Update on Modular EHR Technology: Harvard’s SMArt Research

DAVID C. KIBBE and BRIAN KLEPPER

ONC awarded four Strategic Health IT Advanced Research Project (SHARP) grants earlier this year to

”...address well-documented problems that have impeded adoption of health IT and to accelerate progress towards achieving nationwide meaningful use of health IT in support of a high-performing, learning health care system.” 

One of these grants was awarded to a Harvard group led by Drs. Ken Mandl and Isaac Kohane, based in Children's Hospital Boston and Harvard Medical School. This research team is tackling the problems associated with developing an ecosystem of modular, plug-and-play medical applications, what we have referred to as Clinical Groupware. (Disclosure: DCK is on the Harvard SHARP grant’s advisory board.) 

Healthy Eats For Data-Hungry Doctors

DAVID C. KIBBE and BRIAN KLEPPER

Imagine that an innovative health plan - aware that half or more of health care cost is waste and that physician costs to obtain the identical outcome can vary by as much as eight fold - hopes to sweep market share by producing better quality health care for a dramatically lower cost. So it begins to evaluate its vast data stores. It’s goal is to identify the specialists, outpatient services and hospitals within each market that, for episodes of specific high-frequency or high value conditions, consistently produce the best outcomes at the lowest cost. Imagine that, because higher quality is typically produced at lower costs - there are generally fewer complications and lower incidences of revisiting treatment - the health plan will pay high performers more than low performers. Just as importantly, it will limit the network, steering more patients to high performers and away from low performers.

Suddenly, it will become very important for physicians and other providers to understand, in detail, how they compare to their peers within specialty, and how to provide the best care possible. And if they find the results aren’t so positive, they may want to figure out where their deficiencies lie, and how they can improve.

Keeping An Eye On The Health Care Prize

Published on Kaiser Health News, 9/20/10

Many reformers undoubtedly believe that passage of the health overhaul law laid the issue to rest. But policy's wheels continue to turn, and the process is anything but over.

Decades of fee-for-service reimbursement became the health industry's article of faith, encouraging virtually everyone in the system to do as much as possible to every patient, with half or more of all expenditures wasted or unnecessary. But it was also a recipe for national disaster. Over the last decade, nearly all U.S. economic growth was absorbed by health care.

Beyond Meaningful Use: Three Five-Year Trends in the Uses of Patient Health Data and Clinical IT

by DAVID C. KIBBE and BRIAN KLEPPER

Finally, we have a Final Rule on the Medicare and Medicaid EHR incentive programs. The rules and criteria are simpler and more flexible, and the measures easier to compute. But they are still an “all or nothing” proposition for physicians, who will have to meet all of the objectives and measures to receive any incentive payment. Doctors who get three-quarters of the way there won’t receive a dime. And a lot of uncertainty remains about dependent processes that CMS and ONC must quickly put in place, like accreditation of “testing and certifying bodies,” and the testing schemas for certification. All in all, we expect most physicians in small practices to sit on the sidelines until the dust settles, likely in 2012 or 2013.

Why The FMA Is Off-Base On Reform

BRIAN KLEPPER and DAVID C. KIBBE
 

At an Orlando meeting last week, Florida Medical Association (FMA) members fumed that their parent, the AMA, isn’t adequately representing Florida’s private practice doctors. After talk of secession and forming a new group, they settled for writing a stern letter urging the AMA to straighten up.

The FMA dustup began with a resolution written by Douglas Stevens MD, a Fort Myers cosmetic surgeon – you can’t make this stuff up – complaining that the AMA’s support for recent reforms was “a severe intrusion in the patient-physician relationship and allows government control over essentially all aspects of medical care.” He wrote that it will “relegate physicians to the role of government employees…and essentially end the profession of medicine as we know it.” A St. Petersburg neurological surgeon, David McKalip, added, “Without (AMA) support, the whole thing (i.e., reform) would have died.”

NHIN Direct: Getting to the Health Internet, Finally!

By DAVID C. KIBBE

I've been spending a lot of time involved in several Work Groups of the NHIN Direct Project, being run by ONC/HHS. The Project is aimed at developing secure, affordable, health data exchange over the Internet so more physicians can participate in Meaningful Use. This project has major significance to physicians in primary care, to all doctors in small and medium size medical practices, and for many small hospitals, as it is a potential "game changer" with implications for both the EHR technology industry and quality improvement movement. Here's some background and explanation about why and how.

Background on health data exchange -- why paper and fax no longer suffice

As a means of getting information from point A to point B, the fax machine works pretty well. But there are three big problems with faxing health data and information. One, it's expensive, mostly due to the staff time spent running the machine, changing paper and ink cartridges, and handling paper jams, busy signals, and wrong numbers. Two, faxes contain unstructured text that at best is stored as a document electronically, but usually turns out as paper. Paper is expensive to store compared with digital documents, but the real problem here is that fax data are "non-computable." Data in a fax is almost always unstructured and therefore unavailable for storage as discrete data elements, e.g. name, address, HbA1c level, etc, in a database. In a database, discrete data can be acted upon by software, but in paper format the data just sits there. And third, faxes are not really secure, as anyone walking by an unattended fax during receive mode can attest.

Not a huge issue, perhaps, until we consider that in 2009-10 Congress and agencies of the federal government have created regulations that require physicians and hospitals participating in the ARRA/HITECH incentives awarded for "meaningful use" of EHR technology to:

* send data to each other for referral and care coordination purposes;
* send their patients alerts and reminders for preventive care;
* offer patients views of their clinical data, such as laboratory results;
* make clinical summaries available to patients after each visit, and: send quality measurement data to CMS.

Given this new situation, which will dramatically increase the flow of data out of medical practices and hospitals, the really pertinent question is this: "If we can't use fax machines to deliver these messages, what can we use?"

As it turns out, transporting health data electronically isn't so easy. Even for doctors/hospitals who use comprehensive EHRs in their practices. The major problem is meeting basic HIPAA security and the maintenance of patient privacy requirements. E-mail with attachments is a hands-down, no-brainer win over faxes in terms of moving data electronically from Doctor-or-Hospital A to Doctor-Hospital-or-Patient B, especially if those attachments are structured data, like the CCR standard xml files. But the way our email clients (Outlook,Entourage, Apple Mail) and online mail accounts with Google or Yahoo are configured, they're not secure enough for health data transport.

(Why not? Well, for one thing Internet Service Providers (ISPs) and normal email clients don't authenticate, that is, assure the identity of, the sender or receiver. So identity can be spoofed. "On the Internet, no one can tell you're a dog," as the quite famous cartoon has put it. For another thing, most email data attachments aren't encrypted during transport. Email protocols, of course, can perform enable email clients to perform these functions, and we'll return to this potential later in this piece.)

The first iteration of the National Health Information Network, or NHIN, was top down, proprietary, and complex -

Roughly six years ago, the Office of the National Coordinator for HIT, ONC, under David Brailer, came up with the idea of the "National Health Information Network" or NHIN to solve the privacy and secure transport problem. As a solution to moving health data from point-to-point, the NHIN was exactly what you might expect would be proposed by the large enterprises, hospital systems, and their legacy vendors who were called upon by ONC for suggestions. Accordingly, the NHIN was to be a network composed of connected Regional Health Information Networks, RHIOs, now called Health Information Exchanges, or HIEs. These large HIEs would create "bridge technology" so that they could communicate with each other. Two of the biggest health systems in the country, who for years had fought interoperability and data exchange, but by 2005 were committed to the NHIN, are the VA Health System and the Department of Defense. Accordingly, in 2005, ONC/HHS let out grants for 18.5 million dollars for the design of the NHIN, to the likes of Accenture and Northrup Grumman, the latter a big defense contractor.

Now, if you were a doctor in 2005 practicing in a four doctor group in suburban Toledo, Ohio -- or one of her patients -- word of this design for the NHIN and the multi-million dollar contracts never reached you. And if it had, you'd probably wonder about its relevance to you or your colleagues. In part, that was because the feds weren't thinking about you at all. To the NHIN planners of 2005-08, your practice was on the very dark "edge" of the network they were designing, while hospitals and integrated health systems, were at its "core." Connecting the "cores" with each other was at the heart of the NHIN design and the work which continues under its newer name, NHIN Connect.

NHIN and NHIN Connect is a vision for a multi-stage, evolutionary approach to health data connectivity, tightly controlled by large enterprises and HIEs. First come the HIEs, then the HIEs connect to one another, and finally connectivity trickles down to the "edge" providers and practices who have EHRs, as these are required or incentivized to join the nearest HIE. I want to emphasize that there is nothing inherently wrong with this construct. But it does centralize decision-making and power in the hands of an elite few.

Think of the way the Cable TV industry developed in this country, and you're getting close to the old NHIN and NHIN Connect. Most Cable TV operators were given exclusive, monopoly contracts to do business in a community or region, based upon the claimed large start-up costs for laying copper and fiber cable. Which meant that customers who wanted cable TV had to sign up with a monopoly, or go without. Similarly, for the original NHIN, the RHIOs and HIEs are being given monopoly rights to establish private health data exchange networks, one per region, and doctors, hospitals, labs, pharmacies, and others will have to sign up with them in order to be able to send and receive data for various purposes, including those requirements to become a Meaningful User of certified EHR technology under the ARRA/HITECH incentive program -- for making electronic referrals, sending alerts and reminders, and clinical summaries to patients.

Another useful analogy with which to compare the NHIN-as-connected-large-enterprises-and-HIEs is the situation that existed just before the Internet, when private networks like AOL and Prodigy were able to charge customers a monthly fee for basic services such as sending emails and viewing the Web through their own browser. The NHIN as originally planned is essentially a framework for the establishment of multiple, Prodigy-like private Internets, which would use the open source but still very complex NHIN Connect Gateway software to move health data between private networks, in many cases for a fee.

Now, you don't need to be the least bit technically savvy to raise some good, solid questions about this arrangement. For example:

Why would we go through the expense and hassle to build and then limit our NHIN experience to monopolistic, Prodigy-like, private health data networks around the country for simple data transport, when the Internet itself is available? Banks, airlines, and e-commerce of all kinds run on secure Internet systems, so why can't health care? HIEs and RHIOs may offer some of their clients much value beyond simple, secure, health data transport, which is fine. But not all of us will need Mac trucks to drive to work. Or:

Isn't this version of the NHIN going to be really, really slow to develop? Physicians and medical practices need to connect their health data by 2011 in order to qualify for Meaningful Use, but the original NHIN design sounds as though it might well take another decade to pull off. Or:

What about the doctors, practices, and patients who don't have an HIE in their vicinity? How will they get connected? HIEs are primarily urban and suburban, and formed around large hospitals or consortia of hospital systems. What are the docs going to do in rural and underserved areas? Or, what about this:

How can health IT innovation occur rapidly when health data and their transport are controlled by a relatively few private networks, and a few very large IT vendors?

NHIN Direct explained and illustrated



It is in large part as a way of answering these questions that the NHIN Direct Project has been initiated by ONC and HHS. The aims of the NHIN Direct Project are "to expand the standards and service definitions that, within a policy framework, constitute the NHIN. Those standards and services will allow organizations to deliver simple, direct, secure and scalable transport of health information over the Internet between known participants in support of Stage 1 meaningful use." Implicit in this objective is the inclusion of small and rural medical practices located at the "edge" for full participation in health data exchange within the scope of the expanded NHIN.

Stated even more simply, NHIN Direct is a specification for the use of a set of existing Internet standards and protocols to allow any individual, organization, or organizational health IT system with an NHIN Direct Address to send health data to any other individual, organization, or organizational health IT system with an NHIN Direct Address, and to do so without having to be part of an HIE or other private network. In practice it is likely that most HIEs and private networks will adopt the NHIN Direct protocols, and thus enable their member individuals and organizations to have NHIN Direct Addresses, and therefore be capable of participation in the direct routing of health data. An NHIN Direct Address is very much like an email address or a web address, the difference being that NHIN Direct Addresses are verifiable, "unspoofable," and stored in a directory for updating.

It is important to recognize that NHIN Direct is NOT a means of sending health data "out into the Internet" to unknown individuals, or to anyone with an email address. To avoid "spoofing," NHIN Direct will require that the sender of health data "knows" the identity of the receiver, and that the exchange between Dr. Kibbe and Dr. Smith using NHIN Direct methods will occur ONLY when there is a trusted method of assuring the identity of each.

How is this trust established? NHIN Direct envisions a new kind of Internet Service Provider, or ISP, to be called a Health Internet Service Provider, or HISP. To be connected to the Internet as a citizen or individual requires the use of an ISP, which may be Time Warner Cable, the local telephone company, or one's place of business or employer. In each case, one's ISP is the "first connection" that allows all of the other Internet and Web features to be available, e.g. email, web browsers, e-commerce, online video, etc.

The duties of a HISP are like those of an ISP, but include specific additional services that will permit providers to simply and securely exchange data using NHIN Direct channels. These include:

Assignment and listing of organizational and individual NHIN Direct Addresses. HISPs will not need to create completely new email or URI addresses for individuals or organizations. Dr. Kibbe can still maintain his email address as Kibbe@FamilyMedicineUSA.org. What the HISP must do is verify that Dr. Kibbe is in fact a physician licensed in the state of North Carolina, and that this address is accurate and correct. The HISP would be responsible for publishing this address to other qualified HISPs looking to pass along health data addressed to Dr. Kibbe, and to maintain and update this address periodically.

Authentication of senders and receivers at the time of transport. There are a number of ways that client applications such as email or a web browser can create a trust relationship with a server to which data is being sent on the Internet, and similarly, several ways in which HISP servers passing on the data to one another can verify and trust one another. Often, digital signatures or certificates are exchanged at the same time that data are encrypted, and these methods both establish trust and disable "sniffing" of the data in transit by nefarious or criminal parties. Within the NHIN Direct specifications, it will be up to each HISP to set a minimal authentication protocol for client applications using the HISP, and each HISP will need to decide whether or not to trust other HISPs, based on their choices of minimal identity management protocols, which each HISP will be required to publish.

Content packaging of sender's message to assure that receiver can consume and interpret it. For handoffs of health data to be efficient, simple packaging standards need to be employed that both senders and receivers, or their EHR technologies, can understand. The messages that can be sent over NHIN Direct will be limited to a very familiar Internet messaging standard known as multipart-MIME, in which various kinds of attached data formats will be permitted, including the CCR standard, CDA CCD, HL7 flat file, and PDF for unstructured data.

In the drawing below, the physician on the left is identified as the "Source to HISP." He or she is sending a message to the physician at the bottom on the right, identified as "HISP to Destination." The individuals or organizations who are senders and receivers may use a number of "edge protocols," e.g. email clients, to send their messages to the HISP with whom they are associated. The HISPs then use a "backbone protocol" to communicate with each other, until the Destination physician or organization is located, at which point the HISP associated with the receiving physician or organization uses another (may be one of several) "edge protocols" to deliver the message.

This model is essentially the same model, and employs many of the same protocols for message transport, as the Internet itself. Only in the case of NHIN Direct there are additional layers of both technology and policy to establish and enforce a framework of trust and security, to assure privacy and confidentiality.
Final comments on the importance of NHIN Direct

The advantages to small and medium size medical practices of a national system that looks like NHIN Direct are substantial. Medical practices will be able to participate in health data exchange without the requirement to join a formal HIE or RHIO, although they will have the option to do so whenever one is established in their areas and if they provide additional value beyond simple, secure transport. Meaningful Use criteria for data exchange to support care coordination, patient engagement, and submission of quality data will be easier to meet, and at lower cost. In fact, the costs to be part of the NHIN Direct will be initially very minimal, and scale upward only as services beyond simple transport are added and subscribed to.

Beyond these tactical and practical issues, there is an essential tension between the older version of the NHIN and the NHIN Direct. If you believe that health care is fundamentally the business of large provider organizations and their large IT corporate vendors, then you're probably comfortable with the NHIN Connect's system of RHIOs and HIEs controlling health data and its flows. Large enterprises like the VA Health System may find they need the added complexity. But if you believe that medicine and most of health care is still primarily a set of service professions, where relationships between providers and patients count, and that individuals should be given the right to control most, if not all, of their health data, the NHIN Direct will seem preferable, or at least worth a try. A similar "decision" was made for the Internet and World Wide Web at large back in the 1990s, when private networks like AOL and Prodigy fell to the wayside in favor of the more open, simpler to use, and more democratic protocols which have created "net neutrality."

Over the next weeks and months we'll see the extent to which these two visions of health data for a National Health Information Network are successful. With any luck, they'll peacefully co-exist side by side.

The Makings of A Great Outcome

By BRIAN KLEPPER

Last week my wife and best friend, Elaine, had massive abdominal surgery. We fully expected her to be an inpatient for a week, but she was home in four and half days. To watch her recover was to see what happens when everything converges: the deep knowledge and skills of excellent, humane physicians; a capable, caring clinical staff; wonderful new technologies; and a lifetime of eating right, being fit and tending to one's health.

She lost two units of blood during the operation. It was four days before she’d be allowed any fluids by mouth, except ice chips, and 5 days before she’d have any food, which started with broth and Jell-O.

But the day following surgery, she moved from her bed to a chair and sat vertically for an hour! Twice! The first time she was dreadfully nauseous. The second time was better.

The second day, she circumnavigated the rectangular halls of the floor - probably an eighth of a mile - twice!

Several things made all this possible. One was the good judgment of her physician team, that did not assume that all was well, and methodically explored until they discovered the deeper problem. In this case, if they had waited, the damage would have been much more significant and the outcome much worse.

Another was great technologies that non-clinicians do not often see and typically aren't aware of. For example, just before surgery, Elaine's anesthesiologist explained that, in addition to the anesthesia during surgery, an epidural block could provide significantly better post-operative pain management than a general anesthetic, while allowing the brain to remain clear.

She agreed and the results were astounding. Even after this traumatic procedure, with an 8 inch traditional incision that goes down the center of her belly, she told a nurse the day following surgery that her pain was "1" on a 10 point scale. And she proved it in her flexibility in the following days. The elimination of pain and the stresses it creates as barriers to recovery are beyond value, and miraculous advances in medicine.

And then there are simple advances that make care dramatically better. Elaine was bedridden, so she was fitted with pneumatic leggings that go around the calves, and massaged the muscles in different rhythmic patterns. This prevented clotting and helped preserve muscle tone, which speeded total recovery.

There is Elaine the patient, who has eaten carefully, worked to be fit and nurtured her own health as a lifestyle for her entire life. When confronted with a difficult situation, her body responded overwhelmingly in her favor. It was clearly payback time, with an incalculable reward.

And finally, none of this would have been possible without wonderful resources like Baptist Health System here in Jacksonville, FL, with its great patient care, overseen by a truly top tier quality officer, Keith Stein MD. This kind of care is available nearly everywhere in the country, and its important not to take it for granted.

In a time that is so cynical, we should celebrate when things work so well. This is not to ignore flaws. As many of you know, I spend plenty of time focused on those.

Elaine and I had a tough week, but it’s worth remembering and being grateful for the fact that our this process was about solutions. And that her care resulted from the cumulative contributions of many important but different sources, allowing a woman ravaged by a disease to succeed beyond our wildest imaginings.

Clinical Groupware - Platforms, Not Software

DAVID C. KIBBE and BRIAN KLEPPER

Clinical Groupware is rapidly gaining acceptance as a term describing a new class of affordable, ergonomic, and Web-based care management tools. Since David first articulated Clinical Groupware's conceptual framework on this blog early last year -- see here and here -- we've been discussing Clinical Groupware with a growing number of people and organizations who want to know what it is, where it's going, and what problems it may solve, particularly for small and medium size medical practices, their patients and their institutional/corporate sponsors and networks.

Clinical Groupware heralds a shift away from medical applications that are primarily based in local hardware and software. It creates a more fluid functionality in those applications, and empowers communications as well, by leveraging Internet connectivity, Web-based data resources, and new services (i.e., capabilities) performed upon these data by agents or applications.

In other words, Clinical Groupware is about platforms that can integrate modular applications, which in turn are supported by subsystems of data services. Although it is still in its infancy, Clinical Groupware is an end-to-end digital revolution in health IT.

It is still too early for a single best example of Clinical Groupware to have emerged. The creation of platforms, modules, and data services in health care has begun only recently, fueled by and borrowing from developments in popular computing that include search, social networking, geo-location, identity management, photo and music-sharing protocols, and remote storage.

Clinical Groupware is sometimes understood in terms of "remote hosting" or an "application service model" (ASP) of software. It is true that this might be a starting point for some users. But as a phenomenon, it is far more powerful than simply running a software program over the Internet instead of on your computer or local area network.

Tim O'Reilly uses "Internet as operating system" as a short-hand way of describing the robust complexity of features and functions available to users of today's browser-based and mobile computing platforms. This approach contrasts markedly with the older client-server computing model. In client-server arrangements, a computer-resident operating system coordinates access to applications and machine resources on a single or, at most, a few computers on a network. In the "Internet as OS" model, the Internet itself coordinates that access across large numbers of computers and users.

The browser or the smart phone may be the means of gaining access to this new and rich "compu-cology," to coin a term. But what really matters most of the time is what is happening between your interfacing device and the many applications on the net that it can reach.

Consider the difference between the mere delivery of an application, such as an ePrescribing software program, over the Internet, versus the richness and complexity of two very popular, although very different computing platforms, Google apps and the iPhone with its app store.

Google's core competency is, of course, its search technology, which almost instantaneously takes the search string from your browser or mobile phone and serves it up to Google's proprietary software at one or more of its massive server farms. But Google also offers free (or very inexpensive) applications such as calendaring, email, photo organizing and sharing, word processing and presentations, mapping, etc. most of which are capable of sharing, indexing, and processing several different types of information in the background in a connected manner. Thus, at the push of a button while in Picasa Web Album, Google's online photo storing/organizing application, one can publish individual photos, or whole albums, to groups of people in one's Gmail account, while also allowing those people to upload new photos to some albums, but not others. It is also easy to place photos on a map location, view both photos and maps in Google Earth, and then share these with others. In each case there are complex data look-ups and indexing occurring, mediated by Internet protocols for identity management and access permissions, in the background.

The iPhone is a more proprietary platform - a "walled garden" in the jargon of the day - that integrates multiple data processing activities, some of which are hardware resident and others that occur online. Its wireless capability supports access to the Web, which can integrate with the built-in GPS location services that are in communication with satellites circling the earth. This arrangement can tap into a world-wide technical infrastructure that can help you find the nearest Chinese food restaurant or get to a nearby hospital trauma center. It can allow you to search for a doctor, map the location of the doctor's office, and get performance ratings on that physician's or organization's quality and service. Many different applications "run on" the iPhone device, but they depend on what O'Reilly calls "network available services" for value creation that far exceeds the features of the phone itself.

In other words, these new Web-based platforms allow distinct functions to interact with and leverage one another, creating a robustness of capability and productivity that was unthinkable in earlier, more limited hosted arrangements. Thinking of these platforms as merely running remotely-hosted applications is to miss their possibilities. Clinical Groupware, a very powerful and practical medical application of this model, is the revolution ahead that will foster intense competition among vendors vying for platform real estate.

Still skeptical? In fact, the leadership at ONC/HHS have already realized that the future of Health IT lies in a whole that is greater than the sum of its parts.

In early April, ONC awarded $60 million to four institutions - Mayo Clinic, Harvard University, University of Texas Health Science Center at Houston and University of Illinois at Urbana-Champaign - through the Strategic Health IT Advanced Research Projects (SHARP) program. Each institution's research projects will identify short- and long-term solutions to address key challenges associated with health IT and meaningful use. John Halamka recently blogged about the Harvard research, which will "investigate, evaluate, and prototype approaches to achieving an “iPhone-like” health information technology platform model, as was first described by Mandl and Kohane in a March 2009 Perspectives article in The New England Journal of Medicine." Further, Halamka writes:

The platform architecture, described as a “SMArt” (Substitutable Medical Applications, reusable technologies) architecture, will provide core services and support extensively networked data from across the health system, as well as facilitate substitutable applications – enabling the equivalent of the iTunes App Store for health.

This new approach to a health information infrastructure was the focus of a June 2009 working group meeting at the Harvard Medical School Center for Biomedical Informatics and an October HIT meeting which brought together more than 100 key stakeholders across academia, government and industry in an exploration of innovative ways to transform the national health IT system.

One of the challenges facing the Clinical Groupware, modular application approach, is that of data exchange between apps and data integration among several different apps. It is clear that the Harvard SHARP research grant will have these problems as high priorities for solutions during 2010 and 2011.

Meaningful Use in the Real World -- Is the Additional Administrative Burden Worth the Bonus for Small Practices?

By DAVID C. KIBBE

An article in the April 10, 2010 New York Times entitled "Doctors and Patients, Lost in Paperwork," brought attention to what may be, in the near term, the Achilles heel of the plan to incentivize doctors for the "meaningful use of EHR technology." The article cited a study published in the Archives of Internal Medicine this past February, which asked a large cohort of physicians in internal medicine training programs about the time they were spending on clerical work, most of which is documentation in patient charts, both paper and electronic. A stunningly large 67.9% of the respondents reported that they were spending "in excess of 4 hours daily" on documentation, while only 38.9% reported spending an equal amount of time in direct patient care.

Now, I am fully aware that practice in the inpatient, hospital setting is not the same as practice in the office, clinic, or ambulatory care environment. Patients tend to be sicker and require more consistent attention while in the hospital, which often means more documentation is necessary. However, the study and the NYT article point to a real world problem that crosses all medical care settings and impacts physicians and other professional providers of all kinds: the enormous burden of documentation, clerical work, and administrative forms completion that impedes real care giving and makes health care less and less efficient even as we add more and more technology.

In both the inpatient and outpatient settings much of the time-consuming and bureaucratic red tape is the product of the fee-for-service health insurance system, in which there are multiple permutations of payment rules, including authorizations and other kinds of forms to be filled out, each health plans forms different from every other health plan. Particularly in the outpatient settings, and for small medical practices, the amount of paper and electronic data collection that must be done to be able to assure payment from a health plan can be staggering. One physician recently compiled this list of activities necessary for a "routine" office visit, CPT coded 99213: verify eligibility; check in; copay determination; get patient to nursing station; see physician; check out; claim to billing person; scrub claim; co-insurance; deductible; send bill to patient; collect remainder; scrutiny; privacy concerns; liability concerns; paperwork_paperwork_telephone calls_paperwork!

Here's the point. In the real world, most physicians in private practice, and particularly those in primary care, feel that they are deeply under water and drowning in administrative trivia that contributes nothing to, but may often detract from, the quality of care experience that they are able to provide their patients. The administrative documentation is interruptive, mindlessly repetitive, often needlessly duplicative, and costly to the practice in terms of time, money, and nerves. This burden is one, and perhaps the major reason, that so many physicians are selling their practices to hospitals and integrated delivery systems. As one family physician recently put it to me, "I just couldn't get to sleep at night worrying about all the insurance hassles. At least now that's someone else's worry."

This is the thorny context into which ONC/HHS are launching the ambitious EHR incentive program legislated into existence by ARRA/HITECH, and which will pay physicians up to $44,000 over the next five years for the "meaningful use of certified EHR technology." While I have expressed on several occasions my basic agreement with this program -- in large part because it rewards the outcomes of the use of health IT and not just the purchase of software and hardware, and because I believe that it focuses health IT on quality improvement where it belongs -- I have also raised the concerns of my fellow practicing physicians across the country, who must evaluate the incentive payments in terms that reflect their real day-to-day struggles to keep their practices afloat financially. Any additional administrative or bureaucratic burden placed upon the already nearly intolerable levels imposed mostly by the private insurance companies and health plans, is not being taken lightly by these doctors, I can assure you.

To be a "meaningful user" of EHR technology will undoubtedly be an easier task for some doctors, and a more difficult one for others. But let's not fool ourselves. Meaningful use criteria include a significant number of new data entry/lookup/calculation tasks be taken on by all participating nurses and physicians, often using new and unfamiliar software programs and hardware devices. Meaningful use is at its core the obligation to collect a designated data set about each and every patient, using computers to store those data, and then assuming the obligation to perform a number of operations upon and with those data. The data include demographics, problems, medications, lab results, allergies, smoking history, and so forth. The operations include electronic prescription writing and refilling; sharing or exchange of the data with other providers for care coordination; reporting of quality measurements to Medicare; making available to patients pertinent personal health information and summaries of their visits; the use of clinical decision support tools and reminders for preventive care; and the recording of all orders for labs, referrals, medications, and radiological studies.

I want to be very clear that, in my opinion, were we to re-design health care in this country from the ground up, I would advocate that this set of data and this level of operational workflow using computerized systems would be nearly ideal as a starting point. Meaningful use puts the focus of health IT on some very fundamental information management tasks that are essential to knowing that the right things have been done for patients, at the right time, and with the right level of resources. It provides the basis for Clinical Groupware to flourish, which implies breakthrough improvement in care coordination and continuity. It is a system that could provide doctors with the tools to act smarter, not just harder, and for them to understand where their gaps in performance truly lie, which is the critical element in starting and sustaining an effort at improvement.

But here's the rub. We're not starting over. We're layering these new requirements on top of an already dysfunctional, highly ingrained and overly-complex system that has shown itself remarkably and stubbornly resistant to reform. And in these circumstances, and for most physicians in medical practices today, Meaningful Use does not appear to them to be a way to practice smarter -- it appears to be a path to just working harder.

Some might argue that today's small medical practices represent a cottage industry that is entirely outdated and ought to be replaced by larger, corporate medical enterprises. They would say that it would be a salutary, even if unintended, outcome of ARRA/HITECH were small practices to be driven out of existence and the doctors, nurses, and staff in them integrated into larger and more productive groups. Perhaps there is some truth to this notion, and perhaps it is even part of the Obama administration's and the ONC/HHS agenda.

However, I would argue that on balance just the reverse is true. Our nation's small medical practices are the "canaries in the coal mine," and their suffocation under the burden of bureaucratic complexity that is non-productive and simply cost-additive is a sign of real danger to everyone else in the industry, not just the smallest and most fragile among us. Forcing the small practices out of business doesn't do anything to relieve the bureaucratic and administrative complexity in the system, it simply moves it to another location, where it will remain a drag on the new and larger units of care. We don't have the numbers, but anecdotally it is evident that some physicians who sell their primary care practices to hospitals do so as a prelude to early retirement and as the last straw in a chain of events that has ended in failure, at least with respect to their expectations for a career as a physician. We may be actually undergoing an invisible shrinkage in our primary care work force right now.

What I would suggest is this: instead of rushing headlong into a clash that further extinguishes the ability of small medical practices to survive economically, and at worst may significantly diminish the nation's primary care capacity at the precise time when we need more of it, the current Congress and White House should work together on a rational trade-off between insurance related hassles and the new work associated with adoption of EHR technology. Our national leaders should understand that unless duplicative, wasteful, and completely non-productive documentation is streamlined and significantly reduced, the nation's small and medium size medical practices will likely sit on the sidelines of ARRA/HITECH -- not because the money is too little, or the technical help offered insufficient, but because they simply don't have the cycles to take on the new paperwork (even if it's computerwork). If that happens Meaningful Use will be at risk of becoming a failed experiment that merely lined the pockets of the highest utilizing, and therefore highest profit, physician groups and hospitals, along with the legacy EHR vendors who they favor.

My guess is that physicians all across the country would applaud an all-out effort by Congress and the Obama administration to simplify administrative/claims workflow and reduce insurance paperwork, and that they would look at the EHR incentive programs with a much less jaundiced eye if they knew that their overhead costs for billing and claims submission were to be cut in half. It will take bold action to bring this about, but it's time to do it. Insurance reform is meaningless unless we drive much of the administrative costs out of the system. And unless we do, asking America's physicians to accept more paperwork isn't realistic.

Are We Adequately Securing Personal Health Information

By BRIAN KLEPPER AND DAVID KIBBE

In a discussion about electronic health records (EHRs) a couple weeks ago, one of the Human Resource team members at a prospective client said, "I don't believe it's possible to secure electronic health data. It's always an accident waiting to happen."

There is some truth to that. More and more, our Personal Health Information (PHI) is in electronic formats that allow it to be exchanged with professionals and organizations throughout the health care continuum. It is highly unlikely that each contact point has the protections to wrap that data up tightly, away from those who would exploit it.

Of course, PHI is among the richest examples of personal data, often with all the key ingredients prized by identify thieves: social security number, birthday, phone numbers, address, and even credit card information. This should give health care organizations considerable pause.

Then consider that, while paper charts contain the same information, electronic files often aggregate hundreds of thousands or even millions of records, information treasures troves for someone really focused on acquiring, mining and making use of the data.

Which is what makes a new health data security survey commissioned by Kroll Fraud Solutions and conducted by HIMSS Analytics, so provocative. As they had in 2008, HIMSS Analytics found that most provider organizations meticulously comply with data security rules and standards. But they're overly confident about the security that compliance actually conveys. Worse, many remain unaware, until confronted by an event, of the devastating implications of even a minor breach.

And the threat is intensifying as the market and technology evolve. In 2010, 19 percent of organizations reported a breach, half-again higher than the 13 percent in 2008. Apparently, both the complexity of the environment and the interest in the data are growing. Security may be diminishing as a result.

And breaches can be hugely costly. A Poneman Institute study found an average cost of $6.75 million for organizational data breaches. This figure is not limited to incidents with malicious origins or even harmful consequences. In January 2009, the Department of Veterans Affairs agreed to pay $20 million to veterans who could show they were hurt when, in 2006, a VA data analyst lost a laptop containing information on 26.5 million patients, nearly every living veteran. The laptop was eventually recovered without apparent data compromise. The VA is now struggling with a new, serious health data breach.

Nor is the impact likely to be financial alone. The larger cost may simply be in the loss of patient confidence. After all, if an organization can't competently manage my data, do I want to hand over management of my family's health?

Perhaps the HIMSS Analytics' study's most important and penetrating finding is that "health care organizations continue to think of data security in specific silos (IT, employees, etc.) and not as an organization-wide responsibility, which creates unwanted gaps in policies and procedures." Nearly 9 in 10 survey respondents said they have policies in place to monitor access to and sharing of health care information. But more than four-fifths of breaches occur in more mundane ways: e.g., lost/stolen laptops, improper document disposal, stolen tapes. In other words, the holes can't be addressed by isolated approaches.

Security is a process, not a product. This means that certification of PHI security must be larger than merely plugging the security gaps in information technology, and must extend to the ways that people access and use information and the information technology.

It is clear that the answers here involve making heath data security an enterprise-wide responsibility, creating highly aware environments resistant to breach in even the most seemingly insignificant interactions. That will demand a significant cultural shift, critically necessary but, as this survey shows, difficult for many organizations' leaders to wrap their heads around.

Brian Klepper, PhD and David C. Kibbe, MD MBA write together on health care innovation, technology and market dynamics.

Value Trumps Price in Onsite Clinics

by BRIAN KLEPPER

Onsite health clinics are new territory for most employers. It can be difficult to sort through the different approaches used by different vendors. Worse, in difficult economic times it’s tempting to “get in” as cheaply as possible.

But like many purchases, you may get what you pay for with clinics, especially if you scrimp. Here are three reasons to favor value over price when considering an onsite clinic vendor:

• An investment. Most employers believe their health plan expenditures are high enough already. For them, a clinic represents an additional expense, and only makes sense if it can provide a return on investment that lowers overall group health and occupational health costs. Ask vendors for data and testimonials that their clinics save money and improve the quality of care.

• Many impacts. Properly configured, clinics do far more than reduce costs for office visits, drugs and lab tests. They can positively impact the chronic diseases that consume two-thirds of a health plan’s costs. They can influence specialty and inpatient care, which the Dartmouth Atlas shows have the highest concentrations of waste. And they can affect the five major areas of occupational health — workers’ compensation primary care, disability management, human resources testing (pre-employment screens, drug screens, Department of Transportation exams), retention/recruitment and lost work time — that, together, cost two to three times as much as a group health premium.

• Total effectiveness results from a clinic’s component medical management mechanisms. Optimizing quality and cost within the complexity of health care requires assembling an array of tools and programs, each targeted to a specific health care problem. Each approach has dedicated costs, but most also produce savings that outweigh their expenses.

For example, incentives such as free office visits, laboratory tests and free standard drugs, mostly low-cost generics, induce employees to use the clinic and help the primary care staff gain more control over the care process. Physicians cost more than nurse practitioners, but are more likely to create a fully realized medical home and have a better chance of influencing downstream care.

Clinical analysis and decision support tools help identify patients with health risks or gaps in care that deserve attention. Onsite, face-to-face disease management programs have a far better chance of influencing chronic disease costs than call center programs.

Modern clinics are a powerful innovation in an employer’s benefits arsenal. But they must be robust to be effective, integrating a variety of proven mechanisms. With those properly in place, the results can be quantifiable improvements in health care quality, cost and employee morale.

In other words, a clinic’s cost may be important. But the value — the benefit you receive for the cost — should be the reason you implement a clinic. It will certainly be how you’ll judge your investment.

On Really Managing Care and Cost

Brian Klepper

One of my favorite health care stories is about Jerry Reeves MD, who in 2004 took the helm of a 300,000 life health plan in Las Vegas, including about 110,000 union members, and drove so much waste out of that system - without reducing benefits and while improving quality - that the union gave members a 60 cent/hour raise. There was no magic here. It was a straightforward and rigorously managed combination of proven approaches.

Dr. Reeves' work betrayed the lie that tremendous health care costs are inevitable. To a large degree, the nation's major health plans abetted this perception when they effectively stopped doing medical management in 1999. (Most have recently begun managing again in earnest.) The result was an explosion in cost - 4 times general inflation and 3.5 times workers earnings between 1999 and 2009 - that has priced a growing percentage of individual and corporate purchasers out of the health coverage market, dangerously destabilizing the health care marketplace and the larger US economy. In 2008, PriceWaterhouse Coopers published a scathing analysis suggesting that $1.2 trillion (55%) of the $2.2 trillion health care spend at that time was waste.

As the chief sponsors for most Americans' health coverage, businesses have struggled to cope with health care cost while identifying value. Large American businesses, with tens or hundreds of thousands of employees, have recruited high profile benefits professionals - think of Jill Berger at Marriott, Ned Holland at Embarq, Peter Hayes at Hannaford Brothers or (the recently retired) Cecily Hall at Microsoft, each with terrific reputations - who, with their staffs, orchestrate sophisticated campaigns focused on the health of their employees and their families, and on the cost-effectiveness of their programming. Even so, few large firms provide comprehensive, quality benefits at a cost that remains consistently below national averages, and for years now America's CEOs have routinely reported that their top business concern, health care, is their most unpredictable, large cost.

For mid-sized business, though, - here I'm referring to firms with 200-5,000 employees - the task is significantly more difficult. Health benefits managers in these companies have far fewer resources, typically work alone without the benefit of staff, and are often overwhelmed by the complexity of their tasks. Held accountable for their organizations' health costs, they often default to whatever the brokers and health plans suggest.

But a few excel. For them, managing the many different issues - e.g., chronic disease, patient engagement, physician self-referrals, specialist and inpatient over-utilization, pharmacy management - is a discipline. A couple years ago, I was introduced to someone like this.

Barbara Barrett was trained as a paralegal. She is now General Manager of TLC Benefit Solutions, Inc., the benefits management arm of Valdosta, GA-based Langdale Industries, Inc., a small conglomerate of 24 firms with 1,000 employees, engaged primarily in wood products for the building construction industry, but also in car dealerships, energy and other concerns.

Valdosta is rural, which puts health benefits programs at a disadvantage. Often there is only one hospital nearby and so little cost competition. Rural Georgians also may have lifestyles that make them prone to chronic diseases, which are expensive. And so on. You get the idea.

Here's the interesting part. Since 2000, when Barbara assumed responsibility for the management of Langdale's employee health benefits, per employee costs have risen from $5,400/year per employee to $6,072/year per employee in 2009. That's an average health plan cost growth of 1.31 percent per year.

I compared Langdale’s health plan cost growth to the average commercial coverage inflation rate for an employer with 200+ employees provided in the Kaiser Family Foundation/Health Research and Educational Trust (KFF/HRET) 2009 Employer Health Benefit Survey. The calculation showed that, in that nine years, Barbara's management allowed Langdale to provide its 1,000 employees and their families with comprehensive medical, dental and drug benefits for $29 million less than the average of other firms that size. That's a nine year savings of $29,000 per employee, or an average of $3,200 per employee per year lower than the national average. All without reducing benefits or transferring the cost burden to employees, and while quantitatively improving quality.

So how did Barbara approach the problem? Here are a few of her steps:

• Under her leadership, Langdale set up TLC Benefit Solutions, a HIPAA-compliant firm that administers and processes Langdale's medical, dental and drug claims. This allowed Barbara to more directly track, manage and control claim overpayments, waste and abuse.

• The claims also gave her immediate access to quality and cost data on doctors, hospitals and other vendors. She supplements these data with external information, like Medicare cost reports for hospitals in the region. This allows her to identify physicians and hospital services that provide low or high value. She then created incentives that steer patients to high value physicians and services and away from low value ones. When complex services necessary to treat certain conditions are not available or of inadequate quality or value locally, she shops the larger region, often sending patients as far away as Atlanta, three and a half hours away.

• She analyzes the claims data to identify which patients have chronic disease and which patients are likely to have a major acute event over the next year. Chronic patients are directed into the company's opt-out disease management/wellness/prevention program. Acute patients are connected with a physician for immediate intervention.

• She provides Langdale's employees and families with confidential health advocate services that explain and encourage use of the company's wellness, prevention and disease management programs. And she uses incentive programs to reward patients who enter these programs and meet targets.

Barbara has mounted many more initiatives in group health, but her responsibilities also extend to life, flex plan, supplemental benefits, retirement plan, workers’ compensation, liability and risk insurance. The results for Langdale in these areas include lower than average absenteeism, disability costs and turnover costs.

The point is that Ms. Barrett and Langdale have been pro-active, endlessly innovative, and aggressive about managing the process. That attitude and rigor has paid off through tremendous savings, yes, but it has also produced a desirable corporate environment that demonstrates that Langdale values its employees and the community. The employees and their families are healthier as a result, and are more productive at work. This has borne unexpected fruit. The industries Langdale is in have been hit particularly hard by the recession, and the benefits savings Barbara’s efforts generate have helped save jobs.

Barbara Barrett and many others like her on the front line are virtually unknown in health care. Most often, their achievements go unnoticed beyond the executive offices.

But they manage the health and costs of populations in a way that all groups should and could be managed.

Brian Klepper is a health care analyst.