Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

March 4-5, 2004

Washington , D.C.

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on March 4-5, 2004 at the Hubert H. Humphrey Building 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
  • Peggy B. Handrich
  • Richard K. Harding, M.D. (telephone)
  • 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. (telephone)
  • Donald M. Steinwachs, Ph.D.
  • C. Eugene Steuerle, Ph.D.
  • Kevin C. Vigilante, M.D., M.P.H.
  • Judith Warren, Ph.D, RN

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
  • Virginia Cain, NIH liaison
  • Ed Sondik, Ph.D., NCHS liaison
  • Steve Steindel, Ph.D., CDC liaison
  • Aldonna Robbins, NCHS Board of Scientific Counselors liaison

Others

  • Debbie Jackson, NCHS
  • Jackie Adler, NCHS
  • Frank Kyle, American Dental Assn.
  • Brenda Evelyn, FDA
  • Miryam Granthon, ODPHP
  • Colleen Ryan, Indian Health Service
  • Laura Varfain, Wexler & Walker
  • Stan Edinger, AHRQ
  • Sarah Wattenberg, SAMHSA
  • Dan Rode, AHIMA
  • Nancy Torrieri, Census Bureau liaison to Subcommittee on Populations
  • Gail Horlick, CDC (phone)
  • Carol Bickford, ANA
  • Arthur Ciarkowski, FDA
  • Vivian Auld, NLM
  • Linda Blankenbaker, NCHS
  • Barry Dickonson, VA/VHA
  • Lisa Turner, NACHRI
  • Winifred Carson-Smith, ANA
  • Evelyn Kappeler, OPHS
  • Meryl Bloomrosen, eHealth Initiative
  • Marilyn Zigmund Luke, AAHP-HIAA
  • Henk Lamberts, University of Amsterdam
  • Inge Okkes, University of Amsterdam
  • Lori Evans, eHealth Initiative

EXECUTIVE SUMMARY

ACTIONS

  1. The Committee approved a letter to the Secretary on claims attachment standards.
  2. The Committee approved a letter to the Secretary summarizing the findings of hearings on the effect of the privacy rule on public health; research; and health care providers, health plans and consumers.
  3. The Committee approved a motion that the revised Quality Workgroup report will be reviewed by the Executive Subcommittee, which it authorized to approve the report if it determines that the revisions are not substantive.
  4. The Committee passed a motion that the 6th Report to Congress on HIPAA will be revised per discussion at this meeting and sent to all Committee members for a comment period, after which the Executive Subcommittee is authorized to finalize the report and send it to Congress.

Claims Attachment Letter — Dr. Cohn

Dr. Cohn read aloud, and the Committee discussed, a letter to the Secretary on claims attachments. Suggested revisions were referred to the Subcommittee, which presented a revised version of the letter on day two of this meeting. The Committee approved the revised letter as read.

Privacy Letter — Mr. Houston

With Mr. Rothstein participating by telephone, Mr. Houston read aloud a letter drafted by the Subcommittee on Privacy and Confidentiality, summarizing the findings of November, 2003 hearings about the effect of the privacy rule on public health; research; and health care providers, health plans and consumers. Following discussion, the letter was referred to the Subcommittee for revision. The revised version was presented on day two of this meeting, discussed and revised further, and approved.

Panel Presentation on Population Health

1. Health Statistics for the 21st Century

—Dan Friedman, Ph.D., consultant (former chair, NCVHS Workgroup on Health Statistics for the 21st Century)

Dr. Friedman briefly described the joint NCVHS/NCHS report, “Shaping a Health Statistics Vision for the 21st Century,” noting that its definitions of health statistics and the health statistics enterprise and mission all focus on the influences and actions that affect population health. The report stresses the need for an overarching population health conceptual framework for health statistics, outlines such a framework, and enunciates ten principles for the health statistics enterprise.

Dr. Friedman described the extreme proliferation in most states of separate data sets, raising questions about a unifying conceptual framework, interoperability, and communication. He outlined three “relatively simple tactics” NCVHS could undertake to overcome these issues: learning what data we have and what we don’t have; increasing data set interoperability; and fostering collaboration. For the continuum involved in producing health statistics, he proposed the idea of a virtual network that would distribute functions and responsibilities to their most appropriate place, with a “nerve center” in the middle.

2. Population Health and Its Implications for Health Statistics

—Barbara Starfield, Ph.D., Johns Hopkins School of Public Health (former NCVHS member)

Dr. Starfield pointed out the major challenges facing the U.S. health system, including declining population health status and the poor quality of health services and health systems. After summarizing the differing perspectives and emphases of different branches of medicine regarding the determinants of health, she stressed the centrality of the population health perspective to the health systems view and the need to look at health disparities among population groups. The key question in public health is, “What characteristics are most salient in improving overall health and the distribution of health in populations, and what does evidence suggest should be priorities for intervention?”  She discussed the implications of this analysis for data and information systems. Among other things, she asserted population health measurement should at least use stratified analysis (levels of health within major subgroups) rather than statistical adjustment.

Dr. Starfield stressed that population health is not the sum of individual health, and averages conceal essential information about systematic differences in health and how they can be remedied. The population-level or public health view pays attention to average health (both occurrence and severity) as well as the distribution of health (equity). Looking only at the sum of individual health misses key information about co-morbidity and the effects of the non-random distribution of health associated with age, geography, and societal differences.

3. A Health Plan Perspective on the 21st Century Health Statistics Vision

—Carl Volpe, Ph.D., WellPoint

C alling WellPoint not only the second largest but “the most market-oriented health insurance company” in the country, Dr. Volpe noted the different missions of the population health endeavors and health plans; the latter make decisions based on the ability to provide an affordable quality health benefit in the marketplace. For example, he observed that because of the differences in mission and market competition, plans have a “strong bias against the use of our data for policy development.” After characterizing his company’s use of data, he identified the following areas of agreement with the health statistics enterprise: the value of data to measure and improve population health, the need for data standards, the need for strong but reasonable privacy and confidentiality standards, and the need to recognize the influence of certain disease states on population health. He noted the trends among health plans toward a multi-pronged emphasis on health improvement and physician quality improvement as well as appropriate drug usage and early epidemic detection plans. He described a project to pool plan data on antibiotic prescribing, done in cooperation with CDC, which resulted in information to physicians about their prescription patterns. WellPoint also did another project with CDC on early epidemic detection.

Dr. Volpe observed that health plans, although they are “playing at the margins” because of their differing missions, nevertheless “can contribute to the [public policy] effort.” He cited several areas for future collaboration, including standard quality outcome measures, standards for collecting race/ethnicity, SEP and primary language data, EMR standards, and expanding health improvement programs.

In the discussion period, Dr. Starfield commented with respect to the anticipated benefits of the EHR that the analytic context and the questions asked of the information would remain critical. Ms. Handrich pointed to the challenge of finding a convergence of interest between the public and private sectors that would enable the use of information for the benefit of both the private sector and the public at large. Dr. Sondik said the foregoing discussion offers “new thoughts on absolute fundamentals” and should be treated as a benchmark

Quality Report — Mr. Hungate

Members were asked to comment both on the draft Quality Workgroup report and on the process for moving it forward. Initial discussion focused on process and generated several suggestions. Eventually, the Committee agreed to reframe the report’s “high-level recommendations” as “candidate recommendations” that are intended to identify issues and collectively set the quality agenda for the entire committee and its subgroups. A brief discussion of content resulted in a few suggested edits. The Workgroup was charged with bringing back a revised report and proposed next steps for consideration on day two of this meeting.

The following day, the Committee agreed that given the relatively minor modifications expected to the report, it would be referred to the Executive Subcommittee for further action. They approved a motion authorizing the Executive Subcommittee to approve the report if it determines that the revisions are not substantive.

Status report, Subcommittee on Populations — Dr. Mays

Dr. Mays offered a few comments as background to the report on race and ethnicity data that will be submitted by the Subcommittee at the June meeting.

  • Update from the Department

  • Data Council — Jim Scanlon, ASPE

  • HIPAA Data Standards and CHI — Maria Friedman, CMS

  • HHS Implementation of HIPAA Privacy Rule Compliance—Susan McAndrew, OCR

Mr. Scanlon reported on these topics:

  • The reports of the National Academy of Sciences study of the adequacy of race and ethnicity data in public and private sector systems
  • The HHS Council on the Application of Health Information Technology
  • The final rule for bar-coding standards for human drugs and biological and blood products
  • The 2004 budget and the President’s 2005 draft budget
  • The Department’s responses to NCVHS recommendations

Dr. Lumpkin commented that the signs from Congress are that things do not look good for public health in the 2005 budget.

Ms. Friedman reported on these topics, among others:

  • The publication of the National Provider ID regulation in January
  • The fact that two-thirds of Medicare transactions are now HIPAA-compliant
  • The CMS announcement that the payment cycle for non-compliant claims to Medicare has been pushed back from 14 to 28 days, starting July 1, 2004.
  • Plans to put out the NPRM on the national health plan identifier this year

Ms. McAndrew reported that OCR had received 4,755 complaints as of the end of February 2004 and has closed 43 percent of the cases. Compliance dates are coming up: small health plans must be in compliance by April 15, 2004, and that is the end of the grace period for getting business associate contracts in place.

Committee members discussed their interest in seeing 1) statistics on the breakdown of complaints by ty pe of covered entity, including physician offices versus health plan, and by type of complaint, and 2) a qualitative cost-benefit assessment of the privacy regulation. The Subcommittee on Privacy and Confidentiality was asked to work with OCR on developing such a report.

IOM Report on Patient Safety — Philip Aspden, Ph.D., IOM

Patient Safety: Achieving a New Standard for Care was released in November 2003. Dr. Cohn, a member of the IOM committee that produced the report, introduced Dr. Aspen, who directed the study. One recommendation of the IOM’s Quality Chasm report was that higher quality care would require “redesigned systems of care, including the use of information technology to support clinical and administrative processes.” The new Committee was charged with producing a detailed plan to facilitate development of data standards applicable to patient safety, identify key standardization issues, and provide guidance to DHHS on a set of key capabilities for electronic health record (EHR) systems.

The IOM Committee revised the IOM definition of an adverse event to include omission as well as commission. It was also very interested in near misses. It has issued seven recommendations, the first of which calls for improved information systems in all care settings and calls on health care organizations to implement comprehensive patient safety systems that provide immediate access to patient information and decision-support tools and capture patient safety information as a byproduct of care. (Project webpage: http://www.iom.edu/project.asp?id=4629]

The Committee’s work on EHR followed from an “add-on charge” from DHHS that came midway in the process. The report on this subject is posted on the IOM Web site.

HL7 took this information as input, and its forthcoming functionality model standard will be for the most part compatible.

In general, the IOM Committee recommended a systems approach to patient safety, with information technology and thus clinical data standards playing pivotal roles. Its other recommendations on patient safety are in the following areas:

  • establishment of the NHII
  • the key role of federal leadership
  • a detailed work plan for standards development
  • comprehensive patient safety programs
  • a paradigm shift from a retrospective to a prospective approach to patient safety
  • an applied research agenda
  • reporting systems

(Please see the detailed summary for the remaining brief agenda items.)

DETAILED SUMMARY

—DAY ONE—

Call To Order, Welcome, Introductions, Review Of Agenda

Dr. Lumpkin called the meeting to order and asked all present to introduce themselves. Committee members stated any conflicts of interest or need for recusals. (Any that are relevant to this meeting are restated in the appropriate context.)

Claims Attachment Letter — Dr. Cohn

Dr. Cohn presented a letter on HIPAA standards for electronic claims attachments, drafted by the Subcommittee on Standards and Security as a result of December and March hearings. The SDOs have been working on such a standard, and the draft letter urges the Department to encourage and support several demonstration projects and pilots. He read the letter aloud and invited comments and edits. After a brief discussion, the letter was referred back to the Subcommittee, which will present a revised version on day two of this meeting.

Privacy Letter — Mr. Houston

With Mr. Rothstein participating by telephone, Mr. Houston read aloud a letter drafted by the Subcommittee on Privacy and Confidentiality, summarizing the findings of November, 2003 hearings about the effect of the privacy rule on public health; research; and health care providers, health plans and consumers. Members of the Committee and staff offered editorial suggestions and discussed a number of issues raised by the letter.

Several complex issues related to IRB roles and responsibilities emerged in the context of the research section, some of them beyond the scope of the letter. (The text of the discussion can be found in the meeting transcript on the NCVHS Web site, ncvhs.hhs.gov.)

Discussion of the final portion of this letter was deferred to the Subcommittee meeting preceding the full Committee meeting on the following day. The Subcommittee will bring the revised letter to the full Committee day two of this meeting.

Panel Presentation on Population Health:

Health Statistics for the 21st century

—Dan Friedman, Ph.D., consultant (former chair, NCVHS Workgroup on Health Statistics for the 21st Century)

Dr. Friedman acknowledged the strong support of Committee members and staff and of the National Center for Health Statistics in the production of the joint NCVHS/NCHS report, “Shaping a Health Statistics Vision for the 21st Century” (posted on the NCVHS Web site). He briefly described the report, noting that it defines health statistics for the first time in the public health literature, a definition that focuses on the influences and actions that affect population health. It also defines the health statistics enterprise and its mission, again focusing on population health.

The report stresses the need for an overarching population health conceptual framework for health statistics, to help maintain this focus on the population and the community rather than on more proximate influences on population health. It lays out a schematic of one such conceptual framework, outlining the influences on the population’s health. In addition, the report articulates ten guiding principles for the health statistics enterprise, starting with enterprise-wide planning and coordination and ending with continuous evaluation.

Turning to state health data, Dr. Friedman presented a picture of archetypical state data systems, showing the proliferation, in most states, of separate data sets. His “archetypical” list shows 152 data sets in 13 categories (cost reports, encounters, licensures, surveys, etc.). Collectively, they raise questions about whether there is a unifying conceptual framework; whether there is interoperability among the data sets; and whether there is communication among the data sets, the data providers, the data collectors and the data analysts.

He then outlined three “relatively simple tactics” the Committee could undertake  to overcome these issues:

  1. (conceptual): Learning what data we have and what we don’t have
  2. (methodological): Increasing data set interoperability
  3. (procedural): Fostering collaboration

Regarding the first tactic, he suggested the possibility of focusing on models of population health and using a population health model as a template for evaluating data holdings and identifying gaps. The Canadian Institute for Health Research is conducting a project of this kind. For the second tactic, he suggested facilitating linkage and intersectoral research through common identifiers, variable definitions, content, codes, and transaction standards.

Regarding the third tactic, he proposed the notion of a governance continuum for producing health data for policy purposes, extending from governmental through quasi-governmental to non-governmental organizations. No single correct organizational model exists, as it varies by locale, but it is time to start thinking about different frameworks. One possibility as a new point on the organizational governance continuum is a virtual network that would distribute functions and responsibilities in the health statistics enterprise to their most appropriate place. Such a network would require a nerve center in the middle to assess population health information needs, establish priorities, convene participants, coordinate planning, and facilitate sharing and linkage.

Population Health and Its Implications for Health Statistics

—Barbara Starfield, Ph.D., Johns Hopkins School of Public Health (former NCVHS member)

Dr. Starfield characterized several large challenges facing 21st century health systems. One is the poor and worsening position of U.S. population health indicators — the lowest of all industrialized countries for several indicators. Another is the poor quality of health services, with issues related to responsiveness to needs (as contrasted with demands), increasing co-morbidity, coordination of care, overuse, and safety. (She noted estimates that adverse effects and errors account for the third leading cause of death in the U.S.) The third major challenge concerns the quality of health systems. In this context, it is necessary to pay attention to population outcomes and thus to disparities. The attention to quality assessment in the U.S. focuses more commonly on health services than on health systems.

She stressed that population health is not “the sum of individual health” — noting for example the need to know the average birthweight of different sub-populations, not the population as a whole, in order to understand health disparities. The distinction between the focus on individuals and the focus on populations or subpopulations, she observed, is at the heart of the distinctions among the branches of medicine. She outlined a continuum including clinical medicine, clinical epidemiology, social medicine, community medicine, and public health, each centered around a different question and a different notion of risk.

The key question in public health is, “What characteristics are most salient in improving overall health and the distribution of health in populations, and what does evidence suggest should be priorities for intervention?” Here the focus is on attributable risk. The focus on specific diseases that is central to other branches of medicine is less useful in this context, where the relative balance, frequency and impact of diseases in populations is important.

She showed two schematics of influences on health, contrasting individual and population-level views. The latter schematic is similar to the one in the report on 21st century health statistics. The population-level or public health view pays attention to both average health (both occurrence and severity) and distribution of health (equity). At this level, she noted the interactions among contextual factors such as environmental characteristics and economic development and the fact that disadvantage in any one of them creates greater vulnerability in the others—an important factor in co-morbidity. Like community medicine, the public health approach focuses heavily on the political and policy context. The sum total of this view is the ability to look at historical health disadvantage.

First, information is needed on the linkages between individual/ aggregated individual data with contextual ecological data. Second, information is needed on the areas where people live and work and the distribution of social and political power in each area. Information is also needed on health services, framed in terms of people’s problems, not their diseases, and also attentive to co-morbidity — which she called “a real challenge to a health system that we aren’t even thinking about meeting.” Data systems also must allow for coordination among different providers and types of providers. She showed data from Maryanne van den Akker contrasting ratios of observed and expected (co-)occurrences of diseases, overall and for different ages, noting the nonrandom occurrence of disease in different groups.

After citing a definition of health adopted in the Ottowa Charter in 1986 and widely accepted since then, Dr. Starfield discussed how population health is measured. The alternatives include diagnosed morbidity case mix by age and DALYs; the approach she regards as especially promising is Profile Types, which has been used to characterize children’s health. At a minimum, she asserted, population health measurement should use stratified analysis (levels of health within major subgroups) rather than statistical adjustment.  She observed that Healthy People 2010 “talks a lot about disparities but doesn’t give you any idea of what you should do about them because it has no feeling for what is causing the disparities.” An important future direction is understanding the variety of influences on health — which NCHS and AHRQ are facilitating by making it possible to link individual and area-level data.

In summary, Dr. Starfield reiterated that population health is not the sum of individual health, and averages conceal information about systematic differences in health and thus about how they can be remedied. Looking only at the sum of individual health misses key information about co-morbidity and the effects of the non-random distribution of health associated with age, geography, and societal differences.

A Health Plan Perspective on the 21st Century Health Statistics Vision

—Carl Volpe, Ph.D., WellPoint

WellPoint is currently the second largest health insurer in the U.S., and Dr. Volpe characterized it as “the most market-oriented health insurance company” in the country. Three-quarters of WellPoint’s business is through PPOs, with services provided through contracts with physicians and hospitals. He said his remarks would provide a contrast with the preceding panelists’ perspectives, while he cautioned that every health plan is unique.

WellPoint’s mission is “to provide health security by offering a choice of quality branded health and related financial services” for its customers. Its emphases on health security, meeting changing expectations and a lifelong relationship are all underpinned by data systems. These data characterize the transactions between purchasers, payers and providers, all related to services to health plan members. The level of analysis is individuals and purchasers, the latter ranging from small companies to ones covering several hundred thousand lives. The data systems are for business operations and generally are not empirically derived.

Most information is not publicly available, for competitive reasons. Indeed, Dr. Volpe said WellPoint and other plans have a “strong bias against the use of our data for policy development” because the data could reveal business and market strategy.  Among the criteria in assessing a data request for public policy purposes, is whether plans can derive a benefit themselves , as well.

The areas of agreement with the health statistics enterprise include the value of data to measure and improve population health, the need for data standards, the need for strong but reasonable privacy and confidentiality standards, and the need to recognize the influence of certain disease states on population health. Dr. Volpe noted the trends in health plans toward a multipronged emphasis on health improvement and physician quality improvement as well as appropriate drug usage and early epidemic detection. With 70 percent of their dollars supporting the sickest 8 percent of members, the focus of most health plans is strongly on helping that small group of members improve their health status while reducing their need for health services. This is done through disease management, wellness, and prevention programs, working with members to change their behaviors.

With quality improvement efforts, one tool is physician scorecards, to help patients choose the best providers and to give doctors feedback on their performance. WellPoint is also part of the Council for Affordable Quality Health Care, which pooled data on antibiotic prescribing and had it analyzed by a third party, which informed physicians of their practice patterns. The project was done in cooperation with CDC. In another domain, early epidemic detection is possible because of the company’s prior authorization process, which generates information on utilization patterns. WellPoint has done a pilot project with CDC on this — an example of the ways in which health plans, although they are “playing at the margins” because of their differing missions, nevertheless “can contribute to the [public policy] effort.”

Finally, he cited several areas for future collaboration, including standard quality outcome measures, standards for collecting race/ethnicity, SEP and primary language data, EMR standards, and expanding health improvement programs. He stressed that the lack of EMR standards is “holding the nation up in terms of accountability”; and he noted that health plan data can help articulate population health, even though this will remain a secondary function. He pointed out that the words “population health” are now emerging in the private sector, although using a less rigorous definition and serving more market-driven purposes.

Discussion

Dr. Fitzmaurice pointed out, and Dr. Volpe agreed, that health plans can use population health activities as a tool to improve their cost-benefit relationship.

Dr. Mays asked Drs. Friedman and Starfield to comment on what the various NCVHS subcommittees and workgroups should take away from their presentations about how they do their work. Dr. Starfield suggested that they “think about how we could identify individuals without identifying individuals.” Dr. Friedman stated that public health needs to do a better job of making the case for why the use of data is important to the nation as a whole; as a result, people here are less willing to share data than are people in countries doing a better job of marketing the importance of population health information.

Mr. Hungate asked a series of questions about handling variations in risk in patient populations with respect to physician profiling. He spoke of the need for a public/private partnership to supply this information, using standard methods.

Dr. Lumpkin proposed that the utility of population health information will increase as more clinicians use electronic health records, thereby reducing the cost of clinical data. Dr. Volpe pointed out that the other issues are standards and interoperability. Dr. Starfield stressed that even with the EHR, the analytic context and the questions asked of the information will remain critical.

Ms. Handrich commented that even “visionary and positive” health plans seem to have no interest in reporting data to states for their use for population health purposes. The challenge stemming the differing public and private sector perspectives, she said, lies in finding a convergence of interest that would enable the use of information for the benefit of both the private sector and the public at large.

Dr. Localio pointed out that the leading causes of death compiled by NCHS do not include adverse events from medical care, and Dr. Starfield agreed with him that this reflects a deficiency in the way information is reported.

In conclusion, Dr. Lumpkin observed that this panel discussion is part of the Committee’s ongoing effort to follow the impact of its reports. Invited to comment, Dr. Sondik said the foregoing discussion offers “new thoughts on absolute fundamentals” and should be treated as a benchmark. The health statistics vision provides an unprecedented target and long-term vision to build toward. The identification of influences on health is a guide for data collection as well as goal-setting like what the CDC is currently engaged in. Dr. Sondik also hailed Dr. Volpe’s perceptions about the health care industry’s growing interest in behavioral health.

Quality Report — Mr. Hungate

After thanking those who contributed to the Quality Workgroup report, Mr. Hungate reviewed its structure and contents, noting that the report focuses on care provided in hospitals and physician offices and offers high-level recommendations about the data needed to monitor and improve it. He invited comments on the report and the process for moving forward.

Focusing on the process, Dr. Cohn asserted that it would be useful to get reassurance from the industry and others that the issues identified in the report are still pressing and that this is “the right agenda.” He argued that those who presented to the Committee over the years on data issues in quality measurement are “narrow experts” and not those would have to implement the Committee’s recommendations. He proposed that the Committee accept the report as a draft, hold hearings, and then develop a final report. This stimulated a lengthy discussion of process. Other suggestions included:

  • Asking various subcommittees and workgroups to comment on the significance and relevance of the issues in their respective areas.
  • Referring specific recommendations to NCVHS subgroups for follow-up.
  • Having reactor panels comment on the report.
  • Sending the report out and asking for comments as to whether each issue is understandable and actionable.
  • Finding a way to get closure and move beyond the document, while using it to help set the agenda for future actions.
  • Accepting the document as a report of the Quality Workgroup.
  • Pulling some recommendations out into letters.
  • Reframing the high-level recommendations as “candidate recommendations” that identify issues and collectively set the quality agenda for the entire committee and its subgroups — thus reinforcing the understanding that different issues call for different timetables and strategies.

Several members spoke in favor of the last idea listed. The Quality Workgroup was charged with returning on day two of this meeting with proposed simple modifications to the document, based on this discussion, as well as suggestions for a process for moving forward. The group then discussed the content of the report, resulting in a few editorial suggestions.

Status report, Subcommittee on Populations — Dr. Mays

As background to the report that will be submitted by the Subcommittee at the June meeting, Dr. Mays explained that the Subcommittee began a series of hearings in February 2002 on how well the OMB guidance on the collection of race and ethnicity data was working. They heard testimony on population-based surveys, from the states about vital statistics, and about specific racial and ethnic minority subpopulations. The hearings have already resulted in several letters to the Secretary. The forthcoming report will include a small number of general recommendations.

The group then recessed into Workgroup and Subcommittee meetings.

—DAY TWO—

Update from the Department

  • Data Council — Jim Scanlon, ASPE

Mr. Scanlon noted the presence of new staff for various subcommittees and a new liaison to the Subcommittee on Populations from the Census Bureau.

The workshop report of a National Academy of Sciences study of the adequacy of race and ethnicity data in public and private sector systems was released in December. Mr. Scanlon called attention to the section on private sector data collection. The full deliberative report will be available in April, and a presentation to the Committee is planned for June.

The HHS Council on the Application of Health Information Technology is meeting regularly and working to coordinate the Department’s work in this area with public and private sector and research partners.

The Department recently released the final rule for bar-coding standards for human drugs and biological and blood products. This is intended to support the infrastructure for several bar-coding systems and patient safety systems.

The Department now has a 2004 budget. It includes several NHII, data standards, data policy and population statistics initiatives, some of which Mr. Scanlon described. $3 million are budgeted for the NHII initiative, and $10 million for standards.

The President’s 2005 draft budget is promising in terms of NCVHS priorities, and it provides continuity (and in some cases growth) for previous projects. Although it is essentially a no-growth budget, it includes some positive developments for population statistics, with most major data systems continuing at their current services level through 2005. Questions remain about how the National Children’s Study will be funded. The highlight is a large increase of almost $25 million for NCHS, to stabilize core data systems.

Mr. Scanlon had these status reports on the Department’s responses to NCVHS recommendations:

  • Two sets of CHI recommendations have been adopted and the others are being reviewed.
  • The PMRI priorities and standards have been shared with the Data Council.
  • The Department has been waiting to see the budget before responding to the population statistics recommendations.  He described preliminary efforts around targeted surveys and promised more information later.
  • The Department has sent letters about the ICD recommendations and on departmental participation in promoting standards for information technology.
  • The privacy recommendations have been shared with OCR.

Dr. Lumpkin commented that the signs from Congress are that things do not look good for public health in the 2005 budget.

  • HIPAA Data Standards and CHI — Maria Friedman, CMS

The Department published the National Provider ID regulation in January, to take effect on May 23, 2007 for large providers and a year later for small ones. Information on the regulation is available on the CMS Web site, www.cms.hhs.gov/hipaa/hipaa2.

Two-thirds of Medicare transactions are now HIPAA-compliant. CMS has announced that the payment cycle for non-compliant claims to Medicare has been pushed back from 14 to 28 days, starting July 1, 2004. CHI has begun work on phase 2 of its work plan.

On enforcement, CMS has received 66 complaints, of which 53 were valid, 13 were closed at the complainant’s request, and 40 are now being processed. There are plans to put out the NPRM on the national health plan identifier this year, probably late this summer. Also on the regulations agenda is an NPRM for claims attachments.

Dr. Lumpkin asked for a future briefing on the impacts of the Medicare reform law. Ms. Berek promised a panel of people to cover all the pieces.

  • HHS Implementation of HIPAA Privacy Rule Compliance—Susan McAndrew, OCR

OCR had received 4,755 complaints as of the end of February 2004. It has closed 43 percent of the cases. Complaints are predominantly allegations of the misuse or improper disclosure of information. There are complaints about inadequate safeguards and the inability of people to get their information. Most complaints come from interactions between patients and doctors and are filed against large private practitioners.

Compliance dates are coming up: small health plans must be in compliance by April 15, 2004, and that is the end of the grace period for getting business associate contracts in place. Later this summer, OCR will deal with the Medicare drug card sponsors as a new group of covered entities — representing a new avenue of potential complaints. OCR continues to work on guidance through FAQs, presentations, and other means. It looks forward to the Subcommittee on Privacy and Confidentiality’s report on its hearings.

Discussion

Mr. Houston reiterated his past request for statistics on the breakdown of complaints by ty pe of covered entity, including physician offices versus health plan, and by type of complaint.

Dr. Steurle proposed a qualitative cost-benefit assessment of the privacy regulation. Dr. Lumpkin suggested that the Privacy Subcommittee draft a letter to the Department with this request, noting that a question about the impact might be added to an existing survey.

Mr. Reynolds reinforced these requests, noting that “the industry is hungry for facts” that would illuminate the Department’s notion of what is and is not a violation, to “start putting real information behind the myth.”  He predicted that many people would be willing to help in this effort.

Mr. Blair cautioned about the “concerns” that are being mistakenly circulated (e.g., in listservs) and that play into the “confusion and misunderstanding” surrounding the privacy regulation. He urged that OCR’s educational campaign reach out to the general public to promote understanding of “what is true and what is not true” about the regulations and their intent.

Dr. Lumpkin suggested that the Privacy Subcommittee work with OCR to develop a report.

IOM Report on Patient Safety — Philip Aspden, Ph.D., IOM

Patient Safety: Achieving a New Standard for Care was released in November 2003. Dr. Cohn, a member of the IOM committee that produced this report (Committee on Data Standards for Patient Safety, chaired by Dr. Paul Tang), introduced Dr. Aspen, who directed the study. Dr. Cohn said the report presents an exciting vision of patient safety, one that is consistent with NCVHS priorities and recommendations. He predicted that the IOM recommendations would help accelerate progress in this area.

Dr. Aspden said the IOM Committee included people with experience in IT and clinical data standards issues, several clinicians, a patient representative, and an expert in near-miss analysis. The Institute has been working on quality of care issues for several years and has conducted a major study and a series of reports on the subject. One recommendation of its Quality Chasm report was that higher quality care would require “redesigned systems of care, including the use of information technology to support clinical and administrative processes.” The new Committee was charged with producing a detailed plan to facilitate development of data standards applicable to patient safety, identify key standardization issues, and provide guidance to DHHS on a set of key capabilities for electronic health record (EHR) systems.

Studies have concluded that as many as 98,000 annual deaths are attributable to medical error. Dr. Aspden showed findings from the Harvard Medical Practice Study of adverse events. NCVHS member Dr. Localio, a co-investigator on the study, commented on the methodology and findings. The Harvard study, like the IOM Committee, looked at errors both of omission and commission. Dr. Cohn observed that errors of omission have not been part of the patient safety vision over the last 20 years, an oversight the new IOM report hopes to remedy.  Dr. Aspden also cited a Rand study by Beth McGlynn that found that only 55 percent of patients receive the appropriate type or level of care.

The IOM Committee revised the IOM definition of an adverse event to include omission as well as commission. It was also very interested in near misses, defined as an act of omission or commission that could have harmed the patient but did not as a result of change, prevention, or mitigation. Near misses are believed to be precursors of adverse events, and it is easier to collect sufficient data on them because they are more numerous. In addition, they include recovery procedures that can provide insight.

The Committee issued seven recommendations, the first of which calls for improved information systems in all care settings and also calls on health care organizations to implement comprehensive patient safety systems that provide immediate access to patient information and decision-support tools and capture patient safety information as a byproduct of care. (Project webpage:http://www.iom.edu/project.asp?id=4629]

The Committee’s work on the EHR followed from an “add-on charge” from DHHS that came midway in the process, aimed at finding ways to link incentives to functionalities of EHRs in order to encourage investments in them. They looked at the care-related functionalities of EHRs in inpatient, outpatient, nursing home, and community care settings. (The last was transmuted to the personal health record.) Among other things, they identified a realistic timeframe for implementation. The report on this subject is posted on the IOM Web site.

Mr. Blair reported that HL7 took this information as input, and its forthcoming functionality model standard will be for the most part compatible. Dr. Deering added that for the first time, HL7 is using an open ballot in which anyone who pays $100 and registers may vote.

In general, the IOM Committee recommended a systems approach to patient safety, with information technology and thus clinical data standards playing pivotal roles. It looked at standards for clinical data, data interchange, terminology, and knowledge representation. Its other recommendations on patient safety are in the following areas:

  • establishment of the NHII
  • the key role of federal leadership
  • a detailed work plan for standards development
  • comprehensive patient safety programs
  • a paradigm shift from a retrospective to a prospective approach to patient safety
  • an applied research agenda
  • reporting systems

The recommended paradigm shift would involve a focus on prevention, the analysis of care processes, and fostering a culture of safety rather than blame, as well as the inclusion of errors of omission and near-misses. Research is needed in three areas: knowledge generation, tool development, and dissemination. The Committee offered detailed recommendations on what should be included in a patient safety event taxonomy, to be developed by AHRQ and incorporated into SNOMED CT. Finally, Dr. Aspden said the Committee recommended that Congress authorize and fund HHS to lead and maintain a public/private partnership for the promulgation of data standards for patient safety, and to help accelerate the development of certain standards.

Dr. Cohn called attention to the work on standardized report formats, and commented on the Committee’s conclusion that there needs to be both codified data and free text.

Discussion

Mr. Hungate commented on the chasm of trust between the patient/health seeker, the provider, and the payer, with patients inclined to believe that policies and procedures protect providers or payers but not them. He cautioned against the inevitable diminishment of trust as more thorough reporting of adverse events creates the appearance, at least, of a growing number. He asked how “an increasingly uncomfortable public” could be persuaded that “this really is doing something good for you” — possibly through early deliverables that show progress in terms that make sense to people as beneficial for them. Dr. Aspden said the Committee was aware of this issue, which is also evident in the literature, but it did not try to think through how to overcome the chasm.

Dr. Fitzmaurice said the report is helpful to AHRQ and its patient safety program, and he noted the several complementary initiatives in this area. He argued for targeting the most severe errors in the short run.

Mr. Reynolds commented on the complexity of implementation issues, contrasting the likelihood of successful EHR implementation by federal CHI “closed panel” institutions with the lower likelihood in the private sector.

Dr. Steinwachs noted the “interesting roles” for the patient and consumer that are implied in the IOM report, particularly related to how they can interact with the EHR to ensure that it is correct and complete. Dr. Lumpkin noted that the NHII Workgroup plans to focus on the personal health dimension, and the Markle Foundation initiative Connecting for Health is currently doing so as well.

Mr. Localio remarked on the immense cost involved in carrying out the recommendation for a robust applied research agenda on patient safety. Dr. Cohn said the place to begin is with the low-hanging fruit, such as e-prescribing.

Dr. Lumpkin pointed out the immense potential savings to be realized from improving patient safety. In a related area, HHS has estimated that instituting the NHII would save the health system $120 billion. He noted, however, that the models show that savings from quality improvement mostly accrue to payers, not providers; the question is how to appropriately align costs, incentives and rewards in a way that moves the agenda forward. The Committee should look at this question of how to help create the environment in which the competitive milieu pushes the system in the right direction through the use of information technology.

In conclusion, in thanking Dr. Aspden, Dr. Cohn observed that at best, the future holds a convergence of patient safety, e-prescribing, data standards and NHII. The standards work of the IOM will be regarded as an important foundation for building this structure.

HIPAA 6th Report to Congress — Dr. Cohn

After brief discussion and editorial suggestions, the Committee passed a motion that the report will be revised per this discussion and sent to all Committee members for a comment period, after which the Executive Subcommittee is authorized to finalize the report and send it to Congress.

Subcommittee and Workgroup Reports

  • Subcommittee on Privacy and Confidentiality

Mr. Houston read aloud a revised version of the letter to the Secretary discussed the previous day. Members discussed the terminology in one passage in the letter and a proposed revision related to accounting for disclosures. In the latter instance, the Privacy Subcommittee was asked to study the matter further and possibly bring forward a future recommendation on it. After discussion of a few additional modifications, the Committee passed a motion approving the letter, as revised.

  • Subcommittee on Standards and Security

Dr. Cohn read aloud a revised version of a letter to the Secretary discussed the previous day, concerning claims attachments. The Committee passed a motion approving the letter as read.

Dr. Cohn then announced the hearing schedule for the remainder of 2004, with hearings scheduled for March, May, July, August, September, November, and December, plus a Subcommittee meeting in October. (See NCVHS Web site for dates and topics).

  • Subcommittee on Populations

Dr. Mays reported that the Subcommittee now has a strong complement of members and staff and it will start developing its work plan, to include work on mental health statistics, targeted surveys, and other matters. The Subcommittee will comment on race and ethnicity data collection issues in a forthcoming journal article.

  • Workgroup on Quality

Mr. Hungate reported that the Workgroup is revising its report around the idea of candidate recommendations, as discussed in the previous day’s meeting. The Workgroup expects to conduct hearings in June as the next step in moving ahead on the first set of eight candidate recommendations, those concerning assessing health care and health outcomes. It will work in consultation with the Subcommittee on Standards and Security in planning the hearings. Dr. Lumpkin suggested that the hearings be designed to make the business case for the measurement of health care quality, and that the SDOs then be invited to be presented with the business case and to suggest how they would move forward.

The Workgroup leaves it to other NCVHS subgroups to decide how to move ahead with the candidate recommendations in their domains.

After considerable discussion to clarify the process for the next few months, the Committee agreed that because the candidate recommendations will be unchanged from the present version reviewed by the full Committee, it will not be necessary for the full Committee to discuss the next iteration of the Workgroup’s report. They approved a motion that the revisions will be reviewed by the Executive Subcommittee, which is authorized to approve the report if it determines that the revisions are not substantive.

  • NHII Workgroup

Dr. Lumpkin reported that the Workgroup held a day-long meeting to plan the HHS NHII conference, and it will meet on April 9 for long-term planning. The issue of NHII architecture sparked a good deal of discussion, and the Workgroup will pursue the subject. Ms. Greenberg said any NCVHS member who wishes to will be supported to attend the July 21-23 NHII conference. At the end of the conference, the NHII Workgroup will conduct a hearing on reports from the various conference breakout sessions, followed by a Workgroup meeting.

Future agendas for NCVHS meetings

Forthcoming meetings are:

  • June 16-17
  • September 1-2
  • November 4-5

Items for the June meeting include presentations from the CDC director’s office about the Futures Initiative, the IOM report on race and ethnicity, and Medicare reform legislation. Action items will probably include a report from the Subcommittee on Populations and a letter from the Subcommittee on Privacy and Confidentiality.

Ms. Greenberg reported that she and Dr. Lumpkin met with the CDC Director’s Advisory Committee in February, and they were told the Futures Initiative will be an iterative process.

Mr. Scanlon noted that NIH has just completed a strategic planning effort called the NIH Roadmap, which aims to strengthen the relationship between basic research and bedside clinical practice.

Dr. Steinwachs suggested a briefing on a CDC-funded environmental health tracking initiative; Ms. Greenberg offered to work with him on planning a briefing for the Fall.

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.

 /s/ John R. Lumpkin                                                    5/17/2004

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Chair                                                                              Date