Dismantling the Cottage Industry

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

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

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

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

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

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

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

o-Patients

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

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

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

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

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

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

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

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

HIE Guide for the Perplexed

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

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

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

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

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

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

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

Pre-HITECH HIE (the act)

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

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

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

Epilogue

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

Reckless REC Wrecking

The Health Information Technology Extension Program, created and funded by ONC, has completed funding for all 62 Regional Extension Centers (REC), with a grand total of well over half a billion dollars and, predictably, criticism of the program was immediately forthcoming. The RECs are supposedly an impediment to free EHR markets and doomed to failure from the start, which may seem a bit contradictory if you think about it. Anyway, before making further statements and assertions regarding the “recklessness” of the RECs, or the impeding “train wreck” they represent, it may be beneficiary to take a closer look at the program.

Overview

The HIT Extension Program consists of 62 RECs, at least one for each State and territory, and one national Research Center (RC). The stated goal of the program is “to provide outreach and support services to at least 100,000 priority primary care providers within two years”. The individual RECs are supposed to conduct outreach and education campaigns in their respective States and inform physicians on the latest HIT developments and available programs and incentives. The RECs are also chartered to offer support and guidance to physicians selecting and implementing EHRs, particularly Primary Care docs in small practices and in underserved areas. These are the doctors that were left out by the regular market process because they were hard to reach, too expensive to implement and too poor to bother with. While the individual RECs are locally oriented, with feet on the ground in each State and each County, the RC is basically a National forum for RECs to share information and exchange lessons learned.

Funding

Other than a small amount of seed money, RECs are not handed out all those hundreds of millions of dollars of grant funds. RECs are paid for performance. For each physician they touch and manage to recruit, the RECs are paid about $1500. If and when the provider implements an EHR, the RECs receive another equal payment. The last third of the money is handed to the REC if, and only if, the provider achieves Meaningful Use. This arrangement is only in effect for two years. All those who believe that RECs are bound to fail should be reassured by the fact that in that dire case most of the allocated funds will remain with ONC. The RECs are expected to use the ONC seed money and find a way to become sustainable businesses after ONC ceases to support them financially.

Effectively, ONC is funding the start-up of 62 Social Businesses. A Social Business is a business whose purpose is not to amass profits for its founders and shareholders, but instead to better society and solve one social problem; a profitable and sustainable business, not a charity. As any venture capitalist knows, funding a startup is risky business and most startups never make it to the finish line. But some do, and there are strategies that investors employ to both minimize their own risk and maximize the likelihood of success for the entire portfolio. By providing the RECs with centralized operational oversight and by instituting milestone funding, ONC is doing exactly what a careful investor, managing other people’s money, would do.

Timeline

The argument goes something like this: The RECs are running out of time and there is no way they can create thousands of Meaningful Users in a short two years, or what is left of those two years. The common wisdom is that it takes many months, sometimes over a year, to transition a practice from paper to EHR, let alone Meaningful Use. That may be true for your average 30 docs practice. The RECs are not dealing with large multi-specialty practices in suburbia. They are dealing with the solo doc in Booneville, Arkansas. It shouldn’t take longer than 3 to 4 months to get a solo primary care practice from paper charts to Meaningful Use, if the doctor is willing. Granted, the time left for collecting maximum Medicare incentives is rather short, but the RECs constituents are those administering health care to the poor and underserved, many of whom will be receiving incentives from Medicaid. There is plenty of time for Medicaid incentives. And if some RECs fail, as some inevitably will, and are unable to deliver Meaningful Users, they will forfeit most of their allocated grant money. Tax payers in this case will not foot the bill for failure.

Resources

We all know that the Meaningful Use gold rush is creating a shortage of qualified EHR implementation resources, so how are all those RECs going to staff their operations? They certainly cannot compete with private market salaries, since the ONC seed capital comes up very short. Strangely enough, most RECs managed to build their infrastructure already, but will there be enough funds to hire HIT experts and will anybody want to take a job which may prove to be very temporary indeed? It is very unlikely that RECs will attract experienced EHR implementers who are used to flying out to client sites, staying at nice hotels, renting cars and having all their expenses paid while on the road. RECs cannot afford these resources, and RECs do not need these types of resources either. RECs are not selling and implementing EHRs. They are there to see that the vendor does a good job and serve as the physician advocate during the process. Many RECs are University based and others were created by traditional Quality Improvement non-profits. None of them are starting from scratch and, like every startup, they will have to come up with innovative solutions. Some already have, others will learn from those examples and, as John Moore aptly predicts, the remainder will not be around after 2012.

Free Market

Here is my favorite gripe against the REC concept. The RECs are selecting a handful of preferred EHR vendors to recommend to their clients and therefore are interfering with the free market. Particularly since most RECs seem to select the same usual EHR suspects. Along the same lines it can be argued that every hospital Group Purchasing Organization (GPO) is interfering with the free market and so are Sam’s Club and Costco and any other discount for volume program. Why are the RECs consistently selecting EHRs from a small group of about a dozen products when we all “know” that there are 400 EHRs out there? Perhaps it is because there are not 400 viable EHRs out there. There never were. There very well may be 400, or more, companies selling, or trying to sell, EHR software, but very few of those companies ever made it into the main stream and even fewer have enough stability, or appeal, to be a viable choice for an informed consumer. It is worth noting that the EHRs the RECs are selecting are the same ones that physicians independently selected prior to the RECs creation, and thus the ones with the largest existing market share. Perhaps one size does not fit all, but certain sizes do fit most, and anyway, RECs are by definition committed to work with any EHR a physician chooses, whether recommended by the REC or not. When you compare this with the non-profit North Shore Long Island Jewish Health System spending $400 million to roll out one particular EHR to 7000 physicians, I don’t think the RECs are skewing the “free market” too much.

For anybody wondering about the existence of a dark side in the RECs EHR selection process, I would suggest reading the latest EHR selection press release from the Ohio REC. The selection criteria for Ohio seem pretty straight forward: adequate functionality, capacity to do the work, willingness to hire and train Ohio citizens, support provided exclusively in the U.S. and commitment to ongoing certification. Looks rather reasonable to me. By the way, the Ohio REC reported about 40 vendor applications, which makes one wonder where exactly are the other 350 EHR vendors hiding.

Innovation

How about “stifling innovation”? Are the RECs holding back the future of HIT by selecting old “legacy” EHRs? There is no question that the RECs are selecting what they, and most reasonable folks, consider safe products, products that have been around for a while, products with a sizeable install base and products backed by financially stable companies. Would you buy a car from Stimulus Motors, Inc., who’s been in business for 12 months, has 5 employees in the U.S. and 3 customers, just because they advertise usage of “latest technologies”? What are “latest technologies”? If you look at the “legacy” EHRs selected by the RECs, most boast .NET or the latest Java software, industry standard databases, browsers, rich thin clients and even Natural Language Processing engines. The assumption that all innovation must come from 2 guys in a garage is largely a fallacy. Besides, a truly valuable innovation should be able to make its way through any market, whether it is a completely new paradigm or the much exulted iPhone proprietary model. Personally, I hope we don’t devolve back to days when a particular software product was inextricably tied to a particular piece of hardware, and for lack of a better term, call it innovation, but this is better left for another day and another post.

Full Disclosure: I have a financial interest in EHRpathway, LLC which is currently providing consulting services to the Missouri State REC.

Calling Dr. Berwick

On April 27, 2004, President George Bush signed Executive Order 13335 establishing the position of the National Health Information Technology Coordinator. Six years, a recession, a change of administration, a couple of major legislations and a multitude of billions of dollars later, the Office of the National Coordinator for Health Information Technology (ONCHIT) is finally on the road to delivering on the original vision behind that executive order.

The stated mission of ONCHIT, as reiterated in the HITECH Act, was the creation of a nationwide interoperable health information technology infrastructure that makes pertinent information available at the point of care, improves health care quality and coordination, reduces health care costs and disparities and does all that while protecting privacy and security. While the 2004 executive order did not go into much operational detail, the HITECH Act provided instruction on the structure and strategy for building the HIT infrastructure. It is interesting to note that the HITECH Act is comprised of two Titles; Title XIII in Division A which outlines the activities expected from ONCHIT and Title IV in Division B which creates the Medicare & Medicaid stimulus incentives to eligible providers. The notorious “Meaningful Use” term appears only in Title IV and only as a prerequisite for stimulus incentives from CMS and is loosely defined by certified technology, electronic prescribing, information exchange and reporting on clinical quality measures. Additional guidance is provided on the selection of clinical quality measures to be in accordance with Section 1890(a) of the Social Security Act, which awards CMS $10 million every year for contracting development of such measures. Meaningful Use seems a rather benign litmus test for CMS to administer prior to dispersing any stimulus incentives. So why is it that “Meaningful Use” became the defining substance of the ONCHIT mission?

From the first meetings of ONCHIT (or ONC for short), Meaningful Use was seen as the centerpiece for the definition of a roadmap to that elusive nationwide interoperable health information technology (HIT) infrastructure. Meaningful Use Stage 1, Stage 2 and Stage 3 were presented as the milestones on the roadmap to success and, as such, ONC assumed an active role in defining the various Meaningful Use stages. Basically, the interoperable HIT infrastructure is not defined according to the capabilities it must have, but instead it is defined in terms of what users of the emerging infrastructure must achieve in order to obtain incentives. This was largely hailed as a wonderful approach. Instead of just building standards and tools to facilitate a nationwide information exchange, we first mandate what we want to exchange, how it should be recorded, who should record it and where it should be reported, and only then do we build the infrastructure to support our mandates. We then throw in some cash and some penalties just to be sure that if we build it, they will indeed come. Sounds very reasonable, except who is “we”?

Now that Stage 1 of Meaningful Use has been largely put to bed (a few minor adjustments not withstanding), ONC is turning its attention to Stage 2 and perhaps Stage 3. Presumably there will be more of what Stage 1 required, many of the capabilities required in Stage 1 will morph into requirements for actual execution, more data will need to be captured and actually exchanged, more standards will be defined and more clinical performance measures will need to be reported. And just like Stage 1, it seems that ONC is leading the charge for Meaningful Use, instead of CMS who will end up just publishing the requirements. No surprises here, except a brand new workgroup of the Health IT Policy Committee chaired by Dr. Blumenthal himself – a Quality Measures workgroup. There is already a Clinical Quality workgroup in the Health IT Standards Committee, so I was intrigued by the policy aspects of quality measures and ONC’s need to address them.

From listening to the first meeting of the Quality Measures workgroup, it seems this is a group of well-intentioned and very talented folks trying to figure out what clinical indicators should be required for Meaningful Use Stage 2 and Stage3 reporting. The main considerations cited in this meeting were parsimony and HIT-sensitivity; parsimony, in the sense of few broadly applicable measures and HIT-sensitivity in the sense of measures best enabled by EHR technology. The entire conversation (transcribed here) is most interesting. The ONC workgroup is aiming at thoroughly examining work done by traditional quality measures builders, such as NQF, and coming up with its own recommendations to support various health care and health care policy goals. The discussion ranged from how clinical measures should support sustainability goals of federally funded Health Information Exchanges (HIE) to their ability to enable operations of Accountable Care Organizations (ACO) to the fact that lipids measurements should be stratified by risk factors.

It seems that ONC is not solely in the business of providing tools and standards to enable the practice of quality medical care as defined by CMS, but it is actively engaged in deciding how medicine will be practiced in the future. I am not entirely certain how this transformation occurred or whether the initial intent was indeed to have Health Information Technology drive the practice of medicine.

And where is CMS? Where is Dr. Berwick?

By all accounts, the most experienced and knowledgeable visionary leader when it comes to quality of health care, is the new CMS Administrator, Dr. Donald Berwick. From his position as Vice President of Quality-of-Care Measurement for the Harvard Community Health Plan, to the Quality Improvement in Health Care demonstration project, and finally to the Institute for Healthcare Improvement (IHI), one would be hard pressed to find anyone better suited to guide health care quality improvements and shape the meaning of Meaningful Use.
So why is it that health care quality improvements and measurements are left to the technology folks? Isn’t this where Dr. Berwick was supposed to provide unrivaled leadership for the entire nation?

Diffusion of EHR Innovation

No matter what your opinion of Electronic Health Records (EHR) is, you would probably agree that the concept of computerizing medical records represents an innovation of sorts. The spread of innovation, or its diffusion, has been researched and modeled by Rogers[1] as a bell shaped advancement through populations of Innovators, Early Adopters, Early Majority, Late Majority and Laggards (the blue curve in the figure below). At some point during this spread of an innovative solution a Critical Mass of adopters, or Tipping Point, is reached and the innovation is assured widespread diffusion (Gladwell[2]).  Adoption is usually described by an S-shaped curve of adopters vs. time, and the rate of adoption is the slope of the S-shaped curve at any given time (the red curve in the figure).

The Tipping Point occurs right after the rate of adoption assumes its largest value which will be maintained throughout most of the adoption process. It is worth noting that the diffusion of innovation model is not predictive. Many innovations linger and die within the Innovator circle. Another important aspect of the model is that the time variable is not constrained. Depending on the rate of adoption, it may take weeks, months or many years for an Innovation to spread throughout a given population. There is no question that EHR adoption is slowly moving up on the ascending side of a classic diffusion model bell curve, but is it moving fast enough? Is the tipping point visible? Are we there yet?

In order to answer these questions and assess where we are on the path to EHR adoption, we must examine the elements affecting diffusion of new ideas, objects or practices, i.e. Innovations, as they pertain to EHRs.

The Innovation – Not all things classified as Innovations are equal and this may explain why some succeed in becoming main stream and others fail. Rogers[1] suggests four defining characteristics of innovation:

• Relative Advantage – To what degree is the EHR perceived to be better than the practice it aims to supersede – paper charts? The daily debates on the merits of EHR in various health care forums are stark testimony to the fact that potential users are sharply divided on the answer to this question. For some, EHRs are increasing efficiency and improving quality of care for patients. For others, EHRs are impediments to quality of care and an endless money pit for the practice. The biggest advertised advantage of EHRs, interoperability, is little more than a promissory note issued by EHR proponents to prospective adopters. The Government is adding an advantage in the form of stimulus incentives and future financial penalties for non-adoption. This advantage seems to be significant for hospitals and large groups, but less so for small private practices.
• Compatibility – Are EHRs compatible with existing values, past experiences and needs of potential adopters? Here EHRs are being propelled onto the much larger stage of health care reform. They are no longer a humble replacement of pen & paper and fax machines. EHRs are instruments of change; a change from treating one patient at a time the best you can, to considering value-based strategies for the benefit of entire populations, and considering those right at the point of care. This seems to be a major departure from a value system created and enriched across many generations of medical doctors.
• Complexity – Simplicity is always a virtue. The complexity of hospital EHRs, with their unwieldy CPOE modules, has created a perception of EHRs being rigid and unduly complicated tools, which take years to master.  The simple ambulatory EHRs available today, have failed to change these perceptions. To be fair, EHRs are inherently more complex than a piece of paper, but that should not necessarily deter adoption. After all, the wheel was more complex than walking, and making fire was extremely hard initially.
• Trialability – Experimenting with small parts of an innovation before taking the final leap reduces adopters’ risk and anxiety. EHRs can be, and mostly are, implemented in stages, particularly in hospitals. In the ambulatory sector there was a trend to implement electronic prescribing as a trial before complete computerization. Perhaps the best exercise of Trialability for EHRs is the free trials offered by too few vendors.
• Observability – An innovation is more likely to be adopted if its results are easily visible to others. This of course assumes that the results are positive. Unfortunately, successful implementations of EHRs are uneventful and largely anonymous, while their failing counterparts, usually associated with astronomic losses in funds and sometimes lives, are very visible, heavily advertised and frankly more interesting. There is no news in a 3 physician practice in Omaha installing a mid-priced EHR and having no problems to report.

Communication Channels – The news and evaluation of an innovation are spread throughout the community by various means, from mass media to informal peer to peer communications. As every EHR vendor knows, the latter is the most prevalent and effective method of disseminating messages amongst physicians. It is also a very slow method of creating awareness and unless the innovation is indisputably positive, much confusion is created by conflicting messages from friends and colleagues, thus slowing down the diffusion process. The Government’s intervention, with all its glorious publicity and billions of dollars in support of the innovation, is doing wonders in bypassing the conventional “word of mouth” diffusion mechanism. The downside is that EHR is now associated with Big Government and a particular flavor of politics.

Time – Time is involved in diffusion of innovation in several ways.

• On an individual level the innovation–decision process goes through five stages known as: knowledge – persuasion – decision – implementation – confirmation. In EHR industry parlance, these translate to: research – assessment – selection – implementation – adoption. The shorter the innovation-decision individual cycle is and the more people actually complete it without dropping out in its midst and the more positive their adoption experience is, the faster an innovation is expected to diffuse. For EHRs this cycle can range anywhere between a few months for a small practice to several years for a large hospital. The Government imposed Meaningful Use schedules are shortening the innovation-decision cycle for those racing to qualify for maximum incentive. Perversely, the inadequate time allowed for implementation will also increase failure rates and adverse events, which does not bode well for long term diffusion rates.
• Diffusion is also affected by the Innovativeness of the population targeted by the innovation. Here is where we encounter the accusations of physician being inherently opposed to technological advancements, and the counter arguments based on the number of iPhones and iPads already owned by physicians, not to mention all the advanced technologies in imaging, surgery and other medical fields, which are readily embraced by the medical community. When it comes to EHRs though, most docs don’t mind being very late adopters or even laggards.
• The rate of adoption dictates how much time it will take for an innovation to diffuse throughout the system. Unfortunately for EHRs, the rate of adoption is heavily dependent on the 5 characteristics of an innovation and none of those are particularly stellar for EHRs. This is why the rate of EHR adoption prior to HITECH has been lingering at the bottom of a very wide S-curve. The Government intervention, which as mentioned above is increasing the financial advantage, is making a marked difference in the rate of adoption effectively pushing EHRs up the S-curve.

The Context – Innovations are diffused within the boundaries of a social system. The structure, norms and leadership of a system also affect the diffusion of innovations.  Systems whose members are similar in education, social status and beliefs (homophilous) are not well suited to rapid change and innovation. Physicians arguably do form such system. The historical low rates of EHR adoption could be attributed to lack of accepted opinion leaders in general, and those who view EHRs as a positive innovation in particular. The public personas that have an MD after their name and relentlessly advocate for EHR adoption are usually not practicing physicians and as such, are not accepted as respected opinion leaders by most practicing doctors.

The diffusion patterns described so far are assuming that the innovation is optional for any given individual. However, innovations are not always an individual choice. Sometimes the decision to innovate is Authority Driven. Authority driven innovations are faster to be adopted and depending on the level of coercion, may follow a completely different path. Up to HITECH, individual physicians in private practice considered EHRs optional. Those employed by hospitals or large groups were experiencing the effects of authority driven innovation all along, thus the much larger adoption rates in those sectors. Although EHRs are not yet mandatory, the increasing pressure exerted by Government incentives, regulations and penalties is changing the diffusion patterns of the EHR innovation.

Keep in mind that Government exertions do not need to continue until every physician in the country has purchased an EHR. They only need to ensure a critical mass of EHR adopters is created and the mythical Tipping Point is reached. The Tipping Point is usually observed at about 15% adoption under normal circumstances and is marked by the emergence of opinion leaders who adopted the Innovation. EHRs and health care in general are anything but normal and I would expect a larger percentage of adoption to be required before EHRs “take off” in a self-sustaining fashion. As to respected opinion leaders, there are none.

So are we there yet? I don’t think so, but we are awfully close.
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1. Everett M. Rogers (1995), Diffusion of Innovations (Fourth Edition), New York, Free Press.
2. Malcolm Gladwell (2000), The Tipping Point: How Little Things Can Make a Big Difference, New York, Little Brown.

The Red, White and Blue Buttons

On August 3rd President Obama announced the advent of a new button: The Blue Button. The Blue Button is a health data download button. Consumers can presumably click on the Blue Button and their medical records will then commence downloading to their computer (securely, of course). Anybody can get a complete medical record on demand; with no delays from the busy medical records department and no special fees and no rims and rims of paper records to carry around. Sounds like an awesome step forward for medical records portability.

The Centers for Medicare & Medicaid Services (CMS) will make Blue Buttons available for Medicare beneficiaries and so is the Veterans Administration (VA). The Markle Foundation issued a policy paper and a challenge to developers to do something meaningful with the Blue Button data (in partnership with Health 2.0). Crunching the numbers yields about 30% of us with full electronic access to our medical records by virtue of a Blue Button. This is all very exciting and definitely warrants a closer look.

The VA delivers health care and it has an EHR (VistA) and gigantic amounts of electronic medical records to share. The VA also has a website, My HealtheVet, where members can access their latest medical records, view benefits and perform simple transactions, such as requesting meds refills and updating information. My HealtheVet, which is truly a PHR, will now be sporting a Blue Button, so members can download their electronic medical records in ASCII text format. The VA has a sample download file and it looks very useful.

CMS, on the other hand, is basically a payer. CMS will be adding the Blue Button to their member portal, MyMedicare, where claim data will be available for download and also, what seems to be, Self Entered clinical data. Presumably Medicare beneficiaries will update their clinical histories and then push the button to download the file, also in ASCII text format. Unlike the VA, CMS is not quite ready to allow beneficiaries to download this data to their own computers, but prefers that the data is transferred to a commercial PHR instead (e.g. Google Health, Microsoft Health Vault). Why CMS thinks beneficiaries cannot be trusted with their own data, while commercial PHRs can, or how they propose to prevent consumers from keeping copies of their own data, is a bit unclear to me at this point, but CMS “may be conducting a project called "the BlueButton"” to test the concept. As we all know, CMS is very good at pilot projects, so we will probably learn more in time.

The Blue Button is a step in the right direction, but immediately exposes one big problem, a problem that has plagued health care informatics from the start. The VA Blue Button and the CMS Blue Button are creating incompatible text files. There is no common standard for the downloadable information.  Fields have different names (e.g. DOB vs. Date of Birth) and different definitions (e.g. First Name, Last Name vs. Full Name) and objects (e.g. Allergies, Problems) have different subfields. If you compare the VA file and the CMS file, you would be hard pressed to guess that their intended use is identical. Any commercial PHR interested in receiving and incorporating Blue Button files will have to write two separate sets of software to process both VA and CMS files. If private EHRs and payers start adding Blue Buttons to their portals, each providing different information in different formats, we will end up with yet another bewildering array of incompatible data. Shouldn’t the parent “company” of both the VA and CMS (the Federal Government) have defined a Blue Button standard first?

While the Feds work out the Blue Button kinks, I would like to suggest two other buttons that may be even more beneficial than the Blue one, and together will make quite a patriotic splash on any website.

The White Button, so named for those wearing white coats while at work, should allow a physician to get all records for the patient in front of her/him with one click of the White Button. We have the beginnings of a White Button in the form of the, almost complete, medication list that can be obtained in real time from Surescripts. We should build on that concept, which interestingly enough, evolved without the support of massive infrastructure financed by Federal stimulus money. It just made good business sense and it works like a charm.

The Red Button, which will hopefully be used less and less as technology improves, should allow any clinician and any patient who uses health care technology to report safety issues to the FDA, from within the software, and as they occur. Much has been written lately on the need for physicians and hospitals to admit errors, apologize and learn from mistakes. We want to measure quality of physicians’ work and pay them according to outcomes. The same logic should apply to EHR vendors. The Red Button will be our quality measurement tool and should be viewed by HIT vendors as a learning tool as well.
Pay 4 Performance is a two way street.

Appropriately, the day when EHRs routinely come with Red, White and Blue Buttons will be the day we will know that HIT victory has been achieved.