Minutes of the March 3-4, 2005 NCVHS Full Committee Meeting

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

March 3-4, 2005

Hubert H. Humphrey Building
Washington, D.C.

Meeting Minutes

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The National Committee on Vital and Health Statistics was convened on March 3-4, 2005 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:

Committee members

[*new ; ** outgoing]

Simon P. Cohn, M.D., M.P.H., FACP, Chair

Jeffrey Blair, M.B.A.

Justine M.Carr, M.D.

Richard K. Harding, M.D.

John P. Houston, Esq.

Stanley M. Huff, M.D.

Robert W. Hungate

Eugene Lengerich, V.M.D. **

A. Russell Localio, Esq., M.A., M.P.H., M.S.

John R. Lumpkin, M.D., M.P.H. **

Vickie Mays, Ph.D. **

Carol J. McCall *

Harry Reynolds

Mark A. Rothstein, J.D.

William J. Scanlon, Ph.D. *

Donald M. Steinwachs, Ph.D.

C. Eugene Steuerle, Ph.D.

Kevin C. Vigilante, M.D., M.P.H.

Paul Tang, M.D. *

Judith Warren, Ph.D, RN

Absent:

Peggy B. Handrich **

Staff and liaisons

Marjorie Greenberg, NCHS/CDC, Executive Secretary

James Scanlon, ASPE, Executive Staff Director

J. Michael Fitzmaurice, Ph.D., AHRQ liaison

Karen Trudel, CMS liaison *

Judith Berek, CMS liaison **

Virginia Cain, NIH liaison

Ed Sondik, Ph.D., NCHS liaison

Steve Steindel, Ph.D., CDC liaison

Aldona Robbins, NCHS BSC liaison **

Others

Katherine Jones, NCHS

Debbie Jackson, NCHS

Marietta Squire, NCHS

Mary Jo Deering, NIH

Maria Friedman, CMS

Sue Bowman, AHIMA

Michelle Ferrito, DEA

Marilyn Zigmund Luke, AHIP

Steven Bruck, PEC Solutions

Kelly Lavin, American Osteopathic Association

Patricia Watts, VA

Frank Kyle Jr., ADA

Laura Vartain, Wexler & Walker

Carol Bickford, ANA

Suzie Burke-Bebee, ASPE

Phillip Rothermich, Express Scripts

Stan Edinger, AHRQ

Edna Paisano, HIS

Suzanne Haynes, OPHS

Vivian Auld, NLM

Randy Levin, FDA

Ken Hoffman, SAMHSA

Angela Franklin, BCBSA

Miryam Granthon, OMH

Greg Thornton, Competech Smartcard Solutions

Audrey Burwell, OPHS

Michael DeCarlo, BCBSA

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ACTIONS

1. The Committee passed a motion to write a letter to the CMS Administrator thanking Judith Berek for her service as CMS liaison.
2. Privacy Letter on Medical Devices: This letter arose out of hearings held jointly by the Privacy and Standards Subcommittees. It was read aloud and discussed. Based on the Committee’s discussion, the Subcommittee on Privacy and Confidentiality revised the letter and presented it on day two of this meeting, when it was approved as revised.
3. Letter on e-Prescribing: The co-chairs presented the thinking behind this letter, the observations and the recommendations. Following lengthy discussion, the Subcommittee on Standards and Security revised the letter and presented it on day two, when it was approved as revised.
4. Letter Commenting on CMS e-Prescribing Proposed Rule: Mr. Blair explained that this letter is based on the format of the NPRM, and others on e-Prescribing would be forthcoming. The Committee approved the letter, with one minor modification.

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EXECUTIVE SUMMARY

New NCVHS Chair Simon Cohn, M.D., chaired the meeting. He welcomed the following new members: Carol McCall, William Scanlon, Ph.D. and Paul Tang, M.D. Karen Trudel was welcomed as the new CMS liaison. The Committee expressed appreciation to the following outgoing members (to whom Dr. Michael O’Grady, Asst. Secretary for Planning and Evaluation, presented certificates on behalf of the Secretary):

• Dr. John Lumpkin
• Dr. Vickie Mays
• Dr. Eugene Lengerich
• Peggy Handrich (not present)

Dr. Cohn acknowledged the leadership and contributions of outgoing Chair Dr. John Lumpkin, and commented on the present time of transition. The Committee also acknowledged outgoing CMS liaison Judy Berek. (Aldonna Robbins, outgoing liaison from the NCHS Board of Scientific Counselors, was acknowledged on day two, prior to her presentation.) Dr. Cohn offered thoughts about the transition and announced new Subcommittee and Workgroup chairs. All groups except Subcommittee on Standards and Security (which will have co-chairs) are encouraged to appoint vice-chairs.

Update from the Department

• Data Council Responses to NCVHS Reports and Recommendations—James Scanlon, ASPE

Mr. Scanlon reported on the new HHS Secretary and privacy advisor, planning for the FY06 budget, the FY05 budget and increased funding for NCHS, and several Data Council program review and data initiatives. The latter include initiatives on prescription drug data, national health insurance data, state and local data, and income and wealth-related survey data

• HHS Implementation of PL 104-191 Health Insurance Portability and Accountability Act of 1996 Privacy Rule Compliance Update—Susan McAndrew, OCR 

Ms. McAndrew reported on new FAQs on the OCR Website, the status of compliance, changes in the privacy team, and OCR’s appreciation for hearings held by the Subcommittee on Privacy and Confidentiality.

During the discussion period, NCVHS members commented or asked questions about the Committee’s requests for statistics on complaints, the possibility of exploring the impact of the privacy rule on PHR systems, and prospects for cost-benefit analysis of the privacy rule.

• Data Standards, Including Clinical Data Standards Adoption CHI Update—Karen Trudel, CMS

Ms. Trudel reported on the release of the first in a series of e-prescribing proposed rules, as well as on plans for pilot testing, the security rule compliance deadline, and the NPI.

In the discussion period, the group discussed a proposal to link the Department’s responses to the Committee’s letters and reports on the NCVHS Website as well as the relationship between CHI and FHA and issues related to formulary and benefit medication history.

Privacy Letter on Medical Devices—Mark Rothstein

(See Actions, above.)

Letter on e-Prescribing—Jeff Blair, Harry Reynolds

(See Actions, above.)

Letter Commenting on CMS e-Prescribing Proposed Rule—Jeff Blair, Harry Reynolds

(See Actions, above.)

Status of Populations Report—Donald Steinwachs, Vickie Mays

The Quality Workgroup and Population Subcommittee plan to coordinate their work . The Subcommittee will present a report to the Committee in June. It will have three overarching recommendations, concerning standards, methodological research and infrastructure. Committee members offered suggestions for the report.

2003-2004 Annual Report; HIPAA Report to Congress—Simon Cohn, Marjorie Greenberg

As agreed at the November 2004 meeting, the section of the 2003-2004 report addressing the research agenda will include only those recommendations that are already in NCVHS letters and reports. The report will be circulated to the Executive Subcommittee for review in advance of the June meeting, when it will be on the agenda for approval.

The Committee agreed that the HIPAA report should be timed to permit comment on the implementation of the security rule. Staff will circulate a rough draft by June. The report is tentatively scheduled for approval at the September meeting.

National Health Information Technology Update—David Brailer

Dr. Brailer spoke about ONCHIT’s alignment with other groups, including NCVHS; the status of the National Health Information Network RFI process; and ONCHIT’s activities with respect to four aspects of its strategic framework:

• the adoption gap between large and small practices and hospitals
• technical harmonization among standards and organizational processes
• business process harmonization
• privacy

He also discussed the Federal Health Architecture (FHA), following up on a January 2005 letter he sent to NCVHS asking this question: “How can we integrate this more directly with what is happening in the private sector, and how can we make this activity a more meaningful state-of-the-art activity?”

During the discussion period, NCVHS members commented and raised questions about consumer involvement in ONCHIT’s processes, the prospects for better integrating the population dimension, the forthcoming summary of RFI responses (expected in Summer 2005), and the need to build public trust about privacy and understanding of the benefits of EHRs and PHRs.

Comments by John Lumpkin, Outgoing Chair

Dr. Lumpkin, in his final remarks to the Committee, commented on the extraordinary changes and growth in the health information policy environment since 1996. He noted the Committee’s accomplishments and impact in recent years, and said most of the credit goes to the central role of its subcommittees and workgroups and to the critical contributions of its staff and liaisons. Dr. Cohn expressed appreciation for Dr. Lumpkin’s six years of leadership as Chair and eight years of service as a member.

NCHS Update—Dr. Sondik

Dr. Sondik discussed the implications of the CDC reorganization for NCHS, recent and forthcoming budgetary changes and issues, priorities for modernizing the vital statistics system, and the impact of staff reductions.

Noting the current time pressures, Dr. Cohn said the Committee hopes to have a longer conversation with Dr. Sondik in June or September—e.g., on redundant data collection (Dr. Sondik suggested inviting Kathy Wallman of OMB to participate), and on classifications.

Report From Board of Scientific Counselors (BSC)—Dr. Robbins

Dr. Robbins reported that the BSC has moved from organizing to doing work. It will be assisting in the NCHS internal review. During the discussion period, NCVHS members raised questions about improving access to administrative data and informing consumers about the uses of survey data.

Federal Initiatives in Geocoding—Dan Melnick, Andrew Dent, CDC

Dr. Melnick spoke on the project initiated in 2003 under Data Council auspices to increase user-friendly access to statistical and data holdings. It relates to both the HHS Gateway to statistical resources and to new uses of geographic information. He is a consultant on this project. He encouraged NCVHS members to use the resources and to suggest ways they can be improved.

Mr. Dent described the Geographic Research, Analysis, and Services Program at CDC, and offered vignettes on how geocoding is being applied at CDC to support and enhance its programs. Dr. Melnick explained that this is one application of GIS to a CDC analysis system.

NCVHS members asked about who can use these services, the extent of international involvements, and the potential use of GIS methodology with respect to homeless populations.

Reports from Subcommittees and Workgroups and Future Agendas
(See brief descriptions at the end of the detailed summary below.)  

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DETAILED SUMMARY

—Day One—

Call to Order; Welcome and Introductions; Review of Agenda—Simon Cohn, Chair

On behalf the Committee, new NCVHS Chair Simon Cohn acknowledged the leadership and contributions of outgoing Chair Dr. John Lumpkin. He also welcomed new members Carol McCall, William Scanlon, Ph.D., and Paul Tang, M.D., as well as Karen Trudel as the new CMS liaison. The Committee expressed appreciation to these outgoing members:

• Dr. John Lumpkin
• Dr. Vickie Mays
• Dr. Eugene Lengerich
• Peggy Handrich (not present)

Dr. Michael O’Grady, Asst. Secretary for Planning and Evaluation, visited the meeting in mid-morning and presented the outgoing members with certificates of appreciation on behalf of the Secretary. He also welcomed the new members.

The Committee also acknowledged outgoing CMS liaison Judy Berek and passed a motion to write a letter to the CMS Administrator thanking her for her service. Aldonna Robbins, outgoing liaison from the NCHS Board of Scientific Counselors, was acknowledged on day two, prior to her presentation.

Dr. Cohn commented on the period of transition and announced new Subcommittee and Workgroup chairs. Jeff Blair and Harry Reynolds are co-chairs of the Subcommittee on Standards and Security, and Dr. Don Steinwachs will chair the Subcommittee on Populations.

Update from the Department

• Data Council Responses to NCVHS Reports and Recommendations—James Scanlon, ASPE

Mr. Scanlon briefed the Committee on personnel changes at HHS, FY06 budget planning, and Data Council activities. The new Secretary, Michael Leavitt, is savvy about information policy and IT and interested in moving this agenda forward. Maya Bernstein has been hired as the new HHS Privacy Advisor.

On the budget, the President’s FY06 budget contains several HIT investments, with $75 million for ONCHIT to provide strategic direction and $50 million for AHRQ.

The budget will sustain increases for NCHS funding that began in FY05. This was a top Data Council priority, to shore up surveys and major data systems.

The Data Council is looking into four areas to assess current data activities and gaps, needed enhancements and collaborative opportunities:

• Prescription drug data (associated with the Medicare Modernization Act (MMA), Part D program)
• National health insurance and related data  (e.g., looking for a comparative framework across surveys)
• State and local data capabilities (starting with health insurance data)
• Income and wealth-related survey data (particularly, how these variables are measured)

• HHS Implementation of PL 104-191 Health Insurance Portability and Accountability Act of 1996 Privacy Rule Compliance Update—Susan McAndrew, OCR  

There are three new FAQs on the OCR Website. OCR has received 11,258 complaints of which 63 percent have been closed. OCR has referred 170 “egregious” cases of breaches of confidentiality to the Justice Department. Staff members appreciated the hearings of the Subcommittee on Privacy and Confidentiality and are looking forward to the next ones. Finally, staff changes are under way in the privacy team at OCR. Ms. McAndrew said she hoped the new staff would help in producing the statistics the Committee has asked for.

• Discussion

Asked about possible changes in the privacy rule, she said the Department is “always looking at changes,” especially now that two years have passed since the rule went into effect. Asked about the possibility of exploring the impact on PHR systems, she said OCR is working closely with ONCHIT on the rollout of the EHR and NHII, and these discussions may encompass PHRs. Most PHRs are covered by HIPAA through a business associate relationship, although information obtained directly from the consumer is outside the rule’s purview and a statutory change is needed to change that relationship. In response to a query about the prospects for cost-benefit analysis of the rule’s impact, Mr. Scanlon said this would require an interagency effort, and there is a proposal in ASPE to look at the metrics and data needed for such an analysis. To a follow-up question, Ms. McAndrew said the new OCR staff may “possibly” take the lead on a cost-benefit analysis. Mr. Rothstein referred to a past NCVHS letter recommending studies to measure the costs and effectiveness of HIPAA.

• Data Standards, Including Clinical Data Standards Adoption CHI Update—Karen Trudel, CMS

The comment period on the proposed rule for e-prescribing ends on April 5. Ms. Trudel noted the Committee’s role in e-prescribing as set out by the MMA, noting that the hearing process it used is “a model of public-private consultation and a shining example of what a federal advisory committee is supposed to do.” The proposed regulation sets out “foundation standards” or building blocks for entering an e-prescribing environment. Other functionality will be layered on top. There will be an effort to make these standards interoperable with others. After noting that state preemption is a significant issue addressed in the proposed rule, she elaborated on the three foundation standards, each of which is an established standard. In general, the Department’s criteria in selecting standards include that they be accredited by and SDO and permit interfaces with multiple products and vendors. It solicited comments on its criteria and on specific standards under consideration. She added that the Subcommittee on Standards and Security will continue to monitor progress, and she stressed that the first set of standards is not the full set necessary for e-prescribing. Another issue discussed in the regulation is the use of the National Provider Identifier (NPI) and the potential impact of accelerating the NPI for use in e-prescribing. On pilot testing, Ms. Trudel noted that it is required in 2006, and CMS will soon solicit applications. The structure of the pilots will generally follow NCVHS recommendations.

Turning to the security compliance deadline of April 20, she noted that compliance and enforcement of the security and privacy rules are closely linked. The process for both is complaint driven, not audit driven. The Department is working on “one-stop shopping” so complainants do not have to work out whether something is a privacy or security complaint but either can be submitted to the same designated authority in HHS. Compliance with the security rule is moving along well.

Finally, on the NPI Ms. Trudel noted that the regulation is effective in May and the compliance date is May, 2007. An enumerator contractor is working on system testing.

• Discussion

In response to a question, Ms. Trudel said JCAHO and Security Rule complaint processes would be kept separate.

Mr. Rothstein proposed that the NCVHS Website be revised to link its letters to the Secretary with the Secretary’s responses, to make it easier for Committee members and the public to track what happens as a result of NCVHS recommendations. Mr. Scanlon said the Department would look into this. Dr. Cohn commented that the Executive Subcommittee can also monitor the Department’s responses to recommendations.

The group briefly discussed the relationships among the CHI initiative and the Federal Health Architecture (FHA). There will be a presentation on the latter (which encompasses the former) at the June meeting. Ms. Trudel noted that the FHA’s Program Management Office is being run from ONCHIT.

In response to another question, Ms. Trudel commented further on the prospects for changes to the e-prescribing standards following the comment period.

Privacy Letter on Medical Devices—Mark Rothstein

Mr. Rothstein presented a draft letter that arose out of hearings held jointly by the Privacy and Standards Subcommittees. He read the letter aloud, and members commented and asked questions. One issue that received particular attention is the need to strengthen efforts to educate providers about security risks to medical devices and providers’ responsibilities in that regard. Based on the Committee’s discussion, the Subcommittee on Privacy and Confidentiality subsequently revised the letter for presentation on day two of this meeting.

Letter on e-Prescribing—Jeff Blair, Harry Reynolds

(Further detail on this complex discussion can be found in the March 3 transcript, starting on page 79.)

Mr. Blair noted that the Committee provided its initial recommendations on e-prescribing standards in September 2004. The letter on hand now focuses on particularly challenging areas, using a combination of observations and ten recommendations, which Mr. Reynolds read aloud. Committee members were invited to comment on substantive matters. The group talked at length about authentication issues. The importance of coordination between HHS and DEA was also stressed. Prompted by a discussion of e-signature issues, the Committee also agreed to add to its workplan a comprehensive look at the question of how to securely identify people and places in an electronic world. The final observation and set of recommendations pertains to privacy issues and is based on a hearing by the Subcommittee on Privacy and Confidentiality. The group agreed that a future recommendation in a future letter should address the links between medication history and privacy issues.

Dr. Steinwachs suggested that the Committee look into the patient side of knowledge about prescriptions, since existing knowledge bases are primarily for pharmacists and physicians. The matter was referred to the NHII Workgroup in the context of its work on the personal health dimension. The possibility of holding hearings on this issue was raised.

A query about the potential impact of e-prescribing on the relative responsibilities and possibility liabilities of the prescriber and the dispenser generated considerable discussion.

Following this discussion, the Subcommittee revised its letter, for presentation on day two.

Letter Commenting on CMS e-Prescribing Proposed Rule—Jeff Blair; Harry Reynolds

Mr. Blair explained that the format of this letter is based on the format of the NPRM. Mr. Reynolds then read the letter aloud. Following minor wordsmithing, the Committee passed a motion approving the letter. Dr. Cohn noted that there will be a series of letters in the future on e-prescribing to comment on pilots and other matters.

Motion Thanking Judith Berek

To mark the departure of Judith Berek as CMS liaison, the Committee passed a motion that a letter be sent to the CMS Administrator thanking her for her service.

Status of Populations Report—Donald Steinwachs, Vickie Mays

Dr. Steinwachs reported that the Quality Workgroup and Population Subcommittee plan to coordinate their work more closely in the future. The Subcommittee hopes to present a report on health disparities to the Committee in June. Dr. Mays added that the report will have three overarching recommendations, concerning standards, methodological research and infrastructure. After acknowledging the support of Jennifer Madans in the background work for the report, she read aloud the first set of recommendations on standards and entertained comments from the group. Dr. Mays encouraged members to send further suggestions to the Subcommittee on Populations. Dr. Cohn praised the fact that the recommendations appear to be actionable and are a manageable number.

Comments on the Role of Staff—Dr. Cohn

Returning to his introductory remarks on the effectiveness of the Committee, Dr. Cohn acknowledged the critical contributions of the staff of the full Committee and its subcommittees and workgroups. The Committee responded with applause. Ms. Greenberg noted that it is a good partnership. Dr. Cohn then said the Executive Subcommittee would be looking for ways to make the workload better for everyone. He encouraged the new members to be as active as possible, and recommended that all subcommittees and workgroups have vice-chairs (except Subcommittee on Standards and Security, which will have co-chairs).

2003-2004 Annual Report; HIPAA Report to Congress—Simon Cohn, Marjorie Greenberg

Ms. Greenberg reported that the staff has been compiling research proposals from past NCVHS reports for the Committee’s forthcoming two-year report. As agreed at the November 2004 meeting, the section addressing the HHS information policy research agenda will include only those recommendations that are already in NCVHS letters and reports. The Committee has the option in the future of elaborating on the research implications of its other recommendations. The 2003-2004 report will be circulated to the Executive Subcommittee for review in advance of the June meeting, when a draft based on that stage of review will be on the agenda for discussion and approval. Ms. Kanaan plans to interview all subcommittee and workgroup chairs in preparing the report.

Dr. Cohn noted that the Committee is responsible under HIPAA for an annual report to Congress on HIPAA implementation. This is a combined effort of the Standards and Privacy Subcommittees.  Mr. Scanlon said staff would pull together the factual developments on HIPAA and the Committee can decide what issues it wants to raise. A rough draft will be circulated by June. The report is tentatively scheduled for approval at the September meeting, or possibly later. The group agreed that the HIPAA report should be timed to enable comment on the implementation of the security rule.

In response to a question from Mr. Blair about whether to use the HIPAA implementation report as an opportunity to discuss related matters such as Committee’s PMRI and CMI work, members accepted Mr. Scanlon’s advice to stay with the original intent of Congress for this report. Dr. Cohn said he thinks of HIPAA as “phase 1” and clinical data standards as “phase 2” in an evolutionary process that builds on the HIPAA foundation. He added that another issue that might be addressed is the business value that is starting to emerge for HIPAA.

National Health Information Technology Update—David Brailer

Dr. Brailer began by extending his personal thanks to Dr. Lumpkin for his service as NCVHS chair and welcoming Dr. Cohn as the new Chair. He then briefed the Committee on these topics:

• ONCHIT’s alignment with other groups, including NCVHS
• the National Health Information Network (NHIN) RFI process
• ONCHIT’s strategic plan
• Federal Health Architecture (FHA)

The work on aligning with other groups is being conducted through the Commission for Systemic Interoperability. The Commission has met twice and is exploring challenges related to consumer aspects and standardization. In addition, ONCHIT and CMS have ex-officio seats on a private sector group, the Certification Commission for Health Information Technology, which is developing specifications for a minimally-featured EHR.

ONCHIT has received all the responses to the RFI it put out on the NHIN. For example, it is trying to define what is needed to allow active interoperability between EHRs. The RFI asks questions about where the money comes from, how the infrastructure would operate and by whom, the technology issues and gaps, and so on. The questions are on the ONCHIT Website. It received 540 responses from organizations and more than 500 from individuals. ONCHIT has assembled a federal task group of about 150 federal employees to compile the responses and create a meta-analysis. After it is reviewed internally, it will be made public. (22 responses were made public by the responders.)

ONCHIT has had more than 300 meetings and conferences to discuss its Framework for Strategic Action. It expects to address four issues as it moves forward in the coming year:

• the adoption gap between large and small practices and hospitals
• technical harmonization among standards and organizational processes
• business process harmonization
• privacy

Regarding the FHA, Dr. Brailer noted that he had written the Committee in January 2005 asking this question: “How can we integrate this more directly with what is happening in the private sector, and how can we make this activity a more meaningful state-of-the-art activity?” The idea is to harmonize federal information systems with systems and practices outside the federal government. ONCHIT is asking for the Committee’s review and input on these issues. He noted that in all these efforts, ONCHIT enjoys the support of the President and the Secretary.

Discussion

Dr. Steinwachs asked how ONCHIT is trying to engage consumer groups in its processes. Dr. Brailer described three classes of activities involving consumers: regional initiatives, consumer group input through the RFI (indicating it is on their radar screens), and conferences and meetings on the consumer front. He said consumers are looking for “a true person-centric approach.” A strong message concerns data control and ownership, going beyond privacy to issues of autonomy and trust.

Dr. Cohn asked about activities in the population dimension. Dr. Brailer said this is less well defined, which is why ONCHIT has sought input from NCVHS. The question is how to make use of information to change the way the monitoring and correction of public health deficits are approached. He urged the Committee to provide clarity, definition, a roadmap, or “at least a set of the key questions that should be addressed” so the infrastructure is set up to advance population health monitoring and improvement. He added that several population health organizations and advocates responded to the RFI with questions such as these, and this is a time for important dialogue.

Regarding a document summarizing the RFI responses, Dr. Brailer said he intends a substantive document, not “brochure ware.” One question for ONCHIT as it assesses technical gaps is whether they are building with something off-the-shelf or have to do fundamental R&D to solve the problems. Individual responses are protected to protect trade secrets. He said he was unable to predict when the report would be released, but it has high priority. After release (possibly summer 2005), another process of analysis will begin, combined with public debate.

Mr. Blair noted the concerns about privacy in the general public, juxtaposed with differing views of the benefits of EHRs and PHRs. Dr. Brailer affirmed that the RFI responses show these concerns, but there is also a consistent finding over the past decade of a growing awareness of the potential benefits of electronic systems. He characterized this as a horse race, and stressed the need to understand and define the core issues, adding that it is difficult to define the relative privacy risks from electronic and paper health records. The tradeoff is between privacy versus quality and access, and the question is how to frame the debate constructively.

Dr. Cohn said the Committee would begin to talk about the FHA in June, and that the Committee should be able to provide assistance on technical harmonization and the FHA.

The Com mittee then recessed into subcommittees and workgroups, to reconvene on day two.

Day Two

Comments by John Lumpkin, Outgoing Chair

Dr. Lumpkin noted the extraordinary changes in technology in the 55 years of the Committee’s existence, and the significant impact of HIPAA (then AKA “Kennedy-Kassebaum” or “K2”) starting in 1996. The Committee could not have accomplished what it has since then without the combined efforts of every subcommittee and workgroup and all the staff members. The review for GSA found that more than 70 percent of the Committee’s recommendations have been adopted by the Department, partly because of the partnership between the Committee’s staff and members. NCVHS has aided the Department in developing their mission and vision through a collegial partnership, not through antagonism. The paradigm has changed from enforcement to leadership by example, as in the CHI Initiative. And where HHS and the federal government lead, others will follow. Now the President is campaigning for health IT. In the future, people looking back on this period will see the work of NCVHS as transformational, not just for health IT but for healthcare and for the health of the nation. All NCVHS members should know that working on this Committee will make a difference to everyone in the country. Finally, Dr. Lumpkin gave special thanks to Mr. Scanlon, Ms. Greenberg, Dr. Deering, Dr. Braithwaite, Ms. Trudel, and all the staff of the Department.

Dr. Cohn again expressed appreciation for Dr. Lumpkin’s contributions and leadership during his eight years as an NCVHS member and six years as “a superb Chair.”

NCHS Update—Dr. Sondik

Dr. Sondik observed that it had been an eventful year for NCHS, programmatically and administratively. He commented first on “the new, reorganized CDC,” noting that NCHS is part of a coordinating center responsible for providing a more effective link to the customer, including the public and professionals. Directors for the Centers for Health Marketing and Public Health Informatics have yet to be appointed. The reorganization reduces the number of people who report directly to the CDC Director. NCHS will play a critical role in monitoring progress toward programmatic goals and also will have independence as a federal statistical agency. The goals link to the prevention agenda embodied in Healthy People.

A significant change for NCHS this year was increased budgetary finding, as noted above. It went up in recent years, it did not do so enough to keep pace with the cost of running NCHS, so there have been significant cutbacks. The latest unprecedented increase of $20 million prevents more erosion of NCHS programs. Dr. Sondik attributed the increase to strong support from the Data Council and the Department. It will allow NCHS to continue to modernize the vital statistics system, restore the sample size of the National Health Interview Survey and to have full field operations for NHANES and the National Health Care Survey. The Center lost about 30 staff members through buyouts. The reengineering of the vital statistics system is progressing. The birth side in pretty good shape, but the mortality side suffers. He said he would like to bring this issue to the Committee in the future. He noted grant programs under the Intelligence Reform Act that could have a positive effect on the vital statistics system if they were funded.

Dr. Sondik then presented a few findings from various surveys and further details of plans for future surveys.

Report From the Board of Scientific Counselors (BSC)—Dr. Robbins

Dr. Robbins reported that the BSC has moved from organizing to “doing some work.”

Noting that she has tried to share with the BSC the work of NCVHS, she observed that electronic record keeping and vital statistics fit well together. The BSC plans to assist NCHS in the internal review of its programs. It will look at the mission, goals, objectives and activities of every program and at how resources are being allocated. It will also look at measures of productivity and at data usage, and assess program strengths and weaknesses and finally the relevance of the program to current presidential and congressional priorities.

• Discussion

Dr. Steuerle noted the tremendous amount of information that is already gathered, such as administrative data, and the dilemma of the difficulty of gaining access to administrative data for the statistical community. He asked whether the BSC might confront this issue. Dr. Sondik commented on the balance of benefits and potential costs from access to administrative data, and he and Mr. Scanlon described current instances of statistical matching and use of administrative data, especially that maintained by Medicare. IRS data is less accessible. NCHS uses its research data center.

Dr. Cohn said the Committee would invite Dr. Sondik back in June or September for a longer conversation. He proposed a briefing on the reasons behind the redundancies in data collection, and a discussion of classifications. Dr. Sondik suggested that Katherine Wallman of OMB be part of that discussion.

Federal Initiatives in Geocoding—Dan Melnick, Andrew Dent, CDC

Mr. Scanlon said Dr. Melnick was a consultant on a project initiated in 2003 under Data Council auspices to increase user-friendly access to the statistical and data holdings of HHS and other federal agencies. The effort has been coordinated with a government-wide OMB initiative to standardize the way geospatial data are coded and identified.

Dr. Melnick described a number of new resources associated with this project.  He noted the rich body of information reported about health and vital statistics. Another factor is a new requirement from the Federal Geographic Data Committee (FGDC) requiring the Department to report metadata about statistical resources to that Committee, including reports about geographically-referenced material. DHHS does not map geography, but many reports include information about geographic areas. FGDC has formed a clearinghouse, and everything provided to the FGDC clearinghouse will also be reflected in the Geospatial One Stop. Dr. Melnick’s project was to compile metadata for these resources to comply with FGDC standards.

It used the HHS Gateway to Data and Statistics to do so (in the process enriching the gateway based on the FGDC standards). The Gateway, which is driven by an online catalogue, is not yet finished. A key feature is that it tags data resources and enables information-seekers to go to the site where the data reside, where they can also get information on methodology, limitations, access restrictions and other factors. Dr. Melnick encouraged the Committee to use the Gateway resources and to suggest ways they can be improved. Asked later to explain the relationship between his presentation and Mr. Dent’s, Dr. Melnick said Mr. Dent would describe one application of GIS to a CDC analysis system. “Andy’s got the books and we’ve got the card catalogue.”)

Mr. Dent is with the Geographic Research, Analysis, and Services Program (GRASP), an interdisciplinary group that provides GIS analytical support for all CDC centers.  He discussed how geocoding works and how it is being applied at CDC, and presented vignettes to illustrate its utility. GIS can be used to characterize populations, visualize patterns, and layer data, among other things. Complex data can be presented through the use of maps. The GRASP program began in 1988 through a joint program with EPA and DOE that focused on site-specific work at hazardous waste sites. Now it works on several types of surveillance and research.

Geocoding is the process of developing coordinate information (e.g., latitude/longitude) based on geographically-referenced data. There are three main ways to geocode, using a street center line, mile markers and latitude/longitude. Mr. Dent gave an example of the Metro Atlanta Birth Defects Project, which links air quality data to birth defect health outcome data. GIS typically is partnered with a surveillance system. He gave another example of a train wreck, in which information on the location of the wreck would be geocoded and attached to other geographic information, such as on the number and location of hospitals, senior-care and daycare facilities and schools, and the number of people in the vicinity of the event. Finally, he said HIPAA will govern the identifiable pieces of information.

• Discussion

Asked who is able to use the GRASP service, Mr. Dent said it works for all parts of CDC, for state partners, and sometimes for non-governmental organizations. The use would have to have public benefit. To another question about international involvements, he said the program has less information about the rest of the world than it does about the U.S. — for example, it lacks the rich SES data available on the U.S.

Dr. Lengerich and Mr. Dent discussed possible applications of geocoding for understanding health disparities—e.g., in access to health care—and for linking health care quality and specific health outcomes. The group briefly discussed possible applications to understanding the homeless population.

Dr. Melnick explained that they are trying to cover resources that are not ordinarily thought of as public health resources, and to tie the Department’s work to that of other agencies that also collect information. Dr. Lumpkin noted the utility of GIS for looking at disease outbreaks.

Reports from Subcommittees and Workgroups:

• Subcommittee on Privacy and Confidentiality—Mr. Rothstein

Mr. Rothstein acknowledged Mr. Houston’s work on the letter on medical devices. Mr. Houston described the substantive changes in the revised letter. Following the addition of an explanatory sentence, the Committee passed a motion approving the letter, as revised.

Mr. Rothstein reviewed the Subcommittee’s hearing topics for the coming year:

• (Fall): several HIPAA concerns
• Accurately linking patients to their information (joint hearing with Subcommittee on Standards and Security)
• Personal health records and privacy issues (also with S&S)

• Subcommittee on Standards and Security—Mr. Reynolds

Mr. Reynolds described the changes made to the letter on e-prescribing discussed the previous day. Following one small amendment, the Committee approved the letter as revised.

Mr. Reynolds reviewed the Subcommittee’s forthcoming priorities:

• Hearing April 6-7 on HIPAA ROI
• HIPAA: continual follow-up on e-prescribing
• Joint hearings with Subcommittee on Privacy and Confidentiality
• Federal Health Architecture
• SDOs and how they work together
• Decision-support terminology, EHR, DSTU and CCIT, interoperability standards

Mr. Reynolds thanked Maria Friedman and Margret Amatayakul for their hard work and many contributions to the Subcommittee’s productivity.

• Subcommittee on Populations—Dr. Steinwachs

Dr. Steinwachs said that in the near term, the Subcommittee would focus on completing its report on race and ethnicity data. It discussed the importance of looking for targets of opportunity and will begin a discussion about the future work plan. There is interest in the complementarity and overlap between population health and quality topics and the implications for the two NCVHS groups. Other items that arose included data access issues and possibilities for using the Medicare D enrollment process to enhance information on race, ethnicity and language. The group discussed the time pressures that limit the chances of achieving anything on the last item, but Ms. Berek offered to help on this. The Subcommittee will try to have a proposal to present at the June meeting.

• Workgroup on Quality—Mr. Hungate

The Workgroup will hold a planning retreat on June 2-3 in Washington to lay the groundwork for revising its charge and work plan. The Workgroup also plans to summarize the useful hearings it held in 2004 on the first eight candidate recommendations.

• NHII Workgroup—Dr. Cohn

The Workgroup will hold a hearing on PHRs on April 26-27. In addition, it hopes to arrange a briefing on the Federal Health Architecture, probably for the full Committee.

• Executive Subcommittee —Dr. Cohn

The Subcommittee plans to hold two full-day meetings in the summer, to align all sub-group work plans, goals, and agendas.

Future Agendas for NCVHS Meetings

The following agenda items for discussed for future NCVHS meeting.

June 29-30:

• Populations report (Action)
• NCVHS 2003-2004 Report (Action)
• Letter on e-prescribing (Action)
• Status of RFI responses
• Briefing on the FHA
• Standards discussions — Certifying Commission on HIT
• Review draft of HIPAA report
• Conversation with Dr. Sondik (or in September)
• AHRQ Quality and Disparities Reports (or in September)
• Functional status update and the business case—including CMS work on health of seniors (Mr. Hungate) (or in September)

September 8-9:

• Letter from Subcommittee on Privacy and Confidentiality (Action)
• HIPAA Report (Action)

Finally, after thanking the staff for their support, Dr. Cohn adjourned the meeting.

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