driven by tactical instant gratification needs and inability to take the time necessary for formulating long term strategies.

Suppose you decide to build a tree-house for your kids. Since you’re a doctor, not a carpenter, what do you do next? You could go on the Internet and figure out what tools and materials you need, measure the big old oak tree in the backyard, talk to the neighbor that just built one and make a list of stuff you would need to buy for the project. Or you could just get in the car and rush to Home Depot because they have a holiday sale on hammers & nails and buy a truckload of random tools and lumber. If you pick the latter route, chances are most of what you bought will be rotting in your garage and the kids will be playing in the neighbor’s tree-house. Similarly, if you want to build a PCMH and randomly purchase some EHR tool just because the Government is giving out rebates and vendors have fire sales, chances are your PCMH will never take off successfully. Below is a list of NCQA PCMH standards and things you need to consider when shopping for an EHR with the goal of eventually obtaining NCQA PCMH recognition (items marked with ** are mandatory).

Standard 1: Access and Communication
  1. Has written standards for patient access and patient communication** - An EHR won’t help you write the standards, but it will help you implement them. You should have a scheduler that enables you to easily set aside times for open schedule, allows creation of global scheduling templates and gives you the ability to define your own appointment types, including web visits and email encounters. The EHR should also have the ability to create encounter notes without an appointment and/or a physical office visit.
  2. Uses data to show it meets its standards for patient access and communication** - The EHR should have built-in capabilities to report on aggregate schedules and be able to account for email communications and web visits in one comprehensive report.
Standard 2: Patient Tracking and Registry Functions
  1. Uses data system for basic patient information (mostly non-clinical data) – Any good Practice Management System will do here.
  2. Has clinical data system with clinical data in searchable data fields – This is your Registry. Querying the Registry should be flexible and allow multiple parameters (e.g. all diabetics taking drug A, but not drug B, with A1c in a certain range, who also have a Dx of HTN and have not been seen in 6 months), but should not require that you have a degree in applied mathematics to use it. The quality of registries in EHRs varies wildly. Make sure the reports look clear, that all columns are sortable and that the reports are actionable (i.e. clicking on a data element will allow you to do something about it right then and there, instead of having to print the report out and search for each patient).
  3. Uses the clinical data system – If you have that nice Registry, you would probably use it. For this element and the next two, the Registry should be able to report on itself (i.e. how many queries were run in a certain time period – an audit log is not sufficient).
  4. Uses paper or electronic-based charting tools to organize clinical information** - Same as above.
  5. Uses data to identify important diagnoses and conditions in practice** - Same as above.
  6. Generates lists of patients and reminds patients and clinicians of services needed (population management) – With a good and actionable Registry, sending reminders out to patients should be easy, but you need to verify that the functionality to send bulk reminders (by email, phone or mail merge) is there and it defaults to recorded patient preferences for communications.
Standard 3: Care Management
  1. Adopts and implements evidence-based guidelines for three conditions ** - The EHR should come with built in clinical decision support from a reputable source, such as USPSTF and this should be updated by the vendor on a regular basis. It should also come with clinical documentation templates, care plans and order sets preconfigured based on equally reputable guidelines. Be sure to ask about it and verify that it is actually as the vendor claims it to be.
  2. Generates reminders about preventive services for clinicians – The Registry should be able to be queried automatically in scheduled batch mode for all patients and it should also allow customized configuration to display overdue services when a chart is accessed (you don’t want pop-ups here – a gentle, but bold, reminder on the page itself should suffice).
  3. Uses non-physician staff to manage patient care – Every decent EHR will allow you to do this, but it would be nice if the EHR recorded the user who enters data into the various portions of the chart (not just an audit log, but visible indication that nurse A took the vitals).
  4. Conducts care management, including care plans, assessing progress, addressing barriers – The EHR should come with preconfigured, evidence-based and fully customizable care plans. It should also have a place to enter goals and subsequently calculate adherence to those goals. This is where you want the longitudinal display, particularly useful for chronic disease management.
  5. Coordinates care//follow-up for patients who receive care in inpatient and outpatient facilities – This will probably be done by phone & fax for a while longer, but your EHR should have capabilities to interface with hospitals and other providers. Some of the larger vendors have the ability to exchange information within networks of their own customers, and all vendors will eventually have to play nice. I know this is not a popular view, but for interoperability with multiple complex sources, the bigger the vendor, the more capabilities it has.
Standard 4: Patient Self-Management Support
  1. Assesses language preference and other communication barriers – All the EHR has to have is a place for you to document language, translator and health literacy status. It would be best if these were structured data fields, because sooner or later, they will require you to report on these things.
  2. Actively supports patient self-management** - In addition to your goal oriented care plans and registries, you should have a quality Patient Portal where you can make all this information, along with education materials, available to the patient and his/her family. While most EHRs have Patient Portals now, you need to make sure that they are not just a web page for patients to pay bills and request refills. Whether your patients will use the Portal, or not, is a completely different question.
Standard 5: Electronic Prescribing
  1. Uses electronic system to write prescriptions – An EHR certified to work with Surescripts is necessary for Meaningful Use. Here you just need to make sure that the EHR is not just certified by ONC, but also appears on Surescripts’ website and this feature is operational (not all are).
  2. Has electronic prescription writer with safety checks – This is also a Meaningful Use requirement, but it won’t hurt to find out if the EHR uses a reputable source for drug and allergy alerts, such as First Data Bank, Medispan or Multum.
  3. Has electronic prescription writer with cost checks – Again, check the Surescripts website to make sure that the EHR is certified for Formulary checks (not just sending prescriptions electronically).
Standard 6: Test Tracking
  1. Tracks tests and identifies abnormal results systematically** - A nice dashboard, with sortable columns and color coded abnormal indicators should be standard in any EHR you are considering. This should also be actionable with respect to being able to sign-off and inform patients and staff on further actions right from the dashboard.
  2. Uses electronic systems to order and retrieve tests and flag duplicate tests – This is the dreaded CPOE. Note that it requires additional intelligence in checking to see if the tests you are about to order are duplicative. This is not a simple task and very few ambulatory EHRs have this feature. Choose with care and beware the endless stream of possible alerts.
Standard 7: Referral Tracking
  1. Tracks referrals using paper-based or electronic system** - Many EHRs will allow you to fax referrals from the application. Some will allow electronic transmission to providers using the same EHR or will have interfaces to hospital systems for transition of care. The upcoming Direct Project standards may facilitate this functionality. You should inquire about the EHR vendor’s plans, and capabilities to support implementation of emerging standards at short notice.
Standard 8: Performance Reporting and Improvement
  1. Measures clinical and/or service performance by physician or across the practice** - If you have that nice Registry discussed above, you should be able to run any reports you want by physician, by date, by patient group, by practice, by specialty, by insurer, etc.
  2. Survey of patients’ care experience – Although, you could do this on paper at check-out, this should be an option on your Patient Portal, which will allow you to measure and report results.
  3. Reports performance across the practice or by physician ** - Same as element A above, only now you have to share those reports with others.
  4. Sets goals and takes action to improve performance – Not much an EHR can do here, but the Registry should be able to provide reports substantiating improved performance.
  5. Produces reports using standardized measures – Not sure why the repetition on reporting, but Meaningful Use has a host of required measures as well. Make sure your EHR can actually deliver on all 44 measures, plus whatever else you may want to measure. Some certified EHRs only have capability to deliver the minimum 6 NQF measures allowing you no freedom to choose what you want to measure, or report on. This too is part of the Registry.
  6. Transmits reports with standardized measures electronically to external entities – Several EHRs have Registries that are certified by CMS to submit quality measures electronically. The standard for reporting will be changing soon, and as with interoperability in general, you need to be convinced that your EHR vendor has the resources and ability to roll with the punches.
Standard 9: Advanced Electronic Communications
  1. Availability of Interactive Website – This is your Patient Portal, which needs to allow patients to input requests, data and generally communicate with the practice.
  2. Electronic Patient Identification – This could mean a user name and password (or something more exotic, if you choose) for your patients to access the portal or it could refer to a unique patient identifier in the EHR. Either way, this is not an issue.
  3. Electronic Care Management Support – Everything you do every day will satisfy this element, if it is done in an EHR.
To summarize this litany of standards, if you have any interest in NCQA PCMH recognition, the main functionalities to look for in an EHR, in addition to ease of use and affordable pricing, are a comprehensive Registry with excellent reporting abilities, a flexible Patient Portal, quality clinical content from reputable sources and vendor ability to sustain new standards and regulations, particularly those related to health information exchange. If you want to provide your patients with a compassionate and caring medical home, where they feel safe and well cared for, you will need a different set of “tools”, but perhaps technology can help a little.

Friday, November 26, 2010

The Sound Barrier in Health IT

The October issue of JAMIA sports an article titled “Health information technology: fallacies and sober realities” (thank you “pcp” for bringing it to my attention). The authors, who are obviously concerned about the shortcomings of HIT, are attributing much of the current unsavory situation to widely spread misconceptions regarding HIT design, deployment and utilization. Two to three years ago this article would have been correct in assuming that the salient points it raises are indeed fallacies. Today, you would be hard pressed to find many in the HIT industry, physicians in particular, who would disagree with most of the contents excepting perhaps the final conclusion, but more on that later. First, let’s quickly summarize the points under consideration:
  • Safety must be a consideration when deploying large scale HIT systems and just like other medical devices are tested and supervised to ensure patient safety, EHRs need some form of regulatory oversight.
  • HIT is lacking in usability and cognitive support for clinicians. Both clinicians and usability experts need to be involved in building HIT and extensive research is still needed.
  • Users are not always at fault for mishaps and adverse events.
  • Medicine is a complex field and HIT should reflect that.
  • Paper cannot and should not be completely eliminated.
  • Success of HIT should be measured based on health outcomes, not adoption rates.
  • If you build it, they will not necessarily come unless the benefits accrue to them directly.
  • HIT should be designed for collaboration.
Granted this is a very terse summary, but I believe it is sufficient, considering that much of the above has been hashed, rehashed and widely debated since the advent of Meaningful Use in all its glory. Since the article was authored by health informatics folks, the conclusion is that “Foundational cognitive and human factors engineering research and development are essential to better inform HIT development, deployment, and use”. To emphasize the point, the article draws an analogy to aviation and quotes a 1947 article addressing the complexities found in an airplane cockpit and the need to apply “psychological data and research techniques” and “the necessity for designing the machine to suit the inherent characteristics of the human operators”. And the article goes on to remind us that “In the more than 60 years since that publication, commercial aviation has become very safe. While it may not take 60 years for HIT to become as safe, if we do not change from our current course, it never will be”. Here is where I part ways with the JAMIA authors.

Guess what else happened in 1947? Chuck Yeager piloting his Bell XS-1 recorded a 361 m/s speed and officially broke the Sound Barrier. Less than two years later, the first commercial jet airliner, the British Comet, took to the skies and eleven years, almost to the day, after Captain Yeager’s breakthrough, the Boeing 707, the most enduring jetliner in history, made its first transatlantic service flight. The aviation industry was immersed in a whirlwind of innovation. Computers began their ascent to the clouds during WWII as rudimentary calculators. By the late 1970s, the first “electric jet”, the F-16, came with a completely computerized “fly-by-wire” control system. About the same time, “glass-cockpits” consisting of digital displays began to replace the conventional analog instruments in commercial cockpits. Although the driving reason for glass cockpits was their relative light weight, there were great hopes that computerized displays will increase flight safety and reduce pilot errors.

What does all of this have to do with Health IT? It seems currently fashionable to compare health care to aviation. First the checklists of Dr. Gawande and now improved safety as afforded by the introduction of computers. If we are going to make such comparisons and derive lessons learned, perhaps it would behoove us to understand both aviation and health care equally well*. There is no question that flight safety has improved by leaps and bounds in the last 60 years, but this is mostly due to new technologies, new materials and better design tools for building and testing aircraft. In a similar fashion health care has improved in the last 60 years by technology advances, some of which involved computerization, such as CT scans, laparoscopic devices, pharmaceuticals  and a myriad of other high-tech “tools and die” for physicians. Many diagnoses that spelled certain death 60 years ago are fully curable, or at least manageable, today.

The best aviation comparison for Health IT is the introduction of digital displays in the cockpit. Just like EHRs, glass-cockpits are means to distill vast amounts of information and present them to the user in a way that maximizes efficiency and facilitates better decision support. And just like EHRs, digital instruments from different manufacturers vary drastically in appearance and behavior. Basically, glass-cockpits are to analog flight instruments what EHRs are to paper charts.  Unlike the EHR industry, the aviation folks, and NASA in particular, have engaged in methodic and rigorous human-computer interaction research and applied the results to digital flight controls, although according to the Federal Aviation Administration (FAA), much more is needed:
  • “Not all airplane and avionics designers have considered the pilot-machine interface by using good human factors practices. General aviation needs airplanes that are intuitive to operate, requiring as little training as possible”.
On March 10, 2010, the National Transportation Safety Board (NTSB) published the results of its safety studies regarding glass-cockpits in small aircraft and here are the findings.
  • The statistical analysis found that for 2002–2008, light single-engine aircraft equipped with glass cockpit displays experienced lower total accident rates—but higher fatal accident rates—than the same type of aircraft equipped with conventional analog instrumentation.
  • Accident pilots flying glass cockpit equipped aircraft were found to have higher levels of pilot certification and more total flight experience than those flying conventional aircraft.
  • In addition, the FAA has no specific training requirements for pilots operating glass cockpit-equipped light aircraft. The lack of equipment-specific training requirements from the FAA results in a wide range of initial and recurrent training experiences among pilots of glass cockpit aircraft. With the exception of training provided by airframe manufacturers with the purchase of a new aircraft, pilots must currently seek out and obtain equipment-specific glass cockpit training on their own.
  • The results of this study suggest that the introduction of glass cockpits has not resulted in a measurable improvement in safety when compared to similar aircraft with conventional instruments. The analyses conducted during the study identified safety issues in two areas:
    • The need for pilots to have sufficient equipment-specific knowledge and proficiency to safely operate aircraft equipped with glass cockpit avionics.
    • The need to capture maintenance and operational information in order to assess the reliability of glass cockpit avionics in light aircraft.
Sounds familiar? Turns out health care and aviation are in the same boat when it comes to computerized display/records. This is not to say that human-computer interaction and other cognitive studies are not worthwhile, but the results will only be incremental until the final Sound Barrier is broken. Humans and computers must become able to verbally exchange information. Instead of displaying data on a multitude of colored screens and issue flashing warnings and alarms, the computer should just distill all the digital data and say “You have 10 seconds to pull up or you will crash”, and alternatively, “You are prescribing a lethal dose for this patient. Do you wish to continue?” If you find this slightly delusional, just ask Captain James T. Kirk of the Starship Enterprise.

*Disclosure: I am an Aeronautical Engineer by education and Health IT professional by personal choice.

Sunday, November 21, 2010

Health IT and the Other Disparities

On October 18 2010, Dr. Blumenthal published a letter to EHR vendors titled "Health IT and Disparities"  urging them to “include providers who serve minority communities in their sales and marketing efforts”. Reiterating the assumed benefits of Health IT to both quality of care and efficiency of care delivery, the National Coordinator for Health Information Technology stressed the importance of EHR vendors working together “to provide EHR adoption opportunities for physicians and other healthcare providers working within underserved communities of color”. This is obviously an important and welcome appeal. Physicians who provide care for impoverished minority communities usually lack the means to purchase EHRs and perhaps some EHR vendors will heed Dr. Blumenthal’s request and make special arrangements for these doctors and their clinics. The stimulus incentives may also help. But how about those who serve equally impoverished populations and are practically barred from incentives?

In my home State of Missouri there are about 350 Rural Health Clinics (RHC) serving a state which with very few exceptions is one big Medically Underserved Area/Population (MUA/MUP) which is a geographical area or a population designated by the Health Resources and Services Administration (HRSA) as having: too few primary care providers, high infant mortality, high poverty and/or high elderly population. For the uninitiated, RHCs are designated by CMS and have to meet certain requirements. The practice has to be located in a rural area and it has to provide team care, which is all the rage now, meaning that a Nurse Practitioner or a Physician Assistant and a Certified Nurse Midwife have to be on premise and team up with the physician in providing patient care. RHCs can be independent practices or they can be owned by rural hospitals. Either way RHCs are paid by Medicare differently than a practice without RHC designation. RHCs are required to submit reports of their operational costs and their total number of visits. Based on these two parameters the reimbursable cost per visit is calculated by Medicare. The entire process is complex and subject to rules, regulations and caps. The main point here is that RHC providers are not reimbursed according to the regular Medicare physician fee schedule and therefore will be unable to receive EHR incentives under Medicare. A few RHCs may qualify for Medicaid incentives, but in most cases they don’t have the prerequisite 30% Medicaid patients.

It all started with the HITECH Act where Medicare incentives to Meaningful Users are calculated based on allowable charges for “covered professional services”, which are defined in Section 1848(k) of the Social Security Act as “services for which payment is made under, or is based on, the fee schedule established under this section”, i.e. RBRVS. RHCs are reimbursed for most services on a cost basis as explained above, effectively barring them from qualifying for meaningful incentive amounts. Several public comments to the CMS NPRM on Meaningful Use addressed this very issue, but all were dismissed in the Final Rule by simply restating that “RHC services furnished by an EP are not considered covered professional services for purposes of the Medicare EHR because they are not billed or paid under the physician fee schedule”. While I do understand the bureaucratic difficulty in differentiating between the RHC Medicare claim form (UB04) and the form used by other practitioners (CMS1500), I don’t quite understand how RHC services are not “covered”. The even more perplexing fact is that CMS went out of its way to incentivize providers practicing in Health Professional Shortage Areas (HPSA) by adding 10% to their Medicare incentives, but at the same time decided to exclude a large portion of those providers just because they are using a different form for submitting claims to Medicare. It is worthwhile remembering that these same clinicians were also excluded from PQRI incentives and later from e-Prescribing incentives for the same exact reason.

Like most rural providers, RHCs face serious obstacles in Health IT adoption. Health IT vendors find it difficult to reach rural providers and rather expensive to provide them with services mainly due to simple logistics such as distance from airports and lack of physical concentration of customers. Most rural providers are strapped for cash anyway and reliable IT support is not as easily found as in urban areas. In many rural counties broadband is not available and even when it is available, rural hospitals, pharmacies, labs and diagnostics centers are rarely using HIT and are almost never able to exchange clinical information making the immediate value of an EHR unclear. For those RHCs that are owned by rural hospitals the prospects are even less attractive. There is very little reason for the hospital to invest in ambulatory EHRs if no incentives are expected, particularly since more often than not the hospital itself is light years away from having a qualifying inpatient EHR.

According to the Kaiser Family Foundation, an average of 21% Medicare beneficiaries reside in rural areas, with 12 States having over 45% rural Medicare residents, many of whom are served by RHCs. In Colorado, for example, the estimates are that 40% of Medicare beneficiaries receive care in an RHC. When you combine all factors, there is a veritable digital abyss forming between elderly Americans residing in the countryside and the rest of us.
It’s not too late, and it shouldn’t be too difficult to fix this, but rural America, and its few remaining doctors, need a champion in Washington… Dr. Blumenthal?

Sunday, November 14, 2010

The Ethics of EHR Vendors

Last week the American Medical Informatics Association (AMIA) released a position paper titled “Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force”.  The paper shines a bright light on the alleged contracting practices of EHR vendors and their notorious “hold harmless” clauses, which indemnify the EHR vendor from all liability due to software defects, including liability for personal injury and death of patients. What this means in plain English is that if a software “bug” or incompetency caused an adverse event, and if you (or your hospital) are faced with a malpractice suit, the EHR vendor cannot be named a co-defendant in that suit and you cannot turn around and bring suit against the vendor for failure to deliver a properly functioning product. The AMIA paper also asserts the existence of contractual terms preventing users and purchasers from publicly reporting, or even mentioning, software defects, including ones that may endanger patient safety. The AMIA report goes on to challenge the ethics of both buyers and sellers engaging in such contracts, with an emphasis on the EHR vendors’ primary responsibility to shareholders and the bottom line in general.

As expected, the authors call for Government regulation of HIT products and processes and suggest that contracts should, of course, reflect a shared responsibility between vendors and customers and while public reporting should be allowed (or required) for certain types of software defects, users should be mindful of the vendor’s intellectual property. The interesting portion of the report is the rather novel recommendation for formal Ethics education amongst vendors and purchasers. Presumably, vendors and their customers need to be taught the difference between right and wrong and need to be informed that placing corporate profits (or personal comfort) ahead of patient safety is indeed wrong and therefore unethical. To borrow from the Windows 7 phone commercials, “Really?

If you ever signed a purchase or service contract, you should know that the opening bid from the seller is just that: the opening bid in the negotiating process to follow. EHR contracts are no different. The initial contracts presented by vendors may contain some, all or none of the following:
  • Hold harmless or most often limited liability, for personal injury and death resulting from use of the software. The assertion is frequently made that the software is not intended as a diagnosis and treatment tool and is not a substitute for professional judgment. Many times this clause is accompanied by multiple disclaimers of warranties regarding the accuracy and veracity of the clinical content and decision support provided by the software. The purpose of these terms is to insulate the vendor from malpractice suits. It would be very tempting for a plaintiff, who is usually poor and indebted, to include someone like McKesson or GE in the lawsuit. Juries have even less compassion for corporations than they have for “rich” doctors. The hold harmless clauses, and I have not seen too many, should be removed and the limited liability should be increased from the customary six to twelve months of support fees, to a more significant dollar amount.
  • Restrictions placed on the buyer from mentioning the software product name in any format for advertising, marketing or any other purposes, without written permission from the seller. This clause is ridiculous and I presume that’s where the “gag” rules on defect disclosures come from, since I have never seen an explicit line item to that effect. The rather humorous fact is that the vendor usually reserves the right to use the buyer’s name for publicity and marketing purposes. This particular clause should be completely removed, or at the very least changed to only disallow misrepresentation of the relationship between the buyer and the seller.
  • Most often the software is warrantied to perform according to the product manuals for ninety days, or not at all, and it is never warrantied to be free of defects or work without interruptions. Would you buy a car with a similar warranty? In all fairness, no software vendor can warranty that the product is “bug free”, because there is no such thing as bug free software. However, respectable vendors in the software industry offer Service Level Agreements (SLAs) outlining processes and timelines for addressing reported issues and financial penalties to the vendor for failing to do so. This brings us to the next salient point.
  • Some initial EHR contracts lack any mention of SLAs. There may be descriptions of help desk availability, but no commitments to time frames for resolution and definitely no penalties for non-adherence to SLAs. The buyer must be able to negotiate those into the contract or look elsewhere for software and services.
Contracts containing terms as those described above are examples of a typical purveyor of goods and services trying to make a “good deal” and the buyer’s job is to bargain the terms down to what would be a “good deal” for the buyer, with the final result being somewhere in the middle. Ethical considerations would come into play only if the vendor is knowingly proposing to sell goods that will harm patients, and the buyer knowingly agrees to keep this information secret in return for financial concessions from the vendor, and some of the more vocal opponents of HIT would argue that this is indeed the case. But even then, I seriously doubt that such collusion to disregard patients’ safety for pure monetary gain is a result of vendors and their customers not knowing the difference between right and wrong, or lacking a sound education in the realm of Ethics. Nothing short of legislation and regulation will stop this blatantly predatory behavior if it indeed exists, and I doubt it does.

I would like to submit that there is indeed a need for education, but of a very different nature. Whether the vendor and purchaser agreed to keep issues secret or not, the bugs or defects that can potentially harm patients are the creation of software developers on the bottom of the corporate totem pole. These are not unethical folks and have nothing to gain from cutting corners and endangering people’s lives. But just like physicians sometimes make mistakes, programmers do too and what is most frustrating here is that they don’t even have to make a mistake in order to create a clear and present danger in the software. These mostly young and healthy professionals know very little about the practice of medicine and in many cases have no overarching understanding of the product they are helping to build. They may be experts at the tiny piece they were tasked to develop, but few if any have a grasp of the dire consequences caused by an incorrectly sorted list of medications, for example. The bigger the shop and the more geographically dispersed, the bigger the problem becomes. It is tempting to argue here that EHRs should be designed and built by clinicians, like VistA supposedly was. While clinicians should have much input in design and particularly in acceptance testing of EHRs, it is not economically (or socially) feasible to have hundreds of MDs sitting in little cubbies, writing code for a living. Instead, EHR vendors should indeed engage in educating their workforce, including the most junior developers, on how medicine is practiced. They need not become expert diagnosticians, but it would be great if medical software developers would be required to take rotations (similar to residents) at implementing and supporting the software, preferably at customer sites, before being allowed to touch the code.

Success is brought on by doing the little things right. While there may be some ethically challenged industry captains engaging in questionable contracting practices, the armies of people who do the actual work and create the actual products are by and large capable of telling right from wrong and need no lectures on Ethics. What they need is for someone to compel their employer to invest in their professional education so they are able to do the millions of little things right. And I have seen enough young software developers to know that they really, really want to learn and do the right thing.

Tuesday, November 9, 2010

Quiz

Below are several random verbatim (vendor name removed) quotes from EHR vendors’ websites or press releases.


Question: What do the following EHRs have in common?


 
ABCD EHR has earned the distinction of receiving ONC-ATCB certification. ABCD is at the forefront of the effort to help providers across the US to become “meaningful users” of EHR and qualify for $44,000 to $63,750 in federal stimulus dollars. The eligible professionals and hospitals can use this certified EHR technology as part of their criteria to qualify for Center for Medicare and Medicaid Services (CMS) incentive payments.

Using our EMR System qualifies you for $44,000 in economic stimulus plan incentives under the HITECH Act. Visit our Stimulus Center.

"EFGH-EHR is meeting all of the requirements for 'meaningful use', which means you will be eligible to get your share of the government incentive with EFGH-EHR".

JKLM announces that the JKLM EMR has been tested and certified under Drummond Group's Electronic Health Records ONC-ATCB program (ONC-ATCB EHR 1234567890). Drummond Group Inc. is an ONC authorized testing and certification body (ONC-ATCB) that provides meaningful use certification for EHR systems and applications. When a complete EHR system or EHR module(s) is certified by Drummond Group, the eligible providers and hospitals can use this certified EHR technology as part of their criteria for qualifying for Center for Medicare and Medicaid Services (CMS) incentive payments.

NOPQ, (www.NOPQ-website.com), one of the nation's top independent medical healthcare information technology companies, has received an EHR module certification deeming the electronic health record (EHR) software capable of enabling providers to meet the Stage 1 meaningful use measures required to qualify for funding under the American Recovery and Reinvestment Act (ARRA).

Answer: None of the certified products above, in their current state, will qualify you for Government incentives, since none of these products have been certified as a “Complete EHR”.

If you are shopping for an EHR and if you are interested in qualifying for incentives for Meaningful Use, please visit ONC’s listing of certified HIT products at http://onc-chpl.force.com/ehrcert . Once there, make sure that your selected EHR has “Complete EHR” specified in the “Product Classification” column. Anything with “Module” in that column will require that you purchase additional products to qualify for incentives. Make sure that the version you are about to purchase matches the entry in the “Product Version #” column as well.

Additional word of advice: Even if the EHR you are considering is certified as “Complete EHR”, ask to see a detailed demo of each one of the 25 Meaningful Use Stage 1 criteria and make sure that all the functionality you are seeing is included in the price you were quoted.

As usual, Caveat emptor is the name of the game…..

Sunday, November 7, 2010

It’s the Network, stupid

So November 2nd came and went and the GOP has done well and media of every form and shape is trying to predict the fate of health care reform. Uncertainty looms large over the Affordable Care Act, but there is one tiny bit of it that has gathered enough momentum during the last two years to be unstoppable and irreversible. Health Information Technology (HIT) has made it over the tipping point and its dependency on Government support is no more.

The skeptics and those opposing HIT in general, will be pointing out that if the new-and-improved Government finds a way to reverse the flow of billions of dollars initiated by the HITECH act, all activities will come to a grinding halt. No more Meaningful Use and no more State HIE and no more RECs evangelizing for adoption of EHRs and, most importantly, no more cash incentives for physicians to buy those pesky EHRs. Surely all health care providers will turn back to their voluminous paper charts with a sigh of relief and a gleeful “I told you so”. And perhaps some will, but not many and not for very long.

With or without Government involvement, the health care fundamentals remain unchanged. Health care is too expensive for most Americans and anyone selling health care services will have to find a way to manage costs down if they are to stay in business. Hospitals and large systems have recently made astronomic investments in HIT. These cannot be ripped out and written off as easily as one may imagine. The logical path for these large providers is to compensate for potential loss of incentives by finding other returns for their investments. Perhaps CPOE and reporting of convoluted quality measures will be taking a backseat to measuring efficiency and cost-effectiveness. Since keeping folks healthy in the first place seems cheaper than managing diseases and complications, perhaps longitudinal health management and coordination of services will become a major priority. To keep profitability up in a market where most people are non-consumers (the GOP way), or a highly regulated low-margins market (the Democrats way), health care providers will be competing for every bit of market share through mergers and consolidations and the creation of Networks. And Networks are powered by HIT.

The Medical Society of Delaware was founded when George Washington was President. Last week, the Society announced the creation of a statewide Network connecting all its members to Delaware patients. Every Delaware resident is provided with free access to a Personal Health Record (PHR) supplied by RelayHealth and in collaboration with LabCorp, Delaware physicians will be sharing lab results with their patients and each other. Delaware is also home to the first operational State Network (2007), the Delaware Health Information Network (DHIN), which connects over 60% of Delaware’s physicians with hospitals, labs and patients and provides a variety of clinical information exchange.

Michigan is kicking off its brand new statewide Network as well. The Physicians’ Organization of West Michigan (POWM) in collaboration with the University of Michigan Health System is creating the Physicians Organization of Michigan (POM), thus “allowing independent physicians to stay independent, rather than at the behest of a large hospital system”. POM is combining resources from two very large organizations to provide physicians and physician groups across Michigan with “access to resources, opportunities and support that will allow them to remain independent while adapting to the new health care environment”. This of course includes “access to shared technology systems and a framework for measuring and improving the quality of the care they provide”.

On the vendor side, eClinicalWorks (eCW) unveiled its 100millionpatients.com Patient Portal to complement the Peer-to-Peer (P2P) community Network spanning all eCW users, and to some degree practices that are not eCW customers. Within the eCW P2P Network, physicians can exchange referrals (summaries, results and all sorts of documents), schedules and demographics, with a click of a button. The new PHR will presumably give patients similar cross Network access. And then, there is Surescripts, with its Network of over 150,000 prescribers, 85% of pharmacies and 65% of patients. Recently Surescripts decided to expand beyond prescriptions and make its Network available for exchange of a wider variety of clinical information. This is a national Network and judging by its current practices, Surescripts will be offering a completely open and standards based Network to all HIT vendors, and their customers, wishing to connect and exchange clinical information. Another prominent Network operator, NaviNet, has recently announced its intent to embed a fully certified EHR in its largely administrative Network of hundreds of thousands of providers.

There are many more such Networks being created, extended and deployed all over the country. What do all these Networks have in common? They are not supported by Government funds. These are private investments in clinical information exchange. Most of these Networks can afford to provide connectivity to both patients and providers for nominal prices, or completely free, since their revenues will be coming from secondary sources, such as referrals, payers, pharmacies and data mining. If the financial HITECH fountainhead is shut off by the new realities in Washington (not very likely), or throttled back somewhat (probably), these market driven Networks will be only minimally affected. HIT is here to stay. For all those who are skeptical or downright opposed to HIT, please look back at each and single technology in use today and understand that technology only moves in one direction: forward.

Saturday, October 30, 2010

Dismantling the Cottage Industry

Last week I went to see a doctor about an EHR. Dr. Greene (not his real name) is a typical solo primary care physician in a typical small town in the typical middle of nowhere. Four hours from the closest airport and miles and miles of winding roads, cow pastures and corn fields away from medical centers of excellence. Dr. Greene is in his late fifties and has been practicing medicine for over thirty years in the same location. He works six days per week and missed “two and a half” days of work since he hung his shingle up and never missed a Rotary Club luncheon. Dr. Greene is planning on practicing for ten more years and now, he wants to go electronic.

Dr. Greene’s practice is located in a small and spotless one-story building with large windows and an open floor plan. We sat down at a white laminate round table in the kitchen during his lunch break. His wife of many years is his office manager and the only other employee is a nurse who doubles as front office receptionist. His shortest appointment is for 30 minutes and new patients, who are scheduled for 1 hour, come at the end of the day just in case it takes longer than planned. His notes, written on special gold colored paper in nicely rounded cursive font, are concise and neatly organized by visit date. Like most doctors who use paper charts, he doesn’t code his visits. He checks diagnoses and procedures on a sparse super-bill devoid of any numbers. His wife and office manager takes it from there and all his claims go out electronically every day.

Dr. Greene collects 99.6% of his charges and he never used a collection agency and he never will. Wait a minute…. This is impossible. Insurers deny payments all the time and they certainly don’t pay what you bill out. Not to mention that patients are not very quick to pay either. How can you collect 99.6% of charges? How about allowables and adjustments and writeoffs and all other administrative nightmares that are part and parcel of a medical practice? Dr. Greene walked out of the kitchen and returned with a piece of paper he picked up at the front desk: his fee schedule.

Dr. Greene’s fee schedule was neatly typed on a letter sized pink sheet of paper and carefully encased in a clear plastic protecting sleeve. The fee schedule contained about fifteen procedure codes, mostly E&M codes for various office visits. He doesn’t do any procedures in the office and if he does an “EKG or some other simple thing”, he doesn’t charge separately for it. The fee schedule had two columns for each code; the Medicare allowed fee and the actual fee he charges all his patients. I had to look several times at the column headings to understand – Dr. Greene charges less than Medicare is willing to pay him. For the most common visits, he charges a lot less than Medicare will pay. He bills these lower charges out to Medicare, to all private insurers and to his cash patients. Why????

Dr. Greene was laughing and Mrs. Green was smiling at my total lack of understanding. I guess city folks are not so bright after all. For Dr. Greene this is a matter of principle. It is an entire philosophy. This is about fairness and honesty. His patients are his neighbors and he knows all too well that most cannot afford to pay the Medicare deductibles. He charges what people can pay and he makes it simple, straightforward and fair. His fee schedule is displayed at the front desk. In return, his patients pay their bills promptly. Fairness in small communities is usually reciprocated. Medicare and commercial payers, probably assuming he is mad, are quickly paying his claims just like a quarterback quickly snaps the ball to avoid a challenge. That’s how you get 99.6% of your charges collected with very little overhead. And, no, he is not at all interested in changing things. He is making a very nice living, thank you.

Dr. Greene wants an EHR. Why? Because he wants to receive lab results electronically from the little hospital down the street, and because he wants to use templates. Templates??? You mean you want to click on boxes instead of writing those beautiful golden notes? He thinks a dozen or so customized templates would make him more efficient and allow him more time with his patients and perhaps he can go home a bit earlier too. He wants to send prescriptions to pharmacies and not have to write down the medication list each time. No, he doesn’t want to create documentation for higher billing codes. And he doesn’t want to be left behind. Dr. Greene, unlike some of his colleagues in town, has no plans of running away and retiring early in the face of new challenges. He will get an EHR and he will exchange clinical information and he will advance with the times. He will be exploring quality improvements and medical homes and even accountable care organizations. Dr. Greene knows that EHRs slow you down and are well positioned for improvement, but he also knows that his grown children, who are themselves physicians, will expect an electronic office if and when they return to their hometown to continue the tradition. There was a faraway dreamy look in his eyes now. Lunch hour was over and there was one patient in the waiting room.

For all the pundits and the health economics experts, and for the political activists on either side, who are actively trying to dismantle our health care cottage industry and reconstitute its remains into large corporations of efficiently employed physicians, this is what you are attempting to dismantle - Dr. Grdene, and the thousands of others like him who practice medicine four to five hours away from a major airport beyond miles and miles of cow pastures and fields of corn.

Sunday, October 24, 2010

o-Patients

If you read this, you are probably familiar with the e-Patient concept. If you read this, you are most likely well educated, have an interest in health care and probably strong opinions regarding health insurance reform, and are very aware of the recent Government push for Health Information Technology adoption. Most people in this country will not be reading this, and most people, while aware of the political aspects of health reform, have no idea that their days of being just patients ended, and they ought to behave as consumers now, and preferably as e-Patients. These are the other patients, or for short o-Patients.

When Consumer Driven Health Plans (CDHP) made their debut, they promised to empower me as a consumer and allow me to make my own decisions on how to spend my health care dollars. I thought this was wonderful, until I realized that as an empowered health care consumer, I now have to spend money I didn’t have to spend before and I have to make decisions about forgoing treatments based on their costs. Empowerment usually translates into additional expenditure of both money and time and a requirement to make hard choices where none were needed before. I would have chosen to decline this empowerment offer, but unfortunately, since my employer was the decision maker, I was not empowered enough and my empowerment became mandatory.

I am now observing the e-Patient and Participatory Medicine movements. These also want to empower me to participate in my own health care. I am supposed to become “equipped, enabled, empowered and engaged” in my own health care. After spending about 20 years in various academic institutions, I think I am pretty well “equipped”. I don’t know what “enabled” means in this context and my CDHP experience makes me very suspicious of "empowered". Just like most people, except of course, the poor, uneducated and elderly, I did search for health information online, and I would like access to my family’s medical records, primarily so I can print out a school immunizations list without having to pay $10 per page. As to “engaged”, engagement is gradually being defined by the Government, the e-Patients lobby and various other interests, as active involvement in maintaining your Electronic Health Records (EHR), including full ownership and interpretation of “raw data” outside a provider organization. I may be equipped, but I am not willing to dabble at the practice of medicine and I refuse to become “engaged” in this manner. I have no desire to spend countless hours aggregating data from various providers, analyzing it (or having it analyzed), proof reading everything and becoming my own Medical Home. But then again, I am not big on “do-it-yourself”. I’d rather leave accounting to accountants, plumbing to plumbers and medicine to physicians. I suppose this makes me an o-Patient, along with the vast majority who is neither equipped, nor enabled and not even remotely inclined to actively manage their medical records at all times.

If you read this, you should also be aware that the Government is proposing to pay providers for adoption of EHR software and Meaningful Use of it. A significant portion of that Meaningful Use is making medical records available to patients for viewing and even downloading through Blue Buttons. This is a good thing and technically rather cheap and easy to accomplish. Josh Seidman PhD has a beautiful and touching story on how availability of medical records online allowed him to participate in his father’s care from afar. But this simple and powerful achievement doesn’t seem to be enough. e-Patients and their innovative startup supporters want much more included in Meaningful Use, and Meaningful Use is quickly becoming the blueprint for our health care delivery system. Meaningful Use includes no provisions, or requirements, for primary care physicians to aggregate and manage medical records for their patient panels, but it does include an ever increasing array of functionality that enables patients to do the same. Providers are not paid to aggregate medical records and patients are touted as the ultimate free resource. Empowerment is looming large.

On April 20, 2010, the Office of the National Coordinator on Health Information Technology (ONC), who is defining Meaningful Use of EHRs and therefore also redefining how medicine is practiced in the U.S., held a public hearing on Patient/Consumer Engagement. The presenters were the usual learned luminaries that you would expect; EHR vendors, silicon chip manufacturers, academic institutions, other research fellows, health care corporations, a couple of community services representatives, innovative startup companies and of course a famous e-Patient. There were no o-Patients in the room. ONC heard exactly what they wanted to hear. It is imperative to allow patients access to their medical records. But they also heard, from the e-Patients representative, that patients need EHRs to have “open APIs” so data can be extracted in any format they wish. I couldn’t help but wonder how many patients or consumers are familiar with the term “open API” and how would an “open API” serve someone like Josh Seidman who just wanted to read the medical records.

On June 5, 2010, the ONC had another public hearing. This one was about using Health Information Technology to eliminate disparities. I was very hopeful that this hearing would be about o-Patients, and it was. The participants were highly educated, very well meaning folks who dedicated their careers to helping the segment of o-Patients who is very ill equipped to join the information age. Along with reiteration of the dubious calls for extracting data from providers’ EHRs, ONC heard some serious concerns regarding quality and availability of HIT in small practices which serve most Medicaid o-Patients, and perhaps these discussions were part of the reason for Dr. Blumenthal’s recent appeal to HIT vendors to include providers serving minorities in sales and marketing efforts. Just like the previous hearing, this public meeting included no o-Patients and no practicing physicians.

So here is a suggestion for ONC’s next public hearing. If you really want to understand what people need and want, why not ask them? When you leave home in the morning take a bunch of public hearing invitations with you. When you stop to fill gas, give an invitation to the attendant. As you pay for the latte at your favorite coffee shop, hand an invitation to the barista. When you cross the park and notice the two older gentlemen warming up on a bench, hand each one an invitation. Hand one to your administrative assistant too. When you go out for lunch, invite your waiter or the little Italian Restaurant owner himself. If you take a taxi there, invite the driver. Assuming you work long hours, you should be able to run into the cleaning crew. Give each one an invitation. If you get a speeding ticket driving home, invite the officer. Finally, when you stop at the grocery store for milk, distribute the remaining invitations to the young checkers and the elderly baggers.

My guess would be that none of these folks will demand “open APIs” or “data extractions” and most importantly, none of these o-Patients will want to be forcibly empowered to take over the active management of their medical records. As long as e-Patientship is optional for those interested, it is a very positive and inspiring phenomenon. We do need to keep in mind though, that all those “open APIs”, “data extractions” and “untethered PHRs” cost money and consume physicians’ time. Since I am not aware of any offers from e-Patients and/or data-seeking startups to pay for actual data collection and extraction, perhaps it would be wiser at this point to spend our scarce resources on health services with broader appeal and better utility. The day the medical profession relinquishes, or is forced to relinquish, its last shreds of responsibility for any semblance of care coordination and continuity of care, and farms it all out to freshly "empowered" unsuspecting patients and their “untethered PHRs”, will be a sad day indeed.

Sunday, October 17, 2010

HIE Guide for the Perplexed

HIE stands for Health Information Exchange. Sometimes the term HIE is used to describe the act of exchanging health information, sometimes HIE is used to describe the infrastructure which enables the exchange to occur and sometimes HIE is used to describe an organization that owns the infrastructure which enables the act of health information exchange. HIE (the act) is supposedly the holy grail of Health Information Technology (HIT) and the enabler of “an EHR for every American by 2014”, which in turn, will bring about better health care at lower costs and, by leveling the playing field, will reduce disparities in care.

The Government, through ONC, has awarded over $547 million to various States to create regional HIE (organizations). The fledgling new State HIEs (the organizations) are busy screening and purchasing HIEs (the platforms) and defining the rules of their local HIE (the act). There are several HIE (platform) vendors, notably Medicity and Axolotl (recently acquired by Ingenix), but even Microsoft and IBM are trying to make inroads into this fairly new market. In a parallel process, ONC is busy defining national standards and regulations for HIE (the act).

There are two basic models for any information exchange and HIE (the act) is no different.

The Centralized Model – All information creators/editors/contributors push their content to a centralized repository, preferably in real time, and all users/readers pull the information on demand from said centralized repository. This is the infamous “database in the sky” which houses every American’s medical records. Conceptually, this is the simplest model to understand. The Government will buy enough hardware to set up clusters upon clusters of databases, define the exact data elements and documents to be stored, assign a national identifier to all of us (physicians too) and finally publish specifications for pushing and pulling data securely. Every EHR vendor and medical information supplier (such as labs and pharmacies) will build the necessary web services and integrate them in their technology and we will all live happily ever after. However, other than the obvious monumental technology challenges involved in maintaining such infrastructure, Americans tend to experience significant discomfort with the concept of Uncle Sam having unfettered access to so much personal information and the obvious privacy issues it raises.

The Federated Model
– Health information is maintained where it is created, be it physician offices, hospitals or other agencies of care. Contributors push content to users if they want to and readers pull content from contributors when they need to. The best way to think about this is to compare it to telephony. You call me when you need information from me or when you want to share with me information you have, and I do the same. This of course implies that we speak the same language and know each other’s phone number and if we don’t, we have a way to look it up somewhere. It also implies that we both have an agreed upon method of identifying the people we are discussing, e.g. cousin Jamie is my aunt Sarah’s daughter, not your uncle Bernie’s oldest boy. This model requires something akin to White and Yellow pages for providers, as well as unique identifiers for patients, and an agreed upon method to “make phone calls” or push and pull information.

And then, of course, you can have multiple hybrid models, which are somewhat centralized and somewhat federated. The Government funded State HIEs (the platforms) could be regional databases in the sky, or regional telephony networks with associated directories, both serving as federated super nodes on a national network of networks. The advocates of patient controlled medical records would suggest that PHRs should be the basic units of a federated model and nobody gets to gossip about cousin Jamie except cousin Jamie, who at my request will tell you as much as he/she chooses to tell you.

So what are we building out there? We are definitely not building the centralized national database, that’s for sure, but we seem to be engaged in building a little bit of everything else, and we are not starting from scratch.

Pre-HITECH HIE (the act)

Before Meaningful Use became a capitalized term, there where all sorts of HIEs (the acts) going on. Providers with halfway decent practice management systems (most providers) were sending out almost all claims electronically, receiving electronic remittance and checking health plan eligibility for patients in real time. Most accomplished this wondrous HIE (the act) through claim clearinghouses, such as Emdeon, RelayHealth or Gateway EDI, which have built very sophisticated national HIEs (platforms). On the clinical side, anyone with a Surescripts certified ePrescribe module could send prescriptions to most any pharmacy in the nation, receive refill requests and complete medications lists for insured patients, all electronically with a click of a button. Just like the claim clearinghouses, Surescripts created a national HIE (the platform), complete with provider directories and algorithms to identify patients. The national reference laboratories were not far behind and most physicians with an average EHR could send lab orders and receive results electronically from LabCorp and Quest. A host of regional labs were quickly following suit and hospitals were not far behind. The newest trend consisted of electronic clinical summaries in CCR or CCD standard. These were starting to gain some traction as a means of communication with PHRs, such as Google Health and Microsoft HealthVault and here and there files were exchanged between EHRs. It is important to note that clearinghouses charged physicians only a nominal fee (some were free), Surescripts was free to doctors and so were reference lab interfaces.

Enter HIE (the organization)
 
Although HIE (the act) was occurring, it wasn’t spreading fast enough to meet the 2014 goals, so the Government decided to sow the seeds for organized regional HIE (the act). The first order of business for these State HIE (organizations) is to enable HIE (the act) of prescriptions, structured lab results and patient summaries, which are all requirements for Meaningful Use. Why would they need to do that when physicians are expected to adopt certified EHRs which already have those abilities? For a while now I’ve been puzzled by the National Institute of Standards and Technology (NIST) requirements for ONC certification of EHRs. Unlike the comprehensive CCHIT certification, NIST does not require that a certified EHR be connected to Surescripts and it does not require standard capabilities to interface with national labs. Why not? Because the Government funded State HIEs (organizations) are intended to insert themselves between the physician EHR and Surescripts or LabCorp and later probably claim clearinghouses as well. What used to be a simple point-to-point web service, just turned a bit more complicated, and what used to be free to physicians, will be so no more because HIEs (the organizations) must become sustainable businesses and will charge fees for transactions.

Perhaps it is all worthwhile if these newfangled HIE (organizations) can somehow foster comprehensive national HIE (the act). While State HIEs (organizations) are selecting and deploying various HIE (platforms), using various privacy and security policies and a multitude of directory structures (which may or may not be shared) and various standards of communications, it is expected that all will become federated nodes in the overarching Nationwide Health Information Network (NHIN) which is itself under construction. [I understand that the NHIN is just an incomplete set of specifications, but for some reason, I have this vision of thick, black rubber cables crisscrossing the country.] In the meantime, a more nimble sibling of NHIN, namely NHIN Direct, is also taking shape by proposing to use a completely different and much simpler addressing and transport construct, similar to email, which will allow physicians to send unstructured information to one another, presumably outside the HIE (organization) scope. Concurrently, the historical clearinghouses and Surescripts networks continue to flourish and function as before. In addition to the official State HIE (organizations), there are other private HIE (the act) efforts sprinkled around here and there, which may or may not be inclined to connect to State HIE (the organizations), and some large EHR vendors are starting to run their own proprietary peer-to-peer networks across organizations. Every HIE (platform & organization) is promising “seamless” integration of all these conflicting initiatives.

Epilogue

Long ago and far away, in the miraculous country of Shinar, all of humanity decided to build a tower so tall that it will reach heaven. Recognizing that people united by good communications are sure to succeed, the Almighty, who opposed this particular venture, disrupted work by fragmenting the one accepted standard of communications. Since the StarTrek Universal Translator was not in existence at that time, humanity became confused and the mighty tower was never completed. Thus, to this day, humanity is wondering around this earth perplexed at their inability to build tall enough towers.