Showing posts with label Health Information Technology. Show all posts
Showing posts with label Health Information Technology. Show all posts

Sunday, December 6, 2009

2009 a Year of Surprises and Change for the EHR Technology Market

2009 a Year of Surprises and Change for the EHR Technology Market

by DAVID C. KIBBE and BRIAN KLEPPER

"Oft expectation fails, and most oft there
Where most it promises; and oft it hits
Where hope is coldest, and despair most fits."
All's Well That Ends Well (II, i, 145-147)

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 are some 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 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 proving a true bright spot.

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

Tuesday, August 4, 2009

Finally, A Reasonable Plan for Certification of EHR Technologies

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 Americans 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.
  • Dr. William Stead from Vanderbilt recommended a narrow focus for certification on 'data liquidity' and solving the problem of health data exchange (i.e., interoperability) of summary health information. Dr. Stead supported the idea of separating the data from the applications, which we have written about in our blogs on several occasions.
  • Two very experienced Technology Standards professionals, Cita Furlani and Gordon Gillerman of the National Institute of Standards and Technology (NIST) laid out the international standards-based framework for Conformity Assessment, one small part of which is certification, testing for which is always performed by Third Parties. They pointed out that under this framework, Third Parties are by definition independent and unbiased, and required to not have financial interests in the outcomes of the certification process.
  • In more on-the-ground testimony, Paula Anthony, CIO at East Texas Regional Medical Center, described her organization's decision, after a multi-million dollar investment, to jettison one CCHIT-certified EHR product because it could not reliably and safely exchange data with another CCHIT-certified HIT product. If there was ever a succinct indictment of the failures of CCHIT, this was it, and everyone in the room knew it.
The recommendations released the day after the public sessions reflected these concerns. Among the Policy Committee's major recommendations:

A New Certification Definition
"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.

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. Brian Klepper PhD is a health care market analyst. Their collected collaborative columns may be found here.

Sunday, May 24, 2009

An Open Letter to the New National Coordinator for Health IT: Part 4 -- Bringing Patients into the Conversation About "Meaningful Use" of Health IT

by DAVID C. KIBBE and BRIAN KLEPPER

The Obama health team at HHS and ONC are gradually establishing the rules that will determine how approximately $34 billion in ARRA/HITECH funds are spent on health IT over the next several years. But there is a "missing link" in these deliberations that, so far, has not been addressed by Congress or the Administration: how the patient's voice can be "meaningfully used" in health IT.

After all, we, the taxpayers, will pay for all this hardware, software, and associated training. There are many more consumers of health care than doctors or health care professionals. Shouldn't we have a say in what matters - in what is meaningful - to us?

It may have been an oversight, but patients and consumers have been left very much on HITECH's sidelines. The attention and the money is squarely aimed at the health care providers - doctors, clinics, and hospitals. The Act's intention is to create "interoperable" electronic health records that, in the future, will be more accessible to them: doctors, clinics, and hospitals.

This is a policy that is tied unnecessarily to an outdated vision. It is provider-centered, paternalistic and top-down. But it could be re-imagined to take advantage of the new ways millions of consumers, patients, and care giving families are using information and communications technologies to solve problems, form online communities, and share information and knowledge.

We're moving more fully as a society into the Age of the Internet and, as the economist Jane Sarasohn-Kahn's landmark study The Wisdom of Patients compellingly showed, patients are far ahead of the health care industry in using it to advantage. Consider:
  • According to the latest Pew poll results "about half the public (49%) turned to the internet for information about the [swine flu] virus. Moreover, asked which news source had been most useful in this regard, 25% of respondents named the internet, putting it at the top of the list of information sources in terms of utility."
  • An earlier Pew poll showed that between 75% and 80% of American Internet users have looked online for health information, an estimate consistent with similar polling from Harris Interactive's 2009 data. 78% of home broadband users look online for health information.
  • Going online makes a difference in terms of decision-making, especially for e-patients with a chronic illness or a new diagnosis, according to Pew:
"For example, 75% of e-patients with a chronic condition say their last health search affected a decision about how to treat an illness or condition, compared with 55% of other e-patients. Newly diagnosed e-patients and those who have experienced a health crisis in the past year are also particularly tuned in: 59% say the information they found online led them to ask a doctor new questions or get a second opinion, compared with 48% of those who had not had a recent diagnosis or health crisis. Some 57% of recently challenged or diagnosed e-patients say they felt eager to share their new health or medical knowledge with others, compared with 45% of other e-patients."
  • The public appears ready to embrace shared online electronic medical record-keeping. A just-released joint NPR/Kaiser Family Foundation/Harvard School of Public report indicated not simply privacy concerns, but the strong conviction that this risk would be accompanied by the benefits of improved personal care and overall quality improvement.
  • The public also seems ready, as are some physicians, to use online methods to establish patient-physician relationships and provide care services. As David Kibbe recently reported on THCB, online care and consumers' familiarity with and use of tele-health is steadily expanding. American Well and TelaDoc, Google Health, Microsoft HealthVault and a rapidly growing number of companies are part of an evolving ecosystem that speaks directly to the interest of patients and health consumers to engage in many kinds of online health experiences.
  • The e-patient public is showing signs of engaging and even confronting established Medicine on the issue of access to their health data. A Google search on "e-patient Dave" yields almost 9,000 hits, the majority of these related to Dave deBronkart's revelation, covered extensively by the Boston Globe, the New York Times, and hundreds of blogs, that his hospital medical records were incomprehensible and often inaccurate. Dave, a kidney cancer survivor, had taken up the offer by Beth Israel Deaconess Medical Center's CIO, John Halamka, MD, of automated data transfer between the hospital's IT system and Dave's Google Health account. The good idea was to help Dave create a personal health summary at Google Health that could be refreshed by information from his doctors at BIDMC, and always be available to him as needed. Dave found, thought, that the hospital's IT system merely passed on billing diagnoses and codes, many of which were neither accurate nor up-to-date. The upshot: an apology from Halamka and BIDMC, a meeting with Google Health's team, and a change in policy at BIDMC. From now on, only physician-generated and reviewed diagnoses and problems will transfer to Google Health from BIDMC. This story of a modern day David representing e-patients versus a Goliath from the health care industry continues to reverberate in the industry and to have consequences for the future of personal health records.
So why not include health consumers and patients in the meaningful uses of health IT? Here's a short list of ideas about how to do this, provided in part by Don Kemper, the founder and CEO of HealthWise. We agree with his suggestions that "meaningful use" ought to include the routine practice of electronic communications with patients and care givers, starting with these five areas.
  1. Prevention and screening reminders. As appropriate, these should be shared along with a personal health plan and full access to one's records.
  2. Patient decision aids for major surgery and procedures. This might include messaging pre-and post-surgery to help avoid waits and delays.
  3. Patient instructions for acute and chronic conditions. What to do at home; what signs of problems or improvements to look for; when to call if symptoms develop or improvements don’t occur as expected.
  4. Guided self-management messaging for chronic conditions. Instructions in self monitoring, lifestyle, medications management, action plans, etc.
  5. Visit preparation for scheduled visits. This could include questions to ask the doctor or provider and biometric instructions, e.g. the need to fast before a test.
Let's ask the question another way: If the HITECH monies are spent on CCHIT certified EHRs that can't do any of these patient-centered tasks, or EHRs that don't come equipped with the features and functions to extend health IT capability to the patients and consumers, do we really think that the money will have been spent wisely?

But that's the pathway we seem headed down, led by the vendors. As Dire Straits once said, "money for nothing....those guys ain't dumb."

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. Brian Klepper PhD is a health care market analyst and a Founding Principal of Health 2.0 Advisors, Inc. Their collected collaborative columns, including the first 3 columns in this series, may be found here.

Tuesday, May 5, 2009

"An Open Letter to the New National Coordinator for Health IT: Part 3 -- Certification As The Elephant in Health IT's Living Room"

by DAVID C. KIBBE and BRIAN KLEPPER

In the first and second parts of this series we talked about how and why there is no universal definition for the term "EHR." Instead there is a legitimate, growing debate about the features and functions that "EHR technologies" should offer physicians seeking to qualify for HITECH incentive payments. We explored the layers of network technology, suggesting that federal regulators should "separate the data from the applications."

We also argued that there is much to learn from development platforms, recently and in the distant past, that have used standards to open the aperture of innovation. The best of these standards have reflected the experience of what works rather than specifying how to make it work. Defining the standards for data, devices, and network technologies too restrictively could choke off innovation, rendering HITECH's offerings whose expense and complexity are a barrier to, rather than an incentive for, adoption by physicians. Incoming National Coordinator for HIT David Blumenthal, MD seems to have been considering just this concern when he recently wrote:
"... [M]any certified EHRs are neither user-friendly nor designed to meet HITECH’s ambitious goal of improving quality and efficiency in the health care system. Tightening the certification process is a critical early challenge for ONCHIT."
We're not sure what "tightening the certification process" means. But if the new Administration hopes to entice physicians to embrace health IT, we'll need a different process entirely than the one developed through the Bush Administration's sole-source contract with the Commission on Certification for Health IT (CCHIT), an organization originally founded and staffed by HIMSS (The Health Information Management Systems Society) and dominated by large, legacy-based technology firms.

Concern about whether current certification process is fair and configured to promote the common interest is hardly isolated or out of the mainstream. Last week the Markle Foundation issued a report - both of us served on the panel that developed it, but there were also many representatives from prominent industry groups - with this comment:

A broader view of IT would seed innovation rather than lock in adoption of technology based on what is available today. Health information services and technologies need to innovate and evolve rapidly, as other sectors have transformed themselves by embracing and building upon the internet...To support meaningful use, HHS should endorse a simple specification for a minimal set of open technical standards for secure transport as well as a core set of data types. By creating an obvious and achievable starting place, HHS will enable many options for clinicians and consumers to retrieve and use information to accomplish the meaningful use objectives.

And in a slightly blunter and more acerbic assessment in a Healthcare Informatics interview, Intermountain Healthcare's CIO Mark Probst, newly appointed to the HIT Policy Committee formed by HITECH to advise the National Coordinator, said:
I mean it’s sure nice for Epic or Cerner or Eclipsys to tell their clientele that if they want to add new functions, you’ve got to go through them. So my guess is standards are somewhat threatening to them. Do we want 15 different gauges of railroad going around the United States or half the country driving on the left and half on the right? I mean you’ve got to have some standards if you want to get some of the benefits out of the systems.
*****

HITECH lists the following "meaningful uses" of EHR technology:
  1. The ability to do ePrescribing.
  2. Engagement in health information exchange to improve quality of care, e.g. care coordination.
  3. Reporting of quality and performance metrics, in a manner to be specified by the Secretary of HHS.
The common link between these three seemingly different uses of EHR technology is health data connectivity of health data to improve service quality.

E-Prescribing is essentially designed to promote care coordination between patients, doctors, and pharmacists. It uses EHR technology that is dedicated to exchange of data between physicians ordering medications, pharmacists who are filling these prescription orders, and patients who request refills and are dispensed medications for treatment of their conditions and diseases. All of these processes are easier, safer, more convenient, and less costly to perform using EHR technology than by paper or fax, and therefore we agree that this is a "meaningful use" of such technology.

Health information exchange between and among providers, especially when these providers are independent entities or exist in separate geographical locations, helps create continuity of patients' experience by providing continuity of information flow and access where once there were only isolated silos of health data. There is widespread belief that health data sharing could improve care, safety, and decrease waste and duplication.

And quality reports are, in essence, statistical analyses of patient experience, sorted across many different variables: e.g., condition, acuity, physician, location. Providers submit the raw data for analysis and feedback, another kind of care coordination and communication activity, although the results are removed in many cases from direct patient care. Here too, we see that this feedback holds significant potential for improving care and eliminating unnecessary costs.

As National Coordinator David Blumenthal has pointed out, the current CCHIT certified products were not designed for these purposes. And that begs several questions:
Should already certified products be de-certified unless they can demonstrate their ability to meet the new HITECH criteria of meaningful use?
  • What would health IT that was designed to carry out these tasks look like?
  • How might it be distributed and sold?
  • Should pricing criteria be included in the certification process?
  • How might it be able to accommodate new features and functions as these become desirable?
  • What tools do the nation's best performing groups provide to their staffs to empower them to provide high-quality and efficient care?
*****

A new certification process could be streamlined in ways that encourage rather than stifle innovation. Certifying entities should be neutral, dispelling the perception of many in the industry that CCHIT's ties to HIMSS are conflicted. (Note that we are not arguing for disbanding or dismissing CCHIT. We are simply suggesting that it should not have a monopoly over the specification of certification criteria. Like other organizations, CCHIT could choose to apply to become one of the certifying entities under the new process.)

Most importantly, the criteria for achieving certification should be closely linked to the "meaningful uses" specified by Congress in HITECH as ways physicians and hospitals can demonstrate improved performance associated with the tools, as justification for HITECH subsidies.

This could be easily achieved. ONC could interpret EHR technology as any software with the basic capability to create, protect (privacy and integrity), store, interpret, and exchange (i.e., import and export) a designated health data set, using existing, tested, and appropriate standards for this purpose. The designated health data set would be initiated with a small number of data elements that are already widely digitized and coded, such as problems and diagnoses, medication list and history, vital signs, and laboratory test results. Over time, and as exchange of this summary health data becomes routine, additional data elements could be added, as could new capabilities (e.g., decision support) for using the data.

Begin with a technological crawl, then walk, and eventually run. Build a platform capable of future extension beyond current transactions and technical specifications. Leave a lot of room for innovation.
*****
We believe that the market is moving inexorably to answer these questions, but that consideration of them by Dr. Blumenthal and ONC is a rare opportunity to accelerate the market response. By doing so, serious "new thinking" would likely be introduced into health IT. One of the consequences might be an entirely new process of qualification or certification of EHR technology from that currently proposed by HIMSS and CCHIT.

That "new thinking" would reflect the changes that have occurred in computing over the past few years since CCHIT defined EHR technology based on a client-server model that was dated even in 2004. For example, we have seen a major trend towards Internet-based applications, the so-called "cloud computing" revolution. In essence, this is the idea that one can access software applications as a service available over the Internet, instead of having to put the software programs on one's computer. Web-based software applications mean that customers need less specialized hardware and software to get more functionality at lower cost. Cloud computing allows us to make airline and hotel reservations over the Internet; to run word processing and spreadsheet applications, email, and contact database applications from a thin laptop computer or a cell phone; and to be free of dependence on particular devices or brands of hardware in order to participate in data exchange and communications.

A model of computing is emerging called Software as a Service, SaaS, in which the technology provides a platform into which multiple service applications can be "plugged" or "added" -- and often from competing companies that are also not the same as the company that owns the platform. Google Apps and the iPhone are the two primary examples of platforms that allow independent developers to create applications that can run on the platform, and in some cases interact with other applications. These applications may even be substitutable and be replaced by the user who is basing his/her choice of which app to use on the basis of pricing and value. Users of a Google home page can populate it with widgets (e.g. apps for weather, calendaring, email) from Yahoo.

Finally, the Internet and World Wide Web are increasingly being used as social media. From blogs, to Wikipedia, to Facebook and Twitter, online tools for communication and social interaction are transforming the way business is conducted and how society gets its information. Group efforts that used to require the filters of relatively rigid institutional structures, due primarily to the complexity of managing groups, are now as easy to organize as hitting the "Reply All" button on an email. We would guess that the number of physician exchanges taking place within Sermo and Ozmosis , two of the leading physician-based social networking sites, exceed by an order of magnitude the communications that take place through medical specialty societies taken all together. These new communications tools are creating unprecedented opportunities for people to express themselves, and medicine/health care is a primary cultural area being affected. People are regularly immersing themselves in virtual communities, like Patients Like Me or Diabetes Connect, organized around particular diseases; cyberspace is used to provide medical advice and visits with clinicians (see American Well or TelaDoc ); and more and more patients/consumer are expecting their doctors to have an online presence through web portals and secure communications channels.

By contrast, the CCHIT-certified EHRs are overwhelmingly practice- and physician-centric software applications that pre-date the Internet. They were not designed with participatory medicine or consumer-generated health care in mind.
Shedding the bloated feature set now required for certification in favor of a "thin certification" based on data exchange and management would immediately stimulate the health IT economy. It would also focus Congress' understanding of "meaningful uses" that it hopes will encourage health IT among physicians and hospitals. Opening the aperture for innovation might easily create new jobs for new EHR technology products and services in e-Prescribing, care coordination, health data exchanges, and quality/cost performance reporting.
*****

HITECH is hugely important because it is the Obama Administration's first major step toward health care reform. The stimulus funds for health IT aspire to lay in a modern national health IT foundation that can facilitate the better care at lower cost our nation so desperately needs.

If the process moves forward as it is currently configured, a not-for-profit agency that is dominated by industry interests and that promotes technology that is largely outdated will have succeeded through its policy influence in securing much of that funding while holding newer, less costly, better technologies at bay. If that occurs, it will not only be yet another serious compromise for American health care's future, but it will signal that other important elements of meaningful health care change - universal coverage, a re-empowerment of primary care, greater quality/cost transparency, paying for results instead of procedures - will be equally elusive.

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. Brian Klepper PhD is a health care market analyst and a Founding Principal of Health 2.0 Advisors, Inc. Their collected collaborative columns may be found here.

Thursday, April 16, 2009

"An Open Letter to the New National Coordinator for Health IT - Untying HITECH's Gordian Knot: Part 1"

An Open Letter to the New National Coordinator for Health IT - Untying HITECH's Gordian Knot: Part 1

by DAVID C. KIBBE and BRIAN KLEPPER

Congratulations to David Blumenthal on being named National Coordinator for Health Information Technology (ONCHIT). Dr. Blumenthal will be the person most responsible for the rules and distribution of the American Recovery and Reinvestment Act's (ARRA) nearly $20 billion allocation, referred to as HITECH, designated to support physician and hospital adoption of health information technologies that can improve care.

The job is fraught with difficulties, which Dr. Blumenthal has readily acknowledged. His recent New England Journal of Medicine (NEJM) Perspective, "Stimulating the Adoption of Health Information Technology," is a concise, clear and honest appraisal of two of these challenges, namely how to interpret and act upon the key terms used in the legislation, "meaningful use" and "certified EHR technology." Dr. Blumenthal gets to the heart of the matter by identifying the tasks on which the National Coordinator's success will most depend, and which will foster the greatest controversy.

The country needs Dr. Blumenthal to succeed. The issues are complex and, with huge ideological and financial stakes involved, politically charged.

Even so, we believe there are straightforward ways to help physicians and hospitals take advantage of this opportunity to use health IT to improve care. This article is the first of a series in which we'll try to disentangle the Gordian knot of inter-related issues embedded in HITECH. Below we identify six issues. Then we address the first.

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A defining paragraph in Dr. Blumenthal's NEJM article offers his vision of the problem:

....[M]uch will depend on the federal government’s skill in defining two critical terms: “certified EHR” and “meaningful use.” ONCHIT currently contracts with a private organization, the Certification Commission for Health Information Technology [CCHIT], to certify EHRs as having the basic capabilities the federal government believes they need. But many certified EHRs are neither user-friendly nor designed to meet HITECH’s ambitious goal of improving quality and efficiency in the health care system. Tightening the certification process is a critical early challenge for ONCHIT. Similarly, if EHRs are to catalyze quality improvement and cost control, physicians and hospitals will have to use them effectively. That means taking advantage of embedded clinical decision supports that help physicians take better care of their patients. By tying Medicare and Medicaid financial incentives to “meaningful use,” Congress has given the administration an important tool for motivating providers to take full advantage of EHRs, but if the requirements are set too high, many physicians and hospitals may rebel — petitioning Congress to change the law or just resigning themselves to forgoing incentives and accepting penalties. Finally, realizing the full potential of HIT depends in no small measure on changing the health care system’s overall payment incentives so that providers benefit from improving the quality and efficiency of the services they provide. Only then will they be motivated to take full advantage of the power of EHRs.

Here are issues that, to develop rules that can make the most of emerging Health IT trends, deserve clarification:

1. The term "electronic health record" (EHR) is unclear and imprecise, especially given the wide-ranging tools that can be used to manage health information in electronic format. Before developing rules that will guide our use of these tools, a clearer definition is essential.
2. In thinking about health IT, it is useful to separate health data from the applications used to manage health data. Separating them is critical to better understanding the role of standards, certification and the criteria used to validate physicians' and hospitals' claims on HITECH's incentive funds.
3. In a certification process, the appropriate scope of "basic [EHR] capabilities" should be limited to the critical few. Given constraints on time and resources and the "meaningful uses" that Congress wishes to promote, does it make sense to require a large package of features or a more limited set of basic capabilities?
4. How should the certification process be structured to ensure fairness, flexibility and openness to innovation? Does the current certification process meet these criteria?
5. The roles patients and consumers might play in any determination of "meaningful use" are important, but are left on HITECH's sidelines. How can health IT policy enhance the patient's health care experience and participation?
6. Will the incentive payments envisioned by HITECH actually encourage implementation of EHR technologies, and result in improvements in patient care quality? Or are better mechanisms available that can systemically improve care?

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1. Definitions
First, let's admit that there is no precise, universally-accepted meaning for "EHR."

The term sometimes refers to medical records themselves, digital files containing a person's health data and information. We believe this is what both Presidents Bush and Obama intended for the meaning when they have stated that all Americans should have their own electronic medical records. Individuals should be able to access their health information in electronic formats (of which there are many), and not just in paper records. Patients with their own EHRs can access them, give viewing permission to others, download them to computers or cell phones, and use software applications to manage and transfer the records in digital formats.

However, EHR may also mean a software application - like Intuit's Quicken for financial management or Microsoft Office for business productivity - used by doctors, nurses, and staff in a medical practice, hospital or other clinical setting. (EMR, for "electronic medical record," was an earlier term for this same class of software, now less used.) EHR software is typically utilized for creating, storing and managing a patient's care-related and billing data. Dr. Blumenthal uses this meaning in the passage above; EHRs are certifiable software programs that have "capabilities." We might also point out that EHR software for ambulatory care is very different from EHR software used in hospitals.

Unfortunately, many people have come to believe that a specific class of EHR software is required to consume and utilize the EHRs that are digital health records. But this is completely inaccurate. Many types of technologies can be used to manage digital records. If, for example, your electronic health record is a discharge summary written by a physician in Microsoft Word or PDF - two very common digital file format standards for text documents - you could use any number of word processing software programs to view that EHR, including some that are open source and/or free. Google Health, Microsoft HealthVault and WorldDoc store health records electronically for retrieval or updating by patients and the professionals or institutions that care for them. Even data that are digitally formatted in less publicly familiar standards, such as DICOM for radiological images and XML for structured medication or lab data, do not require an EHR application. Many types of software - personal health record applications (PHRs), image viewing programs, e-Prescribing applications, and even web browsers - can be used to create, consume, store, manage, and then transmit these data successfully. Each of these software programs, alone or in combination, deserves to be considered an EHR technology, by virtue of the fact that its main purpose is to handle electronic health records.

Further, the Certification Commission for Health Information Technology (CCHIT), initiated by the Health Information Management Systems Society (HIMSS), later re-organized as a non-profit and contracted by ONC while David Brailer was the the National Coordinator, insists that EHR software products must: a) include hundreds of features and functions, based on a model of such software that many would term "comprehensive," and; b) be supplied by a single vendor. This EHR definition prohibits CCHIT certification for many simpler, less feature-rich, and less expensive EHR applications. It also prevents end-users from assembling EHR software from components from separate vendors and submitting this for CCHIT certification.

The upshot is that the term "EHR" is no longer very useful. It creates more confusion than it resolves. This is more than a quibble. One can never be certain what EHR refers to: health data in electronic format; a technology that is designed to handle electronic health records in some fashion; an EHR software program that has fewer or different features and functions than those required by CCHIT, or one that has been assembled from compatible modules; or a CCHIT-certified, comprehensive software application from a single vendor whose product has been accepted by CCHIT.

It is not necessary to accept this confusion. Ever-expanding technological options, more than anything else, have made the term EHR obsolete. However, we think clarity is especially important now, as we face the challenge of setting rules to determine who will and will not qualify for ARRA/HITECH funding. If the language we use to define key terms is arbitrary, capricious, biased or simply out-of-date, the guidance we follow will fail to be fair or, more importantly, in our national best interest.

So, in an effort to reach the appropriate level of clarity, we suggest that "EHR technology" replace the terms EMR or EHR in ONCHIT's lexicon. The term would be defined as:

"An information technology tool, such as a software program or application, that is used to create, consume, manage or transport health data in electronic or digital form."

This definition is very broad, allowing many different kinds of technologies to qualify as meaningfully useful -- required by HHS and ONC -- and without requiring features and functions that are not useful. For the market to work and to encourage optimal innovation that can benefit all Americans, it is important to allow recognition and certification of single function applications that can mix-and-match with others, as well as more comprehensive packages, according to the needs, the budget, and customers' capacity to adopt. A first step is to create clarity in the language used to describe these tools.

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 and a Founding Principal of Health 2.0 Advisors, Inc.

Wednesday, March 4, 2009

"Five Recommendations for ONC Head Who Understands Health IT Innovation"

The team of David Kibbe and Brian Klepper are at it again with some advice on who best understands the health IT challenge in America:

Five Recommendations for ONC Head Who Understands Health IT Innovation


by DAVID KIBBE and BRIAN KLEPPER

Now that the legislative language of the HITECH Act -- the $20 billion health IT allocation within the economic stimulus package -- has been set, it's time to identify a National Coordinator (NC) for Health IT who can capably lead that office. As many now realize, the language of the bill can be ambiguous, requiring wise regulatory interpretation and execution to ensure that the money is spent well and that desired outcomes are achieved. Among other tasks, the NC will influence appointments to the new Health Information Technology (HIT) Policy and Standards Committees, refine the Electronic Health Record (EHR) technology certification process, and oversee how information exchange grants and provider incentive payments will be handled.

Previously we have described our concerns
with US health information technology and the policy agenda that has grown up around it. In the case of EHRs specifically, the tools that have been developed to date are often non-ergonomic, excessively costly, non-interoperable, and interruptive of practice work flows. They continue, in many cases, to use client-server rather than Web-based technologies, creating barriers to lower cost and easy data exchange. Most important, these issues are obstacles to the organic, market-driven development of a nationally compatible health IT platform. In large measure, they have resulted from the protectionist influence of powerful health IT firms whose interests would be best served by approaches that build on proprietary and pre-Internet health IT designs rather than upon innovation that would move health care closer to e-health.

We believe the key question for the Office of the National Coordinator (ONC), as the Secretary of HHS' principal Health IT adviser, is centered on whether and how health policy encourages innovation. Will the NC promote desperately-needed progress in the development, implementation and use of health IT, or constrain it under well-meaning but often over-zealous certification and standard setting? Will we buy innovative tools that let both providers and patients achieve better quality and lower cost, or buy yesterday's expert systems that resulted in our current problems? Will we facilitate and build on incremental solutions, or continue to delay action through endless expert panels, meetings, and rules-setting exercises?

The aperture of innovation can be opened much wider than it has been. Here are five individuals each of whom, we believe, as National Coordinator, would encourage innovation and change from the status quo. All of these people have demonstrated a vision of health care connectedness, quality, and efficiency that are in the common, rather than the special, interest, and each has the administrative skills and savvy to bring that vision to fruition.

Farzad Mostashari, MD MPH
Assistant Commissioner
Primary Care Information Project
New York City Department of Health
and Mental Hygiene

Dr. Mostashari chairs the Primary Care Information Taskforce, whose goal is to bring about the adoption of public health-oriented health information technology in underserved communities. He is a primary care physician with the unprecedented experience of having rolled out EHR technology to physicians and medical practices serving over 30 percent of New York City's Medicaid and underserved population. Among the largest and most successful EHR implementations in the country, this effort has included 1,500 public and private sector medical practices, rather than simply one large enterprise. An epidemiologist, Dr. Mostashari understands data and has the statistical expertise necessary for decision making at the individual, community, and population levels.

Dr. Mostashari has hard-won hands-on experience with implementing EHR technologies in the small and medium-sized medical practices that make up 75 percent of America's medical community, as well as knowledge that extends to public health and preventive services. He would bring a pragmatic vision of connected health for all Americans.

Carol Diamond, MD, MPH
Managing Director, Health Program
Markle Foundation

Dr. Diamond chairs Markle's Connecting for Health program, a public-private collaborative working to realize the full potential of information technology in health and health care. Among other significant achievements, she led the multi-year collaborative that produced the Common Framework for Networked Personal Health Information, the widely-endorsed (and current default) set of principles and practices that govern the exchange of personally identified health data among health care institutions, and between health care institutions and lay people. Dr. Diamond works with many private sector groups, government agencies, and health information technology bodies. She played a role with federal agencies and the health IT community in the development of www.KatrinaHealth.org, a secure web site that made prescription medication histories available to doctors and pharmacists caring for evacuees whose medical records were destroyed in the hurricane.

If the new NC must possess particular skills, it will be those of mediator and coalition builder. With a deep understanding of the challenges and opportunities ahead, Dr. Diamond has led national health IT collaboratives that actually produce results people, provider organizations, and health IT companies, can use.

Peter Basch, MD
Medical Director for Clinical Ambulatory Systems
Medstar Health System

Dr. Basch, DC area MedStar Health's medical director for e-Health, has been a leader in applying IT to the needs of physicians. An early EHR adopter in his own practice at MedStar Health, Dr. Basch now is directing EHR implemention throughout all of MedStar's ambulatory practices. He is a frequent writer, speaker and expert panelist on EHRs, interconnectivity, health care's transformation through IT, and the sustainable business case for information management and quality. Dr. Basch served as the chairman of the Maryland Task Force on EHRs that recently issued its final report. He has co-chaired the Physicians’ EHR Coalition, is a board member of the eHealth Initiative, and a member of the American College of Physicians’ Medical Informatics Subcommittee and Medical Services Committee.

With Dr. Basch, we'd get deep technical expertise, direct experience with implementation, credibility among practicing physicians and their membership organizations, an a voice that can represent primary care within large enterprises.

Carolyn M Clancy, MD
Director, Agency for Healthcare Research and Quality
Washington, DC

Prior to Dr. Clancy's appointment on February 5, 2003, Dr. Clancy was Director of the Agency's Center for Outcomes and Effectiveness Research (COER), then AHRQ's Acting Director. A general internist and health services researcher, she was a Henry J. Kaiser Family Foundation Fellow at the University of Pennsylvania. Before joining AHRQ in 1990, she also was an assistant professor in the Department of Internal Medicine at the Medical College of Virginia in Richmond. Dr. Clancy holds an academic appointment at George Washington University School of Medicine (Clinical Associate Professor, Department of Medicine) and serves as Senior Associate Editor, Health Services Research. She has served on multiple editorial boards (currently Annals of Family Medicine, American Journal of Medical Quality, and Medical Care Research and Review). Dr. Clancy has published widely in peer reviewed journals and has edited or contributed to seven books. She is a member of the Institute of Medicine and was elected a Master of the American College of Physicians in 2004. Few people in DC have the credibility and respect that Dr. Clancy deservedly enjoys.

Carolyn Clancy has grace, patience, vision, and deep knowledge of health care processes. She hung on at AHRQ throughout the Bush years, clear demonstration that she understands and can skillfully negotiate DC's landmines. And perhaps as well as anyone, she understands the opportunities that lie ahead for evidence-based medical care in the United States. That background would allow her to foster effective leadership and innovation throughout health care.

Adam Bosworth
CEO, Keas, Inc.
San Francisco, CA

Mr. Bosworth joined Google in July 2004, having left BEA Systems, and earlier, Microsoft. In early 2006, he gained widespread attention as being "architect, Google Health." Bosworth is widely recognized as a pioneer and key figure in the evolution of extensible markup language, or XML, the standard upon which e-commerce most depends. Bosworth was a senior manager at Microsoft, where he drove the company's XML program from 1997 through 1999. He was then named General Manager of Microsoft's WebData organization, a team focused on refining the company's long-term XML strategy. While at Microsoft, he was also responsible for designing and delivering the Microsoft Access PC Database product, and he managed the development of the HTML engine used in Internet Explorer 4 and Internet Explorer 5. He is one of the most successful software engineers of the past 25 years, chief product manager for numerous well-known products that have changed our every day world, including Internet Explorer, Microsoft Access, extensible markup language XML, and Google Health's Personal Health Record.

Over the last couple years, Mr. Bosworth has impressed health care audiences with the scope of his knowledge and vision for how more broadly conceived health IT could positively shape the supply, delivery and financing of health care. An outside-the-box candidate par excellence, he has complete fluency in how software and standards for data exchange work. Although relatively new to the health care sector (compared with our other recommended candidates), Mr. Bosworth's unparalleled technical expertise, history of consistent innovation, and his fresh approach to health care's structural problems might be just the infusion the industry needs.

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 and a Founding Principal of Health 2.0 Advisors, Inc.

Wednesday, February 11, 2009

Health Care Reform--The Stimulus PreGame

"Drug Makers Fight Stimulus Provision"
"Lobbying War Ensues Over Digital Data"

The first was a recent Wall Street Journal headline and the second headline comes from the Washington Post. Both refer to what were supposed to be two already agreed on health care reform ideas--comparative research about which treatments work best and the creation of a nationwide system of medical records.

The lesson here is that in health care nothing is easy, simple, or widely agreed to.

The stimulus bill will include about $20 billion for computerized medical records. The problem is privacy. Business interests want more ability to use health care data to market their products and identify people who can be treated more effectively--data mining for example. Privacy interests want tighter control of that data. Can a doctor or a hospital make money selling people's medical data? Could data ultimately be used to discriminate against people? Can drug companies pay doctors to send a letter to certain patients touting medications? Where does a system of information that could be used to alert patients to new treatments and used to track trends in health care effectiveness become at cross purposes with privacy?

This is not a new debate--a health information technology bill has been bottled up in the Congress for years over these kinds of issues.

Comparative research--which drugs or medical devices work the best--makes a lot of sense. That is especially true in the wake of decades of research that continues to point to wide overuse of technology as the primary cost driver in our health care system.

So you would think this one was a no-brainer. But wait. In the WSJ story, "The drug industry is mobilizing to gut a provision in the stimulus bill that would spend $1 billion on research comparing medical treatments, portraying it as the first step to government rationing." And you know, these guys never lose.

The rub for the drug and device industry is that this kind of research could actually be able to call balls and strikes--which treatments don't work well and therefore should have their use subordinated to those that work better. Already, in the Senate version the industry has been successful in getting language that added the word "clinical" which has the effect of having any studies avoid "bang for the buck" kinds of conclusions.

One billion dollars for comparative research but we aren't allowed to know which drug or device gives us the best return for our money?

And, these were supposed to be the easy parts of health care reform. I am again reminded of all the reports in recent months about how different the 2009 version of health care reform will be with the special interests really ready to cooperate.

Let me say it again, there is no consensus about just what any meaningful, or probably meaningless, health care reform bill will look like.

Can't wait for the main feature.

Thursday, January 22, 2009

Five "Shovel-Ready" Health Care Reforms

Five "Shovel-Ready" Health Care Reforms
By Brian Klepper & David C. Kibbe

Microsoft Health Vault's leader Peter Neupert has a wonderful blog post that makes two important points really well. One message is that health care reform is about the outcomes, not the technology. We should think expansively about which technologies to invest in, based on the results we want to get.

The other message is the economic stimulus package is different than the reform effort. It is moving at hyper-speed through Congress, and it may be difficult for staffers and other advisers to sort through and incorporate what may seem like opposing Health IT views against a backdrop of traditional ideology and extremely forceful special interest lobbying.

Even so, there's consistency among the health care professionals who worry about these issues all the time. Peter unexpectedly discovered that the messages of his fellow panelists from the Health Leadership Council, the National Quality Forum, the Permanente Federation and the General Accounting Office were remarkably in sync with his own testimony to the Senate Health, Education, Labor and Pensions Committee.

Congress is about to make some big moves in health care that will require immense resource expenditures but, depending on what we pay for, may or may not bear the fruits we hope for. They should move carefully. Not all health care reform has to be labyrinthine. Not all ideas must require huge cost or take years to come to fruition and gain market traction. There are relatively simple actions that are available now, and that the Obama Health Team could tackle to effect tremendously positive, immediate impacts on the system.

Of course, right now the Health IT industry is focused on the promise of a huge stimulus windfall that would be dedicated to their products. But the opportunities we describe below follow principles that have broad support among students of the health care crisis. Two would change the way we pay for health care services, tying payments to documented results. Three are based on how we pull together and make use of the data that can drive clinical and financial decisions, and they overlap, though not perfectly, in their potential. Still, if any system adjustments can be passed through policy initiatives that focus on what's best for the common rather than the special interests, these should be among the most straightforward.

Payment
Re-Empower Primary Care
There is general agreement that primary care is in crisis, the result of years of abuse and neglect by the medical establishment and by CMS. In simple terms, the primary care/specialist ratio in the US is 30/70. In all other developed nations, its about 70/30. And our costs are roughly double theirs.

We should allow primary care physicians to do the jobs they were trained for, changing their roles from "gatekeepers" to "patient advocates and guides." We should immediately start financially rewarding them for collaborating with specialists to manage patients throughout the full continuum of care. Keep in mind that, as the Dartmouth Atlas and other studies have made clear, most health care waste is concentrated in the sub-specialties and in inpatient settings, incentivized by a fee-for-service reimbursement system that rewards more procedures, independent of their utility. One very thoughtful approach to invigorating primary care has been advanced by Norbert Goldfield MD and colleagues.

Of course, truly re-empowering primary care will require more than just paying primary care physicians more. Higher reimbursements will help them afford to spend more time with each patient, yes, but PCPs also need help acquiring tools that can help them better manage those patients. And they need the authority to work collaboratively with specialists. Challenging, but certainly doable and important!

Changing America's current imbalance between primary and specialty care should drive significant downstream waste from the system, dramatically improving quality and reducing cost.

Increase the Incentives For Programs That Tie Payment To Outcomes
Projects like the CMS/Premier Hospital Quality Incentive Demonstration (HQID), in which 250 participating hospitals got 1-2 percent bonuses for achieving quality improvements, have clearly demonstrated that incentives work. The hospitals that pursued the incentives made greater strides in quality improvements than their peers who did not work toward the incentives.

But we need to make the financial incentives large enough to drive real paradigmatic change. Too many programs offer incentives that are trivial in the minds of providers. Does it make sense for physicians in small, busy practices to rework their office flows to try to meet the challenges associated with hitting targets in exchange for a 1 or 2 percent financial bump, tied to a fraction of their patient population?

Now that there's no question that incentives work, we could easily give these programs teeth by raising the incentive antes to 15 or 20 percent, while also demanding commensurate levels of savings. And we should go in, understanding that the goal is to drive out unnecessary care, and create expectations that, by managing better upfront, the total spend will be lower.

Data
Establish a National All-Payers Database
Data sets, including those comprised of health care claims, must be large to generate credibly useful information.

But health care is financed through many different payer streams and by many players within each stream. Nearly all treat their data as proprietary, and information remains fragmented. So, for example, physicians rarely receive useful information on their complete pool of diabetic patients: instead, they get small slices of data from each payer, each analyzed using a different proprietary methodology. Or, we fail to accumulate adequate sample sizes to identify which treatments, interventions, drugs, devices, health plans, physicians or facility services provide the best value.

But merging those data across payers and making the aggregated set freely available would create the basis to identify true evidence-based best clinical and administrative results. Based on hundreds of millions or billions of records, we might be able to credibly identify which professionals, services or approaches most consistently produce the best results within value parameters. The data set would always be building, providing an always slightly-new base for answering our most difficult questions. Together with the analytical tools that are also becoming stronger and more refined, the potential is vast.

Of course, health plans, always politically formidable, might fight tooth and nail to maintain the competitive advantage they believe is inherent in their data. But health care is a special enterprise, with objectives that are ultimately rooted in the common interest, so they have no real excuse to refuse this. And health plans, like the rest of us, would gain access to much larger data sets that can be mined to advantage.
There also are precedents here. Several states have already begun to establish all-payer databases. At a June 2008 meeting, a presentation on Maine's experience highlighted 3 fundamental, telling principles that are challenges to any effort.

1. Nobody wants to pay to develop and manage the database.
2. Nobody wants to contribute their data to the database.
3. Everyone wants the aggregated data that develops in the database.

The solution: make it a national effort, paid for by CMS, and with mandatory participation, user fees, and open access to the data.

Create Uniform Nationally Accessible Disease Registries
Many physicians have come to appreciate the value of disease registries. Registries allow clinicians to count all active patients with distinct conditions, e.g. hypertension or diabetes. They can track characteristics within a patient subset, e.g. diabetic patients on a particular medicine. They can monitor and stratify patient status and progress within each group, and generate reminders and alerts to assure guideline level care. And they can identify trends in performance and, with relative ease, get a sense of what works and what doesn't.

Even so, many registries are still in silos, meaning that the sample sizes remain small and that the parameters that define the registries' characteristics often vary between implementations.
What we need are freely available, Web-based registries with easy data entry and easy querying capabilities. The impact on our management of patients with chronic illness, who consume 70 percent of our health resources, would almost certainly be powerfully positive.

Release Medicare's Physician Data
Nearly a year and a half ago, the consumer advocacy organization Consumer Checkbook sued the US. Department of Health and Human Services (HHS) for the Medicare physician data in four states and DC. HHS argued that physicians have a right to privacy, even though, in the case of Medicare and Medicaid, they are vendors taking public dollars, and even though hospitals do not enjoy the same protection from scrutiny. In August 2007, the court held with Checkbook, and on the AMA's "advice," HHS promptly appealed, locking up the data for the duration of the Bush Administration.

The large commercial health plans have traditionally considered their claims data proprietary and so have not made their data sets publicly available. Self-funded health plans, administered by Third Party Administrators (TPAs), develop sizable data sets but have resisted collaborating, and have also not expressed an interest in making their data available.

So for those outside the health plan community, there are few, if any, data sources with sample sizes large enough to accurately evaluate and profile physician performance. This is significant, since studies have shown that there can be profound differences, 6x-8x, in resource consumption (i.e., cost) between the least and most expensive physician (within a specialty and market) to obtain the identical outcome.

In other words, not all doctors perform equally. While more patients are paying out-of-pocket for a larger portion of care, there is still virtually no credible information to guide their physician choices.

The American people could quickly learn which physicians within a specialty and a market consistently get the best outcomes at the lowest costs if Medicare physician data were made publicly available. Releasing these data would also put pressure on physicians everywhere to understand their own numbers, and to improve if their performance values are lacking. We see this as beneficial to the great majority of physicians who seek excellence in their work.

Smoothing the Way
American health care is a vast enterprise in which millions of professionals and hundreds of thousands of organizations vie for an ever larger portion of what has historically been an always growing resource pool. The chaos and dysfunction that has developed in health care is largely due to two system characteristics. One is the fee-for-service reimbursement system that has rewarded more rather than the right care. The other is a lack of transparency that prevents us from knowing and understanding performance, even when that performance is dangerous: what works and what does not, which approaches are high and low value, who does a good job and who does not.

The five action steps outlined above would allow us to better identify the problems and opportunities in our health system, as well as the strongest solutions to drive decision-making. Then they would leverage that information to create strong incentives for the right care, organically changing the dynamics of care and reimbursement and, to the degree possible, smoothing the transition required to heal the way we supply, deliver and finance care in America.

Brian Klepper PhD is a health care market analyst and a Founding Principal of Health 2.0 Advisors, Inc. David C Kibbe MD MBA is a Family Physician and Senior Adviser to the American Academy of Family Physicians who consults on health care professional and consumer technologies

Tuesday, January 6, 2009

Let's Reboot America's HIT Conversation--Part 2: HIT Beyond EHRs

Let's Reboot America's HIT Conversation
Part 2: HIT Beyond EHRs


by DAVID C. KIBBE AND BRIAN KLEPPER

Yesterday we tried to put EHRs into perspective. They're important, and we can't effectively move health care forward without them. But they're one of many very important HIT functions, and EHRs and HIT alone won't fix health care. So developing a comprehensive but effective national HIT plan is a huge undertaking that requires broad, non-ideological thinking.

The danger we face now in developing health care solutions, as we've learned so painfully elsewhere in the economy, is throwing good money after bad. We don't need merely a readjustment of how health IT dollars are spent. We need to reboot the entire conversation about how health IT relates to health, health care, and health care reform in this country. To get there, we need to take a deep breath and start from well-established and agreed-upon principles.

Most of us want a health system that bases care on knowledge of what does and doesn't work - i.e., evidence - whenever possible. We want care that is coordinated, not fragmented, across the continuum of settings, visits and events. And we want care that is personal, affordable and increasingly convenient. Most of us agree that, so far, we have not achieved these ideals. In fact, health care continues to become costlier, quality is spotty, and the gap between the health care we believe possible and the current system is widening.

We believe that most health care professionals are acutely aware that HIT alone cannot resolve these problems. Despite billions of dollars in HIT investments by health care professionals and organizations, the gap persists and is widening. Many physician practices have expanded their HIT functions, moving beyond billing systems - a necessary asset to be paid by Medicare - towards EMRs and from paper to software systems. About a quarter of US physicians use EHRs from commercial vendors. Hospitals and health plans - larger, corporate organizations with more dedicated capital resources - have implemented HIT more quickly. Even so, the tools implemented have typically been focused on recordkeeping and transactional processing, not decision-support. Health care clinical and administrative decisions have not yet become more rational, less tolerant of waste and duplication, or more congruent with evidence. We don't just need more HIT; we need an array of specific functions that can facilitate better care at lower cost in a complex, wasteful system that currently adheres to few evidence-based rules.

What would those better HIT products look like, and what would they do?

Focus on Decision Support
Most important, new HIT would help clinicians, managers, purchasers and patients make the best possible clinical and administrative decisions. This includes identifying risks and following the best path to lowering them whenever possible. In other words, HIT should help people stay healthy and avoid illness through active clinical decision support, and make sure that the system recognizes value. Which patients, according to past data, have chronic or acute conditions that need care? Which, do the data show, are the most effective (or high value) doctor, hospital service, treatment, intervention - so that the market can work to drive efficiency. Given a particular set of signs or symptoms, what is the best next step in care?

Technology and information engineering is readily available to do this. Car technologies now help drivers understand when a problem is occurring, or is likely to occur, monitoring fluid levels, tire pressure, maintenance appointments, and location in case of emergency. Banking technologies can flag suspicious credit card purchases and can instantly invalidate charge cards. Recently, Google trended flu searches to help estimate regional flu activity; their estimates have been consistent with the CDC's weekly provider surveillance network reports.

By comparison, most HIT is relatively unsophisticated. In general, the prevailing frontline tools do not yet help clinicians identify individual- or population-level health risks. They don't yet provide guidance with evidence-based approaches that can best mitigate those risks, or help monitor adherence to care plans, even though the data are now clear that most Americans die and we pay the most money due to easily preventable and managed conditions.

In short, we monitor our cars and bank accounts better than we do our health. We can change this.

Untethering Patients with Easily Accessible Personal Health Information
High value HIT would improve care by making summary personal health information available, increasingly independent of location and time. Most health records are still tied to a health care organization's data center, supporting an outdated business model in which the patient must come to a centralized, expensive location for even the most routine tasks, like history-taking or lab testing. Most current EHRs don't change this, in large part because they aren't connected to the Internet. Web-enabled patient information would untether the patient, and make increasingly standardized care more readily available anywhere. De-coupling health information from health care providers is the first step in the development of new business models that will offer team-based care services wherever one is located, saving money and increasing convenience.

Empowering Patients Through Online Linkages with Clinicians and Other Patients
HIT will link patients with clinicians, will match problems with most appropriate solutions, and will use social networking to increase access to patient- and condition-specific information, knowledge, and guidance. This class of HIT applications will be particularly useful with chronic illness, shifting more of the condition's monitoring and management to the patient and his/her family and peers, with diminished reliance on the office-based physician. Bringing advances like these to fruition will require much broader implementation and access to broadband technologies, as well as standardized health record formats.

Participatory Medicine: Bridging the Medical Home and Web-Based Care
As Kibbe and Kvedar recently wrote, much of the HIT we're describing bridges the divide between two powerful trends: Health 2.0 (or user-generated health care ), and "the medical home." It is now clear that, while most health care consumers want to be more actively engaged in their own care management - e.g., using Web-based search and joining patient communities - they also want to be connected to their physicians for questions and care when appropriate. The way forward here is participatory medicine that combines and remixes health information and knowledge - some from experts and some from the crowd - in the interest of helping us live healthier lives. Here is a very good description from a practicing pediatrician about how this will work:
...organized medicine needs to provide the day-to-day support patients need to prevent disease and to self-manage their conditions if they are ill. In the connected era that means just in time delivery of the personalized and up-to-date data and information a person needs to have the knowledge to make wise choices. It means supporting patients to easily and accurately keep track of their performance. It means providing tailored messages and experience that speak to each person based on their unique characteristics, their performance on key behaviors and their needs at that moment in time. It means helping patients link directly to family and friends for critical support, and link to their many providers to help integrate medical care with everyday life.
Data and Accountability
HIT can help make all health care professionals and organizations - physicians, hospitals, other providers, health plans, drug firms, device firms - more accountable for quality, safety, and cost results, and for the engineering required for continuous improvement. We can learn from our current supply, care delivery and finance processes in the same ways that Toyota and Wal-Mart monitor their internal business processes. The problem is not just that we lack some important data elements to carry out these analyses now. More to the point, we have not committed nationally to aggregating, analyzing, and reporting the massive amounts of health data that we already have. Similarly, due to a lack of incentives and competing interests, most professional and organizational health care players have resisted using data to improve the quality, safety and cost of American care.

Closing the Collaboration Gap
Finally, a new generation of HIT capabilities will close the "collaboration gap" that exists between the system's many sequestered players, who as a result perform so much less effectively and efficiently than they otherwise might. Clinicians, for example, diagnose disease and set up treatment plans but often are isolated from helping their patients cope, manage, or adhere to these plans. Patients, once diagnosed, are motivated to manage their illnesses but often have few tools or methods to assist them. Purchasers and payers want to see clinicians use the most efficacious resources, but typically do not have a way to inform and reward evidence-based purchasing processes. In every case, HIT can facilitate a more collaborative experience that is tailored to the user's purpose, no matter what role that user plays in vast health care space.

HIT presents enormous, unprecedented opportunities to improve the quality of care, to dramatically reduce the waste and cost inherent in our current approach, and to culturally transform patients to become more actively engaged in their own health and care. Bringing the fluidity of knowledge and data to fruition will allow us to leverage the true power of information, and that can take many forms. The real HIT challenge to the Obama health care team is to step back, take stock of the kinds of applications that are emerging in HIT, and create an expansive, open policy structure that can leap beyond the status quo and really change the way American health care, in all its facets, works.

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. Brian Klepper PhD is a health care market analyst and a Founding Principal of Health 2.0 Advisors, Inc.

Monday, January 5, 2009

"Let's Reboot America's HIT Conversation---Part 1: Putting EHRs in Context"

Last Month David Kibbe and Brian Klepper asked me to post an open letter to the Obama Health Team with their thoughts on how to spend the coming federal health IT money. That letter ended up as the centerpiece of a Boston Globe story with the lead line, "some specialists are warning against investing too heavily in existing electronic recordkeeping systems."

Encouraged by the response to that letter, they have asked me to post their follow-up in two parts. The first part is below and the second part will be posted tomorrow.

Let's Reboot America's HIT Conversation
Part 1: Putting EHRs in Context


by DAVID C. KIBBE AND BRIAN KLEPPER


On December 19th, we published an Open Letter to the Obama Health Team, cautioning the incoming Administration against limiting its Health Information Technology (HIT) investments to Electronic Health Records (EHRs). Instead, we recommended that the HIT plan be rethought to favor a large array of innovative applications that can be easily adopted to result in more effective, less expensive care.

The response to that post was vigorous - we received many comments and inquiries from the health care vendor, professional and policy communities - urging us to provide more clarity. One prominent commentator called to ask whether we, in fact, supported the use of EHRs. We both have been active EMR and HIT supporters for many years. Dr. Kibbe was a developer of the Continuity of Care Record standard, a de facto standard format for Electronic Medical Records (EMRs), and has assisted hundreds of medical practices to adopt EHRs. Dr. Klepper has been involved in EMR projects for the last 15 years, and the onsite clinic firm he works with provides every clinician with a range of HIT tools, including EMRs.

That said, we are realistic about the problems that exist with health information technologies as they are currently constituted. As we described in our previous post (and contrary to some recent claims), most products are NOT interoperable, meaning licensees of different commercial systems - each using different proprietary formats - often find it difficult to exchange even basic health care information.

Most EHRs are bloated with functions that often are turned off by practitioners, that are promoted politically through the current CCHIT certification process, and that drive up costs of purchase, implementation and maintenance. Despite moving toward Web-based delivery models that have MUCH lower transactional costs than old-fashioned client/server approaches, most commercial offerings are still extremely expensive, especially compared to the revenue flows of the relatively small operations they support. (John Halamka MD's recent recommendation that the Fed invest $50,000 per clinician for rapid implementation of "interoperable CCHIT certified electronic records with built in decision support, clinical data exchange, and quality reporting" provides an idea of the resource allocations that are on the table.) The very wide range of choices in the market currently raises the question of whether the implementation of a national EHR infrastructure MUST be so costly.

Many health care professionals still think of HIT as a compartmentalized function within health care organizations. But HIT has increasingly become the glue between and across all health care supply chain, care delivery and financing enterprises. In the past, it was enough for HIT to facilitate information exchange inside organizations - in which case a proprietary system would do - but we now expect information to be sent and received seamlessly, independent of platform, and including over the Internet. Most of the currently dominant EHR technologies don't even begin to get us there.

Nor, despite the rampant optimism about its potential, can a focus on HIT alone - or even more emphatically, EHRs - resolve health care's deeper problems. As the noted health care economist Alain Enthoven wrote in a December 28 New York Times editorial:
[President-elect Obama]... has suggested, for example, that electronic medical records could save Americans nearly $80 billion per year. But information technology cannot bring meaningful savings if it is used in a health care system that regularly rewards waste and punishes efficiency, as ours does.
In other words, as the recent reports from the Congressional Budget Office and the Dartmouth Atlas point out (yet again), real reforms will require an array of significant changes, many of which will face withering opposition from entrenched interests. One of those interests is the established health care information technology sector, which stands to finally win handsomely from huge Federal investment in their current products.

The good news is that this is the position held by Peter Orszag, the incoming Director of the Office of Management and Budget, the current Director of the Congressional Budget Office, an astute student of health care dynamics, and a key member of the Obama health team. In testimony before the Senate Finance Committee, July 18, 2008, he said:
The bottom line is that research does indicate that, in certain settings, health IT appears to facilitate reductions in health spending if other steps in the broader healthcare system are also taken to alter incentives to promote savings. By itself, however, the adoption of more health IT is generally not sufficient to produce significant cost savings.
In other words, it is fair to be skeptical about how we should proceed with a national HIT build-out effort. The HIT industry's current product/service offerings are analogous to the auto industry's obsession with SUVs, as much the problem as the solution. Just as the auto industry can be re-purposed to build lower-energy, less wasteful vehicles, so too should the HIT industry be encouraged to offer smarter products that serve the interests of an affordable, convenient, and evidence-based health care system.

A smorgasbord of Health Information Technologies is available to help us build a far better health system. Part 2 will describe some functions that a national HIT infrastructure renewal effort might consider.

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 and a Founding Principal of Health 2.0 Advisors, Inc.

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