Hubert H. Humphrey Building
Washington, D.C.
The National Committee on Vital and Health Statistics was convened on November 5-6, 2003 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
The transcript of this meeting and the text of all approved documents are posted on the NCVHS Web site, www.ncvhs.hhs.gov.
ACTIONS
UPDATE FROM THE DEPARTMENT
Mr. Scanlon reported on the new Council on Application of Health Information Technology, progress on CHI standards, the NAS study of population-based data and race and ethnicity data, the FY2004 budget, the Data Council’s work on geographic information in its data systems and on updating the HHS electronic gateway. The NAS report on the adequacy of race and ethnicity data is expected by March 2004. The results of a recent workshop on race and ethnicity data in the non-public arena have been released.
Since the last NCVHS meeting, the October 16 compliance date has come and gone in “relative quiet,” according to Ms. Freidman. To date, seven complaints have been received. CMS has a policy of getting back to complaint-filers within two weeks with a status update of how the complaint is being handled, and people can also track the status on the Web site.
The Committee passed a motion commending the Department for carrying out such a smooth transition.
Ms. Sanchez reported that OCR has received around 2700 complaints pursuant to the privacy rule, at an average of 100 a week. It has resolved and closed 37 percent of these. 60 percent of the complaints received have been determined not to be in OCR’s jurisdiction, usually because no HIPAA violation is alleged. The top issues are impermissible uses and disclosures and regulated issues of safeguards and minimum necessary. Ms. Sanches also reported on outreach activities through the call center and the Web site.
PRESENTATION BY NCHS DIRECTOR—Dr. Ed Sondik
Dr. Sondik reported on recent progress made by NCHS and the challenges it is facing. He discussed NCHS surveys, health care statistics and vital statistics, with particular attention to reengineering activities and the rapidity with which data are now released. He also reported on budgetary and other challenges, recent activity on summary measures of health, the new NCHS Board of Scientific Counselors (BSC), and the CDC Futures Initiative. He asked for the Committee’s advice on future directions for Health, U.S., a request that was referred to the Subcommittee on Populations.
Dr. Mays, the liaison to the BSC, reported that she is impressed with the expertise and commitment of BSC members. She recommended that the BSC be briefed about NCVHS and that the two groups regularly brief each other on their respective activities.
In the discussion period, NCVHS members raised questions about publicity for NCHS information services, the anticipated impacts of sample size reductions, and getting more attention to mental health issues in summary health measures and other contexts.
ICD-10-CM LETTER—Dr. Cohn
Dr. Cohn presented a letter on the transition to ICD-10-CM and ICD-10-PCS drafted by the Subcommittee on Standards and Security. He read the letter, which summarizes the issues and recommends next steps. After discussion and revisions, the revised letter was approved.
PMRI REPORT— Dr. Cohn, Mr. Blair
Dr. Cohn presented a draft letter on PMRI terminology standard recommendations and a summary prepared by Mr. Blair. Mr. Blair described the work leading up to the present recommendations, noting that as with past recommendations, this is going forward not as a mandate but as an effort to build consensus in the industry and to provide guidance.
The recommendations focus on the core set of concept-oriented central reference PMRI terminologies. The three basic recommendations concern SNOMED CT, the lab portion of LOINC, and federal drug terminologies. After they were read and discussed, the Committee passed a motion approving the letter and recommendations, as revised. Besides editing the document, the discussion focused on how to capture the public health dimension, the need for electronic drug labeling, the intended role of NLM and the need for additional funding to support it, and issues of access and ownership.
CHI UPDATE AND RECOMMENDATIONS — Dr. Cohn
Dr. Cohn read aloud a letter drafted by the Subcommittee on Standards and Security, commenting on a set of CHI domain area recommendations. The Committee passed a motion approving the letter.
Dr. Cohn said that CHI is on a fast track and the Subcommittee will meet with them in early December. Dr. Lumpkin commented on the “historic effort on the part of the Department and CHI” to pick up the pace in the adoption of clinical data standards. The Committee agreed to hold a special meeting at the end of January to take action on further clinical terminology standard recommendations.
DRAFT OF HIPAA 6TH REPORT TO CONGRESS—Dr. Cohn, Mr. Scanlon
Work is underway to produce the 6th iteration of the Committee’s report to Congress on HIPAA implementation, with the goal of approving a final version at the January meeting. The report will cover 2002 and 2003.
ANALYSIS OF ASCA COMPLIANCE PLANS FOR IMPLEMENTING HIPAA TRANSACTIONS AND CODES STANDARDS — Dr. Lumpkin
Dr. Lumpkin stated that as directed by Congress, the Committee had developed and submitted a report analyzing ASCA compliance plans. The report includes the few inferences about best practices that could be drawn at the very preliminary stage of the process at which it was required to be written. The reasons for the report and for its limitations will be discussed in the 2002-2003 report to Congress. The Committee passed a motion approving the posting of this report on the NCVHS Web site.
QUALITY WORKGROUP REPORT—Mr. Hungate
After consultations with NCVHS members, including a recent survey, the Workgroup has decided that its forthcoming report on quality measurement will describe the problems and gaps raised by stakeholders during years of testimony but refrain from making specific recommendations on how to solve them. By highlighting the importance of improving information for quality and summarizing and analyzing the quality measurement issues raised by people in the field, the Workgroup hopes to use its report as a springboard for subsequent discussion within the Committee and with stakeholders (including SDOs) about how to solve the problems and fill the gaps. The possibility of having hearings following the release of the report was discussed.
Dr. Lumpkin explained that the Workgroup is thinking particularly in terms of influencing “what we’re moving towards” as new systems and practices are put in place. He outlined three approaches to improving quality information: 1) adding to the current (administrative) data stream; 2) creating a new and separate data stream, e.g., a quality transaction; and 3) new technology (electronic health records).
Committee members and staff encouraged the Workgroup to complete the report along the lines of this discussion, in order to then use it as a basis for further dialogue and planning.
ISSUES FOR EXECUTIVE SUBCOMMITTEE RETREAT—Dr. Lumpkin
Dr. Lumpkin reviewed the topics on the agenda for the Executive Subcommittee’s November 21 retreat. Members highlighted the need to train new Committee members.
REPORTS FROM SUBCOMMITTEES AND WORKGROUPS; FUTURE AGENDAS
(See detailed summary below for these agenda items.)
NATIONAL CHILD HEALTH LONGITUDINAL STUDY—Peter Scheidt, NICHD
The National Children’s Study will examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. The Children’s Health Act in 2000 authorized NICHD to lead the effort, along with the CDC and the EPA and a consortium of federal agencies. The study is conceived as a longitudinal study of children, their families and their environment, national in scope and covering chemical, physical, behavioral, social, and cultural factors. It is planned as a hypothesis-generated study, while also optimizing the opportunity to look at questions and hypotheses not yet identified.
Dr. Scheidt focused his remarks particularly on study design and sampling issues. The study will include outcomes for underserved, disadvantaged and minority populations; work is ongoing on the question of how much oversampling is needed in order to analyze and interpret outcomes for those populations. Dr. Scheidt described the extensive work being done prior to making sampling decisions to clarify the measures, the purposes of the study, and the core hypotheses. He stressed that the hypothesis development process is a work in progress. To guide sampling decisions, they have proposed an advisory committee. A workshop to consider options and issues, similar to an NIH consensus conference, is scheduled for February 2004. The full study is expected to begin in mid 2006, the first preliminary results are expected in 2009-10, and data collection and analysis will continue from 2007 to 2030. Multi-agency funding exists for the planning phase but funding for the study itself has yet to be determined.
In the discussion period, NCVHS members raised questions about cohort attrition, standardization, sustainability, and the need to examine what kind of study design will not “scare off” potential participants from vulnerable populations.
—DAY ONE—
CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA
Dr. Lumpkin called the meeting to order and asked those present to introduce themselves.
Dr. Huff said he would recuse himself from discussion and voting on anything related to ICD-10-PCS, LOINC or HL7. Dr. Cohn stated that he would recuse himself from discussion and voting on any issues related to CPT. Dr. Lumpkin stated that within the last year, he was briefly on the board of HL7.
UPDATE FROM THE DEPARTMENT
Data Council: Jim Scanlon, ASPE
Mr. Scanlon noted that it has only been six weeks since the last NCVHS meeting. He said the new Council on Application of Health Information Technology, established at the Secretary’s request, is an effort to improve management in this area. Dr. Lumpkin attends to promote cross-fertilization with NCVHS, but the Council’s main purpose is to coordinate HHS activities related to health information technology. All HHS agencies are members, and ASPE and AHRQ chair the group.
Turning to CHI, he noted that since the adoption of the first set of five standards, the CHI Working Group has been looking at additional ones and has forwarded within HHS, DOD and VA several additional candidate standards. The Data Council and the CIO Council recently held a joint meeting at which they were briefed on a suite of CHI standards being considered for adoption, and they reacted favorably. So progress is being made on CHI standards within HHS.
On population-based data and race and ethnicity data, the Congressionally mandated study of the adequacy of race and ethnicity data in and beyond HHS data systems and activities is expected to generate a report by March 2004. The National Academy of Sciences panel working on this held a workshop on race and ethnicity data in the non-public arena, and those results have been released. The issues that arose in the workshop included potential legal ones, pointing to the need to clarify the legal situation and current practices. For public data collection, the priorities have been identified; now, filling the gaps is largely a matter of resources.
Mr. Scanlon noted that because the Department is still existing on a continuing resolution, without a FY2004 budget, it is spending at the previous year’s level and restricted in what it can do. He hopes the final appropriation will include funding for the “very positive” data and NHII initiatives in the original HHS budget, some of which he enumerated. For example, the Secretary hopes to fund demonstrations through AHRQ of interoperable health information technology.
The Data Council is making progress on two projects, one looking at the metadirectory of data systems to determine the availability of geographic information in its data systems and best practices in that area. The other is expanding and updating the HHS electronic gateway to statistics to make it more user-friendly.
Regarding the status of NCVHS recommendations, the Department has replied to most of them to date and two additional draft responses will soon go to the Secretary.
HHS implementation of HIPAA data standards: Maria Friedman, CMS
Since the last NCVHS meeting, the October 16 compliance date has come and gone in “relative quiet,” according to Ms. Freidman. To date, seven complaints have been received. CMS has a policy of getting back to complaint-filers within two weeks with a status update of how the complaint is being handled, and people can also track the status on the Web site.
Dr. Fitzmaurice observed that “the train wreck that was forecast hasn’t occurred.” He asked about the percentage of claims coming into Medicare that are HIPAA-compliant, and Ms. Friedman said the percentage is at 30 percent and moving up. People are taking advantage of the contingency plan provision to work through issues. There have been no reports of big cash-flow problems to date.
Mr. Blair offered a motion that NCVHS commend HHS for taking the lead in working with its numerous partners to carry out the complex and contentious transition to HIPAA codes and transaction standards so smoothly. The motion was seconded and passed unanimously. Ms. Berek observed that given the size of Medicaid, the federal government’s state partners played a major role in the transition.
Privacy Rule compliance update: Linda Sanchez, OCR
Ms. Sanchez reported that OCR has received around 2700 complaints pursuant to the privacy rule, at an average of 100 a week. It has resolved and closed 37 percent of these. No fines have yet been assessed, but a few cases have been referred to the Department of Justice. The top issues are impermissible uses and disclosures and regulated issues of safeguards and minimum necessary. Access continues to be a big concern with complainants, as is the failure to provide notice or adequate notice. Some cases involve authorizations and complaints about policies and procedures.
OCR has run reports on the types of covered entities that are subject to complaints, finding a wide range. The top categories, representing 40 percent of the complaints, are private medical practices, general hospitals and pharmacies, which makes sense as these have the most direct contact with individuals.
On outreach, the OCR/CMS call center has handled 15,000 calls about privacy, with 8,000 calls handled by regional offices. The volume has diminished by a third since the initial influx, to 380 calls a week. The FAQs on the Web site have been accessed 1.4 million times. At Dr. Steinwachs’ request, she described OCR’s process for handling complaints, noting that in general the goal is to work with the covered entity to help them come into voluntary compliance. 60 percent of the complaints received have been determined not to be in OCR’s jurisdiction, usually because no HIPAA violation is alleged.
Discussion
Members and staff asked a variety of questions trying to get a sense of the nature of the complaints and calls to the hotline, and how they are handled. Ms. Friedman said that the hotline attempts to educate callers about the regulations — who is a covered entity, the issues involved with privacy, and so on. Only a fraction of the calls are then transferred to OCR for complaint filing.
Mr. Houston observed that sometimes people with “a general beef” will invoke HIPAA because they think this will generate more attention.
PRESENTATION BY NCHS DIRECTOR—Dr. Ed Sondik
The Center’s programs and activities are in the areas of vital statistics, health status, and the health system. A matrix is available that summarizes the data collection efforts in each category. Highlighting one detail, Dr. Sondik noted that the nation has reached a “tipping point” in its attention to long-available data on increasing obesity in the U.S.
In the area of vital statistics, the reengineering effort (primarily a change to Web-based systems) has resulted in state systems that to the vital statistics community feel “very much alike,” enabling states to pool resources and knowledge. The ongoing work on interoperability and security require funding, but so far NCHS has found funds to move forward, notably from the Social Security Administration. Dr. Sondik highlighted new data on birth and educational attainment for births and deaths, and described the methodology for bridging old and new race/ethnicity categories.
Turning to health care statistics, he discussed recent developments related to ambulatory care and hospital discharge data, noting the new data collection on bioterrorism and mass casualty preparedness and describing other new designs. A priority for the future is developing a better understanding of the long-term care situation. The principal issue with health care statistics, Dr. Sondik said, is maintaining the complement of health care surveys. Resources do not permit doing all of them at the same time, so they are being carefully alternated and combined.
He then discussed recent work and future plans for the National Health Interview Survey and the National Health and Nutrition Examination Survey. The general approach with the NHIS, a change from the past and a considerable achievement, is to do things on a sequenced basis and to get the information out very rapidly. This has been facilitated by a reengineering of the database tools, with staff training. The result is better data quality and timeliness. A more challenging aspect involves the need to cut sample sizes, raising the question of whether this hurts the survey. The Center is experimenting with different approaches and looking at both the fiscal impact and the impact of sample size changes on quality. Major operations research questions are also being studied.
NHANES is on a new schedule, using two-year data sets (compiling representative samples from two years). The survey produces annual figures on diet and nutrition for USDA. Dr. Sondik described a participatory “open technology” process used by the Center to get broad-based input about proposed changes. Contract competition for conducting NHANES is now underway.
Community HANES is now in New York City, using storefront clinics, and is expected to provide a firm baseline on the health of New Yorkers. NCHS receives many inquiries about a self-contained set of Community HANES trailers that can go anywhere.
The new Board of Scientific Counselors, which was formed in consultation with NCVHS, is charged with providing scientific guidance to review intramural research as well as extramural research, working in collaboration with NCVHS (which advises on policy issues). It has held its first meeting, will meet again in January 2004, and four new members are expected in April. Dr. Mays is the NCVHS liaison.
Dr. Sondik stressed the importance of dissemination in the Center’s work, noting that it increasingly uses the Web. His goal is to have a uniform-entry data system for all NCHS data. The Research Data Center provides a mechanism for researchers to access data usually not released to the public because of nondisclosure or confidentiality constraints. He hopes to have several such centers in the future. One NCHS dissemination effort involves support of Healthy People 2010. Another is Health U.S. He asked the Committee to consider future directions for this print publication, including target audiences, who should be involved in a review, what should be reviewed, and what process should be used.
Dr. Sondik briefly commented on the CDC Futures Initiative, whose five goals include ensuring measurable improvement of the public’s health and ensuring a state-of-the-art workforce. He noted that several of the strategic themes of the initiative are consonant with the NCVHS/NCHS/CDC vision for 21st century health statistics.
He enumerated a number of challenges being addressed by the center, namely, reengineering; diminishing response rates; staff development; meeting national, state and local needs; efficient survey and administrative data designs; and sufficient resources for research and development to support health statistics.
Finally, he reported on an expert workshop convened in March 2003 by the DHHS Inter-Agency Working Group on Summary Measures of Health to identify priorities for advancing development, acceptance, and use of these measures. The participants organized the work into seven “themes” which they then formally prioritized. The top two priorities were to compare preference vs. non-preference-based measures and to look at the properties of the instruments. These priorities, which can be viewed on the NCHS Web site, have been referred to the decision-making components of the Department.
Comments on the Board of Scientific Counselors (BSC): Dr. Mays
Dr. Mays said she was impressed with the individuals on the Board in terms of their expertise and commitment, and looked forward to a complementary relationship. She said the group and NCVHS would have to feel their way into a working relationship. She recommended a presentation to the BSC about NCVHS, first to brief them on the Committee and then routinely to update them on the Committee’s activities. Efforts will be made to keep each other apprised of letters, recommendations, and so on.
Discussion
Dr. Steinwachs said he hoped NCHS is getting public visibility and credit for its good work, and he asked what is done to heighten the visibility of the newly available, useful and timely information, such as that on the uninsured. Dr. Sondik said there is an active effort to publicize the availability of data, and he described the Center’s outreach and media relations activities. He added that there are economists on the BSC who provide an important perspective on health statistics.
Asked about the consequences and costs of not being able to update the NHIS sampling frame, Dr. Sondik said he would get back to the Committee with a specific response to that. Dr. Mays asked for a briefing, as well, on the analytic losses resulting from the smaller sampling frame. Dr. Sondik asked for feedback from the Committee on whether the anticipated loss is one data users can live with. It was agreed that these topics will be discussed at a future NCVHS meeting.
On increasing the number of Data Centers, Dr. Mays suggested pursuing with the Census Bureau the possibility of sharing space, within the constraints of Title 13.
Dr. McDonald noted the amount of strikingly good public health news coming from NCHS surveys. He suggested “magnifying the voice about this good news” through other bodies such as hospital associations, medical professions and drug companies. Dr. Sondik agreed, but also called attention to the less good news, notably continuing disparities in infant mortality rates. He hailed the constructive and appropriate framing of the obesity problem as a health issue.
Dr. Steinwachs pointed out the need for greater attention to mental health issues, and asked for a briefing on what NCHS is doing in that area in the future. He and Dr. Sondik exchanged comments about summary measures, how best to represent a broad picture of health, and the need for research on this, adding that information on functioning is another important and neglected dimension.
Dr. Sondik’s request for advice on Health U.S. was referred to the Subcommittee on Populations.
ICD-10-CM LETTER—Dr. Cohn
Dr. Cohn presented a letter on the transition to ICD-10, drafted by the Subcommittee on Standards and Security. He noted that it is the culmination of a multi-year process for the Committee, and has taken a long time because it is “contentious and complex.” A major impediment has been the need to raise the industry’s level of awareness of the issue. The Subcommittee has received written or oral input from more than 80 organizations and individuals, and had eight days of hearings on the issue. The Committee also commissioned an impact study by RAND, presented and discussed at the September full Committee meeting. It also reviewed independently developed reports, including one from Blue Cross/Blue Shield. The Subcommittee recognized its responsibility to synthesize this information and make a judgment about what is best for the country, even in the absence of industry consensus.
Dr. Cohn then read a letter drafted by the Subcommittee, summarizing the issues and recommending next steps. In sum, the Committee recommends that the Department initiate the regulatory process for the concurrent adoption of ICD-10-CM and ICD-10-PCS by issuing an NPRM, with a structured environment for addressing implementation issues and a minimum of two years for implementation.
Members were given the opportunity to comment and suggest revisions. The group agreed on several revisions in the course of reviewing the draft. It was then moved and seconded that the letter and recommendations be adopted, as revised. Before a vote was held, the revised version was projected on the screen for all members to see. The motion passed, with no opposition and Dr. Huff recusing himself.
The full text of the draft letter, discussion and revisions can be found in the transcript of this meeting. It and the text of the letter, as approved, are posted on the NCVHS Web site, www.ncvhs.hhs.gov.
Dr. Lumpkin thanked Dr. Cohn for his work in shepherding through the ICD-10 process. Ms. Berek, the CMS liaison, thanked the Committee for moving the ICD transition forward, noting that “the real work is yet to come” in terms of the rulemaking process and the transition itself. Ms. Greenberg, on behalf of Dr. Sondik, added the thanks of the National Center for Health Statistics.
PMRI REPORT — Dr. Cohn, Mr. Blair
Dr. Cohn presented a draft letter on PMRI terminology recommendation, and a summary prepared by Mr. Blair. Mr. Blair explained that the Committee’s work on patient medical record information and the electronic exchange of that information was mandated by HIPAA in 1996. As directed, the Committee produced a report in August 2000, which outlined a strategy for moving forward with recommendations and served as the foundation for subsequent work. The first recommendations, in February 2002, concerned PMRI message format standards. The Secretary announced in March 2003 that these would be adopted by the federal government, as part of the Consolidated Health Informatics (CHI) initiative and in the context of the NHII.
Recently, the Subcommittee on Standards and Security has been working on PMRI terminology standard recommendations. Mr. Blair described the process, which used a consultant and involved a detailed questionnaire sent to more than 40 terminology developers. The industry advised focusing on a core set of PMRI terminologies, and considerable work was done to pin those down. Consistent with past recommendations, this is not going forward as a mandate but as an effort to build consensus in the industry and to provide guidance.
The recommendations focus on the core set of concept-oriented central reference PMRI terminologies. The three basic recommendations concern SNOMED CT, the lab portion of LOINC, and federal drug terminologies. Mr. Blair briefly described the elements of the report and recommendations.
Dr. Cohn then read the recommendations aloud, pausing for discussion of each component of the recommendations.
Dr. Mays, Dr. Steindel and others engaged in a discussion about how to capture the public health dimension. Dr. Lumpkin noted that SNOMED is just one “piece of the puzzle.” Ms. Greenberg said the Public Health Data Standards Consortium is sponsoring a forthcoming AMIA session on public health vocabulary. Dr. Cohn observed that part of what CHI is about is figuring out what pieces need to be put together, and how to do so to make things work.
Among other topics briefly raised and discussed was the need for electronic labeling for drugs. Dr. Cohn said the Subcommittee on Standards and Security wants the FDA to brief it on its terminology model and the plans for making it happen.
Members discussed issues related to coordinating and mapping the core PMRI terminologies to related terminologies, in particular the urgency of doing so and the need for funding to support this task. The letter recommends that the National Library of Medicine be designated as the body to do the coordination and integration. It was noted that this will be an ongoing process. The Committee agreed to recommend additional funding to NLM to carry out its recommended tasks expeditiously.
Mr. Localio raised the issues of access and ownership. Dr. Steindel said that everything being recommended for the core is freely available, although not in the public domain. The issue of mapping depends on the licensing terms. Mr. Blair said that NCVHS set out in its initial guiding principles for PMRI standards that they be available at little or no cost. However, the group agreed that this should not be stated as a condition of the current recommendations, partly because of the complexity of the issue and because the guiding principle has already been declared.
With Dr. Huff and Dr. McDonald recusing themselves, the Committee passed a motion that the aforementioned letter and recommendations be moved forward with the agreed-upon changes.
Dr. Cohn thanked Mr. Blair for his “wonderful and amazing” leadership in moving this project forward. Mr. Blair, in turn, thanked Dr. Steindel for his critical role and Dr. Sujansky and Dr. Fitzmaurice for their contributions.
CHI UPDATE AND RECOMMENDATIONS — Dr. Cohn
Dr. Cohn read aloud a letter drafted by the Subcommittee on Standards and Security commenting on a set of CHI domain area recommendations. The Committee passed a motion, with no opposition or abstentions, approving the letter.
By way of an update, Dr. Cohn said that CHI is on a fast track and the Subcommittee will meet with them in early December. There are 13 additional domains to review, and he raised the question of whether the Committee should wait until its March meeting to take action on these. Dr. Lumpkin stated that in view of impending changes in the Committee, the importance of the actions needed, and the “historic effort on the part of the Department and CHI” to pick up the pace in the adoption of clinical data standards, an additional full NCVHS meeting in late January is in order. (The special meeting will take place on January 29.)
Dr. Lumpkin called attention to the momentous significance of the decisions reached by the Committee on this day, reflecting a “really true partnership” between the Committee and people in the federal government. These actions will have a great impact on accelerating the transformation of health care. The group also applauded Jared Adair, the newly retired leader of the CHI, and she thanked the Committee for its help.
DRAFT OF HIPAA 6TH REPORT TO CONGRESS—Dr. Cohn, Mr. Scanlon
Dr. Cohn said work was underway to produce the 6th iteration of the Committee’s report to Congress on HIPAA implementation, with the goal of approving a final version at the January meeting.
Mr. Scanlon noted that the report covers topics relevant to virtually all NCVHS subcommittees and workgroups. He explained that the usual cut-off date for the period being reported on has been extended to encompass the effective dates for the privacy and transaction code set rules. The current thinking is to have the report cover the calendar years 2002 and 2003. He reviewed the topics to be covered. He asked if the Committee wanted this to be simply a factual report or to include an intepretive discussion as well.
Dr. Lumpkin urged that the report include the activity on the Hill related to the NHII and generally put HIPAA activities in the context of the NHII and how it has moved the NHII agenda forward.
Mr. Blair noted the morphing of PMRI, in its implementation in the federal health care sector, into CHI standards, and raised the question of appropriate terminology. Dr. Lumpkin stressed that for the report to Congress, what is significant is that CHI represents the carrying out of HIPAA legislation. This led to a general discussion of the place of clinical standards with respect to the Committee’s mandate, the NHII, and HIPAA legislation. Ms. Greenberg stated that the Committee’s PMRI recommendations, which were mandated by HIPAA, go beyond the CHI process and can provide guidance for the entire health care industry.
Dr. Cohn noted the concern of some “major payers” that in its effort to “distance the concept of NHII from HIPAA,” HHS is “turning its back on” some of the important things that HIPAA has provided. This suggests, he said, that the Committee needs to recognize the importance of HIPAA to the industry and to be clear about the synergy among all these elements. Mr. Scanlon observed that the Committee views HIPAA as one of the elements of the NHII. PMRI is its “toehold to get into clinical data standards and interoperability standards,” which are manifested in the federal domain through the CHI.
Mr. Houston urged that the Committee try to draw some conclusions, or identify issues, that have emerged from recent NCVHS hearings on privacy.
ANALYSIS OF ASCA COMPLIANCE PLANS FOR IMPLEMENTING HIPAA TRANSACTIONS AND CODES STANDARDS — Dr. Lumpkin
Dr. Lumpkin noted that the Committee had developed and submitted this report analyzing ASCA compliance plans, as required. The report, authored by Drs. Fitzmaurice and Steindel, includes the few inferences about best practices that could be drawn at the very preliminary stage of the process at which it was required to be written. The reasons for the report and for its limitations will be discussed in the aforementioned 2002-2003 report to Congress. The Committee passed a motion approving the posting of this report on the NCVHS Web site.
Members then recessed into Workgroup sessions.
—DAY TWO—
QUALITY REPORT—Mr. Hungate
Mr. Hungate said the Quality Workgroup is making progress in understanding the task before it as well as the thinking of the Committee. This is partly due to the recent survey, completed by seven members, Ms. Greenberg and Dr. Steindel. Summarizing the findings, he said that with a few exceptions, “most people on most things” favor acting sooner rather than later, view the identified issues as important, and for the most part regard the solutions as “not quite as hard as they are important.”
Nevertheless, the overall conclusion reached by the Workgroup, based on previous Committee discussions and the survey, is that there is no consensus on the Committee in support of specific solutions. Therefore the report will describe the quality measurement problems and gaps raised by stakeholders during years of testimony but refrain from making specific recommendations on how to solve them. By highlighting the importance of improving information for quality and summarizing and analyzing the quality measurement issues raised by people in the field, the Workgroup hopes to use its report as a springboard for subsequent discussion within the Committee and with stakeholders about how to solve the problems and fill the gaps.
Mr. Hungate asserted that an overarching goal must be to “change the health care system from a cost-driven system to a quality-driven system.” Mr. Blair proposed that it is unnecessary to regard these two motivations as mutually exclusive, since in the information age, improving quality can reduce cost.
Dr. Cohn, Dr. Zubeldia and other members stressed the importance of getting public input—particularly from those who must supply the data and from standards development organizations—on the most feasible ways to fill quality measurement data gaps. Mr. Hungate explained that some of the testimony to date represents the perspective of purchasers who are “trying to change the way we spend our dollars in health care.” The group discussed the possibility of having hearings following the release of the report, to elicit input from other perspectives.
Dr. Zubeldia expressed confusion about whether the target of the report is “quality of care, quality of data, or quality of payment.” He observed that providers, not payers, contribute data to public repositories for analysis, and he stressed that besides data collection and reporting, attention must be paid to providing a mechanism to harvest the data going to payers.
Dr. Lumpkin explained that the Workgroup is thinking less in terms of influencing current systems and practices, and more in terms of influencing “what we’re moving towards” as new systems and practices are put in place. He outlined three approaches to improving quality information: 1) adding to the current (administrative) data stream; 2) creating a new and separate data stream, e.g., a quality transaction; and 3) new technology (electronic health records). For any specific gap or need, the solution may lie in one, two, or all three of these areas.
Dr. Zubeldia and Huff observed that some of what is envisioned for the second and third of these categories is already in place. They cautioned against using payment systems as the mechanism for conveying data whose primary relevance is for quality. Ms. Berek countered that in her experience, data that do not impact on payment are not entered correctly, and “linking the things you need for quality to the way you pay sometimes helps get what you need.” She agreed, however, that there must be “a long, involved, and very publicly inclusive discussion on this subject.”
Generally, Committee members and staff encouraged the Workgroup to complete the report along the lines of this discussion, i.e., describing quality measurement improvement goals and barriers without being prescriptive about solutions. The more specific recommendations in the latest draft will be rephrased as examples of ways to fill the critical gaps that were identified in testimony. The report can then be used as a basis for further dialogue (for example, with X-12) and in planning the Workgroup’s next steps.
Mr. Blair urged that the report include a clear definition of quality, encompassing costs, responsiveness, access, and the nature of the care. Further, the report should say that the NHII can facilitate quality improvement.
ISSUES FOR EXECUTIVE SUBCOMMITTEE RETREAT—Dr. Lumpkin
The Executive Subcommittee will hold a one-day retreat on November 21. Topics include these:
REPORTS FROM SUBCOMMITTEES AND WORKGROUPS
NHII Workgroup—Dr. Lumpkin
The Workgroup will hold an all-day meeting in December for the purpose of assessment and planning. Among other things, it will review the 2001 NHII recommendations for their pertinence today and consider how best to move the agenda forward.
Subcommittee on Standards and Security—Dr. Cohn
Hearings are scheduled for early December and late January, covering CHI, the current status of HIPAA standards and recommended changes, and claims attachments. A half-day during the January hearing will focus on the security final rule.
Subcommittee on Privacy and Confidentiality—Dr. Harding
Privacy hearings will be held on November 19 and 20 on the impact of privacy rule implementation on public health and on health services research, plus a general open session. On February 3-4 (subsequently rescheduled for February 18-19), testimony will be taken on schools, law enforcement, and payment chains. An additional hearing on implementation will be held in 2004.
Referring to a letter in the American Medical News, Dr. Harding said the Subcommittee had sought clarification on whether there were provisions for small practices to “opt out” of the electronic practices that make them covered entities under HIPAA. The government’s response is that there is no provision for opting out after the fact. HHS legal staff are also looking into the extent to which Graham-Leach-Bliley, a bill directed at the banking industry, applies to HIPAA transactions.
Dr. Lumpkin observed that the issue of out-of-country medical records warrants attention. Mr. Blair commented that the broader issue is subcontracting in general, regardless of where the work is done. Mr. Houston noted that services other than transcription are going off shore, with further privacy implications.
Ms. Berek suggested that the Subcommittee look at identity theft relating to health care. Mr. Houston suggested looking at the related issue of the uses and abuses of Social Security numbers in health care. Dr. Steindel said the NHII Workgroup has received testimony on identity theft. In response to a question, Mr. Scanlon said that as of the FY2003 budget, the Department is still prohibited by Congress from spending any funds on the development or promulgation of a unique patient identifier. It will monitor this question relative to the 2004 budget.
Subcommittee on Populations—Dr. Mays
The Subcommittee is following up on the two letters passed in September, one on targeted surveys and the other on encouraging health plans to collect race and ethnicity data. On the first, with the help of NIH liaison Virginia Cain, NIH is pulling together a group to plan a small workshop to get broad input on methodological issues for targeted surveys. On the second, the plan is to send a copy of the letter to the hundreds of existing health plans and to trade associations.
The Workgroup will hold a hearing in mid-November in San Francisco on the OMB directive with respect to Asian, Native Hawaiian and other Pacific Islander population groups. Participants will be asked what kind of data they would like to see.
The Subcommittee also is starting to give significant attention to the subject of mental health statistics. Dr. Mays noted that the NIMH decision to withdraw support from NHANES mental health statistics collection has raised serious issues. Mental health needs to be included in the definition of quality of life; furthermore, the availability of biologic data in NHANES would be very useful in relation to self-report data on mental health. The Subcommittee wants to look at mental health statistics and surveillance at the Departmental level, and at how we are thinking about health. The short-term goal is to deal with NHANES and talk with NIMH about possibly funding collection of mental health data in NHANES 2005.
The Subcommittee will advise the full Committee and NCHS, as requested, on a review of Health, US and its uses. And it plans to look into possible ways to increase data access while maintaining privacy protections, in collaboration with the Subcommittee on Privacy and Confidentiality. Geocoding is also on its agenda, along with the production of two reports in 2004, based on recent hearings.
AGENDA ITEMS FOR FORTHCOMING NCVHS MEETINGS
These items were mentioned for the March or June 2004 full Committee meeting:
NATIONAL CHILD HEALTH LONGITUDINAL STUDY—Peter Scheidt, NICHD
The National Children’s Study will examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. Dr. Scheidt said that as requested, he would focus on study design and sampling issues in his remarks, with particular reference to concerns about health disparities.
The study began with a proposal from the President’s Task Force on Health Risks and Safety Risks to Children. The task force was formed in 1997 and charged with developing strategies to reduce and control the risks to children of environmental exposures, broadly defined. Concern about known measured exposures plus the existence of neurocognitive and physical conditions for which little is known about possible environmental exposures were both part of the rationale for the study. It has been embraced by the current administration. The Children’s Health Act in 2000 authorized NICHD to lead the effort, along with the CDC and the EPA and a consortium of federal agencies. There will also be extensive public-private partnerships for sub-studies, sub-analyses and adjunct studies.
The study is conceived as a longitudinal study of children, their families and their environment, national in scope and covering chemical, physical, behavioral, social, and cultural factors. It is designed to include a look at outcomes that are “burdensome but infrequent,” and it will be able to examine the interactions of environment and genetic expression. It is made possible by state-of-the-art technology. It is planned as a hypothesis-generated study, while also optimizing the opportunity to look at questions and hypotheses not yet identified.
Dr. Scheidt then discussed sample design and sampling issues. He said sampling questions emerged as a very important consideration soon after project planning began. The issues include the degree to which representativeness is essential, the need to enroll women pre-pregnancy as well as early in pregnancy, and how much oversampling of sub-populations is needed. The study will include outcomes for underserved, disadvantaged and minority populations; the question is how much oversampling is needed in order to analyze and interpret outcomes for those populations. Other populations for oversampling include agriculturally exposed and highly industrially exposed, and these need to be looked at with respect to community and neighborhood attributes. At the same time, changes over time must be allowed for. There are also questions about whether data can be gathered by phone, when participants need to visit a medical center for complex measures, and so on.
NCHS and WESTAT conducted a pilot to suggest alternative ways to sample pregnant women. They proposed three major models—a household model, an office-based model, and a medical center model—and analyzed the advantages of each. A panel studied the analysis and concluded that much greater clarity is needed about the measures, the purposes of the study, and the core hypotheses, and that the lead sampling strategies would require field feasibility testing. These efforts have been underway over the last year. It was stipulated that testable, important and answerable hypotheses should be required for costly elements of the study, and there should be longitudinal follow-up. The hypotheses meeting these criteria were organized into five priority outcome areas:
Dr. Scheid stressed that the hypothesis development process is a work in progress. Not all of the existing ones will necessarily stay as the study design evolves, and others will be included. But the initial set is being used to start framing the study and to guide thinking about issues such as sampling.
To guide sampling decisions, they have proposed an advisory committee, and a workshop to consider options and issues, similar to an NIH consensus conference, is being planned. For background materials, they have defined a set of white papers on methodological issues. One option emerging for examination is the notion of a hybrid of components “that may not be a pure and simple one-type of sample.” The papers are due in January, and the workshop is scheduled for February 2004, with a report to the interagency coordinating committee and advisory committee due in March. The NIH director will be involved in the decisions, and feasibility studies are planned for the second half of 2004.
About 30 pilot studies are underway, several of which Dr. Scheid outlined, and multiple workshops are scheduled. He noted that this large longitudinal study may be able to contribute to understanding childhood cancer by providing a control group for the National Childhood Cancer Registry and by collecting biomarkers and genetic markers.
Turning to NCVHS concerns about health disparities, he noted that this is an ongoing part and key feature of the planning process, and a priority that was specified in the Children’s Health Act of 2000. One working group, on Environmental Justice, is dedicated to looking at a range of issues in this area, including the effects of racism on outcomes.
The full study is expected to begin in mid 2006, the first preliminary results are expected in 2009-10, and data collection and analysis will continue from 2007 to 2030.
The Web site for the National Children’s Study: http://nationalchildrensstudy.gov
Discussion
At Dr. Lengerich’s request, Dr. Scheidt discussed the project’s thinking about follow-up and attrition. There is a working group dedicated to this, and pilot studies are focusing on it. He stressed that the expectation is that the government will fund this project, but when asked about contingency plans in the event of budget cuts, he tells people that the first compromise would be on the number of measures, the second on the frequency of visits, and last on maintaining the cohort and follow-up.
Dr. Lumpkin raised standardization issues and asked about the extent to which the data in the system will be comparable because of the use of coding systems compatible with the NHII and HIPAA. Dr. Scheidt said processes and people are in place to deal with these issues. After being advised of the CHI initiative and the standards being adopted through that process, he said he would follow up with them. (He was advised to contact Amy Patterson at NIH.)
Asked about funding, he said there is multi-agency funding for the planning phase but the funding to do the study has yet to be determined.
Noting the need to examine that people in vulnerable populations are more or less likely to participate depending on the sample design, Dr. Mays commented on the apparent absence of papers on “whether or not the people will fit the methods.” She asked if there has been thinking about how not to “scare off” potential participants, and the implications for study design. Dr. Scheidt assured her that there was a lot of thinking about this, but no conclusions yet. Asked about languages, he said there would be a Spanish translation for sure and consideration is being given to Chinese, Thai, and Russian, among others.
In response to another question, he said discussions were initiated 18 months ago to establish a public use data set for this study. “Waves” of such data sets are anticipated and priority will be given to releasing the data as quickly as possible.
Finally, in a dialogue with Ms. Paisano of the Indian Health Service, he said there is a commitment to addressing both exposures and outcomes with American Indians and Alaskan Natives, notwithstanding the challenging sampling and political issues (given 561 tribal governments). Ms. Paisano also pointed out that all American Indian and Alaska Native languages are oral languages, not written.
With this, Dr. Lumpkin 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, M.D. 03/01/2004
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Chair Date