Monday, August 31, 2009

Advice For State REC Planners


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

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

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

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

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

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

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

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

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

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

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

    Similarly, some practices will prefer to locate data servers inside their practices or at the community hospital. Others will opt for Clinical Groupware, web-based and remote services EHR technologies that offer less hassle and expense for maintenance and security. Recognizing and differentiating between EHR technology offerings is going to be a major challenge for REC personnel in the near future.
  1. Skate to where the puck will be. The old paradigm of health data management tried to collect a patient's complete data in a single database application, owned, maintained and controlled by a particular organization. However, throughout other disciplines, information management has become Web-centric and based on meta-data searches augmented by real-time communications and shared group activities. Think Wikipedia, Google docs, Microsoft Sharepoint, the Apple iPhone, and, yes, even Facebook, as representative of where health IT is migrating over the next few years.

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

    We hope that ONC's specifications, issued as guidance to the RECs by mid-2010, reflect market-driven innovations that can reduce the cost and complexity of EHR technology acquisition and use. Otherwise we're in for a national exercise in chaos.
  1. Don't waste time re-inventing the wheel. Every REC should network with every other REC, regardless of location or stage of development, to share lessons and experience, and to avoid wasted effort. In the past, for example, regional helper organizations - some QIOs and medical societies - independently formed exclusive contracts with one or two EHRs vendors, hoping these arrangements would simplify choices and implementation. These proprietary relationships were invariably unsuccessful for the helper organization and for the practices.

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

    RECs should collaborate on tools and instruction kits where ever possible: each REC doesn't need to develop its own HIPAA privacy and security guide book, for instance. Remember that peripheral devices, such as printers, fax machines, and modems, are part of every office's set up, and that these items can be troublesome to set up and use.
  1. Come to the task understanding that successful HIT implementation requires fundamental process re-design. We've learned this the hard way. Unless health IT helps re-design practice work and information flow processes so they can be more efficient and quality-promoting, then the IT is simply an expensive appliance. Process re-design also can determine whether the EHR technology deployment produces a return on investment (ROI). For example, re-designing the documentation process to reduce or eliminate dictation transcription services, relying instead on EHR data entry by office staff and the physicians themselves, can save money and lead to an ROI within 12-24 months. We have seen this occur frequently. On the other hand, practices that continue dictation at the old levels are simply adding new data capture expense, making it harder to justify the investment.

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

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

Thursday, August 27, 2009

Health Care Reform's Deeper Problems

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

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

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

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

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

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

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

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

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

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

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

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

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

Thursday, August 13, 2009

A Letter To The National Coordinator for Health IT

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

August 10, 2009

Dear Dr. Blumenthal:

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

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

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

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

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

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

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

Thank you for your consideration.


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


Steve Adams, CEO, RMDNetworks, Inc.

Richard Benoit, Dossia

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

Warren Brennan, CEO, SMA Informatics, Richmond

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

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

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

Sarah Greene, Managing Editor, Journal of Participatory Medicine

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

Adrian Gropper MD, Chief Science Officer, MedCommons

James Allen Heywood, Chairman and Co-Founder, PatientsLikeMe

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

Vince Kuraitis, Prinicpal, Better Health Technologies, LLC

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

Randall Oates, MD, President, SOAPware, Inc.

Martin Pellinat, CEO, VisionTree Software, Inc.

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

Jane Sarasohn-Kahn, Principal, Think Health, Philadelphia

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

Ravi Sharma, CEO, 4Medica

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

Carl Taylor, Director, Center for Strategic Health Innovation

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

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

Tuesday, August 4, 2009

Finally, A Reasonable Plan for Certification of EHR Technologies


A caution to readers: This post is about methods for certifying Electronic Health Record (EHR) technologies used by physicians, medical practices, and hospitals who hope to qualify for federal incentive payments under the so-called HITECH portion of the American Recovery and Reinvestment Act (ARRA). It may not be as critical as the larger health care reform effort or as entertaining as Sarah Palin, but it WILL matter to hundreds of thousands of physicians, influencing how difficult or easily those in small and medium size practices acquire health IT. And indirectly for the foreseeable future, it could affect millions of American patients, their ability to securely access their medical records, and the safety, quality, and the cost of medical care.

Three weeks ago, on July 14-15, 2009, the ONC's Health IT Policy Committee held hearings in DC to review and consider changes to CCHIT's current certification process. The Policy Committee is one of two panels formed to advise the new National Coordinator for Health IT, David Blumenthal. In a session that was a model of open-mindedness and balance, the Committee heard from all perspectives: vendors, standards organizations, physician groups, and many others.

And then, on July 16, they released their final recommendations on what is now referred to as "HHS Certification." The effects of their recommendations - these are available online and should be read in their entirety to grasp their extent - are potentially monumental, and could very positively change health IT for the foreseeable future.

At the heart of these hearings was the issue of who will define the certification criteria and who will evaluate vendors' products. Among many others, we have voiced concerns that the Certification Commission for Health Information Technology (CCHIT), the body currently contracted by HHS to perform EHR certification, has been partial to traditional health IT vendors in defining the certification criteria, and in the ways certification is carried out, and thereby able to inhibit innovation in this industry sector. Despite its leaders' claims that the certification process has been developed using an open framework, CCHT's obvious ties to the old guard IT vendors have created an overwhelming appearance of conflict of interest. That appearance has not been refuted by CCHIT's resistance to and delays in implementing interoperability standards, or by its focus on features and functions over safety, security, and standards compliance.

In the hearings that led to the recommendations, longtime IT watchers were treated to some extraordinary commentary, much of which dramatically undermined CCHIT's position.

"HHS Certification means that a system is able to achieve government requirements for security, privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects...HHS Certification is not intended to be viewed as a 'seal of approval' or an indication of the benefits of one system over another."

In other words, as the definition of Meaningful Use is now tied to specific quality and safety improvements and cost savings that result from health IT -- among them e-Prescribing, quality and cost reporting, data exchange for care coordination, and patient access to summary health data -- HHS Certification will closely follow. Rather than pertain to an EHR's long list of features and functions, some of which have nothing to do with Meaningful Use, certification will be focused on each IT system's ability to enable practices and hospitals to collect, store, and exchange health data securely.

Who Determines the Certification Criteria

The Office of the National Coordinator - not CCHIT - would determine certification criteria, which "should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives." As regulator, funder for this project, and a major purchaser of health services, the government, not users or vendors, will now determine HHS' Certification criteria.

A New Emphasis on Interoperability

"Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit." That is, functions/features criteria will be broadly defined, but there will be a greater focus in the future on the specifics associated with bringing about straightforward data exchange.

Multiple Certifying Organizations

ONC would develop an accreditation process and select an organization to accredit certifying organizations, then allow multiple organizations to perform certification testing. In other words, the Committee recommended that CCHIT's monopoly end.

Third Party Validation

The "Validation" process would be redefined to prove that an EHR technology properly implemented and used by physician or hospital can perform the requirements of Meaningful Use. Self-attestation, along with reporting and audits performed by a Third Party, could be used to monitor the validation program.

Broader Interpretation of HHS Certification

HHS Certification would be broadly interpreted to include open source, modular, and non-vendor EHR and PHR technologies and their components.

These bold, forward-thinking proposals from the HIT Policy Committee have not been accepted yet. But in our opinion they should be. These measures would encourage new technologies to enter the market for physician medical practices seeking EHR technology, and wrest control away from the legacy health IT vendors that have maintained barriers and delayed adoption, so you can be sure that the old guard players are doing everything possible to have them rejected.

But these are hugely progressive steps in the right direction, toward allowing HIT to enable improvements in care and cost efficiencies that would be in the best interests of users and the public at large. If implemented, the changes recommended by the HIT Policy Committee would create greater choice, more standardization, lower price, less interruption of the practices -- as well as a check from CMS or Medicaid each year to help smooth the implementation, starting in 2011.