The Ethics of EHR Vendors

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

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

If you ever signed a purchase or service contract, you should know that the opening bid from the seller is just that: the opening bid in the negotiating process to follow. EHR contracts are no different. The initial contracts presented by vendors may contain some, all or none of the following:

• Hold harmless or most often limited liability, for personal injury and death resulting from use of the software. The assertion is frequently made that the software is not intended as a diagnosis and treatment tool and is not a substitute for professional judgment. Many times this clause is accompanied by multiple disclaimers of warranties regarding the accuracy and veracity of the clinical content and decision support provided by the software. The purpose of these terms is to insulate the vendor from malpractice suits. It would be very tempting for a plaintiff, who is usually poor and indebted, to include someone like McKesson or GE in the lawsuit. Juries have even less compassion for corporations than they have for “rich” doctors. The hold harmless clauses, and I have not seen too many, should be removed and the limited liability should be increased from the customary six to twelve months of support fees, to a more significant dollar amount.
• Restrictions placed on the buyer from mentioning the software product name in any format for advertising, marketing or any other purposes, without written permission from the seller. This clause is ridiculous and I presume that’s where the “gag” rules on defect disclosures come from, since I have never seen an explicit line item to that effect. The rather humorous fact is that the vendor usually reserves the right to use the buyer’s name for publicity and marketing purposes. This particular clause should be completely removed, or at the very least changed to only disallow misrepresentation of the relationship between the buyer and the seller.
• Most often the software is warrantied to perform according to the product manuals for ninety days, or not at all, and it is never warrantied to be free of defects or work without interruptions. Would you buy a car with a similar warranty? In all fairness, no software vendor can warranty that the product is “bug free”, because there is no such thing as bug free software. However, respectable vendors in the software industry offer Service Level Agreements (SLAs) outlining processes and timelines for addressing reported issues and financial penalties to the vendor for failing to do so. This brings us to the next salient point.
• Some initial EHR contracts lack any mention of SLAs. There may be descriptions of help desk availability, but no commitments to time frames for resolution and definitely no penalties for non-adherence to SLAs. The buyer must be able to negotiate those into the contract or look elsewhere for software and services.

Contracts containing terms as those described above are examples of a typical purveyor of goods and services trying to make a “good deal” and the buyer’s job is to bargain the terms down to what would be a “good deal” for the buyer, with the final result being somewhere in the middle. Ethical considerations would come into play only if the vendor is knowingly proposing to sell goods that will harm patients, and the buyer knowingly agrees to keep this information secret in return for financial concessions from the vendor, and some of the more vocal opponents of HIT would argue that this is indeed the case. But even then, I seriously doubt that such collusion to disregard patients’ safety for pure monetary gain is a result of vendors and their customers not knowing the difference between right and wrong, or lacking a sound education in the realm of Ethics. Nothing short of legislation and regulation will stop this blatantly predatory behavior if it indeed exists, and I doubt it does.

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

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

Quiz

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


Question: What do the following EHRs have in common?


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

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

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

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

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

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

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

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

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

It’s the Network, stupid

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

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

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

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

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

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

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

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.