Fulfilling the PROMISe

Dr. Larry Weed

A brand new EMR is being rolled out in a midsize hospital. The EMR is exclusively based on touchscreen technology, with devices strategically placed on the floor. It provides concurrent access to medical records for all team members (physicians, nurses, pharmacists, radiologists, dieticians, secretaries) wherever they may be. Patients are also accessing the EMR. They enter their own histories and describe symptoms in detail through the same touchscreen devices. This patient-centered EMR, built by a team of clinicians and technologists working together, is taking a huge step forward in Clinical Decision Support (CDS). Physicians are not only shown differential diagnoses based on what patients and other team members entered into the system, but are also presented with individualized care plans, possible side effects, dosage recommendations and drug-drug-interaction alerts, all referencing evidence available in medical literature. Longitudinal records, test results and narratives are available by problem and by patient, and the response time is never more than half a second between the thousands of screens available. The place is Vermont, and the year is 1970.

Half a century ago, when work on this EMR was taking place, Healthcare IT was on the cutting edge of technology. The Problem Oriented Medical Information System (PROMIS), the brainchild of Dr. Lawrence Weed, was pushing the envelope on every technology from hardware to operating systems, to network communications, database design and programming languages. By the time this government funded project was finally shut down, the PROMIS team dealt with such issues as mass storage, federated or single database, high availability, human interface design and networking between geographically dispersed locations. It will take several decades for the rest of the world to catch up with Dr. Weed’s, now defunct, innovation and produce something like IBM’s Watson software package, which is yet to be adapted and tested in health care. Somewhere, somehow, we took a wrong turn in Healthcare IT, and it wasn’t the much maligned billing influence, since PROMIS from day one, attempted to integrate billing in its software, with no ill effects.

But something of that brilliant era did survive. PROMIS was essentially an early attempt to computerize the Problem Oriented Medical Record (POMR) proposed by Dr. Weed in 1964, which is almost exclusively used today in clinical documentation, and better known as the ubiquitous SOAP note (Subjective-Objective-Assessment-Plan). Practically every EHR in existence today is based on Dr. Lawrence Weed’s SOAP note format. Whether small or large, client-server or browser, free text or all template based, once you open the encounter note, you are presented with the familiar structure of History of Present Illness (HPI), followed by Social, Medical and Family Histories, Review of Systems (ROS), Exam, Assessment and Plan. Since this is perceived to be the heart of the EHR you will find much “innovation” and “secret sauce” added to the electronic SOAP note, with the singular purpose of speeding up documentation and ensuring that the finished note is a proper clinical, legal and financial document. And as most of us know only too well, we are not there yet.

Interestingly, the folks working on PROMIS faced the same hurdles we are facing today, albeit their tools and technologies were pretty much stone-age compared to present day technology. It is fascinating to see how much effort and concern went into selecting just the right user interface, ensuring that response time was measured in fractions of a second and in keeping the system up 24x7 and as error free as possible. For the clinical staff that took the time to enter data through the state of the art user interface of a  Cathode Ray Tube (CRT) monitor with little touch-sensitive strips attached in just the right places, PROMIS delivered serious value. It offered differential diagnoses for each problem, patient specific care plans, collaboration and real time access to medical records. It obviously wasn’t enough though, since the project did get canceled in the early eighties. Today’s EHRs can, and do, offer collaboration and real time access to records much more efficiently then PROMIS ever dreamed possible. However, only very few EHRs are capable of coming up with differentials, and care plans consist mostly of order sets that you can create yourself (if you wish). As to efficiency of data entry and pertinent information retrieval, we are only slightly better off than the PROMIS pioneer users were. You would expect that every EHR vendor, big and small, would be feverishly working on exactly these problems, trying to bring more value to their customers and differentiate themselves in a crowded market. Well, they were, until very recently.

As Meaningful Use is pushing, shoving, enticing and coercing everybody, by any means necessary, to abandon paper medical records and adopt EHRs, it is also redefining the nature and construct of those records and it is imposing a new set of priorities on all EHR builders. Meaningful Use is about collecting certain data and moving all data out of the originating system to all sorts of other systems, including patients, care providers, governments and other facilities, and more than anything else, Meaningful Use is about measuring clinical quality or lack thereof. There are 113 clinical quality measures proposed for Meaningful Use Stage 2 and there are 65 measures in the Accountable Care Organization (ACO) proposal, which Meaningful Use is also endeavoring to support. Although users are only required to report on a handful of measures for now, those who build decent EHRs must write code for all measures, and this is not a simple thing, since a single measure can require complex computations over many data elements which may or may not even exist in the software. Add to this the remaining Meaningful Use measures and you have a big problem, amplified by orders of magnitude due to the very short timelines between publications of new mandatory requirements. The result is that there are no development cycles left for such things as enhancing user experience, or adding features that customers routinely ask for. Granted, Meaningful Use is considering taking on usability of EHRs as well, but at least initially, this will be through the narrow lens of patient safety, and not so much related to direct value to the actual paying customer.

Are we then doomed to repeat the PROMIS disappointment on a grander scale because the value to the customer is not readily recognizable? Not quite. The differences between our effort to computerize medical records and those led by Dr. Weed forty years ago are many, and none is larger than the fact that today’s copiously funded campaign for EHR adoption is firmly anchored in a much larger effort to change the health care delivery system as a whole (for better or worse). While Dr. Weed was experimenting in one remote hospital, today we are moving full steam ahead on a national level in thousands of hospitals with hundreds of thousands of physicians in both hospital and ambulatory practice, and the point of no return (to paper) has been passed a long time ago. We do however run the risk of making the entire process unnecessarily painful, slow, expensive and fraught with unintended consequences, if we continue to prioritize the political needs of the project itself above and beyond the needs of the customer.

Meaningful Use Stage 2 – Horses, Camels & Signals

On June 8, the HIT Policy Committee at ONC has approved the Workgroup recommendations for Meaningful Use Stage 2. Before diving into the details, it is worth noting that the time crunch for moving from Stage 1 to Stage 2, for those seeking incentives in 2011, was proposed to be resolved by postponing Stage 2 for these early adopters for one year. As I noted before, if you are able to attest and obtain incentives in 2011, go ahead and do that. You will be rewarded by having the opportunity to stay at Stage 1 for 3 consecutive years. The final Stage 2 ruling is not expected to occur until June 2012 and judging by previous experience with Stage 1, the recommendations approved today will be significantly relaxed by the CMS process of proposed rulemaking and public comments. So although analyzing (rejoicing or bemoaning) the various measures on this long list is a bit premature, it may be helpful to look at the general principles embedded in this new stage of Meaningful Use.

Horses

Many of the Meaningful Use more pedestrian measures have remained unchanged, have increased in intensity, or have been moved from menu to core (more on this later). These measures include such items as recording patient demographics, maintaining medications, allergies and problem lists, recording of vitals, running reports, electronic prescribing, incorporating structured lab results, medications reconciliation, using formularies, enabling clinical decision support, reporting to state and federal agencies and ensuring privacy and security of medical records.

Other measures were slightly expanded in scope. CPOE, for example, was restricted to medications in Stage 1. Stage 2 is adding laboratory orders and capability for radiology ordering. While Stage 1 required that physicians send clinical reminder notices to young children and the elderly, the current proposal is to send those reminders to at least 10% of all patients, and patient education materials which were required “if appropriate”, are also extended to all patients in Stage 2. If you were not a hypochondriac before, you will be encouraged to become one in the near future. The requirement to document the existence of advance directives, which was limited to hospitals, is now also applied to physicians of all types. To even the burden, electronic prescribing, a strictly ambulatory measure, will now be required for 25% of hospital discharges.

And then there are several benign brand new measures:

• Both office visits and hospital days are required to have electronic clinical notes (30%). The measure is not very prescriptive on what constitutes a note other than forbidding scanned documents and requiring that notes should be searchable.  I can’t wait to see the certification test for “searchable”. It seems the committee is not aware that with very few and limited exceptions, EHRs are not very much like Google. This new measure ought to single handedly disqualify 99% of currently certified EHRs. The searchable part will probably be dropped during rule making.
• For hospitals, use of an electronic Medication Administration Record (eMAR) will be required in at least one department.
• Physician practices will need to record patient preferences for methods of communications, but hospitals strangely don’t need to do the same.
• There will be new clinical quality measures added to the current list to choose from, but this item alone warrants its own separate dissertation.

Camels

As one of the committee members astutely remarked, along with the horses a few camels are also being created by this proposal. Hopefully, most of these creatures will be reshaped and/or eliminated in the final rule, but right now here are the problematic recommendations:

• No menu items – Stage 1 allowed hospitals and clinicians some freedom in choosing which measures best apply to their situation. While 15 measures were mandatory (core), physicians and hospitals were free to select 5 additional measures from a menu of 10 choices. Meaningful Use Stage 2 is an all or nothing proposition.
• Hospital labs should send structured electronic clinical lab results to outpatient providers for at least 40% of electronic orders received – This particular triple humped camel elicited much discussion in the committee and exclusions may be provided for small hospitals. Considering that the overwhelming majority of hospitals, small and large, are not currently capable of receiving electronic orders, a fact that seemed to have escaped the committee, this measure amounts to pretty much nothing, since 40% of zero is still zero. It remains to be seen how many of the few hospital labs that can currently receive electronic lab orders will turn that capability off just to escape this particular requirement. Bi-directional lab interfaces are not without cost to build and maintain.
• Measures to be fulfilled by patients – There are two types of measures that hold providers accountable for patients viewing medical records online (10%) and for patients sending electronic communications to physicians (25 individuals). It is not clear who the messages should be sent to, but Meaningful Use is applicable to clinicians individually. I guess, practices and hospitals can make medical records available online and advertise the ability to communicate electronically, and hope that enough patients take advantage of that. Since we are dealing with all or nothing Meaningful Use compliance, it is more likely that patients will discover one more step in the check-in process – logging into the portal. The other issue here is that while certifying for Stage 1 Meaningful Use, many small vendors utilized third party PHR products (usually Microsoft HealthVault) to make medical records available to patients automatically. These vendors have no patient portals and no way to verify that patients actually viewed their medical records, without asking the patient to be kind enough and send in a copy of their PHR utilization reports.
• For care transitions, summary of care and care plan are sent electronically to receiving facility or physician, and care team members’ list is available for electronic exchange – This was probably the most debated set of measures and the results as they appear in the proposal are difficult on many levels. First and foremost, the care plan in Stage 2 is envisioned to be just free text attached to the standardized summary of care record. Most advanced EHRs have separate sections, some structured, where care plans are directly documented and/or automatically assembled based on orders. It is not clear how that free text is to be created to satisfy the measure, other than requiring physicians to document the plan a second time. It is also not clear how you hold one party responsible for sending things electronically while it has no control on the abilities of the receiving entities (look for major exclusions here). And it is completely unclear what exactly should be done with that free text list of team members, once it is available, and who should be on it (Other specialists? Hospitalists? Community resources?)
• The last two new items are just suggestions for CMS to evaluate, and both deal with expanding ambulatory reporting requirements to include syndromic surveillance and cancer reporting. Not sure if there’s anybody out there willing and able to accept such data.

Signals

As expected Meaningful Use Stage 2 is significantly upping the ante for 2013 (or 2014 now), but more importantly, the committee’s recommendations are also “signaling” to the more distant future of Stage 3. Possibly the most frequently used term in workgroup and committee meetings, “signal’ (used both as a noun and a verb) refers to providing hints to users and software vendors, indicative of intended future requirements of Meaningful Use – one if by land, two if by sea. So here are the brightest lanterns shining towards Stage 3:

• Have nationally endorsed lists of drug-drug-interactions (DDI) and ability to record reason for overriding alert – Your DDI alerts, the ones that you were able to adjust and configure to your liking, will be coming from a federal designated source. Hopefully they will come in the form of friendly advice. Either way, they will want to know why you are overriding things.
• Second hand smoking status will be added to just plain smoking status, and more refined race and ethnicity data will need to be captured.
• In Stage 3, EHRs will need to be able to store and retrieve those advance directives, not just indicate that they do or do not exist, which is pretty useless in and of itself.
• Family History recording will become a requirement as soon as they devise a proper standard for it. Considering that most EHRs already have structured templates for documenting all histories, and most of them are pretty much identical, it would be interesting to see what the new standard will look like and how much rework and data migration will be necessary.
• That care team field mentioned above will no longer be just free text. National Provider Identifiers (NPI) will be required. It seems that only licensed clinicians can be on a care team.
• Patient-generated data will be submitted to public health agencies - I am not going to even venture a wild guess regarding this one.
• Compliance with the Nationwide Health Information Network (NWHIN) governance policies should be included in Stage 3 certification criteria - Here is where the future is beginning to look awfully hazy to me.

If the proposal to extend Meaningful Use Stage 1 through 2013 is accepted by ONC and CMS, and it should be, Stage 3 will most likely be pushed out by one year as well, so these various signals are directed to the year 2016 through heavy fog and precipitation. It is too soon to alarm the country. The most immediate order of business is to smooth those camel backs, and we have an entire year to do just that.

Coordinating Care Coordination

Care coordination is one of the four pillars of Meaningful Use, one of the six NCQA Patient Centered Medical Home (PCMH) standards and one of the main goals of Accountable Care Organizations (ACO). Care coordination, particularly for patients with multiple chronic conditions, is expected to reduce unnecessary repetition of laboratory testing or imaging and the number of avoidable admissions. Other than reducing overall costs, care coordination is also supposed to improve quality of care. According to experts like Joe Flower, “Lack of care coordination is at the core of the mess healthcare is in”, and nobody in their right mind would argue that it is best that medical care remains disorganized and uncoordinated, if it is indeed so. It seems that our fee-for-service, fragmented and fractured (lots of f-words here) health care system is not conducive to care coordination. When patients float around in a sea of hospitals, physicians, nursing homes and other facilities, each care provider gets paid, and is responsible for the piecework performed at their independent entity and nobody is minding the handoff of patients to the next provider of care, and nobody is assembling a comprehensive picture of the entire care process, let alone orchestrating, or coordinating, the progression of patients between stages of care and the overall needs of patients in transit. What would it take then, to see that the bits and pieces of health care we now have, become a safe and affordable continuum of care?

CMS is taking the lead, as it should, in an all-out effort to encourage health care coordination through various carrot-stick initiatives, aligned to ultimately base payment for medical care on value to the patient, as measured on a population level, instead of fee-for-service and no accountability for outcomes. These initiatives fall into three general categories:

1. Health Information Technology to assist with documentation, information exchange and measurements as required in any coordination effort.
2. Incentives and penalties for providers based on measures thought to be influenced by care coordination (e.g. preventable hospitalizations, readmission rates, etc.)
3. Financial and structural encouragement for vertical integration of the delivery system (e.g. ACOs, consolidation, employed physicians, etc.)

Of all three categories, only Health Information Technology (HIT) is foundational.  HIT is supposed to provide a toolbox for simplifying and even automating many of the tasks associated with coordination of care. The other two categories are based on series of assumptions, hope, belief and lots of other magical thinking. A brief scan of Meaningful Use regulations, which is quickly becoming prerequisite to both PCMH and ACO, reveals the following proposed care coordination enhancing features:

• Health Information Exchange (HIE) – To paraphrase the quality measurement mantra, you cannot coordinate that which you don’t know. Most care coordination efforts today are based on faxes, phone calls and using the patient as courier for paper based artifacts. If there is one thing that computers excel at, it must be timely exchange of information. Aggregating and placing complete health information at the fingertips of all clinicians, in real time and with minimal loss of fidelity, would in and of itself eliminate most effects of geographical and organizational diversity and fluidity of care providers for any given patient. Most, if not all, remaining features are just elaborations on the information that needs to be exchanged, the actions to be taken following the exchange and the tracking of both the actual exchange and the activities surrounding such exchange. 
• Planning Care – Care plans are not a new idea, but now they will have to be composed with patient participation, and shared between physicians, hospitals and other care givers. The vision is to eventually have one collaborative plan of care accessible to all involved.
• Managing Transitions of Care – Here you find the multitude of documents to be shared when care is transferred between facilities and/or physicians. There are care summaries, discharge notes and instructions, medication lists that need to be reconciled, and the PCMH standard adds careful tracking of referrals, appointments, test results and consultation notes.
• Measuring Results – Meaningful Use lists 48 clinical quality measures, and more are being developed, ranging from weight measurement and dietary counseling to inpatient medication administration. At this point, this is mostly about measuring care process metrics.

What we have here is nothing more than classic Project Management: Planning, Collaboration, Change Management and Measuring. The project is health and the project owner is the patient. There are millions of such small projects executing every day around the country. In the current system, many are executing with no project management. Sometimes the owner assumes the role of project manager, sometimes a conscientious primary care physician takes on that role, but most often we all step in and out of a management role as the project heats up during events such as birth, acute disease or trauma, chronic disease diagnosis and terminal illness.  Most of us, including physicians, have no resources, no training and no decent tools to manage our health projects. In the business world, professional project management is part of every (successful) project, with purpose built tools and adequate budget allocations for this coordinating function.

Perhaps this realization is the main driver behind the expert advocated, and government endorsed push to consolidate health care into large business entities. The viewing resolution from Washington, and from equally removed academic departments, renders all our pixel-size individual health projects indistinguishable from each other in the large picture of population health. This is one case where the forest is obscuring the trees. So with the best of intentions, the government is proposing to create a handful of Project Management Offices (PMO), which is what ACOs really are, and make them fiscally accountable for operational profit and loss (P&L) at a population level. Instead of dealing with hundreds of thousands of small contractors, the government will be stepping into its familiar role of contracting with large corporations as the prime contractors for goods and services. These prime contractors, similar to their counterparts in the defense industry, will be at liberty to subcontract with smaller entities or employ their own resources, and together they will completely dominate all aspects of the market.

This massive reengineering of the health care delivery system is deemed necessary in order to begin eliminating the excesses and fragmentation brought on by the centuries old fee-for-service model of medicine. But if we learned one lesson from the fee-for-service model, we certainly learned that if we pay by the yard, we get more yards. So common sense begs the following question: if we want more care coordination, why not pay for care coordination (by the yard)? Unlike quality of care and outcomes, care coordination processes are easy to define, easy to measure and widely understood by all stakeholders. If CMS could define a set of CPTs for Evaluation & Management which entail counting all body parts being examined and accounting for all diseased relatives, couldn’t it define a set of Coordination CPTs to track care planning, exchange of care summaries, referrals, results, instructions and whatever else is deemed to contribute to care coordination?  Computers, HIT and the Internet are greatly enabling these activities, both inside and across organizations of all sizes, and are automating their documentation in the medical record. If physicians and hospitals were allowed to bill these Coordination CPTs at various levels for each encounter, and they were paid at attractive rates, we would see a flurry of activities leading to HIT adoption, health information exchange, collaboration and ultimately coordination of care.

Paying for care coordination on a fee-for-service basis will allow a unified definition of services and individual customization per patient. Some patients will need more, others will need less, and different people will need different coordination services at various times. Unlike a capitated fixed fee per patient per month, there will be no temptation to skimp on services and it is really hard to argue that too much coordination is even possible. Indirectly paying for a finished product, such as paying for outcomes, is very difficult in health care since the product is only finished when we are dead, and retrospective measurement of expenditures for dead people is nothing more than crying over spilled milk. If we maintain the granular fee-for-service system of levers, we can recoup coordination expenses by carefully reducing payments here and there for services we want less of.
So instead of punishing hospitals for failing to coordinate care, instead of penalizing doctors for lack of technology, instead of incenting everybody to do the right thing in roundabout ways, and instead of faith-based reengineering of the entire system from the top down, why not try to achieve our goals the American way, by paying a fair fee for an honest service?

The Cost Cutting EHR

Healthcare Information Technology (HIT) and Electronic Health Records (EHR) are at the heart of health care transformation. Everything we want to change and improve upon, hinges on the availability of EHRs in every hospital and every physician practice. We all know that EHRs can improve quality of care by providing evidence-based, patient-centered clinical decision support at the point of care, while measuring outcomes and customer satisfaction, so we can monitor and reward providers for their efforts. But this is not nearly enough. After all, our current health care crisis is not due to hundreds of thousands of citizens succumbing en masse to shoddy medical practices as much as it is due to having to squander 17% of GDP on pampering Americans with unnecessary, excessive and way too technologically advanced diagnostics and therapies. We must cut health care costs or perish. There could be an EHR for that. The following is a blueprint for transforming any EHR into a cost-cutting machine guaranteed to chop health care costs in half in less than one year of use.

Cost Awareness - There’s been much discussion lately revolving around small studies showing that when physicians are made aware of costs, they order fewer tests and save the system money, and it was suggested that EHRs can help place costs of everything in front of ordering providers. Absolutely. There is a tiny problem with obtaining true costs, as opposed to arbitrary prices, but in this era of Data Liberacion, surely we can summon the liberation of all insurance negotiated fee schedules. The innovative computer geeks can take it from there, and if we are missing some numbers here and there, we can make them up just as well as hospitals do. Armed with these data, the CPOE module will display the cost for every test about to be ordered, in a very patient-centered way, since we know what insurance the patient has. This in itself should also reduce disparities since Medicaid pays so much less for everything that we can easily order twice as many tests for Medicaid patients, for the same cost to society. Just so patients don’t feel disempowered, patient portals should clearly display tests and procedures costs as well. We could show the costs to their insurer, but a more deterring shock value would come from displaying the hospital list price, so patients can be better prepared in case the insurer decides to deny payments.

Subliminal Messaging – Well, yes this is illegal for advertising, but it should be acceptable for the public good. For providers, we should have two types of subliminal messaging in the EHR. Prospective messaging would flash inducements to order generic drugs for example. A more sophisticated and patient-centered strategy would be to tailor the message to the individual patient. So if, say, the EHR knows that the patient is there to discuss his PSA test results, and the EHR knows what the results are, it could flash “wait and see” all through the visit. Careful programming is required here to ensure that messaging occurs only on provider screens. Retrospective messaging could be used to create feelings of guilt and regret if providers order an MRI. It is likely that they would want to avoid these feelings in the future. We could integrate subliminal messaging into patient portals to help reduce utilization. For example, in the scheduling module, we could flash the word “NP” for consumers attempting to make an appointment, so they are guided to less extravagantly priced resources. Although this particular feature must be written from scratch, the potential for code reuse is obviously enormous. I’m sure pharmaceutical and device companies can come up with great ideas as well, but please remember that for marketing purposes, this is illegal, and no, this is not an infringement on commercial free speech.

Spending Counter – In the olden days when EHRs were mainly good for billing, some used to have funny little counters that showed physicians (there were no providers in those days) how much they made so far today based on selected E&M and CPT codes. Those widgets were not very accurate, and not widely used. Well, here’s a chance to reuse that old code or write new one if we must. As providers go through their daily work, the counters will add up how much health care money each particular provider has spent, in real time, and display the cumulative amount on every EHR screen (much like those page visit counters on the web).  As we gain more experience with value based benchmarking, the spending counters can become interactive. Each day spending limits could be preset per provider, adjusted to reflect schedule complexity, and the counter will run down all through the day as patients are seen and orders are placed. As the counter approaches zero, we could implement popup alerts to notify providers that the end is near. When the spending counter hits rock-bottom, the CPOE module is disabled and no further orders can be placed without administrative override. We can reduce spending limits by a few dollars every week and like Milo of Croton, providers won’t even notice the gradual cost efficiency achieved over time. To foster healthy competition, we could display other providers’ spending status too. The larger the group practice, the more competition we can foster.

Patient Centered Spending Counter – Upscale EHR vendors who are marketing their products to Accountable Care Organizations (ACO) may want to personalize the above counters for each patient. These widgets should display on the summary page for every chart and on each screen where the patient is in context and be represented by an hourglass graphic image. Since the ACO will be receiving claims data from other providers, we could easily calculate how much was spend on each patient during the current fiscal year and compare to what the ACO projects that should be spent to maximize shared savings. To assist providers at the point of care, an info button should be added that will provide clinical decision support when the hourglass gets low on sand. For example if the patient already had six office visits this year, the software may suggest sticking to e-visits and secure messaging for the rest of the year. It is very important to display this counter in patient portals as soon as the consumers log in, so they can judiciously manage their personal flow of sand. The ACO may wish to offer small, Sand Savings rewards to consumers who end the fiscal year with a surplus of sand in their hourglass.

Break the Plastic – Many EHRs, particularly those designed for inpatient care, have a “break the glass” feature which, in an emergency, allows physicians to access medical records of people who are not their patients. Physicians are given explicit warning that such access will be logged and audited and often these events are indeed audited by administration. The EHR code used to implement this functionality can be easily modified to support adherence to evidence based medicine and assist providers in keeping unreasonable consumer demands at bay. For example, if a provider caves in and attempts to prescribe an antibiotic for a documented diagnosis of common cold, the EHR will pop up a dialog screen with a red stop sign icon saying that this action cannot be completed. The provider may then show this screen to the consumer and hopefully he/she will just go away. If the consumer insists and the provider is talked into changing the diagnosis and trying to prescribe the antibiotic again, the EHR will pop up a different alert stating that the documented positives do not match the new diagnosis, but if the provider wishes to proceed and “break the plastic”, the event will be logged and audited by the committee to discover the reason for changing a diagnosis after trying to prescribe. Hopefully the consumer will take pity on the provider by now and go spend his own money on a Theraflu generic at Walgreens.

Consumer Digital Signature – Most EHRs today have nifty little checkboxes that allow physicians to acknowledge that they provided counseling to patients on a variety of issues. Since we know that a lot of money can be saved by providing consumers with counseling on smoking cessation and weight management, for example, we need to be certain that such counseling was indeed provided in earnest. Who better than the consumer to attest that sufficient counseling took place? All we need to do here is implement existing code for digital signature, usually written for the provider e-prescribing module, and add it to the progress note page. If satisfied, consumers will enter their special credentials, a simple PIN should suffice, at the end of the encounter. Other than saving money by improving lifestyle behaviors, the EHR can keep count of counseling sessions and automatically deliver a small punishment to consumers who show no positive changes in behavior. For example, a smoker who digitally signs 3 cessation counseling sessions, but is still documented as a smoker on his fourth visit, may see his Sand Savings reward disappear. Small rewards and punishments have been shown to consistently improve wellness and save money.

As outlandish as these features may seem, they really are quite easy to implement in a robust EHR. The only complex development consists of the various real time interfaces with insurers to bring claim data into the EHR, which is really nothing more than reversing the current interfaces that send claim data out to payers. As health information exchange matures in the next couple of years, and more and more data is liberated, many different cost cutting, personalized features could be added. Unlike the first generation of EHRs, widespread adoption should not be a major problem since most providers will be employees of large systems and accustomed to following policies and procedures. Judging by the growing spirit of innovation in Health IT, it may also be easy to find young entrepreneurial companies to quickly build this type of widgets and integrate them into existing EHRs for a fraction of the cost of proprietary development. These are exciting times.

NPfIT Blazing the Trail

The National Audit Office (NAO) in the UK has recently published a report evaluating the status of “The National Programme for IT in the NHS” (NPfIT). The program is a very ambitious top down initiative to deploy Health Information Technology across all NHS facilities in an attempt to provide an electronic care record for every patient in the UK. The blunt conclusion of the report states that “The original vision for the National Programme for IT in the NHS will not be realized” and “This is yet another example of a department fundamentally underestimating the scale and complexity of a major IT-enabled change programme”. Is this gloom ridden report in any way pertinent to our own quest for an EHR for every patient by 2014? Of course not. We don’t have a Socialist system where the government can decide on a particular EHR product, buy it, contract billions of dollars in services, and force all hospitals and doctors to install it and use it in their facilities on a government dictated schedule.

Instead, the United States Government is building a National EHR, and I find the business model fascinating. No, the Feds did not hire a team of software developers, did not set up a business entity and didn’t even hire a defense contractor to do all these things. Instead, they legislate and engage in a flurry of rule makings which are then applied in quick succession, like giant levers, to the delivery side of our health care system. This is nothing short of brilliant.

While NPfIT engaged in the purchase of two EHR products, defined future releases and paid for implementing those in medical facilities, the US government is skipping the capital investment in EHR products, replacing it with a complex incentives and penalties scheme intended to ensure that all health care entities invest their own money in implementing technology which is designed to government specifications. The initial lever is commonly known as Meaningful Use (MU). There is a secondary and smaller lever embedded in the definition of Patient Centered Medical Homes (PCMH), and the final gigantic lever will be pulled along with the advent of Accountable Care Organizations (ACO). The holy grail of both NPfIT and the US government program is, of course, interoperability which will allow the creation of that elusive EHR for every patient and the global reporting of health care indicators to government agencies. At first glance, it seems that the uniformity and mandatory nature of NPfIT would better serve this goal. But NPfIT is failing miserably, so perhaps our way is the better way. If we can achieve universal health care by mandating that millions of people purchase government defined insurance policies from private corporations, subject to minor penalties, why can’t we achieve universal health records by mandating that a few thousand health care providers buy government designed EHRs from private vendors, subject to equally minor penalties?

We probably can, but only if government is thoughtful enough to allow meaningful customer choices and humble enough to admit that customers are not stupid (excuse the harshness). In the case of EHRs, the customer is the clinician. Yes, hospitals, integrated systems and probably even health plans, may be buying these products, but as many have discovered the hard way, if physicians don’t like the technology, nothing will be accomplished. Industry publications are overflowing with indictments against EHR products being designed for administrative purposes instead of patient care and designed by engineers with no regard to, and no input from, practicing clinicians. That’s the past. The present is witnessing the top down design of all EHRs by government committees of experts in health policy, academic research, business, insurance, technology, and a myriad other special interests, with the expressed goal of advancing current health reform policy.

The basic Meaningful Use lever is now in its second stage of design and according to the government, it is an “escalator to where the country needs to be from a health reform point of view”. As such, it is imposing an ever expanding list of items that physicians must record when seeing patients. You must record patient demographics, of course, but you must be sure to capture a refined definition of race and ethnicity. You already knew to ask each patient if he/she smokes, but now you must phrase the answer in one of several sanctioned formats, and you should also ask about second hand smoking, and even if you are an optometrist, you should ask about these things. There must be someone, somewhere, extremely interested in the type of contact lenses purchased by Native Hawaiian and Other Pacific Islander populations who were exposed to second-hand cigarette smoke (cigars don’t count). You are certainly recording vital signs now, and if you are a pediatrician, you probably have those lovely growth charts to go with it. If your young patient is hospitalized for, say, an appendectomy, you will be pleased to know that the hospital too must maintain growth charts, so we don’t miss even a few days of growth. You will also have to document your response to various drug interaction alerts in a soon to be defined standard format and record family history in another pending standard format. Following a national storm in a teacup, CMS elected not to reimburse physicians for the advance directives “discussion”. Too bad, because you will have to document that discussion now, along with the equally unpaid for, secure messaging with your patients. And the list goes on.

In 1995 and then again in 1997 CMS saw fit to define exactly what physicians must document during a visit in order to get paid. Those guidelines were the foundation for most EHR designs until very recently, and those guidelines are the reason for EHRs being perceived as billing oriented instead of patient care and clinician oriented. Compared to Meaningful Use, the CMS E&M guidelines are child play in their complexity and prescriptiveness. Since every EHR vendor today is busy implementing Meaningful Use designs with the same fervor that they implemented E&M guidelines in the past, it looks like we are going to end up with pretty much the same result – technology that will allow customers to collect money from CMS. One could argue that this is a very pessimistic view. After all, unlike the E&M guidelines, Meaningful Use is supposed to be about improving quality of care, patient centeredness, interoperability and better outcomes for patients. What’s wrong with supporting policy if the policy is good and sound?

Nothing really, except that policy-driven software design, enforced by certification, is minimizing the most important factor in widespread adoption of any product – the voice of the customer. What little influence customers were gaining on EHR software design is now drowned by the relentless grinding sound of vendors trying to keep up with Meaningful Use directives and certification criteria. Substituting committees of experts for actual live customers and their often unexpected wishes has never been proven a successful product strategy, and unlike the NPfIT in the UK, our government is not giving out these soon to become cookie cutter EHRs for free, and is not (yet) in a position to force physicians to use them. Increased market penetration and successful adoption of technology usually hinges on the product’s ability to solve a problem for which the customer is willing to pay. I may be wrong, but I doubt that the majority of physicians in this country are willing to pay for health reform.

The Last Best Hope

According to the recently published CMS Accountable Care Organization (ACO) rules, an ACO needs to care for at least 5000 Medicare beneficiaries. Theoretically, two primary care physicians and a nurse, practicing in a garage, or cottage, in Boonville Missouri (yes, there is such a place), seeing nothing but Medicare folks, could become an ACO. Of course, they would have to set up a business entity with a board of directors, hire a couple of lawyers, several accountants and contract with a hospital or two and a score of specialists, and be ready to accept financial risk for their patients in a couple of years; all this on top of seeing twenty to thirty elderly and complex patients every single day. Nope. Not going to happen.

ACOs are for the big boys, hospitals and/or extra-large multi-specialty groups, to set up, manage and perhaps eventually benefit from. Big systems, as we all know, enjoy economies of scale, are better able to manage and coordinate care, and are therefore uniquely equipped to solve our health care crisis by providing better care at lower costs, and ACOs are just the vehicle by which these systems will be rewarded for all that good work. If you care for people in a small primary care practice, you could bite the bullet and sell out to a large system, or you could retire if you are one of those last standing dinosaurs, or you could become a concierge practice, or you could sit still and watch your practice dwindle and die, or you could buy an EHR, which is the last best hope to keep primary care independent.

Science, the type of science that employs mathematical hypotheses, theorems, proofs and equations, is timidly asserting that the emperor is in need of some serious clothing. A 2009 paper published in a non-medical, non-health care venue, “examines the staffing, division of labor, and resulting profitability of primary care physician practices”. The authors who are researchers from the University of Rochester and Vanderbilt University conclude that “many physicians are gaining little financial benefit from delegating work to support staff. This suggests that small practices with few staff may be viable alternatives to traditional practice designs.” Although I did not check the math, which is extensive, I would have expected that such controversial conclusion would make headline news in health care policy forums for at least two or three days. It did not.

From John Hopkins and the MGMA, we have a 2010 manuscript titled “Size Matters: The Diversity of Physician Practice Production Functions”, also complete with mathematical analysis, which reaches several interesting conclusions. First, it seems that “multispecialty practices gain by size through the creation of an internal referral network among their physicians, and through the capture of ancillary services and control over equipment and facilities”, which identifies one of the reasons why health care costs are steadily increasing. On the other hand, for primary care practices who “have few opportunities to generate production (and revenue) beyond direct patient care and cognitive services”, it seems that “organizational complexities of larger size (and the attendant perception of loss of control by each physician as the practice grows) will rapidly overcome any limited production advantages”. The authors offer two hypotheses for the observation that “[t]he median size of actual physician practices is considerably smaller than expected by estimated production efficiencies”: one is that in addition to maximizing income, physicians may have “non-profit-related goals such as professional autonomy and service to patients”, and the second is that “practice size may not be rewarded in the market”, therefore “health care reform proposals that expect that physician practices must become larger and more integrated will need to identify or create incentives for practices to expand (through internal growth or merger)”. It seems that ACOs have adopted the second hypothesis and rewards are forthcoming.

As early as 2003, researchers in the UK have warned the NHS that quality of chronic disease management in primary care (ischemic heart disease, in this case) is not necessarily associated with practice size. “Although recent developments in the NHS have cast doubt on the future of smaller practices, both patients and the doctors seem happy with smaller practices. Smaller practices are seen as more accessible and achieve higher levels of patient satisfaction. The NHS should reconsider how it can improve the quality of care provided by general practices, without relying on the presumed benefits of consolidating them into larger units”. On the other hand, in the US, acute myocardial infarction seems to be significantly more dangerous to patients of solo practitioners, as reported by a 2007 study published in Health Affairs. The same study notes that “[patients] of solo physicians appear to be less healthy in many of the measures. They also were more likely to have physicians that were female (except those of the largest practices), over age fifty-five, in internal medicine, and with non-U.S. medical training”. I for one, have no idea how to interpret this statement or its implications on the study results. To be sure, other studies, such as “The Relationship between Practice Size and Quality of Care in Medicaid” from the Center for Health Care Strategies, have found that small practice size may have ill effects on some quality measures, less on others and strangely improve access to care for some populations.

Small practices usually score very low on measures that are believed to be indicative of ability to provide better care, such as various preventive care screenings, consistent patient reminders, disease management testing and last, but not least, availability of Health Information Technology (HIT) to facilitate all of the above. It may be that documentation is lacking and it may be that small practices just don’t measure very well. As Dr. Lawrence Casalino told amednews.com in 2007, “[t]here is no question about whether large practices that can invest in it and hire staff to make sure they score well are likely to have higher Pap smear rates than people in small practices. But when you get to things that are perhaps harder to measure, like diagnostic skill, then we don't really know anything about how group size might affect that".  By 2008, Dr. Casalino seems to have reached a different conclusion. A JAMA article he coauthored, and which sets forth the blueprint for the recent CMS ACO rules, states: “At the heart of the challenge is transforming a 19th-century craft-oriented delivery system to provide 21st-century biomedical science and technology. Most physicians still practice alone, in partnerships, or in small groups. Small practices generally have less capacity to implement electronic medical records, less frequently use teams to care for patients with chronic illness, and are less able to provide statistically reliable and valid data on quality and efficiency measures. A more solid foundation of physician organizations is needed to avoid having the system crumble under the increased weight of greater demand for care and technological advances.”  By 2010, in a Roundtable discussion, Dr. Casalino seemed again, less certain, “I don’t think that accountable care organizations will succeed if they don’t make life better for patients and also for physicians. They just won’t. I don’t think you can have a major delivery system reform in this country with physicians actively opposed to it. And I think we found that out in the ‘90s.” and he even acknowledged that small practices may have some merit after all, “So there could be these virtual networks. And the concept is, physicians who want to be in small practices and patients who like to go see physicians in small practices — and there are real distinct advantages, I believe, to that setting for both the patients and physicians — would have the option to remains so.”

Bottom line is that when people are being intellectually honest, they have to admit that practice size is just one of a multitude of factors influencing quality and cost of care, and probably not even a very important factor. However, there are three major roadblocks to small practices being perceived as a viable option for the 21st century: lack of health IT, ineffective collaboration with other entities and the inability to measure performance due to small panel size. The beauty here is that removal of the health IT roadblock will automatically remove the other two, because when using computers, collaboration does not require physical proximity and performing analytics on aggregated data is a trivial task. Since the legendary economies of scale supposedly available in large practices have never been calculated and shown to actually exist, and since the advances in Internet-based training and support tools are driving costs of HIT acquisition and deployment down, particularly for small practices who don’t need many of the enterprise bells and whistles in top-shelf EHRs, the 21st century medical practice is within the reach of any solo practitioner.

So if you are an independent primary care doc in small private practice, and would like to stay that way, the best thing you can do right now is to position your practice to take advantage of things to come, or at least ensure that you are not losing ground while you are waiting to see which way the wind blows, and this unequivocally translates into getting an EHR (a cheap one will do), getting connected to the world, exchanging whatever clinical information you can, getting those clinical decision support rules running and, most important, learning to score well on quality measures.

I know this advice may seem unpalatable to many and I know that EHR may seem just another insult to add to the improper reimbursement injury, but what worked well in the past is not likely to work as well in the future. An EHR may not be enough to preserve some semblance of independent primary care, but it is truly the last best hope, and hope is all it is.

(Over)Simplifying EHR Usability

Dr. P patted the middle aged patient on the back, helped him off the elevated exam table and guided him to the chair by the sink. He picked up the chart and using the exam table as his desk he flipped through the chart, pulling out several pieces of paper, spreading them to his right, while making small talk with his patient. He reached into his pocket and pulled out a battered silver recorder and without any warning started dictating: “Mr. H is a 60 year old mildly obese gentleman presenting with…..“. He had a pen now in his right hand, and as he was talking into his recorder, shuffling the various papers in front of him, he was also writing orders and prescriptions as fast as he was dictating. “….follow up in two weeks” was the last thing he said. He didn’t write that one down, but turned around, handed the patient a bunch of scripts, told him to stop by the front desk and make an appointment two weeks out and stop by the lab on the fourth floor to pick up a container for the urine test. Two minutes, tops, including the small talk. It was my turn now and I was sweating bullets because I knew exactly what he is about to say. “Can I do this in the EMR?”

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EHR usability has finally arrived to Washington as the guest of honor at the most recent ONC HIT Policy Committee hearing. ONC seems to be considering the regulation and certification of EHR usability. NIST has created a testing procedure and just like its Meaningful Use testing procedures, it is superficial and doesn’t really test anything of any consequence. Those who represented “providers” and patients argued for the need to improve usability and those who represented academia and grant funded research argued for more funded research. Predictably, usability experts, argued for hiring more usability experts. Large vendors eloquently stated their objections to government mandating what EHRs should look like and small vendors argued that the more mandates, the better, since this will automatically remove the built-in competitive advantage of those with larger budgets and larger usability departments. As is customary, EHRs were compared to ATM machines, cars, iPhones, Google and a variety of “other industries” that are all so much more advanced than health care when it comes to usability.

When usability, or lack thereof, is discussed, most actual users of EHRs (oddly, there was only one of those at the ONC hearing) think about too many clicks, too many screen changes, convoluted workflows, stilted terminology, finding needles in haystacks, slow and freezing software, crashed servers, disappearing information, mind numbing alerts and lack of functionality. But wait, there is more… There should be out-of-the-box interoperability, ability to customize everything, thousands of templates, no bugs, no need for training, no need to document all that crazy billing stuff, and it wouldn’t hurt if it looked pretty and colorful (as opposed to “dull”), and it should work on the iPhone, iPad, Blackberry, Android, Mac and Windows 98 too.

There are two questions facing all involved: How to measure usability, and who should define and measure usability. The ONC committee is presumably exploring whether government should be the answer to both questions. Before you cheerfully agree that government should indeed regulate EHRs through an FDA approval process, let’s take a minute and explore what it is that we want government to regulate. No doubt, we want government to ensure safety of patients. Since EHRs are part of the clinical process, the FDA has, in my opinion, a clear and definitive role in making sure that EHRs do not endanger people’s lives. Usability, however, is a much larger aspect of a product than safety. To use the completely inappropriate analogy to automobiles (more on that later), it is pretty obvious that government should mandate that cars come with airbags and seatbelts, but it is less clear that government should mandate that all vehicles come with heated seats or automatic transmission, even if manual transmission and freezing bottoms may be tied to some types of accidents, for particular types of users, in particular circumstances, at particular times of day. And here is a trickier question: should the government fund and engage in the design of a preferred seatbelt, and then require that all automobile manufacturers use the exact same design?

Back to the more general question of usability and how it should be measured. ONC is funding projects and the government is paying for contracted work to provide an answer to this question. The initial outcomes as presented at this hearing consist of a rather strange standard form for assessing effectiveness (success/failure), efficiency (time to completion) and satisfaction (subjective) for several use cases based on narrow Meaningful Use criteria as defined by NIST testing procedures for certifying EHRs for Meaningful Use incentives. For example, an evaluator would be asked to prescribe a statin for a patient, or record vital signs, or execute a similarly granular sub-step of real life clinical scenarios. I don’t think I need to belabor why this exceedingly simplistic approach provides no indication for evaluating usability of the EHR. However, as one participant stated during the hearing, it seems that it is better to measure something than nothing. If you are reading this and you are a physician, this way of measuring things out of context, just because we can, would be akin to measuring the percent of patients sitting in your waiting room at a random date and time with a blood pressure under 130/70, and deciding that you are a good doctor if they all do, or a bad one if they don’t, whether you are a pediatrician, a geriatrician, or if you practice in a posh suburb, or tending mainly to indigent and homeless folks, or if it just so happens that this is the time when you do sports physicals for the local boys’ lacrosse team.

To continue on this path to oversimplification, there is a much circulated drawing in the circles of EHR usability experts (created by a former colleague of mine, Eric Burke), depicting three screens: the first shows an Apple screen with one word on it - “touch”, the second shows Google’s famous home page with nothing but a Search button, and the third is a cluttered data entry screen supposedly belonging to an EHR. This drawing is supposed to impress upon us how horrific EHR designs are by comparison to “other industries” and other software products we use in our daily lives. I’m not totally sure what the Apple screen is supposed to symbolize since touching a blank screen does nothing for me (sorry, Eric). I do understand the Google search screen and I agree that if you only want to do one thing, you should only have one button. When you want to do many things, many business and enterprise type things, it would be more meaningful to compare an EHR screen to say, SAP, or Siebel, or Epicor, or Photoshop, or any serious CAD application. The results of such comparison may surprise some usability experts, who seem to have all the answers. EHRs are not leisure applications for consumers and EHRs are not gaming platforms. To use the automobile example one last time, EHR is to iPhone and Facebook what a Ford F-150 is to a Little Tykes Cozy Coupe.

In conclusion, I would like to leave you with a screenshot of a widely used EHR. It indeed defies almost every single usability expert generated opinion on what good design should look like. However, if you look very carefully at the top-left of the screen, you will see that this is a screenshot from VistA, the VA EHR, designed and built by clinicians for clinicians. I have not met a single doctor who used VistA and did not really, really like it.

Click picture to enlarge

So let me ask again, who do you think should decide what a good and usable EHR should look like, a Government usability expert or Dr. P?