Wednesday, April 29, 2009

Meaningful Use

Big news!!! Yesterday the chairman of the Certification Commission for Healthcare Information Technology (CCHIT) provided insight into the methods that may be used to prove "meaningful use" of an eHR. Dr. Mark Leavitt testified at the National Committee for Vital and Health Statistics (NCVHS) Executive Subcommittee hearings on the topic of “EHR Product Certification” and “meaningful use” as they apply to the American Recovery and Reinvestment Act (ARRA).

The full transcript from that presentation appears below.
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Certification and Meaningful Use
Testimony before the
National Committee on Vital and Health Statistics
Executive Subcommittee
Hearing on "Meaningful Use"
Panel 9: EHR Product Certification
Mark Leavitt, MD, PhD
Chair, Certification Commission for
Healthcare Information Technology (CCHIT)
April 29, 2009
Chairman Reynolds, members of the Committee, thank you for this opportunity to testify on the relationship between certification and meaningful use of electronic health records (EHRs). I am Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology (CCHIT), a nonprofit, 501(c)3 organization. Over the past 3½ years, we have worked under a contract from ONC to develop and validate certification criteria and inspection processes for EHRs and other forms of health IT, and we have been the Federally recognized certifying body since 2006. Because of today’s time limits, I will focus on answering the questions you posed, but you will find additional details in an Appendix at the end of the slide presentation.
What role does certification play in promoting meaningful use?
The usual role of certification is to reduce risk. Whether it’s toasters, cars, or airplanes, risks are mitigated by setting standards and inspecting products to ensure compliance. Certifying bodies may be in the private sector or a government function, and there are various funding models. In any case, certification is most valuable when risks are high, or when product quality and suitability are difficult for the technology consumer to evaluate – factors that apply to health IT.
During our initial years, certification served as a confidence-booster for providers concerned about buying EHRs that lacked the needed functionality, security, and interoperability. Financial incentives for EHRs then began to emerge, but they pale in comparison to the bold goals and nationwide scale of the Recovery Act.
Now, as health leaders, we must make progress on three tightly interdependent paths at the same time. Promoting EHR adoption and use is just one track. The second is to develop and sustain health information exchange. Finally, we must reform – and ultimately transform -- the health system. Because the journey is long and complex, we will need to assess and reward progress at incremental steps along the way. Certification must step up to fulfill a more strategic role, serving not only to reduce risks, but as a dynamic coupling mechanism between advancing policies and the real-world development, marketing, adoption, and use of health IT.
What are the strengths and weaknesses of current CCHIT processes, and how should they change to meet the requirements of the Recovery Act?
Since its founding, the Commission has recognized that its critical success factor -- and principal asset – would be credibility so our processes were designed accordingly. Certification criteria development is highly transparent, involves diverse volunteer contributions, and includes multiple cycles of public comment as well as a pilot test. Inspections are robust and repeatable, and the staff and volunteers conducting them may not have any financial relationship with vendors.
The evidence shows broad acceptance of certification. We have strong industry engagement and support, with more than 640 volunteers seeking to join us this year. The largest physician professional organizations have endorsed the Commission’s work. Once the success of certification programs for EHRs in ambulatory care and hospitals was demonstrated, providers in other domains urged us to expand, and we added programs for the Emergency Department, Child Health, and Cardiovascular EHRs last year. This summer we will launch standalone ePrescribing and PHR certification, with eight more programs, including Long Term Care, to be developed for 2010. There has been rapid uptake by vendors in every domain. Finally, certification has earned the confidence of payers. Incentives for CCHIT Certified EHR adoption include the Medicare EHR Demo, the Stark law safe harbor, several State EHR initiatives, pay-for-performance programs such as Bridges to Excellence, and even physician liability insurance discounts.

All of these accomplishments are a credit to the contributions of our volunteers. But we must also listen to our critics, and strive to improve our processes. One weakness we are keenly aware of – illustrated by Dr. Classen yesterday – is that purchasing a certified EHR does not guarantee successful implementation. While we can’t promise to eliminate this risk completely, the Commission, at its last meeting, approved investigation into how we might measure and rate factors beyond the product, including usability, training, implementation, and success rates.
We are also aware that our certification policies are not sufficiently compatible with open source licensing models. We have opened a dialog with that community, hope to find constructive solutions, and will update our policies this summer. We also want to ensure that certification fees do not pose a barrier to nonprofit developers whose EHR designs serve vulnerable populations; we are seeking grant funding to partially defray those costs for them. Finally, although a diversity of vendors, small and large, have attained certification, we don’t want to obstruct the next Thomas Edison of health IT from realizing an innovative breakthrough. We are thinking about offering cost-effective ‘experimental’ certifications for self-developed or self-assembled EHRs that are not for commercial resale.
Summing up our answer to your question, we recognize the higher expectations placed upon certification by the Recovery Act, and we will rise to meet them. We intend to step up our accountability and transparency, broaden the scope of our measurements, continue expanding to new domains of care, and respond to the new pace of progress.
How should the certification process work in 2011, and how should it develop over time in support of increasingly robust requirements for meaningful use in 2016 and later?
Defining how meaningful use will be measured is now an urgent priority for ONC. Speaking for the moment as an EHR veteran, rather than as Commission chair, here are my thoughts. First, documentation of meaningful use should be fully electronic, not manual. Second, today’s certified EHRs are inherently capable of collecting ‘meaningful use’ measures as part of normal operation. It should be possible to require certified EHRs to do the following: a) register their existence and usage by eligible providers, b) generate and display a ‘meaningful use’ dashboard, c) electronically sign and submit dashboard statistics to a designated entity, and d) retain audit trails for future verification. Certification will play an important role in combating the possibility of fraud in all of these steps.
A standardized ‘meaningful use’ dashboard and report submission tool should be developed as a community open source project, and its measure calculations should be fully transparent. The measures would be tailored to different practice domains, and the benchmarks for incentive payments would be raised every two years. The dashboard should be viewable daily by providers. EHR vendors would only need to connect this public domain tool to their EHR databases databases to comply. I believe this will be the first realization of Dr. Clancy’s ‘press F7 for quality measures’ vision, and I was excited that Dr. Cullen of the Indian Health Service shared creative ideas along these same lines yesterday.
We agree with the recommendation by HIMSS that requirements should step up on a two-year cycle, and we will adapt our certification work to match. Naturally requirements must be published in advance, and time allowed to validate certification testing and to get products certified to fulfill the needs of providers.
Chairman Reynolds, committee members, and Dr. Blumenthal, thank you again for your leadership, and I look forward to taking your questions.

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