On Health Care Technology

Arguments for a Universal Health Record – Part II

2012-01-28T13:00:00.000-06:00

All animals can exchange information when in proximity to each other. Humans advanced this useful exchange to occur when the interacting parties are far apart, which makes the human animal quite unique. First came human couriers carrying verbal information, followed by human couriers carrying written missives, then came technology. Technology in the form of transportation vehicles, and technology in the form of unmanned transport of sounds and symbolic characters, changed the world. Telephones and computers on the Internet rendered the travel time of information from any point on the globe to any other point to milliseconds or less, but did not change the age old paradigm of information physically moving from one place to another. Until now.

This is the age of social media. Those of us who remember licking envelopes and stamps are often tempted to dismiss social media as a superficial waste of time better suited to perpetually distracted kids than any serious endeavor. When you think about Facebook, Twitter, Google+, Farmville and such, it is hard to believe otherwise. Ignoring the actual activities currently occurring on social media platforms, and looking exclusively at the mode of communication, one is forced to acknowledge that a change in paradigm has occurred, and we are reverting to exchanging information when we are in close proximity to each other, only this time around proximity is virtual, not physical. Information ceased to travel virtually, and instead, we do.

When we “go to” Google+ and engage in a lengthy discussion regarding Universal Health Records, we are creating and consuming content which resides in one virtual location – Google’s network of servers. If you want to participate in such conversation, you have to “come to” Google+, just like you had to come to Town Hall in days gone by, if you wanted to debate matters of importance. Unlike exchanging information by horse, train, telegraph or email, this communication paradigm is once again social, but flexible enough to occur in real time or at a time of your own choosing.

Back to medical records. Today most medical records are stored in physical format (paper) at various physical locations (brick and mortar facilities). Health information exchange is occurring mostly through courier, whether manned (patient, snail mail) or unmanned (fax). Those who advocate for electronic medical records desire to change the format of the record from physical to virtual, leaving the storage of virtual records pretty much as it is today. Once the content is computerized, it can also be exchanged by computer couriers, such as email and Electronic Data Interchange (EDI). This is supposed to make medical records “liquid” and the data can then flow from one computer to the other in a network of rivers and rivulets spanning the entire nation. Since such a complex system of waterways can be useful only if 100% clean water is allowed to flow through, as opposed to a mixture of seawater, oils, spirits, and other beverages, much care must be exercised at every medical records repository to transform whatever is released out into the public system to clean water. As discussed in part one of this series, ensuring water purity and building canals, dams and other infrastructure is expensive, fraught with peril, and assuming such system can be built, it is also obsolete right out of the box.

What problem are we attempting to solve by computerizing medical records? The customary answer to this question is that medical care has become extremely complex, it requires scores of professionals working together and, to foster better outcomes, they should all have the most accurate pertinent information at their disposal. Now, if we could bring all these professionals into one room filled with books and journals, and sit them down around one table, we would be just fine with old fashioned verbal information exchange. Since this type of physical proximity is becoming less and less likely, we find ourselves in need of a solution to allow disparate teams to collaborate on one project. We can do this the old way, and arrange for virtual information to flow electronically between team members, or we can do this the social media way, and arrange for team members to meet in one virtual space and work in virtual proximity. But wait, there is more... In health care, our projects are longitudinal. Each episode of care builds on all previous ones and also informs all episodes to come. This in a nutshell is why the entire medical record must be an open and shared resource.

Given the realities of our health system of systems, I am being told that such selfless collaboration at the data level is very unlikely, and given the real and manufactured concerns with privacy and government oversight, having a universal comprehensive data store is politically impossible in health care. Nobody objected to the technical soundness of the proposed solution. Granted, health care is much more complex than Google+ or Google Docs, and we will need more data, more definition and a much bigger and more sophisticated transactional database structure. As much as I would like to, we cannot flip a switch and begin accumulating universal health records overnight. So how would we go about starting to move in this direction?

One very promising idea comes from Dr. David Kibbe and the Collaborative Health Consortium. The notion of a health care collaboration platform, or clinical groupware, could do for health care what Google+ and Facebook did for virtual social interaction, but it stops short of providing a longitudinal and open medical record. If you were an avid Facebook user and recently tried to switch to Google+, you probably already encountered the big tall wall surrounding that particular platform. While this may be a minor nuisance when it comes to social media, and fully understandable from a software, or platform, vendor business perspective, it is not so minor when it comes to medical records, as every doctor who tried to switch EMRs can tell you. Every business should have the right to erect walls around its platform, its innovation and its intellectual property. No business should have the right to monopolize patient data, even if it was created by services and tools of a proprietary platform. The data layer must be separated from the service platform layer, because the data layer belongs to individuals and, in aggregate, it is a public good.

Another suggestion was that initiating standardized information exchange may lead to the eventual creation of local and later regional data stores. Perhaps the various State HIE organizations would grow into such data repositories. Perhaps the ever expanding integrated health systems would accomplish something similar. Eventually, we may be able to connect all these repositories into a federated model of national health records. All this is possible of course, but this rudderless experiment strikes me as a major waste of time and resources. So here is a small suggestion. There are several billions of dollars appropriated for a VA/DoD joint EHR which is supposed to be open source. Presumably, such effort will yield a database schema sooner rather later. Let’s use that. Let’s define a minimum set of data, not much different than what is required to be exchanged for Meaningful Use, and begin populating a national database. It will take time before this becomes the authoritative version, but it will happen. Initially, we can mandate certified EHRs to use the national database to retrieve and update this modest dataset in real time. This should not be a very difficult task for EHR vendors. At the same time, we should allow new products to be developed against this new and open schema. What would be the cost of building a simple user interface to the Universal Health Record to display an accurate list of problems, meds, allergies, immunizations and lab results? Hint: very close to zero. What value would physicians, and patients, derive from the ability to access such definitive lists for any patient, any time, from any browser, on any device? You decide.

Health Information Exchange is an outdated paradigm. It is based on understanding the Internet to be an improved version of the Pony Express system. The Internet has evolved into something completely different and unless we evolve with it, we are doomed to be arming heavily for a war that has concluded and it will never be fought again.

Arguments for a Universal Health Record

2012-01-22T17:14:00.000-06:00

We passed the one thousand mark on products certified as EHR technologies for ambulatory care and the five hundred mark for inpatient care, and there is no relief in sight. In addition, there are multiple other software products that are routinely used in health care, such as standalone practice management and billing systems, claim processing software, pharmacy programs, lab, imaging and other diagnostics software, personal health records products, and more recently a veritable explosion in mobile applications ranging from monitoring your heart to evaluating your happiness. I don’t know of any other industry where so many disparate software packages are able to communicate and cooperate with each other seamlessly, and yet this is the goal of the gargantuan effort of those who develop interoperability standards in health care. If you’ve ever been involved in software systems integration, you probably know all too well that the weakest and most unstable link is always at the interface between products, even those built by the same vendor, regardless of the agreed upon standard. When it comes to seamless operations and cost effectiveness, nothing beats true database level integration.

For those who read this and have an irresistible kneejerk reaction tempting them to cite examples such as ATM networks, telephone networks, Google or email, please understand that this is an apples to unicorns comparison. Assuming that our ultimate goal is to have all health records for all people available at all geographic locations at all times, is weaving a web of rickety interfaces between thousands of products, really the best option? It is, if you sell existing, or enabling, technology for this arrangement, and it is not, if you intend to use, or pay for, the end solution.

The usual arguments against a Universal Health Record, and its scary database in the sky, are that we must build on existing infrastructure; that rip-and-replace is cost prohibitive; that a free market should provide as many choices as possible; and that privacy is best served by keeping data close to home, and certainly out of the hands of Big Government. Sounds pretty reasonable. What if we dig a bit below the surface though?

Medical Records

Assumption: At any given moment in time there can be only one correct version of a complete medical record for any one person
Fact: Currently, various parts of the medical record are stored at various locations, by various organizations, in various formats
Fact: Most organizations possess unique content, but also content overlapping with what others store, containing multiple discrepancies and various errors
Observation: Using partial medical records for provision of care could be desirable, inconsequential, dangerous or lethal, depending on which parts are missing
Observation: There is conceptually no reliable way to know whether parts of the medical record are missing at the point of care, let alone ascertain the criticality of missing parts

Health Information Exchange (HIE), as its name indicates, is intended to shuffle fragments of the medical record from one organization to another just in time to inform the provision of care. The government and various other organizations are diligently working on standardizing the contents, the format and the means by which medical records data is communicated. Since the thousands of software programs deployed in health care all store data in different formats, using different data dictionaries, different storage systems and different terminology, it is envisioned that each system will have some sort of transformer at its edge that will translate the inner workings of the system before sending information out, and execute the reverse procedure before letting outside information in. Once the standards are finalized, all technology vendors will be building (or buying) such “transformers” and everybody will be communicating seamlessly. Could it really be that simple?

Reconciliation

Unlike banking, where managing a checking account at your local bank does not require immediate information on your Cayman Islands holdings, medical care operates on a single record set of data elements. Since this record set is being altered at various care facilities, health information exchange must continuously reconcile the data elements. So for example, let’s say that you visit your primary care doctor complaining of chest pain and he diagnoses gastrointestinal disease and prescribes antacids, but you are still concerned and decide to see a cardiologist in the city, who diagnoses angina. Shortly after visiting the cardiologist office you get hit by a bus and end up in the local ER. Was your cardiologist aware that you have been complaining of chest pain for the last 20 years, angina was repeatedly ruled out in spite of your concerns that Aunt Mary also has angina, and antacids always worked for you? Is the ER aware that you just got diagnosed with angina and have a shiny NitroMist sample in the backseat of your car? Is your primary care doc going to be appraised of your adventures? In a world of perfect information exchange the answer is yes to all questions.

However, perfect information exchange in this case requires that your primary care physician pushed your medical records out to the cardiologist, including your fixation with angina and Big Macs, or that the cardiologist was able to locate your primary care records and pull the information in. It also requires that the ER was able to obtain your primary care records from back home, any other medical records from other providers and also the very recent cardiologist records and combine all those data points in one authoritative record set. This reconciliation process would occur every time you seek care and every time you, or other diagnostic facilities and eventually devices, update your records in any fashion. And these transactions will have to execute without a unique patient identifier just for you, and while processing and propagating privacy rules which may differ between various care providers and exchange intermediaries.

Now imagine millions of people with similar needs, and you have many millions of transactions flying around back and forth between thousands of software programs executing in hundreds of thousands of locations, from industrial strength data centers to the lonely Dell server under the printer in a doctor’s office. Yes, the contents will be standardized by those edge transformers, but every relay, every handshake, every acknowledgement and every translation back and forth to the native software program constitutes a point of possible failure, and every reconciliation of multiple messages from disparate sources is an error waiting to happen. In computer land errors don’t usually wait for too long before they happen, and this has nothing to do with lack of standards. Sending applications lose connectivity intermittently and go into a peculiar state of limbo. Receiving applications often get stuck on one bad message, creating huge processing queues on the other end. Messages mysteriously disappear only to be found in a log file or another patient’s chart. Every new release is always an adventure. This is how things are today, with only a fraction of the envisioned number of transactions in the brave new world of a seamlessly connected health care system.

The Power of One

The alternative to having a flimsy system with a multitude of moving parts is to have one unified database system, with one architecture and one schema definition. This does not necessarily mean one EHR. We could of course have a single EHR built on top of this database system, but for those concerned with innovation, free markets and with the problematic one size fits all approach, by all means, let’s build thousands of EHRs with user interfaces and functionality to fit every individual preference, all accessing the same exact database, containing the same exact records. This Universal Health Record will be, by definition, complete and correct at all times, since all health care applications will be built on top of this database, much like browsers are built on top of the World Wide Web. Switching EHRs should be as simple and straightforward as changing from Firefox to Chrome, not to mention how happy the folks advocating substitutable applications instead of walled gardens would be. Oh, and the sum total of investment in a homogeneous data infrastructure is dwarfed by the various other public and private initiatives, all ultimately funded by tax payers.

The 800 pounds gorilla in the room is of course privacy and to a much lesser extent security. A medical database system of this magnitude would have to be built and administered by the Federal Government. Patients would have to be uniquely identified in the system. Granted such Universal Health Record would accessorize well with a universal health care system, but let’s face it, if you are on Medicare or Medicaid, the government already has your medical records. Private payers have mega databases chockfull of medical records and so do EHR companies and pharmacies. Your data is being constantly de-identified, sold, re-identified and exploited for financial profit. Once the planned information exchange network kicks in, a host of State and private agencies will also begin building their own repositories of medical records. The privacy horse has left the barn, and the best we can do now is regulate the use of what was once private. At a minimum, the Universal Health Records database will ensure that you can see everything everybody else is seeing and have some say in its accuracy and utilization, which is orders of magnitudes better that the alternative.

Commedia dell'Arte

2012-01-03T10:03:00.000-06:00

"Accountability is something that is left when responsibility has been subtracted."
-- Pasi Sahlberg

This was the year when America turned on its doctors, and on itself. Not the 300 million citizens who are busy with other existential threats, but the elite 1% that effectively runs America, and the cadres of intellectuals who provide grant funded scientific cover to our leaders no matter how misguided they seem to be. Health care is a fiscal mess and someone, other than policy makers, must be held accountable. The greedy little doctors who are over treating us to enrich themselves are a good target and so are all of us greedy little people who refuse to go peacefully and expediently into the night. The same strategy is being applied to education, with the pathetic self-serving teachers obsessed with their benefits and the misfit children who ought to be cleaning toilets instead of learning, identified as the culprits for our educational fiasco. Mind you, the elite 1% is not experiencing either education failures for their children, or health care difficulties for their families. For them, this is not personal, it’s business, and they are about to make us an offer we can’t refuse.

A hundred years ago, give or take a couple of decades, America delegated the responsibility for taking care of the sick to the medical profession, and as science advanced by leaps and bounds, people were greatly rewarded with better health and longer life, and doctors were rewarded with prestige and financial prosperity. Some say too much prosperity, some say too little, but all in all, fewer than 10 cents of each health care dollar go to physicians. Professional responsibility for sick-care does not require one to be a saint and it is not necessarily incompatible with seeking higher remunerations for one’s services. However, something went very wrong along the way. Ever so gradually doctors have lost control of their profession to the rising corporate and public interests in health care who acquired complete jurisdiction over physicians’ reimbursements. Doctors became the servants of two masters, responsible for one and accountable to the other.

This obviously unworkable situation caused enormous problems during Managed Care I (the HMO). On the eve of Managed Care II (the ACO), our leaders are proposing, on behalf of the people, to release the medical profession from the moral and ethical responsibility which formed the foundation of the patient-doctor relationship and replace it with uniformly measurable accountability to public and private payers. Patients are advised to reject the old ways of paternalistic physician managed care, in favor of the empowerment afforded by payer, health system or employer managed care, which is certain to bring about better health care at lower costs everywhere except in Connecticut. Physicians, who enter apprenticeship as teenagers and graduate somewhere in their thirties, are having difficulty letting go of the historic burden of responsibility. Patients seem not to have read the official memo, and most are still expecting doctors to uphold their end of the ancient bargain. There are of course well publicized and well marketed exceptions.

While responsibility is entrusted, accountability must be managed, monitored and acted upon. From a patient’s perspective, the locus of trust must shift from the doctor to monitoring organizations. While the old trust was based on long term relationships, word of mouth or gut feelings, introducing much variability in outcomes, the new trust is based on facts, calculations and objective data, hence the controversial importance of Electronic Health Records (EHR), which are increasingly fitted to facilitate the transition from old to new. EHRs too are the servants of two masters, used by one and governed by the other.

Early EHRs were built and sold to doctors as tools to enhance practice revenue and personal income. Interestingly enough, very few physicians found that proposition enticing, and EHRs did not sell very well. Today’s EHRs are prescriptive data collection tools, with budding capabilities for reporting and exchanging information, and largely promissory abilities to deliver relevant evidence based protocols at the point of care. As the Meaningful Use incentives program enters its second year, physicians are increasingly purchasing and using EHRs. A minority is truly excited about a digital future, but the majority of EHR users, and practically all those still sitting on the sidelines seem to be asking the same question: how does this help with patient care? Well, it does, and it doesn’t, depending on what one means by patient care.

Most physicians are looking at EHRs as tools to help them do a better job. These doctors are still under the impression that they are at the center of health care delivery and EHRs are tools to assist them discharge their responsibilities to their patients. They are looking to computers to help search a medical record in intelligent ways, abstract all pertinent information and no more, manage repetitive tasks on their behalf, deliver timely reminders, provide advice upon request and become invisible when not needed - in short, the perfect butler. This is about hands-on patient care, one patient at a time.

Those who govern EHRs are continuously harmonizing them, through the Meaningful Use regulatory system, to promote accountability of EHR users. They need data. They need boxes to be clicked, numeric values to be captured and buttons to be pushed, and they need everything compiled and transported out to analytics engines to assess performance or lack thereof. They don’t need to know about Mary’s Lasix trouble, but they do need to calculate the p value from paired t-tests for the average change in percentages between baseline and subsequent years across patients qualifying for the measures. This is about standardized patient care at the population level.

Today’s EHRs have some features serving their users, but most development is geared to serve the governors and as a result, EHRs are not able to please either one of their masters. As Managed Care II blooms and the doctors for the 99% transition to accountability regimens, minding their p-values and t-tests, EHRs will become fabulous engines for enterprise data collection and processing. When the powers to be come to the realization that government intervention based on the assumption that people are irresponsible, greedy, dimwitted and largely inconsequential is doomed to fail, and Managed Care II joins its predecessor in the annals of failed policy, EHRs will finally become slick, intelligent and nonintrusive servants to both responsible doctors and their patients, helping deliver better health care at lower costs, one patient at a time, and by definition across the sum total of the people, because technology is not the limiting factor. Responsibility is.

The F Words of Health Care

2011-12-24T12:52:00.006-06:00

Vassily Kandinsky, 1923

Fragmentation, Fee-for-service and Futile care are the trifecta of what is supposedly ailing our health care system, or non-system, as it is fashionably described nowadays. Modern health care has reached its crisis point not due to hordes of people keeling over and dying in the streets, as they did during historical health care crises brought on by plagues and famine, but due to exploding costs of delivering decent care to all people. Since the issue now is mostly financial, health care as a discipline is attracting the interests of those who practice the dismal science of Economics. Over the last two centuries, economists have successfully addressed the F words in other industries with spectacular results in developed countries, so why not apply lessons learned to health care?

The obvious reason to treat economists with suspicion in health care is the quintessential argument that people are not widgets, but there is another problem. Most tried-and-true solutions for increasing availability and quality while lowering costs of products are not accounting for the other explosion occurring as we speak – the Internet. How can this assertion be true when we are in the midst of a government sponsored spending spree to computerize medical records and adopt Health Information Technology (HIT)? Apparently, even those who lead and define the HIT revolution are reluctant (or unable) to grasp its full implication, thus they are consistently underestimating the power of the Internet to serve the individual, and as a result are hedging their bets on technology with classic industrial models from days gone by.

In a 2008 Health Affairs article, Dr. Donald Berwick has defined what has become the official goal of policy making for the Secretary of Health and Human Services. Better known as the Triple Aim, the goals are to create better health, provide better care and lower costs of care. If you look at health care as just another industry, the Triple Aim translates into a better product with a better process at a lower cost. Well, when put this way, the solution is pretty obvious and it has been obvious for over two centuries. We must address the F words: eliminate Fragmentation by aggregating independent artisans in one physical location, stop paying Fee-for-service (piecework) and pay salaries instead, and most important, eliminate Futile work by standardizing the process. In short, apply the industrial revolution to health care and realize the economies of scale that brought prosperity and happiness to the developed world. Except that for some strange reason, this solution doesn’t quite work in health care.

Case in point: Federally Qualified Health Centers (FQHC). FQHCs started out in the early 1960s as community run clinics to provide medical care to the poor. By the mid-nineties, and with the best of intentions, the Federal government and the Centers for Medicare & Medicaid Services (CMS), created funding grants and reimbursement methods to support these clinics. Today there are thousands of FQHCs of different types, operating in health care shortage areas and providing team-based comprehensive care including preventative care, basic primary care, behavioral care, dental care, lab and pharmacy services, mostly to Medicaid beneficiaries and the uninsured, but also to small numbers of Medicare and privately insured patients. FQHCs must use mid-levels to provide and coordinate care and must report on quality measures. In return, FQHCs receive millions of dollars in grants for building and improvements, have access to cost effective workforce, can obtain free malpractice protection, are tax exempt and are paid more than double what a private practice is paid for Medicaid services. By all accounts, FQHC are addressing the triple Fs of health care rather well, but how are they doing against the Triple Aim objectives?

Studies are mixed regarding quality of care provided by FQHCs, and patients cared for by FQHC are largely sicker than those seen in private practice. Interestingly enough, neither Medicare, nor privately insured patients are flocking to FQHCs, in spite of the financial advantages offered, particularly to Medicare patients, and in spite of the spiffy state of the art facilities. This may, or may not be, an indicator for perceived quality of care. How about lowering costs? Do FQHCs provide care at a lower cost than, say, an independent solo private practice? Adding direct reimbursement rates, grants, tax breaks and other benefits, FQHCs visits cost more than twice the amount paid by Medicaid to private practices, which cannot compete with FQHCs and all but disappeared from areas where FQHCs operate. What would have been the results if twenty years ago CMS would have decided to increase Medicaid fees and pay for uninsured visits to independent practices, instead of exclusively backing the creation and operations of a separate but equal clinic system for the poor? We may never know for sure.

FQHCs are only a small example* of why economies of scale are not easily achieved in health care. Large hospital organizations and even fully integrated health systems, which may be providing better care (or not) seem equally incapable of reducing costs in spite of attacking all three Fs, or seeming to do so, and there are two reasons for this failure: a) larger health care facilities have disproportionately larger overhead costs and b) large systems are better equipped to charge more for services, which renders their efficiency efforts less urgent. And this is not a matter of opinion. CMS acknowledges this built-in inefficiency as evident in the physician fee schedule which pays an additional “facility fee” for services provided in hospital owned outpatient clinics, presumably to cover the extra overhead. Surprisingly, CMS is consistently creating incentives and regulations to accelerate provider consolidation into these big inefficient and expensive systems. The only possible explanation would be that CMS is betting that elimination of the last two Fs (Fee-for-service and Futile care) will be easier in a consolidated environment and the gains will ultimately exceed the losses from doing away with independent practice (Fragmentation). What about information technology? Well, it is supposed to help with process standardization, data collection and performance measurements, similar to what computers do in every other industry.

We have all seen the infomercials for high-tech hospitals, where a bunch of doctors are seated around a conference room table, each holding a laptop or tablet, presumably discussing patients in a team environment. There is something very wrong with these pictures. First, it costs us a fortune to have all these physicians in one room. Second, there is almost no added utility for them to be using computers instead of passing around a piece of paper, and computers are expensive. Third, there is no patient in the room. Now let’s imagine a different picture: a primary care physician sitting in his office, with a patient next to him, both interacting with a computer on which a Skype conference is taking place with an oncologist sitting in his own office thirty miles away, a surgeon in a hospital lounge in the city and perhaps a radiologist half a continent away. Everybody on the call has access to the same electronic medical record, appointments can be made in real time, literature can be consulted and shared, prescriptions can be changed and a common care plan agreed upon by all and understood by all can be created and by using intelligent predictive analytics tools various options can be explored. Perhaps a family member in a different country is conferenced in and perhaps the patient is at home or in a break room at work. Perhaps there’s an electronic sign-up sheet for the oncologist, if the patient wants to ask something else later and have a physician friend in New Zealand listen in. And with one click on a PayPal button all doctors are paid for their time.

In this Internet age, manufacturing style physical consolidation is not only unnecessary, it is cost prohibitive. Modern lifestyles and modern medicine have created a need for doctors and patients to collaborate and the Internet is providing the means to accomplish such collaboration without having to physically gather everybody under one expensive roof. There is no need to obliterate the operational efficiencies of private practice and replace it with the bloated bureaucracy of large institutions, and there is no need to dispense with long lasting doctor-patient relationships in favor of computerized care coordination, and there is absolutely no need to substitute a bunch of numbers in a computer for a real patient. The Internet is decentralizing and individualizing everything from politics to manufacturing. Health care is, and always has been, decentralized, individualized and based on the local patient-doctor dyad. The resemblance is striking. We either embrace the fully aligned collaborative nature of the Internet to achieve better health, better care at lower costs, or engage in a doomed effort to impose an unnatural centralized command and control structure in health care just because it worked well for nineteen century steel manufacturing and because policy makers don’t truly understand the magnitude of the connectivity revolution.

* According to the Kaiser Family Foundation FQHCs had about $12.7 Billion in revenues in 2010, 75% of which came from Federal and State agencies. They served almost 19.5 million patients with over 77 million encounters. Simple math yields a cost of approximately $165 per encounter.

The Pin Factory EHR

2011-12-05T18:12:00.000-06:00

In 1776 Adam Smith explained to posterity how specialization increases productivity using the now famous example of a pin factory. While one master pin maker could turn out anywhere between 1 and 20 pins each day, going through all the steps involved in making pins all by himself, a specialized army of laborers, each fulfilling one step in the pin making process, could increase productivity more than two hundred fold and turn out almost 5000 pins per person per day. This would have the triple benefit of enriching the factory owner, creating jobs and making pins both affordable and widely available for consumers. What happened to the master pin maker, who used to make a very nice living when pins were expensive and hard to come by? He would most likely be employed in the factory to supervise the smooth flow and quality of the new pin mass production system. He would make sure that each laborer works at a speed appropriate for feeding the next laborer in line and he would probably sample a few pins here and there to make sure they are as sharp and sturdy as the ones he used to make in the olden days. When the master pin maker passes away a new supervisor would be hired, most likely one that has never made an entire pin before, but instead has a much better understanding of the production process. The profession of pin coordinator has been born.

Although Adam Smith put forward the notion of specialized labor, Henry Ford is customarily credited with the invention of the modern assembly line. Interestingly, Ford is attributing his invention to the observation of Chicago’s meat packing industry. It seems that while no two cows are identical, the butchering of animal life lends itself rather well to disassembly line methodology. Today, manufacturing assembly lines use human labor where it is cheap and in abundant supply, and are staffed with robotic machinery where human labor is expensive and/or scarce. In all cases the process is orchestrated and controlled by sophisticated computer software. This is why we are all able to purchase a car, chat on our cell phones and enjoy perpetually fresh slices of white bread in plastic bags, amongst many other wonderful things, which were once only available to the wealthy few.

Modern medical care is increasingly out of reach of most people. It is expensive, and adequate resources are scarce in many areas. Medical care also varies widely in quality, and the costs of production are anybody’s best guess, depending on geography, time of year and even workers vacation and education schedules. This is very much the same as making pins in the eighteen century. In all fairness, some specialization of labor has already occurred in medicine, but there is no coherent method of placing each worker in his/her station of the continuum of care, and there is no standard process by which workers hand off work from station to station. According to experts, this lack of orderly processing, along with the absence of quality control, is creating a terrible waste of resources and a flurry of defects in the finished products. If the advanced methodologies of modern day manufacturing are working so well for everything from cars to pins to cows, wouldn’t it make sense that we should at least try them in medicine?

Fortunately, we already have several pieces of the puzzle in the works. As mentioned above, we do have a certain degree of specialization in medical practice. We also have hospitals, which could function very much like factories, but as Clayton Christensen observes, most have no well-defined assembly lines. And then, of course, we still have the independent small shops that take piece-work home and operate without any standardized quality control. We also have the beginnings of computerized control systems in the form of Electronic Health Records (EHRs), which, according to John Halamka, are quickly moving from just bookkeeping software to dynamic coordination of processes, complete with encyclopedic knowledge of medicine and a good measure of artificial intelligence to devise and “enforce automated care plans”.

The only thing left to do is to lay out proper assembly lines, and we don’t really need to think outside the box too much, because manufacturing has solutions for this dilemma as well. In modern industry, there are practically no factories that start out with raw materials and end up with a finished product. Instead, some factories concentrate on producing parts and others are built to receive parts and assemble them into useful products. Exact specifications for each part, to be followed by production lines and relied upon by assembly lines, make this geographically dispersed process possible. In health care, the primary care homes will serve as production centers, where people are constantly measured, tracked, tested and evaluated, so when they are finally shipped to a hospital for a procedure, the hospital knows immediately which assembly line to place them on and the omniscient EHR will control the most minute detail in the process, from medication dosing to incision size and implantable device brand and model, thus reducing both errors and costs. Once the hospital’s work is done, patients are released back to evaluation and management in production centers, and here is where the cyclical nature of health care differs from a typical manufacturing process, and this is why it is extremely important that EHRs be interconnected and preferably Cloud based to achieve a high degree of omnipresence.

Yes, there are many more details to be worked out, like emergencies, accidents and the exact specifications that an EHR should contain on each type of person. We will have to establish quality feedback loops between hospitals and primary care centers to continuously refine processes for both entity types, so basically the EHR will need to be able to adapt to, and learn from, new information, in a manner similar to IBM’s Watson software. Since people are not pins or even cars, the tolerance levels (allowed deviation from specs) will be high initially, so line workers will need to be highly skilled as well. In all likelihood physicians will be working those lines for the foreseeable future. As the learning control system improves, portions of work would be offloaded to less skilled resources and eventually to machines, and more significantly, entire tasks could be packaged into deterministic protocols and pushed out from expensive hospitals to the less skilled primary care production centers, which will further push the most trivial tasks to consumer owned devices.

Obviously, EHRs will prove to be the heart, brain and circulatory system, of the health care industry. As we speak, EHRs are increasingly being tasked with care coordination activities (not to be confused with continuity of care, or longitudinal care), which are the precursor to the industrial line controller. Folks wondering why they should use EHRs that are not ready for prime time, should understand that we have to have an EHR in every practice, so that the system can have visibility into current processes to learn, adapt, grow and devise new methods of providing care. After all, you cannot control that which you cannot see.

If you think this is all farfetched and disastrous, please find a senior citizen that lived through the Great Depression and ask her what she thinks about dinner being prepared moths in advance in computer controlled industrial vats, thousands of miles away from home, pumped full of preserving chemicals, freeze dried, shrink wrapped and delivered by airplane to a football field size department store, with minimal human intervention, ending up in a small irradiation chamber in your home before it hits your dining table (or couch). Yet we all buy the stuff and feed it to our kids with no apologies, because it is cheaper, faster and more convenient than tenderly preparing beef stroganoff and baking pot pie at home, after work, every day. And neither grandma nor you can even fathom the handcrafting of pins by master artisans. Is health care really that much different?

2011 EHR Adoption Rates

2011-12-01T11:16:00.001-06:00

On Wednesday, November 30, the Centers for Disease Control and Prevention (CDC) released the results of its yearly survey on Electronic Health Records (EHR) adoption for office-based physicians. No surprises. Generally speaking, the majority of physicians in ambulatory practice are now using an EHR, and over half of surveyed doctors say that they intend to seek Meaningful Use incentives. The report is also presenting results broken down by State, so you can learn what folks are doing in your immediate vicinity. The more instructive exercise is to compare last year’s survey results [Fig. 1] to this year’s estimated EHR adoption numbers [Fig. 2].

Figure 1: Percentage of office-based based physicians with EHR - 2010

Figure 2: Percentage of office-based physicians with EHR - 2011

The most immediate observation is that 6.2% of physicians have adopted an EHR in 2011, thus returning to EHR growth rates preceding the 2009 -2010 slowdown, which was largely due to the confusion created by Meaningful Use regulations. The next observation is that the percentage of docs that have at least a basic EHR has gone up by 8.9% in 2011. A basic EHR is one that has “patient history and demographics, patient problem list, physician clinical notes, comprehensive list of patient's medications and allergies, computerized orders for prescriptions, and ability to view laboratory and imaging results electronically”. Although the survey instrument in 2011 did ask about more advanced functionality, and is practically identical to the 2010 instrument, the CDC did not publish a separate number for those with fully functional systems in 2011. Although I cannot be certain, I would assume that most of the growth in 2011 was fueled by Certified EHRs, which by definition should be fully functional. So if I had to guess, and I hope CDC will release the numbers so I don’t have to, I would estimate that in 2011 we have at least 20% of physicians using fully functional systems, which is roughly double what we had in 2010.

Another interesting trend that has been holding since around 2007 is that about a quarter of office-based doctors have some type of bare bones software in their office and they are not upgrading to even a basic EHR. Considering that over half of those surveyed intend to apply for Meaningful Use incentives, this trend is bound to change in 2012. Some of these folks may have purchased a fully featured EHR, but chose to either not turn features on or chose not to keep up with upgrades to newer versions. For ambulatory EHR vendors these numbers translate into a market opportunity ranging from 50% of the market to a full 80% of ambulatory physicians.

It would be very beneficial if CDC released the complete data set from this survey (anonymised, of course), so we could gain a better understanding of EHR adoption patterns by practice type, size and location. Although it is widely acknowledged that larger practices and employed physicians are further along the curve, the rich details provided by the survey instrument should help both vendors and various organizations engaged in efforts to spur technology adoption, better target their work, and it could also illuminate any disparities which may affect quality of care for vulnerable populations and physicians who serve them.

In summary, the new CDC survey is showing a stable growth in technology use by office-based physicians, modestly improved by government initiatives over the last two years, and well positioned to further improve in 2012 and beyond.

Thanksgiving in Health Care

2011-11-20T21:03:00.001-06:00

Thanksgiving is almost here and between shopping for yams and turkeys and waiting for the cranberries to pop in the saucepan, there is ample time for reflection. Most folks evaluate the past year and make predictions for the next somewhere around Christmas, but since little serious business is conducted after Thanksgiving, and I’d rather leave predictions to professional gamblers, this is the week where I sift through this year’s events and try very hard to elicit personal feelings of gratitude. Since this is a health care blog, here are some health care related things I am very thankful for, and since like most social media aficionados, I too have a very short attention span, most are rather recent events.

First and foremost I would like to thank the Supreme Court of the United States for agreeing to hear arguments from the States, the Federal Government and small businesses backed by large businesses, on the Patient Protection and Affordable Care Act (PPACA) (a.k.a. Obamacare). Although having PPACA end up in front of the Supreme Court was a foregone conclusion since before the ink was dry on the President’s signature, and perhaps long before that, I am particularly grateful for the Supreme Court’s chosen timing for making a decision on this matter. The Court will hear arguments early in the spring of 2012, and if all goes according to plan it will either uphold or obliterate President Obama’s most important policy achievement just in time to inform my decision on who to vote for in the Presidential elections. It means a lot to me, and I am sure to many other conflicted voters, to have the advice of the wisest nine men and women in the land, and it is much more elegant and efficient to mentor us now instead of having to fix the issue after the elections take place.
Second, I would like to express my gratitude to Walmart who is finally volunteering to extend its unparalleled efficiencies in supply chain management to health care. Like most Americans, I have seen my health insurance premium go up by almost 20% recently and my deductible has too many zeros to fit in that little box on a standard check. It is reassuring to know that very soon Walmart will do for health care what it did for tee-shirts and accessories. Obviously, any organization that can put a plastic Luis Vuitton handbag in the hands of the humblest day laborer can surely be relied upon to bring PSA testing and chronic disease management to every hamlet and every housing project in the land. And even though I have no plans to start shopping at Walmart, particularly for health care, I am looking forward to the proven Walmart effect on prices of medical products and wages, which should make all health care, affordable for all of us.
On a more technical, and more work related note, I need to thank the FDA for unequivocally excluding Electronic Health Records (EHR) from its proposed regulation of mobile medical applications. The mobile health (mHealth) field is in its infancy and chock full of bright eyed and bushy tailed young entrepreneurs who can obviously benefit from FDA guidance just like their brethren in the perpetually sizzling bio-tech and device industry already do, with more innovation than any investor can handle percolating up all day every day. On the other hand, the frail and elderly EHR field, led by billion dollar technology and insurance companies, is in no position to withstand the rigors of FDA regulatory activities, which may inadvertently interfere with the massive life supporting cash infusion from government initiatives.
For a closely related effort, I am also grateful to the Institute of Medicine (IOM) for its recent report supporting the FDA position on EHR regulation. While acknowledging the inherent patient safety issues posed by use of EHR devices, the IOM is proposing a tangled web of voluntary and non-regulatory boards and organizations to be created for the purpose of observing and guiding EHR product use and development. The IOM does recognize that the system it proposes may very well fail to address the issue at hand, in which case it recommends that the FDA comes in to the rescue as a last resort. Hopefully by then EHR companies will have had every chance to absorb the Federal flow of cash to the industry in its entirety.
A few days ago we observed Veterans Day and we all expressed our heartfelt thanks for the sacrifices made by our men and women in the armed services. I would also like to thank Congress and its Super Committees for going above and beyond gratitude, and actively trying to provide our Veterans, even those who are too old, too depressed or otherwise incapacitated, with one more chance to serve our country. As we sink deeper and deeper in debt, there is a great opportunity for millions of heroes to forgo a little bit of health care services, or pay a bit more for each, so the greatest nation on earth can save a whopping $11 billion each year. Compared to putting oneself in harm’s way, this is easy stuff and while it is true that one large corporation, like GE for example, could single handedly create those savings just by paying their taxes for the year, it is much more meaningful that the glory should go to our Veterans. It is the right thing to do and I am so proud of our honorable members of Congress.
Finally, I would like to thank Congress one more time for perhaps the most extraordinary achievement in its history, and that is transforming pizza into a vegetable. Granted the Supreme Court of 1893 paved the way by declaring the tomato fruit to be a vegetable, but combining white flour and globs of animal fat into the texture of this new vegetable is nothing short of miraculous. Although Congress accomplished this in the context of ensuring that our children eat healthy food in school cafeterias, I am certain that many adults and most children will incorporate more of this wonderfully healthy vegetable in their diets outside of school lunch, and I for one, will try very hard to find a creative way to add this Congressional vegetable to our Thanksgiving table this year.

Now that I thanked all I could think of, and before I return to my bubbling cranberry sauce, I would like to ask for one little thing. Bypassing the Congressional middlemen, and going straight to the top, I would like to ask Hershey and Nestlé and all other multi-national decision makers, if it would be possible to make chocolate a vegetable too. Since cocoa beans grow on trees, chocolate is practically a fruit as it is, so making it a vegetable should be trivial in view of the various precedents quoted above, and it would mean so much to me and to countless other women and children trying hard to take personal responsibility for their own health and health care.
Happy Thanksgiving everybody!

The IOM Report on Health IT Safety

2011-11-09T12:48:00.000-06:00

A recent report from the Institute of Medicine (IOM), “Health IT and Patient Safety: Building Safer Systems for Better Care”, introduces a new health care related term, "Health IT-assisted care", defined as "health care and services that incorporate and take advantage of health information technologies and health information exchange for the purpose of improving the processes and outcomes of health care services. Health IT–assisted care includes care supported by and involving EHRs, clinical decision support, computerized provider order entry, health information exchange, patient engagement technologies, and other health information technology used in clinical care”. And the IOM report, as its title implies, is recommending strategies to ensure that health IT-assisted care is safe for patients.

The IOM report presents a comprehensive literature review regarding the status of health IT as it pertains to patient safety from every conceivable angle, starting with the manufacturing process and drilling down into product selection, implementation processes, training, and actual use of EHRs and other health IT products. As most folks who follow the health IT industry know all too well, the report concludes that data concerning the effects of health IT on patient safety is currently scarce and inconclusive. Nevertheless, the scarcity of data and the “sparse evidence pertaining to the volume and types of patient safety risks related to health IT” did not prevent the committee from acquiring “the sense that potentially harmful situations and adverse events caused by IT were often not recognized and, even when they were recognized, usually not reported”. That maybe so and again it may be that what we see is all there is to see. Either way, “[t]he committee believes the current state of safety and health IT is not acceptable; specificactions[sic] are required to improve the safety of health IT”. To that end, the report presents 10 recommendations to the Secretary of Health and Human Services (HHS).

HHS should create and publish an action plan in the next 12 months to assess the risk of health IT for patient safety and begin mitigation through education, research, standardization and the testing and accreditation of health IT products. Suggested organizations for funding and carrying out these activities are ONC, AHRQ and NLM.
HHS should insure that health IT vendors freely exchange information regarding issues as they pertain to patient safety. This is where the infamous gag clauses in EHR contracts should be addressed.
ONC should work with public and private sectors to make user reports of patient safety issues publicly available. NCQA and JCAHO are amongst the suggested implementers.
HHS should fund the creation of a new Health IT Safety Council to evaluate criteria for measuring safety of health IT.
ONC should require all health IT vendors to publicly register with the agency.
HHS should define mandatory quality management processes for health IT vendors. ONC, FDA and certification bodies are suggested organizations for administering a compliance process.
HHS should establish a mechanism for reporting adverse events which is mandatory for vendors and voluntary for users. Reports should be collected analyzed and acted upon.
Congress should create an independent federal entity, similar to the National Transportation Safety Board (NTSB), to investigate the reports collected in item 7 above.
HHS should monitor progress and if found lacking, should direct the FDA to exercise its full authority to regulate health IT. The FDA should immediately begin preparing the infrastructure for this eventuality.
HHS should support cross disciplinary research of safety aspects of health IT, such as user centered design, safe implementation methods, sociotechnical systems, and effects of policy decisions on health IT.

This is a very impressive and very well-reasoned list of tactical and strategic initiatives, but it also presents some difficulties. First, reporting adverse events is a prerequisite to almost all activities recommended by the committee. It is not clear how such reporting is to be implemented when malpractice suits are a consideration. The report suggests that reports should be kept private, even anonymised, and that users should be protected from punitive actions. Does this protection extend to legal action? If the report-collection agency becomes aware that a patient died due to preventable error, should the patient’s family be notified? Should malpractice attorneys be allowed to review this public information and subpoena the identifiable data? Second, all ten recommendations made by IOM require significant funding and it is not clear where the monies should come from at the moment. The recommendation in item 9 above, that the FDA readies itself for full regulation of health IT as a contingency plan if all else fails, seems duplicative and particularly wasteful. Somehow the committee seems to believe that FDA regulation, unlike regulation by multiple disjointed organizations, would negatively affect anticipated innovation in health IT.

Speaking of the FDA, the immediate question, of course, is why do we need a 137 page report from the IOM to figure out how and who should oversee patient safety? The Food and Drug Administration (FDA) is currently overseeing patient safety issues arising from surgery-assisted care, radiology-assisted care, pharmaceutical-assisted care, implantable device-assisted care and all sorts of other types of assisted care. Most recently the FDA published its proposal to oversee mobile device-assisted care (phones, tablets and laptops). How and why is health IT-assisted care different? How is a medication dosing calculator on an iPhone different than the same calculator in an EHR? How is an iPhone connected to a blood pressure cuff different than an EHR connected to a blood pressure cuff?

To my immeasurable delight, the IOM report contains the answer in the Dissent Statement of Dr. Richard Cook. While the IOM report is recommending that health IT be regulated and monitored by a smorgasbord of existing or yet to be created organizations, none of which have the required expertise to tackle the task, and all of which will need to be heavily funded for this endeavor, with the FDA as a last resort measure, Dr. Cook proposes to allow the FDA to do its job in the first place. Dr. Cook’s simple and straightforward recommendation is to have HHS “direct the FDA to exercise its authority to regulate health IT, including all EHRs and associated components, and health information exchanges, as Class III medical devices”. While possessing all salient characteristics of a Class III device, “health IT is on track to be a medical device used for every person in the United States” [italics in the original], which makes it both urgent and imperative to have health IT regulated and monitored properly and Dr. Cook's conclusion succinctly sums it all up: "health IT is a medical device. It should be regulated as a medical device now and should have been regulated as a medical device in the past".

EHR Adoption is Like Treating Cancer

2011-10-30T23:34:00.000-05:00

EHRs are not ready for prime time. EHR benefits are questionable and there are documented instances where patients’ deaths were directly attributed to an EHR. EHRs are cumbersome and slow. They are unnecessarily complex and built on very old technology. The people who build EHRs have no concern for the end user and therefore EHR usability is pretty abysmal. And EHRs are expensive to buy and expensive to maintain, not to mention that they can completely derail your practice through loss of productivity. The fact that some users seem to do well with their EHRs, and even derive some joy from using them, is not a valid counter argument since most users are not so fortunate and through no fault of their own. There really is no excuse for such failure in this day and age. Just look at the iPad and the iPhone. You can walk into any Apple store and 5 minutes later walk out with a fully functional product with a delightful, intuitive interface, loaded with hundreds of interchangeable apps that even a three year old can use right out of the box. All for a few hundred bucks.

If you happen to be diagnosed with cancer, you will most likely be subjected to years of unpleasant treatments. You will be injected with poison and irradiated with more poison. You will lose your hair, suffer bouts of vomiting and diarrhea and be physically debilitated to the point where you cannot leave your bed. You will most likely have to go through painful surgeries, take all sorts of medications that were shown to kill thousands of rodents and never recover your old self again. And this entire ordeal will cost you a medium size fortune. The fact that some lucky patients go on to win the Tour de France is not really an acceptable rebuttal. Most do not. And there really is no excuse for such incompetence in this day and age when one little pill can cure you of an yeast infection in 24 hours and a $4 course of antibiotics will render you as good as new if you happen to develop a sinus infection. Not to mention the innumerable vaccines that will miraculously prevent you from contracting the plague.

Yes, this is a farfetched analogy, but replacing paper charts with an EHR is not like playing Angry Birds, and if you want a fair chance at survival, you have to tolerate the side effects imposed by the current state of technology. Just like you cannot postpone your cancer treatment until the doctor from Star Trek figures it all out, you cannot postpone transition to EHR until EHRs are “ready for prime time”. And make no mistake, in today’s reality, paper charts are as big a threat to the survival of an independent medical practice, as any garden variety cancer is to a human body. Paper charts will gradually and irreversibly deprive your practice from the nutrients and oxygen needed for survival, i.e. reimbursement, until it shrivels and dies, or it gets absorbed into a larger organism. The common wisdom seems to favor these outcomes. I do not. If you are one of the fewer and fewer physicians who has no desire to either shrivel or practice Wal-Mart medicine, here is one way to think about your current EHR predicament. [Note: Considering the gravity of the situation, you would be well advised to seek a second opinion.]

Diagnosis – Look around you. EHRs are slowly gaining ground. You would be hard pressed to find a medical group of significant size that does not have one. Data collection is not as voluntary as it is being portrayed, unless of course you think that you are overpaid and can easily absorb cuts in reimbursement. You can choose to make believe that this too shall pass and once Obama is no longer calling the White House home, all will be as it was. Alas, computerization of medical records has bipartisan support, and it always did, due to a rare alignment of powerful financial interests and progressive ideology. If you want to continue the practice of medicine, you will need to use the tools of the trade. For better or worse, both the trade and its tools are being redefined. Barring a global disaster, the chances of spontaneous remission are nil.

Staging – How bad is it doc? Well, it won’t kill you tomorrow, but the longer you wait, the harder and more expensive it will become, the fewer the choices and the lower the chances of a good outcome. Both public and private payers are experimenting with new reimbursement methods. These pilots, or projects, are cropping up everywhere, supported by grants and all sorts of tax payer monies. The goals may be different and the rules of engagement are certainly different, but these arrangements have one thing in common. They all prefer that you generate and consume large amounts of clinical data in electronic format. You will need an EHR for that.

Treatment – A physician-centered approach to the problem suggests that you should be informed of your options and allowed to make a decision based on your personal and cultural preferences. Since medical practices are not people, you may choose to euthanize your practice. This may make perfect sense if your practice had a long and productive life and your medical career is in its twilight years anyway. A less terminal option would be to allow your practice to be hooked up to the machinery available in large health systems. You will still have to use an EHR, but your new employer will undertake the mitigation of most side effects. There is a slim chance that someday you may be able to remove the tubes and resume private practice, but while your medical career can survive indefinitely, your practice as you know it now is not likely to recover. Or you could make a stand and fight for your independence.

Prognosis – By definition there could be no blinded trials for EHR utilization, and by omission there are no randomized control trial results to learn from. The anecdotal evidence suggests that many thousands of physicians in independent practice are surviving just fine after EHR implementation. Some would say that they are doing better than ever now, and others have resigned to the new ways of doing business. For most, the life threatening problem has been transformed into a manageable chronic condition. It must be noted however, that a significant number of physicians is currently in need of life-support from health systems and hospitals, and many of these are post EHR implementation. We cannot be certain, since there is almost no literature on the subject, but it is highly probable that practices suffering from a relapse have had multiple comorbidities to start with and/or developed other life threatening conditions since. There are no guarantees of course, but if you have an otherwise healthy practice, a positive outlook and a supportive environment, chances are good that transition to EHR now will enable your independent practice to survive and thrive for many years to come. And the opposite is also true.

EHR Bargains Review – Practice Fusion

2011-10-16T20:50:00.002-05:00

(Survival Tips for Small Practices)

If you subscribe to Prof. Clayton Christensen’s theories of innovation, Practice Fusion is to the EHR industry what Southwest Airlines was to the air travel industry, ad extremis, with no thrills, no frills and no peanuts. Practice Fusion is completely and truly free to users, and it will take you from point A to point B in a straight and short line, with point A being paper charts and point B being a Meaningful Use incentive check.

The Model

Practice Fusion is a web-based EHR and it is free to use no matter who you are. The company website has a self-provisioning button where any visitor can sign up for a free account and immediately start using the software. All you need is a valid email address. The company prides itself in taking users live on the EHR in 5 minutes. It actually takes much less than 5 minutes to get to a point where you can begin charting, but it takes a week or more to hook up to electronic prescribing and lab interfaces, and this is very much in line with industry practice. Practice Fusion offers free connectivity to national reference labs and a handful of regional ones as well. Just like there are no charges for electronic prescribing, there are no interface fees for the currently available lab connections and no mention of “custom” interfaces built for a fee. You get only what you see.

Since we all know that there is no free lunch, how is it possible to get a free EHR, including significant interoperability? The standard answer to this is that Practice Fusion is ad supported. Just like you get free email services from Google in return for agreeing to see ads on every email page, when you sign up for Practice Fusion, you are agreeing to see ads on every EHR page. To my pleasant surprise, the ads are mostly limited to about one inch of space at the bottom of the screen, and are not at all intrusive in the workflow. I actually don’t quite see how these ads support anything, since with the exception of one Dell advertisement they all seem to be Practice Fusion self-promotions. Furthermore, the fairly new Patient Fusion portal displays no ads at all. Similar to most other EHRs, the Practice Fusion end user agreement reserves the right for the vendor to aggregate and monetize EHR data, and perhaps this is a possible explanation for this free lunch.

Functionality

The best description for Practice Fusion’s functionality is bare-bones. There is no fluff, no bells and no whistles to be found in the very simple, very clean user interface. After muddling through a variety of top-shelf EHRs with double and triple menu-bars and icon studded task-bars on every page, the Spartan look & feel of Practice Fusion is quite refreshing. Although there are multiple training aids in the system, if you are an average computer user (e.g. email, Word), you should not need much coaching to become productive at very short notice. This of course eliminates another hefty expense associated with EHR adoption: training.

Whatever free-form stuff you are now doing on paper, you can do in Practice Fusion, pretty much the same way. It comes with a simple set of SOAP templates consisting mostly of questions where you get to type in the free text response. You can also type directly into the note and probably use Dragon as well. You can create your own sets of questions, or add to existing ones. You can order meds, labs and imaging and print those, or send electronically if connected. Scanned documents can be uploaded to any particular chart. There is no clinical content available for decision support, at this time. Registry functions are in their infancy and the handful of available reports is very simplistic. Disappointingly, the Meaningful Use report does not automatically calculate numerators and denominators for core and menu items, but clinical quality reporting is automated. There is very little customization possible and none is required.

For patients, there is Patient Fusion, a simple web-based portal that allows patients to see appointments, meds, allergies, immunizations and labs. It also provides some links to medical content on the web. It seems that the portal is very much a work in progress, but just like the EHR, its user interface is clean, simple and appealing. Unlike the EHR, which is Flash based and therefore unavailable for use on Apple mobile devices, the portal is accessible from an iPhone or an iPad. Practice Fusion did announce recently that a native version of its EHR for the iPhone is due to be released soon.

Viability

Practice Fusion is privately owned and has been around since 2005, but started taking off in earnest around 2009. Its recent growth coincides with the HITECH act and the advent of Meaningful Use. Although it is possible that it will follow a trajectory similar to Southwest Airlines and blossom into a major EHR vendor, it is also possible that it would make a rather attractive acquisition target for one of the much bigger fish circling health care IT right now. Will it remain free to end users? There seems to be no current intent to charge customers for software usage, but Practice Fusion received over $36 million in venture capital, which usually comes with expectations of short term spectacular returns. Time will tell.

Bottom Line

Practice Fusion is currently certified for Meaningful use as a Complete EHR, which means that you don’t have to buy additional software in order to achieve Meaningful Use requirements. As is the case with all web-based EHRs, you will have to buy desktop (or mobile) hardware, internet services and networking hardware. You will still need to pay for a Practice Management system and billing, and unless you choose to utilize the sole Practice Fusion partner for these activities, you will need to budget staff time for double data entry. You will not need to pay for the EHR, its server and its maintenance. If you are interested in Meaningful Use incentives, and if you practice in a small group, and if the cost of EHR seems prohibitive (or a waste of good money), and if you have no use for bells and whistles above and beyond a paper chart, then by all means, go ahead and try it out. It’s free.

Occupy Health Care

2011-10-14T14:36:00.000-05:00

Earlier this year, in the midst of the civil unrest in Egypt, Michael Millenson pondered about the passive attitude of those lacking health care insurance and their failure to organize and “take to the streets”. Well, unless you are living under a rock, or are really busy seeing patients, you know that we have quite a few people “taking to the streets” nowadays. They call themselves the 99% and they are set to Occupy Wall Street along with a bunch of other cities across the country. They have been called everything from “the rise of a popular movement” to “anti-American”. Are these Michael Millenson’s uninsured finally standing up for themselves? Judging from the stories they write on the placards covering their faces, which look eerily similar to what you see at busy urban intersections (e.g. “Lost home and job, will work for food”), lack of health insurance is often cited as a source of misery, but so are student loans, lost savings and inability to find work. Although this peaceful movement of folks camping out in parks and marching down streets has no coherent message, their grievances are casting a large net directed at the destructive influence of Wall Street, big corporations and consumerism in general. Michael Millenson should be satisfied, since health care is most definitely included in this all-encompassing indictment of an unjust society, and here is why.

But first a little detour into terminology. The word “care” originates from the Old English caru, cearu "sorrow, anxiety, grief," also "serious mental attention" for the noun, and carian, cearian "be anxious, grieve; to feel concern or interest" for the verb. When it comes to one’s health, with the exception of patients, their loved ones and increasingly fewer and fewer doctors, nobody in the medical complex experiences any feelings of anxiety, grief or even true interest or concern for the sick, although they may experience all of the above for the cash flow associated with treating sick people. The term health care is an anachronism from a bygone era and it needs to be changed. Health Services seems a much better fit with the prevailing consumer philosophy, which brings us to the next point.

Ever so gradually and insidiously, the term consumer is replacing the term patient in health services contexts, just like it replaced the term people in larger contexts. The etymology for the word consumer dates back to the early 15th century as "one who squanders or wastes", and in economic sense, "one who uses up goods or articles (opposite of producer) from 1745”. Interestingly enough those who presumably advocate for poor and vulnerable populations and even our own government are enthusiastically standing up for their constituencies of squanderers and wasters. Sometimes terminology describes existing realities and sometimes carefully chosen terminology shapes reality. We are witnessing the latter. The big corporations being targeted by those who Occupy Wall Street, have a long, and productive, history of manipulating the 99% into using up as many goods and articles as possible, and then some (i.e. debt), while extracting both profit and power from an increasingly impoverished society. Squandering and wasting is the secret sauce for a consumerist world order, and the medical complex is no different. According to Forbes, in the midst of a recession, CEO pay has increased in 2011 by 28% compared to 2010. The highest paid CEO in America, at $131 million per year (twice as much as the second CEO on the list), is running a health services company. Makes perfect sense. After all health services are quickly approaching 20% of a successful wasting and squandering economy. $131 million is peanuts by comparison.

But here the big corporations are encountering a big problem. The U.S. government, that is supporting a large portion of the waste and squander in the health services sector, is running out of money, and the squanderers themselves seem unwilling to waste their own money on health services. They much rather debt finance homes, cars and iPhones than, say, colonoscopies and designer drugs. The solution to this quandary is a brilliant one-two punch. First we use the bought and paid for government to educate consumers that in a world of finite resources, after skimming the $131 million type “compensations” from the top, only those who have their own resources (i.e. cash) should expect to continue wasting and squandering health services. Second, to compensate for lost revenue from government’s support of health services consumption, we employ two, time tested, strategies. We convert non-consumers to consumers by giving them free small things to lure them into buying more expensive items. For example, we give out free cholesterol screenings so we can create a recurring revenue stream from statins and hopefully more expensive interventions down the road. After all there is a huge untapped market of 50% of Americans who barely use any health services. Then we increase the prices of everything from health insurance to direct services, by eliminate those obnoxious small businesses floundering in this space and fragmenting our ability to negotiate higher prices. The government is of course expected to help with the necessary laws and regulations, and so far, keep your fingers crossed, it’s going rather well. With a little bit of luck, smart consumers will soon realize that it is in their best interest to spend money they don’t have on the medical complex rather than the real estate market, which has gotten more than its share already, or the high tech gadget market which is booming, or the automotive market which is dead anyway (except for Audi who is selling cars for a crumbling infrastructure littered with trash). It’s all about reallocating extortion revenue and nobody is in a better position to do that than the medical complex. Brilliant indeed.

As the ancient prophet said “What has been will be again, what has been done will be done again; there is nothing new under the sun” [Ecclesiastes 1:9], all of the above has been tried before, in this case by the legendary Mullah Nasreddin, and we know how it ends:

One winter Nasreddin had very little money. His crops had been very bad that year, and he had to live very cheaply. He gave his donkey less food, and when after two days the donkey looked just the same, he said to himself, "The donkey was used to eating a lot. Now he is quickly getting used to eating less; and soon he will get used to living on almost nothing."
Each day Nasreddin gave the donkey a little less food, until it was hardly eating anything. Then one day, when the donkey was going to market with a loan[sic] of wood on its back, it suddenly died. "How unlucky I am," said Nasreddin. "Just when my donkey had got used to eating hardly anything, it came to the end of its days in this world."

To the 99% of us donkeys out there: Occupy Health Care Now!

The Rise of Big Data

2011-10-09T18:20:00.000-05:00

Health care is in the process of getting itself computerized. Fashionably late to the party, health care is making a big entrance into the information age, because health care is well positioned to become a big player in the ongoing Big Data game. In case you haven’t noticed computerized health care, which used to be the realm of obscure and mostly small companies, is now attracting interest from household names such as IBM, Google, AT&T, Verizon and Microsoft, just to name a few. The amount and quality of Big Data that health care can bring to the table is tremendous and it complements the business activities of many large technology players. We all know about paper charts currently being transformed via electronic medical records to computerized data, but what exactly is Big Data? Is it lots and lots of data? Yes, but that’s not all it is.

Americans live for approximately 78 years. They see a doctor about 4 times per year and spend on average 0.6 days each year in a hospital. To keep a life time record of blood pressure readings for all Americans, including metadata (date/time of reading, who recorded the measure and where, etc.) takes approximately 6 TB (terabytes) of storage space, or about 12 laptops with standard 600 GB hard drives. Not too big. What if we start using mobile wearable devices to quantify ourselves, as some folks already do, and we record blood pressure, say, every hour? We will require 1460 TB of storage, or almost 3000 laptops, or the equivalent of 6 times the digitized contents of the Library of Congress, and this is for blood pressure monitoring only. Adding in the remaining 99.9% of the medical record, including large imaging files, hospital monitoring devices, pharmacy data, insurer data, telehealth sessions and other personal health sensors, and keeping in mind that all these data are meant to be exchanged freely over the Internet, we are approaching a data tsunami of biblical proportions. And we are not done just yet. Once health care’s Big Data is released into the mainstream Internet, it will initiate secondary and tertiary waves of new data created by consumers addressing their newly found health care data on social media venues, specialty forums, blogs and commercial sites offering services for health data. Big Data is the fluid combination of the ever increasing real-time data streams created by everything from government to businesses to Facebook, Twitter, Geo-locators, mobile devices and connected sensors everywhere. Big Data is as much about size as it is about cross pollination of data from disparate sources.

A fascinating June 2011, McKinsey report predicts that Big Data is the “next frontier for innovation, competition, and productivity” and that Big Data will become equal to labor and capital in its importance to production. For U.S. health care, the report is predicting $300 billion per year in savings due to utilization of Big Data to drive the execution of strategies proposed by health care experts. In the area of clinical operations, the report lists projected savings from Comparative Effectiveness Research (CER) when tied to insurance coverage, Clinical Decision Support (CDS) savings derived from delegating work to lower paid resources and from reductions in adverse events, transparency for consumers in the form of quality reports for physicians and hospitals, home monitoring devices including pills that report back when they are ingested, and profiling patients for managed care interventions. Administrative savings are projected from automated systems to detect and reduce fraud and from shifting to outcomes based reimbursement for providers and, interestingly, for drug manufacturers through collective bargaining by insurers. Most savings listed under research and development opportunities from Big Data seem to accrue to pharmaceutical and device manufacturers. There is nothing to suggest that Big Data will somehow reduce unit prices of products or services.

To be honest, I don’t quite understand where the $300 billion in savings come from as there are no actual itemized numbers to support this prediction. In addition to stated reliance on individual studies and expert interviews, there are many structural assumptions regarding massive provider consolidation, proliferation of Accountable Care Organizations, technology adoption rates of 90% across the industry and data sharing amongst all stakeholders, at which point Big Data will come in and do its thing. The costs for generating, storing and analyzing Big Data which include emerging data storage technologies and analytical expertise are factored in, with the costs of national deployment of EHRs alone “estimated at around $20 billion a year, after initial deployment (estimated at up to $200 billion)”.

Most people, including doctors, will probably agree that pertinent data, big or small, can be transformed into pertinent information, and pertinent information is vital to good decision making. But is Big Data pertinent? Are all those petabytes of minute details about everything and everybody really useful, or are we just mixing a little wheat with a lot of chaff? There are various opinions on this, but the prevailing wisdom seems to be that the more data you have, the more likely you are to be able to extract something useful out of it. By observing patterns and correlations in this ocean of information you may discover answers to questions you wouldn’t have known to ask in the first place. There is much power in Big Data, but there is also danger. As big as Big Data may be, it does not guarantee that it is complete or accurate, which may lead to equally incomplete and inaccurate observations. Big Data is not available to all and is not created by all in equal amounts, which may lead to undue power for Big Data holders and misrepresentation of interests for those who do not generate enough Big Data. Collection and analysis of Big Data has obvious implications to privacy and human rights. But the biggest danger of all, in my opinion, is the forthcoming relaxations in the rigors of accepted scientific methods, and none seems bigger than the temptation to infer causality from correlation.

We’ve been there before. When humanity dwelt in caves and villages, correlation was enough to establish causality. We’ve come a long way since, but the global village we are creating today seems tempted to go back to observation as the main way of gaining understanding. Just like the historic villagers, we are now convinced that we can see everything there is to be seen; therefore the answers to all our questions must be found in the Big Data mirror we placed in front of us. All we have to do is stare at it long enough and the patterns will emerge. The sheer size and variety of Big Data will make it much easier to reject the null hypothesis and see patterns where none exist. On the other hand, if we keep staring at our digital selves in the eye for long enough, perhaps we will achieve the most coveted observation of all: a glimpse through the windows to our digitized soul.

Who Should Pay for EHRs?

2011-10-02T13:58:00.000-05:00

During the 2008 Presidential campaign, Candidate Obama promised an EHR for every American by 2014. The goal was to improve quality of care, reduce disparities and contain costs of health care. When the HITECH act became law in 2009, physicians found themselves under increased pressure to purchase an EHR. Many took action, went out and bought an EHR for their practice, and these are now well positioned to collect the financial incentives put forward by the HITECH act. Many more did not. EHRs are by and large a complex and expensive proposition and the HITECH incentives are not covering the average cost of purchasing and maintaining an EHR. In survey after survey, physicians consistently rank cost associated with EHRs as their top concern when considering transition from paper charts to electronic medical records. This is a bit disconcerting, since physicians have no problem buying other expensive tools and paying for human resources in their practices. How are EHRs any different?

Non physicians usually attribute this reluctance to computerize medical records to technophobia or a perverse need to keep patients uninformed in order to maintain power and perhaps even financial advantages. Physicians on the other hand, mostly argue that EHRs do not benefit them directly and therefore they should not be expected to use them, let alone pay for them. Since there is no evidence of physician technophobia in any other areas of medicine (or private life) and since there is no measurable benefit to doctors in keeping their patients in a subservient position, the question then becomes: who is benefiting from EHRs?

There are three primary stakeholders in health care: those who receive care, those who provide care and those who manage the financial aspects of health care, and no, we are not getting into the quintessential argument of whether there should be only two primary stakeholders. There are several secondary stakeholders as well: those who manufacture medical goods, those who provide ancillary services and those engaged in medical research.

Historically, an EHR has been defined as a software tool, used by health care providers to collect, analyze, display and exchange clinical information with others. The content collected in an EHR was exclusively generated by health care providers or by traditional ancillary service providers (e.g. labs, imaging, etc.). There is however a new type of ancillary service providers aiming to provide services directly to patients, mostly through mobile devices, who are clamoring for the right to become an accepted partner to the EHR clinical information exchange network. And of course patients, whether through these new ancillary service providers or directly, are also increasingly voicing a desire to be included in clinical information exchange. These developments are altering the classic definition of an EHR and changing the focus from tools to provide care to broad content management, which is more in line with Candidate Obama’s vision. In reality all these functions are still in their infancy, but the direction is fairly clear, and it is worth noting that unless all functions are optimally performed, there is not much benefit accruing to any stakeholder. Various constituencies may derive more value from one particular function rather than the others, but as long as that value exceeds what is made available by a paper system, someone should be willing to pay for it. Let’s examine our stakeholders, and their willingness to pay, from the bottom up.

Secondary Stakeholders – Here we find the drug and device manufacturers and the bewildering array of diagnostic facilities. Most of these companies are largely indifferent to what EHRs do and some stand to lose revenue when EHRs shine bright lights on spending patterns. They are not likely to consider paying anything for widespread EHR adoption. On the other hand, the mushrooming mobile health and personal health application providers, who base their entire existence on the availability and successful use of EHRs, show no willingness to share in the cost of computerizing medical records. Needless to say that medical research centers which have been habituated to mostly free access to data sources, may be willing to pay data aggregators, but would never consider participation in infrastructure investments.

Health Insurance Providers – The largest health insurance provider in this country is the Federal Government through the Centers for Medicare and Medicaid Services (CMS), and CMS is proposing to bear a rather hefty portion of the costs of EHR deployments. Obviously CMS is expecting to see great financial rewards from a fully functional EHR network. Whether CMS is placing onerous or misguided requirements on the technology is a completely different question and one has to keep in mind that CMS is primarily a payer and its primary concern must be proper stewardship of tax payer funds. To do that, CMS needs data, and lots of it. You don’t usually pay a mechanic to take a look at your car – you pay him to fix it. CMS is now paying health care providers to treat people and it would much rather pay them to fix people and keep them under warranty, and it would also prefer that this is done via a fixed price contract, instead of the current time & materials model. EHRs are the tools by which quality assurance is performed and deliverables are accounted for and measured.

What’s good for the goose should be good for the gander, and private insurers figured out that paying for EHRs may not be such a bad idea after all. I am not 100% certain, but I would suspect that financing EHRs for physicians in order to improve quality of care falls under the medical expenditures rubric and can be deducted from the federally imposed Medical Loss Ratios (MLR). Since private insurers have historically ran much tighter ships than CMS, I would expect that in return for their Stark exempt contribution to EHR expenses, private insurers will ask for at least as much data as CMS and probably a lot more.

Health Care Providers – These folks are as diverse as the patients they serve, but their interests in EHR are most closely correlated to their size, which ranges from the solo doc in a micro practice to integrated delivery networks serving millions of patients. For large providers who operate multiple and varied facilities of care, EHRs are a tool to effectively manage their business. They were always willing to pay for them and they are continuing to do so now, in spite of the constant rumbling about CMS regulations. At the other end of the spectrum, the small providers, mainly physicians in private practice, who are more financially strapped than ever, see no good reason to take on debt and pay for tools with no demonstrated ability to provide tangible returns. Keep in mind that using paper-based tools to manage a few hundred customers who purchase one of a handful of services between 9 and 5 four days a week, is not nearly as onerous as managing millions of customers purchasing thousands of different services around the clock all day every day. Nevertheless, even these small providers are starting to buy EHRs. As EHR software gets better, some manage to find efficiencies never before contemplated and others are just trying to keep up with the Joneses and survive. Reluctantly and grudgingly, with lots of hard feelings building up, they too are willing to pay.

Patients – All stated goals of EHR adoption ultimately benefit patients. Some may stand to benefit more than others, but in aggregate we will all benefit from improved quality, reduction in disparities and cost containment of medical services. Whether directly or indirectly, through taxation, premiums, wage reduction, increased prices of goods and plain old cash, patients pay for the entire enormity we call health care costs, which includes cost of actual care delivery, overhead and profit margins for all other stakeholders. EHR software is part of that overhead and so are the costs of analyzing, displaying and exchanging information collected by EHR software. When CMS and private insurers and even health care providers write checks for EHR software vendors, somewhere down the line this translates into a little bit less health care for each patient and/or a little more money needed to obtain care. So although we pay for all EHR expenses, we as patients, find ourselves in the perplexing situation where we are forced to lobby, argue, advocate and practically beg for access to the work product of EHR software. And that work product is our life story. It is the record of our birth, the narrative of our childhood successes and mishaps, a document of our education, sexual activity, fears, hopes, marriages, new children, career choices, residence, divorce, widowhood, disease, death and everything in between. In other words: Data. We are paying for this data to be collected, exchanged and analyzed. We are paying for people to decide if we should have a right to opt-in or opt-out of such activities. We are paying for media campaigns to convince us that what we are already paying for is worthwhile.

So here is one suggestion: instead of paying for EHRs indirectly, while allowing all stakeholders to complain about the expenses as if the fees came out of their own pockets, how about patients paying for EHRs directly? There is no difference in aggregate and we are not talking about a lot of money for each individual patient. A yearly fee of something between $5 and $10 per patient, per facility, should suffice. Call it EHR fee, or EHR subscription. Once we explicitly pay for it, we own it; not the software, not the hardware, but the Data itself. And this is how it should be.

Road Trip to Meaningful Use Land

2011-09-25T11:30:00.000-05:00

The voice on the phone seemed genuinely amused, “Let me see, the GPS can’t find our location, right?” Right. One U-turn by the burnt barn, a right after the Conoco station, another right at the end of the road, a left across the John Deere and two and a half hours from the city on highway W, brought me to a small and very white store front, housing a nail salon and a busy family physician practice. If I stretched out both arms, I could put one hand on the front desk, and place the other hand on the back of a waiting room chair. There were six chairs separated by small tables adorned with yellow silk flowers. A texting young man in jeans and baseball cap and a middle aged woman clad in floral attire and a big green purse, occupied two of those chairs. And then Bessie walked out the doctor’s office behind the usual and customary tennis ball footed aluminum walker which was almost as tall as her, and helped by the front desk lady made a slow trek to the one chair with arms on both sides. They were calling Joe to come pick her up. Joe was going to be there in ten, fifteen minutes, tops. It was 4 PM and they were running behind.

Looks can be deceiving though. This practice is an anomaly in the rural health continuum. There are computers in every room and not even a trace of paper charts. They’ve been on a top of the line Cadillac EMR since 2005, paying a small fortune every year for the privilege and for IT guys to support it. They kept up with all the upgrades and are on the latest and greatest certified version and would very much like to get the Meaningful Use incentive that will cover about three quarters of what they spent on EMR maintenance this year. The doctor would even like to try the patient portal. He thinks it could make him more efficient. They were all ready to go on October 1st, but then something happened. They started getting solicitation emails from their EHR vendor informing the doctor that there are several accessories that he must purchase in addition to his fully certified EHR, if he wants to qualify for Meaningful Use incentives, and of course, the Cadillac vendor has a special sale on accessories this month. Confusion and frustration were palpable around the huge, and completely out of place, formal pedestal dining table in the break room.

I’ve been to this movie before, and I never had any luck convincing this particular vendor that a certified complete EHR should allow the user to achieve Meaningful Use with no need for other bits and pieces that were not mentioned anywhere during the certification process. Unfortunately, those who certify EHRs and those who supervise the certifiers are turning a blind eye and a deaf ear to what is essentially a regulatory issue. In the break room the confusion and frustration were slowly changing to anger and the big plastic QT cups of pink lemonade that were brought in by someone didn’t help much. The conversation shifted to the various Meaningful Use measures and by now I wasn’t surprised to hear that they are doing rather well on most, from electronically prescribing everything to recording race and ethnicity and generating beautiful CCD clinical summaries. They weren’t sure how to give folks electronic copies of their medical records, but nobody ever asked for that and it’s highly unlikely that anyone will in the next three months. That should be good enough.

“Am I also good on immunizations? I don’t do many of those either… maybe a few HPV and some flu shots for elderly patients to save them a trip to the pharmacy. I shouldn’t have to report anything, right?” Eh… wrong, doc. Even if you only do one immunization in the next three months, you would have to test an immunization interface with the State registry, and your Cadillac EHR can’t generate the test file at this time although it is fully certified for Meaningful Use. I’ve been trying to get an answer from this vendor for months. I’ve asked CMS for a solution over a month and a half ago. I have written a blog post that got more page visits than anything I ever wrote before, and came up empty on all fronts. But the doctor seemed to be working his way to an innovative solution all by himself.

“So if I don’t give any shots after October 1st, I should be OK…. We have one bottle of HPV left anyway and Marcie needs her shot… I have a week to do that… They pay peanuts for shots, you know…. They’ll just have to go to the pharmacy…. It’s not that far…. I really don’t give many shots anyway… Yep. It should work… “. October is flu season, and I was wondering if Joe picked up Bessie by now and if the pharmacy is on their way home. I wanted to know if the pharmacy had a chair with arms for Bessie and if the pharmacy folks would also call Joe to pick her up after waiting in line for her flu shot. But instead, I just found myself mumbling that this wasn’t really the intent, but yeah, this should work.

A couple of months ago, I heard a story about a geriatrician who chose to stop giving courtesy flu shots to his patients because of Meaningful Use. I found it hard to believe then. Needless to say, I believe it now. I am certain this was not the intent at CMS and I am pretty sure this was not on the Meaningful Use roadmap at ONC. I am not in the habit of pleading and begging the powers to be to do the right thing, but I will make an exception this once. This unremarkable little practice in the middle of nowhere could have been the poster child for successful EHR adoption. Can somebody at HHS, CMS or ONC help these small practices stand up to the greedy whims of a powerful EHR vendor? And above all, can we do something to help Bessie keep her “I” in Health IT, please?

Disclaimer: In order to protect their privacy, the names of all people and locations mentioned in this post have been changed, as have certain physical characteristics, quotations and other descriptive details.

The Power of Empowerment

2011-09-18T13:27:00.000-05:00

Grant Wood, American Gothic (1930)

Housing is expensive if you want to live in a Tudor style mansion on a half-acre wooded lot. Housing is a lot cheaper if you choose to rent a two-bedroom apartment on the fourth floor of a square building with no elevator, 45 minutes away from your workplace. And it won’t kill you to rent. Food is also very expensive if you want a varied, fresh and gourmet diet, but food can be cheap, and it won’t kill you to cook your own food and stick to a diet of mashed potatoes and boiled cabbage, with an occasional bit of tripe. Health insurance is very expensive if you insist on having all your medical needs covered by an insurance policy. Health insurance can be a lot cheaper if you pay for most of your medical care yourself and if you only buy limited coverage for the eventuality of falling off your dressage horse, and cheaper still if you promise to drop dead shortly thereafter. Health care itself is very expensive if you insist on receiving medical care from highly trained professionals, using cutting edge technology in state of the art facilities. Health care can be a lot cheaper if you find a way to take care of your health without involving doctors and hospitals and their overpriced opinions, chemicals, machines and unnecessary procedures. It’s all about consumers empowered to freely make their own choices: mansion or rented apartment, steak or tripe, Cadillac or catastrophic health insurance, ICU or alcohol rub…..

The Consumer Empowerment terminology originated in the health insurance industry to mark the transition from having insurers pay for every cut, bruise and sniffle, to the more responsible way of paying for much of your health care directly out of your own pocket leaving the insurer responsible for rarely incurred catastrophic expenditures. The newly empowered consumers discovered that health insurance is now much more affordable, and perhaps even unnecessary, while health insurers discovered that magically, their profits are also improving, probably because empowered consumers seem to generate significantly less reimbursement claims, than the irresponsible and unempowered crowd served by public entitlements.

Although empowering consumers to pay for their own health care proved to be a stroke of genius, we have a long way to go before the overall cost of health care is contained. The problem here is that over the years Americans figured out that staying healthy doesn’t really pay off and quite the opposite is true, because once you get really sick there are all sorts of freebies made available to you, from amputations to chemotherapy to mastectomy to castration - a veritable smorgasbord to choose from, and the temptation is huge since the monetary value of these free goodies can add up to more than many people make in a lifetime of hard work. Not to mention the fatherly physician figures busy offering you helping after helping of a carefully selected array of the most expensive fare available. And then an innovative idea was put forward by selfless luminaries, and is catching on like brushfire after a long global warming induced drought. If health care insurers were able to cut costs and increase profit by empowering consumers to insure themselves, could health care providers achieve the same spectacular success by empowering consumers to care for themselves?

Empowering consumers to engage in their own health care may rank up there with cold fusion and perpetuum mobile in its transformational potential for humanity. Empowering millions of people to actively manage their medical care, by making their own medical decisions, breaking free of the old-fashioned paternalistic directives of financially conflicted physicians, and restoring the nineteenth century self-reliant approach to health care, will slash costs, improve quality and eliminate disparities in health and health care in one patient-centered fell swoop. And how do we accomplish such monumental task? We harness the unlimited power of the Internet. This is the Information age, and just like the Industrial age brought a car and a television set to every home, the Internet puts the entire world’s knowledge at the fingertips of all humanity with astounding effects already visible in the education attainment of our children. But the world’s knowledge is missing a vital piece of information pertinent to our goals in health care.

Enter Health Information Technology (HIT). HIT will pry loose the last piece of the puzzle – the secretive documentation amassed and jealously guarded by doctors in their offices. Information kept in detailed color coded charts and recorded in strange cult-like symbols that prevent anybody but doctors from understanding the contents. Once that information is made available to computers and the thousands of new high tech tools chomping at the bit to translate, analyze and recommend what you should buy to treat any ailment ever recorded, the Internet will bring this knowledge to every hamlet and fuel a renaissance of rugged Americanism where every man woman and child will be empowered to manage his or her own health care. The amount of money spent on health care will decrease sharply since the time people spend researching, diagnosing and treating themselves at home, and the cost of technology tools and over the counter remedies to facilitate these activities are not considered health care expenses. The quality of such care will be exponentially improved by harnessing the knowledge and insights of millions, instead of just one medical school graduate. And by definition, the Internet eliminates all disparities, as evidenced by the blossoming democracy in Egypt.

So much empowerment may seem a bit daunting to some who grew accustomed to getting advice from doctors. No need to worry though because this will be a gradual and gentle process. It’s not like you will have to perform an appendectomy on yourself come Monday morning, although it wouldn’t hurt to start practicing simple things like freezing warts at home and researching minor chest pain on Internet boards. When you finally keel over in pain, or are otherwise ready to confront a doctor, you must prepare yourself mentally to act as empowered as possible. While the civic minded insurers have been happy to empower people and let them spend their own money any way they saw fit, doctors find it much harder to relinquish control of their patients. You need to come in with all your symptoms researched, a tentative diagnosis formulated and most important, a preferred course of treatment that fits your cultural values and preferences. You need to resist your doctor’s efforts to tempt you into partaking in the smorgasbord of free tests and procedures, some of which will be harmful to you and others will be very unpleasant for your friendly insurer. If you concur with your doctor’s opinion and have some tests done, make sure you understand WBCs and RBCs, units and normal ranges for the lab you are going to use after shopping around for a good price, and be sure to validate whether you need a differential count or not. The Internet is your friend and all this information is available online. But whatever you do, don’t leave your doctor’s office without an electronic copy of your medical records in a computable format, because any day now, there will be a free app for all these decisions and iWatson will empower you to care for yourself and your loved ones in ways that the log-cabin pioneers couldn’t even dream about. Better, faster and infinitely cheaper.

CMS Owes an Apology to Meaningful Users

2011-08-23T16:43:00.000-05:00

According to the July 2011 data from CMS there are over 75,000 clinicians currently registered for the various Medicare and Medicaid Meaningful Use incentive programs. A tiny fraction of these, 2246 to be exact, has successfully attested to meeting all Meaningful Use criteria (or claimed allowed exclusions), and about half have gotten the much coveted incentive checks. Considering that these figures include Nurse Practitioners, Dentists and Optometrists, it seems that the physicians that expressed interest in the incentives by registering with CMS are the same 6.9% that were identified by CDC in 2010 as using fully functional EHRs back in 2009. Even if we assume that the second half of 2011 will bring a surge in attestations to meaningful use of certified EHRs, it is still unlikely that a majority of those registered will go through attestation.

There are three broad reasons for these low numbers. First, there are those working their way through the 90 days attestation period as we speak, or are planning to start any day now. These folks have their ducks in a row and will attest in 2011. Second, there is a group that went ahead and registered with CMS “just in case”, but made no commitment to investing the energy and time needed to fulfill Meaningful Use requirements. These physicians are still debating whether they should upgrade their EHRs to a certified version, or if they already have a certified EHR, whether they are ready to begin documenting all the additional information in the specified formats as required for attestation. With less than 6 weeks left before the absolute last day for starting to measure, there is practically no chance that this group will be able to attest this year, and many registered with a clear intent to postpone Meaningful Use to 2012 anyway. Third, there is a significant number of doctors whose plans and efforts are being frustrated by shortcomings of EHRs and EHR vendors. This last group warrants a closer look.

Judging by press releases and earning reports from publicly traded EHR vendor companies, business is booming and EHRs are selling like hot cakes. The flip side, of course, is that waiting times for software installation are steadily increasing for both new purchases and upgrades. Since ONC certification bodies have no requirements stating that the certified software should be in actual use by customers, many vendors were able to certify EHR versions that were not ready for general deployment. Some vendors deemed it necessary to charge significant fees for functionality required for Meaningful Use in addition to the ongoing maintenance fees which should have entitled their existing customers to a free upgrade to the certified version. Adding it all up results in many unhappy customers having to wait in long lines for something that should have been forthcoming, and having to spend large sums of money on something that should have been free. And when they finally reach the front of the line and pony up the various extortion fees, they may still end up right back where they started.

Over a year ago, on this blog, I posed a very simple question: “Can you buy an ONC Certified EHR, or a package of EHR modules, and discover to your chagrin that no matter how hard you try, Meaningful Use is not within reach?” After a close look at the certification criteria for EHR software, my conclusion was that “Physicians need to understand, and ONC needs to clarify, that although required by CMS, ONC EHR certification does not guarantee availability of all EHR features and functionalities required to achieve Meaningful Use.” Of course physicians did not understand and ONC did not clarify and here we are today fully engaged in damage control. The problems range from rampant software defects to impossible workflows to plain missing functionality. How is that possible?

If you ever dabbled in software development, you should know that successfully testing a few predetermined isolated function points in a large software package is never an indication that the software works as designed. To use our beloved car analogy, starting the car once, turning the lights on once and activating the wipers once provides no solid indication that the car is not going to explode after two minutes on the highway, let alone that both wipers and lights will keep on working as you proceed out of the dealer parking lot. Now imagine that the car seller is allowed to performs all these tests while you are standing aside, observing the final result only. So a hotwire instead of an ignition key, a string attached to the wrist to pull the wipers back and forth, and a bunch of little flashlights instead of brake lights are all possible. That’s the essence of Meaningful Use EHR certification testing. Sometimes you get lucky and sometimes the thing you just bought smokes, and barely limps along sputtering motor oil and antifreeze.

But nothing is more misguided and inappropriately tested as the various requirements for interoperability. There are several Meaningful Use measures requiring that the EHR has the capability of exchanging information with other facilities, and that the user performs just one test of that capability to qualify for incentives, and the test does not even have to be successful. Sounds easy when you sit in a conference room overlooking blossoming cherry trees on the Potomac. Returning to cars, imagine that the requirement is that the vehicle is able to tow another car, or a U-Haul little trailer, or a boat. During certification, the vehicle presents with a lovely towing package installed; the tester attaches a cardboard car model to it and the entire assembly is shown to be able to advance one inch from where it was originally located. Hence, the vehicle is now certified for towing cars. The first thing you discover after you purchase the certified vehicle is that the various towing packages don’t come standard with the car. You will have to pay for each one and pay to have it installed. To add insult to injury, the towing packages have only been tested with cardboard models and there is much work to be done before they can be tested with real boats, cars and trailers. And there are several hundred customers in line ahead of you. Perhaps you should call again in a few months, or better yet don’t call us; we’ll call you.

To qualify for Meaningful Use incentives a physician must perform at least one test of submitting either public health data or immunizations data to a public agency. Exclusions apply to those who do not administer immunizations and to those who practice in a State where there is no public agency capable of accepting such data. There are less than a dozen agencies where one could submit public health data, but many more immunizations registries up and running. A typical very large EHR vendor will have operational interfaces to less than a handful of immunization registries that are readily available for purchase, usually in States where health information exchange is very advanced. Everywhere else money can’t buy you an immunization interface. It can buy you a place in line, if the vendor is working on an interface with your State registry. Otherwise a rain check is the most you should expect.

There is no way physicians could have anticipated this problem when they purchased a fully Certified EHR. There is nothing physicians can do now, or could have done earlier, to address this problem. And there is no way for EHR vendors to create over 50 working interfaces to State registries and deploy thousands of those interfaces to their customers before the clock runs out on 2011 reporting periods. By ignoring the reality on the ground, CMS erred in its requirement and ONC erred in its certification process. The only thing left to do now is for CMS to officially allow exclusion of public health measures across the board. An apology wouldn’t hurt either….

From EHR to HIE and Back

2011-08-08T12:12:00.000-05:00

According to the latest count, there are 255 Health Information Exchange (HIE) organizations across the country, which amounts to an average of 5 in each State. If you are a practicing physician and have an EHR, chances are someone already knocked on your door offering to connect your practice to the local HIE for a small fee. If you don’t have an EHR, you may have had offers to access an HIE web portal, or maybe an HIE supplied EHR Lite, allowing you to at the very least view clinical data from other sources. Perhaps for free. If you are the proud owner of one of the full-featured EHRs, you may wonder what an HIE can do for you that your EHR is not already doing, and whether that service is worth your hard earned money.

In theory, a top-shelf EHR should be able to connect your practice to multiple facilities and allow you to exchange information to the best of all participants’ abilities. Granted most EHRs are still working on some of the connections, particularly to local facilities, but all in all, an EHR should be able to eventually provide for all your connectivity needs as shown in Figure 1. Note that for some types of connections, your EHR vendor can use a clearinghouse or portal approach to simplify and reduce costs of connectivity. For example, you don’t need a separate interface for each pharmacy – you use Surescripts as the clearinghouse and let them worry about it. You also don’t need an individual connection to each patient’s home – you communicate with all of them through one portal. With the exception of Surescripts pharmacy connectivity and a small number of reference labs, each connection, or interface, is costing you a pretty penny, and the more local the connection, the longer it takes to build.

Enter the local HIE. The value proposition of a regional exchange is in connecting you to local hospitals, imaging centers, State agencies and community resources. Figure 2 shows a typical HIE arrangement. If you compare this to Figure 1, it becomes apparent that your EHR vendor has a much easier job now. Instead of building an interface to each hospital, the vendor needs just one interface to the HIE and presto, you are connected to all hospitals. Yes, this is an outlandish oversimplification of affairs, since most players have no ability to connect to HIEs and since each message type requires its own separate interface (or special code to sort messages out). If your EHR vendor has a critical mass of customers in your area, all needing to connect to the same regional facilities, a connection to the HIE should create significant savings for the EHR vendor, and hopefully some of those savings will be passed down to you. The HIE will in turn try to get a portion of that money from you to cover their costs of building and maintaining interfaces. If there is more than one HIE in your referral region, your EHR vendor may need to repeat the effort for each HIE. This will increase the complexity and costs for all involved.

Some HIEs are trying to do more. Although EHR vendors are increasingly integrating abilities to exchange information between physicians through the Direct Project protocol, HIEs are attempting to do the same thing. Depending on your EHR vendor, the HIE may be a few steps ahead and will offer you that functionality. Of course, it will not be integrated in your EHR workflow, but it may still be worthwhile. Since most HIEs retain data exchanged through them (or have the ability to retrieve it from the source), they are also considering offering patients access to their data. If your EHR vendor does not offer a Patient Portal or charges a lot for one, this may be a very tempting proposition. Figure 3 illustrates this more comprehensive setup, which also includes connectivity to reference labs, as this is a simple thing to do and several HIEs are doing just that. The HIE menu of services in Figure 3 will cost you substantial subscription fees, and rarely some transactional fees, on top of what you are paying for your EHR.

If you don’t have an EHR, some HIEs will offer you a one stop shop, which can include a lighter version of an EHR (geared to Meaningful Use), which includes electronic prescribing. This may be a cumbersome solution if you still need to maintain a paper chart, and perhaps this is why the top HIE vendors offer EHRs that are fully functional and which only need to be connected to your Practice Management System (PMS), as shown in Figure 4. In this scenario, you would have to pay the HIE a hefty price, but you won’t have to pay extra for another EHR. Finally, there is at least one HIE out there, and I am certain more will follow, which can accommodate your billing needs as well.

Having come full circle, Figure 5 illustrates the complete transformation of the HIE into a complete EHR and PMS. The difference between Figure 1 and Figure 5 is not just terminology. The system in Figure 1 stores data either in individual physician databases or in a national database of all EHR customers for an Internet based EHR. In Figure 5, you are accessing an EHR that contains the data of other physicians, hospitals and care agencies in your area. This is a much more powerful configuration and better suited to care coordination and care management. This is pretty much how large health care systems are set up and in most cases the HIE is run by their enterprise EHR vendor. In fact, just like HIE vendors are building EHRs, most large EHR vendors either have, or are quickly assembling, formal HIE capabilities (master patient index, good interface engine, robust database structures).

So here is a wild prediction: it may take a while, but eventually small EHR vendors will be replaced by strong HIEs, and weak, failing or nonexistent HIEs will be displaced by large EHR vendors who had the ability and wisdom to become HIEs, and there will be no distinction between the two types of software vendors. Right now the 255 HIE organizations across the country are struggling to find a way to become sustainable businesses, and most EHR vendors, while posting record profits, are struggling to provide much needed interoperability. A marriage of necessity is inevitable. What should we name the baby?

Bending the Curve with EHRs

2011-07-24T21:28:00.000-05:00

The post you are about to read may not be suitable for wonks. Its claims are not fact checked. Its author is not a researcher. And its opinions are not fully thought through. Reader discretion is advised.*

EHR adoption rates are picking up significantly, exceeding the most optimistic expectations. Instead of an EHR for every American by 2014, as the President commanded, we will have dozens of EHRs for each American long before that. And in health care, more is always better, not to mention the freedom of choice that comes with having a different EHR in each care setting. Not surprisingly, we are seeing a decrease in health care expenditures taking place in parallel with the uptick in EHR adoption. Following best practices in health care economics research, when two phenomena develop in parallel, the learned assumption is that there is a causality connection between the two. Deciding which phenomenon is the cause and which is the effect is discretionary and commonly based on undisclosed agendas.

It is therefore postulated here that health care expenditures are inversely proportional to EHR usage rates. The following is a rigorous analysis of the mechanisms by which EHRs are reducing health care costs, intended to inform policy makers as customary in most health care related studies, which cannot be completed, or published, without a salient recommendation of interest to policy makers.

Productivity Optimization – Numerous carefully estimated anecdotal studies consistently show that introduction of an EHR in ambulatory practice can reduce provider productivity by 50% or more. This directly translates into 50% (or more) savings in health care expenditures for office visits. Unfortunately, the same studies also show that in most cases this reduction in office visits is transient, with most providers regaining ability to charge for as much as 80% of their pre-EHR visit volume within six months to a year. Still, 20% long term savings is significant and could probably be optimized further by introducing more speed tempering features into certified EHRs. Equally rigorous studies show preliminary evidence that the savings realized from introducing fully functioning EHRs in Emergency Departments far exceed those in the ambulatory sector. Unlike other Socialist countries that were compelled to nationalize the entire health care system just so they can reduce productivity and discourage utilization by creating long waiting lines, Yankee ingenuity is producing better results at lower costs.

Banishment of THE Pen – The Physician Pen has been long known for being the most financially devastating instrument ever invented. In spite of pharmaceutical reps efforts to the contrary, EHRs are successfully removing all pens from medical practice, including but not limited to, the Physician Pen. Where physicians used to carry several handsome pens in that little pocket right under their embroidered name and title, they now carry an EHR contained in a device that may or may not fit in a less accessible pocket and either way requires both hands, ample light and an adequate supply of battery power to order the simplest thing. The better EHRs also provide various speed bumps on the road to ordering by popping up multiple warnings and good financial advice equidistantly placed at 10 to 15 milliseconds intervals. Data from the very similar retail industry shows that impulse buying is greatly increased by simplifying the process, such as the one-click checkout at Amazon. The reverse logic must also be true, so increasing complexity should reduce impulse ordering in medicine. Judging by Amazon’s successful strategy, the savings in health care are expected to be spectacular.

Customer Intimidation – As EHRs become better at measuring the abysmal state of our health care non-system, and expose the horrors and frequency of medical errors by either careless omission or profit-driven commission, it is estimated that health conscious consumers will increasingly avoid dangerous encounters with the medical complex, thus further reducing utilization and cutting costs. Strategic publicity campaigns advertising security and privacy breaches in other computerized industries, and in health care if any are found, should eliminate another segment of customers. However, the largest cost savings are projected to come from customers refraining from seeking care for, or even mentioning, potentially embarrassing health problems for fear of public exposure through interconnected EHRs.

Accelerated Attrition – EHRs are very powerful tools. So powerful that the prospect of having to purchase and use an EHR is more than enough to prompt older physicians, particularly those in private practice, to consider retirement or transition to other occupations. The evidence shows that there is direct anecdotal correlation between negative reaction to introduction of EHRs and acceptance of cost-saving team approaches to provision of medical care. The semi-natural attrition of experienced and highly compensated physicians who insist on treating, and charging for, every sore throat and every knee scrape, in spite of mounting evidence that lower paid resources can refer those to appropriate specialists with equal outcomes, should in the course of time increase the amount of savings directly attributable to the prevalence of EHRs.

Free Labor Procurement – EHRs are particularly adept at encouraging and showcasing the historical selflessness and ethical conduct of medical doctors, by providing multiple means for doctors to contribute to the wellbeing of their patients practically free of charge, at all hours of day and night. From the ubiquitous email to the occasional webcam session to the continuous evaluation of uploaded self-quantification vital data from patients empowered to have their health expertly monitored, physicians using EHRs can provide this simple courtesy service to their customers from the office, the home, the yacht or the golf course. These proactive preventative measures should result in extensive reductions in disease burden. Constantly connected physicians, armed with the latest monitoring tools, could detect strokes, heart attacks and maybe even cancer years before actual manifestation of symptoms. And at no cost to society.

The implications for policy makers are pretty straightforward. EHR adoption should continue to be encouraged at all costs. EHRs must evolve to seamlessly and continuously connect to all consumer monitoring devices, which implies a preference for cloud based technologies, and a security breach here and there is not necessarily an impediment to success. EHRs should continue to increase the levels of automated decision support, improve analytics and increase frequency and scope of various alerts. Basically, keep up the good work. We’re right on target.

*Disclaimer partialy plagiarized from the UK version of The Daily Show

Voices of Primary Care: What is a Medical Home?

2011-07-18T15:36:00.000-05:00

Guest post by ANONYMOUS, MD

I have heard of the "Nursing Home" and I am not sure most of us aspire to getting there…

We all carry an image of our own HOMES: it is often idealized in phrases such as “Home-sweet-home” or “There is no place like home” or "Home is where the hearth is”. We even talk about being “HomeSick”.

Do any of these even remotely resonate with “THE Medical Home”?

Now granted, a “homey” doctor’s office may be a worthy goal. Making our patients feel “at home” with proper hospitality and kindness, a relaxing environment, maybe even the smell of baking are all likely to be improvements over our current obsession with best business practices, efficiency and evidence. To the extent that these characteristics become the defining feature of “The Medical Home” we might be on to something.

But "The Medical Home" instead seems to suggest that the doctor’s office is the place where health resides.

Isn’t the intention of the medical home movement really an effort to reassert the importance of solid, comprehensive primary care built on the ongoing relationship between the patient and his or her primary care physician? If so, why not say so? What would we call that? How about good Primary Care?

The New York Times Foray into EHR Usability

2011-07-17T16:19:00.000-05:00

So the New York Times is throwing its hat into the Electronic Health Records (EHR) usability debate, mixing up terminology to reach a predetermined conclusion, as is customary in modern media coverage. The story starts with a blazing inferno in 1904 Baltimore and ends with a categorical statement from a highly credentialed source naming usability the “single greatest impediment to physician acceptance”. In between this skillful framing of the subject, there are the obligatory dissenting arguments from two EHR vendors and a bewildering array of expert arguments confusing usability with safety and interoperability standards, complete with the usual comparison of health care to aviation.

The 1904 Baltimore fire, for example, where fire trucks from other cities were prevented from assisting the locals because their hoses could not connect to Baltimore’s water hydrants, makes an excellent argument for the need of interoperability standards in electronic medical records. It contributes nothing to support usability standards, since the problem was not traced to the color and softness, or ease of operation, of the non-Baltimore fire hoses. Nevertheless, most readers have no desire to perish in a blazing inferno induced by EHRs, so a receptive mindset is established upfront, whether it has anything to do with what follows, or not. The little jab at the vendors of fire hoses opposing standardization because they “did not want competition”, and so they “undermined the usefulness of, and investment in, the technology of the day”, is also helpful in framing the desired perception of what’s to follow.

The next nugget designed to create fear, uncertainty and doubt (FUD) is a statement from a computer scientist which obviously deserved its own two line paragraph: “This is an issue that potentially affects the health and safety of every American”. Yes, “changing the size, color and placement of graphic icons on a screen”, cited as an example of the deterministic and measurable science of usability, will definitely do wonders for the health and safety of every American. It will also contribute to gainful employment of many newly minted usability professionals, which is a good thing in these difficult economic times, and it shouldn’t raise the cost of producing EHRs by more than rich doctors can bear. And if government hires its own experts and then dictates where all the little icons should be placed, and what color they should be, maybe EHR vendors can actually cut costs by firing their own experts. After all, there is usually only one way to do things right, and when Bill Joy said that “innovation happens elsewhere”, he probably meant that it happens in federal government agencies and their contractors.

Let’s not forget that according to quoted “specialists”, usability standards worked well for “jet plane cockpits, air traffic control towers and nuclear power plant controls”, ergo “[s]ome of that expertise, …. , can surely be applied to doctors’ offices and hospitals”. Surely. Most Americans have little understanding of those complex industries and are both in awe of their potential disasters, and grateful for not being burned to a crisp by nuclear explosions and great balls of jet fuel fires on a daily basis. If all it takes is placing colorful little icons in certain spots on a computer screen, then by all means, let’s do it. Never mind the advances in avionics, composite materials, computer aided design and testing, and nuclear technology, the improved safety records must be all due to the novel placement of little icons. This is supported by a similar development in health care where marble floors and the presence of at least one atrium has significantly improved the quality of medical care as evidenced by a recent study that shows that critical access hospitals, that lack marble and atriums, provide inferior care. Probably because stepping on smooth Italian marble shaded by exotic banana trees, is much more satisfying for users, than walking on discolored linoleum with peeling edges flanked by cheap plastic ferns.

As to the categorical closing statement naming usability of EHRs as the “single greatest impediment to physician acceptance”, whatever acceptance means, I would suggest a quick literature review of physician surveys that constantly place the price of EHRs and the lack of calculable return on investment as the #1 impediment to technology adoption. Perhaps the experts interviewed or quoted in the New York Times are confusing usability with usefulness.

The government has a clear role in defining interoperability standards for EHRs and the FDA has a duty to ensure reasonable safety of software and devices used in medical care, but the placement and color of little icons has nothing to do with either and with all due respect to user experience experts, clinical safety should be left to those expert in that field. Forcing all EHR vendors to hire interior designers and to order Italian marble and live banana trees, because they seem reassuring, satisfying or just plain cool, will not increase the usefulness of EHRs. It will however drastically increase EHR prices, which are already on the rise as an unintended consequence of Meaningful Use. Once EHRs become truly useful to physicians, there will be no need to be concerned with the dubious “acceptance” factor.

Invitation for Practicing Primary Care Physicians

2011-07-16T17:19:00.000-05:00

Health care is currently experiencing tremendous turbulence. The old ways of doing things are about to give way to new ideas and new models, or perhaps just refurbished old models, and at the heart of it all is primary care. The old hope of care management has been rebranded to advocacy for care coordination, because the term coordination sounds more benign and better aligned with the increasingly vocal patient engagement movement. After all, empowered patients do not wish to be managed, but they do expect that someone will coordinate their informed decisions and preferred courses of treatment. Unlike management, which implies a paternalistic approach to patient care, coordination implies efficiency with no loss of freedom of choice. From a public relations perspective, this is a brilliant change of messaging content.

Care coordination is also the main ingredient in patient-centered care, by far the most overused buzz word of health care transformation. Other than individualized coordination, patient-centered care should be delivered by care teams, guided by population based medical evidence and measured by aggregated, process and outcome, population based statistics. The main vehicle to facilitate such change is the Patient Centered Medical Home construct as defined by the numerous NCQA accreditation requirements. Since Medical Homes require care teams of various capabilities, engaging in the coordinated sport of health care delivery, it is recommended that primary care physicians operate in large systems and facilities, where qualified team members are readily available, and a steady paycheck is guaranteed for the team doctor.

Medical Homes require state of the art computer technology to facilitate coordination, evidence based protocol enforcement and statistically meaningful measurement of compliance and outcomes. Health care computer technology adoption is being encouraged by the federal government through the well-publicized Meaningful Use series of incentives and penalties. The equally well-publicized complexity and prohibitive costs of health care computerization imply that large system are much better suited for widespread deployment, thus freeing their physicians, who have already been relieved of financial uncertainty, to better concentrate on the labor of managing the provision of health care. The quintessential problem of physicians being too busy seeing patients and having no time to deal with administrative, financial and technology demands, is thus resolved.

If you are reading this, and are experiencing an uncontrollable urge to through the computer against the wall right about now, you obviously are able to find a few minutes in your busy schedule to surf the web, read blogs, forums and maybe browse the news pages. Perhaps once in a while you even post a short comment here and there, most likely anonymous. Perhaps you are a social media maven, tending to your own blog or facebook/twitter presence. Most likely this is not the case because maintaining a web presence is pretty hard work. One thing is certain though; you most definitely have at least one opinion regarding the turmoil of our health care system and the particular circumstances surrounding your chosen profession.

So if you feel the need to express your thoughts, once a day, once a month, once a year, once in a blue moon, or when it can be contained no more, I would like to offer you a safe and easy way to do just that. Although this page’s title implies technology, you can see that much of the content is actually geared to the plight of primary care in small, private settings, which has been my personal passion for many years. This little blog has been my home for well over a year now, and I would like to invite you to make it your home too.

Anytime you feel the need to write, on any health care related subject, just type it up (or use your dictation tool) and email it to me. It could be a long essay or a short note, and it does not have to be Shakespearean prose either. All materials will be promptly posted, unedited, uncut, with no judgment and no commentary, anonymously if you so desire. You will not reach millions of readers, but you will reach quite a few influential folks active in the health care field, and I will do my best to spread the word. This is an open invitation, with no strings attached, no expiration date, no exclusions, no rules, no guidelines, no protocols, and with a simple goal of providing an outlet for the voice of practicing primary care physicians who have been largely silent and “too busy seeing patients” for way too long. I view it as a service.

Feel free to forward and share with others. The first such post from an anonymous MD, who was the inspiration for this service, will appear here on Monday, July 18.

So Many EHRs and So Expensive….

2011-07-14T14:12:00.001-05:00

There are currently 386 software packages certified by an ONC approved certification body as ambulatory Complete EHRs, which means that the software should allow the user to fulfill all Meaningful Use requirements and possibly qualify the proud owner for all sorts of CMS incentives. There are 204 more software packages which are certified as ambulatory EHR Modules, and a proper combination of these packages could result in a Complete product, which if used appropriately could lead to the same fortuitous results.

There are 423 distinct manufacturers of ambulatory EHRs and EHR modules on the federal list. Most are software vendors, or wannabe software vendors, but a fair amount are facilities that developed an EHR for in-house use and had it certified. These are not really available for purchase. A very large number of listed vendors offer niche products for distinct specialties, such as optometry, oncology, behavioral health, etc. All that said, there is still an inordinate number of EHR “choices”, or so the story goes. By comparison, since we all love car analogies, there are 1,310 individual trims currently sold in the U.S., and around 50 car manufacturers overall. If you ask an average citizen on the street to name their top 10 cars, chances are that you will get a Honda Accord, Toyota Camry, a Caddie, maybe a Ford truck, a Beemer, a Porsche and perhaps even a Beetle. You are not likely to hear anything about a Tesla or a Coda and rarely will anybody mention a Scion. Automotive modules are not widely sold for home assembly, so there is no parallel lesson there. One way or another, we manage to find our way when it comes to automobiles.

When it comes to EHRs, if you ask an average health care worker, including HIT experts, to create a top 10 EHR list, most will have trouble coming up with more than three or four, but generally speaking, you will end up with Allscripts, eClinicalWorks, Next Gen, maybe Epic, GE or Cerner, and sometimes Amazing Charts or e-MDs. Rarely, you may get the name of a newer or a more regional product and perhaps a specialty specific EHR as well. This doesn’t sound too daunting now, does it? At least no more daunting than shopping for a car. What about the Teslas, Codas, Fiskers or even Scions and Kias of the EHR world? Aren’t we missing out by not exploring every single innovator on that long list of hundreds of complete products and the collection of modular bits and pieces? Perhaps the next great thing, the diamond in the ruff, is already on the list….. Perhaps it will get added next week, or next month, or next year….

Perhaps, but I wouldn’t lose any sleep over it. Innovation is about more than using a web browser or an iPad to deliver the same old content, and those olden EHRs are teeming with innovation. The three committed partners for the cutting edge Surescripts-AAFP Physicians Direct collaborative platform are SOAPware, Amazing Charts and e-MDs, all on the “legacy” list. Cerner is positioning itself to replace Google Health in a very innovative consumer facing move. eClinicalWorks has a peer-to-peer communication system that has not been duplicated yet. Through the grapevine I hear that GE and e-MDs are both working feverishly on the next generation of EHRs. And the list goes on. In this day and age of massive regulatory demands, all EHR vendors must devote quite a bit of effort to compliance. Those with capacity for additional innovation are usually the well-established and well-capitalized companies, which are the same companies that amassed incredible expertise in health IT over the years. Speaking of the innovative Direct Project, it may be instructive for some to do a little homework on its originators (hint: it wasn’t two guys in a garage).

How about the widely advertised astronomic costs of these “legacy” EHRs? Why pay so much money for software when the new models are so much cheaper? Stories about doctors spending $250,000 in just the first year are not uncommon. Not sure what those doctors purchased, but whatever it was, they shouldn’t have bought it. eClinicalWorks, one of the top selling “old” EHRs, can be purchased for $250 per provider/per month. Can it get cheaper than that? Sure. Amazing Charts, another golden oldie, sells for less than $85 per provider/per month. The various ad-supported freebies notwithstanding, the next best thing would be for someone to pay the customer to use the software. Are there any new and bare bones EHRs on the federal list that sell for less? None that I know of. But maybe bare bones products are actually better, or simpler to use. Although “lees is more” is the new battle cry of health care, a little bit of complexity goes a long way. Guess who are the only recipients of the Surescripts White Coat Quality awards in ePrescribing (denoting commitment and achievements in the areas of safety and accuracy)? Two old eRx companies and two old EHRs – e-MDs and NextGen.

What about service? With the current flurry of EHR shoppers, largely driven by Meaningful Use incentives, those household name EHRs are flooded with new customers. The lines are long and customer service is spread thin. Should you go across the street and be treated like a king, since you probably are the only customer of one of those new bare bones vendors? If the lines are long at the Toyota dealer, should you go across town to the Kia dealer and pay the same amount of money that would get you a Camry for a minuscule Kia Soul? It is also worth remembering that since the ultimate goal is exchange of information, when hospitals and various exchanges start building interfaces in earnest, the waiting lines will be reversed. Those using EHRs with the largest market presence will be first in the interoperability line.

Last, but not least, what if tomorrow the perfect EHR is invented and you are stuck with the product you bought today? Here is where the car analogy stops working. If they invent a car that runs on water from the garden hose, chances are that you can trade your Toyota Camry in, lose a lot of value, but rather easily drive out in your brand new bubbly water car. Switching EHRs is hard. It’s not impossible, but it is expensive and fraught with peril. Since I can assure you that none of the EHRs currently on the federal list are the holy grail of EHRs, and there is none of those on the horizon either, you will take this risk on, no matter what you buy today. You need to decide if your odds are better with an established, “old” company that may charge you quite a bit of money to migrate data out of their EHR, or if you prefer to deal with a company that just vanishes into thin air one evening and the only thing left is a disconnected phone and perhaps a colorful website loaded with flash banners telling you how much money you can get in incentives from Uncle Sam. Of course, you don’t have to buy anything. You can just stand on your front porch, holding your garden hose, waiting for an impending miracle. And miracles do happen…..

Full Disclosure: I have no financial interest in the products mentioned in this article, or any other EHR software.

Process Centered Medical Home

2011-07-02T14:56:00.000-05:00

A new study on Patient Centered Medical Homes has been published in Health Affairs and we have a new, but predictable, indictment against small independent primary care practice. The study authored by Rittenhouse, Casalino, Shortell et all, is descriptively titled “Small And Medium-Size Physician Practices Use Few Patient-Centered Medical Home Processes", and follows an earlier 2008 study that surveyed large medical groups. The study is surveying practices with 1 to 19 physicians, and in a nutshell, small practices, particularly those owned by physicians, are less likely to have medical home processes incorporated in their workflows. On average, the bigger the practice, the more likely it is that medical home processes are used, and the likelihood increases if the practice is owned by a hospital or an HMO. Hardly surprising, but the enlightenment is, as usual, in the details.

The patient centered medical home model is based on the seven joint principles stated by the various primary care associations as follows: personal physician, whole person orientation, physician led care team, coordinated care, quality and safety focus, increased access and payment reform. Both studies quoted above were restricted to measurement of processes indicative of only four out of the seven principles. Personal physician for each patient and whole person orientation were left out, and so was the payment reform principle, although some measures of external incentives in support of medical home processes were considered.

The existence of physician led care teams was ascertained based on the existence of “a group of physicians and other staff who meet with each other regularly to discuss the care of a defined group of patients and who share responsibility for their care”. Not sure why, but solo and 2 doc practices were not even asked this particular question.

Care coordination was measured through the use of electronic medical records, electronic prescribing, and electronic access to notes from specialists, hospitals and emergency departments, use of registries and existence of nurse care managers. Small practices scored badly on all except electronic receipt of external documentation. It seems that even without EHRs, they somehow manage to get the information needed for proper transitions of care.

Quality and safety were measured by several process improvement methodology questions and typical quality of care measures. Small practices showed measly participation in quality improvement collaboratives and had almost no “Rapid-cycle quality improvement strategy” (no idea what that is and I bet few if any survey respondents did either). Solo and two doc practices were not very good at collecting data from their EHR and scored poorly on use of clinical decision support. However, they held their own when it came to providing physicians with feedback and provided patient education as well as the big boys. They were also par for the course on sending patient reminders. The major “surprise”, noted by the study authors, was how much better those tiny practices were at incorporating patient feedback and generally listening to patients. The 1 -2 docs scores in this sole patient-centered category surveyed, were twice as large as the largest practices, across the board, hands down, no contest.

Finally increased access was measured by availability of group visits and email exchange with patients. Not sure why group visits was chosen instead of same-day access and afterhours access, and as you would expect solo practices don’t do too many group visits. But, lo and behold, they are excellent at emailing patients - a full order of magnitude better than large practices.

By aggregating all survey responses, the study concludes that only 21.7% of medical home processes are used amongst practices of 1 to 19 physicians, with the 1-2 doctors segment lagging at only 18.6%, the 13 -19 group exhibiting a respectable 32.7% and the rest somewhere in between. Since the results are presented in a slightly different manner, it is a bit hard to compare these small to medium practices to the large medical groups surveyed in 2008, but it seems that there too, the largest of practices were more likely to implement more medical home processes with the possible exception of listening to patients, which came in lower than anything in the new survey. The authors suggest that one could look at these results “as a glass one-fifth full, or four-fifths empty”, depending on one’s level of optimism. I would like to suggest a different perspective on this particular glass.

The biggest concern regarding both studies must be the omission of the first and most important principles of the patient-centered medical home: the personal physician for each patient and the whole person orientation. While I do understand the difficulty in measuring the latter, it is pretty straightforward to survey and measure the former. The only two measures in this survey that are indicative of how patients are viewed and treated (minding patient feedback and email with patients) show clear advantages to the independent solo and two physicians practice. I would add that by definition, a solo practice should score around 100% on the personal physician rubric. And as the authors noted in their 2008 article “although infrastructure components are important to ensuring that care is coordinated, integrated, safe, of high quality, and accessible, at the heart of the PCMH is the personal physician and a team of professionals providing first-contact, continuous, and comprehensive care. This focus on primary care adds a qualitatively different dimension to the model. From the patient’s perspective, a medical home is not simply a combination of disease registries, reminder systems, and performance measurement. A medical home is a familiar place, with familiar people, that delivers high-quality, well-organized care that is accessible in time of need”.

So perhaps a more accurate conclusion for this study would be that larger practices, particularly those owned by hospitals and HMOs, are better at implementing processes, while smaller practices, particularly independent ones, are better at patient centeredness. Of course, it should ultimately be up to patients to decide between process orientation and patient orientation.

Obligatory Post on Google Health

2011-06-29T15:03:00.000-05:00

Not that anybody needs another post on the seemingly shattering news of Google Health’s recent entrance into palliative care hospice, but I think we may be missing something. Opinions out there range from Mr. Histalk’s summary of how Google Health is not offering anything of value to consumers, to the passionate cry for how the Google Health model is vital to health care, from Matthew Holt, and everything in between, including Jon Mertz’s view that Google Health’s Personal Health Record (PHR) was ahead of its time and should, or will be resurrected someday, with the usual comparisons to online banking and its one aggregator Mint. So which one is right? Perhaps all…..

Online banking’s main attraction is online bill pay. Online banking, which commenced in its current form in the mid ninties, would have probably languished without electronic bill pay. Paying bills is something people had to do since the days when this activity entailed hunting down a buffalo and carrying its various parts across one’s shoulder to pay for those cool moccasins with the lovely colored stitching. It continued to the day when you had to pull out a few banknotes and coins from the secret jar and run them over to the corner store to pay your tab, culminating with writing a check, placing it in an envelope, turning your house upside down to find a stamp and running it over to the mailbox, and of course you had to order checks and buy envelops and stamps in advance. Online banking allows you to pay for life’s necessities and its pleasures without moving an inch from your couch. It’s all in the wrist, and it takes 5 seconds at the most. What required a few thousands calories in the buffalo days and at least a hundred or so in the paper checks days, only takes about 5 calories of your energy today. The contribution of online banking and online shopping in general, to the obesity epidemic must be quite substantial.

The point here is that online banking is an evolution in the process of transacting business between human beings, which is as old as humanity itself. Online banking is just one more stepping stone between bartering for goods and the eventual disappearance of the archaic Gold calibrated valuation of human effort ant output. Online banking did not need to create a new market and did not need to convince customers to buy something they didn’t know they needed. As a byproduct, online banking took the intellectual effort out of balancing a checkbook. Not everybody was balancing their checkbooks, but those that didn’t were acutely aware that they should and that dire consequences are inevitable, and you could see the victims everywhere. Would people lineup to sign on to an electronic check balancer? Perhaps, but they would not log in very often, if at all. Enter the online banking aggregator. Mint was launched in 2007, well over a decade after online banking was introduced, to solve the unique problems of those with too many accounts, at too many banks, to keep track of. It’s a nice problem to have and obviously this aggregate service did appeal to a niche market. Mint says that they have 4 million registered users, but no numbers on how many registered users actually use the system. Either way, this is a rather small fraction of online banking users.

Patient Portals are to the health care sector, what online banking is to the financial industry. These are web utilities made available by the institution providing you with services (health care or banking), that allow you to efficiently perform transactions from your couch, transactions which you are forced to perform anyway. Patient Portals are rather new, certainly not a decade old just yet, and are slowly being adopted by consumers. As health services are being consolidated into larger and more comprehensive systems, just like banks historically were, Patient Portals are becoming more capable of providing efficiency and actually solving consumer problems. And just like online banking did not require interoperability between banks to become useful, Patient Portals have no such requirement either. You don’t need interoperability to make an appointment or pay a bill to Kaiser. You just need to log into Epic’s MyChart. And the same is true for many other large health systems running on Epic or Cerner or smaller technology platforms. In a few short years, most people will have accounts on Patient Portals (some more than one), and gone will be the days when you had to call the office for an appointment, call for a copy of your immunization record for school, or look for a tattered stamp to send your doctor payment in.

Google Health is not like direct online banking. Google Health is like Mint, and just like Mint had to wait over a decade after the introduction of online banking to be born, Google Health would have to wait until online health becomes a reality, examine its shortcomings and see if aggregation can solve problems for those who have too many health accounts at too many health facilities, and are wanting to balance their healthbooks. Most people don’t have enough ongoing financial concerns to actually need a Mint, just like most people don’t have enough health concerns to see value in an aggregated PHR. Sure, there are those who want to keep track of self-generated measurements of their health, just like some folks need to use Quick Books to keep financial records independent from, and comingled with, banking records. Most folks don’t feel compelled to use Quick Books in addition to bank accounts and most folks don’t have the urge to keep records of their health status outside a medical facility. Unless these market drivers change, either by popular culture shift or by regulation, Google’s business model will not be a good fit with aggregating health records any more than it is for aggregating financial records. Since Intuit, who makes Quick Books, was interested enough to acquire Mint, perhaps Apple, who has more self-measuring gadgets on its platform than any other vendor, may find an interest in health data aggregation. Call it Coconut, which is also a fruit and goes fabulously well with Mint.

Data - Free At Last!

2011-06-27T12:44:00.000-05:00

Next time you visit a doctor’s office, try to peek beyond the front desk and you will usually get a glimpse of dozens of metal shelves loaded with thousands of paper charts neatly stacked in conventional library stacks. If you have a chance to walk into the medical records department of a hospital, you will see the same, multiplied by many orders of magnitude, including folks walking around with carts full of paper charts busily putting stuff into the shelves and taking more stuff out, just like librarians do. If you close your eyes and try to imagine what health information technology is doing now, you can almost hear a huge sucking sound pulling all those pieces of paper off the shelves in a big tornado-like swirl, and into the lone computer at the front desk. Play the Walt Disney music score for Fantasia in the background while the steel shelves are swiped clean and medical records are transformed into zeros and ones and swiftly pulled into cyberspace as Data. Then an eerie silence sets upon the room and all you can hear are keyboards clicking away. No more shelves, no more carts, no more paper and very few people remaining. Somehow the computer, which has morphed into dozens of terminals scattered across the rooms, looks a lot bigger now. This is how Data becomes free.

If you stick around a bit longer, a faint trickling sound will start appearing here and there. It will grow stronger and more ominous very quickly. The Fantasia movie score has music for that too. It now sounds like a raging torrent, a waterfall of sorts, and it is coming from the computer. You can practically see the deluge of zeros and ones furiously exploding out of computer screens faster and faster until the rooms are filled with free Data. Free Data comes and goes as it pleases, and for every Byte you released into cyberspace, trillions of other Bytes have been released by others, and they are all coming your way now. In computer parlance, you are experiencing a “stack overflow” – too many zeros and ones to process correctly. As computer folks know all too well, in order to fix the problem, you must first identify its source. So where is newly freed Data coming from and why is it coming your way at all?

The first source of free Data should be very familiar to any health care provider. It consists of previously paper-bound clinical information from other facilities of care. These are the old lab reports, imaging results, prescription renewal requests and the occasional consult note, referral or discharge note. These used to make their way into an office via fax, telephone, regular mail or hand delivery by patients. Instead of being stacked on your desk for review and sign-off, the Data is now neatly arranged in to-do lists or dashboards on your computer, marked with colored icons for Abnormal, Panic or Must See, depending on your software and its particular configuration. Not to worry, the lab will still call in critical/panic results. This is one of the nicest features in EHR software and a true time saver, since you can quickly go through all results, sign-off, forward to staff and release to patients. Electronic prescription renewals, if done right, are also a big improvement on the old fax requests and endless phone calls. Various progress and consult notes travelling uninhibited into your charts can be regarded as a positive development. True, these notes are currently bloated and consist of stilted, computer generated prose, but they should get better given enough time. All in all, having professionally generated clinical Data flowing freely between medical facilities has the potential to be a huge improvement on the status quo.

And then there is patient generated Data, either the manually created trickle, or the automatically created and released flood building up behind millions of mobile devices. No one can argue that obtaining as much information as possible from a patient is a bad thing. The carefully honed art of taking histories and the thorough examination that usually follows, are both aimed at collecting as much information as possible about the patient as a whole person to facilitate diagnosis and treatment. When medical records were chained down by their paper existence, patients’ access to their own records was always mediated by a staff member and required physical proximity to the chart location. As the Data in medical records becomes free, the Data currently stored in patients’ heads becomes free as well, and the two are yearning to be joined.

Several leading EHRs are already allowing patients to access their electronic records and add their own Data, such as histories, and many more will do so in the very near future. The most obvious use of such access is the replacement of the endless intake forms before checking patients in, but patients could also update their Data at will, when things change or when they remember something new. For example, Jane Doe working with the care team on weight loss and fitness could go update the frequency of workouts or note her new all grapefruit diet plan. Someone should check Jane’s long medications list and call her right away. The grapefruit is now part of your chart and part of your responsibilities. So should you have a clinician monitor patient entries into their records on a daily basis and take necessary action? It may save a life here and there, and it may also prevent a lawsuit here and there. [Note to EHR developers: when you provide patients with write access to the chart, you should also provide the clinic with an assignable task list of all updates made in the last 24 hours, with an option to accept, deny or pend the change based on further actions.]

But the most ominous deluge of patient originated data is still gearing up for its ultimate release into the land of the free Data. There are iPhone glucometers, and iPhone blood pressure cuffs and an iPhone EKG device is almost ready to enter the market. There is even an Android application that compiles and analyzes such mundane Data as where you go and who you call or text to figure out if you may be on the verge of becoming sick. All this Data, and probably much more from a variety of sensors and labs-on-a-chip developing faster than mushrooms after the rain, will eventually be set free and find its way into your chart. We are not talking about a few hundred entries a day here, which could be monitored, albeit at major cost, by a human staffer. We are looking at terabytes of data continuously streaming up into the cloud and down into your medical records. It gives new meaning to the term “ambulatory”, since you would be presiding over an entire patient panel connected to FDA approved, ICU-like machinery wherever they go. How many EKGs can you look at every day? What if you miss one and that’s “the one”? What is the value of looking at 10 EKGs from the same “worried well” person every single day? [Note to gadget developers: without a mechanism to review and analyze gadget generated data, and without accepting legal responsibility for generating medically correct credible alerts, you will have a very hard time convincing any medical facility to open their charts to your free Data.]

It is very rarely that when a problem presents itself, it comes with a solution standing right behind it, but this is exactly the case for free Data. If iPhone apps and sensors are about to create a flood of Data, the next generation of gadgets is waiting in the wings to use this Data and divert all headaches from practicing physicians to their patients. The X-Prize Foundation is developing two new challenges. The bigger one is the famous Tricorder X PRIZE which “will award $10 million to the team that develops a mobile solution that can inexpensively diagnose patients by combining expert systems and medical point-of-care data—such as lab-on-a-chip or wireless sensors, provide a recommended course of treatment, and upload all relevant data to the cloud”. The second one is the Digital Doctor X CHALLENGE which “will award $1 million to the team that builds a low-cost, point-of-care expert diagnostics and treatment system based on a computer platform that can be operated by a minimally-trained person to accurately diagnose a range of common, regional diseases”. A combination of IBM Watson software wired to a bunch of the newest iPhone gadgets should pretty much do it. Not only patients will be able to measure everything, but for $9.99 or $99.99, they could purchase a shiny “doc-in-a-box” to take home. I assume that pharmacies will have to honor prescriptions from those devices eventually, and I assume that there will be plenty legal disclaimers to make patients fully responsible for any mishaps.

And if that’s not enough to alleviate your concerns regarding terabytes of free Data floating out there, please know that the X Prize folks have it all planned out. They are considering an X Prize for a Brain Computer Interface, which should make all the difference on how Data is set free and how free Data is processed: “The winner of the Brain Computer Interface competition will be the team that successfully demonstrates a bi-directional non-verbal brain-computer communication. Teams may use an invasive or non-invasive brain transmission device, and may train the human participant in any way they desire.” The future is here.

Excelling at Average Results

2011-06-23T20:56:00.000-05:00

Fee-for-service (FFS) is the method by which you pay your lawyer, your barber, your waiter, your cleaning lady, your airline, your plumber, your dry-cleaner, and your mechanic, to just name a few. If you expand services to include tangible products, then you pay fee-for-product (FFP) at your grocery store, bookstore, hardware store, car dealer, farmer market and any other purveyor of goods. Sometimes, you don’t pay FFS or FFP. When you purchase a subscription service like cable TV or New York Times online news, or a membership for a gym or a professional society, you pay a capitated rate for a predefined package of services that you have unlimited access to for a certain period of time, usually a year or more. A third way of paying for services is through extended warranty contracts. Here you pay a fixed fee, in advance, and the seller is committing to keep your product in functioning order, or replace it, no matter how much labor goes into this task. Warranties usually have exclusions, in very small print, spelling out exactly what repairs will not be made and usually if you are negligent in your care for the covered product, they won’t fix it under the warranty contract. You’ll have to pay extra if you want it fixed. It is easy to buy warranties for shiny new products and almost impossible to obtain coverage for older items that are more likely to break and may not be worth much anyway.

When you go to a doctor or a hospital, and you have no insurance, you will pay on a FFS basis for each encounter. You will receive an itemized bill for all services and materials used in your treatment, with the obligatory shock inducing grand total at the bottom. This is very similar to taking your car to a mechanic, except that nobody will give you an estimate before doing the work. Many times you will get separate bills from several physicians involved in your care, if they are not employed by the same facility, which is very confusing. If you have insurance, which is similar to having purchased an extended warranty on your persona, they will still send you the same bills “for your records”. If all services fall under the contractual terms of your warranty, your insurer will pay the bills, and worst case scenario, you will have to pay a small percentage of the total, which is much lower than the original asking price. If you happen to be insured by an HMO, your doctor won’t get payment for the particular bill. Instead your HMO has a fixed price contract with your doctor, which in effect means that your HMO is purchasing a third party warranty from your doctor to cover the warranty they sold you in the form of insurance. For services that are outside the warranty terms, you will have to pay full price. If you visit a subscription based concierge practice, it’s pretty much like going to the gym. You won’t have to pay anything unless you order one of those high energy smoothies at the bar.

The current common wisdom is that the FFS model in medical care is not working as well as it does in every other part of the economy mainly because most consumers are covered by those pesky warranties and therefore completely desensitized to price of services. People that buy those extended warranties at the electronics store, somehow don’t exhibit the same levels of gluttony for repair services and those warranties prove to be very good business for the seller as evident in the incessant and sometimes downright aggressive efforts to make you buy one before you leave the store. So why is it that folks don’t regularly throw their iPhones down the toilet, and don’t send their notebooks back to Dell on a weekly basis, but seem to constantly be seeking more “free” medical services? The most common explanation is that those doctors, who are not selling third party warranties to insurers and are therefore paid under the FFS model, are using their professional status to encourage the superfluous usage of their medical services for the sole purpose of personal financial gain. On the other hand, those physicians who do provide warranties on their patients under an HMO model have been often accused of withholding necessary services with the exact same purpose in mind.

The proposed solution to this quandary is to require physicians and the entities they work for to sell third party warranties augmented by Service Level Agreements (SLA) to ensure adequate quality of service. Since, if you run a small shop, it is rather hard, and very risky, to sell comprehensive warranties for something as complex as a person, most care providers are consolidating to create large shops and networks capable of providing soup to nuts services in-house. SLAs are not a new concept. In the computer industry, for example, maintenance and support agreements usually include specified uptimes, first response times and resolution times based on problem severity. They also include financial penalties for all of the above. If humans could be kept on locked racks in temperature controlled rooms, connected to adequate energy supplies and be equipped with diagnostic monitoring devices (like in the Matrix), we could easily apply very good SLAs to capitation contracts. Since this is not yet the case, and since we are talking about many millions of units, the best we can do is formulate medical care SLAs mostly in terms of percentages of evidence-based processes leading to good enough outcomes at a reasonable cost per head. So for example, if 80% of diabetics can be controlled at a cost not to exceed an average of, say $10,000 per diabetic per year, the care provider will be considered to provide good value for the dollar and therefore rewarded with some sort of performance bonus. If you can maintain 99% of diabetics controlled at an average cost of $15,000 per diabetic per year, you’re out of luck, and the same goes for achieving only 50% control regardless of the price. This is called Value Based Purchasing (VBP) and this is how insurers will be contracting with increasingly larger provider organizations to supply medical care to increasingly larger populations.

This model of paying for services is not necessarily bad, since we probably have a long way to go before most providers are able to meet the currently proposed SLAs. We can also keep pushing the SLAs up incrementally, and by tightening controls on both consumers and providers, we should be able to reduce variability of processes and standardize enough to achieve Six Sigma on measures shown to best contain overall costs of care. Of course, in this zero sum system, there is no room for outliers. Just like spending all day trying to fix one stubborn server can derail maintenance on a farm of thousands of machines, and may even get you fired, providing heroic and very expensive medical care to one individual is directly detrimental to assigned population needs and may cause serious financial loss to the provider. Every rookie computer engineer knows that in large enough server farms, it is best to ditch a malfunctioning server. You won’t even feel it. That’s the whole point of having server farms. Now if you work for a small business and all you have is one lonely rack of servers, and they all have names (the Oracle box, the NAS, the web server, etc.), you’ll work all day and all night to keep each and single one alive. You’ll get fired if you don’t.

Fulfilling the PROMISe

2011-06-20T13:06:00.000-05:00

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

2011-06-09T02:50:00.000-05:00

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

2011-06-04T11:57:00.000-05:00

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:

Health Information Technology to assist with documentation, information exchange and measurements as required in any coordination effort.
Incentives and penalties for providers based on measures thought to be influenced by care coordination (e.g. preventable hospitalizations, readmission rates, etc.)
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

2011-05-26T22:47:00.000-05:00

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

2011-05-23T00:23:00.001-05:00

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

2011-05-13T15:04:00.000-05:00

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

2011-05-01T17:19:00.002-05:00

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?

The Kübler-Ross Model of EHR Adoption

2011-04-24T20:29:00.003-05:00

Elisabeth Kübler-Ross, MD

For over a hundred years the paper chart has been a trusted partner and best friend to many physicians and nurses. The paper chart was born the day a new patient walked into the office, a pristine, crisp and neatly color-coded folder, with just the right markings in carefully shaped calligraphy on its covers. As the years went by, the paper chart grew in size, acquired meaning and wisdom, and like most of us, became a bit tattered around the edges and heftier in the middle. It felt good to hold the elderly paper chart in your hands and its voluminous physical presence inspired confidence and trust. The paper chart is dead. In some places the paper chart’s pages are still turning slowly, but we all know its long, productive life has come to an end and someone should pull the plug and call it. Or do we?

In 1969 Elisabeth Kübler-Ross proposed a 5 stage model for typical grieving behavior. The various reactions from the clinical community to the apparent demise of the paper chart exhibit almost textbook adherence to the Kübler-Ross model, with each clinician advancing through the five stages of grief at his/her own pace*.

Denial – This is a joke. These people don’t understand medicine and this entire Obamacare thing will soon go away and we’ll return to normalcy. My practice is doing just fine on paper and my patients get all this fancy medical home care right here and always had. They actually get better care. Besides, I have patients to see and I am too busy to tinker with these fads that come and go every five years or so.

Anger – This is a cruel joke. This EHR thing is just a government ploy to punish doctors and enslave them. There’s nothing in this for me and you want me to pay for it?? We are all going to stop taking Medicare, Medicaid and all your government plans, which don’t even pay for my receptionist, see what you do then. Heck, why stop there? There will be no doctors left, period, because nobody is going to accept such humiliation and no bright students will choose medicine as a career. We can all do much better doing other things. I didn’t go through ten years of medical school and residency and pissed my entire youth away just so I can become your personal data entry clerk. You want data? Enter it yourself and feel free to treat yourself too. Go Google it, or go to an NP at the grocery store. Not to mention that these EHR contraptions are killing thousands of people every day because nurses are tending to EHRs instead of patients. Is that what you want? Suit yourself. I’m out.

Bargaining – This is not happening to me. This does not have to happen to me. I am a doctor. If I stop playing their game, they’ll have no way to touch me. I will only take cash, at least for a while, until this thing blows over. My patients love me and I will take better care of them than any computer can. They know that. They are willing to pay for a true doctor/patient relationship and my undivided attention. I have friends that switched to concierge practice and they’re doing great. I’ll practice good medicine, and in time everybody will come to their senses and see that this is the right way to care for people. They will see the errors of their way and everything will be back to normal. I just have to make it through the next couple of years.

Depression – What’s the point? Why did I have to sacrifice my entire life and work like a dog for these ungrateful people? There’s no respect any more. There is no gratitude. There’s no money in this either. I should have gone to law school and spent my time ripping everybody off like those shyster lawyers do every day. They want me to be a cog in their Toyota production line for people. I don’t know anything about computers. I can’t even type. Why should I? Doctors don’t type. There is no point. Can’t even give this practice away, let alone sell it; might as well just walk out right now. I have a little money. I don’t need to work. I’ll retire early. I’ll play golf all day. Maybe go into consulting for those thieving insurers. One thing’s for sure: no child of mine is ever going to medical school. It’s over.

Acceptance – This EHR is really primitive. Costs a fortune, but the hospital kicked in for most of it. They want to measure my performance; fine with me. I’m a good doctor and I take good care of my patients. I don’t like using the computer in the exam room. My nurse does though, but you should see her texting, and my receptionist says it’s better than the old system. I wish I could get the hospital labs, but they’re still faxing them over. They say it will get better. I don’t know. I have an iPhone and it has an app for medications, which is really nice. I have email and some patients use it. Not too many, but it’s nice too. I signed up for this new telehealth program starting in the fall. My father practiced for 40 years down in the valley. He wasn’t home much, but sometimes he took me along on house calls. Saw the first baby born when I was eight. I don’t think you can deliver a baby on telehealth, can you? Well maybe if there’s a midwife out there and you watch just in case… Never mind. I love practicing medicine. It’s hard right now, but I think I have another ten-fifteen years left in the tank, and if it gets much tougher, maybe I’ll just go work for the hospital. They already have my charts anyway.

But here’s the deal, folks: the chart is not really dead. It just underwent major reconstructive surgery. It has new legs and new organs and a new face, because, unlike people, they can do that for charts nowadays. Sure, it looks terrible right now, all stitched up and bruised and so very helpless, hooked up to wires and machines. It can’t do anything for itself. It moves slowly and sometimes just collapses under its own new weight. You will have to teach it how to use its new legs and train it to engage all those brand new bionic organs. It will take time and lots of physical therapy. It is a big commitment and there will be setbacks and more surgeries down the road. You could just walk out and leave it to its fate and to others to nurture it back to a useful life. Or you could take it home and tend to it, and every day be amazed at small miracles and watch it slowly get stronger, better and more beautiful, surpassing your wildest expectations, until it becomes the indispensable, trustworthy and useful friend it always has been, with a brand new lease on life for you both.

*All first person utterances in this post are fictitious. Any resemblance to what anybody may have said or communicated to the author during times of great frustration is purely coincidental.

Shared Sacrifice

2011-04-22T12:57:00.001-05:00

The Internet is abuzz with Attestation fever. CMS has officially opened its website service for physicians and Hospitals to attest to achievement of Meaningful Use for 2011. It is expected that stimulus incentives, as mandated by ARRA’s HITECH Act, will soon be flowing out to the new Meaningful Users to the tune of $20 Billion (or more) over the next five years. Meaningful Users are a very diverse population and range in scope from a solo practice in the middle of nowhere with a rickety EHR purpose bought for these incentives, to Kaiser Permanente with thousands of employed physicians, dozens of hospitals and gold-plated enterprise technology worth many billions of dollars, purchased and implemented years before HITECH saw the light of day.

Last year Becker’s Hospital Review published a list of “52 Not-for-Profit Hospital Systems to Know”. Those are the largest and most excellent integrated health delivery systems in the country. Between them these 52 leaders in health care delivery have about 900 hospitals of various sizes and most have hundreds and thousands of employed physicians, both in inpatient and outpatient practice. Many of these organizations are faith based and were founded years ago with the goal of providing care and comfort to the sick. Today, these non-profit systems are leading the way in quality improvements, adoption of health care information technology and innovative ways to provide better and more cost-effective medical care, and most, if not all, have healthy and profitable bottom lines, while actively engaging in charitable contributions to their communities.

As CMS is gearing up to disburse the ARRA stimulus incentives, it stands to reason that a significant portion of the money would go to these non-profit leaders of our health care system. As anyone trying to figure out the exact amount of incentives for any given hospital knows, the exact calculations are rather cumbersome. HIMSS estimated that the Medicare incentives for a hospital could range from $3.5 million for a 75 bed facility to over $11 million for a 750 bed hospital, over the entire stimulus period. It is worth noting that, unlike physicians, hospitals can qualify for both Medicare and Medicaid incentives, significantly increasing the estimated amounts for Hospitals with a large enough Medicaid population. What follows is a very conservative attempt to estimate the percentage of the proposed $20 Billion ARRA incentive that will more than likely flow to these 52 non-profit Hospital systems.

Let’s assume that the average hospital in this group will collect only $5 Million from both Medicare and Medicaid, which puts the average hospital at about 200 beds and accounts for some hospitals that will not be able to qualify for incentives. Let’s also assume that an outpatient physician has 5000 patient visits per year (which is very high), and when encounter data is not available, let’s assume that only half of employed or affiliated physicians qualify for incentives under Medicare, and none qualify for the higher Medicaid stimulus. For very large systems, where data is not readily available, let’s assume that there are no eligible professionals and all incentives will come from the Hospital side of the house. Based on these very conservative assumptions and any 2010 annual report data found on various systems websites, here is how some numbers shape up:

Kaiser Permanente – 35 hospitals and 36.6 million doctor visits – is looking at about $0.5 Billion total incentive payments.
Trinity Health – 45 hospitals and about 8000 physicians – will collect around $0.3 Billion in the next five years
Sutter Health – 25 hospitals and 3500 physicians – comes in at around $0.17 Billion in incentives
Providence Health – 26 hospitals and 7 million visits – will qualify for almost $0.2 Billion
North Shore LLJ – 14 hospitals and 7500 physicians – should obtain over $0.2 Billion in stimulus payments
Intermountain – 23 hospitals and 750 physicians in their medical group – will receive well over $0.1 Billion

All in all, if we just consider the 900 hospitals these systems have in common, and ignore the outpatient payments, the total incentives due are around $4.5 Billion total. This number will go up significantly if we account for the various eligible professionals payments, running at $44,000 per physician under Medicare.

In the large scheme of things, a few Billion dollars is not that much money. Withholding those billions will not fix the deficit and will not put a visible dent in our health care expenditures. No single act of savings will solve the dire problems present in our health care system and the country in general. President Obama is calling for us all to contribute to a solution and share the sacrifices needed to rectify the situation. In a perfect world, Shared Sacrifice is not something that should be imposed by government. It should be a grassroots effort where everybody agrees to give up a little and come together in one unified force for the public good, but someone has to go first, someone has to step forward and make the first sacrifice. Today is Good Friday.

To these 52 benevolent paragons of health care, in the spirit of the selfless and saintly men and women who, many years ago, founded your organizations with the single mission of aiding and comforting the sick: Don’t take the money.

And if you must take the money, because of irrelevant legislative technicalities, turn around and give it all to the poor and sick and needy people in your community. A few billion dollars will not solve the big problems, but a few dollars may be enough to provide a sick elderly person one more hot meal, or buy one more pair of glasses for a child so he can stay in school, or provide one more bottle of prenatal vitamins to a pregnant woman and maybe even allow for one more hospice day for a dying man. And above all, you will set an example for us all, and maybe even change the spirit of this country, so we can all do better by doing good first.

The Health Insurance EHR

2011-04-16T20:30:00.001-05:00

Kaiser Health News recently published excerpts of an interview with the CEO of Aetna, Mark Bertolini. Interesting article and interesting subject, but one thing Mr. Bertolini said in connection with Aetna’s acquisition of Medicity, a vendor of Health Information Exchange (HIE) platforms, caught my attention: “We are as much a health information technology company as an insurer”. United Healthcare has also been engaged in significant HIT acquisitions for quite some time. They bought an EHR, Care Tracker, and an HIE vendor, Axolotl, amongst other things. According to the Aetna CEO, in order to create a system that functions properly, insurers “have to be able to provide an infrastructure”. So is this the future? Will health insurance giants be providing insurance coverage to customers, and HIT infrastructure, including EHR software, to physicians and hospitals?

Most HIT experts are forecasting consolidation in the EHR market, which is currently fragmented into hundreds of less than optimal disparate software products, but is anybody seriously contemplating that the emerging forces in health care technology will be the payers? If you think about this for a moment, and if you remember doctors’ plight that EHRs mostly benefit payers, this outcome doesn’t seem so far-fetched. After all, selling health insurance and selling EHRs follows pretty much the same paradigm.

Company Website – Health insurance companies have beautiful websites loaded with pictures of happy people and the cutest babies. EHR vendors have equally high-gloss websites with lots of Flash banners, happy doctors holding shiny tablets in pristine clinics, and, strangely, some also have the cutest babies and toddlers bouncing on every page. Neither one has any useful information for someone shopping for a product unless, of course, you provide them with your contact information, in which case you will be getting a very energetic sales call.
Price Transparency – When you buy an insurance policy, all you know for sure is what premium you will have to pay every month. Most folks don’t realize until it is too late that they will have to pay for all sorts of other things that are “not covered”. Similarly, when you buy an EHR for $399 per month, little do you know that there is at least the same amount of hidden charges, and unexpected “upgrade” fees imposed whenever the vendor feels that it needs to improve its top line.
Contracts and Policies – Health plans have notoriously long and convoluted policy documents aimed at confusing the buyer. I don’t know too many people who are competent enough to read and understand their content. EHR vendors are a bit ahead of the game here since they also have carefully staged vaporware demos and their contracts, although shorter, are as good as the payers’ policies in obfuscating real terms and conditions, which become painfully evident only when disaster strikes.
Freedom of Choice – Most people, including the vast majority of employed citizens, has increasingly little to say about which health insurance plan they end up with. Employers, who pay a large portion of the cost, either pick a plan based on business considerations, or just self-insure. Employees are forced to do the best they can with whatever they were dealt. As more and more independent physicians are being acquired, and salaried, by large systems, they too have very little to say about what EHR will end up in their exam room. Those who are still somewhat independent, but herded into various affiliations, are rarely able to check a gift horse in the mouth and end up taking whatever the large system is providing under Stark law relaxations.
Rationing – Health insurance is expensive. The wealthy and those with large and conscientious employers are able to gain access to fairly decent insurance coverage. Some may even have so called Cadillac plans. The poor and unemployed must shop for insurance with no bargaining power and their dollar usually buys a lot less coverage. Large hospitals and specialty medical groups can afford to buy the fancy gold-plated EHRs and they often do. Small and rural primary care practices can’t even come close to being able to afford an EHR from an industry leader. And similar to the private insurance market, a solo doc, with no bargaining power, will end up paying more than a physician in a large practice for the exact same EHR.
Government – Unless you live on a deserted island, you know that by 2014 the individual mandate will be kicking in and everybody will have to buy insurance or pay a penalty. Also by 2014, every American is supposed to have an EHR, which means that every physician will have to buy EHR software, or pay a penalty in the form of reduced Medicare reimbursement down the road. Both regulations may be viewed as voluntary since you could choose to pay the penalty, which is much lower than the price of the mandated products. And in both cases Government proposes to determine the minimum requirements for what you can buy to avoid penalties.
Product Design – We all know that health insurance policies are designed by bureaucrats and bean-counters to maximize payer profits, with complete disregard for patients’ lives and doctors’ advice (or at least that seems to be the common wisdom). The parallel mythology asserts that EHRs and HIT products are created by “programmers” and other “geeks” with no knowledge of, and no respect for, established clinical workflows and with the same disregard for patients’ lives and safety.
Good Ole’ Days – Ah, those days gone by, days of beautiful simplicity, when Government minded its own business, and everybody paid for medical care out of their own pocket, except those who had nothing in their pocket. Those days of wonder when the most medicine could offer was lancing boils and mustard plasters in return for a hefty slice of rhubarb pie, and an amputation went for a couple of chickens. The olden days with hospitals run by selfless nuns in full habit, doing God’s work on earth, where the very sick were freely admitted, but nobody was ever discharged. A gentler era when people died at home from romantic ailments like consumption, surrounded by family and friends, or succumbed en-masse to plagues with mysterious “putrid” origins. The days of golden fountain pens and neatly stacked notecards in little clinics manned by workaholic doctors and spinster nurses clad in white starched uniforms. Yeah, well, that’s over now.

We are entering the Big is Beautiful era in health care. Big government with big regulations, created in deference to big corporations, will only allow big insurers and big health care delivery systems to thrive. They will be using big computer programs with big algorithms simulating big artificial knowledge and intelligence, administering to the big needs of big populations with big risks and big payoffs. Not to worry though, big insurance has figured this all out, as evident from Mr. Bertolini’s big vision:

“We will shift risk (financial responsibility for medical costs) to the provider system. We’ll provide them cover with capital as re-insurers. We will be the Intel-inside, if you will. We have dozens of these conversations going on with major systems. We spend $400 million a year on new developments: We are as much a health information technology company as an insurer. Our U.S. health system is not really a system as much as a bunch of independent players. How do we create a system that functions properly? When my dry cleaner knows more about the whereabouts of my shirts than my doctor knows about the whereabouts of my X-rays, we have a problem. We have to be able to provide an infrastructure. ”

Yes, just like dry cleaning. We find the X-rays and we’re all good. Brilliant!

Patient-Centered EHR

2011-04-10T12:40:00.000-05:00

The term patient-centered has become a serious contender for the most flippantly used term in health care publications and conversations. Of course meaningful use is still #1 on the popularity charts, with ACO quickly moving up, but even meaningful use and ACO are almost always accompanied by patient-centered as a way to add legitimacy and desirability to the constructs.

Even Paul Ryan’s new recipe for fiscal Nirvana is touting patient-centered health care as one of a litany of fictional achievements made possible based on an array of wishful thinking assumptions. But perhaps the most common usage of patient-centered terminology is the Patient Centered Medical Home (PCMH), which is touted as the ultimate patient friendly solution to our health care difficulties. Since PCMH is heavily reliant on Health Information Technology (HIT) to achieve patient-centeredness, and since Meaningful Use of Electronic Health Records (EHR) is being increasingly aligned with this goal, it may behoove us to explore the features and functionality that would qualify an EHR to support a patient-centered approach to health care delivery.

But first, what exactly is patient-centered health care? From reading the NCQA medical home specifications, the Meaningful Use definitions, the HIT suggestions from PCAST and the brand new ACO regulations, all of which assert a patient-centered approach, one would conclude that patient-centered care is made possible by providing all patients with timely electronic access to the entirety of their medical records including lots of patient education, electronically coordinating a multitude of transfers of care, empowering non-physicians to provide most medical care, measuring a bewildering array of health care processes and constantly evaluating and reporting on population metrics, while somehow allowing patients and families to express their wishes regarding the nature of care within the boundaries specified by each proposal. I am excluding the Ryan budget proposal here, since other than having “patient-centered” typed in various spots, there is no reference to actual health care delivery, or what is left of it after most seniors, sick and disabled folks are reduced to begging for medical care. Computers and EHRs can, and to some extent already do, support many of the above activities, but is this truly patient-centered (singular) care, or should we add an “s” and refer to a plurality of patients-centered, or population-centered, care?

In 2009 in a landmark Health Affairs article, Dr. Berwick summarized patient-centeredness as follows: “The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care” and he very much liked the Harvard maxim “Every patient is the only patient”, since it implies an “attitude of “guest” in the patient’s life, and it also expresses confidence in the feasibility and desirability of customization of care to the level of the individual”.

When articulated this way, patient-centeredness becomes more of a mindset directive for those who provide medical care and those who design health care delivery systems. There is precious little that an EHR can do to ensure patient-centered care, and most all it can do is act in a supporting role, as it always should, for patient-centered health care providers. This is not to say that the computer-enabled capabilities to evaluate, manage and measure population health indicators, such as registries and clinical process measures are not beneficial, but these computerized aggregation and management tools have almost nothing to do with the concept of patient-centeredness as expressed by Dr. Berwick.

EHRs are more than an electronic chart. Even for small practices, EHRs are also enterprise/business management software. In both capacities, EHRs can contribute their fair share to a patient-centered approach to health care. The following list is not intended as a complete EHR design document; instead it is a collection of technical features and functionalities that could be rather easily added to existing software in an attempt to help place the individual patient at the controlling center of health care provision, according to Dr. Berwick’s vision of patient-centeredness.

Transparency – A well-documented medical record shared in its entirety with patients through a Patient Portal would go a long way to provide transparency into medical treatment decisions, but in its current form an EHR may be too lengthy and too complex for most patients (and most physicians too) to follow and comprehend. Many of today’s EHRs include patient education materials regarding a particular disease following diagnosis, a medication that was just prescribed, or a particular diagnostic test ordered. It would be infinitely more conducive to transparency if Patient Portals would include full subscriptions to such sites as UpToDate and test results documentation, including reference ranges and abnormals for each test resulted in the chart, in plain and simple language. Another patient-centered feature available in many EHRs is the longitudinal record (or flowsheet), but this is rarely, if at all, available to patients. Providing ability for patients, particularly those with chronic conditions, to obtain and customize longitudinal views of their health records would allow patients to understand how various therapies and various behavior modifications are affecting their wellbeing and their disease progression. If and when, the business side of the house allows it, EHRs can be extremely helpful with price transparency, since computers are best at calculating various options and optimizing figures. I can see price calculators sprouting up in Patient Portals allowing patients to locate and compute the most affordable treatment option for their individual circumstances.
Individualization – I am pretty sure that Dr. Berwick was referring to much more consequential events here, but in a small way, EHRs can contribute to tailoring experiences to individual needs. For example, an EHR should know the age and education attainment level of an individual patient. As a result, it could display very little text and lots of pictures for the very young, and perhaps larger fonts and more advanced content for the retired professor, or more numeric data and statistical information for an engineer. Something as simple as making sure every graphic has an alternative textual description and every mouse action has an equivalent keyboard action, would be very helpful for patients with impaired vision. An EHR would also know if the patient started a new medication recently, so it could preemptively solicit patient input on how things are working out and provide that information back to the nurse. Generally speaking, there is a wealth of personal information in an EHR that with some creative thinking could be used to provide individualized experiences to each patient.
Recognition, Respect, Dignity – These are a tall order for a piece of software to facilitate. Nevertheless, there are little things that could help. Even the most thoughtful clinician cannot remember everything about each patient at all times. How about allowing the patient to insert one short reminder in the EHR, to be displayed each time someone opens their chart? A simple thing like “scared of room with clown picture” will save mom, baby and doctor a lot of trouble during a routine visit. Or relating to Dr. Berwick’s fear of being called Donald by an anonymous nurse in a hospital, a chart could have a little reminder to address the patient as Dr. Berwick or Don. Trivial to implement. And here is something to alleviate the “anonymous nurse” problem. Remember those patient photos that every self-respecting EHR has in the chart? How about having photos of all treating clinicians also display in the patient chart? Most folks have no trouble remembering what their doctor looks like, but if the patient is very young, or very old, or in the care of many specialists, it may be very helpful at times to have a visual record handy, and this is trivial to implement as well.
Choice in all matters without exception – EHRs cannot make policy, but as described above they can aid patients with obtaining information to make the choices allowed by the system they find themselves in. It is important that the information provided to patients through EHRs should have no administrative bias, and I would prefer an unedited, reputable third party source. For example if a brand new ACO decides to cut expenses by increasing utilization of palliative services, patients should not be covertly influenced to forgo other, more expensive, options with a carefully selected collection of education materials. Basically, EHRs should maintain integrity of clinical information and not allow management manipulation of vulnerable patients for financial gain. I believe regulatory intervention should be required.

Related to one’s person – The first thing that comes to mind here is advanced directives, and Meaningful Use is moving in the direction of requiring all EHRs to have the capability of creating and storing advanced directives. Coupled with advances in information exchange, this feature should ensure that folks are treated the way they want to be treated when the end is near. Much care needs to be exercised when those directives are available to the patient and his/her family online to create and modify.
Related to circumstances – Most privacy and security minded EHRs have a mechanism for allowing physicians emergency access to records for patients who are not under their care. This type of access, termed “breaking the glass”, is logged and audited to prevent improper access. Patients have emergencies too and many times they don’t know who to call or what to do. This is not about the 911 type of emergency, or the midnight earache when one can call the exchange. This is about truly unusual circumstances, when you know something is very wrong, perhaps during a hospital stay, and speaking with your physician or surgeon is imperative. EHRs could provide this safety valve, with appropriate telephony forwarding rules and controls to prevent abuse.
Related to relationships – By definition relationships are between people, but once relationships are selected, EHRs can help solidify and formalize their existence. For example, the original PCMH definition listed a personal physician at the top of the list of core features of a PCMH. Although the current NCQA requirements for PCMH certification do not explicitly pose this requirement, an EHR can help an individual patient who is fortunate enough to have a personal physician make good use of this feature. An EHR should display the personal physician name on every screen where patient specific data is displayed. All patient data should be tagged with the personal physician identifiers for purpose of clinical data exchange so that anyone viewing a patient’s records will immediately know who is the patient’s trusted advisor, advocate and representative, and where all medical information needs to be sent. The originating EHR should automatically copy all orders, results, procedure notes, admissions and discharges to the personal physician.

Finally, remembering that “every patient is the only patient”, we need to consider what EHRs should not be allowed to become. EHRs should resist the temptation of surrounding physicians with layers and layers of electronic data and communications, until each patient becomes nothing more than another blip of bits and bytes in an endless stream of the same. EHRs should not be constructed with a primary mission of collecting research and evaluation data points, either about patients or their doctors. Those who build EHR software, and those who regulate what is being built, should remember that if a treating physician is a guest in a patient’s life, researchers, population managers and governments are very much uninvited guests, and as such should humbly wait by the door, hat in hand, and respectfully accept whatever patient-centered care can spare for their secondary uses of data.

The ACO Rules & Privacy

2011-04-01T15:45:00.007-05:00

One day before the first of April, HHS published the much anticipated rules defining the creation and operations of Accountable Care Organizations (ACO) spanning 429 pages of business regulation, analysis of various options available, proposed solutions and ways to measure and reward (punish) success (failure) in achieving HHS seemingly incompatible goals of providing better care for less money. I am fairly certain that health policy experts, health care economists and the multitude of industry stakeholders will be dissecting and analyzing the hefty document in great detail in the coming weeks. I started reading the document with an eye towards the ACO implications for HIT, which as expected are many, but something on page 108 made me stop in my tracks. HHS is proposing to share personally identifiable health information (PHI) contained in Medicare claims with ACO providers unless patients “opt-out”.

Beginning on page 108 and through 22 pages of tortured arguments, HHS makes the case for the legality and benefits of providing ACOs with PHI contained in Medicare claims, unless the patient actively withdraws consent for this type of transaction. The argument for the legality of claim data sharing rests on the nebulous HIPAA clause which allows disclosure of PHI for “health care operations” within a web of covered entities and business associates connecting the ACO with Medicare and other providers of health care services for a particular patient. HHS is proposing to make available four types of medical information to participating ACOs:

Aggregated Data, including ACO generated and non-ACO generated data, stratified and analyzed to obtain quality measures, population risk scores and indicative behaviors such as emergency room visits, hospital discharges, prescriptions and physician visits. Although this data is presumably de-identified, in a small ACO with 5000 patients, it shouldn’t be too difficult to attribute this data to particular patients. HHS proposes to provide such data to ACOs on a quarterly basis.
Four Personal Identifiers – name, date of birth, gender and Medicare ID – for all historically ACO-assigned patients included in the aggregate data reports above. To circumvent the Privacy Act which prohibits Federal records systems from disclosing identifiable information without written permission, HHS is invoking the allowed exception for purposes of “routine use”, which requires a notice to this effect to be published in the Federal Register, after which these four identifiers may be released without consent.
Personally Identifiable Claim Data – Here HHS is proposing to provide participating ACOs, upon request, Part A and Part B claim data on a monthly basis. The data elements that will be provided are: “procedure code, diagnosis code, beneficiary ID; date of birth; gender; and, if applicable, date of death; claim ID; the from and thru dates of service; the provider or supplier ID; and the claim payment type”. This data will be provided for patients who have had a visit with a primary care physician participating in an ACO during the performance year. Alcohol and substance abuse records are excluded from disclosure.
Prescription Data – A subset of Part D medications claims data is also proposed to be disclosed similar to Part A and Part B data above. The minimum set includes “beneficiary ID, prescriber ID, drug service date, drug product service ID, and indication if the drug is on the formulary”.

The first two disclosures (aggregated data and the four identifiers) are proposed to occur regardless of patient consent or lack thereof. The ACO rules propose an opt-out mechanism for patients who want to prevent disclosures in items #3 and #4 above, and it seems that the opt-out option is not a legal requirement, instead it is based on a belief system at HHS: “Although we have the legal authority within the limits described previously to share Medicare claims data with ACOs without the consent of the patients, ………. We nevertheless believe that beneficiaries should be notified of, and have meaningful control over who, has access to their personal health information for purposes of the Shared Savings Program”. [Since the Medicare ACO model is intended to be adopted by payers other than CMS, one is left to wonder about the belief systems prevalent at those private organizations.]
The actual opt-out process proposed in the document consists of a conversation with a provider during which “the beneficiary would be given a form stating that they have been informed of their physician's participation in the ACO and explaining how to opt-out of having their personal data shared. The form could include a phone number and/or email address for beneficiaries to call and request that their data not be shared”. So it’s not as simple as checking a box in your doctor’s office.

For over a year ONC’s Policy Committee has been grappling with privacy issues as evidenced by the tremendous work occurring both in the Privacy & Security Policy group and Privacy & Security Tiger Team. The issue of consumer/patient trust in Health Information Exchange (HIE) and Electronic Health Records (EHR) has been repeatedly recognized as a necessary ingredient to widespread HIT adoption, and much effort has been invested in devising policies and standards to allow consumers control of their medical records in general and sensitive parts of their medical records in particular. The recent report from the President’s Council of Advisers on Science and Technology (PCAST) includes recommendations to allow patients to attach privacy controls to each separate data element in their medical records. An ONC specially appointed workgroup tasked with analyzing the PCAST report has identified privacy as an issue of concern in a possible implementation of the PCAST recommendations.

What is the purpose of all this hard work, all these committees and workgroups, all expert testimonies and public comments, hearings and debates, if CMS, in its capacity as a payer, can assume legal authority to bypass all privacy controls embedded in EHRs and HIEs and disclose medical records information, as reflected in claims data, based solely on what CMS, or any other payer, believes is necessary and proper at a particular time?

In Defense of EHR Weapons of Mass Destruction

2011-03-27T18:14:00.002-05:00

Remember the fear mongering rhetoric about weapons of mass destruction and all sorts of other bogey men that sometimes led to war death and true destruction and other times to just animosity, hatred and counterproductive waste of time and resources? This is exactly what we are witnessing today in Health Information Technology (HIT). Granted this is only a sideshow, while the main stage is occupied by the unprecedented Federal push to computerize medicine, but it has a very shrill voice and it seems to be confusing many good people. There are many legitimate questions that need to be asked, many strategies that should be debated, many errors that must be corrected, but the unsubstantiated, dogmatic and repetitive accusations directed towards HIT in general, EHR in particular, and chiefly at technology vendors and their employees, are borderline pathological in nature.

To be clear here, there are many practicing physicians and nurses who are either forced by an employer to use an EHR they dislike, have tried to use an EHR and didn’t enjoy the experience, or are opposed to the EHR concept on principle because the software has no return on investment in their situation, is not “ready for prime time” or is too closely aligned with the goals of the Federal government. These are all valid points of view and should be listened to and considered by policy makers as well as technology builders, and I have to confess that I do agree with much of what these practicing folks write and say, and as I said many times in the past, practicing physicians, i.e. those who see patients every day, are dangerously underrepresented in all HIT policy and technology decisions being made now at a federal level. Unfortunately, the practicing doctors’ message is being obscured and tainted by the “naysayers who predictably and monotonically chant the “HIT is evil” mantra at every opportunity” (quoting the famed HIT blogger, Mr. Histalk). These “self-proclaimed experts” and their incendiary and largely self-serving monologues are making it very easy to dismiss legitimate problems present in HIT policy and technology.

The #1 allegation against EHRs and those who build them is probably the one contending that EHRs kill people. HIT is supposedly an unauthorized human subject experiment which should be halted due to so many deaths and injuries. There is no evidence to support this assertion. Yes, there are several deaths documented, which have been associated with EHR software in one way or another, all in hospitals, but there is no documented evidence of mass injuries. The ugly truth is that people die in hospitals due to preventable errors of all types. They died before EHRs were introduced and they are still dying at similar rates after EHRs were installed. For every error attributed to software malfunction, there is a parallel error that can be attributed to lack of software or utilization of paper charts in general. For example, a software bug could cause records to end up in the wrong chart. How many times do paper records get filed in the wrong chart? How many times do paper records get misplaced never to be found again? How many times do paper charts disappear for long periods of time? Of course since paper is a passive medium, all errors arising from paper charts usage are directly attributable to users. When an EHR is used, some errors, not all and not most, are attributable to the software. Ergo, EHRs kill people while prior to EHRs people killed people. Net effect is the same, although fixing software bugs is a lot easier than remediating people’s error prone behaviors.

The #2 inflammatory allegation is squarely directed at the business entities that build and sell EHRs, and individually towards anybody associated with IT, whether at a hospital level or a vendor level. Supposedly, these dim-witted IT folks have no understanding of medical practice and a complete disregard for patient safety and human lives. I have no doubt that some IT folks would not score very well on Mensa tests and others may have little interest in anything other than their paycheck, and this is true about any randomly selected group of people, including clinicians. However, EHR vendors are for-profit technology companies, and as such have an overriding interest in creating revenue. You do not benefit your long term top-line by purposely selling defective products. Suggestions that EHRs should be produced by non-profits are a bit naive considering that this is health care we are talking about, and we all know how selfless, charitable and patient safety oriented other non-profits are in this industry. I would also like to point out the few and far between health care providers who are willing to treat Medicaid patients due to financial and business considerations. How are the sacred patient safety and human life considerations ranked by those providers? I would assume they come in right after staying in business, keeping the doors open and perhaps even an acceptable profit level. EHR vendors are no different.

As to hospital IT folks, the ones I had the pleasure of meeting always listed patient safety as their main concern. Was it just lip service? I don’t think so, but all I have is anecdotal evidence. In any case, the incompetence and profit concerns of hospital administrators who drive EHR deployments in hospitals and health systems, to the extent that they exist, are not indicative of HIT being murderous or evil. They are indicative of the need for transparency and learning from those that manage to deploy the same HIT tools successfully, and those do exist.

Moving on to #3, we find the widespread platitude contending that EHRs should be built “by doctors for doctors”. Guess what? Many are, and it doesn’t make those EHRs any better. Amongst the larger EHR vendors, there is none that does not employ physicians and some have dozens of MDs on staff and hundreds of other clinicians. Many medium and smaller EHR companies were founded, and some are still owned, by physicians. There are two issues here. One is that most physicians fully employed by technology companies are not practicing anymore and I am not certain they ever did after residency. I have personally witnessed multiple times the huge disconnect between the professional IT physicians and those seeing 30 patients each day. Couple that with the “I’m a doctor, so I know best” attitude, and you are guaranteed an academic product that will have little value in the “real world”. The second issue is that most physicians know as much about IT as engineers know about medicine. With very few exceptions, commercial EHRs should not be built by doctors as a side hobby. They should be built by professional software designers and builders with extensive input and guidance from customers, just like quality products are built in all other industries. And by customers, I don’t mean “ivory tower informatics experts” who happen to have an MD after their name. I mean hard working, six days a week, frazzled and discouraged, practicing doctors and nurses.

Finally the #4 issue is the perpetual cry from various quarters that EHRs should come under FDA supervision. I strongly agree. Any instrument used in the delivery of medical care should be supervised to an appropriate degree, and maybe such transparent supervision would put an end to the fictional assertions that EHRs are guilty of mass murder. Done right, FDA supervision will definitely help folks make better product choices and deploy and use EHR technology in more beneficial ways. With the recent proliferation of “certified” EHRs, triggered in large part by the glow of HITECH money, FDA supervision could also serve to separate the wheat from the increasing amounts of chaff. It is also useful to remember that people are killed every day by FDA approved drugs and devices due to improper use, human error, negligence, criminal intent and product faults that the FDA missed.

In conclusion I would be remiss if I did not mention the multiple legitimate complaints regarding EHR usability and utility. While there is much work to be done, many errors to be addressed and much technology innovation to be applied, the form and function of EHRs is ultimately dictated by the environment in which they are used. The business of medicine (a.k.a. billing) dictated most of the box-clicking nature of older EMRs and the new population health, cost cutting and research focus emanating from the Federal government will just increase the demand for structured data elements and the accompanying clicking on boxes. EHR vendors will build whatever customers are willing to buy. It is infinitely easier to build an EHR without click-boxes and templates, than it is to build one that records and maintains hundreds of templates, customizations, vocabularies, cross-walks, guide-lines, protocols and analytics to slice and dice everything. Vendors would be more than happy to just give you a blank text box where you can type, scribble or dictate to your heart's content. But guess what every single physician looking to buy an EHR is asking right after the price question? “How many templates does your system have for my specialty?” The structure of EHRs is a symptom of quite a different problem and it will not be resolved until the root cause is addressed. So the lunatic fringe notwithstanding, EHR vendors are not out there to torture you or kill your patients. They are out there to sell you products and services and make some money in the process - just like Apple, Microsoft, Google, IBM, and you - and they build the products based on what the customer says he wants and what the Government says they must.

And no, you don’t have to buy one if you choose not to………

Unjust Enrichment

2011-03-20T13:28:00.000-05:00

A new lawsuit has been filed this month in an attempt to curtail the unconsented and currently legal traffic of de-identified medical records, this time against pharmacy giant Walgreen. The class action suit brought by Todd Murphy, a citizen of the State of California, on behalf of his children, is alleging that Walgreen’s sale of prescription histories to data mining companies, servicing the marketing efforts of pharmaceutical companies, is an unfair, unlawful and deceptive business practice allowing Walgreen Co. to unjustly enrich itself while depriving the rightful owners of the data of their ability to benefit from the commercial value of their prescription records. There is no mention of privacy violations anywhere in the brief, and this is what makes this legal action very unique and potentially a landmark in the effort to control unauthorized sales of medical records.

The deceptive business practices are pretty straight forward to understand, since it seems that Walgreen makes all customers sign a privacy notice stating unequivocally that Walgreen will not disclose patient information without first obtaining authorization from the patient. Furthermore California law prohibits pharmacists from disclosing prescription information to unauthorized third parties, which arguably makes the sale of data also unlawful. The bulk of the brief is describing the injury to plaintiffs caused by “detailing”, i.e. targeted in-person marketing by pharmaceutical reps to physicians, which is substantially aided by information extracted from plaintiffs prescription patterns. Detailing is portrayed as a ruthless drug company strategy to increase sales of newer and more expensive brand-name drugs, thus increasing the costs of health care, endangering patients and harming the doctor-patient relationship.

And here is where the complaint gets interesting. The plaintiffs are arguing that “As a direct and proximate result of Defendant’s unfair business practices related to the sale of Plaintiff and the Class’ prescriptions as outlined above, Plaintiff and the Class have suffered injury in fact, lost money and/or property by paying money to Walgreen to fill their prescriptions, and been deprived of the commercial value and business opportunity inherent in the contents of Plaintiff and the Class’ prescriptions.” First, tangible injury is (hopefully) established. Second, if prescription data indeed has monetary value, and according to Walgreen’s SEC filling it is worth about three quarters of a billion dollars, then that money really belongs to the plaintiffs, which are seeking “That Defendant pay restitution, damages and / or disgorgement as proven for Walgreen’s conversion of Plaintiff’s prescription, and/or for restitution of monies paid Walgreen for filling prescriptions, and/or profits to be disgorged as unjust enrichment, and/or for the amount found to be due from defendant to plaintiff as a result of the accounting and interest on that amount from and after filing suit.” If this action is successful, and it is established that medical data, whether identified or de-identified, is the property of the patient, and any proceeds from the sale of such data should flow back to the rightful owners, there will be very little incentive for Walgreen or any other medical records hosting entities to engage in wholesale of electronic health records.

The State of Vermont has a different opinion regarding data ownership. After a US Appeals Court ruled Vermont’s ban on the sale of prescription data unconstitutional on grounds of First Amendment violation, the US Supreme Court agreed to review the case. Vermont’s main concern is the sale of Prescriber Identifiable (PI) data and the ill effects of the resulting “detailing” on cost of care, physician privacy and doctor-patient relationship. Several “friend of the court” briefs filed in support of Vermont’s plea are also raising patient privacy issues and pointing out that de-identification, as performed by data-mining companies, is very likely reversible. Just like the recent Maine and New Hampshire laws, Vermont’s ban on prescription data sales to data-mining companies is enforced at the prescriber level (New Hampshire has a complete ban on sales, Maine allows prescribers to opt-out and Vermont proposes to allow doctors to opt-in). While both Maine and Vermont laws assign control of PI prescription data to physicians, neither one proposes actual ownership, including commercial value compensation, to anyone other than those collecting the data in the first place. New Hampshire’s total ban on sales for detailing purposes implies that the State is in control of the data and nullifies any commercial value associated with this type of activity.

While the US Supreme Court review of the Vermont case is most certainly welcome, I don’t believe it will settle the general questions surrounding ownership of medical records. Watching Murphy v. Walgreen Co. winding its way through the various courts, as it certainly will unless summarily dismissed in San Diego County, should provide better intelligence, particularly regarding a legally acceptable definition of injury which is paramount to the success of this lawsuit. Hopefully others will bring similar actions and expand the scope beyond just prescription data. Physicians in particular would be well advised to consider the unjust enrichment of technology companies packaging and selling medical records composed by physicians who are investing large sums of money in the technology itself and are experiencing revenue losses due to decline in productivity and other software mishaps, all under threat of regulatory government penalties in the very near future. If this does not qualify as injury in a court of law, I don’t know what would.

A Speed Bump on the Road to Meaningful Use

2011-03-14T14:39:00.000-05:00

Meaningful Use has hit a speed bump. It’s of the low, wide and gentle type, not the old raggedy, narrow and mean bump you find in older parking lots. Now that a tentative proposal for Meaningful Use Stage 2 has been published by ONC, and duly commented upon by the public, it just dawned on folks that there isn’t enough lead time between Stage 1 and Stage 2 to allow for an orderly transition, and here is the problem in a nutshell.

Meaningful Use is divided into three, increasingly more demanding, stages, starting in 2011 with Stage 1 and advancing every two years to a higher Stage. So 2013 marks the beginning of Stage2 and 2015 is the start of Stage 3. It seems that ONC and CMS need about a year and a half to define each Stage from start to finish, so if they start working on Stage 2 right after Stage 1 commences, there are only 6 months left for NIST to define certification criteria, EHR vendors to update their wares and certify them, and physician and hospitals to roll the new and improved products out. Oops……

The hand wringing in “industry experts’” circles began immediately after this realization, culminating with an Advisory Board publication advising hospitals in particular to not apply for Meaningful Use incentives in 2011, but instead wait for 2012, which they can do without penalty, and the same advice is applied to ambulatory practices owned by hospitals. They did not recommend anything for physicians in private practice. Since hospitals have a fiscal year starting on October 1st, three months before private practitioners, and Stage 2 Meaningful Use final ruling is not expected before the summer of 2012, it seems that hospitals are indeed at a greater disadvantage in that according to current regulation, providers must begin Meaningful Use reporting on the first day of their respective fiscal years. Stage 1, which was not finalized until late last summer, would have been a problem too, but the disaster was averted by CMS’s relaxation of requirements to only impose a 90 days Meaningful Use period in the first year, thus effectively pushing out the dreaded start date by up to 9 months. So should you wait for 2012? Before we shoot from the hip in panic, perhaps we should examine a few facts.

The tentative proposal for Stage 2 criteria as published by ONC contains very few new items. Most criteria are restricted to Stage 1 functionalities, but require clinicians to do more of the same. For example, if Stage 1 required that you record vital signs for 50% of patients, Stage 2 may require that you do that for 80%. This type of upping the ante does not require NIST to create new certification tests and does not require EHR vendors to write new software. Other Stage 1 criteria are not changed at all for Stage 2, and a few that used to be optional are now proposed to be mandatory. All these changes have no bearing on NIST, the vendors or the software. Let’s look then at the 10 “newish” requirements proposed for Stage 2.

Clinical Decision Support (CDS) rules must originate from a reputable source and be properly deployed – CDS was part of Stage 1 and the Stage 2 qualification should already be implemented in any EHR worth anything. This is a non-issue unless you bought one of those fly-by-night certified EHRs, in which case you have much bigger problems than missing out on stimulus incentives.
Advanced Directives recording is extended to physicians – This requirement was only for hospitals in Stage 1. Most decent EHRs already have this implemented and NIST has the test written.
Electronic Notes – For hospitals, they allow the notes to be created by NPs and PAs. This is brand new and ONC will need to define what constitutes a Note and NIST will need to create a new certification test, but if your software does not allow you to document a visit note, you probably don’t use an EHR anyway.
Track Meds in the eMAR – Is any hospital that is ready for Meaningful Use in 2011 not doing that already? Anyway, NIST will have some work to do here.
Patient Portal – For Stage 2 there are several requirements that make having a Portal absolutely necessary. Most EHR vendors used their portals to certify for Stage 1, so again, not much work here for vendors, although NIST may have to tweak some tests. An interesting tidbit is that the Stage 2 proposals envision requiring physicians to make sure that 20% of their patients use the Portal. Not sure if I should laugh or cry, but I cannot see this particular requirement withstanding the rigors of a final ruling.
Record Patient Communication Preferences – All but the quackiest EHRs already have this simple functionality. NIST will have to write a simple test.
Care Team Members for each patient – Seriously? Anyway, this is insanely simple to do and simple to test.
Longitudinal Care Plans - ONC is still trying to define what this means, but if everything evolves as it did in Stage 1, it will probably boil down to something like prescribing statins, or having a standing order for HbA1c every 3 months. No work for vendors and very little work for NIST.
Health Information Exchange – This was required to be tested in Stage 1 and now it is required to establish actual connections. Nobody said anything about using those connections. I cannot imagine that this requirement will survive as written, but it should not require much effort from certified vendors and very little adjustments from NIST.
Clinical Quality Measures (CQM) – The ONC proposal had no specifics here, but it stands to reason that they will be adding more measures in Stage 2. CQM has been the Meaningful Use Trojan Horse all along, so it will continue to be so. Unless tempered by reason, the new CQMs will require some doing from all stakeholders.

Contrary to the Advisory Board opinion, Stage 2 is nothing but an incremental change to Stage 1. Just like vendors did not sit idle while CMS and ONC were grinding the Stage 1 sausage, they will not be taken by surprise when the final Stage 2 rule is published either. However, even if enough vendors certify in time for the October 1st 2012 deadline, there is no way hospitals can be ready to move to Stage 2 on the appointed date, and very little chance that ambulatory offices will be ready to rock-and-roll by January 1st 2013.

The Meaningful Use workgroup at ONC held a meeting on March 8 and this very issue was raised. Surprisingly all participants calmly concluded that there are several possible solutions and one will be picked after proper consideration. Here are some of the options and my take on all of them.

Push Stage 2 by one year closer to Stage 3 – Not a very good option for dealing with Stage 3 when the time comes, since the 2015 date is locked into statute and cannot be pushed.
Allow folks to continue reporting on Stage 1 for the first 9 months of the 2013 fiscal year and begin Stage 2 reporting in the last 90 days of 2013 – This is reasonable, but a very complex structure for CMS to accommodate.
Require only 90 days reporting for the first year of Stage 2, just like we did for Stage 1 – Simple, straightforward and my personal favorite.

Either way, hospitals and physicians should feel comfortable that an equitable solution will be forthcoming and there is nothing to be gained from postponing your 2011 attestation if, and only if, you are ready to go. ONC has shown time and again that it has an obvious interest in having as many certified vendors and as many Meaningful Users as possible, by consistently lowering the bar on problematic requirements. There is no reason to assume that ONC will refrain from doing so now. I may add that a bird in hand is worth two in the bush, and nobody knows what will happen to these incentives in 2012, which is an election year, and beyond.

Liquid Vapor

2011-02-27T18:52:00.000-06:00

For the uninitiated, every year HIMSS runs this big huge trade show for EHR and HIT vendors, which is to the HIT industry what Oscar night is to Hollywood. No, HIMSS does not award any prizes or trophies, but it occasions the same breath taking congregation of all industry glitterati in one place, complete with clever little parties and big extravagant shows. There were well over 30,000 people at this year’s HIMSS11 conference, and although I wasn’t one of them, I made sure to follow the events through the steady Twitter stream and many excellent blogs, reports and interviews, because what happens at HIMSS is good indication for what the HIT industry is doing and where it is going. So to summarize all the excitement, the established HIT folks are doing Meaningful Use, which has become yesterday’s news, with HIE being the next project on the books. Everything is being pushed to tablets and the cutting edge innovations are all about a myriad of small Mobile Health (mHealth) applications. Analytics and business intelligence is looming large on a horizon filled with provider consolidation, capitation and value-based medicine.

On the surface, this seems a very logical succession of events. Meaningful Use is collecting data, HIE will make it liquid and, as predicted, 1000 flowers of innovative mobile applications will eventually be blooming to bring the liquid data to consumers and innovators who will slice and dice it to provide us all with unimaginable medical utility. However, in the excitement of anticipation on those balmy Florida nights, it is easy to overlook the fact that this entire chain of events is based on one assumption: somewhere, somehow, someone will have to enter data into the system, consistently, accurately and in minute detail. For free. Is there a problem here?

Well, it depends on who you ask. The Meaningful Use regulators, encouraged by the stated intentions of many physicians and hospitals to seek Meaningful Use incentives, are probably assuming that data will be dutifully entered into HIT systems. HIT vendors seem even more certain in their assumption that data will accumulate in their systems, since very few, if any, are doing anything about data entry user interfaces. The same forms and templates sold four, five years ago remain unchanged in the Meaningful Use certified, and iPad enabled EHR versions of today. If you ask physicians and nurses, they will invariably tell you that they resent being turned into “data entry” clerks. And, yes, unlike other industries where computerization of records seemed to have worked wonders, in health care data entry must be done by the scarcest and most expensive resource in the system. Some of those expensive resources decided to do what highly paid executives have done decades ago: hire a stenographer, or in health care parlance, a scribe; interesting idea, but a partial solution at best, and a new source of errors and inaccuracy, at worst. So, how is it that 41% of physicians and 81% of hospitals believe that they can achieve Meaningful Use, which comes with rather prescriptive data collection requirements?

One answer would be that doctors and nurses everywhere are just fine with clicking on as many boxes as needed to qualify for government incentive funds. Clicking 4 Dollars may turn out to be a successful strategy. Another possibility would be that data collection requirements embedded in Meaningful Use are not so obvious to the naked eye. The place to look is the long list of Clinical Quality Measures. For example, a simple measure such as Adult Weight Screening and Follow-Up (NQF 0421), has the following description: “Percentage of patients aged 18 years and older with a calculated BMI in the past six months or during the current visit documented in the medical record AND if the most recent BMI is outside parameters, a follow-up plan is documented.” Sounds simple; the nurse weights everybody anyway, and the EHR calculates BMI on the fly, so no problems here. Or are there?

What is the meaning of “a follow-up plan is documented”? Does it mean that you type into the Plan section something like: “recommend 30 minutes walks every day and low fat diet”? Eh, not good enough. First the EHR needs structured data fields to perform calculations and your free text is unusable. Second, this is not a follow-up plan. A follow up plan would involve gastric surgery, referral to dietician, referral to exercise classes or at the very least a V65.3 added to a visit. All the sanctioned CPTs for these activities are provided by NQF (not sure how they end up in your chart though). Just a few more clicks, but we’re not done yet. Like most measures, this one has exclusion criteria, i.e. patients for whom you need not document a follow-up plan. So if you don’t document one, you must specify the reason. Did the patient refuse to discuss such plan, or was there a medical reason not to have a plan, or perhaps the patient suffers from a terminal illness? Need a couple more clicks here to complete this one measure. Does your certified EHR have all those boxes for you to click on?

This was one of the simpler quality measures. If you are interested in hospitals, you may want to look at this CSC report which uses VTE prophylaxis as an example of the mind numbing complexity of data elements required for accurate reporting. As far as Meaningful Use is concerned, if you don’t collect all data elements and your quality measures numbers are less than stellar, there is no harm done. The incentives are not dependent on perceived quality. However, if you’re a physician, maybe not today, maybe not tomorrow, but soon, your paycheck will be dependent on little else. And whether you are an EHR vendor, an HIE vendor, a data analytics middleman or a brand new mHealth vendor, your financial success will be inextricably tied to the amount and accuracy of data entered by clinicians at the point of care. You cannot make liquid that which does not exist.

Solutions? We could continue to apply pressure to practicing clinicians in the hope that the vapors will condense into droplets of liquid data. We could also look for objective liquid data somewhere else, but for some reason I am starting to think that those who want data, are more interested in patient and physician generated data, perhaps because of its inherent richness of intimate details. We could also create EHRs which will allow one-click documentation-by-exception of “normal” quality measure elements, similar to what we did for CMS reimbursement required data elements, and with similar results, i.e. 12 pages of irrelevant visit notes (Bingo!!). Or we could look for true innovation in human computer interaction which will make data collection a transparent byproduct of the practice of medicine. Until then, all the Internet pipes and all the tagged and untagged content flowing through them and all the master patient repositories and all massive provider directories will provide only incrementally better clinical utility than electronic faxing.

How to Meaningfully Shop for an EHR – Part III

2011-02-20T18:46:00.000-06:00

(Seal the Deal)

We have arrived at the point of no return. You are now looking at an EHR vendor contract and no matter how well you negotiate this contract, once signed, it will be very difficult for you to change your mind and “get out” without incurring large financial penalties. Once you begin using the product, there will be more than just financial considerations barring you from switching to a different product, and the longer you use the EHR, the harder it will be to replace it. Even if you did a stellar due diligence as outlined in Part I and Part II of this series, there is still a significant chance that you selected an EHR that will not work very well for your practice, a company that will go out of business or be acquired, or a product that will be left behind as new vendors enter the market with new and innovative technologies. Does this mean that you should forget the whole thing and not buy an EHR? Not necessarily. In a free-market economy, these risks are always present, whether you are shopping for an EHR, a car, cable TV, phone service or anything else. Your job as a consumer is to minimize your risks, but understand that you cannot completely eliminate risk in general.

First you need to understand exactly what you are buying. Much has been said about the difference between buying an EHR, through a license model, as opposed to buying the services of an EHR, through a Software-as-a-Service (SaaS) model. Is there a difference? Is one safer or cheaper than the other? To answer these questions, one must first understand the obvious: EHR is a software program which can only exist when installed on a piece of hardware. Whether the EHR exists on a computer under your reception desk, or in a datacenter over the rainbow, or in some nebulous Amazon Cloud, EHR is still a piece of software, made of many lines of code instructing the computer to perform certain actions at certain times. Wherever the EHR software resides, it will need a physical computer, electricity, ventilation, internet connectivity, lots of cables and other peripheral physical devices. And, yes, “virtual servers” also need computers to execute on. All those trendy clouds are nothing more than giant warehouses full of metal and plastic machines connected to the local electric company and the Internet through lots of colorful plastic cables, and the Internet itself is made of gazillions of similar machines, connected together through routers and switches and ocean floor cables and satellites.

So what are you buying when you buy an EHR? Simply put, you are buying the right to use the software. If you are buying your EHR through a SaaS, or Application Service Provider (ASP), model, you are also buying the rights to use the machines on which the EHR software resides. If you are buying your EHR via a license model, it is up to you to provide the plastic and metal and cables that house your EHR software, and all the additional services it needs to operate. You do not own the EHR software any more than you own Casablanca after you purchase the DVD – you can watch Ingrid as much as you want, but you cannot replace her with Beyoncé and you cannot prevent her from getting on that airplane. Not much different than “pay-per-view” or Netflix, other than the fact that if you “own” the DVD, you can cut it up in a million pieces, if you so choose. Now that you understand what you are about to spend money on, let’s see what can be done to obtain the most advantageous terms from the seller.

Standard Terms & Conditions
The following concepts are not unique to EHR contracts. They are the same concepts that you will find in a contract with the guy that is remodeling your kitchen, or an extended warranty on your new surround sound system, but their application is specific to the contracted service.

Contract Period – You would think that if you went to great pains to identify a good product, you would want to lock the vendor into a long term commitment, but if you sign a contract for 50 years (yes, they do exist), it also means that you are locked in for the same period of time. Considering the opening statements to this article, this may not be the best course of action. To get the best of both worlds, you should strive for the shortest possible contract (12 months), with an option to automatically renew the contract every year at your sole discretion. The vendor will want to obtain the longest possible contract period. Most start with a 5 year period, which is an eternity in the software world, and an acceptable outcome of negotiations would be 2 to 3 years initial period with automatic renewal for the same. If you can get a 1 year renewable contract, consider yourself lucky.
Price – A contract is also an itemized bill of sale outlining the products and services you receive, their individual pricing and a grand total. The contract should itemize all services and sub-parts required to provide you a complete service. Just like you would not buy a car that lists Tires as a third-party option that you need to buy on your own, you should not accept a contract that lists Claim Clearinghouse as an unquoted third-party option that you need to separately negotiate and obtain. The contract should also be very specific as to what an item includes. For example, $5000 for training is meaningless unless it specifies the number of hours, the means of delivery and the qualifications of the trainer(s). Similarly, you should avoid open-ended pricing on a time-and-materials basis, which is usually offered for custom interface and data migration work. Insist on a fixed price, and at the very least a “not to exceed” number. Every contract will include a clause allowing the vendor to increase price on an annual basis by at least the Consumer Price Index (CPI) percentage growth. Anything undefined in that clause, or above 5% is highway robbery. Based on the contract pricing, you should be able to easily calculate three indicators: 1st year cost, 2nd year cost (should be much lower than 1st) and 5 years Total Cost of Ownership (TCO). If you cannot calculate these three numbers, return the contract and ask for clarifications.
Schedule – A good contract should include vendor commitment to an implementation schedule, including go-live dates for the EHR and any interfaces you are purchasing. Considering that vendors are extremely busy and spread very thin in this HITECH era, you should insist on an enforceable commitment to implement your EHR within an agreed upon period of time, subject to significant financial penalties or breach of contract. The vendor will most likely insist on adding language committing you to meet your obligations necessary for a timely go-live, and this is fair.
Workers – You would be hard pressed to find an EHR contract specifying any minimum requirements for vendor staff delivering services to you, and yet many implementations fail because vendor staff is unqualified to deliver these services. Right now there is a terrible shortage of qualified HIT resources and the temptation to cut corners is very real. You should insist on adding a clause guaranteeing that your trainers and implementers have a minimum of 3 years EHR implementation experience, at least 1 year with the current company, and carve out your right to review resumes, interview and dismiss any vendor staff assigned to your practice with no adjustments to the contracted schedule.
Materials – The equivalent of materials in the EHR world is the content of your training and implementation. A contract should include a detailed project plan for your implementation and an itemized curriculum (including hours and delivery method) for your training. These documents should be incorporated in the contract as exhibits, not just provided to you independently for review. In addition, a list of minimum hardware requirements should also be an exhibit in your contract. You don’t want to find out after the contract is signed that you need to rip and replace every computer in your practice and pay for a dedicated T1 line to your office.
Warranties/Service Level Agreements (SLA) – If you go back and recall that EHRs are software programs, you should understand that no software vendor can, or will, warranty that the software is free of defects or that it will operate continuously 100% of the time, not even Microsoft or Apple or even IBM. Here you should be looking for SLAs. There should be 3 or 4 severity levels of problems defined (complete shutdown, severely impaired with no workaround, workaround available, minor malfunction) with a predefined response time, a predefined resolution time and clear financial penalties for not meeting the SLAs. It is very important that you stick to your guns here, since the SLAs are defining the level of support you will receive down the road and a vendor that recoils from commitment here probably has a very good reason to do so.
Regulatory Compliance – The only current regulations pertinent to EHRs, are HIPAA and Meaningful Use. Most contracts have the HIPAA commitment built in and various commitments for Meaningful Use, ranging from lip service to full money back guarantees. Read carefully and remember that Meaningful Use is only the beginning. There will be Meaningful Use Stages 2 and 3 and it is possible that somewhere down the line the FDA may want to oversee EHRs. Ideally, you would want a commitment to adhere to Federal and State regulations and a separate commitment to adhere to all Meaningful Use specifications (quote the statute) as updated by the Secretary of Health and Human services from time to time.

EHR Specific Terms & Conditions

Data – Almost every EHR contract contains a glorious statement, meant to make you feel good, that all data in the EHR belongs to you. This statement is meaningless. To obtain tangible protection you need to have two additional clauses in the contract. One is a “not to exceed” price for all data extraction, including clinical, from the EHR in a standard format (CCD, HL7, CSV and PDF), with specific standards attached to specific data (CCD for clinical data, HL7 for demographics and insurance, CSV for all other structured data and PDF for all documents). Other than a fixed price, you should also insist on a “not to exceed” timeframe for completing the export and a commitment to work with your next EHR vendor. The second clause, which is generally ignored and most often with disastrous consequences, is a requirement that in case of a dispute with the vendor, you should be allowed full access to viewing the EHR until the dispute is resolved. Vendors have been known to cut access to the software for non-payment and any other breach of contract. You need to avoid this possibility. If you are contracting with a rather new or small vendor, you will be well advised to contractually commit the vendor to provide you with weekly full data dumps, in the above formats, that you can keep in your office. Do not accept copies of backups, unless you have a tested way to restore a full working database, and overwhelmingly you will not. Be advised that almost all EHR vendors will be monetizing your patient “de-identified” data in accordance with HIPAA restrictions. You may want to try and limit disclosure, request that physician data is also “de-identified” or request notification of secondary use of your data. Most likely, you will make no headway here.
Hold Harmless - The infamous “Hold Harmless” clause that is supposed to shield vendors from any responsibility of harm to patients, is rarely present in ambulatory contracts. The lunatic fringe’s loud screams notwithstanding, most contracts only contain statements of vendor’s limited liability (usually 1 year worth of maintenance) for all damages to the business, including financial losses and malpractice judgments, arising from use of the product. Just like you cannot sue Microsoft if the lack of usability in Excel caused you financial loss and you cannot sue Intuit if a bug in TurboTax prevented you from filing on time (happened to me), you will not be able to seek financial compensation from an EHR vendor commensurate with your damages. The best you can do here is try to get the vendor to agree to increased liability (perhaps double the original), but you can be certain that any liability will remain limited.

Most important, whatever you do, please seek legal advice for this step. The above points are very general in nature and not comprehensive enough for you to adequately navigate the contract on your own. Remember that vendors have large legal departments and by forgoing legal advice you are placing yourself at significant disadvantage. Small practices often do not heed this advice, but large medical groups always use attorneys for contract negotiations. Call a colleague who works for a large group and get a referral to an attorney that is experienced in EHR contracts. It may end up costing you a couple thousand dollars, but considering that you are about to enter a contract worth upwards of $50,000 for each licensed provider over the next 5 years, and considering the ramifications to your business if you sign the wrong contract, the attorney fees are money well spent.
Good luck and happy hunting!

How to Meaningfully Shop for an EHR – Part II

2011-02-13T15:32:00.000-06:00

(Research and Observation)

Here we are going to talk about the second stage of shopping for an EHR. We are going to assume that you did your homework, defined your goals and constraints and prepared a comprehensive list of requirements for an EHR (if you have not done so already, go back and read Part I). To continue our car shopping analogy, we are now ready to go kick some tires, and we start by calling on each of the three to six EHR vendors on your list. To your folder of lists, add a blank page for each vendor, to log your interactions with the various representatives you will begin encountering shortly. If the sales person is unresponsive and if it takes weeks to have someone call you back, most likely the situation will only deteriorate after they get a hold of your money, so keep good notes.

Calling an EHR Vendor
Whether you start by filling out a form on a website or by sending an email, eventually you will be on the phone with a sales rep. You should be the one directing the conversation. Inform the sales person of your specialty and practice size and explain that you are conducting an EHR search and his company is one of your candidates. Do not disclose the remainder of your list unless you are interested in a “confidential” long lecture on how horrible the competition really is. Your goal here is to obtain contact information (phone and email) of the regional sales executive, inform him/her that you will be sending out a Request for Information (see below) and set a date for your first clinical demonstration of the product. You can listen patiently, if you wish, to the details of this month’s “special offer”, but stick to your agenda and commit to nothing other than a demo. Remember to log your impression from this call, including the vendor’s willingness to accommodate your schedule and the expediency of setting up a demo date.

Request for Information (RFI)
All cars on a dealer lot have stickers on the window that describe the engine size, the trim, the optional packages, the gas/mileage performance, etc. When you look at an EHR vendor website, you will learn that the EHR has a scheduler, a documentation module, eRx, practice management, etc. In car parlance, it would be like saying that the car has an engine, a steering wheel, tires and seats. Not good enough. The role of the RFI is to extract the specifications of the EHR. Vendors are used to filling RFIs for large systems, but almost never from a small practice. It is high time to change that. A basic RFI should include the following questions at the very least:

Company information – Years in business, number and location of employees by role, financial information, history of mergers and acquisitions, number of physicians employed
Customer base – Number of installed practices by size, number of physician customers (not users in general), number of installed practices in your state, number of installed practices in your specialty, number of new practices installed in the last 12 months and a list of 5 references you can call, preferably in your area
Training and Support policy – Standard support hours and cost, extended support hours and additional fees, type of support (phone, pager, email), response times and penalties, standard training package and cost for additional training, waiting time for new implementations and pricing for all standard and extended items
Product – Deployment model (full license or subscription, locally or remotely hosted), frequency of upgrades, required hardware, required broadband and network, required third party software, optional modules, warranties and prices for everything
Features/Functionality – You could go and list 20 pages of features and functions here, but you would be wasting your time and the vendor’s time. If you stuck to the advice in Part I, then your short list of vendors is towards the better end of the spectrum and has been CCHIT 2011 certified, which means all the nuts and bolts are there. Whether these nuts and bolts are optimally assembled is a different question and one not answered by an RFI. So here, stick to your list of requirements and only ask about features that are important to you.
Trial Version – I am listing this separately because it is very important and a good quality indicator if the vendor is willing to grant you access to a trial version of the software, or a vendor hosted “sandbox” where you can test drive the product on your own. Always ask for this, but know that, unfortunately, very few vendors will allow it.
Due Date - Clearly specify the date by which you want the vendor to respond. Two weeks is an adequate timeframe.

Your RFI should run about 5 pages long at the most and you will have to read the response and devise a way to score it, sum it up and compare across vendors.

Product Demonstrations
In parallel with your RFIs, you should schedule at least 3 separate demos. Insist that your staff and partners, if any, are in attendance. All demos can, and should, be done over the Web at your convenience (lunch hour, early morning or after hours).

Clinical Demo 1 – For this introductory demo allow the vendor to perform its standard canned demo, restricted to the EHR portion only. Do not confuse this with one of those public webinars that you can sign up for online. This demo should be scheduled and performed exclusively for your practice. You should allow the demonstrator to do “his/her thing” and present the product in the best possible light. If you don’t like what you see, be sure that it will never look or perform better and scratch this particular vendor right here. If all goes well, find a good time in the demo, towards the last third, and create a bit of unexpected action. For example, suggest that the diabetic patient being demonstrated brings up a lump under the left arm right before she leaves (by-the-way), or suggest that you want to prescribe a medication that you know has been discontinued, or recalled (nothing as obvious as Vioxx), or maybe mom wants the doctor to also look at little Tommy’s rash while she is here. Plan ahead and be creative. The purpose here is not to embarrass the vendor, but to see how the product deals with the less beaten path, which is of course the norm in your daily work.
Clinical Demo 2 – Before you schedule this one, you need to create two or three scripts that are most common in your specialty and are not trivial in complexity. For example for a family doc, a good combination would be a diabetes-hypertension-obesity-depression visit with new symptoms, a catch-up immunizations pediatric visit and a third trimester OB visit with some complications and risk factors. You can use your actual charts to create the visit script, including assessment and plan, and it should not exceed 2 pages per visit. Send these scripts to the vendor ahead of time and ask that the demo should follow your script exactly as written.
Administrative Demo 3 – Allow your office manager and biller a full demo hour, particularly if you do billing in-house. Your staff should come up with a list of items they want to see, but vendors usually have pretty comprehensive practice management demos. Encourage your staff to ask plenty of questions and make sure the vendors show the functionality, not just state that it is there.

While these demos are being coordinated and performed, make sure you update your log regarding vendor responsiveness. Have everybody in your office score all demos from all vendors and add these scores to the RFI scores. I know it sounds like hard work, and it is, but an EHR is an important purchase and deserves your full attention.

Reference Checks
If all goes well, the vendor should have supplied you with contact information for several practices you can call, and you should call them all, speak to at least one physician and have your office manager and biller call their counterparts at those practices. But here is the rub; you should know that those are pre-screened favorable references. No vendor would volunteer a slate of unhappy customers. If you know colleagues that use the same EHR call them too. If you don’t, try calling your local Regional Extension Center (REC) and ask about practices that may be using the same EHR you are considering. It may take a bit of persuasion, but RECs should be able to deliver. If all else fails consider posting a question to one of your physician forums.
What should you ask during a reference call? You should make a checklist in advance that includes your goals and constraints and try to figure out how the reference practice is performing against your criteria. For the sample goals and constraints outlined in Part I, you would ask the following:

How are you doing with Meaningful Use? Do you expect to get your stimulus check any time soon?
Are you completely paperless? Do you want to be paperless? Are you getting lab results electronically? Is your phone call volume lower? Were you able to reduce payroll? Did you have to hire IT guys?
Is your reimbursement higher now? Are collection rates better? Do you see more patients? Any bonuses from HMOs?
Do you have more time with patients? Are disease management tools helping? Are patients satisfied? Is your staff happy?
Was it worth the expense? Would you do it again? Would you do certain things differently? Would you recommend I do it?
How long did the implementation take? Was the vendor helpful?
Can you customize templates and workflows? Did you have to change how you do business? Is it working out for you?

Listen carefully, score all calls and add to your growing body of evidence.

Site Visit(s)
At this stage in your shopping journey, you should have been able to eliminate all but two or three EHRs. If you didn’t, then now is the time to pick the top contenders and prepare to go see them in action. Logistically, this the most difficult task to accomplish, particularly for a small practice and particularly if you practice in a remote or rural area. After a long and arduous research, you will be tempted to skip this part. Don’t. This is the only opportunity for you to see if everything you were told is actually translatable to real life situations. Remember that vendors sell EHRs all day, every day and they have acquired certain mastery in presenting the product in the best possible light. It is never as good as it sounds, and you need to find out if it is good enough for you. Yes, you may need to close your office for a day or at least take part of the day off, but a wrong EHR choice could cost you tens of thousands of dollars in lost productivity, so this is a wise investment.

As with reference checking, you should have a checklist of what you want to ask and see, and you should take at least two or three members of your team with you on this “field trip”. Tactically divide the observation into three parts:

Front Office – Watch an entire check-in process, an appointment being made and the triage of incoming phone calls
Back Office – Watch the biller work and ask questions here and there. Make sure that you ask about coding, claim submission and follow-up, payment posting and patient accounts
Clinical – You have to be able to be in the exam room with more than one physician and watch them review, document and order. Don’t forget the nurse, particularly if she/he is the one doing most of the ordering.

In all cases make sure you stand behind the person interacting with the EHR, so you can see the screen. Pay attention to their body language, the number of failed attempts to accomplish a task, computer sudden crashes (if any), time it takes to move from screen to screen, number of steps to complete a task and the general attitude of the user you are observing. If you are visiting a larger practice, try to locate a physician that was not part of the EHR selection committee and shadow him/her. It’s OK to carry a clipboard with your checklist around and make notes as you go. Try to find some time for casual conversation with the doctors at this practice. It would be perfect if you can take your host out to lunch, but the break room should be fine too. On the way back compare notes with your team members and make sure every little thing is documented while memories are fresh.

You now have all the information needed to make your decision. It is best practice to have a staff meeting and review your documentation and your scores for each vendor. If you are lucky, you will have a clear winner. If you are like most, you will be debating between two or three EHRs that seem equally acceptable. There is also a distinct possibility that you came up empty handed and nothing you saw looks like the optimal solution for you, in which case you should file your information in a safe place and wait for a better day and a better product and know that this was not an entirely futile exercise. One of these days, you will want to revisit the EHR concept and what you learned from this process will come in very handy.

If you have selected one or two products, it is time to contact the vendors and ask for a contract. Not a sample blank contract, but a signature ready contract, made for your practice with all the pricing information filled in. In Part III of this series, we will look at the last hurdle in your EHR search – obtaining a most advantageous contract.

How to Meaningfully Shop for an EHR – Part I

2011-02-10T12:55:00.000-06:00

So you’ve been hearing all about the recent EHR buzz and decided to give it a try. Whether you are convinced that electronic records are the way to go, or you have reached a point where you are willing to give it a try, the first thing to do is buy one of those EHRs. You may be staring at a glossy brochure or website featuring a distinguished silver-haired doctor holding a cool little tablet computer and smiling reassuringly at the little old lady sitting comfortably in front of him, with a large 1-800 number on the bottom urging you to call now. Don’t.

Shopping for an EHR may be more complicated, but is not much different in nature than shopping for a car or a new type of breakfast cereal. Of course, you have been shopping for cereal since you were a toddler and probably bought your first car as a teenager, so the entire shopping process is almost second nature. Not so with an EHR. Just like cars and cereal boxes, there are hundreds of EHR products out there, and just like cars and cereals, you need not bother with most, and after you narrow the field down to three or four, it makes little difference which one you end up taking home. The qualitative roadmap below will lead you to those three or four obvious choices of EHRs best suited to your particular situation. The final choice is yours to make.

Goals
The first thing you need to do is to honestly list why you want to invest in an EHR. Listing goals has two purposes, one is to help guide your selection and the other is to retrospectively assess your success or lack thereof. The more specific and measurable your goals are, the better they will serve you. Let’s look at some examples.

I want to receive the $44,000 stimulus money from CMS – This is a very precise goal and can be easily measured over the next 5 years. This goal also exemplifies the need to have enough information before you set a goal. You need to know that the amount of incentives is not fixed. Instead it depends on your patient mix, your charges, your ability to meet complex requirements, the date you start using your EHR and even the next election. You also need to know that these incentives are fully taxable.
I want to improve my practice’s efficiency – I’m sure that here you are envisioning getting rid of paper charts, automating billing, having lab results and other paper artifacts come in electronically, reduce phone calls, increase number of visits and maybe reduce payroll a little. The right EHR, correctly implemented and correctly utilized can help with many of these goals, but not all. Here we consider the fact that your goals must be realistic. Expecting to be able to see more patients with an EHR is not realistic and probably the opposite is true. Reducing payroll is also not a very likely outcome, since for every medical records person you may be able to let go, you would have to hire an “IT guy”, and if you are a small or solo practice, there is no one to fire anyway. Nevertheless, break this goal down into various efficiencies and quantify your expectations.
I want to increase reimbursement levels – This is a very doable goal. The point here is that if you want to be able to measure success, you should set a better defined goal. Are you referring to being able to safely code to a more appropriate level? If so what is your desired improvement? 10%? 20%? Are you referring to ability to participate in an Accountable Care Organization? Are you intent on obtaining performance bonuses from insurers or an HMO? Perhaps all of the above. Just make sure you list them with as much specificity as possible.
I want to improve patient care – That’s a great goal, but needs a lot of definition work. You may want to be able to spend more time with each patient, or you may write down that you want to improve the standard of care for all your diabetics, or perhaps you want to make sure that all the kids in your care get all their immunizations on schedule. There are too many options to list and they will depend on your specialty, the characteristics of your patient panel and your professional views on the practice of medicine. Try to be very specific here as well.

These goals are just the most common examples. I am certain that you will come up with many more and you should consult with everybody else in your practice as to their goals as well. As mentioned above, and very similar to car shopping, during the next few months, you will inevitably find out that some goals are unattainable and others will need to be sacrificed due to constraints.

Constraints
If you had all the money in the world and no kids or dogs, you would probably drive something different than what you drive today. You knew your limitations when you went looking for a car and you should know them when searching for an EHR.

I don’t want to spend a fortune – This is the most common and most important constraint, but it does need a bit more detail. Do you want to make a capital investment now and pay less in the future, or do you want to get an EHR with no money down and pay a monthly fee? How much can you afford to pay upfront? Do you want to go into debt and take out a loan? What can you comfortably pay every month? What are the tax advantages of each approach? Would you compromise and drive the standard company car if it was free (read: the EHR the hospital is giving away)? Lots of decisions to be made here, but establishing a budget and sticking to it will protect you down the road.
I don’t want to deal with IT – If this is one of your personal constraints, it will narrow down the field in a hurry to only those EHRs that can be remotely hosted by the vendor or one of its business partners.
I want my data in my office – This is the flip side of the constraint above and will similarly remove quite a few EHRs that insist on “hosting” your data.
My partner refuses to use a computer – You will need an EHR that can accommodate both of you and a vendor that is willing to be understanding and work with you.
I want to install the EHR before flu season – Sounds simple, but you will find that accommodating your timelines may not be so easy when everybody is out there buying EHRs.

This list will get very long. Talk to everybody in your office and let the list grow. Your billers in particular may bring up goals and constraints that you would have never considered. The next step is to take all those goals and constraints and translate them into requirements for your EHR. To continue the car analogy, if your goal was that all three kids and the large dog fit comfortably in the back seat, then the requirement is that the car has room for at least 5 passengers in the back, which will then narrow down your choices to an SUV or minivan. Combine that with your budget of no more than $30,000 and a constraint that you only buy American, and you have arrived at your handful of car choices. Let’s look at a sample list of requirements for an EHR for a solo primary care practice in a remote rural area. You should come up with your own specific requirements.

Non-Functional Requirements
As the name suggests, these are general requirements which do not pertain to actual software functions.

No money down and no more than $500 per month for the whole thing
Ability to function with or without internet connectivity
Maximum 3 seconds for screens to load
Support dictation and hand-writing
Ability to access records from nursing home, hospital and home
All data and records, or a current copy, physically stored in my office.
Ability for multiple users to access charts simultaneously
Certified for stimulus incentives
Money back guarantees if not satisfied

Functional requirements
These are specific requirements for specific functions in the software. Most will be derived from your goals.

All 25 Meaningful Use requirements fully implemented
Coding advice in workflow and automatic E&M calculation
Automated claim creation, submission and electronic remittance
Ability to verify eligibility in real time
Connectivity to the hospital down the street to receive lab results
Longitudinal customizable flowsheets
Integrated Peds dose calculator
Good selection of customizable documentation templates
Ability to customize pick-lists for diagnoses, medications, diagnostic orders
Ability to create reminders for chronic disease management

Now that you have pages and pages of all sorts of lists, is it time to call that 1-800 number from the glossy add? Not yet. If you were shopping for a car, you could of course stop by the first dealer you see and have him educate you on your choices of minivans and SUVs. A smart shopper would first consult something like Consumer Reports or JDPower, talk to friends and family and if you are like me, look at cars on the highway and every parking lot you happen to find yourself in. Alas, there is no Consumer Reports for EHRs. If you search the web for advice, you will come across a bewildering array of “free” advice sites, most of them requiring that you “register” before obtaining any help. Although it is usually very hard to tell, virtually all of them are there to lure you into buying something, be it EHR software, or services, or unrelated products and sometimes they are just collecting addresses for marketing purposes. Stay away from anything you are not already registered with by virtue of being a practicing physician. But there are some respectable ways to get good advice too.

Colleagues - The best sources for collecting names of EHRs that you should consider (or rule out immediately) are your colleagues. Seek out physicians that are using EHRs and ask for information. Most will be eager to share stories and give you advice. If you subscribe to a specialty listserv, or forum, you could find good information there too. For these, make sure you know the person presuming to give you advice. Sometimes you can learn a lot by just following conversation threads. You should be able to come up with a couple of good prospects and a couple of names to stay away from.

Medical Associations – The AAFP for example has a great EHR survey they publish every year. It is completely untainted by any vendor involvement. You have to be a member to access the results and they are mostly geared to family practice and general Internal Medicine, but pertinent to most physicians. The most recent results are from 2009 and 2010 is due out soon. Find a way to get to that survey. Other specialty associations have their own surveys. They should also have good resources and articles to help you with the process. Some have partnerships with certain vendors. Do not assume that those vendors are necessarily better than others.

CCHIT – CCHIT is now one of three EHR certifiers, but their private certification is still the Cadillac of the industry. Unlike the government certification, which is pretty bare bones, CCHIT certifies for a multitude of functionalities and for several specialties, such as Cardiology, Pediatrics, Dermatology and Behavioral Health. Their website allows you to play with different Non-Functional Requirements to narrow the field down, and CCHIT is vendor neutral, so try it out and look for vendors that voluntarily committed to keeping up their comprehensive CCHIT certification (latest level is 2011).

Regional Extension Centers (REC) – Every state has one and it is funded by the government for the specific purpose of helping you out. If you are a primary care physician, you may be able to get some free consulting, but in any case you should be able to get some good information and a list of EHRs the REC selected. Those EHRs may, or may not work for you, but this is another data point in your research.

Remember to update and augment your original lists as you learn new things. When you aggregate all the information you now have, you will discover that you have in hand a list of about three to six EHR vendors that you are ready to contact and check out. If that glossy add with the 1-800 number is from one of them, then by all means go ahead and call now. Otherwise, toss it and never look back.

In part II, we’ll kick some tires, look under the hood and go for a test drive.

Nothing but Questions

2011-02-07T02:01:00.000-06:00

Dr. Atul Gawande wrote an article in the New Yorker a couple of weeks ago. It’s a real story about real people, in real trouble, and the real doctors who choose to really care for them. And from this story we can draw a real lesson for a real solution to the real health care problem we are facing.
Unlike Dr. Gawande’s previous articles which fit nicely into policy, this one doesn't seem to generate nearly as much "buzz". Why is that?

Is it because the implication that if you want to save money in the long run, you need to go back to basics and actually take care of people on a basic human level?
Is it because this is too much hard work with no instant gratification from high-tech silver bullets?
Is it because we don't really want to put the patient at the absolute center of our efforts and would prefer to use representative data about the patient instead?
Is it because we prefer academic theory to execution, particularly when execution involves poor, dirty, drunken, sick people that need to be physically touched?
Is it because this flies in the face of both "personal responsibility" advocates and "get rid of mom and pop medicine" proponents?
Is it because it does not fit well with the patient as "consumer" paradigm?
Is it because it shines the light away from social media savvy crowds back to the simple realities of being poor and sick, and the true concept of "community"?
Is it because the doctors in the story are just plain good people, instead of greedy, patronizing, error-prone, rich doctors who don’t even wash their hands?
Is it because it implies that poverty is at the heart of the health care costs conundrum?
Is it because we all decided, in our respective left and right corners, that we know how best to solve the problem and a trifle little thing like evidence is not going to stop us now?

Perhaps the questions are wrong and perhaps there are no answers. Besides, the train has already left the station……

Timeout for Measurement

2011-01-30T12:29:00.000-06:00

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

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

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

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

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

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

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

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

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

EHR Product Management

2011-01-23T20:38:00.003-06:00

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

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

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

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

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

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

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

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