Kibbe & Klepper on Health Care

Update on Modular EHR Technology: Harvard’s SMArt Research

2010-10-05T17:58:00.006-04:00

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.)

The research is aimed at creating a “medical apps store” based on the iPhone/iPad model of substitutable applications running on a device or platform. The name of the project, SMArt, stands for “Substitutable Medical Applications, re-useable technology.” The approach could impact both the EHR industry and the federal regulatory and standards process, possibly within a relatively short period, i.e., 1-3 years, so we think it merits your attention. First, the problem.

The dependence on monolithic EHR products - with pre-defined features that are presumably comprehensive - has kept health care IT expensive, difficult to implement, use, and maintain. This approach has impeded innovation, and has helped to perpetuate a fragmented health system with many disconnected “silos” and “data islands.” A vibrant, evolving health care system requires an IT infrastructure that is more like the iPhone and its app store. In other words, we believe that a more practical, contemporary approach involve general purpose platforms designed for communications and data sharing, able to support any number of simple applications, each doing a small set of tasks consistently and reliably.

Here’s Ken Mandl on the topic:

"Under this view of a healthcare infrastructure, as one’s needs evolve, one could substitute simple applications within a platform, rather than substitute in an 'all or nothing' way one vendor product for another. The platform would allow a clinical practice or hospital to select the combination of applications that are most useful for the local environment. A practice or a hospital would be able to download, for example, a medication management application from one vendor and a notifiable disease reporting tool from another. As alternative applications are developed by competitors, the existing ones may be replaced, or new ones added."

This is not simply an academic view. It is the perspective also shared by a growing number of health IT experts and observers, including members of the Clinical Groupware Collaborative, whose modular products and platforms are entering the market in 2010. It is an approach endorsed by the Obama administration, which clearly demonstrated its support for this approach to medical app design in its ONC regulatory framework, most notably in several sections of the Final Rule on standards and implementation specifications. (See http://edocket.access.gpo.gov/2010/pdf/2010-17210.pdf.) Both “complete EHRs” and “EHR modules” may be certified under the new rules. Meaningful Use now explicitly encourages a "modular" approach to EHR technology.

Now to solving the problem. If we dig deeper, we recognize that modular applications can be difficult to integrate with one another in an ad hoc manner. Emulation of the iPhone apps store in health care is complex, and the comparison is more metaphor than strict design principle.

There are several hundred thousand iPhone and iPad apps, and a growing number of apps for the Android OS. Most of these applications, however, do not integrate with one another in the way that, say, an ePrescribing app and a health registry app, built for meaningful use deployment in a medical practice, will have to integrate to be successful. Privacy and security is one important issue. Another is lack of generalizability of the model: one of the reasons that apps on the iPhone or Android cell phones do integrate with one another to any extent is because they have been written for the specific platform, not for all platforms. One can't get an Android app to run on an iPhone, or vice versa.

Let's make sure we understand the difference between "interoperability" and "substitutability," and how each relates to the problem of integrating modular applications. Interoperability (we prefer the term computability; never trust a word that half the population can't pronounce) is the ability of one system to share and understand the data sent from another system. We're making decent progress on interoperability, finally, with the federal recognition of the CCR standard and the CDA CCD as XML standards for clinical summaries required for EHR certification. But even were interoperability 100% achievable now, that would not get us to the level of integration required for the "app store" to work in health care.

Substitutability is required to do that. This is the notion that an application can be replaced with another of similar functionality, easily and without great cost or coordination of the parties involved. Substitutability does not require technical expertise to achieve. For example, if I want to replace one music player on my Android Incredible smart phone, I simply locate the new app in the Android Market, download it, and install it. I can begin playing MP3 files stored on my phone with the new player app immediately. It's not a requirement that the new music player mirror the functionality of the older one exactly. In fact, innovative improvements in features may be one of the reasons I chose to replace the old with the new. What is important is that I did not need any technical expertise or additional technological investments to make the substitution.

Of course, computer operating systems have long allowed one application to be substituted with another without requiring re-engineering. Yet, to date, most electronic health record vendors require very significant IT investment and re-engineering (if they allow it at all) for new functions to be implemented by third parties within their applications. This leads to the well known experience of "vendor lock in" in efforts to automate care processes in hospitals and medical practices. And it’s really dumb.

So, here is the approach that the Harvard researchers are taking to make EHR technology Substitutable Medical Apps, Re-usable Technology, or SMArt. They are using a design that has three basic components: SMArt apps, SMArt APIs, and SMArt containers. Any EMR, EHR, PHR, or research software platform can be a SMArt container by exposing data through the SMArt API to SMArt applications to use. So, by definition SMArt apps always run within the context of a SMArt container. (What does a non-SMArt EHR need to do to become a SMArt container? Hold off for a minute on this important question. It's key, but we have to finesse around this for a bit).

SMArt apps can communicate with a SMArt container in one of two ways: SMArt Connect, and SMArt REST. SMArt Connect is a javascript-based scheme for in-browser apps to use the SMArt API without having to handle explicit authentication. With SMArt Connect, the app runs in an i-frame within the SMArt container, communicating with the container via HTML5 postMessage. Since the end-user (e.g. Doctor Dave logged into his EMR) is already authenticated to the SMArt container, his apps can access permitted data through the existing web session. Apps with server-side requirements, or apps that need offline or background access to the SMArt API, use the REST interface. This interface provides a set of URLs that can be accessed via HTTP GET, POST, PUT, or DELETE to interact with health data.

Writing a SMArt REST app requires a bit more work than a SMArt Connect app, because the app must be able to:

Interact with the SMArt container to obtain tokens (the oAuth "dance")
Store tokens securely on a user-by-user basis
Select the appropriate token and sign each SMArt REST API call

Client-side oAuth libraries in java and python simplify tasks #1 and #3, but there's no easy way around the logistics of token management.

Using this framework and these tools, the SMArt team has built out some very simple SMArt apps that integrate with three different SMArt containers, the CareWeb EHR (from Regenstrief Institute), the Indivo PHR (from Children's Hospital Boston), and i2b2 (from Partners Healthcare System) analytics platform. For example, they have built an app that integrates with the patient's Indivo PHR or the physician's CareWeb EHR, accesses the medication list in either, and determines if the patient is taking a statin drug. It then displays the statin drugs, along with the full medication list.

The beauty of this schema is that it relies on open source code and open standards for the pieces of the puzzle that would be common to all industry participants, e.g. the APIs, but does not require native containers or apps to give up their proprietary code base, just their data. And it still would allow platform-containers to have appropriate control over who gets access to their APIs.

In Part 2 of this piece, we’ll describe the market dynamics necessary to move some critical mass of EHRs and PHRs to adopt this solution to "openness" and data liquidity, and ultimately to one or more “medical apps stores.”

David Kibbe and Brian Klepper write together on health care technology, market dynamics and economics.

Healthy Eats For Data-Hungry Doctors

2010-09-29T06:48:00.008-04:00

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.

Now imagine that clinicians could easily view data about their patients and themselves.

Basic demographics: e.g. age, gender, length of time since last visit.
A problem list based on diagnoses within the past year.
A list of medications prescribed, including ordering physician, dates and fulfillment information.
A list of lab tests ordered, by physician and date.
A list of immunizations.

Suppose the clinician could review, revise or copy this information to create a lasting “patient profile,” saving it online and retrieving it for use at each subsequent visit as appropriate.

Now imagine that this same Internet-based application provides a report based on aggregated patient claims data as current as 8-10 days old, and not just a single health plan's patients, but from all payers. The kinds of reports or “dashboards” available would include, but not be limited to:

A count of patients with particular diagnoses or conditions, by provider.
A count of medications ordered, by most to least common.
A count of lab tests ordered, by most to least common.
Average number of visits per day, week, month.
Percentages of patients meeting targets for key metrics (e.g., blood pressure control, diabetes screening testing, smoking cessation).
Days before payment broken down by insurance companies and health plans.

Then add some basic clinical decision support:

Analytics to identify patients at risk for chronic diseases or major acute events during the next year.
Care gap analyses to create lists of actionable care items for each patient, based on the information in claims, drug, lab and electronic health records.
Artificial-intelligence (AI) driven diagnostic aids.
Best practice guidance.
Online, real-time access to all prescriptions previously filled by the patient, along with automatic drug interaction information.

Now suppose that each physician or clinician could:

Invite other physicians to provide their (de-identified) data to be pooled and compared with others in the pool.
Select benchmarks from local, state, regional, and national data sets to compare each physician’s quality, safety and episodic cost performance.
Start conversations and discussion groups with other physicians based upon questions raised by the data and its analytical indications: e.g., performance, the data itself, its reliability, evidence for higher or lower utilization, etc.
Begin to assemble the components of a "meaningful use" EHR technology suite that will meet the requirements for EHR incentive payments starting in 2011.

We could pose lots of additional “what ifs,” but you get the picture. Information is available now from clinical records, claims, drug and lab orders, and could be provided to all clinicians in a manner that:

When reported in the aggregate, is completely de-identified,
Is compliant with applicable privacy and security laws and regulations, and
Comes with an explicit invitation to make suggestions about how to improve the data’s quality, accuracy, currency and integrity.

We are very near to a 'tipping point' that will make physicians, medical practices, and provider organizations of all kinds very hungry for these kinds of data. There is growing pressure to control cost, both through reform and the marketplace, and moves afoot to significantly penalize physicians and organizations that have unnecessarily high costs.

In all businesses but health care, success is impossible without good information about customers and performance. By contrast, the combination of fee-for-service reimbursement and a lack of cost/quality transparency have let health care business achieve financial success, even when the business itself is oblivious to its performance. Physicians, hospitals and other health care organizations have made so much money, and have increased their incomes/revenues so easily by simply increasing demand, that rigorous monitoring of quality and financial status have been discouraged.

We believe that is all about to change. There is now evidence that health care purchasers (Medicare, health plans, employers, patients) have reached the limits of their capacity to pay and are “putting the money on the stump and running.” In most metropolitan markets, and to a lesser degree in rural markets, health care organizations’ efficiency and productivity will become increasingly critical to their survival.

As we run out of resources to spend on fee-for-service health care, the payment methodology will change to reflect selectivity in purchasing and contracting for services. Affordability and value will become more important than ever.

The government is leading the trend towards health care data collection and transparency of reporting. ARRA/HITECH and the Meaningful Use EHR incentive programs are notable for their emphasis on data collection for both performance and quality measurement.

When one of us (DCK) was in his early forties, he designed and taught courses on data and information management for Don Berwick's Institute for Healthcare Improvement (IHI). Dr. Berwick was never a big proponent for computerization, but he was a stickler on data and its uses for understanding process and outcomes, and for guiding improvement efforts on a continuous basis. He believed strongly in comparing people, teams, and organizations in a collaborative fashion, and using gaps in performance as a stimulus to change for the better. Now he's running the Center for Medicare and Medicaid Services, CMS. Chances are very good he'll likely to continue to push for improved data.

We think it should be possible to create a multi-level offering of data, information, and EHR technology services to physicians and practices at a very reasonable cost. Every element in this article’s lists is not only imagine-able, but do-able already.

Keeping An Eye On The Health Care Prize

2010-09-20T13:50:00.005-04:00

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.

Now, after reform, the industry faces the prospect that the payment equation will be reversed. The money will be tied, in still unclear ways, to doing only what's appropriate. The notion terrifies many health care professionals. Sustaining the industry's current prosperity levels will depend on an ongoing excess from reform's failure.

The Cadillac tax, probably the law's strongest cost control provision, threatens health plans with a 40 percent tax on the portion of premium that's higher than $10,200 (individual) and $27,500 (family), starting in 2018. The logic is straightforward. Health plans, which aggregate lives and dollars, will be encouraged to reduce costs, and will in turn create incentives throughout the continuum for more efficient care delivery. Everyone will follow the money.

The 2018 premium targets may seem high, but they are a short distance from here to where the penalties begin. Just-released data from the Kaiser Family Foundation/HRET 2010 Employer Health Benefits Annual Survey show that the growth in premiums for family coverage slowed dramatically, rising an average of 3 percent this year. (KHN is a project of the Foundation). If premium growth rates don't exceed an average of 8.2 % until 2018, as they have for most of the past decade, then they'll come in under the threshold for the Cadillac tax. But if they rise at all beyond this, consequences will accrue. And, of course, for the many higher cost union and governmental health plans, the threshold is even closer. Many health care professionals will see this mechanism as a financial peril, and seek to neutralize it.

The new law also hangs its hopes on Accountable Care Organizations, still unproven structures that will demand dramatic changes in health systems operations. Integrated Delivery Networks, hospitals, physician group practices and Independent Practice Associations are anxiously awaiting the fall release of the government's proposed rules describing the short- and long-term financial incentives for hitting quality and cost targets. The key question will be whether the arrangement warrants transitioning to a system that actually strives for efficient, quality care. Some thoughtful, experienced market analysts like Jeff Goldsmith and Roger Collier doubt most organizations' capacity to develop and maintain the collaborative trust required for ACO success.

Many physicians, particularly specialists, see moves away from fee-for-service and toward accountability as an assault on "the patient-physician relationship," code for revenue generation. Infuriated over the American Medical Association's support of the health care law, the Florida Medical Association recently issued a "no confidence" voteand joined with 13 other state medical societies to advocate for unregulated health care.

In 2009, health care-related organizations contributed $1.2 billion to Congress to protect their financial interests. That resolve makes it seem unlikely that the nation's wealthiest and most influential economic sector will simply accept constraints on its historical profitability.

Now the health industry's goals are aligned with the GOP, which has vowed to dismantle health reform after November and fostered high profile, state-level lawsuits. With reform teams focused on rule clarification and implementation, opportunities will abound for special interest influence.

Nor is the business community likely to mobilize to ensure that appropriateness and efficiency remain at the core of the law. During the fevered battles surrounding health care reform, mainstream business groups wrote letters to Congress expressing their frustration with the lack of cost controls in the bills. But their lobbying contributions failed to provide a meaningful counterweight to the health industry's influence. They acquiesced, despite a direct productivity interest in higher-value health care and the fact that non-health care business represents five-sixths of the U.S. economy (to health care's one-sixth).

Last week's news that America's employers transferred recent health care cost increases to employees can be understood as a self-imposed limit on their health care financial commitments. If this is confirmed by employers' withdrawal from health plan sponsorship, then the health industry could be stymied. The new rules promoting universal coverage notwithstanding, declining employer subsidies, increasingly nervous international creditors, and a recession that makes it harder to raise and allocate tax dollars could converge to price the rank and file of America's families out of the health care market. American health care could implode.

Even if the forces against health care policy change triumph, though, a new market interest in value is growing rapidly. Innovative new services and tools – Web-based data exchange, analytics to identify patient risk and provider performance, clinical decision support, patient engagement, medical homes, value-based benefit design, new clinical technologies – are achieving cost and quality improvements unimaginable a decade ago.

But everyone in health care is aware that both policy- and market-based reforms' ultimate goals are better care for less money. The operative words, "less money," mean we should expect a fierce, sustained effort by health care groups, bolstered by the opposition political party, to preserve and increase the profitability it has come to feel entitled to.

From where we sit, with the withering campaign that must be in the works, the odds of the new law remaining intact, with teeth, are questionable. For reforms to succeed, then, steady vigilant hands, focused on the nation's larger interest, will be critical.

Brian Klepper, PhD and David C. Kibbe, MD, MBA write together about health care policy, market dynamics, technology and economics.

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

2010-08-31T04:59:00.003-04:00

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.

Nevertheless, while it is good to get Meaningful Use behind us, it may be better still seeing beyond it. After all, the incentive payments for becoming a “meaningful user of certified EHR technology” are merely a small down payment on the savings that could be realized if health care supply, delivery and payment are affected by the changing policy and market environments over the next 5 years. The EHR incentive programs are meant to prime the pump by putting approximately $25 billion, give or take a few billion, into the hands of physicians and hospitals who adopt EHR technology during the 5 years between 2011 and 2016.

During that same time, by comparison, reductions in waste, duplication, and unnecessary procedures might mean savings of $100 billion to Medicare alone,# depending on whose estimate you believe and how effective you think the reforms will be in replacing payment for volume with payment for value. It might be a lot more. Conservative estimates are that 30% of our total national health care expenditure of $2.5 trillion, or over $800 million, is unnecessary and could be eliminated through real reforms. Some authoritative estimates argue that half or more of care costs are unnecessary, so the target jumps to $1.25 trillion a year.

Put another way, the REAL money in is savings from reform, not health IT, though IT is a core tool to identify savings opportunities and to manage care appropriately. Some of it will go to doctors and hospitals that figure out how to achieve cost savings and are given the opportunity to share in those savings, thereby earning amounts that could easily be 10-20 times the value of EHR incentive payments. There is economic opportunity in health care reform for providers who figure out how to address the fragmentation of care, offer care that is coordinated and continuous, deploy the information technology required to capture and analyze fugitive health data, and then serve it up as shared clinical intelligence at the point of care to guide decisions toward safety, quality, and cost-effectiveness.

With these care management cost savings in mind, we consider patient care data and clinical IT systems and components over the next five years likely to be “beyond meaningful use.” Of course, aspects of the EHR Meaningful Use incentive are themselves part of the trends, most notably the standards and protocols which EHR technology vendors must adhere to to obtain ONC/HHS certification. Here are the most important trends to watch, roughly in order of importance:

The expanding uses of structured health data using XML. EHR vendors, HIE companies, consultants, and other middlemen are used to making fortunes on one-off health data interfaces between an EHR and sites of care (e.g., hospital) or service (e.g., lab). The CCR standard, and the CDA CCD, based on the CCR, are now federally approved health data summary standards in XML, the lingua franca for data on the Web and used in e-commerce. There will be other standards that employ XML to make the exchange of health data more standardized and cheaper to put in place. Removing the costs and hassles of fax machines will be the lowest hanging fruit on this vine. But eventually, health data will be Internet-accessible to services that will focus on new applications of the data, like helping doctors and patients identify the best “next steps” for prevention or treatment, or providing warnings that a patient at home is de-stabilizing.

Point-to-point sharing of health data, securely, over the Internet. Local and regional health information exchanges are proliferating, but they still face the problem of communicating beyond their own boundaries. Private networks are a kind of prison. The NHIN Direct Project (soon to be renamed, perhaps as HealthNetwork Direct) is developing policies, standards, and specifications that could open the health data floodgates by using proven, trusted Internet protocols and methods, like SMTP and DNS, to create a secure channel for point-to-point transport of even the most sensitive health information. Anyone with a valid NHIN Direct address will be able to “push” information to anyone else with an NHIN Direct address, regardless of the security moats around private networks, just the same way that individuals using different client applications for email can today communicate. More secure than email in the clear? Certainly. Bound to an enterprise or a particular vendor? No. The country’s doctors and patients don’t have to wait for massive state or regional HIE infrastructures to be built and deployed in order to start making health data more liquid.

Platforms+modular apps+network services. Almost everyone is familiar with this model: it’s the iPhone app store and the Android Market. It’s the use of the Internet without as much dependence on the web browser, with multiple mobile devices for platforms, and with the emphasis on replaceable apps and re-useable technology that offers up data from many sources simultaneously. Why should health care professionals and patients be locked out of the kinds of beneficial experiences we’re all getting used to with Facebook, Twitter, Amazon and Google? In fact, we think a very good argument can be made that social networking software is a key ingredient to care coordination and better teamwork in health care. But first, the older technological gridlock of client-server and walled enterprise HIS -- in which the health care professional is too often a data enterer and too seldom a data user -- has to be cleared from the path. CIOs in hospitals and large groups will eventually see how important connectivity and communications are to reducing overhead and improving productivity, and come to value the clinical groupware world view in which more apps, selectable apps, replaceable apps, are key to making the underlying data really useful. As this occurs, we’re likely to see some health care organizations leapfrog over legacy EHR technology and going straight to network-accessible - that is, cloud - computing solutions.

It will probably take another 5 years for these trends involving applications in personal health and clinical IT to become mainstream. There are possible accelerators and some potential decelerators to this process. Right now, for example, the federal government is clearing the way for innovation with its encouragement of modular EHR technology and incentives for meaningful use of IT rather than simply its purchase.

However, this is a long term process and the relentless lobbying power of legacy vendors threatened by being displaced could still win. If that happens, a retreat from the progress we’ve described, as well as an increasingly bureaucratic apparatus within ONC/CMS, might eventually work against innovation.

Why The FMA Is Off-Base On Reform

2010-08-20T11:38:00.003-04:00

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.”

Well, no. We aren’t sure which reform provisions Dr. Stevens is referring to, but he might have two in mind. One uses subsidies to encourage doctors to obtain Electronic Health Record technologies, so patient information can be easily exchanged and unnecessary or redundant services can be reduced. Some data would be submitted to a federal repository, so doctors can better understand how effectively they practice compared to their peers and how to improve if needed. Of course, physicians opposed to these rules could opt to avoid patients whose care is paid for with public dollars. But we think most doctors will welcome the opportunity to modernize their care.

The second bone of contention was a well-intentioned but flawed 1997 Medicare formula, the Sustainable Growth Rate, which tied physician payments to the growth of the US economy. If Medicare physician spending exceeded the target in one year, then payment the following year would be reduced. But every year, Congress has relented from this discipline, delaying the payment reductions. Now, in 2010, the accumulated cuts would be a whopping 21.2 percent. Despite promises made to the AMA in exchange for support, and with massive costs looming for health care, the financial bailouts, two wars and other needs, Congress is reluctant to spend the additional $200 billion to forgive the cuts. American specialists, who make triple the salaries of their primary care colleagues, are bound to see smaller Medicare checks in coming years.

In the past, we’ve had many differences with the AMA, which was often more focused on physicians and their economic prosperity than on patients and theirs, especially as health insurance costs relentlessly grew four times faster than the economy. The AMA lobbied hard against Medicare and Medicaid, famously recruiting Ronald Reagan to play the “socialized medicine” scare card. Through a secretive, specialist-dominated reimbursement advisory committee, they urged Congress to pay specialists more at the expense of primary care physicians. As a result, it is not far-fetched to lay much of the current health care cost crisis at the AMA’s feet.

But recently, as it strived to reinvigorate itself and appeal to younger physicians, the AMA became more progressive. It mounted a three year campaign for universal coverage. It supported government’s efforts to facilitate and reward the meaningful use of modern computerized tools and the best medical science in clinical practice.

To its credit, the AMA has also learned that it shares influence over health policy. In the intense, 2009 health reform lobbying environment, the AMA contributed $21 million to Congress, but the pharmaceutical/health products industry alone contributed $267 million, or 13 times as much, according to the watchdog group Open Secrets. Many groups assumed that reforms would be achieved, and the AMA knew it was not in control. So it wisely pressed points it believed were in doctors’ interests and compromised when it needed to.

While they are incredibly important to us, American physicians over the last half century have been handsomely, even often excessively, rewarded. But now, the system that has been hugely wasteful must find ways to reduce costs while improving quality, and make sure that care is accessible to everyone. These imperatives are emerging just as data and information tools are becoming more available. Health care will become more like a market than before.

Medical practice is changing profoundly, mostly for the better. In the process, doctors will still be highly valued, but many may earn less.

The FMA’s challenge to the AMA was the old guard denouncing the new. But the new way is what mainstream patients, doctors and the people who pay the bills for care desperately need. It is coming, and the FMA should get on board or out of the way.

NHIN Direct: Getting to the Health Internet, Finally!

2010-05-05T18:44:00.005-04:00

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

2010-05-04T03:25:00.000-04:00

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

2010-04-25T06:39:00.002-04:00

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?

2010-04-11T16:46:00.000-04:00

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

2010-04-05T19:17:00.002-04:00

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

2010-04-02T16:48:00.002-04:00

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

2010-03-22T14:47:00.020-04:00

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.

Vote Yes

2010-03-20T02:33:00.001-04:00

BRIAN KLEPPER and DAVID C. KIBBE

One of us was at a local diner yesterday, when a good friend and health plan broker walked up to say hello. This guy delivers premium increases every day to employers, and understands how broken things are. "I hope Congress votes yes," he said flatly. "We've got to finally move beyond the status quo and try to change the system."

As conflicted as we are over it, we agree and we hope it passes. The die is now cast, so there is no point in continuing to urge a different approach. As terribly flawed as it is on cost controls, the bill represents two very important things that, in our opinion, the nation desperately needs.

First, it will significantly open access, bringing America much closer to universal coverage and making personal financial distress a much less likely outcome of sickness or injury. As Nicholas Kristof pointed out Wednesday, that alone will dramatically improve the health of the nation. Widespread uninsurance and under-insurance have been a national disgrace for decades. Passing this bill would be a commitment to move beyond that shame.

Second, we believe the President is attempting to deal with many difficult problems thoughtfully and in good faith within an extremely toxic political environment. We want to see him succeed, because we think that his approach is good for America.

The bill is not what we hoped for. We're disappointed in the behaviors of both parties. But after a year of wrangling, it is what is possible now. There is no reason the bill's inadequacies can't be revisited.

We hope Congress votes Yes on this bill. Making care and coverage more accessible and more fair would be a momentous and long overdue achievement.

The Surprise

2010-03-14T16:33:00.000-04:00

Brian Klepper

Check out this March 3rd article - see the image - from the recent HIMSS conference, in which Dave Garets, President and CEO of HIMSS Analytics, "gazes into the future and predicts major trends for the next 12 months." HIMSS Analytics is the research and consulting arm of the health IT vendors' association, and presumably on Health IT's leading edge.

From the article:

"Q: What will constitute the surprise of 2010 - the one technology or policy or X-factor that no one saw coming."

"A: Clinical groupware in the ambulatory market that may be the disruptive innovation of ambulatory EMRs."

For the uninitiated, "Clinical Groupware" is a term that is rapidly gaining traction and that describes a new wave of inexpensive, ergonomic, useful Web-based care management tools. David Kibbe coined the phrase and articulated Clinical Groupware's conceptual framework on this blog early last year - see here and then here. He noted that it:

"...captures the basic notion that the primary purpose for using these IT systems is to improve clinical care through communications and coordination involving a team of people, the patient included. And in a manner that fosters accountability in terms of quality and cost."

Dr. Kibbe formulated his ideas, not in isolation, but in continual discussions with innovators developing great new care management tools - e.g., Docsite, Keas, Relay Health, VisionTree, Medicity/NOVO, Salesforce, Practice Fusion - that were realizations of the concept in one form or another. A group of these like-minded developers founded the Clinical Groupware Collaborative, led now by Steve Adams, the founder of RMD Networks. If you're working in this or an aligned area, consider joining.

Which is all by way of saying that it is a stretch to say that "no one," especially HIMSS, saw this coming. From the moment that HIMSS became aware of Clinical Groupware - it's newfound religion on Web-based and modular approaches notwithstanding - influential members were concerned about the trend's disruptiveness. After all, if you're selling EHRs for $25,000 per physician and a new competitor comes along with complete systems or highly useful modular components for a fraction of that - or even free! - the pricing shift will wreak havoc on your revenue and market cap. It's enough to give even the most enthusiastic free marketeer the willies.

That concern found expression through HIMSS influence over CCHIT's - the Certification Commission for Health Information Technology - certification process. CCHIT's criteria were initially spun to favor HIMSS members' products, mostly old-fashioned client-server tools that are complex and not interoperable, and to stifle support of newer, more streamlined solutions like Clinical Groupware. Remember that, early on, everyone thought CCHIT certification would be the criterion for receiving ARRA HITECH stimulus funding, so the criteria could be used to steer the money, conflicts of interest notwithstanding. Fortunately, cooler heads prevailed on the HHS Policy Committee and that heist was averted, or at least it seems so at this point.

The good news is that Dave is right. Clinical Groupware is evolving rapidly and will seamlessly link tools, care teams and patients. It does look disruptive and undoubtedly is the future. If they're watching, this should give serious pause to all those investors driving up Allscripts stock price.

Because, in the end, many old-guard EHRs - the ones Clinical Groupware will replace - produce dreadful customer experiences like the one described recently by John Moore. His article described a market begging for innovation, where the old guard is locked into its past market domination and excessive pricing, and the users are increasingly frustrated.

Of course the irony here is that Clinical Groupware will most surprise and disrupt HIMSS' member organizations, the core of Mr. Garet's constituency, who thought the matter was settled a year ago.

Brian Klepper writes about health care market dynamics and innovation.

Why Rush Vendor Certification of EHR Technologies?

2010-03-08T16:01:00.000-05:00

By DAVID C.I KIBBE and BRIAN KLEPPER

A surprise move by ONC/HHS indicates the wheels may be falling off health IT reform at about the same rate they've fallen off Democrats' broader health reforms.

David Blumenthal and his staff have unveiled two separate plans to test and certify EHR technology products and services. We don't think this is a good idea. We've supported the purpose and spirit of the ARRA/HITECH incentive programs, and believe ONC's/HHS' re-definition of EHR technology puts it on a trajectory to improve the quality and efficiency of health care in the U.S. But this recently-announced two-stage EHR technology certification plan bears all the marks of a hastily drawn up blueprint that, if rushed into production, could easily collapse of its own bureaucratic weight.

The new Proposed Rule puts vendors through the wringer, twice. As defined by ONC, vendors with "complete EHRs" and those with "EHR modules" will have to find an "ONC-approved testing and certification body" (ONC-ATCB) that will take them through a "temporary certification program" from now until end of 2011. Then in 2012, under a "permanent certification program," they'll have to switch over to a National Voluntary Laboratory Accreditation Program (NVLAP)-accredited testing body for testing, after which they must seek an "ONC-approved certification body" (ONC-ACB, not to be confused with ONC-ATCB) that can provide certification. The ONC-ATCB will be accredited by ONC, but the ONC-ACBs will be accredited by an "ONC-approved accreditor" (ONC-AA).

Confused? This is just the start. We can't imagine many federal agency Notices of Proposed Rule Making (NPRM) that have created, in a single document, more new acronyms. And the prose in the document can challenge even the most focused minds. For example, the drafters of the NPRM recognize that things could get a little complicated, saying:

"Should CMS finalize its proposed staggered approach for meaningful use stages, we recognize that some confusion within the HIT industry may arise during 2013 and 2014 because of this apparent inconsistency and the divergent use of the term “meaningful use.”

But, then they go on to clarify:

"We would anticipate, therefore, that ONC-ACBs would clearly indicate the certification criteria used when certifying Complete EHRs and/or EHR Modules, and identify certifications according to the calendar year and month rather than the meaningful use stage to reflect the currency of the certification criteria against which the Complete EHRs and/or EHR Modules have been certified. Consequently, if an eligible professional or eligible hospital were seeking to obtain a certified Complete EHR or certified EHR Module in 2014, for instance, that eligible professional or eligible hospital would look for Complete EHRs and EHR Modules certified in accordance with certification criteria current in 2014, rather than Complete EHRs and EHR Modules certified as meeting certification criteria intended to support meaningful use Stage 1, Stage 2, or Stage 3. We request comments on ways to ensure greater clarity in the certification of Complete EHRs and EHR Modules."

Got that? Glad they're requesting comments, though we're not sure where to start. The use of the word "staggered" to describe ONC's programs is apt: this new NPRM is going to leave a lot of people staggering, as in punch drunk.

We would like to see ONC and HHS abandon temporary certification in favor of a single, permanent certification process, even if it means delaying testing and certification until mid- or late 2011. The hurry appears to be related to the need to have at least some EHR technology tested and certified by the end of 2010, so at least some physicians and hospitals can meet the meaningful use criteria. That would require them to use "certified EHR technology" by the official start year for the incentive programs, 2011.

But we don't think this timetable makes sense any longer, and the rush may jeopardize the whole program. Between meaningful use, accreditation, testing, and certification, there are simply too many moving parts to implement and coordinate in too short a time.

Delays seem inevitable. For example, we know that the release of the meaningful use final rule will be postponed until early summer and perhaps longer due to the large number of comments received and their implications. A consortium of physician membership groups will soon recommend that the meaningful use criteria be simplified. It also predicts that many small and medium sized medical practices will sit on the sidelines during 2011 and 2012, rather than rush into risky attempts to meet the meaningful use requirements. In addition, CMS has said it won't be ready to accept EHR technology product and service data until 2012, at the earliest. That timeline could be ambitious by about a year.

The ONC/HHS interim final rule (IFR) may have inadvertently caused another kind of delay. It set initial standards and implementation specifications for EHR technology - we applauded this - endorsing a modular EHR technology approach that opens the door to industry innovation. But it will take time for market entrants to bring modules and components to their customers, and perhaps longer to integrate different EHR vendors' modules in plug-and-play fashion. In other words, by opening up the market, ONC/HHS created circumstances that will almost certainly delay the goals it seeks.

So what if, to get the certification process right, ONC were to postpone payments by one year? It would be worth it.

The "permanent certification" plan in this new NPRM is very reasonable. Under it, NIST would be involved in setting up the testing of EHR technology software under the auspices of the National Voluntary Laboratory Accreditation Program. A single accrediting body would be chosen by ONC/HHS to oversee, supervise, and accredit the certification entities, following established international standards, including the International Organization for Standardization's (ISO) standards 17011 and Guide 65, that have guided conformity assessment in numerous industries, and ISO 17025 that is used for assuring quality of testing and calibration laboratories.

So each vendor would follow an orderly progression: first, ensuring that the product meets the technical testing criteria and then, having passed those technical tests, moving on to certification. The stability of this process has much to commend it.

We're not alone in thinking that delaying the EHR incentives start date is a good idea. At a HIMSS session on Monday, March 1, Congressman Tom Price (R-Ga.), an orthopedic surgeon, said that ONC's delay in issuing guidance on the certification process has prompted him to organize Congressional members. They'll send a letter to federal officials asking to postpone the start date for for demonstrating meaningful use to qualify for incentive payments. Price said members of Congress are currently collecting signatures for the letter and could send it to HHS within a week.

David Blumenthal is smart, dedicated, and is hiring many talented, experienced people into ONC. But rushing ARRA/HITECH's policy and statute beyond what is humanly possible could ultimately be at cross-purposes with the very goals they're trying to achieve.

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

After the Failure of Reform

2010-03-01T22:13:00.000-05:00

By BRIAN KLEPPER AND DAVID C. KIBBE

The stalemate in the bi-partisan health care summit was cast the moment it was announced. Republicans demanded that the reform process start anew, and Mr. Obama insisted on the Senate bill as the framework going forward. The President may now offer a more modest reform bill that can demonstrate some progress on the health care crisis, but that remains to be seen.

We hoped the White House would seize the opportunity presented by Massachusetts’ election of Scott Brown to begin again, huddling away from the lobbyists to develop a new set of provisions that would include reasonable Republican elements, like medical liability reform, as well as other meaningful cost reduction provisions excluded from the first round of bills: pricing/quality transparency, a move away from fee-for-service reimbursement, and the re-empowerment of primary care.

They took a different path. As Ezra Klein speculated in the Washington Post, Mr. Obama and his advisors may believe that, with the 2010 elections bearing down on Congress, there is too little time to begin again.

But this is a questionable political calculation. The reform process soured the American people and American business on the health care bills. A January 27 Towers Watson/National Business Group on Health (NBGH) survey found that71% of employers believe the bills "will increase the overall cost of health care services in the United States." A February 11 Rasmussen survey found that61% of voters think the bills should have been scrapped and the process started over.

And no wonder. Over the past year, the legalized bribery that is special interest lobbying was fully on display, with members of both parties (but led by the Democrats) taking contributors' money with a gusto unprecedented since the Republican feeding frenzy set off by Newt Gingrich's K-Street Project. A newreport from the Center for Public Integrity shows that "more than 1,750 companies and organizations hired about 4,525 lobbyists — eight for each member of Congress — to influence health reform bills in 2009." Together, they spent $1.2 billion on health care, more than one-third of the $3.47 billion spent by special interests in 2009 to buy influence over policy.

And then there was the brazen political deal making. Mary Landrieu brought $300 million in federal aid home to Louisiana for voting with the Democratic Leadership, which the GOP promptly dubbed "the Louisiana Purchase." Ben Nelson got the Feds to pay for most of Nebraska's Medicaid expansion...in perpetuity. And, on the eve of the Massachusetts Senatorial election, the White House cut a deal that exempted unions from the tax on "Cadillac health plans" until 2018.

The resulting reform provisions - a cynical combination of expert advice, uncompromising ideology and donor quid pro quos - would have extended entitlements while rescuing the industry at the top of a financial bubble, exacerbating the cost growth problem during a recession by replacing dwindling private funding with public dollars. At the same time, the bills specifically avoided committing to approaches that could wring excessive cost from the system.

In truth, either passing or blocking such poor bills would have had little impact on the increasingly threatening crisis. Short of starting over, American health care will continue to face some very harsh realities. More individual and corporate purchasers, particularly small employers, will be priced out of coverage as health care costs explode. This erosion in mainstream coverage is translating to a reduction in total health plan premium - the engine of the health care economy - and to escalating uncompensated care cost loads throughout the system. A plummeting number of insured patients will find it harder and harder to pay for a rapidly growing number of uninsureds and under-insureds.

These are recipes for instability and disaster. And as health care - the nation's largest economic sector, representing one dollar in six and one job in eleven - becomes increasingly unstable, so does the larger US economy.

Americans are increasingly aware that a government in which both parties are compromised by political ideologies and special interests will likely leave them to their own devices in dealing with health care. American business had, to a great extent, put health care benefits decisions on hold until reform was complete. Now it is resigned to continuing to cope with that burden, but with a renewed commitment to innovation. A February 22nd Towers Watson/NBGH survey found that "83% of companies have already revamped or expect to revamp their health care strategy within the next two years, up from 59% in 2009," a clear sign that businesses now think they need to act on their own behalves. (Of course, most individual Americans don't have that latitude.)

One thing is clear. Without reform as it was constituted and the subsidies it promised, the industry faces an onslaught of actions from the marketplace that will focus on its excesses, drive down reimbursement, and hold it more accountable. A long list of innovations - re-empowered primary care; data collaboratives that identify and then create incentives for making the best choices; new technologies like minimally invasive surgeries, point-of-care testing, and clinical decision support tools; medical tourism; clinical groupware; check lists; Health 2.0 business-to-business ventures that streamline health care processes - are now proving they can improve the quality of care while reducing cost.

The result is inescapable. No system this far out of balance can remain unchanged indefinitely. So long as it was influencing the policy process, the health care industry would never course correct in ways that are in our national interest. But as the environment continues to intensify, the market will be driven to embrace and integrate these solutions. One way or another, the health industry is in for real change over the next few years.

Meanwhile, until America meaningfully addresses cost and access through policy, proper health care will continue to be out of reach to many and will threaten many more with personal financial ruin. It will continue to sap the nation's economic strength, and compromise our efforts to lead and compete internationally.

Which is why the President should begin again, and make achieving serious health care policy reform a dedicated goal. In the process, he could challenge special interest influence over policy, and work to refocus the political process on the common interest. We believe the American people can see how the current paradigm is corroding our nation, and would rally behind this approach. More to the point, this was the premise of Mr. Obama's election. The American mainstream is waiting for him to assert his leadership in this way.

Health care reform has stalled and possibly failed for the moment. But the stakes are so great for America that failure cannot be an option.

The Silver Lining

2010-01-20T16:07:00.001-05:00

By BRIAN KLEPPER and DAVID C. KIBBE

Massachusett's voters' stunning rejection of Democrat Martha Coakley, in favor of a not-very-impressive Scott Brown, should be exactly the splash of cold water that the Democratic party - and Congress as a whole - needed. The defeat can be understood in two ways: one large and one fairly small.

First, the large one. This will probably send reform back to the drawing board. Health care is too much in crisis and too pressing to be pushed completely off the table until certain issues - including both access AND cost - are addressed.

Second, this election marks the loss of a single critical Senate seat, but it is also very loud warning shot. The mandate received at the end of 2008 was a resounding call to throw out the Republicans who for more than a decade had ridden roughshod over American values. Yesterday, the Democrats, in one of their most secure strongholds, received the same message. Whatever people in DC think, rank-and-file Americans - not those on the right or left, but the swing voters in the middle who actually determine election results - are very unhappy with the gaming that's been vividly displayed over the last year under the guise of health care reform.

The distaste expressed yesterday probably has little to do with the specific provisions of the bills, except for the largest generalities: that they expand coverage while avoiding a commitment to changes that could significantly reduce cost. But along the way, voters have witnessed -- with an immediacy and transparency that has only been available as a result of the Web -- lawmaking in its worst tradition. There was the White House's deal making with powerful corporate interests like the drug manufacturers even before the proceedings began. And the tremendous lobbying contributions by health care and non-health care special interests in exchange for access to the policy-shaping process. Or the outright bribery of specific Senators and Representatives in exchange for votes. Last week's White House deal with the unions that exempted them from the tax on "Cadillac" health plans until 2018 must have seemed like a perfectly OK arrangement to the people in the center of all this activity, but to normal people who read the paper, it was emblematic of the current modus operandi: If you have power and support the party in power's muddled agenda, you get a special deal.

The most tempting mistake now for the Democrats would be to dig in. President Obama's most appealing characteristic -- the one that got him elected -- was his embrace, his embodiment even, of approaches that would revise the traditional kinds of politics we've seen for the last year throughout the health care reform process. Of late, the most telling complaint about this Presidency so far has been disappointment that, once in office, he seemed to cave in so easily.

Undoubtedly, many Republicans are now rejoicing over the Democrats' loss and the possible defeat of any health care reform legislation. That's unfortunate. The health care crisis is real and remains unaddressed. The pressures it creates, particularly for powerful interests like business, will force Congress to return to it and develop meaningful solutions. Hopefully (though probably unlikely), Congress and particularly the Democrats, will be chastened and wiser. There's a big opportunity here to make lemonade.

There is a new, bipartisan movement in Congress, highlighted on NPR two weeks ago, that would revisit the rules around the relationships between special interests and lawmakers. This is an issue that trumps and is more important than all others, because if every policy is ultimately shaped by those with enough money to buy Congress' favor, then our democracy will be unable to hold.

The silver lining in yesterday's election was that it was a mild, if critical, reminder that, whatever DC thinks, America's center is just as displeased with the current governance as it was with its predecessors. Faced with a much larger rejection in the 1994 elections, President Clinton went on TV, took full responsibility, and then spent his time rebuilding. The good news is that today is a new day, and that, if they're interested in what's good for America over the long term rather than simply themselves over the short term, Congress has the ability to start again in ways that could please the American people and actually work to our collective advantage.

American Health Care Reform: Observations from Health Care Analysts

2010-01-07T16:18:00.003-05:00

Brian Klepper

Here we are, with the first edition of Health Wonk Review (HWR) in a new decade. It is a pregnant moment, as reconciliation begins between the House and Senate health care reform bills, when the best health wonks are weighing in on how we arrived here and what it will probably mean to have a few key successes and some very significant failures at a time when most everyone in the country who doesn’t have power yearns for real solutions. Joe Paduda summed it up very nicely on Managed Care Matters, “…after all this, we’re going to end up with a bill that won’t work – it will not appreciably reduce health care costs today, tomorrow, ever.” Alas, the result is much more a reflection of what America has become than what health care is about.

And so, I have exercised my editor’s prerogative, and veered away from HWR’s standard format to focus this edition on the best, recent health writing I’m aware of, rather than just summarize the writings of submitters. Please indulge me as I have passed over some strong pieces in favor of a smaller, more selective number of consistently very thoughtful, insightful and meaty writers.

I’m hoping this selection will satisfy readers interested in deeply provocative discussions of the most pressing issues at hand, particularly around reform. There’s a lot to chew on here, and I’d urge each of you to curl up on a cold afternoon and read through every one of these columns.

A Face Full of All That Other Mud

Let’s begin with J. D. Kleinke’s thoughtful meditation on yesterday’s Health Care Blog, Is It 2013 (or 2014) Yet?, on the horrific compromises made in the name, not of problem solving, but of ideology. Referring to the watered down Senate bill, he notes that it

“has been so stripped of government management options and control that it is best characterized as the exact opposite of a government takeover. Rather, the bill now on trajectory to become The Plan is – paradoxically – a privatization of the public health problem of the uninsured, a corporatization rather than nationalization of health care’s rotting safety net.”

And this: “…people…have been using the health care reform stage to act out their bigger grievances, philosophical angst, and political frustrations…Something as literally critical to all of our lives as our health care system - regardless of which way an eventual bill goes (including the remote but real possibility of it just going away) - deserves better than a face full of all that other mud.”

Reform Based On The Principles of Competition

On The Health Affairs Blog (12/22/09), Alain Enthoven rebuts Atul Gawande’s New Yorker article^th that compares the health care bills’ pilot programs to those of the Agricultural Extension service that “sparked the agricultural revolution that so benefited the US economy in the first half of the 20 century. “

Both Enthoven and Gawande are icons, and justifiably so for their insights into how health care does and should work. Gawande’s June, 2009 piece, The Cost Conundrum, on health care profiteering in McAllen, Tx, was a sensation in DC, and became required reading for White House staffers looking forward to reforms that could impact the kinds of circumstances Gawande recounted so eloquently.

But in this piece, many of us thought his thesis was a stretch, and Dr. Enthoven lays out the case. One of his conclusions: that we need a commitment to structural reforms, rather than just more experimentation.

“If America wants 1,000 pilot projects to blossom and grow into significant improvements in health care delivery, it must reform its system based on the principles of competition and wide, responsible, informed, individual consumer choice of health plans. Experience shows that people will join if they get to keep the savings.”

The Nearly Trillion-Dollar Lake Mead of Money

In There Be Dragons, The Fiscal Risk of Premium Subsidies in Health Reform (12/14/09), Jeff Goldsmith, with unfailing attention to detail, takes us through a variety of health care principles to explain why 1) the Congressional Budget Office’s (CBO) attempts to model the impacts of subsidies on the private health coverage market are, at best, shots in the dark, and 2) its probably not wise to bet on our political system’s ability to say “no.”

He concludes, “All in all, the fiscal risks from an open-ended new entitlement to premium subsidies are likely to be significantly larger than CBO estimates. Instead of neat economic models with ten variables, we need something closer to chaos theory to explain how the nearly trillion-dollar Lake Mead of money will behave when we completely re-engineer its flow pattern...Behavioral economists would add that anxious health insurance and provider executives would behave differently, perhaps, than entirely rational actors, and act aggressively to preserve their franchises and operating margins. I wouldn’t bet the farm on moderation of present cost and rate trends. All the big risks are on the upside.”

The Medical Cost Tidal Wave

In a simple but straightforward column (12/22/09) on the health plan’s blog, Bruce Bullen, the Interim CEO at Harvard Pilgrim, explains how the structural provisions of the Senate’s final health reform bill will worsen current health care cost trends, which have been more than 4 times general inflation over the last decade.

“… expansion of eligibility and other reforms are largely delayed to 2014, but changes having the effect of increasing health insurance premiums will take effect prior to 2014. Before seeing any material benefits of reform, some will see their Medicare payroll tax rate increase, many fully insured subscribers will, beginning in 2011, see the effects of the health insurance premium tax, and everyone in the commercial market will see the cost-shifting effects of Medicare payment reductions and the tax on drug and medical device manufacturers. Medicare Advantage plan enrollees will also see sharp increases in premiums. Since there is no significant cost containment in the bill, these increases will occur on top of normal medical trend. And because the universal requirement to purchase coverage is weak, adverse selection will further increase costs starting in 2014.”

He concludes, “We can focus on insurance reform all we want, but the medical cost tidal wave continues.”

The Unintended Consequences of Hopelessly Complex and Poorly Thought-Out Laws and Regulations

At the Disease Management Care Blog (12/27/09), Jaan Siderov explicates the seemingly straightforward provision of the Senate bill that would require commercial insurers to “rebate” any excess profitability, if they have a medical loss ratio lower than 80%-85%. The rub lies in the definitions of medical costs and administrative costs, and what is contained in each. Under the Senate’s Management Amendment, the National Association of Insurance Commissioners (NAIC) would be charged with defining each term. But so far,

“the NAIC has not done well [clarifying] if the costs of wellness, prevention, care management, or patient-centered medical home support programs are costs that are assigned to the medical costs that make up the medical loss ratio or if they are administrative costs.”

It remains to be seen whether a compromise plan will correct this kind of confusion.

The Evidence In a typically pithy and to-the-point read (12/31/09), Roy Poses crystallizes what many of us have thought about the national squashing of the US Preventive Services Task Force guidelines for breast cancer screening. Here’s a quote:

“…after 30 years and 8 trials, we still have no convincing evidence that mammographic screening for 40-49 year old women saves lives (which is different from reducing deaths due to breast cancer), or reduces morbidity, improves function, or improves quality of life in the screened population. In the absence of such evidence, how can anyone fault the USPSTF for recommending (not that women not be screened), but that decisions to screen individual people should be based on considered discussion between them and their physicians?”

Dr. Poses calls for better clinical and comparative effectiveness research, another area given short shrift in the current reform proposals.

Who’s Kidding Who

In a policy environment in which half-truths and whoppers are the coin of the realm, nobody pours on the cold water of reality better than Bob Laszewski at Health Policy and Marketplace Review A former Liberty Mutual health insurance executive, Bob’s deep health finance experience has been refined by his long standing in the DC community as a health policy advisor. Throughout the reform process, Bob has written often, and his insights are always to the point. Take, for example, this simple observation from a 12/19/09 post, Coal in Your Christmas Stocking?

“…the Democrats [will] face four health insurance renewal cycles and two elections between 2010 and 2014 when the benefits of the health care bill would finally become effective. That’s four years of new taxes and continuing big health insurance rate increases before voters see any big benefits from what looks like will be a very unpopular bill.”

As I understand it, Bob’s blog is the most widely-read source for DC health wonk types. There’s a good reason for that.

Later

In Health Reform – When Will The Next Shoe Drop (12/22/09) at Managed Care Matters, Joe Paduda lays out an enticing scenario for straightforward, important changes that can’t happen when 60 votes are required, but are eminently doable if the goal is 51. He writes:

“I'd look for a requirement that the Feds negotiate drug prices for Medicare and lower payments for Medicare Advantage plans to start…And it won't stop there. There is a large and growing concern about the cost of entitlement programs and Part D is particularly problematic. By attacking drug costs and thereby reducing Medicare's future liability, liberal Democrats will make it very tough for their opponents to use the 'big spender' attack angle in November.”

Two On What To Expect

Jane Sarasohn-Kahn, one of our most gifted, industrious and grounded health care prognosticators, has a broad-reaching summary of the certain trends – employee cost-sharing, employer ‘nudging’ of employees toward wellness, health information technology becoming more mainstream among physicians, participatory medicine/online health tools – that will remain in play in “What to Expect When You’re Expecting...Health Reform on Health Populi. She says,

“With the US still in recession, the issue of managing costs will be Job #1 in health care for institutional and business stakeholders, from health plans and employers to pharma and medical device companies.”

Matthew Holt, a Founder of Health Wonk Review as well as The Health Care Blog, and one of the most incisive, if irreverent, health care commentators writing today, suggests five major trends. He wonders how the changes brought about in policy will take shape in the market, and how changes in the political winds will affect the ability to continue reforms. He thinks that HHS’ Office of the National Coordinator for Health IT’s transformation initiatives will have a profound impact on everyone in health care - "’It's clear that we are not going to simply see mass adoption of the mainstream EMR vendors’ products." - and that patients are beginning to expect more access to information, especially their own. And that quality of care, especially at the end of life, is finally becoming a concrete, mainstream issue.

The Verdict

Each of these voices describes different facets of a complex process. These are some of the most experienced and prominent health care authorities working today, and they don't hesitate to conceal their disappointment at what is passing for reform.

It is not enough to dismiss this Congressional health care reform process as just another example of sausage-making. As David Kibbe, Alain Enthoven, Bob Laszewski and I discussed here, America's health care industry has placed the national economic security in deep peril. An important goal, a commitment to structural changes that can significantly reduce the one-third or more of health care cost that is waste, now appears to have been squandered by a system that welcomes influence over policy in exchange for special interest financial contributions.

It is unlikely that meaningful health care change will be forthcoming after this process. The forces of special interest influences are vigilant.

Nor will the problems that were on the table now disappear just because they’ve been ignored. They’ll fester and worsen until business rises up in revolt to force the issue, or necessity overwhelms the capacity of lobbying to drive public policy. Unfortunately, the process of getting to that inevitable terrible moment won’t be pretty or pleasant.

Brian Klepper is a health care analyst and commentator based in Atlantic Beach, FL.

EHRs for a Small Planet

2010-01-05T07:45:00.001-05:00

by DAVID C. KIBBE and BRIAN KLEPPER

Right now, American health care information technology is undergoing two enormous leaps. First, it is moving onto Web-based and mobile platforms - which are less expensive and facilitate information exchange - and away from client-server enterprise-centric technologies, which are more expensive and have limited interoperability. In addition, more EHR development activity is headed into the cloud, driven by large consumer-based firms with the technological depth to take it there. Both these trends will facilitate greater openness, lower user cost, improved ease of use, and faster adoption of EHRs.

But they could also impact the shape of EHR technologies in another profoundly important way. What is often lost in our discussions about electronic health record technology in the US is the relationship these tools have to our health and health care problems...globally. We could be designing our health IT in ways that are good for the health of people both here and around the world, not simply to enhance care in the US.

Designing health data and management tools only for the particular operational needs of the current US health system may be doubly wrongheaded: It risks locking us into outdated technology and an expensive, dead-end path, while, at the same time, it could restrict collaborative exchanges of ideas and innovations that could improve health care here and abroad through better designed information technology.

Perhaps we should design EHRs for a small planet.

Rene Dubos (1901-1982) was a microbiologist who produced the first commercially marketed antibiotic. He also wrote widely about the relationship of humans with their environment, notably in So Human an Animal (1968), which won a Pullitzer Prize. In 1972, with economist Barbara Ward, he co-authored Only One Earth: The Care and Maintenance of a Small Planet, which set the issues and tone for the first major international conference on the environment. Dubos also first used the term "think globally, act locally," advice to consider the widest possible consequences of our behaviors, but to take action in our own communities.

What would our EHR technology design efforts in the US look like if we incorporated Dubos' more expansive framework? What principles might shift our thinking about EHRs away from America's failing health system paradigm -- with its illusion of unlimited resources, delivered by a fixed and ritualized set of professionals and institutions, and costs that double with each passing decade -- towards a vision in which EHRs promote sustainable efforts in disease prevention, health improvement, social responsibility, and environmental protection? How might we think about EHRs globally while acting locally?

Principle 1: Define success with local health and health care problems in mind.

Defining EHR success is important, partly because US federal policy for EHR adoption is currently so dynamic. It would be easy to simply define success in terms of physicians' short term acquisition of today's EHRs, and the economic boost that might result from new government IT spending (e.g., IT jobs and EHR vendor profits). But Dubos might argue that successful EHR adoption should require measurable social and ecological benefits in the communities where the technologies are deployed, after consideration of the 'big picture' in which health spending is one among many societal priorities competing for limited societal resources, and therefore ought to be conservative.

The US' current EHR adoption strategy channels money directly to doctors and hospitals, among the most privileged professional groups in any community. It could, instead, send those funds directly into the communities served, focusing on the local circumstances that result in fragmented, disorganized, and inconsistent health care delivery within driving distances of its citizens. EHR technologies could address communities' continuity and access-to-care problems, and relate these to major preventative and chronic illness management challenges, e.g. vaccinations, obesity, and risks of heart disease. More and more people in adjoining communities could be reached by building on successes. Lowering health costs nationally is an important goal, to be sure. Maybe the best way to get there is to stimulate uses of health IT to improve individual and community health through local action. (It goes without saying that the system's financial incentives would also have to be re-aligned.)

Thinking globally and acting locally would require us to study and plan how EHRs might benefit different communities, as unique populations with particular health risks, public health problems, and care delivery challenges. We would have to study those risks and challenges in each community, or in groups of neighboring communities. This is not easy, and it can be time consuming.

But the alternative, which seems to be to spend huge amounts of state, federal, and local dollars on one-size-fits-all health IT projects, top-down EHR systems that work for the VA or DOD but probably nowhere else, or data exchange efforts that may not be capable of solving, or even suitable to, the problems most at hand in that locale, could be simply disastrously wasteful by comparison. What works in central Indiana, quite honestly, may not be the right thing for Green Bay, Wisconsin, Helena, Montana, or Pamlico County, North Carolina.

Principle 2: Make the best possible use of existing IT resources before building or installing expensive new EHR systems.

Rather than ask "What could we do if everyone had computer systems like the most advanced large groups, e.g. Kaiser or the VA, let's ask "What could we accomplish if we utilize the computers everyone already has?"

Experience has shown that it is not wise to expect big and complicated things to somehow become small and simple. For one thing, costs don't necessarily scale. In contrast, though, the evidence is now overwhelming that with browser-based software running on personal computers and cell phones, and small applications running on hand-held devices, like the iPhone, consumer use can grow at extremely rapid rates and lead to complex social networks, rapid communications and feedback loops, and massive search and data analysis capability.

Examples abound of the kinds of resources available through inexpensive personal computers connected to the Internet, cell phones, and the newer smart phone technologies. Skype, the Internet-based voice communications company, has over 500 million registered users world-wide, which would make it the largest telecom carrier, if it were one. The top 25 wireless providers globally already service over 3 billion registered customers. The iPhone, introduced in 2008, has more than 57 million users, the fastest user growth in consumer technology in history, many times faster than the earlier rapid growth in PCs or the Apple iPod. Facebook - the social network platform where people send email, chat, share photos, and share interests - now has 350 million users and is growing at 660,000 per day! Lest we forget, these ubiquitous technologies are not just used for fun and games: massive amounts of data are being exchanged as well. And they are getting cheaper to own and operate all the time.

And yet they are for the most part useful only at the margins of health care, an industry that has somehow walled itself off from IT modernity. We certainly have not yet capitalized on the health and medical uses of the extraordinary networked computing resources available now in almost every home and work site in this country. EHRs for a small planet need not cost $54,000 per physician, which is the current estimate used by ONC and HHS.

It would be a critical mistake to waste our resources, time, and effort building new specialized state or regional data centers requiring complex and proprietary identity management technology for access, and to train a generation of IT professionals how to manage these expensive centers and the technology deployed there, when better design and efficiency could be obtained by use of the existing "off the shelf" general- and multi-purpose data highways, application platforms, and end-user computing capacity now available for health data exchange.

Principle 3: Design EHRs for the smallest unit of care delivery, with a focus on connectivity and communications.

Connectable EHRs can be designed for small medical practices and clinics in primary care, where the great majority of care is delivered, and for patients' themselves -- in their homes and places of work. Designed from the local, grassroots perspective, EHR technologies would also focus on affordability, ease-of-use, and especially on connectivity and continuity of information across those units in a given community, using existing computers, cell phones, the Internet, and yes, even fax machines.

Our current approach to health care IT, in contrast, is biased towards the needs of a handfull of professionals working in a relatively small number of large enterprises, such as hospital systems, and in large multi-specialty practices. These large units typically represent the most complex "use cases" for EHRs, based on the needs of the most complicated and sickest patients, requiring the most intensive usage of drugs and pharmaceuticals, and at the far end of the spectrum in terms of complicated ancillary medical devices, such as MRIs, medicated stents and proton accelerators.

These large health care units are often fiercely competitive and have little use for data exchange with competitors, and even less interest in using computing resources to reach across the communities they serve. As a result, they may be among the least appropriate and least competent stewards of community-based health IT resources. And yet their representatives dominate the steering committees and governance boards for the nation's health information exchanges (HIEs) and regional health information organizations (RHIOs), where a big chunk of the federal funding is now going.

If waste is the failure of design, then designing EHRs for a small planet would avoid lengthy and disruptive installations and long training cycles involving expert consultants. Instead, they would favor modular, browser-based EHR software that are familiar to physicians, their staffs, and their patients, and that can be navigated simply.

Implicit in this design priniciple is a requirement for minimal training that focuses on how to use the software to best improve care, rather than on which buttons to push in which sequence to optimize fee-for-service reimbursement. EHR software that looks more like Facebook and less like a database manager's tool kit, that can work through web browsers and mobile devices, and that can be incrementally expanded as new uses arise, is not only likely to be more adoptable than today's EHRs, but also less expensive to own and operate.

Principle 4: Recognize that what sustains most information technologies is people's desire to connect with one another.

Email is the "killer app" of the Internet. Facebook and Twitter have become the amazingly fast growing online social networks. Human beings seek connection at nearly every opportunity. Technologies that facilitate that connectedness and then provide key utilities are most likely to succeed.

Maintaining and restoring health, preventing disease, and the act of caring for others who are in need due to problems of the body and mind: these are among the most basic social activities of human beings, our communities, and our cultures. And yet, for complex reasons associated with money and power, our health system and the care it delivers is too often fragmented, dis-connected, and isolated. And its technological disconnection is both a symptom and a substrate of this phenomenon. Physicians and nurses face many barriers in communicating amongst themselves, with their patients and with their patients' caregivers. The current crop of EHR products do virtually nothing to address this problem. In fact, EHRs in the US may have exacerbated our health care dis-connectedness.

EHRs that can share data, information, and connect the experience of patients, caregivers and doctors more directly are much more likely to be utilized at the community level than EHRs that in essence capture and remove data, isolating them and their potential social uses in faraway databases that no one can get into.

The huge success of health-related social websites - like PatientsLikeMe.com, DiabeticConnect,com and Sermo.com - are testament to the desire that many people have to close what Adam Bosworth has called the "collaboration gap" that stands between the limitations of the legacy health care system and the almost infinite benefits that arise from participating in self-help and online socializing activities. People who share their experiences - and data about themselves - know that this is helping them close the collaboration gap. But this gap is being perpetuated by EHRs that are organization- and enterprise-centered, and can only be substantially closed if physicians and medical groups in communities around the country use EHR technology to leapfrog over the communications and socialization barriers inherent in their older technologies. This will require new forms of EHR technology capable of socialization, which we have described elsewhere as Clinical Groupware.

Principle 5: Separate data from the applications and from the transport layer.

It is a stunningly simple yet powerful feature of the most familiar and widely-used information technologies that data - the message - is deliverable regardless of the sending or receiving applications, and independent of the network or transport layer that carries it. Email messages can be sent and received via many hundreds of client applications (what you and your computer use to compose the email or to display a received email.) Email and messaging services can carry many dozens of different kinds of attachments, e.g. pdf documents, across both open and secure networks, and networks with different kinds and levels of security protection in place.

This is a small planet idea that is the direct consequence of the openness of Internet protocols, but one that has not yet become incorporated in US health care, where data messages, applications, and network transport protocols remain unendingly, even stupifyingly, proprietary. Not only do these approaches perpetuate "walled gardens" - hospitals using one EHR system can't send a simple electronic medical summary to another hospital using another EHR system across the street -- but it also is a barrier to the innovators who would design, build and implement new, low cost applications like modular EHRs.

Clay Shirky makes this point in a blog post recently:

Thus the question for broad participation... is not: “What will the most complete system look like for the richest and most technically adept institutions?” Rather, it is: "What’s the simplest and most low cost way for a small vendor or new market entrant to get a small practice tied in?"

...Here’s what a workable set of transport standards will not do: It will not assume to know what kind of applications any given network participant is running locally. Once the data are delivered, it should be usable by everything from the simplest to the most complex application, since the recipient of the data will have the best understanding of what works in their local context.

This ability to separate data from transport and applications from data is the essential pre-condition for innovation — a group that has a valuable new idea for presentation of data for clinical use should not also be forced to think about the data encoding or the way the data are transported. Groups working on new data encodings should not be tied to a pre-existing suite of potential applications, nor should they have to change anything in the transport layer to send the new data out, and so on.

Patients and doctors in offices, homes, laboratories and pharmacies most often need information, and most often they need it in the form of small amounts of summary data such as a medication or problem/diagnosis list, a specific allergy, a limited number of recent or historically important lab tests or images. Where there is continuity of care and information flow, especially, there is rarely the need to access the complete or comprehensive medical record or its full contents.

For most ambulatory and outpatient clinical care needs, simple dashboard and summary health "EHR light" products may be sufficient, and there is a logical progression towards more complex health IT as the acuity of care increases. Modular design of EHR technologies may help to bridge this gap without creating large discontinuities of user interfaces and may also keep prices for health IT in the community setting at a lower point than otherwise.

*****

In the U.S., many of our health problems result from the growing burden of chronic diseases occasioned both by an aging population and our sedentary lifestyles. In much of the developing world, by contrast, the local health problems - pandemics like HIV/AIDs, malaria, and drug-resistant tuberculosis - result from poverty and a lack of basic public health resources. However, similar EHR technology in each of these settings can provide efficient health data exchange and information management. Both individual and population health status could be improved with medical records that are inexpensive, simple to use, and capable of network exchange

To this point, each of the above principles for small planet health IT is already being put in place effectively in many developing countries, where cell phones are used to remind patients of their medication regimens and are the vehicle for relaying laboratory test results and vaccination information from provider to provider in sparsely populated and very resource-limited communities. As part of the Millenium Villages Project in Ghana, for example, cell phones are part of a program that is dramatically improving the chances of survival for pregnant women and their newborns.

Our brethren in other countries, developed and developing, face many of the same challenges obtaining good quality health care that we do here in the United States, including realizing the promise and hope offered by health IT. If we persist in federal EHR policies that "over-serve" local US communities' needs by developing complex and expensive systems of health IT, we may not only be missing the mark at home. We might also be missing the opportunity of helping the other inhabitants of this small planet.

2009: A Year of Surprises and Change for the EHR Technology Market

2009-12-06T09:01:00.000-05:00

By DAVID C. KIBBE and BRIAN KLEPPER  

2009 began with a bang for legacy Electronic Health Record (EHR) vendors, promising strong sales and windfall profits on the heels of stimulus package incentive bonuses initially worth more than $19 billion to doctors and hospitals. But things changed dramatically along the way.

Here ten surprises and notable events that have impacted the EHR market:

Payment for Meaningful Use of EHR technology, not for the software and hardware itself.

The idea that using EHR technologies ought to produce improvements in quality of care, better communication with patients, enhanced safety, and better public health reporting -- and that these outcomes ought to be monitored and providers held accountable for their achievement -- was itself a surprising innovation in 2009. It has to be counted among the best 10 health care ideas to come out of government in the past generation.

For several years many EHR technology vendors had expected federal money to enhance IT adoption flowing straight to them and their investors. But the interpretation of "meaningful use" by David Blumenthal, MD and his staff and advisors at the Office of the National Coordinator (ONC) proved that they want EHR adoption tightly linked with health reform and capable of supporting accountable care payment schemes, such as bundled payment, pay-for-performance, and accountable care organizations. The burden of proof that EHRs are being used appropriately lies squarely on the physicians and hospitals that purchase them.

It's become PC to ask tough questions about EHRs, quality, and health care costs

For several years it seemed that any criticism of EHRs, any questioning of the relationship between the use of health IT and the attendant quality of care or its cost, was off limits in policy discussions. EHRs were all good, all the time. But in 2009 we've seen a trickle become a torrent of serious challenges to the conventional wisdom about EHR value. It's come from diverse sources including distinguished federal science panels, academic studies, testimony before ONC and the National Committee of Vital and Health Statistics (NCVHS), and from a chorus of individual users with personal experiences to relate on listservs and blogs. While generally extolling the virtues of health care computerization, these voices of dissent have drawn attention to the large gaps in performance, ease-of-use, and standardization that plague the current crop of EHR products and services.

Perhaps more importantly, in the process they have unburdened the physicians and hospitals who have sat on the sidelines from being labeled "slow adopters," anti-technology, cheapskates, and even worse. As it turns out, these folks may have simply not seen the value in current EHR products that offer mediocre performance at best, and which have, so far, mostly demanded a king's ransom to purchase, implement, and sustain. We expect to see continued critical examination of the uses of EHR technologies, and new reporting that links health IT with documented enhancements in safety of care, quality improvement, and cost efficiencies.

CCHIT's loss of invulnerability and the displacement of its monopoly on EHR certification

2009 didn't go as well as the Certification Commission on Health IT, or CCHIT (pronounced sea-chit) might have liked. The HIT Policy Committee advised ONC to replace the vendor-sponsored methodologies for both selecting certification criteria and then carrying out the "certification." Instead, the criteria for "certifiied EHR technologies" would be set through an HHS Certification process, and then an international standards-based process used for certification and for selecting accredited certifying entities on the basis of competitive bid contracting.

This was a stunning reversal for the industry-leading companies involved with CCHIT. Many external to the process had criticized CCHIT as a "foxes guarding the henhouse" scheme, with apparent conflicts of interest that would never be tolerated in other industries. But CCHIT's real sins were a Byzantine certification process that failed to increase EHR adoption among physicians and hospitals, and the glaring fact that, despite an interoperability certification process, it failed to promote health data exchange among EHR applications. Among the most dramatic and damning testimonies at the HIT Policy Committee hearings in July was that of the CIO of East Texas Health System, who testified that her organization had jettisoned a multi-million dollar CCHIT certified (for interoperability) HIT system because it couldn't exchange information with another CCHIT certified system.

Then, recently, CCHIT's embattled CEO Mark Leavitt, MD announced his resignation from the organization. Although still retaining a primum inter pares status as an EHR-certifying entity due to its contractual ties to ONC, it seems likely that several other testing labs will compete with CCHIT for the contracts to certify EHRs under the ARRA/HITECH program. In fact, one company, Drummond Group, announced on November 2, 2009, that it would submit to become a certifying body upon the release of the requirements, expected in late December. The hope is that competition and oversight will create a more level playing field by keeping certification costs down and reducing the barriers to market entry.

Innovation as a theme and goal going forward, backed by the White House One of the most unexpected, but also most promising, twists in 2009 was Aneesh Chopra's arrival into the fray, with support from the new Chief Technical Officer for HHS, Todd Park, the former co-founder of web-based practice management software company AthenaHealth. Aneesh holds the title of first Chief Technical Officer of the United States. A known innovator and proponent of off-the-shelf and open source software, Chopra was previously Virginia's Secretary of Technology.

Chopra sits on the ONC advisory HIT Standards Committee, where late this year he formed an Implementations Workgroup. That effort breathed much needed fresh air into the smoky backrooms atmosphere of the HIT Standards Committee, which had effectively blocked entry of innovative and start-up firms into the EHR technology market by recommending a set of untested, complex, and large enterprise-centric standards.

Apparently recognizing that these were unimplementable, Chopra's work group held a day of hearings that solicited advice on what does and doesn't work with respect to standards from - imagine this! - experts with proven track records outside of the health care industry. We don't yet know the results of this last minute counterbalance to the incumbent and legacy vendors' influence on ONC. But even some of the most entrenched people on the HIT Standards Committee are now blogging on their ideas for the "Health Internet," a term quietly replacing the older National Health Information Network. This is good news.

The Power Shift Away from Legacy HIT Firms

Physicians, particularly those whose practices are owned by hospitals, will continue to purchase legacy EHR systems. But there are now alternatives, supported by a grass roots movement towards modular, web-based, and much less expensive software for managing clinical work and information in medical practices.

We've called this emerging and disruptive innovation Clinical Groupware to differentiate it from the previous generation of EHR products. We're happy to report that there is new trade association on the scene, the Clinical Groupware Collaborative, with a mission to educate, promote, and organize collaboration among its members. It's existence is simply one indication that Web-based applications and software-as-a-service (SAAS) is finally arriving in health care.

This new health IT paradigm is being aided by the phenomenal success of Apple's iPhone and apps store (2 billion downloads, more than 100,000 apps) and a chorus of technologists, politicians, and public commenters who are asking why a similar platform + modular apps approach hasn't gained more acceptance in health care among physicians and hospitals.

Interest in HIT by Big Technology Companies

The convergence of the opportunities in health care and the race toward cloud computing isn't lost on the largest Web firms. Organizations like Microsoft, Google, Salesforce, Covisint, IBM, Intel, and Amazon not only are marshaling their forces to create new health care products, but have the resource bases and very deep IT infrastructures required to rapidly scale the kind of effort that will be required in a sector as vast and sophisticated as health care.

Their emergence in this space presents a non-traditional challenge to legacy firms, which have typically faced and easily out-gunned smaller, less resource-capable innovators. These new entrants are extremely sophisticated, established businesses with enormous capitalization and, often, more leading edge technologies.

These unexpected turns of events are profoundly important for a simple reason. The changes in health information technologies over the next few years could well be foundational, shaping how health care works globally for the next several decades. Which is why it is imperative that we not allow older paradigms that have outlived their utility to prevail, just because they were there first. 2009 has been a bright spot, in the sense that we've seen signs that the old guard could be dislodged. Against a backdrop of a health care reform effort that, as far as we can understand it, will not do much to improve the system, this progress in Health IT is encouraging.

David C. Kibbe, MD, MBA and Brian Klepper, PhD write together about health care market dynamics, technology, and innovation. Their collected works are here.

The NHIN and the Health Internet: A Matter of Control, Cost and Timing

2009-11-19T10:51:00.000-05:00

By DAVID C. KIBBE and BRIAN KLEPPER

There is growing tension within the Obama administration's health team over who will control health data exchange: everyone (including consumers and their doctors), or just large provider organizations. The public debate will be framed in terms of privacy, security, and the adequacy of current exchange standards. But what really matters is who gets to make decisions about where health data resides, how it can be accessed, how much exchange will cost, and how long it will take for exchange to become routine.

Now is a good time to re-visit the plans for a National Health Information Network (NHIN), since we can finally observe and compare different health data sharing and exchange models in the marketplace. NHINs represent an older model that tries to use regional health information organizations (RHIOs) to establish secure networks, privately owned and operated by large provider organizations, mostly hospitals and health systems. The idea was that, over time, each private regional network would develop a gateway to other networks, creating a "network of networks" that would allow Stanford to talk to Partners Health, or Kaiser to Mayo. This communications model was enterprise/provider-centric. Patients/consumers were relegated to depending upon each RHIO's policies for access to their health information. It was also a massively expensive and time consuming - think decades - way to build a health data network.

Suppose a RHIO is in your area. Your health data from hospitals, outpatient clinics, and other settings associated with Health System A, are collected and combined with health data stored in similar settings in Health System B. Possibly Health Systems C, D, and E have also collaborated with A and B in this RHIO. Most RHIOs have cost or will cost many millions of dollars to build and operate. They were greatly encouraged by the Office of the National Coordinator under the Bush Administration, and have received additional support and funding under the ARRA/HITECH provisions that establish Health Information Exchanges (HIEs). They generally create large database management systems housed in large data centers. They typically run on proprietary software, creating closed networks that may or may not permit access onto and off the Internet.

As an individual, you probably don't have direct access to the RHIO data; only doctors and nurses are authorized to access your information. In most RHIOs, if you request access to your health information you must make the request the same way you would to your physician's medical practice, and often you will receive the results on paper. Transfer of these medical records to another institution or to a new provider outside the RHIO is not possible in most cases, although some RHIOs and HIEs now permit patient accounts and viewing of selected data.

By contrast, the Health Internet is a more current model, centered on the patient/consumer. As the name implies, the Health Internet leverages the Web's physical network and its open protocols and standards for health data exchange controlled by patients (and/or patient agents, like doctors, through authorized web services). The idea is to develop mechanisms that allow health information to pass easily across institutional and business boundaries, to anywhere it's needed. The Health Internet builds on the same Internet infrastructure and conventions that under-gird the transactions of major industry sectors like banking, e-commerce, retail sales, home mortgage business, and media and entertainment. Because this infrastructure is largely already in place, although little-used by health care entities now, the Health Internet could grow and scale rapidly at very little cost.

You can already see how the Health Internet is developing. You go to a CVS MinuteClinic, or to a handful of doctors, hospitals, labs, or pharmacies that offer you a personal health record account that lets you transfer your data in machine-readable format at will. You also create a Google Health account (or Microsoft HealthVault, Keas, or any number of personal health record platform websites) which allows you to upload your machine-readable, structured health data to them.

Next, you give your Google Health account permission to transfer your summary health data: to a doctor in anticipation of a visit; to a family member who is helping look after you; to a service that offers decision-support based on your information to help you solve some of your health/wellness problems; or to a service that will organize your health data into folders categorized by date, or provider, or episode of illness. The important thing here is that you, the individual, are deciding when, why, and where your health information is going.

The Health Internet example we've described above is performing the foundational transactions required of a national health information exchange network, and is doing so today. There are many examples, and they are growing organically, without government support, without new and complex standards, and at very low cost.

Even so, the Health Internet's growth is constrained mainly by the limited data available to patients and consumers from their doctors and hospitals, who continue to resist the idea that individuals ought to control their own data. They are also inhibited by patients' reluctance to challenge their doctors and hospitals on this point.

These and other barriers also make the Health Internet an imperfect solution to the goals of secure and efficient interoperable health data transfer. For example, current coding and classification systems remain a complex stumbling block to any model of health data exchange. Various coding systems are in use. Some are proprietary and require pay-for-use, and others need to be extended and gain industry consensus to be truly useful.

But it is no coincidence that the British government is investigating using both Google Health and Microsoft HealthVault for personal health data exchange, moving away from its own National Health Service program, after the latter spent billions on a national information network that doesn't appear to work. The NHIN "network of networks" model in this country is beginning to flounder, too, and may never achieve its future potential as a national system. The reasons are partly political, economic, and technological. An NHIN system's triple burdens - smoothing over competitive markets, enormous cost, and proprietary complexity - created so that large systems like the VA and the DOD, Kaiser and Geisinger, can exchange data without having to reach the Internet, will likely sink this ship even before the British program runs aground.

The Health Internet, on the other hand, has the obvious advantage of not "re-inventing the wheel." As former Intel CEO Craig Barrett famously said, "We already have a network for health data, it's called the Internet." Proponents of the Health Internet argue that, while health data and privacy and security are very important, the data themselves are inherently no different from financial data or the kinds of personal information routinely -- and very securely -- transported over the Internet using fair market encryption and other security technologies to protect it from intrusion, capture, or breach. So why go backwards to create the equivalent of Prodigy or AOL in every state? It could take forever.

We want to give credit to David Blumenthal, the Obama health team members and the folks at HHS who are taking a hard look at how best to create a secure and efficient method for health data transfer in this country.

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

Will Business Force Reform Back to the Drawing Board

2009-11-13T10:46:00.000-05:00

By BRIAN KLEPPER and DAVID C. KIBBE

Until now, non-health care business has been noticeably absent from the health care reform proceedings , and quiet about the bills' impacts on their management of employee benefits, on cost, and on the larger issues of global competitiveness. Where have the voices been of the powerful business leaders who will pick up much of the tab?

They've finally surfaced, and now we'll see whether they have the will to bring reform back on track. They certainly have the strength. The question is whether this salvo by the business mainstream could force Democrats to reconsider and revise the content and structure of their proposals.

On October 29th, a powerful collaborative of major employer organizations sent a letter to Speaker Pelosi and Republican Leader Boehner asserting that the House legislation "falls short of the bipartisan goal of controlling costs and jeopardizes employer-sponsored coverage which now serves more than 160 million Americans." The same group sent a similar letter to Senate President Reid earlier that week.

It is important to note that the collaborative - the group includes the American Benefits Council, the Corporate Health Care Coalition, the ERISA Industry Committee, the U.S. Chamber of Commerce, the National Association of Manufacturers, the National Association of Wholesaler-Distributors, the National Coalition on Benefits, the National Retail Federation, the Retail Industry Leaders Association, the Business Roundtable and the National Business Group on Health - represents the mainstream of American business. In general, these associations' member firms have sponsored employee health coverage for decades, and understand the linkages between health, productivity, cost and competitiveness. Their very real stake in the outcome, their long term sponsorship and their sheer collective clout enable them to enter and change the terms of the discussion.

Then, Tuesday, Employee Benefit News published a list of 10 specific items prepared by National Business Group on Health President Helen Darling, a longstanding progressive voice in health benefits, that "should concern plan sponsors that provide health care benefits to their workers." The bill, she said:

Lacks meaningful ways to control health care costs;
Takes us down the road to even worse deficits and crushing national debt by not getting more savings from the health system and making the coverage more affordable;
Does not support strong evidence-based medicine or a way to make certain that we don’t pay for treatments that are not effective;
Does not establish a strong independent Commission that could help Congress make the politically hard, but obvious, good decisions to eliminate wasteful and harmful treatments and spending;
Does nothing to correct medical liability problems and related costly defensive medical practices;
Doesn’t expand employers’ ability to help employees to actively engage in wellness activities or achieve health goals;
Undermines ERISA and opens ERISA plans to unacceptable burdens;
Raises serious questions about the public plan and how it would operate;
Could require an employer who provides comprehensive benefits to still be subject to an 8% payroll tax if employees decline employer coverage because it costs more 12% of the employee’s income; and
Contains an outrageous requirement that would require employers still offering retiree medical coverage to continue it indefinitely, thereby hurting employers who have maintained retiree benefits in good faith.

Non-health care businesses comprise about six-sevenths of the economy - meaning they have six times the heft and influence of the health care industry - and financially sponsor coverage for more than half of Americans. Year after year, employers have borne the lion's share of onerous health care cost increases, 4 times general inflation over the last decade. Endless reports have described how health care, business' largest and most unpredictable benefit cost, has sapped America's global competitiveness and placed its employers at a severe disadvantage. An equal torrent of words has been spent on health care's excessive waste, at least 30% of our $2.6 trillion expenditure, or north of $800 billion annually. Even so, most business leaders are loathe to simply give up the health system they currently sponsor, its flaws notwithstanding, unless they can be confident the alternative can result in lower cost, improved quality, and an equally or more productive workforce.

Keep in mind that, at this point, health care reform has been a series of power plays between Congress and the health care industry (meaning the professionals, firms and associations representing health care's four major sectors: the supply chain, HIT, care delivery and insurance/finance).

Until now, the health care industry - those who seek dollars - has dominated, lobbying Congress and contributing enormous sums to election campaign coffers to make sure that the legislation doesn't impede health care profiteering and sends new funds their way. Meanwhile it has held its breath, apparently hoping that other interests with clout won't notice. As the bills come down to the wire, the air waves have NOT burned with cautionary and righteously indignant health care industry messages opposing them. That's because organizations in the health industry are reasonably certain they've won. They have been sitting tight until the deals are done.

And with good reason. As they stand now, the reform bills are very generous to the health care industry, facilitating, through mandate and/or subsidy, millions of new customers but, as we've recently pointed out, doing pathetically little to rectify the health care crisis' structural drivers. For example, the health plan sector can raise rates without restraint, and a significant chunk of Medicare dollars will be transferred to private sector control. The biotech industry gets a 12 year moratorium on generic competition. With only token progress away from fee-for-service reimbursement and toward primary care re-empowerment, the system will continue to make specialist excesses lucrative. The American Medical Association (AMA) and Medical Group Management Association (MGMA) couldn't be more enthusiastic, though both are now campaigning for H.R. 3961, which would eliminate the 21.2% drop in Medicare physician reimbursements scheduled to go into effect January 1, 2010. There are many more examples.

Commercial purchasers have waited to see how all this would play out. But now they're stirring, and not a moment too soon. Non-health care business leaders finally appear to be mobilizing against the weak cost control provisions of the current proposals.

What is needed now is an orchestrated, mobilized, highly visible campaign effort that features the faces and voices of well-known American CEOs, and that leverages the full force of business' leadership across industries, not just for their own interests, but for those of all Americans. The places to start are in the structural areas we and others have recently discussed: primary care, fee-for-service reimbursement and cost/quality performance transparency. Properly implemented, reforms in these approaches throughout health care could have profoundly positive impacts on both cost and quality, empowering the market to make health care far more affordable for businesses and working families.

It is possible that the entire health care reform process just changed tone and direction. If it did not, then we're no worse off than before. But if it did, then the ramifications for how American policy works - not just for health care but for all our issues - could have just entered a new and profoundly important paradigm.

Brian Klepper and David C. Kibbe write together on health care market dynamics, health IT, innovation and policy.

Saving Health Care, Saving America

2009-10-30T07:38:00.000-04:00

By BRIAN KLEPPER, DAVID C. KIBBE, ROBERT LASZEWSKI and ALAIN ENTHOVEN

So far, Congress' response to the health care crisis has been alarmingly disappointing in three ways. First, by willingly accepting enormous sums from health care special interests, our representatives have obligated themselves to their benefactors' interests rather than to those of the American people. More than 3,330 health care lobbyists - six for every member of Congress - contributed more than one-quarter of a billion dollars in the first and second quarters of 2009. A nearly equal amount has been contributed on this issue from non-health care organizations. This exchange of money prompted a Public Citizen lobbyist to comment, "A person can reach no other conclusion than this is a quid pro quo [this for that] activity."

Second, by carefully avoiding reforms of the practices that drive health care's enormous cost growth, Congress pretends to make meaningful change where little is contemplated. For example, current proposals would not rebuild our failing primary care capabilities, which other developed nations depend upon to maintain healthy people at half the cost of our specialist-dominated approach. They fail to advance the easy availability and understandability of information about care quality and costs, so purchasers still cannot identify which professionals and organizations are high or low performers, essential to allowing health care to finally work as a market. They do little to simplify the onerous burden associated with the administration of billing and collections. The proposals continue to favor fee-for-service reimbursement, which rewards the delivery of more products and services, independent of their appropriateness, rather than rewarding results. Policy makers overlook the importance of bipartisan proposals like the Wyden-Bennett Healthy Americans Act that uses the tax system to incentivize consumers to make wiser insurance purchases. And they all but ignore our unpredictable medical malpractice system, which nearly all doctors and hospital executives tell us unjustly encourages them to practice defensively.

Most distressing, the processes affecting health care reflect all policy-making. By allowing special interests to shape critically important policies, Congress no longer is able to address any of our most important national problems in the common interest - e.g., energy, the environment, education, poverty, productivity.

Over the last four years, a growing percentage of individual and corporate purchasers has become unable to afford coverage, and enrollment in commercial health plans has eroded substantially. Fewer enrollees mean fewer premium dollars available to buy health care products and services.

With diminished revenues, the industry is unilaterally advocating for universal coverage. This would provide robust new revenues. But they are opposing changes to the medical profiteering practices that result in excessive costs, and which often are the foundation of their current business models. And these two elements form the troublesome core of the current proposals.

Each proposal so far contemplates additional cost. But we shouldn’t have to spend more to fix health care. Within the industry's professional community, most experts agree that as much as one-third of all health care spending is wasted, meaning that a portion of at least $800 billion a year could be recovered. There is no mystery about where the most blatant waste is throughout the system, or how to restructure health care business practices to significantly reduce that waste.

Make no mistake. A failure to immediately address the deep drivers of the crisis will force the nation to pay a high price and then revisit the same issues in the near future. It is critical to restructure health care now, without delay, but in ways that serve the interests of the nation, not a particular industry.

Congress ultimately must be accountable to the American people. The American people must prevail on Congress to revise the current proposals, build on the lessons gleaned throughout the industry over the last 25 years, and directly address the structural flaws in our current system. True, most health industry groups will resist these efforts over the short term, but the result would be a more stable and sustainable health system, health care economy and national economy, outcomes that would benefit America's people, its businesses and even its health care sector.

Finally, the American people should demand that Congress revisit and revise the conflicted lobbying practices that have so corroded policymaking on virtually every important issue. Doing so would revitalize the American people's confidence in Congress, and would re-empower it to create thoughtful, innovative solutions to our national problems.

Brian Klepper is a health care analyst and industry advisor. David C. Kibbe is a family physician and a technology consultant to the industry. Robert Laszewski is a former senior health insurance executive and a health policy analyst. Alain Enthoven is Professor of Management (Emeritus) at the Stanford University Graduate School of Business.

A Message to America's Physicians: Purchasing EHR Technology: A Shaky State of Affairs

2009-10-28T00:56:00.001-04:00

October 28, 2009

By DAVID C. KIBBE AND BRIAN KLEPPER

Much of the conversation and debate about physician EHR adoption has centered on the single issue of the (high) cost of purchase. However, we'd like to suggest that the situation is much more complex and involves several more subtle variables.

Consider, for example, uncertainty about the future. In a recent speech, Lawrence Summers, Director of the White House's National Economic Council for President Barack Obama, related the following analysis about decision-making under conditions of uncertainty in the marketplace, which he had first heard from Ben Bernanke, current Chairman of the Federal Reserve, in a speech Mr. Bernanke gave over 30 years ago: "If you as a business were considering buying a new boiler, and if you knew the price of energy was going to be high, you would buy one kind of boiler. If you knew the price of energy was going to be low, you'd buy another kind of boiler. If you didn't know what the price of energy was going to be, but you thought you would know a year from now, you wouldn't buy any boiler at all. And in exactly that way, it is illustrated that the reduction of uncertainty, through the resolution of disputes, is, I would suggest, all important, if we are to maintain confidence."

Let us paraphrase both of these eminent economists, while applying the same set of ideas to the purchase of electronic health records: If you as a physician were considering buying a new EHR technology, and if you knew the reimbursement rates for your practice were going to be high, you would buy one kind of EHR. If you knew the rates of reimbursement were going to be low, you'd buy another kind of EHR. If you didn't know what the reimbursement rates were going to be, but you thought you would know a year from now, you wouldn't buy any EHR at all.

We've substituted "reimbursement rates" for the "cost of energy" here because, especially for physicians in small practices with under ten clinicians, the amounts they are paid per encounter by health plans, Medicare, and Medicaid are what determines how much money net of expenses will be available for significant investments such as EHRs at any given period of time.

And there is enormous economic uncertainty for physicians now. A 21 per cent cut in fees from Medicare is looming overhead, set to go into effect January 1, 2010. An arcane system known as the SGR determines annual Medicare payment rates by using a formula that aligns actual spending rates with specified targets. Medicare rates are crucial as they are the benchmark rates by which private sector health plans set their payment schedules. In the past several years, spending has exceeded targeted rates, triggering steep reductions in physician payment rates, which have been averted only by last minute Congressional intervention. What's worse is that recently the so-called "Medicare-fix" of the SGR has become a political football, with a Democrat-led effort to revamp the system as part of the health reform legislative package failing to reach the Senate floor for a vote on October 14, 2009. This only adds to the uncertainty regarding what physicians will earn in 2010 and beyond. No cut? A 5 per cent cut? A 21 per cent cut? The prudent physician or practice administrator, like the prudent business, would be wise to delay major purchases like an EHR until knowing if there will be capital available to pay for them.

Enter the ARRA/HITECH incentive payments of as much as $44,000 for "meaningful use of certified EHR technology" over a 5 year period starting in 2011, intended to stimulate physician and hospital adoption of EHR technology, uptake of which has been anemic at best. Currently, only somewhere between 15-20 per cent of physicians are using EHRs, and the number among small and medium size practices is even lower. Clearly, Congress and HHS believe that a stimulus of approximately $10,000 per doctor per year should be enough to induce a significant number of America's doctors to change their minds and acquire and use EHR technologies in their practices by 2015.

But only if the doctors can make a reasonable calculation as to the net costs of such a purchase, and right now there is too much uncertainty to make such a calculation. Not only do they not know the federal government's definition of a "certified EHR technology" -- which will determine which products currently on the market, or on the market sometime during 2010-2011, will qualify their practices for incentives, if purchased. They do not know yet which particular "meaningful uses" of such technology will be rewarded, if such a "certified" technology is purchased. They also don't know how to apply for the incentive payments, when to make such application, or in what time period to expect a reply. (To be fair to ONC and HHS, the regulations sorting all this out are expected to be released in December, 2009. However, as we understand the process, final versions are unlikely to be read into the Federal Register until mid-2010 or beyond.)

Furthermore, many physicians with whom we've spoken believe that the $44,000 being offered by the ARRA/HITECH incentives would cover only a quarter to a third of the actual total costs of ownership during those five years, leaving them with expenses of roughly an additional $100,000 per physician that must come out-of-pocket in order to implement one of these software programs. This may be why one hospital recently offered to add an additional $40,000 per physician, over and above the ARRA/HITECH payments, as incentive to get their system's doctors to utilize one of the more popular EHR products. ("Popular" may be a stretch. When only 15 per cent of doctors have chosen to acquire an EHR from any vendor, none of them can really be considered the people's choice.)

Thus, there exists a significant "uncertainty gap" between what Medicare or Medicaid is willing to pay a physician to adopt an EHR technology, and what the actual costs to each physician will be. Physicians buying now must either a) accept the possibility of a significant out-of-pocket expense, or b) have confidence that health care payment reform will provide significant additional payments beyond those of ARRA/HITECH to doctors will make up the difference. However, confidence among physicians in incentive payment programs from HHS and CMS is probably at an all time low. Many thousands of physicians who complied with the Physician Quality Reporting Initiative, or PQRI, by sending CMS quality and performance data from 2007 to 2009, have yet to receive a penny for their efforts. Some report they haven't even gotten responses from CMS as to the nature of the problems! The bonus payments are just 1.5-2.0 per cent of Medicare billings, or between $1,000 and $2,000 for the average family physician or general internist. But according to many physicians, the work that has to be done in order to qualify for these payments routinely uses nearly as much office staff and IT consulting work as the bonus is worth. The many snags encountered by physicians who have tried to participate in PQRI have added insult to injury, significantly tarnishing the reputation of CMS and putting into question, in the minds of many physicians at least, the government's ability to operate the ARRA/HITECH incentives, without question a much more complex endeavor than has been PQRI.

Finally, physicians lack confidence in broad payment reform of the kind that would actually create a return on investment for health IT used to improve quality and monitor costs of care. Beyond the issue of Medicare incentive payments for EHR technology not yet specified, to be used in ways that haven't yet been defined, doctors are manifestly not confident about the longer term issue of whether short-term incentive payments will be converted to sustainable economic returns, as through pay-for-performance, after 2015. This concern is perhaps more relevant to the reduction of uncertainty and the build-up of confidence than the narrow issue of ARRA/HITECH incentive payments, which are, after all is said and done, a faux business model for investments in EHR technology that comes to an end in 2015.

So, what should America's doctors do? Well, we're not in the business of advising people about how to spend their hard earned money. But we do believe that it's human nature to be conservative and to withhold investing when uncertainty about income, expenses, and returns on investments is high, and doubly so when confidence in the people and organizations making the decisions that effect those variables is low. That this is precisely the situation in which most doctors in America who work in small and medium size medical practices now find themselves may be more determinative about the future of the EHR market place and adoption of EHR products and services than any advice we could offer. This interplay of uncertainty, confidence, and money for health IT investments may also create challenges and give direction for Dr. Blumenthal and his staff at ONC as they operationalize the policy and regulations mandated by ARRA/HITECH. For one thing, as Ben Bernanke so wisely pointed out many years ago, resolving disputes will be key to ending uncertainty and returning confidence to this shaky state of affairs. But we're not sure that even Congress has the will to resolve the disputes that would set our health care system on a reasonable course and reduce the uncertainties we've discussed here.

David C. Kibbe MD MBA is a physician and Senior Advisor to the American Academy of Family Physicians. Brian Klepper, PhD is a health care analyst based in Atlantic Beach.

Why Standards Matter 2: Health IT Enters a New Era of Regulatory Control

2009-10-14T01:09:00.003-04:00

By DAVID C. KIBBE AND BRIAN KLEPPER

The recent history of electronic medical records in ambulatory care, or what we now call EHR (electronic health record) technology, can be divided roughly into three phases. Phase I, which lasted approximately 20 years, from about 1980 to the early 2000's, was an era of exploration and early adaptation of computers to outpatient medicine. It coincided with the availability of PCs that were cheap enough to be owned by many doctors, and with the increased capacity of off-the-shelf software programs, mainly spreadsheet and database management systems such as Lotus, Excel, Access, and Microsoft's SQL, to lend themselves to computerized capture of health data and information.

Phase II coincided roughly with the American Academy of Family Physician's (AAFP's) commitment to health IT as a core competency of the organization, and with its support/promotion of the early commercial vendors in the Partners for Patients program, a national educational campaign inaugurated in 2002 which involved joint venturing with vendors that included Practice Partners, MedicaLogic, eClinicalWorks, and eMDs, among others. Several other physician membership organizations joined this effort to popularize EMRs, or crafted their own education programs for their members based on the AAFP's model. The most popular Phase II products were, and still are for the most part, client-server software applications that run on local networks and PCs within the four walls of a practice, and tend to use very similar programming development tools, back-end databases, and support for peripherals such as printers. The industry grew, albeit sluggishly, from roughly 2002-present in an unregulated environment, with increasing support from quasi-official industry groups like HIMSS and CCHIT, and with the blessing of many professional organizations, including the AAFP, ACP, AOA, and the AAP. Best estimates are that the numbers of physicians using EHR technology from a commercial vendor roughly tripled during this period, from about 5% of physicians to about 15%. The Bush administration gave moral support to the industry, but did not provide funding or payment incentives, and mostly left the industry to itself to sort out the rules, including certification. The industry is now entering a new phase, one we predict will significantly depart from the previous two eras.

Phase III will be a time of government regulation of EHR technologies during which Congressional mandates -- sometimes quite vague -- will be interpreted by policy bodies within the government, which in turn will lead to federal rule-making and regulation as a means of carrying out policy goals and objectives. This will require significant interpretive work within the agencies delegated, mainly ONC and HHS, along with NIST and possibly the FDA and CDC, the results of which will have the potential to fundamentally alter the market for EHR technology and the products within that market, for many years to come.

Because there is a great deal of money at stake, Phase III will also be a period of intense competition, new and aggressive lobbying activity, and perhaps not just a few legal challenges, as winners emerge and losers fall by the wayside.

******

Why the revolutionary efforts to exert regulatory control over the market for EHR technologies in the US, and why now?

As we have listened to and participated in the meetings of the HIT Policy Committee and ONC staff, we have been struck by several things. First, the leadership are people who believe in principle in regulatory policy as a means of managing and improving upon the market. Secondly, they and their colleagues believe that the market for EHR technology has failed in several important respects, most notably by failing to create widespread adoption among physicians, medical practices and hospitals of even the most basic health IT tools, and by failing to institute interoperability of health data exchange, despite certifications that claim the opposite. And third, they have faith that regulations and rule-making are the means by which our nation's providers can be incentivized, and punished if necessary, into adopting the EHR technologies and associated standards that will set the stage for long term health care reforms in the payment system. In other words, they are committed to using the regulatory tools available to them to change the course and to move the curves of IT adoption in as short a time as possible.

Anyone present or listening by teleconference to the HIT Policy Committee meeting of July 14, which was devoted to the issue of EHR certification, had to have been impressed by both the directness and the force of the attack on the Commission for Certification of HIT, or CCHIT. It was relentless, and came from all quarters: from academic informaticists, from federal standards officials, from hospital CIOs, physicians in private practice, doctor membership organizations, and health care economics analysts. And, at the end of the day, CCHIT was stripped of its previously unchallenged prerogative to set certification criteria; removed of its monopoly for certification of EHRs; and left with large questions about even the validity of its role as advisor to ONC on the processes of certification.

The HIT Policy Committee recommended, and ONC has accepted its recommendations, that EHR technology certification criteria are henceforward to be decided not by CCHIT, an industry body with ties to the incumbent vendors, but by HHS and ONC directly. The term "HHS Certification" was coined and is now in use to indicate this change. Certification as a process will focus no longer on a long list of features and functions, but target Meaningful Use, interoperability, and security only. And, in the final insult to the industry and to CCHIT, ONC declared its intent to offer contracts to several entities to do the certification once criteria are set in early 2010, on a competitive bidding basis.

Thus, by the end of 2009, the industry that makes and sells EHR technology and into which will flow upwards of $30 billion in subsidies between 2010 and 2015, will receive a set of regulations that will specify the rules they must play by. There will be regulations defining Meaningful Use, others that regulate the process of HHS Certification of EHR technologies, and still others setting out the requirements physicians must fulfill to validate that they are meaningful users of certified products. Finally, the regulations will set the standards and protocols all parties must utilize in order to meet these definitions and processes, and especially with regards to computable (interoperable) data exchanges and the security of health data while in transit or stored in databases. This will be a complex new set of regulations unlike anything that the health IT industry has faced before -- although, of course, there are many other industries where regulatory control has played an important role in shaping major issues in the market, such as competition, pricing, and innovation.

*******

What should we expect, and how might these new regulations alter the EHR technology landscape?

In his most recent book, Supercapitalism, Robert Reich provides rich detail to support his contention that regulations rarely result in the public good being achieved, the claims of politicians and agency officials notwithstanding. Instead, the regulatory environment typically becomes the battleground upon which competing firms in a sector of the economy struggle to advantage themselves and disadvantage their competitors, whenever and however possible, most often through lobbying and influence peddling aimed at Congressmen and Senators, as well as at the regulators themselves. Regulations create regulatory disputes among competitors, each side claiming the moral high ground in whatever argument is in play, and often spending enormous sums on advertising, marketing, and lobbying firms, or on lawsuits intended to increase the value of their stock or to injure the reputation of their rivals.

These battles are well known and can be fierce, but they are new to health IT as an industry sector. A regulatory tussle that is current and attracting a lot of attention is the "Internet neutrality" debate. Discussions in Congress, at the FCC, and in the blogosphere revolve around the degree to which Internet Service Providers, ISPs, should be allowed to charge, or be prohibited from charging, different payment rates based on the content and origins of material presented in Web browsers attached to the Internet. The idea could be posed this way: Should local book stores be as easily accessible on the Internet, at the same speed of downloading, as large companies like Barnes and Nobles and Amazon.com? Or, should ISPs be permitted to charge large corporations higher fees to make their content arrive faster to customers' desktops and laptop computers?

Proponents of Internet neutrality argue that the federal government ought to regulate the industry to instill competition and protect the smaller companies, who may not be able to afford the higher prices easily affordable to Amazon.com, and in order to allow customers the greatest freedom of choice. But the larger companies argue that, by offering their bigger customers the opportunity to offer their own customers better service, the public interest is better served. They argue that to withhold the market's determination of how rates are set is inherently anti-competitive and against the long term interests of the consuming public, which they argue wants fast access to the most popular websites. Of course, they fail to mention that setting higher rates might also boost their own profits and increase the value to their own shareholders.

Vonage is an example of a company with a disruptive technology / business model that has actively engaged with the regulatory process in an effort to protect its business plan, while also being shaped by the regulatory framework. Initially, they weren't regulated like a phone company at all, and won a landmark case against the state of Minnesota, in which the FCC said Minnesota couldn't regulate them as a state telecommunications company, because their service -- voice over Internet protocol, or VoIP -- is inherently interstate in nature. At the same time, initially in response to consumer and legislative outrage that Vonage didn't provide 911 emergency service, the FCC has extended many telco regulations - including 911 regulations - to VoIP providers to ensure that Vonage and others can't circumvent many telco obligations and thereby gain a competitive advantage over traditional telcos. VoIP is now subject to 911 rules, Universal Service Fund obligations, many reporting requirements. So, in this case the regulatory framework initially favored competition and innovation, but was then changed to favor the incumbents. Many hundreds of millions of dollars have been spent by both sides in this long dispute.

Regardless of whose side you take in these kinds of debates, there are always going to be "winners" and "losers" when state or federal regulatory control is put into operation. And though we may like to think that the debates themselves are objective, free of undue influence by either side, in fact this is almost never the case. Large corporations have the money and other resources to lobby both Congress and regulatory bodies like the FCC, whereas consumers' interests or those of smaller and less well-heeled constituents are often unable to match the larger players' coffers. This is not to say that the side with the most money always wins. But as economist Robert Reich reminds us, the incumbents most often have and keep the upper hand.

*******

Although it is still early in the game, with the first issuance of regulations expected as a Notice of Proposed Rule Making (NPRM) in late December 2009, followed by a 60-day public comment period, the broad outlines of battles to come are now discernible. The incumbent health IT firms, mostly those such as Cerner and Epic whose growth and financial successes have been tied to large enterprise implementations, largely in hospital systems and large group medical practices, have vigorously put forward and defended a set of legacy standards that are complex, referential to other complex standards, not-well-suited to inter-organizational or personal data exchanges, and expensive to put into operation. They benefit from the promulgation and extension of these standards as regulatory mandates because, they say, this is the way to create stability in the industry. However, they fail to mention that these standards also advantage the older companies, as new entrants will have to expend significant time, energy, and money to acquire the expertise that these enterprise-friendly standards and protocols require, but which the incumbent vendors already possess.

But new entrants in the health IT economy, some very large and powerful, including both Microsoft and Google, along with a host of medium and small companies that gravitate around them like satellites circling large planets, have started to fight back. For example, Google's CEO, Eric Schmidt, has publicly criticized the Obama administration's current plans for subsidizing health IT and EHR technology use among physicians and hospitals. As a member of the prestigious President's Council on Science and Technology, he was quoted as warning that the ONC's plans threaten to lock the nation's health care system into the technological past, rather than launch it into the future. Google is not alone in wanting to see more of the nation's health IT infrastructure -- including physicians' practices and hospital systems -- move to Web services and so-called "cloud computing," in part because this is Google's strength as a company and where it hopes to make its profits in the coming years.

It's important that we end this piece on a positive note. The Blumenthal team at ONC, along with IT specialists at the White House and HHS, are in a listening mode, and the regulations are not yet finalized. Aneesh Chopra, White House CTO, has taken steps to open the discussion to include testimony for innovators, and to make innovation an explicit goal over at the HIT Standards Committee, of which he is a member. He and Todd Park, CIO for HHS, have recently announced that the direction of the Health Internet (formerly the NHIN) and its massive CONNECT gateway project will be re-focused to make secure access to and transfer of health data easier and under greater consumer control, using off-the-shelf standards and protocols wherever possible. When asked recently if these plans were endorsed by David Blumenthal, the response was an emphatic "yes," that the team in charge of health IT within the administration was working collaboratively under Dr. Blumenthal's express supervision. Perhaps even more importantly, these two and others are signaling that they want input from the experts, from the public, and from those who will be affected by the ARRA/HITECH programs. If you have an opinion about EHRs, PHRs, standards for health IT, or any other aspect of this new regulatory framework, now is the time to stand up and speak your mind.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians. Brian Klepper PhD is a health care analyst.

Will Republicans Be Spoilers or Problems Solvers in Health Care Reform?

2009-09-01T13:55:00.002-04:00

Will Republicans Be Spoilers Or Problem Solvers on Health Care Reform?

BRIAN KLEPPER and DAVID C. KIBBE

In theory Congress' return from recess next week could offer a new beginning to the health care reform process, giving everyone a chance to take a deep breath and recalibrate the components of change.

Nine months into the wrangling around a new Administration, the talk-show right has seemingly hijacked the discussion on health care, Democrats' signature issue, with the standard tools that demagogues have always used: leveraging popular prejudices with oversimplification, hyperbole, and distortion. The die-hard GOP faithful's leaders - Gingrich, Palin and others (see this off-the-deep-end speech by Rep. Mike Rogers (R-Mich)) - are of course playing spoilers, independent of the cost. They hope to goad centrist voters into abandoning the Democrats so they can retake power. Witness South Carolina Republican Jim DeMint's comment, "If we're able to defeat Obama on this, it will be his Waterloo. It will break him."

The problem with this approach is that we're still early on in our national discussion about change and about health care. An increasing number of Americans may be frustrated with Democrats, but after 10 years of Republican rule, few Americans see them as a party of fresh ideas or having an interest in helping anyone but the wealthy and powerful. Americans may have short memories, but they likely still recall that Republicans were just thrown out for a multitude of significant sins. So if everyone you know sends around Obama-as-Hitler arguments, heckling and hoping the Dems will quickly self-destruct may seem like a reasonable strategy. It is doubtful, however, that the other 75 percent of us buy into that thinking.

Of course, the Democrats' health care reform offerings haven't particularly helped. As we recently pointed out, now that they're in power the Democrats have taken enormous contributions from the industry, and their health care proposals show it, dramatically expanding entitlements but conspicuously doing little to drive out waste and cost.

This has alarmed some influential groups that otherwise might be supportive. For example, the non-partisan Committee for Economic Development, a business collaboration focused on social issues, issued this July 20th press release excoriating the bills:

"The House of Representatives and the Senate HELP Committee proposals are unacceptable. They would expand coverage without controlling costs, leaving future generations with a system even worse than what we have today. We cannot afford the government and the health-care system we have now, much less this bloated alternative. Lawmakers have bowed to political pressure at the expense of sensible policy. The business and policy community cannot stand behind these bills," said W. Bowman Cutter, Managing Director, Warburg Pincus.

And the Mayo Clinic, often cited by President Obama as a national model for higher quality, more efficient care, issued this strongly-worded response to the House Tri-Committee Bill:

Although there are some positive provisions in the current House Tri-Committee bill – including insurance for all and payment reform demonstration projects – the proposed legislation misses the opportunity to help create higher-quality, more affordable health care for patients. In fact, it will do the opposite.

In general, the proposals under discussion are not patient focused or results oriented. Lawmakers have failed to use a fundamental lever – a change in Medicare payment policy – to help drive necessary improvements in American health care. Unless legislators create payment systems that pay for good patient results at reasonable costs, the promise of transformation in American health care will wither. The real losers will be the citizens of the United States.

Over the weekend, Senator Mike Enzi (R-Wyoming), a staunch conservative and a member of the Senate's "Gang of Six" working on a health care bill, joined this chorus. He claimed that the Democrats' proposals "will actually make our nation's finances sicker without saving you money," would "raid Medicare" and intrude "in the relationship between a doctor and a patient."

It is important to distinguish this criticism from most of what we've previously heard from the right. Unlike many of his colleagues, and certainly contrary to conservative talking heads, Sen. Enzi's comments here are not so political as factual. They reflect the legitimate concerns of reasoning, mainstream conservatives who worry about simply throwing more money at health care without fixing anything.

Which constitutes the real health care reform opportunity for Republicans. The time could be right for centrist Republicans to pragmatically wrap their heads around this issue. After all, the approaches that are known to drive down costs and improve quality can easily be embraced by true conservatives who clamor for market-based solutions. Now, out of power and longing to demonstrate that they can produce substantive answers to our problems, the challenge will be to turn against their traditional industry benefactors and act on behalf of the American people.

On August 24th, Bob Laszewski posted an important column, There Will Not Be Health Care Reform in 2009 Without Republican Leadership, that listed four major areas of health care change that should come easily to centrist Republicans.

Bulletproof Health Care Security. This is the idea that everyone would have significantly improved access to care, that the employer-sponsored system would remain available for those who like it, and that Congress would be required to use the same system that they pass for the rest of us.
Medical Malpractice Reform. The Republicans have the Democrats where they want them on this one. There is no good reason why our current Med Mal system, as capricious and ineffectual as it has been, has not been revised with expert systems, except that the trial lawyers, in exchange for hefty financial support, have received protection from the Democrats. It's time to fix this problem that pervades our health care provider community.
Paying for It. This is acknowledging that subsidies will be required for those who can't afford health care at its current cost level, and that there are ways to structure the new cost that are more sensible. As Bob points out, the nearly forgotten Wyden-Bennett bill would be cost neutral in its second year.
Tough Cost Containment. As we said above, this has been the Congressional Democrats' proposals' most glaring and conflicted flaw. It is an area that, with a focus on primary care, paying for results instead of piecework, and cost/quality transparency, could dramatically drive down cost while improving quality, rightsizing our health system and going a long way toward ameliorating the most pernicious drag on our larger economy. Bob tackles cost control most effectively in his Health Care Affordability Model, a plan that would use tax incentives to encourage the industry to focus on driving out waste.

Collaborating with Democrats or, failing that, taking the lead to demand well-understood cost control mechanisms, would send a clear message that some Republicans are actually interested in problem-solving, not simply nay-saying.

It is possible that the health care reform issue has hardly begun, that the conventional back-room deals and horse-trading needed to be sorted through before the real work could begin. It is a profound truth that, town hall protests and nonsensical boasts about American health care notwithstanding, the middle class is terrified that their access to health care is slipping away. Both Democrats and Republicans have a large stake in visibly resolving this crisis. And, as Rahm Emanuel said, a crisis is a terrible thing to waste.

The shame and danger of the health care reform proposals so far is that they would likely do little to actually address the crisis. The question now is whether lawmakers in either or both parties can put aside their partisanship, their petty grievances, and their special interest conflicts to do the people's work. Pursuing the structural solutions described here would get America's health care system headed in a new, far more positive direction.

The American people are desperate for meaningful health care change, and are watching this process very closely. Whoever takes the high road and achieves real reforms will win. The opposite is also true.

Brian Klepper, PhD and David Kibbe MD MBA write together and consult on health care market dynamics, reform issues, and health IT. Their collected writings can be seen here.

Advice For State REC Planners

2009-08-31T13:53:00.000-04:00

By DAVID C. KIBBE & BRIAN KLEPPER

On August 20th, HHS Secretary Kathleen Sebelius and ONC head David Blumenthal announced $598 million in grants to set up about 70 "regional extension centers" (RECs) that will help physicians select and implement EHR technologies. Another $564 million will be dedicated to developing a nationwide system of health information networks.

The RECs are based on the example of agricultural extension offices, established over 100 years ago by Congress, which offered rural outreach and educational services across the country. These extension services made America's agricultural revolution possible, dramatically increasing farm productivity. By analogy, the Administration hopes that on-the-ground health IT trainers and implementation experts can facilitate small medical practices' adoption of EHR technologies, especially in rural and under-served areas, enhancing care quality and efficiency around the US.

The comparison between RECs and agricultural extension offices is probably a good one, and we applaud this effort. But there are some striking differences between agriculture and health IT. For one thing, many best farming practices were well known by the early days of agricultural extension services. The road map under ARRA/HITECH for successful small medical practice health IT acquisition and use is still under development, and remains full of tough questions and unknowns.

In fact, under Dr. Blumenthal's leadership, the government is now crafting specifications for Meaningful Use, HHS Certification, security, and interoperability. It's not yet clear what "meaningful use of certified EHR technology" means. So we could be in a cart-before-the-horse situation. It might be a little premature to set up technical assistance programs if we can't provide specific guidance on how to assist. Even fully CCHIT-certified comprehensive EHRs can't meet the Meaningful Use criteria today, so the REC's geek squads will have their work cut out for them.

However, a body of knowledge and experience already exists about successful health IT system implementation in small primary care and specialty practices. For several years, one of us (DCK) worked under the auspices of the American Academy of Family Physicians (AAFP), helping family physicians' practices prepare, select, implement, and maintain information technology offered by EMR and EHR vendors. The AAFP's current Center for HIT staff has expanded this effort, assembling an impressive body of resources and tools. It was augmented as well by the work of the Quality Improvement Organizations (QIOs) that participated in the Doctors Office Quality-Information Technology (DOQ-IT) programs between 2006-2008.

Some of this knowledge is anecdotal, and should certainly be revised in light of the definitions and specifications that the ONC will issue later this year and likely finalize by spring of 2010, according to Dr. Blumenthal. But the AAFP's and QIO's hard-won lessons may be useful to those who are planning the new effort.

Here's some broad guidance for state planners who are applying for these grants and who hope to set up their RECs by early 2010.

Keep your advisory services simple and targeted on solving actual problems. Hire people with hands-on medical practice experience, who will carefully listen to what physicians and practice managers want the EHR technology to do for them and their patients. Physicians in small practices generally will use EHRs in caring for patients and for managing office accounts. Overwhelming change won't be welcomed. Instead, focus on incremental implementations that try to solve information management problems without interrupting work flows.

Start with one system or workflow area, gaining success and then moving on to another. For example, some practices may be ready to implement ePrescribing, but are not ready to replace paper records with an electronic documentation system. Many practices have found that Web portals facilitating patient communications are a good EHR starting point, because they let doctors and patients exchange information online and asynchronously, easing telephone line congestion.

One size does not fit all. General IT skills are useful. New rules will soon specify how physicians and hospitals can qualify for the HITECH incentive payments and which products will be certified. Even so, there may be many different routes to successful EHR use. A flexible perspective is paramount. Favor advisers with generalized health IT system knowledge, rather than expertise with a particular vendor's product.

Some medical practices will choose a single-vendor EHR with all the added features, but others will mix and match modular applications that together create can minimum system capability needed for HITECH meaningful user status and incentive payments.

Similarly, some practices will prefer to locate data servers inside their practices or at the community hospital. Others will opt for Clinical Groupware, web-based and remote services EHR technologies that offer less hassle and expense for maintenance and security. Recognizing and differentiating between EHR technology offerings is going to be a major challenge for REC personnel in the near future.

Skate to where the puck will be. The old paradigm of health data management tried to collect a patient's complete data in a single database application, owned, maintained and controlled by a particular organization. However, throughout other disciplines, information management has become Web-centric and based on meta-data searches augmented by real-time communications and shared group activities. Think Wikipedia, Google docs, Microsoft Sharepoint, the Apple iPhone, and, yes, even Facebook, as representative of where health IT is migrating over the next few years.

Eric Schmidt, CEO of Google, and a member of the President's Council on Science and Technology, PCAST, recently urged President Obama and David Blumenthal to consider Web-based technologies as the basis of the national health information network. He warned that "the current national health IT system planned by the administration will result in hospitals and doctors using an outdated system of databases in what is becoming an increasingly Web-focused world. The approach will stifle innovation." Mr. Schmidt's advice, and similar advice from Craig Mundie of Microsoft, is coming from within the Administration, not from outside it. In other words, it's much more likely to be heeded than if were it coming from the opposition.

We hope that ONC's specifications, issued as guidance to the RECs by mid-2010, reflect market-driven innovations that can reduce the cost and complexity of EHR technology acquisition and use. Otherwise we're in for a national exercise in chaos.

Don't waste time re-inventing the wheel. Every REC should network with every other REC, regardless of location or stage of development, to share lessons and experience, and to avoid wasted effort. In the past, for example, regional helper organizations - some QIOs and medical societies - independently formed exclusive contracts with one or two EHRs vendors, hoping these arrangements would simplify choices and implementation. These proprietary relationships were invariably unsuccessful for the helper organization and for the practices.

Physicians and their organizations want to make health IT selections based on their own situations and needs. But almost always, they will seek the same kinds of IT support during implementation: e.g. networking, set up, Internet connectivity, security, and basic computer skills training for staff and physicians alike.

RECs should collaborate on tools and instruction kits where ever possible: each REC doesn't need to develop its own HIPAA privacy and security guide book, for instance. Remember that peripheral devices, such as printers, fax machines, and modems, are part of every office's set up, and that these items can be troublesome to set up and use.

Come to the task understanding that successful HIT implementation requires fundamental process re-design. We've learned this the hard way. Unless health IT helps re-design practice work and information flow processes so they can be more efficient and quality-promoting, then the IT is simply an expensive appliance. Process re-design also can determine whether the EHR technology deployment produces a return on investment (ROI). For example, re-designing the documentation process to reduce or eliminate dictation transcription services, relying instead on EHR data entry by office staff and the physicians themselves, can save money and lead to an ROI within 12-24 months. We have seen this occur frequently. On the other hand, practices that continue dictation at the old levels are simply adding new data capture expense, making it harder to justify the investment.

States are hurrying to get access to this stimulus money. Many organizations aspiring to be RECs are focused on the rapid grant/award cycles. But its critical for planners to focus on what it will take to get the job done, and setting the groundwork for effective regional centers that can offer thousands of practices the help they need.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on healthcare professional and consumer technologies. Brian Klepper PhD is a health care market analyst.

Health Care Reform's Deeper Problems

2009-08-27T10:24:00.000-04:00

By BRIAN KLEPPER AND DAVID C. KIBBE

Congress' health care reform debate has highlighted how American governance is broken and the difficulty of addressing our national problems.

Take, for example, whether health care is in crisis at all. Conservative commentators argue that America's health system is fine, that our excellent care simply costs more than other countries' poorer quality, and that most uninsureds can afford coverage. They ask why we should revamp a great system for the two or three percent of Americans who get less.

This misrepresents reality, though. Care and outcomes are often superior in other developed nations. In America, the ranks of the uninsured and under-insured have skyrocketed, from insurance costs that have grown four times general inflation for a decade. Health coverage is employers' most unpredictable major cost, a threat to their businesses' competitiveness, and they have increasingly offloaded costs onto employees. So while the marginalized uninsured are an important problem, declining coverage for the mainstream is the greater worry. Most know that, even with insurance, any major health problem can spell financial ruin.

As businesses and individuals have been priced out of health coverage over the last four years, commercial health plan enrollment has plummeted by as much as 20 percent, or about 36 million people. The Kaiser Family Foundation reports that 40 percent who lose group health coverage probably become uninsured.

Fewer people buying coverage means less money to pay for health care products and services, so the industry is experiencing an unprecedented financial decline. With reforms looming, it has fiercely advocated for universal coverage, which would provide stable funding for a larger patient population. Meanwhile, the industry has opposed changing business mechanisms that encourage waste, even though experts agree that one-third or more of all health care cost is unnecessary or inappropriate. But this raises an important question. Why not spend less by recovering wasted dollars, and then improve access?

The industry has pressed its goals through lobbying, which lets special interests exchange campaign contributions for policy influence. The non-partisan Center for Responsive Politics reports that, between January and June, the industry gave Congress more than $260 million. One lobbyist commented, "A person can reach no other conclusion than this is a quid pro quo [this for that] activity."

The funds have gone mostly to Democrats, the party in power now, and are producing their contributors' desired results. The current proposals expand coverage, but do little to reduce cost, failing to heed any of health care's management lessons from the last 25 years. For example, they won't re-empower primary care, which other nations have found will maintain a healthy populace for half the cost of our specialist-dominated approach. They fail to make care quality and cost transparent, which would let health care finally work as a market, and help identify the best health care vendors. They continue to favor fee-for-service reimbursement, which rewards delivering more products and services rather than rewarding results. And they all but ignore our capricious medical malpractice system, which most doctors say encourages defensive practice.

These problems and their solutions are structural, and are well understood within the industry. If reform does not pursue these structural approaches, health care will continue to drag down the larger economy. Our current problems will remain and intensify, at enormous cost.

Out of this experience, the American people should become aware of a couple of harsh truths.

First, so long as Congress willingly exchanges money for influence, American policy will favor special interests rather than the public interest. We'll be unable to meaningfully address our national problems: energy, the environment, education, and so on.

Second, so long as partisans distort the truth to discredit their opponents, rather than focusing on our very real problems, America's future will continue to be compromised.

Which is to say that we have deeper problems than an inability to fix health care.

Brian Klepper, PhD is a health care analyst based in Atlantic Beach. David C. Kibbe MD MBA is a physician and Senior Advisor to the American Academy of Family Physicians.

A Letter To The National Coordinator for Health IT

2009-08-13T07:19:00.003-04:00

The following is a letter sent by us and more than 20 prominent health care colleagues to Dr. David Blumenthal, the National Coordinator for Health Information Technology, within the US Department of Health and Human Services.

August 10, 2009

Dear Dr. Blumenthal:

We would like to request that the same exemplary openness, transparency, and support for innovation set by the HIT Policy Committee is followed by the HIT Standards Committee. We ask that the HIT Standards Committee support an evidence-based approach and open discourse about health IT standards and ensure again, as has been done so well thus far, that the results support innovators easily adding value to our health care system.

We applaud the work of the HIT Policy Committee to date. Just as it has been in the nation's best interests to re-open the EHR technology certification discussion in light of NIST's expertise and an international Conformity Assessment framework, it is in its interests to re-open the health IT standards discussion in light of recent experiences and market activity with health data exchange here and abroad.

While CCHIT and HITSP have accomplished some good work, both have been overly influenced by the same small group of special interests, and have created at least the appearance of conflicts of interest. Representatives from the legacy vendors, traditional health IT interests, and large health system enterprises have dominated the Health Information Technology Standards Panel (HITSP). A good example is HITSP’s June 2008 reorganization of its technical committees. Seventeen co-directors were announced for these six committees. Of the fourteen non-governmental co-directors, eight were current or recent employees of just three large pre-Internet enterprise vendors; three were from large vertically integrated delivery systems; and two were from large insurers. There were no co-chairs from emergent or potentially disruptive/innovative technology companies, or those with open source experience. No one representing Google, Apple, or Microsoft, for example. There were no practicing physicians and no patient advocates.

We are concerned because we hear from some of the people who are experienced in building successful standards in IT that the legacy standards largely promulgated by HITSP thus far will be a massive impediment to smaller more nimble innovators. It is very important that health IT standards not “lock out” the experience of other industries - e.g., financial services, e-commerce, and online publishing - which have evolved broad and deep Web-based infrastructures and marketplaces in which proprietary software and hardware are no longer prominent. In this case, it is vitally important to include the voices of the innovators in health care IT and data exchange, such as Microsoft and Google, Apple's iPhone, MinuteClinic and SureScripts, and their many partners.

At the very least, an evidence-based approach to health IT standards selection would consist of hearings to systematically review the best practices and lessons from health data exchange, particularly with respect to the uses of XML as a format and language for secure and interoperable transfers of summary health data like those contemplated as requirements under Meaningful Use by EHR technologies. The information distilled from this exercise could be placed alongside HITSP's conceptual constructs and enterprise use-cases. (In some instances, HITSP has recommended untested and unproven "standards" that experts have already questioned in terms of their suitability for real world implementation. Certainly, if ONC is considering translating these into national policy, they should be subject to full review in a public forum, followed by adequate testing.)

An evidence-based approach to standards selection would bring the innovators with actual experience to the discussion. An open forum would allow this testimony to help ONC's staff and the Committee members get a much better idea of what works, and what doesn't. This letter's signers and, we believe, others with deep field experience, would welcome the opportunity to testify and share their knowledge.

We understand ONC's and the Standards Committees' time pressures. On the other hand, an approach that ignores the evidence from the marketplace and practitioners outside health IT's "old guard," is simply a means of hurrying to failure, not marching to success. This is why we believe it is urgent that the discussion regarding health IT standards be re-opened immediately.

Thank you for your consideration.

Respectfully,

David C. Kibbe, MD MBA and Brian Klepper, PhD

Co-signatories:

Steve Adams, CEO, RMDNetworks, Inc.

Richard Benoit, Dossia

Edmund Billings, MD, CMO and EVP, Product Development, Medsphere

Warren Brennan, CEO, SMA Informatics, Richmond

Bill Crounse, M.D. Senior Director, Worldwide Health, Microsoft Corporation

"e-Patient Dave" deBronkart, Patient, Co-Chair, Society for Participatory Medicine

Michael Fleming, MD, FAAFP Chief Medical Officer Amedisys, Inc.

Sarah Greene, Managing Editor, Journal of Participatory Medicine

Alan Greene, MD, co-founder, DrGreene.com and President, Society for Participatory Medicine

Adrian Gropper MD, Chief Science Officer, MedCommons

James Allen Heywood, Chairman and Co-Founder, PatientsLikeMe

Stasia Kahn, MD, Founder, Physicians for Connectivity and General Internist, Fox Prarie Medical Group

Vince Kuraitis, Prinicpal, Better Health Technologies, LLC

Glenn Laffel, MD, PhD, Sr. VP Clinical Affairs Practice Fusion

Randall Oates, MD, President, SOAPware, Inc.

Martin Pellinat, CEO, VisionTree Software, Inc.

Rick Peters MD, President + CEO, Rocket Technology Labs, Inc.

Jane Sarasohn-Kahn, Principal, Think Health, Philadelphia

Tom Schwieterman, MD, Director of Research and Development, Midmark Corporation

Ravi Sharma, CEO, 4Medica

Rahul D. Singal MD, President and CEO, WorldDoc Inc.

Carl Taylor, Director, Center for Strategic Health Innovation

Mary Eleanor Wickersham, Director of Health Policy, GA Governor's Office, Atlanta

cc: Jonathan Perlin, MD, John Halamka, MD, John Glaser, Paul Egerman

Finally, A Reasonable Plan for Certification of EHR Technologies

2009-08-04T16:09:00.005-04:00

By DAVID C. KIBBE AND BRIAN KLEPPER
A caution to readers: This post is about methods for certifying Electronic Health Record (EHR) technologies used by physicians, medical practices, and hospitals who hope to qualify for federal incentive payments under the so-called HITECH portion of the American Recovery and Reinvestment Act (ARRA). It may not be as critical as the larger health care reform effort or as entertaining as Sarah Palin, but it WILL matter to hundreds of thousands of physicians, influencing how difficult or easily those in small and medium size practices acquire health IT. And indirectly for the foreseeable future, it could affect millions of American patients, their ability to securely access their medical records, and the safety, quality, and the cost of medical care.
Three weeks ago, on July 14-15, 2009, the ONC's Health IT Policy Committee held hearings in DC to review and consider changes to CCHIT's current certification process. The Policy Committee is one of two panels formed to advise the new National Coordinator for Health IT, David Blumenthal. In a session that was a model of open-mindedness and balance, the Committee heard from all perspectives: vendors, standards organizations, physician groups, and many others.
And then, on July 16, they released their final recommendations on what is now referred to as "HHS Certification." The effects of their recommendations - these are available online and should be read in their entirety to grasp their extent - are potentially monumental, and could very positively change health IT for the foreseeable future.
At the heart of these hearings was the issue of who will define the certification criteria and who will evaluate vendors' products. Among many others, we have voiced concerns that the Certification Commission for Health Information Technology (CCHIT), the body currently contracted by HHS to perform EHR certification, has been partial to traditional health IT vendors in defining the certification criteria, and in the ways certification is carried out, and thereby able to inhibit innovation in this industry sector. Despite its leaders' claims that the certification process has been developed using an open framework, CCHT's obvious ties to the old guard IT vendors have created an overwhelming appearance of conflict of interest. That appearance has not been refuted by CCHIT's resistance to and delays in implementing interoperability standards, or by its focus on features and functions over safety, security, and standards compliance.
In the hearings that led to the recommendations, longtime IT watchers were treated to some extraordinary commentary, much of which dramatically undermined CCHIT's position.
"HHS Certification means that a system is able to achieve government requirements for security, privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects...HHS Certification is not intended to be viewed as a 'seal of approval' or an indication of the benefits of one system over another."
In other words, as the definition of Meaningful Use is now tied to specific quality and safety improvements and cost savings that result from health IT -- among them e-Prescribing, quality and cost reporting, data exchange for care coordination, and patient access to summary health data -- HHS Certification will closely follow. Rather than pertain to an EHR's long list of features and functions, some of which have nothing to do with Meaningful Use, certification will be focused on each IT system's ability to enable practices and hospitals to collect, store, and exchange health data securely.
Who Determines the Certification Criteria
The Office of the National Coordinator - not CCHIT - would determine certification criteria, which "should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives." As regulator, funder for this project, and a major purchaser of health services, the government, not users or vendors, will now determine HHS' Certification criteria.
A New Emphasis on Interoperability
"Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit." That is, functions/features criteria will be broadly defined, but there will be a greater focus in the future on the specifics associated with bringing about straightforward data exchange.
Multiple Certifying Organizations
ONC would develop an accreditation process and select an organization to accredit certifying organizations, then allow multiple organizations to perform certification testing. In other words, the Committee recommended that CCHIT's monopoly end.
Third Party Validation
The "Validation" process would be redefined to prove that an EHR technology properly implemented and used by physician or hospital can perform the requirements of Meaningful Use. Self-attestation, along with reporting and audits performed by a Third Party, could be used to monitor the validation program.
Broader Interpretation of HHS Certification
HHS Certification would be broadly interpreted to include open source, modular, and non-vendor EHR and PHR technologies and their components.
These bold, forward-thinking proposals from the HIT Policy Committee have not been accepted yet. But in our opinion they should be. These measures would encourage new technologies to enter the market for physician medical practices seeking EHR technology, and wrest control away from the legacy health IT vendors that have maintained barriers and delayed adoption, so you can be sure that the old guard players are doing everything possible to have them rejected.
But these are hugely progressive steps in the right direction, toward allowing HIT to enable improvements in care and cost efficiencies that would be in the best interests of users and the public at large. If implemented, the changes recommended by the HIT Policy Committee would create greater choice, more standardization, lower price, less interruption of the practices -- as well as a check from CMS or Medicaid each year to help smooth the implementation, starting in 2011.

Why Congress Should Consider Bob Laszewski's Health Care Affordability Model

2009-07-09T16:19:00.000-04:00

BY BRIAN KLEPPER
Over the last few months, I have become increasingly disheartened over the prospects for meaningful health care reform.
First, the process is terribly conflicted, and it shows. In the first quarter of 2009, the Center for Responsive Politics reported that the health care industry contributed $128 million to Congress. Now that the tide has turned, this has gone mostly to Democrats who, as it turns out, are just as receptive as their Republican predecessors.
In turn, the Congressional health care reform proposals so far are mostly about coverage entitlements and access - fair enough - but despite cost containment rhetoric, they mostly ignore the ever rising cost burden that has brought health care to its knees. As longtime health care crusader Paul O'Neill pointed out in last weekend's NY Times, the proposals pay relatively little attention to adjusting the health system's structural flaws that encourage and tolerate tremendous waste and excess: fee-for-service reimbursement; a specialist-dominated medical paradigm; and a lack of enterprise-wide infrastructure that can facilitate transparency, transactional streamlining, and evidence-based decision-support. It appears we could be headed for Massachusetts-style health care reform, in which all the concessions will be made by the people paying the bills, and virtually none are borne by the health industry itself.
The health care waste that has been glossed-over in these proposals is monumental, the result of millions of premeditated decisions made by real people. Consider, for example, the MedPac report issued a couple weeks ago that found that physicians who own or lease imaging devices order images at twice the rate of physicians who do not have a financial stake in them. Or the fact that, even though the majority of claims are auto-adjudicated and we live in the age of electronic fund transfers, it takes health plans - which earn interest while they hold onto the funds - more than a month on average to pay a physician's practice and nearly two months to pay a health system. Or that many health plan brokers represent that they are independent consultants to employers, but steer their clients to health plans with whom they have a financial relationship.
There are literally thousands of examples like this tucked inside every health care sector: the supply chain, the IT sector, the care delivery system and the finance system. No one knows for sure what these excesses actually cost, but estimates vary between 30 percent ($800 billion) and 60 percent ($1.5 trillion) of our annual total health care expenditures. These are breathtaking numbers. We fork over these immense sums every year for services that provide little or no value.
In the process, we have eroded our national economic stability. The President and his health team have repeatedly noted that health care cost represents the single largest threat to the nation's long term financial viability. The savings that presumably would accrue from meaningful reform are key to the success of their larger economic plan.
The American people may not understand the technical issues, but they're also aware that the system is not working in their interests. In a recent NY Times/CBS poll, 72 percent of respondents - nearly 3 in 4 - said they favored "the government's offering everyone a government administered health insurance plan like Medicare that would compete with private health insurance plans." While I doubt that the rank-and-file of respondants understands what a public option would really mean, the deeper message seems clear: the current system is dreadfully broken and we need a different approach.
But the Democratic proposals seem oblivious to how crucial the issue is to the President or the American people. And so their focus has been on two seemingly extraneous issues.
First is whether the proposals' programmatic costs will come in at less than a trillion dollars over 10 years (rather than their long term impacts). Let's leave aside the fact that a trillion dollars is less than 40 percent of our annual health care expenditure at the moment.
Internally, the Congressional Budget Office and then Congress scores each proposal - the most recent version of the Affordable Health Choices Act from the Senate Health, Education, Labor and Pensions Committee (HELP) came in at $611.4 billion over 10 years - even though the evaluations may not consider ancillary deals made to win the buy-in of powerful health care lobbies, or financing that offloads costs onto some part of the private sector.
Still, if 30-60 percent of all current health care cost is waste, it is not clear why we should spend another $60 billion a year to improve the system. Why can't we recover and apply the wasted resources instead?
Second is whether the government offers a public option. This issue is worth a separate post, but suffice it to say that the cost growth of Medicare, a public option, has tracked closely with that of commercial health plans for 30 years. There is literally no evidence that the placing a program in the public domain - where it is highly susceptible to perverse influences like lobbying - is any guarantee of better performance.
In other words, one of the lessons of the last 50 years is that changing the financing model alone probably won't fix health care. What's needed - what is critical right now - are changes to the ways health care is supplied, tooled, delivered, managed and reimbursed, independent of any health plan's sponsorship and legal structure.
So far, our current round of reform has conspicuously dodged those issues, presumably at the industry's encouragement. The long term consequences of that avoidance, though, could prove disastrous.
*
One of the problems with taking on health care reform is that it is so complicated, with endless facets and special cases, and with stakes that are extraordinarily high. After all, we're tinkering with an economic sector that represents one dollar in seven and one job in eleven. There is a tendency to suggest that the health care marketplace IS the problem, and that we can solve problems through policy alone.
But the truth is that the marketplace has not been allowed to work in health care, or at least not in the classical sense. Government has financed about half of health care over the last several decades, distorting market functions. And the most powerful organizational forces in the market - physicians, hospitals, health plans, drug companies, device companies - have consistently lobbied against transparency of cost and quality information, the one ingredient that markets need to work effectively. The hope is that good policy both empowers market innovation and constrains its propensity for excess.
What is really needed in situations like these, though it rarely appears, is a fresh approach from an unimpeachably non-partisan and credible source. That approach must cut through complexity to get at the root of the problem, preferably with a relatively simple, easy-to-understand idea. I believe Bob Laszewski has provided us with this kind of solution.
There are many excellent writers and thinkers in health care, but I doubt many would object if I suggest that Bob Laszewski is at the very pinnacle of this group. His articles, written plainly and clearly, are a model of lucid, informed thought. A former health insurance executive, he has deep expertise in health care finance. A longtime DC health policy advisor, he has extensive connections with and is highly regarded within that community.
Bob has written a summary piece and a detailed piece about the Health Care Affordability Model. These posts should be as high on the required reading list for everyone involved in the national health policy reform discussion as Gawande's Cost Conundrum article was for the White House staff.
The Affordability Model posits a simple idea: Let's use tax incentives to align everyone's interest around driving out waste. If health plans and their health system partners hit targets, they keep their advantage. If they don't, they lose them. He then provides sufficient underlying detail to convince us that it is a workable plan for attacking one specific, important piece of the health care crisis: unrelenting cost growth. He states it like this:
The Health Care Affordability Model creates unavoidable incentives for health plans and their provider network partners to maintain their tax qualification:
The health plan would be placed at a substantial competitive disadvantage without it.
Doctors, hospitals, and other providers who were not in a tax qualified health care network would lose patients to networks that did control costs.
Employers and consumers would almost certainly purchase their health benefits only from qualified plans.
And, unlike most health care reform proposals, the Affordability Model would simultaneously reduce both public and private health care costs.

The Health Care Affordability Model is not a standalone health care reform proposal. It could be attached to virtually any health care reform plan now on the table.

There is nothing new about using tax incentives to shape individual and corporate behaviors. We have used them to encourage employers to purchase coverage for their employees, but we have not applied them to drive behavior within the health industry itself.

In my experience, most seasoned health care professionals have very good ideas about what will work and won't work, and what remedies can be applied to fix the current crisis. There isn't a lot of mystery about this. Empowered primary care, data aggregation and mining for transparency and decision support, some new genomic assays, new imaging procedures, face-to-face disease management, and many other approaches are known to work but have been under-utilized. As Bob notes, there simply hasn't been the reason to pursue these approaches.

We know, for example, that, when they're appropriate, minimally invasive surgeries are a grand slam. They dramatically reduce the pain associated with an invasive procedure. They have lower episodic costs. They're associated with fewer complications and nosocomial infections. And they produce quicker back-to-work times for workers. But we often pay surgeons less to do them, so we have created a perverse incentive to use the older, less positive approach. Under the Affordability Model, there would be a clear incentive for health plans, clinicians and everyone that supports them to change to the better, higher value approach.

To me, the real beauty of the Affordability Model is that it offers minimalist steerage. It implements a (relatively) simple, straightforward incentive, and then allows the market to innovate to achieve the desired results. It is as hands-off as possible, is likely to keep the best parts of our system intact and creates the impetus to drive out services that offer little value. It empowers the health care marketplace.

Who will be against Bob's proposal? Nearly everyone in the industry, because over time it will organically reduce revenues throughout the industry. But they ought to be for it, because it would stabilize health care, and at long last provide the sustainability that has been missing for so long.

Read Bob's piece closely, and you'll hear the passion he has infused into it. This is not simply a post, a suggestion. It is the distilled, highly focused advice of a top professional, offered to his country in a time of need. It is the summary wisdom of a life's work.

Congress has not adequately turned to the very pressing cost problem that Bob's model addresses. If it does not do so, the result will health care reform that is empty, meaningless and, ultimately, shameful.

My fervent hope, for all of us, is that they are listening with open minds, and that they have the courage to follow his advice.

A Dream of Reason

2009-06-23T07:02:00.002-04:00

By BRIAN KLEPPER and DAVID KIBBE

The dream of reason did not take power into account...Modern medicine is one of those extraordinary works of reason...But medicine is also a world of power.

-Paul Starr, The Social Transformation of American Medicine, 1984

Today's unveiling of a Declaration of Health Data Rights is an important action, long overdue, that represents a collaborative effort by a group of health care professionals - activists, entrepreneurs, technologists and clinicians - all colleagues we hold in high esteem.

The Declaration's several points arise from a single, simple premise: that patients own their own data, and that that ownership cannot be pre-empted by a professional or an institution. And there lies its power, especially in the context of early 21st Century health care. It is a transformative ideal that currently is not the norm. But we join our colleagues in declaring that it should be.

It is fair to note that this effort - making sure that all of us have immediate access to personal health information in easy-to-use (i.e., electronic or "computable”) format - is NOT the most important thing we need to achieve in health care right now. We all know that the system is wildly out of balance, with costs so excessive that even the insured mainstream of Americans risk financial ruin with a major health event, and quality that varies from superb to atrocious. Restoring a semblance of stability and sustainability to America's health system will require many measures that may not include an individual's right to control his/her own health information.

But it is an appropriate, critically necessary seed, nonetheless. Information withheld from patients, purchasers and professionals, wittingly or unwittingly, is the deepest root of America's health care crisis. Too often it is an act of power, enabling - and we use this word in the clinical sense - actions without accountability, and trumping the checks and balances that laws and markets strive for in progressive societies. There are many other roots to our current dilemma, of course, but nothing is as pernicious or corrosive as the lack of information transparency. It has been the practice in American health care for decades, with ramifications so grave that, by itself, it has placed the nation’s future in peril.

And so the right place to begin is with a straightforward statement that health information belongs first and foremost to patients. We hope that this seed will take root, that doctors around the country will erect a small poster in their waiting rooms saying "We support the Declaration of Health Data Rights."

And we also hope this event will spur a new sensibility about who owns information, about accountability, so that pricing and quality information on doctors, hospitals, health plans, drugs, devices, diagnostic procedures and treatments become freely available to health care patients and purchasers, so that absolute power is trumped and so Americans can have health care that is trustworthy, excellent and affordable, no matter where it is received.

Brian Klepper PhD is a health care market analyst and advisor to the industry. David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies.

Clinical Groupware: When Not-As-Good Is Actually Better

2009-06-20T16:58:00.002-04:00

By DAVID C. KIBBE

In a February 13, 2009 blog post I introduced the idea of Clinical Groupware as a low cost, modular, and cloud computing alternative to traditional electronic health record technology for physicians and medical practices. Central to the concept of Clinical Groupware is IT support for care coordination and continuity, achieved through shared access to personal care plans and point-of-care decision supports. In this post I'd like to put a few more ideas on the table, specifically with respect to the market niche that Clinical Groupware may ultimately fill, including comments by several individuals whose opinions or work may be crucial to the success of Clinical Groupware over the next 1-3 years. (Anything farther out than that is simply dreaming.) Consider this an interim report on an emerging story with an indefinite timeline.

Interest in this topic has been, of course, heightened by the recently passed federal AARA/HITECH, provisions of which will provide incentive payments to physicians of as much as $44,000 over a five year period commencing in 2011, provided that the physicians can demonstrate the "meaningful use" of "certified EHR technology." It's always more exciting when there's real money in the mix. Will Clinical Groupware qualify as "certified EHR technology?" Many physicians and developers are hoping it will. Here's why.

I see Clinical Groupware as a disruptive, low cost but high capability technology, an alternative to the costly EHR technologies that are now implemented in about 15-20% of ambulatory care settings; the rest of the market has not become consumers of these products. When 80% of potential customers aren't buying, one thing you can say for certain is that non-consumption is an important characteristic of that particular market. And that's what we have here. Doctors have taken a long look in the vendors' shop window and overwhelmingly decided that the combination of cost and performance characteristics offered there don't warrant a "buy now" decision.

Notice, there is no Apple iPhone adoption problem among doctors. To the extent that there does exist an "EHR adoption problem" for physicians, we should look to the characteristics of the products on the market for the sources of the problem, and not simply blame the purchasers out-of-hand. In my own experience most physicians are not Luddites, nor are they frightened by or confused by information technology in general. They purchase and use technologies they see as valuable to them and their patients, and that offer the performance characteristics they want at the price point they deem reasonable. It's just plain silly to get angry at physicians for being prudent shoppers. No one blames auto consumers for not having liked the Edsall or the Pontiac Aztek.

But this is all in retrospect. What's likely to happen in the future?

Of course no one can predict the future; all we have to go on is the past, and things don't always repeat themselves. But there is sound business theory based upon study and research over many decades, that can help us make educated guesses about future health IT product offerings, as well as about purchaser buying behavior. Clay Christensen, the noted Harvard Business School professor and author of several books on innovation, has described situations that favor the development of disruptive innovation in any industry. His ideas about change and innovation are worth a careful read:

The initial products and services in the original "plane of competition" are typically complicated and expensive, so that the only customers who can buy and use the products...are those with a lot of money and a lot of skill. In the computer industry, for example, mainframe computers made by companies like IBM comprised that original plane of competition from the 1950s through the 1970s... The same was true for much of the history of automobiles, telecommunications, printing, commercial and investment banking, beef processing, photography, steel making, and many, many other industries. The initial products and services were complicated and expensive.

Occasionally, however, a different type of innovation emerges in an industry -- a disruptive innovation. A disruptive innovation is not a breakthrough improvement. Instead of sustaining the traditional trajectory of improvement in the original plane of competition, the disruptor brings to the market a product or service that is actually not as good as those that the leading companies have been selling in their market. However, though they don't perform as well as the original products and services, disruptive innovations are simpler and more affordable. This allows them to take root in a simple, undemanding application, targeting customers who were previously non-consumers because they lacked the money or skill to buy and use the products sold in the original plane of competition. By competing on the basis of simplicity, affordability, and accessibility, these disruptions are able to establish a base of customers in an entirely different plane of competition...In contrast to traditional customers, these new users tend to be quite happy to have a product with limited capability or performance because it is infinitely better than their only alternative, which is nothing at all.

...When a disruptive technological enabler emerges, the leaders in the industry disparage and discourage it because with its orientation toward simplicity and accessibility, the disruption just isn't capable of solving the complicated problems that define the world in which the leading experts work. (The Innovator's Prescription, 2009, pgs. 5-6)

Is it accurate to compare the emerging Clinical Groupware with disruptive innovations in other industries, with the early PCs, the transistor radio, and Southwest Airlines, for example? Are we about to enter another "plane of competition" beyond the one that was established by EHR vendors like NextGen, GE Centricity, Epic, and Allscripts? And, perhaps most importantly, will the new EHR technology compete "on the basis of simplicity, affordability, and accessibility" with the older products in way's that establish "a new base of customers and disrupt the market?"

Well, one consistent sign of disruption is visible opposition and protectionism from companies who sell top tier products at the highest profit margins. And we are certainly seeing that! As reported in the Washington Post and elsewhere, the industry is attempting to raise barriers to new products characterized by simpler, more accessible, and less expensive EHR technology, mainly through regulatory control that would constrain the features and functions used to "certify" these products; through complex standards that make it more difficult for small companies to bring their products to market; and, most recently through state legislation that would ban non-certified products from being bought, sold, or used. (I understand that New Jersey state legislators with close ties to top tier vendors have introduced a bill that would make it illegal for anyone "to sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by CCHIT," and which would levy heavy fines on anyone who did. This would make it illegal, in effect, for Google Health or Microsoft HealthVault to operate in the state of New Jersey.)

But it is less the disparagement and discouragement to innovation, and more the enthusiasm and hopefulness attached to new health IT models, that indicates to me there may be a surge in popularity for Clinical Groupware during 2009 and 2010. A growing number of experienced engineers, technologists, patient advocates, and health professionals have indicated common support of the basic innovative ingredients in Clinical Groupware. These include: low cost, simplicity of use, interoperable modularity, software as a service, a focus on coordination, and engaged communications with patients and among providers. Here, for example, is Adam Bosworth of Keas, formerly Google VP in charge of Google Health, writing in a recent post on his blog:

...[M]ost small practices can’t really afford to use big iron EHR’s. Even if it is free, they can’t really afford to do it because it will still require training, more time per patient potentially, and so on. Lastly, most EHR’s don’t work with other EHR’s so that coordinated care across practices isn’t supported and most people who are elderly or who have serious illnesses have more than one physician treating them.

The way around this is to build systems that don’t just duplicate what physicians do today during their face to face meetings with their patients, but rather provide new capabilities that will help with continuous and coordinated care and can generate additive revenues for physicians and then evolve by adding those features that automate the current physician activities as demanded by the physicians.

What would such systems support? They would support having a way to chat with or exchange messages with a patient for a fee so that unnecessary office visits can be removed and the patient is more likely to reach out for help. Think eVisit-lite. They would support a simple way to monitor the health of a patient who either has a chronic disease or is on path to developing one, again for a fee, so that physicians are actually getting paid instead of punished for keeping their patients healthier since, ideally, healthier patients will generate fewer visits/procedures over time. In short these systems will support physicians managing an ongoing paid relationship with the patient rather than an episodic one measured only by in-office visits. What should be done about helping physicians who are afraid of losing time to retraining? These systems should be as easy to use as a Southwest airlines reservation page. These systems should have a cost so low that physicians don’t care. Most of these points aren’t typical of most of the big EHR’s currently being sold. Again, hence our fear that a de-facto monopoly of the incumbents will lose this opportunity to let 100 disruptive innovations flower. (May 29, 2009 http://adambosworth.net/)

Adam isn't the only one interested in letting "100 disruptions flower." Steve Downs and John Lumpkin at the prestigious Robert Wood Johnson Foundation NEJM editorial in late March, 2009. Downs and Lumpkin write -- their enthusiasm nearly jumping off the page -- in part: have recently blogged about the need to develop an "interoperable and substitutable web-platform" for EHR technology that is akin to the Apple iPhone apps model, an idea that is foundational to Clinical Groupware, and which was first described in detail by Ken Mandl and Isaac Kohane in a

Perhaps the key is to put more money behind companies that offer EHRs that allow 3rd party app development. Will seeding a fund convince other investors to get in? Are there startup ventures out there that could take advantage of the fund? A venture fund for app developers. Apple and Kleiner Perkins did this – they set up a $100 million fund to invest in companies that would develop applications for the iPhone. (June 4, 2009 http://www.thehealthcareblog.com/the_health_care_blog/2009/06/catalyzing-the-app-store-for-ehrs.html)

Meanwhile, over at ZDNet, noted business journalist Dana Blankenhorn is hopeful that David Blumenthal of ONC will come through as a supporter of innovation.

CCHIT changes its certification criteria every year, and every year it becomes more detailed. While the 2009-2010 standards have now been unveiled only 40 ambulatory EHRs have been approved under the 2008 standards, and only six are approved for emergency departments. By making all vendors jump through these hoops CCHIT imposes an enormous tax on all vendors and limits competition to those large enough to deal with it. What reformers ...seem to want is a more basic process, one that assures interoperability and encourages innovation. Placing that authority in the government instead of CCHIT does not guarantee this result, but it is certain CCHIT is not going down that road. What I expect to happen now is for the newly-appointed ONCHIT advisory committee to seek a compromise, and David Blumenthal will try to craft a solution that keeps all options open. (May 21, 2009 http://healthcare.zdnet.com/?p=2318)

Representatives from the medical specialty societies are also beginning to understand the value to their members of component-based EHR technology and software-as-a-service. For example, a senior team of researchers from the American Academy of Family Physicians, led by Paul Nutting at the University of Colorado Health Sciences Center, recently reported on initial lessons from 36 patient-centered medical homes. In their report in the May/June issue of Annals of Family Medicine, the authors highlighted as a common problem in medical home transformation the lack of a "plug-and-play" platform for EHR technology, and the slowness of response and high costs associated with some single-vendor EHR/EMR technology vendors. Among its findings and recommendations, the panel of authors stated:

...[I]t is possible and sometimes preferable to implement e-prescribing, local hospital system connections, evidence at the point of care, disease registries, and interactive patient Web portals without an EMR.

The AMA has just announced, in an appearance at the Microsoft Connected Health Conference, June 11, 2009, "..a new physician Web-based portal the AMA is developing ... will provide physicians access to practice-related products, services and resources in a single location. The AMA plans to launch its new portal nationally in early 2010." The platform will help physicians exchange health information with their patients through Microsoft's HealthVault application, and will include an ePrescribing module as well.

And then there are the open source folks. Fred Trotter, an expert in online security and a leader in the free and open source, FOSS, movement in health IT has recently discussed in his blog how momentum is growing towards a disruptive set of innovations:

The ‘Clinical Groupware‘ people want to see the certification of a suite of technologies that may or may not add up to a traditional EHR. The EMR-lite people want to see faster and lighter tools. The PHR people and consumer advocates want EHR systems that empower the patient instead of the provider. The Health 2.0 people want to see completely different models of finance and care become possible. Of course, the FOSS people (like me) want FOSS EHRs to get equal footing. (June 2, 2009 http://www.fredtrotter.com/2009/06/02/can-cchit-move-beyond-problem-ehr-certification/ )

One of the nice things about blogging is that people respond with their thoughts and opinions, and sometimes with new information that adds value to an idea, making it a collective -- rather than a merely personal -- concept. This is what appears to be happening with Clinical Groupware. I've received hundreds of emails and telephone calls from people who have connected the dots around this concept in their own way; most simply want me to listen to and understand their approach or, in some cases, discuss their innovative products. But a few commenters have asked the necessary, hard questions about what will make Clinical Groupware a successful disruptive innovation in a marketplace -- medical practice health IT -- that has been notoriously difficult, even fickle, to sell into. These questions, in turn, have forced me to think more deeply and to reach out to experts and innovators whom I trust to test the ideas.

Next week, at the 6th Annual Healthcare Unbound Conference in Seattle, I'll be moderating a panel on Clinical Groupware with a number of representative companies, and discussing their business models with the audience. Should be very interesting, and I hope to report back to you as developments warrant.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies.