Department of Health and Human Services


November 4-5, 2004

Hubert H. Humphrey Building
Washington, D.C.

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on November 4-5, 2004 in Washington, D.C. The meeting was open to the public. Present:

Committee members

  • John R. Lumpkin, M.D., M.P.H., Chair
  • Jeffrey Blair, M.B.A.
  • Justine M.Carr, M.D.
  • Simon P. Cohn, M.D., M.P.H., FACP
  • 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.
  • Vickie Mays, Ph.D.
  • Harry Reynolds
  • Mark A. Rothstein, J.D.
  • Donald M. Steinwachs, Ph.D.
  • Kevin C. Vigilante, M.D., M.P.H.
  • Judith Warren, Ph.D, RN


  • Peggy B. Handrich
  • C. Eugene Steuerle, Ph.D.

Staff and liaisons

  • Marjorie Greenberg, NCHS/CDC, Executive Secretary
  • James Scanlon, ASPE, Executive Staff Director
  • J. Michael Fitzmaurice, Ph.D., AHRQ liaison
  • Judith Berek, CMS liaison
  • Jack Anderson, acting NCHS liaison
  • Steve Steindel, Ph.D., CDC liaison
  • Aldonna Robbins, NCHS Board of Scientific Advisors liaison


  • Jackie Adler, NCHS
  • Gracie White, NCHS
  • Debbie Jackson, NCHS
  • Carol Bickford, ANA
  • Alicia Bradford, CMS
  • Arthur Ciarkowski, FDA
  • Cheryl Ford, CMS
  • Linda Fischetti, VHA
  • Maria Freedman, CMS
  • Suzie Bebee, ASPE
  • Patricia Watts, VHA
  • Roy Buscewitz, NACDS
  • Lori Davis, CMS
  • Henry Heffernan
  • Jason DuBois, ACLA
  • Laura Vartain, Wexler & Walker
  • Nancy Sonnenfield, RTI
  • Marilyn Luke, AHIP
  • Bill Alfano, BlueCross BlueShield
  • Norma Kim, RTI
  • Michelle Lim, GW Univ.
  • Stan Edinger, AHRQ
  • Edna Paisano, IHS
  • Roy Sewall, Sewall, Inc.
  • John Loft, RTI
  • Robert Burns, ADA
  • Mariann Yeager, Emerson Strategic Group
  • Deeana Jang, OCR
  • Ann Suraprvik, OCR
  • Dan Rode, AHIMA
  • Chuck Nelson, U.S. Census Bureau
  • Jonathan Teich, Harvard Univ.
  • Sharon Canner, CHI
  • Michael DeCarlo, BlueCross BlueShield
  • Philip Rothermich, Express Scripts
  • Kathryn Serkes, Assn. of Amer. Physicians & Surgeons
  • Catherine Lorraine, FDA
  • Stacey Malkin, Capitol Assoc.



  1. On the occasion of Jackie Adler’s retirement from NCHS and her last meeting with NCVHS after nearly twenty years, the Committee approved a motion to prepare a letter thanking her for her long and outstanding service to the Committee.
  2. Mr. Hungate presented a draft letter on a proposed secondary diagnosis indicator for hospital discharge data, resulting from three hearings. Committee members proposed a few modifications, and the letter was revised during the break-out session and approved as revised on the following day.
  3. The Committee approved sending a letter on the National Children’s Study, with minor editing, to Dr. Alexander of NICHD.

Update from HHS

  • Data Council: Jim Scanlon
  • Data Standards Update: Karen Trudel
  • Privacy Rule Compliance Update: Sue McAndrew

Mr. Scanlon described work on forthcoming and pending budgets, new assessments of survey data on prescribing and health insurance, and the geocoding project. Ms. Trudel reviewed impending implementation and compliance dates; talked about regulations in process, including Medicare compliance rates for claims; and reported about complaints, e-prescribing and CHI. Ms. McAndrew reported on the volume of privacy complaints and their disposition and on continuing outreach and education efforts. The Committee renewed its request for statistics to inform future advising and hearings.

Current Initiatives in National Health Information Technology: Dr. Brailer

Dr. Brailer’s briefing covered ONCHIT’s activities in these areas:

  • informing and protecting small clinician offices’ purchasing decisions
  • preliminary work on RHIOs, including release of an RFI
  • evaluating mechanisms for personal health records
  • collaborative studies on population health topics
  • work on the Federal Health Architecture

In response to a question, he discussed ONCHIT’s ongoing effort to build understanding about the need for additional funding for its agenda, which is “about the fundamental function of the health care industry.” The group discussed the need for further studies to establish the economic and social value propositions.

NCHS Board of Scientific Counselors Update: Dr. Robbins and Dr. Mays

These reports focused on the BSC’s plans to help NCHS in the areas of the CDC reorganization, an associated program review, and the Department’s evolving work on health information technology. Plans are afoot for joint work with NCVHS. The NCVHS report on a vision for 21st century health statistics has emerged as a useful framework.

Populations Subcommittee Report: Dr. Mays

Dr. Mays presented the proposed structure for a forthcoming report from the Populations Subcommittee, which is scheduled for presentation at the March 2005 NCVHS meeting. It will stress the importance of improving the collection of data on race and ethnicity. Committee members offered a number of suggestions on the content and tone of the report and asked that the recommendations be prioritized and circulated well in advance of the March meeting. Ms. Greenberg asked for a response from the Data Council to the August Commentary and recommendations (related to the forthcoming report) prior to completion of the full report, if possible.

The American Community Survey: Chuck Nelson, U.S. Census Bureau

The American Community Survey (ACS), the Census Bureau’s major new data gathering effort, is a large, continuous demographic survey that by 2010 will replace the Census long form. Making survey operations continuous rather than decennial and having experienced survey staff permanently in place will be more efficient and produce better data. The full survey is scheduled to start in 2005, including the entire U.S. household population, with first data products due the summer of 2006. The questions were developed based on requests from all federal agencies. Every question had to be rigorously justified because the survey is mandatory. The ACS is a mail-out survey, with phone and ultimately home-visit follow-ups. The Census Bureau has received support in FY04 and enough money to hire and train interviewers. Things are more up in the air for FY05.

In the discussion period, NCVHS members raised questions about adequate publicity for the ACS and its potential uses to produce useful information on health disparities and functional status.

Quality Workgroup Letter on Diagnosis Indicator—Mr. Hungate

Mr. Hungate presented a draft letter that resulted from three Quality Workgroup hearings conducted jointly with the Subcommittee on Standards and Security. (See Actions, above.) The group also discussed issues related to alignment of the UB-04, ICD-10 and HIPAA requirements as well as the general prospects for moving forward on content issues.

The NIH Roadmap for Medical Research—Lawrence Friedman

The Roadmap project started 2½ years ago, motivated by a desire to position NIH to better address evolving public health challenges. NIH seeks to accelerate the path of discoveries and more rapidly translate discoveries into patient care (“bedside”) and public health. Three general themes emerged from consultations with stakeholders: 1) new pathways to discovery, 2) research teams of the future, and 3) re-engineering the clinical research enterprise. Dr. Friedman described NIH activities in each of these areas. He focused primarily on the third, in which the overall aims are to promote better integration and communication within clinical research networks, to support translational research, and to encourage the development of technologies to improve assessment. The anticipated cost of this effort is just under 1 percent of the total $30 billion/year NIH budget, starting at $130 million in FY04 and growing to $507 million in FY09. The money comes from both central and individual institute sources.

In the discussion period, Committee members raised questions about facilitating workable delivery models for translating research into public and community health applications, allaying researchers’ and the public’s concerns about privacy and research, budget coordination, and movement toward standards.

Clinical Trial Research Agenda—Dr. Friedman

Dr. Friedman briefly described the criteria, funding structure and review process for NIH research support, as well as the function and purpose of research networks. Committee members and staff talked with him about NIH plans for achieving broader applicability of quality standards and better understanding of effect across the population; the complementarity of clinical trials, observational studies and medical records; questions about multiple trials and increasing the number of study subjects; variations in risk and outcomes among subpopulations; intergovernmental collaboration on standards implementation; making surgical therapies more evidence-based; and the future of collaborative research funding.

NCVHS 2003-2004 Annual Report; Research Agenda Ideas

The group briefly discussed and approved the proposed outline for the “annual” NCVHS report covering 2003 and 2004. They then reviewed documents related to recommendations for the HHS information policy research agenda, planned as a major topic in the 03-04 report. Following a detailed discussion of the purpose of this exercise and section of the report, the Committee agreed to catalog recommendations from the past 5 years in the forthcoming report and to use that as a foundation for any subsequent deliberations toward offering guidance to the Department on its information policy research agenda.


(Please see the brief summaries at the end of the next section.)



Call to Order, Welcome, Introductions, Review of Agenda

Dr. Cohn, serving as Acting Chair for Day 1, called the meeting to order and asked all present to introduce themselves.

Update from HHS

Data Council: Jim Scanlon

The government is still operating under a continuing resolution, so no new initiatives are allowed. Another CR or an appropriation is expected when Congress reconvenes. As discussed in September, the President’s FY05 budget has many positive features in terms of HIT and data policy. Plans are beginning for 2005 priorities, based on the assumption that the President’s budget will be approved more or less as proposed.  Mr. Scanlon discussed plans for health IT projects, strengthening the core health and vital statistics infrastructure, and methodological research. Early work is underway on the FY06 budget.

The Data Council began in September to look at current capacity for prescription drug data in surveys and administrative data systems, as part of activities related to the Medicare Modernization Act. The participants identified major gaps and will put together proposals for improving information in this area. The Data Council also convened HHS and other federal agencies to look at gaps and capacities in national health insurance data and data on the uninsured. A series of activities are planned to address gaps, develop a better framework for estimates, and do design modeling and analytic work. The investigation is looking at state and local as well as national levels. The major challenges are at the lower levels. The Data Council is also assessing the extent to which data standards, and especially terminology standards, are being used in HHS surveys and statistical systems.

In response to questions, Mr. Scanlon said the geocoding project is being conducted under Data Council auspices. It is nearly finished and was quite fruitful. NCVHS input into the uses of funding for future methodology projects is encouraged.

Mr. Scanlon referred a question requiring a “unified theory of national health information technology” to Dr. Brailer, who speaks later in the meeting.

Data Standards Update: Karen Trudel

Ms. Trudel reviewed impending implementation and compliance dates; talked about regulations in process, including Medicare compliance rates for claims; and gave a status report on complaints, e-prescribing and CHI.

Compliance and implementation dates:

  • Security: April 2005 for most plans and 2006 for small plans
  • National provider identifier: May 2007 for most plans, 2007 for small plans

Proposed rules:

  • Claims attachment standards: early 2005 publication
  • National health plan identifier: Spring 2005 publication
  • Modifications to transactions and code sets, second round: Summer 2004 publication

Medicare is receiving more than 98 percent of claims in totally HIPAA-compliant format, and there is great progress in related areas. CMS has received 247 complaints, 110 of which are open and under investigation. It is monitoring for corrective actions and finds that most people resolve their complaints before the government reaches the point of corrective action. The hotline currently receives about 1200 calls a month, compared to 5,000 calls in August through October 2004 and 15,000 the year before.

Regarding electronic prescribing, CMS is pursuing a proposed rule to set foundation standards in keeping with NCVHS recommendations. It hopes to implement them by January 2006. CMS has a contract to gather information on the characteristics of current e-prescribing implementation.

Regarding CHI, CMS is working on implementing and maintaining the standards already adopted as well as developing new standards as needed,  and is coordinating activities with Federal Health Architecture.

Asked how private payors’ experience compares to Medicare, Mr. Reynolds said about 66 percent of the claims Blue Cross/Blue Shield receives are HIPAA-compliant, and there is an upward trend. Vendors are bringing large numbers of providers to the table. Dr. Fitzmaurice noted that providers find the remittance advice an unexpected benefit of HIPAA standards.

With regard to e-prescribing, Mr. Localio asked whether a list of all the drugs that can be prescribed will be available to researchers and others, and how such a list will be maintained. Dr. Cohn noted that NCVHS approved a letter in September expressing concern about the “state of disrepair” of NDC files. Dr. Fitzmaurice described several federal efforts in this general area under his and Mr. Scanlon’s direction, and said a lot of progress has been made. One product will be an ongoing electronic listing of all the products FDA approves. The information will be given to the National Library of Medicine.

Privacy Rule Compliance Update: Sue McAndrew

A total of 9,277 complaints have been received to date, with the closure rate holding steady at 60 percent. The nature of the complaints and the entities filing them are the same as in past reports. The volume of complaints is somewhat lower than a year ago. The closure rate is higher than in the past. Just over 1 percent of complaints have been referred to the Department of Justice (140 of more than 9,200).

OCR is continuing to work on materials for its Web site, and is developing research fact sheets and FAQs with NIH (expected later in November) as well as technical assistance materials for small providers. It has stepped up efforts to address the overlap between privacy and security in anticipation of the security rule coming on line. CMS will handle security complaints. OCR is also pushing through clearances on a set of enforcement rules for both CMS and OCR. It is also preparing for e-prescribing.

Asked about the prospects for detailed statistics, per previous NCVHS requests, Ms. McAndrew said OCR is trying to refine and correlate the statistics, as time allows. Results are not yet user friendly. Mr. Houston reiterated the Privacy Subcommittee’s interest in trends to help shape future hearings and advising.

Mr. Blair expressed frustration and concern about whether people at OCR have lost sight of “the basic goal” of protecting personal health information and building public trust, and wondered whether it has been achieved. He urged an attempt to discern public attitudes and understanding. Ms. McAndrew said OCR is putting out more user-friendly information for consumers but it has conducted no surveys of consumer attitudes.

Current Initiatives in National Health Information Technology: Dr. Brailer

After releasing the HHS Strategic Framework in July, Dr. Brailer’s Office of the National Coordinator of Health Information Technology (ONCHIT) organized along those strategic lines and began work on specific goals. In the area of informing clinical practice, ONCHIT has been concerned about small clinician offices’ purchasing decisions. It is developing product certification to provide a “minimum floor” for product features, as well as mechanisms to reduce the purchasing finance risks and implementation risks. The Certification Commission for Health Information Technology has been formed for this purpose, headed by Mark Leavitt. It has four work groups—Functionality, Interoperability, Security and Reliability, and Inspection Process—which will be populated through a public nomination process. In addition, the Physicians EHR Collaborative has been formed to develop purchasing risk reduction strategies, working with the National Purchasers’ Alliance.

The regional health information organizations (RHIOs) are central to interconnecting clinicians, which is goal two. AHRQ is funding contracts to develop several “proto-RHIOs.” The first step is identifying the criteria for establishing such organizations, what benefits they convey on participants, how they relate to antitrust and tax issues, and so on. ONCHIT hopes to have a blueprint in place in time for the next round of grants and contracts, which will be announced in March or April. There is a great deal of activity in the private sector around the RHIOs.

The National Health Information Network is what allows interoperability to occur, and an announcement (RFI) about this is imminent. The purpose of the RFI is to ask questions and garner information on technical needs and gaps and other issues (economic, cultural, legal, etc.) involved in developing tools for wide information sharing. The next step is understanding how the NHIN can be built, the role of government, and how it can become a public asset. Dr. Brailer encouraged NCVHS to get on the record once the RFI comes out.

For the personalizing care goal, ONCHIT is continuing to evaluate mechanisms for expanding and accelerating the release of personal health records to consumers. To date, ONCHIT is “more of an observer” of the activities of other entities in this area. Its concerns are that PHRs be interoperable and truly person-centric and that they meet a standard of being usable by consumers and can gain public trust. Privacy and confidentiality issues concern both public trust and technological issues around authentication and authorization. An internal working group is looking at these issues and looks forward to input from the NCVHS Subcommittee on Privacy and Confidentiality.

ONCHIT is also working to streamline quality metrics and is watching the emerging discussion in this area. In population health, it is developing white papers in collaboration with AHRQ, AMIA and HIMSS on a number of topics. Structured clinical decision support and the integration of knowledge bases with EHRs is critical to closing the adoption gap between science and practice, and work on these questions is under way. In addition, ONCHIT is working with NIH, NCI, FDA, CDC, the Department of Homeland Security and other agencies on various population health topics.

Turning to cross-cutting issues, Dr. Brailer highlighted efforts for federal alignment related to the Federal Health Architecture, CHI and eGov. All federal agencies have been asked to report on their plans to conform to the Strategic Framework, including an analysis of gaps, duplications and variances. This process should make it possible to operationalize the Framework into a budget instrument. ONCHIT is also moving forward with the Health Information Technology Leadership Panel, comprised of non- health care industry executives with experience in productivity improvements.

ONCHIT is also involved in 2006 budget analysis.


Dr. Cohn expressed the Committee’s congratulations for all the work and accomplishments represented in the foregoing briefing.

Mr. Rothstein affirmed that the Subcommittee on Privacy and Confidentiality is planning hearings this winter (February) on the fundamental issues of patient controlled limits on the contents of PHRs and clinicians’ need for longitudinal information on their patients. Dr. Brailer observed that relationship issues between doctor and patient are at the crux of these concerns.

Responding to a question about the adequacy of funding for his Office’s operations, Dr. Brailer said they are working to build understanding about the need for additional funding, given that the agenda is “about the fundamental function of the health care industry.” The underlying issue, he said, is how to achieve a social goal and put the U.S. in a position to save money. He expressed hope that the full funding requested by the President would be restored. Explaining more about the implementation strategy, he said they are looking at the economic basis for health information technology with respect to both the health services industry and internal federal spending. ONCHIT has developed 15 value propositions (value realizations that can offset investments) that are being validated first conceptually and then with whatever data are available. Some of these relate, for example, to the elimination of duplication. He added that this is the most time-consuming thing his office is involved in and also the least visible, at least initially.

Dr. Steinwachs noted the merits of establishing the potential value to patients and their clinicians of easily available longitudinal health information about themselves. Dr. Brailer agreed that there are a wide range of economic and “uneconomic” benefits to be studied. He referenced Blackford Middleton’s group’s research on socioeconomic benefit. There is not yet a body of evidence available to inform policy, but there are “little dots of studies,” and more is needed. The AHRQ studies will expand the body of evidence.

Dr. Mays and Dr. Brailer discussed the handling of conditions that are difficult to quantify because people prefer to conceal information about them, e.g., mental health and substance abuse conditions and HIV. These issues require a separate conceptualization and policy.

In response to a question from Mr. Blair about how the various research initiatives fit together into RHIOs and NHIT, Dr. Brailer said that while the criteria for RHIOs will be informed by that work, the question of “the receptor site” in terms of the broad IT policy framework still needs to be worked out.

NCHS Board of Scientific Counselors Update: Dr. Robbins and Dr. Mays

The BSC has begun its second year by adding five new members. It is still largely in an organizational mode but is making progress. It has focused on the CDC reorganization and on how the BSC could help NCHS, and plans to help structure and participate in a peer review process mandated by CDC for all its agencies. The BSC had concerns similar to those of NCVHS with respect to where NCHS fits in the new CDC organizational chart. It has invited Dr. Gerberding to its January 2005 meeting to discuss the CDC reorganization and its effect on NCHS’s ability to function.

Dr. Mays, the NCVHS liaison to the BSC, has conveyed the NCVHS proposal to conduct joint activities with the two organizations and their executive committees; these plans will be discussed further. Dr. Robbins has met with the Subcommittee on Populations, and said she found the NCVHS vision for 21st century health statistics useful as a framework for the BSC’s work. Dr. Mays noted that monitoring the impact of the report on 21st century health statistics is a responsibility of the Subcommittee on Populations. It will look at how to bring that to bear on the forthcoming major evaluation of NCHS, and this will be a joint focus of the two bodies. The Committee’s forthcoming work on recommendations for the HHS health information research agenda (see below) also may yield directions for NCHS.

Asked about the program review, Dr. Robbins said its major focus will be “what is,” but there will also be attention to where the Center goes from here. Dr. Mays said the review will assess not only general directions but also whether the Center has the personnel and other resources to do what it wants to do. Another dimension, said Dr. Robbins, will be determining the implications of the Department’s information technology initiatives for NCHS work.

As background, Mr. Anderson explained that Dr. Gerberding initially instituted peer review processes for CDC grant programs and then for ongoing intramural programs. Dr. Sondik then asked to use the peer review process or a variant to help NCHS look at where it should be going. As for the reorganization, the idea behind the coordinating centers was to create more synergy among the various centers. The process is still underway, so the potential benefits have not yet been realized.

Populations Subcommittee Report: Dr. Mays

Dr. Mays presented a document summarizing the proposed structure for a forthcoming report from the Populations Subcommittee report. The Subcommittee expects to present a draft for approval at the March NCVHS meeting. She introduced writer Ann Rogers, who is working on the report with the Subcommittee.

The report will stress the importance of improving the collection of data on race and ethnicity so that health programs can target those with particular risk and need in order to improve their health. Currently, the lack of subpopulation data is a major impediment to the adequacy of the data. The increasing diversity within racial and ethnic groups and the importance of factors such as income contribute to the complexity. One stimulus for the report is the 1997 OMB guidance requiring changes in the categories for racial and ethnic data collection starting in January 2003. The report will examine the nature and limitations of national health data on racial and ethnic subpopulations as currently collected and used, and recommend strategies and actions for federal agencies to remedy these problems and fill the gaps. It will focus primarily on national surveys, but also address administrative data and contextual data. The major information sources for the report include past NCVHS recommendations and reports as well as IOM reports. Dr. Mays said a review of past NCVHS recommendations in these areas revealed that few have been acted upon, perhaps in part because of the magnitude of the recommendations and the lack of affordable, actionable strategies. Also, some recommendations need to be aimed at stakeholders outside federal government.

Dr. Mays then invited comments from the Committee, leading to a lengthy discussion with the group about various sections of the report. The points made include the following:

  • Administrative data are needed to augment the findings from less timely surveys.
  • The report introduction should explain both why race-specific data are important and the fact that “race” is only a social and not a biological construct.
  • The Subcommittee will encourage guidance from the Department to help people figure out how to capture good quality data.
  • Data collection burden issues affect not just states but everyone whose main job is not data collection, including medical providers and health plans. A corollary of burden issues is accuracy issues.
  • The group discussed the achievability of the objectives, what degree of accuracy can be expected given the complexities, and what realistic goals would look like — in the words of one member, “the best we can strive for.” Dr. Mays stressed the importance of training and guidance, and said the goals were for consistent, reliable and accurate data. She noted the differences in quality between private sector data and the data in national population surveys.
  • Although the report will discuss the many and complex challenges of collecting and using race and ethnicity data, members urged the Subcommittee to also present “success stories” showing cases in which such data were collected and used in health interventions. This will help to create a sense of hope, align incentives, and stimulate buy-in.

Finally, Dr. Mays briefly reviewed the areas in which recommendations would be made. They are consistent with the overarching recommendations and strategies presented in the related Commentary released by the Committee in August 2004. The Subcommittee was encouraged to find ways to begin to review specific recommendations prior to the March meeting, and to either keep the number small or prioritize them. Ms. Greenberg asked for a response from the Data Council to the August Commentary and recommendations prior to completion of the full report, if possible.

Recognition of Jackie Adler

On the occasion of Jackie Adler’s retirement from NCHS and her last meeting with NCVHS after nearly twenty years, the Committee approved a motion to prepare a letter thanking her for her long and outstanding service to the Committee. The Committee will hold a dinner in her honor following this meeting.

The American Community Survey: Chuck Nelson, U.S. Census Bureau

The American Community Survey (ACS) is the Census Bureau’s major new data gathering effort. It is a large, continuous demographic survey (3 million households a year) and by 2010 will replace the Census long form. It will produce information similar to that in the long form for every area covered by the Census, down to the tract or block group level, updated annually or for small places using multi-year averages. Making survey operations continuous rather than decennial and having experienced survey staff permanently in place will be more efficient and produce better data.

The Census Bureau has been testing the ACS since 1996 and has conducted the survey in a large national sample (800,000 households) since 2000. The full survey will start in 2005, including the entire U.S. household population, assuming it receives funding. The first data products are due the summer of 2006, with more data released every year thereafter. Communities of more than 65,000 people will receive annual estimates; smaller ones will receive 3-5 year averages. The 2005 survey will cover household residents only, and will be conducted in Spanish and English initially, with more languages being considered for the future. Content covers education, migration status, disability status, employment and income status, housing characteristics, and more. The questions were developed based on requests from all federal agencies. Every question had to be rigorously justified because the survey is mandatory.

Turning to budget issues, Mr. Nelson said the Census Bureau has pointed out that the ACS will save the country money because it is more efficient than the old way, and it has received support in FY04 and enough money to hire and train interviewers. Things are more up in the air for FY05, making this “a make-or-break year for the ACS.” The Director has threatened to shut down the ACS and plan a long-form census if funding is not received. The data will be harmed if Congress waits too long to decide.

The ACS is a mail-out survey. In 2004, the mail-back response rate was around 50 percent. Non-respondents are called and interviewed using a computer-assisted questionnaire; if that doesn’t work, a sample of remaining non-respondents is interviewed in person. Dr. Mays noted the targeted advertising campaigns around Census 2000 and asked about the level of publicity planned for the ACS. She also asked if the differences between respondants and nonrespondants has been analyzed, saying she had heard that some groups are concerned about the mandatory nature of the ACS. Mr. Nelson said Congress mandated a study of the voluntary-versus-mandatory question and concluded that the former would be prohibitively expensive because of resulting differences in response rates. He said they planned to publicize the survey and assure people their answers will be confidential and not used against them; but the campaign will not be at the level done for the 2000 Census. Dr. Mays observed that the Census Bureau was walking away from a proven method that increased participation.

Mr. Nelson explained the different approaches to data necessitated by the fact that the ACS is a rolling survey. Using the data will require adjustments in thinking on the part of agencies; local officials are among those most excited about the ACS because it will track annual changes in their communities.


Dr. Cohn noted the ongoing “angst” about issues of race and ethnicity data and asked if the ACS would provide an alternative to administrative data in getting reliable data to shed light on health care disparities. Mr. Nelson said that indeed, ACS data could help produce profiles of areas and in combination with other information could produce a better look at health care disparities.

Dr. Mays hailed the fact that “these population discussions are being spread all over.” She noted that “major firewalls” have to be present between different data sources. Noting the possibility of linking MEPS or other NCHS data to ACS data, she asked if NCVHS or HHS could request a particular question to produce needed data through the ACS. Mr. Nelson said agencies have successfully provided rationales for asking particular questions—for example, income data. A local area data need must be demonstrated for ACS questions, since national surveys can meet other needs. The ACS is recognized as “a great screening survey for a follow-up survey.” On data linkage, he noted Census shares data with some agencies, such as SSA, but health data are especially sensitive.

Mr. Hungate called attention to the questions about disability status, and Mr. Nelson said there is discussion of modifying them, led by Jennifer Madans of NCHS. Mr. Hungate noted the potential benefits of meshing ACS data on functional status and disability with ICF coding. Ms. Greenberg said Dr. Madans is leading an international effort to develop a small set of questions on disability that can be asked on any census in the world, with the ICF as the framework. She noted the synergy between the two activities and suggested that Dr. Madans brief the full Committee, Quality Workgroup or Subcommittee on Populations.

In response to other questions, Mr. Nelson said Census will be able to provide the same information in reports, using ACS data that it has in the past. The ACS will enhance the ways in which NCHS depends on Census workforce and sampling frames.

Quality Workgroup Letter on Diagnosis Indicator—Mr. Hungate

Mr. Hungate explained that this letter recommending a secondary diagnosis indicator for hospital discharge data is the outcome of three Quality Workgroup hearings conducted jointly with the Subcommittee on Standards and Security. Its subject is one of a number of candidate recommendations identified by the Workgroup and approved by the Committee in a May 2004 report. Mr. Hungate read the letter aloud, pausing periodically for discussion. A number of editorial suggestions were proposed. The Workgroup will present a revised version of the letter on day two of this meeting.

The group briefly discussed issues related to alignment of the UB-04, ICD-10 and HIPAA requirements. Mr. Hungate reported that the UB-04 may be held up by the implementation of ICD-10-CM, with no clear statement from the Department about this.  Dr. Cohn noted the possible need for a clarification of understanding between the NUBC and the Quality Workgroup on these matters. Ms. Greenberg noted that the NUBC is meeting in mid-November and will discuss related matters.

Reflecting on the hearings, Mr. Hungate said they revealed considerable frustration about the ability to move the information system forward in terms of content for quality assessment. He added that the prospects for any action on the other five candidate recommendations seem very dim. Dr. Cohn observed that there are still questions about the business case and value added for several of the recommendations.

Focusing on the bright side, Ms. Greenberg pointed out that the UB-04 is likely to be implemented in the next few years, facilitating several of the Committee’s candidate recommendations. In addition, a cost-benefit study on adding selected clinical information to administrative standards is planned by AHRQ, and this study will inform the business case.

The Committee then recessed into subcommittees and workgroup sessions, to reconvene the following day.


The second day’s session was chaired by Dr. Lumpkin.

The NIH Roadmap for Medical Research—Lawrence Friedman

The Roadmap project started 2½ years ago, motivated by a desire to position NIH to better address evolving public health challenges such as the trend toward chronic diseases and co-existing conditions, national and worldwide health disparities, emerging and re-emerging diseases, and the prevalence of behavioral (life-style) diseases. NIH seeks to accelerate the path of discoveries and more rapidly translate discoveries into patient care (“bedside”) and public health. The Roadmap was developed through extensive consultations that looked at today’s scientific challenges, the roadblocks to progress, what is needed to overcome them, and what actions are needed from NIH as a whole rather than from its 27 component institutes and entities. The Roadmap is a framework of priorities for optimizing  NIH’s research activities, a set of initiatives aimed at extending the quality of healthy life, and a means to more efficient and productive research.

Three general themes emerged from the discussions: 1) new pathways to discovery, 2) research teams of the future, and 3) re-engineering the clinical research enterprise. In the first area, the initiatives address technologies and approaches necessary to meet current research needs—for example, developing molecular libraries and establishing Centers for Biomedical Computing. In the second area,  NIH will encourage multi- and interdisciplinary teams and support larger, coordinated resource sharing teams. Investigator-initiated activities will be preserved but with encouragement to “take creative, unexplored avenues.” To that end, the NIH Director’s Pioneer Award has been established.

Turning to the third area, Dr. Friedman said the overall aims of the re-engineering are to promote better integration and communication within clinical research networks, to support translational research, and to encourage the development of technologies to improve assessment. Related initiatives are aimed at harmonizing regulatory processes and enhancing training. Clinical research networks have existed in some institutes for well over a decade; the problem is that “many of them don’t talk to each other very well, if at all.” NIH aims to get them to share resources, data, materials, and technologies and to link existing networks of studies so that trials and other clinical studies can be conducted more efficiently and get into the public more quickly. It has funded 12 groups of clinical networks to do pilot work on such sharing. This involves overcoming barriers that include patient privacy constraints, differing technologies, and the culture of the scientific community.

NIH is also trying to enhance translational research (defined here as “research at the bench-bedside interface”) by equipping investigators with the resources, mechanisms, regulatory environment, and so on that they need in order to work at this interface. One initiative is aimed at coming up with standard ways of measuring quality of life for use across disciplines. Others are clinical workforce training and “harmonization,” the latter aimed at overcoming the disparate agency requirements and oversight issues for research grantees. NIH has created an office within its Office of Scientific Policy to work toward harmonization with other government agencies and other groups and develop clear, effective and coordinated policies and regulations. Priority areas include adverse event reporting, privacy, and IRB procedures.

The anticipated cost of this effort is just under 1 percent of the total $30 billion/year NIH budget, starting at $130 million in FY04 and growing to $507 million in FY09. The money is coming from both central and individual institute sources. Dr. Friedman predicted that the Roadmap will benefit multiple institutes, in contrast with past practices which confined learnings to single institutes. NIH plans to communicate about and evaluate the Roadmap over time and change it as needed, in consultation with all stakeholders.


Dr. Steinwachs noted the contradiction between the emerging dominance of chronic illness and the Roadmap’s use of the terminology “bedside,” which implies acute care. He commented on the challenges of translating research into public and community health applications, and asked how NIH will help facilitate workable delivery models. Dr. Friedman said NIH has not traditionally seen that as its mission, but this is changing for many institutes which are planning to fund this type of translational research. This includes both NCI and his institute, NHLBI, which has just formed a new branch for that purpose.

Asked about budget coordination, he said all the Roadmap activities are directed or managed through single institutes, with the money following the responsibility, but all “done under Roadmap imprimatur.” Asked whether investigator-initiated research can be expected to yield the kinds of multidisciplinary or “big science” approaches envisioned in the Roadmap, he said he anticipated that the major changes will be a broader mindset on the part of investigators and an infrastructure to assist them in doing new kinds of research.

Dr. Mays observed that IRBs still tend to go their own way, whatever the consensus at the NIH level, and she asked if one product of the Roadmap might be resources for IRBs to use. Dr. Friedman said this was planned as part of the harmonization activity.

Dr. Harding noted that NCVHS shares NIH’s concern about the “confusion regarding applicability of privacy requirements and HIPAA to clinical research.” He asked how NIH is dealing with that confusion, and Dr. Friedman said it provides information and education materials to researchers. Mr. Hungate noted the existence of “a public trust issue” related to the electronic disclosure of patient information, relating to the issues NIH is addressing. Dr. Friedman said an explicit Public Trust activity is also part of the Roadmap.

On the effort to link research networks and promote cooperative research and sharing, Dr. Lumpkin asked what kind of standards NIH is considering. Dr. Friedman said the initial result of the 12 pilot projects is likely to be “12 best practices”; no standards implementation is anticipated in the short run beyond consistency with Departmental procedure. Asked whether NIH had considered using the ICF for patient-reported outcomes, he said all pilot projects have been encouraged to be “as consistent as possible with national and international standards.” Ms. Greenberg suggested that the Quality Workgroup be briefed on these projects. Mr. Scanlon said the NLM people heading the clinical trials research data infrastructure are participating directly in CHI data standards efforts. The idea is to view clinical trial information infrastructure activities as part of the overall NHII.

Clinical Trial Research Agenda—Dr. Friedman

In this briefing, Dr. Friedman said the NHLBI perspective would predominate. About 70 percent of clinical trials are funded by industry, under the direction of the FDA, “to prove that something is worthwhile before it’s allowed to get out there.” Government-funded research focuses on areas that industry does not address, such as life style change trials, off-patent drugs, disease-focused strategies that combine or alternate drug therapies (e.g., for hypertension), surgery studies or studies of rare conditions.

The criteria for prioritizing clinical trial support include improving public health, enhancing scientific understanding, translation of findings into practice, and whether another entity (e.g., industry) should fund the research. There are also a host of ethical issues. All studies undergo scientific and ethnical review and are monitored for safety and integrity.

Dr. Friedman described the basic NIH funding structure, which primarily revolves around investigator-initiated R01s in single or multiple centers. The Institute also initiates trials. The research environments include specialized clinical research centers and research networks. He enumerated the Institute’s criteria for deciding whether to put an investigator-initiated proposal through the peer review process. Ideas for studies come from workshops, working groups, prior studies,  and other sources. The review process starts internally, followed by review by a Board of Extramural Advisors, the Advisory Council and finally the Institute Director. Institutes also do intramural research—primarily small, early-phase clinical trials with separate review and decision-making processes.

Research networks are flexible mechanisms that include multiple clinical sites, a data coordinating center, and an agreement to collaborate on multiple protocols over multiple years. They exist to fill a gap in research activity in a particular discipline. The first one was formed around asthma. The networks make it possible to address management questions in clinical topics and to rapidly implement clinical trials. They are efficient because they share resources and allow recruitment of adequate patient numbers, and they can generate rapid discoveries and future protocols. The networks address a range of studies in the categories of safety/efficacy, novel therapies, and special populations. The ultimate goal is to improve public health.


To a question, Dr. Friedman said there are hundreds of phase 1 and 2 trials going on at NIH and several hundred phase 3 and 4 trials; in each case, about half are at NCI. NHLBI has 70-80 late-phase trials at any one time.

Dr. Steinwachs observed that while most Americans with chronic disease have more than one, most clinical trials focus on a single disease, making it more difficult to assess quality and the efficacy and effectiveness of treatment. This is further complicated by the variations among sub-populations. He asked how NIH plans to help achieve broader applicability of quality standards and better understanding of effect across the population. Dr. Friedman said a goal of the NIH Roadmap is to facilitate this broader view, investigation and knowledge-sharing across domains “to answer more real-world questions.”

To another question, Dr. Friedman commented on several ways in which routine medical records could be used in research. Mr. Scanlon observed that given the existence of co-morbidities and the extreme cost of pure clinical trials, some people think the future of research, at least to evaluate procedures and medications, lies in using medical records and insurance data. Dr. Friedman agreed and said clinical trials, observational studies and medical records should be regarded as complementary.

Dr. Lengerich noted that multiple observational trials or clinical trials on the same subject seem to have similar results, raising the question of whether multiple studies are needed. He asked about the potential for getting a larger percentage of cancer patients into trials. On the first question, Dr. Friedman observed that the problem is that sometimes different trials do not agree and it is impossible to identify those in advance. On the second, he said NHLBI is doing no better than NCI in the percent of people coming into studies; he has no solution in mind, but all the institutes are looking at the question.

Mr. Localio asked if institutes ever look across trials to see whether certain subgroups or subclasses do better than others. Dr. Friedman said it was important to look at these questions of varied risk and outcome, and this is commonly done; he also noted the difficulties of achieving consistent and reliable findings.

Dr. Steindel observed that both CDC and the profession as a whole encounter problems with implementing standards once they are selected; implementation is an area where different government entities need to collaborate. In response to a follow-up question, Dr. Friedman said there is an effort at NIH to pick up on NCI’s work on caBIG and “come into a common environment.”

Asked about steps to address the inherent challenges of surgical research to make surgical therapies more evidence-based, Dr. Friedman said that while the Roadmap hasn’t addressed this, it is recognized as a major issue. He said he would try to find a way to bring it into the Roadmap process.

Asked about the future of collaborative research funding (e.g., with CMS), he said this was a promising activity that among other things can inform reimbursement policy.

NCVHS 2003-2004 Annual Report; Research Agenda Ideas

The group briefly discussed and approved the proposed outline for the NCVHS report covering 2003 and 2004.

They then reviewed documents related to recommendations for the HHS information policy research agenda, planned as a major topic of the 03-04 report. The Executive Subcommittee first discussed this topic and had specific ideas at its August retreat. Dr. Lumpkin suggested that following further input from subcommittees and workgroups, the Executive Subcommittee create a structure for presenting the recommendations. Ms. Greenberg reminded the group that one impetus is the absence of a follow-up mechanism for research recommendations that are part of broader NCVHS recommendations to the Department. The idea is to pull together the recommendations made over the last 5 years.

Mr. Blair noted the distinction between the Committee’s recommending research per se (e.g., research on the impact of the HIPAA privacy rule) and its requesting research to gather findings needed to inform future NCVHS recommendations. Mr. Hungate observed that in some cases the Committee needs a response from the Department about the recommendation itself—for example, to the May 2004 recommendation that the Department conduct research on ICF. Dr. Mays said the Data Council is working on priorities for a research budget, and the Committee’s recommendations might provide guidance.

Mr. Rothstein requested a clarification of the objectives for this exercise with respect to the Annual Report. He and Mr. Scanlon cautioned against scope creep. Mr. Scanlon advised that an effort to develop a research agenda (as distinct from cataloging past research recommendations) should involve careful deliberation about priorities. Dr. Lumpkin suggested that the Committee catalog past recommendations in the forthcoming report and use that as a foundation for any subsequent deliberations toward offering guidance to the Department on its information policy research agenda. The group further agreed to consider developing a prioritized list of research recommendations sometime in the future, not related to the 03-04 report. Mr. Scanlon observed that this process needs to be done with an eye to the latest thinking in the Department about national health information networks and the strategic framework. Dr. Mays suggested including representatives from NIH and AHRQ, as well as other agency liaisons, in future discussions about research priorities.

Ms. Greenberg pointed out that that all inputs to the 03-04 annual report, including the review of past research recommendations, are due by February 1. The reasons for the effort include compiling all the recommendations in one place to give them visibility and to contribute to the broader discussion of research priorities for health information policy. Ms. Jackson said she would help coordinate schedules.


Quality Workgroup—Mr. Hungate

Mr. Hungate read the revised version of the letter discussed the following day, and the Committee approved it.

NHII Workgroup—Dr. Lumpkin

The Workgroup will hold hearings on the personal health record (PHR) on November 12 and January 5-6. Topics of interest to the Workgroup include interoperability and governance issues for regional health information organizations. The overarching question is how to add value to the process of the Office of the National Coordinator for Health Information Technology.

Ms. Williamson was asked to describe a new capability, tested at the previous day’s NHII Workgroup meeting, that allows remote audience members to access presenters’ materials (e.g., powerpoints) on the Web. This augments existing Webcasting and phone-in capabilities.

Mr. Scanlon called attention to two items due for release in the near future on which the Committee may want to comment: a request for information on the National Health Information Network, issued by ONCHIT, which will have a 60-day comment period (though the Committee is not limited to giving input during this period); and proposals for initial e-prescribing standards. The group discussed these possibilities. Mr. Scanlon advised the Committee to avoid using hearings to get input about RFIs and NPRMs during their comment periods, because this can cause confusion.

Subcommittee on Standards and Security—Mr. Blair

The Subcommittee is digesting a presentation on e-prescribing heard the previous day, and planning its December 8-10 meeting. Mr. Houston described plans for the Subcommittees on Privacy and Standards/Security to receive testimony on issues related to the HIPAA security rule and medical equipment.

Subcommittee on Privacy and Confidentiality—Mr. Rothstein

The Subcommittee is preparing for a wide-ranging period of hearings and work over the next several months. Mr. Rothstein briefly described the hearings planned through February. It is still deciding on its work products.

Subcommittee on Populations—Dr. Mays

In developing its forthcoming report, the Subcommittee plans to draft the strategy section first and circulate it to Committee members for comments. The Subcommittee’s ad hoc group on mental health statistics is moving forward and will be interacting with Dr. Manderscheid’s office on the development of Mental Health U.S. 2004. The draft of this report will be sent to the entire Committee. The Subcommittee is focusing on what mental health statistics should be collected on an ongoing basis and how HHS data in this area can be brought together. The Subcommittee also has been working with the Quality Workgroup and the Subcommittee on Privacy and Confidentiality on issues of common interest. In the latter area, as a first step, the Subcommittees plan to contract for a compilation of all policies, procedures and regulations governing the release and sharing of data. Dr. Lumpkin encouraged them to include cell size issues. Dr. Mays said the Subcommittee would also look at methodologies used with small cell sizes. The group discussed procedural matters and staffing for this effort.

The Subcommittee had an update from NICHD on the National Children’s Study on October 26, and drafted a letter to Dr. Alexander following the briefing. Dr. Mays read the draft letter aloud. The Committee approved sending the letter, following minor editing.

Quality Workgroup—Mr. Hungate

Mr. Hungate described the Workgroup’s joint work with the Subcommittee on Populations on race and ethnicity data. The next area it plans to address is functional status; and it hopes to hear back from the Data Council in March 2005 on the Committee’s recommendation about adoption of ICD-10-CM. Mr. Scanlon offered suggestions on source materials and people for the work on race and ethnicity data and described governmental efforts to create a systematic framework for the various proposals on standards and interoperability.


The Executive Subcommittee will hold a conference call in January to plan the March meeting. Ms. Greenberg thanked Ms. Jackson and Mr. Scanlon for putting together this meeting. She mentioned the following possibilities for forthcoming ones:

  • Board of Scientific Counselors briefing
  • Dr. Sondik’s annual update on NCHS
  • e-prescribing recommendations (March)
  • Privacy recommendations (March)
  • Populations report (March)
  • Annual report draft review (June)
  • Recommendations on geocoding?
  • Recommendations on functional status?

Finally, Ms. Greenberg expressed appreciation to Jackie Adler for her service to the Committee, and told her she would be missed. Dr. Lumpkin then adjourned the meeting.

I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.


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