Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

February 22-23, 2006

Hubert H. Humphrey Building
Washington, D.C.

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on February 22, 2006, at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:

Committee members

  • Simon P. Cohn, M.D., M.P.H., Chair
  • Jeffrey Blair, M.B.A.
  • Justine M.Carr, M.D.
  • John P. Houston, J.D.
  • Stanley M. Huff, M.D.
  • Robert W. Hungate
  • A. Russell Localio, Esq., M.A., M.P.H., M.S.
  • Carol J. McCall, F.S.A., M.A.A.A.
  • Harry Reynolds
  • Mark A. Rothstein, J.D.
  • William J. Scanlon, Ph.D.
  • Donald M. Steinwachs, Ph.D.
  • C. Eugene Steuerle, Ph.D.
  • Paul Tang, M.D.
  • Kevin C. Vigilante, M.D., M.P.H.
  • Judith Warren, Ph.D, R.N.

Staff and liaisons

  • Marjorie Greenberg, NCHS/CDC, Executive Secretary
  • James Scanlon, ASPE, Executive Staff Director
  • Karen Trudel, CMS liaison
  • Virginia Cain, Ph.D., NIH liaison
  • Ed Sondik, Ph.D., NCHS liaison
  • Steve Steindel, Ph.D., CDC liaison
  • Irma Elo, Ph.D., NCHS Board of Scientific Counselors liaison

Others

  • Julia Holmes, NCHS
  • Lynn Boyd, Amer. College of Pathologists
  • Laura Blum, JCAHO
  • Evelyn Kappeler, HHS/OSOPHS
  • Amy Harper, NLM
  • Judy Frazier, Amer. Optometric Assn.
  • Frank Kyle, Amer. Dental Assn.
  • Kelty Lavin, Analyst
  • Dan Rode, AHIMA
  • Tina Hough, CDC
  • Ashley Henderson, Wexler & Walker
  • Michael DeCarlo, BlueCross BlueShield
  • Carol Bickford, Amer. Nurses Assn.
  • Jason DuBois, Amer. Clinical Laboratory Assn.
  • Donald Horton, LabCorp
  • Bill Head, Medco
  • Miryam Granthon, OMH
  • Samantha Chao, IOM
  • Jayne Chambers, Federation of Amer. Hospitals

EXECUTIVE SUMMARY

UPDATE FROM THE DEPARTMENT

  • Data Council— James Scanlon, ASPE
  • Privacy Rule Compliance—Sue McAndrew, OCR
  • HIPAA implementation—Karen Trudel, CMS

Mr. Scanlon reported that the President’s 2007 budget funds accelerated HIT adoption and continues the nation’s core statistical programs. An interdepartmental Council on Health Information Technology has been established. The Data Council has initiated a study of standards used in its data collection and statistical systems. It will hold a workshop to look realistically at the potential for using links to EHRs in some surveys, with NCVHS assistance. It has added a searchable web portal on race and ethnicity data.

Dr. Cohn introduced and welcomed Winston Wilkinson, the new Director for Civil Rights for HHS. Ms. McAndrew reported that OCR had received 17,656 complaints as of the end of January, closing 71 percent and referring 285 cases to the Department of Justice. The group discussed the uses of these data for evaluation and education. The Department will continue to stress and facilitate voluntary compliance.

Committee members accepted Ms. Trudel’s offer of a future briefing on the enforcement rule and process. CMS is compiling the responses to its request for information regarding the PHR; the summary will be on the CMS Website by April.

The discussion period focused on the need for a broad evaluation of the status of privacy and confidentiality and, in that context, the effectiveness and costs/benefits of HIPAA. The challenges of measuring the cultural change effected by HIPAA were noted.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER ON HIPAA ROI —Mr. Reynolds

The Subcommittee had circulated to Committee members a draft letter to the Secretary on the HIPAA return on investment (ROI), but Mr. Reynolds reported that it was subsequently withdrawn in favor of a more holistic review of HIPAA, marking its tenth anniversary, with more actionable recommendations. The Subcommittee expects to submit it for action in June. Committee members supported this decision and offered suggestions for the letter.

UPDATE ON ONC: AHIC DEVELOPMENTS, CONTRACTS, COORDINATION, NHIN ARCHITECTURE—David Brailer, National Coordinator for HIT

Dr. Brailer said most of the pieces were now in place to provide the vehicle for HIT plans to become manifest. He described the context into which the pieces fit. As designed, the process has both long-term and short-term efforts. The long-term approach includes laying the foundations for collaborative, voluntary standardization in the industry, a certification process, the health information security and privacy collaboration, and monitoring of EHR adoption. Superimposed on these activities are the breakthroughs being developed by AHIC, which are to take place in one to three years. He said he hoped NCVHS (a “sibling” to AHIC) would help create the long-term infrastructure and create a vessel for moving the recommendations by and to AHIC out to industry and in to government.

The discussion period generated several suggestions from Dr. Brailer about ways for NCVHS to contribute. He asked the Committee to be in dialogue with AHIC and its contractors as recommendations emerge; to help create “receptor sites” for recommendations on the infrastructure; to help address the “weak links” of evaluation and human resources for the clinical transformation (including the issue of training); and to provide an atmosphere of realism and public legitimacy.

COMMITTEE STRATEGIC PLANNING

The members agreed that they would like a full-Committee retreat this June, following the full Committee meeting. They talked about what topics and processes would be most beneficial and suggested a long list of topics and a few broad questions. They agreed to produce a structured list of possible NCVHS activities and share it with Dr. Brailer, Dr. Sondik, the NCHS BSC and others, for input prior to the retreat.

SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY—UPDATE ON NHIN REPORT AND RECOMMENDATIONS—Mr. Rothstein

The Subcommittee on Privacy and Confidentiality plans to submit a report on privacy and confidentiality issues in the NHIN in June. It will circulate a draft report to the full Committee and ask for comments and discussion prior to that meeting. It has reached agreement on 28 recommendations, 12 of which are contained in a discussion document prepared for this meeting. Mr. Rothstein read through and commented on the dozen recommendations. A rich discussion ensued, in some cases particular to specific recommendations and in others, more generally about process and tone. They agreed on the importance of making the Committee’s recommendations to the Secretary as decision-ready as possible.

IOM REPORT BRIEFING—PERFORMANCE MEASUREMENT: ACCELERATING IMPROVEMENT—John Ring, M.D., Institute of Medicine

Dr. Ring was recently appointed as Director of the Board on Health Care Services at IOM. Congress mandated the present series of studies and reports through the Medicare Modernization Act of 2003, calling for reports on performance measurement, the pay-for-performance program (P4P), and Medicare’s Quality Improvement Organization (QIO) program. The first was released in December; the others are scheduled for release in March 2006 (on QIOs) and July 2006 (on P4P). HHS is the sponsor. The first report stresses the need for a well-coordinated national system of performance measurement to replace the current voluntary, fragmented, consensus-based “non-system.” It also recommends supplementing and strengthening (not replacing) current activities in the public and private sectors and establishing a new, independent National Quality Coordination Board with oversight, coordination and direct action functions.

In the discussion period, NCVHS members commented on the importance of engaging providers and patients in local solutions, harmonizing and consolidating measures, and exploiting HIT for quality purposes.

BRIEFING ON DATA ISSUES AND OPPORTUNITIES FROM HURRICANES KATRINA AND RITA—Mr. Scanlon

Mr. Scanlon described the Department’s involvement in the hurricane relief effort and in planning for future emergencies. A report on the federal lessons learned has just been released and posted on the White House Website, with 125 recommendations. HHS provided first-response health and public health services and facilitated access to human services. The lack of interoperable communications among first responders was a core issue. The experience demonstrated the potential value of EHRs as a source of basic information on people’s health history and medications. HHS and other organizations helped victims get access to prescription drugs. Applying this experience to lessons for the future, there is talk now of creating an “EHR-light” or “first-response EHR” for essential information; HHS will probably be asked to look into this. It also saw and met the need for basic, daily information on hospitals and emergency departments, and it is looking into how to construct such a database for the nation. Another database is needed to compile and evaluate human services need and resources in future events. To study the overall impact and get a sense of people’s current status and plans, NIMH is conducting a major study of 2,000 Katrina victims using quarterly telephone interviews. They will have basic tabulations by April.

In the discussion period, NCVHS members commented on ways the Subcommittee on Populations might contribute to work in this area, and on the importance of situational awareness and communication in emergencies.

NCHS DATA RELEASE AND CONFIDENTIALITY ISSUES FOR VITAL STATISTICS; BOARD OF SCIENTIFIC COUNSELORS (BSC) UPDATE—Dr. Sondik and Dr. Elo

The states, the voluntary source of vital statistics, have asked NCHS to review its current policy on releasing these data out of concern that the policy conflicts with state laws and regulations. (There have been no known breaches, nor public complaints.) NCHS has proposed four types of release to the national public health information organization, NAPHSIS, which has responded with its own proposal. Discussions continue. There is serious concern that the vital statistics information that is the foundation for knowledge on the population’s health is at risk. The Committee offered several suggestions of ways to address this concern. Dr. Elo, the new liaison of the NCHS BSC, said the BSC recommends that non-governmental data users be involved in discussions with state registrars. Participants agreed that this topic would be a good one for a joint meeting of NCVHS and the BSC. Dr. Cohn asked the Subcommittee on Privacy and Confidentiality to monitor it.

Dr. Sondik, Dr. Elo and Dr. Bill Scanlon briefed the Committee on the BSC’s recent review of NCHS mortality programs. The review generated useful recommendations  and provides a model for future reviews, the next one of which will be of reproductive statistics activity. Dr. Elo also said that joint efforts with NCVHS on data linkage issues would be useful.

SUBCOMMITTEE AND WORKGROUP REPORTS

(See brief summaries below.)

DETAILED SUMMARY

—DAY ONE—

CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA

Dr. Cohn called the meeting to order. Following introductions around the room, he reflected on the events and accomplishments of 2005, notably the Katrina disaster and the launching of the Secretary’s 500-day plan and of the e-prescribing rule. The National Committee released reports on personal health records and eliminating health disparities, and laid groundwork for reports on privacy and other topics to be released in 2006. He noted that 2006 marks the tenth anniversary of HIPAA. He welcomed Dr. Irma Elo, a professor of demography and sociology at the University of Pennsylvania, as the new liaison from the NCHS Board of Scientific Counselors (BSC).

UPDATE FROM THE DEPARTMENT

  • Data Council— James Scanlon, ASPE

The President’s FY2007 budget, sent up in early February, includes continued support for the acceleration of EHRs and health information technology, through funding for ONC, AHRQ and ASPE. An interdepartmental Council on Health Information Technology has been established to coordinate federal HIT policy such as that on breakthrough ideas arising from AHIC. In the population health area, there is enough funding to protect the core HHS statistical systems. Mr. Scanlon will brief the Committee on day two about the Department’s work on emergency preparedness and the Katrina response. He called attention to an updated OMB guidance for statistical surveys as well as a draft bulletin on standards and best practices for risk assessments. The Data Council has initiated a study of standards used in its data collection and statistical systems and is looking for opportunities to integrate them in future surveys.

NCHS and other agencies have asked the Data Council to look at the potential for using links to EHRs in some surveys. It expects to plan a workshop to look at this question in a realistic and “tough-minded” way, and will ask NCVHS to help plan this event. The Council has added a searchable web portal on race and ethnicity data to the HHS Website. It is also looking at cost-effective ways to improve the data on race and ethnicity, prescription drug use and expenditure, health insurance, state data on care utilization and health insurance, and public health emergency preparedness.

  • Privacy Rule Compliance—Sue McAndrew, OCR

Dr. Cohn introduced and welcomed Winston Wilkinson, the new Director for Civil Rights for HHS, and noted the close working relationship between OCR and the Committee.

Ms. McAndrew then reported that OCR had received 17,656 complaints as of the end of January, closing 71 percent and referring 285 cases to the Department of Justice. OCR is working to refine its data on complaints. OCR and CMS issued the final enforcement rule in mid-February, to take effect March 16.

  • HIPAA implementation—Karen Trudel, CMS

At Ms. Trudel’s suggestion, Committee members expressed interest in a future briefing  on the enforcement rule and process. On e-prescribing, she said the four pilots were moving forward, with significant assistance from AHRQ staff. The grantees will get together periodically to compare notes and discuss best practices. CMS is compiling the responses to its request for information regarding the PHR. In general, they urge CMS to facilitate the use of PHRs, to avoid building a “Medicare stovepipe,” to be mindful of privacy and security concerns, to bring its voice to the table with standards bodies and the certification process, and to play a strong role in education. The summary will be on the CMS Website by April. CMS is working closely with the consumer empowerment group of AHIC to ensure coordination.

CMS has enumerated almost 330,000 providers with the NPI; about 50,000 are organizations. The data dissemination notice is targeted for Federal Register publication in April. CMS is reviewing the comments on the proposed claims attachment rule, working with the SDOs. Ms. Trudel reported the high HIPAA compliance rates for the Medicare transaction 835 and progress on the 837. She stressed that CMS has responded to more than a million queries, indicating that people are making use of available information resources.

Discussion

Asked about measuring the benefits of HIPAA implementation, Ms. Trudel said there are few measurable pieces of data; she offered to collect whatever data the Committee requests. Dr. Tang commented on the merits of using Privacy Rule data to inform education efforts and measure the overall impact of HIPAA on information privacy. Mr. Rothstein said the greatest benefit of HIPAA is that it has changed the ethic of providers and patients, and this is difficult to measure. (Dr. Carr later suggested that JCAHO may be a source of trended data on compliance within hospitals, which would point to the cultural change.) Mr. Rothstein asked about the tracking of trends regarding facially invalid complaints and the use of the data to inform outreach and education efforts. Ms. McAndrew said these were good ideas; currently the system is used to inform programmatic decisions but little else.

There was a brief discussion of the public perception that there is greater difficulty and expense in accessing records in the wake of HIPAA. Ms. McAndrew said the privacy rule only allows providers to charge for copying costs, not for search and retrieval.

Mr. Houston asked if OCR planned to become more aggressive about enforcement now that the final rule is in effect. Ms. McAndrew said the Department still favored encouraging voluntary compliance as the best way to promote the desired cultural shift.

Dr. Steuerle, citing his perspective as an economist, commented on the need for a broad, cost/benefit approach to privacy and confidentiality issues that goes beyond HIPAA. He noted the social costs of privacy and confidentiality policies. Mr. Rothstein agreed on the importance of a broad perspective and noted that the Committee had written the Secretary two or three years ago recommending research on these questions.

Committee members praised the Data Council’s plans to take a realistic look at the potential utility of EHRs for population health work, noting that the Committee itself (notably the Quality Workgroup) has begun to explore this question.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER ON HIPAA ROI —Mr. Reynolds

Mr. Reynolds reported that the Subcommittee had circulated to Committee members a draft letter to the Secretary on the HIPAA return on investment (ROI), but subsequently decided to withdraw it to develop a more holistic review of HIPAA, marking its tenth anniversary, along with more actionable recommendations. They expect to submit it for action in June.

The Committee members universally supported this decision. Some suggested specific approaches or points to make in the new letter, including talking about the first ten years as a foundation for the future. Dr. Carr pointed out that John Halamka had reported to the Quality Workgroup about a clear ROI from using health information technology in Massachusetts. Others suggested that especially if privacy is in the scope of this review, the concept of ROI may be too narrow, in contrast with looking at benefits and lessons. Mr. Blair pointed out that because HIPAA compliance is mandatory, the industry has not approached it as an “investment.” Dr. Cohn noted that the forthcoming letter needs to be planned in conjunction with the Committee’s Congressionally mandated annual report on HIPAA implementation.

UPDATE ON ONC: AHIC DEVELOPMENTS, CONTRACTS, COORDINATION, NHIN ARCHITECTURE—David Brailer, National Coordinator for HIT

Dr. Brailer said most of the pieces were now in place to provide the vehicle for HIT plans to become manifest. He described the context into which the pieces fit, noting that ONC frames its task as creating the conditions for a marketplace in which the technologies will be widely available on a voluntary basis. As designed, the process has both long-term and short-term efforts. The long-term approach includes laying the foundations for collaborative, voluntary standardization in the industry, as well as a certification process that has already released ambulatory EHR certification criteria and has begun on inpatient EHR and network architecture certification. In addition, the health information security and privacy collaboration provides a leadership group for federal and state leaders around these issues. Finally, another activity is reviewing EHR adoption.

Superimposed on these activities is a set of breakthroughs being developed by AHIC, which Dr. Brailer described as the “the first cousin, if not the sibling” of NCVHS. The breakthroughs are to take place in one to three years and are highly visible and with clear value to a specific stakeholder group. He noted as “a concern” that while these are good starting points, they exist “in conflict with the long-term infrastructure” because they must be begun before the latter is fully in place. This will make it necessary, for example, to “titrate the breakthroughs with the standards.” However, it is necessary to do both at the same time because of the need to move rapidly. AHIC and ONC are both focused on linking and managing priorities between short-term needs and long-term coherence in this period of implementation. Dr. Brailer said the AHIC recommendations would produce “some pretty tough tasks” and difficult, but necessary, decisions. He hoped NCVHS would help create the long-term infrastructure and create a vessel for moving AHIC recommendations out to industry and in to government.

Discussion

Mr. Rothstein noted that the Subcommittee on Privacy and Confidentiality is finalizing a report on the NHIN and privacy and confidentiality issues. He asked how Dr. Brailer expected the Committee’s recommendations to work into the activities of the architecture groups. Dr. Brailer replied that the goal of the first round of contracts for the NHIN is to generate questions about public interests and architecture. The review of the first round is expected to inform a new round of bigger prototypes and more aggressive implementation. Noting that this is “a two-way street,” he invited NCVHS not simply to submit recommendations but to engage in an interactive dialogue with AHIC and its contractors as the designs and plans begin to emerge. He stressed that “none of us knows how this should work.” In general, the idea is to create practical experience to anchor the future developmental process, and dialogue, in reality. The Committee’s recommendations will also be filtered into the process of the Health Information Privacy and Security Collaboration. The participants in this collaboration will be designees from up to 40 states, and he described the process planned for them. The aim is for this group to be a new vehicle for a federal-state dialogue about security and privacy.

Many NCVHS members praised the energy and productivity of ONC activities. Mr. Reynolds encouraged thinking in terms of “tool sets” and hailed the prospect that the certification process will deliver a package of utilities to individual doctors that they can trust meets HIPAA, architecture and privacy specifications. Dr. Brailer said certification is viewed as “an absolutely necessary entry point for government policy” and a risk-reducer for private sector buyers. Potentially, all stakeholders can benefit. On the idea of tool kits, he said AHIC contractors are required to incorporate the use cases from the breakthroughs into their future work (e.g., medication history and secure messaging). As a result, EHRs should become increasingly multifaceted and valuable.

Dr. Steuerle urged Dr. Brailer to be very direct with the National Committee about how it can be most useful. He asked whether there would be an effort to raise incentive issues and related policy, such as through varied Medicare payments. On the first point, Dr. Brailer proposed that NCVHS create “receptor sites” to help the long-term infrastructure developments make their way into government thinking. He will work with the Committee to develop communication mechanisms. On incentives, he said there is a lot of discussion of this topic, generating many ideas; but AHIC has limited authority to make such things happen. He noted the need to “legitimize the economic treatment of these publicly beneficial private investments.”

Asked by Dr. Tang about strategies for evaluating the effectiveness of implementation, Dr. Brailer said evaluation and finding the human assets and knowledge base in the U.S. to bring about the clinical transformation are the “weak links” of the whole enterprise. They have been looking more closely at training, in which there is Congressional interest. He urged NCVHS to participate in this area.

Mr. Blair suggested gathering data to show quantitatively how each initiative shows an ROI, something that will be important in influencing the skeptics and dealing with difficult periods in the transition. Dr. Brailer talked about the potentially broad social benefits and the need to create a tipping point. He observed that while persuasion and enthusiasm are major motivators in bringing about change, he is also cautioning people not to be come “irrationally exuberant” about this topic. Again he called on NCVHS to provide an atmosphere of realism and public legitimacy.

COMMITTEE STRATEGIC PLANNING

In a brief discussion, members agreed that they would like a full-Committee retreat this June, following the full Committee meeting. They talked about what topics and processes would be most beneficial. The suggested setting clear goals for the retreat, possibly using a facilitator, having informal social times and chances to learn what each member brings to the table, and structuring in enough flexibility to allow for brainstorming. The specific topics and processes recommended included priority-setting, consideration of the receptor sites for the Committee’s recommendations, attention to the ways the Committee can support the Department’s health IT imitative, clarification of the relationship to AHIC, a look at what things are not being addressed as resources go toward the EHR, a review of how the Committee’s sub-groups work together and an evaluation of the Committee’s organizational structure, discussion of how to improve communication strategies, and an assessment of what relationships the Committee has and what new ones it needs to establish. One member suggested promoting realism by contrasting what members hear at NCVHS meetings and in other arenas such as their jobs. Broad questions for the retreat include, What is the National Committee on Vital and Health Statistics? and How does the Committee as a whole fit into the scheme of things, especially now that ONC and AHIC have been established? A member noted that the Committee’s visions for IT and health statistics helped bring about the transformation now under way, and the Committee needs to stay ahead of the transformation by planning the roadmap for how all the pieces fit together.

Dr. Cohn asked members to send him their desired retreat topics and priorities, to feed into the planning process. The group agreed to produce a structured list of possible NCVHS activities and share it with Dr. Brailer, Dr. Sondik, the NCHS BSC and others, for input prior to the retreat; alternatively, this could be an outcome of the retreat. Quality Workgroup members urged members to participate in the Workgroup’s forthcoming breakout session, which will help plow the ground for future thinking.

SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY—UPDATE ON NHIN REPORT AND RECOMMENDATIONS—Mr. Rothstein

The Subcommittee on Privacy and Confidentiality is working on a report on privacy and confidentiality issues in the NHIN that it plans to submit in June. It will circulate a draft to the full Committee and ask for comments and discussion prior to the June meeting. It has reached agreement on 28 recommendations, 12 of which are contained in a discussion document prepared for the current (February) meeting. Mr. Rothstein read through and commented on the dozen recommendations, which he described as “highlights.” Noting that these are complex issues to which the Subcommittee has given a great deal of thought, he expressed hope that the Committee could reach agreement in June on a document that will be of value to the government and the private sector.

Discussion   

A rich discussion ensued, in some cases particular to specific recommendations and in others, more generally about process and tone. (The reader is referred to the transcript for the details of the presentation and discussion.)

The Subcommittee’s draft recommendations fall into three categories or “paths,” largely based on the degree of agreement among members on the various topics. The three are straightforward recommendations; identification of issues to be decided by the Secretary; and issues requiring legislative action. It was suggested that the report clearly delineate these three categories and, when straightforward recommendations are not being made, to be as specific as possible about the actions (e.g., research or demonstrations) needed to lead to a decision. The principle is to make the recommendations as decision-ready as possible.

Members expressed appreciation for the opportunity to become familiar with the issues and the Subcommittee’s thinking in advance of having to make a decision on the recommendations.

The topic that generated the most discussion was the various interpretations, options and consequences related to opt-in and opt-out as bases for consumer decisions about including or excluding personal health information in the NHIN. (The Subcommittee recommends that the method by which health information is stored by health care providers, i.e., paper versus electronic, should be left to the health care providers.) Dr. Steuerle offered a number of comments and suggestions, based on his extensive experience with this issue in the realm of pension plans. In so doing, he added a dimension to the Subcommittee’s previous approach by suggesting alternatives to a uniform nationwide approach.

Faced with the complexity and range of views on these issues, the Committee talked about different scenarios for the report as a function of the extent of their agreement on a set of recommendations. Mr. Rothstein said the Subcommittee had worked hard to arrive at consensus among themselves, accommodating a wide range of views, and it hopes the full Committee will strive to do the same. Members were urged to participate in the conference calls on this report.

IOM REPORT BRIEFING—PERFORMANCE MEASUREMENT: ACCELERATING IMPROVEMENT—John Ring, M.D., Institute of Medicine

Dr. Ring was recently appointed as Director of the Board on Health Care Services at IOM. He acknowledged his predecessor, Dr. Janet Corrigan, who was the study director for the performance measures report and the two that will follow it in the “Pathways series.” He introduced Samantha Chao, who helped staff the study. All of the IOM’s work on health care quality addresses the low value—uneven quality, at considerable cost—of health care in the U.S., which is well documented. The IOM produced two seminal works on the problem in its “Quality Chasm” series, highlighting the severity of the problem and laying out a bold vision for quality. Congress mandated the present series of studies and reports through the Medicare Modernization Act of 2003, calling for reports on performance measurement, the pay-for-performance program (P4P), and Medicare’s Quality Improvement Organization (QIO) program. An IOM panel recommended three separate reports. The first was released in December; the last two are scheduled for release in March 2006 (on QIOs) and July 2006 (on P4P). HHS is the sponsor of the studies, and particularly CMS.

Performance measurement is regarded as the key to effecting all specific changes such as public reporting, clinical quality improvement and accreditation. The IOM study stresses the need for a well-coordinated national system of performance measurement to replace the current voluntary, fragmented, consensus-based “non-system.” Today, critical domains lack “owners” and will thus remain unaddressed, and conflicts of interest limit engagement while duplication and inconsistency lead to waste and heavy burdens on providers. In addition, knowledge exchange is limited. The IOM Committee recommends supplementing and strengthening (not replacing) current activities in the public and private sectors and, in particular, establishing a new independent board with oversight, coordination and direct action functions. It believes the federal government is the logical entity to play this role.

Dr. Ring then reviewed and discussed each of the six IOM recommendations. They spell out the duties and goals of the proposed National Quality Coordination Board; recommend the establishment of long- and short-term goals; stress the importance of local innovation; note that the existing work on performance measurement should be built on and integrated; recommend technical and financial assistance for providers, as needed;  and propose a “starter set” of performance measures for a variety of domains of care. They also address the need for a research agenda and appropriate financial resources. Finally, Dr. Ring recognized NCVHS member Dr. Paul Tang, a member of the IOM Board on Health Care Services.

Discussion

Mr. Hungate expressed frustration at the limited substantive change in quality improvement in the last two decades. He noted the limitations of “hierarchical” approaches and stressed the need for local solutions, with the engagement of professional societies. He also stressed the need for IOM leadership and for ways to get quality information to patients to help them make decisions. Dr. Ring said the physician provider community is very interested in participating in the process, and the IOM committee emphasizes local problem-solving and is very patient-focused. Accreditation organizations may be able to help advance the agenda.

Dr. Carr commented on the great burden on the providers and institutions trying to generate performance measurement data today, and asked about specific recommendations to harmonize measures and exploit the information infrastructure to build the IOM vision. Dr. Ring said the IOM Committee would like to collapse all the measures into a single set. He added that the Committee also emphasizes the necessity of doing away with unfunded mandates.

Mr. Blair asked about clinical decision support and continuous quality improvement, and was told that these topics are outside the scope of this report though not the series. Dr. Tang commented on need to develop measures that can leverage EHRs as a tool for quality improvement. It was noted that the NCVHS Quality Workgroup is exploring the topics covered in this session, and that the conversation would continue.

The Committee then recessed for the Quality Workgroup break-out session (see separate minutes), to reconvene on Day Two.

—DAY TWO—

BRIEFING ON DATA ISSUES AND OPPORTUNITIES FROM HURRICANES KATRINA AND RITA—Mr. Scanlon

Mr. Scanlon noted that a report on federal lessons learned has just been released and posted on the White House Website, with 125 recommendations. After the Katrina events, Congress and the White House conducted high-level reviews to identify lessons. A key issue, and a focus of Mr. Scanlon’s briefing, is the key role of data and information technology in future emergency response.

The statute that created the Department of Homeland Security also outlined a National Response Plan specifying local, state and federal roles in large-scale emergencies. Mr. Scanlon noted that plans are always used to the extent possible, but they have to be modified in response to actual events. The first responders are the local community; they have to ask the state for help, and the state has to ask the federal government. HHS is in charge of public health, medical care, and human services and (to a degree) housing.

The Katrina case was different from a typical emergency in that the local infrastructure was largely eliminated. HHS not only provided first-response health and public health services but also facilitated access to human services. It set up field medical contingency stations and augmented medical staffing with 1600 commissioned corps people. In addition, it coordinated a system of some 30,000 volunteer health care workers. Vaccinations were provided free of charge. HHS also worked to help restore the supply chain for medications and other supplies. Most people’s health issues following the hurricane and flood were the same as the ones they had had beforehand. On the public health side, CDC worked with EPA and others to address environmental threats.

Mr. Scanlon then turned to the subject of technology, communication and data. The lack of interoperable communications among first responders is a core issue. People recognize the potential value of EHRs to provide basic information on people’s health history and medications. After Katrina, people were showing up at shelters with normal chronic conditions but without knowledge of their diagnoses or medications. A major issue was the loss of medical records and prescription drugs, and HHS, the Markle Foundation and other organizations, including the pharmaceutical industry, moved in quickly to address this problem using a secure online service. Applying this experience to lessons for the future, there is talk now of creating an “EHR-light” or “first-response EHR” for essential information, and HHS will probably be asked to look into this. (Mr. Houston commented that PHRs would also be useful.)

Turning to data on the “critical health care infrastructure,” Mr. Scanlon noted the importance in response planning to know the daily operational status of local health care and long-term care facilities, and no such national data base exists today. In addition to the denominator problem, basic information on capacity, staffing, and so on is not available. HHS had to rely on first-hand reports and created an ad hoc “Critical Infrastructure Database” for local information. It concluded that having this information, at least on hospitals and emergency departments, on a daily basis would be very useful, and it is looking into how to construct and implement such a database.

Another set of issues concerned access to human services, and HHS worked to remove all administrative barriers for easy access by evacuees to programs such as Medicaid, Medicare, SCHIP and food stamps. The Department was asked to set up an assessment and monitoring system to determine the amount of enrollment, who is on the waiting list, who is receiving what services, and so on, and it produced reports every two days. Mr. Scanlon said something more systematic would be needed to determine and evaluate need, resources and services in future events.

Another needed level of review concerns overall impact, including what happened, where people are now, their situations and their plans. The National Institute of Mental Health does emergency preparedness research and provides tools for the response. It is conducting a major study of 2,000 Katrina victims, collectively called the Hurricane Katrina Community Advisory Group, using quarterly telephone interviews. (Half are inside New Orleans, half are outside.) They will have basic tabulations by April. HHS has invited other federal agencies to participate in this two-year study instead of doing their own surveys. There is a federal interagency workgroup to look at this. The Census Bureau also has been asked for demographic data on the area.

Discussion

Dr. Steinwachs asked Mr. Scanlon to suggest ways for NCVHS sub-groups to be helpful, suggesting a study of mortality data. Mr. Scanlon said the Subcommittee on Populations could help with the question of hospital preparedness, perhaps by organizing a hearing. Where the funds are going is another question. He also suggested receiving a briefing from Dr. Kessler about the NIMH study. He was receptive to the idea of looking at the mortality experience.

Dr. Vigilante commented on the importance of situational awareness and communication to the ability to successfully respond to emergencies, each of which is always unique. The group discussed the possibility of adapting and expanding existing information and communication systems used by local hospitals. Dr. Carr commented on the role the media can play in providing a bigger picture.

In conclusion, Dr. Cohn recognized Mr. Scanlon’s leadership in the relief effort, noting his long hours of work over an extended period of time.

NCHS DATA RELEASE AND CONFIDENTIALITY ISSUES FOR VITAL STATISTICS; BOARD OF SCIENTIFIC COUNSELORS UPDATE—Dr. Sondik and Dr. Elo

On the foregoing topic, Dr. Sondik invited the Committee’s guidance on dynamic emergency capacity for the CDC’s National Center for Public Health Informatics. He described a move from a narrow informatics view of disasters to a broader sense of readiness, and this is compatible with a biosurveillance initiative spearheaded by Dr. Brailer’s office.

Shifting topics, he said that the states, which are the voluntary source of vital statistics, have asked NCHS to review its current policy on releasing the data, out of concern that it conflicts with state laws and regulations. He described current practice and said there has been no known breach. The public use file has a set of restrictions, which he described. Non-federal requests for customized data sets are referred to the research data center, a secure environment. An internal group is reviewing all the data center’s practices. The issue is that the policy may not fit with state laws that prohibit release of any detail, even highly aggregated. NCHS has proposed four types of release to NAPHSIS, the national association for public health information. It is evaluating the utility and value of the national public use data file and compressed files and has offered a proposal, one interpretation of which would require retroactive changes to all public use datasets. Discussions are still under way about this issue.

Dr. Sondik said vital statistics data are the foundation of information on the population’s health and of the work of NCHS and the Department. Thus this is a very serious issue. In response to a question, he said he was unaware of any concern voiced by the public about this issue, which arose about two years ago in the course of HIPAA implementation. Not much has happened in the intervening two years, and this has not yet gone through a legal review. Dr. Sondik suggested that the Committee be briefed again in the future.

Discussion

Dr. Steinwachs noted that the CDC’s center for public health and the law has proactively proposed uniform state laws, and such a thing might be helpful in this situation. Dr. Sondik said he would pursue this idea.

Mr. Reynolds said it would be useful to map this issue to the structure of de-identified information under HIPAA. Dr. Steindel said he thought the NAPHSIS issue had little impact on HIPAA de-identification rules.

Mr. Blair noted the relevance of the work of AHIC’s Health Information Privacy and Security Collaborative, which may provide an opportunity to address these issues, including the variations among state laws. Dr. Sondik also embraced this idea.

Dr. Elo commented that these arose as key issues in the context of the BSC’s review of mortality statistics. The group concluded that there is a possibility of negotiating with the states, and that non-governmental data users should be part of the discussions so state registrars get a better sense of the need for the data. The BSC is recommending a follow-up committee to deal with these state issues, which interact with other legal and policy issues such as preparedness and electronic reporting.

The group agreed that this topic would be a good one for a joint meeting of NCVHS and the BSC. Dr. Cohn asked the Subcommittee on Privacy and Confidentiality to monitor it.

BSC Update

Dr. Sondik said that the BSC had a seven-member panel review the mortality side of NCHS’s work. The process was “terrific” and will serve as a model for future reviews. The report was presented to the BSC, which prepared recommendations for NCHS. He suggested that the Committee be briefed on this in the future. The review endorsed the quality of the Center’s work but recommended several things, including an increased emphasis on the quality of the input and data processing, improvements in access and dissemination, and ways to address confidentiality concerns. The next review will be of the reproductive statistics activity, again using a panel of data users outside NCHS.

Continuing the report, Dr. Elo commented on the Mortality Division’s good job in preparing material for this report. The major themes in the recommendations concern data quality and input, especially on race and ethnicity; confidentiality related to data linkage across data sources; the prospects for electronic death registration; coordination with states regarding state laws; and data access issues. She said joint efforts with NCVHS on data linkage issues would be useful. She added that she had found it beneficial to participate in this NCVHS meeting.

Dr. William Scanlon, the NCVHS liaison to the BSC, said he had similarly found benefit in attending BSC meetings. He noted that the Board addresses subjects that NCVHS focused on in the past, before its charge was broadened. He added that the present NCVHS meeting had illustrated the commonalities between the Committee and the BSC, which share an interest in the potential of IT to get basic information on the health and health care of the American people. Referring to the vital statistics confidentiality issue, he commented that some issues rise to a level of importance that some form of federal inducement may be in order. Finally, he noted the impressive credentials and productivity of the mortality review panel.

Dr. Cohn affirmed that improving population health is the basic purpose of NCVHS, and he thanked Dr. Elo for her participation.

SUBCOMMITTEE AND WORKGROUP REPORTS

Subcommittee on Privacy and Confidentiality—Mr. Houston

Referring back to the discussion of the Subcommittee’s recommendations on privacy and the NHIN, Mr. Houston stressed that the Subcommittee had worked hard to find consensus and common ground on these complex issues, recognizing that “people in good faith will disagree” and that thinking will evolve over time.

Subcommittee on Populations—Dr. Vigilante

The NCVHS report on the collection of race and ethnicity data will be published in early April and disseminated to a list of 2,500 recipients. The Subcommittee is considering hearings on data linkages as well as work on preparedness.

Quality Workgroup—Mr. Hungate

Mr. Hungate thanked the Committee members who joined the very fruitful Quality Workgroup discussion on the previous day. He reported that the Committee’s 2004 recommendation regarding identifying diagnoses present on admission is about to go to the NUBC and NUCC for final action on reporting guidelines. The Workgroup, which is focusing generally on how to assess and improve quality at a population health level and what it means to have a person-centric approach, has yet to develop its specific work plan. Interesting ideas from the previous day’s session include supporting the DOQ-IT program and recommending a demonstration of the use of EHRs to advance public health. Mr. Hungate thanked Susan Kanaan for her assistance in preparing documents for the Workgroup, Debbie Jackson for filling in as lead staff, and Ms. Greenberg for active support. He issued a “plea” for permanent lead staff, the absence of which is undermining the Workgroup’s effectiveness.

FUTURE AGENDAS AND FINAL COMMENTS

Dr. Cohn confirmed that the June full Committee planning retreat would start the afternoon of the 22nd following the full Committee meeting and end the afternoon of the 23rd. He has asked Ms. McCall to help plan the retreat, which will focus on  priorities for a balanced portfolio over the next couple of years. There will be opportunities for self-reflection. Previous chairs will be invited.

The action items for the June full Committee meeting include the Subcommittee on Privacy and Confidentiality report. The group discussed how to use conference calls and other processes prior to the June meeting to facilitate agreement on the privacy report in June—for example, identifying areas of agreement so the major attention can be paid to those requiring more discussion.

There also will be an action from the Subcommittee on Standards and Security. The group discussed how to approach the traditional HIPAA annual report and broader observations in honor of HIPAA’s tenth anniversary, a question the Subcommittee plans to resolve.

The Executive Subcommittee will make decisions on the June agenda.

At Dr. Cohn’s request, members reflected on the foregoing meeting. There was support for having non-overlapping breakout sessions, which enabled an “invaluable” discussion at the Quality Workgroup session. Members expressed appreciation for the chance to share ideas and expertise in this way. The helpful flow from formal presentations to discussions was also noted.

Dr. Cohn then adjourned the meeting.

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

________/s/_______________________________________6/21/2006_______

Chair                                                                                                   Date