Statement by
Simon Cohn, M.D., M.P.H.
National Committee on Vital and Health Statistics
Department of Health and Human Services

HHS Implementation of Project BioShield

Subcommittee n Health
Committee on Energy and Commerce
US House of Representatives

Thursday, April 6, 2006

Good afternoon, Madame Chairman and distinguished Members of the Subcommittee. I am Dr. Simon Cohn, Chairman of the National Committee on Vital and Health Statistics (NCVHS). The Committee is the statutory federal advisory committee to the Secretary of Health and Human Services on health data, statistics and health information policy, including data standards and privacy issues. I am also the Associate Executive Director of the Permanente Federation, Kaiser Permanente. Kaiser Permanente is the nation’s largest integrated nonprofit, health care organization, serving the needs of 8.4 million members in nine states and Washington, D.C. The Permanente Federation is the national organization of the Permanente Medical Groups, the physician component of Kaiser Permanente.

I am testifying today in my capacity as NCVHS Chairman. All of the information I will be discussing today is available on the NCVHS website at ncvhs.hhs.gov.

This afternoon, I will focus my remarks on (1) the role, history and perspective of the Committee; (2) our experience and perspectives relating to the adoption of national health data standards; (3) reflections on how the standards adoption process might be improved and accelerated; and (4) our perspectives on how the various current national health IT and data standards initiatives can work together to advance the national HIT agenda.

Role, History and Accomplishments of the NCVHS
The NCVHS has a long and distinguished history of facilitating the development of industry and government consensus on health data policy issues and data standards and providing broad based expertise and advice to the HHS and other federal health agencies. The NCVHS is established by law in section 306(k) of the Public Health Service Act and has a mandate to assist and advise the Secretary on a wide array of health care data issues. In recent years, Congress has directed the Committee to play a role in consensus development and an advisory role in data standards, initially through the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and subsequently in the Medicare Modernization Act of 2003 (MMA). The Committee’s HIPAA responsibilities included advising the Secretary on data exchange standards, code set and terminology standards, privacy and security standards, and identifiers, and in MMA, on the data standards needed to support the electronic prescribing provisions of MMA. The Committee is recognized and highly regarded for its open, well established, collaborative industry public-private consultation process and its timely, thoughtful and practical recommendations.

Members of the Committee are appointed from among individuals distinguished in a wide range of health information policy areas, including health statistics, electronic interchange of health care information, privacy, security, population-based public health, purchasing or financing health care services, integrated computerized health information systems, health research, consumer health advocacy, health data standards, epidemiology, and the provision of health services. Sixteen members are appointed by the HHS Secretary, and two are appointed by the leadership of the Senate and the House of Representatives respectively. Technical experts and representatives of all stakeholders - including providers, plans, commercial interests, not-for-profit groups, governments, and consumers- provide input to NCVHS deliberations through regular, extensive public meetings.

Through its advice and recommendations, NCVHS has stimulated a host of improvements in national and international health information infrastructure, data and statistics. The Committee has been associated with contributions in disease classification, health surveys, data standards, data needs for minority and other special populations, mental health statistics, State and community health data needs, and privacy protection. While the NCVHS may be best known for its work on data standards and health information exchange, it has played a significant role in public and population focused health data issues and needs as well.

Recent accomplishments related to the topic under discussion today include:

Strategic Vision for Health Information Infrastructure — The NCVHS’ 2001 report, Information for Health: A Strategy for Building the National Health Information Infrastructure, set forth a vision and framework for interoperable health information technology (HIT). The report identified three primary dimensions that together comprise a national health information infrastructure - information to support the needs of 1) patient care, 2) population and public health, and 3) personal health. The report recommended and foreshadowed many of the accomplishments and initiatives we see underway today, including the creation of an office to provide leadership and coordination for the development of the National Health Information Infrastructure (NHII), reporting directly to the Secretary, an idea later reflected in the President’s Executive Order and the HHS initiative to establish the Office of the National Coordinator for Health Information Technology in HHS.

Strategy for Healthcare Information Interoperability — In 2000, the NCVHS published a report, Uniform Data Standards for Patient Medical Records Information, that set forth a strategy, framework, and criteria for selection of clinical data standards. This strategy provided the foundation for the selection of clinical message format standards (2002) and clinical terminology standards (2003) that have become the core of the Consolidated Health Informatics Initiative.

Electronic Prescribing — The Medicare Modernization Act directed NCVHS to identify and recommend standards for e-prescribing that could be used in implementing the new Medicare Part D benefit. NCVHS accelerated its schedule of meetings and proposed an initial set of well-established standards that were later incorporated into a proposed rule. This allowed the industry to fill standards gaps and harmonize related standards in time for e-prescribing pilot tests beginning in January 2006. The process also served as a model for obtaining industry input into the regulatory process.

Personal Health Records - Last September the NCVHS issued a report of findings and recommendations concerning electronic personal health records and personal health record systems. Based on six public meetings, the report describes the current heterogeneity and state of the art in PHR concepts and systems, discusses the potential roles that PHR systems could play in improving health and health care and furthering the broader HIT agenda, and sets forth 20 recommendations for moving forward.

Population Health — Recommendations in the Committee’s report, Shaping a Health Statistics Vision for the 21st Century, described a model of the influences on the population’s health and established guiding principles to improve integration and coordination of health data and information used by policymakers, researchers, and the public to improve health.

Eliminating Health Disparities: Strengthening Data on Race and Ethnicity - Released last November, this NCVHS report identified a number of opportunities and recommendations for improving data on race and ethnicity to help understand, measure and eliminate disparities in health and health care.

HIPAA Administrative Simplification Data Standards - In HIPAA, Congress directed the Committee to assist and advise HHS in the adoption of a range of industry consensus data standards to support administrative simplification in health care. The standards included data transaction standards, code sets and terminology standards, privacy and security standards and identifiers. For the last decade, NCVHS recommendations formed much of the basis for the subsequent HHS regulations adopting the standards for use in administrative transactions in health care. NCVHS also advises HHS on HIPAA implementation progress and prepares an annual report to Congress on the progress of the HIPAA data standards initiative.

Improving and Streamlining the Standards Adoption Process: Lessons Learned
Based on NCVHS experience in working with the industry and assisting and advising on the adoption of various types of data standards, several "lessons learned" have emerged for improving the overall process.

HIPAA Administrative Simplification Standards
NCVHS has advisory responsibilities for assessing the impact of the adoption and use of transactions and code sets that are ultimately adopted under the administrative simplification provisions of the HIPAA. The process starts when the various standards development organizations (SDOs) work with their membership to reach consensus on HIPAA transactions and code sets that need to be adopted or modified and those changes are brought to NCVHS for review. The Committee generally explores these recommendations through its established open meeting process. The NCVHS process ends with a recommendation letter to the Secretary of Health and Human Services based on the testimony that was provided. Further Department evaluation, based on the recommendations, usually results in the start of the required rule making process.

With regard to HIPAA data standards, there are several lessons that the Committee gleaned through the numerous meetings that have taken place since this landmark legislation was passed a decade ago. HIPAA implementation has taken longer than expected. Our explanation for this includes the complexity and diversity of administrative processes in healthcare, the number of players involved, and the complexity of the federal rulemaking process.

NCVHS testimony noted that inability to effect timely and orderly introduction, adoption and updating of HIPAA standards severely hampers the ability of the public and private sectors to keep pace with emerging needs, especially in the rapid acceleration toward the adoption of EHRs. The unpredictability of the time needed to complete all of the steps in the federal rule making process create an uncertain environment in which it is difficult for providers, payers and vendors to influence or anticipate upcoming changes and develop business products and processes to accommodate them. The inability in a timely fashion to adopt new versions of standards under HIPAA coupled with the uncertainty of the timing of changes prevents the HIPAA community from evolving to new standards that address current business needs. The NCVHS continues to believe that the full economic benefits of Administrative Simplification will only be realized when all the standards are in place and when an orderly change management process has been successfully established.

Electronic Prescribing Data Standards
NCVHS’ role and experience in recommending e-prescribing standards was entirely different from that in the HIPAA process. The MMA specified that NCVHS should develop recommendations on standards used for e-prescribing under the new Medicare Part D drug benefit. It included a fairly long list of needed standards functionality for e-prescribing. The MMA additionally specified that some of these standards could be adopted immediately after rulemaking without pilot testing if they had adequate industry experience while the remaining standards would need to be pilot tested during calendar year 2006 and subject to subsequent rulemaking.

Based on the specificity and rigorous time frames of the MMA, NCVHS had 18 months to complete its work on this emerging topic. The Committee held several meetings to understand the current e-prescribing process and identify the relevant stakeholders in order to ensure balanced testimony. NCVHS then proceeded with meetings on the existing e-prescribing environment, and identified gaps in terms of the specific standards required by the MMA and specific supporting standards needed by the industry.

The process concluded with two comprehensive recommendation letters developed in partnership with various industry groups that were sent to the HHS Secretary. NCVHS’ recommendations on e-prescribing standards that could be adopted without pilot testing were adopted in a final rule in November 2005 that laid out "foundation standards" for use in Part D. NCVHS’ other recommendations on standards that needed to be pilot tested were incorporated into the required pilot tests that began on January 1, 2006, as specified by the MMA.

Testimony from the industry highlighted a critical need for a flexible and timely standards modification process. Because the MMA has different requirements from HIPAA, some latitude was possible for adoption of new standards. The NCVHS recommendations suggested the concept of voluntary adoption of new standards if they maintain the base functionality and data content of previous versions ( backward compatibility). This was incorporated into final rulemaking.

Moving Forward and Lessons Learned
The NCVHS’ open, collaborative process has repeatedly proven its effectiveness. NCVHS has served as an honest broker for a wide range of issues and stakeholders. This process has been used to provide advice and guidance on the HIPAA standards. The value of this process was especially apparent for recommendations for e-prescribing standards under the MMA, when the NCVHS identified the relevant stakeholders, brought them to the table, and broke new ground in terms of identifying standards, gaps, and workable solutions. This additionally was accomplished within the confines of tight timeframes and content requirements imposed by the statute. Because of the way NCVHS structured its process, the industry voluntarily coalesced to develop solutions that would benefit all stakeholders.

Pilot testing plays an essential role in "road-testing" new standards. Even small pilots yield valuable information that can help speed implementation.

Establishing standards for transactions does not automatically lead to complete standardization of business practices. There will always be variation, but industry efforts to reduce unnecessary variability in business rules should be encouraged.

There is a critical need for a standards change management process that can nimbly keep up with changes in business needs. One possibility might be to widely implement a process analogous to the e-prescribing voluntary adoption process, where the adoption of new versions of standards are allowed as long as they are backward compatible, for other standards, including HIPAA. However, since not all SDO standards are backwards compatible, this would not represent a total solution. Another option could be to streamline the adoption of version changes to already adopted standards by asking NCVHS to hold open meetings on such changes, and if broadly accepted by the healthcare industry, recommend that HHS utilize a modified rulemaking process in these circumstances.

Moving Forward on Data Standards and Interoperable Health Information Technology
The Committee is very pleased and supportive of the current interest and initiatives at the national level to promote and accelerate the adoption of interoperable health information technology to improve health and is both eager and committed to helping to move progress forward. In many instances, the initiatives reflect concepts and recommendations and approaches that arise directly from the productive and collaborative relationship involving the NCVHS, HHS and the industry.

To this end, I met with Secretary Leavitt last June to discuss the role that the National Committee on Vital and Health Statistics could play in supporting this agenda for improving health and health care through advances in interoperable health information technology, and I was gratified with his enthusiastic response when I offered our expertise, advice and service in support of his HIT agenda. During the inaugural meeting of the American Health Information Community, Secretary Leavitt indicated that he would be relying on the NCVHS for expertise and advice on advancing the national Health Information Technology agenda, particularly on privacy and information infrastructure issues.

I have also met with David Brailer and have indicated that the Committee stands ready to assist and advise HHS in a number of ways, including coordinating with and complementing the American Health Information Community for achieving objectives of nationwide electronic records that will result in improved health. The AHIC is currently focusing its efforts on achieving rapid breakthroughs in specific areas and achieving industry executive level interest and buy-in.

In addition, to further enhance coordination, we include briefings and updates from Dr. Brailer at all of our full committee meetings,and NCVHS members are included as technical experts on several of the AHIC breakthrough Working Groups. We are continuing to work with Dr. Brailer’s office to explore additional areas for collaboration.

As I indicated to you earlier, the Committee welcomes the new roles that are possible for NCVHS with respect to working with the AHIC and the national health infrastructure agenda generally.

Thank you for the opportunity to testify today about the Committee’s activities relating to health information technology. I would be pleased to respond to any questions that you or other Members might have.

Last Revised: April 7, 2006