American Health Information Community

Biosurveillance Workgroup

Summary of the 13th Web Conference of this Workgroup

Friday, January 5, 2007

PURPOSE OF MEETING

• Review and approve proposed new name for the Biosurveillance (BSV) Workgroup (WG).

• Hear presentation on the State Alliance for e-Health.

• Review and approve proposed “Broad Charge for the Expanded Scope” of BSV WG.

• Review and discuss background document for proposed Broad Charge (“Background Document for Expanded Scope: Population Health and Clinical Care”).

• Discuss testimony needed for BSV WG biosurveillance priority areas of Adverse Events Reporting and Response Management for BSV WG February and March 2007 meetings.

• Review changes to the timeline for the BSV WG Letter of Recommendation to the American Health Information Community (AHIC).

K EY TOPICS

1 . Presentation on the State Alliance for e-Health

The State Alliance for e-Health (State Alliance) is a State-led effort to develop real-world solutions and model practices for addressing State-level barriers to widespread adoption of health information technology (HIT) and challenges to interoperable health information exchange (HIE).

Kathleen Nolan, Director, Health Division, National Governors Association’s (NGA) Center for Best Practices, gave a slide presentation on the State Alliance, beginning with an overview:

• The State Alliance has a sole source contract through the Office of the National Coordinator for Health Information Technology (ONC) for September 2006 through September 2007, with two additional option years.

• The State Alliance is working with a number of partner organizations such as the National Conference of State Legislatures, the National Association of Attorneys General, the National Association of Insurance Commissioners, the National Conference of Commissioners on Uniform State Laws, the Association of State and Territorial Health Officials (ASTHO), the National Association of State Medicaid Directors, and others.

The structure of the State Alliance consists of 12 voting members (2 current Governors, 2 former Governors, 4 State legislators, 2 State Attorneys General, and 2 State Insurance Commissioners), supported by an Advisory Committee of 8 nonvoting members and also by 3 Task Forces, on Health Information Protection, Health Care Practice, and Health Information Communication and Data Exchange. The goal is to have the broadest perspective possible from as many States as possible and expertise available from different sectors, including State leaders on health issues, health information technology, and public health as well as, potentially, private-sector representatives.

Two Co-chairs have been appointed for the first year in advance of the first State Alliance meeting January 26, 2007: Governor Phil Bredesen of Tennessee and Governor Jim Douglas of Vermont. Other members are still being appointed.

Goals for the State Alliance are as follows:

• From a State-specific perspective, address barriers to HIE and adoption of HIT while preserving privacy, security, and consumer protections.

• Build consensus in seeking harmonization of the variations in State policies, regulations, and laws, where appropriate, and develop standards and/or guidance for modifying such policies, regulations, or laws.

• Allow for dialogue among States that will fuel creativity and partnerships among States and with the private sector in the HIT arena.

• Allow for the appropriate input of experts and others working on HIT endeavors to inform State policymaking.

Early issues to be addressed by the Task Forces are as follows:

• The Health Information Protection Task Force will address privacy and security issues, receiving input from the NGA’s Privacy and Security Contract and any follow-up work in States.

• The Health Care Practice Task Force will address State licensure laws that hinder [or support] the ability to engage in HIE and telemedicine, as well as medical malpractice and medical record and liability issues.

• The Health Information Communication and Data Exchange Task Force will analyze appropriate States role in models for HIE; explore means to integrate State-level HIE with public health programs, including Medicaid; and identify public funding opportunities and priorities.

• Other Task Forces may be added as necessary.

The State Alliance is recruiting members for the Task Forces. Specifically, the following of are of interest, in terms of their roles in or relationship to States:

• For the Health Information Protection Task Force:

  • State Health Information, Security and Privacy Collaboration project members

  • Industry privacy and security experts

  • Consumers

  • Mental health and/or genetics directors

  • State public health officials

  • Health plan representatives

  • Hospital representatives and physicians

  • Clinical researchers

• For the Health Care Practice Task Force:

  • Medicaid directors and/or regulatory agency leaders

  • State medical and allied health professionals board representatives

  • State boards of pharmacy representatives

  • Pharmacy Benefit Managers and/or chain pharmacy representatives

  • Lab representatives

  • Quality measurement organization representatives

  • Technical experts

• For the Health Information Communication and Data Exchange Task Force:

  • Employers (within the State)

  • Medicaid program representatives

  • Existing information organization representatives

  • State health plan representatives

  • Physicians

  • Hospital representatives

  • A pay-for-performance expert

  • Lab representatives

  • Chain pharmacy representatives or Pharmacy Benefit Managers.

State Alliance meeting schedules and public access are as follows:

• After the first meeting of the Alliance on January 26, 2007, the Alliance will meet quarterly.

• Task Forces will each meet monthly.

• All in-person meetings will be open to the public.

• Alliance meetings will be Webcast and Task Force meetings transcribed.

• An Alliance Webpage will exist on NGA’s Website to provide transparency and a means of tracking issues.

• Other outreach and input opportunities will be developed, particularly to keep States informed and to solicit their views/perspectives.

Outcomes and products will be determined by the Alliance and may include:

• Model laws and regulations on key issues

• Guidance and measures for collaborative cross-sector efforts

• Recommendations on key State actions by legislative and/or executive leadership.

Outcomes are expected to be complementary and supportive of ongoing efforts, including in the policy arena. The State Alliance actively will seek input and wisdom from other efforts, including those of AHIC and its WGs. Dr. Nolan commented that many State leaders are interested in the issues at hand, and that will help States prioritize their subsequent decision-making and actions.

Website, listserv, and contact information is as follows:

Questions/Comments/Discussion

Responding to a question, Dr. Nolan said that there is a great deal of State interest in metrics on the costs versus benefits, return on investment, and clinical impact of HIT and HIE but that the Alliance only is beginning to think about how to address this. What States already are doing and the impact will be examined as part of best practices.

Dr. Lumpkin asked whether the State Alliance will address two major areas: how to approach HIT to reduce the burden of private-sector compliance with State mandates, and how compliance with State-mandated reporting, for example, of infectious diseases can be improved.

Dr. Nolan noted the Task Forces will seek input from both the public and private sectors on the issue of burden/impact. Critically, the Health Communication and Data Exchange Task Force will look into how well public-sector HIT is or is not integrating with private sector efforts and how the current dynamic can be improved. Improving reporting compliance can involve the issue of burden and also fits in with NGA’s other, ongoing work on quality improvement. How public health programs and population health management are integrated is important, but the State Alliance may not address that issue immediately.

Dr. Lumpkin commented that the Task Forces’ membership will be important because providers’ overriding interest in how and when they get paid often puts other issues on the back burner.

Responding to a question, Dr. Nolan confirmed that nominees are still being sought for the State Alliance and its Task Forces on a broad, State-relevant basis. She will provide Michael Barr and other members with relevant information, including States currently under represented among nominees under consideration.

Action Item #1 : Dr. Nolan will provide BSV WG members with the State Alliance’s call for nominees’ information and will note States of particular interest to affect broad representation on the State Alliance for e-Health.

2. Proposed Broad Charge for the Expanded Scope of the BSV WG

Dr. Lumpkin noted the document made available for today’s meeting entitled “Proposed Broad Charge for the Expanded Scope.” It includes the current Broad and Specific Charges for the BSV WG as well as the proposed Broad Charge for the WG’s expanded scope. Once approved by the BSV WG, the proposed Broad Charge will be presented to AHIC at its January 23, 2007, meeting for discussion and possible approval.

The current Broad Charge and the proposed Broad Charge are as follows:

• Current Broad Charge: “Make recommendations to the Community to implement the informational tools and business operations to support real-time nationwide public health event monitoring and rapid response management across public health and care delivery communities and other authorized government agencies.”

• Proposed Broad Charge for the Expanded Scope: “Make recommendations to the Community that facilitate the flow of reliable health information between population health and clinical care necessary to protect and improve the public’s health.”

Comments/Questions/Discussion

Steve Solomon said the proposed charge is very consistent with the Centers for Disease Control and Prevention’s (CDC) strategic direction for the future.

Discussion ensued about clarifying what is meant by “population health” in the proposed charge. One member commented that population health is an entity in its own right and has functions that include not only public health but clinical care. One member proposed that the “Background Document for Expanded Scope: Population Health and Clinical Care” with its five domains (see 3 below) be linked explicitly to the proposed charge to emphasize the breadth of population health. It was decided that when the Broad Charge for the Expanded Scope is posted to the AHIC Website, the Background Document for Expanded Scope: Population Health and Clinical Care will accompany it.

There was further discussion of the advisability of listing the five domains from the background document alongside the proposed charge as well as a descriptive paragraph. It was agreed that this might be useful in the Co-chairs’ presentation of the proposed charge to the AHIC. It was decided that a listing of the five domains from the background document and a descriptive paragraph might be useful for the Co-chairs’ presentation of the proposed Broad Charge to the AHIC.

Discussion ensued on clarifying the proposed charge itself, through additional or changed language. The proposed Broad Charge will be revised as follows: “Make recommendations to the Community that facilitate the flow of reliable health information among population health and clinical care systems necessary to protect and improve the public’s health.”

3 . “Background Document for Expanded Scope: Population Health and Clinical Care”

Dr. Lumpkin turned discussion to the background document for the expanded scope and its five domains: Public Health Surveillance and Response, Health Status/Disease Monitoring, Population-based Clinical Care, Population-based Research, and Health Communications/Health Education. He asked for comments on each domain.

Public Health Surveillance and Response Comments/Questions/Discussion

There was discussion of in which domain food safety monitoring belongs, as from the Food and Drug Administration’s (FDA) perspective, this is product-related and therefore should be under Public Health Surveillance and Response rather than the next domain, Health Status/Disease Monitoring. After further discussion, there seemed to be a decision to leave food safety monitoring in the latter domain.

Health Status Disease Monitoring Comments/Questions/Discussion

There was discussion of whether the first bullet in the Public Health Surveillance and Response domain should include “in vital events” after “of public health data” or whether the vital events system should be addressed in a different way in the Health Status/Disease Monitoring domain. It was discussed that the second bullet under the latter domain could be changed from “Attention to the vital statistics…” to “Collection and assessment of vital statistics…” or similar language to be provided by Ed Sondik.

Action Item # 2: Dr. Sondik will review the second bullet of the Health Status/Disease Monitoring domain and provide new language, if necessary, to ensure that it reflects the need to collect and assess vital statistics.

Paula Soper noted ongoing work to develop indicators to uncover the root causes of health care inequities and disparities and asked that this issue area be addressed. It was agreed that this issue area fits under Health Status/Disease Monitoring. The need to uncover the root causes of health care inequities and disparities will be added to the Health Status/Disease Monitoring domain.

Population-based Clinical Care Comments/Questions/Discussion

Concern was expressed that “observation of adverse events” in the fifth bullet under this domain relates to products. Dr. Lumpkin stated that is not the case.

In the context of “evidence-based clinical care” (last bullet point), there was discussion of the need to mention evidence-based clinical care guidelines and measurement and development of best practices systems management. It was decided that evidence-based clinical care guidelines and measurement and development of best practices systems management will be added to the Population-based Clinical Care domain.

It was decided that, in part, because there are/will be crossovers between at least the work of the Quality WG and the new work of the BSV WG, an introductory note should be placed in the document about how the document is intended to serve as a framework for addressing a number of issues. Also discussed was the need for asterisks or some other demarking symbol in the document to denote issues areas being examined by other WGs. Either through an introductory note or the use of asterisks, the BSV WG will acknowledge in the background document that the document addresses a number of issues being examined by other WGs.

Population-based Research Comments/Questions/Discussion

There was discussion of the second bullet point pertaining to the conduct of clinical trials, “… ideally in collaboration with industry, to determine the efficacy and safety of new drugs and biologics that can be used to treat and control drug-resistant infections.” Lisa Rovin agreed drug-resistant infections are a problem but asked why they are mentioned specifically and who would conduct the trials. Dr. Lumpkin suggested that the bullet point be shortened to simply state the need to “facilitate implementation of clinical trials.” It was decided that this statement regarding clinical trials is philosophical; i.e., regardless of who conducts such trials, the WG’s intent is to address the efficacy of infectious disease agents as part of population-based research to improve population health.

Action Item # 3: Dr. Rovin will work with the language in the second bullet point of the Population-based Research domain pertaining to clinical trials to help make its intention clear per the discussion.

It was decided that the second bullet point that refers to developing, evaluating, and monitoring effective vaccination programs should exclude “monitoring” because it is a surveillance activity. “Monitoring” will be removed from the second bullet point in the Population-based Research domain regarding the development and evaluation of effective vaccination programs.

General Discussion

Dr. Lumpkin proposed that monitoring the performance of the public health system be mentioned in the document, following certification, and that it is an issue of timing. Leah Devlin proposed that the document specifically mention monitoring the need for research to be translated into practice. It was commented that the first aspect pertains to how well public health providers are performing, but the second is broader, encompassing the performance of the population health system.

There was further discussion of the need for such overarching issues to be addressed in an introductory paragraph to the document.

There was further discussion about whether such issues, however important they are including research issues relate to the WG’s proposed expanded Broad Charge. Dr. Lumpkin commented that measuring the performance of the public health system is probably outside the BSV WG’s scope, but it bears some comment. If the five domains are to be assessed, measuring public health system performance and the degree of translation of research into practice will be useful. An introductory paragraph to the background document will be fashioned to reflect discussion of overarching issues.

4 . Testimony Needed on Adverse Events Reporting and Response Management

Dr. Lumpkin asked for discussion of testimony needed on the BSV WG biosurveillance priority areas of Adverse Events Reporting and Response Management for the WG’s February and March 2007 meetings. Presentations by experts will help the WG formulate recommendations to AHIC consistent with its earlier identification of four biosurveillance priority areas.

Dr. Lumpkin characterized Adverse Events Reporting as encompassing the electronic submission of reports of many different types of adverse events, including but not limited to nosocomial infections, medication errors, adverse drug events, and adverse events related to medical devices.

Adverse Events Reporting Testimony Discussion

Dr. Lumpkin asked for presentation proposals on Adverse Events Reporting for the February (February 2, 2007) BSV WG meeting.

After discussion, it was decided that the FDA, the CDC, the Centers for Medicare and Medicaid Services (CMS), and the National Institutes of Health (NIH) in that order will be asked to provide presentations on Adverse Events Reporting. Relevant State associations also will be asked to present on Adverse Events Reporting, in the context of a State-level panel. Representatives from the American Hospital Association (AHA), the American Medical Association (AMA), and the Veterans Administration (VA) will be asked to present on Adverse Events Reporting as part of a provider panel.

Action Item #4: In addition to helping provide FDA testimony on Adverse Events Reporting, Dr. Rovin will provide NIH contact information.

Action Item #5: In addition to helping provide CDC testimony on Adverse Events Reporting, Dr. Solomon will help identify a State to give a presentation on State-level collection of medical error data.

Also discussed were presentations from the National Commission on Quality Assurance (NCQA) and the Joint Commission on Accreditation of Healthcare Organizations. It seemed to be decided that representatives of the NCQA and the Joint Commission on Accreditation of Healthcare Organizations would also be asked to present on Adverse Events Reporting.

There was discussion of asking for two-thirds of each presentation on Adverse Events Reporting to be devoted to current activities and one-third to be devoted to envisioned or planned future activities, the latter of which are expected to be particularly useful to future BSV WG recommendations. It was agreed that two-thirds of each Adverse Events Reporting presentation should be devoted to current activities and one-third should be devoted to envisioned or planned future activities.

Response Management Testimony Discussion

Dr. Lumpkin asked for presentation proposals on Response Management for the March 2, 2007, BSV WG meeting. He characterized Response Management as an area that includes multiple aspects of response from outbreak investigation to collecting and monitoring bed and resource availability data to helping to inform clinical decision making and managing countermeasures. This may include use of different types of registries ranging from specific immunization registries to registries of emergency response personnel and registries of people given countermeasures who then require longer-term follow-up.

Areas for testimony already discussed include countermeasure delivery and apportionment, stockpile distribution and management, contact tracing and outbreak management, isolation and quarantine systems, and event registries.

Dr. Solomon noted that the CDC has a broad and growing portfolio in all these areas and will work with WG staff on structure of a presentation and resources for the March meeting. There was discussion of contacting the emergency response staff of the Secretary’s office and also asking for a presentation from the Department of Homeland Security (DHS). The CDC will propose the outlines of its presentation on Response Management for the March meeting to BSV WG members via e-mail to solicit their contributions. Co-chairs and ONC staff also will participate to facilitate communications.

Action Item #6: ONC staff will contact the Secretary’s emergency response staff and DHS per discussion of Response Management presentations for the March meeting.

5 . Timeline for the BSV WG Letter of Recommendation to AHIC

Priority setting discussions at the AHIC’s January 23, 2007, meeting are expected to inform the BSC WG’s current draft Letter of Recommendation. Therefore, ONC staff will work to revise the Letter following the meeting and communicate revisions to members by the end of January so that it can be discussed further at the BSV WG’s February meeting and finalized by February 16 for presentation to AHIC at its March 6, 2007, meeting.

Action Item #7: As needed following the AHIC’s January 23, 2007, meeting, ONC staff will revise the BSV WG’s current draft Letter of Recommendation and communicate revisions to members by the end of January.

6 . Next Steps

A. Co-chairs Dr. Lumpkin and Dr. Kahn will make a presentation at the AHIC’s January 23, 2007, meeting on the BSV WG’s Proposed Broad Charge for the Expanded Scope.

B. The February BSV WG meeting is set for February 2, 2007, from 10 a.m. to 3:30 p.m., and the agenda will include discussion of the Letter of Recommendation (see 6) and presentations on Adverse Events Reporting (see 5). Members were asked to attend in person if possible. Members should send their questions for presentations to ONC staff as soon as possible, given the mid-January 2007 deadline for presentation questions to be submitted to and published in the Federal Register.

ONC staff will seek to secure a larger meeting room for the February 2, 2007, meeting.

Action Item #8: BSV WG members should plan to attend the February 2, 2007, meeting in person if possible and send their questions for presentations on Adverse Events Reporting to ONC staff as soon as possible.

Action Item #9: ONC staff will seek to secure a larger meeting room for the February 2, 2007, meeting.

C. The March BSV WG meeting is set for March 2, 2007, from 10 a.m. to 3:30 p.m., and the agenda will include presentations on Response Management. Members were asked to attend in person if possible.

ONC staff will seek to secure a larger meeting room for the March 2, 2007, meeting.

Action Item #10: BSV WG members should plan to attend the March 2, 2007, meeting in person if possible.

Action Item #11: ONC staff will seek to secure a larger meeting room for the March 2, 2007, meeting.

8. Public Comments

None.

SUMMARY OF ACTION ITEMS

Action Item #1: Dr. Nolan will provide BSV WG members with the State Alliance’s call for nominees’ information and will note States of particular interest to affect broad representation on the State Alliance for e-Health.

Action Item # 2: Dr. Sondik will review the second bullet of the Health Status/Disease Monitoring domain and provide new language, if necessary, to ensure that it reflects the need to collect and assess vital statistics.

Action Item # 3: Dr. Rovin will work with the language in the second bullet point of the Population-based Research domain pertaining to clinical trials to help make its intention clear per the discussion.

Action Item #4: In addition to helping provide FDA testimony on Adverse Events Reporting, Dr. Rovin will provide NIH contact information.

Action Item #5: In addition to helping to provide the CDC with testimony on Adverse Events Reporting, Dr. Solomon will help identify a State to give a presentation on State-level collection of medical error data.

Action Item #6: ONC staff will contact the Secretary’s emergency response staff and DHS per discussion of Response Management presentations for the March meeting.

Action Item #7: As needed following the AHIC’s January 23, 2007, meeting, ONC staff will revise the BSV WG’s current draft Letter of Recommendation and communicate revisions to members by the end of January.

Action Item #8: BSV WG members should plan to attend the February 2, 2007, meeting in person if possible and send their questions for presentations on Adverse Events Reporting to ONC staff as soon as possible.

Action Item #9: ONC staff will seek to secure a larger meeting room for the February 2, 2007, meeting.

Action Item #10: BSV WG members should plan to attend the March 2, 2007, meeting in person if possible.

Action Item #11: ONC staff will seek to secure a larger meeting room for the March 2, 2007, meeting.

Meeting Materials

Agenda

Meeting Goals

Briefing on the State Alliance for e-Health - Kathleen Nolan, National Governors Association

Proposed Charge

Biosurveillance Workgroup

Members and Designees Participating in the Web Conference

January 5, 2007

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